Systems and devices for infusing into the body

Abstract

Embodiments of the present application are directed to systems, devices, and methods for diabetes management. In particular, the present disclosure relates to devices and methods for dispensing insulin to a patient. A portable fluid infusion device is disclosed that includes a disposable part (DP) and a reusable part (RP). The DP includes a first reservoir and a second reservoir that is less than or equal to the first reservoir in length, and the RP includes a first compartment configured to receive the first reservoir, a second compartment configured to receive the second reservoir, and a gasket for sealing the junction between the second reservoir and the second compartment when the RP and DP are connected.

Description

[0001] This application is a divisional application of application number 201910043026.7, filed on May 5, 2016, entitled "System and apparatus for infusing fluid into the body". Technical Field

[0002] Embodiments of this disclosure relate to systems, devices, and methods for diabetes management. Specifically, this disclosure relates to devices and methods for dispensing insulin to a patient. More specifically, this disclosure relates to miniature, portable, skin-attached insulin patch pumps. Background Technology

[0003] People with diabetes need to administer varying amounts of insulin throughout the day to control their blood sugar levels. Portable insulin infusion pumps are an excellent option for multiple daily insulin injections. However, while these devices offer improvements in multiple daily injections, they also suffer from some drawbacks. One drawback is the size and weight of the devices due to the construction and relatively large size of the drive mechanism and syringe. These relatively bulky devices must be carried regularly in the patient's pocket or attached to his / her belt. Summary of the Invention

[0004] Embodiments of this disclosure pertain to a diabetes management system including a miniature insulin patch pump. The patch pump can be controlled by any electronic device (“bridging” device) with an RF communication device such as Bluetooth or Bluetooth Low Energy (BLE). Software including patient and pump control parameters can be stored on a remote server and can be downloaded to the bridging device upon receiving user authentication. The bridging device provides bidirectional communication between the patch pump and a remote workstation (such as a physician’s office PC or remote smartphone for a parent of a child with diabetes). The patch pump can be integrated into a diabetes management system including a continuous glucose monitor (CGM) and a blood glucose monitor (BGM). An artificial pancreas algorithm on the patch pump processor automatically controls insulin delivery based on continuous glucose readings received from the remote CGM (“closed-loop system”). The bridging device processor includes dose calculator software that calculates and recommends a single dose. The single dose is calculated by the bridging processor after receiving blood glucose readings from the remote BGM, glucose level trends from the remote CGM, and dietary carbohydrate content from the bridging user interface (i.e., a touchscreen). The patch pump can continuously deliver insulin based on CGM glucose readings; receive dose commands from a bridging device during meals; or both. The patch pump may include: 1) a reusable component (RP), which may include one or more of a battery, an actuation module with a drive lever (“lever”), and an electronics module; 2) a disposable component (DP), which may include one or more of a first reservoir, a second reservoir (“drug dispenser”), and a discharge port; 3) a disposable tray / cannula / insertter assembly; and 4) a charger. After filling the reservoir, connecting the RP and DP, and purging (perfusion), the patch pump is ready for insulin delivery. After cannula insertion and tray adhesion to the skin, the patch can be attached to the tray and can be disconnected and reconnected as desired by the patient. When the patch pump is disconnected, the reservoir can be refilled and the RP can be replaced by a second RP with a rechargeable battery. The pumping mechanism may include a first reservoir with a first plunger, a second reservoir (drug dispenser) with a second plunger, a first conduit connecting the first and second reservoirs, a second conduit connecting the second reservoir and a discharge port, and a discharge port. The second reservoir can be linearly displaced relative to the first reservoir due to the linear displacement of the second plunger under the action of the actuation module and the drive rod. When the second plunger displaces in one direction, the second reservoir displaces linearly in the same first direction, and fluid is transported from the first reservoir to the second reservoir via the first conduit. When the second plunger displaces in the opposite direction, the second reservoir displaces in the same opposite direction, and fluid is transported from the second reservoir to the discharge port via the second conduit.

[0005] Some advantages of embodiments of this disclosure include miniaturization of the device (e.g., easy portability), its accuracy, and ease of integration. For example, the device and system have the ability to integrate with closed-loop and open-loop diabetes management systems. Additionally, they can be utilized for a much longer duration compared to conventional systems. Furthermore, this embodiment discloses methods for removing air bubbles from fluids, features that distinguish these characteristics from conventional methods and systems. In some embodiments, a portable device comprising an insulin reservoir communicating with a subcutaneous cannula and a method for continuous (basal) and on-demand (dosage) insulin delivery are disclosed. Basal and dose dosing rates contribute to improved accuracy of insulin delivery. In some embodiments, a mobile, skin-adhesive insulin pump (patch pump) that is significantly smaller, less bulky, thinner, and lighter than previously known insulin delivery systems is disclosed. Additionally, the skin-adhesive patch pump can be concealed. In some embodiments, the device may be without operating buttons and can be remotely controlled. In some embodiments, the patch pump includes reusable and disposable components. Reusable components may include most or all of the relatively expensive components, including a plunger threaded rod, battery, transmission mechanism, and electronics. Additionally, the patch pump can be waterproof and achieves pressure equalization between the surrounding environment and the reservoir. Furthermore, the patch pump can be controlled using various consumer electronic devices that patients can use, such as smartphones, smartwatches, tablets, or PCs.

[0006] In some embodiments, a portable fluid delivery device includes: a first reservoir; a second reservoir including a plunger and a hollow needle configured to allow fluid to flow into and / or out of the second reservoir; a dual-chamber assembly including a first chamber compartment and a second chamber compartment; a discharge port; a first conduit configured to exchange fluid between the first reservoir and the first chamber compartment of the dual-chamber assembly; and a second conduit configured to exchange fluid between the discharge port and the second chamber compartment of the dual-chamber assembly; wherein the tip or opening of the hollow needle is configured to transfer from the second chamber compartment to the first chamber compartment when the second reservoir is displaced in a first direction, and to transfer from the first chamber compartment to the second chamber compartment when the second reservoir is displaced in a direction opposite to the first direction.

[0007] In some embodiments, the first reservoir further includes a filling port for receiving fluid into the first reservoir. The first reservoir may also be configured as a pre-filled, replaceable reservoir. Additionally, the first reservoir includes a second plunger configured to move between the two ends of the first reservoir in the first direction and / or in a direction opposite to the first direction, wherein the advancement of the second plunger in the direction opposite to the first direction causes fluid in the first reservoir to flow into the second reservoir.

[0008] In some embodiments, the portable fluid delivery device further includes an electronic module and an actuation module for operating the plunger to move in a first direction and / or opposite to the first direction. The electronic module includes a power supply, a processor, a transceiver, a buzzer, and / or sensors, wherein the sensors include one or more of a motion sensor, a power sensor, a bubble sensor, a speed sensor, a blockage sensor, a reservoir level sensor, a second reservoir motion sensor, a second reservoir position sensor, and / or a plunger position sensor. Additionally, the actuation module includes an actuator and a lever configured to functionally connect with the plunger to drive the displacement of the plunger and / or the second reservoir. The actuation module further includes a rod coupling device connected to the rod and a plunger coupling device connected to the plunger; wherein the connection between the rod coupling device and the plunger coupling device allows the rod to be functionally coupled to the plunger; wherein the connection between the rod coupling device and the plunger coupling device is mechanical and / or magnetic; wherein, when the plunger is displaced to its maximum extent in a first direction, the distal end of the first reservoir is aligned with or extends beyond the distal end of the rod.

[0009] In some embodiments, the portable fluid delivery device further includes a first stop configured to block the proximal end of the second reservoir when the second reservoir is displaced in the first direction; and a second stop configured to block the proximal end of the second reservoir when the second reservoir is displaced in a direction opposite to the first direction. In some embodiments, the hollow needle is rigidly coupled to the second reservoir. In some embodiments, displacement of the plunger in the first direction is configured to cause fluid to flow from the first reservoir through the first conduit to the first chamber compartment, and displacement of the plunger in the opposite direction is configured to cause fluid to flow from the second reservoir through the second conduit to the discharge port, wherein the plunger and the second reservoir are functionally coupled to cause the second reservoir to displace in the same direction as the displacement direction of the plunger until one of the first stop and the second stop blocks the second reservoir.

[0010] In some embodiments, the portable fluid delivery device includes: a disposable component (DP) including a first reservoir and a second reservoir, the second reservoir having a length less than or equal to the length of the first reservoir; and a reusable component (RP) including: a first compartment configured to receive the first reservoir; a second compartment configured to receive the second reservoir; and a gasket for sealing the joint between the second reservoir and the second compartment when the RP and the DP are connected. Additionally, the portable fluid delivery device includes a vent configured to vent the first compartment, wherein the vent includes an orifice disposed on the device for venting the first compartment. Furthermore, the vent may be configured to operate when the RP and the DP are connected. In some embodiments, after the RP and the DP are connected, the second compartment is sealed and the first compartment is vented.

[0011] In some embodiments, the RP includes a rigid housing, wherein, after the RP and the DP are connected, at least one of the first and second reservoirs does not contact the housing. In some embodiments, after the RP and the DP are connected, the first and second reservoirs do not contact the housing. In some embodiments, the portable fluid delivery device further includes a waterproof member disposed between the RP and the DP and configured to allow air to pass through the member and substantially restrict or prevent the passage of liquid, wherein the first compartment includes a non-circular opening for allowing the first reservoir to be received into the first compartment and / or the second compartment includes a circular opening for allowing the second reservoir to be received into the second compartment. In some embodiments, the maximum height of the second reservoir is approximately equal to the maximum height of the first reservoir. In some embodiments, the first reservoir includes a filling port for receiving fluid into the first reservoir, wherein the filling port includes an opening pierced from a silicone diaphragm of the housing of the first reservoir. In some embodiments, the first reservoir is configured as a pre-filled, replaceable reservoir.

[0012] It should be understood that all combinations of the above and additional concepts discussed in more detail below (assuming these concepts are not contradictory) are considered part of the inventive subject matter disclosed herein. In particular, all combinations of the claimed subject matter appearing at the end of this disclosure are considered part of the inventive subject matter disclosed herein. It should also be understood that terms expressly used herein, and which may also appear in any disclosure incorporated by reference, shall be given the meaning most consistent with the specific concept disclosed herein. Attached Figure Description

[0013] Those skilled in the art will understand that the accompanying drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily drawn to scale; in some cases, aspects of the inventive subject matter disclosed herein may be exaggerated or enlarged in the drawings to aid in understanding different features. In the drawings, the same reference numerals generally refer to the same features (e.g., functionally similar and / or structurally similar elements).

[0014] Figure 1 The present invention illustrates some embodiments of a diabetes management system.

[0015] Figures 2A to 2B illustrate the interfaces of infusion devices and infusion sites in some embodiments.

[0016] Figure 3 A spatial view of an infusion device according to some embodiments is shown.

[0017] Figures 4A and 4B show spatial views of reusable components (RP) and disposable components (DP) in some embodiments.

[0018] Figures 5A and 5B show spatial views before and after the connection of reusable and disposable components according to some embodiments.

[0019] Figure 6 Schemes for reusable components are shown in some embodiments.

[0020] Figure 7 Spatial cross-sectional views of reusable components in some embodiments are shown.

[0021] Figure 8 Example schemes of disposable components are shown in some embodiments.

[0022] Figure 9 Spatial cross-sectional views of disposable components from some embodiments are shown.

[0023] Figure 10 A cross-sectional view of a disposable component base is shown in some embodiments.

[0024] Figure 11 Some embodiments of infusion pumps are shown.

[0025] Figure 12 Spatial cross-sectional views of reusable and disposable components before and after connection are shown in some embodiments.

[0026] Figure 13 The embodiments of the actuation module are shown.

[0027] Figure 14 Spatial views of electronic modules and actuation modules of some embodiments are shown.

[0028] Figures 15A to F illustrate some embodiments of the pumping mechanism.

[0029] Figures 16A to 16B illustrate some embodiments of the pumping mechanism.

[0030] Figures 17A and 17B show top and sectional views of bracket schemes for some embodiments.

[0031] Figures 18A and 18B show spatial views of the bracket before (A) and after (B) cannula insertion in some embodiments.

[0032] Figures 19A to C illustrate some embodiments of infusion site interfaces (e.g., inserters, brackets, and cannulas) and insertion mechanisms.

[0033] Figures 20A to D show spatial views of infusion site interfaces (e.g., inserters, brackets, and cannulas) and insertion mechanisms in some embodiments.

[0034] Figures 21A to F schematically show top views of the equipment preparation for operation in some embodiments.

[0035] Figures 22A to D illustrate some embodiments of the infusion treatment scheme.

[0036] Figures 23A to C illustrate methods for battery replacement and reservoir refilling in some embodiments.

[0037] Figures 24A to F illustrate some embodiments of methods for extending the duration of device use.

[0038] Figure 25 The presents some embodiments of active valve systems.

[0039] Figure 25 Figures A and 26A to B show scaled-up versions of some embodiments of the active valve system.

[0040] Figures 27A to F illustrate some embodiments of pumping mechanisms employing active valve systems.

[0041] Figures 28A and B show enlarged cross-sectional views (B) of some embodiments including an active valve system.

[0042] Figures 29A to C show cross-sectional views (A and B) and spatial views (C) of the active valve system of Figure 28 in some embodiments.

[0043] Figures 30A to B illustrate some embodiments of active valve systems.

[0044] Figure 31 The diagram illustrates some embodiments of pump electronics modules and actuation modules.

[0045] Figure 32 A longitudinal sectional view of the device is shown for some embodiments.

[0046] Figures 33A to 33B illustrate some embodiments of magnetically reversible (A) and mechanically reversible (B) connections for a drive screw with a dosing plunger.

[0047] Figure 34 The presents a scheme of motor operation modes during various stages of plunger movement and fluid distribution, illustrating some embodiments.

[0048] Figures 35A to B illustrate some embodiments of the procedures a patient should take when receiving a blockage warning.

[0049] Figures 36A to B illustrate some embodiments of the storage sensor end design.

[0050] Figure 37 A block diagram of a diabetes management system according to some embodiments is shown.

[0051] Figure 38 Block diagrams of insulin management systems according to some embodiments are shown.

[0052] Figures 39A to D show examples of bridging devices according to some embodiments.

[0053] Figure 40 A schematic diagram of a server in some embodiments is shown.

[0054] Figure 41 Schematic diagrams of bridging devices according to some embodiments are shown. Detailed Implementation

[0055] Reference Figure 1In some embodiments, a scheme for a diabetes management system 100 is shown. The system includes at least one of the following components: an insulin pump 1, a continuous glucose monitor (CGM) 300, a blood glucose monitor (BGM) 400, a controller 200, a smartphone 500, a PC 600, and a cloud 700. The components of system 100 can communicate wirelessly using bidirectional communication (i.e., pump 1 to controller 200) or one-way communication (i.e., pump 1 to smartphone 500). The communication protocol can be, for example, Bluetooth, Bluetooth Low Energy (BLE), or any other proprietary RF protocol. The pump controller 200 provides an interface between the user and pump 1 for controlling basal and single-dose administration and for receiving warnings and alarms. Communication between the CGM 300 and pump 1 provides an artificial pancreas (closed-loop system) function, in which insulin doses are automatically administered based on glucose levels monitored by the CGM 300. Glucose readings for calculating insulin dosage are provided to the user by transmitting readings from BGM 400 and / or CGM 300 to pump controller 200 and / or smartphone 500. Real-time stored data from pump 1, pump controller 200, CGM 300, and BGM 400 can be transmitted to smartphone 500 for presentation or storage. Two-way cellular communication between smartphone 500 and cloud 700 provides the patient with the ability to download personal data stored on a remote server. Data in cloud 700 can be downloaded, processed, and transmitted from PC 600 or remote smartphone 800, or vice versa. Example 1) Real-time transmission of glucose readings measured with a child's BGM 400 to the mother's smartphone 800. Example 2) A physician downloads data stored from the previous month from cloud 700 to the office PC 600 (insulin administration and glucose readings). Therefore, the physician makes adjustments to accommodate the basic profile settings and sends the message to the patient's smartphone 500.

[0056] Referring to Figures 2A to 2B, in some embodiments, arrangements of an infusion device 1 (2a) (hereinafter referred to as the "device") and an infusion site interface 10 (2b) are shown. In some embodiments, the device 1 can infuse fluid into a patient via a cannula or needle in direct fluid communication with the device 1, without the need for external tubing. The fluid may be a drug (such as a biologic, hormone, or chemotherapeutic agent). A hormone may be insulin or, for example, glucagon. The device 1 may be configured to deliver fluid according to a predetermined procedure. The device 1 may also be a component of system 100, wherein the device 1 wirelessly communicates with one or more of the components of system 100—BGM, CGM, pump controller, smartphone, or any other designated remote transceiver. Figure 2aDevice 1 is shown. Device 1 may include a reusable component (RP) 2, a disposable component (DP) 3, a bracket 4, and a cannula 9. RP 2 and DP 3 may be reversibly connected to each other to form a functional infusion pump 6. DP 3 may include an outlet 7 through which infusion fluid exits DP 3 and enters the patient's body. Pump 6 may be reversibly connected to bracket 4 via, for example, a snap-fit ​​mechanism 8. One side (e.g., the bottom side) of the bracket may be attached to the patient's body using, for example, an adhesive. Figure 2b An infusion site interface 10 is shown. The infusion site interface 10 includes an inserter 5, a bracket 4, and a cannula 9. The bracket 4 faces the patient's skin and is opposite the inserter 5. When the infusion site interface 10 is attached to the patient's skin, the bracket 4 adheres to the skin via a bracket adhesive. The cannula 9 can be automatically inserted into the patient using the inserter 5 by pressing a button 56. After cannula insertion, the inserter 5 is positioned, the bracket 4 remains adhered to the skin, and the cannula 9 passes through the discharge port 7 and is placed in the subcutaneous tissue beneath the patient's skin.

[0057] Reference Figure 3 In some embodiments, a partial view of device 1 is shown. Device 1 includes a pump 6 containing RP 2 and DP 3, a bracket 4 with a snap-fit ​​8, and a cannula 9. DP includes a filling port 39.

[0058] Referring to Figures 4A to 4B, spatial views of RP 2 and DP 3 are shown in some embodiments. RP 2 includes a rigid housing 44 and two openings—an elliptical opening 30 and a circular opening 28. DP 3 includes a reservoir 32, a dosing device 33, and a filling port 39.

[0059] Referring to Figures 5A and 5B, in some embodiments, spatial views of RP 2 and DP 3 forming pump 6 before and after connection are shown, respectively. The elliptical reservoir 32 and the circular dosing device 33 are aligned with openings 30 and 28, respectively.

[0060] Reference Figure 6 In some embodiments, a configuration of RP 2 is shown. RP 2 includes a housing 44 and a partition 20. The partition 20 divides RP 2 into a first compartment 21 and a second compartment 22. The housing 44 is rigid and may be made of, for example, metal or plastic. The first compartment 21 contains an electronic module 23 and an actuation module 24. The actuation module 24 may include an actuator 25 (i.e., a motor and gears), a rod 26 (i.e., a drive screw), and a rod connection device 27. The first compartment 21 includes an opening 28 having a circular cross-sectional shape and a gasket 29 disposed around the periphery of the opening 29. Whenever RP 2 and DP 3 are connected, the gasket 29 seals the first compartment 21 waterproofly. The second compartment 22 has an opening 30, which may have a non-circular cross-section (such as an elliptical cross-section). When RP 2 and DP 3 are connected, compartment 22 is not sealed.

[0061] Reference Figure 7 In some embodiments, a spatial cross-sectional view of RP 2 is shown. RP 2 includes a rigid housing 44 and a partition 20 dividing RP 2 (dashed line) into a sealed compartment 21 and a non-sealed (“ventilated”) compartment 22. The non-sealed compartment 22 has openings 30 that may be elliptical, circular, or four arcuate in shape. The sealed compartment 21 includes an opening 28 that is circular in shape. Gaskets (not shown) are disposed around the periphery of the opening 28. Compartment 21 may include an electronics unit 23, a motor 49, a gear 50, a rod 26, and a rod connection device 27.

[0062] Reference Figure 8 In some embodiments, one embodiment of DP 3 is shown. DP 3 includes a base 31, a reservoir 32 for storing infusion fluid, a dosing device 33 for accurately administering the stored infusion fluid to a patient, and a discharge port 7. The reservoir 32 and the dosing device 33 may be rigidly connected to the base 31. A first check valve 34 may be disposed in the base 31 between the reservoir 32 and the dosing device 33, such that fluid flow is only allowed from the reservoir 32 to the dosing device 33, but not in the opposite direction. A second check valve 35 may be disposed in the base 31 between the dosing device 33 and the discharge port 7, such that fluid flow is only allowed from the dosing device 33 to the discharge port 7, but not in the opposite direction. The reservoir 32 may include a filling port 39 and a reservoir plunger 36 configured to advance from a first open end 37 of the reservoir 32 to a second closed end 38 of the reservoir 32. The plunger 36 may also advance from the second reservoir end 38 to the first reservoir end 37. The filling port 39 may include a thin diaphragm (i.e., a silicone diaphragm) that can be punctured with a needle and self-resealed upon needle retraction. The dosing device 33 may include a dosing device plunger 40, the dosing device plunger 36 being configured to advance from the first open end 42 of the dosing device 33 to the second end 43 of the dosing device 33. The dosing device plunger 40 may also advance from the second end 43 to the first end 42. The dosing device plunger 40 may be fitted with a plunger coupling device 41. The end-to-end length of the dosing device 33 may be less than the end-to-end length of the reservoir 32. More specifically, the length of the dosing device 33 may be less than or equal to approximately half the length of the reservoir 32. The diameter of the dosing device 33 may be less than 8 mm. More specifically, the diameter of the dosing device 33 may be less than approximately 5 mm.

[0063] Reference Figure 9 In some embodiments, a spatial cross-sectional view of RP 3 is shown. DP 3 includes a base 31, a discharge port 7, a reservoir 32, and a dosing device 33. The reservoir 32 includes a plunger 36 and a filling port 39. The dosing device 33 includes a dosing device plunger 40. The plunger 36 and the dosing device plunger 40 are movable in two directions, respectively, between first (open) ends 37 and 42 and second ends 38 and 43.

[0064] Reference Figure 10 In some embodiments, the DP base 31 is shown along... Figure 8 A cross-sectional view taken from plane AA. The cross-section of the dosing device 33 can be circular, thereby allowing for a watertight seal using the gasket 29 of RP 2. The cross-section of the reservoir 32 can be non-circular, for example, elliptical, oblong, or oval, thereby allowing the reservoir to hold a suitable volume of infusion fluid while keeping the z-dimensional (thickness) of the pump 6 thin. In some embodiments of this disclosure, the pump 6 may be less than 10 mm thick, or even less than 8 mm thick, or even less than 6 mm thick.

[0065] Reference Figure 11 In some embodiments, a scheme for pump 6 is shown. Pump 6 is obtained by reversibly connecting RP 2 and DP 3. Whenever RP 2 and DP 3 are connected to form pump 6, a second reservoir (or "dosing device") 33 is housed within the first compartment 21 of RP 2, and a first reservoir 32 (or "reservoir") is housed within the second compartment 22 of RP 2. A septum 20 provides a completely sealed separation between the two compartments. A gasket 29, which may be located at the opening 28 of RP 2, forms a watertight seal around the dosing device 33, thereby allowing the compartment 21 of pump 6 to be watertight. Thus, water and moisture can be kept away from all components located in compartment 21, including the electronics module 23 and the actuation module 24. The interface 43 between compartment 22 and DP 3 may or may not accommodate a watertight seal. In some embodiments of this disclosure, a semi-permeable seal is provided on interface 43 to prevent dust from entering compartment 22, but allows air to circulate freely between the compartment and the external environment. This allows pressure equalization to be achieved between compartment 22 and the surrounding atmosphere. In another embodiment, pressure equalization can be achieved using a small opening 70 in housing 44. In some embodiments, the reservoir 32 within compartment 22 does not contact housing 44. Therefore, housing 44 protects reservoir 32 from external compression and subsequent accidental release of infusion fluid from reservoir 32. Whenever RP 2 and DP 3 are connected to form pump 6, rod 26 and dosing plunger 40 can be engaged. Engagement can be achieved using a reversible connection between rod coupling 27 and dosing coupling 41. In some embodiments of this disclosure, rod coupling 27 may include a magnet of a specific polarity, and plunger coupling 41 may have the opposite polarity. In some embodiments of this disclosure, couplings 27 and 41 may be a “male-female” engagement mechanism, such as a snap-fit ​​mechanism or any other known engagement mechanism in the art. Once couplings 27 and 41 are engaged, linear movement of rod 26 causes a corresponding linear movement of dosing plunger 40. A detailed description of the coupling mechanism is shown in Figure 33.

[0066] Reference Figure 12In some embodiments, a spatial cross-sectional view of pump 6 is shown after RP 2 and DP 3 are connected. Dosing device 33 and reservoir 32 are respectively housed within a sealed compartment 21 and a ventilated compartment 22 of RP 2. A rigid housing 44 protects dosing device 33 and reservoir 32 from external pressure. A septum 20 provides a completely sealed partition (dashed line) between the two compartments. A gasket 29 achieves the seal of compartment 21. The sealed compartment 21 includes an electronic module 23, a motor 49, a gear 50, a rod 26, and a coupling device 27. After DP 3 and RP 2 are connected, the rod coupling device 27 and the plunger coupling device (not shown) are engaged.

[0067] Reference Figure 13 In some embodiments, an actuation module 24 is shown. The actuation module 24 may include a motor 49, a first gear 50, a rotatable nut (hereinafter, "nut") 51, a rod 26, and a rod connection device 27. The motor 49 may be an electric motor. In some embodiments of this disclosure, the motor 49 may be of the following types: DC motor, general-purpose motor, AC motor, stepper motor, permanent magnet motor, brushed DC motor, brushless DC motor, switched reluctance motor, coreless DC motor, printed armature or flat DC motor, AC motor with sliding rotor, synchronous motor, induction motor, doubly fed motor, single-fed electric motor, and torque motor. The gear 50 may be, for example, a planetary gear system configured to convert the rotational output of the motor 49 into linear motion of the rod 26. In some embodiments of this disclosure, the gear 50 may include a rotatable nut 51. The nut 51 may be threaded, while the rod 26 may have threads opposite to those of the nut 51. Gear 50 can convert the rotational output provided by motor 49 into the rotational motion of nut 51, and then the thread of nut 51 transmits the rotational motion of nut 51 to the opposite thread of rod, thereby causing rod to move forward or backward in the direction of rod axis.

[0068] Reference Figure 14 In some embodiments, a spatial view of the electronic module 23 and the actuation module 24 is shown. The electronic module includes a printed circuit board (PCB) 91 and a battery 45. The PCB includes hardware and software components. The actuation module includes a motor 49, a gear 50, a nut 51, a rod 26, a rod connection 27, and a rotation sensor 81.

[0069] Referring to Figure 15, in some embodiments, a configuration of the pumping mechanism of pump 6 is shown. This configuration includes two openings in reservoir 32, two openings in dosing device 33, and two check valves 34 and 35. For ease of understanding, only those parts of the pump that come into contact with the infused fluid are depicted. Figure 15aThe diagram shows the pumping mechanism in its initial state before being filled with infusion fluid. A reservoir plunger 36 is located near the second reservoir end 38, while a filling port 39 is located between the plunger 36 and end 38. A dosing device plunger 40 is located near the second dosing device end 43. The dosing device plunger 40 seals an opening (not shown) through which fluid communication is established between the first check valve 34 and the interior of the dosing device 33. Figure 15b The diagram shows the pumping mechanism immediately after the reservoir 32 has been filled with infusion fluid. Infusion fluid is injected into the reservoir 32 through port 39 using, for example, a syringe. Infusion fluid is prevented from entering the dosing device 33 by a plunger 40 that interrupts fluid communication between the check valve 34 and the interior of the dosing device 33. Thus, the infusion fluid fills the reservoir 32, causing the plunger 36 to move toward the first opening 37 of the reservoir 32. For example, filling ends when the plunger 36 reaches a stop (not shown) located near the opening 37. Figure 15c This diagram shows the state of the pumping mechanism immediately after the dosing plunger 40 has moved in the direction toward the first dosing opening 42 and reached a position closest to the first dosing opening 42. (The movement of the plunger 40 is caused by a rod 26, not shown). The movement of the plunger 40 toward end 42 causes fluid in the reservoir 32 to flow into the dosing unit 33 through the check valve 34, thereby filling the dosing unit 33. Note that the check valve 35 prevents fluid from flowing into the dosing unit 33 from the discharge port 7. Figure 15b and Figure 15c When transitioning between the states depicted, the volume of fluid entering the pressurizer 33 is substantially equal to the volume of fluid lost by the reservoir 32. Therefore, the distance the reservoir plunger 36 moves in the direction of end 38 is equal to the volume of the dosing device divided by the cross-sectional area of ​​the reservoir 32. Figure 15d This illustrates the state of the pumping mechanism immediately after the dosing plunger 40 returns to its initial position near the second end 43 of the dosing unit 33. The movement of the plunger 40 diverts the infusion fluid contained within the dosing unit 33 toward the discharge port 7 via the second check valve 35. Backflow of fluid into the reservoir 32 is prevented by the check valve 34. Figure 15e This illustrates the state of the pumping mechanism immediately after the dosing plunger 40 reaches its position closest to the first end 42 of the dosing unit 33. Upon reaching this position, the dosing unit is refilled by the infusion fluid flowing from the reservoir 32 into the dosing unit via the check valve 34. The check valve 35 prevents the fluid positioned between the dosing unit and the drain port 7 from re-entering the dosing unit. Figure 15f This shows the state of the pump after the dosing plunger 40 has circulated between its two extreme positions the required number of times, thereby evacuating all the infusion fluid through the discharge port 7. (As shown) Figure 15aAs depicted, the pump has thus returned to its initial position, except that the discharge port 7 cannot completely empty the infusion fluid. Note that the dosing plunger 40 does not need to reach any of its extreme positions to displace fluid from the reservoir through the discharge port. In some embodiments, the plunger 40 can be displaced by any amount. The plunger 40 can be displaced according to a predetermined program stored, for example, on a microprocessor, to provide a predetermined infusion profile.

[0070] Referring to Figures 16A to 16B, some embodiments show pumping mechanism designs. The pumping mechanism of pump 6 is advantageous in terms of both size and accuracy, which will be discussed in more detail below.

[0071] Dimensions: The total length of the pump can be approximately the same as the length of the reservoir. This is because the combined length of the dosing device 33 and the rod 26 is approximately equal to the length of the reservoir 32. In conventional injection pumps where the dosing device and reservoir are the same, the pump length needs to be greater than or equal to the combined length of the reservoir and the plunger rod. Therefore, in some embodiments of this disclosure, the pump length can be less than or equal to half the length of an equivalent conventional injection pump.

[0072] Accuracy: In some embodiments of this disclosure, the dosage can be significantly more accurate than in an equivalent conventional syringe pump. This is because the cross-sectional area (denoted by a) of the dosing device 33 can be 10-100 times smaller than the cross-sectional area A of the reservoir 32. Therefore, in a conventional syringe pump, the plunger displacement error d is converted into a volumetric displacement error d*A (assuming the cross-sectional area of ​​the conventional syringe pump is similar to the cross-sectional area A of the reservoir 32). In some embodiments of this disclosure, the same plunger displacement error d will be converted into a volumetric displacement error d*a that is 10-100 times smaller than that of a conventional syringe pump.

[0073] Referring to Figures 17A to 17B, in some embodiments, the upper portion of the bracket 4 is shown. Figure 17a and cross-sectional view Figure 17b The solution. In some embodiments, the bracket 4 includes a frame 52 and a bottom side 53. Figure 17b In some embodiments of this disclosure, frame 52 may have a square, rectangular, or slightly curved cross-sectional area. Figure 17b The curved shape is configured to work with pump 6 (). Figure 3The cross-sectional curvature of the frame 52 is complementary, thereby allowing the pump to be fitted into the bracket without making the overall structure thicker than the pump 6. The frame 52 can be rigid or flexible to accommodate strain caused by skin movement. The bottom side 53 of the bracket 52 can be made of adhesive paper and a protective liner that is removed before use. In some embodiments, the bottom side 53 may include an opening 54 configured to receive the discharge port 7 and the cannula 9. The opening 54 allows the patient to visually inspect the skin immediately adjacent to the cannula 9 for bleeding or irritation. In some embodiments of this disclosure, a snap-fit ​​mechanism 8 can be used to achieve a reversible connection between the pump 6 and the bracket 4.

[0074] Referring to Figures 18A to 18B, in some embodiments, spatial views of the bracket 4 are shown before (18a) and after (18b) insertion of the cannula. In some embodiments, the bracket 4 includes a frame 52, a bottom side (i.e., adhesive) 53, a discharge port 7, and a snap-fit ​​mechanism 8. After insertion, the cannula 9 is received within the discharge port 7.

[0075] Referring to Figures 19A to 19C, in some embodiments, a scheme for the infusion site interface 10 is shown. The infusion site interface includes a cannula inserter 5, a carriage 4, and a cannula 9. Figure 19a The infusion site interface 10 with inserter 5 is shown in an undeployed state. Inserter 5 includes a cannula 9, a spring 55, and a spring release button 56. Cannula 9 may include a sharp piercing member 57 and an extradermal member 58. Member 58 may include a flexible septum (i.e., silicone) disposed at its tip. To deploy cannula 9 into the patient, infusion site interface 10 is attached to the patient's skin 80 and a bracket 4 is adhered to the skin 80. Figure 19b and 19c The insertion process is illustrated. When button 56 is pressed, spring 55 is released, launching the piercing member 57 and cannula 9 into the skin 80. Subsequently, the piercing member 57 is retracted, leaving cannula 9 inside the body and member 58 outside the skin. Figure 19c Finally, the inserter 5 (not shown), including the piercing member 57, is placed and the bracket 4 is kept adhered to the skin.

[0076] Referring to Figures 20A through 20D, spatial views of the infusion site interface 10 are shown in some embodiments. The infusion site interface 10 includes an inserter 5, a cannula 9, and a bracket 4. In some embodiments, the infusion site interface 10 is a disposable component pre-assembled with the cannula 9 and the bracket 4 in a sterile blister (not shown). After being removed from the blister and the adhesive liner peeled off from the bottom side 53 of the bracket, the infusion site interface is attached to the desired location on the patient's skin. Pressing button 56 automatically inserts the cannula 9, and then retracts the puncture member 57. Figure 20a and Figure 20b (Cross-section) shows the infusion site interface 10 before the inserter 5 is inserted into the cannula 9. Figure 20c and 20d (Cross-section) shows the insertion of the cannula 9 and the retraction of the piercing member 57, while holding the member 58 above the bracket frame 52. After insertion, the bracket 4 is attached to the skin, and the cannula 9 is placed in the subcutaneous tissue beneath the skin.

[0077] Referring to Figures 21A to F, in some embodiments, a schematic top view of the device 1 ready for operation is shown. First, the user removes DP 3 (not shown) from its initial state of aseptic packaging. Figure 21a The user then fills the reservoir 32 with infusionable fluid through the filling port 39 using a syringe equipped with a needle (not shown). Once the reservoir is filled to the user's desired level, the syringe needle is withdrawn from the filling port 39, and a septum disposed therein self-seales. Now, in Figure 21b This situation is illustrated in the diagram. In the next step, RP 2 and DP 3 are connected to form pump 6. Figure 21c And perform purging (scavenging) (see Figure 22 for details). Figure 21d The infusion port interface of the inserter 5, including an operation button 56 and a bracket 4, is shown. After inserting the cannula 9, the inserter 5 is removed from the bracket 4. Figure 21e The frame 52 is then attached to the adhesive 53, and the cannula 9 is placed inside the discharge port 7. Finally ( Figure 21f Pump 6 is connected to bracket 4 and device 1 is ready for operation. The connection between pump 6 and bracket 4 provides fluid communication between pump 6 and cannula 9, and fluid can be delivered from dispenser 33 to the body. The connection between pump 6 and bracket 4 is reversible (bent arrow), so the patient may, at his / her discretion, refill the reservoir or replace the RP (i.e., low-power battery) (see Figure 23).

[0078] Referring to Figures 22A to D, in some embodiments, a perfusion treatment scheme is shown. Figure 22a The reservoir 32 is shown filled with an external syringe. The patient holds DP 3 and aligns the syringe needle with the opening 39. As fluid moves from the syringe to the reservoir, bubbles form and are randomly dispersed within the reservoir 32. Next, the patient connects RP 2 and DP 3 and holds pump 6 in an upright position. Figure 22b At this position, air bubbles accumulate on the upper side of reservoir 32. Next, the patient operates pump 6 in "infusion mode" (i.e., commanded via a remote controller). In infusion mode, the motor (not shown) operates automatically forward and backward, moving lever 26 and the dosing plunger 40 in a pre-programmed sequence (or manually after careful patient assessment). Figure 22cThe next infusion step is shown. The dosing unit 33 pumps fluid and air bubbles from the upper portion (second reservoir end 38) of the reservoir 32 into the upper portion of the dosing unit 33 (dosing unit plunger 40 moves backward). Finally, the air-bearing fluid is discharged from the dosing unit 33 to the discharge port 7 and drips further outward (dosing unit plunger 40 moves forward). The infusion process can be repeated as many times as needed until no air bubbles are visible. In some embodiments of this disclosure, the pump can be instructed to end the infusion procedure once the user visually inspects a stable fluid flow through the discharge port 7. RP 3 and the reservoir 32 may be made of translucent plastic to allow air bubbles to be visible. A sensor positioned between the dosing unit 33 and the discharge port 7 can also detect the presence or absence of air bubbles (see details). Figure 31 The pump 6 is ready for use once the infusion termination procedure is completed, and the infusion termination procedure is transmitted whenever no air bubbles are detected.

[0079] Referring to Figures 23A to 23C, in some embodiments, methods for battery replacement and reservoir refilling are shown. According to some embodiments of the invention, the lifespan of the device can be extended with patient discretion while maintaining a small device size. In addition to increased patient comfort, this configuration saves money because fewer disposable parts are required. Diabetic patients using durable (pager) or patch insulin pumps typically replace the infusion set or the entire pump every 2-3 days. Two main parameters limit the pump's lifespan—the reservoir volume (insulin units) and battery life. Extended pump operating time requires a large reservoir and a large battery, both of which increase the pump volume. Device 1 is small and can be used for many days because the reservoir is refillable and the battery is replaceable. Therefore, the reservoir and battery capacity can be minimized. Patients can decide whether they want to refill the reservoir, replace the battery, or do both simultaneously. For example, in current patch pumps, the reservoir capacity is 200U and the battery life is 3 days. If the patient's total daily dose (TTD) is 100 units (U), the patch pump should be replaced every 2 days (reservoir volume limit). If the patient's TTD is 50 units (U), the patch pump should be replaced every 3 days (reservoir life limit). In device 1, for example, with a reservoir volume of 100U and a battery life of 1 day (smaller than the current pump volume), the patient refills the reservoir and replaces the battery daily, as long as he / she wishes (e.g., 1 week).

[0080] Figure 23aPump 6, including RP 2(A) and DP 3, is shown. Battery 45 is housed within RP 2. In this example, reservoir 32 is nearly empty and should be refilled. Meanwhile, battery 45 of the second RP 2(B) is being charged by inductive charger 101. When reservoir 32 is nearly empty (the patient receives a "low reservoir capacity" alarm), the patient disconnects pump 6 from the bracket and then disconnects RP 2(A) from DP 3 (not shown). Figure 23b The image shows the reservoir 32 of DP 3 being refilled with an external syringe. After the reservoir 32 is refilled, the patient reconnects DP 3 to the second RP 2(B), which includes a recharged battery 45. Pump 6 is then ready for another use cycle. Figure 23c Then, the battery 45 of the first RP 2(A) can be recharged by the charger 101 to be ready for the next use cycle.

[0081] Referring to Figures 24A to F, in some embodiments, schemes for extending the duration of device use are shown. In this embodiment, the reservoir is pre-filled (by the patient or manufacturer). The empty reservoir is replaced with the pre-filled reservoir and the pump can be reused until the replaceable reservoir is empty. Figure 24a Device 6, including RP 2(A) and DP 3, is shown. A reservoir 32 is reversibly disposed within DP 3. In this example, reservoir 32 and dosing device 33 are empty, and the patient receives a "reservoir depleted" alarm. The patient disconnects pump 6 from the carriage (not shown) and disconnects RP 2 from DP 3 (not shown). Figure 24b DP 3 is shown, including an empty storage unit 32. Figure 24c DP 3 is shown after the removable storage unit has been removed. Figure 24d Several pre-filled receptacles 32 are shown. These receptacles can be pre-filled by patients and can be stored in a refrigerator. Alternatively, the manufacturer can fill the receptacles as pre-filled cartridges (vials). The receptacles can be made of polymer (plastic) or glass. Figure 24e DP 3 is shown, in which the pre-filled reservoir 32 is reassembled. In the final step ( Figure 24f The patient connects DP 3 (with a fully charged reservoir) and RP 2 (battery 45 rechargeable) and pump 6 is ready for another use cycle.

[0082] Reference Figure 25In some embodiments, an active valve system 61 is shown. In this embodiment, the dosing device 33 is floating (hereinafter, "floating dosing device" 33) and can move back and forth due to friction between the dosing device plunger 40 and the floating dosing device 33. RP 2 is connected to DP 3, and rod 26 is connected to dosing device plunger 40 via couplings 27 and 41. Dosing device 33 is housed within RP 2, and gasket 29 provides a seal for compartment 22. Dosing device plunger 40 moves forward or backward according to linear forward or backward movement of rod 26. Dosing device 33 can move linearly forward and backward (double arrows) relative to gasket 29. DP 3 includes a base 31, reservoir 32, reservoir plunger 36, dosing device 33, active valve system 61, conduits 66 and 67, and discharge port 7. The dosing device 33 includes a plunger 40, a plunger coupling device 41, and a sliding needle port 59, which is a hollow needle located at the distal end of the dosing device 33 and provides an outlet for fluid originating from the dosing device (hereinafter, "sliding needle"). An active valve system 61 is rigidly connected to the base 31. The active valve system 61 includes a first conduit 66, a second conduit 67, and a dual chamber 68. The dual chamber 68 includes a first septum 64, a first chamber 62, a second septum 65, and a second chamber 63. Conduit 66 establishes fluid communication between the reservoir 32 and the first chamber 62. The second conduit 67 establishes fluid communication between the second reservoir 63 and the outlet 7. Both the first septum 64 and the second septum 65 are configured to prevent fluid leakage upon puncture by the sliding needle 59. Both the first septum 64 and the second septum 65 self-seal when the needle is withdrawn from the septum puncture site. Both the first septum 64 and the second septum 65 may be made, for example, of a plastic such as silicone.

[0083] Figure 25a (1-2) shows the use of Figure 25 The example embodiment is depicted by the dashed circle. DP 3 includes a base 31 and a cylindrical extension 31', a dosing device 33, a dosing device plunger 40, and a sliding needle 59. RP 2 includes a washer 29. The dosing device 33 moves freely within the cylinder 31' (in the direction of the arrow). When RP 2 is connected to DP 3, the cylinder 31' passes through the washer 29, and the tight engagement between the cylinder 31' and the washer 29 provides a seal for the RP2 sealing compartment 21. As the plunger 40 moves forward or backward, the dosing device 33 freely follows the direction of movement because the friction between the dosing device 33 and the dosing device plunger 40 is much greater than the friction between the dosing device 33 and 31'. Figure 25a (2) Show Figure 25a (1) Cross-sectional view of plane XX. The gasket 29 tightly surrounds the cylinder 31', and the dosing device 33 can move freely forward and backward within the cylinder 31'.

[0084] Referring to Figures 26A to 26B, an enlarged representation of the active valve system module 61 is shown in some embodiments. The active valve system 61 includes a dual-chamber 68, comprising a first partition 64, a first chamber 62, a second partition 65, a second chamber 63, conduits 66 and 67, and a discharge port 7. A floating dosing device 33 is linearly movable forward and backward (arrows) between a stopper 86 (rigidly connected to RP) and a stopper 85 (rigidly connected to DP). The floating dosing device 33 is rigidly connected to a sliding needle 59. Figure 26a The active valve system is shown during the rearward movement of lever 26 and dosing plunger 40 (to the left, as indicated by the arrow). Due to friction between the floating dosing device 33 and the dosing plunger 40, the floating dosing device 33 moves rearward (to the left) relative to the washer 29 from its maximum forward position at stop 85 (dashed line) to its maximum rearward position at stop 86. During the rearward movement of the floating dosing device 33, the sliding needle 59 moves rearward and the tip 591 of the sliding needle moves from the second chamber 63 (dashed needle) to the first chamber 62. During this phase, the plunger 40 and the floating dosing device are temporarily fixed and move together (e.g., there is very little or no relative movement between the floating dosing device 33 and the plunger 40). When the floating dosing device 33 contacts the stopper 86, there is no longer any relative movement between the floating dosing device 33 and the washer 29. At this time, the continuous backward movement of the plunger 40 draws the fluid in the reservoir 32 (not shown) into the first chamber 62 through the conduit 66 and fills the floating dosing device 33. Figure 26b The active valve system is shown during the forward movement of lever 26 and dosing plunger 40 (to the right, as indicated by the arrow). The floating dosing device 33 moves forward (to the right) relative to washer 29 from its maximum rearward position (dashed line) at stop 86 to its maximum forward position at stop 85. During the forward movement of the floating dosing device 33, the sliding needle 59 moves forward and its tip 591 moves from the first chamber 62 to the second chamber 63. During this phase, plunger 40 and floating dosing device 33 are temporarily fixed to each other and are moving together (e.g., there is very little or no relative movement between the floating dosing device 33 and plunger 40). When the floating dosing device 33 contacts stop 85, there is no longer any relative movement between the floating dosing device 33 and washer 29. At this point, the continuous forward movement of plunger 40 pushes fluid in dosing device 33 through conduit 67 into discharge port 7.

[0085] Referring to Figures 27A to F, in some embodiments, a pumping mechanism employing an active valve system is shown. For ease of understanding, only those components of the pumping mechanism that come into contact with the infused fluid are depicted. Figure 27aThis diagram shows the initial state of the pumping mechanism before the reservoir 32 is filled with infusion fluid. The reservoir plunger 36 is located near the second reservoir end 38, while the filling port 39 is positioned between the plunger 36 and end 38. The dosing device plunger 40 is located near the second dosing device end 43. The second end of the floating dosing device 33 is in physical contact with the stop 85. The tip of the sliding needle 59 is located in the second chamber 63. Figure 27b The diagram shows the pumping mechanism immediately after the reservoir 32 has been filled with infusion fluid. Infusion fluid is injected into the reservoir 32 through the filling port 39 using, for example, a syringe. The infusion fluid fills the reservoir 32, causing the plunger 36 to move toward the first opening 37 of the reservoir 32. Fluid can also fill the first chamber 62 through the first conduit 66. A septum 65 prevents fluid from flowing from the first chamber 62 to (and beyond) the second chamber 63. Filling ends when, for example, the plunger 36 reaches a stop (not shown) located near the opening 37. Figure 27c The diagram illustrates the state of the pump mechanism when the motor (not shown) is operating and lever 26 moves linearly in the rearward direction (to the left as indicated by the arrow). During this phase, the floating dosing device 33 moves rearward (to the left), while the relative movement between the floating dosing device 33 and the plunger 40 is minimal or nonexistent. At the end of this phase, the first end 42 of the dosing device is in physical contact with the stopper 86, and the tip of the sliding needle is located in the first chamber 62. Figure 27d The diagram illustrates the state of the pumping mechanism when rod 26 and plunger 40 are moving backward (to the left as indicated by the arrow) and the first chamber 62 and dosing device 33 are filling with fluid. During this phase, the floating dosing device 33 is not moving and there is relative motion between the plunger 40 and the dosing device 33. Figure 27e The diagram illustrates the state of the pumping mechanism when the motor (not shown) rotates in the reverse direction and the lever 26 moves forward linearly (to the right, as indicated by the arrow). During this phase, the floating dosing device 33 moves forward (to the right), while the relative movement between the floating dosing device 33 and the plunger 40 is minimal or nonexistent. At the end of this phase, the second end 43 of the dosing device is in physical contact with the stop 85 and the tip of the sliding needle is located in the second chamber 63. Figure 27f The diagram illustrates the state of the pumping mechanism when rod 26 and plunger 40 are moving forward (to the right as indicated by the arrow) and fluid is being delivered through the second chamber 63 and conduit 67 to the discharge port 7. During this phase, the floating dosing device 33 is not moving and there is relative motion between the plunger 40 and the floating dosing device 33.

[0086] Referring to Figures 28A and 28B, cross-sectional views of an active valve system are shown in some embodiments. In this configuration, a dual chamber 68 is placed side-by-side with a floating dosing device 33, and a sliding needle 59 is bent. The dual chamber 68 is rigidly connected to a base 31 and includes a first chamber 62 and a second chamber 63. A conduit 66 is hydraulically connected to a reservoir 32 and the first chamber 62. A conduit 67 is hydraulically connected to the second chamber 63 and a discharge port 7. The floating chamber 33 is movable forward and backward relative to the base 31 and the gasket 29 (up and down, as indicated by the double arrows). The sliding needle 59 is bent and hydraulically connected to the floating dosing device 33 and the second chamber 63. As the plunger 40 moves linearly backward and forward (in the direction of the arrows), the floating dosing device 33 and the sliding needle 59 move in the same direction as the plunger 40. Therefore, the tip of the sliding needle moves forward or backward in the same direction as the floating dosing device 33 and is interchangeably positioned in either the first chamber 62 or the second chamber 63.

[0087] Referring to Figures 29A to 29C, in some embodiments, cross-sectional views (29a-b) and spatial views (29c) of the active valve system of Figure 28 are shown. The dual chamber 68 is rigidly connected to the base 31 and includes a first chamber 62 and a second chamber 63. A conduit 66 is hydraulically connected to the reservoir 32 and the first chamber 62. A conduit 67 is hydraulically connected to the second chamber 63 and a discharge port (not shown). Figure 29a and Figure 29b Two optional positions for the tip 591 of the sliding needle are shown. Figure 29a In the middle, the tip 591 is placed in the first chamber 62, and in Figure 29b The tip 591 is placed in the second chamber 63. Figure 29c The floating dosing device 33 is shown, which moves linearly relative to the base 31 and the washer 29 (in the direction of the double arrows). Therefore, the sliding needle 59 moves linearly relative to the dual chamber 68.

[0088] Referring to Figures 30A to 30B, some embodiments of an active valve system are shown. In this configuration, the floating dosing device 33 has two openings 74 and 76 (different from the single opening shown in the configuration of Figure 28). DP 3 includes a base 31, a reservoir 32, the floating dosing device 33, a cylinder 79, conduits 66 and 67, and a discharge port 7. The floating dosing device 33 includes two openings 74 and 76, and the cylinder 79 includes two openings 77 and 78. The floating dosing device 33 can move linearly (forward and backward in the direction of the arrows) within the cylinder 79 according to the direction of movement of the plunger 40 and the rod 26 (due to the friction between the plunger 40 and the dosing device 33). The concept of the pumping mechanism is similar to that of Figure 15, where the backward movement of the plunger 40 pumps fluid from the reservoir 32 and fills the dosing device 33, and the forward movement of the plunger 40 distributes the fluid in the dosing device 33 to the discharge port 7. Figure 30aThe filling process of the dosing device 33 is shown. Initially, the rearward movement of the floating dosing device 33 (to the left, as indicated by the arrow) aligns with openings 76 and 77 (opening 74 is closed). When the dosing device end 42 contacts the stopper 86, further rearward movement of the plunger 40 pumps fluid from the reservoir 32 into the dosing device 33. Figure 30b The process of dispensing fluid from dosing device 33 is illustrated. Initially, the forward (to the right, as indicated by the arrow) movement of the floating dosing device 33 aligns with openings 74 and 78 (opening 74 is closed). When the dosing device 33 contacts the cylinder 79, further forward movement of the plunger 40 dispenses fluid from the dosing device 33 into the discharge port 7. Subsequently, when the dosing device 33 is empty, the plunger 40 moves backward and initiates another dosing device filling cycle.

[0089] Reference Figure 31In some embodiments, a scheme of electronic module 23 and actuation module 24 of pump 6 is shown. Pump 6 includes RP 2 and DP 3. RP 2 includes a housing 44 and a partition 20 dividing RP 2 into two separate compartments (a sealed compartment 21 and a ventilated compartment 22). The partition 20 and housing 44 may be partially or completely transparent. In some embodiments, the partition 20 and the housing wall facing DP 44' include transparent windows, thereby providing location lines between the sealed compartment 21 and the reservoir 32, and between the sealed compartment 21 and DP 3. DP 3 includes the reservoir 32, the reservoir plunger 36, the dosing device 33, the dosing device plunger 40, the conduit 67, and the discharge port 7 (other components of DP 3 are not shown). When DP 3 and RP 2 are connected (forming pump 6), the reservoir 32 is disposed within the ventilated compartment 22, and the dosing device 33 is disposed within the sealed compartment 21. Electronic module 23 (dashed line) includes a power source (battery) 45, a processor 48, a transceiver 46, a buzzer 99, and sensors—an accelerometer 47, a low battery sensor 92, a bubble sensor 95, a rotational speed sensor 81, a blockage sensor 97, a low reservoir sensor 98, and dosing plunger position sensors 93 and 94. Actuation module 24 includes a motor 49, a gear 50, and a rod (drive screw) 26. Power source 45 may be a single-use battery or a rechargeable battery. In some embodiments of this disclosure, power source 45 is rechargeable, and recharging may be achieved in a contactless manner. For example, a sensing mechanism may be used to recharge power source 45. In some embodiments of this disclosure, power source 45 is rechargeable and recharging may be achieved by providing electrical contact through the housing 44 of RP 2. Power source 45 may supply power to any component of electronic module 23 and actuation module 24. Transmitter / receiver 46 may be, for example, a wireless transmitter / receiver. In some embodiments of this disclosure, the transmitter / receiver 46 may be a Bluetooth radio, and more specifically, the transmitter / receiver 46 may be a Bluetooth Low Energy (BLE) radio. The accelerometer 47 may be a sensor configured to measure acceleration applied to the pump 6 along all three physical axes (x, y, and z). In some embodiments of this disclosure, the accelerometer 47 may measure gravitational acceleration, while in other embodiments, the accelerometer 47 may not measure gravity. In some embodiments of this disclosure, the accelerometer 47 may measure the rate of rotation of the pump 6 about each of the three physical axes. The accelerometer 47 is connected to a processor 48, which processes the acceleration data and calculates the patient's energy expenditure (calorie consumption). The energy expenditure data is a key parameter used for adjustments to suit the patient's basal insulin delivery rate, calculating daily total insulin doses, related activities, calorie consumption, and calculating dietary dose delivery using a dosing calculator. The accelerometer 47 may continuously monitor body movement and may be used as a primary indicator for detecting hypoglycemia at night. In some embodiments of this disclosure, the accelerometer 47 may be used as an interface between the patient and the pump 6.For example, instructions can be provided to the microprocessor 48 by tapping the pump 6 and causing a certain tap sequence, detected by the accelerometer 47, corresponding to a specific instruction, and subsequently processed by the microprocessor. For example, in some embodiments where the infusion fluid is designed to provide glucose-controlled insulin in a diabetic patient, a specific tap may correspond to various sizes of pre-meal insulin doses. For example, if each tap is pre-programmed for 1 unit of insulin, administering 6 units requires 6 taps. The microprocessor 48 may be a chip that integrates the full functionality of a computer central processing unit on one or more integrated circuits. The microprocessor 48 may receive digital data from the transmitter / receiver 46 and the accelerometer 47. The microprocessor 48 may process the input according to instructions stored in its memory and provide results as outputs. Thus, inputs and outputs to and from the microprocessor 48 may flow to and from the transmitter / receiver 46, the accelerometer 47, the buzzer 99, and the sensors. Transmitter / receiver signals may be initiated in remote controllers, smartphones, and personal computers using RF radio communication protocols such as Bluetooth or Bluetooth Low Energy. In some embodiments of this disclosure, the signal received at transmitter / receiver 46 may originate from a blood glucose meter, a continuous glucose monitor, or any physiological sensor that may be external to pump 6. Signals originating from sensors internal to pump 6 may be received directly in microprocessor 48. Output from microprocessor 48 may be a signal directed to actuator module 24 and intended to cause lever 26 to advance or retract linearly. Output from microprocessor 48 may also be sent by transmitter / receiver 46 to external devices such as remote controllers, smartphones, personal computers, and servers. Microprocessor 48 may store in its memory a computer program intended to cause dosing device 33 to deliver infusion fluid in a predetermined manner. In some embodiments of this disclosure, microprocessor 48 may store in its memory a computer program implementing a closed-loop control algorithm. Microprocessor 48 may receive and process inputs from various sensors embedded at designated locations on printed circuit board (PCB) 91. Data received from the sensor and processed by the processor can be wirelessly transmitted via transceiver 46 to any remote controller / monitor (controller 200, smartphone 500, PC 600, etc.) and can be presented as warnings and / or alarms. Low battery sensor 92 warns the patient to replace RP 2 before the battery life ends. Upon receiving the warning, the patient should disconnect pump 6 from bracket 5, disconnect RP 2 and DP 3, and then reconnect DP3 and a fully charged RP 2, as shown in Figure 23. Rotation sensor 81 counts the motor revolutions using any device known in the art (e.g., two or more blades rotating between light-emitting diodes (LEDs) and photodiodes).The microprocessor 48 evaluates the data from the rotation speed sensor 81 (counting rotations). If a mismatch exists between the programmed rotation speed count and the real-time rotation speed count (i.e., some pulses are missed), the patient receives a warning or alarm (presented on any user interface). A mismatch between the processor command and the actual motor rotation speed (missed pulses) could be a consequence of motor jamming (i.e., a broken hinge or gear) or high resistance to motor rotation (i.e., a blocked fluid path). The blockage sensor 97 detects the torque between the motor 49 and gear 50, and between gear 50 and rod 26 (drive screw). An increase in torque in the gears or motor can be due to motor or gear failure or increased resistance to motor operation due to blockage in the fluid flow path. Figure 34 As shown, the distinction between motor / gear failure and fluid path blockage can be achieved by moving the processor command lever 26 backward (i.e., reversing the motor rotation direction (i.e., from clockwise to counterclockwise). If the torque increase is due to a gear or motor failure (i.e., a broken hinge), the torque remains high when the motor rotation direction is reversed. If the torque increase is due to blockage (high resistance), the torque decreases when the motor rotation direction is reversed. Data from the blockage sensor 97 is evaluated by the processor 48, sent to any user interface, and presented as a blockage warning (alarm). User action upon receiving a blockage alarm is shown in Figure 35. Plunger position sensors 93, 94, and 98 include LEDs and photodiodes; their operating principles are further detailed in Figure 36. When the reservoir 32 is low and should be refilled (as shown in Figure 23), the end of the reservoir sensor 98 detects the position of the reservoir plunger 36. In some embodiments, an additional plunger position detector may be provided to alert the patient when the reservoir volume reaches a predetermined threshold (i.e., the insulin dose is decreasing -100U, 90U, 80U...up to 20U, and when the reservoir should be refilled). In one embodiment, a window (not shown) in the septum 20 (dividing the sealed compartment 21 and the ventilated compartment 22 of RP 2) provides a location line between the end of the reservoir sensor 98 and the reservoir 32. When the plunger 36 reaches the end of the volume position, it aligns with the window and blocks light transmission through the window. Sensors 93 and 94 detect the position of the dispenser plunger 40 at the beginning and end of its movement within the dispenser 33. Figure 36 further illustrates a detailed description of the operating modes of sensors 93 and 94. Sensors 93 and 94 provide the position of the plunger 40 to the processor 48 and accordingly control the rotation direction of the motor 49 and the forward or backward movement of the lever 26, as shown. Figure 34As described in detail below. A bubble sensor 95 detects bubbles traveling in the conduit 67 toward the outlet 7. The bubble sensor 95 can be operated using piezoelectric ultrasonic transducers. The propagation time is measured based on the alternating transmission and reception of ultrasonic pulses in and against the flow direction. The sensor performs non-contact detection of air and bubbles in the liquid through the conduit wall, allowing for continuous quality monitoring. Two piezoelectric ultrasonic transducers act as transmitter and receiver. In another embodiment, the bubble sensor 95 is an optical sensor that detects light transmission through the transparent conduit 67. In this configuration, the sensor 95 faces the window (not shown) on the side of the RP housing 44' facing DP 3.

[0090] Reference Figure 32 In some embodiments, a longitudinal cross-section of device 1 is shown. Pump 6 includes RP 2 and DP 3. Pump 6 is connected to a bracket 4 adhered to the patient's skin 80. DP 3 includes a base 31, an outlet 7, a catheter 67, and a connecting needle 88. Member 58, including a septum 58', is connected to a catheter 9 through an opening 54 of the bracket 4. The connecting needle 88 pierces the septum 58' and is disposed within member 58, thereby providing fluid communication between the catheter 67 and the cannula 9. As shown in FIG. 17, pump 6 can be connected to bracket 4 using a snap-fit ​​mechanism 8. In some embodiments, bracket 4 is connected to pump using magnets 111, 112. Magnets 111 and 112 can be disposed in RP 2 or bracket 4, and the ferromagnetic member can be interchangeably located on the other side. The ferromagnetic member can be the housing 44 of RP 2. The magnets within RP 2 can be permanent magnets or electromagnets.

[0091] Referring to Figures 33A to 33B, in some embodiments, a scheme showing a reversible magnetic (33a) and mechanical (33b) connection between rod 26 and dosing plunger 40 is illustrated. During the engagement of RP 2 and DP 3, for example after refilling, rod 26 and plunger 40 should engage such that linear forward and backward movement of rod 26 moves plunger 40 and dosing device 33, as detailed in Figure 26. Figure 33a The diagram illustrates a scheme for a magnetic connection between rod connecting device 27 and plunger connecting device 41. Magnets can be housed in both connecting devices, and antiferromagnetic components can be housed in opposing connecting devices. Figure 33b A mechanical connection scheme is shown; in this example, it is a ball-and-socket mechanism. The rod connection device 27 reversibly engages with the plunger connection device 41. Combinations of mechanical and magnetic connections are also possible.

[0092] Reference Figure 34In some embodiments, schemes of operation modes (1-6) of motor 49 during various stages of plunger movement and fluid dispensing are shown. Under the command of processor 48 (1), motor 49 rotates clockwise and causes plunger 40 (2) to move forward (arrow direction) via gears (not shown). When plunger 40 reaches the “end of the dosing point” 40' (detected by a plunger position and / or rotation sensor (not shown) or calculated by an algorithm), processor 48 receives a signal (3) and commands motor 49 to rotate in the opposite direction (counterclockwise) (4). The counterclockwise rotation of motor 49 causes plunger 40 to move backward (arrow) (5). When plunger 40 reaches the initial point 40', processor 48 receives a command to reverse the rotation direction (6) and the operation cycle restarts.

[0093] Referring to Figures 35A to 35B, in some embodiments, a protocol for handling a patient upon receiving an obstruction alarm is shown. Obstruction in the fluid path can occur within pump 6 (i.e., Figure 25 Obstruction within catheters 66 and 67 (as shown) or obstruction of cannula 9 (e.g., in the case of cannula kinking or insulin crystallization). Due to obstruction of cannula 9, cannula 9, bracket 4, and component 58 need to be replaced. Due to obstruction of the in-pump catheter, DP 3 needs to be replaced. When the patient receives an obstruction warning on controller 200 ( Figure 35a When pump 6 is disconnected from bracket 4 and component 58, pump 6 should be disconnected. Figure 35b When pump 6 is operating (i.e., administering a small dose) and there is no blockage within the pump, droplets of fluid should be seen emerging from the connecting needle 88 and the blockage warning should disappear. In this case, the blockage is located within the cannula 9, and therefore the bracket 4, component 58, and cannula 9 should be replaced. If no droplets are seen during pump operation and the blockage warning persists, the blockage is located within the pump, and DP 3 should be replaced.

[0094] Referring to Figures 36A and 36B, in some embodiments, a configuration of the end of the reservoir sensor 98 is shown. The sensor 98 detects the position of the plunger 36 within the reservoir 32. A septum 20 divides the RP 2 into a ventilated compartment 22 and a sealed compartment 21. The septum 20 includes a transparent window 20' that provides a line of reference between the ventilated and sealed compartments. The reservoir 32 is disposed within the ventilated compartment 22, and the sensor 98 is disposed within the sealed compartment 21. In one embodiment, the end of the reservoir sensor 98 includes an LED 121 and a photodiode 122. During pump operation, the volume of the reservoir 32 continuously decreases, and the plunger 36 passively moves forward. Figure 36a This illustrates the situation when the plunger 36 is not aligned with the window 20'. In this condition, as indicated by the arrow, light emitted from the LED 121 passes through the transparent window 20'. Figure 26bThis shows the position of plunger 36 when the reservoir is indicated for replacement (e.g., when the remaining volume of insulin is 10U, pre-programmed by the manufacturer or patient). When plunger 36 is aligned with window 20', light emitted from LED 121 is reflected and detected by photodiode 122 (arrow). Accordingly, a signal from the sensor goes to the processor, is transmitted to the controller, and is displayed to the patient when the reservoir warning ends. In some embodiments, sensor 98 may include a piezoelectric ultrasonic transducer operating as both a transmitter and receiver. This can be achieved by... Figure 31 Sensors 93 and 94 use the aforementioned light or sound detection devices to detect the position of the dosing plunger 40.

[0095] Reference Figure 37In some embodiments, a block diagram of a diabetes management system 100 is shown. System 100 includes an infusion pump 6, a charger 101, a controller 200, a smartphone 500, a blood glucose meter (BGM) 400, and a blood glucose meter (CGM) 300. The infusion pump 6 includes a reusable component (RP) 2 and a disposable component (DP) 3 (forming the pump 6 when connected). The BGM 400 and CGM 300 can be used as standalone devices. The CGM 300 can receive blood glucose readings directly from the BGM 400 for calibration. The controller 200 can be any electronic device that communicates with the RP 2 using any proprietary or public RF communication protocol. In some embodiments, the controller 200 is any electronic device that communicates with a remote server (cloud communication) and the RP 2. In this configuration, pump operation and personal data software can be downloaded from the remote server and stored within any electronic device of the controller 200, which becomes the RP 2. The smartphone 500 can be any electronic device that communicates with the controller using any proprietary or public RF protocol and has cellular communication capabilities. RP 2 includes an electronics module 23 and an actuation module 24. The electronics module 23 includes a processor 48, a transceiver 46, a battery 45, an accelerometer 47, reservoir and dosing sensor 93, 94, 98, a rotational speed sensor 81, a buzzer and bubble sensor (not shown), and an artificial pancreas (AP) algorithm 120 (located within the processor 48, as shown by dashed lines). The battery 45 is recharged via induction using a charger 101. The controller 200 includes a processor (not shown), a user interface 130, a transceiver 140, and a dosage calculator 150. The controller 200 may include a microphone, a speaker, and a camera (not shown). The smartphone 500 includes a user interface 160 and a transceiver 170. In some embodiments, the AP algorithm 120 may be located in the controller 200, the dosage calculator may be located in RP 2, or both may be located in either the controller 200 or RP 2. Now, referring to RP 2, the processor 48 includes a CPU, memory, operating software, and the AP algorithm. Processor 48 receives input from accelerometer 47, sensors 93, 94, 97, 98, 81, CGM 300, BGM 400, and controller 200. Transceiver 46 receives input from the controller, CGM, and BGM to processor 48. The output of processor 48 is commands to actuator module 24, and warnings, alarms, and log files are sent to controller 200 via transceiver 46. Referring now to controller 200, controller transceiver 140 communicates bidirectionally with RP 2 and CGM 300 using any RF communication protocol, and unidirectionally with BGM 400 (input) and smartphone 500 (output). User interface 130 can be a touchscreen, button, microphone, or camera. Patient commands (i.e., insulin dosage, changes in baseline profile, etc.) can be received by user interface 130 and sent to RP 2 via transceiver 140.The patient's commands can be transmitted to smartphone 500 and, after careful consideration by the patient, further transmitted to a remote observer (i.e., the child administers insulin and his / her parents receive the data online on their smartphones). Controller 200 can receive and display online stored data (such as continuous glucose levels, warnings, alarms, and log files) from CGM 300. Dosage calculator 150 can use data from the CGM. Controller 200 can transmit inputs to CGM 300, such as blood glucose levels received from BGM 400 for CGM calibration. Controller 200 can receive and display online stored data (such as blood glucose levels, warnings, alarms, and log files) from BGM 400. Dosage calculator 150 can use data from BGM 400. Dosage calculator 150 is software that provides the patient with a single insulin dose recommendation before meals. The dosage calculator software is housed within the controller processor (not shown). Inputs for the dosing calculator include the following data points: carbohydrate content and glycemic index and delivery pattern of the patient's diet received via the user interface; onboard insulin (remaining insulin from the previous dose) calculated by the processor; blood glucose received from BGM 400; and blood glucose level trends received from CGM 300. Insulin sensitivity index and carbohydrate factors can be received from a healthcare provider or patient via user interface 130 and can be stored within the controller processor. If the dosing calculator is mounted on processor 48 of RP 2, all data received from the user is transmitted from controller 200 to RP 2, and data points from BGM 400 and CGM 300 are transmitted directly to RP 2. Dosing calculations are performed within processor 48. Now, refer to smartphone 500. The smartphone includes user interface 160 and transceiver 170. Smartphone 500 can receive input from RP 2, controller 200, CGM 300, and BGM 400. Input can be displayed and / or transmitted to a remote workstation (i.e., family member, physician, etc.) via cellular protocols for cloud 700. In some embodiments (e.g., ...). Figure 37In this system, a smartphone can be used as the RP 2 controller. Now, referring to the operating modes of the diabetes management system 100: In the first operating mode (“manual”), the patient programs the pump 6 using the controller 200. Programming the controller 200 includes setting the basic delivery mode and on-demand dosage commands. In the second operating mode (“open-loop system”), the processor 48 continuously receives glucose readings from the CGM 300 via transceiver 46 and thus regulates the operation of the actuator module 24 and the administration of insulin from the reservoir 32 and the dosing device 33. In this operating mode, the dietary dosage commands set by the patient are transmitted from the controller 200 to the processor 48, and thus the processor 48 commands the operation of the actuator module 24 and the administration of insulin from the reservoir 32 and the dosing device 33. In the third operating mode (“artificial pancreas” or “closed-loop system” or “automatic glucose control system”), the controller 200 is not involved and the basic insulin delivery and dosage administration are fully automatic. The artificial pancreas (AP) algorithm software 120 is housed within the processor 48 (dashed line) and controls the operation of the actuator module 24 based on the patient's glucose level, which is continuously transmitted from the CGM 300 to the processor 48 via transceiver 46. Insulin administration data, warnings, and alarms can be transmitted to the controller 200 or smartphone 500, thereby providing the patient with continuous data on the operation of the pump 6 and glucose levels.

[0096] Reference Figure 38 In some embodiments, a block diagram of an insulin management system 100 is shown. The insulin management system 100 includes a network server 900, a bridging device 1000, and an insulin patch pump 1. A bidirectional data communication channel 901 exists between the server 900 and the bridging device 1000, and a bidirectional data communication channel 902 exists between the bridging device 1000 and the pump 1.

[0097] Referring to Figures 39A to 39B, examples of bridging devices (ad) are shown in some embodiments. Bridging device 1000 can be any consumer electronic device including a user interface and an RF transceiver. For example, bridging device 1000 can be a smartphone 500, 501 (39a-b), a smartwatch 502 (39c) (i.e., an iWatch, a Pebble watch), a PC 600 (39d), and a tablet computer (not shown). Communication 902 between bridging device 1000 and pump 1 can be RF communication ( Figure 39a c, d) or Near Field Communication (NFC) Figure 39b Communication 901 between server 900 and bridge device 1000 via cloud 700 can be cellular or RF (i.e., Wi-Fi).

[0098] Reference Figure 40In some embodiments, a schematic diagram of server 900 is shown. Server 900 includes CPU 901, data communication module 902, and memory 903. Memory 903 may store patient data 910 (such as the patient's insulin management procedures and records, and the unique identifier of pump 6).

[0099] Reference Figure 41 In some embodiments, a schematic diagram of a bridging device 1000 is shown. The bridging device 1000 includes a CPU 1001, a data communication module 1002, a memory 1003, and a human-machine interface 1004. The memory 1003 stores pump identifiers, patient data, insulin delivery instructions, and software for pump control. A software application 1008, downloadable from an app store such as Apple's App Store or Google's Google Play, is stored in the memory 1003. The software application 1008 is configured to give the bridge 1000 the ability to instruct and control the pump 1 and enable information communication between the pump 1 and the server 900. To enable the insulin management system 1 to operate, the user performs the following steps:

[0100] If software application 1008 is not already on bridging device 1000, the user will download application 1008 to bridging device 1000. Once the application is on bridging device 1000, its integrity will be verified.

[0101] Application 1008 on bridge 1000 requests user authentication (such as password, fingerprint or other biometric data).

[0102] • User authentication information provided by the user to the bridge 1000 is provided to the server 900 via channel 901, where the user ID, which is part of the patient data 910, is verified.

[0103] If authentication is successful, the server will send part or all of the user data 910 (including pump identification information) to bridge 1000.

[0104] • Bridge 1000 and pump 1 are paired.

[0105] Optionally, notify the user that bridge 1000 and pump 1 have been paired.

[0106] Optionally, the user authorization bridge 1000 sends user data to pump 1.

[0107] Pump 1 stores user data 910. Optionally, Pump 1 verifies user data 910 and decrypts the data if it is signed and / or encrypted.

[0108] Pump 1 is ready to deliver insulin based on the user's data 910.

[0109] Note that the insulin management system 100 allows users to easily, safely, and quickly endow various bridging devices with controller capabilities. Therefore, for example, if a given bridging device 1000 becomes inoperable (battery depleted, device forgotten or lost, etc.), another readily available bridging device can be easily and quickly made operational by downloading the software application 1008 and performing authentication processing relative to the server. When using the software application 1008 on the bridging device 1000, the user can provide insulin delivery commands to the pump:

[0110] • The user provides instructions to the bridge 1000 through the human-machine interface 1004.

[0111] • Bridge 1000 transmits instructions to pump 1 via channel 902.

[0112] • Notify the user of the command received by pump 1.

[0113] • Bridge 1000 records instructions on server 900 as early as possible so that they can be used for new bridging devices when needed.

[0114] Another embodiment of this application includes a portable fluid delivery device comprising: a first reservoir; a second reservoir having a plunger; a discharge port; a first conduit configured to allow unidirectional fluid communication from the first reservoir to the second reservoir; and a second conduit configured to allow unidirectional fluid communication from the second reservoir to the discharge port; wherein displacement of the plunger in a first direction is designed to cause fluid to flow from the first reservoir through the first conduit to the second reservoir, and displacement of the plunger in the opposite direction to the first direction is designed to cause fluid to flow from the second reservoir through the second conduit to the discharge port. In some embodiments, the first reservoir includes a filling port for receiving fluid into the first reservoir and / or a pre-filled replaceable reservoir. Additionally, the first reservoir includes a second plunger configured to move between the two ends of the first reservoir, in the first direction and / or in the opposite direction to the first direction, wherein the advancement of the second plunger in the opposite direction to the first direction is configured to cause fluid in the first reservoir to flow to the second reservoir.

[0115] In some embodiments, the portable fluid delivery device includes an electronics module and an actuation module for operating a plunger to move in a first direction and / or opposite to the first direction. In some embodiments, the electronics module includes a power supply, a processor, a transceiver, a buzzer, and / or a sensor, wherein the power supply includes a replaceable modular battery or a rechargeable battery. Additionally, the sensor may include one or more of the following: a motion sensor, a power sensor, a bubble sensor, a rotation speed sensor, a blockage sensor, a reservoir level sensor, and / or a plunger position sensor. In some embodiments, a first reservoir may include a first reservoir plunger, and the reservoir level sensor may include a first reservoir sensor configured to detect the position of the first reservoir plunger within the first reservoir to determine the amount of fluid remaining in the first reservoir. In some embodiments, the reservoir level sensor may include a second reservoir sensor configured to detect the position of a plunger in a second reservoir to determine the amount of fluid remaining in the second reservoir. Additionally, a bubble sensor may detect bubbles traveling through a second conduit.

[0116] In some embodiments, the actuation module may include an actuator and a rod configured to be functionally coupled to a plunger to drive the plunger to displace in a first direction and / or opposite to the first direction. In some embodiments, the actuation module includes an actuator and a rod configured to be functionally coupled to a plunger to drive the plunger to displace in a first direction and / or opposite to the first direction. Additionally, the portable fluid delivery device may include a rod coupling device coupled to the rod and a plunger coupling device coupled to the plunger, wherein the connection between the rod coupling device and the plunger coupling device allows the rod to be functionally coupled to the plunger, and wherein the connection between the rod coupling device and the plunger coupling device is mechanical and / or magnetic. In some embodiments, during maximum displacement of the plunger in the first direction, the distal end of the first reservoir may be aligned with or extend beyond the distal end of the rod.

[0117] In some embodiments, a portable fluid delivery device includes: a first reservoir; a second reservoir having a plunger, a first opening, and a second opening; a discharge port; a first conduit for establishing fluid communication between the first reservoir and the second reservoir when the end of the first conduit is aligned with the first opening; and a second conduit for establishing fluid communication between the second opening and the discharge port when the end of the second conduit is aligned with the second opening; wherein displacement of the plunger in a first direction is configured to align the end of the first conduit with the first opening, and displacement of the plunger in a direction opposite to the first direction is configured to align the end of the second conduit with the second opening. In some embodiments, the first reservoir includes a filling port for receiving fluid into the first reservoir, and / or the first reservoir includes a pre-filled replaceable reservoir. In some embodiments, the first reservoir includes a second plunger configured to switch between the two ends of the first reservoir, in a first direction, and / or in a direction opposite to the first direction, wherein advancement of the second plunger in the direction opposite to the first direction is configured to cause fluid in the first reservoir to flow to the second reservoir.

[0118] Additionally, in some embodiments, the portable fluid delivery device includes an electronic module and an actuation module for operating a plunger to move in a first direction and / or opposite to the first direction, wherein the electronic module includes a power supply, a processor, a transceiver, a buzzer, and / or sensors. In some embodiments, the sensors may include one or more of the following: a motion sensor, a power sensor, a bubble sensor, a rotation speed sensor, a blockage sensor, a reservoir level sensor, a second reservoir motion sensor, a second reservoir position sensor, and / or a plunger position sensor. In some embodiments, the actuation module includes an actuator and a rod configured to be functionally coupled to the plunger to drive the plunger and / or the second reservoir to move. Additionally, the actuation module may include a rod coupling device coupled to the rod and a plunger coupling device coupled to the plunger, wherein the connection between the rod coupling device and the plunger coupling device allows the rod to be functionally coupled to the plunger, and wherein the connection between the rod coupling device and the plunger coupling device is mechanical and / or magnetic. In some embodiments of the portable fluid delivery device, when the plunger is displaced to its maximum extent in a first direction, the distal end of the first reservoir aligns with or extends beyond the distal end of the rod.

[0119] In some embodiments, a disposable skin interface for a portable fluid infusion device includes a disposable component (DP) and a reusable component (RP), the DP including a first reservoir and a second reservoir with a plunger, and the RP including at least two compartments for receiving the first and second reservoirs, respectively. The disposable skin interface includes: a cannula; a removable inserter for inserting the cannula through a body surface; and a bracket for providing support to the cannula and inserter, the bracket being configured to establish a reversible connection with the portable fluid infusion device when the inserter is removed from the bracket, so that fluid flows from the second reservoir of the portable fluid infusion device into the body upon plunger displacement. In some embodiments, the removable inserter further includes a skin-piercing member connected to the inserter to facilitate cannula insertion through a body surface, wherein the skin-piercing member is configured to retract into a removable connector, thereby embedding the cannula within the body surface. Additionally, the bracket can be reversibly connected to the portable fluid infusion device via a magnetic and / or mechanical connection between the bracket and the portable fluid infusion device. The magnetic connection between the bracket and the portable fluid infusion device includes a magnetic connection between the bracket and one or more of the following: a ferromagnetic material in the RP housing, a magnet in the RP, an electromagnet in the RP, and a magnetic metal in the DP. In some embodiments, the mechanical connection between the bracket and the portable fluid infusion device may include a snap-fit ​​mechanism. The bracket may include a window to allow visibility of the cannula insertion site reaching the body surface.

[0120] In some embodiments, the diabetes management system includes at least one of a blood glucose monitor (BGM) and a continuous glucose monitor (CGM), wherein the BGM is configured to measure blood glucose levels in the body and transmit the blood glucose levels to a processor; and the CGM is configured to detect data on blood glucose level trends in the body and transmit the blood glucose level trend data to the processor. Additionally, the management system includes a portable insulin infusion device, which is communicatively coupled to a controller and / or a smartphone and configured to deliver a predetermined amount of insulin to the body upon receiving an instruction from the processor. In some embodiments, the processor may be communicatively coupled to at least one of the blood glucose monitor (BGM) and the continuous glucose monitor (CGM) and may be configured to: determine the amount of insulin to be delivered to the body based on transmitted blood glucose levels from at least an external device, transmitted blood glucose level trend data, and / or the body's health data; and transmit an instruction to the portable insulin infusion device instructing the amount of insulin to be delivered to the body. In some embodiments, the system operates in a closed-loop mode, wherein the processor is a processor within the insulin infusion device, and / or in an open-loop mode, wherein the processor is a processor within an external device. Additionally, the portable insulin infusion device may include sensors, including at least one of a motion sensor, a power sensor, a bubble sensor, a rotation speed sensor, an obstruction sensor, a reservoir level sensor, and a plunger position sensor; the portable insulin infusion device may transmit data measured by the sensors to a controller and / or a smartphone.

[0121] In some embodiments, a method for delivering fluid into the body includes the following steps: establishing contact with a body surface via a disposable skin interface configured to insert a cannula into the body; setting up a portable fluid delivery device, the portable fluid delivery device including a disposable component (DP) and a reusable component (RP), the DP including a first reservoir having fluid and a second reservoir having a plunger, the RP including an actuation module; and operating the actuation module: displacing the plunger in a first direction to cause fluid to flow from the first reservoir to the second reservoir; displacing the plunger in the opposite direction to cause fluid to flow from the second reservoir to the outlet of the portable fluid delivery device; and establishing fluid communication between the outlet of the portable fluid delivery device and the cannula inserted into the body to allow fluid to enter the body.

[0122] In some embodiments, a diabetes management system includes: a portable fluid infusion device configured to deliver a volume of fluid to a patient upon receiving a fluid infusion command; a bridging device; and a server communicatively connected to the portable fluid infusion device and the bridging device, configured to: provide the bridging device with an application for controlling the operation of the portable fluid infusion device; and authorize access to the application for authenticating users of the bridging device. In some embodiments, the bridging device communicatively connected to the portable fluid infusion device is configured to: receive patient data from users of the portable fluid infusion device and / or the bridging device; determine the volume of fluid to be delivered to the body based on at least the received patient data; and transmit a fluid infusion command to the portable fluid infusion device indicating the volume of fluid to be delivered to the body.

[0123] In some embodiments, a method of operating a fluid infusion device includes the steps of: receiving an alarm indicating a blockage from a blockage sensor in a portable fluid infusion device, the portable fluid infusion device including a disposable component (DP) having a discharge port and a reusable component (RP) including an actuator module and a blockage sensor; operating the actuator module to determine the cause of the blockage; determining the presence of fluid flow leaving the discharge port due to operation of the actuator module; and replacing the DP if no fluid flow leaving the discharge port is detected. The method further includes the steps of: replacing the cannula if the presence of fluid flow leaving the discharge port is detected, wherein a disposable skin interface including the cannula provides an interface allowing the portable fluid infusion device to infuse fluid into the body, and wherein the blockage sensor determines the occurrence of a blockage based on a torque comparison at the actuator module as the motor of the actuator module rotates clockwise and counterclockwise.

[0124] In some embodiments, a method for removing air bubbles from a fluid delivery device includes the steps of: orienting the portable fluid delivery device to cause air bubbles within a reservoir having a plunger to migrate toward an opening at the end of the reservoir, wherein the reservoir includes a plunger; the portable fluid delivery device includes: a disposable component (DP) having a reservoir and a discharge port and a reusable component (RP) including an actuation module. The method further includes the step of: operating the actuation module to cause the plunger to oscillate until at least a significant amount of air bubbles are discharged through the discharge port, wherein the plunger oscillates at a pre-programmed rate. In some embodiments, the method further includes the step of determining the presence of air bubbles by means of a bubble sensor that detects the travel of air bubbles through a conduit leading to the discharge port, wherein the bubble sensor is operated by a piezo-ultrasonic transducer, the conduit is transparent, and the bubble sensor includes an optical sensor that detects light transmission through the transparent conduit.

[0125] While various embodiments of the invention have been described and illustrated herein, those skilled in the art will readily conceive of various other means and / or structures for performing functions and / or obtaining one or more of the advantages described herein, each of which is considered to be within the scope of the embodiments of the invention described herein. More generally, those skilled in the art will readily recognize that all parameters, dimensions, materials, and configurations described herein are meant to be illustrative and that actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications using the teachings of the invention. Those skilled in the art will recognize, or can determine, many equivalents of the specific embodiments of the invention described herein using only conventional experimentation. Therefore, it is to be understood that the foregoing embodiments are presented by way of example only and, within the scope of the appended claims and their equivalents, the embodiments of the invention may be practiced in ways different from those specifically described and claimed. The embodiments of the invention disclosed herein are directed to each individual feature, system, article of manufacture, material, kit, and / or method described herein. Furthermore, any combination of two or more features, systems, articles of manufacture, materials, kits, and / or methods is included within the scope of the invention disclosed herein, provided that these features, systems, articles of manufacture, materials, kits, and / or methods are not contradictory. At least some of the disclosed embodiments can be distinguished from the prior art by explicitly lacking one and / or other features that teach in the prior art. Therefore, the claims relating to these embodiments can be distinguished from the prior art by including negative limitations.

[0126] Furthermore, various inventive concepts can be implemented as one or more methods, examples of which have been provided. Actions performed as part of this method can be ordered in any suitable manner. Therefore, embodiments can be constructed in which actions are performed in a different order than those illustrated, and may include performing several actions simultaneously, even those shown as sequential in the illustrated embodiments.

[0127] At least some of the embodiments disclosed above (in particular, at least some of the disclosed methods / processes) can be implemented in circuits, computer hardware, firmware, software, and combinations thereof (e.g., computer systems). These computing systems may include PCs (which may include one or more peripherals well known in the art), smartphones, specially designed medical devices / apparatus, and / or other mobile / portable devices / apparatus. In some embodiments, the computer system is configured to include a client and a server. The client and server are typically geographically separated and typically interact via a communication network (e.g., VPN, Internet). The client-server relationship is established by means of computer programs running on the respective computers and having a client-server relationship with each other.

[0128] Some embodiments of this disclosure (e.g., the methods and processes disclosed above) can be implemented as computer programs / instructions executable and / or interpretable on a processor that can be connected to other devices (e.g., input devices and output devices / displays) that communicate via wireless or wired connections (e.g.).

[0129] All references made anywhere in this application to publications or other documents (including, but not limited to, patents, patent applications, articles, web pages, books, etc.) are incorporated herein by reference in their entirety. Furthermore, all definitions defined and used herein should be understood as controlling dictionary definitions, definitions in cited documents, and / or general definitions of defined terms.

[0130] The indefinite articles “a” and “an” used in the specification and claims herein shall be understood to mean “at least one” unless expressly stated to the contrary.

[0131] The phrase “and / or” as used herein in the specification and claims should be understood to mean “any one or both” of the elements so combined (i.e., elements that exist together in some cases and separately in others). Multiple elements listed with “and / or” should be interpreted in the same way, i.e., “one or more” of the elements so combined. Other elements may optionally be present, not specifically identified by the “and / or” clause, whether related to or unrelated to those specifically identified. Thus, as a non-limiting example, when used in conjunction with open-ended language such as “comprising,” a reference to “A and / or B” may in one embodiment refer to only A (optionally, including elements other than B); in another embodiment, only B (optionally, including elements other than B); in yet another embodiment, both A and B (optionally, including other elements), and so on.

[0132] As used herein in the specification and claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when the items in a list are separated, “or” or “and / or” should be interpreted as inclusive, i.e., including at least one element, but also including more than one element, several or a series of elements, and optionally, additional unlisted items. Terms that clearly indicate the opposite (such as “only one of” or “exact one of”) or, when used in the claims, “consisting of” will mean including exactly one element or several or a series of elements. In general, the term “or” as used herein, when preceding exclusive terms (such as “any one,” “one of,” “only one of,” or “exact one of”), is interpreted as indicating an exclusive alternative (i.e., “one or the other, but not both”). “Substantially consisting of”, when used in the claims, should have the same ordinary meaning as used in the field of patent law.

[0133] As used herein in the specification and claims, the phrase “at least one” referring to a series of one or more elements should be understood to mean at least one element selected from any one or more of this series of elements, but does not necessarily include at least one of each element specifically listed within this series of elements, and does not exclude any combination of elements within this series of elements. This definition also allows for the optional presence of elements other than those specifically identified within the series of elements referred to by the phrase “at least one,” whether related to or unrelated to those specifically identified elements. 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”) may in one embodiment mean at least one, optionally including more than one A, without B (and optionally including elements other than B); in another embodiment, mean at least one, optionally including more than one B, without A (and optionally including elements other than A); in yet another embodiment, mean at least one, optionally including more than one A, and at least one, optionally including more than one B (and optionally including other elements), etc.

[0134] In the claims and the above description, terms such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “reserving,” and “consisting of” will be understood as open-ended, meaning including but not limited to. Only the connecting phrases “consisting of” and “substantially consisting of” should be closed or semi-closed connecting phrases, respectively, as set forth in Section 2111.03 of the United States Patent Office Manual of Patent Examining Procedures.

Claims

1. A fluid delivery system for delivering fluid into a user's body, comprising: A disposable skin interface configured to establish contact with the body surface and to insert a cannula into the body; Portable infusion device, comprising: A disposable component comprising a first reservoir for fluid introduced into the user's body and a second reservoir with a plunger, and Reusable components, including: Actuation module; A first compartment, configured to accommodate a first storage unit; A second compartment, configured to accommodate a second storage unit; A gasket, used to seal the joint between the second reservoir and the second compartment when the reusable component and the disposable component are connected; and A vent, configured to ventilate the first compartment. The actuation module is configured as follows: The plunger is moved in the first direction to allow fluid to flow from the first reservoir to the second reservoir. The plunger is moved in the opposite direction to allow the fluid to flow from the second reservoir to the outlet of the portable fluid delivery device; and Establish fluid communication between the outlet of the portable fluid infusion device and the cannula inserted into the body to allow fluid to enter the body.

2. The system of claim 1, wherein the portable infusion device further comprises an electronic module that, together with the actuation module, operates the plunger to move in the first direction and the opposite direction.

3. The system according to claim 2, wherein the electronic module includes a sensor.

4. The system according to claim 3, wherein the sensor comprises one or more of a motion sensor, a power sensor, a bubble sensor, a rotation speed sensor, a blockage sensor, a first reservoir water level sensor, a second reservoir motion sensor, a second reservoir position sensor, and / or a plunger position sensor.

5. The system of claim 4, wherein the actuation module comprises an actuator and a lever.

6. The system of claim 5, wherein the lever is configured to be operably coupled to the plunger to drive displacement of the plunger and / or the second reservoir.

7. The system of claim 5, wherein the actuation module further comprises a rod coupling device connected to the rod and a plunger coupling device connected to the plunger.

8. The system of claim 7, wherein the connection between the rod coupling device and the plunger coupling device allows the rod to be operably coupled to the plunger.

9. The system of claim 7, wherein the connection between the rod connecting device and the plunger connecting device is mechanical and / or magnetic.

10. The system of claim 5, wherein when the plunger undergoes maximum displacement in the first direction, the distal end of the first reservoir aligns with or extends beyond the distal end of the rod.

11. The system of claim 1, wherein the reusable component includes an opening for receiving at least a portion of the disposable component.

12. The system of claim 2 or 3, wherein the reusable component comprises a housing and a spacer.

13. The system of claim 12, wherein the partition divides the reusable component into a first compartment and a second compartment.

14. The system of claim 13, wherein the first compartment comprises an electronic module and an actuation module.

15. The system of claim 1, wherein the actuation module comprises a motor and gears.

16. The system of claim 13, wherein the first compartment includes an opening having a circular or annular cross-sectional shape.

17. The system of claim 16, wherein when the reusable component and the disposable component are connected, the gasket is configured to watertightly seal the first compartment.

18. The system of claim 13, wherein the second compartment includes an opening having a non-circular cross-section.

19. The system of claim 1, wherein the reusable component comprises at least one sealed compartment.

20. The system of claim 1, wherein the second reservoir includes a dosing device configured to accurately dispense fluid to a user.

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