WO2025101698A1 - Controllable intravesical bladder outlet occlusion for urinary incontinence - Google Patents

Abstract

The invention relates to a medical device that provides minimally invasive relief from stress and urge urinary incontinence, methods of making the medical device, apparatus and methods for testing the medical device, and treatment for urinary incontinence in a patient. The medical device includes a deformable intravesical urinary control medical device, including an implant device, that includes an outer membrane of a material selected from an impermeable material, a semi-permeable material, a self-sealing material, and combinations or blends thereof, an internal cavity formed of the outer membrane that includes one or more of an internal matrix including a material selected from low-density gas, fluid, gel, polymer or mixture thereof, an internal structure including a plurality of elastic or superelastic spindles, and a magnetic core positioned within the internal cavity; and an extracorporeal magnet that is positioned in the genital/perineal area of a patient body.

Description

CONTROLLABLE INTRAVESICAL BLADDER OUTLET OCCLUSION FOR URINARY INCONTINENCE

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority under 35 U.S.C. § 119(e) to United States Provisional Patent Application Serial No. 63/596,764 filed on November 7, 2023, entitled “CONTROLLABLE INTRAVESICAL BLADDER OUTLET OCCLUSION DEVICE”, which is herein incorporated by reference.

Field of the Invention

[0002] The inventive concept relates to a medical device that provides minimally invasive relief from urinary incontinence, methods of making the medical device, apparatus and methods for testing the medical device, apparatus for placing the device in a patient, and use of the device for treatment of urinary incontinence in a patient.

Background

[0003] Urinary incontinence is a complex and multifaceted condition. Volitional urination occurs when the intravesical pressure of the bladder overcomes the detrusor pressure, leading to the outflow of urine through the bladder outlet and urethra. During normal volitional voiding, urination occurs when a transient increase in the intravesical pressure due to contraction of the detrusor muscle is coupled with the concurrent relaxation of the internal and external urinary sphincters. However, inappropriate elevations in abdominal or detrusor pressure can lead to increased intravesical pressure that can result in urinary leakage. Conversely, neuromuscular compromise of the sphincter can also lead to a decrease in detrusor leak point pressure, resulting in urinary incontinence. Unwanted leakage of urine, known as urinary incontinence, occurs when the bladder neck and voluntary sphincter do not provide sufficient resistance to prevent the outflow of urine during increases in bladder pressure.

[0004] Incontinence is classified into three categories: stress urinary incontinence (SUI), urge urinary incontinence (UUI), and overflow incontinence. SUI is associated with urinary leakage due to increases in intraabdominal pressure in the absence of bladder contraction. SUI occurs when bladder outlet resistance cannot overcome increases in bladder pressure that occur during daily activities such as coughing, laughing, sneezing, or rising from a seated to standing position. This can arise from a variety of etiologies, including neuromuscular weakness of the urinary sphincter secondary to intracranial or spinal cord injuries, and neuropathy associated with systemic conditions such as diabetes. In women, stress urinary incontinence can also arise from weakness of the pelvic floor due to prior childbirth, age, or generalized debility. In men, loss of bladder outlet resistance can occur following common procedures such as transurethral of prostatic tissue (TURP) for benign prostatic hyperplasia or bladder neck incompetence follow radical prostatectomy for prostate cancer.

[0005] UUI occurs when inappropriate bladder contraction leads to an intravesical pressure that exceeds the leak point pressure of the bladder neck and sphincter. This is due to overactivity of the detrusor muscle and can be idiopathic or due to neurologic injury. Many patients experience a mixed stress-urge urinary incontinence phenotype.

[0006] Overflow incontinence occurs when poor bladder emptying due to detrusor muscle hypoactivity or anatomic bladder outlet obstruction leads to elevated baseline bladder volumes with leakage after the bladder volume reaches a certain threshold.

[0007] It is estimated that up to 50% of women suffer from some degree of urinary incontinence. The prevalence of urinary incontinence increases with parity, age, and BMI. Urinary incontinence in men is less common and is often associated with iatrogenic damage to the continence mechanism from urologic instrumentation or radiation administered to treat pelvic or intraabdominal malignancies. The prevalence of urinary incontinence in men older than 65 years, as reported in the literature, is 11 to 34 percent, with a prevalence of daily incontinence estimated to be 2 to 11 percent. Data obtained from 2001 and 2004 using the National Health and Nutrition Examination Survey revealed that 49.6% of all women in the United States suffer from some degree of urinary incontinence. Of these, approximately 50% report pure SUI, 34% report mixed MUI, and 16% report pure UUI.

[0008] Urinary incontinence is associated with decreased quality of life. Medical morbidities include perineal infections and an increased risk of falls due to attempted rapid transit to the bathroom. Additionally, social and sexual function is often significantly impaired in patients with urinary incontinence, with the severity of these impairments correlating with the degree of urinary leakage. The estimated annual economic burden of urinary incontinence in the United States alone is estimated to be over $94 billion and has been rising steeply over the past two decades. Of this, an estimated $12 billion is spent on SUI, for which no medical management is available, with the remaining $82 billion spent on UUI and mixed urinary incontinence. These costs arise from the diagnosis, management, and treatment of incontinence.

[0009] A range of interventions currently exist for urinary incontinence. These interventions are geared towards either decreasing bladder pressure or augmenting bladder outlet resistance. The optimal approach to patients with incontinence depends on the category of incontinence seen clinically and the presence of comorbidities that may preclude certain interventions. First-line treatment for both stress and urge incontinence is behavioral modification geared towards minimizing inappropriate detrusor activity and augmenting sphincter pressure. These approaches include timed voiding and double voiding to reduce peak bladder volumes and pressures, pelvic floor physical therapy, and avoidance of dietary bladder irritants.

[0010] In women for whom pelvic organ prolapse plays a role, placement of a vaginal pessary can often help augment continence by increasing urethral length and closure pressure. Pelvic organ prolapse is commonly found in obese women or women who have undergone childbirth; placement of the intravaginal pessary can help optimize urethral anatomy and augment the pelvic leak point pressure. While improvement in symptoms of prolapse is seen in up to 90% of women using a pessary, only 40% of women demonstrate an improvement in urinary symptoms.

[0011] Patients with UUI due to overactive bladder may also benefit from medications that decrease bladder contractility; these include muscarinic antagonists, such as oxybutynin and beta-adrenergic agonists, such as Mirabegron.

[0012] There are no medications approved for the treatment of SUI.

[0013] The reported success rates of noninvasive interventions vary significantly based on differing published definitions of clinical efficacy. Generally, noninvasive incontinence mitigation strategies achieve acceptable clinical improvements in only 50-60% of women, leaving tens of millions of women with refractory incontinence. For these women, there also exist surgical options for control of urinary incontinence. Cystoscopic injection of urethral bulking agents using a variety of substrates is routinely used in clinical practice. Unfortunately, these interventions are associated with a low cure rate, frequently reported as between 25 and 60% depending on the clinical outcomes used. Placement of urethral slings in either a transobtrurator or retropubic fashion is the second common surgical procedure for treatment of stress incontinence and can be associated with one-year cure rates of 62-98%, with five-year rates nearer 70%. In men, surgical options for the management of urinary incontinence, including in the setting of prior prostatic intervention or radiation, arc more varied due to the increased length of the male urethra. The use of artificial urinary sphincter (AUS) devices has been steadily increasing, especially in patients who have SUI secondary to prostatic removal. However, these invasive procedures require administration of general anesthesia in the operating room, and are associated with a risk of serious complications, including bleeding, infection of the implanted material and urethral erosion. Systemic reviews indicate a pooled cure rate of approximately 79% for the urethral sling and AUS device approaches. Unfortunately, the infection and erosion rate following AUS placement is 8.5%, with mechanical failure rates of 2-13%. The total reoperation rate at two years is 26%. These risks, like those of general anesthesia, increase with age and comorbidities commonly found in the patient population most likely to suffer from urinary incontinence.

[0014] More recently, intravesical devices have been explored as a potential minimally invasive surgical technique (MIST) for incontinence. The Vesair™ system (Solace Therapeutics) is an indwelling intravesical implant that serves as a pressure attenuation device to absorb pressure spikes in the bladder that contribute to UUI and SUI. While this can be effective to minimize the peak intravesical pressure, it does not augment the leak point pressure. A randomized controlled study revealed that 81% of women reported a decrease in pad weight, while 41.6% of women achieved dryness (vs. 45% and 0% in the control group, respectively).

[0015] Transurethral occlusion devices with or without an intravesical component have also been devised to transiently occlude the urethra, with a patient-controlled mechanism to allow for the timed release of urine. These are uncomfortable, poorly tolerated by patients, and provide a nidus for the retrograde transport of bacteria to the bladder lumen, predisposing patients to urinary tract infections. These devices are rarely used in clinical practice and are not included in the American Urological Association guidelines for the management of stress urinary incontinence.

[0016] Given the prevalence, cost, and morbidity associated with urinary incontinence, improved treatment modalities are needed to improve patient care and reduce the societal burden posed by this disorder. Accordingly, the disclosed concept provides a minimally-invasive device that can be deployed into the bladder and removed in a medical (i.e., doctor’s) office setting without the need for anesthesia or the adoption of significant surgical risk. With respect to the disclosed concept described herein, no device currently exists that is designed to occlude/obstruct the bladder neck using buoyancy or magnetic force without an indwelling transurethral tether.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 is a schematic that illustrates a portion of the anatomy of a female body and an intravesical device, in accordance with certain embodiments of the disclosed concept.

[0018] FIGS. 2A, 2B, and 2C are schematics that illustrate cross-sectional views of the components of the intravesical device, in accordance with certain embodiments of the disclosed concept.

[0019] FIGS. 3 A through 3L are schematics that illustrate suitable shapes of the intravesical device, in accordance with certain embodiments of the disclosed concept.

[0020] FIGS. 4A and 4B are schematics that illustrate suitable shapes of extracorporeal magnets, in accordance with certain embodiments of the disclosed concept.

[0021] FIGS. 5 A through 5G2 are schematics that illustrate cross-sectional views of the intravesical device and an endoscopic device for deployment, introduction and retrieval, in accordance with certain embodiments of the disclosed concept.

[0022] FIG. 6 is a schematic that illustrates an in vitro testing apparatus for testing and measuring the intravesical device, in accordance with certain embodiments of the invention. [0023] FIG. 7 is a plot that illustrates testing data for the intravesical device, in accordance with certain embodiments of the invention.

[0024] FIGS. 8 A and 8B are images that illustrate insertion of the intravesical device in a bladder and the upward and downward positioning of the device with or without the extracorporeal magnet, respectively, in accordance with certain embodiments of the invention.

SUMMARY OF THE INVENTION

[0025] In one aspect, the disclosed concept provides a deformable intravesical urinary control medical device including an implant device, including an outer membrane, comprising a material selected from an impermeable material, a semi-permeable material, a self- sealing material, and combinations or blends thereof; an internal cavity formed of the outer membrane, including one or more of an internal matrix, including a material selected from low-density gas, fluid, gel, polymer or mixture thereof; an internal structure, comprising a plurality of spindles comprised of an elastic or superelastic material; a magnetic core positioned within the internal cavity; and an extracorporeal magnet, wherein the extracorporeal magnet is positioned in the genital/perineal area of a patient body and provides a magnetic field for caudal attraction of the device.

[0026] The outer membrane can include a material selected from the group consisting of silicone, latex, polyurethane, expanded polytetrafluoroethylene, and mixtures or combinations thereof.

[0027] The internal structure can include a plurality of interlocking nitinol spindles forming a structural scaffold. The internal matrix can include a porous hydrophilic matrix capable of hydration for mass calibration. The internal matrix can include a calibration material to allow for calibration of density and balance between the gravitational and buoyant force. The magnetic core can include one or more neodymium permanent magnets arranged in a cylindrical manner. [0028] The device can further include a locking mechanism to prevent accidental discharge during bladder contraction/micturition. The device can interconvert between an outer diameter of 5-10 mm and 15-25 mm. The device can occupy a volume of 10 to 30 ccs. The device can have a density from 0.70 to 1.00 g/cc.

[0029] The device can further include a loop or tag that protrudes from the outer membrane to facilitate cystoscopic removal.

[0030] The extracorporeal magnet can attract the implant device thereby providing occlusion of urinary outflow from the bladder for relief or urinary incontinence. The extracorporeal magnet can include a planar neodymium magnet. The extracorporeal magnet can include an electromagnetic plate. The extracorporeal magnet can be embedded within a flexible material. The flexible material can include rubber to facilitate patient comfort. The extracorporeal magnet can be attached to a patient’s undergarment.

[0031] In another aspect, the disclosed concept provides a method of employing the foregoing intravesical urinary control device. The method includes positioning the implant device in a hollow cylinder comprising a cavity, wherein the implant device deforms into an elongated shape in the cavity; passing the implant device through the cavity, wherein the implant device adopts a new shape/size/density upon exiting the cavity; positioning the implant device into the bladder of a patient body; and positioning the extracorporeal magnet in a genital/perineal area of a patient body. [0032] The hollow cylinder can include a piston to extrude the device from the cylinder. In addition, a guide needle can be used to alter the physical characteristics of the device including one or more of size, shape and density.

[0033] In another aspect, the disclosed concept provides a method of making an intravesical urinary control medical device. The method includes fabricating an implant device, including preparing an outer membrane, including obtaining or manufacturing a pre- shaped metal or polymer mold; and coating the mold with a flexible material to produce the outer membrane, wherein the outer membrane forms an internal cavity; positioning in the internal cavity, one or more of: an internal matrix, comprising a material selected from low-density gas, fluid, gel, polymer or mixture thereof; an internal structure, comprising a plurality of spindles comprised of an elastic or superelastic material; and positioning in the internal cavity a magnetic core; and providing an extracorporeal magnet, wherein the extracorporeal magnet is positioned in the genital/perineal area of a patient body and provides a magnetic field for caudal attraction of the device.

[0034] The outer membrane can have a shape selected from sphere, oblong sphere, cone, bicone, and teardrop. The outer membrane can include silicone.

[0035] In yet another aspect, the disclosed concept includes a method of treating a patient for stress urinary or urge urinary incontinence. The method includes preparing a scaffold, including a plurality of superelastic or elastic spindles, including a biocompatible ferromagnetic material; a porous internal matrix, including at least one material selected from the group consisting of low- density gas, fluid, gel, and polymer; a magnetic core; and an outer impermeable membrane that encompasses the spindles, internal matrix and magnetic core; interconverting the scaffold into a deploying conformation to form an occlusive scaffold; positioning by transurethral insertion the occlusive scaffold into a bladder lumen of the patient; and positioning the occlusive scaffold in an open configuration, wherein the diameter of the device is sufficient to occlude the bladder outlet of the patient to prevent stress urinary or urge urinary incontinence.

[0036] This method can further include pairing the scaffold with an extracorporeal magnet positioned in the genital/perineal area of the patient body and providing a magnetic field for caudal attraction of the device. The extracorporeal magnet can be positioned within an undergarment worn by the patient. [0037] In still another aspect, the disclosed concept includes a testing device to assess multiple shapes, sizes, and magnetic contents of an intravesical urinary control medical implant device ex vivo, including a vertical stand; a horizontal ring moveably coupled to the vertical stand; and 3-D printed models of human bladder comprising firm, malleable, or flexible plastic or rubber, wherein the horizontal ring is structured to contain the 3-D printed models of human bladder, to optimize the medical implant device size/shape to an individual’s bladder anatomy at varying stages of filling. In certain embodiments, the height of the ring on the vertical stand is variable to allow for calibration of magnetic fields to achieve desired or selected buoyancy. In certain embodiments, the testing device further includes one or more of a newton meter and an optical location tracker, and/or a modelled bladder outlet/urethra through which fluid placed in the model can efflux, allowing for the testing of the device under physiologic conditions. The human bladder may be in both an open and closed system to allow for the controlled generation of hydrostatic pressure to mimic bladder contractions to test for urinary leakage over a variety of pressures.

[0038] The height of the ring on the vertical stand can be variable to allow for calibration of magnetic fields to achieve desired or selected buoyancy.

[0039] The testing device can further include one or more of a newton meter and an optical location tracker.

[0040] The testing device can further include a modelled bladder outlet/urethra through which fluid placed in the model can efflux, allowing for the testing of the device under physiologic conditions.

[0041] The testing device can further include a scale beneath the device to assess the flow of urine through a modelled or explanted bladder can be tested.

[0042] The human or mammalian bladder can be in both an open and closed system to allow for the controlled generation of hydrostatic pressure to mimic bladder contractions to test for urinary leakage over a variety of pressures.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] While the general disclosed concepts are susceptible of embodiment in many forms, there are shown in the drawings, and will be described herein in detail, specific embodiments thereof with the understanding that the present disclosure is to be considered an exemplification of the principles of the general inventive concepts. Accordingly, the general inventive concepts are not intended to be limited to the specific embodiments illustrated herein. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0044] The articles “a” and “an” are used herein to refer to one or more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “a spindle” means one spindle or more than one spindle. “About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass significant variations of ±50%, from the specified value given the anatomic and physiologic range of the adult urinary system, as such variations are appropriate to perform the disclosed methods.

[0045] As used herein the term “patient” or “user” means a member of the animal kingdom, including, but not limited to, a human. As used herein, the term “therapeutically effective” refers to any reduction in unwanted symptoms, i.e., urinary leakage, that the patient may experience. As will be understood by one skilled in the art, a therapeutically effective response will be determined by subjective and objective clinical parameters.

[0046] The disclosed device and methods described herein represent a treatment for stress and urge urinary incontinence including a device implanted within the bladder that uses magnetic forces with an external magnetic field originating near the patient’s perineum. Further, the inventive concept herein describes the delivery, testing, and manufacturing apparatus necessary to develop and deploy the device. This device is a controllable intravesical bladder outlet occlusion (CIBOO) device. The CIBOO is designed and fabricated to augment the leak point pressure of the bladder, providing protection against both stress and urge urinary incontinence. Further, the CIBOO is designed and fabricated to facilitate transurethral insertion using standard endoscopic tools and a dedicated endoscopic introducer. The CIBOO is designed to be introduced in a narrow conformation via a transurethral approach and "locked" into a wide conformation once placed within bladder lumen to transiently occlude the bladder neck. The CIBOO interconverts between a narrow, elongated conformation amenable to transurethral insertion and a modified spherical conformation that can sit at the bladder neck with a diameter sufficient to occlude the bladder outlet to prevent incontinence. Application of a caudal occlusive force requires that the downward force and gravitational force, when combined, exceed the buoyant force of the object. In the disclosed concept herein, that downward force sufficient to augment the leak point pressure is provided by a permanent magnet embedded within the intravesical device that interacts with the magnetic field of an extracorporeal magnet located near the patient’s gcnitals/pcrincum. In the absence of the external magnetic field, the CIBOO device is calibrated such that it will be less dense than the surrounding urine, and thus, floats to the top of the bladder to allow emptying.

[0047] Accordingly, the disclosed concept provides a magnetic, untethered, moderately deformable intravesical device that, when paired with an external magnetized or electromagnetic material located at the patient’s genitals/perineum, reversibly occludes the bladder neck to prevent the outflow of urine at times when urination is not desired.

[0048] FIG. 1 illustrates a bladder occlusion device in accordance with certain embodiments of the invention. FIG. 1 shows the anatomy of a female body 10 that includes a bladder (3), bladder neck (3a), urethra (3b), uterus (4), vagina (5), and rectum (6). FIG. 1 also shows an untethered, deformable intravesical urinary control medical implant device (1) and an extracorporeal magnet (2). The device (1) is positioned within the bladder (3) and the magnet (2) is positioned at the patient’s genitals/perineum of a female body 10. In certain embodiments, the extracorporeal magnet (2) is positioned within an undergarment (2a) worn on the patient’s body 10. In the absence of the external magnetic field, i.e., magnet (2), the CIBOO device is calibrated such that it will be less dense than the surrounding urine, and thus, floats to the top of the bladder to allow emptying.

[0049] FIGS. 2A and 2B illustrate the device (1) in accordance with certain embodiments of the invention. FIG.2A shows a cross-sectional view of the device (1) that includes an outer membrane (7), an internal matrix (8) that includes one or more of a low-density gas, fluid, gel or polymer, and a magnetic core (9). FIG. 2B shows a cross-section view of the device (1) that includes the outer membrane (7) and the magnetic core (9), as well as an internal structure (10) comprising an elastic or a superelastic web structure. In certain embodiments, the device (1) shown in FIG. 2B also includes the internal matrix (8) that includes one or more of the low- density gas, fluid, gel or polymer (FIG. 2C), whereas in other embodiments, the device (1) excludes the internal matrix (8) that includes one or more of the low-density gas, fluid, gel or polymer (FIG. 2B). In addition, the device (1) includes a tag or loop (11) on the surface of the device (FIGS. 2A, 2B and 2C) to facilitate cystoscopic extraction using existing cystoscopic instrumentation, such as cystoscopic graspers. [0050] The outer membrane (7) is composed of an impermeable, selectively permeable, semi- pcrmcablc, and/or self-scaling material to facilitate bladder neck (3a) occlusion. In certain embodiments, the outer membrane (7) is fixed to the deformable internal structure (10). In other embodiments, the outer membrane (7) itself imparts elements of form and deformability to the device. The outer membrane (7) prevents infiltration of the device with urine or air to ensure that the buoyancy of the device is not significantly altered following implantation, similar in concept to a balloon. In certain embodiments, the outer membrane (7) is selected from silicone, latex, polyurethane, or expanded polytetrafluoroethylene, and the internal matrix (8) is selected from a low-density gas, fluid, gel, and polymer. In certain embodiments, the outer membrane (7) has a secondary material embedded within a primary material to augment desirable biomechanical properties of the membrane. In certain embodiments, the outer membrane (7) is self-sealing to allow for instillation or removal of air, fluid, or gel into the device via endoscopic techniques to facilitate deployment.

[0051] Accordingly, the untethered, deformable intravesical urinary control medical implant device (1) contains permanently magnetized or ferromagnetic material in the magnetic core (9) that interacts via magnetic force from the extracorporeal magnet (2) to prevent or attenuate the flow of urine through the bladder neck (3a), thus limiting urinary leakage. The composition and structure of the device (1) includes the magnetic core (9), the deformable internal structure (10) comprising elastic or superelastic material, the internal matrix (8) to prevent significant volumetric compression that includes one or more of low-density gas, fluid, gel, or polymer, and the impermeable or semi-permeable outer membrane (7) that prevents the flow of urine into the device or through the bladder neck (3 a).

[0052] In one aspect of the disclosed concept, the magnetic core (9) interacts with an external magnetic field of the extracorporeal magnet (2) positioned near the patient’s genitals/perineum (as shown in FIG. 1), e.g., within or integrated with an undergarment (2a) worn on the patient’s body. In certain embodiments, the extracorporeal magnet (2) is selected from a narrow rigid magnet or a rubber- infused flexible magnet. In certain embodiments, the magnetic core (9) and the magnet (2) are ferromagnetic or permanently magnetic, and include the use of rare earth magnets such as neodymium. In certain embodiments, the shape and positioning of the magnetic source within the intravesical device, as shown in FIGS. 2A, 2B and 2C, is a central cylindrical magnetic core (9) embedded in the impermeable or semi-permeable outer membrane (7) and the internal matrix (8) and/or the superelastic internal structure (10). In other embodiments, the magnetic material (9) is positioned in a multifocal manner in a central or peripheral aspect of the device (1). The extracorporeal magnet (2) generates a magnetic field to facilitate migration of the intravesical device (1).

[0053] FIGS. 3A-3L illustrate various shapes for device (1) as well as varying lengths of the magnetic core (9), in accordance with certain embodiments of the disclosed concept.

[0054] FIGS. 4A and 4B illustrate the extracorporeal magnet (2), in accordance with certain embodiments of the invention. The length and width of the magnet (2) can vary. As shown in FIG. 4A, the magnet (2) has a corresponding length of 1.5 inches and a width of 1 inch; additionally, the thickness is 0.18 inch and the maximum pull is 23.25 pounds. As shown in FIG. 4B, the magnet (2) has a corresponding length of 1.5 inches and a width of 1.5 inches; additionally, the thickness is 0.125 inch and the maximum pull is 96 pounds.

[0055] In certain embodiments, the extracorporeal magnet is worn within the patients’ undergarments during regular activity. Depending on the patient’s body habitus and projected distance of which force must be applied, the magnet is selected from a narrow rigid magnet or a rubber-infused flexible magnet to provide downward force on the intravesical device. In one embodiment, this magnet is composed of a permanent or induced ferromagnetic material, such as an iron-based magnet or neodymium rare earth magnet. In another embodiment, an electromagnet is used for field generation.

[0056] To ensure that the occlusive force is sufficient to augment the bladder leak point pressure to physiologically meaningful levels, the CIBOO intravesical device component of the disclosed concept contains one or more permanent magnets, e.g., the magnetic material. In one embodiment, these magnets adopt a linear cylindrical conformation along the central axis of the device (as shown in FIGS 1, 2A-2C and 3). In other embodiments, the magnet is in the form of magnetic spindles with or without the magnetic core.

[0057] The need for device deformation for deployment and bladder neck occlusion necessitate the elastic or superelastic internal structure during insertion and while deployed. The structure has various shapes that include but are not limited to a sphere, oblong sphere, cone, bicone, and teardrop (e.g., as shown in FIGS. 3A-3L). The moderate degree of deformability facilitates interconversion between forms but resists significant deformation during regular use that would lead to expulsion of the device. In another embodiment, the shape may be custom-printed based on clinical imaging obtained for specific patient or patients. In certain embodiments, as shown in FIGS. 2 A, 2B and 2C, the structures arc achieved by integration of the magnetic core (9) of the device into a porous internal matrix (8) surrounded by an outer membrane (7). In certain embodiments, the porous internal matrix (8) is comprised of a hydrophilic polymer to allow for the instillation of aqueous solution or gas for mass, and therefore buoyant force, calibration. In certain other embodiments, as shown in FIG. 2C, the structure of the porous internal matrix (8) is augmented by the internal structure (10) that, in certain embodiments, is comprised of elastic nitinol spindles embedded within the internal matrix (8) and/or outer membrane (7), to allow the device to interconvert between shapes when external forces are applied. In yet other embodiments, as shown in FIG. 2B, the porous internal matrix (8) is omitted, and the internal structure (10), e.g., a nitinol structure, supports a hollow outer membrane (7) that can be instilled with gas, fluid, gel, or other polymers for mass calibration.

[0058] In yet another aspect, the inventive concept includes a method of making an intravesical urinary control medical implant device, including obtaining a pre-shaped metal or polymer mold; coating the mold with a flexible silicon elastomer to produce a coated mold; curing the coated mold to produce a cured mold; trimming a base of the cured mold to produce a trimmed bottom; and embedding magnets and/or secondary structural materials into the molded material to augment the biomechanical properties of the material and/or function of the device in bladder neck occlusion. Other embodiments include pre-forming metallic or nitinol wires to be embedded without the molded material. The concept also includes placement of additional materials within the outer membrane, including the magnetic material, filling material for buoyancy calibration, and structural porous/gelatinous material as described elsewhere.

[0059] Suitable materials for construction of the deformable polymeric outer membrane (7) include permeable, semi-permeable, impermeable, and self- sealing materials that include, but are not limited to, silicone, latex, polyurethane, or expanded polytetrafluoroethylene (ePTFE). In certain embodiments of the device, the outer membrane (7) has elastic or superelastic spindles, including but not limited to nitinol and permanent magnetic materials, embedded within its material to augment the structure of the membrane. In other embodiments of the device, the above characteristics are combined with a tag or loop (11) on the surface of the device to facilitate cystoscopic extraction using existing cystoscopic instrumentation, such as cystoscopic graspers, as shown in FIGS. 2A, 2B and 2C. [0060] In another aspect of the disclosed concept, the device (1) is deformable to interconvert between a narrow, elongated structure and a wider structure that can deform in situ to occlude the neck (3a) of the bladder (3). To achieve this conversion with minimal volumetric compression once implanted, the device (1) contains the deformable internal structure including the internal matrix (8) that comprises a porous synthetic material selected from the group consisting of low- density gas, fluid, gel, and/or polymer. In certain embodiments, the internal matrix (8) is hydrophilic such that water or an aqueous compound is used to hydrate the material to calibrate the mass and buoyancy of the device (1) when submerged in the bladder (3). In certain embodiments, the implanted device (1) contains a scaffold (10) comprised of an elastic or superelastic material. Optionally, the scaffold (10) includes a plurality of spindles and/or a continuous sheet with or without concurrent use of a porous internal matrix (8). The spindles and/or continuous sheet include, but are not limited to, an outer structure attached to a stabilizing inner mesh to which the magnetic components are fixed. In certain embodiments, the scaffold (10) includes the use of nitinol and/or formed silicone to achieve deformability. In certain embodiments utilizing a nitinol structure, structural flexibility for deployment may include a locking mechanism to reduce the possibility for accidental discharge during bladder contraction/micturition .

[0061] In another aspect, the inventive urinary control device must be implantable within the lumen of the human bladder. This includes minimally-invasive implantation into the bladder; most notably the native urethra, but also via percutaneous placement through existing suprapubic tube tracts/vesicostomies or suprapubic tracts/vesicostomies created explicitly for device implantation. Implantation through the urethra, suprapubic tract, or vesicostomy suggests the need for interconversion between an elongated state no more than about 10 mm in its widest dimension and a deployed conformation capable of occluding urine flow through the bladder neck without unintended extrusion through these efflux points. As such, the volume occupied by the device upon deployment would be 10-30 cc in most embodiments. The mass of the device will be calibrated to ensure buoyant forces can overcome gravitational forces upon withdrawn of the magnetic field achieved using the extracorporeal magnet (2).

[0062] According to certain embodiments, in its elongated form, the CIBOO has a total diameter about 3 and 10 mm to facilitate placement through the urethra or suprapubic cystoscopy, as these native openings are able to accommodate routinely used clinical indwelling and temporary devices with diameters of up to 10 mm and lengths in excess of 10 cm. Modern indwelling urinary catheters arc kept in position with intravesical balloons with volumes of 10 to 50 ccs without a significant rate of expulsion through the urethra or suprapubic cystotomy. Thus, in certain embodiments, the final intravesical device volume will be about 10-50 ccs, with some variability to account for the anatomic differences in bladder neck shape between patients. [0063] The delivery and retrieval systems required to effectively deploy and remove the CIBOO device are compatible with commercially available urologic instrumentation to facilitate placement in the office or operating room setting and elective or urgent removal. The delivery system employed depends, in part, on the device characteristics, which may vary according to patient-specific anatomic of physiologic parameters. In certain embodiments, the delivery system is a rigid cylinder, open at the distal-most end, containing the CIBOO intravesical device that is deformed by inward pressure from the cylinder walls with a radius of about 5-10 mm, thereby facilitating transurethral or suprapubic device placement. This can be performed blind or under visual guidance with an accompanying multichannel introducer. Once the CIBOO device is advanced into the bladder, a piston operated from an extracorporeal position ejects the device from the introducer into the bladder, allowing it to adopt its final shape as dictated by its internal construction. The device is then retrieved using standard cystoscopic instrumentation, including a camera and graspers.

[0064] In another embodiment, the device is deformed by anchoring of its intrinsic structure to a disposable or reusable deployment instrument using a filament, wire, or snare. The device is then deployed into the bladder after insertion through the urethra or a suprapubic cystotomy by cleavage of the anchoring wire/filament or opening of the snare.

[0065] In yet another embodiment, the device is inserted into the bladder via one of the delivery mechanisms described above, or through the working channel of a commercially available cystoscopy. The device volume is then augmented to its final target via endoscopic injection of a gas, fluid, gel, or polymer through the working channel of a commercially available cystoscope. [0066] FIGS. 5A-5G2 illustrate the collapse, deployment and retrieval of the CIBOO in accordance with certain embodiments of the invention. As shown in FIG. 5A, the device (1) is in a collapsed or elongated form and positioned inside of a tubular cavity (20). In FIG. 5B, the device (1) is partially collapsed within the tubular cavity (20) and partially expanded (e.g., balloon-like) outside the tubular cavity (20). In addition, a push rod (21) is snugly positioned within the tubular cavity (20). As shown, the arrow indicates that exerting force on the push rod (21) advances the device (1) through the push rod (21) for deployment and delivery into the bladder (3). FIG. 5C illustrates the device (1) fully pushed through the tubular cavity (20), e.g., deployed, for delivery to and implantation in the bladder (3). Whereas FIGS. 5D, 5E, 5F, 5G1 and 5G2 illustrate retrieval of the device (1) from the bladder (3). FIG. 5D illustrates a wire hook (22) positioned or located in the tubular cavity (20) and advanced therethrough (as indicated by the arrow) such that the wire hook (22) engages the loop (11) positioned on the device (1). FIG. 5E shows the wire hook (22) engaged with the loop (11) to pull the device (1) through the tubular cavity (20) for retrieval from the bladder (as indicated by the arrow). The device (1) is partially collapsed within the tubular cavity (20) and partially expanded (e.g., balloon-like) outside the tubular cavity (20). FIG. 5F shows the wire hook (22) engaged with the loop (11) and the device (1) is fully collapsed and retracted within the tubular cavity (20). FIGS. 5G1 and 5G2 show an additional mechanism by which the intravesical device (1) is introduced into the bladder (3). In this embodiment, as shown in FIG. 5G1, the device (1) is introduced into the bladder while clasped by an endoscopic grasper/snare (24) placed through the tubular cavity (20), e.g., an endoscopic instrument with or without camera guidance. A needle (25) is placed through the tubular cavity (20). In certain embodiments, the needle (25) injects a substance, including but not limited to a gas, liquid, or gel into the device (1), e.g., through the self-sealing outer membrane (7), to induce a change in shape, size, mass, or density to facilitate function. As shown in FIG. 5G2, the device (1) is then released from the grasper/snare (24) into the lumen of the bladder to complete the deployment process.

[0067] As shown in FIGS. 5A-5C, upon deployment for entry into the bladder, the device (1) is mildly deformable to allow for conformation to the contour of the neck of the bladder neck. The neck of the bladder is a dynamic system that varies in shape between patients. Thus, it is advantageous for the CIBOO to include a variety of design options (e.g., as shown in FIGS. 3A- 3L) that are selected based on patient characteristics and response to therapy. To function safely, the buoyancy force of the CIBOO intravesical device in liquid should exceed the gravitational force exerted on the mass of the device (1). This is accomplished by ensuring that the volume of the device (1), and thus density, remains relatively consistent and lower than the specific gravity of the surrounding urine. The physiologic specific gravity of urine ranges from 1.005 kg/m3 (1.03 gm/cc) to 1.050 kg/m3 in patients with severe dehydration. Thus, in certain embodiments, the CIBOO device has a density of about 0.70- 1 .00 g/cc to minimize the strength of the magnetic field necessary to keep the device in position while ensuring it floats upon withdrawal of the field to allow the efflux of urine through the bladder outlet.

[0068] In another aspect, the inventive concept includes a testing device to assess multiple shapes, sizes, and magnetic contents of an intravesical urinary control medical implant device ex vivo, including a vertical stand; a horizontal ring moveably coupled to the vertical stand; and three-dimensional (3-D)printed models of human bladder comprising firm, malleable, or flexible plastic or rubber, wherein the horizontal ring is structured to contain the 3-D printed models of human bladder, to optimize the medical implant device size/shape to an individual’s bladder anatomy at varying stages of filling. In certain embodiments, the height of the ring on the vertical stand is variable to allow for calibration of magnetic fields to achieve desired or selected buoyancy. In certain embodiments, the testing device further includes one or more of a newton meter and an optical location tracker, and/or a modelled bladder outlet/urethra through which fluid placed in the model can efflux, allowing for the testing of the device under physiologic conditions. The human bladder may be in both an open and closed system to allow for the controlled generation of hydrostatic pressure to mimic bladder contractions to test for urinary leakage over a variety of pressures.

[0069] In still another aspect, the inventive concept includes method of treating a patient for stress urinary or urge urinary incontinence, including preparing a scaffold in an introducer conformation, including a plurality of superelastic or elastic spindles comprising a biocompatible ferromagnetic material; a porous internal matrix containing at least one material selected from the group consisting of low-density gas, fluid, gel, and polymer; a magnetic core; and an outer impermeable membrane; interconverting the introducer scaffold into a deploying conformation to form an occlusive scaffold; positioning by transurethral insertion the occlusive scaffold into a bladder lumen of the patient; and locking the occlusive scaffold in an open configuration, wherein the diameter of the device is sufficient to occlude the bladder outlet of the patient to prevent stress urinary or urge urinary incontinence. In certain embodiments, the method further includes pairing the scaffold with an external magnet that is positioned within undergarments worn by the patient.

[0070] In still another aspect, the inventive concept includes a device that introduces the intravesical device into the bladder through the patients’ urethra, suprapubic tube site, or vesicostomy site. This device comprises a hollow cylinder with a piston-deployment apparatus whereby the treating healthcare provider can extrude the device from its deforming cylinder into the bladder from an extracorporeal position. This device could, but does not necessarily need to, include a separate working channel for endoscopic cameras or supportive instrumentation. [0071] In one embodiment, the CIBOO is a skeleton structured in an elongated cylindrical conformation constrained by a cylindrical purpose-built “introducer” that limits the diameter to about 3-10 mm. The structure of this embodiment includes a plurality of nitinol spindles that are parallel with a cylindrical neodymium magnet oriented along the central axis of the device that also serves as an anchor point for the spindles and the locking mechanism for the device. The plurality of spindles are interlocked and anchored to this magnetic core via two toroid end caps around which each spindle are looped and freely mobile to limit the amount of shear force experienced during conformational transitions. Once deployed, the nitinol spindles bend to adopt the shape of an oblong sphere. Attached to the base of the CIBOO is a string that is pulled to deploy the device and engage a locking mechanism that consists of a nondegradable tether that engages a clasp-like locking mechanism. The redundant tether is then severed for deployment. The clasp can then be grasped using standard urologic instrumentation to release the tether and allow the nitinol spindles to elongate at the time of removal.

[0072] Fabrication

[0073] Fabrication of the various embodiments of the CIBOO includes one or more of the following methods.

[0074] In certain embodiments, the CIBOO that contains structural augmentation with nitinol mesh, structures including a plurality of individual nitinol spindles that are independent, interlocking, and/or embedded within other structural elements are manufactured using two primary methods: (i) laser cutting of nitinol tube and (ii) micro laser welding of nitinol wires. Diverse shapes of metal mandrels are produced using conventional machining processes such as turning, milling, and grinding. To attain the intended final shape, the mesh structure is placed on the mandrel using mechanical stretch during the shape-setting phase. Subsequently, the nitinol structure undergoes thermal treatment, e.g., at a temperature of about 500°C for about 300 minutes. Following the thermal treatment, a quenching process, e.g., in a 20°C water chamber, is employed to achieve the desired superelastic properties of the nitinol. [0075] In certain other embodiments, the CIBOO is fabricated using a mold preparation method. Prc-shapcd metal or polymer molds arc selected. The molds arc then coated with a flexible silicone elastomer such as, but not limited to, a product that is commercially available under the trade name Smooth-On^1M. In certain embodiments, the pre-shaped mold has a shape selected from sphere, oblong sphere, cone, bicone, and teardrop and furthermore, the elastomer optionally includes Smooth-On™. The coated molds undergo a curing process. In certain embodiments, the curing process includes placing samples in a vacuum desiccator at room temperature for one hour to remove bubbles within the silicone layers. After curing, the molds are trimmed at the base of the device to remove excess material. The trimmed bottom of the device is designated for inserting and coating the mold with a flexible silicon elastomer to produce a coated mold.

[0076] In certain other embodiments, molds are three-dimensional (3-D) printed based on medical imaging of patients’ urologic tracts, including their bladder. In yet another embodiment, molds are crafted by hand. Once the device has been cast into the molds using the aforementioned materials, the disclosed concept includes curing the coated mold to produce a cured mold; trimming a base of the cured mold to produce a trimmed bottom; and embedding magnets and/or secondary structural materials into the molded material to augment the biomechanical properties of the material and/or function of the device in bladder neck occlusion. Other embodiments include pre-forming metallic or nitinol wires to be embedded without the molded material. The concept also includes placement of additional materials within the outer membrane, including the magnetic material, filling material for buoyancy calibration, and structural porous/gelatinous material as described elsewhere.

[0077] The disclosed concept’s simple and safe design allows for its placement and removal in empirically determined intervals of about 3-12 months with no need for more frequent follow up if the device is well tolerated by the user. This design also eliminates the need for any permanent transurethral device that could lead to ongoing seeding of the bladder reservoir with bacteria, which is a proven limitation of previously-developed devices. There are products currently on the market with polymers designed to suppress encrustation within the urinary systems. For example, optima inlay urethral stents are approved for indwelling use for up to six months. A trial that evaluated the clinical utility of the VesAir™ balloon allowed for the retention of the balloon for 12 months prior to exchange or removal. As noted above, the density of the deployed configuration of the CIBOO device is calibrated such that, in the absence of an external magnetic field, the CIBOO device will be less dense than the surrounding urine, and thus, will float to the top of the bladder to allow emptying. If this feature malfunctioned and the device remained seated, simple straight catheterization would be sufficient to dislodge the device upward to allow for the outflow of urine.

Device Testing and Optimization

[0078] The disclosed concept includes mechanisms by which prototypes are tested for iterative design improvement to achieve optimal therapeutic efficacy. The disclosed concept includes a provision for the testing of intravesical devices and external magnets of different shapes, sizes, and magnetic contents of an intravesical urinary control medical implant device in vitro and ex vivo.

[0079] FIG. 6 illustrates an apparatus for design testing in accordance with the disclosed concept. The apparatus including a vertical stand (23) and a horizontal portion (24) that is moveably coupled to the vertical stand with integrated distance control and optical/mechanical position sensing. In this horizontal portion (24), in some embodiments, rests a beaker containing an aqueous solution simulating the biomechanical properties of urine in which device prototypes can be placed. In other embodiments, explanted urologic tissue or 3-D printed models of human bladder comprising firm, malleable, or flexible plastic or rubber may be affixed to the ring for leak testing. In some embodiments, a fluid pump may be used to simulate filling of the explanted or artificial bladder.

[0080] Further, in certain embodiments, the testing device also includes a modelled bladder outlet/urethra through which fluid placed in the model can efflux, allowing for the testing of the intravesical device under physiologic conditions. In further embodiments, the bladder is in both an open and closed system to allow for the controlled generation of hydrostatic pressure to mimic bladder contractions to test for urinary leakage over a variety of pressures. For example, this pressure is applied pneumatically or mechanically. Additional computation apparatus to measure force is also included in this embodiment. The use of tissue from human or nonhuman animals in the above apparatus to mimic the tissue characteristics of humans is also included. [0081] In some embodiments, a magnet (25) corresponding to the size and shape of the proposed extracorporeal magnet (2) will be placed beneath the apparatus, and a newton meter affixed to the buoyant device, for measurement of attractive forces, gravitational forces, and buoyant forces. EXAMPLES

Example 1

[0082] To provide data to inform construction of the in vitro and ex vivo testing protocols to assess device feasibility and function, a series of CT scans from females of varying body habitus and ages were reviewed. Linear distances between the bladder neck and external labia, the site at which the inventive devices’ external magnet rests when continence is desired, were measured. The majority of measured distances fell within 6-8 cm, with the longest measured distance being 13 cm. From these, two pliable 3-D printed models of partially distended female bladders were generated to inform protype design as it relates to device shape and degree of deformation needed to occlude flow.

Example 2

[0083] A series of device prototypes were manufactured. The predominant material used for prototyping was silicone. The shapes used for mold casting included both 3-D printed bladder necks generated from CT scans as described above to 3-D printed spherical and oblong models corresponding to the conceptually desirable 10-20 cc implanted volume. Prototypes were assembled from either two fused molded components or a single continuous molded component. To represent another embodiment of the device, pre-formed cylindrical nitinol wire tubes were affixed to the outer membrane and or the central axis of the device for immobilization of the magnets.

[0084] In the prototypes generated, the magnetic component of the intravesical device comprised one or more cylindrical neodymium permanent rare earth magnets arranged in linear series. The diameter of these cylindrical magnetic components ranged from 3/16” to 1/4" to allow for deformation of the overall device shape into the elongated conformation discussed previously. Example 3

[0085] The forces of attraction and dissociation of multiple prototype sizes, shapes, compositions, and masses were then measured across a range of distances using a purpose-built in vitro testing apparatus utilizing a horizontal ring moveably coupled to the vertical stand at varying distances away from a fixed permanent neodymium magnet. On the horizontal ring was a beaker containing fluid isodense to that of human urine. This setup allowed for the measurement of attractive forces across a range of measurements corresponding to the physiologic variability and dynamism of the human bladder neck and perineum. The results of these experiments, including the distance at which the force of magnetic attraction submerged each prototype, are shown in FIG. 7, and Table 1.

TABLE 1

Example 4

[0086] To determine the feasibility of bladder neck occlusion with the disclosed concept, a 90 kg sheep with no prior urosurgical manipulation was procured immediately following humane sacrifice. The bladder, bladder neck, and urethra were dissected in situ, and the bladder capacity measured at 220 ccs. A prototype comprising a silicone outer membrane, porous hydrophilic internal matrix, and cylindrical neodymium core were inserted via bladder dome cystotomy to avoid damage to the urethra or bladder neck. A three-way urinary catheter allowing for simultaneous filling and pressure measurement were inserted concurrently and sutured into place. The bladder was filled. When the device was paired with an external magnetic field generated by magnets located near the urethral meatus, it seated at the bladder neck and occluded the bladder neck with no urinary leaking at physiologically-relevant pressures of 20 cm H2O. Leakage resumed when the paired magnet was removed and the device was dissociated from the bladder neck. [0087] FIG. 8A illustrates insertion of the prototype in the bladder without the extracorporeal magnet, and FIG. 8B illustrates insertion of the prototype in the bladder with the extracorporeal magnet positioned near the genitals of the sheep. In FIG. 8A, the upward pointed arrow indicates that the disclosed device moves upward with buoyancy force only. In FIG. 8B, the downward pointed arrow indicates that the disclosed device moves downward with the high magnetic force that overcomes the buoyancy force.

Claims

We claim:

1. A deformable intravesical urinary control medical device, comprising: an implant device, comprising: an outer membrane, comprising a material selected from an impermeable material, a semi-permeable material, a self- sealing material, and combinations or blends thereof. an internal cavity formed of the outer membrane, comprising one or more of: an internal matrix, comprising a material selected from low-density gas, fluid, gel, polymer or mixture thereof; an internal structure, comprising a plurality of spindles comprised of an elastic or superelastic material; a magnetic core positioned within the internal cavity; and an extracorporeal magnet, wherein the extracorporeal magnet is positioned in the genital/perineal area of a patient body and provides a magnetic field for caudal attraction of the device.

2. The device of claim 1, wherein the outer membrane comprises a material selected from the group consisting of silicone, latex, polyurethane, expanded polytetrafluoroethylene, and mixtures or combinations thereof.

3. The device of claim 1, wherein the internal structure comprises a plurality of interlocking nitinol spindles forming a structural scaffold.

4. The device of claim 1, wherein the internal matrix comprises a porous hydrophilic matrix capable of hydration for mass calibration.

5. The device of claim 4, wherein the internal matrix comprises a calibration material to allow for calibration of density and balance between the gravitational and buoyant force.

6. The device of claim 1, wherein the magnetic core comprises one or more neodymium permanent magnets arranged in a cylindrical manner.

7. The device of claim 1 , further comprising a locking mechanism to prevent accidental discharge during bladder contraction/micturition.

8. The device of claim 1, wherein said device interconverts between an outer diameter of 5- 10 mm and 15-25 mm.

9. The device of claim 1, wherein said device occupies a volume of 10 to 30 ccs.

10. The device of claim 1, wherein said device has a density from 0.70 to 1.00 g/cc.

11. The device of claim 1, wherein the device further comprises a loop or tag that protrudes from the outer membrane to facilitate cystoscopic removal.

12. The device of claim 1, wherein the extracorporeal magnet attracts the implant device thereby providing occlusion of urinary outflow from the bladder for relief or urinary incontinence.

13. The device of claim 12, wherein the extracorporeal magnet comprises a planar neodymium magnet.

14. The device of claim 12, wherein the extracorporeal magnet comprises an electromagnetic plate.

15. The device of claim 12, where the extracorporeal magnet is embedded within a flexible material.

16. The device of claim 15, wherein the flexible material comprises rubber to facilitate patient comfort.

17. The device of claim 1 , wherein the extracorporeal magnet is attached to a patient’s undergarment.

18. A method of employing the intravesical urinary control device of claim 1, comprising: positioning the implant device in a hollow cylinder comprising a cavity, wherein the implant device deforms into an elongated shape in the cavity; passing the implant device through the cavity, wherein the implant device adopts a new shape/size/density upon exiting the cavity; positioning the implant device into the bladder of a patient body; and positioning the extracorporeal magnet in a genital/perineal area of a patient body.

19. The device in claim 18, wherein the hollow cylinder comprises a piston to extrude the device from the cylinder.

20. The device in claim 18, wherein a guide needle is used to alter the physical characteristics of the device including one or more of size, shape and density.

21. A method of making an intravesical urinary control medical device, comprising: fabricating an implant device, comprising: preparing an outer membrane, comprising: obtaining or manufacturing a pre-shaped metal or polymer mold; and coating the mold with a flexible material to produce the outer membrane, wherein the outer membrane forms an internal cavity; positioning in the internal cavity, one or more of: an internal matrix, comprising a material selected from low-density gas, fluid, gel, polymer or mixture thereof; an internal structure, comprising a plurality of spindles comprised of an elastic or superelastic material; and positioning in the internal cavity a magnetic core; and providing an extracorporeal magnet, wherein the extracorporeal magnet is positioned in the gcnital/pcrincal area of a patient body and provides a magnetic field for caudal attraction of the device.

22. The method of claim 21, wherein the outer membrane has a shape selected from sphere, oblong sphere, cone, bicone, and teardrop.

23. The method of claim 21, wherein the outer membrane comprises silicone.

24. A method of treating a patient for stress urinary or urge urinary incontinence, comprising: preparing a scaffold, comprising: a plurality of supcrclastic or clastic spindles, comprising a biocompatiblc ferromagnetic material; a porous internal matrix, comprising at least one material selected from the group consisting of low-density gas, fluid, gel, and polymer; a magnetic core; and an outer impermeable membrane that encompasses the spindles, internal matrix and magnetic core; interconverting the scaffold into a deploying conformation to form an occlusive scaffold; positioning by transurethral insertion the occlusive scaffold into a bladder lumen of the patient; and positioning the occlusive scaffold in an open configuration, wherein the diameter of the device is sufficient to occlude the bladder outlet of the patient to prevent stress urinary or urge urinary incontinence.

25. The method of claim 24, further comprising pairing the scaffold with an extracorporeal magnet positioned in the gcnital/pcrincal area of the patient body and provides a magnetic field for caudal attraction of the device.

26. The method of claim 25, wherein the extracorporeal magnet is positioned within an undergarment worn by the patient.

27. A testing device to assess multiple shapes, sizes, and magnetic contents of an intravesical urinary control medical implant device ex vivo, including a vertical stand; a horizontal ring moveably coupled to the vertical stand; and 3-D printed models of human bladder comprising firm, malleable, or flexible plastic or rubber, wherein the horizontal ring is structured to contain the 3-D printed models of human bladder, to optimize the medical implant device size/shape to an individual’s bladder anatomy at varying stages of filling. In certain embodiments, the height of the ring on the vertical stand is variable to allow for calibration of magnetic fields to achieve desired or selected buoyancy. In certain embodiments, the testing device further includes one or more of a newton meter and an optical location tracker, and/or a modelled bladder outlet/urethra through which fluid placed in the model can efflux, allowing for the testing of the device under physiologic conditions. The human bladder may be in both an open and closed system to allow for the controlled generation of hydrostatic pressure to mimic bladder contractions to test for urinary leakage over a variety of pressures.

28. The testing device of claim 27, wherein the height of the ring on the vertical stand is variable to allow for calibration of magnetic fields to achieve desired or selected buoyancy.

29. The testing device of claim 27, further comprising one or more of a newton meter and an optical location tracker.

30. The testing device of claim 27, further comprising a modelled bladder outlet/urethra through which fluid placed in the model can efflux, allowing for the testing of the device under physiologic conditions.

31. The testing device of claim 27, further with a scale beneath the device to assess the flow of urine through a modelled or explanted bladder can be tested.

32. The testing device of claim 27, wherein the human or mammalian bladder is in both an open and closed system to allow for the controlled generation of hydrostatic pressure to mimic bladder contractions to test for urinary leakage over a variety of pressures.