WO2022026035A1

WO2022026035A1 - Implantable infusion devices, access devices and methods

Info

Publication number: WO2022026035A1
Application number: PCT/US2021/033154
Authority: WO
Inventors: Jolene Cutts; Thang Hoang; Romain Roux; Daniel R. Burnett
Original assignee: Perikinetics Inc
Current assignee: Perikinetics Inc
Priority date: 2020-07-28
Filing date: 2021-05-19
Publication date: 2022-02-03
Anticipated expiration: 2023-01-28

Abstract

Implantable port devices, access devices and methods are described herein. An assembly may generally comprise a needle having an insertion portion and a lumen. An infusion set housing may have a channel defined at least partially through the infusion set housing between a first opening defined along a peripheral portion and a second opening defined along a securement surface. The infusion set housing is securable to a skin surface of a subject along the securement surface, and an actuator roller is removably positioned in proximity to the second opening of the infusion set housing and contacted against the needle. Actuation of the actuator roller imparts a curvature along the needle. A length of the insertion portion of the needle may be adjustable relative to the second opening to accommodate a variable insertion depth of tissue underlying the second opening when the securement surface is secured to the skin surface.

Description

IMPLANTABLE INFUSION DEVICES, ACCESS DEVICES AND METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Application 63/057,424 filed July 28, 2020 and U.S. Provisional Application 63/107,264 filed October 29, 2020, each of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] The present invention relates to infusion devices and continuous analyte measuring devices.

INCORPORATION BY REFERENCE

[0003] All publications and patent applications mentioned in this specification are herein incorporated by reference in entirety to the same extent as if each such individual publication or patent application were specifically and individually indicated to be so incorporated by reference.

BACKGROUND OF THE INVENTION

[0004] Diabetes is a group of diseases characterized by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. Diabetes is the leading cause of blindness in people ages 20 to 70 and is sixth leading cause of death in the United States. Overall, the risk for early death among people with diabetes is about 2 times that of people without diabetes. The disease often leads to other complications such as kidney, nerve and heart disease and strokes. It is the leading cause for non-traumatic amputations and kidney failure.

SUMMARY OF THE INVENTION

[0005] The intraperitoneal (IP) space has been shown to have more effective, faster insulin delivery and faster glucose sensing kinetics than the subcutaneous space. The peritoneum, a thin transparent membrane that lines the walls of the abdominal cavity, contains the abdominal organs. The fluids within the peritoneum are constantly exchanged by blood exudate. By comparison, subcutaneous tissues are located just below the skin surface and experience much lower blood perfusion rates. The IP space provides superior kinetics and a better medium for real-time glucose measurement and insulin delivery, than does the subcutaneous space.

[0006] Any of the embodiments detailed herein can be used in any potential space, including, but not limited to, the pleural space, the cerebral spinal fluid space, the peritoneal space, the true pelvis, etc.

[0007] Because the peritoneal cavity is deeper within the body than the subcutaneous space, accessing the peritoneal cavity for delivery of insulin and/or sensing of glucose has its challenges. Disclosed herein are various embodiments of a peritoneal access system which allows for ongoing access to the peritoneal cavity, for insulin delivery, and in some cases, glucose sensing.

[0008] The peritoneal access system may include an implanted subcutaneous port which is connected to a catheter or tube which is in communication with the peritoneal cavity. The port may be accessible by a needle through the skin. The needle through the skin may be in communication with an insulin pump and may remain in the port for several days at a time or longer. In this way, the insulin delivery to the peritoneal cavity may be controlled with an insulin pump, without frequent needle sticks. In some embodiments, the system may deliver insulin only, and in some embodiments, the system may include glucose sensing. In some embodiments, insulin is delivered to the true pelvis.

[0009] Important differences between the embodiments disclosed herein and products currently available include: a. A subcutaneous port which provides access to the peritoneal cavity. b. The ability to access the subcutaneous port continually and for long time periods, such as hours, days, weeks or months. c. The ability to accommodate subjects with significantly different skin and/or fat thicknesses. d. The ability to accommodate some relative movement of the needle within the subcutaneous port over time. e. The ability to secure the subcutaneous port so that it is relatively stable within the anatomy while it is implanted. f. Very low level of infections since only a needle or other conduit is crossing the skin barrier. g. The ability to use with external pumps, such as an external insulin pump. h. The ability to locate the subcutaneous port and accurately place the needle within the reservoir of the port.

[0010] In one variation of an infusion assembly, the assembly may generally comprise a needle having an insertion portion and defining a lumen therethrough, an infusion set housing having a channel defined at least partially through the infusion set housing between a first opening defined along a peripheral portion of the infusion set housing and a second opening defined along a securement surface where the infusion set housing is securable to a skin surface of a subject along the securement surface, and an actuator roller removably positioned in proximity to the second opening of the infusion set housing and contacted against the needle, whereby actuation of the actuator roller imparts a curvature along the needle proximally of the insertion portion such that a proximal portion of the needle is positionable through the channel. A length of the insertion portion of the needle may be adjustable relative to the second opening to accommodate a variable insertion depth of tissue underlying the second opening when the securement surface is secured to the skin surface. [0011] In one method of adjustably inserting a needle, the method may generally comprise positioning a securement surface of an infusion set housing along a skin surface of a subject, the infusion set housing defining a channel at least partially through the infusion set housing between a first opening defined along a peripheral portion of the infusion set housing and a second opening defined along the securement surface, advancing an insertion portion of a needle to a predetermined depth beyond the skin surface, adjusting a length of the insertion portion relative to the second opening to accommodate a variable insertion depth of tissue underlying the second opening, and imparting a curvature along the needle proximally of the insertion portion such that a proximal portion of the needle is positionable through the channel.

[0012] In another variation of an infusion assembly, the assembly may generally comprise a needle having an insertion portion and a curved portion and defining a lumen therethrough, an infusion set housing having a channel defined at least partially through the infusion set housing between a first opening defined along a peripheral portion of the infusion set housing and a second opening defined along a securement surface of the housing where the infusion set housing is securable to a skin surface of a subject along the securement surface, and a needle roller ball movably positioned within the channel and connected to a proximal end of the needle as the insertion portion extends through the second opening, wherein the needle roller ball is configured to slide or rotate within the channel while remaining connected to the proximal end of the needle to accommodate a movement of the needle relative to the infusion set housing when the securement surface is secured to the skin surface.

[0013] In another method of adjustably inserting a needle, the method may generally comprise positioning a securement surface of an infusion set housing along a skin surface of a subject, the infusion set housing defining a channel at least partially through the infusion set housing between a first opening defined along a peripheral portion of the infusion set housing and a second opening defined along the securement surface, advancing an insertion portion of a needle to a predetermined depth beyond the skin surface, and imparting a curvature along the needle proximally of the insertion portion such that a proximal portion of the needle is positionable through the channel, wherein the needle is configured to accommodate a movement of the needle relative to the infusion set housing when the securement surface is secured to the skin surface.

BRIEF DESCRIPTION OF THE DRAWINGS [0014] Fig. 1 shows an embodiment of the peritoneal access system.

[0015] Fig. 2 shows an embodiment of a peritoneal insulin delivery system.

[0016] Fig. 3 shows detail of a subcutaneous port.

[0017] Fig. 4 shows an embodiment of a subcutaneous port with a large reservoir.

[0018] Figs. 5A and 5B show an embodiments of subcutaneous ports with a deep reservoirs.

[0019] Fig. 6 shows an embodiment of a subcutaneous port with a septum with a larger surface area.

[0020] Figs. 7 and 8 show an embodiment of the insulin delivery system where the needle is removed after the patch has been placed on/in the skin.

[0021] Fig. 9 shows an embodiment which combines insulin delivery and peritoneal cavity sensing.

[0022] Figs. 10A and B show embodiments of the insulin delivery system which may be particularly useful with overweight patients. [0023] Figs. 11A-C show embodiments of the insulin delivery system which may incorporate flushing of the system, as well as analyte sensing of fluid within the peritoneal cavity.

[0024] Figs 11D-E show embodiments of the insulin delivery system which incorporate a separate flushing reservoir and lumen.

[0025] Figs 11F-I show embodiments of the insulin delivery system which incorporate a smart needle and/or cannula.

[0026] Figs. 12A-E show various embodiments of the insulin delivery system which include features to help maintain the needle 814 within the reservoir of the subcutaneous port.

[0027] Figs. 13A-C show embodiments that incorporate a mesh in the subcutaneous port. [0028] Figs. 14A-F show alternative needle capture embodiments of the insulin delivery system.

[0029] Figs. 15A-B show an embodiments incorporating a balloon/expandable member. [0030] Figs. 15C and 15D show an embodiment that includes a shape memory needle. [0031] Figs. 15E-G show an embodiment utilizing a locking needle.

[0032] Figs. 16A and B show an embodiment of a piercable septum.

[0033] Fig. 17 shows an embodiment of the port which includes a foam insert.

[0034] Figs. 18A-18C show various embodiments of the distal tip of a peritoneal catheter. [0035] Figs. 19A and 19B show an embodiment of the skin patch which includes a “folding” needle.

[0036] Fig. 20 shows an embodiment of the subcutaneous port which includes a hydrophilic layer.

[0037] Figs. 21A-21D show various views of an embodiment of a subcutaneous port.

[0038] Figs. 22A shows an embodiment of the patch portion of the device which accounts for movement between the skin and the subcutaneous port.

[0039] Fig. 22B shows some of the possible degrees of freedom between the infusion set and the subcutaneous port provided by embodiments disclosed herein.

[0040] Fig. 23 shows an actuator housing which stabilizes the needle portion of the body patch shown in Fig. 22A. [0041] Fig. 24 shows an embodiment of an actuator/infusion set combination which performs several functions.

[0042] Figs. 25A and 25B show the actuator portion of the combination shown in Fig. 24. [0043] Figs 26 A-C show the infusion set portion of the combination shown in Fig. 24. [0044] Figs. 27A-B show the needle insertion process using the actuator and the infusion set.

[0045] Figs. 28A and 28B show the needle bending step, which accommodates different needle lengths, which accommodates different skin/fat thicknesses, and different distances between the infusion set and the subcutaneous port.

[0046] Figs. 29 A-C show the needle being placed in position for compliance.

[0047] Fig. 29D shows the infusion set after the needle has been inserted and bent, and the actuator has been removed.

[0048] Fig. 29E shows the infusion set with the infusion set cap in place.

[0049] Figs. 30A-C show detail of the infusion set.

[0050] Figs. 31 A-C show other possible designs which provide needle compliance, or degrees of freedom of movement.

[0051] Figs. 32A-E show the insertion process of the design with a flexible needle, as shown in Fig. 3 IB.

[0052] Figs. 33A-E show the insertion process of the design with flexible tubing as shown in Fig. 31C.

[0053] Figs. 34A-F show the insertion process of the design with a bobble or tracker ball as shown in Figs. 22A and 23.

[0054] Figs. 35A - 35D shown embodiments of the subcutaneous port which include tissue in-growth areas.

[0055] Figs. 36A-D show a guide which may be used to help align the infusion set with the subcutaneous port.

[0056] Fig. 37 shows a block diagram of a data processing system, which may be used with any embodiments of the invention. DETAILED DESCRIPTION OF THE INVENTION

[0057] Some embodiments of the access system include a subcutaneous port and skin patch, or infusion set, which can accommodate some relative movement between the infusion set and the subcutaneous port, which may be caused by skin movement associated with normal daily activities. Because the infusion set and the subcutaneous port are connected to each other via a needle over some period of time, it is likely that there will be some relative movement as the user goes about his/her life. This movement may be around 0.25” of movement of the infusion set relative to the subcutaneous port in any direction, including the x, y and z directions. The movement of the infusion set relative to the subcutaneous port may also or alternatively be rotational. Some embodiments disclosed herein allow relative movement between the infusion set and the subcutaneous port in the transverse directions and/or the up and down directions and/or rotational directions.

[0058] Some embodiments of the access system include a subcutaneous port and skin patch, or infusion set, which can accommodate varying distances between these two components, to accommodate users of different skin and/or fat thicknesses, which allowing the infusion set to sit relatively flat against the skin. Since skin and/or fat thickness may vary across users, and the tip of the needle is designed to reside in the reservoir of the subcutaneous device during use, it may be necessary to accommodate different needle lengths. In this way, the needle length and/or distance between the infusion set and the subcutaneous reservoir, can be patient-specific. Some embodiments disclosed herein include this feature.

[0059] Because movement of the subcutaneous port, once implanted, can hinder the tissue healing response and make needle access into the port challenging, it is desirable to fix the subcutaneous port in position so that there is relatively no movement and/or migration of the subcutaneous port after implantation. Relative motion between this fixed port and the external infusion set that resides on the skin can also be problematic. This relative motion can place stress on the needle of the infusion set or cause it to dislodge/disconnect from the port entirely. Therefore stabilizing the tissue around the port can minimize the motion of the infusion set relative to the port. Some embodiments disclosed herein include features which provide this stabilization.

[0060] Fig. 1 shows an embodiment of the peritoneal access system. Shown here is insulin pump 102, peritoneal cavity 104, subcutaneous port 106, infusion tubing 110, skin patch (or infusion set) 112, needle/cannula access device 114, and peritoneal tubing/catheter 116, which is in fluid communication with the peritoneal cavity. Subcutaneous port is implanted beneath the skin of the subject. Here, it can be accessed through the skin via needle 114. The subcutaneous port is in fluid communication with catheter 116. Insulin pump 102 is in fluid communication with infusion tubing 110 which is in fluid communication with needle 114, which is in fluid communication with subcutaneous port 106 (via a reservoir, not shown) and with catheter 116 and ultimately the peritoneal cavity. Needle 114 is held in place for hours, days, or weeks at a time via skin patch 112. The system allows insulin, or any other fluid and/or drug, to be delivered directly to the peritoneal cavity on a long term, either continuous or intermittent, basis, with minimal risk of infection since the only component passing through the skin is a very thin sterile needle held in place flush to the skin and protected by an adhesive patch.

[0061] Fig. 2 shows an embodiment of a peritoneal insulin delivery system. In this embodiment, insulin pump 202 pumps insulin into peritoneal cavity 204. Subcutaneous port 206 is implanted in or under tissue layers 208, which includes skin, fat and muscle. Insulin pump 202 is fluidly connected to infusion tubing 210 which can be connected to patch 212 which may be adhered to the outside of the skin. Patch 212 includes needle or cannula or access device 214 which pierces the skin and enters subcutaneous port 206. Needle 214 is in fluid communication with tubing 210. The patch with needle 214 may worn for a period of time, for example, days, and may be removed and replaced with a different patch/needle. The subcutaneous port is designed to remain implanted for a longer period of time, for example 1-3 months, or 3-6 months, or 6-12 months, or more than 1 year.

[0062] The insulin pump is meant to be worn on the subject’s body /clothing so that the subject may be ambulatory. The pump is generally meant to be worn at all times, except when the system is being replaced, flushed, etc., or the needle/patch is being replaced. [0063] Subcutaneous port 206 includes reservoir 218 which is in fluid communication with needle 214 and implanted insulin delivery tubing or catheter 216. Delivery tubing may include Dacron cuff 222. In this way, insulin 220 may be delivered to peritoneal cavity 204 from insulin pump 202.

[0064] Preferably, needle 214 is a non-coring needle, such as a Huber needle. In some embodiments the needle may have more than one outlet port so that the likelihood of it being blocked is reduced.

[0065] Fig. 3 shows more detail of an embodiment of subcutaneous port 206. The subcutaneous port includes pierceable septum 302 and reservoir 218. The septum may be made out of silicone rubber, other rubber, or other suitable material(s), including polymer component(s). Preferably, the septum “reseals” after a needle/cannula has been removed. It is also preferable that the septum be able to be pierced multiple times and possibly in multiple locations and at different angles.

[0066] Reservoir 218 may be of various sizes and shapes. Shown in Fig. 3 is a tapered reservoir which helps guide the needle tip into the base of the reservoir. The angle of the tapered reservoir may be different than the angle of the needle so that the hole of the needle does not get blocked by the wall of the reservoir. For example, the angle of the needle tip may be less than the angle of the taper of the wall. Alternatively, the angle of the needle tip may be greater than the angle of the taper of the wall of the reservoir.

[0067] Fig. 4 shows a larger, cylindrical shaped reservoir.

[0068] The volume of the reservoir may be designed to be as small as possible to minimize the volume of insulin held at body temperature enroute to the IP cavity. It may also be desirable to minimize insulin remaining t in the reservoir after insulin pumping. For example, the volume of the reservoir may be about 1-10 mm3. Alternatively, the volume of the reservoir may be about 10-50 mm3. Alternatively, the volume of the reservoir may be about 50-100 mm3. Alternatively, the volume of the reservoir may be about 100-1000 mm3. Alternatively, the volume of the reservoir may be about 1000-10000 mm3.

[0069] Alternatively or additionally, the volume of the reservoir may be designed with a precise and known volume so that insulin delivery volumes may be calibrated to compensate for any stagnant insulin volume in the reservoir. Alternatively, a flushing mechanism may be used to flush the reservoir of any insulin when a precise volume of insulin is pumped from the insulin pump into the peritoneal cavity.

[0070] Fig. 5A shows a subcutaneous port with a deeper reservoir which ensures that the tip of the needle will reside in the reservoir after the patch has been secured to the skin.

This deeper reservoir allows for more variation in the depth of the port implantation. For example, the reservoir may be l-5mm deep, alternatively the depth of the reservoir may be 10- 15mm, alternatively the depth of the reservoir may be 5- 10mm, alternatively the depth of the reservoir may be 15-20mm. This flexibility may be useful with patients of different fat depths.

[0071] Fig. 5B shows a subcutaneous port with multiple deep reservoirs which ensures that the tip of the needle will reside in a reservoir after the patch has been secured to the skin. In this embodiment, each reservoir may include a one-way valve. The small reservoirs also help minimize the dead volume of insulin within each reservoir channel that is exposed to body temperature.

[0072] Some embodiments may include a mechanism which ensures the implantation of the port is performed at a precise depth below the skin surface.

[0073] Fig. 6 shows a subcutaneous port with a septum with a larger surface area and possibly a reservoir with a larger area interface with the septum. The patch shown in Fig. 6 also includes an angled needle, although a straight needle, as shown in Fig. 5, may also be used. The advantage of using an angled needle is that when a new patch is applied to the skin, the needle may be positioned in a slightly different orientation than the previous times which avoids piercing the septum, and skin, in the same place. Another advantage is that the same length needle may be used with subjects with different skin/fat thicknesses, by introducing the needle at different angles, depending on the skin/fat thickness. In this embodiment, the surface area of the septum may be around 100 mm2 to 150 mm2. Alternatively, the surface area of the septum may be around 150 mm2 to 200 mm2.

Alternatively, the surface area of the septum may be around 200 mm2 to 300 mm2.

Alternatively, the surface area of the septum may be around 300 mm2 to 400 mm2.

Alternatively, the surface area of the septum may be around 400 mm2 to 500 mm2.

Alternatively, the surface area of the septum may be around 500 mm2 to 1000 mm2. Alternatively, the surface area of the septum may be over 1000 mm2.

[0074] Figs. 7 and 8 show an embodiment of the insulin delivery system where needle 214 is removed after the patch has been placed on the skin. In this embodiment, needle 214 is removed, and flexible cannula 702 is left behind. Cannula 702 is in fluid communication with infusion tubing 210 and reservoir 218. Having a cannula remain in place instead of a needle may minimize discomfort for the user, as well as ongoing damage to the septum and subcutaneous port caused by body movement over time. A flexible cannula may also accommodate different subject skin fat thicknesses, since it can be bent at different locations and placed flat against the skin. The cannula may be made from any appropriate material, including polyethylene, silicone, polyimide, polymer, etc. The cannula may be reinforced, for example with a metal braid within the wall, on the interior or the exterior of the cannula to prevent kinking. The cannula may be designed to be bent/angled, without kinking, so that it can accommodate different fat/skin thicknesses.

[0075] Fig. 9 shows an embodiment which combines insulin delivery and peritoneal cavity sensing, such as glucose sensing. In this embodiment a double lumen needle 902, or 2 separate needles may be used. The needle lumens may enter the same reservoir (as shown here), or 2 separate reservoirs. In the case of a shared reservoir, tubing/catheter 906 may be used for both insulin delivery and peritoneal cavity fluid sampling to determine glucose levels and may have one or more lumens. Alternatively, 2 different catheters may be used. The lumen of infusion tubing 210 is in fluid communication with one of the needle lumens, and sampling tubing 904 is in fluid communication with the second needle lumen.

Sampling tubing 904 is in fluid communication with a peritoneal sensor system (not shown) to sense the amount of glucose in the sample from the peritoneal cavity. Alternatively the sensor system may be implanted.

[0076] Figs. 10A and B show embodiments of the insulin delivery system which may be particularly useful with overweight patients, but may be used on any patients. In patients where the fat layer is thicker than normal, as shown in Fig. 10A, subcutaneous port 206 may be attached to the under layer of the skin (dermis), with sutures, glue, staples or other suitable mechanism. In this way, the location of reservoir 218 with respect to the outer surface of the skin is relatively small and predictable. Fig. 10B shows an embodiment of the insulin delivery system where the subcutaneous port is designed to be implanted near ribs 1002. The subcutaneous port may be secured to at least one rib, or may be secured near the rib or ribs, using the rib(s) for stability. Generally, a patient has less fat near the ribs as well.

[0077] Figs. 11A-C show embodiments of the insulin delivery system which may incorporate flushing of the system, as well as analyte sensing of fluid within the peritoneal cavity. This embodiment includes patch 1102 over subcutaneous port 206. Patch 1102 is similar to patch 212 disclosed in other embodiments disclosed herein. Patch 1102 may include connector 1104 to connect to connector tubing 1106 which connects to supplemental patch 1108 which may also be affixed to the skin of the subject/patient. Connector 1110 may connect to insulin pump 202, flushing mechanism 1112, sensing system 1114, or a device that include two or all of the pumping, flushing and sensing functions.

[0078] Insulin pump 202 may be connected to the system to deliver insulin into the peritoneal cavity as disclosed elsewhere herein.

[0079] Occasionally, the system, and especially catheter/tubing 2506, may need to be flushed to prevent and/or eliminate clogs. Generally it is undesirable to flush all the insulin residing in reservoir 218 into the peritoneal cavity to flush the system, because of the physiological effects. Embodiments that include a flushing mechanism may include a mechanism to first pull fluid into tubing/catheter 2506from the peritoneal cavity. The peritoneal fluid displaces the insulin inside tubing/catheter 2506, reservoir 218, needle 214, patch 1102, connector tubing 1106, and supplemental patch 1108. After the insulin in these components has been replaced with peritoneal fluid, the system may be flushed with saline or other appropriate fluid. Flushing mechanism 1112, for this reason, may have the ability to pull suction (apply negative pressure) and also apply positive pressure to the system. [0080] Sensing system 1114 may be incorporated into the flushing system and/or the insulin pump. Sensing system includes an analyte sensor, such as a glucose sensor, to sense the analyte/glucose in the peritoneal fluid. This sensing may occur in conjunction with the flushing process, after the peritoneal fluid has been drawn into the system.

[0081] Flushing system 1112 and sensing system 1114 may be incorporated into one system. They may also each or both be incorporated into a single system with the insulin pump.

[0082] Before insulin delivery can be initiated again after flushing the system and/or sensing an analyte in the peritoneal fluid, or when the insulin pump is first connected, the system may need to be primed with insulin. This will allow any incremental volume of insulin pumped from the pump into the system to enter the peritoneal cavity. One method of priming the system is to pump precisely the volume of insulin necessary to fill the system. This would include the volume inside tubing/catheter 2506, reservoir 218, needle 214, patch 1102, connector tubing 1106, and supplemental patch 1108. This may also include the volume inside infusion tubing 210 connected to the infusion pump. Or, alternatively, tubing 210 may not need to be primed if it is still full of insulin from when it was disconnected from the system.

[0083] A supplemental patch is shown here to increase the convenience of making repeated connections. In this way, any connections (to flush, sense, deliver insulin, bath, wash etc.) can be made at connection point/connector 1110 instead of connection point/connector 1104. This helps protect patch 1102 from repeat stresses that may loosen or adversely affect the sterile connection through the skin via needle 214, allowing patch 1102 to stay in place for a longer period of time. Alternatively, supplemental patch 1108 may not be present and the various systems (pump, flushing mechanism, sensing mechanism) may be connected via connector 1104. [0084] Alternatively, flushing of the system can be performed by monitoring the volume of insulin in the system (via the controller), and when the flushing time approaches, begin infusing flushing solution instead of insulin when insulin dosing is required. The flushing solution will push the insulin out of the system incrementally with each infusion at an approximately 1:1 volume ratio. So, for example, if 0.15 ml of insulin is required, approximately 0.15 ml of flushing solution will be infused into the system to push out a corresponding 0.15 ml of insulin. When the insulin in the system is depleted, or nearly depleted, the system may then initiate a flush sequence to remove any blockages in the system. The advantage to this approach is that insulin does not need to be removed from the system using a separate mechanism in order to flush the system. Depending on the volume of the system, the introduction of flushing solution instead of insulin may begin hours or even days before the actual flush sequence is performed.

[0085] Alternatively, flushing of catheter 216 may be performed via a different lumen than the insulin lumen. For example, as shown in Fig 1 ID, port 206 may include more than one reservoir, one for insulin, insulin reservoir 218, and one for flushing solution, flushing reservoir 1118. The reservoir for flushing solution is in fluid communication with flushing lumen 1120 of catheter 216, shown here as defined by sheath 1122. Flushing lumen 1120 may alternatively not be part of catheter 216. The flushing lumen may be concentric with (i.e. outside of, as shown here) or next to, the insulin lumen of catheter 216. The flushing reservoir in the port may be accessed directly with syringe 1124, as shown here, or may be in fluid communication with a flushing fluid pump external to the body and preferably controlled by the controller.

[0086] Alternatively, a second reservoir/port for flushing may be implanted and in fluid communication with the flushing lumen of the catheter, as shown in Fig. 1 IE. Here, flushing port 1126 contains the flushing reservoir and can be accessed via a syringe, as shown here, or via a pump.

[0087] The distal end of the flushing lumen may be flush with, distal to, or proximal to the distal end of catheter 216.

[0088] In some embodiments, insulin may be used to flush the catheter. This would need to be achieved with very small volumes of insulin, requiring a very small opening of the insulin lumen of the catheter to achieve adequate pressure/flow to flush the tip of the catheter. [0089] In some embodiments the distal tip of the catheter may be cleaned by occasionally physically collapsing the distal end of the catheter, breaking the bond with any adhesions. This may be done by occasionally applying a negative pressure to the distal end of the catheter. This may be done by pulling a vacuum on the system via the controller.

[0090] Figs. 11B and 11C show possible embodiments of the tip of tubing/catheter 2506which allow peritoneal fluid to be withdrawn into the catheter/tubing from the peritoneum. Openings 1116, which may be arranged around the distal tip of the tubing/catheter so that at least one will remain open regardless of the position of the tubing /catheter within the peritoneal cavity. The catheter/tubing may include a distal opening as well, as shown in Fig. 11B, or have a closed, possibly rounded distal end, as shown in Fig. llC.

[0091] Fig 11F shows an embodiment of the system which includes both insulin (or other fluid) injection and glucose (or other analyte) sensing. In this embodiment, controller 1128 may perform both the insulin injection and glucose monitoring function, or the functions may be separate. Controller 1128 may be closed-loop or semi closed-loop. For example, the injection of insulin may be solely driven by the sensed glucose levels, or may be partially driven by the sensed glucose levels. The user may be able to override or augment the insulin delivery based on other factors, such as how the user feels, or what the user eats. The closed-loop function may make only small adjustments to insulin levels and not large adjustments, or may make all or most adjustments automatically.

[0092] Glucose sensing may be performed by drawing peritoneal fluid from within the peritoneal cavity either into subcutaneous port 1130 or into controller 1128, or elsewhere outside of the body, where a glucose sensor senses the glucose within the fluid. Alternatively, glucose sensor 1134 may be on catheter 1132 as shown here. In the embodiments where the glucose sensor is incorporated into the catheter, or the port, an electrical connection between the controller and the sensor may be required. This may be achieved via smart needle 1136, or may be achieved wirelessly or by other mechanisms. [0093] Figs. 11G-11I show various embodiments of the system which includes a smart needle, or a smart needle/cannula which achieves an electrical connection between the controller and an implanted sensor. In addition, the smart needle/cannula may have the ability to infuse and/or extract a fluid. Both the electrical connection and the infusion may be achieved by inserting the smart needle/cannula into a smart subcutaneous port. Some embodiments achieve this with a single stick, via a single needle or a single needle/cannula combination. [0094] Fig. 11G shows an embodiment of a smart needle system which includes smart needle 1138 and smart subcutaneous port 1140. In this embodiment, the smart subcutaneous port includes multiple conductive mesh sheets 1142. These mesh sheets may be similar to those disclosed in Fig. 13B. These mesh sheets are connected to electrical connector 1144 which is in electrical communication with a sensor, such as a glucose sensor, on the catheter, or elsewhere in the implanted system. Needle 1138 includes conductive portions 1146 and insulated portions 1148. The distal and proximal insulated portions may extend to the ends of the needle, or only insulate a portion of the proximal and distal ends of the needle. The conductive portions of the needle are in electrical communication with the controller.

[0095] The mesh sheets in this embodiment are conductive, so that when a conductive portion of the needle is in physical contact with one of the conductive mesh sheets, the controller is in electrical communication with the sensor on the catheter or elsewhere in the system. One, two, or more electrical contacts may be present between the controller and the sensor, via the needle and the conductive mesh sheets. Two electrical connections are shown here.

[0096] The conductive mesh sheets and conductive areas on the needle may be arranged so that one, two, or another number of electrical contacts can be made at different needle depths, for example, with patients with different fat layer thicknesses. The smart needle may have more conductive surfaces than the number of conductive mesh sheets in the port, or the smart needle may have fewer conductive surfaces than the number of conductive mesh sheets in the port, as shown here.

[0097] Fig. 11H and 111 show an embodiment of a smart needle which includes a smart cannula. In this embodiment, needle 1152 contains (or is contained by) cannula 1150. Fig. 11H shows the smart cannula within the needle as the needle is inserted into the smart subcutaneous port. In this embodiment, the cannula includes conductive and insulated portions. The needle may also include conductive and insulated portions, or it may not. To place the cannula, the needle is either inserted a set distance, or as far as it can be so that it bottoms out. Alternatively the needle is inserted past a set point, to make sure that the needle is in the reservoir of the port. The needle is then removed, while the cannula remains in place, as shown in Fig. 111. The cannula may be pulled back slowly until the conductive portion(s) of the cannula is in contact with the conductive mesh(es) of the smart port. The smart cannula may be flexible or rigid, made out of any suitable material such as metal, or polymer.

[0098] One of the conductive portions of a smart needle or smart cannula may serve as a ground electrode.

[0099] Conductive meshes are shown here, but other electrical contacts are envisioned, including nodes, surfaces, protrusions etc. within the reservoir of the port.

[0100] In some embodiments, the controller can identify when the smart needle/cannula is in the desired position in the smart port, with one or two or more conductive portions of the smart needle/cannula in electrical contact with one or two or more conductive portions (i.e. conductive mesh) of the port. For example, the controller may analyze the resistance or conductivity between two electrodes on the smart needle/cannula to determine if the smart needle/cannula is in air, in skin, in fat, in other tissue, in the incorrect position within the port, or in the correct position within the port. The conductivity /resistance between two conductive portions (also referred to as electrodes) may be as follows:

[0101] - The smart needle/cannula is in air - the resistance may be very high, or the conductivity low.

[0102] - The smart needle/cannula is correctly positioned in the port - the conductivity/resistance may be set to be a specific value, so that this condition is easily identified.

[0103] - The smart needle/cannula is in skin or fat or other tissue, or incorrectly positioned in the port - the resistance/conductivity may be different than that when the smart needle/cannula is in air or correctly positioned in the port.

[0104] The mesh may be flat, or curved. The mesh may be parallel to the surface of the port or may be at an angle to the surface of the port.

[0105] The smart needle or smart cannula may be hollow, as shown here, or may be solid. [0106] In any of the embodiments disclosed herein, the sensing of glucose and/or delivery of insulin, may be subcutaneous, rather than in the peritoneal cavity.

[0107] Some embodiments may include a registration mechanism in the port (and/or the needle) which captures the tip of the needle, or prevents the tip of the needle from advancing further or prevents the needle from withdrawing before the user is ready to remove the patch. Some embodiments may include a lock, such as a ball/socket or twist lock. The lock may include a magnetic component. The lock may provide feedback to the user when the needle is correctly placed within the reservoir of the subcutaneous port. For example, there may be audible, hepatic, visual or other feedback.

[0108] Figs. 12A-E show various embodiments of the insulin delivery system which include features to help maintain needle 214 within reservoir 218 of subcutaneous port 206. Fig. 12A shows an embodiment where needle 214 includes small annular protuberance 1202 which is small enough to allow the needle to pierce the skin and pierceable septum 302, but is large enough that the needle does not easily slide out of its position within the subcutaneous port because the pierceable septum “seals” around the smaller part of the needle. The protuberance may be on the outside of the needle, or may be constructed into the wall of the needle itself. In other words, the ID of the needle may or may not include an inverse protuberance. Embodiments may include one or more small annular protuberances.

[0109] Fig. 12B shows an embodiment where the needle includes small annular notch or indent 1204, similar to that of a post-style earring. In this embodiment the septum may include a plate, or mesh 1206, either embedded in the septum, or on either side of the septum (preferably the reservoir side). The mesh may help prevent the needle from easily slipping out of the reservoir, in the same way a post-style earring back prevents an earring from coming out of an earlobe. More details on possible mesh embodiments are disclosed in Figs. 13A-C. The indent may be on the outside of the needle, or may be constructed into the wall of the needle itself. In other words, the ID of the needle may or may not include an inverse indent. Embodiments may include one or more small annular notches.

[0110] Fig. 12C shows an embodiment where the needle includes small non-annular protuberance 1208. This may be a simple “blob” or bump on one side of the needle. The bump may be on the outside of the needle, or may be constructed into the wall of the needle itself. In other words, the ID of the needle may or may not include an inverse protuberance. Embodiments may include one or more bumps.

[0111] Fig. 12D shows an embodiment where the needle includes irregularity, bend, or curvature 1210. This curvature is preferably constructed into the wall of the needle itself, for example, by adding a bend to a straight needle. Embodiments may include one or more bends, for example, see Fig. 12E for a needle with multiple bends.

[0112] Any of the needle feature embodiments may be used with a mesh. Fig. 13 A shows an embodiment with mesh 1206 incorporated into the reservoir side of septum 302. Fig. 13B shows an embodiment with multiple meshes. Note that the mesh(es) may or may not extend to the edges of the septum. The mesh(es) are generally large enough to cover the area of the top of reservoir 218.

[0113] Fig. 13C shows some examples of mesh designs. The openings in the mesh may be regular or irregular, larger or smaller than the needle. The mesh may be made out of metal, polymer, wire, foam, or any other suitable material.

[0114] Figs. 14A-F show alternative needle capture embodiments of the insulin delivery system. Fig. 14A includes a needle with threads 1402 incorporated into the wall of the needle. This embodiment can be advanced through the skin and through the septum using a rotational force, like a screw. Once the needle is in place in the reservoir, and the patch is applied to the skin, the needle is unlikely to be able to slide back and forth across the septum because of the threads. The patch prevents any rotation of the needle with respect to the subcutaneous port/septum.

[0115] Fig. 14B shows an embodiment similar to that in Fig. 14A except that the threads are added to the outside of the needle. In some embodiments, a hydrophilic, or other polymer may be placed between the coils so that the outer surface of the needle is smooth. In these embodiments, the polymer may swell over time, or once it is in place in the reservoir. This swelling will create a non-smooth surface which will prevent the needle from coming out accidentally, but will still allow the needle to be removed with some small force.

[0116] Figs. 14C and 14D show an embodiment which includes cannula 1406, similar to the cannula shown in Figs. 7 and 8. The cannula is left behind after the needle is removed. In this embodiment, the cannula is made out of swelling material, such as a hydrophilic polymer, and its OD swells slightly over time after it has been placed into the reservoir. The ID of the swelling cannula remains large enough to infuse insulin. The entire length of the cannula may be made of a swelling material, or only a portion. A swelling material may be added to a needle as an alternative embodiment.

[0117] Fig. 14E shows an embodiment which includes a cannula, or a needle, which includes balloon or expansion member 1408. In this embodiment, the balloon is inflated after the needle/cannula is in place in the reservoir. The larger OD of the balloon prevents the needle from slipping out of the port. One or more balloons may be present. The balloon may be inflated/deflated via a lumen in the cannula/needle. The balloon may be deflated before the cannula/needle is removed. Multiple balloons may utilize a single inflation lumen, or have multiple inflation lumens. [0118] Fig. 14F shows an embodiment similar to that shown in Fig. 14E, except that in this embodiment the balloon/expandable member is larger. In this embodiment the balloon, when inflated, fills up the majority of the reservoir. This reduces the volume of insulin in the system and allows for easier flushing and/or priming of the system. The balloons in the various embodiments may be made from a compliant or non-compliant material and may be incorporated into a needle or cannula. In the embodiment shown in Fig. 14F, the balloon is preferably made from a relatively non-compliant material so that the volume of the balloon can be better controlled.

[0119] In some embodiments, a balloon/expandable member may be used to flush the system of insulin. For example, a balloon similar to that shown in Fig. 14F may be inflated to displace virtually all of the volume of the reservoir, thus purging the reservoir of its contents. It may be deflated, completely, or only partially for insulin delivery.

[0120] Fig. 15A shows an embodiment where a balloon/expandable member is incorporated into the subcutaneous port reservoir instead of the cannula/needle.

[0121] Fig. 15B shows an embodiment which incorporates curved needle 1502. The curved needle is placed through the skin and into the subcutaneous port by holding the tip of the needle generally perpendicularly to the skin, and inserting the needle, angling as it is being inserted so that the needle is generally perpendicular to the skin during insertion. This involves angling the needle with respect to the surface of the skin as the needle is inserted. Once the needle is inserted, the curve of the tip of the needle helps prevent the needle from accidentally coming out of the subcutaneous port, as the needle will need to follow the same angles to be removed. To prevent the needle from accidentally moving to an angle allowing removal, stabilizer 1504 may be placed on the needle. The stabilizer may be incorporated into the adhesive patch component which holds the needle in place, or the stabilizer may be a separate component. The stabilizer prevents the needle from moving to an angle which will allow its removal. When the needle is to be removed on purpose, the stabilizer/patch may be removed. Fig. 15B shows an embodiment where curved needle 1502 includes at least two relatively straight portions, 1506 and 1508, although a curved needle may have one, or more than two straight portions. Also in this figure opening 1509 of the needle is facing away from the septum when the curved needle is in place, although it may face upward, or sideways. [0122] Different curve shapes and/or lengths may be used for people with different amounts of fat, or for different locations on the body. Also, different curve shapes and/or lengths may be used for subsequent punctures with one subcutaneous port to avoid puncturing in the same area of the septum.

[0123] Figs. 15C and 15D show an embodiment that includes shape memory needle 1510, such as a nitinol needle. The needle may be straight when it is at room temperature and take on a different shape, such as a curve, as shown here, or other shape, when the needle is exposed to body temperature. To remove the needle, either extra force or angling may be required, or alternatively, cold saline may be used to flush the system and straighten the needle.

[0124] Figs. 15E-G show an embodiment utilizing a locking needle. Needle 214 is pierced through the septum, and then locking needle 1512 is placed through the septum at a different angle to contact and engage needle 214, locking it in place in the reservoir. Locking needle 1512 is preferably small, and solid, not hollow, and may be bent so that it may be flattened, as shown in Fig. 15G. To remove needle 214, locking needle 1512 is removed first, then needle 214 is removed.

[0125] Figs. 16A and B show an embodiment of a pierceable septum which includes mesh 1602 on the bottom (reservoir facing) side of the septum, and palpable points 1604 on the top (skin facing) side of the septum. The septum may be made out of silicone or other suitable material, and the mesh may be made out of metal, polymer or other suitable material. Points 1604 may be felt through the skin when the subcutaneous port is implanted.

[0126] Any of the embodiments disclosed herein may include one or more of the needle capture features disclosed herein and may include a mesh as part of the pierceable septum and/or the subcutaneous port.

[0127] Embodiments disclosed herein which include an access device or needle for percutaneous access to a subcutaneous port may be designed to be worn continuously, for example for several days, before the access device/needle needs to be replaced. For example, the access device/needle (which may be incorporated into a patch) may be designed to be in place for up to 7 days. For example, the access device/needle may be designed to be in place for 1-3 days. For example, the access device/needle may be designed to be in place for 1-7 days. For example, the access device/needle may be designed to be in place for up to 10 days. For example, the access device/needle may be designed to be in place for up to 20 days. For example, the access device/needle may be designed to be in place for more than 1 hour. For example, the access device/needle may be designed to be in place for more than 1 day. For example, the access device/needle may be designed to be in place for more than 2 days. For example, the access device/needle may be designed to be in place for more than 3 days. For example, the access device/needle may be designed to be in place for more than 4 days. For example, the access device/needle may be designed to be in place for more than 5 days. For example, the access device/needle may be designed to be in place for more than 7 days.

[0128] Embodiments disclosed herein which include external insulin pumps may alternatively incorporate an implantable insulin pump. An insulin designed for peritoneal delivery may be used in the insulin pump. Insulin pumps may include a basal insulin delivery rate as well as the ability to deliver bolus amounts of insulin. The boluses may be delivered manually, or automatically, and the bolus size may be based on measured glucose levels, or estimates based on food/carbohydrates consumed.

[0129] Basal infusion rates (ongoing, automatic) may range from 0 to 15 units/hour, where there are 100 units of insulin per milliliter (ml) of liquid, or 500 units of insulin per milliliter (ml) of liquid. Alternatively the basal infusion rates may range from 0 to 35 units/hour. Bolus infusion volumes may range from 0 to 25 units or alternatively may range from 0 to 50 units. [0130] Lumen patency of the insulin delivery systems may be tested by a pressure sensor in the insulin pump, or elsewhere in the system. A test injection of saline or other inert fluid may be used to test the fluid path between the insulin pump and the peritoneal cavity. The pressure within the lumen may be measured to determine whether a blockage is present. A saline injection may also be used following an insulin injection to force any stagnant insulin out of the reservoir of the subcutaneous port and into the peritoneal cavity. A one way valve may also be present within the infusion tubing, patch, needle, subcutaneous port or insulin delivery tubing to prevent backflow of fluids. Alternatively the valve may be mechanical, and triggered by a switch or other mechanism. The embodiments disclosed herein may be used for insulin delivery and glucose sensing. They may also be used for any type of drug or fluid delivery, and/or any type of analyte sensing, including sodium, potassium, chloride, bicarbonate, urea, creatinine, triglyceride, protein, albumin, hemoglobin, oxygen, ketones, LDL, HDL, cholesterol, etc.

[0131] In some embodiments, the subcutaneous port reservoir may have a dynamic volume. In other words, it may be designed to expand and/or contract. For example, it may be expanded for introduction of the needle into the reservoir and then contract after the needle is in place to decrease the volume of the reservoir.

[0132] In some embodiments, a foam, or lattice may be incorporated into the insulin reservoir, as shown in Fig. 17. Foam 1702 takes up the majority of the volume in the insulin reservoir, which allowing a large area for the needle. This reduces the volume of insulin in the entire system which allows for tighter control of dosing and also facilitates flushing of the system. The foam would allow insulin to be injected through the needle and into the reservoir and through the catheter and into the peritoneal cavity.

[0133] Figs. 18A-18C show various embodiments of the distal tip of peritoneal catheter 216. Fig. 18A shows an embodiment of the catheter with flared end 1804 and rounded tip 1808. Fig. 18B shows an embodiment of the catheter with trumpet end 1806 and rounded tip 1808. Fig. 18C shows an embodiment of the catheter with rounded tip 1808. The flared end and trumpet end may incorporate an ID at the end of the catheter which is larger than the ID of the rest of the length of the catheter, or it may incorporate an ID which is the same as the rest of the catheter, while the OD is larger than that of the rest of the catheter. These embodiments may help prevent encapsulation or clogging of the distal tip of the catheter after implantation, as well as reduce trauma to tissue and prevent insulin aggregation. For example, the ID of the flared or trumpet tip may be around 2X the ID of the rest of the catheter. Alternatively, the ID of the flared or trumpet tip may be around 1.5X-3X the ID of the rest of the catheter. Alternatively, the ID of the flared or trumpet tip may be around 1.5X-2X the ID of the rest of the catheter. Alternatively, the ID of the flared or trumpet tip may be around 2X-3X the ID of the rest of the catheter. Alternatively, the ID of the flared or trumpet tip may be around 1.5X-4X the ID of the rest of the catheter.

[0134] In some embodiments, the ID of the majority of the length of catheter is around 0.030 inches. In some embodiments, the ID of the flared or trumpeted tip portion of the catheter is around 0.060 inches. In some embodiments, the OD of the majority of the length of catheter is around 0.065 inches. In some embodiments, the catheter is made from a polymer, such as a polycarbonate-based polyurethane. In some embodiments, the catheter material has a durometer of about 83 A. in some embodiments, the catheter material is hydrophilic.

[0135] Figs. 19A and 19B show an embodiment of the skin patch which includes a “folding” needle. This embodiment allows for subjects with varying thicknesses of skin and/or fat between the skin surface and the subcutaneous port. Thickness 1908 represents the fat portion, which may vary significantly among thinner and heavier subjects. In this embodiment, needle 1902 is initially straight, as shown in Fig. 19A, and is inserted into the subcutaneous port while it is still straight. After the needle is within the reservoir of the subcutaneous port, it is folded, as shown in Fig. 19B. The folding of the needle allows for a custom distance between the skin surface and the reservoir of the subcutaneous port, as well as allowing the needle to lay flat against the surface of the skin of the subject. The inner lumen of the needle remains open in the folded state. To aid in a smooth folding, and maintaining the inner lumen of the needle, features such as bar, or fulcrum, 1906 may be included in patch 1904 to prevent kinking of the needle as it is folded down to the skin surface. The patch may include different features to prevent kinking. The needle itself may have a length which is chemically and/or heat treated to make it more malleable and less susceptible to kinking when it is bent. The needle may be made of metal or polymer or any other suitable material or combination of materials. In some embodiments, a sheath or cannula may be folded rather than the needle itself, which may be removed.

[0136] Fig. 19B shows the needle “folding” in one location, however, the needle may be designed to fold in more than one location, for example, the needle may additionally or alternatively have one or more folds, or bends, within the reservoir.

[0137] In some embodiments, needles of different lengths may be offered to accommodate different ranges of subjects with different fat and/or skin thicknesses.

[0138] Embodiments disclosed herein are able to accommodate a variety of skin/fat depths, while providing ongoing, long term, minimal invasive access to the peritoneal cavity. Because the port is subcutaneous, infection risk and discomfort are minimal. The skin patch/external needle portion is designed to lay relatively flat, and be covered by an adhesive patch to minimize disruption. The accommodation of different skin fat depths may be achieved by a “folding” needle, different needle lengths, an angled needle access approach (where the needle is entered at different angles depending on the skin/fat thickness), etc. In some embodiments, this flexibility is provided by the skin patch/needle. In some embodiments this flexibility is provided by the subcutaneous port, for example, via flexible reservoir designs or the ability to secure the port closer and consistently near the skin surface. In some embodiments, this flexibility is provided by a combination of both the skin patch/needle and the subcutaneous port design.

[0139] Fig. 20 shows an embodiment of the subcutaneous port which includes hydrophilic layer 2002. Septum 302 may be manufactured from silicone. Silicone can react with insulin. Layer 2002 separates the septum from reservoir 218 which contains insulin. Layer 2002 may be a coating or a thin layer of a hydrophilic material, such as PTFE. To prevent detachment of later 2002 from septum 302, an etching process may be used before bonding the later to the septum. In addition, the structure of the subcutaneous port may encapsulate outer edge 2004 of layer 2002 to prevent del ami nation. [0140] In some embodiments, one or more component of the system is made from platinum cured high purity silicone. With this method, a platinum-based catalyst may be included in the silicone formulation to activate crosslinking. Depending upon the final application, the silicone can cure to be relatively flexible or very hard or in between. Platinum-catalyzed, addition cure chemistry is frequently chosen for implanted medical devices because there are no catalyzation byproducts; all formulation components are chemically bonded in the polymer matrix. Another benefit is the platinum catalyzation allows for flexibility in controlling the cure rate over a wide range of time and temperature.

[0141] In some embodiments, other components are either composed of hydrophilic materials or coated with hydrophilic materials and/or coatings. For example, the reservoir of the subcutaneous port may include a hydrophilic inner surface.

[0142] Figs. 21A-21D show various views of an embodiment of the subcutaneous port. Fig. 21A is a side view of the port, and shows septum 302 as well as catheter port 2104. Fig. 21B shows a cutaway side view of the same port, including septum 302, hydrophilic layer 2002, reservoir 218, catheter port 2104 and reservoir tapered region 2102. Fig. 21C shows a top view of the port, including septum 302 and catheter port 2104. Note that the septum may be elongated. Fig. 21D shows a cutaway top view at plane 21D shown in Fig. 21A. Shown here is reservoir 218 as well as reservoir tapered portion 2102 and catheter port 2104. In some embodiments, the reservoir has minimal “comers” or angled transitions. Here, the reservoir is shown as a smooth oval. In some embodiments, some, or all, of the edges within the reservoir are rounded to prevent the adherence of bubbles or fluid aggregation.

[0143] Fig. 22A shows an embodiment of the patch portion of the device which accounts for movement between the skin and the subcutaneous port. The actual adhesive skin patch is not shown here, but would cover patch body 2202, or could be between patch body 2202 and skin surface 2208. The patch body may also be referred to as an infusion set or infusion set housing herein. Patch body 2202 includes internal opening 2204 which contains bobble 2206, which contains, or secures, needle 214. Bobble 2206 is able to rotate within internal opening 2204 of the patch body when the patch is in place against skin surface 2208. The skin surface may move independently of the subcutaneous port, and this design allows the skin patch to move with the skin surface without significantly moving the needle within the septum of the subcutaneous port. The needle and the bobble stay essentially stationary, while patch body 2202 moves slightly with the skin. Bobble 2206 moves slightly with respect to patch body 2202 allowing for some flexibility in the system. The adhesive patch which covers the patch body may have an opening to accommodate, or otherwise allows for, movement of the needle with respect to the patch body. For insertion, it is preferred that the needle not move with respect to the patch body, and for this purpose, an insertion tool, or actuator, which holds the needle and patch body in place, may be used when the needle is first inserted into the septum of the subcutaneous port. The terms bobble, roller ball and tracker ball may be used interchangeably herein.

[0144] Fig. 22B shows some of the possible degrees of freedom between the infusion set and the subcutaneous port provided by embodiments disclosed herein. Twelve degrees of freedom are shown. The embodiment shown in Fig 22A may provide degrees 7, 8, 9, 10, and possibly degrees 11 and 12.

[0145] In any of the embodiments shown herein, the degrees of freedom provided may include those between the degrees of freedom stated. For example, here, where degrees 7, 8, 9 and 10 are stated, the range of degrees between these is also provided, for example, rotation in any direction (360 degrees) is provided in this embodiment.

[0146] Fig. 23 shows insertion tool or actuator housing 2302 which stabilizes the needle portion of the body patch shown in Fig. 22A for the purposes of needle insertion through the skin and through the septum of the subcutaneous port.

[0147] Fig. 24 shows an embodiment of an actuator/infusion set combination which performs several functions. These functions include:

[0148] - actuator: needle safety

[0149] - actuator: needle stabilization during insertion through skin and into subcutaneous port

[0150] - actuator: needle bending to accommodate different distances between the infusion set and the subcutaneous port

[0151] - infusion set: needle movement between the infusion set and the subcutaneous port in several degrees of freedom

[0152] Shown here are actuator housing 2402, actuator roller 2404, actuator plunger 2406, actuator safety 2408, actuator button 2410, infusion set needle roller ball 2412 and infusion set needle 2414.

[0153] Figs. 25A and 25B show the actuator portion of the combination shown in Fig. 24. Shown here are actuator housing 2402, actuator roller 2404, actuator plunger 2406, actuator safety 2408, actuator button 2410, and actuator fulcrum 2502. [0154] Figs 26 A-C show the infusion set portion of the combination shown in Fig. 24. Shown here are infusion set needle 2414, infusion set needle roller ball 2412, including needle roller ball semi-spherical surface 2608 and needle roller ball flat surface 2510, infusion set housing 2602, infusion set slide 2606 and infusion set cap 2604.

[0155] Figs. 27A-B show the needle insertion process using the actuator and the infusion set. First, the actuator, containing the infusion set, is placed against skin 2702. At this step, safety 2408 is engaged with shaft 2704 of the actuator to prevent needle 2414 from extending beyond infusion set housing 2602. Safety 2408 engages with shaft 2704 so that needle roller ball 2412 cannot advance and therefore cannot extend beyond the infusion set housing. Freedom directions 1, 2, 3, 4, 5, 6 are, at this point, constrained. The sharp needle tip is protected by the infusion set housing. Flat section 2510 of the needle ball rests against a flat section of plunger 2406 so that needle 2414 also cannot move in freedom degrees 7, 8, 9, or 10 during insertion. Freedom directions 11 and 12 may also be constrained by the system. [0156] To insert the needle into the subcutaneous port (not shown), safety 2408 is removed from shaft 1704. This removes the constraint on freedom direction 6 (down), and using plunger 2406, the user may insert the needle through skin 2702 and through the septum of the subcutaneous port until the needle is in the reservoir of the subcutaneous port. The needle may reach the bottom of the reservoir of the subcutaneous port, which may provide tactile feedback that the needle is in place in the reservoir of the port. This is shown in Fig. 27B. Slide 2606 may be in the extended position, as shown here, during the insertion step. Alternatively, the slide may be placed into the extended position after insertion, but before the next step. The position of slide 2606 is controlled by button 2410.

[0157] Figs. 28A and 28B show the needle bending step, which creates custom needle lengths, which accommodates different skin/fat thicknesses, and different distances between the infusion set and the subcutaneous port. The needle may be bent at any location along the needle, creating different needle lengths. By different needle lengths, it is meant different lengths of needle extending below the skin surface. To do this, one the needle is in the reservoir of the subcutaneous port, the needle is bent, so that it will subsequently lay relatively flat against the user’s skin. Depending on the material of the needle, the needle may need to be bent past the desired final angle, since there may be some spring back in the needle. For example, the needle may be bent to around 54 degrees, so that it will spring back to approximately 90 degrees. [0158] The needle is bent using actuator roller 2404. Fig. 28A shows the use of roller 2404 to force needle 1414 over fulcrum 2502. The roller rotates around an axis and may be moved manually or automatically. In some embodiments, it may be moved by the movement of the plunger during insertion. Fig. 28A shows the needle in an overbent position, where angle 2802 is less than the final desired angle. For example, angle 2802 may be around 54 or 55 degrees.

[0159] Fig. 28B shows roller 2404 returned to a position where it is no longer applying a force to the needle. As a result, the needle may spring back to angle 2804 which is greater than angle 2802. For example, angle 2804 may be approximately 90 degrees. Note that during this process, slide 2606 is in the extended position, so that it is not in the way of the bending or spring back of needle 2414.

[0160] Figs. 29A-C show needle 2414 being placed in position for compliance - i.e. placed in position to support several degrees of freedom to support movement of the infusion set on the skin relative to the subcutaneous port. Fig. 29A shows the system after the needle has been bent, and allowed to spring back, similar to the stage depicted in Fig. 28B. Fig. 29B shows slide 2606, moved via button 2410, as it is being slid into place under needle roller ball 2412. Slide 2606 may snap into place within the in the infusion set housing when it is engaged. Slide 2606 may be slid into place as roller 2404 is rotated back to its starting position. Slide 2606 has tracks on which the roller ball can slide and rotate. The needle roller ball may slide back and forth as shown by arrows 2902 as well as rotate in any direction. This compliance will allow the infusion set attached to the skin to move relative to the subcutaneous port, without breaking the needle or fatiguing the materials of the system.

[0161] Fig. 29C shows how slide 2606 moves fulcrum 2502 out of the way as slide 2606 is slid into place under the roller ball, using button 2410. Fulcrum 2502 provides support to the needle during bending, however it may be removed with the actuator so that there is adequate clearance around the needle so that the needle has space to move and rotate. Slide angled portion 2906 pushes against fulcrum angled portion 2904 when slide is engaged which forces fulcrum 2502 in the direction shown by arrow 2908. The final position of Fulcrum 2502 is contained within the actuator such that when the actuator is removed, the fulcrum is removed. [0162] Fig. 29D shows the infusion set after the needle has been inserted and bent, and the actuator has been removed. The next step is to place the infusion set cap over the rest of the infusion set.

[0163] Fig. 29E shows the infusion set with infusion set cap 2604 in place. [0164] Figs. 30A-C show detail of the infusion set. Fig. 30A shows opening 3002 in housing 2602 allows for freedom of movement of needle 2414. Fig. 30B shows rails 3008 and indent 3009 in housing 2602 which allow for transverse (directions 3006) and rotational movement (directions 3004) of needle roller ball 2412 when the infusion set is in place. Fig. 30C shows infusion set cap 2604 as well as indent 3010 and rails 3012 which provide the upper enclosure for needle roller ball 2412 once the cap is in place on top of the infusion set housing. Housing 2602 and cap 2604 encapsulate needle roller ball 2412 within, while allowing the roller ball to rotate and move transversely within the infusion set. This allows for several degrees of freedom of the needle. These degrees of freedom include 1, 2, 7, 8, 9 and 10.

[0165] Figs. 31A-C show other possible designs which provide needle compliance, or degrees of freedom of movement. Fig. 31A shows a design which allows for transverse needle movement in any direction. Needle cap piece 3102 is relatively flat and is free to slide within cavity 3104 of the infusion set housing. Opening 3106 is large enough, and preferable round, but may be of any shape, so that the needle can move freely in any transverse direction. The degrees of freedom include degrees 1, 2, 3, 4 and possibly degrees 11 and 12. [0166] Fig. 3 IB shows a design with a flexible needle. Needle 3112 is attached to infusion tubing 3114. The needle is folded similar to methods disclosed herein. The bend of folded needle 3112 resides within open cavity 3115 of the infusion set housing, allowing it flexibility to move in several directions. The needle is made from a material and or dimensions that allows it to flex somewhat within the cavity. Opening 3110 on the bottom of the infusion set housing further allows movement of needle 3112. Degrees of freedom include degrees 7, 8, 9, 10 and possibly degrees 1, 2, 5 and 6.

[0167] Fig. 31C shows a design with flexible tubing. This design may or may not also include a flexible needle as depicted in Fig. 3 IB. Needle 3120 is connected to infusion tubing 3118. The infusion tubing material and/or dimensions that allow it some flexibility in several directions within infusion set housing cavity 3117. Opening 3116 on the bottom of the infusion set housing further allows movement of needle 3120, which is connected to tubing 3118. Degrees of freedom include degrees 3, 4, 7, 8, 9, 10 and possibly degrees 1, 2, 5 and 6).

[0168] Some embodiments disclosed herein may allow for needle motion between the infusion set and the subcutaneous port by allowing the following degrees of freedom: degrees 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12; degrees 1, 2; degrees 3, 4; degrees 5, 6; degrees 7, 8; degrees 9, 10; degrees 11, 12, and any other combination of degrees 1-12. [0169] Figs. 32A-E show the insertion process of the design with a flexible needle, as shown in Fig. 3 IB. Fig. 32A shows actuator housing 2402, roller 2404, plunger 2406, fulcrum 2502, needle 3201 and flexible needle cap 3202 after needle insertion.

[0170] Fig. 32B shows the bending of needle 3201 over fulcrum 2502 using roller 2404 to force the needle over the fulcrum. The needle is shown overbent here, and will spring back to approximately 90 degrees.

[0171] Fig. 32C shows the infusion set after the actuator has been removed. This figure shows two different needle bending options - these are shown by combination needle cap 3202 and needle 3201 and by combination needle cap 3202’ and needle 3201’. These two different options represent needle folding to accommodate two different distances between the infusion set and the subcutaneous port. Other distances may also be achieved. Flexible needle slide 3204 is also shown, in the extended position.

[0172] Fig. 32D shows the infusion set of this embodiment where slide 3204 has been inserted into the infusion set housing. Slide 3204 may include tracks for needle cap 3202 to slide upon transversely. Fig. 32D also shows infusion set cap 3206 in place. In this embodiment, when infusion set cap 3206 is in place, slide 3204 and cap 3206 rigidly constrain needle cap 3202.

[0173] Fig. 32E shows infusion set cavity 3208 and opening 3110 which allows needle 3201 to move freely within the infusion set. The flexibility of the needle may be due to the flexibility inherent in the bend of the needle, the material of the needle or both.

[0174] Figs. 33A-E show the insertion process of the design with flexible tubing as shown in Fig. 31C. Fig. 33A shows actuator housing 2402, roller 2404, plunger 2406, fulcrum 2502, needle 3301 and needle cap 3302 after needle insertion.

[0175] Fig. 33B shows the bending of needle 3301 over fulcrum 2502 using roller 2404 to force the needle over the fulcrum. The needle is shown overbent here, and will bounce back to approximately 90 degrees.

[0176] Fig. 33C shows the infusion set after the actuator has been removed. This figure and Fig. 33D show two different needle bending options - these are shown by combination needle cap 3302 and needle 3301 and by combination needle cap 3302’ and needle 330F. These two different options represent needle folding to accommodate two different distances between the infusion set and the subcutaneous port. Other distances may also be achieved. Flexible needle slide 3304 is also shown, in the engaged position. Slide 3304 may include tracks for needle cap 3302 to slide upon transversely. Needle tubing 3310 is held rigidly between slide 3304 and cap 3312 with a segment of needle tubing 3310 adjacent to needle cap 3302 that is free to flex in directions 3, 4, 5, 6, 7, 8, 9, and 10. This segment of needle tubing 3310 is proximal to (further from the patient skin) than needle cap 3302.

[0177] Fig. 33D and 33E also show infusion set cavity 3308 and opening 3116 which allows needle 3301 to move freely within the infusion set. The flexibility in this embodiment is primarily driven by the flexibility of infusion tubing 3310. The junction of needle 3301 and infusion tubing 3310 sits within cavity 3308, allowing the flexibility of the infusion tubing to allow movement of the connected needle within cavity 3308 and opening 3116. Fig. 33E is shown without cap 3312. Also shown in Fig. 33E are hard stops 3314 which limit the longitudinal range of motion of the needle and infusion tubing within the infusion set. [0178] Figs. 34A-F show the insertion process of the design with a bobble or tracker ball as shown in Figs. 22A and 23. Fig. 34A shows actuator housing 2402, roller 2404, plunger 2406, needle 3401, needle cap 3402 and bobble clamshell 3404 after needle insertion. [0179] Fig. 34B shows another perspective of the embodiment shown in Fig. 34A. Also clearly shown here is opening 3101, which allows free needle movement once the infusion set is in place. Roller 2404 is used to bend needle 3401 over the fulcrum similar to other embodiments disclosed herein, bending needle 3401 at its desired length to accommodate skin/fat thickness. Overbending may not be necessary in this embodiment. Stabilizer 3405 holds clamshell 3404 in place, preventing movement or rotation, during needle insertion and during needle bending. After the needle bending, stabilizer 3405 may be removed by squeezing levers 3412, subsequently allowing needle freedom of movement.

[0180] Fig. 34C shows bobble clamshell 3404 in the open position. The clamshell includes upper arm 3406, lower arm 3408 and bobble portion 2206.

[0181] Fig. 34D shows clamshell 3404 in the closed position, after bending the needle. [0182] Fig. 34E shows a top view of the actuator and infusion set, including actuator housing 2402, roller 2404 and bobble clamshell 3404.

[0183] Fig. 34F shows the infusion set in place, including cap 3410 which encapsulates bobble 2206 within the housing of the infusion set. Needle 3401 is free to move within opening 3101.

[0184] Figs. 35A through 35D shown embodiments of the subcutaneous port which include tissue in-growth areas. Fig. 35A shows subcutaneous port 106 with tissue in-growth areas 3504 and 3506. Also shown are palpable points 3502. Tissue in-growth may be desirable to secure the subcutaneous port in position once implanted. Stabilizing the subcutaneous port helps prevent scar tissue, tissue irritation and port migration. Shown here are top in-growth areas and bottom in-growth areas, but in-growth material may be placed anywhere on the port or the implantable portion of the system.

[0185] In some embodiments, in-growth material may be used to anchor tissue to the subcutaneous port (as opposed to, or in addition to, anchoring the subcutaneous port to tissue). For example, the subcutaneous port may be sutured to tissue or bone or anchored to tissue or bone via other mechanisms, including tissue in-growth. It is also desirable to minimize tissue movement around the subcutaneous port, even in embodiments which include the ability of the needle to move within the infusion set to accommodate skin movement. In-growth material on the top of, and/or sides of, and/or elsewhere on, the subcutaneous port may help reduce the movement of surrounding tissue, reducing movement of the infusion set with respect to the subcutaneous port.

[0186] Fig. 35A shows in-growth area around the outer edges of the circumference of the top of the subcutaneous port, as well as on the bottom of the port.

[0187] Fig. 35B shows in-growth area 3508 around the outer edges of the top surface of the subcutaneous port, as well as on the bottom of the port.

[0188] Fig. 35C shows in-growth area 3510 around the outer edges of the top surface of the subcutaneous port, as well as in-growth area 3512 at least partially around, and flush with the outer surface of, the sides of the port. The in-growth area may alternatively be recessed within, or extend outside, the outer surface of the sides of the port.

[0189] Fig. 35D shows in-growth area 3514 at least partially around, and flush with the outer surface of, the sides of the port. The in-growth area may alternatively be recessed within, or extend outside, the outer surface of the sides of the port.

[0190] In-growth areas may be in one location, like the top or bottom of the port, or in more than one location. In-growth materials may be any material which supports tissue in-growth, including Dacron, hydroxyapatite coating, titanium sputter coating, other porous coatings, including 3D printed coatings and/or ports, including 3D printed titanium etc. For example, a porous coating may result in a coating with 700 pm pores and 300 pm stmts or a coating with 300-400 pm pores.

Since the patch or infusion set is replaceable, a “docking” or matching system may be useful to align the needle of the patch with the septum of the subcutaneous port so that when a new patch is applied to the skin, the needle of the patch is sure to pierce the septum of the port and enter the reservoir of the port. The docking system may include magnetics, so that the patch is automatically centered or aligned with the subcutaneous port before the needle is deployed into the port. Alternative or additionally, bumps, or ridges or other tactile features may be included on the skin-facing side of the port so that they may be felt through the skin to aid in alignment.

[0191] Figs. 36A-D show a guide which may be used to help align the infusion set with the subcutaneous port. Since the subcutaneous port is below the skin, one may need to rely on feeling the port, or palpable points on the port, to identify the location of the port. Even so, because the septum of the port may be small, it may be beneficial to be able to precisely align the needle with the septum for insertion. Fig. 36A shows an aligner which is placed over the skin covering the subcutaneous port which engages with the actuator to align the needle with the septum of the subcutaneous port for needle insertion. Shown here is aligner 3602 with flexible arms 3604 and alignment pins 3606. The arms may include grips and/or ridges on the top and/or bottom, for extra grip. The arms and/or device in general, may be flexible enough to contact the skin over a subcutaneous port, and squeeze the skin somewhat while maintaining contact with the skin.

[0192] Fig. 36B shows how the geometry of aligner 3602 may fit with the geometry of the surface of subcutaneous port 106, so that one can precisely position the aligner with respect to the subcutaneous port, even through skin.

[0193] Fig. 36C shows how pins 3606 of aligner 3602 may engage with openings 3608 in actuator housing 2402. This allows the actuator to become aligned with the aligner, and ultimate aligned with the septum of the subcutaneous port.

[0194] Fig. 36D shows the aligner in use being aligned, through the skin, with points on the subcutaneous port. The flexibility of the aligner help accommodate different fat/skin thicknesses. The grips and/or material of the aligner help the user maintain grip with the patient’s skin, as well as the user’s hands, during use, sometimes in wet conditions.

[0195] Some embodiments of the aligner/actuator may accommodate subsequent needle insertions at slightly different locations within the septum of the subcutaneous port. This may be achieved by multiple openings or multiple pins, or by movable pins. In embodiments that accommodate different skin fat thicknesses between the infusion set and the subcutaneous port, the distance between the skin surface and the top of the port/septum may be able to range from around 0.5-2.0 cm. Alternatively, the distance between the skin and top of the port/septum may be able to range from around 0.5-3.0 cm. Alternatively, the distance between the skin and top of the port/septum may be able to range from around 0.5-4.0 cm. Alternatively, the distance between the skin and top of the port/septum may be able to range from around 1.0-2.0 cm. Alternatively, the distance between the skin and the top of the port/septum may be able to range from around 1.0-3.0 cm. Alternatively, the distance between the skin and the top of the port/septum may be able to range from around 1.0-4.0 cm. Alternatively, the distance between the skin and the top of the port/septum may be able to range from around 1.0-5.0 cm.

[0196] In some embodiments, the needle and/or other components of the system may be coated with an antimicrobial coating. For example, the needle may be coated with copper and/or silver, including the ID and/or the OD of the needle.

[0197] Embodiments disclosed herein may include an infusion set or patch which sits relatively flat or flush to the skin. For example, the infusion set may not protrude more than 1/8”, or the infusion set may not protrude more than 1/4”, or the infusion set may not protrude more than 1/2”, or the infusion set may not protrude more than 3/4”.

[0198] Embodiments disclosed herein which include infusion sets with needle compliance, i.e., the ability of the needle to move with respect to, or accommodate, skin movement, may accommodate skin movement of around 0.25”. Alternatively, they may accommodate skin movement of around 0.5”. Alternatively, they may accommodate skin movement of around 0.75”. Alternatively, they may accommodate skin movement of around 1.0”

[0199] Example of Data Processing System

[0200] FIG. 37 is a block diagram of a data processing system, which may be used with any embodiment of the invention. For example, the system 3700 may be used as part of the controller component of system. Note that while FIG. 37 illustrates various components of a computer system, it is not intended to represent any particular architecture or manner of interconnecting the components; as such details are not germane to the present invention. It will also be appreciated that network computers, handheld computers, mobile devices, tablets, cell phones and other data processing systems which have fewer components or perhaps more components may also be used with the present invention.

[0201] As shown in FIG. 37, the computer system 3700, which is a form of a data processing system, includes a bus or interconnect 3702 which is coupled to one or more microprocessors 3703 and a ROM 3707, a volatile RAM 3705, and a non-volatile memory 3706. The microprocessor 3703 is coupled to cache memory 3704. The bus 3702 interconnects these various components together and also interconnects these components 3703, 3707, 3705, and 3706 to a display controller and display device 3708, as well as to input/output (I/O) devices 3710, which may be mice, keyboards, modems, network interfaces, printers, and other devices which are well-known in the art.

[0202] Typically, the input/output devices 3710 are coupled to the system through input/output controllers 3709. The volatile RAM 3705 is typically implemented as dynamic RAM (DRAM) which requires power continuously in order to refresh or maintain the data in the memory. The non-volatile memory 3706 is typically a magnetic hard drive, a magnetic optical drive, an optical drive, or a DVD RAM or other type of memory system which maintains data even after power is removed from the system. Typically, the non volatile memory will also be a random access memory, although this is not required.

[0203] While FIG. 37 shows that the non-volatile memory is a local device coupled directly to the rest of the components in the data processing system, the present invention may utilize a non-volatile memory which is remote from the system; such as, a network storage device which is coupled to the data processing system through a network interface such as a modem or Ethernet interface. The bus 3702 may include one or more buses connected to each other through various bridges, controllers, and/or adapters, as is well- known in the art. In one embodiment, the I/O controller 3709 includes a USB (Universal Serial Bus) adapter for controlling USB peripherals. Alternatively, I/O controller 3709 may include IEEE- 1394 adapter, also known as FireWire adapter, for controlling FireWire devices, SPI (serial peripheral interface), I2C (inter-integrated circuit) or UART (universal asynchronous receiver/transmitter), or any other suitable technology.

[0204] Some portions of the preceding detailed descriptions have been presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the ways used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self- consistent sequence of operations leading to a desired result. The operations are those requiring physical manipulations of physical quantities.

[0205] It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise as apparent from the above discussion, it is appreciated that throughout the description, discussions utilizing terms such as those set forth in the claims below, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.

[0206] The techniques shown in the figures can be implemented using code and data stored and executed on one or more electronic devices. Such electronic devices store and communicate (internally and/or with other electronic devices over a network) code and data using computer-readable media, such as non-transitory computer-readable storage media (e.g., magnetic disks; optical disks; random access memory; read only memory; flash memory devices; phase-change memory) and transitory computer-readable transmission media (e.g., electrical, optical, acoustical or other form of propagated signals — such as carrier waves, infrared signals, digital signals).

[0207] The processes or methods depicted in the preceding figures may be performed by processing logic that comprises hardware (e.g. circuitry, dedicated logic, etc.), firmware, software (e.g., embodied on a non-transitory computer readable medium), or a combination of both. Although the processes or methods are described above in terms of some sequential operations, it should be appreciated that some of the operations described may be performed in a different order. Moreover, some operations may be performed in parallel rather than sequentially.

Claims

CLAIMS What is claimed is:

1. An infusion assembly, comprising: a needle having an insertion portion and defining a lumen therethrough; an infusion set housing having a channel defined at least partially through the infusion set housing between a first opening defined along a peripheral portion of the infusion set housing and a second opening defined along a securement surface where the infusion set housing is securable to a skin surface of a subject along the securement surface; an actuator roller removably positioned in proximity to the second opening of the infusion set housing and contacted against the needle, whereby actuation of the actuator roller imparts a curvature along the needle proximally of the insertion portion such that a proximal portion of the needle is positionable through the channel, and wherein a length of the insertion portion of the needle is adjustable relative to the second opening to accommodate a variable insertion depth of tissue underlying the second opening when the securement surface is secured to the skin surface.

2. The assembly of claim 1 further comprising a port configured for subcutaneous implantation within the subject, wherein the port defines a reservoir configured to receive the insertion portion of the needle.

3. The assembly of claim 2 wherein the port includes at least one area configured for tissue in-growth.

4. The assembly of claim 3 wherein the at least one area is positioned along a side or top portion of the port.

5. The assembly of claim 2 further comprising a catheter fluidly coupled to the reservoir, wherein the catheter is configured to be implanted within the subject.

6. The assembly of claim 1 further comprising an infusion reservoir fluidly coupled to the lumen of the needle.

7. The assembly of claim 6 further comprising a volume of insulin contained within the infusion reservoir.

8. The assembly of claim 1 wherein the length of the insertion portion of the needle is adjustable via re-positioning of a location of the curvature along the needle.

9. The assembly of claim 1 wherein the needle is movably positioned within the channel such that the infusion set housing accommodates a movement of the needle relative to the infusion set housing when the securement surface is secured to the skin surface

10. A method of adjustably inserting a needle, comprising: positioning a securement surface of an infusion set housing along a skin surface of a subject, the infusion set housing defining a channel at least partially through the infusion set housing between a first opening defined along a peripheral portion of the infusion set housing and a second opening defined along the securement surface; advancing an insertion portion of a needle to a predetermined depth beyond the skin surface; adjusting a length of the insertion portion relative to the second opening to accommodate a variable insertion depth of tissue underlying the second opening; and imparting a curvature along the needle proximally of the insertion portion such that a proximal portion of the needle is positionable through the channel.

11. The method of claim 10 wherein advancing the insertion portion of the needle comprises advancing the insertion portion into a reservoir contained within a port implanted subcutaneously within the subject.

12. The method of claim 11 wherein the port includes at least one area configured for tissue in-growth.

13. The method of claim 12 wherein the at least one area is positioned along a side or top portion of the port.

14. The method of claim 11 further comprising introducing a fluid into the reservoir via the needle such that the fluid is infused within a peritoneal cavity of the subject via a catheter fluidly coupled to the port.

15. The method of claim 14 wherein infusing the fluid within the peritoneal cavity comprises infusing a volume of insulin.

16. The method of claim 10 wherein the needle is movably positioned within the channel such that the infusion set housing accommodates a movement of the needle relative to infusion set housing when the securement surface is secured to the skin surface.

17. An infusion assembly, comprising: a needle having an insertion portion and a curved portion and defining a lumen therethrough; an infusion set housing having a channel defined at least partially through the infusion set housing between a first opening defined along a peripheral portion of the infusion set housing and a second opening defined along a securement surface of the housing where the infusion set housing is securable to a skin surface of a subject along the securement surface; and a needle roller ball movably positioned within the channel and connected to a proximal end of the needle as the insertion portion extends through the second opening, wherein the needle roller ball is configured to slide or rotate within the channel while remaining connected to the proximal end of the needle to accommodate a movement of the needle relative to the infusion set housing when the securement surface is secured to the skin surface.

18. The assembly of claim 13 further comprising a port configured for subcutaneous implantation within the subject, wherein the port defines a reservoir configured to receive the insertion portion of the needle.

19. The assembly of claim 18 wherein the port includes at least one area configured for tissue in-growth.

20. The assembly of claim 19 wherein the at least one area is positioned along a side or top portion of the port.

21. The assembly of claim 18 further comprising a catheter fluidly coupled to the reservoir, wherein the catheter is configured to be implanted within the subject.

22. The assembly of claim 17 further comprising an infusion set slide positioned within the infusion set along the channel and sized to accommodate the needle roller ball therealong.

23. The assembly of claim 17 further comprising an infusion set cap configured for securement over the infusion set housing.

24. The assembly of claim 17 further comprising an infusion reservoir fluidly coupled to the lumen of the needle.

25. The assembly of claim 24 further comprising a volume of insulin contained within the infusion reservoir.

26. The assembly of claim 17 wherein the needle roller ball allows at least two degrees of freedom of movement to the needle relative to the housing.

27. The assembly of claim 17 wherein a length of the insertion portion of the needle is adjustable relative to the second opening to accommodate a variable insertion depth of tissue underlying the second opening when the securement surface is secured to the skin surface.

28. A method of adjustably inserting a needle, comprising: positioning a securement surface of an infusion set housing along a skin surface of a subject, the infusion set housing defining a channel at least partially through the infusion set housing between a first opening defined along a peripheral portion of the infusion set housing and a second opening defined along the securement surface; advancing an insertion portion of a needle to a predetermined depth beyond the skin surface; and imparting a curvature along the needle proximally of the insertion portion such that a proximal portion of the needle is positionable through the channel, wherein the needle is configured to accommodate a movement of the needle relative to the infusion set housing when the securement surface is secured to the skin surface.

29. The method of claim 28 wherein advancing the insertion portion further comprises adjusting a length of the insertion portion relative to the second opening to accommodate a variable insertion depth of tissue underlying the second opening.

30. The method of claim 28 wherein advancing the insertion portion of the needle comprises advancing the insertion portion into a reservoir contained within a port implanted subcutaneously within the subject.

31. The method of claim 30 wherein the port includes at least one area configured for tissue in-growth.

32. The method of claim 31 wherein the at least one area is positioned along a side or top portion of the port.

33. The method of claim 30 further comprising introducing a fluid into the reservoir via the needle such that the fluid is infused within a peritoneal cavity of the subject via a catheter fluidly coupled to the port.

34. The method of claim 33 wherein infusing the fluid within the peritoneal cavity comprises infusing a volume of insulin.