Apparatus, system, and method for injection pump assembly

Abstract

To provide apparatus, systems, and methods for injection pump assemblies. [Solution] A system for delivering a volume of injectable fluid. The system includes a controller configured to calculate a trajectory for delivering an injectable fluid, the trajectory including the volume of at least one fluid, and to determine a schedule for delivering the volume of the at least one fluid according to the trajectory, the schedule including intervals and volumes for delivering the injectable fluid. The system also includes a volume sensor assembly for determining the volume of at least one fluid to be delivered, and the controller recalculates the trajectory based on the volume of fluid to be delivered.

Description

[Technical Field]

[0001] (Citation of related applications) This application is a non-provisional application and is a result of U.S. Provisional Patent Application No. 61 / 270,908 (filed July 15, 2009, title "Infusion Pump Assembly", attorney case number H34). That application is cited by reference in its entirety.

[0002] This application is also a continuation-in-part application of U.S. Patent Application No. 12 / 347,981 (filed December 31, 2008, U.S. Patent Application Publication US-2009-0275896-A1 (published November 5, 2009), title "Infusion Pump Assembly," attorney case number G77), which is cited by reference in its entirety. This application also claims priority under the following U.S. Provisional Patent Applications, all of which are cited herein by reference in their entirety: U.S. Provisional Patent Application No. 61 / 018,054 (filed December 31, 2007, title "Patch Pump with Shape Memory Wire Pump Actuator", attorney case number E87); U.S. Provisional Patent Application No. 61 / 018,042 (filed December 31, 2007, title "Patch Pump with External Infusion Set", attorney case number E88); U.S. Provisional Patent Application No. 61 / 017,989 (filed December 31, 2007, title "Wearable Infusion Pump with Disposable Base", attorney case number E89); U.S. Provisional Patent Application No. 61 / 018,002 (filed December 31, 2007, title "Patch Pump with Rotational Engagement Assembly", attorney case number E90); U.S. Provisional Patent Application No. 61 / 018,339 (filed December 31, 2007, title "System and Method for Controlling "a Shape-Memory Actuator", attorney case number E91); U.S. Provisional Patent Application No. 61 / 023,645 (filed January 25, 2008, title "Infusion Pump with Bolus Button", attorney case number F49); U.S. Provisional Patent Application No. 61 / 101,053 (filed July 29, 2008, title "Infusion Pump Assembly with a Switch Assembly", attorney case number F73); U.S. Provisional Patent Application No. 61 / 101,077 (filed September 29, 2008, title "Infusion Pump Assembly with a Tubing Storage", attorney case number F74); U.S. Provisional Patent Application No. 61 / 101,105 (filed September 29, 2008, title "Improved Infusion Pump" "Assembly", attorney case number F7S; and U.S. Provisional Patent Application No. 61 / 101,115 (filed September 29, 2008, title "Filling Apparatus and Methods for an Infusion Pump Assembly", attorney case number G08).

[0003] U.S. Patent Application No. 12 / 347,981 is also a continuation-in-part application of each of the following applications: U.S. Patent Application No. 11 / 704,899 (filed February 9, 2007, published US-2007-0228071-A1 (published October 4, 2007), title "Fluid Delivery Systems and Method", attorney case number E70); U.S. Patent Application No. 12 / 347,981 (filed February 9, 2007, published US-2007-0219496-A1 (published September 20, 2007), title "Pumping Fluid Delivery Systems and Methods Using Force Application Assembly", attorney case number 1062 / E71); U.S. Patent Application No. 11 / 704,886 (filed February 9, 2007, published US-2007-0219480-A1 (published September 20, 2007), title "Patch-Sized Fluid Delivery Systems and The following applications claim priority based on the following U.S. provisional patent applications, which are incorporated herein by reference in their entirety: U.S. Provisional Patent Application No. 60 / 772.313 (filed February 9, 2006, title "Portable Injection System", attorney case number 1062 / E42); U.S. Provisional Patent Application No. 60 / 789,243 (filed April 5, 2006, title "Method of Volume Measurement for Flow Control", attorney case number 1062 E53); and U.S. Provisional Patent Application No. 60 / 793,188 (filed April 19, 2006, title "Portable Injection and Adhesive System", attorney case number 1062 / E46). These applications are incorporated herein by reference in their entirety.

[0004] U.S. Patent Application No. 11 / 704,899 (filed February 9, 2007, published US-2007-0228071-A1 (published October 4, 2007), title "Fluid Delivery Systems and Method", attorney case number E70); U.S. Patent Application No. 12 / 347,981 (filed February 9, 2007, published US-2007-0219496-A1 (published September 20, 2007), title "Pumping Fluid Delivery Systems and Methods Using Force Application Assembly", attorney case number 1062 / E71); U.S. Patent Application No. 11 / 704,886 (filed February 9, 2007, published US-2007-0219480-A1 (published September 20, 2007), title "Patch-Sized Fluid Delivery Systems and The applications “Methods”, attorney case number 1062 / E72; and U.S. Patent Application No. 11 / 704,897 (filed February 9, 2007, published US-2007-0219597-A1 (published September 20, 2007), titled “Adhesive and Peripheral Systems and Methods for Medical Devices”, attorney case number 1062 / E73) are all related to each other and also to U.S. Provisional Patent Application No. 60 / 889,007 (filed February 9, 2007, titled “Two-Stage Transcutaneous Inserter”, attorney case number 1062 / E74). These applications are incorporated herein by reference in their entirety.

[0005] (Technical field) This application relates, in general, to fluid delivery systems, and more specifically, to apparatus, systems, and methods for injection pump assemblies. [Background technology]

[0006] Many potentially valuable drugs or compounds, including biological agents, are ineffective orally due to poor absorption, hepatic metabolism, or other pharmacokinetic factors. In addition, some therapeutic compounds, while absorbable orally, may require frequent administration, making it difficult for patients to maintain a desired schedule. In these cases, parenteral delivery is often employed or may be employed.

[0007] Effective parenteral routes for drug delivery, as well as for other fluids and compounds, include skin puncture with a needle or stylet, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration. Insulin is an example of a therapeutic fluid that is self-injected by millions of diabetic patients. Users of parenterally delivered drugs may benefit from wearable devices that automatically deliver the necessary drug compounds over a period of time.

[0008] To achieve this objective, efforts have been made to design portable and wearable devices for the controlled release of therapeutic drugs. Such devices are known to have a reservoir such as a cartridge, syringe, or bag, and to be electronically controlled. These devices have numerous drawbacks, including a high failure rate. Reducing the size, weight, and cost of these devices is also an ongoing challenge. In addition, these devices are often applied to the skin, which presents the challenge of frequent repositioning for application. [Overview of the project] [Means for solving the problem]

[0009] According to one aspect of the present invention, a system for delivering an injectable medical fluid is disclosed. The system includes a controller configured to calculate a trajectory for delivering an injectable fluid, the trajectory comprising the volume of at least one fluid, and to determine a schedule for delivering the volume of the at least one fluid according to the trajectory, the schedule comprising intervals and volumes for the delivery of the injectable fluid. The system also includes a volume sensor assembly for determining the volume of at least one fluid to be delivered, the controller recalculating the trajectory based on the volume of fluid to be delivered.

[0010] Some embodiments of this aspect of the present invention include one or more of the following: the trajectory is based on delivery commands received by a controller, the delivery commands include bolus and base commands, and / or the system includes a pump. In some embodiments where the system includes a pump, the system may also include one or more of the following: the schedule is determined based on the maximum pulse capacity of the pump, the schedule is determined based on the minimum pulse capacity of the pump, the schedule is determined based on the power consumption of the pump, the schedule is determined based on the minimum pulse interval of the pump. In some embodiments, the system may include schedules with equal injectable fluid capacities.

[0011] According to one aspect of the present invention, a medical infusion device for delivering an injectable medical fluid is disclosed. The device includes a pump having minimum and maximum pulse capacities, and a controller configured to determine a first volume of the injectable medical fluid to be delivered, and, based on the first volume of the injectable medical fluid to be delivered, to determine the time and volume for delivering a second volume of the injectable fluid.

[0012] Some embodiments of this aspect of the present invention include one or more of the following: the injection device further comprises a disposable housing assembly and a reusable housing assembly, the reusable housing assembly further comprises a locking ring assembly, the reusable housing assembly releasably engages the disposable housing assembly via the locking ring assembly, the locking ring assembly comprises a spring, a tab connected to the spring, and a magnet connected to the tab. The disposable housing assembly further comprises a reservoir, a pump accomplishes the transfer of an injectable medical fluid from the reservoir to a volume sensor assembly, the pump is driven by a shape memory alloy, the injection pump further comprises a split ring resonator antenna, the device further comprises a volume sensor assembly for determining a first volume and a second volume of the injectable medical fluid to be delivered, and / or the volume sensor assembly comprises an acoustically continuous region having a volume that varies based on the amount of injectable fluid received from the reservoir, and an acoustic energy emitter configured to provide acoustic energy at multiple frequencies to excite a gas contained in the acoustically continuous region.

[0013] According to one aspect of the present invention, a controller for a medical infusion device for delivering medical fluids is disclosed. The controller includes a volume sensor assembly for determining a first volume of injectable fluid to be delivered; a processor for determining the difference between a desired first volume of injectable fluid to be delivered and an actual first volume of injectable fluid to be delivered; and a processor for determining a schedule and volume for delivering a second volume of injectable fluid based on the difference.

[0014] Some embodiments of this aspect of the present invention include one or more of the following: a capacity sensor assembly having an acoustically continuous region having a capacity that varies based on the amount of injectable fluid received from a reservoir, and an acoustic energy emitter configured to excite a gas contained in the acoustically continuous region by providing acoustic energy at multiple frequencies.

[0015] According to another implementation, a mounted injection pump assembly includes a reservoir for receiving an injectable fluid and a fluid delivery system configured to deliver the injectable fluid from the reservoir to an external injection set. The fluid delivery system includes a volume sensor assembly configured to receive a volume of injectable fluid from the reservoir. The volume sensor assembly includes an acoustically continuous region having a volume that varies based on the volume of injectable fluid received from the reservoir. The volume sensor assembly further includes an acoustic energy emitter configured to provide acoustic energy at multiple frequencies to excite a gas contained within the acoustically continuous region.

[0016] The capacitive sensor assembly may include one or more of the following features: The capacitive sensor assembly may further include a first acoustic energy receptor for receiving at least a portion of the acoustic energy provided by the acoustic energy emitter and for defining the acoustic response for each of a plurality of frequencies. A second acoustic energy receptor may receive at least a portion of the acoustic energy provided by the acoustic energy emitter and define the acoustic reference for each of a plurality of frequencies.

[0017] The acoustically continuous region may include a variable-volume chamber having a volume that varies based on the amount of injectable fluid received from the reservoir. The acoustically continuous region may also include at least one fixed-volume chamber having a volume that remains constant regardless of the amount of injectable fluid received from the reservoir. At least one acoustic port may acoustically couple the variable-volume chamber to at least one fixed-volume chamber.

[0018] The first acoustic energy receptor may be a constant microphone positioned in close proximity to a variable capacitance chamber. The second acoustic energy receptor may be a reference microphone positioned in close proximity to at least one fixed capacitance chamber.

[0019] The wearable infusion pump assembly may further include at least one processor and a computer-readable medium coupled to the at least one processor. The computer-readable medium may include a plurality of instructions stored thereon. When executed by the at least one processor, the instructions may cause the at least one processor to perform operations including determining a phase relationship between an acoustic response and a reference for each of a plurality of frequencies. The computer-readable medium may further include instructions for calculating a change in capacitance characteristics based at least in part on the phase relationship between the acoustic response and the acoustic reference for each of the plurality of frequencies.

[0020] The wearable infusion pump assembly may further include a disposable housing assembly that may include a reservoir and a first portion of the fluid delivery system. The wearable infusion pump assembly may also include a reusable housing assembly that may include a second portion of the fluid delivery system. The first portion of the pump assembly may be positioned within the disposable housing assembly. The second portion of the pump assembly may be positioned within the reusable housing assembly. The pump assembly may be configured to extract a volume of injectable fluid from the reservoir and provide the volume of injectable fluid to a capacitance sensor assembly.

[0021] A first portion of the first valve assembly may be positioned within the disposable housing assembly. A second portion of the first valve assembly may be positioned within the reusable housing assembly. The first valve assembly may be configured to selectively isolate the pump assembly from the reservoir. A first portion of the second valve assembly may be positioned within the disposable housing assembly. A second portion of the second valve assembly may be positioned within the reusable housing assembly. The second valve assembly may be configured to selectively isolate the capacitance sensor assembly from an external injection set.

[0022] According to another implementation, the wearable infusion pump assembly includes a reservoir for receiving the injectable fluid and a fluid delivery system configured to deliver the injectable fluid from the reservoir to an external infusion set. The fluid delivery system includes a volume sensor assembly configured to receive a quantity of the injectable fluid from the reservoir. The wearable infusion pump assembly also includes at least one processor and a computer-readable medium coupled to the at least one processor. The computer-readable medium includes a plurality of instructions stored thereon. When executed by the at least one processor, the instructions cause the at least one processor to perform operations including calculating a first volume characteristic before providing a quantity of the injectable fluid to the external infusion set. The computer-readable medium also includes instructions for calculating a second volume characteristic after providing the quantity of the injectable fluid to the external infusion set. The computer-readable medium further includes instructions for determining whether an occlusion condition has occurred.

[0023] One or more of the following features may be included. The instructions for determining whether an occlusion condition has occurred may include instructions for calculating a volume difference from the first volume characteristic and the second volume characteristic. The instructions for determining whether an occlusion condition has occurred may also include instructions for analyzing the volume difference to determine whether an occlusion condition has occurred.

[0024] According to another implementation, a mounted injection pump assembly includes a reservoir for receiving an injectable fluid and a fluid delivery system configured to deliver the injectable fluid from the reservoir to an external injection set. The fluid delivery system includes a volume sensor assembly configured to receive the volume of the injectable fluid from the reservoir. The fluid delivery system further includes at least one processor and a computer-readable medium coupled to at least one processor. The computer-readable medium includes a number of instructions stored thereon. When executed by at least one processor, the instructions cause at least one processor to perform an operation that includes determining the volume of the injectable fluid to be delivered to the user via the external injection set. The computer-readable medium also includes instructions for comparing the volume of the injectable fluid to be delivered with a target delivery volume to determine the volume difference. The computer-readable medium further includes instructions for adjusting subsequent delivery volumes of the injectable fluid to offset the volume difference.

[0025] One or more of the following characteristics may be present: A volume difference may indicate over-delivery. The amount delivered after the injectable fluid may be reduced by the volume difference. A volume difference may indicate under-delivery. The amount delivered after the injectable fluid may be increased by the volume difference.

[0026] According to yet another implementation, the mounted injection pump assembly includes a reusable housing assembly and a disposable housing assembly that includes a reservoir for receiving the injectable fluid. A releasable engagement assembly is configured to allow a reusable housing assembly to releasably engage a disposable housing assembly. The mounted injection assembly also includes at least one processor and a computer-readable medium linked to at least one processor. The computer-readable medium includes a plurality of instructions stored thereon. When executed by at least one processor, the instructions cause at least one processor to perform an operation which includes executing one or more hierarchical state machines to achieve the delivery of one or more bolus injection events.

[0027] According to yet another implementation, the mounted injection pump assembly includes a reusable housing assembly and a disposable housing assembly that includes a reservoir for receiving the injectable fluid. The releasable engagement assembly is configured to allow a reusable housing assembly to releasably engage a disposable housing assembly. The mounted injection pump assembly also includes at least one processor and a computer-readable medium coupled to the at least one processor. The computer-readable medium includes a plurality of instructions stored thereon. When executed by the at least one processor, the instructions cause the at least one processor to perform an operation which includes executing one or more hierarchical state machines to achieve the delivery of one or more underlying injection events.

[0028] According to yet another implementation, the mounted injection pump assembly includes a reusable housing assembly and a disposable housing assembly that includes a reservoir for receiving the injectable fluid. The releasable engagement assembly is configured to allow a reusable housing assembly to releasably engage a disposable housing assembly. The mounted injection pump assembly further includes at least one processor and a computer-readable medium coupled to at least one processor. The computer-readable medium includes a plurality of instructions stored thereon. When executed by at least one processor, the instructions cause at least one processor to perform an operation which includes executing one or more hierarchical state machines to achieve the execution of one or more blockage detection events.

[0029] According to yet another implementation, the mounted injection pump assembly includes a reusable housing assembly and a disposable housing assembly that includes a reservoir for receiving the injectable fluid. A releasable engagement assembly is configured to allow a reusable housing assembly to releasably engage a disposable housing assembly. The mounted injection pump assembly further includes at least one processor and a computer-readable medium coupled to at least one processor. The computer-readable medium includes a plurality of instructions stored thereon. When executed by at least one processor, the instructions cause at least one processor to perform an operation which includes executing one or more hierarchical state machines to achieve the execution of one or more paired events.

[0030] According to yet another implementation, the mounted injection pump assembly includes a reusable housing assembly and a disposable housing assembly that includes a reservoir for receiving the injectable fluid. A releasable engagement assembly is configured to allow a reusable housing assembly to releasably engage with a disposable housing assembly. The mounted injection pump assembly further includes a filling station which includes a supply of injectable fluid. The filling station is configured to releasably fluid-connect the reservoir and to achieve delivery of injectable fluid from the filling station to the reservoir.

[0031] Details of one or more embodiments will be described in the accompanying drawings and description below. Other features and advantages will be evident from the description, drawings, and claims. The present invention provides, for example, the following items: (Item 1) A system for delivering a volume of injectable fluid, It is a controller, The calculation of a trajectory for delivering an injectable fluid, wherein the trajectory includes the volume of at least one fluid. Determining a schedule for delivering the volume of the at least one fluid according to the trajectory, the schedule including intervals and volumes for the delivery of the injectable fluid. A controller configured to perform the following actions: A capacity sensor assembly for determining the volume of at least one fluid to be delivered, Equipped with, The controller recalculates the trajectory based on the volume of the fluid being delivered. system. (Item 2) The system described in item 1, wherein the trajectory is based on a delivery command received by the controller. (Item 3) The delivery command is the system described in item 1, including a bolus and a base command. (Item 4) The system described in item 1, which also includes a pump. (Item 5) The system described in item 4, wherein the schedule is determined based on the maximum pulse capacity of the pump. (Item 6) The system described in item 4, wherein the schedule is determined based on the minimum pulse capacity of the pump. (Item 7) The system described in item 4, wherein the schedule is determined based on the power consumption of the pump. (Item 8) The system described in item 4, wherein the schedule is determined based on the minimum pulse interval of the pump. (Item 9) The aforementioned schedule is for the system described in item 1, including equal injectable fluid volumes. (Item 10) A medical infusion device for delivering injectable medical fluids, A pump having minimum and maximum pulse capacity, It is a controller, To determine the first volume of the injectable medical fluid to be delivered, Based on the first volume of the injectable medical fluid to be delivered, the time and volume for the delivery of the second volume of the injectable fluid are determined. A controller configured to perform the following actions It is equipped with Medical infusion device. (Item 11) The medical infusion device according to item 10, further comprising a disposable housing assembly and a reusable housing assembly. (Item 12) The medical infusion device according to item 10, wherein the reusable housing assembly further comprises a locking ring assembly, the reusable housing assembly releasably engaging the disposable housing assembly via the locking ring assembly. (Item 13) The aforementioned locking ring assembly is Springs and, A tab that connects to the spring, A magnet to connect to the tab and A medical infusion device as described in item 12, which is equipped with the following: (Item 14) The medical infusion device according to item 11, wherein the disposable housing assembly further comprises a storage section, and the pump moves a medical fluid that can be injected from the storage section to a volume sensor assembly. (Item 15) The pump is a medical infusion device according to item 10, driven by a shape memory alloy. (Item 16) The medical infusion device according to item 10, wherein the infusion pump further comprises a split-ring resonator antenna. (Item 17) The medical infusion device according to item 10, further comprising a volume sensor assembly for determining the first and second volumes of the injectable medical fluid to be delivered. (Item 18) The aforementioned capacitance sensor assembly is An acoustically continuous region having a capacity that varies based on the amount of injectable fluid received from the storage section, An acoustic energy emitter configured to provide acoustic energy at multiple frequencies in order to excite the gas contained in the acoustically continuous region, A medical infusion device as described in item 17, which is equipped with the following: (Item 19) A controller for a medical infusion device that delivers medical fluids, A capacity sensor assembly for determining the first volume of the injectable fluid to be delivered, A processor for determining the difference between a desired first volume of injectable fluid to be delivered and the actual first volume of injectable fluid delivered, A processor for determining the schedule and capacity for delivering a second volume of injectable fluid based on the difference. A controller equipped with this feature. (Item 20) The aforementioned capacitance sensor assembly is An acoustically continuous region having a volume that varies based on the amount of injectable fluid received from the reservoir, An acoustic energy emitter configured to provide acoustic energy at multiple frequencies in order to excite the gas contained in the acoustically continuous region, A controller as described in item 19, which is equipped with the following features. [Brief explanation of the drawing]

[0032] [Figure 1] Figure 1 is a side view of the injection pump assembly. [Figure 2] Figure 2 is a perspective view of the injection pump assembly shown in Figure 1. [Figure 3] Figure 3 is an exploded view of the various components of the injection pump assembly shown in Figure 1. [Figure 4] Figure 4 is a cross-sectional view of the disposable housing assembly of the injection pump assembly shown in Figure 1. [Figure 5A] Figures 5A to 5C are cross-sectional views of an embodiment of a bulkhead access assembly. [Figure 5B] Figures 5A to 5C are cross-sectional views of an embodiment of a bulkhead access assembly. [Figure 5C] Figures 5A to 5C are cross-sectional views of an embodiment of a bulkhead access assembly. [Figure 6A]Figures 6A-6B are cross-sectional views of another embodiment of the bulkhead access assembly. [Figure 6B] Figures 6A-6B are cross-sectional views of another embodiment of the bulkhead access assembly. [Figure 7A] Figures 7A–7B are partial top views of another embodiment of the bulkhead access assembly. [Figure 7B] Figures 7A–7B are partial top views of another embodiment of the bulkhead access assembly. [Figure 8A] Figures 8A-8B are cross-sectional views of another embodiment of the bulkhead access assembly. [Figure 8B] Figures 8A-8B are cross-sectional views of another embodiment of the bulkhead access assembly. [Figure 9] Figure 9 is a perspective view of the injection pump assembly from Figure 1, showing the external injection set. [Figure 10A] Figures 10A to 10E illustrate multiple Velcro (registered trademark) configurations. [Figure 10B] Figures 10A to 10E illustrate multiple Velcro (registered trademark) configurations. [Figure 10C] Figures 10A to 10E illustrate multiple Velcro (registered trademark) configurations. [Figure 10D] Figures 10A to 10E illustrate multiple Velcro (registered trademark) configurations. [Figure 10E] Figures 10A to 10E illustrate multiple Velcro (registered trademark) configurations. [Figure 11A] Figure 11A is an isometric view of an alternative embodiment of the remote control assembly and the injection pump assembly shown in Figure 1. [Figure 11B] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11C] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11D]Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11E] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11F] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11G] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11H] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11I] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11J] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11K] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11L] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11M] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11N] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11O] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11P] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11Q] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11R] Figures 11B–11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 12] Figures 12A to 12F are multiple display screens rendered by the remote control assembly shown in Figure 11A. [Figure 13] Figure 13 is an isometric view of an alternative embodiment of the injection pump assembly shown in Figure 1. [Figure 14] Figure 14 is an isometric view of the injection pump assembly shown in Figure 13. [Figure 15] Figure 15 is an isometric view of the injection pump assembly shown in Figure 13. [Figure 16] Figure 16 is an isometric view of an alternative embodiment of the injection pump assembly shown in Figure 1. [Figure 17] Figure 17 is a plan view of the injection pump assembly shown in Figure 16. [Figure 18] Figure 18 is a plan view of the injection pump assembly shown in Figure 16. [Figure 19A] Figure 19A is an exploded view of the various components of the injection pump assembly shown in Figure 16. [Figure 19B] Figure 19B is an isometric view of a portion of the injection pump assembly shown in Figure 16. [Figure 20] Figure 20 is a cross-sectional view of the disposable housing assembly of the injection pump assembly shown in Figure 16. [Figure 21] Figure 21 is a diagram of the fluid path within the injection pump assembly shown in Figure 16. [Figure 22A] Figures 22A to 22C are diagrams of the fluid pathways within the injection pump assembly shown in Figure 16. [Figure 22B] Figures 22A to 22C are diagrams of the fluid pathways within the injection pump assembly shown in Figure 16. [Figure 22C] Figures 22A to 22C are diagrams of the fluid pathways within the injection pump assembly shown in Figure 16. [Figure 23]Figure 23 is an exploded view of the various components of the injection pump assembly shown in Figure 16. [Figure 24] Figure 24 is a cross-sectional isometric view of the injection pump assembly shown in Figure 16. [Figure 25A] Figures 25A to 25D are other isometric views of the pump assembly shown in Figure 24. [Figure 25B] Figures 25A to 25D are other isometric views of the pump assembly shown in Figure 24. [Figure 25C] Figures 25A to 25D are other isometric views of the pump assembly shown in Figure 24. [Figure 25D] Figures 25A to 25D are other isometric views of the pump assembly shown in Figure 24. [Figure 26A] Figures 26A to 26B are isometric views of the measuring valve assembly of the injection pump assembly shown in Figure 16. [Figure 26B] Figures 26A to 26B are isometric views of the measuring valve assembly of the injection pump assembly shown in Figure 16. [Figure 27A] Figures 27A to 27B are side views of the measuring valve assembly shown in Figures 26A to 26B. [Figure 27B] Figures 27A to 27B are side views of the measuring valve assembly shown in Figures 26A to 26B. [Figure 28A] Figures 28A to 28D show the measurement valve assembly of the injection pump assembly shown in Figure 16. [Figure 28B] Figures 28A to 28D show the measurement valve assembly of the injection pump assembly shown in Figure 16. [Figure 28C] Figures 28A to 28D show the measurement valve assembly of the injection pump assembly shown in Figure 16. [Figure 28D] Figures 28A to 28D show the measurement valve assembly of the injection pump assembly shown in Figure 16. [Figure 29] Figure 29 is an isometric view of an alternative embodiment of the injection pump assembly shown in Figure 1. [Figure 30] Figure 30 is an isometric view of an alternative embodiment of the injection pump assembly shown in Figure 1. [Figure 31]Figure 31 is another diagram of an alternative embodiment of the injection pump assembly shown in Figure 9. [Figure 32] Figure 32 is an exploded view of another embodiment of the injection pump assembly. [Figure 33] Figure 33 is another exploded view of the injection pump assembly shown in Figure 32. [Figure 34A] Figures 34A-34B depict another embodiment of the injection pump assembly. [Figure 34B] Figures 34A-34B depict another embodiment of the injection pump assembly. [Figure 35A] Figures 35A to 35C are top, side, and bottom views of the reusable housing assembly of the injection pump assembly shown in Figure 32. [Figure 35B] Figures 35A to 35C are top, side, and bottom views of the reusable housing assembly of the injection pump assembly shown in Figure 32. [Figure 35C] Figures 35A to 35C are top, side, and bottom views of the reusable housing assembly of the injection pump assembly shown in Figure 32. [Figure 36] Figure 36 is an exploded view of the reusable housing assembly shown in Figures 35A to 35C. [Figure 37] Figure 37 is an exploded view of the reusable housing assembly shown in Figures 35A to 35C. [Figure 38A] Figure 38A is an exploded view of the reusable housing assembly shown in Figures 35A-35C. [Figure 38B] Figures 38B to 38D are a top view, side view, and bottom view of one embodiment of a dust cover. [Figure 38C] Figures 38B to 38D are a top view, side view, and bottom view of one embodiment of a dust cover. [Figure 38D] Figures 38B to 38D are a top view, side view, and bottom view of one embodiment of a dust cover. [Figure 39A] Figures 39A–39C are top, side, and bottom views of the electrical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 39B] Figures 39A–39C are top, side, and bottom views of the electrical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 39C] Figures 39A–39C are top, side, and bottom views of the electrical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 40A] Figures 40A to 40C are the top, side, and bottom views of the circuit board of the reusable enclosure assembly shown in Figures 35A to 35C. [Figure 40B] Figures 40A to 40C are the top, side, and bottom views of the circuit board of the reusable enclosure assembly shown in Figures 35A to 35C. [Figure 40C] Figures 40A to 40C are the top, side, and bottom views of the circuit board of the reusable enclosure assembly shown in Figures 35A to 35C. [Figure 41A] Figures 41A to 41B are perspective top and bottom views of the substrate shown in Figures 40A to 40C. [Figure 41B] Figures 41A to 41B are perspective top and bottom views of the substrate shown in Figures 40A to 40C. [Figure 42A] Figures 42A to 42C are the top, side, and bottom views of the circuit board of the reusable enclosure assembly shown in Figures 35A to 35C. [Figure 42B] Figures 42A to 42C are the top, side, and bottom views of the circuit board of the reusable enclosure assembly shown in Figures 35A to 35C. [Figure 42C] Figures 42A to 42C are the top, side, and bottom views of the circuit board of the reusable enclosure assembly shown in Figures 35A to 35C. [Figure 43A] Figures 43A–43B depict the mechanical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 43B] Figures 43A–43B depict the mechanical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 44A] Figures 44A–44C depict the mechanical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 44B] Figures 44A–44C depict the mechanical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 44C] Figures 44A–44C depict the mechanical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 45A] Figures 45A–45B depict the pump plunger and reservoir valve of the mechanical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 45B] Figures 45A–45B depict the pump plunger and reservoir valve of the mechanical control assembly of the reusable housing assembly shown in Figures 35A–35C. [Figure 46A] Figures 46A–46E depict the plunge pumper and reservoir valve of the mechanical control assembly for the reusable housing assembly shown in Figures 35A–35C. [Figure 46B] Figures 46A–46E depict the plunge pumper and reservoir valve of the mechanical control assembly for the reusable housing assembly shown in Figures 35A–35C. [Figure 46C] Figures 46A–46E depict the plunge pumper and reservoir valve of the mechanical control assembly for the reusable housing assembly shown in Figures 35A–35C. [Figure 46D] Figures 46A–46E depict the plunge pumper and reservoir valve of the mechanical control assembly for the reusable housing assembly shown in Figures 35A–35C. [Figure 46E] Figures 46A–46E depict the plunge pumper and reservoir valve of the mechanical control assembly for the reusable housing assembly shown in Figures 35A–35C. [Figure 47A] Figures 47A–47B depict the measuring valves of the mechanical control assembly in the reusable housing assembly shown in Figures 35A–35C. [Figure 47B] Figures 47A–47B depict the measuring valves of the mechanical control assembly in the reusable housing assembly shown in Figures 35A–35C. [Figure 48] Figure 48 is an exploded view of the disposable housing assembly of the injection pump assembly shown in Figure 32. [Figure 49A] Figure 49A is a plan view of the disposable housing assembly shown in Figure 48. [Figure 49B] Figure 49B is a cross-sectional view of the disposable housing assembly of Figure 49A, obtained along line BB. [Figure 49C] Figure 49C is a cross-sectional view of the disposable housing assembly of Figure 49A, obtained along line CC. [Figure 50A] Figures 50A to 50C depict the basic components of the disposable housing assembly shown in Figure 48. [Figure 50B] Figures 50A to 50C depict the basic components of the disposable housing assembly shown in Figure 48. [Figure 50C] Figures 50A to 50C depict the basic components of the disposable housing assembly shown in Figure 48. [Figure 51A] Figures 51A-51C illustrate the fluid pathways of the disposable housing assembly shown in Figure 48. [Figure 51B] Figures 51A-51C illustrate the fluid pathways of the disposable housing assembly shown in Figure 48. [Figure 51C] Figures 51A-51C illustrate the fluid pathways of the disposable housing assembly shown in Figure 48. [Figure 52A] Figures 52A-52C depict the membrane assembly of the disposable housing assembly shown in Figure 48. [Figure 52B] Figures 52A-52C depict the membrane assembly of the disposable housing assembly shown in Figure 48. [Figure 52C] Figures 52A-52C depict the membrane assembly of the disposable housing assembly shown in Figure 48. [Figure 53A] Figures 53A–53C depict the top portion of the disposable housing assembly shown in Figure 48. [Figure 53B] Figures 53A–53C depict the top portion of the disposable housing assembly shown in Figure 48. [Figure 53C] Figures 53A–53C depict the top portion of the disposable housing assembly shown in Figure 48. [Figure 54A]Figures 54A–54C depict the valve inserts of the disposable housing assembly shown in Figure 48. [Figure 54B] Figures 54A–54C depict the valve inserts of the disposable housing assembly shown in Figure 48. [Figure 54C] Figures 54A–54C depict the valve inserts of the disposable housing assembly shown in Figure 48. [Figure 55A] Figures 55A-55B depict the locking ring assembly of the injection pump assembly shown in Figure 32. [Figure 55B] Figures 55A-55B depict the locking ring assembly of the injection pump assembly shown in Figure 32. [Figure 56] Figures 56A–56C depict the locking ring assembly of the injection pump assembly shown in Figure 32. [Figure 57] Figures 57-58 are isometric views of the injection pump assembly and filling adapter. [Figure 58] Figures 57-58 are isometric views of the injection pump assembly and filling adapter. [Figure 59] Figures 59-64 are various diagrams of the filling adapter shown in Figure 57. [Figure 60] Figures 59-64 are various diagrams of the filling adapter shown in Figure 57. [Figure 61] Figures 59-64 are various diagrams of the filling adapter shown in Figure 57. [Figure 62] Figures 59-64 are various diagrams of the filling adapter shown in Figure 57. [Figure 63] Figures 59-64 are various diagrams of the filling adapter shown in Figure 57. [Figure 64] Figures 59-64 are various diagrams of the filling adapter shown in Figure 57. [Figure 65] Figure 65 is an isometric view of another embodiment of the filling adapter. [Figure 66] Figures 66-67 illustrate another embodiment of the injection pump assembly and filling adapter. [Figure 67] Figures 66-67 illustrate another embodiment of the injection pump assembly and filling adapter. [Figure 68] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 69] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 70] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 71] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 72] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 73] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 74] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 75] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 76] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 77] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 78] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 79] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 80] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 81] Figures 81-89 illustrate various embodiments of the battery charger / docking station. [Figure 82] Figures 81-89 illustrate various embodiments of the battery charger / docking station. [Figure 83] Figures 81-89 illustrate various embodiments of the battery charger / docking station. [Figure 84] Figures 81-89 illustrate various embodiments of the battery charger / docking station. [Figure 85]Figures 81-89 illustrate various embodiments of the battery charger / docking station. [Figure 86] Figures 81-89 illustrate various embodiments of the battery charger / docking station. [Figure 87] Figures 81-89 illustrate various embodiments of the battery charger / docking station. [Figure 88] Figures 81-89 illustrate various embodiments of the battery charger / docking station. [Figure 89] Figures 81-89 illustrate various embodiments of the battery charger / docking station. [Figure 90A] Figures 90A to 90C show various diagrams of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 90B] Figures 90A to 90C show various diagrams of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 90C] Figures 90A to 90C show various diagrams of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 91A] Figures 91A to 91I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 91B] Figures 91A to 91I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 91C] Figures 91A to 91I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 91D] Figures 91A to 91I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 91E] Figures 91A to 91I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 91F] Figures 91A to 91I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 91G]Figures 91A to 91I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 91H] Figures 91A to 91I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 91I] Figures 91A to 91I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 92A] Figures 92A to 92I show various diagrams of the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 92B] Figures 92A to 92I show various diagrams of the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 92C] Figures 92A to 92I show various diagrams of the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 92D] Figures 92A to 92I show various diagrams of the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 92E] Figures 92A to 92I show various diagrams of the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 92F] Figures 92A to 92I show various diagrams of the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 92G] Figures 92A to 92I show various diagrams of the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 92H] Figures 92A to 92I show various diagrams of the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 92I] Figures 92A to 92I show various diagrams of the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 93A] Figures 93A to 93I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 93B]Figures 93A to 93I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 93C] Figures 93A to 93I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 93D] Figures 93A to 93I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 93E] Figures 93A to 93I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 93F] Figures 93A to 93I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 93G] Figures 93A to 93I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 93H] Figures 93A to 93I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 93I] Figures 93A to 93I show various diagrams of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 94A] Figures 94A to 94F show various diagrams of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 94B] Figures 94A to 94F show various diagrams of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 94C] Figures 94A to 94F show various diagrams of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 94D] Figures 94A to 94F show various diagrams of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 94E] Figures 94A to 94F show various diagrams of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 94F]Figures 94A to 94F show various diagrams of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 95] Figure 95 is an exploded view of the volume sensor assembly contained within the injection pump assembly shown in Figure 1. [Figure 96] Figure 96 is a diagram of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 97] Figure 97 is a two-dimensional graph of the performance characteristics of the capacitive sensor assembly shown in Figure 96. [Figure 98] Figure 98 is a two-dimensional graph of the performance characteristics of the capacitive sensor assembly shown in Figure 96. [Figure 99] Figure 99 is a two-dimensional graph of the performance characteristics of the capacitive sensor assembly shown in Figure 96. [Figure 100] Figure 100 is a diagram of the volume sensor assembly included in the injection pump assembly of Figure 1. [Figure 101] Figure 101 is a two-dimensional graph of the performance characteristics of the capacitive sensor assembly shown in Figure 100. [Figure 102] Figure 102 is a two-dimensional graph of the performance characteristics of the capacitive sensor assembly shown in Figure 100. [Figure 103] Figure 103 is a diagram of the volume sensor assembly included within the injection pump assembly in Figure 1. [Figure 104] Figure 104 is a two-dimensional graph of the performance characteristics of the capacity sensor assembly contained within the injection pump assembly in Figure 1. [Figure 105] Figure 105 is a two-dimensional graph of the performance characteristics of the capacity sensor assembly contained within the injection pump assembly in Figure 1. [Figure 106] Figure 106 is a two-dimensional graph of the performance characteristics of the capacity sensor assembly contained within the injection pump assembly in Figure 1. [Figure 107] Figure 107 is a two-dimensional graph of the performance characteristics of the capacity sensor assembly contained within the injection pump assembly in Figure 1. [Figure 108]Figure 108 is a two-dimensional graph of the performance characteristics of the capacity sensor assembly contained within the injection pump assembly in Figure 1. [Figure 109] Figure 109 is a diagram of the control model of the capacity sensor assembly contained within the injection pump assembly in Figure 1. [Figure 110] Figure 110 is a diagram of the electrical control assembly of the capacitive sensor assembly contained within the injection pump assembly in Figure 1. [Figure 111] Figure 111 is a diagram of the capacity controller of the capacity sensor assembly included in the injection pump assembly of Figure 1. [Figure 112] Figure 112 is a diagram of the forward feed controller of the capacitance controller shown in Figure 111. [Figure 113] Figures 113-114 schematically illustrate the implementation of the SMA controller for the capacitance controller shown in Figure 111. [Figure 114] Figures 113-114 schematically illustrate the implementation of the SMA controller for the capacitance controller shown in Figure 111. [Figure 114A] Figures 114A to 114B show alternative implementations of the SMA controller. [Figure 114B] Figures 114A to 114B show alternative implementations of the SMA controller. [Figure 115] Figure 115 schematically illustrates a multiprocessor control configuration that may be included within the injection pump assembly in Figure 1. [Figure 116] Figure 116 is a diagram of a multiprocessor control configuration that may be included within the injection pump assembly of Figure 1. [Figure 117A] Figures 117A to 117B schematically illustrate the multiprocessor functionality. [Figure 117B] Figures 117A to 117B schematically illustrate the multiprocessor functionality. [Figure 118] Figure 118 schematically illustrates the functionality of multiprocessors. [Figure 119] Figure 119 schematically illustrates the multiprocessor functionality. [Figure 120A]Figure 120A graphically depicts various software layers. [Figure 120B] Figures 120B to 120C illustrate various state diagrams. [Figure 120C] Figures 120B to 120C illustrate various state diagrams. [Figure 120D] Figure 120D graphically illustrates the device interaction. [Figure 120E] Figure 120E graphically depicts the device interaction. [Figure 121] Figure 121 schematically depicts the capacity sensor assembly included within the injection pump assembly in Figure 1. [Figure 122] Figure 122 schematically illustrates the interconnections of the various systems in the injection pump assembly shown in Figure 1. [Figure 123] Figure 123 schematically illustrates the basal bolus injection event. [Figure 124] Figure 124 schematically illustrates the basal bolus injection event. [Figure 125A] Figures 125A to 125G illustrate a hierarchical state machine. [Figure 125B] Figures 125A to 125G illustrate a hierarchical state machine. [Figure 125C] Figures 125A to 125G illustrate a hierarchical state machine. [Figure 125D] Figures 125A to 125G illustrate a hierarchical state machine. [Figure 125E] Figures 125A to 125G illustrate a hierarchical state machine. [Figure 125F] Figures 125A to 125G illustrate a hierarchical state machine. [Figure 125G] Figures 125A to 125G illustrate a hierarchical state machine. [Figure 126A] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126B] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126C] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126D] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126E] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126F] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126G] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126H] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126I] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126J] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126K] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126L] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 126M] Figures 126A to 126M illustrate a hierarchical state machine. [Figure 127] Figure 127 is a schematic diagram illustrating a split-ring resonator antenna. [Figure 128] Figure 128 is a schematic diagram illustrating an example of a medical device configured to utilize a split-ring resonator antenna. [Figure 129] Figure 129 is an illustrative schematic diagram of a split-ring resonator antenna and a transmission line from a medical injection device. [Figure 130] Figure 130 is a graph of the return loss of a split-ring resonator antenna before it comes into contact with human skin. [Figure 130A] Figure 130A is a graph of the return loss of a split-ring resonator antenna while it is in contact with human skin. [Figure 131] Figure 131 is an illustrative schematic diagram of a segmented ring resonator antenna integrated into a device operating in close proximity within a dielectric material. [Figure 132] Figure 132 is a schematic diagram showing the internal and external dimensions of an exemplary embodiment. [Figure 133] Figure 133 is a graph of the return loss of an undivided ring resonator antenna before contact with human skin. [Figure 133A] Figure 133A is a graph of the return loss of an undivided ring resonator antenna in contact with human skin. [Figure 199A] Figures 199A–199D depict the locking ring assembly of the injection pump assembly. [Figure 199B] Figures 199A–199D depict the locking ring assembly of the injection pump assembly. [Figure 199C] Figures 199A–199D depict the locking ring assembly of the injection pump assembly. [Figure 199D] Figures 199A–199D depict the locking ring assembly of the injection pump assembly. [Figure 200-1] Figure 200B is a cross-sectional view of one embodiment of the disposable housing assembly of Figure 200A, obtained along line BB. [Figure 200-2] Figure 200D is a cross-sectional view of one embodiment of the disposable housing assembly of Figure 200C, obtained along line BB. [Figure 200-3] Figure 200E is a cross-sectional view of one embodiment of the disposable housing assembly of Figure 200F, obtained along line EE. [Figure 200-4] Figure 200H is a cross-sectional view of one embodiment of the disposable housing assembly of Figure 200G, obtained along line HH. [Figure 201A] Figures 201A and 201B are isometric views of exemplary embodiments of the measuring valve assembly of the injection pump assembly. [Figure 201B] Figures 201A and 201B are isometric views of exemplary embodiments of the measuring valve assembly of the injection pump assembly. [Figure 202A] Figures 202A-202B show examples of the base trajectory and the delivery schedule for that trajectory. [Figure 202B] Figures 202A-202B show examples of the base trajectory and the delivery schedule for that trajectory. [Figure 203A] Figures 203A-203B show examples of base and extended bolus orbitals and delivery schedules for those orbitals. [Figure 203B] Figures 203A-203B show examples of base and extended bolus orbitals and delivery schedules for those orbitals. [Figure 204A] Figures 204A-204B show examples of base, extended bolus, and normal bolus orbitals, as well as delivery schedules for those orbitals. [Figure 204B] Figures 204A-204B show examples of base, extended bolus, and normal bolus orbitals, as well as delivery schedules for those orbitals.

[0033] Similar reference symbols in various drawings indicate similar elements. [Modes for carrying out the invention]

[0034] Referring to Figures 1-3, the injection pump assembly 100 may include a reusable housing assembly 102. The reusable housing assembly 102 may be constructed from any suitable material, such as rigid or stiff plastic that resists compression. For example, the use of durable materials and components improves quality and reduces costs by providing a longer-lasting, more durable reusable part and providing better protection for the components placed therein.

[0035] The reusable housing assembly 102 may include a mechanical control assembly 104 having a pump assembly 106 and at least one valve assembly 108. The reusable housing assembly 102 may also include an electrical control assembly 110 configured to provide one or more control signals to the mechanical control assembly 104 to achieve basic and / or bolus delivery of the injectable fluid to the user. The disposable housing assembly 114 may include a valve assembly 108 which can be configured to control the flow of the injectable fluid through the fluid path. The reusable housing assembly 102 may also include a pump assembly 106 which can be configured to deliver the injectable fluid from the fluid path to the user.

[0036] The electrical control assembly 110 can monitor and control the amount of injectable fluid that has been and / or is being dispensed. For example, the electrical control assembly 110 may receive a signal from the volume sensor assembly 148, calculate the amount of injectable fluid dispensed, and determine whether sufficient injectable fluid has been dispensed based on the dosage required by the user. If sufficient injectable fluid has not been dispensed, the electrical control assembly 110 may determine that more sufficient injectable fluid should be dispensed. The electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that additional required doses can be dispensed, or so that additional doses can be dispensed with the next dose. Alternatively, if an excess amount of injectable fluid has been dispensed, the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that less injectable fluid can be dispensed with the next dose.

[0037] The mechanical control assembly 104 may include at least one shape memory actuator 112. The pump assembly 106 and / or the valve assembly 108 of the mechanical control assembly 104 may be actuated by at least one shape memory actuator, which may be a shape memory wire in the form of a wire or spring. The shape memory actuator 112 may be operably connected to and activated by an electrical control assembly 110 which can control the timing and amount of thermal and / or electrical energy used to actuate the mechanical control assembly 104. The shape memory actuator 112 may be, for example, a conductive shape memory alloy that changes shape by temperature or equivalent. The temperature of the shape memory actuator 112 may be changed by a heater or, more conveniently, by the application of electrical energy. The shape memory actuator 112 is NITINOL TM Alternatively, it may be a shape memory wire constructed from a nickel / titanium alloy, such as FLEXINOL®.

[0038] The injection pump assembly 100 may include a capacity sensor assembly 148 configured to monitor the amount of fluid injected by the injection pump assembly 100. For example, the capacity sensor assembly 148 may employ, for example, acoustic capacity sensing. Acoustic capacity measurement techniques are the subject of U.S. Patent Nos. 5,575,310 and 5,755,683, assigned to DEKA Products Limited Partnership, and U.S. Patent Application Publications US2007 / 0228071A1, US2007 / 0219496A1, US2007 / 0219480A1, and US2007 / 0219597A1, which are incorporated herein by reference in their entirety. Other alternative techniques for measuring fluid flow rate may also be used, such as Doppler-based methods, the use of Hall effect sensors combined with vane or flapper valves, the use of strain beams (e.g., related to a flexible member on a fluid reservoir to sense the deflection of a flexible member), the use of capacitive sensing with plates, or thermal time-of-flight methods. One such alternative technique is disclosed in U.S. Patent Application No. 11 / 704,899, filed February 9, 2007, titled Fluid Delivery Systems and Methods, which is incorporated herein by reference in its entirety. The injection pump assembly 100 may be configured such that the capacity measurement produced by the capacity sensor assembly 148 can be used to measure the amount of injectable fluid to be injected to the user via a feedback loop.

[0039] The injection pump assembly 100 may further include a disposable housing assembly 114. For example, the disposable housing assembly 114 may be configured for single use or for use for a specified period, such as three days or any other amount of time. The disposable housing assembly 114 may be configured such that any component of the injection pump assembly 100 that comes into contact with the injectable fluid is located on or inside the disposable housing assembly 114. For example, a fluid path or channel including a reservoir may be located within the disposable housing assembly 114 and may be configured for single use or for a specified number of uses before disposal. The disposable nature of the disposable housing assembly 114 may improve the hygiene of the injection pump assembly 100.

[0040] See also Figure 4, the disposable housing assembly 114 may be configured to releasably engage with the reusable housing assembly 102 and include a cavity 116 having a reservoir 118 for receiving an injectable fluid (not shown), such as insulin. Such a releasable engagement may be achieved, for example, by a screw, twist-lock, or compression-fit configuration. The disposable housing assembly 114 and / or the reusable housing assembly 102 may include an alignment assembly configured to assist in aligning the disposable housing assembly 114 and the reusable housing assembly 102 for engagement in a particular orientation. Similarly, the base node 120 and the uppermost node 122 may be used as indicators of alignment and full engagement.

[0041] The cavity 116 may be formed at least partially by and essential to the disposable housing assembly 114. The cavity 116 may include a membrane assembly 124 for at least partially defining a reservoir 118. The reservoir 118 may be further defined by the disposable housing assembly 114, for example, by a recess 126 formed in the base portion 128 of the disposable housing assembly 114. For example, the membrane assembly 124 may be placed on the recess 126 and attached to the base portion 128, thereby forming the reservoir 118. The membrane assembly 124 may be attached to the base portion 128 by conventional means such as adhesive, heat fusion, and / or compression fitting, such that a seal 130 is formed between the membrane assembly 124 and the base portion 128. The membrane assembly 124 may be flexible, and the space formed between the membrane assembly 124 and the recess 126 in the base portion 128 may define the reservoir 118. The reservoir 118 is unpressurized and may be in fluid communication with a fluid path (not shown). The membrane assembly 124 may be at least partially foldable, and the cavity 116 may include a ventilation assembly that can advantageously prevent the accumulation of vacuum in the reservoir 118 when the injectable fluid is delivered from the reservoir 118 to the fluid path. In a preferred embodiment, the membrane assembly 124 is fully foldable and therefore allows for complete delivery of the injectable fluid. The cavity 116 may be configured to provide sufficient space to ensure that there is always some void, even when the reservoir 118 is filled with the injectable fluid.

[0042] The membranes and reservoirs described herein may be made from silicone, nitrile, and any other material having the desired elasticity and properties for functioning as described herein, but may not be limited to these materials. In addition, other structures can serve the same purpose.

[0043] The use of a partially foldable, unpressurized reservoir may advantageously prevent the accumulation of air within the reservoir when the fluid in the reservoir is depleted. The accumulation of air within a ventilated reservoir can prevent fluid leakage from the reservoir, particularly when the system is tilted, so that an air pocket is interposed between the fluid contained in the reservoir and the reservoir's partition. System tilting is expected during normal operation as a wearable device.

[0044] The reservoir 118 may be appropriately sized to hold a sufficient supply of insulin for delivery over a period of one day or more. For example, the reservoir 118 may hold about 1.00 to 3.00 ml of insulin. A 3.00 ml insulin reservoir could roughly correspond to a three-day supply for about 90% of potential users. In other embodiments, the reservoir 118 may be of any size or shape and may be adapted to hold any amount of insulin or other injectable fluid. In some embodiments, the size and shape of the cavity 116 and the reservoir 118 relate to the type of injectable fluid that the cavity 116 and the reservoir 118 are adapted to hold.

[0045] The disposable housing assembly 114 may include a support member 132 (Figure 3) configured to prevent accidental compression of the reservoir 118. Compression of the reservoir 118 can result in an unintended dosage of the injectable fluid being pushed to the user through the path fluid. In preferred embodiments, the reusable housing assembly 102 and the disposable housing assembly 114 may be constructed of a rigid material that is not easily compressible. However, as an additional precaution, the support member 132 may be included within the disposable housing assembly 114 to prevent compression of the injection pump assembly 100 and the cavity 116 within it. The support member 132 may be a rigid projection from the base portion 128. For example, the support member 132 may be located within the cavity 116 to prevent compression of the reservoir 118.

[0046] As discussed above, the cavity 116 may be configured to provide sufficient space to ensure that there is always some void, even when the reservoir 118 is filled with the injectable fluid. Thus, if the injection pump assembly 100 is accidentally compressed, the injectable fluid cannot be pushed through the cannula assembly 136 (for example, shown in Figure 9).

[0047] The cavity 116 may include a partition assembly 146 (Figure 3) configured to allow the reservoir 118 to be filled with an injectable fluid. The partition assembly 146 may be a conventional partition made of rubber or plastic and may have a one-way fluid valve configured to allow a user to fill the reservoir 118 from a syringe or other filling device. In some embodiments, the partition 146 may be located on top of a membrane assembly 124. In these embodiments, the cavity 116 may include a support structure (e.g., a support member 132 in Figure 3) for supporting the area around the back surface of the partition in order to maintain the integrity of the partition seal when a needle is introducing an injectable fluid into the cavity 116. The support structure may be configured to support the partition while still allowing the introduction of a needle for introducing an injectable fluid into the cavity 116.

[0048] The injection pump assembly 100 may, for example, protrude into the cavity 116 and may include an overfill prevention assembly (not shown) which may, for example, prevent overfilling of the storage section 118.

[0049] In some embodiments, the reservoir 118 may be configured to be filled in multiple stages. For example, the reservoir 118 may be refillable through the partition assembly 146. When the injectable fluid is dispensed to the user, the electronic control assembly 110 may monitor the level of the injectable fluid in the reservoir 118. When the fluid level reaches a low point, the electronic control assembly 110 may provide the user with a signal, such as light or vibration, indicating that the reservoir 118 needs to be refilled. A syringe or other filling device may be used to fill the reservoir 118 through the partition 146.

[0050] The storage section 118 may be configured to be filled in a single step. For example, to prevent refilling of the storage section 118, a refill prevention assembly (not shown) may be used so that the disposable housing assembly 114 may be used only once. The refill prevention assembly (not shown) may be a mechanical or electromechanical device. For example, inserting a syringe into a partition assembly 146 to fill the storage section 118 may induce a shutter to cover and close the partition 146 after one filling, thus preventing future access to the partition 146. Similarly, a sensor may induce a shutter to cover and close the partition 146 after one filling by indicating to an electronically controlled assembly 110 that the storage section 118 has been filled once, thus preventing future access to the partition 146. Other means of preventing refilling may be used and shall be deemed to be within the scope of this disclosure.

[0051] As discussed above, the disposable housing assembly 114 may include a partition assembly 146 which may be configured to allow the reservoir 118 to be filled with an injectable fluid. The partition assembly 146 may be a conventional partition made of rubber or any other material capable of functioning as a partition, or in other embodiments, the partition assembly 146 may be, but is not limited to, a one-way fluid valve made of plastic or other material. In various embodiments, including the illustrative embodiment, the partition assembly 146 is configured to allow a user to fill the reservoir 118 from a syringe or other filling device. The disposable housing assembly 114 may include a partition access assembly which may be configured to limit the number of times a user may refill the reservoir 118.

[0052] For example, as also seen in Figures 5A-5C, the partition access assembly 152 may include a shutter assembly 154 which can be held in an "open" position by a tab assembly 156 configured to fit into a slot assembly 158. When the partition 146 is penetrated by the filling syringe 160, the shutter assembly 154 is displaced downward, which can disengage the tab assembly 156 from the slot assembly 158. Once disengaged, the spring assembly 162 can displace the shutter assembly 154 in the direction of arrow 164, and the partition 146 is no longer accessible to the user.

[0053] See also Figure 6A, an alternative embodiment of the bulkhead access assembly 166 is shown in the “open” position. Similar to the bulkhead access assembly 152, the bulkhead access assembly 166 includes a shutter assembly 168 and a spring assembly 170. See also Figure 6B, an alternative embodiment of the bulkhead access assembly 172 is shown in the “open” position, where the tab 178 can engage with the slot 180. Similar to the bulkhead access assembly 166, the bulkhead access assembly 172 may include a shutter assembly 174 and a spring assembly 176. Once the shutter assembly 172 is moved to the “closed” position (for example, to prevent further access to the bulkhead 146 by the user), the tab 178 can engage with the slot 180a at least partially. The engagement between the tab 178 and the slot 180a can lock the shutter assembly 172 in the “closed” position, preventing unauthorized modification or re-opening of the shutter assembly 172. The spring tab 182 of the shutter assembly 172 may bias the tab 178 to engage with the slot 180a.

[0054] However, in various embodiments, the partition access assembly does not have to be actuated linearly. For example, referring also to Figures 7A-7B, an alternative embodiment of the partition access assembly 184 is shown, which includes a shutter assembly 186 configured to pivot around an axis 188. When positioned in the open position (as shown in Figure 7A), the partition 146 may be accessible by a passage 190 (in the shutter assembly 186) that is aligned with, for example, a passage 192 in the surface of the disposable housing assembly 114. However, as with the partition access assemblies 166, 172, when the partition 146 is penetrated by a filling syringe 160 (see Figure 6B), the shutter assembly 186 may be displaced clockwise, and the passage 190 (in the shutter assembly 186) will no longer be aligned with, for example, a passage 192 in the surface of the disposable housing assembly 114, thus preventing access to the partition 146.

[0055] See also Figures 8A-8B, which show a partition access assembly 194 of an alternative embodiment. Similar to partition access assemblies 166 and 172, partition access assembly 194 includes a shutter assembly 196 and a spring assembly 198 configured to bias the shutter assembly 196 in the direction of arrow 200. A filling assembly 202 may be used to fill the reservoir 118. The filling assembly 202 may include a shutter displacement assembly 204 which can be configured to displace the shutter assembly 196 in the direction of arrow 206, which then aligns the passage 208 in the shutter assembly 196 with the partition 146 and the passage 210 in the partition access assembly 194, thus allowing the filling syringe assembly 212 to penetrate the partition 146 and fill the reservoir 118.

[0056] The injection pump assembly 100 may include a sealing assembly 150 (Figure 3) configured to provide a seal between a reusable housing assembly 102 and a disposable housing assembly 114. For example, when the reusable housing assembly 102 and the disposable housing assembly 114 are engaged, for example, by a rotary screw engagement, a twist-lock engagement, or a compression engagement, the reusable housing assembly 102 and the disposable housing assembly 114 may fit together tightly and thus form a seal. In some embodiments, a more secure seal may be desirable. Therefore, the sealing assembly 150 may include an O-ring assembly (not shown). Alternatively, the sealing assembly 150 may include an externally coated seal assembly (not shown). The use of an O-ring assembly or an externally coated seal assembly can make the seal more secure by providing a compressible rubber or plastic layer between the reusable housing assembly 102 and the disposable housing assembly 114 when engaged, thereby preventing penetration by external fluids. In some cases, the O-ring assembly can prevent accidental engagement and disengagement. For example, the sealed assembly 150 may be a watertight assembly, thus allowing the user to wear the injection pump assembly 100 while swimming, bathing, or exercising.

[0057] See also Figure 9, the injection pump assembly 100 may include an external injection set 134 configured to deliver an injectable fluid to the user. The external injection set 134 may be in fluid communication with the cavity 118, for example, through a fluid path. The external injection set 134 may be located adjacent to the injection pump assembly 100. Alternatively, the external injection set 134 may be configured for remote application from the injection pump assembly 100, as will be discussed in more detail below. The external injection set 134 may include a cannula assembly 136 which may include a needle or disposable cannula 138 and a tubing assembly 140. The tubing assembly 140 may be in fluid communication with the reservoir 118, for example, through a fluid path, and with the cannula assembly 138, for example, directly or via a cannula interface 142.

[0058] The external infusion set 134 may be a tethered infusion set, as discussed above with respect to remote application from the infusion pump assembly 100. For example, the external infusion set 134 may be in fluid communication with the infusion pump assembly 100 through a tubing assembly 140 which may be of any length desired by the user (e.g., 3 to 18 inches). The infusion pump assembly 100 may be attached to the user's skin using an adhesive patch 144, but the length of the tubing assembly 140 may alternatively allow the user to wear the infusion pump assembly 100 in a pocket. This may be beneficial for users whose skin is sensitive to the application of the adhesive patch 144. Similarly, wearing and / or securing the infusion pump assembly 100 in a pocket may be preferred for users engaged in physical activity.

[0059] In addition to / as an alternative to the adhesive patch 144, a hook-and-loop system (e.g., a hook-and-loop system provided by Velcro® USA Inc. (Manchester, NH)) may be used to allow easy removal of the injection pump assembly (e.g., injection pump assembly 100) from the user. Therefore, the adhesive patch 144 may be attached to the user's skin and may include outward-facing hook or loop surfaces. In addition, the underside of the disposable housing assembly 114 may include complementary hook or loop surfaces. Depending on the separation resistance of the particular type of hook-and-loop system employed, the strength of the hook and loop connection may be stronger than the strength of the adhesive to the skin connection. Therefore, various hook and loop surface patterns may be used to adjust the strength of the hook and loop connection.

[0060] See also Figures 10A–10E, which illustrate five examples of such hook and loop surface patterns. For illustrative purposes, assume that the entire underside of a disposable housing assembly 114 is covered with the “loop” material. Thus, the strength of the hook and loop connection may be controlled by varying the pattern (i.e., amount) of the “hook” material present on the surface of the adhesive patch 144. Examples of such patterns may include, but are not limited to, a single outer circle 220 of the “hook” material (as shown in Figure 10A), multiple concentric circles 222, 224 of the “hook” material (as shown in Figure 10B), multiple radial spokes 226 of the “hook” material (as shown in Figure 10C), multiple radial spokes 228 combined with a single outer circle 230 of the “hook” material (as shown in Figure 10D), and multiple radial spokes 232 combined with multiple concentric circles 234, 236 of the “hook” material (as shown in Figure 10E).

[0061] In addition, referring to Figure 11A, in one illustrative embodiment of the injection pump assembly described above, the injection pump assembly 100' may be configured via a remote control assembly 300. In this particular embodiment, the injection pump assembly 100' may include a telemetry circuit (not shown) that enables communication (e.g., wired or wireless) between the injection pump assembly 100' and, for example, the remote control assembly 300. Thus, the remote control assembly 300 can remotely control the injection pump assembly 100'. The remote control assembly 300 (which may also include a telemetry circuit (not shown) and may be capable of communicating with the injection pump assembly 100') may include a display assembly 302 and an input assembly 304. The input assembly 304 may include a slider assembly 306 and switch assemblies 308, 310. In other embodiments, the input assembly may include a jog wheel, a plurality of switch assemblies, etc.

[0062] The remote control assembly 300 may include the ability to pre-program base rates, bolus alarms, and delivery limits, and may allow the user to view history and establish user preferences.

[0063] The remote control assembly 300 may also include a glucose flake reader.

[0064] During use, the remote control assembly 300 may provide commands to the injection pump assembly 100' via a wireless communication channel 312 established between the remote control assembly 300 and the injection pump assembly 100'. Therefore, the user may use the remote control assembly 300 to program / configure the injection pump assembly 100'. Some or all of the communication between the remote control assembly 300 and the injection pump assembly 100' may be encrypted to provide an enhanced level of security.

[0065] Communication between the remote control assembly 300 and the injection pump assembly 100' may be achieved using a standard communication protocol. Furthermore, communication between the various components contained within the injection pump assemblies 100, 100' may be achieved using the same protocol. An example of such a communication protocol is the Packet Communication Gateway Protocol (PCGP) developed by DEKA Research & Development (Manchester, NH). As discussed above, the injection pump assemblies 100, 100' may include an electrical control assembly 110 which may include one or more electrical components. For example, the electrical control assembly 110 may include multiple data processors (e.g., a supervisor processor and a command processor) and a wireless processor to enable the injection pump assemblies 100, 100' to communicate with the remote control assembly 300. Furthermore, the remote control assembly 300 may include one or more electrical components, including, but not limited to, a command processor and a wireless processor to enable the remote control assembly 300 to communicate with the injection pumps 100, 100'. A high-level diagram of an example of such a system is shown in Figure 11B.

[0066] Each of these electrical components may be manufactured by a different component supplier and therefore may utilize its own (i.e., unique) communication commands. Thus, efficient communication between such heterogeneous components may be achieved through the use of standard communication protocols. PCGP can be a flexible and extensible software module that can be used in the processors within the injection pump assemblies 100, 100' and the remote control assembly 300 to construct and send packets. PCGP may abstract various interfaces and provide a unified application programming interface (API) to various applications running in each processor. PCGP may also provide adaptive interfaces to various drivers. For illustrative purposes only, PCGP may have the conceptual structure shown in Figure 11C for a given processor.

[0067] PCGP can ensure data integrity by utilizing periodic redundancy checks (CRC). PCGP may also provide guaranteed delivery conditions. For example, every new message should have a reply. If such a reply is not sent back in time, the message may time out, and PCGP may generate a negative response reply message (i.e., NACK) to the application. Thus, the message reply protocol may inform the application whether it should retry sending the message.

[0068] PCGP may also limit the number of in-flight messages from a given node, may be coupled with a traffic control mechanism at the driver level to provide a deterministic approach to message delivery, and may provide individual nodes with different amounts of buffer without withdrawing packets. When a node runs out of buffer, the driver may provide back pressure to other nodes to prevent the transmission of new messages.

[0069] PCGP may use a shared buffer pool strategy to minimize data copying and may avoid mutual exclusion, which may have a slight impact on the API used to send / receive messages to / from applications and a more significant impact on drivers. PCGP may use a “bridge” base class that provides routing and buffer ownership. Major PCGP classes may be subdivided from the bridge base class. Drivers may be derived from bridge classes, communicate with derived bridge classes, or own them.

[0070] PCGP can be designed to operate in embedded environments, with or without an operating system, by using semaphores to protect shared data, allowing some calls to be reentrant and enabling operation across multiple threads. Figure 11D shows one illustrative example of such an implementation. PCGP may operate in the same manner in both environments, but there may be versions of the calls for a specific processor type (e.g., ARM 9 / OS version). Thus, the functionality may be the same, but there may be an operating system abstraction layer with slightly different calls, for example, suited to the ARM 9 Nucleus OS environment.

[0071] Referring also to Figure 11E, PCGP may do the following: • Enables multiple send / reply calls (on Pilot's ARM 9 on multiple reentrant tasks). • It has multiple drivers that operate asynchronously for RX and TX on different interfaces. • Provides packet ordering for sending / receiving, and a deterministic timeout for message transmission.

[0072] Each software object may request the buffer manager for the next buffer it will use, and then give that buffer to another object. Buffers may pass automatically from one exclusive owner to another, and queues may arise automatically by ordering buffers by sequence number. When a buffer is no longer in use, it may be recycled (for example, an object may offer the buffer to itself or release it to the buffer manager for later reallocation). Thus, data generally does not need to be copied, and routing simply overwrites the buffer owner bytes.

[0073] Such an implementation of PCGP may offer various benefits, including, but not limited to, the following: Once a message is placed in a buffer, it may persist there until it is forwarded or received by an application, and therefore it may not be possible to withdraw the message due to the buffer running out. • Offsets are used to access the driver, PCGP, and buffer payload sections, so data does not need to be copied. The driver may change ownership of the message data by overwriting one byte (i.e., the buffer ownership byte). Mutual exclusion may only be necessary when a single buffer owner may wish to use the buffer concurrently or acquire a new sequence number; therefore, the need for multiple exclusions, except for reentrant calls, may not be necessary. • Application writers may need to follow fewer rules to implement a reliable system. Since there is a set of calls provided by the driver to push / retrieve data outside of the buffer management system, the driver may use an ISR / push / retrieve / and polled data model. ·The driver may not need to perform copy, CRC, or any checks, but since destination bytes and CRC as well as other checks may be performed later from the ISR hot path, the driver may not need to operate much beyond TX and RX. ·Since the buffer manager may order accesses by sequence number, queue ordering may occur automatically. ·Small code / variable footprint may be utilized, the hot path code may be small, and the overhead may be low.

[0074] As shown in Figure 11F, when a message needs to be sent, PCGP may quickly build a packet and insert it into the buffer management system. Once inside the buffer management system, a call to "packetProcessor" may apply protocol rules and provide the message to the driver / application.

[0075] To send a new message or send a reply, PCGP may do the following. ·Check the call arguments, for example, to confirm that the packet length is legal, the destination is correct, etc. ·Allow the downlink to be used by the PCGP with the radio processor to establish links, pairs, etc., and notify the application when the PCGP is trying to communicate on a link that is not functioning (instead of timing out). Avoid trying to send a message on a downed link unless it is a wireless link. ·Obtain the sequence number of a new message or utilize the existing sequence number of an existing message. ·Build the packet, copy the payload, write to the CRC, and the integrity of the packet may be protected by the CRC since this point. - Provide the message to the buffer manager as a reply or new message, and check if putting this buffer into the buffer manager exceeds the maximum number of outgoing messages in the waiting state.

[0076] See also Figures 11G-11H, PCGP may operate by having all the major work done in a single thread to avoid mutual exclusion and to avoid doing a lot of work in send / reply or driver calls. The "packetProcessor" call may need to apply protocol rules to reply, new send, and receive messages. Reply messages may simply be sent, while new and received messages may have rules for sending the message. In each case, the software may loop as long as it is possible to apply protocol rules to the correct type of message until it can no longer process packets.

[0077] Sending a new message may follow the rules below. Even just two messages can be considered authorized "in-flight" messages on the network. Sufficient data about the in-flight message may be stored to match the response and handle timeouts.

[0078] Message reception may follow the rules below. • A matching response may remove the "in-flight" information slot, allowing a new packet to be sent. • Inconsistent responses may be withdrawn. • New messages may be related to a protocol (for example, to retrieve / clear network statistics for this node). A buffer may be provided to the application to receive messages, and a callback may be used. The buffer may be released or it may remain owned by the application.

[0079] Therefore, PCGP may be configured as follows: The recall function may copy the payload data out or use it completely before returning. The callback function may own the buffer, refer to the buffer's payload by the buffer and payload address, and the message may be processed later. The application may poll the PCGP system for received messages. The application may use a callback to set an event and then poll for incoming messages.

[0080] The communication system may have a limited number of buffers. When the PCGP runs out of buffers, the driver may stop receiving new packets, and the application may be told that it cannot send new packets. To avoid this and maintain optimal performance, the application may attempt one or more steps, including, but not limited to, the following:

[0081] a) Applications should keep PCGP up-to-date wirelessly. Specifically, if the link goes down and PCGP is unaware, PCGP may receive new messages to send and queue them (or not optimally time out the messages), which can disrupt the send queue and delay applications from optimally using the link.

[0082] b) The application should periodically call "decrement timeout". Optimally, this should be every 20-100 milliseconds, unless the processor is paused. Generally, messages travel fast (a few milliseconds), slow (a few seconds), or not at all. The timeout is an attempt to remove "in-flight" messages that should be withdrawn to free up buffers and bandwidth. Not doing this often may delay when new messages are sent or when the application queues new messages.

[0083] c) The application should ask the PCGP if there is any pending work to do before pausing. If there is nothing for the PCGP to do, the driver activity may start the system, and therefore the PCGP, and then the PCGP, will not need to call "packetProcessor" or "decrement timeout" until a new packet enters the system. Failure to do so may result in the timeout condition causing messages that should have been successfully sent / forwarded / received to be withdrawn.

[0084] d) Applications should not hold onto received messages indefinitely. The messaging system relies on prompt replies. If an application shares a PCGP buffer, holding onto a message means holding onto the PCGP buffer. A receiving node does not know if the sending node has timeouts configured for slow or fast wireless communication. This means that when a node receives a message, it should measure the network's fast timeout rate.

[0085] e) The application should frequently call "packetProcessor". Calls may cause the application to send new messages that have been queued, or to handle the receipt of new messages. Calls may also cause buffer reallocation, and infrequent calls may cause delays in message traffic.

[0086] As shown in Figure 11I, at some point the RX driver may be prompted to receive a message from the other side of the interface. To ensure that the message is not withdrawn, the RX driver may ask the buffer manager if there is a buffer available to store the new message. The driver may then request a buffer pointer and begin filling the buffer with the received data. Once a complete message is received, the RX driver may invoke a function to send the packet. The routing function may examine the destination byte in the packet header and change ownership to another driver or application, or it may detect that the packet is bad and withdraw the packet by freeing the buffer.

[0087] The PCGP RX overhead may consist of requesting the next available buffer and calling the route function. An example of code that performs such functions is shown below.

[0088] [Table 1] The driver may perform TX by asking the buffer manager for a pointer to the next buffer to be transmitted. Next, the TX driver may ask the other side of the interface whether it can receive a packet. If the other side rejects the packet, the TX driver may not need to do anything to the buffer because its state has not changed. Otherwise, the driver may transmit the packet and recycle / free the buffer. An example of code that performs such a function is as follows.

[0089]

Table 2

[0090] As shown in Figures 11J to 11L, during the buffer allocation process, buffers marked as available may be transferred to the driver to receive new packets or to the PCGP to receive a new payload for TX. The allocation from "available" may be performed by the "packetProcessor" function. The number of transmissions and receptions during a "packetProcessor" call may determine how many LT_Driver_RX, GT_Driver_RX, and PCGP_Free buffers need to be allocated. The LT Driver may represent a driver that handles addresses less than the node address. The GT_Driver may represent a driver that handles addresses greater than the node address.

[0091] When the driver receives a packet, it may place the data into the RX buffer, which is then passed to the router. The router may then reallocate the buffer to PCGP_Receive or another driver's TX (not shown). If the buffer contains obviously invalid data, the buffer may transition to an available state.

[0092] After the router marks a buffer for TX, the driver may discover that the buffer is TX and send a message. After sending the message, if the driver is low on RX buffers, the buffer may immediately become an RX buffer, or the buffer may be freed for reallocation. During the "packetProcessor" call, PCGP may process all buffers that the router has marked as PCGP_Receive. At this point, the CRC and other data items may be checked as the data may be affected. If the data is corrupted, the statistics may be incremented and the buffer may be freed. Otherwise, the buffer may be marked as owned by the application. Buffers marked as owned by the application may be recycled for use by PCGP or freed for reallocation by the buffer manager.

[0093] When an application wants to send a new message, it may do so in a reentrant, straightforward / mutual exclusion manner. If a buffer may be allocated, PCGP may mark the buffer as in use. Once marked as in use, it is owned by the invocation of the send or reply function call, and therefore no other thread calling this function should capture this buffer. Error checking and the rest of the message creation process may be performed outside of the isolated race condition mutual exclusion protection code. The buffer may transition to the available state, or become a valid, filled, CRC-checked buffer and be passed to the router. These buffers do not have to be sent immediately and may be queued so that messages can be sent later (assuming protocol rules allow it). Reply messages may be sent with higher priority than regular outgoing messages, and there may be no rules limiting how many / when reply messages can be sent, so reply messages may be marked differently from new outgoing messages.

[0094] PCGP is designed to work in conjunction with flow control, and because there is no buffer on the other side of the interface (which can cause back pressure on the transmitting node), flow control may negotiate about the forwarding of messages from one node to another to ensure that the buffer is never withdrawn.

[0095] Flow control may be part of a shared buffer format. The first two bytes may be reserved for the driver so that the driver never needs to shift packet bytes. The two bytes may be used such that one byte is the DMA length minus 1 and the second byte controls the flow of the message. These same two bytes may synchronize bytes when the PCGP message is transmitted over RS232.

[0096] When a packet is "in flight," it may be in the process of being sent by a driver, processed by a destination, or returned as a response en route to its destination.

[0097] Typical delays are as follows:

[0098] [Table 3] Therefore, messages tend to complete their round trip quickly (e.g., <50ms), slowly (e.g., more than 1 second), or not complete at all.

[0099] PCGP may use two different timeouts (configured during initialization) for all timeouts: one for when the RF link is in fast heartbeat mode and another for when the RF link is in slow mode. If a message is in flight and the link state changes from fast to slow, the timeout may be adjusted, and the difference between fast and slow may be added to the expiration counter for the packet. No additional transitions before or after should affect the expiration of the message.

[0100] There is a second timeout, which may be twice as long as the slow timeout, used to monitor buffer allocation within PCGP. Therefore, if a message is "stuck" within the driver and not sent, for example due to traffic control or hardware failure, the buffer may be released by the buffer manager, causing the buffer to be withdrawn. For "new" messages, this may mean that the application has already received a reply indicating that the packet has already timed out and the message was not delivered. The buffer is released so that the driver can pass a message to the driver that can be sent, once the obstacle is removed, as the driver polls the buffer manager for buffers that need to be sent. For reply messages, the reply may simply be withdrawn, causing the sending node to time out.

[0101] The PCGP messaging system may pass messages containing header information and payload. Outside of PCGP, the header may be a set of data items in a call signature. However, within PCGP, there may be a byte layout that is easy for a consistent driver to use. The driver may insert bytes into or before PCGP packets, as follows: • DE, CA: Synchronization bytes for use with RS232, nominal values ​​0xDE, 0xCA, or 0x5A, 0xA5. • LD: Driver DMA length bytes, the total size excluding size bytes or synchronization bytes, equal to the amount the driver is pushing in this DMA transfer. • Cmd: Driver commands and control bytes used for flow control. • LP: PCGP packet length, always equal to the total header + payload size in bytes + CRC size. LD = LP + 1. Dst: Destination address. • Src: Source address. • Cmd: command byte • Scd: Subcommand byte • AT: Application tag are defined by the application and are not important to PCGP. This allows applications to attach further information to messages, such as the thread from which the message originated. • SeqNum: A 32-bit sequence number is incremented by PCGP for each new message sent, ensuring that the number is not rounded up, acts as a token, and is endianness-independent. • CRC16: 16-bit CRC for PCGP header and payload.

[0102] An example of a message with no payload and with cmd=1 and subcmd=2 is as follows:

[0103] [Table 4] This methodology may have several advantages, which may include, but are not limited to, the following: Most of our hardware DMA engines may use the first byte to specify how many additional bytes to move, and therefore, in this methodology, the driver and PCGP may share a buffer. A byte may be provided immediately after the DMA length to pass flow control information between drivers. Since the driver length and the "Cmd" byte may be outside the CRC area, they may be modified by the driver, owned by the driver transport mechanism, and the driver may be vigilant about invalid lengths. There may be a separate PGCP packet length byte protected by CRC. Therefore, the application may trust that its payload length is correct. The endianness of a sequence number is merely a byte pattern that happens to be a 32-bit integer and may match, so it does not need to be relevant. The sequence number may be four bytes aligned to the edge of the shared buffer pool length. An optional RS232 synchronization byte may be provided to allow the user to move the cable around while debugging the message stream, and for both sides of the interface to resynchronize. Applications, drivers, and PCGP may share buffers and free them by pointers.

[0104] PCGP does not have to be an event-driven software design, but may be used in an event-driven architecture depending on how the subclasses are written. Data may be exchanged conceptually between classes (as shown in Figures 11M-11N).

[0105] Some event models in the driver may involve starting the driver, receiving a message, or passing the message through a bridge to a buffer manager that sends the message to the new owner of the new message (through the driver or a bridge to PCGP).

[0106] The following summarizes some illustrative events.

[0107] [Table 5] The following illustrative example shows how a PCGP event model may work with Nucleus to initiate a PCGP task after a decTimeout has generated all sent messages, replies, or NACKs.

[0108] [Table 6] The following is an event-based pseudocode driver illustrating how driver events work. The driver subdivides the Bridge, disables hasMessagesToSend and flowControlTumedOff, and plans to activate the TX and RX functions if they are not already active.

[0109] [Table 7-1]

[0110] [Table 7-2] The following statistics may be supported by PCGP. • Number of packets sent · Number of packets received CRC error ·timeout • Unavailable buffer (buffer is gone) PCGP may be designed to operate in multiple processing environments. Most parameters may be runtime configured to facilitate testing and runtime fine-tuning of performance. Other parameters may be compile-time parameters, and may be anything that modifies, for example, memory allocations that must be performed statically at compile time.

[0111] The following may specify the number of compile-time configurations, which may vary in where PCGP is implemented. • Driver bytes: These may be 2 bytes reserved for the common buffer scheme for the driver, but this may also be a compilation time option adapted to other drivers such as RF protocols. • RX buffer count: This may be adjusted to suit the processor / traffic flow, etc. • PCGP RX buffer count: The number of buffers may be adjusted to suit the processor / traffic flow, etc. • Total number of buffers: This may be tuned to determine how many buffers should be present in that processor.

[0112] A CRC may be used to ensure data integrity. If the CRC is invalid, it may not be delivered to the application, and CRC errors may be tracked. The message may eventually time out and may be retried by the originator.

[0113] Similarly, if the messaging system informs an application that a message was delivered when it was not, this can be dangerous for the system. A bolus stop command is an example of such a command. This may be mitigated by a message request / action sequence, which may be required by the application to change the treatment method. The controller may receive a matching command from the pump application to review the delivered message.

[0114] DEKA may provide a reference method for interfaceping PCGP to a Nucleus OS system on ARM 9 (as shown in Figure 11O).

[0115] As shown in Figure 11P, the pcgpOS.cpp file may create instances of PCGP node instances (Pcgp, Bridge, etc.) and may provide a set of C-linkable function calls through pcgpOS.h that provide a C language interface to C++ code. This may simplify the implicit nature of the C code as the object being acted upon.

[0116] The following general rules may apply. PCGP may operate on all nodes. Any driver may support a general driver interface. • Race conditions should not be allowed. Half-duplex support may be provided on the SPI port between the slave processor and the master processor. • Data transfer may not be attempted, as it will either succeed or fail / false. • Low overhead (wasted time, processing, bandwidth) may be required. • The CC2510 operating at DMA (high-speed) SPI clock speeds may be supported.

[0117] If the receiving end does not currently have an empty buffer to place the packet in, SPI traffic control may prevent the data from being transmitted. This may be achieved by requesting permission to transmit and waiting for a response indicating that permission has been granted. Alternatively, there may be a way to inform the recipient that there is currently no free buffer and that they should attempt to transmit at a later date.

[0118] All transmissions may begin with a length byte indicating the number of bytes to be sent, which does not include the length byte itself. The length may be followed by a single byte indicating the command being sent.

[0119] The actual transmission of a packet may consist of the command byte, which may be the length of the packet plus one, followed by the command byte for any attached message, and finally the packet itself.

[0120] In addition to the command bytes that are sent, an additional hardware line called a flow control line may be added to the four conventional SPI signals. The purpose of this line is to allow the protocol to operate as quickly as possible without requiring a pre-configured delay. It also allows the slave processor to inform the master processor that there are packets waiting to be sent, thus eliminating the need for the master processor to poll the slave processors for status.

[0121] The following illustrative command values ​​may also be used.

[0122] [Table 8]

[0123] [Table 9] As shown in Figure 11Q, when a slave processor has packets to send to the master processor, the slave processor may notify the master processor (by asserting a flow control line) that there are pending packets waiting to be sent. Doing so may result in an IRQ on the master processor, at which point the master processor may decide when to retrieve the message from the slave processor. Packet retrieval may be delayed at the discretion of the master processor, and the master processor may decide to attempt to send the packet to the slave processor before retrieving it from the slave processor.

[0124] The master processor may initiate retrieval by sending the slave processor an M_CTS command, which shall be repeated until the slave processor responds by sending an S_MSG_APPENDED command along with the packet itself. The flow control line may be released after the packet has been sent. If the M_CTS command is received by the slave processor unexpectedly, the M_CTS command may be ignored.

[0125] As illustrated in Figure 11R, when the master processor has a packet to send to the slave processor, the master processor may initiate the transfer by sending an M_RTS command. Upon receiving the M_RTS command, if the slave processor currently has any pending transmit packets, the slave processor lowers the flow control line so that it may be reused as a transmit enable signal. The slave processor may then inform the master processor that it is in the process of preparing SPI DMA to receive the packet, during which time the master processor may stop measuring byte time on the bus, allowing the slave processor to finish preparing to receive.

[0126] Next, the slave processor may indicate that it is ready to receive the entire packet by raising the flow control line (used as the CTS signal). Upon receiving the CTS signal, the master processor may then send the M_MSG_APPENDED command along with the packet itself.

[0127] After the transfer is complete, the slave processor may lower the flow control line. If the packet was pending at the start of the transfer, or if transmission occurred on the slave processor while the packet was being received, the slave processor may reassert the flow control line indicating that there is a pending packet.

[0128] Referring again to Figure 11A, the infusion pump assemblies 100, 100' may include a switch assembly 318 connected to an electrical control assembly 110 (Figure 3), which may enable a user (not shown) to perform at least one task, and in some embodiments, multiple tasks. One illustrative embodiment of such a task is the administration of a bolus dose of an injectable fluid (e.g., insulin) without using a display assembly. A remote control assembly 300 may enable / deactivate / configure the infusion pump assemblies 100, 100' to administer a bolus dose of insulin.

[0129] See also Figure 12A, the slider assembly 306 may be configured, at least in part, to allow the user to interact with menu-based information rendered on the display assembly 302. An example of the slider assembly 306 may include a capacitive slider assembly, which may be implemented using the CY8C21434-24LFXI PSOC provided by Cypress Semiconductor (San Jose, California), the design of which is described in the "CSD User Module" published by Cypress Semiconductor. For example, via the slider assembly 306, the user may slide their finger in the direction of arrow 314 to bring up highlighted portions of information contained within the main menu 350 (shown in Figure 12A) rendered on the display assembly 302, which scrolls upward. Alternatively, the user may slide their finger in the direction of arrow 316 to bring up highlighted portions of information contained within the main menu 350 rendered on the display assembly 302, which scrolls downward.

[0130] The slider assembly 306 may be configured such that the speed at which the highlighted portion of the main menu 350 scrolls "up" or "down" varies depending on the displacement of the user's finger relative to the starting point 320. Therefore, if the user wishes to scroll "up" rapidly, the user may position their finger near the top of the slider assembly 306. Similarly, if the user wishes to scroll "down" rapidly, the user may position their finger near the bottom of the slider assembly 306. In addition, if the user wishes to scroll "up" slowly, the user may position their finger slightly "up" relative to the starting point 320. Furthermore, if the user wishes to scroll "down" slowly, the user may position their finger slightly "down" relative to the starting point 320. Once the appropriate menu item is highlighted, the user may select the highlighted menu via one or more switch assemblies 308, 310.

[0131] Referring also to Figures 12B-12F, we assume for illustrative purposes that the infusion pump assembly 100, 100' is an insulin pump, and the user wishes to configure the infusion pump assembly 100, 100' such that when the switch assembly 318 is pressed by the user, a 0.20 unit bolus dose of insulin is administered. Therefore, the user may use the slider assembly 306 to highlight "Bolus" in the main menu 350, which is rendered on the display assembly 302. The user may then use the switch assembly 308 to select "Bolus". Once selected, processing logic (not shown) in the remote control assembly 300 may render a submenu 352 on the display assembly 302 (as shown in Figure 12B).

[0132] The user may then use the slider assembly 306 to highlight "Manual Bolus" in submenu 352, which may be selected using switch assembly 308. The processing logic (not shown) in remote control assembly 300 may then render submenu 354 on display assembly 302 (as shown in Figure 12C).

[0133] The user may then use the slider assembly 306 to highlight "Bolus: 0.0 Unit" in the submenu 354, which may be selected using the switch assembly 308. The processing logic (not shown) in the remote control assembly 300 may then render the submenu 356 on the display assembly 302 (as shown in Figure 12D).

[0134] Next, the user may use the slider assembly 306 to adjust the "bolus" insulin amount to "0.20 units," which may be selected using the switch assembly 308. Then, processing logic (not shown) within the remote control assembly 300 may render a submenu 358 on the display assembly 302 (as shown in Figure 12E).

[0135] Next, user 14 may use slider assembly 306 to highlight "Confirm," which may be selected using switch assembly 308. Then, processing logic (not shown) in remote control assembly 300 may generate appropriate signals that may be sent to the telemetry circuit (not shown) included in control assembly 300. Then, the telemetry circuit (not shown) included in control assembly may transmit appropriate configuration commands to configure infusion pump assembly 100' via wireless communication channel 312 established between remote control assembly 300 and infusion pump assembly 100' so that whenever switch assembly 318 is pressed by the user, a 0.02 unit bolus volume of insulin is administered.

[0136] Once the transmission of the appropriate command is successful, the processing logic (not shown) within the remote control assembly 300 may render the submenu 350 again on the display assembly 302 (as shown in Figure 12F).

[0137] Specifically, once programmed via the remote control assembly 300, the user may press the switch assembly 318 of the infusion pump assembly 100' to administer a 0.20-unit bolus dose of the insulin described above. The user may also specify the amount of insulin administered each time the user presses the switch assembly 318 via the menu system contained within the remote control assembly 300. While this particular embodiment identifies one press of the switch assembly 318 as equivalent to 0.20 units of insulin, this is for illustrative purposes only and is not intended to limit the disclosure, as other values ​​(e.g., 1.00 unit of insulin per press) are equally applicable.

[0138] Let us assume, for illustrative purposes, that a user wishes to receive a 2.00 unit bolus dose of insulin. To activate the bolus dose delivery system described above, the user may need to press and hold the switch assembly 318 for a specified period (e.g., 5 seconds), at which point the infusion pump assembly 100, 100' may generate an audible signal indicating to the user that the infusion pump assembly 100, 100' is ready to deliver a bolus dose of insulin via the switch assembly 318. Thus, the user may press the switch assembly 318 10 times (i.e., 2.00 units is 10 doses of 0.20 units). After each press of the switch assembly 318, the infusion pump assembly 100, 100' may provide the user with an audible response via an internal speaker / sound generating device (not shown). Therefore, the user may first press the switch assembly 318, and the infusion pump assemblies 100, 100' may generate a confirmation beep accordingly, thus indicating to the user that the infusion pump assemblies 100, 100' have received a command for 0.20 units of insulin (in this particular embodiment). Since the desired bolus dose is 2.00 units of insulin, the user may repeat this procedure nine more times to achieve a bolus dose of 2.00 units, with the infusion pump assemblies 100, 100' generating a confirmation beep after each press of the switch assembly 318.

[0139] In this particular embodiment, the infusion pump assemblies 100, 100' are described as providing one beep each time the user presses the switch assembly 318, but this is for illustrative purposes only and is not intended to limit the present disclosure. Specifically, the infusion pump assemblies 100, 100' may be configured to provide a single beep for each specified amount of insulin. As discussed above, one press of the switch assembly 318 may be equivalent to 0.20 units of insulin. Thus, the infusion pump assemblies 100, 100' may be configured to provide a single beep for each 0.10 units of insulin. Therefore, if the infusion pump assemblies 100, 100' are configured such that one press of the switch assembly 318 is equivalent to 0.20 units of insulin, then each time the switch assembly 318 is pressed, the infusion pump assemblies 100, 100' may provide the user with two beeps (i.e., one for each 0.10 units of insulin).

[0140] Once the user has pressed the switch assembly 318 on the infusion pump assembly 100' a total of 10 times, the user may simply wait for the infusion pump assembly 100' to acknowledge receipt of the command to administer a 2.00 unit bolus dose of insulin (in contrast to the confirmation beeps received with each press of the switch assembly 318). Once a specified period (e.g., 2 seconds) has elapsed, the infusion pump assembly 100' may provide the user with an audible confirmation regarding the unit amount to be administered via the bolus insulin dose requested by the user. For example, if the infusion pump assembly 100' is programmed by the user so that (in this embodiment) one press of the switch assembly 318 is equivalent to 0.20 units of insulin, the infusion pump assembly 100' may emit 10 beeps (i.e., 2.00 units is 10 doses of 0.20 units).

[0141] When providing feedback to the user regarding the volume of units administered via a bolus insulin dose, the infusion pump assembly 100, 100' may provide multi-frequency audible confirmation. For example, continuing the above embodiment in which 10 beeps are provided to the user, the infusion pump assembly 100, 100' may group the beeps into groups of five (to facilitate easier counting by the user), and the beeps within each group of five may be rendered by the infusion pump assembly 100, 100' such that each subsequent beep has a higher frequency than the preceding beep (similar to a musical scale). Therefore, continuing with the above embodiment, the injection pump assemblies 100, 100' may render a 1,000 Hz beep, followed by a 1,100 Hz beep, followed by a 1,200 Hz beep, followed by a 1,300 Hz beep, followed by a 1,400 Hz beep (thus completing a group of five beeps), followed by a short pause, then a 1,000 Hz beep, followed by a 1,100 Hz beep, followed by a 1,200 Hz beep, followed by a 1,300 Hz beep, followed by a 1,400 Hz beep (thus completing a second group of five beeps). According to various additional / alternative embodiments, multi-frequency audible confirmation may utilize a variety of timbres with incrementing frequencies. For example, an embodiment may utilize 20 different timbres with incrementing frequencies. However, the number of timbres may vary depending on the design criteria and user needs, so the number of timbres should not be interpreted as a limitation of this disclosure.

[0142] Once the infusion pump assemblies 100, 100' have completed rendering the multi-frequency audible confirmation (i.e., the 10 beeps described above), the user may press the switch assembly 318 within a specified period (e.g., 2 seconds) to provide a confirmation signal to the infusion pump assemblies 100, 100', indicating that the multi-frequency audible confirmation is accurate and indicates the size of the bolus dose of insulin to be administered (i.e., 2.00 units). Upon receiving this confirmation signal, the infusion pump assemblies 100, 100' may render an audible "confirmation received" sound and (in this particular embodiment) achieve delivery of a 2.00 unit bolus dose of insulin. If the infusion pump assemblies 100, 100' have not received the above confirmation signal, the infusion pump assemblies 100, 100' may render an audible "confirmation failed" sound and fail to achieve delivery of the bolus dose of insulin. Therefore, if multi-frequency audible confirmation is inaccurate / does not indicate the size of the bolus dose of insulin to be administered, the user may simply refrain from providing the confirmation signal described above, thereby discontinuing the delivery of the bolus dose of insulin.

[0143] As discussed above, in one illustrative embodiment of the injection pump assembly described above, the injection pump assembly 100' may be used to communicate with a remote control assembly 300. When such a remote control assembly 300 is used, the injection pump assembly 100' and the remote control assembly 300 may periodically contact each other to ensure that the two devices are still communicating with each other. For example, the injection pump assembly 100' may "ping" the remote control assembly 300 to ensure that the remote control assembly 300 is present and operational. Furthermore, the remote control assembly 300 may "ping" the injection pump assembly 100' to ensure that the injection pump assembly 100' is still present and operational. If one of the injection pump assembly 100' and the remote control assembly 300 fails to establish communication with the other assembly, the assembly that fails to establish communication may sound a "separation" alarm. For example, suppose the injection pump assembly 100' is in the user's pocket while the remote control assembly 300 is left in the user's car. Therefore, after a specified period, the injection pump assembly 100' may begin sounding a “separation” alarm, indicating that it cannot establish communication with the remote control assembly 300. The user may use the switch assembly 318 to acknowledge / silence this “separation” alarm.

[0144] Since a user may define and administer a bolus insulin dose via the switch assembly 318 of the infusion pump assembly 100' while the remote control assembly 300 is not communicating with the infusion pump assembly 100', the infusion pump assembly 100' may store information about the administered bolus insulin dose in a log file (not shown) stored within the infusion pump assembly 100'. This log file (not shown) may be stored in non-volatile memory (not shown) contained within the infusion pump assembly 100'. When communication is re-established between the infusion pump assembly 100' and the remote control assembly 300, the infusion pump assembly 100' may provide the remote control assembly 300 with information about the administered bolus insulin dose stored in the log file (not shown) of the infusion pump assembly 100'.

[0145] Furthermore, if the user anticipates separating the remote control assembly 300 from the injection pump assembly 100', the user may configure the injection pump assembly 100' and the remote control assembly 300 to enter "separated" mode (via the menu system described above), thereby eliminating the occurrence of the "separated" alarm described above. However, the devices may continue to "ping" each other so that the injection pump assembly 100' and the remote control assembly 300 may automatically exit "separated" mode once they resume communication with each other.

[0146] Furthermore, if the user anticipates traveling by aircraft, the user may configure the injection pump assembly 100' and the remote control assembly 300 (via the menu system of the remote control assembly 300) to enter "aircraft" mode, which suspends all data transmissions. While in "aircraft" mode, the injection pump assembly 100' and the remote control assembly 300 may or may not continue to receive data.

[0147] The switch assembly 318 may be used to perform additional functions such as checking the battery life of the reusable housing assembly 102, matching the reusable housing assembly 102 with the remote control assembly 300, and interrupting the administration of a bolus dose of the injectable fluid.

[0148] Steps for checking battery life: The reusable housing assembly 102 may include a rechargeable battery assembly that can power the injection pump assembly 100, 100' for approximately 3 days (when fully charged). Such a rechargeable battery assembly may have a predetermined number of usable hours, e.g., a usable life of several years, or other predetermined length of usable hours. However, the predetermined life may depend on many factors, including but not limited to one or more of climate, daily use, and the number of recharges. Whenever the reusable housing assembly 102 is disconnected from the disposable housing assembly 114, the injection pump assembly 100, 100' may perform a battery check on the above rechargeable battery assembly whenever the switch assembly 318 has been pressed for a specified period (e.g., more than 2 seconds). If it is determined that the above rechargeable battery assembly is charged above a desired threshold, the injection pump assembly 100, 100' may render a "battery passed" sound. Alternatively, if it is determined that the above rechargeable battery assembly is charged below a desired threshold, the injection pump assembly 100, 100' may render a “low battery” tone. The injection pump assembly 100, 100' may include components and / or circuits that determine whether the reusable housing assembly 102 is disconnected from the disposable housing assembly 114.

[0149] Matching Step: As discussed above, in one illustrative embodiment of the injection pump assembly described above, the injection pump assembly 100' may be used to communicate with the remote control assembly 300. A matching process may be performed to achieve communication between the injection pump assembly 100' and the remote control assembly 300. During such a matching process, one or more injection pump assemblies (e.g., injection pump assembly 100') may be configured to communicate with the remote control assembly 300, and (conversely) the remote control assembly 300 may be configured to communicate with one or more injection pump assemblies (e.g., injection pump assembly 100'). Specifically, the serial number of an injection pump assembly (e.g., injection pump assembly 100') may be recorded in a matching file (not shown) contained within the remote control assembly 300, and the serial number of the remote control assembly 300 may be recorded in a matching file (not shown) contained within an injection pump assembly (e.g., injection pump assembly 100').

[0150] According to the embodiment, in order to achieve such a matching procedure, the user may simultaneously press one or more switches on both the remote control assembly 300 and the injection pump assembly 100'. For example, the user may simultaneously press the switch assembly 310 contained within the remote control assembly 300 and the switch assembly 318 contained within the injection pump assembly 100' for a specified period of time, for example, more than 5 seconds. Once this specified period is reached, one or more of the remote control assembly 300 and the injection pump assembly 100' may generate an audible signal indicating that the matching procedure described above has been achieved.

[0151] In another embodiment, the user may separate the reusable housing assembly 102 from the disposable housing assembly 114 before performing the pairing process. Requiring this initial step provides further assurance that the injection pump assembly installed by the user cannot be intimately paired with the remote control assembly.

[0152] Once disconnected, the user may enter pairing mode via the input assembly 304 of the remote control assembly 300. For example, the user may enter pairing mode on the remote control assembly 300 via the menu system described above, for example, in combination with the switch assembly 310. The user may be prompted on the display assembly 302 of the remote control assembly 300 to press and hold the switch assembly 318 on the injection pump assembly 100'. In addition, the remote control assembly 304 may switch to a low-power mode to avoid attempting to pair with, for example, the remote injection pump assembly. Next, the user may press and hold the switch assembly 318 on the injection pump assembly 100' to put the injection pump assembly 100' into receiving mode and await a response command from the remote control assembly 300.

[0153] Next, the remote control assembly 300 may transmit a matching request to the injection pump assembly 100', which may be approved by the injection pump assembly 100'. The injection pump assembly 100' may perform a security check on the matching request received from the remote control assembly 300, and (if the security check passes) the injection pump assembly 100' may activate the pump matching signal (i.e., enter active matching mode). The remote control assembly 300 may perform a security check on the approval received from the injection pump assembly 100'.

[0154] The approval received from the injection pump assembly 100' may specify the serial number of the injection pump assembly 100', and the remote control assembly 300 may display that serial number on the display assembly 302 on the remote control assembly 300. The user may be asked if they wish to match the found pump. If the user declines, the matching process may be interrupted. If the user agrees to the matching process, the remote control assembly 300 may prompt the user (via the display assembly 302) to press and hold the switch assembly 318 on the injection pump assembly 100'.

[0155] The user then presses and holds down the switch assembly 318 on the injection pump assembly 100', and may also press and hold down the switch assembly 310 on the remote control assembly 300, for example.

[0156] The remote control assembly 300 may confirm that the remote switch assembly 310 has been pressed (this may be reported to the injection pump assembly 100'). The injection pump assembly 100' may perform a security check on the confirmation received from the remote control assembly 300 to verify the integrity of the confirmation. If the integrity of the received confirmation cannot be verified, the pairing process is interrupted. If the integrity of the received confirmation is verified, any existing remote pair configuration files are overwritten to reflect the newly paired remote control assembly 300, the pump pairing complete signal is activated, and the pairing process is completed.

[0157] In addition, the injection pump assembly 100' may confirm that the switch assembly 318 has been pressed (this may be reported to the remote control assembly 300). The remote control assembly 300 may perform a security check on the confirmation received from the injection pump assembly 100' to verify the integrity of the confirmation. If the integrity of the received confirmation cannot be verified, the pairing process is interrupted. If the integrity of the received confirmation can be verified, the pairlist file in the remote control assembly 300 may be modified to add the injection pump assembly 100'. Typically, the remote control assembly 300 may be able to pair with multiple injection pump assemblies, while the injection pump assembly 100' may only be able to pair with a single remote control assembly. A pairing completion signal may be activated to complete the pairing process.

[0158] Once the pairing process is complete, one or more of the remote control assembly 300 and the injection pump assembly 100' may generate an audible signal indicating that the pairing procedure described above has been successfully completed.

[0159] Step to interrupt bolus dose: If the user wishes to interrupt the bolus dose of insulin being administered by, for example, the infusion pump assembly 100', the user may press the switch assembly 318 (for example, shown in Figures 1 and 2) for a specified period of time, for example, more than 5 seconds. Once this specified period has been reached, the infusion pump assembly 100' may render an audible signal indicating that the above interruption procedure has been achieved.

[0160] The switch assembly 318 is shown positioned on top of the injection pump assemblies 100, 100', but other configurations are possible, and this is for illustrative purposes only and is not intended to limit the disclosure. For example, the switch assembly 318 may be positioned around the injection pump assemblies 100, 100'.

[0161] See also Figures 13-15, which show an alternative embodiment of the injection pump assembly 400. Similar to pump assemblies 100, 100', the injection pump assembly 400 may include a reusable housing assembly 402 and a disposable housing assembly 404.

[0162] Similar to the reusable housing assembly 102, the reusable housing assembly 402 includes a mechanical control assembly (including at least one pump assembly and at least one valve assembly). The reusable housing assembly 402 may also include an electrical control assembly configured to provide control signals to the mechanical control assembly to achieve delivery of injectable fluid to the user. The valve assembly may be configured to control the flow of injectable fluid through a fluid path, and the pump assembly may be configured to deliver injectable fluid from the fluid path to the user.

[0163] Similar to the disposable housing assembly 114, the disposable housing assembly 404 may be configured for single use or for use over a specified period, for example, three days or any other amount of time. The disposable housing assembly 404 may be configured such that any components of the injection pump assembly 400 that come into contact with the injectable fluid are located on and / or inside the disposable housing assembly 404.

[0164] In a particular embodiment of this injection pump assembly, the injection pump assembly 400 may include a switch assembly 406 positioned around the injection pump assembly 400. For example, the switch assembly 406 may be positioned along the radial edge of the injection pump assembly 400 to allow for easier use by the user. The switch assembly 406 may be covered with a waterproof membrane configured to prevent water from penetrating into the injection pump assembly 400. The reusable housing assembly 402 may include a main body portion 408 (which houses the mechanical and electrical control assemblies described above) and a locking ring assembly 410 which may be configured to rotate around the main body portion 408 (in the direction of arrow 412).

[0165] Similar to the reusable housing assembly 102 and the disposable housing assembly 114, the reusable housing assembly 402 may be configured to releasably engage with the disposable housing assembly 404. Such a releasable engagement may be achieved, for example, by a screw, twist-lock, or compression-fit configuration. In embodiments where a twist-lock configuration is utilized, the user of the injection pump assembly 400 may first properly position the reusable housing assembly 402 relative to the disposable housing assembly 404, and then rotate the locking ring assembly 410 (in the direction of arrow 412) to releasably engage the reusable housing assembly 402 with the disposable housing assembly 404.

[0166] Through the use of the locking ring assembly 410, the reusable housing assembly 402 may be properly positioned relative to the disposable housing assembly 404 and then releasably engaged by rotating the locking ring assembly 410, thus eliminating the need to rotate the reusable housing assembly 402 relative to the disposable housing assembly 404. Therefore, the reusable housing assembly 402 may be properly aligned with the disposable housing assembly 404 before engagement, and such alignment should not be hindered during the engagement process. The locking ring assembly 410 may include a latch mechanism (not shown) that prevents rotation of the locking ring assembly 410 until the reusable housing assembly 402 and the disposable housing assembly 404 are properly positioned relative to each other.

[0167] See also Figures 199A–199D, another embodiment of the locking ring assembly 19900 is shown. As shown in Figures 199C–199D, this embodiment of the locking ring assembly 19900 includes a spring 19902 and a tab 19904, together forming a spring-loaded mutual locking tab. The spring-loaded mutual locking tab also includes a housing for a magnet 19906. The spring-loaded mutual locking tab provides improved cover mutual locking as the spring-loaded mutual locking tab floats and provides a snap-fit. Still referring to Figures 199C–199D, the locking ring assembly 19900 also includes elastic outer coverings 19908, 19910. In the illustrative embodiment of the locking ring assembly 19900, the rigid core 19901 of the locking ring assembly is made of plastic. In addition, the spring-loaded mutual locking tab 19904 that houses the magnet 19906 positions the magnet 19906 in a position closer to the switch with which it interacts. Furthermore, the spring-loaded mutual locking tab of the locking ring assembly 19900 releases the reusable part of the pump assembly from force when the disposable part is removed from the reusable part of the pump assembly.

[0168] See also Figures 16-18, which show an alternative embodiment of the injection pump assembly 500. Similar to pump assemblies 100, 100', the injection pump assembly 500 may include a reusable housing assembly 502 and a disposable housing assembly 504.

[0169] Similar to the reusable housing assembly 402, the reusable housing assembly 502 includes a mechanical control assembly (including at least one pump assembly and at least one valve assembly). The reusable housing assembly 502 may also include an electrical control assembly configured to provide control signals to the mechanical control assembly to achieve delivery of injectable fluid to the user. The valve assembly may be configured to control the flow of injectable fluid through a fluid path, and the pump assembly may be configured to deliver injectable fluid from the fluid path to the user.

[0170] Similar to the disposable housing assembly 404, the disposable housing assembly 504 may be configured for single use or for use over a specified period, for example, three days or any other amount of time. The disposable housing assembly 504 may be configured such that any components of the injection pump assembly 500 that come into contact with the injectable fluid are located on and / or inside the disposable housing assembly 504.

[0171] In certain embodiments of this injection pump assembly, the injection pump assembly 500 may include a switch assembly 506 positioned around the injection pump assembly 500. For example, the switch assembly 506 may be positioned along the radial edge of the injection pump assembly 500, which may allow for easier use by the user. The switch assembly 506 may be covered with a waterproof membrane and / or may include an O-ring or other sealing mechanism configured to prevent water from penetrating into the injection pump assembly 500 on the handle portion 507 of the switch assembly 506. However, in some embodiments, the switch assembly 506 may include an externally coated rubber button, thus providing functionality as a waterproof seal without the use of a waterproof membrane or O-ring. However, in yet other embodiments, the externally coated rubber button may, in addition, be covered with a waterproof membrane and / or include an O-ring. The reusable housing assembly 502 may include a main body portion 508 (for housing the mechanical and electrical control assemblies described above) and a locking ring assembly 510, which may be configured to rotate around the main body portion 508 (in the direction of arrow 512).

[0172] Similar to the reusable housing assembly 402 and the disposable housing assembly 404, the reusable housing assembly 502 may be configured to releasably engage with the disposable housing assembly 504. Such a releasable engagement may be achieved, for example, by a screw, twist-lock, or compression-fit configuration. In embodiments where a twist-lock configuration is utilized, the user of the injection pump assembly 500 may first properly position the reusable housing assembly 502 relative to the disposable housing assembly 504, and then rotate the locking ring assembly 510 (in the direction of arrow 512) to releasably engage the reusable housing assembly 502 with the disposable housing assembly 404.

[0173] Since the locking ring assembly 510 contained within the injection pump assembly 500 may be higher than the locking ring assembly 410 (i.e., as indicated by arrow 514), the locking ring assembly 510 may include a passage 516 through which the button 506 may pass. Therefore, when assembling the reusable housing assembly 502, the locking ring assembly 510 may be placed on top of the main body portion 508 (in the direction of arrow 518). Once the locking ring assembly 510 is placed on top of the main body portion 508, one or more locking tabs (not shown) may prevent the locking ring assembly 510 from being removed from the main body portion 508. The portion of the switch assembly 506 protruding through the passage 516 may then be pushed into the main body portion 508 (in the direction of arrow 520), thus completing the installation of the switch assembly 506.

[0174] Although the button 506 is shown in various locations on the injection pump assembly 500, in other embodiments, the button 506 may be located in any desired location on the injection pump assembly 500.

[0175] Through the use of the locking ring assembly 510, the reusable housing assembly 502 may be properly positioned relative to the disposable housing assembly 504 and then releasably engaged by rotating the locking ring assembly 510, thus eliminating the need to rotate the reusable housing assembly 502 relative to the disposable housing assembly 504. Therefore, the reusable housing assembly 502 may be properly aligned with the disposable housing assembly 504 before engagement, and such alignment should not be hindered during the engagement process. The locking ring assembly 510 may include a latch mechanism (not shown) to prevent rotation of the locking ring assembly 510 until the reusable housing assembly 502 and the disposable housing assembly 504 are properly positioned relative to each other. The passage 516 may be elongated to allow movement of the locking ring 510 around the switch assembly 506.

[0176] See also Figures 19A–19B and 20–21, which show various diagrams of the injection pump assembly 500, which is shown to include a reusable housing assembly 502, a switch assembly 506, and a main body portion 508. As discussed above, the main body portion 508 may include multiple components, including, but not limited to, a capacitance sensor assembly 148, a printed circuit board 600, a vibration motor assembly 602, a shape memory actuator anchor 604, a switch assembly 506, a battery 606, an antenna assembly 608, a pump assembly 106, a measuring valve assembly 610, a capacitance sensor valve assembly 612, and a reservoir valve assembly 614. For clarity, the printed circuit board 600 has been removed from Figure 19B to allow visibility of the various components located beneath the printed circuit board 600.

[0177] Various electrical components that may be electrically connected to the printed circuit board 600 may include spring-loaded terminals that enable electrical connection without the need for soldering. For example, the vibration motor assembly 602 may utilize a pair of spring-loaded terminals (one positive terminal and one negative terminal) configured to press against corresponding conductive pads on the printed circuit board 600 when the vibration motor assembly 602 is positioned on the printed circuit board 600. However, in the illustrative embodiment, the vibration motor assembly 602 is soldered directly to the printed circuit board.

[0178] As discussed above, the capacity sensor assembly 148 may be configured to monitor the amount of fluid injected by the injection pump assembly 500. For example, the capacity sensor assembly 148 may employ acoustic capacity sensing, which is the subject of U.S. Patent Nos. 5,575,310 and 5,755,683, assigned to DEKA Products Limited Partnership, and U.S. Patent Publications US2007 / 0228071A1, US2007 / 0219496A1, 2007 / 0219480A1, and U.S. Patent Publication Nos. US2007 / 0219597A1, which are incorporated herein by reference in their entirety.

[0179] The vibration motor assembly 602 may be configured to provide vibration-based signals to the user of the injection pump assembly 500. For example, if the voltage of the battery 606 (which powers the injection pump assembly 500) falls below the minimum allowable voltage, the vibration motor assembly 602 may be configured to vibrate the injection pump assembly 500 to provide vibration-based signals to the user of the injection pump assembly 500. The shape memory actuator anchor 604 may provide a mounting point for the shape memory actuator (e.g., shape memory actuator 112). As discussed above, the shape memory actuator 112 may be, for example, a conductive shape memory alloy wire that changes shape with temperature. The temperature of the shape memory actuator 112 may be changed by a heater or, more conveniently, by the application of electrical energy. Thus, one end of the shape memory actuator 112 may be firmly attached (i.e., fixed) to the shape memory actuator anchor 604, and the other end of the shape memory actuator 112 may be applied to, for example, a valve assembly and / or a pump actuator. Thus, the length of the shape memory actuator 112 may be controlled by applying electrical energy to the shape memory actuator 112, and therefore the valve assembly and pump actuator to which it is attached may be operated.

[0180] The antenna assembly 608 may be configured to enable wireless communication between, for example, the injection pump assembly 500 and the remote control assembly 300 (Figure 11). As discussed above, the remote control assembly 300 may allow a user to program the injection pump assembly 500 to configure, for example, a bolus injection event. As discussed above, the injection pump assembly 500 may include one or more valve assemblies configured to control the flow rate of injectable fluid through the fluid path (within the injection pump assembly 500), and the pump assembly 106 may be configured to deliver injectable fluid from the fluid path to the user. In a particular embodiment of this injection pump assembly 500, it has been shown that the injection pump assembly 500 includes three valve assemblies, namely, a measuring valve assembly 610, a capacity sensor valve assembly 612, and a reservoir valve assembly 614.

[0181] As discussed above, and also with reference to Figure 21, the injectable fluid may be stored in the reservoir 118. To achieve delivery of the injectable fluid to the user, processing logic (not shown) contained within the injection pump assembly 500 may activate a shape memory actuator 112, which may be fixed on one end using a shape memory actuator anchor 604. Also with reference to Figure 22A, the shape memory actuator 112 may result in the activation of the pump assembly 106 and the reservoir valve assembly 614. The reservoir valve assembly 614 may include a reservoir valve actuator 614A and a reservoir valve 614B, and the activation of the reservoir valve assembly 614 may result in the downward displacement of the reservoir valve actuator 614A and the closure of the reservoir valve 614B, resulting in effective isolation of the reservoir 118. Furthermore, the pump assembly 106 may include a pump plunger 106A and a pump chamber 106B, and starting the pump assembly 106 may result in the displacement of the pump plunger 106A, which is displaced downward into the pump chamber 106B, and the injectable fluid (in the direction of arrow 616).

[0182] The capacity sensor valve assembly 612 may include a capacity sensor valve actuator 612A and a capacity sensor valve 612B. See also Figure 22B, the capacity sensor valve actuator 612A may be closed via a spring assembly that provides mechanical force to seal the capacity sensor valve 612B. However, when the pump assembly 106 is activated, if the displaced injectable fluid is at sufficient pressure to overcome the mechanical sealing force of the capacity sensor valve assembly 612, the displacement of the injectable fluid occurs in the direction of arrow 618. This may result in filling of the capacity sensor chamber 620 contained within the capacity sensor assembly 148. The volume of the injectable fluid contained within the capacity sensor chamber 620 may be determined through the use of a speaker assembly 622, a port assembly 624, a reference microphone 626, a spring diaphragm 628, a constant capacity microphone 630, and the capacity sensor assembly 148.

[0183] See also Figure 22C. Once the volume of the injectable fluid contained in the volume sensor chamber 620 is calculated, the shape memory actuator 632 is energized, which may result in the activation of a measuring valve assembly 610, which may include a measuring valve actuator 610A and a measuring valve 610B. Once activated, and due to the mechanical energy exerted on the injectable fluid in the volume sensor chamber 620 by the spring diaphragm 628, the injectable fluid in the volume sensor chamber 620 may be displaced into the user's body (in the direction of arrow 634) through a disposable cannula 138.

[0184] See also Figure 23, which shows an exploded view of the injection pump assembly 500. The shape memory actuator 632 may be fixed (on its first end) to the shape memory actuator anchor 636. In addition, the other end of the shape memory actuator 632 may be used to provide mechanical energy to a valve assembly 638, which may activate the measuring valve assembly 610. The capacity sensor assembly spring retainer 642 may properly position the capacity sensor assembly 148 relative to various other components of the injection pump assembly 500. The valve assembly 638 may be used in conjunction with the shape memory actuator 112 to activate the pump plunger 106A. The measuring valve 610B, the capacity sensor valve 612B, and / or the reservoir valve 614B may be built-in valves configured to allow installation during the assembly of the injection pump assembly 500 by pushing the valve upward into the underside of the main body portion 508.

[0185] See also Figures 24 and 25A-25D for a more detailed view of the pump assembly 106. The pump actuator assembly 644 may include a pump actuator support structure 646, a biasing spring 648, and a lever assembly 650.

[0186] See also Figures 26A-26B and 27A-27B for a more detailed view of the measuring valve assembly 610. As discussed above, the valve assembly 638 may activate the measuring valve assembly 610.

[0187] See also Figures 28A-28D, the injection pump assembly 500 may include a measuring valve assembly 610. As discussed above, the valve assembly 638 may be activated via a shape memory actuator 632 and an actuator assembly 640. Thus, the shape memory actuator 632 may need to activate the valve assembly 638 for a considerable period of time (e.g., more than one minute) in order to inject the amount of injectable fluid stored in the volume sensor chamber 620. Since this consumes a considerable amount of power from the battery 606, the measuring valve assembly 610 may allow for a temporary activation of the valve assembly 638, at which point the measuring valve latch 656 may prevent the valve assembly 638 from returning to its non-activated position. The shape memory actuator 652 may be fixed on the first end using an electrical contact 654. The other end of the shape memory actuator 652 may be connected to the valve latch 656. When the shape memory actuator 652 is activated, it may pull the valve latch 656 forward and release the valve assembly 638. In this manner, the measuring valve assembly 610 may be activated via the shape memory actuator 632. Once the measuring valve assembly 610 is activated, the valve latch 656 may automatically latch onto the valve assembly 638 in the activated position. The shape memory actuator 652 may be activated to pull the valve latch 656 forward and release the valve assembly 638. Assuming the shape memory actuator 632 is no longer activated, the measuring valve assembly 610 may enter a deactivated state once the valve latch 656 has released the valve assembly 638. Therefore, throughout the use of the measuring valve assembly 610, the shape memory actuator 632 does not need to be activated during the entire time required to inject the amount of injectable fluid stored in the volume sensor chamber 620.

[0188] See also Figures 201A-201B, which illustrate an exemplary embodiment of the measuring valve assembly. In this embodiment, the valve latch described above with respect to Figures 26A-26B and 28A-28C is removed. This exemplary embodiment eliminates the noise produced by the pump when the latch is actuated. In addition, removing the latch eliminates the risk of a faulty valve latch and reduces the failure of the measuring valve due to potential shape memory alloy fatigue. In terms of manufacturing, the removal of the valve latch reduces component costs and assembly costs by eliminating an assembly step. In addition, the removal of the valve latch may reduce power consumption.

[0189] As discussed above, the injection pump assemblies (e.g., injection pump assemblies 100, 100', 400, 500) may include an external injection set 134 configured to deliver an injectable fluid to the user. The external injection set 134 may include a cannula assembly 136, which may include a needle or disposable cannula 138 and a tubing assembly 140. The tubing assembly 140 may be in fluid communication with the reservoir 118, for example, through a fluid path, and with the cannula assembly 138, for example, directly or through a cannula interface 142.

[0190] See also Figure 29, which shows an alternative embodiment of an injection pump assembly 700 configured to house a portion of the tubing assembly 140. Specifically, the injection pump assembly 700 may include a peripheral tubing storage assembly 702 configured to allow a user to wind a portion of the tubing assembly 140 around the injection pump assembly 700 (similar to a yo-yo). The peripheral tubing storage assembly 702 may be positioned around the injection pump assembly 700. The peripheral tubing storage assembly 702 may be configured as an open valley into which a portion of the tubing assembly 140 may be wound. Alternatively, the peripheral tubing storage assembly 702 may include one or more segmented portions 704, 706 that form a plurality of narrower valleys, which may be sized to create an interference fit between the walls of the narrower valleys and the outer surface of a portion of the tubing 140. When the peripheral pipe storage assembly 705 includes multiple divisions 704, 706, the resulting narrower valleys may be spirally wound around the injection pump assembly 700 (similar to the threads of a screw).

[0191] See also Figures 30-31, which show an alternative embodiment of an injection pump assembly 750 configured to house a portion of the tubing assembly 140. Specifically, the injection pump assembly 750 may include a peripheral tubing storage assembly 752 configured to allow a user to wind a portion of the tubing assembly 140 around the injection pump assembly 750 (again, similarly to a yo-yo). The peripheral tubing storage assembly 752 may be positioned around the injection pump assembly 750. The peripheral tubing storage assembly 752 may be configured as an open valley into which a portion of the tubing assembly 140 may be wound. Alternatively, the peripheral tubing storage assembly 752 may include one or more segmented portions 754, 756 that form a plurality of narrower valleys, which may be sized to create an interference fit between the walls of the narrower valleys and the outer surface of a portion of the tubing 140. When the peripheral pipe storage assembly 752 includes multiple divisions 754, 756, the resulting narrower valleys may be spirally wound around the injection pump assembly 750 (again, similar to screw threads).

[0192] The injection pump assembly 750 may include a pipe retainer assembly 758. The pipe retainer assembly 758 may be configured to releasably secure the pipe assembly 140 so as to prevent it from unraveling around the injection pump assembly 750. In one embodiment of the pipe retainer assembly 758, the pipe retainer assembly 758 may include a downward-facing pin assembly 760 positioned above an upward-facing pin assembly 762. The combination of pin assemblies 760, 762 may define a "pinch point" through which the pipe assembly 140 may be pushed. Thus, the user may wrap the pipe assembly 140 around the injection pump assembly 750, with each loop of the pipe assembly 140 secured within the peripheral pipe storage assembly 752 via the pipe retainer assembly 758. If the user wishes to extend the unfixed portion of the pipe assembly 140, the user may release one loop of the pipe assembly 140 from the pipe retainer assembly 758. Conversely, if the user wishes to shorten the unfixed portion of the pipe assembly 140, the user may fix one additional loop of the pipe assembly 140 from the pipe retainer assembly 758.

[0193] See also Figures 32-33, which illustrate an exemplary embodiment of the injection pump assembly 800. Similar to injection pump assemblies 100, 100', 400, and 500, the injection pump assembly 800 may include a reusable housing assembly 802 and a disposable housing assembly 804.

[0194] See also Figures 34A-34B, similar to the injection pump assembly 100, the reusable housing assembly 802 may be configured to releasably engage with the disposable housing assembly 804. Such a releasable engagement may be achieved, for example, by a screw, twist-lock, or compression-fit configuration. The injection pump assembly 800 may include a locking ring assembly 806. For example, the reusable housing assembly 802 may be properly positioned relative to the disposable housing assembly, and the locking ring assembly 806 may be rotated to releasably engage with both the reusable housing assembly 802 and the disposable housing assembly 804.

[0195] The locking ring assembly 806 may include a knot 808 that facilitates the rotation of the locking ring assembly 806. In addition, for example, the position of the knot 808 relative to the tab 810 of the disposable housing assembly 804 may provide verification that the reusable housing assembly 802 is fully engaged with the disposable housing assembly 804. For example, when the reusable housing assembly 802 is properly aligned with the disposable housing assembly 804, as shown in Figure 34A, the knot 808 may be aligned in a first position relative to the tab 810. Once the fully engaged state is achieved, the rotation of the locking ring assembly 806 may cause the knot 808 to be aligned in a second position relative to the tab 810, as shown in Figure 34B.

[0196] See also Figures 35A-35C and 36-38A, similar to the reusable housing assembly 102, the reusable housing assembly 802 may include a mechanical control assembly 812 (which may include a valve assembly 814 shown in Figure 36, for example, including one or more valves and one or more pumps for dispensing and controlling the flow rate of injectable fluid). The reusable housing assembly 802 may also include an electrical control assembly 816, which may be configured to provide control signals to the mechanical control assembly 812 and to achieve delivery of injectable fluid to the user. The valve assembly 814 may be configured to control the flow rate of injectable fluid through the fluid path, and the pump assembly may be configured to dispensing injectable fluid from the fluid path to the user.

[0197] The mechanical control assembly 812 and the electrical control assembly 816 may be contained within a housing defined by a substrate 818 and a body 820. In some embodiments, one or more of the substrate 818 and the body 820 may provide electromagnetic shielding. In such embodiments, the electromagnetic shielding may prevent and / or reduce electromagnetic interference received by and / or generated by the electrical control assembly 816. In addition / alternatively, an EMI shielding body 822 may be included, as shown in Figures 36 and 37. The EMI shielding body 822 may provide shielding against generated and / or received electromagnetic interference.

[0198] The reusable housing assembly 802 may include a switch assembly which may be configured to receive user commands (e.g., for bolus delivery, matching with a remote control assembly). The switch assembly may include a button 824 which may be located in an opening 826 of the body 820. For example, as shown in Figure 35B, the locking ring assembly 806 may include radial slots 828 which may be configured to allow the locking ring assembly 806 to rotate relative to the body 820 while still providing easy access to the button 824.

[0199] See also Figures 39A-39C, the electrical control assembly 816 may include a printed circuit board 830 and a battery 832. The printed circuit board 830 may include various control electronics for monitoring and controlling the amount of injectable fluid that has been and / or is being dispensed. For example, the electrical control assembly 816 may measure the amount of injectable fluid that has just been dispensed and determine whether a sufficient amount of injectable fluid has been dispensed based on the dose required by the user. If a sufficient amount of injectable fluid has not been dispensed, the electrical control assembly 816 may determine that more injectable fluid should be dispensed. The electrical control assembly 816 may provide appropriate signals to the mechanical control assembly 812 so that additional required doses may be dispensed, or the electrical control assembly 816 may provide appropriate signals to the mechanical control assembly 812 so that additional doses may be dispensed together with the next dose. Alternatively, if an excess amount of injectable fluid is dispensed, the electrical control assembly 816 may provide an appropriate signal to the mechanical control assembly 812 so that a smaller amount of injectable fluid may be dispensed in the next dose. The electrical control assembly 816 may include one or more microprocessors. In an illustrative embodiment, the electrical control assembly 816 may include three processors. One processor (for example, a CC2510 microcontroller / RF transceiver available from Chipcon AS (Oslo, Norway) may be dedicated to wireless communication, for example, to communicate with the remote control assembly. Two additional microprocessors (for example, an MSP430 microcontroller available from Texas Instruments Inc. (Dallas, Texas) may be dedicated to issuing and executing commands (for example, to dispense doses of injectable fluid, process feedback signals from volumetric devices, etc.).

[0200] As shown in Figure 35C, the substrate 818 may provide access to electrical contacts 834, which may be electrically coupled to the electrical control assembly 816 for, for example, recharging the battery 832. The substrate 818 may include one or more features (e.g., openings 836, 838) configured to facilitate proper alignment with the disposable housing assembly 804 via cooperative features (e.g., tabs) of the disposable housing assembly 804. In addition, as shown in Figures 40A-40C, 41A-41B, and 42A-42C, the substrate 818 may include various features for mounting the valve assembly 814 and the electrical control assembly 816, and for providing access to the disposable housing assembly 804 by the valve assembly 814.

[0201] The locking ring assembly 806 may include grip inserts 840, 842, which may include elastic or molded material, to facilitate gripping and twisting the locking ring assembly 806, for example, to engage / disengage the reusable housing assembly 802 and the disposable housing assembly 804. In addition, the locking ring assembly 806 may include sensing components (e.g., magnets 844) that interact with components of the reusable housing assembly 802 (e.g., Hall effect sensors) to provide an indicator of the properties of the engaging components (e.g., in some embodiments, one or more of the disposable housing assembly 804, charging stations, or filling stations) and / or whether the reusable housing assembly 802 is properly engaged with the engaging components. In an illustrative embodiment, a Hall effect sensor (not shown) may be located on a pump printed circuit board. The Hall effect sensor may detect when the locking ring has been rotated to the closed position. Therefore, the Hall effect sensor, together with the magnet 844, may provide a system for determining whether the locking ring has been rotated to the closed position.

[0202] The sensing component (magnet) 844, together with the reusable housing assembly component, i.e., in an illustrative embodiment, the Hall effect sensor may operate to provide a determination of whether the reusable housing assembly is properly mounted on the intended component or device. The locking ring assembly 806 must not swivel without being mounted on a component, i.e., the disposable housing assembly 804, dust cover, or charger. Thus, the sensing component, together with the reusable housing assembly component, may function to provide several advantageous safety features to the injection pump system. These features may include, but are not limited to, one or more of the following: If the system does not detect that a disposable assembly, dust cover, or charger is not mounted, the reusable part, e.g., the valve and pump components, may be susceptible to contamination or damage, which could compromise the integrity of the reusable assembly, and the system may notify, warn, or alert the user. Thus, the system may provide an integrity alarm to warn the user of a potential threat to the integrity of the reusable assembly. Furthermore, if the system detects that a reusable assembly is attached to the dust cover, the system may save power by turning off or reducing the power. This may provide more efficient use of power when the reusable assembly is not connected to any components that need to interact with each other.

[0203] The reusable housing assembly 802 may be attached to a number of different components, including, but not limited to, a disposable housing assembly, a dust cover, or a battery charger / battery charging station. In each case, a Hall effect sensor may detect that the locking ring is in the closed position, and thus the reusable housing assembly 802 is releasably engaged to the disposable housing assembly, the dust cover, or the battery charger / battery charging station (or another component). The injection pump system may determine which component it is attached to by using an AVS system, which is described in more detail below, or by electrical contacts. See also Figures 38B-38D, an embodiment of a dust cover (e.g., dust cover 839) is shown. In an illustrative embodiment, the dust cover 839 may include features 841, 843, 845, and 847 such that the locking ring of the reusable housing assembly 802 may releasably engage with the dust cover 839. In addition, the dust cover 839 may further include recessed areas 849 for accommodating valve and pump features of the reusable housing assembly 804. For example, with respect to the dust cover, the AVS system may determine that the dust cover is connected to the reusable housing assembly rather than the disposable housing assembly. The AVS system may distinguish between using a reference table or other comparison data and comparing measurement data to data of a characteristic dust cover or an empty disposable housing assembly. With respect to the battery charger, the battery charger may include electrical contacts in an illustrative embodiment. When the reusable housing assembly is attached to the battery charger, the injection pump assembly electronic system may sense that contact has been made and thus indicate that the reusable housing assembly is attached to the battery charger.

[0204] See also Figures 43A–45B and 44A–44C, which show embodiments of the valve assembly 814, which may include one or more valves and one or more pumps. Similar to the injection pump assemblies 100, 100', 400, and 500, the valve assembly 814 may generally include a reservoir valve 850, a plunger pump 852, a volume sensor valve 854, and a measuring valve 856. As previously described, the reservoir valve 850 and the plunger pump 852 may be actuated by a shape memory actuator 858, which may be fixed (on its first end) to a shape memory actuator anchor 860. In addition, the measuring valve 856 may be actuated via a valve actuator 862 by a shape memory actuator 864, which may be fixed (on its first end) to a shape memory actuator anchor 866. As discussed above, the measuring valve may be held in the open position via a measuring valve latch assembly 868. The measuring valve 856 may be fixed (on the first end) by the shape memory actuator anchor 872, or released via the operation of the shape memory actuator 870. In some embodiments, the shape memory actuator anchor 860 may be placed on a reusable housing assembly. Using this process during manufacturing ensures that the shape memory length actuator 858 is installed and maintains the desired length and tension / strain.

[0205] See also Figures 45A-45B and 46A-46E, a shape memory actuator 858 (which may include, for example, one or more shape memory wires) may actuate a plunger pump 852 via an actuator assembly 874. The actuator assembly 874 may include a biasing spring 876 and a lever assembly 878. The actuator assembly 874 may actuate both the plunger pump 852 and the measuring valve 850.

[0206] See also Figures 47A-47B, the measuring valve 856 may be actuated by a shape memory actuator 864 via a valve actuator 862 and a lever assembly 878. Once actuated, the measuring valve latch assembly 868 may hold the measuring valve 856 in the open position. The measuring valve latch assembly 868 is actuated by a shape memory actuator 870 to release the measuring valve 856, allowing it to return to the closed position.

[0207] The disposable housing assembly 804 may be configured for single use or for use for a specified period, such as three days or any other time. The disposable housing assembly 804 may be configured such that any components in the injection pump assembly 800 that come into contact with the injectable fluid are located on and / or inside the disposable housing assembly 804. In such a way, the risk of contaminating the injectable fluid may be reduced.

[0208] See also Figures 48 and 49A-49C, the disposable housing assembly 804 may include a base portion 900, a membrane assembly 902, and an upper portion 904. The base portion 900 may include a recess 906 that, together with the membrane assembly 902, defines a reservoir 908 for receiving an injectable fluid (not shown), such as insulin. See also Figures 50A-50C, the recess 906 may be formed at least partially by the base portion 900 and be integral with it. The membrane assembly 902 may be tightly engaged with the base portion 900 by, for example, compression clamping between the base portion 900 and the upper portion 904. The upper portion 904 may be attached to the base portion 900 by conventional means such as teething, bonding, heat fusion, ultrasonic welding, and compression fitting. In addition / alternatively, the membrane assembly 902 may be attached to the base portion 900 by means of, for example, adhesive, ultrasonic welding, thermal fusion, etc., to provide a seal between the membrane assembly 902 and the base portion 900.

[0209] Still referring to Figures 48 and 50A, the recess 906, in the illustrative embodiment, includes a raised portion 901 that includes the region 903 surrounding the fluid opening 905 connected to the fluid line. In the illustrative embodiment, the raised portion 901 extends around the recess 906. However, in other embodiments, the raised portion 901 does not have to extend around the entire perimeter, but may be partially around it. The region 903 around the fluid opening 905 may, in some embodiments, be shaped as shown in the illustrative embodiment, including a portion forming an angle including a 45-degree angle, but in other embodiments, the angle may be larger or smaller. In some embodiments, the pump does not have to generate a sufficient vacuum to fold the reservoir to remove the entire volume of fluid that can be stored in the reservoir. The raised portion 901 may act to minimize wasted fluid. In some embodiments, the reservoir membrane may be made of a material having a durometer of 20A to 30A, thus providing a flexible material. In addition, in some embodiments, features including, but not limited to, raised features or meandering features around the outer wall of the reservoir may be added to the reservoir wall. Along with the soft material, one or more of these raised features may fill dead volume in the reservoir. In some embodiments, one or more raised features may be added to the reservoir. Since one or more raised features may reduce the filling capacity of the reservoir, the features may reduce dead volume which is one of the factors contributing to the reservoir's ability to become empty. In addition, in the illustrative embodiment, the reservoir includes at least one vent.

[0210] In an illustrative embodiment, the fluid opening 905 may include three openings, but in other embodiments, it may include more or fewer openings; the fluid opening 905 may be surrounded by a raised region 903. In an illustrative embodiment, the fluid opening 905 may be narrow in the center and thus generate surface tension that may prevent air from being drawn into the opening. In an illustrative embodiment, this region may be designed to encourage air present in the reservoir to be drawn above one of the fluid openings 905 rather than through the fluid opening 905 into the fluid line. In addition, there may be two or more fluid openings 905 so that if a bubble is trapped above one opening, the air does not have to prevent the fluid from flowing through the other two openings.

[0211] See also Figures 200A–200H, which illustrate another embodiment of the disposable housing assembly 20000. As described herein, the volume and delivery time are fixed for each pump stroke. Under certain circumstances, bubbles may form in the reservoir. These may be caused by many reasons, including, but not limited to, the introduction, diffusion, and / or degassing of the injectable fluid when the fluid is transferred to the reservoir. However, as discussed above, many features of the various embodiments of the reservoir mitigate or eliminate the formation of bubbles being delivered into the fluid line. However, if bubbles do form in the fluid line, they cannot affect the accuracy of the pump volume unless they are located in the volume measuring sensor and / or volume measuring chamber. Since the volume of injectable fluid being delivered is determined by volume measurement performed by the volume measuring sensor, it is desirable to eliminate any bubbles that may be present in the volume sensor chamber.

[0212] The diameter of the fluid line, the fluid velocity, and the surface tension are at least three factors that affect the ability to prevent bubble trapping. Given that the surface tension of the injectable fluid is fixed, increasing the velocity or decreasing the diameter can contribute to mitigating trapped bubbles. Therefore, increasing the fluid velocity can be achieved by decreasing the diameter of the fluid line.

[0213] Still referring to the disposable portion 20000 embodiments shown in Figures 200A-200H, the fluid line holes in the volume measuring sensor are not tapered and have a diameter of 0.020 inches in the exemplary embodiments. However, in other embodiments, the diameter may be between 0.018 and 0.020 inches. A diameter of 0.020 inches reduces the probability of bubbles being trapped in the volume measuring chamber. In other embodiments, in addition to other elements, other diameters and / or various materials and / or geometric shapes, as well as variations in the pump mechanism, may be used to reduce the probability of bubbles being trapped.

[0214] See also Figures 51A-51C, the disposable housing assembly 804 may also include a fluid path cover 910. The fluid path 910 may be housed in a cavity 912 formed on / inside the base portion 900. In some embodiments, the fluid path 910 may include at least a portion of one or more channels (e.g., channel 914). The channels included in the fluid path cover 910 may fluidly connect to one or more volcano valve features (e.g., volcano valve 916) included on the base portion 900. The volcano valve 916 may include a projection having an opening extending through it. In addition, the fluid path cover 910 and the base portion 900 may each define a portion of a recess (e.g., recessed portions 918, 920, included in the base portion 900 and the fluid path cover 910, respectively) for fluid connection to an injection set (e.g., including a cannula 922). The cannula 922 may be connected to the disposable housing assembly 804 by conventional means (e.g., adhesive, heat fusion, compression fitting, etc.). The fluid path, defined by the fluid path cover 910 and the volcano valve (e.g., volcano valve 916) of the base portion 900, may define a fluid path between the reservoir 908 and the cannula 922 for the delivery of injectable fluid to the user via the injection set. However, in some embodiments, the fluid path cover 910 may include at least a portion of the fluid path, and in some embodiments, the fluid path cover 910 may not include at least a portion of the fluid path. In an illustrative embodiment, the fluid path cover 910 may be laser welded to the base portion 900. However, in other embodiments, the fluid path cover 910 may also be connected to the base portion 900 by conventional means (e.g., adhesive, heat fusion, ultrasonic welding, compression fitting, etc.) to achieve a substantially fluid-sealed seal between the fluid path cover 910 and the base portion 900.

[0215] See also Figures 54A-54C, the disposable housing assembly 804 may further include a valve cover 924. The valve cover 924 may be positioned at least partially on / inside the base portion 900 over a volcano valve (e.g., volcano valve 916) and a pump recess 926. The valve cover 924 may include a flexible material which may be selectively engaged with the volcano valve by, for example, a reservoir valve 850, a volume sensor valve 854, and a measuring valve 856 of the reusable housing assembly 802 to control the flow rate of the injectable fluid. In addition, the valve cover 924 may be elastically deformed into the pump recess 926 by a plunger pump 852 to achieve the delivery of the injectable fluid. The valve cover 924 may be engaged between the base portion 900 and the uppermost portion 904 of the disposable housing assembly 804 to form a seal 928 between the valve cover 924 and the base portion 900. For example, in an illustrative embodiment, the valve cover 924 may be externally covered on the base portion 900. In another embodiment, the valve cover 924 may be compressed and clamped between the base portion 900 and the uppermost portion 904 to form a seal 928. In addition / alternatively, the valve insert may be connected to one or more of the base portion 900 and the uppermost portion 904 by means of, for example, adhesive, heat fusion, etc.

[0216] See also Figures 53A-C, the uppermost portion 904 may include alignment tabs 930, 932, which may be configured to be at least partially received in the openings 836, 838 of the substrate 818 of the reusable housing assembly 802, in order to ensure proper alignment between the reusable housing assembly 802 and the disposable housing assembly 804. In addition, the uppermost portion 904 may include one or more radial tabs 934, 936, 938, 940, which are configured to be engaged by the cooperating tabs 942, 944, 946, 948 of the locking ring assembly 806. One or more radial tabs (e.g., radial tab 940) may include a stopper (e.g., an alignment tab stopper 950, which may be used for welding, a tab that fits into a recess for positioning and ultrasonic welding), which may prevent further rotation of the locking ring assembly 806 once the reusable housing assembly 802 and the disposable housing assembly 804 are fully engaged.

[0217] As discussed above, the valve insert 924 may enable the delivery and flow of an injectable fluid by the reservoir valve 850, plunger pump 852, volume sensor valve 854, and measuring valve 856. Accordingly, the uppermost portion 904 may include one or more openings (e.g., openings 952, 954, 956) that can expose at least a portion of the valve insert 924 for operation by the reservoir valve 850, plunger pump 852, volume sensor valve 854, and measuring valve 856. In addition, the uppermost portion 904 may include one or more openings 958, 960, 962 that can be configured to allow the filling volume to be controlled during filling of the reservoir 908, as will be discussed in more detail below. The reservoir assembly 902 may include ribs 964, 966, 968 that can at least partially receive one of the respective openings 958, 960, 962 (e.g., as shown in Figure 52A). As will be described in more detail below, a force may be applied to one or more of the ribs 964, 966, and 968 to reduce the capacity of the reservoir 908, at least temporarily.

[0218] In some embodiments, it may be desirable to provide a seal between the reusable housing assembly 802 and the disposable housing assembly 804. Therefore, the disposable housing assembly 804 may include a sealing assembly 970. The sealing assembly 970 may include an elastomer member, for example, which, when engaged, provides a compressible rubber or plastic layer between the reusable housing assembly 802 and the disposable housing assembly 804, thus preventing accidental engagement and disengagement and penetration by external fluids. For example, the sealing assembly 970 may be a watertight assembly, thus allowing the user to wear the injection pump assembly 800 while swimming, bathing, or exercising.

[0219] For example, similar to the disposable housing assembly 114, the disposable housing assembly 802 may, in some embodiments, be configured to allow the reservoir 908 to be filled multiple times. However, in some embodiments, the disposable housing assembly 114 may be configured so that the reservoir 908 is not refilled. See also Figures 57-64, the filling adapter 1000 may be configured to connect to the disposable housing assembly 804 for refilling the reservoir 908 using a syringe (not shown). The filling adapter 1000 may include locking tabs 1002, 1004, 1006, 1008, which may be configured to engage with the radial tabs 934, 936, 938, 940 of the disposable housing assembly 804, substantially the same as the tabs 942, 944, 946, 948 of the locking ring 806. Therefore, the filling adapter 1000 may be releasably engaged with the disposable housing assembly 804 by rotating the filling adapter 1000 and the disposable housing assembly 804 relative to each other so that the filling adapter 1000 aligns with the disposable housing assembly 804 and the locking tabs 1002, 1004, 1006, 1008 releasably engage with the radial tabs 934, 936, 938, 940.

[0220] The filling adapter 1000 may further include a filling aid 1010, which may include a guide passage 1012 configured to guide, for example, the needle of a syringe (not shown) to the partition of the disposable housing assembly 804, thereby enabling the reservoir 908 of the disposable housing assembly 804 to be filled by the syringe. In some embodiments, the guide passage 1012 may be an angled slope or other stepped angled slope to further guide the syringe to the partition. The filling adapter 1000 may facilitate filling the reservoir 908 by providing a relatively large insertion area at the distal opening of the guide passage 1012, for example. The guide passage 1012 may generally taper to a smaller proximal opening, which may be properly aligned with the partition of the disposable housing assembly 804 when the filling adapter 1000 engages with the disposable housing assembly 804. Therefore, the filling adapter 1000 may reduce the dexterity and objective required to properly insert the needle through the partition of the disposable housing assembly 804 for the purpose of filling the reservoir 908.

[0221] As discussed above, the disposable housing assembly 804 may be configured to facilitate control of the amount of injectable fluid delivered to the reservoir 908 during filling. For example, the membrane assembly 902 of the disposable housing assembly 804 may include ribs 964, 966, 968 that can be pressed and displaced at least partially into the reservoir 908, thereby reducing the capacity of the reservoir 908. Thus, when injectable fluid is delivered to the reservoir 908, the capacity of fluid that can be contained by the reservoir 908 may be reduced accordingly. The ribs 964, 966, 968 may be accessible through openings 958, 960, 962 in the uppermost portion 904 of the disposable housing assembly 804.

[0222] The filling adapter 1000 may include one or more button assemblies (e.g., button assemblies 1014, 1016, 1018) corresponding to ribs 964, 966, and 968. In other words, when the filling adapter 1000 is releasably engaged with the disposable housing assembly 804, the buttons 1014, 1016, and 1018 may be aligned with the ribs 964, 966, and 968. The button assemblies 1014, 1016, and 1018 may be, for example, cantilever members that can be pressed. When the filling adapter 1000 is releasably engaged with the disposable housing assembly 804, one or more of the button assemblies 1014, 1016, and 1018 may be pressed, in which case one of each of the ribs 964, 966, and 968 may be displaced into the reservoir 908, causing an accompanying reduction in the capacity of the reservoir 908.

[0223] For example, for illustrative purposes, assume that the reservoir 908 has a maximum capacity of 3.00 mL. Furthermore, assume that the button assembly 1014 is configured to displace the rib 964 into the disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Furthermore, assume that the button assembly 1016 is configured to displace the rib 966 into the disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Furthermore, assume that the button assembly 1018 is configured to displace the slot assembly 968 into the disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Therefore, if the user wishes to fill the reservoir 908 in the disposable housing assembly 804 with 2.00 mL of injectable fluid, in some embodiments the user may first fill the reservoir to a volume of 3.00 mL and then press the button assemblies 1016 and 1014 (resulting in the displacement of the rib 966 into the disposable housing assembly 804) to effectively reduce the volume of the reservoir 908 in the disposable housing assembly 804 from 3.00 mL to 2.00 mL. In some embodiments the user may first press each of the number of button assemblies to effectively reduce the volume of the reservoir 908 and then fill the reservoir 908. A specific number of button assemblies is shown to represent the illustrative embodiment, but in other embodiments the number of button assemblies may vary from a minimum of 1 to as many as desired. In addition, in the illustrative embodiment, each button assembly may be displaced by 0.5 mL, but in other embodiments the volume of displacement per button may vary. In addition, the storage section may have a larger or smaller capacity than described in the illustrative embodiment in various embodiments.

[0224] According to the above configuration, at least in part, button assemblies (e.g., button assemblies 1014, 1016, 108) may be used to control the filling capacity of the storage unit 908. The maximum filling capacity of the storage unit 908 may be achieved by not pressing any of the button assemblies. A second maximum filling capacity may be achieved by pressing one button assembly (e.g., button assembly 1014). A third maximum filling capacity may be achieved by pressing two button assemblies (e.g., button assemblies 1014, 1016). A minimum filling capacity may be achieved by pressing all three button assemblies (e.g., button assemblies 1014, 1016, 1018).

[0225] Furthermore, in the embodiment, the button assemblies 1014, 1016, and 1018 may be used, at least partially, to facilitate the filling of the reservoir 908. For example, once the filling needle (which may be fluid-connected to, for example, a vial of injectable fluid) is inserted into the reservoir 908, the button assemblies 1014, 1016, and 1018 may be pressed to deliver at least a portion of the air that may be contained in the reservoir into the vial of injectable fluid. The button assemblies 1014, 1016, and 1018 may then be released to allow the injectable fluid to flow from the vial into the reservoir 908. Once the reservoir 908 is filled with injectable fluid, one or more button assemblies (one or more of button assemblies 1014, 1016, and 1018) may be pressed, thereby pushing out at least a portion of the injectable fluid from the reservoir 908 (for example, via a needle used to fill the reservoir 908 and return it to the vial of injectable fluid). As discussed above, the volume of injectable fluid contained in the reservoir 908 may be controlled, for example, depending on how many button assemblies are pressed (for example, how much injectable fluid is pushed back into the vial of injectable fluid).

[0226] Specifically referring to Figures 62-64, the filling assist 1010 may be rotatably connected to the filling adapter substrate 1020. For example, the filling assist 1010 may include swivel members 1022, 1024 which may be configured to be received within swivel support members 1026, 1028, thereby allowing the filling assist to swivel between an open position (e.g., as shown in Figures 57-61) and a closed position (e.g., as shown in Figures 63-64). The closed position may be suitable for, for example, packaging the filling adapter 1000 or storing the filling adapter 1000. To ensure that the filling assist 1010 is properly oriented for filling the storage section 908, the filling adapter 1000 may include a support member 1030. To properly orient the filling assist 1010, the user may swivel the filling assist 1010 to a fully open position where the filling assist 1010 may contact the support member 1030.

[0227] According to an alternative embodiment, also with reference to Figure 65, the filling adapter 1050 may be configured to releasably engage with the disposable housing assembly 804 via a plurality of locking tabs (e.g., locking tabs 1052, 1054). In addition, the filling adapter 1050 may include a plurality of button assemblies (e.g., button assemblies 1056, 1058, 1060) that can interact with ribs 964, 966, 968 of the disposable housing assembly 804 to adjust the filling capacity of the reservoir 908. The filling adapter 1050 may further include a filling aid 1062 having a guide passage 1064 configured to align a syringe needle with the wall of the disposable housing 804 in order to access the reservoir 908 for the purpose of filling the reservoir 908 with an injectable fluid. The filling aid 1062 may be connected to the substrate 1066 as an integral component thereof, for example, by adhesive, heat fusion, compression fitting, etc.

[0228] See also Figures 66-74, the vial filling adapter 1100 may be configured to facilitate filling the reservoir 908 of the disposable housing assembly 804 directly from the vial. Similar to the filling adapter 1000, the vial filling adapter 1100 may include locking tabs 1102, 1104, 1106, and 1108, which may be configured to engage with the radial tabs 934, 936, 938, and 940 of the disposable housing assembly, substantially the same as the tabs 942, 944, 946, and 948 of the locking ring assembly 806. Therefore, the vial filling adapter 1100 may be releasably engaged with the disposable housing assembly 804 by rotating the vial filling adapter 1100 and the disposable housing assembly 804 relative to each other so that the vial filling adapter 1100 is aligned with the disposable housing assembly 804 and the locking tabs 1102, 1104, 1106, and 1108 are releasably engaged with the radial tabs 934, 936, 938, and 940.

[0229] As discussed above, the disposable housing assembly 804 may be configured to facilitate control of the amount of injectable fluid delivered to the reservoir 908 during filling. For example, the membrane assembly 902 of the disposable housing assembly 804 may include ribs 964, 966, 968 which may be pressed and displaced at least partially into the reservoir 908, thereby reducing the volume of the reservoir 908. Thus, when an injectable fluid is delivered to the reservoir 908, the volume of fluid that may be contained by the reservoir 908 may be reduced accordingly. The ribs 964, 966, 968 may be accessible through openings 958, 960, 962 in the uppermost portion 904 of the disposable housing assembly 804.

[0230] The vial filling adapter 1100 may include one or more button assemblies (e.g., button assemblies 1110, 1112, 1114) corresponding to the ribs 964, 966, 968 (e.g., shown in Figure 52A). That is, when the vial filling adapter 1100 is releasably engaged with the disposable housing assembly 804, the buttons 1110, 1112, 1114 may be aligned with the ribs 964, 966, 968. The button assemblies 1110, 1112, 1114 may be, for example, cantilever members that can be pressed. When the vial filling adapter 1100 is releasably engaged with the disposable housing assembly 804, one or more of the button assemblies 1110, 1112, 1114 may be pressed, in which case one of each of the ribs 964, 966, 968 may be displaced into the storage section 908, thereby reducing the volume of the storage section 908.

[0231] For example, for illustrative purposes, assume that the reservoir 908 has a maximum capacity of 3.00 mL. Furthermore, assume that the button assembly 1110 is configured to displace the rib 964 into the disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Furthermore, assume that the button assembly 1112 is configured to displace the rib 966 into the disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Furthermore, assume that the button assembly 1114 is configured to displace the rib 968 into the disposable housing assembly 804, resulting in a 0.50 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Therefore, if the user wishes to fill the reservoir 908 in the disposable housing assembly 804 with 2.00 mL of injectable fluid, the user may press the button assemblies 1112 and 1114 (resulting in the displacement of the ribs 966 and 968 into the disposable housing assembly 804) to effectively reduce the 3.00 mL capacity of the reservoir 908 in the disposable housing assembly 804 to 2.0 mL.

[0232] The vial filling adapter 1100 may further include a vial filling auxiliary assembly 1116 which can be configured to fluidly connect a vial of injectable fluid to a reservoir 908 of a disposable housing assembly 804 via a partition. Referring specifically to Figure 71, the vial filling auxiliary assembly may include a double-ended needle assembly 1118. The double-ended needle assembly 1118 includes a first needle end 1120 configured to penetrate a partition of a vial (not shown) and a second needle end 1122 configured to penetrate a partition of a disposable housing assembly 804. In such a case, the vial and reservoir 908 may be fluidly connected, allowing the injectable fluid to be transferred from the vial to the reservoir 908. The double-ended needle assembly 1118 may include a vial engaging portion 1124 adjacent to the first end 1120. The vial engaging portion arms 1124, 1126 may be configured, for example, to releasably engage with the vial cap to help maintain a fluid connection between the double-ended needle assembly 1118 and the vial. In addition, the double-ended needle assembly 1118 may include a body 1128 that can be slidably received in the opening 1130 of the vial filling assist body 1132. The vial filling assist body 1132 may include stabilizer arms 1134, 1136 that can be configured, for example, to stabilize the vial during filling of the disposable housing assembly 804. In one embodiment, the vial may be engaged with the double-ended needle assembly 1118 such that, for example, the first end 1120 penetrates the vial partition and the vial cap can be engaged by the engaging arms 1124, 1126. The body 1128 may be slidably inserted into the opening 1130 such that the second end 1122 of the double-ended needle assembly 1118 can penetrate the partition of the disposable housing assembly 804.

[0233] Similar to the filling adapter 1000, the vial filling assist assembly 1116 may be configured to be swivelably connected to the vial filling adapter substrate 1138. For example, the vial filling assist 1116 may include swivel members 1140, 1142 which may be configured to be received in swivel support members 1144, 1146 (for example, shown in Figure 71), thereby allowing the vial filling assist 1116 to swivel between an open position (for example, as shown in Figures 66-70) and a closed position (for example, as shown in Figures 72-74). The closed position may be suitable for, for example, packaging the vial filling adapter 1100 or storing the vial filling adapter 1100. To ensure that the filling assist 1116 is properly oriented for filling the storage section 908, the vial filling adapter 1100 may include a support member 1148. To properly orient the filling assist 1116, the user may pivot the filling assist 1116 to a fully open position where the filling assist 1116 may contact the support member 1148. In addition, the vial filling adapter substrate 1138 may include one or more locking features (e.g., locking tabs 1150, 1152) that may engage with the vial filling assist 1116 and maintain the vial filling assist 1116 in a closed position. The vial filling adapter substrate 1138 may also include features (e.g., tabs 1154, 1156) that may be configured to assist in holding the double-ended needle assembly 1118 by preventing its sliding separation from the vial filling assist body 1132.

[0234] As shown in Figures 72-74, the filling assist assembly 1116 is in the closed position. In this configuration, the support member 1148 may also function as a needle guard. When removing the filling assist assembly 1116 from the disposable housing assembly 804, the support member 1148 may function to allow the user to firmly grasp the end and rotate the filling assist assembly 1116 for removal. As shown in Figure 70, in the open position, the support member 1148 may function as a stopper to maintain proper orientation.

[0235] Referring again to Figures 57–73, an illustrative embodiment of the filling adapter includes a gripping feature (e.g., 1166 in Figure 72). The gripping feature 1166 may provide a gripping interface for removing the filling adapter from the disposable housing assembly 804. Although shown in these figures in one configuration, the configuration may vary in other embodiments. In yet another embodiment, the gripping feature may not be included.

[0236] According to one embodiment, the filling adapter substrate 1020 and the vial filling adapter substrate 1138 may be interchangeable components. Therefore, a single substrate (for example, either the filling adapter substrate 1020 or the vial filling adapter substrate 1138) may be used together with the filling aid 1010 or the vial filling aid 1116. Thus, the number of individual components required for both filling adapters may be reduced, and the user may have the ability to select the filling adapter that is best suited to a given filling scenario.

[0237] The various components of the filling adapter may provide many safety benefits, including, but not limited to, providing a system for filling the reservoir without handling a needle, protecting the reservoir from unintended contact with a needle, i.e., destruction of the reservoir's integrity through unintended puncture, and being designed for two-handed use; and in some cases, providing a system for maintaining air in the reservoir.

[0238] As discussed above, the reusable housing assembly 802 may include, for example, a rechargeable battery 832. See also Figures 75-80, the battery charger 1200 may be configured to recharge the battery 832. The battery charger 1200 may include the housing 1202 having a top plate 1204. The top plate 1204 may generally include one or more electrical contacts 1206 which may be electrically coupled to electrical contacts 834 of the reusable housing assembly 802. The electrical contacts 1206 may include, but are not limited to, electrical contact pads, spring-biased electrical contact members, etc. In addition, the top plate 1204 may include alignment tabs 1208, 1210 which may be configured to mesh with openings 836, 838 of the substrate 818 of the reusable housing assembly 802 (as shown, for example, in Figure 35C). The cooperation of the alignment tabs 1208, 1210 and the openings 836, 838 may ensure that the reusable housing assembly 802 is aligned with the battery charger 1200 so that the electrical contacts 1206 of the battery charger 1200 may be electrically coupled with the electrical contacts 834 of the reusable housing assembly 802.

[0239] See also Figures 77 and 78, the battery charger 1200 may be configured to releasably engage with a reusable housing assembly 802. For example, similar to a disposable housing assembly 804, the battery charger 1200 may include one or more locking tabs (e.g., locking tabs 1212, 1214 shown in Figure 76). The locking tabs (e.g., locking tabs 1212, 1214) may be engaged by tabs 942, 944, 946, 948 of a locking ring assembly 806. In such a case, the reusable housing assembly 802 may be aligned with the battery charger 1200 (via alignment tabs 1208, 1210) with the locking ring 806 in a first released position, as shown in Figure 77. The locking ring 806 may be rotated relative to the battery charger 1200 in the direction of arrow 1216, as shown in Figure 78, so that the tabs 942, 944, 946, and 948 of the locking ring 806 are releasably engaged with the locking tabs of the battery charger 1200 (e.g., locking tabs 1212 and 1214).

[0240] In some embodiments, the battery charger 1200 may include a recessed area 1218, which, for example in an illustrative embodiment, may provide a gap to accommodate the pump and valve components of the reusable housing assembly 802. Referring also to Figures 79 and 80, the battery charger 1200 may supply current to the electrical contact 1206 (and thereby to the reusable housing assembly 802 via the electrical contact 834) to recharge the battery 832 of the reusable housing assembly 802. In some embodiments, current may not be supplied to the electrical contact 1206 when no signal indicating a fully engaged reusable housing is provided. According to such embodiments, the risk associated with an electrical short circuit (e.g., due to foreign matter in contact with the electrical contact 1206) and damage to the reusable housing assembly 802 (e.g., due to improper initial alignment between the electrical contact 1206 and the electrical contact 834) may be reduced. In addition, the battery charger 1200 may not unnecessarily draw current when the battery charger is not charging the reusable housing assembly 802.

[0241] Still referring to Figures 79 and 80, the battery charger 1200 may include a lower housing 1224 and a top plate 1204. The printed circuit board 1222 (which may include, for example, electrical contacts 1206) may be located in a cavity between the top plate 1204 and the lower housing 1224.

[0242] See also Figures 81-89, which illustrate various embodiments of the battery charger / docking station. Figures 81 and 82 depict a desktop charger 1250 including a recess 1252 configured to mesh with and recharge a reusable housing assembly (e.g., reusable housing assembly 802). The reusable housing assembly may rest in the recess 1252 or may be releasably engaged into the recess 1252, as discussed above. In addition, the desktop charger 1250 may include a recess 1254 configured to mesh with a remote control assembly (e.g., remote control assembly 300). The recess 1254 may include a USB plug 1256, which may be configured to connect with the remote control assembly when the remote control assembly is placed in the recess 1254, for example. The USB plug 1256 may enable round-trip data transfer to and from the remote control, as well as charging of the remote control assembly. The desktop charger 1250 may also include a USB port 1258 (which may include, for example, a mini USB port) to enable the desktop charger to receive power (for example, to charge a reusable housing assembly and / or a remote control assembly). In addition / alternatively, the USB port 1258 may be configured for data transfer to and from the remote control assembly and / or the reusable housing assembly, for example, by connection to a computer (not shown).

[0243] Referring to Figures 83A-83B, as in previous embodiments, the desktop charger 1260 may include a recess 1262 for engaging with a reusable housing assembly (e.g., reusable housing assembly 1264). The desktop charger may also include a recess 1266 configured to receive a remote control assembly (e.g., remote control assembly 1268). One or more of the recesses 1262, 1266 may each include electrical and / or data connections configured to charge the reusable housing assembly 1262 and / or the remote control assembly 1268, and / or transfer data to and from there.

[0244] Referring to Figures 84A-84B, another embodiment of the desktop charger is shown. Similar to desktop charger 1260, desktop charger 1270 may include recesses (not shown) for engaging with reusable housing assembly 1272 and remote control assembly 1274, respectively. As shown, desktop charger 1270 may hold reusable housing assembly 1272 and remote control assembly 1274 in a parallel configuration. Desktop charger 1270 may include various electrical and data connections configured to charge the reusable housing assembly 1272 and / or remote control assembly 1274, and / or transfer data thereto and therefrom, as described in the various embodiments above.

[0245] Referring to Figures 85A-85D, the foldable charger 1280 may include a recess 1282 for receiving a reusable housing assembly 1284 and a remote control assembly 1286. The foldable charger 1280 may include various electrical and data connections configured to charge the reusable housing assembly 1284 and / or the remote control assembly 1286, and / or transfer data to and from there, as described in the various embodiments above. In addition, as shown in Figures 85B-85D, the foldable charger 1280 may include a swivelable cover 1288. The swivelable cover 1288 may be configured to swivel between an open position (e.g., as shown in Figure 85B) in which the reusable housing assembly 1284 and the remote control assembly 1286 may be docked to the foldable charger 1280, and a closed position (e.g., as shown in Figure 85D) in which the recess 1282 may be covered by the swivelable cover 1288. In the closed position, the recess 1282, and any electrical and / or data connections located therein, may be protected from damage.

[0246] Referring to Figure 86, the wall charger 1290 may include a recess 1292 configured to receive a reusable housing assembly 1294. In addition, the wall charger 1290 may include a recess 1296 configured to receive a remote control assembly 1298. The reusable housing assembly 1294 and the remote control assembly 1298 may be positioned, for example, in a stacked configuration, thereby providing a relatively thin profile. The rear portion of the wall charger 1290 may include an electrical plug configured to allow the wall charger to be plugged into an electrical receptacle. In such a configuration, the wall charger 1290 may achieve a wall-mounted configuration while plugged into the electrical receptacle. In addition, while plugged into the electrical receptacle, the wall charger 1290 may be provided with power to charge the reusable housing assembly 1294 and / or the remote control assembly 1298.

[0247] Referring to Figure 87, the wall charger 1300 may include a recess 1302 configured to receive a remote control assembly 1304. In addition, the wall charger may include a recess (not shown) configured to receive a reusable housing assembly 1306. The wall charger 1300 may be configured to position the remote control assembly 1304 and the reusable housing assembly 1306 in an antiparallel configuration, which may provide a relatively thin profile. In addition, the wall charger 1300 may include an electrical plug 1308 configured to be plugged into an electrical receptacle. The electrical plug 1308 may include a retractable configuration, which allows the electrical plug 1308 to pivot between a deployed position (e.g., as shown) and a retracted position. In the deployed position, the electrical plug 1308 may be oriented to be plugged into an electrical receptacle. In the storage position, the electrical plug 1308 may be placed in a recess 1310, which may protect the electrical plug 1308 from damage and / or damage to other items.

[0248] Referring to Figure 88, the charger 1320 may include a recess 1322 configured to receive a reusable housing assembly 1324. The charger 1320 may also include a recess (not shown) configured to receive a remote control assembly 1326. The charger 1320 may also include a cover 1328. The cover 1328 may be configured to pivot between an open position (as shown) and a closed position. When the cover 1328 is in the open position, the reusable housing assembly 1324 and the remote control assembly 1326 may be accessible (for example, allowing a user to remove / install the reusable housing assembly 1324 and / or remote control assembly 1326 from / into the charger 1320). When cover 1324 is in the closed position, cover 1328 and charger body 1330 may substantially enclose the reusable housing assembly 1324 and / or remote control assembly 1326 and / or recess 1322, the recess being configured to receive the remote control assembly 1326, thereby providing damage and / or tamper protection against any electrical and / or data connections associated with the reusable housing assembly 1324, the remote control assembly 1326 and / or charger 1320.

[0249] Referring to Figures 89A-89B, the wall charger 1350 may include a recess 1352 configured to receive a remote control assembly 1354. The wall charger 1350 may also include a recess 1356 configured to receive a reusable housing assembly 1358. The wall charger 1350 may be configured to position the remote control assembly 1354 and the reusable housing assembly 1358 in a substantially parallel configuration, thereby providing a relatively thin profile. The charger 1350 may also include an electrical plug 1360, which may be configured to be plugged into an electrical receptacle, for example. The electrical plug 1360 may include a retractable configuration, in which the electrical plug 1360 may be rotatable between a deployed position (e.g., as shown) and a retracted position. In the deployed position, the electrical plug 1360 may be oriented to be plugged into an electrical receptacle. In the storage position, the electrical plug 1360 may be placed in a recess 1362, which may protect the electrical plug 1308 from damage and / or damage to other items.

[0250] Infusion pump therapy may include volume and time specifications. The amount of fluid dispensed, along with the dispensing timing, may be two important factors of infusion pump therapy. As will be discussed in detail below, the infusion pump devices and systems described herein may provide a method of dispensing fluid, along with devices, systems, and methods for measuring the amount of fluid dispensed. However, in situations where the calibration and accuracy of the measuring device are critical, there may be an advantage in determining the degradation of the measuring device's accuracy as quickly as possible. Thus, there is an advantage to off-board verification of volume and dispensing.

[0251] As discussed above, the injection pump assembly 100 may include a volume sensor assembly 148 configured to monitor the amount of fluid injected by the injection pump assembly 100. Furthermore, as discussed above, the injection pump assembly 100 may be configured such that the volume measurement produced by the volume sensor assembly 148 is used through a feedback loop to control the amount of injectable fluid injected to the user.

[0252] See also Figures 90A-90C, which show one line drawing and two cross-sectional views of the capacitive sensor assembly 148. See also Figures 91A-91I, which show various isometric and line drawings of the capacitive sensor assembly 148 (shown to include the upper housing 1400). See also Figures 92A-92I, which show various isometric and line drawings of the capacitive sensor assembly 148 (with the upper housing 1400 removed), exposing the speaker assembly 622, the reference microphone 626, and the printed circuit board assembly 830. See also Figures 93A-93I, which show various isometric and line drawings of the capacitive sensor assembly 148 (with the printed circuit board assembly 830 removed), exposing the port assembly 624. See also Figures 94A-94F, which show various isometric and line drawings of the capacitive sensor assembly 148 (with the printed circuit board assembly 830 removed), exposing the port assembly 624. See also Figure 95, which shows an exploded view of the capacitive sensor assembly 148, exposing the upper housing 1400, speaker assembly 622, reference microphone 626, seal assembly 1404, lower housing 1402, port assembly 624, spring diaphragm 628, and retaining ring assembly 1406.

[0253] The following discussion concerns the design and operation of the capacitive sensor assembly 148 (shown in a simplified form in Figure 96). The following terms may be used in the following discussion.

[0254] [Table 10-1]

[0255] [Table 10-2] (Derivation of the formula for capacitive sensor assembly 148:) (Modeling of acoustic capacity) The pressure and volume of an ideal adiabatic gas can be related by the following:

[0256]

number

[0257]

number

[0258]

number

[0259]

number

[0260]

number

[0261]

number

[0262]

number

[0263]

number

[0264] By applying the law of ideal gases P=ρRT and substituting it for pressure, the following equation can be obtained.

[0265]

number

[0266] [ka] It can be described by.

[0267]

number

[0268]

number

[0269] Expression format

[0270] [ka] Assuming laminar friction, the frictional force acting on the mass of fluid in the channel can be described as follows:

[0271]

number

[0272]

number

[0273]

number

[0274]

number

[0275]

number

[0276] [ka] When treated as input to be replaced, one expression may be deleted.

[0277]

number

[0278]

number

[0279]

number

[0280] See also Figure 97, which shows the Bode plot of Equation 23.

[0281] The difficulty with this relationship is that the complex poles depend on the variable capacitance V2 and the reference capacitance V1. Changes in the average speaker position can lead to errors in estimated capacitance.

[0282] (Port-to-port transfer function) The relationship between the two capacitances on either side of an acoustic port can be called the inter-port transfer function. This relationship is as follows:

[0283]

number

[0284] This relationship has the advantage that the poles depend only on the variable capacitance and not on the reference capacitance. However, there is a drawback in that the resonance peak is actually due to a zero inversion in response to the reference capacitance pressure. Therefore, the pressure measurement in the reference chamber has a low amplitude near the resonance, potentially increasing the noise of the measurement.

[0285] (Transfer function between speakers) Pressure can also be measured from both sides of the speaker. This is called the speaker-to-speaker transfer function.

[0286]

number

[0287] This transfer function has a set of complex poles in addition to a set of complex zeros.

[0288] Considering the limit of this transfer function,

[0289] [ka] , and

[0290] [ka] That is the case.

[0291] (Resonance Q coefficient and peak response) The quality of resonance is the ratio of stored energy to the power loss increased by the resonant frequency. For a purely secondary system, the quality factor can be expressed as a function of the damping ratio.

[0292]

number

[0293]

number

[0294]

number

[0295]

number

[0296] [ka] That is the case.

[0297] The resonant frequency can be determined in a physical system using several methods. A phase-locked loop may be employed to find the point of 90° phase, where this frequency may correspond to the system's natural frequency. Alternatively, the resonant frequency may be calculated using the phases at any two frequencies.

[0298] The phase φ at any given frequency satisfies the following relationship:

[0299]

number

[0300] [ka] That is the case.

[0301] When we find the solution to V2, we obtain the following equation.

[0302]

number

[0303]

number

[0304] Rewriting equation 33 with respect to variable capacity yields the following equation.

[0305]

number

[0306] The transfer function of a system can be expressed as a rational function of s. In the general case, a transfer function with an n-th order numerator and an m-th order denominator is expressed as follows: N and D are the coefficients of the numerator and denominator, respectively. The equation is normalized so that the principal coefficient of the denominator is 1.

[0307]

number

[0308]

number

[0309] This equation can be rewritten as follows:

[0310]

number

[0311]

number

[0312]

number

[0313]

number

[0314]

number

[0315]

number

[0316]

number

[0317]

number

[0318]

number

[0319]

number

[0320] The coefficients of this transfer function can be determined based on the equation obtained in the previous section.

[0321]

number

[0322]

number

[0323] To simplify the algorithm, some of the terms can be combined.

[0324]

number

[0325]

number

[0326] To derive an equation for D given the complex response vector G and the natural frequency s=jω, X is its real part and imaginary part

[0327]

number

[0328] Next, the real and imaginary parts of expression D can be as follows:

[0329]

number

[0330]

number

[0331]

number

[0332]

number

[0333]

number

[0334]

number

[0335]

number

[0336] Next, the determinant of the adjoint matrix can be calculated using the zero element in the original array.

[0337]

number

[0338]

number

[0339]

number

[0340]

number

[0341] The final step is to obtain a quantitative assessment of how well the data fits the model. Therefore, the original formula for the error is as follows:

[0342]

number

[0343]

number

[0344]

number

[0345] Model fit errors can also be used to detect sensor failures.

[0346] (Alternative solutions for secondary systems)

[0347]

number

[0348]

number

[0349]

number

[0350]

number

[0351]

number

[0352] The coefficients of this transfer function can be determined as follows, based on the equation obtained in the previous section.

[0353]

number

[0354]

number

[0355] To simplify the algorithm, several terms may be combined.

[0356]

number

[0357]

number

[0358] To derive the equation for D using the complex response vector G and the natural frequency s=jω, the divided X can be separated into its real and imaginary parts as follows.

[0359]

number

[0360]

number

[0361]

number

[0362]

number

[0363]

number

[0364]

number

[0365] In addition, the total signal variance can be calculated and compared to the variance of a pure tone extracted using the Discrete Fourier Transform (i.e., DFT). This can provide a measure of how much of the signal power originates from noise sources or distortion. This value may then be used to reject and repeat poor measurements.

[0366] (Calculation of Discrete Fourier Transform) The signal from the microphone can be sampled in sync with the output to the speaker assembly 622, such that a fixed number of points N are taken for each wavelength. The measured signal at each point of the wavelength is summed over an integer number of wavelengths M and can be stored by the ISR in array x for processing after all data for that frequency has been collected.

[0367] DFT can be performed on data at integer values ​​corresponding to the speaker's driving frequency. The general formula for the first harmonic of the DFT is as follows:

[0368]

number

[0369]

number

[0370]

number

[0371]

number

[0372]

number

[0373] This can be expressed as follows:

[0374]

number

[0375]

number

[0376] (Calculation of signal dispersion) The pseudo-dispersion of the signal can be calculated using the following relationship.

[0377]

Number

[0378] The sum can be approximately for a 12-bit ADC

[0379]

Chemistry

[0380]

Chemistry

[0381] (Calculation of relative microphone response) The relative response (G) of microphones 626 and 630 can be calculated from the complex response of each microphone as follows:

[0382]

number

[0383]

number

[0384] [ka] This could be a phase offset between the two microphones 626 and 630. To compensate for this phase offset, complex rotation may be applied to the relative frequency response calculated in the previous section.

[0385]

number

[0386] The following simultaneous equations may represent a 3-chamber configuration.

[0387]

number

[0388]

number

[0389]

number

[0390]

number

[0391]

number

[0392]

Number

[0393]

Number

[0394] The time delay can be expressed in the Laplace domain as follows.

[0395]

Number

[0396]

Number

[0397] (Three-chamber capacitance estimation) The capacitance sensor assembly 148 may also be configured using a third reference capacitance (e.g., reference capacitance 1508, Figure 103) connected to a separate resonant port (e.g., port 1510, Figure 103). This configuration may enable temperature-independent capacitance estimation.

[0398] The simultaneous equations representing the 3-chamber configuration may also be as follows:

[0399]

number

[0400]

number

[0401]

number

[0402]

number

[0403]

number

[0404] The capacitance of the capacitance sensor chamber 620 can be estimated using the ratio of the natural frequencies of the two resonant ports, as follows:

[0405]

number

[0406] (Exponential capacity model) Assume that the outflow through the flow resistance is expressed in the following form:

[0407]

number

[0408]

number

[0409]

number

[0410]

number

[0411]

number

[0412]

number

[0413]

number

[0414]

number

[0415] [ka] That is the case.

[0416] (Implementation details) (End effect) Air resonating within a port (e.g., port assembly 624) may extend into the acoustic capacitance at the end of each vibration. The distance the air extends can be estimated based on the basic capacitance sensor assembly equations. For any given acoustic capacitance, the distance the air extends into the capacitance can be expressed as a function of pressure and port cross-sectional area as follows:

[0417]

number

[0418]

number

[0419] (Sizing V1 (i.e., fixed capacitance) relative to V2 (i.e., variable capacitance)) Sizing V1 (e.g., fixed capacitance 1500) may require a trade-off of acoustic capacitance with respect to the relative position of the poles and zero in the transfer function. The transfer functions of both V1 and V2 (e.g., variable capacitance 1502) are shown below for the capacitance displacement of speaker assembly 622.

[0420]

number

[0421]

number

[0422] As V1 is increased, the gain may decrease, and the speaker may be driven with a larger amplitude to obtain the same sound pressure level. However, increasing V1 may also have the benefit of shifting the complex zeros in the p1 transfer function toward the complex poles. In the limited case where V1→∞ and α→1, there is pole zero cancellation and a flat response. Thus, increasing V1 reduces both resonance and notch in the p1 transfer function, and ω n There is a benefit in moving the p2 pole toward the direction of the transfer function, which results in lower sensitivity to measurement errors when calculating the p2 / p1 transfer function.

[0423] Figure 104 is a graph representation of the following equation.

[0424]

number

[0425]

number

[0426]

number

[0427] The demodulation routine can effectively remove noise except for specific frequencies of the demodulation. If the sample frequency is dynamically set to a fixed multiple of the demodulation frequency, the frequencies of the noise that can be aliased down to the demodulation frequency may be a fixed set of harmonics of its fundamental frequency.

[0428] For example, if the sampling frequency is 8 times the demodulation frequency, the noise frequencies that can be aliased down to that frequency are as follows:

[0429]

number

[0430] [ka] Therefore, for β=16, the following series arises.

[0431]

number

[0432]

number

[0433]

number

[0434] However, measurements can sometimes be more susceptible to noise in temperature measurements. Temperature changes during differential sinusoidal sweeps can introduce errors that appear more like offsets than gain changes.

[0435]

number

[0436] The LM73 temperature sensor has a published accuracy of + / -1°C and a resolution of 0.03°C. Furthermore, the LM73 temperature sensor appears to consistently have an initial transient of approximately 0.3°C, requiring about five sinusoidal sweeps to become horizontal (as shown in Figure 108).

[0437] Since the above injection pump assemblies (e.g., injection pump assemblies 100, 100', 400, 500) provide discrete delivery of the injectable fluid, the above injection pump assemblies may also be modeled in a completely discrete region (as shown in Figure 32), which can be summarized by the following equation.

[0438]

number

[0439]

number

[0440] The following terms may be used for the following discussions.

[0441] [Table 11] As part of the demodulation routine employed in each frequency response calculation, minimum and maximum measurements for both the fixed-capacitance microphone 626 and the variable-capacitance microphone 630 can be calculated. The sum of these maximum and minimum values ​​can be calculated for both microphones 626 and 630 over the entire sinusoidal sweep (as discussed above), as follows:

[0442]

number

[0443]

number

[0444]

number

[0445] Thresholding for the above algorithm can be based entirely on numerical evidence. For example, a typical minimum / maximum response difference test may show that no individual difference is less than 500 ADC counts. Therefore, all data tested while the disposable housing assembly 114 is being detached from the reusable housing assembly 102 can be considered well below 500 ADC counts, thus showing all minimum / maximum response differences. Thus, the threshold for δ may be set to T=500.

[0446] Although the volume sensor assembly 148 is described above as being used within an injection pump assembly (e.g., injection pump assembly 100), other configurations are possible and are considered to be within the scope of this disclosure, so this is for illustrative purposes only and is not intended to limit this disclosure. For example, the volume sensor assembly 148 may be used in a process control environment, for example, to control the volume of chemicals mixed together. Alternatively, the volume sensor assembly 148 may be used in a beverage dispensing system, for example, to control the volume of raw materials mixed together.

[0447] Although the capacitance sensor assembly 148 is described above as utilizing a port (e.g., port assembly 624) as a resonator, this is for illustrative purposes only, as other configurations are possible and are considered to be within the scope of this disclosure. For example, a solid mass (not shown) may be suspended within the port assembly 624 and function as a resonator for the capacitance sensor assembly 148. Specifically, the resonator mass (not shown) may be suspended over a diaphragm (not shown) spanning the port assembly 624. Alternatively, the diaphragm itself (not shown) may serve as the resonator mass. The natural frequency of the capacitance sensor assembly 148 may be a function of the capacitance of the variable capacitor 1502. Therefore, if the natural frequency of the capacitance sensor assembly 148 can be measured, the capacitance of the variable capacitor 1502 can be calculated.

[0448] The natural frequency of the capacitance sensor assembly 148 may be measured in a number of different ways. For example, a time-varying force may be applied to a diaphragm (not shown), and the relationship between the force and the motion of the diaphragm (not shown) may be used to estimate the natural frequency of the capacitive sensor assembly 148. Alternatively, a mass (not shown) may be perturbed and then vibrated. The unforced motion of the mass (not shown) may then be used to calculate the natural frequency of the capacitive sensor assembly 148.

[0449] The force applied to the resonant mass (not shown) may be achieved in various ways, including, but not limited to, the following: The speaker assembly 622 may generate time-varying pressure within a fixed capacitance of 1500. The resonant mass (not shown) may be a piezoelectric material that responds to time-varying voltage / current. The resonant mass (not shown) may be an audio coil that responds to time-varying voltage / current.

[0450] The force applied to the resonant mass may be measured by various methods, including, but not limited to, the following: • Measure the pressure in a fixed volume. The resonant mass (not shown) may be a piezoelectric material. The strain gauge may be connected to a diaphragm (not shown) or other structural member supporting a resonant mass (not shown).

[0451] Similarly, the displacement of the resonant mass (not shown) may be measured by measuring the pressure in a variable capacitance, or by measuring it directly in various ways, including, but not limited to, the following: • Via piezoelectric sensor. • Via a capacity sensor. • Via optical sensors. • Via a Hall effect sensor. • It uses a potentiometer (time-varying impedance) sensor. • Via inductive sensors. • It is transmitted via a linear variable differential transformer (LVDT).

[0452] Furthermore, the resonant mass (not shown) may be integrated with either a force-type sensor or a displacement-type sensor (i.e., the resonant mass (not shown) may be made of a piezoelectric material).

[0453] The application of force and measurement of displacement may be achieved by a single device. For example, a piezoelectric material may be used as the resonant mass (not shown), and a time-varying voltage / current may be applied to the piezoelectric material to generate a time-varying force. The resulting voltage / current applied to the piezoelectric material may be measured, and the transfer function between the two may be used to estimate the natural frequency of the capacitive sensor assembly 148.

[0454] As discussed above, the resonant frequency of the capacitance sensor assembly 148 may be estimated using swept sinusoidal system identification. Specifically, the above model fitting may allow the resonant frequency of the port assembly to be extracted from sinusoidal sweep data, which may then be used to determine the delivery capacitance. An ideal relationship between the resonant frequency and the delivery capacitance may be expressed as follows:

[0455]

number

[0456]

number

[0457]

number

[0458] [ka] That is the case.

[0459] Next, the injection pump assembly 100 may compare this calculated capacity V2 (i.e., representing the actual volume of injectable fluid delivered to the user) with the target capacity (i.e., representing the amount of fluid that should have been delivered to the user). For example, suppose the injection pump assembly 100 delivered a base dose of 0.100 units of injectable fluid to the user every 30 minutes. Furthermore, suppose that upon achieving such delivery, the capacity sensor assembly 148 indicates a calculated capacity V2 of 0.095 units of injectable fluid (i.e., representing the actual volume of injectable fluid delivered to the user).

[0460] When calculating the capacity V2, the injection pump assembly 100 may first determine the volume of fluid in the capacity sensor chamber 620 before dispensing a dose of the injectable fluid, and later determine the volume of fluid in the capacity sensor chamber 620 after dispensing a dose of the injectable fluid. The difference between these two measurements represents the capacity V2 (i.e., the actual volume of injectable fluid delivered to the user). Thus, V2 is a differential measurement.

[0461] V2 may be the total void space on the diaphragm within the variable volume chamber. Actual fluid delivery to the patient may be the difference in V2 from when the chamber was full until the measuring valve was opened and the chamber was emptied. V2 does not necessarily have to be the delivery volume. For example, the air volume may be measured, and a series of differential measurements may be taken. For occlusion, an empty measurement may be taken, the chamber may be filled, a complete measurement may be taken, and then a final measurement may be taken after the outlet valve is opened. Thus, the difference between the first measurement and the second measurement may be the amount delivered, and the difference between the second measurement and the third measurement may be the amount delivered to the patient.

[0462] Therefore, the electrical control assembly 110 may determine that the delivered injectable fluid is 0.005 units less than required. In accordance with this determination, the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that any additional required dose may be dispensed. Alternatively, the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that the additional dose may be dispensed along with the next dose. Thus, during the dispensing of the next 0.100 unit dose of injectable fluid, the output command to the pump may be modified based on the difference between the target and the delivered amount.

[0463] See also Figure 110, which illustrates one specific implementation of a control system for controlling the amount of injectable fluid currently being injected, based at least partially on the amount of injectable fluid previously administered. Specifically, continuing the above embodiment, for illustrative purposes, suppose that the electrical control assembly 110 requests the delivery of a 0.100 unit dose of injectable fluid to the user. Thus, the electrical control assembly 110 may provide the capacity controller 1602 with a target differential capacity signal 1600 (identifying a partial base capacity of 0.010 units of injectable fluid per cycle of the shape memory actuator 112). Thus, in this particular embodiment, the shape memory actuator 112 may need to be circulated 10 times to achieve the desired base capacity of 0.100 units of injectable fluid (i.e., 10 cycles × 0.010 units per cycle = 0.100 units). Next, the capacity controller 1602 may provide the SMA (i.e., shape memory actuator) controller 1608 with an "on-time" signal 1606. Additionally, the battery voltage signal 1610 is also provided to the SMA controller 1608.

[0464] Specifically, the shape memory actuator 112 may be controlled by changing the amount of thermal energy (e.g., joules) applied to the shape memory actuator 112. Therefore, if the voltage level of the battery 606 is reduced, the amount of joules applied to the shape memory actuator 112 may also be reduced over a specified period. Conversely, if the voltage level of the battery 606 is increased, the amount of joules applied to the shape memory actuator 112 may also be increased over a specified period. Therefore, by monitoring the voltage level of the battery 606 (via the battery voltage signal 1610), the type of signal applied to the shape memory actuator 112 may be changed to ensure that an appropriate amount of thermal energy is applied to the shape memory actuator 112 regardless of the battery voltage level.

[0465] The SMA controller 1608 may process the "on-time" signal 1606 and the battery voltage signal 1610 to determine the appropriate SMA drive signal 1612 to apply to the shape memory actuator 112. One embodiment of the SMA drive signal 1612 may be a series of binary pulses in which the amplitude of the SMA drive signal 1612 essentially controls the stroke length of the shape memory actuator 112 (and thus the pump assembly 106), and the load cycle of the SMA drive signal 1612 essentially controls the stroke rate of the shape memory actuator 112 (and thus the pump assembly 106). Furthermore, since the SMA drive signal 1612 represents differential capacitance (i.e., the capacitance injected during each cycle of the shape memory actuator 112), the SMA drive signal 1612 may be integrated by a discrete-time integrator 1614 to generate a capacitance signal 1616 that can indicate the total amount of injectable fluid injected during multiple cycles of the shape memory actuator 112. For example, since it may take 10 cycles of the shape memory actuator (0.010 units per cycle) to inject 0.100 units of injectable fluid (as discussed above), the discrete-time integrator 1614 may integrate the SMA drive signal 1612 over these 10 cycles to determine the total amount of injectable fluid injected (as represented by the capacitance signal 1616).

[0466] The SMA drive signal 1612 may, for example, activate the pump assembly 106 over one cycle, resulting in the filling of the capacity sensor chamber 620 contained within the capacity sensor assembly 148. The injection pump assembly 100 may then perform a first measurement of the volume of fluid contained within the capacity sensor chamber 620 (as discussed above). Furthermore, as discussed above, the measuring valve assembly 610 may be subsequently energized to deliver all or part of the fluid in the capacity sensor chamber 620 to the user. The injection pump assembly 100 may then perform a measurement of the volume of fluid contained within the capacity sensor chamber 620 (as described above) and use these two measurements to determine V2 (i.e., the actual volume of injectable fluid delivered to the user during the current cycle of the shape memory actuator 112). Once determined, V2 (i.e., as represented by signal 1618) may be provided (i.e., feedback) to the capacity controller 1602 for comparison with a previously received target differential capacity.

[0467] Continuing with the above embodiment where the differential target volume was 0.010 units of injectable fluid, assume that V2 (i.e., as represented by signal 1618) identifies 0.009 units of injectable fluid as delivered to the user. Thus, the injection pump assembly 100 may increase the next differential target volume to 0.011 units to compensate for the previous 0.001 unit deficit. Thus, as discussed above, the amplitude and / or load cycle of the SMA drive signal 1612 may be increased when delivering the next basic dose of injectable fluid to the user. This process may be repeated over the remaining 9 cycles of the shape memory actuator 112 (as discussed above), and the discrete-time integrator 1614 may integrate the SMA drive signal 1612 (to generate the volume signal 1616) which can determine the total amount of injectable fluid delivered to the user.

[0468] See also Figure 111, which shows one possible embodiment of the capacitance controller 1602. In this particular implementation, the capacitance controller 1602 may include a PI (proportional-integral) controller 1650. The capacitance controller 1602 may also include a forward feed controller 1652 for setting an initial "guess" regarding the "on-time" signal 1606. For example, in the situation described above where the target differential capacitance signal 1600 identifies a partial base capacitance of 0.010 units of fluid that can be injected per cycle of the shape memory actuator 112, the forward feed controller 1652 may define an initial "on-time" of, for example, 1 millisecond. The forward feed controller 1652 may include a reference table defining the initial "on-time," which is at least partially based on the target differential capacitance signal 1600. The capacitance controller 1602 may further include a discrete-time integrator 1654 for integrating the target differential capacitance signal 1600 and a discrete-time integrator 1656 for integrating V2 (i.e., as represented by the signal 1618).

[0469] See also Figure 112, which shows one possible embodiment of the forward feed controller 1652. In this particular implementation, the forward feed controller 1652 may define a constant value signal 1658 and may include an amplifier 1660 (e.g., a unified gain amplifier) ​​whose output may be summed with the constant value signal 1658 at an adder node 1662. The resulting sum signal (i.e., signal 1664) may be provided as an input signal to, for example, a reference table 1666, which may be processed to generate the output signal of the forward feed controller 1652.

[0470] As discussed above, the pump assembly 106 may be controlled by the shape memory actuator 112. Furthermore, as discussed above, the SMA controller 1608 may process the "on-time" signal 1606 and the battery voltage signal 1610 to determine the appropriate SMA drive signal 1612 to apply to the shape memory actuator 112.

[0471] See also Figures 113-114, which show one specific implementation of the SMA controller 1608. As discussed above, the SMA controller 1608 may respond to an "on-time" signal 1606 and a battery voltage signal 1610, and may provide an SMA drive signal 1612 to the shape memory actuator 112. The SMA controller 1608 may include a feedback loop (including a unit delay 1700), the output of which may be multiplied by the battery voltage signal 1610 in a multiplier 1702. The output of the multiplier 1702 may be amplified, for example, using a unified gain amplifier 1704. The output of the amplifier 1704 may be applied to the negative input of an adder node 1706 (to which the "on-time" signal 1606 is applied). The output of the adder node 1706 may be amplified, for example, via the unified gain amplifier 1708. The SMA controller may also include a forward feed controller 1710 to provide an initial value for the SMA drive signal 1612 (similar to the forward feed controller 1652 of the capacitive controller 1602, see Figure 112). The output of the forward feed controller 1710 may be summed with the output of amplifier 1708 and the integral representation of the output of amplifier 1708 (i.e., signal 1714) at the summing node 1712 to form the SMA drive signal 1612.

[0472] The SMA drive signal 1612 may be provided to a control circuit that achieves the application of power to the shape memory actuator 112. For example, the SMA drive signal 1612 may be applied to a switching assembly 1716 that can selectively apply a current signal 1718 (supplied from the battery 606) and / or a fixed signal 1720 to the shape memory actuator. For example, the SMA drive signal 1612 may achieve the application of energy (supplied from the battery 606 via the current signal 1718) via the switching assembly 1716 in a manner that achieves a load cycle defined by the SMA drive signal 1612. A unit delay 1722 may generate a delayed version of the signal applied to the shape memory actuator 112 to form a battery voltage signal 1610 (which may be applied to the SMA controller 1608).

[0473] When power is applied to the shape memory actuator 112, the voltage may be applied over a fixed time period in the following ways: a) a fixed load cycle with an unregulated voltage, b) a fixed load cycle with a regulated voltage, c) a variable load cycle based on a measured current value, d) a variable load cycle based on a measured voltage value, and e) a variable load cycle based on the square of the measured voltage value. Alternatively, the voltage may be applied to the shape memory actuator 112 over a variable time period based on a measured impedance.

[0474] When an unregulated voltage is applied over a fixed time period in a fixed load cycle, inner loop feedback may be used, and the shape memory actuator may be driven in a fixed load cycle and at an on-time determined by the outer capacitive loop.

[0475] When a voltage regulated over a fixed time period is applied in a fixed load cycle, inner loop feedback may not be used, and the shape memory actuator 112 may be driven in a fixed load cycle and at an on-time determined by the outer capacitive loop.

[0476] When an unadjusted voltage is applied in a variable constant load cycle based on the measured current value, the actual current applied to the shape memory actuator 112 may be measured, and the load cycle may be adjusted during the operation of the shape memory actuator 112 in order to maintain the correct average current.

[0477] When an unadjusted voltage is applied in a variable constant load cycle based on the measured voltage value, the actual voltage applied to the shape memory actuator 112 may be measured, and the load cycle may be adjusted during the operation of the shape memory actuator 112 in order to maintain the correct average voltage.

[0478] When an unadjusted voltage is applied in a variable constant load cycle based on the square of the measured voltage value, the actual voltage applied to the shape memory actuator 112 may be measured, and the load cycle may be adjusted during the operation of the shape memory actuator 112 to maintain the square of the voltage at a level necessary to provide the shape memory actuator 112 with a desired level of power (based on the impedance of the shape memory actuator 112).

[0479] See also Figures 114A-114B, which show other implementations of the SMA controller 1608. Specifically, Figure 114A is an electrical circuit diagram including a microprocessor and various control loops that may be configured to provide a PWM signal that can open and close a switch assembly. The switch assembly may control the current that is allowed to flow through the shape memory actuator. A battery may supply current to the shape memory actuator. Furthermore, 114B discloses a capacitive controller and an internal shape memory actuator controller. The shape memory actuator controller may provide a PWM signal to the pump, which may be modified based on the battery voltage. This may occur at a fixed on-time, and as a result, the capacity may be measured by the capacitive sensor assembly 148 and fed back to the capacitive controller.

[0480] In a preferred embodiment, the load cycle is varied based on the measured battery voltage to provide nearly consistent power. The load cycle is adjusted to compensate for lower battery voltages. The battery voltage may vary for two reasons: 1) as the battery discharges, the voltage slowly decreases, and 2) when a load is applied to the battery, its voltage gradually decreases due to its internal impedance. This occurs in any type of system, and this is compensated for by adjusting the load cycle and thus mitigating lower or varying battery voltages. The battery voltage may be measured by a microprocessor. In other systems, 1) the voltage may be regulated (a regulator is put in to maintain the voltage at a stable voltage), and 2) the feedback may be based on something else (i.e., motor speed or position, and not necessarily measuring the battery voltage).

[0481] Other configurations may be used to control the shape memory actuator. For example, A) the shape memory actuator may be controlled by a fixed load cycle with an unregulated voltage. B) A fixed load cycle with a regulated voltage may be used to compensate for changes in the battery voltage. However, regulating the voltage downward is not very efficient due to the energy of the energy. C) The load cycle may be varied based on changes in current (this may require a more complex measurement circuit). D) The load cycle may be varied based on a measured voltage. E) The load cycle may be varied based on the square of the current or the square of the voltage divided by the resistance. F) The voltage may be applied over a variable time amount based on a measured impedance (e.g., the impedance may be measured using a Wheatstone gauge (not shown)). The impedance of the shape memory actuator may correlate with the strain (i.e., the amount of movement of the SMA may be correlated based on its impedance).

[0482] See also Figure 115. As discussed above, to improve the safety of the injection pump assembly 100, the electrical control assembly 110 may include two separate and independent microprocessors, namely a supervisor processor 1800 and a command processor 1802. Specifically, the command processor 1802 may perform the functions discussed above (e.g., generating the SMA drive signal 1612) and control relay / switch assemblies 1804, 1806, which control the functionality of the shape memory actuators 112, 632 (each, respectively) (in this embodiment). The command processor 1802 may receive feedback from the signal controller 1808 regarding the state (e.g., voltage level) of the voltage signal applied to the shape memory actuators 112, 632. The command processor 1800 may control relay / switch assembly 1810 independently of relay / switch assemblies 1804, 1806. Therefore, when an injection event is desired, both the supervisor processor 1800 and the command processor 1802 must agree that the injection event is appropriate, and both must activate their respective relays / switches. If either the supervisor processor 1800 or the command processor 1802 fails to activate its respective relay / switch, the injection event will not occur. Thus, the safety of the injection pump assembly 100 is improved through the use of the supervisor processor 1800 and the command processor 1802, and through their necessary cooperation and simultaneous occurrence.

[0483] The supervisor processor may prevent the command processor from delivering a command when it is not supported, and may sound an alarm if the command processor fails to deliver a command when it should. The supervisor processor may deactivate a relay / switch assembly if the command processor activates the wrong switch or attempts to apply power for an excessively long time.

[0484] The supervisor processor can redundantly calculate how much insulin should be delivered (i.e., double-check the command processor's calculations). The command processor can determine the delivery schedule, and the supervisor processor can redundantly check these calculations.

[0485] The supervisor can also redundantly maintain profiles (delivery profiles) in RAM, so that the command processor can perform correct calculations even if it has faulty RAM that causes commands to produce incorrect results. The supervisor can use a local copy of the underlying profile for double-checking, for example.

[0486] The supervisor can double-check the AVS measurement, review the AVS calculation, and apply safety checks. A double-check is performed each time an AVS measurement is taken.

[0487] See also Figure 116, one or more of the supervisor processor 1800 and command processor 1802 can perform diagnostics on various parts of the injection pump assembly 100. For example, the voltage dividers 1812 and 1814 may be configured to monitor the voltages (V1 and V2, respectively) sensed at the distal end of the shape memory actuator 112. Knowing the signals applied to the relay / switch assemblies 1804 and 1810, the values ​​of voltages V1 and V2 allow diagnostics to be performed on various components of the circuit shown in Figure 116 (as shown in illustrative diagnostic table 1816).

[0488] As discussed above, as illustrated in Figures 115-116, to improve the safety of the injection pump assembly 100, the electrical control assembly 110 may include multiple microprocessors (e.g., supervisor processor 1800 and command processor 1802), each of which may be required to interact and operate simultaneously to achieve the delivery of one dose of the injectable fluid. If the microprocessors fail to interact / operate simultaneously, the delivery of one dose of the injectable fluid may fail, which may trigger one or more alarms, thus improving the safety and reliability of the injection pump assembly 100.

[0489] A master alarm can be used to track capacity errors over time. Therefore, if the sum of errors becomes too large, the master alarm may be triggered, indicating a potential system malfunction. Thus, the master alarm may indicate that a total capacity comparison has been performed and a discrepancy has been found. A typical discrepancy required to trigger a master alarm might be 1.00 milliliter. The master alarm can monitor the total in a leak-like manner (i.e., the inaccuracy has a horizontal axis of time).

[0490] See also Figures 117A-117B, which illustrate one such exemplary embodiment of such interaction between multiple microprocessors during the delivery of one dose of injectable fluid. Specifically, the command processor 1802 may first determine the initial volume of injectable fluid in the volume sensor chamber 620 1900. The command processor 1802 may then provide the supervisor processor 1800 with a "pump power request" message 1902. Upon receiving the "pump power request" message 1904, the supervisor processor 1800 may, for example, energize the relay / switch 1810 1906 (and thus energize the shape memory actuator 112), and send a "pump power on" message to the command processor 1802 1908. Upon receiving the "pump power on" message 1910, the command processor 1802 may activate the pump assembly 106, for example (by energizing the relay / switch 1804) 1912, and during that time, the supervisor processor 1800 may monitor the operation of the pump assembly 106, for example 1914.

[0491] When the operation of the pump assembly 106 is complete, the command processor 1802 may provide the supervisor processor 1800 with a "pump power off" message 1914. Upon receiving the "pump power off" message 1916, the supervisor processor 1800 may provide the command processor 1802 with a "pump power off" message 1920, by cutting off the power supply to the relay / switch 1810 1918. Upon receiving the "pump power off" message 1922, the command processor 1802 may measure the amount of injectable fluid delivered by the pump assembly 106 1924. This can be achieved by measuring the current amount of fluid in the volume sensor chamber 620 and comparing it to the amount determined above (in step 1900). Once determined 1924, the command processor 1802 may provide the supervisor processor 1800 with a "valve open power request" message 1926. Upon receiving the "Valve Open Power Request" message 1928, the supervisor processor 1800 may energize the relay / switch 1810 1930 (and thus energize the shape memory actuator 632) and send the "Valve Open Power On" message to the command processor 1802 1932. Upon receiving the "Valve Open Power On" message 1934, the command processor 1802 may actuate the measuring valve assembly 610, for example (by energizing the relay / switch 1806) 1936, during which time the supervisor processor 1800 may monitor the actuatement of the measuring valve assembly 610, for example 1938.

[0492] When the operation of the measuring valve assembly 610 is complete, the command processor 1802 may provide the supervisor processor 1800 with a “valve power off” message 1940. Upon receiving the “valve power off” message 1942, the supervisor processor 1800 may de-energize the relay / switch 1810 1944 and provide the command processor 1802 with a “valve power off” message 1946.

[0493] Upon receiving the “Valve Power Off” message 1948, the command processor 1802 may provide the supervisor processor 1800 with the “Valve Close Power Request” message 1950. Upon receiving the “Valve Close Power Request” message 1952, the supervisor processor 1800 may energize the relay / switch 1810 1954 (and thus energize the shape memory actuator 652) and send the “Power On” message to the command processor 1802 1956. Upon receiving the “Power On” message 1958, the command processor 1802 may activate an energizing relay / switch (not shown) configured to energize the shape memory actuator 652 1960, during which time the supervisor processor 1800 may, for example, monitor the operation of the shape memory actuator 652 1962.

[0494] As discussed above (and temporarily referring to Figures 26A, 26B, 27A, 27B, and 28), the shape memory actuator 652 can be fixed on its first end using an electrical contact 654. The other end of the shape memory actuator 652 can be connected to a bracket assembly 656. When the shape memory actuator 652 is activated, it can pull the bracket assembly 656 forward and release the valve assembly 634. In this way, the measuring valve assembly 610 can be activated via the shape memory actuator 632. When the measuring valve assembly 610 is activated, the bracket assembly 656 can automatically latch the valve assembly 610 in the activated position. By activating the shape memory actuator 652, the bracket assembly 656 can be pulled forward and the valve assembly 634 can be released. If the shape memory actuator 632 is no longer activated, the measuring valve assembly 610 may become deactivated when the bracket assembly 656 releases the valve assembly 634. Therefore, the measuring valve assembly 610 can be stopped by activating the shape memory actuator 652.

[0495] When the operation of the shape memory actuator 652 is complete, the command processor 1802 may provide a “power off” message to the supervisor processor 1800 1964. Upon receiving the “power off” message 1966, the supervisor processor 1800 may deactivate the relay / switch 1810 1968 and provide a “power off” message to the command processor 1802 1970. Upon receiving the “power off” message 1972, the command processor 1802 may determine the amount of injectable fluid in the volume sensor chamber 620, and thus enable the command processor 1802 to determine the amount of injectable fluid to be delivered to the user by comparing this measured amount with the amount determined above (in step 1924) 1974.

[0496] If the amount of injectable fluid delivered to the user 1974 is less than the amount of injectable fluid specified for the underlying / bolus injection event, the above procedure may be repeated (via loop 1976).

[0497] Referring to Figure 118, another illustrative example of the interaction between processors 1800 and 1802 during scheduling of one dose of injectable fluid is shown. Command processor 1802 may monitor for the reception of a basic scheduling message or a bolus request message (each, 2000, 2002). Upon reception of either of these messages 2000, 2002, command processor 1802 may provide supervisor processor 1800 with a "delivery request" message 2004, which may set a desired delivery capacity 2006. Upon receiving the "delivery request" message 2008, supervisor processor 1800 may verify the capacity defined by command processor 1802 2004 2010. Once verified 2010, supervisor processor 1800 may provide command processor 1802 with a "delivery accepted" message 2012. Upon receiving the “Delivery Accepted” message in 2014, the command processor 1802 may update the controller (e.g., the controller discussed above and illustrated in Figure 110) in 2016 and perform the delivery of the base / bolus dose of the injectable fluid in 2018. The command processor 1808 may monitor and update the total amount of injectable fluid delivered to the user (as discussed above and illustrated in Figures 117A-117B) in 2022. Once the appropriate amount of injectable fluid has been delivered to the user, the command processor 1802 may provide the supervisor processor 1800 with a “Delivery Completed” message in 2024. Upon receiving the “Delivery Completed” message in 2026, the supervisor processor 1800 may update the total amount of injectable fluid delivered to the user in 2028. If the total volume of injectable fluid delivered to the user (2018) is less than the volume defined above (in step 2004), the injection process discussed above (via loop 2030) may be repeated.

[0498] See also Figure 119, which shows an embodiment of a configuration in which the supervisor processor 1800 and the command processor 1802 can interact while achieving capacitance measurement via the capacitance sensor assembly 148 (as described above).

[0499] Specifically, the command processor 1802 initializes the capacitance sensor assembly 148 2050 and begins collecting data from the capacitance sensor assembly 148 2052, and this process may be repeated for each frequency used in the sinusoidal sweep described above. Each time data is collected for a particular sweep frequency, a data point message may be provided from the command processor 1802 2054, which may be received by the supervisor processor 1800 2056.

[0500] Once data acquisition 2052 is complete for the entire sinusoidal sweep, the command processor 1802 may estimate the volume of injectable fluid to be delivered by the injection pump assembly 100 2058. The command processor 1802 may provide a volume estimation message to the supervisor processor 1800 2060. Upon receiving this volume estimation message 2062, the supervisor processor 1800 may check (i.e., confirm) the volume estimation message 2064. Once checked (i.e., confirmed), the supervisor processor 1800 may provide a verification message to the command processor 1802 2066. Upon receiving from the supervisor processor 1800 2068, the command processor 1802 may set a measurement state for the volume of injectable fluid to be delivered by the volume sensor assembly 148.

[0501] As discussed above, temporarily referring to Figure 11, various embodiments of the injection pump assemblies discussed above (e.g., injection pump assemblies 100, 100', 400, 500) may be configured via a remote control assembly 300. When configured via a remote control assembly 300, the injection pump assembly includes telemetry circuitry (not shown) that enables communication (e.g., wired or wireless) between the injection pump assembly and, for example, the remote control assembly 300, thus enabling the remote control assembly 300 to remotely control the injection pump assembly. The remote control assembly 300 (which may also include telemetry circuitry (not shown) and may be capable of communicating with the injection pump assembly) may include a display assembly 302 and an input assembly 304. The input assembly 304 may include a slider assembly 306 and switch assemblies 308, 310. In other embodiments, the input assembly may include a jog wheel, a plurality of switch assemblies, or equivalent. The remote control assembly 300 may allow the user to program the underlying and bolus delivery events.

[0502] The remote control assembly 300 may include two processors, one of which may be dedicated to wireless communication, for example, to communicating with injection pump assemblies 100, 100', 400, and 500. The second processor included in the remote control assembly, which may be a command processor, and may perform data processing tasks related to configuring injection pump assemblies 100, 100', 400, and 500, for example.

[0503] Furthermore, as discussed above, one embodiment of the electrical control assembly 816 may include three microprocessors. One processor (for example, the CC2510 microcontroller / RF transceiver available from Chipcon AS (Oslo, Norway) may be dedicated to wireless communication, for example, to communicate with the remote control assembly 300. Two further microprocessors (for example, the supervisor processor 1800 and the command processor 1802) may achieve the delivery of injectable fluids (as discussed above). Examples of the supervisor processor 1800 and the command processor 1802 may include, but are not limited to, the MSP430 microcontroller available from Texas Instruments Inc. (Dallas, Texas).

[0504] The OS can be a non-interrupt scheduling system in that it executes all tasks until they are completed, regardless of priority, before the next task can be executed. In addition, context switching may not occur. When a task completes execution, the highest priority task currently scheduled to execute may be executed. If no tasks are scheduled to execute, the OS may put the processor (e.g., supervisor processor 1800 and / or command processor 1802) into a low-power hibernation mode, which can then be woken up when the next task is scheduled. The OS may be used only to manage the main loop code and may remain unaffected by interrupt-based functionality.

[0505] An operating system can be written using the C++ language. Inheritance and virtual functions can be important design elements that enable the easy creation, scheduling, and management of tasks.

[0506] At the heart of an operating system's fundamental structure lies the ability to track system time and control the processor into low-power mode (LPM, also known as hibernation mode). This functionality, along with the control and configuration of all system clocks, can be encapsulated by the SysClocks class.

[0507] The SysClocks class may include functionality to reduce energy consumption by putting a processor (e.g., supervisor processor 1800 and / or command processor 1802) into LPM mode. While in LPM mode, the slower real-time clock continues to run, but the faster system clock that powers the CPU core and most peripherals may be disabled.

[0508] The processor can always be put into LPM mode via provided SysClocks. This function includes all necessary power depletion and power increase sequences, ensuring consistency whenever the processor enters or exits LPM mode. Returning from LPM mode can be initiated by an interrupt based on a slow clock.

[0509] The OS can track three aspects of time: seconds, milliseconds, and time. Regarding seconds, SysClocks may begin counting seconds when the processor emerges from reset. The seconds counter may be based on the slow system clock and therefore can increment regardless of whether the processor is in LPM or full power mode. This, in turn, is the boundary at which the processor resumes from hibernation to perform a previously scheduled task. If a task is scheduled to run immediately after an interrupt handling routine (ISR), the ISR may cause the processor to resume from LPM upon completion, allowing the task to run immediately. Regarding milliseconds, in addition to counting seconds since power-on, SysClocks may also count milliseconds while the processor is in full power mode. Since the fast clock is paused during LPM, the millisecond counter does not increment. Therefore, whenever a task is scheduled to run based on milliseconds, the processor must not be in LPM. Regarding time, time may be represented within SysClocks as the number of seconds since a specific point in time (e.g., seconds since January 1, 2004).

[0510] The SysClocks class can provide useful functionality used throughout the command and supervisor project codebase. Code delay may be necessary to allow hardware to settle or for an action to complete. SysClocks can provide two forms of delay: delays based on seconds or delays based on milliseconds. When a delay is used, the processor can simply wait until the desired amount of time has elapsed before continuing the current code path. During this time, only ISRs may be executed. SysClocks can set or retrieve the current time, providing all the necessary functionality.

[0511] The term "task" can be associated with more complex scheduling systems, and therefore, within an OS, a task may be represented by and referred to as a managed function. The ManagedFunc class can be an abstract base class that provides all the control elements and functionality necessary to manage and schedule desired functionality.

[0512] The ManagedFunc base class may have five control members: two scheduling operation member functions and one pure virtual execution function which may contain managed functionality. All ManagedFunc control members may be hidden from the derived class and may only be set directly by the derived class during creation, thus simplifying usage and improving the safety of injection pump assemblies 100, 100', 400, and 500.

[0513] Function IDs can be set at creation and may never be changed. All function IDs can be defined within a single h file, and the base ManagedFunc constructor can strongly enforce that the same ID should not be used for more than one managed function. IDs can also define the priority of a function (relative to other functions) based on the assigned function ID, with higher-priority functions being assigned lower function IDs. Highest-priority tasks, which are currently scheduled to run, may run before lower-priority tasks.

[0514] All other control members can be used to represent the current scheduled state of a function when it should be executed and when it should be scheduled again for a previously set amount of time (at runtime). Manipulation of these controls and states is possible, but only through public member functions (thus enforcing safety controls in all settings).

[0515] To control the scheduling of managed functions, start and iterate configuration functions may be used. Each of these member functions may be a simple interface that allows the ability to configure or disable iterate configurations, as well as control whether a managed function is in an inactive state, scheduled by seconds, milliseconds, or time.

[0516] Managed functions can be created through inheritance by creating a derived class and defining a pure virtual "executable" function containing code that needs to be subject to scheduling control. The ManagedFunc base class constructor can be based on the function's unique ID, but can also be used to set default control values ​​at startup.

[0517] For example, to create a function that runs 30 seconds after startup and then every 15 seconds thereafter, the desired code is placed in a virtual execution function, and a function ID with a 30-second start time and a 15-second iteration setting scheduled by a seconds state is provided to the constructor.

[0518] The following is an illustrative code example of creating a managed function. In this particular example, a "heartbeat" function is created that is scheduled to run for the first time 1 second after the start of injection pump assemblies 100, 100', 400, and 500, and then every 10 seconds thereafter.

[0519] [ka] The actual execution of managed functions can be controlled and carried out by the SleepManager class. SleepManager may contain an actual priority list of managed functions. This priority list of functions may be automatically populated during the managed function creation process, ensuring that each function is properly created and has a unique ID.

[0520] The primary role of the SleepManager class is to have the "management" function repeatedly called from the processor's main loop and / or an infinite while loop. With each call to management, SleepManager executes all functions that are scheduled to run until SleepManager has exhausted all scheduled functions, at which point SleepManager may put the processor into LPM. When the processor returns from LPM, the management function may be re-entered until the processor is ready to go into LPM again (this process may be repeated, for example, by the user or the system).

[0521] If the processor needs to remain in full power mode for an extended period (for example, while analog / digital conversion is being sampled), SleepManager may provide functionality to disable LPM. While LPM is disabled, management functions can continuously search for scheduled tasks.

[0522] SleepManager may also provide an interface for manipulating scheduling and iterating over the configuration of arbitrary managed functions through the use of a unique ID for the function, which may allow any section of code to perform any necessary scheduling without direct access to the desired ManagedFunc object or unnecessary knowledge of it.

[0523] Wireless circuits contained within each of the i...

Claims

[Claim 1] An invention relating to a fluid delivery system.

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