Infusion pump assembly

Abstract

The present invention relates to an infusion pump assembly. A wearable infusion pump assembly includes a reusable housing assembly including a 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. The wearable infusion pump assembly also includes a disposable housing assembly including a reservoir for receiving an infusible fluid. A releasable engagement assembly is configured to releasably engage the reusable housing assembly with the disposable housing assembly. A switch assembly is configured to enable a pairing function of the infusion pump assembly.

Description

[0001] This application is a divisional application of the Chinese patent application with a filing date of April 25, 2019, application number 201910340716.9, and invention name “Infusion Pump Assembly”.

[0002] The Chinese patent application with application number 201910340716.9 is a divisional application of the Chinese patent application with application number 201410557836.1, filed on October 20, 2014, and invention name “Infusion Pump Assembly”.

[0003] The Chinese patent application with application number 201410557836.1 is a national phase application of the patent application with international application date of December 31, 2008 and international application number PCT / US2008 / 088688, which entered China on August 25, 2010. The Chinese patent application number is 200880127500.4.

[0004] Cross-reference to related applications

[0005] This application claims the benefit of the following provisional patent applications, each of which is incorporated herein by reference in its entirety: USSN 61 / 018054, filed December 31, 2007; USSN 61 / 018042, filed December 31, 2007; USSN 61 / 017989, filed December 31, 2007; USSN 61 / 018002, filed December 31, 2007; USSN 61 / 018339, filed December 31, 2007; USSN 61 / 023645, filed January 25, 2008; USSN 61 / 101053, filed September 29, 2008; USSN 61 / 101077, filed September 29, 2008; and USSN 61 / 101105. Technical Field

[0006] The present application relates generally to fluid delivery systems and, more particularly, to infusion pump assemblies. Background Art

[0007] Many potentially valuable drugs or compounds, including biologics, are not orally active due to poor absorption, hepatic metabolism, or other pharmacokinetic factors. Furthermore, some therapeutic compounds, while orally absorbable, sometimes require too frequent a dose, making it difficult for patients to maintain a desired dosing schedule. In these cases, parenteral delivery is often employed or may be used.

[0008] Effective parenteral routes for drug delivery and other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, involve piercing 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 parenteral medications may benefit from a wearable device that can automatically deliver the desired medication / compound over time.

[0009] 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 are electronically controlled. These devices suffer from numerous drawbacks, including failure rates. Reducing the size, weight, and cost of these devices is also an ongoing challenge. In addition, these devices are often applied to the skin, which poses the challenge of frequent repositioning for application. Summary of the Invention

[0010] According to a first embodiment, a wearable infusion pump assembly includes a reusable housing assembly including a mechanical control assembly comprising a pump assembly, at least one shape memory actuator configured to actuate the pump assembly, and at least one valve assembly. The wearable infusion pump assembly also includes 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 enable a pairing function of the infusion pump assembly.

[0011] According to another embodiment, a wearable infusion pump assembly includes a reusable housing assembly and a disposable housing assembly, the 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 enable functionality of the infusion pump assembly.

[0012] According to another embodiment, a computer program product includes a computer-readable medium including a plurality of instructions stored thereon. When executed by a processor, the instructions cause the processor to perform operations including receiving an activation signal from a switch assembly included in a wearable infusion pump assembly, the activation signal indicating a bolus infusion event. The computer-readable medium also includes instructions for receiving a dosage signal from the switch assembly, the instructions indicating at least a portion of a bolus amount of the infusible fluid. The computer-readable medium also includes instructions for presenting an audible quantity signal on the wearable infusion pump assembly in response to the dosage signal. Additionally, the computer-readable medium includes instructions for receiving an acknowledgement signal from the switch assembly, the acknowledgement signal indicating concurrence of the audible quantity signal.

[0013] According to another embodiment, 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 transmitting a ping signal from a wearable infusion pump assembly to a remote control assembly. The computer-readable medium further includes instructions for monitoring for receipt of a reply signal from the remote control assembly in response to the ping signal. Additionally, the computer-readable medium includes instructions for presenting an audible separation alarm on the wearable infusion pump assembly if the reply signal is not received within a defined time period.

[0014] According to another embodiment, 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 initiation signal from a switch assembly included in a wearable infusion pump assembly, the pairing initiation signal indicating a pairing event. The computer-readable medium further includes instructions for monitoring for receipt of a pairing request from a remote control assembly for the wearable infusion pump assembly. Furthermore, the computer-readable medium includes instructions for providing an acknowledgement message to the remote control assembly if a pairing request is received, wherein the acknowledgement message uniquely identifies the wearable infusion pump assembly.

[0015] According to another embodiment, 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 contiguous region having a volume that varies based on the quantity of the infusible fluid received from the reservoir. The volume sensor assembly also includes an acoustic energy emitter configured to provide acoustic energy at a plurality of frequencies to excite gas contained within the acoustically contiguous region.

[0016] According to another embodiment, 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 device. 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 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 an amount of the infusible fluid to the external infusion device. The computer-readable medium also includes instructions for calculating a second volume characteristic after providing the amount of the infusible fluid to the external infusion device. The computer-readable medium also includes instructions for determining whether an occlusion condition has occurred.

[0017] According to another embodiment, 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 device. 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 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 comprising determining an amount of the infusible fluid delivered to a user via the external infusion device. The computer-readable medium also includes instructions for comparing the amount of the infusible fluid delivered to a target delivery amount to determine a difference. The computer-readable medium also includes instructions for adjusting a subsequently delivered amount of the infusible fluid to compensate for the difference.

[0018] According to another embodiment, 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 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 comprising executing one or more hierarchical state machines to implement one or more bolus infusion events.

[0019] According to another embodiment, 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 comprising executing one or more hierarchical state machines to implement one or more basal infusion events.

[0020] According to another embodiment, 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 implement execution of one or more occlusion detection events.

[0021] According to another embodiment, 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 with 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 implement execution of one or more pairing events.

[0022] According to another embodiment, 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 a filling station including an infusible fluid supply. The filling station is configured to releasably fluidly connect to the reservoir and facilitate delivery of the infusible fluid from the filling station to the reservoir.

[0023] According to another embodiment, 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 a detachable external infusion set configured to deliver the infusible fluid to a user.

[0024] According to another embodiment, a 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 also includes a releasable engagement assembly configured to allow the reusable housing assembly to rotate with the disposable housing assembly.

[0025] According to another embodiment, 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 a bolus switch assembly configured to enable a bolus infusion event.

[0026] According to another embodiment, a wearable infusion pump assembly includes a fluid-free 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 with the disposable housing assembly.

[0027] According to another embodiment, a wearable infusion pump assembly includes a reservoir for receiving an infusible fluid and an external infusion device 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 device. The fluid delivery system includes a volume sensor assembly and a pump assembly configured to extract a quantity of the infusible fluid from the reservoir and provide 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 also includes a second valve assembly configured to selectively isolate the volume sensor assembly from the external infusion device.

[0028] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will become apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a side view of the infusion pump assembly;

[0030] Figure 2 yes Figure 1A perspective view of an infusion pump assembly;

[0031] Figure 3 yes Figure 1 An exploded view of the various components of the infusion pump assembly;

[0032] Figure 4 yes Figure 1 a cross-sectional view of a disposable housing assembly of an infusion pump assembly;

[0033] Figures 5A-5C is a cross-sectional view of an embodiment of a septum access assembly;

[0034] Figures 6A-6B is a cross-sectional view of another embodiment of a septum access assembly;

[0035] Figures 7A-7B is a partial top view of another embodiment of a septum access assembly;

[0036] Figures 8A-8B is a cross-sectional view of another embodiment of a septum access assembly;

[0037] Figure 9 yes Figure 1 a perspective view of an infusion pump assembly showing an external infusion set;

[0038] Figures 10A-10E Several hook and loop fastener configurations are shown;

[0039] Figure 11A is the remote control component and Figure 1 An isometric view of an alternative embodiment of an infusion pump assembly;

[0040] Figures 11B-11R Shows Figure 1 Various views and flow charts of high-level diagrams of infusion pump components;

[0041] Figures 12A-12F is Figure 11A Multiple display screens presented by a remote control component;

[0042] Figure 13 yes Figure 1 An isometric view of an alternative embodiment of an infusion pump assembly;

[0043] Figure 14 yes Figure 13 Isometric view of the infusion pump assembly;

[0044] Figure 15 yes Figure 13 Isometric view of the infusion pump assembly;

[0045] Figure 16 yes Figure 1An isometric view of an alternative embodiment of an infusion pump assembly;

[0046] Figure 17 yes Figure 16 A plan view of an infusion pump assembly;

[0047] Figure 18 yes Figure 16 A plan view of an infusion pump assembly;

[0048] Figure 19A yes Figure 16 An exploded view of the various components of the infusion pump assembly;

[0049] Figure 19B yes Figure 16 an isometric view of a portion of an infusion pump assembly;

[0050] Figure 20 yes Figure 16 a cross-sectional view of a disposable housing assembly of an infusion pump assembly;

[0051] Figure 21 yes Figure 16 a diagram of a fluid path within an infusion pump assembly;

[0052] Figures 22A-22C yes Figure 16 a diagram of a fluid path within an infusion pump assembly;

[0053] Figure 23 yes Figure 16 An exploded view of the various components of the infusion pump assembly;

[0054] Figure 24 yes Figure 16 a cutaway isometric view of a pump assembly of an infusion pump assembly;

[0055] Figures 25A-25D yes Figure 24 Other isometric views of the pump assembly;

[0056] Figures 26A-26B yes Figure 16 an isometric view of a measuring valve assembly of an infusion pump assembly;

[0057] Figures 27A-27B yes Figures 26A-26B A side view of a measuring valve assembly;

[0058] Figures 28A-28D yes Figure 16 a view of a measuring valve assembly of an infusion pump assembly;

[0059] Figure 29 yes Figure 1 An isometric view of an alternative embodiment of an infusion pump assembly;

[0060] Figure 30 yes Figure 1 An isometric view of an alternative embodiment of an infusion pump assembly;

[0061] Figure 31 yes Figure 9 Another view of an alternative embodiment of an infusion pump assembly;

[0062] Figure 32 is an exploded view of another embodiment of an infusion pump assembly;

[0063] Figure 33 yes Figure 32 Another exploded view of the infusion pump assembly;

[0064] Figures 34A-34B Another embodiment of an infusion pump assembly is shown;

[0065] Figures 35A-35C yes Figure 32 a top view, a side view, and a bottom view of a reusable housing assembly of an infusion pump assembly;

[0066] Figure 36 yes Figures 35A-35C an exploded view of a reusable housing assembly;

[0067] Figure 37 yes Figures 35A-35C an exploded view of a reusable housing assembly;

[0068] Figure 38A yes Figures 35A-35C an exploded view of a reusable housing assembly;

[0069] Figures 38B-38D are top, side, and bottom views of one embodiment of a dust cover;

[0070] Figures 39A-39C yes Figures 35A-35C a top view, a side view, and a bottom view of an electrical control assembly of a reusable housing assembly;

[0071] Figures 40A-40C yes Figures 35A-35C a top view, a side view, and a bottom view of a base plate of a reusable housing assembly;

[0072] Figures 41A-41B yes Figures 40A-40C a perspective top view and a perspective bottom view of a substrate;

[0073] Figures 42A-42C yes Figures 35A-35C a top view, a side view, and a bottom view of a base plate of a reusable housing assembly;

[0074] Figures 43A-43B Shows Figures 35A-35C a mechanical control assembly of a reusable housing assembly;

[0075] Figures 44A-44C Shows Figures 35A-35C a mechanical control assembly of a reusable housing assembly;

[0076] Figures 45A-45B Shows Figures 35A-35C The reusable housing assembly includes the pump plunger and reservoir valve of the mechanical control assembly.

[0077] Figures 46A-46E Shows Figures 35A-35C Various views of a pump plunger and a reservoir valve of a mechanical control assembly of a reusable housing assembly;

[0078] Figures 47A-47B Shows Figures 35A-35C a measuring valve of a mechanical control assembly of a reusable housing assembly;

[0079] Figure 48 yes Figure 32 an exploded view of a disposable housing assembly of an infusion pump assembly;

[0080] Figure 49A yes Figure 48 a plan view of a disposable housing assembly;

[0081] Figure 49B It is taken along line BB Figure 49A a cross-sectional view of a disposable housing assembly;

[0082] Figure 49C It is intercepted along the CC line Figure 49A a cross-sectional view of a disposable housing assembly;

[0083] Figures 50A-50C Shows Figure 48 a base of a disposable housing assembly;

[0084] Figures 51A-51C Shows Figure 48 a fluid path cover of a disposable housing assembly;

[0085] Figures 52A-52C Shows Figure 48 A membrane assembly of a disposable housing assembly;

[0086] Figures 53A-53C Shows Figure 48 a top portion of a disposable housing assembly;

[0087] Figures 54A-54C Shows Figure 48 a valve diaphragm insert of a disposable housing assembly;

[0088] Figures 55A-55B Shows Figure 32 a locking ring assembly of an infusion pump assembly;

[0089] Figures 56A-56C Shows Figure 32 a locking ring assembly of an infusion pump assembly;

[0090] Figures 57-58 is an isometric view of the infusion pump assembly and filling connector;

[0091] Figures 59-64 yes Figure 57 Various views of the filling connection;

[0092] Figure 65 is an isometric view of another embodiment of a fill adapter;

[0093] Figures 66-67 Another embodiment of an infusion pump assembly and a filling adapter is shown;

[0094] Figures 68-74 yes Figure 66 Various views of the filling connection;

[0095] Figures 75-80 Various views of an embodiment of a battery charger are shown;

[0096] Figure 81 -89 shows various embodiments of a battery charger / docking station;

[0097] Figures 90A-90C is included in Figure 1 Various views of a volume sensor assembly within an infusion pump assembly;

[0098] Figures 91A-91I is included in Figure 1 Various views of a volume sensor assembly within an infusion pump assembly;

[0099] Figures 92A-92I is included in Figure 1 Various views of a volume sensor assembly within an infusion pump assembly;

[0100] Figures 93A-93I is included in Figure 1 Various views of a volume sensor assembly within an infusion pump assembly;

[0101] Figures 94A-94F is included in Figure 1 Various views of a volume sensor assembly within an infusion pump assembly;

[0102] Figure 95 is included in Figure 1 an exploded view of a volume sensor assembly within an infusion pump assembly;

[0103] Figure 96 is included in Figure 1 an illustration of a volume sensor assembly within an infusion pump assembly;

[0104] Figure 97 yes Figure 96 A two-dimensional graph of performance characteristics of a volume sensor assembly;

[0105] Figure 98 yes Figure 96 A two-dimensional graph of performance characteristics of a volume sensor assembly;

[0106] Figure 99 yes Figure 96 A two-dimensional graph of performance characteristics of a volume sensor assembly;

[0107] Figure 100 is included in Figure 1 an illustration of a volume sensor assembly within an infusion pump assembly;

[0108] Figure 101 yes Figure 100 A two-dimensional graph of performance characteristics of a volume sensor assembly;

[0109] Figure 102 yes Figure 100 A two-dimensional graph of performance characteristics of a volume sensor assembly;

[0110] Figure 103 is included in Figure 1 an illustration of a volume sensor assembly within an infusion pump assembly;

[0111] Figure 104 is included in Figure 1 a two-dimensional graph of performance characteristics of a volume sensor assembly within an infusion pump assembly;

[0112] Figure 105 is included in Figure 1 a two-dimensional graph of performance characteristics of a volume sensor assembly within an infusion pump assembly;

[0113] Figure 106 is included in Figure 1 a two-dimensional graph of performance characteristics of a volume sensor assembly within an infusion pump assembly;

[0114] Figure 107 is included in Figure 1 a two-dimensional graph of performance characteristics of a volume sensor assembly within an infusion pump assembly;

[0115] Figure 108 is included in Figure 1 a two-dimensional graph of performance characteristics of a volume sensor assembly within an infusion pump assembly;

[0116] Figure 109 is used to include Figure 1 a diagram of a control model for a volume sensor assembly within an infusion pump assembly;

[0117] Figure 110 is used to include Figure 1 a diagram of an electrical control assembly of a volume sensor assembly within an infusion pump assembly;

[0118] Figure 111 is used to include Figure 1 an illustration of a volume controller of a volume sensor assembly within an infusion pump assembly;

[0119] Figure 112 yes Figure 111 Illustration of the feedforward controller of the volume controller;

[0120] Figures 113-114 Schematic diagram showing Figure 111 Implementation of the SMA controller of the volume controller;

[0121] Figures 114A-114B It is an alternative implementation of the SMA controller;

[0122] Figure 115 Schematic showing the possible inclusions Figure 1 A multi-processor control structure within an infusion pump assembly;

[0123] Figure 116 Can be included in Figure 1 A diagram of a multi-processor control structure within an infusion pump assembly;

[0124] Figures 117A-117B Schematic showing multiprocessor functionality;

[0125] Figure 118 Schematic showing multiprocessor functionality;

[0126] Figure 119 Schematic showing multiprocessor functionality;

[0127] Figures 120A-120E The diagram shows the various software layers;

[0128] Figures 120B-120C The various state diagrams are shown;

[0129] Figure 120D The diagram shows the device interactions;

[0130] Figure 120E The diagram shows the device interactions;

[0131] Figure 121 The figure shows the contents contained in Figure 1a volume sensor assembly within an infusion pump assembly;

[0132] Figure 122 The figure shows Figure 1 The interconnection of the various systems of the infusion pump assembly;

[0133] Figure 123 The figure shows a basal-bolus infusion event;

[0134] Figure 124 The figure shows a basal-bolus infusion event;

[0135] Figures 125A-125G shows the hierarchical state machine;

[0136] Figures 126A-126M shows the hierarchical state machine;

[0137] Figure 127 is an illustration of a split ring resonator antenna;

[0138] Figure 128 is an illustrative diagram of a medical device configured to use a split ring resonator antenna;

[0139] Figure 129 is an illustration of a split ring resonator antenna and a transmission line from a medical infusion device;

[0140] Figure 130 is a graph of the return loss of a split ring resonator antenna before contact with human skin;

[0141] Figure 130A is a graph of the return loss of a split ring resonator antenna during contact with human skin;

[0142] Figure 131 is an illustration of a split ring resonator antenna integrated into a device operating near a dielectric material;

[0143] Figure 132 is a diagrammatic representation of the interior and exterior dimensions of the illustrated embodiment;

[0144] Figure 133 is a graph of the return loss of a non-slit ring resonator antenna before contact with human skin;

[0145] Figure 133A is a graph of the return loss of a non-slit ring resonator antenna during contact with human skin;

[0146] Like reference numbers refer to like elements throughout the various views. DETAILED DESCRIPTION

[0147] Reference Figure 1-3Infusion pump assembly 100 may include reusable housing assembly 102. Reusable housing assembly 102 may be constructed of any suitable material that resists compression, such as a hard or rigid plastic. For example, the use of durable materials and components may improve quality and reduce costs by providing a longer-lasting and more durable reusable portion, thereby providing greater protection for components disposed therein.

[0148] Reusable housing assembly 102 may include mechanical control assembly 104 having pump assembly 106 and at least one valve assembly 108. Reusable housing assembly 102 may also include electrical control assembly 110 configured to provide one or more control signals to mechanical control assembly 104 and implement basal and / or bolus delivery of an infusible fluid to a user. Disposable housing assembly 114 may include valve assembly 108, which may be configured to control the flow of the infusible fluid through the fluid path. Reusable housing assembly 102 may also include pump assembly 106, which may be configured to pump the infusible fluid from the fluid path to the user.

[0149] Electrical control assembly 110 can monitor and control the amount of infusible fluid that has been pumped and / or is being pumped. For example, electrical control assembly 110 can receive a signal from volume sensor assembly 148 and calculate the amount of infusible fluid currently dispensed, and determine whether sufficient infusible fluid has been dispensed based on the user's desired dose. If insufficient infusible fluid has been dispensed, electrical control assembly 110 can determine that more infusible fluid should be pumped. Electrical control assembly 110 can provide an appropriate signal to mechanical control assembly 104 to pump any additional desired dose, or it can provide an appropriate signal to mechanical control assembly 104 to dispense the additional dose with the next dispensing. Alternatively, if too much infusible fluid has been dispensed, electrical control assembly 110 can provide an appropriate signal to mechanical control assembly 104 to dispense less infusible fluid with the next dispensing.

[0150] The mechanical control assembly 104 may include at least one shape memory actuator 112. The pump assembly 106 and / or the valve assembly 108 of the mechanical control assembly 104 may be actuated by at least one shape memory actuator, such as shape memory actuator 112, which may be a shape memory wire in a wire or spring configuration. The shape memory actuator 112 may be operably connected to and actuated by an electrical control assembly 110, which may control the time and amount of heat and / or electrical energy used to actuate the mechanical control assembly 104. For example, 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 using a heater or, more conveniently, by applying electrical energy. The shape memory actuator 112 may be made of a material such as NITINOL. TM or Shape memory wire composed of nickel / titanium alloy.

[0151] 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 acoustic volume detection. Acoustic volume measurement technology is the subject of U.S. Patent Nos. 5,575,310 and 5,755,683, assigned to DEKA Products Limited Partnership, and U.S. Patent Application Publication Nos. US2007 / 0228071 A1, US2007 / 0219496 A1, US2007 / 0219480 A1, and US2007 / 0219597 A1, all of which are incorporated herein by reference in their entirety. Other alternative techniques for measuring fluid flow may also be used; for example, methods based on the Doppler effect; the use of a Hall effect sensor in combination with a leaf or flapper valve; the use of a strain beam (e.g., a flexible member positioned above a fluid reservoir to sense deformation of the flexible member); the use of capacitive sensing using a plate; and thermal time-of-flight methods. One such alternative technique is disclosed in U.S. patent application Ser. No. 11 / 704,899, filed on 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 the volume measurement generated by volume sensor assembly 148 may be used to control the amount of infusible fluid infused into the user via a feedback loop.

[0152] Infusion pump assembly 100 may also include disposable housing assembly 114. For example, disposable housing assembly 114 may be configured for a single use or for a specified period of time, such as three days or any other amount of time. Disposable housing assembly 114 may be configured such that any components of infusion pump assembly 100 that come into contact with the infusible fluid are disposed on and / or within disposable housing assembly 114. For example, a fluid path or channel 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 being discarded. The disposable nature of disposable housing assembly 114 may improve the sanitation of infusion pump assembly 100.

[0153] In addition, refer to Figure 4 Disposable housing assembly 114 may be configured to releasably engage with reusable housing assembly 102 and include cavity 116 having a reservoir 118 for receiving an infusible fluid (not shown), such as insulin. This releasable engagement may be achieved, for example, by a screw-on, twist-lock, or press-fit configuration. Disposable housing assembly 114 and / or reusable housing assembly 102 may include an alignment assembly configured to help align disposable housing assembly 114 and reusable housing assembly 102 for engagement in a specific orientation. Similarly, base tabs 120 and top tabs 122 may serve as indicators of alignment and complete engagement.

[0154] Cavity 116 may be at least partially formed by and integrally formed with disposable housing assembly 114. Cavity 116 may include a membrane assembly 124 for at least partially defining a reservoir 118. Reservoir 118 may be further defined by disposable housing assembly 114, for example, by a recess 126 formed in a base 128 of disposable housing assembly 114. For example, membrane assembly 124 may be positioned over recess 126 and attached to base 128, thereby forming reservoir 118. Membrane assembly 124 may be attached to base 128 by conventional means, such as gluing, heat sealing, and / or press-fitting, thereby forming a seal 130 between membrane assembly 124 and base 128. Membrane assembly 124 may be flexible, and the space formed between membrane assembly 124 and recess 126 in base 128 may define reservoir 118. Reservoir 118 may be non-pressurized and in fluid communication with a fluid path (not shown). Membrane assembly 124 can be at least partially collapsible and cavity 116 can include a vent assembly to advantageously prevent the formation of a vacuum in reservoir 118 when the infusible fluid is delivered from reservoir 118 to the fluid path. In a preferred embodiment, membrane assembly 124 is fully collapsible, thereby allowing for complete delivery of the infusible fluid. Cavity 116 can be configured to provide sufficient space to ensure that there is always some air space even when reservoir 118 is filled with the infusible fluid.

[0155] The membranes and reservoirs described herein may be made of materials including, but not limited to, silicone, NITRILE, and any other material having the desired elasticity and properties to function as described herein. Additionally, other structures may be used for the same purpose.

[0156] The use of a partially collapsible, non-pressurized reservoir advantageously prevents the formation of air in the reservoir as the fluid in the reservoir is depleted. Air formation in a vented reservoir can prevent fluid from flowing out of the reservoir, particularly if the system is tilted such that an air pocket becomes interposed between the fluid contained in the reservoir and the reservoir's diaphragm. As a wearable device, tilting of the system is expected to occur during normal operation.

[0157] Reservoir 118 is typically sized to accommodate a sufficient supply of insulin for delivery over a period of one or more days. For example, reservoir 118 can accommodate approximately 1.00 to 3.00 ml of insulin. For approximately 90% of potential users, a 3.00 ml insulin reservoir would correspond to approximately a three-day supply. In other embodiments, reservoir 118 can be of any size or shape and can be adapted to accommodate 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 accommodate.

[0158] Disposable housing assembly 114 may include support member 132 ( Figure 3 ), support member 132 is configured to prevent accidental compression of reservoir 118. Compression of reservoir 118 may result in unintended doses of the infusible fluid being forced through the fluid path to the user. In a preferred embodiment, reusable housing assembly 102 and disposable housing assembly 114 may be constructed of rigid materials that are not easily compressed. However, as an additional 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 128. For example, support member 132 may be disposed within cavity 116 and may prevent compression of reservoir 118.

[0159] As described above, cavity 116 may be configured to provide sufficient space to ensure that there is always some air space even when reservoir 118 is filled with infusible fluid. Thus, if infusion pump assembly 100 is accidentally compressed, the infusible fluid will not be forced through cannula assembly 136 (e.g., Figure 9 ).

[0160] The chamber 116 may include a diaphragm assembly 146 ( Figure 3), the septum assembly 146 is configured to allow the reservoir 118 to be filled with an infusible fluid. The septum assembly 146 can be a conventional septum made of rubber or plastic and has a one-way fluid valve configured to allow a user to fill the reservoir 118 from a syringe or other filling device. In some embodiments, the septum 146 can be located above the membrane assembly 124. In these embodiments, the chamber 116 can include a support structure (e.g., Figure 3 132 in the septum, the support structure is used to support the area near the back of the septum to maintain the integrity of the septum seal when a needle introduces an infusible fluid into lumen 116. The support structure can be configured to support the septum while still allowing introduction of a needle for introducing the infusible fluid into lumen 116.

[0161] Infusion pump assembly 100 may include a spill prevention assembly (not shown) that may protrude into cavity 116 , for example, and may prevent spillage of reservoir 118 , for example.

[0162] In some embodiments, reservoir 118 can be configured to be filled multiple times. For example, reservoir 118 can be refilled through septum assembly 146. As the infusible fluid is dispensed to a user, electrical control assembly 110 can monitor the fluid level of the infusible fluid in reservoir 118. When the fluid level reaches a low point, electrical control assembly 110 can provide a signal, such as a light or vibration, to the user indicating that reservoir 118 needs to be refilled. A syringe or other filling device can be used to fill reservoir 118 through septum 146.

[0163] Reservoir 118 can be configured for a single filling. For example, a refill prevention assembly (not shown) can be used to prevent refilling of reservoir 118, allowing disposable housing assembly 114 to be used only once. The refill prevention assembly (not shown) can be a mechanical device or an electromechanical device. For example, a syringe can be inserted into septum assembly 146 to fill reservoir 118, and after a single filling, a shutter can be triggered to cover septum 146, thereby preventing future access to septum 146. Similarly, a sensor can indicate to electronic control assembly 110 that reservoir 118 has been filled once, and after a single filling, the sensor can trigger a shutter to cover septum 146, thereby preventing future access to septum 146. Other devices for preventing refilling can also be used and are considered within the scope of the present disclosure.

[0164] As described above, disposable housing assembly 114 may include septum assembly 146, which may be configured to allow reservoir 118 to be filled with an infusible fluid. Septum assembly 146 may be a conventional septum made of rubber or any other material useful as a septum, or in other embodiments, septum assembly 146 may be a one-way fluid valve made of, but not limited to, plastic or other materials. In various embodiments, including this 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 that may be configured to limit the number of times a user can refill reservoir 118.

[0165] For example and also with reference to Figures 5A-5C In the embodiment shown in FIG. 1 , septum access assembly 152 may include a shutter assembly 154 that may be held in an “open” position by a tab assembly 156 that is configured to fit within a slot assembly 158. Upon penetration of septum 146 by filling syringe 160, shutter assembly 154 may be deflected downwardly, causing tab assembly 156 to disengage from slot assembly 158. Once disengaged, spring assembly 162 may bias shutter assembly 154 in the direction of arrow 164, causing septum 146 to no longer be accessible to the user.

[0166] In addition, refer to Figure 6A , an alternative embodiment septum access assembly 166 is shown in an “open” position. In a similar manner to septum access assembly 152 , septum access assembly 166 includes a shutter assembly 168 and a spring assembly 170 .

[0167] In addition, refer to Figure 6B , an alternative embodiment of the septum access assembly 172 is shown in an "open" position, in which the protrusion 178 can engage with the slot 180. In a manner similar to the septum access assembly 166, the septum access assembly 172 can include a shutter assembly 174 and a spring assembly 176. Once the shutter assembly 172 is moved to the "closed" position (e.g., which can prevent further user access to the septum 146), the protrusion 178 can at least partially engage with the slot 180a. The engagement between the protrusion 178 and the slot 180a can lock the shutter assembly 172 in the "closed" position to restrict tampering and reopening of the shutter assembly 172. The spring protrusion 182 of the shutter assembly 172 can bias the protrusion 178 into engagement with the slot 180a.

[0168] However, in various embodiments, the diaphragm access assembly is not linearly actuated. For example and also with reference to Figures 7A-7B, shows an alternative embodiment of a septum access assembly 184 that includes a shutter assembly 186 configured to pivot about an axis 188. When positioned in the open position (e.g., Figure 7A ), septum 146 is accessible due to alignment of passage 190 (in shutter assembly 186) with passage 192 in, for example, a surface of disposable housing assembly 114. However, in the same manner as septum access assemblies 166, 172, septum 146 is accessible when utilizing filling syringe 160 (see FIG. Figure 6B ) After passing through septum 146, shutter assembly 186 can be deflected in a clockwise manner, causing passage 190 (in shutter assembly 186) to no longer align with passage 192 in, for example, a surface of disposable housing assembly 114, thereby preventing access to septum 146.

[0169] In addition, refer to Figures 8A-8B , an alternative embodiment of a septum access assembly 194 is shown. In a manner similar to septum access assemblies 166 and 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. A filling assembly 202 may be used to fill reservoir 118. Filling assembly 202 may include a shutter biasing assembly 204 configured to bias shutter assembly 196 in the direction of arrow 206, which aligns a passage 208 in shutter assembly 196 with septum 146 and a passage 210 in septum access assembly 194, thereby allowing a filling syringe assembly 212 to pass through septum 146 and fill reservoir 118.

[0170] Infusion pump assembly 100 may include seal assembly 150 ( Figure 3), sealing assembly 150 is 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, for example, by a rotational screw-on engagement, a twist-lock engagement, or a compression engagement, reusable housing assembly 102 and disposable housing assembly 114 can fit tightly together, thereby forming a seal. In some embodiments, a more secure seal may be desired. Therefore, sealing assembly 150 may include an O-ring assembly (not shown). Alternatively, sealing assembly 150 may include an overmolded sealing assembly (not shown). When reusable housing assembly 102 and disposable housing assembly 114 are engaged, the use of an O-ring assembly or an overmolded sealing assembly can provide a more secure seal by providing a compressible rubber or plastic layer between reusable housing assembly 102 and disposable housing assembly 114, thereby preventing penetration of external fluids. In some cases, the O-ring assembly can prevent inadvertent detachment. For example, seal assembly 150 may be a watertight seal assembly, thereby enabling a user to wear infusion pump assembly 100 while swimming, bathing, or exercising.

[0171] In addition, refer to Figure 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, via a fluid path. External infusion set 134 may be disposed adjacent to infusion pump assembly 100. Alternatively, external infusion set 134 may be configured for use remote from infusion pump assembly 100, as will be described in greater detail below. External infusion set 134 may include cannula assembly 136, which may include a needle or disposable cannula 138, and tubing assembly 140. Tubing assembly 140 may be in fluid communication with reservoir 118, for example, via a fluid path, and may be in fluid communication with cannula assembly 138, for example, directly or via cannula interface 142.

[0172] External infusion set 134 can be a tethered infusion set, as discussed above with respect to applications remote from infusion pump assembly 100. For example, external infusion set 134 can be in fluid communication with infusion pump assembly 100 via tubing assembly 140, which can be any length desired by the user (e.g., 3-18 inches). Although infusion pump assembly 100 can be worn on the user's skin with the aid of patch 144, the length of tubing assembly 140 can optionally enable the user to wear infusion pump assembly 100 in a pocket. This can be beneficial for users whose skin is susceptible to irritation due to the application of patch 144. Similarly, wearing and / or securing infusion pump assembly 100 in a pocket may be preferred for users engaging in physical activity.

[0173] In addition to / as an alternative to patch 144, a hook and loop fastener system (e.g., such as provided by Velcro USA, Inc. of Manchester, NH) can be used to make the infusion pump assembly (e.g., infusion pump assembly 100) easy to attach and remove for the user. Thus, patch 144 can be attached to the user's skin and can include an outward-facing hook or loop surface. Additionally, the lower surface of disposable housing assembly 114 can include a complementary hook or loop surface. Depending on the resistance to separation of the particular type of hook and loop fastener system employed, the strength of the hook and loop connection can be made greater than the strength of the adhesive to skin connection. Thus, a variety of hook and loop surface patterns can be used to adjust the strength of the hook and loop connection.

[0174] In addition, refer to Figures 10A-10E , five examples of such hook and loop surface patterns are shown. For illustrative purposes, it is assumed that the entire lower surface of the disposable housing assembly 114 is covered in "loop" material. Thus, by varying the pattern (i.e., the amount) of "hook" material present on the surface of the patch 144, the strength of the hook and loop connection can be adjusted. Examples of these patterns may include, but are not limited to: a single outer circle 220 of "hook" material (e.g., Figure 10A ); multiple concentric circles 222, 224 of "hook" material (as shown in Figure 10B ); multiple radial spokes 226 of "hook" material (as shown in Figure 10C a combination of a plurality of radial spokes 228 of "hook" material and a single outer circle 230 of "hook" material (as shown in Figure 10D and a combination of a plurality of radial spokes 232 of "hook" material and a plurality of concentric circles 234, 236 of "hook" material (as shown in Figure 10E ).

[0175] In addition, also refer to Figure 11A In one exemplary embodiment of the above-described infusion pump assembly, 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 (e.g., wired or wireless) communication between infusion pump assembly 100' and, for example, remote control assembly 300, thereby allowing remote control assembly 300 to remotely control infusion pump assembly 100'. Remote control assembly 300 (which may also include telemetry circuitry (not shown) and be capable of communicating with infusion pump assembly 100') may include display assembly 302 and input assembly 304. Input assembly 304 may include slider assembly 306 and switch assemblies 308 and 310. In other embodiments, the input assembly may include a scroll wheel, a plurality of switch assemblies, etc.

[0176] Remote control assembly 300 may include the ability to pre-program basal rates, bolus alerts, delivery limits, and enable the user to review history and establish user preferences. Remote control assembly 300 may also include a glucose test strip reader.

[0177] 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 communications between remote control assembly 300 and infusion pump assembly 100' may be encrypted to provide an enhanced level of security.

[0178] Communication between remote control assembly 300 and infusion pump assembly 100' may be accomplished using a standard communication protocol. Furthermore, communication between the various components included within infusion pump assembly 100, 100' may be accomplished using the same protocol. One example of such a communication protocol is the Packet Communication Gateway Protocol (PCGP) developed by DEKA Research & Development of Manchester, NH. As described above, infusion pump assembly 100, 100' may include electrical control assembly 110, which may include one or more electrical components. For example, electrical control assembly 110 may include a plurality of data processors (e.g., a supervisor processor and a command processor) and a radio processor for allowing infusion pump assembly 100, 100' to communicate with remote control assembly 300. Furthermore, 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 radio processor for allowing remote control assembly 300 to communicate with infusion pump assembly 100, 100'. A high-level diagram of an example of such a system is shown in FIG. Figure 11B Displayed in.

[0179] Each of these electrical components may be manufactured by a different component supplier and therefore may use inherent (ie unique) communication commands. Thus, through the use of a standardized communication protocol, efficient communication between these different components may be achieved.

[0180] PCGP may be a flexibly extensible software module that may be used on the processors within infusion pump assembly 100, 100' and remote control assembly 300 to establish and route packets. PCGP may abstract various interfaces and may provide a unified application programming interface (API) for various applications executing on each processor. PCGP may also provide suitable interfaces for various drivers. For illustrative purposes only, for any given processor, PCGP may have Figure 11C The conceptual structure shown in .

[0181] PCGP ensures data integrity by using a cyclic redundancy check (CRC). PCGP also provides guaranteed delivery status. For example, all new messages should have an acknowledgment. If this acknowledgment is not sent back in a timely manner, the message may time out and PCGP may generate a negative acknowledgment message (i.e., NACK) for the application. Thus, the message acknowledgment protocol lets the application know whether it should try to send the message again.

[0182] PCGP can also limit the number of in-flight messages from a given node and can be combined with driver-level flow control mechanisms to provide a deterministic approach to message delivery and allow individual nodes to have different amounts of buffers without dropping packets. When a node runs out of buffers, the driver can provide back pressure to other nodes and prevent new messages from being sent.

[0183] PCGP can use a shared buffer pool strategy to minimize data duplication and avoid mutual exclusion, which may have a small impact on the API used to send / receive messages to applications but a larger impact on drivers. PCGP can use a "Bridge" base class that provides routing and buffer ownership. The main PCGP class can be a subclass of the Bridge base class. Drivers can inherit from the Bridge class, or communicate with or own the inherited Bridge class.

[0184] PCGP can be designed to work in embedded environments with or without an operating system by using semaphores to protect shared data, making some calls reentrant and running in multiple threads. An illustrative example of this implementation is in Figure 11D PCGP may run the same way in both environments, but may have different versions of calls for specific processor types (e.g., ARM 9 / OS versions). So while the functionality may be the same, there may be an operating system abstraction layer with slightly different calls appropriate for, for example, an ARM 9 Nucleus OS environment.

[0185] In addition, refer to Figure 11E , PCGP can:

[0186] Allow multiple send / reply calls to occur (on Pilot's ARM 9, with multi-tasking reentrancy)

[0187] ● Have multiple drivers running asynchronously for RX and TX on different interfaces; and

[0188] ● Provides packet ordering for sending / receiving, and deterministic timeouts for message sending.

[0189] Each software object can request the next buffer to use from the buffer manager, which can then offer this buffer to another object. Buffers can be autonomously passed from one dedicated owner to another, and queues automatically occur by sorting buffers by sequence number. When a buffer is no longer in use, it can be recycled (e.g., an object attempts to offer it to itself, or releases it for later reallocation by the buffer manager). Therefore, data typically does not need to be copied; routing simply overwrites the buffer ownership byte.

[0190] This implementation of PCGP may provide various benefits, examples of which may include, but are not limited to:

[0191] Dropping messages due to lack of buffers may not be possible because once a message is placed in a buffer, it remains there until it is transmitted or received by the application;

[0192] There may be no need to copy data because offsets are used to access the driver, PCGP, and payload portions of the buffer.

[0193] The driver can exchange the ownership of the message data by overwriting one byte (the buffer ownership byte);

[0194] ● Mutual exclusion may not be needed except for reentrant calls, because mutual exclusion may only be needed when a single buffer owner wants to use the buffer or obtain a new sequence number simultaneously;

[0195] Application writers have fewer rules to follow to implement reliable systems.

[0196] The driver can use the ISR / push / pull and polling data models, as there is a set of calls from the driver that provide for pushing / pulling data from the buffer management system;

[0197] The driver may not do much work beyond TX and RX, as the driver may not copy, CRC, or check anything except the destination bytes, and the CRC and other checks can be done later, off the ISR hot path;

[0198] • Queue sorting can occur automatically because the buffer manager can sort accesses by sequence number; and

[0199] ● Small code / variable footprint can be used; hot path code can be small and overhead can be low.

[0200] like Figure 11FAs shown in , when a message needs to be sent, PCGP can quickly build a packet and insert it into the buffer management system. Once in the buffer management system, the call to "packetProcessor" can apply the protocol rules and the message can be provided to the driver / application.

[0201] To send a new message or send a reply, PCGP can:

[0202] Check the call arguments to ensure, for example, that the packet length is legal, the destination is appropriate, etc.

[0203] Avoid attempting to send messages across a down link unless the down link is a radio node, which can allow the radio processor to use PCGP to establish links, pairing, etc., and can notify the application when PCGP attempts to talk across a down link (rather than timing out);

[0204] ● Obtain a sequence number for a new message, or use an existing sequence number for an existing message;

[0205] • Build the packet, copy the payload data, and write to the CRC, where (from this point forward) packet integrity can be protected by the CRC; and

[0206] - Provide the message to the buffer manager as a reply or as a new message and check whether placing this buffer in the buffer manager would exceed the maximum number of queued send messages.

[0207] In addition, refer to Figures 11G-11H In other words, PCGP can run by doing all the main work on one thread to avoid mutual exclusion and avoid doing a lot of work on send / reply or driver calls. The "packetProcessor" call may need to apply protocol rules to replies, newly sent messages, and received messages. Reply messages can be simply routed, but new and received messages may have rules for routing messages. In each case, the software can loop when the correct type of message is available to apply the protocol rules until it can no longer process the packet.

[0208] Sending new messages follows the following rules:

[0209] ● Only two messages may be allowed "in flight" on the network; and

[0210] • Sufficient data about in-flight messages can be stored to match responses and handle timeouts.

[0211] Receiving messages can follow the following rules:

[0212] A matching response clears the "in-flight" slot so that a new packet can be sent.

[0213] ●Can discard unmatched responses;

[0214] New messages are available for the protocol (e.g., get / clear network statistics for this node);

[0215] To receive messages, the buffer can be given to the application and callbacks can be used; and

[0216] ●The buffer can be released or retained as owned by the application.

[0217] Therefore, PCGP can be configured so that:

[0218] The callback function can copy the payload data out or use it completely before returning;

[0219] The callback function owns the buffer and can reference the buffer and the buffer's payload via the payload address, where the message can then be processed.

[0220] ● The application can poll the PCGP system for incoming messages; and

[0221] ●Applications can use callbacks to set events and then poll for incoming messages.

[0222] The communication system may have a finite number of buffers. When PCGP runs out of buffers, the driver may stop accepting new packets and the application may be informed that the application cannot send new packets. To avoid this situation and maintain optimal performance, the application may try to perform one or more steps, examples of which include but are not limited to:

[0223] a) Applications should keep PCGP up to date with the latest radio status: Specifically, if the link becomes down and PCGP is unaware of it, PCGP may accept new messages and queue them for sending (or preferably not time out messages), which may clog the send queue and delay the application from using the link optimally.

[0224] b) Applications should call "decrement timeouts" regularly: optimally, every 20-100 milliseconds, unless the processor is asleep. Typically, messages move quickly (milliseconds), slowly (seconds), or not at all. The timeout is an attempt to remove "in-flight" messages that should be lost to free up buffers and bandwidth. Doing so less frequently will delay when new messages are sent or when the application can queue new messages.

[0225] c) The application should ask PCGP if it has pending work to do before going to sleep: if PCGP does not have any work to do, driver activity can wake up the system and therefore PCGP, and then PCGP will not need to call "packetProcessor" or "decrement timeouts" until new packets come in. Failure to do so may result in messages that should have been successfully sent / forwarded / received being dropped due to a timeout condition.

[0226] d) Applications should not hold onto received messages indefinitely: The messaging system relies on immediate acknowledgments. If applications share PCGP buffers, holding onto messages means occupying the PCGP buffer. The receiving node does not know whether the sending node has a timeout configured for slow or fast radio. This means that when a node receives a message, it should assume the network's fast timeout speed.

[0227] e) The application should call "packetProcessor" frequently: this call causes new messages to be queued by the application for sending and can handle the receipt of new messages. The call may also cause buffer reallocations and calling it infrequently may delay message transmission.

[0228] like Figure 11I As shown in , at some point, the RX driver may be requested 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 an available buffer to store the new message. The driver may then request a buffer pointer and begin filling the buffer with the received data. When the complete message is received, the RX driver may call a function to route the packet. The routing function may examine the destination byte in the packet header and may change the owner to another driver or application, or may detect that the packet is bad and discard it by freeing the buffer.

[0229] The PCGP RX overhead may include requesting the next available buffer and calling a routing function. An example of code that performs this function is as follows:

[0230]

[0231] The driver can perform a TX by requesting a pointer to the next buffer to be sent from the buffer manager. The TX driver can then ask the other side of the interface whether it can accept the packet. If the other side rejects the packet, the TX driver can do nothing with the buffer, leaving its state unchanged. Otherwise, the driver can send the packet and reuse / free the buffer. An example of code that implements this function is as follows:

[0232]

[0233]

[0234] To avoid forwarding packets that exceed the maximum message system timeout, the requester for the next buffer calls the BufferManager::first(uint8 owner) function, which scans for buffers to be released. Thus, a full TX buffer with no hope of expiring can be released by the owning thread. Before accepting the next TX buffer for processing, the TX bridge (i.e., while searching for the next TX buffer) can release all expired TX buffers.

[0235] like Figures 11J-11L As shown in , during the buffer allocation process, buffers marked free can be delivered to the driver to receive new packets, or to PCGP to receive new payloads for TX. Allocation from "free" can be performed by the "packetProcessor" function. The number of sends and receives between "packetProcessor" calls can dictate how many LT_Driver_RX, GT_Driver_RX, and PCGP_Free buffers need to be allocated. LT_Driver can represent a driver that handles addresses less than the node address. GT_Driver can represent a driver that handles addresses greater than the node address.

[0236] When the driver receives a packet, the driver can place the data into the RX buffer, which is handed to the router. The router can then reassign the buffer to PCGP_Receive or another driver's TX (not shown). If the buffer clearly contains invalid data, the buffer can be converted to free.

[0237] After the router marks the buffer for TX, the driver can find that the buffer is TX and can send the message. After sending the message, the buffer can immediately become an RX buffer if the driver is low in the RX buffer, or the buffer can be released for reallocation.

[0238] During the "packetProcessor" call, PCGP processes all buffers marked as PCGP_Receive by the router. At this point, the data can be processed, thereby checking the CRC and other data items. If the data is corrupted, statistics can be accumulated and the buffer can be freed. Otherwise, the buffer can be marked as owned by the application. Buffers marked as owned by the application can be reused for PCGP use or released for reallocation by the buffer manager.

[0239] When an application wants to send a new message, it can be done in a reentrant / mutex friendly manner. If a buffer could be allocated, PCGP can mark it as busy. Once marked busy, other threads calling the send or reply function cannot preempt this buffer because it is owned by the invocation of this function call. Error checking and the rest of the message construction can be done outside the isolated race condition mutex protected code. The buffer can be converted to free or can be changed to a valid filled CRC checked buffer and passed to the router. These buffers may not be routed immediately but can be queued so that the message can be sent later (assuming the protocol rules allow it). Reply messages can be marked differently from newly sent messages because reply messages can be routed with a higher priority than normal send messages and reply messages may not have rules limiting how much they can be sent or when they can be sent.

[0240] PCGP is designed to work with flow control, and flow control can negotiate the delivery of messages from one node to another so that buffers are no longer dropped due to a lack of buffers on the other side of the interface (which can cause back pressure on the sending node).

[0241] Flow control can be separated from the shared buffer format. The first two bytes can be reserved for the driver so that the driver does not need to shift the packet bytes. Two bytes can be used so that one byte is the DMA length - 1 and the second byte controls the flow of the message. If the PCGP message is transmitted over RS232, these same two bytes can be the synchronization bytes.

[0242] When a packet is "in flight," the packet may be in the process of being sent by a driver on its way to its destination, being processed by that destination, or being sent back in response.

[0243] Typical delays are:

[0244] Interface / Delay Cause Delay (seconds) Notes SPI <3 About 400kbps I2C <1 Wake up CC2510 <6 Clock adjustment, minutes. Sleep time Flow Control <0.2 RF Link 20 to 2000 Interference / Separation Minutes, never

[0245] Thus, messages tend to complete the round trip quickly (eg, <50ms), slowly (eg, one or more seconds), or not at all.

[0246] PCGP can use two different times for all timeouts (set at initialization), one for when the RF link is in fast heartbeat mode and another for when the RF link is in slow mode. If a message is in flight and the link state changes from fast to slow, the timeout can be adjusted and the difference between fast and slow can be added to the time-to-live counter for the packet. No additional round-tripping will affect the time-to-live for the message.

[0247] There is a second timeout, which can be twice as long as the slow timeout, that is used to monitor buffer allocation within PCGP. Therefore, if a message is "stuck" within the driver and not sent, for example due to flow control or hardware failure, the buffer can be freed by the buffer manager, causing it to be discarded. For a "new" message, this may mean that the packet has timed out and a reply has been given to the application stating that the message was not delivered, causing the buffer to be freed. As the driver polls the buffer manager for buffers that need to be sent, the buffer is freed, allowing the driver to deliver the message that can be sent the next time the driver is unblocked. For reply messages, the reply can simply be discarded, and the sending node can time out.

[0248] The PCGP messaging system can transmit messages that contain header information and a payload. Outside of PCGP, the header can be a set of data items in a call signature. However, within PCGP, a consistent, driver-friendly byte layout is possible. Drivers can insert bytes into or before PCGP packets:

[0249] DE, CA: Synchronization bytes used with RS232, nominal values ​​0xDE, 0xCA or 0x5A, 0xA5.

[0250] ●LD: Driver DMA length byte, equal to the amount the driver is pushing in this DMA transfer, which is the total size not including the size byte or sync byte.

[0251] ●Cmd: Driver command and control byte used for flow control.

[0252] LP: PCGP packet length, which is always the total header + payload size in bytes + CRC size. LD = LP + 1.

[0253] Dst: Destination address

[0254] Src: source address

[0255] ●Cmd: command byte

[0256] Scd: Subcommand byte

[0257] AT: The application tag is defined by the application and is irrelevant to PCGP. It allows the application to attach more information to the message, such as the thread from which the message originated.

[0258] ●SeqNum: A 32-bit sequence number, incremented by PCGP for each new message sent. This ensures that the sequence number will not be wrapped. It is used as a marker; the byte order is irrelevant.

[0259] ●CRC16: Sixteen-bit CRC of the PCGP header and payload.

[0260] An example of a message with no payload, cmd=1, and subcmd=2 is as follows:

[0261] 0xDE,0xCA,0xC,0x5,0x14,1,2,0,0,0,0,0x1,crchigh,crclow.

[0262] 0x0D,cmd,0xC,0x5,0x14,1,2,0,0,0,0,0x1,crchigh,crclow.

[0263] This approach may have several advantages, examples of which may include, but are not limited to:

[0264] • Most of our hardware DMA engines can use the first byte to define how many additional bytes to move, so in this approach the driver and PCGP can share the buffer.

[0265] • A byte may be provided just after the DMA length to carry flow control information between drives.

[0266] ●The drive length and "Cmd" bytes can be outside the CRC area so they can be changed by the drive, can be owned by the drive transport mechanism, and the drive can protect invalid lengths.

[0267] • A separate PCGP packet length byte may be provided with CRC protection. Thus, the application can be confident that the payload length is correct.

[0268] - The byte order of the serial number may be irrelevant, since it is just a matchable pattern of bytes which also happens to be a thirty-two bit integer.

[0269] • The sequence number may be four bytes aligned to the edge of the shared buffer pool length.

[0270] ●Can have an optional RS232 synchronization byte, allowing the user to move the cable while debugging the message flow and have both sides of the interface resynchronize.

[0271] ●Applications, drivers, and PCGP can share buffers and release them through pointers.

[0272] PCGP is not an event-driven software design, but it can be used in an event-driven architecture by how the subclasses are written. Data can be conceptually exchanged between classes (e.g. Figures 11M-11N ).

[0273] Some event model in the driver may wake up the driver, may receive the message, and may pass the message through the bridge into the buffer manager, which routes the message to the new owner of the new message (through the bridge to the driver or PCGP).

[0274] Some example events are summarized below:

[0275]

[0276] The following illustrative example shows how the PCGP event model can be used with Nucleus to wake up the PCGP task after decTimeout for each message sent, acknowledged, or NACKed:

[0277]

[0278]

[0279] Below is an event-based pseudocode driver that shows how driver events work. This driver subclasses Bridge and overrides hasMessagesToSend and flowControlTurnedOff to schedule the TX and RX functions to run if they are not already running.

[0280]

[0281]

[0282]

[0283] The following statistics are supported through PCGP:

[0284] ●The number of packets sent;

[0285] ●The number of packets received;

[0286] CRC error;

[0287] ● Timeout; and

[0288] ●Buffer is not available (buffer exhausted)

[0289] PCGP can be designed to run in multiple processing environments. Most parameters are runtime configurable, which facilitates testing and allows for arbitrary runtime tuning of performance. Other parameters may be compile-time; for example, anything that changes memory allocation must be done statically at compile time.

[0290] The following are compile-time configuration #defines that change where PCGP is implemented:

[0291] • #Driver Bytes: These may be two bytes reserved for drivers in a common buffer scheme, but this may be a compile time option to accommodate other drivers, such as the RF protocol.

[0292] • #RX Driver Buffers: Can be tuned for how many buffers are good for this processor / communication traffic etc.

[0293] • #PCGP RX Buffers: Can be tuned for how many buffers are good for this processor / traffic flow etc.

[0294] ●Total # of buffers: This setting allows you to adjust how many buffers should be allocated to this processor.

[0295] CRC can be used to ensure data integrity. If the CRC is invalid, it may not be delivered to the application and CRC errors may be tracked. The message may eventually time out and may be retried by the originator.

[0296] Likewise, if the messaging system notifies the application that a message was delivered when none was, this could be detrimental to the system. A Stop Bolus Command is an example of such a command. This can be mitigated by a request / action sequence for the message, which the application may need to change therapy. The controller can receive a matching command from the pump application to account for the delivered message.

[0297] DEKA can provide a reference method for integrating PCGP into Nucleus OS system on ARM 9 (such as Figure 11O ).

[0298] like Figure 11P As shown in the , the pcgpOS.cpp file can instantiate PCGP node instances (Pcgp, Bridge, etc.) and provide a set of 'C' connectable function calls through pcgpOS.h, which provide a 'C' language interface to C++ code. This can simplify the 'C' code because the objects being acted upon are implicit.

[0299] The following general rules apply:

[0300] PCGP can run on all nodes: any driver can support the universal driver interface.

[0301] ●Competition conditions may not be allowed.

[0302] ●Can support half-duplex communication on the SPI port between the slave processor and the master processor.

[0303] ●The data transfer may not be attempted; since it will either succeed or return failure / error.

[0304] ● May require low overhead (wasted time, processing, bandwidth)

[0305] ●Can support CC2510 running at DMA (fast) SPI clock rate.

[0306] SPI flow control can prevent data from being sent if the receiving side currently has no empty buffer to place the packet. This can be achieved by requesting permission to send and waiting for a response indicating that you have permission to do so. There can also be a way to inform the other side that there are currently no free buffers and that the transmission should be attempted at a later time.

[0307] All transmissions may begin with a length byte that indicates the number of bytes to be sent, excluding the length byte itself. Following the length may be a single byte that indicates the command being sent.

[0308] The actual transmission of a packet may be the length of the packet plus one byte length for the command byte, followed by the command byte for the attached message, and finally the packet itself.

[0309] In addition to the command bytes being sent, an additional hardware line called the FlowControl line is added to the traditional four SPI signals. The purpose of this line is to allow the protocol to run as quickly as possible without requiring preset delays. Furthermore, it allows the slave processor to inform the master processor that it has packets waiting to be sent, eliminating the need for the master processor to poll the slave processor for status.

[0310] The following example command values ​​may be used:

[0311] Commands to be sent by the host processor

[0312] Order value describe M_RTS 0xC1 Host requests to send packet M_MSG_APPENDED 0xC2 Host sends packet M_CTS 0xC3 The master tells the slave that it is allowed to send M_ERROR 0xC4 Encountered an error state

[0313] The command to be sent from the processor

[0314] Order value describe S_PREPARING_FOR_RX 0xA1 The slave prepares DMA to receive packets S_RX_BUFF_FULL 0xA2 The slave currently lacks RX buffer, try again later S_MSG_APPENDED 0xA3 Slave sends packet S_ERROR 0xA4 Encountered an error state

[0315] like Figure 11QAs shown in , when a slave processor has a packet to send to the master processor, the slave processor can notify the master processor (by asserting the flow control line) that it has a pending packet waiting to be sent. Doing so can generate an IRQ on the master processor, at which point the master processor can decide when to retrieve the message from the slave processor. Retrieving the packet can be delayed by the master processor itself, and the master processor can even decide to attempt to send a packet to the slave processor before retrieving it from the slave processor.

[0316] The master processor can start the retrieval by sending an M_CTS command to the slave processor; this will be repeated until the slave processor responds by sending an S_MSG_APPENDED command along with the packet itself. After the packet has been sent, the FlowControl line can be enabled. If an M_CTS command is received by a slave processor when it is not expecting it, it can be ignored.

[0317] like Figure 11R As shown in , when the master processor has a packet to send to the slave processor, the master processor can initiate the transfer by sending an M_RTS command. After receiving the M_RTS command, if the slave processor currently has a pending transmit packet, the slave processor will lower the FlowControl line so that it can be used again as a clear-to-send signal. The slave processor can then inform the master processor that it is in the process of preparing the SPIDMA to receive a packet, during which time the master processor can stop clocking bytes on the bus and allow the slave processor to complete its preparations for reception.

[0318] The slave processor may then indicate that it is ready to receive the complete packet by raising the FlowControl line (which now acts as the CTS signal).After receiving the CTS signal, the master processor may then send an M_MSG_APPENDED command along with the packet itself.

[0319] After the transfer is complete, the slave processor may lower the FlowControl line. If a packet was pending when the transfer started, or a send occurred on the slave processor while a packet was being received, the slave processor may reassert the FlowControl line, which now indicates that it has a pending packet.

[0320] Refer again Figure 11A , infusion pump assembly 100, 100' may include an electrical control assembly 110 ( Figure 3), electrical control assembly 110 may allow a user (not shown) to perform at least one task, and in some embodiments, multiple tasks. One illustrative example of such a task is managing a bolus dose of an infusible fluid (e.g., insulin) without using a display assembly. Remote control assembly 300 may enable a user to enable / disable / configure infusion pump assembly 100, 100' to manage a bolus dose of insulin.

[0321] In addition, refer to Figure 12A , the slider component 306 can be configured, at least in part, to enable a user to manipulate menu-based information presented on the display component 302. An example of the slider component 306 can include a capacitive slider component that can be implemented using a CY8C21434-24LFXIPSOC provided by Cypress Semiconductor of San Jose, California, the design and operation of which are described in the "CSD User Module" published by Cypress Semiconductor. For example, via the slider component 306, a user can slide their finger in the direction of arrow 314, resulting in the main menu 350 ( Figure 12A Alternatively, the user can slide his finger in the direction of arrow 316, causing the highlighted portion of the information included in the main menu 350 presented on the display component 302 to scroll downward.

[0322] The slider assembly 306 can be configured such that the speed at which, for example, the highlighted portion of the main menu 350 scrolls "up" or "down" changes depending on the position of the user's finger relative to the origin 320. Thus, if the user wishes to scroll "up" quickly, the user can position their finger near the top of the slider assembly 306. Similarly, if the user wishes to scroll "down" quickly, the user can position their finger near the bottom of the slider assembly 306. Additionally, if the user wishes to scroll "up" slowly, the user can position their finger slightly "up" relative to the origin 320. Furthermore, if the user wishes to scroll "down" slowly, the user can position their finger slightly "down" relative to the origin 320. Once the appropriate menu item is highlighted, the user can select the highlighted menu item via one or more of the switch assemblies 308, 310.

[0323] In addition, refer to Figures 12B-12FFor illustrative purposes, assume that infusion pump assembly 100, 100' is an insulin pump and that the user wishes to configure infusion pump assembly 100, 100' so that when the user presses switch assembly 318, a 0.20 unit insulin bolus dose is administered. 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 (e.g., Figure 12B ).

[0324] The user may then use slider assembly 306 to highlight "Manual Bolus" within submenu 352 and may select "Manual Bolus" using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then present submenu 354 on display assembly 302 (e.g., Figure 12C ).

[0325] The user may then use slider assembly 306 to highlight "Bolus: 0.0 units" within submenu 354 and may select "Bolus: 0.0 units" using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then present submenu 356 on display assembly 302 (e.g., Figure 12D ).

[0326] The user may then use slider assembly 306 to adjust the amount of insulin for the "bolus" to "0.20 units," which may be selected using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then present submenu 358 on display assembly 302 (e.g., Figure 12E ).

[0327] User 14 may then highlight "Confirm" using slider assembly 306, which may be selected using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then generate appropriate signals, which may be sent to the aforementioned telemetry circuitry (not shown) included within remote control assembly 300. The telemetry circuitry (not shown) included within the remote control assembly may then transmit appropriate configuration commands via wireless communication channel 312 established between remote control assembly 300 and infusion pump assembly 100' to configure infusion pump assembly 100' to administer a 0.20 unit bolus dose of insulin when the user depresses switch assembly 318.

[0328] Once the appropriate command is successfully transmitted, processing logic (not shown) within remote control assembly 300 may again present submenu 350 on display assembly 302 (e.g., Figure 12F).

[0329] Specifically, and once programmed via remote control assembly 300, the user may depress switch assembly 318 of infusion pump assembly 100' to administer the aforementioned 0.20 unit bolus dose of insulin. Via the aforementioned menu system included within remote control assembly 300, the user may define the amount of insulin to be administered each time the user depresses switch assembly 318. While the specific example specifies that a single depression of switch assembly 318 is equivalent to 0.20 units of insulin, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other values ​​(e.g., 1.00 units of insulin per depression) are equally applicable.

[0330] For illustrative purposes, assume that a user wishes to administer a 2.00 unit bolus dose of insulin. To activate the bolus dose administration system described above, the user may need to press and hold switch assembly 318 for a defined period of time (e.g., five 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). Following 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 press switch assembly 318 the first time, and infusion pump assembly 100, 100' may respond with a confirmation beep, thereby indicating to the user that infusion pump assembly 100, 100' has received the command for (in this particular example) 0.20 units of insulin. Since the desired bolus dose is 2.00 units of insulin, the user may repeat this procedure nine more times to complete the 2.00 unit bolus dose, with infusion pump assembly 100 , 100 ′ generating a confirmation beep after each depression of switch assembly 318 .

[0331] Although in this particular example, infusion pump assembly 100, 100' is described as providing a beep each time the user presses switch assembly 318, this is merely for illustrative purposes 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 defined amount of insulin. As described above, a single press of switch assembly 318 may be equivalent to 0.20 units of insulin. Therefore, infusion pump assembly 100, 100' may be configured to provide a single beep for each 0.10 unit of insulin. Therefore, if infusion pump assembly 100, 100' is configured so that a single press of switch assembly 318 is equivalent to 0.20 units of insulin, then each time switch assembly 318 is pressed, infusion pump assembly 100, 100' may provide the user with two beeps (i.e., once for each 0.10 unit of insulin).

[0332] Once the user has pressed switch assembly 318 on infusion pump assembly 100' a total of ten times, the user may simply wait for infusion pump assembly 100, 100' to confirm receipt of the instruction to administer a 2.00 unit bolus dose of insulin (as opposed to receiving a confirmation beep each time switch assembly 318 is pressed). Once a defined period of time has elapsed (e.g., two seconds), infusion pump assembly 100, 100' may provide the user with an audible confirmation of the number of units to be administered via the bolus insulin dose that the user just requested. For example, if (in this example) the user has programmed infusion pump assembly 100, 100' so that a single press of switch assembly 318 is equivalent to 0.20 units of insulin, infusion pump assembly 100, 100' may emit ten beeps (i.e., 2.00 units is ten 0.20 unit doses).

[0333] When providing feedback to the user regarding the unit amount to be administered via the bolus insulin dose, infusion pump assembly 100, 100' may provide a multi-frequency audible confirmation. For example, and continuing with the above example of providing ten beeps to the user, infusion pump assembly 100, 100' may group the beeps into groups of five beeps each (to facilitate easy counting by the user) and the beeps within each group of five beeps may be provided by infusion pump assembly 100, 100' such that each subsequent beep has a higher frequency than the previous beep (in a manner similar to a musical scale). Thus, and continuing with the above example, infusion pump assembly 100, 100' may provide a 1000 Hz beep, followed by a 1100 Hz beep, followed by a 1200 Hz beep, followed by a 1300 Hz beep, followed by a 1400 Hz beep (thus completing a set of five beeps), followed by a brief pause, then a 1000 Hz beep, followed by a 1100 Hz beep, followed by a 1200 Hz beep, followed by a 1300 Hz beep, followed by a 1400 Hz beep (thus completing a second set of five beeps). According to various additional / alternative embodiments, the multi-frequency audible confirmation may utilize a varying number of tones of increasing frequency. For example, one embodiment may utilize twenty different tones of increasing frequency. However, the number of tones should not be considered a limitation of the present disclosure, as the number of tones may vary based on design criteria and user needs.

[0334] Once infusion pump assembly 100, 100' completes providing the multi-frequency audible confirmation (i.e., the ten beeps described above), the user may depress switch assembly 318 within a defined period of time (e.g., two seconds) to provide a confirmation signal to infusion pump assembly 100, 100' indicating that the multi-frequency audible confirmation is correct and indicating 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 provide an audible tone stating "Confirmation Received" and complete the delivery of the 2.00 unit bolus dose of insulin (in this particular example). If infusion pump assembly 100, 100' does not receive the aforementioned confirmation signal, infusion pump assembly 100, 100' may provide an audible tone stating "Confirmation Failed" and may not complete the delivery of the bolus dose of insulin. Therefore, if the multi-frequency audible confirmation is inaccurate / does not indicate the size of the bolus dose of insulin to be administered, the user may simply not provide the aforementioned confirmation signal, thereby canceling the delivery of the bolus dose of insulin.

[0335] As described above, in one exemplary embodiment of the aforementioned infusion pump assembly, infusion pump assembly 100' can be configured to communicate with remote control assembly 300. When using remote control assembly 300, infusion pump assembly 100' and remote control assembly 300 may periodically contact each other to ensure that the two devices are still in communication. For example, infusion pump assembly 100' may "ping" remote control assembly 300 to ensure that remote control assembly 300 is present and active. Furthermore, remote control assembly 300 may "ping" infusion pump assembly 100' to ensure that infusion pump assembly 100' is still present and active. If one of infusion pump assembly 100' and remote control assembly 300 fails to establish communication with the other, the component unable to establish communication may issue a "detached" alarm. For example, suppose remote control assembly 300 is left in a user's car while infusion pump assembly 100' is in the user's pocket. Consequently, and after a defined period of time, infusion pump assembly 100' may begin to issue a "detached" alarm, indicating that communication with remote control assembly 300 cannot be established. Using switch assembly 318, the user can acknowledge / silence the "detach" alarm.

[0336] Because the user may define and administer a bolus insulin dose 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 dose in a log file (not shown) stored within infusion pump assembly 100'. This log file (not shown) may be stored within non-volatile memory (not shown) included within infusion pump assembly 100'. After communication is reestablished between infusion pump assembly 100' and remote control assembly 300, infusion pump assembly 100' may provide the information regarding the administered bolus insulin dose stored in the log file (not shown) of infusion pump assembly 100' to remote control assembly 300.

[0337] Furthermore, if the user anticipates separating remote control assembly 300 from infusion pump assembly 100', the user (via the menu system described above) may configure infusion pump assembly 100' and remote control assembly 300 to be in "separate" mode, thereby avoiding the occurrence of the "separate" alarm described above. However, the devices may continue to "ping" each other, such that when they are back in communication with each other, infusion pump assembly 100' and remote control assembly 300 may automatically exit "separate" mode.

[0338] Furthermore, if the user anticipates traveling on an airplane, the user (via the above-described menu system of remote control assembly 300) may configure infusion pump assembly 100' and remote control assembly 300 to be in "airplane" mode, in which each of infusion pump assembly 100' and remote control assembly 300 suspends any and all data transmissions. While in "airplane" mode, infusion pump assembly 100' and remote control assembly 300 may or may not continue to receive data.

[0339] 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 aborting the administration of a bolus dose of the infusible fluid.

[0340] Checking Battery Life: Reusable housing assembly 102 may include a rechargeable battery assembly capable of powering infusion pump assembly 100, 100' for approximately three days (when fully charged). This rechargeable battery assembly may have a predetermined useful lifespan, such as a predetermined number of usable hours, or a predetermined number of years, or other predetermined useful length. However, this predetermined lifespan may depend on a number of factors, including, but not limited to, one or more of the following: climate, daily usage, and number of recharges. When 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 as long as switch assembly 318 is depressed within a defined period of time (e.g., greater than two seconds). If the rechargeable battery assembly is determined to be charged above a desired threshold, infusion pump assembly 100, 100' may provide a "battery good" tone. Alternatively, if the rechargeable battery assembly is determined to be charged below a desired threshold, infusion pump assembly 100, 100' may provide a "battery bad" tone. Infusion pump assembly 100 , 100 ′ may include components and / or circuitry to determine whether reusable housing assembly 102 is disconnected from disposable housing assembly 114 .

[0341] Pairing: As described above and in one exemplary embodiment of the above-described infusion pump assembly, infusion pump assembly 100' may be configured to communicate with remote control assembly 300. To enable communication between infusion pump assembly 100' and remote control assembly 300, a pairing process may be performed. During this 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 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').

[0342] According to one embodiment, to complete this pairing process, the user may simultaneously hold down one or more switch assemblies on remote control assembly 300 and infusion pump assembly 100'. For example, the user may simultaneously hold down switch assembly 310 included within remote control assembly 300 and switch assembly 318 included within infusion pump assembly 100' for a defined period of time, e.g., five seconds. Once this defined period of time has elapsed, one or more of remote control assembly 300 and infusion pump assembly 100' may generate an audible signal indicating that the pairing process described above has been completed.

[0343] According to another embodiment, before performing the pairing process, the user may separate reusable housing assembly 102 from disposable housing assembly 114. Requiring this initial step provides further assurance that the infusion pump assembly being worn by the user cannot be surreptitiously paired with the remote control assembly.

[0344] Once separated, 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 the menu system described above in conjunction with, for example, switch assembly 310. The user may be prompted on display assembly 302 of remote control assembly 300 to press and hold switch assembly 318 on infusion pump assembly 100'. Additionally, remote control assembly 304 may transition to a low-power mode, e.g., to avoid attempting to pair with a distant infusion pump assembly. The user may then press and hold switch assembly 318 on infusion pump assembly 100', causing infusion pump assembly 100' to enter a receive mode and await a pairing command from remote control assembly 300.

[0345] Remote control assembly 300 may then transmit a pairing request to infusion pump assembly 100', which may acknowledge receipt of the pairing request. 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 the pump pairing signal (i.e., enter active pairing mode). Remote control assembly 300 may perform a security check on the acknowledgement of receipt received from infusion pump assembly 100'.

[0346] The confirmation received from infusion pump assembly 100' may define the serial number of infusion pump assembly 100', and remote control assembly 300 may display this serial number on display assembly 302 of remote control assembly 300. The user may be asked whether they wish to pair with the discovered 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'.

[0347] The user may then depress and hold switch assembly 318 on infusion pump assembly 100 ′ and depress and hold switch assembly 310 on, for example, remote control assembly 300 .

[0348] Remote control assembly 300 may confirm that remote switch assembly 310 is held (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 confirm 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 pairing configuration file is rewritten to reflect the newly paired remote control assembly 300, a pump pairing complete signal is activated, and the pairing process is complete.

[0349] Additionally, infusion pump assembly 100' may confirm that switch assembly 318 is held (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 the integrity of the confirmation. If the integrity of the received confirmation is not verified, the pairing process may be aborted. If the integrity of the received confirmation is verified, the pairing list file within remote control assembly 300 may be modified to add infusion pump assembly 100'. Typically, remote control assembly 300 is capable of pairing with multiple infusion pump assemblies, while infusion pump assembly 100' is only capable of pairing with a single remote control assembly. A pairing completion signal may be activated and the pairing process may be completed.

[0350] When the pairing process is complete, one or more of remote control assembly 300 and infusion pump assembly 100' may generate an audible signal indicating that the pairing process has been successfully completed.

[0351] Aborting a Bolus Dose: If the user wishes to cancel a bolus dose, e.g., of insulin, being administered by infusion pump assembly 100', the user may depress switch assembly 318 (e.g., as shown) within a defined period exceeding, e.g., five seconds. Figure 1 and Figure 2 ). Once this defined period is reached, infusion pump assembly 100' may provide an audible signal indicating that the cancellation process described above is complete.

[0352] Although switch assembly 318 is shown as being positioned on infusion pump assembly 100, 100', this is for illustrative purposes only and is not intended to be limiting of the present disclosure, as other configurations are possible. For example, switch assembly 318 may be positioned near the periphery of infusion pump assembly 100, 100'.

[0353] In addition, refer to Figure 13-15 , an alternative embodiment of an infusion pump assembly 400 is shown. As with pump assemblies 100, 100', infusion pump assembly 400 may include a reusable housing assembly 402 and a disposable housing assembly 404.

[0354] In a manner similar to reusable housing assembly 102, reusable housing assembly 402 may include a mechanical control assembly (which includes 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 and effectuate delivery of an infusible fluid to a user. The valve assembly may be configured to control the flow of the infusible fluid through the fluid path, while the pump assembly may be configured to pump the infusible fluid from the fluid path to the user.

[0355] In a manner similar to disposable housing assembly 114, disposable housing assembly 404 may be configured for a single use or for a specified period of time, such as three days or any other amount of time. Disposable housing assembly 404 may be configured such that any components of infusion pump assembly 400 that come into contact with the infusible fluid are disposed on and / or within disposable housing assembly 404.

[0356] In this particular embodiment of an infusion pump assembly, infusion pump assembly 400 may include a switch assembly 406 positioned near 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 make it easier for a user to use. Switch assembly 406 may be covered with a waterproof membrane configured to prevent water from penetrating into infusion pump assembly 400. Reusable housing assembly 402 may include a main body portion 408 (housing the mechanical and electrical control assemblies described above) and a locking ring assembly 410 that may be configured to rotate about main body portion 408 (in the direction of arrow 412).

[0357] In a manner similar to reusable housing assembly 102 and disposable housing assembly 114, reusable housing assembly 402 may be configured to releasably engage with disposable housing assembly 404. This releasable engagement may be achieved, for example, by a screw-on, twist-lock, or press-fit configuration. In embodiments utilizing a twist-lock configuration, a user of infusion pump assembly 400 may first appropriately 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.

[0358] By using locking ring assembly 410, reusable housing assembly 402 can be properly positioned relative to disposable housing assembly 404 and then releasably engaged by rotating locking ring assembly 410, thereby eliminating the need to rotate reusable housing assembly 402 relative to disposable housing assembly 404. Thus, reusable housing assembly 402 can be properly aligned with disposable housing assembly 404 prior to engagement, and this alignment is not disturbed during the engagement process. Locking ring assembly 410 may include a latch mechanism (not shown) that prevents rotation of locking ring assembly 410 until reusable housing assembly 402 and disposable housing assembly 404 are properly positioned relative to each other.

[0359] In addition, refer to Figure 16-18 , an alternative embodiment of an infusion pump assembly 500 is shown. As with pump assemblies 100, 100', infusion pump assembly 500 may include a reusable housing assembly 502 and a disposable housing assembly 504.

[0360] In a manner similar to reusable housing assembly 402, reusable housing assembly 502 may include a mechanical control assembly (which includes 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 and effectuate delivery of an infusible fluid to a user. The valve assembly may be configured to control the flow of the infusible fluid through the fluid path, while the pump assembly may be configured to pump the infusible fluid from the fluid path to the user.

[0361] In a manner similar to disposable housing assembly 404, disposable housing assembly 504 may be configured for a single use or for a specified period of time, such as three days or any other amount of time. Disposable housing assembly 504 may be configured such that any components of infusion pump assembly 500 that come into contact with the infusible fluid are disposed on and / or within disposable housing assembly 504.

[0362] In this particular embodiment of an infusion pump assembly, infusion pump assembly 500 may include a switch assembly 506 positioned near 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 make it easier for a user to use. Switch assembly 506 may be covered with a waterproof membrane and / or an O-ring, or other sealing mechanism may be included on stem 507 of switch assembly 506, the sealing mechanism being configured to prevent water from penetrating into infusion pump assembly 500. However, in some embodiments, switch assembly 506 may include an overmolded rubber button, thereby providing a waterproof seal without the use of a waterproof membrane or O-ring. However, in 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 portion 508 (housing the mechanical and electrical control components described above) and a locking ring assembly 510, which may be configured to rotate about main body portion 508 (in the direction of arrow 512).

[0363] In a manner similar to reusable housing assembly 402 and disposable housing assembly 404, reusable housing assembly 502 may be configured to releasably engage with disposable housing assembly 504. This releasable engagement may be achieved, for example, by a screw-on, twist-lock, or press-fit configuration. In embodiments utilizing a twist-lock configuration, a user of infusion pump assembly 500 may first appropriately 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.

[0364] Because locking ring assembly 510 included within infusion pump assembly 500 is taller than locking ring assembly 410 (i.e., as indicated by arrow 514), locking ring assembly 510 may include channel 516 through which button 506 may pass. Thus, when reusable housing assembly 502 is assembled, locking ring assembly 510 may be installed onto main body portion 508 (in the direction of arrow 518). Once locking ring assembly 510 is installed onto main body portion 508, one or more locking protrusions (not shown) may prevent locking ring assembly 510 from being removed from main body portion 508. The portion of switch assembly 506 protruding through channel 516 may then be pressed into main body portion 508 (in the direction of arrow 520), thereby completing the installation of switch assembly 506.

[0365] Although button 506 is shown at various locations on infusion pump assembly 500 , in other embodiments, button 506 may be located at any desired location on infusion pump assembly 500 .

[0366] By using locking ring assembly 510, reusable housing assembly 502 can be properly positioned relative to disposable housing assembly 504 and then releasably engaged by rotating locking ring assembly 510, thereby eliminating the need to rotate reusable housing assembly 502 relative to disposable housing assembly 504. Thus, reusable housing assembly 502 can be properly aligned with disposable housing assembly 504 prior to engagement, and this alignment is not disturbed during the engagement process. Locking ring assembly 510 can include a latch mechanism (not shown) that prevents rotation of locking ring assembly 510 until reusable housing assembly 502 and disposable housing assembly 504 are properly positioned relative to each other. Channel 516 can be elongated to allow movement of locking ring 510 about switch assembly 506.

[0367] In addition, refer to Figures 19A-19B and Figure 20-21 , shows different views of infusion pump assembly 500, which is shown to include reusable housing assembly 502, switch assembly 506, and main body 508. As described above, main body 508 may include a number of components, examples of which may 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. To improve clarity, printed circuit board 600 has been removed from the Figure 19B The printed circuit board 600 is removed to enable viewing of the various components positioned beneath the printed circuit board 600 .

[0368] Various electrical components that can be electrically coupled to the printed circuit board 600 can use spring-biased terminals that allow for electrical coupling without soldering the connections. For example, the vibration motor assembly 602 can use a pair of spring-biased terminals (one positive terminal and one negative terminal) that are configured to press against corresponding conductive pads on the printed circuit board 600 when the vibration motor assembly 602 is positioned on the printed circuit board 600. However, in this exemplary embodiment, the vibration motor assembly 602 is soldered directly to the printed circuit board.

[0369] As described 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 employ acoustic volume sensing, which is the subject of U.S. Patent Nos. 5,575,310 and 5,755,683, and U.S. Patent Application Publication Nos. US2007 / 0228071A1, US2007 / 0219496A1, US2007 / 0219480A1, and US2007 / 0219597A1, all assigned to DEKA Products Limited Partnership, the entire disclosures of all of which are incorporated herein by reference.

[0370] Vibration motor assembly 602 may be configured to provide a vibration-based signal to the user of infusion pump assembly 500. For example, if the voltage of battery 606 (which powers infusion pump assembly 500) falls below a minimum acceptable voltage, vibration motor assembly 602 may cause infusion pump assembly 500 to vibrate to provide a vibration-based signal to the user of infusion pump assembly 500. Shape memory actuator anchor 604 may provide a mounting point for the aforementioned shape memory actuator (e.g., shape memory actuator 112). As described above, shape memory actuator 112 may, for example, be a conductive shape memory alloy wire that changes shape with temperature. The temperature of shape memory actuator 112 may be altered using a heater or, more conveniently, by applying electrical energy. Thus, one end of shape memory actuator 112 may be rigidly fixed (i.e., anchored) to shape memory actuator anchor 604, while the other end of shape memory actuator 112 may be applied to, for example, a valve assembly and / or pump actuator. Thus, by applying electrical energy to shape memory actuator 112, the length of shape memory actuator 112 may be controlled, and thus the valve assembly and / or pump actuator to which shape memory actuator 112 is attached may be operated.

[0371] Antenna assembly 608 may be configured to allow, for example, wireless communication between infusion pump assembly 500 and remote control assembly 300 ( FIG. 11 ). As described above, remote control assembly 300 may allow a user to program infusion pump assembly 500 and, for example, configure bolus infusion events. As described above, infusion pump assembly 500 may include one or more valve assemblies configured to control the flow of an infusible fluid through a fluid path (within infusion pump assembly 500), while pump assembly 106 may be configured to pump the infusible fluid from the fluid path to the user. In this particular embodiment of infusion pump assembly 500, infusion pump assembly 500 is shown as including three valve assemblies, namely, measurement valve assembly 610, volume sensor valve assembly 612, and reservoir valve assembly 614.

[0372] As mentioned above and also with reference to Figure 21, the infusible fluid may be stored in reservoir 118. To effectuate delivery of the infusible fluid to the user, processing logic (not shown) included within infusion pump assembly 500 may actuate shape memory actuator 112, which may be anchored at one end using shape memory actuator anchor 604. Figure 22A , shape memory actuator 112 may result in activation of pump assembly 106 and reservoir valve assembly 614. Reservoir valve assembly 614 may include reservoir valve actuator 614A and reservoir valve 614B, and activation of reservoir valve assembly 614 may result in downward displacement of reservoir valve actuator 614A and closing of reservoir valve 614B, resulting in effective isolation of reservoir 118. Furthermore, pump assembly 106 may include pump plunger 106A and pump chamber 106B, and activation of pump assembly 106 may result in downward displacement of pump plunger 106A into pump chamber 106B and transfer of infusible fluid (in the direction of arrow 616).

[0373] Volume sensor valve assembly 612 may include volume sensor valve actuator 612A and volume sensor valve 612B. Figure 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 pressure of the displaced infusible fluid is sufficient to overcome the mechanical sealing force of volume sensor valve assembly 612, a displacement of the infusible fluid occurs in the direction of arrow 618. This may result in filling of volume sensor chamber 620 included within volume sensor assembly 148. Using speaker assembly 622, port assembly 624, reference microphone 626, spring diaphragm 628, and variable volume microphone 630, volume sensor assembly 148 may determine the volume of the infusible fluid contained within volume sensor chamber 620.

[0374] In addition, refer to Figure 22C Once the volume of the infusible fluid contained within volume sensor chamber 620 is calculated, shape memory actuator 632 may be energized, resulting in activation of measurement valve assembly 610, which may include measurement valve actuator 610A and measurement valve 610B. Once activated, and due to the mechanical energy applied to the infusible fluid within volume sensor chamber 620 by spring diaphragm 628, 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.

[0375] In addition, refer to Figure 23, shows an exploded view of infusion pump assembly 500. Shape memory actuator 632 may be anchored (at 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 activate 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 activate pump plunger 106A. Measurement valve 610B, volume sensor valve 612B, and / or reservoir valve 614B may be self-contained valves configured to be installed during assembly of infusion pump assembly 500 by pressing the valves upward into the lower surface of main body 508.

[0376] In addition, refer to Figure 24 and Figures 25A-25D , shows 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 rod assembly 650.

[0377] In addition, refer to Figures 26A-26B as well as Figures 27A-27B , shows a more detailed view of the measurement valve assembly 610. As described above, the valve assembly 638 can activate the measurement valve assembly 610.

[0378] In addition, refer to Figures 28A-28DInfusion pump assembly 500 may include measurement valve assembly 610. As described above, valve assembly 638 is activatable via shape memory actuator 632 and actuator assembly 640. Therefore, to infuse the amount 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, during which measurement valve latch 656 prevents valve assembly 638 from returning to its inactivated position. Shape memory actuator 652 may be anchored at a first end using electrical contact 654. The other end of shape memory actuator 652 may be connected to valve latch 656. When activated, shape memory actuator 652 may pull valve latch 656 forward and release valve assembly 638. In this manner, measurement valve assembly 610 may be activated via shape memory actuator 632. Once measurement valve assembly 610 has been activated, valve latch 656 can automatically latch valve assembly 638 in the activated position. Actuating shape memory actuator 652 can pull valve latch 656 forward and release valve assembly 638. Assuming shape memory actuator 632 is no longer activated, measurement valve assembly 610 can move to the inactive state once valve latch 656 has released valve assembly 638. Thus, through the use of measurement valve assembly 610, shape memory actuator 632 need not be activated during the entire time it takes to infuse the amount of infusible fluid stored in volume sensor chamber 620.

[0379] As described 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., via a fluid pathway, and may be in fluid communication with cannula assembly 138, e.g., directly or via cannula interface 142.

[0380] In addition, refer to Figure 29, shows an alternative embodiment of an infusion pump assembly 700 configured to store a portion of tubing assembly 140. Specifically, infusion pump assembly 700 may include a peripheral tubing storage assembly 702 configured to allow a user to wrap a portion of tubing assembly 140 around the periphery of infusion pump assembly 700 (in a manner similar to a yo-yo). Peripheral tubing storage assembly 702 may be positioned around the periphery of infusion pump assembly 700. Peripheral tubing storage assembly 702 may be configured as an open slot into which a portion of tubing assembly 140 may be wrapped. Alternatively, peripheral tubing storage assembly 702 may include one or more dividers 704, 706 that form a plurality of narrower slots, each sized to create an interference fit between the walls of the narrower slots and the outer surface of the portion of tubing 140. When peripheral tubing storage assembly 705 includes multiple dividers 704, 706, the resulting narrower slots may be wrapped in a spiral pattern around the periphery of infusion pump assembly 700 (in a manner similar to the threads of a screw).

[0381] In addition, refer to Figure 30-31 , shows an alternative embodiment of an infusion pump assembly 750 configured to store a portion of tubing assembly 140. Specifically, infusion pump assembly 750 may include a peripheral tubing storage assembly 752 configured to allow a user to wrap a portion of tubing assembly 140 around the periphery of infusion pump assembly 750 (again, in a manner similar to a yo-yo). Peripheral tubing storage assembly 752 may be positioned around the periphery of infusion pump assembly 750. Peripheral tubing storage assembly 752 may be configured as an open slot into which a portion of tubing assembly 140 is wound. Alternatively, peripheral tubing storage assembly 752 may include one or more dividers 754, 756 that form a plurality of narrower slots, each sized to create an interference fit between the walls of the narrower slots and the outer surface of the portion of tubing 140. When peripheral tubing storage assembly 752 includes multiple dividers 754, 756, the resulting narrower slots may be wrapped in a spiral pattern around the periphery of infusion pump assembly 750 (again, in a manner similar to the threads of a screw).

[0382] Infusion pump assembly 750 may include tubing retainer assembly 758. Tubing retainer assembly 758 may be configured to releasably secure tubing assembly 140 to prevent tubing assembly 140 from unraveling 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 squeezed. Thus, a user may wrap tubing assembly 140 around the periphery of infusion pump assembly 750, with each turn of tubing assembly 140 being secured within peripheral tubing storage assembly 752 via tubing retainer assembly 758. If the user wishes to lengthen the unsecured portion of tubing assembly 140, the user may release a turn of tubing assembly 140 from tubing retainer assembly 758. Conversely, if the user wishes to shorten the unsecured portion of the tube assembly 140 , the user may secure another turn of the tube assembly 140 within the tube retainer assembly 758 .

[0383] In addition, refer to Figures 32-33 , an exemplary embodiment of infusion pump assembly 800 is shown. As with infusion pump assemblies 100 , 100 ′, 400 , and 500 , infusion pump assembly 800 may include reusable housing assembly 802 and disposable housing assembly 804 .

[0384] In addition, refer to Figures 34A-34B In a manner similar to infusion pump assembly 100, reusable housing assembly 802 may be configured to releasably engage with disposable housing assembly 804. This releasable engagement may be achieved, for example, via a screw-on, twist-lock, or press-fit configuration. Infusion pump assembly 800 may include locking ring assembly 806. For example, reusable housing assembly 802 may be appropriately positioned relative to disposable housing assembly, and locking ring assembly 806 may be rotated to releasably engage reusable housing assembly 802 and disposable housing assembly 804.

[0385] Locking ring assembly 806 may include a lug 808 that may facilitate rotation of locking ring assembly 806. Additionally, the position of lug 808, for example relative to protrusion 810 of disposable housing assembly 804, may provide verification that reusable housing assembly 802 is fully engaged with disposable housing assembly 804. For example, Figure 34A As shown in FIG, when reusable housing assembly 802 is properly aligned with disposable housing assembly 804, lug 808 can be aligned in a first position relative to protrusion 810. After achieving a fully engaged state by rotating locking ring assembly 806, lug 808 can be aligned in a second position relative to protrusion 810, as shown in FIG. Figure 34B As shown in .

[0386] In addition, refer to Figures 35A-35C and Figure 36-38AIn a similar manner to reusable housing assembly 102, reusable housing assembly 802 may include mechanical control assembly 812 (e.g., which may include Figure 36 , which includes one or more valves and one or more pumps for pumping and controlling the flow of the infusible fluid. Furthermore, reusable housing assembly 802 may include an electrical control assembly 816 that may be configured to provide control signals to mechanical control assembly 812 to effectuate delivery of the infusible fluid to the user. Valve assembly 814 may be configured to control the flow of the infusible fluid through the fluid path, while the pump assembly may be configured to pump the infusible fluid from the fluid path to the user.

[0387] Mechanical control assembly 812 and electrical control assembly 816 may be housed within a housing defined by substrate 818 and body 820. In some embodiments, one or more of substrate 818 and body 820 may provide electromagnetic shielding. In this embodiment, the electromagnetic shielding may prevent and / or reduce electromagnetic interference received by electrical control assembly 816 and / or electromagnetic interference generated by electrical control assembly 816. Additionally or alternatively, an EMI shield 822 may be included, such as Figure 36 and Figure 37 EMI shield 822 may provide shielding from generated and / or received electromagnetic interference.

[0388] Reusable housing assembly 802 may include a switch assembly that may be configured to receive user commands (e.g., for bolus delivery, pairing with a remote control assembly, etc.). The switch assembly may include a button 824 that may be disposed in an opening 826 of body 820. For example, Figure 35B As shown in , the locking ring assembly 806 may include a radial slot 828 that may be configured to allow the locking ring assembly 806 to rotate relative to the body 820 while still providing convenient access to the button 824.

[0389] In addition, refer to Figures 39A-39CElectrical 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 that has been dispensed and, based on the user's desired dose, determine whether sufficient infusible fluid has been dispensed. If insufficient infusible fluid has been dispensed, electrical control assembly 816 may determine that more infusible fluid should be pumped. Electrical control assembly 816 may provide appropriate signals to mechanical control assembly 812 to pump any additional required dose, or may provide appropriate signals to mechanical control assembly 812 to dispense the additional dose with the next dispensing. Alternatively, if too much infusible fluid has been dispensed, electrical control assembly 816 may provide appropriate signals to mechanical control assembly 812 to dispense less infusible fluid with the next dispensing. Electrical control assembly 816 may include one or more microprocessors. In an exemplary embodiment, electrical control assembly 816 may include three microprocessors. One processor (for example, which may include, but is not limited to, a CC2510 microcontroller / RF transceiver available from Chipcon AS of Oslo, Norway) may be dedicated to radio communications, such as for communicating with a remote control assembly. Two additional microprocessors (for example, which may include, but are not limited to, an MSP430 microcontroller available from Texas Instruments Inc. of Dallas, Texas) may be dedicated to issuing and executing commands (for example, dispensing a dose of an infusible fluid, processing feedback signals from a volume measurement device, etc.).

[0390] like Figure 35C As shown in FIG, substrate 818 may provide access to electrical contacts 834, for example, electrical contacts 834 may be electrically coupled to electrical control assembly 816 for recharging 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 by cooperating features (e.g., protrusions) of disposable housing assembly 804. Additionally, as shown Figures 40A-40C , 41A-41B, and 42A-42C, base plate 818 may include various features for mounting valve assembly 814 and electrical control assembly 816 and providing access to disposable housing assembly 804 through valve assembly 814.

[0391] Locking ring assembly 806 may include gripping inserts 840, 842, for example, which may include an elastomeric or textured material that facilitates gripping and twisting of locking ring assembly 806, for example, for engaging and disengaging reusable housing assembly 802 and disposable housing assembly 804. Additionally, locking ring assembly 806 may include a sensing component (e.g., a magnet 844) that interacts with a component of reusable housing assembly 802 (e.g., a Hall effect sensor) to, for example, provide an indication of the characteristics of a mating component (e.g., which in some embodiments may include, but is not limited to, one or more of disposable housing assembly 804, a charging station, or a filling station) and / or an indication of whether reusable housing assembly 802 is properly engaged with the mating component. In this exemplary embodiment, a Hall effect sensor (not shown) may be located on the pump printed circuit board. The Hall effect sensor can detect when the locking ring is rotated to the closed position. Thus, the Hall effect sensor, along with magnet 844, can provide a system for determining whether the locking ring has been rotated to the closed position.

[0392] The sensing component (magnet 844), along with a component of the reusable housing assembly, in this exemplary embodiment, a Hall effect sensor, can be used to determine whether the reusable housing assembly is properly attached to the desired component or device. Without being attached to a component, namely, the disposable housing assembly 804, the dust cover, or the charger, the locking ring assembly 806 cannot rotate. Thus, the sensing component, along with the components of the reusable housing assembly, can be used to provide a number of 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 it is attached to a disposable assembly, dust cover, or charger, the system can notify, warn, or alert the user that reusable portions, such as valves and pumping components, may be susceptible to contamination or damage, which could jeopardize the integrity of the reusable assembly. Thus, the system can provide an integrity alert to warn the user of potential reusable integrity threats. Furthermore, if the system senses that the reusable assembly is attached to the dust cover, the system can power off or reduce power to conserve electricity. This can provide a more efficient use of power when the reusable assembly is not connected to a component it needs to interact with.

[0393] Reusable housing assembly 802 can be attached to a number of different components, including but not limited to a disposable housing assembly, a dust cover, or a battery charger / battery charging station. In each case, the Hall effect sensor can detect that the locking ring is in the closed position, and thus can detect that the reusable housing assembly 802 is releasably engaged to the disposable housing assembly, the dust cover, or the battery charger / battery charging station (or another component). The infusion pump system can determine the component to which it is attached by using the AVS system described in more detail below or by electronic contacts. Referring now also to Figures 38B-38D, shows one embodiment of a dust cover (e.g., dust cover 839). In this exemplary embodiment, dust cover 839 may include features 841, 843, 845, and 847 that allow the locking ring of reusable housing assembly 802 to releasably engage with dust cover 839. Furthermore, dust cover 839 may further include a recessed area 849 for accommodating valves and pumping features of reusable housing assembly 804. For example, with respect to a dust cover, the AVS system may determine that a dust cover, rather than a disposable housing assembly, is attached to the reusable housing assembly. The AVS system may use a lookup table or other comparative data and compare the measured data with the characteristic dust cover or empty disposable housing assembly data to distinguish. In this exemplary embodiment, with respect to a battery charger, the battery charger may include electrical contacts. When the reusable housing assembly is attached to the battery charger, the infusion pump assembly electronics may sense that contact has been made and thereby indicate that the reusable housing assembly is attached to the battery charger.

[0394] In addition, refer to Figures 43A-45B and Figures 44A-44C , shows an embodiment of a valve assembly 814, which may include one or more valves and one or more pumps. As with 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. Similar to the previously described, reservoir valve 850 and plunger pump 852 may be actuated by shape memory actuator 858, which may be anchored (at a first end) to shape memory actuator anchor 860. Additionally, measurement valve 856 may be actuated via valve actuator 862 by shape memory actuator 864, which may be anchored (at a first end) to shape memory actuator anchor 866. In a similar manner as described above, the measurement valve may be maintained in an open position via measurement valve latch assembly 868. The measuring valve 856 can be released via actuation of a shape memory actuator 870, which can be anchored (at a first end) by a shape memory actuator anchor 872. In some embodiments, the shape memory actuator anchor 860 can be attached to the reusable housing assembly. This process is used during manufacturing to ensure that the shape memory length actuator 858 is installed and maintains the desired length and tension / strain.

[0395] In addition, refer to Figures 45A-45B and Figures 46A-46E , shape memory actuator 858 (e.g., which may include one or more shape memory wires) may actuate plunger pump 852 via actuator assembly 874. Actuator assembly 874 may include a bias spring 876 and a rod assembly 878. Actuator assembly 874 may actuate plunger pump 852 and metering valve 850.

[0396] In addition, refer to Figures 47A-47B, the measurement valve 856 can be actuated by the shape memory actuator 864 via the valve actuator 862 and the rod assembly 878. Once actuated, the measurement valve latch assembly 868 can maintain the measurement valve 856 in the open position. The measurement valve latch assembly 868 is actuated by the shape memory actuator 870 to release the measurement valve 856, allowing the measurement valve 856 to return to the closed position.

[0397] Disposable housing assembly 804 may be configured for a single use or for a specified period of time, such as three days or any other amount of time. Disposable housing assembly 804 may be configured such that any components of infusion pump assembly 800 that come into contact with the infusible fluid may be disposed on and / or within disposable housing assembly 804. In this way, the risk of contamination of the infusible fluid may be reduced.

[0398] In addition, refer to Figure 48 and Figures 49A-49C , the disposable housing assembly 804 may include a base 900, a membrane assembly 902, and a top 904. The base 900 may include a recess 906 that, together with the membrane assembly 902, defines a reservoir 908 for receiving an infusible fluid (not shown), such as insulin. Figures 50A-50C , the recess 906 can be at least partially formed by and integrally formed with the base 900. The membrane assembly 902 can be sealingly engaged with the base 900, for example, by being compressively sandwiched between the base 900 and the top 904. The top 904 can be attached to the base 900 by conventional means such as gluing, heat sealing, ultrasonic welding, and press-fitting. Additionally or alternatively, the membrane assembly 902 can be attached to the base 900, for example, via gluing, ultrasonic welding, heat sealing, etc., to provide a seal between the membrane assembly 902 and the base 900.

[0399] Still refer to Figure 48 and Figure 50A In the exemplary embodiment, recess 906 includes a raised portion 901 that includes an area 903 surrounding a fluid opening 905 that leads to a fluid line. In the exemplary embodiment, raised portion 901 extends around the perimeter of recess 906. However, in other embodiments, raised portion 901 may not extend the entire perimeter, but may partially surround the perimeter. As shown in this exemplary embodiment, area 903 surrounding fluid opening 905 may be shaped to include an angled portion. In some embodiments, area 903 includes a 45-degree angle, although in other embodiments, the angle may be larger or smaller. In some embodiments, the pump may not be able to generate a sufficient vacuum to collapse the reservoir, thereby expelling the entire volume of fluid that may be stored in the reservoir. Raised portion 901 can be used to minimize wasted fluid.

[0400] In this exemplary embodiment, the fluid openings 905 may include three openings, however, in other embodiments, more or fewer openings may be included, surrounded by the raised region 903. In this exemplary embodiment, the fluid openings 905 may be narrow in the center, thereby creating surface tension that prevents air from entering the openings. In this exemplary embodiment, this region may be designed to encourage any air present in the reservoir to be drawn over one of the fluid openings 905 rather than through the fluid opening 905 and into the fluid circuit. Additionally, because there may be more than one fluid opening 905, if an air bubble becomes trapped above one opening, the air will not prevent fluid from flowing through the other two openings.

[0401] In addition, refer to Figures 51A-51C Disposable housing assembly 804 may also include a fluid pathway cover 910. Fluid pathway cover 910 may be housed in a cavity 912 formed on / within base 900. In some embodiments, fluid pathway cover 910 may include at least a portion of one or more channels (e.g., channel 914). The channels included in fluid pathway cover 910 may be fluidically coupled to one or more volcano valve devices (e.g., volcano valve 916) included on base 900. Volcano valve 916 may include a protrusion having an opening extending therethrough. Additionally, fluid pathway cover 910 and base 900 may each define a portion of a recess (e.g., recesses 918 and 920 included in base 900 and fluid pathway cover 910, respectively) for fluidically coupling to an infusion set (e.g., including cannula 922). Cannula 922 may be coupled to disposable housing assembly 804 by conventional means (e.g., gluing, heat sealing, press-fitting, etc.). The fluid pathway defined by the fluid pathway cover 910 and the volcano valve (e.g., volcano valve 916) of the base 900 can define a fluid pathway between the reservoir 908 and the cannula 922 for delivering an infusible fluid to a user via the infusion set. However, in some embodiments, the fluid pathway cover 910 can include at least a portion of the fluid pathway, while in some embodiments, the fluid pathway cover 910 can exclude at least a portion of the fluid pathway. In this exemplary embodiment, the fluid pathway cover 910 can be laser welded to the base 900. However, in other embodiments, the fluid pathway cover 910 can also be connected to the base 900 by conventional means (e.g., gluing, heat sealing, ultrasonic welding, press-fitting, etc.) to achieve a substantially fluid-tight seal between the fluid pathway cover 910 and the base 900.

[0402] In addition, refer to Figures 54A-54CDisposable housing assembly 804 may further include a valve membrane cover 924. Valve membrane cover 924 may be at least partially disposed over a volcano valve (e.g., volcano valve 916) and pumping recess 926 included on / within base 900. Valve membrane cover 924 may include a flexible material, for example, which may be selectively engaged against the volcano valve by reservoir valve 850, volume sensor valve 854, and measurement valve 856 of reusable housing assembly 802, for example, to control the flow of an infusible fluid. Additionally, valve membrane cover 924 may be elastically deformed into pumping recess 926 by plunger pump 852 to enable pumping of the infusible fluid. Valve membrane cover 924 may be engaged between base 900 and top portion 904 of disposable housing assembly 804 to form a seal 928 between valve membrane cover 924 and base 900. For example, in this exemplary embodiment, valve membrane cover 924 may be overmolded onto base 900. In the exemplary embodiment, valve membrane cover 924 is compressibly sandwiched between base 900 and top 904 to form seal 928. Additionally or alternatively, a valve membrane insert can be connected to one or more of base 900 and top 904, such as by gluing, heat sealing, etc.

[0403] In addition, refer to Figure 53A-C Top portion 904 may include alignment protrusions 930, 932 that may be configured to be at least partially received in openings 836, 838 of 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 protrusions 934, 936, 938, 940 that may be configured to engage with cooperating protrusions 942, 944, 946, 948 of locking ring assembly 806. The one or more radial protrusions (e.g., radial protrusion 940) may include a stop (e.g., alignment protrusion stop 950, which may be used for welding and is a protrusion that fits into a recess for positioning and ultrasonic welding) that may prevent further rotation of locking ring assembly 806 once reusable housing assembly 802 and disposable housing assembly 804 are fully engaged.

[0404] As described above, valve membrane insert 924 can enable pumping and flow of infusible fluid through reservoir valve 850, plunger pump 852, volume sensor valve 854, and measurement valve 856. Thus, top portion 904 can include one or more openings (e.g., openings 952, 954, 956) that can expose at least a portion of valve membrane insert 924 for actuation by reservoir valve 850, plunger pump 852, volume sensor valve 854, and measurement valve 856. Additionally, top portion 904 can include one or more openings 958, 960, 962 that can be configured to allow control of the fill volume during filling of reservoir 908, as will be discussed in greater detail below. Reservoir assembly 902 can include ribs 964, 966, 968 (e.g., as Figure 52A ), the ribs 964, 966, 968 can be at least partially received in respective openings 958, 960, 962. As will be described in more detail below, a force can be applied to one or more of the ribs 964, 966, 968 to at least temporarily reduce the volume of the reservoir 908.

[0405] 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, for example, include an elastomeric member that, when engaged, provides a compressible rubber or plastic layer between reusable housing assembly 802 and disposable housing assembly 804, thereby preventing accidental detachment and penetration of external fluids. For example, sealing assembly 970 may be a watertight seal, thereby enabling a user to wear infusion pump assembly 800 while swimming, bathing, or exercising.

[0406] In a similar manner to, for example, disposable housing assembly 114, in some embodiments, disposable housing assembly 802 may be configured to have a reservoir 908 that can be filled multiple times. However, in some embodiments, disposable housing assembly 114 may be configured such that reservoir 908 is not refillable. Figures 57-64, fill adapter 1000 may be configured to be coupled to disposable housing assembly 804 for refilling reservoir 908 using a syringe (not shown). Fill adapter 1000 may include locking protrusions 1002, 1004, 1006, 1008 that may be configured to engage radial protrusions 934, 936, 938, 940 of disposable housing assembly 804 in a manner generally similar to protrusions 942, 944, 946, 948 of locking ring assembly 806. Thus, fill adapter 1000 may be releasably engaged with disposable housing assembly 804 by aligning fill adapter 1000 with disposable housing assembly 804 and rotating fill adapter 1000 and disposable housing assembly 804 relative to each other to releasably engage locking tabs 1002, 1004, 1006, 1008 with radial tabs 934, 936, 938, 940.

[0407] Fill adapter 1000 may also include a filling aid 1010, which may include a guide channel 1012. For example, guide channel 1012 may be configured to guide a syringe needle (not shown) to the septum of disposable housing assembly 804 to allow the syringe to fill reservoir 908 of disposable housing assembly 804. In some embodiments, guide channel 1012 may include an inclined ramp or another gradually inclined ramp to further guide the syringe to the septum. Fill adapter 1000 may facilitate filling reservoir 908 by, for example, providing a relatively large insertion area at the distal opening of guide channel 1012. Guide channel 1012 may generally taper toward a smaller proximal opening that can 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 skill and aim required to insert a needle through the septum of disposable housing assembly 804 in order to fill reservoir 908 .

[0408] As described above, disposable housing assembly 804 can be configured to facilitate control of the amount of infusible fluid delivered to reservoir 908 during filling. For example, membrane assembly 902 of disposable housing assembly 804 can include ribs 964, 966, 968 that can be depressed and at least partially displaced into reservoir 908, thereby reducing the volume of reservoir 908. Thus, when infusible fluid is delivered to reservoir 908, the volume of fluid that can be accommodated by reservoir 908 can be correspondingly reduced. Ribs 964, 966, 968 can be accessed via openings 958, 960, 962 in top portion 904 of disposable housing assembly 804.

[0409] Fill adapter 1000 may include one or more button assemblies (e.g., button assemblies 1014, 1016, 1018) corresponding 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 cantilevered members that can be depressed. When fill adapter 1000 is releasably engaged with disposable housing assembly 804, one or more of button assemblies 1014, 1016, 1018 may be depressed and, accordingly, may move a respective one of ribs 964, 966, 968 into reservoir 908, resulting in a concomitant reduction in the volume of reservoir 908.

[0410] For example, for illustrative purposes, assume that reservoir 908 has a maximum capacity of 3.00 mL. Furthermore, assume that button assembly 1014 is configured to move rib 964 into disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Furthermore, assume that button assembly 1016 is configured to move rib 966 into disposable housing assembly 804, also resulting in a 0.5 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Furthermore, assume that button assembly 1018 is configured to move trough assembly 968 into disposable housing assembly 804, also resulting in a 0.5 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Thus, if a user wishes to fill reservoir 908 within disposable housing assembly 804 with 2.00 mL of infusible fluid, in some embodiments, the user may first fill the reservoir to a capacity of 3.00 mL and then depress button assemblies 1016 and 1014 (causing ribs 966 to move into disposable housing assembly 804), effectively reducing the 3.00 mL capacity of reservoir 908 within disposable housing assembly 804 to 2.00 mL. In some embodiments, the user may first depress a corresponding number of button assemblies, effectively reducing the capacity of reservoir 908, and then filling reservoir 908. While a specific number of button assemblies is shown to represent this exemplary embodiment, in other embodiments, the number of button assemblies may vary from a minimum of 1 to a desired number. Additionally, while for illustrative purposes and in this exemplary embodiment, each button assembly may displace 0.5 mL, in other embodiments, the volume displaced by each button assembly may vary. Furthermore, in different embodiments, the reservoir may comprise a larger or smaller volume than depicted in this exemplary embodiment.

[0411] According to the above configuration, the fill volume of the reservoir 908 can be controlled, at least in part, using the button assemblies (e.g., button assemblies 1014, 1016, 1018). By not pressing any of the button assemblies, the maximum fill volume of the reservoir 908 can be achieved. Pressing one button assembly (e.g., button assembly 1014) can allow the second-largest fill volume to be achieved. Pressing two button assemblies (e.g., button assemblies 1014, 1016) can allow the third-largest fill volume to be achieved. Pressing all three button assemblies (e.g., button assemblies 1014, 1016, 1018) can allow the minimum fill volume to be achieved.

[0412] Furthermore, in one embodiment, button assemblies 1014, 1016, 1018 can be used, at least in part, to facilitate filling of reservoir 908. For example, once a filling needle (e.g., which can be fluidly coupled to a vial of infusible fluid) has been inserted into reservoir 908, button assemblies 1014, 1016, 1018 can be depressed to pump at least a portion of any air that may be contained within the reservoir into the vial of infusible fluid. Button assemblies 1014, 1016, 1018 can then be released to allow the infusible fluid to flow from the vial into reservoir 908. Once reservoir 908 is filled with the infusible fluid, one or more button assemblies (e.g., one or more of button assemblies 1014, 1016, 1018) can be depressed, thereby forcing at least a portion of the infusible fluid from reservoir 908 (e.g., through the needle used to fill reservoir 908 and back into the vial of infusible fluid). As described above, the volume of infusible fluid contained within reservoir 908 may be controlled, for example, based on how many times the button assembly is depressed (e.g., which may control how much infusible fluid is expressed back into the vial of infusible fluid).

[0413] Special reference Figures 62-64 , the filling aid 1010 can be pivotally coupled to the fill adapter base plate 1020. For example, the filling aid 1010 can include pivot members 1022, 1024 that can be configured to be received in pivot supports 1026, 1028 to enable the filling aid to be pivotally coupled in an open position (e.g., as shown in FIG. Figures 57-61 ) and the closed position (e.g., as Figures 63-64 908). This closed position may be suitable for packaging fill adapter 1000, storing fill adapter 1000, etc. To ensure that filling aid 1010 is properly oriented for filling reservoir 908, fill adapter 1000 may include support member 1030. To properly orient filling aid 1010, a user may pivot filling aid 1010 to a fully open position, in which filling aid 1010 may contact support member 1030.

[0414] According to an alternative embodiment, and also with reference to Figure 65 , fill adapter 1050 can be configured to releasably engage disposable housing assembly 804 via a plurality of locking protrusions (e.g., locking protrusions 1052, 1054). Additionally, fill adapter 1050 can include a plurality of button assemblies (e.g., button assemblies 1056, 1058, 1060) that can interact with ribs 964, 966, 968 of disposable housing assembly 804 to adjust the fill volume of reservoir 908. Fill adapter 1050 can further include a filling aid 1062 having a guide channel 1064 configured to align a syringe needle with the septum of disposable housing 804, e.g., for accessing reservoir 908 for filling reservoir 908 with an infusible fluid. Filling aid 1062 can be connected to base plate 1066, e.g., as an integral component therewith, by gluing, heat sealing, press-fitting, or the like.

[0415] In addition, refer to Figures 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 protrusions 1102, 1104, 1106, 1108 that may be configured to engage radial protrusions 934, 936, 938, 940 of disposable housing assembly in a manner generally similar to protrusions 942, 944, 946, 948 of locking ring assembly 806. Thus, vial fill adapter 1100 may be releasably engaged with disposable housing assembly 804 by aligning vial fill adapter 1100 with disposable housing assembly 804 and rotating vial fill adapter 1100 and disposable housing assembly 804 relative to each other to releasably engage locking tabs 1102, 1104, 1106, 1108 with radial tabs 934, 936, 938, 940.

[0416] As described above, disposable housing assembly 804 can be configured to facilitate control of the amount of infusible fluid delivered to reservoir 908 during filling. For example, membrane assembly 902 of disposable housing assembly 804 can include ribs 964, 966, 968 that can be depressed and at least partially displaced into reservoir 908, thereby reducing the volume of reservoir 908. Thus, when infusible fluid is delivered to reservoir 908, the volume of fluid that can be accommodated by reservoir 908 can be correspondingly reduced. Ribs 964, 966, 968 can be easily accessed via openings 958, 960, 962 in top 904 of disposable housing assembly 804.

[0417] The vial fill adapter 1100 may include ribs 964, 966, 968 (e.g., Figure 52A 968 ). In other words, when vial fill 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 cantilevered members that can be depressed. When vial fill adapter 1100 is releasably engaged with disposable housing assembly 804, one or more of button assemblies 1110, 1112, 1114 may be depressed and, accordingly, may move a corresponding one of ribs 964, 966, 968 into reservoir 908, thereby reducing the volume of reservoir 908.

[0418] For example, for illustrative purposes, assume that reservoir 908 has a maximum capacity of 3.00 mL. Furthermore, assume that button assembly 1110 is configured to move rib 964 into disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Furthermore, assume that button assembly 1112 is configured to move rib 966 into disposable housing assembly 804, also resulting in a 0.5 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Furthermore, assume that button assembly 1114 is configured to move rib 968 into disposable housing assembly 804, also resulting in a 0.50 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Thus, if the user wishes to fill reservoir 908 within disposable housing assembly 804 with 2.00 mL of infusible fluid, the user may depress button assemblies 1112 and 1114 (causing ribs 966 and 968 to move into disposable housing assembly 804), effectively reducing the 3.00 mL capacity of reservoir 908 within disposable housing assembly 804 to 2.0 mL.

[0419] Additionally, vial fill adapter 1100 may include vial filling aid assembly 1116 that may be configured to fluidly couple a vial of infusible fluid to reservoir 908 of disposable housing assembly 804 via a septum. Figure 71The 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 penetrate a septum (not shown) of a vial, and a second needle end 1122 configured to penetrate a septum of disposable housing assembly 804. In this manner, the vial and reservoir 908 may be fluidly coupled, allowing transfer of infusible fluid from the vial to reservoir 908. Double-ended needle assembly 1118 may include a vial engagement portion 1124 adjacent first end 1120. Vial engagement arms 1124, 1126 may be configured to releasably engage, for example, a vial cap to help maintain a fluid connection between double-ended needle assembly 1118 and the vial. Additionally, 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. Vial filling aid body 1132 may include stabilizer arms 1134, 1136, e.g., which may be configured to stabilize a vial during filling of disposable housing assembly 804. In one embodiment, a vial may be engaged with double-ended needle assembly 1118, e.g., such that first end 1120 may penetrate a septum of the vial, while a cap of the vial may be engaged by engagement arms 1124, 1126. Body 1128 may be slidably inserted into opening 1130, such that second end 1122 of double-ended needle assembly 1118 may penetrate a septum of disposable body assembly 804.

[0420] Similar to fill adapter 1000, vial filling aid assembly 1116 can be configured to be pivotally coupled to vial fill adapter base plate 1138. For example, vial filling aid 1116 can include pivot members 1140, 1142 that can be configured to be received within pivot supports 1144, 1146 (e.g., Figure 71 ), thereby enabling the vial filling aid 1116 to be in the open position (e.g., as shown in FIG. Figures 66-70 ) and the closed position (e.g., as Figures 72-74908). This closed position may be suitable for packaging of vial fill adapter 1100, storage of vial fill adapter 1100, etc. To ensure that vial filling aid 1116 is properly oriented for filling reservoir 908, vial fill adapter 1100 may include support member 1148. To properly orient vial filling aid 1116, a user may pivot vial filling aid 1116 to a fully open position, wherein vial filling aid 1116 may contact support member 1148. Additionally, vial fill adapter base plate 1138 may include one or more locking features (e.g., locking tabs 1150, 1152) that may engage vial filling aid 1116 and may retain vial filling aid 1116 in the closed position. Vial fill adapter base plate 1138 may also include features (eg, protrusions 1154 , 1156 ) that may be configured to help retain double ended needle assembly 1118 , for example, by preventing slidable separation of double ended needle assembly 1118 from vial filling aid body 1132 .

[0421] like Figures 72-74 , filling aid assembly 1116 is in the closed position. In this configuration, support member 1148 can additionally serve as a needle guard. When removing filling aid assembly 1116 from disposable housing assembly 804, support member 1148 can be used to enable a user to safely squeeze the tip and rotate filling aid assembly 1116 for removal. Figure 70 As shown in FIG, in the open position, support member 1148 can act as a stop to maintain proper orientation.

[0422] Refer again Figures 57-73 , an exemplary embodiment of the fill adapter includes a gripping device (e.g., Figure 72 1166). Gripping device 1166 can provide a gripping interface for removing the fill adapter from disposable housing assembly 804. Although shown in one configuration in these figures, in other embodiments, this configuration may vary. In other embodiments, a gripping device may not be included.

[0423] According to one embodiment, fill adapter base plate 1020 and vial fill adapter base plate 1138 may be interchangeable components. Thus, a single base plate (e.g., fill adapter base plate 1020 or vial fill adapter base plate 1138) may be used with filling aid 1010 or vial filling aid 1116. Thus, the number of different components required for both fill adapters may be reduced, and a user may be able to select the fill adapter that best suits a given filling scenario.

[0424] Various embodiments of the fill adapter can provide a number of safety benefits, including but not limited to: providing a system for filling the reservoir without manipulating the needle; protecting the reservoir from inadvertent contact with the needle, i.e., a breach of the reservoir's integrity through inadvertent puncture; being designed to be highly ambidextrous; and in some embodiments, providing a system for retaining air in the reservoir.

[0425] As described above, the reusable housing assembly 802 may include a battery 832, which may include a rechargeable battery, for example. Figures 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 that are generally configured to electrically couple 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, and the like. Additionally, top plate 1204 may include alignment tabs 1208, 1210 that may be configured to align with openings 836, 838 (e.g., as shown in FIG. 1 ) in base plate 818 of reusable housing assembly 802. Figure 35C The cooperation of alignment tabs 1208, 1210 and openings 836, 838 ensures that reusable housing assembly 802 is aligned with battery charger 1200 such that electrical contacts 1206 of battery charger 1200 can electrically couple with electrical contacts 834 of reusable housing assembly 802.

[0426] In addition, refer to Figure 77 and Figure 78 , battery charger 1200 may be configured to releasably engage with reusable housing assembly 802. For example, in a manner similar to disposable housing assembly 804, battery charger 1200 may include one or more locking tabs (e.g., Figure 76 ). The locking protrusions (e.g., locking protrusions 1212, 1214) can be engaged by protrusions 942, 944, 946, 948 of the locking ring assembly 806. In this way, the reusable housing assembly 802 can be aligned with the battery charger 1200 (via the alignment protrusions 1208, 1210) while the locking ring 806 is in the first, unlocked position, as shown. Figure 77 The locking ring 806 can be rotated relative to the battery charger 1200 in the direction of arrow 1216 to releasably engage the protrusions 942, 944, 946, 948 of the locking ring 806 with the locking protrusions (e.g., locking protrusions 1212, 1214) of the battery charger 1200. Figure 78 As shown in .

[0427] In one embodiment, battery charger 1200 may include a recessed area 1218, such as in the exemplary embodiment, which may provide clearance for accommodating pumping and valve components of reusable housing assembly 802. Figure 79 and Figure 80 , battery charger 1200 may provide current to electrical contacts 1206 (and thereby to reusable housing assembly 802 via electrical contacts 834) for recharging battery 832 of reusable housing assembly 802. In some embodiments, when a signal indicating a fully engaged reusable housing is not provided, current may not be provided to electrical contacts 1206. According to this embodiment, the risks associated with electrical shorts (e.g., caused by a foreign object contacting electrical contacts 1206) and damage to reusable housing assembly 802 (e.g., caused by improper initial alignment between electrical contacts 1206 and electrical contacts 834) may be reduced. Additionally, battery charger 1200 may not need to draw current when it is not charging reusable housing assembly 802.

[0428] Still refer to Figure 79 and Figure 80 , the battery charger 1200 can include a lower housing portion 1224 and a top plate 1204. A printed circuit board 1222 (eg, which can include electrical contacts 1206) can be disposed within a cavity included between the top plate 1204 and the lower housing portion 1224.

[0429] In addition, refer to Figure 81 -89, showing various embodiments of a battery charger / docking station. Figure 81 and Figure 82Desktop charger 1250 is shown including recess 1252 configured to mate with and recharge a reusable housing assembly (e.g., reusable housing assembly 802). The reusable housing assembly can be placed in recess 1252 and / or can be releasably engaged in recess 1252 in a manner similar to that described above. Additionally, desktop charger 1250 can include recess 1254 configured to mate with a remote control assembly (e.g., remote control assembly 300). Recess 1254 can include a USB plug 1256, for example, which can be configured to connect to the remote control assembly when the remote control assembly is disposed within recess 1254. USB plug 1256 can enable data transfer to and from the remote control assembly and charging of the remote control assembly. Desktop charger 1250 may also include a USB port 1258 (e.g., which may include a mini-USB port) that enables the desktop charger to receive electrical energy (e.g., for charging the reusable housing assembly and / or the remote control assembly). Additionally or alternatively, USB port 1258 may be configured for transferring data to / from the remote control assembly and / or the reusable housing assembly, for example, via connection to a computer (not shown).

[0430] Reference Figures 83A-83B Similar to the 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 for charging and / or transmitting data to / from reusable housing assembly 1262 and / or remote control assembly 1268, respectively.

[0431] Reference Figures 84A-84B , shows another embodiment of a desktop charger. 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 hold 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 for charging and / or transferring data to / from reusable housing assembly 1272 and / or remote control assembly 1274, respectively, as described in the various embodiments above.

[0432] Reference Figures 85A-85D, foldable charger 1280 may include recess 1282 for receiving reusable housing assembly 1284 and remote control assembly 1286. Foldable charger 1280 may include various electrical and data connections configured for charging reusable housing assembly 1284 and / or remote control assembly 1286 and / or transferring data to / from reusable housing assembly 1284 and / or remote control assembly 1286, as described in various embodiments above. Additionally, as Figures 85B-85D As shown in FIG, the foldable charger 1280 may include a pivotable cover 1288. The pivotable cover 1288 may be configured to be in an open position (e.g., Figure 85B ) and the closed position (e.g., as Figure 85D 1282 is pivotable between an open position (shown in FIG. 1284 ), in which reusable housing assembly 1284 and remote control assembly 1286 can be docked in foldable charger 1280, and a closed position in which recess 1282 can be covered by pivotable cover 1288. In the closed position, recess 1282 and any electrical and / or data connections disposed therein can be protected from damage.

[0433] Reference Figure 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, to provide a relatively slim profile. A rear portion of wall charger 1290 may include an electrical plug configured to enable wall charger 1290 to be plugged into an electrical outlet. Thus, when plugged into an electrical outlet, wall charger 1290 may be configured to be wall-mounted. Additionally, when plugged into an electrical outlet, wall charger 1290 may be provided with power for charging reusable housing assembly 1294 and / or remote control assembly 1298.

[0434] Reference Figure 87Wall charger 1300 may include a recess 1302 configured to receive a remote control assembly 1304. Additionally, wall charger 1300 may include a recess (not shown) configured to receive a reusable housing assembly 1306. Wall charger 1300 may be configured to position remote control assembly 1304 and reusable housing assembly 1306 in a back-to-back 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 outlet. Electrical plug 1308 may include a stowable configuration in which electrical plug 1308 can pivot between an extended position (e.g., as shown) and a stowed position. In the extended position, electrical plug 1308 can be oriented for insertion into an electrical outlet. In the stowed position, electrical plug 1308 can be disposed within recess 1310, which may protect electrical plug 1308 from damage and / or from damaging other items.

[0435] Reference Figure 88 , charger 1320 may include recess 1322 configured to receive reusable housing assembly 1324. Charger 1320 may further include a recess (not shown) configured to receive remote control assembly 1326. Charger 1320 may further include lid 1328. Lid 1328 may be configured to pivot between an open position (as shown) and a closed position. When lid 1328 is in the open position, reusable housing assembly 1324 and remote control assembly 1326 are accessible (e.g., allowing a user to remove reusable housing assembly 1324 and / or remote control assembly 1326 from charger 1320, and to install reusable housing assembly 1324 and / or remote control assembly 1326 into charger 1320). When lid 1324 is in the closed position, lid 1328 and charger body 1330 may substantially enclose reusable housing assembly 1324 and / or remote control assembly 1326 and / or recess 1322 and the recess configured to receive remote control assembly 1326, thereby providing protection from damage and / or impairment to reusable housing assembly 1324, remote control assembly 1326, and / or any electrical and / or data connections associated with charger 1320.

[0436] Reference Figures 89A-89BWall charger 1350 may include a recess 1352 configured to receive a remote control assembly 1354. Wall charger 1350 may also include a recess 1356 configured to receive a 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 slim profile. Charger 1350 may further include an electrical plug 1360, for example, which may be configured to be plugged into an electrical outlet. Electrical plug 1360 may include a stowable configuration in which electrical plug 1360 is pivotable between a deployed position (e.g., as shown) and a stowed position. In the deployed position, electrical plug 1360 may be oriented for insertion into an electrical outlet. In the stowed position, electrical plug 1360 may be disposed within recess 1362, which may protect electrical plug 1308 from damage and / or from damaging other items.

[0437] Infusion pump therapy can include both volumetric and time specifications. The amount of fluid dispensed, along with the timing of the dispense, can be two key factors in infusion pump therapy. As discussed in detail below, the infusion pump apparatus and system described herein can provide a method for dispensing fluids and a device, system, and method for measuring the amount of fluid dispensed. However, in situations where the calibration and accuracy of the measuring device are critical, there is the advantage of determining any compromise in the accuracy of the measuring device as quickly as possible. Thus, there is the advantage of off-site verification of volume and pumping.

[0438] As described above, infusion pump assembly 100 may include volume sensor assembly 148 configured to monitor the amount of fluid infused by infusion pump assembly 100. Furthermore, and as described above, infusion pump assembly 100 may be configured such that the volume measurements generated by volume sensor assembly 148 may be used to control the infusible amount infused to the user via a feedback loop.

[0439] In addition, refer to Figures 90A-90C , which shows a diagram and two cross-sectional views of volume sensor assembly 148. Figures 91A-91I , various isometric views and diagrams of volume sensor assembly 148 (which is shown to include upper housing 1400) are provided. Figures 92A-92I , which provides various isometric views and illustrations of volume sensor assembly 148 (with upper housing 1400 removed), exposing speaker assembly 622, reference microphone 626, and printed circuit board assembly 830. Figures 93A-93I , which provides various isometric views and illustrations of volume sensor assembly 148 (with printed circuit board assembly 830 removed), exposing port assembly 624. Figures 94A-94F, which provides various isometric and pictorial cross-sectional views of volume sensor assembly 148 (with printed circuit board assembly 830 removed), exposing port assembly 624. Figure 95 , an exploded view of volume sensor assembly 148 is shown, exposing upper housing 1400 , speaker assembly 622 , reference microphone 626 , seal assembly 1404 , lower housing 1402 , port assembly 624 , spring diaphragm 628 , and retaining ring assembly 1406 .

[0440] The following discussion relates to volume sensor assembly 148 (which is Figure 96 For the discussion that follows, the following terminology may be used:

[0441]

[0442] Derivation of Equations for Volume Sensor Assembly 148: Modeling Acoustic Volume

[0443] The pressure and volume of an ideal adiabatic gas can be related as follows: PV γ =K[EQ#1]

[0444] Here K is a constant defined by the initial state of the system.

[0445] EQ #1 can be written in terms of mean pressure P and volume V and small time-dependent perturbations p(t), v(t) above those pressures and volumes as follows:

[0446] (P+p(t))(V+v(t)) γ =K[EQ#2]

[0447] Differentiating this equation yields:

[0448]

[0449] This simplifies to

[0450]

[0451] If the acoustic pressure level is much lower than the ambient pressure, the equation can be further simplified to:

[0452]

[0453] How good is this assumption? Using the adiabatic relation, it can be shown that:

[0454]

[0455] Therefore, the error in this assumption will be:

[0456]

[0457] A very loud acoustic signal (120 dB) can correspond to a pressure sine wave with an amplitude of approximately 20 Pascals. Assuming atmospheric air (γ = 1.4, P = 101325 Pa), the resulting error is 0.03%. The conversion from dB to Pa is as follows:

[0458]

[0459] Here ref =20·μPa.

[0460] Applying the ideal gas law, P = ρRT, and substituting for pressure yields the following:

[0461]

[0462] EQ#9 can be adjusted based on the speed of sound And written as:

[0463]

[0464] The acoustic impedance for a volume can be defined as follows:

[0465]

[0466] Modeling Acoustic Ports

[0467] An acoustic port can be modeled by assuming that all fluid in the port moves essentially as a rigid cylinder reciprocating in the axial direction. All fluid in the channel is assumed to travel at the same velocity, the channel is assumed to have a constant cross-section, and the "end effects" caused by fluid entering and leaving the channel are neglected.

[0468] If we assume laminar friction of the form Then the friction force acting on the mass of the fluid in the channel can be written as follows:

[0469]

[0470] Then the second-order differential equation for the dynamics of the fluid in the channel can be written as:

[0471]

[0472] Or, based on volume flow rate:

[0473]

[0474] The acoustic impedance of the channel can then be written as follows:

[0475]

[0476] System transfer function

[0477] Using the volumes and port dynamics defined above, volume sensor assembly 148 may be described by the following system of equations: (k = speaker, r = resonator)

[0478]

[0479]

[0480]

[0481]

[0482] If we substitute p0 into , one equation can be eliminated.

[0483]

[0484]

[0485]

[0486] Cross-system transfer function

[0487] The relationship between the loudspeaker volume and the variable volume is called the crossover system transfer function. This transfer function can be derived from the above equation and expressed as follows:

[0488]

[0489] in

[0490]

[0491] In addition, refer to Figure 97 , shows the Bode plot of EQ#23.

[0492] The difficulty with this relationship is that the complex poles depend on both the variable volume V2 and the reference volume V 1. Any change in the mean position of the loudspeakers may result in an error in the estimated volume.

[0493] Cross-port transfer function

[0494] The relationship between the two volumes on each side of the acoustic port is called the cross-port transfer function. This relationship is expressed as follows:

[0495]

[0496] This is Figure 98 The diagram shows.

[0497] This relationship has the advantage that the poles depend only on the variable volume and not on the reference volume. However, it has the disadvantage that the resonant peak is actually due to the inversion of the zero point in the reference volume pressure response. Therefore, the pressure measurement in the reference chamber will have a low amplitude near resonance, potentially increasing the noise in the measurement.

[0498] Cross-speaker transfer function

[0499] In addition, the pressure can be measured on each side of the loudspeaker. This is called the cross-loudspeaker transfer function:

[0500]

[0501] This is Figure 99 The diagram shows.

[0502] In addition to the set of complex poles, this transfer function also has a set of complex zeros.

[0503] Consider the limit of this transfer function: when s→0, and when s→∞,

[0504] Resonant Q factor and peak response

[0505] The quality of a resonance is the ratio of the energy stored to the power lost multiplied by the resonant frequency. For a purely second-order system, the quality factor can be expressed as a function of the damping ratio:

[0506]

[0507] The ratio of the peak response to the low-frequency response can also be written as a function of the damping ratio:

[0508]

[0509] This can occur at the damped natural frequency:

[0510]

[0511] Volume estimation

[0512] Volume estimation using cross-port phasing

[0513] The variable volume (i.e., within volume sensor chamber 620) can also be estimated using the cross-port phase. The transfer function for the pressure ratio across the resonant ports can be expressed as follows:

[0514]

[0515] At the 90° phase point, ω = ω n ;in

[0516] There are many ways to find the resonant frequency of a physical system. A phase-locked loop can be used to find the 90° phase point—this frequency may correspond to the natural frequency of the system. Alternatively, the phase at any two frequencies can be used to calculate the resonant frequency:

[0517] The phase φ at any given frequency will satisfy the following relationship:

[0518]

[0519] in

[0520] Solving for V2, we get:

[0521]

[0522] Therefore, the ratio of the phases at two different frequencies ω1 and ω2 can be used to calculate the natural frequency of the system:

[0523]

[0524] For computational efficiency, it is not necessary to calculate the actual phase. All that is required is the ratio of the real to imaginary part of the response (tanφ).

[0525] Rewriting EQ #23 in terms of variable volume yields:

[0526]

[0527] Volume estimation using swept sine

[0528] The resonant frequency of a system can be estimated using swept-sine system identification. In this method, the system's response to sinusoidal pressure changes is found at many different frequencies. This frequency response data can then be used to estimate the system transfer function using linear regression.

[0529] The transfer function for a system can be expressed as a rational function of s. For a transfer function with an nth-order numerator and an mth-order denominator, the general case is shown below. N and D are the coefficients for the numerator and denominator, respectively. The equation can be normalized so that the leading coefficient in the denominator is 1.

[0530]

[0531] or

[0532]

[0533] This equation can be rewritten as follows:

[0534]

[0535] Expressing this summation in matrix notation yields the following equation:

[0536]

[0537] Here k is the number of data points collected in the swept sine. To simplify notation, this equation can be summarized using a vector:

[0538] y=Xc[EQ#39]

[0539] Here the dimensions of y are k×1, X is k×(m+n-1), and c is (m+n-1)×1. The coefficients can then be found using the least squares method. The error function can be written as follows:

[0540] e=y-Xc[EQ#40]

[0541] The function to be minimized is the weighted square of the error function; W is a k×k diagonal matrix.

[0542] e T We = (y - Xc) T W(y-Xc) [EQ#41]

[0543] e T We=y T Wy-(y T WXc) T -y T WXc+c T x T WXc [EQ#42]

[0544] Since the middle two terms are scalars, the transpose can be ignored.

[0545] e T We=y T Wy-2y T WXc+c T x T WXc [EQ#43]

[0546]

[0547] c=(X T WX) -1 X T Wy [EQ#45]

[0548] In all of these cases it may be necessary to use the complex transpose. This method produces complex coefficients, but the process can be modified to ensure that all coefficients are real. The least squares minimization can be modified to give only real coefficients if the error function is changed to

[0549] e TWe=Re(y-Xc) T WRe(y-Xc)+Im(y-Xc) T WIm(y-Xc)[EQ#46]

[0550] Therefore, the coefficients can be obtained using the relationship:

[0551] c=(Re(X) T WRe(X)+Im(X) T WIm(X)) -1 (Re(X) T WRe(y)+Im(X) T WIm(y))

[0552] [EQ#47]

[0553] Solving the second-order system

[0554] For a system with a 0th-order numerator and a second-order denominator as shown in the transfer function:

[0555]

[0556] The coefficients in this transfer function can be obtained based on the expression obtained in the previous section: c = (Re(X) T WRe(X)+Im(X) T WIm(X)) -1 (Re(X) T WRe(y)+Im(X) T WIm(y))

[0557] [EQ#49]

[0558] in:

[0559]

[0560] To simplify the algorithm, we can combine some terms:

[0561] c=D -1 b [EQ#51]

[0562] in:

[0563] D=Re(X) T WRe(X)+Im(X) T WIm(X) [EQ#52]

[0564] b=Re(X) T WRe(y)+Im(X) T WIm(y) [EQ#53]

[0565] To derive an expression for D in terms of the complex response vector G and the natural frequency s = jω, X can be separated into its real and imaginary parts:

[0566]

[0567] The real and imaginary parts of the expression for D can then become:

[0568]

[0569]

[0570] Combining these terms produces a final expression for the D matrix, which may contain only real values.

[0571]

[0572] The same method can be used to obtain an expression for the b vector in terms of G and ω. The real and imaginary parts of y are as follows:

[0573]

[0574] Combining the real and imaginary parts yields the expression for the b vector:

[0575]

[0576] The next step is to invert the D matrix. This matrix is ​​symmetric and positive definite, so the number of calculations required to obtain the inverse can be reduced from the general 3×3 case. The general expression for matrix inversion is:

[0577]

[0578] If D is represented as follows:

[0579]

[0580] Then the transposed adjoint matrix can be written as follows:

[0581]

[0582] Due to symmetry, only the upper diagonal matrix may need to be calculated.

[0583] The determinant can then be calculated from the transposed adjoint matrix values, using the zero elements in the original array:

[0584] det(D)=a 12 d 12 +a 22 d 22 [EQ#63]

[0585] Finally, the inverse of D can be written as follows:

[0586]

[0587] Since we are trying to solve:

[0588]

[0589] So:

[0590]

[0591] The final step is to get a quantitative assessment of how well the data fits the model. Therefore, the original expression for the error is as follows:

[0592] e T We=Re(y-Xc) T WRe(y-Xc)+Im(y-Xc) T WIm(y-Xc)[EQ#67]

[0593] This can be expressed in terms of the D matrix and the b and c vectors as follows:

[0594] e T We=h-2c T b+c T Dc[EQ#68]

[0595] in:

[0596] h=Re(y T )WRe(y)+Im(y T )WIm(y)[EQ#69]

[0597]

[0598] Model matching errors can also be used to detect sensor failures.

[0599] Alternative solutions for second-order systems

[0600]

[0601] or

[0602]

[0603] This equation can be rewritten as follows:

[0604]

[0605] Substituting this sum into matrix notation gives:

[0606]

[0607] For a system with a 0th-order numerator and a second-order denominator as shown in the transfer function:

[0608]

[0609] The coefficients in this transfer function can be obtained based on the expressions obtained in the previous section:

[0610] c=(Re(X) T WRe(X)+Im(X) T WIm(X)) -1 (Re(X) T WRe(y)+Im(X) T WIm(y))

[0611] [EQ#76]

[0612] here

[0613]

[0614] To simplify the algorithm, some terms can be combined:

[0615] c=D -1 b[EQ#78]

[0616] in

[0617] D=Re(X) T WRe(X)+Im(X) T WIm(X) [EQ#79]

[0618] b=Re(X) T WRe(y)+Im(X) T WIm(y) [EQ#80]

[0619] To obtain an expression for D in terms of the complex response vector G and the natural frequency s = jω, X can be separated into its real and imaginary parts:

[0620]

[0621]

[0622] The real and imaginary parts of the expression for D above can then become:

[0623]

[0624] Combining these terms yields a final expression for the D matrix, which may contain only real values.

[0625]

[0626] The same method can be used to obtain an expression for the b vector in terms of G and ω. The real and imaginary parts of y are as follows:

[0627]

[0628] Combining the real and imaginary parts yields the expression for the b vector:

[0629]

[0630] Performing acoustic volume sensing

[0631] Collect frequency response data and calculate complex response

[0632] To implement volume sensor assembly 148, volume sensor assembly 148 should determine the relative responses of reference microphone 626 and variable volume microphone 630 to sound waves emitted by speaker assembly 622. This can be achieved by driving speaker assembly 622 with a sinusoidal output of a known frequency; the complex responses of microphones 626, 630 at this driving frequency can then be obtained. Finally, the relative responses of microphones 626, 630 can be obtained and corrected for AC sampling using, for example, an analog-to-digital converter (i.e., ADC).

[0633] Alternatively, the total signal variance can be calculated and compared to the variance of pure tones extracted using a discrete Fourier transform (DFT). This provides a measure of how much of the signal power comes from noise sources or distortion. This value can then be used to reject and repeat bad measurements.

[0634] Compute the discrete Fourier transform

[0635] The signal from the microphone can be sampled synchronously with the output to the speaker assembly 622, so that a fixed number of points are taken per wavelength, for example, N points. The measured signal at each point in the wavelength can be summed over the integer number of wavelengths M and stored in the array x by the ISR for processing after all data for that frequency has been collected.

[0636] The DFT can be performed on data at integer values ​​corresponding to the driving frequency of the speaker. The general expression of the fundamental wave of the DFT is as follows:

[0637]

[0638] The product MN can be the total number of points, and a factor of 2 can be added so that the real and imaginary parts of the resulting answer match the amplitude of the sine wave:

[0639]

[0640] The real part of this expression is as follows:

[0641]

[0642] We can use the symmetry of the cosine function to reduce the number of calculations required to calculate the DFT. The above expression can be equated to:

[0643]

[0644] Similarly, for the imaginary part of the equation:

[0645]

[0646] This can be expressed as follows:

[0647]

[0648] The variance of this signal can be calculated as follows:

[0649]

[0650] The maximum possible value of the real and imaginary parts of x can be 2 11 ; This corresponds to half the AD range. The maximum value of the pitch variance can be 2 21 ; Half the square of the AD range.

[0651] Calculate signal variance

[0652] The pseudovariance of a signal can be calculated using the following relationship:

[0653]

[0654] The result may be in units of squared AD counts. It may only be a "pseudo-variance" because the signal is averaged over M periods before the variance is calculated for N samples in the "averaging" period. However, it can be a useful metric to determine whether the "averaged" signal looks like a sinusoid at the expected frequency. This can be done by comparing the total signal variance with the variance of the sinusoid obtained in the discrete Fourier transform.

[0655] For a 12-bit ADC, the sum can be On the order of magnitude. If N<2 7 =128 and M<2 6 =64, then the sum will be less than 2 43 And can be stored as a 64-bit integer. If the ADC is between values ​​0 and 2 on each consecutive sample 12 The maximum possible value of the variance can be produced by oscillating between Therefore the result can be at most 1 / 2 9The resolution is stored as a signed 32-bit integer.

[0656] Calculating relative microphone response

[0657] The relative response (G) of microphones 626, 630 can be calculated from the composite responses of these individual microphones:

[0658]

[0659] Based on the reference pitch variance calculated in the previous section, the denominator of either expression can be expressed as follows:

[0660]

[0661] Correcting A / D offset

[0662] The signals from microphones 626, 630 may not be sampled simultaneously; the A / D ISR alternates between microphones 626, 630, taking a total of N samples per wavelength for each of microphones 626, 630. As a result, there may be N samples between the two microphones 626, 630. To correct for this phase shift, a complex rotation can be applied to the relative frequency response calculated in the previous section:

[0663]

[0664] Reference Model

[0665] Second-order and higher-order models

[0666] Leakage through a seal (e.g., seal assembly 1404) of volume sensor chamber 620 may be modeled as being connected to an external volume (e.g., external volume 1506, Figure 100 ) of the second resonant port (eg, port 1504, Figure 100 ).

[0667] The equations describing this three-chamber configuration can be expressed as follows:

[0668]

[0669]

[0670]

[0671]

[0672]

[0673] Substituting these equations into the state space yields the following:

[0674]

[0675] Its frequency response can be graphically represented in the Bode plot shown in Figure 101 and it can also be written in the form of a transfer function:

[0676]

[0677] Expanding the denominator gives the following:

[0678]

[0679] The air bubble under the diaphragm material in the variable volume will follow the same dynamic equation as the leakage path. In this case, the diaphragm material can be used as a resonant mass rather than a leakage port. Thus, the equation can be as follows:

[0680]

[0681] where m is the mass of the diaphragm, A is the cross-sectional area where the diaphragm can resonate, and b m is the mechanical damping. EQ#106 can be written in terms of the volume flow rate:

[0682]

[0683] where the volume of the air bubble is V3. If the air bubble volume is significantly smaller than the acoustic volume V3 << V2, then the transfer function can be simplified to:

[0684]

[0685] Second order with time delay

[0686] The equation for the volume sensor assembly 所获得的148 above assumes that the pressure is the same at any position in the acoustic volume. This is only an approximation because there is a time delay associated with the propagation of the sound wave through the volume. Depending on the relative positions of the microphone and the speaker, this situation can appear as a time delay or a time advance.

[0687] The time delay can be represented in the Laplace domain as:

[0688] G(s) = e -ΔTs [EQ#112]

[0689] This can form a set of non-linear equations. However, the first-order Pade approximation of the time delay can be used as follows:

[0690]

[0691] This is shown graphically in Figure 102 中所示的波特图中图解表示,并且其也可以写成传递函数的形式:

[0692] Three-chamber volume estimation 请注意,原文中部分内容可能表述不够清晰准确,翻译时尽量忠实于原文进行了呈现。其中“上面获得的容积传感器组件148方程假设压强在声学容积中的任何位置都是相同的。这仅仅为近似,因为具有与声波通过该容积的传播有关的时间延迟。基于麦克风和扬声器的相对位置,此情形可看似时间延迟或时间提前。”这部分内容在逻辑上可能需要进一步梳理,但按照要求保留了原文表述。

[0693] Alternatively, independent resonant ports (e.g., port 1510; Figure 103 ) is connected to a third reference volume (e.g., reference volume 1508; Figure 103 ) to construct volume sensor assembly 148. This configuration enables temperature-independent volume estimation.

[0694] The system of equations describing the three-chamber configuration is as follows:

[0695]

[0696]

[0697]

[0698]

[0699]

[0700] Using these equations and solving for the transfer function across each of the resonant ports yields the following:

[0701]

[0702] in

[0703]

[0704] in

[0705]

[0706] The volume of volume sensor chamber 620 can be estimated using the ratio of the natural frequencies of the two resonant ports as follows:

[0707]

[0708] EQ #120 shows that the volume of volume sensor chamber 620 may be proportional to reference volume 1508. The ratio of these two volumes (in an ideal model) may depend only on the resonant ports (e.g., port 1510; Figure 103 ) geometry and is independent of temperature.

[0709] Exponential Volume Model

[0710] Assume that the outflow through the flow resistance has the following form:

[0711]

[0712] Assuming a fixed input flow rate from the pump chamber, the volume of volume sensor chamber 620 is based on the following differential equation:

[0713]

[0714] Assuming zero initial volume, this gives the following solution:

[0715]

[0716] Therefore, the output flow rate is:

[0717]

[0718] The volume delivered during the pumping phase can be written as:

[0719]

[0720] Device calibration

[0721] Model matching allows the resonant frequency of the port to be extracted from the sine sweep data. The next step is to relate this value to the delivered volume. The ideal relationship between the resonant frequency and the delivered volume is expressed as follows:

[0722]

[0723] The speed of sound will change with temperature, so it may be useful to factor out the temperature effect.

[0724]

[0725] This volume can then be expressed as a function of the measured resonant frequency and temperature:

[0726]

[0727] where c is the calibration constant

[0728] Implementation details

[0729] End Effect

[0730] Air resonating in a port (e.g., port assembly 624) can expand into the acoustic volume at the end of each oscillation. The distance the air expands can be estimated based on the basic volume sensor assembly equation. For any given acoustic volume, the distance the air expands into that volume can be expressed as a function of pressure and the port cross-sectional area:

[0731]

[0732] If we assume the following values:

[0733] V = 28.8 × 10 -6 L[EQ#133]

[0734]

[0735] d=0.5mm [EQ#136]

[0736] p = 1 Pa (approximately 100 dB) [EQ#137]

[0737] Therefore, the air will expand approximately 1.9 mm into the acoustic chamber.

[0738] Dimension V1 (i.e. fixed volume) relative to V2 (i.e. variable volume)

[0739] Sizing V1 (e.g., fixed volume 1500) may require trading off acoustic volume with the relative positions of poles and zeros in the transfer function. The transfer functions for V1 and V2 (e.g., variable volume 1502) are shown below in relation to the volume displacement of the speaker assembly 622.

[0740]

[0741] in

[0742]

[0743] As V1 increases, the gain can be reduced, and the loudspeaker can be driven at a higher amplitude to achieve the same sound pressure level. However, increasing V1 can also have the benefit of moving the complex zero in the p1 transfer function toward the complex pole. In the extreme case, V1 → ∞, α → 1, and pole-zero cancellation and a flat response are achieved. Therefore, increasing V1 can have the following benefits: reducing resonances and notches in the p1 transfer function and moving it toward ω n Moves the p2 pole; this results in less sensitivity to measurement errors when calculating the p2 / p1 transfer function.

[0744] Figure 104 The following diagram shows:

[0745]

[0746] Figure 105 The following diagram shows:

[0747]

[0748] Aliasing

[0749] Higher frequencies may alias down to the frequency of interest, where the aliased frequency can be expressed as follows:

[0750] f=|f n -nf s | [EQ#143]

[0751] where fs is the sampling frequency, f n is the frequency of the noise source, n is a positive integer, and f is the aliasing frequency of the noise source.

[0752] The demodulation routine effectively filters out noise except at the specific frequency of the demodulation. If the sampling frequency is dynamically set to a fixed multiple of the demodulation frequency, the frequencies of the noise that can be mixed down to the demodulation frequency can be a fixed set of harmonics of this fundamental frequency.

[0753] For example, if the sampling frequency is eight times the demodulation frequency, the noise frequencies that can alias down to this frequency are as follows:

[0754]

[0755] in For β = 16, the following series will be generated:

[0756]

[0757] performance

[0758] Sensitivity to temperature

[0759] The sensitivity to temperature can be divided into gain variation and noise variation. If the temperature differs by a factor of dT, the resulting gain error can be:

[0760]

[0761] Therefore, if the same temperature is used for both sinusoidal sweeps, any error in the temperature measurement may appear as a gain change to the system.

[0762]

[0763] Thus, for a temperature error of 1° K, the resulting volume error at 298° K may be 0.3%. This error may include errors in the temperature sensor and the difference between the sensor temperature and the temperature of the air within volume sensor assembly 148 .

[0764] However, in temperature measurements, the measurement can be more susceptible to noise. Temperature changes during a differential sine sweep can produce errors that look more like offset than gain changes.

[0765]

[0766] Therefore, if the measurement changes by 0.1K during two measurement sine sweeps, the difference may be 0.012uL. Therefore, it may be better to use a consistent temperature estimate for each delivery rather than taking an independent temperature measurement for each sine sweep (e.g. Figure 107 ).

[0767] The LM73 temperature sensor has a published accuracy of + / - 1°C and a resolution of 0.03°C. In addition, the LM73 temperature sensor appears to consistently have a startup transient of approximately 0.3°C that takes approximately five sine sweeps to flatten out (as shown in the example). Figure 108 ).

[0768] Because the above-described infusion pump assemblies (e.g., infusion pump assemblies 100, 100', 400, 500) provide discontinuous delivery of the infusible fluid, the infusible fluid may be delivered in discrete domains (e.g., Figure 109 The above infusion pump assembly is fully modeled using the approach shown in , which can be simplified as follows:

[0769]

[0770] The discrete-time PI regulator can be implemented as follows:

[0771]

[0772] The AVS system described above operates by comparing the acoustic responses in fixed volume 1500 and variable volume 1502 with the speaker drive input and extracting the volume of variable volume 1502. Thus, a microphone (e.g., microphones 626, 630) is provided in contact with each of these independent volumes. Furthermore, the response of variable volume microphone 630 can be used in a more coarse manner to detect the presence or absence of disposable housing assembly 114. Specifically, if disposable housing assembly 114 is not attached to variable volume 1502 (i.e., positioned near variable volume 1502), substantially no acoustic response to the speaker drive input should be detected. However, the response of fixed volume 1500 should remain correlated with the speaker input. Thus, simply by ensuring that both microphones exhibit an acoustic response, the microphone data can be used to determine whether disposable housing assembly 114 is present. If microphone 626 (i.e., the microphone positioned near fixed volume 1500) exhibits an acoustic response and microphone 630 (i.e., the microphone positioned near variable volume 1502) does not exhibit an acoustic response, it may be reasonable to infer that disposable housing assembly 114 is not attached to reusable housing assembly 102. It should be noted that a malfunction of variable volume microphone 630 may also appear to indicate that disposable housing assembly 114 is not attached, as a malfunction of variable volume microphone 630 may produce a mid-range reading that is barely distinguishable from the expected microphone response when disposable housing assembly 114 is not attached.

[0773] For the following discussion, the following terminology will be used:

[0774]

[0775] As part of the demodulation routine employed in each frequency response calculation, the minimum and maximum readings may be calculated for fixed volume microphone 626 and variable volume microphone 630. The sum of these maximum and minimum values ​​may be calculated over the entire sine sweep (as described above) for microphone 626 and microphone 630 as follows:

[0776]

[0777] The difference between these two sums can be simplified as follows:

[0778] δ=σmax-σmin[EQ#154]

[0779] Although one can divide δ by the number of sine sweeps to obtain the average minimum / maximum difference of the sine sweeps (which can then be compared to a threshold), for computational efficiency one can equivalently multiply this threshold by N. Thus, the basic one-shot detection algorithm can be defined as follows:

[0780]

[0781] An additional condition that the maximum / minimum difference is greater than a threshold is a test that is performed to ensure that a faulty speaker is not the cause of the received acoustic response. This algorithm can be repeated for any sine sweep, thereby allowing detachment of disposable housing assembly 114 to be sensed within, for example, at most two consecutive sweeps (i.e., in the worst case scenario where disposable housing assembly 114 is removed during the second half of an ongoing sine sweep).

[0782] The thresholds used for the above algorithm may be based entirely on numerical examples. For example, a typical examination of the minimum / maximum response differences may indicate that no single difference is less than five hundred ADC counts. Thus, an examination of all data when disposable housing assembly 114 is separated from reusable housing assembly 102 may indicate that all minimum / maximum response differences are definitely below five hundred ADC counts. Thus, the threshold for δ may be set at T=500.

[0783] Although volume sensor assembly 148 is described above as being used within an infusion pump assembly (e.g., infusion pump assembly 100), this is for illustrative purposes only and is not intended to be limiting of the present disclosure, as other configurations are possible and considered within the scope of the present disclosure. For example, volume sensor assembly 148 may be used within a process control environment for, for example, controlling the amount of chemicals being mixed together. Alternatively, volume sensor assembly 148 may be used within a beverage dispensing system to control the amount of ingredients being mixed together, for example.

[0784] Although volume sensor assembly 148 is described above as using a port (e.g., port assembly 624) as a resonator, this is for illustrative purposes only, as other configurations are possible and are considered within the scope of this disclosure. For example, a solid block (not shown) may be suspended within port assembly 624 and may serve as a resonator for volume sensor assembly 148. Specifically, the block (not shown) for the resonator may be suspended from a diaphragm (not shown) that spans port assembly 624. Alternatively, the diaphragm itself (not shown) may serve as the block for the resonator. The natural frequency of volume sensor assembly 148 may be a function of variable volume 1502. Therefore, if the natural frequency of volume sensor assembly 148 can be measured, the volume of variable volume 1502 can be calculated.

[0785] The natural frequency of volume sensor assembly 148 can be measured in a variety of different ways. For example, a time-varying force may be applied to a diaphragm (not shown), and the relationship between this force and the motion of the diaphragm (not shown) may be used to estimate the natural frequency of volume sensor assembly 148. Alternatively, the mass (not shown) may be perturbed and then allowed to oscillate. The unforced motion of the mass (not shown) may then be used to calculate the natural frequency of volume sensor assembly 148.

[0786] The force applied to the resonant mass (not shown) may be achieved in various ways, examples of which may include but are not limited to:

[0787] The speaker assembly 622 can generate a time-varying pressure within the fixed volume 1500;

[0788] • The resonant mass (not shown) may be a piezoelectric material that responds to a time varying voltage / current; and

[0789] • The resonant mass (not shown) may be a voice coil that responds to a voltage / current that varies with time.

[0790] The force applied to the resonant mass can be measured in various ways, examples of which may include, but are not limited to:

[0791] ●Measure the pressure in a fixed volume;

[0792] • The resonant mass (not shown) may be a piezoelectric material; and

[0793] • The strain gauges may be connected to the diaphragm (not shown) or other structural members supporting the resonant mass (not shown).

[0794] Similarly, the displacement of the resonant mass (not shown) may be estimated by measuring the pressure in the variable volume or directly measured in various ways, examples of which may include but are not limited to:

[0795] ●Via piezoelectric sensor;

[0796] ●via capacitive sensors;

[0797] ● Via optical sensor;

[0798] ●Via Hall effect sensor;

[0799] Via potentiometer (time-varying impedance) sensors;

[0800] ● via inductive sensors; and

[0801] ● Via a linear variable differential transformer (LVDT).

[0802] Furthermore, the resonant mass (not shown) may be integral with the force or displacement sensor (ie, the resonant mass (not shown) may be made of a piezoelectric material).

[0803] The application of force and the measurement of displacement can be achieved using a single device. For example, a piezoelectric material can be used for a resonant mass (not shown), and a time-varying voltage / current can be applied to the piezoelectric material to generate a time-varying force. The resulting voltage / current applied to the piezoelectric material can be measured, and the transfer function between the two can be used to estimate the natural frequency of volume sensor assembly 148.

[0804] As described above, the resonant frequency of volume sensor assembly 148 can be estimated using swept sine system identification. Specifically, the model matching described above can allow the resonant frequency of the port assembly to be extracted from the swept sine data, which can then be used to determine the delivered volume. The ideal relationship between resonant frequency and delivered volume can be expressed as follows:

[0805]

[0806] The speed of sound will change with temperature, so splitting out the temperature effect may be beneficial.

[0807]

[0808] This volume can then be expressed as a function of the measured resonant frequency and temperature:

[0809]

[0810] where c is the calibration constant

[0811] Infusion pump assembly 100 may then compare this calculated volume V2 (i.e., representing the actual volume of the infusible fluid delivered to the user) to the target volume (i.e., representing the amount of fluid intended to be delivered to the user). For example, assume that infusion pump assembly 100 will deliver a basal dose of 0.100 units of infusible fluid to the user every thirty minutes. Furthermore, assume that after this delivery is complete, volume sensor assembly 148 indicates a calculated volume V2 of 0.095 units of infusible fluid (i.e., representing the actual volume of the infusible fluid delivered to the user).

[0812] When calculating volume V2, infusion pump assembly 100 may first determine the volume of fluid within volume sensor chamber 620 before administering the dose of infusible fluid, and may subsequently determine the volume of fluid within volume sensor chamber 620 after administering the dose of infusible fluid, where the difference between those two measurements represents V2 (i.e., the actual volume of infusible fluid delivered to the user). V2 is therefore a difference measurement.

[0813] V2 can be the total air space above the diaphragm in the variable volume chamber. The actual fluid delivery to the patient can be the difference in V2 from when the chamber is full to after the measuring valve is opened and the chamber is emptied. V2 may not be exactly the delivered volume. For example, the air volume can be measured and a series of differential measurements can be taken. For an obstruction, an emptying measurement can be taken, the chamber can be filled, a full measurement can be taken, and then a final measurement can be taken after the outlet valve is opened. Thus, the difference between the first and second measurements can be the amount pumped, while the difference between the second and third measurements is the amount delivered to the user.

[0814] Thus, electrical control assembly 110 may determine that the infusible fluid delivered is 0.005 units less than the infusible fluid requested to be delivered. In response to this determination, electrical control assembly 110 may provide an appropriate signal to mechanical control assembly 104 so that any additional required dose can be pumped. Alternatively, electrical control assembly 110 may provide an appropriate signal to mechanical control assembly 104 so that the additional dose can be dispensed with the next dispensing. Thus, during the administration of the next 0.100 unit dose of infusible fluid, the output command for the pump may be modified based on the difference between the target amount and the delivered amount.

[0815] In addition, refer to Figure 110, shows one specific embodiment of a control system for controlling the amount of infusible fluid currently being infused based, at least in part, on the amount of infusible fluid previously administered. Specifically, and continuing with the above example, for illustrative purposes, assume that electrical control assembly 110 requests that a 0.100 unit dose of infusible fluid be delivered to a user. Accordingly, electrical control assembly 110 may provide a target differential volume signal 1600 to volume controller 1602 (which identifies the partial basal dose of 0.010 units of infusible fluid provided with each cycle of shape memory actuator 112). Therefore, and in this particular example, shape memory actuator 112 may need to cycle ten times to achieve the desired basal dose of 0.100 units of infusible fluid (i.e., 10 cycles x 0.010 units / cycle = 0.100 units). Volume controller 1602, in turn, may provide an "on-time" signal 1606 to SMA (i.e., shape memory actuator) controller 1608. Additionally, a battery voltage signal 1610 is provided to the SMA controller 1608 .

[0816] Specifically, shape-memory actuator 112 can 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 decreases, the amount of joules applied to shape-memory actuator 112 may also decrease for a defined period of time. Conversely, if the voltage level of battery 606 increases, the amount of joules applied to shape-memory actuator 112 may also increase 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 can be varied to ensure that an appropriate amount of thermal energy is applied to shape-memory actuator 112, regardless of the battery voltage level.

[0817] 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 SMA drive signal 1612 may be a series of binary pulses, wherein the amplitude of SMA drive signal 1612 substantially controls the stroke length of shape-memory actuator 112 (and therefore pump assembly 106), and the duty cycle of SMA drive signal 1612 substantially controls the stroke speed of shape-memory actuator 112 (and therefore pump assembly 106). Furthermore, because SMA drive signal 1612 indicates a 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 (as described above) ten cycles of shape memory actuator 112 (at 0.010 units / cycle) may be required to infuse 0.100 units of infusible fluid, discrete-time integrator 1614 may integrate SMA drive signal 1612 over these ten cycles to determine the total amount of infusible fluid infused (as represented by volume signal 1616).

[0818] SMA drive signal 1612 may actuate pump assembly 106, for example, within one cycle, resulting in the filling of volume sensor chamber 620 included within volume sensor assembly 148. Infusion pump assembly 100 may then perform a first measurement of the amount of fluid included within volume sensor chamber 620 (as described above). Additionally and as described above, measurement valve assembly 610 may subsequently be actuated, resulting in all or a portion of the fluid within volume sensor chamber 620 being delivered to the user. Infusion pump assembly 100 may then perform a measurement of the amount of fluid included within volume sensor chamber 620 (as described above) and use those 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.

[0819] Continuing with the above example, where the differential target volume is 0.010 units of infusible fluid, assume that V2 (i.e., as represented by signal 1618) identifies that 0.009 units of infusible fluid have been delivered to the user. Accordingly, infusion pump assembly 100 may increase the next differential target volume to 0.011 units to compensate for the previous shortfall of 0.001 units. Therefore, and as described above, when the next basal dose of infusible fluid is delivered to the user, the amplitude and / or duty cycle of SMA drive signal 1612 may be increased. This process may be repeated for the remaining nine cycles of shape memory actuator 112 (as described above), and discrete-time integrator 1614 may continue to integrate SMA drive signal 1612 (to generate volume signal 1616), which may define the total amount of infusible fluid delivered to the user.

[0820] In addition, refer to Figure 111 , shows one possible embodiment of volume controller 1602. In this particular embodiment, volume controller 1602 may include a PI (proportional-integral) controller 1650. Volume controller 1602 may include a feedforward controller 1652 for setting an initial "guess" regarding "on time" signal 1606. For example, for the scenario described above where target differential volume signal 1600 identifies a partial basal dose of 0.010 units of infusible fluid per cycle of shape memory actuator 112, feedforward controller 1652 may define an initial "on time" of, for example, one millisecond. Feedforward controller 1652 may include, for example, a lookup table that defines an initial "on time" based at least in part on target differential volume signal 1600. Volume controller 1602 may also include a discrete-time integrator 1654 for integrating target differential volume signal 1600 and a discrete-time integrator 1656 for integrating V2 (i.e., as represented by signal 1618).

[0821] In addition, refer to Figure 112 , shows one possible embodiment of a feedforward controller 1652. In this particular embodiment, 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.

[0822] As described above, pump assembly 106 may be controlled by shape memory actuator 112. Additionally and as described above, 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.

[0823] In addition, refer to Figures 113-114 , shows one particular embodiment of an SMA controller 1608. As described above, the SMA controller 1608 may be responsive to the "on time" signal 1606 and the battery voltage signal 1610 and may provide an SMA drive signal 1612 to the shape memory actuator 112. The SMA controller 1608 may include a feedback loop (including a unit delay 1700), the output of which may be multiplied with the battery voltage signal 1610 at a multiplier 1702. The output of the multiplier 1702 may be amplified, for example, using a unity gain amplifier 1704. The output of the amplifier 1704 may be applied to the negative input of a summing node 1706 (to which the "on time" signal 1606 is applied). The output of the summing node 1706 may be amplified (via, for example, the unity gain amplifier 1708). The SMA controller may also include a feedforward controller 1710 (in a manner similar to the feedforward controller 1652 of the volume controller 1602; see Figure 112 The output of the feedforward controller 1710 may be summed at a summing node 1712 with the output of the amplifier 1708 and an integrated representation of the output of the amplifier 1708 (ie, signal 1714 ) to form the SMA drive signal 1612 .

[0824] SMA drive signal 1612 can be provided to control circuitry for effecting the application of energy to shape-memory actuator 112. For example, SMA drive signal 1612 can be applied to switch assembly 1716, which can selectively apply current signal 1718 (provided by battery 606) and / or fixed signal 1720 to the shape-memory actuator. For example, SMA drive signal 1612 can implement the application of energy (supplied from battery 606 via current signal 1718) via switch assembly 1716 at a duty cycle defined by SMA drive signal 1612. Unit delay 1722 can generate a delayed version of the signal applied to shape-memory actuator 112 to form battery voltage signal 1610 (which can be applied to SMA controller 1608).

[0825] When power is applied to shape-memory actuator 112, the voltage may be applied for a fixed amount of time and: a) with an unregulated voltage at a fixed duty cycle; b) with a regulated voltage at a fixed duty cycle; c) with a variable duty cycle based on a measured current value; d) with a variable duty cycle based on a measured voltage value; and e) with a variable duty cycle based on the square of the measured voltage value. Alternatively, the voltage may be applied to shape-memory actuator 112 for a variable amount of time based on the measured impedance.

[0826] When an unregulated voltage is applied at a fixed duty cycle for a fixed amount of time, the 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.

[0827] When applying the regulated voltage at a fixed duty cycle for a fixed amount of time, the inner loop feedback may not be used and shape memory actuator 112 may be driven at a fixed duty cycle and with an on time determined by the outer volume loop.

[0828] When applying an unregulated voltage with a variable duty cycle based on the measured current value, the actual current applied to shape memory actuator 112 may be measured and the duty cycle may be adjusted during actuation of shape memory actuator 112 to maintain the correct average current.

[0829] When applying an unregulated voltage with a variable duty cycle based on a measured voltage value, the actual voltage applied to shape memory actuator 112 may be measured and the duty cycle may be adjusted during actuation of shape memory actuator 112 to maintain the correct average voltage.

[0830] When an unregulated voltage is applied at a variable duty cycle that is based on the square of the measured voltage value, the actual voltage applied to shape memory actuator 112 may be measured, and the duty cycle may be adjusted during actuation of shape memory actuator 112 to maintain the square of the voltage at a desired level to provide a desired level of power to shape memory actuator 112 (based on the impedance of shape memory actuator 112).

[0831] In addition, refer to Figures 114A-114B , shows other embodiments of the SMA controller 1608. Specifically, Figure 114A114B is an electrical schematic diagram that includes a microprocessor and various control circuits. The microprocessor and control circuits can be configured to provide a PWM signal that can open and close a switch assembly. The switch assembly can control the current allowed to flow through the shape memory actuator. A battery can provide current to the shape memory actuator. Furthermore, 114B discloses a volume controller and an internal shape memory actuator controller. The shape memory actuator controller can provide a PWM signal to the pump that can be modified based on the battery voltage. This can occur for a fixed operating time, resulting in volume that can be measured by volume sensor assembly 148 and fed back to the volume controller.

[0832] In a preferred embodiment, the duty cycle is varied based on the measured battery voltage to provide approximately consistent power. The duty cycle is adjusted to compensate for low battery voltage. Battery voltage can vary for two reasons: 1) as the battery discharges, the voltage slowly decreases; and 2) when a load is applied to the battery, it has internal impedance, so its voltage drops. This happens in any type of system, and we compensate for it by adjusting the duty cycle, thereby slowing down the decrease or change in battery voltage. The battery voltage can be measured by a microprocessor. In other systems: 1) the voltage can be regulated (a regulator is placed to keep it at a stable voltage); 2) based on feedback from something else (i.e., the speed or position of the motor, which does not necessarily require measuring the battery voltage).

[0833] Other configurations can be used to control shape memory actuators. For example: A) The shape memory actuator can be controlled using an unregulated voltage at a fixed duty cycle. As the voltage changes, the repeatability of heating the shape memory actuator decreases. B) A fixed duty cycle and regulated voltage can be used to compensate for changes in battery voltage. However, due to the energy of the energy, lowering the voltage is not as effective. C) The duty cycle can be changed based on changes in current (which may require more complex measurement circuitry). D) The duty cycle can be changed based on the measured voltage. E) The duty cycle can be changed based on the square of the current or the square of the voltage divided by the resistance. F) The voltage can be applied for a variable amount of time based on the measured impedance (for example, the impedance can be measured using a Wheatstone meter (not shown)). The impedance of the shape memory actuator can be correlated to the strain (i.e., how much the SMA can be moved is correlated to the impedance of the SMA).

[0834] In addition, refer to Figure 115As described above, to enhance the safety of infusion pump assembly 100, electrical control assembly 110 may include two independent and distinct microprocessors: supervisor processor 1800 and command processor 1802. Specifically, command processor 1802 may perform the functions described above (e.g., generating SMA drive signal 1612) and may control relay / switch assemblies 1804 and 1806, which (respectively) control the functions of shape memory actuators 112 and 632 (in this example). 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 and 632. Command processor 1800 may control relay / switch assembly 1810 independently of relay / switch assemblies 1804 and 1806. Therefore, when an infusion event is expected, both supervisor processor 1800 and command processor 1802 must agree that the infusion event is correct and must both actuate their respective relays / switches. If either supervisor processor 1800 or command processor 1802 fails to actuate their respective relays / switches, an infusion event will not occur. Thus, through the use of supervisor processor 1800 and command processor 1802 and the coordination and concurrency that must occur, the safety of infusion pump assembly 100 is enhanced.

[0835] The supervisor processor can prevent the command processor from delivering when it thinks it should not, and can also issue a warning if the command processor does not deliver when it should. The supervisor processor can disable the relay / switch assembly if the command processor actuates the wrong switch, or if the command processor attempts to apply power for too long.

[0836] The supervisor processor can redundantly perform calculations on how much insulin should be delivered (ie, double checking the command processor's calculations). The command processor can determine the delivery plan, and the supervisor processor can redundantly check those calculations.

[0837] In addition the manager also saves the delivery profile redundantly in RAM so the command processor may make correct calculations but if it has bad RAM it will cause the command to give wrong results. The manager uses a local copy of its base delivery profile etc for double checking.

[0838] Administrators can double-check AVS measurements, review AVS calculations and perform safety checks. Every time an AVS measurement is taken, it is double-checked.

[0839] In addition, refer to Figure 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) sensed at, for example, the distal end of shape memory actuator 112. The values ​​of voltages V1 and V2, combined with knowledge of the signals applied to relay / switch assemblies 1804, 1810, may allow for the monitoring of the infusion pump assembly 100. Figure 116 Diagnostics are performed on the various components of the circuit shown in (in a manner similar to that shown in illustrative diagnostic table 1816).

[0840] As mentioned above and as Figures 115-116 As shown in , to enhance 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 need to interact and cooperate in order to complete the delivery of a dose of the infusible fluid. If the microprocessors fail to interact / cooperate, the delivery of the dose of the infusible fluid may fail and one or more alarms may be triggered, thereby enhancing the safety and reliability of infusion pump assembly 100.

[0841] A master alert can be used that tracks volume errors over time. Thus, if the sum of the errors becomes too large, a master alert can be issued, indicating a possible system error. Thus, a master alert can indicate that a total volume comparison is being performed and a discrepancy has been noted. A typical discrepancy value required to initiate a master alert might be 1.00 ml. The master alert can monitor this sum in a leaky manner (i.e., the errors have a timeframe).

[0842] In addition, refer to Figures 117A-117B , shows one illustrative example of this interaction between multiple microprocessors during the delivery of a dose of an infusible fluid. Specifically, command processor 1802 may first determine 1900 the initial volume of infusible fluid within volume sensor chamber 620. Command processor 1802 may then provide 1902 a "Pump Power Request" message to supervisor processor 1800. Upon receiving 1904 this "Pump Power Request" message, supervisor processor 1800 may, for example, energize 1906 relay / switch 1810 (thereby energizing shape memory actuator 112) and may send 1908 a "Pump Power On" message to command processor 1802. After receiving 1910 this "Pump Power On" message, command processor 1802 may actuate 1912, for example, pump assembly 106 (by energizing relay / switch 1804), during which supervisor processor 1800 may monitor 1914 the actuation of, for example, pump assembly 106.

[0843] Once actuation of pump assembly 106 is complete, command processor 1802 may provide 1914 a "Pump Power Off" message to supervisor processor 1800. Upon receiving 1916 the "Pump Power Off" message, supervisor processor 1800 may disconnect 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 amount of infusible fluid pumped by pump assembly 106. This may be accomplished by measuring the current amount of fluid within volume sensor chamber 620 and comparing it to the amount determined above (in step 1900). Upon determining 1924, command processor 1802 may provide 1926 a "Valve Open Power Request" message to supervisor processor 1800. After receiving 1928 the “Valve Open Power Request” message, supervisor processor 1800 may energize 1930 relay / switch 1810 (thereby energizing shape memory actuator 632) and may send 1932 a “Valve Open Power On” message to command processor 1802. After receiving 1934 the “Valve Open Power On” message, command processor 1802 may actuate 1936, for example, measurement valve assembly 610 (by energizing relay / switch 1806), during which supervisor processor 1800 may monitor 1938 the actuation of, for example, measurement valve assembly 610.

[0844] Once actuation of measurement valve assembly 610 is complete, command processor 1802 may provide 1940 a “Valve De-energized” message to supervisor processor 1800. After receiving 1942 the “Valve De-energized” message, supervisor processor 1800 may open 1944 relay / switch 1810 and provide 1946 a “Valve De-energized” message to command processor 1802.

[0845] After receiving 1948 the “Valve Power Off” message, command processor 1802 may provide 1950 a “Valve Close Power Request” message to supervisor processor 1800. After receiving 1952 the “Valve Close Power Request” message, supervisor processor 1800 may energize 1954 relay / switch 1810 (thereby energizing shape-memory actuator 652) and may send 1956 a “Power On” message to command processor 1802. After receiving 1958 the “Power On” message, command processor 1802 may actuate 1960 an energizing relay / switch (not shown) configured to energize shape-memory actuator 652, during which supervisor processor 1800 may monitor 1962 the actuation of, for example, shape-memory actuator 652.

[0846] As mentioned above (and temporarily referring to Figure 26A 、 26B, 27A, 27B, and 28), shape memory actuator 652 may be anchored at a first end using electrical contacts 654. The other end of shape memory actuator 652 may be connected to a bracket assembly 656. When shape memory actuator 652 is activated, it may pull bracket assembly 656 forward and release valve assembly 634. In this manner, measurement valve assembly 610 may be activated via shape memory actuator 632. Once measurement valve assembly 610 has been activated, bracket assembly 656 may automatically lock valve assembly 610 in the activated position. Actuating shape memory actuator 652 may pull bracket assembly 656 forward and release valve assembly 634. Assuming shape memory actuator 632 is no longer activated, measurement valve assembly 610 may move to a deactivated state once bracket assembly 656 releases valve assembly 634. Thus, actuating shape memory actuator 652 may deactivate measurement valve assembly 610.

[0847] Once actuation of shape-memory actuator 652 is complete, command processor 1802 may provide 1964 a “power off” message to supervisor processor 1800. After receiving 1966 the “power off” message, supervisor processor 1800 may open 1968 relay / switch 1810 and may provide 1970 a “power off” message to command processor 1802. After receiving 1972 the “power off” message, command processor 1802 may determine the amount of infusible fluid within volume sensor chamber 620, thereby allowing command processor 1802 to compare this measured amount with the amount determined above (in step 1924) to determine 1974 the amount of infusible fluid to deliver to the user.

[0848] If the amount of infusible fluid delivered 1974 to the user is less than the amount of infusible fluid specified for the basal / bolus infusion event, the above process may be repeated (via circuit 1976).

[0849] In addition, refer to Figure 118, shows another illustrative example of the interaction between processors 1800, 1802 during the scheduling of a dose of an infusible fluid. Command processor 1802 may monitor 2000, 2002 for the receipt of a basal scheduling message or a bolus request message (respectively). Upon receiving 2000, 2002 either of these messages, command processor 1802 may set 2004 a desired delivery volume 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 defined 2004 by command processor 1802. Once verified 2010, supervisor processor 1800 may provide 2012 a "delivery accepted" message to command processor 1802. Upon receiving 2014 the "delivery accepted" message, command processor 1802 may send a request to a controller (e.g., as discussed above and in Figure 110 ) updates 2016 and executes 2018 the delivery of a basal / bolus dose of the infusible fluid. Command processor 1808 may monitor and update 2022 the total amount of infusible fluid delivered to the user (as described above and in Figures 117A-117B ). Once the appropriate amount of infusible fluid has been delivered to the user, command processor 1802 may provide 2024 a "delivery complete" message to supervisor processor 1800. After receiving 2026 the "delivery complete" message, supervisor processor 1800 may update 2028 the total amount of infusible fluid delivered to the user. If the total amount of infusible fluid delivered 2018 to the user is less than the amount defined above (in step 2004), the above-described infusion process may be repeated (via loop 2030).

[0850] In addition, refer to Figure 119 , shows an example of the manner in which supervisor processor 1800 and command processor 1802 may interact while implementing volume measurements via volume sensor assembly 148 (as described above).

[0851] Specifically, command processor 1802 may initialize 2050 volume sensor assembly 148 and begin collecting 2052 data from volume sensor assembly 148. This process may be repeated for each frequency used in the sinusoidal sweep described above. Each time this data is collected for a particular sweep frequency, a data point message may be provided 2054 from command processor 1802, which may be received 2056 by supervisor processor 1800.

[0852] Once data collection 2052 for the entire sine sweep is complete, command processor 1802 may estimate 2058 the volume of the 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 the volume estimate message, supervisor processor 1800 may review (e.g., validate) 2064 the volume estimate message. Once reviewed (i.e., validated), supervisor processor 1800 may provide 2066 a verification message to command processor 1802. Upon receiving 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.

[0853] As described above and with temporary reference to FIG11 , the various embodiments of the infusion pump assembly discussed above (e.g., infusion pump assembly 100, 100', 400, 500) can be configured via remote control assembly 300. When configurable via remote control assembly 300, the infusion pump assembly can include telemetry circuitry (not shown) that allows for communication (e.g., wired or wireless) between the infusion pump assembly and, for example, remote control assembly 300, thereby 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 be capable of communicating with the infusion pump assembly) can include display assembly 302 and input assembly 304. Input assembly 304 can include slider assembly 306 and switch assemblies 308, 310. In other embodiments, the input assembly can include a scroll wheel, multiple switch assemblies, etc. Remote control assembly 300 can allow a user to program basal and bolus delivery events.

[0854] Remote control assembly 300 may include two processors, one processor (e.g., which may include, but is not limited to, a CC2510 microprocessor / RF transceiver available from Chipcon AS of Oslo, Norway) may be dedicated to radio communications, e.g., for communicating 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 of the United Kingdom) may be a command processor and may perform data processing tasks associated with, for example, configuring infusion pump assembly 100, 100', 400, 500.

[0855] In addition, and as described above, one embodiment of electrical control assembly 816 may include three microprocessors. One processor (e.g., which may include, but is not limited to, a CC2510 microcontroller / RF transceiver available from Chipcon AS of Oslo, Norway) may be dedicated to radio communications, such as for communicating with remote control assembly 300. Two additional microprocessors (e.g., supervisor processor 1800 and command processor 1802) may implement the delivery of infusible fluids (as described 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. of Dallas, Texas.

[0856] The OS can be a non-preemptive scheduling system because all tasks are allowed to run to completion before the next task is allowed to run, regardless of priority. In addition, no context switching is performed. When a task completes execution, the highest priority task currently scheduled to run can be executed. If no tasks are scheduled for execution, the OS can place the processor (e.g., supervisor processor 1800 and / or command processor 1802) into a low-power sleep mode and wake it up when the next task is scheduled. The OS can be used only to manage the main loop code and can leave interrupt-based functions unaffected.

[0857] The OS may be written in C++. Inheritance and virtual functions may be key elements of the design, enabling easy creation, scheduling, and management of tasks.

[0858] At the foundation of the OS, the infrastructure can be the ability to keep track of the system time and the ability to control the processor being placed in low power mode (LPM: also known as sleep mode). This functionality, along with the control and configuration of all system clocks, can be encapsulated by the SysClocks class.

[0859] The SysClocks class may include functionality to place a processor (e.g., supervisor processor 1800 and / or command processor 1802) in LPM to reduce power consumption. When in LPM, the slow real-time clock may continue to run, while the fast system clock that runs the CPU core and most peripherals may be disabled.

[0860] Placing the processor in LPM can always be accomplished through the provided SysClocks function. This function can include all the necessary power-down and power-up sequences to ensure consistency in entering or exiting LPM at any time. Waking up from LPM can be initiated by any interrupt based on the slow clock.

[0861] The OS keeps track of three aspects of time: seconds, milliseconds, and the moment of time. Regarding seconds, SysClocks can begin counting seconds after a processor reset. The seconds counter can be based on the slow system clock and therefore increment regardless of whether the processor is in LPM or full power. Consequently, it marks the boundary at which the processor can wake from sleep to execute previously scheduled tasks. If a task is scheduled to run immediately from an interrupt service routine (ISR), the ISR can wake the processor out of LPM and the task can be immediately executed. Regarding milliseconds, in addition to counting seconds since power-on, SysClocks can also count milliseconds when the processor is in full power mode. Because the fast clock stops during LPM, the millisecond counter may not increment. Therefore, whenever a task is scheduled to execute based on milliseconds, the processor cannot enter LPM. Regarding the moment of time, the moment of time can be expressed within SysClocks as the number of seconds since a specific point in time (e.g., the number of seconds since January 1, 2004).

[0862] The SysClocks class provides useful functionality used throughout the Command and Supervisor project code base. Code delays may be required for hardware settling or for actions to complete. SysClocks offers two types of delays: seconds-based or millisecond-based. When using a delay, the processor can simply wait until the desired time has elapsed before continuing with its current code path. During this time, only ISRs can execute. SysClocks provides all the necessary functionality to set or retrieve the current time.

[0863] The word "task" may be associated with a more complex scheduling system; thus within an OS, a task may be represented by and referred to as a managed function. The ManagedFunc class may be an abstract base class that provides all the necessary control members and functionality to manage and schedule a desired function.

[0864] The ManagedFunc base class may have five control members, two dispatch operation member functions, and a pure virtual execute function that may contain management functionality. All ManagedFunc control members may be hidden from derived classes and may only be set directly by the derived class during creation, thereby simplifying the use of infusion pump assembly 100, 100', 400, 500 and enhancing the security of infusion pump assembly 100, 100', 400, 500.

[0865] Function IDs can be set at creation time and never change. All function IDs can be defined within a single .h file, and the base ManagedFunc constructor can enforce that the same ID is not used for more than one managed function. The ID can also define the priority of a function (relative to other functions) based on the assigned function ID, with higher priority functions being assigned lower function IDs. The highest priority task currently scheduled for execution can be executed before lower priority tasks.

[0866] All other control members can be used to represent the current scheduling state of a function, when it should be executed, and if (at execution time) the function should be rescheduled to execute in a previously set amount of time. Manipulation of these controls and states can be implemented only through public member functions (thus strengthening security controls for all settings).

[0867] To control the scheduling of management functions, the set start and set repeat functions can be used. Each of these member functions can be a simple interface with the ability to configure or disable the repeat setting, as well as control whether the management function is inactive, and whether the management function is scheduled by seconds, milliseconds, or the hour.

[0868] Through inheritance, creating a Managed Function is accomplished by creating a derived class and defining a pure virtual 'execute' function that contains the code that needs to be under the control of the scheduler. The ManagedFunc base class constructor can be based on the function's unique ID, but can also be used to set default control values ​​for use at startup.

[0869] For example, to create a function that runs thirty seconds after startup and every 15 seconds thereafter, you can place the desired code in a dummy execute function and provide the constructor with a function ID scheduled by the seconds state, a thirty-second startup time, and a fifteen-second repetition setting.

[0870] Below is an illustrative code example related to the creation of a management function. In this particular example, a "heartbeat" function is created that is scheduled to execute for the first time one second after startup of infusion pump assembly 100, 100', 400, 500 and every ten seconds thereafter:

[0871]

[0872]

[0873] The actual execution of the management functions can be controlled and executed through the SleepManager class. The SleepManager can contain the actual prioritized list of management functions. This prioritized list of functions can be automatically constructed by the management function creation process, and can ensure that each function is properly created and has a unique ID.

[0874] The primary purpose of the SleepManager class is to have its "management" function called repeatedly by the processor's main loop and / or an infinite while loop. Each time the management function is called, the SleepManager executes all scheduled functions until it has exhausted all scheduled functions; at that point, the SleepManager places the processor in LPM. Once the processor wakes from LPM, it reenters the management function until the processor is ready to enter LPM again (this process repeats until, for example, it is stopped by the user or the system).

[0875] If the processor needs to remain in full power mode for an extended period of time (e.g., when sampling an analog-to-digital conversion), the SleepManager can provide the ability to disable entry into LPM. When LPM is disabled, the management function can continue to search for scheduled tasks.

[0876] The SleepManager also provides an interface for managing the scheduling and recurrence settings of any managed function using the function's unique ID, which enables any part of the code to perform any required scheduling without direct access to or unnecessary knowledge of the desired ManagedFunc object.

[0877] The radio circuitry included within each of infusion pump assembly 100, 100', 400, 500 and remote control assembly 300 may enable wireless communication between remote control assembly 300 and infusion pump assembly 100, 100', 400, 500. A 2.4 GHz radio communication chip (e.g., a Texas Instruments CC2510 radio transceiver) with an internal 8051 microcontroller may be used for radio communication.

[0878] Radio links can balance three objectives: link availability; latency; and energy.

[0879] Regarding 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 the graphical user interface (GUI) of remote control assembly 300. Regarding latency, the communication system may be designed to provide low latency for transmitting data from remote control assembly 300 to infusion pump assembly 100, 100', 400, 500 (and vice versa). Regarding energy, both remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 may have a maximum energy expenditure for radio communications.

[0880] The radio link can support half-duplex communication. Remote control assembly 300 can be the master of the radio link, initiating all communications. Infusion pump assembly 100, 100', 400, 500 can only respond to communications and never initiate communications. Use of this radio communication system can provide various benefits, such as: increased safety; simplified design (e.g., for aircraft use); and coordinated control of the radio link.

[0881] In addition, refer to Figure 120A , shows an illustrative example of the various software layers of the above-described radio communication system.

[0882] The radio processor included in remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 may transfer message 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 assembly 100, 100', 400, 500, radio processor (PRP) 1818 (see Figures 115-116 ) can serve two additional nodes upstream (i.e., command processor 1800 and supervisor processor 1802) via the SPI port. In some embodiments, on remote control assembly 300, radio processor (CRP) can serve at least one additional node upstream or downstream via the SPI port. In some embodiments, the additional node is, for example, the aforementioned remote control processor (UI) and continuous glucose engine (CGE).

[0883] The messaging system enables the communication of messages between various nodes in the network. The UI processor of remote control assembly 300 and, for example, supervisor processor 1800, can use the messaging system to configure and initiate certain mode transitions for the radios of both systems. The radios can also use the messaging system to transmit radio and link status information to other nodes in the network.

[0884] The radio of remote control assembly 300 may use system messages 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 validating the newly updated list may use flags in the heartbeat messages to remove timing uncertainties.

[0885] The radio communication system can be written in C++ for compatibility with messaging software. Each radio node can be addressed using a four-byte radio serial number. A hash table can be used to provide a one-to-one translation between a device's "readable" serial number string and a radio serial number. The hash table can provide a more randomized 8-bit logical address, making it more likely that a pump (e.g., infusion pump assembly 100, 100', 400, 500) or a controller with a similar readable serial number will have a unique logical address. Because the pump (e.g., infusion pump assembly 100, 100', 400, 500) and controller each have a unique role in the radio protocol, the radio serial number does not need to be unique between the pump (e.g., infusion pump assembly 100, 100', 400, 500) and the controller.

[0886] 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 all radio packets except for the RF pairing request message, which may include only the radio serial number of remote control assembly 300, thereby ensuring that it only occurs to the remote control assembly / infusion pump assembly with which it is paired. CC2510 may support a one-byte logical node address, and it may be advantageous to use the one-byte radio serial number as the logical node address to provide a level of filtering for incoming packets.

[0887] The UI processor of remote control assembly 300 may use the Quiet_Radio signal to protect the board of remote control assembly 300 from noise interference from other systems on the board. When Quiet_Radio is asserted, the radio application of remote control assembly 300 may send a message to the radio of infusion pump assembly 100, 100', 400, 500 to assert RadioQuiet mode for a predetermined period of time. Based on noise interference levels measured on the PC board of remote control assembly 300, the Quiet_Radio feature may not be required. During this period, the radio of remote control assembly 300 may remain in Sleep Mode 2 for up to 100 ms. When the Quiet_Radio signal is de-asserted or the maximum period has expired, the radio of remote control assembly 300 may exit Sleep Mode 2. The UI processor of remote control assembly 300 may assert Quiet_Radio for at least one radio communication interval before an assertion event is required. The radio of remote control assembly 300 may inform the radio of infusion pump assembly 100, 100', 400, 500 that communications will be shut down during this quiet period. The periodic radio link protocol may have a status bit / byte to accommodate the Quiet_Radio feature unless Quiet_Radio is not desired.

[0888] The radio software can be integrated with the messaging system and radio bootloader on the same processor and can be verified using throughput testing. The radio software can be integrated with the messaging system, SPI driver using DMA, and radio bootloader all on the same processor (e.g., TI CC2510).

[0889] The radio of remote control assembly 300 may be configured to consume no more than 32 mAh over three days (assuming one hundred minutes of rapid heartbeat mode communications per day). The radio of infusion pump assembly 100, 100', 400, 500 may be configured to consume no more than 25 mAh over three days (assuming one hundred minutes of rapid heartbeat mode communications per day).

[0890] The maximum time to reacquire communication may be ≤ 6.1 seconds, including both connection request mode and acquisition mode. The radio of remote control assembly 300 may use either the fast heartbeat mode or slow heartbeat mode setting, as appropriate, to conserve power and minimize user latency. The difference between infusion pump assembly 100, 100', 400, 500 entering acquisition mode and remote control assembly 300 may be that infusion pump assembly 100, 100', 400, 500 needs to enter acquisition mode frequently enough to ensure that communication can be restored within the maximum latency period. However, when in slow heartbeat mode and a heartbeat is lost, remote control assembly 300 may vary the frequency with which infusion pump assembly 100, 100', 400, 500 enters acquisition mode. The radio of remote control assembly 300 may have knowledge of user GUI interactions, while infusion pump assembly 100, 100', 400, 500 may not.

[0891] The radio of remote control assembly 300 can set a heartbeat period for both radios. This period can be selected based on activity to optimize power and link latency. The desired heartbeat period can be transmitted from the radio of remote control assembly 300 to the radio of infusion pump assembly 100, 100', 400, 500 in each heartbeat. This does not exclusively establish the heartbeat rate of infusion pump assembly 100, 100', 400, 500 due to other factors that determine which mode is in. When in fast heartbeat mode, if data packets are available for transmission or reception, the radio of remote control assembly 300 can set the heartbeat period to 20 ms, thereby providing low link latency communication when actively exchanging data.

[0892] When in fast heartbeat mode, the radio of remote control assembly 300 may set the heartbeat period to four heartbeats of 60ms after the last data packet exchanged in either direction on the radio. Keeping the radio heartbeat period short after a data packet has been sent or received ensures that any data response packets can also be serviced with 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.

[0893] Infusion pump assembly 100, 100', 400, 500 may use the heart 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:

[0894] Pairing mode

[0895] Connection mode

[0896] • Acquisition mode (including the desired paired infusion pump assembly 100, 100', 400, 500)

[0897] ● Radio serial number)

[0898] ●Synchronous mode - fast heartbeat

[0899] ●Synchronous Mode - Slow Heartbeat

[0900] RF off mode

[0901] The radio of infusion pump assembly 100, 100', 400, 500 may support the following mode requests via the messaging system:

[0902] Pairing mode

[0903] ●Acquisition mode

[0904] RF off mode

[0905] The radio may use system messages to obtain the local radio serial number. On remote control assembly 300, the radio may get the serial number from the UI processor of remote control assembly 300. The radio may use system messages to store paired radio serial numbers.

[0906] Remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 may use the messaging system to publish status messages to the UI processor and command processor 1802 of remote control assembly 300 when the following status changes:

[0907] ●Online fast: Successfully connected

[0908] ● Online fast: Change from acquisition mode to fast heartbeat mode

[0909] ● Online Slow: Successfully requested a change from fast heartbeat to slow heartbeat

[0910] ●Offline: Automatically changes to search synchronization mode due to no heartbeat exchange

[0911] ● Online Fast: Successfully requested a change from slow heartbeat to fast heartbeat

[0912] ● Offline: Bandwidth drops below 10% in synchronous mode

[0913] ●Online: Bandwidth increased to more than 10% in search synchronization mode

[0914] ●Offline: Successfully requested to change to RF off mode

[0915] The radio configuration message can be used to configure the number of radio retries. This message may be sent via the messaging system. The UI processor of remote control assembly 300 will send this command to the radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 to configure these radio settings.

[0916] There may be two parameters in the radio configuration information: the number of RF retries (eg, the value may be from 0 to 10); and the radio offline parameter (eg, the value may be from 1% to 100% of the bandwidth).

[0917] The radio applications on remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 may have an API that allows the messaging system to configure the number of RF retries and radio offline parameters.

[0918] The following parameters are recommended for radio hardware configuration:

[0919] ●Basic radio specifications

[0920] MSK

[0921] ●250kbps air baud rate

[0922] ●Up to 84 channels

[0923] ●Channel spacing 1000kHz

[0924] ●Filter bandwidth 812kHz

[0925] Non-Manchester code

[0926] Data whitening

[0927] ●4-byte preamble

[0928] ●4-byte synchronization (word)

[0929] ●CRC is attached to the packet

[0930] LQI (Link Quality Indicator) attached to the packet

[0931] ●Enable automatic CRC filtering

[0932] Forward Error Correction (FEC) may or may not be used.While Forward Error Correction (FEC) can be used to increase the effective signal dynamic range by approximately 3dB, FEC requires a fixed packet size and doubles the number of air bits for the same fixed size message.

[0933] Under nominal operating conditions (except in pairing mode), the radio can function at a distance of 1.83 meters. A goal may be for the radio to function at a distance of 7.32 meters under nominal operating conditions. The transmit power level may be 0 dBm (except in pairing mode), where it may be -22 dBm. Because the desired radio node address of infusion pump assembly 100, 100', 400, 500 may not be known to remote control assembly 300 in pairing mode, both infusion pump assembly 100, 100', 400, 500 and remote control assembly 300 may use low transmit power to reduce the likelihood of accidentally pairing with another infusion pump assembly.

[0934] AES encryption can be used for all packets, but this may not be required because the Texas Instruments CC2510 radio transceiver includes this functionality. If AES encryption is used, a fixed key can be used because it provides a quick way to enable encryption without passing the key. However, key changes may be provided in future versions of infusion pump assembly 100, 100', 400, 500. The fixed key can be contained in a separate header file containing only the fixed key data and no other variables, making it easier to manage read access to the file.

[0935] The radio software supports the following eight modes:

[0936] Pairing mode

[0937] RF off mode

[0938] Connection mode

[0939] ●Acquisition mode

[0940] Fast heartbeat mode

[0941] Slow heartbeat mode

[0942] Search Sync Mode

[0943] Synchronous acquisition mode

[0944] This is Figures 120B-120C As shown in the diagram.

[0945] Pairing may be the process of exchanging radio serial numbers between remote control assembly 300 and infusion pump assembly 100, 100', 400, 500. When infusion pump assembly 100, 100', 400, 500 knows its serial number, remote control assembly 300 may "pair" with infusion pump assembly 100, 100', 400, 500. When remote control assembly 300 knows its serial number, infusion pump assembly 100, 100', 400, 500 may "pair" with remote control assembly 300.

[0946] Pairing mode (which is Figure 120D ) may require exchanging four pieces of information over the RF link:

[0947] RF pairing request (broadcast from remote control assembly 300 to any infusion pump assembly 100, 100', 400, 500)

[0948] RF pairing acknowledge (from infusion pump assembly 100, 100', 400, 500 to remote control assembly 300)

[0949] RF pairing confirmation request (from remote control assembly 300 to infusion pump assembly 100, 100', 400, 500)

[0950] RF pairing confirmation acknowledgement (from infusion pump assembly 100, 100', 400, 500 to remote control assembly 300)

[0951] Additionally, remote control assembly 300 may cancel 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). Pairing mode may not support messaging system data transfer.

[0952] The radio of infusion pump assembly 100, 100', 400, 500 may enter pairing mode upon receiving a pairing mode request message. If no disposable is attached to infusion pump assembly 100, 100', 400, 500 and the user has pressed the button of infusion pump assembly 100, 100', 400, 500 for 6 seconds, it may be the responsibility of supervisor processor 1800 on infusion pump assembly 100, 100', 400, 500 to request that the radio enter pairing mode. 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.

[0953] While in pairing mode, upon receiving the first valid RF pairing request message, the radio of infusion pump assembly 100, 100', 400, 500 may use the serial number of remote control assembly 300 for the duration of pairing mode and may respond with an RF pairing acknowledge message that includes the serial number of the radio of infusion pump assembly 100, 100', 400, 500.

[0954] If an RF pairing request is not received, the radio of infusion pump assembly 100, 100', 400, 500 may automatically time out of pairing mode after 2.0 ± 0.2 seconds. After transmitting an RF pairing acknowledgement, the radio of infusion pump assembly 100, 100', 400, 500 may issue a Pairing Request Received message. This message to the administrator processor allows for feedback to the user during the pairing confirmation process. After transmitting an RF pairing acknowledgement, if an RF pairing confirmation request is not received, the radio of infusion pump assembly 100, 100', 400, 500 may automatically time out of pairing mode within 1.0 ± 0.1 minutes. If an RF pairing confirmation request message is received after receiving an RF pairing request message, the radio of infusion pump assembly 100, 100', 400, 500 may issue a Store Paired Radio Serial Number message. This action may store the radio serial number of remote control assembly 300 in the non-volatile memory of infusion pump assembly 100 , 100 ′, 400 , 500 and may overwrite the existing pairing data for infusion pump assembly 100 , 100 ′, 400 , 500 .

[0955] Upon receipt of the store paired radio serial number message, the radio of infusion pump assembly 100, 100', 400, 500 may transmit an RF pairing confirmation acknowledgement and exit pairing mode following the acknowledgement. This may be a normal exit from pairing mode on infusion pump assembly 100, 100', 400, 500 and may cause infusion pump assembly 100, 100', 400, 500 to power down before the user enters connect mode or pairing mode.

[0956] If the radio of infusion pump assembly 100, 100', 400, 500 exits pairing mode after successfully receiving the pairing confirmation request message, the radio of infusion pump assembly 100, 100', 400, 500 may revert to the newly paired remote control assembly 300 and may send a pairing complete success message to command processor 1802. The radio of infusion pump assembly 100, 100', 400, 500 may exit pairing mode after receiving an RF pairing abort message. The radio of infusion pump assembly 100, 100', 400, 500 may exit pairing mode after receiving a pairing abort request message addressed to it. This enables command processor 1802 or supervisor processor 1800 to locally abort the pairing process on infusion pump assembly 100, 100', 400, 500.

[0957] The radio of remote control assembly 300 may enter pairing mode after receiving the pairing mode request message. The UI processor of remote control assembly 300 may be responsible for requesting that the radio enter pairing mode under appropriate conditions. The radio of remote control assembly 300 may set an appropriate transmit power level for pairing mode. The radio of remote control assembly 300 may transmit RF pairing requests until an RF pairing acknowledgement is received or pairing is aborted.

[0958] After entering pairing mode, the radio of remote control assembly 300 may automatically terminate pairing mode if an RF pairing acknowledgement message is not received within 30.0±1.0 seconds. While in pairing mode, upon receiving the first valid RF pairing acknowledgement message, the radio of remote control assembly 300 may send a pairing success message including the serial number of infusion pump assembly 100, 100', 400, 500 to the UI processor of remote control assembly 300, and may use that serial number for the duration of pairing mode. This message may provide the UI processor of remote control assembly 300 with a method for 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 (to a single pairing request) from infusion pump assembly 100, 100', 400, 500, the first valid response may be used.

[0959] When in pairing mode, after receiving an RF pairing acknowledgement, the radio of remote control assembly 300 may only accept an RF pairing confirmation acknowledgement message. The radio of remote control assembly 300 may transmit an RF pairing confirmation message after receiving a pairing confirmation request message from the UI processor of remote control assembly 300.

[0960] Before adding infusion pump assembly 100, 100', 400, 500 to the pairing list, the radio of remote control assembly 300 may verify that infusion pump assembly 100, 100', 400, 500 has confirmed the pairing. If an RF pairing complete message is received, the radio of remote control assembly 300 may announce that the paired radio serial number information is stored. This action may allow 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 that the pairing was successful. The UI processor of remote control assembly 300 may be responsible for managing the list of paired infusion pump assemblies.

[0961] The radio of remote control assembly 300 may send an RF pairing abort message and exit pairing mode after receiving the pairing abort request message. This enables the UI processor of remote control assembly 300 to abort the pairing process on remote control assembly 300 and the responding infusion pump assembly 100, 100', 400, 500.

[0962] In connection request mode, the radio of remote control assembly 300 may attempt to acquire each infusion pump assembly 100, 100', 400, 500 in its list of paired infusion pump assemblies and retrieve its "connection ready" status. Figure 120E ) enables remote control assembly 300 to quickly identify a ready-to-use infusion pump assembly among its paired infusion pump assemblies. The radio of remote control assembly 300 is capable of executing a connection request mode with up to six paired infusion pump assemblies. Connection request mode may be supported only on remote control assembly 300 and may be a specialized form of acquisition mode. In connection request mode, remote control assembly 300 may connect to the first infusion pump assembly to respond. However, each message may be directed to a specific infusion pump assembly serial number.

[0963] After entering connection mode, the radio of remote control assembly 300 may obtain a list of the most recently paired infusion pump assembly serial numbers. The radio of remote control assembly 300 may enter connection mode upon receiving a connection mode request message. When remote control assembly 300 desires to communicate with a paired infusion pump assembly, the UI processor of remote control assembly 300 may be responsible for requesting the radio to enter connection mode. The radio of remote control assembly 300 may issue a connection assessment message to the UI processor of remote control assembly 300, including the serial number of the radio of the first infusion pump assembly that is "ready to connect," if any. The radio of remote control assembly 300 may generate connection assessment messages within thirty seconds of entering connection request mode. Upon receiving a positive connection assessment acknowledgment, the radio of remote control assembly 300 may exit connection request mode and transition to fast heartbeat mode. The radio of remote control assembly 300 may exit connection request mode upon receiving a connection request abort message from the UI processor of remote control assembly 300.

[0964] On remote control assembly 300, acquisition mode can be used to find a specific paired infusion pump assembly. The radio of remote control assembly 300 may send an RF RUT (Are You There?) packet to the desired paired infusion pump assembly. If the infusion pump assembly receives the RF RUT message, it may respond to the radio of remote control assembly 300. Multiple channels may be used in the acquisition mode algorithm to improve the chances of the radio of remote control assembly 300 finding a paired infusion pump assembly.

[0965] When in RF off mode, the radio of remote control assembly 300 may enter acquisition mode upon receiving an acquisition mode request or a fast heartbeat mode request message. When in search sync mode, the radio of remote control assembly 300 may enter synchronized acquisition mode upon receiving an acquisition mode request or a fast heartbeat mode request message. When the RF link is offline and remote control assembly 300 desires to communicate with infusion pump assembly 100, 100', 400, 500, it may be the responsibility of the UI processor of remote control assembly 300 to request that the radio enter acquisition mode.

[0966] The radio of remote control assembly 300 may communicate (except in pairing and connecting modes) with only one paired infusion pump assembly 100, 100', 400, 500. When 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.

[0967] Infusion pump assembly 100, 100', 400, 500 may enter acquisition mode under the following conditions:

[0968] ●When in radio off mode and acquisition mode can be requested

[0969] ●When search sync mode times out due to lack of heartbeat

[0970] After 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 communicate only with the remote control assembly with which it has been "paired" (except when in "pairing request" mode). The radio of infusion pump assembly 100, 100', 400, 500 may transition from acquisition mode to fast heartbeat mode after successfully acquiring synchronization with remote control assembly 300. The acquisition mode of infusion pump assembly 100, 100', 400, 500 is capable of acquiring synchronization in 6.1 seconds, which may mean that when in acquisition mode, infusion pump assembly 100, 100', 400, 500 may always be listening at least every ~6 seconds.

[0971] When two paired devices are in sync mode and online, data packets may be sent between the two paired devices. Prior to exchanging data packets, the two devices may synchronize via heartbeat packets. After the heartbeat exchange, each radio may send data packets at known intervals. Infusion pump assembly 100, 100', 400, 500 may adjust its timing to anticipate the receipt of packets. For each heartbeat, the radio may support one data packet in each direction. If the radio is offline, the radio may provide a negative response to a fast heartbeat mode request. When in slow heartbeat mode and the radio is online, the radio of remote control assembly 300 may change to fast heartbeat mode if a system request for fast heartbeat mode is received.

[0972] After transitioning from acquisition mode to fast heartbeat mode, the radio of remote control assembly 300 may send a master channel list message. The master channel list may be created by the radio of remote control assembly 300 and sent to the radio of infusion pump assembly 100, 100', 400, 500 to enable selection of frequency hopping channels based on historical performance. When in fast or slow heartbeat mode, periodic heartbeat messages may be exchanged between the radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500. The period of these messages may follow the heartbeat rate. Heartbeat messages may allow data packet transfers to occur and may also exchange status information. The two radios may exchange the following status information: quiet mode, data availability, buffer availability, heartbeat rate, and previous channel performance. A goal may be to keep the packet size of heartbeat messages small to conserve energy. When in synchronous mode, the radio may provide a maximum data packet size of 82 bytes. The messaging system can be designed to support packet payload sizes of up to sixty-four bytes. This maximum size was chosen as the best trade-off between the smallest message types and non-fragmented messages. Eighty-two bytes may be the maximum packet size for the messaging system, including packet overhead.

[0973] The messaging system may have an API that allows the radio protocol to send incoming radio packets to it. The messaging system may also have an API that allows the radio protocol to obtain packets for transmission via the radio network. The messaging system may be responsible for packet routing between the radio protocol and the SPI port. Data packets may be provided to the messaging system for processing. The messaging system may have an API that allows the radio protocol to obtain a count of the number of data packets waiting to be sent via the radio network. The radio protocol may query the messaging system for each heartbeat to determine whether a data packet is available for transmission via the radio network. It is desirable for software to check for message availability just before sending a heartbeat to minimize round-trip message latency.

[0974] The radio protocol can buffer an incoming radio data packet and pass it to the messaging system. The radio protocol can send a data packet to the messaging system after receiving it. The messaging system can be responsible for routing the radio data packet to the appropriate destination node. The radio protocol can buffer a packet from the messaging system.

[0975] The radio protocol may be responsible for acknowledging receipt of valid data packets over the RF link via an RF ACK reply packet to the sending radio. The RF ACK packet may contain source and destination radio serial numbers, an RF ACK command identification, and the sequence number of the data packet being acknowledged.

[0976] If no RF ACK is received and the retry count is within the maximum allowed RF retries, the radio device that transmitted the radio data packet may retransmit the radio data packet with the same sequence number on the next heartbeat. It is expected that interference will occasionally disrupt transmissions on a particular frequency. RF retries allow the same packet to be retransmitted on a different frequency at the next opportunity. The sequence number provides a way to uniquely identify the packet over a short time window. The number of radio packet retries can be configured using radio configuration commands. Allowing more retries increases the probability of packet exchange, but introduces more latency for round-trip messages. The default number of retries for a radio device at power-up may be ten (i.e., the maximum transmission effort before the message is discarded).

[0977] A one-byte (modulo 256) radio sequence number may be included in all radio data packets transmitted over the RF link. Since the radio is responsible for retrying data packet transmissions if they are not acknowledged, the sequence number provides a way for both radios to know if data packets are duplicates. The transmitted sequence number may be incremented for each new radio data packet, and may allow for rollover of transmitted sequence numbers. When a data packet is successfully received with the same sequence number as a previously successfully received data packet (and in the same direction), the data packet may be ACKed and the received data packet discarded. This eliminates duplicate packets generated by the RF protocol before they are introduced into the network. Note that in extreme cases, it may be necessary to discard multiple consecutive data packets with the same sequence number.

[0978] If a heartbeat is missed, the radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 may attempt to transmit and listen, respectively, for subsequent heartbeats. If a heartbeat is missed for two seconds, the radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 may automatically change from fast heartbeat mode or slow heartbeat mode to search for sync mode. Since two seconds provides enough time to skip all channels, power consumption can be minimized when a link is lost by allowing the radios to continue using their synchronization information.

[0979] A radio is considered online when it is in the following modes:

[0980] Fast heartbeat mode

[0981] Slow heartbeat mode

[0982] Because these are the only conditions under which system traffic can be exchanged, all other conditions can be considered offline.

[0983] When code execution begins from reset, the radio may be initialized to radio-off mode. When code is first executed on the radio processor, the initial state may be radio-off mode to allow other processors to perform self-tests before requesting the radio to activate. This requirement is not intended to limit the mode when waking from sleep mode. When set to radio-off mode, the radio may cease RF communications. On remote control assembly 300, this mode may be intended for use in aircraft to suppress RF emissions. Since infusion pump assembly 100, 100', 400, 500 only responds to transmissions from remote control assembly 300 (which has already ceased transmitting in airplane mode), radio-off mode may be used only on infusion pump assembly 100, 100', 400, 500 when charging.

[0984] Command processor 1802 may be told to be in airplane mode, so the RF is intentionally turned off for remote control assembly 300 so that it does not generate a walk away warning. However, this may be completely hidden from the radio of infusion pump assembly 100, 100', 400, 500.

[0985] The radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 may periodically attempt to exchange heartbeats to reestablish data bandwidth while in search sync mode. If no heartbeats are successfully exchanged after twenty minutes in search sync mode, the radio of remote control assembly 300 may transition to radio off mode.

[0986] If a heartbeat is not successfully exchanged after twenty minutes in search sync mode, the radio of infusion pump assembly 100, 100', 400, 500 may transition to acquisition mode. Listening during pre-agreed time slots may be the most efficient use of the power available to infusion pump assembly 100, 100', 400, 500 to reestablish the RF link. After communication is lost, crystal tolerances and temperature drift may necessitate extending the receive window of infusion pump assembly 100, 100', 400, 500 over time. Remaining in search sync mode for an extended period (e.g., 5-20 minutes) after communication is lost may result in the instantaneous power consumed exceeding the average power budgeted for the radio of infusion pump assembly 100, 100', 400, 500. The radio of remote control assembly 300 may not be forced to extend its window, so remaining in search sync mode may be very power-efficient. Acquisition mode may consume more power for remote control assembly 300. Twenty minutes may be used as a compromise to balance power consumption on both the radio of remote control assembly 300 and the radio of infusion pump assembly 100 , 100 ′, 400 , 500 .

[0987] If the radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 have successfully exchanged three of the last five heartbeats, they may transition to slow heartbeat mode. Approximately every six seconds, a burst of five heartbeats may be attempted. If three of these are successful, the bandwidth may be deemed sufficient to transition to slow heartbeat mode. When in search sync mode, the radio of infusion pump assembly 100, 100', 400, 500 may acquire with a wait time of 6.1 seconds. This may mean that when in search sync mode, infusion pump assembly 100, 100', 400, 500 may always be listening at least every ~6 seconds.

[0988] Radio protocol performance statistics are necessary to facilitate radio device troubleshooting and evaluate radio performance. The following radio performance statistics can be maintained in a data structure by the radio protocol:

[0989]

[0990]

[0991] The #define DEBUG option (compiler option) can be used to collect additional radio performance statistics for each channel as follows (16-bit numbers):

[0992] Number of missed hops

[0993] Good CCA count

[0994] CCA bad count

[0995] Average RSSI (accumulated only for good RX packets)

[0996] ●Count of discards from the hopping list

[0997] ● Acquisition mode count (pairs found on this channel)

[0998] A debug option can be used to collect only engineering statistics. If processor performance, power, and memory allow, it may be desirable to maintain this information at runtime. Radio statistics can be made available to the messaging system.

[0999] Link quality may be designed to provide a bar indicator of radio link quality similar to a cellular telephone on remote control assembly 300. Link quality may be available to both remote control assembly 300 and infusion pump assembly 100, 100', 400, 500. It is contemplated that the link quality status will include a one-byte indicator of the quality of the radio link.

[1000] The radio can change frequency with each heartbeat. An adaptive pseudo-random frequency hopping algorithm can be used for heartbeat attempts in sync mode and search sync mode. The goal is to use sixty-four channels for frequency hopping. A method can be developed to adaptively generate a channel list for frequency hopping on remote control assembly 300. The radio of remote control assembly 300 can build, maintain, and distribute a master channel list. The radio of remote control assembly 300 can obtain previous channel statistics and historical performance information from the radio of infusion pump assembly 100, 100', 400, 500 using a messaging system as needed to meet performance requirements. By building the channel list from the perspective of both units, the radio interference environment of both units can be taken into account. The radio can adaptively select hopping channels to meet round-trip message latency while operating in the desired RF environment.

[1001] Blockages and / or leaks may occur anywhere along the fluid delivery path of infusion pump assembly 100. For example and with reference to Figure 121 , blockages / leaks may occur in: the fluid path between reservoir 118 and reservoir valve assembly 614; in the fluid path between reservoir valve assembly 614 and pump assembly 106; in the fluid path between pump assembly 106 and volume sensor valve assembly 612; in the fluid path between volume sensor valve assembly 612 and volume sensor chamber 620; in the fluid path between volume sensor chamber 620 and measurement valve assembly 610; and in the fluid path between measurement valve assembly 610 and the tip of disposable cannula 138. Infusion pump assembly 100 may be configured to execute one or more blockage / leak detection algorithms that detect and locate these blockages / leaks and enhance the safety / reliability of infusion pump assembly 100.

[1002] As described above, when administering an infusible fluid, infusion pump assembly 100 may first determine the volume of the infusible fluid within volume sensor chamber 620 before administering a dose of the infusible fluid, and then determine the volume of the infusible fluid within volume sensor chamber 620 after administering the dose of the infusible fluid. By monitoring these values, the occurrence of an occlusion / leak may be detected.

[1003] Occlusion Type—Complete: When a complete occlusion occurs, the difference between the initial measurement before administration of the dose of infusible fluid and the final measurement after administration of the dose of infusible fluid will be zero (or substantially zero), indicating a large amount of remaining infusible fluid within volume sensor chamber 620. Therefore, no fluid may be leaving volume sensor chamber 620.

[1004] Specifically, if the tip of the disposable cannula is blocked, the fluid path downstream of volume sensor chamber 620 will fill with fluid and eventually be pressurized to a level equal to the mechanical pressure applied by spring diaphragm 628. Thus, when measurement valve assembly 610 opens, zero (or substantially zero) fluid will be dispensed, and thus, the initial and final measurements (made by volume sensor assembly 148) will be substantially equal.

[1005] Upon detecting the occurrence of such a condition, a full occlusion flag may be set and infusion pump assembly 100 may, for example, trigger an alarm, thereby indicating that the user needs to seek an alternative device to receive their therapy.

[1006] Occlusion Type - Partial: When a partial occlusion occurs, the difference between the initial measurement before administering the dose of the infusible fluid and the final measurement after administering the dose of the infusible fluid will indicate a difference that is less than if a full dose of the infusible fluid had been delivered. For example, assume that at the end of a particular pumping cycle, volume sensor assembly 148 indicates that 0.10 microliters of infusible fluid is present in volume sensor chamber 620. Furthermore, assume that measurement valve assembly 610 is subsequently closed and pump assembly 106 is subsequently actuated, causing volume sensor chamber 620 to fill with infusible fluid. Furthermore, assume that volume sensor assembly 148 determines that volume sensor chamber 620 is now filled with 1.00 microliters of infusible fluid (indicating a pumped volume of 0.90 microliters).

[1007] Thus, upon opening measurement valve assembly 610, the amount of infusible fluid contained within volume sensor chamber 620 would be expected to drop to 0.10 microliters (or reasonably close thereto). However, if a partial obstruction occurs, the amount of infusible fluid within volume sensor chamber 620 may only drop to 0.40 microliters (indicating a delivered volume of 0.60 microliters) due to a slower-than-normal flow rate from volume sensor chamber 620. Thus, by monitoring the difference between the pumped volume (0.90 microliters) and the delivered volume (0.60 microliters), the residual volume can be defined and the occurrence of a partial obstruction can be detected.

[1008] Upon detecting the occurrence of such a condition, a partial occlusion flag may be set and infusion pump assembly 100 may, for example, trigger an alarm, thereby indicating that the user needs to seek an alternative device to receive their therapy. However, because this indicates a partial occlusion (as opposed to a complete occlusion), the issuance of an alarm may be delayed as the partial occlusion may clear on its own.

[1009] Alternatively, infusion pump assembly 100 may: c...

Claims

1. A wearable infusion pump assembly comprising: a fluid reservoir for receiving an infusible fluid; as well as a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set, Wherein, the fluid delivery system comprises: a volume sensor assembly configured to monitor an amount of fluid infused by the wearable infusion pump assembly, Wherein, the volume sensor assembly includes: a volume sensor chamber having a variable volume therein that varies based on an amount of infusible fluid received from the reservoir, a speaker assembly configured to emit sound waves, the speaker assembly being coupled to a fixed volume and generating a time-varying pressure within the fixed volume, a port assembly for coupling the variable volume to the fixed volume, a variable volume microphone for acoustically responding to sound waves emitted by the speaker assembly, and a reference microphone for generating an acoustic response to sound waves emitted by the speaker assembly, The wearable infusion pump assembly further includes at least one processor and a computer-readable medium coupled to the at least one processor, wherein the computer-readable medium stores a plurality of instructions. When the instructions are executed by the at least one processor, the instructions cause the at least one processor to perform the following operations: determining a relative response between an acoustic response produced by the variable volume microphone and an acoustic response produced by the reference microphone, and Sensing of the variable volume is performed based at least on a comparison of acoustic responses of the reference microphone and the variable volume microphone with an input to the speaker assembly.

2. A wearable infusion pump assembly comprising: a fluid reservoir for receiving an infusible fluid; a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set, wherein the fluid delivery system includes a volume sensor assembly configured to receive a volume of the infusible fluid from the reservoir, Wherein, the volume sensor assembly includes: a volume sensor chamber having a variable volume therein that varies based on an amount of infusible fluid received from the reservoir, a speaker assembly configured to emit sound waves, the speaker assembly being coupled to a fixed volume and generating a time-varying pressure within the fixed volume, a port assembly for coupling the variable volume to the fixed volume, a variable volume microphone for acoustically responding to sound waves emitted by the speaker assembly, and a reference microphone for generating an acoustic response to sound waves emitted by the speaker assembly; at least one processor; and A computer-readable medium coupled to the at least one processor, the computer-readable medium having a plurality of instructions stored thereon, which, when executed by the at least one processor, cause the at least one processor to perform the following operations: determining a relative response between an acoustic response produced by the variable volume microphone and an acoustic response produced by the reference microphone, performing sensing of the variable volume based at least on a comparison of acoustic responses of the reference microphone and the variable volume microphone with an input to the speaker assembly, determining a first volume of infusible fluid within a volume sensor chamber of the volume sensor assembly before providing the quantity of infusible fluid to the external infusion set, determining a second volume of infusible fluid within the volume sensor chamber of the volume sensor assembly after providing the quantity of infusible fluid to the external infusion set, and Determine whether a blocking state occurs.

3. A wearable infusion pump assembly comprising: a fluid reservoir for receiving an infusible fluid; a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set, wherein the fluid delivery system includes a volume sensor assembly configured to receive a volume of the infusible fluid from the reservoir; a volume sensor assembly configured to monitor an amount of fluid infused by the wearable infusion pump assembly, Wherein, the volume sensor assembly includes: a volume sensor chamber having a variable volume therein that varies based on an amount of infusible fluid received from the reservoir, a speaker assembly configured to emit sound waves, the speaker assembly being coupled to a fixed volume and generating a time-varying pressure within the fixed volume, a port assembly for coupling the variable volume to the fixed volume, a variable volume microphone for acoustically responding to sound waves emitted by the speaker assembly, and a reference microphone for generating an acoustic response to sound waves emitted by the speaker assembly; at least one processor; and A computer-readable medium coupled to the at least one processor, the computer-readable medium having a plurality of instructions stored thereon, which, when executed by the at least one processor, cause the at least one processor to perform the following operations: determining a relative response between an acoustic response produced by the variable volume microphone and an acoustic response produced by the reference microphone, performing sensing of the variable volume based at least on a comparison of acoustic responses of the reference microphone and the variable volume microphone with an input to the speaker assembly, determining an amount 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 delivery target amount to determine a difference, and Subsequent deliveries of the infusible fluid are adjusted to compensate for the differential amount.

4. A wearable infusion pump assembly comprising: a fluid reservoir for receiving an infusible fluid; an external infusion set configured to deliver the infusible fluid to a user; as well as a fluid delivery system configured to deliver the infusible fluid from the reservoir to the external infusion set, Wherein, the fluid delivery system comprises: Volume sensor assembly; a pump assembly for withdrawing a quantity of infusible fluid from the reservoir and providing the quantity of infusible fluid to the volume sensor assembly, wherein the volume sensor assembly is 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; a second valve assembly configured to selectively isolate the volume sensor assembly from the external infusion set; a volume sensor valve assembly configured to selectively isolate the volume sensor assembly from the pump assembly; and A shape memory actuator is anchored at one end to a shape memory actuator anchor and at another end for providing mechanical energy to a valve assembly configured to activate the second valve assembly.

5. The wearable infusion pump assembly of claim 1 , wherein: The variable volume microphone is a microphone positioned near the variable volume; and The reference microphone is a microphone positioned near the at least one fixed volume.

6. The wearable infusion pump assembly of claim 1 , further comprising: a disposable housing assembly, the disposable housing assembly including the liquid reservoir; a reusable housing assembly, the reusable housing assembly including a mechanical control assembly; The reusable housing assembly is releasably engaged with the disposable housing assembly via a releasable engagement assembly.

7. The wearable infusion pump assembly of claim 6, wherein the pump assembly is configured to draw the amount of the infusible fluid from the reservoir and provide the amount of the infusible fluid to the volume sensor assembly.

8. The wearable infusion pump assembly of claim 7, wherein a first valve assembly is configured to selectively isolate the pump assembly from the reservoir.

9. The wearable infusion pump assembly of claim 8, wherein a second valve assembly is configured to selectively isolate the volume sensor assembly from the external infusion set.

10. The wearable infusion pump assembly of claim 2, wherein the instructions for determining whether an occlusion condition has occurred include instructions for: calculating a difference between the first volume and the second volume; The difference is analyzed to determine if a blocking condition has occurred.

11. The wearable infusion pump assembly of claim 3, wherein the differential amount indicates overdelivery and subsequent deliveries of the infusible fluid are reduced.

12. The wearable infusion pump assembly of claim 3, wherein the differential amount indicates an underdelivery and a subsequent delivery amount of the infusible fluid is increased.

13. The wearable infusion pump assembly of claim 3, wherein: The variable volume microphone is a microphone positioned near the variable volume; and The reference microphone is a microphone positioned near the at least one fixed volume.

14. The wearable infusion pump assembly of claim 4, in, The wearable infusion pump assembly further includes a cradle assembly that automatically locks the second valve assembly in an activated position once the second valve assembly is activated.

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