Systems, methods, apparatus and devices for drug or substance delivery

Abstract

To provide a system, method, apparatus and device for suitable drug or substance delivery.SOLUTION: Embodiments of the present disclosure relate to small insulin patch pumps, assistive devices (e.g., for reservoir filling and / or cannulation), and methods related thereto. For example, in some embodiments, a substance / drug delivery patch pump is provided and includes a reusable part (RP) including a power source, a drive mechanism, and an electronics module, and a disposable part (DP), where the disposable part may include at least a plurality of an adhesive base, a reservoir, a dosing mechanism, and a cannula.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] Related Applications This disclosure claims the benefit of and priority to the following earlier disclosures: U.S. Provisional Application No. 62 / 551,082, filed August 28, 2017, entitled "Systems, Methods, and Devices for Drug Delivery," U.S. Provisional Application No. 62 / 572,887, filed October 16, 2017, entitled "Systems, Methods, and Devices for Drug Delivery," U.S. Provisional Application No. 62 / 599,493, filed December 15, 2017, entitled "Systems, Methods, and Devices for Drug Delivery," and International Application No. IL2018 / 050668, filed June 15, 2018, entitled "Patch Pump Systems and Apparatus for Managing Diabetes, and Methods thereof," each of which disclosures is incorporated herein by reference in its entirety.

[0002] Embodiments of the present disclosure relate to insulin (or other substance) dispensing pumps (eg, mini-pumps, or patch pumps) and devices to assist with at least one of reservoir filling and cannulation (for example). [Background technology]

[0003] Diabetic patients require varying amounts of insulin throughout the day to control their blood glucose levels. Portable, ambulatory insulin infusion pumps can serve as an excellent alternative to multiple daily syringe insulin injections. However, while these devices represent an improvement over multiple daily injections, they nonetheless suffer from several drawbacks. One drawback is the large size and weight of the devices, resulting from the drive mechanism and syringe configuration and relatively large size. These relatively bulky devices must be regularly carried in the patient's pocket or attached to their belt. Cannulation for transdermal delivery of insulin (and / or other substances) and pump reservoir filling are not adequately addressed by current systems and devices. Summary of the Invention [Means for solving the problem]

[0004] Embodiments of the present disclosure relate to miniature insulin patch pumps and assist devices for reservoir filling and cannulation. In the discussion of some embodiments in this disclosure, insulin will be referred to as the drug being delivered by the patch pumps disclosed herein, but it will be understood that use of the disclosed patch pumps with other fluids is within the scope of the inventive embodiments described herein.

[0005] In some embodiments of the present disclosure, a drug delivery system is provided that includes at least two or more, and in some embodiments, all, of a drug delivery patch pump, an assist device configured for at least one of reservoir filling and cannulation, and optionally a gateway device.

[0006] Such embodiments may include one or more (and in some embodiments, more than one, and in some embodiments, all) of the following additional features, functions, structures, and / or clarifications, which may (in some cases) result in further embodiments: The gateway device may be a smartphone. The gateway device may be configured to enable communication to and / or from the pump to one or more of the at least one server and the charger and support device. The assist device may include at least one of a reservoir filling mechanism, a cannulation mechanism, and a DR-RP alignment mechanism.

[0007] In some embodiments, a substance / drug delivery patch pump is provided and includes a reusable part (RP) including a power source, a drive mechanism, and an electronics module, and a disposable part (DP), wherein the disposable part (DP) can include at least a plurality of adhesive bases, reservoirs, administration mechanisms, and cannulas.

[0008] In some embodiments, an assist device configured for use with a drug delivery pump (e.g., a patch pump) is provided. Such embodiments may include a housing that includes at least one of a reservoir filling mechanism, a cannulation mechanism, and / or a disposable part (DP), reusable part (RP) alignment mechanism.

[0009] Such embodiments may include one or more (and in some embodiments, more than one, and in some embodiments, all) of the following additional features, functions, structures, and / or clarifications, which may (in some cases) result in further embodiments: The device may be configured for pre-assembly with disposable components of a drug delivery patch pump. - one or more notches configured for insertion of a reusable part (RP) of the drug delivery patch pump and for alignment of the RP and the disposable part (DP) of the drug delivery patch. The reservoir filling mechanism resides in the first housing, and the cannulation mechanism and DR-RP alignment mechanism reside in the second housing. A reservoir filling mechanism may be configured to provide delivery of insulin (and / or other drugs or substances) from an insulin vial to a reservoir of the patch pump. - The device may be configured so that a vial is connected to the device and delivers a set amount / quantity (eg 50 units) of drug from the vial to the reservoir. - Drug delivery (delivery to the reservoir) can be achieved by pressing and releasing the vial once. - Successive vial presses deliver multiple insulin quantities. - the rotary and / or linear means are configured to set the amount of drug delivered from the vial. The reservoir filling mechanism may include a cavity having an exchangeable volume such that when the cavity volume increases, medicament can be delivered from the vial to the cavity via the filling needle, and when the cavity volume decreases, medicament can be delivered from the cavity to the reservoir via the delivery needle. The reservoir filling mechanism may include at least one, preferably a plurality, and more preferably all of: a cylindrical filling sleeve having top and bottom caps and top and bottom openings; a filling piston configured for linear displacement within the filling sleeve; and a sliding rod that traverses the top opening of the filling sleeve. o A sliding rod may be connected to the filling piston on one side and to the vial adapter on the other side. An internal space may be formed between the filling piston and the top of the filling sleeve. - One or more gaskets are configured to hermetically seal components of the reservoir filling mechanism. - the reservoir filling mechanism may include at least one, and preferably a plurality, and more preferably all, of a vial adapter, a filling needle having a sharp tip present within the vial adapter, the filling needle configured to traverse the sliding rod and providing hydraulic communication between the filling needle tip and the cavity. The reservoir filling mechanism may include a first one-way valve configured to provide one-way fluid delivery through the filling needle and / or a second one-way valve that may be configured to provide one-way fluid delivery through the delivery needle. The reservoir filling mechanism further includes a vent needle including a sharp tip that may be positioned within the vial adapter and traverse the sliding rod to provide pneumatic communication between the atmosphere and the vent needle tip. The reservoir filling mechanism may include a piston spring configured to compress and decompress when the piston is displaced (e.g., downward, upward, one way, and the other way). The reservoir filling mechanism may include at least one needle protector. At least one of the needle protectors may include a petal-like spring. o Petal-like springs may contain one or more bending leaflets. - Prior to connection of the vial to the vial adapter, the leaves of the needle protector are configured to be parallel to at least one of the fill needle and / or vent needle. The leaves are configured to curve over at least one needle to protect the user from inadvertently pricking themselves.

[0010] In some embodiments, a drug delivery system is provided that includes at least one of a cannulation mechanism and a reservoir filling mechanism. Such embodiments may (in some cases) include one or more (and in some embodiments, more than one, and in some embodiments, all) of the following additional features, functions, structures, and / or clarifications that may result in further embodiments: The reservoir filling mechanism may include a plurality of vial adapters, plungers, vent needles, fill needles, fill needle caps, and cylinders. o The filling needle and / or vent needle may be configured to traverse across the body of the plunger. The ends of the filling needle and / or vent needle protrude from one and / or the other tip of the plunger. o The first end of the plunger may be connected to a vial adapter. The first ends of the vent needle and the fill needle both protrude from the first end of the plunger into the interior of the vial adapter. The second end of the plunger may be configured to fit within the cylinder. o A seal may be included between the plunger and cylinder via a gasket. o The closed end of the cylinder may be constructed using a septum. o The filling and / or venting needle contains a sharp tip. o The vial adapter may be configured to reversibly receive a vial. When the vial is placed in the vial adapter, the septum of the vial adapter can be penetrated by the first end of the vent needle and the first end of the fill needle. o The vent needle includes a one-way valve configured to allow air to flow from the interior of the cylinder to the interior of the vial. The end of the filling needle includes a filling needle cap. a fill needle cap configured to seal the end of the fill needle; and / or o The reservoir filling mechanism may be configured within the assist device such that the septum of the cylinder is adjacent to or in contact with the fill port septum.

[0011] In some embodiments, a reservoir filling method for filling a substance into a reservoir of a drug delivery system is provided, for example, including placing a vial into a vial adapter such that the tip of the vent needle and a first tip of the fill needle penetrate a septum of the vial, causing air from the interior of the cylinder to flow through the vent needle into the interior of the vial and push the plunger of the vial adapter toward the closed end of the cylinder, reducing and / or compressing the air trapped inside the cylinder and allowing the substance from the vial to flow into the fill well and the filling conduit. As a result of the pressure differential across the reservoir plunger, the reservoir plunger then increases the volume of the reservoir of the drug delivery system, thereby filling the reservoir with the substance. The method also includes optionally delivering a level of substance in the reservoir that can be used to provide a user with information about the amount of substance in the reservoir.

[0012] In some embodiments, a patch pump assist system is provided, including an assist device including a soft cannula insertion mechanism configured to at least insert a soft cannula into tissue. The device can include a housing, a first exit port septum configured within the cup opening, an exit port well, and a second exit port septum. The system can further include a soft cannula having a lumen and a rigid cannula having a lumen. In some embodiments: - The soft cannula and the rigid cannula each include at least one lateral opening along its length. The housing may be configured to be placed on the skin of a user for cannulation. Prior to insertion, the rigid cannula can be positioned within the soft cannula so that both cannulae initially traverse the cup septum, with the distal ends of the soft and rigid cannulae positioned within the exit port well. - After (or immediately after) insertion, the distal ends of the rigid and soft cannulae are positioned in and / or below the user's skin, with the corresponding lateral openings positioned in the wells. The rigid cannula may be configured to be detached from the soft cannula by retraction of the assist device from the user's skin tissue.

[0013] Such embodiments may include one or more (and in some embodiments, more than one, and in some embodiments, all) of the following additional features, functions, structures, and / or clarifications, which may (in some cases) result in further embodiments: In some embodiments, a cannula bending spring that allows energy stored in the cannula bending spring to be released upon separation of the assist device from the drug / substance delivery system. Energy released by the cannula bending spring moves the rigid cannula from a first position to a second position, the first position can be approximately perpendicular to a side or portion of the housing, and / or the second position can be approximately parallel to a side or portion of the housing. The device may include at least one (and in some embodiments, more than one, and in some embodiments, all) of a trigger, an inserter spring, an inserter hammer, a cup, and a cup septum, which may be configured to fit within the cup opening. The lateral opening of the soft cannula can be aligned with the lateral opening of the rigid cannula. The first end of the rigid cannula is rigidly connected to the inserter hammer. The first end of the cannula may include a stopper configured to prevent the soft cannula from moving out of the end of the cup, although the stopper may be integral with the soft cannula. The cup septum may be configured to seal the interior of the cup. The cup opening may be integral with the housing. The sharp end of the rigid cannula may protrude beyond the end of the soft cannula, and the sharp end of the rigid cannula and the end of the soft cannula may reside at least initially within the exit port well. At least initially, the rigid cannula and the soft cannula can traverse the second exit port septum. The inserter spring may be configured with potential energy. The cannula bending spring may be configured with potential energy. - The cannula bending spring can be prevented from being bent towards the cannula by the sides of the patch pump. - Assist devices can be constructed using reusable and disposable components. The reservoir filling mechanism is configured to fill a reservoir of the patch pump with a substance. - At least one end of the rigid cannula and the soft cannula are sealed, and in some embodiments the end of the soft cannula can establish a seal with the rigid cannula so that insulin or substance to be dispensed can only flow out of the outlet port well during priming via the lateral opening. The system may include an adhesive configured to adhere the device to the user's skin, and / or the soft cannula insertion mechanism may be configured to position the tip of the soft cannula within or under the skin.

[0014] In some embodiments, a drug delivery patch pump system is provided, e.g., a drug delivery patch pump including a reservoir, a dispensing device, an assist device according to an embodiment of the disclosed assist device (and / or corresponding system, e.g., see above). In some embodiments, when filling the reservoir, the pump is configured to prime through the dosing portion such that fluid is pumped through the outlet port conduit, into the fill port well, through the lumen of the rigid cannula, and out the lateral openings of each cannula. In some embodiments, priming is configured to continue until substantially any and all air has exited the dosing portion and / or reservoir, and until the delivered agent begins to flow from the lateral openings of the cannula.

[0015] In some embodiments, a method for inserting a soft cannula for a drug delivery system into a user's tissue is provided, for example, where one or more safety catches include triggering a cannula insertion mechanism to release energy stored in an inserter spring of the inserter mechanism such that an inserter hammer of the inserter mechanism is driven in a first direction, causing the cup, cup opening, cup septum, rigid cannula, and soft cannula of the inserter mechanism to move toward the patient's skin, and the tip of the rigid cannula to pierce the skin and establish a pathway for the soft cannula. In some embodiments, when an end of the cup is at the end of the cup septum, the cup is positioned in the cup opening, lateral openings of the rigid cannula and soft cannula are in fluid communication with the exit port well, and corresponding ends of the rigid cannula and soft cannula are under the patient's skin, the assist device is removed while removing the rigid cannula from the lumen of the soft cannula.

[0016] In some such method embodiments, the energy stored in the cannula bending spring may be released upon separation of the assist device to form the drug / substance delivery system. Additionally, in some embodiments, the method further includes providing one and / or another of the assist devices (e.g., see above) and / or corresponding systems disclosed herein.

[0017] In some embodiments, a closed-loop insulin delivery system is provided, including, for example, a pump, a controller, a charger, and an assist device. Such embodiments may include one or more (and in some embodiments, more than one, and in some embodiments, all) of the following additional features, functions, structures, and / or clarifications, which may (in some cases) result in further embodiments: The pump may include a reusable motor unit and a disposable cannula unit, but the motor unit and cannula unit may be reversibly attachable. The motor unit may include at least one of an electronics module, a drive mechanism, and a power supply. The electronics module may include at least one of a microprocessor, memory, and communication means. o Communication means may include either or both Bluetooth or Wifi (or other short-range communication means). o The memory may store a closed-loop algorithm configured to calculate an instantaneous insulin infusion rate as a function of inputs, which may include past and / or current glucose levels. o The motor unit may include a plurality of electrical contacts electrically connected to the electronics module, the electrical contacts may include one or more contacts, the one or more contacts configured to provide power from the motor unit, and the one or more contacts may be configured to transmit data in analog and / or digital format. The cannula unit may include at least one of a reservoir, a dispensing portion, and an adhesive base. The cannula unit may include a channel traversing from the first side to the second side, the channel optionally configured to at least one of receive a continuous glucose sensor and assist in establishing electrical contact between one or more electrical contacts on the motor unit and one or more contacts on the continuous glucose sensor. The controller may include computer instructions configured to execute and / or operate in combination with a closed-loop algorithm. The assist device may include at least one of a reservoir filling mechanism, a cannulation mechanism, and a disposable / reusable component alignment mechanism. A cannulation mechanism may be configured to store a continuous glucose sensor and insert the sensor under the patient's skin. - Continuous glucose sensor.

[0018] In some embodiments, a continuous glucose sensor configured for use with a closed-loop delivery system according to any one or more of the embodiments disclosed herein includes, for example, one or more (and in some embodiments, more than one, and in some embodiments, all) of the following additional features, functions, structures, and / or clarifications that may (in some cases) result in further embodiments: The sensor includes a head and prongs, one or both of which may include an insulating base such as a biocompatible plastic or ceramic. - One or more electrical contacts may be provided at or within the head of the sensor, the one or more contacts may be configured to interface with corresponding contacts on the motor unit, and / or may include one or more contacts for transmitting power from the motor unit, and / or may include one or more contacts for transmitting analog and / or digital data. The sensor may include an electronic chip (eg, a front-end chip). The sensor may include at least one of an analog-to-digital converter, a working electrode, a counter electrode, and a reference electrode. the sensor includes one or more additional contacts for connection with a reference electrode; The working electrode may include a conductor made of a metal (such as platinum) and an enzyme (such as glucose oxidase), and the working electrode may also be configured to generate a current proportional to the ambient glucose concentration. The membrane (which may be PTFE) may be configured to prevent or substantially prevent interference from non-glucose electrochemically active agents. One or more layers of the working electrode may be printed. The counter electrode may be made of silver and / or silver chloride. The working electrode may be configured for electrical connection to the front end tip via a conductor. The counter electrode may be connected to the tip by a conductor, which may be configured to traverse the prong from the first end to the second end through an opening in the prong. The working electrode may contain a metal catalyst instead of an enzyme, and a selective membrane may be optional. - An area of ​​the tape can be configured with adhesive on at least one side, such that the tape comprises high electrical conductivity in at least one direction (e.g., Z direction) and low electrical conductivity in at least another direction (and preferably two directions) (e.g., X and Y directions). o The tape may include a double-sided adhesive ring or frame that may be configured to establish a waterproof seal around at least one or more of the electrical contacts when pressed between two planar surfaces. The liner may be configured to cover the head of the sensor, the liner including at least one of a plastic layer, a paper layer, and a paper layer covered by a plastic layer. The liner may include a portion facing the motor unit and / or a portion facing the cannula unit, where the portion facing the cannula unit may be folded onto itself and may be connected to a first side (e.g., back side) of the head of the sensor with a connecting layer. o The part facing the motor unit can be folded on itself and connected to the second side (e.g., the front) of the head using tape. o The proximal end of the liner may be connected to a hammer of an assist device insertion mechanism, and / or

[0019] In some embodiments, an assist device for reservoir filling and cannulation for use with a drug delivery device is provided, including, for example, a filling mechanism and an insertion mechanism configured to subcutaneously insert both a cannula and a continuous glucose sensor. In some such embodiments, the device further includes an inserter hammer configured to simultaneously place the cannula and sensor, in some embodiments, through the user's skin and optionally through the drug delivery pump (and optionally via a channel). Further, the hammer may include multiple hammers, each configured to insert one of the cannula and the sensor. In some embodiments, a method of operating a drug delivery system is provided, including at least one, in some embodiments more than one, and in some embodiments all of the following: inserting a motor unit of the drug delivery system into a slot of an assistive device so that a pump from the motor unit can be assembled with a cannula unit of the system; filling the pump with insulin via an insulin filling mechanism; priming the pump; peeling back a liner to expose adhesive on the skin-facing side of the pump; placing the pump at a desired location on a user's skin via the assistive device; and, once the pump is attached to the skin, triggering the cannula unit to insert the cannula and sensor into the user. The insertion may occur via elastic energy stored in a spring, and the force generated by the spring may be transmitted to the cannula and sensor via at least one hammer.

[0020] Some embodiments of the present disclosure are directed to a system or device according to any of the embodiments described and / or illustrated in any one or more of Figures 1-55.

[0021] Some embodiments of the present disclosure are directed to methods according to any of the embodiments described herein and / or illustrated in any one or more of Figures 1-55. The present invention provides, for example, the following. (Item 1) 1. An assist device including a soft cannulation mechanism configured to at least insert a soft cannula into tissue, the device comprising: Housing and a first outlet port septum configured within the cup opening; Exit port well, a second outlet port bulkhead; The flexible cannula has a lumen, and the rigid cannula has a lumen; each of the soft cannula and the rigid cannula includes at least one lateral opening along its length; the housing is configured for placement on a user's skin for cannulation; prior to insertion, the rigid cannula is positioned within the soft cannula such that both cannulae initially traverse the cup septum, and distal ends of the soft cannula and rigid cannula are located within the exit port well; Upon insertion, the distal ends of the rigid and soft cannulas are positioned in and / or below the user's skin, with corresponding lateral openings positioned within the wells; 1. A patch pump assistance system configured to detach the rigid cannula from the soft cannula by retraction of the assistance device from the skin tissue of the user. (Item 2) Item 10. The system of item 1, wherein the assist device includes a cannula bending spring. (Item 3) 3. The system of claim 2, wherein the energy stored in the cannula bending spring is released when at least one of the assist devices is separated from the drug delivery system. (Item 4) 4. The system of claim 2 or 3, wherein the energy released by the cannula bending spring moves the rigid cannula from a first position to a second position. (Item 5) Item 5. The system of item 4, wherein the first position is approximately perpendicular to a side or portion of the housing and the second position is approximately parallel to the side or portion of the housing. (Item 6) 6. The system of any one of items 1 to 5, wherein the device further includes at least one of a trigger, an inserter spring, an inserter hammer, a cup, and a cup septum, and the cup is configured to fit within the cup opening. (Item 7) the device comprising: Item 10. The system of item 1, further comprising a trigger, an inserter spring, an inserter hammer, a cup, and a cup septum, the cup configured to fit within the cup opening. (Item 8) 8. The system of any one of items 2 to 7, wherein the lateral opening of the soft cannula is aligned with the lateral opening of the rigid cannula. (Item 9) Item 10. The system of item 1, wherein the lateral opening of the soft cannula is aligned with the lateral opening of the rigid cannula. (Item 10) 8. The system of claim 6 or 7, wherein a first end of the rigid cannula is rigidly connected to the inserter hammer. (Item 11) 11. The system of any one of items 6, 7, or 10, wherein a first end of the soft cannula includes a stopper configured to prevent the soft cannula from moving out of the end of the cup. (Item 12) Item 8. The system of item 7, wherein a first end of the soft cannula includes a stopper configured to prevent the soft cannula from moving out of the end of the cup. (Item 13) 13. The system according to items 11 to 12, wherein the stopper is integral with the soft cannula. (Item 14) 14. The system of any one of items 6 to 13, wherein the cup septum is configured to seal the interior of the cup. (Item 15) Item 10. The system of item 1, wherein the cup opening is integral with the housing. (Item 16) 8. The system of any one of items 6 or 7, wherein the cup septum is configured to seal the interior of the cup. (Item 17) 17. The system of any one of items 2 to 16, wherein the sharp end of the rigid cannula protrudes beyond the end of the soft cannula. (Item 18) Item 10. The system of item 1, wherein the sharp end of the rigid cannula protrudes beyond the end of the soft cannula. (Item 19) 19. The system of claim 17 or 18, wherein the sharp end of the rigid cannula and the end of the soft cannula are at least initially within the exit port well. (Item 20) Item 10. The system of item 1, wherein at least initially, the rigid cannula and the soft cannula traverse the second exit port septum. (Item 21) 21. The system of any one of items 6 to 20, wherein, at least initially, the inserter spring is configured with potential energy. (Item 22) 8. The system of claim 6 or 7, wherein, at least initially, the inserter spring is configured with potential energy. (Item 23) 20. The system of any one of items 3 to 19, wherein the cannula bending spring is configured with potential energy. (Item 24) Item 3. The system of item 2, wherein the cannula bending spring is configured with potential energy. (Item 25) 25. The system of claim 23 or 24, wherein the cannula bending spring is prevented from bending toward the cannula by the sides of the patch pump. (Item 26) 26. The system of any one of items 2 to 25, wherein the assist device is constructed using reusable and disposable components. (Item 27) Item 10. The system of item 1, wherein the assist device is constructed using reusable and disposable components. (Item 28) 28. The system of any one of items 2 to 27, further comprising a reservoir filling mechanism configured to fill the reservoir of the patch pump with a substance. (Item 29) Item 10. The system of item 1, further comprising a reservoir filling mechanism configured to fill the reservoir of the patch pump with a substance. (Item 30) 30. The system of any one of items 2 to 29, wherein at least one end of the rigid cannula and the soft cannula is sealed. (Item 31) Item 10. The system of item 1, wherein at least one end of the rigid cannula and the soft cannula is sealed. (Item 32) 32. The system of claim 30 or 31, wherein the end of the soft cannula establishes a seal with the rigid cannula so that insulin or substance to be dispensed can only flow out of the outlet port well during priming through the lateral opening. (Item 33) the system includes an adhesive configured to adhere the device to the skin of a user; 33. The system of any one of items 1 to 32, wherein the soft cannula insertion mechanism is configured to position a tip of the soft cannula within or under the skin. (Item 34) a drug delivery patch pump including a reservoir; a medication device; The assistance device or the assistance system according to any one of items 1 to 33, a drug delivery patch pump system configured to prime through the dispensing portion such that, upon filling the reservoir, the pump forces fluid through an outlet port conduit, into a fill port well, through the lumen of the rigid cannula, and out the lateral opening of each cannula. (Item 35) The pump until substantially any and all air has exited the dispensing portion and / or reservoir. and Item 35. The system of item 34, configured to continue priming until at least one of the lateral openings of the cannula begins to flow the agent to be delivered. (Item 36) 1. A method for inserting a soft cannula for a drug delivery system into tissue of a user, the method comprising: an inserter hammer of the inserter mechanism is driven in a first direction; moving the cup, cup opening, cup septum, rigid cannula, and soft cannula of the inserter mechanism toward the patient's skin; The tip of the rigid cannula pierces the skin, establishing a pathway for the soft cannula; and when an end of the cup is at an end of a cup septum, the cup is positioned in the cup opening, the lateral openings of the rigid cannula and the soft cannula are in fluid communication with an exit port well, and the corresponding ends of the rigid cannula and the soft cannula are under the patient's skin, the assist device removes the rigid cannula from the lumen of the soft cannula, while inducing a trigger of a cannula insertion mechanism to release energy stored in an inserter spring of the inserter mechanism to remove the rigid cannula. (Item 37) 37. The method of claim 36, wherein the energy stored in the cannula bending spring is released upon separation of the assist device and the drug delivery system. (Item 38) 38. The method of item 36 or 37, further comprising providing one or another of the devices or systems of items 1 to 35.

[0022] Support for further embodiments, as well as support for specific features / functions disclosed herein and features / functions that may be combined with features / functions of the present disclosure, one and / or another, can be found by reference to the following: - U.S. Patent Application No. 62 / 259,158 (filed May 8, 2015), - International application IL2016 / 050481 (filed May 5, 2016), - U.S. Patent Application No. 15 / 526,736 (filed May 5, 2016), - U.S. Patent Application No. 62 / 519,982 (filed June 15, 2017), and - U.S. Patent Application No. 62 / 551,082 (filed August 28, 2017). Each of the above disclosures is incorporated herein by reference in its entirety. [Brief explanation of the drawings]

[0023] At least some of the embodiments of the present disclosure

[0024] [Figure 1] FIG. 1 shows the main or general components of an insulin delivery system (“IDS”) including a patch pump, according to some embodiments.

[0025] [Figure 2] FIG. 2 shows the disconnected parts of a patch pump according to some embodiments, including, for example, a disposable part (DP) and a reusable part (RP).

[0026] [Figure 3]FIG. 3 shows a spatial view of an assistive device of the system of FIG. 1, according to some embodiments.

[0027] [Figure 4] 4A-D show cross-sectional views of a patch pump (A) and disposables (BD), according to some embodiments.

[0028] [Figure 5] FIG. 5 shows a scheme of the main components of the assist device of FIG. 3 and pre-assembled disposable parts, according to some embodiments.

[0029] [Figure 6] 6, 7A-B, and 8A-B show spatial views of an assist device, according to some embodiments. [Figure 7] Same as above. [Figure 8] Same as above.

[0030] [Figure 9] 9-14 show a scheme of the reservoir filling mechanism of the assist device (FIG. 9) and the operational phases (phase 1→phase 4) of the reservoir filling process (FIGS. 10-14), according to some embodiments. [Figure 10] Same as above. [Figure 11] Same as above. [Figure 12] Same as above. [Figure 13] Same as above. [Figure 14] Same as above.

[0031] [Figure 15] 15-16 show cross-sectional views of a reservoir filling mechanism, a disposable (FIG. 15), and a stand-alone reservoir filling mechanism (FIG. 16), according to some embodiments. [Figure 16] Same as above.

[0032] [Figure 17]17A-C show cross-sectional views of a reservoir filling mechanism during the first three phases of the filling process, according to some embodiments.

[0033] [Figure 18] FIG. 18 shows an enlarged cross-sectional view of the reservoir filling mechanism after the filling process is complete and the vial is disconnected, according to some embodiments.

[0034] [Figure 19] FIG. 19 shows a cross-sectional view of an assist device including some components of a reservoir filling mechanism, a cannulation mechanism, and disposables, according to some embodiments.

[0035] [Figure 20] FIG. 20 shows a schematic cross section of an assist device according to some embodiments of the present disclosure that uses air compression using a plunger and cylinder to force insulin from a vial to a reservoir.

[0036] [Figure 21] 21-26 show schematic cross-sections of the filling mechanism of FIG. 20 during various stages of its operation, according to some embodiments. [Figure 22] Same as above. [Figure 23] Same as above. [Figure 24] Same as above. [Figure 25] Same as above. [Figure 26] Same as above.

[0037] [Figure 27] FIG. 27 shows a schematic cross section of another assist device according to some embodiments of the present disclosure that uses air compression using a plunger and cylinder to force insulin from a vial to a reservoir.

[0038] [Figure 28]28-32 show schematic cross-sections of the filling mechanism of FIG. 27 during various stages of its operation, according to some embodiments. [Figure 29] Same as above. [Figure 30] Same as above. [Figure 31] Same as above. [Figure 32] Same as above.

[0039] [Figure 33] FIG. 33 shows a schematic cross-section of another assist device according to some embodiments of the present disclosure that uses air compression using a plunger and cylinder to force insulin from a vial to a reservoir and utilizes a drive mechanism to move the plunger.

[0040] [Figure 34] 34-35 show schematic cross-sectional views of another assist device, according to some embodiments of the present disclosure, that utilizes a drive mechanism to pull on a reservoir plunger to fill the reservoir with insulin. [Figure 35] Same as above.

[0041] [Figure 36] 36-40 show schematic cross-sections of the filling mechanism of FIGS. 34-35 during various stages of its operation, according to some embodiments. [Figure 37] Same as above. [Figure 38] Same as above. [Figure 39] Same as above. [Figure 40] Same as above.

[0042] [Figure 41] FIG. 41 shows a schematic cross section of yet another assist device according to some embodiments of the present disclosure that uses air compression using a bellows to force insulin from a vial to a reservoir.

[0043] [Figure 42]42A-D show cross-sectional views of a patch pump (A) and its disposable part (BD), according to some embodiments.

[0044] [Figure 43] FIG. 43 shows a schematic cross-section of yet another assist device according to some embodiments of the present disclosure, including a soft cannula and a soft cannula insertion mechanism.

[0045] [Figure 44] 43-45 show schematic diagrams of the assist device of FIG. 43 during various stages of its operation. [Figure 45] Same as above.

[0046] [Figure 46] FIG. 46 shows components of a closed-loop insulin infusion system (artificial pancreas), according to some embodiments.

[0047] [Figure 47] FIG. 47 shows a motor unit of a pump of a closed loop insulin infusion system (artificial pancreas) including electrical contacts on the side facing the cannula unit, according to some embodiments.

[0048] [Figure 48] FIG. 48 shows the motor unit and cannula unit of a pump of a closed-loop insulin infusion system (artificial pancreas), according to some embodiments.

[0049] [Figure 49] 49A-C show top and cross-sectional views of a pump including an artificial pancreas continuous glucose sensor, according to some embodiments.

[0050] [Figure 50] FIG. 50 shows a front view of an artificial pancreas continuous glucose sensor, according to some embodiments.

[0051] [Figure 51]FIG. 51 shows a side view of an artificial pancreas continuous glucose sensor positioned within a channel of an artificial pancreas pump, according to some embodiments.

[0052] [Figure 52] 52-53 show schematic cross-sections of an assist device for an artificial pancreas configured to fill the pump with insulin and place a cannula and continuous glucose sensor in the user, according to some embodiments. [Figure 53] Same as above.

[0053] [Figure 54] FIG. 54 shows a side view of an artificial continuous glucose sensor in the process of being electrically and mechanically connected to an artificial pancreatic pump, according to some embodiments.

[0054] [Figure 55] FIG. 55 shows a side view of an artificial continuous glucose sensor electrically and mechanically connected to an artificial pancreatic pump, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0055] FIG. 1 illustrates components of an insulin delivery system 100, according to some embodiments. The system includes at least one (and in some embodiments, two or more, and in some embodiments, all) of the following components: an insulin patch pump 1 (pump, substance delivery pump, drug delivery pump, and the like), a controller 2, a charger 3, and an assistive device 4. In some embodiments, the controller 2 remotely commands the patch pump 1 and receives alerts and alarms from the patch pump 1. The controller 2 may include a user interface, such as a touchscreen and control buttons. The controller 2 may also communicate with other medication / diabetes management devices (e.g., glucose meters), BLE-enabled devices (PCs, smartphones, tablets, etc.), and the cloud. Additionally, in some embodiments, the controller may include a smartphone and the like.

[0056] In some embodiments, patch pump 1 includes a reusable part (RP) 11 and a disposable part (DP) 12. RP 11 can include one or more (and depending on the device, two or more or all) of a drive mechanism, electronics, and a power source (e.g., a battery). DP 12 can include all or more of an adhesive base, a reservoir, a pumping mechanism, a fill port, an exit port, and a cannula.

[0057] Insulin (and / or another drug or substance) can be configured to be delivered from the reservoir to the outlet port and (in some embodiments) through the cannula and out the outlet port to the body. A power source within RP11 (which in some embodiments may be included in the DP, or a single-use battery) can be charged in charger 3. Assist device 4 connects RP11 and DP12 and can be used for at least one of filling the reservoir, adhering patch pump 1 to the skin, and cannulation. After cannulation, assist device 4 can be discarded.

[0058] FIG. 2 shows the unconnected main components (RP11 and DP12) of a patch pump 1 according to some embodiments. As shown, the DP12 includes an adhesive base 40, a reservoir 20, and a dispensing portion 30. Insulin can be delivered from the reservoir 20 to the dispensing portion 30 and from the dispensing portion 30 to the user's body through a cannula (not shown). According to some embodiments, prior to operation, the user connects the RP11 and DP12 (forming the patch pump 1), fills the reservoir 20, adheres the patch pump 1 to the skin, and inserts the cannula (not shown). At the end of the operating cycle (from patch pump attachment to patch pump removal, i.e., approximately 1-5 days), the user removes the patch pump 1 from the skin, disconnects the RP11 from the DP12, and deploys the DP12. In some embodiments, the patch pump can be provided in a kit including at least two RP11 so that while one RP11 is operating (connected to the DP and attached to the user's body), the second RP11 is charging. Therefore, at the end of one operating cycle, a new DP12 is connected to the charged RP11 (second RP) and the used RP (first RP) is charged.

[0059] FIG. 3 shows a spatial view of the assist device 4, according to some embodiments. The assist device 4 may include at least one (and in some embodiments, two or more, and in some embodiments, all) of a vial connector 80, a RP notch 70, a trigger 52, and a safety catch 51. In one preferred embodiment, the DP (reservoir 20 and adhesive base 40) is pre-assembled on the bottom side of the assist device 4. The adhesive base 40 may include two adhesive / sticky surfaces: a bottom surface for adhering the patch pump 1 to the skin and a top surface for securing the DP 12 to the RP 11 (e.g., after DP-RP connection). The assist device 4 may include at least one of a reservoir filling mechanism (200 in FIG. 5), a cannula insertion mechanism (300 in FIG. 5), and a DR-RP alignment mechanism. The insertion mechanism may be activated by concomitantly applying pressure to the trigger 52 and the safety catch 51 (only one side is shown). The reservoir filling mechanism is activated by connecting an insulin vial to vial connector 80 and pushing the vial against vial connector 80. RP notch 70 may be configured to provide alignment between RP11 and DP12 during RP-DP connection. RP11 (not shown) may be configured to slide over reservoir 20 and connect to DP12 in assist device 4.

[0060] 4A-D show cross-sectional views of a patch pump and DP 12 (BD), according to some embodiments. FIG. 4A shows, for example, patch pump 1 including RP 11 (dashed line) and DP 12. DP 12 can include at least a plurality (in some embodiments, all) of reservoir 20, reservoir plunger 21, dosing portion 30, dosing portion plunger 31, fill conduit 22, fill port septum 23, fill port well 24, exit port conduit 32, exit port well 34, cannula 36, ​​cannula septum 33, cannula opening 35, and reservoir-dosing portion conduit 37.

[0061] Filling of reservoir 20 (in this case, insulin, but which could be any substance for delivery to the user's tissue) can be accomplished using a designated syringe (not shown) or an assist device 4 (FIGS. 3 and 5-19). With a syringe, the user draws insulin from a vial, pierces fill port septum 23 with the syringe needle, and injects the insulin into fill port well 24, through fill conduit 22, and into reservoir 20 (e.g., the syringe is the "delivery tool" for insulin delivery from the vial to patch pump reservoir 20). With assist device 4, insulin is delivered directly from the vial to patch pump reservoir 20 (without the "delivery tool"), where insulin is delivered through fill port septum 23, into fill port well 24, and through fill conduit 22 into reservoir 20.

[0062] The amount of insulin drawn from the vial and injected into reservoir 20 can depend on the user's daily insulin intake and the expected date of use. For example, if the daily intake is 50 units / day (50 U / day) and the replacement cycle (time between replacements) is three days, the amount of insulin required is 150 U (50 U x 3 days). Insulin is delivered from well 24 through fill conduit 22 into reservoir 20. During filling of reservoir 20, reservoir plunger 21 is displaced in the direction of the bold arrow to its final position (downward diagonal). The final position of reservoir plunger 21 is configured to depend on the amount of insulin the user injects into reservoir 20. In FIG. 4A, the reservoir may be marked with four graduations (50 U, 100 U, 150 U, and 200 U), and the reservoir is filled with 150 U, with the final position (downward diagonal) of reservoir plunger 21 being at the 150 U mark.

[0063] During operation of patch pump 1, dosing portion plunger 31 may be configured to be displaced rearward and forward by an RP drive mechanism (not shown). When dosing portion plunger 31 is displaced rearward, insulin may be delivered into dosing portion 30 through reservoir-dosing portion conduit 37. When dosing portion plunger 31 is displaced forward, insulin may be delivered from dosing portion 30 through outlet port conduit 32, outlet port well 34, cannula opening 35, and cannula 36 to the user's body.

[0064] Figures 4B, 4C, and 4D show cross-sectional views of DP12 through cross-sectional planes (dotted lines) yy (4B), zz (4C), and xx (4D), respectively. Figure 4B shows a longitudinal cross-section of plane yy of Figure 4A. DP12 includes reservoir 20, reservoir plunger 21 (black before filling, diagonal downwards at 150 U of insulin after filling), fill conduit 22, fill port septum 23, and fill port well 24. Figure 4C shows a longitudinal cross-section of plane zz of Figure 4A (after cannula 36 insertion). DP12 includes dosing portion 30, dosing portion plunger 31, exit port conduit 32, exit port well 34, cannula 36, ​​cannula septum 33, and cannula opening 35. During insulin administration to a user, insulin can be delivered from dispensing unit 30 through outlet port conduit 32, outlet port well 34, cannula opening 35, and cannula 36 to the user's body. Prior to insertion of cannula 36 (FIG. 5), cannula septum 33 and cannula opening 35 are located outside DP 12, and the tip of cannula 36 is located within DP 12. In some embodiments, DP 12 can be pre-assembled with the assistive device (FIGS. 3, 5-8, and 19), and after filling reservoir 20 and DP-RP connection (within the assistive device), patch pump 1 is adhered to the user's skin with the assistive device, and cannula 36 is inserted by actuation of the cannula insertion mechanism (FIG. 19).

[0065] In some embodiments, during cannulation, cannula 36 and cannula opening 35 are displaced downward to the position shown in FIG. 4C, with cannula septum 33 sealing off exit port well 34, cannula opening 35 located within exit port well 34, and the tip of cannula 36 located below the bottom of DP 12. FIG. 4D shows a transverse cross-section of plane xx of FIG. 4A. DP 12 includes fill port septum 23, fill port well 24, exit port well 34, cannula 36, ​​cannula septum 33, and cannula opening 35.

[0066] FIG. 5 shows a schematic of the major components of the assist device 4 and pre-assembled DP 12. In some embodiments, the assist device 4 can include at least one of a reservoir filling mechanism 200 and a cannulation mechanism 300. In another embodiment (not shown), insulin filling and cannulation can be performed using two separate devices: a filling device and an insertion device (inserter), each of which can have (and in some embodiments have) separate housings. The filling device can consist of the reservoir filling mechanism 200, and the insertion device has the cannulation mechanism 300. Hereinafter, the reservoir filling mechanism 200, according to at least one and / or other embodiments of the present disclosure, can be interchangeably part of the assist device 4 (including the insertion mechanism 300) or a standalone filling device having a separate housing and a separate reservoir filling mechanism 200.

[0067] 5 includes a pre-assembled DP 12, reservoir filling mechanism 200, and cannulation mechanism 300. Reservoir filling mechanism 200 may include at least one (and in some embodiments, two or more, and in some embodiments, all) of vial adapter 41, fill needle 43, vent needle 44, fill piston 42, fill cavity 48, transfer needle 47, piston spring 45, and vent opening 46. Cannulation mechanism 300 may include trigger 52, inserter spring 69, and inserter hammer 54. DP 12 may include fill port septum 23, fill port well 24, exit port well 34, cannula 36, ​​cannula septum 33, and cannula opening 35. Thus, after cannulation, cannula septum 33 is configured to seal exit port well 34, cannula opening 35 is located within exit port well 34, and the tip of cannula 36 is located below the bottom of DP 12 (FIG. 4C). FIG. 5 shows reservoir filling mechanism 200 during the fill phase of cavity 48 (phase 3, FIGS. 8A and 12), in which vial 50 is connected to vial adapter 41 and insulin is delivered from vial 50 to cavity 48. Transfer needle 47 pierces fill port septum 23, with the tip of transfer needle 47 located within fill port well 34.

[0068] 6, 7A-B, and 8A-B show spatial views of assist device 4 (FIG. 6) and operational phases of the reservoir filling mechanism (FIGS. 7A-B and 8A-B), according to some embodiments. First, in vial connection (7A), vial 50 is connected to vial adapter 41, second interval filling (7B), the vial is pushed downward, and insulin is delivered from the vial to cavity 48. Third, in reservoir filling (8A), pressure is removed from vial 50, vial 50 is retracted, and insulin is delivered from cavity 48 to reservoir 20. Fourth, in vial disconnection (8B), vial 50 is removed from assist device 4.

[0069] 6 shows a spatial view of an assist device 4, according to some embodiments. The assist device 4 includes a trigger 52, a safety catch 51, and a vial connector 80. The vial connector 80 may include a vial adapter 41 and a needle protector 53.

[0070] 7A shows a spatial view of the assist device 4 during phase 1 of reservoir filling (vial connection), according to some embodiments. The assist device includes a trigger 52, a safety catch 51, and a vial connector 80 (vial adapter 41 and needle protector 53). During phase 1 of reservoir filling, a vial 50 is connected to the vial adapter 41 (operational scheme of FIG. 10).

[0071] 7B shows a spatial view of the assist device 4 during phase 2 of reservoir filling (void filling), according to some embodiments. The assist device may include a trigger 52, a safety catch 51, and a vial connector 80 (vial adapter 41 and needle protector 53). During phase 2 of reservoir filling, the vial 50 may be forced downward in the direction of the bold arrow. Insulin may be delivered from the vial 50 to the void 48 (operational scheme of FIG. 11).

[0072] 8A shows a spatial view of the assist device 4 during phase 3 of the filling process (reservoir filling), according to some embodiments. The assist device 4 includes a trigger 52, a safety catch 51, and a vial connector 80 (vial adapter 41 and needle protector 53). During phase 3 of the filling process, the vial 50 can be stored in the direction of the bold arrow. Insulin is delivered from the cavity 48 to the reservoir 20 (operational scheme of FIG. 12).

[0073] 8B shows a spatial view of the assist device 4 during phase 4 of the filling process (vial detachment), according to some embodiments. The assist device 4 includes a trigger 52, a safety catch 51, and a vial connector 80 (vial adapter 41 and needle protector 53). During phase 4 of the filling process, the vial 50 is detached from the assist device 4 (operational scheme of FIG. 13).

[0074] 9-14 show a schematic of a reservoir filling mechanism 200 of the assist device 4 (FIG. 9) and the operational phases (phase 1→phase 4) of reservoir filling (FIGS. 10-14), according to some embodiments. FIG. 9 shows a schematic cross-section of the reservoir filling mechanism 200. The reservoir filling mechanism 200 may include more than one, and preferably all, of the vial adapter 41, sliding rod 65, sliding rod opening 67, filling needle 43, vent needle 44, filling piston 42, filling cavity 48, piston conduit 64, transfer needle 47, piston gasket 49, cavity gasket 63, first one-way valve 61, second one-way valve 62, third one-way valve 68, transfer needle 47, graduation mark 60, filling sleeve 66, piston spring 45, and vent opening 46. In some embodiments, the reservoir filling mechanism 200 may be pre-assembled with the DP 12 in the assist device 4 (not shown).

[0075] DP 12 may also include multiple, and preferably all, of fill port septum 23, fill port well 24, fill conduit 22, reservoir 20, and reservoir plunger 21. Transfer needle 47 is configured to pierce fill port septum 23, with the tip of transfer needle 47 residing in fill port well 24. Vial adapter 41 may be connected to fill piston 42 via a cylindrical sliding rod 65. Fill sleeve 66 may include at least one, and in some embodiments multiple, and in some embodiments, all, of a cylinder, which may include multiple, and preferably all, of piston springs 45, fill piston 42, vent opening 46, and fill sleeve opening 67. Cavity gasket 63 may be connected to fill sleeve opening 67 to provide a seal for cavity 48 when sliding rod 65 is linearly displaced (in the direction of bold arrows X and Y) within fill sleeve opening 67. Fill piston 42 may include a gasket 49 that provides a seal for cavity 48 when fill piston 42 is linearly displaced within fill sleeve 66. Displacement of fill piston 42 in the direction of bold arrow X is configured to increase the volume of cavity 48 and compress piston spring 45, while displacement of fill piston 42 in the direction of bold arrow Y is configured to decrease the volume of cavity 48 and expand piston spring 45. Fill needle 43 preferably includes a sharp tip and traverses sliding rod 65. Fill needle 43 may include one-way hydraulic communication with cavity 48 via piston conduit 64 that traverses fill piston 42.

[0076] The first one-way valve 61 provides one-way insulin delivery from the tip of the fill needle 43 through the piston conduit 64 to the cavity 48. The cavity 48 preferably includes one-way hydraulic communication with the reservoir 20 via the transfer needle 47, the fill port well 24, the reservoir filling conduit 22, and the reservoir 20. The second one-way valve 62 preferably provides one-way insulin delivery from the cavity 48 to the reservoir 20 via the transfer needle 47, the fill port well 24, and the reservoir filling conduit 22. The vent needle 44 preferably includes a sharp tip and traverses a sliding rod 65. The vent needle 44 is configured to provide pneumatic communication between the filling sleeve 66 and the tip of the vent needle 44. In some embodiments, a third one-way valve 68 can be provided, which can be disposed at the end of the vent needle 44 within the piston sleeve 66. The third one-way valve 68 is configured to provide one-way air delivery from atmosphere to vial 50, preventing inadvertent insulin delivery if the pressure within vial 50 exceeds atmospheric pressure (e.g., this can occur if the vial is filled with air using a reservoir-filling syringe).

[0077] The vent opening 46 is configured to provide atmospheric pressure (P) equilibrium between the atmosphere and the filling sleeve 66. When a vial is not connected to the vial adapter 41, the pressure at the tip of the vent needle 44 is atmospheric pressure (P), and there is no air movement along the vent needle 44. The sliding rod 65 is preferably configured with graduation markings 60 that provide the user with an indication of the volume of insulin delivered from the vial 50 to the reservoir 20 according to the required insulin intake during an operating cycle (i.e., 1-5 days). FIG. 9 shows examples of markings for 50, 100, 150, and 200 insulin units. During the filling process, the user pushes on the vial 50, moving the vial adapter 41 and sliding rod 65 in the direction of the bold arrow X. The degree of displacement (linear movement of the sliding rod 65 and filling piston 42) is configured to correlate with the amount of insulin delivered from the vial 50 to the reservoir 20. For example, if the desired amount is 150 units (150 U), the user pushes the vial 41 and sliding rod 65 to the 150-unit mark. In another embodiment, the reservoir filling mechanism 200 may be provided with a volume setting knob (not shown) positioned on the sliding rod 65. Rotation of the knob in one direction or the other (e.g., clockwise or counterclockwise) by the user increases or decreases the amount of insulin delivered, respectively. Graduations may be marked on the knob (i.e., 0 U to 200 U). The user rotates the volume setting knob to the desired amount (i.e., 150 units) and pushes the vial 50 ( FIG. 11 ). In another preferred embodiment, the amount of insulin delivered from the vial 50 to the reservoir 20 may be preset to a fixed amount (i.e., 50 insulin units). The degree of downward displacement (bold X) of the sliding rod 65 may be preset, and thus the amount of insulin delivered from the vial 50 to the reservoir 20 with each push is preset. Total amount of insulin delivered = amount (insulin units) x number of pushes, e.g., if the fixed amount is 50 units (50U) and the user requirement for one replacement cycle (i.e., days 1-5) is 150 units (150U), the user should push the vial three times (50U x 3 = 150U).In the example shown in FIG. 9, if the maximum volume of the reservoir is 200U, then the maximum number of presses to achieve full reservoir is accordingly 4 (50U×4=200U).

[0078] 10 shows a cross section of reservoir filling mechanism 200 during phase 1 of the filling process (vial connection), according to some embodiments. Reservoir filling mechanism 200 includes multiple, and preferably all, of vial adapter 41, sliding rod 65, sliding rod opening 67, fill needle 43, vent needle 44, fill piston 42, fill cavity 48, piston conduit 64, transfer needle 47, piston gasket 49, cavity gasket 63, first one-way valve 61, second one-way valve 62, third one-way valve 68, transfer needle 47, graduation mark 60, fill sleeve 66, piston spring 45, and vent opening 46. Reservoir filling mechanism 200 provides for delivery of insulin from vial 50 to reservoir 20 (located within DP 12) through transfer needle 47. DP 12 includes multiple, and preferably all, of fill port septum 23, fill port well 24, fill conduit 22, reservoir 20, and reservoir plunger 21. In phase 1 of the filling process, vial 50 is connected to vial adapter 41. Filling needle 43 and venting needle 44 pierce the rubber septum of vial cover 55.

[0079] 11 shows a cross-sectional schematic of reservoir filling mechanism 200 during phase 2 of the filling process (void filling), according to some embodiments. Reservoir filling mechanism 200 includes a plurality of, and preferably all of, vial adapter 41, sliding rod 65, sliding rod opening 67, fill needle 43, vent needle 44, fill piston 42, fill cavity 48, piston conduit 64, transfer needle 47, piston gasket 49, cavity gasket 63, first one-way valve 61, second one-way valve 62, third one-way valve 68, transfer needle 47, graduation mark 60, fill sleeve 66, piston spring 45, and vent opening 46. DP 12 includes a plurality of, and preferably all of, fill port septum 23, fill port well 24, fill conduit 22, reservoir 20, and reservoir plunger 21. In phase 2 of the filling process, vial 50 is pushed in the direction of the bold arrow while sliding rod 65 and filling piston 42 simultaneously displace in the same direction (bold arrow). The displacement of filling piston 42 creates a negative pressure in cavity 48, which is hermetically sealed by piston gasket 49 and cavity gasket 63. Insulin (wavy lines) within vial 50 follows the pressure gradient and is delivered through filling needle 43, piston conduit 64, and first one-way valve 61 into cavity 48 in the direction of dashed arrow X.

[0080] In the embodiment of FIG. 11 , the sliding rod 65 can be moved to the 150 unit mark, thus filling the cavity 48 with 150 units of insulin. During displacement of the filling piston 42, the piston spring 45 is compressed. The second one-way valve 62 can be configured to prevent air from entering the cavity and creating bubbles. During delivery of insulin from the vial 50 into the cavity 48, the pressure within the vial 50 drops below atmospheric pressure (P−). After the pressure drop within the vial (P−), air follows the pressure gradient and is delivered from the filling sleeve 66 through the vent needle 44 in the direction of the dashed arrow Y and through the optional third valve 68 into the vial 50. At the end of filling phase 2, the pressure within the vial 50 is atmospheric pressure.

[0081] 12 shows a cross-sectional schematic of reservoir filling mechanism 200 during phase 3 of the filling process (reservoir filling), according to some embodiments. Reservoir filling mechanism 200 includes a plurality of, and preferably all of, vial adapter 41, sliding rod 65, sliding rod opening 67, fill needle 43, vent needle 44, fill piston 42, cavity 48, piston conduit 64, transfer needle 47, piston gasket 49, cavity gasket 63, first one-way valve 61, second one-way valve 62, transfer needle 47, graduation mark 60, filling sleeve 66, piston spring 45, and vent opening 46. DP 12 includes a plurality of, and preferably all of the following: fill port septum 23, fill port well 24, filling conduit 22, reservoir 20, and reservoir plunger 21. In phase 3 of the filling process, pressure exerted by the user on vial 50 is removed, releasing the energy stored in compressed piston spring 45. Fill piston 42, sliding rod 65, and vial adapter 41 are displaced in the direction of the bold arrow. Movement of fill piston 42 reduces the volume of cavity 48, displacing insulin temporarily stored in cavity 48 and delivering it in the direction of dashed arrow X through second one-way valve 62, transfer needle 47, fill port well 24, and fill conduit 22 into reservoir 20. During filling of reservoir 20, reservoir plunger 21 is displaced in the direction of the lighter arrow toward the rear of reservoir 20. First one-way valve 61 can be configured to prevent reverse insulin delivery from cavity 48 to the insulin vial. Pressure (P) within vial 50 remains equal to atmospheric pressure within fill sleeve 66.

[0082] 13 shows a cross-sectional schematic of reservoir filling mechanism 200 during phase 4 of the filling process (vial disconnection), according to some embodiments. Reservoir filling mechanism 200 includes multiple, and preferably all, of vial adapter 41, sliding rod 65, fill needle 43, vent needle 44, fill piston 42, cavity 48, piston conduit 64, transfer needle 47, piston gasket 49, cavity gasket 63, first one-way valve 61, second one-way valve 62, third one-way valve 68, transfer needle 47, graduation mark 60, fill sleeve 66, piston spring 45, and vent opening 46. DP 12 includes multiple, and preferably all, of fill port septum 23, fill port well 24, fill conduit 22, reservoir 20, and reservoir plunger 21. In phase 4 of the filling process, vial 50 is removed (curved bold arrow). The pressure within the removed vial 50 is now equal to atmospheric pressure and the vial 50 is ready for another fill cycle.

[0083] FIG. 14 shows a cross-sectional scheme of DP 12 after the filling process is complete and after cannulation and removal of assist device 4 from user's skin 90, according to some embodiments (cannulation mechanism, cannulation, and cannula not shown). DP 12 may also include multiple, and preferably all, of adhesive base 40, fill port septum 23, fill port well 24, fill conduit 22, reservoir 20, and reservoir plunger 21. Reservoir 20 is filled (rocked) and reservoir plunger 21 is in the rear position. The reservoir is filled with 150 units of insulin (150U) (as shown in the example described in FIGS. 10-12).

[0084] 15-16 show cross-sectional views of a reservoir filling mechanism 200 and DP12 (FIG. 15) and a stand-alone reservoir filling mechanism 200 (FIG. 16), according to some embodiments. FIG. 15 shows cross-sectional views of the reservoir filling mechanism 200 and DP12. The reservoir filling mechanism 200 can include a plurality of, and preferably all of, the vial adapter 41, needle protector 53, sliding rod 65, fill needle 43, vent needle 44, fill piston 42, cavity 48, piston conduit 64, transfer needle 47, piston gasket 49, cavity gasket 63, first one-way valve 61, second one-way valve 62, transfer needle 47, fill sleeve 66, piston spring 45, and vent opening 46. The DP12 includes a plurality of, and preferably all of, the fill port septum 23, fill port well 24, fill conduit 22, reservoir 20, and reservoir plunger 21. The needle protector 53 may include a petal-like spring with a band of "leaves" (e.g., one or more leaves). In some embodiments, four leaves are disposed within the vial adapter 41, each of which includes a "leaf" (e.g., four leaves), preferably rigid leaves (spatial diagrams in Figures 6-8). The vial adapter 41 can be displaced linearly downward and upward (bold arrows X and Y) relative to the needle protector 43. Prior to connection of the vial 50 to the vial adapter 41, the needle protector leaves are parallel to the fill needle 43 and the vent needle 44. After removal of the vial 50, the needle protector 53 leaves are reconfigured to bend over both needles 43 and 44, thereby protecting the user from inadvertent self-pricking (Figure 18).

[0085] 16 shows an enlarged cross-sectional view of reservoir filling mechanism 200 prior to vial connection, according to some embodiments. Reservoir filling mechanism 200 includes multiple, and preferably all, of vial adapter 41, needle protector 53, sliding rod 65, fill needle 43, vent needle 44, fill piston 42, cavity 48, piston conduit 64, transfer needle 47, piston gasket 49, cavity gasket 63, first one-way valve 61, second one-way valve 62, transfer needle 47, fill sleeve 66, piston spring 45, and vent opening 46. The leaves of needle protector 53 are shown prior to connection of vial 50 (continuous line 53) and after separation of vial 50 (dashed line 53).

[0086] Figures 17A-C show cross-sectional views of reservoir filling mechanism 200 in the first three phases of the filling process according to some embodiments: Phase 1—Vial Connection (17A), Phase 2—Void Fill (17B), and Phase 3—Reservoir Fill (17C). Figures 17A-C (cross-sectional views) correspond to Figures 10-12 (schemes), respectively: Figure 17A corresponds to Figure 10, Figure 17B corresponds to Figure 11, and Figure 17C corresponds to Figure 12. Reservoir filling mechanism 200 includes more than one, and preferably all, of vial adapter 41, needle protector 53, sliding rod 65, fill needle 43, vent needle 44, fill piston 42, cavity 48, piston conduit 64, transfer needle 47, piston gasket 49, cavity gasket 63, first one-way valve 61, second one-way valve 62, optional third one-way valve 68 (not shown), transfer needle 47, fill sleeve 66, piston spring 45, and vent opening 46. Figure 17A shows phase 1 of the filling process (vial 50 connection). Vial 50 is connected to vial adapter 41, and fill needle 43 and vent needle 44 pierce the vial rubber seal (shown in Figures 10 and 11), bringing the tips of fill needle 43 and vent needle into contact with the vial contents (i.e., insulin).

[0087] FIG. 17B shows phase 2 of the filling process (filling void 48), according to some embodiments. Vial 50 is pushed by the user in the direction of the bold arrow (downward) an amount corresponding to the desired amount of insulin to be filled in the reservoir (i.e., if the amount needed is 150 U, the vial should be pushed until it approaches the 150 U mark) ( FIG. 11 ). Sliding rod 65 and fill piston 42 are displaced in the direction of the bold arrow, compressing piston spring 45. Insulin is delivered from vial 50 into void 48 via fill needle 43, piston conduit 64, and first one-way valve 61. Air follows the pressure gradient and is delivered through vent needle 44 from fill sleeve 66 (atmospheric pressure) to vial 50 (subatmospheric pressure). At the end of the void-fill phase, void 48 is filled with the desired amount of insulin, and the pressure within vial 50 is atmospheric pressure. Figure 17C shows phase 3 of the filling process, which also includes filling the reservoir. Thus, pressure is removed from vial 50, and fill piston 42, sliding rod 65, and vial adapter 41 are displaced in the direction of the bold arrow (release of the energy stored in piston spring 45 during phase 1). The volume of cavity 48 is reduced, and insulin moves from cavity 48 through second one-way valve 62 and transfer needle 47 to the reservoir (Figure 15).

[0088] 18 shows an enlarged cross-sectional view of reservoir filling mechanism 200 after the filling process is completed and the vial has been disconnected, according to some embodiments. Reservoir filling mechanism 200 includes multiple, and preferably all, of vial adapter 41, needle protector 53, sliding rod 65, fill needle 43, vent needle 44, fill piston 42, cavity 48, piston conduit 64, transfer needle 47, piston gasket 49, cavity gasket 63, first one-way valve 61, second one-way valve 62, transfer needle 47, fill sleeve 66, piston spring 45, and vent opening 46. The leaves of the petal-like spring (needle protector 53) bend over fill needle 43 and vent needle 44 to protect the user from inadvertent self-sticks. The spring leaves of needle protector 53 are preloaded into a straight position (parallel to fill needle 43, vent needle 44 and vial adapter 41) and resume their preset shape (spring unloaded) after vial displacement.

[0089] 19 shows a cross-sectional view of assist device 4, including reservoir filling mechanism 200, cannulation mechanism 300, and several components of DP 12. Reservoir filling mechanism 200 (dashed lines) includes a plurality, and preferably all, of vial adapter 41, needle protector 53, sliding rod 65, fill needle 43, vent needle 44, fill piston 42, cavity 48, piston conduit 64, delivery needle 47, piston gasket 49, cavity gasket 63, delivery needle 47, fill sleeve 66, piston spring 45, and vent opening 46. Cannulation mechanism 300 (dashed lines) includes a plurality, and preferably all, of trigger 52 and inserter spring 69 (other parts not shown). DP 12 includes a plurality, and preferably all, of fill port septum 23, fill port well 24, reservoir 20, and reservoir plunger 21. Vial adapter 41 , the tip of fill needle 43 , and the tip of vent needle 44 are preferably located below trigger 52 providing free access to trigger 52 .

[0090] Figure 20 shows a cross section of assist device 401 along plane XX shown in Figure 4. Assist device 401 includes cannulation mechanism 300 and reservoir filling mechanism 201. According to some embodiments, reservoir filling mechanism 201 includes vial adapter 541, plunger 548, vent needle 543, filling needle 544, filling needle cap 545, and cylinder 546.

[0091] Fill needle 544 and vent needle 543 run through the body of plunger 548, with their ends protruding from the tip of the plunger. A first end 550 of plunger 548 may be connected to vial adapter 541. A first end of vent needle 543 and a first end of fill needle 544 may both protrude from first end 550 of plunger 548 into the interior of vial adapter 541. Various other features according to various embodiments may include the following functions / structures / clarifications: A second end of plunger 548 may be configured to slidably or otherwise fit within cylinder 546. An airtight seal between plunger 548 and cylinder 546 may be established by gasket 549. A closed end of cylinder 546 may be configured with a septum 552. The filling and venting needles may be made from metal, such as steel, or plastic. The filling and venting needles may be configured with sharp points on both ends. Vial adapter 541 may be configured to reversibly receive vial 501. Whenever vial 501 is placed in vial adapter 541, the septum of the vial adapter is pierced by a first end of vent needle 543 and a first end of fill needle 544. The vent needle 543 may be configured with a one-way valve 547 that allows air to flow from the interior of the cylinder 546 to the interior of the vial 501 . and / or A filling needle cap 545 may be provided at the second end of the filling needle 544. The filling needle cap 545 may be made of plastic. The filling needle cap 545 may be configured to seal the second tip of the filling needle 544.

[0092] 21-26, cross sections of the reservoir filling mechanism 201 in operation along plane YY of FIG. 4 are shown, according to some embodiments. The reservoir filling mechanism 201 can be configured within the assist device 401 such that the septum 552 of the cylinder 546 is adjacent to or in contact with the fill port septum 23 (FIG. 21). In a first step of filling reservoirs 20 of the pump disposable 12 using the reservoir filling mechanism 401, according to some embodiments, the vial 501 is placed in the vial adapter 541 such that the first tip of the vent needle 543 and the first tip of the fill needle 544 pierce the septum of the vial 501 (FIG. 22). Thus, after placement of the vial 501 in the vial adapter 541, air from the interior of the cylinder 546 can flow through the vent needle 543 and into the interior of the vial 501. Initially, the pressure within the cylinder 543 can be atmospheric pressure P. The pressure inside fill port well 24, fill conduit 22, and outside reservoir plunger 21 may be atmospheric pressure P. The pressure inside vial 501 may be greater than or equal to P. Vial 501 may initially contain a volume of air (not shown) or insulin. End 550 of plunger 548 may initially be positioned near the open end of cylinder 546.

[0093] In a second step (FIG. 23), the user pushes vial 501 downward toward the closed end of cylinder 546, thereby pushing end 550 of plunger 548 toward the closed end of cylinder 546. As a result, the volume of air trapped inside cylinder 546 decreases and the air is compressed. The air pressure within the interior of cylinder 546 increases to P+ > P. Because the interior of cylinder 546 is in fluid communication with the interior of vial 501, the insulin in vial 501 is pressurized to P+. Plunger 543 can advance within cylinder 546 to a position where fill needle cap 545 contacts cylinder septum 552.

[0094] In a third step (FIG. 24), the user continues to push vial 501 toward the closed end of cylinder 546. Filling needle 544 penetrates filling needle cap 545, cylinder septum 552, and fill port septum 23. When the second tip of filling needle 544 exits fill port septum 23 and enters fill well 24, fluid communication is established between the interior of vial 501 and fill well 24. Because pressure P+ in vial 501 is greater than atmospheric pressure P in fill well 24, insulin begins to flow from vial 501 to well 24, and air begins to flow from the interior of cylinder 546 into vial 501 through vent needle 543 (FIG. 25). One-way valve 547 may prevent backflow of insulin or air from vial 501 into cylinder 546. Pressure P+ is established in fill well 24 and filling conduit 22. As a result, reservoir plunger 21 moves backward and insulin enters reservoir 20 (FIG. 25). Insulin fills the reservoir until the pressure in vial 501 and well 24 equals atmospheric pressure (FIG. 26). Vial 501 is then removed from vial adapter 541, completing the filling process.

[0095] 27 shows a cross-section of assist device 402 taken along plane XX shown in FIG. 4. Assist device 402 includes cannulation mechanism 300 and reservoir filling mechanism 202. Reservoir filling mechanism 202 includes vial adapter 641, plunger 648, vent needle 643, fill needle 644, cylinder 646, and conduit 647, which may optionally be equipped with one-way valve 651. Fill needle 644 and vent needle 643 may be configured to protrude from bottom end 650 of vial adapter 641 to pierce a septum of vial 601 and communicate with the interior of vial 601. Vent needle 643 may be in fluid communication with conduit 647, which may be in fluid communication with the interior of cylinder 646. Valve 651 can allow air flow through conduit 647 from the interior of cylinder 646 to vent needle 643, yet prevent air or insulin flow in the reverse direction. Fill needle 644 can be initially positioned across fill port septum 23, thereby allowing fluid communication between the interior of vial 601 and fill well 24. Plunger 648 can be configured to slidably fit within cylinder 646. An airtight seal between plunger 648 and cylinder 646 can be established by gasket 649. Other functions / features / clarifications include the following: The filling and venting needles may be made from metal, such as steel, or plastic. The filling and venting needles may be configured with sharp points on both ends. and / or Vial adapter 641 may be configured to reversibly receive vial 601. Whenever vial 601 is placed within vial adapter 641, the septum of the vial adapter is pierced by a first end of vent needle 643 and a first end of needle 644.

[0096] 28-31, cross sections of the reservoir filling mechanism 202 in operation along plane YY of FIG. 4 are shown, according to some embodiments. Initially, the plunger 648 is positioned within the cylinder 646 so that the gasket 649 is near the opening 652 of the cylinder (FIG. 28). In a first step of filling reservoirs 20 of the pump disposable 12 using the reservoir filling mechanism 202, according to some embodiments, the vial 601 is placed in the vial adapter 641 so that the tip 653 of the vent needle 643 and the first tip 654 of the fill needle 644 pierce the septum of the vial 601 (FIG. 29). Thus, after placing the vial 601 in the vial adapter 641, air from the interior of the cylinder 646 can flow through the vent needle 643 and into the interior of the vial 601. Initially, the pressure within the cylinder 643 can be atmospheric pressure P. The pressure inside fill port well 24, fill conduit 22, and outside reservoir plunger 21 may be atmospheric pressure P. The pressure inside vial 601 may be greater than or equal to P. Vial 601 may initially contain a volume of air (not shown) or insulin.

[0097] In a second step (FIG. 30), the user pushes plunger 648 downward toward the closed end of cylinder 646. As a result, the volume of air trapped inside cylinder 646 decreases and the air is compressed. The air pressure inside cylinder 646 increases to P+ > P. Because the interior of cylinder 646 is in fluid communication with the interior of vial 601, the insulin in vial 601 is pressurized to P+. Insulin flows from vial 601 into fill well 24 and fill conduit 22, whereby it is pressurized to P+. The pressure difference across reservoir plunger 21 causes the reservoir plunger to move backward within reservoir 20, whereby it is filled with insulin. Flow of insulin from vial 601 to cylinder 646 is prevented by optional one-way valve 651, which is necessary especially if vial 601 is initially pressurized. The process continues until the reservoir is completely filled with insulin (reservoir 20 can be equipped with a stopper that prevents plunger 21 from exiting the interior of the reservoir), or until end 656 of plunger 648 reaches closed end 655 of cylinder 646 (FIG. 31), or until the pressure within vial 601 equals atmospheric pressure P. A sensor measuring the level of insulin in reservoir 20 can provide an indication to the user when the desired level of insulin in the reservoir has been reached. Vial 601 is then removed from vial adapter 641 and the filling process is complete (FIG. 32).

[0098] Figure 33 shows a cross section of assist device 403 along plane XX shown in Figure 4. Assist device 403 is similar to assist device 402, except that it includes an automatic mechanism that presses a plunger in a cylinder instead of a manual recess as in device 402.

[0099] Device 403 includes cannulation mechanism 300 and reservoir filling mechanism 203. Reservoir filling mechanism 203 includes vial adapter 741, plunger 748, vent needle 743, fill needle 744, cylinder 746, and conduit 747, which may optionally be equipped with one-way valve 751. Fill needle 744 and vent needle 743 may protrude from bottom end 750 of vial adapter 741 and may be configured to pierce a septum of vial 701 and communicate with the interior of the vial. Vent needle 743 may be in fluid communication with conduit 747, which may be in fluid communication with the interior of cylinder 746. Valve 751 may allow air flow through conduit 747 from the interior of cylinder 746 to vent needle 743, yet prevent air or insulin from flowing in the reverse direction. Fill needle 744 may be initially positioned across fill port septum 23, thereby allowing fluid communication between the interior of vial 701 and fill well 24. Plunger 748 may be configured to slidably fit within cylinder 746. An airtight seal between plunger 748 and cylinder 746 may be established by gasket 749.

[0100] The filling and venting needles may be made from metal, such as stainless steel or plastic. The filling and venting needles may be configured with sharp points on both ends.

[0101] Vial adapter 741 can be configured to reversibly receive vial 701. Whenever vial 701 is placed within vial adapter 741, the septum of the vial adapter is pierced by a first end of vent needle 743 and a first end of needle 744.

[0102] The filling mechanism 203 may include a drive mechanism 770. The drive mechanism may include a power source 771, a controller 772, a motor 773, and a gear 774. The power source may be, for example, a single-use battery or a rechargeable battery. The control unit may be a microcomputer including a microprocessor and memory. The motor may be a DC motor, such as a brush motor, a brushless motor, or a stepper motor. The power source may be a battery of an insulin pump present in the assist device 403, and the controller may be a pump controller. The gear may be coupled to the plunger by means of, for example, a lead screw or a rack. The drive mechanism 770 may also include an input device, such as an operating button.

[0103] In operation, filling mechanism 203 functions mechanically in a manner similar to filling mechanism 202. Accordingly, a detailed mechanical description is omitted. However, in mechanism 203, depression of plunger 748 in cylinder 746 is effected by operation of drive mechanism 770. Upon connection of vial 701 to vial adapter 741, a user instructs drive mechanism 770 to depress plunger 748 in cylinder 746 via an input / output device. Alternatively, a sensor, such as an optical sensor, may detect connection of the vial to the adapter and then automatically instruct drive mechanism 770 to depress plunger 748. Commands from the user or sensor can be delivered to controller 772, which can provide voltage from power source 771 to motor 773. Motor 773 depresses plunger 748 in cylinder 746 via gear 774, thereby delivering insulin from vial 701 to fill well 24 and the pump reservoir, as previously described for mechanism 202.

[0104] Figure 34 shows a cross-section of assist device 404 along plane XX shown in Figure 4. Device 404 includes cannulation mechanism 300 and reservoir filling mechanism 204. Figure 35 shows a cross-section of filling mechanism 204 along plane ZZ shown in Figure 4.

[0105] See FIG. 34 . In some embodiments, reservoir filling mechanism 204 includes vial adapter 841, vent needle 843, fill needle 844, and conduit 847, which may optionally be equipped with one-way valve 851. Fill needle 844 and vent needle 843 may protrude from bottom end 850 of vial adapter 841 and may be configured to pierce a septum of vial 801, communicating with the interior of the vial. Vent needle 843 may be in fluid communication with conduit 847, which may be in fluid communication with the atmosphere. Optional valve 851 may allow air to flow from the atmosphere to vent needle 843 through conduit 847, yet prevent air or insulin from flowing in the reverse direction. Fill needle 844 may be initially positioned across fill port septum 23, thereby enabling fluid communication between the interior of vial 801 and fill well 24.

[0106] See FIG. 35 . In some embodiments, the reservoir filling mechanism 204 may further include a drive mechanism 870 and a connecting string. The drive mechanism may include a power source 871, a controller 872, a motor 873, and a reel 874. The power source may be, for example, a single-use battery or a rechargeable battery. The control unit may be a microcomputer including a microprocessor and memory. The motor may be a DC motor, such as a brushed motor, a brushless motor, or a stepper motor. The power source may be a battery of an insulin pump present in the assist device 404, and the controller may be the pump's controller. The drive mechanism 770 may also include an input device, such as an operating button. The connecting string 880 may have a first end 881 connected to the reel 874 and a second end 882 connected to the reservoir plunger 21. The string 880 may be configured with a nick 883 near its distal end 882. The reservoir 20 may be configured with a stopper 884 located near its open end 885. String 880 may be configured to transmit a pulling force applied by drive mechanism 870 that is sufficient to retract reservoir plunger 882, but to break at nick 883 when the reservoir plunger is pulled by the string against the stopper.

[0107] 35-40, which illustrate a cross section of the assist device 404 in operation along the ZZ plane of FIG. 4, according to some embodiments. In a first step of operation (FIG. 35), the vial adapter 841 is empty, and the reservoir plunger 21 is at the reservoir end near the fill conduit 22. In a second step (FIG. 36), the user inserts the vial 801 into the vial adapter 841. The first end of the fill needle 843 pierces the septum of the vial 801, thereby allowing fluid communication between the interior of the vial and the atmosphere. The first end of the fill needle 844 also pierces the septum of the vial 801. The second end of the fill needle 844 traverses the fill port septum 23, thereby allowing fluid communication between the interior of the vial 801, the fill port well 24, and the fill port conduit 22. In a third step (FIG. 37), the user commands the drive mechanism to fill the reservoir with insulin. Commands may be provided via an input device. Alternatively, a sensor in the vial adapter, such as an optical or mechanical sensor, may detect the presence of the vial 801 in the vial adapter 841 and instruct the drive mechanism to automatically begin insulin filling. Commands from the user or sensor may then be delivered to a controller 872, which may supply voltage from a power supply 871 to a motor 873. The motor may rotate the reel 874 in the direction of the curved arrow (counterclockwise), thereby pulling the connecting string 880 in the direction of the straight arrow (right). The string thus moves the reservoir plunger 21 toward the stopper 884, thereby creating negative pressure inside the vial 801. Thus, insulin flows from the vial to the reservoir. Air from the atmosphere flows through the vent needle 843 and, optionally, through the valve 851 into the vial 801, thereby displacing the insulin provided to the reservoir in the vial. This process may continue until the reservoir plunger 21 reaches the stopper 884, indicating the end of reservoir filling (FIG. 38). The drive mechanism continues to pull the string 880 against the stopper 884 until the string 880 breaks at the nick 883 (FIG. 39), at which point the drive mechanism 870 stops rotating the reel 874, for example, by command from a motor current sensor or a motor revolution counter.The vial 801 can be removed from the vial adapter 841 completing the filling process (FIG. 40).

[0108] 41 shows a cross-section of assist device 405 along plane XX shown in FIG. 4, according to some embodiments. Assist device 405 includes cannulation mechanism 300 and reservoir filling mechanism 205. Reservoir filling mechanism 205 is similar to reservoir filling mechanism 201 of device 401, except that cylinder 546 and plunger 548 of mechanism 201 are replaced with bellows 949 within filling mechanism 205.

[0109] Reservoir filling mechanism 205 includes vial adapter 941, shaft 948, vent needle 943, fill needle 944, fill needle cap 945, and foldable bellows 949. Fill needle 944 and vent needle 943 run through the body of shaft 948, with their ends protruding from the tip of the shaft. A first end 950 of shaft 948 can be connected to vial adapter 941. A first end of vent needle 943 and a first end of fill needle 944 can both protrude from first end 950 of plunger 948 into the interior of vial adapter 941.

[0110] A second end of shaft 948 may be connected to a first end 951 of bellows 949. A second end 954 of bellows 949 may be configured with a bellows septum 952. The connection of the bellows to the shaft may be airtight.

[0111] The filling and venting needles may be made from a metal such as steel or plastic. The filling and venting needles may be configured with sharp points on both ends.

[0112] Vial adapter 941 can be configured to reversibly receive vial 901. Whenever vial 901 is placed in vial adapter 941, the septum of the vial adapter can be pierced by a first end of vent needle 943 and a first end of needle 944.

[0113] Vent needle 943 may optionally be configured with a one-way valve 947 that allows air to flow from the interior of cylinder 943 to the interior of vial 901, but prevents air or fluid from flowing from the interior of the vial to the interior of the bellows.

[0114] A fill needle cap 945 may be provided at the second end of the fill needle 943. The fill needle cap 945 may be made of plastic. The fill needle cap 945 may be configured to seal the second tip of the fill needle 945.

[0115] The operation of fill mechanism 205 is similar to fill mechanism 201; therefore, a detailed description thereof will be omitted. Briefly, the first step is to connect vial 901 to vial adapter 941. Fluid communication is established between the interior of bellows 949 and the interior of vial 901. Next, the user presses down on the vial, thereby compressing the air trapped within the bellows. The increased pressure is transmitted to the interior of the vial. This continues until fill needle cap 945 contacts bellows septum 952. The user then continues to press the bottle, thereby causing fill needle 944 to continue to penetrate the cap, bellows septum, and fill port septum 23. Fluid communication is established between the interior of the vial and fill port well 24. The increased pressure in the vial causes insulin to flow from the vial to the fill port well. The increased pressure in the fill port retracts the reservoir plunger, thereby filling the reservoir with insulin. Once the reservoir is filled, the vial is disconnected from the vial adapter, and the filling process is complete.

[0116] Referring to Figure 42, various schematic views of an insulin pump 302 are shown, according to some embodiments. Figure 42A shows a schematic top view of the pump 302. Figure 42B shows a schematic cross-section along plane YY. Figure 42C shows a schematic cross-section along plane ZZ, and Figure 42D shows a schematic cross-section along plane XX.

[0117] Pump 302 is very similar to pump 1 described above, except that disposable 12 is replaced with disposable 312. Disposable 312 is very similar to disposable 12 except that (1) outlet port septum 33 is replaced with top outlet port septum 313 configured in cup bore 385 integrated with disposable 312, (2) outlet port well 34 is replaced with outlet port well 314, and (3) adds bottom outlet port septum 311 (FIGS. 42C and D).

[0118] 43 , a schematic diagram of an assist device 406 including a pump 302 assembled therein is shown, according to some embodiments. Assist device 406 includes reservoir filling mechanism 200, as described above, as well as soft cannulation mechanism 301. Soft cannulation mechanism 301 includes trigger 352, inserter spring 369, inserter hammer 354, steel cannula 336 (also referred to as a rigid cannula), soft cannula 377, cup 381, and cup septum 382. Cup 381 is ultimately configured to fit snugly (i.e., tightly) within cup bore 385.

[0119] Steel cannula 336 may be made from a metal such as steel, or from a hard plastic, for example. Soft cannula 377 may be made from a soft plastic such as Teflon, for example. Steel cannula 336 may be configured with a steel cannula side hole 337. Soft cannula 377 may be configured with a soft cannula side hole 378. First, steel cannula 336 may be placed within the lumen of soft cannula 377 so that side holes 337 and 378 are aligned.

[0120] The upper end of the steel cannula 336 may be rigidly connected to the inserter hammer 354. The upper end of the soft cannula 377 may include a stopper 379 configured to prevent the soft cannula 377 from slipping off the bottom end of the cup 381. The stopper may be integral with the cannula. The cup septum 382 may seal the interior of the cup 381. The steel needle 336 may initially traverse the cup septum 382. Initially, the sharp bottom end of the steel cannula 336 may protrude beyond the bottom end of the soft cannula 377. Both ends may initially reside in the exit port well 314. Initially, both the steel cannula 336 and the soft cannula 377 may traverse the top exit port septum 313. Initially, the inserter spring 369 may be cocked, i.e., placed in a state in which the inserter spring contains potential energy. Cannula bending spring 371 may also be cocked (ie, placed in a state where the bending spring contains potential energy) and prevented from bending toward the cannula by the sides of pump 302.

[0121] See Figures 43-45. According to some embodiments, in operation, assist device 406 may be used as described above to assemble pump 302 from reusable and disposable components. Reservoir filling mechanism 200 may be used to fill the reservoir with insulin. Once the reservoir is fully filled, the pump is primed by operating dosing unit 30 to pump fluid through outlet port conduit 32 into fill port well 314 and from there out the lumen and side holes 337 and 378 of steel cannula 336 (Figure 43). The priming process may continue until air escapes from the dosing unit and reservoir and insulin drips out of side hole / opening 378. The top end of steel cannula 336 may be sealed, and the top end of soft cannula 377 may form a tight seal with steel cannula 336, so that the only way insulin can flow out of outlet port well 314 during priming is through side holes 337 and 378.

[0122] Once priming is complete, the user can peel the liner from the adhesive base (not shown) and reversibly position the pump 302 on the body using the assist device 406. Next, the user can use the soft cannula insertion mechanism 301 to place the bottom tip of the soft cannula 377 under the skin. This can be done in the following manner ( FIG. 43 ). First, the user presses the trigger 352 and safety catch (not shown) to release the energy stored in the cocked inserter spring 369 and drive the inserter hammer 354 in a bottom direction. Thus, the cup 381, cup septum 382, ​​steel cannula 336, and soft cannula 377 can move toward the patient's skin. The sharp tip of the steel cannula 336 can puncture the skin and subcutaneous tissue, creating a path for the soft cannula 377 to follow. The insertion process may be completed when the bottom of cup 381 rests on upper septum 313, cup 381 is positioned within cup hole 385, and side holes 337 and 378 are in fluid communication with exit port well 314 (FIG. 44). The bottom ends of steel cannula 336 and soft cannula 377 are under the patient's skin.

[0123] The user can then remove the assist device 301 (FIG. 45), thereby removing the steel cannula 336 from the lumen of the soft cannula 377. The elastic energy stored in the cannula bending spring 371 can be released upon separation of the assist device and the pump. The spring may bend toward the steel cannula 336, bending the steel cannula into the interior of the assist device. Thus, sharp injuries from the steel cannula are prevented. The pump 302 remains attached to the patient's body, and the soft cannula 377 is percutaneously inserted at its bottom end beneath the patient's skin, with the side hole 378 in fluid communication with the exit port well 314. The user and the dispensing unit 30 are in fluid communication via the exit port conduit 32 (FIG. 42C), the exit port well 314, the soft cannula side hole 378, and the patient's subcutaneous tissue. Because cup septum 382 seals when steel cannula 336 is removed, the only place insulin can flow from dispensing portion 30 is to the user. The pump is now ready to deliver insulin to the user.

[0124] It should be noted that any combination of reservoir filling mechanisms 200, 201, 202, 303, 204, or 205 may be used in combination with either cannulation mechanism 300 or soft cannulation mechanism 301 to produce an assist device.

[0125] 46, a closed-loop insulin delivery system (or artificial pancreas) 1000 is shown, according to some embodiments. The closed-loop system 1000 may include a pump 1001, a controller 1002, a charger 3, and an assist device 1004. The pump 1001 includes a reversibly attachable, reusable motor unit 1011 and a disposable cannula unit 1012.

[0126] According to some embodiments, the motor unit 1011 is substantially similar to the motor unit 11 described above. As such, it may include an electronics module, a drive mechanism, and a battery (all not shown). The electronics module may include a microprocessor, memory, and communications, such as Bluetooth Low Energy (BLE). The memory may include software containing a closed-loop algorithm that calculates instantaneous insulin infusion rates as a function of inputs, including, for example, past and current glucose levels sensed by a continuous glucose sensor. The motor unit 1011 (FIG. 47) may include electrical contacts 1020 electrically connected to the electronics module. The electrical contacts 1020 may include one or more contacts. The electrical contacts 1020 may include four contacts, with two contacts 1021 configured to provide power from the motor unit and two contacts 1022 configured to transmit data. The data may be transmitted in analog or digital format.

[0127] According to some embodiments, cannula unit 1012 (FIG. 48) is substantially similar to the previously described cannula unit 12. Like the corresponding portions of cannula unit 12, cannula unit 1012 may include a reservoir portion 20, a dispensing portion 30, and an adhesive base 40. The primary difference is that cannula unit 1012 may include a channel 1013 that traverses it from top to bottom. Channel 1013 is configured to receive a continuous glucose sensor signal and assist in establishing electrical contact between contacts 1020 on the motor unit 1011 and the continuous glucose sensor.

[0128] According to some embodiments, controller 1002 is substantially similar to controller 2 of system 1, except that it may include additional software that supports the closed-loop algorithms of system 1000. The charger of system 1000 is similar to charger 3 of system 1.

[0129] According to some embodiments, assistive device 1004 is similar to assistive device 4, except that it includes a modified inserter module that stores a continuous glucose sensor and can insert it under the patient's skin.

[0130] Reference is now made to FIG. 49. FIG. 49A shows a schematic top view of the pump 1001 when positioned on a user, according to some embodiments. The plane at which the motor unit 1011 interfaces with the cannula unit 1012 is designated WW, and the plane parallel to WW and intersecting the fill port septum 23 and the outlet port septum 33 is designated XX. A continuous glucose sensor 1050 is disposed in the channel 1013. FIG. 49B shows a cross-section of the pump 1001 along the plane WW with the continuous glucose sensor 1050 disposed in the channel 1013, with the pointed end of the sensor 1050 protruding beyond the skin-facing plane of the pump 1001. FIG. 49C shows a cross-section of the pump 1001 along the plane XX, with the sharp end of the cannula 36 protruding from the skin-facing plane of the pump 1001.

[0131] Referring to FIG. 50 , a front view of a continuous glucose sensor 1050 is shown, according to some embodiments. The sensor 1050 includes a head 1051 and prongs 1052, both of which may include a base made of an insulator such as a biocompatible plastic or ceramic. Electrical contacts 1060 may be disposed on the head by, for example, printing. The electrical contacts 1060 may include one or more contacts configured to contact the contacts 1020 on the motor unit 1011. The electrical contacts 1060 may include four contacts, including a pair of contacts for transmitting power from the motor unit and a pair of contacts 1062 for transmitting analog or digital data. The sensor 1050 may include a front-end chip 1070 ( FIG. 51 ) that includes an analog-to-digital converter, a working electrode 1080, and a counter electrode 1090 on its back surface. The sensor 1050 may optionally include a reference electrode (not shown). Whenever a reference electrode is used, the additional contacts 1020 and 1060 may include five or more contacts.

[0132] The working electrode 1080 (FIG. 51) may include a conductor 1081 made from a metal such as platinum, an enzyme 1082, such as glucose oxidase, configured to generate a current proportional to the ambient glucose concentration, and a selective membrane 1082, such as PTFE, configured to prevent interfacing from non-glucose electrochemically active agents. The various layers of the working electrode may be printed. The counter electrode 1090 may be made from silver or silver chloride, for example. The working electrode 1080 may be electrically connected to the front-end tip 1070 by a conductor 1066. The counter electrode 1090 may be connected to the front-end tip 1070 by a conductor 1067 configured to traverse the prong 1052 from front to back through a hole in the prong.

[0133] The working electrode 1080 may contain a metal catalyst instead of an enzyme. The selective membrane 1082 may be optional.

[0134] The electrical contacts 1060 may be covered by tape 1063, which may be adhesive on both sides. The tape 1063 may have high electrical conductivity in the Z direction and very low electrical conductivity in the X and Y directions. For example, the tape 1063 may be Z-axis conductive tape made by 3M. Optionally, the tape 1063 may be surrounded by a double-sided adhesive ring or frame, which may create a waterproof seal around the contacts 1020 and 1060 when pressed between two planar surfaces (not shown). The contacts 1061 may be electrically connected to a front-end chip 1070 by power supply conductors 1064, and data may be transmitted to and from the chip 1070 by data conductors 1065.

[0135] According to some embodiments, the head of the sensor 1050 may be covered by a liner 1100 ( FIG. 51 ). The liner 1100 may be manufactured from, for example, a thin layer of plastic, a thin layer of paper, or a thin layer of paper covered with a plastic layer. The liner 1100 may include a portion facing the motor unit (MU-facing portion) 1101 and a portion facing the cannula unit (CU-facing portion) 1102. The CU-facing portion 1102 may be folded on itself and connected to the rear side of the head 1051 using an adhesive layer. The MU-facing portion 1101 may also be folded on itself and connected to the front of the head using tape 1063. The proximal end 1103 may be connected to the hammer 1054 of the insertion mechanism 1300 of the assist device 1004 ( FIG. 52 ).

[0136] 52 and 53 , assist device 1004 is shown schematically, according to some embodiments. Assist device 1004, according to some embodiments, is similar to assist device 4, for example. It includes a filling mechanism 200 and an insertion mechanism 1300 configured to subcutaneously insert both cannula 36 and a continuous glucose sensor 1050. FIG. 52 shows a schematic cross-section of assist device 1004 along the XX plane shown in FIG. 49A , and FIG. 53 shows a schematic cross-section of assist device 1004 along the WW plane shown in FIG. 49A . The primary differences between assist device 1004 and assist device 4 are that device 1004 includes pump 1001 instead of pump 1, insertion mechanism 1300 includes sensor 1050, and inserter hammer 54 is replaced with inserter hammer 1054. The inserter hammer 1054 is configured to simultaneously place both the cannula 36 and the sensor 1050 through the pump (the latter via channel 1013) and across the user's skin. Alternatively, two separate hammers may be used in the insertion mechanism 1300 to insert the cannula and the sensor.

[0137] Operation of system 1000, according to some embodiments, is similar to that of system 1 described above. Motor unit 1011 may be inserted into a slot in assist device 1004, thereby assembling pump 1001 from motor unit 1011 and cannula unit 1012. Pump 1001 may be filled with insulin using insulin filling mechanism 200, as described above. The pump may then be primed using commands from controller 1002. The adhesive on the skin-facing side of pump 1001 may be exposed by peeling back a liner (not shown). Assist device 1004 may then be used to place pump 1001 on the user's skin at a desired location. Once the pump is adhered to the skin, trigger 52 may be pressed to fire the cannula and sensor by releasing the elastic energy stored in spring 69. The force generated by the spring may be transmitted to cannula 36 and sensor 1050 by hammer 1054.

[0138] The sharp tips of the prongs 1052 may pierce the skin of the user. Alternatively, a guide needle (not shown) may be used to pierce the skin and guide the prongs 1052.

[0139] 51 shows the sensor 1050 immediately after being driven through the channel 1013 by the hammer 1054, according to some embodiments. The fold 1102 facing the CU of the liner 1100 is located between the cannula unit 1012 and the back surface of the sensor head 1051. The fold 1101 facing the MU of the liner 1100 is located between the front surface of the sensor head 1051 and the motor unit 1011. The contacts 1020 on the motor unit align with corresponding contacts 1060 on the sensor head.

[0140] To complete connection of the artificial pancreas 1001 to the user, in some embodiments, the assist device 1004 can be pulled away from the patient's skin ( FIG. 54 ). This causes the MU-facing fold 1101 of the liner 1100 to peel away from the tape 1063, exposing the tape. This also causes the CU-facing fold 1102 to push the sensor head 1051 toward the motor unit 1011, thereby electrically connecting the sensor 1050 and the motor unit 1011 due to the high conductivity of the tape in the Z direction. The low conductivity in the X and Y directions ensures sufficiently low crosstalk between non-corresponding contacts. Furthermore, because signals transmitted through contacts 1022 and 1062 are digitized by the front-end chip 1070 and not transmitted in a more error-prone analog form, the system is less susceptible to crosstalk. The tape 1063 can cover the contacts 1060 on one side and the contacts 1029 on the other side, sealing them in a waterproof manner.

[0141] Figure 55 shows the sensor in its subcutaneously inserted configuration, according to some embodiments, and electrically connected to the pump 1001 via the motor unit. Thus, the artificial pancreas 1000 is ready for operation.

[0142] While various inventive embodiments have been described and illustrated herein, those skilled in the art will readily conceive of numerous other means and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is deemed to be within the scope of the inventive embodiments described herein. Moreover, those skilled in the art will generally recognize that all parameters, dimensions, materials, and configurations described herein are intended to be examples, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application or applications for which the teachings of the present invention are used. Those skilled in the art will recognize or be able to ascertain, using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. Therefore, it will be understood that the foregoing embodiments are presented by way of example only, and that, within the scope of the appended claims and their equivalents, the invention may be practiced otherwise than as specifically described and claimed. The inventive embodiments of the present disclosure are directed to each individual feature, function, system, article, material, kit, and / or method / step described herein. Additionally, combinations of two or more such features, systems, articles, materials, kits, and / or methods / steps are within the inventive scope of this disclosure, provided that such features, systems, articles, materials, kits, and / or methods / steps are not mutually inconsistent. Some embodiments may be distinguishable over the prior art by specifically lacking one or more features / elements / functions (i.e., claims to such embodiments may include one or more negative limitations).

[0143] Furthermore, and with respect to various inventive concepts embodied as one or more methods, the acts performed as part of the method may be ordered in any suitable manner. Thus, embodiments may be constructed to perform acts in an order different from that illustrated, which may include performing some acts simultaneously despite being shown as sequential acts in the illustrated embodiments.

[0144] All references to publications or other documents, including, but not limited to, patents, patent applications, articles, web pages, books, etc., presented anywhere in this application are incorporated herein by reference in their entirety. Furthermore, all definitions defined and used herein should be understood to supersede dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0145] As used herein, the indefinite articles "a" and "an" in the specification and claims, unless clearly indicated to the contrary, should be understood to mean "at least one."

[0146] As used herein, the phrase "and / or" in the specification and claims should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or" should be construed in the same manner, i.e., "one or more" of the elements so conjoined. Other elements other than the elements specifically identified by the "and / or" clause can optionally be present, whether related to the specifically identified elements or not. Thus, as a non-limiting example, a reference to "A and / or B," when used with open-ended language such as "comprising," could, in one embodiment, refer to A only (optionally including elements other than B); in another embodiment, refer to B only (optionally including elements other than A); in yet another embodiment, refer to both A and B (optionally including other elements); and so forth.

[0147] As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, the disjunctive items "or" or "and / or" in a list should be construed as inclusive, i.e., including at least one, but also two or more, of several elements or a list of elements, and optionally additional unlisted items. Only terms clearly indicating the contrary, such as "only one of" or "exactly one of," or "consisting of" as used in the claims, shall refer to the inclusion of exactly one element of several elements or a list of elements. In general, the term "or" as used herein should be construed to indicate exclusive alternatives (i.e., "one or the other, but not both") only when preceded by exclusive terms, such as "either," "one of," "only one of," or "exactly one of." As used in the claims, "consisting essentially of" shall have its ordinary meaning as used in the field of patent law.

[0148] As used herein in the specification and claims, the phrase "at least one" in reference to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but does not necessarily include at least one of every element specifically listed in the list of elements, and does not exclude any combination of elements in the list of elements. The definition also allows for the optional presence of other elements, whether related or not to the specifically identified elements, in the list of elements to which the phrase "at least one" refers. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B," or, equivalently, "at least one of A and / or B") could refer in one embodiment to at least one (optionally including more than one) A, but no B (optionally including elements other than B); in another embodiment to at least one (optionally including more than one) B, but no A (optionally including elements other than A); in yet another embodiment to at least one (optionally including more than one) A, and at least one (optionally including more than one) B (optionally including other elements); and so on.

[0149] All transitional phrases in the claims and the above specification, such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like, are to be understood to be open-ended, i.e., to mean inclusive without limitation. Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in the U.S. Patent Office Guidelines for Patent Examination, Section 2111.03.

Claims

1. A drug delivery system comprising: a drug delivery patch pump including a reusable part (RP) and a disposable part (DP), a pump, a reservoir, a dispensing device, a cup, a cup opening, and a cup septum; an assist device including a housing, the housing having a side opening for receiving the drug delivery patch pump prior to use, a cannula insertion mechanism with a trigger, an inserter spring, a safety catch for enabling release of energy stored in the insertion mechanism, an inserter hammer, a soft cannula, and a rigid cannula; Equipped with When the insertion mechanism is activated, the inserter hammer moves in a first direction to drive the rigid cannula and the soft cannula toward the patient's skin, causing the tip of the rigid cannula to pierce the skin and establish a pathway for the soft cannula.

2. The system of claim 1, wherein when filling the storage section, the pump is configured to prime through the dispensing section so that fluid is pumped through an outlet port conduit, into a fill port well, through the lumen of the rigid cannula, and out through the lateral openings of each of the soft cannula and the rigid cannula.

3. The system described in claim 2, wherein the pump is configured to continue priming until substantially any and all air has exited the dispensing section and / or the storage section and / or until drug delivery begins to flow from the lateral opening of the cannula.

4. A system described in any of claims 1 to 3, wherein the lateral opening of the soft cannula is aligned with the lateral opening of the rigid cannula.

5. A system described in any one of claims 1 to 4, wherein a first end of the rigid cannula is firmly connected to the inserter hammer.

6. A system described in any of claims 1 to 5, wherein a first end of the soft cannula includes a stopper configured to prevent the soft cannula from moving out from the end of the cup.

7. The system described in claim 6, wherein the stopper is integral with the soft cannula.

8. A system described in any one of claims 1 to 7, wherein the cup septum is configured to seal the inside of the cup.

9. The system described in claim 1, wherein the cup opening is integral with the housing.

10. A system described in any of claims 1 to 9, wherein the sharp end of the rigid cannula protrudes beyond the end of the soft cannula.

11. A system described in any of claims 1 to 10, wherein the sharp end of the rigid cannula and the end of the soft cannula are, at least initially, present within the outlet port well.

12. A system as described in any of claims 1 to 11, wherein, at least initially, the rigid cannula and the soft cannula cross the second outlet port bulkhead.

13. A system described in any one of claims 1 to 12, wherein, at least initially, the inserter spring is configured to have potential energy.

14. A system described in any one of claims 1 to 13, wherein at least one end of the rigid cannula and the soft cannula is sealed.

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