Infusion pump assembly

Abstract

To provide a favorable infusion pump assembly.SOLUTION: A fluid connector assembly (6010) for attaching a tubing set to an infusion pump includes a body portion (6018), and a plug portion (6008) located on the body portion. The plug portion comprising a fluid path, a tubing, a first end of the tubing fluidly connected to the plug fluid path, a catch feature (6014) located on a first end of the body portion and configured to interact with a reservoir, and a latching feature (6016) located on a second end of the body portion, the latching feature configured to interact with and lock onto the reservoir.SELECTED DRAWING: Figure 236B

Description

Technical Field

[0001] (Field of the Invention) This application generally relates to fluid delivery systems, and more specifically to infusion pump assemblies.

Background Art

[0002] (Background) Many potentially valuable drugs or compounds, including biological agents, are not orally effective due to poor absorption rates, liver metabolism, or other pharmacokinetic factors. In addition, some therapeutic compounds can be absorbed orally but may require frequent administration, making it difficult for patients to maintain a desired schedule. In such cases, parenteral delivery is often or can be employed.

[0003] Effective parenteral routes for drug delivery and other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, involve piercing the skin with a needle or stylet. Insulin is an example of a therapeutic fluid self-injected by millions of diabetic patients. Users of parenteral delivery drugs would benefit from a wearable device that would automatically deliver the required drug / compound over a period of time.

[0004] To achieve this goal, efforts have been made to design portable and wearable devices for the controlled release of therapeutic agents. Such devices are known to have a reservoir, such as a cartridge, syringe, or bag, and to be electronically controlled. These devices have a number of drawbacks, including a malfunction rate. Reducing the size, weight, and cost of these devices is also an ongoing challenge. In addition, these devices often pose the problem of frequent repositioning for application to the skin.

Summary of the Invention

Means for Solving the Problems

[0005] (Summary of the Invention) According to one implementation, a fluid connector assembly is disclosed. The fluid connector assembly includes a body portion and a plug portion located on the body portion. The plug portion includes a fluid passage, a tube, a first end of the tube fluidly connected to the plug fluid passage, a capture feature located on a first end of the body portion and configured to interact with a reservoir, and a latching feature located on a second end of the body portion and configured to interact with and latch onto the reservoir.

[0006] Some embodiments of this implementation may include one or more of the following features. The body portion further includes a recess configured to interact with the reservoir. The capture feature includes an inclined surface. The second end of the tube is connected to a cannula assembly. The body portion further includes a tapered tube opening, and the first end of the tube is connected to the tapered tube opening. The lower surface of the body portion includes a core. The core includes an identification tag. The body portion includes an identification tag. The identification tag is an RFID tag. The identification tag is a short-range communication-readable RFID.

[0007] According to one implementation, a fluid reservoir system is disclosed. The fluid reservoir system includes a reservoir, a tab portion including a female latching feature, a disposable housing assembly including an outlet fluidly connected to the reservoir, a body portion, a plug portion located on the body portion and including a fluid passage, a male latching feature located on a first end of the body portion and configured to interact with the female latching feature on the disposable housing assembly, and a tube having a first end fluidly connected to the plug fluid passage. The plug of the connector is attached to the outlet of the disposable housing assembly to provide a fluid connection between the reservoir and the tube.

[0008] Some embodiments of this implementation may include one or more of the following features. The fluid connector further includes a capture feature located on a second end of the body portion and configured to interact with a disposable housing assembly. The capture feature includes an inclined surface. The second end of the tube is connected to a cannula assembly. The connector further includes a body, the body portion includes a recess, and the recess is configured to interact with a reusable portion of an infusion pump. The body portion further includes a tapered tube opening, and the first end of the tube is connected to the tapered tube opening. The body portion further includes a core. The core further includes an identification tag. The body portion further includes an identification tag. The identification tag is an RFID tag. The identification tag is an RFID that can be read by near-field communication.

[0009] According to one implementation, a connector is disclosed. The connector includes a body portion, a plug, and a tube in communication with the plug, and the plug is configured to be attached to an outlet within a disposable housing assembly.

[0010] According to a first implementation, a wearable infusion pump assembly is disclosed. The wearable infusion pump assembly includes a reservoir for receiving an injectable fluid and a fluid delivery system configured to deliver the injectable fluid from the reservoir to an external infusion set. The fluid delivery system includes a controller, a pump assembly for extracting a quantity of the injectable fluid from the reservoir and providing the quantity of the injectable fluid to the external infusion set, the pump assembly including a pump plunger having a travel distance having a start position and an end position, at least one optical sensor assembly for sensing the start and end positions of the pump plunger travel distance and transmitting a sensor output to the controller, and a first valve assembly configured to selectively isolate the pump assembly from the reservoir, the controller receiving the sensor output and determining a total displacement of the pump plunger.

[0011] Some embodiments of this implementation may include one or more of the following features. The wearable infusion pump assembly includes the controller correlating the displacement of the pump plunger with the volume of fluid delivered. The wearable infusion pump assembly includes the controller commanding the actuator to operate the pump plunger to a target position based on the volume of fluid delivered. The wearable infusion pump assembly further includes a second valve assembly configured to selectively isolate the pump assembly from an external infusion set. The wearable infusion pump assembly further includes at least one optical sensor assembly for sensing the position of the second valve assembly. The wearable infusion pump assembly further includes a disposable housing assembly including a reservoir and a first portion of the fluid delivery system, and a reusable housing assembly including a second portion of the fluid delivery system. The wearable infusion pump assembly includes the first portion of the pump assembly being positioned within the disposable housing assembly and the second portion of the pump assembly being positioned within the reusable housing assembly. The wearable infusion pump assembly includes a first portion of the first valve assembly positioned within the disposable housing assembly and a second portion of the first valve assembly positioned within the reusable housing assembly. The wearable infusion pump assembly includes a first portion of the second valve assembly positioned within the disposable housing assembly and a second portion of the second valve assembly positioned within the reusable housing assembly. The wearable infusion pump assembly includes a detachable external infusion set configured such that the external infusion set detachably engages the fluid delivery system.

[0012] According to a first implementation, a disposable housing assembly for an infusion pump assembly is disclosed. The disposable housing assembly includes a reservoir portion fluidly connected to a fluid path, the reservoir portion including a bubble trap that prevents air from moving from the reservoir portion to the fluid path. The bubble trap further includes an outlet portion and a non-outlet portion, the non-outlet portion including a tapered portion that tapers to a bottom portion, and the tapered portion of the non-outlet portion ends at the outlet portion. The bubble trap also includes a bottom portion where the outlet portion communicates with an upwardly inclined portion that is in fluid communication with a reservoir outlet, the bottom portion being configured such that fluid collects in the bottom portion, and the tapered portion being configured such that bubbles collect in the tapered portion.

[0013] Some embodiments of this implementation may include one or more of the following features. The disposable housing assembly further includes a membrane assembly that is connected to the reservoir and forms part of the reservoir. The disposable housing assembly further includes a partition assembly formed on the membrane assembly. The disposable housing assembly further includes a partition assembly connected to the reservoir. The disposable housing assembly further includes a discharge port that further includes a filter.

[0014] According to one implementation, a fluid connector assembly is disclosed. The fluid connector assembly includes a body portion, a plug receiving portion located on the body portion that includes a fluid path and is configured to receive a plug on a reservoir, and a tube, the first end of which is fluidly connected to the plug receiving portion fluid path.

[0015] Some embodiments of this implementation may include one or more of the following features. The body part further includes a recess, which is configured to interact with the reusable part of the infusion pump. The second end of the tube is connected to the cannula assembly. The body part further includes a tapered tube opening, and the first end of the tube is connected to the tapered tube opening. The first end of the body part further comprises a locking icon. The lower surface of the body part comprises a core. The core comprises an identification tag. The body part comprises an identification tag. The identification tag is an RFID tag. The identification tag is an RFID that can be read by near-field communication.

[0016] The details of one or more embodiments will be described in the following accompanying drawings and description. Other features and advantages will be apparent from the description, drawings, and claims.

Brief Description of the Drawings

[0017]

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DETAILED DESCRIPTION OF THE INVENTION

[0018] Like reference numerals in the various drawings indicate like elements.

[0019] Referring to FIGS. 1-3, the infusion pump assembly 100 may include a reusable housing assembly 102. The reusable housing assembly 102 may be constructed from any suitable material such as a rigid or stiff plastic that resists compression. For example, the use of durable materials and components may improve quality and reduce costs by providing a more long-lasting and durable reusable portion that provides excellent protection for the components disposed therein.

[0020] The reusable housing assembly 102 may include a machine control assembly 104 having a pump assembly 106 and at least one valve assembly 108. The reusable housing assembly 102 may also include an electrical control assembly 110 configured to provide one or more control signals to the machine control assembly 104 to achieve basal and / or bolus delivery of injectable fluid to the user. The disposable housing assembly 114 may include a valve assembly 108 that may be configured to control the flow rate of injectable fluid through the fluid path. The reusable housing assembly 102 may also include a pump assembly 106 that may be configured to deliver injectable fluid to the user from the fluid path.

[0021] The electrical control assembly 110 may monitor and control the amount of injectable fluid that has been delivered and / or is being delivered. For example, the electrical control assembly 110 may receive a signal from the volume sensor assembly 148, calculate the amount of injectable fluid that has just been dispensed, and determine whether sufficient injectable fluid has been dispensed based on the dosage required by the user. If sufficient injectable fluid has not been dispensed, the electrical control assembly 110 may determine that more injectable fluid should be delivered. The electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that additional required dosages can be delivered, or the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that additional dosages can be dispensed along with the next dosage. Alternatively, if excessive injectable fluid has been dispensed, the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that less injectable fluid can be dispensed in the next dosage.

[0022] The mechanical control assembly 104 may include at least one shape memory actuator 112. The pump assembly 106 and / or the valve assembly 108 of the mechanical control assembly 104 may be actuated by the shape memory actuator 112, which may be at least one shape memory actuator, such as a shape memory wire in the form of a wire or a spring. The shape memory actuator 112 may be operably connected to and activated by the electrical control assembly 110, which may control the timing and the amount of heat and / or electrical energy used to operate the mechanical control assembly 104. The shape memory actuator 112 may be, for example, a conductive shape memory alloy wire that changes shape with temperature. The temperature of the shape memory actuator 112 may be changed by a heater or, more conveniently, by the application of electrical energy. The shape memory actuator 112 may be a shape memory wire made of a nickel / titanium alloy such as NITINOL TM or FLEXINOL®.

[0023] The infusion pump assembly 100 may include a volume sensor assembly 148 configured to monitor the amount of fluid infused by the infusion pump assembly 100. For example, the volume sensor assembly 148 may employ, for example, acoustic volume sensing. Acoustic volume measurement techniques are the subject of U.S. Pat. Nos. 5,575,310 and 5,755,683, and U.S. Patent Publications Nos. US2007 / 0228071A1, US2007 / 0219496A1, 2007 / 0219480A1, US2007 / 0219597A1, which are hereby incorporated by reference in their entireties. For example, other alternative techniques for measuring flow rates may also be used, such as Doppler-based methods, the use of Hall effect sensors in combination with vanes or flapper valves, the use of strain beams (e.g., related to a flexible member covering a fluid reservoir to sense deflection of the flexible member), the use of volume sensing with plates, or time-of-flight thermal methods. One such alternative technique is disclosed in U.S. Patent Application No. 11 / 704,899 (Attorney Docket No. E70), entitled Fluid Delivery Systems and Methods, filed on Feb. 9, 2007 and published on Oct. 4, 2007 as U.S. Publication No. US-2997-0228071-A1, which is hereby incorporated by reference in its entirety. The infusion pump assembly 100 may be configured such that volume measurements generated by the volume sensor assembly 148 can be used through a feedback loop to control the amount of injectable fluid injected into the user.

[0024] The infusion pump assembly 100 may further include a disposable housing assembly 114. For example, the disposable housing assembly 114 may be configured for single use or for use over a specified period, such as, for example, three days or any other amount of time. The disposable housing assembly 114 may be configured such that any components within the infusion pump assembly 100 that contact the injectable fluid are disposed on and / or within the disposable housing assembly 114. For example, a fluid path or channel that includes a reservoir may be positioned within the disposable housing assembly 114 and may be configured for single use or for use a specified number of times prior to disposal. The disposable nature of the disposable housing assembly 114 may improve the hygiene of the infusion pump assembly 100.

[0025] Referring also to FIG. 4, the disposable housing assembly 114 may be configured to removably engage with a reusable housing assembly 102 and includes a cavity 116 having a reservoir 118 for receiving an injectable fluid (not shown), such as, for example, insulin. Such a removable engagement may be achieved, for example, by a screw-type, twist-lock, or compression fit configuration. The disposable housing assembly 114 and / or the reusable housing assembly 102 may include an alignment assembly configured to assist in aligning the disposable housing assembly 114 and the reusable housing assembly 102 for engagement in a particular orientation. Similarly, a base tab 120 and a top tab 122 may be used as indicators of alignment and complete engagement.

[0026] The cavity 116 is at least partially formed by and may be integrated with the disposable housing assembly 114. The cavity 116 may include a membrane assembly 124 for at least partially defining a reservoir 118. The reservoir 118 may be further defined by the disposable housing assembly 114, for example, by a recess 126 formed in a base portion 128 of the disposable housing assembly 114. For example, the membrane assembly 124 may be disposed to cover the recess 126 and attached to the base portion 128, thereby forming the reservoir 118. The membrane assembly 124 may be attached to the base portion 128 by conventional means such as adhesion, heat fusion, and / or compression fitting so that a seal 130 is formed between the membrane assembly 124 and the base portion 128. The membrane assembly 124 may be flexible, and the space formed between the membrane assembly 124 and the recess 126 of the base portion 128 may define the reservoir 118. The reservoir 118 may be non-pressurized and may be in fluid communication with a fluid path (not shown). The membrane assembly 124 may be at least partially crushable, and the cavity 116 may include a ventilation port assembly, thereby advantageously preventing the accumulation of a vacuum in the reservoir 118 when an injectable fluid is delivered from the reservoir 118 to the fluid path. In a preferred embodiment, the membrane assembly 124 is completely crushable, thus allowing for complete delivery of the injectable fluid. The cavity 116 may be configured to provide sufficient space to ensure that there is always some void space even when the reservoir 118 is filled with the injectable fluid.

[0027] The membranes and reservoirs described herein may be made of materials including, but not limited to, silicone, nitrile, butyl rubber, Santoprene, thermoplastic elastomer (TPE), styrene ethylene butylene styrene (SEBS), and / or any other material having the desired elasticity and properties to function as described herein. Additionally, other structures may achieve the same purpose.

[0028] The use of a partially collapsible non-pressurized reservoir can advantageously prevent the accumulation of air in the reservoir as the fluid in the reservoir is depleted. The accumulation of air in a vented reservoir can, in particular, prevent the outflow of fluid from the reservoir when the system is tilted, such that an air pocket intervenes between the fluid contained in the reservoir and the reservoir's partition walls. Tilting of the system is expected during normal operation as a wearable device.

[0029] Reservoir 118 may be sized conveniently to carry a sufficient supply of insulin for delivery over one or more days. For example, reservoir 118 may carry from about 1.00 to 3.00 ml of insulin. A 3.00 ml insulin reservoir may correspond to a supply for about three days for approximately 90% of potential users. In other embodiments, reservoir 118 may be of any size or shape and may be adapted to carry any amount of insulin or other injectable fluid. In some embodiments, the size and shape of cavity 116 and reservoir 118 are related to the type of injectable fluid that cavity 116 and reservoir 118 are adapted to carry.

[0030] Disposable housing assembly 114 may include a support member 132 (FIG. 3) configured to prevent accidental compression of reservoir 118. Compression of reservoir 118 can force an unintended dose of injectable fluid through the fluid path to the user. In a preferred embodiment, reusable housing assembly 102 and disposable housing assembly 114 may be constructed of a rigid material that is not easily compressible. However, as an additional precaution, support member 132 may be included within disposable housing assembly 114 to prevent compression of injection pump assembly 100 and cavity 116 therein. Support member 132 may be a rigid protrusion from base portion 128. For example, support member 132 may be disposed within cavity 116 and may prevent compression of reservoir 118.

[0031] As described above, the cavity 116 may be configured to provide sufficient space to ensure that there is always some void space even when the reservoir 118 is filled with the injectable fluid. Thus, if the injection pump assembly 100 is accidentally compressed, the injectable fluid cannot be forced through the cannula assembly 136 (e.g., as shown in FIG. 9).

[0032] The cavity 116 may include a septum assembly 146 (FIG. 3) configured to allow the reservoir 118 to be filled with the injectable fluid. The septum assembly 146 may be a conventional septum made of rubber or plastic and may have a one-way fluid valve configured to allow a user to fill the reservoir 118 from a syringe or other filling device. In some embodiments, the septum 146 may be located on top of the membrane assembly 124. In these embodiments, the cavity 116 may include a support structure (e.g., support member 132 in FIG. 3) for supporting the area around the back surface of the septum to maintain the integrity of the septum seal when a needle is introducing the injectable fluid into the cavity 116. The support structure may be configured to support the septum while still allowing the introduction of a needle for introducing the injectable fluid into the cavity 116.

[0033] Referring also to FIGS. 134A - 135B, an embodiment of the upper portion 2962 of the disposable housing assembly is shown. The upper portion 2962 is shown in FIG. 134A and a cross-sectional view taken at “B” is shown in FIG. 134B. A septum assembly 2964 is shown. In some embodiments, the septum assembly 2964 may include a tunnel feature that, in some embodiments, may function as a feature for pressing a needle (e.g., a filling needle) without directly pressing full force onto the septum 2966. In some embodiments, as shown in FIGS. 134A - 134C, the septum 2966 may be a separately molded component that is attached to the disposable housing assembly portion 2962 but is separated from the membrane assembly 902.

[0034] Referring now to FIGS. 135A - 135B, which are another embodiment of the partition assembly 2968, a portion of the upper part 2962 of the disposable housing assembly is shown. In this embodiment, the partition 2970 may be formed on the membrane assembly 902.

[0035] In some embodiments of the various embodiments of the partition assemblies 2964, 2968, the partitions 2970, 2976 may be at an angle of 45 degrees with respect to the upper part 2962. In some embodiments, the partitions 2970, 2976 may be made of the same material as the membrane assembly 902.

[0036] The injection pump assembly 100 may, for example, project into the cavity 116 and may include, for example, an overfill prevention assembly (not shown) that can prevent overfilling of the reservoir 118.

[0037] In some embodiments, the reservoir 118 may be configured to be filled multiple times. For example, the reservoir 118 may be refillable through the partition assembly 146. As injectable fluid is dispensed to the user, the electronic control assembly 110 may monitor the level of injectable fluid in the reservoir 118. When the level reaches a low point, the electronic control assembly 110 may provide a signal, such as light or vibration, to the user that the reservoir 118 needs to be refilled. A syringe or other filling device may be used to fill the reservoir 118 through the partition 146.

[0038] The reservoir 118 may be configured to be filled once. For example, a refill prevention assembly (not shown) may be utilized to prevent refilling of the reservoir 118 so that the disposable housing assembly 114 can be used only once. The refill prevention assembly (not shown) may be a mechanical device or an electromechanical device. For example, insertion of a syringe into the septum assembly 146 for filling the reservoir 118 may trigger a shutter to cover and close the septum 146 after one filling, thus preventing further access to the septum 146. Similarly, a sensor may indicate to the electronic control assembly 110 that the reservoir 118 has been filled once, and after one filling, trigger a shutter to cover and close the septum 146, thus preventing further access to the septum 146. Other means of preventing refilling may be utilized and are considered to be within the scope of the present disclosure.

[0039] As described above, the disposable housing assembly 114 may include a septum assembly 146 configured to allow the reservoir 118 to be filled with a fluid. The septum assembly 146 may be a conventional septum made of rubber or any other material that can function as a septum, or in other embodiments, the septum assembly 146 may be a one-way fluid valve of plastic or other material, but is not limited thereto. In various embodiments, including the exemplary embodiment, the septum assembly 146 is configured to allow a user to fill the reservoir 118 from a syringe or other filling device. The disposable housing assembly 114 may include a septum access assembly configured to limit the number of times a user may refill the reservoir 118.

[0040] For example, referring also to FIGS. 5A - 5C, the septum access assembly 152 may include a shutter assembly 154 that can be carried in an "open" position by a tab assembly 156 configured to fit within a slot assembly 158. When the filling syringe 160 penetrates the septum 146, the shutter assembly 154 may be disposed downwardly, disengaging the tab assembly 156 from the slot assembly 158. Upon disengagement, a spring assembly 162 may displace the shutter assembly 154 in the direction of arrow 164, and the septum 146 is no longer accessible to the user.

[0041] Referring also to FIG. 6A, an alternative embodiment of the septum access assembly 166 is shown in an "open" position. Similar to the septum access assembly 152, the septum access assembly 166 includes a shutter assembly 168 and a spring assembly 170.

[0042] Referring also to FIG. 6B, an alternative embodiment of the septum access assembly 172 is shown in an "open" position where a tab 178 can engage a slot 180. Similar to the septum access assembly 166, the septum access assembly 172 may include a shutter assembly 174 and a spring assembly 176. When the shutter assembly 172 moves to a "closed" position (e.g., to prevent further access to the septum 146 by the user), the tab 178 may engage at least partially with a slot 180a. The engagement between the tab 178 and the slot 180a may lock the shutter assembly 172 in the "closed" position to prevent tampering or re - opening of the shutter assembly 172. A spring tab 182 of the shutter assembly 172 may bias the tab 178 to engage the slot 180a.

[0043] However, in various embodiments, the septum access assembly may not be actuated linearly. For example, referring also to FIGS. 7A-7B, an alternative embodiment of the septum access assembly 184 is shown that includes a shutter assembly 186 configured to pivot about an axis 188. When positioned in an open position (as shown in FIG. 7A), the septum 146 may be accessible by a passageway 190 (in the shutter assembly 186) that aligns, for example, with a passageway 192 within the surface of the disposable housing assembly 114. However, similar to the septum access assemblies 166, 172, when the fill syringe 160 (see FIG. 6B) penetrates the septum 146, the shutter assembly 186 may be displaced in a clockwise direction and the passageway 190 (in the shutter assembly 186) may become misaligned with, for example, the passageway 192 within the surface of the disposable housing assembly 114, thus preventing access to the septum 146.

[0044] Referring also to FIGS. 8A-8B, an alternative embodiment of the septum access assembly 194 is shown. Similar to the septum access assemblies 166, 172, the septum access assembly 194 includes a shutter assembly 196 and a spring assembly 198 configured to bias the shutter assembly 196 in the direction of arrow 200. A fill assembly 202 may be used to fill the reservoir 118. The fill assembly 202 may include a shutter displacement assembly 204 configured to displace the shutter assembly 196 in the direction of arrow 206, which in turn aligns a passageway 208 in the shutter assembly 196 with a passageway 210 in the septum 146 and the septum access assembly 194, thus enabling a fill syringe assembly 212 to penetrate the septum 146 and the fill reservoir 118.

[0045] The infusion pump assembly 100 may include a sealing assembly 150 (FIG. 3) configured to provide a seal between a reusable housing assembly 102 and a disposable housing assembly 114. For example, when the reusable housing assembly 102 and the disposable housing assembly 114 are engaged, such as by a rotary screw engagement, a twist-lock engagement, or a compression engagement, the reusable housing assembly 102 and the disposable housing assembly 114 may fit snugly and thus form a seal. In some embodiments, it may be desirable for the seal to be more secure. Accordingly, the sealing assembly 150 may include an O-ring assembly (not shown). Alternatively, the sealing assembly 150 may include an overmolded seal assembly (not shown). The use of an O-ring assembly or an overmolded seal assembly may provide a compressible rubber or plastic layer between the reusable housing assembly 102 and the disposable housing assembly 114 when engaged, and thus may make the seal more secure by preventing penetration by external fluids. In some cases, the O-ring assembly may prevent accidental disengagement. For example, the sealing assembly 150 may be a watertight assembly and thus may enable a user to wear the infusion pump assembly 100 while swimming, bathing, or exercising.

[0046] Referring also to FIG. 9, the infusion pump assembly 100 may include an external infusion set 134 configured to deliver a fluid injectable by a user. The external infusion set 134 may be in fluid communication with the cavity 118, for example, via a fluid path. The external infusion set 134 may be disposed adjacent to the infusion pump assembly 100. Alternatively, the external infusion set 134 may be configured for application remotely from the infusion pump assembly 100, as discussed in more detail below. The external infusion set 134 may include a cannula assembly 136 that may include a needle or a disposable cannula 138, and a tube assembly 140. The tube assembly 140 may be in fluid communication with the reservoir 118, for example, through a fluid path, and with the cannula assembly 138, for example, directly or through a cannula interface 142.

[0047] As previously described with respect to remote application from the infusion pump assembly 100, the external infusion set 134 may be a tethered infusion set. For example, the external infusion set 134 may be in fluid communication with the infusion pump assembly 100 through a tube assembly 140 that may be of any length (e.g., 3 to 18 inches) desired by the user. The infusion pump assembly 100 may be worn on the user's skin by use of an adhesive patch 144, although the length of the tube assembly 140 may alternatively allow the user to wear the infusion pump assembly 100 in a pocket. This may be beneficial for users whose skin is prone to irritation by the application of the adhesive patch 144. Similarly, wearing and / or securing the infusion pump assembly 100 in a pocket may be preferable for users engaged in physical activity.

[0048] In addition to or as an alternative to the adhesive patch 144, a Velcro (registered trademark) system (such as the Velcro (registered trademark) system provided by Velcro USA Inc. (Manchester, NH), etc.) may be utilized to enable easy attachment to / removal from the user of the infusion pump assembly (e.g., infusion pump assembly 100). Thus, the adhesive patch 144 may be attached to the user's skin and may include an outward-facing hook or loop surface. Additionally, the lower surface of the disposable housing assembly 114 may include a complementary hook or loop surface. Depending on the separation resistance of the particular type of Velcro (registered trademark) system employed, it is possible that the strength of the hook and loop connection may be stronger than the strength of the adhesive for skin connection. Thus, various hook and loop surface patterns may be utilized to adjust the strength of the hook and loop connection.

[0049] Referring also to FIGS. 10A - 10E, five examples of such hook and loop surface patterns are shown. For illustrative purposes, assume that the entire lower surface of the disposable housing assembly 114 is covered with "loop" material. Thus, the strength of the hook and loop connection may be adjusted by varying the pattern (i.e., amount) of "hook" material present on the surface of the adhesive patch 144. Examples of such patterns may include a single outer circle 220 of "hook" material (as shown in FIG. 10A), multiple concentric circles 222, 224 of "hook" material (as shown in FIG. 10B), multiple radial spokes 226 of "hook" material (as shown in FIG. 10C), multiple radial spokes 228 in combination with a single outer circle 230 of "hook" material (as shown in FIG. 10D), and multiple radial spokes 232 of "hook" material in combination with multiple concentric circles 234, 236 of "hook" material (as shown in FIG. 10E), but are not limited thereto.

[0050] Additionally, referring also to FIG. 11A, in one exemplary embodiment of the infusion pump assembly described above, the infusion pump assembly 100' may be configured via a remote control assembly 300. In this particular embodiment, the infusion pump assembly 100' may include a telemetry circuit (not shown) that enables communication (e.g., wired or wireless) between the infusion pump assembly 100' and, for example, the remote control assembly 300, and thus enables the remote control assembly 300 to remotely control the infusion pump assembly 100'. The remote control assembly 300 (which may similarly include a telemetry circuit (not shown) and may be capable of communicating with the infusion pump assembly 100') may include a display assembly 302 and an input assembly 304. The input assembly 304 may include a slider assembly 306 and switch assemblies 308, 310. In other embodiments, the input assembly may include a jog wheel, multiple switch assemblies, or the like.

[0051] The remote control assembly 300 may include the ability to pre-program basal rates, bolus alarms, delivery limits, and may enable the user to view history and establish user preferences. The remote control assembly 300 may also include a glucose strip reader.

[0052] In use, the remote control assembly 300 may provide commands to the infusion pump assembly 100' via a wireless communication channel 312 established between the remote control assembly 300 and the infusion pump assembly 100'. Thus, the user may use the remote control assembly 300 to program / configure the infusion pump assembly 100'. Some or all of the communication between the remote control assembly 300 and the infusion pump assembly 100' may be encrypted to provide an enhanced level of security.

[0053] Communication between the remote control assembly 300 and the infusion pump assemblies 100' may be achieved using a standard communication protocol. Further, communication between the various components included within the infusion pump assemblies 100, 100' may be achieved using the same protocol. One example of such a communication protocol is the Packet Communication Gateway Protocol (PCGP) developed by DEKA Research & Development (Manchester, NH). As described above, the infusion pump assemblies 100, 100' may include an electrical control assembly 110 that may include one or more electrical components. For example, the electrical control assembly 110 may include a plurality of data processors (e.g., a supervisor processor and a command processor) and a wireless processor to enable the infusion pump assemblies 100, 100' to communicate with the remote control assembly 300. Further, the remote control assembly 300 may include one or more electrical components, examples of which may include, but are not limited to, a command processor and a wireless processor to enable the remote control assembly 300 to communicate with the infusion pump assemblies 100, 100'. A high-level diagram of one example of such a system is shown in FIG. 11B.

[0054] Each of these electrical components may be manufactured from different component providers and thus may utilize proprietary (i.e., unique) communication commands. Thus, efficient communication between such heterogeneous components may be achieved through the use of a standard communication protocol.

[0055] PCGP may be a flexible and extensible software module that can be used on processors within injection pump assemblies 100, 100' and remote control assembly 300 to construct and route packets. PCGP may abstract various interfaces and provide a unified application programming interface (API) to various applications running on each processor. PCGP may also provide an adaptation interface to various drivers. For illustrative purposes only, PCGP may have the conceptual structure illustrated in FIG. 11C for a given processor.

[0056] PCGP can ensure data integrity by utilizing cyclic redundancy check (CRC). PCGP can also provide a guaranteed delivery status. For example, all new messages should have a reply. If such a reply is not sent back in time, the message may time out and PCGP may generate a negative response reply message (i.e., NACK) to the application. Thus, the message reply protocol may inform the application whether the application should retry sending the message.

[0057] PCGP may also limit the number of in-flight messages from a given node, may be coupled with a flow control mechanism at the driver level to provide a deterministic approach to message delivery, and may give individual nodes different amounts of buffer without dropping packets. When the buffer at a node runs out, the driver can provide backpressure to other nodes and prevent the transmission of new messages.

[0058] PCGP may use a shared buffer pool mechanism and avoid mutual exclusion to minimize data copying, which has a slight impact on the APIs used to send / receive messages to applications and may have a greater impact on drivers. PCGP may use a "bridge" base class that provides routing and buffer ownership. The main PCGP classes may be subclassed from the bridge base class. The driver may be derived from the bridge class, communicate with or own the derived bridge class.

[0059] PCGP may be designed to operate in an embedded environment with or without an operating system by using semaphores to protect shared data so that some calls are reentrant and can operate on multiple threads. An illustrative embodiment of such an implementation is shown in FIG. 11D. PCGP may operate in the same way in both environments, but there may be versions of calls for specific processor types (e.g., ARM9 / OS version). Thus, the functionality may be the same, but there may be an operating system abstraction layer with slightly different calls, for example, suitable for the ARM9 Nucleus OS environment.

[0060] Referring also to FIG. 11E, PCGP may do the following. · Enable multiple send / receive calls to occur (on Pilot's ARM9 on multiple reentrant tasks) · Have multiple drivers that operate asynchronously for RX and TX on different interfaces · Provide packet sequencing for transmission / reception and a deterministic timeout for message transmission.

[0061] Each software object may request the buffer manager for the next buffer it uses, and then may give that buffer to another object. The buffer may be automatically passed from one exclusive owner to another, and a queue may be automatically generated by ordering the buffers by sequence number. When the buffer is no longer in use, the buffer may be recycled (e.g., an object gives the buffer to itself or releases it to the buffer manager for later reallocation). Thus, data generally need not be copied, and routing simply overwrites the buffer owner byte.

[0062] Such an implementation of PCGP may provide various benefits, and its embodiments may include, but are not limited to, the following. · Since the message may persist in the buffer until it is transferred or received by the application when it enters the buffer, message drops due to buffer lack may be impossible. · Since offsets are used to access the payload sections of the driver, PCGP, and buffer, data need not be copied. · The driver may exchange the ownership of message data by overwriting one byte (i.e., the buffer ownership byte). · Since mutual exclusion may be required only when a single buffer owner may want to use the buffer simultaneously or acquire a new sequence number, the need for multiple exclusions except for reentrant calls may not be necessary. · There may be fewer rules for application writers to follow to implement a reliable system. · Since there is a set of calls provided to push / pull data from the driver out of the buffer management system, the driver may use an ISR / push / pull / and polled data model. · The driver may not need to perform a copy, CRC, or any other check, but since the destination byte and CRC and other checks can be performed later from the ISR hot path, the driver may hardly operate except for TX and RX. · Since the buffer manager can order access by sequence number, the queue may be ordered automatically. · Small code / variable footprint may be used, that is, the hot path code can be small and the overhead can be low.

[0063] As shown in FIG. 11F, when it is necessary to send a message, the PCGP may quickly construct a packet and insert it into the buffer management system. When entering the buffer management system, the call to "packetProcessor" may apply protocol rules and give a message to the driver / application.

[0064] To send a new message or send a reply, the PCGP may do the following. · Check the call arguments, for example, to confirm that the packet length is legal, the destination is correct, etc. · Avoid attempting to send a message on a downlink that is not a wireless link, except when the downlink can enable the PCGP to be used by the wireless processor to establish a link, pair, etc., and the PCGP can notify the application when it is attempting to communicate on a non-functional link (instead of timing out). · Obtain the sequence number of a new message or use the existing sequence number of an existing message. · Construct a packet, copy the payload data and write it to the CRC, and (thereafter) the integrity of the packet can be protected by the CRC. · Provide the message to the buffer manager as a reply or new message, and check whether putting this buffer into the buffer manager exceeds the maximum number of send messages in the waiting state.

[0065] Referring also to FIGS. 11G-11H, the PCGP may operate by performing all of the main operations in one thread so as to avoid mutual exclusion and to avoid incurring significant work in send / reply or driver calls. The "packetProcessor" call may need to apply protocol rules to reply, new send messages, and received messages. The reply message may simply be sent, but new messages and received messages may have rules for sending the message. In each case, the software may loop while the correct type of message can apply the protocol rules until it is no longer possible to process the packet.

[0066] The sending of new messages may follow the following rules. · Only two messages may be the permitted "in-flight" on the network. · Sufficient data regarding the in-flight message may be stored to match responses and handle timeouts.

[0067] The receiving of messages may follow the following rules. · Since a matching response may remove the "in-flight" information slot, a new packet may be sent. · Non-matching responses may be dropped. · The new message may be for the protocol (e.g., obtaining / erasing network statistics for this node). · A buffer may be provided to the application to receive the message, and a callback may be used. · The buffer may be freed or remain owned by the application.

[0068] Therefore, the PCGP may be configured as follows. · The return function may copy the payload data out or may use it up completely before returning. · The return function may own a buffer and reference the buffer's payload by the buffer and payload address, and the message may be processed later. · The application may poll the PCGP system for received messages. · The application may use the return to set an event and then poll for received messages.

[0069] The communication system may have a limited number of buffers. When the buffers for the PCGP run out, the driver may stop receiving new packets, and the application may be informed that the application cannot send new packets. To avoid this and maintain optimal performance, the application may attempt one or more procedures, and the embodiments thereof may include, but are not limited to, the following.

[0070] a) The application should keep the PCGP up-to-date in the wireless state. Specifically, if the link goes down and the PCGP is unaware, the PCGP may receive a new message to send and put it in the queue (or may not optimally time out the message), which may interfere with the send queue and delay the application from optimally using the link.

[0071] b) The application should periodically call "decrement the timeout". Optimally, this should be done every 20 - 100 milliseconds as long as the processor is not asleep. Generally, messages move quickly (a few milliseconds), move slowly (a few seconds), or do not move at all. The timeout is an attempt to remove "in - flight" messages that should be dropped to free up buffer and bandwidth. If this is done too infrequently, it may delay the time when a new message is sent or when the application enqueues a new message.

[0072] c) The application should ask the PCGP whether there is any work to be done that is pending before going to sleep. If there is no need to do this for the PCGP, driver activity may wake up the system and thus the PCGP. Then, until a new packet enters the system, the PCGP does not need calls to "packetProcessor" or "decrement the timeout". Failure to do this may cause messages that should have been successfully sent / transferred / received to be dropped due to the timeout state.

[0073] d) The application should not hold received messages indefinitely. The message system depends on quick responses. If the application shares the PCGP buffer, holding a message means holding the PCGP buffer. The receiving node does not know whether the sending node has a timeout configured for low - speed or high - speed wireless communication. This means that when a node receives a message, it should estimate the high - speed timeout speed of the network.

[0074] e) The application should frequently call "packetProcessor". The call may cause the application to send new messages placed in the queue, or may handle the reception of new messages. The call may also cause the buffer to be reallocated. If not called frequently enough, it may delay message traffic.

[0075] As shown in Figure 11I, at some point, the RX driver may be required to receive a message from the opposite side of the interface. To ensure that the message is not dropped, the RX driver may ask the buffer manager whether there is a buffer available for storing the new message. Then, the driver may request a buffer pointer and start filling the buffer with the received data. When a complete message is received, the RX driver may call the function that routes the packet. The routing function may inspect the destination byte in the packet header, and may change the owner to another driver or application, or may detect that the packet is bad and drop the packet by releasing the buffer.

[0076] The PCGP RX overhead may consist of requesting the next available buffer and calling the routing function. An example of the code that performs such functions is as follows. @Receive request uint8 i=0, * p; if (Bridge::canReceiveFlowControl()) { p = Bridge::nextBufferRX(); while (not done) { p[i] = the next byte;} Bridge::route(p); }

[0077] The driver may perform TX by asking the buffer manager for a pointer to the next buffer to transmit. The TX driver may then ask the other side of the interface whether it can receive a packet. If the other side rejects the packet, the TX driver may not need to do anything to the buffer since its state has not changed. Otherwise, the driver may send the packet and recycle / free the buffer. An example of code that performs such a function is as follows. uint8 * p = Bridge::nextBufferTX(); if (p != (uint8 * )0) { send the buffer p; Bridge::recycle(p); }

[0078] To avoid transferring packets that have exceeded the maximum message system timeout, the buffer manager::first(uint8 owner) may be called to scan the buffers to be freed by asking for the next buffer. Thus, a complete TX buffer for which no timeout is desired may be freed on the thread that owns the buffer. The bridge that is performing TX (i.e., while looking for the next TX buffer) may free all TX buffers that will expire before receiving the next TX buffer for processing.

[0079] As shown in FIGS. 11J-11L, during the buffer allocation process, buffers marked as available may be transferred to the driver to receive new packets or to the PCGP to receive a new payload for TX. The allocation from "available" may be performed by the "packetProcessor" function. The number of transmissions and receptions during a "packetProcessor" call may determine how many LT_Driver_RX, GT_Driver_RX, and PCGP_Free buffers need to be allocated. The LT_Driver may represent a driver that handles addresses less than the node address. The GT_Driver may represent a driver that handles addresses greater than the node address.

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

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

[0082] During the call to 「packetProcessor」, the PCGP may process all buffers marked by the router as PCGP_Receive. At this point, since the data can be acted upon, CRC and other data items may be checked. If the data is corrupted, the statistic value may be incremented and the buffer may be released. Otherwise, the buffer may be marked as being owned by the application. Buffers marked as being owned by the application may be recycled for use by the RCGP or released for reallocation by the buffer manager.

[0083] When the application wants to send a new message, it may be done in a reentrant, clear / mutual exclusion manner. If a buffer can be allocated, the PCGP may mark the buffer as in use. Once marked as in use, since it is owned by the invocation of the send or reply function, none of the other threads calling this function may seize this buffer. The remainder of the process of error checking and message creation may be done outside the isolated race condition mutual exclusion protection code. The buffer may transition to an available state or become a valid filled CRC-checked buffer and be passed to the router. These buffers may not be routed immediately and may be placed in a queue to send the message later (assuming the protocol rules allow it). Reply messages may be routed with a higher priority than normal send messages, and since there may be no rules limiting how many / when they can be sent, reply messages may be marked differently from new send messages.

[0084] The PCGP is designed to be coordinated with flow control. Since there may be a lack of buffers on the opposite side of the interface (which may cause backpressure on the sending node), the flow control may negotiate for the transfer of messages from one node to another so that the buffer is never dropped.

[0085] Flow control may be part of the shared buffer format. The first two bytes may be reserved for the driver so that the driver never has to shift packet bytes. The two bytes may be used such that one byte is the DMA length - 1 and the second byte controls the flow of messages. These same two bytes may synchronize the bytes when the PCGP message is transmitted over RS232.

[0086] When the packet is "in - flight", the packet may be in the process of being sent by the driver, processed by the destination, or returned as a response while en route to its destination. Typical delays are as follows.

[0087]

Table 1

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

[0089] PCGP may use two different times (set at initialization) for all timeouts, one for when the RF link is in high - heartbeat mode and the other for when the RF link is in low - speed mode. If a message is in - flight and the link state changes from high to low, the timeout may be adjusted and the difference between high and low may be added to the expiration counter for the packet. Neither additional transitions back and forth affect the expiration of the message.

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

[0091] The PCGP messaging system may pass messages containing header information and a payload. Outside of the PCGP, the header may be a set of data items within the call signature. However, inside the PCGP, there may be a byte layout that is easy for a consistent driver to use. The driver may insert bytes into the PCGP packet or in front of the PCGP packet as follows. · DE, CA: Synchronization bytes for use with RS232, nominal values of 0xDE, 0xCA or 0x5A, 0xA5. · LD: Driver DMA length byte, equal to the amount the driver is push-delivering in this DMA transfer, the total size excluding the size byte or synchronization byte. · Cmd: Driver command and control byte used for flow control. · LP: PCGP packet length, always the total header + payload size in bytes + CRC size. LD = LP + 1. · Dst: Destination address. · Src: Source address. · Cmd: Command byte. ·Scd: Subcommand byte. ·AT: The application tag is defined by the application and has no significance to PCGP. This allows the application to attach additional information to the message, such as the thread from which the message originated. ·SeqNum: A 32-bit sequence number is incremented by PCGP for each new message sent, without wrapping around, serving as a token, and ensuring that endianness is irrelevant. ·CRC16: A 16-bit CRC for the PCGP header and payload.

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

[0093] This methodology may have several advantages, and its embodiments may include, but are not limited to, the following. ·Most of our hardware DMA engines may use the first byte to define how many additional bytes to move, so in this methodology, the driver and PCGP may share a buffer. ·A byte may be provided immediately after the DMA length to pass flow control information between drivers. ·Since the driver length and "Cmd" byte may be outside the CRC region, they may be modified by the driver, owned by the driver transport mechanism, and the driver may watch for invalid lengths. ·There may be a separate PGCP packet length byte protected by CRC. Thus, the application may rely on the correct length of its payload. · The endianness of the sequence number may be an incidental 32-bit integer or a matching byte pattern and thus may have no relevance. · The sequence number may be four bytes aligned to the edge of the shared buffer pool length. · There may be an optional RS232 synchronization byte so that if the user moves the cable around while debugging the message stream, both sides of the interface can resynchronize. · The application, driver, and PCGP may share buffers and may free them by pointer.

[0094] PCGP need not be event-driven software design, but may be used in an event-driven architecture depending on how subclasses are written. Data may be conceptually exchanged between classes (as shown in FIGS. 11M - 11N).

[0095] Some event models in the driver may start the driver, receive a message, and pass the message through a bridge into a buffer manager that sends the message to the new owner of the new message (through a bridge to the driver or PCGP). The following summarizes some exemplary events.

[0096]

Table 2

[0097] The following exemplary embodiments show how the PCGP event model may interact with Nucleus such that after decTimeout generates any transmitted message, reply, or NACK, the PCGP task is started.

[0098] class PcgpOS :public Pcgp { virtual void schedulePacketProcessor(void) { OS_EventGrp_Set(g_RCVEvGrps[EVG_RF_TASK].pEvgHandle, RfRadioTxEvent, OS_EV_OR_NO_CLEAR); } }

[0099] The following is an event - based pseudo - code driver that illustrates how the driver events operate. If the Driver sub - classifies the Bridge and disables hasMessagesToSend and flowControlTumedOff, and the TX and RX functions are not already operating, they are scheduled to operate.

[0100] class SPI_Driver :public Bridge { virtual void hasMessagesToSend() { Trigger_ISR(TX_ISR,this); } virtual void flowControlTurnedOff() { Trigger_ISR(RX_ISR,this); } static void TX_RetryTimer() { Trigger_ISR(TX_ISR,this); } static void TX_ISR(Bridge * b) { DisableISRs(); do { uint8 * p = b->nextBufferTX(); if (p == null) break; if(b->_bufferManager->bufferTimedOut(p)==false) { if(OtherSideSPI_FlowControl()==false) { TriggerTX_RetryTimerin20msec. break; } send(p); } free(p); }while(true); EnableISRs(); } staticvoidRX_ISR(Bridge*b) { DisableISRs(); do { uint8 * p = b->nextBufferRX(); if (p ==null) break; uint i; while (not done receiving) p[i++] =getChar(); b->route(p); } while (true); EnableISRs(); } }

[0101] The following statistical values may be supported by PCGP. · The number of packets sent · The number of packets received · CRC errors · Timeouts · Unavailable buffers (buffers exhausted)

[0102] The PCGP may be designed to operate in multiple processing environments. Most parameters may be configured at runtime to facilitate testing and runtime fine-tuning of performance. Other parameters may be at compile time, for example, anything that modifies memory allocation that must be done statically at compile time.

[0103] The following may be definitions of the number of compile-time configurations that can vary where the PCGP is implemented. · Driver byte count: It may be two bytes reserved for the common buffer scheme for the driver, which may be a compile-time option to adapt to other drivers such as the RF protocol. · Number of RX driver buffers: It may be tuned for how many buffers are preferred for that processor / traffic flow, etc. · Number of PCGP RX buffers: It may be tuned for how many buffers are good for that processor / traffic flow, etc. · Total number of buffers: It may be tuned for how many buffers should be in that processor.

[0104] CRC may be used to ensure data integrity. If CRC is invalid, this may not be delivered to the application, and CRC errors may be tracked. The message may eventually time out and may be retried by the sender.

[0105] Similarly, when the messaging system notifies the application that a message has been delivered when it has not, this may be dangerous for the system. A no-op command is an example of such a command. This may be mitigated by a message request / action sequence that may be required by the application to change the treatment method. The controller may receive a verification command from the pump application and consider the delivered message.

[0106] DEKA may provide a reference method for interfacing the PCGP to the Nucleus OS system on the ARM9 (as shown in FIG. 11O).

[0107] As shown in FIG. 11P, the pcgpOS.cpp file may create instances of PCGP node instances (Pcgp, Bridge, etc.) and provide a set of "C" linkable function calls through pcgpOS.h that provide a "C" language interface to the C++ code. This may simplify the fact that the "C" code is implicit as the object that receives the action.

[0108] The following general rules may apply. · The PCGP may operate on all nodes. Any driver may support the general driver interface. · Race conditions are not allowed. · Half-duplex may be supported on the SPI port between the slave and master processors. · Data transfers may not be attempted to return success or failure / false. · Low overhead (wasted time, processing, bandwidth) may be required. · The CC2510 operating at the DMA (fast) SPI clock speed may be supported.

[0109] On the receiving side, if there is currently no empty buffer for placing the packet, SPI flow control may prevent data from being sent. This may be achieved by asking for permission to send and waiting for a response indicating that permission has been given. There may also be a way to communicate to the other side that there is currently no empty buffer and that a transfer should be attempted later.

[0110] All transmissions may start with a length byte indicating the number of bytes being sent, not including the length byte itself. Following the length may be a single byte indicating the command being sent.

[0111] For the actual transmission of the packet, for the command byte, it may be the packet length plus 1, followed by the command byte for the attached message, and finally the packet itself.

[0112] In addition to the command bytes that will be transmitted, an additional hardware line called a flow control line may be added to the conventional four SPI signals. The purpose of this line is to enable the protocol to operate as quickly as possible without a preset delay. This also enables the slave processor to inform the master processor that there is a packet waiting to be transmitted, thus eliminating the need for the master processor to poll the slave processor about its status. The following exemplary command values may be used. Commands transmitted by the master processor:

[0113] [Table 3]

[0114] Commands transmitted by the slave processor

[0115] [Table 4]

[0116] As shown in FIG. 11Q, when the slave processor has a packet to send to the master processor, the slave processor may notify the master processor (by asserting the flow control line) that there is a pending packet waiting to be sent. By doing so, it may cause an IRQ on the master processor, at which point the master processor may determine when to retrieve the message from the slave processor. The retrieval of the packet may be delayed at the discretion of the master processor, and the master processor may decide to attempt to send a packet to the slave processor before retrieving it from the slave processor.

[0117] The master processor may initiate retrieval by sending an M_CTS command to the slave processor. This is repeated by sending an S_MSG_APPENDED command along with the packet itself until the slave processor responds. The flow control line may be deasserted after the packet is sent. If the M_CTS command is received by the slave processor when not expected, the M_CTS command may be ignored.

[0118] As shown in FIG. 11R, when the master processor has a packet to send to the slave processor, the master processor may initiate the transfer by sending an M_RTS command. Upon receiving the M_RTS command, if the slave processor currently has a pending transmit packet, the slave processor lowers the flow control line so that it can be reused as a transmit enable signal. The slave processor may then inform the master processor that it is in the process of preparing the SPI DMA to receive the packet, during which time the master processor may stop measuring the byte time on the bus, enabling the slave processor to finish preparing for reception.

[0119] Next, the slave processor may indicate that it is ready to receive all packets by raising the flow control line (which is being used as the CTS signal). Upon receiving the CTS signal, the master processor may subsequently transmit the M_MSG_APPENDED command along with the packet itself.

[0120] After the transfer is complete, the slave processor may lower the flow control line. If a packet was pending at the start of the transfer or if transmission occurred on the slave processor while the packet was being received, the slave processor may re-assert the flow control line indicating that there is a pending packet.

[0121] Referring again to FIG. 11A, the infusion pump assemblies 100, 100' may include a switch assembly 318 coupled to an electrical control assembly 110 (FIG. 3) that may enable a user (not shown) to perform at least one task, or in some embodiments a plurality of tasks. One exemplary embodiment of such a task is the administration of a bolus dose of an injectable fluid (e.g., insulin) without using a display assembly. The remote control assembly 300 may enable the user to activate / deactivate / configure the infusion pump assemblies 100, 100' to administer a bolus dose of insulin.

[0122] Referring also to FIG. 12A, the slider assembly 306 may be configured to at least partially enable a user to manipulate menu-based information rendered on the display assembly 302. An example of the slider assembly 306 may include a capacitive slider assembly that may be implemented using the CY8C21434-24LFXI PSOC provided by Cypress Semiconductor (San Jose, California), the design of whose operation is described in the "CSD User Module" published by Cypress Semiconductor. For example, via the slider assembly 306, the user may slide a finger in the direction of arrow 314 to bring about a highlighted portion of the information contained within the main menu 350 (shown in FIG. 12A) that is rendered on the display assembly 302 and scrolls upward. Alternatively, the user may slide a finger in the direction of arrow 316 to bring about a highlighted portion of the information contained within the main menu 350 that is rendered on the display assembly 302 and scrolls downward.

[0123] The slider assembly 306 may be configured such that, in response to the displacement of the user's finger relative to the origin 320, for example, the speed at which the highlighted portion of the main menu 350 scrolls "upward" or "downward" varies. Thus, if the user desires to scroll "upward" quickly, the user may position a finger near the top of the slider assembly 306. Similarly, if the user desires to scroll "downward" quickly, the user may position a finger near the bottom of the slider assembly 306. Additionally, if the user desires to scroll "upward" slowly, the user may position a finger slightly "upward" relative to the origin 320. Further, if the user desires to scroll "downward" slowly, the user may position a finger slightly "downward" relative to the origin 320. When an appropriate menu item is highlighted, the user may select the highlighted menu item via one or more switch assemblies 308, 310.

[0124] Referring also to FIGS. 12B - 12F, assume for illustrative purposes that the infusion pump assemblies 100, 100' are insulin pumps, and that when the switch assembly 318 is depressed by the user, a 0.20 unit bolus dose of insulin is administered. Thus, the user may use the slider assembly 306 to highlight "Bolus" within the main menu 350 rendered on the display assembly 302. The user may then use the switch assembly 308 to select "Bolus". Once selected, processing logic (not shown) within the remote control assembly 300 may render a sub - menu 352 on the display assembly 302 (as shown in FIG. 12B).

[0125] The user may then use the slider assembly 306 to highlight "Manual Bolus" within the sub - menu 352, which may be selected using the switch assembly 308. Processing logic (not shown) within the remote control assembly 300 may then render a sub - menu 354 on the display assembly 302 (as shown in FIG. 12C).

[0126] The user may then use the slider assembly 306 to highlight "Bolus: 0.0 units" within the sub - menu 354, which may be selected using the switch assembly 308. Processing logic (not shown) within the remote control assembly 300 may then render a sub - menu 356 on the display assembly 302 (as shown in FIG. 12D).

[0127] The user may then use the slider assembly 306 to adjust the "Bolus" insulin amount to "0.20 units", which may be selected using the switch assembly 308. Processing logic (not shown) within the remote control assembly 300 may then render a sub - menu 358 on the display assembly 302 (as shown in FIG. 12E).

[0128] Next, user 14 may use slider assembly 306 to highlight "Confirm", which may be selected using switch assembly 308. Next, processing logic (not shown) within remote control assembly 300 may generate an appropriate signal that may be transmitted to the aforementioned telemetry circuit (not shown) included within remote control assembly 300. Next, a telemetry circuit (not shown) included within the remote control assembly may, whenever switch assembly 318 is depressed by the user, transmit an appropriate configuration command to configure injection pump assembly 100' such that a 0.20 unit bolus dose of insulin is administered via wireless communication channel 312 established between remote control assembly 300 and injection pump assembly 100'.

[0129] Upon successful transmission of the appropriate command, the processing logic (not shown) within remote control assembly 300 may again render sub-menu 350 on display assembly 302 (as shown in FIG. 12F).

[0130] Specifically, when programmed via remote control assembly 300, the user may depress switch assembly 318 of injection pump assembly 100' to administer the aforementioned 0.20 unit bolus dose of insulin. Via the aforementioned menu system included within remote control assembly 300, the user may define the amount of insulin administered each time the user depresses switch assembly 318. This particular example specifies that one depression of switch assembly 318 is equivalent to 0.20 units of insulin, but this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other values (e.g., 1.00 unit of insulin per depression) are equally applicable.

[0131] For purposes of illustration, assume that a user desires to administer a 2.00 unit bolus dose of insulin. To activate the bolus dose administration system described above, the user may need to hold down switch assembly 318 for a defined period (e.g., 5 seconds), at which point, infusion pump assemblies 100, 100' may generate an audible signal indicating to the user that the infusion pump assemblies 100, 100' are ready to administer a bolus dose of insulin via switch assembly 318. Thus, the user may depress switch assembly 318 ten times (i.e., 2.00 units is ten 0.20 unit doses). After each time switch assembly 318 is depressed, infusion pump assemblies 100, 100' may provide an audible response to the user via an internal speaker / voice generating device (not shown). Thus, the user may first depress switch assembly 318, and infusion pump assemblies 100, 100' may in response generate a confirmation beep, thus indicating to the user that infusion pump assemblies 100, 100' have received a command for 0.20 units of insulin (in this particular embodiment). Since the desired bolus dose is 2.00 units of insulin, the user may repeat this procedure nine more times to achieve a 2.00 unit bolus dose, and infusion pump assemblies 100, 100' may generate a confirmation beep after each depression of switch assembly 318.

[0132] In this particular embodiment, the infusion pump assemblies 100, 100' are described as providing one beep each time the user presses the switch assembly 318, but this is for illustrative purposes only and not intended to be a limitation of the present disclosure. Specifically, the infusion pump assemblies 100, 100' may be configured to provide a single beep for each defined dose of insulin. As described above, one press of the switch assembly 318 may be equivalent to 0.20 units of insulin. Thus, the infusion pump assemblies 100, 100' may be configured to provide a single beep for each 0.10 units of insulin. Thus, if the infusion pump assemblies 100, 100' are configured such that one press of the switch assembly 318 is equivalent to 0.20 units of insulin, the infusion pump assemblies 100, 100' may provide two beeps to the user each time the switch assembly 318 is pressed (i.e., one for each 0.10 units of insulin).

[0133] When the user presses the switch assembly 318 on the infusion pump assembly 100' a total of 10 times, the user may simply wait for the infusion pump assemblies 100, 100' to approve the receipt of an order to administer a 2.00 unit bolus dose of insulin (as opposed to the confirmation beep received with each press of the switch assembly 318). After a defined period of time has elapsed (e.g., 2 seconds), the infusion pump assemblies 100, 100' may provide an audible confirmation to the user regarding the unit dose to be administered via the requested bolus insulin dose. For example, if the infusion pump assemblies 100, 100' are programmed by the user such that one press of the switch assembly 318 is equivalent to 0.20 units of insulin (in this example), the infusion pump assemblies 100, 100' may beep 10 times (i.e., 2.00 units is 10 doses of 0.20 units).

[0134] When providing feedback to the user regarding the unit dose administered via a bolus insulin dose, the infusion pump assemblies 100, 100' may provide a multi-frequency audible confirmation. For example, continuing with the foregoing example where 10 beeps are provided to the user, the infusion pump assemblies 100, 100' may group the beeps into groups of 5 (to facilitate easier tallying by the user), and the beeps within each group of 5 may be rendered by the infusion pump assemblies 100, 100' such that each subsequent beep has a higher frequency than the preceding beep (similar to a musical scale). Thus, continuing with the foregoing example, the infusion pump assemblies 100, 100' may render a beep at 1,000 Hz, followed by a beep at 1,100 Hz, followed by a beep at 1,200 Hz, followed by a beep at 1,300 Hz, followed by a beep at 1,400 Hz (thus completing a group of 5 beeps), followed by a short pause, then a beep at 1,000 Hz, followed by a beep at 1,100 Hz, followed by a beep at 1,200 Hz, followed by a beep at 1,300 Hz, followed by a beep at 1,400 Hz (thus completing a second group of 5 beeps). According to various additional / alternative embodiments, the multi-frequency audible confirmation may utilize various numbers of tones with incrementing frequencies. For example, an embodiment may utilize 20 different tones with incrementing frequencies. However, the number of tones may vary according to design criteria and user needs and thus should not be construed as a limitation of the present disclosure.

[0135] Once the injection pump assemblies 100, 100' complete the rendering of the multi-frequency audible confirmation (i.e., the 10 beep sounds described above), the user may press the switch assembly 318 within a defined period (e.g., 2 seconds) to provide a confirmation signal to the injection pump assemblies 100, 100', indicating that the multi-frequency audible confirmation is accurate and indicating the size of the bolus dose of insulin to be administered (i.e., 2.00 units). Upon receiving this confirmation signal, the injection pump assemblies 100, 100' may render an audible sound of "confirmation received" and (in this particular embodiment) achieve the delivery of a 2.00 unit bolus dose of insulin. If the injection pump assemblies 100, 100' do not receive the aforementioned confirmation signal, the injection pump assemblies 100, 100' may render an audible sound of "confirmation failed" and not achieve the delivery of the bolus dose of insulin. Thus, if the multi-frequency audible confirmation is not accurate / does not indicate the size of the bolus dose of insulin to be administered, the user may simply not provide the aforementioned confirmation signal, thereby aborting the delivery of the bolus dose of insulin.

[0136] As described above, in one exemplary embodiment of the infusion pump assembly described above, the infusion pump assembly 100' may be used to communicate with a remote control assembly 300. When such a remote control assembly 300 is utilized, the infusion pump assembly 100' and the remote control assembly 300 may periodically check in with each other to ensure that the two devices are still communicating with each other. For example, the infusion pump assembly 100' may send a "ping" to the remote control assembly 300 to ensure that the remote control assembly 300 is present and operating. Further, the remote control assembly 300 may send a "ping" to the infusion pump assembly 100' to ensure that the infusion pump assembly 100' is still present and operating. If either the infusion pump assembly 100' or the remote control assembly 300 is unable to establish communication with the other assembly, the assembly that cannot establish communication may sound a "separation" alarm. For example, assume that the remote control assembly 300 is left in the user's car while the infusion pump assembly 100' is in the user's pocket. Thus, after a defined period, the infusion pump assembly 100' may begin to sound a "separation" alarm, indicating that it is unable to establish communication with the remote control assembly 300. Using the switch assembly 318, the user may approve / silence this "separation" alarm.

[0137] While the remote control assembly 300 is not communicating with the infusion pump assembly 100', the user may define and administer a bolus insulin dose via the switch assembly 318 of the infusion pump assembly 100'. Therefore, the infusion pump assembly 100' may store information regarding the administered bolus insulin dose in a log file (not shown) stored within the infusion pump assembly 100'. This log file (not shown) may be stored in a non-volatile memory (not shown) included within the infusion pump assembly 100'. When communication is re-established between the infusion pump assembly 100' and the remote control assembly 300, the infusion pump assembly 100' may provide the remote control assembly 300 with information regarding the administered bolus insulin dose stored in the log file (not shown) of the infusion pump assembly 100'.

[0138] Furthermore, if the user anticipates separating the remote control assembly 300 from the infusion pump assembly 100', the user may configure the infusion pump assembly 100' and the remote control assembly 300 to enter the "separation" mode (via the aforementioned menu system), thus eliminating the occurrence of the aforementioned "separation" alarm. However, the devices may continue to "ping" each other so that the infusion pump assembly 100' and the remote control assembly 300 may automatically exit the "separation" mode when they resume communication with each other.

[0139] Furthermore, if the user anticipates traveling by aircraft, the user may configure the infusion pump assembly 100' and the remote control assembly 300 to enter the "aircraft" mode in which all data transmissions are temporarily halted for each of the infusion pump assembly 100' and the remote control assembly 300 (via the aforementioned menu system of the remote control assembly 300). During the "aircraft" mode, the infusion pump assembly 100' and the remote control assembly 300 may or may not continue to receive data.

[0140] The switch assembly 318 may be used to perform additional functions such as checking the battery life of the reusable housing assembly 102, pairing the reusable housing assembly 102 with the remote control assembly 300, and interrupting the administration of a bolus dose of injectable fluid.

[0141] Step of checking battery life: The reusable housing assembly 102 may include a rechargeable battery assembly that may be capable of powering the infusion pump assemblies 100, 100' for approximately three days (when fully charged). Such a rechargeable battery assembly may have a predetermined number of usable hours, such as a years' worth of usable life, or other predetermined length of usable time. However, the predetermined life may depend on many factors including, but not limited to, one or more of climate, daily use, and number of recharges. Whenever the reusable housing assembly 102 is disconnected from the disposable housing assembly 114, or whenever the infusion pump assemblies 100, 100' are depressed over a period defined by the switch assembly 318 (e.g., for more than two seconds), a battery check may be performed on the aforementioned rechargeable battery assembly. If the aforementioned rechargeable battery assembly is determined to be charged above a desired threshold, the infusion pump assemblies 100, 100' may render a "battery okay" tone. Alternatively, if the aforementioned rechargeable battery assembly is determined to be charged below a desired threshold, the infusion pump assemblies 100, 100' may render a "low battery" tone. The infusion pump assemblies 100, 100' may include components and / or circuitry for determining whether the reusable housing assembly 102 is disconnected from the disposable housing assembly 114.

[0142] Pairing step: As described above, in one exemplary embodiment of the injection pump assembly described above, the injection pump assembly 100' may be used to communicate with the remote control assembly 300. To achieve communication between the injection pump assembly 100' and the remote control assembly 300, a pairing process may be performed. During such a pairing process, one or more injection pump assemblies (e.g., injection pump assembly 100') may be configured to communicate with the remote control assembly 300, and (conversely) the remote control assembly 300 may be configured to communicate with one or more injection pump assemblies (e.g., injection pump assembly 100'). Specifically, the serial number of the injection pump assembly (e.g., injection pump assembly 100') may be recorded in a pairing file (not shown) included in the remote control assembly 300, and the serial number of the remote control assembly 300 may be recorded in a pairing file (not shown) included in the injection pump assembly (e.g., injection pump assembly 100').

[0143] According to an embodiment, to achieve such a pairing procedure, the user may simultaneously press one or more switch assemblies on both the remote control assembly 300 and the injection pump assembly 100'. For example, the user may simultaneously press the switch assembly 310 included in the remote control assembly 300 and the switch assembly 318 included in the injection pump assembly 100' over a defined period, such as for more than 5 seconds. When this defined period is reached, one or more of the remote control assembly 300 and the injection pump assembly 100' may generate an audible signal indicating that the aforementioned pairing procedure has been achieved.

[0144] According to another embodiment, before performing the pairing process, the user may disconnect the reusable housing assembly 102 from the disposable housing assembly 114. By requiring this initial step, further assurance is provided that the infusion pump assembly worn by the user cannot be improperly paired with the remote control assembly.

[0145] Once disconnected, the user may enter the pairing mode via the input assembly 304 of the remote control assembly 300. For example, the user may enter the pairing mode on the remote control assembly 300 via the aforementioned menu system in combination with, for example, the switch assembly 310. The user may be instructed on the display assembly 302 of the remote control assembly 300 to long-press the switch assembly 318 on the infusion pump assembly 100'. Additionally, the remote control assembly 304 may switch to a low power mode, for example, to avoid attempting to pair with a remote infusion pump assembly. The user may then long-press the switch assembly 318 on the infusion pump assembly 100' such that the infusion pump assembly 100' enters the receiving mode and waits for a pairing command from the remote control assembly 300.

[0146] The remote control assembly 300 may then transmit a pairing request to the infusion pump assembly 100', which may be approved by the infusion pump assembly 100'. The infusion pump assembly 100' may perform a security check on the pairing request received from the remote control assembly 300, and (if the security check passes) the infusion pump assembly 100' may activate a pump pairing signal (i.e., enter the active pairing mode). The remote control assembly 300 may perform a security check on the approval received from the infusion pump assembly 100'.

[0147] The authorization received from the infusion pump assembly 100' may define the serial number of the infusion pump assembly 100', and the remote control assembly 300 may display that serial number on the display assembly 302 of the remote control assembly 300. The user may be asked whether they desire to pair with the found pump. If the user declines, the pairing process may be interrupted. If the user consents to the pairing process, the remote control assembly 300 may instruct the user (via the display assembly 302) to long-press the switch assembly 318 on the infusion pump assembly 100'.

[0148] The user may then long-press the switch assembly 318 on the infusion pump assembly 100' and, for example, long-press the switch assembly 310 on the remote control assembly 300.

[0149] The remote control assembly 300 may confirm that the remote switch assembly 310 has been pressed (which may be reported to the infusion pump assembly 100'). The infusion pump assembly 100' may perform a security check on the confirmation received from the remote control assembly 300 to verify the integrity of the confirmation. If the integrity of the received confirmation is not proven, the pairing process is interrupted. If the integrity of the received confirmation is proven, any existing remote pairing configuration file is overwritten to reflect the newly paired remote control assembly 300, a pump pairing completion signal is activated, and the pairing process is completed.

[0150] In addition, the infusion pump assembly 100' may confirm that the switch assembly 318 has been depressed (which may be reported to the remote control assembly 300). The remote control assembly 300 may perform a security check on the confirmation received from the infusion pump assembly 100' to confirm the integrity of the confirmation. If the integrity of the received confirmation is not proven, the pairing process is interrupted. If the integrity of the received confirmation is proven, the pair list file in the remote control assembly 300 may be modified to add the infusion pump assembly 100'. Typically, while the remote control assembly 300 may be capable of pairing with multiple infusion pump assemblies, the infusion pump assembly 100' may only be capable of pairing with a single remote control assembly. A pairing completion signal may be activated and the pairing process may be completed.

[0151] When the pairing process is complete, one or more of the remote control assembly 300 and the infusion pump assembly 100' may generate an audible signal indicating that the pairing procedure described above has been successfully achieved.

[0152] Step of interrupting the bolus dose: If the user desires to discontinue, for example, the bolus dose of insulin being administered by the infusion pump assembly 100', the user may depress the switch assembly 318 (shown, for example, in FIGS. 1 and 2) for a defined period exceeding, for example, 5 seconds. Upon reaching this defined period, the infusion pump assembly 100' may render an audible signal indicating that the above-described discontinuation procedure has been achieved.

[0153] The switch assembly 318 is shown as being positioned on top of the infusion pump assemblies 100, 100', but this is for illustrative purposes only and is not intended to be limiting of the present disclosure since other configurations are possible. For example, the switch assembly 318 may be positioned around the infusion pump assemblies 100, 100'.

[0154] Referring also to FIGS. 13 - 15, an injection pump assembly 400 of an alternative embodiment is shown. Similar to the pump assemblies 100, 100', the injection pump assembly 400 may include a reusable housing assembly 402 and a disposable housing assembly 404.

[0155] Similar to the reusable housing assembly 102, the reusable housing assembly 402 may include a mechanical control assembly (including at least one pump assembly and at least one valve assembly). The reusable housing assembly 402 may also include an electrical control assembly configured to provide control signals to the mechanical control assembly to achieve delivery of injectable fluid to the user. The valve assembly may be configured to control the flow rate of injectable fluid through the fluid path, and the pump assembly may be configured to deliver injectable fluid from the fluid path to the user.

[0156] Similar to the disposable housing assembly 114, the disposable housing assembly 404 may be configured for single use or for use over a specified period, such as, for example, three days or any other amount of time. The disposable housing assembly 404 may be configured such that any components within the injection pump assembly 400 that contact the injectable fluid are disposed on and / or inside the disposable housing assembly 404.

[0157] In certain embodiments of the present infusion pump assembly, the infusion pump assembly 400 may include a switch assembly 406 positioned peripherally to the infusion pump assembly 400. For example, the switch assembly 406 may be positioned along a radial edge of the infusion pump assembly 400, which may enable easier use by a user. The switch assembly 406 may be covered with a waterproof membrane configured to prevent ingress of water into the infusion pump assembly 400. The reusable housing assembly 402 may include a main body 408 (which houses the aforementioned mechanical and electrical control assemblies) and a locking ring assembly 410 configured to rotate around the main body 408 (in the direction of arrow 412).

[0158] Similar to the reusable housing assembly 102 and the disposable housing assembly 114, the reusable housing assembly 402 may be configured to removably engage with the disposable housing assembly 404. Such a removable engagement may be achieved, for example, by a screw-type, twist-lock, or compression fit configuration. In embodiments where a twist-lock configuration is utilized, a user of the infusion pump assembly 400 may first properly position the reusable housing assembly 402 relative to the disposable housing assembly 404 and then rotate the locking ring assembly 410 (in the direction of arrow 412) to removably engage the reusable housing assembly 402 with the disposable housing assembly 404.

[0159] Through the use of the locking ring assembly 410, the reusable housing assembly 402 is properly positioned relative to the disposable housing assembly 404 and may then be releasably engaged by rotating the locking ring assembly 410, thus eliminating the need to rotate the reusable housing assembly 402 relative to the disposable housing assembly 404. Thus, the reusable housing assembly 402 may be properly aligned with the disposable housing assembly 404 prior to engagement, and such alignment must not be disrupted during the engagement process. The locking ring assembly 410 may include a latching mechanism (not shown) that can prevent rotation of the locking ring assembly 410 until the reusable housing assembly 402 and the disposable housing assembly 404 are properly positioned relative to each other.

[0160] Referring also to FIGS. 16 - 18, an injection pump assembly 500 of an alternative embodiment is shown. Similar to the pump assemblies 100, 100', the injection pump assembly 500 may include a reusable housing assembly 502 and a disposable housing assembly 504.

[0161] Similar to the reusable housing assembly 402, the reusable housing assembly 502 may include a mechanical control assembly (including at least one pump assembly and at least one valve assembly). The reusable housing assembly 502 may also include an electrical control assembly configured to provide control signals to the mechanical control assembly to achieve delivery of injectable fluid to the user. The valve assembly may be configured to control the flow rate of injectable fluid through the fluid path, and the pump assembly may be configured to deliver injectable fluid from the fluid path to the user.

[0162] Similar to the disposable housing assembly 404, the disposable housing assembly 504 may be configured for single use or for use over a specified period, such as, for example, three days or any other amount of time. The disposable housing assembly 504 may be configured such that any components within the infusion pump assembly 500 that contact the injectable fluid are disposed on and / or inside the disposable housing assembly 504.

[0163] In certain embodiments of this infusion pump assembly, the infusion pump assembly 500 may include a switch assembly 506 positioned peripherally about the infusion pump assembly 500. For example, the switch assembly 506 may be positioned along a radial edge of the infusion pump assembly 500, which may allow for easier use by the user. The switch assembly 506 may be covered with a waterproof membrane and / or an O-ring, or alternatively, a sealing mechanism may be included over a handle 507 of the switch assembly 506 configured to prevent water ingress into the infusion pump assembly 500. However, in some embodiments, the switch assembly 506 may include an overmolded rubber button and thus may provide functionality as a waterproof seal without using a waterproof membrane or an O-ring. However, in still other embodiments, the overmolded rubber button may additionally be covered with a waterproof membrane and / or include an O-ring. The reusable housing assembly 502 may include a main body 508 (which houses the aforementioned mechanical and electrical control assemblies) and a locking ring assembly 510 that may be configured to rotate about the main body 508 (in the direction of arrow 512).

[0164] Similar to the reusable housing assembly 402 and the disposable housing assembly 404, the reusable housing assembly 502 may be configured to removably engage with the disposable housing assembly 504. Such a removable engagement may be achieved, for example, by a screw-type, twist-lock, or compression fit configuration. In an embodiment where a twist-lock configuration is utilized, the user of the infusion pump assembly 500 may first properly position the reusable housing assembly 502 relative to the disposable housing assembly 504 and then rotate the locking ring assembly 510 (in the direction of arrow 512) to removably engage the reusable housing assembly 502 with the disposable housing assembly 404.

[0165] Since the locking ring assembly 510 included within the infusion pump assembly 500 may be higher than the locking ring assembly 410 (i.e., as shown by arrow 514), the locking ring assembly 510 may include a passageway 516 through which the button 506 can pass. Thus, when assembling the reusable housing assembly 502, the locking ring assembly 510 may be installed over the main body 508 (in the direction of arrow 518). When the locking ring assembly 510 is installed over the main body 508, one or more locking tabs (not shown) may prevent the locking ring assembly 510 from being removed from the main body 508. Next, the portion of the switch assembly 506 protruding through the passageway 516 may be pushed into the main body 508 (in the direction of arrow 520), and thus, the installation of the switch assembly 506 may be completed.

[0166] The button 506 is shown at various locations on the infusion pump assembly 500, but in other embodiments, the button 506 may be located at any desired location on the infusion pump assembly 500.

[0167] Through the use of the retaining ring assembly 510, the reusable housing assembly 502 is properly positioned relative to the disposable housing assembly 504 and then releasably engaged by rotating the retaining ring assembly 510, thus eliminating the need to rotate the reusable housing assembly 502 relative to the disposable housing assembly 504. Thus, the reusable housing assembly 502 may be properly aligned with the disposable housing assembly 504 prior to engagement, and such alignment must not be disrupted during the engagement process. The retaining ring assembly 510 may include a latching mechanism (not shown) that prevents rotation of the retaining ring assembly 510 until the reusable housing assembly 502 and the disposable housing assembly 504 are properly positioned relative to each other. The passageway 516 may be elongate to allow movement of the retaining ring 510 around the switch assembly 506.

[0168] Referring also to FIGS. 19A-19B and 20-21, various views of the infusion pump assembly 500 are shown, including the reusable housing assembly 502, the switch assembly 506, and the main body 508. As described above, the main body 508 may include a plurality of components, examples of which include, but are not limited to, the volume sensor assembly 148, the printed circuit board 600, the vibration motor assembly 602, the shape memory actuator anchor 604, the switch assembly 506, the battery 606, the antenna assembly 608, the pump assembly 106, the metering valve assembly 610, the volume sensor valve assembly 612, and the reservoir valve assembly 614. For purposes of clarity, the printed circuit board 600 has been removed from FIG. 19B to allow visualization of the various components positioned beneath the printed circuit board 600.

[0169] Various electrical components that can be electrically coupled to the printed circuit board 600 may utilize spring-biased terminals that enable electrical coupling without the need for soldering connections. For example, the vibration motor assembly 602 may utilize a pair of spring-biased terminals (one positive terminal and one negative terminal) configured to press against corresponding conductive pads on the printed circuit board 600 when the vibration motor assembly 602 is positioned on the printed circuit board 600. However, in the exemplary embodiment, the vibration motor assembly 602 is soldered directly to the printed circuit board.

[0170] As described above, the volume sensor assembly 148 may be configured to monitor the amount of fluid injected by the injection pump assembly 500. For example, the volume sensor assembly 148 may employ acoustic volume sensing, which is the subject of U.S. Pat. Nos. 5,575,310 and 5,755,683, and U.S. Patent Publications Nos. US2007 / 0228071A1, US2007 / 0219496A1, 2007 / 0219480A1, US2007 / 0219597A1, all of which are incorporated herein by reference in their entirety.

[0171] The vibration motor assembly 602 may be configured to provide a vibration-based signal to a user of the infusion pump assembly 500. For example, when the voltage of the battery 606 (which powers the infusion pump assembly 500) drops below a minimum allowable voltage, the vibration motor assembly 602 may vibrate the infusion pump assembly 500 to provide a vibration-based signal to the user of the infusion pump assembly 500. The shape memory actuator anchor 604 may provide a mounting point for the aforementioned shape memory actuator (e.g., shape memory actuator 112). As previously described, the shape memory actuator 112 may be, for example, a conductive shape memory alloy wire that changes shape with temperature. The temperature of the shape memory actuator 112 may be changed by a heater or, more conveniently, by the application of electrical energy. Accordingly, one end of the shape memory actuator 112 may be firmly attached (i.e., tethered) to the shape memory actuator anchor 604, and the other end of the shape memory actuator 112 may be applied to, for example, a valve assembly and / or a pump actuator. Accordingly, by applying electrical energy to the shape memory actuator 112, the length of the shape memory actuator 112 may be controlled, and thus, the valve assembly and / or pump actuator to which it is attached may be operated.

[0172] The antenna assembly 608 may be configured to enable wireless communication, for example, between the infusion pump assembly 500 and the remote control assembly 300 (FIG. 11). As described above, the remote control assembly 300 may enable a user to program the infusion pump assembly 500, for example, to configure a bolus infusion event. As described above, the infusion pump assembly 500 may include one or more valve assemblies configured to control the flow rate of an injectable fluid through a fluid path (within the infusion pump assembly 500), and the pump assembly 106 may be configured to deliver the injectable fluid from the fluid path to the user. In a particular embodiment of this infusion pump assembly 500, the infusion pump assembly 500 is shown to include three valve assemblies, namely, a measurement valve assembly 610, a volume sensor valve assembly 612, and a reservoir valve assembly 614.

[0173] As described above and also referring to FIG. 21, the injectable fluid may be stored within the reservoir 118. To achieve delivery of the injectable fluid to the user, processing logic (not shown) included within the infusion pump assembly 500 may energize the shape memory actuator 112 that can be moored onto one end using the shape memory actuator anchor 604. Referring also to FIG. 22A, the shape memory actuator 112 may effect activation of the pump assembly 106 and the reservoir valve assembly 614. The reservoir valve assembly 614 may include a reservoir valve actuator 614A and a reservoir valve 614B, and activation of the reservoir valve assembly 614 may effect downward displacement of the reservoir valve actuator 614A and closure of the reservoir valve 614B, which may effect isolation of the reservoir 118. Further, the pump assembly 106 may include a pump plunger 106A and a pump chamber 106B, and activation of the pump assembly 106 may effect downward displacement of the pump plunger 106A into the pump chamber 106B, which may effect displacement of the injectable fluid (in the direction of arrow 616).

[0174] The volume sensor valve assembly 612 may include a volume sensor valve actuator 612A and a volume sensor valve 612B. Referring also to FIG. 22B, the volume sensor valve actuator 612A may be closed via a spring assembly that provides a mechanical force to seal the volume sensor valve 612B. However, when the pump assembly 106 is activated, if the displaced injectable fluid is at a pressure sufficient to overcome the mechanical sealing force of the volume sensor valve assembly 612, the displacement of the injectable fluid occurs in the direction of arrow 618. This can result in the filling of the volume sensor chamber 620 contained within the volume sensor assembly 148. Through the use of the speaker assembly 622, the port assembly 624, the reference microphone 626, the spring diaphragm 628, and the constant volume microphone 630, the volume sensor assembly 148 may determine the dose of injectable fluid contained within the volume sensor chamber 620.

[0175] Referring also to FIG. 22C, when the volume of injectable fluid contained within the volume sensor chamber 620 is calculated, the shape memory actuator 632 may be energized, resulting in the activation of the measurement valve assembly 610, which may include a measurement valve actuator 610A and a measurement valve 610B. When activated, and by the mechanical energy exerted on the injectable fluid within the volume sensor chamber 620 by the spring diaphragm 628, the injectable fluid within the volume sensor chamber 620 may be displaced into the user's body (in the direction of arrow 634) through the disposable cannula 138.

[0176] Referring also to FIG. 23, an exploded view of the infusion pump assembly 500 is shown. The shape memory actuator 632 may be tethered to the shape memory actuator anchor 636 (at the first end). Additionally, the other end of the shape memory actuator 632 may be used to provide mechanical energy to the valve assembly 638, which may activate the metering valve assembly 610. The volume sensor assembly spring retainer 642 may properly position the volume sensor assembly 148 relative to various other components of the infusion pump assembly 500. The valve assembly 638 may be used in conjunction with the shape memory actuator 112 to activate the pump plunger 106A. The metering valve 610B, the volume sensor valve 612B, and / or the reservoir valve 614B may be built-in valves configured to allow installation during assembly of the infusion pump assembly 500 by pushing the valve upward into the lower surface of the main body 508.

[0177] Referring also to FIGS. 24 and 25A - 25D, a more detailed view of the pump assembly 106 is shown. The pump actuator assembly 644 may include a pump actuator support structure 646, a biasing spring 648, and a lever assembly 650.

[0178] Referring also to FIGS. 26A - 26B and FIGS. 27A - 27B, a more detailed view of the metering valve assembly 610 is shown. As described above, the valve assembly 638 may activate the metering valve assembly 610.

[0179] Referring also to FIGS. 28A - 28D, the injection pump assembly 500 may include a metering valve assembly 610. As described above, the valve assembly 638 may be actuated via the shape memory actuator 632 and the actuator assembly 640. Thus, in order to inject the volume of injectable fluid stored within the volume sensor chamber 620, the shape memory actuator 632 may need to actuate the valve assembly 638 over a fairly long period (e.g., one minute or more). Since this consumes a significant amount of power from the battery 606, the metering valve assembly 610 may allow for a temporary actuation of the valve assembly 638, at which point the metering valve latch 656 may prevent the valve assembly 638 from returning to its non - actuated position. The shape memory actuator 652 may be tethered on the first end using the electrical contact 654. The other end of the shape memory actuator 652 may be connected to the valve latch 656. When the shape memory actuator 652 is actuated, the shape memory actuator 652 may pull the valve latch 656 forward and release the valve assembly 638. Thus, the metering valve assembly 610 may be actuated via the shape memory actuator 632. When the metering valve assembly 610 is actuated, the valve latch 656 may automatically latch the valve assembly 638 in the actuated position. By operating the shape memory actuator 652, the valve latch 656 may be pulled forward and the valve assembly 638 may be released. Assuming that the shape memory actuator 632 is no longer actuated, when the valve latch 656 releases the valve assembly 638, the metering valve assembly 610 will be in an inoperative state. Thus, through the use of the metering valve assembly 610, the shape memory actuator 632 does not need to be actuated for the entire time it takes to inject the volume of injectable fluid stored within the volume sensor chamber 620.

[0180] As described above, the aforementioned infusion pump assembly (e.g., infusion pump assemblies 100, 100', 400, 500) may include an external infusion set 134 configured to deliver injectable fluid to a user. The external infusion set 134 may include a cannula assembly 136 that may include a needle or a disposable cannula 138, and a tube assembly 140, which may also be referred to as a tubing set. The tube assembly 140 may be in fluid communication with the reservoir 118 and, for example, directly or through a cannula interface 142, with the cannula assembly 138, for example, through a fluid path.

[0181] Referring also to FIG. 29, an alternative embodiment of an infusion pump assembly 700 is shown that is configured to store a portion of the tube assembly 140. Specifically, the infusion pump assembly 700 may include a peripheral tube storage assembly 702 configured to allow a user to wind a portion of the tube assembly 140 around the periphery of the infusion pump assembly 700 (similar to winding a yo-yo). The peripheral tube storage assembly 702 may be positioned around the periphery of the infusion pump assembly 700. The peripheral tube storage assembly 702 may be configured as an open trough into which a portion of the tube assembly 140 may be wound. Alternatively, the peripheral tube storage assembly 702 may include one or more split portions 704, 706 that form a plurality of narrower troughs sized to create an interference fit between the walls of the narrower troughs and the outer surface of a portion of the tube 140. When the peripheral tube storage assembly 705 includes the plurality of split portions 704, 706, the resulting narrower troughs may be wound in a helical pattern around the periphery of the infusion pump assembly 700 (similar to the threads of a screw).

[0182] Referring also to FIGS. 30-31, an alternative embodiment injection pump assembly 750 is shown that is configured to store a portion of the tube assembly 140. Specifically, the injection pump assembly 750 may include a peripheral tube storage assembly 752 that is configured to allow a user to wind a portion of the tube assembly 140 around the injection pump assembly 750 (again, similar to a yo-yo). The peripheral tube storage assembly 752 may be positioned around the injection pump assembly 750. The peripheral tube storage assembly 752 may be configured as an open valley portion into which a portion of the tube assembly 140 can be wound. Alternatively, the peripheral tube storage assembly 752 may include one or more split portions 754, 756 that form a plurality of narrower valleys that may be sized to create an interference fit between the walls of the narrower valleys and the outer surface of a portion of the tube 140. When the peripheral tube storage assembly 752 includes the plurality of split portions 754, 756, the resulting narrower valleys may be wound in a helical manner around the injection pump assembly 750 (again, similar to the threads of a screw).

[0183] The injection pump assembly 750 may include a tube retainer assembly 758. The tube retainer assembly 758 may be configured to removably secure the tube assembly 140 so as to prevent the tube assembly 140 from unwinding from around the injection pump assembly 750. In one embodiment of the tube retainer assembly 758, the tube retainer assembly 758 may include a downwardly directed pin assembly 760 positioned above an upwardly directed pin assembly 762. The combination of the pin assemblies 760, 762 may define a “pinch point” through which the tube assembly 140 may be pushed. Thus, a user may wind the tube assembly 140 around the injection pump assembly 750, and each loop of the tube assembly 140 is secured within the peripheral tube storage assembly 752 via the tube retainer assembly 758. If the user desires to lengthen the unsecured portion of the tube assembly 140, the user may release one loop of the tube assembly 140 from the tube retainer assembly 758. Conversely, if the user desires to shorten the unsecured portion of the tube assembly 140, the user may secure an additional loop of the tube assembly 140 within the tube retainer assembly 758.

[0184] Referring also to FIGS. 32 - 33, an exemplary embodiment of an injection pump assembly 800 is shown. Similar to the injection pump assemblies 100, 100', 400, and 500, the injection pump assembly 800 may include a reusable housing assembly 802 and a disposable housing assembly 804.

[0185] Referring also to FIGS. 34A - 34B, similar to the injection pump assembly 100, the reusable housing assembly 802 may be configured to removably engage with the disposable housing assembly 804. Such a removable engagement may be achieved, for example, by a screw-type, twist-lock, or compression fit configuration. The injection pump assembly 800 may include a locking ring assembly 806. For example, the reusable housing assembly 802 may be properly positioned relative to the disposable housing assembly, and the locking ring assembly 806 may be rotated to removably engage the reusable housing assembly 802 and the disposable housing assembly 804.

[0186] The locking ring assembly 806 may include a nub 808 having a spring-actuated tab 2980 that can facilitate rotation of the locking ring assembly 806. Additionally, for example, the position of the nub 808 relative to a tab 810 of the disposable housing assembly 804 can provide proof that the reusable housing assembly 802 is fully engaged with the disposable housing assembly 804. For example, as shown in FIG. 34A, when the reusable housing assembly 802 is properly aligned with the disposable housing assembly 804, the nub 808 can be aligned with the tab 810 in a first position. Upon achieving a fully engaged state, the rotating locking ring assembly 806 can align the nub 808 with the tab 810 in a second position, as shown in FIG. 34B.

[0187] Referring also to FIGS. 35A - 35C and FIGS. 36 - 38A, similar to the reusable housing assembly 102, the reusable housing assembly 802 may include a machine control assembly 812 (e.g., may include a valve assembly 814 shown in FIG. 36, including one or more valves and one or more pumps for delivering and controlling the flow rate of an injectable fluid). The reusable housing assembly 802 may also include an electrical control assembly 816 configured to provide control signals to the machine control assembly 812 to achieve delivery of the injectable fluid to the user. The valve assembly 814 may be configured to control the flow rate of the injectable fluid through the fluid path, and the pump assembly may be configured to deliver the injectable fluid from the fluid path to the user.

[0188] The machine control assembly 812 and the electrical control assembly 816 may be contained within a housing defined by a substrate 818 and a body 820. In some embodiments, one or more of the substrate 818 and the body 820 may provide electromagnetic shielding. In such embodiments, the electromagnetic shielding may prevent and / or reduce electromagnetic interference received and / or generated by the electrical control assembly 816. Additionally / alternatively, as shown in FIGS. 36 and 37, an EMI shield 822 may be included. The EMI shield 822 may provide shielding against electromagnetic interference generated and / or received.

[0189] The reusable housing assembly 802 may include a switch assembly configured to receive user commands (e.g., for bolus delivery, pairing with a remote control assembly, or the like). The switch assembly may include a button 824 that may be disposed in an opening 826 of the body 820. For example, as shown in FIG. 35B, the locking ring assembly 806 may include a radial slot 828 configured to allow the locking ring assembly 806 to be rotated relative to the body 820 while still providing easy access to the button 824.

[0190] Referring also to FIGS. 39A - 39C, the electrical control assembly 816 may include a printed circuit board 830 and a battery 832. The printed circuit board 830 may include various control electronics for monitoring and controlling the amount of injectable fluid that has been delivered and / or is being delivered. For example, the electrical control assembly 816 may measure the amount of injectable fluid that has just been dispensed and determine whether sufficient injectable fluid has been dispensed based on the dose required by the user. If sufficient injectable fluid has not been dispensed, the electrical control assembly 816 may determine that more injectable fluid should be delivered. The electrical control assembly 816 may provide an appropriate signal to the mechanical control assembly 812 so that additional required doses can be delivered, or the electrical control assembly 816 may provide an appropriate signal to the mechanical control assembly 812 so that additional doses can be dispensed along with the next dose. Alternatively, if excessive injectable fluid has been dispensed, the electrical control assembly 816 may provide an appropriate signal to the mechanical control assembly 812 so that less injectable fluid can be dispensed along with the next dose. The electrical control assembly 816 may include one or more microprocessors. In an exemplary embodiment, the electrical control assembly 816 may include three processors. One processor (which may include, but is not limited to, a CC2510 microcontroller / RF transceiver available from Chipcon AS (Oslo, Norway)) may be dedicated to wireless communication, for example, to communicate with a remote control assembly. Two additional microprocessors (examples of which may include, but are not limited to, an MSP430 microcontroller available from Texas Instruments Inc. (Dallas, Texas)) may be dedicated to issuing and executing commands (such as, for example, processing feedback signals from a volume measurement device that dispenses a dose of injectable fluid and performing equivalents).

[0191] As shown in FIG. 35C, the substrate 818 may provide access to electrical contacts 834 that may be electrically coupled to the electrical control assembly 816, for example, to recharge the battery 832. The substrate 818 may include one or more features (e.g., openings 836, 838) configured to facilitate proper alignment with the disposable housing assembly 804 through cooperative features (e.g., tabs) of the disposable housing assembly 804. Additionally, as shown in FIGS. 40A - 40C, 41A - 41B, and 42A - 42C, the substrate 818 may carry the valve assembly 814 and the electrical control assembly 816 and may include various features for providing access to the disposable housing assembly 804 by the valve assembly 814.

[0192] The locking ring assembly 806 may include gripping inserts 840, 842 that may be made of an elastomeric or textured material, for example, to facilitate gripping and twisting of the locking ring assembly 806 to engage / disengage the reusable housing assembly 802 and the disposable housing assembly 804. Additionally, the locking ring assembly 806 may include sensing components (e.g., magnet 844) that may interact with components of the reusable housing assembly 802 (e.g., Hall effect sensor) to provide, for example, an indication of the nature of the mating components (e.g., in some embodiments, one or more of the disposable housing assembly 804, the charging station, or the filling station, but not limited thereto) and / or whether the reusable housing assembly 802 is properly engaged with the mating components. In an exemplary embodiment, a Hall effect sensor (not shown) may be located on the pump printed circuit board. The Hall effect sensor may detect when the locking ring has been rotated to the closed position. Thus, the Hall effect sensor, together with the magnet 844, may provide a system for determining whether the locking ring has been rotated to the closed position.

[0193] The sensing component (magnet) 844 may operate to provide a determination as to whether a reusable housing assembly component, i.e., in an exemplary embodiment, together with a Hall effect sensor, is properly attached to a component or device for which the reusable housing assembly is intended. The locking ring assembly 806 shall not rotate without being attached to a component, i.e., the disposable housing assembly 804, the dust cover, or the charger. Thus, the sensing component, 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. If the system does not detect that it is attached to a disposable assembly, a dust cover, or a charger, the reusable parts, e.g., valves and pump components, may be susceptible to contamination or damage that may compromise the integrity of the reusable assembly, so the system may notify, alert, or alarm the user. Thus, the system may provide an integrity alarm to alert the user about a potential threat to the integrity of the reusable assembly. Also, if the system senses that the reusable assembly is attached to the dust cover, the system may turn off or reduce the power to conserve power. This may provide for more efficient use of power when the reusable assembly is not connected to components that need to interact.

[0194] Referring also to FIGS. 136 - 139, in some embodiments, in addition to the sensing component, a mechanical audible or "click" indicator may indicate that the reusable housing assembly 2972 is fully attached to the disposable housing assembly 2976. In some embodiments, for example, in FIG. 38A, the latching mechanism shown and described above may include a spring 2982 actuated tab 2980 assembly. In some embodiments, the tab 2980 includes a sensing component which, in some embodiments, may be a magnet 2986. Referring also to FIG. 137, a cross - sectional view at "A" of the reusable housing assembly 2972 above the disposable housing assembly 2974 in the "unlatch" position is shown. In some embodiments, the "latch" and "unlatch" positions may also be visually indicated to the user / patient using icons 2976, 2978 that may be molded, etched, and / or printed on the disposable housing assembly 2974 to indicate whether the reusable housing assembly 2972, or in some embodiments the fill adapter, is in a latched or unlatched relationship with the disposable housing assembly 2974 (or in some embodiments, the same or similar icons may appear on the dust cover). In various embodiments, the icons 2976, 2978 may be in any form that can indicate "latch" and "unlatch" or similar indicators to assist the user / patient in understanding the orientation / position between the reusable housing assembly 2972 and the disposable housing assembly 2974 (or dust cover). As shown, the reusable housing assembly 2972 is aligned with respect to the disposable housing assembly 2974 in the unlatch orientation. Referring also to FIG. 138, a cross - sectional view at "A" of the reusable housing assembly 2972 attached to the disposable housing assembly 2974 in the unlatch orientation / position is shown. The tab 2080 is in the unlatch position. Referring now to FIG. 139, a cross - sectional view at "A" of the reusable housing assembly 2972 attached to the disposable housing assembly 2974 in the latch orientation / position is shown. As can be seen in the figure, the tab 2980 is moving towards the disposable housing assembly 2974 leaving a space 2984 above the tab 2980 within the reusable housing assembly 2972.When the tab 2980 moves from the unlocked position (shown in FIG. 138) to the locked position (shown in FIG. 139), in some embodiments, an audible "click" sound and a tactile "click" may be detected by the user / patient. This can be beneficial for many reasons, including that the user / patient may only be able to hear the audible "click" sound when the reusable housing assembly 2972 and the disposable housing assembly 2974 (or in various embodiments, the dust cover or charger) are in the correct orientation and fully locked arrangement. This can assure the user / patient that the infusion pump assembly is in the correct fully locked position. Thus, in various embodiments where an audible "click" can be heard when the disposable housing assembly 2974 and the reusable housing assembly 2972 are attached, the infusion pump assembly includes two safety checks that they are fully locked, namely 1) the sensing components described and discussed above, and 2) the audible "click" mechanical components. In various embodiments, the disposable housing assembly 2974 may include a ramp feature on which the tab 2980 assembly rides as the reusable housing assembly 2972 is rotated from the unlocked position to the locked position relative to the disposable housing assembly 2974. At the ramp end, in some embodiments, a recess or undulation in the disposable housing assembly 2974 allows the tab 2980, actuated by the spring 2982, to "snap" into the recess / undulation. Other embodiments that enable audible and / or tactile indicators to the user / patient may be used in various embodiments.

[0195] The reusable housing assembly 802 may be attached to a number of different components, including, but not limited to, the disposable housing assembly, the dust cover, or the battery charger / battery charging station. In each case, the Hall effect sensor may detect that the locking ring is in the closed position and, thus, that the reusable housing assembly 802 is removably engaged with the disposable housing assembly, the dust cover, or the battery charger / battery charging station (or another component). The infusion pump system may determine the component to which it is attached by using an AVS system (which may also be referred to as a volume measurement sensor) described in more detail below, or by electrical contacts. Referring also to FIGS. 38B - 38D, an embodiment of a dust cover (e.g., dust cover 839) is shown. In the exemplary embodiment, the dust cover 839 may include features 841, 843, 845, 847 such that the locking ring of the reusable housing assembly 802 may be removably engaged with the dust cover 839. Additionally, the dust cover 839 may further include a recessed region 849 for accommodating the valve and pump features of the reusable housing assembly 804. Referring also to FIGS. 140A - 140D, in some embodiments, various embodiments of the dust covers 839, 2988 may include a sealed assembly 2990 that may be overmolded to provide a complete seal of the dust covers 839, 2988 to the reusable housing assembly 2972. As shown in FIG. 140D, which is a cross-sectional view of cross-section D of FIG. 140C, the sealed assembly 2990 is overmolded. Additionally, in some embodiments of the dust cover 2988, as may be shown in FIGS. 140A and 140B, the dust cover 2988 may include icons 2976, 2978.As described above, the icons 2976, 2978 may be molded, etched, and / or printed on the dust cover 2988 and may indicate "locking" and "unlocking" or similar indicators to assist the user / patient in understanding the orientation / position between the reusable housing assembly 2972 and the dust cover 2988, and / or may be in any form indicating whether the reusable housing assembly 2972 is in a locked or unlocked position relative to the dust cover 2988. For example, with respect to the dust cover, the AVS system may determine that the dust cover, rather than a disposable housing assembly, is connected to the reusable housing assembly. The AVS system may distinguish between using a reference table or other comparison data and comparing the measurement data with data of a characteristic dust cover or an empty disposable housing assembly. With respect to the battery charger, the battery charger may include electrical contacts in an exemplary embodiment. When the reusable housing assembly is attached to the battery charger, the infusion pump assembly electronic system may sense that contact has occurred and thus indicate that the reusable housing assembly is attached to the battery charger.

[0196] Referring also to FIGS. 43A - 45B and FIGS. 44A - 44C, an embodiment of a valve assembly 814 is shown that may include one or more valves and one or more pumps. Similar to injection pump assemblies 100, 100', 400, and 500, valve assembly 814 may generally include a reservoir valve 850, a plunger pump 852, a volume sensor valve 854, and a measurement valve 856. Similar to the previous description, reservoir valve 850 and plunger pump 852 may be actuated by a shape memory actuator 858 that may be tethered (at a first end) to a shape memory actuator anchor 860. Additionally, measurement valve 856 may be actuated via a valve actuator 862 by a shape memory actuator 864 that may be tethered (at a first end) to a shape memory actuator anchor 866. Similar to as described above, the measurement valve may be maintained in an open position via a measurement valve latch assembly 868. Measurement valve 856 may be released via activation of a shape memory actuator 870 that may be tethered (at a first end) by a shape memory actuator anchor 872. In some embodiments, shape memory actuator anchor 860 may be placed in a reusable housing assembly. By using this process during manufacture, it is ensured that the shape memory length actuator 858 is installed and maintains a desired length and tension / strain.

[0197] Referring also to FIGS. 45A - 45B and FIGS. 46A - 46E, a shape memory actuator 858 (which may include, for example, one or more shape memory wires) may actuate plunger pump 852 via an actuator assembly 874. Actuator assembly 874 may include a biasing spring 876 and a lever assembly 878. Actuator assembly 874 may actuate both plunger pump 852 and measurement valve 850.

[0198] Referring also to FIGS. 47A - 47B, the measurement valve 856 may be actuated by a shape memory actuator 864 via a valve actuator 862 and a lever assembly 878. When actuated, the measurement valve latch assembly 868 may maintain the measurement valve 856 in the open position. The measurement valve latch assembly 868 is actuated by a shape memory actuator 870 to release the measurement valve 856, allowing it to return to the closed position.

[0199] The disposable housing assembly 804 may be configured for single - use or for use over a specified period, such as, for example, three days or any other amount of time. The disposable housing assembly 804 may be configured such that any component within the infusion pump assembly 800 that contacts the injectable fluid may be disposed on top of and / or inside the disposable housing assembly 804. Thus, the risk of contaminating the injectable fluid can be reduced.

[0200] Referring also to FIGS. 48 and 49A - 49C, the disposable housing assembly 804 may include a base portion 900, a membrane assembly 902, and an upper portion 904. The base portion 900 may include a recess 906 that, together with the membrane assembly 902, defines a reservoir 908 for receiving an injectable fluid (not shown), such as insulin. Referring also to FIGS. 50A - 50C, the recess 906 may be at least partially formed by and integral with the base portion 900. The membrane assembly 902 may be in sealing engagement with the base portion 900, for example, by being compression - clamped between the base portion 900 and the upper portion 904. The upper portion 904 may be attached to the base portion 900 by conventional means such as adhesion, heat - fusion, ultrasonic welding, and compression fitting. Additionally / alternatively, the membrane assembly 902 may be attached to the base portion 900 via, for example, adhesion, ultrasonic welding, heat - fusion, and equivalents, to provide a seal between the membrane assembly 902 and the base portion 900.

[0201] Referring also to FIGS. 141A - 141B, an embodiment of a disposable housing assembly 2974 without an upper portion or membrane assembly is shown. Referring to FIG. 141B, an enlarged cutaway view of pump chamber 106B as indicated by "B" in FIG. 141A is shown. In some embodiments, a groove 2992 is included on the wall of the pump chamber. In some embodiments, the groove allows fluid to flow while the pump plunger 106A is fully actuated, and thus may prevent the pump plunger 106A from sealing off the outflow from pump chamber 106B. FIGS. 142B and 142C are cross-sectional views of FIG. 142A taken at cross-sections "B" and "C", respectively. Groove 2992 can be seen within pump chamber 106B.

[0202] Referring also to FIGS. 143A - 143B, in some embodiments of the disposable housing assembly 2974, the disposable housing assembly 2974 may include at least one outlet 2994, which in some embodiments may include a filter 2996, which in some embodiments may be a hydrophobic filter, which in some embodiments may be a 10 micron filter made from a POREX PM 1020 MUPOR microporous PTFE membrane, although in other embodiments, different sizes or types of filters, such as 5 micron, 15 micron filters, and / or GORTEX filters may be used.

[0203] Still referring to FIGS. 48 and 50A, in the exemplary embodiment, the recess 906 includes a raised portion 901 that includes an area 903 around a fluid opening 905 that leads to a fluid line. The raised portion 901 extends around the recess 906 in the exemplary embodiment. However, in other embodiments, the raised portion 901 may not extend around the entire perimeter, but may be partially around the perimeter. The area 903 around the fluid opening 905 may include an angled portion that includes an angle of 45 degrees and may be shaped as shown in the exemplary embodiment, but in other embodiments the angle may be larger or smaller. In some embodiments, the pump may not generate enough vacuum to crush the reservoir so as to expel the entire volume of fluid that may be stored in the reservoir. The raised portion 901 may act to minimize wasted fluid.

[0204] In the exemplary embodiment, the fluid opening 905 may include three openings, but in other embodiments may include more or fewer openings and may be surrounded by the area 903 of the raised portion. In the exemplary embodiment, the fluid opening 905 may have a narrow center and thus generate surface tension that can prevent air from being drawn into the opening. In the exemplary embodiment, this area may be designed to encourage air present in the reservoir to be drawn above one of the fluid openings 905 rather than through the fluid opening 905 into the fluid line. Additionally, since there may be more than one fluid opening 905, if a bubble is trapped above one opening, the air may not prevent fluid from flowing through the other two openings.

[0205] Referring also to FIGS. 144A - 144E, another embodiment of the disposable housing assembly 2974 is shown. In these embodiments, as shown in FIG. 144B, which shows an enlarged cross - sectional view of cross - section “B” as shown in FIG. 144A, and as shown in FIG. 144D, which shows an enlarged cross - sectional view of cross - section “D” as shown in FIG. 144C, FIG. 144E is an explanatory diagram of a bubble trap, in which the bubble trap 2998 and the raised region 3000 and the radius 3006 and the undulation 3016 with respect to the partition are included in the reservoir 3002. In this embodiment, the bubble trap 2998 is located around the wall of the reservoir 3002 and the radius 3006. However, in the region of the raised region 3000, the bubble trap 2998 includes an outlet section. In the non - outlet sections around the reservoir 3002, the bubble trap 2998 includes essentially two parts, such as a tapered part 3008 that tapers to a bottom part 3010. In the outlet section, the tapered part 3008 is shown as terminating at the end of the tapered part 3014, and the bottom part 3010 continues to the reservoir outlet 3004 in the upwardly sloping part 3012. The reservoir 3002 includes a membrane (not shown) that essentially forms a “tunnel” between the membrane and the fluid outlet, together with the raised region 3000 and the upwardly sloping part 3012.

[0206] As the fluid in the reservoir is sent out from the reservoir, the membrane (not shown) moves towards the reservoir wall 3002. In the embodiments shown in FIGS. 144A - 144D, the fluid tends to collect at the bottom part 3010 of the bubble trap 2998, while the air bubbles do not. Rather, to the extent that air is present, the air bubbles tend to collect in the tapered part 3008 of the bubble trap 2998. In the raised region 3000 where the tapered part 3008 of the bubble trap 2998 terminates at the end of the tapered part 3014, the air bubbles are less likely to enter into the upwardly sloping part 3012 to the extent that they exist, and thus are less likely to be sent out through the outlet of the reservoir 3004.

[0207] Therefore, as the fluid is delivered through the outlet of reservoir 3004, air is not drawn out through the outlet of reservoir 3004. The embodiments shown in FIGS. 144A - 144D include, but are not limited to, reducing the air delivered from reservoir 3002 into the fluid path in disposable housing assembly 2974, which can be beneficial for many reasons. Since bubbles have a greater surface tension than the fluid, the bubbles no longer tend to collect at the bottom portion 3010 of bubble trap 2998 and instead flow up over the end of tapered portion 3014 onto upwardly sloped portion 3012 and no longer tend to flow through the outlet of reservoir 3004.

[0208] Referring also to FIGS. 51A - 51C, the disposable housing assembly 804 may also include a fluid path cover 910. The fluid path cover 910 may be received within a cavity 912 formed above / inside the base portion 900. The fluid path cover 910 may, in some embodiments, include at least a portion of one or more channels (e.g., channel 914). The channels included in the fluid path cover 910 may fluidly connect one or more volcano valve features (e.g., volcano valve 916) included above the base portion 900. The volcano valve 916 may include a protrusion having an opening extending therethrough. Additionally, the fluid path cover 910 and the base portion 900 may each define a portion of a recess (e.g., recessed portions 918, 920 included in the base portion 900 and the fluid path cover 910, respectively) for fluidly connecting to an infusion set (e.g., including cannula 922). The cannula 922 may be connected to the disposable housing assembly 804 by conventional means (e.g., adhesion, heat fusion, compression fitting, or the like). The fluid path defined by the volcano valves (e.g., volcano valve 916) of the fluid path cover 910 and the base portion 900 may define a fluid path between the reservoir 908 and the cannula 922 for delivery of injectable fluid to the user via the infusion set. However, in some embodiments, the fluid path cover 910 may include at least a portion of the fluid path, and in some embodiments, the fluid path cover 910 may not include at least a portion of the fluid path. In an exemplary embodiment, the fluid path cover 910 may be laser welded to the base portion 900. However, in other embodiments, the fluid path cover 910 may also be connected to the base portion 900 by conventional means (e.g., adhesion, heat fusion, ultrasonic welding, compression fitting, or the like) to achieve a substantially fluid - tight seal between the fluid path cover 910 and the base portion 900.

[0209] Referring also to FIGS. 54A - 54C, the disposable housing assembly 804 may further include a valve membrane cover 924. The valve membrane cover 924 may be disposed at least partially over and cover a volcano valve (e.g., volcano valve 916) and a pump recess 926 included in the upper / inner side of the base portion 900. The valve membrane cover 924 may include a flexible material that can be selectively engaged, for example, with the volcano valve by the reservoir valve 850, the volume sensor valve 854, and the measurement valve 856 of the reusable housing assembly 802 to control the flow rate of an injectable fluid. Additionally, the valve membrane cover 924 may be elastically deformed into the pump recess 926 by the plunger pump 852 to achieve delivery of the injectable fluid. The valve membrane cover 924 may be engaged between the base portion 900 and the upper portion 904 of the disposable housing assembly 804 to form a seal 928 between the valve membrane cover 924 and the base portion 900. For example, in an exemplary embodiment, the valve membrane cover 924 may be overmolded onto the base portion 900. In other embodiments, the valve membrane cover 924 may be compression clamped between the base portion 900 and the upper portion 904 to form the seal 928. Additionally / alternatively, the valve insert may be connected to one or more of the base portion 900 and the upper portion 904 by, for example, adhesion, heat fusion, or the like.

[0210] Referring also to FIGS. 53A - C, the upper portion 904 may include alignment tabs 930, 932 configured to be at least partially received within openings 836, 838 of the substrate 818 of the reusable housing assembly 802 so as to ensure proper alignment between the reusable housing assembly 802 and the disposable housing assembly 804. Additionally, the upper 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 the locking ring assembly 806. One or more of the radial tabs (e.g., radial tab 940) may include a stop (e.g., alignment tab stop 950, which may be used for welding, a tab that fits into a recess for positioning and ultrasonic welding) that may prevent further rotation of the locking ring assembly 806 when, for example, the reusable housing assembly 802 and the disposable housing assembly 804 are fully engaged.

[0211] As described above, the valve membrane insert 924 may enable the delivery and flow of injectable fluid by the reservoir valve 850, the plunger pump 852, the volume sensor valve 854, and the measurement valve 856. Accordingly, the upper portion 904 may include one or more openings (e.g., openings 952, 954, 956) that may expose at least a portion of the valve membrane insert 924 for actuation by the reservoir valve 850, the plunger pump 852, the volume sensor valve 854, and the measurement valve 856. Additionally, the upper portion 904 may include one or more openings 958, 960, 962 configured to enable control of the fill volume during filling of the reservoir 908, as discussed in more detail below. The reservoir assembly 902 may include ribs 964, 966, 968 (e.g., as shown in FIG. 52A) that may be at least partially received within each of the openings 958, 960, 962. As discussed in more detail below, a force may be applied to one or more of the ribs 964, 966, 968 to at least temporarily reduce the volume of the reservoir 908.

[0212] In some embodiments, it may be desirable to provide a seal between the reusable housing assembly 802 and the disposable housing assembly 804. Thus, the disposable housing assembly 804 may include a sealing assembly 970. The sealing assembly 970 may include, for example, an elastomeric member that, when engaged, may provide a compressible rubber or plastic layer between the reusable housing assembly 802 and the disposable housing assembly 804, and thus may prevent inadvertent disengagement and penetration by external fluids. For example, the sealing assembly 970 may be a watertight assembly and thus may enable a user to wear the infusion pump assembly 800 during swimming, bathing, or exercise.

[0213] For example, similar to the disposable housing assembly 114, in some embodiments, the disposable housing assembly 802 may be configured to fill the reservoir 908 multiple times. However, in some embodiments, the disposable housing assembly 114 may be configured such that the reservoir 908 may not need to be refilled. Referring also to FIGS. 57 - 64, the filling adapter 1000 may be configured to be coupled to the disposable housing assembly 804 for refilling the reservoir 908 using a syringe (not shown). The filling adapter 1000 may include locking tabs 1002, 1004, 1006, 1008 that may be configured to engage the radial tabs 934, 936, 938, 940 of the disposable housing assembly 804, similar to the tabs 942, 944, 946, 948 of the locking ring assembly 806. Thus, the filling adapter 1000 may be removably engaged with the disposable housing assembly 804 by aligning the filling adapter 1000 with the disposable housing assembly 804 and rotating the filling adapter 1000 and the disposable housing assembly 804 relative to each other to removably engage the locking tabs 1002, 1004, 1006, 1008 with the radial tabs 934, 936, 938, 940.

[0214] The filling adapter 1000 may further include a filling aid 1010 which may be, for example, a guide passage 1012 configured to direct a needle of a syringe (not shown) to a partition wall of the disposable housing assembly 804, enabling the reservoir 908 of the disposable housing assembly 804 to be filled by the syringe. In some embodiments, the guide passage 1012 may be an angled ramp or other stepped angled ramp to further direct the syringe to the partition wall. The filling adapter 1000 may facilitate filling the reservoir 908, for example, by providing a relatively large insertion area at the distal opening of the guide passage 1012. The guide passage 1012 may generally taper to a smaller proximal opening which may be properly aligned with the partition wall of the disposable housing assembly 804 when the filling adapter 1000 is engaged with the disposable housing assembly 804. Thus, the filling adapter 1000 may reduce the skill and aiming required to properly insert the needle through the partition wall of the disposable housing assembly 804 for the purpose of filling the reservoir 908.

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

[0216] The filling adapter 1000 may include one or more button assemblies (e.g., button assemblies 1014, 1016, 1018) corresponding to ribs 964, 966, 968. That is, when the filling adapter 1000 is removably engaged with the disposable housing assembly 804, the buttons 1014, 1016, 1018 may be aligned with the ribs 964, 966, 968. The button assemblies 1014, 1016, 1018 may be, for example, cantilever members that can be depressed. When the filling adapter 1000 is removably engaged with the disposable housing assembly 804, one or more of the button assemblies 1014, 1016, 1018 may be depressed, and correspondingly, one of each of the ribs 964, 966, 698 may be displaced into the reservoir 908, causing an attendant reduction in the volume of the reservoir 908.

[0217] For example, for illustrative purposes, assume that the reservoir 908 has a maximum capacity of 3.00 mL. Further, assume that the button assembly 1014 is configured to displace the rib 964 into the disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Further, assume that the button assembly 1016 is configured to displace the rib 966 into the disposable housing assembly 804, similarly resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Further, assume that the button assembly 1018 is configured to displace the slot assembly 968 into the disposable housing assembly 804, similarly resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Thus, if a user desires to fill the reservoir 908 within the disposable housing assembly 804 with 2.00 mL of injectable fluid, in some embodiments, the user may first fill the reservoir to its 3.00 mL capacity and then depress the button assemblies 1016 and 1014 (which causes displacement of the rib 966 into the disposable housing assembly 804), effectively reducing the 3.00 mL capacity of the reservoir 908 within the disposable housing assembly 804 to 2.00 mL. In some embodiments, the user may first depress each respective number of button assemblies to effectively reduce the capacity of the reservoir 908 and then fill the reservoir 908. Although a specific number of button assemblies are shown to represent an exemplary embodiment, in other embodiments, the number of button assemblies may vary from a minimum of 1 to as many as desired. Additionally, for illustrative purposes, in the exemplary embodiment, each button assembly may displace 0.5 mL, but in other embodiments, the volume of displacement per button may vary. Additionally, the reservoir may include a larger or smaller volume than that described in the exemplary embodiment in various embodiments.

[0218] According to the foregoing configuration, at least partially, a button assembly (e.g., button assemblies 1014, 1016, 108) may be employed to control the filling volume of the reservoir 908. By not pressing any of the button assemblies, the maximum filling volume of the reservoir 908 may be achieved. Pressing one button assembly (e.g., button assembly 1014) may enable a second maximum filling volume to be achieved. By pressing two button assemblies (e.g., button assemblies 1014, 1016), a third maximum filling volume may be achieved. By pressing all three button assemblies (e.g., button assemblies 1014, 1016, 1018), the minimum filling volume may be enabled to be achieved.

[0219] Furthermore, in an embodiment, button assemblies 1014, 1016, 1018 may be utilized to at least partially facilitate filling of the reservoir 908. For example, when a filling needle (which may be fluidly connected to a vial of injectable fluid) is inserted into the reservoir 908, the button assemblies 1014, 1016, 1018 may be pressed to send at least a portion of the air that may be contained within the reservoir into the vial of injectable fluid. The button assemblies 1014, 1016, 1018 may later be released to allow the injectable fluid to flow from the vial into the reservoir 908. When the reservoir 908 is filled with injectable fluid, one or more button assemblies (one or more of button assemblies 1014, 1016, 1018) may be pressed, thereby pushing out at least a portion of the injectable fluid from the reservoir 908 (e.g., via a needle used to fill the reservoir 908 and return to the vial of injectable fluid). As described above, the volume of injectable fluid contained within the reservoir 908 may be controlled (e.g., by controlling how much injectable fluid is pushed back into the vial of injectable fluid) depending on, for example, how many button assemblies are pressed.

[0220] Referring particularly to FIGS. 62 - 64, the filling aid 1010 may be pivotally coupled to the filling adapter substrate 1020. For example, the filling aid 1010 may include pivot members 1022, 1024 configured to be received within pivot supports 1026, 1028, thereby enabling the 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 FIGS. 63 - 64). The closed position may be suitable, for example, for packaging the filling adapter 1000, storing the filling adapter 1000, or the like. To ensure that the filling aid 1010 is properly oriented for filling the reservoir 908, the filling adapter 1000 may include a support member 1030. To properly orient the filling aid 1010, the user may pivot the filling aid 1010 to the fully open position, and the filling aid 1010 may contact the support member 1030.

[0221] According to an alternative embodiment, also referring to FIG. 65, the filling adapter 1050 may be configured to removably engage with the disposable housing assembly 804 via a plurality of locking tabs (e.g., locking tabs 1052, 1054). Additionally, the filling adapter 1050 may include a plurality of button assemblies (e.g., button assemblies 1056, 1058, 1060) that interact with ribs 964, 966, 968 of the disposable housing assembly 804 to adjust the filling volume of the reservoir 908. The filling adapter 1050 may further include a filling aid 1062 having a guide passage 1064 configured to align a syringe needle with a septum of the disposable housing 804 for the purpose of accessing the reservoir 908, for example, to fill the reservoir 908 with an injectable fluid. The filling aid 1062 may be connected to the substrate 1066, for example, as an integral component thereof, by adhesion, heat fusion, compression fitting, or the like.

[0222] Referring also to FIGS. 66 - 74, the vial filling adapter 1100 may be configured to facilitate filling the reservoir 908 of the disposable housing assembly 804 directly from the vial. Similar to the filling adapter 1000, the vial filling adapter 1100 may include locking tabs 1102, 1104, 1106, 1108 configured to engage with the radial tabs 934, 936, 938, 940 of the disposable housing assembly, substantially similar to the tabs 942, 944, 946, 948 of the locking ring assembly 806. Thus, the vial filling adapter 1100 may be removably engaged with the disposable housing assembly 804 by aligning the vial filling adapter 1100 with the disposable housing assembly 804 and rotating the filling adapter 1100 and the disposable housing assembly 804 relative to each other to removably engage the locking tabs 1102, 1104, 1106, 1108 with the radial tabs 934, 936, 938, 940.

[0223] As described above, the disposable housing assembly 804 may be configured to facilitate controlling the amount of injectable fluid delivered to the reservoir 908 during filling. For example, the membrane assembly 902 of the disposable housing assembly 804 may include ribs 964, 966, 968 that can be depressed and displaced at least partially into the reservoir 908, thereby reducing the volume of the reservoir 908. Thus, when injectable fluid is delivered to the reservoir 908, the volume of fluid that may be contained by the reservoir 908 may be correspondingly reduced. The ribs 964, 966, 968 may be accessible through the openings 958, 960, 962 in the upper portion 904 of the disposable housing assembly 804.

[0224] The vial filling adapter 1100 may include one or more button assemblies (e.g., button assemblies 1110, 1112, 1114) corresponding to ribs 964, 966, 968 (as shown in FIG. 52A). That is, when the vial filling adapter 1100 is removably engaged with the disposable housing assembly 804, the buttons 1110, 1112, 1114 may be aligned with the ribs 964, 966, 968. The button assemblies 1110, 1112, 1114 may be, for example, cantilever members that can be depressed. When the vial filling adapter 1100 is removably engaged with the disposable housing assembly 804, one or more of the button assemblies 1110, 1112, 1114 may be depressed, and correspondingly, one of each of the ribs 964, 966, 698 may be displaced into the reservoir 908, thereby reducing the volume of the reservoir 908.

[0225] For example, for illustrative purposes, assume that the reservoir 908 has a maximum capacity of 3.00 mL. Further, assume that the button assembly 1110 is configured to displace the rib 964 into the disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Further, assume that the button assembly 1112 is configured to displace the rib 966 into the disposable housing assembly 804, similarly resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Further, assume that the button assembly 1114 is configured to displace the rib 968 into the disposable housing assembly 804, similarly resulting in a 0.5 mL reduction in the 3.00 mL capacity of the disposable housing assembly 804. Thus, if a user desires to fill the reservoir 908 within the disposable housing assembly 804 with 2.00 mL of injectable fluid, the button assemblies 1112 and 1114 can be depressed (resulting in the displacement of the ribs 966 and 968 into the disposable housing assembly 804), effectively reducing the 3.00 mL capacity of the reservoir 908 within the disposable housing assembly 804 to 2.00 mL.

[0226] The vial filling adapter 1100 may further include a vial filling assist assembly 1116 configured to fluidly couple, via a septum, a disposable housing assembly 804's reservoir 908 with an injectable fluid vial. Referring particularly to FIG. 71, the vial filling assist assembly may include a double-ended needle assembly 1118. The double-ended needle assembly 1118 may include a first needle tip 1120 configured to penetrate a septum of a vial (not shown) and a second needle tip 1122 configured to penetrate a septum of the disposable housing assembly 804. Accordingly, the vial and the reservoir 908 may be fluidly coupled, enabling transfer of the injectable fluid from the vial to the reservoir 908. The double-ended needle assembly 1118 may include a vial engagement portion 1124 adjacent the first end 1120. The vial engagement arms 1124, 1126 may be configured, for example, to removably engage a vial cap to assist in maintaining a fluid connection between the double-ended needle assembly 1118 and the vial. Additionally, the double-ended needle assembly 1118 may include a body 1128 that may be slidably received within an opening 1130 of a vial filling assist body 1132. The vial filling assist body 1132 may include stabilizer arms 1134, 1136 configured, for example, to stabilize the vial during filling of the disposable housing assembly 804. In one embodiment, the vial may be engaged with the double-ended needle assembly 1118 such that, for example, the first end 1120 may penetrate the septum of the vial, and the vial cap may be engaged by the engagement arms 1124, 1126. The body 1128 may be slidably inserted into the opening 1130 such that the second end 1122 of the double-ended needle assembly 1118 may penetrate the septum of the disposable body assembly 804.

[0227] Similar to the filling adapter 1000, the vial filling assist assembly 1116 may be configured to be pivotally coupled to the vial filling adapter substrate 1138. For example, the vial filling assist 1116 may include pivot members 1140, 1142 configured to be received within pivot supports 1144, 1146 (shown, for example, in FIG. 71), thereby enabling the vial filling assist 1116 to pivot between an open position (such as shown in FIGS. 66 - 70) and a closed position (such as shown in FIGS. 72 - 74). The closed position may be suitable, for example, for packaging of the vial filling adapter 1100, storage of the vial filling adapter 1100, or the like. The vial filling adapter 1100 may include a support member 1148 to ensure that the vial filling assist 1116 is properly oriented for filling the reservoir 908. To properly orient the vial filling assist 1116, the user may pivot the vial filling assist 1116 to the fully open position, and the vial filling assist 1116 may contact the support member 1148. Additionally, the vial filling adapter substrate 1138 may include one or more locking features (such as locking tabs 1150, 1152) that may engage the vial filling assist 1116 and hold the vial filling assist 1116 in the closed position. The vial filling adapter substrate 1138 may also include features (such as tabs 1154, 1156) configured to assist in holding the double-ended needle assembly 1118, for example, by preventing proper separation of the double-ended needle assembly 1118 from the vial filling assist body 1132.

[0228] As shown in FIGS. 72 - 74, the filling assist assembly 1116 is in the closed position. In this configuration, the support member 1148 may additionally function as a needle guard. When removing the filling assist assembly 1116 from the disposable housing assembly 804, the support member 1148 may function to safely enable the user to firmly grip the end and rotate the filling assist assembly 1116 for removal. As shown in FIG. 70, in the open position, the support member 1148 may function as a stop to maintain proper orientation.

[0229] Referring again to FIGS. 57 - 73, an exemplary embodiment of the filling adapter includes a gripping feature (e.g., 1166 in FIG. 72). The gripping feature 1166 may provide a gripping interface for removing the filling adapter from the disposable housing assembly 804. As shown in one configuration of these figures, in other embodiments, the configuration may vary. In still other embodiments, the gripping feature may not be included.

[0230] According to one embodiment, the filling adapter substrate 1020 and the vial filling adapter substrate 1138 may be replaceable components. Thus, a single substrate (e.g., either the filling adapter substrate 1020 or the vial filling adapter substrate 1138) may be used with either the filling aid 1010 or the vial filling aid 1116. Thus, the number of individual components required for both filling adapters may be reduced, and the user may have the ability to select the filling adapter that may be most suitable for a given filling scenario.

[0231] Various embodiments of the filling adapter may provide a system for filling a reservoir without handling needles, protect the reservoir from unintentional contact with a needle, i.e., destruction of the integrity of the reservoir through an unintentional puncture, be designed to be ambidextrous, and may provide many safety advantages including, but not limited to, providing a system for maintaining air in the reservoir in some embodiments.

[0232] As described above, the reusable housing assembly 802 may include a battery 832, which may include, for example, a rechargeable battery. Referring also to FIGS. 75-80, the battery charger 1200 may be configured to recharge the battery 832. The battery charger 1200 may include a housing 1202 having a top plate 1204. The top plate 1204 may include one or more electrical contacts 1206 that are generally configured to be electrically coupled to the electrical contacts 834 of the reusable housing assembly 802. The electrical contacts 1206 may include, but are not limited to, electrical contact pads, spring-biased electrical contact members, or the like. Additionally, the top plate 1204 may include alignment tabs 1208, 1210 that may be configured to engage the openings 836, 838 of the substrate 818 of the reusable housing assembly 802 (such as shown in FIG. 35C). The cooperation of the alignment tabs 1208, 1210 and the openings 836, 838 may ensure that the reusable housing assembly 802 is aligned with the battery charger 1200 such that the electrical contacts 1206 of the battery charger 1200 can be electrically coupled to the electrical contacts 834 of the reusable housing assembly 802.

[0233] Referring also to FIGS. 77 and 78, the battery charger 1200 may be configured to removably engage the reusable housing assembly 802. For example, similar to the disposable housing assembly 804, the battery charger 1200 may include one or more locking tabs (such as the locking tabs 1212, 1214 shown in FIG. 76). The locking tabs (such as locking tabs 1212, 1214) may be engaged by the tabs 942, 944, 946, 948 of the locking ring assembly 806. Thus, the reusable housing assembly 802 may be aligned with the battery charger 1200 (via the alignment tabs 1208, 1210) with the locking ring 806 in a first unlocked position, as shown in FIG. 77. The locking ring 806 may be rotated relative to the battery charger 1200 in the direction of arrow 1216 such that the tabs 942, 944, 946, 948 of the locking ring 806 are removably engaged with the locking tabs (such as locking tabs 1212, 1214) of the battery charger 1200, as shown in FIG. 78.

[0234] In an embodiment, the battery charger 1200 may include a recessed region 1218 that provides a gap and may house the pump and valve components of the reusable housing assembly 802. Referring also to FIGS. 79 and 80, the battery charger 1200 may provide a current to the electrical contacts 1206 (and thereby to the reusable housing assembly 802 via the electrical contacts 834) to recharge the battery 832 of the reusable housing assembly 802. In some embodiments, the current may not be provided to the electrical contacts 1206 when a signal indicating a fully engaged reusable housing is not provided. According to such embodiments, risks associated with short circuits (e.g., due to foreign objects contacting the electrical contacts 1206) and damage to the reusable housing assembly 802 (e.g., due to improper initial alignment between the electrical contacts 1206 and the electrical contacts 834) may be reduced. In addition, when the battery charger is not charging the reusable housing assembly 802, the battery charger 1200 may not draw current unnecessarily.

[0235] Still referring to FIGS. 79 and 80, the battery charger 1200 may include a lower housing portion 1224 and a top plate 1204. A printed circuit board 1222 (which may include, for example, the electrical contacts 1206) may be disposed within a cavity included between the top plate 1204 and the lower housing portion 1224.

[0236] Referring also to FIGS. 81 - 89, various embodiments of a battery charger / docking station are shown. FIGS. 81 and 82 depict a desktop charger 1250 that includes a recess 1252 configured to engage and recharge a reusable housing assembly (e.g., reusable housing assembly 802). The reusable housing assembly may rest within the recess 1252 and / or may be removably engaged within the recess 1252 in a manner similar to that discussed previously. Additionally, the desktop charger 1250 may include a recess 1254 configured to engage a remote control assembly (e.g., remote control assembly 300). The recess 1254 may include, for example, a USB plug 1256 that may be configured to couple to the remote control assembly when the remote control assembly is disposed within the recess 1254. The USB plug 1256 may enable data transfer to / from the remote control assembly and charging of the remote control assembly. The desktop charger 1250 may also include a USB port 1258 (which may include, for example, a mini - USB port) that enables the desktop charger to receive power (e.g., for charging the reusable housing assembly and / or the remote control assembly). Additionally / alternatively, the USB port 1258 may be configured for data transfer to / from the remote control assembly and / or the reusable housing assembly, for example, by connection to a computer (not shown).

[0237] Referring to FIGS. 83A - 83B, similar to previous embodiments, the desktop charger 1260 may include a recess 1262 for engaging a reusable housing assembly (e.g., reusable housing assembly 1264). The desktop charger may also include a recess 1266 configured to receive a remote control assembly (e.g., remote control assembly 1268). One or more of the recesses 1262, 1266 may each include electrical and / or data connections configured to charge and / or transfer data to / from the reusable housing assembly 1262 and / or the remote control assembly 1268.

[0238] Referring to FIGS. 84A-84B, another embodiment of a desktop charger is shown. Similar to the desktop charger 1260, the desktop charger 1270 may each include a recess (not shown) for engaging a reusable housing assembly 1272 and a remote control assembly 1274. As shown, the desktop charger 1270 may carry the reusable housing assembly 1272 and the remote control assembly 1274 in a parallel configuration. The desktop charger 1270 may include various electrical and data connections configured to charge and / or transfer data to / from the reusable housing assembly 1272 and / or the remote control assembly 1274, as described in the various embodiments above.

[0239] Referring to FIGS. 85A-85D, the crushable charger 1280 may include a recess 1282 for receiving a reusable housing assembly 1284 and a remote control assembly 1286. The crushable charger 1280 may include various electrical and data connections configured to charge and / or transfer data to / from the reusable housing assembly 1284 and / or the remote control assembly 1286, as described in the various embodiments above. Additionally, as shown in FIGS. 85B-85D, the crushable charger 1280 may include a pivotable cover 1288. The pivotable cover 1288 may be configured to pivot between an open position (e.g., as shown in FIG. 85B) where the reusable housing assembly 1284 and the remote control assembly 1286 can be docked to the crushable charger 1280, and a closed position (e.g., as shown in FIG. 85D) where the recess 1282 may be covered by the pivotable cover 1288. In the closed position, the recess 1282, as well as any electrical and / or data connections disposed therein, may be protected from damage.

[0240] Referring to FIG. 86, the wall charger 1290 may include a recess 1292 configured to receive the reusable housing assembly 1294. Additionally, the wall charger 1290 may include a recess 1296 configured to receive the remote control assembly 1298. The reusable housing assembly 1294 and the remote control assembly 1298 may be positioned in a stacked configuration, for example, thereby providing a relatively thin profile. The rear portion of the wall charger 1290 may include an electrical plug configured to enable the wall charger to be plugged into an electrical outlet. Thus, the wall charger 1290 may achieve a wall-mounted configuration while plugged into an electrical outlet. Additionally, while plugged into an electrical outlet, power may be provided to the wall charger 1290 to charge the reusable housing assembly 1294 and / or the remote control assembly 1298.

[0241] Referring to FIG. 87, the wall charger 1300 may include a recess 1302 configured to receive the remote control assembly 1304. Additionally, the wall charger may include a recess (not shown) configured to receive the reusable housing assembly 1306. The wall charger 1300 may be configured to position the remote control assembly 1304 and the reusable housing assembly 1306 in an antiparallel configuration that may provide a relatively thin profile. Additionally, the wall charger 1300 may include an electrical plug 1308 configured to be plugged into an electrical outlet. The electrical plug 1308 may include a retractable configuration in which the electrical plug 1308 may be pivotable between a deployed position (e.g., as shown) and a retracted position. In the deployed position, the electrical plug 1308 may be oriented to be plugged into an electrical outlet. In the retracted position, the electrical plug 1308 may be disposed within a recess 1310 that may protect the electrical plug 1308 from damage and / or from damaging other items.

[0242] Referring to FIG. 88, the charger 1320 may include a recess 1322 configured to receive a reusable housing assembly 1324. The charger 1320 may additionally include a recess (not shown) configured to receive a remote control assembly 1326. The charger 1320 may additionally include a cover 1328. The cover 1328 may be configured to pivot between an open position (not shown) and a closed position. When the cover 1328 is in the open position, the reusable housing assembly 1324 and the remote control assembly 1326 may be accessible (e.g., enabling a user to remove / install the reusable housing assembly 1324 and / or the remote control assembly 1326 from / into the charger 1320). When the cover 1324 is in the closed position, the cover 1328 and the charger body 1330 may substantially enclose the reusable housing assembly 1324 and / or the remote control assembly 1326 and / or the recess 1322, the recess being configured to receive the remote control assembly 1326, thereby providing protection against damage and / or tampering to the reusable housing assembly 1324, the remote control assembly 1326, and / or any electrical and / or data connections associated with the charger 1320.

[0243] Referring to FIGS. 89A - 89B, the wall charger 1350 may include a recess 1352 configured to receive a remote control assembly 1354. The wall charger 1350 may also include a recess 1356 configured to receive a reusable housing assembly 1358. The wall charger 1350 may be configured to position the remote control assembly 1354 and the reusable housing assembly 1358 in a substantially parallel configuration, thereby providing a relatively thin profile. The charger 1350 may additionally include an electrical plug 1360 configured, for example, to be inserted into an electrical outlet. The electrical plug 1360 may include a retractable configuration such that the electrical plug 1360 may be pivotable between a deployed position (e.g., as illustrated) and a retracted position. In the deployed position, the electrical plug 1360 may be oriented to be inserted into an electrical outlet. In the retracted position, the electrical plug 1360 may be disposed within a recess 1362 that may protect the electrical plug 1308 from damage and / or from damaging other items.

[0244] Infusion pump therapy may include volume and time specifications. The amount of fluid dispensed along with the dispensing timing can be two important factors in infusion pump therapy. As discussed in detail below, the infusion pump devices and systems described herein may provide a method of dispensing fluid, along with devices, systems, and methods for measuring the amount of fluid dispensed. However, in situations where calibration and accuracy of the measurement device are important, there may be an advantage in determining a degradation of the measurement device's accuracy as soon as possible. Thus, there are advantages in off - board verification of volume and delivery.

[0245] As described above, the infusion pump assembly 100 may include a volume sensor assembly 148 configured to monitor the amount of fluid infused by the infusion pump assembly 100. Further, as described above, the infusion pump assembly 100 may be configured such that the volume measurements generated by the volume sensor assembly 148 may be used through a feedback loop to control the amount of injectable fluid injected into the user.

[0246] Referring also to FIGS. 90A-90C, one diagram and two cross-sectional views of the volume sensor assembly 148 are shown. Referring also to FIGS. 91A-91I, various isometric views and diagrams of the volume sensor assembly 148 (which is shown to include the upper housing 1400) are shown. Referring also to FIGS. 92A-92I, various isometric views and diagrams of the volume sensor assembly 148 (with the upper housing 1400 removed) exposing the speaker assembly 622, the reference microphone 626, and the printed circuit board assembly 830 are shown. Referring also to FIGS. 93A-93I, various isometric views and diagrams of the volume sensor assembly 148 (with the printed circuit board assembly 830 removed) exposing the port assembly 624 are shown. Referring also to FIGS. 94A-94F, various isometric views and cross-sectional diagrams of the volume sensor assembly 148 (with the printed circuit board assembly 830 removed) exposing the port assembly 624 are shown. Referring also to FIG. 95, an exploded view of the volume sensor assembly 148 exposing the upper housing 1400, the speaker assembly 622, the reference microphone 626, the seal assembly 1404, the lower housing 1402, the port assembly 624, the spring diaphragm 628, and the retaining ring assembly 1406 is shown.

[0247] The following discussion relates to the design and operation of the volume sensor assembly 148 (shown in simplified form in FIG. 96). For the following discussion, the following names may be used.

[0248]

Table 5

[0249] Derivation of equations for the volume sensor assembly 148: Modeling of acoustic volume The pressure and volume of an ideal adiabatic gas can be related as follows.

[0250]

Chemical formula

[0251] In the formula, K is a constant defined by the initial conditions of the system.

[0252] Equation 1 can be described as follows in terms of the average pressure P, the volume V, and, in addition to these pressures, small time-dependent disturbances p(t) and v(t).

[0253]

Chemical formula

[0254] By differentiating this equation, the following equation can be obtained.

[0255]

Chemical formula

[0256] This can be simplified to the following equation.

[0257]

Chemical formula

[0258] When the sound pressure level is much less than the atmospheric pressure, the equation can be further simplified to the following equation.

[0259]

Chemical formula

[0260] Regarding the validity of this assumption, the following can be shown using the adiabatic relation.

[0261]

Chemical formula

[0262] Therefore, the error of the assumption is as follows.

[0263]

Chem.

[0264] A very large acoustic signal (120 dB) can correspond to a pressure sine wave with an amplitude of about 20 Pascals. Assuming air under atmospheric conditions (γ = 1.4, P = 101325 Pa), the resulting error is 0.03%. The conversion from dB to Pa is as follows.

[0265]

Chem.

[0266] where P ref = 20·μPa.

[0267] Applying the ideal gas law P = ρRT and substituting into the pressure can result in the following equation.

[0268]

Chem.

[0269] Equation 9 can be described as follows for the speed of sound

[0270]

Chem.

[0271] can be described with respect to.

[0272]

Chem.

[0273] The acoustic impedance with respect to volume can be defined as follows.

[0274]

Chem.

[0275] Modeling of Acoustic Port The acoustic port can be modeled by assuming that all of the fluid in the port moves essentially as the rigid cylinder reciprocates axially. It is assumed that all of the fluid in the channel moves at the same velocity, that the channel has a constant cross-section, and that the "end effects" due to the fluid entering and leaving the channel are ignored. Equation

[0276]

Chem.

[0277] When assuming laminar friction of [], the frictional force acting on the mass of the fluid in the channel can be described as follows.

[0278]

Chem.

[0279] Then, a second-order differential equation can be described for the dynamics of the fluid in the channel.

[0280]

Chem.

[0281] Or, with respect to the volume flow rate, it is as follows.

[0282]

Chem.

[0283] Then, the acoustic impedance of the channel can be described as follows.

[0284] [Chemical formula]

[0285] System transfer function Using the volume and port dynamics defined above, the volume sensor assembly 148 can be represented by the following set of simultaneous equations. (k = speaker, r = resonator)

[0286] [Chemical formula]

[0287] When p0 is treated as the input to be substituted into

[0288] [Chemical formula]

[0289] one equation can be eliminated.

[0290] [Chemical formula]

[0291] Inter-system transfer function The relationship between the speaker volume and the variable volume can be called the inter-system transfer function. This transfer function can be derived from the above equations and is as follows.

[0292] [Chemical formula]

[0293] In the formula,

[0294] [Chemical formula]

[0295] Referring also to FIG. 97, the board diagram of Equation 23 is shown.

[0296] The difficulty of this relationship is that the complex poles depend on the variable volume V2 and the reference volume V1. A change in the average position of the speaker may result in an error in the estimated volume.

[0297] Transfer function between ports The relationship between the two volumes on both sides of the acoustic port can be called the transfer function between ports. This relationship is as follows.

[0298]

Chemical formula

[0299] This is shown graphically in FIG. 98.

[0300] This relationship has the advantage that the poles depend only on the variable volume and not on the reference volume. However, there is a difficulty in that the resonance peak is actually due to a zero inversion according to the reference volume pressure. Therefore, the measured pressure value in the reference chamber has a low amplitude near resonance, potentially increasing the noise of the measured value.

[0301] Transfer function between speakers Pressure can also be measured from both sides of the speaker. This is called the transfer function between speakers.

[0302]

Chemical formula

[0303] This is shown graphically in FIG. 99.

[0304] This transfer function has a set of complex zeros in addition to a set of complex poles.

[0305] Looking at the limit of this transfer function,

[0306]

Chemical formula

[0307] Therefore,

[0308]

Chem.

[0309] and

[0310]

Chem.

[0311] Therefore,

[0312]

Chem.

[0313] is.

[0314] Resonance quality factor and peak response The quality of resonance is the ratio of the stored energy to the power loss that can be increased by the resonance frequency. For a pure quadratic system, the quality factor can be expressed as a function of the damping ratio.

[0315]

Chem.

[0316] The ratio of the peak response to low - frequency resonance can also be described as a function of the damping ratio.

[0317]

Chem.

[0318] This can occur at the damped natural frequency.

[0319]

Chem.

[0320] Volume Estimation Volume Estimation Using Inter-Port Phase The variable volume (i.e., within the volume sensor chamber 620) can also be estimated using the inter-port phase. The transfer function of the pressure ratio across the resonant ports can be as follows.

[0321] [Chemical Formula]

[0322] At the 90° phase point, ω = ω n wherein, in the formula,

[0323] [Chemical Formula]

[0324] is.

[0325] The resonant frequency can be determined on a physical system using several methods. To find the 90° phase point, a phase-locked loop may be employed, and this frequency may correspond to the natural frequency of the system. Alternatively, the resonant frequency may be calculated using the phases at any two frequencies.

[0326] The phase φ at a given frequency satisfies the following relational expression.

[0327] [Chemical Formula]

[0328] wherein, in the formula,

[0329] [Chemical Formula]

[0330] It is.

[0331] When obtaining the value of V2, the following equation is obtained.

[0332]

Chemical formula

[0333] Therefore, in order to calculate the natural frequency of the system, the ratio of the phases at two different frequencies ω1 and ω2 can be used.

[0334]

Chemical formula

[0335] For calculation efficiency, it is not actually necessary to calculate the phase. The ratio of the real part and the imaginary part of the response (tanφ) is sufficient.

[0336] When rewriting Equation 33 with respect to the variable volume, the following equation is obtained.

[0337]

Chemical formula

[0338] Volume estimation using a swept sine wave The resonance frequency of the system can be estimated using swept sine wave system identification. In this method, the response of the system to the sine wave pressure fluctuation can be obtained at a number of different frequencies. Then, this frequency response data can be used to estimate the system transfer function using linear regression.

[0339] The transfer function of the system can be expressed as a rational function of s. The general case is represented below for a transfer function with an nth-order numerator and an mth-order denominator. N and D are the coefficients of the numerator and denominator, respectively. The equation is normalized so that the leading coefficient of the denominator is 1.

[0340]

Chem.

[0341] or

[0342]

Chem.

[0343] This equation can be rewritten as follows.

[0344]

Chem.

[0345] Expressing this sum in matrix notation gives the following.

[0346]

Chem.

[0347] Where k is the number of data points collected in the swept sine wave. For simplicity of notation, this equation can be summarized using vectors.

[0348]

Chem.

[0349] Where y is k×1, x is k×(m + n - 1), and c is (m + n - 1)×1. Then the coefficients can be determined using the least squares method. The error function can be described as follows.

[0350]

Chem.

[0351] The function to be minimized is the weighted square of the error function. W is a k×k diagonal matrix.

[0352]

Chem.

[0353] Since the two central terms are scalars, the transpose can be ignored.

[0354]

Chem.

[0355] In all of these cases, it may be necessary to use the complex conjugate transpose. This method can result in complex coefficients, but the process may be modified to ensure that all coefficients are real. The least squares minimization may be modified to produce only real coefficients if the error function is changed to the following equation.

[0356]

Chem.

[0357] Therefore, the coefficients can be obtained by the following relational expressions.

[0358]

Chem.

[0359] Solution Method for Second-Order Systems For a system with a zero-order numerator and a second-order denominator, as represented by the transfer function, it is as follows.

[0360]

Chem.

[0361] The coefficients of this transfer function can be obtained based on the equations determined in the previous section.

[0362]

Chem.

[0363] In the formula,

[0364]

Chem.

[0365] To simplify the algorithm, some of the terms can be combined.

[0366]

Chem.

[0367] In the formula,

[0368]

Chem.

[0369] To obtain the expression for D with respect to the complex response vector G and the natural frequency s = jω, X can be separated into its real and imaginary parts.

[0370]

Chem.

[0371] Next, the real and imaginary parts of the above expression for D can be as follows.

[0372]

Chem.

[0373] Combining these terms results in the final expression for the D matrix that may contain only real values.

[0374]

Chem.

[0375] The same approach can be taken to obtain the expression for the b vector with respect to G and ω.

[0376] The real and imaginary parts of y are as follows.

[0377]

Chemical formula

[0378] Combining the real and imaginary parts results in the following expression for the b vector.

[0379]

Chemical formula

[0380] The next step is to invert the D matrix. Since the matrix is symmetric and positive definite, the number of calculations required to find the inverse is reduced from that for a general 3×3 case.

[0381] The general formula for the inverse matrix is as follows.

[0382]

Chemical formula

[0383] When D is expressed as follows,

[0384]

Chemical formula

[0385] Then, the adjoint matrix can be described as follows.

[0386]

Chemical formula

[0387] Due to symmetry, only the upper diagonal matrix may need to be calculated.

[0388] Then, by using the zero elements in the original array, the determinant can be calculated for the adjoint matrix.

[0389]

Chemical Formula

[0390] Finally, the inverse of D can be described as follows.

[0391]

Chemical Formula

[0392] Since we are trying to solve the following equation,

[0393]

Chemical Formula

[0394] Therefore,

[0395]

Chemical Formula

[0396] The final step is to obtain a quantitative assessment of how well the data fits the model. Therefore, the original equation for the error is as follows.

[0397]

Chemical Formula

[0398] This can be expressed as follows in terms of the D matrix, as well as the b and c vectors.

[0399] [Chemistry]

[0400] In the formula,

[0401] [Chemistry]

[0402] The model fitting error can also be used to detect sensor failures.

[0403] Alternative solution for a second-order system

[0404] [Chemistry]

[0405] Or

[0406] [Chemistry]

[0407] This equation can be rewritten as follows.

[0408] [Chemistry]

[0409] Applying this sum to matrix notation results in the following.

[0410] [Chemistry]

[0411] For a system with a zero-order numerator and a second-order denominator, as represented by the transfer function,

[0412] [Chemistry]

[0413] The coefficients of this transfer function can be obtained based on the equations obtained in the previous section.

[0414]

Chemical formula

[0415] In the formula,

[0416]

Chemical formula

[0417] In order to simplify the algorithm, some of the terms can be combined.

[0418]

Chemical formula

[0419] In the formula,

[0420]

Chemical formula

[0421] To obtain the equation for D with respect to the complex response vector G and the natural frequency s = jω, X can be separated into its real and imaginary parts.

[0422]

Chemical formula

[0423] Next, the real and imaginary parts of the aforementioned equation for D can be as follows.

[0424]

Chemical formula

[0425] Combining these terms results in a final expression for the D matrix that can contain only real values.

[0426]

Chemical formula

[0427] The same approach can be taken to find the expression for the b vector with respect to G and ω.

[0428] The real and imaginary parts of y are as follows.

[0429]

Chemical formula

[0430] Combining the real and imaginary parts results in an expression for the b vector as follows.

[0431]

Chemical formula

[0432] Implementation of Acoustic Volume Sensing Collection of Frequency Response Data and Calculation of Complex Response To implement the volume sensor assembly 148, the volume sensor assembly 148 should determine the relative responses of the reference microphone 626 and the invariant volume microphone 630 to the sound waves set by the speaker assembly 622. This may be achieved by driving the speaker assembly 622 with a sine wave output at a known frequency. Next, the complex responses of the microphones 626, 630 may be found at that drive frequency. Finally, the relative responses of the microphones 626, 630 are found and may be corrected for alternating sampling, for example, by an analog-to-digital converter (i.e., ADC).

[0433] In addition, the total signal variance may be calculated and compared to the variance of the pure tone extracted using the discrete Fourier transform (i.e., DFT). This can provide a measure of how much of the signal power is due to noise sources or distortion. The present value may then be used to reject bad measurements and iterate.

[0434] Calculation of the Discrete Fourier Transform The signal from the microphone may be sampled in synchronization with the output to the speaker assembly 622 such that a fixed number of points N are taken per wavelength. The measured signal at each point of the wavelength may be summed over an integral number of wavelengths M and stored in an array x by the ISR for processing after all data for that frequency has been collected.

[0435] The DFT may be performed on the data at integer values corresponding to the drive frequency of the speaker. The general formula for the first harmonic of the DFT is as follows.

[0436]

Chemical Formula

[0437] The product MN may be the total number of points, and a factor of 2 may be added so that the real and imaginary parts resulting from the solution match the amplitude of the sine wave.

[0438]

Chemical Formula

[0439] The real part of this equation may be as follows.

[0440]

Chemical Formula

[0441] To reduce the number of calculations required to compute the DFT, the symmetry of the cosine function may be utilized. The foregoing equation may be equivalent to the following equation.

[0442]

Chem.

[0443] Similarly, for the imaginary part of the equation,

[0444]

Chem.

[0445] This can be expressed as follows.

[0446]

Chem.

[0447] The variance of this signal can be calculated as follows.

[0448]

Chem.

[0449] The maximum possible values of the real and imaginary parts of x may be 2 11 which corresponds to half of the AD range. The maximum value of the sound variance can be half of the square of the AD range, 2 21 and can be.

[0450] Calculation of signal variance The pseudo-variance of the signal can be calculated using the following relational expression.

[0451]

Chem.

[0452] The results may be in terms of the square of the AD count. Since the signal is averaged over M periods before the variance is calculated over N samples for the "average" period, this may be only a "pseudo-variance". However, this can be a useful measure for finding out whether the "average" signal appears like a sine wave at the expected frequency. This may be done by comparing the overall signal variance with the variance of the sine wave found by discrete Fourier transform.

[0453] The sum may be approximately

[0454]

Chemical formula

[0455] for a 12-bit ADC. If N < 2 7 = 128 and M < 2 6 = 64, the sum will be less than 2 43 and may be stored as a 64-bit integer. The maximum possible value of the variance results in values between 0 and 2 12 for each successive sample if the ADC oscillates. Since this can result in a peak variance of

[0456]

Chemical formula

[0457] the result may be stored as a signed 32-bit integer with a maximum of 1 / 2 9 resolution.

[0458] Calculation of the relative microphone response The relative response (G) of microphones 626, 630 can be calculated from the complex responses of the individual microphones.

[0459]

Chemical formula

[0460] [Chemistry]

[0461] The denominator of either equation can be expressed with respect to the reference sound variance calculated in the previous section as follows.

[0462] [Chemistry]

[0463] Correction of A / D Skew The signals from microphones 626, 630 do not have to be sampled simultaneously. The A / D ISR obtains a total of N samples per wavelength for each of microphones 626, 630, alternating between microphones 626, 630. The result can be

[0464] [Chemistry]

[0465] a phase offset between the two microphones 626, 630.

[0466] To correct this phase offset, a complex rotation can be applied to the relative frequency response calculated in the previous section.

[0467] [Chemistry]

[0468] Reference Model Second-Order and Higher-Order Models Leakage through the seal of the volume sensor chamber 620 (e.g., seal assembly 1404) can be modeled as a second resonance port (e.g., port 1504, Figure 100) connected to an external volume (e.g., external volume 1506, Figure ).

[0469] The simultaneous equations representing the three - chamber configuration can be as follows.

[0470]

Chemical formula

[0471] By applying these equations to the state space, the following equations are obtained.

[0472]

Chemical formula

[0473] The frequency response can be graphically represented in the board diagram shown in FIG. 101 and can also be described in the form of a transfer function.

[0474]

Chemical formula

[0475] By expanding the denominator, the following equation is obtained.

[0476]

Chemical formula

[0477] The air bubbles under the diaphragm material in the variable volume will follow the same dynamic equation as the leakage path. In this case, the diaphragm material can act as a resonant mass rather than a leakage port. Therefore, the equation can be as follows.

[0478]

Chemical formula

[0479] In the formula, m is the mass of the diaphragm, A is the cross - sectional area of the diaphragm that can resonate, and b mis mechanical braking. Equation 106 can be described in terms of volumetric flow rate.

[0480] [Chemical formula]

[0481] Wherein, the volume of the bubble is V3. When V3 << V2, that is, the bubble volume is substantially smaller than the acoustic volume, the transfer function can be simplified to the following equation.

[0482] [Chemical formula]

[0483] Second order with time delay The equation of the volume sensor assembly 148 derived above assumes that the pressure is the same at any location in the acoustic volume. This is only an approximate equation because there is a time delay associated with the propagation of sound waves through the volume. This situation may appear as a time delay or time advance based on the relative positions of the microphone and the speaker.

[0484] The time delay can be represented in the Laplace domain as follows.

[0485] [Chemical formula]

[0486] This results in a system of non-linear equations. However, a first-order Padé approximation of the time delay can be used as follows.

[0487] [Chemical formula]

[0488] This is shown graphically in Figure 102.

[0489] 3-chamber volume estimation The volume sensor assembly 148 may also be configured to use a third reference volume (e.g., reference volume 1508, FIG. 103) connected to a separate resonance port (e.g., port 1510, FIG. 103). This configuration may enable temperature-independent volume estimation. The simultaneous equations representing the three-chamber configuration may be as follows.

[0490]

Chem.

[0491]

Chem.

[0492] By using these equations and obtaining the values of the transfer function across each of the resonance ports, the following equations result.

[0493]

Chem.

[0494] where

[0495]

Chem.

[0496]

Chem.

[0497] where

[0498]

Chem.

[0499] The volume of the volume sensor chamber 620 may be estimated as follows, using the ratio of the natural frequencies of the two resonance ports.

[0500]

Chem.

[0501] Equation 120 illustrates that the volume of the volume sensor chamber 620 can be proportional to the reference volume 1508. The ratio of these two volumes (in the ideal model) can depend only on the shape of the resonance port (e.g., port 1510, FIG. 103) and not on temperature.

[0502] Exponential volume model Assume that the outflow through the flow resistance is in the following form.

[0503]

Chem.

[0504] Assuming a fixed input flow rate from the pump chamber, the volume of the volume sensor chamber 620 is based on the following differential equation.

[0505]

Chem.

[0506] This results in the following solution, assuming zero initial volume.

[0507]

Chem.

[0508] Therefore, the output flow velocity flows as follows.

[0509]

Chem.

[0510] The volume delivered during the pump phase can be described as follows.

[0511] [Chemical formula]

[0512] Device calibration Model fitting enables the resonant frequency of the port to be extracted from the sine wave sweep data. The next step is to relate this value to the delivery volume. The ideal relationship between the resonant frequency and the delivery volume is expressed as follows.

[0513] [Chemical formula]

[0514] Since the speed of sound varies with temperature, it may be useful to separate the temperature effect.

[0515] [Chemical formula]

[0516] Next, the volume can be expressed as a function of the measured resonant frequency and temperature.

[0517] [Chemical formula]

[0518] where c is the calibration constant

[0519] [Chemical formula] [[ID=5�]]

[0520] is.

[0521] Implementation details End effect Air resonating within the port (e.g., port assembly 624) can extend into the acoustic volume at the end of each vibration. The distance the air extends can be estimated based on the basic volume sensor assembly equation. For a given acoustic volume, the distance the air extends into the volume can be expressed as a function of pressure and port cross-sectional area.

[0522]

Chem.

[0523] Assuming the following values,

[0524]

Chem.

[0525] Thus, the air extends approximately 1.9 mm into the acoustic chamber.

[0526] Dimensions of V1 (i.e., fixed volume) relative to V2 (i.e., variable volume)

[0527] The dimensions of V1 (e.g., fixed volume 1500) may require a trade-off of the acoustic volume with the relative position of the poles and the zeros in the transfer function. The transfer functions for both V1 and V2 (e.g., variable volume 1502) with respect to the volume displacement of the speaker assembly 622 are shown below.

[0528]

Chem.

[0529] Wherein,

[0530]

Chem.

[0531] As V1 is increased, the gain can decrease and the speaker may be driven at a higher amplitude to obtain the same sound pressure level. However, increasing V1 may also have the advantage of moving the complex zero in the p1 transfer function towards the complex pole. In the limiting case where V1→∞, α→1 and there is pole-zero cancellation and a flat response. Therefore, increasing V1 can reduce both resonance and notch in the p1 transfer function and move the p2 pole towards ω n which may result in less sensitivity to measurement errors when calculating the p2 / p1 transfer function.

[0532] Figure 104 is a graphical representation of the following equation.

[0533]

Chemical formula

[0534] Figure 105 is a graphical representation of the following equation.

[0535]

Chemical formula

[0536] Aliasing Higher frequencies can be aliased downwards to the frequency of interest, and the aliased frequencies can be expressed as follows.

[0537]

Chemical formula

[0538] where f s is the sampling frequency, f n is the frequency of the noise source, n is a positive integer, and f is the aliased frequency of the noise source.

[0539] The demodulation routine may effectively remove noise except for a specific frequency of demodulation. When the sampling frequency is dynamically set to be a fixed multiple of the demodulation frequency, the frequencies of the noise that can be aliased downward to the demodulation frequency may be a fixed set of harmonics of its fundamental frequency.

[0540] For example, when the sampling frequency is 8 times the demodulation frequency, the noise frequencies that can be aliased downward to that frequency are as follows.

[0541]

Chemical formula

[0542] where

[0543]

Chemical formula

[0544] For β = 16, the following series results.

[0545]

Chemical formula

[0546] Performance Sensitivity to temperature The sensitivity to temperature can be divided into gain change and noise change. When the temperature deviates by a factor of dT, the resulting gain error can be the following equation.

[0547]

Chemical formula

[0548] Therefore, when the same temperature is used for both sine wave sweeps, the error in temperature measurement may appear as a gain change to the system.

[0549] [Chemical formula]

[0550] Thus, for a temperature error of 1°K, the resulting volume error can be 0.3% at 298°K. This error can include both the error of the temperature sensor and the difference between the sensor temperature and the temperature of the air within the volume sensor assembly 148.

[0551] However, the measurements may be more susceptible to the effects of temperature measurement noise. Temperature changes during a differential sine wave sweep may result in an error that appears more like an offset rather than a gain change.

[0552] [Chemical formula]

[0553] Thus, if the measured value varies by only 0.1K during two measurement sine wave sweeps, the difference can be 0.012 uL. Thus, it may be more effective to use a consistent temperature estimate for each delivery rather than performing separate temperature measurements for each sine wave sweep (as shown in FIG. 107).

[0554] The LM73 temperature sensor has a published accuracy of + / -1°C and a resolution of 0.03°C. Further, the LM73 temperature sensor is thought to consistently have an initial transient of approximately 0.3°C that requires approximately five sine wave sweeps to level out (as shown in FIG. 108).

[0555] The aforementioned injection pump assemblies (e.g., injection pump assemblies 100, 100’, 400, 500) provide discrete delivery of injectable fluid. Thus, the aforementioned injection pump assemblies can be modeled in a fully discrete domain (in the manner shown in FIG. 109), which can be summarized by the following equation.

[0556] [Chemical formula]

[0557] The discrete-time PI regulator may function according to the following equation.

[0558]

Chemical formula

[0559] The AVS system described above operates by comparing the acoustic responses in the fixed volume 1500 and the variable volume 1502 with the speaker drive input and extracting the volume of the variable volume 1502. Accordingly, there are microphones (e.g., microphones 626, 630) in contact with each of these separate volumes. To detect the presence or absence of the disposable housing assembly 114, the response of the variable volume microphone 630 may also be used in a more general way. Specifically, if the disposable housing assembly 114 is not attached to the variable volume 1502 (i.e., not positioned in proximity), the acoustic response to the speaker drive input should not be substantially sensed at all. However, the response of the fixed volume 1500 should remain related to the speaker input. Thus, simply by ensuring that both microphones exhibit an acoustic response, microphone data may be used to determine whether the disposable housing assembly 114 is attached. If the microphone 626 (i.e., the microphone positioned in proximity to the fixed volume 1500) exhibits an acoustic response and the microphone 630 (i.e., the microphone positioned in proximity to the variable volume 1502) does not exhibit an acoustic response, it can be reasonably inferred that the disposable housing assembly 114 is not attached to the reusable housing assembly 102. Note that a failure of the variable volume microphone 630 may result in midrange measurements that are nearly indistinguishable from the microphone responses expected when the disposable housing assembly 114 is not attached, so a failure of the variable volume microphone 630 may also indicate a non-attached disposable housing assembly 114. For the following discussion, the following names may be used.

[0560]

Table 6

[0561] As part of the demodulation routine employed in each frequency response calculation, the minimum and maximum measured values of both the fixed volume microphone 626 and the variable volume microphone 630 can be calculated. The sum of these maximum and minimum values can be calculated for both the microphone 626 and the microphone 630 over the entire sine wave sweep (as discussed above).

[0562]

Chemical formula

[0563]

Chemical formula

[0564] The difference between these two sums can be simplified as follows.

[0565]

Chemical formula

[0566] Where δ can be divided by the number of sine wave sweeps to obtain the average minimum / maximum difference of the sine wave sweep (which is then compared to a threshold value), and the threshold value can be equivalently multiplied by N for computational efficiency. Thus, the basic available detection algorithm can be defined as follows.

[0567]

Chemical formula

[0568] The additional condition that the maximum / minimum difference is greater than a threshold is a check performed to ensure that the failed speaker is not the cause of the received acoustic response. This algorithm may be repeated for any sine wave sweep, and thus, for example, enables the detachment of the disposable housing assembly 114 to be detected within at most two consecutive sweeps (i.e., in the worst-case scenario where the disposable housing assembly 114 is removed during the second half of an ongoing sine wave sweep).

[0569] Thresholding for the aforementioned algorithm may be based entirely on numerical evidence. For example, an investigation of typical minimum / maximum response differences may show that no individual difference is less than 500 ADC counts. Thus, all data investigated while the disposable housing assembly 114 is detached from the reusable housing assembly 102 may show all minimum / maximum response differences as being sufficiently less than 500 ADC counts. Thus, the threshold for δ may be set to T = 500.

[0570] The volume sensor assembly 148 has been described above as being used within an injection pump assembly (e.g., injection pump assembly 100), but other configurations are possible and are considered to be within the scope of the present disclosure, so this is for illustrative purposes only and is not intended to be limiting of the present disclosure. For example, the volume sensor assembly 148 may be used within a process control environment, for example, to control the quantity of chemicals mixed together. Alternatively, the volume sensor assembly 148 may be used within a beverage dispensing system, for example, to control the quantity of ingredients mixed together.

[0571] The volume sensor assembly 148 has been described above as utilizing a port (e.g., port assembly 624) as a resonator, but other configurations are possible and are considered within the scope of the present disclosure, so this is for illustrative purposes only. For example, a solid mass (not shown) may be suspended within the port assembly 624 and may function as a resonator for the volume sensor assembly 148. Specifically, a mass for the resonator (not shown) may be suspended on a diaphragm (not shown) spanning the port assembly 624. Alternatively, the diaphragm itself (not shown) may serve the role of the mass for the resonator. The natural frequency of the volume sensor assembly 148 may be a function of the volume of the variable volume 1502. Thus, if the natural frequency of the volume sensor assembly 148 can be measured, the volume of the variable volume 1502 can be calculated.

[0572] The natural frequency of the volume sensor assembly 148 may be measured in a number of different ways. For example, a time-varying force may be applied to the diaphragm (not shown), and the relationship between the force and the motion of the diaphragm (not shown) may be used to estimate the natural frequency of the volume sensor assembly 148. Alternatively, the mass (not shown) may be perturbed and then vibrated. Then, the unforced motion of the mass (not shown) may be used to calculate the natural frequency of the volume sensor assembly 148.

[0573] The force applied to the resonant mass (not shown) may be achieved in a variety of ways, and examples thereof may include, but are not limited to, the following. · The speaker assembly 622 may generate a time-varying pressure within the fixed volume 1500. · The resonant mass (not shown) may be a piezoelectric material that reacts to a time-varying voltage / current. · The resonant mass (not shown) may be a voice coil that reacts to a time-varying voltage / current.

[0574] The force applied to the resonant mass may be measured in a variety of ways, and examples thereof may include, but are not limited to, the following. · Measure the pressure in the fixed volume. · The resonance mass (not shown) may be a piezoelectric material. · The strain gauge may be connected to a diaphragm (not shown) or other structural member that supports the resonance mass (not shown).

[0575] Similarly, the displacement of the resonance mass (not shown) may be estimated by measuring the pressure in the variable volume or directly measured in various ways, and its embodiments may include, but are not limited to, the following. · Via a piezoelectric sensor. · Via a capacitance sensor. · Via an optical sensor. · Via a Hall effect sensor. · Via a potentiometer (time-varying impedance) sensor. · Via an inductive sensor. · Via a linear variable differential transformer (LVDT).

[0576] Furthermore, the resonance mass (not shown) may be integrated with either a force-type sensor or a displacement-type sensor (i.e., the resonance mass (not shown) may be made of a piezoelectric material).

[0577] The application of force and the measurement of displacement may be achieved by a single device. For example, a piezoelectric material may be used for the resonance mass (not shown), and a time-varying voltage / current may be applied to the piezoelectric material to generate a time-varying force. The resulting voltage / current applied to the piezoelectric material may be measured, and the transfer function between the two may be used to estimate the natural frequency of the volume sensor assembly 148.

[0578] As described above, the resonance frequency of the volume sensor assembly 148 can be estimated using sweep sine wave system identification. Specifically, the aforementioned model fitting may enable the resonance frequency of the port assembly to be extracted from the sine wave sweep data, which can then be used to determine the delivery volume. The ideal relationship between the resonance frequency and the delivery volume can be expressed as follows.

[0579] [Chemistry]

[0580] Since the speed of sound varies with temperature, it may be useful to separate the temperature effect.

[0581] [Chemistry]

[0582] Therefore, the volume can be expressed as a function of the measured resonance frequency and temperature.

[0583] [Chemistry]

[0584] where c is a calibration constant

[0585] [Chemistry] is.

[0586] Next, the infusion pump assembly 100 may compare this calculated volume V2 (i.e., representing the actual volume of injectable fluid delivered to the user) with a target volume (i.e., representing the amount of fluid that should have been delivered to the user). For example, assume that the infusion pump assembly 100 is one that delivers a 0.100 unit base dose of injectable fluid to the user every 30 minutes. Further, assume that upon achieving such delivery, the volume sensor assembly 148 indicates a calculated volume V2 of 0.095 units of injectable fluid (i.e., representing the actual volume of injectable fluid delivered to the user).

[0587] When calculating volume V2, the infusion pump assembly 100 may first determine the volume of fluid within the volume sensor chamber 620 prior to administration of a dose of injectable fluid, and may later determine the volume of fluid within the volume sensor chamber 620 after administration of a dose of injectable fluid. The difference between these two measurements indicates V2 (i.e., the actual volume of injectable fluid delivered to the user). Thus, V2 is a differential measurement value.

[0588] V2 can be the total void across the diaphragm in a variable volume chamber. The actual fluid delivery to the patient can be the difference in V2 from when the chamber was full until after the measurement valve is opened and the chamber is emptied. V2 may not be the directly delivered volume. For example, an air volume may be measured, and a series of differential measurements may be taken. For an occlusion, a null measurement may be taken, the chamber may be filled, a full measurement may be obtained, and then a final measurement may be obtained after the outlet valve is opened. Thus, the difference between the first measurement and the second measurement can be the amount delivered, and the difference between the second measurement and the third measurement can be the amount delivered to the patient.

[0589] Thus, the electrical control assembly 110 may determine that the delivered injectable fluid is 0.005 units less than required. In response to this determination, the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that any additional required dose can be delivered. Alternatively, the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that an additional dose can be dispensed with the next dose. Thus, during administration of the next 0.100 unit dose of injectable fluid, the output command to the pump may be modified based on the difference between the targeted and delivered amounts.

[0590] Referring also to FIG. 110, one particular implementation of a control system for controlling the amount of injectable fluid currently being injected is shown, at least in part, based on the amount of injectable fluid previously administered. Specifically, continuing with the foregoing example, for illustrative purposes, assume that the electrical control assembly 110 requests delivery of a 0.100 unit dose of injectable fluid to the user. Thus, the electrical control assembly 110 may provide to the volume controller 1602 a target differential volume signal 1600 (identifying a partial baseline dose of 0.010 units of injectable fluid per cycle of the shape memory actuator 112). Thus, in this particular example, the shape memory actuator 112 may need to be cycled 10 times (i.e., 10 cycles × 0.010 units / cycle = 0.100 units) to achieve the desired baseline dose of 0.100 units of injectable fluid. In turn, the volume controller 1602 may provide an “on time” signal 1606 to the SMA (i.e., shape memory actuator) controller 1608. Also, a battery voltage signal 1610 is provided to the SMA controller 1608.

[0591] Specifically, the shape memory actuator 112 may be controlled by varying the amount of thermal energy (e.g., joules) applied to the shape memory actuator 112. Thus, if the voltage level of the battery 606 is reduced, the amount of joules applied to the shape memory actuator 112 may also be reduced over a defined period. Conversely, if the voltage level of the battery 606 is increased, the amount of joules applied to the shape memory actuator 112 may also be increased over a defined period. Thus, by monitoring the voltage level of the battery 606 (via the battery voltage signal 1610), the type of signal applied to the shape memory actuator 112 may be varied to ensure that an appropriate amount of thermal energy is applied to the shape memory actuator 112 regardless of the battery voltage level.

[0592] The SMA controller 1608 may process the "on-time" signal 1606 and the battery voltage signal 1610 to determine an appropriate SMA drive signal 1612 to apply to the shape memory actuator 112. One example of the SMA drive signal 1612 is a series of binary pulses where the amplitude of the SMA drive signal 1612 essentially controls the stroke length of the shape memory actuator 112 (and thus the pump assembly 106), and the duty cycle of the SMA drive signal 1612 essentially controls the stroke rate of the shape memory actuator 112 (and thus the pump assembly 106). Further, since the SMA drive signal 1612 indicates a differential volume (i.e., the volume injected during each cycle of the shape memory actuator 112), the SMA drive signal 1612 may be integrated by the discrete time integrator 1614 to generate a volume signal 1616 that indicates the total amount of injectable fluid injected over a plurality of cycles of the shape memory actuator 112. For example, to inject 0.100 units of injectable fluid (as described above), it may take 10 cycles of the shape memory actuator 112 (at 0.010 units per cycle), so the discrete time integrator 1614 may integrate the SMA drive signal 1612 over these 10 cycles to determine the total amount of injectable fluid injected (as represented by the volume signal 1616).

[0593] The SMA drive signal 1612 can, for example, cause the pump assembly 106 to operate over one cycle, resulting in the filling of the volume sensor chamber 620 included within the volume sensor assembly 148. Next, the infusion pump assembly 100 may make a first measurement of the quantity of fluid contained within the volume sensor chamber 620 (as described above). Further, as described above, the measurement valve assembly 610 may later be energized to cause all or a portion of the fluid within the volume sensor chamber 620 to be delivered to the user. Next, the infusion pump assembly 100 may make a measurement of the quantity of fluid contained within the volume sensor chamber 620 (as described in the foregoing), and use these two measurements to determine V2, i.e., the actual volume of injectable fluid delivered to the user during the current cycle of the shape memory actuator 112. Once determined, V2 (i.e., as represented by the signal 1618) may be provided (i.e., fed back) to the volume controller 1602 for comparison with the previously received target differential volume.

[0594] Continuing with the foregoing example where the differential target volume was 0.010 units of injectable fluid, assume that V2 (i.e., as represented by the signal 1618) identifies 0.009 units of injectable fluid as having been delivered to the user. Thus, the infusion pump assembly 100 may increase the next differential target volume to 0.011 units to offset the previous 0.001 unit shortfall. Thus, as described above, the amplitude and / or duty cycle of the SMA drive signal 1612 may be increased when delivering the next basal dose of injectable fluid to the user. This process may be repeated over the remaining 9 cycles of the shape memory actuator 112 (as described above), and the discrete time integrator 1614 may continue to integrate the SMA drive signal 1612 (to generate the volume signal 1616) to define the total quantity of injectable fluid delivered to the user.

[0595] Referring also to FIG. 111, one possible embodiment of the volume controller 1602 is shown. In this particular implementation, the volume controller 1602 may include a PI (Proportional Integrator) controller 1650. The volume controller 1602 may include a feedforward controller 1652 for setting an initial “guess” regarding the “on-time” signal 1606. For example, for the situation described above where the target differential volume signal 1600 identifies a partial basal dose of 0.010 units of fluid injectable per cycle of the shape memory actuator 112, the feedforward controller 1652 may define, for example, an initial “on-time” of 1 millisecond. The feedforward controller 1652 may include, for example, a look-up table that defines the initial “on-time” based at least in part on the target differential volume signal 1600. The volume controller 1602 may further include a discrete-time integrator 1654 for integrating the target differential volume signal 1600 and a discrete-time integrator 1656 for integrating V2 (i.e., as represented by the signal 1618).

[0596] Referring also to FIG. 112, one possible embodiment of the feedforward controller 1652 is shown. In this particular implementation, the feedforward controller 1652 may define a constant signal 1658 and may include an amplifier 1660 (e.g., a unity gain amplifier), the output of which may be summed with the constant signal 1658 at the summing node 1662. The resulting sum signal (i.e., signal 1664) may be provided, for example, as an input signal to a look-up table 1666, which may be processed to generate the output signal of the feedforward controller 1652.

[0597] As described above, the pump assembly 106 may be controlled by the shape memory actuator 112. Further, as described above, the SMA controller 1608 may process the “on-time” signal 1606 and the battery voltage signal 1610 to determine an appropriate SMA drive signal 1612 to apply to the shape memory actuator 112.

[0598] Referring also to FIGS. 113 - 114, one particular implementation of the SMA controller 1608 is shown. As described above, the SMA controller 1608 may respond to the “on - time” signal 1606 and the battery voltage signal 1610 and may provide an SMA drive signal 1612 to the shape memory actuator 112. The SMA controller 1608 may include a feedback loop (including a unit delay 1700), and its output may be multiplied by the battery voltage signal 1610 in a multiplier 1702. The output of the multiplier 1702 may be amplified, for example, by a unity - gain amplifier 1704. The output of the multiplier 1704 may be applied to the negative input of an adder node 1706 (to which the “on - time” signal 1606 is applied). The output of the adder node 1706 may be amplified (for example, via a unity - gain amplifier 1708). The SMA controller may also include a feed - forward controller 1710 (similar to the feed - forward controller 1652 of the volume controller 1602, see FIG. 112) to provide an initial value of the SMA drive signal 1612. The output of the feed - forward controller 1710 may be summed at an adder node 1712 with the output of the amplifier 1708 and an integral representation of the output of the amplifier 1708 (i.e., signal 1714) to form the SMA drive signal 1612.

[0599] The SMA drive signal 1612 may be provided to a control circuit that achieves the application of a force to the shape memory actuator 112. For example, the SMA drive signal 1612 may be applied to a switching assembly 1716 that can selectively apply a current signal 1718 (supplied from the battery 606) and / or a fixed signal 1720 to the shape memory actuator. For example, the SMA drive signal 1612 may achieve the application of energy (supplied from the battery 606 via the current signal 1718) through the switching assembly 1716 in a manner that achieves the duty cycle defined by the SMA drive signal 1612. A unit delay 1722 may generate a delayed version of the signal applied to the shape memory actuator 112 to form the battery voltage signal 1610 (which may be applied to the SMA controller 1608).

[0600] When applying power to the shape memory actuator 112, the voltage may be applied over a fixed amount of time in a) a fixed load cycle with an unregulated voltage, b) a fixed load cycle with a regulated voltage, c) a variable load cycle based on the measured current value, d) a variable load cycle based on the measured voltage value, and e) a variable load cycle based on the square of the measured voltage value. Alternatively, the voltage may be applied to the shape memory actuator 112 over a variable amount of time based on the measured impedance.

[0601] When applying an unregulated voltage over a fixed amount of time in a fixed load cycle, inner loop feedback may not be used, and in the fixed load cycle and at the on-time determined by the outer volume loop, the shape memory actuator may be driven.

[0602] When applying a regulated voltage over a fixed amount of time in a fixed load cycle, inner loop feedback may not be used, and in the fixed load cycle and at the on-time determined by the outer volume loop, the shape memory actuator 112 may be driven.

[0603] In a variable constant load cycle based on the measured current value, when applying an unregulated voltage, the actual current applied to the shape memory actuator 112 may be measured, and the load cycle may be adjusted during operation of the shape memory actuator 112 to maintain the correct average current.

[0604] In a variable constant load cycle based on the measured voltage value, when applying an unregulated voltage, the actual voltage applied to the shape memory actuator 112 may be measured, and the load cycle may be adjusted during operation of the shape memory actuator 112 to maintain the correct average voltage.

[0605] In a variable constant load cycle based on the square of the measured voltage value, when an unregulated voltage is applied, the actual voltage applied to the shape memory actuator 112 may be measured, and the load cycle may be adjusted during operation of the shape memory actuator 112 to maintain the square of the voltage at a level necessary to provide a desired level of power to the shape memory actuator 112 (based on the impedance of the shape memory actuator 112).

[0606] Referring also to FIGS. 114A - 114B, other implementations of the SMA controller 1608 are shown. Specifically, FIG. 114A is an electrical circuit diagram that may include a microprocessor and various control loops configured to provide a PWM signal that can open and close a switch assembly. The switch assembly may control the current that can flow through the shape memory actuator. The battery may provide current to the shape memory actuator. Further, 114B discloses a volume controller and an internal shape memory actuator controller. The shape memory actuator controller may provide a PWM signal to a pump, which may be modified based on the battery voltage. This may occur at a fixed on - time, and as a result, the volume may be measured by the volume sensor assembly 148 and fed back to the volume controller.

[0607] In a preferred embodiment, the duty cycle is varied based on the measured battery voltage to provide a fairly consistent power. The duty cycle is adjusted to compensate for lower battery voltage. Battery voltage can change for two reasons: 1) as the battery discharges, the voltage slowly decreases, and 2) when a load is applied to the battery, its voltage gradually drops due to internal impedance. This occurs in any type of system, and is compensated for by adjusting the duty cycle, thus mitigating lower or fluctuating battery voltage. Battery voltage may be measured by a microprocessor. In other systems, 1) the voltage may be regulated (putting a regulator in to maintain the voltage at a stable voltage), or 2) feedback may be based on something else (i.e., motor speed or position, which does not necessarily measure battery voltage).

[0608] Other configurations may be utilized to control the shape memory actuator. For example, A) the shape memory actuator may be controlled at a fixed duty cycle with an unadjusted voltage. As the voltage varies, the repeatability of heating of the shape memory actuator is reduced. B) A fixed duty cycle with an adjusted voltage may be utilized, which compensates for changes in battery voltage. However, adjusting the voltage downward is less energy efficient. C) The duty cycle may be varied based on changes in current (which may require more complex measurement circuitry). D) The duty cycle may be varied based on a measured voltage. E) The duty cycle may be varied based on the square of the current or the square of the voltage divided by the resistance. F) The voltage may be applied for a variable amount of time based on measured impedance (e.g., a Wheatstone gauge (not shown) may be used to measure the impedance). The impedance of the shape memory actuator may be correlated to strain (i.e., how much the SMA moves may be correlated based on its impedance).

[0609] Referring to FIG. 115, as described above, to improve the safety of the infusion pump assembly 100, the electrical control assembly 110 may include two separate and distinct microprocessors, namely, a supervisor processor 1800 and a command processor 1802. Specifically, the command processor 1802 may perform the functions discussed above (e.g., generating the SMA drive signal 1612), and may control the relay / switch assemblies 1804, 1806 that control the functionality of the shape memory actuators 112, 632 (respectively) in this embodiment. The command processor 1802 may receive feedback from the signal regulator 1808 regarding the state (e.g., voltage level) of the voltage signals applied to the shape memory actuators 112, 632. The supervisor processor 1800 may control the relay / switch assembly 1810 independently of the relay / switch assemblies 1804, 1806. Thus, when an infusion event is desired, both the supervisor processor 1800 and the command processor 1802 must agree that the infusion event is appropriate, and both must activate their respective relays / switches. If either the supervisor processor 1800 or the command processor 1802 is unable to activate its respective relay / switch, the infusion event will not occur. Thus, through the supervisor processor 1800 and the command processor 1802, and their required cooperation and concurrency, the safety of the infusion pump assembly 100 is improved.

[0610] The supervisor processor may prevent delivery when the command processor is not supposed to deliver, and may also alert if the command processor fails to deliver when it should. The supervisor processor may deactivate the relay / switch assembly if the command processor activates the wrong switch or attempts to apply power for an excessive length of time.

[0611] The supervisor processor may redundantly calculate how much insulin should be delivered (i.e., double-check the calculations of the command processor). The command processor may determine the delivery schedule, and the supervisor processor may redundantly check these calculations.

[0612] The supervisor may also redundantly hold a profile (delivery profile) in the RAM, so that the command processor can perform correct calculations, but if there is defective RAM, it may produce incorrect results for the commands. The supervisor uses, for example, a local copy of the base profile to double-check.

[0613] The supervisor can double-check the AVS measurements, look at the AVS calculations, and apply safety checks. Double-checking is performed every time AVS measurement values are taken.

[0614] Referring also to FIG. 116, one or more of the supervisor processor 1800 and the command processor 1802 may perform diagnostics on various parts of the infusion pump assembly 100. For example, the voltage dividers 1812, 1814 may be configured to monitor voltages (V1 and V2, respectively) sensed, for example, at the distal end of the shape memory actuator 112. Knowing the signals applied to the relay / switch assemblies 1804, 1810, the values of the voltages V1 and V2 may enable diagnostics to be performed on various components of the circuit shown in FIG. 116 (similar to that shown in the illustrative diagnostic table 1816).

[0615] As described above, as shown in FIGS. 115-116, to improve the safety of the infusion pump assembly 100, the electrical control assembly 110 may include a plurality of microprocessors (e.g., a supervisor processor 1800 and a command processor 1802), each of which may be required to interact and operate simultaneously to achieve delivery of a dose of injectable fluid. If the microprocessors cannot interact / operate simultaneously, delivery of a dose of injectable fluid may fail and one or more alarms may be triggered, thus improving the safety and reliability of the infusion pump assembly 100.

[0616] A master alarm may be utilized to track volume error over time. Thus, if the total error becomes too large, the master alarm may be activated to indicate that there may be something wrong with the system. Thus, the master alarm may indicate the total volume comparison being made and the perceived differences. A typical value of the difference required to activate the master alarm may be 1.00 milliliter. The master alarm may monitor the sum for information leakage (i.e., inaccuracies have a time horizontal axis).

[0617] Referring also to FIGS. 117A-117B, one such illustrative example of such an interaction among a plurality of microprocessors during delivery of a dose of injectable fluid is shown. Specifically, the command processor 1802 may first determine 1900 the initial volume of injectable fluid within the volume sensor chamber 620. The command processor 1802 may then provide 1902 a "pump power request" message to the supervisor processor 1800. Upon receiving 1904 the "pump power request" message, the supervisor processor 1800 may energize 1906, for example, the relay / switch 1810 (and thus energize the shape memory actuator 112), and may transmit 1908 a "pump power on" message to the command processor 1802. Upon receiving 1910 the "pump power on" message, the command processor 1802 may activate 1912 the pump assembly 106 (by energizing, for example, the relay / switch 1804), during which time the supervisor processor 1800 may monitor 1914, for example, the operation of the pump assembly 106.

[0618] When the operation of the pump assembly 106 is completed, the command processor 1802 may provide a "pump power off" message to the supervisor processor 1800 1914. Upon receiving the "pump power off" message 1916, the supervisor processor 1800 may cut the power of the relay / switch 1810 1918 and may provide a "pump power off" message to the command processor 1802 1920. Upon receiving the "pump power off" message 1922, the command processor 1802 may measure the volume of injectable fluid delivered by the pump assembly 106 1924. This may be accomplished by measuring the current volume of fluid in the volume sensor chamber 620 and comparing it to the volume determined previously (at step 1900). When determined 1924, the command processor 1802 may provide a "valve open power request" message to the supervisor processor 1800 1926. Upon receiving the "valve open power request" message 1928, the supervisor processor 1800 may energize the relay / switch 1810 1930 (thus energizing the shape memory actuator 632) and may transmit a "valve open power on" message to the command processor 1802 1932. Upon receiving the "valve open power on" message 1934, the command processor 1802 may actuate the measurement valve assembly 610 (e.g., by energizing the relay / switch 1806) 1936, during which time the supervisor processor 1800 may monitor the actuation of the measurement valve assembly 610, for example 1938.

[0619] When the operation of the measurement valve assembly 610 is completed, the command processor 1802 may provide a "valve power off" message to the supervisor processor 1800 1940. Upon receiving the "valve power off" message 1942, the supervisor processor 1800 may cut the power of the relay / switch 1810 1944 and may provide a "valve power off" message to the command processor 1802 1946.

[0620] Upon receiving the "valve power off" message at 1948, the command processor 1802 may provide a "valve closing power request" message to the supervisor processor 1800 at 1950. Upon receiving the "valve closing power request" message at 1952, the supervisor processor 1800 may energize the relay / switch 1810 at 1954 (and thus energize the shape memory actuator 652), and may transmit a "power on" message to the command processor 1802 at 1956. Upon receiving the "power on" message at 1958, the command processor 1802 may activate a power relay / switch (not shown) configured to energize the shape memory actuator 652 at 1960, during which time the supervisor processor 1800 may monitor the operation of the shape memory actuator 652, for example, at 1962.

[0621] As described above (and with temporary reference to FIGS. 26A, 26B, 27A, 27B, and 28), the shape memory actuator 652 may be moored to the first end using the electrical contact 654. The other end of the shape memory actuator 652 may be connected to the bracket assembly 656. When the shape memory actuator 652 is activated, the shape memory actuator 652 may pull the bracket assembly 656 forward and release the valve assembly 634. Thus, the metering valve assembly 610 may be activated via the shape memory actuator 632. When the metering valve assembly 610 is activated, the bracket assembly 656 may automatically latch the valve assembly 610 in the activated position. By operating the shape memory actuator 652, the bracket assembly 656 may be pulled forward and the valve assembly 634 may be released. Assuming that the shape memory actuator 632 is no longer activated, when the bracket assembly 656 releases the valve assembly 634, the metering valve assembly 610 may enter the inoperative state. Thus, by operating the shape memory actuator 652, the metering valve assembly 610 may enter the inoperative state.

[0622] When the operation of the shape memory actuator 652 is completed, the command processor 1802 may provide a "power off" message to the supervisor processor 1800 at 1964. When receiving the "power off" message at 1966, the supervisor processor 1800 may turn off the power of the relay / switch 1810 at 1968 and may provide a "power off" message to the command processor 1802 at 1970. When receiving the "power off" message at 1972, the command processor 1802 may determine the quantity of the injectable fluid within the volume sensor chamber 620, and thus enable the command processor 1802 to compare this measured quantity with the quantity determined previously (at step 1924) to determine the quantity of the injectable fluid delivered to the user at 1974.

[0623] If the quantity of the injectable fluid delivered to the user at 1974 is less than the quantity of the injectable fluid specified for the basal / bolus injection event, the foregoing procedure may be repeated (via loop 1976).

[0624] Referring to FIG. 118, another exemplary embodiment of the interaction between processors 1800 and 1802 during the scheduling of the dose of injectable fluid is shown. Command processor 1802 may monitor (respectively) for receipt of base scheduling messages or bolus request messages 2000, 2002. Upon receipt of either of these messages 2000, 2002, command processor 1802 may set the desired delivery volume 2004 and provide a "delivery request" message to supervisor processor 1800 2006. Upon receipt of the "delivery request" message 2008, supervisor processor 1800 may verify the volume 2004 defined by command processor 1802 2010. Once verified 2010, supervisor processor 1800 may provide a "delivery approval" message to command processor 1802 2012. Upon receipt of the "delivery approval" message 2014, command processor 1802 may update the controller (e.g., the controller discussed above and illustrated in FIG. 110) 2016 and perform the delivery of the base / bolus dose of injectable fluid 2018. Command processor 1808 may monitor and update the total amount of injectable fluid delivered to the user (as discussed above and illustrated in FIGS. 117A - 117B) 2022. When an appropriate amount of injectable fluid has been delivered to the user, command processor 1802 may provide a "delivery complete" message to supervisor processor 1800 2024. Upon receipt of the "delivery complete" message 2026, supervisor processor 1800 may update the total amount of injectable fluid delivered to the user 2028. If the total amount of injectable fluid delivered to the user 2018 is less than the amount defined above (at step 2004), the injection process discussed above may be repeated (via loop 2030).

[0625] Referring also to FIG. 119, an embodiment of a manner in which supervisor processor 1800 and command processor 1802 may interact while achieving volume measurement via volume sensor assembly 148 (as described above) is shown.

[0626] Specifically, the command processor 1802 may initialize the volume sensor assembly 148 at 2050, begin collecting data from the volume sensor assembly 148 at 2052, and the process may be repeated for each frequency utilized in the aforementioned sine wave sweep. Each time data is collected for a particular sweep frequency, a data point message may be provided from the command processor 1802 at 2054, which may be received by the supervisor processor 1800 at 2056.

[0627] When data collection 2052 is complete for the entire sine wave sweep, the command processor 1802 may estimate the volume of injectable fluid delivered by the injection pump assembly 100 at 2058. The command processor 1802 may provide a volume estimate message to the supervisor processor 1800 at 2060. When this volume estimate message is received at 2062, the supervisor processor 1800 may check (i.e., verify) the volume estimate message at 2064. When checked (i.e., verified), the supervisor processor 1800 may provide a verification message to the command processor 1802 at 2066. When received from the supervisor processor 1800 at 2068, the command processor 1802 may set the measurement state for the dose of injectable fluid delivered by the volume sensor assembly 148.

[0628] As described above and referring temporarily to FIG. 11, various embodiments of the infusion pump assemblies (e.g., infusion pump assemblies 100, 100', 400, 500) discussed above may be configured via a remote control assembly 300. When configurable via the remote control assembly 300, the infusion pump assembly may include a telemetry circuit (not shown) that enables communication (e.g., wired or wireless) between the infusion pump assembly and, for example, the remote control assembly 300, thus enabling the remote control assembly 300 to remotely control the infusion pump assembly. The remote control assembly 300 (which may similarly include a telemetry circuit (not shown) and may be capable of communicating with the infusion pump assembly) may include a display assembly 302 and an input assembly 304. The input assembly 304 may include a slider assembly 306 and switch assemblies 308, 310. In other embodiments, the input assembly may include a jog wheel, multiple switch assemblies, or the like. The remote control assembly 300 may enable a user to program basal and bolus delivery events.

[0629] The remote control assembly 300 may include two processors. One processor (which may include, but is not limited to, a CC2510 microcontroller / RF transceiver available from Chipcon AS (Oslo, Norway), for example) may be dedicated to wireless communication, for example, to...

Claims

【Claim 1】 An injection pump assembly.

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