Infusion pump assembly

Abstract

To provide an infusion pump assembly.SOLUTION: A wearable infusion pump assembly comprises: a reusable housing assembly, comprising a mechanical control assembly having a pump assembly; the pump assembly; at least one shape-memory actuator configured to operate the pump assembly; and at least one valve assembly. The wearable infusion pump assembly further comprises a disposable housing assembly including a reservoir for receiving an infusible fluid. A releasable engagement assembly is configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. A switch assembly is configured to effectuate the pairing functionality of the infusion pump assembly.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of the following provisional patent applications, each of which is incorporated herein by reference in its entirety: U.S. Patent Application No. 61 / 018,054, filed December 31, 2007; U.S. Patent Application No. 61 / 018,042, filed December 31, 2007; U.S. Patent Application No. 61 / 017,989, filed December 31, 2007; U.S. Patent Application No. 61 / 017,989, filed December 31, 2007; No. 18,002, U.S. Patent Application No. 61 / 018,339 filed December 31, 2007, U.S. Patent Application No. 61 / 023,645 filed January 25, 2008, U.S. Patent Application No. 61 / 101,053 filed September 29, 2008, U.S. Patent Application No. 61 / 101,077 filed September 29, 2008, U.S. Patent Application No. 61 / 101,105 filed September 29, 2008.

[0002] FIELD OF THE INVENTION FIELD OF THE INVENTION This application relates generally to fluid delivery systems, and more particularly to infusion pump assemblies. [Background technology]

[0003] (background) Many potentially valuable drugs or compounds, including biologics, are not orally effective due to poor absorption, hepatic metabolism, or other pharmacokinetic factors. In addition, some therapeutic compounds can be absorbed orally, but may need to be administered frequently, making it difficult for patients to maintain the desired schedule. In such cases, parenteral delivery is often employed or may be employed.

[0004] Effective parenteral routes of drug delivery and other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, involve puncturing the skin with a needle or stylet. Insulin is an example of a therapeutic fluid that is self-injected by millions of diabetics. Users of parenterally delivered drugs may benefit from wearable devices that automatically deliver the required drug / compound over a period of time. Summary of the Invention [Problem to be solved by the invention]

[0005] To this end, efforts have been made to design portable and wearable devices for the controlled release of therapeutic agents. Such devices are known to have a reservoir, such as a cartridge, syringe, or bag, and to be electronically controlled. These devices suffer from numerous drawbacks, including a high rate of malfunction. Reducing the size, weight, and cost of these devices is also an ongoing challenge. In addition, these devices are often applied to the skin, posing the challenge of frequent repositioning for application. [Means for solving the problem]

[0006] (Summary of the Invention) According to a first implementation, the wearable infusion pump assembly includes a reusable housing assembly including a mechanical control assembly, a pump assembly, at least one shape-memory actuator configured to operate the pump assembly, and at least one valve assembly. The wearable infusion pump assembly further includes a disposable housing assembly including a reservoir for receiving an infusible fluid. The assembly is configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. The switch assembly is configured to effect pairing functionality of the infusion pump assembly.

[0007] According to another implementation, the wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid. The releasable engagement assembly is configured to enable the reusable housing assembly to releasably engage the disposable housing assembly. The switch assembly is configured to achieve functionality of the infusion pump assembly.

[0008] According to another implementation, a computer program product includes a computer-readable medium having a plurality of instructions stored thereon. When executed by a processor, the instructions cause the processor to perform operations including receiving an initiation signal from a switch assembly included within the wearable infusion pump assembly, the initiation signal indicating a bolus infusion event. The computer-readable medium also includes instructions for receiving a dose signal from the switch assembly indicating at least a portion of a bolus quantity of infusible fluid. The computer-readable medium further includes instructions for rendering an audible quantity signal on the wearable infusion pump assembly in response to the dose signal. Additionally, the computer-readable medium includes instructions for receiving an acknowledgment signal from the switch assembly indicating agreement with the audible quantity signal.

[0009] According to another implementation, a computer program product includes a computer-readable medium having a plurality of instructions stored thereon. When executed by a processor, the instructions cause the processor to perform an operation including transmitting a ping signal from the wearable infusion pump assembly to a remote control assembly. The computer-readable medium also includes instructions for monitoring for receipt of a response signal from the remote control assembly in response to the ping signal. Furthermore, the computer-readable medium includes instructions for asserting an audible detachment alarm on the wearable infusion pump assembly if the response signal is not received within a defined period of time.

[0010] According to another implementation, a computer program product includes a computer-readable medium having a plurality of instructions stored thereon. When executed by a processor, the instructions cause the processor to perform operations including receiving a pairing initiate signal from a switch assembly included within the wearable infusion pump assembly, the pairing initiate signal indicating a pairing event. The computer-readable medium also includes instructions for monitoring for receipt of a pairing request on the wearable infusion pump assembly from a remote control assembly. Further, the computer-readable medium includes instructions for providing a confirmation message to the remote control assembly if a pairing request is received, the confirmation message uniquely identifying the wearable infusion pump assembly.

[0011] According to another implementation, a wearable infusion pump assembly includes a reservoir for receiving an infusible fluid and a fluid delivery system configured to deliver the infusible 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 infusible fluid from the reservoir. The volume sensor assembly includes an acoustically adjacent region having a volume that varies based on the quantity of the infusible 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 gas contained in the acoustically adjacent region.

[0012] According to another implementation, a wearable infusion pump assembly includes a reservoir for receiving an infusible fluid and a fluid delivery system configured to deliver the infusible 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 infusible fluid from the reservoir. The wearable infusion pump assembly also includes a volume sensor assembly configured to receive a quantity of the infusible fluid from the reservoir. The system 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 infusible fluid to the external infusion set. The computer-readable medium also includes instructions for calculating a second volume characteristic after providing a quantity of infusible fluid to the external infusion set. The computer-readable medium further includes instructions for determining whether an occlusion condition has occurred.

[0013] According to another implementation, a wearable infusion pump assembly includes a reservoir for receiving an infusible fluid and a fluid delivery system configured to deliver the infusible 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 infusible fluid from the reservoir. The fluid delivery system further 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 determining a quantity of the infusible fluid to be delivered to a user via the external infusion set. The computer-readable medium also includes instructions for comparing the delivered quantity of the infusible fluid to a delivery target quantity to determine a difference quantity. The computer-readable medium further includes instructions for adjusting a subsequent delivery quantity of the infusible fluid to account for the difference quantity.

[0014] According to another implementation, the wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid. The releasable engagement assembly is configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. The wearable infusion 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 executing one or more hierarchical state machines to achieve delivery of one or more bolus infusion events.

[0015] According to another implementation, a wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid. A releasable engagement assembly is configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. 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 executing one or more hierarchical state machines to achieve delivery of one or more basal infusion events.

[0016] According to another implementation, the wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid. The releasable engagement assembly is configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. The wearable infusion pump assembly further 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 perform operations including executing one or more hierarchical state machines to effectuate execution of one or more occlusion detection events. Have at least one processor do this.

[0017] According to another implementation, the wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid. The releasable engagement assembly is configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. The wearable infusion pump assembly further 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 executing one or more hierarchical state machines to effectuate the execution of one or more pairing events.

[0018] According to another implementation, the wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid. The releasable engagement assembly is configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. The wearable infusion pump assembly further includes a filling station including a supply of infusible fluid. The filling station is configured to releasably fluidly couple the reservoir to effect delivery of the infusible fluid from the filling station to the reservoir.

[0019] According to another implementation, the wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid. The releasable engagement assembly is configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. The wearable infusion pump assembly further includes a removable external infusion set configured to deliver the infusible fluid to a user.

[0020] According to another implementation, the wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid. The wearable infusion pump assembly further includes a releasable engagement assembly configured to allow the reusable housing assembly to rotationally engage the disposable housing assembly.

[0021] According to another implementation, the wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid. The releasable engagement assembly is configured to enable the reusable housing assembly to releasably engage the disposable housing assembly. The wearable infusion pump assembly further includes a bolus switch assembly configured to effect a bolus infusion event.

[0022] According to another implementation, the wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly including a reservoir for receiving an infusible fluid, and a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly.

[0023] According to another implementation, a wearable infusion pump assembly includes a reservoir for receiving an infusible fluid and an external infusion set configured to deliver the infusible fluid to a user. A fluid delivery system is configured to deliver the infusible fluid from the reservoir to the external infusion set. The fluid delivery system includes a volume sensor assembly and a pump assembly for extracting a quantity of the infusible fluid from the reservoir and providing the quantity of the infusible fluid to the volume sensor assembly. The volume sensor assembly is configured to determine a volume of at least a portion of the quantity of fluid. The fluid delivery system also includes a first valve assembly configured to selectively isolate the pump assembly from the reservoir. The fluid delivery system further includes a second valve assembly configured to selectively isolate the volume sensor assembly from the external infusion set.

[0024] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description, drawings, and claims. The present invention provides, for example, the following. (Item 1) 1. A wearable infusion pump assembly comprising: a reusable housing assembly including a mechanical control assembly, the mechanical control assembly including a pump assembly, at least one shape memory actuator configured to actuate the pump assembly, and at least one valve assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly; a switch assembly configured to effectuate pairing functionality of the infusion pump assembly; and An assembly comprising: (Item 2) 1. A wearable infusion pump assembly comprising: a reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly; a switch assembly configured to effectuate pairing functionality of the infusion pump assembly; and An assembly comprising: (Item 3) 1. A computer program product comprising: 1. A computer program product resident on a computer-readable medium comprising a plurality of instructions stored thereon, the instructions, when executed by a processor, causing the processor to perform operations, the operations including: receiving an initiation signal from a switch assembly included within the wearable infusion pump assembly, the initiation signal indicating a bolus infusion event; receiving a dose signal from the switch assembly indicative of at least a portion of a bolus amount of infusible fluid; presenting an audible dose signal on the wearable infusion pump assembly in response to the dose signal; receiving an acknowledgement signal from the switch assembly indicating agreement with the audible quantity signal; Including, products. (Item 4) 1. A computer program product resident on a computer-readable medium comprising a plurality of instructions stored thereon, the instructions, when executed by a processor, causing the processor to perform operations, the operations including: transmitting a ping signal from the wearable infusion pump assembly to a remote control assembly; monitoring for receipt of a response signal from the remote control assembly in response to the ping signal; if the response signal is not received within a prescribed period of time, then asserting an audible detached alarm on the wearable infusion pump assembly. Including, products. (Item 5) 1. A computer program product resident on a computer-readable medium comprising a plurality of instructions stored thereon, the instructions, when executed by a processor, causing the processor to perform operations, the operations including: receiving a pairing initiation signal from a switch assembly included within the wearable infusion pump assembly, the switch assembly indicating a pairing event; monitoring for receipt of a pairing request for the wearable infusion pump assembly from a remote control assembly; providing a confirmation message to the remote control assembly if the pairing request is received, the confirmation message uniquely identifying the wearable infusion pump assembly; Including, products. (Item 6) 1. A wearable infusion pump assembly comprising: a reservoir for receiving an infusible fluid; a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set; the fluid delivery system comprising: a volume sensor assembly configured to receive a quantity of the infusible fluid from the reservoir, the volume sensor assembly comprising: an acoustically continuous region having a volume that varies based on the amount of the infusible fluid received from the reservoir; an acoustic energy emitter configured to provide acoustic energy at a plurality of frequencies to excite gas contained in the acoustically continuous region; Including the assembly. (Item 7) 1. A wearable infusion pump assembly comprising: a reservoir for receiving an infusible fluid; a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set, the fluid delivery system including a volume sensor assembly configured to receive a quantity of the infusible fluid from the reservoir; at least one processor; a computer-readable medium coupled to the at least one processor, the computer-readable medium including a plurality of instructions stored thereon that, when executed by the at least one processor, cause the at least one processor to perform operations, including: calculating a first volumetric characteristic prior to providing the quantity of the infusible fluid to the external infusion set; calculating a second volumetric characteristic after providing the quantity of the infusible fluid to the external infusion set; determining whether an occlusion condition exists; a computer-readable medium, An assembly comprising: (Item 8) 1. A wearable infusion pump assembly comprising: a reservoir for receiving an infusible fluid; a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set, the fluid delivery system including a volume sensor assembly configured to receive a quantity of the infusible fluid from the reservoir; at least one processor; a computer-readable medium coupled to the at least one processor, the computer-readable medium including a plurality of instructions stored thereon that, when executed by the at least one processor, cause the at least one processor to perform operations, including: determining a quantity of the infusible fluid to be delivered to a user via the external infusion set; comparing the amount of the infusible fluid delivered to a target amount to be delivered to determine a difference amount; adjusting a subsequently delivered amount of said infusible fluid to compensate for said differential amount; a computer-readable medium, An assembly comprising: (Item 9) 1. A wearable infusion pump assembly comprising: a reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly; at least one processor; a computer-readable medium coupled to the at least one processor, the computer-readable medium including a plurality of instructions stored thereon that, when executed by the at least one processor, cause the at least one processor to perform operations, including: a computer-readable medium including executing one or more hierarchical state machines to effectuate the delivery of one or more bolus infusion events; An assembly comprising: (Item 10) 1. A wearable infusion pump assembly comprising: a reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly; at least one processor; a computer-readable medium coupled to the at least one processor, the computer-readable medium including a plurality of instructions stored thereon that, when executed by the at least one processor, cause the at least one processor to perform operations, including: a computer-readable medium including executing one or more hierarchical state machines to effect delivery of one or more basal infusion events; An assembly comprising: (Item 11) 1. A wearable infusion pump assembly comprising: a reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; The reusable housing assembly releasably engages the disposable housing assembly. a releasable engagement assembly configured to enable at least one processor; a computer-readable medium coupled to the at least one processor, the computer-readable medium including a plurality of instructions stored thereon that, when executed by the at least one processor, cause the at least one processor to perform operations, including: a computer-readable medium including executing one or more hierarchical state machines to effectuate the execution of one or more occlusion detection events; An assembly comprising: (Item 12) 1. A wearable infusion pump assembly comprising: a reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly; at least one processor; a computer-readable medium coupled to the at least one processor, the computer-readable medium including a plurality of instructions stored thereon that, when executed by the at least one processor, cause the at least one processor to perform operations, including: a computer-readable medium including executing one or more hierarchical state machines to effectuate the execution of one or more pairing events; An assembly comprising: (Item 13) 1. A wearable infusion pump assembly comprising: a reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly; a filling station including a supply of infusible fluid, the filling station configured to releasably fluidly connect the reservoir to effect delivery of the infusible fluid from the filling station to the reservoir; An assembly comprising: (Item 14) 1. A wearable infusion pump assembly comprising: a reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly; a detachable external infusion set configured to deliver the infusible fluid to a user; An assembly comprising: (Item 15) 1. A wearable infusion pump assembly comprising: a reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to rotationally engage the disposable housing assembly; and An assembly comprising: (Item 16) 1. A wearable infusion pump assembly comprising: a reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly; a bolus switch assembly configured to effect a bolus injection event; and An assembly comprising: (Item 17) 1. A wearable infusion pump assembly comprising: a fluid-free reusable housing assembly; a disposable housing assembly including a reservoir for receiving an infusible fluid; a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly; and An assembly comprising: (Item 18) 1. A wearable infusion pump assembly comprising: a reservoir for receiving an infusible fluid; an external infusion set configured to deliver the infusible fluid to a user; a fluid delivery system configured to deliver the infusible fluid from the reservoir to the external infusion set; Equipped with The fluid delivery system comprises: a volume sensor assembly; a pump assembly that extracts a quantity of infusible fluid from the reservoir and provides the quantity of infusible fluid to the volume sensor assembly, the volume sensor assembly configured to determine a volume of at least a portion of the quantity of fluid; a first valve assembly configured to selectively isolate the pump assembly from the reservoir; and a second valve assembly configured to selectively isolate the volume sensor assembly from the external infusion set; and An assembly comprising: [Brief explanation of the drawings]

[0025] [Figure 1]FIG. 1 is a side view of an infusion pump assembly. [Figure 2] 2 is a perspective view of the infusion pump assembly of FIG. 1. FIG. [Figure 3] FIG. 3 is an exploded view of the various components of the infusion pump assembly of FIG. [Figure 4] 4 is a cross-sectional view of the disposable housing assembly of the infusion pump assembly of FIG. [Figure 5] 5A-5C are cross-sectional views of an embodiment of a septum access assembly. [Figure 6] 6A-6B are cross-sectional views of another embodiment of a septum access assembly. [Figure 7] 7A-7B are partial top views of another embodiment of a septum access assembly. [Figure 8] 8A-8B are cross-sectional views of another embodiment of a septum access assembly. [Figure 9] 9 is a perspective view of the infusion pump assembly of FIG. 1 showing the external infusion set. [Figure 10] Figures 10A-10E show multiple hook-and-loop configurations. [Figure 11A] 11A is an isometric view of an alternative embodiment of the remote control assembly and infusion pump assembly of FIG. 1. FIG. [Figure 11B] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11C] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11D] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11E] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11F]11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11G] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11H] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11I] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11J] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11K] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11L] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11M] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11N] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11O] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11P] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11Q] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 11R] 11B-11R show various views of a high-level schematic and flow chart of the infusion pump assembly of FIG. [Figure 12]12A-12F are several display screens presented by the remote control assembly of FIG. 11A. [Figure 13] FIG. 13 is an isometric view of an alternative embodiment of the infusion pump assembly of FIG. [Figure 14] FIG. 14 is an isometric view of the infusion pump assembly of FIG. [Figure 15] FIG. 15 is an isometric view of the infusion pump assembly of FIG. [Figure 16] FIG. 16 is an isometric view of an alternative embodiment of the infusion pump assembly of FIG. [Figure 17] 17 is a top view of the infusion pump assembly of FIG. 16. FIG. [Figure 18] 18 is a top view of the infusion pump assembly of FIG. 16. FIG. [Figure 19] Figure 19A is an exploded view of various components of the infusion pump assembly of Figure 16. Figure 19B is an isometric view of a portion of the infusion pump assembly of Figure 16. [Figure 20] 20 is a cross-sectional view of the disposable housing assembly of the infusion pump assembly of FIG. 16. FIG. [Figure 21] FIG. 21 is a diagram of the fluid paths within the infusion pump assembly of FIG. [Figure 22] 22A-22C are diagrams of fluid paths within the infusion pump assembly of FIG. [Figure 23] FIG. 23 is an exploded view of the various components of the infusion pump assembly of FIG. [Figure 24] 24 is a cutaway isometric view of the pump assembly of the infusion pump assembly of FIG. 16. FIG. [Figure 25] 25A-25D are other isometric views of the pump assembly of FIG. 24. [Figure 26] 26A-26B are isometric views of the metering valve assembly of the infusion pump assembly of FIG. [Figure 27] 27A-27B are side views of the measurement valve assembly of FIGS. 26A-26B. [Figure 28A]28A-28D are views of the metering valve assembly of the infusion pump assembly of FIG. [Figure 28B] 28A-28D are views of the metering valve assembly of the infusion pump assembly of FIG. [Figure 28C] 28A-28D are views of the metering valve assembly of the infusion pump assembly of FIG. [Figure 28D] 28A-28D are views of the metering valve assembly of the infusion pump assembly of FIG. [Figure 29] FIG. 29 is an isometric view of an alternative embodiment of the infusion pump assembly of FIG. [Figure 30] FIG. 30 is an isometric view of an alternative embodiment of the infusion pump assembly of FIG. [Figure 31] 31 is another view of an alternative embodiment of the infusion pump assembly of FIG. 9. FIG. [Figure 32] FIG. 32 is an exploded view of another embodiment of an infusion pump assembly. [Figure 33] 33 is another exploded view of the infusion pump assembly of FIG. 32. FIG. [Figure 34] 34A-34B show another embodiment of an infusion pump assembly. [Figure 35] 35A-35C are top, side, and bottom views of the reusable housing assembly of the infusion pump assembly of FIG. [Figure 36] FIG. 36 is an exploded view of the reusable housing assembly of FIGS. 35A-35C. [Figure 37] FIG. 37 is an exploded view of the reusable housing assembly of FIGS. 35A-35C. [Figure 38A] FIG. 38A is an exploded view of the reusable housing assembly of FIGS. 35A-35C. [Figure 38B] 38B-38D are top, side, and bottom views of one embodiment of a dust cover. [Figure 38C] 38B-38D are top, side, and bottom views of one embodiment of a dust cover. [Figure 38D] 38B-38D are top, side, and bottom views of one embodiment of a dust cover. [Figure 39] 39A-39C are top, side, and bottom views of the electrical control assembly of the reusable housing assembly of FIGS. 35A-35C. [Figure 40] 40A-40C are top, side, and bottom views of the base plate of the reusable housing assembly of FIGS. 35A-35C. [Figure 41] 41A-41B are perspective top and bottom views of the substrate of FIGS. 40A-40C. [Figure 42] 42A-42C are top, side, and bottom views of the base plate of the reusable housing assembly of FIGS. 35A-35C. [Figure 43] 43A-43B show the mechanical control assembly of the reusable housing assembly of FIGS. 35A-35C. [Figure 44] 44A-44C show the mechanical control assembly of the reusable housing assembly of FIGS. 35A-35C. [Figure 45] 45A-45B show the pump plunger and reservoir valve of the mechanical control assembly of the reusable housing assembly of FIGS. 35A-35C. [Figure 46] 46A-46E show the plunge pumper and reservoir valve of the mechanical control assembly of the reusable housing assembly of FIGS. 35A-35C. [Figure 47] 47A-47B show the measurement valve of the mechanical control assembly of the reusable housing assembly of FIGS. 35A-35C. [Figure 48] 48 is an exploded view of the disposable housing assembly of the infusion pump assembly of FIG. [Figure 49A] 49A is a top view of the disposable housing assembly of FIG. [Figure 49B] FIG. 49B is a cross-sectional view of the disposable housing assembly of FIG. 49A taken along BB. [Figure 49C]FIG. 49C is a cross-sectional view of the disposable housing assembly of FIG. 49A taken along CC. [Figure 50] 50A-50C show the base portion of the disposable housing assembly of FIG. [Figure 51] 51A-51C show the fluid pathways of the disposable housing assembly of FIG. [Figure 52] 52A-52C show the membrane assembly of the disposable housing assembly of FIG. [Figure 53] 53A-53C show the top portion of the disposable housing assembly of FIG. [Figure 54] 54A-54C show the leaflet insert of the disposable housing assembly of FIG. [Figure 55] 55A-55B show the locking ring assembly of the infusion pump assembly of FIG. [Figure 56] 56A-56B show the locking ring assembly of the infusion pump assembly of FIG. [Figure 57] 57-58 are isometric views of the infusion pump assembly and fill adapter. [Figure 58] 57-58 are isometric views of the infusion pump assembly and fill adapter. [Figure 59] 59-64 are various views of the fill adapter of FIG. [Figure 60] 59-64 are various views of the fill adapter of FIG. [Figure 61] 59-64 are various views of the fill adapter of FIG. [Figure 62] 59-64 are various views of the fill adapter of FIG. [Figure 63] 59-64 are various views of the fill adapter of FIG. [Figure 64] 59-64 are various views of the fill adapter of FIG. [Figure 65] FIG. 65 is an isometric view of another embodiment of a fill adapter. [Figure 66]66-67 show another embodiment of an infusion pump assembly and fill adapter. [Figure 67] 66-67 show another embodiment of an infusion pump assembly and fill adapter. [Figure 68] 68-74 are various views of the fill adapter of FIG. [Figure 69] 68-74 are various views of the fill adapter of FIG. [Figure 70] 68-74 are various views of the fill adapter of FIG. [Figure 71] 68-74 are various views of the fill adapter of FIG. [Figure 72] 68-74 are various views of the fill adapter of FIG. [Figure 73] 68-74 are various views of the fill adapter of FIG. [Figure 74] 68-74 are various views of the fill adapter of FIG. [Figure 75] 75-80 show various views of an embodiment of a battery charger. [Figure 76] 75-80 show various views of an embodiment of a battery charger. [Figure 77] 75-80 show various views of an embodiment of a battery charger. [Figure 78] 75-80 show various views of an embodiment of a battery charger. [Figure 79] 75-80 show various views of an embodiment of a battery charger. [Figure 80] 75-80 show various views of an embodiment of a battery charger. [Figure 81] 81-89 show various embodiments of the battery charger / docking station. [Figure 82] 81-89 show various embodiments of the battery charger / docking station. [Figure 83] 81-89 show various embodiments of the battery charger / docking station. [Figure 84] 81-89 show various embodiments of the battery charger / docking station. [Figure 85] 81-89 show various embodiments of the battery charger / docking station. [Figure 86] 81-89 show various embodiments of the battery charger / docking station. [Figure 87] 81-89 show various embodiments of the battery charger / docking station. [Figure 88] 81-89 show various embodiments of the battery charger / docking station. [Figure 89] 81-89 show various embodiments of the battery charger / docking station. [Figure 90A] 90A-90C are various views of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 90B] 90A-90C are various views of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 90C] 90A-90C are various views of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 91] 91A-91I are various views of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 92] 92A-92I are various views of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 93] 93A-93I are various views of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 94] 94A-94F are various views of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 95] FIG. 95 is an exploded view of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 96]FIG. 96 is a diagram of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 97] FIG. 97 is a two-dimensional graph of the performance characteristics of the volume sensor assembly of FIG. [Figure 98] FIG. 98 is a two-dimensional graph of the performance characteristics of the volume sensor assembly of FIG. [Figure 99] FIG. 99 is a two-dimensional graph of the performance characteristics of the volume sensor assembly of FIG. [Figure 100] FIG. 100 is a diagram of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 101] Fig. 101 is a two-dimensional graph of the performance characteristics of the volume sensor assembly of Fig. 100. Fig. 101 is a two-dimensional graph of the performance characteristics of the volume sensor assembly of Fig. 100. [Figure 102] Not specified. [Figure 103] FIG. 103 is a diagram of a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 104] FIG. 104 is a two-dimensional graph of the performance characteristics of the volume sensor assembly included within the infusion pump assembly of FIG. [Figure 105] FIG. 105 is a two-dimensional graph of the performance characteristics of the volume sensor assembly included within the infusion pump assembly of FIG. [Figure 106] FIG. 106 is a two-dimensional graph of the performance characteristics of the volume sensor assembly included within the infusion pump assembly of FIG. [Figure 107] FIG. 107 is a two-dimensional graph of the performance characteristics of the volume sensor assembly included within the infusion pump assembly of FIG. [Figure 108] FIG. 108 is a two-dimensional graph of the performance characteristics of the volume sensor assembly included within the infusion pump assembly of FIG. [Figure 109] FIG. 109 is a diagram of a control model for a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 110]FIG. 110 is a diagram of an electrical control assembly for the volume sensor assembly included within the infusion pump assembly of FIG. [Figure 111] FIG. 111 is a diagram of a volume controller for a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 112] FIG. 112 is a diagram of the feed forward controller of the volume controller of FIG. [Figure 113] 113-114 show diagrammatically an SMA controller implementation of the volume controller of FIG. [Figure 114] 113-114 show diagrammatically an SMA controller implementation of the volume controller of FIG. [Figure 114A] 114A-114B are alternative implementations of an SMA controller. [Figure 114B] 114A-114B are alternative implementations of an SMA controller. [Figure 115] FIG. 115 illustrates diagrammatically a multi-processor control configuration that may be included within the infusion pump assembly of FIG. [Figure 116] FIG. 116 is a diagram of a multi-processor control configuration that may be included within the infusion pump assembly of FIG. [Figure 117A] 117A-117B illustrate the multi-processor functionality diagrammatically. [Figure 117B] 117A-117B illustrate the multi-processor functionality diagrammatically. [Figure 118] Figure 118 shows a diagram of the multi-processor functionality. [Figure 119] Figure 119 shows a diagram of the multi-processor functionality. [Figure 120A] Figures 120A-120E graphically illustrate various software layers. Figures 120B-120C illustrate various state diagrams. Figure 120D graphically illustrates device interactions. Figure 120E graphically illustrates device interactions. [Figure 120B]Figures 120A-120E graphically illustrate various software layers. Figures 120B-120C illustrate various state diagrams. Figure 120D graphically illustrates device interactions. Figure 120E graphically illustrates device interactions. [Figure 120C] Figures 120A-120E graphically illustrate various software layers. Figures 120B-120C illustrate various state diagrams. Figure 120D graphically illustrates device interactions. Figure 120E graphically illustrates device interactions. [Figure 120D] Figures 120A-120E graphically illustrate various software layers. Figures 120B-120C illustrate various state diagrams. Figure 120D graphically illustrates device interactions. Figure 120E graphically illustrates device interactions. [Figure 120E] Figures 120A-120E graphically illustrate various software layers. Figures 120B-120C illustrate various state diagrams. Figure 120D graphically illustrates device interactions. Figure 120E graphically illustrates device interactions. [Figure 121] FIG. 121 illustrates diagrammatically a volume sensor assembly included within the infusion pump assembly of FIG. [Figure 122] FIG. 122 shows diagrammatically the interconnection of the various systems of the infusion pump assembly of FIG. [Figure 123] Figure 123 shows a schematic of the basal-bolus infusion events. [Figure 124] Figure 124 shows a schematic of the basal-bolus infusion events. [Figure 125A] FIG. 125A12G shows a hierarchical state machine. [Figure 125B] FIG. 125A12G shows a hierarchical state machine. [Figure 125C] FIG. 125A12G shows a hierarchical state machine. [Figure 125D] FIG. 125A12G shows a hierarchical state machine. [Figure 125E] FIG. 125A12G shows a hierarchical state machine. [Figure 125F] FIG. 125A12G shows a hierarchical state machine. [Figure 125G]FIG. 125A12G shows a hierarchical state machine. [Figure 126A] Figures 126A-126M show a hierarchical state machine. [Figure 126B] Figures 126A-126M show a hierarchical state machine. [Figure 126C] Figures 126A-126M show a hierarchical state machine. [Figure 126D] Figures 126A-126M show a hierarchical state machine. [Figure 126E] Figures 126A-126M show a hierarchical state machine. [Figure 126F] Figures 126A-126M show a hierarchical state machine. [Figure 126G] Figures 126A-126M show a hierarchical state machine. [Figure 126H] Figures 126A-126M show a hierarchical state machine. [Figure 126I] Figures 126A-126M show a hierarchical state machine. [Figure 126J] Figures 126A-126M show a hierarchical state machine. [Figure 126K] Figures 126A-126M show a hierarchical state machine. [Figure 126L] Figures 126A-126M show a hierarchical state machine. [Figure 126M] Figures 126A-126M show a hierarchical state machine. [Figure 127] FIG. 127 is an exemplary schematic diagram of a split ring resonator antenna. [Figure 128] FIG. 128 is an exemplary schematic diagram of a medical device configured to utilize a split ring resonator antenna. [Figure 129] FIG. 129 is an exemplary schematic diagram of a split ring resonator antenna and a transmission line from a medical injection device. [Figure 130] FIG. 130 is a graph of the return loss of a split ring resonator antenna before contact with human skin. [Figure 130A]FIG. 130A is a graph of the return loss of a split ring resonator antenna while in contact with human skin. [Figure 131] FIG. 131 is an exemplary schematic diagram of a split ring resonator antenna integrated into a device that operates in close proximity to a dielectric material. [Figure 132] FIG. 132 is a schematic diagram of the internal and external dimensions of an exemplary embodiment. [Figure 133] FIG. 133 is a graph of the return loss of a non-split ring resonator antenna before contact with human skin. [Figure 133A] FIG. 133A is a graph of the return loss of a non-split ring resonator antenna while in contact with human skin.

[0026] Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION OF THE INVENTION

[0027] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 1-3, infusion pump assembly 100 includes a reusable housing assembly 102. Reusable housing assembly 102 may be constructed from any suitable material, such as a hard or rigid plastic that resists compression. For example, the use of durable materials and parts may improve quality and reduce costs by providing a longer-lasting, more durable reusable part and providing better protection for the components placed therein.

[0028] Reusable housing assembly 102 may include a mechanical control assembly 104 having a pump assembly 106 and at least one valve assembly 108. Reusable housing assembly 102 may also include an electrical control assembly 110 configured to provide one or more control signals to mechanical control assembly 104 to achieve basal and / or bolus delivery of the infusible fluid to a user. Disposable housing assembly 114 may include valve assembly 108, which may be configured to control the flow rate of the infusible fluid through the fluid pathway. Reusable housing assembly 102 may also include pump assembly 106, which may be configured to pump the infusible fluid from the fluid pathway to a user.

[0029] Electrical control assembly 110 may monitor and control the amount of infusible fluid that has been and / or is being dispensed. For example, electrical control assembly 110 may receive a signal from volume sensor assembly 148, calculate the amount of infusible fluid just dispensed, and determine whether enough infusible fluid has been dispensed based on the dose required by the user. If enough infusible fluid has not been dispensed, electrical control assembly 110 may determine that more infusible fluid should be dispensed. Electrical control assembly 110 may provide an appropriate signal to mechanical control assembly 104 so that the additional required dose may be dispensed, or electrical control assembly 110 may provide an appropriate signal to mechanical control assembly 104 so that an additional dose may be dispensed with the next dose. Alternatively, if too much infusible fluid has been dispensed, electrical control assembly 110 may provide an appropriate signal to mechanical control assembly 104 so that less infusible fluid may be dispensed with the next dose.

[0030] The mechanical control assembly 104 may include at least one shape memory actuator 112. The pump assembly 106 and / or valve assembly 108 of the mechanical control assembly 104 may be actuated by at least one shape memory actuator, e.g., a shape memory wire of wire or spring configuration. The shape memory actuator 112 may be operably connected to and activated by an electrical control assembly 110, which may 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 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. The shape memory actuator 112 may be a shape memory wire constructed of a nickel / titanium alloy, such as NITINOL® or FLEXINOL®.

[0031] Infusion pump assembly 100 may include a volume sensor assembly 148 configured to monitor the amount of fluid infused by infusion pump assembly 100. For example, volume sensor assembly 148 may employ, for example, acoustic volume sensing. Acoustic volume measurement techniques are described in U.S. Patent Nos. 5,575,310 and 5,755,683, assigned to DEKA Products Limited Partnership, and U.S. Patent Application Publication Nos. US 2007 / 0228071 A1, US 2007 / 0219496 A1, and US 2007 / 0228072 A1, the entire disclosures of which are incorporated herein by reference. Other alternative techniques for measuring flow rate may also be used, such as Doppler-based methods, the use of Hall-effect sensors in combination with vane or flapper valves, the use of strain beams (e.g., involving a flexible member covering a fluid reservoir to sense deflection of the flexible member), the use of volume sensing with plates, or thermal time-of-flight methods, which are the subject of U.S. Patent Application Nos. 11 / 704,899, filed February 9, 2007, entitled "Fluid Delivery Systems and Methods," the entire disclosure of which is incorporated herein by reference. Infusion pump assembly 100 may be configured such that volume measurements produced by volume sensor assembly 148 may be used to control the amount of infusible fluid infused into the user through a feedback loop.

[0032] Infusion pump assembly 100 may further include a disposable housing assembly 114. For example, disposable housing assembly 114 may be configured for a single use or for use for a specified period of time, such as, for example, three days or any other amount of time. Disposable housing assembly 114 may be configured such that any components in infusion pump assembly 100 that come into contact with an infusible fluid are disposed on and / or inside disposable housing assembly 114. For example, fluid pathways or channels, including a reservoir, may be positioned within disposable housing assembly 114 and may be configured for a single use or for a specified number of uses before disposal. The disposable nature of disposable housing assembly 114 may improve sanitation of infusion pump assembly 100.

[0033] 4 , disposable housing assembly 114 may be configured to releasably engage reusable housing assembly 102 and includes cavity 116 having reservoir 118 for receiving an infusible fluid (not shown), e.g., insulin. Such releasable engagement may be achieved, for example, by a threaded, twist-lock, or compression-fit arrangement. Disposable housing assembly 114 and / or reusable housing assembly 102 may include an alignment assembly configured to assist in aligning disposable housing assembly 114 and reusable housing assembly 102 for engagement in a particular orientation. Similarly, base knot 120 and top knot 122 may be used as indicators of alignment and full engagement.

[0034] The cavity 116 may be at least partially formed by and integral with 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 a base portion 128 of the disposable housing assembly 114. For example, the membrane assembly 124 may be positioned over 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 sealing, and / or a compression fit, 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 may be non-pressurized and in fluid communication with a fluid pathway (not shown). The membrane assembly 124 may be at least partially collapsible, and the cavity 116 may include a vent assembly, thereby advantageously preventing the buildup of a vacuum space within the reservoir 118 as the infusible fluid is delivered from the reservoir 118 to the fluid pathway. In a preferred embodiment, the membrane assembly 124 is fully collapsible, thus allowing for full delivery of the infusible 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 infusible fluid.

[0035] The membranes and reservoirs described herein may be made from materials including, but not limited to, silicone, nitrile, and any other material that has the desired elasticity and properties to function as described herein. Additionally, other structures can serve the same purpose.

[0036] The use of a partially collapsible, non-pressurized reservoir may advantageously prevent air buildup in the reservoir as the fluid in the reservoir is depleted. Air buildup in a vented reservoir can prevent fluid from escaping from the reservoir, particularly when the system is tilted such that an air pocket is interposed between the fluid contained in the reservoir and the reservoir's septum. Tilting of the system is expected during normal operation as a wearable device.

[0037] Reservoir 118 may be conveniently sized to hold a sufficient insulin supply for delivery over one or more days. For example, reservoir 118 may hold approximately 1.00 to 3.00 ml of insulin. A 3.00 ml insulin reservoir may correspond to approximately a three-day supply for approximately 90% of potential users. In other embodiments, reservoir 118 may be any size or shape and may be adapted to hold any amount of insulin or other infusible fluid. In some embodiments, the size and shape of cavity 116 and reservoir 118 are related to the type of infusible fluid that cavity 116 and reservoir 118 are adapted to hold.

[0038] Disposable housing assembly 114 may include support member 132 ( FIG. 3 ) configured to prevent accidental compression of reservoir 118. Compression of reservoir 118 may result in an unintended volume of infusible fluid being forced through the fluid pathway to the user. In a preferred embodiment, reusable housing assembly 102 and disposable housing assembly 114 may be constructed from a rigid material that is not easily compressible. However, as an added precaution, support member 132 may be included within disposable housing assembly 114 to prevent compression of infusion pump assembly 100 and cavity 116 therein. Support member 132 may be a rigid protrusion from base portion 128. For example, support member 132 may be positioned within cavity 116 and prevent compression of reservoir 118.

[0039] As discussed above, cavity 116 may be configured to provide sufficient space to ensure that there is always some void even when reservoir 118 is filled with infusible fluid. Thus, if infusion pump assembly 100 is accidentally compressed, infusible fluid may not be forced through cannula assembly 136 (e.g., shown in FIG. 9).

[0040] Cavity 116 may include a septum assembly 146 ( FIG. 3 ) configured to allow reservoir 118 to be filled with an infusible fluid. Septum assembly 146 may be a conventional septum made of rubber or plastic and may have a one-way fluid valve configured to allow a user to fill reservoir 118 from a syringe or other filling device. In some embodiments, septum 146 may be located on top of membrane assembly 124. In these embodiments, cavity 116 may include a support structure (e.g., support member 132 in FIG. 3 ) to support an area around the backside of the septum to maintain the integrity of the septum when a needle is introducing the infusible fluid into cavity 116. The support structure may be configured to support the septum while still allowing the introduction of a needle to introduce the infusible fluid into cavity 116.

[0041] Infusion pump assembly 100 may include an overfill prevention assembly (not shown), which may, for example, protrude into cavity 116 and may, for example, prevent overfilling of reservoir 118. That's fine too.

[0042] In some embodiments, reservoir 118 may be configured to be filled multiple times. For example, reservoir 118 may be refillable through septum assembly 146. Electronic control assembly 110 may monitor the level of infusible fluid in reservoir 118 as the infusible fluid may be dispensed to a user. When the level reaches a low point, electronic control assembly 110 may provide a signal, such as a light or vibration, to the user that reservoir 118 needs to be refilled. A syringe or other filling device may be used to fill reservoir 118 through septum 146.

[0043] Reservoir 118 may be configured to be filled once. For example, a refill prevention assembly (not shown) may be utilized to prevent refilling of reservoir 118 so that disposable housing assembly 114 may be used only once. The refill prevention assembly (not shown) may be a mechanical or electromechanical device. For example, insertion of a syringe into septum assembly 146 to fill reservoir 118 may trigger a shutter to close over septum 146 after one fill, thus preventing further access to septum 146. Similarly, a sensor may indicate to electronic control assembly 110 that reservoir 118 has been filled once, and may trigger a shutter to close over septum 146 after one fill, thus preventing further access to septum 146. Other means of preventing refilling may be utilized and are considered within the scope of the present disclosure.

[0044] As discussed above, disposable housing assembly 114 may include a septum assembly 146, which may be configured to allow reservoir 118 to be filled with an accessible fluid. Septum assembly 146 may be a conventional septum made of rubber or any other material that may function as a septum, or in other embodiments, septum assembly 146 may be a one-way fluid valve made of plastic or other material, without limitation. In various embodiments, including the exemplary embodiment, septum assembly 146 is configured to allow a user to fill reservoir 118 from a syringe or other filling device. Disposable housing assembly 114 may include a septum access assembly, which may be configured to limit the number of times a user may refill reservoir 118.

[0045] 5A-5C, for example, septum access assembly 152 may include a shutter assembly 154 that may be carried in an "open" position by a tab assembly 156 configured to fit within a slot assembly 158. Penetration of septum 146 with a filling syringe 160 may position shutter assembly 154 downward, disengaging tab assembly 156 from slot assembly 158. Once disengaged, spring assembly 162 may displace shutter assembly 154 in the direction of arrow 164, such that septum 146 is no longer accessible to the user.

[0046] 6A, an alternative embodiment septum access assembly 166 is shown in the "open" position. Similar to septum access assembly 152, septum access assembly 166 includes a shutter assembly 168 and a spring assembly 170.

[0047] 6B, an alternative embodiment of septum access assembly 172 is shown in an "open" position in which tab 178 may engage slot 180. Similar to septum access assembly 166, septum access assembly 172 includes a shutter assembly 174 and a spring assembly 176. Once shutter assembly 172 is moved to the "closed" position (which may, for example, prevent further access of septum 146 by a user), tab 178 may at least partially engage slot 180a. The engagement between tab 178 and slot 180a locks shutter assembly 172 in the "closed" position, preventing the shutter from opening. This may prevent tampering or reopening of the assembly 172. A spring tab 182 on the shutter assembly 172 may bias the tab 178 into engagement with the slot 180a.

[0048] However, in various embodiments, the septum access assembly need not be linearly actuated. For example, referring also to FIGS. 7A-7B , an alternative embodiment septum access assembly 184 is shown including a shutter assembly 186 configured to pivot about an axis 188. When positioned in the open position (as shown in FIG. 7A ), the septum 146 may be accessible via a passageway 190 (in the shutter assembly 186) that is aligned with, for example, a passageway 192 in the surface of the disposable housing assembly 114. However, similar to septum access assemblies 166, 172, piercing the septum 146 with the filling syringe 160 (see FIG. 6B ) may displace the shutter assembly 186 in a clockwise direction, such that the passageway 190 (in the shutter assembly 186) is no longer aligned with, for example, the passageway 192 in the surface of the disposable housing assembly 114, thus preventing access to the septum 146.

[0049] 8A-8B , an alternative embodiment septum access assembly 194 is shown. Similar to septum access assemblies 166, 172, septum access assembly 194 includes a shutter assembly 196 and a spring assembly 198 configured to bias shutter assembly 196 in the direction of arrow 200. To fill reservoir 118, a filling assembly 202 may be used. Filling assembly 202 may include a shutter displacement assembly 204 that displaces shutter assembly 196 in the direction of arrow 206, which in turn aligns passageway 208 in shutter assembly 196 with passageway 210 in septum 146 and septum access assembly 194, thus allowing filling syringe assembly 212 to penetrate septum 146 and filling reservoir 118.

[0050] Infusion pump assembly 100 may include sealing assembly 150 ( FIG. 3 ) configured to provide a seal between reusable housing assembly 102 and disposable housing assembly 114. For example, when reusable housing assembly 102 and disposable housing assembly 114 are engaged, e.g., via a rotating threaded engagement, a twist-lock engagement, or a compression engagement, reusable housing assembly 102 and disposable housing assembly 114 may fit together securely, thus forming a seal. In some embodiments, a more secure seal may be desirable. Accordingly, sealing assembly 150 may include an O-ring assembly (not shown). Alternatively, sealing assembly 150 may include an overmolded seal assembly (not shown). Use of an O-ring assembly or overmolded seal assembly may provide a compressible rubber or plastic layer between reusable housing assembly 102 and disposable housing assembly 114 when engaged, thus making the seal more secure by preventing penetration by external fluids. In some cases, the O-ring assembly may prevent accidental disengagement. For example, sealing assembly 150 may be a watertight assembly, thus allowing a user to wear infusion pump assembly 100 while swimming, bathing, or exercising.

[0051] 9 , infusion pump assembly 100 may include an external infusion set 134 configured to deliver an infusible fluid to a user. External infusion set 134 may be in fluid communication with cavity 118, for example, through a fluid pathway. External infusion set 134 may be disposed adjacent to infusion pump assembly 100. Alternatively, external infusion set 134 may be configured for application remotely from infusion pump assembly 100, as discussed in more detail below. External infusion set 134 may include a cannula assembly 136, which may include a needle or disposable cannula 138, and a tubing assembly 140. Tubing assembly 140 may be configured to connect reservoir 118, for example, through a fluid pathway. For example, it may communicate with cannula assembly 138 directly or through cannula interface 142 .

[0052] The external infusion set 134 may be a tethered infusion set, as discussed above with respect to application remote 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 any length desired by the user (e.g., 3-18 inches). The infusion pump assembly 100 may be worn on the user's skin through the use of an adhesive patch 144; however, the length of the tubing assembly 140 may alternatively allow the user to wear the infusion pump assembly 100 in their pocket. This may be beneficial for users whose skin is easily irritated by the application of the adhesive patch 144. Similarly, wearing and / or securing the infusion pump assembly 100 in their pocket may be preferable for users who engage in physical activity.

[0053] In addition to / as an alternative to adhesive patch 144, a hook-and-loop system (e.g., Velcro USA) may be used to allow for easy attachment / removal of the infusion pump assembly (e.g., infusion pump assembly 100) to / from a user. A hook and loop system (such as the Velcro system offered by Velcro.com, Inc., Manchester, NH) may be utilized. Accordingly, adhesive patch 144 may be attached to the user's skin and may include an outwardly facing hook or loop surface. In addition, the underside of disposable housing assembly 114 may include a complementary hook or loop surface. Depending on the separation resistance of the particular type of Velcro.com system employed, the strength of the hook and loop connection may be greater than the strength of the adhesive to skin connection. Accordingly, various hook and loop surface patterns may be utilized to adjust the strength of the hook and loop connection.

[0054] 10A-10E, five examples of such hook and loop surface patterns are shown. For illustrative purposes, assume that the entire underside of the disposable housing assembly 114 is covered with "loop" material. Thus, the strength of the hook and loop connection may be adjusted by varying the pattern (i.e., amount) of "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 "hook" material (as shown in FIG. 10A), multiple concentric circles 222, 224 of "hook" material (as shown in FIG. 10B), multiple radial spokes 226 of "hook" material (as shown in FIG. 10C), multiple radial spokes 228 combined with a single outer circle 230 of "hook" material (as shown in FIG. 10D), and multiple radial spokes 232 combined with multiple concentric circles 234, 236 of "hook" material (as shown in FIG. 10E).

[0055] Additionally, and referring also to FIG. 11A , in one exemplary embodiment of the infusion pump assembly described above, infusion pump assembly 100′ may be configured via remote control assembly 300. In this particular embodiment, infusion pump assembly 100′ may include telemetry circuitry (not shown) that enables communication (e.g., wired or wireless) between infusion pump assembly 100′ and, for example, remote control assembly 300, thereby enabling remote control assembly 300 to remotely control infusion pump assembly 100′. Remote control assembly 300 (which may also include telemetry circuitry (not shown) and may be capable of communicating with infusion pump assembly 100′) may include a display assembly 302 and an input assembly 304. 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, multiple switch assemblies, or the like.

[0056] The remote control assembly 300 may include the ability to pre-program basal rates, bolus alarms, delivery limits, and allow the user to view history and establish user preferences. The remote control assembly 300 may also include a glucose strip reader.

[0057] During use, remote control assembly 300 may provide instructions to infusion pump assembly 100' via wireless communication channel 312 established between remote control assembly 300 and infusion pump assembly 100'. Thus, a user may use remote control assembly 300 to program / configure infusion pump assembly 100'. Some or all of the communications between remote control assembly 300 and infusion pump assembly 100' may be encrypted to provide an enhanced level of security.

[0058] Communication between the remote control assembly 300 and the infusion pump assembly 100' may be achieved utilizing a standard communication protocol. Furthermore, communication between various components contained within the infusion pump assembly 100, 100' may be achieved using the same protocol. One example of such a communication protocol is the Packet Communication Gateway Protocol (PCGP) developed by DEKA Research & Development (Manchester, NH). As discussed above, the infusion pump assembly 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 for enabling the infusion pump assembly 100, 100' to communicate with the remote control assembly 300. Thus, the remote control assembly 300 may include one or more electrical components, examples of which may include, but are not limited to, a command processor and a wireless processor for enabling the remote control assembly 300 to communicate with the infusion pump assembly 100, 100'. A high-level diagram of one example of such a system is shown in FIG. 11B.

[0059] Each of these electrical components may be manufactured by a different component supplier and may therefore utilize specific (i.e., unique) communication commands. Thus, efficient communication between such disparate components may be achieved through the use of a standard communication protocol.

[0060] PCGP may be a flexible, extensible software module that may be used on processors within infusion pump assembly 100, 100' and remote control assembly 300 to build and send packets. PCGP may abstract various interfaces and provide a unified application programming interface (API) to various applications running on each processor. PCGP may also provide an adaptive interface to various drivers. For illustrative purposes only, PCGP may have the conceptual structure shown in FIG. 11C for a given processor.

[0061] PCGP may ensure data integrity by utilizing a cyclic redundancy check (CRC). PCGP may also provide guaranteed delivery status. For example, every new message should have a reply. If such a reply is not returned in time, the message may time out and PCGP may generate a negative acknowledgement reply message (i.e., NACK) to the application. Thus, the message reply protocol may inform the application whether it should retry sending the message.

[0062] PCGP may also limit the number of messages sent on activation from a given node, To provide a deterministic approach to message delivery, a flow control mechanism may be coupled at the driver level, allowing individual nodes to have different amounts of buffers without dropping packets. When a node runs out of buffers, the driver may provide backpressure to other nodes, preventing them from sending new messages.

[0063] PCGP may use a shared buffer pool strategy to minimize data copies and may avoid mutexes, which may have a minor impact on the APIs used to send / receive messages to 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 subclassed from the bridge base class. Drivers may derive from the bridge class or communicate with or own derived bridge classes.

[0064] PCGP may be designed to run in embedded environments, with or without an operating system, by using semaphores to protect shared data so that some calls are reentrant and can operate on multiple threads. One illustrative example of such an implementation is shown in FIG. 11D. PCGP may operate in the same way in both environments, but there may be versions of the calls for specific processor types (e.g., ARM 9 / OS versions). Thus, the functionality may be the same, but there may be an operating system abstraction layer with slightly different calls tailored to, for example, the ARM 9 Nucleus OS environment.

[0065] Referring also to FIG. 11E, the PCGP may: Allows multiple send / return calls to occur (on Pilot's ARM 9 on multiple reentrant tasks) Multiple drivers for RX and TX on different interfaces that operate asynchronously · Provides packet ordering for sending / receiving and deterministic timeouts for sending messages.

[0066] Each software object may ask the buffer manager for the next buffer it will use and then give that buffer to another object. Buffers may be passed automatically from one exclusive owner to another, and a queue may be generated automatically by ordering buffers by sequence number. When a buffer is no longer in use, it may be recycled (e.g., an object may try to give it to itself or release it to the buffer manager for later reallocation). Thus, data generally does not need to be copied; routing simply overwrites the buffer owner bytes.

[0067] Such an implementation of PCGP may provide a variety of benefits, examples of which may include, but are not limited to: Once a message is in the buffer, it may not be possible to withdraw the message due to lack of buffering, as the message may remain there until it is forwarded or received by an application. Offsets are used to access the driver, PCGP, and payload sections of the buffer, so data does not have to be copied. A driver may swap ownership of message data by overwriting one byte (i.e., the buffer ownership byte). Reentrant, since a mutex may only be needed when a single buffer owner wants to use the buffer concurrently or obtain a new sequence number. There may be no need for multiple exclusions except calls. · Application writers have fewer rules to follow to implement reliable systems. There is a set of calls provided to push / pull data from the driver out of the buffer management system, so drivers may use ISR / push / pull / and polled data models. The driver may not have to do much work beyond TX and RX, as the driver may not have to do any copying, CRC or any checking, but the destination byte and CRC and other checks may be done later from the ISR hotpath. · Queue ordering may occur automatically, since the buffer manager may order accesses by sequence number. Small code / variable footprint may be utilized. Hot path code may be small and overhead may be low.

[0068] As shown in Figure 11F, when a message needs to be sent, PCGP may quickly construct a packet and insert it into the buffer management system. Once in the buffer management system, a call to a "packet processor" may provide the protocol rules and give the message to the driver / application.

[0069] To send a new message or send a reply, the PCGP may: Check the call arguments, for example to make sure the packet length is legal, the destination is correct, etc. Downlinks may allow PCGP to be used by the radio processor to establish links, pairs, etc., and may notify applications when PCGP is attempting to communicate over a link that is not functioning (instead of timing out), avoiding attempting to send messages over a link that is down unless it is a radio link. Get a sequence number for a new message or use an existing sequence number for an existing message. Construct a packet, copy the payload, write in the CRC, and (from this point on) the integrity of the packet may be protected by the CRC. Give a message to the buffer manager, either as a reply or a new message, and check whether putting this buffer in the buffer manager would exceed the maximum number of messages waiting to be sent.

[0070] Referring also to Figures 11G-11H, PCGP may operate by doing all of the major work in one thread to avoid mutexes and to avoid doing a lot of work on send / reply or driver calls. A "packet processor" call may be required to apply protocol rules to reply, new send, and receive messages. Reply messages may simply be sent, but new and receive messages may have rules for sending the message. In each case, the software may loop while waiting for the correct type of message to apply the protocol rules until no more packets can be processed.

[0071] Sending a new message may follow the following rules: Only two messages may be allowed "on the fly" on the network. Enough data about the message may be stored upon activation to match responses and handle timeouts.

[0072] Receiving a message may follow the following rules: A matching response may remove the "when active" information slot so a new packet can be sent. Non-matching responses may be withdrawn. · The new message may be for a protocol (e.g., get / clear network statistics for this node). To receive messages, a buffer may be given to the application or a callback may be used. The buffer may be freed or remain owned by the application.

[0073] Thus, PCGP may be configured as follows: The callback function may copy the payload data out or may use it entirely before returning. · The callback function may own the buffer, reference the buffer and the buffer's payload by the payload address, and the message may be processed at a later time. · The application may poll the PCGP system for received messages. Applications may use callbacks to set events and then poll for incoming messages.

[0074] A communication system may have a limited number of buffers. If a 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, an application may attempt to take one or more steps, examples of which may include, but are not limited to, the following: a) Applications should keep PCGP up to date with radio conditions. Specifically, if a link goes down and PCGP does not know, PCGP may accept and queue new messages to send (or may not optimally time out messages), which may clog the send queue and delay applications from optimally using the link. b) Applications should call "decrement timeout" periodically, ideally every 20-100 milliseconds unless the processor is paused. Generally, messages move fast (a few milliseconds), slow (a few seconds), or not at all. The timeout is an attempt to remove "on-the-fly" messages that should be withdrawn to free up buffers and bandwidth. Doing this infrequently can cause delays when new messages are sent or when the application queues new messages. c) Applications should ask the PCGP if there is pending work to do before pausing. If there is nothing for the PCGP to do, driver activity may wake the system, so the PCGP then does not need to make calls to the "Packet Processor" or "Decrement Timeout" until a new packet enters the system. Failure to do this may result in a timeout condition causing messages that would have been sent / transmitted / received successfully to be withdrawn. d) Applications should not hold on to received messages indefinitely. Message systems depend on quick replies. If applications share PCGP buffers, holding on to a message means holding on to the PCGP buffer. The receiving node does not know whether 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. e) Applications should call the "Packet Processor" frequently. Calls may cause new messages queued by the application to be sent, or may handle the receipt of new messages. Calls may also cause buffers to be reallocated, and infrequent calls may slow message traffic.

[0075] As shown in Figure 11I, at some point the RX driver may be asked to receive a message from the other side of the interface. To ensure that the message is not discarded, the RX driver may ask the buffer manager if there is a buffer available to store the new message. The driver may then ask for a buffer pointer and begin filling the buffer with the received data. Once the complete message is received, the RX driver may call a function to send the packet. The route function may inspect the destination byte in the packet header and change the owner to another driver or application, or may detect that the packet is bad and discard the packet by releasing the buffer.

[0076] The PCGP RX overhead may consist of asking for the next available buffer and calling a route function. An example of code that performs such a function is as follows:

[0077] [ka] The driver may perform a TX by asking the buffer manager for a pointer to the next buffer to send. The TX driver may then ask the other side of the interface if it can accept the packet. If the other side rejects the packet, the TX driver may do nothing with the buffer since its state has not changed. Otherwise, the driver may send the packet and recycle / free the buffer. An example of code that performs such a function is as follows:

[0078] [ka] To avoid transmitting packets that exceed the maximum message system timeout period, the buffer to be freed may be scanned for the next buffer. BufferManager::First(Unit8 Owner). Thus, a full TX buffer that has no desire to time out may be freed on the thread that owns the buffer. A bridge that is doing TX (i.e., looking for the next TX buffer) may free all of the TX buffers that expire before receiving the next TX buffer for processing.

[0079] As shown in Figures 11J-11L, during the buffer allocation process, buffers marked as available may be transferred to the driver to receive new packets or to PCGP to receive new payloads for TX. Allocation from "available" may be done by the "packet processor" function. The number of sends and receives during the "packet processor" call may determine how many LT_Driver_RX, GT_Driver_RX, and PCGP_Free buffers need to be allocated. LT_Driver may represent a driver that handles addresses that are less than node addresses. GT_Driver may represent a driver that handles addresses that are more than node addresses.

[0080] When a driver receives a packet, it may place the data in an RX buffer that is passed to the router. The router may then reallocate the buffer to PCGP_Receive or to the TX (not shown) of another driver. If the buffer contains apparently invalid data, the buffer may transition to the available state.

[0081] After the router marks the buffer for TX, the driver may discover that the buffer is a TX and may send the message. After sending the message, if the driver is short of RX buffers, the buffer may immediately become an RX buffer, or the buffer may be freed for reallocation.

[0082] During the "Packet Processor" call, PCGP may process all buffers that the router has marked as PCGP_Receive. At this point, CRCs and other data items may be checked as the data may be acted upon. If the data is corrupted, 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.

[0083] When an application wants to send a new message, this may be done in a reentrant, transparent / mutex manner. When a buffer may be allocated, PCGP may mark the buffer as in use. Once marked in use, no other thread calling the send or reply function may grab this buffer, since it is owned by the invocation of the function call. The remainder of the process of error checking and message creation may be done outside of the isolated race condition mutex protection code. The buffer may transition to a usable state, or it may become a valid filled, CRC-checked buffer and be passed to the router. These buffers may not be sent immediately, but may be queued to allow the message to be sent later (assuming protocol rules allow). Reply messages may be marked differently from new send messages, since they may be sent with a higher priority than normal send messages, and there may be no rules limiting how many / when reply messages can be sent.

[0084] PCGP is designed to work with flow control and buffering on the other side of the interface. Flow control may negotiate the transfer of messages from one node to another so that buffers are never retracted due to lack of buffers (which may cause backpressure on the sending node).

[0085] 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. Two bytes may be used: one byte is the DMA length - 1, and the second byte controls the message flow. These same two bytes may synchronize bytes when PCGP messages are transmitted over RS232.

[0086] When a packet is "in flight", it may be in the process of being sent by a driver on its way to its destination, being processed by a destination, or being sent back as a response.

[0087] Typical delays are as follows:

[0088] [Table 1] Thus, messages tend to complete the round trip quickly (e.g., <50 ms), slowly (e.g., 1 second or more), or not at all.

[0089] PCGP may use two different times (set at initialization) for all timeouts: one for when the RF link is in fast heartbeat mode and one for when the RF link is in slow mode. If a message is active 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. Any additional transitions back and forth must not affect the expiration time for the message.

[0090] There is a second timeout, which may be twice as long as the slow timeout, that is used to monitor buffer allocation within PCGP. Thus, if a message is "stranded" in the driver and not sent, for example due to flow control or hardware corruption, the buffer may be freed by the buffer manager, causing it to be withdrawn. For a "new" message, this may mean that the packet has already timed out and a reply has already been given to the application that the message was not delivered. The next time the driver polls the buffer manager for buffers that need to be sent, the buffer is freed so that a message that can be sent can be passed to the driver the next time the blockage is removed. For reply messages, the reply may simply be withdrawn and the sending node may time out.

[0091] A PCGP messaging system may pass messages containing header information and a payload. Outside of PCGP, the header may be a set of data items in a call signature. However, inside PCGP, there may be a consistent, driver-friendly byte layout. Drivers may insert bytes into or before a PCGP packet as follows: ·DE, CA: Synchronization bytes for use with RS232, nominal values ​​0xDE, 0xCA or 0x5A, 0xA5. · LD: Driver DMA length in bytes, equal to the amount the driver is pushing out in this DMA transfer, which is the total size not including the size byte or sync byte. · Cmd: Driver command and control bytes used for flow control. LP: PCGP packet length, always 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 is application-defined and has no significance to PCGP. It allows an application to attach more information to a message, such as the thread from which the message originated. SeqNum: A 32-bit sequence number 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 of PCGP header and payload.

[0092] An example of a message with no payload, cmd=1, subcmd=2 is: 0xDE, 0xCA, 0xC, 0x5, 0x14, 1, 2, 0, 0, 0, 0, 0x1, crchigh, crclow. 0x0D, cmd, 0xC, 0x5, 0x14, 1, 2, 0, 0, 0, 0, 0x1, crchigh, crclow.

[0093] This methodology may have several advantages, examples of which may include, but are not limited to: Most of our hardware DMA engines may use the first byte to specify how many additional bytes to move, so 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. Because the driver length and "Cmd" bytes may be outside the CRC field, they may be modified by the driver, may be owned by the driver transport mechanism, and the driver may guard against invalid lengths. There may be a separate PGCP packet length byte that is CRC protected, so applications may trust that their payload length is correct. The endianness of the sequence number may be irrelevant, as it may be any byte pattern that may be matched, which also happens to be a 32-bit integer. The sequence number may be four bytes, aligned to the edge of the shared buffer pool length. There may be an optional RS232 sync byte so that the user may move the cable around while debugging the message stream and have both sides of the interface resynchronize. Applications, drivers, and PCGPs may share buffers and free them by pointer.

[0094] 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 conceptually exchanged between classes (as shown in Figures 11M-11N).

[0095] Some event models in a driver may wake up the driver, receive a message, and pass the message through the bridge into the buffer manager, which sends the message to the new owner of the new message (through the bridge to the driver or PCGP).

[0096] The following summarizes some exemplary events:

[0097] [Table 2] The following exemplary embodiment shows how the PCGP event model may work with Nucleus to wake up a PCGP task after decTimeout for all sent messages, replies, or NACKs generated.

[0098] [ka] Below is an event-based pseudocode driver that illustrates how the driver events work: The driver subclassifies the bridge, disables send message presence and flow control stop, and schedules the TX and RX functions to be active if they are not already active.

[0099] [ka]

[0100] The following statistics may be supported by PCGP: Number of packets sent Number of packets received CRC error ·timeout - Unavailable buffer (buffer is gone)

[0101] PCGP may be designed to operate in multiple processing environments. Most parameters may be run-time configurable to facilitate testing and run-time fine-tuning of performance. Other parameters may be compile-time, for example anything that modifies memory allocation that must be done statically at compile time.

[0102] The following may be a definition of a number of compile-time configurations that may vary where PCGP is implemented. Driver Bytes: May be two bytes reserved for a common buffer scheme for drivers, but this may be a compile time option to accommodate other drivers such as RF protocols. Number of RX driver buffers: May be tuned to how many buffers are good for that processor / traffic flow etc. · Number of PCGP RX buffers: May be tuned to how many buffers are good for that processor / traffic flow etc. Total number of buffers: May be tuned for how many buffers there should be in that processor.

[0103] The CRC may be used to ensure data integrity. If the CRC is invalid, it may not be delivered to the application and the CRC error may be tracked. The message may eventually time out or be retried by the originator.

[0104] Similarly, if the messaging system informs an application that a message was delivered when it was not, this can be dangerous to the system. A bolus stop command is an example of such a command. This may be mitigated by a request / action sequence of messages that may be required by the application to change therapy. The controller may receive a matching command from the pump application to consider the message delivered.

[0105] DEKA may provide a reference method for interfacing PCGP to a Nucleus OS system on ARM 9 (as shown in Figure 11O).

[0106] 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 "C" code as the objects being acted upon are implicit.

[0107] The following general rules may apply: PCGP may run on all nodes. Any driver may support the generic driver interface. Race conditions must not be tolerated. · Half-duplex may be supported on the SPI port between the slave and master processors. · No data transfer may be attempted, either to succeed or to return failure / false. · May require low overhead (wasted time, processing, bandwidth). May support CC2510 running at DMA (high speed) SPI clock speed.

[0108] SPI flow control may prevent data from being sent if the receiver does not currently have an empty buffer into which to place the packet. This may be accomplished by asking for permission to send and waiting for a response indicating that permission to do so has been granted. There may also be a way to tell the other side that there are currently no free buffers and that the transfer should be attempted later.

[0109] All transmissions may begin with a length byte indicating the number of bytes being sent, not including the length byte itself. Following the length may be a single byte indicating the command being sent.

[0110] The actual transmission of a packet may be the length of the packet plus one for a command byte, followed by a command byte for any attached messages, and finally the packet itself.

[0111] In addition to the command byte being sent, an additional hardware line called a flow control line may be added to the four traditional SPI signals. The purpose of this line is to allow the protocol to operate as quickly as possible without any pre-set delays. It also allows the slave processor to tell the master processor that there are packets waiting to be sent, thus eliminating the need for the master processor to poll the slave processor for status.

[0112] The following example command values ​​may be used:

[0113] [Table 3]

[0114] [Table 4] As shown in Figure 11Q, when a slave processor has a packet to send to the master processor, the slave processor may notify the master processor (by asserting the flow control line) that there is a pending packet 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. Retrieval of the packet may be delayed at the discretion of the master processor, or the master processor may decide to attempt to send the packet to the slave processor before retrieving it from the slave processor.

[0115] The master processor may initiate a recall by sending the slave processor an M_CTS command, which may 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 cleared after the packet is sent. If an M_CTS command is received by a slave processor at an unexpected time, the M_CTS command may be ignored.

[0116] As shown in Figure 11R, when a master processor has a packet to send to a slave processor, it may initiate the transfer by sending an M_RTS command. Upon receiving the M_RTS command, if the slave processor currently has a pending transmit packet, the slave processor lowers the flow control line so that it may be reused as a send authorization signal. The slave processor may then tell the master processor that it is in the process of preparing its SPI DMA to receive a packet, during which time the master processor may stop timing bytes on the bus and allow the slave processor to finish preparing to receive.

[0117] The slave processor may then indicate its readiness to receive the entire packet by raising the flow control line (used as a CTS signal). Upon receiving the CTS signal, the master processor may then send an M_MSG_APPENDED command along with the packet itself.

[0118] After the transfer is complete, the slave processor may lower the flow control line. If a packet was pending at the start of the transfer or a transmission occurred on the slave processor while a packet was being received, the slave processor may reassert the flow control line indicating that there is a packet pending.

[0119] 11A, infusion pump assembly 100, 100' may include switch assembly 318 coupled to electrical control assembly 110 (FIG. 3) that may enable a user (not shown) to perform at least one task, and in some embodiments, multiple tasks. One illustrative example of such a task is administering a bolus dose of an infusible fluid (e.g., insulin) without using a display assembly. Remote control assembly 300 may allow a user to enable / disable / configure infusion pump assembly 100, 100' to administer a bolus dose of insulin.

[0120] 12A , slider assembly 306 may be configured, at least in part, to allow a user to manipulate menu-based information presented on display assembly 302. An example of slider assembly 306 may include a volumetric slider assembly that may be implemented using a CY8C21434-24LFXI PSOC from Cypress Semiconductor (San Jose, California), the operational design of which is described in the Cypress Semiconductor publication "CSD User Module." For example, via slider assembly 306, a user may slide their finger in the direction of arrow 314 to cause a highlighted portion of information contained within main menu 350 (shown in FIG. 12A ) presented on display assembly 302 to scroll upward. Alternatively, a user may slide their finger in the direction of arrow 316 to cause a highlighted portion of information contained within main menu 350 presented on display assembly 302 to scroll downward.

[0121] Slider assembly 306 may be configured to vary the speed at which a highlighted portion of main menu 350 scrolls "up" or "down," for example, depending on the displacement of the user's finger relative to origin 320. Thus, if a user desires to scroll "up" quickly, the user may move the slider assembly 306 to the top of the slider assembly 306. The user may position their finger near the origin 320. Similarly, if the user wishes to scroll "down" quickly, the user may position their finger near the bottom of the slider assembly 306. Additionally, if the user wishes to scroll "up" slowly, the user may position their finger slightly "up" relative to the origin 320. Furthermore, if the user wishes to scroll "down" slowly, the user may position their finger slightly "down" relative to the origin 320. Once the appropriate menu item is highlighted, the user may select the highlighted menu item via one or more switch assemblies 308, 310.

[0122] 12B-12F, assume for illustrative purposes that infusion pump assembly 100, 100′ is an insulin pump and that a user desires to configure infusion pump assembly 100, 100′ so that a 0.20 unit bolus dose of insulin is administered when switch assembly 318 is pressed by the user. Accordingly, the user may use slider assembly 306 to highlight “Bolus” within main menu 350 presented on display assembly 302. The user may then use switch assembly 308 to select “Bolus.” Once selected, processing logic (not shown) within remote control assembly 300 may present submenu 352 on display assembly 302 (as shown in FIG. 12B).

[0123] The user may then use slider assembly 306 to highlight "Manual Bolus" in submenu 352, which may be selected using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then present submenu 354 on display assembly 302 (as shown in FIG. 12C).

[0124] The user may then use slider assembly 306 to highlight "Bolus: 0.0 units" in submenu 354, which may be selected using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then render submenu 356 on display assembly 302 (as shown in FIG. 12D).

[0125] The user may then use slider assembly 306 to adjust the "bolus" insulin amount to "0.2 units," which may be selected using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then render submenu 358 on display assembly 302 (as shown in FIG. 12E).

[0126] User 14 may then use slider assembly 306 to highlight "Confirm," which may be selected using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then generate an appropriate signal, which may be sent to the above-mentioned telemetry circuitry (not shown) contained within remote control assembly 300. The above-mentioned telemetry circuitry (not shown) contained within remote control assembly 300 may then transmit, via wireless communication channel 312 established between remote control assembly 300 and infusion pump assembly 100', an appropriate configuration command to configure infusion pump assembly 100' to administer a 0.20 unit bolus dose of insulin whenever switch assembly 318 is pressed by the user.

[0127] Once the appropriate command has been successfully transmitted, processing logic (not shown) within remote control assembly 300 may once again render submenu 350 on display assembly 302 (as shown in FIG. 12F).

[0128] Specifically, once programmed via remote control assembly 300, a user may press switch assembly 318 of infusion pump assembly 100' to administer the 0.20 unit bolus dose of insulin described above. Through the menu system contained within remote control assembly 300 described above, a user may define the amount of insulin to be administered each time the user presses switch assembly 318. While this specific example specifies that one press of switch assembly 318 is equivalent to 0.20 units of insulin, other values ​​(e.g., 1.00 units of insulin per press) are equally applicable, and are therefore for illustrative purposes only and are not intended to be a limitation of the present disclosure.

[0129] Assume for illustrative purposes that a user desires to administer a 2.00 unit bolus dose of insulin. To activate the bolus dose administration system, the user may need to press and hold switch assembly 318 for a defined period of time (e.g., 5 seconds), at which point infusion pump assembly 100, 100' may generate an audible signal indicating to the user that infusion pump assembly 100, 100' is ready to administer a bolus dose of insulin via switch assembly 318. Thus, the user may press switch assembly 318 ten times (i.e., 2.00 units is ten 0.20 unit doses). After each press of switch assembly 318, infusion pump assembly 100, 100' may provide an audible response to the user via an internal speaker / sound generator (not shown). Thus, the user may initially press switch assembly 318, and infusion pump assembly 100, 100' may, in response, issue a confirmatory beep, thus indicating to the user that infusion pump assembly 100, 100' has received a command for 0.20 units of insulin (in this specific example). Because the desired bolus dose is 2.00 units of insulin, the user may repeat this procedure nine more times to achieve the 2.00 unit bolus dose, with infusion pump assembly 100, 100' issuing a confirmatory beep after each press of switch assembly 318.

[0130] Although in this specific example, infusion pump assembly 100, 100' is described as providing one beep after each time a user presses switch assembly 318, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure. Specifically, infusion pump assembly 100, 100' may be configured to provide a single beep for each prescribed dose of insulin. As discussed above, one press of switch assembly 318 may be equivalent to 0.20 units of insulin. Thus, infusion pump assembly 100, 100' may be configured to provide a single beep for each 0.10 units of insulin. Thus, if infusion pump assembly 100, 100' is configured such that one press of switch assembly 318 is equivalent to 0.20 units of insulin, infusion pump assembly 100, 100' may provide two beeps to the user each time switch assembly 318 is pressed (i.e., one for each 0.10 units of insulin).

[0131] Once the user has pressed switch assembly 318 on infusion pump assembly 100′ a total of 10 times, the user may simply wait for infusion pump assembly 100, 100′ to acknowledge receipt of a command to administer a 2.00 unit bolus dose of insulin (as opposed to a confirmation beep received with each press of switch assembly 318). Once a defined period of time (e.g., 2 seconds) has elapsed, infusion pump assembly 100, 100′ may provide an audible confirmation to the user regarding the unit amount to be administered via the user-requested bolus insulin dose. For example, if infusion pump assembly 100, 100′ is programmed by the user so that (in this example) one press of switch assembly 318 is equivalent to 0.20 units of insulin, infusion pump assembly 100, 100′ may beep 10 times (i.e., 2.00 units is ten 0.20 beeps). unit dose).

[0132] When providing feedback to the user regarding the amount of units administered via the bolus insulin dose, infusion pump assembly 100, 100' may provide a multi-frequency audible confirmation. For example, continuing with the above example in which ten beeps are provided to the user, 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 infusion pump assembly 100, 100' such that each subsequent beep has a higher frequency (similar to a musical scale) than the preceding beep. Thus, continuing with the above example, infusion pump assembly 100, 100' may emit a 1,000 Hz beep, followed by an 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 an 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, the multi-frequency audible confirmation may utilize a different number of tones with increasing frequency. For example, an embodiment may utilize 20 different tones with increasing frequency. However, the number of tones should not be construed as a limitation of the present disclosure, as the number of tones may vary depending on design criteria and user needs.

[0133] Once infusion pump assembly 100, 100' has completed the rendering of the multi-frequency audible confirmation (i.e., the 10 beeps described above), the user may depress switch assembly 318 within a defined period of time (e.g., 2 seconds) to provide a confirmation signal to infusion pump assembly 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, infusion pump assembly 100, 100' may render the audible sound "confirmation received" and (in this particular embodiment) effect delivery of a 2.00 unit bolus dose of insulin. If infusion pump assembly 100, 100' fails to receive the above confirmation signal, infusion pump assembly 100, 100' may render the audible sound "confirmation failed" and do not effect delivery of the bolus dose of insulin. Thus, if the multi-frequency audible confirmation is not accurate / does not indicate the size of the bolus dose of insulin to be administered, the user may simply not provide said confirmation signal, thereby ceasing delivery of the bolus dose of insulin.

[0134] As discussed above, in one exemplary embodiment of the infusion pump assembly, the infusion pump assembly 100' may be used to communicate with a remote control assembly 300. When such a remote control assembly 300 is utilized, the infusion 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 infusion pump assembly 100' may "ping" the remote control assembly 300 to ensure that the remote control assembly 300 is present and operational. Additionally, the remote control assembly 300 may "ping" the infusion pump assembly 100' to ensure that the infusion pump assembly 100' is still present and operational. If one of the infusion pump assembly 100' and the remote control assembly 300 is unable to establish communication with the other assembly, the assembly that is unable to establish communication may sound a "separation" alarm. For example, assume that the remote control assembly 300 is left in a user's car while the infusion pump assembly 100' is in the user's pocket. Thus, after a prescribed period of time, the infusion pump assembly 100' will begin to sound a "disconnect" alarm and the remote control This may indicate that communication cannot be established with control assembly 300. Using switch assembly 318, the user may acknowledge / silence this "disconnect" alarm.

[0135] Because a user may define and administer bolus insulin doses via switch assembly 318 of infusion pump assembly 100' while remote control assembly 300 is not in communication with infusion pump assembly 100', infusion pump assembly 100' may store information regarding the administered bolus insulin doses in a log file (not shown) stored within infusion pump assembly 100'. This log file (not shown) may be stored in non-volatile memory (not shown) included within infusion pump assembly 100'. When communication is re-established between infusion pump assembly 100' and remote control assembly 300, infusion pump assembly 100' may provide remote control assembly 300 with information regarding the administered bolus insulin doses, which is stored in the log file (not shown) of infusion pump assembly 100'.

[0136] Additionally, when the user anticipates separating remote control assembly 300 from infusion pump assembly 100', the user may configure infusion pump assembly 100' and remote control assembly 300 (via the menu system described above) to enter a "separate" mode, thus eliminating the generation of the "separate" alarm described above. However, the devices may continue to "ping" each other such that infusion pump assembly 100' and remote control assembly 300 may automatically exit "separate" mode upon returning to communication with each other.

[0137] Additionally, if the user anticipates traveling by airplane, the user may configure infusion pump assembly 100' and remote control assembly 300 (via the above-described menu system of remote control assembly 300) to enter an "airplane" mode in which each of infusion pump assembly 100' and remote control assembly 300 suspends any and all data transmission. While in "airplane" mode, infusion pump assembly 100' and remote control assembly 300 may or may not continue to receive data.

[0138] Switch assembly 318 may be used to perform additional functions, such as checking the battery life of reusable housing assembly 102, pairing reusable housing assembly 102 with remote control assembly 300, and pausing the administration of a bolus dose of infusible fluid.

[0139] (Steps to check battery life:) Reusable housing assembly 102 may include a rechargeable battery assembly that may be capable of powering infusion pump assembly 100, 100′ for approximately three days (when fully charged). Such a rechargeable battery assembly may have a predetermined number of usable hours, e.g., a usable life in years, or other predetermined length of use. However, the predetermined life may depend on many factors, including, but not limited to, one or more of climate, daily use, and number of recharges. Whenever reusable housing assembly 102 is disconnected from disposable housing assembly 114, infusion pump assembly 100, 100′ may perform a battery check on the rechargeable battery assembly whenever switch assembly 318 is pressed for a defined period of time (e.g., more than two seconds). If the rechargeable battery assembly is determined to be charged above a desired threshold, infusion pump assembly 100, 100′ may emit a “battery pass” tone. Alternatively, if the rechargeable battery assembly is determined to be charged below a desired threshold, the infusion pump assembly 100, 100' may emit a "low battery" tone. The device may include components and / or circuitry to determine whether the device is disconnected from bridge 114.

[0140] (Pairing steps:) As discussed above, in one exemplary embodiment of the infusion pump assembly, infusion pump assembly 100′ may be used to communicate with remote control assembly 300. To achieve communication between infusion pump assembly 100′ and remote control assembly 300, a pairing process may be performed. During such a pairing process, one or more infusion pump assemblies (e.g., infusion pump assembly 100′) may be configured to communicate with remote control assembly 300, and (conversely), remote control assembly 300 may be configured to communicate with one or more infusion pump assemblies (e.g., infusion pump assembly 100′). Specifically, the serial number of the infusion pump assembly (e.g., infusion pump assembly 100′) may be recorded in a pairing file (not shown) included within remote control assembly 300, and the serial number of the remote control assembly 300 may be recorded in a pairing file (not shown) included within the infusion pump assembly (e.g., infusion pump assembly 100′).

[0141] According to embodiments, to accomplish such a pairing procedure, a user may simultaneously press one or more switches on both remote control assembly 300 and infusion pump assembly 100'. For example, a user may simultaneously press switch assembly 310 included in remote control assembly 300 and switch assembly 318 included in infusion pump assembly 100' for a defined period of time, e.g., greater than five seconds. Once this defined period is reached, one or more of remote control assembly 300 and infusion pump assembly 100' may generate an audible signal indicating that the above-described pairing procedure has been accomplished.

[0142] According to another embodiment, before performing the pairing process, the user may detach the reusable housing assembly 102 from the disposable housing assembly 114. Requiring this initial step provides additional assurance that the infusion pump assembly worn by the user should not be surreptitiously paired with the remote control assembly.

[0143] Once disconnected, the user may enter pairing mode via input assembly 304 of remote control assembly 300. For example, the user may enter pairing mode on remote control assembly 300 via, for example, the menu system described above in combination with switch assembly 310. The user may be instructed on display assembly 302 of remote control assembly 300 to press and hold switch assembly 318 on infusion pump assembly 100'. In addition, remote control assembly 304 may switch to a low-power mode, for example, to avoid attempting to pair with a remote infusion pump assembly. The user may then press and hold switch assembly 318 on infusion pump assembly 100' to cause infusion pump assembly 100' to enter receive mode and await a pairing command from remote control assembly 300.

[0144] Remote control assembly 300 may then transmit a pairing request to infusion pump assembly 100', which may be acknowledged by infusion pump assembly 100'. Infusion pump assembly 100' may perform a security check on the pairing request received from remote control assembly 300, and (if the security check passes) infusion pump assembly 100' may activate a pump pairing signal (i.e., enter active pairing mode). Remote control assembly 300 may also perform a security check on the acknowledgement received from infusion pump assembly 100'.

[0145] The acknowledgement received from infusion pump assembly 100′ may specify the serial number of infusion pump assembly 100′, and remote control assembly 300 may display the serial number on display assembly 302 on remote control assembly 300. The user may be asked whether they wish to pair with the found pump. If the user declines, the pairing process may be aborted. If the user agrees to the pairing process, remote control assembly 300 may prompt the user (via display assembly 302) to press and hold switch assembly 318 on infusion pump assembly 100′.

[0146] The user may then depress and hold switch assembly 318 on infusion pump assembly 100 ′ and, for example, depress and hold switch assembly 310 on remote control assembly 300 .

[0147] Remote control assembly 300 may confirm that remote switch assembly 310 has been pressed (which may be reported to infusion pump assembly 100'). Infusion pump assembly 100' may perform a security check on the confirmation received from remote control assembly 300 to verify its integrity. If the integrity of the received confirmation is not verified, the pairing process is aborted. 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, a pump pairing complete signal is activated, and the pairing process is completed.

[0148] Additionally, infusion pump assembly 100' may confirm that switch assembly 318 has been pressed (which may be reported to remote control assembly 300). Remote control assembly 300 may perform a security check on the confirmation received from infusion pump assembly 100' to verify its integrity. If the integrity of the received confirmation is not verified, the pairing process is aborted. If the integrity of the received confirmation is verified, a pair list file in remote control assembly 300 may be modified to add infusion pump assembly 100'. Typically, remote control assembly 300 may be capable of pairing with multiple infusion pump assemblies, while infusion pump assembly 100' may only be capable of pairing with a single remote control assembly. A pairing complete signal may be initiated, completing the pairing process.

[0149] Upon completion of the pairing process, one or more of remote control assembly 300 and infusion pump assembly 100' may generate an audible signal indicating that the above pairing procedure has been successfully accomplished.

[0150] (Steps to interrupt the bolus dose:) If a user desires to, for example, discontinue a bolus dose of insulin being administered by infusion pump assembly 100', the user may depress switch assembly 318 (e.g., shown in FIGS. 1 and 2) for a defined period of time, for example, greater than 5 seconds. Once this defined period of time is reached, infusion pump assembly 100' may emit an audible signal indicating that the discontinuation procedure described above has been accomplished.

[0151] Although switch assembly 318 is shown as being located on the top of infusion pump assembly 100, 100', this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other configurations are possible. For example, switch assembly 318 may be located on the periphery of infusion pump assembly 100, 100'.

[0152] 13-15, there is shown an alternative embodiment infusion pump assembly 400. Similar to pump assemblies 100, 100′, infusion pump assembly 400 may include a reusable housing assembly 402 and a disposable housing assembly 404.

[0153] Similar to reusable housing assembly 102, reusable housing assembly 402 may include a mechanical control assembly (including at least one pump assembly and at least one valve assembly). Reusable housing assembly 402 may also include an electrical control assembly configured to provide control signals to the mechanical control assembly to effect delivery of the infusible fluid to a user. The valve assemblies may be configured to control the flow rate of the infusible fluid through the fluid pathways, and the pump assemblies may be configured to pump the infusible fluid from the fluid pathways to a user.

[0154] Similar to disposable housing assembly 114, disposable housing assembly 404 may be configured for a single use or for use for a specified period of time, such as, for example, three days or any other amount of time. Disposable housing assembly 404 may be configured such that any components in infusion pump assembly 400 that come into contact with the infusible fluid are disposed on and / or inside disposable housing assembly 404.

[0155] In certain embodiments of this infusion pump assembly, infusion pump assembly 400 may include a switch assembly 406 positioned around the periphery of infusion pump assembly 400. For example, switch assembly 406 may be positioned along a radial edge of infusion pump assembly 400, which may allow for easier use by a user. Switch assembly 406 may be covered with a waterproof membrane configured to prevent water infiltration into infusion pump assembly 400. Reusable housing assembly 402 may include a main body 408 (enclosing the mechanical and electrical control assemblies described above) and a locking ring assembly 410, which may be configured to rotate around main body 408 (in the direction of arrow 412).

[0156] Similar to reusable housing assembly 102 and disposable housing assembly 114, reusable housing assembly 402 may be configured to releasably engage disposable housing assembly 404. Such releasable engagement may be achieved, for example, by a threaded, twist-lock, or compression-fit arrangement. In embodiments in which a twist-lock configuration is utilized, a user of infusion pump assembly 400 may first properly position reusable housing assembly 402 relative to disposable housing assembly 404 and then rotate locking ring assembly 410 (in the direction of arrow 412) to releasably engage reusable housing assembly 402 with disposable housing assembly 404.

[0157] Through the use of 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. Thus, the reusable housing assembly 402 may be properly aligned with the disposable housing assembly 404 prior to engagement, and such alignment must not be disturbed during the engagement process. The locking ring assembly 410 may include a latching mechanism (not shown) that may prevent rotation of the locking ring assembly 410 until the reusable housing assembly 402 and the disposable housing assembly 404 are properly positioned relative to one another.

[0158] 16-18, an alternative embodiment infusion pump assembly 500 is shown. Similar to pump assemblies 100, 100', infusion pump assembly 500 is It may include a usable housing assembly 502 and a disposable housing assembly 504 .

[0159] Similar to reusable housing assembly 402, reusable housing assembly 502 may include a mechanical control assembly (including at least one pump assembly and at least one valve assembly). Reusable housing assembly 502 may also include an electrical control assembly configured to provide control signals to the mechanical control assembly to effect delivery of the infusible fluid to a user. The valve assemblies may be configured to control the flow rate of the infusible fluid through the fluid pathways, and the pump assemblies may be configured to pump the infusible fluid from the fluid pathways to a user.

[0160] Similar to disposable housing assembly 404, disposable housing assembly 504 may be configured for a single use or for use for a specified period of time, such as, for example, three days or any other amount of time. Disposable housing assembly 504 may be configured such that any components in infusion pump assembly 500 that come into contact with the infusible fluid are disposed on and / or inside disposable housing assembly 504.

[0161] In certain embodiments of this infusion pump assembly, infusion pump assembly 500 may include a switch assembly 506 positioned on the periphery of infusion pump assembly 500. For example, switch assembly 506 may be positioned along a radial edge of infusion pump assembly 500, which may allow for easier use by a user. Switch assembly 506 may be covered with a waterproof membrane and / or an O-ring, or other sealing mechanism may be included on stalk 507 of switch assembly 506 configured to prevent water infiltration into infusion pump assembly 500. However, in some embodiments, switch assembly 506 may include an overmolded rubber button and thus provide functionality as a waterproof seal without the use of a waterproof membrane or O-ring. However, in still other embodiments, the overmolded rubber button may additionally be covered with a waterproof membrane and / or include an O-ring. Reusable housing assembly 502 may include a main body 508 (which houses the mechanical and electrical control assemblies described above) and a locking ring assembly 510, which may be configured to rotate around main body 508 (in the direction of arrow 512).

[0162] Similar to reusable housing assembly 402 and disposable housing assembly 404, reusable housing assembly 502 may be configured to releasably engage disposable housing assembly 504. Such releasable engagement may be achieved, for example, by a threaded, twist-lock, or compression-fit arrangement. In embodiments in which a twist-lock configuration is utilized, a user of infusion pump assembly 500 may first properly position reusable housing assembly 502 relative to disposable housing assembly 504 and then rotate locking ring assembly 510 (in the direction of arrow 512) to releasably engage reusable housing assembly 502 with disposable housing assembly 404.

[0163] Because locking ring assembly 510 included within infusion pump assembly 500 may be taller than locking ring assembly 410 (i.e., as indicated by arrow 514), locking ring assembly 510 may include a passageway 516 through which button 506 may pass. Thus, when assembling reusable housing assembly 502, locking ring assembly 510 may be installed onto main body 508 (in the direction of arrow 518). Once locking ring assembly 510 is installed onto main body 508, one or more locking tabs (not shown) may prevent locking ring assembly 510 from being removed from main body 508. The portion of switch assembly 506 protruding through passageway 516 may then be pressed into main body 508 (in the direction of arrow 520), thus completing the installation of switch assembly 506.

[0164] Although button 506 is shown in various locations on infusion pump assembly 500, button 506 may be located anywhere desired on infusion pump assembly 500 in other embodiments.

[0165] Through the use of 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. Thus, the reusable housing assembly 502 may be properly aligned with the disposable housing assembly 504 prior to engagement, and such alignment must not be disturbed during the engagement process. The locking ring assembly 510 may include a latching mechanism (not shown) that prevents rotation of the locking ring assembly 510 until the reusable housing assembly 502 and the disposable housing assembly 504 are properly positioned relative to one another. The passageway 516 may be elongated to allow movement of the locking ring 510 around the switch assembly 506.

[0166] 19A-19B and 20-21 , various views of infusion pump assembly 500 are shown, which is shown to include reusable housing assembly 502, switch assembly 506, and main body 508. As discussed above, main body 508 may include multiple components, examples of which include, but are not limited to, volume sensor assembly 148, printed circuit board 600, vibration motor assembly 602, shape memory actuator anchor 604, switch assembly 506, battery 606, antenna assembly 608, pump assembly 106, measurement valve assembly 610, volume sensor valve assembly 612, and reservoir valve assembly 614. For clarity, printed circuit board 600 has been removed from FIG. 19B to allow for visualization of the various components positioned below printed circuit board 600.

[0167] Various electrical components that may be electrically coupled to printed circuit board 600 may include spring-biased terminals that allow for electrical coupling without the need to solder connections. For example, vibration motor assembly 602 may utilize a pair of spring-biased terminals (one positive and one negative) that are configured to bear against corresponding conductive pads on printed circuit board 600 when vibration motor assembly 602 is positioned on printed circuit board 600. However, in an exemplary embodiment, vibration motor assembly 602 is soldered directly to the printed circuit board.

[0168] As discussed above, volume sensor assembly 148 may be configured to monitor the amount of fluid infused by infusion pump assembly 500. For example, volume sensor assembly 148 may be configured as a volume sensor such as that manufactured by DEKA, the entire disclosure of which is incorporated herein by reference. Acoustic volumetric sensing, the subject of U.S. Patent Nos. 5,575,310 and 5,755,683, assigned to U.S. Patent Applications Nos. US 2007 / 0228071 A1, US 2007 / 0219496 A1, 2007 / 0219480 A1, and US 2007 / 0219597 A1, may be employed.

[0169] Vibration motor assembly 602 may be configured to provide a vibration-based signal to a user of infusion pump assembly 500. For example, if the voltage of battery 606 (which powers infusion pump assembly 500) drops below a minimum allowable voltage, vibration motor assembly 602 may vibrate infusion pump assembly 500 to provide a vibration-based signal to a user of infusion pump assembly 500. Shape memory actuator anchor 604 may The shape memory actuator 112 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 rigidly affixed (i.e., secured) 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, by applying electrical energy to the shape memory actuator 112, the length of the shape memory actuator 112 may be controlled, and thus the valve assembly and pump actuator to which it is attached may be operated.

[0170] Antenna assembly 608 may be configured to enable wireless communication, for example, between infusion pump assembly 500 and remote control assembly 300 (FIG. 11). As discussed above, remote control assembly 300 may allow a user to program infusion pump assembly 500, for example, to configure bolus infusion events. As discussed above, infusion pump assembly 500 may include one or more valve assemblies configured to control the flow rate of infusible fluid through a fluid path (within infusion pump assembly 500), and pump assembly 106 may be configured to infuse the infusible fluid from the fluid path to a user. In this particular embodiment of infusion pump assembly 500, infusion pump assembly 500 is shown to include three valve assemblies: a measurement valve assembly 610, a volume sensor valve assembly 612, and a reservoir valve assembly 614.

[0171] As discussed above, and with reference also to FIG. 21 , the infusible fluid may be stored in reservoir 118. To effect delivery of the infusible fluid to a user, processing logic (not shown) included within infusion pump assembly 500 may energize shape memory actuator 112, which may be anchored on one end using shape memory actuator anchor 604. With reference also to FIG. 22A , shape memory actuator 112 may cause actuation of pump assembly 106 and reservoir valve assembly 614. Reservoir valve assembly 614 may include reservoir valve actuator 614A and reservoir valve 614B, and actuation of reservoir valve assembly 614 may cause downward displacement of reservoir valve actuator 614A and closing of reservoir valve 614B, effectively isolating reservoir 118. Further, the pump assembly 106 may include a pump plunger 106A and a pump chamber 106B, and activation of the pump assembly 106 may displace the pump plunger 106A downward into the pump chamber 106B, resulting in displacement of the injectable fluid (in the direction of arrow 616).

[0172] Volume sensor valve assembly 612 may include a volume sensor valve actuator 612A and a volume sensor valve 612B. Referring also to FIG. 22B , volume sensor valve actuator 612A may be closed via a spring assembly that provides a mechanical force to seal volume sensor valve 612B. However, when pump assembly 106 is activated, if the displaced infusible fluid is of sufficient pressure to overcome the mechanical sealing force of volume sensor valve assembly 612, displacement of infusible fluid occurs in the direction of arrow 618. This may result in filling of volume sensor chamber 620 contained within volume sensor assembly 148. Through the use of speaker assembly 622, port assembly 624, reference microphone 626, spring diaphragm 628, and constant volume microphone 630, volume sensor assembly 148 may determine the volume of infusible fluid contained within volume sensor chamber 620.

[0173] 22C , once the volume of infusible fluid contained within volume sensor chamber 620 has been calculated, shape memory actuator 632 may be energized, resulting in actuation of measurement valve assembly 610, which may include measurement valve actuator 610A and measurement valve 610B. Once actuated, and due to the mechanical energy exerted by spring diaphragm 628 on the infusible fluid within volume sensor chamber 620, the infusible fluid within volume sensor chamber 620 may be displaced (in the direction of arrow 634) through disposable cannula 138 and into the user's body.

[0174] 23 , an exploded view of infusion pump assembly 500 is shown. Shape memory actuator 632 may be secured (on a first end) to shape memory actuator anchor 636. Additionally, the other end of shape memory actuator 632 may be used to provide mechanical energy to valve assembly 638, which may actuate measurement valve assembly 610. Volume sensor assembly spring retainer 642 may properly position volume sensor assembly 148 relative to various other components of infusion pump assembly 500. Valve assembly 638 may be used in conjunction with shape memory actuator 112 to actuate pump plunger 106A. Measurement valve 610B, volume sensor valve 612B, and / or reservoir valve 614B may be self-contained valves configured to allow installation during assembly of infusion pump assembly 500 by pressing the valves upwardly against the underside of main body 508.

[0175] 24 and 25A-25D, there is shown 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.

[0176] 26A-26B and 27A-27B, which show more detailed views of measurement valve assembly 610. As discussed above, valve assembly 638 may actuate measurement valve assembly 610.

[0177] 28A-28D , infusion pump assembly 500 may include measurement valve assembly 610. As discussed above, valve assembly 638 may be activated via shape memory actuator 632 and actuator assembly 640. Thus, to infuse a quantity of infusible fluid stored in volume sensor chamber 620, shape memory actuator 632 may need to activate valve assembly 638 for a significant period of time (e.g., one minute or more). Because this consumes a significant amount of power from battery 606, measurement valve assembly 610 may allow for temporary activation of valve assembly 638, at which point measurement valve latch 656 may prevent valve assembly 638 from returning to its unactivated position. Shape memory actuator 652 may be secured on a first end using electrical contact 654. The other end of shape memory actuator 652 may be connected to valve latch 656. When shape memory actuator 652 is activated, shape memory actuator 652 may pull valve latch 656 forward, releasing valve assembly 638. As such, measurement valve assembly 610 may be activated via shape memory actuator 632. Once measurement valve assembly 610 is activated, valve latch 656 may automatically latch valve assembly 638 in the activated position. Activating shape memory actuator 652 may pull valve latch 656 forward, releasing valve assembly 638. Assuming shape memory actuator 632 is no longer activated, measurement valve assembly 610 becomes deactivated once valve latch 656 releases valve assembly 638. Thus, through use of measurement valve assembly 610, shape memory actuator 632 does not need to be activated the entire time it takes to inject the quantity of infusible fluid stored in volume sensor chamber 620.

[0178] As discussed above, the above-described infusion pump assemblies (e.g., infusion pump assemblies 100, 100′, 400, 500) may include an external infusion set 134 configured to deliver an infusible fluid to a user. External infusion set 134 may include a cannula assembly 136, which may include a needle or disposable cannula 138, and a tubing assembly 140. Tubing assembly 140 may be in fluid communication with reservoir 118, e.g., through a fluid pathway, and with cannula assembly 138, e.g., directly or through a cannula interface 142.

[0179] 29 , an alternative embodiment infusion pump assembly 700 configured to store a portion of tubing assembly 140 is shown. Specifically, infusion pump assembly 700 may include a peripheral tubing containment assembly 702 configured to allow a user to wrap a portion of tubing assembly 140 around infusion pump assembly 700 (similar to a yo-yo). Peripheral tubing containment assembly 702 may be positioned around infusion pump assembly 700. Peripheral tubing containment assembly 702 may be configured as an open valley into which a portion of tubing assembly 140 may be wrapped. Alternatively, peripheral tubing containment assembly 702 may include one or more divided portions 704, 706 forming multiple narrower valleys, which may be sized to create an interference fit between the walls of the narrower valleys and the outer surface of the portion of tubing 140. When peripheral tubing containment assembly 705 includes multiple split sections 704, 706, the resulting narrower valleys may be wrapped in a spiral fashion around the infusion pump assembly 700 (similar to the threads of a screw).

[0180] 30-31 , an alternative embodiment infusion pump assembly 750 configured to store a portion of tubing assembly 140 is shown. Specifically, infusion pump assembly 750 may include a peripheral tubing containment assembly 752 configured to allow a user to wrap a portion of tubing assembly 140 around infusion pump assembly 750 (again, similar to a yo-yo). Peripheral tubing containment assembly 752 may be positioned around infusion pump assembly 750. Peripheral tubing containment assembly 752 may be configured as an open valley into which a portion of tubing assembly 140 may be wrapped. Alternatively, peripheral tubing containment assembly 752 may include one or more divided portions 754, 756 forming multiple narrower valleys, which may be sized to create an interference fit between the walls of the narrower valleys and the outer surface of the portion of tubing 140. When the peripheral tubing containment assembly 752 includes multiple segments 754, 756, the resulting narrower valley may be wrapped in a spiral fashion around the infusion pump assembly 750 (again, similar to the threads of a screw).

[0181] Infusion pump assembly 750 may include a tubing retainer assembly 758. Tubing retainer assembly 758 may be configured to releasably secure tubing assembly 140 to prevent tubing assembly 140 from unraveling from around infusion pump assembly 750. In one embodiment of tubing retainer assembly 758, tubing 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 tubing assembly 140 may be pushed through. Thus, a user may wrap tubing assembly 140 around infusion pump assembly 750, with each loop of tubing assembly 140 secured within peripheral tubing containment assembly 752 via tubing retainer assembly 758. If the user desires to lengthen the unsecured portion of tubing assembly 140, the user may release one loop of tubing assembly 140 from tubing retainer assembly 758. Conversely, if the user desires to shorten the unsecured portion of tubing assembly 140, the user may secure one additional loop of tubing assembly 140 within tubing retainer assembly 758.

[0182] 32-33, there is shown an exemplary embodiment of infusion pump assembly 800. Similar to infusion pump assemblies 100, 100′, 400, and 500, infusion pump assembly 800 may include a reusable housing assembly 802 and a disposable housing assembly 804.

[0183] 34A-34B , similar to infusion pump assembly 100, reusable housing assembly 802 may be configured to releasably engage disposable housing assembly 804. Such releasable engagement may be achieved, for example, by a threaded, twist-lock, or compression-fit arrangement. Infusion pump assembly 800 may include locking ring assembly 806. For example, reusable housing assembly 802 may be properly positioned relative to disposable housing assembly 804, and locking ring assembly 806 may be rotated to releasably engage reusable housing assembly 802 and disposable housing assembly 804.

[0184] Locking ring assembly 806 may include a knot 808, which may facilitate rotation of locking ring assembly 806. Additionally, the position of knot 808, for example, relative to tab 810 of disposable housing assembly 804, may provide verification that reusable housing assembly 802 is fully engaged with disposable housing assembly 804. For example, as shown in FIG. 34A , when reusable housing assembly 802 is properly aligned with disposable housing assembly 804, knot 808 may be aligned in a first position relative to tab 810. Upon achieving full engagement, rotating locking ring assembly 806 may cause knot 808 to be aligned in a second position relative to tab 810, as shown in FIG. 34B .

[0185] 35A-35C and 36-38A, similar to reusable housing assembly 102, reusable housing assembly 802 may include a mechanical control assembly 812 (e.g., which may include valve assembly 814 shown in FIG. 36 including one or more valves and one or more pumps for delivering and controlling the flow rate of the infusible fluid). Reusable housing assembly 802 may also include an electrical control assembly 816 configured to provide control signals to mechanical control assembly 812 to effect delivery of the infusible fluid to a user. Valve assembly 814 may be configured to control the flow rate of the infusible fluid through the fluid pathways, and the pump assembly may be configured to deliver the infusible fluid from the fluid pathways to a user.

[0186] Mechanical control assembly 812 and electrical control assembly 816 may be contained within an enclosure defined by substrate 818 and body 820. In some embodiments, one or more of substrate 818 and 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 electrical control assembly 816. Additionally / alternatively, as shown in FIGS. 36 and 37 , EMI shielding 822 may be included. EMI shielding 822 may provide shielding against generated and / or received electromagnetic interference.

[0187] Reusable housing assembly 802 may include a switch assembly that may be configured to receive user commands (e.g., for bolus delivery, pairing in a remote control assembly, etc.). Switch assembly may include button 824 that may be disposed in opening 826 in body 820. For example, as shown in FIG. 35B , locking ring assembly 806 may be configured to rotate relative to body 820 while still providing easy access to button 824. The axially extending portion 824 may be configured as shown and may include radial slots 828.

[0188] 39A-39C, electrical control assembly 816 may include a printed circuit board 830 and a battery 832. Printed circuit board 830 may include various control electronics for monitoring and controlling the amount of infusible fluid that has been and / or is being pumped. For example, electrical control assembly 816 may measure the amount of infusible fluid just dispensed and determine whether enough infusible fluid has been dispensed based on the dose required by the user. If enough infusible fluid has not been dispensed, electrical control assembly 816 may determine that more infusible fluid should be pumped. Electrical control assembly 816 may provide an appropriate signal to mechanical control assembly 812 so that the additional required dose may be pumped, or electrical control assembly 816 may provide an appropriate signal to mechanical control assembly 812 so that an additional dose may be dispensed with the next dose. Alternatively, if too much infusible fluid is dispensed, the electrical control assembly 816 may provide an appropriate signal to the mechanical control assembly 812 so that less infusible fluid may be dispensed with the next dose. The electrical control assembly 816 may include one or more microprocessors. In an exemplary embodiment, the electrical control assembly 816 may include three processors. One processor (which may include, for example, but is not limited to, a CC2510 microcontroller / RF transceiver available from Chipcon AS (Oslo, Norway)) may be dedicated to wireless communications, for example, to communicate with a remote control assembly. Two additional microprocessors (examples of which may include, but are not limited to, an MSP430 microcontroller available from Texas Instruments Inc. (Dallas, Texas)) may be dedicated to issuing and executing commands (e.g., to dispense doses of infusible fluid, process feedback signals from a volumetric device, etc.).

[0189] 35C, substrate 818 may provide access to electrical contacts 834, which may be electrically coupled to electrical control assembly 816, for example, to recharge battery 832. Substrate 818 may include one or more features (e.g., openings 836, 838) that may be configured to facilitate proper alignment with disposable housing assembly 804 through cooperating features (e.g., tabs) on disposable housing assembly 804. Additionally, as shown in FIGS. 40A-40C, 41A-41B, and 42A-42C, substrate 818 may include various features for mounting valve assembly 814 and electrical control assembly 816, as well as providing access by valve assembly 814 to disposable housing assembly 804.

[0190] The locking ring assembly 806 may include gripping inserts 840, 842, which may include, for example, an elastomer or a textured material, that may 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. Additionally, the locking ring assembly 806 may include a sensing component (e.g., a magnet 844) that may interact with a component (e.g., a Hall Effect sensor) of the reusable housing assembly 802 to provide an indication, for example, of the nature of the mating components (e.g., in some embodiments, which may include, but are not limited to, one or more of the disposable housing assembly 804, the charging station, or the filling station) and / or whether the reusable housing assembly 802 is properly engaged with the mating components. In an exemplary embodiment, the Hall Effect sensor (not shown) may be located on the pump printed circuit board. The Hall Effect sensor may detect when the locking ring has been rotated to the closed position. Thus, the Hall Effect sensor, along with the magnet 844, may provide a system for determining whether the locking ring has been rotated to the closed position.

[0191] The sensing component (magnet) 844, in conjunction with the reusable housing assembly components, i.e., in the exemplary embodiment, a Hall Effect sensor, may operate to provide a determination of whether the reusable housing assembly is properly attached to its intended component or device. The locking ring assembly 806 must not rotate without being attached to a component, i.e., the disposable housing assembly 804, the dust cover, or the charger. Thus, the sensing component, in conjunction with the reusable housing assembly components, may function to provide many advantageous safety features for the infusion pump system. These features may include, but are not limited to, one or more of the following: If the system does not detect that the disposable assembly, dust cover, or charger is not attached, the system may notify, warn, or alert the user because reusable parts, e.g., valves and pump components, may be susceptible to contamination or destruction that could compromise the integrity of the reusable assembly. Thus, the system may provide an integrity alarm to warn the user of a potential reusable assembly integrity threat. Additionally, if the system senses that the reusable assembly is attached to the dust cover, the system may turn off or reduce power to conserve power. This may provide for more efficient use of power when the reusable assembly is not connected to components that it needs to interact with.

[0192] 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 / charging station. In each case, a Hall Effect sensor may detect that the locking ring is in the closed position and, therefore, that the reusable housing assembly 802 is releasably engaged with the disposable housing assembly, the dust cover, or the battery charger / charging station (or another component). The infusion pump system may determine the component to which it is attached by using an AVS system, described in more detail below, or by electrical contacts. Referring now also to FIGS. 38B-38D, one embodiment of a dust cover (e.g., dust cover 839) is shown. In an exemplary 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 the dust cover 839. Additionally, dust cover 839 may further include recessed areas 849 for accommodating valve and pump features of reusable housing assembly 804. For example, with respect to the dust cover, the AVS system may determine that the dust cover is connected to a reusable housing assembly rather than a disposable housing assembly. The AVS system may distinguish between using a lookup table or other comparison data and comparing measurement data to data for a characteristic dust cover or an empty disposable housing assembly. With respect to the battery charger, the battery charger, in an exemplary embodiment, may include electrical contacts. When the reusable housing assembly is attached to the battery charger, the infusion pump assembly electronics system may sense that contact has been made, thus indicating that the reusable housing assembly is attached to the battery charger.

[0193] 43A-45B and 44A-44C, an embodiment of a valve assembly 814 is shown, which may include one or more valves and one or more pumps. Similar to infusion pump assemblies 100, 100', 400, and 500, valve assembly 814 may generally include a reservoir valve 850, a plunger pump 852, a volume sensor valve 854, and a measurement valve 856. As previously described, reservoir valve 850 and plunger pump 852 may be actuated by a shape memory actuator 858, which may be secured (on a first end) to a shape memory actuator anchor 860. Additionally, measurement valve 856 may be actuated by a shape memory actuator 858, which may be secured (on a first end) to a shape memory actuator anchor 866. Measurement valve 856 may be actuated via valve actuator 862 by actuator 864. Similarly, as discussed above, measurement valve 856 may be maintained in an open position via measurement valve latch assembly 868. Measurement valve 856 may be released via activation of shape memory actuator 870, which may be anchored (on a first end) by shape memory actuator anchor 872. In some embodiments, shape memory actuator anchor 860 may be encased in a reusable housing assembly. Using this process during manufacturing ensures that shape memory length actuator 858 is installed and maintains the desired length and tension / strain.

[0194] 45A-45B and 46A-46E, shape memory actuator 858 (which may include, for example, one or more shape memory wires) may actuate plunger pump 852 via actuator assembly 874. Actuator assembly 874 may include biasing spring 876 and lever assembly 878. Actuator assembly 874 may actuate both plunger pump 852 and measurement valve 850.

[0195] 47A-47B, measurement valve 856 may be actuated by shape memory actuator 864 via valve actuator 862 and lever assembly 878. Once actuated, measurement valve latch assembly 868 may maintain measurement valve 856 in the open position. Measurement valve latch assembly 868 is actuated by shape memory actuator 870 to release measurement valve 856, allowing it to return to the closed position.

[0196] Disposable housing assembly 804 may be configured for a single use or for use for a specified period of time, such as, for example, three days or any other amount of time. Disposable housing assembly 804 may be configured such that any components in infusion pump assembly 800 that come into contact with the infusible fluid are disposed on and / or inside disposable housing assembly 804. As such, the risk of contaminating the infusible fluid may be reduced.

[0197] 48 and 49A-49C, the disposable housing assembly 804 may include a base portion 900, a membrane assembly 902, and a top 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 infusible fluid (not shown), e.g., insulin. Referring also to FIGS. 50A-50C, the recess 906 may be at least partially formed by and integral with the base portion 900. The membrane assembly 902 may be sealingly engaged with the base portion 900, for example, by being compressively sandwiched between the base portion 900 and the top portion 904. The top portion 904 may be attached to the base portion 900 by conventional means, such as adhesive, heat sealing, ultrasonic welding, and a compression fit. Additionally / alternatively, the membrane assembly 902 may be attached to the base portion 900 via, for example, adhesive, ultrasonic welding, heat sealing, etc. to provide a seal between the base portion 900 and the membrane assembly 902 .

[0198] 48 and 50A , recess 906 includes a raised portion 901, which in the exemplary embodiment includes a region 903 around fluid opening 905 that leads to a fluid line. Raised portion 901 extends around recess 906 in the exemplary embodiment. However, in other embodiments, raised portion 901 may not extend the entire perimeter, but may be partially around the perimeter. Region 903 around fluid opening 905 may be shaped as shown in the exemplary embodiment, including an angled portion, including a 45-degree angle in some embodiments, although in other embodiments the angle may be greater or less. In some embodiments, the pump may not create enough vacuum to collapse the reservoir to expel the entire volume of fluid that may be stored in the reservoir, and raised portion 901 may act to minimize wasted fluid.

[0199] The fluid openings 905 may be surrounded by a raised region 903, which may include three openings in the exemplary embodiment, although other embodiments may include more or fewer openings. In the exemplary embodiment, the fluid openings 905 may be narrow in the center, thus creating surface tension that may prevent air from being drawn into the openings. In the exemplary 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 being drawn through the fluid opening 905 and into the fluid line. Additionally, there may be more than one fluid opening 905, so that if an air bubble is trapped above one opening, the air may not prevent fluid from flowing through the other two openings.

[0200] 51A-51C , the disposable housing assembly 804 may also include a fluid pathway cover 910. The fluid pathway cover 910 may be received within a cavity 912 formed on / inside the base portion 900. The fluid pathway cover 910, in some embodiments, may include at least a portion of one or more channels (e.g., channel 914). The channels included in the fluid pathway cover 910 may fluidly couple one or more volcano valve features (e.g., volcano valve 916) included on the base portion 900. The volcano valve 916 may include a protrusion having an opening extending therethrough. Additionally, the fluid pathway 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 pathway cover 910, respectively) for fluidly coupling to an infusion set (e.g., including a cannula 922). The cannula 922 may be coupled to the disposable housing assembly 804 by conventional means (e.g., adhesive, heat sealing, compression fit, 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 delivery of the infusible fluid to a user via an infusion 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 exemplary 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 sealing, ultrasonic welding, compression fit, etc.) to achieve a generally fluid-tight seal between the fluid path cover 910 and the base portion 900.

[0201] 54A-54C , the disposable housing assembly 804 may further include a leaflet cover 924. The leaflet cover 924 may be disposed at least partially over a volcano valve (e.g., volcano valve 916) and a pump recess 926 included on / inside the base portion 900. The leaflet cover 924 may comprise a flexible material that may be selectively engaged, for example, to the volcano valve by the reservoir valve 850, the volume sensor valve 854, and the measurement valve 856 of the reusable housing assembly 802 to control, for example, the flow rate of the infusible fluid. Additionally, the leaflet cover 924 may be elastically deformed into the pump recess 926 by the plunger pump 852 to achieve delivery of the infusible fluid. The leaflet cover 924 may be engaged between the base portion 900 and the top portion 904 of the disposable housing assembly 804 to form a seal 928 between the leaflet cover 924 and the base portion 900. For example, in an exemplary embodiment, the leaflet cover 924 may be overmolded onto the base portion 900. In other embodiments, the leaflet cover 924 is compressed and sandwiched between the base portion 900 and the top portion 904 to form a seal 928. Additionally / alternatively, the leaflet insert may be connected to one or more of the base portion 900 and the top portion 904 by, for example, gluing, heat sealing, or the like.

[0202] 53A-C , top portion 904 may include alignment tabs 930, 932 that may be configured to be at least partially received in openings 836, 838 in base plate 818 of reusable housing assembly 802 to ensure proper alignment between reusable housing assembly 802 and disposable housing assembly 804. Additionally, top portion 904 may include one or more radial tabs 934, 936, 938, 940 that are configured to be engaged by cooperating tabs 942, 944, 946, 948 of locking ring assembly 806. One or more radial tabs (e.g., radial tab 940) may include a stop (e.g., a tab that fits into a locating and ultrasonic welding recess that may be used for welding, such as alignment tab stop 950) that may prevent further rotation of locking ring assembly 806 once reusable housing assembly 802 and disposable housing assembly 804 are fully engaged.

[0203] As discussed above, the valve leaflet insert 924 may enable the delivery and flow of infusible fluid by the reservoir valve 850, the plunger pump 852, the volume sensor valve 854, and the measurement valve 856. Accordingly, the top portion 904 may include one or more openings (e.g., openings 952, 954, 956) that may expose at least a portion of the valve leaflet insert 924 for actuation by the reservoir valve 850, the plunger pump 852, the volume sensor valve 854, and the measurement valve 856. Additionally, the top portion 904 may include one or more openings 958, 960, 962 that may be configured to allow the fill volume to be controlled during filling of the reservoir 908, as discussed in more detail below. The reservoir assembly 902 may include ribs 964, 966, 968 (e.g., as shown in FIG. 52A ) that may be at least partially received within each opening 958, 960, 962. As discussed in more detail below, a force may be applied to one or more of the ribs 964, 966, 968 to reduce the volume of the reservoir 908, at least temporarily.

[0204] In some embodiments, it may be desirable to provide a seal between reusable housing assembly 802 and disposable housing assembly 804. Accordingly, disposable housing assembly 804 may include sealing assembly 970. Sealing assembly 970 may include, for example, an elastomeric member that, when engaged, may provide a compressible rubber or plastic layer between reusable housing assembly 802 and disposable housing assembly 804, thus preventing accidental disengagement and penetration by external fluids. For example, sealing assembly 970 may be a watertight assembly, thus allowing a user to wear infusion pump assembly 800 while swimming, bathing, or exercising.

[0205] For example, similar to disposable housing assembly 114, disposable housing assembly 802 may, in some embodiments, be configured to allow reservoir 908 to be filled multiple times. However, in some embodiments, disposable housing assembly 114 may be configured such that reservoir 908 should not be refilled. Referring also to FIGS. 57-64 , fill adapter 1000 may be configured to couple to disposable housing assembly 804 for refilling reservoir 908 using a syringe (not shown). Fill adapter 1000 may include locking tabs 1002, 1004, 1006, 1008, which may be configured to engage radial tabs 934, 936, 938, 940 of disposable housing assembly 804, generally similar to tabs 942, 944, 946, 948 of locking ring assembly 806. Thus, fill adapter 1000 releases locking tabs 1002, 1004, 1006, 1008 by aligning fill adapter 1000 with disposable housing assembly 804 and rotating fill adapter 1000 and disposable housing assembly 804 relative to one another. The disposable housing assembly 804 may be releasably engaged by releasably engaging the radial tabs 934 , 936 , 938 , 940 .

[0206] Fill adapter 1000 may further include a fill aid 1010, which may be, for example, a guide passage 1012 that may be configured to guide the needle of a syringe (not shown) into the septum of disposable housing assembly 804 to allow reservoir 908 of disposable housing assembly 804 to be filled by the syringe. In some embodiments, guide passage 1012 may be an angled or other graduated angled slope to further guide the syringe into the septum. Fill adapter 1000 may facilitate filling reservoir 908, for example, by providing a relatively large insertion area at the distal opening of guide passage 1012. Guide passage 1012 may generally taper to a smaller proximal opening that may be properly aligned with the septum of disposable housing assembly 804 when fill adapter 1000 is engaged with disposable housing assembly 804. Thus, fill adapter 1000 may reduce the dexterity and aiming required to properly insert a needle through the septum of disposable housing assembly 804 for the purpose of filling reservoir 908.

[0207] As discussed above, disposable housing assembly 804 may be configured to facilitate controlling the amount of infusible fluid delivered to reservoir 908 during filling. For example, membrane assembly 902 of disposable housing assembly 804 may include ribs 964, 966, 968 that may be depressed and displaced at least partially into reservoir 908, thereby reducing the volume of reservoir 908. Thus, as infusible fluid is delivered to reservoir 908, the volume of fluid that may be contained by reservoir 908 may be correspondingly reduced. Ribs 964, 966, 968 may be accessible via openings 958, 960, 962 in top portion 904 of disposable housing assembly 804.

[0208] Fill adapter 1000 may include one or more button assemblies (e.g., button assemblies 1014, 1016, 1018) that correspond to ribs 964, 966, 968. That is, when fill adapter 1000 is releasably engaged with disposable housing assembly 804, buttons 1014, 1016, 1018 may be aligned with ribs 964, 966, 968. Button assemblies 1014, 1016, 1018 may, for example, be cantilever members that may be depressed. When fill adapter 1000 is releasably engaged with disposable housing assembly 804, one or more of buttons 1014, 1016, 1018 may be depressed, correspondingly displacing a respective one of ribs 964, 966, 968 into reservoir 908 and causing a concomitant reduction in the volume of reservoir 908.

[0209] For example, for purposes of illustration, assume that reservoir 908 has a maximum volume of 3.00 mL. Assume further that button assembly 1014 is configured to displace rib 964 into disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL volume of disposable housing assembly 804. Assume further that button assembly 1016 is configured to displace rib 966 into disposable housing assembly 804, also resulting in a 0.5 mL reduction in the 3.00 mL volume of disposable housing assembly 804. Assume further that button assembly 1018 is configured to displace slot assembly 968 into disposable housing assembly 804, also resulting in a 0.5 mL reduction in the 3.00 mL volume of disposable housing assembly 804. Thus, if a user desires to fill reservoir 908 in disposable housing assembly 804 with 2.00 mL of infusible fluid, in some embodiments the user may first fill the reservoir to a 3.00 mL volume and then depress button assemblies 1016 and 1014 (disposable housing assembly 804). The disposable housing assembly 804 may be displaced (causing displacement of the rib 966 into the rib 804), effectively reducing the 3.00 mL volume of the reservoir 908 within the disposable housing assembly 804 to 2.00 mL. In some embodiments, a user may first depress a respective number of button assemblies to effectively reduce the volume of the reservoir 908 and then fill the reservoir 908. While a specific number of button assemblies are shown representing the exemplary embodiment, in other embodiments, the number of button assemblies may vary from as few as one to as many as desired. Additionally, for purposes of illustration and in the exemplary embodiment, each button assembly may displace 0.5 mL, although in other embodiments, the volume of displacement per button may vary. Additionally, the reservoir may, in various embodiments, comprise a larger or smaller volume than described in the exemplary embodiment.

[0210] According to the above configuration, button assemblies (e.g., button assemblies 1014, 1016, 1018) may be employed to at least partially fill the volume of reservoir 908. By not pressing any of the button assemblies, a maximum fill volume of reservoir 908 may be achieved. By pressing one button assembly (e.g., button assembly 1014), a second maximum fill volume may be achieved. By pressing two button assemblies (e.g., button assemblies 1014, 1016), a third maximum fill volume may be achieved. By pressing all three button assemblies (e.g., button assemblies 1014, 1016, 1018), a minimum fill volume may be achieved.

[0211] Additionally, in embodiments, button assemblies 1014, 1016, 1018 may be utilized, at least in part, to facilitate filling of reservoir 908. For example, once a fill needle (which may be fluidly coupled, for example, to a vial of injectable fluid) is inserted into reservoir 908, button assemblies 1014, 1016, 1018 may be depressed to expel at least a portion of air that may be contained within the reservoir into the vial of injectable fluid. Button assemblies 1014, 1016, 1018 may later be released to allow injectable fluid to flow from the vial into reservoir 908. Once reservoir 908 is filled with infusible fluid, one or more button assemblies (one or more of button assemblies 1014, 1016, 1018) may be depressed, thereby forcing at least a portion of the infusible fluid out of reservoir 908 (e.g., through a needle used to fill reservoir 908 and back into a vial of infusible fluid). As discussed above, the volume of infusible fluid contained within reservoir 908 may be controlled (e.g., may control how much infusible fluid is forced back into a vial of infusible fluid), for example, depending on how many button assemblies are depressed.

[0212] With particular reference to FIGS. 62-64 , the fill aid 1010 may be pivotally coupled to the fill adapter base 1020. For example, the fill aid 1010 may include pivot members 1022, 1024 that may be configured to be received in pivot supports 1026, 1028, thereby allowing the fill aid to pivot between an open position (e.g., as shown in FIGS. 57-61 ) and a closed position (e.g., as shown in FIGS. 63-64 ). The closed position may be suitable, for example, for packaging the fill adapter 1000, storing the fill adapter 1000, etc. To ensure that the fill aid 1010 is properly oriented for filling the reservoir 908, the fill adapter 1000 may include a support member 1030. To properly orient the fill aid 1010, a user may pivot the fill aid 1010 to the fully open position, and the fill aid 1010 may contact the support member 1030.

[0213] According to an alternative embodiment, and referring also to FIG. 65, a fill adapter 1050 may include a plurality of locking Fill adapter 1050 may be configured to releasably engage disposable housing assembly 804 via tabs (e.g., locking tabs 1052, 1054). Additionally, fill adapter 1050 may include a plurality of button assemblies (e.g., button assemblies 1056, 1058, 1060) that may interact with ribs 964, 966, 968 of disposable housing assembly 804 to adjust the fill volume of reservoir 908. Fill adapter 1050 may further include a fill aid 1062 having a guide passage 1064 configured to align a needle of a syringe with a septum of disposable housing 804, e.g., to access reservoir 908 for purposes of filling reservoir 908 with an infusible fluid. Fill aid 1062 may be connected to substrate 1066, e.g., as an integral component therewith, by adhesive, heat sealing, compression fitting, etc.

[0214] 66-74 , vial fill adapter 1100 may be configured to facilitate filling reservoir 908 of disposable housing assembly 804 directly from a vial. Similar to fill adapter 1000, vial fill adapter 1100 may include locking tabs 1102, 1104, 1106, 1108 that may be configured to engage radial tabs 934, 936, 938, 940 of disposable housing assembly generally similar to tabs 942, 944, 946, 948 of locking ring assembly 806. Thus, vial filling adapter 1100 may be releasably engaged with disposable housing assembly 804 by aligning vial filling adapter 1100 with disposable housing assembly 804 and rotating vial filling adapter 1100 and disposable housing assembly 804 relative to one another to releasably engage locking tabs 1102, 1104, 1106, 1108 with radial tabs 934, 936, 938, 940.

[0215] As discussed above, disposable housing assembly 804 may be configured to facilitate controlling the amount of infusible fluid delivered to reservoir 908 during filling. For example, membrane assembly 902 of disposable housing assembly 804 may include ribs 964, 966, 968 that may be depressed and displaced at least partially into reservoir 908, thereby reducing the volume of reservoir 908. Thus, as infusible fluid is delivered to reservoir 908, the volume of fluid that may be contained by reservoir 908 may be correspondingly reduced. Ribs 964, 966, 968 may be accessible via openings 958, 960, 962 in top portion 904 of disposable housing assembly 804.

[0216] Vial filling adapter 1100 may include one or more button assemblies (e.g., button assemblies 1110, 1112, 1114) that correspond to ribs 964, 966, 968 (as shown in FIG. 52A ). That is, when vial filling adapter 1100 is releasably engaged with disposable housing assembly 804, buttons 1110, 1112, 1114 may be aligned with ribs 964, 966, 968. Button assemblies 1110, 1112, 1114 may, for example, be cantilever members that can be depressed. When vial filling adapter 1100 is releasably engaged with disposable housing assembly 804, one or more of button assemblies 1110, 1112, 1114 may be depressed, correspondingly displacing a respective one of ribs 964, 966, 968 into reservoir 908, thereby reducing the volume of reservoir 908.

[0217] For example, for purposes of illustration, assume that reservoir 908 has a maximum volume of 3.00 mL. Further assume that button assembly 1110 is configured to displace rib 964 into disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL volume of disposable housing assembly 804. Further assume that button assembly 1112 is configured to displace rib 966 into disposable housing assembly 804, also resulting in a 0.5 mL reduction in the 3.00 mL volume of disposable housing assembly 804. Further assume that button Assume assembly 1114 is configured to displace rib 968 into disposable housing assembly 804, also resulting in a 0.5 mL reduction in the 3.00 mL volume of disposable housing assembly 804. Thus, if a user desires to fill reservoir 908 within disposable housing assembly 804 with 2.00 mL of infusible fluid, button assemblies 1112 and 1114 may be depressed (resulting in the displacement of ribs 966 and 968 into disposable housing assembly 804), effectively reducing the 3.00 mL volume of reservoir 908 within disposable housing assembly 804 to 2.00 mL.

[0218] Vial filling adapter 1100 may further include a vial filling aid assembly 1116 that may be configured to fluidly couple a vial of injectable fluid to reservoir 908 of disposable housing assembly 804 via a septum. With particular reference to FIG. 71 , vial filling aid assembly may include a double-ended needle assembly 1118. Double-ended needle assembly 1118 may include a first needle end 1120 configured to pierce a septum of a vial (not shown) and a second needle end 1122 configured to pierce a septum of disposable housing assembly 804. As such, the vial and reservoir 908 may be fluidly coupled, allowing the injectable fluid to be transferred from the vial to reservoir 908. Double-ended needle assembly 1118 may include a vial engaging portion 1124 adjacent first end 1120. The vial engagement arms 1124, 1126 may be configured to releasably engage, for example, a vial cap to assist in maintaining a fluid connection between the double ended needle assembly 1118 and the vial. Additionally, the double ended needle assembly 1118 may include a body 1128 that may be slidably received within an opening 1130 of a vial filling aid body 1132. The vial filling aid body 1132 may include stabilizer arms 1134, 1136 that may be configured, for example, to stabilize the vial during filling of the disposable housing assembly 804. In one embodiment, a vial may be engaged with the double ended needle assembly 1118 such that the first end 1120 may pierce a septum of the vial, and the cap of the vial may be engaged by the engagement 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 may pierce a septum of the disposable body assembly 804.

[0219] Similar to fill adapter 1000, vial filling aid assembly 1116 may be configured to be pivotally coupled to vial filling adapter base plate 1138. For example, vial filling aid 1116 may include pivot members 1140, 1142 that may be configured to be received in pivot supports 1144, 1146 (e.g., shown in FIG. 71 ), thereby allowing vial filling aid 1116 to pivot between an open position (e.g., as shown in FIGS. 66-70 ) and a closed position (e.g., as shown in FIGS. 72-74 ). The closed position may be suitable, for example, for packaging vial filling adapter 1100, storing vial filling adapter 1100, etc. To ensure that vial filling aid 1116 is properly oriented for filling reservoir 908, vial filling adapter 1000 may include support member 1148. To properly orient the vial filling aid 1116, the user may pivot the vial filling aid 1116 to the fully open position, where it may contact the support member 1148. Additionally, the vial filling adapter substrate 1138 may include one or more locking features (e.g., locking tabs 1150, 1152) that may engage the vial filling aid 1116 and maintain the vial filling aid 1116 in the closed position. The vial filling adapter substrate 1138 may also include features (e.g., tabs 1154, 1156) that may be configured to assist in retaining the double-ended needle assembly 1118, for example, by preventing proper separation of the double-ended needle assembly 1118 from the vial filling aid body 1132.

[0220] As shown in Figures 72-74, the filling aid assembly 1116 is in the closed position. In this configuration, the support member 1148 may additionally function as a needle guard. When removing the filling aid assembly 1116 from the body assembly 804, the support member 1148 may function to safely allow the user to squeeze an end and rotate the filling aid assembly 1116 for removal. In the open position, as shown in FIG. 70 , the support member 1148 may function as a stop to maintain proper orientation.

[0221] Referring again to FIGS. 57-73, an exemplary embodiment of the fill adapter includes a gripping feature (e.g., 1166 in FIG. 72). Gripping feature 1166 may provide a gripping interface for removing the fill adapter from disposable housing assembly 804. While shown in one configuration in these figures, in other embodiments, configurations may vary. In still other embodiments, a gripping feature may not be included.

[0222] According to one embodiment, fill adapter substrate 1020 and vial fill adapter substrate 1138 may be interchangeable components. Thus, a single substrate (e.g., either fill adapter substrate 1020 or vial fill adapter substrate 1138) may be used with either fill aid 1010 or vial fill aid 1116. Thus, the number of individual components required for both fill adapters may be reduced, and users may have the ability to select the fill adapter that may be most suitable for a given fill scenario.

[0223] Various embodiments 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 unintentional contact with a needle, i.e., destruction of the integrity of the reservoir through unintentional puncture, being designed to be ambidextrous, and in some embodiments, may provide a system for maintaining air in the reservoir.

[0224] As discussed above, reusable housing assembly 802 may include battery 832, which may include, for example, a rechargeable battery. Referring also to FIGS. 75-80 , battery charger 1200 may be configured to recharge battery 832. Battery charger 1200 may include a housing 1202 having a top plate 1204. Top plate 1204 may include one or more electrical contacts 1206 generally configured to be electrically coupled to electrical contacts 834 of reusable housing assembly 802. Electrical contacts 1206 may include, but are not limited to, electrical contact pads, spring-biased electrical contact members, or the like. Additionally, top plate 1204 may include alignment tabs 1208, 1210, which may be configured to mate with openings 836, 838 in substrate 818 of reusable housing assembly 802 (e.g., as shown in FIG. 35C ). The cooperation of alignment tabs 1208, 1210 and openings 836, 838 may ensure that reusable housing assembly 802 is aligned with battery charger 1200 such that electrical contacts 1206 of battery charger 1200 may electrically couple with electrical contacts 834 of reusable housing assembly 802.

[0225] 77 and 78 , battery charger 1200 may be configured to releasably engage reusable housing assembly 802. For example, similar to disposable housing assembly 804, battery charger 1200 may include one or more locking tabs (e.g., locking tabs 1212, 1214 shown in FIG. 76 ). The locking tabs (e.g., locking tabs 1212, 1214) may be engaged by tabs 942, 944, 946, 948 of locking ring assembly 806. As such, reusable housing assembly 802 may be aligned with battery charger 1200 (via alignment tabs 1208, 1210) with locking ring 806 in a first, unlocked position, as shown in FIG. 77 . The locking ring 806 may be configured to mate with the tabs 942, 944, 946, 948 of the locking ring 806 to the locking tabs (e.g., locking tab 1212, 1214) relative to the battery charger 1200 in the direction of arrow 1216.

[0226] In an embodiment, battery charger 1200 may include recessed area 1218, which may, for example, in an exemplary embodiment, provide clearance to accommodate pump and valve components of reusable housing assembly 802. Referring also to FIGS. 79 and 80 , battery charger 1200 may provide current to electrical contacts 1206 (and thereby to reusable housing assembly 802 via electrical contacts 834) to recharge battery 832 of reusable housing assembly 802. In some embodiments, current may not be provided to electrical contacts 1206 when a signal indicating a fully engaged reusable housing is not provided. According to such an embodiment, risks associated with short circuits (e.g., due to a foreign object contacting electrical contacts 1206) and damage to reusable housing assembly 802 (e.g., due to improper initial alignment between electrical contacts 1206 and electrical contacts 834) may be reduced. Additionally, battery charger 1200 may not unnecessarily draw current when the battery charger is not charging reusable housing assembly 802.

[0227] 79 and 80 , the battery charger 1200 may include a lower housing portion 1224 and a top plate 1204. A printed circuit board 1222 (which may include, for example, electrical contacts 1206) may be disposed within a cavity contained between the top plate 1204 and the lower housing portion 1224.

[0228] 81-89, various embodiments of a battery charger / docking station are shown. FIGS. 81 and 82 show a desktop charger 1250 including a recess 1252 configured to mate with and recharge a reusable housing assembly (e.g., reusable housing assembly 802). The reusable housing assembly may rest within recess 1252 or may be releasably engaged within recess 1252, as discussed above. Additionally, desktop charger 1250 may include a recess 1254 configured to mate with a remote control assembly (e.g., remote control assembly 300). Recess 1254 may include a USB plug 1256, which may be configured to couple with the remote control assembly when the remote control assembly is placed within recess 1254, for example. USB plug 1256 may enable data transfer to / from the remote control assembly as well as charging of the remote control assembly. 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 (e.g., for charging the reusable housing assembly and / or the remote control assembly). Additionally / alternatively, USB port 1258 may be configured for data transfer to / from the remote control assembly and / or the reusable housing assembly, for example, by connection to a computer (not shown).

[0229] 83A-83B , similar to previous embodiments, desktop charger 1260 may include a recess 1262 for mating with a reusable housing assembly (e.g., reusable housing assembly 1264). 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 recesses 1262, 1266 may include electrical and / or data connections configured to charge and / or transfer data to / from reusable housing assembly 1262 and / or remote control assembly 1268, respectively.

[0230] 84A-84B, another embodiment of a desktop charger is shown. Similar to desktop charger 1260, desktop charger 1270 may include recesses (not shown) for mating with reusable housing assembly 1272 and remote control assembly 1274, respectively. As shown, desktop charger 1270 may carry reusable housing assembly 1272 and remote control assembly 1274 in a side-by-side configuration. Desktop charger 1270 may include various electrical and data connections configured to charge and / or transfer data to / from reusable housing assembly 1272 and / or remote control assembly 1274, as described in various embodiments above.

[0231] 85A-85D , foldable charger 1280 may include a recess 1282 for receiving reusable housing assembly 1284 and remote control assembly 1286. Foldable charger 1280 may include various electrical and data connections configured to charge and / or transfer data to / from reusable housing assembly 1284 and / or remote control assembly 1286, as described in various embodiments above. Additionally, as shown in FIGS. 85B-85D , foldable charger 1280 may include a pivotable cover 1288. Pivotable cover 1288 may be configured to pivot between an open position (e.g., as shown in FIG. 85B ), in which reusable housing assembly 1284 and remote control assembly 1286 may be docked to foldable charger 1280, and a closed position (e.g., as shown in FIG. 85D ), in which recess 1282 may be covered by pivotable cover 1288. In the closed position, the recess 1282, and any electrical and / or data connections disposed therein, may be protected from damage.

[0232] 86 , wall charger 1290 may include a recess 1292 configured to receive reusable housing assembly 1294. Additionally, wall charger 1290 may include a recess 1296 configured to receive remote control assembly 1298. Reusable housing assembly 1294 and remote control assembly 1298 may be positioned in a stacked configuration, for example, thereby providing a relatively thin profile. A rear portion of wall charger 1290 may include an electrical plug configured to allow the wall charger to be plugged into an electrical receptacle. As such, wall charger 1290 may achieve a wall-mounted configuration while plugged into the electrical receptacle. Additionally, while plugged into the electrical receptacle, wall charger 1290 may be provided with power to charge reusable housing assembly 1294 and / or remote control assembly 1298.

[0233] 87 , wall charger 1300 may include a recess 1302 configured to receive remote control assembly 1304. Additionally, wall charger may include a recess (not shown) configured to receive reusable housing assembly 1306. Wall charger 1300 may be configured to position remote control assembly 1304 and reusable housing assembly 1306 in an anti-parallel configuration, which may provide a relatively thin profile. Additionally, wall charger 1300 may include an electrical plug 1308 configured to be plugged into an electrical receptacle. Electrical plug 1308 may include a storable configuration, in which electrical plug 1308 may be pivotable between a deployed position (e.g., as shown) and a stowed position. In the deployed position, electrical plug 1308 may be oriented to be plugged into an electrical receptacle. In the stowed position, the electrical plug 1308 may be disposed within a recess 1310, which may protect the electrical plug 1308 from damage and / or from damaging other items.

[0234] 88 , charger 1320 may include a recess 1322 configured to receive reusable housing assembly 1324. Charger 1320 may additionally include a recess (not shown) configured to receive remote control assembly 1326. Charger 1320 may additionally include a cover 1328. Cover 1328 may be configured to pivot between an open position (not shown) and a closed position. Cover 1328 When cover 1324 is in the open position, reusable housing assembly 1324 and remote control assembly 1326 may be accessible (e.g., allowing a user to remove / install reusable housing assembly 1324 and / or remote control assembly 1326 from / into charger 1320). When cover 1324 is in the closed position, cover 1328 and appliance body 1330 may substantially enclose reusable housing assembly 1324 and / or remote control assembly 1326 and / or recess 1322, which is configured to receive remote control assembly 1326, thereby providing damage and / or tamper protection to any electrical and / or data connections associated with reusable housing assembly 1324, remote control assembly 1326, and / or charger 1320.

[0235] 89A-89B , wall charger 1350 may include a recess 1352 configured to receive remote control assembly 1354. Wall charger 1350 may also include a recess 1356 configured to receive reusable housing assembly 1358. Wall charger 1350 may be configured to position remote control assembly 1354 and reusable housing assembly 1358 in a generally side-by-side configuration, thereby providing a relatively thin profile. Charger 1350 may additionally include electrical plug 1360, which may be configured to be plugged into an electrical receptacle, for example. Electrical plug 1360 may include a storable configuration in which electrical plug 1360 may be pivotable between a deployed position (e.g., as shown) and a stowed position. In the deployed position, electrical plug 1360 may be oriented to be plugged into an electrical receptacle. In the stowed position, the electrical plug 1360 may be disposed within a recess 1362, which may protect the electrical plug 1308 from damage and / or from damaging other items.

[0236] Infusion pump therapy may include volume and time specifications. The amount of fluid dispensed along with dispense timing may be two important factors in infusion pump therapy. As discussed in detail below, the infusion pump instruments and systems described herein may provide methods for dispensing fluids, along with devices, systems, and methods for measuring the amount of fluid dispensed. However, in situations where calibration and accuracy of the measurement device are important, it may be advantageous to determine any degradation in the accuracy of the measurement device as soon as possible. Therefore, off-board verification of volume and delivery is advantageous.

[0237] As discussed above, infusion pump assembly 100 may include a volume sensor assembly 148 configured to monitor the amount of fluid infused by infusion pump assembly 100. Additionally, as discussed above, infusion pump assembly 100 may be controlled such that volume measurements produced by volume sensor assembly 148 may be used to control, via a feedback loop, the amount of infusible fluid infused into the user.

[0238] 90A-90C, one line drawing and two cross-sectional views of the volume sensor assembly 148 are shown. Also referring to FIGS. 91A-91I, various isometric and line drawings of the volume sensor assembly 148 (shown to include the upper housing 1400) are shown. Also referring to FIGS. 92A-92I, various isometric and line drawings of the volume sensor assembly 148 (with the upper housing 1400 removed) are shown, exposing the speaker assembly 622, the reference microphone 626, and the printed circuit board assembly 830. Also referring to FIGS. 93A-93I, various isometric and line drawings of the volume sensor assembly 148 (with the printed circuit board assembly 830 removed) are shown, exposing the port assembly 624. Also referring to FIGS. 94A-94F, various isometric and line cross-sectional views of the volume sensor assembly 148 (with the printed circuit board assembly 830 removed) are shown, exposing the port assembly 624. Referring also to FIG. 95, the upper housing 1400, the spindle An exploded view of the volume sensor assembly 148 is shown, exposing the locator assembly 622, the reference microphone 626, the seal assembly 1404, the lower housing 1402, the port assembly 624, the spring diaphragm 628, and the retaining ring assembly 1406.

[0239] The following discussion relates to the design and operation of volume sensor assembly 148 (shown in simplified form in FIG. 96). For the discussion that follows, the following nomenclature may be used:

[0240] [Table 5] (Derivation of the equation for the volume sensor assembly 148:) (Acoustic volume modeling) The pressure and volume of an ideal adiabatic gas may be related by:

[0241]

number

[0242] Equation 1 may be expressed in terms of mean pressure P and volume V, plus small time-dependent perturbations p(t), v(t), as follows:

[0243]

number

[0244]

number

[0245]

number

[0246]

number

[0247]

number

[0248]

number

[0249]

number

[0250] By applying the ideal gas law P=ρRT and substituting for pressure, the following equation may be obtained:

[0251]

number

[0252]

number

[0253]

number

[0254]

number

[0255]

number

[0256]

number

[0257]

number

[0258]

number

[0259]

number

[0260]

number

[0261]

number

[0262]

number

[0263]

number

[0264]

number

[0265]

number

[0266] Referring also to FIG. 97, a Bode plot of Equation 23 is shown.

[0267] The difficulty with this relationship is that the complex poles depend on the variable volume V2 and the reference volume V1. Changes in the mean position of the loudspeakers can introduce errors in the estimated volume.

[0268] (mutual port transfer function) The relationship between the two volumes on either side of the acoustic port may be called the cross-port transfer function. This relationship is:

[0269]

number

[0270] This relationship has the advantage that the poles depend only on the variable volume and not on the reference volume. However, it has the difficulty that the resonance peak is actually due to an inversion of the zero as a function of the reference volume pressure. Therefore, pressure measurements in the reference chamber will have low amplitudes near the resonance, potentially increasing measurement noise.

[0271] (mutual speaker transfer function) Pressure may also be measured from both sides of the speaker, this is called the reciprocal speaker transfer function. Be found out.

[0272]

number

[0273] This transfer function has a set of complex zeros in addition to a set of complex poles.

[0274] Looking at the limit of this transfer function,

[0275]

number

[0276]

number

[0277] (Resonant Q and Peak Response) The quality of resonance is the ratio of stored energy to power loss multiplied by the resonant frequency. For a pure second-order system, the Q factor may be expressed as a function of the damping ratio:

[0278]

number

[0279]

number

[0280]

number

[0281]

number

[0282]

number

[0283] The resonant frequency may be determined in a physical system using a number of methods. A phase-locked loop may be employed to determine the 90° phase point, which may correspond to the system's natural frequency. Alternatively, the resonant frequency may be calculated using the phase at any two frequencies.

[0284] The phase φ at a given frequency satisfies the following relationship:

[0285]

number

[0286]

number

[0287] The value of V2 is calculated as follows:

[0288]

number

[0289]

number

[0290] Rewriting equation 33 for variable volume gives:

[0291]

number

[0292] The transfer function of a system may be expressed as a rational function of s. The general case is expressed as follows for a transfer function with an nth-order numerator and an mth-order denominator: N and D are the numerator and denominator coefficients, respectively. The expression has been normalized so that the leading coefficient of the denominator is 1.

[0293]

number

[0294]

number

[0295]

number

[0296]

number

[0297]

number

[0298]

number

[0299]

number

[0300]

number

[0301]

number

[0302]

number

[0303]

number

[0304]

number

[0305] To simplify the algorithm, some of the terms may be combined:

[0306]

number

[0307]

number

[0308] To find an expression for D in terms of the complex response vector G and the natural frequency s=jω, X may be separated into its real and imaginary parts.

[0309]

number

[0310]

number

[0311]

number

[0312]

number

[0313]

number

[0314]

number

[0315]

number

[0316]

number

[0317] The determinant may then be calculated for the values ​​of the adjoint matrix using the zero elements in the original array.

[0318]

number

[0319]

number

[0320]

number

[0321]

number

[0322]

number

[0323]

number

[0324]

number

[0325] (Alternative solution of second-order systems)

[0326]

number

[0327]

number

[0328]

number

[0329]

number

[0330] The coefficients of this transfer function may be found based on the formula found in the previous section as follows:

[0331]

number

[0332]

number

[0333] To simplify the algorithm, some terms may be combined as follows:

[0334]

number

[0335]

number

[0336] To find an expression for D in terms of the complex response vector G and the natural frequency s=jω, X may be separated into its real and imaginary parts.

[0337]

number

[0338]

number

[0339]

number

[0340]

number

[0341]

number

[0342] Additionally, the overall signal variance may be calculated and compared to the variance of a pure tone extracted using a discrete Fourier transform (i.e., DFT). This may provide a measure of how much of the signal power comes from noise sources or distortion. This value may then be used to invalidate and repeat bad measurements.

[0343] (Discrete Fourier Transform Calculation) The signal from the microphone may be sampled synchronously with the output to the speaker assembly 622 to take a fixed number of points N per wavelength. The measured signal at each wavelength point may be summed over an integer number of wavelengths M and stored by the ISR in an array x for processing after all data for that frequency has been collected.

[0344] The DFT may be performed on the data at integer values ​​corresponding to the driving frequency of the speaker. The general formula for the first harmonic of the DFT is:

[0345]

number

[0346]

number

[0347]

number

[0348]

number

[0349]

number

[0350]

number

[0351]

number

[0352] (Calculation of signal variance) The pseudovariance of a signal may be calculated using the following relationship:

[0353]

number

[0354] The sum is approximately

[0355]

number

[0356]

number

[0357] (Calculation of relative microphone response) The relative response (G) of the microphones 626, 630 may be calculated from the complex responses of the individual microphones.

[0358]

number

[0359]

number

[0360]

number

[0361]

number

[0362] The simultaneous equations describing the three-chamber configuration may be as follows:

[0363]

number

[0364]

number

[0365]

number

[0366]

number

[0367]

Number

[0368]

Number

[0369]

Number

[0370] The time delay may be expressed in the Laplace domain as follows.

[0371]

Number

[0372]

number

[0373] (3 chamber volume estimate) The volume sensor assembly 148 may also be configured with a third reference volume (e.g., reference volume 1508, FIG. 103) connected to a separate resonant port (e.g., port 1510, FIG. 103). This configuration may allow for temperature-independent volume estimation.

[0374] The equation representing the three-chamber configuration may be as follows:

[0375]

number

[0376]

number

[0377]

number

[0378]

number

[0379]

number

[0380] The volume of the volume sensor chamber 620 may be estimated using the ratio of the natural frequencies of the two resonant ports as follows:

[0381]

number

[0382] (Exponential volume model) Assume that the outflow through the flow resistance is of the form:

[0383]

number

[0384]

number

[0385]

number

[0386]

number

[0387]

number

[0388]

number

[0389]

number

[0390]

number

[0391]

number

[0392] (implementation details) (end effect) Air resonating in a port (e.g., port assembly 624) may extend into the acoustic volume at the end of each oscillation. The distance the air extends may be estimated based on the basic volume sensor assembly equation. For a given acoustic volume, the distance the air extends into the volume may be expressed as a function of pressure and the port cross-sectional area.

[0393]

number

[0394]

number

[0395] Therefore, the air extends approximately 1.9 mm into the acoustic chamber.

[0396] (Dimensioning of V1 (i.e., fixed volume) relative to V2 (i.e., variable volume)) The sizing of V1 (e.g., fixed volume 1500) may require an acoustic volume tradeoff with the relative locations of poles and zeros in the transfer function. The transfer functions of both V1 and V2 (e.g., variable volume 1502) are shown below versus the volume displacement of the speaker assembly 622:

[0397]

number

[0398]

number

[0399] As V1 is increased, the gain may decrease, and the speaker may be driven at a higher amplitude to obtain the same sound pressure level. However, increasing V1 may have the benefit of moving the complex zeros in the p1 transfer function toward the complex poles. In the limiting case where V1 → ∞, α → 1, there is pole-zero cancellation and a flat response. Thus, increasing V1 reduces both the resonance and the notch in the p1 transfer function, and ω n It may be advantageous to move the p2 pole towards , resulting in less sensitivity to measurement errors when calculating the p2 / p1 transfer function.

[0400] Figure 104 is a graphical representation of the following equation:

[0401]

number

[0402]

number

[0403]

number

[0404] The demodulation routine may effectively remove noise except at certain frequencies of the demodulation. If the sample frequency is dynamically set to be a fixed multiple of the demodulation frequency, the frequencies of the noise that can alias down to the demodulation frequency may be a fixed set of harmonics of that fundamental frequency.

[0405] For example, if the sampling frequency is eight times the demodulation frequency, the noise frequency that can be aliased down to that frequency is:

[0406]

number

[0407]

number

[0408]

number

[0409]

number

[0410]

number

[0411] However, the measurement may be more susceptible to noise in the temperature measurement: temperature changes during a differential sine sweep may result in errors that appear as offsets rather than gain changes.

[0412]

number

[0413] The LM73 temperature sensor may have a published accuracy of + / - 1°C and a resolution of 0.03°C. Additionally, the LM73 temperature sensor appears to consistently have a start-up transient of about 0.3°C that takes about five sine sweeps to settle (as shown in Figure 108).

[0414] Because the above-described infusion pump assemblies (e.g., infusion pump assemblies 100, 100', 400, 500) provide discrete delivery of infusible fluid, the above-described infusion pump assemblies may be modeled entirely in the discrete domain (in the manner shown in FIG. 109), which may be summarized in the following equation:

[0415]

number

[0416]

number

[0417] For the following discussion, the following nomenclature may be used:

[0418] [Table 6] As part of the demodulation routine employed in each frequency response calculation, minimum and maximum measurements may be calculated for both the fixed volume microphone 626 and the variable volume microphone 630. The sum of these maximum and minimum values ​​may be calculated over the entire sinusoidal sweep (as discussed above) for both microphone 626 and microphone 630 as follows:

[0419]

number

[0420]

number

[0421]

number

[0422]

number

[0423] The thresholding for the above algorithms may be based entirely on numerical evidence. For example: A normal min / max response difference examination may show that no individual difference is less than 500 ADC counts. Thus, all data examined while disposable housing assembly 114 is detached from reusable housing assembly 102 may show all min / max response differences as being well below 500 ADC counts. Thus, the threshold for δ may be set at T=500.

[0424] Although volume sensor assembly 148 is described above as being utilized within an infusion pump assembly (e.g., infusion pump assembly 100), this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other configurations are possible and are considered within the scope of the present disclosure. For example, volume sensor assembly 148 may be used within a process control environment, e.g., to control the amounts of chemicals mixed together. Alternatively, volume sensor assembly 148 may be used within a beverage dispensing system, e.g., to control the amounts of ingredients mixed together.

[0425] While the volume sensor assembly 148 has been 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 considered within the scope of the present disclosure. For example, a solid mass (not shown) may be suspended within the port assembly 624 and serve as the resonator for the volume sensor assembly 148. Specifically, the resonator mass (not shown) may be suspended on a diaphragm (not shown) that spans the port assembly 624. Alternatively, the diaphragm itself (not shown) may serve as the resonator mass. The natural frequency of the volume sensor assembly 148 may be a function of the volume of the variable volume 1502. Thus, if the natural frequency of the volume sensor assembly 148 can be measured, the volume of the variable volume 1502 may be calculated.

[0426] The natural frequency of the volume 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 volume sensor assembly 148. Alternatively, a mass (not shown) may be perturbed and then caused to vibrate. The unforced motion of the mass (not shown) may then be used to calculate the natural frequency of the volume sensor assembly 148.

[0427] The force applied to the resonating mass (not shown) may be achieved in a variety of ways, examples of which may include, but are not limited to: · The speaker assembly 622 may generate a time-varying pressure within the fixed volume 1500. · The resonant mass (not shown) may be a piezoelectric material that responds to a time-varying voltage / current. A resonant mass (not shown) may be a voice coil that responds to a time-varying voltage / current.

[0428] The force applied to the resonating mass may be measured in a variety of ways, examples of which may include, but are not limited to: ·Measure pressure in a fixed volume. The resonant mass (not shown) may be a piezoelectric material. A strain gauge may be connected to a diaphragm (not shown) or other structural member supporting a resonating mass (not shown).

[0429] Similarly, the displacement of the resonating mass (not shown) may be measured by measuring the pressure in a variable volume or may be measured directly in a variety of ways, examples of which may include, but are not limited to, the following: Via a piezoelectric sensor. Via a volume sensor. Via optical sensors. Via Hall effect sensors. · Via potentiometer (time varying impedance) sensors. Via inductive sensors. Via a Linear Variable Differential Transformer (LVDT).

[0430] Additionally, the resonating mass (not shown) may be integral with either the force-type sensor or the displacement-type sensor (ie, the resonating mass (not shown) may be made of a piezoelectric material).

[0431] The application of force and measurement of displacement may be accomplished by a single device. For example, a piezoelectric material may be used with a 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 volume sensor assembly 148.

[0432] As discussed above, the resonant frequency of the volume sensor assembly 148 may be estimated using swept sine wave system identification. Specifically, the above model fitting may allow the resonant frequency of the port assembly to be extracted from the sine wave sweep data, which may then be used to determine the delivery volume. The ideal relationship between resonant frequency and delivery volume may be expressed as follows:

[0433]

number

[0434]

number

[0435]

number

[0436]

number

[0437] Infusion pump assembly 100 may then compare this calculated volume V2 (i.e., representing the actual volume of infusible fluid delivered to the user) with the target volume (i.e., representing the amount of fluid that was to be delivered to the user). For example, assume that infusion pump assembly 100 was to deliver a 0.100 unit basal dose of infusible fluid to the user every 30 minutes. Further assume that upon achieving such delivery, volume sensor assembly 148 indicates a calculated volume V2 of 0.095 units of infusible fluid (i.e., representing the actual volume of infusible fluid delivered to the user).

[0438] When calculating volume V2, infusion pump assembly 100 may first determine the volume of fluid in volume sensor chamber 620 before administration of the dose of infusible fluid, and later determine the volume of fluid in volume sensor chamber 620 after administration of the dose of infusible fluid, with the difference between these two measurements indicating volume V2 (i.e., the actual volume of infusible fluid delivered to the user). Thus, V2 is a differential measurement.

[0439] V2 may be the total air space above the diaphragm in the variable volume chamber. The actual fluid delivery to the patient may be the difference in V2 from when the chamber was full to after the measurement valve was opened and the chamber was emptied. V2 may not be directly the delivered volume. For example, the air volume may be measured, or a series of differential measurements may be taken. For an occlusion, an empty measurement may be taken, the chamber may be filled, a full measurement may be taken, and then a final measurement after the outlet valve is opened may be obtained. Thus, the difference between the first and second measurements may be the volume delivered, and the difference between the second and third measurements is the volume delivered to the patient.

[0440] Thus, electrical control assembly 110 may determine that the delivered infusible fluid is 0.005 units less than desired. In response to this determination, electrical control assembly 110 may provide an appropriate signal to mechanical control assembly 104 so that any additional required doses may be delivered. Alternatively, electrical control assembly 110 may provide an appropriate signal to mechanical control assembly 104 so that the additional dose may be dispensed with the next dose. Thus, during administration of the next 0.100 unit dose of infusible fluid, the output command to the pump may be modified based on the difference between the target and delivered amount.

[0441] Referring also to FIG. 110, one particular implementation of a control system for controlling the amount of infusible fluid currently being infused based at least in part on a previously administered amount of infusible fluid is shown. Specifically, and continuing with the above example, assume for illustrative purposes that electrical control assembly 110 requests delivery of a 0.100 unit dose of infusible fluid to a user. Accordingly, electrical control assembly 110 may provide to volume controller 1602 a target differential volume signal 1600 (identifying a 0.010 unit fractional basal dose of infusible fluid per cycle of shape-memory actuator 112). Thus, in this particular example, shape-memory actuator 112 would need to be cycled 10 times to achieve the desired basal dose of 0.100 units of infusible fluid. (i.e., 10 cycles x 0.010 units = 0.100 units). Volume controller 1602 may then provide an "on time" signal 1606 to an SMA (i.e., shape memory actuator) controller 1608. A battery voltage signal 1610 is also provided to SMA controller 1608.

[0442] Specifically, shape memory actuator 112 may be controlled by varying the amount of thermal energy (e.g., joules) applied to shape memory actuator 112. Thus, if the voltage level of battery 606 is reduced, the amount of joules applied to shape memory actuator 112 may also be reduced for a defined period of time. Conversely, if the voltage level of battery 606 is increased, the amount of joules applied to shape memory actuator 112 may also be increased for a defined period of time. Thus, by monitoring the voltage level of battery 606 (via battery voltage signal 1610), the type of signal applied to shape memory actuator 112 may be varied to ensure that an appropriate amount of thermal energy is applied to shape memory actuator 112 regardless of the battery voltage level.

[0443] SMA controller 1608 may process “on-time” signal 1606 and battery voltage signal 1610 to determine an appropriate SMA drive signal 1612 to apply to shape-memory actuator 112. One example of an SMA drive signal 1612 may be a series of binary pulses, where the amplitude of SMA drive signal 1612 essentially controls the stroke length of shape-memory actuator 112 (and thus pump assembly 106), and the duty cycle of SMA drive signal 1612 essentially controls the stroke rate of shape-memory actuator 112 (and thus pump assembly 106). Furthermore, because SMA drive signal 1612 indicates differential volume (i.e., the volume infused during each cycle of shape-memory actuator 112), SMA drive signal 1612 may be integrated by discrete-time integrator 1614 to generate volume signal 1616, which may indicate the total amount of infusible fluid infused during multiple cycles of shape-memory actuator 112. For example, since it may take 10 cycles of the shape memory actuator 112 (at 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 volume of injectable fluid (as represented by the volume signal 1616) injected.

[0444] SMA drive signal 1612 may actuate pump assembly 106, for example, for one cycle, resulting in the filling of volume sensor chamber 620 included within volume sensor assembly 148. Infusion pump assembly 100 may then make a first measurement of the quantity of fluid contained within volume sensor chamber 620 (as discussed above). Further, as discussed above, measurement valve assembly 610 may later be energized, causing all or a portion of the fluid in volume sensor chamber 620 to be delivered to the user. Infusion pump assembly 100 may then make a measurement of the quantity of fluid contained within volume sensor chamber 620 (as explained above) and use these two measurements to determine V2 (i.e., the actual volume of infusible fluid delivered to the user during the current cycle of shape memory actuator 112). Once determined, V2 (i.e., as represented by signal 1618) may be provided (i.e., fed back) to volume controller 1602 for comparison with a previously received target differential volume.

[0445] Continuing with the example above, where the differential target volume was 0.010 units of infusible fluid, assume that V2 (i.e., as represented by signal 1618) identifies 0.009 units of infusible fluid as having been delivered to the user. Accordingly, infusion pump assembly 100 would increase the next differential target volume to 0.011 units, decreasing the previous 0.001 The unit storage may be offset. Thus, as discussed above, the amplitude and / or duty cycle of SMA drive signal 1612 may be increased when delivering the next basal dose of infusible fluid to the user. This process may be repeated for the remaining nine cycles of shape-memory actuator 112 (as discussed above), and discrete-time integrator 1614 may integrate SMA drive signal 1612 (to generate volume signal 1616), which may define the total volume of infusible fluid delivered to the user.

[0446] Referring also to FIG. 111 , one possible embodiment of the volume controller 1602 is shown. In this particular implementation, the volume controller 1602 may include a PI (proportional integrator) controller 1650. The volume controller 1602 may include a feedforward controller 1652 for setting an initial “guesstimate” for the “on-time” signal 1606. For example, for the situation described above in which the target differential volume signal 1600 identifies a partial basal dose of 0.010 units of infusible fluid per cycle of the shape-memory actuator 112, the feedforward controller 1652 may define an initial “on-time” of, for example, 1 millisecond. The feedforward controller 1652 may include, for example, a lookup table that defines the initial “on-time” based at least in part on the target differential volume signal 1600. The volume controller 1602 may further include a discrete time integrator 1654 for integrating the target differential volume signal 1600 and a discrete time integrator 1656 for integrating V2 (ie, as represented by signal 1618).

[0447] Referring also to FIG. 112, one possible embodiment of the feedforward controller 1652 is shown. In this particular implementation, the feedforward controller 1652 may define a constant value signal 1658 and may include an amplifier 1660 (e.g., a unity gain amplifier), the output of which may be summed with the constant value signal 1658 at a summing node 1662. The resulting sum signal (i.e., signal 1664) may be provided as an input signal to, for example, a lookup table 1666, which may be processed to generate an output signal of the feedforward controller 1652.

[0448] As discussed above, the pump assembly 106 may be controlled by the shape memory actuator 112. Additionally, as discussed above, the SMA controller 1608 may process the “on time” signal 1606 and the battery voltage signal 1610 to determine an appropriate SMA drive signal 1612 to apply to the shape memory actuator 112.

[0449] 113-114, one specific implementation of SMA controller 1608 is shown. As discussed above, SMA controller 1608 may be responsive to "on-time" signal 1606 and battery voltage signal 1610 and may provide SMA drive signal 1612 to shape memory actuator 112. SMA controller 1608 may include a feedback loop (including unit delay 1700), the output of which may be multiplied by battery voltage signal 1610 in multiplier 1702. The output of multiplier 1702 may be amplified, for example, by unity gain amplifier 1704. The output of amplifier 1704 may be applied to the negative input of summing node 1706 (to which "on-time" signal 1606 is applied). The output of summing node 1706 may be amplified (e.g., via unity gain amplifier 1708). The SMA controller may also include a feedforward controller 1710 (similar to the feedforward controller 1652 of the volume controller 1602, see FIG. 112) to provide an initial value for the SMA drive signal 1612. The output of the feedforward controller 1710 may be summed with the output of the amplifier 1708 and an integral representation of the output of the amplifier 1708 (i.e., signal 1714) at a summing node 1712 to form the SMA drive signal 1612.

[0450] SMA drive signal 1612 may be provided to a control circuit that effects the application of force to shape memory actuator 112. For example, SMA drive signal 1612 may be applied to a switching assembly 1716, which may selectively apply a current signal 1718 (supplied from battery 606) and / or a fixed signal 1720 to the shape memory actuator. For example, SMA drive signal 1612 may effect the application of energy (supplied from battery 606 via current signal 1718) via switching assembly 1716 in a manner that achieves a duty cycle defined by SMA drive signal 1612. Unit delay 1722 may generate a delayed version of the signal applied to shape memory actuator 112 to form battery voltage signal 1610 (which may be applied to SMA controller 1608).

[0451] When applying power to the shape memory actuator 112, the voltage may be applied for a fixed amount of time at a) a fixed duty cycle with unadjusted voltage, b) a fixed duty cycle with adjusted voltage, c) a variable duty cycle based on a measured current value, d) a variable duty cycle based on a measured voltage value, and e) a variable duty cycle based on the square of the measured voltage value. Alternatively, the voltage may be applied to the shape memory actuator 112 for a variable amount of time based on the measured impedance.

[0452] When applying an unadjusted voltage for a fixed amount of time at a fixed duty cycle, inner loop feedback may be used and the shape memory actuator may be driven at a fixed duty cycle and with an on-time determined by the outer volume loop.

[0453] When applying a regulated voltage for a fixed amount of time at a fixed duty cycle, inner loop feedback may not be used and the shape memory actuator may be driven at a fixed duty cycle and with an on-time determined by the outer volume loop.

[0454] Based on the measured current value, the actual current applied to the shape memory actuator 112 when applying an unadjusted voltage to a variable constant duty cycle may be measured, and the duty cycle may be adjusted during operation of the shape memory actuator 112 to maintain the correct average current.

[0455] When applying an unadjusted voltage to a variable constant duty cycle based on the measured voltage value, the actual voltage applied to the shape memory actuator 112 may be measured and the duty cycle may be adjusted during operation of the shape memory actuator 112 to maintain the correct average voltage.

[0456] When applying an unadjusted voltage to a variable constant duty 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 duty cycle may be adjusted during operation of the shape memory actuator 112 to maintain the square of the voltage at a level necessary to provide the desired level of power to the shape memory actuator 112 (based on the impedance of the shape memory actuator 112).

[0457] Referring also to Figures 114A-114B, other implementations of the SMA controller 1608 are shown. Specifically, Figure 114A is an electrical circuit diagram that may include a microprocessor and various control loops that may be configured to provide PWM signals that may open or close a switch assembly. The switch assembly may control the current that is allowed to flow through the shape memory actuator. A battery may provide current to the shape memory actuator. Additionally, Figure 114B shows a volume 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 be achieved by using a fixed This may occur on-time, resulting in a volume that may be measured by the volume sensor assembly 148 and fed back to the volume controller.

[0458] In a preferred embodiment, the duty cycle is varied based on the measured battery voltage to provide a fairly consistent power. The duty cycle is adjusted to compensate for lower battery voltage. Battery voltage may change 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 drops due to internal impedance. This occurs in any system, and the duty cycle is adjusted to compensate for this, thus mitigating lower or fluctuating battery voltage. Battery voltage may be measured by a microprocessor. In other systems, 1) the voltage may be regulated (putting a regulator in to maintain the voltage at a stable voltage), or 2) feedback may be based on something else (i.e., motor speed or position, which does not necessarily measure battery voltage).

[0459] Other configurations may be utilized to control the shape memory actuator. For example, A) the shape memory actuator may be controlled at a fixed duty cycle with an unadjusted voltage. As the voltage varies, the repeatability of heating of the shape memory actuator is reduced. B) A fixed duty cycle with an adjusted voltage may be utilized that compensates for changes in battery voltage. However, adjusting the voltage downward is less energy efficient. C) The duty cycle may be varied based on changes in current (which may require more complex measurement circuitry). D) The duty cycle may be varied based on a measured voltage. E) The duty 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 for a variable amount of time based on a measured impedance (e.g., a Wheatstone gauge (not shown) may be used to measure the impedance). The impedance of the shape memory actuator may be correlated to strain (i.e., how much the SMA moves may be correlated based on its impedance).

[0460] 115 , as discussed above, to improve the safety of infusion pump assembly 100, electrical control assembly 110 may include two separate and distinct microprocessors: supervisor processor 1800 and command processor 1802. Specifically, command processor 1802 may perform the functions discussed above (e.g., generating SMA drive signal 1612) and may control relay / switch assemblies 1804, 1806, which (in this example) control the functionality of shape-memory actuators 112, 632 (respectively). Command processor 1802 may receive feedback from signal conditioner 1808 regarding the state (e.g., voltage level) of the voltage signal applied to shape-memory actuators 112, 632. Command processor 1800 may control relay / switch assembly 1810 independently of relay / switch assemblies 1804, 1806. Thus, when an infusion event is desired, both supervisor processor 1800 and command processor 1802 must agree that an infusion event is appropriate and both must activate their respective relays / switches. If either supervisor processor 1800 or command processor 1802 fails to activate their respective relays / switches, the infusion event will not occur. Thus, through supervisor processor 1800 and command processor 1802 and the coordination and simultaneity that must occur, the safety of infusion pump assembly 100 is enhanced.

[0461] The supervisor processor may prevent the command processor from delivering when it should not, and may prevent the command processor from delivering when it should be delivering. The supervisor processor may also deactivate the relay / switch assembly if the command processor activates the wrong switch or if the command processor attempts to apply power for too long.

[0462] The supervisor processor may perform redundant calculations (i.e., double-check the command processor's calculations) as to how much insulin should be delivered. The command processor may determine the delivery schedule, and the supervisor processor may redundantly check these calculations.

[0463] The supervisor may also keep a profile (delivery profile) redundantly in RAM, so that the command processor may be doing the right calculations, but if there is bad RAM, the command will give wrong results. The supervisor may use a local copy of the base profile, for example, to double-check.

[0464] Supervisors can double-check AVS measurements, look at AVS calculations and apply safety checks. A double-check is performed every time an AVS measurement is taken.

[0465] 116, one or more of supervisor processor 1800 and command processor 1802 may perform diagnostics on various portions of infusion pump assembly 100. For example, voltage dividers 1812, 1814 may be configured to monitor voltages (V1 and V2, respectively), for example, sensed at the distal end of shape-memory actuator 112. Knowing the signals applied to relay / switch assemblies 1804, 1810, the values ​​of voltages V1 and V2 (as shown in exemplary diagnostic table 1816) allow diagnostics to be performed on various components of the circuitry shown in FIG. 116.

[0466] As discussed above and illustrated in FIGS. 115-116 , to improve the safety of infusion pump assembly 100, 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 delivery of a dose of infusible fluid. If the microprocessors fail to interact / operate simultaneously, delivery of the dose of infusible fluid may fail and one or more alarms may be triggered, thus improving the safety and reliability of infusion pump assembly 100.

[0467] A master alarm may be utilized that tracks the volume error over time. Thus, if the total error becomes too large, the master alarm may be activated, indicating that there may be an abnormality in the system. Thus, the master alarm may indicate the total volume comparison being made and the discrepancy being noted. A typical value for the discrepancy required to activate the master alarm may be 1.00 milliliters. The master alarm may monitor the total in a leaky fashion (i.e., the inaccuracy has a time horizon).

[0468] 117A-117B, one such illustrative example of such interaction between multiple microprocessors during delivery of a dose of infusible fluid is shown. Specifically, command processor 1802 may first determine 1900 the available volume of infusible fluid in volume sensor chamber 620. Command processor 1802 may then provide 1902 a "pump power request" message to supervisor processor 1800. Upon receiving 1904 the "pump power request" message, supervisor processor 1800 may, for example, energize 1906 relay / switch 1810 (thus energizing shape-memory actuator 112) and send 1908 a "pump power on" message to command processor 1802. The "pump power on" message Upon receiving 1910 the command processor 1802 may, for example, activate 1912 the pump assembly 106 (by energizing the relay / switch 1804), while the supervisor processor 1800 may, for example, monitor 1914 the operation of the pump assembly 106.

[0469] Once operation of pump assembly 106 is complete, command processor 1807 may provide 1914 a “pump power off” message to supervisor processor 1800. Upon receiving 1916 the “pump power off” message, supervisor processor 1800 may de-energize 1918 relay / switch 1810 and provide 1920 a “pump power off” message to command processor 1802. Upon receiving 1922 the “pump power off” message, command processor 1802 may measure 1924 the volume of infusible fluid pumped by pump assembly 106. This may be accomplished by measuring the current volume in volume sensor chamber 620 and comparing it to the volume determined above (in step 1900). Once determined 1924, command processor 1802 may provide 1926 a “valve open power request” message to supervisor processor 1800. Upon receiving 1928 the “valve open power requested” message, supervisor processor 1800 may energize 1930 relay / switch 1810 (thus energizing shape memory actuator 632) and may send 1932 a “valve open power on” message to command processor 1802. Upon receiving 1934 the “valve open power on” message, command processor 1802 may, for example, actuate 1936 measurement valve assembly 610 (by energizing relay / switch 1806), while supervisor processor 1800 may, for example, monitor 1938 the actuation of measurement valve assembly 610.

[0470] Once operation of measurement valve assembly 610 is complete, command processor 1802 may provide 1940 a "valve power off" message to supervisor processor 1800. Upon receiving 1942 the "valve power off" message, supervisor processor 1800 may de-energize 1944 relay / switch 1810 and provide 1946 a "valve power off" message to command processor 1802.

[0471] Upon receiving 1948 the "valve power off" message, command processor 1802 may provide 1950 a "valve close power request" message to supervisor processor 1800. Upon receiving 1952 the "valve close power request" message, supervisor processor 1800 may energize 1954 relay / switch 1810 (thus energizing shape-memory actuator 652) and may send 1956 a "power on" message to command processor 1802. Upon receiving 1958 the "power on" message, command processor 1802 may operate 1960 an energizing relay / switch (not shown) configured to energize shape-memory actuator 652, while supervisor processor 1800 may, for example, monitor 1962 the operation of shape-memory actuator 652.

[0472] As discussed above (and with brief reference to FIGS. 26A, 26B, 27A, 27B, and 28), a shape memory actuator 652 may be secured to a first end using electrical contacts 654. The other end of the shape memory actuator 652 may be connected to a bracket assembly 656. When the shape memory actuator 652 is activated, the shape memory actuator 652 may pull the bracket assembly 656 forward, releasing the valve assembly 634. As such, the measurement valve assembly 610 may be activated via the shape memory actuator 632. Once the measurement valve assembly 610 is activated, the bracket assembly 656 may manually latch onto the valve assembly 610 in the activated position. By actuating the shape memory actuator 652, the bracket assembly 656 may Bracket assembly 656 may be pulled forward to release valve assembly 634. Once bracket assembly 656 releases valve assembly 634, assuming shape memory actuator 632 is no longer activated, measurement valve assembly 610 may be deactivated. Thus, actuating shape memory actuator 652 may cause measurement valve assembly 610 to be deactivated.

[0473] Once actuation of shape memory actuator 652 is complete, command processor 1802 may provide 1964 a "power off" message to supervisor processor 1800. Upon receiving 1966 the "power off" message, supervisor processor 1800 may de-energize 1968 relay / switch 1810 and provide 1970 a "power off" message to command processor 1802. Upon receiving 1972 the "power off" message, command processor 1802 may determine 1974 the volume of infusible fluid in volume sensor chamber 620, thus allowing command processor 1802 to compare this measured volume with the volume determined above (in step 1924) to determine the volume of infusible fluid delivered to the user.

[0474] If the amount of infusible fluid delivered to the user 1974 is less than the amount of infusible fluid specified for the basal / bolus infusion event, the above procedure may be repeated (via loop 1976).

[0475] 118, another illustrative example of the interaction between processors 1800, 1802 during scheduling of a dose of infusible fluid is shown. Command processor 1802 may monitor 2000, 2002 for receipt of a basal scheduling message or a bolus request message (respectively). Upon receipt of either of these messages 2000, 2002, command processor 1802 may set a desired delivery volume 2004 and may provide 2006 a "delivery request" message to supervisor processor 1800. Upon receiving 2008 the "delivery request" message, supervisor processor 1800 may verify 2010 the volume 2004 defined by command processor 1802. Once verified 2010, supervisor processor 1800 may provide 2012 a "delivery accepted" message to command processor 1802. Upon receiving 2014 a "delivery accepted" message, command processor 1802 may update 2016 a controller (e.g., the controller discussed above and shown in FIG. 110) to execute 2018 delivery of a basal / bolus dose of infusible fluid. Command processor 1808 may monitor and update 2022 the total amount of infusible fluid delivered to the user (as discussed above and shown in FIGS. 117A-117B). Once the appropriate amount of infusible fluid has been delivered to the user, command processor 1802 may provide 2024 a "delivery completed" message to supervisor processor 1800. Upon receiving 2026 a "delivery completed" message, supervisor processor 1800 may update 2028 the total amount of infusible fluid delivered to the user. If the total amount 2018 of infusible fluid delivered to the user is less than the amount specified above (in step 2004), the infusion process discussed above may be repeated (via loop 2030).

[0476] Referring also to FIG. 119, an example of how the supervisor processor 1800 and command processor 1802 may interact while achieving volumetric measurements via the volume sensor assembly 148 (as described above) is shown.

[0477] Specifically, the command processor 1802 may initialize 2050 the volume sensor assembly 148 and begin collecting 2052 data from the volume sensor assembly 148, a process that may be repeated for each frequency utilized in the sinusoidal sweep described above. Each time a data point is collected for a given sweep frequency, a data point message may be provided 2054 from command processor 1802 which may be received 2056 by supervisor processor 1800 .

[0478] Once data collection 2052 is complete for the entire sinusoidal sweep, command processor 1802 may estimate 2058 the volume of infusible fluid delivered by infusion pump assembly 100. Command processor 1802 may provide 2060 a volume estimate message to supervisor processor 1800. Upon receiving 2062 this volume estimate message, supervisor processor 1800 may check (i.e., verify) 2064 the volume estimate message. Once checked (i.e., verified), supervisor processor 1800 may provide 2066 a verification message to command processor 1802. Once received 2068 from supervisor processor 1800, command processor 1802 may set a measurement state for the dose of infusible fluid delivered by volume sensor assembly 148.

[0479] As discussed above, and with brief reference to FIG. 11 , various embodiments of the infusion pump assemblies discussed above (e.g., infusion pump assemblies 100, 100′, 400, 500) may be configured via remote control assembly 300. When configured via remote control assembly 300, the infusion pump assembly may include telemetry circuitry (not shown) that enables communication (e.g., wired or wireless) between the infusion pump assembly and, for example, remote control assembly 300, thus allowing remote control assembly 300 to remotely control the infusion pump assembly. Remote control assembly 300 (which may also include telemetry circuitry (not shown) and may be capable of communicating with the infusion pump assembly) may include a display assembly 302 and an input assembly 304. 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, multiple switch assemblies, or the like. Remote control assembly 300 may allow a user to program basal and bolus delivery events.

[0480] Remote control assembly 300 may include two processors, one of which (which may include, but is not limited to, a CC2510 microcontroller / RF transceiver available from Chipcon AS, Oslo, Norway) may be dedicated to wireless communications, for example, to communicate with infusion pump assembly 100, 100', 400, 500. A second processor included within the remote control assembly (which may include, but is not limited to, an ARM920T and ARM922T manufactured by ARM Holdings PLC, United Kingdom) may be a command processor and may perform data processing tasks, for example, associated with configuring infusion pump assembly 100, 100', 400, 500.

[0481] Additionally, as discussed above, one embodiment of electrical control assembly 816 may include three microprocessors. One processor (which may include, but is not limited to, a CC2510 microcontroller / RF transceiver available from Chipcon AS (Oslo, Norway)) may be dedicated to wireless communications, for example, to communicate with remote control assembly 300. Two additional microprocessors (e.g., supervisor processor 1800 and command processor 1802) may effectuate delivery of infusible fluids (as discussed above). Examples of supervisor processor 1800 and command processor 1802 may include, but are not limited to, an MSP430 microcontroller available from Texas Instruments Inc. (Dallas, Texas).

[0482] The OS may be a non-preemptive scheduling system in that all tasks, regardless of priority, run to completion before the next task can run. Additionally, no context switching may occur. Once a task completes execution, the highest priority task currently scheduled for execution may run. If no tasks are scheduled for execution, the OS may place the processors (e.g., supervisor processor 1800 and / or command processor 1802) in a low-power sleep mode and wake them up when the next task is scheduled. The OS may be used only to manage main loop code, leaving interrupt-based functionality unaffected.

[0483] The OS may be written to utilize the C++ language. Inheritance and virtual functions may be key elements of the design, allowing for easy creation, scheduling, and management of tasks.

[0484] Underlying the OS infrastructure may be the ability to track system time and control the ability to put the processor into low power mode (LPM, also known as hibernate mode). This functionality, along with the control and configuration of all system clocks, may be encapsulated by the SysClocks class.

[0485] The SysClocks class may contain functionality to put a processor (e.g., supervisor processor 1800 and / or command processor 1802) into LPM to reduce energy consumption. While in LPM, a slow real-time clock may continue to run, while the fast system clock that runs the CPU core and most peripherals may be disabled.

[0486] Placing the processor in LPM may always be done by the provided SysClocks. This function may contain all necessary power down and power up sequences to provide consistency whenever entering or leaving LPM. Wake-up from LPM may be initiated by an interrupt based on the slow clock.

[0487] The OS may track three aspects of time: seconds, milliseconds, and time of day. Regarding seconds, SysClocks may count seconds starting when the processor comes out of reset. The seconds counter may be based on a slow system clock and therefore may increment regardless of whether the processor is in LPM or full power. As a result, this is the boundary at which the processor wakes up from hibernation to execute a previously scheduled task. If a task is scheduled to run immediately after an interrupt service routine (ISR), the ISR may wake the processor from LPM upon completion, and the task may be executed immediately. Regarding milliseconds, in addition to counting seconds since power on, SysClocks may also count milliseconds while the processor is in full power mode. The millisecond counter may not increment because the fast clock is stopped during LPM. Therefore, the processor may not be in LPM whenever a task is scheduled to run based on milliseconds. With respect to time, the time may be expressed within SysClocks as the number of seconds since a particular point in time (eg, seconds since January 1, 2004).

[0488] The SysClocks class may provide useful functionality used throughout the Command and Supervisor project code base. Code delays may be necessary to allow hardware to settle or actions to complete. SysClocks may provide two forms of delay: a delay based on seconds or a delay based on milliseconds. When a delay is used, the processor will It may simply wait until the desired time has elapsed before continuing the load path. During this time, only the ISR may execute. SysClocks may provide all of the necessary functionality to set or retrieve the current time.

[0489] The term "task" may be associated with more complex scheduling systems. Thus, within the OS, tasks may be represented by and referred to as Managed Functions. The ManagedFunc class may be an abstract base class that provides all of the controls and functionality necessary to manage and schedule the desired functionality.

[0490] The ManagedFunc base class is a pure virtual execution function that may have five control elements, two of which are scheduling operation element functions and one of which may contain managed functionality. All of the ManagedFunc control elements may be hidden from derived classes and may only be set directly by derived classes during creation, thus simplifying use and improving the safety of infusion pump assembly 100, 100', 400, 500.

[0491] Function IDs may be set at creation time and may never change. All function IDs may be specified in a single .h file, and the base ManagedFunc constructor may strongly enforce that the same ID may not be used for more than one managed function. IDs may also specify the priority of a function (relative to other functions) based on the assigned function ID, with higher priority functions being assigned lower function IDs. The highest priority task currently scheduled for execution may run before lower priority tasks.

[0492] All other control elements may be used to represent the current scheduled state of the function, when it should be executed, and if (at runtime) the function should be rescheduled in a previously set amount of time. Manipulation of these controls and states may be possible only through well-known member functions (thus implementing safety controls in all settings).

[0493] Set start and set repeat functions may be used to control the scheduling of managed functions. Each of these member functions may be a simple interface that allows for the ability to configure or disable repeat settings, as well as control whether a managed function is scheduled by seconds, milliseconds, or time of day, or is inactive.

[0494] Through inheritance, creation of managed functions may be done by creating a derived class and specifying a pure virtual "execute" function that contains the code that needs to be subject to scheduling control. The ManagedFunc base class constructor may be based on the function's unique ID, but may also be used to set default control values ​​at startup.

[0495] For example, to create a function that runs 30 seconds after starting and every 15 seconds thereafter, the desired code is put into the virtual execute function, and a start time of 30 seconds, a function ID scheduled by seconds state, and a repetition setting of 15 seconds are provided to the constructor.

[0496] Below is an example code example for 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 infusion pump assembly 100, 100', 400, 500 starts up, and then every 10 seconds thereafter. It is done.

[0497] [ka]

[0498] The actual execution of managed functions may be controlled and implemented by a sleep manager class. The sleep manager may contain the actual prioritized list of managed functions. This function prioritized list may be automatically populated by the managed function creation process, ensuring that each function is created properly and has a unique ID.

[0499] The primary role of the Sleep Manager class is to cause a "management" function to be repeatedly called from the processor's main loop and / or from a permanent while loop. On each call of management, the sleep manager executes all functions that are scheduled to be executed until the sleep manager exhausts all scheduled functions, at which point the sleep manager may place the processor in LPM. Once the processor returns from LPM, the management function may be re-entered until the processor is ready to enter LPM again (this process may be repeated, for example, until stopped by the user or by the system).

[0500] If the processor must remain in full-power mode for an extended period of time (e.g., while an analog-to-digital conversion is being sampled), the sleep manager may provide functionality to disable entering LPM. While LPM is disabled, management functions may continue to search for scheduled tasks.

[0501] The sleep manager also handles scheduling and enforces the use of unique IDs for functions. An interface may be provided through which to iterate over the configuration of any managed function, which may allow any section of code to perform any necessary scheduling without direct access to, or unnecessary knowledge of, the desired ManagedFunc object.

[0502] Wireless circuitry contained within each of infusion pump assemblies 100, 100', 400, 500 and remote control assembly 300 may effectuate wireless communication between remote control assembly 300 and infusion pump assemblies 100, 100', 400, 500. A 2.4 GHz wireless communication chip (e.g., Texas Instruments Incorporated) with an internal 8051 microcontroller may be used. A Microdevices Instruments CC2510 radio transceiver may be used for wireless communication.

[0503] A wireless link may balance three objectives: link availability, latency, and energy.

[0504] With regard to link availability, remote control assembly 300 may provide the primary means for controlling infusion pump assembly 100, 100', 400, 500 and may provide detailed feedback to the user via a graphical user interface (GUI) of remote control assembly 300. With regard to latency, the communication system may be designed to provide low latency for delivering data from remote control assembly 300 to infusion pump assembly 100, 100', 400, 500 (and vice versa). With regard to energy, both remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 may have maximum energy consumption for wireless communication.

[0505] The wireless link may support half-duplex communication. Remote control assembly 300 may be the master of the wireless link, initiating all communications. Infusion pump assemblies 100, 100', 400, 500 may only respond to communications or may never initiate communications. Use of such a wireless communication system may provide various benefits, such as enhanced security, simplified design (e.g., for aircraft applications), and coordinated control of the wireless link.

[0506] Referring also to FIG. 120A, one exemplary embodiment of the various software layers of the wireless communication system discussed above is shown.

[0507] The radio processors included within remote control assembly 300 and infusion pump assemblies 100, 100', 400, 500 may transfer messaging packets between the SPI port and the 2.4 GHz radio link (and vice versa). The radio may always be an SPI slave. On infusion pump assemblies 100, 100', 400, 500, the radio processor (PRP) 1818 (see FIGS. 115-116) may enable two additional nodes on the upstream SPI port (i.e., command processor 1800 and supervisor processor 1802). In some embodiments, on remote control assembly 300, the radio processor (CRP) may enable two additional nodes on the SPI port, which may be either upstream or downstream, for example, in some embodiments, the remote control processor (UI) and continuous glucose engine (CGE) described above.

[0508] The messaging system may enable communication of messages between various nodes in the network. The UI processor of remote control assembly 300 and, for example, supervisor processor 1800 may use the messaging system to configure and initiate some of the mode switching on the two system radios. It also allows the network It may also be used by the radio to communicate radio and link state information to other nodes in the network.

[0509] The radio of remote control assembly 300 may use a system message when it wishes to collect channel statistics from infusion pump assembly 100, 100', 400, 500 or update the master channel list of the radio of infusion pump assembly 100, 100', 400, 500. Synchronization for the new updated list to take effect may use a flag in the heartbeat message to remove timing uncertainty.

[0510] The wireless communication system may be written in C++ to be compatible with messaging software. A 4-byte radio serial number may be used to address each wireless node. A hash table may be used to provide a one-to-one translation between the device "readable" serial number string and the radio serial number. The hash table may provide a more randomized 8-bit logical address so that pumps (e.g., infusion pump assemblies 100, 100', 400, 500) or controllers with similar readable serial numbers are more likely to have unique logical addresses. Radio serial numbers may not need to be unique between (e.g., infusion pump assemblies 100, 100', 400, 500) and controllers due to the unique role each plays in the wireless protocol.

[0511] The radio serial number of remote control assembly 300 and the radio serial number of infusion pump assembly 100, 100', 400, 500 may be included in every wireless packet, except for the RF pairing request message, which may only include the radio serial number of remote control assembly 300, thus ensuring that it is only generated with the remote control assembly / infusion pump assembly that is to be paired. CC2510 may support a 1-byte logical node address, and it may be advantageous to use one byte of the radio serial number as a logical node address to provide a level of filtering of received packets.

[0512] To prevent noise interference on the board of remote control assembly 300 from other systems on board, the Quiet_Radio signal may be used by the UI processor of remote control assembly 300. When Quiet_Radio is asserted, the radio application of remote control assembly 300 sends a message to the radio of infusion pump assembly 100, 100', 400, 500 to enter radio dormancy (Radio Sleep) for a predetermined period of time. The radio of remote control assembly 300 may assert Quiet_Radio mode. The Quiet_Radio feature may not be needed based on noise and interference levels measured on the PC board of remote control assembly 300. During this period, the radio of remote control assembly 300 may remain in Sleep Mode 2 for up to 100 ms. The radio of remote control assembly 300 may exit Sleep Mode 2 when the Quiet_Radio signal is deasserted or the maximum period expires. The UI processor of remote control assembly 300 may assert Quiet_Radio for at least one radio communication interval before the event needs to be asserted. The radio of remote control assembly 300 may notify the radio of infusion pump assembly 100, 100', 400, 500 that communications will be shut down during this sleep period. The periodic radio link protocol may have a status bit / byte that accommodates the Quiet_Radio feature unless Quiet_Radio is needed.

[0513] The radio software may be integrated with the messaging system and radio bootloader on the same processor and verified using throughput testing. The radio software may be integrated with the messaging system, SPI driver with DMA, and radio bootloader, all on the same processor (e.g., TI CC2510).

[0514] The radio of remote control assembly 300 may be configured to consume only 32 mAh for three days (assuming 100 minutes of fast heartbeat mode communication per day). The radio of infusion pump assemblies 100, 100', 400, 500 may be configured to consume only 25 mAh for three days (assuming 100 minutes of fast heartbeat mode communication per day).

[0515] The maximum time to reacquire communications may be ≦6.1 seconds, including connection request mode and acquisition mode. The radio of remote control assembly 300 may advantageously use a fast heartbeat mode or slow heartbeat mode setting to conserve power and minimize latency for the user. The difference between infusion pump assembly 100, 100′, 400, 500 and remote control assembly 300 going into acquisition mode may be that infusion pump assembly 100, 100′, 400, 500 needs to go into acquisition mode frequently enough to ensure that communications may be restored within the maximum latency time. However, remote control assembly 300 may vary the frequency of going into acquisition mode with infusion pump assembly 100, 100′, 400, 500 when in slow heartbeat mode and the heartbeat is lost. The radio of remote control assembly 300 may have knowledge of user GUI interactions, while infusion pump assembly 100, 100′, 400, 500 may not.

[0516] The radio of remote control assembly 300 may set a heartbeat period for both radios. The period may be selectable to optimize power and link latency depending on activity. The desired heartbeat period may be communicated with each heartbeat from the radio of remote control assembly 300 to the radio of infusion pump assembly 100, 100', 400, 500. This may not exclusively establish the heartbeat rate of infusion pump assembly 100, 100', 400, 500, depending on other conditions that determine which mode is in effect. When in fast heartbeat mode, the radio of remote control assembly 300 may set the heartbeat period to 20 ms if it is able to send or receive data packets, thus providing low-latency communication when data is being actively exchanged.

[0517] When in fast heartbeat mode, the radio of remote control assembly 300 may set the heartbeat period to 60 ms, four heartbeats after the last time a data packet was exchanged bidirectionally over the air. Keeping the radio heartbeat period short after a packet is sent or received ensures that any data response packets may also be provided using low link latency. When in slow heartbeat mode, the heartbeat rate may be 2.00 seconds or 6.00 seconds, depending on the online or offline state, respectively.

[0518] Infusion pump assemblies 100, 100', 400, 500 may use a heartbeat rate set by the radio of remote control assembly 300. The radio of remote control assembly 300 may support the following mode requests via the messaging system: Pairing mode Connection Mode Acquisition Mode (contains the radio serial number of the desired paired infusion pump assembly 100, 100', 400, 500) Synchronous mode - fast heartbeat Synchronous mode - slow heartbeat RF Off Mode The radio of infusion pump assembly 100, 100', 400, 500 may support the following mode requests via the messaging system: Pairing mode Connection Mode RF Off Mode The radio may use a system message to obtain the local radio serial number. On remote control assembly 300, the radio may obtain the serial number from the UI processor of remote control assembly 300. The radio may use a system message to store the pairing radio serial number.

[0519] The radios of remote control assembly 300 and infusion pump assemblies 100, 100', 400, 500 may issue status messages using the messaging system to the UI processor of remote control assembly 300 and command processor 1802 whenever the following conditions change: Fast online: connection successful Fast Online: Change from Acquisition mode to Fast Heartbeat mode · Slow Online: Request to change from fast heartbeat to slow heartbeat successful Offline: Automatic change to search sync mode due to lack of heartbeat exchange · Fast Online: Successful request to change from slow heartbeat to fast heartbeat Offline: Bandwidth drops below 10% in synchronous mode Online: Bandwidth rises above 10% in search sync mode Offline: Request to change to RF off mode successful The radio configuration message may be used to configure the number of radio retries. This message may be sent over a messaging system. The UI processor of remote control assembly 300 sends this command to both the radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 to configure these radio settings.

[0520] The radio configuration message may have two parameters: the number of RF retries (e.g., the value may be from 0 to 10), and a radio offline parameter (e.g., the value may be from 1 to 100 in percentage of bandwidth).

[0521] The wireless applications of both remote control assembly 300 and infusion pump assemblies 100, 100', 400, 500 may have APIs that allow the messaging system to configure the number of RF retries and wireless offline parameters.

[0522] The following parameters may be recommended for the radio hardware configuration: Basic wireless specifications MSK Wireless communication speed of 250kbps or more Up to 84 channels 1000kHz channel spacing 812kHz filter bandwidth No Manchester encoding Data erasure 4-byte preface 4-byte synchronization (words) CRC added to packets LQI (Link Quality Indicator) added to packets Automatic CRC filtering enabled Forward error correction (FEC) may or may not be used. FEC may be used to increase the effective signal dynamic range by approximately 3 dB. FEC requires a fixed packet size and doubles the number of over-the-air bits for the same fixed-size message.

[0523] The radio may function within a distance of 1.83 meters under nominal operating conditions (excluding pairing mode). It may be a goal for the radio to function within a distance of 7.32 meters under nominal operating conditions. The transmit power level may be 0 dBm (excluding pairing mode), and the transmit power level in pairing mode may be −22 dBm. Because the desired wireless node address of infusion pump assembly 100, 100′, 400, 500 may not be known by remote control assembly 300 in pairing mode, both infusion pump assembly 100, 100′, 400, 500 and remote control assembly 300 may use a lower transmit power to reduce the possibility of inadvertently pairing with another infusion pump assembly.

[0524] AES encryption may be used for all packets, but may not be required as the Texas Instruments CC2510 radio transceiver includes this functionality. If AES encryption is used, a fixed key may be utilized since it provides a fast method for enabling encryption without passing the key. However, key exchange may be provided in future versions of the infusion pump assembly 100, 100', 400, 500. The fixed key may be contained in a separate header source with no other variables other than the fixed key data, thus allowing easier management of file read access.

[0525] The radio software may support the following eight modes: Pairing mode RF Off Mode Connection Mode Acquisition Mode Fast heartbeat mode Slow Heartbeat Mode ·Search synchronous mode Synchronization Acquisition Mode, as depicted diagrammatically in Figures 120B-120C Pairing may be the process of exchanging wireless serial numbers between remote control assembly 300 and infusion pump assembly 100, 100', 400, 500. Remote control assembly 300 may be "paired" with infusion pump assembly 100, 100', 400, 500 when the serial number is known to infusion pump assembly 100, 100', 400, 500. Infusion pump assembly 100, 100', 400, 500 may be "paired" with remote control assembly 300 when the serial number is known to remote control assembly 300.

[0526] Pairing mode (generally depicted diagrammatically in FIG. 120D) may require four messages to be exchanged over the RF link. RF pairing request (sent from remote control assembly 300 to any infusion pump assembly 100, 100', 400, 500) RF pairing approval (from infusion pump assemblies 100, 100', 400, and 500 to remote control assembly 300) RF pairing confirmation request (from remote control assembly 300 to infusion pump assembly 100, 100', 400, 500) RF Pairing Confirmation Approval (Infusion Pump Assembly 100, 100', 400, 500) to remote control assembly 300) Additionally, remote control assembly 300 may abort the pairing process at any time via an RF pairing abort message (from remote control assembly 300 to infusion pump assembly 100, 100', 400, 500). The pairing mode may not support messaging system data transfer.

[0527] The radio of infusion pump assembly 100, 100', 400, 500 may enter pairing mode upon receiving a pairing mode request message. It may be the responsibility of supervisor processor 1800 on infusion pump assembly 100, 100', 400, 500 to request the radio to enter pairing mode if there are no disposable parts attached to infusion pump assembly 100, 100', 400, 500 and the user presses a button on infusion pump assembly 100, 100', 400, 500 for six seconds. The radio of infusion pump assembly 100, 100', 400, 500 may set the appropriate transmit power level for pairing mode. Infusion pump assembly 100, 100', 400, 500 may only be paired with one remote control assembly 300 at a time.

[0528] Upon receiving the first valid RF pairing request message while in pairing mode, the radio of infusion pump assembly 100, 100', 400, 500 may respond with an RF pairing acknowledgement message using the serial number of remote control assembly 300 for the duration of pairing mode and containing the radio serial number of infusion pump assembly 100, 100', 400, 500.

[0529] The radio of infusion pump assembly 100, 100', 400, 500 may automatically time out of pairing mode after 2.0±0.2 seconds if an RF pairing request is not received. The radio of infusion pump assembly 100, 100', 400, 500 may issue a pairing request received message after transmitting the RF pairing acknowledgement. This message to the supervisor processor allows feedback to the user during the pairing acknowledgement process. The radio of infusion pump assembly 100, 100', 400, 500 may automatically time out of pairing mode after transmitting the RF pairing acknowledgement unless an RF pairing acknowledgement request is received. The radio of infusion pump assembly 100, 100', 400, 500 may issue a store paired radio serial number message if an RF pairing acknowledgement request message is received after receiving the RF pairing request message. This action may store the radio serial number of remote control assembly 300 in non-volatile memory of infusion pump assembly 100, 100', 400, 500 and may overwrite existing pairing data of infusion pump assembly 100, 100', 400, 500.

[0530] The radio of infusion pump assembly 100, 100', 400, 500 may transmit an RF pairing confirmation acknowledgment and exit pairing mode after acknowledgment from the pairing radio serial number storage message is received. This may be a normal exit of pairing mode on infusion pump assembly 100, 100', 400, 500, and may power down infusion pump assembly 100, 100', 400, 500 until placed in connection or pairing mode by the user.

[0531] If the radio of infusion pump assembly 100, 100', 400, 500 exits pairing mode upon successful receipt of the pairing confirmation request message, the radio of infusion pump assembly 100, 100', 400, 500 may return to the newly paired remote control assembly 300 and may send a pairing complete success message to command processor 1802. , may exit pairing mode upon receiving an RF pairing abort message. The radio of infusion pump assembly 100, 100', 400, 500 may exit pairing mode upon receiving a pairing abort request message directed to it. This may allow command processor 1802 or supervisor processor 1800 to abort the pairing process locally on infusion pump assembly 100, 100', 400, 500.

[0532] The radio of remote control assembly 300 may enter pairing mode upon receiving the pairing mode request message. It may be the responsibility of the UI processor of remote control assembly 300 to request that the radio enter pairing mode under appropriate conditions. The radio of remote control assembly 300 may set the appropriate transmit power level for pairing mode. The radio of remote control assembly 300 may transmit the RF pairing request until an RF pairing acknowledgement is received or pairing is aborted.

[0533] The radio of remote control assembly 300 may automatically abort pairing mode if it does not receive an RF pairing acknowledgement message within 30.0±1.0 seconds of entering pairing mode. Upon receiving the first valid RF pairing acknowledgement message while in pairing mode, the radio of remote control assembly 300 may send a pairing success message to the UI processor of remote control assembly 300 including the serial number of infusion pump assembly 100, 100′, 400, 500 and may use that serial number for the duration of pairing mode. This message may provide a means for the UI processor of remote control assembly 300 to prompt the user to confirm the serial number of the desired infusion pump assembly 100, 100′, 400, 500. If the radio of remote control assembly 300 receives multiple responses (for a single pairing request) from infusion pump assembly 100, 100′, 400, 500, the first valid one may be used.

[0534] The radio of remote control assembly 300 may only accept an RF pairing confirmation acknowledgement message after an RF pairing acknowledgement has been received while in pairing mode. The radio of remote control assembly 300 may transmit an RF pairing confirmation message upon receiving a pairing confirmation request message from the UI processor of remote control assembly 300.

[0535] The radio of remote control assembly 300 may check that infusion pump assembly 100, 100', 400, 500 confirms pairing before adding the infusion pump assembly 100, 100', 400, 500 to the pairing list. The radio of remote control assembly 300 may issue a store paired radio serial number message once the RF pairing complete message is received. This action may enable the UI processor of remote control assembly 300 to store the new serial number of infusion pump assembly 100, 100', 400, 500 and provide user feedback of successful pairing. It may be the responsibility of the UI processor of remote control assembly 300 to manage the list of paired infusion pump assemblies.

[0536] The radio of remote control assembly 300 may transmit an RF pairing interrupt request message and exit pairing mode upon receiving the pairing interrupt request message, which may allow the UI processor of remote control assembly 300 to interrupt the pairing process with both remote control assembly 300 and approved infusion pump assembly 100, 100′, 400, 500.

[0537] In connection request mode, the radio of remote control assembly 300 connects to its paired infusion pump. Each infusion pump assembly 100, 100', 400, 500 in the assembly list may be acquired and attempt to retrieve its "ready to connect" status. The "connect" process (schematically depicted in FIG. 120E) may allow the remote control assembly 300 to quickly identify one of its paired infusion pump assemblies, which may be ready to be used. The radio of the remote control assembly 300 may be capable of implementing a connection request mode with up to six paired infusion pump assemblies. The connection request mode may only be supported on the remote control assembly 300 or may be a specialized form of acquisition mode. In the connection request mode, the remote control assembly 300 may connect and respond with the first infusion pump assembly. However, each message may be directed to a specific infusion pump assembly serial number.

[0538] When the radio of the remote control assembly 300 enters connection mode, it may obtain the most recent paired infusion pump assembly serial number. The radio of the remote control assembly 300 may enter connection mode upon receiving a connection mode request message. It may be the responsibility of the UI processor of the remote control assembly 300 to request that the radio enter connection mode when it desires to communicate with a paired infusion pump assembly. The radio of the remote control assembly 300 may issue a connection assessment message to the UI processor of the remote control assembly 300 containing the radio serial number of the first infusion pump assembly that is "ready to connect," if any. The radio of the remote control assembly 300 may generate the connection assessment message within 30 seconds of entering connection request mode. The radio of the remote control assembly 300 may exit connection request mode and transition to fast heartbeat mode upon receiving a connection assessment acknowledgement. The radio of the remote control assembly 300 may exit connection request mode upon receiving a connection request abort message from the UI processor of the remote control assembly 300.

[0539] An acquisition mode may be used on the remote control assembly 300 to find a particular paired infusion pump assembly. The radio of the remote control assembly 300 may send an RF RUT (aRe yoU There) packet to the desired paired infusion pump assembly. The infusion pump assembly may respond to the radio of the remote control assembly 300 if it receives the RF RUT message. Multiple channels may be used in the acquisition mode algorithm to improve the chances that the radio of the remote control assembly 300 will find the paired infusion pump assembly.

[0540] The radio of remote control assembly 300 may enter acquisition mode upon receiving an acquisition mode request or fast heartbeat mode request message while in RF off mode. The radio of remote control assembly 300 may enter synchronization acquisition mode upon receiving an acquisition mode request or fast heartbeat mode request message while in search synchronization mode. It may be the responsibility of the UI processor of remote control assembly 300 to request that the radio enter acquisition mode when the RF link is offline and remote control assembly 300 desires to communicate with infusion pump assembly 100, 100', 400, 500.

[0541] The radio of remote control assembly 300 may only communicate (excluding pairing and connection modes) with one paired infusion pump assembly 100, 100′, 400, 500. If communication is lost, the UI processor of remote control assembly 300 may use acquisition mode (at some periodic rate limited by the power budget) to attempt to restore communication.

[0542] Infusion pump assembly 100, 100', 400, 500 may enter acquisition mode under the following conditions: When in radio off mode, acquisition mode may be required When the search synchronization mode times out due to lack of heartbeat Upon entering acquisition mode, the radio of infusion pump assembly 100, 100', 400, 500 may obtain the serial number of the last stored paired remote control assembly 300. The radio of infusion pump assembly 100, 100', 400, 500 may only communicate with the remote control assembly with which it is "paired" (except while in "pairing request" mode). The radio of infusion pump assembly 100, 100', 400, 500 may transition from acquisition mode to fast heartbeat mode upon successfully acquiring synchronization with remote control assembly 300. The acquisition mode of infusion pump assembly 100, 100', 400, 500 may be capable of acquiring synchronization within 6.1 seconds, which may imply that when in acquisition mode, infusion pump assembly 100, 100', 400, 500 may always be listening at least approximately every 6 seconds.

[0543] Data packets may be transmitted between two paired devices when the two devices are in syn...

Claims

[Claim 1] Benefit from a wearable device.

Images