Infusion pump deployment system and method

Abstract

Infusion pump deployment systems and related methods are described. In one embodiment, a cannula system can simultaneously deploy a cannula of a device into tissue and release the device from the cannula system upon actuation. Related methods and configurations of cannula systems and devices are also described.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 049,024, filed July 7, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The disclosed embodiments relate to infusion pump deployment systems and methods. Background Technology

[0004] Portable infusion pumps are typically used to deliver desired compositions, such as therapeutic compounds, to a subject over extended periods. Depending on the specific application, portable infusion pumps can be used to deliver the desired composition subcutaneously, epidurally, and / or intravenously. Portable infusion pumps are commonly used to deliver these compositions to subjects requiring continuous and / or repeated infusions for specific treatments. For example, certain conditions such as diabetes, cancer, chronic pain, infections, gastrointestinal disorders, and other conditions can benefit from treatment using portable infusion pumps. Summary of the Invention

[0005] In one aspect, a method is provided. In some embodiments, the method of deploying an infusion pump includes positioning a device containing a cannula and held in a cannula inserter adjacent to a surface, and actuating the cannula inserter to simultaneously deploy the cannula into the surface and release the device from the cannula inserter.

[0006] On the other hand, a system is provided. In some embodiments, the system includes a device comprising a cannula and a cannula inserter. The device is initially connected to the cannula inserter, and the cannula inserter is configured to hold the device prior to actuation. The cannula inserter is also configured to simultaneously deploy the cannula of the device and release the device during actuation.

[0007] In another aspect, a cannulation inserter is provided. In some embodiments, the cannulation inserter includes: a first locking member configured to selectively connect a device including a cannula to the cannulation inserter; an inserter needle configured to move between an undeployed configuration and a deployed configuration; a second locking member configured to selectively retain the inserter needle in the undeployed configuration; and a trigger. Actuation of the trigger is configured to unlock the first locking member to allow the inserter needle to move from the undeployed configuration to the deployed configuration, and to unlock the second locking member to release the device.

[0008] In yet another aspect, an infusion pump is provided. In some embodiments, the infusion pump includes a chamber in fluid communication with one or more reservoirs, a first septum configured to seal a first portion of the chamber, an opening formed in a second portion of the chamber, a support collar configured to be inserted into the opening and seal the opening in a deployed configuration, and a cannula connected to and extending from the support collar. The cannula is configured to extend through the first septum to an exterior of the infusion pump in the deployed configuration.

[0009] In yet another aspect, a method is provided. In some embodiments, the method includes deploying a cannula through a first septum of a chamber with a needle inserter to place the chamber in fluid communication with an exterior of an infusion pump, and sealing a second portion of the chamber with a second septum connected to the cannula. The needle inserter passes through the second septum and the cannula.

[0010] In yet another aspect, an infusion pump is provided. In some embodiments, the infusion pump includes a chamber in fluid communication with one or more reservoirs, a first septum configured to seal a first portion of the chamber, a second septum configured to seal a second portion of the chamber, and a cannula. The cannula is connected to and extends from the second septum into an interior of the chamber, and the cannula extends through the first septum to an exterior of the infusion pump.

[0011] In any of the above embodiments, releasing the device includes deforming the two arms out of engagement with the respective portions of the device.

[0012] In any of the above embodiments, deforming the two arms includes deforming the two arms relative to a portion of the needle inserter as the needle inserter moves between the undeployed configuration and the deployed configuration to deploy the cannula.

[0013] In any of the above embodiments, actuating the cannula inserter includes disengaging the first lock from the needle inserter by way of a cam to allow the needle inserter to move from the undeployed configuration to the deployed configuration to deploy the cannula.

[0014] In any of the above embodiments, the method includes sealing a portion of a chamber of the device with a septum connected to the cannula as the cannula is deployed.

[0015] In any of the above embodiments, the method includes retracting the needle from the cannula and the device while the cannula is retained on the device.

[0016] In any of the above embodiments, deploying the cannula includes deploying a needle of an inserter on which the cannula is disposed.

[0017] In any of the above embodiments, the device includes a septum. In some embodiments, the cannula is connected to and extends from the septum, and the septum is configured to seal at least a portion of the chamber of the device when the cannula is in the deployed configuration.

[0018] In any of the above embodiments, movement of the inserter needle of the device toward the deployed configuration releases the device from the cannula inserter.

[0019] In any of the above embodiments, movement of the inserter needle from the undeployed configuration to the deployed configuration unlocks the second lock.

[0020] In any of the above embodiments, the first lock includes two opposing arms configured to engage respective portions of the device to selectively connect the device to the cannula inserter.

[0021] In any of the above embodiments, movement of the inserter needle from the undeployed configuration to the deployed configuration deforms the two opposing arms out of engagement with the respective portions of the device to release the device.

[0022] In any of the above embodiments, the third lock is configured to hold the cannula in the deployed configuration and connected to the device.

[0023] In any of the above embodiments, the device is an infusion pump.

[0024] In any of the above embodiments, the support collar is configured to be inserted into and seal the opening formed in the chamber in the deployed configuration. In some embodiments, the cannula is connected to and extends from the support collar. In some embodiments, a second septum is connected to the support collar and a proximal portion of the cannula.

[0025] In any of the above embodiments, a second septum is connected to the support collar and a proximal portion of the cannula.

[0026] In any of the above embodiments, the support collar is distal from the opening when the support collar and the cannula are in the undeployed configuration.

[0027] In any of the above embodiments, in the undeployed configuration, the cannula extends a first length through the first septum.

[0028] In any of the above embodiments, in the deployed configuration, the cannula extends a second length through the first septum that is greater than the first length.

[0029] In any of the above embodiments, a hole is formed on one side of the cannula. In some embodiments, the hole is configured to be in fluid communication with the chamber when the cannula is in the deployed configuration.

[0030] In any of the above embodiments, the locking member holds the support collar and the cannula in the deployed configuration.

[0031] In any of the above embodiments, a seal is disposed between the support collar and the opening.

[0032] In any of the above embodiments, sealing the second portion of the chamber includes inserting the support collar connecting the cannula and the second septum into the opening formed in the second portion of the chamber.

[0033] In any of the above embodiments, the method includes retracting the needle inserter through the first septum and the second septum while the cannula is held in the deployed configuration.

[0034] In any of the above embodiments, the method includes deploying the cannula into the surface at an angle between about 20° and 90° relative to the surface.

[0035] In any of the above embodiments, the method includes locking the second septum in place to maintain the seal of the second portion of the chamber.

[0036] In any of the above embodiments, the first septum is pre-pierced by the cannula and the needle inserter prior to deployment.

[0037] In any of the above embodiments, the chamber is configured to buffer a flow of liquid provided by one or more reservoirs.

[0038] In any of the above embodiments, the cannula is configured to be deployed during use at an angle between about 20° and 90° relative to a portion of the subject's skin below the infusion pump.

[0039] It should be understood that the foregoing concepts, and additional concepts discussed below, can be arranged in any suitable combination, as the claimed application is not limited in this respect. Moreover, other advantages and novel features of the present disclosure can become apparent to those skilled in the art from the following detailed description, when considered in conjunction with the drawings. BRIEF DESCRIPTION OF DRAWINGS

[0040] The drawings are not intended to be to scale. In the drawings, each identical, or nearly identical, component that is illustrated in various figures is represented with a like numeral for clarity. Not all of the components of every aspect of the application are called out in every illustration. In the drawings:

[0041] Figure 1 is a perspective view of one embodiment of a system including an infusion pump and a cannula system attached to the infusion pump;

[0042] Figure 2 is a perspective view of one embodiment of a system including an infusion pump and a cannula system attached to the infusion pump; Figure 1

[0043] Figure 3 is a perspective exploded view of one embodiment of an actuator and latch disposed within a cannula system;

[0044] Figure 4 is a perspective exploded view of one embodiment of a driver and related components of a cannula system;

[0045] Figure 5 is a cross-sectional view of one embodiment of a needle inserter and related spring in a pre-loaded, compressed configuration;

[0046] Figure 6 is a perspective view of one embodiment of a needle inserter and related spring in a pre-loaded, compressed configuration;

[0047] Figure 7 is a perspective view of one embodiment of a cannula;

[0048] Figure 8 is a cross-sectional view of one embodiment of a receiver configured to receive a cannula;

[0049] Figure 9 is a cross-sectional view of one embodiment of a receiver configured to receive a cannula;

[0050] Figure 10 is a perspective view of one embodiment of a system including a cannula system and a connected infusion pump in an attached configuration;

[0051] Figure 11 is a perspective view of one embodiment of a system including a cannula system and a connected infusion pump in an attached configuration; Figure 10

[0052] Figure 12A is a perspective view of one embodiment of a cannula system and infusion pump in a pre-deployment configuration;

[0053] Figure 12B is a close-up perspective view of one embodiment of a system including a cannula system and a connected infusion pump in an attached configuration; Figure 12A

[0054] is a cross-sectional view of one embodiment of a system including a cannula system and a connected infusion pump in an attached configuration; Figure 12C Figure 12A

[0055] ​​​​Figure 13 is a cross-sectional view of one embodiment of a cannula system and infusion pump with a needle inserter partially deployed;

[0056] Figure 14 is a cross-sectional view of one embodiment of an actuation button and associated retainer configured to selectively actuate a cannula system.

[0057] Figure 15 is a cross-sectional view of one embodiment of a cannula system with a needle inserter and a cannula in a deployed configuration;

[0058] Figure 16 is a cross-sectional view of one embodiment of a retraction mechanism of a cannula system after deployment of a cannula;

[0059] Figures 17A-17C depicts one embodiment of a cannula system and infusion pump with a cannula and needle inserter in a deployed configuration;

[0060] Figures 18A-18B depicts one embodiment of an infusion pump after removal of a cannula system and associated needle inserter;

[0061] Figure 19 depicts one embodiment of a system including a cannula system and associated disposable module;

[0062] Figure 20 depicts one embodiment of an infusion pump with a selectively connectable electronics module; and

[0063] Figure 21 depicts an infusion pump and connectable electronics module in an assembled configuration. Figure 20 DETAILED DESCRIPTION

[0064] Typical cannula systems for use with infusion pumps and other devices often require a user to assemble, attach, actuate, and subsequently release various components of the device separately during the cannulation process. The inventors have recognized that these types of operations are lengthy, can lead to user error, and can result in increased operational difficulty when a user applies such systems.

[0065] ​In view of the above, the inventors have recognized benefits associated with systems including cannulation systems that simultaneously release a device and deploy a cannula of the device into a user's tissue upon user actuation of the cannulation system. For example, a user can actuate a trigger of the cannulation system, which can release a needle inserter of the cannulation system, and actuate a lock of the cannulation system to release an associated device, which can be an infusion pump. Such systems can simplify user operation while also helping to avoid errors in the process of deploying a cannula into tissue. Related methods and configurations are described in further detail below. However, as the present disclosure is not limited in this manner, embodiments are also contemplated in which the various systems and devices described herein are operated without simultaneous deployment of a cannula and release of an associated device.

[0066] Turning to the drawings, particular non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described in relation to these embodiments can be used individually and / or in any desired combination, as the present disclosure is not limited to only the specific embodiments described herein.

[0067] Figure 1 and Figure 2 One embodiment of a system is depicted that includes a disposable module 10 in the form of an infusion pump that can be attached to and subsequently released from a cannulation system 20 during a cannula deployment operation. As will be described in further detail below. In some embodiments, the cannulation system and disposable module can include aligned fill ports to facilitate filling of the disposable module with one or more therapeutic compounds for subsequent deployment into a user's tissue.

[0068] In some embodiments, the cannulation system can include 11 individual components and 3 main subassemblies. The elements of the cannulation system can include a base subassembly with left and right latches, an actuator, and a base, and a cover subassembly including a cannula subassembly, a needle inserter, a driver, a retainer, an insertion spring, a retraction spring, and a top. Various embodiments of these different components are described in further detail below.

[0069] As shown in Figure 3 The base assembly 30 can include three main components in the form of two latches 31, a button or actuator 32, and a base 33. In some embodiments, the latches 31 and button 32 can be press-fit into the base 33. This subassembly 30 can latch onto a receiver on a disposable module of an infusion pump and provide alignment for a cannula stroke and an engagement for a user to deploy a cannula into subcutaneous tissue.

[0070] Figure 4One embodiment of the cover subassembly 40 is depicted. In the depicted embodiment, the cover subassembly 40 includes two springs 41, 42 (one spring 41 for insertion, and one spring 42 for retraction of the needle inserter), a needle inserter 43, a driver 44, a retainer 45, a cover 46, and a cannula subassembly. The construction of the cover subassembly 40 can be considered independent of the cannula subassembly, which can be introduced at any point during the cover assembly process.

[0071] As shown in Figure 5 and Figure 6 In one embodiment of the cover subassembly 40, the cannula system can include two compression springs to introduce the cannula and needle inserter into the subcutaneous tissue (insertion spring 41) and to retract the needle inserter from the tissue once the cannula has been locked in the receiver (retraction spring 42), respectively. The springs 41, 42 can be preloaded during storage and only release energy when the user presses the actuator or button. As shown below, prior to deployment, the needle inserter 43 and retraction spring 42 are housed inside the driver 44. The tight fit between the cover 46 and the driver 44 can prevent the arms of the driver from opening and allow the compressed retraction spring 42 to expand. During assembly, the driver 44, retraction spring 42, and needle inserter 43 are slid into the cover 46 and can be pushed towards the top of the cover 46 to preload the insertion spring 41. Once the insertion spring 41 is fully compressed to its pre-deployment position, the retainer 45 is snapped into place to lock the driver 44 in the pre-deployment position. Finally, the cannula subassembly 47 can be slid into place.

[0072] Figure 7One embodiment of a cannula 50 is depicted, which includes three parts: a tube 51, a support post 52, and a septum 53. The polymeric tube 51 begins as an extruded small diameter, thin walled tube with an inner diameter for accommodating a needle that will guide and provide support for the cannula 50 as it penetrates the skin of a subject and / or a septum of an infusion pump or other device. The tube 51 of the cannula can be cut to the appropriate length and subjected to a bevel and flange process (a heat forming process) that can optimize the geometry of the tube for skin puncture and attachment to the support structure, respectively. The tube 51 of the cannula can also include a side port 54 in the form of an opening that is cut (e.g., laser ablated) or otherwise formed in a portion of a side of the cannula 50 in an area that is in fluid communication with one or more reservoirs of an infusion pump in a deployed position. Thus, the cannula 50 can provide a flow path from the infusion pump to the subcutaneous tissue of a subject for flowing an active pharmaceutical ingredient (API) or other therapeutic compound to the tissue of the subject. In embodiments that include a support, such as the depicted support post, the support can be an injection molded polymeric structure (typically a thermoplastic that can be bonded to the tube), although other manufacturing methods and materials can be used. The support post 52 can be bonded to the tube 51 and can be configured to establish two seals, including a first seal with the flanged side of the cannula and a second seal with an open port of an infusion pump against which the support post is pressed in a deployed configuration. The septum 53 of the cannula can be accommodated by the support post 52 and can be made of a medical grade silicone or other suitable elastomeric or elastomer material that can seal the cannula 50. Thus, the septum of the cannula can enable the use of a needle inserter during deployment of the cannula without leakage after deployment.

[0073] Figure 8 and Figure 9An embodiment of a receiving structure is depicted that includes an outlet 25 of an infusion pump configured to receive a cannula 50 during deployment of the cannula into tissue. The depicted outlet includes five pieces: a receiving piece 26, a receiving piece septum 27, a dispenser 28, a base 29, and a base septum 24. The outlet 25 is heat sealed to the microfluidic laminate 19 and is mechanically sealed to the cannula 50. Initially, the injection molded dispenser 28 and base 29 can compress the base septum 24. This compression can be permanent by laminating the dispenser 28 and base 29 to the microfluidic laminate 19. Separately, the receiving piece septum 27 can be seated in the dispenser 28 and the receiving piece 26 can be attached to the base 29 in a ultrasonic weld or otherwise, which can fix a desired compression level of the receiving piece septum 27 and alignment of all components of the inserter, including the cannula 50, to the outlet 25. In some embodiments, the receiving piece septum 27 is not intended to be penetrated, but rather behaves more like an o-ring when pressed against the support post, and thus the receiving piece septum 27 can also be referred to as a seal in some embodiments.

[0074] Once the device is fully assembled, the inserter base can be locked onto the receiving piece 26 by snapping the latch into place with one or more posts 22, notches, or other mechanical interlocking features located on the receiving piece 26, see Figures 10-11 . This can provide alignment for the inserter cover to slide into place with the aid of alignment features on the inserter base, see Figures 12A-12C .

[0075] Still referring to Figures 12A-12C , once full assembly is complete, the deployment system remains securely attached to the disposable device 10 by engagement of the latch on the receiving piece 26. The pre-deployed cannula 50 can be pre-positioned 1 mm to 1.5 mm or any other suitable distance from the skin. The needle inserter 43, typically a stainless steel cannula, is seated within the cannula 50. The cannula 50 and needle inserter 43 penetrate the base septum 24. By having the cannula and needle inserter in this position prior to deployment, penetration of the cannula septum and the base septum can be controlled during the manufacturing process of the device, but it is also contemplated that the needle inserter does not pre-penetrate the device septum. In the depicted pre-deployed configuration, there is no seal between the support post 52 and the receiving piece septum 27, which can help facilitate the filling process of the device by allowing air to move from the inlet of the fluid path toward the outlet of the fluid path.

[0076] During actuation of the deployment system, the inserter drives the cannula 50 and needle inserter 43 into the tissue. From the user's perspective, the insertion cycle can appear instantaneous. However, in some embodiments, three distinct deployment phases can occur during operation once the user presses the actuator.

[0077] As shown in Figures 13-14 , in one embodiment, the first deployment phase can primarily include release of the retainer 45. During this initial phase, the user overcomes a critical force to disengage the retainer from the applicator cover. When the retainer 45 opens, the pre-loaded insertion spring 41 will convert its potential energy into kinetic energy, which will push the driver 44, needle inserter 43, cannula subassembly, and release spring 42 towards the skin (see Figure 4 for more details). The impulsive force exerted from the insertion spring 41 onto the driver 44 can be large enough to provide enough momentum to overcome any restraining forces applied to the driver 44 and cannula 50 from the latch and receiver snap points.

[0078] During the second phase, the cannula can be locked into its final deployment position, and the deployment system can release the infusion pump, see Figures 15-16 . In this phase, the hydraulic pathway between the reservoir and the subcutaneous tissue is complete. The driver 44 is no longer radially restrained by the applicator cover 46 and will allow the potential energy from the retraction spring 42 to be released. In the deployed configuration, the support post 52 is radially compressed against the diaphragm 27 of the receiver in the form of a seal extending around the perimeter of the support collar, sealing the associated opening. The seal can be permanent by using a latch mechanism that prevents the support post from shifting relative to the receiver. In this state, the outlet is completely sealed and there is no fluid path for the therapeutic compound to enter the tissue, even if the cannula is in its final position.

[0079] During the final third phase of deployment, the retraction spring, which is pre-loaded seated within the driver prior to cannula deployment (see Figure 5 ), can freely move the needle inserter 43 in the opposite direction along the insertion plane towards the cover of the applicator, see Figures 17A-17C . This removes the needle inserter 43 from within the deployed cannula, while the cannula 50 remains locked in the deployed configuration due to the cannula support being locked to the receiver 26 of the infusion pump. In its final position, the pointed tip of the needle inserter can be hidden within the driver 44, protecting the user from accidental puncture when operating the deployment system, see Figures 18A-18B .

[0080] During operation of the infusion pump to deliver a therapeutic compound to the tissue of a subject, a needle retraction process occurs and there is an unobstructed path from the microfluidic laminate, through the dispenser which dispenses the liquid containing the therapeutic compound, through the side port on the cannula, and through the cannula to the distal end of the cannula deployed into the tissue of the subject. As shown in the drawings, the cannula septum seals the needle track left by the needle inserter while providing a flow path from the one or more reservoirs of the infusion pump to the tissue.

[0081] In some embodiments, the cannula deployment system can include a mobile infusion pump 10 that can be attached to the skin of a user for subcutaneous delivery of a therapeutic compound. As depicted in Figures 19-21 the system can include a disposable module 10 or cassette, a reusable electronics module 60, a cannula system 20, and a controller 70. The disposable module 10 can include a fluid path for the therapeutic compound and one or more actuators, such as electrochemical actuators, that will drive the therapeutic compound into the tissue. The base of the disposable module 10 can be attached with a breathable adhesive to secure the device to the skin of a user. The disposable module 10 can include an electrical connector that selectively receives and engages with the reusable electronics module 60.

[0082] In the depicted embodiment, most of the components of the integrated circuit can be housed in the reusable electronics module 60. The module 60 can interface with the one or more actuators contained within the disposable module 10 and a separate controller, which in the depicted embodiment is a handheld computing device such as a tablet or smartphone, but any other suitable computing device including a stationary computer can be used as the disclosure is not limited in this manner. The processor of the reusable electronics module 60 can be programmed from the user interface of the controller 70. The processor of the reusable electronics module 60 can also be configured to collect data that can later be uploaded to the controller 70. The controller 70 can be configured to present a user interface for controlling the operation of the infusion pump 10. Through the user interface, the user and / or caregiver can establish dose parameters and access data sent back through the reusable electronics module.

[0083] Example: Example Operation

[0084] Prior to use of the device, the user or caregiver can input a dosing schedule for the pump through the controller. Operation of the device can include the following steps:

[0085] 1. The user opens a new package with a disposable module and pre-assembled cannula system;

[0086] 2. The user connects the reusable electronics module to the disposable module;

[0087] 3. The controller and reusable electronics module can signal that the device is ready to be primed;

[0088] 4. The user primes the device through a port on the cannula system;

[0089] 5. The user visually confirms that the device has been properly primed;

[0090] 6. The user removes the adhesive liner and adheres the device to the desired area of skin for delivery;

[0091] 7. The user presses the button on the cannula system and detaches the cannula system from the patch pump;

[0092] 8. The user confirms on the user interface of the controller that the cannula was successful and the dosing schedule begins;

[0093] 9. At the start of the dosing schedule, the reusable electronics module and disposable module can complete a full circuit that controls the operation of the pump, senses changes in the behavior of the pump and alerts the user of any issues with the device; and

[0094] 10. The dose delivered by the infusion pump can be controlled by a circuit design that precisely regulates the level of current that flows through any set of electrodes within the electrolytic chamber and the duration of this electrical signal, typically a square wave. A compensation algorithm is used to account for potential changes in the volume of gas within each electrolytic engine due to changes in atmospheric conditions (temperature and pressure).

[0095] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents. Therefore, the foregoing description and drawings are by way of example only.

Claims

1. A system comprising: An infusion pump that includes a cannula; as well as A cannula inserter, wherein the infusion pump is initially connected to the cannula inserter; The cannula inserter is configured to hold the infusion pump prior to actuation, and the cannula inserter includes: A first locking element, configured to connect the infusion pump to the cannula inserter; An inserter needle configured to move between an undeployed configuration and a deployed configuration; A second locking element, configured to retain the inserter pin in the undeployed configuration; and A trigger, wherein actuation of the trigger is configured to unlock the first locking element to allow the inserter needle to move from the undeployed configuration to the deployed configuration, and to unlock the second locking element to release the infusion pump. In the non-deployed configuration, the cannula inserter is configured to deploy the cannula of the infusion pump through the first diaphragm of the infusion pump. The cannula inserter is configured to release the infusion pump during actuation.

2. The system according to claim 1, wherein, The infusion pump further includes a second diaphragm, wherein the cannula is connected to and extends from the second diaphragm, and wherein the second diaphragm is configured to seal at least a portion of the chamber of the infusion pump when the cannula is in a deployment configuration.

3. The system according to claim 2, wherein, The movement of the inserter needle of the cannula inserter toward the deployment configuration releases the infusion pump from the cannula inserter.

4. The system according to claim 1, wherein, The movement of the inserter pin from the undeployed configuration to the deployed configuration unlocks the second locking element.

5. The system according to claim 1, wherein, The first locking element includes two opposing latches configured to engage with corresponding portions of the infusion pump to connect the infusion pump to the cannula inserter.

6. The system according to claim 5, wherein, The movement of the inserter needle from the undeployed configuration to the deployed configuration causes the two opposing latches to disengage from the corresponding portions of the infusion pump, thereby releasing the infusion pump.

7. The system of claim 1, wherein the cannula inserter further comprises a third locking member configured to retain the cannula in the deployment configuration and connect it to the infusion pump.

8. The system according to claim 1, wherein, The infusion pump also includes: A chamber, the chamber being in fluid communication with one or more reservoirs; A first diaphragm, the first diaphragm being configured to seal a first portion of the chamber; A second diaphragm, the second diaphragm being configured to seal a second portion of the chamber; and The cannula is connected to and extends from the second diaphragm into the interior of the chamber, and wherein, when the cannula is deployed by the cannula inserter coupled to the infusion pump, the cannula extends through the first diaphragm to the exterior of the infusion pump.

9. The system of claim 8, wherein the infusion pump further comprises a support collar configured to insert into an opening formed in the chamber in a deployment configuration and to seal relative to the opening, wherein, The cannula is connected to and extends from the support collar, wherein the second diaphragm is connected to the support collar and the proximal portion of the cannula.

10. The system according to claim 1, wherein the infusion pump further comprises: A chamber, the chamber being in fluid communication with one or more reservoirs; A first diaphragm, the first diaphragm being configured to seal a first portion of the chamber; An opening is formed in the second part of the chamber; A support collar configured to be inserted into the opening in a deployment configuration and to seal relative to the opening; as well as A cannula connected to and extending from the support collar, wherein the cannula is configured to extend through the first diaphragm to the outside of the infusion pump in the deployment configuration.

11. The system of claim 10, wherein the infusion pump further comprises a second diaphragm connected to the support collar and the proximal portion of the cannula.

12. The system according to claim 10, wherein, When the support collar and the cannula are in an undeployed configuration, the support collar is away from the opening.

13. The system according to claim 10, wherein, In the undeployed configuration, the cannula extends a first length through the first diaphragm.

14. The system according to claim 13, wherein, In the deployment configuration, the cannula extends a second length through the first diaphragm, the second length being greater than the first length.

15. The system of claim 10, wherein the infusion pump further comprises a hole formed in one side of the cannula, wherein, The orifice is configured to be in fluid communication with the chamber when the cannula is in the deployment configuration.

16. The system of claim 10, wherein the infusion pump further comprises a locking element that retains the support collar and the cannula in the deployment configuration.

17. The system of claim 10, wherein the infusion pump further comprises a seal disposed between the support collar and the opening.

Images