WO2010078434A2

WO2010078434A2 - Apparatus, system and method for fluid delivery

Info

Publication number: WO2010078434A2
Application number: PCT/US2009/069830
Authority: WO
Inventors: Richard J. Lanigan; Bright Chong Khuang Foo; Dean Kamen
Original assignee: Deka Products Limited Partnership
Priority date: 2008-12-31
Filing date: 2009-12-30
Publication date: 2010-07-08
Also published as: WO2010078434A3; WO2010078207A1

Abstract

A fill adapter system (2700) for an infusion pump assembly. The system includes a reusable fill adapter base, the base including a volume control mechanism (2702) to adjust an available fill volume of a reservoir of the infusion pump assembly and a pomp mechanism (2718) configured to pump air into a fluid vial. The system also includes a vial adapter assembly including a first needle configured to penetrate a septum of the fluid vial for fluidly coupling the pump mechanism to the fluid vial and a second needle having a first end configured to penetrate the septum of the fluid vial and a second end configured to penetrate a septum of the reservoir of the infusion pump assembly to allow transfer of fluid from the fluid vial to the reservoir of the infusion pump assembly in response to air being pumped into the fluid vial and a needle carriage adapted to carry the first needle and the second needle, wherein the needle carriage slidably attached to the interior of the vial adapter assembly, wherein the needle carriage adapted to slide from a vial end of the vial adapter to a receptacle end of the vial adapter.

Description

APPARATUS, SYSTEM ANB METHOD FOR FLUID BELlVERY

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Non-Provisional Patent Application which claims priority from the following Li. S. Provisional Patent Applications both of which are hereby incorporated herein by reference in its entirety:

U.S. Provisional Patent Application Serial No. 61/142,042, filed December 3 L 2008 and entitled Method, System and Apparatus for Verification of Volume and Pumping (Attorney Docket No. G78): and U.S. Provisional Patent Application Serial No, 61/225,794, filed July 15, 2009 and entitled Infusion Pump Assembly (Attorney Docket No. ! !48).

FIELD OF THE INVENTION

This application relates generally to fluid delivery systems, and more particularly to apparatus, system and method lor fluid delivery.

BACKGROUND OF THE INVENTION

Many potentially valuable medicines or compounds, including biologicals, are not orally active due io poor absorption, hepatic metabolism or other pharmacokinetic factors. Additionally, some therapeutic compounds, although they can be orally absorbed, are sometimes required to be administered so often it is difficult lor a patient to maintain the desired schedule. In these cases, parenteral deliver)' is often employed or could be employed. Effective parenteral routes of drug delivery, as well as other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous CIV) administration include puncture of the skin with a needle or stylet, insulin Ls an example of a therapeutic fluid that is self-injected by millions of diabetic patients. Users of parenteral!}-¹ delivered drugs may benefit from a wearable device that would automatically deliver needed drugs/compounds over a period of time, To this end, there have been efforts io design portable and wearable devices for the controlled release of therapeutics. Such devices are known to have a reservoir such as a cartridge, syringe, or bag, and to be electronically controlled, These devices suffer from a number of drawbacks including ihe malfunction rate. Reducing the ske, weight and cost of these devices is also an ongoing challenge. Additionally, these devices often apply to the skin and pose the challenge of frequent re-location for application.

SUMMARY OF THE INVENTION

hi accordance with one aspect of ihe present invention a HtI adapter system for an infusion pump assembly is disclosed. The system includes a reusable fill adapter base, the base including a volume control mechanism to adjust an available fill volume of a reservoir of the infusion pump assembly and a pump mechanism configured to pump air into a Fluid vial. The system aiso includes a vial adapter assembly including a first needle configured to penetrate a septum of the fluid via! for flu id Iy coupling the pump mechanism to the fluid vial and a second needle having a first end configured to penetrate the septum of the fluid vial and a second end configured to penetrate a septum of the reservoir of the infusion, pump assembly to allow transfer of fluid from the fluid vial to the reservoir of the infusion pump assembly in response io air being pumped into the fluid vial and a needle carriage adapted to carry the first ncaάk and the second needle, wherein the needle carriage slidably attached to the interior of the vial adapter assembly, wherein the needle carriage adapted io slide from a via! end of the vial adapter to a receptacle end of the via! adapter.

Some embodiments of this aspect of the invention include one or more of the following. Wherein the vial adapter assembly further includes a hydrophobic HSter within a fluid path of the first needle. Wherein the volume control mechanism further includes a (urn dial and a push plate, wherein Ihe turn dial actuates the push plate and wherein the push plate adjusts the available fill volume of a reservoir of the infusion pump assembly. Wherein the filling system further includes a weight scale, the weight scale determining the weight of the infusion pump assembly before Oiling a volume a iluid and the weight scale determining the weight of the infusion pump assembly after the reservoir is Silled to a volume. in accordance with otie aspect of the present invention a filling system for an infusion pump assembly is disclosed. The system includes a volume control mechanism configured to adjust an available fill volume of a reservoir of the infusion pump assembly, a pump mechanism configured to pump air into a fluid via! via a first needle, the first needle configured to penetrate a septum of the fluid vial for fluid Iy coupling the pump mechanism to the fluid vial, and a second needle having a first end configured to penetrate the septum of the fluid vial and a second end configured to penetrate a septum of the reservoir of the infusion pump assembly to allow transfer of fluid from the fluid via! to the reservoir of the infusion pump assembly in response to air being pumped into the iluid vial Some embodiments of this aspect of the invention include one or more of the

IbI Sowing.

Wherein the volume control mechanism further includes a turn dial and a push plate, wherein the turn dial actuates the push plate and wherein the push plate adjusts the available fill volume of a reservoir of the infusion pump assembly in accordance with, one aspect of the present invention a via! adapter. The vial adapter includes a housing having a vial end and a receptacle end and interior wall features, a needle carriage slidabiy attached to the interior of the housing, and a disc slidabiy attached to the interior of the housing, the disc having a first position on the receptacle end of the housing and a second position on the vial end of the housing and configured to raatably attach to the needle carriagcwherein the needle carriage matabiy attaches to the disc and the needle carriage and disc slide Io the via! end of the housing and wherein the disc is locked into a position on the vial end by interior wall features of the housing.

Some embodiments of this aspect of the invention include one or more of the following. Wherein the vial adapter further includes at least one locking feature, the locking feature adapted to mate with at least one key feature on a fill adapter base.

The details of one or more embodiments are set forth in the accompanying drawings and ihe description below. Other features and advantages will become apparent from the description, the drawings, and the claims.

BRI EF I)ESCRlPTf ON OF THE I)RA WINGS

FIG, 1 is a side view of an infusion pump assembly;

FiG. 2 is a perspective view of the infusion pump assembly of FlG, 1 ; FlG, 3 is an exploded view of various components of the infusion pump assembly of FIG. I ;

FlG. 4 is a cross-sectional view of the disposable housing assembly of the infusion pump assembly of FIG. I; FIGS. 5A-5C are cross-sectional views of an embodiment of a septum access assembly;

FKJS. 6A-6B are cross-sectional views of another embodiment of a septum access assembly;

FIGS. 7A-7B are partial top views of another embodiment of a septum access assembly;

HGS. 8A-8B are cross-sectional views of another embodiment of a septum access assembly;

FIG. 9 is a perspective view of the infusion pump assembly of FfG. i showing an external infusion set; RGS. 1 OA- 1 OE depict a plurality of hoofc-and-loop fastener configurations;

FIG. I ! A is an isometric view of a remote control assembly and an alternative embodiment of the infusion pump assembly of FIG. 1;

FIGS. H B-I lR depicts various views of high level schematics and flow charts of the infusion pomp assembly of FIG. I : FiGS. 12A- ! 2F is a plurality of display screens rendered by the remote control assembly of FlG. 1 1 /V,

FiG. 13 is an isometric view of an alternative embodiment of the infusion pump assembly of FlG. I;

FIG. 14 is an isometric view of the infusion pump assembly of RG. 13; FIG. 15 is an isometric view of the infusion pump assembly of FlG. 13;

F!G. 16 is an isometric view of an alternative embodiment of the infusion pump assembly of FIG. i;

FlG. 17 is an plan view of the infusion pump assembly of FfG. 16;

FIG. IS is a plan view of the infusion pump assembly of FSG. 16; FfG. 19 A is an exploded view of various components of the infusion pump assembly of FIG. 16:

FlG. I9B is an isometric view of a portion of the infusion pump assembly of FIG. 16; FlG, 20 is a cross-sectional view of the disposable housing assembly of the infusion pump assembly of FlG. 16;

FlG. 21 is a diagrammatic view of a fluid path within the infusion pump assembly of FICi. 16: FIGS. 22A-22C are diagrammatic views of a fluid paih within the infusion pump assembly of RG. 16;

FlG, 23 is an exploded view of various components of the infusion pump assembly of FIG. 16:

FlG. 24 is a cutaway isometric view of a pump assembly of the infusion pump assembly of FJG. 16;

FIGS. 25A-25D are other isometric views of the pump assembly of FIG. 24;

FlG. 26A-26B are isometric views of a measurement valve assembly of the infusion pump assembly of FI(I 16;

FfG. 27A-27B are side views of the measurement valve assembly of FIGS. 26A- 26B;

FIGS. 28A-28D are views of a measurement valve assembly of the infusion pump assembly of FlG. 16;

FIG. 29 is an isometric view of an alternative embodiment of the infusion pump assembly of FIG. 1; FiG. 30 is an isometric view of an alternative embodiment of the infusion pump assembly of FlG. 1 ;

FIG. 31 is another view of the alternative embodiment infusion pump assembly of FIG. 9;

FIG. 32 is an exploded view of another embodiment of an infusion pump assembly; FIG. 33 is another exploded view of the infusion pump assembly of FlG. 32;

FIGS. 34A-34B depict another embodiment of an infusion pump assembly;

FIGS. 33A-35C are a top view, side view, and bottom view of a reusable housing assembly of the infusion pump assembly of FIGS. 32;

FiG. 36 is an exploded view of the reusable housing assembly of FIGS. 35A-35C; F(G. 3? ia an exploded view of the reusable housing assembly of FJGS. 35A-35C:

FIG. 38A is an exploded view of the reusable housing assembly of FIGS. 35A-35C;

FIG. 38B-3SD are top, side and bottom views of one embodiment of a dust cover; FIGS. 39A-39C are a top view, side view, and bottom view of an electrical control assembly of the reusable housing assembly of FSOS. 35A-35C;

F-IGS, 40A-40C are a top view, side view, and bottom view of a base plate of the reusable housing assembly of FIGS. 35A-35C: FKJS. 41 A-41 B are a perspective top view and a perspective bottom view of ihe base plate of FIGS. 4QA-40C:

FfGS. 42A-42C are a top view, side view; and bottom view of a base plate of the reusable housing assembly of MGS. 35A-35C;

FIGS. 43Λ-438 depici a mechanics! control assembly of the reusable housing assembly of FIGS. 35A-35C

HGS. 44A-44C^' depict the mechanical control assembly of the reusable housing assembly of FIGS, 3SA-35C;

FIGS. 45 A -458 depict ihe pump plunger and reservoir valve of the mechanical control assembly oi^' the reusable housing assembly of FIGS, 35A-35C; RGS. 46A-46E depict various views of ihe plunger pump and reservoir valve of the mechanical control assembly of the reusable housing assembly of FiGS. 33A-35C;

FIGS. 47A-47B depict ihe measurement valve of ihe mechanical control assembly of the reusable housing assembly of FIGS. 35A-35C;

FIG. 48 is an exploded view of ihe disposable housing assembly of ihe in fusion pump assembly of FlG. 32;

FSG. 49A is a plan view of ihe disposable housing assembly of FlO- 48;

FiG. 49 B is a sectional view of the disposable housing assembly of FlG. 49A taken along line B-B;

FIG. 49C is a sectional view of the disposable housing assembly of FiG. 49A taken along line C-C;

FiGS. 50A-50C depict the base portion of the disposable housing assembly of FIG, 48;

RGS. 51Λ-53C depict the fluid pathway cover of the disposable housing assembly of FIG. 48; FIGS. 52A-52C depict the membrane assembly of the disposable housing assembly of FIG. 48;

FIGS. 53A-53C depict the top portion of the disposable housing assembly of F(G. 48; FIGS. 54A-54C depict the valve membrane insert of Ae disposable housing assembly of FΪG. 48;

FIGS, 55A-55B depict the locking ring assembly of the infusion pump assembly of PtG. 32; FiG, 56A-56B depict the locking ring assembly of the infusion pump assembly of

FIG. 32;

FKJS- 57-58 is an isometric view of an infusion pump assembly and a fiiϊ adapter;

FSGS. 59-64 are various views of the fill adapter of RG. 57;

FiG, 65 is an isomeixie view of another embodiment of a fill adapter; FlCiS. 66-6? depict an infusion pump assembly and another embodiment of a fill adapter;

FIGS, 68-74 are various views of the fill adapter of FlG. 66;

FiGS. 75-SO depict various views of an embodiment of a battery charger;

FiGS, B 1-89 depict various embodiments of battery chargers / docking stations; RGS. 90A-9QC are various views of a volume sensor assembly included within the infusion pump assembly of FlG, 1;

FIGS. 91 A-911 are various views of a volume sensor assembly included within the infusion pump assembly of FIG. 1;

FIGS. 92A-921 are various views of a volume sensor assembly included within the infusion pump assembly of FlG. ! ;

FiGS. 93A-93I are various views of a volume sensor assembly included within the infusion pump assembly of FIG. 1;

FIGS. 94Λ-94F are various views of a volume sensor assembly included within the infusion pump assembly of FIG. ! ; FIG. 95 is an exploded view of a volume sensor assembly included within the infusion pump assembly of RG. 1;

FlG, % is a diagrammatic view of a volume sensor assembly included within the infusion pump assembly of FiG. 1 ;

FIG. 97 is a two-dimensiona! graph of a performance characteristic of the volume sensor assembly of FlG. %;

FiG. 98 is a two-dimensional graph of a performance characteristic of the volume sensor assembly of FIG, 96; FlG_r 99 is a two-dimensional graph of a performance characteristic of the volume sensor assembly of FIG. %;

FlG. 100 is a diagrammatic view of a volume sensor assembly included within the infusion pump assembly of FIG, 1; FKλ 101 is a two-dimensional graph of a performance characteristic of the volume sensor assembly of FSG. i 00:

FfG. 101 is a two-dimensional graph of a performance characteristic of the volume sensor assembly of FKl I (K);

FIO, 103 is a diagrammatic view of a volume sensor assembly included within the infusion pump assembly of FlO. 1 ;

FIG. 104 is a two-dimensional graph of a performance characteristic of a volume sensor assembly included within the infusion pump assembly of FlG. ϊ ;

FIG. 105 is a two-dimensional graph of a performance characteristic of a volume sensor assembly included within the infusion pump assembly of FIG. I : FiG. 106 is a two-dimensional graph of a performance characteristic of a volume sensor assembly included within the infusion pump assembly of FIG. I :

FIG. 107 is a two-dimensional graph of a performance characteristic of a volume sensor assembly included within the infusion pump assembly of FIG. 1 :

FIG. 108 is a two-dimensional graph of a performance characteristic of a volume sensor assembly included within the infusion pump assembly of FlG. I :

FIG. 109 is a diagrammatic view of a control mode! for a volume sensor assembly included within the infusion pump assembly of FlG. 1;

FiG. 1 10 is a diagrammatic view of an electrical control assembly for the volume sensor assembly included within the infusion pump assembly of FlG. I ; FIG. I l l is a diagrammatic view of a volume controller for the volume sensor assembly included within the infusion pump assembly of Ff(I I ;

FIG, 1 12 is a diagrammatic view of a feed forward controller of the volume controller of FJG. I l l;

FIGS. 1 13-1 14 diagrammatieaily depicts an implementation of an SMA controller of the volume controller of FiG. i l l;

FIG. 1 14A-! 14B is an alternate implementation of an SMA controller;

FlG. ! 15 diagrammatieally depicts a mufti-processor control configuration that may be included within the infusion pump assembly of FIG. 1; FKλ U 6 is a diagrammatic view of a multi-processor control configuration that may he included within the infusion pump assembly of FlG. t;

FlG. 1 17A- 1 17B diagrammatical Iy depicts multi-processor functionality;

FiG. 1 18 diagrammatical!}' depicts ratshi-processor functionality: FiG, I 19 diagrammatical!}' depicts multi-processor functionality;

RGS. 120A- I20IΞ graphically depicts various software layers;

120B- ! 2OC depict various state diagrams;

S 20D graphically depicts device interaction;

!2OE graphically depieis device interaction; FlG, 121 diagramraatically depicts a volume sensor assembly included within the infusion pump assembly of FiG. 1;

FlG. 122 diagrammaticaHy depicts an inter-conπecϋon of the various systems of the infusion pump assembly of FSG. 1 ;

FfG, 123 diagrammaticaHy depicts basal - bolus infusion events; RG. 124 diagrammatical!}' depicts basal - bolus infusion events;

FIG. 125 A I2G depicts a hierarchial state machine;

FiG. 126A-126M depicts a hierarchial state machine;

FiG. 12? is an exemplary diagram of a split ring resonator antenna;

F!G. 128 is an exemplary diagram of a medical device configured to utilize a split ring resonator antenna;

FiG. 129 is an exemplary diagram of a split ring resonator antenna and transmission line from a medical infusion device;

FiG. 130 is a graph of the return loss of a split ring resonator antenna poor to contact with human skin; FIG. 130A is a graph of the return loss of a split ring resonator antenna during contact with human skin;

FiG, 131 is an exemplary diagram of a split ring resonator antenna integrated into a device which operates within close proximity to dieiectric material;

FIG. 132 is a diagram of the dimensions of the inner and outer portion of the exemplary embodiment;

FiG. ! 3i is a graph of the return loss of a non-split ring resonator antenna prior to contact with human skin; FlG, 133 A is a graph of the return loss of a non-split ring resonator antenna during contact with human skin;

F-IGS, 134 - i45 depict an embodiment of a charger, including various perspective views, exploded views, and partial Sy exploded views; FΪGS. 146-148 are schematics of an exemplary electrical system that may be utilised in connection with the charger of FiGS. 134- 145;

FfGS. 149-173 show various additional embodiments of a charger, as well as various features of such additional embodiments;

FiOS. 174-193 depict various views and aspects of an embodiment of a fill adapter; FJGS. 194-198 depict various views and aspects of another embodiment of a till adapter;

FIGS, 199A- !99H depicts a sequential cross sectional view of one embodiment of the fill adapter in operation;

FfO, 200 is an exploded view of one embodiment of a fill adapter; RG. 201 is an isometric view of a fill adapter base according to one embodiment;

FIG. 202A-202B are isometric views of the vial adapter according to one embodiment;

FiGS. 203A-2G3K depicts a sequential cross sectional view of one embodiment of the fill adapter in operation; FiGS. 204A-204C is a cross section view of a sequence of the fill adapter in operation, without a vial, according to one embodiment; and

FiG. 205 shows one embodiment of a system for verification of volume and pumping.

Like reference symbols in the various drawings indicate Site elements.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FSGS. 1-3, an infusion pump assembly 100 may include a reusable housing assembly 102, Reusable housing assembly 102 may be constructed from any suitable material such as a hard or rigid plastic, that will resist compression. For example, use of durable materials and parts may improve quality and reduce costs by providing a reusable portion that ia.sts longer and. is more durable, providing greater protection to components disposed therein. Reusable bousing assembly 102 may include mechanical control assembly 104 having a pump assembly S 06 and at least one valve assembly 108. Reusable housing assembly 102 may txho include electrical control assembly ! 10 configured to provide one or more control signals to mechanical control assembly 104 and effectuate the basal and/ or bolus delivery of an infusible tluid to a user. Disposable housing assembly 1 14 may include valve assembly 108 which may be configured to control the Row of the infusible fluid through a fluid path. Reusable housing assembly 102 may also include pump assembly 106 which may be configured Io pump the infusible fluid from the fluid path to the user.

Electrical control assembly 1 10 may monitor and control the amount of infusible fluid that has been ami/or is being pumped. For example, electrical control assembly 1 10 may receive signals from volume sensor assembly 148 and calculate the amount of infusible llυid that has just been dispensed and determine, based upon the dosage required by ihe user, whether enough infusible fluid has been dispensed. If enough infusible fluid has not been dispensed, electrical control assembly 1 10 may determine that more infusible fluid should be pumped. Electrical control assembly 1 10 may provide the appropriate signal to mechanical control assembly 104 so that any additional necessary dosage may be pumped or electrical control assembly 1 10 may provide the appropriate signal to mechanical control assembly 104 so that the additional dosage may be dispensed with the next dosage. Alternatively, if too much infusible fluid has been dispensed, electrical control assembly 1 10 may provide the appropriate signal to mechanical control assembly 104 so that less infusible fluid may be dispensed in the next dosage.

Mechanical control assembly 104 may include at least one shape-memory actuator 1 12. Pump assembly 106 and/or valve assembly 108 of mechanical control assembly 104 may be actuated by at least one shape-memory actuator, e.g., shape-memory actuator 1 12, which may be a shape-memory wire in wire or spring configuration. Shape memory actuator 1 12 may be uperabiy connected to and activated by electrical control assembly ! H), which may control the timing and the amount of heat and/or electrical energy used to actuate mechanical control assembly 104. Shape memory actuator 1 12 may be, for example, a conductive shape-memory alloy wire that changes shape with temperature. The temperature of shape-memory actuator 1 12 may be changed with a heater, or more conveniently, by application of electrical energy. Shape memory actuator 1 12 may be a shape memory wire constructed of nickel/titanium alloy, such as NITSNGL™ or FLEXfNOL®. infusion pump assembly 100 may include a volume sensor assembly 148 configured to monitor the amount of fluid infused by infusion pump assembly 100. For example, volume sensor assembly 148 may employ, for example, acousiic volume sensing. 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, as well as U.S. patent application

Publication Nos. US 2007/0228071 A L US 2007/02104% AI, US 2007/0219480 AL US 2007/0219597 AL the entire disclosures of all of which are incorporated herein by reference. Other alternative techniques for measuring fluid How may also be used; for example, Doppter-based methods; the use of Hall-effect sensors in combination with a vane or flapper valve; the use of a strain beam (for example, related to a flexible member over a fluid reservoir to sense deflection of the flexible member); the use of capacitivε sensing with plates; or thermal time, of flight methods. One such alternative technique is disclosed in U.S. Patent app Heat ion Serial No, 1 1/704,899, entitled Fluid Deliver}' Systems and Methods, filed 09 February 2007, the entire disclosure of which is incorporated herein by reference, infusion pump assembly 100 may be configured so that the volume measurements produced by volume sensor assembly 148 may he used to control through a feedback loop, the amount of infusible fluid thai is infused into the user.

Infusion pump assembly 100 may further include a disposable housing assembly 1 14. For example, disposable housing assembly 1 I 4 may be configured for a single use or for use for a specified period of time, e.g., three days or any other amount of time.

Disposable housing assembly 114 may be configured such that any components in infusion pump assembly S 00 that come in contact with the infusible fluid are disposed on and/or within disposable housing assembly 1 14. For example, a fluid path or channel including a reservoir, may be positioned within disposable housing assembly i 14 and may be configured for a single use or for a specified number of uses before disposal. The disposable nature of disposable housing assembly 1 14 may improve sanitation of infusion pump assembly 100.

Referring also to FKJ-. 4, disposable housing assembly 1 14 may be configured to releasably engage reusable housing assembly 102, and includes a cavity S 16 that has a reservoir 1 18 for receiving an infusible fluid (not shown), e.g., insulin. Such reteasable engagement may be accomplished by a screw-on, a twist-lock or a compression lit configuration, for example. Disposable housing assembly ! 14 and/or reusable housing assembly 102 may include an alignment assembly configured to assist in aligning disposable bousing assembly 1 14 and reusable bousing assembly 102 for engagement in a specific orientation. Similarly, base nub 120 and top nub 122 may be used as indicators of alignment and complete engagement.

Cavity i 16 may be at least partially formed by and integral to disposable housing assembly 1 14. Cavity 1 16 may include a membrane assembly 124 for at least partially defining reservoir ! 18. Reservoir 1 S S may be further defined by disposable housing assembly i 14, e.g., by a recess 126 formed in base portion 128 of disposable housing assembly 1 14. For example, membrane assembly 124 may be disposed over recess 126 and attached to base portion 128, thereby forming reservoir 1 IS, Membrane assembly 124 may be attached to base portion 128 by conventional means, such as gluing, heat sealing, and/or compression fitting, such that a seal 130 is formed between membrane assembly 124 and base portion 128. Membrane assembly 124 may be flexible and the space formed between membrane assembly 124 and recess 126 in base portion 128 may define reservoir 1 18, Reservoir 1 18 may be non-pressurized and in fluid communication with a fluid path (not shown). Membrane assembly 124 may be at least partially collapsible and cavity 1 16 may include a vent assembly, thereby advantageously preventing the buildup of a vacuum in reservoir 1 18 as the infusible fluid is delivered from reservoir 118 to the fluid path. In a preferred embodiment, membrane assembly 124 is fully collapsible, thus allowing for the complete delivery of the infusible fluid. Cavity 1 16 may be configured to provide sufficient space to ensure there is always some air space even when reservoir 1 1 S is filled with infusible fluid.

The membranes and reservoirs described herein may be made from materials including bul not limited to silicone, NITRILE, and any other material having desired resilience and properties for functioning as described herein. Additionally, other structures could serve the same purpose.

The use of a partially collapsible non pressurized reservoir may advantageously prevent the buildup of air in the reservoir as the fluid in the reservoir is depleted. Air buildup in a vented reservoir could prevent fluid egress from the reservoir, especially if the system is tilted so that an air pocket intervenes between the fluid contained in the reservoir and the septum of the reservoir. Tilting of the system is expected during normal operation as a wearable device.

Reservoir 1 S 8 may be conveniently sized to hold an insulin supply sufficient for deliver)' over one or more days. For example, reservoir 118 may hold about 1.00 to 3.00 ml of insulin. A 3.00 mi insulin reservoir may correspond to approximately a three day supply for about 90% of potential users. In other embodiments, reservoir ! 18 may he any size or shape and may be adapted to ^"hold any amount of insulin or other infusible fluid. In sonic embodiments, the size and shape of cavity i 16 and reservoir HS is related to the type of infusible fluid that cavity 1 16 and reservoir 1 18 are adapted to hold.

Disposable housing assembly S S 4 may include a support member 132 (FlQ. 3) configured to prevent accidental compression of reservoir 1 IS. Compression of reservoir 1 18 may result in an unintentional dosage of infusible fluid being forced through the fluid path to the user, In a preferred embodiment, reusable boosing assembly 102 and disposable housing assembly 1 14 may be constructed of a rigid materia! that Ls not easily compressible. However, as an added precaution, support member 132 may be included within disposable housing assembly S 14 to prevent compression of infusion pump assembly 100 and cavity 1 16 therein. Support member 132 may be a rigid projection from base portion I2S. For example, support member 132 may be disposed within cavity 1 16 and may prevent compression of reservoir 1 18.

As discussed above, cavity 1 16 may he configured to provide sufficient space to ensure there is always some air space even when reservoir 1 18 is Hl led with infusible fluid. Accordingly, in the event that infusion pump assembly 100 is accidentally compressed, the infusible fluid may not be forced through cannula assembly 136 {e.g., shown in FlG. 9). Cavity 1 16 may include a septum assembly 146 (FKi 3) configured to allow reservoir 1 18 to be filled with the infusible fluid. Septum assembly 146 may be a conventional septum made from rubber or plastic and have a one-way fluid valve configured to allow a user to fill reservoir 1 18 from a syringe or other tilling device. In some embodiments, septum 146 may be located on the top of membrane assembly 124. In these embodiments, cavity 1 16 may Include a support structure (e.g., support member 132 in RG. 3) for supporting the area about the back side of the septum so as to maintain the integrity of the septum seal when a needle is introducing infusible fluid into cavity ! 16. The support structure may be configured to support the septum while still allowing the introduction of the needle for introducing infusible fluid into cavity 1 16. Infusion pump assembly 100 may include an overfill prevention assembly (not shown) that may e.g., protrude into cavity L 16 and may e.g., prevent the overfilling of reservoir 1 18. in some embodiments, reservoir i 18 may be configured to be filled a plurality of times. For example, reservoir 1 18 may be refutable through septum assembly 146. As infusible fluid may be dispensed to a user, electronic control assembly 1 10 may monitor the fluid level of the infusible fluid in reservoir 1 18. When the fluid level readies a low point, electronic control assembly 1 10 may provide a signal, such as a light or a vibration, to the user that reservoir 118 needs to be refilled. A syringe, or other filling device, may be used to fill reservoir I ! 8 through septum 146.

Reservoir 1 1 S may be configured to be filled a single time. For example, a refill prevention assembly tnot shown) may be utilized to prevent the refilling of reservoir 1 18, such that disposable housing assembly 114 may only be used once. The refill prevention assembly (not shown I may be a mechanical device or an electro-mechanical device. For example, insertion of a syringe into septum assembly 146 for tilling reservoir 118 rosy trigger a shutter to close over septum 146 after a single tilling, thus preventing future access to septum 146, Similarly, a sensor may indicate to electronic control assembly 1 10 that reservoir 118 has been filled once and may trigger a shutter to close over septum 146 after a single filling, thus preventing future access to septum 146. Other means of preventing refilling may be utilized and are considered to be within the scope of this disclosure,

As discussed above, disposable housing assembly 1 14 may include septum assembly 146 that may be configured to allow reservoir 1 18 to be tilled with the infusible fluid. Septum assembly 146 may be a conventional septum made from rubber or any other material that may function as a septum, or, m other embodiments, septum assembly 146 may be, but is not limited to, a plastic, or other material, one-way fluid valve, in various embodiments, including the exemplar}' embodiment, septum assembly 146 is configured to allow a user to fill reservoir 1 18 from a syringe or other filling device. Disposable housing assembly 1 14 may include a septum access assembly that may be configured to limit the number of times that the user may refill reservoir 1 18.

For example and referring also to FIGS. 5A-5C, septum access assembly 152 may include 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 penetrating septum 146 with filling syringe 160, shutter assembly 154 may be displaced downward, resulting in tab assembly ! 56 disengaging from slot assembly 15 S. Once disengaged, spring assembly 162 may displace shutter assembly 154 in the direction of arrow 164, resulting in septum 146 no longer being accessible to the user, Referring also to FlG. 6 A, an altemaiive-embodiment septum access assembly 166 is shown in the "open" position. In a fashion similar to that of septum access assembly 152, septum access assembly 166 includes shutter assembly 168 and spring assembly 1 70.

Referring also to FlG. 6B, an alternative-embodiment of septum access assembly 172 is shown in the "open'^' position where tab 178 may engage slot 180, In a fashion similar to that of septum access assembly 166, septum access assembly 172 may include shutter assembly { 74 and spring assembly 176. Once shutter assembly I 72 moves to the "closed" position (e.g., which may prevent further access of septum 146 by the user), tab 178 may at least partially engage slot ISOa, Engagement between tab ! 78 and slot !8Oa may lock shutter assembly J 72 in the "closed" position to inhibit tampering and reopening of shutter assembly 172. Spring tab 182 of shutter assembly 172 may bias tab 178 into enaarøϊient with slot 180a.

However, in various embodiments, septum access assemblies may not be actuated linearly. For example and referring also U* FfCiS. 7Λ-7B, there is shown alternative embodiment septum access assembly 184 that includes shutter assembly i S6 mat is configured to pivoi about axis 188. When positioned in the open position (as shown in FlG. 7A), septum 146 may be accessible due to passage 190 {in shutter assembly 186) being aligned with passage 192 in e.g., a surface of disposable housing assembly i 14. However, in a fashion similar to septum access assemblies 166, 172, upon penetrating septum 146 with filling syringe 160 (See FIG. 6B), shutter assembly S 86 may be displaced in a clockwise fashion, resulting in passage 190 (in shutter assembly 186) no longer being aligned with passage 192 in e.g., a surface of disposable housing assembly S 14, thus preventing access to septum 146.

Referring also to FIGS. 8A-88, an alternative-embodiment septum access assembly 194 is shown. In a fashion similar to that of septum access assemblies 166, 172, septum access assembly 194 includes shutter assembly 196 and spring assembly Ϊ98 that is configured io bias shutter assembly 196 in the direction of arrow 200. Filling assembly 202 may be used to HSS reservoir 1 1 8. Filling assembly 202 may include shutter displacement assembly 204 that may be configured to displace shutter assembly 196 in the direction of arrow 206, which in turn aligns passage 208 hi shutter assembly 196 with septum 146 and passage 210 in septum access assembly 194, thus allowing filling syringe assembly 212 to penetrate septum 146 and fill reservoir 1 18. infusion pump assembly 100 may include a sealing assembly ISO (FlG, 3) configured to provide a seal between reusable housing assembly 102 and disposable housing assembly S 14, For example, when reusable housing assembly 102 and disposable housing assembly 1 M are engaged by e.g. rotational screw-on engagement, twist-iock engagement or compression engagement, reusable housing assembly 102 and disposable housing assembly i 14 may fit together snuggly, thus forming a seal. In some embodiments, it may be desirable for the seal to be more secure. Accordingly, sealing assembly 150 may include an o-ring assembly (not shown). Alternatively, scaling assembly 150 may include an over molded seal assembly {not shown), The use of an o-ring assembly or an over molded seal assembly may snake the seal more secure by providing a compressible rubber or plastic layer between reusable housing assembly 102 and disposable housing assembly 1 14 when engaged thus preventing penetration by outside fluids. In some instances, ihe o- ring assembly may prevent inadvertent disengagement. For example, sealing assembly S 50 may be a watertight seal assembly and, thus, enable a user to wear infusion pump assembly 100 while swimming, bathing or exercising.

Referring also to FiG. 9, infusion pump assembly 100 may include an external infusion set 134 configured to deliver the infusible fluid to a user. External infusion set 134 may be in fluid communication with cavity 1 18, e.g. by way of the fluid path. External infusion set. 134 may be disposed adjacent to infusion pump assembly 100. Alternatively, external infusion set 134 may be configured for application remote from infusion pump assembly 100, as discussed in greater detail below. Externa! infusion set 134 may include a cannula assembly 136, which may include a needle or a disposable cannula I3S, and tubing assembly 140. Tubing assembly 140 may be in fluid communication with reservoir ! 18, for example, by way of the fluid path, and with cannula assembly 138 for example, either directly or by way of a cannula interlace 142.

External infusion set 134 may be a tethered infusion set, as discussed above regarding application remote from infusion pump assembly SOO. For example, external infusion set 134 may be in fluid communication with infusion pump assembly 100 through tubing assembly 140, which may be of any length desired by the user (e.g., 3-18 inches). ^"though infusion pump assembly 100 may be worn on the skin of a user with {he use of adhesive patch 144, the length of tubing assembly 140 may enable the user to alternatively wear infusion pump assembly 100 in a pocket. This may be beneficial to users whose skin is easily irritated by application of adhesive patch 144. Similarly, wearing and/or securing infusion pump assembly 100 m a pocket may be preferable for users engaged in physical activity.

In addition to / as an alternative to adhesive patch 144, a hook and loop fastener system (e.g. such as hook and loop listener systems offered by Velcro USA inc. of Manchester. NH) may be utilized to allow for easy attachment ^l removal of an infusion pump assembly (e.g., infusion purøp assembly IiKi) from the user. Accordingly, adhesive patch 144 may be attached to the skin of the user and may include an outward facing hook or loop surface. Additionally, the lower surface of disposable housing assembly 114 may include a complementary hook or loop surface. Depending upon the separation resistance of the particular type of hook and loop fastener system employed, ii may be possible for the strength of the hook and loop connection to be stronger than the strength of the adhesive to skin connection. Accordingly, various hook and loop surface patterns may be utilized to regulate the strength of the hook and loop connection.

Referring also to FΪGS. 1 OA-K⁾E, five examples of such hook and loop surface patterns are shown. Assume for illustrative purposes that the entire lower surface of disposable housing assembly 1 14 is covered in a "loop" material. Accordingly, the strength of the hook and loop connection may be regulated by varying the pattern (i.e., amount) of the "hook" material present on the surface of adhesive patch 144. Examples of such patterns may include but are not limited to: a singular outer circle 220 of "'hook'¹ material (as shown in FIG. I OA); a plurality of concentric circles 222, 224 of "hook" material (as shown in FlG. 10B); a plurality of radial spokes 226 of "hook" material fas shown in FIG. IOC); a plurality of radial spokes 228 of "hook" materia! in combination with a single outer circle 230 of "hook" material (as shown in FlG. I OD); and a plurality of radial spokes 232 of "hook" material in combination with a plurality of concentric circles 234, 236 of "hook" material (as shown in FIG. 10E⁾.

Additionally and referring also to FfCI I IA, in one exemplary embodiment of the above-described infusion pump assembly, infusion pump assembly 100" may be configured via a remote control assembly 300. In this particular embodiment, infusion pump assembly 100' may include telemetry circuitry (not shown) that allows for communication (e.g., wired or wireless) between infusion pump assembly 100' and e.g., remote control assembly 300, thus allowing remote control assembly 300 to remotely control infusion pump assembly UW. Remote control assembly 300 (which may also include telemetry circuitry (not shown) and may be capable of communicating with infusion pump assembly 100') may include display assembly 302 and input assembly 304. livpui assembly 3(H may include slider assembly 306 and switch assemblies 308. 310. In other embodiments, the input assembly may include a jog wheel a plurality of switch assemblies, or the like.

Remote control assembly 300 may include the ability to pre-program basal rates, bolus alarms, delivery limitations, and allow the user to view history and to establish user preferences. Remote control assembly 300 may also include a glucose strip reader.

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 S 00 \ Accordingly, the user may use remote control assembly 300 to program / configure infusion pump assembly 100'. Some or all of the communication between remote control assembly 300 and infusion pump assembly 100^" may be encrypted to provide an enhanced level of security .

Communication between remote control assembly 300 and infusion pump assembly 100^" may be accomplished utilizing a standardized eomniυnieaiion protocol, Further, communication between the various components included within infusion pump assembly 100, SOO' may be accomplished using the same protocol. One example of such a communication protocol is the Packet Communication Gateway Protocol (PCGP) developed by DBKA Research & Development of Manchester, NM As discussed above, infusion pump assembly 100, 100' may include electrical control assembly 1 10 that may include one or more electrical components. For example, electrical control assembly 1 10 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, UW to communicate with remote control assembly 300. Further, remote control assembly 300 may include one or more electrical components, examples of which may include bin 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 diagrammatic view of one example of such a system is shown in FIG. 1 IB.

Each of these electrical components may be manufactured from a different component provider and, therefore, may utilize native (i.e. unique) communication commands. Accordingly, through the use of a standardized communication protocol, efficient communication between such disparate components may be accomplished. PCGP may be a flexible extendable software module ihat may be used on the processors within infusion pump assembly 100, 100' and remote control assembly 300 to build and route packets, FCGP may abstract the various interfaces and may provide a unified application programming interface (APf) to the various applications being executed on each processor. PCGP may also provide an adaptable interlace to the various drivers. For illustrative purposes only, PCGP may have the conceptual structure illustrated in F(G. I iC for any given processor,

PCGP may ensure data integrity by utilizing cyclic redundancy checks (CRCs). PGGP may also provide guaranteed delivery status. For example, nil new messages should have a reply. If such a reply isn't sent back in time, the message may time out and PCGP may generate a negative acknowledge reply message for the application (i.e., a NACK). Accordingly, the message-reply protocol may Set the application know whetiier the application should retry sending a message.

PCGP may also limit the number of messages In-flight from a given node, and may be coupled with a flow-control mechanism at the driver level to provide a deterministic approach to message delivery and may let individual nodes have different quantities of buffers without dropping packets- As a node runs out of buffers, drivers may provide back pressure to other nodes and prevent sending of new messages.

PCXJP may use a shared buffer pool strategy to minimize data copies, and may avoid mutual exclusions, which may have a small affect on the AF! used to send / receive messages to the application, and a larger affect on the drivers. PCGP may use a "Bridge" base class that provides routing and buffer ownership. The main PCGP class may be subclassed from the bridge base class. Drivers may either be derived from a bridge class, or talk to or own a derived bridge class.

PCGP may be designed to work in an embedded environment with or without an operating system by using a semaphore to protect shared data such that some calls can be re-entrant and run on a multiple threads. One illustrative example of such an implementation is shown in FJG. I ID. PCGP may operate the same way in both environments, but there may be versions of the call for specific processor types (e.g., the ARM 9 / OS version) So while the functionality may be the same, there may be an operating system abstraction layer with slightly different calls tailored for e.g., the ARM 9 Nucleus OS envircmϊϊient.

Referring also to FlG. 11 E, PCGP may:

• allow multiple Send / Reply calls to occur (on Pilot's ARM 9 on multiple tasks re-entrant); * have multiple drivers running asynchionously for RX ami TX on different interfaces; and

• provide packet ordering for send / receive, and deterministic timeout on message send.

5 Each software object may ask the buffer manager for the next butler to use, and may then give that bulϊer to another object Buffers may pass from one exclusive owner to another autonørøicly, and queues may occur automatically by ordering buffers by sequence number. When a buffer is no longer in use, the buffer may be recycled (e.g., object attempts to give the buffer to itself, or frees it for the buffer manager to reallocate later). Accordingly, data generally doesn't need to be copied, and routing simply writes over the buffer ownership byte.

Such an implementation of PCCiP may provide various benefits, examples of which may include but arc not limited to;

• dropping a message due to lack of buffers may be impossible, as once a message is put into a buffer. the message may live there until it is transferred or received by the application;

• data may not need to be copied, as offsets are used to access driver, PCOP and payload sections of a buffer;

• drivers may exchange ownership of message data by writing over one byte (i.e., the buffer ownership byte K

• there may be no need for multiple exclusions except for re-entrant calls, as a mutual exclusion nay be needed only when a single buffer owner could simultaneously want to use a buffer or get a new sequence number;

* there may be fewer rules for application writers to follow to implement a reliable system;

* drivers may use ISR / push / ptil! and polled data models, as there are a set of calls provided to push / pull data out of die buffer management system from the drivers;

* drivers may not do much work beyond TX and RX₁ as drivers may not copy, CRC or cheek anything but the destination byte and CRC and other checks may^¬ be done off of the ISR hot path iaier;

♦ as the buffer manager may order access by sequence number, queue ordering may automatically occur; and

* a small code / variable foot print may be utilized; hot path code may be small and overhead may be low,

As shown in FIG. 1 1 F, when a message needs to be sent, the PCCiP may build the packet quickly and may insert it into the buffer management system. Once in the buffer management system, a call to "packetProeessor" may apply protocol rules and may give the messages to the drivers / application. 0 To send a new message or send a reply, FCGP may: • check the call arguments to e.g., make sure ihe packet length is legal, destination Is ok, eic;

• avoid trying to send a message across a link that h down unless the down link is the radio node, which may allow PCGP to be used by the radio processors to

5 establish a link, pair, etc. and may notify the application when PCGP is trying to talk across a link that is not functional i instead of timing out };

• obtain a sequence number lor a new message or utilize an existing sequence number for an existing message;

• build the packet, copy the pay load data and write in the CRC\ wherein ( from this point forward) tile packet integrity may be protected by the CIlC; and

• either give the message to the butter manager as a reply or as a new message, and check to see if putting this buffer into the buffer manager would exceed the maximum number of en-queued .send messages.

Referring also to RGS. S IG-I ! M. PCXJP may work by doing all of the main work on one thread to avoid mutual exclusions, and to avoid doing considerable work on the send / reply or driver calls. The "packeiProeessor" call may have to apply protocol rules to replies, new sent messages, and received messages. Reply messages may simply get routed, but new messages and received messages may have rules for routing the messages. In each case, the software may loop while a message of the right type is available to apply protocol rules until it cannot process the packets.

Sending a new message may conform to the following rules:

• only two messages may be allowed "in-flighr on the network; and

• enough data about an in-flight message may be stored to match the response and handle timeout.

Receiving a message may conform to the following rules:

• responses that match may clear out the "in-flight" information slot so a new- packet can be sent;

• responses that do not match may be dropped; ♦ new messages may be for the protocol (e.g., getting / clearing network statistics for this node);

• to receive a message, the buffer may be given up to the application and may use a cal S back; and

• the buffer may be freed or left owned by the application. Accordingly, PCGP may be configured such that:

• the call back function may copy the payload data out or may use it completely before returning;

• the call back function owns the buffer and may reference the buffer and the buffer's payload by the payload address, wherein the message may be processed0 later;

• applications may poll the FCGP system for received messages; and * applications may use the call back to sei an event and then poll for received messages.

The communication system may have a limited number of buffers. When PCGP runs out of buffers, drivers may stop receiving new packets and the application may be told that the application cannot send new packets. To avoid this and maintain optimal performance. the application may try to perform one or more procedures, examples of which may include but are not limited to;

a} The application should keep FCGP up to date with radio status: Specifically, if the link goes down and PCGP doesn't know, PCGP may accept and queue new messages to send (or not timeout messages optimally), which may jam the send queue and delay the application from using the link optimally.

b) The application should call "decrement timeouts" regularly: Optimally, every 20-100 milliseconds unless the processor is asleep. In general, a message moves fast (milliseconds) slow {seconds} or not at all. Timeouts are an attempt to remove 'in-fiighf messages that should be dropped to free up buffers and bandwidth. Doing this less often may delay when a new message gets sent, or when the application can queue a new message,

c) The application should ask PCGP if it has work to do that is pending before going to sleep: If PCGP lias nothing to do, driver activity may wake up the system and thus PCGP, and then PCCiP won't need a call to "packet Processor" or "decrement timeouts" until new packets enter the system. Failure to do this may cause messages that could have been sent / forwarded / received successfully to be dropped due Io a timeout condition.

d) The application should not hold onto received messages indefinitely: The message system relies on prompt replies. !f ihe application is sharing PCGP buffers, then holding onto a message means holding onto a PCGP butter. The receiving node doesn't know if the sending node has timeout configured for slow or fast radio. This means when a node receives a message it should assume the network's fast timeout speed.

e) The application should call the "packetProcessor" often: The call may cause- new messages queued by the application to get sent and may handle receipt of new messages. The call may also cause buffers to re-allocate and calling it infrequently may delay message traffic.

As shown in FIG. 1 11, at some point the RX driver may be asked to receive a message from the other side of the interface. To ensure a message does not get dropped, the RX driver may ask the buffer manager if there is an available buffer for storing a new message. The driver may then ask for a buffer pointer and may start filling the buffer with received data. When a complete message is received, the RX driver may calf a function to route the packet. The route function may examine the destination byte in the packet header and may change the owner to either the other driver, or the application, or may detect that the packet is bad and may drop the packet by freeing the buffer.

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

■? Rece i ve request uin l B i -0 , * p; i t: ( B?: i ckj'i: : : 03;>k<κ:^;:: iveFΪ OwCocs k ϊ oJ ( ) ) p ■■ Br idge : ; -V=XtBa S f erPX ( ) ; whi l e (not 'ior;4 j i p [ i ] «^■ the next byre? ;

Bridqe : : route ''p s t :»

A driver may perform a TX by asking the buffer manager for the pointer to the next buffer to send. The TX driver may then ask the other side of the interface if it can accept a packet. If the other side denies the packet, the TX driver may do nothing to the buffer, as its status has not changed. Otherwise, the driver may send the packet, and may recycle / free the buffer. An example of code that performs such a function is as follows: ι!i n.tθ ⁺p -• B.r kkκ? : mext.Bυ f i ;?rTX ( ) ,- i f { p ! ^{■■■■■} ( uim: » * } 0 ) ssv,d the bu f fer p; B?: :i dφ;: ; : J: ecy^;::.L^;;_: «^'p} ;

To avoid forwarding packets that are past the maximum message system timeout time, asking for the next Buffer may call the BulTerManager::fϊrst(uiat8 owner) function that may scan for buffers to free. Accordingly, full TX buffers with no hope of making a timeout may be freed on the thread that owns die buffer. A bridge that is doing TX (i.e. , while looking for the next TX buffer) may free all of the TX buffers that are expired before receiving the next TX buffer for processing.

As shown in FIG. i IJ- I I L, during the buffer allocation process, buffers marked free may be transferred to the drivers to receive new packets, or to PCGP to receive new payloads for TX. Allocation from "free" may be done by the "packetProcessor" function. The number of sends and receives between "packelProcessor" calls may dictate how many LTJ>river_RX, GTJDriver_^RX and PCGPJ-reε buffers need to be allocated. LTJDriver may represent drivers thai handle addresses that are less than the node address. GT Driver may represent drivers that handle addresses thai are greater than the node address. When a driver receives a packet, lhe driver may put the data into an RX buffer that gets handed to the router. The router may then reassign the butler to PCGP_Receive or to the other driver^'s TX (not shown). If the buffer contains obviously invalid data, the buffer may transition to free. After a router marks a bulϊer for TX, the driver may discover the buffer is TX and may send the message. After sending the message, the buffer may immediately become an RX buffer if the driver was low in RX buffers, or the buffer may be freed for re-allocation.

Daring the "packet Processor" call, PCGP may process al! buffers that the router marked as PCGP Receive, At this point, data may be acted upon, so the CRC and other data items may be checked. If the data is corrupted, a statistic may be incremented and the buffer may be freed. Otherwise, the butler may be marked as owned by the application. Buffers marked as owned by the application may be either recycled for the use of PCGP or freed for real location by the buffer manager.

When the application wants to send a new message, it may be done in a re-entrant friendly / mutual exclusion manner. If the buffer may be allocated, PCXiP may mark the butler as busy. Once marked busy, no other thread calling the scud or reply functions may grab this buffer, as it is owned by this Junction call's invocation. The remainder of the process of error checking and building the message may be done outside the isolated race condition mutual exclusion guarded code. The buffer may either transition to free or may become a valid filled CR€~checked buffer and passed to the router. These buffers may not be routed immediately and may be queued so that messages can be sent later (assuming that protocol rules allow). Reply messages may be marked differently than new send messages because reply messages may be routed with a higher priority than regular send messages and reply messages may have no rules limiting bow many / when they cars be sent. PCGP was designed to work with flow control and How control may negotiate the transfer of messages from one node to another node so that a buffer is never dropped because the other side of an interface lacks a buffer (which may cause back pressure ou the sending node).

Flow control may be apart of the shared buffer format. The first two bytes may be reserved for the driver so that the driver never needs to shift the packet bytes. Two bytes may be used so that one byte is the DMA length -- 1, and the second byte is to control the How of messages. These same two bytes may be synchronizing bytes if a PCGP message is transmitted over RS232. When a packet is "in-tlighf, the packet may be in the process of being sent by a driver on the way to us destination, being processed by the destination, or being sent hack as a response.

Typical delays are as follows;

Accordingly, messages fend to complete .he røund trip either: quickly (e.g., <50 røs); slowly (e.g., one or more seconds): or not at ail.

FCGP may use two different ϋmes (set at initialization} for all timeouts, one for when the RF link is in fast heartbeat mode, and another for when the RF link is in slow mode. If a message is in-flighi and the link status changes from iasi to slow, the timeout may be adjusted and the difference between fast and slow maybe added to the time-to-Uve counter for the packet, No additional transitions back and forth may affect the time-to-iive time for the message.

There is a second timeout that may be twice as long as the slow timeout that is used to monitor buffer allocation inside PtXiP. Accordingly, if a message is "stuek" inside a driver and hasn^'t been sent dise to e.g., flow control or hardware damage, the buffer may be freed by the buffer manager, resulting in the buffer being dropped. For a "new" message, this may mean that the packet already timed out and the application was already given a reply saying the message wasn't delivered, resulting in the buffer being freed. Since the driver polls the buffer manager for butlers that need to be sent, the buffer is freed up so that a message that could be sent is handed to the driver the next time that it unblocks. For a reply message, the reply may simply get dropped and the sending node may time out.

The PCGF messaging system may pass messages that contain header information and payload. Outside of PCXJP. the header may be a set of data items in a call signature. However, internal to PCGP, there may be a consistent, driver friendly byte layout. Drivers may insert bytes either into the PCGP packet or before the PCGP packet such;

• DE, CA: Synch bytes for use with RS232, nominal value of OxDE, OxCA or 0x5 A, OxAi. • LD; Driver DMA lengih byιe₅ equals amount driver is pushing in this DMA transfer, which is the total size, τioι including the size byte or synch bytes.

• Cmd: Driver command and control byte used for flow control.

• LP-. PCCiP packet length, always the total header ÷ pay load size in bytes ^■*^• CRC size. LD - LP H .

• Dst: Destination address.

• Src: Source address

• Cmd: Command byte

• Sed: Sub command byte * AT: Application Tag is defined by the application and has. no significance to

S³CXJP. it allows the application to attach more information to a message e.g., the thread from which the message originated.

• SeqNum: thirty -two bit sequence number is incremented by PCGP for a new message sent, guarantees the number will not wrap, acts as a token, endianess Isn't relevant,

• CRC 16: A sixteen bit CRC of the PCG P header and payload.

An example of a message with no payload, cmd~L subcmd~2 is as follows;

OxDE, ϋκCA, O KC , O XS , 0 X1 4 , ] , .? , 0 , 0 , 0 , 0 , f-x^'l , c fv^ iqh, C E Ci OW .

C ϊ <: lOw ,

There may be several advantages to this methodology, examples of which may include but are not Km i ted to: • Most of our hardware DMA engines may use the first byte to define how many additional bytes to move, so in this methodology, drivers, and PCGP may share buffers,

♦ A byte may he provided right after the DMA length to pass flow control information between drivers. • Driver length and "Cmd" byie may be outside the CRC region so they may be altered by the driver, may be owned by the driver transport mechanism, and the driver may guard for invalid lengths.

♦ There may be a separate PGCP packet length byte that is CRC protected. Accordingly, the application may trust the that payload length is correct, • The endianπess of the sequence number may not be relevant, as it is just a byte pattern that, may be matched that happens to also be a thirty-two bit integer.

♦ The sequence number may be four bytes aligned to the edge of the shared buffer pool length.

♦ There may be optional RS232 synchronizing bytes so that users may move cables around while debugging a message stream and both sides of the interlace may resynchronke

♦ The application, driver and FCGP may share buffers and may release them by pointer. PCGP may not be an event driven software design, but may be used in event driven architectures by how the sub-classes are written. Data may be exchanged between the classes conceptually (as shown in FIG. 1 1 M-I I N).

Some event mode! in the driver may wake the driver, may receive a message and may pass the message through the bridge into the buffer manager that routes the message to new owner of the new message {through a bridge to either a driver or PCGP).

The following summarizes some exemplary events;

The following illustrative example shows how the PCGP event model may work with Nucleus to wakeup the PCGP task after every message send, reply, or dec-Timeout that generated a NACfC: c La sy PcqpOS : publ ic Pcqp

^■« j. ;: t,:.iά 1 void s.ch€κk3 iδP;ϊc ket Px¹oc^j;;sso}: (vo i.d ϊ i

OS EventOrp Ber (« RCVEvGrpslEVG RK^' TASKi .pEvgHandie,

RrP.^'udxoTxfvζ-rl;:, OS EV ORJ4O C;,KΛR) ;

The following is a pseudo code driver that is event based, illustrating how driver events work. The Driver subclasses Bridge and overrides hasMcssagesToScnd and ilowControiTumedOlTto schedule the TX and RX functions to run if they aren't, already running, olass 3PΪ DrivsK : public Bridge viπ;ua i. void hasMessagesToSeruϊ { )

Tϊ-iαqe!c_ΪSR (τX_ΪSR, t.h isϊ ; /irtual void f lgwCorstrQlTiU'n^JOέf { }

Tr: i gger LSP f RX__i SP_r t his} ;

static void TX Retrylimβr { ) Triααes: ISR (TX ΪSR, tϊ:isi ;

static 'SX iόKtbrxααe ^%r>) Disable SR<; π ; do

5 if (p ^■«■«^■ n^:-;l-U bif≥ak;

11: <t>~> biil:i:e;:Mana'3er:->buf i:^ϊTλfϊ;-idOuu (p) "-"-l:a ise) if (Oth4;;:Sid.eS&L __FIowCoπUr.oϊ {) -— false) :~iggt>r TX J^stryTifiior. in 20 mssc . b sstid ;) ; free(p)

) ;

static void RXJ.SK (Brioqs *b)

do

{ uintrδ* p - b->neχtB\iS:ferRX i) ; !•: fp ----«■ nx;11) bi^ak; while (i\ot. done :f^;;;ce;. vinq) pf .i. '^■ *- j - get-Ch^c {} ;

} whil- (true) ; Ecsabi slSRs; O ;

File following statistics may be supported by PCXJP:

♦ Number of packets sent;

♦ N umber of packets received;

♦ CRC errors;

♦ Timeouts: and

♦ Buffer unavai lable (ran out of buffers)

PCXϊP may be designed to run in multiple processing environments. Most parameters may be run time configured because it facilitates testing, and any run lime One tuning for performance. Other parameters may be compile time e.g., anything thai alters memory allocation must be done statically at compile time.

The following may be compile time configuration #detlnes that may vary where PCGP is implemented:

♦ # driver bytes: may be two bytes reserved in the common buffer scheme for tlie driver, but this may be a compile time option to accommodate other drivers such as0 RF protocol .

♦ # RX driver buffers: may be tuned to how many buffers would be good for that processor / traffic flow, etc. • # PCGP RX buffers; may be limed to how many buffers woiski be good for that processor / traffic flow, etc.

• Total # of buffers: may be tuned to how many buffers should be at that processor. The CRC may be used to ensure data integrity. If a CRC is invalid, it may not be delivered to the application and the CRC error may be tracked. The message may eventual (y timeout and may be retried by the originator.

Likewise, if the messaging system informs the application that a message was delivered when it was not, this may be a hazard to the system. The Stop Bolus Command is an example of such a command. This may be mitigated by the Request/Action sequence of messages which may be required by the application to change therapy. The Controller may receive a matching command from the Pump application to consider the message delivered,

DEKA may provide a reference way of interfacing PCGP into the Nucleus OS system on the ARM 9 (as shown in FIG. 1 K)). As shown in FIG. 1 1 P. the pegpOS.cpp file may instantiate a PtX)P node instance

(Pegp, a Bridge, etc.) and may provide through pegpOS.h a T^" linkable set of function calls that provide a ⁴C language interlace to the C++ code. This may simplify the 'C code as the objects acted upon are implicit.

The following general rules may be applied: * PCGP may run on all nodes: any driver may support a generic driver interface.

• Race conditions may not be permitted.

• May support half duplex on the SPI port between slave processor and master processor.

• Data transfer may not be attempted; as it either succeeds or returns fail/false. • May require low overhead (time, processing, bandwidth wasted).

• May support CC2510 operating at DMA (fast) SPI clock rates.

SPl flow control may prevent data from being sent if the receiving side does not currently have a.n empty buffer to place the packet. This may be accomplished by asking for permission to send and waiting for a response indicating that you have been cleared to do so. There may also be a way to tell the other side that there are currently no free butters and the transfer should be attempted at a later time.

All transmission may begin with a length byte that indicates the number of bytes to be sent, not including the length byte itself. Following the length may be a single byte indicating the command being; sent. The actual transmission of a packet may be the length of packet plus one for the command byte, followed by the command byte for a message appended and finally the packet itself.

In addition to the command bytes that will be sent, an additional hardware Hue called the FlowC'ontrol line may be added to the traditional four SPI signals. The purpose of this line is to allow the protocol to run as quickly as possible without a need for preset delays, it also allows the slave processor to tell the master processor that it has a packet waiting to be sent, thus eliminating the need for the master processor to poll the slave processor for status.

The following exemplary command values may be used: Commands to be sent- by the mas ter processor ;

Commands to foe seat by the slave processor;

As Hlustraϊed in PIG. I I Q, when the slave processor has a packet to send to the master processor, the slave processor .may notify the master processor (by asserting the FiowContrαl line) thai it has a pending packet that is waiting to be sent. Doing so may result in an IRQ on the master processor at which time the master processor may decide when to go retrieve file message from the slave processor. Retrieving the packet may be delayed at the discretion of the master processor, and the master processor may even decide to attempt to send a packet to the slave processor before retrieving from the slave processor.

The master processor may begin the retrieval by sending the slave processor M CTS commands; this shall be repeated until the slave processor responds by sending the SJVf S G__A PPENDED command along with the packet itself. The Fϊow€ontrol Sine may be cleared after the packet has been sent. If a M CTS command is received by the slave processor when one is not expected, the SVIJTTS command may be ignored. As illustrated m FlG. I IR₁ when the master processor lias a packet to send to the slave processor, the master processor may initiate the- transfer by sending a MJRTS command. Upon receiving the M RTS command, if the slave processor currently has a send packet pending, the slave processor will Sower the FlowControl line so that it may be re-used as a Cleared To Send signal. The slave processor may then tell the master processor thai it is in the process of preparing the SPi DMA to receive the packet, during which time the master processor may stop clocking bytes onto the bus and may allow the slave processor to finish preparing for the receive.

The slave processor may then indicate it is ready to receive the full packet by raising the FlowControl line (which is now used as the CTS signal). Upon receiving the CIS signal the master processor may proceed to send the M_MSG_APPENDED command along with ihe packet itself.

After the completion of the transfer, the slave processor may lower the FlowControl line. If a packet was pending ai the start of the transfer, or a send occurred on the slave processor when the packet was being received, the slave processor may reassert the FlowComrol line now indicating that it has a pending packet.

Referring again to FlG. 1 I A, infusion pump assembly H)O, 100' may include switch assembly 318 coupled to electrical control assembly I 10 (FIG, 3} that may allow a user (not shown) to perform ai least one, and in some embodiments, a plurality of tasks. One illustrative example of such a task is the administration of a bolus close of the infusible fluid (e.g., insulin) without the use of a display assembly. Remote control assembly 300 may allow the user to enable / disable / configure infusion pump assembly 100, 100" to administer the bolus dose of insulin.

Referring also to FiG. 12A, slider assembly 306 may be configured, at least in part, to enable the user to manipulate the menu-based information rendered on display assembly 302. An example of slider assembly 306 may include a capacitive slider assembly, which may be implemented using a CY8C21434-24LFXI PSOC offered by Cypress Semiconductor of San Jose, California, ihe design an operation of which are described within the "C-SD User Module" published by Cypress Semiconductor. For example, via slider assembly 306, the user may slide their finger in the direction of arrow 314, resulting in the highlighted portion of the information included within main menu 350 (shown in HG. \ 2A) rendered on display assembly 302 scrolling upward. Alternatively, the user may slide their finger in the direction of arrow 316, resulting in the highlighted portion of the information included within main menu 350 rendered on display assembly 302 scrolling downward.

Slider assembly 306 may be configured so thai the rate at which e.g. the highlighted portion of main menu 350 scrolls '^"upward^1* or ''downward" varies depending upon the displacement of the finger of the user with respect to point of origin 320. Therefore, if the user wishes lo quickly scroll "upward'^", the user may position their finger near the top of slider assembly 306. Likewise, if the user wishes to quickly scroll "downward", the user may position their finger near the bottom of slider assembly 306. Additionally, if the user wishes Ki slowly scroll "upward", the user may position their linger slightly "upward" with respect to point of origin 320 Further, if the user wishes to slowly scroll "downward", the user may position their linger slightly "downward" with respect to point of origin 320. Once tiie appropriate menu item is highlighted, the user may select the highlighted menu item via one or more switch assemblies 308, 310.

Referring also to FΪGS 12B-12F, assume for illustrative purposes that infusion pump assembly 100, 100' is an insulin pump and the user wishes to configure infusion pump assembly 100, 1 (Kf so that when switch assembly 3 S 8 is depressed by the user, a 0.20 unit bolus dose of insulin is administered. Accordingly, the user may use slider assembly 306 to highlight "Bolus" within main menu 350 rendered on display assembly 302. The user may then use switch assembly 308 io select "Bolus". Once selected, processing logic (not shown) within remote control assembly 300 may then render submenu 352 on display assembly 302 {as shown in FiG. 12B).

The user may then use slider assembly 306 to highlight "Manual Bolus^*' within submenu 352, which may be selected using switch assembly 3CKS. Processing logic (not shown) within remote control assembly 300 may then render .submenu 354 on display assembly 302 {as shown in RG. 12C).

The user may then use slider assembly 306 to highlight "Bolus: 0.0 Units'" within submenu 354, which may be selected using switch assembly 308, Processing logic (not shown) within remote control assembly 300 may then render submenu 356 on display assembly 302 {as shown in FIG. 121». The user may then use slider assembly 306 to adjust the "Bolus^""^' insulin amount to

"0.20 units", which may be selected using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then render submenu 35B on display assembly 302 {as shown in PIG. 12H). The user 14 may then use slider assembly 306 to highlight "Confirm", which may be selected using switch assembly 308, Processing logic (not shown) within remote control assembly 300 may then generate the appropriate signals that may be sent to the above- described telemetry circuitry (not shown) included within remote- control assembly 300. The telemetry circuitry (not shown} included within the remote control assembly may then transmit, via wireless communication channel 3 S 2 established between remote control assembly 300 and infusion pump assembly 100', the appropriate configuration commands to configure infusion pump assembly 100' so that whenever switch assembly 318 is depressed by the user, a 0.20 unit bolus dose of insulin is administered. Once the appropriate commands are successfully transmitted, processing logic {not shown) within remote control assembly 300 may once again render submenu 350 on display assembly 302 (as shown in HG. 12F).

Specifically and once programmed via remote control assembly 300, the user may depress switch assembly 318 of infusion pump assembly 100' to administer the above- described 0.20 unit bolus dose of insulin. Via the above-described memiing system included within remote control assembly 300, the user may define a quantity of insulin to be administered each lime that the user depresses switch assembly 31 S. While this particular example specifies that a single depression of switch assembly 3 IS is equivalent to 0.20 units of insulin, this is for illustrative purposes only and is not intended to be a limitation of this disclosure, as other values (e.g. 1.00 units of insulin per depression) are equally applicable. Assume for illustrative purposes that the user wishes to administer a 2.01) unit bolus dose of insulin. To activate the abovc-dcscribc bolus dose administration system, the user may be required 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 thai infusion pump assembly 100, 100' is ready to administer a bolus does of insulin via switch assembly 318. Accordingly, the user may depress switch assembly 318 ten times (i.e., 2.00 units is ten 0.20 unit doses). After each time that switch assembly 318 is depressed, infusion pump assembly 100, 100' may provide on audible response to the user via an interna! speaker / sound generation device (not shown). Accordingly, the user may depress switch assembly 318 the first time and infusion pump assembly 100, 100^' may generate a confirmation beep in response, thus indicating to the user that infusion pump assembly 100, 100' received the command for (in this particular example) 0.20 units of insulin. As the desired bolus dose is 2,00 units of .insulin, the user may repeat this procedure nine more times in order to effectuate a bolus dose of 2.00 units, wherein infusion pump assembly 100, 100' generates a confirmation beep after each depression of switch assembly 318.

While in this particular example, infusion pump assemblies 100, IiW are described as providing one beep after each time the user depresses switch assembly 318, this is for illustrative purposes only and is not intended to be a limitation of this disclosure. Specifically, infusion pump assembly 100, 100' may be configured to provide a single lyecp for each defined quantity of insulin. As discussed above, a single depression of switch assembly 318 may be equivalent to 0.20 units of insulin. Accordingly, infusion pump assembly 100, 100^* may be configured to provide a single beep for each 0.10 units of insulin. Accordingly, if infusion pump assembly 100, 100' is configured such that a single depression of switch assembly 318 is equivalent to 0.20 units of insulin, each time switch assembly 3 ! 8 is depressed, infusion pump assembly i 00, 100^" may provide the user with two beeps (i.e. one for each 0.10 units of insulin). Once the user lias depressed switch assembly 318 on infusion pump assembly 100" a total often times, the user may simply wait for infusion pump assembly 100, 100' to acknowledge receipt of the instructions to administer a 2.CK) unit bolus dose of insulin {as opposed to the confirmation beep received at each depression of switch assembly 3 i 8). Once a defined period of time (e.g., two seconds) passes, infusion pump assembly 100. 100" may provide an audible confirmation to the user concerning the quantity of units to be administered via ihe bolus insulin dose that the user just requested. For example, as (in ihis example} infusion pump assembly 100, 100' was programmed by the user so that a single depression of switch assembly 318 Ls equivalent to 0.20 units of insulin, infusion pump assembly 100, ! 00' may beep ten times {i.e., 2.00 units is ten 0.20 unit doses). When providing feedback to the user concerning die quantity of units to be administered via the bolus insulin dose, infusion pump assembly K)O, 100' may provide a multi frequency audϊhϊe confirmation. For example and continuing with the above-slated example in which ten beeps are to be provided to the user, infusion pump assembly 100. 100' may group the beeps into groups of five (to facilitate easier counting by the user) and the beeps within each group of five may be rendered by infusion pump assembly 100, 100' so that each subsequent beep has a higher frequency than the preceding beep (in a manner similar to a musical scale). Accordingly ami continuing with the above-stated example, infusion pump assembly 100. 100' may render a 1 ,000 Ik beep, followed by an 1, 100 H?. beep, followed by a 1,200 S fz beep, followed by a 1,300 i\τ beep, followed by a 1,400 Bz heep (thus completing a group of live beeps), followed by a short pause, and then a 1 ,000 Hz beep, followed by an i , 100 Hz beep, followed by a 1 ,200 H?. beep- followed by a 1 ,300 Hz beep, followed by a 1,400 Hz beep (thus completing the second group of five beeps). According to various additional / alternative embodiments the rauifi frequency audible confirmation may utilize various numbers of tones incrementing in frequency. For example, an embodiment may utilize twenty different tones incrementing in frequency. However, the number of tones should not be construed as a limitation of the present disclosure as number of tones may vary according to design criteria and user need, Once infusion pump assembly 100, ! 00' completes the rendering of the muStiireqtieney audible confirmation (i.e, the ten beeps described above), the user may, within a defined period of time (e.g. two seconds), depress switch assembly 318 to provide a confirmation signal to infusion pump assembly 100, 100\ indicating that the multi frequency audible confirmation was accurate and indicative of the size of the bolus dose of insulin to be administered {i.e. 2.00 units K Upon receiving this confirmation signal, infusion pump assembly 100, 100' may render a "confirmation received" audible lone and effectuate the delivery of (in this particular example) the 2.00 unit bolus dose of insulin. In the event that infusion pump assembly 100, 100' fails to receive the above-described confirmation signal infusion pump assembly 100, 100' may render a "confirmation failed" audible tone and will not effectuate the delivery of the bolus dose of insulin. Accordingly, if the multifreqυencv audible confirmation was not accurate / indicative of the size of the bolus dose of insulin to be administered, the user may simply not provide the above- described confirmation signal, thereby canceling the delivery of the bolus dose of insulin. As discussed above, in one exemplary embodiment of the above-described infusion pump assembly, infusion pump assembly 100' may be used to communicate with a remote control assembly 300, When such a remote control assembly 300 is utilized, infusion pump assembly ! 00^' and remote control assembly 300 may routinely contact each other to ensure thai the two devices are still in communication with each other. For example, infusion pump assembly K⁾O^' may "ping" remote control assembly 300 to ensure that remote control assembly 300 is present and active. Further, remote control assembly 300 may ""ping" infusion pump assembly 100^* to ensure that infusion pump assembly 100' is still present and active. In the event that one of infusion pump assembly 100" and remote control assembly 300 fails to establish communication with the other assembly, the assembly that is unable to establish communication may sound a "separation" alarm. For example, assume that remote control assembly 300 is left in the car of the user, while infusion pump assembly 100' is in ihe pockel of the user. Accordingly and after a defined period of time, infusion pump assembly 100^" may begin sounding the "separation" alarm, indicating that communication with remote control assembly 300 cannot be established. Using switch assembly 318, the user may acknowledge / silence this "separation" alarm.

As the user may define and administer a bolus insulin dose via switch assembly 3 IS of infusion pump assembly S OO" while remote control assembly 300 is not in communication with infusion pump assembly 100^", infusion pump assembly 100" may store information concerning the administered bolus insulin dose within a log file {nol shown) stored within infusion pump assembly 100\ This log file (not shown) may be stored within nonvolatile memory (not shown) included within infusion pump assembly 100'. Upon communication being reestablished between infusion pump assembly 100' and remote control assembly 300, infusion pump assembly 100' may provide the information concerning the administered bolus insulin dose stored within the log file (not shown) of infusion pump assembly 100' to remote control assembly 300.

Further, if the user anticipates separating remote control assembly 300 from infusion pump assembly 100^", the user {via the above-described menuiπg system) may configure infusion pump assembly 100' and remote control assembly 300 to be in '"separation^"' mode, thus eliminating the occurrence of the above-described "separation" alarms. However, the devices may continue to ^v'ρing" each other so that when they come back into communication with each other, infusion pump assembly 100' and remote control assembly 300 may automatically exit "separation" mode.

Further, if the user anticipates traveling in an airplane, the user (via the above- described rnenuing 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 suspend 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. Switch assembly 318 may be used to perform additional functions, such as: checking the batten' life of reusable housing assembly 102; pairing reusable housing assembly 102 with remote control assembly 300; and aborting the administration of a bolus does of infusible fluid. Checking Battery Life; Reusable housing assembly 102 may include a rechargeable battery assembly that may be capable of powering infusion pump assembly 100, U)⁽T for approximately three days (when fully charged). Such a rechargeable battery assembly may have a usable life of a predetermined number of usable hours, for example, or years, or other predetermined length of usage. However, the predetermined IiIV may depend on many factors, including but not limited to, one or more of the following: climate, daily usage, and number of recharges. Whenever reusable housing assembly 102 is disconnected from disposable housing assembly 1 14. infusion pump assembly 100, 100" may perform a battery cheek on the above-described rechargeable batten' assembly whenever switch assembly 318 is depressed for a defined period of time (e.g. in excess of two seconds). In the event that the above-described rechargeable battery assembly is determined to be charged above a desired threshold, infusion pump assembly 100, KiO' may render a "battery pass" tone. Alternatively, in the event that the above-described rechargeable battery assembly is determined to be charged below a desired threshold, infusion pump assembly 100, 100' may render a "battery Fail" 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 1 14.

Fairing: As discussed above and in one exemplary embodiment of the above- described infusion pump assembly, infusion pump assembly 100' may be used to communicate with remote control assembly 300. In order to effectuate communication between infusion pump assembly 1 OCr and remote control assembly 300, a paring process may be performed. During such a pairing process, one or more infusion pump assemblies (e.g. infusion, pump assembly 100^T) 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 iOϋ'K Specifically, the serial numbers of the infusion pump assemblies (e.g. infusion pump assembly ! 00^') may be recorded within a pairing file (not shown) included within remote control assembly 300 and the serial number of remote control assembly 300 may be recorded within a pairing file (not shown) included within the infusion pump assemblies (e.g. infusion pump assembly 100^'}.

According to an embodiment, in order to effectuate such a pairing procedure, the user may simultaneously hold down one or more switch assemblies on both remote control assembly 300 and infusion pump assembly 1OO\ For example, the user may simultaneously hold down switch assembly 3 K⁾ included within remote control assembly 300 and switch assembly 318 included within infusion pump assembly 100' for a defined period exceeding e.g. fwQ seconds. Once this defined period is readied, one or more of remote control assembly 300 and in fusion pump assembly 100' may generate an audible signal indicating that the above-described pairing procedure has been effectuated.

According to another embodiment, prior to performing the pairing process, the user may uncouple reusable housing assembly S 02 from disposable housing assembly 1 14, By requiring this initial step, further assurance is provided thai an infusion pump assembly being worn by a user may not be surreptitiously paired with a remote control assembly, Once uncoupled, 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 above-described menuing system in combination with e.g., switch assembly 310. The user may be prompted on display assembly 302 of remote control assembly 300 Io depress and hold switch assembly 318 on infusion pump assembly 100'. Additionally, remote control assembly 304 may switch to a low power mode to e.g., avoid trying to pair with distant infusion pump assemblies. The user may then depress and hold switch assembly 318 on infusion pump assembly 100' so that infusion pump assembly 100' enters a receive mode and waits for a pairing command from remote control assembly 300. Remote control assembly 300 may then transmit a pairing request, to infusion pump assembly 100', which may be acknowledged by infusion pump assembly 100'. Infusion pump assembly 100' may perform a security check on the pairing request received from remote control assembly 300 and (if the security check passes) infusion pump assembly 100' may activate a pump pairing signal (i.e., enter active pairing mode). Remote control assembly 300 may perform a security cheek on the acknowledgment received from infusion pu mp assembly 100'.

The acknowledgment received from infusion pump assembly HM)' may define the serial number of infusion pump assembly 100^* and remote control assembly 300 may display that serial number on display assembly 302 of remote control assembly 300, The user may be asked if they wish to pair with the pump found. 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 depress and hold switch assembly 318 on infusion pump assembly 100'. The user may then depress and hold switch assembly 318 on infusion pump assembly U⁾O¹ and depress and hold e.g. switch assembly 310 on remote control assembly 300.

Remote control assembly 300 may confirm thai remote switch assembly 310 was 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 the integrity of same. If the integrity of the confirmation received is not verified, the pairing process is aborted. If the integrity of the confirmation received is verified, any existing remote pair configuration file is overwritten to reflect newly-paired remote control assembly 300, the pump pairing completed signal is activated, and the pairing process is completed.

Additionally, infusion pump assembly 100' may confirm that switch assembly 318 was 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 KK⁾' to confirm the integrity of same. If the integrity of the confirmation received is not verified, the pairing process is aborted. If the integrity of the confirmation received is verified, a pair list HIe within remote control assembly 300 may be modified to add infusion pump assembly 100'. Typically, remote control assembly 300 may be capable of pairing with multiple infusion pump assemblies, while infusion pump assembly 100" may be capable of only pairing with a single remote control assembly. The pairing completed signal may be activated and the pairing process may be completed.

When the pairing process is completed, one or more of remote control assembly 300 and infusion pump assembly 100" may generate an audible signal indicating that the above- described pairing procedure has been successfully effectuated, Aborting Bolus Dose: in the event that the user wishes to cancel a bolus dose of e.g. insulin being administered by infusion pump assembly iOO\ the user may depress switch assembly 318 (e.g., shown in FIGS. I & 2) for a defined period exceeding e.g. five seconds. Once this defined period is reached, infusion pump assembly KK)' may render an audible signal indicating that the above-described cancellation procedure has been effectuated. While switch assembly 318 is shown as being positioned on the top of infusion pump assembly 100, 100^*. this is for illustrative purposes only and is not intended to be a Limitation of this disclosure, as other configurations are possible. For example, switch assembly 318 may be positioned about the periphery of infusion pump assembly KKX 100'. Referring also to FIGS. ! 3-15, there is shown an alternative-embodiment infusion pump assembly 400. As with pump assembly 100, 100', infusion pump assembly 400 may include reusable housing assembly 402 and disposable housing assembly 404. in a fashion similar to reusable housing assembly 102, reusable housing assembly 402 may include a mechanical control assembly (that includes at least (me pump assembly and at ⁽east one valve assembly). Reusable housing assembly 402 may also include an electrical control assembly that is configured to provide control signals to the mechanical control assembly and effectuate the delivery of an infusible fluid to a user. The valve assembly may be configured to control the How of the infusible fiuid through a fluid path and the pump assembly may be configured to pump the infusible fluid from the fluid path to the user in a fashion similar to disposable housing assembly 1 14, disposable housing assembly 404 may be configured for a single use or for use for a specified period of time, e.g., e.g., three days or any oihcr amount of time. Disposable housing assembly 404 may be configured such, that any components in infusion pump assembly 400 that come in contact with the infusible fluid are disposed on and/or within disposable housing assembly 404.

In this particular embodiment of the infusion pump assembly, infusion pump assembly 400 may include switch assembly 406 positioned about the periphery of infusion pump assembly 400. For example, switch assembly 406 may be positioned along a radial edge of infusion pump assembly 400, which may allow for easier use by a user. Switch assembly 406 may be covered with a waterproof membrane configured to prevent ihe infiltration of water into infusion pump assembly 400. Reusable housing assembly 402 may include main body portion 408 (housing the above-described mechanical and electrical control assemblies) and locking ring assembly 410 that may be configured to rotate about main body portion 4OB (in the direction of arrow 412), in a fashion similar to reusable housing assembly 102 and disposable housing assembly 1 14, reusable housing assembly 402 may be configured to releasably engage disposable housing assembly 404. Such reϊeasable engagement may be accomplished by a screw-on, a twist-lock or a compression in configuration, for example, Sn an embodiment in which a twisi-lock configuration is utilised, the user of infusion pump assembly 400 may- first properly position reusable housing assembly 402 with respect to disposable housing assembly 404 and may then rotate locking ring assembly 410 (in the direction of arrow 412} to releasahiy engage reusable bousing assembly 402 with disposable housing assembly 404. Through the use of Socking ring assembly 410, reusable housing assembly 402 may he properiy positioned with respect to disposable housing assembly 404 and then reSeasably engaged by rotating locking ring assembly 410, thus eliminating the need to rotate reusable housing assembly 402 with respect to disposable housing assembly 404, Accordingly, reusable housing assembly 402 may be properly aligned with disposable housing assembly 404 prior to engagement, and such alignment may not be disturbed during the engagement process. Locking ring assembly 410 may include a latching mechanism (not shown) that may prevent the rotation of locking ring assembly 410 until reusable housing assembly 402 and disposable housing assembly 404 are properly positioned with respect to each other. Referring also to FIGS. ] 6-1 S, there is shown an alternative-embodiment infusion pump assembly 500. Af, with pump assembly 100, 100\ infusion pump assembly 500 may include reusable bousing assembly 502 and disposable housing assembly 504.

In a fashion similar to reusable housing assembly 402, reusable housing assembly 502 may include a mechanical control assembly (that, includes at least one pump assembly and at least one valve assembly). Reusable housing assembly 502 may also include an electrical control assembly that is configured to provide control signals to the mechanical control assembly and effectuate the delivery of an infusible fluid, to a user. The valve assembly may be configured to control the flow of the infusible fluid through a fluid path and the pump assembly may be configured to pump the infusible fluid from the fluid path to the user.

Sn a fashion similar to disposable housing assembly 404, disposable housing assembly 504 may be configured for a single use or for use for a specified period of time, e.g., e.g., three days or any other amount of time. Disposable housing assembly 504 may be configured such, that any components in infusion pump assembly 500 that come in contact with the infusible fluid are disposed on and/or within disposable housing assembly 504. in this particular embodiment of the infusion pump assembly, in fusion pump assembly 500 may include switch assembly 506 positioned about the periphery of infusion pump assembly 500. For example, switch assembly 506 may be positioned along a radial edge of infusion pump assembly 500, which may allow for easier use by a user. Switch assembly 506 may be covered with a waterproof membrane and/or an o-ring or other sealing mechanism may be included on the stem 507 of the switch assembly 506 configured to prevent the infiltration of water into infusion pump assembly S00. However, io some embodiments, switch assembly 506 may include an overniolded rubber button, thus providing functionality as a waterproof seal without the use of a waterproof membrane or an o-ring. However, to still other embodiments, the overmolded rubber button may additionally be covered by a waterproof membrane and/or include an o-ring. Reusable housing assembly 502 may include main body portion 508 (housing the above-described mechanical and electrical control assemblies) and locking ring assembly 510 that may be configured to rotate about main body portion 508 (in the direction of arrow 512).

In a fashion similar to reusable housing assembly 402 and disposable housing assembly 404, reusable housing assembly 502 may be configured to rdeasably engage disposable housing assembly 504. Such reieasable engagement may be accomplished by a screw-on, a twist-lock or a compression fit configuration, for example. In an embodiment in which a twist-lock configuration is utilized, the user of infusion pump assembly 500 may first properly position reusable housing assembly 502 with respect to disposable housing assembly 504 and may then rotate locking ring assembly 510 (in the direction of arrow 512} to releasabϊy engage reusable housing assembly 502 with disposable housing assembly 404. As locking ring assembly 510 included within infusion pump assembly 500 may be taller (i.e., as indicated by arrow 514) than locking ring assembly 410, locking ring assembly 510 may include a passage 516 through which button 506 may pass. Accordingly, when assembling reusable housing assembly 502, locking ring assembly 510 may be installed onto main body portion 50S (in the direction of arrow 5 18). Once Socking ring assembly 510 is installed onto main body portion 508, one or more locking tabs (not shown) may prevent Socking ring assembly 510 from being removed from main body portion 508. The portion of switch assembly 506 that protrudes through passage 516 may then be pressed into main body portion 508 (in the direction of arrow 520), thus completing the installation of switch assembly 506, Although button 506 is shown in various locations on infusion pump assembly 500, button 506, in other embodiments, may be located anywhere desirable on infusion pump assembly 500.

Through the use of locking ring assembly 510, reusable housing assembly 502 maybe properly positioned with respect to disposable housing assembly 50-4 and then reieasably engaged by rotating locking ring assembly 510. thus eliminating the need to rotate reusable housing assembly 502 with respect to disposable housing assembly 504. Accordingly, reusable housing assembly 502 may be properly aligned with disposable housing assembly 504 prior to engagement, and such alignment may not be disturbed during the engagement process. Locking ring assembly 510 may include a latching mechanism (not shown) that prevents the rotation of locking ring assembly 510 until reusable housing assembly 502 and disposable housing assembly 504 are properly positioned with respect to each other. Passage 516 way be elongated to allow for the movement of locking ring 510 about switch assembly 506.

Referring also to FIGS. 19A-I9B & 20-2 K there are shown various views of infusion pump assembly 5CKl which is shown to include reusable housing assembly 502, switch assembly 506, and main body portion 508. As discussed above, main body portion 508 may include a plurality 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 enhance clarity, printed circuit board 600 has been removed from FIG. U⁾B to allow for viewing of the various components positioned beneath printed circuit board 600.

The various electrical components that may be electrically coupled with printed circuit board 600 may utilize spring-biased terminals that allow for electrical coupling without tlie need for soldering die connections. For example, vibration motor assembly 602 may utilize a pair of spring-biased terminals (one positive terminal and one negative terminal ) that are configured to press against corresponding conductive pads on printed circuit board 600 when vibration motor assembly 602 is positioned on printed circuit board 600. However, in the exemplary embodiment, vibration motor assembly 602 is soldered directly to the printed circuit board.

As discussed above, volume sensor assembly !48 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. 5,575,3 tO and 5,755,683 assigned to DEKA Products Limited Partnership, as well as the U.S. patent application Publication Nos. US 2007/022807! A l , US 2007/0219496 Λl, US 2007/0219480 A L US 2007/0219597 A K the entire disclosures of all of which are incorporated herein by reference.

Vibration motor assembly 602 may be configured to provide a vibration-based signal to the user of infusion pump assembly 500. For example, in the event that the voltage of battery 606 (which powers infusion pump assembly 500) is below the minimum acceptable voltage, vibration motor assembly 602 may vibrate infusion pump assembly 500 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 above-described shape memory actuator (e.g. shape memory actuator 1 12), As discussed above, shape memory actuator S 12 may be, for example, a conductive shape-memory alloy wire that changes shape with temperature. The temperature of shape-memory actuator 1 S 2 may be changed with a heater, or more conveniently, by application of etectricai energy. Accordingly, one- end of shape memory actuator 1 12 may be rigidly affixed (i.e., anchored) to shape memory actuator anchor 604 and the other end of shape memory actuator 1 12 may be applied to e.g. a valve assembly and/or a pump actuator. Therefore, by applying electrical energy to shape memory actuator S 12. the length of shape memory actuator 1 12 may be controlled and, therefore, the valve assembly and/or the pump actuator to which it is attached may be manipulated.

Antenna assembly 608 may be configured to allow for wireless communication between e.g. infusion pump assembly 5(K) and remote control assembly 300 CFKJ. 1 i ). As discussed above, remote control assembly 300 may allow the user to program infusion pump assembly 500 and e.g. configure bolus infusion events. As discussed above, infusion pump assembly 500 may include one or more valve assemblies configured to control the flow of the infusible fluid through a fluid path (within infusion pump assembly 500) and 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 to include three valve assemblies, namely measurement valve assembly 610, volume sensor valve assembly 612, and reservoir valve assembly 614.

As discussed above and referring also to FlG. 2 L the infusible fluid may be stored within reservoir 1 18. In order to effectuate the delivery of the infusible fluid to the user, the processing logic (not shown) included within infusion pump assembly 500 may energize shape memory actuator 1 12, which may be anchored on one end using shape memory actuator anchor 604. Referring also to FIG. 22 A, shape memory actuator i 12 may result in the 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 the activation of reservoir valve assembly 614 may result in the downward displacement of reservoir valve actuator 614A and the closing of reservoir valve 614B, resulting in the effective isolation of reservoir 118. Further, pump assembly 106 may include pump plunger 106 A and pυrap chamber 106B and the activation of pump assembly 106 may result in pump plunger I06A being displaced in a downward fashion into pump chamber I06B and the displacement of the infusible fluid (in the direction of arrow 616),

Voiurae senses valve assembly 612 may include volume sensor valve actuator 6S2A and volume sensor valve 612B. Referring also to FIG. 22B, volume sensor valve actuator 612A may be closed via a spring assembly tliat provides mechanical force to seal volume sensor valve 612B. However, when pump assembly J 06 is activated, if the displaced infusible fluid is of sufficient pressure to overcome the mechanical sealing force of volume sensor valve assembly 612, (he displacement of the infusible fluid occurs in the direction of arrow 618. This may result in the filling of volume sensor chamber 620 Included within volume sensor assembly 148. Through the use of speaker assembly 622, port assembly 624, reference microphone 626, spring diaphragm 628. invariable volume microphone 630, volume sensor assembly 14S may determine the volume of infusible fluid included within volume sensor chamber 620. Referring also to FlG. 22C once the volume of infusible fluid included within volume sensor chamber 620 is calculated, shape memory actuator 632 may be energized, resulting in the activation of measurement valve assembly 610, which may include measurement valve actuator 6 S OA and measurement valve 6 S OB. Once activated and due to the mechanical energy asserted on 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 body of the user.

Referring also to FiG. 23, there is shown an exploded view of infusion pump assembly 500. Shape memory actuator 632 may be anchored (on a first tnύ) 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, whieh may activate measurement valve assembly 610. Volume sensor assembly spring retainer 642 may properly position volume sensor assembly 148 with respect to the various other components of infusion pump assembly 500. Valve assembly 638 may be ustύ in conjunction with shape memory actuator 1 12 to activate pump plunger 106A. Measurement valve 61 OB, volume sensor valve 612B and/or reservoir valve 614B may be self-contained valves that are configured to allow for installation during assembly of infusion pump assembly 500 by pressing the valves upward into the lower surface of main body portion 508. Referring also to FlG. 24 & FJGS. 25A-25D, there is shown a more-detailed view of pump assembly 106. Pump actuator assembly 644 may include pump actuator support structure 646, bias spring 648, and lever assembly 650.

Referring also to FIGS. 26A-26B & FIGS. 27A-27B, there is shown a more-detailed view of measurement valve assembly 610. As discussed above, valve assembly 638 may activate measurement valve assembly 610.

Referring also to FfGS. 28A-28D, infusion pump assembly 500 may include measurement valve assembly 6S O. As discussed above, valve assembly 638 may be activated via shape memory actuaiαr 632 and actuator assembly 640, Accordingly, to infuse the quantity of infusible fluid stored within volume sensor chamber 620, shape memory actuator 632 may need to activate valve assembly 638 for a considerable period of time (e.g. one minute oτ more), As ihis would consume a considerable amount of power from battery 606, measurement valve assembly 610 may allow for the temporary activation of valve assembly 638, at which point measurement valve latch 656 may prevent valve assembly 638 from returning to its non-activated position. Shape memory actuator 652 may be anchored on a first end using electrical contact 654. The other end of shape memory actuator 652 may be connected to a valve iaich 656. When shape memory actuator 652 is activated, shape memory actuator 652 may pull valve latch 656 forward and release valve assembly 638. As such, measurement valve assembly 610 may be activated via shape memory actuator 632. Once measurement valve assembly 6S O has been activated, valve latch 656 may automatically latch valve assembly 638 in the activated position. Actuating shape memory actuator 652 may pu!l valve latch 656 forward and release valve assembly 638. Assuming shape memory actuator 632 is no longer activated, measurement valve assembly 610 may move to a de-activated state once valve latch 656 has released valve assembly 638, Accordingly, through the use of measurement valve assembly 610, shape memory actuator 632 does not nccύ to be activated during the entire time that it takes to infuse the quantity of infusible fluid stored within volume sensor chamber 620,

As discussed above, the above-described infusion pump assemblies (e.g., infusion pumps assemblies 100, 100', 400, 500) may include an external infusion set 134 configured to deliver the infusible fluid to a user. External infusion set 134 may include a cannula assembly S 36, which may include a needle or a disposable cannula 138, and tubing assembly 140. Tubing assembly 140 may be in fluid communication with reservoir 1 18, for example, by way of the fluid path, and with cannula assembly 138 for example, either directly or by way of a cannula interface 142.

Referring also to FiG. 29. there is shown an alternative embodiment infusion pump assembly 700 that is configured to store a portion of tubing assembly 140. Specifically, infusion pump assembly 700 may include peripheral tubing storage assembly 702 that is configured to allow the user to wind a portion of tubing assembly 140 about the periphery of infusion pump assembly 700 (in a manner similar to that of a yoyo). Peripheral tubing storage assembly 702 may be positioned about the periphery of infusion pump assembly 700, Peripheral tubing storage assembly 702 may be configured as an open trough into which a portion of tubing assembly 140 maybe wound. Alternatively, peripheral tubing storage assembly 702 may include one or more divider portions 704. 706 that form a plurality of narrower troughs that may be sized to generate an interference fit between the walls of the narrower trough and the exterior surface of the portion of tubing 140. When peripheral tubing storage assembly 705 includes plurality of divider portions 704, 706. the resulting narrower troughs may be wound in a spiral fashion about the periphery of infusion pump assembly 700 (in a manner similar to the thread of a screw).

Referring also to FKlS. 30-3 L there is shown an alternative embodiment infusion pump assembly 750 that is configured to store a portion of tubing assembly 140. Specifically, infusion pump assembly 750 may include peripheral tubing storage assembly 752 that is configured to allow the user to wind a portion of tubing assembly 140 about the periphery of infusion pump assembly 750 (again, in a manner similar to that of a yoyo). Peripheral tubing storage assembly 752 may be positioned about the periphery of infusion pump assembly 750. Peripheral tubing storage assembly 752 may be configured as an open trough into which a portion of tubing assembly 140 is wound. Alternatively, peripheral tubing storage assembly 752 may include one or more divider portions 754, 756 that form a plurality of narrower troughs that may be sized Io generate an interference fit between the walls of the narrower trough and the exterior surface of the portion of tubing 140. When peripheral tubing storage assembly 752 includes plurality of divider portions 754, 756, the resulting narrower trough may be wound in a spiral fashion about the periphery of infusion pump assembly 750 (again, in a manner similar to the thread of a screw).

Infusion pump assembly 750 may include tubing retainer assembly 758. Tubing retainer assembly 758 may be configured to rekasabiy secure tubing assembly 140 so as to prevent tubing assembly S 40 from unraveling from around infusion pump assembly 750. Sn cme embodiment of tubing retainer assembly 758, tubing retainer assembly 758 may include downward facing pin assembly 760 positioned above upward facing pin assembly 762. The combination of pin assemblies 760, 762 may define a "pinch point" through which tubing assembly 140 may be pushed. Accordingly, the user may wrap tubing assembly 140 around the periphery of infusion pump assembly 750, wherein each loop of tubing assembly 140 is secured within peripheral tubing storage assembly 752 via tubing retainer assembly 758. Sn the event that the user wishes to lengthen the unsecured portion of tubing assembly 140, the user may release one loop of tubing assembly 140 from tubing retainer assembly 758. Conversely, in the event thai the user wishes to shorten the unsecured portion of tubing assembly 140, the user may secure one additional loop of tubing assembly 140 within tubing retainer assembly 758.

Referring also to F IGS. 32-33. there is shown an exemplary embodiment of infusion pump assembly 800. As with infusion pump assemblies 100, 100', 400, and 500, infusion pump assembly SOO may include reusable housing assembly 802 and disposable housing assembly 804.

With reference also to FIGS, 34A-34B, in a fashion similar to infusion pump assembly 100, reusable housing assembly 802 may be configured to reieasably engage disposable housing assembly 804. Such releasable engagement may be effectuated by a screw-on, twist-lock, or compression fit configuration, for example. Infusion pump assembly 800 may include Socking ring assembly 806. For example, reusable bousing assembly 802 may be properly positioned relative io disposable housing assembly, and locking ring assembly 806 may be rotated to releasable engage reusable housing assembly 802 and disposable housing assembly 804.

Locking ring assembly 806 may include nub 808 that may facilitate rotation of locking ring assembly 806. Additionally, the position of nub 808, e.g., relative to lab 810 of disposable housing assembly 804. may provide verification that reusable housing assembly 802 is fully engaged with disposable housing assembly 804. For example, as shown in FiG. 34Λ, when reusable housing assembly 802 is properly aligned with disposable housing assembly 804, nub 808 may be aligned in a first position relative to tab 810. Upon achieving a fully engaged condition, by rotation locking ring assembly 806. nub 808 may be aligned in a second position relative to tab 810, as shown in FiO. 34B.

Referring also to FIGS, 35 A-35C and MGS. 36-38A, in a fashion similar to reusable housing assembly 102, reusable housing assembly 802 may include mechanical control assembly 812 (e.g., which may include valve assembly 814, shown in RG. 36, including one or more valves and one or more pumps for pumping and controlling the How of the infusible fluid). Reusable housing assembly 802 may also include an electrical control assembly 8 ! 6 that may be configured to provide control signals to the mechanical control assembly 812 Io effectuate the delivery of an infusible fluid to the user. Valve assembly 814 may be configured to control the flow of the infusible fluid through a fluid path and the pump assembly may be configured to pump the infusible fluid from the fluid palh to the user.

Mechanical control assembly 812 and electrical control assembly Sl 6 may be contained within a housing defined by base plate 818, body 820. Sn some embodiments one or more of base plate 8 ! 8 and body 820 may provide electromagnetic shielding. In such an embodiment, the electromagnetic shielding may prevent and/or reduce electromagnetic interference received by electrical control assembly 816 and/or created by electrical control assembly 816. Additionally / alternatively, EMI shield 822 may be included, as shown in FIG. 36 and FlG. 37. HMI shield 822 may provide shielding against generated and/or received electromagnetic interference.

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, or the like) The switch assembly may include button 824 that may be disposed in opening 826 of body 820. As shown, e.g., in FlG. 35B, locking ring assembly 806 may include radial slot 828 that may be configured to allow locking ring assembly 806 Io be rotated relative to body 820 while still providing facile access to button 824.

Referring also to FIGS. 39A-39C, electrical control assembly 816 may include printed circuit board 830 as well as battery 832. Printed circuit board 830 may include the 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 just been dispensed, and determine, based upon the dosage required by the user, whether enough infusible fluid has been dispensed. If not enough infusible fluid has been dispensed, electrical control assembly 816 may determine that more infusible fluid should be pumped. Electrical control assembly 816 may- provide the appropriate signal to mechanical control assembly Si 2 so that any additional necessary dosage may be pumped or electrical control assembly 816 may provide the appropriate signal Io mechanical control assembly 812 so that the additional dosage may be dispensed with the next dosage. Alternatively, if too much infusible fluid has been dispensed, electrical control assembly 816 may provide the appropriate signal to mechanical control assembly 812 so that less infusible fluid may be dispensed in the next dosage, Electrical control assembly 8 16 may include one or more microprocessors:, In an exemplar}' embodiment, electrical control assembly 816 may include three microprocessors. One processor (e.g., which may include, but is not limited Lo a CC251O microcontroller / RF transceiver, available from Chipcon AS, of Oslo, Norway) may be dedicated to radio communication, e.g.. for communicating with a remote control assembly. Two additional microprocessors (example of which may include, but is not limited io an MSP430 microcontroller, available from Texas Instruments Inc. of Dallas, Texas) may be dedicated to issuing and carrying out commands {e.g., to dispense a dosage of infusible fluid, process feedback signals from a volume measurement device, and the like).

As shown in FIG. 35C, base plate 81 S may provide access to electrical contacts 834, e.g., which may be electrically coupled to electrical control assembly 816 for recharging battery 832. Base plate Sl S may include one or more features (e.g., openings 836, 838} which may be configured to facilitate proper alignment with disposable housing assembly 804 by way of cooperating features {e.g., tabs) of disposable housing assembly 804. Additionally, as shown in FIGS. 40A-40C, 41 A-41 B, and 42A-42C, base plate 818 may include various features for mounting valve assembly 814 and electrical control assembly 816, as well as providing access to disposable housing assembly 8(W by valve assembly 814.

Locking ring assembly 806 may include grip inserts 840, 842, e.g., which may include an elastomeric or textured material that may facilitate gripping and twisting locking ring assembly 806, e.g., for engaging / disengaging reusable bousing assembly 802 and disposable housing assembly 804. Additionally, locking ting assembly 806 may include a sensing component {e.g., magnet 844) that may interact with a component of reusable housing assembly 802 (e.g., a Hall Effect sensor), e.g., to provide an indication of the nature 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 of whether reusable housing assembly 802 is properly engaged with the mating component. In the exemplary embodiment, a Hail Effect sensor {not shown! may be located on the pump printed circuit board. The Hall Effect sensor may detect when the locking ring has been rotated to a closed position. Thus, the HaM Effect sensor together with magnet 844 may provide a system for determining whether the locking ring has been rotated to a closed position.

The sensing component (magnet) 844 together with the reusable housing assembly components, i.e., in the exemplary embodiment, the HaSl Effect sensor, may work to provide lor a determination of whether the reusable housing assembly is properly attached to the intended component or device. Locking ring assembly 806 may not turn without being attached to a component; i.e., disposable housing assembly 804» a dust cover or a charger. Thus, the sensing component together with the reusable housing assembly component may function to provide many advantageous safety features to the infusion pump system. ^'These features may include, but are not limited to, one or more of the following. Where the system does not detect being attached to a disposable assembly, a dust cover or a charger, the system may notify, alert or alarm the user as the reusable portion, e.g., the valves and pumping components, may be vulnerable to contamination or destruction which may compromise the integrity of the reusable assembly. Thus, the system may provide for an integrity alarm to alert the user of potential reusable integrity threats. Also, where the system senses the reusable assembly is attached to a dust cover, the system may power off or reduce power to conserve power. This may provide for more efficient use of power where the reusable assembly is not connecting to a component in which it needs to interact. Reusable housing assembly S02 may attach 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 may detect that the locking ring is in the closed position, and therefore, tliat reusable housing assembly 802 is reSeasabiy engaged to a disposable housing assembly, a dust cover, or a battery charger/battery charging station (or, another component}. The infusion pump system may determine the component to which it is attached by using the AVS system described in more detail below or by an electronic contact. Referring now also to FIGS. 38B-38D, one embodiment of a dust cover {e.g., dust cover 839) is shown. Sn the exemplary embodiment, dust cover 839 may include features 84 ! , 843, 845, 847 such that the locking ring of reusable bousing assembly 802 may releasably engage dust cover 839. Iu addition, dust cover 839 may further include recess region 849 for accommodating the vaiving and pumping features of reusable housing assembly 804. For example, with respect to the dust cover, the AVS system may determine that a dust cover, and not a disposable housing assembly, is connected to the reusable housing assembly. The AVS system may distinguish using a look-up table or other comparative data and comparing the measurement data with characteristic dust cover or empty disposable housing assembly data. With respect to the battery charger, the battery charger, in the exemplary embodiments, may include electric contacts. When the reusable housing assembly is attached to the battery charger, the infusion pump assembly electronic system may sense that the contacts have been made, and will thus indicate that the reusable housing assembly is attached to a battery charger.

Referring also to FIGS. 43A-45B and FIGS. 44A-44C an embodiment of valve assembly 814, which may include one or more valves and (me or more pumps, is shown. As with in fusion pump assemblies 100, 100', 400, and 500, valve assembly 814 may generally include reservoir valve 850, plunger pump 852, volume sensor valve 854, and measurement valve SS6. Similar to the previous description, reservoir valve 850 and plunger pump 852 may be actuated by shape memory actuator 858, which may be anchored (on 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 (on a first end) to shape memory actuator anchor 866. In a similar manner as discussed above, measurement valve may be maintained in an open position via measurement valve latch assembly 868. Measurement valve 856 may be released via actuation of shape memory actuator 870, which may be anchored (on a first end) by shape memory actuator anchor 872. In some embodiments, shape memory actuator anchor 860 may be potted onto the reusable housing assembly. Using this process during manufacture ensures shape memory length actuator 858 is installed and maintains the desired length and tension/strain.

Referring also to FIGS. 45A-45B and FSGS. 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 S74 may include bias spring S76 and lever assembly 878. Actuator assembly 874 may actuate both plunger pump 852 and measurement valve 850.

Referring also to FiGS. 47A-47B, measurement valve 856 may be actuated by shape memory¹ actuator 864. via valve actuator 862 and lever assembly 878, Once actuated, measurement valve latch assembly 868 may maintain measurement valve 856 in an open position. Measurement valve latch assembly 868 actuated by shape memory actuator 870 to release measurement valve 856, al lowing it to return to a closed position. Disposable housing assembly 804 may be configured, tor a single use or for use for a specified period of time, e.g., e.g., three days or any other amount of time. Disposable housing assembly SCM may be configured such thai any of the component of infusion pump assembly 800 that come in contact with the infusible fluid may be disposed on and/or within disposable housing assembly 804. As such, the risk of contaminating the infusible fluid may be reduced.

Referring also to PIG. 48 and FIGS. 49A-49C, disposable housing assembly 804 may include base portion 900, membrane assembly 902, and lop portion 9(W. Base portion 900 may include recess 906 thai together with membrane assembly 902 defines reservoir 908 for receiving an infusible fluid (not shown), e.g., insulin. Referring also to FIGS. 50A- 50C, recess 906 may be at least partially formed by and integral with base portion 900. Membrane assembly 902 may be seaiingly engaged with base portion 900, e.g., by being compressiveiy pinched between base portion 900 and top portion 904. ^"fop portion 904 may be attached to base portion 900 by conventional means, such as gluing, heat sealing, ultrasonic welding, and compression fitting. Additional Iy / alternatively, membrane assembly 902 may be attached to base portion 900. e.g., via gluing, ultrasonic welding, heat sea! ing, and the like, io provide a sea! between membrane assembly 902 and base portion 900.

Still referring to FIGS. 48 and 50A₅ recess 906, in the exemplary embodiment, includes raised portion 901 which includes area 903 about fluid openings 905 leading to the fluid line. Raised portion 901 , in the exemplary embodiment, extends about ihe perimeter of recess 906. However, in other embodiments, raised portion 90 ϊ may not extend the entire perimeter, but may be partially about the perimeter. Area 903 about fluid openings 905 may be shaped as shown in the exemplary- embodiment, including an angled portion, which in some embodiments, includes 45 degree angles, however in other embodiments, the angle may be greater or lesser. In some embodiments, the ptrøip may not generate a sufficient enough vacuum to collapse the reservoir so as to eliminate the entire volume of fluid that may be stored in the reservoir. Raised portion 901 may act to minimize wasted fluid. Fluid openings 90S₅ which, in the exemplary embodiment, may include three openings, however, in other embodiments may include more openings or fewer openings. may be surrounded by area 903 of the raised portion. In the exemplary embodiment, Ouki openings 905 may be narrow in the center, thus creating a surface tension that may prevent the air from being drawn into the opening. In the exemplary embodiment, this area may be designed to encourage any air that is present in the reservoir to be drawn above one of fluid openings 905 rather than be pulled through fluid openings 905 and into the Hind line. Additionally, because there may be more than one fluid opening ¹JOS, where an air bubble is caught above one, the air may not prevent fluid from {lowing through the other two openings.

Referring also to FiGS. 51 A-51C disposable housing assembly 804 may also include fluid pathway cover 910. Fluid pathway cover 910 may be received in cavity 912 formed on / within base portion 900, Fluid pathway cover 910 may, in some embodiments, include at least a portion of one or more channels (e.g., channel 914). The channels included in fluid pathway cover 910 may iluidly couple one or more volcano valve features (e.g. volcano valves 916} included on base portion 900. Volcano valves 9 !6 may include a protrusion having an opening extending through it. Additionally, fluid pathway cover 910 and base portion 900 may each define a portion of recess (e.g., recess portions 918, 920 included in base portion 900 and fluid pathway cover 910 respectively) for iluidly 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, compression fit, or the like). The fluid pathways defined by fluid pathway cover 9!ϋ and the volcano valves {.e.g., volcano valves 916) of base portion 900 may define a fluid pathway between reservoir 908 and cannula 922 for the delivery of the infusible fluid to the user via the infusion set. However, in some embodiments, fluid path cover 910 may include ai least a portion of ihe fluid path, and in some embodiments, fluid path cover 910 may not include at least a portion of the fluid path. In the exemplary embodiment, fluid pathway cover 910 may be laser welded to base portion 900. However, in other embodiments, fluid pathway cover 910 may also be connected to base portion 900 by conventional means {e.g., gluing, heat sealing, ultrasonic welding, compression fit, or me like) to achieve a generally fluid tight seal between fluid pathway cover 910 and base portion 900.

With reference also to FKlS. 54Λ-54C, disposable housing assembly 804 may further include valve membrane cover 924, Valve membrane cover 924 may be at least partially disposed over the volcano valves {e.g., volcano valve 916) and pumping recess 926 included on / within base portion 90(K Valve membrane cover 924 may include a flexible material, e.g., which may be selectively engaged against the volcano valves by reservoir valve 850, volume sensor valve 854, and measurement valve 856 of reusable housing assembly 802, e.g., for controlling the Slow of the infusible fluid. Additionally, valve membrane cover 924 may be resiliently deformed into pumping recess 926 by plunger pomp 852 to effectuate pumping of the infusible fluid. Valve membrane cover 924 may be engaged between base portion 900 and top portion 904 of disposable housing assembly 804 to form sea! 928 between valve membrane cover 924 and base portion 900. For example, in the exemplary embodiment, valve membrane cover 924 may be overmoMed onto base portion 900. In other embodiment, valve membrane cover 924 may be compressive^- pinched between base portion 900 and top portion 904 to form seal 928, Additionally / alternatively, valve membrane insert may be connected to one or more of base portion 900 and top portion 904, e.g., by gluing, heat sealing, or the like.

Referring also to FlGS. 53A-C, top portion 904 may include alignment tabs 930, 932 that may be configured to be at least partially received in openings 836, 838 of base plate 81 8 of reusable housing assembly S02 to ensure proper alignment between reusable housing assembly 802 and disposable housing assembly 804. Additionally, top portion 904 may include one or more radial tabs 934, 936, 938, 940 configured to be engaged by cooperating tabs 942, 944, 946, 948 of locking ring assembly 806, The one or more radial tabs (e.g., radial tab 940} may include stops {e.g., alignment tab stop 950, which may be used for welding, it's the tab that fits in the recess to locate and itltrasonieaily weld), e.g., which may prevent further rotation of locking ring assembly 806 once reusable housing assembly 802 and disposable housing assembly 804 are fully engaged.

As discussed above, valve membrane insert 924 may allow for pumping and flow of the infusible fluid by reservoir valve 850, plunger pump 852, volume sensor valve 854, and measurement valve 856. Accordingly, top portion 904 may include one or more openings (e.g., openings 952, 954, 956} that may expose at least a portion of valve membrane insert 924 for actuation by reservoir valve 85O₁ plunger pump 852, volume sensor valve 854, and measurement valve S56. Additionally, top portion 904 may include one or more openings 958, 960, 962 which may be configured to allow the fill volume to be controlled during filling of reservoir 90S, as will be discussed in greater detail below. Reservoir assembly 902 may include ribs 964, 966, 968 (e.g., as shown in FlO, 52A), which may be al least partially received in respective openings 958, 960, 962. As will be described in greater detail below, a force may be applied to one or more of ribs 964, 966, %8 to, at least temporarily, reduce the volume of reservoir 908. in some embodiment, U may be desirable to provide a seal between reusable housing assembly S02 and disposable housing assembly 804. Accordingly, disposable housing assembly SCM may include sealing assembly 970. Sealing assembly 970 may include, for example, an elastonieric member that may provide a compressible rubber or plastic layer between reusable housing assembly 802 and disposable bousing assembly 804 when engaged, thus preventing inadvertent disengagement and penetration by outside fluids. For example, sealing assembly 970 may be a watertight seal assembly and, thus, enable a user to wear infusion pump assembly SOO while swimming, bathing or exercising, ϊn a fashion similar to, e.g., disposable housing assembly 1 14, disposable housing assembly 802 may, in some embodiments, be configured to have reservoir 90S filled a plurality of times. 1 ϊowever, in some embodiments, disposable housing assembly 114 may be configured such thai reservoir 90S may not be refilled. Referring also to MGS. 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 tabs 1002, 1004, .1006, 1008 that may be configured to engage radial tabs 934, 936, 938, 940 of disposable housing assembly 804 in a manner generally similar to tabs 942, 944, 946, 94S of locking ring assembly 806 Accordingly, fill adapter 1000 may be reieasably 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 one another to reieasabiy engage locking tabs 1002, 1004, 1006, 1008 wjfh radial tabs 934. 936, 938, 940.

Fill adapter 1000 may further include ill ling aid 1010, which may include guide passage 1012, e.g., which may be configured to guide a needle of a syringe (not shown) to a septum of disposable housing assembly 804 to allow reservoir 90S of disposable housing assembly 804 to be filled by the syringe, tn some embodiments, guide passage 1012 maybe an angled bevel or other gradual angled bevel to further guide a syringe to a septum. FiH adapter 1000 may facilitate Jilting reservoir 908 by providing a relatively large insertion area, e.g., al the distal opening of guide passage 1012. Guide passage 1012 may generally- taper to a smaller proximal opening thai may be properly aligned with the septum of disposable housing assembly 804. when fill adapter 1000 is engaged with disposable housing assembly 804. Accordingly, till adapter 1000 may reduce the dexterity and aim necessary to properly insert a needle through the septum of disposable housing assembly 804 for the purpose of filling reservoir 908, As discussed above, disposable housing assembly 804 may configured to facilitate controlling the quantity of infusible fluid delivered to reservoir 908 during tilling. For example, membrane assembly 902 of disposable housing assembly 804 may include ribs 964, 966, 968 thai may be depressed and at least partially displaced into reservoir 908, thereby reducing the volume of reservoir 908. Accordingly, when infusible fluid is delivered to reservoir 908, the volume of fluid that may be accommodated by reservoir 908 may be correspondingly reduced. Ribs 964, 966, 968 may be accessible via openings 958, 960, 962 in top portion 904 of disposable housing assembly 804.

Fill adapter 1000 may include one or more button assemblies (e.g., button assemblies 1014, 1016, 3018} corresponding to ribs %4, 966, 968. That is, when fill adapter 1000 is releasably engaged with disposable housing assembly 804, buttons 1014, 1016« H)IS may be aligned with ribs 964, 966, 968. Button assemblies 1014, 1016, 1018 may be, for example, cantilever members capable of being 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 may correspo.ndi.ngly displace a respective one of ribs 964, 966, 698 into reservoir 908, causing an attendant reduction in the volume of reservoir 908.

For example, assume for illustrative purposes that reservoir 908 has a maximum capacity of 3.00 mL. Further, assume that button assembly 1014 is configured to displace rib 964 into disposable housing assembly 804, resulting in a 0.5 ml, reduction in the 3.00 ml. capacity of disposable housing assembly 804. Further, assume that button assembly 1016 is configured to displace rib 966 into disposable housing assembly 804, also resulting in a 0.5 røL reduction in the 3.00 mL capacity of disposable housing assembly 804. Further, assume that button assembly H) I K is configured to displace slot assembly 968 into disposable housing assembly 804, also resulting in a 0,5 ml. reduction in ihe 3.00 mL capacity of disposable housing assembly 804. Therefore, if the 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 the 3.00 røL capacity and then depresses button assemblies 1016 and 1014 (resulting in the displacement of rib 966 into disposable housing assembly 804), effectively reducing the 3.00 ml., capacity of reservoir 908 within disposable housing assembly 804 to 2.00 mL. 1« some embodiments, the user may first depress a respective number of button assemblies, effectively reducing the capacity of reservoir 908, and then fill reservoir 908. Although a particular number of button assemblies are shown, representing the exemplary embodiment, m other embodiments, the number of button assemblies may vary from a minimum of S to as many as is desired. Additionally, although for descriptive purposes, and in the exemplary embodiment, each button assembly may displace 0.5 mL, in other embodiments, the volume of displacement per button may vary. Additionally, the reservoir may be, in various embodiments, include a larger or smaller volume than described in the exemplary embodiment.

According to the above-described configuration, the button assemblies {e.g., button assemblies 1014. ! 016, S 08} may employed, at least in part, to control the fill volume of reservoir 908. By not depressing any of the button assemblies, the greatest 111! volume of reservoir 908 may be achieved. Depressing one button assembly (e.g.. button assembly 1014} may allow the second greatest fill volume to be achieved. Depressing two button assemblies (e.g., button assemblies 1014, 1016} may achieve the third greatest fill volume. Depressing all three button assemblies {e.g., button assemblies 1014, 1016, H)I S) may allow the smallest till volume to be achieve, Further, hi an embodiment button assemblies 1014, KH 6, 1018 may be utilized, at least in part, to facilitate filling of reservoir 908. For example, once a filling needle (e.g., which may be fluidly coupled to a vial of infusible fluid) has been inserted Into reservoir 908, button assemblies 1014, 1016, 1018 may be depressed to pump at least a portion of any- air thai may be contained within reservoir into the vial of infusible fluid. Button assemblies 1014, 1016, 1018 may subsequently be released to allow infusible fluid to flow from the vial into reservoir ⁽>ϋ&. Once reservoir 908 lias been filled with the infusible fluid, one or more button assemblies (e.g., one or more of button assemblies 1014, 1016, 1018} may be depressed, thereby squeezing at least a portion of the infusible fluid from reservoir 908 (e.g., via a needle used to fill reservoir 908 and back into the vial of infusible fluid). As discussed above, the volume of infusible OuId contained within reservoir 908 may be controlled, e.g., depending upon how many button assemblies are depressed {e.g., which may control how much infusible Unit! is squeezed back into the vial of infusible fluid).

With particular reference to FICJS. 62-64, filling aid 1010 may be pivotal Iy coupled to fill adapter base plate 1020. For example, Hl ling aid 1010 may include pivot members 1022, 1024 that may be configured to be received in pivot supports 1026, 1028, thereby allowing filling aid to pivot between an open position {e.g., as shown in FIGS. 57-61 } and a closed position (e.g., as shown in MGS. 63-64), The closed position may be suitable, e.g., for packaging fill adapter 1000, storage of fill adapter 1000, or the like. In order to ensure thai filling aid 1010 is property oriented for filling reservoir 90S, fill adapter 1000 may include support member 1030. To properly orient filling aid 1010. a user may pivot filling aid KHO Io a fully open position, wherein filling aid 10! 0 may contact support member 1030. According to an alternative embodiment, and referring also to RG. 65, till adapter

1050 may be configured to releasahly engage disposable housing assembly 804 via a plurality of locking tabs (e.g., locking tabs 1052, 1054). Additionally, ill! adapter 1050 may include a plurality of button assemblies (e.g., button assemblies 1056, 1058, 1060) that may interact with ribs 964, 966, 968 of disposable housing assembly 804 to adjust a fill volume of reservoir 908. Fill adapter 1050 may further include filling aid 1062, having guide passage 1064 configured to align a needle of a syringe with the septum of disposable housing 804, e.g,, for accessing reservoir 908 for the purpose of Oiling reservoir 90S with an infusible fluid. Filling aid S 062 may be connected to base piate 1066, e.g., as an integral component therewith, by gluing, heat sealing, compression fu, or the like. Referring also to FIGS. 66-74, vial fill adapter 1 100 may be configured to i^'aciϊitate filling reservoir 908 of disposable housing assembly 804 directly from a vial. Similar to fill adapter 1000, vial fill adapter 1 100 may include locking tabs 1 102, 1 104, 1 106, I H)S thai may be configured to engage radial tabs 934, 936, 938, 940 of disposable housing assembly in a manner generally similar to tabs 942, 944, 946, 948 αf locking ring assembly 806. Accordingly, vial fill adapter 1 100 may be releasahly engaged with disposable housing assembly 804 by aligning vial fill adapter 1 100 with disposable housing assembly 804 and rotating vial fill adapter S 100 and disposable bousing assembly 804 relative to one another to rcleasataly engage locking tabs 1 102, 1 104, ! 106, 1 108 with radial tabs 934, 936, 938. 940. As discussed above, disposable housing assembly 804 may be configured to facilitate controlling the quantity of infusible fluid delivered to reservoir 908 during filling. For example, membrane assembly 902 of disposable housing assembly 804 may include ribs 964, 966. 968 that may be depressed and at least partially displaced into reservoir 90S, thereby reducing tlie volume of reservoir 008. Accordingly, when infusible fluid is delivered to reservoir 908. the volume of fluid that may be accommodated by reservoir 908 may be correspondingly reduced. Ribs 964, %6, 968 may be accessible via openings 958, 960, 962 in top portion ¹⁾04 of disposable housing assembly 804. Vial fill adapter \ \ 00 may include one or more button assemblies (e.g., button assemblies 1 1 HX S 1 12, 1 1 14) corresponding to ribs 964, %6, 968 (e.g., shown in FKJ. 52A). That is, when vial fill adapter 1 100 is releasably engaged with disposable housing assembly 804, buttons 1 110, I 1 12, I 1 14 may be aligned with ribs 964, %6, 968. Button assemblies ! S 10, 1112, 1 1 14 may be, for example, cantilever members capable of being depressed. When vial fill adapter 1 100 is releasably engaged with disposable housing assembly 804, one or more of button assemblies H IO, i l 12, i f 14 may be depressed, and may correspondingly displace a respective one of ribs 964, 966, 698 into reservoir 908, thereby reducing the volume of reservoir 908. For example, assume for illustrative purposes that reservoir 908 has a maximum capacity of 3.00 ml... Further, assume that button assembly 11 10 is configured to displace rib %4 into disposable, housing assembly 804, resulting in a 0,5 nil, reduction in. the 3.00 ml., capacity of disposable housing assembly 804. Further, assume that button assembly 1 1 12 is configured to displace 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, Further, assume that button assembly 1 1 14 is configured to displace rib %8 into disposable housing assembly 804, also resulting in a 0.50 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Therefore, 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 1 1 12 and I i 14 (resulting in the displacement of ribs 966 and 968 into disposable housing assembly 804), effectively reducing the 3,00 ml. capacity of reservoir 90S within disposable housing assembly 804 to 2,0 mL.

Via! US! adapter 1 100 may further include vial filling aid assembly 1 1 16 that may be configured to fiuidiy couple a vial of infusible fluid to reservoir 908 of disposable housing assembly 804 via a septum. With particular reference Io FlG. 71, vial tilling aid assembly may include double ended needle assembly ! 1 18. Double ended needle assembly 1 1 18 may include first needle end 1 120 configured io penetrate the septum of a vial (not shown) and second needle end 1 122 configured to penetrate the septum of disposable housing assembly 804. As such, the via! and reservoir 908 may be lluidly coupled allowing infusible fluid to be transferred from the vial to reservoir 908. Double ended needle assembly 1118 may include vial engagement portion 1124 adjacent first end 1 120. Vial engagement arms 1 124. ! 126 may be configured to releasably engage, e.g., a vial cap, io assist in maintaining the fluid connection between double ended needle assembly 1 1 18 and the vial Additionally, double ended needle assembly H 18 may include body 1 128 thai, may be slidably received in opening I I 30 of vial filling aid body U 32, Via! filling aid body 1 132 may include stabilizer arms 1 134, 1 136, e.g., which may be configured to stabilize the vial during filling of disposable housing assembly SW. in one embodiment, the vial may be engaged with double ended needle assembly 1 1 18 e.g., such that first end 1 120 may penetrate the septum of the vial and the cap of the vial may be engaged by engagement arms 1 ! 24, 1126. Body 1 128 may be slidably inserted into opening ! i 30 such that second end 1 122 of double ended needle assembly 1 1 1 S may penetrate the septum of disposable body assembly 804.

Similar to fill adapter 1000, vial filling aid assembly 1 116 may be configured to be pivotally coupled to vial fill adapter base plate 1 138. For example, vial filling aid 1 1 16 may include pivot, members 1140, 1 142 that may be configured to be received in pivot supports 1 144. 1 146 (e.g., shown in FKJ. 71 }, thereby allowing vial filling aid \ 1 16 to pivot between an open position (e.g., as shown in FIGS. 66-70} and a closed position (e.g., as shown in. FIGS. 72-74). The closed position may be suitable, e.g., for packaging vial fill adapter 1100, storage of vial fill adapter 1 100, or the like, ϊn order to ensure that vial filling aid

1 1 16 is properly oriented for tilling reservoir 90S, vial fill adapter I SOO may include support member 1 148. To properly orient vial filling aid 1 1 16, a user may pivot, vial filling aid 1 1 36 to a fully open position, wherein vial 111 ling aid ! 1 16 may contact support member 1 148. Additionally, vial fill adapter base plate 1 13S may include one or more locking features (e.g., locking tabs 1 150, 1 S 52) that may engage vial tiling aid 1 1 16, and may maintain vial filling aid S 116 in the closed position. Via! fill adapter base plate 1 138 may also include features (e.g., tabs S 154, 1156) that may be configured to assist in retaining double ended needle assembly 1 1 18, e.g., by preventing slidable separation of double ended needle assembly 1 118 from vial filling aid body ! 132. As shown in FIGS. 72-74, filling aid assembly 1 116 is in a closed position. Sn this configuration, support member 1 148 may additionally function as a needle guard. When removing filling aid assembly U 16 from disposable housing assembly 804, support member 1 148 may function to safely allow a user to squeeze the ends and rotate filling aid assembly U 16 lor removal. As shown iu FlG. 70, in the open position, support member 1 148 may function as a stop to maintain proper orientation.

Referring again to FIGS. 57-73, the exemplar}- embodiments of the fill adapter include a grip feature (e.g., 1 166 in FtG. 72). Grip feature 1 166 may provide a grip interface for removal of the fill adapter from disposable bousing assembly 804. Although shown in one configuration in these figures, in other embodiments, the configuration may vary, In still other embodiments, a grip feature may not be included.

According to one embodiment, fill adapter base plate 1020 and vial fill adapter base plate i i 38 may be interchangeable components. Accordingly, a single base plate (e.g., either ill! adapter base plate 1020 or via! fill adapter base plate i 138 may be used with either filling aid 1010 or vial filling aid 1 1 16. Accordingly, die number of distinct components that are required for both filling adapters may be reduced, and a user may have the ability to select the tilling adapter that may be die most suitable for a given filling scenario, The various embodiments of the fill adapters may provide many safely benefits, including but not limited to: providing a system for filling the reservoir without handling a needle; protecting the reservoir from unintentional contact with the needle, i.e., destruction of the integrity of the reservoir through unintentional puncture; designed to be ambidextrous; in some embodiments, may provide a system for maintaining air in the reservoir.

According to other embodiments, the fill adapter may be configured to meter the fluid dispensed into the reservoir or the disposable housing assembly. Additionally / alternatively, the fill adapter may be configured to positively dispense (e.g., pump) the fluid into the reservoir of the disposable housing assembly. For example, and referring also to FIGS, 174- i 94, fill adapter 2700 may include a metering system for controlling the amount of fluid dispensed into the reservoir of the disposable housing assembly (e.g., reservoir 908 of disposable housing assembly 804 and a pumping mechanism for positively dispensing the Quid to reservoir 908. Generally, fill adapter 2700 may include a turn dial (e.g., turn dial 2702} that may adjust the volume of fluid to be dispensed into reservoir 908. For example, turn dial 2702 may actuate push plate 2704 { FIG. ISI). Push plate 2704 may- include one or more button features (e.g., button features 2706, 2708, 2710 shown in VlG. 187, 188). Button features 2706, 2708, 2710 may displace one or more of ribs 964, 966, 968 associated with reservoir 908, thereby reducing the available fill volume of reservoir 908. The degree to which ribs 964, 966, 968 are displaced may determine the available fill volume of reservoir 90S (as discussed previously}, mid therefore also the volume of fluid that may be dispensed into reservoir 908.

^"Turn dial 2702 and push plate 2704 may include cooperating features that may enable turn dial 2702 to adjust the displacement of ribs 964, 966, 968 by push plate 2704. In one embodiment, turn dial 3.702 and push plate 2704 may include cooperating ramp features, e.g. threads 2712 of push plate 2704 shown in FlG. I S?. Turn dial 2702 may include cooperating threads, such that when turn dial 2702 is turned in a first direction (e.g., clockwise) push plate 2704 may be ϋnearly moved in a first direction to displace ribs 964, 966, 968 into reservoir 908 to decrease the available fill volume of reservoir 908.

Conversely, when turn dial 2707 is turned in a second direction (e.g., counterclockwise) push plate 2704 may be linearly moved in a second direction allowing ribs 964, 966, 968 to move to increase the available fill volume of reservoir 908. In addition to cooperating ramp features, various additional / alternative features may be utilized, including, but not limited to. cam features, rack and pinion features, etc. Further, till adapter 2700 may include otie or more return features (such as springs, or other bias members; not shown) thai may ensure that push plate 2704 is biased io increase the available IWl volume of reservoir 908 iα response to turn dial 2702 being adjusted from a smaller available fill volume to a larger available fill volume (e.g., as turn dial 2702 is turned in a counterclockwise direction in foregoing example).

Additionally, while not shown, turn dial 2702 may be calibrated and turn dial 2702 and/or housing 2714 may include indicia that may indicate the available fill volume of reservoir 908 at a given rotational position of turn dial 2702. For example, turn dial 2702 may include a pointer and housing 2714 may include numerical indicia indicating available Sill volume of reservoir 908. As such, the available Sill volume of reservoir 908 may be the numerical value indicated by the cooperation of the pointer of turn dial 2702 and the numerical indicia of housing 2714.

As mentioned above, fill adapter 2700 may be configured to positively dispense fluid into reservoir 908. In one embodiment, fill adapter 2700 may include a pump mechanism configured to pump air into a vial (e.g., via! 2716 shown in FIG. 18 ϊ }. For example, pumping air into via! 2716 may pressurize viai 27 f 6 to a pressure greater than a pressure within reservoir 908, As such, when vial 2716 is lluidly coupled with reservoir 908, the greater pressure within vial 2716 may force fluid contained within vial 2716 into reservoir 90S. Consistent with the foregoing description, the volume of fluid transferred from vial 2716 into reservoir 90S may be controlled by turn dial 2702 and push plate 2704 (e.g., based upon, at least in part, the interaction between button features 2706, 2708, 2710 and fingers 964, 966, 96S). The fill adapter may include a pump mechanism. According to one embodiment, til! adapter 27Ot⁾ may include pump bulb 2718, which may include a flexible convex member that may be biased toward a first volume, and compressible to a second volume that is less than the first volume. For example, pump bulb 27! S may be compressed from the first volume to the second volume when pump bulb 271 8 is pressed by a user^'s thumb or linger. While not shown, a pumping volume (e.g., the difference between the first volume and the second volume of pump bulb 27 IS.! may be controlled at least in part, by turn dial 2702, For example, the pumping volume may be controlled by turn dial 2702 to correspond to the available fill volume of reservoir 908 (e.g., the pumping volume may be a pumping volume of air that may result a transfer of a volume of fluid generally equal to the available till volume of reservoir 908).

Further, while not shown, pump bulb 2718 may include an inlet having an associated one-way valve that may allow air to enter pump bulb 2718 via the inlet when pump bulb 2718 expands from the second volume to the lirsi volume, and may prevent air from exiting inlet when pump bulb 2718 is compressed from the first volume to the second volume. Additionally, while also not shown, pump bulb 2718 may include an outlet having an associated one-way valve that may allow air to exit pump bulb 2718 via the outlet when pump bulb 27! S is compressed from the first volume to the second volume, and may prevent air from entering pump bulb 2718 via the outlet when pump bulb 27 i 8 expands from the second volume to the first volume. Various valve mechanisms may be employed for the one-way inlet valve and the one-way outlet valve, including, but not limited to, ball valves, flap valves, diaphragm valves, and the like.

In various additional / alternative embodiments the pump mechanism may include, but is not limited to, a piston pump, a diaphragm pump, or the like. Further, while pump bulb 2718 has been described as being compressed by a user's thumb or finger, various additional / alternative embodiments of a pump mechanism may be actuated by a turn crank, a lever, a pair of squeeze handles, a foot pump, and/or various other means of actuation.

The outlet of pump bulb 2718 may be fiuidly coupled to pressure needle 2720 ( FKJ. IS I ). Pressure needle 2720 may be configured to penetrate a septum of vial 2716. As such, when pressure needle 2720 has penetrated the septum of vial 2716 and pump bulb 2718 is pumped (e.g., by compressing pump bulb 271 S from the first volume to the second volume) air may be transferred from pump bulb 27 i 8 into vial 2716. The transfer of air from pump bulb 2718 into vial 2716 may increase the internal pressure within vial 27! 6, The one way valve associated with the outlet of pυmp bulb 27 IS may prevent ihe retrograde flow oi^'flυid from vial 2716 into pump bulb 2718 via pressure needle 2720. Additionally, as schematically shewn in FKl 194, hydrophobic filter 2722 may be associated with pressure needle 2720. Hydrophobic Jiiter 2722 may include any variety of gas-permeable hydrophobic materials, such as a POIlE- X™ material a GORE™ material or the like (POREX is a trademark of Porex Corporation in the United States and/or other countries, GORE is a trade mark of VV. L. Gore Si Associates, Inc. in the Unites States and/or other countries). Hydrophobic filter 2722 may allow the transmission of gaseous fluids (such as air), but may resist / prevent the passage of liquids (such as insulin or various other infusion fluids). Additionally, hydrophobic filter 2722 may have a restricted flow rate of gaseous fluids, and may, therefore, control the rate at which air can be pumped out of pump bulb 2718 and into vial 2716.

Fill adapter 2700 may further include a transfer needle (e.g., transfer needle 2724 shown in FIG, ISI ). Transfer needle 2724 may allow fluid to be transferred from vial 2716 to reservoir 90S of disposable housing assembly 804. Referring also to FIG, 183, in a "fill configuration" of fill adapter 2700. transfer needle 2724 may extend into recess 2726 of fill adapter 2700. Recess 2726 of fill adapter 2700 may be configured to at least partially receive disposable housing assembly 804. Further, fill adapter 2700 may be configured to align (e.g., via openings 2728, 2730 configured to cooperate with alignment tabs 930, 932 of disposable housing assembly 804} disposable housing assembly 804 relative to fill adapter 2700, such that transfer needle 2724 may be aligned to penetrate a septum of disposable housing assembly 804 to transfer fluid from vial 2716 into reservoir 908 of disposable housing assembly 804.

As shown irs the schematic view of FlG. 194, pressure needle 2720 may be configured to extend farther imo vial 2716 than transfer needle 2724. The foregoing configuration may reduce the likelihood that air introduced into vial 27 ϊ 6 by pump bulb 2718 may be transferred via transfer needle 2724. That is, in operation pressure needle 2720 may be at a higher relative position within via! 2716 as compared to transfer needle 2724. As such, air bubble rising within via! 2716 (which may contain a liquid to be transferred to reservoir 90S) may not pass by, and be drawn into, transfer needle 2724, as transfer needle 2724 may be at a lower relative position within via! 2617 as compared to pressure needle. Pressure needle 2720 and transfer needle 2724 may be retained by vial adapter 2732 (FIO. J 93). Additionally, vial adapter 2732 may include vial receptacle 2734 that may be configured to at least partially receive vial 2716 and align pressure needle 2720 and transfer needle 2724 with the septum of vial 2716, As such, insertion of vial 2716 into vial receptacle 2734 may align pressure needle 2720 and transfer needle 2724 with the septum of vial 2716 without lhe need for further alignment by the user. Further, vial adapter 2732 may retain pressure needle 2720 and transfer needle 2724 in a desired relative alignment, such that pressure needle 2720 may extend farther into vial 2716 than transfer .needle 27.24, as described above. Also referring to FIGS. 199A- 199M, vial adapter 2732 may be configured to be received in receptacle 2736 of main plate 2738 of fill adapter 2700 (also see FIG. 181 ). Vial adapter 2732 may include needle carriage 2732a as well as one or more tabs (e.g., tabs 2732b, 2732c). In some embodiments, via! 2716 may be removed from vial adapter 2732 by pulling up on vial 2716. Pulling up on vial 2716 may also cause needle carriage 2732a to move upwards until being engaged by the tabs 2732b, 2732c. Fingers 2733a, 2733b may be depressed by the user, in some embodiments, depressing fingers 2733a. 2733b may push via! 2716 further upward, and may disconnect vial 2716 from needles 2720.. 2724. As such, the safety of removing vial 2716 from vial adapter 2732 may be improved. In some embodiments, vial adapter 2732 may additionally Include seal 2735a and hydrophobic filter 2735b. However, in other embodiments, the vial adapter 2732 may include a check valve. Referring also to FIG. 184, in an embodiment pressure needle 2720 may terminate within vial adapter 2732, and may be flυkily coupled to opening 2740 of via! adapter 2732. When via! adapter 2732 is assembled with main plate 2738, opening 2740 may be fluidiy coupled with the outlet of pump bulb 27 ! 8 such that air pumped out of pump bulb 271 S may be received through opening 2740 and transferred to vial 2716 via pressure needle 2720.

In operation, to fill a disposable housing assembly 804, a user couples the via! adapter 2732 to the main plate 2738. The vial 2716 is then coupled to the vial adapter 2732. In performing these steps (see also FIGS. 199A-I99H) the transfer needle 2724 penetrates the septum of the disposable housing assembly 804 (see 199D) and also, the septum of the via! 2716 (see FiG. 199K). Thus, in various embodiments, the transfer needle 2724 does not penetrate the septum of the vial 2716 until the transfer needle. 2724 also penetrates the septum of the disposable housing assembly 804. This ensures that if the vial 2716 is pressurized, the contents of the vial 2716 will not begin to flow until the transfer needle 2724 has penetrated the septum of the disposable housing assembly 804, thereby limiting the amount of wasted vial contents.

Thus, to fill a disposable housing assembly 804, the user may couple disposable housing assembly 804 in recess 2726 of main plate 2738 (e.g., including aligning disposable housing assembly 804 relative to 111! adapter 2700 via openings 2728, 2730 configured to at least partially receive alignment tabs 930, 932 of disposable housing assembly S(H), Disposable housing assembly 804 may be retained relative to !1Il adapter 2700 using bottom door 2742, which may pivolally close to at least partially cover recess 2726 to retain disposable housing assembly 804 at least partially within recess 2726. A user may then couple the vial adapter 2732 to the main plate 2738 and then, couple a vial 2716 to the vial adapter 2732. Coupling via! adapter 2732 to main plate 2738 may result in transfer needle 2724 penetrating the septum of disposable housing assembly 804. Additionally, coupling vial adapter 2732 to main plate 2738 may couple opening 2740 with the outlet of pump bulb 27S S. The user may then adjust turn dial 2702 (e.g., which may thereby cause movement of push plate 2704} io the desired available fill volume of reservoir 908. The user may then actuate pump bulb 2718 (e.g., by compressing and releasing pump bulb 2718). The user may continue to actuate pump bulb 27 S S until no more bubbles are observed rising within via! 2716 (e.g., rising from pressure needk 2720). Additionally / alternatively, pump bulb 27 S 8 may be configured such that a single complete actuation of pump bulb 2718 may be sufficient to effect a complete transfer (e.g., the volume of air transferred from pump bulb 2718 to vial 2716 during a single actuation of pump bulb 2718 may be sufficient to produce the transfer of the maximum fill volume of reservoir 908). According to one embodiment, fill adapter 2700 may be configured to overfill reservoir 908 (e.g., to transfer a volume of fluid from vial 2716 that is at least partially greater than the available fill volume of reservoir 90S, as determined by the settings of turn dial 2702). Overfilling reservoir 908 may allow the fluid passages associated with disposable housing assembly 804 to be primed with fluid, thereby obviating the need to later prime the fluid lines of disposable housing assembly 804. Still referring to FIGS. S99A-I99H, in some embodiments, the fill adapter 2700 includes vial fingers 2744a. 2744b. As shown in FiGS. 199A- 199M, as the vial 2716 is introduced to the vial adapter 2732, the via! 27 ϊ 6 overcomes the spring force of the vial fingers 2744a, 2744b. However, as the via! 27 S 6 reaches a end on the needle carriage 2732a, the vial fingers 2744a, 2744b return force and act to maintain the position of the via! 2716,

Referring now to FIGS, 200-2028, another embodiment of the fill adapter is 2750 is shown. In various embodiments of this embodiment of the fill adapter, the vial adapter 2762 includes a needle carriage 2754 which includes vial needles 2756a, 2756b and transfer needle 2756c. in some embodiments, the needles 2756a, 2756b, 2756c are 24 gauge stainless steel. However, in other embodiments, the gauge of the needles may vary. In various embodiments, the gauge of needle is a balance between flexibility and efficiency. The needle carriage 2754 is slidably engaged to the interior of the vial adapter housing 2752. The vial adapter 2762 includes a check valve 27SS and a filter 2766. Sn some embodiments, the filter 2766 may be a .2 micron filter, or any other filter that prevents dust and other unwanted particulate matter, from entering the air line and the via! (not shown). In the exemplary embodiment, the filter 2766 is a hydrophobic filter which may include any variety of gas-permeable hydrophobic materials, such as a POREX™ material, a GORE™ material, or the like (POREX is a trademark of Porex Corporation in the United States atxt'or other countries, GORE is a trade mark of W. L. Gore & Associates, Inc. in the Unites States and/or other countries). Sn some embodiments, the cheek valve 2758 is a duck bill valve. The duck bill valve serves as a check valve and a seal. However, in other embodiments, the check valve may be any type of check valve. In other embodiments, the check valve is not included and only a hydrophobic filter is used. In some embodiments, the hydrophobic filter my be as described above, and in these embodiments, a separate seal may also be used.

The vial adapter 2762 further includes a vial adapter housing 2752. The housing contains the needle carriage 2754 and is adapted to removably attach to the fill adapter base 2768 by way of the receptacle 2770. The fill adapter base 2768 includes a main plate 2760 which includes the receptacle 2770. The receptacle 2770 includes at least one key, and in the exemplar}' embodiment, the receptacle 2770 includes two keys 2764b. The keys 2764b in the exemplary embodiment, are differently sized, however, in other embodiments, they may be the same size. The different sizes of the keys 2764b allows for the vial adapter 2762 to be located in the intended orientation. The keys 2764b fit into locking features 2764a located inside the vial adapter housing 2752. Once the keys 2764b and locking features 2764a are fit together, a clockwise turn of the vial adapter 2762 locks the vial adapter 2762 to the receptacle 2770. However, in various other embodiments, the locking features 2764a located inside the vial adapter housing 2752 may be designed such thai a counterclockwise turn of the vial adapter 2762 locks the vial adapter 2 /62 to the receptacle 2770.

Locking the via! adapter 2762 io the receptacle 2770 may be desirable for many reasons, including, but not limited to, maintaining the correct orientation during fill and preventing the needles irom bending or twisting during fill The locking system described above also ensures correct orientation of the vial adapter with respect to the till adapter base 2768,

Referring now to FIGS. 203A-203J, in operation, to fill a disposable housing assembly 804, a user couples the vial adapter 2762 to the receptacle 2770. The vial adapter 2762 is then rotated clockwise, locking the vial adapter 2762 to the receptacle 2770 {see FIG. 203C). The vial 2716 is then coupled to the vial adapter 2762. In performing these steps the transfer needle 2756c penetrates the septum of ihe disposable housing assembly 804 (see 203E) and also, the septum of the vial 2716 (see FKJ. 203 F). Thus, in various embodiments, the transfer needle 2756c does not penetrate the septum of the vial 2716 until the transfer needle 2756c also penetrates the septum of the disposable housing assembly 804. This ensures that if the vial 2716 is pressurized, the contents of the via! 2716 will not begin to flow until ihe transfer needle 2756e lias penetrated the septum of the disposable housing assembly 804, thereby limiting the amount of wasted vial contents.

Thus, to fill a disposable bousing assembly 804, in this embodiment, the user couples the disposable housing assembly 804 to the fill adapter base 2768 in a similar fashion as described above with respect to ihe fill adapter 2700. A user may then couples the vial adapter 2762 io the receptacle 2770, turns the vial adapter 2762, locking the vial adapter 2762 to ihe receptacle, and then, couples a vial 27 ! 6 io the vial adapter 2762. The user may then adjust the turn dial and follow similar a similar process as described above with respect to the fill adapter 2700 for filling the disposable housing assembly 804.

Referring to FIGS. 2030-203 F, introducing the vial 2716 So the vial adapter 2762, via! fingers 2772a, 2772b, including a bent portion that grasps and holds the narrow portion of the vial 2716. However, as shown in FICr. 203F₁ in some embodiments, a distance remains between the top of the vial 27 !(S {i.e., the area including the septum) and the bent portion of the vial lingers 2772a, 2772b. As shown in FIG. 203G, to remove the vial, a user applies force to the vial 2716 in an upward direction. The upward force first pulls the vial 2716 upwards such that the .needles 2756a, 2756b are no longer in contact wiih the contents of the vial 2716, rather, the needles 2756a. 2756b are inside the septum of ihe via! 2716. This ensures that if the vial 2716 is pressurized, the contents of the vial 2716 will not continue to flow while the vial 27 S 6 is being removed from the vial adapter 2756 thereby limiting the amount of wasted vial contents.

Referring to FIG. 203E, the vial adapter 2762 additional !y includes a disc 2774 (set¹ also FIG, 200). The disc 2774 remains at the bottom of the via! adapter 2762 (which may also be referred lo as the receptacle end of the via! adapter 2762) until the needle carriage 2754 reaches the bottom of the via! adapter 2762. Referring to FIG. 203E, the needle carriage 2754 having reached the bottom of the via! adapter 2762, the needle carriage 2754 is now connected to the disc 2774. The disc 2774 includes features which mate with the needle carriage 2754 such that, when the needle carriage 2754 moves upward, or towards the top or vial end of the vial adapter 2762, as seen in FIG. 2031 S, the disc 2774 accompanies the needle carriage 2754.

Referring now to FSGS. 204A-204C, a sequence showing the progression of the needle carriage 2754 and the relationship of the needle carriage 2754 with the disc 2774 is shown without a vial. As seen in FtG. 204C. once the needle carriage 2754. together with the disc 2774, reach the top section of ihe vial adapter 2762, the disc 2774 is locked in place by the wail features of the via! adapter 2762.

Referring no* to FIGS. 203I-203K, after the vial 2716 is lilted outside of the vial adapter 2762, the vial adapter 2762 may be rotated counter clockwise (FIG. 203J), unlocking the vial adapter 2762 from the receptacle 2770, and the vial adapter 2762 may then be lifted off the fill adapter base 2768 (FIG. 203K). Additionally, as is shown in RG. 203 K, the needles 2756a, 2756b. 2756c are contained within the via! adapter 2762 thus protecting the user and others from interaction with the needles 2756a, 2756b, 2756c .

Referring also to FIGS. 195A-198, another embodiment of a fill adapter (e.g., fill adapter 2800} is shown. Fill adapter 2800 may be generally similar to fill adapter 2700, including a turn dial (e.g., turn dial 2802} that may actuate a push plate (e.g., push plate 2804) for setting an available IsSi volume of reservoir 90S of disposable housing assembly 804 { FKJS. i 97-198). FiH adapter 2800 may also include via! adapter 2806 configured to reieasabiy couple a vial to fill adapter 2800 for transferring iluid from the vial to reservoir 908 of disposable housing assembly 804. Fill adapter 2806 may include a pressure needle and/or a transfer needle respectively configured to introduce air into the via! and allow fluid to be transferred from the vial to reservoir 908 of disposable housing assembly 804. While fill adapter 2800 is shown including recess 2808 and pivoting door 2810 for retaining disposable homing assembly to fill adapter 2800, in other embodiments, the till adapter may utilize locking features, e.g., which may refeasably engage tabs 934, 936, 938_., 940 disposable housing assembly 804,

With respect to the embodiments including a vial adapter removably connectable to a 111! adapter base, in some embodiments, the via! adapter may be a one-use, i.e., disposable portion, and the fill adapter base may be a multi-use, i.e., reusable, portion. Sn some embodiments, upon removal of the vial from the vial adapter, the needle carriage becomes locked in the end position. This may be desirable to prevent reuse and reuse may contaminate vials and disposable housing assemblies, for the transfer needle may become contaminated while stored between uses.

Fill adapter 2SO0 may include actuation button 2812, which may be disposed in turn dial 2802. Actuation button 2.812 may be configured as a plunger pump, e.g., which may pump air into the vial to effectuate fluid transfer from toe via! into reservoir 908, in a manner as described above. Various additional / alternative pumping mechanisms may similarly be used, as described above. Additionally, actuation button 28! 2 may operate a bias member (e.g., spring 28 ! 4} that may limit the amount of force that is transferred to reservoir 908- For example, spring 2814 may be disposed between actuation button 2812 and the pumping member that may actually pump air into the vial As such, the force thai may be transferred to reservoir 908 may be limited to the spring force of spring 2814. As discussed above, reusable housing assembly S02 may include battery 832, e.g., which may include a rechargeable battery. Referring also to FIGS, 75-80, battery charger 1200 may be configured to recharge battery 832. Battery charger !2OO may include housing 1202 having top plate 1204. Top piate 1204 may include one or more electrical contacts 1206, generally, configured to be electrically coupled to electrical contacts 834 of reusable housing assembly 802, Electrical contacts 1206 may include, but are not limited to, electrical contact pads, spring biased electrical contact members, or the like. Additionally, top plate 1204 may include alignment tabs 1208, 1210, which may be configured to mate with openings 836, 838 in base plate 818 of reusable housing assembly 802 (e.g., as shown in FlG, 35C). The cooperation of alignment tabs 1208, 1210 and openings 836, 838 may ensure that reusable housing assembly 802 is aligned with batter}' charger 1200 such that electrical contacts 1206 of batten' charger 1200 may electrically couple with electrical contacts 834 of reusable housing assembly 802. With reference also to FIGS. 77 and 78, battery charger 1200 may be configured Io releasably engage reusable housing assembly 802. For example, in a similar manner as disposable housing assembly 804, battery charger 1200 may include one or more locking tabs (e.g., locking tabs i212, 1214 shown in FiG. 76}. The locking tabs (e.g., locking tabs 1212, 1214) may be engaged by labs 942, <M4, 946, 948 of locking ring assembly 806, As such, reusable housing assembly 802 røay be aligned with battery charger ! 200 (via alignment tabs 12QB, 1210} with locking ring 806 in a first, unlocked position, as shown in FSO. ??. Locking ring 806 may be rotated relative to battery charger 1200 in the direction of arrow 1216 to reieasably engage tabs *>42, 944, 946, 948 of locking ring 806 with the locking tabs (e.g., locking tabs 1212, 1214} of battery charger ] 200, as shown in FiG. 78. in an embodiment, battery charger 1200 may include recessed region 1218, e.g., which may, in ihe exemplary embodiments, provide clearance to accommodate reusable housing assembly 802 pumping and vaiving components. Referring also to FSGS. 19 & 80, battery charger 1200 may provide electrical 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 indicative of a fully engaged reusable housing is not provided, current may not he provided to electrical contacts 1206. According to such an embodiment, the risk associated with an electrical short circuit (e.g., resulting from foreign objects contacting electrical contacts 1206) and damage to reusable housing assembly 802 (e.g., resulting from improper initial alignment between electrical contacts 1206 and electrical contacts 834) may be reduced. Additionally, battery charger 1200 may not unnecessarily draw current when battery charger is not charging reusable housing assembly 802.

Still referring to FIGS. 79 and 80, battery charger 1200 may include a lower housing portion 1224 and top plate 1204. Printed circuit board 1222 {e.g., which may include electrical contacts 1206) may be disposed within a cavity included between top plate 1204 and lower housing portion 1224.

Referring also to FKJS. 81-89, various embodiments of battery charger/ docking stations are shown FIGS. 8 ! and 82 depicts desktop charger 1250 including recess 1252 configured to mate with and recharge a reusable housing assembly (e.g., reusable housing assembly 802). The reusable housing assembly may rest in recess 1252 and or may be reieasably engaged in recess 1252, in a similar manner as discussed above. Additionally, desktop charger 1250 may include recess 1254 configured to mate with a remote control assembly (e.g., remote control assembly 300). Recess 1254 may include a USB plug 1256, e.g., which may be configured to couple with the remote control assembly when the remote control assembly is disposed within recess 1254. USB plug 1256 may allow for data transfer to/from the remote control assembly, as well as charging of remote control assembly. Desktop charger 1250 may also include USB port 1258 (e.g.. which may include a mini-USB port), allowing desktop charger to receive power (e.g., for charging the reusable housing assembly and/or the remote control assembly). Additionally / alternatively USB port 1258 may be configured for data transfer to / from remote control assembly and/or reusable housing assembly, e.g., by connection to a computer (not shown), Referring to FIGS. 83A-83B, similar to the previous embodiment, desktop charger

1260 may include recess 1262 for mating with a reusable housing assembly (e.g., reusable housing assembly 1264). Desktop charger may also include recess 1266 configured to receive a remote control assembly (e.g., remote control assembly 1268). One or more of recess 1262, 1266 may include electrical and/or data connections configure to charge and/or transfer data to/from reusable housing assembly 1262 and/or remote control assembly 1268, respectively.

Referring to FIGS. 84A-84B, another embodiment of a desktop charger is shown. Similar to desktop charger 1260, desktop charger 1270 may include recesses (not shown) for respectively mating with reusable housing assembly 1272 and remote control assembly 1274, 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 connection configured to charge and/or transfer data to/from reusable housing assembly 1272 and/or remote control assembly 1274, as described in various embodiments above. Referring to FIG. 85A-85D, collapsible charger 1280 may include recess 1282 for receiving reusable housing assembly 1284 and remote control assembly 1286, Collapsible charger 1280 may include various electrical and data connection configured to charge and/or transfer data to/from reusable housing assembly 1284 ami/or remote control assembly 1286, as described in various embodiments above. Additionally, as shown in FIGS. 85B-85 D, col lapsible charger 1280 may include pi votable cover 1288. Fi voiabie cover 1288 may be configured to pivot between an open position (e.g., as shown in RG. 85B), in which reusable housing assembly 1284 and remote control assembly 1286 may be docked in collapsible charger 1280, and a dosed position {e.g., as shown in FIG. 85D), in which recess 1282 may be covered by pivotabSe cover 1288. hi ihe closed position, recess 1282, as well as any electrical and/or data connections disposed therein, may be protected from damage.

Referring to FIG. 86« wall charger 1290 may include recess 1292 configured to receive reusable housing assembly 1294. Additionally, wall charger 1290 may include 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, e.g., thereby providing a relatively slim profile. A rear portion of wall charger 1290 may include an electrical plug, configured to allow wall charger to be plugged into an electrical recepiack. As such, wall charger ) 290, while plugged into the electrical receptacle, may achieve a wall mounted configuration. Additionally, while plugged into the electrical receptacle, wall charger 1290 may be provided with power for charging reusable housing assembly S 294 and/or remote control assembly 1298.

Referring to FIG. 87, wall charger S 300 may include recess 1302 configured to receive remote control assembly 1304. Additionally, wall charger may include a recess (nυt shown) configured to receive reusable housing assembly 1306. Wall charger 1300 may be configured to position remote control assembly 1304 and reusable housing assembly 1306 in a baek-to-hack configuration, which may provide a relatively thin profile. Additionally, wall charger 1300 may include an electrical plug 1308 configured to be plugged into an electrical receptacle. Electrical plug 1308 may include a stowahie configuration, in which electrical plug 1308 may be pivotable between a deployed position (e.g., as shown), and a stowed position, in the deployed position, electrical plug 1308 may be oriented to be plugged into an electrical receptacle. In the stowed position electrical plug 1308 may be disposed within recess 1310, which may protect electrical plug 1308 from damage and/or from damaging other Hems.

Referring to FlG, 88, charger 1320 may include recess 1322 configured to receive reusable housing assembly 1324, Charger 1320 may additionally include a recess (not shown) configured to receive remote control assembly 1326. Charger 1320 may additionally include cover 1328. Cover 1328 may be configured to pivot between an open position {as shown) and a closed position. When cover 1328 is in the open position, reusable housing assembly 1324 and remote control assembly 1326 may be accessible (e.g., allowing a user to remove / install reusable bousing assembly 1324 and/or remote control assembly 1326 from / into charger 1320. When cover ! 324 is in the closed position, cover 1328 and charger body 1330 may substantially enclose reusable bousing assembly 1324 and/or remote control assembly 1 326 and/or recess 1322 and the recess configured Io receive remote control assembly 1326, thereby providing damage and/or tamper protection for reusable housing assembly 1324, remote control assembly 1326 and/or any electrical and/or data connection associated with charger ! 320,

Referring to FIGS. 89A-89B, wall charger S 350 may include recess 1352 configured to receive remote control assembly 1354, Wall charger 1350 may also include recess 1356 configured to receive reusable housing assembly 1358. Wall charger 1350 may be configured to position remote control assembly 1354 and reusable housing assembly 1358 in a generally side-by-side configuration, thereby providing a relatively slim profile.

Charger 1350 may additionally include electrical plug 1360, e.g., which may be configured to be plugged into an electrical receptacle. Electrical plug 1360 may include a stowable configuration, in which electrical plug 1360 may be pivoiabie between a deployed position (e.g., as shown), and a slowed position, In the deployed position, electrical plug 1360 may be oriented to be plugged into an electrical receptacle, ϊrt 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.

Referring also to FIGS. 134 through 145, another embodiment ofa battery charger (e.g., charger 2600), which may be used to recharge battery 832 of reusable housing assembly 802, is shown. Similar to previously discussed embodiments, charger 2600 may be configured to charge both a reusable housing assembly (e.g., reusable housing assembly 802), as well as a companion remote control assembly (e.g., remote control assembly 2602). For example, charger 2600.may include reusable housing assembly charging portion 2604 configured to cooperate with reusable housing assembly 802, for the charging thereof As shown, reusable housing assembly charging portion

2604 may include a .recess in top cover 2606 of charger 2600 that may at least partially receive reusable housing assembly 802. Jn a similar manner as discussed above, reusable housing assembly charging portion 2604 may include one or more alignment tabs (e.g., alignment tabs 2608, 2610} that may be configured to mate with openings 836, 838 in base plate 818 of reusable housing assembly 802 (shown in FIG. 35C). The alignment of tabs 2608, 2610 and openings 836, 838 may ensure that reusable housing assembly 802 is aligned with reusable housing assembly charging portion 2604 such that electrical contacts of charger 2600 (e.g., contacts 2612} may electrically couple with electrical contacts S34 of reusable housing assembly 802,

Also, in a similar manner as discussed above, reusable housing assembly charging portion 2604 may be configured to reSeasably engage reusable housing assembly 802. For example, in a similar manner as disposable housing assembly 804, reusable housing assembly charging portion 2604 may include one or more locking labs (e.g., locking tabs 2614, 2616, 2618 visible in RG. 134). The locking tabs (e.g., locking tabs 2614, 2616, 2618) may be engaged by tabs 942, 944. 946. 948 of locking ring assembly 806. As such, reusable housing assembly 802 may be aligned with charger 2600 (via alignment tabs 260S, 2610) with locking ring 806 in a first, unlocked position, and Socking ring 806 may be rotated relative to charger 2600 in a first direction (e.g., clockwise in an exemplary embodiment) to releasably engage tabs 942, 944, 946, 948 of locking ring 806 with the locking tabs (e.g., locking tabs 2614. 2616. 2618) of charger 2600, Sn some embodiments, reusable housing assembly charging portion 2604 may include recess 2620 configured to receive locking ring nub 808, e.g.. which may further ensure proper alignment of reusable housing assembly 802 with charger 2600, Additionally, as shown, top cover 2606 may Include a recess (e.g.. recess 2622} adjacent to reusable housing assembly charging portion 2604 that may facilitate removal of reusable housing assembly 802 from charger 2600 (e.g., by allowing a user to at least partially grip reusable housing assembly S02 with a thumb or Singer). Additionally, recess 2622 may facilitates opening of lid 2626.

In addition to reusable housing assembly charging portion 2604, charger 2600 may include remote control assembly charging portion 2624, e.g., that may allow companion remote control assembly 2602 to be charged along with reusable housing assembly 802. hi the exemplary embodiment, remote control assembly charging portion 2624 is configured to receive a remote control, ϊn some embodiments, the remote control may include a glucose strip reader on portion of the remote control intended to be placed into remote control assembly charging portion 2624. In these embodiments, remote control assembly charging portion 2624 may accepts the remote control during charging such that the strip reader may be blocked by remote control assembly charging portion 2624. This may be desirable to prevent a user from using the glucose strip reader while the remote control is on the charger. Remote control assembly charging portion 2624 may include a recess configured to receive al least a portion of remote control assembly 2602, Charger 2600 may include lid 2626, e.g., which may be adjacent to, and/or at least partially define, remote control assembly charging portion. For example, }\ά 2626 may, in an open position, extend generally upwardly relative to top cover 2606. Further, lid 2626 may include surface 2628 that may be at least generally aligned with remote control assembly charging portion 2624. As such, lid 2626 may facilitate insertion of remote control assembly 2602 into remote control assembly charging portion 2624 (e.g., by allowing remote control assembly to generally slide downwardly along surface 2628 and into remote control assembly charging portion 2624). Additionally, lid 2626 may support remote control assembly 2602 while coupled in remote control assembly charging portion 2624 (e.g., to reduce stress imparted on remote control assembly 2602 from being bumped, etc., from being transferred to electrical connection or the like associated with remote control assembly charging portion 2624}.

With particular reference also to FIGS. 136- ! 37, charger 2600 may include lock cover 2630, e.g., which may at least partially conceal and/or protect reusable housing assembly charging portion 2604 when not in use (e.g., when a reusable housing assembly is not being charged or stored on charger 2600). In a similar manner to reusable housing assembly 802, lock cover 2630 may include one or more locking tabs that may interact with the locking tabs of charger 2600 (e.g.. locking tabs 2614, 2616, 26! S) to allow reieasable engagement of lock cover 2630 with reusable housing assembly charging portion 2604. As shown in F-⁽G. 137, Sock cover 2630 may provide protection for / concealment of reusable housing assembly charging portion 2604. e.g.,, without impeding access to and/or the use of remote control assembly charging portion 2624. As such, reusable housing assembly charging portion 2604 may be protected / concealed while still allowing remote control assembly 2602 to be charged by / reside in charger 2600. Further, while not shown, when neither reusable housing assembly charging portion 2604 nor remote control assembly charging portion 2624 are in use, lid 2626 may be pivoted to a closed position, e.g., disposed over both reusable housing assembly charging portion 2604 and remote control assembly charging portion 2624. As such, in the closed position lid 2626 may provide protection for charger 2600 when charger 2600 is not in use.

Referring also to FIGS. 139-145, charger 2600 is shown in various exploded, and partially exploded views. As shown, lid 2626 may include integrated shaft portions 2632, 2634 that may be at least partially received in cooperating recesses in the rear of top cover 2606 (FlG. 140). Printed circuit board 2636, including the various dectronics associated with, charger 2600, may he mounted to the rear or top cover 2606, e.g., using screws, heat- staked posts, or other suitable fastening means (FiG. 141 }. LkI closure features 2638, 2640 may be received in top cover 2606 at least partially engaging shall portions 2632, 2634. Bias members 2642, 2644 may bias iid closure features 2638, 2640 into engagement with shaft portions 2632, 2634 ( FIG. 142). Bias members 2642, 2644 may include a resilient material, such as silicone, rubber, or the like, and / or may include springs or other biasing structures. In one embodiment, shaft portions 2632. 2634 may include features (e.g.. flatted regions, etc.) that may interact with lid closure features 2638, 2640 when lid 2626 is in, or close to. a fully open and/or a fully closed position. ^'The interaction between lid closure features 2638, 2640 and shaft portions 2632, 2634 may bias Hd 2626 to the fully open and/or ihe fully closed position.

Intermediate tray 2646 may be secured Io top cover 2606 via plate 2648, which may itself be secured io top cover 2606 using screws, heat-stake- posts, adhesive, or other suitable fastening means (FlG, 143). Intermediate tray 2646 may include a recess at least partially defining the remote control assembly charging portion 2624 of charger 2600. Additionally, intermediate tray 2646 may include opening 2650 configured to at least partially receive electrical connector 2652 coupled to printed circuit board 2636 (e.g., capable of establishing an electrical connection between charger 2600 and remote control assembly 2602). Plate 2648 may include, for example, a stamped metal plate. Additionally, plate 2648 may increase the weight of charger 2600, which may allow charger 2600 to resist tipping ami/or facilitate one handed installation / removal of reusable housing assembly 802 on charger 2600. For example, the weight added by plate 2648 may allow charger to be tilted rcarwardly between about 15-30 degrees without tipping over. The degree of rearward tilt achievable before charger 2600 tips over may vary depending upon, for example, the weight of plate 2648, weight distribution, center of gravity, and the like, and may be varied according to design criteria.

Bottom cover 2654 may be coupled to top cover 2606 and/or intermediate tray 2646 via suitable fastening means, including, but not limited to, screws that may be secured to one or more of plate 2648, top cover 2606, and/or intermediate tray 2646. Sn an embodiment in which bottom cover 2654 may be coupled via screws, foot pads 2656, 2658 may be. disposed over the screws and/or screw recesses of bottom cover 2654 (FiGS. 144- 1451 Additionally, foot pads 2656, 2658 may include a relatively high friction material (e.g., υrethane foam or elastomer, rubber, or the like) that may increase, the slip resistance of charger 2600 relative to a surface upon which charger 2600 is disposed. Further, bottom cover 2654 may include opening 2660 that may allow access to reset button 2662, e.g., which may be disposed on printed circuit board 2636.

According to one embodiment, charger 2600 may utilize a mini-USB connection, e.g., which may provide power Io charger 2600 as well as allowing data communication, e.g., between charger 2600 and an external computer (such as a persona! computer, or the like), in some embodiments, charger 2600 may utilize a modified mini-USB connection, e.g., which may have the square table of the mini-USB- A plug removed to facilitate extraction of the plug from charger 2600. Accordingly, charger 2600 may allow for the charging of batteries associated with reusable housing assembly 802 and / or remote control assembly 2602, as well as communication between remote control assembly 2602, reusable housing assembly 802, and an externa! computer. Such communication may allow for, for example, downloading of logs from reusable housing assembly 802 (e.g., which may be transmitted via the internet, or other communication network, to a customer support service), reprogramrning (e.g., upgrading software, conducting diagnostics, changing program attributes, etc. ) of reusable housing assembly 802 and/ or remote control assembly 2602,

Charger 2600 may include one or more status indicators f such as LEDs) that may indicate a charging status (e.g., charging in process, charging complete), as well as one or more fault conditions. For example, a red and a green LED may be utilized in connection with one or both of reusable housing assembly 802 and remote control assembly 2602, The rςά and green LE-D may be visually perceptible through top cover 2606 of charger, via a thinned region of top cover 2606, one or more openings in top cover 2606, or the like. For example, hi one embodiment, a continuously glowing red L. K D may indicate that the reusable housing assembly is currently being charged. A continuously glowing green LED may indicate that the reusable housing assembly is completely charged. A blinking red LHD may indicate a iauff condition that may require user intervention. In addition to the blinking red LED, in some embodiments, the exact nature of the fault condition may be displayed on a display screen associated with the remote control assembly. The absence of the red and the green LED being illuminated may indicate thai no device is coupled (or is not properly coupled) to charger 2600. Various additional / alternative status indicator arrangements may be implemented depending upon design criteria and user preference. In some embodiments, charger 2600 may include one LED as a status indicator for reusable housing assembly S02 and remote control assembly 2602 may itself indicate status via & screen of/ associated with remote control assembly 2602 or other stains indicators OH remote control assembly 2602, Such other status indicators may include, but are note limited to, alarms (e.g., audio and/or vibration) and/or one or more LEDs.

In addition to the status indicators, which may indicate charging status and the occurrence of a fault condition, charger 2600 may include one or more overvoltage protection circuitry, in an embodiment, charger 2600 may include input overvoltage protection circuitry, which may actuate (e.g., via opening the circuit, etc.) in the event that the voltage provided by the USB connection is greater than a predetermined threshold. Additionally / alternatively, charger 2600 may include output overvoStage protection circuitry, which may actuate (e.g., via opening the circuit, etc.} in the event that the voltage provide to the reusable housing assembly and/or the remote control assembly is greater than a predetermined threshold. Additionally, the battery of the reusable housing assembly and/or of the remote control assembly may include an overvoltage protection, e.g., which may prevent battery damage resulting from an overvoltage event at the battery, which may not be prevented by either the input overvoltage protection circuitry' or the output overvoltage protection circuitry. According to an embodiment, the overvoltagt* protection circuitry may be hardware based, i.e., may not rely upon software. As such, the overvoltage protection circuitry may provide a higher level of safety, as it may not be subject to software faults. Additionally, according to one embodiment, the occurrence of an overvoltage event may trigger a fault condition indicator {e.g., a blinking LED, or the like).

As shown, e.g., in FKl S 34, charger 2600 may utilize a six contact electrical connector (e.g., electrical contacts 2612). According to an embodiment, the six contact electrical connector may allow for power transfer between charger 2600 and reusable housing assembly 802, Additionally, the six contact electrical connector may allow connection between a battery thermister and charging circuitry (e.g., which may allow charging to be discontinued and/or provide a fault condition indication in the event that the battery temperature is out of range}, further, the six contact electrical connector may- provide for two-way communication between reusable housing assembly 802 and charger 2600 (as well as between reusable housing assembly 802 and an external computer via charger 2600). The two-way communication may allow for, for example, reprogramming of reusable housing assembly 802 (e.g., to upgrade software), obtaining data from reusable bousing assembly 802 (e.g., such as log Information to be sent to customer service center), or the like. ^"Hie six contact electrical connector may also allow reusable housing assembly 802 (e.g., circuitry within the reusable housing assembly) to be reset, either as a result of a reset signal originating from an external computer, or as a result of reset button 2662 being actuated. Resetting reusable housing assembly 802 may be utilized for certain functions, such as programming reusable housing assembly, diagnostic purposes, resetting a malfunctioning reusable housing assembly, or the like. Additionally, the six contact electrical connector may allow charger 2600 to recognize that a reusable housing assembly has been coupled to charger 2600. Similarly, the six contact electrical connector may allow reusable housing assembly 802 to recognize that it has been coupled to charger 26(.H), The ability of reusable housing assembly 802 to recognize thai it has been coupled to charger 2600 may allow, for example, reusable housing assembly 802 to enter a low power state while charger, initiate download of logs, or the like. While the various features of the electrical connection between charger 2600 and reusable housing assembly 802 have been described, it will be appreciated that similar electrical connections may be utilized between charger 2600 and remote control assembly 2602. Additionally, while the use of a six contact electrical connector has been discussed, this is for exemplary purposes only, as the number and nature of electrical contacts and associated features may van-' depending upon user need and design criteria.

According to one embodiment, the electronics of charger 2600 may include a commercially available charging circuit, such as a model L6924D Battery Charger System with Integrated Power Switch for U-Ion/Li-Poiymer (detailed in Appendix A), available iron) STMieroeleetronics of Geneva, Switzerland. Various other battery charging circuits may be utilized depending upon, for example, batter}- characteristics, design criteria, or the like. The battery charging circuit may, for example, monitor battery voltage and temperature (e.g., via information provided by the battery thermister via the six contact electrical connector). Additionally, the battery charging circuit may adjust the batten' charging parameters based upon, for example, the battery voltage, battery temperature- predetermined charging requirements (e.g., desired charge time, etc) or the like.

Sn addition to the charging circuit, the electronics of charger 2600 may additionally include one or more processors (example of which may include, but is not limited to an MSP430 microcontroller, available from Texas Instruments Inc. of Dallas, Texas) that may control charger 2600, as well as provide for communication between an external computer and reusable bousing assembly 802 and/or remote control assembly 2602. The one or more microprocessors may control the overall operation of charger 2600. For example, the microprocessor may allow communication between reusable bousing assembly 802 and an external computer. Similarly, the microprocessor may control the operation of the status indicators (e.g., the LBDs), Various additional / alternative operations and features of charger 2600 may be controlled by the microprocessor. Referring also to FIGS. 146-148, exemplary charger circuitry that may be utilized in connection with charger 2600 is schematically illustrated. The illustrated charger circuitry is intended of illustrative purposes only, as the exact configuration may vary depending upon included features (status indicators, overvoitage protection, and the like), as well the charging circuit and microcontroller utilized. Referring also to FIGS. 149-173 various features and embodiments of chargers that may be utilized in connection with the reusable housing assembly and/or remote control assembly are depicted. Any of the depicted chargers may incorporate one or more of the above-described features.

Infusion pump therapy may include volume and time specifications. The amount of fluid dispensed together with the dispense timing may be two critical factors of infusion pump therapy. Ab discussed in detail below, the infusion pump apparatus and systems described herein may provide for a method of dispensing fluid together with a device, system and method for measuring the amount of fluid dispensed. However, in a circumstance where the calibration and precision of the measurement device calibration is critical, there may be advantages to determining any compromise in the precision of the measurement device as soon as possible. ^'Thus, there are advantages to off-board verification of volume and pumping.

As discussed above, infusion pump assembly 100 may include volume sensor assembly 148 configured to monitor the amount of fluid infused by infusion pump assembly 100. Further and as discussed above, infusion pump assembly 100 may be configured so that the volume measurements produced by volume sensor assembly 148 may be used to control through a feedback loop, the amoυm of infusible fluid that is infused into the user.

Referring also to FIGS. 90Λ-90C, there is shown one diagrammatic view and two cross-sectional views of volume sensor assembly 148. Referring also to FIGS. <H A-91 [, there is shown various isometric and diagrammatic views of volume sensor assembly 148 (which is shown to include upper housing 1400). Referring also to FIGS. 92A-92K there is shown various isometric and diagrammatic views of volume sensor assembly 148 (with upper housing 1400 removed), exposing speaker assembly 622, reference microphone 626, and printed circuit board assembly 830 Referring also to FIGS 93 A-93I, there is shown vaπous isometric and diagrammatic views of volume sensor assembly 148 (with pπnted circuit board assembly 830 removed), exposing port assembly 624 Referring also to FIGS 94A-94F, there is shown vaπous isometric and diagrammatic cross-sectional views of volume sensor assembly 148 (with printed circuit board assembly 830 removed), exposing port assembly 624 Referring also to FIG 95, there are shown an exploded view of volume sensor assembly 148, exposing upper housing 1400, speaker assembly 622, reference microphone 626, seal assembly 1404, lower housing 1402, port assembly 624, spπng diaphragm 628, and retaining πng assembly 1406 0 The following discussion concerns the design and operation of volume sensor assembly 148 (which is shown in a simplified form in FIG 96) For the following discussion, the following nomenclature may be used

DERIVATION OF THE EQUATIONS FOR VOLUME SENSOR ASSEMBLY 148: S Modeling the Acoustic Volumes

The pressure and volume of an ideal adiabatic gas may be related by

PV = K [EQ#1] where £ is a constant defined by the initial conditions of the system EQ#1 may be written in terms of a mean pressure, P, and volume, V, and a small time-dependent perturbation on top of those pressures, />(/) , v(/) as follows:

(P + p(t))(V + v(t)Y = K IEQHl Differentiating this equation may result in: PiήiV + viήγ +y(V + _V(t)J-' (P+ p(ή)v(t) = O mow which may simplify to:

«->^♦>£$ ^{V ;•}«>-. [EOM]

If the acoustic pressure levels are much less than the ambient pressure, the equation may be further simplified to:

How good is this assumption? Using the adiabatic relation it may be shown that:

Accordingly, the error in the assumption would be: error =

A very loud acoustic signal (120 dB) may correspond to pressure sine wave with amplitude of roughly 20 Pascal. Assuming air at atmospheric conditions ( γ = 1.4 , P = 101325Pa ), the resulting error is 0.03%. The conversion from dB to Pa is as follows:

where p_nf = 20 μPa .

Applying the ideal gas law, P= pRT , and substituting in for pressure may result in the following:

EQ#9 may be written in terms of the speed of sound, a = -jγRT as follows: *(O+^-*(')=o

' [EQ#10]

Acoustic impedance for a volume may be defined as follows:

,EQfII] Modeling the Acoustic Port

The acoustic port may be modeled assuming that all of the fluid in the port essentially moves as a rigid cylinder reciprocating in the axial direction. All of the fluid in the channel is assumed to travel at the same velocity, the channel is assumed to be of constant cross section, and the "end effects" resulting from the fluid entering and leaving the channel are neglected.

If we assume laminar flow friction of the formΔp = fpv , the friction force acting on the mass of fluid in the channel may be written as follows:

F = f pA²x _|EQ#12)

A second order differential equation may then be written for the dynamics of the fluid in the channel: pLAx = ApA - fpA²x _[EQ#13] or, in terms of volume flow rate:

.. /A . A v = — — v + Ap

^L P^L [E(WU]

The acoustic impedance of the channel may then be written as follows:

v A y L ) _|EQ#15]

System Transfer Functions

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

A -^ = O

⁰ |EQ*16]

² IECW18] fA A , .

^Λ ^ |EQ#19]

One equation may be eliminated if p₀ is treated as the input substituting inv_t Po pa¹

. Pa

-v_r = 0

|EQ#21]

^V'⁼T'V^A7^P| [EQ#22] Cross System Transfer Function

The relationship between the speaker volume and the variable volume may be referred to as the Cross System transfer function This transfer function may be derived from the above equations and is as follows

Po ² +2ζω_ns + aω* [ECW23] where

1 ζ =

L ²^ and I ^{1 J} [EQ#24]

Referring also to FIG 97, a bode plot of EQ#23 is shown The difficulty of this relationship is that the complex poles depend on both the vanable volume, Fj, and the reference volume, Vi Any change in the mean position of the speaker may result in an error in the estimated volume

Cross Port Transfer Function

The relationship between the two volumes on each side of the acoustic port may be referred to as the Cross Port transfer function This relationship is as follows A *² +2^ + «_n ² _1EQ#25] which is shown graphically in FIG. 98.

This relationship has the advantage that the poles are only dependent on the variable volume and not on the reference volume. It does, however, have the difficulty that the resonant peak is actually due to the inversion of the zero in the response of the reference volume pressure. Accordingly, the pressure measurement in the reference chamber will have a low amplitude in the vicinity of the resonance, potentially increasing the noise in the measurement.

Cross Speaker Transfer Function

The pressures may also be measured on each side of the speaker. This is referred to as the cross speaker transfer function:

P₁ _ V₀ s* + 2ζω_ns + ω_n ² J₀ ^{~ ~} V, s' ₊2ζω_ns ₊ aωl _(EQ#26] which is shown graphically in FIG. 99. This transfer function has a set of complex zeros in addition to the set of complex poles. p V

Looking at the limits of this transfer function: as s → 0 , — → 2 — _{; a}nd as

P_t V_{x +} V₂

Resonance Q Factor and Peak Response

The quality of the resonance is the ratio of the energy stored to the power loss multiplied by the resonant frequency. For a pure second-order system, the quality factor may be expressed as a function of the damping ratio:

²^ |EQ#27] The ratio of the peak response to the low-frequency response may also be written as a function of the damping ratio:

This may occur at the damped natural frequency:

Volume Estimation Volume Estimation using Cross-Port Phase

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

At the 90° phase point, co = o)_π ; where ω² =

V₂ L

The resonant frequency may be found on the physical system using a number of methods. A phase-lock loop may be employed to find the 90° phase point — this frequency may correspond to the natural frequency of the system. Alternatively, the resonant frequency may be calculated using the phase at any two frequencies: The phase, φ , at any given frequency will satisfy the following relation: bω ω² - < ,EQlM] where * = ^- . L

Solving for V₁ results in:

O²A

K =- ω -fωcotφ _|EQ#32] Accordingly, the ratio of the phases at two different frequencies o\ and O₂ can be used to compute the natural frequency of the system:

For computational efficiency, the actual phase does not need to be calculated. All that is needed is the ratio of the real and imaginary parts of the response ( tan φ ). Re- writing EQ#33 in terms of the variable volume results in:

1 1 L « =*—>

(O₁ - fi>,

|EQ#34]

Volume Estimation using Swept Sine The resonant frequency of the system may be estimated using swept-sine system identification. In this method, the response of the system to a sinusoidal pressure variation may be found at a number of different frequencies. This frequency response data may then used to estimate the system transfer function using linear regression.

The transfer function for the system may be expressed as a rational function of s. The general case is expressed below for a transfer function with an «'* order numerator and an m'^h order denominator. Λ^ and D are the coefficients for the numerator and denominator respectively. The equation has been normalized such that the leading coefficient in the denominator is 1.

N₁₁S" + N₁₁^s"^'1 +...+ N₀

GW = s^m + D_m ' + D '„-2* ' +... + D_a

[EQ#35] or

This equation may be re-written as follows:

Representing this summation in matrix notation resulting in the following:

where k is the number of data points collected in the swept sine. To simplify the notation, this equation may be summarized using the vectors: y ^{= C} |EQ#39] where y is k by 1 , x is k by (m+n- 1 ) and c is (m+n- 1 ) by I . The coefficients may then be found using a least square approach. The error function may be written as follows:

« = *-* ,EQ#40]

The function to be minimized is the weighted square of the error function; W is a k x k diagonal matrix.

e^τ We = / ' Wy' - (Vy^TWXc)^)T - /' WXc + c^Tx^TWXc [EQ#42]

As the center two terms are scalars, the transpose may be neglected. e^TWe = y^TWy-2y^TWXc+c^Tx^TWXc _ieQM3] de^TWe

- = -lX^TWy + 2X¹ WXc = 0 d° [EQ#44] c = (x^TWX)^' ^"l' X X^T' W Wyv

[EQ#4S] It may be necessary to use the complex transpose in all of these cases. This approach may result in complex coefficients, but the process may be modified to ensure that all the coefficients are real. The least-square minimization may be modified to give only real coefficients if the error function is changed to be e^TWe = Re(y-Xcf WRe(y-Xc) + lm(y-Xcf W \m{y-Xc) ^^ Accordingly, the coefficients may be found with the relation:

C = (Re(Xf WRe{X) + lm(X)^T WM(X)J' (Re(Xf WRe(y)+lm(X)^T Wbn(yj}

[EQ#47]

Solution for a 2nd Order System For a system with a 0^th order numerator and a second order denominator as shown in the transfer function:

The coefficients in this transfer function may be found based on the expression found in the previous section: C = (Re(Xf W Re(X) + lm(xf WIm(X)J' {Ke(X)^τ W Re(y)+lm(X)^T W ]m(_yf)

[EQ#49] where:

To simplify the algorithm, we may combine some of terms: c = D 2> Ig_Qg₅₁] where:

D = Re(X)^r WRe(X)₊Im(Xf Wλm(X) ^^ b = Rc(xf wRe(y) + Im(xf wim(y) ^^

To find an expression for D in terms of the complex response vector G and the natural frequency J =jω, X may be split into its real and imaginary parts:

1 ω_k Im(G₁ ) -Re(G₁ ) 0 -^ Re(G₁ ) -Im(G₁ )

Re(X) = Im(X) = 1 ω_k Im(G₄ ) -Re(G₄ ) 0 -ω_k Re(G₄ ) -Im(Gj

[EQ#54]

The real and imaginary portions of the expression for D above may then become:

Re(X)VRe(X) ) Re(G, )dϋ, Re(G, )²

at, ∑ w, Im(G, ) Re(G, )ω, «, ∑ W₁ Im(G₁)²

IECWS61

Combining these terms results in the final expression for the D matrix, which may contain only real values. ∑^w. ∑w, Im(G, )«, -∑ W₁ Re(G₁)

D = w, Im(G- )ω, ∑ w, (Re(G,)² + Im(G, )²)a)²

-∑w, Re(G,) Xw, (Re(G,)² + Im(G₁)²)

[EQ#57]

The same approach may be taken to find an expression for the b vector in terms of G and ω . The real and imaginary parts of y are as follows:

Combining the real and imaginary parts results in the expression for the b vector as follows:

b = Re(X)^T WRe(y) + lm(X)^T Wim(y) =

Xw₁ (Re(G₁)² +Im(G₁ f )ω?

|EQ#59]

The next step is to invert the D matrix. The matrix is symmetric and positive- definite so the number of computations needed to find the inverse will be reduced from the general 3x3 _case Jj₁₆ general expression for a matrix inverse is:

D-' = I i. / r>.\

"JK¹ det(D)

IfD is expressed as follows:

then the adjugate matrix may be written as follows:

Due to symmetry, only the upper diagonal matrix may need to be calculated. The Determinant may then be computed in terms of the adjugate matrix values, taking advantage of the zero elements in the original array: det(D) = α₁₂rf₁₂ +α₂₂</_{22 (EQ#K]} Finally, the inverse of D may be written as follows:

Z) ¹ = - adj(D) det(D) IECWM]

Since we are trying to solve: c = D-'b = - -aaadjjy{υDp)b det(D) |EQ#65] then:

The final step is to get a quantitative assessment of how well the data fits the model. Accordingly, the original expression for the error is as follows: e^TIVe = Re(y-Xcf WRe(y-Xc) +

W \m(y-Xc) _EQ#6 This may be expressed in terms of the D matrix and the b and c vectors as follows: e^TWe = h-2c^Tb+c^TDc _|EQ#ββ] where:

U = Y₁W₁ (Re(G,)² +Im(G,)² )ω?

|EQ#70]

The model fit error may also be used to detect sensor failures.

Alternate Solution for a 2nd Order System

,^™ ₊D_m,,"'-' + D_m-/"-² + -+ Do _1EQ#71] or

This equation may be re-written as follows:

t=0 t=o |EQ#73]

Putting this summation into matrix notation results in the following:

For a system with a 0^th order numerator and a second order denominator as shown in the transfer function:

The coefficients in this transfer function may be found based on the expression found in the previous section:

fVRe(X) + bn(xf WIm(X)J¹ (Re(xf WRe(y) + lm(xf Wka(y)}

[EO#7β] where

|EQ#77] To simplify the algorithm, some terms may be combined: c = D^''b _|EQ#78] where:

D = Re(Xf WRe(X)₊Im(Xf Wϊm(X) _mnj9j b = Re(Xf WRe(y) + lm(Xf Wlm(y) ^^

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

The real and imaginary portions of the expression for D above may then become.

£ W₁ Im(G,)<³ -£w, Re(G₁X

Re(A-)VRe(A-) = ∑w, Im(G₁X³ ∑ W₁ Im(G,)²^² -^w₁ Im(G,) Re(G₁)W,^"3

-∑ w, Re(G₁ X" -∑ W₁ Im(G, ) Re(G, χ³ ∑ W₁ Re(G₁ f a?

Im(G,) Re(G₁X³ ^-W₁ Im(G₁)²V

[EQ#β4]

Combining these terms results in the final expression for the D matrix, which may contain only real values.

ωf

The same approach may be taken to find an expression for the b vector in terms of G and ω . The real and imaginary parts of y areas follows:

Combining the real and imaginary parts results in the expression for the b vector as follows: b = Re(X)^T WRe(y) + lm(X)^T

Implementing Acoustic Volume Sensing

Collecting the Frequency Response Data and Computing the Complex Response

To implement volume sensor assembly 148, volume sensor assembly 148 should determine the relative response of reference microphone 626 and invariable volume microphone 630 to the acoustic wave set up by speaker assembly 622. This may be accomplished by driving speaker assembly 622 with a sinusoidal output at a known frequency; the complex response of microphones 626, 630 may then be found at that driving frequency. Finally, the relative response of microphones 626, 630 may be found and corrected for alternating sampling by e.g., an analog-to-digital convertor (i.e., ADC). Additionally, the total signal variance may be computed and compared to the variance of pure tone extracted using the discrete Fourier transform (i.e., DFT). This may result in a measure of how much of the signal power comes from noise sources or distortion. This value may then be used to reject and repeat bad measurements.

Computing the Discrete Fourier Transform

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

A DFT may be performed on the data at the integer value corresponding to the driven frequency of the speaker. The general expression for the first harmonic of a DFT is as follows:

2 « x_t = > x_ne

|EQ#88] The product AW may be the total number of points and the factor of two may be added such that the resulting real and imaginary portions of the answer match the amplitude of the sine wave x, = /-e(x_t)cos — kn +«»(jr_t)sin — kn This real part of this expression may be as follows

We may take advantage of the symmetry of the cosine function to reduce the number of computations needed to compute the DFT The expression above may be equivalent to

Similarly, for the imaginary portion of the equation

which may be expressed as follows i^wW=~^ L(^"V)⁺⁴|^sin(_l7")[(^x»-V»)⁺(v₊»-^)] J (EQ*»l The variance of this signal may be calculated as follows

The maximum possible value of the real and imaginary portions ofx may be 2", which corresponds to half the AD range The maximum value of the tone variance may be 2²¹, half the square of the AD range

Computing the Signal Variance

The pseudo-vaπance of the signal may be calculated using the following relation

The result may be in the units of AD counts squared It may only be the "pseudo- variance" because the signal has been averaged over M periods before the variance is calculated over the Λ' samples in the "averaged" period This may be a useful metric, however, for finding if the "averaged" signal looks like a sinusoid at the expected frequency This may be done by comparing the total signal variance to that of the sinusoid found in the discrete Fouπer transform

The summation may be on the order of ∑x² = 0(NM²I¹') for a 12-bit ADC If N < 2⁷ = 128 and M < 2⁶ = 64 , then the summation will be less than 2⁴¹ and may be stored in a 64-bit integer The maximum possible value of the variance may result if the ADC oscillated between a value of 0 and 2¹² on each consecutive sample This may result in a peak variance of — (2¹² ) = 2²² so the result may be stored at a maximum of a 1/2⁹ resolution in a signed 32-bit integer

Computing the Relative Microphone Response

The relative response (G) of microphones 626, 630 may be computed from the complex response of the individual microphones

^Xref ^Xr "efI ^X -Vnf |EQ#96]

The denominator of either expression may be expressed in terms of the reference tone variance computed in the previous section as follows

Re(_V)² + Im(_V)² = 2< _iEQ#99]

Correcting for A/D Skew

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 The result may be a phase offset between two microphones 626, 630 of — To correct for this phase offset, a complex rotation may

N be applied to the relative frequency response computed in the previous section

Reference Models

Second and Higher Order Models

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

The system of equations describing the three-chamber configuration may be as follows:

A+^-(*. -*,»)=o

|EQ#101]

pa

[EQ#104]

Putting these equations into state-space results in the following:

the frequency response of which may be represented graphically in the Bode diagram shown in FIG. 101 and which may also be written in transfer function form:

Expanding the denominator results in the following

A bubble underneath the diaphragm material in the vaπable volume will follow the same dynamic equations as a leakage path In this case, the diaphragm material may act as the resonant mass rather than the leakage port Accordingly, the equation may be as follows

IHX = AP^ -V _|EQ#109] wherein m is the mass of the diaphragm, A is the cross sectional area of the diaphragm that can resonate, and b_m is the mechanical damping EQ#106 may be written in terms of the volume flow rate b _A A¹ v = v + Δp — m^m [EQ#110] wherein the volume of the air bubble is V3 If the bubble volume is substantially smaller than the acoustic volume V3 « V2 than the transfer function may be simplified to

^Λ (s² + V + <4)[ *² +*_,* + *£,[ l + £

|EQ#111]

Second Order with Time Delay

The volume sensor assembly 148 equations derived above assume that the pressure is the same everywhere in the acoustic volume This is only an approximation, as there are time delays associated with the propagation of the sound waves through the volume This situation may look like a time delay or a time advance based on the relative position of the microphone and speakers

A time delay may be expressed in the Laplace domain as G(s) = e ^&n _|EWm2) which makes for a non-linear set of equations. However, a first-order Pade approximation of the time delay may be used as follows:

which is shown graphically in FIG. 102.

Three Chamber Volume Estimation

Volume sensor assembly 148 may also be configured using a third reference volume (e.g., reference volume 1508; FIG. 103) connected with a separate resonant port (e.g., port 1510; FIG. 103). This configuration may allow for temperature-independent volume estimation.

The system of equations describing the three-chamber configuration are as follows:

A +-^-(^i:'t -v_rl2 -v_f,₃) = o

¹ |EQ#114] pa¹

² [EQ#115]

• +T?-(A -Λ)

P¹V [EQ#11β]

Using these equations and solving for the transfer function across each of the resonant ports results in the following:

where

|_EQ#121]

where 1 O¹A₁, κ' ^³ and ^^^ω«a [EQ#122] The volume of volume sensor chamber 620 may be estimated using the ratio of the natural frequency of the two resonant ports as follows

EQ# 120 illustrates that the volume of volume sensor chamber 620 may be proportional to reference volume 1508 The ratio of these two volumes (in the ideal model) may only depend on the geometry of the resonant port (e g , port 1510, FIG 103) and has no dependence upon temperature

Exponential Volume Model

Assume the flow out through the flow resistance has the following form

V = fk τ [EQ#124]

Assuming a fixed input flow rate from the pump chamber, the volume of volume sensor chamber 620 is based upon the following differential equation y V = V - V = V - °" τ |EQ#125] which gives the following solution assuming a zero initial volume

Accordingly, the output flow rate flows

The volume delivered during the pump phase may be wπtten

K-, = K.I '-r| 1-e

|EQ#128)

Device Calibration

The model fit 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 to be expressed as follows:

₂ O¹A 1 cor =

^{L V1} |EQ#1-9]

The speed of sound will vary with temperature, so it may be useful to split out the temperature effects. ω: = ^L

L V 2 [EQ#130]

The volume may then be expressed as a function of the measured resonant frequency and the temperature: v -c-L ω« [ECW131] vRA Where c is the calibration constant C = - —

L

Implementation Details End Effects

The air resonating in the port (e.g., port assembly 624) may extend out into the acoustic volumes at the end of each oscillation. The distance the air extends may be estimated based on the fundamental volume sensor assembly equations. For any given acoustic volume, the distance the air extends into the volume may be expressed as a function of the pressure and port cross-sectional area:

V

P° ^A |EQ#132) If we assume the following values:

K = = 2288..88x^χl: 0^→L _|EQ#133]

a = 340-a |EQ#135J d = 0.5 mm ₍EQ#I36] P = I -Pa (Approximately 100 dB) [EQ#137]

Accordingly, the air will extend roughly 1.9 mm in to the acoustic chamber.

Sizing Vl (i.e., the fixed volume) relative to V2 (i.e., the variable volume) Sizing V_\ (e.g., fixed volume 1500) may require trading off acoustic volume with the relative position of the poles and zeros in the transfer function. The transfer function for both V] and V₂ (e.g., variable volume 1502) are shown below relative to the volume displacement of speaker assembly 622. pa „2 „2

V_x s² + 2ζω_ns ₊ aω² _|EQjm8] p, _ pa² s² + 2ζω_πs + aω_t

V₁ s* ₊2ζω,s ₊ ω_n ² _|EQ#139] where

^{" L V}^ ²ⁱ"^» and I ^V* > rmm As V_\ is increased the gain may decrease and the speaker may be driven at a higher amplitude to get the same sound pressure level. However, increasing V_\ may also have the benefit of moving the complex zeros in the pi transfer function toward the complex poles. In the limiting case where V₁ -> ∞ , a → 1 and you have pole-zero cancellation and a flat response. Increasing V\, therefore, may have the benefit of reducing both the resonance and the notch in thepi transfer function, and moving thep2 poles toward ω_n ; resulting in a lower sensitivity to measurement error when calculating the p^px transfer function. FIG. 104 is a graphical representation of: ϋ

^V* |EQ#141]

FIG. 105 is a graphical representation of

^V* |EQ#142] Aliasing

Higher frequencies may alias down to the frequency of interest, wherein the aliased frequency may be expressed as follows:

/ = |/. -n/,| _(EQ#143] where f_s is the sampling frequency, f_π is the frequency of the noise source, n is a positive integer, and/ is the aliased frequency of the noise source.

The demodulation routine may effectively filter out noise except at the specific frequency of the demodulation. If the sample frequency is set dynamically to be a fixed multiple of the demodulation frequency, then the frequency of the noise that can alias down to the demodulation frequency may be a fixed set of harmonics of that fundamental frequency.

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

L I I _L _!_ _!_ _!_ f nβ + Ϋ nβ-\ 7 '9' 15 ' 17 '23 ' 25 ' |EQ#144] where β = — = 8. For β = 16 , the following series would result:

/. _ π i i >

/ U⁵ ' ¹⁷ ' 31 ' 33 " ; _|E<W1,5,

Performance

Sensitivity to Temperature

The sensitivity to temperature may be split into a gain change and a noise change. If the temperature is off by a factor of dT, the resulting gain error may be:

^ «t ) ,EQ#147, Accordingly, if the same temperature is used for both sine sweeps, any error in the temperature measurement may look like a gain change to the system.

<w ^{= 1}- 71_r aaual [EQ#148]

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

The measurement, however, may be more susceptible to noise in the temperature measurement. A temperature change during the differential sine sweeps may result in an error that looks more like an offset rather than a gain change:

(O [EQ#149]

Accordingly, if the measurement varies by 0.1 K during the two measurement sine sweeps, the difference may be 0.012 uL. Therefore, it may be better to use a consistent temperature estimate for each delivery rather than taking a separate temperature measurement for each sine sweep (as shown in FIG 107)

The LM73 temperature sensor has a published accuracy of +/- 1° C and a resolution of 0 03 C Further, the LM73 temperature sensor seems to consistently have a startup transient of about 03° C that takes about five sine sweeps to level out (as shown in FIG 108)

Since the above-descπbed infusion pump assemblies (e g , infusion pump assembly 100, 100', 400, 500) provides discrete deliveries of infusible fluid, the above-described infusion pump assemblies may be modeled entirely in the discrete domain (in the manner shown in FIG 109), which may be reduced to the following

z ~ ^l |EQ#150]

A discrete-time PI regulator may perform according to the following

^ '< ^{Z 1} J |EQ#151]

The AVS system described above works by comparing the acoustic response in fixed volume 1500 and vaπable volume 1502 to a speaker driven input and extracting the volume of the vaπable volume 1502 As such, there is a microphone in contact with each of these separate volumes (e g , microphones 626, 630) The response of vaπable volume microphone 630 may also be used in a more gross manner to detect the presence or absence of disposable housing assembly 114 Specifically, if disposable housing assembly 114 is not attached to (i e , positioned proximate) vaπable volume 1502, essentially no acoustic response to the speaker dπven input should be sensed The response of fixed volume 1500, however, should remain tied to the speaker input Thus, the microphone data may be used to determine whether disposable housing assembly 114 by simply ensuπng that both microphones exhibit an acoustic response In the event that microphone 626 (i e , the microphone positioned proximate fixed volume 1500) exhibits an acoustic response and microphone 630 (i e , the microphone positioned proximate vaπable volume 1502) does not exhibit an acoustic response, it may be reasonably concluded that disposable housing assembly 114 is not attached to reusable housing assembly 102 It should be noted that a failure of vaπable volume microphone 630 may also appear to be indicative of disposable housing assembly 114 not being attached, as the failure of vaπable volume microphone 630 may result in a mid-range reading that is nearly indistinguishable from the microphone response expected when disposable housing assembly 1 14 is not attached.

For the following discussion, the following nomenclature may be used:

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

σmax = ^ a_max(f) |EQ#152]

and the difference between these two summations may be simplified as follows: 6 = σmax — σmin

[EQ#154]

While δ may be divided by the number of sine sweeps to get the average minimum / maximum difference for the sine sweep (which is then compared to a threshold), the threshold may equivalently be multiplied by N for computational efficiency. Accordingly, the basic disposable detection algorithm may be defined as follows: φ_t il δ_var > N * T

I o if δvar < N * T& dre/ > N • T

|EQ#155] The additional condition that the maximum / minimum difference be greater than the threshold is a check performed to ensure that a failed speaker is not the cause of the acoustic response received. This algorithm may be repeated for any sine-sweep, thus allowing a detachment of disposable housing assembly 114 to be sensed within e.g., at most two consecutive sweeps (i.e., in the worst case scenario in which disposable housing assembly 114 is removed during the second half of an in-progress sine sweep).

Thresholding for the above-described algorithm may be based entirely on numerical evidence. For example, examination of typical minimum / maximum response differences may show that no individual difference is ever less than five hundred ADC counts. Accordingly, all data examined while disposable housing assembly 114 is detached from reusable housing assembly 102 may show that all minimum / maximum response differences as being well under five hundred ADC counts. Thus, the threshold for δ may be set at T=500.

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

While volume sensor assembly 148 is described above as utilizing a port (e.g., port assembly 624) as a resonator, (his is for illustrative purposes only, as other configurations are possible and are considered to be within the scope of this disclosure. For example, a solid mass (not shown) may be suspended within port assembly 624 and may function as a resonator for volume sensor assembly 148. Specifically, the mass (not shown) for the resonator may be suspended on a diaphragm (not shown) spanning port assembly 624. Alternatively, the diaphragm itself (not shown) may act as the mass for the resonator. The natural frequency of volume sensor assembly 148 may be a function of the volume of variable volume 1502. Accordingly, if the natural frequency of volume sensor assembly 148 can be measured, the volume of variable volume 1502 may be calculated.

The natural frequency of volume sensor assembly 148 may be measured in a number of different ways. For example, a time-varying force may be applied to the diaphragm (not shown) and the relationship between that force and the motion of the diaphragm (not shown) may be used to estimate the natural frequency of volume sensor assembly 148. Alternately 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.

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

• speaker assembly 622 may create a time-varying pressure within fixed volume 1500,

• the resonant mass (not shown) may be a piezoelectric material responding to a time- varying voltage / current, and

• the resonant mass (not shown) may be a voice coil responding to a time-varying voltage / current

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

• measuring the pressure in the fixed volume,

• the resonant mass (not shown) may be a piezoelectric material, and

• a strain gauge may be connected to the diaphragm (not shown) or other structural member supporting the resonant mass (not shown)

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

• via piezoelectric sensor,

• via capacitive sensor,

• via optical sensor,

• via Hall-effect sensor,

• via a potentiometer (time varying impedance) sensor,

• via an inductive type sensor, and

• via a linear variable differential transformer (LVDT)

Further, the resonant mass (not shown) may be integral to either the force or displacement type sensor (i e the resonant mass (not shown) may be made of piezoelectric material)

The application of force and measurement of displacement may be accomplished by a single device For example, a piezoelectric material may be used for the resonant mass (not shown) and a time-varying voltage / current may be applied to the piezoelectric mateπal to create a time-varying force The resulting voltage / current applied to the piezoelectric material may be measured and the transfer function between the two used to estimate the natural frequency of volume sensor assembly 148

As discussed above, the resonant frequency of volume sensor assembly 148 may be estimated using swept-sine system identification Specifically, the above-described model fit may allow the resonant frequency of the port assembly to be extracted from the sine sweep data, which may then be used to determine the delivered volume The ideal relationship between the resonant frequency and the delivered volume may be expressed as follows

₂ O¹A 1

^L ^ (EOM261

The speed of sound will vary with temperature, so it may be useful to split out the temperature effects

I V

^L * 2 |EQ#126]

The volume may then be expressed as a function of the measured resonant frequency and the temperature

T V - C—

² ~ ω "² |EQ#1-7]

YRA

Where c is the calibration constant C =

L

Infusion pump assembly 100 may then compare this calculated volume V₂ (1 e , representative of the actual volume of infusible fluid delivered to the user) to the target volume (1 e , representative of the quantity of fluid that was supposed to be delivered to the user) For example, assume that infusion pump assembly 100 was to deliver a 0 100 unit basal dose of infusible fluid to the user every thirty minutes Further, assume that upon effectuating such a delivery, volume sensor assembly 148 indicates a calculated volume V2 (1 e , representative of the actual volume of infusible fluid delivered to the user) of 0 095 units of infusible fluid

When calculating volume V₂, infusion pump assembly 100 may first determine the volume of fluid within volume sensor chamber 620 prior to the administration of the dose of infusible fluid and may subsequently determine the volume of fluid within volume sensor chamber 620 after the administration of the dose of infusible fluid, wherein the difference of those two measurements is indicative of V2 (1 e , the actual volume of infusible fluid delivered to the user) Accordingly, V₂ is a differential measurement

V2 may be the total air space over the diaphragm in the variable volume chamber The actual fluid delivery to the patient may be the difference in V2 from when the chamber was full to after the measurement valve was opened and the chamber was emptied V2 may not directly be the delivered volume For example, the air volume may be measured and a series of differential measurements may be taken For occlusion, an empty measurement may be taken, the chamber may be filed, a mil measurement may be taken, and then a final measurement may be taken after the exit valve is open Accordingly, the difference between the first and second measurement may be the amount pumped and the difference between the second and third is the amount delivered to the patient

Accordingly, electrical control assembly 110 may determine that the infusible fluid delivered is 0005 units under what was called for In response to this determination, electrical control assembly 110 may provide the appropriate signal to mechanical control assembly 104 so that any additional necessary dosage may be pumped Alternatively, electrical control assembly 110 may provide the appropriate signal to mechanical control assembly 104 so that the additional dosage may be dispensed with the next dosage Accordingly, during administration of the next 0 100 unit dose of the infusible fluid, the output command for the pump may be modified based on the difference between the target and amount delivered

Referring also to FIG 110, there is shown one particular implementation of a control system for controlling the quantity of infusible fluid currently being infused based, at least in part, on the quantity of infusible fluid previously administered Specifically and continuing with the above-stated example, assume for illustrative purposes that electrical control assembly 110 calls for the delivery of a 0 100 unit dose of the infusible fluid to the user Accordingly, electrical control assembly 110 may provide a target differential volume signal 1600 (which identifies a partial basal dose of 0010 units of infusible fluid per cycle of shape memory actuator 112) to volume controller 1602 Accordingly and in this particular example, shape memory actuator 112 may need to be cycled ten times in order to achieve the desired basal dose of 0 100 units of infusible fluid (1 e , 10 cycles x 0010 units per cycle = 0 100 units) Volume controller 1602 in turn may provide "on-time" signal 1606 to SMA (1 e , shape memory actuator) controller 1608 Also provided to SMA controller 1608 is battery voltage signal 1610 Specifically, shape-memory actuator 112 may be controlled by varying the amount of thermal energy (e g , joules) applied to shape-memory actuator 112 Accordingly, if the voltage level of battery 606 is reduced, the quantity of joules applied to shape-memory actuator 112 may also be reduced for a defined period of time Conversely, if the voltage level of battery 606 is increased, the quantity of joules applied to shape memory actuator 112 may also be increased for a defined period of time Therefore, by monitonng the voltage level of battery 606 (via battery voltage signal 1610), the type of signal applied to shape-memory actuator 112 may be vaπed to ensure that the appropriate quantity of thermal energy is applied to shape-memory actuator 112 regardless of the battery voltage level

SMA controller 1608 may process "on-time" signal 1606 and battery voltage signal 1610 to determine the appropπate SMA drive signal 1612 to apply to shape-memory actuator 112 One example of SMA drive signal 1612 may be a seπes of binary pulses in which the amplitude of SMA drive signal 1612 essentially controls the stroke length of shape-memory actuator 112 (and therefore pump assembly 106) and the duty cycle of SMA drive signal 1612 essentially controls the stroke rate of shape-memory actuator 112 (and therefore pump assembly 106) Further, since SMA drive signal 1612 is indicative of a differential volume (i e , the volume infused during each cycle of shape memory actuator 112), SMA dπve signal 1612 may be integrated by discrete time integrator 1614 to generate volume signal 1616 which may be indicative of the total quantity of infusible fluid infused during a plurality of cycles of shape memory actuator 112 For example, since (as discussed above) it may take ten cycles of shape memory actuator 112 (at 0010 units per cycle) to infuse 0 100 units of infusible fluid, discrete time integrator 1614 may integrate SMA dπve signal 1612 over these ten cycles to determine the total quantity infused of infusible fluid (as represented by volume signal 1616)

SMA dπve signal 1612 may actuate pump assembly 106 for e g one cycle, resulting in the filling of volume sensor chamber 620 included within volume sensor assembly 148 Infusion pump assembly 100 may then make a first measurement of the quantity of fluid included within volume sensor chamber 620 (as discussed above) Further and as discussed above, measurement valve assembly 610 may be subsequently energized, 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 make a measurement of the quantity of fluid included within volume sensor chamber 620 (as described above) and use those two measurements to determine V₂ (1 e , the actual volume of infusible fluid delivered to the user during the current cycle of shape memory actuator 112) Once determined, V₂ (1 e , as represented by signal 1618) may be provided (1 e , fed back) to volume controller 1602 for comparison to the earlier-received target differential volume

Continuing with the above-stated example in which the differential target volume was 0010 units of infusible fluid, assume that V₂ (1 e , as represented by signal 1618) identifies 0009 units of infusible fluid as having been delivered to the user Accordingly, infusion pump assembly 100 may increase the next differential target volume to 0011 units to offset the earlier 0001 unit shortage Accordingly and as discussed above, the amplitude and/or duty cycle of SMA drive signal 1612 may be increased when delivering the next basal dose of the infusible fluid to the user This process may be repeated for the remaining nine cycles of shape memory actuator 112 (as discussed above) and discrete time integrator 1614 may continue to integrate SMA drive signal 1612 (to generate volume signal 1616) which may define the total quantity of infusible fluid delivered to the user

Referring also to FIG 111, there is shown one possible embodiment of volume controller 1602 In this particular implementation, volume controller 1602 may include PI (proportional- integrator) controller 1650 Volume controller 1602 may include feed forward controller 1652 for setting an initial "guess" concerning "on-time" signal 1606 For example, for the situation described above in which target differential volume signal 1600 identifies a partial basal dose of 0010 units of infusible fluid per cycle of shape memory actuator 112, feed forward controller 1652 may define an initial "on-time" of e g , one millisecond Feed forward controller 1652 may include e g , a lookup table that define an initial "on-time" that is based, at least in part, upon target differential volume signal 1600 Volume controller 1602 may further include discrete time integrator 1654 for integrating target differential volume signal 1600 and discrete time integrator 1656 for integrating V₂ (1 e , as represented by signal 1618)

Referring also to FIG 112, there is shown one possible embodiment of feed forward controller 1652 In this particular implementation, feed forward controller 1652 may define a constant value signal 1658 and may include amplifier 1660 (e g , a unity gain amplifier), the output of which may be summed with constant value signal 1658 at summing node 1662 The resulting summed signal (1 e , signal 1664) may be provided to as an input signal to e g , lookup table 1666, which may be processed to generate the output signal of feed forward controller 1652 As discussed above, pump assembly 106 may be controlled by shape memory actuator 112 Further and as discussed above, SMA controller 1608 may process "on-time" signal 1606 and battery voltage signal 1610 to determine the appropπate SMA drive signal 1612 to apply to shape-memory actuator 112

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

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

When applying power to shape-memory actuator 112, voltage may be applied for a fixed amount of time and a) at a fixed duty cycle with an unregulated voltage, b) at a fixed duty cycle with a regulated voltage, c) at a vaπable duty cycle based upon a measured current value, d) at a variable duty cycle based upon a measured voltage value, and e) at a variable duty cycle based upon the square of a measured voltage value Alternatively, voltage may be applied to shape- memory actuator 112 for a variable amount of time based upon a measured impedance

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

When applying a regulated voltage for a fixed amount of time at a fixed duty cycle, 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

When applying an unregulated voltage at a variable duty cycle based upon a measured current value, the actual current applied to shape-memory actuator 112 may be measured and the duty cycle may be adjusted during the actuation of shape-memory actuator 112 to maintain the correct mean current

When applying an unregulated voltage at a vaπable duty cycle based upon a measured voltage value, the actual voltage applied to shape-memory actuator 112 may be measured and the duty cycle may be adjusted during the actuation of shape-memory actuator 112 to maintain the correct mean voltage

When applying an unregulated voltage at a variable duty cycle based upon the square of a measured voltage value, the actual voltage applied to shape-memory actuator 112 may be measured and the duty cycle may be adjusted during the actuation of shape-memory actuator 112 to maintain the square of the voltage at a level required to provide the desired level of power to shape-memory actuator 112 (based upon the impedance of shape-memory actuator 112)

Referring also to FIG 114A-114B, there is shown other implementations of SMA controller 1608 Specifically, FIG 114A is an electrical schematic that includes a microprocessor and various control loops that may be configured to provide a PWM signal that may open and close the switch assembly The switch assembly may control the current that is allowed to flow through the shape memory actuator The battery may provide the current to the shape memory actuator Further, 114B discloses a volume controller and an inner shape memory actuator controller The shape memory actuator controller may provide a PWM signal to the pump, which may be modified based on the battery voltage This may occur for a fixed ontime, the result being a volume that may be measured by volume sensor assembly 148 and fed back into the volume controller In our preferred embodiment, we vary the duty cycle based on the measured battery voltage to give you approximately consistent power We adjust the duty cycle to compensate for a lower battery voltage Battery voltage may change for two reasons 1 ) as batteries are discharged, the voltage slowly decreases, and 2) when you apply a load to a battery it has an internal impedence so its voltage dips This is something that happens in any type of system, and we compensate for that by adjusting the duty cycle, thus mitigating the lower or varying battery voltage Battery voltage may be measured by the microprocessor In other systems 1 ) voltage may be regulated (put a regulator to maintain the voltage at a steady voltage), 2) feedback based on something else (i e , speed or position of a motor, not necessarily measuπng the battery voltage)

Other configurations may be utilized to control the shape memory actuator For example A) the shape memory actuator may be controlled at fixed duty cycle with unregulated voltage As voltage varies, the repeatablity of heating the shape memory actuator is reduced B) a fixed duty cycle, regulated voltage may be utilized which compensate for changes in battery voltage However, regulate the voltage down is less efficient due to energy of energy C) the duty cycle may be varied based on changes in current (which may required more complicated measurement circuitry D) The duty cycle may be varied based on measured voltage E) The duty cycle may be varied based upon the square of the current or the square of the voltage divided by resistance F) the voltage may be applied for a variable amount of time based on the measured impedance (e g , may measure impedance using Wheatstone gauge (not shown)) The impedance of the shape memory actuator may be correlated to strain (i e , may correlate how much the SMA moves based on its impedance)

Refemng also to FIG 115 and as discussed above, to enhance the safety of infusion pump assembly 100, electrical control assembly 110 may include two separate and distinct microprocessors, namely supervisor processor 1800 and command processor 1802 Specifically, command processor 1802 may perform the functions discussed above (e g , generating SMA dπve signal 1612) and may control relay / switch assemblies 1804, 1806 that control the functionality of (in this example) shape memory actuators 112, 632 (respectively) Command processor 1802 may receive feedback from signal conditioner 1808 concerning the condition (e g , voltage level) of the voltage signal applied to shape memory actuators 112, 632 Command processor 1800 may control relay / switch assembly 1810 independently of relay / switch assemblies 1804, 1806 Accordingly, when an infusion event is desired, both of supervisor processor 1800 and command processor 1802 must agree that the infusion event is proper and must both actuate their respective relays / switches In the event that either of supervisor processor 1800 and command processor 1802 fails to actuate their respective relays / switches, the infusion event will not occur Accordingly through the use of supervisor processor 1800 and command processor 1802 and the cooperation and concurrence that must occur, the safety of infusion pump assembly 100 is enhanced

The supervisor processor may prevent the command processor from delivering when it is not supposed and also may alarm if the command processor does not deliver when it should be delivering The supervisor processor may deactivate the relay / switch assembly if the command processor actuates the wrong switch, or if the command processor it tries to apply power for too long

The supervisor processor may redundantly doing calculations for how much insulin should be delivered (i e , double checking the calculations of the command processor) Command processor may decide the delivery schedule, and the supervisor processor may redundantly check those calculations

Supervisor also redundantly holds the profiles (delivery profiles) m RAM, so the command processor may be doing the correct calculations, but if is has bad RAM, would cause the command to come up with the wrong result The Supervisor uses its local copy of the basal profile, etc , to double check

Supervisor can double check AVS measurements, looks at the AVS calculations and applies safety checks Every time AVS measurement is taken, it double checks

Refemng also to FIG 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 the voltages (Vl & V2 respectively) sensed at distal ends of e g , shape memory actuator 112 The value of voltages Vl & V2 in combination with the knowledge of the signals applied to relay / switch assemblies 1804, 1810 may allow for diagnostics to be performed on various components of the circuit shown in FIG 116 (in a manner similar to that shown in illustrative diagnostic table 1816)

As discussed above and as illustrated in FIGS 115-116, to enhance the safety of infusion pump assembly 100, electrical control assembly 110 may include a plurality of microprocessors (e g , supervisor processor 1800 and command processor 1802), each of which may be required to interact and concur in order to effectuate the delivery of a dose of the infusible fluid In the event that the microprocessors fail to interact / concur, the delivery of the dose of infusible fluid may fail and one or more alarms may be triggered, thus enhancing the safety and reliability of infusion pump assembly 100

A master alarm may be utilized that tracks the volume error over time Accordingly, if the sum of the errors becomes too large, the master alarm may be initiated, indicating that something may be wrong with the system Accordingly, the master alarm may be indicative of a total volume comparison being performed and a discrepancy being noticed A typical value of the discrepancy required to initiate the master alarm may be 1 00 milliliters The master alarm may monitor the sum in a leaky fashion (i e , Inaccuracies have a time horizon)

Referring also to FIGS 1 17A-117B, there is shown one such illustrative example of such interaction amongst multiple microprocessors duπng the delivery of a dose of the 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 the "pump power request" message, supervisor processor 1800 may e g , energize 1906 relay / switch 1810 (thus energizing shape memory actuator 112) and may send 1908 a "pump power on" message to command processor 1802 Upon receiving 1910 the "pump power on" message, command processor 1802 may actuate 1912 e g , pump assembly 106 (by energizing relay / switch 1804), during which time supervisor processor 1800 may monitor 1914 the actuation of e g , pump assembly 106

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 deenergize 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 quantity of infusible fluid pumped by pump assembly 106 This may be accomplished by measuring the current quantity of fluid within volume sensor chamber 620 and comparing it with the quantity determined above (in step 1900) Once determined 1924, command processor 1802 may provide 1926 a "valve open power request" message to supervisor processor 1800 Upon receiving 1928 the "valve open power request" message, supervisor processor 1800 may energize 1930 relay / switch 1810 (thus energizing shape memory actuator 632) and may send 1932 a "valve open power on" message to command processor 1802 Upon receiving 1934 the "valve open power on" message, command processor 1802 may actuate 1936 e g , measurement valve assembly 610 (by energizing relay / switch 1806), duπng which time supervisor processor 1800 may monitor 1938 the actuation of e g , measurement valve assembly 610

Once actuation of measurement valve assembly 610 is complete, command processor 1802 may provide 1940 a "valve power off' message to supervisor processor 1800 Upon receiving 1942 the "valve power off' message, supervisor processor 1800 may deenergize 1944 relay / switch 1810 and provide 1946 a "valve power off message to command processor 1802

Upon receiving 1948 the "valve power off" message, command processor 1802 may provide 1950 a "valve close power request" message to supervisor processor 1800 Upon receiving 1952 the "valve close power request" message, supervisor processor 1800 may energize 1954 relay / switch 1810 (thus energizing shape memory actuator 652) and may send 1956 a "power on" message to command processor 1802 Upon receiving 1958 the "power on" message, command processor 1802 may actuate 1960 an energizing relay / switch (not shown) that is configured to energize shape memory actuator 652, during which time supervisor processor 1800 may monitor 1962 the actuation of e g , shape memory actuator 652

As discussed above (and referring temporarily to FIGS 26A, 26B, 27A, 27B & 28), shape memory actuator 652 may be anchored on a first end using electrical contact 654 The other end of shape memory actuator 652 may be connected to bracket assembly 656 When shape memory actuator 652 is activated, shape memory actuator 652 may pull bracket assembly 656 forward and release valve assembly 634 As such, 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 latch 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 de-activated state once bracket assembly 656 has released valve assembly 634 Accordingly, by actuating shape memory actuator 652, measurement valve assembly 610 may be deactivated Once actuation of shape memory actuator 652 is complete, command processor 1802 may provide 1964 a "power off' message to supervisor processor 1800 Upon receiving 1966 the "power off" message, supervisor processor 1800 may deenergize 1968 relay /switch 1810 and may provide 1970 a "power off message to command processor 1802 Upon receiving 1972 the "power off' message, command processor 1802 may determine the quantity of infusible fluid within volume sensor chamber 620, thus allowing command processor 1802 to compare this measured quantity to the quantity determined above (in step 1924) to determine 1974 the quantity of infusible fluid delivered to the user

In the event that the quantity of infusible fluid delivered 1974 to the user is less than the quantity of infusible fluid specified for the basal / bolus infusion event, the above-descπbed procedure may be repeated (via loop 1976)

Referring also to FIG 118, there is shown another illustrative example of the interaction amongst processors 1800, 1802, this time during the scheduling of a dose of infusible fluid Command processor 1802 may monitor 2000, 2002 for the receipt of a basal scheduling message or a bolus request message (respectively) Upon receipt 2000, 2002 of either of these messages, command processor 1802 may set 2004 the 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 veπfied 2010, supervisor processor 1800 may provide 2012 a "delivery accepted" message to command processor 1802 Upon receipt 2014 of the "delivery accepted" message, command processor 1802 may update 2016 the controller (e g , the controller discussed above and illustrated in FIG 110) and execute 2018 delivery of the basal / bolus dose of infusible fluid Command processor 1808 may monitor and update 2022 the total quantity of infusible fluid delivered to the user (as discussed above and illustrated in FIGS 117A-117B) Once the appropπate quantity of infusible fluid is delivered to the user, command processor 1802 may provide 2024 a "delivery done" message to supervisor processor 1800 Upon receipt 2026 of the "delivery done" message, supervisor processor 1800 may update 2028 the total quantity of infusible fluid delivered to the user In the event that the total quantity of infusible fluid delivered 2018 to the user is less than the quantity defined above (in step 2004), the infusion process discussed above may be repeated (via loop 2030) Referring also to FIG 119, there is shown an example of the manner in which supervisor processor 1800 and command processor 1802 may interact while effectuating a volume measurements via volume sensor assembly 148 (as described above)

Specifically, command processor 1802 may initialize 2050 volume sensor assembly 148 and begin collecting 2052 data from volume sensor assembly 148, the process of which may be repeated for each frequency utilized in the above-described sine sweep Each time that 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

Once data collection 2052 is completed for the entire sine sweep, command processor 1802 may estimate 2058 the volume of infusible fluid delivered by infusion pump assembly 100 Command processor 1802 may provide 2060 a volume estimate message to supervisor processor 1800 Upon receiving 2062 this volume estimate message, supervisor processor 1800 may check (i e , confirm) 2064 the volume estimate message Once checked (i e , confirmed), supervisor processor 1800 may provide 2066 a verification message to command processor 1802 Once received 2068 from supervisor processor 1800, command processor 1802 may set the measurement status for the dose of infusible fluid delivered by volume sensor assembly 148

As discussed above and referring temporarily to FIG 11), the various embodiments of the infusion pump assembly (e g , infusion pump assembly 100, 100', 400, 500) discussed above may be configured via a remote control assembly 300 When configurable via remote control assembly 300, the infusion pump assembly may include telemetry circuitry (not shown) that allows for communication (e g , wired or wireless) between the infusion pump assembly and e g , remote control assembly 300, thus allowing remote control assembly 300 to remotely control the infusion pump assembly Remote control assembly 300 (which may also include telemetry circuitry (not shown) and may be capable of communicating with the infusion pump assembly) may include display assembly 302 and input assembly 304 Input assembly 304 may include slider assembly 306 and switch assemblies 308, 310 In other embodiments, the input assembly may include a jog wheel, a plurality of switch assemblies, or the like Remote control assembly 300 may allow the user to program basal and bolus delivery events

Remote control assembly 300 may include two processors, 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 communication, e g , for communicating with infusion pump assembly 100, 100', 400, 500 The second processor included within remote control assembly (which may include but are not limited to an ARM920T and an ARM922T manufactured by ARM Holdings PLC of the United Kingdom) may be a command processor and may perform data processing tasks associated with e g , configuring infusion pump assembly 100, 100', 400, 500

Further and as discussed 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 communication, e g , for communicating with a remote control assembly 300 Two additional microprocessors (e g , supervisor processor 1800 and command processor 1802) may effectuate the delivery of the infusible fluid (as discussed above) Examples of supervisor processor 1800 and command processor 1802 may include, but is not limited to an MSP430 microcontroller, available from Texas Instruments Inc of Dallas, Texas

The OS may be a non-preemptive scheduling system, in that all tasks may run to completion before the next task is allowed to run regardless of priority Additionally, context switches may not be performed When a task completes executing, the highest priority task that is currently scheduled to run may then be executed If no tasks are scheduled to execute, the OS may place the processor (e g , supervisor processor 1800 and/or command processor 1802) into a low power sleep mode and may wake when the next task is scheduled The OS may only be used to manage main loop code and may leave lnterrupt-based functionality unaffected

The OS may be written to take advantage of the C++ language Inheritance as well as virtual functions may be key elements of the design, allowing for easy creation, scheduling and managing of tasks

At the base of the OS infrastructure may be the ability to keep track of system time and controlling the ability to place the processor in Low Power Mode (LPM, also known as sleep mode) This functionality along with the control and configuration of all system clocks ,ay be encapsulated by the SysClocks class

The SysClocks class may contain the functionality to place the processor (e g , supervisor processor 1800 and/or command processor 1802) into LPM to reduce energy consumption While m 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 Placing the processor into LPM may always be done by the provided SysClocks function This function may contain all required power down and power up sequences resulting in consistency whenever entering or exiting LPM Waking from LPM may be initiated by any interrupts based on the slow clock

The OS may keep track of three aspects of time seconds, milliseconds and the time of day Concerning seconds, SysClocks may count seconds starting when the processor comes out of reset The second counter may be based on the slow system clocks and, therefore, may increment regardless of whether the processor is in LPM or at full power As a result, it is the boundary at which the processor may wake from sleep to execute previously scheduled tasks If a task is scheduled to run immediately from an interrupt service routine (ISR), the ISR may wake the processor from LPM on exit and the task may be executed immediately Concerning milliseconds, in addition to counting the seconds since power on, SysClocks may also count milliseconds while the processor is in full power mode Since the fast clock is stopped during LPM, the millisecond counter may not increment Accordingly, whenever a task is scheduled to execute based on milliseconds, the processor may not enter LPM Concerning time of day, the time of day may be represented within SysClocks as seconds since a particular point time (e g , seconds since 01 January 2004)

The SysClocks class may provide useful functionality to be used throughout the Command and Supervisor project code base The code delays may be necessary to allow hardware to settle or actions to be completed SysClocks may provide two forms of delays, a delay based on seconds or a delay based on milliseconds When a delay is used, the processor may simply wait until the desired time has passed before continue with its current code path Only ISRs may be executed during this time SysClocks may provide all of the required functionality to set or retrieve the current time of day

The word "task" may be associated with more complex scheduling systems, therefore within the OS, task may be represented by and referred to as Managed Functions The ManagedFunc class may be an abstract base class that provides all the necessary control members and functionality to manage and schedule the desired functionality

The ManagedFunc base class may have five control members, two scheduling manipulation member functions, and one pure virtual execute function that may contain the managed functionality AU of the ManagedFunc control members may be hidden from the derived class and may only be directly set by the derived class during creation, thus simplifying the use and enhancing the safety of infusion pump assembly 100, 100', 400, 500

The Function ID may be set at the time of creation and may never be changed All Function IDs may be defined within a single h file, and the base ManagedFunc constructor may strongly enforce that the same ID may not be used for more than one managed function The ID may also define the priority of a function (with respect to other functions) based upon the function ID assigned, wherein higher priority functions are assigned lower function IDs The highest priority task that is currently scheduled to execute may execute before lower priority tasks

AU other control members may be used to represent the function's current scheduled state, when it should be executed, and if (upon execution) the function should be rescheduled to execute in a previously set amount of time Manipulation of these controls and states may be allowed but only through the public member functions (thus enforcing safety controls on all settings)

To control the scheduling of a managed function, the set start and set repeat functions may be used Each of these member functions may be a simple interface allowing the ability to configure or disable repeat settings as well as control whether a managed function is inactive, scheduled by seconds, milliseconds, or time of day

Through inheritance, creating a Managed Function may be done by creating a derived class and defining the pure virtual 'execute' function containing the code that needs to be under scheduling control The ManagedFunc base class constructor may be based upon the unique ID of a function, but may also be used to set default control values to be used at start up

For example to create a function that runs thirty seconds after start up and every 15 seconds thereafter, the desired code is placed into the virtual execute function and the function ID, scheduled by second state, thirty second start time, and repeat setting of fifteen seconds is provided to the constructor

The following is an illustrative code example concerning the creation of a managed 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 execute every ten seconds thereafter tinclude "ManagedFunc.h"

// The SendGoodFunc is a "heartbeat" status message class SendGoodFunc : public ManagedFunc

{ public:

// Initialize the managed func to run 2 seconds after start up

// and repeat every second.

SendGoodFunc ( ) :

ManagedFunc (IPC_SEND_GOOD, SCHEDULED_SEC, 1, true, 10) {};

~SendGoodFunc ( ) { } ; protected: void execute (void) ; }; void SendGoodFunc : : execute (void) {

// « code to send the heartbeat » }

SendGoodFunc g_sendGoodFunc;

// to manipulate the heartbeat timing simply call:

// g_sendGoodFunc.setFuncStart (...) or g_sendGoodFunc . setRepeat ( ... )

The actual execution of the Managed Functions may be controlled and performed by the SleepManager class. The SleepManager may contain the actual prioritized list of managed functions. This prioritized list of functions may automatically be populated by the managed function creation process and may ensure that each function is created properly and has a unique ID.

The main role of the SleepManager class may be to have its 'manage' function called repeatedly from the processors main loop and/or from a endless while loop. Upon each call of manage, the SleepManager may execute all functions that are scheduled to run until the SleepManager has exhausted all scheduled functions; at which time the SleepManager may place the processor in LPM. Once the processor wakes from LPM, the manage function may be reentered until the processor is again ready to enter LPM (this process may be repeated until stopped, e.g., by a user or by the system). If the processor has to be kept in full power mode for an extended period of time (e g , while an analog-to-digital conversion is being sampled), the SleepManager may provide functionality to disable entenng LPM While LPM is disabled, the manage function may continuously search for a scheduled task

The SleepManager may also provide an interface to manipulate the scheduling and repeat settings of any managed function through the use of the unique ID of the function, which may allow any section of code to perform any required scheduling without having direct access to or unnecessary knowledge of the desired ManagedFunc object

Radio circuitry included within each of infusion pump assembly 100, 100', 400, 500 and remote control assembly 300 may effectuate wireless communication between remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 A 2 4 GHz radio communications chip (e g , a Texas Instruments CC2510 radio transceiver) with an internal 8051 microcontroller may be used for radio communications

The radio link may balance the following three objectives link availability, latency, and energy

Concerning link availability, remote control assembly 300 may provide the primary means for controlling the 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 Concerning latency, the communications system may be designed to provide for low latency to deliver data from remote control assembly 300 to the infusion pump assembly 100, 100', 400, 500 (and vice versa) Concerning energy, both remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 may have a maximum energy expenditure for radio communications

The radio link may support half-duplex communications Remote control assembly 300 may be the master of the radio link, initiating all communications Infusion pump assembly 100, 100', 400, 500 may only respond to communications and may never initiate communications The use of such a radio communication system may provide vaπous benefits, such as increased security a simplified design (e g , for airplane use), and coordinated control of the radio link

Referring also to FIG 120A, there is shown one illustrative example of the various software layers of the radio communication system discussed above The radio processors included within remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 may transfer messaging packets between an SPI port and a 2 4 GHz radio link (and vice versa) The radio may always be the SPI slave On infusion pump assembly 100, 100', 400, 500, radio processor (PRP) 1818 (See FIGS 115-116) may service two additional nodes over the SPI port that are upstream (namely command processor 1800 and supervisor processor 1802 In some embodiments, on remote control assembly 300, the radio processor (CRP) may service at least one additional node over the SPI port that may be either upstream or down stream, for example, in some embodiments, the above-described remote control processor (UI) and the Continuous Glucose Engine (CGE)

A messaging system may allow for communication of messages between various nodes in the network The UI processor of remote control assembly 300 and e g , supervisor processor 1800 may use the messaging system to configure and initiate some of the mode switching on the two system radios It may be also used by the radios to convey radio and link status information to other nodes in the network

When the radio of remote control assembly 300 wishes to gather channel statistics from the infusion pump assembly 100, 100', 400, 500 or update the master channel list of the radio of infusion pump assembly 100, 100', 400, 500, the radio of remote control assembly 300 may use system messages Synchronization for putting the new updated list into effect may use flags in the heartbeat messages to remove timing uncertainty

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

The radio seπal 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 that may only include the radio seπal number of remote control assembly 300, thus ensuring that only occur with the remote control assembly / infusion pump assembly to which it is paired The CC2510 may support a one byte logical node address and it may be advantageous to use one byte of the radio seπal number as the logical node address to provide a level of filtering for incoming packets

The Quiet_Radio signal may be used by the UI processor of remote control assembly 300 to prevent noise interference on the board of remote control assembly 300 by 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 asserting Radio Quiet Mode for a pre-determined peπod of time The Quiet Radio feature may not be required based on noise interference levels measured on the PC board of remote control assembly 300 During this period of time, the radio of remote control assembly 300 may stay in Sleep Mode 2 for up to a maximum of 100 ms The radio of remote control assembly 300 may come out of Sleep Mode 2 when the Quiet_Radio signal is de-asserted or the maximum time period has expired The UI processor of remote control assembly 300 may assert Quiet_Raόjo at least one radio communication's interval before the event needs to be asserted The radio of remote control assembly 300 may inform the radio of infusion pump assembly 100, 100', 400, 500 that communications will be shutdown during this quiet peπod The periodic radio link protocol may have status bits / bytes that accommodate the Quiet_Radio feature unless Quiet_Radio is not required

The radio software may integrate with the messaging system and radio bootloader on the same processor, and may be verified using a throughput test The radio software may integrate with the messaging system, SPI Dπver using DMA, and radio bootloader, all on the same processor (e g , the TI CC2510)

The radio of remote control assembly 300 may be configured to consume no more than 32 mAh in three days (assuming one hundred minutes of fast 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 in three days (assuming one hundred minutes of fast heartbeat mode communications per day)

The maximum time to reacquire communications may be < 6 1 seconds including connection request mode and acquisition mode The radio of remote control assembly 300 may use the fast heartbeat mode or slow heartbeat mode setting to its advantage in order to conserve power and minimize latency to the user The difference between the infusion pump assembly 100, 100', 400, 500 and remote control assembly 300 entenng acquisition mode may be that the infusion pump assembly 100, 100', 400, 500 needs to enter acquisition mode often enough to ensure communications may be restored within the maximum latency period However, the remote control assembly 300 may change how often to enter acquisition mode with the infusion pump assembly 100, 100', 400, 500 when in slow heartbeat mode and heartbeats are lost The radio of remote control assembly 300 may have knowledge of the user GUI interaction, but the infusion pump assembly 100, 100', 400, 500 may not

The radio of remote control assembly 300 may set the heartbeat peπod for both radios The period may be selectable in order to optimize power and link latency depending on activity The desired heartbeat period may be communicated in each heartbeat from the radio of remote control assembly 300 to the radio of infusion pump assembly 100, 100', 400, 500 This may not exclusively establish the heartbeat rate of infusion pump assembly 100, 100', 400, 500 due to other conditions that determine what mode to be in When in fast heartbeat mode, the radio of remote control assembly 300 may set the heartbeat peπod to 20 ms if data packets are available to send or receive, thus providing low link latency communications when data is actively being exchanged

When in fast heartbeat mode, the radio of remote control assembly 300 may set the heartbeat peπod to 60 ms four heartbeats after a data packet was last exchanged in either direction on the radio Keeping the radio heartbeat peπod short after a data packet has been sent or received may assure that any data response packet may be also serviced using a low link latency When in slow heartbeat mode, the heartbeat rate may be 2 00 seconds or 6 00 second, depending upon online or offline status respectively

The infusion pump assembly 100, 100', 400, 500 may use the heartbeat rate set by the radio of remote control assembly 300 The radio of remote control assembly 300 may support the following mode requests via the messaging system

• Paiπng Mode

• Connection Mode

• Acquisition Mode (includes the desired paired infusion pump assembly 100, 100', 400, 500 radio serial number)

• Sync Mode - Fast Heartbeat

• Sync Mode - Slow Heartbeat • RF Off Mode

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

• Pairing Mode

• Acquisition Mode

• RF Off Mode

The radio may use a system message to obtain the local radio serial number. On remote control assembly 300, the radio may get the serial number from the UI processor of remote control assembly 300. The radio may use a system message to store the paired radio serial number.

Remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 may issue a status message using the messaging system to the UI processor of remote control assembly 300 and command processor 1802 whenever the following status changes:

• Online Fast: Successful connection

• Online Fast: Change from Acquisition Mode to Fast Heartbeat Mode

• Online Slow: Successful request change from Fast Heartbeat to Slow Heartbeat

• Offline: Automatic change to Search Sync mode due to lack of heartbeat exchanges.

• Online Fast: Successful request change from Slow Heartbeat to Fast Heartbeat

• Offline: Bandwidth falls below 10% in Sync Mode

• Online: Bandwidth rises above 10% in Search Sync mode

• Offline: Successful request change to RF Off Mode

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

There may be two parameters in the radio configuration message: namely the number of RF retries (e.g., the value may be from 0 to 10); and the radio offline parameters (e.g., the value may be from 1 to 100 in percent of bandwidth). The radio application on both the 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

The following parameters may be recommended for the radio hardware configuration

• Base Radio Specifications

• MSK

• 250 kbps over air baud rate

• Up to 84 channels

• Channel spacing 1000 kHz

• Filter bandwidth 812 kHz

• No Manchester encoding

• Data whitening

• 4 byte preamble

• 4 byte sync (word)

• CRC appended to packet

• LQI (Link Quality Indicator) appended to packet

• Automatic CRC filtering enabled

Forward Error Correction (FEC) may or may not be utilized Although Forward Error Correction (FEC) may be used to increase the effective signal dynamic range by approximately 3 dB, FEC requires fixed packet sizes and doubles the number of over the air bits for the same fixed size message

The radio may function within 1 83 meters distance under nominal operating conditions (except in pairing mode) It may be a goal that the radio function within 7 32 meters distance under nominal operating conditions The transmit power level may be 0 dBm (except in pairing mode) and the transmit power level in paiπng mode may be -22 dBm Since the desired radio node address of infusion pump assembly 100, 100', 400, 500 may be not known by the remote control assembly 300 in paiπng mode, both infusion pump assembly 100, 100', 400, 500 and remote control assembly 300 may use a lower transmit power to reduce the likelihood of inadvertently pairing with another infusion pump assembly AES Encryption may be used for all packets but may not be required, as the Texas Instruments CC2510 radio transceiver includes this functionality IfAES encryption is used, fixed keys may be utilized, as fixed keys provide a quick way to enable encryption without passing keys However, key exchange may be provided for in future versions of infusion pump assembly 100, 100', 400, 500 The fixed keys may be contained in one separate header source file with no other variables but the fixed keys data, thus allowing for easier management of read access of the file

The radio software may support the following eight modes

• Pairing Mode

• RF Off Mode

• Connection Mode

• Acquisition Mode

• Fast Heartbeat Mode

• Slow Heartbeat Mode

• Search Sync Mode

• Sync'ed Acquisition Mode which are graphically depicted in FIGS 120B- 12OC

Paiπng may be the process of exchanging radio seπal numbers between remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 Remote control assembly 300 may be "paired" with infusion pump assembly 100, 100', 400, 500 when infusion pump assembly 100, 100', 400, 500 knows its seπal number Infusion pump assembly 100, 100', 400, 500 may be "paired" with remote control assembly 300 when remote control assembly 300 knows its serial number

Pairing mode (which is graphically depicted in FIG 120D) may require that four messages to be exchanged over the RF link

• RF Paiπng Request (broadcast from Remote control assembly 300 to any Infusion pump assembly 100, 100', 400, 500)

• RF Paiπng Acknowledge (from Infusion pump assembly 100, 100', 400, 500 to Remote control assembly 300) • RF Pairing Confirm Request (from Remote control assembly 300 to Infusion pump assembly 100, 100', 400, 500)

• RF Pairing Confirm Acknowledge (from Infusion pump assembly 100, 100', 400, 500 to Remote control assembly 300)

Additionally, remote control assembly 300 may cancel the pairing process at any time via the 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 transfers

The radio of infusion pump assembly 100, 100', 400, 500 may enter paiπng mode upon receiving a paiπng mode request message It may be the responsibility of supervisor processor 1800 on infusion pump assembly 100, 100', 400, 500 to request the radio to enter paiπng mode if there is no disposable 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 six seconds The radio of infusion pump assembly 100, 100', 400, 500 may set the appropriate transmit power level for pairing mode Infusion pump assembly 100, 100', 400, 500 may only be paired with one remote control assembly 300 at a time

Upon receiving the first valid RF pairing request message while in paiπng mode, the radio of infusion pump assembly 100, 100', 400, 500 may use the seπal number of remote control assembly 300 for the duration of paiπng mode and respond with an RF pairing acknowledge message containing the radio serial number infusion pump assembly 100, 100', 400, 500

The radio of infusion pump assembly 100, 100', 400, 500 may timeout of paiπng mode automatically after 20 ± 02 seconds if no RF paiπng request is received The radio of infusion pump assembly 100, 100', 400, 500 may issue a paiπng request received message after transmitting the RF paiπng acknowledge This message to supervisor processors will allow feedback to the user during the paiπng confirm process The radio of infusion pump assembly 100, 100', 400, 500 may automatically timeout of paiπng mode in 1 0 ± 0 1 minutes after sending an RF paiπng acknowledge unless an RF painng confirm request is received The radio of infusion pump assembly 100, 100', 400, 500 may issue a store paired radio seπal number message if an RF painng confirm request message is received after receiving a RF pairing request 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 the infusion pump assembly 100, 100', 400, 500

The radio of infusion pump assembly 100, 100', 400, 500 may transmit an RF pairing confirm acknowledge and exit paiπng mode after the acknowledgment from the store paired radio serial number message is received This may be the normal exit of paiπng mode on infusion pump assembly 100, 100', 400, 500 and may result in infusion pump assembly 100, 100', 400, 500 powering down until connection mode or paring mode entered by the user

If the radio of infusion pump assembly 100, 100', 400, 500 exits pairing mode upon successfully receiving a paiπng confirm request message, then the radio of infusion pump assembly 100, 100', 400, 500 may revert to the newly paired remote control assembly 300 and may send a paiπng completion success message to command processor 1802 The radio of infusion pump assembly 100, 100', 400, 500 may exit pairing mode upon receiving an RF pairing abort message The radio of infusion pump assembly 100, 100', 400, 500 may exit paiπng mode upon receiving a painng abort request message addressed to it This may allow command processor 1802 or supervisor processor 1800 to abort the paiπng process locally on the infusion pump assembly 100, 100', 400, 500

The radio of remote control assembly 300 may enter pairing mode upon receiving a pairing mode request message It may be the responsibility of the UI processor of remote control assembly 300 to request that the radio enter painng mode under the appropπate conditions The radio of remote control assembly 300 may set the appropnate transmit power level for paiπng mode The radio of remote control assembly 300 may transmit RF paiπng requests until an RF pairing acknowledge is received or paiπng is aborted

The radio of remote control assembly 300 may automatically abort paiπng mode if the RF paiπng acknowledge message is not received within 300 ± 1 0 seconds after entering pairing mode Upon receiving the first valid RF pairing acknowledge message while in pairing mode, the radio of remote control assembly 300 may send a painng success message to the UI processor of remote control assembly 300 that includes the seπal number of infusion pump assembly 100, 100', 400, 500 and may use that seπal number for the duration of paiπng mode This message may provide a means for the UI processor of remote control assembly 300 to have the user 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 (concerning a single pairing request) from infusion pump assembly 100, 100', 400, 500, the first valid one may be used

The Radio of remote control assembly 300 may only accept an RF pairing confirm acknowledge messages after an RF pairing acknowledge is received while in pairing mode The radio of remote control assembly 300 may transmit the RF painng confirm message upon receiving a pair confirm request message from the UI processor of remote control assembly 300

The radio of remote control assembly 300 may check that infusion pump assembly 100, 100', 400, 500 confirms the pairing before adding infusion pump assembly 100, 100', 400, 500 to the pairing list The radio of remote control assembly 300 may issue a store paired radio serial number message if an RF pairing complete message is received 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 of a successful pairing It may be the responsibility of the UI processor of remote control assembly 300 to manage the list of paired infusion pump assemblies

The radio of remote control assembly 300 may send an RF pairing abort message and exit pairing mode upon receiving a pairing abort request message This may allow the UI processor of the remote control assembly 300 to abort the pairing process on both the remote control assembly 300 and acknowledged infusion pump assembly 100, 100', 400, 500

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 paired infusion pump assembly list and retrieve its "connection ready" status The "connection" process (which is graphically depicted in FIG 120E) may allow remote control assembly 300 to quickly identify one of its paired infusion pump assemblies that may be ready to be used The radio of remote control assembly 300 may be capable of performing the connection request mode with up to six paired infusion pump assemblies Connection request mode may be only supported on remote control assembly 300 and may be a special form of acquisition mode In connection request mode, remote control assembly 300 may connect with the first infusion pump assembly to respond However, each message may be directed to a specific infusion pump assembly serial number

The radio of remote control assembly 300 may obtain the latest paired infusion pump assembly serial number list upon entering connection mode The radio of remote control assembly 300 may enter connection mode upon receiving a connection mode request message It may be the responsibility of the UI processor of remote control assembly 300 to request that the radio enter connection mode when it desires communications with a paired infusion pump assembly The radio of remote control assembly 300 may issue a connection assessment message to the UI processor of remote control assembly 300 containing the radio serial number of the first infusion pump assembly, if any, that is "connection ready" The radio of remote control assembly 300 may generate the connection assessment message within thirty seconds of entering connection request mode The radio of remote control assembly 300 may exit connection request mode upon receipt of the connection assessment acknowledgement and transition to fast heartbeat mode The radio of remote control assembly 300 may exit connection request mode upon receipt of a connection request abort message from the UI processor of remote control assembly 300

On remote control assembly 300, acquisition mode may be used to find a particular paired infusion pump assembly The radio of remote control assembly 300 may send RF RUT (aRe yoU There) packets 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 opportunity for the radio of remote control assembly 300 to find the paired infusion pump assembly

The radio of remote control assembly 300 may enter acquisition mode upon receiving an acquisition mode request or fast heartbeat mode request message while in RF Off Mode The radio of remote control assembly 300 may enter sync'ed acquisition mode upon receiving an acquisition mode request or fast heartbeat mode request message while in search sync mode It may be the responsibility of the UI processor of remote control assembly 300 to request that the radio enter acquisition mode when the RF link is off-line and remote control assembly 300 desires communications with infusion pump assembly 100, 100', 400, 500

The radio of remote control assembly 300 may only communicate with one paired infusion pump assembly 100, 100', 400, 500 (except in paiπng and connection modes) When communications are 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 communications

Infusion pump assembly 100, 100', 400, 500 may enter acquisition mode under the following conditions • When in Radio Off Mode and Acquisition Mode may be requested

• When Search Sync Mode times out due to lack of heartbeats

Upon entering acquisition mode, the radio of infusion pump assembly 100, 100', 400, 500 may obtain the serial number of the last stored paired remote control assembly 300 The radio of infusion pump assembly 100, 100', 400, 500 may only communicate with the remote control assembly to which it has been "paired" (except while in the "pairing request" mode) The radio of infusion pump assembly 100, 100', 400, 500 may transition from acquisition mode to fast heartbeat mode upon successfully acquiring synchronization with the remote control assembly 300 The acquisition mode of infusion pump assembly 100, 100', 400, 500 may be capable of acquiring synchronization within 6 1 seconds, which may implies that the infusion pump assembly 100, 100', 400, 500 may always be listening at least every ~6 seconds when in acquisition mode

Data packets may be sent between two paired devices when the two devices are in sync mode and online The two devices may sync via a heartbeat packet before data packets are exchanged Each radio may send data packets at known time intervals after the heartbeat exchange The infusion pump assembly 100, 100', 400, 500 may adjust its timing to anticipate reception of a packet The radio may support one data packet in each direction on each heartbeat The radio may provide a negative response to a fast heartbeat mode request if the radio if offline The radio of remote control assembly 300 may change to fast heartbeat mode if a system request for fast heartbeat mode is received while in slow heartbeat mode and the radio is online

Upon transitioning to fast heartbeat mode from acquisition mode, the radio of remote control assembly 300 may send the master channel list message The master channel list may be built by the radio of remote control assembly 300 and sent to the radio of infusion pump assembly 100, 100', 400, 500 to allow a selection of frequency hopping channels based on historical performance When in fast heartbeat mode 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 periodicity of these messages may be at the heartbeat rate The heartbeat messages may allow data packet transfers to take place and may also exchange status information The two radios may exchange the following status information Quiet Mode, data availability, buffer availability, heartbeat rate, and prior channel performance It may be a goal to keep the packet size of the heartbeat messages small in order to conserve power The radio may provide for a maximum data packet size of eighty-two bytes when in Sync Mode The messaging system may be designed to support packet payload sizes up to sixty-four bytes This maximum size was selected as an optimal trade-off between minimum messages types and non-fragmented messages The eighty-two bytes may be the maximum packet size of the messaging system including packet overhead

The messaging system has an API that may allow the radio protocol to send an incoming radio packet to it. The messaging system may also have an API that allows the radio protocol to get a packet for transmission over the radio network The messaging system may be responsible for packet routing between the radio protocol and the SPI port Data packets may be given 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 over the radio network The radio protocol may query the messaging system on each heartbeat to determine if data packets are available to send over the radio network It may be desirable for the software to check the availability of a message just before the heartbeat is sent to minimize round trip message latency

The radio protocol may be capable of buffering one incoming radio data packet and passing the packet to the messaging system The radio protocol may send the data packet to the messaging system upon receipt of the data packet The message system may be responsible for routing radio data packets to the proper destination node The radio protocol may be capable of buffering one packet from the messaging system

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 the source and destination radio serial numbers, RF ACK command identification, and sequence number of the data packet being acknowledged

The radio transmitting a radio data packet may retransmit that radio data packet on the next heartbeat with the same sequence number if an RF ACK is not received and the retry count is within the maximum RF retries allowed It may be expected that, from time to time, interference will corrupt a transmission on a particular frequency An RF retry allows the same packet to be retransmitted at the next opportunity at a different frequency The sequence number provides a means of uniquely identifying the packet over a short time window The number of radio packet retries may be configurable using the radio configuration command Allowing more retries may increase the probability of a packet being exchanged but introduces more latency for a round trip messages The default number of radio retries at power up may be ten (i e , the maximum transmission attempts before dropping the message)

A one byte (modulo 256) radio sequence number may be included in all radio data packets over the RF link Since the radio may be responsible for retrying data packet transmission if not acknowledged, the sequence number may provide a way for the two radios to know if a data packet is a duplicate The transmitted sequence number may be incremented for each new radio data packet and may be allowed to rollover When a data packet is successfully received with the same sequence number as the previous successfully received data packet (and in the same direction), the data packet may be ACK'd and the received data packet discarded This may remove duplicate packets generated by the RF protocol before they are introduced into the network Note that it may be possible that multiple data packets in a row may need to be dropped with the same sequence number under extreme situations

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 send and listen respectively for subsequent heartbeats 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 sync mode if heartbeats are missed for two seconds This may minimize power consumption when the link is lost by allowing the radios to continue to use their synchronization information, as two seconds allows sufficient time to hop through all channels

The radio may be considered online while in the following modes

• Fast Heartbeat mode

• Slow Heartbeat mode as these are the only conditions where messaging system traffic may be exchanged All other conditions may be considered offline

The radio may initialize to radio off mode at the start of code execution from reset When code first executes on the radio processor, the initial state may be the radio off mode to allow other processors to perform self-tests before requesting the radio to be active This requirement does not intend to define the mode when waking from sleep mode The radio may cease RF communications when set to radio off mode On remote control assembly 300, this mode may be intended for use on an airplane to suppress RF emissions Since infusion pump assembly 100, 100', 400, 500 only responds to transmissions from remote control assembly 300 (which will have ceased transmitting in airplane mode), radio off mode may only be used on infusion pump assembly 100, 100', 400, 500 when charging

Command processor 1802 may be informed of airplane mode and that, therefore, the RF was intentionally turned off on remote control assembly 300 so that it does not generate walkaway alerts However, this may be completely hidden from the radio of infusion pump assembly 100, 100', 400, 500

The radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 may periodically attempt to exchange heartbeats in order to reestablish data bandwitdh while in search sync mode The radio of remote control assembly 300 may transition to radio off mode after twenty minutes of search sync mode with no heartbeats successfully exchanged

The radio of infusion pump assembly 100, 100', 400, 500 may transition to acquisition mode after twenty minutes of search sync mode with no heartbeats successfully exchanged Listening during pre-agreed time slots may be the most efficient use of power for infusion pump assembly 100, 100', 400, 500 to re-establish the RF link After a loss of communications, the crystal tolerance and temperature drift may make it necessary to expand the receive window of infusion pump assembly 100, 100', 400, 500 over time Staying in search sync mode for extended periods (e g , 5-20 minutes) after communications loss may cause the instantaneous power consumed to exceed 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 expand its window, so staying 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

The radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 may transition to slow heartbeat mode if they successfully exchange three of the last five heartbeats Approximately every six seconds, a burst of five heartbeats may be attempted If three of these are successful, the bandwidth may be assumed to be sufficient to transition to slow heartbeat mode The radio of infusion pump assembly 100, 100', 400, 500 may be acquirable while in search sync mode with a latency of 6 1 seconds This may imply that the infusion pump assembly 100, 100', 400, 500 may always be listening at least every ~6 seconds when in search sync mode

Radio protocol performance statistics may be necessary to promote troubleshooting of the radio and to assess radio performance The following radio performance statistics may be maintained by the radio protocol in a data structure

A #define DEBUG option (compiler option) may be used to gather the following additional radio performance statistics per each channel (16 bit numbers)

• Number of missed hops

• CCA good count

• CCA bad count

• Average RSSI (accumulated for good RX packets only)

• Dropped from Frequency Hop List count

• Acquisition Mode count (found pair on this channel)

The debug option may be used to gather engineering only statistics If processor performance, power, and memory allow, it may be desirable to keep this information at runtime The radio statistics may be made available to the messaging system

Link quality may be intended to be used on remote control assembly 300 to provide a bar indicator, similar to a cell phone, of the radio link quality Link quality may be made available to both remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 It may be anticipated that the link quality status will consist of a one byte indicator of the quality of the radio link

The radio may change frequency for each heartbeat An adaptive pseudo random frequency hopping algorithm may be used for sync mode and heartbeat attempts in search sync mode It may be a goal to use sixty-four channels for frequency hopping An algorithm may be developed to adaptively generate a channel list on remote control assembly 300 for frequency hopping The radio of remote control assembly 300 may build, maintain, and distribute the master channel list Prior channel statistics and historical performance information may be obtained from the radio of infusion pump assembly 100, 100', 400, 500 by the radio of remote control assembly 300 using the 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 may be considered The radios may adaptively select hopping channels to meet the round trip message latency, while operating in a desirable RF environment

Occlusions and/or leaks may occur anywhere along the fluid delivery path of infusion pump assembly 100 For example and referring to FIG 121, occlusions / leaks may occur in the fluid path between reservoir 118 and reservoir valve assembly 614, m 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 occlusion / leak detection algorithms that detect and locate such occlusions / leaks and enhance the safety / reliability of infusion pump assembly 100

As discussed above, when administering the infusible fluid, infusion pump assembly 100 may first determine the volume of infusible fluid within volume sensor chamber 620 prior to the administration of the dose of infusible fluid and may subsequently determine the volume of infusible fluid within volume sensor chamber 620 after the administration of the dose of infusible fluid By monitoring these values, the occurrence of occlusions / leaks may be detected

Occlusion Type - Total: When a total occlusion is occurring, the difference between the initial measurement prior to the administration of the dose of infusible fluid and the final measurement after the administration of the dose of infusible fluid will be zero (or essentially zero), indicating a large residual quantity of infusible fluid within volume sensor chamber 620 Accordingly, no fluid may be leaving volume sensor chamber 620

Specifically, if the tip of disposable cannula is occluded, the fluid path down stream of volume sensor chamber 620 will fill with fluid and eventually become pressurized to a level equivalent to the mechanical pressure exerted by spring diaphragm 628 Accordingly, upon measurement valve assembly 610 opening, zero (or essentially zero) fluid will be dispensed and, therefore, the value of the initial and final measurements (as made by volume sensor assembly 148 ) will essentially be equal

Upon detecting the occurrence of such a condition, a total occlusion flag may be set and infusion pump assembly 100 may e g , trigger an alarm, thus indicating that the user needs to seek alternative means for receiving their therapy

Occlusion Type - Partial: When a partial occlusion is occurring, the difference between the initial measurement pπor to the administration of the dose of infusible fluid and the final measurement after the administration of the dose of infusible fluid will indicate that less than a complete dose of infusible fluid was delivered For example, assume that at the end of a particular pumping cycle, volume sensor assembly 148 indicated that 0 10 microliters of infusible fluid were present in volume sensor chamber 620 Further, assume that measurement value assembly 610 is subsequently closed and pump assembly 106 is subsequently actuated, resulting in volume sensor chamber 620 being filed with the infusible fluid Further assume that volume sensor assembly 148 determines that volume sensor chamber 620 is now filled with 1 00 microliters of infiisible fluid (indicating a pumped volume of 0 90 microliters)

Accordingly, upon the opening of measurement valve assembly 610, the quantity of infusible fluid included within volume sensor chamber would be expected to drop to 0 10 microliters (or reasonably close thereto) However, in the event of a partial occlusion, due to a slower-than-normal flow rate from volume sensor chamber 620, the quantity of infusible fluid within volume sensor chamber 620 may only be reduced to 040 microliters (indicating a delivered volume of 060 microliters) Accordingly, by monitoring the difference between the pumped volume (090 microliters) and the delivered volume (060 microliters), the residual volume may be defined and the occurrence of a partial occlusion may be detected

Upon detecting the occurrence of such a condition, a partial occlusion flag may be set and infusion pump assembly 100 may e g , trigger an alarm, thus indicating that the user needs to seek alternative means for receiving their therapy However, as this is indicative of a partial occlusion (as opposed to a complete occlusion), the issuance of an alarm may be delayed, as the partial occlusion may clear itself

Alternatively, infusion pump assembly 100 may calculate a pump ontime to volume delivered ratio, track it through time, and track by using a fast moving and a slow moving exponential average of the pump ontime The exponential average may be tracked, in a fashion similar to the leaky sura integrator The infusion pump assembly 100 may filter signal and look for a fast change The rate of fluid outflow and/or residual volume may be monitored If the residual volume does not change, then there may be a total occlusion If the residual volume changed, they may be a partial occlusion Alternatively still, the residual values may be summed If the number of valve actuations or the latch time is being varied, the fluid flow rate may be examined, even if you build up pressure in volume sensor assembly 148

Total/ Partial Empty Reservoir: When reservoir 118 is becoming empty, it will become more difficult to fill volume sensor chamber 620 to the desired level Typically, pump assembly 106 is capable of pumping 1 0 microliters per millisecond For example, assume that an "empty" condition for volume sensor chamber 620 is 0 10 microliters and a "full" condition for volume sensor chamber 620 is 1 00 microliters However, as reservoir 118 begins to empty, it may become harder for pump assembly 106 to fill volume sensor chamber 620 to the "full" condition and may consistently miss the goal Accordingly, duπng normal operations, it may take one second for pump assembly 106 to fill volume sensor chamber 620 to toe "full" condition and, as reservoir 118 empties, it may take three seconds to fill volume sensor chamber 620 to the "full" condition Eventually, if reservoir 118 completely empties, volume sensor chamber 620 may never be able to achieve a "full condition" Accordingly, the inability of pump assembly 106 to fill volume sensor chamber 620 to a "full" condition may be indicative of reservoir 118 being empty Alternatively, the occurrence of such a condition may be indicative of other situations (e g , the failure of pump assembly 106 or an occlusion in the fluid path prior to volume sensor chamber 620) Infusion pump assembly 100 may determine the difference between the "full" condition and the amount actually pumped These differences may be summed and the made up for once the reservoir condition is addressed

Upon detecting the occurrence of such a condition, an empty flag may be set and infusion pump assembly 100 may e g , trigger an alarm, thus indicating that the user needs to e g , replace disposable housing assembly 114

Additionally, as reservoir 118 empties, reservoir 118 will eventually result in a "vacuum" condition and the ability of pump assembly 106 to deliver fluid to volume sensor chamber 620 may be compromised As discussed above, volume controller 1602 may include feed forward controller 1652 for setting an initial "guess" concerning "on-time" signal 1606, wherein this initial guess is based upon a pump calibration curve For example, in order for pump assembly 106 to deliver 0010 units of infusible fluid, feed forward controller 1652 may define an initial "on-time" of e g , one millisecond However, as reservoir 118 begins to empty, due to compromised pumping conditions, it may take two milliseconds to deliver 0010 units of infusible fluid Further, as reservoir 118 approaches a fully empty condition, it make take ten milliseconds to deliver 0010 units of infusible fluid Accordingly, the occurrence of reservoir 118 approaching an empty condition may be detected by monitoring the level at which the actual operation of pump assembly 106 (e g , two milliseconds to deliver 0010 units of infusible fluid) differs from the anticipated operation of pump assembly 106 (e g , one millisecond to deliver 0010 units of infusible fluid)

Upon detecting the occurrence of such a condition, a reserve flag may be set and infusion pump assembly 100 may e g , trigger an alarm, thus indicating that the user will need to e g , replace disposable housing assembly 114 shortly

Leak Detection: In the event of a leak (e g , a leaky valve or a rupture / perforation) within the fluid path, the ability of the fluid path to retain fluid pressure may be compromised Accordingly, in order to check for leaks within the fluid path, a bleed down test may be performed m which pump assembly 106 is used to pressurize volume sensor chamber 620 Volume sensor assembly 148 may then perform a first volume measurement (as described above) to determine the volume of infusible fluid within volume sensor chamber 620 Infusion pump assembly 100 may then wait a defined period of time to allow for bleed down in the event of a leak For example, after a sixty second bleed down penod, volume sensor assembly 148 may perform a second volume measurement (as described above) to determine the volume of infusible fluid within volume sensor chamber 620 If there are no leaks, the two volume measurements should be essentially the same However, in the event of a leak, the second measurement may be less then the first measurement Additionally, depending on the seventy of the leak, pump assembly 106 may be incapable of filling volume sensor chamber 620 Typically, a leak check may be performed as part of a delivery of infusible fluid

In the event that the difference between the first volume measurement and the second volume measurement exceeds an acceptable threshold, a leak flag may be set and infusion pump assembly 100 may e g , trigger an alarm, thus indicating that the user needs to seek alternative means for receiving their therapy As discussed above, infusion pump assembly 100 may include supervisor processor 1800, command processor 1802, and radio processor 1818 Unfortunately, once assembled, access to electrical control assembly 110 within infusion pump assembly 100 very limited Accordingly, the only means to access electrical control assembly 110 (e g , for upgrading flash memories) may be through the communication channel established between infusion pump assembly 100, 100', 400, 500 and remote control assembly 300, or via electrical contacts 834 used by battery charger 1200

Electrical contacts 834 may be directly coupled to radio processor 1818 and may be configured to provide I2C communication capability for erasing / programming any flash memory (not shown) included within radio processor 1818 The process of loading a program into radio processor 1818 may provide a means for erasing / programming of the flash memoπes in both the supervisor processor 1800 and command processor 1802

When programming supervisor processor 1800 or command processor 1802, the program (i e , data) to be loaded into flash memory accessible by supervisor processor 1800 or command processor 1802 may be provided in a plurality of data blocks This is because the radio processor 1818 may not have enough memory to hold the entire flash image of the software as one block

Referring also to FIG 122, there is shown one illustrative example of the manner in which the various systems within infusion pump assembly 100, 100', 400, 500 may be interconnected For example, battery charger 1200 may be coupled to computing device 2100 (e g , a personal computer) via bus translator 2102, which converts e g , RS232 formatted data to e g , I2C formatted data Bus translator 2102 may execute a pass-through program that effectuates the above-described translation Battery charger 1200 may be coupled to radio processor 181 via electrical contacts 834 (described above) Radio processor 1818 may then be coupled to supervisor processor 1800 and command processor 1802 via e g , an RS232 bus Radio processor 1818 may execute an update program that allows radio processor 1818 to control / orchestrate the updating of the flash memoπes accessible by supervisor processor 1800 and command processor 1802 Accordingly, through the use of the above-described coupling, software updates obtained by computing device 2100 may be uploaded to flash memory (not shown) accessible by supervisor processor 1800 and command processor 1802 The above- described software updates may be command line program that may be automatically invoked by a script process As discussed above, infusion pump assembly 100, 100' 400, 500 may be configured to deliver an infusible fluid to a user Further and as discussed above, infusion pump assembly 100, 100' 400, 500 may deliver the infusible fluid via sequential, multi-part, infusion events (that may include a plurality of discrete infusion events) and/or one-time infusion events However, in some embodiments, infusion pump assembly 100, 100' 400, 500 may deliver stacking bolus infusion events For example, a user may request the delivery of a bolus, e g , 6 units While the 6 units are in the process of being delivered to the user, the user may request a second bolus, e g , 3 units In some embodiments of infusion pump assembly 100, 100' 400, 500 may deliver the second bolus at the completion of the first bolus

Examples of other such sequential, multi-part, infusion events may include but are not limited to a basal infusion event and an extended-bolus infusion event As is known in the art, a basal infusion event refers to the repeated injection of small (e g 005 unit) quantities of infusible fluid at a predefined interval (e g every three minutes) that may be repeated until stopped, e g , by a user or by the system Further, the basal infusion rates may be preprogrammed and may include specified rates for pre-programmed time-frames, e g , a rate of 050 units per hour from 600 am - 3 00 pm, a rate of 040 units per hour from 3 00 pm - 10 00 pm, and a rate of 035 units per hour from 10 00 pm - 6 00 am However, the basal rate may be 0025 units per hour, and may not change according to pre-programmed time-frames The basal rates may be repeated regularly / daily until otherwise changed

Further and as is known in the art, an extended-bolus infusion event may refer to the repeated injection of small (e g 0 05 unit) quantities of infusible fluid at a predefined interval (e g every three minutes) that is repeated for a defined number of intervals (e g , three intervals) or for a defined period of time (e g , nine minutes) An extended-bolus infusion event may occur simultaneously with a basal infusion event

If multiple infusion events conflict with each other, infusion pump assembly 100, 100' 400, 500 may prioritize the infusion event in the follow manner

Referring also to FIG 123, assume for illustrative purposes only that the user configures infusion pump assembly 100, 100' 400, 500 to administer a basal dose (e g 005 units) of infusible fluid every three minutes The user may utilize remote control assembly 300 to define a basal infusion event for the infusible fluid (e g , 1 00 units per hour) Infusion pump assembly 100, 100' 400, 500 may then determine an infusion schedule based upon the basal infusion event defined Once determined, infusion pump assembly 100, 100' 400, 500 may administer the sequential, multi-part, infusion event (e g , 005 units of infusible fluid every three minutes) Accordingly, while administering the sequential, multi-part, infusion event, infusion pump assembly 100, 100' 400, 500 may infuse a first 0 05 unit dose 2200 of the infusible fluid at t=0 00 (i e , a first discrete infusion event), may infuse a second 005 unit dose 2202 of the infusible fluid at t=3 00 (i e , a second discrete infusion event), may infuse a third 005 unit dose 2204 of the infusible fluid at t=600 (i e , a third discrete infusion event), may infuse a fourth 005 unit dose 2206 of the infusible fluid at t=9 00 (i e , a fourth discrete infusion event), and may infuse a fifth 005 unit dose 2208 of the infusible fluid at t=12 00 (i e , a fifth discrete infusion event) As discussed above, this pattern of infusing 005 unit doses of the infusible fluid every three minutes may be repeated until stopped, e g , by a user or by the system, in this example, as this is an illustrative example of a basal infusion event

Further, assume for illustrative purposes that the infusible fluid is insulin and sometime after the first 005 unit dose 2200 of infusible fluid is administered (but before the second 005 unit dose 2202 of infusible fluid is administered), the user checks their blood glucose level and realizes that their blood glucose level is running a little higher than normal Accordingly, the user may define an extended bolus infusion event via remote control assembly 300 An extended bolus infusion event may refer to the continuous infusion of a defined quantity of infusible fluid over a finite peπod of time However, as such an infusion methodology is impractical / undesirable for an infusion pump assembly, when administered by such an infusion pump assembly, an extended bolus infusion event may refer to the infusion of additional small doses of infusible fluid over a finite period of time

Accordingly, the user may utilize remote control assembly 300 to define an extended bolus infusion event for the infusible fluid (e g , 020 units over the next six minutes), which may be confirmed in a manner discussed above While, in this example, the extended bolus infusion event is described as 020 units over the next six minutes, this is for illustrative purposes only and is not intended to be a limitation of this disclosure, as either or both of the unit quantity and total time interval may be adjusted upward or downward Once defined and/or confirmed, infusion pump assembly 100, 100' 400, 500 may determine an infusion schedule based upon the extended bolus infusion event defined, and may administer the infusible fluid For example, infusion pump assembly 100, 100' 400, 500 may deliver 0 10 units of infusible fluid every three minutes for the next two interval cycles (or six minutes), resulting in the delivery of the extended bolus dose of infusible fluid defined by the user (i e , 020 units over the next six minutes)

Accordingly, while administering the second, sequential, multi-part, infusion event, infusion pump assembly 100, 100' 400, 500 may infuse a first 0 10 unit dose 2210 of the infusible fluid at t=3 00 (e g , after administering the second 0 05 unit dose 2202 of infusible fluid) Infusion pump assembly 100, 100' 400, 500 may also infuse a second 0 10 unit dose 2212 of the infusible fluid at t=6 00 (e g , after administering the third 005 unit dose 2204 of infusible fluid)

Assume for illustrative purposes only that after the user programs infusion pump assembly 100, 100' 400, 500 via remote control assembly 300 to administer the first sequential, multi-part, infusion event (i e , 0 05 units infused every three minute interval repeated continuously) and administer the second sequential, multi-part, infusion event (i e , 0 10 units infused every three minute interval for two intervals), the user decides to eat a very large meal Predicting that their blood glucose level might increase considerably, the user may program infusion pump assembly 100, 100' 400, 500 (via remote control assembly 300) to admimstera one-time infusion event An example of such a one-time infusion event may include but is not limited to a normal bolus infusion event As is known in the art, a normal bolus infusion event refers to a one-time infusion of the infusible fluid

For illustrative purposes only, assume that the user wishes to have infusion pump assembly 100, 100' 400, 500 administer a bolus dose of thirty-six units of the infusible fluid Infusion pump assembly 100, 100' 400, 500 may monitor the various infusion events being administered to determine whether a one-time infusion event is available to be administered If a one-time infusion event is available for administration, infusion pump assembly 100, 100' 400, 500 may delay the administration of at least a portion of the sequential, multi-part, infusion event

Continuing with the above-stated example, once the user completes the programming of infusion pump assembly 100, 100' 400, 500 to deliver one-time infusion event 2214 (i e , the thirty-six unit bolus dose of the infusible fluid), upon infusion pump assembly 100, 100' 400, 500 determining that the one-time infusion event is available for administration, infusion pump assembly 100, 100' 400, 500 may delay the administration of each sequential, multi-part infusion event and administer the available one-time infusion event

Specifically and as discussed above, pπor to the user programming infusion pump assembly 100, 100' 400, 500 to deliver one-time infusion event 2214, infusion pump assembly 100, 100' 400, 500 was administering a first sequential, multi-part, infusion event (i e , 005 units infused every three minute interval repeated continuously) and administering a second sequential, multi-part, infusion event (i e , 0 10 units infused every three minute interval for two intervals)

For illustrative purposes only, the first sequential, multi-part, infusion event may be represented within FIG 123 as 005 unit dose 2200 @ t=0 00, 005 unit dose 2202 @ t=3 00, 005 unit dose 2204 @ t=6 00, 005 unit dose 2206 @ t=9 00, and 0 05 unit dose 2208 @ t=12 00 As the first sequential, multi-part, infusion event as described above is a basal infusion event, infusion pump assembly 100, 100' 400, 500 may continue to infuse 005 unit doses of the infusible fluid at three minute intervals indefinitely (i e , until the procedure is cancelled by the user)

Further and for illustrative purposes only, the second sequential, multi-part, infusion event may be represented within FIG 123 as 0 10 unit dose 2210 @ t=3 00 and 0 10 unit dose 2212 @ t=6 00 As the second sequential, multi-part, infusion event is described above as an extended bolus infusion event, infusion pump assembly 100, 100' 400, 500 may continue to infuse 0 10 unit doses of the infusible fluid at three minute intervals for exactly two intervals (i e , the number of intervals defined by the user)

Continuing with the above-stated example, upon infusion pump assembly 100, 100' 400, 500 determining that the thirty-six unit normal bolus dose of the infusible fluid (i e , one-time infusion event 2214) is available for administration, infusion pump assembly 100, 100' 400, 500 may delay the administration of each sequential, multi-part infusion event and may start administering one-time infusion event 2214 that is available for administration

Accordingly and for illustrative purposes only, assume that upon completion of the programming of infusion pump assembly 100, 100' 400, 500 to deliver the thirty-six unit normal bolus does of the infusible fluid (i e , the one-time infusion event), infusion pump assembly 100, 100' 400, 500 begins administering one-time infusion event 2214 Being that one-time infusion event 2214 is comparatively large, it may take longer than three minutes (i e , the time interval between individual infused doses of the sequential, multi-part, infusion events) and one or more of the individual infused doses of the sequential, multi-part, infusion events may need to be delayed

Specifically, assume that it will take infusion pump assembly 100, 100' 400, 500 greater than six minutes to infuse thirty-six units of the infusible fluid Accordingly, infusion pump assembly 100, 100' 400, 500 may delay 005 unit dose 2202 (i e , scheduled to be infused @ t=3 00), 005 unit dose 2204 (i e , scheduled to be infused @ t=6 00), and 005 unit dose 2206 (i e , scheduled to be infused @ t=9 00) until after one-time infusion event 2214 (i e , the thirty- six unit normal bolus dose of the infusible fluid) is completely administered Further, infusion pump assembly 100, 100' 400, 500 may delay 0 10 unit dose 2210 (i e , scheduled to be infused @ t=3 00 and 0 10 unit dose 2212 (i e , scheduled to be infused @ t=6 00) until after one-time infusion event 2214

Once administration of one-time infusion event 2214 is completed by infusion pump assembly 100, 100' 400, 500, any discrete infusion events included within the sequential, multipart, infusion event that were delayed may be administered by infusion pump assembly 100, 100' 400, 500 Accordingly, once one-time infiision event 2214 (i e , the thirty-six unit normal bolus dose of the infusible fluid) is completely administered, infusion pump assembly 100, 100' 400, 500 may administer 005 unit dose 2202, 005 unit dose 2204, 005 unit dose 2206, 0 10 unit dose 2210, and 0 10 unit dose 2212

While infusion pump assembly 100, 100' 400, 500 is shown to administer 0 05 unit dose 2202, then 0 10 unit dose 2210, then 005 unit dose 2204, then 0 10 unit dose 2212, and then 005 unit dose 2206, this is for illustrative purposes only and is not intended to be a limitation of this disclosure, as other configurations are possible and are considered to be within the scope of this disclosure For example, upon infusion pump assembly 100, 100' 400, 500 completing the administration of one-time infusion event 2214 (i e , the thirty-six unit normal bolus dose of the infusible fluid), infusion pump assembly 100, 100' 400, 500 may administer all of the delayed discrete infusion events associated with the first sequential, multi-part infusion event (i e , namely 005 unit dose 2202, 005 unit dose 2204, and 005 unit dose 2206) Infusion pump assembly 100, 100' 400, 500 may then administer all of the delayed discrete infusion events associated with the second sequential, multi-part infusion event (i e , 0 10 unit dose 2210, and 0 10 unit dose 2212) While one-time infusion event 2214 (i e , the thirty-six unit normal bolus dose of the infusible fluid) is shown as being infused beginning at t=3 00, this is for illustrative purposes only and is not intended to be a limitation of this disclosure Specifically, infusion pump assembly 100, 100' 400, 500 may not need to begin infusing one-time infusion event 2214 at one of the three-minute intervals (e g , t=0 00, t=3 00, t=6 00, t=9 00, or t=12 00) and may begin administering one-time infusion event 2214 at any time

While each discrete infusion event (e g , 005 unit dose 2202, 005 unit dose 2204, 005 unit dose 2206, 0 10 unit dose 2210, and 0 10 unit dose 2212) and one-time infusion event 2214 are shown as being a single event, this is for illustrative purposes only and is not intended to be a limitation of this disclosure Specifically, at least one of the plurality of discrete infusion events e g , 0 05 unit dose 2202, 005 unit dose 2204, 005 unit dose 2206, 0 10 unit dose 2210, and 0 10 unit dose 2212) may include a plurality of discrete infusion sub-events Further, one-time infusion event 2214 may include a plurality of one-time infusion sub-events

Referring also to FIG 124 and for illustrative purposes, 005 unit dose 2202 is shown to include ten discrete infusion sub-events (e g , infusion sub-events 2216 i io), wherein a 0 005 unit dose of the infusible fluid is infused during each of the ten discrete infusion sub-events Additionally, 0 10 unit dose 2210 is shown to include ten discrete infusion sub-events (e g , infusion sub-events 2218 i ιo), wherein a 001 unit dose of the infusible fluid is delivered duπng each of the ten discrete infusion sub-events Further, one-time infusion event 2214 may include e g , three-hundred-sixty one-time infusion sub-events (not shown), wherein a 0 1 unit dose of the infusible fluid is delivered duπng each of the three-hundred-sixty one-time infusion sub- events The number of sub-events defined above and the quantity of the infusible fluid delivered during each sub-event is solely for illustrative purposes only and is not intended to be a limitation of this disclosure, as the number of sub-events and/or the quantity of the infusible fluid delivered duπng each sub-event may be increased or decreased depending upon e g , the design cπteπa of infusion pump assembly 100, 100' 400, 500

Before, after, or in between the above-descπbed infusion sub-events, infusion pump assembly 100, 100' 400, 500 may confirm the proper operation of infusion pump assembly 100, 100' 400, 500 through the use of any of the above-descπbed safety features (e g , occlusion detection methodologies and/or failure detection methodologies) In the exemplary embodiments, the infusion pump assembly may be wirelessly controlled by a remote control device In the exemplary embodiments, a split πng resonator antenna may be used for wireless communication between the infusion pump assembly and the remote control device (or other remote device) The term "wirelessly controlled" refers to any device that may receive input, instructions, data, or other, wirelessly Further, a wirelessly controlled insulin pump refers to any insulin pump that may wirelessly transmit and/or receive data from another device Thus, for example, an insulin pump may both receive instructions via direct input by a user and may receive instructions wirelessly from a remote controller

Referring to FIG 127, an exemplary embodiment of a split πng resonator antenna adapted for use in a wirelessly controlled medical device, and is used in the exemplary embodiment of the infusion pump assembly, includes at least one split πng resonator antenna (hereinafter "SRR antenna' ) 2508, a wearable electric circuit, such as a wirelessly controlled medical infusion apparatus (hereinafter "infusion apparatus") 2514, capable of powering the antenna, and a control unit 2522

In various embodiments, a SRR antenna 2508 may reside on the surface of a nonconducting substrate base 2500, allowing a metallic layer {or layers) to resonate at a predetermined frequency The substrate base 2500 may be composed of standard printed circuit board mateπal such as Flame Retardant 2 (FR-2), FR-3, FR-4, FR-5, FR-6, G-10, CEM-I, CEM- 2, CEM-3, CEM-4, CEM-5, Polyimide, Teflon, ceramics, or flexible Mylar The metallic resonating bodies compπsing a SRR antenna 2508 may be made of two rectangular metallic layers 2502, 2504, made of, for example, platinum, indium, copper, nickel, stainless steel, silver or other conducting materials In other various embodiments, a SRR antenna 2508 may contain only one metallic resonating body

In the exemplary embodiment, a gold-plated copper outer layer 2502, surrounds, without physically contacting, a gold-plated copper inner πng 2504 That is, the inner πng 2504 resides in the cavity 2510 (or aperture) formed by the outer layer 2502 The inner πng 2504 may contain a gap, or split 2506, along its surface completely seveπng the mateπal to form an incomplete πng shape Both metallic resonating bodies 2502, 2504 may reside on the same planar surface of the substrate base 2500 In such a configuration, the outer layer 2502 may by driven via a transmission line 2512 coupled to the outer layer 2502, for example Additionally, in various other embodiments, a transmission line 2512 may be coupled to the inner πng 2504 Antenna design software, such as AWR Microwave Office, capable of simulating electromagnetic geometries, such as, antenna performance, may significantly decrease the time required to produce satisfactory dimensions compared to physically fabncating and testing antennas Accordingly, with aid of such software, the SRR antenna 2508 may be designed such that the geometric dimensions of the resonant bodies 2502, 2504 facilitate an operational frequency of the 24GHz ISM Band FIG 132 depicts the exemplary dimensions of the inner πng 2504 and outer layer 2502, and the positioning of the cavity 2510 in which the inner πng 2504 resides The distance in between the outer layer 2502 and the inner πng 2504 is a constant 0005 inches along the perimeter of the cavity 2510 However, in other embodiments, the distance between the outer layer and the inner ring may vary and in some embodiments, the operational frequency may vary

In various embodiments, a SRR antenna 2508 may have dimensions such that it could be categorized as electrically small, that is, the greatest dimension of the antenna being far less than one wavelength at operational frequency

In various other embodiments, a SRR antenna 2508 may be composed of one or more alternatively-shaped metallic outer layers, such as circular, pentagonal, octagonal, or hexagonal, surrounding one or more metallic inner layers of similar shape Further, m various other embodiments, one or more metallic layers of a SRR antenna 2508 may contain gaps in the material, forming incomplete shapes

Referring to FIG 130, a SRR antenna 2508 having the exemplary geometry exhibits acceptable return loss and frequency values when placed in contact with human skin As shown in FIG 130, focusing on the band of interest denoted by markers 1 and 2 on the graph, return loss pπor to contact with human skin is near - 15 dB while monitoπng a frequency band centered around 244 GHz ISM Band Return loss duπng contact with human skin, as shown in FIG 130A, remains a suitable value near -25 dB at the same frequency, yielding approximately 97% transmission power

These results are favorable especially as compared with a non-split πng resonator antenna type, such as the Inverted-F Return loss of an Inverted-F antenna may exhibit a difference when the antenna contacts human skin, resulting in a low percentage of power transmitted outward from the antenna By way of example, as shown in FIG 133, and again focusing on the band of interest denoted by markers 1 and 2 on the graph, return loss of an Inverted-F antenna prior to contact with human skin is near -25 dB at a frequency centered around 244 GHz Return loss during contact with human skjn is nearly -2 dB at the same frequency, yielding approximately 37% power transmission

Integration with a Wireless Medical Device

In the exemplary embodiment, referring to FIG 132 and FIG 128, one application of a SRR antenna 2508 may be integration into a wearable infusion apparatus 2514 capable of delivering fluid medication to a user/patient 2524 In such an application, the safety of the user/patient is dependent on fluid operation between these electrical components, thus reliable wireless transmission to and from a control unit 2522 is of great importance

An infusion apparatus 2514 may be worn directly on the human body By way of example, such a device may be attached on or above the hip joint in direct contact with human skin, placing the SRR antenna 2508 at risk of unintended dielectric loading causing a frequency shift in electrical operation However, in such an application, electrical charactenstics of the SRR antenna 2508 which allow it to be less sensitive to nearby parasitic objects are beneficial in reducing or eliminating degradation to the performance A controlling component, such as a control unit 2522 (generally shown in FIG 131), may be paired with an infusion apparatus 2514, and may be designed to transmit and receive wireless signals to and from the infusion apparatus 2514 at a predetermined frequency, which, in the exemplary embodiment, is the 24GHz Industnal Scientific and Medical Band ("ISM band") In the exemplary embodiment, the control unit 2522 serves as the main user interface through which a patient or third party may manage insulin delivery In other embodiments, infusion apparatus 2514 may utilize a SRR antenna 2508 to communicate with one or more control units 2522

In various embodiments, a number of different wireless communication protocols may be used in conjunction with the SRR antenna 2508, as the protocol and data types to be transferred are independent of the electrical characteristics of the antenna However, in the exemplary embodiment, a bi-directional master/slave means of communication organizes the data transfer through the SRR antenna 2508 The control unit 2522 may act as the master by periodically polling the infusion apparatus 2514, or slave, for information In the exemplary embodiment, only when the slave is polled, the slave may send signals to the control unit 2522 only when the slave is polled However, in other embodiments, the slave may send signals before being polled Signals sent by way of this system may include, but are not limited to, control, alarm, status, patient treatment profile, treatment logs, channel selection and negotiation, handshaking, encryption, and check-sum In some embodiments, transmission through the SRR antenna 2508 may also be halted during certain infusion operations as an added precaution against electrical disruption of administration of insulin to the patient

In the exemplary embodiment, the SRR antenna 2508 may be coupled to electrical source circuitry via one or more pins 2516 on a transmission line 2512 In various other embodiments a transmission line may comprise a wire, pairs of wire, or other controlled impedance methods providing a signal path to the SRR antenna 2508 The transmission line 2512 may reside on the surface of the substrate base 2500 and may be composed of the same material as the SRR antenna 2508, such as gold-plated copper Additionally, a ground plane may be attached to the surface of the substrate base opposite the transmission line 2512

The electπcal circuitry coupled to the SRR antenna 2508 may apply an RF signal to the end of the transmission line 2512 nearest the circuitry, creating an electromagnetic field throughout, and propagating from, the SRR antenna 2508 The electπcal circuitry coupled to the SRR antenna 2508 facilitates resonance at a predetermined frequency, which, in the exemplary embodiment, is the 24GHz ISM band Preferably, transmission line 2512 and SRR antenna 2508 both have impedances of 50 Ohms to simplify circuit simulation and characterization However, in other vaπous embodiments, the transmission line and split πng resonator antenna may have other impendence values, or a different resonating frequency

Referring to FIG 129, a signal processing component(s) 2518, such as, a filter, amplifier, or switch, may be integrated into the transmission line 2512, or at some point between the signal source connection pins 2516 and the SRR antenna 2508 In the exemplary embodiment, the signal processing component 2518 is a band-pass filter to facilitate desired signal processing, such as, allowing only the exemplary frequency to be transmitted to the antenna, and rejecting frequencies outside that range In the exemplary embodiment, a Combline band-pass filter 2518 may be included in the transmission line 2512 between the antenna and the signal source However in other embodiments, any other signal processing device, for example, but not limited to, filters, amplifiers, or any other signal processing devices known in the art

In vaπous embodiments, a SRR antenna 2508 may be composed of metallic bodies capable of resonating on a flexible or rigid substrate As shown in FIG 128 and FIG 129, the exemplary embodiment incorporates a curved SRR antenna on a flexible Polyimide substrate 2520 Polyimide may be the exemplary material because it tends to be more flexible than alternative substrates This configuration may allow for simplified integration into circular- shaped devices (such as a wirelessly controlled medical infusion apparatus 2514), devices with irregular-shaped external housing, or devices in which saving space is paramount

In various embodiments, both control unit 2522 and base unit 2514 may incorporate a split SRR antenna 2508 This configuration may prove beneficial where the control unit is meant to be handheld, in close proximity to human skin, or is likely to be in close proximity to a varying number of mateπals with varying dielectric constants

In various other embodiments, a SRR antenna 2508 may be integrated into a human or animal limb replacement As prosthetic limbs are becoming more sophisticated the electrical systems developed to control and simulate muscle movements require much more wiring and data transfer among subsystems Wireless data transfer within a prosthetic limb may reduce weight through reduced physical wiπng, conserve space, and allow greater freedom of movement However, common antennas in such a system may be susceptible to dielectric loading Similar to the previously mentioned benefits of integrating a SRR antenna 2508 into a wirelessly controlled medical infusion apparatus, a prosthetic limb, such as a robotic arm, may also come into contact with human skin or other dielectric materials and benefit from the reduction of electncal disturbances associated with such an antenna In other vaπous embodiments, the SRR antenna 2508 may be integrated into any device compπsed of the electrical components capable of powenng and transmitting/receiving data to an antenna and susceptible to electrical disturbances associated with proximity to dielectric mateπals

In vaπous embodiments, a SRR antenna 2508 may be integrated into a configuration of medical components in which one or more implantable medical devices, operating within the human body, communicate wirelessly to a handheld, body-mounted, or remote control unit In certain embodiments, both body-mounted and in-body wireless devices may utilize a SRR antenna 2508 for wireless communication Additionally, one or more of the components utilizing a SRR antenna 2508 may be completely surrounded by human skin, tissue or other dielectπc material By way of example, such a configuration may be used in conjunction with a heart momtoπng/control system where stability and consistency of wireless data transmission are of fundamental concern In various other embodiments, a SRR antenna 2508 may be integrated into the embodiments of the infusion pump assembly In some embodiments, the SRR antenna 2508 may be integrated into a configuration of medical components in which one or more electrical sensors positioned on, or attached to, the human body wirelessly communicate to a remote transceiving unit By way of example, a plurality of electrodes positioned on the body may be coupled to a wireless unit employing a SRR antenna 2508 for wireless transmission to a remotely located electrocardiogram machine By way of further example, a wireless temperature sensor in contact with human skin may employ SRR antenna 2508 for wireless communication to a controller unit for temperature regulation of the room in which the sensor resides System for Verification of Volume and Pumping

Infusion pump therapy includes volume and time specifications The amount of fluid dispensed together with the dispense timing are two cπtical factors of infusion pump therapy As discussed in detail below, the infusion pump apparatus and systems shown and descnbed herein provide for a method of dispensing fluid together with a device, system and method for measuπng the amount of fluid dispensed However, in a circumstance where the calibration and precision of the measurement device calibration is critical, there are advantages to determining any compromise in the precision of the measurement device as soon as possible Thus, there are advantages to off-board verification of volume and pumping

As shown in the figures, the disposable assembly includes a reservoir for holding the infusible fluid for pumping There are various methods and devices for filling the reservoir with infusible fluid, many embodiments are discussed above An additional embodiment and system for both verifying the volume of fluid filled in the reservoir and verifying the integrity of the pumping system is discussed below

In one embodiment, a weight scale is used to determine the volume of fluid filled into the disposable and may also be used for verification by comparing the before-use volume with the after-use volume of the disposable In some embodiments, this is accomplished by weighing the disposable before and after reservoir filling is complete In some embodiments, the weight scale may be reset to zero) (i e , tared) to the disposable pπor to filling In other embodiments, a weight may be taken before the fill and afterwards In some embodiments, a processor may calculate the weight of the fluid filled and correlate the weight to a volume of fluid In some embodiments, the display on the scale may automatically display the volume of fluid that has been filled in the reservoir The method of filling may be any discussed above, or an automatic fill, as discussed below In addition, in some embodiment, a pre-filled reservoir may be used and thus, filling is not necessary, rather, the weight would be taken pπor to loading the reservoir and after reservoir loading

An exact calculation of the volume of fluid in a reservoir may be used to verify the measurement system of the pumping device For example, following the use of the disposable, where the system either stores, or, receives via an input the before-use weight at fill of the disposable, the system, taking the after-use weight, may determine the volume of fluid difference between before-use and after-use This information may be used as a check to the pumping system to verify the amount of fluid pumped from the given reservoir

Additionally, the exact volume of fluid filled may be entered into the pumping system which may be used by the system to warn the user of low- volume reservoir or present to the user an accurate volume of fluid remaining in the reservoir at any given time

Referring now to FIG 205, one embodiment of the system includes a combination charger, disposable fill and integrity verification station 2900 The charger station 2900 includes a charging section 2902 for a reusable assembly, a charging section 2904 for a remote control device, and a weight scale 2906 The weight scale 2906 in some embodiments may be sized to accommodate a disposable assembly 2908 In the exemplary embodiment, the station also includes a fill adapter septum 2910 that accepts a filling cap 2912 (including a filling needle for piercing the septum 2910) In some embodiments, the filling needle is attached to a fluid line 2914 which may be a flexible tubing of a predetermined length suitable for reaching around the station 2900 to, in some embodiments, a fluid vial or fluid container holder 2916 The container holder 2916 may be sized to accommodate a fluid vial 2918 In addition to the features shown in FIG 205, in some embodiments, the station 2900 may include a pump for pumping the fluid from the container 2918 into the disposable assembly 2908 In some embodiments, the pump may be a peristaltic pump However, in other embodiments, the pump may be a diaphragm pump or any of pump known in the art The pump may be used to automatically fill the reservoir in the disposable 2908 In some embodiment, a user attaches the container cap 2920 (including a needle) to the fluid container 2918 as well as the filling cap 2912 to the fill adapter septum 2910 The pump evacuates air from the disposable and uses it to pressurize the vial The pump then pulls fluid from the container 2918 and fills the disposable 2908 reservoir Also, whilst filling the reservoir, the system may provide enough positive pressure to additionally pπme the fluid path and the cannula of the disposable

In some embodiments, the station 2900 may also include a display for communication to a user of the volume of fluid currently in the disposable 2908 This may be used to fill the reservoir to a desired volume Additionally, in some embodiments, the station 2900 may wirelessly communicate to a remote controller (not shown) or other device, the volume of fluid filled into the reservoir In some embodiments, when a user is finished with a disposable, the user will weight the after-use disposable The system will communicate with the pumping system and correlating the data, an integrity verification test may be performed Where a system integrity error is determined, the system may alarm the user appropπately

In other embodiments, a station may include a weight scale and any one or more of the various other components of the station 2900 as discussed above Still referring to FIG 205, the system may be portable and the scale portion 2922 may slide into the charger portion 2924, protecting the integrity of the scale as well as providing convenient portability

Thus, this system has many benefits, including, but not limited to, off-board integrity verification of volume sensing at each disposable change, accurate determination of volume at fill to both accurately track current reservoir volume and thus alarm user when volume is low, method for avoiding under-desired-volume filling or over-desired-volume filling, method of filling a disposable with fluid while also pre-pπmmg (or purging the air) the disposable fluid line, and verification of volume regardless of disposable manufacture variability

While the principles of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention

APPARATUS, SYSTEM AND METHOD FOR FLUID DELIVERY

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Non-Provisional Patent Application which claims priority from the following U.S. Provisional Patent Applications both of which are hereby incorporated herein by reference in its entirety:

U.S. Provisional Patent Application Seria! No. 61/142,042, filed December 31, 2008 and entitled Method, System and Apparatus for Verification of Volume and Pumping (Attorney Docket No. G78): and U.S. Provisional Patent Application Serial No, 61/225,794, filed July 15, 2009 and entitled Infusion Pump Assembly (Attorney Docket No. ! (48).

FIELD OF THE INVENTION

This application relates generally to fluid delivery systems, and more particularly to apparatus, system and method for fluid delivery.

BACKGROUND OF THE INVENTION

Many potentially valuable medicines or compounds, including biologkals, are not orally active due to poor absorption, hepatic metabolism or other pharmacokinetic factors. Additionally, some therapeutic compounds, although they can be orally absorbed, are sometimes required to be administered so often it is difficult for a patient to maintain the desired schedule, In these cases, parenteral delivery is often employed or could be employed. Effective parenteral routes of daig deliver)', as well as other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous {IV} administration include puncture of the skin with a needle or stylet, insulin Ls an example of a therapeutic fluid thai is self-injected by millions of diabetic patients. Users of parenteral!}-¹ delivered drugs may benefit from a wearable device that would automatically deliver needed drugs/compounds over a period of time. To this end, there have been efforts io design portable and wearable devices for the controlled release of therapeutics. Such devices are known to have a reservoir such as a cartridge, syringe, or bag, and to be electronically controlled. These devices sutler from a number of drawbacks including ihe malfunction rate. Reducing the size, weight and cost of these devices is also an ongoing challenge. Additionally, these devices often apply to the skin and pose the challenge of frequent re-location for application.

SUMMARY OF THE INVENTION

in accordance with one aspect of ihe present invention a fill adapter system for an infusion pump assembly is disclosed. The system includes a reusable fill adapter base, the base including a volume control mechanism to adjust an available fill volume of a reservoir of the infusion pump assembly and a pump mechanism eon figured to pump air into a Fluid vial. The system also includes a vial adapter assembly including a first needle configured to penetrate a septum of the fluid vial for flu id Iy coupling the pump mechanism to the fluid vial and a second needle having a first end configured to penetrate the septum of the fluid vial and a second end configured to penetrate a septum of the reservoir of the infusion pump assembly to allow transfer of fluid from the fluid via! to the reservoir of the infusion pump assembly in response to air being pumped into the fluid vial and a needle carriage adapted to carry the first needle and the second needle, wherein the needle carriage slidably attached to the interior of the via! adapter assembly, wherein the needle carriage adapted to slide from a via! end of the vial adapter to a receptacle end of the viai adapter.

Some embodiments of this aspect of the invention include one or more of the following. Wherein the vial adapter assembly further includes a hydrophobic filter within a fluid path of the first needie. Wherein the volume control mechanism further includes a turn dial and a push plate, wherein the turn dial actuates the push plate and wherein the push plate adjusts the available fill volume of a reservoir of the infusion pump assembly. Wherein the filling system further includes a weight scale, the weight scale determining the weight of^" the infusion pump assembly before tilling a volume a fluid and the weight scale determining the weight of the infusion pump assembly after the reservoir is filled to a volume. In accordance with one aspect of the present invention a filling system for an infusion pump assembly is disclosed. The system includes a volume control mechanism configured to adjust an available fill volume of a reservoir of the infusion pump assembly, a pump mechanism configured to pump air into a fluid via! via a first needle, the first needle configured to penetrate a septum of the fluid vial for fluid Iy coupling the pump mechanism to the fluid vial, and a second needle having a first end configured to penetrate flic septum of the fluid vial and a second end configured to penetrate a septum of the reservoir of the infusion pump assembly to allow transfer of fluid from the fluid via! to the reservoir of the infusion pump assembly in response to air being pumped into the fluid vial Some embodiments of this aspect of the invention include one or more of the following.

Wherein the volume control mechanism further includes a turn dial and a push plate, wherein the turn dial actuates the push plate and wherein the push plate adjusts the available fill volume of a reservoir of the infusion pump assembly in accordance with one aspect of the present invention a via! adapter. The vial adapter includes a housing having a vial end and a receptacle end and interior wall features, a needle carriage siidabiy attached to the interior of the housing, and a disc slidabSy attached to the interior of the housing, the disc having a first position on the receptacle end of the housing and a second position on the vial end of the housing and configured to raatably attach to the needle carriage.wherein the needle carriage matabiy attaches to the disc and the needle carriage and disc slide to the vial end of the housing and wherein the disc is locked into a position on the vial end by interior wall features of the housing.

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, the drawings, and the claims.

BR! EF I)ESCRl PTION OF THE DRAWINGS

FIG. 1 is a side view of an infusion pump assembly;

FlG. 2 is a perspective view of the infusion pump assembly of FlG. 1 ; FlG, 3 is an exploded view of various components of the infusion pump assembly of FIG. ! ;

F(G. 4 is a cross-sectional view of the disposable housing assembly of the infusion pump assembly of FIG. I; FIGS. 5A-5C are cross-sectional views of an embodiment of a septum access assembly;

FiGS. 6A-6B are cross-sectional views of another embodiment of a septum access assembly;

HGS. 8A-8B are cross-sectional views of another embodiment of a septum access assembly:

FIG. 9 is a perspective view of the infusion pump assembly of FfG. 1 showing an external infusion set; RGS. 1 OA- 1 OE depict a plurality of hook-and-loop fastener configurations;

FIGS. H B-I lR depicts various views of high level schematics and flow charts of the infusion pomp assembly of FIG. I : FiGS. 12A- ! 2F is a plurality of display screens rendered by the remote control assembly of FlG. 1 1 A;

FIG. 13 is an isometric view of an alternative embodiment of the infusion pump assembly of FIG. 1;

FIG. 14 is an isometric view of the infusion pump assembly of FlG. 13; FIG. 15 is an isometric view of the infusion pump assembly of FlG. 13:

FfG. 16 is an isometric view of an alternative embodiment of the infusion pump assembly of FlG. k

FIG. 17 is an plan view of the infusion pump assembly of FlG. 16:

FIG. IS is a plan view of the infusion pump assembly of FlG. 16: FfG. 19 A is an exploded view of various components of the infusion pump assembly of FIG. 16:

FIG. 19B is an isometric view of a portion of the infusion pump assembly of FiG. 16; FlG, 20 is a cross-sectional view of the disposable housing assembly of the infusion pump assembly of FlG. 16;

F(G. 21 is a diagrammatic view of a fluid path within the infusion pump assembly of FICi. 16: FIGS. 22A-22C are diagrammatic views of a fluid path within the infusion pump assembly of RG. 16;

FlG. 23 is an exploded view of various components of the infusion pump assembly of FIG. 16:

FlG, 24 is a cutaway isometric view of a pump assembly of the infusion pump assembly of FKl 16;

RGS. 25A-25D are other isometric views of the pump assembly of FiG. 24;

FlG. 26A-26B are isometric views of a measurement valve assembly of the infusion pump assembly of FIG. 16;

FfG, 27A-27B are side views of the measurement valve assembly of FIGS. 26A- 26B;

FiG. 29 is an isometric view of an alternative embodiment of the infusion pump assembly of FIG. 1; FlG. 30 is an isometric view of an alternative embodiment of the infusion pump assembly of FlG. 1 ;

FlG. 32 is an exploded view of another embodiment of an infusion pump assembly; FlG. 33 is another exploded view of the infusion pump assembly of FiG. 32;

FIGS. 34A-34B depict another embodiment of an infusion pump assembly;

FIGS. 35A-35C are a top view, side view, and bottom view of a reusable housing assembly of the infusion pump assembly of FiGS. 32;

FlG. 36 is an exploded view of the reusable housing assembly of FIGS. 35A-35C; FIG. 3? is an exploded view of the reusable housing assembly of FΪGS. 35A-35C:

FiG. 38A is an exploded view of the reusable housing assembly of FIGS. 35A-35C;

FlG. 38B-38D are lop, side and bottom views of one embodiment of a dυsi cover: FIGS. 39A-39C are a top view, side view, and bottom view of an electrical control assembly of the reusable housing assembly of FIGS. 35A-35C;

F-IGS, 40A-4OC are a top view, side view, and bottom view of a base plate of the reusable housing assembly of^* FIGS. 35A-35C: FIGS. 41 A-41B are a perspective top view and a perspective bottom view of the base plate of FfGS. 40A-40C:

FiGS. 42A-42C are a top view, side view, and bottom view of a base plate of the reusable housing assembly of FIGS. 35A-35C;

FIGS. 43Λ-438 depict a mechanical control assembly of the reusable housing assembly of FIGS. 3SA-35C;

HGS. 44A-44C depict the mechanical control assembly of the reusable housing assembly of FIGS, 35A-35C;

FIGS. 45 A -458 depict the pump plunger and reservoir valve of the mechanical control assembly of the reusable housing assembly of FIGS. 35A-35C; RGS. 46A-46E depict various views of the plunger pump and reservoir valve of the mechanical control assembly of the reusable housing assembly of FIGS. 33A-35C;

FIGS. 47A-47B depict the measurement valve of the mechanical control assembly of the reusable housing assembly of FIGS. 35A-35C;

FIG. 48 is an exploded view of the disposable housing assembly of the infusion pump assembly of FlG. 32;

FIG. 49A is a plan view of the disposable housing assembly of FICl- 48;

FIG. 49 B is a sectional view of the disposable housing assembly of FlCi. 49A taken along line B-B;

RG. 49C is a sectional view of the disposable housing assembly of FIG. 49A taken along line C-C;

FIGS. 50A-50C depict the base portion of the disposable housing assembly of RC!. 48;

FIGS. 51Λ-51C depict the fluid pathway cover of the disposable housing assembly of FIG. 48; FIGS. 52A-52C depict the membrane assembly of the disposable housing assembly of FIG. 48;

FIGS. 53A-53C depict the top portion of the disposable housing assembly of FKJ. 48; FIGS. 54A-54C depict the valve membrane insert of the disposable housing assembly of FΪG. 48;

F-(GS, 55A-55B depict the locking ring assembly of the infusion pump assembly of FICi. 32; FiG, 56A-56B depict the locking ring assembly of the infusion pump assembly of

FIG. 32;

FiGS. 57-58 is an isometric view of an infusion pump assembly and a fill adapter;

FSGS. 59-64 are various views of the fύ\ adapter of RG. 57;

FiG. 65 is an isometric view of another embodiment of a fill adapter; FIGS. 66-67 depict an infusion pump assembly and another embodiment of a fill adapter;

FIGS, 68-74 are various views of the fill adapter of FiG. 66;

FiGS. 75-SO depict various views of an embodiment of a battery charger;

FfGS. 8 ! -89 depict various embodiments of battery chargers / docking stations; RGS. 90A-90C are various views of a volume sensor assembly included within the infusion pump assembly of FIG, 1;

FIGS. 91 A-91! are various views of a volume sensor assembly included within the infusion pump assembly of FIG. 1;

FIGS. 92A-92I are various views of a volume sensor assembly included within the infusion pump assembly of FIG. ! ;

FIGS. 93A-93I are various views of a volume sensor assembly included within the infusion pump assembly of RG. 1;

FIG, 96 is a diagrammatic view of a volume sensor assembly included within the infusion pump assembly of FiG. 1 ;

FIG. 97 is a two-dimensional graph of a performance characteristic of the volume sensor assembly of FIG. %:

FiG, 98 is a two-dimensional graph of a performance characteristic of the volume sensor assembly of FlG, 96; FlG, 99 is a two-dimensional graph of a performance characteristic of the volume sensor assembly of FIG. %;

F⁽G. 100 is a diagrammatic view of a volume sensor assembly included within the infusion pump assembly of FIG, 1; FIG, 101 is a two-dimensional graph of a performance characteristic of the volume sensor assembly of FSG. i 00;

FiG. 101 is a two-dimensional graph of a performance characteristic of the volume sensor assembly of FlG, 1 (K);

FlG, 103 is a diagrammatic view of a volume sensor assembly included within the infusion pump assembly of F(G. 1 ;

FIG. 104 is a two-dimensional graph of a performance characteristic of a volume sensor assembly included within the infusion pump assembly of HG. I ;

FIG. 105 is a two-dimensional graph of a performance characteristic of a volume sensor assembly included within the infusion pump assembly of FlG. 1 : HG. 106 is a two-dimensional graph of a performance characteristic of a volume sensor assembly included within the infusion pump assembly of FlG, 1 ;

FIG. 108 is a two-dimensional graph of a performance characteristic of a volume sensor assembly included within the infusion pump assembly of FlG. 1 :

FIG. 109 is a diagrammatic view of a control model for a volume sensor assembly included within the infusion pump assembly of FlG. 1;

FiG. 1 10 is a diagrammatic view of an electrical control assembly for the volume sensor assembly included within the infusion pump assembly of FIG, I ; FIG. I l l is a diagrammatic view of a volume controller for the volume sensor assembly included within the infusion pump assembly of FIG. I ;

FlG, ! 12 is a diagrammatic view of a feed forward controller of the volume controller of FlG. I l l;

FIGS, 1 13-1 14 diagrammatieally depicts an implementation of an SMA controller of the volume controller of FIG. I l l;

FlG. 1 14A-! 14B is an alternate implementation of an SMA controller;

FlG, 1 15 diagrammatieally depicts a multi-processor control configuration that may be included within the infusion pump assembly of FIG. 1; FlG, 1 16 is a diagrammatic view of a multi-processor control configuration thai may be included within the infusion pump assembly of FlG. t;

F(G. 1 17A- J !7B diagrammatic-ally depicts multi-processor functionality;

FiG. 1 18 diagrammatical!}' depicts multi-processor functionality; FiG, 1 19 diagrammatical!}' depicts multi-processor functionality;

RGS. 120A- !2OK graphically depicts various software layers;

120B- 12OC depict various state diagrams;

I 20O graphical Iy depicts device interaction;

!2OE graphically depicts device interaction; FlG, 121 diagrammatJcaSiy depicts a volume sensor assembly included within the infusion pump assembly of FiG. 1 ;

FlG. 122 diagrarnrnaticaliy depicts an inter-connection of the various systems of the infusion pump assembly of FlG. 1 ;

FfG, 123 diagrammatical!}' depicts basal - bolus infusion events; RG. 124 diagrammatical!}' depicts basal - bolus infusion events;

FlG. I25AI2G depicts a hierarchial state machine;

FIG. 126A-126M depicts a hierarchial state machine;

FiG. 12? is an exemplary diagram of a spϊϊt ring resonator antenna;

FlG. 128 is an exemplary diagram of a medical device configured to utilize a split ring resonator antenna;

FIG. 129 is an exemplary diagram of a splii ring resonator antenna and transmission line from a medical infusion device;

FiG. 130 is a graph of the return loss of a split ring resonator antenna poor to contact with human skin; FlG. 130A is a graph of the return loss of a split ring resonator antenna during contact with human skin;

FlG, 13 ! is an exemplary diagram of a split ring resonator antenna integrated into a device which operates within close proximity to dielectric material;

FlG. 132 is a diagram of the dimensions of the inner and outer portion of the exemplary embodiment;

FiG. 133 is a graph of the return loss of a non-split ring resonator antenna prior to contact with human skin; FlG, 133 A i$ a graph of the return loss of a non-split ring resonator antenna during contact with human skin;

F-(GS, 134 - i45 depict an embodiment of a charger, including various perspective views, exploded views, and partial Sy exploded views; FΪGS. 146-148 are schematics of an exemplary electrical system that may be utilised in connection with the charger of FSGS. 134- 145;

FiGS. 149-173 show various additional embodiments of a charger, as well as various features of such additional embodiments;

FIGS. 174-193 depict various views and aspects of an embodiment of a iϊll adapter; FIGS, i 94- i 98 depict various views and aspects of another embodiment of a fill adapter;

FIGS, 199A-IWH depicts a sequential cross sectional view of one embodiment of the fill adapter in operation;

FfG, 200 is an exploded view of one embodiment of a fill adapter; RG. 201 is an isometric view of a fill adapter base according to one embodiment;

FlG. 205 shows one embodiment of a system for verification of volume and pumping.

Like reference symbols in the various drawings indicate Nice elements.

DETAILED DESCRf PHON OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1-3, an infusion pump assembly 100 may include a reusable housing assembly 102, Reusable housing assembly 102 may be constructed from any suitable material, such as a hard or rigid plastic, that will resist compression. For example, use of durable materials and parts may improve quality and reduce costs by providing a reusable portion that !a.sts longer and is more durable, providing greater protection to components disposed therein. Reusable housing assembly 102 may include mechanical control assembly 104 having a pump assembly S 06 and at least one valve assembly 108. Reusable housing assembly 102 may also include electrical control assembly I S O configured to provide one or more control signals to mechanical control assembly 104 and effectuate the basal and/ or bolus delivery of an infusible tluid to a user. Disposable housing assembly 1 14 may include valve assembly 108 which may be configured to control the How of the infusible fluid through a fluid path. Reusable housing assembly 102 may also include pump assembly 106 which may be configured Io pump the infusible fluid from the fluid path to the user.

Electrical control assembly 1 10 may monitor and control ihe amount of infusible fluid that has been and/or is being pumped. For example, electrical control assembly 1 f 0 may receive signals from volume sensor assembly 148 and calculate the amount of infusible fluid that lias just been dispensed and determine, based upon the dosage required by ihe user, whether enough infusible fluid has been dispensed. If enough infusible fluid has not been dispensed, electrical control assembly I IO may determine that more infusible fluid should be pumped. Electrical control assembly 1 10 may provide the appropriate signal to mechanical control assembly 104 so that any additional necessary dosage may be pumped or electrical control assembly 1 10 may provide ihe appropriate signal to mechanical control assembly 104 so that ihe additional dosage may be dispensed with the next dosage. Alternatively, if too much infusible fluid has been dispensed, electrical control assembly 1 10 may provide the appropriate signal to mechanical control assembly 104 so that less infusible fluid may be dispensed in ihe next dosage.

Mechanical control assembly 104 may include at least one shape-memory actuator 1 12. Pump assembly S 06 and/or valve assembly 108 of mechanical control assembly J 04 may be actuated by at least one shape-memory actuator, e.g., shape-memory actuator 1 12, which may be a shape-memory wire in wire or spring configuration. Shape memory actuator 1 12 may be uperably connected to and activated by electrical control assembly 1 10, which may control the timing and the amount of heat and/or electrical energy used to actuate mechanical control assembly i 04, Shape memory actuator 1 12 may be, for example, a conductive shape-memory alloy wire that changes shape with temperature. The temperature of shape-memory actuator 1 12 may be changed with a heater, or more conveniently, by application of electrical energy. Shape memory actuator 1 12 may be a shape memory wire constructed of nickel/titanium alloy, such as Ni^'ilNOL™ or

FLEXΓNOL®. Infusion pump assembly 100 may include a volume sensor assembly 148 configured to monitor the amount of fluid infused by infusion pump assembly 100. For example, volume sensor assembly 148 may employ, for example, acoustic volume sensing. Acoustic volume measurement technology is the subject of U, S, Patent Nos. 5,575,310 and 5,755,683 assigned to DEKA Products Limited Partnership, as well as U.S. patent application

Publication Nos. US 2007/022807 ) A L US 2007/02104% AI, US 2007/0219480 AL US 2007/021959T AL the entire disclosures of all of which are incorporated herein by reference. Other alternative techniques for measuring fluid How may also be used; for example, Doppler-based methods; the use of Hall-effect sensors in combination with a vane or flapper valve; the use of a strain beam (for example, related to a flexible member over a fluid reservoir to sense deflection of the flexible member); the use of capaeitive sensing with plates; or thermal time of flight methods. One such alternative technique is disclosed in U.S. Patent app Heat ion Serial No, 1 1/704,899, entitled Fluid Deliver}' Systems and Methods, filed 09 February 2007, the entire disclosure of which is incorporated herein by reference, infusion pump assembly 100 may be configured so that the volume measurements produced by volume sensor assembly 148 may be used to control, through a feedback loop, the amount of infusible fluid thai is infused into the user.

Infusion pump assembly 100 may further include a disposable housing assembly 1 14. For example, disposable housing assembly 1 14 may be configured for a single use or for use for a specified period of time, e.g., three days or any other amount of time.

Disposable housing assembly 1 14 may be configured such that any components in infusion pump assembly 100 that come in contact with the infusible fluid arc disposed on and/or within disposable housing assembly 1 14. For example, a fluid path or channel including a reservoir, may be positioned within disposable housing assembly 1 14 and may be configured for a single use or for a specified number of uses before disposal. The disposable nature of disposable housing assembly 1 14 may improve sanitation of infusion pump assembly 100.

Referring also to FKJ-. 4, disposable housing assembly 1 14 may be configured to reieasably engage reusable housing assembly 102, and includes a cavity 1 16 that has a reservoir 1 18 for receiving an infusible fluid (not shown), e.g., insulin. Such releasable engagement may be accomplished by a screw-on, a twist-lock or a compression tit configuration, for example. Disposable housing assembly 1 14 and/or reusable housing assembly 102 may include an alignment assembly configured to assist in aligning disposable housing assembly ! Ϊ4 and reusable housing assembly 102 for engagement in a specific orientation. Similarly, base nub 120 and top nub 122 may be used as indicators of alignment and complete engagement.

Cavity I 16 may be at least partially formed by and integral to disposable housing assembly S 14. Cavity 1 16 may include a membrane assembly 124 for at least partially defining reservoir i 18. Reservoir I i S may be further defined by disposable housing assembly 114, e.g., by a recess 126 formed in base portion 128 of disposable housing assembly 1 14. For example, membrane assembly 124 may be disposed over recess 126 and attached to base portion 128, thereby forming reservoir 1 IS, Membrane assembly 124 may be attached to base portion 128 by conventional means, such as gluing, heat sealing, and/or compression fitting, such that a seal 130 is formed between membrane assembly 124 and base portion 128. Membrane assembly 124 may be flexible and the space formed between membrane assembly 124 and recess 126 in base portion 128 may define reservoir 1 S 8, Reservoir 1 18 may be non-pressurized and in fluid communication with a fluid path (not shown). Membrane assembly 124 may be at least partially collapsible and cavity 1 16 may include a vent assembly, thereby advantageously preventing the buildup of a vacuum in reservoir 1 18 as the infusible fluid is delivered from reservoir 118 to the fluid path. In a preferred embodiment, membrane assembly 124 is fully collapsible, thus allowing for the complete delivery of the infusible fluid. Cavity 1 16 may be configured to provide sufficient space to ensure there is always some air space even when reservoir 1 1 S is tilled with infusible fluid.

I^'Sie membranes and reservoirs described herein may be made from materials including but not limited to silicone, N ITR !LE, and any other material having desired resilience and properties for functioning as described herein. Additionally, other structures could serve the same purpose.

The use of a partially collapsible non pressurized reservoir may advantageously prevent the buildup of air in the reservoir as the fluid in the reservoir is depleted. Air buildup in a vented reservoir could prevent fluid egress from the reservoir, especially if the system is tilted so that an air pocket intervenes between the fluid contained in the reservoir and the septum of the reservoir. Tilting oft.be system is expected during normal operation as a wearable device.

Reservoir 1 18 may be conveniently sized to hold an insulin supply sufficient for delivery over one or more days. For example, reservoir 118 may hold about 1.00 to 3.00 ml of insulin. A 3.00 mi insulin reservoir may correspond to approximately a three day supply for about 90% of potential users. In other embodiments, reservoir ! 18 may he any size or shape and may be adapted to hold any amount of insulin or other infusible fluid. In some embodiments, the size and shape of cavity i 16 and reservoir HS is related to the type of infusible fluid that cavity 1 16 and reservoir 1 18 are adapted to hold.

Disposable housing assembly S 14 may include a support member 132 ( FKJ. 3) configured to prevent accidental compression of reservoir 1 IS. Compression of reservoir i 18 may result in an unintentional dosage of infusible fluid being forced through the fluid path to the user. In a preferred embodiment, reusable housing assembly 102 and disposable housing assembly 1 14 may be constructed of a rigid materia! that Ls not easily compressible. However, as an added precaution, support member 132 may be included within disposable housing assembly ! 14 to prevent compression of in fusion pump assembly 100 and cavity ! 16 therein. Support member 132 may be a rigid projection from base portion !2S. For example, support member 132 may be disposed within cavity 1 16 and may prevent compression of reservoir 1 18.

As discussed above, cavity 1 16 may be configured to provide sufficient space to ensure there is always some air space even when reservoir 1 18 is filled with infusible fluid. Accordingly, in the event that infusion pump assembly 100 is accidentally compressed, the infusible fluid may not be forced through cannula assembly 136 {e.g., shown in FlG. 9). Cavity 1 16 may include a septum assembly 146 (FlG. 3) configured to allow reservoir 1 I S to be filled with the infusible fluid. Septum assembly 146 may be a conventional septum made from rubber or plastic and have a one-way fluid valve configured to allow a user to fill reservoir 1 18 from a syringe or other filling device. In some embodiments, septum 146 may be located on the top of membrane assembly 124. In these embodiments, cavity 1 16 may include a support structure (e.g., support member 132 in FIG. 3) for supporting the area about the back side of the septum so as to maintain the integrity of the septum sea! when a needle is introducing infusible fluid into cavity ! 16. Hie support structure may be configured to support the septum while still allowing the introduction of the needle for introducing infusible fluid into cavity 1 16. Infusion pump assembly 100 may include an overfill prevention assembly (not. shown) that may e.g., protrude into cavity 116 and may e.g., prevent the overfilling of reservoir 1 18. In some embodiments, reservoir 1 18 may be configured to be filled a plurality of times. For example, reservoir 1 18 may be refiliahle through septum assembly 146. As infusible fluid may be dispensed to a user, electronic control assembly 1 10 may monitor the fluid level of the infusible fluid in reservoir 1 18. When the fluid level readies a low point, electronic control assembly 1 10 may provide a signal, such as a light or a vibration, to the user that reservoir 118 needs to be refilled. A syringe, or other filling device, may be used to fill reservoir I S 8 through septum 146,

Reservoir 1 1 S may be configured to he filled a single time. For example, a refill prevention assembly tnot shown) may be utilized to prevent the refilling of reservoir 1 18_; such that disposable housing assembly 1 14 may only be used once. The refill prevention assembly (not shown I may be a mechanical device or an electro-mechanical device, for example, insertion of a syringe into septum assembly 146 for filling reservoir 1 18 may trigger a shutter to close over septum 146 after a single filling, thus preventing future access to septum 146, Similarly, a sensor may indicate to electronic control assembly 1 10 that reservoir 1 18 has been filled once and may trigger a shutter to close over septum 146 after a single filling, thus preventing future access to septum 146. Other means of preventing refilling may be utilized and are considered io be within the scope of this disclosure,

As discussed above, disposable housing assembly 1 14 may include septum assembly 146 that may be configured to allow reservoir S 18 to be filled with the infusible fluid. Septum assembly 146 may be a conventional septum made from rubber or any other material (.hat may function as a septum, or, in other embodiments, septum assembly 146 may be, but is not limited to, a plastic, or other material, one-way fluid valve. In various embodiments, including the exemplar}_' embodiment, septum assembly 146 is configured to allow a user to fill reservoir 1 18 from a syringe or other filling device. Disposable housing assembly 1 14 may include a septum access assembly that may be configured to limit the number of times that the user may refill reservoir 1 18.

For example and referring also to FIGS, 5A-5C, septum access assembly 152 may include 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 penetrating septum 146 with filling syringe 160, shutter assembly 154 may be displaced downward, resulting in tab assembly 156 disengaging from slot assembly 15 S. Once disengaged, spring assembly 162 may displace shutter assembly 154 in the direction of arrow 164, resulting in septum 146 no longer being accessible to the user. Referring also to FlG. 6A, an alternative-embodiment septum access assembly 166 is shown in the "open" position. In a fashion similar to that of septum access assembly 152, septum access assembly 166 includes shutter assembly 168 and spring assembly 1 70.

Referring also to FlG. 6B, an alternative-embodiment of septum access assembly 172 is shown in the "open'^' position where tab 178 may engage slot 180, In a fashion similar to that of septum access assembly 166, septum access assembly 172 may include shutter assembly 174 and spring assembly 176. Once shutter assembly 172 moves to the "closed" position (e.g., which may prevent further access of septum 146 by the user), tab 178 may at least partially engage slot ISOa. Engagement between tab ! 78 and slot !80a may lock shutter assembly S 72 in the "closed" position to inhibit tampering and reopening of shutter assembly 172. Spring tab 182 of shutter assembly 172 may bias tab 178 into engagement with slot 180a.

However, in various embodiments, septum access assemblies may not be actuated linearly. For example and referring also K* FfCiS. 7Λ-7B, there is shown alternative embodiment septum access assembly 184 that includes shutter assembly i S6 fhat is configured to pivot about axis 188. When positioned in the open position (as shown in FlG. 7A), septum 146 may be accessible due to passage 190 (m shutter assembly 186) being aligned with passage 192 in e.g., a surface of disposable housing assembly 1 14. However, in a fashion similar to septum access assemblies 166, 172, upon penetrating septum 146 with filling syringe 160 (See FIG. 6B), shutter assembly S 86 may be displaced in a clockwise fashion, resulting in passage 190 (in shutter assembly 186) no longer being aligned with passage 192 in e.g., a surface of disposable housing assembly i 14, thus preventing access to septum 146.

Referring also to FIGS. 8A-88, an alternative-embodiment septum access assembly 194 is shown. In a fashion similar to that of septum access assemblies 166, 172, septum access assembly 194 includes shutter assembly 196 and spring assembly 198 that is configured io bias shutter assembly 196 in the direction of arrow 200. Filling assembly 202 may be used to fiii reservoir 1 1 8. Filling assembly 202 may include shutter displacement assembly 204 that may be configured to displace shutter assembly 196 in the direction of arrow 206, which in turn aligns passage 208 in shutter assembly 196 with septum 146 and passage 2 H) in septum access assembly 194, thus allowing filling syringe assembly 212 to penetrate septum 146 and fill reservoir 1 18. Infusion pump assembly 100 may include a sealing assembly ISO (FfG. 3) configured to provide a seal between reusable housing assembly 102 and disposable housing assembly S 14, For example, when reusable housing assembly 102 and disposable housing assembly 1 M are engaged by e.g. rotational screw-on engagement, twist-iock engagement or compression engagement, reusable housing assembly 102 and disposable housing assembly ! 14 may fit together smiggly, thus forming a seal. In some embodiments, it may be desirable for the seal to be more secure. Accordingly, sealing assembly J 50 may include an o-ring assembly (not shown). Alternatively, scaling assembly 150 may include an over molded seal assembly {not shown). The use of an o-ring assembly or an over molded sea! assembly may snake the seal more secure by providing a compressible rubber or plastic layer between reusable housing assembly 102 and disposable housing assembly 1 14 when engaged thus preventing penetration by outside fluids. In some instances, the o- ring assembly may prevent inadvertent disengagement. For example, sealing assembly 150 may be a watertight seal assembly and, thus, enable a user to wear infusion pump assembly 100 while swimming, bathing or exercising.

Referring also to FiG, 9, infusion pump assembly 100 may include an external infusion set 134 configured to deliver the infusible fluid to a user. External infusion set 134 may be in fluid communication with cavity 1 1 S, e.g. by way of the fluid path. External infusion set 134 may be disposed adjacent to infusion pump assembly 100. Alternatively, external infusion set 134 may be configured for application remote from infusion pump assembly 100, as discussed in greater detail below. External infusion set 134 may include a cannula assembly 136, which may include a needle or a disposable cannula I3S, and tubing assembly 140. Tubing assembly 140 may be in fluid communication with reservoir 1 18, for example, by way of the fluid path, and with cannula assembly 138 for example, either directly or by way of a cannula interlace 142.

External infusion set 134 may be a tethered infusion set, as discussed above regarding application remote from infusion pump assembly 100. For example, external infusion set 134 may be in fluid communication with infusion pump assembly 100 through tubing assembly 140, which may be of any length desired by the user (e.g., 3-18 inches). Though infusion pump assembly 100 may be worn on the skin of a user with {he use of adhesive patch 144, the length of tubing assembly 140 may enable the user to alternatively wear infusion pump assembly 100 in a pocket. This may be beneficial to users whose skin is easily irritated by application of adhesive patch 144, Similarly, wearing and/or securing infusion pump assembly 100 in a pocket may be preferable for users engaged in physical activity.

In addition to / as an alternative to adhesive patch 144, a hook and loop fastener system (e.g. such as hook and loop fastener systems offered by Velero USA inc. of Manchester, NH) may be utilized to allow for easy attachment ■^' removal of an infusion pump assembly (e.g., infusion purøp assembly 100} from the user. Accordingly, adhesive patch 144 may be attached to the skin of the user and may include an outward facing hook or ioop surface. Additionally, the lower surface of disposable housing assembly 114 may include a complementary hook or ioop surface. Depending upon the separation resistance of the particular type of hook and loop fastener system employed, it may be possible for the strength of the hook and loop connection to be stronger than the strength of the adhesive to skin connection. Accordingly, various hook and loop surface patterns may be utilized to regulate the strength of the hook and loop connection.

Referring also to FΪGS. 1 OA-IOE, five examples of such hook and loop surface patterns are shown. Assume for illustrative purposes that the entire lower surface of disposable housing assembly 1 14 is covered in a "loop" material. Accordingly, the strength of the hook and ioop connection may be regulated by varying the pattern (i.e., amount) of the "hook" material present on the surface of adhesive patch 144. Examples of such patterns may include but are not limited to: a singular outer circle 220 of "'hook'¹ material (as shown in FIG. 10A); a plurality of concentric circles 222, 224 of "hook" material (as shown in FlG. H)B); a plurality of radial spokes 226 of "hook" material (as shown in FlG. IOC); a plurality of radial spokes 228 of "hook" materia! in combination with a single outer circle 230 of "hook" materia! (as shown in FlCI 10D); and a plurality of radial spokes 232 of "hook" material in combination with a plurality of concentric circles 234, 236 of "hook" material (as shown in FICl 10E⁾.

Additionally and referring also to F(Cl 1 IA, in one exemplary embodiment of the above-described infusion pump assembly, infusion pump assembly 100" may be configured via a remote control assembly 300. In this particular embodiment, infusion pump assembly 100' may include telemetry circuitry (not shown) that allows for communication (e.g., wired or wireless) between infusion pump assembly 100' and e.g., remote control assembly 300, thus 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 may be capable of communicating with infusion pump assembly 100^') may include display assembly 302 and input assembly 304. Input assembly 3(H may include slider assembly 306 and switch assemblies 308. 310. In other embodiments, the input assembly may include a jog wheel a plurality of switch assemblies, or the like.

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 S 00\ Accordingly, the user may use remote cont.ro! assembly 300 to program / configure infusion pump assembly 100'. Some or all of the communication between remote control assembly 300 and infusion pump assembly 100^" may be encrypted to provide an enhanced level of security.

Communication between remote control assembly 300 and infusion pump assembly 100" may be accomplished utilizing a standardized comniυnieaiion protocol. Further. 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 DBKA Research & Development of Manchester, NM As discussed above, infusion pump assembly 100, 100' may include electrical control assembly 1 10 that may include one or more electrical components. For example, electrical control assembly 1 10 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, UW to communicate with remote control assembly 300. Further, 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 diagrammatic view of one example of such a system is shown in FIG. 1 IB,

Each of these electrical components may he manufactured from a different component provider and, therefore, may utilize native (i.e. unique) communication commands. Accordingly, through the use of a standardized communication protocol, efficient communication between such disparate components may be accomplished. PCGP may be a flexible extendable software module that may he used on the processors within infusion pump assembly 100, KKF and remote control assembly 300 to build and route packets, PCGP may abstract the various interfaces and may provide a unified application programming interface (API) to the various applications being executed on each processor. PCGP may also provide an adaptable interlace to the various drivers. For illustrative purposes only. PCGP may have the conceptual structure illustrated in PSG. I l C for any given processor,

PCGP may ensure data integrity by utilizing cyclic redundancy checks (CRCs). S¹CGP may also provide guaranteed delivers- status. For example, all new messages should have a reply. If such a reply isn't sent back in time, the message may time out and FCGP may generate a negative acknowledge reply message for the application (i.e., a NACK). Accordingly, the message-reply protocol may Set the application know whether the application should retry sending a message.

PCGP may be designed to work in an embedded environment with or without an operating system by using a semaphore to protect shared data such that some calls can be re-entrant and run on a multiple threads. One illus.irat.ive example of such an implementation is shown in FICJ. ! I D. PCGP may operate the same way in both environments, but there may be versions of the call for specific processor types (e.g., the ARM 9 / C)S version) So while the functionality may be the same, there may be an operating system abstraction layer with slightly different calls tailored for e.g., the ARM 9 Nucleus OS environment.

Referring also to FlG. 1 1 E. PCCJF may:

* allow multiple Send / Reply calls to occur (on PiIoCs ARM 9 on multiple tasks re-entrant); * have multiple drivers running asynehronously for RX and TX on different interfaces; and

• provide packet ordering for send / receive, and deterministic timeout on. message send.

5 Each software object may ask the buffer manager for the next butler to use, and may then give that buffer to another object. Buffers may pass from one exclusive owner to another autonørøicly, and queues may occur automatically by ordering buffers by sequence number. When a buffer is no longer in use, the buffer may be recycled (e.g., object attempts to give the buffer to itself, or frees it for the buffer manager to re-allocate later). Accordingly, data generally doesn't need to be copied, and routing simply writes over the buffer ownership byte.

Such an implementation of PCCiP may provide various benefits, examples of which may include but are not limited to:

• drivers may exchange ownership of message data by writing over one byte f i.e., the buffer ownership byte K

• there may be no need for multiple exclusions except for re-entrant calls, as a mutual exclusion may be needed only when a single buffer owner could simultaneously want to use a buffer or get a new sequence number;

* drivers may use ISR / push / pull and polled data models, as there are a set of calls provided to push / pull data out of the buffer management system from the drivers;

* drivers may not do much work beyond TX and RX₁ as drivers may not copy, CRC or check anything but the destination byte and CRC and other checks may he done off of the ISR hot path later;

* a small code / variable foot print may be utilized; hot path code may be small and overhead may be low.

As shown in FIG. 1 1

when a message needs to be sent, the PCCiP may build the packet quickly and may insert it into the buffer management system. Once in the buffer management system, a call to "packetPracessor" may apply protocol rules and may give the messages to the drivers / application. 0 To send a new message or send a reply, FCGP may: • check the call arguments to e.g., make sure the packet length is legal, destination Is ok, etc.;

• avoid trying to send a message across a link that Ls down unless the down link is the radio node, which may allow PCGP to be used by the radio processors to establish a link, pair, etc. and may notify the application when PCGP is trying to talk across a link that is not functional < instead of timing out };

Referring also to RGS. S IG-I ! M. PCXJP may work by doing all of the main work on one thread to avoid mutual exclusions, and to avoid doing considerable work on the send / reply or driver calls. The "packetProeessor" call may have to apply protocol rules to replies, new sent messages, and received messages. Reply messages may simply get routed, but new messages and received messages may have rules for routing the messages, hi each case, the software may loop while a message of the right type is available to apply protocol rules until it eatmot process the packets.

Sending a new message may conform to the following rules:

• only two messages may be allowed "in-flight" on the network; and

Receiving a message may conform to the following rules:

• responses that match may clear out the "in-flighr information slot so a new- packet can be sent;

• the call back function owns the buffer and may reference the buffer and the buffer's payload by the payload address, wherein the message may be processed later;

• applications may poll the FCGP system for received messages; and * applications may use the call back to set an event and then poll for received messages.

The communication system may have a limited number of buffers. When PCGP runs out of buffers, drivers may stop receiving new packets and the application may be told that the application cannot send new packets. To avoid this and maintain optimal performance. the application may try to perform one or more procedures, examples of which may include but are not limited to:

a) The- application should keep FCGP up to date with radio status: Specifically, if the link goes down and PCGP doesn't know, PCGP may accept and queue new- messages to send (or not timeout messages optimally), which may jam the send queue and delay the application from using the link optimally.

b) The application should call "decrement timeouts" regularly: Optimally, ever>- 20-100 milliseconds unless the processor is asleep, in general, a message moves fast (milliseconds) slow {seconds} or not at all. Timeouts are an attempt to remove 'in-fjighf messages that should be dropped to free up buffers and bandwidth. Doing this less often may delay when a new message gets sent, or when the application can queue a new message,

c) The application should ask PCGP if it has work to do that is pending before going to sleep: If PCGP has nothing to do, driver activity may wake up the system and thus PCXJP, and then PCCJP won't need a call to "packet Processor" or "decrement timeouts" until new packets enter the system. Failure to do this may cause messages that could have been sent / forwarded / received successfully to be dropped due to a timeout, condition.

d) The application should not hold onto received messages indefinitely: The message system relies on prompt replies, if the application is sharing PCGP buffers, then holding onto a message means holding onto a PCTiP buffer. The receiving node doesn't know if the sending node has timeout configured for slow or fast radio. This means when a node receives a message it should assume the network's fast timeout speed.

e) The application should call the "packetProcessor" often: The call may cause new messages queued by the application to get sent and may handle receipt of new messages. The call may also cause buffers to re-allocate and calling it infrequently may delay message traffic.

As shown in FICi. 1 i I, at some point the RX driver may be asked to receive a message from the other side of the interface. To ensure a message does not get dropped, the RX driver may ask the buffer manager if there is an available buffer for storing a new message. The driver may then ask for a buffer pointer and may start filling the buffer with received data. When a complete message is received, the RX driver may calf a function to route the packet. The route function may examine the destination byte in the packet header and may change the owner to either the other driver, or the application, or may detect that the packet is bad and may drop the packet by freeing the buffer.

■? Rece i ve re^ϋe^t uim: 8 i -0 , * ρ; i t ( B?: i dqt- : : 03;)k<κ:^;:: LveFi OwCocs k s oi ( ) ) p ■■ Br idge : : -V=XtBa ^ i erPX ( ) ; whi l e (not dor;4 j i ρ [ i l ~ the next byre; i Bridqe : : route ''p s ; »

A driver may perform a TX by asking the buffer manager for the pointer to the next buffer to send. The TX driver may then ask the other side of the interlace ifit can accept a packet. If the other side denies the packet, the TX driver may do nothing to the buffer, as its status has not changed. Otherwise, the driver may send the packet and may recycle / free the buffer. An example of code that performs such a function is as follows: ι!i n.t.fs ⁺p -• Br kkK? : : next.Bυ f f $>rTX ( ) ;

B?: :i d^;:;e ; : ?: ecy^;::j.^;;_: fp) ;

\

To avoid forwarding packets that are past the maximum message system timeout time, asking for the next Buffer may call the BulTerManager::fϊrst(uiirt8 owner) function that may scan for buffers to free, Accordingly, full TX buffers with no hope of making a timeout may be freed on the thread that owns the buffer. A bridge that is doing TX (i.e. , while looking for the next TX buffer) may free all of the TX buffers ihat are expired before receiving the next TX buffer for processing.

As shown in. FIG. i U- I S L, during the buffer allocation process, buffers marked tree may be transferred to the drivers to receive new packets, or to PCGP to receive new payloads for TX. Allocation from "free" may be done by the "packetProcessor" function. The number of sends and receives between ''packetProcessof ' calls may dictate how many LTJ>river_RX, GTJDriver_^RX and PCGPJ-reε buffers need to be allocated. LTJDriver may represent drivers thai handle addresses that are less than the node address. GT Driver may represent drivers that handle addresses thai are greater than the node address. When a driver receives a packet, the driver may put the data into an RX buffer that gets handed to the router. The roister may then reassign the butler to PCGP__Receive or to the other driver^'s TX (not shown). If the buffer contains obviously invalid data, the buffer may transition to free. After a router marks a buffer for TX, the driver may discover the buffer is TX and may send the message. After sending the message, the buffer may immediately become an RX buffer if the driver was low in RX buffers, or the buffer may be freed for re-allocation.

During the "packet Processor" call, PCGP may process al! buffers that the router marked as PCGP Receive, At this point, data may be acted upon, so the CRC and other data items may be checked. If the data is corrupted, a statistic may be incremented and the buffer may be freed. Otherwise, the buffer may be marked as owned by the application. Buffers marked as owned by the application may be either recycled for the use of PCGP or freed for real location by the buffer manager.

When the application wants to send a new message, it may be done in a re-entrant friendly / mutual exclusion manner. If the buffer may be allocated, PCXiP may mark the buffer as busy. Once marked busy, no other thread calling the send or reply functions may grab this buffer, as it is owned by this Junction call's invocation. The remainder of the process of error cheeking 'and building the message may be done outside the isolated race condition mutual exclusion guarded code. The buffer may either transition to free or may become a valid filled CRC-cheeked. buffer and passed to the router. These buffers may not be routed immediately and may be queued so that messages can be sent later (assuming that protocol rules allow). Reply messages may be marked differently than new send messages because reply messages may be routed with a higher priority than regular send messages and reply messages may have no rules limiting how many / when they can be sent. PCGP was designed to work with flow control and How control may negotiate the transfer of messages from one node to another node so that a buffer is never dropped because the other side of an interface lacks a buffer (which may cause back pressure on the sending node).

Flow control may be apart of the shared buffer format. The first two bytes may be reserved for the driver so that the driver never needs to shift the packet bytes. Two bytes may be used so that one byte is the DMA length -- 1, and the second byte is to control the flow of messages. These same two bytes may be synchronizing bytes if a PCGP message is transmitted over RS232. When a packet is "iπ~fUghf , the packet may be in the process of being sent by a driver on the way to us destination, being processed by the destination, or being sent hack as a response.

Typical delays are as follows;

Accordingly, messages tend Io complete the round trip either; quickly (e.g., <50 røs); slowly (e.g., one or more seconds): or not at ail.

FCGP may use two different times (set at initialization} for all timeouts, one for when the RF link is in fast heartbeat mode, and another for when the RF link is in slow mode. If a message is in-flight and the link status changes from last to slow, the timeout may be adjusted a ' nd the difference between fast and slow may be added to the time-to-iive counter for the packet, No additional transitions back and forth may affect the time-to-ϊive time for the message.

There is a second timeout that may be twice as long as the slow timeout that is used to monitor buffer allocation inside PtXiP. Accordingly, if a message is "stuck" inside a driver and hasn^'t been sent due to e.g., flow control or hardware damage, the buffer may be freed by the buffer manager, resulting in the buffer being dropped. For a "new" message, this may mean that the packet already timed out and the application was already given a reply saying the message wasn't delivered, resulting in the buffer being freed. Since the driver polls the buffer manager for buffers that need to be sent, the builer is freed up so that a message that could be sent is handed to ihe driver the next time that it unblocks. For a reply message, the reply may simply get dropped and the sending node may time out.

The PCGF messaging system may pass messages that contain header information and payioad. Outside of PCGF. the header may be a set of data items in a call signature. However, internal to 3^'-¹CGP, there may be a consistent, driver friendly byte layout. Drivers may insert bytes either into the PCGP packet or before the PCGP packet such;

• DE, CA: Synch bytes for use with RS232, nominal value of OxDE, OxCA or 0x5 A, 0xA5. • LO; Driver DMA length byte, equals amount driver is pushing in this DMA transfer, which is the total size, not including the size byte or synch bytes.

• Cmd: Driver command and control byte used for flow control.

• LP: PCGF packet length, always the total header H- pay load size in bytes -f CRC size. LD - LP M .

• DsI: Destination address.

• Src; Source address

• Cmd: Command byte.

• Scd; Sub command byte * AT: Application Tag is defined by the application and has no significance to

• SeqNum: thirty-two bit sequence number is incremented by PCGP for a new message sent, guarantees the number will not wrap, acts as a token, endianess Isn't relevant,

• CRC 16: A sixteen bit CRC of the PCG P header and payload.

An example of a message with no payload, cmd^:::l, subcmd~2 is as follows;

OxDE, ϋ.-:CA, OKC, 0X5, 0X14, ], .?, 0, 0, 0, 0, ^xI, cfV^iqh, CECiOW.

0Λ0D» and, OxC, OxS, 0x14, 1, 2, 0, 0, G, 0, OxI, cKch.wh,

There may be several advantages to this methodology, examples of which may include but are not limited to: • Most of our hardware DMA engines may use ihe first byte to define how many additional bytes to move, so in this methodology, drivers and PCGP may share buffers,

♦ A byte may be provided right after the DMA length to pass flow control information between drivers. • Driver length and "Cmd" byte may be outside the CRC region so they may be altered by the driver, may be owned by the driver transport mechanism, and the driver may guard for invalid lengths.

♦ There may he a separate PGCP packet length byte thai is CRC protected. Accordingly, the application may trust the that payload length is correct. • The endianπess of the sequence number may not be relevant, as it is just a byte pattern that, may be matched that happens to also be a thirty-two bit integer.

♦ The application, driver and FCGP may share buffers and may release them by pointer. PC(JP may not be an event driven software design, but may be used in event driven architectures by how the sub-classes are written. Data may be exchanged between the classes conceptually (as shown in FIG. 1 1 IVI-I I N).

The following summarizes some exemplary events:

The following illustrative example shows how the PCGP event model may work with Nucleus to wakeup the PCGP task after every message send, reply, or decTirneout that generated a N AC K : c L:: sis PcαpOS ' publ ic Pcqp v j. r. tλxcx 1 vo i d s.chϊκk3 i δP;ϊc ket PXΌCK- SSOΪ (vo i.d j i OS EventOrp Set ( g RCVEvGrps ( EVG RK^' TASK i . pEvglia ndie ,

RfPadioTxEven;:, OS EV OR MO CL.EΛR) ;

The following is a pseudo code driver that is event based, illustrating how driver events work. The Driver subclasses Bridge and overrides hasMcssagesToSend and flowControiTurnedOrYto schedule ihe TX and RX functions to run if they aren't, already running. lass 3PΪ Drive K : public Bridge vi n;ua L void hasHessagesToSend { ) Triages: XSR(TX ΪSR, thisi;

'irtual void f lowCoritrolTurnodOf f { } T?:igqftr LSPfRX iSP_r ;:h.is};

static void TX___Rot:ryTimer [ } Trio-αe;: ISR(TX ΪSR, this);

static void TX IGR (Bridge ^'Ab5 do

{ iiintci *p -- b">nex':Buf i:e^;:?X {) ; if (p ~~

bisak; 11: il>~> biii: i:e;;Mans>'36;:->buf [ϊfjϊTλfsaάOuu (p) "-"-liaise) if (Oth-^SicieSPF. FlowContr.ol {) -— f.a^'isκ) f

Trigger TX FetryT.hr^r in 20 mssc .

ssπd{o) ; } free (p) ;

} while π:rusθ ; SnafoielSR;; {} ;

static void RXJ-SK (Bridge "b) i

Ui88b:U_:lSSsi) ; do { ;

■'^■I lie (i\ot. done :f^;;;ce;. virigj p LL s-i-j ----- get.Ch« O ; ->royt<;; (p) ? ;U: (true) ;

E csab elSRs; ( ) ;

File following statistics may be supported by PCXJP:

♦ Number of packets sent;

♦ N umber of packets received;

• CRC errors; ♦ Timeouts: and

• Buffer unavai Sable (ran out of buffers)

PCXiP may be designed to run in multiple processing environments. Most parameters may be run time configured because it facilitates testing, and any run lime One tuning for performance. Other parameters may be compile time e.g., anything thai alters memory allocation must be done statically at compile time.

The following may be compile time configuration #defines that may vary where PCGF is implemented:

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

♦ # RX driver buffers: may be tuned to how many buffers would be good for that processor / traffic flow, etc. • ≠ PCGP RX buffers; may be limed to how many buffers would be good for {.hat processor / traffic flow, etc,

• Total # of buffers: may be tuned to how many boilers should be at thai processor. The CRC may be used to ensure data integrity. If a CRC is invalid, it may not be delivered to the application and the CRC error may be tracked. The message may eventual (y timeout and may be retried by the originator.

DBKA may provide a reference way of interfacing PCCfP into the Nucleus OS system on the ARM 9 (as shown in FIG. 1 10}. As shown in FIG. 1 1 P. the pcgpOS.cpp file may instantiate a PtX)F node instance

(Pegp, a Bridge, etc.) and may provide through pcgpOS.h a T^" linkable set of function calls thai provide a ⁴C language interlace to the C>+ code. This may simplify the 'C code as the objects acted upon arc implicit.

• Race conditions may not be permitted.

• May support CC2510 operating at OMA (fast) SPI clock rates.

SPl flow control may prevent data from being sent if the receiving side does not currently have a.n empty butter to place the packet. This may be accomplished by asking for permission to send and waiting for a response indicating that you have been cleared to do so. There may also be a way to tell the other side that there are currently no free butters and the transfer should be attempted at a later time.

All transmission may begin with a length byte that indicates the number of bytes to be sent, not including the length byte itself. Following the length may be a single byte indicating the command being sent. The actual transmission of a packet may be the length of packet plus one for the command byte, followed by the command byte for a message appended and finally the packet itself.

In addition to the command bytes that will be sent, an additional hardware Hue called the FlowControl line may be added to the traditional four SPI signals. The purpose of this line is to allow the protocol to ran as quickly as possible without a need for preset delays. It also allows the slave processor to tel! the master processor that it has a packet waiting to be sent, thus eliminating the need for the master processor to poll the slave processor for status.

The following exemplary command values may be used:

Commands to be sent- by the master processor;

Commands to foe sent by the slave processor;

As illustrated in FICi. 1 1 Q, when the slave processor has a packet Io send to the master processor, the slave processor may notify the master processor (by asserting the FiowContrαl line) that it has a pending packet that is waiting to be sent. Doing so may result in an IRQ on the master processor at which time the master processor may decide when to go retrieve the message from the slave processor. Retrieving the packet may be delayed at the discretion of the master processor, and the master processor may even decide to attempt to send a packet to the slave processor before retrieving from the slave processor.

The master processor may begin the retrieval by sending the slave processor M CTS commands; this shall be repeated until the slave processor responds by sending the SJMSG_A PPEN DED command along with the packet itself. The FtowControl line may be cleared after the packet has been sent. If a M CTS command is received by the slave processor when one is not expected, the SVIJTTS command may be ignored. As illustrated in FIG. I IR₁ when the master processor lias a packet to send to the slave processor, the master processor may initiate the transfer by sending a MJRTS command. Upon receiving the M RTS command, if the slave processor currently has a send packet pending, the slave processor will Sower the FlowConiro! line so that it may be re-used as a Cleared To Send signal. Ttie slave processor may then tell the master processor that it is in the process of preparing the SPΪ DMA to receive the packet, during which time the master processor may stop clocking bytes onto the bus and may allow the slave processor to finish preparing for the receive.

The slave processor may then indicate it is ready to receive the full packet by raising the FlowControi line (which is now used as the CTS signal). Upon receiving the CTS signal the master processor may proceed to send the M_MSG_y\PPENDED command along with the packet itself.

After the completion of the transfer, the slave processor may lower the FlowControi line. If a packet was pending at the start of the transfer, or a send occurred on the slave processor when the packet was being received, the slave processor may reassert the FlowControi line now indicating that it has a pending packet.

Referring again to FlG. 1 I A, infusion pump assembly 100, 100' may include switch assembly 318 coupled to electrical control assembly 1 10 (FIG, 3} that may allow a user (not shown) to perform at least one, and in some embodiments, a plurality of tasks. One illustrative example of such a task is the administration of a bolus dose of the infusible fluid (e.g._v insulin) without the use of a display assembly. Remote control assembly 300 may allow the user to enable / disable / configure infusion pump assembly 100, 100" to administer the bolus dose of insulin.

Referring also to FiG. 12A, slider assembly 306 may be configured, at least in part, to enable the user to manipulate the menu-based information rendered on display assembly 302. An example of slider assembly 306 may include a eapacitive slider assembly, which may be implemented using a CY8C21434-24LFXI PSOC offered by Cypress Semiconductor of San Jose, California, the design an operation of which are described within the "CSD User Module" published by Cypress Semiconductor, For example, via slider assembly 306, the user may slide their finger in the direction of arrow 314, resulting in the highlighted portion of the information included within main menu 350 (shown in FIG. 12A) rendered on display assembly 302 scrolling upward. Alternatively, the user may slide their finger in the direction of arrow 316, resulting in the highlighted portion of the information included within main menu 350 rendered on display assembly 302 scrolling downward.

Slider assembly 306 may be configured so thai the rate at which e.g. the highlighted portion of main menu 350 scrolls '"upward^1* or "downward" varies depending upon the displacement of the finger of the user with respect Io point of origin 320. Therefore, if the user wishes lo quickly scroll ''upward", the user may position their finger near the lop of slider assembly 306. Likewise, if the user wishes to quickly scroll "downward", the user may position their finger near the bottom of slider assembly 306. Additionally, if the user wishes lo slowly seroH "upward", the user may position their linger slightly "upward^"' with respect to point of origin 320 Further, if the user wishes to slowly scroll "downward", the user may position their linger slightly "downward" with respect to point of origin 320. Once the appropriate menu item is highlighted, the user may select the highlighted menu item via one or more switch assemblies 308, 310,

Referring also to FΪGS 12B-12F, assume for illustrative purposes that infusion pump assembly 100, 100' is an insulin pump and the user wishes to configure infusion pump assembly 100, 100^" so that when switch assembly 3 S 8 is depressed by the user, a 0.20 unit bolus dose of insulin is administered. Accordingly, the user may use slider assembly 306 to highlight "Bolus" within main menu 350 rendered 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 then render submenu 352 on display assembly 302 {as shown in FiG. 12B).

The user may then use slider assembly 306 to highlight "Manual Bolus^*' within submenu 352, which may be selected using switch assembly 3CKS. Processing logic (not shown) within remote control assembly 300 may then render submenu 354 on display assembly 302 {as shown in RG. 12C).

The user may then use slider assembly 306 to highlight "Bolus: 0.0 Units'" within submenu 354, which may be selected using switch assembly 308, Processing logic (not shown) within remote control assembly 300 may then render submenu 356 on display assembly 302 {as shown in FIG. 12D). The user may then use slider assembly 306 to adjust the "Bolus^"1 insulin amount to

"0.20 units^'", which may be selected using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then render submenu 358 on display assembly 302 {as shown in PIG. 12E). The user 14 may then use slider assembly 306 to Mghlighi '"Confirm", which may be selected using switch assembly 308. Processing logic (not shown) within remote control assembly 300 may then generate the appropriate signals that may be sent to the above- described telemetry circuitry (not shown) included with in remote control assembly 300. The telemetry circuitry (not shown} included within the remote control assembly may then transmit, via wireless communication channel 312 established between remote control assembly 300 and infusion pump assembly 100', the appropriate configuration commands to configure infusion pump assembly 100' so that whenever switch assembly 318 is depressed by the user, a 0.20 unit bolus dose of insulin is administered. Once the appropriate commands are successfully transmitted, processing logic (not shown) within remote control assembly 300 may once again render submenu 350 on display assembly 302 (as shown in FiG. 12F).

Specifically and once programmed via remote control assembly 300, the user may depress switch assembly 318 of infusion pump assembly 100' to administer the above- described 0,20 unit bolus dose of insulin. Via the above-described fnemimg system included within remote control assembly 300, the user may define a quantity of insulin to ^"be administered each time that the user depresses switch assembly 31 S. While this particular example specifies that a single depression of switch assembly 3 I S is equivalent to 0.20 units of insulin, this is for illustrative purposes only and is not intended to be a limitation of this disclosure, as other values (e.g. 1.00 units of insulin per depression) are equally applicable. Assume for illustrative purposes that the user wishes to administer a 2.00 unit bolus dose of insulin. To activate the abovc-dcscribc bolus dose administration system, the user may be required 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 thai infusion pump assembly 100, !00^v is ready to administer a bolus does of insulin via switch assembly 318. Accordingly, the user may depress switch assembly 318 ten times (i.e., 2,00 units is ten 0.20 unit doses). After each time that switch assembly 318 is depressed, infusion pump assembly ] 00, 100' may provide on audible response to the user via an internal speaker / sound generation device (not shown). Accordingly, the user may depress switch assembly 31 S the first time and infusion pump assembly 100, 100' may generate a confirmation beep in response, thus indicating to the user that infusion pump assembly 100, 100' received the command for (in this particular example) 0.20 units of insulin. As the desired bolus dose is 2,00 units of .insulin, the user may repeat this procedure nine more times in order to effectuate a bolus dose of 2.00 units, wherein infusion pump assembly 100, 100' generates a confirmation beep after each depression of switch assembly 318.

While in this particular example, infusion pump assemblies I UO, IiW are described as providing one beep after each time the user depresses switch assembly 3 I 8, this is for illustrative purposes only and is not intended to be a limitation of this disclosure. Specifically, infusion pump assembly 100, U)(J' may be configured to provide a single beep for each defined quantity of insulin. As discussed above, a single depression of switch assembly 318 may be equivalent to 0.20 units of insulin. Accordingly, infusion pump assembly S 00, 100' may be configured to provide a single beep for each 0.10 units of insulin. Accordingly, if infusion pump assembly 100, 100' is configured such that a single depression of switch assembly 318 is equivalent to 0.20 units of insulin, each time switch assembly 318 is depressed, infusion pump assembly i 00, 100" may provide the user with two beeps (i.e. one for each 0, 10 units of insulin). Once the user has depressed switch assembly 318 on infusion pump assembly 100^" a total often times, the user may simply wait for infusion pump assembly 100, 100' to acknowledge receipt of the instructions to administer a 2.00 unit bolus dose of insulin {as opposed to the confirmation beep received at each depression of switch assembly 3 i 8). Once a defined period of time (e.g., two seconds) passes, infusion pump assembly 100. 100" may provide an audible confirmation to the user concerning the quantity of units to be administered via the bolus insulin dose that the user just requested. For example, as fin this example) infusion pump assembly 100, 100' was programmed by the user so that a single depression of switch assembly 318 is equivalent to 0.20 units of insulin, infusion pump assembly 100, ! 00' may beep ten times {i.e., 2.00 units is ten 0.20 unit doses). When providing feedback to the user concerning die quantity of units to be administered via the bolus insulin dose, infusion pump assembly 100, 100' may provide a rnulti frequency audible confirmation. For example and continuing with the above-slated example in which ten beeps are to be provided to the user, infusion pump assembly 100. 100' may group the beeps into groups of five (to facilitate easier counting by the user) and the beeps within each group of five may be rendered by infusion pump assembly 100, 100' so that each subsequent beep has a higher frequency than the preceding beep (in a manner similar to a musical scale). Accordingly and continuing with the above-stated example, infusion pump assembly 100, 100' may render a 1 ,000 Hz beep, followed by an IJOO Ii?. beep, followed by a 1,200 1 Iz beep, followed by a 1,300 Ui beep, IbI lowed by a 1,400 Sk beep (thus completing a group of live beeps), followed by a short pause, and then a 1 ,000 Hz beep, followed by an 1 ,100 Hz beep, followed by a 1 ,200 Hz beep- followed by a 1 ,300 Hz beep, followed by a 1,400 Hz beep (thus completing the second group of five beeps). According to various additional / alternative embodiments the roulti frequency audible confirmation may utilize various numbers of tones incrementing in frequency. For example, an embodiment may utilize twenty different tones incrementing in frequency. However, the number of tones should not be construed as a limitation of the present disclosure as number of tones may vary according to design criteria and user need, Once infusion pump assembly 100, 100 ' completes the rendering of the multiirequeney audible confirmation (i.e. the ten beeps described above), the user may, within a defined period of time (e.g. two seconds}, depress switch assembly 318 to provide a confirmation signal to infusion pump assembly 100, 100\ indicating that the mυiti frequency audible confirmation was accurate and indicative of the size of the bolus dose of insulin to be administered {i.e. 2.00 units K Upon receiving this confirmation signal, infusion pump assembly 100, 100' may render a "confirmation received^"1 audible tone and effectuate the delivery of (in this particular example) the 2.00 unit bolus dose of insulin, in the event that infusion pump assembly 100, L00' fails to receive the above-described confirmation signal infusion pump assembly 100, 100' may render a "confirmation failed" audible tone and will not effectuate the delivery of the bolus dose of insulin. Accordingly, if the multiSrequency audible confirmation was not accurate / indicative of the si/.e of the bolus dose of insulin to be administered, the user may simply not provide the above- described confirmation signal, thereby canceling the delivery of the bolus dose of insulin. As discussed above, in one exemplary embodiment of the above-described infusion pump assembly, infusion pump assembly 100' may be used to communicate with a remote control assembly 300, When such a remote control assembly 300 is utilized, infusion pump assembly 100^' and remote control assembly 300 may routinely contact each other to ensure thai the two devices are still in communication with each other. For example, infusion pump assembly K⁾O^' may "ping" remote control assembly 300 to ensure that remote control assembly 300 is present and active. Further, remote control assembly 300 may "ping" infusion pump assembly 100^* to ensure that infusion pump assembly 100' is still present and active. In the event thai one of infusion pump assembly 100^" and remote control assembly 300 fails to establish communication with the other assembly, the assembly that is unable to establish communication may sound a "separation" alarm. For example, assume that remote control assembly 300 is left in the car of the user, while infusion pump assembly 100' is in ihe pocket of the user. Accordingly and after a defined period of time, infusion pump assembly IQ(T may begin sounding the "separation" alarm, indicating that communication with remote control assembly 300 cannot be established. Using switch assembly 318, the user may acknowledge / silence this "separation" alarm.

As the user may define and administer a bolus insulin dose via switch assembly 318 of infusion pump assembly KW while remote control assembly 300 is not in communication with infusion pump assembly !0θ\ infusion pump assembly 100^' may store information concerning the administered bolus insulin dose within a log file (not shown) stored within infusion pump assembly 100\ This log file (not shown) may be stored within nonvolatile memory (not shown) included within infusion pump assembly 100'. Upon communication being reestablished between infusion pump assembly 100' and remote control assembly 300, infusion pump assembly 100' may provide the information concerning the administered bolus insulin dose stored within the log file (not shown) of infusion pump assembly 100' to remote control assembly 300.

Further, if the user anticipates separating remote control assembly 300 from infusion pump assembly 100^", the user {via the above-described menuing system) may configure infusion pump assembly 100' and remote control assembly 300 to be in '"separation^"' mode, thus eliminating the occurrence of the above-described "separation" alarms. However, the devices may continue to "ping^"* each other so that when they come back, into communication with each other, infusion pump assembly 100' and remote control assembly 300 may automatically exit "separation" mode.

Further, if the user anticipates traveling in an airplane, the user (via the above- described menuing 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 suspend 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. Switch assembly 318 may be used to perform additional functions, such as: checking the batten' life of reusable housing assembly 102; pairing reusable housing assembly 102 with remote control assembly 300; and aborting tiie administration of a bolus does of infusible fluid. Checking Battery Life; Reusable housing assembly 102 may include a rechargeable battery assembly that may be capable of powering infusion pump assembly 100, W(T for approximately three days (when fully charged). Such a rechargeable battery assembly may have a usable life of a predetermined number of usable hours, for example, or years, or other predetermined length of usage. However, the predetermined life mtxy depend on many factors, including but not limited to, one or more of the following: climate, daily usage, and number of recharges. Whenever reusable housing assembly 102 is disconnected from disposable housing assembly 1 14. infusion pump assembly 100, 100' may perform a battery cheek on the above-described rechargeable battery assembly whenever switch assembly 318 is depressed for a defined period of time f e .g. in excess of two seconds). In the event that the above-described rechargeable battery assembly is determined to be charged above a desired threshold, infusion pump assembly 100, 100' may render a "battery- pass" tone. Alternatively, in the event that the above-described rechargeable battery- assembly is determined to be charged below a desired threshold, infusion pump assembly 100, 100' may render a "battery fail" 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 1 14.

Pairing: As discussed above and in one exemplary embodiment of the above- described infusion pump assembly, infusion pump assembly 100' may be used to communicate with remote control assembly 300. In order to effectuate communication between infusion pump assembly 100' and remote control assembly 300, a paring process may be performed. During such a pairing process, one or more infusion pump assemblies (e.g. infusion pump assembly HXO 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' K Specifically, the serial numbers of the infusion pump assemblies (e.g. infusion pump assembly 100^') may be recorded within a pairing HIe (not shown) included within remote control assembly 300 and the serial number of remote control assembly 300 may be recorded within a pairing file (not shown) included within the infusion pump assemblies (e.g. infusion pump assembly 100^'}.

According to an embodiment, in order to effectuate such a pairing procedure, the user may simultaneously hold down one or more switch assemblies on both remote control assembly 300 and infusion pump assembly 100\ For example, the user may simultaneously hold down switch assembly 3 I 0 Included within remote control assembly 300 and switch assembly 318 included within infusion pump assembly 100' for a defined period exceeding e.g. fn^:o seconds. Once this defined period is readied, one or more of remote control assembly 300 and infusion pump assembly 100^* may generate an audible signal indicating that the above-described pairing procedure has been effectuated.

According to another embodiment, prior to performing the pairing process, the user may uncouple reusable housing assembly 102 from disposable housing assembly S 14, By- requiring this initial step, further assurance is provided that an infusion pump assembly being worn by a user may not be surreptitiously paired with a remote control assembly, Once uncoupled, 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 above-described menuing system in combination with e.g., switch assembly 310. The user may be prompted on display assembly 302 of remote control assembly 300 to depress and hold switch assembly 318 on infusion pump assembly 100'. Additionally, remote control assembly 304 may switch to a low power mode to e.g., avoid trying to pair with distant infusion pump assemblies. The user may ihen depress and hold switch assembly 318 on infusion pump assembly 100' so that infusion pump assembly 100' enters a receive mode and waits for a pairing command from remote control assembly 300. Remote control assembly 300 may then transmit a pairing request, to infusion pump assembly 100', which may be acknowledged by infusion pump assembly 100', Infusion pump assembly 100' may perform a security check on the pairing request received from remote control assembly 300 and (if the security check passes) infusion pump assembly 100' may activate a pump pairing signal {i.e., enter active pairing mode). Remote control assembly 300 may perform a security cheek on the acknowledgment received from infusion pu mp assembly 100'.

The acknowledgment received from infusion pump assembly 100' may define the serial number of infusion pump assembly SOO' and remote control assembly 300 may display that serial number on display assembly 302 of remote control assembly 300, The user may be asked if they wish to pair with the pump found. 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 depress and hold switch assembly 318 on infusion pump assembly 100'. The user may then depress and hold switch assembly 318 on infusion pump assembly UW and depress and hold e.g. switch assembly 310 on remote control assembly 300.

Remote control assembly 300 may confirm that remote switch assembly 3 H⁾ was 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 the integrity of same. If the integrity of the confirmation received is not verified, the pairing process is aborted. If the integrity of the confirmation received is verified, any existing remote pair configuration file is overwritten to reflect newly-paired remote control assembly 300, the pump pairing completed signal is activated, and the pairing process is completed.

Additionally, infusion pump assembly 100^* may confirm that switch assembly 318 was 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 confirm the integrity of same. If the integrity of the eonlirmation received is not verified, the pairing process is aborted. If the integrity of the confirmation received is verified, a pair list HIe within remote control assembly 300 may be modified to add infusion pump assembly 100'. Typically, remote control assembly 300 may be capable of pairing with multiple infusion pump assemblies, while infusion pump assembly 100" may be capable of only pairing with a single remote control assembly. The pairing completed signal may be activated and the pairing process may be completed.

When the pairing process is completed, one or more of remote control assembly 300 and infusion pump assembly 100" may generate an audible signal indicating that the above- described pairing procedure has been successfully effectuated, Aborting Butus Dose: in the event that the user wishes to cancel a bolus dose of e.g. insulin being, administered by infusion pump assembly 10O\ the user may depress switch assembly 318 (e.g., shown in FIGS. I & 2} for a defined period exceeding e.g. five seconds. Once this defined period is reached, infusion pump assembly KK)' may render an audible signal indicating that the above-described cancellation procedure has been effectuated. While switch assembly 3 S 8 is shown as being positioned on the top of infusion pump assembly 100, 100^*. this is for illustrative purposes only and is not intended to be a Limitation of this disclosure, as other configurations are possible. For example, switch assembly 318 may be positioned about the periphery of infusion pump assembly KKX 100'. Referring also to FIGS. 1 3-15, there is shown an alternative-embodiment infusion pump assembly 400. As with pump assembly IC)O, 100', infusion pump assembly 400 may include reusable housing assembly 402 and disposable housing assembly 404.

In a fashion similar to reusable housing assembly 102, reusable housing assembly 402 may include a mechanical control assembly (that includes at least one pump assembly and at least one valve assembly). Reusable housing assembly 402 may also include an electrical control assembly that is configured to provide control signals to the mechanical control assembly and effectuate the delivery of an infusible fluid to a user. The valve assembly may be configured to control the flow of the infusible fiuid through a fluid path and the pump assembly may be configured to pump the infusible fluid from the fluid path to the user

In a fashion similar to disposable housing assembly 1 14, disposable housing assembly 404 may be configured for a single use or for use for a specified period of time, e.g., e.g., three days or any other amount of time. Disposable housing assembly 404 may be configured such that any components in infusion pump assembly 400 that come in contact with the infusible fluid are disposed on and/or within disposable housing assembly 404.

In this particular embodiment of the infusion pump assembly, infusion pump assembly 400 may include switch assembly 406 positioned about the periphery of infusion pump assembly 400. For example, switch assembly 406 may be positioned along a radial edge of infusion pump assembly 400, which may allow for easier use by a user. Switch assembly 406 may be covered with a waterproof membrane configured to prevent, the infiltration of water into infusion pump assembly 400. Reusable housing assembly 402 may include main body portion 408 (housing the above-described mechanical and electrical control assemblies) and locking ring assembly 410 that may be configured to rotate about main body portion 4OB (in the direction of arrow 412),

In a fashion similar to reusable housing assembly 102 and disposable bousing assembly 1 14, reusable housing assembly 402 may be configured to releasably engage disposable housing assembly 404. Such releasable engagement may be accomplished by a screw-on, a twist-lock or a compression lit configuration. For example, In an embodiment in which a twist-lock configuration is utilized, the user of infusion pump assembly 400 may first properly position reusable housing assembly 402 with respect to disposable housing assembly 404 and may then rotate locking ring assembly 410 (in the direction of arrow 412) to releasably engage reusable housing assembly 402 with disposable housing assembly 404. Through the use of locking ring assembly 410, reusable housing assembly 402 may be properly positioned with respect to disposable housing assembly 404 and then reSeasably engaged by rotating locking ring assembly 410, thus eliminating the need to rotate reusable housing assembly 402 with respect io disposable housing assembly 404, Accordingly, reusable housing assembly 402 may be properly aligned with disposable housing assembly 404 prior to engagement, and such alignment may not be disturbed during the engagement process. Locking ring assembly 410 may include a latching mechanism (not shown) that may prevent the rotation of locking ring assembly 410 until reusable housing assembly 402 and disposable housing assembly 404 are properly positioned with respect to each other. Referring also to FIGS. S 6-1 S, there is shown an alternative-embodiment infusion pump assembly 500. As with pump assembly 100, 100\ infusion pump assembly 500 may include reusable housing assembly 502 and disposable housing assembly 504.

In a fashion similar to reusable housing assembly 402, reusable housing assembly 502 may include a mechanical control assembly (that, includes at least one pump assembly and at least one valve assembly). Reusable housing assembly 502 may also include an electrical control assembly that is configured to provide control signals to the mechanical control assembly and effectuate the delivery of an infusible fluid to a user. The valve assembly may be configured to control the flow of the infusible fluid through a fluid path and the pump assembly may be configured to pump the infusible fluid from the fluid path io the user.

In a fashion similar to disposable housing assembly 404, disposable housing assembly 504 may be configured for a single use or for use for a specified period of time, e.g., e.g., three days or any other amount of time. Disposable housing assembly 504 may be configured such that any components in infusion pump assembly 500 that come in contact with the infusible fluid are disposed on and/or within disposable housing assembly 504. in this particular embodiment of the infusion pump assembly, infusion pump assembly 500 may include switch assembly 506 positioned about the periphery of infusion pump assembly 500. For example, switch assembly 506 may be positioned along a radial edge of infusion pump assembly 500, which may allow lor easier use by a user. Switch assembly 506 may be covered with a waterproof membrane and/or an o-ring or other sealing mechanism may be included on the stem 507 of the switch assembly 506 configured to prevent the infiltration of water into infusion pump assembly 500. However, io some embodiments, switch assembly 506 may include an overniolded rubber button, thus providing functionality as a waterproof seal without the use of a waterproof membrane or an o-ring. However, to still other embodiments, the overmolded robber button may additionally be covered by a waterproof membrane and/or include an o-ring. Reusable housing assembly 502 may include main body portion 508 (housing the above-described mechanical and electrical control assemblies) and locking ring assembly 510 thai may be configured to rotate about main body portion 508 (in the direction of arrow 512). hi a fashion similar to reusable housing assembly 402 and disposable housing assembly 404, reusable housing assembly 502 may be configured to rdeasably engage disposable housing assembly 504. Such reteasable engagement may be accomplished by a screw-on, a twist-lock or a compression fit configuration, for example. In an embodiment in which a twist-Sock configuration is utilized, the user of infusion pump assembly 500 may first properly position reusable housing assembly 502 with respect to disposable housing assembly 504 and may then rotate locking ring assembly 510 (in the direction of arrow 512} to releasabϊy engage reusable housing assembly 502 with disposable housing assembly 404. As locking ring assembly 510 included within infusion pump assembly 500 may be taller (i.e., as indicated by arrow 514) than locking ring assembly 410, locking ring assembly 510 may include a passage 516 through which button 506 may pass. Accordingly, when assembling reusable housing assembly 502, locking ring assembly 510 may be installed onto main body portion 50S (in the direction of arrow 5 18). Once locking ring assembly 510 is installed onto main body portion 508, one or more Socking tabs (not shown) may prevent locking ring assembly 510 from being removed from main body portion 508. The portion of switch assembly 506 that protrudes through passage 516 may then be pressed into main body portion 508 (in the direction of arrow 520), thus completing the installation of switch assembly 506, Although button 506 is shown in various locations on infusion pump assembly 500, button 506, in other embodiments, may be located anywhere desirable on infusion pump assembly 500.

Through the use of locking ring assembly 510, reusable housing assembly 502 may^¬ be properly positioned with respect to disposable housing assembly 50-4 and then reieasably engaged by rotating locking ring assembly 510. thus eliminating the need to rotate reusable housing assembly 502 with respect to disposable housing assembly 504. Accordingly, reusable housing assembly 502 may be properly aligned with disposable housing assembly 504 prior to engagement, and such alignment may not be disturbed during the engagement process. Locking ring assembly 510 may include a latching mechanism (not shown) thai prevents the rotation of lockiπg ring assembly 510 until reusable housing assembly 502 and disposable housing assembly 504 are properly positioned with respeei to each other. Passage 516 way be elongated to allow for the movement of Socking ring 510 about switch assembly 506.

Referring also to FKJS. 19A-I9B & 20-2 K there are shown various views of infusion pump assembly 500, which is shown to include reusable housing assembly 502, switch assembly 506, and main body portion 508. As discussed above, main body portion 508 may include a plurality 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 enhance clarity, printed circuit board 600 lias been removed from FIG. U⁾B to allow for viewing of the various components positioned beneath printed circuit board 600.

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

As discussed above, volume sensor assembly 148 may be configured to monitor the amount of fluid infused by infusion pump assembly 500, For example, volume sensor assembly 148 may employ acoustic volume sensing, which is the subject of U.S. Patent Nos. 5,575,3 !0 and 5,755,683 assigned to DEKA Products Limited Partnership, as well as the U.S. patent application Publication Nos. US 2007/022807! A L US 2007/0219496 Λl , US 2007/0219480 A L US 2007/0219597 A l , the entire disclosures of all of which are incorporated herein by reference.

Vibration motor assembly 602 may be configured to provide a vibration-based signal to the user of infusion pump assembly 500. For example, in the event that the voltage of battery 606 (which powers infusion pump assembly 500) is below the minimum acceptable voltage, vibration motor assembly 602 may vibrate infusion pump assembly 500 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 above-described shape memory actuator (e.g. shape memory actuator 1 12), As discussed above, shape memory actuator S 12 may be, for example, a conductive shape-memory alloy wire that changes shape with temperature. The temperature of shape-memory actuator 1 12 may be changed with a heater, or more conveniently, by application of electrical energy. Accordingly, one- end of shape memory actuator 1 12 may be rigidly affixed (i.e., anchored) to shape memory actuator anchor 604 and the other end of shape memory actuator 1 12 may be applied to e.g. a valve assembly and/or a pump actuator. Therefore, by applying electrical energy to shape memory actuator S 12. the length of shape memory actuator 1 12 may be controlled and, therefore, the valve assembly and/or the pump actuator to which it is attached may be manipulated.

Antenna assembly 608 may be configured to allow for wireless communication between e.g. infusion pump assembly 5(K) and remote control assembly 300 CFKJ. 1 i ). As discussed above, remote control assembly 300 may allow the user to program infusion pump assembly 500 and e.g. configure bolus infusion events. As discussed above. Infusion pump assembly 500 may include one or more valve assemblies configured Io control the flow of the infusible fluid through a fluid path (within infusion pump assembly 500) and 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 to include three valve assemblies, namely measurement valve assembly 610, volume sensor valve assembly 612, and reservoir valve assembly 614.

As discussed above and referring also to FlG. 21, the infusible fluid may be stored within reservoir 1 18. In order to effectuate the delivery of the infusible fluid to the user, the processing logic {not shown) included within infusion pump assembly 500 may energize shape memory actuator 1 12, which may he anchored on one end using shape memory actuator anchor 604. Referring aSso to FIG. 22A₊ shape memory actuator 112 may result in the activation of pump assembly 106 and reservoir valve assembly 614, Reservoir valve assembly 614 may include reservoir valve actuator 614A and reservoir valve 6Ϊ4B, and the activation of reservoir valve assembly 614 may result in the downward displacement of reservoir valve actuator 614A and the closing of reservoir valve 6I4B, resulting in the effective isolation of reservoir 118. Further, pump assembly 106 may include pump plunger 106 A and pump chamber 106B and the activation of pump assembly 106 may result in pump plunger I06A being displaced in a downward fashion into pump chamber J 0613 and the displacement of the infusible fiυid (in the direction of arrow 616),

Vo! urn e sensor valve assembly 612 may include volume sensor valve actuator 6 S2A and volume sensor valve 612B. Referring also to FIG. 22B, volume sensor valve actuator 612A may be closed via a spring assembly that provides mechanical force to seal volume sensor valve 612B. However, when pump assembly 106 is activated, if the displaced infusible fluid is of sufficient pressure to overcome the mechanical sealing force of volume sensor valve assembly 612, the displacement of the infusible fluid occurs in the direction of arrow 61 S. This may result in the filling of volume sensor chamber 620 included within volume sensor assembly 148. Through the use of speaker assembly 622, port assembly 624, reference microphone 626, spring diaphragm 628. invariable volume microphone 630. volume sensor assembly 148 may determine the volume of infusible fluid included within volume sensor chamber 620. Referring also to FlG. 22C once the volume of infusible fluid included within volume sensor chamber 620 is calculated, shape memory actuator 632 may be energized, resulting in the activation of measurement valve assembly 610, which may include measurement valve actuator 6 S OA and measurement valve 6 S OB. Once activated and due to the mechanical energy asserted on 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 body of the user.

Referring also to FiCr. 23, there is shown an exploded view of infusion pump assembly 500. Shape memory actuator 632 may be anchored (on a first &vi) 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 with respect to the various other components of in fusion pump assembly 500. Valve assembly 638 may be used in conjunction with shape memory actuator 1 12 to activate pump plunger 106A. Measurement valve 6 SOB, volume sensor valve 612B and/or reservoir valve 614B may be self-contained valves that are configured to allow for installation during assembly of infusion pump assembly 500 by pressing the valves upward into the lower surface of main body portion 508. Referring also to FlG. 24 & FIGS. 25A-25D, there is shown a more-detailed view of pump assembly 106. Pump actuator assembly 644 may include pump actuator support structure 646, bias spring 648, and lever assembly 650.

Referring also to FJGS. 28A-28D, infusion pump assembly 500 may include measurement valve assembly 6S O. As discussed above, valve assembly 638 may be activated via shape memory actuator 632 and actuator assembly 640, Accordingly, to infuse the quantity of infusible fluid stored within volume sensor chamber 620, shape memory actuator 632 may need to activate valve assembly 638 for a considerable period of time (e.g. one minute or more), As ihis would consume a considerable amount of power from battery 606, measurement valve assembly 610 may allow for the temporary activation of valve assembly 638, at which point measurement valve latch 656 may prevent valve assembly 638 from returning to us non-activated position. Shape memory actuator 652 may be anchored on a first end using electrical contact 654. The other end of shape memory actuator 652 may be connected to a valve latch 656. When shape memory actuator 652 is activated, shape memory- actuator 652 may pull valve latch 656 forward and release valve assembly 638. As such, measurement valve assembly 610 may be activated via shape memory actuator 632. Once measurement valve assembly 6S O has been activated, valve latch 656 may automatically latch valve assembly 638 in the activated position. Actuating shape memory actuator 652 may pull valve latch 656 forward and release valve assembly 638. Assuming shape memory actuator 632 is no longer activated, measurement valve assembly 610 may move to a de-activated state once valve latch 656 has released valve assembly 638, Accordingly, through the use of measurement valve assembly 610, shape memory actuator 632 does not nceύ to be activated during the entire time that it takes to infuse the quantity of infusible lluid stored within volume sensor chamber 620.

As discussed above, the above-described infusion pump assemblies (^"e.g., infusion pumps assemblies 100, 100', 400, 500) may include an external infusion set 134 configured to deliver the infusible lluid to a user. Externa! infusion set 134 may include a cannula assembly S 36, which may include a needle or a disposable cannula 138, and tubing assembly 140. Tubing assembly 140 may be in fluid communication with reservoir 1 18, for example, by way of the fluid path, and with cannula assembly 138 for example, either directly or by way of a cannula interface 142.

Referring also to FiG. 29, there is shown an alternative embodiment infusion pump assembly 700 that is configured to store a portion of tubing assembly 140. Specifically, infusion pump assembly 700 may include peripheral tubing storage assembly 702 that is configured to allow the user to wind a portion of tubing assembly 140 about the periphery of infusion pomp assembly 700 (in a manner similar to that of a yoyo). Peripheral tubing storage assembly 702 may be positioned about the periphery of infusion pump assembly 700, Peripheral tubing storage assembly 702 may be configured as an open trough into which a portion of tubing assembly S 40 may be wound. Alternatively, peripheral tubing storage assembly 702 may include one or more divider portions 704» 706 that form a plurality of narrower troughs that may be sized to generate an interference lit between the wails of the narrower trough and the exterior surface of the portion of tubing 140. When peripheral tubing storage assembly 705 includes plurality of divider portions 704, 706. the resulting narrower troughs may be wound in a spiral fashion about the periphery of infusion pump assembly 700 (m a manner similar to the thread of a screw).

Referring also to FIGS. 30-3 L there is shown an alternative embodiment infusion pump assembly 750 that is configured to store a portion of tubing assembly 140. Specifically, infusion pump assembly 750 may include peripheral tubing storage assembly 752 that is configured to allow the user to wind a portion of tubing assembly 140 about the periphery of infusion pump assembly 750 (again, in a manner similar to that of a yoyo). Peripheral tubing storage assembly 752 may be positioned about the periphery of infusion pump assembly 750. Peripheral tubing storage assembly 752 may be configured as an open trough into which a portion of tubing assembly 140 is wound. Alternatively, peripheral tubing storage assembly 752 may include one or more divider portions 754, 756 that form a plurality of narrower troughs that may be sized to generate an interference fit between the walls of the narrower trough and the exterior surface of the portion of tubing 140. When peripheral tubing storage assembly 752 includes plurality of divider portions 754, 756, the resulting narrower trough may be wound in a spiral fashion about the periphery of infusion pump assembly 750 (again, in a manner similar to the thread of a screw).

Infusion pump assembly 750 may include tubing retainer assembly 758. Tubing retainer assembly 758 may be configured to releasably secure tubing assembly 140 so as to prevent tubing assembly S 40 from unraveling from around infusion pump assembly 750. in one embodiment of tubing retainer assembly 758, tubing retainer assembly 758 may include downward facing pin assembly 760 positioned above upward facing pin assembly 762. The combination of pin assemblies 760, 762 may define a "pinch point^'1 through which tubing assembly 140 may be pushed. Accordingly, the user may wrap tubing assembly 140 around the periphery of infusion pump assembly 750, wherein each loop of tubing assembly 140 is secured within peripheral tubing storage assembly 752 via tubing retainer assembly 758. Sn the event that the user wishes to lengthen the unsecured portion of tubing assembly 140, the user may release one loop of tubing assembly 140 from tubing retainer assembly 758. Conversely, In the event that the user wishes to shorten the unsecured portion of tubing assembly 140, the user may secure one additional loop of tubing assembly 140 within tubing retainer assembly 758.

Referring also to FIGS. 32-33. there is shown an exemplary embodiment of infusion pump assembly 800. As with infusion pump assemblies ! 00, 100', 400, and 500, infusion pump assembly SOO may include reusable housing assembly 802 and disposable housing assembly 804.

With reference also to FIGS, 34A-34B, in a fashion similar to infusion pump assembly 100, reusable housing assembly 802 may be configured to reieasably engage disposable housing assembly 804. Such releasable engagement may be effectuated by a screw-on, twist-lock, or compression fit configuration, for example. Infusion pump assembly 800 may include Socking ring assembly 806. For example, reusable housing assembly 802 may be properly positioned relative to disposable housing assembly, and locking ring assembly 806 may be rotated to reieasable engage reusable housing assembly 802 and disposable housing assembly 804.

Locking ring assembly 806 may include nub 808 that may facilitate rotation of locking ring assembly 806. Additionally, the position of nub 808, e.g., relative to tab 810 of disposable housing assembly 804. may provide verification that reusable housing assembly 802 is fully engaged with disposable housing assembly 804. For example, as shown in FlG. 34Λ, when reusable housing assembly 802 is properly aligned with disposable housing assembly 804, nub 808 may be aligned in a first position relative to tab 810. Upon achieving a fully engaged condition, by rotation locking ring assembly 806. nub 808 may be aligned in a second position relative to tab 810, as shown in FlG. 34B.

Referring also to FIGS. 35A-35C and FtGS. 36-38A, in a fashion similar to reusable housing assembly 102, reusable housing assembly 802 may include mechanical control assembly 812 (e.g., which may include valve assembly 814, shown in FIG. 36, including one or more valves and one or more pumps for pumping and controlling the How of the infusible fluid). Reusable housing assembly 802 may also include an electrical control assembly 8 ! 6 that may be configured to provide control signals to ihe mechanical control assembly 812 Io effectuate the delivery of an infusible fluid to the user. Valve assembly 814 may be configured to control the flow of the infusible fluid through a fluid path and the pump assembly may be configured to pump the infusible fluid from the fluid path to the user.

Mechanical control assembly 812 and electrical control assembly Sl 6 may be contained within a housing defined by base plate 818. body 820. In some embodiments one or more of base plate 8 ! 8 and body 820 may provide electromagnetic shielding. Jn such an embodiment; the electromagnetic shielding may prevent and/or reduce electromagnetic interference received by electrical control assembly 816 and/or created by electrical control assembly 816. Additionally / alternatively, EMI shield 822 may be included, as shown in FIG. 36 and FIG. 37. HMI shield 822 may provide shielding against generated and/or received electromagnetic interference.

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, or the like) The switch assembly may include button 824 that may be disposed in opening 826 of body 820. As shown, e.g., in FlG. 35B, locking ring assembly 806 may include radial slot 828 that may be configured to allow locking ring assembly 806 to be rotated relative to body 820 while still providing facile access to button 824.

Referring also to FiCrS. 3°..4-39C, electrical control assembly 816 may include printed circuit board 830 as well as battery 832, Printed circuit board 830 may include the 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 just been dispensed, and determine, based upon the dosage required by the user, whether enough infusible fluid has been dispensed. Sf not enough infusible fluid has been dispensed, electrical control assembly 816 may determine that more infusible fluid should be pumped. Electrical control assembly 816 may- provide i lie appropriate signal to mechanical control assembly 812 so that any additional necessary dosage may be pumped or electrical control assembly 816 may provide the appropriate signal to mechanical control assembly 812 so that the additional dosage may be dispensed with the next dosage. Alternatively, if too much infusible fluid has been dispensed, electrical control assembly 816 may provide the appropriate signal to mechanical control assembly 812 so that less infusible fluid may be dispensed in the next dosage. Electrical control assembly 8 16 may include one or more microprocessors:, In an exemplary' embodiment, electrical control assembly 816 may include three microprocessors. One processor (e.g., which may include, but is not limited Lo a CC25 IO microcontroller / RF transceiver, available from €hipcon AS, of Oslo, Norway) may be dedicated to radio communication, e.g.. for communicating with a remote control assembly. Two additional microprocessors (example of which may include, but is not limited io an MSP430 microcontroller, available from Texas Instruments Inc. of Dallas, Texas) .may be dedicated to issuing and carrying out commands {e.g., to dispense a dosage of infusible fluid, process feedback signals from a volume measurement device, and the like).

As shown in FIG. 35C, base plate 81 S may provide access to electrical contacts 834, e.g., which may be electrically coupled to electrical control assembly 816 for recharging battery 832. Base plate SI S may include one or more features (e.g., openings 836, 838} which may be configured to facilitate proper alignment with disposable housing assembly 804 by way of cooperating features (e.g., tabs) of disposable housing assembly 804. Additionally, as shown in FIGS. 40A-40C, 41 A-41 B, and 42A-42C, base pϊate 81 S may include various features for mounting valve assembly 814 and electrical control assembly 816, as well as providing access to disposable housing assembly 8(W by valve assembly 814.

Locking ring assembly 806 may include grip inserts 840, 842, e.g., which may include an elastomeric or textured material that may facilitate gripping and twisting locking ring assembly 806, e.g., for engaging / disengaging reusable bousing assembly 802 and disposable housing assembly 804. Additionally, locking ring assembly 806 may include a sensing component {e.g., magnet 844) that may interact with a component of reusable housing assembly 802 (e.g., a Hall Effect sensor), e.g., to provide an indication of the nature 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 of whether reusable housing assembly 802 is properly engaged with the mating component. In the exemplary embodiment, a Hall Effect sensor {not shown) may be located on the pump printed circuit board. The Mall Effect sensor may detect when the locking ring has been rotated to a closed position. Thus, the Hall Effect sensor together with magnet 844 may provide a system for determining whether the locking ring has been rotated to a closed position.

The sensing component (magnet) 844 together with the reusable housing assembly components, i.e., in the exemplary embodiment, the HaSl Effect sensor, may work to provide for a determination of whether the reusable housing assembly is properly attached to the intended component or device. Locking ring assembly 806 may not turn without being attached to a component, i.e., disposable housing assembly 804, a dust cover or a charger. Thus, the sensing component together with the reusable housing assembly component may function to provide many advantageous safety features to the infusion pump system. These features may include, but are not limited to, one or more of the following. Where the system does not detect being attached to a disposable assembly, a dust cover or a charger, the system may notify, alert or alarm the user as the reusable portion, e.g., the valves and pumping components, may be vulnerable to contamination or destruction which may compromise the integrity of the reusable assembly. Thus, the system may provide for an integrity alarm to alert the user of potential reusable integrity threats. Also, where the system senses the reusable assembly is attached to a dust cover, the system may power off or reduce power to conserve power. This may provide for more efficient use of power where the reusable assembly is not connecting to a component in which it needs to interact, Reusable housing assembly S02 may attach to a number of different components, including but not limited to, a disposable housing assembly, a dust cover or a battery chargcr/batter>' charging station. In each case, the Hall Effect sensor may detect that the locking ring is in the closed position, and therefore, that reusable housing assembly 802 is reSeasabiy engaged to a disposable housing assembly, a dust cover, or a battery charger^batiery charging station (or, another component}. The infusion pump system may determine the component to which it is attached by using the AVS system described in more detail below or by an electronic contact. Referring now also to FIGS. 38B-38D, one embodiment of a dust cover {e.g., dust cover 839) is shown. Sn the exemplary embodiment, dust cover 839 may include features 84 ! , 843, 845, 847 such that the locking ring of reusable housing assembly 802 may reSeasabiy engage dust cover 839. In addition, dust cover 839 may further include recess region 84*-⁾ for accommodating the vaiving and pumping features of reusable housing assembly 804. For example, with respect to the dust cover, the AVS system may determine thai a dust cover, and not a disposable housing assembly, is connected to the reusable housing assembly. The AVS system may distinguish usiBg a look-up table or other comparative data and comparing the measurement data with characteristic dust cover or empty disposable housing assembly data. With respect to the battery charger, the battery charger, in the exemplary embodiments, may include electric contacts. When the reusable housing assembly is attached to the battery charger, the infusion pump assembly electronic system may sense that the contacts have been made, and will thus indicate that the reusable housing assembly is attached to a battery charger.

Referring also to FIGS. 43A-45B and FKiS. 44A-44C an embodiment of valve assembly 814, which may include one or more valves and (me or more pumps, is shown. As with infusion pump assemblies 100, 100', 400, and 500, valve assembly 814 may generally include reservoir valve 850, plunger pump 852, volume sensor valve 854, and measurement valve 856. Similar to ihe previous description, reservoir valve 850 and plunger pump 852 may be actuated by shape memory actuator 858, which may be anchored (on 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 (on a first end) to shape memory actuator anchor 866. in a similar manner as discussed above, measurement valve may be maintained in an open position via measurement valve latch assembly 868. Measurement valve 856 may be released via actuation of shape memory actuator 870, which may be anchored (on a first end) by shape memory actuator anchor 872. In some embodiments, shape memory actuator anchor 860 may be potted onto the reusable housing assembly. Using this process during manufacture ensures shape memory length actuator 858 is installed and maintains the desired length and tension/strain.

Referring also to FIGS, 45A-45B and FSGS. 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 S74 may include bias spring 876 and lever assembly 878. Actuator assembly 874 may actuate both plunger pump 852 and measurement valve 850.

Referring also to FIGS. 47A-47B, measurement valve 856 may be actuated by shape memory actuator 864. via valve actuator 862 and lever assembly 878, Once actuated, measurement valve latch assembly 868 may maintain measurement valve 856 in an open position. Measurement valve latch assembly 868 actuated by shape memory actuator 870 to release measurement valve 856, allowing it to return to a closed position. Disposable housing assembly 804 may be configured for a single use or for use for a specified period of time, e.g., e.g., three days or any other amount of time. Disposable housing assembly 804 may be configured such thai any of the component of infusion pump assembly 800 that come in contact with the infusible fluid may be disposed on and/or within disposable housing assembly 804. As such, the risk of contaminating the infusible fluid may be reduced.

Referring also to FSG. 48 and FIGS. 49A-4^QC, disposable housing assembly 804 may include base portion 900, membrane assembly 902, and top portion 904. Base portion 900 may include recess 906 thai together with membrane assembly 902 defines reservoir 908 for receiving an infusible fluid (not shown), e.g., insulin. Referring also to FIGS. 50A- 50C, recess 906 may be at least partially formed by and integral with base portion 900. Membrane assembly 902 may be sealingly engaged with base portion 900, e.g., by being compressively pinched between base portion 900 and top portion 904. ^"fop portion 904 may be attached to base portion 900 by conventional means, such as gluing, heat sealing, ultrasonic welding, and compression fitting. Additionally / alternatively, membrane assembly 902 may be attached to base portion 900. e.g., via gluing, ultrasonic welding, heat sealing, and the like, to provide a seal between membrane assembly 902 and base portion 900.

Still referring to FIGS. 48 and 50A, recess 906, in the exemplary embodiment, includes raised portion 901 which includes area 903 about fluid openings 905 leading to the fluid line. Raised portion 901 , in the exemplary embodiment, extends about, the perimeter of recess 906. However, in other embodiments, raised portion 90 ϊ may not extend the entire perimeter, but may be partially about the perimeter. Area 903 about fluid openings 905 may be shaped as shown in the exemplary embodiment, including an angled portion, which in some embodiments, includes 45 degree angles, however in other embodiments, the angle may be greater or lesser, in some embodiments, the pump may not generate a sufficient enough vacuum to collapse the reservoir so as to eliminate the entire volume of fluid that may be stored in the reservoir. Raised portion 901 may act to minimize wasted fluid. Fluid openings 90S, which, in the exemplary embodiment, may include three openings, however, in other embodiments may include more openings or fewer openings. may be surrounded by area 903 of the raised portion. In the exemplary embodiment, fluid openings 905 may be narrow in the center, thus creating a surface tension that may prevent the air from being drawn into the opening. In (he exemplary embodiment, this area may be designed to encourage any air that is present in the reservoir to be drawn above one of fluid openings 905 rather than be pulled through fluid openings 905 and into the fluid line. Additionally, because there may be more than one fluid opening ¹JOS, where an air bubble is caught above one, the air may not prevent fluid irorn {lowing through the other two openings.

Referring also to FSGS. 51 A-SlC disposable housing assembly 804 may also include fluid pathway cover 910. Fluid pathway cover 910 may be received in cavity 912 formed on / within base portion 900, Fluid pathway cover 910 may, in some embodiments, include at least a portion of one or more channels (e.g., channel 914). The channels included in fluid pathway cover 910 may fluidly couple one or more volcano valve features (e.g. volcano valves 916) included on base portion 900. Volcano valves 916 may include a protrusion having an opening extending through it. Additionally, fluid pathway cover 910 and base portion 900 may each define a portion of recess (e.g., recess portions 918, 920 included in base portion 900 and fluid, pathway cover 910 respectively) for iluidly coup! ing 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, compression fit, or the like). The fluid pathways defined by fluid pathway cover 910 and the volcano valves (e.g., volcano valves 916) of base portion 900 may define a fluid pathway between reservoir 908 and cannula 922 for die delivery of the infusible fluid to the user via the infusion set. However, in some embodiments, fluid, pain cover 910 may include ai least a portion of the fluid path, and in some embodiments, fluid path cover 910 may not include at least a portion of the fluid path. In the exemplary embodiment, fluid pathway cover 910 may be laser welded to base portion 900. However, in other embodiments, fluid pathway cover 910 may also be connected to base portion 900 by conventional means {e.g., gluing, heat sealing, ultrasonic welding, compression fit, or the like} to achieve a generally fluid tight seal between fluid pathway cover 910 and base portion 900.

With reference also to FKlS. 54Λ-54C, disposable housing assembly 804 may further include valve membrane cover 924. Valve membrane cover 924 may be at least partially disposed over the volcano valves {e.g., volcano valve 916) and pumping recess 926 included on / within base portion 9(KK Valve membrane cover 924 may include a flexible material, e.g., which may be selectively engaged against the volcano valves by reservoir valve 850, volume sensor valve 854, and measurement valve 856 of reusable housing assembly 802, e.g., for controlling the flow of the infusible fluid. Additionally, valve membrane cover 924 may be resiliently deformed into pumping recess 926 by plunger pump 852 to effectuate pumping of the infusible fluid. Valve membrane cover 924 may be engaged between base portion 900 and top portion 904 of disposable housing assembly 804 to form sea! 928 between valve membrane cover 924 and base portion 900. For example, in the exemplary embodiment, valve membrane cover 924 may be overmoided onto base portion 900. Sn other embodiment, valve membrane cover 924 may be compressive ty pinched between base portion 900 and top portion 904 to form seal 928. Additionally / alternatively, valve membrane insert may be connected to one or more of base portion 900 and top portion 904, e.g., by gluing, heat sealing, or the like.

Referring also to FIGS. 53A-C, top portion 904 may include alignment tabs 930, 932 that may be configured to be at least partially received in openings 836, 838 of base plate 81 8 of reusable housing assembly S02 to ensure proper alignment between reusable housing assembly 802 and disposable housing assembly 804. Additionally, top portion 904 may include one or more radial tabs 934, 936, 938, 940 configured to be engaged by cooperating tabs 942, 944, 946, 948 of locking ring assembly 806, The one or more radial tabs (e.g., radial tab 940} may include stops {e.g., alignment tab stop 950, which may be used for welding, it's the tab that fits in the recess to locate and itltrasonieaily weld), e.g., which may prevent further rotation of locking ring assembly 806 once reusable housing assembly 802 and disposable housing assembly 804 are fully engaged.

As discussed above, valve membrane insert 924 may allow for pumping and flow of the infusible fluid by reservoir valve 850, plunger pump 852, volume sensor valve 834, and measurement valve 856. Accordingly, top portion 904 may include one or more openings (e.g., openings 952, 954, 956} that may expose at least a portion of valve membrane insert 924 for actuation by reservoir valve 85O₁ plunger pump 852, volume sensor valve 854, and measurement valve 856. Additionally, top portion 904 may include one or more openings 958, 960, 962 which may be configured to allow the fill volume to be controlled during filling of reservoir 90S, as wiSS be discussed in greater detail below. Reservoir assembly 902 may include ribs 964, 966, 968 (e.g., as shown in FlO, 52A), which may be at least partially received in respective openings 958, 96(1 962. As will be described in greater detail below, a force may be applied to one or more of ribs 964, 966, %8 to, at least temporarily, reduce the volume of reservoir 908. Cn some embodiments, it may be desirable to provide a sea! between reusable housing assembly S02 and disposable housing assembly 804. Accordingly, disposable housing assembly 804 may include sealing assembly 970. Sealing assembly 970 may include, for example, an eiastonierie member that may provide a compressible rubber or plastic layer between reusable housing assembly 802 and disposable bousing assembly 804 when engaged, thus preventing inadvertent disengagement and penetration by outside fluids. For example, sealing assembly 970 may be a watertight seal assembly and, thus, enable a user to wear infusion pump assembly SOO while swimming, bathing or exercising, ϊn a fashion similar to, e.g., disposable housing assembly 1 14, disposable housing assembly 802 may, in some embodiments, be configured to have reservoir 90S tilled a plurality of times. 1 ϊowever, in some embodiments, disposable housing assembly i 14 may be configured such that reservoir 90S may not be refilled. Referring also to FIGS. 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 tabs 1002, S 004, .1006, 1008 that may be configured to engage radial tabs 934, 936, 938, 940 of disposable housing assembly 804 in a manner generally similar to tabs 942, 944, 946, 94S of locking ring assembly 806 Accordingly, 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 one another to releasabiy engage locking tabs 1002, 1004, 1006, 1008 wHh radial tabs 934. 936, 938, 940.

Fill adapter 1000 may further include 01 ling aid 1010. which may include guide passage 1012, e.g., which may be configured to guide a needle of a syringe {not shown) to a septum of disposable housing assembly 804 to allow reservoir 908 of disposable bousing assembly 804 to be filled by the syringe, tn some embodiments, guide passage 1012 maybe an angled bevel or other gradual angled bevel Io further guide a syringe to a septum. FiSS adapter 1000 may facilitate filling reservoir 908 by providing a relatively large insertion area, e.g., at the distal opening of guide passage 1012. Guide passage 1012 may generally taper to a smaller proximal opening that may be properly aligned with the septum of disposable housing assembly 804. when fill adapter 1000 is engaged with disposable housing assembly 80-*. Accordingly, fill adapter 1000 may reduce the dexterity and aim necessary to properly insert a needle through the septum of disposable housing assembly 804 for the purpose of filling reservoir 908. As discussed above, disposable housing assembly 804 may configured to facilitate controlling the quantity of infusible fluid delivered to reservoir 908 during tilling. For example, membrane assembly 902 of disposable housing assembly 804 may include ribs 964, 966, 968 thai may be depressed and at least partially displaced into reservoir 908, thereby reducing the volume of reservoir 908. Accordingly, when infusible fluid is delivered to reservoir 908, the volume of fluid that may be accommodated by reservoir 908 may be correspondingly reduced. Ribs 964, 966, 968 may be accessible via openings 958, 960, 962 in top portion 904 of disposable housing assembly 804.

Fill adapter 1000 may include one or more button assemblies (e.g., button assemblies ! 014, 1016, 1018} corresponding to ribs 964, 966, 968. That is, when fill adapter 1000 is relcasably engaged with disposable housing assembly 804, buttons 1014, 1016, 1018 may be aligned with ribs 964, 966, 968. Button assemblies 1014, 1016, 1018 may be, for example, cantilever members capable of being 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 may correspo.ndi.ngly displace a respective one of ribs 964, 966, 698 into reservoir 908, causing an attendant reduction in the volume of reservoir 908.

For example, assume for illustrative purposes that reservoir 908 has a maximum capacity of 3.00 mL. Further, assume that button assembly 1014 is configured to displace rib 964 into disposable housing assembly 804, resulting in a 0.5 ml, reduction in the 3.00 ml, capacity of disposable housing assembly 804. further, assume that button assembly 1016 is configured to displace rib 966 into disposable housing assembly 804, also resulting in a 0.5 ml., reduction in the 3.00 mL capacity of disposable housing assembly 804. Further, assume that button assembly 1018 is configured to displace slot assembly 968 into disposable housing assembly 804, also resulting in a 0,5 mL reduction in ihe 3.00 mL capacity of disposable housing assembly 804. Therefore, if the 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 the 3.00 mL capacity and then depresses button assemblies 1016 and 1014 (resulting in the displacement of rib 966 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 respective number of button assemblies, effectively reducing the capacity of reservoir 908, and then fill reservoir 908. Although a particular number of button assemblies are shown, representing the exemplary embodiment, in other embodiments, the number of button assemblies may vary from a minimum of S to as many as is desired. Additionally, although for descriptive purposes, and in the exemplary embodiment, each button assembly may displace 0.5 mL, in other embodiments, the volume of displacement per button may vary. Additionally, the reservoir may be, in various embodiments, include a larger or smaller volume than described in the exemplary embodiment.

According to the above-described configuration, the button assemblies {e.g., button assemblies 1014. 1016, 108} may employed, at least in part, to control the fill volume of reservoir 908. By not depressing any of the button assemblies, the greatest ill! volume of reservoir 908 may be achieved. Depressing one button assembly (e.g.. button assembly 1014} may allow the second greatest fill volume to be achieved. Depressing two button assemblies {e.g., button assemblies 1014, 1016} may achieve the third greatest till volume. Depressing all three button assemblies {e.g., button assemblies 1014, 1016, H)I S) may allow the smallest till volume to be achieve, Further, in an embodiment button assemblies 1014, 1016, 1018 may be utilized, at least in part, to facilitate filling of reservoir 908. For example, once a filling needle (e.g., which may be fluidly coupled to a vial of infusible fluid) has been inserted into reservoir 908, button assemblies 1014, 1016, 1018 may be depressed to pump at least a portion of any- air that may be contained within reservoir into the vial of infusible fluid. Button assemblies 1014, 1016, 1018 may subsequently be released to allow infusible fluid to flow from the vial into reservoir 908. Once reservoir 90S lias been filled with the infusible fluid, one or more button assemblies (e.g., one or more of button assemblies 1014, 1016, 1018} may be depressed, thereby squeezing at least a portion of the infusible fluid from reservoir 908 (e.g., via a needle used to fill reservoir 908 and back into the vial of infusible fluid). As discussed above, the volume of infusible OuId contained within reservoir 908 may be controlled, e.g., depending upon how many button assemblies are depressed (e.g., which may control how much infusible lluid is squeezed back into the vial of infusible fluid).

With particular reference to FICJS. 62-64, filling aid 1010 may be pivotal Iy coupled to fill adapter base plate 1020. For example, Hl ling aid 1010 may include pivot members 1022, 1024 that may be configured to be received in pivot supports 1026, 1028, thereby allowing filling aid to pivot between an open position {e.g., as shown in FIGS. 57-61 } and a closed position {e.g., as shown in FtGS. 63-64), The closed position may be suitable, e.g., for packaging fill adapter 1000, storage of fill adapter 1000, or the like. In order to ensure that filling aid 1010 is properly oriented for filling reservoir 908, fill adapter If)OO may include support member 1030. To properly orient filling aid 1010. a user may pivot filling aid iOlø to a fully open position, wherein filling aid 10! 0 may contact support member 1030. According to an alternative embodiment, and referring also to FICi. 65, till adapter

1050 may be configured to releasabiy engage disposable housing assembly 804 via a plurality of locking tabs (e.g., locking tabs 1052. 1054}. Additionally, fill adapter 1050 may include a plurality of button assemblies (e.g., button assemblies 1056, 1058, 1060) that may interact with ribs 964, 966, 968 of disposable housing assembly 804 to adjust a fill volume of reservoir 908. Fill adapter 1050 may further include filling aid 1062, having guide passage 1064 configured to align a needle of a syringe with the septum of disposable housing 804, e.g,, for accessing reservoir 908 for the purpose of Oiling reservoir 90S with an infusible fluid. Filling aid S 062 may be connected to base plate 1066, e.g., as an integral component therewith, by gluing, heat sealing, compression fu, or the like. Referring also to FIGS. 66-74, vial til! adapter 1 100 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 1 100 may include locking tabs 1 102, 1 104, 1 106, 1 108 thai may be configured to engage radial tabs 934, 936, 938, 940 of disposable housing assembly in a manner generally similar to tabs 942, 944, 946, 948 of locking ring assembly 806. Accordingly, vial fill adapter 1 100 may be releasabiy engaged with disposable housing assembly 804 by aligning vial fill adapter i 100 with disposable housing assembly 804 and rotating vial fill adapter S 100 and disposable bousing assembly 804 relative to one another to releasabiy engage locking tabs 1 102, 1 104, 1 106, 1 108 with radial tabs 934, 936, 938. 940. As discussed above, disposable housing assembly 804 may be configured to facilitate controlling the quantity of infusible Ouid delivered to reservoir 908 during filling. For example, membrane assembly 902 of disposable housing assembly 804 may include ribs 964, 966. 968 that may be depressed and at least partially displaced into reservoir 90S, thereby reducing tlie volume of reservoir 908. Accordingly, when infusible fluid is delivered to reservoir 908. the volume of fluid that may be accommodated by reservoir 908 may be correspondingly reduced. Ribs 964, 966, 968 may be accessible via openings 958, 960, 962 in top portion 904 of disposable housing assembly 804. Vial fill adapter ! 100 may include one or more button assemblies (e.g., button assemblies 1 1 HX S 1 12, 1 114) corresponding to ribs 964, 966, 968 (e.g., shown in FlG. 52A). That is, when vial fill adapter 1 100 is releasabiy engaged with disposable housing assembly 804, buttons H 10J 1 12, 1 1 14 may be aligned with ribs 964, %6, 968. Button assemblies 1 1 10, 1112, 1 1 14 may be, for example, cantilever members capable of being depressed. When vial fill adapter 1 100 is releasabiy engaged with disposable housing assembly 804, one or more of button assemblies U lO, 1 1 12, 1 1 14 may be depressed, and may correspondingly displace a respective one of ribs 964, 966, 698 into reservoir 908, thereby reducing the volume of reservoir 908. For example, assume for illustrative purposes that reservoir 908 has a maximum capacity of 3.00 ml... Further, assume that button assembly L l 10 is configured to displace 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. Further, assume that button assembly 1 1 12 is configured to displace rib 966 into disposable housing assembly 80-4, also resulting in a 0.5 ml., reduction in the 3.00 ml. capacity of disposable housing assembly 804, Further, assume that button assembly 1 1 14 is configured to displace rib %8 into disposable housing assembly 804, also resulting in a 0.50 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Therefore, 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 1 1 12 and 1 1 14 (resulting in the displacement of ribs %6 and 968 into disposable housing assembly 804), effectively reducing the 3.00 ml. capacity of reservoir 908 within disposable housing assembly 804 to 2,0 mL.

Vial fill adapter 1 100 may further include via! filling aid assembly 1 1 16 that may be configured to fiuidiy couple a vial of infusible fluid to reservoir 908 of disposable housing assembly 804 via a septum. With particular reference to FIG. 71, vial tilling aid assembly may include double ended needle assembly ! 1 L 8. Double ended needle assembly 1 118 may include first needle end 1 120 configured to penetrate the septum of a vial (not shown) and second needle end 1 122 configured to penetrate the septum of disposable housing assembly 804, As such, the via! and reservoir 908 may be lluidry coupled allowing infusible fluid to be transferred from the vial to reservoir 908. Double ended needle assembly 1118 may include vial engagement portion L 124 adjacent first end 1 120. Vial engagement arms 1 124, 1 126 may be configured to releasabiy engage, e.g., a vial cap, Io assist in maintaining the fluid connection between double ended needle assembly 1 1 18 and the vial. Additionally, double ended needle assembly ! 1 18 may include body 1 128 thai may be slidably received in opening I ! 30 of vial filling aid body U 32, Via! filling aid body 1 132 may include stabilizer arms S S 34, 1 136, e.g., which may be configured to stabilize the vial during filling of disposable housing assembly SW. in one embodiment, the vial may be engaged with double ended needle assembly 1 1 18 e.g., such that first end 1 120 may penetrate the septum of the vial and the cap of the vial may be engaged by engagement arms 1 ! 24, 1126. Body 1 128 may be slidably inserted into opening ! 130 such that second end 1122 of double ended needle assembly 1 1 1 S may penetrate the septum of disposable body assembly 804.

Similar io fill adapter i 000, vial filling aid assembly 1 116 may be configured to be pivotally coupled to vial fill adapter base plate 1 138. For example, vial filling aid 1 1 16 may include pivot, members i 140, 1 142 that may be configured to be received in pivot supports 1 144. 1 146 {e.g., shown in FIG. 71 }, thereby allowing vial filling aid 1 1 16 to pivot between an open position (e.g., as shown in FIGS. 66-70} and a closed position (e.g., as shown ^*tn FIGS. 72-74). The closed position may be suitable, e.g., for packaging vial fill adapter 1 100, storage of vial fill adapter 1 100, or the like, ϊn order to ensure that vial filling aid

1 1 16 is properly oriented for tilling reservoir 90S, vial fill adapter 1 100 may include support member 1 148. To properly orient vial fill ing aid 1 1 16, a user may pivot, vial filling aid 1 1 16 to a fully open position, wherein vial 111 ling aid 1 1 16 may contact support member 1 148. Additionally, vial fill adapter base plate 1 13S may include one or more locking features (e.g., locking tabs 1 150, 1 S 52) that may engage vial filing aid 1 1 16, and may maintain vial filling aid 1 1 16 in the closed position. Vial HSI adapter base plate 1 138 may also include features (e.g., tabs S 154, 1156) that may be configured to assist in retaining double ended needle assembly 1 1 18, e.g., by preventing slidable separation of double ended needle assembly 1 118 from vial filling aid body ! 132. As shown in FIGS. 72-74, fill ing aid assembly 1 116 is in a closed position. Sn this configuration, support member 1 148 may additionally function as a needle guard. When removing filling aid assembly 1 116 from disposable housing assembly 804, support member 1 148 may function to safely allow a user to squeeze the ends and rotate filling aid assembly 1 1 16 i^'or removal. As shown m FlG. 70, in the open position, support member 1 148 may function as a stop to maintain proper orientation.

Referring again to FiGS. 57-73, the exemplar}' embodiments of the fill adapter include a grip feature (e.g., 1 166 in ITG. 72). Grip feature 1 166 may provide a grip interface for removal of the fill adapter from disposable housing assembly 804. Although shown in one configuration in these figures, hi other embodiments, the configuration may van-, Sn still other embodiments, a grip feature may not be included.

According to one embodiment, fill adapter base plate 1020 and vial fill adapter base plate i i 38 may be interchangeable components. Accordingly, a single base plate (e.g., either ill! adapter base plate 1020 or via! fill adapter base plate I 138 may be used with either filling aid 1010 or vial filling aid 1 1 16. Accordingly, the number of distinct components that are required for both filling adapters may be reduced, and a user may have the ability to select the filling adapter that may be die most suitable for a given filling scenario. The various embodiments of the fill adapters may provide many safely benefits, including but not limited to: providing a system for filling the reservoir without handling a needle; protecting the reservoir from unintentional contact with the needle, i.e., destruction of the integrity of the reservoir through unintentional puncture; designed to be ambidextrous; in some embodiments, may provide a system for maintaining air in the reservoir.

According to other embodiments, the till adapter may be configured to meter the fluid dispensed into the reservoir or the disposable housing assembly. Additionally / alternatively, the fill adapter may be configured to positively dispense (e.g., pump) the fluid into the reservoir of the disposable housing assembly. For example, and referring also to FIGS, 174- 194, fill adapter 2 /00 may include a metering system for controlling the amount of fluid dispensed into the reservoir of the disposable housing assembly (e.g., reservoir 90S of disposable housing assembly 804 and a pumping mechanism for positively dispensing the fluid to reservoir 908. Generally, fill adapter 2700 may include a turn dial (e.g., turn dial 2702} that may adjust the volume of fluid to be dispensed into reservoir 908. For example, turn dial 2702 may actuate push plate 2704 { FlG. ISI)- Push plate 2704 may include one or more button features (e.g., button features 2706, 2708, 2710 shown in FΪG. 187, 188). Button features 2706, 2708, 2710 may displace one or more of ribs 964, 966, 968 associated with reservoir 908, thereby reducing the available fill volume of reservoir 908. The degree to which ribs 964, 966, 968 are displaced may determine the available fill volume of reservoir 90S (as discussed previously}, and therefore also the volume of fluid that may be dispensed into reservoir 908.

Turn dial 2702 and push plate 2704 may include cooperating features thai may enable turn dial 2702 to adjust the displacement of ribs 964, 966, 968 by push piate 2704. In one embodiment, turn dial 2702 and push plate 2704 may include cooperating ramp features, e.g., threads 2? 12 of push plate 2704 shown in FtG. I S?. Turn dial 2702 may include cooperating threads, such that when turn dial 2702 is turned in a first direction (e.g., clockwise) push plaie 2704 may be linearly moved in a first direction to displace ribs 964, 966, %8 into reservoir 908 to decrease the available fill volume of reservoir 908.

Conversely, when turn dial 2707 is turned in a second direction (e.g., counterclockwise) push plate 2704 may be linearly moved in a second direction allowing ribs 964, 966, 968 to move to increase the available fill volume of reservoir 908. In addition to cooperating ramp features, various additional / alternative features may be utilized, including, but not limited to. cam features, rack and pinion features, etc. Further, fϊ)! adapter 2700 may include one or more return features (such as springs, or other bias members; not shown) thai may ensure that push plate 2704 is biased to increase the available fill volume of reservoir 90S in response to turn dial 2702 being adjusted from a smaller available fill volume to a larger available fill volume (e.g., as turn dial 2702 is turned in a counterclockwise direction in foregoing example).

As mentioned above, fill adapter 2700 may be configured to positively dispense fluid into reservoir 908. In one embodiment, fill adapter 2700 may include a pump mechanism configured to pump air into a vial (e.g., vial 2716 shown in FlG. 181 ). For example, pumping air into vial 2716 may pressurize vial 2716 to a pressure greater than a pressure within reservoir 908, As such, when vial 2716 is tluidly coupled with reservoir 908, the greater pressure within vial 2716 may force fluid contained within vial 2716 into reservoir 90S. Consistent with the foregoing description, the volume of fluid transferred from vial 2716 into reservoir 90S may be controlled by turn dial 2702 and push plate 2704 (e.g., based upon, at least in part, the interaction between button features 2706, 2708, 27 IO and fingers 964, 966, 968). The fill adapter may include a pump mechanism. According to one embodiment, till adapter 27Ot) may include pump bulb 2718, which may include a flexible convex member that may be biased toward a first volume, and compressible to a second volume that is less than the first volume. For example, pump bulb 27! S may be compressed from the first volume to the second volume when pump bulb 271 8 is pressed by a user^'s thumb or linger. While not shown, a pumping volume (e.g., the difference between the first volume and the second volume of pump bulb 2718_.} may be controlled at least in part, by turn dial 2702, For example, the pumping volume may be controlled by turn dial 2702 to correspond to the available fill volume of reservoir 908 (e.g., the pumping volume may be a pumping volume of air that may result a transfer of a volume of fluid generally equal to the available fill volume of reservoir 908).

Further, while not shown, pump bulb 271 8 may include an inlet having an associated one-way valve that may allow air to enter pump bulb 2718 via the inlet when pump bulb 2718 expands from the second volume to the ϊlrsi volume, and may prevent air from exiting inlet when pump bulb 2718 is compressed from the first volume to the second volume. Additionally, while also not shown, pump bulb 2718 may include an outlet having an associated one-way valve that may allow air to exit pump bulb 2718 via the outlet when pump bulb 27! 8 is compressed from the first volume to the second volume, and may- prevent air from entering pump bulb 2718 via the outlet when pump bulb 2718 expands from the second volume to the first volume. Various valve mechanisms may be employed for the one-way inlet valve and the one-way outlet valve, including, but not limited to, ball valves, flap valves, diaphragm valves, and the like.

!n various additional / alternative embodiments the pump mechanism may include, but is not limited to, a piston pump, a diaphragm pump, or the like. Further, while pump bulb 2718 has been described as being compressed by a user's thumb or finger, various additional / alternative embodiments of a pump mechanism may be actuated by a turn crank, a lever, a pair of squeeze handles, a foot pump, and/or various other means of actuation.

The outlet of pump bulb 27S S may be fiuidly coupled to pressure needle 2720 ( FKJ. IS I ). Pressure needle 2720 may be configured to penetrate a septum of vial 2716. As such, when pressure needle 2720 has penetrated the septum of vial 2716 and pump bulb 2718 is pumped (e.g., by compressing pump bulb 271 S from the first volume to the second volume) air may be transferred from pump bulb 27! 8 into vial 2716. The transfer of air from pump bulb 2718 into vial 2716 may increase the internal pressure within vial 2716, The one way valve associated wiih the outlet of pυrap bulb 27 IS may prevent the retrograde flow of fluid from vial 2716 into pump bulb 2718 via pressure needle 2720. Additionally, as schematically shown in FIG. 194, hydrophobic filter 2722 may be associated with pressure needle 2720. Hydrophobic filter 2722 may include any variety of gas-permeable hydrophobic materials, such as a PO REX™ material a GORE™ material, or the like CPOREX is a trademark of Porex Corporation in the United States and/or other countries, GORE is a trade mark of VV. L. Gore & Associates, Inc. in the Unites States and/or other countries). Hydrophobic filter 2722 may allow the transmission of gaseous fluids (such as air), but may resist / prevent the passage of liquids (such as insulin or various other infusion fluids). Additionally, hydrophobic filter 2722 may have a restricted flow rate of gaseous fluids, and may, therefore, control the rate at which air can be pumped out of pump bulb 2718 and into vial 2716.

Fill adapter 2700 may further include a transfer needle (e.g., transfer needle 2724 shown in FlG, ISl ). Transfer needle 2724 may allow fluid to be transferred from vial 2716 to reservoir 90S of disposable housing assembly 804. Referring also to FIG, 183, in a "fill configuration" of fill adapter 2700. transfer needle 2724 may extend into recess 2726 of fill adapter 2700. Recess 2726 of fill adapter 2700 may be configured to at least partially receive disposable housing assembly 804. Further, fill adapter 2700 may be configured to align (e.g., via openings 2728, 2730 configured to cooperate with alignment tabs 930, 932 of disposable bousing assembly 804} disposable bousing assembly 804 relative to fill adapter 2700, such that transfer needle 2724 may be aligned to penetrate a septum of disposable housing assembly 804 to transfer fluid from vial 2716 into reservoir 908 of disposable housing assembly 804.

As shown in the schematic view of FlG. 194, pressure needle 2720 may be configured to extend farther imo vial 2716 than transfer needle 2724. The foregoing configuration may reduce the likelihood that air introduced into vial 2716 by pump bulb 2718 may be transferred via transfer needle 2724. That is, in operation pressure needle 2720 may be at a higher relative position within via! 2716 as compared to transfer needle 2724, As such, air bubble rising within via! 2716 (which may contain a liquid to be transferred to reservoir 90S) may not pass by, and be drawn into, transfer needle 2724, as transfer needle 2724 may be at a lower relative position within via! 2617 as compared to pressure needle. Pressure needle 2720 and transfer needle 2724 may be retained by vial adapter 2732 (FIO. J 93). Additionally, vial adapter 2732 may include vial receptacle 2734 that may be configured to at least partially receive vial 2716 and align pressure needle 2720 and transfer needle 2724 with the septum of vial 2716. As such, insertion of vial 2716 into vial receptacle 2734 may align pressure needle 2720 and transfer needle 2724 with the septum of vial 2716 without the need for further alignment by the user. Further, vial adapter 2732 may retain pressure needle 2720 and transfer needle 2724 in a desired relative alignment; such that pressure needle 2720 may extend farther into vial 2716 than transfer needle 2724, as described above. Also referring to RGS. 199A- 19911, via! adapter 2732 may be configured to be received in receptacle 2736 of main plate 2738 of fill adapter 2700 (also see FtCi, 181 ). Vial adapter 2732 may include needle carriage 2732a as well as one or more tabs (e.g.. tabs 2732b, 2732c). In some embodiments, via! 2716 may be removed from vial adapter 2732 by pulling up on. vial 2716. Pulling up on vial 2716 may also cause needle carriage 2732a to move upwards until being engaged by the tabs 2732b, 2732c. Fingers 2733a, 2733b may be depressed by the user, in some embodiments, depressing fingers 2733a, 2733b may push via! 2716 further upward, and may disconnect vial 2716 from needles 2720, 2724. As such, the safety of removing via! 2716 from vial adapter 2732 may be improved. In some embodiments, vial adapter 2732 may additionally include seal 2735a and hydrophobic filter 2735b. However, in other embodiments, the vial adapter 2732 may include a check valve. Referring also to FΪG, 184, in an embodiment pressure needle 2720 may terminate within via! adapter 2732, and may be flukily coupled to opening 2740 of via! adapter 2732. When via! adapter 2732 is assembled with main plate 2738, opening 2740 may be fluidiy coupled with the outlet of pump bulb 2718 such that air pumped out of pump bulb 271 S may be received through opening 2740 and transferred to vial 2716 via pressure needle 2720. hi operation, to fill a disposable housing assembly 804, a user couples the via! adapter 2732 to the main plate 2738. The vial 2716 is then coupled to the vial adapter 2732. In performing these steps (see also FIGS. I99A-199H) the transfer needle 2724 penetrates the septum of the disposable housing assembly 804 (see 199D) and also, the septum of the via! 2716 (see FiG. 199E). Thus, in various embodiments, the transfer needle 2724 does not penetrate the septum of the vial 2716 until the transfer needle 2724 also penetrates the septum of the disposable housing assembly 804. This ensures that if the via! 2716 is pressurized, the contents of the vial 2716 wilt not begin to flow until the transfer needle 2724 has penetrated the septum of the disposable housing assembly 804, thereby limiting the amtumi of wasted vial contents.

Thus, to fill a disposable housing assembly 804, the user may couple disposable housing assembly 804 in recess 2726 of main plate 2738 (e.g., including aligning disposable housing assembly 804 relative to fill adapter 2700 via openings 2728, 2730 configured to at least partially receive alignment tabs 930, 932 of disposable housing assembly 804). Disposable housing assembly 804 may be retained relative to !1Il adapter 2700 using bottom door 2742, which may pivolally close to at least partially cover recess 2726 to retain disposable housing assembly 804 at least partially within recess 2726. A user may then couple the vial adapter 2732 to the main plate 2738 and then, couple a vial 2716 to the vial adapter 2732. Coupling vial adapter 2732 to main plate 2738 may result in transfer needle 2724 penetrating the septum of disposable housing assembly 804. Additionally, coupling vial adapter 2732 to main plate 2738 may couple opening 2740 with the outlet of pump bulb 27S S. The user may then adjust turn dial 2702 (e.g., which may thereby cause movement of push plate 2704} to the desired available fill volume of reservoir 908. The user may then actuate pump bulb 2718 (e.g., by compressing and releasing pump bulb 2718). The user may continue to actuate pump bulb 2718 until no more bubbles are observed rising within via! 2716 (e.g., rising from pressure needle 2720). Additionally / alternatively, pump bulb 27 S 8 may be configured such that a single complete actuation of pump bulb 2718 may be sufficient to effect a complete transfer (e.g., the volume of air transferred from pump bulb 2718 to vial 2716 during a single actuation of pump bulb 2718 may be sufficient to produce the transfer of the maximum fill volume of reservoir 908). According to one embodiment, fill adapter 2700 may be configured to overfill reservoir 908 (e.g., to transfer a volume of fluid from via! 2716 that is at least partially greater than the available fill volume of reservoir 90S, as determined by the settings of turn dial 2702). Overfilling reservoir 908 may allow the fluid passages associated with disposable housing assembly 804 to be primed with fluid, thereby obviating the need to later prime the fluid lines of disposable housing assembly 804. Still referring to FIGS. 199A-I99H, in some embodiments, the fill adapter 2700 includes vial fingers 2744a, 2744b. As shown in FIGS. 199A-199H, as the vial 2716 is introduced to the via! adapter 2732, the vial 2716 overcomes the spring force of the vial fingers 2744a, 2744b. However, as the via! 27 S 6 reaches a end on the needle carriage 2732a, the vial fingers 2744a, 2744b return force and act to maintain the position of the via! 27! 6.

Referring now to FIGS, 200-2028, another embodiment of the fill adapter is 2750 is shown. In various embodiments of this embodiment of the fill adapter, the vial adapter 2762 includes a needle carriage 2754 which includes vial needles 2756a, 2756b and transfer needle 2756c. in some embodiments, the needles 2756a, 2756b, 2756c are 24 gauge stainless steel However, in other embodiments, the gauge of the needles may vary. In various embodiments, the gauge of needle is a balance between flexibility and efficiency. The needle carriage 2754 is slidably engaged to the interior of the via! adapter housing 2752. The vial adapter 2762 includes a check valve 27SS and a filter 2766. In some embodiments, the filter 2766 may be a .2 micron filter, or any other filter that prevents dust and other unwanted particulate matter, from entering the air iiπe and the via! (not shown). In the exemplary embodiment, the filter 2766 is a hydrophobic filter which may include any variety of gas-permeable hydrophobic materials, such as a POREX™ materia!, a GORE^{'f M} material, or the like (POREX is a trademark of Porex Corporation in the United States and/or other countries, GORE is a trade mark of W. L. Gore & Associates, Inc. in the Unites States and/or other countries). Sn some embodiments, the cheek valve 2758 is a duck bill valve. The duck bill valve serves as a check valve and a seal. However, in other embodiments, the check valve may be any type of check valve. In other embodiments, the check valve is not included and only a hydrophobic filter is used. Jn some embodiments, the hydrophobic filter my be as described above, and in these embodiments, a separate seal may also be used.

The vial adapter 2762 further includes a via! adapter housing 2752. The bousing contains the needle carriage 2754 and is adapted to removably attach to the fill adapter base 2768 by way of the receptacle 2770. The fill adapter base 2768 includes a main plate 2760 which includes the receptacle 2770. The receptacle 2770 includes at least one key, and in the exemplar}' embodiment, the receptacle 2770 includes two keys 2764b. The keys 2764b in the exemplary- embodiment, are differently sized, however, in other embodiments, they may be the same size. The different sizes of the keys 2764b allows for the vial adapter 2762 to be located in the intended orientation. The keys 2764b fit into locking features 2764a located inside the vial adapter housing 2752. Once the keys 2764b and locking features 2764a are fit together, a clockwise turn of the vial adapter 2762 locks the vial adapter 2762 to the receptacle 2770. However, in various other embodiments, the Socking features 2764a located inside the vial adapter housing 2752 may be designed such that a counterclockwise turn of the vial adapter 2762 locks the vial adapter 2 /62 to the receptacle 2770.

Locking the via! adapter 2762 to the receptacle 2770 may be desirable for many reasons, including, but not limited to, maintaining the correct orientation during fill and preventing the needles from bending or twisting during fill The locking system described above also ensures correct orientation of the vial adapter with respect to the till adapter base 2768,

Referring now to FIGS. 203A-203J, in operation, to fill a disposable bousing assembly 804, a user couples the via! adapter 2762 to the receptacle 2770. The vial adapter 2762 is then rotated clockwise, locking the vial adapter 2762 to the receptacle 2770 {see FIG. 203C). The vial 2716 is then coupled to the vial adapter 2762. In performing these steps the transfer needle 2756c penetrates the septum of the disposable housing assembly 804 (see 203E) and also, the septum of the vial 2716 (see FKJ. 203 F). Thus, in various embodiments, the transfer needle 2756c does not penetrate the septum of the vial 2716 until the transfer needle 2756c also penetrates the septum of the disposable housing assembly 804. This ensures that if the vial 2716 is pressurized, the contents of the via! 2716 will not begin to flow until the transfer needle 2756c lias penetrated the septum of the disposable housing assembly 804, thereby limiting the amount of wasted vial contents.

Thus, to fill a disposable housing assembly 804, in this embodiment, the user couples the disposable housing assembly 804 to the fill adapter base 2768 in a similar fashion as described above with respect to the fill adapter 2700. A user may then couples the vial adapter 2762 to the receptacle 2770, turns the vial adapter 2762, locking the vial adapter 2762 to the receptacle, and then, couples a vial 2716 to the vial adapter 2762. The user may then adjust the turn dial and follow similar a similar process as described above with respect to the fill adapter 2700 for filling the disposable housing assembly 804.

Referring to FIGS. 203D-203F, introducing the vial 2736 Jo the vial adapter 2762, via! fingers 2772a, 2772b, including a bent portion that grasps and holds the narrow portion of the vial 2716. However, as shown in FICr. 2031% in some embodiments, a distance remains between the top of the vial 27 !(S (i.e., the area including the septum) and the bent portion of^" the vial fingers 2772a, 2772b. As shown in FtG. 203G, to remove the via!, a user applies force to the vial 2716 in an upward direction. The upward force first pulls the vial 2716 upwards such that the needles 2756a, 2756b are no longer in contact with the contents of the vial 2716, rather, the needles 2756a. 2756b are inside the septum of the via! 2716. This ensures that if the vial 2716 is pressurized, the contents of the vial 2716 will not continue to flow while the vial 27 S 6 is being removed from the vial adapter 2756 thereby limiting the amount of wasted vial contents.

Referring to FIG. 203E, the vial adapter 2762 additional iy includes a disc 2774 (set¹ also FlG, 200). The disc 2774 remains at the bottom of the vial adapter 2762 (which may also be referred to as the receptacle end of the via! adapter 2762) until the needle carriage 2754 reaches the bottom of the via! adapter 2762. Referring to RG. 203E, the needle carriage 2754 having reached the bottom of the via! adapter 2762, the needle carriage 2754 is now connected to the disc 2774. The disc 2774 includes features which mate with the needle carriage 2754 such that, when the needle carriage 2754 moves upward, or towards the top or vial end of the vial adapter 2762, as seen in RG. 2031 S, the disc 2774 accompanies the needle carriage 2754.

Referring now to FIGS. 203I-203K, after the vial 27 ! 6 is lilted outside of the vial adapter 2762, the vial adapter 2762 may be rotated counter clockwise (RG. 203J), unlocking the vial adapter 2762 from the receptacle 2770, and the vial adapter 2762 may then be lifted off the fill adapter base 2768 (FIG. 203K). Additionally, as is shown in RG. 203 K, the needles 2756a, 2756b, 275(>c arc contained within the vial adapter 2762 thus protecting the user and others from interaction with the needles 2756a. 2756b, 2756c . Referring also to FIGS. 195A-198, another embodiment of a fill adapter (e.g., fill adapter 2800} is shown. Fill adapter 2800 may be generally similar to fill adapter 2700, including a turn dial (e.g., turn dial 2802) that may actuate a push plate (e.g., push plate 2804) for setting an available SsSi volume of reservoir 90S of disposable housing assembly 804 { FKJS. i 97- S 98). FiH adapter 2800 may also include vial adapter 2806 configured to releasably couple a via! to fill adapter 2800 for transferring fluid from the vial to reservoir 908 of disposable housing assembly 804. Fill adapter 2806 may include a pressure needle and/or a transfer needle respectively configured to introduce air into the via! and aSlow fluid to be transferred from the vial to reservoir 908 of disposable housing assembly 804. While fill adapter 2800 is shown including recess 2808 and pivoting door 2810 for retaining disposable housing assembly to fill adapter 2800, in other embodiments, the fill adapter may utilize locking features, e.g., which may releasably engage tabs 934, 936, 938, 940 disposable housing assembly 804,

With respect to the embodiments including a vial adapter removably connectable to a 111! adapter base, in some embodiments, the vial adapter may be a one-use, i.e., disposable portion, and the IIS! adapter base may be a multi-use, i.e., reusable, portion. Sn some embodiments, upon removal of the vial from the vial adapter, the needle carriage becomes locked in the end position. This may be desirable to prevent reuse and reuse may contaminate vials and disposable housing assemblies, for the transfer needle may become contaminated while stored between uses.

Fill adapter 2SO0 may include actuation button 2812, which may be disposed in turn dial 2802. Actuation button 2812 may be configured as a plunger pump, e.g., which may pump air into the vial to effectuate fluid transfer from the via! into reservoir 908, in a manner as described above. Various additional / alternative pumping mechanisms may similarly be used, as described above. Additionally, actuation button 28! 2 may operate a bias member (e.g.. spring 28 ! 4} that may limit the amount of force that is transferred to reservoir 908- For example, spring 2814 may be disposed between actuation button 2812 and the pumping member that may actually pump air into the vial As such, the force thai may be transferred to reservoir 908 may be limited to the spring force of spring 2814. As discussed above, reusable housing assembly S02 may include battery 832, e.g., which may include a rechargeable battery. Referring also to FIGS, 75-80, battery charger 1200 may be configured to recharge battery 832. Battery charger !2OO may include housing 1202 having top plate 1204. ^'Top plate 1204 may include one or more electrical contacts 1206, generally, configured to be electrically coupled to electrical contacts 834 of reusable housing assembly 802, Electrical contacts 1206 may include, but are not limited to, electrical contact pads, spring biased electrical contact members, or the like. Additionally, top plate 1204 may include alignment tabs 1208, 1210, which may be configured to mate with openings 836, S38 in base plate 818 of reusable housing assembly 802 (e.g., as shown in FlG, 35C). The cooperation of alignment tabs 1208, 1210 and openings 836, 838 may ensure that reusable housing assembly 802 is aligned with batter}' charger 1200 such that electrical contacts 1206 of batten' charger 1200 may electrically couple with electrical contacts 834 of reusable housing assembly 802. With reference also to FtGS. 77 and 78, batter}' charger 1200 may be configured Io releasably engage reusable housing assembly 802, For example, in a similar manner as disposable housing assembly 804, battery charger 1200 may include one or more locking tabs (e.g., locking tabs 1212, 1214 shown in FiG. 76}. The locking tabs (e.g., locking tabs 1212, 1214) may be engaged by labs 942, 044, 946, 948 of locking ring assembly 806, As such, reusable housing assembly 802 may be aligned with battery charger ! 200 (via alignment tabs S 208, 1210} with locking ring 806 in a first, unlocked position, as shown in FSO. 77. Locking ring 806 may be rotated relative to battery charger 1200 in the direction of arrow 1216 to reieasably engage tabs *>42, 944, 946, 948 of locking ring 806 with the locking tabs (e.g., locking tabs 1212, 1214} of battery charger 1200, as shown in FIG. 78. in an embodiment, battery charger 1200 may include recessed region Ϊ258, e.g., which may, in the exemplary embodiments, provide clearance to accommodate reusable housing assembly 802 pumping and vaiving components. Referring also to FIGS. 79 & 80, battery charger 1200 may provide electrical 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 indicative of a fully engaged reusable housing is not provided, current may not be provided to electrical contacts 1206. According to such an embodiment, the risk associated with an electrical short circuit (e.g., resulting from foreign objects contacting electrical contacts 1206) and damage to reusable housing assembly 802 (e.g., resulting from improper initial alignment between electrical contacts 1206 and electrical contacts 834) may be reduced. Additionally, battery charger 1200 may not unnecessarily draw current when battery charger is not charging reusable housing assembly 802.

Referring also to FKJS. 81-89, various embodiments of battery charger/ docking stations are shown FIGS. 8 ! and 82 depicts desktop charger 1250 including recess !252 configured to mate with and recharge a reusable housing assembly (e.g., reusable housing assembly 802). The reusable housing assembly may rest in recess 1252 &t\ύ or may be reieasably engaged in recess 1252, in a similar manner as discussed above. Additionally, desktop charger 1250 may include recess 1254 configured to mate with a remote control assembly (e.g., remote control assembly 300). Recess 1254 may include a USB plug 1256, e.g., which may be configured to couple with the remote control assembly when the remote control assembly is disposed within recess 1254. USB plug 1256 may allow for data transfer to/from the remote control assembly, as well as charging of remote control assembly. Desktop charger 1250 may also include USB port 1258 (e.g.. which may include a mini-USB port), allowing desktop charger to receive power (e.g., for charging the reusable housing assembly and/or the remote control assembly). Additionally / alternatively USB port 1258 may be configured for data transfer to / from remote control assembly and/or reusable housing assembly, e.g., by connection to a computer (not shown), Referring to FSGS. 83A-83B, similar to the previous embodiment, desktop charger

1260 may include recess 1262 for mating with a reusable housing assembly (e.g., reusable housing assembly 1264). Desktop charger may also include recess 1266 configured to receive a remote control assembly (e.g., remote control assembly 1268). One or more of recess 1262, 1266 may include electrical and/or data connections configure to charge and/or transfer data to/from reusable housing assembly 1262 and/or remote control assembly 126S, respectively.

Referring to FIGS. 84A-84B, another embodiment of a desktop charger is shown. Similar to desktop charger 1260, desktop charger 1270 may include recesses (not shown) for respectively mating with reusable housing assembly 1272 and remote control assembly 1274, As shown, desktop charger J 270 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 connection configured to charge and/or transfer data to/from reusable housing assembly 1272 and/or remote control assembly 1274, as described in various embodiments above. Referring to FIG. 85A-85D, collapsible charger 1280 may include recess 1282 for receiving reusable housing assembly 1284 and remote control assembly 1286, Collapsible charger 12S0 may include various electrical and data connection configured to charge and/or transfer data to/from reusable housing assembly 1284 and/or remote control assembly 1286, as described in various embodiments above. Additionally, as shown in FIGS. 8SB-85D, collapsible charger 1280 may include pivotable cover 1288. PivoUώle cover 1288 may be configured to pivot between an open position (e.g., as shown in PlG. 85B), in which reusable housing assembly 1284 and remote control assembly 1286 may be docked in collapsible charger 1280, and a closed position (e.g., as shown in FIG. 85D), in which recess 1282 may be covered by pivotable cover 1288. In the closed position, recess 1282, as well as any electrical and/or data connections disposed therein, may be protected from damage.

Referring to FIG. 86, wall charger 1290 may include recess 1292 configured to receive reusable housing assembly 1294. Additionally, wall charger 1290 may include 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, e.g., thereby providing a relatively slim profile. A rear portion of wall charger 1290 may include an electrical plug, configured to allow wall charger to be plugged into an electrics! receptacle. As such, wall charger S 290, whϋe plugged into the electrical receptacle, may achieve a wall mounted configuration. Additionally, while plugged into the electrical receptacle, wall charger 1290 may be provided with power for charging reusable housing assembly S 294 and/or remote control assembly 1298.

Referring to FIG. 87, wall charger ! 300 may include recess 1302 configured to receive remote control assembly 1304. Additionally, wall charger may include a recess (nut shown) configured to receive reusable housing assembly 1306. Wall charger 1300 may be configured to position remote control assembly 1304 and reusable housing assembly 1306 in a baek-Lo-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 receptacle. Electrical plug 1308 may include a stowahie configuration, in which electrical plug 1308 may be pivotable between a deployed position (e.g., as shown), and a stowed position, in the deployed position, electrical plug 1308 may be oriented to be plugged into an electrical receptacle. In the stowed position electrical plug 1308 may be disposed within recess 1310, which may protect electrical plug 1308 from damage and/or from damaging other items.

Referring to FlG. 88, charger 1320 may include recess 1322 configured to receive reusable housing assembly 1324, Charger 1320 may additionally include a recess (not shown) configured to receive remote control assembly 1326. Charger 1320 may additionally include cover 1328. Cover 1328 may be configured to pivot between an open position {as shown) and a closed position. When cover 1328 is in the open position, reusable housing assembly 1324 and remote control assembly 1326 may be accessible (e.g., allowing a user to remove / install reusable housing assembly 1324 and/or remote control assembly 1326 from / into charger 1320. When cover 1324 is in the closed position, cover 1328 and charger body 1330 may substantially enclose reusable housing assembly 1324 and/or remote control assembly 1 326 and/or recess 1322 and the recess configured Io receive remote control assembly 1326, thereby providing damage and/or tamper protection for reusable housing assembly 1324, remote control assembly 1326 and/or any electrical and/or data connection associated with charger 1320,

Referring to FIGS. 89A-89B, wall charger 1350 may include recess 1352 configured to receive remote control assembly 1354, Wall charger 1350 may also include recess 1356 configured to receive reusable housing assembly 1358. Wall charger 1350 may be configured to position remote control assembly 1354 and reusable bousing assembly 1358 in a generally side-by-side configuration, thereby providing a relatively slim profile.

Charger 1350 may additionally include electrical plug 1360, e.g., which may be configured to be plugged into an electrical receptacle. Electrical plug 1360 may include a stowabie configuration, in which electrical plug 1360 may be pivotabie between a deployed position (e.g., as shown), and a stowed position, In the deployed position, electrical plug 1360 may be oriented to be plugged into an electrical receptacle, In the stowed position electrical plug 1360 may be disposed within recess 1362, which may protect electrical plug 1308 from damage and/or from damaging other items.

Referring also to FIGS. 134 through 145, another embodiment ofa battery charger (e.g., charger 2600), which may be used to recharge battery 832 of reusable housing assembly 802, is shown. Similar to previously discussed embodiments, charger 2600 may be configured to charge both a reusable housing assembly (e.g., reusable housing assembly 802), as well as a companion remote control assembly (e.g., remote control assembly 2602). for example, charger 2600.may include reusable housing assembly charging portion 2604 configured to cooperate with reusable housing assembly 802, for the charging thereof. As shown, reusable housing assembly charging portion

2604 may include a .recess in top cover 2606 of charger 2600 that may at least partially receive reusable housing assembly 802. Jn a similar manner as discussed above, reusable housing assembly charging portion 2604 may include otie or more alignment tabs (e.g., alignment tabs 2608, 2610} that may be configured to mate with openings 836, 838 in base plate 818 of reusable housing assembly 802 (shown in FiG. 35C). The alignment of tabs 2608, 2610 and openings 836, 838 may ensure that reusable housing assembly 802 is aligned with reusable housing assembly charging portion 2604 such that electrical contacts of charger 2600 (e.g., contacts 2612) may electrically couple with electrical contacts 834 of reusable housing assembly 802.

Also, in a similar manner as discussed above, reusable housing assembly charging portion 2604 may be configured to releasably engage reusable housing assembly 802. For example, in a similar manner as disposable housing assembly 804, reusable housing assembly charging portion 2604 may include one or more locking tabs (e.g., locking tabs 2614, 2616, 2618 visible in FlG. 134), The locking tabs (e.g., locking tabs 2614, 2616, 2618) may be engaged by tabs 942, 944. 946. 948 of locking ring assembly 806. As such, reusable housing assembly 802 may be aligned with charger 2600 (via alignment tabs 260S, 2610) with locking ring 806 in a first, unlocked position, and Socking ring 806 may be rotated relative to charger 2600 in a first direction (e.g., clockwise in an exemplary embodiment) to releasably engage tabs 942, 944, 946, 948 of locking ring 806 with the locking tabs (e.g., locking tabs 2614. 2616. 2618) of charger 2600, Sn some embodiments, reusable housing assembly charging portion 2604 may include recess 2620 configured to receive locking ring nub 80S, e.g.. which may further ensure proper alignment of reusable housing assembly 802 with charger 2600. Additionally, as shown, top cover 2606 may include a recess (e.g.. recess 2622) adjacent to reusable housing assembly charging portion 2604 that may facilitate removal of reusable housing assembly 802 from charger 2600 (e.g., by allowing a user to at least partially grip reusable housing assembly 802 with a thumb or Singer). Additionally, recess 2622 may facilitates opening of lid 2626.

In addition to reusable housing assembly charging portion 2604, charger 2600 may include remote control assembly charging portion 2624, e.g., that may allow companion remote control assembly 2602 to be charged along with reusable housing assembly 802. In. the exemplary embodiment, remote control assembly charging portion 2624 is configured to receive a remote control, ϊn some embodiments, the remote control may include a glucose strip reader on portion of the remote control intended to be placed into remote control assembly charging portion 2624. In these embodiments, remote control assembly charging portion 2624 may accepts the remote control during charging such that the strip reader may be blocked by remote control assembly charging portion 2624. This may be desirable to prevent a user from using the glucose strip reader while the remote control is on the charger. Remote control assembly charging portion 2624 may include a recess configured to receive at least a portion of remote control assembly 2602. Charger 2600 may include lid 2626, e.g., which may be adjacent to, and/or at least partially define, remote control assembly charging portion. For example, lid 2626 may, in an open position, extend generally upwardly relative io top cover 2606. Further, lid 2626 may include surface 2628 that may be at least generally aligned with remote control assembly charging portion 2624. As such, lid 2626 may facilitate insertion of remote control assembly 2602 into remote control assembly charging portion 2624 (e.g., by allowing remote control assembly to generally slide downwardly along surface 2628 and into remote control assembly charging portion 2624). Additionally, lid 2626 may support remote control assembly 2602 while coupled in remote control assembly charging portion 2624 (e.g., to reduce stress imparted on remote control assembly 2602 from being bumped, etc., from being transferred to electrical connection or the like associated with remote control assembly charging portion 2624}.

With particular reference also to FIGS. 136-137, charger 2600 may include lock cover 2630, e.g., which may at least partially conceal and/or protect reusable bousing assembly charging portion 2604 when not in use (e.g., when a reusable housing assembly is not being charged or stored on charger 2600). In a similar manner to reusable housing assembly 802, lock cover 2630 may include one or more locking tabs that may interact with the locking tabs of charger 2600 (e.g.. locking tabs 2614, 2616, 26! S) to allow reieasable engagement of lock cover 2630 with reusable housing assembly charging portion 2604. As shown in FlG. 137, lock cover 2630 may provide protection for / concealment of reusable housing assembly charging portion 2604. e.g.., without impeding access to and/or the use of remote control assembly charging portion 2624. As such, reusable housing assembly charging portion 2604 may be protected / concealed while still allowing remote control assembly 2602 to be charged by / reside in charger 2600. Further, while not shown, when neither reusable housing assembly charging portion 2604 nor remote control assembly charging portion 2624 are in use, Wd 2626 may be pivoted to a closed position, e.g., disposed over both reusable housing assembly charging portion 2604 and remote control assembly charging portion 2624. As such, in the closed position lid 2626 may provide protection for charger 2600 when charger 2600 is not in use.

Referring also to FiGS. 139-145, charger 2600 is shown in various exploded, and partially exploded views. As shown, Hd 2626 may include integrated shaft portions 2632, 2634 that may be at least partially received in cooperating recesses in the rear of top cover 2606 (FlG. 140). Primed circuit board 2636, including the various electronics associated with charger 2600, may be mounted to the rear or top cover 2606, e.g., using screws, heat- staked posts, or other suitable fastening means (FIG. S 41 ). Lid closure features 2638, 2640 may bo received in top cover 2606 at least partially engaging shall portions 2632, 2634. Bias members 2642, 2644 may bias lid closure features 2638, 2640 into engagement with shaft portions 2632, 2634 ( FIG. 142). Bias members 2642, 2644 may include a resilient material, such as silicone, rubber, or the like, and / or may include springs or other biasing structures. In one embodiment, shaft portions 2632. 2634 may include features (e.g.. flatted regions, etc.) that may interact with lid closure features 2638, 2640 when Hd 2626 is in, or close to. a fully open and/or a fully closed position. ^'The interaction between lid closure features 2638, 2640 and shaft portions 2632, 2634 may bias Hd 2626 to the fully open and/or the fully closed position.

Intermediate tray 2646 may be secured to top cover 2606 via plate 2648, which may itself be secured io top cover 2606 using screws, heat-stake posts, adhesive, or other suitable fastening means (FlG. 143). Intermediate tray 2646 may include a recess at least partially defining the remote control assembly charging portion 2624 of charger 2600. Additionally, intermediate tray 2646 may include opening 2650 configured to at least partially receive electrical connector 2652 coupled to printed circuit board 2636 (e.g., capable of establishing an electrical connection between charger 2600 and remote control assembly 2602). Plate 2648 may include, for example, a stamped metal plate. Additionally, plate 2648 may increase the weight of charger 2600, which may allow charger 2600 to resist tipping ami/or facilitate one handed installation / removal of reusable housing assembly 802 on charger 2600. For example, the weight added by plate 2648 may allow charger to be tilted rcarwardly between about 15-30 degrees without tipping over. The degree of rearward tilt achievable before charger 2600 tips over may vary depending upon, for example, the weight of plate 2648, weight distribution, center of gravity, and the like, and may be varied according to design criteria.

Bottom cover 2654 may be coupled to top cover 2606 and/or intermediate tray 2646 via suitable fastening means, including, but not limited to, screws that may be secured to one or more of plate 2648, top cover 2606, and/or intermediate tray 2646. Sn an embodiment in which bottom cover 2654 may be coupled via screws, foot pads 2656, 2658 may be disposed over the screws and/or screw recesses of bottom cover 2654 (FiGS. 144- 1451 Additionally, foot pads 2656, 2658 may include a relatively high friction material (e.g., uretliane foam or elastomer, rubber, or the like) that may increase the slip resistance of charger 2600 relative to a surface upon which charger 2600 is disposed. Further, bottom cover 2654 may include opening 2660 that may allow access to reset buiton 2662, e.g., which may be disposed on printed circuit board 2636.

According to one embodiment, charger 2600 may utilize a mini-USB connection, e.g., which may provide power Io charger 2600 as well as allowing data communication, e.g., between charger 2600 and an external computer (such as a persona! computer, or the like). In some embodiments, charger 2600 may utilize a modified mini-USB connection, e.g., which may have the square table of the mini-liSB-A plug removed to facilitate extraction of the plug from charger 2600. Accordingly, charger 2600 may allow for the charging of batteries associated with reusable housing assembly 802 and / or remote control assembly 2602, as well as communication between remote control assembly 2602, reusable housing assembly 802, and an externa! computer. Such communication may allow for, for example, downloading of logs from reusable housing assembly 802 (e.g., which may be transmitted via the internet, or other communication network, to a customer support service), reprogramming (e.g., upgrading software, conducting diagnostics, changing program attributes, etc. ) of reusable housing assembly 802 and/ or remote control assembly 2602,

Charger 2600 may include one or more status indicators (such as LEDs) that may indicate a charging status (e.g., charging in process, charging complete), as well as one or more fault conditions. For example, a red and a green LED may be utilized in connection with one or both of reusable housing assembly 802 and remote control assembly 2602. The red and green LED may be visually perceptible through top cover 2606 of charger, via a thinned region of top cover 2606, one or more openings in top cover 2606, or the like. For example, hi one embodiment, a continuously glowing red LED may indicate that the reusable housing assembly is currently being charged. A continuously glowing green LED may indicate that the reusable housing assembly is completely charged. A blinking red LED may indicate a lault condition that may require user intervention. In addition to the blinking red LED, in some embodiments, the exact nature of the fault condition may be displayed on a display screen associated with the remote control assembly. The absence of the red and the green LED being illuminated may indicate that no device is coupled (or is not properly coupled) to charger 2600. Various additional / alternative status indicator arrangements may he implemented depending upon design criteria and user preference. In some embodiments, charger 2600 may include one LED as a status indicator for reusable housing assembly S02 and remote control assembly 2602 may itself indicate status via a screen of/ associated with remote control assembly 2602 or other status indicators OH remote controi assembly 2602, Such other status indicators may include, but are note limited to, alarms (e.g., audio and/or vibration) and/or one or more LEDs.

In addition to the status indicators, which may indicate charging status and the occurrence of a fault condition, charger 2600 may include one or more overvoltage protection circuitry', in an embodiment, charger 2600 may include input overvoltage protection circuitry, which may actuate (e.g., via opening the circuit, etc.) in the event that the voltage provided by the USB connection is greater than a predetermined threshold. Additionally / alternatively, charger 2600 may include output overvoltage protection circuitry, which may actuate (e.g., via opening the circuit, etc.} In the event that the voltage provide to the reusable housing assembly and/or the remote controi assembly is greater than a predetermined threshold. Additionally, the battery of the reusable housing assembly and/or of the remote control assembly may include an overvoltage protection, e.g., which may prevent battery damage resulting from an overvoltage event at the battery, which may not be prevented by either the input overvoltage protection circuitry or the output overvoltage protection circuitry. According to an embodiment, the overvoltage protection circuitry may be hardware based, i.e., may not rεly upon software. As such, the overvoltage protection circuitry may provide a higher level of safety, as it may not be subject to software faults. Additionally, according to one embodiment, the occurrence of an overvoltage event may trigger a fault condition indicator {e.g., a blinking LED, or the like).

As shown, e.g., in FIG. S 34, charger 2600 may utilize a six contact electrical connector (e.g., electrical contacts 2612). According to an embodiment, the six contact electrical connector may allow for power transfer between charger 2600 and reusable housing assembly 802. Additionally, the six contact electrical connector may allow connection between a batiery thermister and charging circuitry (e.g., which may allow charging to be discontinued and/ or provide a fault condition indication in the event that the battery temperature is out of range}. Further, the six contact electrical connector may- provide for two-way communication between reusable housing assembly 802 and charger 2600 (as well as between reusable housing assembly 802 and an external computer via charger 2600). The two-way communication may allow for, for example, reprogramming of reusable housing assembly 802 (e.g., to upgrade software}, obtaining data from reusable housing assembly 802 (e.g., such as log Information to be sent to customer sen-ice center), or the like. ^"Hie six contact electrical connector may also allow .reusable housing assembly 802 (e.g., circuitry within the reusable housing assembly) to be reset, either as a result of a reset signal originating from an external computer, or as a result of reset button 2662 being actuated. Resetting reusable housing assembly 802 may be utilized for certain functions, such as programming reusable housing assembly, diagnostic purposes, resetting a malfunctioning reusable housing assembly, or the like. Additionally, the six contact electrical connector may allow charger 2600 to recognize that a reusable housing assembly has been coupled to charger 2600. Similarly, the six contact electrical connector may allow reusable housing assembly 802 to recognize that it has been coupled to charger 2600. The ability of reusable housing assembly 802 io recognize thai it has been coupled to charger 2600 may allow, for example, reusable housing assembly 802 to enter a low power state while charger, initiate download of logs, or the like. While the various features of the electrical connection between charger 2600 and reusable housing assembly 802 have been described, it will be appreciated that similar electrical connections may be utilized between charger 2600 and remote control assembly 2602. Additionally, while the use of a six contact electrical connector has been discussed, this is for exemplary purposes only, as the number and nature of electrical contacts and associated features may van-' depending upon user need and design criteria.

According to one embodiment, the electronics of charger 2600 may include a commercially available charging circuit, such as a model L6924D Battery Charger System with Integrated Power Switch for U-Ion/Li-Polymer (detailed in Appendix A), available from STlVlicroeleetramcs of Geneva, Switzerland. Various other battery charging circuits may be utilized depending upon, for example, battery characteristics, design criteria, or the like. Hie battery charging circuit may. for example, monitor battery voltage and temperature (e.g., via information provided by the battery theroiister via the six contact electrical connector). Additionally, the battery charging circuit may adjust the battery charging parameters based upon, for example, the battery voltage, battery temperature, predetermined charging requirements (e.g., desired charge time, etc) or the like.

In addition to the charging circuit, the electronics of charger 2600 may additionally include one or more processors (example of which may include, but is not limited to an MSP430 microcontroller, available from Texas instruments inc. of Dallas, Texas) that may control charger 2600, as well as provide for communication between an external computer and reusable housing assembly 802 and/or remote control assembly 2602. The one or more microprocessors may control the overall operation of charger 2600. For example, the microprocessor may allow communication between reusable housing assembly 802 and an external computer. Similarly, the microprocessor may control the operation of the status indicators (e.g., the LBDs), Various additional / alternative operations and features of charger 2600 may be controlled by the microprocessor. Referring also to FIGS, 146-148, exemplary charger circuitry that may be utilized in connection with charger 2600 is schematically illustrated. The illustrated charger circuitry is intended of illustrative purposes only, as the exact configuration may vary depending upon included features (status indicators, overvoitage protection, and the like), as well the charging circuit and microcontroller utilized. Referring also to FIGS. J 49-173 various features and embodiments of chargers that may be utilized in connection with the reusable housing assembly and/or remote control assembly are depicted. Any of the depicted chargers may incorporate one or more of she above-described features.

Infusion pump therapy may include volume and time specifications. The amount of fluid dispensed together with the dispense timing may be two critical factors of infusion pump therapy. As discussed in detail below, the infusion pump apparatus and systems described herein may provide for a method of dispensing fluid together with & device, system and method for measuring the amount of fluid dispensed. However, in a circumstance where the calibration and precision of the measurement device calibration is critical, there may be advantages to determining any compromise in the precision of the measurement device as soon as possible. Thus, there are advantages to off-board verification of volume and pumping.

As discussed above, infusion pump assembly 100 may include volume sensor assembly 148 configured to monitor the amount of fluid infused by infusion pump assembly 100. Further and as discussed above, infusion pump assembly J00 may be configured so that the volume measurements produced by volume sensor assembly 148 may be used to control through a feedback loop, the amount of infusible fluid that is infused into the user.

Referring also to FICJS. 90Λ-90C, there is shown one diagrammatic view and two cross-sectional views of volume sensor assembly 148. Referring also to FIGS. Η A-91 [, there is shown various isometric and diagrammatic views of volume sensor assembly 148 (which is shown to include upper housing 1400). Referring also to FlGS. 92A-921, there is shown various isometric and diagrammatic views of volume sensor assembly 148 (with upper bousing 1400 removed), exposing speaker assembly 622, reference microphone 626, and printed circuit board assembly 830 Referring also to FIGS 93 A-93I, there is shown vaπous isometric and diagrammatic views of volume sensor assembly 148 (with pπnted circuit board assembly 830 removed), exposing port assembly 624 Referring also to FIGS 94A-94F, there is shown vaπous isometric and diagrammatic cross-sectional views of volume sensor assembly 148 (with printed circuit board assembly 830 removed), exposing port assembly 624 Referring also to FIG 95, there are shown an exploded view of volume sensor assembly 148, exposing upper housing 1400, speaker assembly 622, reference microphone 626, seal assembly 1404, lower housing 1402, port assembly 624, spπng diaphragm 628, and retaining πng assembly 1406

The following discussion concerns the design and operation of volume sensor assembly 148 (which is shown in a simplified form in FIG 96) For the following discussion, the following nomenclature may be used

DERIVATION OF THE EQUATIONS FOR VOLUME SENSOR ASSEMBLY 148: Modeling the Acoustic Volumes

The pressure and volume of an ideal adiabatic gas may be related by

PV = K [EQ#1] where £ is a constant defined by the initial conditions of the system

84 EQ#1 may be written in terms of a mean pressure, P, and volume, V, and a small time-dependent perturbation on top of those pressures, p(t) , v(t) as follows:

(P + p(t))(V + v(t)J = K [EQ#_]

Differentiating this equation may result in: P{t)(V + v(t))^r +γ{V + v(t))^γ-' (P+ p{t))v(t) = 0 IECWJ which may simplify to:

How good is this assumption? Using the adiabatic relation it may be shown that:

[EMfβi

Accordingly, the error in the assumption would be:

where p_nf = 20 μPa .

Applying the ideal gas law, P = pRT , and substituting in for pressure may result in the following:

EQ#9 may be written in terms of the speed of sound, a = -jγRT as follows:

85

Acoustic impedance for a volume may be defined as follows:

Modeling the Acoustic Port

F = fpA²x _|EQ#12)

A second order differential equation may then be written for the dynamics of the fluid in the channel:

PLAx = ApA - fpA²x _|EQ#13] or, in terms of volume flow rate:

ZA . A v = -- — v + Ap

^L P^L [E(WU]

The acoustic impedance of the channel may then be written as follows:

v A V L ) _|EQ#15]

System Transfer Functions

° |EQ*16]

86

P -O

² |EQ#18]

/A A , s

^L P^L |EQ#19]

One equation may be eliminated if po is treated as the input substituting in V₁ = ^• Ys. Po pa¹ x V V

¹ I |EQ#20]

P f₂l ₊^ y v r = O

² |EQ#21]

Cross System Transfer Function

P_{2 =} K <

P₀ V_{ι S} ² +2ζω_ns + aω> _|EQ#a] where

Referπng also to FIG 97, a bode plot of EQ#23 is shown The difficulty of this relationship is that the complex poles depend on both the vanable volume, Fj, and the reference volume, Vi Any change in the mean position of the speaker may result in an error in the estimated volume

Cross Port Transfer Function

The relationship between the two volumes on each side of the acoustic port may be referred to as the Cross Port transfer function This relationship is as follows

87 P₂ _ <»»

P₁ s² +2ζω_ns + ω_n ² _lEaas] which is shown graphically in FIG. 98.

Cross Speaker Transfer Function

P_{1 =} V₀ s² + 2ζω_as + ω_n ²

P₀ V_x s² +2ζω_ns ₊ aωl _[EQm] which is shown graphically in FIG. 99. This transfer function has a set of complex zeros in addition to the set of complex poles.

Looking at the limits of this transfer function: as s — > 0 , — — > — ; and as

Po K + ^V2

A_→_ϋ

Resonance Q Factor and Peak Response

|EQ#2β]

This may occur at the damped natural frequency:

|EQ#29]

Volume Estimation

Volume Estimation using Cross-Port Phase

At the 90° phase point, ω = ω_n ; where =

The resonant frequency may be found on the physical system using a number of methods. A phase-lock loop may be employed to find the 90° phase point — this frequency may correspond to the natural frequency of the system. Alternatively, the resonant frequency may be calculated using the phase at any two frequencies: The phase, φ , at any given frequency will satisfy the following relation:

, , bω

Lαii J

|EQ#31] where * = ^- .

Solving for V₁ results in: a²A

L

V₁ - ω^z -fωcotφ |EQ#32] Accordingly, the ratio of the phases at two different frequencies (O₁ and O₂ can be used to compute the natural frequency of the system:

For computational efficiency, the actual phase does not need to be calculated. All that is needed is the ratio of the real and imaginary parts of the response ( tan φ ).

89 Re-writing EQ#33 in terms of the variable volume results in:

The transfer function for the system may be expressed as a rational function of s. The general case is expressed below for a transfer function with an «'* order numerator and an m'^h order denominator. A^ and D are the coefficients for the numerator and denominator respectively. The equation has been normalized such that the leading coefficient in the denominator is 1. l +...+ N_n

0(S) - . "S ⁺"^

^ ⁺ A,,-,* + ^D _m-2* +-+ ^D0 [EQ#35] or

∑V

G(s) = -

*=° [EQ#36]

This equation may be re-written as follows:

Gs" = ∑N_ts^k -G∑D^ i-o *-o [ECW37]

Representing this summation in matrix notation resulting in the following:

90 where k is the number of data points collected in the swept sine. To simplify the notation, this equation may be summarized using the vectors: y = ^XC |EQ*39] where y is k by 1 , x is k by (m+n- 1 ) and c is (m+n- 1 ) by 1. The coefficients may then be found using a least square approach. The error function may be written as follows: e = y-^XC IECW40]

The function to be minimized is the weighted square of the error function; W is a k x k diagonal matrix. e^TWe = { ^ y - Xcf / W (Vy - Xc) I [ECW41] e^TWe = y^TWy- (y^TWXc)^T - y^TWXc + c^Tx^TWXc ' ' V l ' |EQ#42]

As the center two terms are scalars, the transpose may be neglected. e^TWe = y^TWy-2y^TWXc+c^Tx^TWXc _IPO-ωl de^TWe

- = -2X^TWy + 2X¹ WXc = 0 dc [EQ#44] c = [X⁷WX) '^'"1' X A"¹W Wyv

[EQ#4S] It may be necessary to use the complex transpose in all of these cases. This approach may result in complex coefficients, but the process may be modified to ensure that all the coefficients are real. The least-square minimization may be modified to give only real coefficients if the error function is changed to be e^TWe = Rc(y-Xc)^T WRe(y-Xc) + \m(y- Xc)^T W \m(y-Xc) _|EQ#46] Accordingly, the coefficients may be found with the relation:

C = IRS(X)^T WRe(X) + ]m(xf W hn(X)Ϋ (RS(X)^T WRe(y)+ lm(xf Whn(y))

[EQ#47]

G(s) =

^ + D₁S ₊ D_{0 |EQM8]}

91 c = (Re(X)^r W Re(X) + M(xf w Im(X)J (Re(A')^r »^rRe(>)+Iin(A')^r »^rIπi(^))

[EQ#49] where:

To simplify the algorithm, we may combine some of terms:

C = D 2> |EQ#51] where:

b = Rc(xf WRe(y) + 1m(X)^T Whn(_y) ^^

To find an expression for D in terms of the complex response vector G and the natural frequency s =ja>, Xmay be split into its real and imaginary parts:

1 ω_k Im(G₁ ) -Re(G₁ ) 0 -^ Re(G₁ ) -Im(G₁ )

Re(X) = Im(X) = 1 ω_t Im(G₄ ) -Re(G₄ ) 0 -ω_k Re(G_j ) -Im(Gj

[EQ#54]

The real and imaginary portions of the expression for D above may then become:

Σ". ∑w, Im(G₁ )ω_t -Xw₁ Re(G₁)

Re(X)^r WRe(X) = ∑ w, Im(G, )ω, ∑ w, Im(G, )² ω] -∑ w, Im(G, ) Re(G, )ω,

-∑ w, Re(G, ) -∑ w, Im(G₁ ) Re(G, )ω, ∑ ^w. ^Re(^G. )²

[EQ#55]

Im(X)^r WIm(X) = 0 ∑ w, Re(G, )² ω,² ∑ w> Im(G, ) Re(G, )ω,

0 Xw₁ Im(G₁)Re(G₁)O₁ Xw₁ Im(G₁)²

|EQ#56]

92 ∑w. ]T w, Im(G, )ω, -∑ w, Re(G,)

D = w, Im(G, )<y, ∑ w, (Re(G, )² + Im(G, f )ωf 0

-∑ W₁ Re(G₁) 0 ∑ w, (Re(G,)² + Im(G,)²)

[EQ#57]

The next step is to invert the D matrix. The matrix is symmetric and positive- definite so the number of computations needed to find the inverse will be reduced from the general 3x3 _case χh_e general expression for a matrix inverse is:

IfD is expressed as follows:

then the adjugate matrix may be written as follows:

93 Due to symmetry, only the upper diagonal matrix may need to be calculated. The Determinant may then be computed in terms of the adjugate matrix values, taking advantage of the zero elements in the original array: tet(D) = a_nd_n + Q₁₁(I₁₁ [EQ#63]

Finally, the inverse of D may be written as follows:

1

Z) ¹ = - adj(D) detφ) |EQ#64]

Since we are trying to solve: c = D-'b = adj(D)b det(D) |EQ#65] then:

The final step is to get a quantitative assessment of how well the data fits the model. Accordingly, the original expression for the error is as follows: e^τ We = Re(y- Xc f W Re(y-Xc) + \m(y- Xc)^τ W \m{y - Xc)

{EQ#67]

This may be expressed in terms of the D matrix and the b and c vectors as follows: e^TWe = h-2c^Tb+c^TDc [EQ#68] where: λ = Re(/)WRe(.y)+ Im(/)W Im(.y)

|EQ#69] A = ∑w, (Re(G,)² + lm(G,)² )ω?

|EQ#70]

The model fit error may also be used to detect sensor failures.

Alternate Solution for a 2nd Order System

N_ns" + N_^1S"^'1 +...+ N₀

G(s) = s^m +D_^,s"' ' +O_ ^! +...+D_n or

G(s) =

>-+∑v

94 This equation may be re-written as follows:

¹⁼⁰ *=° [EQ#73]

Putting this summation into matrix notation results in the following:

D_n

[EQ»74]

G(s) = % s² +D₁S ₊ D_{0 |EQ#75]} The coefficients in this transfer function may be found based on the expression found in the previous section: c =

WRe(X) + lm(X)^T WM(X)J' (Re(Xf WRe(y) + hn(X)^T W]m(yj}

[EQ#7β] where

To simplify the algorithm, some terms may be combined: c = D^''b _|EQ#78] where:

D = Re(Xf WRe(X)₊Im(Xf WIm(X) _ιEQøτgy b = Re(Xf WRe(y) + lm(xf Wlm(y) I ttiff BUJ

To find an expression for D in terms of the complex response vector C and the natural frequency s =jω, split X may be split into its real and imaginary parts:

95 0 -U)₁-¹Re(G,) U)-²Im(G₁)

Im(A') = 0 -ω?Re(G_t) V Im(G₄)

|EQ#82]

The real and imaginary portions of the expression for D above may then become.

Re(Xf WRe(X)

[EG#83]

Im(X)⁷WIm(X) = 0 Xw₁Re(G₁)²V -Xw₁Im(G₁)Re(G₁)V

0 -Xw₁Im(G₁)Re(G₁)V Xw₁Im(G₁)²V

[EQ#β4]

Xw₁Im(G₁)V -Xw₁Re(G₁)V

D = Xw₁Im(G₁)V ∑w, (Re(G,)² +Im(G₁)²) V -2Xw₁Im(G₁)Re(G₁)V

-Xw₁Re(G₁)V -2Xw₁Im(G₁)Re(G₁)V X^₁ (Re(G₁)² +Im(G₁)²) V

[EQ*85]

96 b = Re(X)^T WRe(y) + lm(X)^T W\m{y)

Implementing Acoustic Volume Sensing

Collecting the Frequency Response Data and Computing the Complex Response

To implement volume sensor assembly 148, volume sensor assembly 148 should determine the relative response of reference microphone 626 and invariable volume microphone 630 to the acoustic wave set up by speaker assembly 622. This may be accomplished by driving speaker assembly 622 with a sinusoidal output at a known frequency; the complex response of microphones 626, 630 may then be found at that driving frequency. Finally, the relative response of microphones 626, 630 may be found and corrected for alternating sampling by e.g., an analog-to-digital converter (i.e., ADC).

Additionally, the total signal variance may be computed and compared to the variance of pure tone extracted using the discrete Fourier transform (i.e., DFT). This may result in a measure of how much of the signal power comes from noise sources or distortion. This value may then be used to reject and repeat bad measurements.

Computing the Discrete Fourier Transform

2 N-I

[EQ*88]

97 The product MN may be the total number of points and the factor of two may be added such that the resulting real and imaginary portions of the answer match the amplitude of the sine wave

This real part of this expression may be as follows

. 2 fc! (2π λ re(x) = > x cos — n

MNiA U J ₁ |EQ#90]

_{/ Λ} 2 [/ \ *£' (π 2π V/ \ / \1 re(x) = ( X_n - ^iV + / ^sln " I * ~ ^χiv ] -\ Xiv ~^χκ I

MV p ' ' Tl \ 2 N JLV ^iN*" ' V !^N+" /J

Similarly, for the im maaggminaarryy ppoorrttiioonn ooff tthhee eeqquuaattion

2 « (2π \ n(x) = > x sin — n

MN h " V N J |EQ#92) which may be expr reesssseedd aass ffoolllloowwss

The variance of this signal may be calculated as follows

Computing the Signal Variance

N-I /N-I Y

"=° ^"=° ' |EQ#95]

The result may be in the units of AD counts squared It may only be the "pseudo- variance" because the signal has been averaged over M periods before the variance is calculated over the Λ' samples in the "averaged" peπod This may be a useful metπc,

98 however, for finding if the "averaged" signal looks like a sinusoid at the expected frequency This may be done by comparing the total signal variance to that of the sinusoid found in the discrete Fouπer transform

N-I

The summation may be on the order of ∑x² = 0[NM²I") for a 12-bit ADC If

N < 2⁷ = 128 and M < 2⁶ = 64 , then the summation will be less than 2⁴¹ and may be stored in a 64-bit integer The maximum possible value of the variance may result if the ADC oscillated between a value of 0 and 2¹² on each consecutive sample This may result in a peak variance of — (2¹² ) = 2²² so the result may be stored at a maximum of a 1/2'

4 resolution in a signed 32-bit integer

Computing the Relative Microphone Response

G = ^•V/

•V ^•V -V/ |EQ#96]

_9flrλ M^x.)^ReQv) ^{+ lm}(O^lm(_V)

^ ' ^{" '}/ \2 ? \* **('« ) ^*"' ) ,ECW₉T]

Re(_V)² + Im(_V)² = 2< _iEQ#99]

Correcting for A/D Skew

99

Reference Models

Second and Higher Order Models

A+^-(*. -*,»)=o

|EQ#101]

L₁₂ PL₁₂ |EQ#103]

Putting these equations into state-space results in the following:

100 (Q\₂ (s² + b₂^s + ω₂\)

Λ (s² +b₁₂s + af₂)(s² +b₂,s + ω₂ ²,)+-÷ω₂ ², (s + b_i2)s

² |EQ#107]

Expanding the denominator results in the following

A bubble underneath the diaphragm matenal in the vaπable volume will follow the same dynamic equations as a leakage path In this case, the diaphragm matenal may act as the resonant mass rather than the leakage port Accordingly, the equation may be as follows mx = ApA -b_mx _|EQ#109] wherein m is the mass of the diaphragm, A is the cross sectional area of the diaphragm that can resonate, and b_m is the mechanical damping EQ#106 may be written in terms of the volume flow rate

wherein the volume of the air bubble is V3 If the bubble volume is substantially smaller than the acoustic volume V3 « V2 than the transfer function may be simplified to

Second Order with Time Delay

A time delay may be expressed in the Laplace domain as

G(s) = e |EQ#112]

101 which makes for a non-linear set of equations. However, a first-order Pade approximation of the time delay may be used as follows:

G(s) = ψ s

^Δ~ |EQ#113] which is shown graphically in FIG, 102,

Three Chamber Volume Estimation

² [EQ#115]

*,., = -^⁵J⁴H₁₂ +^(A -Λ) p^Lπ [EQ#116]

^^{1 P} " [EQ#11β]

where

».

P-

Pi s +2ζ,,ω_at,_S + ω,,_{n |£Q#121]} where

102

The volume of volume sensor chamber 620 may be estimated using the ratio of the natural frequency of the two resonant ports as follows

Exponential Volume Model

Assume the flow out through the flow resistance has the following form

τ [EQ#124]

Assuming a fixed input flow rate from the pump chamber, the volume of volume sensor chamber 620 is based upon the following differential equation

τ |EQ#125] which gives the following solution assuming a zero initial volume

Accordingly, the output flow rate flows

The volume delivered during the pump phase may be wπtten

V_^ = KA t- τ\ l -e _{( |}

|EQ#128)

Device Calibration

The model fit 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

103 relationship between the resonant frequency and the delivered volume to be expressed as follows:

₂ O¹A 1 cor =

^{L Vl} |EO#129]

The speed of sound will vary with temperature, so it may be useful to split out the temperature effects. ω 2 = - YRΛ T

I V ² [EQ#130]

The volume may then be expressed as a function of the measured resonant frequency and the temperature:

T V - C— ω" [ECW131] vRA Where c is the calibration constant C = - —

Implementation Details End Effects

V

X = pa¹ A ' [EQ#132] If we assume the following values:

F = 28.8xlO^→L _|EQ#133]

a = 340-a |EQ#135J d = 0.5 mm _|EQ_#I₃₆] P = I -Pa (Approximately 100 dB) [EQ#137]

Accordingly, the air will extend roughly 1.9 mm in to the acoustic chamber.

Sizing Vl (i.e., the fixed volume) relative to V2 (i.e., the variable volume)

104 Sizing V_\ (e.g., fixed volume 1500) may require trading off acoustic volume with the relative position of the poles and zeros in the transfer function. The transfer function for both V_\ and V₂ (e.g., variable volume 1502) are shown below relative to the volume displacement of speaker assembly 622.

Jh. = . pa 2

< v, s² + 2ζω_ns + aωl [EQ#138] h pά '^■ s² +2ζω_πs + aω_π ² vk V_x s^ι +2ζω_ns + ωl |EQ#139] where

1

CU — ^fΛ a -[\

" L ζ = ^■

V₂ ^1Lω- and I Vj |EQ#140]

As V_\ is increased the gain may decrease and the speaker may be driven at a higher amplitude to get the same sound pressure level. However, increasing V₁ may also have the benefit of moving the complex zeros in the pi transfer function toward the complex poles. In the limiting case where V₁ -> ∞ , a → 1 and you have pole-zero cancellation and a flat response. Increasing V_\, therefore, may have the benefit of reducing both the resonance and the notch in thepi transfer function, and moving thep2 poles toward ω_n ; resulting in a lower sensitivity to measurement error when calculating the pilp_\ transfer function. FIG. 104 is a graphical representation of: ϋ

^V* |EQ*141]

FIG. 105 is a graphical representation of

EL

^V* |EQ#142] Aliasing

where f_s is the sampling frequency, /„ is the frequency of the noise source, n is a positive integer, and/ is the aliased frequency of the noise source.

The demodulation routine may effectively filter out noise except at the specific frequency of the demodulation. If the sample frequency is set dynamically to be a fixed

105 multiple of the demodulation frequency, then the frequency of the noise that can alias down to the demodulation frequency may be a fixed set of harmonics of that fundamental frequency.

where /? = — = 8. For β = 16 , the following series would result:

_|EQ#U5]

Performance

Sensitivity to Temperature

^' r, T,

^{Vl ~} >l $, _|EQ#147] Accordingly, if the same temperature is used for both sine sweeps, any error in the temperature measurement may look like a gain change to the system.

71

<w =i-_r aaual [EQ#148]

"""^" M¹ |EQ#149]

Accordingly, if the measurement varies by 0.1 K during the two measurement sine sweeps, the difference may be 0.012 uL. Therefore, it may be better to use a consistent

106 temperature estimate for each delivery rather than taking a separate temperature measurement for each sine sweep (as shown in FIG 107)

^∑ ~ ^l |EQ#150]

A discrete-time PI regulator may perform according to the following

G_e(z) = K, (l +£-?-)

^P \ T 7 - 1

^ '< ^{Z 1}J |EQ#151]

The AVS system described above works by comparing the acoustic response in fixed volume 1500 and vaπable volume 1502 to a speaker driven input and extracting the volume of the vaπable volume 1502 As such, there is a microphone in contact with each of these separate volumes (e g , microphones 626, 630) The response of vaπable volume microphone 630 may also be used in a more gross manner to detect the presence or absence of disposable housing assembly 114 Specifically, if disposable housing assembly 114 is not attached to (i e , positioned proximate) vaπable volume 1502, essentially no acoustic response to the speaker dπven input should be sensed The response of fixed volume 1500, however, should remain tied to the speaker input Thus, the microphone data may be used to determine whether disposable housing assembly 114 by simply ensuπng that both microphones exhibit an acoustic response In the event that microphone 626 (i e , the microphone positioned proximate fixed volume 1500) exhibits an acoustic response and microphone 630 (i e , the microphone positioned proximate vaπable volume 1502) does not exhibit an acoustic response, it may be reasonably concluded that disposable housing assembly 114 is not attached to reusable housing assembly 102 It should be noted that a failure of vaπable volume microphone 630 may also appear to be indicative of disposable housing assembly 114 not being attached, as the failure of vaπable volume microphone 630

107 may result in a mid-range reading that is nearly indistinguishable from the microphone response expected when disposable housing assembly 1 14 is not attached.

For the following discussion, the following nomenclature may be used:

σmax = ^ »««(/) |EQ#152]

[EOJ154]

While δ may be divided by the number of sine sweeps to get the average minimum / maximum difference for the sine sweep (which is then compared to a threshold), the threshold may equivalently be multiplied by N for computational efficiency. Accordingly, the basic disposable detection algorithm may be defined as follows: T

T & δ_ref > N * T

|EQ#155]

108 The additional condition that the maximum / minimum difference be greater than the threshold is a check performed to ensure that a failed speaker is not the cause of the acoustic response received. This algorithm may be repeated for any sine-sweep, thus allowing a detachment of disposable housing assembly 114 to be sensed within e.g., at most two consecutive sweeps (i.e., in the worst case scenario in which disposable housing assembly 114 is removed during the second half of an in-progress sine sweep).

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

The natural frequency of volume sensor assembly 148 may be measured in a number of different ways. For example, a time-varying force may be applied to the diaphragm (not

109 shown) and the relationship between that force and the motion of the diaphragm (not shown) may be used to estimate the natural frequency of volume sensor assembly 148. Alternately 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.

110 The force applied to the resonant mass (not shown) may be accomplished in various ways, examples of which may include but are not limited to

• measuring the pressure in the fixed volume,

• the resonant mass (not shown) may be a piezoelectric material, and

• via piezoelectric sensor,

• via capacitive sensor,

• via optical sensor,

• via Hall-effect sensor,

• via a potentiometer (time varying impedance) sensor,

• via an inductive type sensor, and

• via a linear variable differential transformer (LVDT)

The application of force and measurement of displacement may be accomplished by a single device For example, a piezoelectric material may be used for the resonant mass (not shown) and a time-varying voltage / current may be applied to the piezoelectric mateπal to create a time-varying force The resulting voltage / current applied to the piezoelectric material may be

111 measured and the transfer function between the two used to estimate the natural frequency of volume sensor assembly 148

₂ O¹A 1 ω_n =

^{L V}l |EQ#126]

₂ yRA T

^{1 V}2 |EQ#126]

T

°>^« ,E(WI-TI yRA

Where c is the calibration constant C =

L

Infusion pump assembly 100 may then compare this calculated volume V₂ (1 e , representative of the actual volume of infusible fluid delivered to the user) to the target volume (1 e , representative of the quantity of fluid that was supposed to be delivered to the user) For example, assume that infusion pump assembly 100 was to deliver a 0 100 unit basal dose of infusible fluid to the user every thirty minutes Further, assume that upon effectuating such a delivery, volume sensor assembly 148 indicates a calculated volume V₂ (1 e , representative of the actual volume of infusible fluid delivered to the user) of 0 095 units of infusible fluid

When calculating volume V₂, infusion pump assembly 100 may first determine the volume of fluid within volume sensor chamber 620 prior to the administration of the dose of infusible fluid and may subsequently determine the volume of fluid within volume sensor chamber 620 after the administration of the dose of infusible fluid, wherein the difference of

112 those two measurements is indicative of V2 (1 e , the actual volume of infusible fluid delivered to the user) Accordingly, V₂ is a differential measurement

V2 may be the total air space over the diaphragm in the variable volume chamber The actual fluid delivery to the patient may be the difference in V2 from when the chamber was full to after the measurement valve was opened and the chamber was emptied V2 may not directly be the delivered volume For example, the air volume may be measured and a series of differential measurements may be taken For occlusion, an empty measurement may be taken, the chamber may be filed, a ftill measurement may be taken, and then a final measurement may be taken after the exit valve is open Accordingly, the difference between the first and second measurement may be the amount pumped and the difference between the second and third is the amount delivered to the patient

Accordingly, electrical control assembly 1 10 may determine that the infusible fluid delivered is 0 005 units under what was called for In response to this determination, electrical control assembly 110 may provide the appropriate signal to mechanical control assembly 104 so that any additional necessary dosage may be pumped Alternatively, electrical control assembly 1 10 may provide the appropriate signal to mechanical control assembly 104 so that the additional dosage may be dispensed with the next dosage Accordingly, during administration of the next 0 100 unit dose of the infusible fluid, the output command for the pump may be modified based on the difference between the target and amount delivered

Referring also to FIG 110, there is shown one particular implementation of a control system for controlling the quantity of infusible fluid currently being infused based, at least in part, on the quantity of infusible fluid previously administered Specifically and continuing with the above-stated example, assume for illustrative purposes that electrical control assembly 1 10 calls for the delivery of a 0 100 unit dose of the infusible fluid to the user Accordingly, electrical control assembly 110 may provide a target differential volume signal 1600 (which identifies a partial basal dose of 0 010 units of infusible fluid per cycle of shape memory actuator 1 12) to volume controller 1602 Accordingly and in this particular example, shape memory actuator 112 may need to be cycled ten times in order to achieve the desired basal dose of 0 100 units of infusible fluid (1 e , 10 cycles x 0010 units per cycle = 0 100 units) Volume controller 1602 in turn may provide "on-time" signal 1606 to SMA (1 e , shape memory actuator) controller 1608 Also provided to SMA controller 1608 is battery voltage signal 1610

113 Specifically, shape-memory actuator 112 may be controlled by varying the amount of thermal energy (e g , joules) applied to shape-memory actuator 112 Accordingly, if the voltage level of battery 606 is reduced, the quantity of joules applied to shape-memory actuator 112 may also be reduced for a defined period of time Conversely, if the voltage level of battery 606 is increased, the quantity of joules applied to shape memory actuator 112 may also be increased for a defined period of time Therefore, by monitonng the voltage level of battery 606 (via battery voltage signal 1610), the type of signal applied to shape-memory actuator 112 may be vaπed to ensure that the appropriate quantity of thermal energy is applied to shape-memory actuator 112 regardless of the battery voltage level

SMA controller 1608 may process "on-time" signal 1606 and battery voltage signal 1610 to determine the appropπate SMA drive signal 1612 to apply to shape-memory actuator 112 One example of SMA drive signal 1612 may be a seπes of binary pulses in which the amplitude of SMA drive signal 1612 essentially controls the stroke length of shape-memory actuator 112 (and therefore pump assembly 106) and the duty cycle of SMA drive signal 1612 essentially controls the stroke rate of shape-memory actuator 112 (and therefore pump assembly 106) Further, since SMA drive signal 1612 is indicative of 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 be indicative of the total quantity of infusible fluid infused during a plurality of cycles of shape memory actuator 112 For example, since (as discussed above) it may take ten cycles of shape memory actuator 112 (at 0010 units per cycle) 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 quantity infused of infusible fluid (as represented by volume signal 1616)

SMA dπve signal 1612 may actuate pump assembly 106 for e g one cycle, resulting in the filling of volume sensor chamber 620 included within volume sensor assembly 148 Infusion pump assembly 100 may then make a first measurement of the quantity of fluid included within volume sensor chamber 620 (as discussed above) Further and as discussed above, measurement valve assembly 610 may be subsequently energized, 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 make a measurement of the quantity of fluid included within volume sensor chamber 620 (as described above) and use those two measurements to determine V₂ (1 e , the actual

114 volume of infusible fluid delivered to the user during the current cycle of shape memory actuator 112) Once determined, V₂ (1 e , as represented by signal 1618) may be provided (1 e , fed back) to volume controller 1602 for comparison to the earlier-received target differential volume

Referring also to FIG 112, there is shown one possible embodiment of feed forward controller 1652 In this particular implementation, feed forward controller 1652 may define a constant value signal 1658 and may include amplifier 1660 (e g , a unity gain amplifier), the output of which may be summed with constant value signal 1658 at summing node 1662 The resulting summed signal (1 e , signal 1664) may be provided to as an input signal to e g , lookup table 1666, which may be processed to generate the output signal of feed forward controller 1652

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

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

When applying power to shape-memory actuator 112, voltage may be applied for a fixed amount of time and a) at a fixed duty cycle with an unregulated voltage, b) at a fixed duty cycle with a regulated voltage, c) at a vaπable duty cycle based upon a measured current value, d) at a variable duty cycle based upon a measured voltage value, and e) at a variable duty cycle based

116 upon the square of a measured voltage value Alternatively, voltage may be applied to shape- memory actuator 112 for a variable amount of time based upon a measured impedance

When applying a regulated voltage for a fixed amount of time at a fixed duty cycle, inner loop feedback may not be used and shape memory actuator 1 12 may be driven at a fixed duty cycle and with an on-time determined by the outer volume loop

When applying an unregulated voltage at a variable duty cycle based upon a measured current value, the actual current applied to shape-memory actuator 112 may be measured and the duty cycle may be adjusted during the actuation of shape-memory actuator 1 12 to maintain the correct mean current

When applying an unregulated voltage at a vaπable duty cycle based upon a measured voltage value, the actual voltage applied to shape-memory actuator 112 may be measured and the duty cycle may be adjusted during the actuation of shape-memory actuator 1 12 to maintain the correct mean voltage

When applying an unregulated voltage at a variable duty cycle based upon the square of a measured voltage value, the actual voltage applied to shape-memory actuator 1 12 may be measured and the duty cycle may be adjusted during the actuation of shape-memory actuator 112 to maintain the square of the voltage at a level required to provide the desired level of power to shape-memory actuator 112 (based upon the impedance of shape-memory actuator 112)

Referring also to FIG 114A-1 14B, there is shown other implementations of SMA controller 1608 Specifically, FIG 114A is an electrical schematic that includes a microprocessor and various control loops that may be configured to provide a PWM signal that may open and close the switch assembly The switch assembly may control the current that is allowed to flow through the shape memory actuator The battery may provide the current to the shape memory actuator Further, 114B discloses a volume controller and an inner shape memory actuator controller The shape memory actuator controller may provide a PWM signal to the pump, which may be modified based on the battery voltage This may occur for a fixed ontime, the result being a volume that may be measured by volume sensor assembly 148 and fed back into the volume controller

117 In our preferred embodiment, we vary the duty cycle based on the measured battery voltage to give you approximately consistent power We adjust the duty cycle to compensate for a lower battery voltage Battery voltage may change for two reasons 1 ) as batteries are discharged, the voltage slowly decreases, and 2) when you apply a load to a battery it has an internal impedence so its voltage dips This is something that happens in any type of system, and we compensate for that by adjusting the duty cycle, thus mitigating the lower or varying battery voltage Battery voltage may be measured by the microprocessor In other systems 1 ) voltage may be regulated (put a regulator to maintain the voltage at a steady voltage), 2) feedback based on something else (i e , speed or position of a motor, not necessarily measuπng the battery voltage)

Refemng also to FIG 115 and as discussed above, to enhance the safety of infusion pump assembly 100, electrical control assembly 110 may include two separate and distinct microprocessors, namely supervisor processor 1800 and command processor 1802 Specifically, command processor 1802 may perform the functions discussed above (e g , generating SMA dπve signal 1612) and may control relay / switch assemblies 1804, 1806 that control the functionality of (in this example) shape memory actuators 112, 632 (respectively) Command processor 1802 may receive feedback from signal conditioner 1808 concerning the condition (e g , voltage level) of the voltage signal applied to shape memory actuators 112, 632 Command processor 1800 may control relay / switch assembly 1810 independently of relay / switch

118 assemblies 1804, 1806 Accordingly, when an infusion event is desired, both of supervisor processor 1800 and command processor 1802 must agree that the infusion event is proper and must both actuate their respective relays / switches In the event that either of supervisor processor 1800 and command processor 1802 fails to actuate their respective relays / switches, the infusion event will not occur Accordingly through the use of supervisor processor 1800 and command processor 1802 and the cooperation and concurrence that must occur, the safety of infusion pump assembly 100 is enhanced

As discussed above and as illustrated in FIGS 115-116, to enhance the safety of infusion pump assembly 100, electrical control assembly 110 may include a plurality of microprocessors

119 (e g , supervisor processor 1800 and command processor 1802), each of which may be required to interact and concur in order to effectuate the delivery of a dose of the infusible fluid In the event that the microprocessors fail to interact / concur, the delivery of the dose of infusible fluid may fail and one or more alarms may be triggered, thus enhancing the safety and reliability of infusion pump assembly 100

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 deenergize 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 quantity of infusible fluid pumped by pump assembly 106 This may be accomplished by measuring the current quantity of fluid within volume sensor chamber 620 and comparing it with the quantity determined above (in step 1900) Once determined 1924, command processor 1802 may provide 1926 a "valve open power request" message to supervisor processor 1800 Upon

120 receiving 1928 the "valve open power request" message, supervisor processor 1800 may energize 1930 relay / switch 1810 (thus energizing shape memory actuator 632) and may send 1932 a "valve open power on" message to command processor 1802 Upon receiving 1934 the "valve open power on" message, command processor 1802 may actuate 1936 e g , measurement valve assembly 610 (by energizing relay / switch 1806), duπng which time supervisor processor 1800 may monitor 1938 the actuation of e g , measurement valve assembly 610

Upon receiving 1948 the "valve power off' message, command processor 1802 may provide 1950 a "valve close power request" message to supervisor processor 1800 Upon receiving 1952 the "valve close power request" message, supervisor processor 1800 may energize 1954 relay / switch 1810 (thus energizing shape memory actuator 652) and may send 1956 a "power on" message to command processor 1802 Upon receiving 1958 the "power on" message, command processor 1802 may actuate 1960 an energizing relay / switch (not shown) that is configured to energize shape memory actuator 652, during which time supervisor processor 1800 may monitor 1962 the actuation of e g , shape memory actuator 652

As discussed above (and referring temporarily to FIGS 26A, 26B, 27A, 27B & 28), shape memory actuator 652 may be anchored on a first end using electrical contact 654 The other end of shape memory actuator 652 may be connected to bracket assembly 656 When shape memory actuator 652 is activated, shape memory actuator 652 may pull bracket assembly 656 forward and release valve assembly 634 As such, 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 latch 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 de-activated state once bracket assembly 656 has released valve assembly 634 Accordingly, by actuating shape memory actuator 652, measurement valve assembly 610 may be deactivated

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

Referring also to FIG 118, there is shown another illustrative example of the interaction amongst processors 1800, 1802, this time during the scheduling of a dose of infusible fluid Command processor 1802 may monitor 2000, 2002 for the receipt of a basal scheduling message or a bolus request message (respectively) Upon receipt 2000, 2002 of either of these messages, command processor 1802 may set 2004 the 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 veπfied 2010, supervisor processor 1800 may provide 2012 a "delivery accepted" message to command processor 1802 Upon receipt 2014 of the "delivery accepted" message, command processor 1802 may update 2016 the controller (e g , the controller discussed above and illustrated in FIG 110) and execute 2018 delivery of the basal / bolus dose of infusible fluid Command processor 1808 may monitor and update 2022 the total quantity of infusible fluid delivered to the user (as discussed above and illustrated in FIGS 117A-117B) Once the appropπate quantity of infusible fluid is delivered to the user, command processor 1802 may provide 2024 a "delivery done" message to supervisor processor 1800 Upon receipt 2026 of the "delivery done" message, supervisor processor 1800 may update 2028 the total quantity of infusible fluid delivered to the user In the event that the total quantity of infusible fluid delivered 2018 to the user is less than the quantity defined above (in step 2004), the infusion process discussed above may be repeated (via loop 2030)

122 Referring also to FIG 119, there is shown an example of the manner in which supervisor processor 1800 and command processor 1802 may interact while effectuating a volume measurements via volume sensor assembly 148 (as described above)

Remote control assembly 300 may include two processors, 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 communication, e g , for

123 communicating with infusion pump assembly 100, 100', 400, 500 The second processor included within remote control assembly (which may include but are not limited to an ARM920T and an ARM922T manufactured by ARM Holdings PLC of the United Kingdom) may be a command processor and may perform data processing tasks associated with e g , configuring infusion pump assembly 100, 100', 400, 500

The SysClocks class may contain the functionality to place the processor (e g , supervisor processor 1800 and/or command processor 1802) into LPM to reduce energy consumption While m 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

124 Placing the processor into LPM may always be done by the provided SysClocks function This function may contain all required power down and power up sequences resulting in consistency whenever enteπng or exiting LPM Waking from LPM may be initiated by any interrupts based on the slow clock

The ManagedFunc base class may have five control members, two scheduling manipulation member functions, and one pure virtual execute function that may contain the managed functionality AU of the ManagedFunc control members may be hidden from the

125 derived class and may only be directly set by the derived class during creation, thus simplifying the use and enhancing the safety of infusion pump assembly 100, 100', 400, 500

The following is an illustrative code example concerning the creation of a managed 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 execute every ten seconds thereafter

126 tinclude "ManagedFunc.h"

{ public:

// Initialize the managed func to run 2 seconds after start up

// and repeat every second.

SendGoodFunc ( ) :

ManagedFunc (IPC_SEND_GOOD, SCHEDULED_SEC, 1, true, 10) {};

-SendGoodFunc ( ) { } ; protected: void execute (void) ;

}; void SendGoodFunc : : execute (void) {

// « code to send the heartbeat »

}

SendGoodFunc g_sendGoodFunc;

// to manipulate the heartbeat timing simply call:

// g_sendGoodFunc.setFuncStart (...) or g_sendGoodFunc . setRepeat ( ... )

The main role of the SleepManager class may be to have its 'manage' function called repeatedly from the processors main loop and/or from a endless while loop. Upon each call of manage, the SleepManager may execute all functions that are scheduled to run until the SleepManager has exhausted all scheduled functions; at which time the SleepManager may place the processor in LPM. Once the processor wakes from LPM, the manage function may be reentered until the processor is again ready to enter LPM (this process may be repeated until stopped, e.g., by a user or by the system).

127 If the processor has to be kept in full power mode for an extended period of time (e g , while an analog-to-digital conversion is being sampled), the SleepManager may provide functionality to disable entenng LPM While LPM is disabled, the manage function may continuously search for a scheduled task

Referring also to FIG 120A, there is shown one illustrative example of the various software layers of the radio communication system discussed above

128 The radio processors included within remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 may transfer messaging packets between an SPI port and a 2 4 GHz radio link (and vice versa) The radio may always be the SPI slave On infusion pump assembly 100, 100', 400, 500, radio processor (PRP) 1818 (See FIGS 115-116) may service two additional nodes over the SPI port that are upstream (namely command processor 1800 and supervisor processor 1802 In some embodiments, on remote control assembly 300, the radio processor (CRP) may service at least one additional node over the SPI port that may be either upstream or down stream, for example, in some embodiments, the above-described remote control processor (UI) and the Continuous Glucose Engine (CGE)

The radio seπal 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 that may only include the radio seπal number of remote control assembly 300, thus ensuring that only occur with the remote control assembly / infusion pump

129 assembly to which it is paired The CC2510 may support a one byte logical node address and it may be advantageous to use one byte of the radio seπal number as the logical node address to provide a level of filtering for incoming packets

The Quiet_Radio signal may be used by the UI processor of remote control assembly 300 to prevent noise interference on the board of remote control assembly 300 by 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 asserting Radio Quiet Mode for a pre-determined peπod of time The Quiet Radio feature may not be required based on noise interference levels measured on the PC board of remote control assembly 300 During this period of time, the radio of remote control assembly 300 may stay in Sleep Mode 2 for up to a maximum of 100 ms The radio of remote control assembly 300 may come out of Sleep Mode 2 when the Quiet_Radio signal is de-asserted or the maximum time peπod has expired The UI processor of remote control assembly 300 may assert Quiet_Radio at least one radio communication's interval before the event needs to be asserted The radio of remote control assembly 300 may inform the radio of infusion pump assembly 100, 100', 400, 500 that communications will be shutdown during this quiet period The periodic radio link protocol may have status bits / bytes that accommodate the Quiet_Radio feature unless Quiet_Radio is not required

The radio software may integrate with the messaging system and radio bootloader on the same processor, and may be veπfied using a throughput test The radio software may integrate with the messaging system, SPI Dπver using DMA, and radio bootloader, all on the same processor (e g , the TI CC2510)

The maximum time to reacquire communications may be < 6 1 seconds including connection request mode and acquisition mode The radio of remote control assembly 300 may use the fast heartbeat mode or slow heartbeat mode setting to its advantage in order to conserve power and minimize latency to the user The difference between the infusion pump assembly

130 100, 100', 400, 500 and remote control assembly 300 entenng acquisition mode may be that the infusion pump assembly 100, 100', 400, 500 needs to enter acquisition mode often enough to ensure communications may be restored within the maximum latency period However, the remote control assembly 300 may change how often to enter acquisition mode with the infusion pump assembly 100, 100', 400, 500 when in slow heartbeat mode and heartbeats are lost The radio of remote control assembly 300 may have knowledge of the user GUI interaction, but the infusion pump assembly 100, 100', 400, 500 may not

The radio of remote control assembly 300 may set the heartbeat peπod for both radios The period may be selectable m order to optimize power and link latency depending on activity The desired heartbeat period may be communicated in each heartbeat from the radio of remote control assembly 300 to the radio of infusion pump assembly 100, 100', 400, 500 This may not exclusively establish the heartbeat rate of infusion pump assembly 100, 100', 400, 500 due to other conditions that determine what mode to be in When in fast heartbeat mode, the radio of remote control assembly 300 may set the heartbeat peπod to 20 ms if data packets are available to send or receive, thus providing low link latency communications when data is actively being exchanged

When in fast heartbeat mode, the radio of remote control assembly 300 may set the heartbeat peπod to 60 ms four heartbeats after a data packet was last exchanged in either direction on the radio Keeping the radio heartbeat penod short after a data packet has been sent or received may assure that any data response packet may be also serviced using a low link latency When in slow heartbeat mode, the heartbeat rate may be 2 00 seconds or 6 00 second, depending upon online or offline status respectively

• Paiπng Mode

• Connection Mode

• Sync Mode - Fast Heartbeat

• Sync Mode - Slow Heartbeat

131 • RF Off Mode

• Pairing Mode

• Acquisition Mode

• RF Off Mode

• Online Fast: Successful connection

• Online Fast: Change from Acquisition Mode to Fast Heartbeat Mode

• Offline: Bandwidth falls below 10% in Sync Mode

• Online: Bandwidth rises above 10% in Search Sync mode

• Offline: Successful request change to RF Off Mode

There may be two parameters in the radio configuration message: namely the number of RF retries (e.g., the value may be from 0 to 10); and the radio offline parameters (e.g., the value may be from 1 to 100 in percent of bandwidth).

132 The radio application on both the 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

• Base Radio Specifications

• MSK

• 250 kbps over air baud rate

• Up to 84 channels

• Channel spacing 1000 kHz

• Filter bandwidth 812 kHz

• No Manchester encoding

• Data whitening

• 4 byte preamble

• 4 byte sync (word)

• CRC appended to packet

• LQI (Link Quality Indicator) appended to packet

• Automatic CRC filtering enabled

The radio may function within 1 83 meters distance under nominal operating conditions (except in pairing mode) It may be a goal that the radio function within 7 32 meters distance under nominal operating conditions The transmit power level may be 0 dBm (except in pairing mode) and the transmit power level in paiπng mode may be -22 dBm Since the desired radio node address of infusion pump assembly 100, 100', 400, 500 may be not known by the remote control assembly 300 in paiπng mode, both infusion pump assembly 100, 100', 400, 500 and remote control assembly 300 may use a lower transmit power to reduce the likelihood of inadvertently pairing with another infusion pump assembly

133 AES Encryption may be used for all packets but may not be required, as the Texas Instruments CC2510 radio transceiver includes this functionality IfAES encryption is used, fixed keys may be utilized, as fixed keys provide a quick way to enable encryption without passing keys However, key exchange may be provided for in future versions of infusion pump assembly 100, 100', 400, 500 The fixed keys may be contained in one separate header source file with no other variables but the fixed keys data, thus allowing for easier management of read access of the file

The radio software may support the following eight modes

• Pairing Mode

• RF Off Mode

• Connection Mode

• Acquisition Mode

• Fast Heartbeat Mode

• Slow Heartbeat Mode

• Search Sync Mode

• Sync'ed Acquisition Mode which are graphically depicted in FIGS 120B- 12OC

Paiπng may be the process of exchanging radio seπal numbers between remote control assembly 300 and infusion pump assembly 100, 100', 400, 500 Remote control assembly 300 may be "paired" with infusion pump assembly 100, 100', 400, 500 when infusion pump assembly 100, 100', 400, 500 knows its seπal number Infusion pump assembly 100, 100', 400, 500 may be "paired" with remote control assembly 300 when remote control assembly 300 knows its seπal number

• RF Paiπng Acknowledge (from Infusion pump assembly 100, 100', 400, 500 to Remote control assembly 300)

134 • RF Pairing Confirm Request (from Remote control assembly 300 to Infusion pump assembly 100, 100', 400, 500)

The radio of infusion pump assembly 100, 100', 400, 500 may enter paiπng mode upon receiving a pairing mode request message It may be the responsibility of supervisor processor 1800 on infusion pump assembly 100, 100', 400, 500 to request the radio to enter paiπng mode if there is no disposable 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 six seconds The radio of infusion pump assembly 100, 100', 400, 500 may set the appropriate transmit power level for pairing mode Infusion pump assembly 100, 100', 400, 500 may only be paired with one remote control assembly 300 at a time

The radio of infusion pump assembly 100, 100', 400, 500 may timeout of paiπng mode automatically after 2 0 ± 02 seconds if no RF paiπng request is received The radio of infusion pump assembly 100, 100', 400, 500 may issue a paiπng request received message after transmitting the RF paiπng acknowledge This message to supervisor processors will allow feedback to the user during the paiπng confirm process The radio of infusion pump assembly 100, 100', 400, 500 may automatically timeout of paiπng mode in 1 0 ± 0 1 minutes after sending an RF paiπng acknowledge unless an RF painng confirm request is received The radio of infusion pump assembly 100, 100', 400, 500 may issue a store paired radio seπal number message if an RF paiπng confirm request message is received after receiving a RF pairing request message This action may store the radio serial number of remote control assembly 300

135 in the non-volatile memory of infusion pump assembly 100, 100', 400, 500 and may overwrite the existing pairing data for the infusion pump assembly 100, 100', 400, 500

If the radio of infusion pump assembly 100, 100', 400, 500 exits pairing mode upon successfully receiving a paiπng confirm request message, then the radio of infusion pump assembly 100, 100', 400, 500 may revert to the newly paired remote control assembly 300 and may send a paiπng completion success message to command processor 1802 The radio of infusion pump assembly 100, 100', 400, 500 may exit pairing mode upon receiving an RF pairing abort message The radio of infusion pump assembly 100, 100', 400, 500 may exit pairing mode upon receiving a painng abort request message addressed to it This may allow command processor 1802 or supervisor processor 1800 to abort the paiπng process locally on the infusion pump assembly 100, 100', 400, 500

The radio of remote control assembly 300 may enter pairing mode upon receiving a pairing mode request message It may be the responsibility of the UI processor of remote control assembly 300 to request that the radio enter painng mode under the appropnate conditions The radio of remote control assembly 300 may set the appropriate transmit power level for paiπng mode The radio of remote control assembly 300 may transmit RF painng requests until an RF pairing acknowledge is received or paiπng is aborted

The radio of remote control assembly 300 may automatically abort pairing mode if the RF paiπng acknowledge message is not received within 300 ± 1 0 seconds after entering pairing mode Upon receiving the first valid RF pairing acknowledge message while in paiπng mode, the radio of remote control assembly 300 may send a painng success message to the UI processor of remote control assembly 300 that includes the seπal number of infusion pump assembly 100, 100', 400, 500 and may use that seπal number for the duration of paiπng mode This message may provide a means for the UI processor of remote control assembly 300 to have the user 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 (concerning a single

136 pairing request) from infusion pump assembly 100, 100', 400, 500, the first valid one may be used

The radio of remote control assembly 300 may obtain the latest paired infusion pump assembly serial number list upon entering connection mode The radio of remote control assembly 300 may enter connection mode upon receiving a connection mode request message It

137 may be the responsibility of the UI processor of remote control assembly 300 to request that the radio enter connection mode when it desires communications with a paired infusion pump assembly The radio of remote control assembly 300 may issue a connection assessment message to the UI processor of remote control assembly 300 containing the radio seπal number of the first infusion pump assembly, if any, that is "connection ready" The radio of remote control assembly 300 may generate the connection assessment message within thirty seconds of entering connection request mode The radio of remote control assembly 300 may exit connection request mode upon receipt of the connection assessment acknowledgement and transition to fast heartbeat mode The radio of remote control assembly 300 may exit connection request mode upon receipt of a connection request abort message from the UI processor of remote control assembly 300

On remote control assembly 300, acquisition mode may be used to find a particular paired infusion pump assembly The radio of remote control assembly 300 may send RP RUT (aRe yoU There) packets 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 opportunity for the radio of remote control assembly 300 to find the paired infusion pump assembly

The radio of remote control assembly 300 may only communicate with one paired infusion pump assembly 100, 100', 400, 500 (except in painng and connection modes) When communications are 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 communications

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

138 • When in Radio Off Mode and Acquisition Mode may be requested

• When Search Sync Mode times out due to lack of heartbeats

Upon entering acquisition mode, the radio of infusion pump assembly 100, 100', 400, 500 may obtain the serial number of the last stored paired remote control assembly 300 The radio of infusion pump assembly 100, 100', 400, 500 may only communicate with the remote control assembly to which it has been "paired" (except while in the "pairing request" mode) The radio of infusion pump assembly 100, 100', 400, 500 may transition from acquisition mode to fast heartbeat mode upon successfully acquiring synchronization with the remote control assembly 300 The acquisition mode of infusion pump assembly 100, 100', 400, 500 may be capable of acquinng synchronization within 6 1 seconds, which may implies that the infusion pump assembly 100, 100', 400, 500 may always be listening at least every ~6 seconds when in acquisition mode

Upon transitiomng to fast heartbeat mode from acquisition mode, the radio of remote control assembly 300 may send the master channel list message The master channel list may be built by the radio of remote control assembly 300 and sent to the radio of infusion pump assembly 100, 100', 400, 500 to allow a selection of frequency hopping channels based on historical performance When in fast heartbeat mode or slow heartbeat mode, peπodic 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 periodicity of these messages may be at the heartbeat rate The heartbeat messages may allow data packet transfers to take place and may also exchange status information The two radios may exchange the following status information Quiet Mode, data availability, buffer availability, heartbeat rate, and prior channel

139 performance It may be a goal to keep the packet size of the heartbeat messages small in order to conserve power The radio may provide for a maximum data packet size of eighty-two bytes when in Sync Mode The messaging system may be designed to support packet payload sizes up to sixty-four bytes This maximum size was selected as an optimal trade-off between minimum messages types and non-fragmented messages The eighty-two bytes may be the maximum packet size of the messaging system including packet overhead

The messaging system has an API that may allow the radio protocol to send an incoming radio packet to it The messaging system may also have an API that allows the radio protocol to get a packet for transmission over the radio network The messaging system may be responsible for packet routing between the radio protocol and the SPI port Data packets may be given 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 over the radio network The radio protocol may query the messaging system on each heartbeat to determine if data packets are available to send over the radio network It may be desirable for the software to check the availability of a message just before the heartbeat is sent to minimize round trip message latency

The radio transmitting a radio data packet may retransmit that radio data packet on the next heartbeat with the same sequence number if an RF ACK is not received and the retry count is within the maximum RF retries allowed It may be expected that, from time to time, interference will corrupt a transmission on a particular frequency An RF retry allows the same packet to be retransmitted at the next opportunity at a different frequency The sequence number provides a means of uniquely identifying the packet over a short time window The number of

140 radio packet retries may be configurable using the radio configuration command Allowing more retries may increase the probability of a packet being exchanged but introduces more latency for a round trip messages The default number of radio retries at power up may be ten (i e , the maximum transmission attempts before dropping the message)

The radio may be considered online while in the following modes

• Fast Heartbeat mode

The radio may initialize to radio off mode at the start of code execution from reset When code first executes on the radio processor, the initial state may be the radio off mode to allow other processors to perform self-tests before requesting the radio to be active This requirement does not intend to define the mode when waking from sleep mode The radio may cease RF communications when set to radio off mode On remote control assembly 300, this

141 mode may be intended for use on an airplane to suppress RF emissions Since infusion pump assembly 100, 100', 400, 500 only responds to transmissions from remote control assembly 300 (which will have ceased transmitting in airplane mode), radio off mode may only be used on infusion pump assembly 100, 100', 400, 500 when charging

Command processor 1802 may be informed of airplane mode and that, therefore, the RF was intentionally turned off on remote control assembly 300 so that it does not generate walkaway alerts However, this may be completely hidden from the radio of infusion pump assembly 100, 100', 400, 5OO

The radio of infusion pump assembly 100, 100', 400, 500 may transition to acquisition mode after twenty minutes of search sync mode with no heartbeats successfully exchanged Listening during pre-agreed time slots may be the most efficient use of power for infusion pump assembly 100, 100', 400, 500 to re-establish the RF lmk After a loss of communications, the crystal tolerance and temperature drift may make it necessary to expand the receive window of infusion pump assembly 100, 100', 400, 500 over time Staying in search sync mode for extended peπods (e g , 5-20 minutes) after communications loss may cause the instantaneous power consumed to exceed 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 expand its window, so staying 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

The radio of remote control assembly 300 and the radio of infusion pump assembly 100, 100', 400, 500 may transition to slow heartbeat mode if they successfully exchange three of the last five heartbeats Approximately every six seconds, a burst of five heartbeats may be attempted If three of these are successful, the bandwidth may be assumed to be sufficient to transition to slow heartbeat mode The radio of infusion pump assembly 100, 100', 400, 500

142 may be acquirable while in search sync mode with a latency of 6 1 seconds This may imply that the infusion pump assembly 100, 100', 400, 500 may always be listening at least every ~6 seconds when in search sync mode

Radio protocol performance statistics may be necessary to promote troubleshooting of the radio and to assess radio performance The following radio performance statistics may be

143

• Number of missed hops

• CCA good count

• CCA bad count

• Average RSSI (accumulated for good RX packets only)

• Dropped from Frequency Hop List count

• Acquisition Mode count (found pair on this channel)

The radio may change frequency for each heartbeat An adaptive pseudo random frequency hopping algorithm may be used for sync mode and heartbeat attempts in search sync mode It may be a goal to use sixty-four channels for frequency hopping An algorithm may be developed to adaptively generate a channel list on remote control assembly 300 for frequency hopping The radio of remote control assembly 300 may build, maintain, and distribute the

144 master channel list Prior channel statistics and historical performance information may be obtained from the radio of infusion pump assembly 100, 100', 400, 500 by the radio of remote control assembly 300 using the 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 may be considered The radios may adaptively select hopping channels to meet the round trip message latency, while operating in a desirable RF environment

Occlusions and/or leaks may occur anywhere along the fluid delivery path of infusion pump assembly 100 For example and referring to FIG 121, occlusions / leaks may occur in the fluid path between reservoir 1 18 and reservoir valve assembly 614, m 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 occlusion / leak detection algorithms that detect and locate such occlusions / leaks and enhance the safety / reliability of infusion pump assembly 100

Specifically, if the tip of disposable cannula is occluded, the fluid path down stream of volume sensor chamber 620 will fill with fluid and eventually become pressurized to a level equivalent to the mechanical pressure exerted by spring diaphragm 628 Accordingly, upon measurement valve assembly 610 opening, zero (or essentially zero) fluid will be dispensed and,

145 therefore, the value of the initial and final measurements (as made by volume sensor assembly 148 ) will essentially be equal

Occlusion Type - Partial: When a partial occlusion is occurring, the difference between the initial measurement pπor to the administration of the dose of infusible fluid and the final measurement after the administration of the dose of infusible fluid will indicate that less than a complete dose of infusible fluid was delivered For example, assume that at the end of a particular pumping cycle, volume sensor assembly 148 indicated that 0 10 microliters of infusible fluid were present in volume sensor chamber 620 Further, assume that measurement value assembly 610 is subsequently closed and pump assembly 106 is subsequently actuated, resulting in volume sensor chamber 620 being filed with the infusible fluid Further 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)

Alternatively, infusion pump assembly 100 may calculate a pump ontime to volume delivered ratio, track it through time, and track by using a fast moving and a slow moving exponential average of the pump ontime The exponential average may be tracked, in a fashion

146 similar to the leaky sum integrator The infusion pump assembly 100 may filter signal and look for a fast change The rate of fluid outflow and/or residual volume may be monitored If the residual volume does not change, then there may be a total occlusion If the residual volume changed, they may be a partial occlusion Alternatively still, the residual values may be summed If the number of valve actuations or the latch time is being varied, the fluid flow rate may be examined, even if you build up pressure in volume sensor assembly 148

Total/ Partial Empty Reservoir: When reservoir 118 is becoming empty, it will become more difficult to fill volume sensor chamber 620 to the desired level Typically, pump assembly 106 is capable of pumping 1 0 microliters per millisecond For example, assume that an "empty" condition for volume sensor chamber 620 is 0 10 microliters and a "full" condition for volume sensor chamber 620 is 1 00 microliters However, as reservoir 118 begins to empty, it may become harder for pump assembly 106 to fill volume sensor chamber 620 to the "full" condition and may consistently miss the goal Accordingly, dunng normal operations, it may take one second for pump assembly 106 to fill volume sensor chamber 620 to the "full" condition and, as reservoir 118 empties, it may take three seconds to fill volume sensor chamber 620 to the "full" condition Eventually, if reservoir 118 completely empties, volume sensor chamber 620 may never be able to achieve a "full condition" Accordingly, the inability of pump assembly 106 to fill volume sensor chamber 620 to a "full" condition may be indicative of reservoir 118 being empty Alternatively, the occurrence of such a condition may be indicative of other situations (e g , the failure of pump assembly 106 or an occlusion in the fluid path prior to volume sensor chamber 620) Infusion pump assembly 100 may determine the difference between the "full" condition and the amount actually pumped These differences may be summed and the made up for once the reservoir condition is addressed

Additionally, as reservoir 118 empties, reservoir 118 will eventually result in a "vacuum" condition and the ability of pump assembly 106 to deliver fluid to volume sensor chamber 620 may be compromised As discussed above, volume controller 1602 may include feed forward controller 1652 for setting an initial "guess" concerning "on-time" signal 1606, wherein this initial guess is based upon a pump calibration curve For example, in order for pump assembly

147 106 to deliver 0 010 units of infusible fluid, feed forward controller 1652 may define an initial "on-time" of e g , one millisecond However, as reservoir 118 begins to empty, due to compromised pumping conditions, it may take two milliseconds to deliver 0 010 units of infusible fluid Further, as reservoir 118 approaches a fully empty condition, it make take ten milliseconds to deliver 0 010 units of infusible fluid Accordingly, the occurrence of reservoir 118 approaching an empty condition may be detected by monitoring the level at which the actual operation of pump assembly 106 (e g , two milliseconds to deliver 0 010 units of infusible fluid) differs from the anticipated operation of pump assembly 106 (e g , one millisecond to deliver 0010 units of infusible fluid)

Leak Detection: In the event of a leak (e g , a leaky valve or a rupture / perforation) within the fluid path, the ability of the fluid path to retain fluid pressure may be compromised Accordingly, in order to check for leaks within the fluid path, a bleed down test may be performed in which pump assembly 106 is used to pressurize volume sensor chamber 620 Volume sensor assembly 148 may then perform a first volume measurement (as described above) to determine the volume of infusible fluid within volume sensor chamber 620 Infusion pump assembly 100 may then wait a defined period of time to allow for bleed down in the event of a leak For example, after a sixty second bleed down penod, volume sensor assembly 148 may perform a second volume measurement (as described above) to determine the volume of infusible fluid within volume sensor chamber 620 If there are no leaks, the two volume measurements should be essentially the same However, in the event of a leak, the second measurement may be less then the first measurement Additionally, depending on the seventy of the leak, pump assembly 106 may be incapable of filling volume sensor chamber 620 Typically, a leak check may be performed as part of a delivery of infusible fluid

In the event that the difference between the first volume measurement and the second volume measurement exceeds an acceptable threshold, a leak flag may be set and infusion pump assembly 100 may e g , trigger an alarm, thus indicating that the user needs to seek alternative means for receiving their therapy

148 As discussed above, infusion pump assembly 100 may include supervisor processor 1800, command processor 1802, and radio processor 1818 Unfortunately, once assembled, access to electrical control assembly 110 within infusion pump assembly 100 very limited Accordingly, the only means to access electrical control assembly 110 (e g , for upgrading flash memories) may be through the communication channel established between infusion pump assembly 100, 100', 400, 500 and remote control assembly 300, or via electrical contacts 834 used by battery charger 1200

Referring also to FIG 122, there is shown one illustrative example of the manner in which the various systems within infusion pump assembly 100, 100', 400, 500 may be interconnected For example, battery charger 1200 may be coupled to computing device 2100 (e g , a personal computer) via bus translator 2102, which converts e g , RS232 formatted data to e g , I2C formatted data Bus translator 2102 may execute a pass-through program that effectuates the above-described translation Battery charger 1200 may be coupled to radio processor 181 via electrical contacts 834 (described above) Radio processor 1818 may then be coupled to supervisor processor 1800 and command processor 1802 via e g , an RS232 bus Radio processor 1818 may execute an update program that allows radio processor 1818 to control / orchestrate the updating of the flash memoπes accessible by supervisor processor 1800 and command processor 1802 Accordingly, through the use of the above-described coupling, software updates obtained by computing device 2100 may be uploaded to flash memory (not shown) accessible by supervisor processor 1800 and command processor 1802 The above- described software updates may be command line program that may be automatically invoked by a script process

149 As discussed above, infusion pump assembly 100, 100' 400, 500 may be configured to deliver an infusible fluid to a user Further and as discussed above, infusion pump assembly 100, 100' 400, 500 may deliver the infusible fluid via sequential, multi-part, infusion events (that may include a plurality of discrete infusion events) and/or one-time infusion events However, in some embodiments, infusion pump assembly 100, 100' 400, 500 may deliver stacking bolus infusion events For example, a user may request the delivery of a bolus, e g , 6 units While the 6 units are in the process of being delivered to the user, the user may request a second bolus, e g , 3 units In some embodiments of infusion pump assembly 100, 100' 400, 500 may deliver the second bolus at the completion of the first bolus

Examples of other such sequential, multi-part, infusion events may include but are not limited to a basal infusion event and an extended-bolus infusion event As is known in the art, a basal infusion event refers to the repeated injection of small (e g 005 unit) quantities of infusible fluid at a predefined interval (e g every three minutes) that may be repeated until stopped, e g , by a user or by the system Further, the basal infusion rates may be preprogrammed and may include specified rates for pre-programmed time-frames, e g , a rate of 050 units per hour from 6 00 am - 3 00 pm, a rate of 040 units per hour from 3 00 pm - 10 00 pm, and a rate of 035 units per hour from 10 00 pm - 6 00 am However, the basal rate may be 0025 units per hour, and may not change according to pre-programmed time-frames The basal rates may be repeated regularly / daily until otherwise changed

Referring also to FIG 123, assume for illustrative purposes only that the user configures infusion pump assembly 100, 100' 400, 500 to administer a basal dose (e g 005 units) of infusible fluid every three minutes The user may utilize remote control assembly 300 to define a basal infusion event for the infusible fluid (e g , 1 00 units per hour)

150 Infusion pump assembly 100, 100' 400, 500 may then determine an infusion schedule based upon the basal infusion event defined Once determined, infusion pump assembly 100, 100' 400, 500 may administer the sequential, multi-part, infusion event (e g , 005 units of infusible fluid every three minutes) Accordingly, while administering the sequential, multi-part, infusion event, infusion pump assembly 100, 100' 400, 500 may infuse a first 0 05 unit dose 2200 of the infusible fluid at t=0 00 (i e , a first discrete infusion event), may infuse a second 005 unit dose 2202 of the infusible fluid at t=3 00 (i e , a second discrete infusion event), may infuse a third 0 05 unit dose 2204 of the infusible fluid at t=6 00 (i e , a third discrete infusion event), may infuse a fourth 005 unit dose 2206 of the infusible fluid at t=9 00 (i e , a fourth discrete infusion event), and may infuse a fifth 005 unit dose 2208 of the infusible fluid at t=12 00 (i e , a fifth discrete infusion event) As discussed above, this pattern of infusing 005 unit doses of the infusible fluid every three minutes may be repeated until stopped, e g , by a user or by the system, in this example, as this is an illustrative example of a basal infusion event

Accordingly, the user may utilize remote control assembly 300 to define an extended bolus infusion event for the infusible fluid (e g , 020 units over the next six minutes), which may be confirmed in a manner discussed above While, in this example, the extended bolus infusion event is described as 020 units over the next six minutes, this is for illustrative purposes only and is not intended to be a limitation of this disclosure, as either or both of the unit quantity and total time interval may be adjusted upward or downward Once defined and/or confirmed, infusion pump assembly 100, 100' 400, 500 may determine an infusion schedule based upon the extended bolus infusion event defined, and may administer the infusible fluid For example,

151 infusion pump assembly 100, 100' 400, 500 may deliver 0 10 units of infusible fluid every three minutes for the next two interval cycles (or six minutes), resulting in the delivery of the extended bolus dose of infusible fluid defined by the user (i e , 020 units over the next six minutes)

Assume for illustrative purposes only that after the user programs infusion pump assembly 100, 100' 400, 500 via remote control assembly 300 to administer the first sequential, multi-part, infusion event (i e , 0 05 units infused every three minute interval repeated continuously) and administer the second sequential, multi-part, infusion event (i e , 0 10 units infused every three minute interval for two intervals), the user decides to eat a very large meal Predicting that their blood glucose level might increase considerably, the user may program infusion pump assembly 100, 100' 400, 500 (via remote control assembly 300) to administer a one-time infusion event An example of such a one-time infusion event may include but is not limited to a normal bolus infusion event As is known in the art, a normal bolus infusion event refers to a one-time infusion of the infusible fluid

Continuing with the above-stated example, once the user completes the programming of infusion pump assembly 100, 100' 400, 500 to deliver one-time infusion event 2214 (i e , the thirty-six unit bolus dose of the infusible fluid), upon infusion pump assembly 100, 100' 400, 500 determining that the one-time infusion event is available for administration, infusion pump

152 assembly 100, 100' 400, 500 may delay the administration of each sequential, multi-part infusion event and administer the available one-time infusion event

For illustrative purposes only, the first sequential, multi-part, infusion event may be represented within FIG 123 as 005 unit dose 2200 @ t=0 00, 005 unit dose 2202 @ t=3 00, 005 unit dose 2204 @ t=6 00, 005 unit dose 2206 @ t=9 00, and 0 05 unit dose 2208 @ t=12 00 As the first sequential, multi-part, infusion event as described above is a basal infusion event, infusion pump assembly 100, 100' 400, 500 may continue to infuse 0 05 unit doses of the infusible fluid at three minute intervals indefinitely (i e , until the procedure is cancelled by the user)

Accordingly and for illustrative purposes only, assume that upon completion of the programming of infusion pump assembly 100, 100' 400, 500 to deliver the thirty-six unit normal bolus does of the infusible fluid (i e , the one-time infusion event), infusion pump assembly 100, 100' 400, 500 begins administering one-time infusion event 2214 Being that one-time infusion event 2214 is comparatively large, it may take longer than three minutes (i e , the time interval

153 between individual infused doses of the sequential, multi-part, infusion events) and one or more of the individual infused doses of the sequential, multi-part, infusion events may need to be delayed

Once administration of one-time infusion event 2214 is completed by infusion pump assembly 100, 100' 400, 500, any discrete infusion events included within the sequential, multipart, infusion event that were delayed may be administered by infusion pump assembly 100, 100' 400, 500 Accordingly, once one-time infusion event 2214 (i e , the thirty-six unit normal bolus dose of the infusible fluid) is completely administered, infusion pump assembly 100, 100' 400, 500 may administer 005 unit dose 2202, 005 unit dose 2204, 005 unit dose 2206, 0 10 unit dose 2210, and 0 10 unit dose 2212

While infusion pump assembly 100, 100' 400, 500 is shown to administer 0 05 unit dose 2202, then 0 10 unit dose 2210, then 005 unit dose 2204, then 0 10 unit dose 2212, and then 005 unit dose 2206, this is for illustrative purposes only and is not intended to be a limitation of this disclosure, as other configurations are possible and are considered to be within the scope of this disclosure For example, upon infusion pump assembly 100, 100' 400, 500 completing the administration of one-time infusion event 2214 (i e , the thirty-six unit normal bolus dose of the infusible fluid), infusion pump assembly 100, 100' 400, 500 may administer all of the delayed discrete infusion events associated with the first sequential, multi-part infusion event (i e , namely 005 unit dose 2202, 005 unit dose 2204, and 005 unit dose 2206) Infusion pump assembly 100, 100' 400, 500 may then administer all of the delayed discrete infusion events associated with the second sequential, multi-part infusion event (i e , 0 10 unit dose 2210, and 0 10 unit dose 2212)

154 While one-time infusion event 2214 (i e , the thirty-six unit normal bolus dose of the infusible fluid) is shown as being infused beginning at t=3 00, this is for illustrative purposes only and is not intended to be a limitation of this disclosure Specifically, infusion pump assembly 100, 100' 400, 500 may not need to begin infusing one-time infusion event 2214 at one of the three-minute intervals (e g , t=0 00, t=3 00, t=6 00, t=9 00, or t=12 00) and may begin administering one-time infusion event 2214 at any time

Referring also to FIG 124 and for illustrative purposes, 005 unit dose 2202 is shown to include ten discrete infusion sub-events (e g , infusion sub-events 2216 _{1 10}), wherein a 0 005 unit dose of the infusible fluid is infused during each of the ten discrete infusion sub-events Additionally, 0 10 unit dose 2210 is shown to include ten discrete infusion sub-events (e g , infusion sub-events 2218 i ιo), wherein a 001 unit dose of the infusible fluid is delivered duπng each of the ten discrete infusion sub-events Further, one-time infusion event 2214 may include e g , three-hundred-sixty one-time infusion sub-events (not shown), wherein a 0 1 unit dose of the infusible fluid is delivered duπng each of the three-hundred-sixty one-time infusion sub- events The number of sub-events defined above and the quantity of the infusible fluid delivered during each sub-event is solely for illustrative purposes only and is not intended to be a limitation of this disclosure, as the number of sub-events and/or the quantity of the infusible fluid delivered duπng each sub-event may be increased or decreased depending upon e g , the design cπteπa of infusion pump assembly 100, 100' 400, 500

Before, after, or in between the above-descπbed infusion sub-events, infusion pump assembly 100, 100' 400, 500 may confirm the proper operation of infusion pump assembly 100, 100' 400, 500 through the use of any of the above-descπbed safety features (e g , occlusion detection methodologies and/or failure detection methodologies)

155 In the exemplary embodiments, the infusion pump assembly may be wirelessly controlled by a remote control device In the exemplary embodiments, a split πng resonator antenna may be used for wireless communication between the infusion pump assembly and the remote control device (or other remote device) The term "wirelessly controlled" refers to any device that may receive input, instructions, data, or other, wirelessly Further, a wirelessly controlled insulin pump refers to any insulin pump that may wirelessly transmit and/or receive data from another device Thus, for example, an insulin pump may both receive instructions via direct input by a user and may receive instructions wirelessly from a remote controller

Referring to FIG 127, an exemplary embodiment of a split πng resonator antenna adapted for use in a wirelessly controlled medical device, and is used in the exemplary embodiment of the infusion pump assembly, includes at least one split πng resonator antenna (hereinafter "SRR antenna") 2508, a wearable electπc circuit, such as a wirelessly controlled medical infusion apparatus (hereinafter "infusion apparatus") 2514, capable of poweπng the antenna, and a control unit 2522

In vaπous embodiments, a SRR antenna 2508 may reside on the surface of a nonconducting substrate base 2500, allowing a metallic layer (or layers) to resonate at a predetermined frequency The substrate base 2500 may be composed of standard pπnted circuit board mateπal such as Flame Retardant 2 (FR-2), FR-3, FR-4, FR-5, FR-6, G-10, CEM-I, CEM- 2, CEM-3, CEM-4, CEM-5, Polyimide, Teflon, ceramics, or flexible Mylar The metallic resonating bodies compnsing a SRR antenna 2508 may be made of two rectangular metallic layers 2502, 2504, made of, for example, platinum, indium, copper, nickel, stainless steel, silver or other conducting materials In other vaπous embodiments, a SRR antenna 2508 may contain only one metallic resonating body

In the exemplary embodiment, a gold-plated copper outer layer 2502, surrounds, without physically contacting, a gold-plated copper inner πng 2504 That is, the inner πng 2504 resides in the cavity 2510 (or aperture) formed by the outer layer 2502 The inner πng 2504 may contain a gap, or split 2506, along its surface completely seveπng the mateπal to form an incomplete πng shape Both metallic resonating bodies 2502, 2504 may reside on the same planar surface of the substrate base 2500 In such a configuration, the outer layer 2502 may by driven via a transmission line 2512 coupled to the outer layer 2502, for example Additionally, in vaπous other embodiments, a transmission line 2512 may be coupled to the inner πng 2504

156 Antenna design software, such as AWR Microwave Office, capable of simulating electromagnetic geometries, such as, antenna performance, may significantly decrease the time required to produce satisfactory dimensions compared to physically fabπcating and testing antennas Accordingly, with aid of such software, the SRR antenna 2508 may be designed such that the geometric dimensions of the resonant bodies 2502, 2504 facilitate an operational frequency of the 24GHz ISM Band FIG 132 depicts the exemplary dimensions of the inner πng 2504 and outer layer 2502, and the positioning of the cavity 2510 in which the inner πng 2504 resides The distance in between the outer layer 2502 and the inner πng 2504 is a constant 0005 inches along the perimeter of the cavity 2510 However, in other embodiments, the distance between the outer layer and the inner ring may vary and in some embodiments, the operational frequency may vary

In vaπous embodiments, a SRR antenna 2508 may have dimensions such that it could be categorized as electrically small, that is, the greatest dimension of the antenna being far less than one wavelength at operational frequency

In vaπous other embodiments, a SRR antenna 2508 may be composed of one or more alternatively-shaped metallic outer layers, such as circular, pentagonal, octagonal, or hexagonal, surrounding one or more metallic inner layers of similar shape Further, m various other embodiments, one or more metallic layers of a SRR antenna 2508 may contain gaps in the matenal, forming incomplete shapes

These results are favorable especially as compared with a non-split πng resonator antenna type, such as the Inverted-F Return loss of an Inverted-F antenna may exhibit a difference when the antenna contacts human skin, resulting in a low percentage of power transmitted outward from the antenna By way of example, as shown in FIG 133, and again focusing on the band of interest denoted by markers 1 and 2 on the graph, return loss of an Inverted-F antenna

157 prior to contact with human skin is near -25 dB at a frequency centered around 2 44 GHz Return loss during contact with human skin is nearly -2 dB at the same frequency, yielding approximately 37% power transmission

Integration with a Wireless Medical Device

An infusion apparatus 2514 may be worn directly on the human body By way of example, such a device may be attached on or above the hip joint in direct contact with human skin, placing the SRR antenna 2508 at risk of unintended dielectric loading causing a frequency shift in electrical operation However, in such an application, electrical characteπstics of the SRR antenna 2508 which allow it to be less sensitive to nearby parasitic objects are beneficial in reducing or eliminating degradation to the performance A controlling component, such as a control unit 2522 (generally shown in FIG 131), may be paired with an infusion apparatus 2514, and may be designed to transmit and receive wireless signals to and from the infusion apparatus 2514 at a predetermined frequency, which, in the exemplary embodiment, is the 24GHz Industrial Scientific and Medical Band ("ISM band") In the exemplary embodiment, the control unit 2522 serves as the main user interface through which a patient or third party may manage insulin delivery In other embodiments, infusion apparatus 2514 may utilize a SRR antenna 2508 to communicate with one or more control units 2522

In various embodiments, a number of different wireless communication protocols may be used in conjunction with the SRR antenna 2508, as the protocol and data types to be transferred are independent of the electrical characteπstics of the antenna However, in the exemplary embodiment, a bi-directional master/slave means of communication organizes the data transfer through the SRR antenna 2508 The control unit 2522 may act as the master by periodically polling the infusion apparatus 2514, or slave, for information In the exemplary embodiment, only when the slave is polled, the slave may send signals to the control unit 2522 only when the slave is polled However, in other embodiments, the slave may send signals before being polled Signals sent by way of this system may include, but are not limited to, control, alarm, status,

158 patient treatment profile, treatment logs, channel selection and negotiation, handshaking, encryption, and check-sum In some embodiments, transmission through the SRR antenna 2508 may also be halted during certain infusion operations as an added precaution against electrical disruption of administration of insulin to the patient

The electπcal circuitry coupled to the SRR antenna 2508 may apply an RF signal to the end of the transmission line 2512 nearest the circuitry, creating an electromagnetic field throughout, and propagating from, the SRR antenna 2508 The electπcal circuitry coupled to the SRR antenna 2508 facilitates resonance at a predetermined frequency, which, in the exemplary embodiment, is the 2 4GHz ISM band Preferably, transmission line 2512 and SRR antenna 2508 both have impedances of 50 Ohms to simplify circuit simulation and characterization However, m other vaπous embodiments, the transmission line and split πng resonator antenna may have other impendence values, or a different resonating frequency

Referring to FIG 129, a signal processing component(s) 2518, such as, a filter, amplifier, or switch, may be integrated into the transmission line 2512, or at some point between the signal source connection pins 2516 and the SRR antenna 2508 In the exemplary embodiment, the signal processing component 2518 is a band-pass filter to facilitate desired signal processing, such as, allowing only the exemplary frequency to be transmitted to the antenna, and rejecting frequencies outside that range In the exemplary embodiment, a Combhne band-pass filter 2518 may be included in the transmission line 2512 between the antenna and the signal source However in other embodiments, any other signal processing device, for example, but not limited to, filters, amplifiers, or any other signal processing devices known in the art

In vaπous embodiments, a SRR antenna 2508 may be composed of metallic bodies capable of resonating on a flexible or rigid substrate As shown in FIG 128 and FIG 129, the exemplary embodiment incorporates a curved SRR antenna on a flexible Polyimide substrate

159 2520 Polyimide may be the exemplary material because it tends to be more flexible than alternative substrates This configuration may allow for simplified integration into circular- shaped devices (such as a wirelessly controlled medical infusion apparatus 2514), devices with irregular-shaped external housing, or devices in which saving space is paramount

In various other embodiments, a SRR antenna 2508 may be integrated into a human or animal limb replacement As prosthetic limbs are becoming more sophisticated the electrical systems developed to control and simulate muscle movements require much more wiπng and data transfer among subsystems Wireless data transfer within a prosthetic limb may reduce weight through reduced physical wiπng, conserve space, and allow greater freedom of movement However, common antennas in such a system may be susceptible to dielectric loading Similar to the previously mentioned benefits of integrating a SRR antenna 2508 into a wirelessly controlled medical infusion apparatus, a prosthetic limb, such as a robotic arm, may also come into contact with human skin or other dielectric materials and benefit from the reduction of electncal disturbances associated with such an antenna In other vaπous embodiments, the SRR antenna 2508 may be integrated into any device compπsed of the electrical components capable of powenng and transmitting/receiving data to an antenna and susceptible to electrical disturbances associated with proximity to dielectric mateπals

In vaπous embodiments, a SRR antenna 2508 may be integrated into a configuration of medical components in which one or more implantable medical devices, operating within the human body, communicate wirelessly to a handheld, body-mounted, or remote control unit In certain embodiments, both body-mounted and in-body wireless devices may utilize a SRR antenna 2508 for wireless communication Additionally, one or more of the components utilizing a SRR antenna 2508 may be completely surrounded by human skin, tissue or other dielectric mateπal By way of example, such a configuration may be used in conjunction with a heart momtoπng/control system where stability and consistency of wireless data transmission are of fundamental concern

160 In various other embodiments, a SRR antenna 2508 may be integrated into the embodiments of the infusion pump assembly In some embodiments, the SRR antenna 2508 may be integrated into a configuration of medical components in which one or more electrical sensors positioned on, or attached to, the human body wirelessly communicate to a remote transceiving unit By way of example, a plurality of electrodes positioned on the body may be coupled to a wireless unit employing a SRR antenna 2508 for wireless transmission to a remotely located electrocardiogram machine By way of further example, a wireless temperature sensor in contact with human skin may employ SRR antenna 2508 for wireless communication to a controller unit for temperature regulation of the room in which the sensor resides System for Verification of Volume and Pumping

Infusion pump therapy includes volume and time specifications The amount of fluid dispensed together with the dispense timing are two cπtical factors of infusion pump therapy As discussed in detail below, the infusion pump apparatus and systems shown and descπbed herein provide for a method of dispensing fluid together with a device, system and method for measuπng the amount of fluid dispensed However, in a circumstance where the calibration and precision of the measurement device calibration is critical, there are advantages to determining any compromise in the precision of the measurement device as soon as possible Thus, there are advantages to off-board verification of volume and pumping

In one embodiment, a weight scale is used to determine the volume of fluid filled into the disposable and may also be used for verification by comparing the before-use volume with the after-use volume of the disposable In some embodiments, this is accomplished by weighing the disposable before and after reservoir filling is complete In some embodiments, the weight scale may be reset to zero) (i e , tared) to the disposable pπor to filling In other embodiments, a weight may be taken before the fill and afterwards In some embodiments, a processor may calculate the weight of the fluid filled and correlate the weight to a volume of fluid In some embodiments, the display on the scale may automatically display the volume of fluid that has

161 been filled in the reservoir The method of filling may be any discussed above, or an automatic fill, as discussed below In addition, in some embodiment, a pre- filled reservoir may be used and thus, filling is not necessary, rather, the weight would be taken pπor to loading the reservoir and after reservoir loading

Referring now to FIG 205, one embodiment of the system includes a combination charger, disposable fill and integrity verification station 2900 The charger station 2900 includes a charging section 2902 for a reusable assembly, a charging section 2904 for a remote control device, and a weight scale 2906 The weight scale 2906 in some embodiments may be sized to accommodate a disposable assembly 2908 In the exemplary embodiment, the station also includes a fill adapter septum 2910 that accepts a filling cap 2912 (including a filling needle for piercing the septum 2910) In some embodiments, the filling needle is attached to a fluid line 2914 which may be a flexible tubing of a predetermined length suitable for reaching around the station 2900 to, in some embodiments, a fluid vial or fluid container holder 2916 The container holder 2916 may be sized to accommodate a fluid vial 2918 In addition to the features shown in FIG 205, in some embodiments, the station 2900 may include a pump for pumping the fluid from the container 2918 into the disposable assembly 2908 In some embodiments, the pump may be a peristaltic pump However, in other embodiments, the pump may be a diaphragm pump or any of pump known in the art The pump may be used to automatically fill the reservoir in the disposable 2908 In some embodiment, a user attaches the container cap 2920 (including a needle) to the fluid container 2918 as well as the filling cap 2912 to the fill adapter septum 2910 The pump evacuates air from the disposable and uses it to pressurize the vial The pump then pulls fluid from the container 2918 and fills the disposable 2908 reservoir Also,

162 whilst filling the reservoir, the system may provide enough positive pressure to additionally pπme the fluid path and the cannula of the disposable

163

Claims

What is claimed is:

1. A fill adapter system for an infusion pump assembly comprising: a reusable fill adapter base, the base comprising: a volume coiit.ro! mechanism to adjust an available fill volume of a ervoir of the infusion pump assembly; and a pump mechanism configured to pump air into a fktid via!; and a vial adapter assembly comprising: a first needle configured to penetrate a septum of the fluid vial for fiuidly upling the pump mechanism Io the fluid vial; and a second needle having a first, end configured to penetrate the septum of e fluid vial and a second end configured to penetrate a septum of the reservoir of the infusion mp assembly to allow transfer of fluid from the fluid vial to the reservoir of the infusion pump sembly in response to air being pumped into the fluid vial; and a needle carriage adapted to carry the first needle and the second needle, herein the needle carriage siidahiy attached to the interior of the vial adapter assembly, wherein e needle carriage adapted to slide from a vial end of the vial adapter to a receptacle end of the a! adapter.

The fill adapter of claim I wherein the vial adapter assembly further comprising a drophobic filter within a fluid path of the first needle.

The fill adapter of claim 1 wherein the volume control mechanism further comprising a n dial and a push plate, wherein the turn dial actuates the push plate and wherein the push ate adjusts the available fill volume of a reservoir of the infusion pump assembly.

The tilling system of claim 1 further comprising a weight scale, the weight scale termining the weight of the infusion pump assembly before filling a volume a fluid and the ight scale determining the weight of the infusion pump assembly after the reservoir is filled to olume.

164

5. A filling system for an infusion pump assembly comprising: a volume control mechanism configured to adjust an available fill volume of a ervoir of the infusion pump assembly; a pump mechanism configured to pomp air into a fluid vial via a first needle, the st needle configured to penetrate a septum of the fluid vial for fluidly coupling the pump echanism to the fluid vial; and a second needle having a first end configured to penetrate {be septum of the fioid al and a second end configured to penetrate a septum of the reservoir of the infusion pump sembly to allow transfer of fluid from the fluid vial to the reservoir of the infusion pump sembly in response to air being pumped into the fluid vial.

The filling system of claim 5 wherein the volume control mechanism further comprising urn dial and a push plate, wherein the turn dial actuates the push plate and wherein the push ate adjusts the available fill volume of a reservoir of the infusion pump assembly

The filling system of claim 5 further comprising a weight scale, the weight scale termining the weight of the infusion pump assembly before filling a volume a fluid and the ight scale determining the weight of the infusion pump assembly after the reservoir is filled to olume.

A vial adapter comprising: a housing having a vial end and a receptacle end and interior wall features; a needle carriage slidably attached to the interior of the housing; and a disc slidabϊy attached to the interior of the housing, the disc having a first sition on die receptacle end of the housing and a second position on the vial end of the housing d configured to matøbly attach to the needle carriage, wherein the needle carriage maiably attaches to the disc and the needle carriage and disc de to the vial end of the housing and wherein the disc is locked into a position on the vial end interior wall features of the housing.

165

9. The via! adapter of claim S further comprising at least one locking feature, the locking feature adapted to mate with at least one key feature on a fill adapter base.

166