JP7811235B2 - Pump assembly and system for inducing negative pressure within a portion of a patient's urinary tract - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of U.S. Patent Application No. 16/640,210, filed February 19, 2020, entitled "Indwelling Pump for Facilitating Removal of Urine from the Urinary Tract," which is the U.S. national stage of International Application No. PCT/IB2018/056444, filed August 24, 2018, and claims the benefit of U.S. Provisional Patent Application No. 62/550,259, filed August 25, 2017, each of which is incorporated herein by reference in its entirety.

This application also claims priority to U.S. Provisional Patent Application No. 62/837,513, filed April 23, 2019, entitled "Implantable Pump for Inducing Negative Pressure in a Portion of a Urinary Tract of a Patient," the disclosure of which is incorporated herein by reference in its entirety.

(Technical field)
The present disclosure relates to pumps configured to be deployed within a patient's body, and in particular to pumps that may be integrated with systems for inducing negative and/or positive pressure within the patient's bladder, ureters, and/or kidneys.

(background)
The renal or urinary system comprises a pair of kidneys, each connected by a ureter to the bladder and a urethra through which fluid or urine produced by the kidney is expelled from the bladder. The kidneys perform several important functions for the human body, including filtering blood and eliminating waste products in the form of urine. The kidneys also regulate electrolytes (e.g., sodium, potassium, and calcium) and metabolites, blood volume, blood pressure, blood pH, body fluid volume, red blood cell production, and bone metabolism. A proper understanding of the anatomy and physiology of the kidney is useful for understanding the effects of altered hemodynamics and other conditions of fluid overload on its function.

In normal anatomy, the two kidneys are located retroperitoneally within the abdominal cavity. The kidneys are bean-shaped, encapsulated organs. Urine is formed by the nephron, the functional unit of the kidney, and then flows through a system of converging tubules called collecting ducts. The collecting ducts join together to form the minor and then major calyces, which finally join near the concave part of the kidney (the renal pelvis). The primary function of the renal pelvis is to direct urine flow to the ureters. From the renal pelvis, urine flows into the ureters, tubular structures that carry urine from the kidneys to the bladder. The outer layer of the kidney is called the cortex and is a rigid, fibrous capsule. The interior of the kidney is called the medulla. The medullary structures are arranged in a pyramidal shape.

Each kidney consists of approximately one million nephrocytes. Each nephrocyte contains a glomerulus, a Bowman's capsule, and a tubule. The tubule contains a proximal convoluted tubule, a loop of Henle, a distal convoluted tubule, and a collecting duct. The nephrocytes contained within the outer cortical layer of the kidney have a distinctly different anatomy from those contained within the medulla. The primary difference is the length of the loop of Henle. Medullary nephrocytes contain longer loops of Henle, which, under normal circumstances, allows for better regulation of water and sodium reabsorption than outer nephrocytes.

The glomerulus is the origin of the renal unit and is responsible for the initial filtration of blood. The afferent arteriole passes blood into the glomerular capillaries, where hydrostatic pressure pushes water and solutes into Bowman's capsule. Net filtration pressure is expressed as the hydrostatic pressure in the afferent arteriole minus the hydrostatic pressure in Bowman's space minus the osmotic pressure in the efferent arteriole.
Net filtration pressure = hydrostatic pressure (afferent arteriole) - hydrostatic pressure (Bowman's space) - osmotic pressure (efferent arteriole) (Equation 1)

The magnitude of this net filtration pressure, defined by Equation 1, determines the amount of ultrafiltrate formed in Bowman's space and delivered to the renal tubule. The remaining blood exits the glomerulus via the efferent arteriole. Normal glomerular filtration, i.e., delivery of ultrafiltrate into the renal tubule, is approximately 90 ml/min/1.73 ^m2 .

The glomerulus has a three-layer filtration structure, comprising the vascular endothelium, the glomerular basement membrane, and podocytes. Normally, large proteins such as albumin and red blood cells are not filtered into Bowman's space. However, elevated glomerular pressure and mesangial expansion result in surface area changes on the basement membrane, and larger fenestrations between podocytes allow larger proteins to pass into Bowman's space.

Ultrafiltrate collected in Bowman's space is first delivered to the proximal convoluted tubule. Water and solute reabsorption and secretion within the tubule are achieved through a combination of active transport channels and passive pressure gradients. The proximal convoluted tubule normally reabsorbs most of the sodium chloride and water, as well as nearly all of the glucose and amino acids filtered by the glomerulus. The loop of Henle has two components designed to concentrate waste products in urine. The descending limb is highly water-permeable and reabsorbs most of the remaining water. The ascending limb reabsorbs 25% of the remaining sodium chloride, producing concentrated urine, e.g., in terms of urea and creatinine. The distal convoluted tubule normally reabsorbs a small percentage of sodium chloride, and the osmotic gradient results in water following suit.

Under normal conditions, net filtration is approximately 14 mmHg. The effects of venous congestion can significantly reduce net filtration to approximately 4 mmHg. See Jessup M., *The Cardiorenal Syndrome: Do We Need a Change of Strategy or a Change of Tactics?*, JACC 53(7):597-600, 2009 (hereafter "Jessup"). The second filtration step occurs in the proximal tubule. The majority of urinary secretion and absorption occurs in tubules within the medullary renal unit. Active transport of sodium from the tubule into the interstitial space begins this process. However, hydrostatic forces govern the net exchange of solutes and water. Under normal circumstances, 75% of sodium is thought to be reabsorbed into the lymphatic or venous circulation. However, because the kidneys are encapsulated, they are sensitive to changes in hydrostatic pressure from both venous and lymphatic congestion. During venous congestion, sodium and water retention can exceed 85%, further prolonging renal congestion. Verbrugge et al., *The kidney in congestive heart failure: Are natriuresis, sodium, and diuretics really the good, the bad, and the ugly?* See European Journal of Heart Failure 2014:16, 133-42 (hereinafter "Verbrugge").

Venous congestion can lead to prerenal forms of acute kidney injury (AKI). Prerenal AKI results from loss of perfusion (or loss of blood flow) through the kidney. Many clinicians focus on the lack of flow into the kidney due to an acute circulatory failure state. However, there is evidence that lack of blood flow from the organ due to venous congestion can also be a clinically significant and lasting injury. See Damman K, Importance of venous congestion for worsening renal function in advanced decompensated heart failure, JACC 17:589-96, 2009 (hereinafter "Damman").

Prerenal AKI occurs across a variety of diagnoses and requires critical care hospitalization. The most prominent hospitalizations are for sepsis and acute decompensated heart failure (ADHF). Additional hospitalizations include cardiovascular surgery, general surgery, cirrhosis, trauma, burns, and pancreatitis. The symptoms of these disease states vary widely in clinical manifestations, but a common denominator is elevated central venous pressure. In ADHF, elevated central venous pressure caused by heart failure leads to pulmonary edema and subsequent respiratory distress, ultimately prompting hospitalization. In sepsis, elevated central venous pressure is primarily the result of massive fluid resuscitation. Regardless of whether the primary insult was hypovolemia or hypoperfusion due to sodium and fluid retention, the persistent insult is venous congestion, resulting in inadequate perfusion.

Hypertension is another widely recognized condition that results in perturbations within the renal active and passive transport systems. Hypertension directly affects afferent arteriolar pressure, resulting in a proportional increase in net filtration pressure within the glomerulus. The increased filtration rate also elevates peritubular capillary pressure, which stimulates sodium and water reabsorption. See Verbrugge.

Because the kidney is an encapsulated organ, it is sensitive to pressure changes within the medullary pyramids. Increased renal venous pressure leads to stasis, which increases interstitial pressure. Increased interstitial pressure exerts forces on both the glomerulus and tubule. See Verbrugge. In the glomerulus, increased interstitial pressure directly opposes filtration. Increased pressure increases interstitial fluid, thereby increasing hydrostatic pressure in the interstitial fluid and peritubular capillaries within the renal medulla. In both cases, hypoxia can ensure cellular injury and further loss of perfusion. The net result is further deterioration of sodium and water reabsorption, resulting in negative feedback. See Verbrugge (133-42). In particular, intraperitoneal fluid volume overload is associated with many diseases and conditions, including elevated intraperitoneal pressure, abdominal compartment syndrome, and acute renal failure. Volume overload can be addressed through renal replacement therapy. Peters, C. D., Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartanon Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled One-Year Intervention Trial (the SAFIR Study), PLoS ONE (2015) 10(6): e0126882. See doi:10.1371/journal.pone.0126882 (hereinafter "Peters"). However, such clinical strategies do not provide improvement in renal function in patients with cardiorenal syndrome. See Bart B, Ultrafiltration in decompensated heart failure with cardiorenal syndrome, NEJM 2012;367:2296-2304 (hereinafter "Bart").

In light of these problematic effects of fluid retention, systems and methods are needed to improve the removal of fluids, such as urine, from patients and to increase the quantity and quality of fluid output from the kidneys.

(summary)
According to an embodiment of the present disclosure, a pump assembly for increasing urine output from a patient includes at least one ureteral catheter configured to be positioned within the patient's kidney, renal pelvis, and/or ureter, the at least one ureteral catheter including a distal portion including a retention portion and a proximal portion including a drainage lumen. The retention portion includes at least one drainage port that allows fluid flow into the drainage lumen. The pump assembly further includes a pump configured to provide negative pressure to at least one of the renal pelvis or kidney through the drainage lumen of the at least one ureteral catheter. The pump includes at least one fluid port in fluid communication with the drainage lumen of the proximal portion of the ureteral catheter to receive fluid from the patient's kidney, at least a portion of the pump configured to be positioned within the patient's body.

According to another embodiment of the present disclosure, a system for increasing urine output from a patient includes a pump assembly. The pump assembly includes at least one ureteral catheter configured to be positioned within the patient's kidney, renal pelvis, and/or ureter, the pump assembly including a distal portion including a retention portion and a proximal portion including a drainage lumen. The retention portion includes at least one drainage port that allows fluid flow into the drainage lumen. The pump assembly further includes a pump configured to provide negative pressure to at least one of the renal pelvis or kidney through the drainage lumen of the at least one ureteral catheter. The pump includes at least one fluid port in fluid communication with the drainage lumen of the proximal portion of the ureteral catheter to receive fluid from the patient's kidney, at least a portion of the pump configured to be positioned within the patient's body. The system further includes a controller in wired or wireless communication with the pump of the pump assembly, the controller configured to direct operation of the pump and control the flow rate of fluid passing through the fluid conduit of the pump.

According to another embodiment, a method for treating a patient by providing negative pressure therapy to a portion of the patient's urinary tract includes positioning a pump of a pump assembly in a deployed position within the patient's body. The pump assembly includes at least one ureteral catheter configured to be positioned within the patient's kidney, renal pelvis, and/or ureter, the pump including a distal portion including a retention portion and a proximal portion including a drainage lumen. The retention portion includes at least one drainage port that allows fluid flow into the drainage lumen. The pump assembly further includes a pump configured to provide negative pressure to at least one of the renal pelvis or kidney through the drainage lumen of the at least one ureteral catheter. The pump includes at least one fluid port in fluid communication with the drainage lumen of the proximal portion of the ureteral catheter to receive fluid from the patient's kidney, at least a portion of the pump configured to be positioned within the patient's body. The method further includes establishing fluid communication between the pump and the drainage lumen of the at least one ureteral catheter, and activating the pump, thereby causing the pump to provide negative pressure through the drainage lumen of the at least one ureteral catheter to the patient's ureter, renal pelvis, and/or kidney.

Non-limiting examples of the present invention will now be described in the following numbered appendices.

Appendix 1: A pump assembly for increasing urine output from a patient, comprising: (a) at least one ureteral catheter configured to be positioned within the patient's kidney, renal pelvis, and/or ureter, the at least one ureteral catheter comprising a distal portion including a retention portion and a proximal portion including a drainage lumen, the retention portion including at least one drainage port that allows fluid flow into the drainage lumen; and (b) a pump configured to provide negative pressure to at least one of the renal pelvis or kidney through the drainage lumen of the at least one ureteral catheter, the pump including at least one fluid port in fluid communication with the drainage lumen of the proximal portion of the ureteral catheter to receive fluid from the patient's kidney, at least a portion of the pump configured to be positioned within the patient's body.

Appendix 2: The pump assembly of Appendix 1, wherein at least a portion of the pump is configured to be positioned within the patient's urinary tract.

Appendix 3: The pump assembly of Appendix 1, wherein at least a portion of the pump is configured to be implanted within the patient's body outside the urinary tract.

Appendix 4: A pump assembly according to any one of Appendices 1-3, wherein the pump comprises a housing defining an opening for at least one fluid port, and a pump chamber at least partially enclosed within the housing fluidly connected to the at least one fluid port, the pump configured to draw fluid through the drainage lumen of the at least one ureteral catheter into the pump chamber, thereby exerting a negative pressure on at least a portion of the interior of the kidney and/or renal pelvis.

Appendix 5: A pump assembly according to any one of Appendices 1, 3, and 4, wherein the at least one fluid port comprises an inflow port and an outflow port, and the pump assembly further comprises at least one outflow catheter in fluid communication with the outflow port, the outflow catheter configured to conduct fluid received from the drainage lumen of the at least one ureteral catheter away from the pump.

Appendix 6: The pump assembly of Appendix 5, wherein the outflow catheter has a first end connected to the outflow port of at least one fluid port of the pump, and a second end configured to be positioned within the patient's bladder to drain fluid into the bladder or positioned outside the patient's urinary tract and to drain urine from the patient.

Appendix 7: The pump assembly of Appendix 5 or Appendix 6, wherein a portion of at least one ureteral catheter is positioned within the lumen of at least one outflow catheter.

Appendix 8: The pump assembly of Appendix 7, wherein a portion of the at least one ureteral catheter positioned within the lumen of the at least one outflow catheter is configured to extend through an opening in the patient's bladder wall.

Appendix 9: The pump assembly of any of Appendices 5-8, further comprising a tubular shunt configured to extend through the patient's bladder wall, wherein portions of the at least one ureteral catheter and the at least one outflow catheter are positioned within the lumen of the tubular shunt.

Appendix 10: A pump assembly described in any of Appendices 5-9, wherein the inflow port is configured to receive a first end of at least one ureteral catheter, and the outflow port extends at least partially around the inflow port.

Appendix 11: A pump assembly described in any of Appendices 1-10, wherein the pump comprises at least one of a rotary pump, a rotary dynamic pump, or a positive displacement pump.

Appendix 12: The pump assembly of any of Appendices 1-11, wherein the retention portion of at least one ureteral catheter comprises a periphery or protective surface area that, in response to application of negative pressure through the catheter, prevents mucosal tissue from occluding one or more protected drainage holes, ports, or perforations located within the periphery or protective surface area.

Appendix 13: The pump assembly of Appendices 12, wherein the retention portion comprises a coil, and wherein one or more protected drain holes, ports, or perforations extend through a radially inward-facing portion of the sidewall of the coil.

Appendix 14: A pump assembly described in any of Appendices 1-13, wherein the pump is configured to provide a negative pressure ranging from 0 mmHg to approximately 150 mmHg to the drainage lumen of at least one urinary catheter, as measured at at least one fluid port of the pump.

Appendix 15: The pump assembly of any of Appendices 1-14, wherein the pump is configured to generate sufficient negative pressure within the ureter, renal pelvis, and/or kidney to establish a pressure gradient across the glomerulus of the patient's kidney and promote urine flow toward the drainage lumen of at least one ureteral catheter.

Appendix 16: A pump assembly described in any of Appendices 1-15, wherein the pump includes a battery.

Appendix 17: The pump assembly of Appendices 16, wherein the pump further comprises an induction coil electronically coupled to the battery for providing power to the pump and for recharging the battery.

Appendix 18: The pump assembly of Appendix 17, wherein the induction coil is configured to generate electrical power when exposed to an electromagnetic field generated by a remote device positioned outside or within the patient's body.

Appendix 19: A pump assembly as described in Appendix 17 or Appendix 18, wherein the induction coil comprises a conductive wire that is at least partially disposed on the flexible sheet.

Appendix 20: The pump assembly of any of Appendices 1-19, further comprising an external controller positioned outside the patient's body, the external controller electrically coupled to the pump and providing power to the pump.

Appendix 21: The pump assembly of Appendix 20, further comprising at least one electrical cable extending between the external controller and the pump through at least one percutaneous access opening in the patient's body.

Appendix 22: A pump assembly as described in any of Appendices 1-21, wherein the pump further comprises a wireless transceiver configured to receive operating instructions from a remote computing device and to provide information about the negative pressure therapy from the pump to the remote computing device.

Appendix 23: A pump assembly described in any of Appendices 1-22, wherein at least one ureteral catheter includes at least one axially deformable section configured to increase in length to accommodate patient movement.

Appendix 24: The pump assembly of Appendices 23, wherein the axially deformable compartment comprises at least one of an accordion compartment configuration on the sidewall of the at least one urinary catheter, a telescoping compartment on the at least one urinary catheter, or at least one axially extensible compartment.

Appendix 25: A pump assembly described in any of Appendices 1-24, wherein in the deployed configuration, the diameter of the retention portion exceeds the diameter of the discharge lumen.

Appendix 26: A system for increasing urine output from a patient, comprising: (a) a pump assembly according to any one of Appendices 1-25; and (b) a controller in wired or wireless communication with a pump of the pump assembly, the controller configured to direct operation of the pump and control the flow rate of fluid passing through a fluid conduit of the pump.

Appendix 27: The system of Appendix 26, further comprising a power supply for providing power to the pump and the controller, and a remote computing device in wired or wireless communication with the controller, the remote computing device configured to provide instructions to the controller for operating the pump and to receive information from the controller regarding at least one of a physiological condition of the pump or the patient.

Appendix 28: The system of Appendices 27, wherein the power supply comprises a battery positioned within the pump.

Appendix 29: The system described in Appendix 28, wherein the power supply includes an induction coil.

Appendix 30: The system of Appendices 29, wherein the information received from the controller comprises at least one of an indication that the battery is being recharged by the induction coil, an indication that the battery is fully charged, or an indication of the remaining charge in the battery.

Appendix 31: The system of any of Appendices 26-30, further comprising at least one fluid sensor in fluid communication with the drain lumen of the at least one ureteral catheter and/or with a fluid conduit within the pump, wherein the controller is configured to receive and process information from the at least one fluid sensor to determine at least one of a flow rate and a flow rate of the fluid through the drain lumen, compare the determined flow rate or flow rate to a target amount, and adjust the pump based on the comparison to increase or decrease at least one of the flow rate or flow rate through the drain lumen.

Appendix 32: The system of any of Appendices 26-31, further comprising at least one catheter probe sensor positioned on a retention portion of the at least one ureteral catheter, wherein the controller is configured to receive and process information from the at least one catheter probe sensor to determine a magnitude of negative pressure provided to the kidney and/or renal pelvis through the drainage lumen of the at least one ureteral catheter, compare the determined magnitude of negative pressure to a predetermined or target negative pressure value, and adjust the pump to increase the magnitude of the negative pressure when the determined magnitude is below the expected or target negative pressure value or decrease the magnitude of the negative pressure when the determined magnitude is above the expected or target negative pressure value.

Appendix 33: The system described in any of Appendices 26-32, further comprising at least one pressure sensor on an exterior surface of the pump housing configured to measure the patient's intra-abdominal pressure when the pump is at least partially implanted within the patient's abdominal cavity or peritoneum.

Appendix 34: The system of Appendices 33, wherein the controller is further configured to receive and process information from at least one pressure sensor to determine intra-abdominal pressure, compare the determined intra-abdominal pressure to a target intra-abdominal pressure value, and adjust the pump to increase the magnitude of negative pressure provided to the kidneys and/or renal pelvis when the determined intra-abdominal pressure exceeds the target value.

Appendix 35: The system of Appendix 34, wherein the controller is configured to continue providing increasing amounts of negative pressure to the kidneys and/or renal pelvis until the intra-abdominal pressure measured by the at least one pressure sensor decreases below a target intra-abdominal pressure value.

Appendix 36: A method for treating a patient by providing negative pressure therapy to a portion of the patient's urinary tract, the method comprising: positioning a pump of a pump assembly described in any of Appendices 1-25 in a deployed position within the patient's body; establishing fluid communication between the pump and an outlet lumen of at least one ureteral catheter; and activating the pump, thereby causing the pump to provide negative pressure to the patient's ureter, renal pelvis, and/or kidney through the outlet lumen of the at least one ureteral catheter.

Appendix 37: The method of Appendices 36, wherein the negative pressure delivered is in the range of 0 mmHg to about 150 mmHg, as measured at at least one fluid port of the pump.

Appendix 38: The method of Appendices 36 or 37, wherein the deployment position within the patient's body comprises a position within the patient's urinary tract.

Appendix 39: The method of Appendices 36 or 37, wherein the deployment location within the patient's body comprises a location within the patient's abdominal, peritoneal, or subcutaneous cavity outside the urinary tract.

Appendix 40: The method of Appendices 39, wherein the pump assembly further comprises an outflow catheter, the outflow catheter extending from the pump to the patient's bladder for conducting fluid from the pump to the bladder through a lumen of the outflow catheter, or extending from the pump to a location outside the patient's urinary tract for conducting fluid from the patient.

Appendix 41: The method of Appendices 40, further comprising advancing at least one ureteral catheter through the patient's urinary tract to the patient's kidney or renal pelvis, and deploying a retention portion of the at least one ureteral catheter within the kidney, ureter, and/or renal pelvis.

Appendix 42: The method of Appendices 41, further comprising positioning at least one ureteral catheter and at least one outflow catheter through at least one opening in the wall of the patient's bladder.

Appendix 43: The method of Appendices 42, wherein a portion of at least one ureteral catheter passing through at least one opening in the wall of the bladder is enclosed within the lumen of at least one outflow catheter.

Appendix 44: The method of Appendices 42, wherein a portion of at least one ureteral catheter and an outflow catheter passing through at least one opening in the bladder wall is enclosed within a tubular shunt.

Addendum 45: The method of any of Addendums 36-44, further comprising connecting the pump to a percutaneous shielded wire extending from the external controller to provide power and operating instructions to the pump from the controller.
The present invention provides, for example, the following.
(Item 1)
1. A pump assembly for increasing urine output from a patient, said assembly comprising:
(a) at least one ureteral catheter comprising: a distal portion comprising a retention portion configured to be positioned within a patient's kidney, renal pelvis, and/or ureter; and a proximal portion comprising a drainage lumen, the retention portion comprising at least one drainage port that permits fluid flow into the drainage lumen;
(b) a pump configured to provide negative pressure to at least one of the renal pelvis or kidney through an outlet lumen of the at least one ureteral catheter, the pump comprising at least one fluid port in fluid communication with the outlet lumen of the proximal portion of the ureteral catheter for receiving fluid from the patient's kidney, at least a portion of the pump configured to be positioned within the patient's body.
(Item 2)
2. The pump assembly of claim 1, wherein at least a portion of the pump is configured to be positioned within the patient's urinary tract.
(Item 3)
2. The pump assembly of claim 1, wherein at least a portion of the pump is configured to be implanted within the patient's body outside the urinary tract.
(Item 4)
The pump
a housing defining an opening for the at least one fluid port;
2. The pump assembly of claim 1, comprising: a pump chamber at least partially enclosed within the housing fluidly connected to the at least one fluid port, the pump configured to draw the fluid through the drainage lumen of the at least one ureteral catheter into the pump chamber, thereby exerting the negative pressure on at least a portion of an interior of the kidney and/or renal pelvis.
(Item 5)
2. The pump assembly of claim 1, wherein the at least one fluid port comprises an inflow port and an outflow port, and the pump assembly further comprises at least one outflow catheter in fluid communication with the outflow port, the outflow catheter configured to conduct the fluid received from the drainage lumen of the at least one ureteral catheter away from the pump.
(Item 6)
7. The pump assembly of claim 5, wherein the outflow catheter comprises a first end connected to the outflow port of the at least one fluid port of the pump, and a second end configured to be positioned within the patient's bladder to drain the fluid into the bladder or positioned outside the patient's urinary tract to drain urine from the patient.
6. The pump assembly of claim 5, wherein a portion of the at least one urinary catheter is positioned within a lumen of the at least one outflow catheter.
(Item 8)
8. The pump assembly of claim 7, wherein a portion of the at least one ureteral catheter positioned within the lumen of the at least one outflow catheter is configured to extend through an opening in the patient's bladder wall.
(Item 9)
6. The pump assembly of claim 5, further comprising a tubular shunt configured to extend through a bladder wall of the patient, wherein a portion of the at least one ureteral catheter and the at least one outflow catheter are positioned within a lumen of the tubular shunt.
(Item 10)
6. The pump assembly of claim 5, wherein the inflow port is configured to receive the first end of the at least one urinary catheter, and the outflow port extends at least partially around the inflow port.
(Item 11)
2. The pump assembly of claim 1, wherein the pump comprises at least one of a rotary pump, a rotational dynamic pump, or a positive displacement pump.
(Item 12)
2. The pump assembly of claim 1, wherein the retention portion of the at least one ureteral catheter comprises a periphery or protective surface area that, in response to application of negative pressure through the catheter, prevents mucosal tissue from occluding one or more protected drainage holes, ports, or perforations located within the periphery or protective surface area.
(Item 13)
Item 13. The pump assembly of item 12, wherein the retention portion comprises a coil, and the one or more protected drain holes, ports, or perforations extend through a radially inward-facing portion of a sidewall of the coil.
(Item 14)
2. The pump assembly of claim 1, wherein the pump is configured to provide a negative pressure ranging from 0 mmHg to about 150 mmHg to the drainage lumen of the at least one urinary catheter, as measured at the at least one fluid port of the pump.
(Item 15)
2. The pump assembly of claim 1, wherein the pump is configured to generate sufficient negative pressure within the ureter, renal pelvis, and/or kidney to establish a pressure gradient across a glomerulus of the patient's kidney and promote urine flow toward the drainage lumen of the at least one ureteral catheter.
(Item 16)
Item 10. The pump assembly of item 1, wherein the pump includes a battery.
(Item 17)
17. The pump assembly of claim 16, wherein the pump further comprises an induction coil electronically coupled to the battery for providing power to the pump and for recharging the battery.
(Item 18)
18. The pump assembly of claim 17, wherein the induction coil is configured to generate electrical power when exposed to an electromagnetic field generated by a remote device positioned outside or within the patient's body.
(Item 19)
20. The pump assembly of claim 17, wherein the induction coil comprises a conductive wire disposed at least partially on a flexible sheet.
(Item 20)
10. The pump assembly of claim 1, further comprising an external controller positioned outside the patient's body, the external controller electrically coupled to the pump and providing power to the pump.
(Item 21)
21. The pump assembly of claim 20, further comprising at least one electrical cable extending between the external controller and the pump through at least one percutaneous access opening in the patient's body.
(Item 22)
2. The pump assembly of claim 1, wherein the pump further comprises a wireless transceiver configured to receive operating instructions from a remote computing device and to provide information about the negative pressure therapy from the pump to the remote computing device.
(Item 23)
2. The pump assembly of claim 1, wherein the at least one urinary catheter comprises at least one axially deformable section configured to increase in length to accommodate patient movement.
(Item 24)
24. The pump assembly of claim 23, wherein the axially deformable compartment comprises at least one of an accordion compartment configuration on a sidewall of the at least one urinary catheter, an elastic compartment of the at least one urinary catheter, or at least one axially extensible compartment.
(Item 25)
2. The pump assembly of claim 1, wherein in the deployed configuration, the diameter of the retention portion exceeds the diameter of the exhaust lumen.
(Item 26)
1. A system for increasing urine output from a patient, comprising:
(a) the pump assembly of item 1;
(b) a controller in wired or wireless communication with the pump of the pump assembly;
The system, wherein the controller is configured to direct operation of the pump and control a flow rate of fluid passing through a fluid conduit of the pump.
(Item 27)
a power supply for providing electrical power to the pump and the controller;
27. The system of claim 26, further comprising: a remote computing device in wired or wireless communication with the controller, the remote computing device configured to provide instructions to the controller for operating the pump and to receive information from the controller regarding at least one of the pump or a physiological condition of the patient.
(Item 28)
28. The system of claim 27, wherein the power supply comprises a battery located within the pump.
(Item 29)
30. The system of claim 28, wherein the power supply comprises an induction coil.
(Item 30)
30. The system of claim 29, wherein the information received from the controller comprises at least one of an indication that the battery is being recharged by the induction coil, an indication that the battery is fully charged, or an indication of the remaining charge of the battery.
(Item 31)
and at least one fluid sensor in fluid communication with the drain lumen of the at least one urinary catheter and/or with a fluid conduit within the pump, wherein the controller:
receiving and processing information from the at least one fluid sensor to determine at least one of a flow rate and a flow rate of the fluid through the drain lumen;
comparing the determined flow rate or flow rate to a target amount;
and adjusting the pump based on the comparison to increase or decrease at least one of a flow rate or a flow rate through the exhaust lumen.
(Item 32)
and at least one catheter probe sensor positioned on the retention portion of the at least one ureteral catheter, the controller further comprising:
receiving and processing information from the at least one catheter probe sensor to determine a magnitude of negative pressure provided to the kidney and/or renal pelvis through the drainage lumen of the at least one ureteral catheter;
comparing the determined magnitude of the negative pressure to a predetermined or target negative pressure value;
27. The system of claim 26, configured to adjust the pump to increase the magnitude of the negative pressure when the determined magnitude is below an expected or target negative pressure value, or to decrease the magnitude of the negative pressure when the determined magnitude is above the expected or target negative pressure value.
(Item 33)
27. The system of claim 26, further comprising at least one pressure sensor on an exterior surface of the pump housing configured to measure intra-abdominal pressure of the patient when the pump is at least partially implanted within the patient's abdominal cavity or peritoneum.
(Item 34)
The controller further comprises:
receiving and processing information from the at least one pressure sensor to determine the intra-abdominal pressure;
comparing the determined intra-abdominal pressure to a target intra-abdominal pressure value;
and adjusting the pump to increase the magnitude of the negative pressure provided to the kidney and/or renal pelvis when the determined intra-abdominal pressure exceeds the target value.
(Item 35)
35. The system of claim 34, wherein the controller is configured to continue providing the increased magnitude of negative pressure to the kidney and/or renal pelvis until the intra-abdominal pressure measured by the at least one pressure sensor decreases below the target intra-abdominal pressure value.
(Item 36)
1. A method for treating a patient by providing negative pressure therapy to a portion of the patient's urinary tract, the method comprising:
positioning a pump of the pump assembly of claim 1 in a deployed position within the patient's body;
establishing fluid communication between the pump and the drainage lumen of the at least one urinary catheter;
activating the pump, thereby causing the pump to provide negative pressure to the patient's ureter, renal pelvis, and/or kidney through the drainage lumen of the at least one urinary catheter.
(Item 37)
37. The method of claim 36, wherein the negative pressure is delivered in the range of 0 mmHg to about 150 mmHg as measured at the at least one fluid port of the pump.
(Item 38)
37. The method of claim 36, wherein the deployment location within the patient's body comprises a location within the patient's urinary tract.
(Item 39)
37. The method of claim 36, wherein the deployment location within the patient's body comprises a location within the patient's abdominal, peritoneal, or subcutaneous cavity outside the urinary tract.
(Item 40)
40. The method of claim 39, wherein the pump assembly further comprises an outflow catheter, the outflow catheter extending from the pump to the patient's bladder for conducting the fluid from the pump to the bladder through a lumen of the outflow catheter, or extending from the pump to a location outside the patient's urinary tract for conducting the fluid from the patient.
(Item 41)
41. The method of claim 40, further comprising advancing the at least one ureteral catheter through the patient's urinary tract to the patient's kidney or renal pelvis, and deploying the retention portion of the at least one ureteral catheter within the kidney, ureter, and/or renal pelvis.
(Item 42)
42. The method of claim 41, further comprising positioning the at least one ureteral catheter and the at least one outflow catheter through at least one opening in the wall of the patient's bladder.
(Item 43)
43. The method of claim 42, wherein a portion of the at least one ureteral catheter that passes through the at least one opening in the wall of the bladder is enclosed within a lumen of the at least one outflow catheter.
(Item 44)
43. The method of claim 42, wherein the portion of the at least one ureteral catheter and the outflow catheter that passes through the at least one opening in the bladder wall is enclosed within a tubular shunt.
(Item 45)
37. The method of claim 36, further comprising connecting the pump to a percutaneous shielded wire extending from an external controller to provide power and operating instructions to the pump from the controller.

These and other features and characteristics of the present disclosure, as well as the method of operation, use, and function of the associated elements of structure, and combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and appended claims, with reference to the accompanying drawings, all of which form a part of this specification and in which like reference numerals designate corresponding parts in the various views. It is to be expressly understood, however, that the drawings are for purposes of illustration and description only and are not intended as a definition of the limits of the invention.

Further features and other embodiments and advantages will become apparent from the following detailed description, considered in conjunction with the drawings.

FIG. 1A is a schematic diagram of a patient's urinary tract showing a pump assembly positioned within the patient's ureter and bladder, according to an embodiment of the present disclosure.

FIG. 1B is an enlargement of a portion of FIG. 1A.

FIG. 1C is a schematic diagram of a patient's urinary tract showing a pump assembly positioned within the patient's renal pelvis and ureter, according to another embodiment of the present disclosure.

FIG. 1D is a schematic diagram of a patient's urinary tract showing a pump assembly positioned within the patient's bladder, according to another embodiment of the present disclosure.

2A and 2B are schematic diagrams of a pump assembly according to an embodiment of the present disclosure.

FIG. 3 is a schematic diagram of a pump assembly with a wire linkage between the pump and its controller, according to an embodiment of the present disclosure.

FIG. 4 is a schematic diagram of a pump assembly including anchor barbs extending radially outward from its sidewall, according to an embodiment of the present disclosure.

FIG. 5 is a schematic diagram of a pump assembly with a helical retention barb according to an embodiment of the present disclosure.

FIG. 6 is a schematic illustration of a pump assembly including an inlet conduit configured to be inserted into a patient's ureter, according to an embodiment of the present disclosure.

FIG. 7 is a cross-sectional view of a portion of the pump assembly of FIGS. 2A and 2B taken along line 7-7.

FIG. 8 is a cross-sectional view of a portion of a pump assembly according to an embodiment of the present disclosure.

FIG. 9 is a schematic diagram of a pump assembly with a deployable induction coil according to an embodiment of the present disclosure.

10 is a schematic illustration of the pump assembly of FIG. 9 deployed within a patient's urinary tract, according to an embodiment of the present disclosure.

FIG. 11 is a schematic diagram of the electronic components of the pump assembly of FIGS. 2A and 2B.

FIG. 12 is a schematic diagram of a system for inducing negative pressure within a patient's urinary tract, including a pump assembly, according to an embodiment of the present disclosure.

FIG. 13A is a schematic illustration of a delivery catheter for delivery of a pump assembly into a portion of a patient's urinary tract, according to an embodiment of the present disclosure.

FIG. 13B is a schematic diagram of the delivery catheter of FIG. 13A with a portion of the extension tube cut away to show the pump assembly contained therein.

FIG. 14 is a schematic diagram of a pump assembly including a pump positioned within a patient's bladder, according to an embodiment of the present disclosure.

FIG. 15A is a schematic diagram of an embodiment of an implantable pump system implanted within a patient's abdomen and urinary tract, according to an embodiment of the present disclosure.

FIG. 15B is a perspective view of the components of the pump system of FIG. 15A.

FIG. 15C is another perspective view of the pump system of FIG. 15A showing the components inside the pump housing.

FIG. 15D is a schematic diagram of the electrical components of the pump system of FIG. 15A.

FIG. 16A is a schematic diagram of another embodiment of an implantable pump system that is implanted within a patient's abdomen and urinary tract.

FIG. 16B is a perspective view of the components of the implantable pump system of FIG. 16A.

FIG. 16C is a schematic diagram of the electrical components of the pump system of FIG. 16A.

17A and 17B are schematic diagrams showing examples of pump fluid conduits extending between pump chambers or elements and the pump's fluid ports.

18A-18D are schematic diagrams of examples of catheter tubing that may be used with the implantable pump systems disclosed herein.

19A and 19B are schematic diagrams illustrating a technique for suturing a catheter to the bladder wall for use with an implantable pump system, according to an embodiment of the present disclosure.

FIG. 20 is a flow diagram illustrating an exemplary method for implanting components of an implantable pump system.

FIG. 21A is a schematic diagram showing a bypass catheter implanted within a patient's renal pelvis and/or kidney.

FIG. 21B is a schematic diagram of an implantable pump system including the bypass catheter of FIG. 21A according to an embodiment of the present disclosure.

FIG. 22A is a schematic illustration of an embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

FIG. 22B is a schematic illustration of another embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

FIG. 22C is a schematic illustration of another embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

FIG. 22D is a schematic illustration of another embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

FIG. 22E is a schematic illustration of another embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

Figure 22F is an enlarged schematic view of a portion of a ureteral catheter according to the present invention positioned within the renal pelvis region of a kidney, showing in phantom the general changes that are believed to occur within the renal pelvis tissue in response to the application of negative pressure through the ureteral catheter.

FIG. 23A is a perspective view of a retention portion of a ureteral catheter, according to an embodiment of the present invention.

23B is a front view of the retention portion of FIG. 23A in accordance with an embodiment of the present invention.

23C is a rear view of the retention portion of FIG. 23A in accordance with an embodiment of the present invention.

23D is a top view of the retention portion of FIG. 23A in accordance with an embodiment of the present invention.

FIG. 23E is a cross-sectional view of the retention portion of FIG. 23A taken along line 10E-10E, in accordance with an embodiment of the present invention.

Figure 23F is a cross-sectional view of the retention portion of Figure 23A taken along line 23E-23E according to an embodiment of the present invention positioned within the renal pelvis region of the kidney, generally illustrating the changes that are believed to occur within the renal pelvis tissue in response to the application of negative pressure through a ureteral catheter.

FIG. 24 is a schematic illustration of a retaining portion of a catheter in a constrained or linear position, according to an embodiment of the present invention.

FIG. 25 is a schematic illustration of another embodiment of a retaining portion of a catheter in a restrained or linear position, in accordance with an embodiment of the present invention.

FIG. 26 is a schematic illustration of another embodiment of a retention portion of a ureteral catheter in a constrained or linear position, in accordance with an embodiment of the present invention.

FIG. 27 is a schematic illustration of another embodiment of a retaining portion of a catheter in a restrained or linear position, in accordance with an embodiment of the present invention.

FIG. 28A is a side elevational view of a retaining portion of a catheter, in accordance with an embodiment of the present invention.

28B is a cross-sectional view of the retention portion of the catheter of FIG. 28A taken along line BB of FIG. 28A.

28C is a top plan view of the retention portion of the catheter of FIG. 28A taken along line CC of FIG. 28A.

Figure 28D is a cross-sectional view of a retention portion of a ureteral catheter according to an embodiment of the present invention positioned within the renal pelvis region of a kidney, generally illustrating the changes that are believed to occur within the renal pelvis tissue in response to the application of negative pressure through the ureteral catheter.

FIG. 29 is a side elevational view of another catheter retention portion, in accordance with an embodiment of the present invention.

FIG. 30 is a side elevational view of another catheter retention portion, in accordance with an embodiment of the present invention.

FIG. 31A is a perspective view of another ureteral catheter retention portion in accordance with an embodiment of the present invention.

FIG. 31B is a top plan view of the retention portion of the catheter of FIG. 31A taken along line 31B-31B of FIG. 31A.

FIG. 32A is a perspective view of another catheter retention portion, in accordance with an embodiment of the present invention.

32B is a top plan view of the retention portion of the catheter of FIG. 32A taken along line 32B-B of FIG. 32A.

FIG. 33A is a perspective view of another catheter retention portion, in accordance with an embodiment of the present invention.

Figure 33B is a cross-sectional view of a retention portion of a ureteral catheter according to an embodiment of the present invention positioned within the renal pelvis region of a kidney, generally illustrating the changes that are believed to occur within the renal pelvis tissue in response to the application of negative pressure through the ureteral catheter.

FIG. 34 is a side elevational view of another catheter retention portion, in accordance with an embodiment of the present invention.

FIG. 35 is a side elevational view of another catheter retention portion, in accordance with an embodiment of the present invention.

FIG. 36 is a cross-sectional side view of a retention portion of another catheter, in accordance with an embodiment of the present invention.

FIG. 37A is a perspective view of another catheter retention portion, in accordance with an embodiment of the present invention.

FIG. 37B is a top plan view of the retention portion of the catheter of FIG. 37A.

FIG. 38A is a perspective view of another catheter retention portion, in accordance with an embodiment of the present invention.

FIG. 38B is a top plan view of the retention portion of the catheter of FIG. 38A.

Figure 38C is a cross-sectional view of a retention portion of a ureteral catheter according to an embodiment of the present invention positioned within the renal pelvis region of a kidney, generally illustrating the changes that are believed to occur within the renal pelvis tissue in response to the application of negative pressure through the ureteral catheter.

FIG. 39 is a perspective view of another catheter retention portion, in accordance with an embodiment of the present invention.

40 is a top plan view of the retention portion of the catheter of FIG. 39. FIG.

FIG. 41A is a perspective view of another catheter retention portion, in accordance with an embodiment of the present invention.

FIG. 41B is a top plan view of the retention portion of the catheter of FIG. 41A.

FIG. 42 is a cross-sectional side elevation view of another catheter retention portion, in accordance with an embodiment of the present invention.

FIG. 43 is a cross-sectional side elevation view of a retention portion of another catheter, in accordance with an embodiment of the present invention.

FIG. 44A is a perspective view of another catheter retention portion, in accordance with an embodiment of the present invention.

44B is a cross-sectional side elevation view of the retention portion of the catheter of FIG. 44A taken along line BB of FIG. 44A.

FIG. 45 is a side elevational view showing a cutaway cross section of a sheath surrounding a catheter in accordance with an embodiment of the present invention in a collapsed configuration for insertion into a patient's ureter.

FIG. 46A is a schematic illustration of another embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

FIG. 46B is a schematic illustration of a cross-sectional view of a portion of the retention portion of FIG. 46A taken along line BB of FIG. 46A.

FIG. 47A is a schematic illustration of another embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

FIG. 47B is a schematic illustration of a cross-sectional view of a portion of the retention portion of FIG. 47A taken along line BB of FIG. 47A.

FIG. 48A is a schematic illustration of another embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

Figure 48B is a schematic diagram of a cross-sectional view of another embodiment of a retention portion for a ureteral catheter according to an embodiment of the present invention positioned within the renal pelvis region of a kidney, generally illustrating the changes that are believed to occur within the renal pelvis tissue in response to the application of negative pressure through the ureteral catheter.

FIG. 49A is a schematic illustration of a cross-sectional view of another embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

Figure 49B is a schematic diagram of a cross-sectional view of another embodiment of a retention portion for a ureteral catheter according to an embodiment of the present invention positioned within the renal pelvis region of a kidney, generally illustrating the changes that are believed to occur within the renal pelvis tissue in response to the application of negative pressure through the ureteral catheter.

FIG. 50A is a schematic illustration of another embodiment of a retention portion for a catheter, in accordance with an embodiment of the present invention.

Figure 50B is a schematic diagram of a cross-sectional view of another embodiment of a retention portion for a ureteral catheter according to an embodiment of the present invention positioned within the renal pelvis region of a kidney, generally illustrating the changes that are believed to occur within the renal pelvis tissue in response to the application of negative pressure through the ureteral catheter.

FIG. 51 is a cross-sectional view of a portion of a ureteral catheter in a linear, uncoiled state, including a multi-functional coating, according to an embodiment of the present disclosure.

FIG. 52 is a cross-sectional view of a portion of the ureteral catheter of FIG. 51 in a deployed or coiled state.

FIG. 53 is a cross-sectional view of a portion of a ureteral catheter in a linear, uncoiled state, including another exemplary multi-functional coating, according to an embodiment of the present disclosure.

FIG. 54 is a cross-sectional view of a portion of a ureteral catheter in a linear, uncoiled state, including another exemplary multi-functional coating, according to an embodiment of the present disclosure.

FIG. 55 is a cross-sectional view of an embodiment of a catheter configured to be inserted into the renal pelvis through a percutaneous access site according to an embodiment of the present disclosure.

FIG. 56A is a perspective view of another embodiment of a catheter configured to be inserted into the renal pelvis through a percutaneous access site.

FIG. 56B is a cross-sectional view of the catheter of FIG. 56A.

Detailed Description
As used herein, the singular forms "a,""an," and "the" include plural references unless the context clearly dictates otherwise.

As used herein, the terms "right," "left," "upper," and derivatives thereof, shall refer to the present invention as oriented in the drawings. The term "proximal" refers to the portion of the catheter device that is manipulated or contacted by a user and/or a portion of an indwelling catheter nearest a urinary access site, e.g., a urethral or percutaneous access opening within a patient's body. The term "distal" refers to the opposite end of the catheter device configured for insertion into a patient and/or the portion of the device inserted most distally in the patient's urinary tract. However, it should be understood that the present invention is capable of various alternative orientations, and therefore, such terms are not intended to be limiting. It should also be understood that the present invention is capable of various alternative modifications and step sequences, unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are examples. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not intended to be limiting.

For purposes of this specification, unless otherwise indicated, all numbers expressing quantities of ingredients, reaction conditions, dimensions, physical properties, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about." Unless indicated to the contrary, the numerical parameters set forth in the following specification and appended claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention.

Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. However, any measured numerical value can inherently contain certain errors resulting from the standard deviation found in their respective testing measurements.

It should also be understood that any numerical range recited herein is intended to include all subranges subsumed therein. For example, a range of "1 to 10" is intended to include the recited minimum value of 1 and the recited maximum value of 10, including all subranges therebetween, i.e., all subranges starting with a minimum value equal to or greater than 1 and ending with a maximum value equal to or less than 10, and all subranges therebetween, for example, 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1.

As used herein, the terms "communication" and "communicating" refer to the receipt or transfer of one or more signals, messages, commands, or other types of data. For one unit or component to communicate with another unit or component means that the unit or component can receive data from and/or transmit data to the other unit or component, directly or indirectly. This may refer to a direct or indirect connection, which may be wired and/or wireless in nature. Additionally, two units or components may communicate with each other even if the transmitted data is modified, processed, routed, and the like, between the first and second units or components. For example, a first unit may communicate with a second unit even if the first unit passively receives data and does not actively transmit data to the second unit. As another example, a first unit may communicate with a second unit if an intermediate unit processes data from one unit and transmits the processed data to the second unit. It should be understood that numerous other arrangements are possible.

As used herein, "maintaining patency of fluid flow between a patient's kidney and bladder" means establishing, increasing, or maintaining the flow of fluid, such as urine, from the kidney through the ureter, ureteral stent, and/or ureteral catheter to the bladder and outside the body.
In some examples, fluid flow is promoted or maintained by providing a protective surface area 1001 within the upper urinary tract and/or bladder, preventing the urinary tract endothelium from contracting or collapsing into the fluid column or flow. As used herein, "fluid" refers to urine and any other fluid from the urinary tract.

As used herein, "negative pressure" means that the pressure applied to the proximal end of the bladder catheter or the proximal end of the ureteral catheter, respectively, is less than the pre-existing pressure at the proximal end of the bladder catheter or the proximal end of the ureteral catheter, respectively, prior to application of the negative pressure; e.g., a pressure difference exists between the proximal end of the bladder catheter or the proximal end of the ureteral catheter, respectively, and the pre-existing pressure at the proximal end of the bladder catheter or the proximal end of the ureteral catheter, respectively, prior to application of the negative pressure. This pressure difference causes fluid from the kidney to be drawn into the ureteral catheter or the bladder catheter, respectively, or through both the ureteral and bladder catheters, and then outside the patient's body. For example, the negative pressure applied to the proximal end of the bladder catheter or the proximal end of the ureteral catheter can be less than atmospheric pressure (less than about 760 mmHg or about 1 atmosphere) or less than the pressure measured at the proximal end of the bladder catheter or the proximal end of the ureteral catheter prior to application of the negative pressure, so that fluid is drawn from the kidney and/or bladder. In some examples, the negative pressure applied to the proximal end of the bladder catheter or the proximal end of the ureteral catheter can range from about 0.1 mmHg to about 150 mmHg, or from about 0.1 mmHg to about 50 mmHg, or from about 0.1 mmHg to about 10 mmHg, or from about 5 mmHg to about 20 mmHg, or about 45 mmHg (gauge pressure at the pump 710 or gauge at the negative pressure source). In some embodiments, the negative pressure source comprises a pump external to the patient's body for application of negative pressure through both the bladder catheter and the ureteral catheter, which in turn draws fluid from the kidney into the ureteral catheter, through both the ureteral catheter and the bladder catheter, and then outside the patient's body. In some embodiments, the negative pressure source comprises a vacuum source external to the patient's body for application and adjustment of negative pressure through both the bladder catheter and the ureteral catheter, which in turn draws fluid from the kidney into the ureteral catheter, through both the ureteral catheter and the bladder catheter, and then outside the patient's body. In some embodiments, the vacuum source is selected from the group consisting of a wall suction source, a vacuum bottle, and a manual vacuum source, or the vacuum source is provided by a pressure differential. In some embodiments, the negative pressure received from the negative pressure source can be controlled manually, automatically, or a combination thereof. In some embodiments, a controller is used to adjust the negative pressure from the negative pressure source. Non-limiting examples of negative and positive pressure sources are discussed in detail below. Systems for providing negative pressure therapy are also disclosed in International Publication No. WO 2017/015351, entitled "Ureteral and Bladder Catheters and Methods for Inducing Negative Pressure to Increase Renal Perfusion," and International Publication No. WO 2017/015345, entitled "Catheter Device and Method for Inducing Negative Pressure in a Patient's Bladder," each of which is incorporated herein by reference in its entirety.

Fluid retention and venous stasis are major problems in the progression of progressive renal disease. Excessive sodium intake coupled with a relative decrease in excretion leads to isotonic volume expansion and the complications of secondary compartment syndrome. In some embodiments, the present invention is generally directed to devices and methods for facilitating the evacuation of urine or waste products from a patient's bladder, ureters, and/or kidneys. In some embodiments, the present invention is generally directed to systems and methods for inducing negative pressure within a patient's bladder, ureters, and/or kidneys, e.g., at least a portion of the urinary system. While not intending to be bound by any theory, it is believed that applying negative pressure to the bladder, ureters, and/or kidneys, e.g., at least a portion of the urinary system, can compensate for medullary renal unit tubular reabsorption of sodium and water in some circumstances. Compensating for sodium and water reabsorption can increase urine production, reduce total body sodium, and improve red blood cell production. Because intramedullary pressure is driven by sodium and therefore volume excess, targeted removal of excess sodium allows volume loss to be maintained. Volume removal reverses medullary congestion. Normal urine production is 1.48-1.96 L/day (or 1-1.4 ml/min).

Fluid retention and venous congestion are also major problems in the progression of prerenal acute kidney injury (AKI). Specifically, AKI can be associated with loss of perfusion or blood flow through the kidney. Thus, in some embodiments, the present invention promotes improved renal hemodynamics and increases urine output for the purpose of alleviating or reducing venous congestion. Furthermore, treating and/or preventing AKI is expected to favorably affect and/or reduce the occurrence of other symptoms, such as reducing or preventing the deterioration of renal function in patients with NYHA Class III and/or Class IV heart failure. Classification of different levels of heart failure is described in The Criteria Committee of the New York Heart Association, (1994), Nomenclature
and Criteria for Diagnosis of Diseases of the Heart and Great Vessels, (9th ed.), Boston: Little, Brown and Co. pp. 253-256, the disclosure of which is incorporated herein by reference in its entirety. Reducing or preventing episodes of AKI and/or chronic hypoperfusion may also be a treatment for stage 4 and/or stage 5 chronic kidney disease. The progression of chronic kidney disease is explained in the National Kidney Foundation, K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and Stratification. Am. J. Kidney Dis. 39:S1-S266, 2002 (Suppl. 1), the disclosure of which is incorporated herein by reference in its entirety.

The ureteral catheters, ureteral stents, and/or bladder catheters disclosed herein may also be useful for preventing, delaying the onset of, and/or treating end-stage renal disease ("ESRD"). The average dialysis patient consumes approximately $90,000 per year in healthcare utilization for a total cost to the U.S. government of $33.9 billion. Currently, ESRD patients comprise only 2.9% of all Medicare beneficiaries but account for over 13% of total expenditures. While incidence and per-patient costs have stabilized in recent years, active patient volume continues to rise.

Five stages of progressive chronic kidney disease ("CKD") are based on glomerular filtration rate (GFR). Stage 1 (GFR>90) patients have normal filtration, while stage 5 (GFR<15) has renal failure. As with many chronic diseases, diagnostic coverage improves with increasing symptoms and disease severity.

The CKD 3b/4 subgroup is a smaller subgroup that reflects important changes in disease progression, healthcare system involvement, and transition to ESRD. Emergency department visits increase with CKD severity. Among the U.S. Veterans Affairs population, nearly 86% of incident dialysis patients were hospitalized within the 5 years preceding hospitalization. Of those, 63% were hospitalized at the initiation of dialysis. This suggests a significant opportunity for intervention prior to dialysis.

Despite being further down the arterial tree than other organs, the kidneys receive a disproportionate amount of cardiac output at rest. The glomerular membrane represents the path of least resistance for filtrate into the renal tubule. In health, the nephrocyte has multiple, complex, and redundant means of self-regulating arterial pressure within the normal range.

Venous congestion contributes to reduced renal function and is associated with the systemic hypervolemia found in late-stage CKD. Because the kidneys are covered by a semi-rigid capsule, small changes in venous pressure are translated into direct changes in intratubular pressure. This shift in intratubular pressure has been shown to upregulate sodium and water reabsorption, perpetuating a vicious cycle.

Regardless of initial insult and early progression, more progressive CKD is associated with decreased filtration (by definition) and further azotemia. Whether the remaining renal units are overabsorbing fluid or simply unable to filter adequately, this loss of renal units is associated with fluid retention and progressive decline in renal function.

The kidneys are sensitive to subtle shifts in volume. As pressure increases in either the tubule or capillary bed, pressure in the other follows. As capillary bed pressure increases, filtrate production and urine excretion can decrease dramatically. While not intending to be bound by any theory, it is believed that a slight, regulated negative pressure delivered to the renal pelvis reduces pressure between each functioning renal unit. In healthy anatomy, the renal pelvis is connected to approximately one million individual renal units via the calyces and collecting duct network. Each of these renal units is essentially a fluid column connecting Bowman's space to the renal pelvis. Pressure transmitted to the renal pelvis translates throughout. As negative pressure is applied to the renal pelvis, glomerular capillary pressure is thought to force more filtrate across the glomerular membrane, leading to increased urine output.

It is important to note that the tissues of the urinary tract are lined with urothelium, a type of transitional epithelium. The inner tissue lining of the urinary tract is also referred to as urinary tract endothelium or urothelial tissue, such as the mucosal tissue 1003 of the ureter and/or kidney and bladder tissue 1004. The urothelium has very high elasticity, allowing for a remarkable range of collapsibility and extensibility. The urothelium lining the ureter lumen is first surrounded by the lamina propria, a thin layer of loose connective tissue, which together comprise the urothelial mucosa. This mucosa is then surrounded by a layer of longitudinal muscle fibers. These longitudinal muscle fibers surrounding the urothelial mucosa and the elasticity of the urothelial mucosa itself allow the ureter to relax into a collapsed stellate cross-section and then expand to full distention during diuresis. The histology of any normal ureter cross-section generally reveals this star-shaped lumen in humans and other mammals used in translational medical research. Wolf et al. , “Comparative Ureteral Microanatomy”, JEU 10:527-31 (1996).

The process of transporting urine from the kidney to the bladder is driven by contractions through the renal pelvis and peristalsis through the remainder of the ureter distally. The renal pelvis is the funnel-shaped enlargement of the proximal ureter where the ureter enters the kidney. The renal pelvis has been shown to be a continuation of the ureter, composed of the same tissue but with an additional muscle layer that allows it to contract. Dixon and Gosling, "The Musculature of the Human Renal Calyces, Pelvis, and Upper Ureter," J. Anat. 135:129-37 (1982). These contractions push urine through the renal pelvis funnel, allowing peristaltic waves to propagate fluid through the ureter to the bladder.

Imaging studies have shown that the dog ureter can easily increase its resting cross-sectional area by up to 17 times, allowing it to accommodate large volumes of urine during diuresis. Woodburne and Lapides, "The Ureteral Lumen During Peristalsis," AJA 133:255-8 (1972). Even in the pig, considered the closest animal model for the human upper urinary tract, the renal pelvis and proximal-most ureter have been shown to be, in fact, the most flexible of all ureteral segments. Gregersen, et al., "Regional Differences Exist in Elastic Wall Properties in the Ureter," SJUN 30:343-8 (1996). Wolf's comparative studies of human ureteral microanatomy with that of various research animals revealed comparable thickness of the lamina propria to total ureteral diameter in dogs (29.5% in humans and 34% in dogs) and comparable proportions of smooth muscle to total muscle cross-sectional area in pigs (54% in humans and 45% in pigs). While limitations in interspecies comparisons certainly exist, dogs and pigs have historically been a strong focus in studying and understanding human ureteral anatomy and physiology, and these reference values support this high level of translatability.

There is far more data available on the structure and mechanics of the porcine and canine ureter and renal pelvis than on the human ureter. This is due, in part, to the invasiveness required for such detailed analysis and the inherent limitations of various imaging modalities (MRI, CT, ultrasound, etc.) for clinically and accurately identifying the size and composition of such small, flexible, dynamic structures. Nevertheless, the ability of the renal pelvis to distend or completely collapse in humans presents an obstacle for nephrologists and urologists seeking to improve urinary flow.

While not intending to be bound by any theory, the inventors theorize that application of negative pressure may help promote fluid flow from the kidney, and that a very specific tool designed to deploy a protective surface area to open or maintain the interior of the renal pelvis while preventing surrounding tissue from contracting or collapsing into a fluid column under negative pressure is required to facilitate the application of negative pressure within the renal pelvis. The inventive catheter design disclosed herein provides a protective surface area to prevent surrounding urothelial tissue from contracting or collapsing into a fluid column under negative pressure. It is believed that the inventive catheter design disclosed herein may maintain the normal stellate longitudinal folding of the ureteral wall away from the central axis of the catheter outlet lumen and the protected holes, preventing natural sliding and/or downward movement of the catheter along the stellate cross-sectional area of the ureteral lumen due to peristaltic waves.

The inventive catheter design disclosed herein also avoids an unprotected open hole at the distal end of the drainage lumen that fails to protect surrounding tissue during aspiration. While it is convenient to think of the ureter as a straight tube, the true ureter and renal pelvis may enter the kidney at various angles. Lippincott Williams & Wilkins, Annals of Surgery, 58, Figs. 3 & 9 (1913). Therefore, it would be difficult to control the orientation of the unprotected open hole at the distal end of the drainage lumen when deploying such a catheter within the renal pelvis. This single hole does not have a means of ensuring any reliable or consistent distance from the tissue wall, thereby presenting a localized aspiration point that could allow tissue to occlude the unprotected open hole and risk tissue damage. Additionally, the inventive catheter designs disclosed herein avoid placement of balloons with unprotected, open holes at the distal end of the draining lumen near the kidney, which can result in suction against and/or obstruction of the calyces. Placement of balloons with unprotected, open holes at the distal end of the draining lumen at the base of the ureteropelvic junction can result in suction against and obstruction by renal pelvic tissue. Also, rounded balloons can present a risk of ureteral avulsion or other injury from incidental traction on the balloon.

Delivering negative pressure into a patient's renal area poses several anatomical challenges for at least three reasons. First, the urinary system is composed of highly flexible tissue that is easily deformed. Medical textbooks often depict the bladder as a thick, muscular structure that can remain in a fixed shape regardless of the volume of urine contained therein. However, in reality, the bladder is a soft, deformable structure. It contracts and conforms to the volume of urine contained therein. An empty bladder resembles a deflated latex balloon more than a ball. Additionally, the mucosal lining inside the bladder is soft and prone to inflammation and injury. It is desirable to avoid drawing urinary system tissue into the catheter orifice, maintaining adequate fluid flow therethrough and avoiding injury to surrounding tissue.

Second, the ureter is a small tubular structure that can expand and contract to transport urine from the renal pelvis to the bladder. This transport occurs in two ways: peristaltic activity and pressure gradients within an open system. In peristaltic activity, urine portions are pushed ahead by contractile waves that nearly completely occlude the lumen. The wave pattern begins within the renal pelvic area, propagates along the ureter, and terminates at the bladder. Such complete obstruction disrupts fluid flow and may prevent negative pressure delivered within the bladder from reaching the renal pelvis unassisted. A second type of transport, due to a pressure gradient through the wide-open ureter, may exist during large-volume urine flow. During such cycles of large-volume urine production, the pressure head within the renal pelvis would not necessarily be caused by contraction of smooth muscle in the upper urinary tract, but rather by the forward flow of urine and thus reflects arterial blood pressure. Kiil F. , “Urinary Flow and Ureteral Peristalsis” in: Lutzeyer W. , Melchior H. (eds) Urodynamics. Springer, Berlin, Heidelberg (pp. 57-70) (1973).

Third, the renal pelvis is at least as flexible as the bladder. Its thin walls allow it to expand and accommodate multiple times its normal volume, as occurs, for example, in patients with hydronephrosis.

More recently, the use of negative pressure within the renal pelvis to remove blood clots from the renal pelvis by using suction has been cautioned against due to the inevitable collapse of the renal pelvis, thus preventing the use of negative pressure within the renal pelvic region. Webb, Percutaneous Renal Surgery: A Practical Clinical Handbook. p. 92. Springer (2016).

While not intending to be bound by any theory, the renal pelvis and bladder tissues are flexible enough to be drawn inward during delivery of negative pressure, conforming to the shape and volume of the tool being used to deliver the negative pressure. Similar to the vacuum seal of a husked ear of corn, the urothelial tissue will collapse around and conform to the negative pressure source. To prevent the tissue from obstructing the lumen and impeding urine flow, the inventors theorize that sufficient protective surface area to maintain a fluid column when a mild negative pressure is applied will prevent or discourage obstruction.

The inventors have determined that specific features exist that allow catheter tools to be successfully deployed in and deliver negative pressure through urinary regions not previously described. These require a deep understanding of the anatomy and physiology of the treatment zone and adjacent tissues. The catheter must provide a protective surface area within the renal pelvis by supporting the urothelium and preventing urothelial tissue from occluding openings within the catheter during application of negative pressure through the catheter lumen. For example, establishing a three-dimensional shape or void volume that is free, or essentially free, of urothelial tissue ensures patency of the fluid column or flow from each of the one million renal units into the drainage lumen of the catheter.

Because the renal pelvis is composed of longitudinally oriented smooth muscle cells, a protective surface area would ideally incorporate a multiplanar approach to establishing the protected surface area. Anatomy is often described in three planes: sagittal (vertical anterior-posterior, dividing the body into right and left portions), coronal (vertical left-right, dividing the body into dorsal and ventral portions), and transverse (horizontal or axial, dividing the body into superior and inferior portions and perpendicular to the sagittal and coronal planes). Smooth muscle cells within the renal pelvis are vertically oriented. It is desirable for the catheter to also maintain radial surface area across the many transverse planes between the kidney and ureter. This allows the catheter to account for both the longitudinal and horizontal portions of the renal pelvis in establishing the protective surface area 1001. Additionally, given the flexibility of the tissue, protection of these tissues from openings or orifices leading to the lumen of the catheter tool is desirable. The catheters discussed herein may be useful for delivering negative pressure, positive pressure, or may be used at ambient pressure, or any combination thereof.

In some embodiments, a deployable/retractable expansion mechanism is utilized that, when deployed, creates and/or maintains a patent fluid column or flow between the kidney and the catheter drainage lumen. When deployed, the deployable/retractable mechanism creates a protective surface area 1001 within the renal pelvis by supporting the urothelium and preventing the urothelial tissue from blocking the opening in the catheter during application of negative pressure through the catheter lumen. In some embodiments, the retention portion is configured to extend to a deployed position in which the diameter of the retention portion exceeds the diameter of the drainage lumen portion.

With reference to the figures, disclosed herein is a pump assembly, generally designated as 100, 500, or a pump system, generally designated as 600, 800, comprising a pump 110, 510, 612, 812 for increasing urine output from a patient. The pump 110, 510, 612, 812 can be positioned at least partially within the patient's body, for example, within a body cavity or conduit such as the urinary tract. In other examples, the pump 110, 510, 612, 812 may be positioned within the patient's body outside the urinary tract, such as within the patient's abdominal cavity, peritoneum, or subcutaneous space.

In some embodiments, the pump 110, 510, 612, 812 may be an indwelling pump configured to be positioned within a portion of a patient's body. An "indwelling pump" may be inserted, for example, through a bodily orifice. For example, as described in further detail herein, the pump 110, 510 may be inserted into the patient's urinary tract through the urethral orifice and deployed within the bladder or ureter.

In some embodiments, pump 110, 510, 612, 812 may be an implantable pump. As used herein, a pump is "implantable" or "implanted" by insertion through an incision through the patient's skin. An "implantable pump" may be secured in place, for example, within a body cavity, by sutures. As described in further detail herein, pump 610 may be implanted within the patient's abdominal cavity, peritoneum, or subcutaneous cavity.

The pump assemblies 100, 500 and pump systems 600, 800 disclosed herein can be configured for use by ambulatory patients to provide continuous or cyclic negative pressure therapy to the renal pelvis and/or kidneys over extended treatment periods, such as treatment periods of several days, weeks, or more. As used herein, an "ambulatory patient" refers to a patient who, while receiving negative pressure therapy, is able to stand, move from a first location to a second location, e.g., by walking or being pushed in a wheelchair, and perform normal activities of life without being hindered or restricted by the components of the pump assembly 100, 500 or system 600, 800. Thus, for use with ambulatory patients, the components of the pump assembly 100, 500 or system 600, 800, particularly the pump mechanism, catheter, electronic processing and control circuitry, and power supply components, are either implanted or worn by the patient to allow the patient to move and perform normal activities without being restricted by the pump assembly or system components. For wheelchair-bound patients, some components of pump assembly 100, 500 or system 600, 800 may also be attached to the wheelchair rather than worn by the patient. Also, any wires or tubing of pump assembly 100, 500 or system 600, 800 external to the patient's body should be short in length to avoid restricting the patient's mobility. Furthermore, in some embodiments, pump assembly 100, 500 or system 600, 800 for ambulatory patients drains urine into the bladder rather than into an external urine collection container, as in some previous embodiments. In some embodiments, urine drained into the bladder is removed from the bladder by a conventional bladder catheter inserted through the urethra, as is known in the art.

In contrast, pump assemblies and systems for use in treating non-ambulatory patients, such as those confined to a hospital bed or who must remain in a seated position, may include stationary or non-wearable components, such as pump assemblies that include external pumps, tubing, and wires. These components may limit the patient's mobility, meaning that such components cannot be used by ambulatory patients. Such assemblies for non-ambulatory patients may also include a urine collection container that is connected to the urinary tract, for example, through a urinary catheter. However, it should be understood that the pump assemblies 100, 500 or systems 600, 800 disclosed herein may also be used to provide negative pressure therapy for non-ambulatory patients.

In some embodiments, a pump assembly 100, 500 or pump system 600, 800 is provided. The pump assembly 100, 500 or pump system 600, 800 is configured to increase urine output from a patient. The pump assembly 100, 500 or pump system 600, 800 includes at least one urinary catheter 614, 814, also referred to as an inlet line 146, and a pump 110, 510, 612, 812. At least a portion of the pump assembly 100, 500 or pump device 612, 812 is configured to be positioned within the patient's body. The pump assembly 100, 500 or pump system 600, 800 may further include a controller 112, 644, 844 coupled to the pump 110, 510, 612, 812 configured to direct movement of the pump 110, 510, 612, 812. At least one (one or more) of the pump 110, 510, 612, 812, controller 112, 644, 844, or power supply may be positioned within the patient's urinary tract or any body cavity. In other examples, the controller 112, 644, 844 and/or power supply can be positioned outside the patient's body, if desired. The pump 110, 510, 612, 812 may include at least one pump element positioned within the fluid flow channel to draw fluid through the channel. The urinary catheter includes a distal portion including a retention portion configured to be positioned within the patient's kidney, renal pelvis, and/or ureter, and a proximal portion including a drainage lumen. The retention portion may include at least one drainage port to allow fluid flow into the drainage lumen. The pump 110, 510, 612, 812 is configured to provide negative pressure to at least one of the patient's renal pelvis or kidney through an outlet lumen of the at least one ureteral catheter. The pump 110, 510, 612, 812 can include at least one fluid port in fluid communication with the outlet lumen of the proximal portion of the ureteral catheter for receiving fluid from the patient's kidney.

For ease of discussion, the pump assembly 100 will be discussed herein with reference to use in conjunction with the urinary tract; however, those skilled in the art will understand that the pump assembly 100 can be used in a similar manner for drainage of fluids from any body cavity or duct. With specific reference to FIG. 1A , a patient's urinary tract, generally designated 2, comprises the patient's right kidney 4 and left kidney 6. The kidneys 4, 6 are responsible for blood filtration and clearance of waste compounds from the body through urine. Urine produced by the right kidney 4 and left kidney 6 drains through renal tubules, i.e., the right ureter 8 and left ureter 10, into the patient's bladder 12. For example, urine may be conducted through the ureters 8, 10 by peristalsis of the ureter walls as well as by gravity. The ureters 8, 10 and/or distal portions 9 of the kidneys 4, 6, known as the renal pelvis 14, 16, are conical, receptacle-shaped structures extending between the ureters 8, 10 and the kidneys 4, 6. The ureters 8, 10 enter the bladder 12 through ureteral orifices or openings 24, 26. The bladder 12 is a flexible, substantially hollow structure adapted to collect urine until it is excreted from the body. The bladder 12 is transitionable from an empty position (indicated by reference line E) to a full position (indicated by reference line F). Typically, once the bladder 12 reaches a substantially full state, urine is allowed to exit the bladder 12 into the urethra 18 through a urethral opening or sphincter 20 located in the lower portion of the bladder 12. Contractions of the bladder 12 may be responsive to stress and pressure exerted on the trigone region 22 of the bladder 12, which is a triangular region extending between the ureteral orifices 24, 26 and the urethral opening or sphincter 20. The trigone region 22 is sensitive to stress and pressure, such that as the bladder 12 begins to fill, pressure on the trigone region 22 increases. Once a threshold pressure on the trigone region 22 is exceeded, the bladder 12 begins to contract, expelling collected urine through the urethra 18.

1A-1D, 2A, and 2B, which illustrate the urinary tract 2, in some embodiments, the pump assembly 100 includes a pump 110. As described in further detail herein, in some embodiments, the pump 110 includes an inlet for receiving fluid from a patient's ureter or from a proximal portion of a ureteral catheter, and an outlet configured to discharge fluid into the patient's bladder or into an outlet catheter, for example, for directing fluid from the pump 110 to the patient's bladder or through the urinary tract 2 to a container external to the patient. At least a portion of the pump 110 is configured to be positioned within at least one of the patient's internal portions 28, 30 of the ureters 8, 10, the internal portions 32, 34 of the renal pelvis 14, 16, the internal portion 40 of the bladder 12, or the internal portion of the urethra 18. For example, the pump 110 can be configured to be positioned within the proximal portion 11 or the distal portion 9 of the patient's ureters 8, 10 and/or renal pelvis 14, 16. The pump 110 can be used to provide negative or positive pressure within at least one of the patient's ureters 8, 10 or kidneys 4, 6, as desired.

An exemplary pump assembly 100 is shown in FIGS. 2A and 2B. The pump assembly 100 includes a pump 110 configured to be positioned within an internal portion 28, 30 (e.g., proximal portion 11 or distal portion 9) of the patient's ureter 8, 10 and/or renal pelvis 14, 16 or internal portion 32, 34 of the kidney to provide negative or positive pressure to the patient's ureter 8, 10 and/or kidney 4, 6, and a controller 112 configured to be implanted and/or deployed within a portion of the ureter 8, 10 and/or renal pelvis 14, 16 or elsewhere within the patient's urinary tract 2, e.g., within the bladder 12 or urethra 18.

In some embodiments, the present disclosure is directed to various indwelling or implantable pumps. As shown in Figures 1A-1D, 2A, and 2B, pump 110 can be positioned within a portion of the urinary tract 2. In other embodiments, one or more pumps can be implanted in any convenient location within the patient's body. The pump is generally configured to draw urine from the renal pelvis and/or kidney. In some embodiments, the pump conducts fluid from the body through one or more drainage catheters. In other embodiments, the pump drains fluid into the bladder, where it can be drained from the body through the urethra.

As discussed in further detail below, to induce negative or positive pressure, the pump 110 includes a pump mechanism or element 126 (shown in FIG. 2B ) that, while positioned within the interior portions 28, 30 of the ureters 8, 10, the interior portions 32, 34 of the renal pelvis 14, 16, the interior portion 40 of the bladder 12, or the interior portion of the urethra 18, is activated continuously or periodically to draw fluid into the flow channel 122 of the pump 110, thereby inducing negative or positive pressure within the ureters 8, 10 and/or kidneys 4, 6. The pump element 126 can be positioned at least partially within the channel 122 such that, when activated, it draws fluid through the channel 122 between the open distal end 118 and the open proximal end 116 of the housing 114 in the direction of arrow A1. The pump element 126 can operate for a predetermined period of time, e.g., a daily period, or can operate continuously. The time period of pump operation can be varied as desired. Pump element 126 can comprise different types of molded or machined components as known in the art, including impellers, threads, pistons, one-way valves, check valves, and similar structures for drawing fluid through the pump, as will be described herein. In some examples, pump element 126 comprises a piezoelectric film or surface configured to transition from an extended configuration to a retracted configuration and draw fluid through the pump, as described below.

When actuated, the pump 110 draws fluid F1 (e.g., urine) from the kidneys 4, 6 and ureters 8, 10 and moves the fluid F1 into or through the bladder 12 and outside the patient's body, thereby inducing negative pressure within the urinary tract. The rotation or actuation of the pump element 126 can be reversed to provide positive pressure, if desired.

In some embodiments, fluid F1 is drained into bladder 12 by pump 110. In other embodiments, fluid F1 can be conducted through outlet line 158, such as a tube or conduit, through the inside of urethra 18 to the outside of the body. Fluid F1 can be collected in a fluid collection container (not shown) located outside the patient's body. Pump 110 may be configured to deliver a negative pressure, as measured at the inflow port of pump 110, in the range of 0 to about 150 mmHg, or about 5 mmHg to about 100 mmHg, or about 10 mmHg to about 50 mmHg. Pump 110 may be configured to intermittently deliver a positive pressure, as measured at the inflow port of pump 110, in the range of about 0 to about 150 mmHg, or about 1 mmHg to about 100 mmHg, or about 1 mmHg to about 50 mmHg. The pump 110 can be configured to provide a volumetric fluid flow rate of 0 to about 3.5 mL/min, about 0.2 mL/min to about 2.5 mL/min, or about 0.4 mL/min to about 1.25 mL/min. Generally, the amount of negative or positive pressure delivered by the pump and/or volumetric flow rate is determined from pump operating parameters (e.g., the pump is configured to deliver a predetermined negative pressure or extract fluid at a predetermined flow rate). However, in some examples, the pump 110 can include a pressure sensor to directly or indirectly measure the negative and/or positive pressure exerted by the pump 110 on the ureter and/or kidney, and/or a flow rate sensor to measure the volume of fluid drawn through the pump 110. As described herein, the negative or positive pressure may be applied continuously or intermittently pulsed to drive a continuous or pulsatile flow.

As described herein, pump element 126 may be, for example, a microelectromechanical component as known in the art, e.g., an Abiomed® Impella® pump, or a piezoelectric pump such as those manufactured by Dolomite. Other processing techniques for producing components of pump 110 configured for insertion within ureters 8, 10, renal pelvises 14, 16, or urethra 18 may include, for example, injection molding, three-dimensional printing, metal stamping, and similar processing techniques as known in the art. For example, as shown in FIGS. 7 and 8 , pump element 126 may include impeller 1 and/or a deformable, movable, and/or expandable piezoelectric element 180. As described in more detail below with respect to FIG. 11 , in some embodiments, the pump element 126 can be operably connected to electrical components including a motor (e.g., drive mechanism 228), a power source (e.g., battery 226 and/or induction coil 210), and an on/off switch or controller 218, as well as to different types of optional sensors for measuring pump operating parameters and/or physiological information about the patient as discussed herein.

2A and 2B, in some embodiments, the pump 110 includes a housing 114 that can at least partially enclose the pump element 126 and/or can partially define the flow channel 122. At least a portion of the housing 114 can be configured to be positioned within the interior portions 28, 30 of the ureters 8, 10, the interior portions 32, 34 of the renal pelvis 14, 16, the interior portion 40 of the bladder 12, or the interior portion of the urethra 18. The housing 114 includes an open proximal end 116, an open distal end 118, and a sidewall 120 extending therebetween that defines a flow channel 122 for conducting fluid F1 through the interior portions 28, 30 of the patient's ureters 8, 10, the interior portions 32, 34 of the patient's renal pelvis 14, 16, the interior portion 40 of the patient's bladder 12, or the interior portion of the patient's urethra 18 (depending on where the pump 110 is positioned), and for moving fluid into or through the patient's bladder 12 or urethra 18 to the exterior of the patient.

As described in further detail herein, the open proximal end 116 and the open distal end 118 of the housing 114 are sized to fit within a particular portion of the patient's urinary tract 2, such as the ureter. The housing 114 may have a diameter ranging from about 3 mm to about 8 mm, or from about 4 mm to about 7 mm, and a length ranging from about 5 mm to about 30 mm, about 10 mm to about 25 mm, or about 15 mm to about 20 mm. The pump flow channel 122 may have a diameter ranging from about 1 mm to about 6 mm, or about 2 mm to about 5 mm. In other embodiments, the housing 114 may be tapered to facilitate positioning of the distal portion of the housing 114 within the ureter 8, 10, renal pelvis 14, 16, or urethra 18. For example, a taper of about 0 to about 6 degrees may be used. In other embodiments, the housing 114 may have a non-circular cross-section. For example, the cross-section of the housing 114 may be square, rectangular, another polygon, or a combination thereof. For housing 114 having a square or rectangular cross-section, each side of the cross-section can have a width of about 3 mm to about 8 mm or about 4 mm to about 7 mm. In some examples, housing 114 can have a substantially smooth outer surface to improve patient comfort.

In some embodiments, the housing 114 has a maximum external or outer diameter D1 of about 0.5 mm to about 3.0 mm or about 2.0 mm to about 2.5 mm. The outer diameter D1 can be selected to correspond to the average ureteral inner diameter so that the pump 110 fits snugly within the ureter.

In some embodiments, the pump 110 may at least partially seal the ureter, prevent urinary bypass leakage, and/or maintain negative pressure. In some embodiments, the outer cross-section of the housing 114 of the pump 110 may be sized to fill the interior cross-section of the ureter. Engagement of ureteral tissue with the housing 114 may at least partially seal the ureter, prevent urinary bypass leakage, and/or maintain negative pressure. In one embodiment, the housing 114 may be substantially cylindrical, and the outer diameter of the housing 114 may be equal to or greater than the inner diameter of the ureter. In some embodiments, as shown in FIG. 2B , to facilitate formation of a suitable seal, a flexible and/or resilient elastomeric structure may be positioned about a portion of the exterior of the pump 110 to at least partially seal the ureter. For example, an annular seal 124 extending around the circumferential outer surface 121 of the sidewall 120 of the pump 110 can be attached to or centered about a portion of the pump 110 to form the seal 124 between the housing 114 and the adjacent inner wall 13 of the ureter 8, 10. The seal 124 can be formed from one or more elastomeric biocompatible materials, such as silicone, polyurethane, polyolefin, or a hydrogel such as alginate.

Housing 114 can be shaped as desired to facilitate positioning within the ureter, renal pelvis, bladder, or urethra, and to accommodate the pump elements (discussed below) and flow channels. In some embodiments, housing 114 is a generally cylindrical structure having a substantially similar circular cross-section along its entire length.

Housing 114 can be formed from one or more suitable biocompatible materials, such as medical grade plastics (e.g., high density polyethylene, polycarbonate, and silicone materials) and/or metals (e.g., surgical stainless steel).
Pump Elements and Associated Electronic Components

An exemplary pump element 126 of pump 110 is shown in FIGS. 7 and 8. As previously discussed, pump element 126 can be positioned at least partially within channel 122 defined by pump housing 114. When activated, pump element 126 draws fluid, such as urine produced by the kidneys, into channel 122 through open distal end 118 of housing 114 and expels fluid through open proximal end 116 of housing 114. In some examples, pump element 126 may also propel fluid through channel 122 defined by controller housing 128 (shown in FIG. 2B) into the patient's bladder or through a tube through the bladder and urethra to the outside of the patient's body.

As shown in FIG. 7 , in some embodiments, the pump element 126 includes a rotatable impeller 170 positioned within the channel 122. The impeller 170 can be made from a variety of medical-grade materials that are strong and rigid enough to rotate for extended periods of time without deforming or bending. For example, the impeller 170 can be formed from a metallic material, such as surgical stainless steel, and/or from a rigid plastic material, such as polycarbonate. For example, the impeller 170 can include two or more blades 172 mounted on a central rotor 174 and positioned to rotate about the central rotor 174 in the direction of arrow A3. The impeller 170 can have two to four or more blades. The blades 172 can have a length of about 8 mm to about 14 mm, or about 10 mm to about 12 mm, and a width of about 2 mm to about 3 mm. The clearance between the blades 172 can be about 0.02 mm to about 1 mm, or about 0.5 mm to about 0.8 mm. As shown in FIG. 7 , the rotor 174 can extend longitudinally through the channel 122 along its central longitudinal axis L4. The blades 172 can include straight or curved surfaces 176 configured to contact fluid passing through the channel 122. In some examples, the blades 172 can also rotate about the rotor 174 in the opposite direction, if desired, to apply positive pressure to the ureter and/or kidney. The blades 172 can have any suitable shape that, when rotated, is capable of drawing fluid through the channel 122. For example, as shown in FIG. 7 , the edges 178 of the blades 172 can be straight, curved, or have an "S"-shaped configuration. As discussed above, the pump element 126 and impeller 170 can be operably connected to a drive mechanism or electric motor that, when activated, rotates the blades 172 as described herein.

As shown in FIG. 8 , another exemplary pump element 126 includes a piezoelectric diaphragm 180 configured to transition between a contracted position (indicated by dashed lines in FIG. 8 ) and an extended position (indicated by solid lines in FIG. 8 ), where the piezoelectric diaphragm 180 expands into the channel 122, restricting flow therethrough and reducing the volume and cross-sectional area of the channel 122. The piezoelectric diaphragm 180 can be formed from a thin, flexible conductive film, such as a polymer and/or elastomeric film, as known in the art, or from stainless steel. The piezoelectric diaphragm 180 can be electronically coupled to a driving mechanism, such as a signal generator or power supply, for activating the piezoelectric diaphragm 180. For example, the diaphragm 180 can be activated by passing an electrical signal generated by a signal generator or power supply through the conductive film of the diaphragm 180, transitioning the diaphragm 180 to the extended position. During use, one side of the piezoelectric diaphragm 180 is exposed to fluid, and the drive mechanism is located on the unexposed side of the piezoelectric diaphragm 180. The pump element 126 further includes valves 182, 184, such as one-way valves and/or check valves, positioned at the open distal end 118 and the open proximal end 116 of the channel 122, respectively, as shown in FIG. 8. The one-way and/or check valves 182, 184 may be conventional one-way valves configured to limit the backflow of fluid, as is known in the art. Exemplary one-way and/or check valve mechanisms may include, for example, flexible flaps or covers, ball valves, piston valves, or similar mechanisms.

In operation, fluid is drawn into the channel 122 through the distal valve 182 by contraction of the piezoelectric diaphragm 180, as shown by arrow A1 in FIG. 8 . For example, the flap 188 of the distal valve 182 may pivot in the direction of arrow A4 to an open position, allowing fluid to pass therethrough. As a result of the negative pressure created by the contraction or collapse of the diaphragm 180, the proximal valve 184 is forced to close, as shown by arrow A5, to prevent the backflow of fluid. Once the diaphragm 180 has contracted or collapsed a predetermined amount, the movement of the diaphragm 180 is reversed by applying an electrical signal to the conductive film. As the diaphragm 180 expands, the distal valve 182 closes to prevent backflow of fluid, and fluid is expelled from the channel 122 through the open proximal valve 184, through the open proximal end 116 of the housing 114, into the lower ureteral portion 11, and through the urethra 18.
(controller)

The pump assembly 100 further includes a controller 112 configured to be positioned inside at least one of the second internal portion of the patient's ureter 8, 10, the second internal portion of the patient's renal pelvis 14, 16, the second internal portion of the patient's bladder 12, or the second internal portion of the patient's urethra 18. The controller 112 may comprise a module or device that communicates wired or wirelessly with one or more other modules or devices, thereby forming a patient treatment system. The controller 112 may comprise part of a single device or assembly, or multiple devices or assemblies, e.g., enclosed within a single device housing or multiple housings. In some embodiments, the controller 112 includes processing circuitry configured to execute instructions and perform functions based on the executed instructions. In that case, the same processing component may perform the functions of different components of the pump assembly 100. For example, a single processor or microprocessor may be configured to perform the functions of both the pump 110, including activating and deactivating the operation of the pump mechanism or pump element 126 and the controller 112, such as receiving and processing data transmitted from a remote device.

In some embodiments, the controller 112 comprises electronic circuitry, such as a controller or microprocessor, comprising a computer-readable memory comprising instructions that, when executed, control pump operating parameters (e.g., flow rate, operating speed, operating duration, etc.). For example, the controller or processor can be configured to output instructions to the pump 110 to cause the pump 110 to turn on, turn off, or adjust the operating speed. The controller 112 can further comprise one or more communication interfaces for communicating instructions to the pump 110 and for communicating information about the treatment provided to the patient and measured patient parameters to a remote device or data collection facility. For example, the communication interface may be configured to wirelessly transmit data about the patient and the treatment provided to the patient to a patient treatment facility for inclusion in a patient health record.

The pump 110 and controller 112 may be integrally formed or directly connected, for example, as shown in FIGS. 2A and 2B. In other examples, a separate pump and controller may be connected by a wireless or wired connection, as shown in FIG. 3. In some examples, the wires extending between the pump 110 and controller 112 may extend the majority of the length of the ureter, such that the pump 110 may be positioned in the renal pelvis region and the controller 112 may be positioned in the patient's bladder 12. In other examples, the pump 110 may wirelessly communicate with the controller 112, which may be remote from the pump 110. For example, a remote control device 310 (shown in FIG. 12), such as a device positioned outside the patient's body, may be used to control the pump 110.

The controller 112 is operatively connected to and/or communicates with the components of the pump 110, including the pump element 126, to direct the movement of the pump element 126 and control the flow rate of the fluid F1 passing through the patient's ureters 8, 10, the patient's renal pelvis 14, 16, the patient's bladder 12, or an internal portion of the patient's urethra 18.

In some embodiments, the controller 112 comprises a housing 128. At least a portion of the housing 128 is configured to be positioned within the interior portions 28, 30 of the ureters 8, 10, the interior portions 32, 34 of the renal pelvis 14, 16, the interior portion 40 of the bladder 12, the interior portion of the urethra 18, and/or elsewhere within the urinary tract 2. The housing 128 comprises a distal end 132, a proximal end 130, and a sidewall 134 extending therebetween. The length L3 of the controller 112 can be based on its intended location within the urinary tract. For example, the controller 112 can have a length L3 of about 1 cm to about 5 cm or about 2 cm to about 4 cm. In some embodiments, the controller 112 can have a maximum outer diameter D2 that exceeds the maximum outer diameter D1 of the pump housing 114. The diameter D2 of the controller 112 is also variable based on the intended deployment location. For example, the controller 112 may have a diameter D2 of about 5 mm to about 20 mm, or about 10 mm to about 15 mm.

The controller housing 128 can be shaped as desired to facilitate positioning within the ureter 8, 10, renal pelvis 14, 16, bladder 12, or urethra 18, and to accommodate the controller 110 and flow channel (if present). In some embodiments, the controller housing 128 is a generally cylindrical structure having a substantially similar circular cross-section along its entire length. In other embodiments, the controller housing 114 can be tapered to facilitate positioning of the distal portion of the controller housing 128 within the ureter 8, 10, bladder 12, or urethra 18. For example, a taper of about 0 to about 6 degrees may be used. In other embodiments, the controller housing 128 can have a non-circular cross-section. For example, the cross-section of the controller housing 128 can be square, rectangular, or another polygonal shape.

In some embodiments, the controller housing 128 is a generally cylindrical structure. The controller housing 128 can optionally include a flow channel 136 therethrough. The flow channel 136 can have an inner diameter ranging from about 1 mm to about 6 mm or from about 2 mm to about 5 mm. The interior shape of the flow channel 136 can have any shape as desired, and in some embodiments, can be generally cylindrical to promote flow therethrough. The controller housing 128 can be formed from a biocompatible metal or plastic material similar to the pump housing 114 described above. Generally, the maximum outer diameter D2 can be sufficient to position the controller 112 within the patient's bladder 12 and, therefore, can be wider than the diameter of the ureteral orifices 24, 26 (shown in FIG. 1A ) and the inner diameter of the ureters 8, 10 so that the controller 112 remains within the bladder and is not drawn into the ureters along with the pump 110.

The controller 112 further includes electronic circuitry for operating the pump element 126, including components for controlling and regulating the pump flow rate, the negative and/or positive pressure generated, power usage, and other operating parameters. Exemplary electronic components of the pump assembly 100, particularly the controller 112, are shown in FIG. 11 and described in detail below.

2A and 2B, in some embodiments, the pump 110 and the controller 112 can be integrally formed such that the separate housings 114, 128 are directly connected to one another. For example, as shown in FIGS. 2A and 2B, the proximal end 116 of the pump 110 is connected to and/or integrally formed with the distal end 132 of the controller 112. In that case, the channel 122 of the pump 110 is directly connected to and in fluid communication with the channel 136 of the controller 112 such that fluid F1 is drawn from the ureters 8, 10, renal pelvis 14, 16, bladder 12, or urethra 18 through the flow channel 122 of the pump 110 and the flow channel 136 of the controller 112, drains from the open proximal end 130 of the controller 112 into the patient's bladder 12 or through tubing, and conducts the fluid through the bladder 12 and urethra 18 to the outside of the patient's body.

As shown in FIG. 3, in another embodiment of the pump assembly 100, the controller housing 128 is separate from the pump housing 114. In that case, as shown in FIG. 3, the pump 110 and controller 112 are connected via a wireless or wired connection formed by one or more wires 138 extending between the pump 110 and the controller 112. In some embodiments, the wires 138 are coated with a suitable biocompatible sheath or coating to provide suitable insulation and to facilitate insertion and/or removal of the wires 138 from the urinary tract. For example, polymer coatings such as polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, or silicone may be used. In this embodiment, the controller housing 128 may optionally include a flow channel 136.

The wires 138 can be configured to conduct electronic signals between the pump 110 and the controller 112, comprising operational commands from the controller 112 to the pump elements 126 of the pump 110, for example, to control or regulate the speed of operation and/or to activate or deactivate the operation of the pump elements 126. Operating parameters and/or information sensed by the electronic components of the pump 110 may be transmitted to the controller 112 via a wired connection for processing, analysis, and/or transmission from the controller 112 to a remote source. In some examples, the wires 138 between the pump 110 and the controller 112 are fairly short in length, meaning that the pump 110 is configured to be positioned within the proximal portions 11 of the ureters 8, 10 near the ureteral orifices 24, 26 into the bladder 12. In other configurations, the wire 138 is approximately the length of the ureters 8, 10, meaning that the pump 110 may be positioned within the renal pelvis 14, 16 and/or kidneys 4, 6, while the controller 112 may be positioned within the ureters 8, 10 and/or bladder 12. For example, the wire 138 may have a length L1 of from about 1 cm to about 35 cm or from about 15 cm to about 25 cm, since the average ureteral length in an adult is from about 25 cm to about 30 cm.
(power supply)

In some embodiments, the controller 112 further comprises an internal or external power source 200 for providing power for the controller 112 and the pump elements 126 or mechanism electronic circuitry of the pump 110. The power source 200 may, in some embodiments, be a disposable or rechargeable battery that can be recharged, for example, via inductive power transfer through a small induction coil deployed within the bladder or elsewhere in the body or outside the body. The induction coil may be configured to generate power when exposed to an electromagnetic field generated by a remote device outside the patient's body. For example, the remote device may be a computerized device such as a smartphone or computer tablet. In other embodiments, the remote device may be a non-computerized device circuit that includes circuitry for generating the electromagnetic field. In one embodiment, a blanket including an electromagnetic field-generating electromagnetic circuit can be wrapped around the patient while they sleep. The electromagnetic field-generating circuit can induce the induction coil to generate power overnight, or at least until the rechargeable battery is fully charged. Because a patient is less likely to move while asleep than while awake, the portion of the blanket that generates the electromagnetic field is likely to remain in close proximity to the pump assembly 100 and induction coil for a substantial period of time.

In some embodiments, the pump assembly 100 further includes a power supply 200, shown in FIGS. 9 and 10. The power supply 200 includes an inductive coil 210 that is electronically coupled to the pump 110 and/or to the controller 112. Inductive coils for short-range wireless energy transfer are known and are used, for example, to charge portable low-power electronic devices such as cell phones, laptop computers, small appliances, and power tools. An exemplary inductive coil is the eCoupled system developed by Fulton Innovation, described in U.S. Patent No. 6,975,198, entitled "Inductive Coil Assembly." Other known or later-developed inductive systems that can be positioned within a patient's body and used to generate sufficient power to operate a microelectromechanical device or system may also be used within the scope of the present disclosure.

As described herein, the induction coil 210 generates and provides electrical power to the pump assembly 100 to operate the pump 110 and the controller 112. For example, the power generated by the induction coil 210 can be used to recharge a rechargeable battery, provide power for sensors disposed within the pump 110, and/or for wireless data transmission between the pump assembly 100 and an external device. In some embodiments, as discussed herein, the induction coil 210 generates electrical power when exposed to an electromagnetic field generated by another device. For example, the electromagnetic field can be generated by a remote control device 310 (shown in FIG. 12 ) positioned outside the patient's body. The remote control device 310 can be worn, for example, in a holster, carrying case, waist bag, or pocket, and positioned so that the remote device 310 is held flat against the patient's body and as close to the induction coil 210 as possible.

In the example shown in FIGS. 9 and 10, the induction coil 210 comprises a flexible sheet 212, such as a polymer sheet, and conductive wires 214 embedded in or attached to the flexible sheet 212. For example, the wires 214 may be attached to the flexible sheet 212 in a spiral pattern, a zigzag pattern, or any other suitable pattern. The induction coil 210 may be connected to the pump assembly 110 by one or more wires or cables 216. For example, the coil 210 may be connected to the controller 112 through a cable 216 extending from the proximal end 130 of the controller 112.

In some embodiments, the flexible sheet 212 is transitionable between a rolled configuration 234 (as shown in FIG. 13B) and an unrolled or deployed configuration 236 (as shown in FIGS. 9 and 10). In some cases, the flexible sheet 212 may be configured to deploy automatically. For example, the sheet 212 may be biased to unroll automatically when released from the deployment catheter 410 (as shown in FIGS. 13A and 13B). In other embodiments, the coil 210 may include a manual release mechanism, such as a release button or trigger wire. When a user depresses the release button or pulls the trigger wire, the latching mechanism that maintained the coil 210 in the rolled configuration 234 releases, allowing the flexible sheet 212 to unroll, thereby transitioning the sheet 212 to the deployed configuration 236.

The induction coil 210 can be positioned at any convenient location within the patient's urinary tract 2. For example, as shown in Figure 10, the induction coil 210 can be operably connected to the controller 112 and positioned within the patient's bladder 12 at a location proximal to the controller 112. Alternatively, the induction coil 210 may be positioned within the abdominal cavity, outside the bladder, within the peritoneal cavity, any other convenient location in vivo, or external to the patient.
(Pump Assembly Electrical Components)

Exemplary electronic components of the pump assembly 100 are shown in the schematic diagram of FIG. 11. As previously described, the pump assembly 100 includes a pump 110, a controller 112, and a power source 200, such as an induction coil 210 or a battery 226 (shown in FIG. 11). The induction coil 210 can be operably coupled to the controller 112 by a cable 216 to provide power to the controller 112.

The controller 112 comprises a controller 218 and associated transient or non-transient computer-readable memory 220. The controller 218 may comprise, for example, one or more general-purpose microprocessors configured to communicate with the pump 110 and receive and implement instructions to operate the pump by, for example, activating or deactivating the operation of the pump elements 126 and/or regulating the speed of operation, and controlling the negative and/or positive pressure delivered to the patient.

In some embodiments, the controller 218 can be configured to control communications between the pump assembly 100 and one or more remote control devices 310 (shown in FIG. 12) located external to the patient. In that case, the controller 112 may further include a communications interface 222, which may include, for example, a wireless transmitter or antenna. The communications interface 222 can be configured to receive commands from a remote source (e.g., the remote control device 310 shown in FIG. 12) and to emit signals that control operation of the pump elements based on the received commands.

The controller 112 further includes a power distribution and management circuit 224. As shown in FIG. 11, the power management circuit is electrically coupled to the induction coil 210. The power distribution circuit 224 can be configured to receive the power generated by the induction coil 210 and to control the distribution of the generated power to other system components.

In some examples, the controller 112 may further include a battery 226, such as a rechargeable battery, operably connected to the controller 218 and the power distribution circuitry 224. The battery 226 can be recharged from power generated by the induction coil 210. When power is not being generated by the induction coil 210, the system components can continue to operate using the power provided by the battery 226. The battery 226 can be any battery that is small enough to fit within the controller housing 128 and approved for in vivo use. For example, batteries used in pacemakers and similar implanted devices may be suitable for use with the pump assembly 100 described herein.

As previously described, the electronic components of the controller 112, including the controller 218, are in electronic communication with the electrical components of the pump 110, for example, through connecting wires 138 (shown in FIGS. 3, 9, and 11) or by another suitable electronic connection. Power generated by the induction coil 210 can be provided to the electronic components of the pump 110 through wires 138. Additionally, operating instructions generated by the controller 218 can be provided to the components of the pump 110 to control pump operating parameters. In a similar manner, information collected or generated by the components of the pump 110 can be communicated to the controller 218 for further processing and/or wireless transmission to a remote device.

As shown in FIG. 11 , the pump 110 includes a pump element 126 and associated electronic components. For example, the pump 110 can include a drive mechanism 228, such as an electric motor or a signal generator, operably connected to the pump element 126. A variety of different drive mechanisms 228 can be used in connection with the pump 110, depending on the type of pump element 126 being used. For example, for an impeller-type pump arrangement (as shown in FIG. 7 ), the drive mechanism 228 can include an electric motor that rotates the impeller. In other examples, the drive mechanism 228 can include an electromagnetic element disposed around the impeller 170 that turns on and off in a predetermined pattern to rotate the impeller 170 at a desired speed. If the pump element 126 is a piezoelectric element 180, the drive mechanism 228 can include a signal generator to generate an electric current and transition the piezoelectric element 180 between a contracted state and an expanded state.

In some examples, pump 110 can further include one or more sensors (e.g., pump sensor 230 and physiological sensor 232) positioned within flow channel 122 of pump 110 to measure information about pump operating conditions and/or about the fluid passing through channel 122. For example, pump sensor 230 can include a flow sensor to verify that fluid is passing through channel 122 and/or to measure the flow rate. Pump sensor 230 can also include a sensor to measure the amount of negative and/or positive pressure generated or the pump impeller rotation speed. Physiological sensor 232 can include one or more sensors to measure information about the fluid passing through channel 122 and to determine information about the patient's physiological condition. Exemplary physiological sensors 232 can include, for example, a capacitance and/or analyte sensor to measure information indicative of the chemical composition of generated urine, a pH sensor to measure urine acidity, or a temperature sensor to measure urine temperature.
(Retention member)

In some embodiments, as shown in FIG. 4 , the pump assembly 100 can further include one or more retention members, such as retention barbs 140 and/or barbs 144, for maintaining the position of the pump 110 and/or controller 112 within the patient's urinary tract 2. In some embodiments, the pump housing 114 and/or the controller housing 128 include one or more retention members extending from the sidewalls for releasably attaching a portion of the pump housing 114 to at least one of the interior portions 28, 30 of the ureters 8, 10, the interior portions 32, 34 of the renal pelvis 14, 16, the interior portion 40 of the bladder 12, or the interior portion of the patient's urethra 18. The retention members are retractable to allow removal of the pump 110 from the ureters 8, 10, the renal pelvis 14, 16, the bladder 12, or the urethra 18.

The retention members or barbs 140, 144 can be formed in any suitable pattern or arrangement, such as straight ridges, curved ridges, sharp protrusions, fishhooks, and/or combinations thereof. For example, the retention barbs 140 may be deployable and retractable, in which case the barbs 140 may be in a retracted position as the pump assembly 100 is advanced through the urinary tract. Once the pump assembly 100 is advanced to a desired position, the barbs 140 are deployed to engage a portion of the ureter, renal pelvis, bladder, or urethral wall and retain the pump assembly 100 in the desired position. For example, as shown in FIG. 4, an exemplary pump assembly 100 includes one or more barbs 140 extending radially outward from the sidewall 120 of the pump 110. The barbs 140 may be flat so that the barbs 140 can compress against the sidewall 120 of the housing 114 of the pump 110 to engage ureteral, renal pelvis, bladder, or urethral tissue during removal of the pump assembly 100. Alternatively, the barbs 140 may have any suitable configuration or cross-sectional shape, such as a triangle, a circle, a semicircle, a rectangle, a trapezoid, or a polygon. The barbs 140 may have a longitudinal length L2 that may be at least about 0.25 mm or at least about 0.45 mm, and may be up to about 3.0 mm, up to about 2.5 mm, or up to about 1.5 mm. The barbs 140 may have a width or diameter of about 1.0 mm or less, about 0.8 mm or less, or about 0.5 mm or less. Prior to insertion, the barbs 140 may extend a maximum distance from the sidewall 120 of the pump 110, i.e., a distance of about 1.0 mm or less, about 0.8 mm or less, or about 0.5 mm or less. The barbs 140 may be formed from a semi-rigid or rigid material suitable for maintaining the positioning of the pump 110 within the urinary tract. For example, the barbs 140 may be formed from metal (e.g., surgical stainless steel) or plastic. The barbs 140 may have sharp tips 142 to press against and slightly penetrate the ureteral, renal pelvis, bladder, or urethral wall to maintain the positioning of the pump 110 without perforating the ureteral wall. Because the ureteral wall thickness is approximately 0.05 mm to 0.1 mm, the tips 142 of the barbs 140 should penetrate less than that amount into the ureteral, renal pelvis, bladder, or urethral wall.

In some embodiments, the barbs 140 are retractable. For example, the barbs 140 are biased in a radially outward direction toward the ureter, renal pelvis, bladder, or urethral wall, but can be configured to retract against the side wall 120 of the pump housing 114 as the pump assembly 100 is advanced through a deployment catheter into the patient's ureter, renal pelvis, bladder, or urethra. Once in the deployed position, the barbs 140 may be configured to extend radially outward to the deployed configuration, as shown in FIG. 4 . In other embodiments, the barbs 140 can be extended or retracted by a manually activated trigger mechanism. For example, a user may depress a retraction button or pull a trigger wire, removing the radial bias from the barbs 140 and causing the barbs 140 to retract. After the barbs 140 are retracted, the pump assembly 100 can be safely and easily removed from the urinary tract. For example, the pump 110 and controller 112 can be removed from the body through the bladder and urethral sphincter and then through the urethra.

In some examples, the controller 112 also includes one or more retention members or barbs 144 for anchoring or retaining the controller 112 to the inner surface of the bladder wall, in addition to or instead of the retention members on the pump 110. The barbs 144 may be similar to those discussed above with respect to the barbs 140. For example, as shown in FIG. 5 , retention barbs 144, such as spiral retention barbs, extend from the distal end 132 of the controller 112 in the distal direction D. When positioned within the bladder 12, the barbs 144 are configured to contact a portion 27 of the bladder wall 15 around the ureteral orifices 24, 26 and secure the controller 112 to the bladder wall 15. For example, barbs 144, such as spiral retention barbs, may engage the bladder wall using a twisting action in the direction indicated by arrow A2 (shown in FIG. 5 ). The spiral barbs 144 may be removed from the bladder wall 15 by twisting the controller 112 in the opposite direction, as indicated by arrow A3. In some embodiments, the barbs 144 may be retractable, in which case the user may advance the pump assembly 100 into the urinary tract with the proximal end of the controller 112 in contact with the bladder wall 15. Once the controller 112 is in place, the user deploys the barbs 144 so that they embed into the bladder wall 15 and maintain the positioning of the controller 112 and/or pump 110 within the urinary tract.
(Pump with inlet line)

In other embodiments, as shown in FIG. 6 , the pump 110 can be configured to be positioned within the patient's bladder 12 rather than within the ureters 8, 10. In that case, the housing 114 can be large enough to enclose the electronic components of the controller 112, such as a computer processor and battery. In such a configuration, the pump assembly 100 can further include an inlet line 146 or drain lumen or channel extending from the pump 110 into the patient's ureters 8, 10 and/or renal pelvis 14, 16. For example, the inlet line 146 can be a generally tubular conduit having a proximal end 148 that mounts to a fluid inflow port 150 of the pump 110 and a distal end 152 for placement within the ureters 8, 10 and/or renal pelvis 14, 16. In some embodiments, the inlet line 146 can have an outer diameter ranging from about 0.33 mm to about 3.0 mm or from about 1.0 mm to 2.0 mm. In some embodiments, the inner diameter of the inlet line 146 can range from about 0.165 mm to about 2.39 mm, or from about 1.0 mm to 2 mm, or from about 1.25 mm to about 1.75 mm. In one embodiment, the inlet line 146 is 6 French and has an outer diameter of 2.0±0.1 mm. The inlet line 146 can be formed from one or more suitable biocompatible materials, such as materials used for conventional urinary catheters. Suitable biocompatible materials may be comprised of one or more biocompatible polymers, such as polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone-coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate). Portions of the inlet line 146 may also be made of and/or impregnated with metallic materials such as copper, silver, gold, nickel-titanium alloy, stainless steel, and/or titanium.

In some embodiments, the inlet line 146 includes a plurality of openings 147 or drain holes extending through its sidewall for drawing fluid from the ureter and/or kidney into the interior lumen or flow channel of the line 146. In other embodiments, a portion of the inlet line 146 can be formed from a porous and/or water-absorbent material, such as a sponge, mesh, woven fabric, or similar material. In that case, fluid can be drawn through the porous material into the interior of the lumen or flow channel.

In some embodiments, the distal end 152 of the inlet line 146 includes a retention portion, generally indicated at 154, for maintaining the position of the inlet line 146 at a desired fluid collection location adjacent to or within the ureter 8, 10 and/or renal pelvis 14, 16. Non-limiting examples of suitable retention portions are disclosed in U.S. Pat. Nos. 10,307,564 and 9,744,331, and PCT International Publication No. WO 2017/015345, each of which is incorporated herein by reference in its entirety.

In some embodiments, the retention portion 154 is configured to be flexible and bendable to permit positioning of the retention portion 154 within the ureter and/or renal pelvis. The retention portion 154 is desirably sufficiently bendable to absorb forces exerted on the inlet line 146 and prevent such forces from being transmitted to the ureter. For example, when the retention portion 154 is pulled in the proximal direction P (shown in FIG. 6 ) toward the patient's bladder, the retention portion 154 may be sufficiently flexible to begin to uncoil or straighten so that it can be withdrawn through the ureter. Similarly, the retention portion 154 can be biased to return to its expanded configuration when reinserted into the renal pelvis or other suitable larger area within the ureter.

In some embodiments, the retention portion 154 is integral with the inlet line 146. In that case, the retention portion 154 can be formed by imparting a bend or inflection to the inlet line 146 that is sized and shaped to retain the retention portion 154 at the desired fluid collection location. Suitable bends or coils can include pigtail coils, cork screw coils, and/or helical coils. For example, the retention portion 154 can include one or more radially and longitudinally extending helical coils configured to contact and passively retain the inlet line 146 within the ureter 8, 10 adjacent to or within the renal pelvis 14, 16. In other embodiments, the retention portion 154 is formed from a radially flared or tapered portion of the inlet line 146. For example, the retention portion 154 can further include a fluid collection portion, such as a tapered or funnel-shaped inner surface. In other embodiments, the retention portion 154 may comprise a separate element connected to and extending from the inlet line 146.

6, an exemplary retention portion 154 comprises multiple helical coils, such as one or more full coils and one or more half or partial coils, that are capable of transitioning between a retracted configuration and an deployed configuration. For example, a generally straight guidewire can be inserted through the retention portion 154 to maintain the retention portion 154 in a generally straight, retracted configuration. When the guidewire is removed, the retention portion 154 can transition to its coiled configuration. In some embodiments, coils 156 extend radially and longitudinally in the distal portion 152 of the inlet line 146. In some embodiments, the retention portion 154 can comprise one or more coils 156, each having an outer coil diameter sufficient to contact at least a portion of the inner wall of the ureter and/or renal pelvis and maintain the inlet line 146 at a desired position within the patient's ureter and/or renal pelvis.

In some embodiments, the coiled retention portion comprises at least a first coil 160 having a first outer diameter 162 and at least a second coil 164 having a second outer diameter 166 that is smaller than the first outer diameter 162. As shown in FIG. 6 , the second coil 164 is closer to the base of the retention portion 154 than the first coil 160 (i.e., closer to the end of the distal portion of the drainage channel). The first outer diameter 162 can range from about 12 mm to about 16 mm, or from about 13 mm to about 15 mm. The second outer diameter 166 can range from about 16 mm to about 20 mm, or from about 17 mm to about 19 mm. The retention portion 154 can further comprise a third coil 168 extending about the axis of the retention portion 154. The third coil 168 may have a third outer diameter 169 that is greater than or equal to either the first coil outer diameter 162 or the second coil outer diameter 166. As shown in FIG. 6, the third coil 168 is positioned at the base of the retention portion 154 (i.e., adjacent the end of the distal portion of the drainage channel). The third outer diameter 169 may range from about 12 mm to about 20 mm. The coiled retention portion 154 may have a height H that ranges from about 14 mm to about 18 mm.

In some embodiments, prior to or after insertion into the patient's body, the central axis 190 of the retention portion 154 can be coextensive with, generally parallel to, and/or curved or angled relative to the central axis 192 of the flow channel of the exhaust lumen (inlet line 146). In some embodiments, at least a portion of the axis 190 of the retention portion 154 extends at an angle 194 from the central axis 192 of between 0 and about 90 degrees, or between about 15 and about 75 degrees, or about 45 degrees.

In some embodiments, prior to insertion into the patient's urinary tract, the portion of the drainage channel proximal to the retention portion defines a straight or curved central axis, and when deployed, the coils of the retention portion extend about a central axis 190 of the retention portion 154 that is at least partially coextensive or coextensive with the straight or curved central axis 192 of the portion of the flow channel 122.

In some embodiments, multiple coils 156 can have the same inner and/or outer diameter D and height H. In that case, the outer diameters 162, 166, 169 of the coils 156 can range from about 10 mm to about 30 mm. The height H2 between the centerlines of each coil 156 can range from about 3 mm to about 10 mm.

In some embodiments, the retention portion 154 is configured to be inserted into a tapered portion of the renal pelvis. For example, the outer diameter D of the coil 156 may increase toward the distal end 152 of the inlet line 146, resulting in a helical structure having a tapered or partially tapered configuration. For example, the distal or maximum outer diameter 169 of the tapered helical portion ranges from about 10 mm to about 30 mm, corresponding to the dimensions of the renal pelvis.

In some embodiments, the outer diameters 162, 166, 169 and/or height H2 of the coils 156 may vary in a regular or irregular manner. For example, the outer diameters 162, 166, 169 of the coils, or the height H2 between the coils, may increase or decrease by a regular amount (e.g., about 10% to about 25%) between adjacent coils 156. For example, for a retention portion 154 having three coils (e.g., as shown in FIG. 6), the outer diameter 162 of the proximal-most or first coil 160 may range from about 6 mm to about 18 mm, the outer diameter 166 of the middle or second coil 164 may range from about 8 mm to about 24 mm, and the outer diameter 169 of the distal-most or third coil 168 may range from about 10 mm to about 30 mm.

Other non-limiting examples of suitable retention portions, such as funnel-shaped structures, inflatable or balloon structures, porous and/or sponge-like structures, and expandable cage structures, are disclosed in U.S. Patent Nos. 10,307,564 and 9,744,331, and PCT Publication No. WO 2017/015345, which are incorporated herein by reference. Some examples of suitable catheters, systems, and methods of use are also disclosed in U.S. Patent Application Publication No. 2017/0348507, which is incorporated herein by reference in its entirety.

Optionally, the retention portion 154 can further comprise one or more perforations or drain holes 147. The perforations or drain holes 147 can be configured to draw fluid into the interior of the inlet line 146, for example, located on or adjacent to the retention portion 154, on or through a sidewall of the inlet line 146, to allow urinary waste to flow from outside the inlet line 146 to the interior of the flow channel 122. The drain holes 147 can be positioned in a spaced array along the sidewall of the inlet line 146. In some embodiments, the retention portion 154 can further comprise additional holes at the distal end 152 of the retention portion 154.

The drain hole 147 can be located, for example, near the open distal end 152 of the inlet line 146. In other embodiments, the perforated section and/or the drain hole 147 are located along the sidewall 185 of the distal portion of the inlet line 146. The drain hole 147 can be used to assist with fluid collection. In other embodiments, the retention portion 154 is dedicated to retention and fluid collection, and/or application of negative pressure is provided by structure elsewhere on the inlet line 146.

In some embodiments, the retention portion 154 of the inlet line 146 comprises a sidewall 185 having a radially inward-facing side 186 and a radially outward-facing side 187. In such cases, the total area of the perforations or holes 147 on the radially inward-facing side 186 may exceed the total area of the perforations or holes 147 on the radially outward-facing side 187. The radially outward-facing side 187 may be essentially free of, or absent from, perforations.

The drain holes 147 can be any shape and arranged in any suitable configuration to allow fluid F1 to pass through the drain holes 147 and into the lumen of the inlet line 146. For example, the drain holes 147 can be circular or non-circular (e.g., oval, square, rectangular, polygonal, irregular), or any combination thereof. The location and size of the drain holes 147 can vary depending on the desired flow rate and configuration of the retention portion 154. For circular drain holes 147, the diameter of each of the drain holes 147 can range from about 0.05 mm to 1.1 mm, from about 0.7 mm to about 0.9 mm. The cross-sectional area of each drain hole 147 may range ^{from about 0.002 mm to} about 1.0 mm, or from about 0.35 ^mm to about 0.65 ^mm . The distance between adjacent discharge holes 147, e.g., the linear distance between the center points of adjacent discharge holes 147 when the coil is straightened, can range from about 20 mm to about 25 mm, or from about 21 mm to about 23 mm. The discharge holes 147 can be spaced in any arrangement, e.g., linear or offset. The total cross-sectional area of all of the discharge holes 147 on the retention portion 154 can range ^from about 0.002 ^mm to about ¹⁰ cm, about 0.02 ^mm to about 8 cm, or about 0.2 ^mm to about ⁵ cm. In some examples, the non-circular discharge holes 147 have a cross-sectional area of about 0.00002 ^mm to about 1.0 ^mm , or about 0.02 ^mm to about 0.8 ^mm .

In some embodiments, the drain holes 147 are located around the entire circumference of the sidewall 185 of the inlet line 146 to increase the amount of fluid that can be drawn into the flow channel 122. In other embodiments, the drain holes 147 can be located essentially only on the radially inward-facing side 186 of the coil 156 to prevent blockage or obstruction of the drain holes 147, and the outward-facing side 187 of the coil can be essentially free of drain holes 147. For example, when negative pressure is induced within the ureter and/or renal pelvis, ureteral and/or renal mucosal tissue can be drawn against the retention portion 154 and block some of the drain holes 147 on the outer periphery of the retention portion 154. Drain holes 147 located on the radially inward side of the retention structure will not be significantly blocked when such tissue contacts the outer periphery of the retention portion 154. Furthermore, the risk of tissue injury from entrapment or contact with the drain holes 147 can be reduced or ameliorated.

In some embodiments, the retention portion 154 can include one or more mechanical stimulation devices for providing stimulation to nerve and muscle fibers within the adjacent tissue of the ureter and renal pelvis. For example, the mechanical stimulation device can include a linear or annular actuator embedded in or mounted adjacent to a portion of the sidewall 185 of the inlet line 146 and configured to emit low-level vibrations. In some embodiments, mechanical stimulation can be provided to a portion of the ureter and/or renal pelvis to complement or modify the therapeutic effects achieved by the application of negative pressure. While not intending to be bound by theory, such stimulation is believed to affect the adjacent tissue, for example, by stimulating nerves and/or activating peristaltic muscles associated with the ureter and/or renal pelvis. Nerve stimulation and muscle activation can result in changes in pressure gradients or pressure levels within the surrounding tissue and organ, which can contribute to, or in some cases enhance, the therapeutic benefits of negative pressure therapy.

In some embodiments, pump 110 further comprises an outlet line 158 extending from pump 110 to portion 2 of the patient's urinary tract. Outlet line 158 can be formed from similar materials and have similar dimensions to inlet line 146. Outlet line 158 may extend from the bladder through the urinary sphincter and urethra to a collection container outside the body. In some embodiments, the length of outlet line 158 may range from about 30 cm to about 120 cm, depending on the patient's gender and age.
(Negative Pressure Therapy System)

Referring now to FIG. 12, pump assembly 100 may be a component of a negative pressure therapy or treatment system 300 for providing negative pressure therapy to a patient. System 300 includes pump assembly 100 in communication with one or more computing devices positioned outside the patient's body for controlling operation of pump assembly 100 and for receiving, processing, and analyzing data generated by the indwelling components of pump assembly 100.

In some embodiments, as shown in FIG. 12 , the system 300 includes a remote control device 310 in wired or wireless communication with the controller 112 of the pump assembly 100. The remote control device 310 may be a dedicated electronic device configured to communicate with the pump assembly 100. In other embodiments, the remote control device 310 includes a general-purpose computing device configured to execute software for communicating with and/or controlling the operation of the pump assembly 100. For example, the remote control device 310 may be a handheld web-enabled computing device such as a smartphone, computing tablet, or personal digital assistant. In other embodiments, the remote control device 310 may include a laptop computer, desktop computer, or computer server, as known in the art. The remote control device 310 may be located in close proximity to the patient. For example, as described above, the remote control device 310 may be a portable device configured to be easily stored in a pocket, waist bag, holster, or harness worn by the patient, positioning the remote control device 310 as close to the pump assembly 100 as possible. In other examples, the remote control device 310 may comprise a stationary electronic device, for example located in the patient's home or hospital room, configured to communicate with the pump assembly 100 via a short-range data communication protocol such as BLUETOOTH® or a long-range data communication protocol such as WiFi.

In some embodiments, the remote control device 310 includes a controller 312, a communication interface 314 configured to communicate with the pump assembly 100 and other remote computer devices or networks, and, optionally, an electromagnetic field generator 316 configured to generate an electromagnetic field and generate power in the induction coil 210.

In some examples, remote control device 310 further includes a feedback and/or user interface module 318 operably connected to a feedback device, such as a visual display 320. Feedback and/or user interface module 318 can be configured to receive information generated by one or more sensors 230, 232 associated with pump 110 and to provide feedback to a user about the operating conditions of pump assembly 100 and/or about the physiological condition of the patient. For example, feedback and/or user interface module 318 may be configured to cause visual display 320 to display information about the volume and/or flow rate of urine passing through flow channel 122 or about the amount of negative pressure being generated by pump 110. In other examples, the displayed information can also include information about pump assembly 100, such as the remaining charge in battery 226 or the estimated time until battery 226 will need to be recharged.
In some examples, information about the treatment protocol for the patient may also be displayed, for example, information about the length of time negative pressure will continue to be delivered to the patient or information indicating the pattern of positive and negative pressure to be delivered to the patient.

In some examples, the communication interface 314 includes a short-range data transceiver 322 configured to communicate with the communication interface 314 of the controller 112. For example, the short-range data transceiver 322 can include a Bluetooth® transceiver, a near-field communication (e.g., RFID) transceiver, or a similar data transmission device. Because the remote control device 310 is configured to be positioned as close to the pump assembly 100 as possible, the transmission range of the short-range data transceiver 322 need be only a few feet or less. In some examples, the communication interface 314 further includes a long-range data transceiver 324 for transmitting information collected by the pump assembly 100 and the remote control device 310 to a remote source, such as a computer network 326, a database 328, or a web-based portal or website 330. For example, information about the patient and/or about the treatment provided by the pump assembly 100 can be transmitted from the remote control device 310 to the remote database 328 for inclusion in the patient's electronic health record. A confirmation that treatment has been provided may also be transmitted to a medical professional, such as an attending physician, who may be able to review the confirmation along with physiological information about the patient, for example, using the web-based portal 330.
(Deployment)

The pump assembly 100, battery 226, and/or induction coil 210 are configured to be inserted through the patient's urethra into the bladder, ureter, and/or renal pelvis. To facilitate this placement and deployment, the pump assembly 100 described herein is configured to fit within a deployment device, such as a catheter tube, and to automatically transition to a deployed position once advanced from the tube. In some configurations, the entire assembly 100, particularly the pump 110, controller 112, and induction coil 210, can be delivered through the urethra into the ureter and bladder using, for example, a 12-16 Fr catheter (outer diameter 4.0-5.3 mm). In other examples, portions of the pump assembly 100 can be delivered through an abdominal incision or a percutaneous nephrostomy or urostomy procedure.

13A and 13B, an exemplary deployment catheter 410 for use with the pump assembly 100 includes a flexible elongate tube 412 having an open distal end 414 configured to be inserted into the urinary tract through the urethra, a proximal end 416 that may be configured to remain outside the patient's body, and a sidewall 418 extending therebetween, such as a substantially continuous sidewall formed from a flexible medical-grade plastic material. For example, the elongate tube 412 can be formed from one or more biocompatible polymers, such as polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone-coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate). A portion of the elongated tube 412 can also be made of and/or impregnated with a metallic material, such as copper, silver, gold, nickel-titanium alloy, stainless steel, and/or titanium. At least a portion or all of the catheter 410, such as the tube 412, can be coated with a hydrophilic coating to facilitate insertion and/or removal and/or to improve comfort. In some embodiments, the coating comprises a hydrophobic and/or lubricious coating. For example, a suitable coating can comprise ComfortCoat® hydrophilic coating produced by Koninklijke DSM N.V., or a hydrophilic coating comprised of a polyelectrolyte, such as disclosed in U.S. Pat. No. 8,512,795 (incorporated herein by reference).

In some embodiments, the proximal end 416 of the tube 412 can include a hub (not shown) with a guidewire lumen port to assist the user in positioning the catheter 410 through the urethra and into the bladder and/or ureter. The catheter 410 can be a standard deployment catheter formed from one or more biocompatible polymers, such as polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone-coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate). As in the previous embodiment, portions of the catheter 410 can also be made of and/or impregnated with metallic materials, such as copper, silver, gold, nickel-titanium alloy, stainless steel, and/or titanium. The extension tube 412 can be any standard size for insertion within the urinary tract, such as a 12Fr to 16Fr tube. The length of the extension tube 412 may range from approximately 30 cm to approximately 120 cm, depending on the patient's gender and age.

As shown in FIGS. 13A and 13B, the pump assembly 100, including the pump 110, controller 112, and induction coil 210, is configured to be positioned within the tube 412 in a retracted configuration and position. The pump assembly 100 is advanced through the tube 412 by the pusher rod 420, as shown in FIG. 13B. Once the open distal end 414 of the catheter 410 has been advanced through the urinary tract to a desired location within the bladder, ureter, or kidney, the user may advance the pusher rod 420 through the extension tube 412, causing the components of the pump assembly 100 to exit the tube 412 through its open distal end 414. Once the tube 412 is removed, the pump 110 and controller 112 structures may be deployed from the retracted configuration or position to a deployed configuration or position. For example, radially extending barbs 140 (shown in FIG. 4 ) may extend radially outward from the sidewall 120 of the pump 110 to contact the interior ureteral wall and maintain the positioning of the pump 110 within the ureter. In a similar manner, once the induction coil 210 extends beyond the open distal end 414 of the extension tube 412, it may unwind in the manner described above. In some embodiments, the induction coil 210 may be biased to its unwound state. In that case, the induction coil 210 may automatically unwind upon removal from the extension tube 412. In other embodiments, the user may manually unwind the induction coil 210 by actuating a release button or trigger wire.

To deploy the pump assembly 100 within a patient's urinary tract, a medical professional may first advance a guidewire to a desired location within the bladder and/or ureter. In some cases, a visualization device, such as a cystoscope, may be used to obtain visualization of the bladder and ureteral orifices and assist in positioning the distal end of the guidewire. A delivery catheter 410 can be delivered over the guidewire. For example, a medical professional may insert the delivery catheter 410 over the guidewire and advance the distal end 414 of the catheter 410 over the guidewire toward the ureteral orifices 24, 26. Once the distal end 414 of the catheter 410 is in position, the medical professional can begin pushing the pump assembly 100 from the deployment extension tube 412 by advancing the pusher rod 420 through the extension tube 412. As the extension tube 412 is discharged, the open distal end 118 of the pump 110 is advanced through the ureteral orifices 24, 26 and into the distal ends 9 of the patient's ureters 8, 10. The controller 112 and induction coil 210 can remain within the bladder.

In some embodiments, as discussed above, the housings 114, 128 of the pump 110 and/or controller 112 can include retractable or permanently extending barbs 140, 144 for mounting the pump 110 and/or controller 112 to the surface of the ureter, renal pelvis, bladder, or urethra. In some embodiments, once the pump assembly 100, including the pump 110 and controller 112, is in position within the patient's urinary tract, the user may activate a release mechanism, causing the barbs 140, 144 to extend toward the inner wall of the ureter, renal pelvis, bladder, or urethra. In other embodiments, the barbs 140, 144 may automatically extend as the extension tube 412 is retracted. Retraction of the extension tube 412 also causes the deployable induction coil 210 to unwind from the coiled configuration to a generally flat configuration.
Bladder Pump Assembly

According to another aspect of the present disclosure, systems and devices can be configured for inducing negative pressure within the bladder. An example of a bladder pump assembly, generally identified as assembly 500, including a bladder pump 510 for inducing negative pressure within the bladder is illustrated in FIG. 14. While not intending to be bound by theory, it is believed that the negative pressure induced within the bladder also acts on the ureters and kidneys, thereby drawing urine from the kidneys and transmitting it through the bladder and ureteral orifices, achieving therapeutic results similar to the exemplary assemblies described above. As discussed above, negative pressure applied to the kidneys is believed to improve urine production and provide physiological benefits such as reduced venous congestion or reduced risk of acute kidney injury.

With reference to FIG. 14, the bladder pump 510 can be substantially similar to the pumps described above and can include, for example, an impeller or piezoelectric configuration as shown in FIGS. 7 and 8. In some embodiments, the bladder pump 510 includes an annular housing 512 sized for placement within the patient's bladder. For example, the bladder pump 510 can be placed adjacent the urethral opening or sphincter 20 such that the sphincter 20 forms a seal about the outer circumference 514 of the housing 512 to prevent fluid from leaking from the bladder 12.

In some embodiments, the bladder pump 510 includes fluid entry holes or ports 532 extending through the sidewall 534 of the pump 510 for drawing fluid into the central channel 513 of the pump 510. In some embodiments, the diameter of each of the drain holes or ports 532 is about 0.5 mm to 2.0 mm, or about 0.75 mm to 1.0 mm. The distance between adjacent drain holes or ports 532 about the circumference of the sidewall 534 can be about 5 mm to about 30 mm, or about 10 mm to 20 mm. The holes or ports 532 can be of a size and shape suitable for drawing fluid from the bladder 12 into the bladder pump 510. For example, the holes or ports 532 can be circular, non-circular (e.g., oval, square, rectangular, polygonal, and/or irregular), or a combination thereof. In some embodiments, the holes or ports 532 can be covered with a screen or filter to prevent solid material from being drawn into the bladder pump 510.

Assembly 500 further includes a bladder wall support 516 extending from bladder pump 510. Bladder wall support 516 is configured to prevent upper portion 15a (not shown in FIG. 14) of bladder wall 15 from collapsing when negative pressure is applied by bladder pump 510 to bladder 12, ureters 8, 10, and kidneys 4, 6. In particular, bladder wall support 516 maintains at least upper portion 15a of bladder 12 in an uncollapsed state in which ureteral orifices 24, 26 are not obstructed by collapsed bladder wall 15. An exemplary bladder wall support that may be used in a negative pressure therapy system for providing negative pressure to portions of the urinary tract, such as the bladder, ureters, and kidneys, is described in PCT Publication No. WO 2017/015345, entitled "Catheter Device and Method for Inducing Negative Pressure in a Patient's Bladder," the contents of which are incorporated herein by reference in their entirety.

In some embodiments, the bladder wall support 516 comprises an inflatable balloon 518 configured to expand from a collapsed state to an expanded state. The balloon 518 is configured to isolate the trigone region 22 of the bladder 12 from the upper bladder wall 15a, thereby preventing the upper bladder wall 15a from collapsing into the trigone region 22 when negative pressure is applied thereto. In some embodiments, the balloon 518 can be approximately 1.0 cm to 2.3 cm in diameter, preferably approximately 1.9 cm (0.75 inches) in diameter. The balloon 518 is preferably formed from a flexible material, such as, for example, a biocompatible polymer, polyvinyl chloride, polytetrafluoroethylene (PTFE) (e.g., Teflon®), silicone-coated latex, or silicone.

14, in some embodiments, the balloon 518 has a generally flattened or elongated cross-section with a maximum inflated width L1. The inflated width L1 can be, for example, about 15 cm or less, or about 10 cm or less. The inflated width L1 generally exceeds the maximum inflated height L2 of the balloon 518. The maximum inflated height L2 can be about 5 cm or less, or about 2.5 cm or less. The width L1 generally corresponds to the width of the patient's bladder. In some embodiments, the bottom or proximal surface 520 of the balloon 518 is concave, offset from the proximal surface of the bladder by about 1 cm to about 3 cm to allow free flow of urine from the ureteral orifice 24.

The pump assembly 500 further includes a drainage catheter 522 comprising an elongate tubular member 524. Similar to the other catheters and tubular members described herein configured for insertion within the urinary system, the tubular member 524 of the drainage catheter 522 can be formed from any suitable flexible material, such as one or more biocompatible polymers, such as polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone-coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate). As in the previous example, a portion of the tubular member 524 can also be comprised of and/or impregnated with a metallic material, such as copper, silver, gold, nickel-titanium alloy, stainless steel, and/or titanium. In some embodiments, at least a portion or all of tubular member 524 can be coated with a hydrophilic coating to facilitate insertion and/or removal and/or to improve comfort. In some embodiments, the coating comprises a hydrophobic and/or lubricious coating. For example, a suitable coating can comprise a ComfortCoat® hydrophilic coating.

In some embodiments, the elongate tubular member 524 extends from the proximal end 511 of the bladder pump 510 through the urethra 18 to the outside of the patient's body. The drainage catheter 522 may be connected to a fluid collection container, such as a urine collection bag or pouch (not shown). The drainage catheter 522 may be a single or multi-lumen catheter with one or more drainage lumens 526 in fluid communication with the channel 513 of the bladder pump 510. In some embodiments, the drainage catheter 522 further comprises an inflation lumen 528 in fluid communication with the interior 530 of the inflatable balloon 518. As shown in FIG. 14 , in some embodiments, the inflation lumen 528 extends through the bladder pump 510 and into the interior 530 of the balloon 518. The inflation lumen 528 is used to deliver a filler material, such as saline, to inflate the balloon 518. When the user is prepared to remove the pump assembly 500 from the body, the balloon 518 can be deflated by emptying the filler material, such as saline, contained within the balloon interior 520 out of the body through the inflation lumen 528.

In some embodiments, the inflation lumen 528 extends through the exhaust lumen 526, as shown in FIG. 14 . For example, the inflation lumen 528 may extend through the exhaust lumen 526 such that the central longitudinal axis X1 of the exhaust lumen 526 is generally coextensive with the central longitudinal axis of the inflation lumen 528. However, many different arrangements of the exhaust lumen 526 and inflation lumens 528 may be used within the scope of the present disclosure. For example, separate exhaust lumens 526 and inflation lumens 528 may extend through the exhaust catheter 522 in a side-by-side configuration. Other configurations of the exhaust lumen 526 and inflation lumens 528 will also be apparent to those skilled in the art.

In use, bladder pump assembly 500, including bladder pump 510, bladder wall support 516, and elongated tubular member 524, is advanced through urethra 18 into bladder 12. Balloon 518 of bladder wall support 516 is then expanded within bladder 12, as shown in FIG. 14 . Once elongated member 524 and bladder pump 510 are in place, urinary sphincter 20 can be allowed to seal or partially seal around outer circumference 514 of bladder pump 510. Once balloon 518 and bladder pump 510 are positioned within bladder 12, the user may actuate the pumping element of bladder pump 510 to draw urine from bladder 12 through fluid entry port 532 and into bladder pump 510. The negative pressure generated by bladder pump 510 also acts on more distal portions of the urinary tract. For example, the ureters and kidneys can be exposed to negative pressure to increase renal perfusion in the manner described herein. When bladder pump 510 is actuated, fluid is drawn through channel 513 of bladder pump 510 due to movement of the pumping elements and drains from bladder pump 510 into drain lumen 526 of drainage catheter 522. Collected fluid drains from the body through drainage catheter 522 where it is collected in a fluid collection container, such as a bag or pouch, located outside the patient's body. Collected urine can be analyzed to monitor patient physiological conditions and to verify that pump assembly 510 is operating and providing negative pressure in an expected manner. Bladder pump 510 can further include sensors 230, 232 configured to detect characteristics of urine passing through bladder pump 510 and monitor pump performance and/or the patient's physiological condition.
(Implantable pump system)

With reference to Figures 15A-16C, according to another aspect of the present disclosure, an implantable pump assembly or pump system 600 is provided that includes a pump 612 configured to be positioned within a patient's body but outside the urinary tract. As in the previous example, the implantable pump system 600 is configured to provide or induce negative pressure within the patient's renal pelvis and/or kidney.

Unlike the previous embodiment, the pump 612 and electrical components of the pump system 600 are not positioned within the urinary tract. Instead, as shown in FIGS. 15A and 16A , the pump 612 of the pump system 600 is positioned outside the urinary tract within the patient's abdominal cavity or peritoneum. As used herein, "peritoneal cavity" may refer to the cavity within the abdomen, comprising the space between the abdominal wall and the spine. The abdominal cavity contains organs, including the lower part of the esophagus, stomach, small intestine, colon, rectum, liver, gallbladder, pancreas, spleen, kidneys, and urinary bladder. "Peritoneum" refers to the tissue or membrane that lines the abdominal cavity and/or coats the organs within the abdominal cavity. In other embodiments, the pump 612 may be positioned subcutaneously or in other suitable locations adjacent to the patient's pelvis and/or urinary system. For example, the pump 612 may be implanted in the space between the bottom layer of skin and the patient's ribs.

Generally, the pump system 600 includes a ureteral catheter 614, similar to the ureteral catheters and fluid inlet lines described above, for collecting fluid (e.g., urine) within the renal pelvis or kidney and conducting the fluid through the ureter to the pump 612. The pump system 600 may further include an outflow conduit or catheter 616 in fluid communication with the pump 612 for conducting the collected fluid from the pump 612 into the bladder, where it may eventually drain from the body through the urethra. The outlet catheter 616 may also extend to an external collection container for draining the fluid from the patient's body, for example, through the patient's bladder and urethra. As shown in FIGS. 15A and 16A , unlike the previous embodiment, in which the entire assembly or substantially the entire assembly was positioned within the urinary tract 2, the catheters 614, 616 exit the urinary tract by passing through one or more incisions in the bladder wall. As described herein, various arrangements of multi-lumen and/or coaxial catheter segments and/or tubular shunts can be provided to minimize the number of incisions in the bladder wall made during implantation of the pump system 600 within a patient's body. For example, the catheters 614, 616 can be separate tubes that pass through the bladder wall via a single tubular shunt. Alternatively, the catheters 614, 616 can be provided in a multi-lumen arrangement in which the tube of one catheter (e.g., the inflow catheter 614) is fully or partially enclosed within the tube of a second catheter (e.g., the outflow catheter 616) so that only one incision in the bladder wall is required.

As described herein and shown in FIGS. 15A-15D, in some embodiments, the pump system 600 is configured to be at least partially or fully implanted within the body and can be recharged, e.g., using a wired or wireless charging assembly. As used herein, a pump system is "fully implanted" when all or substantially all of the processing and control components of the pump system 600 are provided within the pump 612, which is implanted within the body. In such cases, the pump 612 may periodically receive power from an external source (e.g., to recharge a battery) but otherwise operate independently. In other embodiments, as shown in FIGS. 16A-16C, portions of the pump system 600, such as the control circuitry and/or power supply, may be located within a separate external or remote device located outside the body. The external or remote device may communicate wired or wirelessly with the implanted portion of the pump system 600. For example, the pump 612 may receive power from an external power supply via a shielded percutaneous wire 670 (shown in FIGS. 16A-16D) extending between the pump 612 and a remote device. By using a separate power supply, the size of the pump 612 can be minimized because no battery or other power supply circuitry is included in the pump 612, which is implanted within the body.

The ureteral catheter 614 may be similar in shape and size to any of the exemplary ureteral catheters previously described. As in the previous examples, the ureteral catheter 614 includes a drainage lumen 618 for conducting urine from the kidney and/or renal pelvis to the pump 612. In some examples, the pump system 600 includes ureteral catheters 614 deployed in both kidneys and/or renal pelvis that are connected to the same pump 612 to provide simultaneous negative pressure therapy for both kidneys. When both kidneys are treated simultaneously, in some examples, the ureteral catheters 614 deployed in each kidney may be joined together within the bladder, with a single inflow catheter or tube extending from the bladder to the pump 612 through a single incision in the bladder wall. In other examples, the ureteral catheters 614 may remain as separate tubes that may pass to the pump 612, for example, through a tubular shunt in the bladder wall. A wide variety of ureteral catheter designs can be used in conjunction with the pump system 600 disclosed herein, such as the ureteral catheter embodiments disclosed in U.S. Patent Application Publication No. 2019/0091442 to Erbey et al., entitled "Coated Ureteral Catheter or Ureteral Stent and Method" (hereinafter "the '442 Publication"), and U.S. Patent Application Publication No. 2020/0094017 to Erbey et al., entitled "Coated Ureteral Catheter or Ureteral Stent and Method" (hereinafter "the '017 Publication"), which are incorporated herein by reference in their entireties.

In some embodiments, the drainage lumen 618 of the ureteral catheter 614 includes a first end 620 (elsewhere referred to as the proximal end) configured to connect to the pump 612 and a second end 622 (elsewhere referred to as the distal end). The second end 622 is configured to be positioned within or near the renal pelvis and/or kidney. The catheter 614 further includes a tubular sidewall extending between the first end 620 and the second end 622, defining the lumen 618. The catheter 614 may be any size suitable for deployment within the ureter. For example, the catheter 614 may be from about 1 Fr to about 9 Fr (French catheter scale). In some embodiments, the tubular portion of the catheter 614 has an outer diameter ranging from about 0.33 mm to about 3 mm. In one embodiment, the catheter 614 is 6 Fr and has an outer diameter of 2.0±0.1 mm. In some embodiments, the inner diameter of the ureteral catheter 614 can range from about 0.165 mm to about 2.39 mm, or from about 1.0 mm to 2 mm, or from about 1.25 mm to about 1.75 mm. As discussed above, portions of the ureteral catheter 614 can be formed from one or more suitable biocompatible materials, such as materials used for conventional urinary stents and catheters. Exemplary materials can be comprised of one or more biocompatible polymers, such as polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone-coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate). As in the previous embodiment, portions of the catheter 614 can also be comprised of and/or impregnated with metallic materials, such as copper, silver, gold, nickel-titanium alloy, stainless steel, and/or titanium.

The ureteral catheter 614 may further include a retention portion 624, such as any of the retention portions described above, extending radially outward from a portion of the second end 622 of the drain lumen 618. The retention portion 624 may be configured to extend to a deployed position in which the diameter of the retention portion 624 exceeds the diameter of the drain lumen 618. In some examples, the retention portion 624 includes at least one drain port 626 to allow fluid flow into the drain lumen 618. In some examples, the at least one drain port 626 includes perforations on an inward-facing side of the retention portion 624 positioned to receive urine produced by the kidney. The drain port 626 may be a protected drain port positioned on a protected surface area of the retention portion 624, meaning that the protected drain port 626 is not blocked by mucosal tissue that is drawn against the retention portion 624 by the negative pressure when negative pressure is applied to the kidney and/or renal pelvis. As in the previous example, the perforations on the retention portion 624 may be about 0.05 mm to about 1.1 mm in diameter, or preferably about 0.7 mm to about 0.9 mm in diameter. The cross-sectional area of each perforation may range ^from about 0.002 mm to about 1.0 ^mm or ^from about 0.35 mm to about 0.65 ^mm .

A wide variety of retention portions 624 can be used to maintain the second end 622 of the ureteral catheter 614 within the renal pelvis or kidney, as described, for example, in the '442 and '017 publications. In some embodiments, as shown in FIGS. 15A and 16A, the retention portion 624 comprises a helical coil, similar in shape and function to the helical coil shown in FIG. 6. As in the previous embodiment, the helical coil of the retention portion 624 can be formed, for example, by bending or twisting the second end 622 of the catheter 614 in a coiled configuration. The coiled retention portion 624 can be tapered such that the coil near the end of the catheter 614 is wider than the coil located at the base of the retention portion 624. This tapered configuration can be selected to correspond to the shape of the renal pelvis. The coiled retention portion 624 can define an inward-facing portion or side and an outward-facing portion or side of the catheter tube. In some embodiments, the exhaust port 626 or perforations are positioned on the inward-facing side of the coil to protect the exhaust port or perforations from being blocked by tissue drawn toward the retention portion as negative pressure is applied through the exhaust lumen 618 of the ureteral catheter 614. In that case, the outward-facing portion of the coil may be free of perforations or openings.

The pump system 600 further includes an outflow catheter 616 extending from the pump 612 to a drainage location for draining collected fluid (e.g., urine) from the body. For example, the outflow catheter 616 may be an elongated tube or conduit connected to the pump 612 at a first end 632, also referred to as the proximal end. A second end 634, also referred to as the distal end, of the outflow catheter 616 can be positioned within the patient's bladder. Urine collected by the ureteral catheter 614 can then pass through the outflow catheter 616 to the bladder. Urine released into the bladder can necessarily pass from the body through the urethra.

The outflow catheter 616 may be similar in material composition and dimensions to the ureteral catheter 614. For example, the outflow catheter 616 can be made from a material similar to the ureteral catheter 614, such as one or more biocompatible polymers, such as polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone-coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate). The length of the outflow catheter 616 is generally based on the positioning of the pump 612. The outflow catheter 616 is desirably long enough to extend from the patient's bladder through an incision in the bladder wall to the pump 612. If the inflow or ureteral catheter 614 and outflow catheter 616 remain separate along their entire lengths, the outflow catheter 616 may be the same width or diameter as the inflow or ureteral catheter 614. For example, the outflow catheter 616 may be about 1 Fr to about 9 Fr (French catheter scale). In some embodiments, the outflow catheter 616 can have an outer diameter ranging from about 0.33 to about 3.0 mm. In one embodiment, the outflow catheter 616 is 6 Fr and has an outer or external diameter of 2.0±0.1 mm. In some embodiments, the inner diameter of the outflow catheter 616 can range from about 0.165 mm to about 2.39 mm, or from about 1.0 mm to 2 mm, or from about 1.25 mm to about 1.75 mm.

As described in further detail herein, in some embodiments, a portion of the inflow or ureteral catheter 614 can be partially or completely enclosed within the lumen of the outflow catheter 616, forming a multi-lumen catheter along at least a portion of the length of the inflow or ureteral catheter 614. In that case, the outflow catheter 616 is wide enough to enclose the inflow or ureteral catheter 614. For example, the multi-lumen portion of the outflow catheter 616 may have an outer diameter of about 0.5 mm to about 5.0 mm, or about 2.0 mm to 4.0 mm. In some embodiments, the inner diameter of the outflow catheter 616 can range from 0.33 mm to about 4.4 mm, or about 1.5 mm to about 3.5 mm. In some embodiments, as discussed above, the pump system 600 includes two ureteral catheters 614, one deployed within each renal pelvis and/or kidney of the patient. In that case, both ureteral catheters 616 may be enclosed within the outflow catheter 616 to reduce the number of incisions in the bladder wall.

The pump system 600 further includes a pump 612 configured to be implanted in the body. The pump 612 is configured to provide or exert a negative pressure on a portion of the urinary tract through an outlet lumen 618 of a ureteral catheter 614. For example, when activated, the pump 612 can exert a negative pressure on the renal pelvis and kidney, drawing urine produced by the kidney into the outlet lumen 618. In some embodiments, the pump 612 is configured to provide a negative pressure of about 0 mmHg to about 150 mmHg, as measured at a first end 620 of the outlet lumen 618 of the ureteral catheter 614. Desirably, the negative pressure provided by the pump 612 can be sufficient to establish a pressure gradient across the filtering anatomy, or glomerulus, of the patient's kidney, promoting urine flow toward the ureter.

In some embodiments, the pump 612 includes a housing 628 and a fluid port 630 extending through the housing 628. As with the previously discussed embodiments, the housing 628 can be formed from any suitable biocompatible material that will not degrade when positioned within the body. Materials used for implantable cardiac devices, such as implantable cardioverter-defibrillators and/or pacemakers, can be used for the housing 628. For example, the housing 628 can be formed from a stamped metal, such as stainless steel or a titanium alloy. Alternatively, or in addition, the housing 628 may be made from a biocompatible rigid plastic, as is known in the art. Unlike previous embodiments in which the housing was sized for insertion within the urinary tract, the housing 628 is desirably sized and shaped to be positioned within a body cavity, such as the abdominal cavity, or within a subcutaneous space between the skin and ribs or muscle tissue. The housing 628 can include rounded edges and/or curved surfaces, as hard edges and corners may irritate body tissue. In some examples, as shown in FIG. 15A, housing 628 comprises a narrow, box-shaped structure having a height H1, a width W1, and a shallower depth or thickness T1. In some examples, height H1 and width W1 may each be from about 25 mm to about 75 mm. Thickness T1 may be from about 5 mm to about 10 mm. In other examples, housing 628 may be a generally disc-shaped structure having opposing flat or generally flat front and rear sides connected by a curved or rounded edge. The diameter of the disc-shaped housing may be from about 25 mm to about 75 mm, and the thickness of the disc-shaped housing may be from about 5 mm to 10 mm.

As described in further detail herein, in some embodiments, the bodily implanted pump 612 is sized and shaped to be inserted into a subcutaneous cavity or body cavity through an incision. The housing 628 can be sized to be secured within the subcutaneous cavity or body cavity by suturing portions of the housing 628 to body tissue using conventional suturing techniques, as known in the art. As will be understood by those skilled in the art, conventional techniques for the insertion and deployment of electronic implantable devices, such as implantable cardioverter-defibrillators and pacemakers, can be used to implant a pump 612 within the scope of the present disclosure.

The fluid ports 630 of the pump 612 are configured to connect to the ends 620, 632 of the ureteral catheter 614 and the outflow catheter 616, thereby establishing fluid communication between the lumens 618 of the ureteral catheter 614 and the outflow catheter 616 and the pump components of the pump 612. The fluid ports 630 are sized to engage the ends 620, 632 of the ureteral catheter 614 and the outflow catheter 616 and, therefore, can have a diameter slightly larger than the outer diameter of the ureteral catheter 614 and/or the outflow catheter 616. In some embodiments, the pump 612 includes both an inflow fluid port for the ureteral catheter 614 and a separate outflow fluid port 630 for the outflow catheter 616. In other embodiments, as shown in FIGS. 15A-16D , the pump 612 includes a single fluid port 630 that is sized to receive the ends 620, 632 of both the ureteral catheter 614 and the outflow catheter 616. For example, in a multi-lumen arrangement, the fluid port 630 can be sized to receive the outer outflow catheter 616, meaning that the fluid port 630 has a diameter slightly larger than the outer diameter of the outflow catheter 616. In such an embodiment, the fluid port 630 comprises an outer annular portion sized to engage the end 632 of the outflow catheter 616, and an inner portion, such as a nozzle or luer connector, enclosed by the outer portion and configured to engage the end 620 of the ureteral catheter 614. Including only a single fluid port 630 within the pump housing 628 simplifies the housing 628 construction and, in particular, reduces the number of ports that need to be sealed during implantation.
(mechanical and electrical components of the pump)

The mechanical and electronic components of pump 612 and/or pump system 600 will now be described in further detail. In some embodiments, as shown in FIGS. 15A-15D, some or all of the electrical components are located within the housing 628 of pump 612. In other embodiments, as shown in FIGS. 16A-16D, some electrical components of pump system 600 can be contained within separate devices that can be implanted or external to the body.

In some embodiments, the pump 612 comprises at least one pump chamber or pump element 640 connected to the fluid port 630 by a suitable conduit 642, such as flexible or rigid tubing, extending from the fluid port 630 through the housing 628 to the pump chamber or element 640. The pump chamber or element 640 can be at least partially positioned within the housing 628 and in fluid communication with the fluid port 630. The pump chamber or element 640 can be configured to draw fluid through the outlet lumen 618 of the urinary catheter 614 and into the pump chamber or element 640. The pump chamber or pump element 640 can comprise a rotary dynamic pump and/or a positive displacement pump. As used herein, "rotodynamic pump" refers to a pump mechanism configured to continuously impart kinetic energy to the pumped fluid via a rotary pump element. The rotary pump element can comprise an impeller, turbine, propeller, screw, gear vane, rotor, or combinations thereof. A "positive displacement pump" refers to a pump element that moves fluid by trapping a fixed amount of fluid within a space and then forcing the trapped fluid through a discharge conduit or pipe. The pump chamber or element 640 for a positive displacement pump can comprise, for example, a reciprocating diaphragm. In some embodiments, the pump element 640 comprises a piezoelectric diaphragm pump. In other embodiments, the pump element 640 of a positive displacement pump comprises a peristaltic pump element.

With specific reference to FIGS. 15A-15D, in some embodiments, the pump system 600 further includes a controller 644 integrated with the pump 612. The controller 644 includes processing circuitry operably connected to the pump element 640 of the pump 612 to control operation of the pump 612. For example, the controller 644 may include a computer processor 646 and a memory 648 that includes instructions for operating the pump 612 and delivering negative pressure therapy to the patient. In particular, the processor 646 and the memory 648 may be configured to operate the pump 612 by setting and/or adjusting operating parameters of the pump 612 in response to instructions stored on the memory 648 or received from an external source, such as a remote computing device 650 accessible via a computer network 652.

The processor 646 and memory 648 can also be configured to control the pump chambers or elements 640 based on feedback received from sensors associated with the pump system 600. The pump system 600 can include a variety of different types of sensors positioned at different locations to sense information about fluid flow through portions of the assembly 600, as well as information about the patient's condition. The sensors can be electrically connected to the controller 644 to provide the controller 644 with information about the pump 612, the patient's condition, and/or the negative pressure therapy treatment. In some examples, the system 600 includes a fluid sensor 654 positioned within the fluid conduit 642 or catheters 614, 616. The fluid sensor 654 can be configured to measure a property or parameter of the fluid passing through the conduit 642 and/or catheters 614, 616. An example of a fluid property or parameter that can be used to control the pump element 640 can include fluid pressure or flow rate measured within the conduit 642 or catheters 614, 616.

In some embodiments, the pump system 600 further includes a catheter probe or sensor 656 positioned near the retention portion 624 of the ureteral catheter 614 configured to measure fluid pressure within the renal pelvis and determine the magnitude of negative pressure applied to the renal pelvis. The probe or sensor 656 can be electrically connected to the controller 644 and processor 646 by a wired connection extending through the ureteral catheter 614 to the pump 612 and integrated controller 644 to provide feedback on the operation of the pump system 600.

In some embodiments, the pump system 600 further comprises a pressure sensor 658 positioned on an exterior surface of a component of the assembly to measure pressure in various portions of the patient's body. For example, the pressure sensor 658 may be positioned on the exterior surface of the housing 628 of the pump 612 for a pump positioned within the abdominal cavity or peritoneal tissue. The pressure sensor 658 may be configured to detect the patient's intraperitoneal pressure as negative pressure therapy is provided to the patient.

In some examples, the processor 646 and memory 648 are configured to receive and process information from the sensors 654, 656, 658 to determine parameters related to fluid flow and/or the patient's condition. For example, information from the fluid sensor 654 in the catheters 614, 616 and/or conduit 642 may be processed to determine the fluid flow rate through the ureteral catheter 614 and/or the volume of urine fluid drawn into the lumen 618 of the ureteral catheter 614. Information from the retention portion probe 656 located on the retention portion 624 of the ureteral catheter 614 may be used to determine the negative pressure provided to the kidney or renal pelvis. Information from the pressure sensor 658 on the housing 628 may be used to determine intra-abdominal pressure.

In some examples, the processor 646 and memory 648 of the controller 644 can be configured to control operating parameters of the pump 612 based on the determined fluid flow and patient parameters. For example, the processor 646 and memory 648 can be configured to adjust the pump 612 by reducing the power applied to the pump chamber or pump element 640 when the fluid flow rate through the ureteral catheter 614 or the magnitude of the negative pressure measured by the retention portion probe 656 is higher than an expected value or threshold, which may reduce the fluid flow rate or flow rate drawn into the drainage lumen 618 of the ureteral catheter 614. Similarly, the processor 646 and memory 648 can be configured to adjust the pump 612 by increasing the power to the pump chamber or pump element 640 when the fluid flow through the ureteral catheter 614 or the magnitude of the negative pressure measured at the renal pelvis by the retention portion probe 656 is lower than an expected value or below a minimum threshold, so as to increase the flow rate and/or flow rate.

In some examples, the operating parameters of the pump 612 can be determined based on measured physiological information about the patient, such as the patient's measured intra-abdominal pressure. It is believed that increased intra-abdominal pressure may indicate reduced renal function. To address the increased intra-abdominal pressure, the processor 646 and memory 648 can be configured to adjust the pump 612 by increasing power to the pump chamber or pump element 640 to increase the magnitude of the negative pressure applied to the renal pelvis and kidneys. As discussed above, increasing the magnitude of the negative pressure applied to the renal pelvis and/or kidneys is expected to increase urine output, which is expected to reduce venous stasis and pressure. The processor 646 and memory 648 can be configured to continue operating the pump chamber or pump element 640 at the increased power until the intra-abdominal pressure decreases, for example, below a target or threshold value.

In some embodiments, the pump 612 further comprises a power supply, such as a rechargeable battery 660, positioned within the pump housing 628 to provide power to the pump chamber or elements 640 and the controller 644. The battery 660 may be similar in size and electrical output to batteries used in implantable medical devices, such as pacemakers and implantable cardioverter-defibrillators. For example, the battery 660 may comprise a lithium-ion battery, as known in the art. The battery 660 may be rechargeable either wirelessly or via a wired connection to an external power source. To wirelessly recharge the battery 660, in some embodiments, the pump 612 further comprises an inductive coil 662 (shown in FIG. 15D ) electronically coupled to the pump elements 612 to provide power to the pump elements 612 and/or the rechargeable battery 660. The inductive coil 662 may be configured to generate power when exposed to an electromagnetic field generated by a remote device 650 positioned outside or within the patient's body. A suitable induction coil 662 for generating sufficient power to operate the pump element 640 and other electronic components of the pump 612 and/or to recharge the battery 660 may comprise, for example, a conductive wire or filament positioned on a substrate such as a circuit board. As shown diagrammatically in FIG. 15D, the induction coil 662 may be positioned within the housing 628 along with the other electronic components of the pump 612.

In some embodiments, the pump 612 further comprises a wireless transceiver 664 positioned within the housing 628 configured to receive operating instructions for the pump 612 from a remote computing device 650, such as a smartphone, computer tablet, computer, or computer network 652. As in the previous embodiment, the wireless transceiver 664 may comprise a short-range wireless data transceiver, such as BLUETOOTH®, configured to communicate with a remote computing device 650 positioned near the patient, such as a remote control device located in a holster or carrier worn by the patient. In that case, the remote computing device 650 may act as a relay device configured to transmit or broadcast information 644 received from the controller to other computing devices, the computer network 652, or the Internet. The wireless transceiver 664 may alternatively or additionally comprise a long-range wireless transceiver, for example using Wi-Fi. The long-range transceiver can be configured to transmit the information to a stationary medical or communication device, such as a patient monitoring device located in the patient's residence, or to a wireless router configured to communicate the information to a computer network 652 and/or the Internet. In some examples, the controller 644 is configured to record information about the operation of the pump 612 as well as information about the negative pressure therapy provided to the patient, such as information detected by the sensors 654, 656, 658. The information about the operation of the pump 612 may include, for example, the amount of time the pump 612 has been operating, power usage information about the pump 612, or the remaining charge about the rechargeable battery 660. The processor 646 and memory 648 can be configured to periodically cause the wireless transceiver 664 to transmit this recorded information from the controller 644 to the remote computing device 650 to provide feedback to the patient and/or caregiver about the operational status of the pump 612 and the therapy being provided by the pump 612.

16A-16C, in other embodiments, the pump system 600 includes a controller 644 located outside the patient's body, enclosed within its own separate housing 638. For example, the controller 644 can be a dedicated electronic device, a handheld computing device such as a smartphone, or a computing tablet. In some embodiments, the controller 644 is worn by the patient in a holster, waist bag, or pocket so as to be held in place in close proximity to the pump 612, which is implanted in the body. As in the previous embodiment, the external controller 644 includes a processor 646 and memory 648 configured to control the operation of the pump 612. The controller 644 can be electrically connected to the pump 612 by a percutaneously shielded wire 670. As shown in FIGS. 16A-16C, the wire 670 extends from the controller 644 through a percutaneous access site to the pump 612. Beneficially, because the processing electronics and other components of the controller 644 are located within the housing 638 external to the patient, the pump 612 is smaller than in previous embodiments. Using a smaller pump 612 may make the device easier to implant and remove from the patient.

The processor 646 and memory 648 can transmit operating instructions from the controller 644 to the pump 612 via wires 670. The processor 646 and memory 648 can also receive information about the operation of the pump 612 via the wired connection 670. The controller 644 can also be electrically connected to sensors of the system 600, such as a fluid sensor 654 positioned within the ureteral catheter 614 and/or conduit 642, a retention portion probe 656, and an external pressure sensor 658. As in the previous example, the external controller 644 further includes a power source, such as a battery 660, for providing power to the pump 612. Power can be provided to the pump 612 from the battery 660 within the controller 644 via the wired connection 670. In some examples, the pump 612 may include an auxiliary battery 666 configured to store power received via wires 670 for operating the pump 612.

The controller 644 may further comprise a wireless transceiver 664. As in the previous example, the wireless transceiver 664 can be configured to transmit information about the pump 612, the patient, and the negative pressure therapy received from the pump 612 and sensors 654, 656, 658, as described above, to a remote computer device 650, a computer network 652, or the Internet. For example, the wireless transceiver 664 can transmit information from the controller 644 to a laptop computer or computer server, where the information can be reviewed by a user. The wireless transceiver 664 generally comprises a long-range wireless transceiver that periodically or continuously transmits information from the controller 644 to a remote computer device or network. In some examples, the wireless transceiver 664 is a WiFi transceiver that transmits data to a computer network through a wireless gateway or router. In other examples, the wireless transceiver can be a cellular transceiver (e.g., a transceiver configured to transmit data over a 3G or 4G mobile network).
(Catheter Connector Example)

Having described the pump system 600 and the electrical components of the pump 612, aspects of the fluidics and fluid flow through the pump 612 will now be described in further detail with reference to FIGS. 17A and 17B . As previously discussed, the pump 612 includes a fluid port 630 configured to provide a fluid connection between the ureteral catheter 614 and/or the outflow catheter 616 and the pump chamber or pump element 640. The fluid port 630 can be configured to connect to a multi-lumen or coaxial catheter or catheter segment, such as a coaxial catheter in which the ureteral catheter 614 forms a central lumen and the outflow catheter 616 forms an annular outer lumen surrounding the ureteral catheter 614. In a system including two ureteral catheters 614, the fluid port 630 can include two inner or central lumens configured to engage the end 620 of the ureteral catheter 614 and an outer lumen configured to engage the end 632 of the outflow catheter 616. As discussed above, the use of a coaxial or multi-lumen catheter reduces the number of incisions made through the bladder wall during implantation of the pump system 600.

17A and 17B, the fluid port 630, configured to receive a coaxial or multi-lumen catheter, includes a first tubular section or portion 672 configured to receive the ureteral catheter 614 and a second tubular section or portion 674 configured to receive the outflow catheter 616 and enclosing the first tubular section 672. The tubular sections 672, 674 are sized to engage the corresponding ends 620, 632 of the ureteral catheter 614 and the outflow catheter 616, respectively. For example, the inner tubular section 672 can have an inner diameter D3 corresponding to the outer diameter of the ureteral catheter 614. In some embodiments, the diameter D3 can be from about 0.33 mm to about 3.0 mm or from about 1.0 mm to 2.0 mm. The second tubular section 674 can have an inner diameter D4 corresponding to the outer diameter of the outflow catheter 616. Diameter D4 can be, for example, from about 0.5 mm to about 6.0 mm or from about 2.0 mm to 4.0 mm.

Fluid from the urinary catheter 614 passes in the direction of arrow A1 through the fluid port 630 and the first tubular portion 672 of the fluid conduit 642 to the inflow port 676 of the pump chamber or pump element 640. As discussed above, the pump chamber or element 640 can comprise any of a variety of rotational or positive displacement pumping mechanisms that draw fluid (e.g., urine) into the inflow port 676 by creating negative pressure within the lumen 618 of the urinary catheter 614. For example, the pumping mechanism can comprise an impeller, rotor, or piezoelectric diaphragm. An outflow port 678 of the pump chamber or element 640 is located on the opposite side of the pump chamber or element 640 from the inflow port 676. The outflow port 678 is fluidly connected to the second tubular portion 674 of the fluid port 630 such that fluid exiting the pump chamber or element 640 passes in the direction of arrow A2 through the second tubular portion 674 and into the outflow catheter 616. As discussed above, the drained fluid then passes through the outflow catheter 616 and into the bladder.

In other examples, as discussed in more detail herein, a tubular shunt may be positioned within the bladder wall rather than including a coaxial or multi-lumen catheter. In such examples, the ureteral catheter 614 and the outflow catheter 616 may both pass through openings in the bladder wall defined by the tubular shunt. The ureteral catheter 614 and the outflow catheter 616 may extend from the tubular shunt to the pump 612. In such cases, the pump 612 may include separate fluid ports 630, one port configured to engage the end 620 of the ureteral catheter 614 and a second port of approximately the same size configured to engage the end 632 of the outflow catheter 616. Advantageously, using a tubular shunt avoids the need for multiple incisions in the bladder wall while allowing the ureteral catheter 614 and the outflow catheter 616 to remain separate and, in some cases, spaced apart from one another along their entire lengths.
Exemplary Multi-Lumen Catheters and Tubular Shunts

Several examples of multi-lumen catheter portions 680 and shunts 682 for insertion through the bladder wall that can be used in conjunction with the pump system 600 disclosed herein are shown in Figures 18A-18D. Figures 19A and 19B are schematic diagrams illustrating how the tubing portion 680 or shunt 682 can be secured through an opening in the bladder wall, for example, by a purse-string suture 690. Figures 18A and 18D show an example of a multi-lumen catheter portion 680 in which a section of the ureteral catheter 614 is positioned within the annular lumen of the outflow catheter 616. Figures 18B and 18C show an example of a tubular sheath or shunt 682 that encloses both the ureteral catheter 614 and the outflow catheter 616. The catheter portion 680 and shunt 682 of Figures 18A-18D also include structure to reduce, absorb, or resist stresses that may be applied to the catheters 614, 616 due to patient movement and/or bladder contractions during use. In particular, the multi-lumen catheter portion 680 and shunt 682 are configured to be flexible and/or stretchable in the radial and axial directions. The multi-lumen catheter portion 680 and shunt 682 may also be made of an elastic material.

As used herein, a radially flexible structure is capable of absorbing a radially inwardly directed force without breaking. While the structure may deform slightly due to the applied force, the structure generally remains capable of performing its intended function both as the radially inwardly directed force is applied and once the force is removed. An elastic material or structure is capable of absorbing a radially inwardly directed force and recovering its previous shape once the radially inwardly directed force is removed. Similarly, an axially flexible and/or stretchable structure is capable of increasing in length when an axial force is applied without breaking. The elastic material or structure returns to its previous axial length once the axial force is removed. The radially and axially flexible and/or stretchable multi-lumen catheter portion 680 and shunt 682 allow for patient mobility without dragging body tissue, organs, percutaneous access sites, or other structures within and outside the urinary tract, avoiding injury to body tissue and causing pain, and ensuring that the bodily implanted catheters 614, 616 and pump 612 are not pulled out of position as an ambulatory patient changes position or moves while performing normal activities.

The multi-lumen catheter portion 680 and shunt 682 are generally formed from materials similar to the other portions of the catheters 614, 616. In some embodiments, the multi-lumen catheter portion 680 and shunt 682 can be configured to be more flexible, deformable, or elastic than the other portions of the catheters 614, 616 because the portion 680 and shunt 682 must absorb the contractile forces of the bladder wall. The multi-lumen portion 680 and shunt 682 can be formed from a suitable coated or uncoated biocompatible polymer material, such as materials used for conventional urinary catheters. Exemplary materials can be comprised of one or more biocompatible polymers, such as polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone-coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate). The overall outer diameter D5 of the multi-lumen portion 680 and shunt 682 is desirably as small as possible to minimize the size of the incision in the bladder wall while allowing sufficient fluid flow through the catheters 614, 616. For example, the outer diameter D5 can be from about 0.5 mm to about 6.0 mm, or from about 2.0 mm to about 4.0 mm.

As shown in FIG. 18A, the multi-lumen catheter portion 680 includes a ureteral catheter 614 enclosed by an outflow catheter 616. The ureteral catheter 614 includes an accordion-shaped section 684 configured to increase in length when retracted. In some embodiments, the outflow catheter 616 can be connected to the ureteral catheter 614 and configured to exert a biasing force thereon. The biasing force can cause the ureteral catheter 614 to return to its normal length when an axial force (e.g., a stretching force) is no longer applied to the catheters 614, 616. In this manner, the length L5 of the catheter 614 can increase as the patient moves, for example, from a normal length of about 1 cm to about 10 cm to an extended length of about 2 cm to about 15 cm. Once the patient stops moving, the biasing force applied by the outer catheter 616 causes the accordion section 684 of the ureteral catheter 614 to return to its normal length.

To deploy the multi-lumen catheter portion 680 of FIG. 18A, the catheter portion 680 can be positioned through an incision in the bladder wall. The catheters 614, 616 can then be expanded using inflatable elements such as balloons. Bladder tension is expected to cause the bladder wall to seal around the expanded catheters 614, 616 as the bladder empties, thereby securing the multi-lumen catheter portion 680 in place within the bladder wall without the need for sutures. However, as shown in FIGS. 19A and 19B, a loose purse-string suture 690 can be used to further secure the multi-lumen catheter portion 680 to the bladder wall.

As shown in FIG. 18B, an example of a sheath or shunt 682 configured to be positioned through an incision in the bladder wall is illustrated. Both the outflow catheter 616 and the ureteral catheter 614 extend through a lumen 686 of the sheath or shunt 682. The sheath or shunt 682 in FIG. 18B can be formed from an elastomeric material configured to absorb forces applied to the catheters 614, 616, or the sheath or shunt 682. As used herein, "elastomeric material" refers to a material or structure that absorbs a deforming force and returns to its previous or normal size and shape after the force is removed. To avoid leakage and completely seal the bladder, the sheath or shunt 682 can be tightly fitted around the catheters 614, 616 to resist catheter movement, which may occur when a portion of the catheters 614, 616 is pulled or moved.

To deploy the sheath or shunt 682 within the bladder wall, the sheath or shunt 682 can be sutured in place using conventional techniques. For example, as shown in FIGS. 19A and 19B, the sheath or shunt 682 can be secured to the bladder wall using a purse string suture 690. Desirably, the suture 690 is not tightened completely to avoid constricting the bladder wall around the sheath or shunt 682. In some embodiments, as shown in FIG. 19B, the sheath or shunt 682 can protrude into the bladder a suitable distance to ensure it does not slip out of the bladder due to patient movement or bladder contraction.

Another example of a sheath or shunt 682 configured to pass through the bladder wall is illustrated in FIG. 18C. As shown in FIG. 18C, the sheath or shunt 682 comprises a telescoping arrangement including a first or inner section or compartment 692 having a length L6, e.g., about 5 mm to about 5 cm. The inner section or compartment 692 is slidably received within and sealed to a second or outer section or compartment 694 having a length L7, e.g., about 5 mm to about 5 cm. The telescoping sheath or shunt 682 is configured to extend axially when the catheters 614, 616 are pulled or moved away from each other. Thus, the telescoping arrangement acts to absorb stresses applied to the catheters 614, 616 or the sheath 662. In some embodiments, the inner section or compartment 692 and the outer section or compartment 694 can be biased inward such that the sheath or shunt 682 returns to its contracted length once the biasing force is removed.

Figure 18D shows another embodiment of a multi-lumen catheter portion 680. As with the multi-lumen catheter portion 680 of Figure 18A, the catheters 614, 616 shown in Figure 18D form an annular lumen for the outflow catheter 616 and a multi-lumen portion 680 in which the ureteral catheter 614 is received. The multi-lumen portion 680 of the catheters 614, 616 is formed from an elastomeric material (i.e., a material that can stretch axially when a force is applied to the material and return to its previous state once the force is removed) to absorb any stress applied to the catheters 614, 616. For example, the catheter portion 680 may be configured to extend from a normal length L8 of about 1 cm to about 10 cm to an extended length of about 2 cm to about 15 cm. The elastomeric or expandable portions of the catheters 614, 616 can be formed from biocompatible elastomeric materials such as synthetic or natural rubber, silicone, and other elastomeric polymers.
Method of Implanting a Pump Assembly for an Ambulatory Patient

20, a method for inserting and/or implanting components of pump system 600 into a patient's body includes introducing one or two ureteral catheters 614 into the patient's urinary tract, as shown in step 710. The ureteral catheters 614, 616 can be inserted into the urinary tract through the urethra using conventional techniques for deploying ureteral stents, for example, as described in the above-referenced U.S. Patent Application Publication No. 2020/0094017 to Erbey et al., entitled "Coated Ureteral Catheter or Ureteral Stent and Method."

In some embodiments, a cystoscope is used to assist in advancing the catheter through the urethra, bladder, and urethral opening into the ureter. For example, to deploy a ureteral catheter 614, a medical professional may insert a cystoscope into the urethra to provide a channel for tools to enter the bladder. The ureteral opening is then visualized, and a guidewire is inserted through the cystoscope and ureter until the tip of the guidewire reaches the renal pelvis. Once the guidewire reaches the renal pelvis, the cystoscope can be removed, and a pusher tube is advanced over the guidewire to the renal pelvis. The guidewire is then removed while the pusher tube remains in place, acting as a deployment sheath. The ureteral catheter 614 is inserted through the pusher tube/sheath and advanced toward the renal pelvis.

In step 712, once the catheter tip or end 622 of the ureteral catheter 614 reaches the renal pelvis, the ureteral catheter 614 is deployed within the renal pelvis or kidney by expanding the retention portion 624 to its deployed configuration or state. In some embodiments, the retention portion 624 is automatically biased to its deployed position. In that case, the ureteral catheter 614 may be automatically deployed once it protrudes from the distal end of the pusher tube. In other embodiments, the retention portion 624 of the ureteral catheter 614 can be deployed by removing the guidewire from the lumen 618 of the ureteral catheter 614 or by some other triggering mechanism, thereby allowing the catheter 614 to adopt its deployed configuration.

The method for implanting the pump assembly or pump system 600 further includes the step of implanting the pump 612 in the abdominal cavity, peritoneum, or subcutaneous cavity. To implant the pump 612, in step 714, an incision is made to gain access to the desired implantation site or location. For example, a medical professional may make an incision of approximately 1 cm to 10 cm, or approximately 5 cm, in the patient's abdomen at a location near the kidney or renal pelvis. Once the incision is made, in step 716, the pump 612 is inserted through the incision and placed at the desired implantation site or location within the abdominal cavity, peritoneum, or subcutaneous space. For example, the pump 612 can be placed against the peritoneum. The medical professional may use surgical sutures to secure the pump 612 in place against the peritoneal tissue.

In step 718, the method further includes making one or more incisions in the bladder wall for the ureteral catheter 614 and the outflow catheter 616. As discussed above, the ureteral catheter 614 and the outflow catheter 616 can be joined together and passed through the bladder wall through a single incision using the multi-lumen catheter portion 680 and shunt 682 shown in Figures 18A-18D. When the catheters 614, 616 are joined together, only a single incision in the bladder wall is required.

Once the incision in the bladder wall is made, in step 720, the multi-lumen catheter portion 680 or shunt 682 is inserted through the incision and secured in place. As discussed above, tension in the bladder causes the bladder wall to press against the outer surface of the multi-lumen catheter portion 680 or shunt 682, which may effectively seal the bladder. To further secure the catheter portion 680 or shunt 682 in place, the medical professional may tie a loose purse-string suture 690 around the opening in the bladder wall to hold the bladder wall against the catheter portion 680 or shunt 682, as shown in FIGS. 19A and 19B. As discussed above, in some embodiments, the purse-string suture 690 may not be fully tightened, but may be tied tightly enough to draw the bladder in tension to the outer surface of the shunt 682. As shown in FIG. 19B, the shunt 682 can be extended at least a short distance into the bladder to ensure that it does not slip out of the opening in the bladder wall.

Once the catheter portion 680 or shunt 682 is secured to the bladder wall, in step 722, the catheters 614, 616 can be inserted through the opening in the bladder wall, and the ends 620, 632 of the catheters 614, 616 can be secured to the pump 612. For example, the end 620 of the ureteral catheter 614 can be secured to a corresponding portion of the fluid port 630 of the pump 612. Similarly, the end 632 of the outflow catheter 616 can be secured to a corresponding portion of the same fluid port 630, or, for pumps 612 with two fluid ports, to a different fluid port. The connection between the catheters 614, 616 and the fluid port 630 is sealed to prevent leakage.

In step 724, optionally, a wire, such as a shielded percutaneous wire 670, can be extended from the pump 612 through the percutaneous access site to the external controller 644 and/or power supply. Once the wire 670 is connected, the pump 612 can be configured to receive power from the external device and begin operating to provide negative pressure therapy for the patient. Alternatively, for a wireless connection, a remote power device can be brought into proximity with the pump 612 to charge the battery 660 in the pump 612 or controller 644. Once the battery 660 is wirelessly charged, the pump 612 can be operated to provide negative pressure therapy to the patient.
(Pump assembly using a percutaneous ureteral catheter)

21A and 21B, a pump assembly or system 800 is illustrated that includes a bypass catheter 814 configured to provide negative pressure therapy to a patient's kidney or renal pelvis. However, unlike the previous example, the bypass catheter 814, which may be referred to as a percutaneous nephrostomy tube or urinary bypass catheter, is deployed into the kidney or renal pelvis through a percutaneous access site rather than through the urinary tract. An exemplary catheter that may be used to access the kidney and/or renal pelvis through a percutaneous access site is disclosed in U.S. Patent Application Publication No. 2019/0105465 to Erbey et al., entitled "Percutaneous Ureteral Catheter," the disclosure of which is incorporated by reference in its entirety.

As shown in FIG. 21A, the bypass catheter 814 includes an elongate tube defining a drainage lumen 818 extending from a proximal end 820 (shown in FIG. 21B) to a distal end 822. The elongate tube includes a retention portion 824 configured to be deployed within the patient's renal pelvis 802, kidney 804, and/or bladder. The catheter 814 may be inserted through a percutaneous access site, which may be formed in a conventional manner, such as by inserting the tip of a needle through the skin and into the abdomen.

The extension tube of the bypass catheter 814 can be formed from and/or consist of one or more biocompatible polymers, such as polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone-coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate). As in the previous embodiment, a portion of the catheter 814 can also consist of and/or be impregnated with a metallic material, such as copper, silver, gold, nickel-titanium alloy, stainless steel, and/or titanium. The catheter 814 should be long enough to extend from the renal pelvis 802 through the kidney 804 to the pump 812, which is implanted in the body, as shown in FIG. 21B. The size of the catheter 814 can range from about 1 Fr to about 9 Fr (French catheter scale), or from about 2 Fr to about 8 Fr, or can be about 4 Fr. In some examples, the catheter 814 can have an outer diameter ranging from about 0.33 mm to about 3.0 mm, or from about 0.66 mm to 2.33 mm, or from about 1.0 mm to 2.0 mm, and an inner diameter ranging from about 0.165 mm to about 2.40 mm, or from about 0.33 mm to 2.0 mm, or from about 0.66 mm to about 1.66 mm.

The retention portion 824 of the catheter 814 can be integrally formed with the distal end 822 of the catheter 814, or can be a separate structure mounted to the distal end 822 of the catheter 814 by conventional fasteners or adhesives. A number of exemplary retention portions 824 suitable for retaining the distal end 822 of the catheter 814 within the renal pelvis 802 are provided in the previous exemplary embodiment of the ureteral catheter 614. For example, retention portions 824 comprising one or more of a coil, a funnel, a cage, a balloon, and/or a sponge can be adapted for use with a bypass catheter 814. In some cases, such retention portions 824 can be adapted for use with a urinary bypass catheter 814, for example, by inverting the retention portion 814 to account for the fact that the urinary bypass catheter 814 enters the renal pelvis 802 through the kidney 804, rather than through the ureter.

Regardless of the embodiment selected, the retention portion 824 creates a circumferential or protected surface area to prevent urinary tract tissue from restricting or obstructing the fluid column extending between the renal unit of the kidney 804 and the drainage lumen 818 of the catheter 814. In some examples, such a retention portion 824 may include an inwardly facing or protected side or surface area with one or more drainage openings, perforations, and/or ports 826 for receiving fluids, such as urine, produced by the kidney 804, and an outwardly facing side or protected surface area that may be free or substantially free of drainage ports 826. As in the previous embodiment, desirably, the inwardly facing side or protected surface area and the outwardly facing side or protected surface area are configured such that when negative pressure is applied through the tube of the catheter 814, urine is drawn into the lumen 818 of the tube through the one or more outlet ports 826 while mucosal tissue, such as tissue of the ureter and/or renal pelvis 802, is prevented from significantly obstructing the one or more outlet ports 826. As with the ureteral catheters previously described, the size and spacing between the outlet ports 826 can be varied to achieve different distributions of negative pressure within the renal pelvis 802 and/or kidney 804, as disclosed herein. In some embodiments, the one or more outlet ports 826 each have a diameter of about 0.0005 mm to about 2.0 mm, or about 0.05 mm to 1.5 mm, or about 0.5 mm to about 1.0 mm. In some examples, the exhaust ports 826 can be non-circular and can have a surface area ^of about 0.0002 ^mm to about 100 mm, or about 0.002 ^{mm to} about 10 mm, or about 0.2 ^mm to about 1.0 ^mm . The exhaust ports 826 can be spaced equidistantly along the axial length of the retention portion 824. In other examples, the exhaust ports 826 closer to the base or proximal end of the retention portion 824 may be spaced closer together to increase fluid flow through the more distal exhaust ports 826 compared to examples in which the ports 826 are evenly spaced.

Referring to FIG. 21B , an elongated tube defining the drainage lumen 818 of the bypass catheter 814 extends from the posterior aspect of the kidney 804 to a bodily implanted pump 812. As in the previous embodiment, the bodily implanted pump 812 can be positioned within the abdominal, peritoneal, or subcutaneous cavity. A proximal or second end 820 of the bypass catheter 814 connects to a fluid port 830 of the pump 812, as in the previous embodiment. The system may further include an outflow catheter 816 extending from the same fluid port 830 or from a different fluid port of the pump 812. The outflow catheter 816 is configured to provide fluid (e.g., urine) that drains from the pump 812 into the bladder through an opening in the bladder wall. Once delivered to the bladder, the fluid (e.g., urine) can be drained from the body naturally or through a bladder catheter inserted through the urethra.

The pump 812 is similar to or the same as the pump 612 described in the previous embodiment. As in the previous embodiment, the pump 812 includes a pump chamber or pump element 840 that is fluidly connected to a fluid port 830 via a conduit 842. The pump 812 further includes a controller 844. As shown in FIG. 21B, the controller 844 is integral with the pump 812 and enclosed within the housing 828 of the pump 812. In other embodiments, the controller 844 may be an external controller, as described in connection with FIGS. 16A-16C.

As in the previous embodiment, the controller 844 includes a processor 846 and memory 848 configured to control the operation of the pump 812. The controller 844 may further include a power source, such as a rechargeable battery 860 and/or an induction coil 862, for providing power to the pump 812.

The system 800 further includes sensors 854, 856, 858 electrically connected to the processor 846 and memory 848 of the controller 844. Specifically, as in the previous embodiment, the system 800 can include a fluid sensor 854 positioned, for example, within the ureteral catheter 814 and/or conduit 842, the retention portion probe 856, and an external pressure sensor 858. As in the previous embodiment, the controller 844 is configured to receive and process information from the sensors 854, 856, 858 to control the operation of the pump 812, particularly to regulate the power output of the pump and to control the amount of negative pressure provided to the kidney and/or renal pelvis through the drainage lumen 818 of the ureteral catheter 814.

The controller 844 may further include a wireless transceiver 864. The wireless transceiver 864 may be configured to transmit information about the pump 812, the patient, and the negative pressure therapy received from the pump 812 and sensors 854, 856, 858, as described above, to a remote computer device 850, a computer network 852, or the Internet. The wireless transceiver 864 may include a short-range or long-range transceiver, such as BLUETOOTH®. The wireless transceiver 864 may be configured to periodically or continuously transmit information from the controller 844 to the remote computer device 850 and/or the computer network 852.
(Exemplary ureteral retention part)

Further examples of retention portions for ureteral catheters are provided herein that can be used in conjunction with any of the ureteral catheter retention portions 154, 624 described above and shown, for example, in Figures 6, 15A-15D, and 16A-16C. Any of these retention portions disclosed herein can be formed from the same material as the rest of the ureteral catheter and can be integral with or connected to the rest of the ureteral catheter. In other examples, the retention portion can be formed from a different material, such as those discussed above with respect to the drainage lumen, and can be connected to the rest of the ureteral catheter. For example, the retention portion can be formed from any of the aforementioned materials, such as polymers such as polyurethane, flexible polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone, silicon, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate).

With reference to Figures 22A-22F, the retention portion 130b of the ureteral catheter may be configured to be flexible and bendable to permit positioning of the retention portion 130b within the patient's ureter and/or renal pelvis. The retention portion 130b is desirably sufficiently bendable to absorb forces exerted on the ureteral catheter 112b and to prevent such forces from being transmitted to the ureter. For example, when the retention portion 130b is pulled in the proximal direction P (shown in Figure 22A) toward the patient's bladder, the retention portion 130b may be sufficiently flexible to begin to uncoil or straighten so that it can be withdrawn through the ureter. Similarly, when reinserted into the renal pelvis or other suitable region within the ureter, the retention portion 130b can be biased to return to its expanded configuration.

In some embodiments, the retention portion 130b is integral with the tubing 122b of the ureteral catheter 112b. In that case, the retention portion 130b can be formed by imparting a bend or inflection to the tubing 122b that is sized and shaped to retain the catheter at the desired fluid collection location. Suitable bends or coils can include pigtail coils, cork screw coils, and/or helical coils, as shown in FIGS. 22A-23F. For example, the retention portion 130b can comprise one or more radially and longitudinally extending helical coils configured to contact and passively retain the catheter 112b within the ureter adjacent to or within the renal pelvis, as shown in FIGS. 22A-23F. In other embodiments, the retention portion 130b is formed from a radially flared or tapered portion of the tubing 122b. For example, the retention portion 130b can further comprise a fluid collection portion as shown in FIGS. 28A-50B, such as a tapered or funnel-shaped inner surface 186b. In other embodiments, the retention portion 130b can comprise a separate element connected to and extending from the catheter body or tube 122b.

In some embodiments, the retention portion 130b can further include one or more perforation sections, such as drain holes, perforations, or ports 132b, 1232 (e.g., as shown in Figures 22A-22E, 23A, 23E, 24-27, 34, 41A, 41B, 42, 43, and 48A-50B). The drain port 132b can be located at the open distal end 120b, 121b of the tube 122b, as shown, for example, in Figure 23D. In other embodiments, the perforated section and/or drainage ports 132b, 1232 are located along the sidewall 109b of the distal portion 118b of the catheter tube 122b, as shown in Figures 22A-22E, 23A, 23E, 24-27, 34, 41A, 41B, 42, 43, and 48A-50B, or within the material of the retention portion, such as the sponge material of Figures 48A, 48B, 49A, and 49B. The drainage ports or holes 132b, 1232 can be used to assist in fluid collection, allowing fluid to enter the drainage lumen for removal from the patient's body. In other embodiments, the retention portion 130b is dedicated to retention structure and fluid collection, and/or application of negative pressure is provided by structure elsewhere on the catheter tube 122b.

In some embodiments, such as those shown in Figures 22B-E, 23D-G, 28B, 28C-28E, 29, 31A-44B, 46B, 47A, 48B, and 49A-50B, at least a portion, most, or all of the drainage hole, port, or perforation 132b, 1232 is positioned within the ureteral catheter 112b within a protected surface area or inner surface area 1000 such that tissue 1003 from the kidney (shown in Figure 22F) does not directly contact or partially or completely occlude the protected drainage hole, port, or perforation 133b. For example, as shown in FIGS. 23F, 28D, 33B, 38C, 48B, 49B, and 50B, when negative pressure is induced within the ureter and/or renal pelvis, a portion of the ureteral and/or renal mucosal tissue 1003 (shown in FIG. 22F) may be drawn against the periphery 1002 or protective surface area 1001 or outer region of the retention portion 130b, partially or completely occluding some drainage holes, ports, or 134b located on the periphery 1002 or protective surface area 1001 of the retention portion 130b.

At least a portion of the protected drain port 133b located on the protected or inner surface area 1000 of the retaining portion 130b will not be partially or completely occluded when such tissue 1003 contacts the periphery 1002 or protective surface area 1001 or outer region of the retaining portion 130b. Furthermore, the risk of injury to tissue 1003, 1004 from pinching or contact with the drain port 133b can be reduced or ameliorated. The configuration of the periphery 1002 or protective surface area 1001 or outer region of the retaining portion 130b depends on the overall configuration of the retaining portion 130b. Generally, the periphery 1002 or protective surface area 1001 or outer region of the retaining portion 130b contacts and supports the kidney tissue 1003 (shown in FIG. 22F), thereby preventing blockage or obstruction of the protected drain hole, port, or perforation 133b.

For example, as shown in FIG. 23E , an exemplary retention portion 1230 is shown comprising a plurality of helical coils 1280, 1282, 1284. The outer periphery 1002 or protective surface area 1001 or outer region of the helical coils 1280, 1282, 1284 contacts and supports kidney tissue 1003, preventing occlusion or obstruction of a protected drainage hole, port, or perforation 1233 located within the protected or inner surface area 1000 of the helical coils 1280, 1282, 1284. The outer periphery 1002 or protective surface area 1001 or outer region of the helical coils 1280, 1282, 1284 provides protection for the protected drainage hole, port, or perforation 1233. In FIG. 23F, kidney tissue 1003 is shown surrounding and contacting at least a portion of the periphery 1002 or protected surface area 1001 or outer region of the helical coils 1280, 1282, 1284, which prevents contact of the kidney tissue 1003 with the protected or inner surface area 1000 of the helical coils 1280, 1282, 1284, thereby preventing partial or complete obstruction of the protected drainage hole, port, or perforation 1233 by the kidney tissue 1003.

Similarly, other embodiments of ureteral retention portion configurations shown in FIGS. 28A-50B also provide a perimeter 1002 or protective surface area 1001 or outer region that contacts and supports kidney tissue 1003 (shown in FIG. 22F) and can prevent blockage or obstruction of protected drainage holes, ports, or perforations 133b, 1233 located within the protected or inner surface area 1000 of the retention portion. Each of these embodiments will be discussed further below.

22A-22E, an exemplary retention portion 130b for a ureteral catheter is illustrated, comprising multiple helical coils, such as one or more full coils 184b and one or more half or partial coils 183b. The retention portion 130b, along with the multiple helical coils, is movable between a retracted position and a deployed position. For example, a generally straight guidewire can be inserted through the retention portion 130b to maintain the retention portion 130b in a generally straight, retracted position. When the guidewire is removed, the retention portion 130b can transition to its coiled configuration. In some examples, the coils 183b, 184b extend radially and longitudinally from the distal portion 118b of the tube 122b. In the exemplary embodiment, the retention portion 130b comprises two full coils 184b and one half coil 183b. For example, the outer diameter of the full coil 184b, indicated by line D11, may be approximately 18±2 mm, the diameter D12 of the half coil 183b may be approximately 14±2 mm, and the coiled retention portion 130b may have a height H10 of approximately 16±2 mm.

The retention portion 130b can further include one or more drain holes 132b, 1232 (e.g., as shown in FIGS. 22A-22E, 23A, and 23E) configured to draw fluid into the interior of the catheter tube 122b. In some embodiments, the retention portion 130b can include two, three, four, five, six, seven, eight, or more drain holes 132b, 1232, as well as additional holes 110b at the distal tip or end 120b of the retention portion. In some embodiments, the diameter of each of the drain holes 132b, 1232 (e.g., as shown in FIGS. 22A-22E, 23A, and 23E) can range from about 0.7 mm to 0.9 mm, and is preferably about 0.83±0.01 mm. In some embodiments, the diameter of the additional holes 110b (e.g., as shown in FIGS. 22A-22E, 23A, and 23E) at the distal tip or end of the retention portion 130b can range from about 0.165 mm to about 2.39 mm, or from about 0.7 mm to about 0.97 mm. The distance between adjacent exhaust holes 132b, specifically the linear distance between the nearest outer edges of adjacent exhaust holes 132b, 1232 when the coil is straightened, can be about 15 mm ± 2.5 mm, or about 22.5 ± 2.5 mm or greater.

As shown in Figures 22A-22E, in another exemplary embodiment, the distal portion 118b of the exhaust lumen 124b proximal to the retention portion 130b defines a straight or curved central axis L. In some examples, at least half or the first coil 183b and the full or second coil 184b of the retention portion 130b extend about the axis A of the retention portion 130b. The first coil 183b begins or originates from a point where the tube 122b is bent at an angle α ranging from about 15 degrees to about 75 degrees from the central axis L, preferably about 45 degrees, as indicated by the angle α. As shown in Figures 22A and 22B, prior to insertion into the body, the axis A can be coextensive with the longitudinal central axis L. In other embodiments, as shown in Figures 22C-22E, prior to insertion into the body, axis A extends from central longitudinal axis L and is curved or angled therewith, for example, at angle β.

In some embodiments, the multiple coils 184b can have the same or different inner and/or outer diameters D10 and heights H12 between adjacent coils 184b. In that case, the outer diameter D11 of each of the coils 184b may range from about 10 mm to about 30 mm. The height H12 between each of the adjacent coils 184b may range from about 3 mm to about 10 mm.

In other embodiments, the retention portion 130b is configured to be inserted within a tapered portion of the renal pelvis. For example, the outer diameter D11 of the coil 184b can increase toward the distal end 120b of the tube 122b, resulting in a helical structure having a tapered or partially tapered configuration. For example, the distal or maximum outer diameter D10 of the tapered helical portion can range from about 10 mm to about 30 mm, corresponding to the dimensions of the renal pelvis, and the outer diameter D11 of each adjacent coil can decrease closer to the proximal end 128b of the retention portion 130b. The overall height H10 of the retention portion 130b can range from about 10 mm to about 30 mm.

In some embodiments, the outer diameter D11 of each coil 184b and/or the height H12 between each of the coils 184b can vary in a regular or irregular manner. For example, the outer diameter D11 of the coil or the height H12 between adjacent coils can increase or decrease by a regular amount (e.g., about 10% to about 25% between adjacent coils 184b). For example, for a retention portion 130b having three coils (e.g., as shown in FIGS. 22A and 22B), the outer diameter D12 of the proximal-most or first coil 183b can be about 6 mm to about 18 mm, the outer diameter D23 of the middle or second coil 185 can be about 8 mm to about 24 mm, and the outer diameter D23 of the distal-most or third coil 187 can be about 10 mm to about 30 mm.

The retention portion 130b may further include drainage perforations, holes, or ports 132b disposed on or adjacent to the retention portion 130b and on or through the sidewall 109b of the catheter tube 122b to allow urinary waste to flow from outside the catheter tube 122b to the inner drainage lumen 124b of the catheter tube 122b. The location and size of the drainage ports 132b may vary depending on the desired flow rate and configuration of the retention portion 130b. The diameter D21 of each of the drainage ports 132b may independently range from about 0.005 mm to about 1.0 mm. The spacing D22 between the nearest edges of each of the drainage ports 132b may independently range from about 1.5 mm to about 5 mm. The drainage ports 132b may be spaced in any arrangement, for example, a random, linear, or offset arrangement. In some embodiments, the exhaust port 132b may be non-circular and may have a surface area of approximately 0.00002 to 0.79 mm ² .

In some embodiments, as shown in FIG. 22A, the exhaust ports 132b are located around the entire outer periphery 1002 or protected surface area 1001 of the sidewall 109b of the catheter tube 122b, increasing the amount of fluid that can be drawn into the exhaust lumen 124b (as shown in FIGS. 22A and 22B). In other embodiments, as shown in FIGS. 22B-22E and 23A-23E, the exhaust holes, ports, or perforations 132b are located essentially only on or on the protected or inner surface area 1000 or radially inward-facing side 1286 of the coil 184b, preventing blockage or obstruction of the exhaust ports 132b, 1232, and the outward-facing side 1288 of the coil may be essentially free of or devoid of exhaust ports 132b, 1232. The periphery 189b, 1002 or protected surface area 1001 or outer region 192b of the helical coils 183b, 184b, 1280, 1282, 1284 can contact and support kidney tissue 1003 (shown in FIG. 22F ) and prevent blockage or obstruction of protected drainage holes, ports, or perforations 133b, 1233 located within the protected or inner surface area 1000 of the helical coils 183b, 184b, 1280, 1282, 1284. For example, when negative pressure is induced within the ureter and/or renal pelvis, the ureteral and/or renal mucosal tissue can be drawn against the retention portion 130b and occlude several drainage ports 134b on the periphery 189b, 1002 of the retention portion 130b. Evacuation ports 133b, 1233 located on the radially inward side 1286 or protected or inner surface area 1000 of the retention structure will not be significantly obstructed when such tissue 1003, 1004 contacts the outer periphery 189b, 1002 or protected surface area 1001 or outer region of the retention portion 130b. Furthermore, the risk of injury to tissue from pinching or contact with the evacuation ports 132b, 133b, 1233 or protected evacuation holes, ports, or perforations 133b, 1233 can be reduced or ameliorated.

With reference to Figures 22C and 22D, another embodiment of a ureteral catheter 112b is illustrated having a retention portion 130b comprising multiple coils 184b. As shown in Figure 22C, the retention portion 130b comprises three coils 184b extending about axis A. Axis A is a curved arc extending from a central longitudinal axis L of a portion of the drainage lumen 181b proximal to the retention portion 130b. The curvature imparted to the retention portion 130b can be selected to correspond to the curvature of the renal pelvis, which comprises a conical, receptacle-shaped cavity.

As shown in FIG. 22D, in another exemplary embodiment, the retention portion 130b can include two coils 184b extending about an angled axis A. The angled axis A extends at an angle from the central longitudinal axis L and is angled relative to an axis that is generally perpendicular to the central axis L of the drainage lumen portion, as indicated by angle β. The angle β can range from about 15 to about 75 degrees (e.g., from about 105 to about 165 degrees relative to the central longitudinal axis L of the drainage lumen portion of the catheter 112b).

Figure 22E shows another embodiment of a ureteral catheter 112b. The retention portion comprises three helical coils 184b extending about axis A. Axis A is angled relative to the horizontal, as indicated by angle β. As in the previously described embodiments, angle β can range from about 15 to about 75 degrees (e.g., from about 105 to about 165 degrees relative to the central longitudinal axis L of the drainage lumen portion of the catheter 112b).

In some embodiments shown in FIGS. 23A-23E, the retention portion 1230 is integral with the tube 1222. In other embodiments, the retention portion 1230 can comprise a separate tubular member connected to and extending from the tube or exhaust lumen 1224.

In some embodiments, the retention portion comprises a plurality of radially extending coils 184b. The coils 184b are configured in a funnel shape, thereby forming a funnel-shaped support. Some examples of coil funnel-shaped supports are shown in Figures 22A-23E.

In some embodiments, at least one sidewall 119b of the funnel-shaped support comprises at least a first coil 183b having a first diameter and a second coil 184b having a second diameter, the first diameter being less than the second diameter. The maximum distance between a portion of the sidewall of the first coil and a portion of an adjacent sidewall of the second coil can range from about 0 mm to about 10 mm. In some embodiments, the first diameter of the first coil 183b ranges from about 1 mm to about 10 mm, and the second diameter of the second coil 184b ranges from about 5 mm to about 25 mm. In some embodiments, the diameters of the coils increase toward the distal end of the exhaust lumen, resulting in a helical structure having a tapered or partially tapered configuration. In some embodiments, the second coil 184b is closer to the end of the distal portion 118b of the exhaust lumen 124b than the first coil 183b. In some embodiments, the second coil 184b is closer to the end of the proximal portion 128b of the exhaust lumen 124b than the first coil 183b.

In some embodiments, at least one sidewall 119b of the funnel-shaped support comprises an inwardly facing side 1286 and an outwardly facing side 1288, as discussed below, where the inwardly facing side 1286 comprises at least one opening 133b, 1233 to allow fluid flow into the drain lumen, and the outwardly facing side 1288 is essentially free or absent of openings. In some embodiments, the at least one opening 133b, 1233 has an area ranging ^from about 0.002 mm to about 100 ^mm .

In some embodiments, the first coil 1280 comprises a sidewall 119b having a radially inward-facing side 1286 and a radially outward-facing side 1288, the radially inward-facing side 1286 of the first coil 1280 comprising at least one opening 1233 for permitting fluid flow into the exhaust lumen.

In some embodiments, the first coil 1280 comprises a sidewall 119b having a radially inward-facing side 1286 and a radially outward-facing side 1288, the radially inward-facing side 1286 of the first coil 1280 comprising at least two openings 1233 for permitting fluid flow into the exhaust lumen 1224.

In some embodiments, the first coil 1280 comprises a sidewall 119b having a radially inward-facing side 1286 and a radially outward-facing side 1288, wherein the radially outward-facing side 1288 of the first coil 1280 is essentially free of or does not have one or more openings 1232.

In some embodiments, the first coil 1280 comprises a sidewall 119b having a radially inward-facing side 1286 and a radially outward-facing side 1288, wherein the radially inward-facing side 1286 of the first coil 1280 comprises at least one opening 1233 for permitting fluid flow into the exhaust lumen 1224, and the radially outward-facing side 1288 is essentially free of or does not have one or more openings 1232.

23A-23E, in some embodiments, the distal portion 1218 comprises an open distal end 1220 for drawing fluid into the drainage lumen 1224. The distal portion 1218 of the ureteral catheter 1212 further comprises a retention portion 1230 for maintaining the distal portion 1218 of the drainage lumen or tube 1222 within the ureter and/or kidney. In some embodiments, the retention portion 1230 comprises a plurality of radially extending coils 1280, 1282, 1284. The retention portion 1230 can be flexible and bendable to allow positioning of the retention portion 1230 within the ureter, renal pelvis, and/or kidney. For example, the retention portion 1230 desirably is sufficiently bendable to absorb forces exerted on the catheter 1212 and prevent such forces from being transmitted to the ureter. Additionally, when the retention portion 1230 is pulled in the proximal direction P (shown in FIGS. 22A-22E ) toward the patient's bladder, the retention portion 1230 can be sufficiently flexible to begin to uncoil or straighten so that it can be withdrawn through the ureter. In some embodiments, the retention portion 1230 is integral with the tube 1222. In other embodiments, the retention portion 1230 can comprise a separate tubular member connected to and extending from the tube or drain lumen 1224. In some embodiments, the catheter 1212 comprises a radiopaque band 1234 (shown in FIG. 38A ) positioned on the tube 1222 at the proximal end of the retention portion 1230. The radiopaque band 1234 is visible by fluoroscopic imaging during deployment of the catheter 1212. In particular, the user can monitor the advancement of the band 1234 through the urinary tract via fluoroscopy to determine when the retention portion 1230 is within the renal pelvis and ready for deployment.

In some examples, retention portion 1230 includes perforations, exhaust ports, or openings 1232 in the sidewall of tube 1222. As described herein, the location and size of openings 1232 can vary depending on the desired volumetric flow rate per opening and the size constraints of retention portion 1230. In some examples, diameter D21 of each of openings 1232 can independently range from about 0.05 mm to about 2.5 mm and have an area of about 0.002 mm ² to about 5 mm ^2. Openings 1232 can be positioned to extend along sidewall 119b of tube 1222 in any desired direction, such as longitudinally and/or axially. In some examples, the spacing between the nearest adjacent edges of each of openings 1232 can range from about 1.5 mm to about 15 mm. Fluid passes through one or more of perforations, exhaust ports, or openings 1232 into exhaust lumen 1234. Desirably, the openings 1232 are positioned such that they are not occluded by ureteral or renal tissue 1003 when negative pressure is applied to the drainage lumen 1224. For example, as described herein, the openings 1233 can be positioned on an interior portion or protected surface area 1000 of the coil or other structure of the retention portion 1230 to avoid occlusion of the openings 1232, 1233. In some examples, the central portion 1226 and proximal portion 1228 of the tube 1222 are essentially free or devoid of perforations, ports, openings, or apertures to avoid occlusion of the openings along those portions of the tube 1222. In some examples, the portions 1226, 1228 that are essentially devoid of perforations or apertures include substantially fewer openings 1232 than other portions, such as the distal portion 1218 of the tube 1222. For example, the total area of the openings 1232 in the distal portion 1218 may be greater than or substantially greater than the total area of the openings in the central portion 1226 and/or proximal portion 1228 of the tube 1222 .

In some embodiments, the openings 1232 are sized and spaced to improve fluid flow through the retention portion 1230. In particular, the inventors have discovered that when negative pressure is applied to the exhaust lumen 1224 of the catheter 1212, a majority of the fluid is drawn into the exhaust lumen 1224 through the proximal-most perforations or openings 1232. To improve flow dynamics, larger size or greater number of openings 1232 can be provided toward the distal end 1220 of the retention portion 1230 so that fluid is also received through more distal openings and/or through the open distal end 1220 of the tube 1222. For example, the total area of the openings 1232 on the length of the tube 1222 near the proximal end 1228 of the retention portion 1230 may be less than the total area of the openings 1232 on a similarly sized length of the tube 1222 located near the open distal end 1220 of the tube 1222. In particular, it may be desirable to produce a flow distribution through the exhaust lumen 1224 in which less than 90%, preferably less than 70%, and more preferably less than 55% of the fluid flow is drawn into the exhaust lumen 1224 through a single opening 1232 or a small number of openings 1232 positioned near the proximal end 1228 of the retention portion 1230.

In many embodiments, opening 1232 is generally circular in shape, although triangular, oval, square, diamond, and any other opening shape may also be used. Additionally, as will be understood by one skilled in the art, the shape of opening 1232 may change as tube 1222 transitions between the uncoiled or extended position and the coiled or deployed position. It should be noted that while the shape of opening 1232 may vary (e.g., the orifice may be circular in one position and slightly extended in another), the area of opening 1232 is substantially similar in the extended or uncoiled position compared to the deployed or coiled position.
(Spiral coil retention part)

23A-23E, an exemplary retention portion 1230 comprises helical coils 1280, 1282, and 1284. In some embodiments, retention portion 1230 comprises a first or half coil 1280 and two full coils, such as second coil 1282 and third coil 1284. As shown in FIGS. 23A-23D, in some embodiments, first coil 1280 comprises a half coil that extends from 0 degrees to 180 degrees around a curvilinear central axis A of retention portion 1230. In some embodiments, as shown, curvilinear central axis A is substantially straight and coextensive with the curvilinear central axis of tube 1222. In other embodiments, curvilinear central axis A of retention portion 1230 is curved, allowing retention portion 1230 to assume a container shape, for example, a conical shape. The first coil 1280 can have a diameter D12 of approximately 1 mm to 20 mm, preferably approximately 8 mm to 10 mm. The second coil 1282 can be a full coil extending 180 degrees to 540 degrees along the retention portion 1230 and having a diameter D13 of approximately 5 mm to 50 mm, preferably approximately 10 mm to 20 mm, and more preferably approximately 14 mm ± 2 mm. The third coil 1284 can be a full coil extending 540 degrees to 900 degrees and having a diameter D23 of 5 mm to 60 mm, preferably approximately 10 mm to 30 mm, and more preferably approximately 18 mm ± 2 mm. In other embodiments, the multiple coils 1282, 1284 can have the same inner and/or outer diameter. For example, the outer diameter of each of the full coils 1282, 1284 can be approximately 18 mm ± 2 mm.

In some embodiments, the overall height H10 of the retention portion 1230 ranges from about 10 mm to about 30 mm, preferably about 18±2 mm. The height H12 of the gap between adjacent coils 1284, i.e., between the side wall 1219 of the tube 1222 of the first coil 1280 and the adjacent side wall 1221 of the tube 122 of the second coil 1282, is less than 3.0 mm, preferably about 0.25 mm to 2.5 mm, and more preferably about 0.5 mm to 2.0 mm.

The retention portion 1230 may further include a distal-most curved portion 1290. For example, the distal-most portion 1290 of the retention portion 1230, including the open distal end 1220 of the tube 1222, may be curved inward relative to the curvature of the third coil 1284. For example, the curvilinear central axis X1 (shown in FIG. 23D ) of the distal-most portion 1290 may extend from the distal end 1220 of the tube 1222 toward the curvilinear central axis A of the retention portion 1230.

Retention portion 1230 is movable between a retracted position, in which retention portion 1230 is straight for insertion into a patient's urinary tract, and a deployed position, in which retention portion 1230 comprises helical coils 1280, 1282, 1284. Generally, tube 1222 is naturally biased toward the coiled configuration. For example, a non-coiled or generally straight guidewire can be inserted through retention portion 1230 to maintain retention portion 1230 in its straight, retracted position, as shown, for example, in FIGS. 24-27. When the guidewire is removed, retention portion 1230 naturally transitions to its coiled position.

In some embodiments, the openings 1232, 1233 are located essentially only on or only on the radially inward-facing side 1286 or protected or inner surface area 1000 of the coils 1280, 1282, 1284 to prevent blockage or obstruction of the openings 1232, 1233. The radially outward-facing side 1288 of the coils 1280, 1282, 1284 may be essentially free of openings 1232. In similar embodiments, the total area of the openings 1232, 1233 on the inward-facing side 1286 of the retention portion 1230 may substantially exceed the total area of the openings 1232 on the radially outward-facing side 1288 of the retention portion 1230. Thus, when negative pressure is induced within the ureter and/or renal pelvis, ureteral and/or renal mucosal tissue may be drawn against the retention portion 1230 and may occlude some openings 1232 on the outer periphery 1002 or protected surface area 1001 of the retention portion 1230. However, openings 1232 located on the radially inward side 1286 or protected or inner surface area 1000 of the retention portion 1230 are not significantly occluded when such tissue contacts the outer periphery 1002 or protected surface area 1001 of the retention portion 1230. Thus, the risk of tissue injury from entrapment or contact with the drainage openings 1232 can be reduced or eliminated.
(Example of hole or opening distribution)

In some embodiments, the first coil 1280 can be free of, or essentially free of, openings 1232. For example, the total area of the openings 1232 on the first coil 1280 can be less than or substantially less than the total area of the openings 1232 on the complete coils 1282, 1284. Examples of various arrangements of openings or openings 1232 that can be used for a coiled retention portion (such as the coiled retention portion 1230 shown in FIGS. 23A-23E) are illustrated in FIGS. 24-27. As shown in FIGS. 24-27, the retention portion 1330 is depicted in its uncoiled or straight position, such as occurs when a guidewire is inserted through the drainage lumen.

An exemplary retention portion 1330 is illustrated in FIG. 24. To more clearly describe the positioning of the openings in the retention portion 1330, the retention portion 1330 is referred to herein as being divided into multiple sections or perforated sections, such as a proximal-most or first section 1310, a second section 1312, a third section 1314, a fourth section 1316, a fifth section 1318, and a distal-most or sixth section 1320. Those skilled in the art will understand that fewer or additional sections may be included as desired. As used herein, "section" refers to a discrete length of the tube 1322 within the retention portion 1330. In some embodiments, the sections are equal in length. In other embodiments, some sections can have the same length and other sections can have different lengths. In other embodiments, each section has a different length. For example, sections 1310, 1312, 1314, 1316, 1318, and 1320 can each have lengths L11-L16 ranging from about 5 mm to about 35 mm, preferably from about 5 mm to 15 mm.

In some embodiments, each of the sections 1310, 1312, 1314, 1316, 1318, and 1320 includes one or more openings 1332. In some embodiments, each section includes a single opening 1332. In other embodiments, the first section 1310 includes a single opening 1332, and the other sections include multiple openings 1332. In other embodiments, different sections include one or more openings 1332, each with a different shape or total area.

In some embodiments, such as the retention portion 1230 shown in Figures 23A-23E, the first or half coil 1280, which extends from 0 to approximately 180 degrees of the retention portion 1230, can be free of or essentially free of openings. The second coil 1282 can include a first section 1310, which extends from approximately 180 to 360 degrees. The second coil 1282 can also include second and third sections 1312, 1314, which are positioned from approximately 360 to 540 degrees of the retention portion 1230. The third coil 1284 can include fourth and fifth sections 1316, 1318, which are positioned from approximately 540 to 900 degrees of the retention portion 1230.

In some embodiments, the openings 1332 can be sized such that the total area of the openings in the first section 1310 is less than the total area of the openings in the adjacent second section 1312. Similarly, if the retention portion 1330 further comprises a third section 1314, the openings in the third section 1314 can have a total area that exceeds the total area of the openings in the first section 1310 or the second section 1312. The openings in the fourth section 1316, fifth section 1318, and sixth section 1320 may also have gradually increasing total areas and/or numbers of openings to improve fluid flow through the tube 1222.

24, the tube retention portion 1230 includes five sections 1310, 1312, 1314, 1316, and 1318, each including a single opening 1332, 1334, 1336, 1338, and 1340. The retention portion 1330 also includes a sixth section 1320, which comprises the open distal end 1220 of the tube 1222. In this example, the openings 1232 in the first section 1310 have a minimum total area. For example, the total area of the openings 1332 in the first section can range from about 0.002 ^mm to about 2.5 ^mm , or from about 0.01 ^mm to 1.0 ^mm , or from about 0.1 ^mm to 0.5 ^mm . In one example, opening 1332 is approximately 55 mm from the distal end 1220 of the catheter and has a diameter of 0.48 mm and an area of 0.18 ^mm² . In this example, the total area of openings 1334 in second section 1312 exceeds the total area of openings 1332 in first section 1310 and can range in size from approximately 0.01 ^mm² to approximately 1.0 ^mm² . Third opening 1336, fourth opening 1338, and fifth opening 1350 can also range in size from approximately 0.01 ^mm² to approximately 1.0 ^mm² . In one example, second opening 1334 is approximately 45 mm from the distal end of catheter 1220 and has a diameter of approximately 0.58 mm and an area of approximately 0.27 ^mm² . Third opening 1336 is approximately 35 mm from the distal end of catheter 1220 and can have a diameter of approximately 0.66 mm. The fourth opening 1338 can be about 25 mm from the distal end 1220 and have a diameter of about 0.76 mm. The fifth opening 1340 can be about 15 mm from the distal end 1220 of the catheter and have a diameter of about 0.889 mm. In some embodiments, the open distal end 1220 of the tube 1222 has a maximum opening having an area ranging ^from about 0.5 mm to about 5.0 mm or ^greater . In one embodiment, the open distal end 1220 has a diameter of about 0.97 mm and an area of about 0.74 ^mm .

As described herein, the openings 1332, 1334, 1336, 1338, 1340 can be positioned and sized such that when negative pressure is applied to the exhaust lumen 1224 of the catheter 1212, e.g., from the proximal portion 1228 of the exhaust lumen 1224, the volumetric flow rate of fluid passing through the first opening 1332 more closely corresponds to the volumetric flow rate of the openings in the more distal sections. As described above, if each opening is the same area, when negative pressure is applied to the exhaust lumen 1224, the volumetric flow rate of fluid passing through the proximal-most first opening 1332 will substantially exceed the volumetric flow rate of fluid passing through the openings 1334 closer to the distal end 1220 of the retention portion 1330. Without intending to be bound by any theory, it is believed that when negative pressure is applied, the pressure differential between the interior of the exhaust lumen 1224 and the exterior of the exhaust lumen 1224 is greater in the region of the most proximal opening and decreases with each opening moving toward the distal end of the tube. For example, the size and location of the openings 1332, 1334, 1336, 1338, 1340 can be selected so that the volumetric flow rate for fluid flowing into the opening 1334 of the second section 1312 is at least about 30% of the volumetric flow rate for fluid flowing into the opening 1332 of the first section 1310. In other examples, the volumetric flow rate for fluid flowing into the most proximal or first section 1310 is less than about 60% of the total volumetric flow rate for fluid flowing through the proximal portion of the exhaust lumen 1224. In other examples, the volumetric flow rate for fluid flowing through the openings 1332, 1334 of the two most proximal sections (e.g., the first section 1310 and the second section 1312) may be less than about 90% of the volumetric flow rate of fluid flowing through the proximal portion of the exhaust lumen 1224 when a negative pressure, e.g., a negative pressure of about -45 mmHg, is applied to the proximal end of the exhaust lumen.

As will be understood by those skilled in the art, the volumetric flow rate and distribution for a catheter or tube with multiple openings or perforations can be directly measured or calculated in a variety of different ways. As used herein, "volume flow rate" refers to either the actual measurement of the volumetric flow rate downstream and adjacent to each opening or the use of the methods for "calculated volumetric flow rate" described below.

For example, actual measurements of fluid volume dispersed over time can be used to determine the volumetric flow rate through each opening 1332, 1334, 1336, 1338, 1340. In one exemplary experimental arrangement, a multi-chamber container with individual chambers sized to receive sections 1310, 1312, 1314, 1316, 1318, 1320 of retention portion 1330 can be sealed around and enclose retention portion 1330. Each opening 1332, 1334, 1336, 1338, 1340 can be sealed within one of the chambers. The amount of fluid volume drawn from the individual chambers into tube 3222 through each opening 1332, 1334, 1336, 1338, 1340 can be measured to determine the amount of fluid volume drawn into each opening over time when negative pressure is applied. The cumulative fluid volume collected in tube 3222 by the negative pressure pump system will be equal to the sum of the fluid drawn into each opening 1332, 1334, 1336, 1338, and 1340.

Alternatively, the volumetric fluid flow rates through the different openings 1332, 1334, 1336, 1338, and 1340 can be mathematically calculated using equations to model fluid flow through the tubular body. For example, the volumetric fluid flow rates passing through openings 1332, 1334, 1336, 1338, and 1340 into the exhaust lumen 1224 can be calculated based on a mass transfer shell balance evaluation.

Another exemplary retention portion 2230 with openings 2332, 2334, 2336, 2338, and 2340 is illustrated in FIG. 25. As shown in FIG. 25, the retention portion 2230 includes multiple smaller perforations or openings 2332, 2334, 2336, 2338, and 2340. Each of the openings 2332, 2334, 2336, 2338, and 2340 can have substantially the same cross-sectional area, or one or more of the openings 2332, 2334, 2336, 2338, and 2340 can have different cross-sectional areas. As shown in FIG. 25, the retention portion 2330 includes six sections 2310, 2312, 2314, 2316, 2318, and 2320 as described above, with each section including a plurality of openings 2332, 2334, 2336, 2338, and 2340. In the example shown in FIG. 25, the number of openings 2332, 2334, 2336, 2338, and 2340 per section increases toward the distal end 2220 of the tube 2222 such that the total area of the openings 1332 within each section increases compared to the proximally adjacent section.

As shown in FIG. 25 , the openings 2332 in the first section 2310 are aligned along a first imaginary line V1 that is generally parallel to the central axis X1 of the retention portion 2230. The openings 2334, 2336, 2338, and 2340 in the second section 2312, third section 2314, fourth section 2316, and fifth section 2318, respectively, are positioned on the sidewall of the tube 2222 in rows of increasing numbers such that the openings 2334, 2336, 2338, and 2340 in these sections are also aligned around the circumference of the tube 2222. For example, some of the openings 2334 in the second section 2312 are positioned such that a second imaginary line V2 extending around the circumference of the sidewall of the tube 2222 contacts at least a portion of the openings 2334. For example, the second section 2312 can include two or more rows of perforations or openings 2334, with each opening 2334 having an equal or different cross-sectional area. Further, in some examples, at least one of the rows of the second section 2312 can be aligned along a third imaginary line V3 that is parallel to the central axis X1 of the tube 2222 but is not coextensive with the first imaginary line V1. Similarly, the third section 2314 can include five rows of perforations or openings 2336, with each opening 2336 having an equal or different cross-sectional area, the fourth section 2316 can include seven rows of perforations or openings 2338, and the fifth section 2318 can include nine rows of perforations or openings 2340. As in the previous examples, the sixth section 2320 includes a single opening, i.e., the open distal end 2220 of the tube 2222. In the embodiment of FIG. 25, the openings each have the same area, however, the area of one or more openings may vary as desired.

Another exemplary retention portion 3230 with openings 3332, 3334, 3336, 3338, 3340 is illustrated in FIG. 26. The retention portion 3230 of FIG. 26 includes a plurality of similarly sized perforations or openings 3332, 3334, 3336, 3338, 3340. As in the previous example, the retention portion 3230 can be divided into six sections 3310, 3312, 3314, 3316, 3318, 3320, each with at least one opening. The proximal-most or first section 3310 includes one opening 3332. The second section 3312 includes two openings 3334 that are aligned along an imaginary line V2 that extends around the circumference of the sidewall of the tube 3222. The third section 3314 includes a group of three openings 3336 positioned at the vertices of an imaginary triangle. The fourth section 3316 includes a group of four openings 3338 positioned at the corners of an imaginary square. The fifth section 3318 includes ten openings 3340 positioned to form a diamond shape on the sidewall of the tube 3222. As in the previous example, the sixth section 3320 includes a single opening, i.e., the open distal end 3220 of the tube 3222. The area of each opening can range from about 0.001 mm ² to about 2.5 mm ^2. In the example of FIG. 26 , the openings each have the same area, although the area of one or more openings can vary, as desired.

Another exemplary retention portion 4230 with openings 4332, 4334, 4336, 4338, 4340 is illustrated in FIG. 27 . The openings 4332, 4334, 4336, 4338, 4340 of the retention portion 4330 have different shapes and sizes. For example, the first section 4310 includes a single circular opening 4332. The second section 4312 has a circular opening 4334 with a larger cross-sectional area than the opening 4332 of the first section 4310. The third section 4314 includes three triangular openings 4336. The fourth section 4316 includes a large circular opening 4338. The fifth section 4318 includes a diamond-shaped opening 4340. As in the previous example, the sixth section 4320 includes the open distal end 4220 of the tube 4222. 27 illustrates one example of an arrangement of different shaped openings within each section. It should be understood that the shape of each opening within each section can be independently selected, for example, first section 4310 can have one or more diamond-shaped openings or other shapes. The area of each opening can be the same or different and can range from about 0.001 ^mm to about 2.5 ^mm .

28A-50B show additional embodiments of a ureteral catheter 5000 including a retaining portion 5012 for maintaining the distal portion 5004 of the drainage lumen or tube 5002 of the catheter 5000 within the ureter, renal pelvis, and/or kidney. As in the previous embodiments, the retaining portion 5012 can be flexible and/or bendable to allow positioning of the retaining portion 5012 within the ureter, renal pelvis, and/or kidney. For example, the retaining portion 5012 can desirably bend sufficiently to absorb forces exerted on the catheter 5000 and prevent such forces from being transmitted to the ureter. Furthermore, when the retaining portion 5012 is pulled proximally toward the patient's bladder, the retaining portion 5012 can be sufficiently flexible to begin to uncoil, straighten, or collapse so that it can be withdrawn through the ureter.

In some embodiments, the retention portion comprises a funnel-shaped support. Non-limiting examples of different shapes of funnel-shaped supports are shown in Figures 28A-50B, which are discussed in detail below. Generally, the funnel-shaped support comprises at least one sidewall. The at least one sidewall of the funnel-shaped support comprises a first diameter and a second diameter, the first diameter being less than the second diameter. The second diameter of the funnel-shaped support is closer to the end of the distal portion of the drainage lumen than the first diameter.

Now referring to Figures 28A-28D, in some embodiments, the retention portion 5012 comprises a funnel-shaped support 5014. The funnel-shaped support 5014 comprises at least one sidewall 5016. As shown in Figures 28C and 28D, the periphery 1002 or protected surface area 1001 comprises the outer surface or outer wall 5022 of the funnel-shaped support 5014. One or more drain holes, ports, perforations, or interior openings 5030 are disposed on the protected or inner surface area 1000 of the funnel-shaped support 5014. As shown in Figures 28C and 28D, there is a single drain hole 5030 at the base portion 5024 of the funnel-shaped support, although multiple holes may be present.

At least one sidewall 5016 of the funnel-shaped support 5014 has a first (outer) diameter D14 and a second (outer) diameter D15, where the first outer diameter D14 is less than the second outer diameter D15. The second outer diameter D15 of the funnel-shaped support 5014 is closer to the distal end 5010 of the distal portion 5004 of the exhaust lumen 5002 than the first outer diameter D14. In some embodiments, the first outer diameter D14 can range from about 0.33 mm to 4 mm (about 1 Fr to about 12 Fr (French catheter scale)) or about 2.0 ± 0.1 mm. In some embodiments, the second outer diameter D15 exceeds the first outer diameter D14 and can range from about 1 mm to about 60 mm, or from about 10 mm to 30 mm, or about 18 mm ± 2 mm.

In some embodiments, at least one sidewall 5016 of the funnel-shaped support 5014 can further include a third diameter D17 (shown in FIG. 28B), where the third diameter D17 is less than the second outer diameter D15. The third diameter D17 of the funnel-shaped support 5014 is closer to the distal end 5010 of the distal portion 5004 of the exhaust lumen 5002 than the second diameter D15. The third diameter D17 is discussed in more detail below with respect to the periphery. In some embodiments, the third diameter D17 can range from about 0.99 mm to about 59 mm or from about 5 mm to about 25 mm.

At least one sidewall 5016 of the funnel-shaped support 5014 has a first (inner) diameter D16. The first inner diameter D16 is closer to the proximal end 5017 of the funnel-shaped support 5014 than the third diameter D17. The first inner diameter D16 is less than the third diameter D17. In some examples, the first inner diameter D16 can range from approximately 0.05 mm to 3.9 mm or approximately 1.25±0.75 mm.

In some embodiments, the overall height H15 of the sidewall 5016 along the central axis 5018 of the retention portion 5012 can range from about 1 mm to about 25 mm. In some embodiments, the height H15 of the sidewall can vary in different portions of the sidewall, for example, if the sidewall has wavy or rounded edges as shown in FIG. 33A. In some embodiments, the wavy portions can range from about 0.01 mm to about 5 mm or more, as desired.

In some embodiments, as shown in FIGS. 28A-50B, the funnel-shaped support 5014 can have a generally conical shape. In some embodiments, the angle 5020 between the outer wall 5022 near the proximal end 5017 of the funnel-shaped support 5014 and the exhaust lumen 5002 adjacent the base portion 5024 of the funnel-shaped support 5014 can range from about 100 degrees to about 180 degrees, or from about 100 degrees to about 160 degrees, or from about 120 degrees to about 130 degrees. The angle 5020 can vary at different locations around the circumference of the funnel-shaped support 5014, as shown in FIG. 31A, where the angle 5020 ranges from about 140 degrees to about 180 degrees.

In some embodiments, the edge or margin 5026 of the distal end 5010 of at least one side wall 5016 can be rounded, square, or any desired shape. The shape defined by the edge 5026 can be, for example, circular (as shown in FIGS. 28C and 32B), oval (as shown in FIG. 31B), lobed (as shown in FIGS. 37B, 38B, and 40B), square, rectangular, or any desired shape.

Referring now to Figures 37A-40, a funnel-shaped support 5300 is shown having at least one sidewall 5302 comprising multiple leaf-shaped longitudinal folds 5304 along a length L17 of the sidewall 5302. A perimeter 1002 or protected surface area 1001 comprises the outer surface or outer wall 5032 of the funnel-shaped support 5300. One or more drain holes, ports, perforations, or internal openings are disposed on the protected or inner surface area 1000 of the funnel-shaped support 5300. As shown in Figure 37B, there is a single drain hole at the base portion of the funnel-shaped support, although multiple holes may be present.

The number of folds 5304 can range from 2 to about 20 or about 6, as shown. In this example, the folds 5304 are formed from one or more flexible materials, such as silicone, polymer, solid material, fabric, or permeable mesh, to provide the desired leaf-like shape. The folds 5304 can have a generally rounded shape, as shown in the cross-sectional view shown in FIG. 37B. The depth D100 of each fold 5304 at the distal end 5306 of the funnel-shaped support 5300 can be the same or vary and can range from about 0.5 mm to about 5 mm.

38A-38C, one or more of the folds 5304 can include at least one longitudinal support member 5308. The longitudinal support member 5308 can span the entire length L17 of the funnel-shaped support 5300 or a portion of the length L17. The longitudinal support member 5308 can be formed from a flexible yet partially rigid material, such as a temperature-sensitive, shape-memory material, e.g., nitinol. The thickness of the longitudinal support member 5308 can range from about 0.01 mm to about 1 mm, as desired. In some embodiments, the nitinol frame can be coated with a suitable waterproof material, such as silicone, to form a tapered portion or funnel. Fluid is then permitted to flow along the inner surface 5310 of the funnel-shaped support 5300 and into the drainage lumen 5312. In other embodiments, the folds 5304 can be formed from various rigid or partially rigid sheets or materials that are bent or molded to form a funnel-shaped retention portion.

Referring now to Figures 39 and 40, the distal end or edge 5400 of the fold 5402 can include at least one edge support member 5404. The edge support member 5404 can span the entire circumference 5406 of the distal edge 5400 of the funnel-shaped support 5408 or one or more portions of the circumference 5406. The edge support member 5404 can be formed from a flexible yet partially rigid material such as a temperature-sensitive, shape-memory material, e.g., Nitinol. The thickness of the edge support member 5404 can range from about 0.01 mm to about 1 mm, as desired.

In some embodiments, such as those shown in FIGS. 28A-28C, the distal end 5010 of the drain lumen 5002 (or funnel-shaped support 5014) can have an inward-facing rim 5026 oriented toward the center of the funnel-shaped support 5014, e.g., about 0.01 mm to about 1 mm, to prevent inflammation of the kidney tissue. Accordingly, the funnel-shaped support 5014 can have a third diameter D17 that is less than the second diameter D15, the third diameter D17 being closer to the end 5010 of the distal portion 5004 of the drain lumen 5002 than the second diameter D15. The outer surface 5028 of the rim 5026 can be rounded, square-edged, or any desired shape. The rim 5026 can help provide additional support to the renal pelvis and internal kidney tissue.

Referring now to FIGS. 33A and 33B, in some embodiments, the edge 5200 at the distal end 5202 of at least one side wall 5204 can be shaped. For example, the edge 5200 can comprise a plurality of generally rounded edges 5206 or a scalloped shape, e.g., from about 4 to about 20 or more rounded edges. The rounded edges 5206 provide a greater surface area than a straight edge and can help support the renal pelvis or kidney tissue and prevent blockage. The edge 5200 can have any desired shape, but preferably is essentially free of, or absent, sharp edges to avoid injuring tissue.

In some embodiments, such as those shown in Figures 28A-28C and 31A-32B, the funnel-shaped support 5014 includes a base portion 5024 adjacent the distal portion 5004 of the exhaust lumen 5002. The base portion 5024 includes at least one internal opening 5030 aligned with the internal lumen 5032 of the proximal portion 5006 of the exhaust lumen 5002 to allow fluid flow into the internal lumen 5032 of the proximal portion 5006 of the exhaust lumen 5002. In some embodiments, the cross-section of the opening 5030 is circular, although the shape may vary, such as oval, triangular, square, etc.

In some embodiments, such as those shown in Figures 31A-32B, the central axis 5018 of the funnel-shaped support 5014 is offset relative to the central axis 5034 of the proximal portion 5006 of the exhaust lumen 5002. The offset distance X from the central axis 5018 of the funnel-shaped support 5014 relative to the central axis 5034 of the proximal portion 5006 can range from about 0.1 mm to about 5 mm.

At least one internal opening 5030 of the base portion 5024 has a diameter D18 ranging from about 0.05 mm to about 4 mm (e.g., as shown in FIGS. 28C and 32B). In some embodiments, the diameter D18 of the internal opening 5030 of the base portion 5024 is approximately equal to the first inner diameter D16 of the adjacent proximal portion 5006 of the exhaust lumen.

In some embodiments, the ratio of the height H15 of the at least one side wall 5016 of the funnel-shaped support 5014 to the second outer diameter D15 of the at least one side wall 5016 of the funnel-shaped support 5014 ranges from about 1:25 to about 5:1.

In some embodiments, at least one internal opening 5030 of the base portion 5024 has a diameter D18 ranging from about 0.05 mm to about 4 mm, the height H15 of at least one side wall 5016 of the funnel-shaped support 5014 ranging from about 1 mm to about 25 mm, and the second outer diameter D15 of the funnel-shaped support 5014 ranging from about 5 mm to about 25 mm.

In some embodiments, the thickness T11 (e.g., as shown in FIG. 28B) of at least one side wall 5016 of the funnel-shaped support 5014 can range from about 0.01 mm to about 1.9 mm or from about 0.5 mm to about 1 mm. The thickness T11 can be generally uniform throughout the at least one side wall 5016, or can vary as desired. For example, the thickness T11 of the at least one side wall 5016 can be thinner or thicker near the distal end 5010 of the distal portion 5004 of the exhaust lumen 5002 than at the base portion 5024 of the funnel-shaped support 5014.

Referring now to Figures 28A-30, along the length of at least one sidewall 5016, the sidewall 5016 can be straight (as shown in Figures 28A and 29), concave (as shown in Figure 30), or any combination thereof. As shown in Figure 30, the curvature of the sidewall 5016 can be approximated from a radius of curvature R from point Q, such that a circle centered at Q meets the curve and has the same slope and curvature as the curve. In some embodiments, the radius of curvature ranges from about 2 mm to about 12 mm. In some embodiments, the funnel-shaped support 5014 may have a generally hemispherical shape.

In some embodiments, at least one sidewall 5016 of the funnel-shaped support 5014 is formed from a balloon 5100, as shown, for example, in FIGS. 44A, 44B, 47A, and 47B. The balloon 5100 can have any shape that provides funnel-shaped support and prevents obstruction of the ureter, renal pelvis, and/or remnants of the kidney. As shown in FIGS. 44A and 44B, the balloon 5100 has a funnel shape. The balloon can be inflated after insertion or deflated before removal by adding or removing gas or air through the gas port 5102. The gas port 5102 can simply be continuous with the interior 5104 of the balloon 5100; for example, the balloon 5100 can surround the exterior 5108 adjacent the interior 5106 or adjacent the proximal portion 5006 of the drainage lumen 5002. The diameter D19 of the sidewall 5110 of the balloon 5100 can range from about 1 mm to about 3 mm and can vary along its length such that the sidewall has a uniform diameter, tapers toward the distal end 5112 of the funnel-shaped support 5116, or tapers toward the proximal end 5114 of the funnel-shaped support 5116. The outer diameter D20 of the distal end 5112 of the funnel-shaped support 5116 can range from about 5 mm to about 25 mm.

In some embodiments, at least one side wall 5016 of the funnel-shaped support 5014 is continuous along a height H15 of the at least one side wall 5016, as shown, for example, in FIGS. 28A, 29, and 30. In some embodiments, at least one side wall 5016 of the funnel-shaped support 5014 comprises a solid wall, e.g., the side wall 5016 is not permeable through the side wall after 24 hours of contact with a fluid, such as urine, on one side.

In some embodiments, at least one sidewall of the funnel-shaped support is interrupted along the height or body of the at least one sidewall. As used herein, "intermittent" means that at least one sidewall comprises at least one opening for permitting fluid or urine flow therethrough into the drainage lumen, e.g., by gravity or negative pressure. In some embodiments, the opening can be a conventional opening through the sidewall, or an opening in a mesh material, or an opening in a permeable fabric. The cross-sectional shape of the opening can be circular or non-circular, such as rectangular, square, triangular, polygonal, oval, etc., as desired. In some embodiments, the "opening" is a gap between adjacent coils in a retention portion of a catheter comprising a coiled tube or conduit.

As used herein, "opening" or "pore" refers to a continuous void space or channel through a sidewall, from the outside to the inside of the sidewall, or vice versa. In some examples, each of the at least one opening can have an area, which can be the same or different, and can range from about 0.002 ^mm to about 100 ^mm , or from about 0.002 ^mm to about ¹⁰ mm. As used herein, the "area" or "surface area" or "cross-sectional area" of an opening refers to the smallest or minimum planar area defined by the perimeter of the opening. For example, if an opening is circular and has a diameter of about 0.36 mm (area of 0.1 ^mm ) on the outside of the sidewall, but only a diameter of 0.05 mm (area of 0.002 ^mm ) at some point within the sidewall or on the opposite side of the sidewall, the "area" would be 0.002 ^mm , as this is the smallest or minimum planar area for flow through the opening in the sidewall. If the opening is square or rectangular, the "area" would be the length times the width of the planar area. For any other shape, the "area" can be determined by conventional mathematical calculations well known to those skilled in the art. For example, the "area" of an irregularly shaped opening is found by fitting shapes to fill the planar area of the opening, calculating the area of each shape, and adding the areas of each shape together.

In some embodiments, at least a portion of the sidewall comprises at least one opening. Generally, the central axis of the opening can be approximately perpendicular to the planar outer surface of the sidewall, or the opening can be angled relative to the planar outer surface of the sidewall. The bore dimensions of the opening can be uniform throughout its depth, or the width can vary along the depth by either increasing, decreasing, or alternating width from the outer surface of the sidewall through the opening to the inner surface of the sidewall.

22A-22E, 23A, 23E, 24-27, 36, 41A, 41B, 42, and 43, in some embodiments, at least a portion of the sidewall comprises at least one opening(s). The opening(s) can be positioned anywhere along the sidewall. For example, the openings can be positioned uniformly throughout the entire sidewall, or within defined regions of the sidewall, such as closer to the distal end of the sidewall or closer to the proximal end of the sidewall, or positioned vertically, horizontally, or in random groups along the length or circumference of the sidewall. Without intending to be bound by any theory, it is believed that when negative pressure is applied to the proximal end of the proximal portion of the drainage lumen, an opening in the proximal portion of the funnel-shaped support directly adjacent to the ureter, renal pelvis, and/or other renal tissue may be undesirable because such an opening would reduce the negative pressure at the distal portion of the ureteral catheter, thereby reducing the withdrawal or flow of fluid or urine from the kidney and renal pelvis, and possibly inflaming the tissue.

The number of openings can vary from 1 to 1,000 or more, as desired. For example, six openings (three on each side) are shown in Figure 36. As discussed above, in some embodiments, at least one opening can each have an area that can be the same or different and can range from about 0.002 ^mm to about 50 ^mm or from about 0.002 ^mm to about 10 ^mm .

In some embodiments, as shown in FIG. 36 , the openings 5500 can be positioned closer to the distal end 5502 of the side wall 5504. In some embodiments, the openings are positioned in the distal half 5506 of the side wall toward the distal end 5502. In some embodiments, the openings 5500 are evenly distributed around the circumference of the distal half 5506 or even closer to the distal end 5502 of the side wall 5504.

In contrast, in FIG. 41B, the opening 5600 is positioned near the proximal end 5602 of the inner sidewall 5604 and does not directly contact the tissue because the outer sidewall 5606 is between the opening 5600 and the tissue. Alternatively, or in addition, one or more openings 5600 can be positioned near the distal end of the inner sidewall, as desired. The inner sidewall 5604 and the outer sidewall 5606 can be connected by one or more supports 5608 or ridges that connect the outer side 5610 of the inner sidewall 5604 to the inner side 5612 of the outer sidewall 5606.

In some non-limiting examples, such as those shown in Figures 22A-22E, 23A, 23D-23F, 28B, 28D, 29, 31A, 31B, 32A, 32B, 33A, 33B, 34, 35, 36, 37A, 37B, 38A-38C, 39, 40, 41A, 41B, 42, 43, 44A, 44B, 46B, 46A, 48B, 49A, 49B, 50A, and 50B, the protected surface area or inner surface area 1000 can be established by a variety of different shapes or materials. Non-limiting examples of protected or inner surface areas 1000 include, for example, the inner portions 152b, 5028, 5118, 5310, 5410, 5510, 5616, 5710, 5814, 6004 of funnels 150b, 5014, 5116, 5300, 5408, 5508, 5614, 5702, 5802, 6000, coils 183b, 184b, 185b, 187b, 334b, , 1280, 1282, 1284, inner portions 164b, 166b, 168b, 170b, 338b, 1281, 1283, 1285, inner portions 5902, 6003 of porous material 5900, 6002, inner portions 162b, 5710, 5814 of mesh 5704, 5804, or inner portion 536b of cage 530b with protected drain holes 533b.

In some non-limiting examples, at least one protected drain hole, port, or perforation 133b, 1233 is located on the protected surface area 1000. In response to application of negative pressure therapy through the catheter, the urothelial or mucosal tissue 1003, 1004 conforms or collapses onto the outer periphery 189b, 1002 or protected surface area 1001 of the retention portion 130b, 330b, 410b, 500b, 1230, 1330, 2230, 3230, 4230, 5012, 5013 of the catheter, thereby preventing or inhibiting it from occluding one or more of the protected drainage holes, ports, or perforations 133b, 1233 located on the protected or inner surface area 1000, thereby establishing, maintaining, or improving a patent fluid column or flow between the renal pelvis and calyces and the drainage lumen 124b, 324b, 424b, 524b, 1224, 5002, 5003, 5312, 5708, 5808.

In some embodiments, the retention portion 130b, 330b, 410b, 500b, 1230, 1330, 2230, 3230, 4230, 5012, 5013 comprises one or more helical coils having an outward-facing side 1288 and an inward-facing side 1286, the outer periphery 1002 or protected surface area 1001 comprises the outward-facing side 1288 of the one or more helical coils, and at least one protected vent hole, port, or perforation 133b, 1233 is disposed on the inward-facing side 1286 (protected surface area or inner surface area 1000) of the one or more helical coils.

For example, a funnel shape as shown in FIG. 34 can create a sidewall 5700 that conforms to the natural anatomical shape of the renal pelvis and prevents the urothelium from constricting the fluid column. The interior 5710 of the funnel-shaped support 5702 provides a protected surface area 1000 having openings 5706 therethrough that provide a passageway through which the fluid column may flow from the calyces into the drainage lumen 5708. Similarly, the mesh configuration of FIG. 35 can also create a protected surface area 1000, such as the interior 5814 of the mesh 5804, between the calyces and the catheter's drainage lumen 5808. The meshes 5704, 5804 include a plurality of openings 5706, 5806 therethrough to allow fluid flow into the drainage lumen 5708, 5808. In some examples, the maximum area of the openings can be less than about 100 mm ² , or less than about 1 mm ² , or from about 0.002 mm ² to about 1 mm ² , or from about 0.002 mm ² to about 0.05 mm ^2. Mesh 5704, 5804 can be formed from any suitable metal or polymeric material as discussed above.

In some embodiments, the funnel-shaped support further comprises a cover portion over the distal end of the funnel-shaped support. This cover portion can be formed as an integral part of the funnel-shaped support or can be connected to the distal end of the funnel-shaped support. For example, as shown in FIG. 35 , the funnel-shaped support 5802 comprises a cover portion 5810 that traverses and protrudes from the distal end 5812 of the funnel-shaped support 5802. The cover portion 5810 can have any desired shape, such as flat, convex, concave, wavy, and combinations thereof. The cover portion 5810 can be formed from a mesh or any polymeric solid material, as discussed above. The cover portion 5810 provides a perimeter 1002 or protective surface area 1001 to support soft tissue in the renal region and help promote urine production.

In some embodiments, the funnel-shaped support is comprised of a porous material, as shown, for example, in Figures 48A-49B. Figures 48A-49B and suitable porous materials are discussed in detail below. Briefly, in Figures 48A-49B, the porous material itself is the funnel-shaped support. In Figures 48A and 48B, the funnel-shaped support is a wedge of porous material. In Figures 49A and 49B, the porous material is funnel-shaped. In some embodiments, such as Figure 42, the porous material 5900 is positioned within an interior 5902 of a sidewall 5904. In some embodiments, such as Figure 43, the funnel-shaped support 6000 comprises a porous liner 6002 positioned adjacent an interior 6004 of a sidewall 6006. The thickness T12 of the porous liner 6002 can range, for example, from about 0.5 mm to about 12.5 mm. The area of the openings in the porous material can be from about 0.002 mm ² to about 100 mm ² or less.

46A and 46B, for example, the retention portion 130b of the ureteral catheter 112b, in some embodiments, comprises a catheter tube 122b having a flared and/or tapered distal end portion configured to be positioned within a patient's renal pelvis and/or kidney. For example, the retention portion 130b may be a funnel-shaped structure comprising an outer surface 185b configured to be positioned against the ureter and/or kidney wall and an inner surface 186b configured to direct fluid toward the drainage lumen 124b of the catheter 112b. The retention portion may be configured as a funnel-shaped support having an outer surface 185b and an inner surface 186b, wherein the periphery 189b or protective surface area 1001 comprises the outer surface 185b of the funnel-shaped support, and one or more drainage holes, ports, or perforations 133b, 1233 are disposed on the inner surface 186b at the base of the funnel-shaped support. In another embodiment shown in FIGS. 41A and 41B, the retention portion can be configured as a funnel-shaped support 5614 having an outer surface and an inner surface 5616, with the perimeter 1002 or protected surface area 1001 comprising the outer surface of the outer sidewall 5606. The protected surface area 1000 can comprise the inner sidewall 5604 of the inner funnel, and one or more drain holes, ports, or perforations 5600 can be disposed on the inner sidewall 5604 of the funnel-shaped support.

46A and 46B, the retention portion 130b can include a proximal end 188b adjacent the distal end of the exhaust lumen 124b and having a first diameter D11, and a distal end 190b having a second diameter D12 that is greater than the first diameter D11 when the retention portion 130b is in its deployed position. In some embodiments, the retention portion 130b can be transitionable from a collapsed or compressed position to a deployed position. For example, the retention portion 130b can be biased radially outward such that the retention portion 130b (e.g., a funnel portion) expands radially outward to the deployed state when the retention portion 130b is advanced to its fluid collection position.

The retention portion 130b of the ureteral catheter 112b can be made from a variety of suitable materials capable of transitioning from a collapsed state to an expanded state. In one embodiment, the retention portion 130b comprises a framework of tines or elongated members formed from a temperature-sensitive, shape-memory material, such as nitinol. In some embodiments, the nitinol frame can be coated with a suitable waterproof material, such as silicone, to form a tapered portion or funnel. Fluid is then permitted to flow along the inner surface 186b of the retention portion 130b and into the drainage lumen 124b. In other embodiments, the retention portion 130b is formed from a variety of rigid or partially rigid sheets or materials that are bent or molded to form a funnel-shaped retention portion, as shown in FIGS. 46A and 46B.

In some examples, the retention portion of the ureteral catheter 112b can include one or more mechanical stimulation devices 191b for providing stimulation to nerve and muscle fibers within adjacent tissues of the ureter and renal pelvis. For example, the mechanical stimulation device 191b can include a linear or annular actuator embedded within or mounted adjacent to a portion of the sidewall of the catheter tube 122b and configured to emit low-level vibrations. In some examples, the mechanical stimulation can be provided to a portion of the ureter and/or renal pelvis to complement or modify the therapeutic effects achieved by the application of negative pressure. While not intending to be bound by theory, such stimulation is believed to affect adjacent tissues, for example, by stimulating nerves and/or activating peristaltic muscles associated with the ureter and/or renal pelvis. Nerve stimulation and muscle activation can result in changes in pressure gradients or pressure levels within surrounding tissues and organs, which can contribute to, or in some cases enhance, the therapeutic benefits of negative pressure therapy.

47A and 47B, according to another embodiment, the retention portion 330b of the ureteral catheter 312b comprises a catheter tube 322b having a distal portion 318b formed into a helical structure 332b and an expandable element or balloon 350b positioned proximal to the helical structure 332b to provide additional retention within the renal pelvis and/or fluid collection site. The balloon 350b can be inflated to a pressure sufficient to retain the balloon within the renal pelvis or ureter, but low enough to avoid distension or damage to these structures. Suitable inflation pressures are known to those skilled in the art and can be readily determined by trial and error. As in the previously described embodiments, the helical structure 332 can be imparted by bending the catheter tube 322b to form one or more coils 334b. The coils 334b can have constant or variable diameters and heights, as described above. The catheter tube 322b further includes a plurality of drain ports 336b disposed on the sidewall of the catheter tube 322b that allow urine to be drawn into the drain lumen 324b of the catheter tube 322b and directed from the body through the drain lumen 324b, for example, on the inward-facing and/or outward-facing sides of the coil 334b.

As shown in FIG. 47B , the expandable element or balloon 350b can comprise, for example, an annular balloon-like structure having a generally heart-shaped cross-section and a surface or cover 352b defining a cavity 353b. The cavity 353b is in fluid communication with an inflation lumen 354b extending parallel to the drainage lumen 324b defined by the catheter tube 322b. The balloon 350b can be configured to be inserted into the tapered portion of the renal pelvis and inflated such that its outer surface 356b contacts and rests against the inner surface of the ureter and/or renal pelvis. The expandable element or balloon 350b can include a tapered inner surface 358b extending longitudinally and radially inward toward the catheter tube 322b. The inner surface 358b can be configured to direct urine toward the catheter tube 322b and into the drainage lumen 324b. The inner surface 358b can also be positioned to prevent fluid from pooling within the ureter, such as around the periphery of the expandable element or balloon 350b. The expandable retention portion or balloon 350b is desirably sized to fit within the renal pelvis and can have a diameter ranging from about 10 mm to about 30 mm.

Referring to Figures 48A-49B, in some embodiments, the retention portion 410b is comprised of a porous and/or sponge-like material attached to the distal end 421b of the catheter tube 422b. The porous material can be configured to transport and/or absorb urine and direct it toward the drainage lumen 424b of the catheter tube 422b. The retention portion 410b can be configured as a funnel-shaped support having an outer surface and an inner surface, where the perimeter 1002 or protective surface area 1001 comprises the outer surface of the funnel-shaped support, and one or more drainage holes, ports, or perforations in the porous material can be located within the porous material or on the inner surface 426b of the funnel-shaped support.

As shown in FIGS. 49A and 49B, the retention portion 410b can be a porous, wedge-shaped structure configured for insertion and retention within a patient's renal pelvis. The porous material comprises a plurality of pores and/or channels. Fluid can be drawn through the channels and pores, for example, by gravity or in response to the induction of negative pressure through the catheter 412b. For example, fluid can enter the wedge-shaped retention portion 410b through the pores and/or channels and be drawn toward the distal opening 420b of the drainage lumen 424b, for example, by capillary action, peristalsis, or as a result of the induction of negative pressure within the pores and/or channels. In another example, as shown in FIGS. 49A and 49B, the retention portion 410b comprises a hollow funnel structure formed from a porous sponge-like material. As indicated by arrow A, fluid is directed along the inner surface 426b of the funnel structure into the drainage lumen 424b defined by the catheter tube 422b. Fluid can also enter the funnel structure of the retention portion 410b through pores and channels in the porous sponge-like material of the sidewall 428b. For example, a suitable porous material can include an open-cell polyurethane foam, such as polyurethane ether. Suitable porous materials can also include laminates of woven or nonwoven layers of fabric, for example, polyurethane, silicone, polyvinyl alcohol, cotton, or polyester, with or without antimicrobial additives, such as silver, and with or without additives to modify the material properties, such as hydrogel, hydrocolloid, acrylic, or silicone.

50A and 50B , according to another embodiment, the retention portion 500b of the ureteral catheter 512b includes an expandable cage 530b. The expandable cage 530b includes one or more longitudinally and radially extending hollow tubes 522b. For example, the tubes 522b can be formed from a resilient shape-memory material such as Nitinol. The cage 530b is configured to transition from a contracted state for insertion through a patient's urinary tract to an expanded state for positioning within the patient's ureter and/or kidney. The hollow tubes 522b include multiple exhaust ports 534b, which can be positioned thereon, for example, on their radially inward-facing sides. The ports 534b are configured to allow fluid to flow or be drawn into the individual tubes 522b through the ports 534b. Fluid is exhausted through the hollow tubes 522b into an exhaust lumen 524b defined by the catheter body 526b of the ureteral catheter 512b. For example, fluid can flow along the path indicated by arrow 532b in Figures 50A and 50B. In some examples, when negative pressure is induced within the renal pelvis, kidney, and/or ureter, a portion of the ureteral wall and/or renal pelvis can be drawn against the outward-facing surface of hollow tube 522b. Evacuation port 534b is positioned and configured so as not to be significantly obstructed by ureteral structures in response to the application of negative pressure to the ureter and/or kidney.
Coated and/or Impregnated Ureteral Catheters

With reference to Figures 51-54, in some embodiments, at least a portion or all of the devices, such as any or all of the catheters and/or outflow catheters described herein, can be coated and/or impregnated with at least one of the coating/impregnation materials described herein. ... catheters, generally collectively designated as 7010, described herein can be coated and/or impregnated with at least one of the coating/impregnation materials described herein.

In some examples, the device 7010 can be configured to facilitate insertion and/or removal of the coated device 7010 within a patient's urinary tract and/or at least one coating and/or impregnation 7022 can improve the function of the device 7010 once inserted. The device 7010 can be configured for insertion into one or more of the patient's ureter, renal pelvis, and/or kidney. The device 7010 can be deployed to maintain the end 7044 or retention portion 7020 of the device 7010 at a desired location within the urinary tract. The device 7010 can be sized to fit securely at a desired location within the urinary tract, as described in detail herein. The device 7010 can be sufficiently narrow in the retracted state so that the coated device 7010 can be easily inserted and removed. The device 7010 can have any of the configurations described herein, e.g., a catheter or a stent. In some embodiments, the retention portion 7020 of a suitable catheter comprises a funnel, a coil, a balloon, a cage, a sponge, and/or combinations thereof.

The device 7010 to be coated and/or impregnated can be formed or consist of at least one device material, such as copper, silver, gold, nickel-titanium alloy, stainless steel, titanium, and/or at least one biocompatible polymer, such as polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicon-coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone, and/or poly(propylene fumarate), as discussed in detail above.

In some examples, at least one coating and/or impregnation 7022 may be present on and/or within at least the outer periphery 1002 or protective surface area 1001, 7038 of the device 7010 that inhibits the mucosal tissue 1003 from occluding the at least one protected drainage hole, port, or perforation 7036 in response to application of negative pressure through the catheter. In some examples, at least one coating and/or impregnation 7022 may be present on and/or within any portion of the device 7010 and/or on and/or within the entire device 7010. In some examples, at least one coating and/or impregnation 7022 may be present on and/or within at least a portion of the retention portion 7020 or on and/or within the entire retention portion 7020. In some examples, at least one coating and/or impregnation 7022 may be present on and/or within at least a portion of the surface of the device or on and/or within the entire surface of the device. In some examples, at least one coating and/or impregnation 7022 may be present on and/or within at least the outer surface 7028 of the device, or on and/or within the entire outer surface 7028 of the device. In some examples, at least one coating and/or impregnation 7022 may be present on and/or within other portions of the device 7010, such as some or all of the delivery catheter of any of the catheter assemblies described above. In some examples, the at least one coating and/or impregnation 7022 is formed from one or more flexible coating materials that do not significantly or substantially affect the flexibility of the coated and/or impregnated device 7010.

In some examples, the at least one coating 7022 can comprise one or more coatings, e.g., 1-10 coatings, or 2-4 coatings. In some examples, the material from which the device 7010 is formed (the device material discussed herein) can be coated with at least one of the coating/impregnation materials discussed herein. The coating 7022 may be applied or formed in layers, with the understanding that components of one coating layer may potentially migrate into one or more adjacent or neighboring layers and/or onto the surface or within the device 7010.

In some embodiments, the material from which the device 7010 is formed (the device material discussed herein) can be impregnated with at least one of the coating/impregnation materials discussed herein. As used herein, "impregnated" means that at least a portion of the coating/impregnation material discussed herein penetrates beneath and/or within at least a portion of the outer surface of the device material from which the device 7010 is formed. In some embodiments, different coating/impregnation materials and/or different amounts of individual coating/impregnation materials discussed herein can be used to impregnate different portions or regions of the device 7010. For example, the retention portion 7020 can be impregnated with at least one of the coating/impregnation materials described herein, such as at least one lubricating material and/or at least one antibacterial material, while the drain tube is impregnated only with at least one antibacterial material. Some or all of the device 7010 can be both impregnated and/or coated, as desired. In some embodiments, different layers of impregnation can be present at different depths within the device 7010.

At least one coating/impregnation material (which may be used as a coating material and/or an impregnation material, referred to for brevity as a "coating/impregnation material") comprises at least one (one or more) of a lubricant, an antibacterial material, a pH buffer, or an anti-inflammatory material. In some embodiments, at least one coating and/or impregnation 7022 can be used to improve the short- or long-term performance of the device 7010, reduce pain during insertion/removal of the device 7010 into the urinary tract, and/or mitigate risks associated with long-term use of an indwelling device.

For example, at least a portion of the device 7010 can be coated and/or impregnated with at least one coating/impregnation material comprising at least one lubricant. The at least one coating and/or impregnation 7022 comprising at least one lubricant can, for example, have a lower coefficient of friction than a device that is not coated/impregnated, function as a lubricant, and/or become lubricated or slippery in the presence of fluids such as moisture or urine. The presence of a lubricant in the at least one coating and/or impregnation 7022 can make the device 7010 easier to deploy and remove. Generally, in some examples, the at least one coating and/or impregnation 7022 can be comprised of a material configured to address sources of problems and discomfort associated with indwelling catheters.

Alternatively, or in addition, the device 7010 can be coated and/or impregnated with at least one of an antibacterial material, a pH buffer, and/or an anti-inflammatory material. The at least one of the antibacterial material, the pH buffer, and/or the anti-inflammatory material can mitigate risks associated with long-term use of indwelling catheters, such as tissue ingrowth through portions of the device, foreign body reactions caused when portions of the device contact surrounding fluids and/or tissues, infection of tissues surrounding the device, and/or the formation of encrustations on portions of the device. Encrustations can be caused, for example, by protein adsorption and/or the accumulation of minerals or urinary crystals.

In some embodiments, at least one coating and/or impregnation 7022 comprises at least one lubricant. In some embodiments, the outer surface or layer of at least one coating and/or impregnation 7022 comprises at least one lubricant. Lubricious coatings/impregnations can be described in terms of their degree of lubricity or dynamic coefficient of friction, or the amount of friction reduction they provide compared to an uncoated device or a device comprising one or more coatings/impregnations having an outer layer with a dynamic coefficient of friction that exceeds the dynamic coefficient of friction of a comparable lubricant-coated device. The dynamic coefficient of friction can be determined using ASTM Method D1894-14 (March 2014). A rigid mandrel can be inserted through the inner lumen of the stent/catheter section being inspected, sized to minimize the amount of open space inside the stent/catheter inner lumen and any potential resulting contraction of the inner lumen as the thread is dragged along the material. Alternatively, the catheter tubing can be slit into a flat sheet for inspection and opened.

In some embodiments, the lubricant can comprise at least one hydrophilic lubricating material. Exemplary hydrophilic lubricating materials include at least one of polyethylene glycol, polyvinylpyrrolidone, polytetrafluoroethylene, polyvinyl alcohol, polyacrylamide, polymethacrylic acid, and other acrylic polymers or copolymers of the materials listed above, or polyelectrolytes. An exemplary hydrophilic coating material/impregnation is ComfortCoat® polyelectrolyte-containing hydrophilic coating, available from Koninklijke DSM N.V. Examples of suitable hydrophilic coating/impregnation materials comprised of polyelectrolytes are disclosed in U.S. Pat. No. 8,512,795, incorporated herein by reference.

In some embodiments, at least one coating/impregnation 7022 can be comprised of at least one material that is not hydrophilic. For example, one or more layers of at least one coating and/or impregnation 7022 can be comprised of or formed of polytetrafluoroethylene (e.g., Teflon), siloxane, silicone, or polysiloxane, or other slippery and/or low-friction material.

In some embodiments, the lubricant can be comprised of at least one polymeric material, such as an at least partially crosslinked polymeric material (e.g., a gel or hydrogel). In some embodiments, the at least one polymeric material readily captures or entrains fluids or liquids. A gel or hydrogel is a system comprised of a three-dimensional, physically or chemically bonded polymer network that entrains fluids or liquids, such as water, within the intermolecular spaces. As known in the art, a gel or hydrogel can refer to an at least partially crosslinked material that is comprised of a substantial liquid portion but exhibits little or no flow when in a steady state. By weight, gels are generally mostly liquid, but can behave like solids due to their crosslinked structure. Due to their ability to accommodate high water content, porosity, and soft consistency, hydrogels closely simulate natural biological tissues. Gels and hydrogels can be chemically stable, or they can degrade and eventually disintegrate and dissolve. In some embodiments, the at least one lubricant is biocompatible.

For example, useful gels or hydrogels can be composed of one or more of polyethylene glycol, polyvinylpyrrolidone, polytetrafluoroethylene, polyvinyl alcohol, polyacrylamide, polymethacrylic acid, and/or hydrogels composed of polyacrylic acid (PAA), and/or disulfide cross-linked poly(oligo(ethylene oxide) monomethyl ether methacrylate) (POEMA). As a result of capturing or incorporating a fluid (such as water), some hydrophilic materials can become gel-like, smooth, and/or lubricious.

Thus, when in the presence of fluid (such as water and/or urine), the hydrophilic material of the lubricant can provide increased lubricity between the stent or catheter device 7010 and adjacent portions of the patient's urinary tract.

Combinations or mixtures of hydrophilic lubricating materials, non-hydrophilic lubricating materials, and/or polymeric lubricating materials can be used in the same coating/impregnation or different coatings/impregnations or layers thereof, as desired. In some examples, the concentration of at least one lubricant in at least one coating and/or impregnation 7022 prior to drying or curing can range from about 0.1 to about 99.9 weight percent or 100 weight percent, or from about 20 to 100 weight percent, or from about 50 to about 100 weight percent, based on the total weight of the coating/impregnation material composition. In some examples, the concentration of at least one lubricant in at least one coating and/or impregnation 7022 after drying or curing can range from about 0.1 to about 99.9 weight percent, or 100 weight percent, or from about 20 to 100 weight percent, or from about 50 to about 100 weight percent, based on the total weight of the dried or cured coating/impregnation.

In some examples, at least one coating and/or impregnation 7022 can comprise at least one antimicrobial material, for example, to inhibit tissue growth and/or prevent infection. For example, at least one coating and/or any of the impregnations 7022, such as the outermost layer 7024 and/or any of the sub-layers 7026, can comprise at least one antimicrobial material itself or one or more materials comprising at least one antimicrobial material, for example, a polymeric matrix formed from a suitable biocompatible material impregnated with an antimicrobial material. Alternatively, or in addition, the sub-layer 7026 can comprise a liposome coating or similar material and can be configured to deliver a bacteriophage or drug therapy. An antimicrobial material can refer to, for example, at least one of a bactericidal material, an antiviral material, an antibacterial material, an antifungal material, and/or an antibiotic material, such as an antibiotic drug or therapeutic. Examples of suitable antibacterial, antifungal, and/or antiseptic agents and materials can include chlorhexidine, silver ions, nitric oxide, bacteriophages, sirolimus, and/or sulfonamides. Some antibacterial materials, such as sirolimus, can also act as immunosuppressants to reduce foreign body responses elicited by indwelling catheters. Examples of suitable antibiotic materials that can be included in the at least one coating and/or impregnation ⁷⁰²² can include amdinocillin, levofloxacin, penicillin, tetracycline, sparfloxacin, and/or vancomycin. The dose or concentration of such antibacterial agents can be selected to avoid or reduce the incidence of infection as known to those skilled in the art, such as from about 1 to about 100 mcg/cm3. The antimicrobial and/or antibacterial material of the coating can also be comprised of materials such as heparin, phosphorylcholine, silicon dioxide, and/or diamond-like carbon to inhibit any of protein adsorption, biofilm formation, mineral and/or crystal accumulation, and similar risk factors. Other suitable antimicrobial materials that provide useful functional properties for the coating can be comprised of other antimicrobial peptides, caspofungin, chitosan, parylene, and organosilanes, as well as other materials that impart mechanical antimicrobial properties.

In some examples, the concentration of the at least one antimicrobial material in the at least one coating and/or impregnation 7022 prior to drying or curing can range from about 0.1 to about 99.9 weight percent or 100 weight percent, or from about 20 to 100 weight percent, or from about 50 to about 100 weight percent based on the total weight of the coating/impregnation material composition. In some examples, the concentration of the at least one antimicrobial material in the at least one coating and/or impregnation 7022 after drying or curing can range from about 0.1 to about 99.9 weight percent or 100 weight percent, or from about 20 to 100 weight percent, or from about 50 to about 100 weight percent based on the total weight of the dried or cured coating/impregnation.

In some embodiments, the at least one coating and/or impregnation 7022 of antimicrobial material should provide suitable protection for the coated device 7010 throughout the lifetime of the device 7010, although the time period over which the antimicrobial properties are present may be shorter. Thus, the at least one coating and/or impregnation 7022 should be sufficiently thick and contain sufficient antimicrobial material to continue to exhibit antimicrobial properties throughout the lifetime of the coated device 7010, which may be from about 1 day to about 1 year, or from about 10 days to about 180 days, or from about 30 days to about 90 days.

In some embodiments, alternatively or additionally, at least one coating and/or impregnation 7022 can comprise at least one pH buffering material for buffering the pH of fluids within the urinary tract, such as urine. Such buffering materials can, for example, reduce or eliminate encrustation that may adhere to the surface of the coated device 7010. It is believed that pH buffering materials often reduce encrustation by inhibiting or preventing the formation of urinary crystals that adhere to indwelling structures positioned within the urinary tract. For example, in the presence of organisms capable of producing the urease enzyme, a local increase in ammonium concentration and pH can result in the formation of crystals of at least one of calcium phosphate, magnesium phosphate, or ammonium magnesium phosphate, while urate and oxalate crystals are more commonly seen with decreasing pH levels. The pH of urine can range from about 4.5 to about 8.0, typically about 6.0.

When the pH of the fluid in the urinary tract rises above a predetermined value, such as 6.0 or 7.0, the at least one coating and/or impregnation 7022 can release some or all of the at least one buffering material into the fluid. Alternatively, or in addition, when the pH of the fluid in the urinary tract falls below a predetermined value, such as 5.5 or 6.0, the at least one coating and/or impregnation 7022 can release some or all of the at least one buffering material into the fluid. Alternatively, or in addition, the at least one coating and/or impregnation 7022 can release some or all of the at least one buffering material into the fluid when the concentration of at least one of calcium, magnesium, phosphorus, oxalate, or uric acid reaches a predetermined value. For example, in a patient with elevated levels of at least one of calcium, magnesium, phosphorus, oxalate, or uric acid in their fluid or urine, the at least one coating and/or impregnation 7022 may release some or all of the at least one buffering material into the fluid. Examples of suitable predetermined values for the analytes are at least about 15 mg/deciliter (dl) for calcium, at least about 9 mg/dl for magnesium, at least about 60 mg/dl for phosphorus, at least about 1.5 mg/dl for oxalate, and at least about 36 mg/dl for uric acid. Calcium, specifically, is commonly referred to as a ratio to urinary creatinine; i.e., a normal value would be urinary calcium:urinary creatinine <0.14. Levels of these analytes in the fluid or urine can be determined using one or more of colorimetric, spectroscopic, or microscopic methods of examination of the fluid or urine sample. "Normal" values and reference ranges are often provided in units of "mg/24 hours" because excretion is highly driven by dietary intake and would therefore be expected to be variable over time. Excretion of these analytes can also be significantly affected by the use of certain medications, such as diuretics. The device can essentially "sense" and respond to analyte levels by releasing one or more buffering agents as a result of analyte binding to at least a portion or component of the coating layer. Predetermined thresholds can be established for specific analytes to determine the binding affinity of the coating layer, such that different levels of binding will trigger the release of various amounts of one or more buffering agents, as desired.

An example of a suitable pH buffering material can comprise, for example, an acid salt impregnated into a dissolvable polymeric material layer. As will be understood by those skilled in the art, as the acid salt dissolves in the presence of body fluids or moisture, an acidic solution is produced. Desirably, the acidic solution produced is acidic enough to prevent encrustation but not so acidic that it damages bodily tissue. An example of a suitable acid salt that can be used as a suitable pH buffering layer can comprise a weak acid salt, such as sodium citrate, sodium acetate, and/or sodium bicarbonate. In some examples, the pH buffering material can be dispersed within a hydrogel, colloid, and/or copolymer matrix, such as a methacrylic acid and methyl methacrylate copolymer, and dispersed or layered with a high affinity calcium or phosphate binder, such as ethylene glycol tetraacetic acid (EGTA).

In some examples, the concentration of the at least one pH buffer material in the at least one coating and/or impregnation 7022 prior to drying or curing can range from about 0.1 to about 99.9 weight percent or 100 weight percent, or from about 20 to 100 weight percent, or from about 50 to about 100 weight percent based on the total weight of the coating/impregnation material composition. In some examples, the concentration of the at least one pH buffer material in the at least one coating and/or impregnation 7022 after drying or curing can range from about 0.1 to about 99.9 weight percent or 100 weight percent, or from about 20 to 100 weight percent, or from about 50 to about 100 weight percent based on the total weight of the dried or cured coating/impregnation.

In some embodiments, the at least one coating and/or impregnation 7022 can comprise an outermost layer 7024 and one or more sublayers 7026 (e.g., comprising either an antimicrobial sublayer or a pH buffer sublayer). In other embodiments, the sublayers 7026 of the at least one coating and/or impregnation 7022 can comprise, for example, a first sublayer 7030 applied to the outer surface 7028 of the device 7010, e.g., comprised of a pH buffering material to reduce urinary crystal encrustation, and a second sublayer 7032 covering at least a portion of the first sublayer 7030. The second sublayer 7032 can comprise, for example, an antimicrobial material. Alternatively, the first sublayer 7030 can comprise an antimicrobial material and the second sublayer 7032 can comprise a pH buffering material.

In some embodiments, alternatively or additionally, at least one coating and/or impregnation 7022 can comprise at least one anti-inflammatory material. Following insertion into the body, proteins and other biomolecules within the body, such as those within plasma and biological fluids, are absorbed onto the biomaterial surface of the device or implant. Nonspecific biomolecule and protein adsorption and subsequent leukocyte adhesion, known as "biofouling," can result. Subsequent inflammatory responses, such as biomaterial-mediated inflammation, can result, which is a combined reaction of protein adsorption, leukocyte recruitment/activation, secretion of inflammatory mediators, and fibrous encapsulation of some or all of the device or implant. Reducing the inflammatory response, for example, by reducing protein binding and the ability of an immune response to propagate, can prevent or reduce potential injury to urinary tract tissues due to contact with the device in the absence or presence of negative pressure.

Non-limiting examples of suitable anti-inflammatory materials include anti-inflammatory drugs and non-adherent surface treatment materials. Examples of suitable anti-inflammatory drugs include at least one of dexamethasone (DEX), heparin, or alpha-melanocyte stimulating hormone (α-MSH). Examples of suitable non-adherent surface treatment materials include at least one of polyethylene glycol-containing polymers, poly(2-hydroxyethyl methacrylate), poly(N-isopropylacrylamide), poly(acrylamide), phosphorylcholine-based polymers, mannitol, oligomaltose, or taurine groups.

In some examples, the concentration of the at least one anti-inflammatory material in the at least one coating and/or impregnation 7022 prior to drying or curing can range from about 0.1 to about 99.9 weight percent or 100 weight percent, or from about 20 to 100 weight percent, or from about 50 to about 100 weight percent based on the total weight of the coating/impregnation material composition. In some examples, the concentration of the at least one anti-inflammatory material in the at least one coating and/or impregnation 7022 after drying or curing can range from about 0.1 to about 99.9 weight percent or 100 weight percent, or from about 20 to 100 weight percent, or from about 50 to about 100 weight percent based on the total weight of the dried or cured coating/impregnation.

In some embodiments, the at least one coating and/or impregnation 7022 can comprise an outermost layer 7024 and one or more sublayers 7026 comprised of at least one anti-inflammatory material. In some embodiments, the outermost layer 7024 can comprise at least one pH buffering material, and one or more sublayers 7026 can comprise at least one anti-inflammatory material.

In some examples, the overall thickness of at least one coating and/or impregnation 7022, or the depth of impregnation into the device material, after application and drying and/or curing of the coating/impregnation, can range from about 0.001 micrometer (about 1 nanometer) to about 10.0 millimeters, or from about 0.001 micrometer to about 5 mm, or from about 0.001 mm to about 5.0 mm, or from about 0.01 mm to about 1.0 mm, or from about 0.001 micrometer to about 0.2 mm. In some examples, each coating/impregnation layer within a plurality of coating/impregnation layers can have a thickness after application and drying or curing of the coating/impregnation layer, ranging from about 0.001 micrometer to about 10.0 millimeters, or from about 0.001 micrometer to about 5.0 mm, or from about 0.001 micrometer to about 500 micrometers.

In some examples, the overall thickness of at least one hydrated or expanding coating and/or impregnation 7022, or the depth of impregnation into the device material, can range from about 0.1 micrometer to about 25.0 millimeters, or from about 0.1 micrometer to about 500 micrometers, or about 20 micrometers ±20%.

In some embodiments, the density of the coating/impregnation material composition can range from about 0.1 to about 200 mg/microliter, or about 1 mg/microliter, prior to drying or curing. The coating/impregnation material to be applied to the device 7010 prior to drying or curing can further comprise at least one carrier or adjuvant, such as water, alcohol, silica oil such as polydimethylsiloxane, and/or a polymer matrix material, such as, for example, a hydrogel comprised of polyacrylic acid (PAA) and/or disulfide cross-linked poly(oligo(ethylene oxide) monomethyl ether methacrylate) (POEMA).

In some examples, the concentration of at least one of the lubricant, antimicrobial material, pH buffer, or anti-inflammatory material in the coating/impregnating material composition prior to drying or curing can range from about 0.1 to about 99.9 weight percent or 100 weight percent based on the total weight of the coating/impregnating material composition used in an individual layer. In some examples, the coating/impregnating material composition can be applied to the device 7010 prior to drying or curing in an amount ranging ^from about 0.001 mg/cm to about ⁵ mg/cm or about ² mg/cm ±50% per layer. In some examples, for a coating/impregnating material composition comprising at least one antimicrobial agent, the coating/impregnation can be applied to the device 7010 prior to drying or curing in an amount ranging ^{from about} 0.001 mg/cm to about 5 mg/cm or about ² mg/cm ^± 50%, or about 0.005 mg/cm to about 0.025 mg/cm ^{per layer} .

In some embodiments, the outermost coating/impregnation layer 7024 comprises at least one lubricant. In some embodiments, the at least one lubricant (e.g., a hydrophilic material, gel, or hydrogel) is configured to remain or to at least partially or completely dissipate upon exposure to fluids (e.g., water and/or urine), such as occurs when the catheter device 7010 is deployed within a patient's urinary tract, to reveal or uncover other materials of the at least one coating and/or impregnation 7022 or outer surface 7028 of the catheter device 7010 beneath the lubricant coating. For example, as the lubricant dissipates, one or more sub-layers or underlying layers positioned below the outermost layer 7024 may be exposed. The lubricant of the outermost layer 7024 can be configured to dissipate into the surrounding fluid or tissue within a desired period of time following implantation. Because the lubricant may be intended primarily to facilitate insertion and positioning of the coated device 7010, some or all of the outermost layer 7024 may dissipate within a fairly short period of time following insertion within the urinary tract. For example, the outermost layer 7024 may be configured to completely, substantially, or partially dissipate within 6 hours to 10 days, or 12 hours to 5 days, or 1 day to 3 days following insertion and/or placement within the urinary tract. As used herein, a material such as some or all of the outermost layer 7024 substantially dissipates when at least about 90%, or at least about 95%, or about 95%, or about 98% of the outermost layer 7024 releases from the surface of the catheter 7010 or a coating beneath the outermost layer and is absorbed into the surrounding fluid and/or tissue 1003, 1004 and/or is excreted from the patient's body. In some examples, the outermost layer 7024, which dissipates within 1 to 10 days, can have a total thickness ranging from 0.01 micrometers to 5.0 millimeters, or 0.001 mm to 2.5 mm, or 0.01 mm to 1.0 mm, prior to hydration or activation or upon hydration or activation. In some embodiments, the thickness of the outermost layer 7024 can depend in large part on the length of time the outermost layer 7024 is to remain in place while in the urinary tract before dissolving and exposing the at least one coating and/or impregnation 7022 of the catheter device 7010 and/or sublayer 7026 of the outer surface 7028.

Upon dissipation of the outermost layer 7024, the material of one or more sublayers 7026 positioned below the outermost layer 7024 may remain in place and provide a particular property or function over an extended time period, or may be configured to release into the surrounding fluid and/or tissue, e.g., to provide a desired therapeutic or beneficial effect for the surrounding fluid and/or tissue. For example, the material of one or more sublayers 7026 can be configured for sustained release into the surrounding tissue over a period ranging from about 1 day to about 1 year, or from about 30 days to about 180 days, or from about 45 days to about 90 days. In some examples, the dissipation rate for the sublayer 7026 depends on the thickness of the outermost layer 7024. For example, the sublayer 7026 can have a total thickness ranging from about 0.01 micrometer to 5.0 millimeters, or from about 0.01 mm to 4.0 mm, or from about 0.1 mm to 3.0 mm. In some embodiments, the thickness of the sublayer 7026 can be selected to provide a residual or dissolving and releasing material to improve the function of the catheter device 7010 over its entire life or the time that the device 7010 is in the urinary tract.

In other embodiments, the outermost layer 7024 can be configured to remain attached to the coated device 7010, and in some embodiments, to maintain its beneficial properties throughout part or all of the time period that the coated device 7010 is in the urinary tract. For example, the outermost layer 7024 may remain in place for periods of up to 10 days, 45 days, 90 days, or at least one year when in the patient's urinary tract. To maintain beneficial or hydrophilic properties for at least one year, the outermost layer 7024 may be as thick as 0.01 mm or thinner, or may be thicker than 5.0 mm, possibly up to 10.0 mm thick. Alternatively, or in addition, the outermost layer 7024 can be formed from a material that does not dissolve or degrade, or that degrades only slowly when in the urinary tract. For example, certain slippery or low-friction non-hydrophilic materials, such as polytetrafluoroethylene (PTFE) (e.g., Teflon), may remain in place for extended time periods without dissolving.

When configured to maintain properties such as hydrophilicity over an extended period of time, the outermost layer 7024 can be configured for time-dependent permeability or release such that bulk material of the sublayers 7026 can pass through the outermost layer 7024 to surrounding fluids and/or tissue. For example, the outermost layer 7024 can include structure and/or void spaces to allow moisture or fluid to permeate through the outermost layer 7024 to one or more sublayers 7026. To achieve such permeability, the outermost layer 7024 can be comprised of a composite material, where bulk hydrophilicity is maintained while at least one contributing material of the outermost layer 7024 provides properties such as selective diffusibility, solubility, and/or porosity (e.g., microporosity, mesoporosity, or macroporosity). According to the International Union of Pure and Applied Chemistry (IUPAC) nomenclature, microporous, mesoporous, and macroporous describe materials that exhibit pores with diameters less than 2.0 nanometers, 2.0-50 nanometers, and greater than 50 nanometers, respectively. Processes that can be used to form porous materials can include, for example, phase separation, gas formation, and soft and hard casting techniques, as well as other selective and additive manufacturing methods.

Alternatively, or in addition, as shown diagrammatically in FIG. 53 , the outermost layer 7024 can include at least one opening, hole, space, and/or microchannel 7052 extending through the outermost layer 7024 to one or more sublayers 7026. The at least one opening, hole, space, and/or microchannel 7052 can be inherent, naturally occurring, or generated (artificial) within the material of the outermost layer 7024. For example, the outermost layer 7024 can be inherently porous. In some examples, the at least one opening, hole, space, and/or microchannel can be formed by any suitable process, including, for example, pushing a pin or puncture needle through the hardened outermost layer 7024. In other examples, the at least one opening, hole, space, and/or microchannel 7052 can be formed by etching or dissolving a portion of the outermost layer 7024. The at least one opening, pore, space, and/or microchannel 7052 can be configured to allow fluid, such as moisture, to pass through the outermost layer 7024 to the sublayer 7026, and for dissolved material from the sublayer 7026 to pass to surrounding fluid and/or tissue through the at least one opening, pore, space, and/or microchannel 7052 in the outermost layer 7024. In some examples, the at least one opening, pore, space, and/or microchannel 7052 initially extends entirely through the outermost layer 7024 such that fluid can permeate one or more sublayers 7026 upon positioning the device 7010 in the urinary tract. In other examples, the at least one opening, pore, space, and/or microchannel 7052 may extend partially through the outermost layer 7024. In that case, fluids such as moisture or urine may collect within the at least one opening, pore, space, and/or microchannel 7052 and dissolve a portion of the at least one opening, pore, space, and/or microchannel 7052 during an initial cycle following insertion into the urinary tract. Over time, the at least one opening, pore, space, and/or microchannel 7052 dissolves through the remainder of the outermost layer 7024, eventually contacting and exposing a portion of the one or more sublayers 7026. In this manner, release of the functional material of the sublayer 7026 is delayed until a period of time after the device 7010 is inserted into the urinary tract. The at least one opening, pore, space, and/or microchannel 7052 may be of any size and number sufficient to allow fluids such as moisture to pass through and contact the one or more sublayers 7026, and to allow dissolved material of the sublayer 7026 to pass through the at least one opening, pore, space, and/or microchannel 7052 to surrounding body fluids and tissues. For example, the at least one opening, hole, space, and/or microchannel 7052 can have ^a cross-sectional area of ^about 0.01 micrometers to about 1.0 millimeters, or about 0.1 ^mm to about 0.5 ^mm , or about 0.2 ^mm to about 0.4 ^mm . The at least one opening, hole, space, and/or microchannel 7052 can be formed in or on the outermost layer 7024 in a variety of configurations and arrangements. For example, the at least one opening, hole, space, and/or microchannel 7052 can be a plurality of openings having any desired configuration, e.g., a generally circular, oval, or any shape in cross-section. In other examples, the at least one opening, hole, space, and/or microchannel 7052 can be a trough or hole extending in any direction (e.g., axially and/or circumferentially) along the surface of or within the outermost layer 7024.

As shown in FIGS. 52 and 53 , in some embodiments, a sublayer 7026 is positioned between the outer surface 7028 of the device 7010 (e.g., elongated tube 7012) and the outermost layer 7024. The sublayer 7026 can be configured to improve the long-term performance of the coated device 7010 by addressing one or more of the above-described problems associated with long-term use of the device 7010, such as an indwelling catheter. For example, the one or more sublayers 7026 can improve the long-term performance of the coated device 7010 by one or more of inhibiting tissue ingrowth, mitigating a foreign body reaction with the tissue surrounding the deployed coated device 7010, reducing infection of the tissue surrounding the coated device 7010, and/or reducing urinary crystal encrustation on the coated device 7010.

In some examples, the at least one coating and/or impregnation 7022 is intended to contact a portion of fluid and/or tissue 1003, 1004 surrounding the coated device 7010 that may be brought into contact with the device 7010 by natural forces or applied negative pressure. Thus, the at least one coating and/or impregnation 7022 may need to be applied only to at least a portion or all of the outer periphery 1002, or outward-facing side, or protected surface 1001, 7038, of at least a portion or all of the retaining portion 7020, etc. of the device 7010. In some instances, the inner periphery, inward-facing side, or protected surface area 1001, 7034 of the retaining portion 7020, including at least one protected drain hole, port, or perforation 7036, as described above, may be substantially free or absent of the at least one coating and/or impregnation 7022. Alternatively, as described in connection with FIG. 54, both the protected surfaces 1000, 7034 and the protected surfaces 1001, 7038 of the device 7010 may be coated with at least one coating and/or impregnation 7022, e.g., to provide one or more of the aforementioned benefits of a coating and/or to facilitate manufacturability (e.g., deposition of the coating on the device 7010).

At least one coating and/or impregnation 7022 described herein can be adapted for use with any or all of the devices 7010, such as ureteral catheters, described herein. For example, at least one coating and/or impregnation 7022 can be applied to a device 7010 including a distal portion 7018, including an expandable retention portion 7020, that defines a three-dimensional shape 7040 sized and positioned to maintain fluid flow patency between the kidney and the proximal portion 7014 and/or proximal end 7016 of the device 7010, such that, upon deployment at a desired location within the kidney and/or renal pelvis, at least a portion of the fluid flows through the expandable retention portion 7020. In that case, the at least one coating and/or impregnation 7022 may be applied to a portion of the retention portion 7020 that contacts the surface of the three-dimensional shape 7040. Furthermore, as in the previously described embodiments, to match the size and shape of the renal pelvis, the area of a two-dimensional slice 7042 of the three-dimensional shape 7040 defined by the unfolded expandable retention portion 7020 in a plane transverse to the central axis A of the expandable retention portion 7020 can increase toward the distal end 7044 of the expandable retention portion 7020.

In some embodiments, the retention portion 7020 comprises a coiled retention portion extending radially from the renal pelvis to the kidney. The coiled retention portion 7020 can comprise at least a first coil 7046 having a first diameter and at least a second coil 7048 having a second diameter that can be larger than the first diameter to accommodate the size and shape of the renal pelvis. In some embodiments, the at least one coating and/or impregnation 7022 need only be applied to the outer or protective surfaces 1001, 7038 of the coils 7046, 7048, as only such outer or protective surfaces 1001, 7038 are contacted by bodily tissue. The protected surfaces 1000, 7034 of the coils 7046, 7048 may not be coated with the at least one coating and/or impregnation 7022.

In some examples, at least a portion or all of both the protective surface 1001, 7038 and the protected surface 1000, 7034 of the device 7010, such as the coil 7046, 7048, can be coated with at least one coating and/or impregnation 7022. For example, it may be easier for manufacturing or production to apply at least one coating and/or impregnation 7022 to all surfaces of the device 7010 or elongated tube 7012. In some examples, the entire device 7010, e.g., elongated tube 7012, may be coated with a hydrophilic or outermost layer 7024 because the elongated tube 7012 or device 7010 may be in a generally linear (e.g., non-coiled) configuration during insertion through a patient's urinary tract. The sublayers 7030, 7032, which can help improve the long-term performance of the device 7010, need only be applied to portions of the device 7010 or elongated tube 7012 that are likely to be contacted by bodily fluids or tissue (e.g., the outward-facing portion of the tube 7012).
(Multi-layer coating/impregnation for continuous functionality)

In other examples, as shown in FIG. 54, the coated device 7110 includes one or more coatings and/or impregnations 7122 with multiple or different functionalities. The coatings and/or impregnations 7122 can be applied to at least a portion or all of the device 7010. As in the previous examples, the coatings and/or impregnations 7122 can include one or more outermost layers 7124 and one or more innermost layers 7126. The coatings and/or impregnations 7122 can further include multiple sub-layers 7128, 7130, 7132 positioned between the one or more outermost layers 7124 and the one or more innermost layers 7126. The multiple sub-layers 7128, 7130, 7132 can be formed from different materials, each addressing different problems with indwelling catheters and/or providing different functional improvements for the device 7110. The one or more outermost layers 7124 and multiple sublayers 7128, 7130, 7132 may be configured to dissipate sequentially, such that the coatings and/or impregnations provide a first property or functionality over a predetermined period, a second property over a predetermined second period, and a third property over a predetermined third period. For example, the one or more coatings and/or impregnations 7122 may be configured such that dissipation of the outermost layer 7124 and sublayers 7128, 7130, 7132 over time results in a cyclical and/or intermittent effect, including, but not limited to, cycles of antimicrobial and/or antibacterial effect cycled with intermittent cycles of drug delivery. In some cases, drug delivery may be controlled to occur at a predefined time following insertion of the coated device 7110 into the urinary tract, such as limiting drug delivery to a 12-hour release, or a 24-hour release, or a 48-hour release. Similarly, another 12-hour, 24-hour, or 48-hour release of drug may be provided prior to removal of the coated device 7110.

The outermost layer 7124 may be substantially similar in thickness and material properties to the outermost layers described above. For example, the outermost layer 7124 may provide a lubricious outer surface configured to facilitate easier insertion and placement of the device 7110 within the urinary tract when a lubricious coating is not present. The outermost layer 7124 may be configured to remain or may dissipate shortly after implantation within the body, such as within 1 to 10 days of implantation.

The multiple sublayers 7128, 7130, 7132 can be selected so that the sublayers remain for a predetermined period and dissipate over the lifetime or intended duration of the catheter device 7110 within the urinary tract. For example, for a catheter designed to reside within the urinary tract for a period of 10 to 20 days, each of the five sublayers may be configured to dissipate or dissolve in approximately 2 to 4 days. As discussed above, in another example, a layer comprising a therapeutic agent may dissipate within 12, 24, or 48 hours of insertion. Sublayers containing other materials, such as antimicrobial materials and/or pH buffering materials, may dissipate over a longer period of time, such as over a period of 1 to 10 days, or 2 to 8 days, or 3 to 5 days.

In some embodiments, the plurality of sublayers 7128, 7130, 7132 comprises a first sublayer 7128 positioned below the outermost layer 7124. The first sublayer 7128 can be configured to begin to dissipate into the surrounding tissue upon contact with moisture, such as occurs once a portion of the outermost layer 7124 dissipates. As in the previous embodiment, the material of the first sublayer 7128 can be configured to address concerns regarding indwelling catheters and/or improve the functional properties of the coating 7122. For example, the first sublayer 7128 can comprise an antimicrobial layer that provides protection from microbial intrusion into or onto the coating 7122 for a predetermined period of time, such as several days following implantation.

Over the course of several hours and/or days following insertion, the first sublayer 7128 dissipates, exposing the second sublayer 7130 to fluids or moisture. The second sublayer 7130 can comprise one or more coatings and/or impregnations to provide additional properties to improve the function of the device 7110. For example, the second sublayer 7130 can comprise a dose of a therapeutic agent, such as a dose of an antibiotic. The second sublayer 7130 can be configured to either deliver a dose of the therapeutic agent over a short period of time (e.g., a few hours or a day) or for sustained release of the therapeutic agent over a somewhat longer period of time (e.g., 1-10 days, 2-8 days, or 3-5 days). Once the therapeutic agent is released and the second sublayer 7130 dissipates into the surrounding fluids or tissues, the third sublayer 7132 can be exposed to moisture or fluids of the urinary tract. The third sublayer 7132 may be comprised of a material with additional or different functional properties. For example, the third sublayer 7132 may be a pH buffering layer to reduce or eliminate the presence of an encrustation on the device 7110. In other examples, the third sublayer 7132 may be another antimicrobial and/or antibacterial layer. The third sublayer 7132 may be configured to remain in place for hours or days, as with the previous sublayers or layers.

The device 7110 may further include one or more additional sublayers 7026 including materials with different properties to address issues with indwelling catheters and/or improve the functionality of the coating 7122 and the coated device 7110. For example, the coating 7122 may include several therapeutic layers including doses of an antibiotic formulation positioned between sublayers 7026 of antimicrobial material. Thus, the coating 7122 may provide intermittent antibiotic doses separated by periods of time during which no antibiotic is delivered, thereby reducing the risk that antibiotic concentrations will increase above desirable levels.

In some embodiments, the coating 7122 also includes an innermost layer 7126 positioned between the outer surface 7124 of the device 7110 or elongated tube 7112 and the innermost sub-layer 7128. The innermost layer 7126 can be similar in size and material composition to the outermost layer 7124 described herein. For example, the innermost layer 7126 may be comprised of any of the coating materials discussed above, such as a hydrophilic material, that becomes lubricious when exposed to moisture. In some embodiments, the innermost layer 7126 can be exposed just prior to removal of the device 7110. Once exposed to fluid or moisture, the innermost layer 7126 can be configured to become slippery and lubricious, which aids in removal of the device 7110 through the urinary tract. For example, when the innermost layer 7126 becomes lubricious, the elongated tube 7112 of the device 7110 can slide more easily through body tissue, facilitating removal of the device 7110.
(percutaneous urinary catheter)

Examples of ureteral catheters configured to be inserted into the kidney and/or renal pelvis through a percutaneous access site will now be discussed. These ureteral catheters may be used in conjunction with the previously described pump system 800, particularly as shown in FIGS. 21A and 21B. As with the previous examples, ureteral catheters configured for percutaneous insertion may include various retention portions configured to maintain the distal portion and/or distal end of the catheter within the kidney and/or renal pelvis. For example, any of the coils, funnels, expandable cages, balloons, and/or sponges described herein may be used as retention portions to maintain the end of the catheter inserted through a percutaneous access site at a desired location within the urinary tract (e.g., within the renal pelvis, ureter, and/or kidney).

55, an exemplary percutaneous nephrostomy tube or urinary bypass catheter 8010 will be discussed. However, it should be understood that any of the catheters discussed herein may be used in a similar manner as described below. The exemplary urinary bypass catheter 8010 is configured to be deployed within the urinary tract and includes a retention portion 8016 for maintaining the catheter 8010 at a desired position within the urinary tract. The retention portion 8016 of the bypass catheter 8010 may be integrally formed with the distal portion 8014 of the catheter 8010 or may be a separate structure mounted to the distal end 8022 of the extension tube 8018 of the catheter 8010 by conventional fasteners or adhesive. A number of exemplary retention portions 8016 suitable for retaining the distal end 8022 of the extension tube 8018 within the renal pelvis are provided in the previous exemplary embodiments of the ureteral catheter 8010. For example, a retention portion 8016 comprising one or more of a coil, a funnel, a cage, a balloon, and/or a sponge can be adapted for use with a bypass catheter 8010. In some cases, such a retention portion 8016 can be adapted for use with a urinary bypass catheter 8010, for example, by inverting the retention portion 8016 to account for the fact that the urinary bypass catheter 8010 enters the renal pelvis through the kidney rather than through the ureter.

Regardless of the embodiment selected, the retention portion 8016 creates a circumferential or protected surface area that prevents urinary tract tissue from restricting or obstructing the fluid column extending between the nephrocyte unit of the kidney and the lumen of the elongated duct 8018. In some examples, such a retention portion 8016 may comprise an inwardly facing or protected side or surface area 8024 that includes one or more outlet openings, perforations, and/or ports 8026 for receiving fluids, such as urine, produced by the kidney 8102, and an outwardly facing side or protected surface area 8028 that may be free or substantially free of outlet ports 8026. Desirably, the inwardly facing side or protected surface area 8024 and the outwardly facing side or protected surface area 8028 are configured such that when negative pressure is applied through the extension tube 8018, urine is drawn into the lumen of the tube 8018 through the one or more outlet ports 8026, while mucosal tissue, such as tissue of the ureter and/or renal pelvis, is prevented from significantly obstructing the one or more outlet ports 8026. As with the ureteral catheters described above, the size and spacing between the outlet ports 8026 can be varied to achieve different distributions of negative pressure within the renal pelvis and/or kidney, as disclosed herein. In some examples, the one or more outlet ports 8026 each have a diameter of about 0.0005 mm to about 2.0 mm, or about 0.05 mm to 1.5 mm, or about 0.5 mm to about 1.0 mm. In some examples, the exhaust ports 8026 can be non-circular and can have a surface area ^of about 0.0002 ^mm to about 100 mm, or about 0.002 ^{mm to} about 10 mm, or about 0.2 ^mm to about 1.0 ^mm . The exhaust ports 8026 can be spaced equidistantly along the axial length of the retention portion 8016. In other examples, the exhaust ports 8026 closer to the distal end 8022 of the retention portion 8016 may be spaced closer together to increase fluid flow through the more distal exhaust ports 8026 compared to examples in which the ports 8026 are evenly spaced.

The retention portion 8016 may be of any suitable structure for maintaining the distal end 8022 of the elongated tube 8018 at a desired location within the urinary tract. For example, a well-sized retention portion 8016 may have an axial length L11 ranging from about 5 mm to about 100 mm, or from 20 mm to 80 mm, or about 50 mm.

In some embodiments, the retention portion 8016 comprises an expandable structure that transitions from a retracted state when inserting or removing the catheter 8010 from a patient to an expanded or deployed state configured to anchor or retain the retention portion 8016 within the renal pelvis and/or kidney. To sufficiently retain the catheter 8010 at a desired location within the urinary tract, in some embodiments, the retention portion 8016, when deployed, defines a three-dimensional shape 8032 that is sized and positioned to maintain patency of the fluid column flowing between the kidney and the proximal end of the catheter 8010. Additionally, desirably, at least a portion of the fluid produced by the kidney 8102 flows through the retention portion 8016 and the duct 8018, rather than through the ureter. The area of a two-dimensional slice 8034 of the three-dimensional shape 8032 defined by the unfolded expandable retention portion 8016 in a plane transverse to the central axis A of the expandable retention portion 8016 can decrease toward the distal end 8022 of the expandable retention portion 8016, giving the retention portion 8016 a pyramidal or inverted conical shape. In some examples, the maximum cross-sectional area of the three-dimensional shape 8032 defined by the unfolded expandable retention portion 8016 in a plane transverse to the central axis A of the expandable retention portion 8016 is less than or equal to about 500 mm ² , or less than or equal to about 350 mm ² , or between 100 mm ² and 500 mm ² , or between 200 mm ² and 350 mm ² .

In some embodiments, the retention portion 8016 comprises a coiled retention portion comprising a reverse helical coil. The coiled retention portion 8016 can comprise a plurality of helical coils 8036, 8038, 8040 arranged such that the outer periphery or outer region of the helical coils 8036, 8038, 8040 contacts and supports tissue of the kidney and/or renal pelvis and prevents occlusion or obstruction of a protected drain hole, port 8026, or perforation located within the inward-facing side or protected surface area of the helical coils 8036, 8038, 8040.

The coiled retention portion 8016 can include at least a first coil 8036 having a first diameter, at least a second coil 8038 having a second diameter, and at least a third coil 8040 having a third diameter. In order for the retention portion 8016 to fit within the renal pelvis, the diameter of the distal-most or third coil 8040 can be smaller than the diameter of either the first coil 8036 or the second coil 8038. Thus, the diameters of the coils 8036, 8038, 8040 and/or the step distance or height between adjacent coils 8036, 8038, 8040 can vary in a regular or irregular manner. In some examples, the multiple coils 8036, 8038, 8040 can form a tapered or inverted pyramidal shape. In some embodiments, the coiled retention portion 8016 can comprise multiple similarly sized coils, or can include, for example, multiple proximal similarly sized coils and a distal-most coil having a smaller diameter than the other coils of the multiple coils.

The diameters of the coils 8036, 8038, 8040, and the step distance or height between adjacent coils, are selected so that the retention portion 8016 remains within the renal pelvis and/or kidney for a desired period of time. In particular, the coiled retention portion 8016 is desirably large enough to remain within the renal pelvis and not pass either into the ureter or back into the kidney until the catheter 8010 is ready to be removed. For example, the outer diameter of the proximal-most or first coil 8036 can range from about 10 mm to about 30 mm, or about 15 mm to 25 mm, or can be about 20 mm. The second coil 8038 can have a diameter of about 5 mm to 25 mm, or about 10 mm to 20 mm, or can be about 15 mm. The distal-most or third coil 8040 can have a diameter of about 1 mm to 20 mm, or about 5 mm to 15 mm, or can be about 10 mm.
Additional Exemplary Retention Portions of Percutaneous Ureteral Catheters

Another embodiment of a ureteral catheter 8410 configured for percutaneous insertion into a patient's renal pelvis is shown in FIGS. 56A and 56B. As in the previous embodiment, the ureteral catheter 8410 is formed from an elongated tube 8418 having a distal portion 8414 that includes a retention portion 8416. The retention portion 8416 is a coiled retention portion that includes a plurality of coils wrapped around a generally linear or straight section or portion 8430 of the elongated tube 8418.

The coiled retention portion 8416 includes a distal-most coil 8432 formed from an approximately 90-180 degree bend 8434 at the distal end of a straight section or portion 8430 of the retention portion 8416. The retention portion 8416 further includes one or more additional coils, such as a second or middle coil 8436 and a third or proximal-most coil 8438, wrapped around the straight portion 8430 of the tube 8418. The extension tube 8418 further includes a distal end 8440 following the proximal-most coil 8438. The distal end 8440 can be closed or can be open to receive urine from the patient's urinary tract.

As in the previous example, the size and orientation of coils 8432, 8436, 8438 are selected so that retention portion 8416 remains within the renal pelvis and does not pass into the ureter or retract back into the kidney. For example, the largest or most proximal coil 8438 may be approximately 10 mm to 30 mm in diameter, or approximately 15 mm to 25 mm in diameter, or approximately 20 mm in diameter. Coils 8436 and 8438 may have smaller diameters, for example, 5 mm to 25 mm, or approximately 10 mm to 20 mm, or approximately 15 mm. As in the previous example, coiled retention portion 8416 may have a tapered appearance, with coils 8432, 8436, 8438 gradually narrowing, giving retention portion 8416 an inverted pyramidal or conical appearance.

Also, as in the previous embodiment, the retaining portion 8416 further includes an opening or evacuation port 8442 positioned on a radially inward side or protected surface area of the coiled retaining portion 8416. The opening or evacuation port 8442 can also be positioned on the straight portion 8430 of the retaining portion 8416, as the coils 8432, 8436, 8438 extend around the straight portion 8430 and prevent renal pelvis and/or kidney tissue from contacting the straight portion 8430. As in the previous embodiment, the retaining portion 8416 is inserted through the kidney and renal pelvis in a linear orientation over the guidewire. When the guidewire is removed, the retaining portion 8416 adopts the coiled or deployed configuration.

The foregoing examples and embodiments of the present invention have been described with reference to various examples. Modifications and alterations will occur to those skilled in the art upon reading and understanding the foregoing examples. Therefore, the foregoing examples are not to be construed as limiting the present disclosure.

Claims (20)

1. A pump assembly for increasing urine output, said pump assembly comprising:
(a) at least one ureteral catheter configured to be positioned within a patient's ureter, the at least one ureteral catheter comprising: a distal portion comprising a retention portion configured to be positioned within the patient's kidney, renal pelvis, and/or ureter; and a proximal portion comprising a drainage lumen, the retention portion comprising at least one drainage port that allows fluid flow into the drainage lumen;
(b) a pump configured to provide negative pressure to at least one of the renal pelvis or the kidney through the drainage lumen of the at least one ureteral catheter, the pump comprising: at least one fluid port in fluid communication with the drainage lumen of the proximal portion of the at least one ureteral catheter for receiving fluid from the kidney; a housing defining an opening for the at least one fluid port; and a pump chamber at least partially enclosed within the housing fluidly connected to the at least one fluid port, the pump configured to draw the fluid through the drainage lumen of the at least one ureteral catheter and into the pump chamber, thereby exerting the negative pressure on at least a portion of an interior of the kidney and/or the renal pelvis, and at least a portion of the pump including the housing and the pump chamber configured to be positioned within the body outside the patient's urinary tract;
The pump assembly, wherein the retention portion comprises a coil including a first coil and a distal-most coil, the distal-most coil having a diameter less than a diameter of the first coil. The pump assembly of claim 1, wherein the at least one fluid port comprises an inflow port and an outflow port, and the pump assembly further comprises at least one outflow catheter in fluid communication with the outflow port, the at least one outflow catheter configured to conduct the fluid received from the drainage lumen of the at least one ureteral catheter away from the pump. The pump assembly of claim 2, wherein the at least one outflow catheter has a first end connected to the outflow port of the at least one fluid port of the pump and a second end configured to be positioned within the bladder to drain the fluid into the bladder. The pump assembly of claim 2, wherein the at least one outflow catheter has a first end connected to the outflow port of the at least one fluid port of the pump and a second end configured to be positioned outside the patient's urinary tract to drain urine from the kidney. The pump assembly of claim 2, wherein the at least one outflow catheter has a first end connected to the outflow port of the at least one fluid port of the pump and a second end configured to be positioned through at least one percutaneous opening in the patient's kidney to drain urine from the kidney. The pump assembly of claim 4, wherein a portion of the at least one ureteral catheter is positioned within the lumen of the at least one outflow catheter. The pump assembly of claim 6, wherein the portion of the at least one ureteral catheter positioned within the lumen of the at least one outflow catheter is configured to extend through an opening in the bladder wall. The pump assembly of claim 2, further comprising a tubular shunt configured to extend through the patient's bladder wall, and portions of the at least one ureteral catheter and the at least one outflow catheter are positioned within the lumen of the tubular shunt. The pump assembly of claim 2, wherein the at least one urinary catheter includes a first end, the inflow port is configured to receive the first end of the at least one urinary catheter, and the outflow port extends at least partially around the inflow port. The pump assembly of claim 1, wherein the retention portion of the at least one urinary catheter comprises a periphery or protective surface area that, in response to application of negative pressure through the at least one urinary catheter, prevents mucosal tissue from occluding one or more protected drainage holes, ports, or perforations located within the periphery or protective surface area. The pump assembly of claim 10, wherein the one or more protected drain holes, ports, or perforations extend through a radially inward-facing portion of the coil sidewall. The pump assembly of claim 1, wherein the pump is configured to generate sufficient negative pressure within the ureter, the renal pelvis, and/or the kidney to promote urine flow toward the drainage lumen of the at least one ureteral catheter by establishing a pressure gradient. The pump assembly of claim 1, wherein the pump further comprises an induction coil electronically coupled to the battery for providing power to the pump and for recharging the battery. The pump assembly of claim 13, wherein the induction coil is configured to generate electrical power when exposed to an electromagnetic field generated by a remote device positioned outside or within the body. The pump assembly of claim 1, further comprising an external controller positioned outside the body, the external controller being electrically coupled to the pump to provide power to the pump. The pump assembly of claim 1, wherein the pump further comprises a wireless transceiver configured to receive operating instructions from a remote computing device and to provide information about the negative pressure therapy from the pump to the remote computing device. The pump assembly of claim 1, wherein the at least one urinary catheter includes at least one axially deformable section configured to accommodate bodily movements by increasing in length. 18. The pump assembly of claim 17, wherein the axially deformable compartment comprises at least one of an accordion compartment configuration on a sidewall of the at least one urinary catheter, a telescoping compartment of the at least one urinary catheter, or at least one axially extensible compartment. The pump assembly of claim 1, wherein, in the deployed configuration, the diameter of the retention portion is greater than the diameter of the exhaust lumen. The pump assembly of claim 1, wherein the negative pressure applied to the proximal end of the at least one ureteral catheter is between 5 mmHg and 20 mmHg.