Fluid connector assembly

Abstract

Supply of fluid connector assemblies. [Solution] Fluid connector assembly. The fluid connector assembly includes a tab portion including a slot and a plug portion slidably connected to the tab portion, the plug portion comprising a fluid path and a disc, the disc configured to seat in the slot, a capture feature located on a first end of the tab portion and configured to interact with a reservoir, and a latch feature located on a second end of the tab portion and configured to interact with and lock onto the reservoir, wherein a force applied to the plug portion can overcome a threshold force and cause the disc to detach from the slot, and the plug portion moves relative to the tab portion.

Description

[Technical Field]

[0001] This application relates in general to fluid delivery systems, and more specifically to injection pump assemblies. [Background technology]

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

[0003] Effective parenteral routes for drug delivery, as well as for other fluids and compounds, include skin puncture with a needle or stylet, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration. Insulin is an example of a therapeutic solution self-injected by millions of people with diabetes. Users of parenteral delivery drugs may benefit from wearable devices that will automatically deliver the required drug / compound over a period of time.

[0004] To achieve this objective, efforts have been made to design portable and wearable devices for the controlled release of therapeutic drugs. Such devices are known to have reservoirs such as cartridges, syringes, or bags, and to be electronically controlled. These devices have numerous drawbacks, including a high failure rate. Reducing the size, weight, and cost of these devices is also an ongoing challenge. In addition, these devices are often applied to the skin, which presents the challenge of frequent repositioning for application. [Overview of the Initiative] [Means for solving the problem]

[0005] One implementation discloses a fluid connector assembly. The fluid connector assembly includes a tab portion including a slot, and a plug portion slidably connected to the tab portion, the plug portion comprising a fluid path and a disc, the disc configured to seat in the slot, a capture feature located on a first end of the tab portion and configured to interact with a reservoir, and a latch feature located on a second end of the tab portion and configured to interact with and lock onto the reservoir, wherein a force applied to the plug portion can overcome a threshold force and cause the disc to detach from the slot, and the plug portion moves relative to the tab portion.

[0006] Some embodiments of this implementation may include one or more of the following features: The tab portion further comprises a recess configured to interact with a reusable housing assembly. The connector includes a tube connected to a plug. The capture feature comprises a bevel. The second end of the tube is connected to a cannula assembly. The tab portion further comprises a tapered tube opening, and the first end of the tube is connected to the tapered tube opening. The underside of the tab portion comprises a core. The core comprises an identification tag. The tab portion comprises an identification tag. The identification tag is an RFID tag. The identification tag is a near-field-readable RFID. The plug further comprises an outlet end portion and a pipe end portion, the outlet end portion further comprising a first stopping feature, and the pipe end portion further comprising a second stopping feature.

[0007] One implementation discloses a fluid connector assembly. The fluid connector assembly includes a tab portion, including a pipe-side and a reservoir-side; a plug portion slidably connected to the tab portion and having a fluid path; a capture feature located on a first end of the tab portion and configured to interact with the reservoir; and a latch feature located on a second end of the tab portion and configured to interact with and lock onto the reservoir, wherein a force applied to the plug portion moves the plug portion relative to the tab portion from an initial position to a final position in the direction of the pipe-side of the tab portion.

[0008] Some embodiments of this implementation may include one or more of the following features: The tab portion further comprises a recess configured to interact with a reusable housing assembly. The connector includes a tube connected to a plug. The capture feature comprises a bevel. The second end of the tube is connected to a cannula assembly. The tab portion further comprises a tapered tube opening, and the first end of the tube is connected to the tapered tube opening. The underside of the tab portion comprises a core. The core comprises an identification tag. The tab portion comprises an identification tag. The identification tag is an RFID tag. The identification tag is a near-field-readable RFID. The plug further comprises an outlet end portion and a pipe end portion, the outlet end portion further comprising a first stopping feature, and the pipe end portion further comprising a second stopping feature.

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

[0010] According to the first implementation, a mountable injection pump assembly is disclosed. The mountable injection pump assembly includes a reservoir for receiving an injectable fluid and a fluid delivery system configured to deliver the injectable fluid from the reservoir to an external injection set. The fluid delivery system includes a controller and a pump assembly for extracting a volume of injectable fluid from the reservoir and providing the volume of injectable fluid to an external injection set, the pump assembly comprising a pump plunger, the pump plunger having a travel distance, the 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 sensor outputs to the controller, and a first valve assembly configured to selectively isolate the pump assembly from the reservoir, the controller receiving the sensor outputs and determining the 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 the first portion of the first valve assembly being positioned within the disposable housing assembly and the second portion of the first valve assembly being positioned within the reusable housing assembly. The wearable infusion pump assembly includes the first portion of the second valve assembly being positioned within the disposable housing assembly and the second portion of the second valve assembly being positioned within the reusable housing assembly. The wearable infusion pump assembly includes a detachable external infusion set configured such that the external infusion set releasably engages with 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 sloped 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 forms part of the reservoir and is connected to 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, the plug receiving portion including a fluid path and being configured to receive a plug on a reservoir, and tubing, where a first end of the tubing is fluidly connected to the fluid path of the plug receiving portion.

[0015] Some embodiments of this implementation may include one or more of the following features: The main body further includes a recess configured to interact with the reusable portion of the injection pump. The second end of the tube is connected to the cannula assembly. The main body 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 main body further includes a locking icon. The underside of the main body includes a core. The core includes an identification tag. The main body includes an identification tag. The identification tag is an RFID tag. The identification tag is a near-field-readable RFID.

[0016] According to one implementation, a clip assembly is disclosed. The clip assembly includes a clip portion and a clip housing portion. The clip housing portion includes a front portion and a rear portion. The rear portion includes at least one protrusion and at least one clip feature, the at least one clip feature securing the clip portion onto the rear portion of the housing. This specification provides, for example, the following items: (Item 1) A fluid connector assembly, The tab section has a slot, A plug portion slidably connected to the tab portion, wherein the plug portion comprises a fluid path and a disc, the disc being configured to seat in the slot, A capture feature located on the first end of the tab portion and configured to interact with the reservoir, A latching feature located on the second end of the tab portion, wherein the latching feature is configured to interact with and lock onto the reservoir, and Equipped with, A fluid connector assembly wherein the force applied to the plug portion overcomes a threshold force, causing the disc to be seated in and out of the slot, and the plug portion moves relative to the tab portion. (Item 2) The fluid connector assembly according to any one of items 1 to 12, wherein the tab portion further comprises a recess, the recess being configured to interact with a reusable housing assembly. (Item 3) The aforementioned capture feature is a fluid connector assembly according to any of items 1 to 12, comprising a slope. (Item 4) A fluid connector assembly according to any one of items 1 to 12, further comprising tubing connected to the plug. (Item 5) A fluid connector assembly according to any one of items 1 to 12, wherein the first end of the tubing is connected to the plug, and the second end of the tubing is connected to the cannula assembly. (Item 6) The lower surface of the aforementioned tab portion comprises a core, as described in any of items 1 to 12, for the fluid connector assembly. (Item 7) The core is a fluid connector assembly according to any one of items 1 to 12, comprising an identification tag. (Item 8) The aforementioned tab portion is a fluid connector assembly as described in any of items 1 to 12, which is equipped with an identification tag. (Item 9) The identification tag is an RFID tag, as described in any of items 1 to 12 of the fluid connector assembly. (Item 10) The fluid connector assembly according to any one of items 1 to 12, wherein the plug further comprises an outlet end portion and a pipe end portion, the outlet end portion further comprising a first stopping feature. (Item 11) The fluid connector assembly according to any one of items 1 to 12, wherein the pipe end portion further comprises a second stopping feature. (Item 12) The identification tag is a near-field communication-readable RFID, as described in any of items 1 to 12 of the fluid connector assembly. (Item 13) A fluid connector assembly, A tab section comprising a pipe side and a reservoir side, A plug portion slidably connected to the tab portion, the plug portion having a fluid path, A capture feature located on the first end of the tab portion and configured to interact with the reservoir, A latching feature located on the second end of the tab portion, wherein the latching feature is configured to interact with and lock onto the reservoir, and Equipped with, A fluid connector assembly wherein the force applied to the plug portion moves the plug portion relative to the tab portion from an initial position to a final position in the direction of the tab portion toward the pipes. (Item 14) The fluid connector assembly according to any one of items 13 to 24, wherein the tab portion further comprises a recess, the recess being configured to interact with a reusable housing assembly. (Item 15) The aforementioned capture feature is a fluid connector assembly according to any of items 13 to 24, which has a slope. (Item 16) A fluid connector assembly according to any one of items 13 to 24, further comprising tubing connected to the aforementioned plug. (Item 17) A fluid connector assembly according to any one of items 13 to 24, wherein the first end of the tubing is connected to the plug, and the second end of the tubing is connected to the cannula assembly. (Item 18) The lower surface of the aforementioned tab portion is a fluid connector assembly according to any of items 13 to 24, comprising a core. (Item 19) The core is a fluid connector assembly as described in any of items 13 to 24, which is equipped with an identification tag. (Item 20) The aforementioned tab portion is a fluid connector assembly as described in any of items 13 to 24, which is equipped with an identification tag. (Item 21) The identification tag is an RFID tag, as described in any of items 13 to 24 of the fluid connector assembly. (Item 22) The identification tag is a near-field communication-readable RFID, as described in any of items 13 to 24 of the fluid connector assembly. (Item 23) The fluid connector assembly according to any one of items 13 to 24, wherein the plug further comprises an outlet end portion and a pipe end portion, the outlet end portion further comprising a first stopping feature. (Item 24) The fluid connector assembly according to any of items 13 to 24, wherein the pipe end portion further comprises a second stopping feature.

[0017] Details of one or more embodiments are described in the accompanying drawings and description below. Other features and advantages will be evident from the description, drawings, and claims. [Brief explanation of the drawing]

[0018] [Figure 1] Figure 1 is a side view of the injection pump assembly. [Figure 2] Figure 2 is a perspective view of the injection pump assembly shown in Figure 1. [Figure 3] Figure 3 is an exploded view of the various components of the injection pump assembly shown in Figure 1. [Figure 4] Figure 4 is a cross-sectional view of the disposable housing assembly of the injection pump assembly shown in Figure 1. [Figure 5] Figures 5A-5C are cross-sectional views of an embodiment of a bulkhead access assembly. [Figure 6] Figures 6A-6B are cross-sectional views of another embodiment of the bulkhead access assembly. [Figure 7] Figures 7A-7B are partial top views of another embodiment of the bulkhead access assembly. [Figure 8] Figures 8A-8B are cross-sectional views of another embodiment of the bulkhead access assembly. [Figure 9]Figure 9 is a perspective view of the injection pump assembly from Figure 1, showing the external injection set. [Figure 10] Figures 10A-10E illustrate multiple Velcro® configurations. [Figure 11A] Figure 11A is an isometric view of an alternative embodiment of the remote control assembly and the injection pump assembly shown in Figure 1. [Figure 11B] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11C] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11D] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11E] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11F] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11G] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11H] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11I] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11J] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11K] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11L]Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11M] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11N] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11O] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11P] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11Q] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 11R] Figures 11A-11R depict various high-level schematics and flowcharts of the injection pump assembly shown in Figure 1. [Figure 12] Figures 12A-12F show multiple display screens rendered by the remote control assembly shown in Figure 11A. [Figure 13] Figure 13 is an isometric view of an alternative embodiment of the injection pump assembly shown in Figure 1. [Figure 14] Figure 14 is an isometric view of the injection pump assembly shown in Figure 13. [Figure 15] Figure 15 is an isometric view of the injection pump assembly shown in Figure 13. [Figure 16] Figure 16 is an isometric view of an alternative embodiment of the injection pump assembly shown in Figure 1. [Figure 17] Figure 17 is a plan view of the injection pump assembly shown in Figure 16. [Figure 18] Figure 18 is a plan view of the injection pump assembly shown in Figure 16. [Figure 19A] Figure 19A is an exploded view of the various components of the injection pump assembly shown in Figure 16. [Figure 19B] Figure 19B is an isometric view of a portion of the injection pump assembly shown in Figure 16. [Figure 20] Figure 20 is a cross-sectional view of the disposable housing assembly of the injection pump assembly shown in Figure 16. [Figure 21] Figure 21 is a diagram of the fluid path within the injection pump assembly shown in Figure 16. [Figure 22] Figures 22A-22C are diagrams of the fluid pathways within the injection pump assembly shown in Figure 16. [Figure 23] Figure 23 is an exploded view of the various components of the injection pump assembly shown in Figure 16. [Figure 24] Figure 24 is a cross-sectional isometric view of the injection pump assembly shown in Figure 16. [Figure 25] Figures 25A-25D are other isometric views of the pump assembly shown in Figure 24. [Figure 26] Figures 26A-26B are isometric views of the measuring valve assembly of the injection pump assembly shown in Figure 16. [Figure 27] Figures 27A-27B are side views of the measuring valve assembly shown in Figures 26A-26B. [Figure 28A] Figures 28A-28D show the measuring valve assembly of the injection pump assembly shown in Figure 16. [Figure 28B] Figures 28A-28D show the measuring valve assembly of the injection pump assembly shown in Figure 16. [Figure 28C] Figures 28A-28D show the measuring valve assembly of the injection pump assembly shown in Figure 16. [Figure 28D] Figures 28A-28D show the measuring valve assembly of the injection pump assembly shown in Figure 16. [Figure 29] Figure 29 is an isometric view of an alternative embodiment of the injection pump assembly shown in Figure 1. [Figure 30] Figure 30 is an isometric view of an alternative embodiment of the injection pump assembly shown in Figure 1. [Figure 31] Figure 31 is another diagram of an alternative embodiment of the injection pump assembly shown in Figure 9. [Figure 32]Figure 32 is an exploded view of another embodiment of the injection pump assembly. [Figure 33] Figure 33 is another exploded view of the injection pump assembly shown in Figure 32. [Figure 34] Figures 34A-34B depict another embodiment of the injection pump assembly. [Figure 35] Figures 35A-35C are top, side, and bottom views of the reusable housing assembly of the injection pump assembly shown in Figure 32. [Figure 36] Figure 36 is an exploded view of the reusable housing assembly shown in Figures 35A-35C. [Figure 37] Figure 37 is an exploded view of the reusable housing assembly shown in Figures 35A-35C. [Figure 38A] Figure 38A is an exploded view of the reusable housing assembly shown in Figures 35A-35C. [Figure 38B] Figures 38B-38D are a top view, side view, and bottom view of one embodiment of a dust cover. [Figure 38C] Figures 38B-38D are a top view, side view, and bottom view of one embodiment of a dust cover. [Figure 38D] Figures 38B-38D are a top view, side view, and bottom view of one embodiment of a dust cover. [Figure 39] Figures 39A-39C are top, side, and bottom views of the electrical control assembly of the reusable housing assembly shown in Figures 35A-35C. [Figure 40] Figures 40A-40C are the top, side, and bottom views of the circuit board of the reusable enclosure assembly shown in Figures 35A-35C. [Figure 41] Figures 41A and 41B are perspective top and bottom views of the substrate shown in Figures 40A and 40C. [Figure 42] Figures 42A-42C are the top, side, and bottom views of the circuit board of the reusable enclosure assembly shown in Figures 35A-35C. [Figure 43] Figures 43A-43B depict the mechanical control assembly of the reusable housing assembly shown in Figures 35A-35C. [Figure 44] Figures 44A-44C depict the mechanical control assembly of the reusable housing assembly shown in Figures 35A-35C. [Figure 45] Figures 45A-45B depict the pump plunger and reservoir valve of the mechanical control assembly in the reusable housing assembly shown in Figures 35A-35C. [Figure 46] Figures 46A–46E depict various diagrams of the plunger pump and reservoir valve of the mechanical control assembly in the reusable housing assembly shown in Figures 35A–35C. [Figure 47] Figures 47A-47B depict the measuring valves of the mechanical control assembly in the reusable housing assembly shown in Figures 35A-35C. [Figure 48] Figure 48 is an exploded view of the disposable housing assembly of the injection pump assembly shown in Figure 32. [Figure 49A] Figure 49A is a plan view of the disposable housing assembly shown in Figure 48. [Figure 49B] Figure 49B is a cross-sectional view of the disposable housing assembly of Figure 49A, obtained along BB. [Figure 49C] Figure 49C is a cross-sectional view of the disposable housing assembly of Figure 49A, obtained along CC. [Figure 50] Figures 50A-50C depict the base portion of the disposable housing assembly shown in Figure 48. [Figure 51] Figures 51A-51C depict the fluid path cover of the disposable housing assembly shown in Figure 48. [Figure 52] Figures 52A-52C depict the membrane assembly of the disposable housing assembly shown in Figure 48. [Figure 53] Figures 53A-53C depict the upper portion of the disposable housing assembly shown in Figure 48. [Figure 54] Figures 54A-54C depict the valve inserts of the disposable housing assembly shown in Figure 48. [Figure 55] Figures 55A-55B depict the locking ring assembly of the injection pump assembly shown in Figure 32. [Figure 56]Figures 56A-56C depict the locking ring assembly of the injection pump assembly shown in Figure 32. [Figure 57] Figures 57-58 are isometric views of the injection pump assembly and filling adapter. [Figure 58] Figures 57-58 are isometric views of the injection pump assembly and filling adapter. [Figure 59] Figures 59-64 show various diagrams of the filling adapter shown in Figure 57. [Figure 60] Figures 59-64 show various diagrams of the filling adapter shown in Figure 57. [Figure 61] Figures 59-64 show various diagrams of the filling adapter shown in Figure 57. [Figure 62] Figures 59-64 show various diagrams of the filling adapter shown in Figure 57. [Figure 63] Figures 59-64 show various diagrams of the filling adapter shown in Figure 57. [Figure 64] Figures 59-64 show various diagrams of the filling adapter shown in Figure 57. [Figure 65] Figure 65 is an isometric view of another embodiment of the filling adapter. [Figure 66] Figures 66-67 illustrate another embodiment of the injection pump assembly and filling adapter. [Figure 67] Figures 66-67 illustrate another embodiment of the injection pump assembly and filling adapter. [Figure 68] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 69] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 70] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 71] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 72] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 73] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 74] Figures 68-74 show various diagrams of the filling adapter shown in Figure 66. [Figure 75] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 76] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 77] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 78] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 79] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 80] Figures 75-80 illustrate various embodiments of the battery charger. [Figure 81] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 82] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 83] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 84] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 85] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 86] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 87] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 88] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 89A] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 89B] Figures 81-89B illustrate various embodiments of the battery charger / docking station. [Figure 90] Figures 90A-90C show various diagrams of the volume sensor assembly included within the injection pump assembly in Figure 1. [Figure 91] Figures 91A-91I show various diagrams of the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 92] Figures 92A-92I show various diagrams of the volume sensor assembly included within the injection pump assembly in Figure 1. [Figure 93] Figures 93A-93I show various diagrams of the volume sensor assembly included within the injection pump assembly in Figure 1. [Figure 94] Figures 94A-94F show various diagrams of the volume sensor assembly included within the injection pump assembly in Figure 1. [Figure 95] Figure 95 is an exploded view of the volume sensor assembly contained within the injection pump assembly shown in Figure 1. [Figure 96] Figure 96 is a diagram of the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 97] Figure 97 is a two-dimensional graph of the performance characteristics of the volume sensor assembly shown in Figure 96. [Figure 98] Figure 98 is a two-dimensional graph of the performance characteristics of the volume sensor assembly shown in Figure 96. [Figure 99] Figure 99 is a two-dimensional graph of the performance characteristics of the volume sensor assembly shown in Figure 96. [Figure 100] Figure 100 is a diagram of the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 101] Figure 101 is a two-dimensional graph of the performance characteristics of the volume sensor assembly shown in Figure 100. [Figure 102] Figure 102 is a two-dimensional graph of the performance characteristics of the volume sensor assembly shown in Figure 100. [Figure 103]Figure 103 is a diagram of the volume sensor assembly included within the injection pump assembly in Figure 1. [Figure 104] Figure 104 is a two-dimensional graph of the performance characteristics of the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 105] Figure 105 is a two-dimensional graph of the performance characteristics of the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 106] Figure 106 is a two-dimensional graph of the performance characteristics of the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 107] Figure 107 is a two-dimensional graph of the performance characteristics of the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 108] Figure 108 is a two-dimensional graph of the performance characteristics of the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 109] Figure 109 is a diagram of the control model for the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 110] Figure 110 is a diagram of the electrical control assembly relative to the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 111] Figure 111 is a diagram of the volume controller relative to the volume sensor assembly contained within the injection pump assembly in Figure 1. [Figure 112] Figure 112 is a diagram of the feedforward controller of the volume controller shown in Figure 111. [Figure 113] Figures 113-114 schematically illustrate the implementation of the SMA controller in the volume controller shown in Figure 111. [Figure 114] Figures 113-114 schematically illustrate the implementation of the SMA controller in the volume controller shown in Figure 111. [Figure 114A] Figures 114A and 114B show alternative implementations of the SMA controller. [Figure 114B] Figures 114A and 114B show alternative implementations of the SMA controller. [Figure 115] Figure 115 schematically illustrates a multiprocessor control configuration that may be included within the injection pump assembly in Figure 1. [Figure 116] Figure 116 is a diagram of a multiprocessor control configuration that may be included within the injection pump assembly of Figure 1. [Figure 117A] Figures 117A-117B schematically illustrate the multiprocessor functionality. [Figure 117B] Figures 117A-117B schematically illustrate the multiprocessor functionality. [Figure 118] Figure 118 schematically illustrates the functionality of multiprocessors. [Figure 119] Figure 119 schematically illustrates the multiprocessor functionality. [Figure 120A] Figure 120A illustrates various software layers in a graph. [Figure 120B] Figures 120B-120C illustrate various state diagrams. [Figure 120C] Figures 120B-120C illustrate various state diagrams. [Figure 120D] Figure 120D graphically illustrates the device interactions. [Figure 120E] Figure 120E graphically illustrates the device interactions. [Figure 121] Figure 121 schematically depicts the volume sensor assembly included within the injection pump assembly in Figure 1. [Figure 122] Figure 122 schematically illustrates the interconnections of the various systems in the injection pump assembly shown in Figure 1. [Figure 123] Figure 123 schematically illustrates the basal bolus injection event. [Figure 124] Figure 124 schematically illustrates the basal bolus injection event. [Figure 125A] Figures 125A-125G illustrate a hierarchical state machine. [Figure 125B] Figures 125A-125G illustrate a hierarchical state machine. [Figure 125C]Figures 125A-125G illustrate a hierarchical state machine. [Figure 125D] Figures 125A-125G illustrate a hierarchical state machine. [Figure 125E] Figures 125A-125G illustrate a hierarchical state machine. [Figure 125F] Figures 125A-125G illustrate a hierarchical state machine. [Figure 125G] Figures 125A-125G illustrate a hierarchical state machine. [Figure 126A] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126B] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126C] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126D] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126E] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126F] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126G] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126H] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126I] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126J] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126K] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126L] Figures 126A-126M illustrate a hierarchical state machine. [Figure 126M] Figures 126A-126M illustrate a hierarchical state machine. [Figure 127] Figure 127 is a schematic diagram illustrating a split-ring resonator antenna. [Figure 128]Figure 128 is a schematic diagram illustrating an example of a medical device configured to utilize a split-ring resonator antenna. [Figure 129] Figure 129 is an illustrative schematic diagram of a split-ring resonator antenna and a transmission line from a medical injection device. [Figure 130] Figure 130 is a graph of the reflection attenuation of a segmented ring resonator antenna before it comes into contact with human skin. [Figure 130A] Figure 130A is a graph of the reflection attenuation of a split-ring resonator antenna while it is in contact with human skin. [Figure 131] Figure 131 is an illustrative schematic diagram of a segmented ring resonator antenna integrated into a device operating in close proximity within a dielectric material. [Figure 132] Figure 132 is a schematic diagram showing the internal and external dimensions of an exemplary embodiment. [Figure 133] Figure 133 is a graph of the reflection attenuation of an undivided ring resonator antenna before contact with human skin. [Figure 133A] Figure 133A is a graph of the reflection attenuation of a split-ring resonator antenna while it is in contact with human skin. [Figure 134] Figures 134A-134C show a top view, a cross-sectional view obtained at section "B", and an isometric view of one embodiment of the upper part of a disposable housing assembly. [Figure 135] Figures 135A and 135B show a top view of one embodiment of the upper part of a disposable housing assembly, and a cross-sectional view obtained at section "B". [Figure 136] Figure 136 shows, using icons, a partially exploded view of one embodiment of a disposable housing assembly and one embodiment of a reusable housing assembly. [Figure 137] Figure 137 shows a cross-sectional view obtained along "A," illustrating a reusable housing assembly oriented above a disposable housing assembly in a release orientation. [Figure 138] Figure 138 shows a cross-sectional view obtained along "A" showing a reusable housing assembly attached to a disposable housing assembly in a release orientation. [Figure 139] Figure 139 shows a cross-sectional view obtained along "A," illustrating a reusable housing assembly attached to a disposable housing assembly in a locked position. [Figure 140A] Figure 140A shows an isometric view of one embodiment of a reusable housing assembly and one embodiment of a dust cover. [Figure 140B] Figure 140B is a top view of one embodiment of the dust cover. [Figure 140C] Figure 140C is a cross-sectional view obtained at "C" as shown in Figure 140B. [Figure 140D] Figure 140D is a cross-sectional view of section "D" as shown in Figure 140C. [Figure 141A] Figure 141A shows one embodiment of a disposable housing assembly. [Figure 141B] Figure 141B is an enlarged section of Figure 141A, as indicated by "B". [Figure 142A] Figure 142A is a top view of one embodiment of a disposable housing assembly. [Figure 142B] Figure 142B is an enlarged section of Figure 142A, as indicated by "B". [Figure 142C] Figure 142C is an enlarged section of Figure 142A, as indicated by "C". [Figure 143A] Figure 143 is a top view of one embodiment of a disposable housing assembly. [Figure 143B] Figure 143B is a cross-sectional view of one embodiment of a disposable housing assembly obtained in "B" as shown in Figure 143A. [Figure 144A] Figure 144A is an isometric view of one embodiment of a disposable housing assembly. [Figure 144B] Figure 144B is an enlarged cross-sectional view of section "B" as shown in Figure 144A. [Figure 144C] Figure 144C is a top view of one embodiment of a disposable housing assembly. [Figure 144D]Figure 144D is an enlarged cross-sectional view of section "D" as shown in Figure 144C. [Figure 144E] Figure 144E is an explanatory diagram of a cross-section of a bubble trap according to one embodiment. [Figure 145] Figure 145 is a graph showing the volume delivered versus pump operating time for an embodiment of the pump system. [Figure 146] Figure 146 is a graph of one embodiment of the optical sensor output as a function of the reflector distance. [Figure 147] Figure 147 is an explanatory diagram illustrating various locations of the optical sensor in one embodiment of the injection pump assembly. [Figure 148] Figures 148A-148B show an embodiment of an optical sensor assembly, where 148B is an enlarged cross-sectional view following section "B" of Figure 148A. [Figure 149] Figures 149A-149B show an embodiment of an optical sensor assembly, where 149B is an enlarged cross-sectional view following section "B" of Figure 149A. [Figure 150] Figure 150 is a schematic diagram of one embodiment of the pump system. [Figure 151] Figure 151 is a schematic diagram of a pump plunger drive electronic device according to one embodiment. [Figure 152] Figure 152 is a graph of the pump plunger target position versus the delivered volume according to one embodiment. [Figure 153] Figure 153 is a schematic diagram of a pump plunger model as a gain element with a dead zone and saturation limit, according to one embodiment. [Figure 154A] Figure 154A is a schematic diagram of an SMA power controller according to one embodiment. [Figure 154B] Figure 154B is a graph of time versus pump plunger position according to one embodiment. [Figure 154C] Figure 154C is a graph of time versus duty cycle according to one embodiment. [Figure 155] Figure 155 is a schematic diagram of the sampling time. [Figure 156]Figure 156 is a graph of time versus pump plunger position according to one embodiment. [Figure 157] Figure 157 is a graph of time versus measurement valve position according to one embodiment. [Figure 158] Figure 158 shows a schematic SMA switch monitoring according to one embodiment. [Figure 159A] Figure 159A is a graph of the number of deliveries paired by position according to one embodiment. [Figure 159B] Figure 159B is a graph of the number of deliveries versus trajectory error according to one embodiment. [Figure 160] Figure 160 is a flowchart of a delivery controller according to one embodiment. [Figure 161] Figure 161 is a flowchart of an internal voltage and external volume feedback controller according to one embodiment. [Figure 162] Figure 162 is a flowchart of a volume controller structure according to one embodiment. [Figure 163] Figure 163 is a flowchart of one embodiment of feedforward for a volumetric delivery controller. [Figure 164] Figure 164 is a flowchart of one embodiment of a discontinuous leakage check. [Figure 165] Figure 165 is a flowchart of one embodiment of at least a part of the startup integrity test. [Figure 166] Figure 166 is a flowchart of one embodiment of at least a part of the startup integrity test. [Figure 167] Figure 167 is a flowchart of one embodiment of at least a part of the startup integrity test. [Figure 168] Figure 168 is a graph of the pump plunger target position versus the delivered volume according to one embodiment. [Figure 169] Figure 169 is a graph of valve position versus discharged volume according to one embodiment. [Figure 170] Figure 170 is a graph of the pump plunger target position versus the delivered volume according to one embodiment. [Figure 171] Figure 171 is a flowchart of a volume controller structure according to one embodiment. [Figure 172] Figure 172 is a flowchart of an internal voltage and external volume feedback controller according to one embodiment. [Figure 173] Figures 173A-173B show a reservoir membrane according to one embodiment. [Figure 174] Figures 174A-174D are cross-sectional views of a reservoir membrane according to one embodiment. [Figure 175] Figure 175 shows an actuator assembly according to one embodiment. [Figure 176A] Figure 176A is a diagram of an actuator assembly according to one embodiment. [Figure 176B] Figure 176B shows an actuator assembly according to one embodiment. [Figure 177] Figures 177A and 177B show an actuator assembly according to one embodiment. [Figure 178] Figures 178A and 178B show an actuator assembly according to one embodiment. [Figure 179] Figures 179A and 179B show an actuator assembly according to one embodiment. [Figure 180] Figure 180 shows an actuator assembly according to one embodiment. [Figure 181] Figures 181-184 show various diagrams of different embodiments of the configuration of the measuring valve and the shape memory alloy structure. [Figure 182] Figures 181-184 show various diagrams of different embodiments of the configuration of the measuring valve and the shape memory alloy structure. [Figure 183] Figures 181-184 show various diagrams of different embodiments of the configuration of the measuring valve and the shape memory alloy structure. [Figure 184] Figures 181-184 show various diagrams of different embodiments of the configuration of the measuring valve and the shape memory alloy structure. [Figure 185A]Figures 185A and 185B show one embodiment of disposable packaging according to one embodiment. [Figure 185B] Figures 185A and 185B show one embodiment of disposable packaging according to one embodiment. [Figure 186A] Figures 186A and 186B show one embodiment of disposable packaging according to one embodiment. [Figure 186B] Figures 186A and 186B show one embodiment of disposable packaging according to one embodiment. [Figure 187A] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 187B] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 187C] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 187D] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 187E] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 187F] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 187G] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 187H] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 187I] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 187J] Figures 187A and 187J show one embodiment of disposable packaging according to one embodiment. [Figure 188] Figure 188 shows one embodiment of a two-pump system. [Figure 189A] Figure 189A is an explanatory diagram of a static state of one embodiment of the pump system. [Figure 189B] Figure 189B is an explanatory diagram of the filling state of one embodiment of the pump system. [Figure 189C] Figure 189C is an explanatory diagram of the delivery state in one embodiment of the pump system. [Figure 190] Figure 190 shows one embodiment of a disposable housing assembly having a Luer connector. [Figure 191] Figure 191 shows one embodiment of a locking ring on a disposable housing assembly. [Figure 192] Figure 192 shows one embodiment of a charger with charging pins. [Figure 193A] Figure 193A shows one embodiment of the pump assembly. [Figure 193B] Figure 193B shows an explanatory diagram of the embodiment shown in Figure 193A. [Figure 194] Figure 194 shows an explanatory diagram of one embodiment of a locking ring spring latch. [Figure 195] Figure 195 shows an explanatory diagram of one embodiment of a disposable detection system. [Figure 196] Figure 196 is an illustrative diagram of one embodiment of a system for determining the initial reservoir volume after filling. [Figure 197] Figure 197 is an illustrative diagram of one embodiment of the reservoir. [Figure 198] Figure 198 illustrates one embodiment of connecting pipes to a disposable housing assembly. [Figure 199] Figure 199 illustrates one embodiment of a pipe connector to a disposable housing assembly. [Figure 200] Figures 200A-200B illustrate one embodiment of a pipe connector to a disposable housing assembly. [Figure 201] Figures 201A-201B illustrate an example of a pipe connector to a disposable housing assembly. [Figure 202] Figure 202 illustrates one embodiment of a pipe connector to a disposable housing assembly. [Figure 203A]Figures 203A-203B illustrate an example of a pipe connector to a disposable housing assembly. [Figure 203B] Figures 203A-203B illustrate an example of a pipe connector to a disposable housing assembly. [Figure 204] Figures 204A-204C illustrate one embodiment of a pipe connector to a disposable housing assembly. [Figure 205] Figure 205 is an illustrative diagram of an embodiment of connecting pipes to a connector. [Figure 206] Figure 206 shows one embodiment of a connector attached to a pipe. [Figure 207] Figure 207 shows one embodiment of a connector attached to a tube, which is attached to a cannula. [Figure 208] Figure 208 shows one embodiment of a connector attached to a tube and attached to a cannula, and a disposable housing assembly, according to one embodiment. [Figure 209] Figure 209 is a diagram of one embodiment of the connector shown in Figures 206-208, which is connected to an embodiment of a disposable housing assembly. [Figure 210] Figure 210 is a diagram of one embodiment of the connector shown in Figures 206-208, which is connected to an embodiment of a disposable housing assembly. [Figure 211] Figures 211-217 illustrate various embodiments of the plug. [Figure 212] Figures 211-217 illustrate various embodiments of the plug. [Figure 213] Figures 211-217 illustrate various embodiments of the plug. [Figure 214] Figures 211-217 illustrate various embodiments of the plug. [Figure 215] Figures 211-217 illustrate various embodiments of the plug. [Figure 216] Figures 211-217 illustrate various embodiments of the plug. [Figure 217]Figures 211-217 illustrate various embodiments of the plug. [Figure 218A] Figures 218A-218C show various embodiments of the connector. [Figure 218B] Figures 218A-218C show various embodiments of the connector. [Figure 218C] Figures 218A-218C show various embodiments of the connector. [Figure 219A] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219B] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219C] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219D] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219E] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219F] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219G] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219H] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219I] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219J] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219K] Figures 219A and 219M are diagrams illustrating the various stages of a connector's interaction with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219L] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 219M] Figures 219A-219M illustrate embodiments of a connector at various stages, interacting with an embodiment of a disposable housing assembly so that the connector can be attached to the disposable housing assembly. [Figure 220A] Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 220B] Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 220C]Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 220D] Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 220E] Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 220F] Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 220G] Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 220H] Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 220I] Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 220J] Figures 220A-220J illustrate embodiments of a connector connected to a disposable housing assembly, and embodiments of a reusable housing assembly at various stages that are rotatably connected to a disposable housing assembly. [Figure 221]Figure 221 is a partial view of one embodiment of a disposable housing assembly. [Figure 222] Figure 222 is a partial view of one embodiment of a disposable housing assembly, including a finger cutout. [Figure 223A] Figure 223A is an exploded view of a swivel connector and a shut-off valve according to one embodiment. [Figure 223B] Figure 223B shows an assembled diagram of a swivel connector and a shut-off valve according to one embodiment. [Figure 224] Figure 224 shows a locking connector attached to a disposable housing assembly according to one embodiment. [Figure 225A] Figure 225A shows one embodiment of a peripheral connector attached to a disposable housing assembly, according to one embodiment. [Figure 225B] Figure 225B is an illustrative exploded view of a peripheral connector and disposable housing assembly according to one embodiment. [Figure 226] Figure 226 is an illustrative partial exploded view of a peripheral connector and disposable housing assembly according to one embodiment. [Figure 227] Figures 227A-227C show an assembly of one embodiment of a foldable snap connector, which is attached to one embodiment of a disposable housing assembly. [Figure 228A] Figure 228A is an exploded view of one embodiment of a peripheral connector and one embodiment of a disposable housing assembly. [Figure 228B] Figure 228B is a diagram of one embodiment of the peripheral connector shown in Figure 228A, which is attached to the disposable housing assembly shown in Figure 228A. [Figure 229] Figure 229 shows one embodiment of a connector attached to an embodiment of a disposable housing assembly. [Figure 230] Figure 230 shows one embodiment of a connector attached to an embodiment of a disposable housing assembly. [Figure 231A]Figures 231A-231D show various embodiments of a clamping connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 231B] Figures 231A-231D show various embodiments of a clamping connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 231C] Figures 231A-231D show various embodiments of a clamping connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 231D] Figures 231A-231D show various embodiments of a clamping connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 231E] Figure 231E is a cross-sectional view of one embodiment of a clamping connector connected to an embodiment of a disposable housing assembly. [Figure 232A] Figures 232A-232D show various embodiments of a top and bottom connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 232B] Figures 232A-232D show various embodiments of a top and bottom connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 232C] Figures 232A-232D show various embodiments of a top and bottom connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 232D] Figures 232A-232D show various embodiments of a top and bottom connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 232E] Figure 232E is a cross-sectional view of one embodiment of the upper and lower connectors connected to an embodiment of a disposable housing assembly. [Figure 233A] Figures 233A-233F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 233B] Figures 233A-233F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 233C] Figures 233A-233F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 233D] Figures 233A-233F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 233E] Figures 233A-233F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 233F] Figures 233A-233F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 233G] Figure 233G is a cross-sectional view of one embodiment of a connector connected to an embodiment of a disposable housing assembly. [Figure 234A] Figures 234A-234F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 234B] Figures 234A-234F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 234C] Figures 234A-234F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 234D] Figures 234A-234F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 234E] Figures 234A-234F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 234F] Figures 234A-234F show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 234G]FIG. 234G is a cross-sectional view of one embodiment of a connector connected to an embodiment of a disposable housing assembly. [Figure 235A] FIGS. 235A - 235C are views of an embodiment of a connector. [Figure 235B] FIGS. 235A - 235C are views of an embodiment of a connector. [Figure 235C] FIGS. 235A - 235C are views of an embodiment of a connector. [Figure 235D] FIG. 235D is a view of an embodiment of a disposable housing assembly. [Figure 235E] FIG. 235E is a cross-sectional view of cross-section "A" from FIG. 235D. [Figure 236A] FIGS. 236A - 236H are various views of an embodiment of a connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 236B] FIGS. 236A - 236H are various views of an embodiment of a connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 236C] FIGS. 236A - 236H are various views of an embodiment of a connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 236D] FIGS. 236A - 236H are various views of an embodiment of a connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 236E] FIGS. 236A - 236H are various views of an embodiment of a connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 236F] FIGS. 236A - 236H are various views of an embodiment of a connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 236G] FIGS. 236A - 236H are various views of an embodiment of a connector, a tubing set, and a disposable housing assembly according to one embodiment. [Figure 236H]Figures 236A-236H show various embodiments of a connector, tubing set, and disposable housing assembly according to one embodiment. [Figure 236I] Figures 236I-236K show various embodiments of the connector. [Figure 236J] Figures 236I-236K show various embodiments of the connector. [Figure 236K] Figures 236I-236K show various embodiments of the connector. [Figure 236L] Figure 236L is a cross-sectional view of a connector connected to a disposable housing assembly according to one embodiment. [Figure 236M] Figures 236M-236P show various diagrams of a connector connected to a disposable housing assembly according to one embodiment. [Figure 236N] Figures 236M-236P show various diagrams of a connector connected to a disposable housing assembly according to one embodiment. [Figure 236O] Figures 236M-236P show various diagrams of a connector connected to a disposable housing assembly according to one embodiment. [Figure 236P] Figures 236M-236P show various diagrams of a connector connected to a disposable housing assembly according to one embodiment. [Figure 236Q] Figures 236Q-236R illustrate a connector partially connected to a disposable housing assembly according to one embodiment. [Figure 236R] Figures 236Q-236R illustrate a connector partially connected to a disposable housing assembly according to one embodiment. [Figure 236S] Figures 236S-236T show a connector connected to a disposable housing assembly according to one embodiment. [Figure 236T] Figures 236S-236T show a connector connected to a disposable housing assembly according to one embodiment. [Figure 237] Figure 237 is a bottom view of one embodiment of a connector connected to one embodiment of a disposable housing assembly, the connector including an RFID tag. [Figure 238] FIG. 238 is an exploded view of an embodiment of a disposable housing assembly and embodiments of a connector, tubing, and cannula assembly. [Figure 239] FIG. 239 is a cross-sectional view of a certain cross-section of a reusable housing assembly connected to a disposable housing assembly, according to one embodiment. [Figure 240] FIG. 240 is an exploded view of an embodiment of a volume measurement sensor. [Figure 241] FIGS. 241A and 241B are views of an actuator assembly, according to one embodiment. [Figure 242] FIGS. 242 and 243 are views of a measurement valve assembly, according to one embodiment. [Figure 243] FIGS. 242 and 243 are views of a measurement valve assembly, according to one embodiment. [Figure 244A] FIG. 244A is a top view of an embodiment of a disposable housing assembly. [Figure 244B] FIG. 244B is a cross-sectional view of an embodiment of a disposable housing assembly taken from cross-section "B" shown in FIG. 244A. [Figure 245A] FIG. 245A is a partial cross-sectional view of a disposable housing assembly, according to one embodiment. [Figure 245B] FIG. 245B is a partial cross-sectional view of an embodiment in which a disposable housing assembly and a reusable housing assembly are engaged. [Figure 246A] FIG. 246A is a view of the inside of a reusable housing assembly cover, according to one embodiment. [Figure 246B] FIG. 246B is a cross-sectional view of cross-section "A" of FIG. 246A. [Figure 247A] FIGS. 247A - 247C are various views of an embodiment of a clip assembly. [Figure 247B] FIGS. 247A - 247C are various views of an embodiment of a clip assembly. [Figure 247C] FIGS. 247A - 247C are various views of an embodiment of a clip assembly. [Figure 248] Figure 248 is a bottom view of one embodiment of the housing of the clip assembly. [Figure 249A] Figures 249A-249D are various diagrams of one embodiment of the clip portion. [Figure 249B] Figures 249A-249D are various diagrams of one embodiment of the clip portion. [Figure 249C] Figures 249A-249D are various diagrams of one embodiment of the clip portion. [Figure 249D] Figures 249A-249D are various diagrams of one embodiment of the clip portion. [Figure 250] Figure 250 shows one embodiment of a disposable housing assembly. [Figure 251] Figure 251 is a detailed cross-sectional view of a disposable housing assembly shown in Figure 250. [Figure 252] Figure 252 shows one embodiment of a disposable housing assembly. [Figure 253] Figure 253 is a cross-sectional view of section "B" shown in Figure 252. [Figure 254] Figure 254 shows one embodiment of a disposable housing assembly. [Figure 255] Figure 255 is a detailed cross-sectional view of a disposable housing assembly shown in Figure 254. [Figure 256A] Figures 256A-256C show various embodiments of the plug. [Figure 256B] Figures 256A-256C show various embodiments of the plug. [Figure 256C] Figures 256A-256C show various embodiments of the plug. [Figure 256D] Figure 256D is a partial view of one embodiment of the exit of a disposable housing assembly. [Figure 257A] Figure 257A is a diagram of one embodiment of the connector. [Figure 257B] Figure 257B is a cross-sectional view of one embodiment of the plug shown in Figure 257A. [Figure 258A]Figure 258A is a diagram of one embodiment of the connector. [Figure 258B] Figure 258B is a cross-sectional view of one embodiment of the plug shown in Figure 258A. [Figure 259A] Figure 259A is a diagram of one embodiment of the connector. [Figure 259B] Figure 258B is a cross-sectional view of one embodiment of the plug shown in Figure 259A. [Figure 259C] Figure 259C is a partial view of one embodiment of the connector. [Figure 260A] Figures 260A-260G are various diagrams of one embodiment of the connector. [Figure 260B] Figures 260A-260G are various diagrams of one embodiment of the connector. [Figure 260C] Figures 260A-260G are various diagrams of one embodiment of the connector. [Figure 260D] Figures 260A-260G are various diagrams of one embodiment of the connector. [Figure 260E] Figures 260A-260G are various diagrams of one embodiment of the connector. [Figure 260F] Figures 260A-260G are various diagrams of one embodiment of the connector. [Figure 260G] Figures 260A-260G are various diagrams of one embodiment of the connector. [Figure 261A] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 261B] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 261C] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 261D] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 261E] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 261F] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 261G] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 261H] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 261I] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 261J] Figures 261A and 262K are various diagrams of one embodiment of the connector. [Figure 262A] No explanation provided. [Figure 262B] No explanation provided. [Figure 262C] No explanation provided. [Figure 262D] No explanation provided. [Figure 262E] No explanation provided. [Figure 262F] No explanation provided. [Figure 262G] No explanation provided. [Figure 262H] No explanation provided. [Figure 262I] No explanation provided. [Figure 262J] No explanation provided. [Figure 262K] No explanation provided. [Figure 263A] Figures 263A and 263I show various diagrams of one embodiment of a connector along with one embodiment of a disposable housing assembly. [Figure 263B] Figures 263A and 263I show various diagrams of one embodiment of a connector along with one embodiment of a disposable housing assembly. [Figure 263C] Figures 263A and 263I show various diagrams of one embodiment of a connector along with one embodiment of a disposable housing assembly. [Figure 263D] Figures 263A and 263I show various diagrams of one embodiment of a connector along with one embodiment of a disposable housing assembly. [Figure 263E] Figures 263A and 263I show various diagrams of one embodiment of a connector along with one embodiment of a disposable housing assembly. [Figure 263F]Figures 263A and 263I show various diagrams of one embodiment of a connector along with one embodiment of a disposable housing assembly. [Figure 263G] Figures 263A and 263I show various diagrams of one embodiment of a connector along with one embodiment of a disposable housing assembly. [Figure 263H] Figures 263A and 263I show various diagrams of one embodiment of a connector along with one embodiment of a disposable housing assembly. [Figure 263I] Figures 263A and 263I show various diagrams of one embodiment of a connector along with one embodiment of a disposable housing assembly. [Figure 264A] Figures 264A and 264B show various embodiments of the clip assembly. [Figure 264B] Figures 264A and 264B show various embodiments of the clip assembly. [Figure 265] Figure 265 is an exploded view of one embodiment of a clip assembly. [Modes for carrying out the invention]

[0019] Similar reference symbols in various drawings indicate similar elements.

[0020] Referring to Figure 1-3, the injection pump assembly 100 may include a reusable housing assembly 102. The reusable housing assembly 102 may be constructed from any suitable material, such as rigid or stiff plastic, which will resist compression. For example, the use of durable materials and components may improve quality and reduce costs by providing a longer-lasting, more durable reusable part and better protection for the components placed therein.

[0021] The reusable housing assembly 102 may include a mechanical control assembly 104 having a pump assembly 106 and at least one valve assembly 108. The reusable housing assembly 102 may also include an electrical control assembly 110 configured to provide one or more control signals to the mechanical control assembly 104 and to achieve the basis and / or bolus delivery of injectable fluid to the user. The disposable housing assembly 114 may include a valve assembly 108 which 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 which may be configured to deliver injectable fluid from the fluid path to the user.

[0022] The electrical control assembly 110 may monitor and control the amount of injectable fluid that has been and / or is being dispensed. For example, the electrical control assembly 110 may receive a signal from the volume sensor assembly 148, calculate the amount of injectable fluid that has just been dispensed, and determine whether a sufficient amount of injectable fluid has been dispensed based on the dose required by the user. If a sufficient amount of injectable fluid has not been dispensed, the electrical control assembly 110 may determine that more injectable fluid should be dispensed. The electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that any additional required dose may be dispensed, or the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that any additional dose may be dispensed along with the next dose. Alternatively, if an excess of injectable fluid has been dispensed, the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that a smaller amount of injectable fluid may be dispensed in the next dose.

[0023] The mechanical control assembly 104 may include at least one shape memory actuator 112. The pump assembly 106 and / or valve assembly 108 of the mechanical control assembly 104 may be actuated by at least one shape memory actuator, which may be a shape memory wire in the form of a wire or spring, the shape memory actuator 112. The shape memory actuator 112 may be operably connected to and activated by an electrical control assembly 110, which can control the timing and the amount of thermal and / or electrical energy used to actuate the mechanical control assembly 104. The shape memory actuator 112 may be, for example, a conductive shape memory alloy wire that changes shape with temperature. The temperature of the shape memory actuator 112 may be changed by a heater or, more conveniently, by the application of electrical energy. The shape memory actuator 112 is NITINOL TM Alternatively, it may be a shape memory wire constructed from a nickel / titanium alloy such as FLEXINOL®.

[0024] The injection pump assembly 100 may include a volume sensor assembly 148 configured to monitor the amount of fluid injected by the injection pump assembly 100. For example, the volume sensor assembly 148 may employ, for example, acoustic volume sensing. Acoustic volume measurement techniques are the subject of U.S. Patent Nos. 5,575,310 and 5,755,683, assigned to DEKA Products Limited Partnership, and U.S. Patent Publications US2007 / 0228071A1, US2007 / 0219496A1, 2007 / 0219480A1, and U.S.2007 / 0219597A1, which are incorporated herein by reference in their entirety. Other alternative techniques for measuring flow rate may also be used, such as Doppler-based methods, the use of Hall effect sensors combined with vane or flapper valves, the use of strain beams (e.g., associated with a flexible member covering a fluid reservoir to sense the deflection of a flexible member), the use of volume sensing with plates, or the thermal time-of-flight method. One such alternative technique is disclosed in U.S. Patent Application No. 11 / 704,899 (Agent Reference Number E70), titled Fluid Delivery Systems and Methods, filed on 9 February 2007 and published on 4 October 2007 in U.S. Patent Publication No. US-2997-0228071-A1, which is incorporated herein by reference in its entirety. The injection pump assembly 100 may be configured such that the volume measurement produced by the volume sensor assembly 148 can be used to control the amount of injectable fluid injected to the user through a feedback loop.

[0025] The injection pump assembly 100 may further include a disposable housing assembly 114. For example, the disposable housing assembly 114 may be configured for single use or for use for a specified period, such as three days or any other amount of time. The disposable housing assembly 114 may be configured such that any components in the injection pump assembly 100 that come into contact with the injectable fluid are located on and / or inside the disposable housing assembly 114. For example, a fluid path or channel including a reservoir may be located within the disposable housing assembly 114 and may be configured for single use or for a specified number of uses before disposal. The disposable nature of the disposable housing assembly 114 can improve the hygiene of the injection pump assembly 100.

[0026] See also Figure 4, the disposable housing assembly 114 may be configured to releasably engage with the reusable housing assembly 102 and include a cavity 116 having a reservoir 118 for receiving an injectable fluid (not shown), such as insulin. Such a releasable engagement may be achieved, for example, by a screw, twist-lock, or compression-fit configuration. The disposable housing assembly 114 and / or the reusable housing assembly 102 may include a matching assembly configured to assist in matching the disposable housing assembly 114 and the reusable housing assembly 102 for engagement in a particular orientation. Similarly, a base ridge 120 and an upper ridge 122 may be used as indicators of matching and complete engagement.

[0027] The cavity 116 may be at least partially formed by and 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 the base portion 128 of the disposable housing assembly 114. For example, the membrane assembly 124 may be positioned 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 adhesive, heat fusion, and / or compression fitting, such that a seal 130 is formed between the membrane assembly 124 and the base portion 128. The membrane assembly 124 may be flexible, and the space formed between the membrane assembly 124 and the recess 126 in the base portion 128 may define the reservoir 118. The reservoir 118 is non-pressurized and may be in fluid communication with a fluid path (not shown). The membrane assembly 124 may be at least partially collapsible, and the cavity 116 may include a discharge assembly, thereby advantageously preventing the accumulation of vacuum in the reservoir 118 as the injectable fluid is delivered from the reservoir 118 to the fluid path. In a preferred embodiment, the membrane assembly 124 is fully collapsible and therefore allows for complete delivery of the injectable fluid. The cavity 116 may be configured to provide sufficient space to ensure that there is always some void even when the reservoir 118 is filled with the injectable fluid.

[0028] The membranes and reservoirs described herein may be made from 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 for functioning as described herein. In addition, other structures can serve the same purpose.

[0029] The use of a partially collapsible, non-pressurized reservoir can advantageously prevent the accumulation of air in the reservoir when the fluid in the reservoir is depleted. The accumulation of air in a reservoir with a vent can prevent fluid leakage from the reservoir, particularly when the system is tilted such that an air pocket is interposed between the fluid contained in the reservoir and the reservoir's partition. System tilting is expected during normal operation as a wearable device.

[0030] The reservoir 118 may be conveniently sized to carry a sufficient supply of insulin for delivery over one day or more. For example, the reservoir 118 may carry about 1.00 ml to 3.00 ml of insulin. A 3.00 ml insulin reservoir may correspond to a supply of about 3 days for about 90% of potential users. In other embodiments, the 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 the cavity 116 and reservoir 118 relate to the type of injectable fluid to which the cavity 116 and reservoir 118 are adapted to carry.

[0031] The disposable housing assembly 114 may include a support member 132 (Figure 3) configured to prevent accidental compression of the reservoir 118. Compression of the reservoir 118 could force an unintentional amount of injectable fluid onto the user through the fluid pathway. In preferred embodiments, the reusable housing assembly 102 and the disposable housing assembly 114 may be constructed of a rigid material that is not easily compressible. However, as an additional precaution, the support member 132 may be included in the disposable housing assembly 114 to prevent compression of the injection pump assembly 100 and the cavity 116 within it. The support member 132 may be a rigid projection from the base portion 128. For example, the support member 132 may be located within the cavity 116 to prevent compression of the reservoir 118.

[0032] As discussed above, the cavity 116 may be configured to provide sufficient space to ensure that there is always some void even when the reservoir 118 is filled with injectable fluid. Thus, if the injection pump assembly 100 is accidentally compressed, the injectable fluid does not need to be pushed through the cannula assembly 136 (for example, shown in Figure 9).

[0033] The cavity 116 may include a partition assembly 146 (Figure 3) configured to allow the reservoir 118 to be filled with an injectable fluid. The partition assembly 146 may be a conventional partition made of rubber or plastic and may have a one-way fluid valve configured to allow the user to fill the reservoir 118 with a syringe or other filling device. In some embodiments, the partition 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 Figure 3) for supporting the area around the lower surface of the partition so as to maintain the integrity of the partition seal when a needle is introducing the injectable fluid into the cavity 116. The support structure may be configured to support the partition while still allowing the introduction of a needle for introducing the injectable fluid into the cavity 116.

[0034] See also Figures 134A-135B, which show embodiments of the upper portion 2962 of the disposable housing assembly. The upper portion 2962 is shown in Figure 134A, and a cross-sectional view obtained in "B" is shown in Figure 134B. The partition assembly 2964 is shown. In some embodiments, the partition assembly 2964 includes a tunnel feature that, in some embodiments, can function as a feature for pressing a needle (e.g., a filling needle) without directly pressing full force onto the partition 2966. In some embodiments, as shown in Figures 134A-134C, the partition 2966 may be a separately molded part that is attached to the disposable housing assembly portion 2962 but separate from the membrane assembly 902.

[0035] Referring now to Figures 135A-135B, which show 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 molded into the membrane assembly 902.

[0036] In some embodiments of the various embodiments of the partition assemblies 2964 and 2968, the partitions 2970 and 2976 may be at a 45-degree angle to the upper portion 2962. In some embodiments, the partitions 2970 and 2976 may be made from the same material as the membrane assembly 902.

[0037] The injection pump assembly 100 may include, for example, an overfill prevention assembly (not shown) that can protrude into the cavity 116 and prevent overfilling of the reservoir 118.

[0038] In some embodiments, the reservoir 118 may be configured to be refilled multiple times. For example, the reservoir 118 may be refillable through the partition assembly 146. As the injectable fluid is dispensed to the user, the electronic control assembly 110 may monitor the liquid level of the injectable fluid in the reservoir 118. When the liquid level reaches a low point, the electronic control assembly 110 may provide the user with a signal, such as light or vibration, indicating that the reservoir 118 needs to be refilled. A syringe or other filling device may be used to fill the reservoir 118 through the partition 146.

[0039] The reservoir 118 may be configured to be filled in a single step. For example, a refill prevention assembly (not shown) may be used 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 or electromechanical device. For example, insertion of a syringe into the partition assembly 146 to fill the reservoir 118 may trigger a shutter to cover and close the partition 146 after the single fill, thus preventing further access to the partition 146. Similarly, a sensor may indicate to the electronic control assembly 110 that the reservoir 118 has been filled once, and after the single fill, a shutter may be triggered to cover and close the partition 146, thus preventing further access to the partition 146. Other means of preventing refilling may be used and are considered to be within the scope of this disclosure.

[0040] As discussed above, the disposable housing assembly 114 may include a partition assembly 146 that can be configured to allow the reservoir 118 to be filled with a fluid that can be entered. The partition assembly 146 may be a conventional partition made of rubber or any other material that can function as a partition, or in other embodiments, the partition assembly 146 may be, but is not limited to, a one-way fluid valve made of plastic or other material. In various embodiments, including exemplary embodiments, the partition assembly 146 is configured to allow a user to fill the reservoir 118 from a syringe or other filling device. The disposable housing assembly 114 may include a partition access assembly that can be configured to limit the number of times a user can refill the reservoir 118.

[0041] For example, also referring to Figures 5A-5C, the bulkhead access assembly 152 may include a shutter assembly 154, which can be supported in an "open" position by a tab assembly 156 configured to fit into a slot assembly 158. When the filling syringe 160 penetrates the bulkhead 146, the shutter assembly 154 may be positioned downward, disengaging the tab assembly 156 from the slot assembly 158. Once disengaged, the spring assembly 162 may displace the shutter assembly 154 in the direction of arrow 164, so that the bulkhead 146 is no longer accessible to the user.

[0042] See also Figure 6A, which shows the bulkhead access assembly 166 of an alternative embodiment in the “open” position. Similar to the bulkhead access assembly 152, the bulkhead access assembly 166 includes a shutter assembly 168 and a spring assembly 170.

[0043] See also Figure 6B, an alternative embodiment of the bulkhead access assembly 172 is shown in an "open" position in which the tab 178 can engage with the slot 180. Similar to the bulkhead access assembly 166, the bulkhead access assembly 172 may include a shutter assembly 174 and a spring assembly 176. When the shutter assembly 172 is moved to a "closed" position (which may prevent further access to the bulkhead 146 by a user, for example), the tab 178 may engage with the slot 180a at least partially. The engagement between the tab 178 and the slot 180a may lock the shutter assembly 172 in the "closed" position to prevent tampering with or re-opening of the shutter assembly 172. The spring tab 182 of the shutter assembly 172 may bias the tab 178 to engage with the slot 180a.

[0044] However, in various embodiments, the partition access assembly does not have to be actuated linearly. For example, referring also to Figures 7A-7B, an alternative embodiment of the partition access assembly 184 is shown, which includes a shutter assembly 186 configured to pivot around an axis 188. When positioned in the open position (as shown in Figure 7A), the partition 146 may be accessible by a passage 190 (in the shutter assembly 186) that aligns with, for example, a passage 192 in the surface of the disposable housing assembly 114. However, as with the partition access assemblies 166, 172, when the partition 146 is penetrated by a filling syringe 160 (see Figure 6B), the shutter assembly 186 may be displaced clockwise, causing the passage 190 (in the shutter assembly 186) to no longer align with, for example, the passage 192 in the surface of the disposable housing assembly 114, and thus preventing access to the partition 146.

[0045] See also Figures 8A-8B, which show a partition access assembly 194 of an alternative embodiment. Similar to partition access assemblies 166 and 172, partition access assembly 194 includes a shutter assembly 196 and a spring assembly 198 configured to bias the shutter assembly 196 in the direction of arrow 200. A filling assembly 202 may be used to fill the reservoir 118. The filling assembly 202 may include a shutter displacement assembly 204, which can be configured to displace the shutter assembly 196 in the direction of arrow 206, thereby aligning the passage 208 in the shutter assembly 196 with the passage 210 in the partition 146 and partition access assembly 194, and thus allowing the filling syringe assembly 212 to penetrate the partition 146 and the filling reservoir 118.

[0046] The injection pump assembly 100 may include a sealing assembly 150 (Figure 3) configured to provide a seal between a reusable housing assembly 102 and a disposable housing assembly 114. For example, when the reusable housing assembly 102 and the disposable housing assembly 114 are engaged, for example, by a rotary screw engagement, a twist-lock engagement, or a compression engagement, the reusable housing assembly 102 and the disposable housing assembly 114 may fit together tightly and thus form a seal. In some embodiments, a more secure seal may be desirable. Therefore, the sealing assembly 150 may include an O-ring assembly (not shown). Alternatively, the sealing assembly 150 may include an overmolded seal assembly (not shown). The use of an O-ring assembly or an overmolded seal assembly can make the seal more secure by providing a compressible rubber or plastic layer between the reusable housing assembly 102 and the disposable housing assembly 114 when engaged, and thus preventing penetration by external fluid. In some cases, the O-ring assembly can prevent accidental engagement and disengagement. For example, the sealed assembly 150 may be a watertight assembly, thus allowing the user to wear the injection pump assembly 100 while swimming, bathing, or exercising.

[0047] See also Figure 9, the injection pump assembly 100 may include an external injection set 134 configured to deliver an injectable fluid to the user. The external injection set 134 may be in fluid communication with the cavity 118, for example, via a fluid path. The external injection set 134 may be located adjacent to the injection pump assembly 100. Alternatively, the external injection set 134 may be configured for remote application from the injection pump assembly 100, as will be discussed in more detail below. The external injection set 134 may include a cannula assembly 136, which may include a needle or disposable cannula 138, and a tubing assembly 140. The tubing assembly 140 may be in fluid communication with the reservoir 118, for example, via a fluid path, and with the cannula assembly 138, for example, either directly or through a cannula interface 142.

[0048] The external infusion set 134 may be a tethered infusion set, as discussed above with respect to remote application from the infusion pump assembly 100. For example, the external infusion set 134 may be in fluid communication with the infusion pump assembly 100 through a tubing assembly 140, which may be of any length desired by the user (e.g., 3 to 18 inches). The infusion pump assembly 100 may be attached to the user's skin by the use of an adhesive patch 144, but the length of the tubing assembly 140 may alternatively allow the user to attach the infusion pump assembly 100 in a pocket. This may be beneficial for users whose skin is easily irritated by the application of the adhesive patch 144. Similarly, attaching and / or securing the infusion pump assembly 100 in a pocket may be preferred for users engaged in physical activity.

[0049] In addition to / as an alternative to the adhesive patch 144, a hook-and-loop system (e.g., a hook-and-loop system provided by Velcro® USA Inc. (Manchester, NH)) may be used to enable easy attachment / removal of the injection pump assembly (e.g., injection pump assembly 100) to / from the user. Therefore, the adhesive patch 144 may be attached to the user's skin and may include an outward-facing hook or loop surface. In addition, the underside of the disposable housing assembly 114 may include a complementary hook or loop surface. Depending on the separation resistance of the particular type of hook-and-loop system employed, it is possible that the strength of the hook and loop connection may be stronger than the strength of the adhesive to the skin connection. Therefore, various hook and loop surface patterns may be used to adjust the strength of the hook and loop connection.

[0050] See also Figures 10A–10E, which illustrate five embodiments of such hook and loop surface patterns. For illustrative purposes, assume that the entire underside of a disposable housing assembly 114 is covered with the “loop” material. Thus, the strength of the hook and loop connection may be adjusted by varying the pattern (i.e., amount) of the “hook” material present on the surface of the adhesive patch 144. Embodiments of such patterns may include, but are not limited to, a single outer circle 220 of the “hook” material (as shown in Figure 10A), multiple concentric circles 222, 224 of the “hook” material (as shown in Figure 10B), multiple radial spokes 226 of the “hook” material (as shown in Figure 10C), multiple radial spokes 228 of the “hook material” combined with a single outer circle 230 of the “hook” material (as shown in Figure 10D), and multiple radial spokes 232 of the “hook” material combined with multiple concentric circles 234, 236 of the “hook” material (as shown in Figure 10E).

[0051] In addition, referring to Figure 11A, in one exemplary embodiment of the injection pump assembly described above, the injection pump assembly 100' may be configured via a remote control assembly 300. In this particular embodiment, the injection pump assembly 100' may include a telemetry circuit (not shown) that enables communication (e.g., wired or wireless) between the injection pump assembly 100' and, for example, the remote control assembly 300, and thus enables the remote control assembly 300 to remotely control the injection pump assembly 100'. The remote control assembly 300 (which may also include a telemetry circuit (not shown) and may be capable of communicating with the injection pump assembly 100') may include a display assembly 302 and an input assembly 304. The input assembly 304 may include a slider assembly 306 and switch assemblies 308, 310. In other embodiments, the input assembly may include a jog wheel, a plurality of switch assemblies, or equivalent.

[0052] The remote control assembly 300 may include the ability to pre-program base rates, bolus alarms, and delivery limits, and may allow the user to view history and establish user preferences. The remote control assembly 300 may also include a glucose strip reader.

[0053] During use, the remote control assembly 300 may provide commands to the injection pump assembly 100' via a wireless communication channel 312 established between the remote control assembly 300 and the injection pump assembly 100'. Therefore, the user may use the remote control assembly 300 to program / configure the injection pump assembly 100'. Some or all of the communication between the remote control assembly 300 and the injection pump assembly 100' may be encrypted to provide an enhanced level of security.

[0054] Communication between the remote control assembly 300 and the injection pump assembly 100' may be achieved using a standard communication protocol. Furthermore, communication between the various components contained within the injection pump assemblies 100 and 100' may be achieved using the same protocol. One embodiment of such a communication protocol is the Packet Communication Gateway Protocol (PCGP), developed by DEKA Research & Development (Manchester, NH). As discussed above, the injection pump assemblies 100, 100' may include an electrical control assembly 110 which may include one or more electrical components. For example, the electrical control assembly 110 may include a plurality of data processors (e.g., a supervisor processor and a command processor) and a wireless processor to enable the injection pump assemblies 100, 100' to communicate with the remote control assembly 300. Furthermore, the remote control assembly 300 may include one or more electrical components, and its embodiments 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 injection pump assemblies 100, 100'. A high-level diagram of one embodiment of such a system is shown in Figure 11B.

[0055] Each of these electrical components may be manufactured by a different component supplier and therefore may utilize its own (i.e., unique) communication commands. Thus, efficient communication between such heterogeneous components may be achieved through the use of standard communication protocols.

[0056] PCGP may be a flexible, extensible software module that can be used on the processors in the injection pump assemblies 100, 100' and the 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 adaptive interfaces to various drivers. For illustrative purposes only, PCGP may have the conceptual structure shown in Figure 11C for a given processor.

[0057] PCGP can ensure data integrity by utilizing periodic redundancy checks (CRC). PCGP can also provide guaranteed delivery status. For example, every new message should have a reply. If such a reply is not sent back in time, the message may time out, and PCGP may generate a negative response reply message (i.e., NACK) to the application. Thus, the message reply protocol may inform the application whether it should retry sending the message.

[0058] PCGP may also limit the number of in-flight messages from a given node, be coupled with a traffic control mechanism at the driver level to provide a deterministic approach to message delivery, and allow individual nodes to have different amounts of buffers without dropping packets. When a node runs out of buffers, the driver may provide back pressure to other nodes to prevent them from sending new messages.

[0059] PCGP may use a shared buffer pool scheme to minimize data copying and may avoid mutual exclusion, which may have a slight impact on the APIs used to send / receive messages to / from applications and a more significant impact on drivers. PCGP may use a “bridge” base class that provides routing and buffer ownership. Major PCGP classes may be subdivided from the bridge base class. Drivers may derive from bridge classes, communicate with derived bridge classes, or own them.

[0060] 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 it can operate on multiple threads. Figure 11D illustrates one such implementation. PCGP may operate identically in both environments, but there may be versions of the calls for a specific processor type (e.g., ARM9 / OS version). Thus, while the functionality may be identical, there may be an operating system abstraction layer with slightly different calls tailored to, for example, an ARM9 Nucleus OS environment. Referring also to Figure 11E, PCGP may do the following: • Enables multiple send / reply calls (on Pilot's ARM9 on multiple reentrant tasks). • Has multiple drivers that operate asynchronously for RX and TX on different interfaces. • Provides packet ordering for sending / receiving, and a deterministic timeout for message transmission.

[0061] Each software object may request the buffer manager for the next buffer it will use, and then give that buffer to another object. Buffers may pass automatically from one exclusive owner to another, and queues may arise automatically by ordering buffers by sequence number. When a buffer is no longer in use, it may be recycled (for example, an object may offer the buffer to itself or release it to the buffer manager for later reallocation). Thus, data generally does not need to be copied, and routing simply overwrites the buffer owner bytes. Such implementations of PCGP may offer various benefits, and examples of such implementations may include, but are not limited to, the following: - Once a message enters a buffer, it may remain there until it is forwarded or received by an application, making it impossible to drop the message due to the buffer running out. • Offsets are used to access the driver, PCGP, and buffer payload sections, so data does not need to be copied. The driver may change ownership of the message data by overwriting one byte (i.e., the buffer ownership byte). Mutual exclusion may only be necessary when a single buffer owner may want to use the buffer simultaneously or acquire a new sequence number; therefore, the need for multiple exclusions is not necessary except for reentrant calls. • There may be fewer rules for application writers to follow in order to implement a reliable system. Since there is a set of calls provided by the driver to push / pull data outside the buffer management system, the driver may use an ISR / push / pull / and polled data model. The driver does not need to perform copying, CRC, or any other checks, as destination bytes, CRC, and other checks can be performed later from the ISR hotpath, so the driver does not need to be very active except for TX and RX. Since the buffer manager can order accesses by sequence number, queue ordering may occur automatically. • Small code / variable footprint may be used, meaning the hot passcode can be small and overhead can be reduced.

[0062] As shown in Figure 11F, when a message needs to be sent, PCGP may quickly construct a packet and insert it into the buffer management system. Once inside the buffer management system, a call to "packetProcessor" may apply protocol rules and deliver the message to the driver / application. To send a new message or a reply, PCGP may do the following: For example, check the call arguments to ensure that the packet length is valid and the destination is correct. - Downlink allows PCGP to be used by the wireless processor to establish links, pairs, etc., and PCGP can notify the application when it is attempting to communicate over a non-functional link (instead of timing out), avoiding attempts to send messages over a downlink unless it is a wireless link. - Obtain the sequence number of a new message, or use the existing sequence number of an existing message. The packet is constructed, the payload data is copied and written to the CRC, and (from this point onward) the packet's integrity can be protected by the CRC. - Provide the message to the buffer manager as a reply or new message, and check if putting this buffer into the buffer manager exceeds the maximum number of outgoing messages in the waiting state.

[0063] See also Figures 11G-11H, PCGP may operate by having all the major work done in a single thread to avoid mutual exclusion and to avoid doing a lot of work on send / reply or driver calls. The "packetProcessor" call may need to apply protocol rules to reply, new send, and receive messages. Reply messages may simply be sent, while new and receive messages may have rules for sending the message. In each case, the software may loop as long as it is possible to apply protocol rules to the correct type of message until it can no longer process packets. Sending a new message may follow the rules below. Even just two messages can be considered authorized "in-flight" messages on the network. Sufficient data about the in-flight message may be stored to match the response and handle timeouts. Message reception may follow the rules below. • A matching response may remove the "in-flight" information slot, allowing a new packet to be sent. • Non-matching responses may be dropped. • New messages may be related to a protocol (for example, to retrieve / clear network statistics for this node). A buffer may be provided to the application to receive messages, and a callback may be used. The buffer may be released or it may remain owned by the application. Therefore, PCGP may be configured as follows: The recall function may copy the payload data out or use it completely before returning. The callback function may own the buffer and refer to the buffer's payload by the buffer and payload address, and the message may be processed later. The application may poll the PCGP system for received messages. The application may use a callback to set an event and then poll for incoming messages.

[0064] The communication system may have a limited number of buffers. When the PCGP runs out of buffers, the driver may stop receiving new packets, and the application may be told that the application cannot send new packets. To avoid this and maintain optimal performance, the application may attempt one or more steps, and embodiments thereof may include, but are not limited to, the following:

[0065] a) Applications should keep PCGP up-to-date wirelessly. Specifically, if the link is down and PCGP is unaware of it, PCGP may receive new messages to send and queue them (or not optimally time out messages), which can disrupt the send queue and delay applications from optimal link usage.

[0066] b) The application should periodically call "decrement timeout". Optimally, this should be every 20-100 milliseconds, unless the processor is sleeping. Generally, messages travel fast (a few milliseconds), slow (a few seconds), or not at all. The timeout is an attempt to remove "in-flight" messages that should be dropped to free up buffers and bandwidth. Not doing this often can delay when new messages are sent or when the application can queue new messages.

[0067] c) The application should ask the PCGP if there is any pending work to do before going to sleep. If there is nothing for the PCGP to do, the driver activity may wake the system, and therefore the PCGP will not need to make any calls to “packetProcessor” or “decrement timeout” until a new packet enters the system. Failure to do this may result in a timeout condition dropping messages that should have been sent / forwarded / received successfully.

[0068] d) Applications should not hold onto received messages indefinitely. The messaging system relies on prompt replies. If an application shares a PCGP buffer, holding onto a message means holding onto the PCGP buffer. A receiving node does not know if the sending node has timeouts configured for slow or fast wireless communication. This means that when a node receives a message, it should infer the network's fast timeout rate.

[0069] e) The application should call "packetProcessor" frequently. Calls may cause the application to send new messages that have been queued, or to handle the receipt of new messages. Calls may also cause buffer reallocation, and infrequent calls may cause delays in message traffic.

[0070] As shown in Figure 11I, at some point the RX driver may be prompted to receive a message from the other side of the interface. To ensure that the message is not dropped, the RX driver may ask the buffer manager if there is a buffer available to store the new message. The driver may then request a buffer pointer and begin filling the buffer with the received data. When a complete message is received, the RX driver may invoke a function to route the packet. The routing function may examine the destination byte in the packet header and change ownership to one of the other drivers or applications, or it may detect that the packet is bad and drop the packet by freeing the buffer. The PCGP RX overhead may consist of requesting the next available buffer and calling routing functions. An example of code that performs such functions is shown below. @Receive Request uint8 i=0, *p; if (Bridge::canReceiveFlowControl()) { p = Bridge::nextBufferRX(); while (not done) { p[i] = thenextbyte;} Bridge::route(p); } The driver may perform a TX by requesting a pointer to the next buffer to send from the buffer manager. The TX driver may then ask the other side of the interface whether it can receive the packet. If the other side rejects the packet, the TX driver does nothing to the buffer because its state has not changed. Otherwise, the driver may send the packet and recycle / release the buffer. An example of code that performs such a function is as follows: uint8 *p = Bridge::nextBufferTX(); if (p != (uint8 *)0) { Send the drug p; Bridge::recycle(p); } To avoid forwarding packets that exceed the maximum message system timeout period, the BufferManager::first(uint8 owner) function may be called, which can scan for buffers to free by requesting nextBuffer. Thus, a complete TX buffer that does not wish to time out may be freed on the thread that owns the buffer. A bridge performing a TX (i.e., searching for the next TX buffer) may free all TX buffers that would expire before receiving the next TX buffer for processing.

[0071] As shown in Figure 11J-11L, during the buffer allocation process, buffers marked as available may be forwarded to the driver to receive new packets or to the PCGP to receive new payloads for TX. Allocation from "available" may be performed by the "packetProcessor" function. The number of send and receive operations between "packetProcessor" calls may determine how many LT_Driver_RX, GT_Driver_RX, and PCGP_Free buffers need to be allocated. LT_Driver may represent a driver handling addresses less than the node address. GT_Driver may represent a driver handling addresses more than the node address.

[0072] When a driver receives a packet, it may place the data into an RX buffer which is then passed to the router. The router may then reallocate the buffer to PCGP_Receive or another driver's TX (not shown). If the buffer contains obviously invalid data, the buffer may transition to an available state.

[0073] After the router marks a buffer for TX, the driver may discover that the buffer is TX and send a message. After sending the message, if the driver is short on RX buffers, the buffer may immediately become an RX buffer, or the buffer may be freed for reallocation.

[0074] During the "packetProcessor" call, PCGP may process all buffers that the router has marked as PCGP_Receive. At this point, the CRC and other data items may be checked as the data may be affected. If the data is corrupted, the statistics may be incremented and the buffer may be released. Otherwise, the buffer may be marked as owned by the application. Buffers marked as owned by the application may be recycled for use by PCGP or released for reallocation by the buffer manager.

[0075] When an application wants to send a new message, it may be done in a reentrant, straightforward / mutual exclusion manner. If a buffer can be allocated, PCGP may mark the buffer as in use. Once marked as in use, it is owned by the invocation of the send or reply function call, and therefore no other thread calling this function should capture this buffer. The rest of the error checking and message construction process may be done outside of the isolated race condition mutual exclusion protection code. The buffer may transition to the available state, or become a valid, filled, CRC-checked buffer and be passed to the router. These buffers do not have to be routed immediately and may be queued so that they can be sent later (assuming protocol rules allow it). Reply messages may be routed with higher priority than regular outgoing messages, and there may be no rules limiting how many / when reply messages can be sent, so reply messages may be marked differently from new outgoing messages.

[0076] PCGP is designed to work in conjunction with flow control, and because there is no buffer on the other side of the interface (which can cause back pressure on the transmitting node), flow control may negotiate about the forwarding of messages from one node to another to ensure that the buffer is never dropped.

[0077] Flow control may be part of a shared buffer format. The first two bytes may be reserved for the driver so that the driver never needs to shift packet bytes. The two bytes may be used such that one byte is the DMA length minus 1 and the second byte controls the message flow. These identical two bytes may be synchronized if the PCGP message is transmitted over RS232.

[0078] When a packet is "in-flight," it may be in a process of being sent by a driver, processed by a destination, or returned as a response on its way to its destination.

[0079] Typical delays are as follows:

[0080] [Table 1]

[0081] Therefore, messages tend to complete their round trip either quickly (e.g., <50 milliseconds), slowly (e.g., 1 second or more), or never complete at all.

[0082] PCGP may use two different timeouts (set during initialization) for all timeouts, one for when the RF link is in fast heartbeat mode and the other for when the RF link is in slow mode. If a message is in flight and the link state changes from fast to slow, the timeout may be adjusted, and the difference between fast and slow may be added to the expiration counter for the packet. No additional transitions before or after may affect the expiration of the message.

[0083] There is a second timeout, which can be twice as long as the slow timeout, used to monitor buffer allocation within PCGP. Therefore, if a message is "stuck" in the driver and not sent, for example due to traffic control or hardware failure, the buffer may be released by the buffer manager, causing the buffer to drop. For "new" messages, this may mean that the packet has already timed out and the application has already received a reply indicating that the message was not delivered, and as a result the buffer is released. The buffer is released so that the driver has a message to send, as it polls the buffer manager for buffers that need to be sent, and the next time the obstacle is removed, the message is passed to the driver. For reply messages, the reply may simply be dropped, and the sending node may time out.

[0084] The PCGP messaging system may pass messages containing header information and payload. Outside of PCGP, the header may be a set of data items in a call signature. However, within PCGP, there may be a consistent driver-friendly byte layout. The driver may insert bytes either within or before the PCGP packet, as follows: • DE, CA: Synchronization bytes for use with RS232, nominal values ​​0xDE, 0xCA, or 0x5A, 0xA5. • LD: Driver DMA length bytes, the total size excluding size bytes or synchronization bytes, equal to the amount the driver is pushing in this DMA transfer. • Cmd: Driver commands and control bytes used for flow control. • LP: PCGP packet length, always equal to the total header + payload size in bytes + CRC size. LD = LP + 1. Dst: Destination address. • Src: Source address. • Cmd: Command byte. • Scd: Subcommand byte. • AT: Application tags are defined by the application and are not important to PCGP. This allows applications to attach further information to messages, such as the thread from which the message originated. • SeqNum: A 32-bit sequence number is incremented by PCGP for each new message sent, ensuring that the number is not rounded up, acts as a token, and is endianness-independent. • CRC16: 16-bit CRC for PCGP header and payload.

[0085] An example of a message with no payload and with 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, 0x1, crchigh, crclow. 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, and therefore, in this methodology, the driver and PCGP may share a buffer. A byte may be provided immediately after the DMA length to pass flow control information between drivers. Because the driver length and the "Cmd" byte may be outside the CRC area, they may be modified by the driver or owned by the driver transport mechanism, and the driver may take note of invalid lengths. There may be a separate PGCP packet length byte protected by CRC. Therefore, the application may trust that its payload length is correct. The endianness of a sequence number is merely a possible byte pattern that happens to be a 32-bit integer, and therefore does not need to be related. The sequence number may be four bytes aligned with the edges of the shared buffer pool length. There may be an optional RS232 synchronization byte to allow the user to move the cable around and resynchronize both sides of the interface while debugging the message stream. Applications, drivers, and PCGP may share buffers and free them by pointers.

[0086] PCGP does not have to be an event-driven software design, but may be used in an event-driven architecture depending on how the subclasses are written. Data may be exchanged conceptually between classes (as shown in Figures 11M-11N).

[0087] Some event models in the driver may involve starting the driver, receiving a message, or passing the message through a bridge to a buffer manager that sends the message to the new owner of the new message (through the driver or a bridge to PCGP).

[0088] The following summarizes some illustrative events.

[0089] [Table 2]

[0090] The following exemplary implementation demonstrates how a PCGP event model can work with Nucleus to initiate a PCGP task after a decTimeout has generated all sent messages, replies, or NACKs. class PcgpOS :public Pcgp { virtual void schedulePacketProcessor(void) {OS_EventGrp_Set(g_RCVEvGrps[EVG_RF_TASK]. pEvgHandle, RfRadioTxEvent, OS_EV_OR_NO_CLEAR); } } The following is an event-based pseudocode driver illustrating how driver events work. The driver subdivides the Bridge and disables hasMessagesToSend and flowControlTumedOff, planning to activate the TX and RX functions if they are not already operational. classSPI_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 voidTX_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); ESIRs(); } 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); ESIRs(); } } The following statistics may be supported by PCGP. • Number of packets sent · Number of packets received CRC error ·timeout • Unavailable buffer (buffer is gone) PCGP may be designed to operate in multiple processing environments. Most parameters may be runtime configured to facilitate testing and runtime fine-tuning of performance. Other parameters may be compile-time parameters, and may be anything that modifies, for example, memory allocations that must be performed statically at compile time. The following may also be a definition of the number of compile-time configurations that can vary where PCGP is implemented. • Driver bytes: These may be 2 bytes reserved for the common buffer scheme for the driver, but this may also be a compilation time option adapted to other drivers such as RF protocols. • Number of RX driver buffers: You may agree on how many buffers are preferable for that processor / traffic flow, etc. • PCGP RX buffer count: The number of buffers may be determined based on the processor / traffic flow, etc. • Total number of buffers: There may be agreement on how many buffers a processor should have.

[0091] A CRC may be used to ensure data integrity. If a CRC is invalid, it does not need to be delivered to the application, and CRC errors may be tracked. The message may eventually time out, or it may be retried by the sender.

[0092] Similarly, if the messaging system informs an application that a message was delivered when it was not, this can be dangerous for the system. A bolus stop command is an example of such a command. This may be mitigated by a message request / action sequence that may be required by the application to change the treatment method. The controller may receive a matching command from the pump application and review the delivered message.

[0093] DEKA may provide a reference method for interface connecting PCGP to a Nucleus OS system on ARM9 (as shown in Figure 11O).

[0094] As shown in Figure 11P, the pcgpOS.cpp file may create instances of PCGP node instances (Pcgp, Bridge, etc.) and may provide a set of C-linkable function calls through pcgpOS.h that provide a C language interface to C++ code. This may simplify the C code because the objects to be acted upon are implicit. The following general rules may apply. PCGP may operate on all nodes. Any driver may support a general driver interface. • Race conditions should not be allowed. Half-duplex support may be provided on the SPI port between the slave processor and the master processor. Since it either succeeds or fails / returns false, the data transfer may not even be attempted. • Low overhead (wasted time, processing, bandwidth) may be required. • The CC2510 operating at DMA (high-speed) SPI clock speeds may be supported.

[0095] If the receiving end does not currently have an empty buffer to place the packet in, SPI traffic control may prevent the data from being transmitted. This may be achieved by requesting permission to transmit and waiting for a response indicating that permission has been granted. Alternatively, there may be a way to inform the other party that there is no free buffer at the moment and that they should attempt the transmission later.

[0096] All transmissions may begin with a length byte indicating the number of bytes to be sent, which does not include the length byte itself. The length may be followed by a single byte indicating the command being sent.

[0097] The actual transmission of a packet may consist of the command byte, which may be the length of the packet plus one, followed by the command byte for any attached messages, and finally the packet itself.

[0098] In addition to the command bytes to be transmitted, an additional hardware line, referred to as a flow control line, may be added to the four conventional SPI signals. The purpose of this line is to allow the protocol to operate as quickly as possible without requiring a pre-configured delay. This also allows the slave processor to inform the master processor that there are packets waiting to be transmitted, thus eliminating the need for the master processor to poll the slave processor for status.

[0099] The following example command values ​​may be used.

[0100] [Table 3]

[0101] [Table 4]

[0102] As shown in Figure 11Q, when a slave processor has packets to send to the master processor, the slave processor may notify the master processor (by asserting a flow control line) that there are pending packets waiting to be sent. Doing so may result in an IRQ on the master processor, at which point the master processor may decide when to retrieve the message from the slave processor. Packet retrieval may be delayed at the discretion of the master processor, and the master processor may decide to attempt to send the packets to the slave processor before retrieving them from the slave processor.

[0103] The master processor may initiate retrieval by sending the slave processor the M_CTS command. This is repeated until the slave processor responds by sending the S_MSG_APPENDED command along with the packet itself. The flow control line may be released after the packet has been sent. If the M_CTS command is received by the slave processor unexpectedly, the M_CTS command may be ignored.

[0104] As illustrated in Figure 11R, when the master processor has a packet to send to the slave processor, the master processor may initiate the transfer by sending an M_RTS command. Upon receiving the M_RTS command, if the slave processor currently has any pending transmit packets, the slave processor will lower 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 SPI DMA to receive the packet, in which case the master processor may stop measuring byte time on the bus, allowing the slave processor to finish preparing to receive.

[0105] Next, the slave processor may indicate that it is ready to receive the entire packet by raising the flow control line (used as the CTS signal). Upon receiving the CTS signal, the master processor may then send the M_MSG_APPENDED command along with the packet itself.

[0106] After the transfer is complete, the slave processor may lower the flow control line. If the packet was pending at the start of the transfer, or if transmission occurred on the slave processor while the packet was being received, the slave processor may reassert the flow control line indicating that there is a pending packet.

[0107] Referring again to Figure 11A, the infusion pump assemblies 100, 100' may include a switch assembly 318 connected to an electrical control assembly 110 (Figure 3), which may enable a user (not shown) to perform at least one task, and in some embodiments, multiple tasks. One illustrative embodiment of such a task is the administration of a bolus dose of an injectable fluid (e.g., insulin) without using a display assembly. A remote control assembly 300 may enable / deactivate / configure the infusion pump assemblies 100, 100' to administer a bolus dose of insulin.

[0108] See also Figure 12A, the slider assembly 306 may be configured, at least in part, to allow the user to interact with menu-based information rendered on the display assembly 302. Embodiments of the slider assembly 306 may include a capacitive slider assembly that can be implemented using the CY8C21434-24LFXI PSOC provided by Cypress Semiconductor (San Jose, California), the design of which is described in the Cypress Semiconductor publication "CSD User Module". For example, via the slider assembly 306, the user may slide their finger in the direction of arrow 314 to bring up highlighted portions of information contained within the main menu 350 (shown in Figure 12A) rendered on the display assembly 302, which scrolls upward. Alternatively, the user may slide their finger in the direction of arrow 316 to bring up highlighted portions of information contained within the main menu 350 rendered on the display assembly 302, which scrolls downward.

[0109] The slider assembly 306 may be configured such that the speed at which the highlighted portion of the main menu 350 scrolls "up" or "down" varies depending on the displacement of the user's finger relative to the origin 320. Therefore, if the user desires to scroll "up" quickly, the user may position their finger near the top of the slider assembly 306. Similarly, if the user desires to scroll "down" quickly, the user may position their finger near the bottom of the slider assembly 306. In addition, if the user desires to scroll "up" slowly, the user may position their finger slightly "up" relative to the origin 320. Furthermore, if the user desires to scroll "down" slowly, the user may position their finger slightly "down" relative to the origin 320. When the appropriate menu item is highlighted, the user may select the highlighted menu item via one or more switch assemblies 308, 310.

[0110] See also Figures 12B-12F, for illustrative purposes, assume that the infusion pump assembly 100, 100' is an insulin pump, and the user desires to configure the infusion pump assembly 100, 100' such that a 0.20 unit bolus dose of insulin is administered when the switch assembly 318 is pressed by the user. Thus, the user may use the slider assembly 306 to highlight "Bolus" in 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) in the remote control assembly 300 may render a submenu 352 on the display assembly 302 (as shown in Figure 12B).

[0111] The user may then use the slider assembly 306 to highlight "Manual Bolus" in submenu 352, which can be selected using the switch assembly 308. The processing logic (not shown) in the remote control assembly 300 may then render submenu 354 on the display assembly 302 (as shown in Figure 12C).

[0112] The user may then use the slider assembly 306 to highlight "Bolus: 0.0 units" in the submenu 354, which can be selected using the switch assembly 308. The processing logic (not shown) in the remote control assembly 300 may then render the submenu 356 on the display assembly 302 (as shown in Figure 12D).

[0113] The user may then use the slider assembly 306 to adjust the bolus insulin amount to "0.20 units," which can be selected using the switch assembly 308. The processing logic (not shown) within the remote control assembly 300 may then render a submenu 358 on the display assembly 302 (as shown in Figure 12E).

[0114] Next, user 14 may use slider assembly 306 to highlight "Confirm," which can be selected using switch assembly 308. Then, processing logic (not shown) within remote control assembly 300 may generate appropriate signals that can be sent to the telemetry circuit (not shown) contained within remote control assembly 300. The telemetry circuit (not shown) contained within remote control assembly may then transmit appropriate configuration commands via wireless communication channel 312 established between remote control assembly 300 and infusion pump assembly 100' to configure infusion pump assembly 100' so that a 0.20 unit bolus dose of insulin is administered whenever switch assembly 318 is pressed by the user.

[0115] If the transmission of the appropriate command is successful, the processing logic (not shown) within the remote control assembly 300 may again render the submenu 350 on the display assembly 302 (as shown in Figure 12F).

[0116] Specifically, programmed via the remote control assembly 300, the user may press the switch assembly 318 of the infusion pump assembly 100' to administer a 0.20-unit bolus dose of the insulin described above. The user may define the amount of insulin administered each time the user presses the switch assembly 318 via the menu system contained within the remote control assembly 300. This particular embodiment specifies that one press of the switch assembly 318 is equivalent to 0.20 units of insulin, but other values ​​(e.g., 1.00 unit of insulin per press) are equally applicable, so this is for illustrative purposes only and is not intended to limit the disclosure.

[0117] For illustrative purposes, assume that the user desires to be administered a 2.00 unit bolus dose of insulin. To activate the above bolus dose delivery system, the user may be asked to press and hold the switch assembly 318 for a defined period (e.g., 5 seconds), at which point the infusion pump assembly 100, 100' may generate an audible signal to indicate to the user that the infusion pump assembly 100, 100' is ready to deliver a bolus dose of insulin via the switch assembly 318. Thus, the user may press the switch assembly 318 10 times (i.e., 2.00 units is 10 doses of 0.20 units). After each press of the switch assembly 318, the infusion pump assembly 100, 100' may provide the user with an audible response via an internal speaker / sound generating device (not shown). Therefore, the user may first press the switch assembly 318, and the infusion pump assemblies 100, 100' may generate a confirmation beep accordingly, thus indicating to the user that the infusion pump assemblies 100, 100' have received a command for 0.20 units of insulin (in this particular embodiment). Since the desired bolus dose is 2.00 units of insulin, the user may repeat this procedure nine more times to achieve a bolus dose of 2.00 units, with the infusion pump assemblies 100, 100' generating a confirmation beep after each press of the switch assembly 318.

[0118] In this particular embodiment, the infusion pump assemblies 100, 100' are described as providing one beep each time the user presses the switch assembly 318, but this is for illustrative purposes only and is not intended to limit the present disclosure. Specifically, the infusion pump assemblies 100, 100' may be configured to provide a single beep for each defined amount of insulin. As discussed above, one press of the switch assembly 318 may be equivalent to 0.20 units of insulin. Thus, the infusion pump assemblies 100, 100' may be configured to provide a single beep for each 0.10 units of insulin. Therefore, if the infusion pump assemblies 100, 100' are configured such that one press of the switch assembly 318 is equivalent to 0.20 units of insulin, then each time the switch assembly 318 is pressed, the infusion pump assemblies 100, 100' may provide the user with two beeps (i.e., one for each 0.10 units of insulin).

[0119] If 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 assembly 100' to acknowledge receipt of the command to administer a 2.00 unit bolus dose of insulin (in contrast to the acknowledgment beeps received with each press of the switch assembly 318). After a defined period (e.g., 2 seconds) has elapsed, the infusion pump assembly 100' may provide the user with an audible acknowledgment regarding the unit amount to be administered via the bolus insulin dose requested by the user. For example, if the infusion pump assembly 100' is programmed by the user so that (in this embodiment) one press of the switch assembly 318 is equivalent to 0.20 units of insulin, the infusion pump assembly 100' may beep 10 times (i.e., 2.00 units is 10 doses of 0.20 units).

[0120] When providing feedback to the user regarding the volume of units administered via a bolus insulin dose, the infusion pump assembly 100, 100' may provide multi-frequency audible confirmation. For example, continuing the above embodiment in which 10 beeps are provided to the user, the infusion pump assembly 100, 100' may group the beeps into groups of five (to facilitate easier counting by the user), and the beeps within each group of five may be rendered by the infusion pump assembly 100, 100' such that each subsequent beep has a higher frequency than the preceding beep (similar to a musical scale). Therefore, continuing with the above embodiment, the injection pump assemblies 100, 100' may render a 1,000 Hz beep, followed by a 1,100 Hz beep, followed by a 1,200 Hz beep, followed by a 1,300 Hz beep, followed by a 1,400 Hz beep (thus completing a group of five beeps), followed by a short pause, then a 1,000 Hz beep, followed by a 1,100 Hz beep, followed by a 1,200 Hz beep, followed by a 1,300 Hz beep, followed by a 1,400 Hz beep (thus completing a second group of five beeps). According to various additional / alternative embodiments, multi-frequency audible confirmation may utilize a variety of timbres with incrementing frequencies. For example, the embodiment may utilize 20 different timbres with incrementing frequencies. However, since the number of timbres can vary depending on the design criteria and user needs, the number of timbres should not be construed as a limitation of this disclosure.

[0121] Once the infusion pump assemblies 100, 100' have completed rendering the multi-frequency audible confirmation (i.e., the 10 beeps described above), the user may press the switch assembly 318 within a defined period (e.g., 2 seconds) to provide a confirmation signal to the infusion pump assemblies 100, 100', indicating that the multi-frequency audible confirmation was accurate and indicated the size of the bolus dose of insulin to be administered (i.e., 2.00 units). Upon receiving this confirmation signal, the infusion pump assemblies 100, 100' may render an audible "confirmation received" sound and (in this particular embodiment) achieve delivery of a 2.00 unit bolus dose of insulin. If the infusion pump assemblies 100, 100' have not received the above confirmation signal, they may render an audible "confirmation failed" sound and will not achieve delivery of the bolus dose of insulin. Therefore, if multi-frequency audible confirmation is inaccurate / does not indicate the size of the bolus dose of insulin to be administered, the user may simply refrain from providing the confirmation signal described above, thereby discontinuing the delivery of the bolus dose of insulin.

[0122] As discussed above, in one exemplary embodiment of the injection pump assembly described above, the injection pump assembly 100' may be used to communicate with a remote control assembly 300. When such a remote control assembly 300 is utilized, the injection pump assembly 100' and the remote control assembly 300 can periodically contact each other to ensure that the two devices are still communicating with each other. For example, the injection pump assembly 100' may "ping" the remote control assembly 300 to ensure that the remote control assembly 300 is present and operational. Furthermore, the remote control assembly 300 may "ping" the injection pump assembly 100' to ensure that the injection pump assembly 100' is still present and operational. If one of the injection pump assembly 100' and the remote control assembly 300 fails to establish communication with the other assembly, the assembly that fails to establish communication may sound a "separation" alarm. For example, suppose the injection pump assembly 100' is in the user's pocket while the remote control assembly 300 is left in the user's car. Therefore, after a defined period, the injection pump assembly 100' may begin sounding a “separation” alarm, indicating that it cannot establish communication with the remote control assembly 300. The user may use the switch assembly 318 to acknowledge / silence this “separation” alarm.

[0123] Since a user may define and administer a bolus insulin dose via the switch assembly 318 of the infusion pump assembly 100' while the remote control assembly 300 is not communicating with the infusion pump assembly 100', the infusion pump assembly 100' may store information about the administered bolus insulin dose in a log file (not shown) stored within the infusion pump assembly 100'. This log file (not shown) may be stored in non-volatile memory (not shown) contained within the infusion pump assembly 100'. When communication is re-established between the infusion pump assembly 100' and the remote control assembly 300, the infusion pump assembly 100' may provide the remote control assembly 300 with the information about the administered bolus insulin dose stored in the log file (not shown) of the infusion pump assembly 100'.

[0124] Furthermore, if the user anticipates separating the remote control assembly 300 from the injection pump assembly 100', the user may configure the injection pump assembly 100' and the remote control assembly 300 to enter "separated" mode (via the menu system described above), thereby eliminating the occurrence of the "separated" alarm described above. However, the devices may continue to "ping" each other so that the injection pump assembly 100' and the remote control assembly 300 can automatically exit "separated" mode when they resume communication with each other.

[0125] Furthermore, if the user anticipates traveling by aircraft, the user may configure the injection pump assembly 100' and the remote control assembly 300 (via the menu system of the remote control assembly 300) to enter an "aircraft" mode, which suspends all data transmissions. During the "aircraft" mode, the injection pump assembly 100' and the remote control assembly 300 may or may not continue to receive data.

[0126] 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 the injectable fluid.

[0127] Steps for checking battery life: The reusable housing assembly 102 may include a rechargeable battery assembly that may be capable of supplying power to the injection pump assembly 100, 100' for approximately three days (when fully charged). Such a rechargeable battery assembly may have a predetermined number of usable times, e.g., a usable life of several years, or other predetermined length of usable time. However, the predetermined life may depend on many factors, including but not limited to climate, daily use, and the number of recharges, one or more of these. Whenever the reusable housing assembly 102 is disconnected from the disposable housing assembly 114, the injection pump assembly 100, 100' may perform a battery check on the above rechargeable battery assembly whenever the switch assembly 318 is pressed for a defined period (e.g., more than two seconds). If it is determined that the above rechargeable battery assembly has been charged above a desired threshold, the injection pump assembly 100, 100' may render a "battery passed" sound. Alternatively, if the above rechargeable battery assembly is determined to be charged below a desired threshold, the injection pump assemblies 100, 100' may render a “low battery” tone. The injection pump assemblies 100, 100' may include components and / or circuits for determining whether the reusable housing assembly 102 has been disconnected from the disposable housing assembly 114.

[0128] Pairing Step: As discussed 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. A pairing process may be performed to achieve communication between the injection pump assembly 100' and the remote control assembly 300. 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 an injection pump assembly (e.g., injection pump assembly 100') may be recorded in a pairing file (not shown) contained within the remote control assembly 300, and the serial number of the remote control assembly 300 may be recorded in a pairing file (not shown) contained within an injection pump assembly (e.g., injection pump assembly 100').

[0129] According to the embodiment, in order 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 contained within the remote control assembly 300 and the switch assembly 318 contained within the injection pump assembly 100' over a defined period of, for example, more than 5 seconds. Upon reaching this defined period, one or more of the remote control assembly 300 and the injection pump assembly 100' may generate an audible signal indicating that the above pairing procedure has been achieved.

[0130] According to another embodiment, the user may detach the reusable housing assembly 102 from the disposable housing assembly 114 before performing the pairing process. Requiring this initial step provides further assurance that the injection pump assembly installed by the user cannot be improperly paired with the remote control assembly.

[0131] If disconnected, the user may enter pairing mode via the input assembly 304 of the remote control assembly 300. For example, the user may enter pairing mode on the remote control assembly 300 via the menu system described above, for example, in combination with the switch assembly 310. The user may be instructed on the display assembly 302 of the remote control assembly 300 to long-press the switch assembly 318 on the injection pump assembly 100'. In addition, the remote control assembly 304 may switch to a low-power mode, for example, to avoid attempting to pair with the remote injection pump assembly. The user may then long-press the switch assembly 318 on the injection pump assembly 100' to put the injection pump assembly 100' into receiving mode and wait for a pairing command from the remote control assembly 300.

[0132] Next, the remote control assembly 300 may transmit a pairing request to the injection pump assembly 100', which may be approved by the injection pump assembly 100'. The injection pump assembly 100' may perform a security check on the pairing request received from the remote control assembly 300, and (if the security check passes) the injection pump assembly 100' may activate the pump pairing signal (i.e., enter active pairing mode). The remote control assembly 300 may perform a security check on the approval received from the injection pump assembly 100'.

[0133] The authorization received from the injection pump assembly 100' may define the serial number of the injection pump assembly 100', and the remote control assembly 300 may display that serial number on the display assembly 302 of the remote control assembly 300. The user may be asked if they wish to pair with the found pump. If the user declines, the pairing process may be interrupted. If the user agrees to the pairing process, the remote control assembly 300 may instruct the user (via the display assembly 302) to press and hold the switch assembly 318 on the injection pump assembly 100'.

[0134] Next, the user may press and hold the switch assembly 318 on the injection pump assembly 100', and also, for example, the switch assembly 310 on the remote control assembly 300.

[0135] The remote control assembly 300 may confirm that the remote switch assembly 310 has been pressed (this may be reported to the injection pump assembly 100'). The injection pump assembly 100' may perform a security check on the confirmation received from the remote control assembly 300 to verify the integrity of the confirmation. If the integrity of the received confirmation cannot be verified, the pairing process is interrupted. If the integrity of the received confirmation can be verified, any existing remote pairing configuration files are overwritten to reflect the newly paired remote control assembly 300, a pump pairing complete signal is activated, and the pairing process is completed.

[0136] In addition, the injection pump assembly 100' may confirm that the switch assembly 318 has been pressed (this may be reported to the remote control assembly 300). The remote control assembly 300 may perform a security check on the confirmation received from the injection pump assembly 100' to verify its integrity. If the integrity of the received confirmation cannot be verified, the pairing process is interrupted. If the integrity of the received confirmation can be verified, the pairing list file in the remote control assembly 300 may be modified to add the injection pump assembly 100'. Typically, the remote control assembly 300 may be able to pair with multiple injection pump assemblies, while the injection pump assembly 100' may only be able to pair with a single remote control assembly. A pairing complete signal may be activated, and the pairing process may be completed.

[0137] Once the pairing process is complete, one or more of the remote control assembly 300 and the injection pump assembly 100' may generate an audible signal indicating that the pairing procedure described above has been successfully completed.

[0138] Step to interrupt bolus dose: If the user wishes to interrupt the bolus dose of insulin being administered by, for example, the infusion pump assembly 100', the user may press the switch assembly 318 (for example, shown in Figures 1 and 2) for a defined period of, for example, more than 5 seconds. When this defined period is reached, the infusion pump assembly 100' may render an audible signal indicating that the above interruption procedure has been achieved.

[0139] The switch assembly 318 is shown positioned on top of the injection pump assemblies 100, 100', but other configurations are possible, and this is for illustrative purposes only and is not intended to limit the disclosure. For example, the switch assembly 318 may be positioned around the injection pump assemblies 100, 100'.

[0140] See also Figure 13-15, which shows an alternative embodiment of the injection pump assembly 400. Similar to pump assemblies 100, 100', the injection pump assembly 400 may include a reusable housing assembly 402 and a disposable housing assembly 404. 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 and 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.

[0141] Similar to the disposable housing assembly 114, the disposable housing assembly 404 may be configured for single use or for use for a specified period, such as three days or any other amount of time. The disposable housing assembly 404 may be configured such that any components of the injection pump assembly 400 that come into contact with the injectable fluid are located on and / or inside the disposable housing assembly 404.

[0142] In this particular embodiment of the injection pump assembly, the injection pump assembly 400 may include a switch assembly 406 positioned around the injection pump assembly 400. For example, the switch assembly 406 may be positioned along the radial edge of the injection pump assembly 400, which may allow for easier use by the user. The switch assembly 406 may be covered with a waterproof membrane configured to prevent water from entering the injection pump assembly 400. The reusable housing assembly 402 may include a main body portion 408 (which houses the mechanical and electrical control assemblies described above) and a locking ring assembly 410 which may be configured to rotate around the main body portion 408 (in the direction of arrow 412).

[0143] Similar to the reusable housing assembly 102 and the disposable housing assembly 114, the reusable housing assembly 402 may be configured to releasably engage with the disposable housing assembly 404. Such a releasable engagement may be achieved, for example, by a screw, twist-lock, or compression-fit configuration. In embodiments where a twist-lock configuration is utilized, the user of the injection pump assembly 400 may first properly position the reusable housing assembly 402 relative to the disposable housing assembly 404, and then rotate the locking ring assembly 410 (in the direction of arrow 412) to releasably engage the reusable housing assembly 402 with the disposable housing assembly 404.

[0144] Through the use of the locking ring assembly 410, the reusable housing assembly 402 may be properly positioned relative to the disposable housing assembly 404 and then releasably engaged by rotating the locking ring assembly 410, thus eliminating the need to rotate the reusable housing assembly 402 relative to the disposable housing assembly 404. Therefore, the reusable housing assembly 402 may be properly aligned with the disposable housing assembly 404 prior to engagement, and such alignment cannot be interfered with 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.

[0145] See also Figure 16-18, which shows an alternative embodiment of the injection pump assembly 500. Similar to pump assemblies 100, 100', the injection pump assembly 500 may include a reusable housing assembly 502 and a disposable housing assembly 504. 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 and to achieve the 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.

[0146] 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 of time, such as three days or any other time. The disposable housing assembly 504 may be configured such that any components of the injection pump assembly 500 that come into contact with the injectable fluid are located on and / or inside the disposable housing assembly 504.

[0147] In this particular embodiment of the injection pump assembly, the injection pump assembly 500 may include a switch assembly 506 positioned around the injection pump assembly 500. For example, the switch assembly 506 may be positioned along the radial edge of the injection pump assembly 500, which may allow for easier use by the user. The switch assembly 506 may be covered with a waterproof membrane and / or an O-ring, or other sealing mechanisms may be included on the handle portion 507 of the switch assembly 506, configured to prevent water from entering the injection pump assembly 500. However, in some embodiments, the switch assembly 506 may include an overmolded rubber button, thus providing functionality as a waterproof seal without the use of a waterproof membrane or O-ring. However, in yet other embodiments, the overmolded rubber button may, in addition, be covered with a waterproof membrane and / or include an O-ring. The reusable housing assembly 502 may include a main body portion 508 (for housing the mechanical and electrical control assemblies described above) and a locking ring assembly 510 which may be configured to rotate around the main body portion 508 (in the direction of arrow 512).

[0148] Similar to the reusable housing assembly 402 and the disposable housing assembly 404, the reusable housing assembly 502 may be configured to releasably engage with the disposable housing assembly 504. Such a releasable engagement may be achieved, for example, by a screw, twist-lock, or compression-fit configuration. In embodiments where a twist-lock configuration is utilized, the user of the injection pump assembly 500 may first properly position the reusable housing assembly 502 relative to the disposable housing assembly 504, and then rotate the locking ring assembly 510 (in the direction of arrow 512) to releasably engage the reusable housing assembly 502 with the disposable housing assembly 404.

[0149] Because the locking ring assembly 510 contained within the injection pump assembly 500 may be higher than the locking ring assembly 410 (i.e., as indicated by arrow 514), the locking ring assembly 510 may include a passage 516 through which the button 506 can pass. Therefore, when assembling the reusable housing assembly 502, the locking ring assembly 510 may be placed on top of the main body portion 508 (in the direction of arrow 518). Once the locking ring assembly 510 is placed on top of the main body portion 508, one or more locking tabs (not shown) may prevent the locking ring assembly 510 from being removed from the main body portion 508. The portion of the switch assembly 506 protruding through the passage 516 may then be pushed into the main body 508 (in the direction of arrow 520), thus completing the installation of the switch assembly 506.

[0150] Although the button 506 is shown in various locations on the injection pump assembly 500, in other embodiments, the button 506 may be located in any desired location on the injection pump assembly 500.

[0151] Through the use of the locking ring assembly 510, the reusable housing assembly 502 may be properly positioned relative to the disposable housing assembly 504 and then releasably engaged by rotating the locking ring assembly 510, thus eliminating the need to rotate the reusable housing assembly 502 relative to the disposable housing assembly 504. Therefore, the reusable housing assembly 502 may be properly aligned with the disposable housing assembly 504 prior to engagement, and such alignment cannot be interfered with during the engagement process. The locking ring assembly 510 may include a latching mechanism (not shown) that prevents rotation of the locking ring assembly 510 until the reusable housing assembly 502 and the disposable housing assembly 504 are properly positioned relative to each other. The passage 516 may be elongated to allow movement of the locking ring 510 around the switch assembly 506.

[0152] See also Figures 19A-19B and 20-21, which show various diagrams of the injection pump assembly 500, which is shown to include a reusable housing assembly 502, a switch assembly 506, and a main body 508. As discussed above, the main body portion 508 may include multiple components, and its embodiments may include, but are not limited to, a volume sensor assembly 148, a printed circuit board 600, a vibration motor assembly 602, a shape memory actuator anchor 604, a switch assembly 506, a battery 606, an antenna assembly 608, a pump assembly 106, a measuring valve assembly 610, a volume sensor valve assembly 612, and a reservoir valve assembly 614. For improved clarity, the printed circuit board 600 has been removed from Figure 19B to allow visibility of the various components located beneath the printed circuit board 600.

[0153] Various electrical components that can be electrically connected to the printed circuit board 600 may utilize spring-loaded terminals that enable electrical connection without the need for soldering. For example, the vibration motor assembly 602 may utilize a pair of spring-loaded terminals (one positive terminal and one negative terminal) configured to press against corresponding conductive pads on the printed circuit board 600 when the vibration motor assembly 602 is positioned on the printed circuit board 600. However, in exemplary embodiments, the vibration motor assembly 602 is soldered directly to the printed circuit board.

[0154] 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. Patent Nos. 5,575,310 and 5,755,683, assigned to DEKA Products Limited Partnership, and U.S. Patent Publications US2007 / 0228071A1, US2007 / 0219496A1, 2007 / 0219480A1, and U.S.2007 / 0219597A1, which are incorporated herein by reference in their entirety.

[0155] The vibration motor assembly 602 may be configured to provide vibration-based signals to the user of the injection pump assembly 500. For example, if the voltage of the battery 606 (which powers the injection pump assembly 500) falls below the minimum allowable voltage, the vibration motor assembly 602 may vibrate the injection pump assembly 500 to provide vibration-based signals to the user of the injection pump assembly 500. The shape memory actuator anchor 604 may provide a mounting point for the shape memory actuator (e.g., shape memory actuator 112). As discussed above, the shape memory actuator 112 may be, for example, a conductive shape memory alloy wire that changes shape with temperature. The temperature of the shape memory actuator 112 may be changed by a heater or, more conveniently, by the application of electrical energy. Thus, one end of the shape memory actuator 112 may be firmly attached (i.e., moored) 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. Therefore, the length of the shape memory actuator 112 may be controlled by applying electrical energy to the shape memory actuator 112, and thus the valve assembly and / or pump actuator to which it is attached may be operated.

[0156] The antenna assembly 608 may be configured to enable wireless communication, for example, between the injection pump assembly 500 and the remote control assembly 300 (Figure 11). As discussed above, the remote control assembly 300 may allow a user to program the injection pump assembly 500 to configure, for example, a bolus injection event. As discussed above, the injection pump assembly 500 may include one or more valve assemblies configured to control the flow rate of the injectable fluid through the fluid path (within the injection pump assembly 500), and the pump assembly 106 may be configured to deliver the injectable fluid from the fluid path to the user. In this particular embodiment of the injection pump assembly 500, it is shown that the injection pump assembly 500 includes three valve assemblies, namely, a measuring valve assembly 610, a volume sensor valve assembly 612, and a reservoir valve assembly 614.

[0157] As discussed above and also with reference to Figure 21, the injectable fluid may be stored in the reservoir 118. To achieve delivery of the injectable fluid to the user, processing logic (not shown) contained within the injection pump assembly 500 may energize a shape memory actuator 112, which can be anchored on one end using a shape memory actuator anchor 604. Also with reference to Figure 22A, the shape memory actuator 112 may result in the activation of the pump assembly 106 and the reservoir valve assembly 614. The reservoir valve assembly 614 may include a reservoir valve actuator 614A and a reservoir valve 614B, and the activation of the reservoir valve assembly 614 may result in the downward displacement of the reservoir valve actuator 614A and the closing of the reservoir valve 614B, resulting in effective isolation of the reservoir 118. Furthermore, the pump assembly 106 may include a pump plunger 106A and a pump chamber 106B, and activation of the pump assembly 106 may displace the pump plunger 106A downward into the pump chamber 106B, resulting in a displacement of the injectable fluid (in the direction of arrow 616).

[0158] The volume sensor valve assembly 612 may include a volume sensor valve actuator 612A and a volume sensor valve 612B. See also Figure 22B, the volume sensor valve actuator 612A may be closed via a spring assembly that provides mechanical force to seal the volume sensor valve 612B. However, when the pump assembly 106 is activated, if the displaced injectable fluid is at sufficient pressure to overcome the mechanical sealing force of the volume sensor valve assembly 612, the displacement of the injectable fluid occurs in the direction of arrow 618. This may result in filling of the volume sensor chamber 620 contained within the volume sensor assembly 148. Through the use of a speaker assembly 622, a port assembly 624, a reference microphone 626, a spring diaphragm 628, and a constant volume microphone 630, the volume sensor assembly 148 may determine the volume of the injectable fluid contained within the volume sensor chamber 620.

[0159] See also Figure 22C. Once the volume of the injectable fluid contained within the volume sensor chamber 620 is calculated, the shape memory actuator 632 may be energized, resulting in the activation of a measuring valve assembly 610, which may include a measuring valve actuator 610A and a measuring valve 610B. Once activated, the mechanical energy exerted on the injectable fluid within the volume sensor chamber 620 by the spring diaphragm 628 may cause the injectable fluid within the volume sensor chamber 620 to be displaced into the user's body (in the direction of arrow 634) through a disposable cannula 138.

[0160] See also Figure 23, which shows an exploded view of the injection pump assembly 500. The shape memory actuator 632 may be anchored to the shape memory actuator anchor 636 (on its first end). In addition, the other end of the shape memory actuator 632 may be used to provide mechanical energy to the valve assembly 638, which can activate the measuring 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 injection pump assembly 500. The valve assembly 638 may be used in conjunction with the shape memory actuator 112 to activate the pump plunger 106A. The measuring valve 610B, volume sensor valve 612B, and / or reservoir valve 614B may be built-in valves configured to allow installation during the assembly of the injection pump assembly 500 by pushing the valve upward into the underside of the main body portion 508.

[0161] See also Figures 24 and 25A-25D for a more detailed view of the pump assembly 106. The pump actuator assembly 644 may include a pump actuator support structure 646, a biasing spring 648, and a lever assembly 650.

[0162] See also Figures 26A-26B and 27A-27B for a more detailed view of the measuring valve assembly 610. As discussed above, the valve assembly 638 may activate the measuring valve assembly 610.

[0163] See also Figures 28A-28D, the injection pump assembly 500 may include a measuring valve assembly 610. As discussed above, the valve assembly 638 may be activated via a shape memory actuator 632 and an actuator assembly 640. Thus, in order to inject the amount of injectable fluid stored in the volume sensor chamber 620, the shape memory actuator 632 may need to activate the valve assembly 638 over a fairly long period (e.g., one minute or more). Since this would consume a considerable amount of power from the battery 606, the measuring valve assembly 610 may allow for a temporary activation of the valve assembly 638, at which point the measuring valve latch 656 may prevent the valve assembly 638 from returning to its non-activated position. The shape memory actuator 652 may be anchored on a first end using an electrical contact 654. The other end of the shape memory actuator 652 may be connected to the valve latch 656. When the shape memory actuator 652 is activated, it may pull the valve latch 656 forward and release the valve assembly 638. Thus, the measuring valve assembly 610 may be activated via the shape memory actuator 632. When the measuring valve assembly 610 is activated, the valve latch 656 may automatically lock the valve assembly 638 in the activated position. The shape memory actuator 652 may be activated to pull the valve latch 656 forward and release the valve assembly 638. Assuming the shape memory actuator 632 is no longer activated, once the valve latch 656 releases the valve assembly 638, the measuring valve assembly 610 may enter a deactivated state. Thus, throughout the use of the measuring valve assembly 610, the shape memory actuator 632 does not need to be activated for the entire time it takes to inject the amount of injectable fluid stored in the volume sensor chamber 620.

[0164] As discussed above, the injection pump assemblies described above (e.g., injection pump assemblies 100, 100', 400, 500) may include an external injection set 134 configured to deliver an injectable fluid to the user. The external injection set 134 may include a cannula assembly 136, which may include a needle or disposable cannula 138, and a tubing assembly 140, which may also be referred to as a tubing set. The tubing assembly 140 may be in fluid communication with a reservoir 118 and the cannula assembly 138, for example, through a fluid path, either directly or through a cannula interface 142.

[0165] See also Figure 29, which shows an alternative embodiment of an injection pump assembly 700 configured to house a portion of the tubing assembly 140. Specifically, the injection pump assembly 700 may include a peripheral tubing storage assembly 702 configured to allow a user to wind a portion of the tubing assembly 140 around the injection pump assembly 700 (similar to a yo-yo). The peripheral tubing storage assembly 702 may be positioned around the injection pump assembly 700. The peripheral tubing storage assembly 702 may be configured as an open valley into which a portion of the tubing assembly 140 can be wound. Alternatively, the peripheral pipe storage assembly 702 may include one or more segmented sections 704, 706 that form a plurality of narrower valleys, which can be sized to create an interference fit between the walls of the narrower valleys and the outer surface of a portion of the pipes 140. When the peripheral pipe storage assembly 705 includes a plurality of segmented sections 704, 706, the resulting narrower valleys may be wound around the injection pump assembly 700 in a helical manner (similar to the threads of a screw).

[0166] See also Figure 30-31, which shows an alternative embodiment of an injection pump assembly 750 configured to house a portion of the tubing assembly 140. Specifically, the injection pump assembly 750 may include a peripheral tubing storage assembly 752 configured to allow a user to wind a portion of the tubing assembly 140 around the injection pump assembly 750 (again, similarly to a yo-yo). The peripheral tubing storage assembly 752 may be positioned around the injection pump assembly 750. The peripheral tubing storage assembly 752 may be configured as an open valley into which a portion of the tubing assembly 140 is wound. Alternatively, the peripheral tubing storage assembly 752 may include one or more segmented portions 754, 756 that form a plurality of narrower valleys, which can be sized to create an interference fit between the walls of the narrower valleys and the outer surface of the portion of the tubing 140. When the peripheral pipe storage assembly 752 includes multiple divisions 754, 756, the resulting narrower valleys may be wound around the injection pump assembly 750 in a helical manner (again, similar to screw threads).

[0167] The injection pump assembly 750 may include a pipe retainer assembly 758. The pipe retainer assembly 758 may be configured to releasably secure the pipe assembly 140 so as to prevent the pipe assembly 140 from unwinding around the injection pump assembly 750. In one embodiment of the pipe retainer assembly 758, the pipe retainer assembly 758 may include a downward-facing pin assembly 760 positioned above an upward-facing pin assembly 762. The combination of pin assemblies 760, 762 may define a "clamping point" through which the pipe assembly 140 can be pushed. Thus, the user may wind the pipe assembly 140 around the injection pump assembly 750, with each loop of the pipe assembly 140 secured within the peripheral pipe storage assembly 752 via the pipe retainer assembly 758. If the user desires to extend the unfixed portion of the pipe assembly 140, the user may release one loop of the pipe assembly 140 from the pipe retainer assembly 758. Conversely, if the user desires to shorten the unfixed portion of the pipe assembly 140, the user may fix one additional loop of the pipe assembly 140 within the pipe retainer assembly 758.

[0168] See also Figures 32-33, which show an exemplary embodiment of the injection pump assembly 800. Similar to injection pump assemblies 100, 100', 400, and 500, the injection pump assembly 800 may include a reusable housing assembly 802 and a disposable housing assembly 804.

[0169] See also Figures 34A-34B, similar to the injection pump assembly 100, the reusable housing assembly 802 may be configured to releasably engage with the disposable housing assembly 804. Such a releasable engagement may be achieved, for example, by a screw, twist-lock, or compression-fit configuration. The injection pump assembly 800 may include a locking ring assembly 806. For example, the reusable housing assembly 802 may be properly positioned relative to the disposable housing assembly, and the locking ring assembly 806 may be rotated to releasably engage with both the reusable housing assembly 802 and the disposable housing assembly 804.

[0170] The locking ring assembly 806 may include a small ridge 808 having a spring-actuated tab 2980 that can facilitate the rotation of the locking ring assembly 806. In addition, for example, the position of the small ridge 808 relative to the tab 810 of the disposable housing assembly 804 may provide evidence that the reusable housing assembly 802 is fully engaged with the disposable housing assembly 804. For example, when the reusable housing assembly 802 is properly aligned with the disposable housing assembly 804, as shown in Figure 34A, the small ridge 808 may be aligned in a first position relative to the tab 810. Once the fully engaged state is achieved, the rotating locking ring assembly 806 may align the small ridge 808 in a second position relative to the tab 810, as shown in Figure 34B.

[0171] See also Figures 35A-35C and 36-38A, similar to the reusable housing assembly 102, the reusable housing assembly 802 may include a mechanical control assembly 812 (which may include a valve assembly 814 shown in Figure 36, for example, including one or more valves and one or more pumps for dispensing and controlling the flow rate of injectable fluid). The reusable housing assembly 802 may also include an electrical control assembly 816, which may be configured to provide control signals to the mechanical control assembly 812 and to achieve the delivery of injectable fluid to the user. The valve assembly 814 may be configured to control the flow rate of injectable fluid through the fluid path, and the pump assembly may be configured to dispensing injectable fluid from the fluid path to the user.

[0172] The mechanical control assembly 812 and the electrical control assembly 816 may be contained within a housing defined by the substrate 818 and the body 820. In some embodiments, one or more of the substrate 818 and the body 820 may provide electromagnetic shielding. In such embodiments, electromagnetic shielding can prevent and / or reduce electromagnetic interference received by and / or generated by the electrical control assembly 816. In addition / alternatively, an EMI shielding body 822 may be included, as shown in Figures 36 and 37. The EMI shielding body 822 may provide shielding against generated and / or received electromagnetic interference.

[0173] The reusable housing assembly 802 may include a switch assembly that can be configured to receive user commands (e.g., for bolus delivery, pairing with a remote control assembly, or equivalent). The switch assembly may include a button 824 that can be located in an opening 826 of the body 820. For example, as shown in Figure 35B, the locking ring assembly 806 may include a radial slot 828 that can be configured to allow the locking ring assembly 806 to rotate relative to the body 820, while still providing easy access to the button 824.

[0174] See also Figures 39A-39C, the electrical control assembly 816 may include a printed circuit board 830 and a battery 832. The printed circuit board 830 may include various control electronics for monitoring and controlling the amount of injectable fluid that has been and / or is being dispensed. For example, the electrical control assembly 816 may measure the amount of injectable fluid that has just been dispensed and determine whether a sufficient amount of injectable fluid has been dispensed based on the dose required by the user. If a sufficient amount of injectable fluid has not been dispensed, the electrical control assembly 816 may determine that more injectable fluid should be dispensed. The electrical control assembly 816 may provide appropriate signals to the mechanical control assembly 812 so that additional required doses can be dispensed, or the electrical control assembly 816 may provide appropriate signals to the mechanical control assembly 812 so that additional doses can be dispensed together with the next dose. Alternatively, if an excess of injectable fluid is dispensed, the electrical control assembly 816 may provide an appropriate signal to the mechanical control assembly 812 so that a smaller amount of injectable fluid may be dispensed in the next dose. The electrical control assembly 816 may include one or more microprocessors. In exemplary embodiments, the electrical control assembly 816 may include three processors. One processor (for example, a CC2510 microcontroller / RF transceiver available from Chipcon AS (Oslo, Norway), but not limited to this) may be dedicated to wireless communication, for example, to communicate with the remote control assembly. Two additional microprocessors (an embodiment of which may include, but is not limited to, the MSP430 microcontroller available from Texas Instruments Inc. (Dallas, Texas)) may be dedicated to issuing and executing commands (for example, to dispense doses of injectable fluid, process feedback signals from a volumetric device, and equivalent).

[0175] As shown in Figure 35C, the substrate 818 may provide access to electrical contacts 834, which can be electrically connected 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) that can be configured to facilitate proper alignment with the disposable housing assembly 804 through cooperative features (e.g., tabs) of the disposable housing assembly 804. In addition, as shown in Figures 40A-40C, 41A-41B, and 42A-42C, the substrate 818 may include various features for mounting the valve assembly 814 and the electrical control assembly 816, as well as for providing access to the disposable housing assembly 804 by the valve assembly 814.

[0176] The locking ring assembly 806 may include gripping inserts 840, 842, which may include an elastomer or textured material, that can facilitate gripping and twisting the locking ring assembly 806 for, for example, to engage / disengage the reusable housing assembly 802 and the disposable housing assembly 804. In addition, the locking ring assembly 806 may include sensing components (e.g., magnets 844) that can interact with components of the reusable housing assembly 802 (e.g., Hall effect sensors) to provide an indicator of the properties of the interlocking components (e.g., in some embodiments, one or more of the disposable housing assembly 804, the charging station, or the filling station) and / or whether the reusable housing assembly 802 is properly engaged with the interlocking components. In exemplary embodiments, a Hall effect sensor (not shown) may be located on a pump printed circuit board. The Hall effect sensor may detect when the locking ring has been rotated to the closed position. Therefore, the Hall effect sensor, together with the magnet 844, may provide a system for determining whether the locking ring has been rotated to the closed position.

[0177] The sensing component (magnet) 844 may operate together with the reusable housing assembly component, i.e., in the exemplary embodiment, with the Hall effect sensor, to provide a determination of whether the reusable housing assembly is properly mounted to the intended component or device. The locking ring assembly 806 must not pivot without being mounted to a component, i.e., the disposable housing assembly 804, the dust cover, or the charger. Thus, the sensing component may function together with the reusable housing assembly component to provide several advantageous safety features to the injection pump system. These features may include, but are not limited to, one or more of the following: If the system does not detect that the reusable parts, e.g., valves and pump components, are mounted to the disposable assembly, the dust cover, or the charger, the system may notify, alert, or alarm the user because the reusable parts may be susceptible to contamination or damage that could impair the integrity of the reusable assembly. Thus, the system may provide an integrity alarm to alert the user of a potential threat to the integrity of the reusable assembly. Also, if the system senses that the reusable assembly is mounted to the dust cover, the system may save power by turning off or reducing power. This can offer more efficient use of power when the reusable assembly is not connected to components that need to interact with each other.

[0178] See also Figures 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, the locking mechanism illustrated and described above with respect to Figure 38A, for example, may include a spring-actuated tab 2980 assembly. In some embodiments, the tab 2980 includes a sensing component, which in some embodiments may be a magnet 2986. See also Figure 137. A cross-sectional view at “A” of the reusable housing assembly 2972 ​​above the disposable housing assembly 2974 in the “unlocked” position is shown. In some embodiments, the "locked" and "unlocked" positions may also be visually indicated to the user / patient using icons 2976, 2978 which may be molded, etched, and / or printed on the disposable housing assembly 2974, indicating whether the reusable housing assembly 2972, or in some embodiments, the filling adapter, is in a locked or unlocked 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, icons 2976, 2978 may be in any form that can indicate "locked" and "unlocked" or similar indicators to help the user / patient understand 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 unlocked orientation. See also Figure 138, which shows a cross-sectional view at "A" of the reusable housing assembly 2972 ​​attached to the disposable housing assembly 2974 in the unlocked orientation / position. Tab 2080 is in the unlocked position. Now see Figure 139, which shows a cross-sectional view at "A" of the reusable housing assembly 2972 ​​attached to the disposable housing assembly 2974 in the unlocked orientation / position.As may be shown in the figures, tab 2980 moves toward disposable housing assembly 2974, leaving space 2984 above tab 2980 within the reusable housing assembly 2972. When tab 2980 moves from the unlocked position (shown in Figure 138) to the locked position (shown in Figure 139), in some embodiments, an audible "click" and a tactile "click" may be detected by the user / patient. This can be beneficial for several reasons, including the fact that the user / patient may only hear an audible "click" if the reusable housing assembly 2972 ​​and disposable housing assembly 2974 (or, in various embodiments, a dust cover or charger) are in the correct orientation and fully locked position. This can assure the user / patient that the infusion pump assembly is in the correct fully locked position. Therefore, in various embodiments, an audible "click" may be heard when the disposable housing assembly 2974 and the reusable housing assembly 2972 ​​are mounted, and the infusion pump assemblies may include two safety checks that they are fully locked: 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 slanted feature on which the tab 2980 assembly sits as the reusable housing assembly 2972 ​​is rotated relative to the disposable housing assembly 2974 from an unlocked position to a locked position. At the slanted end, in some embodiments, a recess or ridge of the disposable housing assembly 2974 allows the tab 2980, actuated by the spring 2982, to "click" into the recess / ridge. Other embodiments that enable audible and / or tactile indicators for the user / patient may be used in various embodiments.

[0179] The reusable housing assembly 802 may be attached to a number of different components, including, but not limited to, a disposable housing assembly, a dust cover, or a battery charger / battery charging station. In each case, a Hall effect sensor may detect that the locking ring is in the closed position, and thus the reusable housing assembly 802 is releasably engaged to the disposable housing assembly, a dust cover, or a battery charger / battery charging station (or another component). The injection pump system may determine the component to which it is attached by using an AVS system (which may also be called a volumetric sensor), which is described in more detail below, or by electrical contacts. Referring here to Figures 38B-38D, one embodiment of a dust cover (e.g., dust cover 839) is shown. In an exemplary embodiment, the dust cover 839 may include features 841, 843, 845, and 847 such that the locking ring of the reusable housing assembly 802 can releasably engage with the dust cover 839. In addition, the dust cover 839 may further include recessed areas 849 for accommodating valve and pump features of the reusable housing assembly 804. Referring also to Figures 140A-140D, in some embodiments, various embodiments of the dust cover 839, 2988 may include a sealing assembly 2990 which can be overmolded to provide a complete seal of the dust cover 839, 2988 to the reusable housing assembly 2972. The sealing assembly 2990 is overmolded as shown in Figure 140D, a cross-sectional view of section D in Figure 140C. In addition, in some embodiments of the dust cover 2988, as may be shown in Figures 140A and 140B, the dust cover 2988 may include icons 2976, 2978.As discussed above, icons 2976, 2978 may be molded, etched, and / or printed on the dust cover 2988 and may indicate "locked" and "unlocked" or similar indicators, and / or indicate whether the reusable housing assembly 2972 ​​is in a locked or unlocked position relative to the dust cover 2988, in any form, to assist the user / patient understanding of the orientation / position between the reusable housing assembly 2972 ​​and the dust cover 2988. For example, with respect to the dust cover, the AVS system may determine that the dust cover is connected to the reusable housing assembly rather than to the disposable housing assembly. The AVS system may distinguish between using a reference table or other comparison data and comparing the measured data to data from a characteristic dust cover or an empty disposable housing assembly. With respect to the battery charger, the battery charger may include electrical contacts in exemplary embodiments. When the reusable housing assembly is attached to the battery charger, the injection pump assembly electronic system may sense that contact has been made and thus indicate that the reusable housing assembly is attached to the battery charger.

[0180] See also Figures 43A-45B and 44A-44C, which show embodiments of the valve assembly 814, which may include one or more valves and one or more pumps. Similar to the injection pump assemblies 100, 100', 400, and 500, the valve assembly 814 may generally include a reservoir valve 850, a plunger pump 852, a volume sensor valve 854, and a measuring valve 856. As previously described, the reservoir valve 850 and the plunger pump 852 may be actuated by a shape memory actuator 858, which can be anchored to a shape memory actuator anchor 860 (on the first end). In addition, the measuring valve 856 may be actuated via a valve actuator 862 by a shape memory actuator 864, which can be anchored to a shape memory actuator anchor 866 (on the first end). As discussed above, the measuring valve may be held in the open position via a measuring valve latch assembly 868. The measuring valve 856 may be released via the operation of a shape memory actuator 870, which can be anchored (on the first end) by a shape memory actuator anchor 872. In some embodiments, the shape memory actuator anchor 860 may be embedded in a reusable housing assembly. Using this process during manufacturing ensures that the shape memory length actuator 858 is installed and maintains the desired length and tension / strain.

[0181] See also Figures 45A-45B and 46A-46E, a shape memory actuator 858 (which may include, for example, one or more shape memory wires) may actuate a plunger pump 852 via an actuator assembly 874. The actuator assembly 874 may include a biasing spring 876 and a lever assembly 878. The actuator assembly 874 may actuate both the plunger pump 852 and the measuring valve 850.

[0182] See also Figures 47A-47B, the measuring valve 856 may be actuated by a shape memory actuator 864 via a valve actuator 862 and a lever assembly 878. Once actuated, the measuring valve latch assembly 868 may hold the measuring valve 856 in the open position. The measuring valve latch assembly 868 is actuated by a shape memory actuator 870 to release the measuring valve 856, allowing it to return to the closed position.

[0183] The disposable housing assembly 804 may be configured for single use or for use over a specified period, such as three days or any other time. The disposable housing assembly 804 may be configured such that any components in the injection pump assembly 800 that come into contact with the injectable fluid can be placed on and / or inside the disposable housing assembly 804. Thus, the risk of contaminating the injectable fluid can be reduced.

[0184] See also Figures 48 and 49A-49C, the disposable housing assembly 804 may include a base portion 900, a membrane assembly 902, and an upper portion 904. The base portion 900, together with the membrane assembly 902, may include a recess 906 defining a reservoir 908 for receiving an injectable fluid (not shown), such as insulin. See also Figures 50A-50C, the recess 906 may be formed at least partially by and integrated with the base portion 900. The membrane assembly 902 may be tightly engaged with the base portion 900 by, for example, compression clamping between the base portion 900 and the upper portion 904. The upper portion 904 may be attached to the base portion 900 by conventional means such as adhesive, heat fusion, ultrasonic welding, and compression fitting. In addition / alternatively, the membrane assembly 902 may be attached to the base portion 900 by means of, for example, adhesive, ultrasonic welding, thermal fusion, and equivalent, to provide a seal between the membrane assembly 902 and the base portion 900.

[0185] See also Figures 141A-141B, which show embodiments of the disposable housing assembly 2974 without the upper portion or membrane assembly. Referring to Figure 141B, an enlarged section of the pump chamber 106B is shown, as indicated by "B" in Figure 141A. In some embodiments, a groove 2992 is included on the wall of the pump chamber. In some embodiments, the groove may allow fluid to flow while the pump plunger 106A is fully actuated, and thus prevent the pump plunger 106A from sealing off the outflow from the pump chamber 106B. Figures 142B and 142C are cross-sectional views of Figure 142A obtained in sections "B" and "C", respectively. The groove 2992 may be found inside the pump chamber 106B.

[0186] See also Figures 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, but in other embodiments may be filters of different sizes or types, e.g., 5-micron, 15-micron filters, and / or GORTEX filters.

[0187] Still referring to Figures 48 and 50A, the recess 906 includes a raised portion 901, which in the exemplary embodiment includes a region 903 surrounding a fluid opening 905 connected to a fluid line. In the exemplary embodiment, the raised portion 901 extends around the recess 906. However, in other embodiments, the raised portion 901 may not extend around the entire perimeter but may be partially around it. In some embodiments, the region 903 surrounding the fluid opening 905 may be shaped as shown in the exemplary embodiment, including an angled portion with an angle of 45 degrees, but in other embodiments, the angle may be larger or smaller. In some embodiments, the pump may not generate a vacuum sufficient to crush the reservoir to remove the entire volume of fluid that may be stored in the reservoir. The raised portion 901 may act to minimize wasted fluid.

[0188] In exemplary embodiments, the fluid openings 905 may include three openings, but in other embodiments, they may include more or fewer openings. The fluid openings 905 may be surrounded by a raised region 903. In exemplary embodiments, the fluid openings 905 may be narrow in the center and thus generate surface tension that can prevent air from being drawn into the openings. In exemplary embodiments, this region may be designed to encourage air present in the reservoir to be drawn above one of the fluid openings 905 rather than being drawn through the fluid openings 905 into the fluid line. In addition, there may be more than one fluid opening 905 so that if a bubble is trapped above one opening, the air does not have to prevent the fluid from flowing through the other two openings.

[0189] See also Figures 144A-144E, which illustrate another embodiment of the disposable housing assembly 2974. In these embodiments, as may be shown in Figure 144B, which shows an enlarged section of section "B" as shown in Figure 144A, and as may be shown in Figure 144D, which shows an enlarged section of section "D" as shown in Figure 144C, Figure 144E is an explanatory diagram of a bubble trap, in which the bubble trap 2998 and the raised region 3000, as well as the radius 3006 and the relief 3016 relative to the partition wall, are included in the reservoir 3002. In this embodiment, the bubble trap 2998 is located around the wall and radius 3006 of the reservoir 3002. However, within the region of the raised region 3000, the bubble trap 2998 includes an outlet section. In the non-outlet section surrounding the reservoir 3002, the bubble trap 2998 essentially consists of two parts, such as a tapered section 3008 that narrows down to the bottom section 3010. In the outlet section, the tapered portion 3008 terminates as the end of the tapered portion 3014, and the bottom portion 3010 continues to the reservoir outlet 3004 in the upward-sloping portion 3012. The reservoir 3002 includes a membrane (not shown) that, together with the raised region 3000 and the upward-sloping portion 3012, essentially forms a "tunnel" between the membrane and the fluid outlet.

[0190] As the fluid in the reservoir is discharged from the reservoir, the membrane (not shown) moves toward the reservoir wall 3002. In the embodiments shown in Figures 144A-144D, the fluid tends to collect at the bottom portion 3010 of the bubble trap 2998, but the bubbles do not. Rather, to the extent that air is present, the bubbles tend to collect at the tapered portion 3008 of the bubble trap 2998. In the raised region 3000 where the tapered portion 3008 of the bubble trap 2998 terminates at the end of the tapered portion 3014, the bubbles, to the extent that they are present, are less likely to enter the upward sloping portion 3012 and therefore less likely to be discharged through the outlet of the reservoir 3004.

[0191] Therefore, as the fluid is discharged through the outlet of reservoir 3004, no air is drawn out through the outlet of reservoir 3004. Embodiments shown in Figures 144A-144D may be beneficial for many reasons, including, but not limited to, reducing the amount of air discharged from reservoir 3002 into the fluid path within the disposable housing assembly 2974. Because bubbles have a greater surface tension than the fluid, bubbles will no longer tend to accumulate at the bottom portion 3010 of the bubble trap 2998, and furthermore, will no longer tend to flow over the end of the tapered portion 3014 onto the upward sloping portion 3012 and flow through the outlet of reservoir 3004.

[0192] See also Figures 51A-51C, the disposable housing assembly 804 may also include a fluid path cover 910. The fluid path cover 910 may be housed in a cavity 912 formed on / within the base portion 900. In some embodiments, the fluid path cover 910 may include at least a portion of one or more channels (e.g., channel 914). The channels included in the fluid path cover 910 may fluidly connect to one or more volcano valve features (e.g., volcano valve 916) included on the base portion 900. The volcano valve 916 may include a projection having an opening extending through it. In addition, the fluid path cover 910 and the base portion 900 may each define a portion of a recess (e.g., recessed portions 918, 920, included in the base portion 900 and the fluid path cover 910, respectively) for fluid connection to an injection set (e.g., including a cannula 922). The cannula 922 may be connected to the disposable housing assembly 804 by conventional means (e.g., adhesive, heat fusion, compression fitting, or equivalent). A fluid path may be defined between the reservoir 908 and the cannula 922 for the delivery of injectable fluid to the user via an injection set, defined by a volcano valve (e.g., volcano valve 916) on the fluid path cover 910 and base portion 900. 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 exemplary embodiments, 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., bonding, heat fusion, ultrasonic welding, compression fitting, or equivalent) to achieve a substantially fluid-sealed seal between the fluid path cover 910 and the base portion 900.

[0193] See also Figures 54A-54C, the disposable housing assembly 804 may further include a valve cover 924. The valve cover 924 may be positioned at least partially to cover the volcano valve (e.g., volcano valve 916) and pump recess 926 contained on / in the base portion 900. The valve cover 924 may include a flexible material that can be selectively engaged with, for example, the volcano valve by the reservoir valve 850, volume sensor valve 854, and measuring valve 856 of the reusable housing assembly 802, for example, to control the flow rate of the injectable fluid. In addition, the valve cover 924 may be elastically deformed into the pump recess 926 by the plunger pump 852 to achieve the delivery of the injectable fluid. The valve cover 924 may be engaged between the base portion 900 and the upper portion 904 of the disposable housing assembly 804 to form a seal 928 between the valve cover 924 and the base portion 900. For example, in the exemplary embodiment, the valve cover 924 may be overmolded onto the base portion 900. In other embodiments, the valve cover 924 may be compressed and clamped between the base portion 900 and the upper portion 904 to form a seal 928. In addition / alternatively, the valve insert may be connected to one or more of the base portion 900 and the upper portion 904 by, for example, adhesive, heat fusion, or equivalent.

[0194] See also Figures 53A-C, the upper portion 904 may include alignment tabs 930, 932 which may be configured to be at least partially received in openings 836, 838 of the substrate 818 of the reusable housing assembly 802, in order to ensure proper alignment between the reusable housing assembly 802 and the disposable housing assembly 804. In addition, the upper portion 904 may include one or more radial tabs 934, 936, 938, 940 which may be configured to engage with the cooperating tabs 942, 944, 946, 948 of the locking ring assembly 806. One or more radial tabs (e.g., radial tab 940) may include a stopper (e.g., an alignment tab stopper 950 which may be used for welding, a tab that positions and fits into a recess to be ultrasonically welded) which may prevent further rotation of the locking ring assembly 806 once the reusable housing assembly 802 and the disposable housing assembly 804 are fully engaged.

[0195] As discussed above, the valve insert 924 may enable the delivery and flow of an injectable fluid by the reservoir valve 850, plunger pump 852, volume sensor valve 854, and measuring valve 856. Accordingly, the upper portion 904 may include one or more openings (e.g., openings 952, 954, 956) that can expose at least a portion of the valve insert 924 for operation by the reservoir valve 850, plunger pump 852, volume sensor valve 854, and measuring valve 856. In addition, the upper portion 904 may include one or more openings 958, 960, 962 that can be configured to allow the filling volume to be controlled during filling of the reservoir 908, as will be discussed in more detail below. The reservoir assembly 902 may include ribs 964, 966, 968 (e.g., as shown in Figure 52A) that can at least partially receive one of the openings 958, 960, 962. As will be discussed in more detail below, a force may be applied to one or more of the ribs 964, 966, and 968 to reduce the volume of reservoir 908, at least temporarily.

[0196] In some embodiments, it may be desirable to provide a seal between the reusable housing assembly 802 and the disposable housing assembly 804. Therefore, the disposable housing assembly 804 may include a sealing assembly 970. The sealing assembly 970 may include an elastomer member that, for example, can provide a compressible rubber or plastic layer between the reusable housing assembly 802 and the disposable housing assembly 804 when engaged, thus preventing accidental engagement and disengagement and penetration by external fluids. For example, the sealing assembly 970 may be a watertight assembly, thus allowing the user to wear the injection pump assembly 800 while swimming, bathing, or exercising.

[0197] For example, similar to the disposable housing assembly 114, the disposable housing assembly 802 may, in some embodiments, be configured to allow the reservoir 908 to be filled multiple times. However, in some embodiments, the disposable housing assembly 114 may be configured such that the reservoir 908 does not need to be refilled. See also Figure 57-64, the refill adapter 1000 may be configured to connect to the disposable housing assembly 804 for refilling the reservoir 908 using a syringe (not shown). The refill adapter 1000 may include locking tabs 1002, 1004, 1006, 1008 which can be configured to engage with the radial tabs 934, 936, 938, 940 of the disposable housing assembly 804, substantially the same as the tabs 942, 944, 946, 948 of the locking ring assembly 806. Therefore, the filling adapter 1000 may be releasably 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, thereby releasably engaging the locking tabs 1002, 1004, 1006, 1008 with the radial tabs 934, 936, 938, 940.

[0198] The filling adapter 1000 may further include a filling aid 1010, which may include a guide passage 1012 configured to guide, for example, the needle of a syringe (not shown) to the partition wall of the disposable housing assembly 804, thereby enabling the reservoir 908 of the disposable housing assembly 804 to be filled by the syringe. In some embodiments, the guide passage 1012 may be an angled slope or other stepped angled slope to further guide the syringe to the partition wall. The filling adapter 1000 may facilitate filling the reservoir 908 by, for example, 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 that can 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. Therefore, the filling adapter 1000 can reduce the dexterity and aiming required to properly insert the needle through the partition of the disposable housing assembly 804 for the purpose of filling the reservoir 908.

[0199] As discussed above, the disposable housing assembly 804 may be configured to facilitate control of the amount of injectable fluid delivered to the reservoir 908 during filling. For example, the membrane assembly 902 of the disposable housing assembly 804 may include ribs 964, 966, 968 that can be pressed and displaced at least partially into the reservoir 908, thereby reducing the volume of the reservoir 908. Thus, when the injectable fluid is delivered to the reservoir 908, the volume of fluid that can be contained by the reservoir 908 may be reduced accordingly. The ribs 964, 966, 968 may be accessible through openings 958, 960, 962 in the upper portion 904 of the disposable housing assembly 804.

[0200] 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 releasably engaged with the disposable housing assembly 804, the buttons 1014, 1016, 1018 may be aligned with ribs 964, 966, 968. The button assemblies 1014, 1016, 1018 may be, for example, cantilever members that can be pressed. When the filling adapter 1000 is releasably engaged with the disposable housing assembly 804, one or more of the button assemblies 1014, 1016, 1018 may be pressed, which may cause one of each of the ribs 964, 966, 968 into the reservoir 908, resulting in an accompanying reduction in the volume of the reservoir 908.

[0201] For example, for illustrative purposes, assume that reservoir 908 has a maximum capacity of 3.00 mL. Furthermore, assume that button assembly 1014 is configured to displace rib 964 into disposable housing assembly 804, resulting in a 0.5 mL reduction of the 3.00 mL capacity of disposable housing assembly 804. Furthermore, assume that button assembly 1016 is configured to displace rib 966 into disposable housing assembly 804, similarly resulting in a 0.5 mL reduction of the 3.00 mL capacity of disposable housing assembly 804. Furthermore, assume that button assembly 1018 is configured to displace slot assembly 968 into disposable housing assembly 804, similarly resulting in a 0.5 mL reduction of the 3.00 mL capacity of disposable housing assembly 804. Therefore, if the user desires to fill the reservoir 908 in the disposable housing assembly 804 with 2.00 mL of injectable fluid, in some embodiments the user may first fill the reservoir to a volume of 3.00 mL and then press the button assemblies 1016 and 1014 (resulting in the displacement of the rib 966 into the disposable housing assembly 804) to effectively reduce the volume of the reservoir 908 in the disposable housing assembly 804 from 3.00 mL to 2.00 mL. In some embodiments, the user may first press each of the corresponding number of button assemblies to effectively reduce the capacity of the reservoir 908, and then refill the reservoir 908. While a specific number of button assemblies are shown to illustrate an exemplary embodiment, in other embodiments, the number of button assemblies may vary from a minimum of one to as many as desired. In addition, 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. Furthermore, in various embodiments, the reservoir may contain a larger or smaller volume than that described in the exemplary embodiment.

[0202] According to the above configuration, button assemblies (e.g., button assemblies 1014, 1016, 108) may be used, at least in part, to control the filling volume of the reservoir 908. The maximum filling volume of the reservoir 908 may be achieved by not pressing any of the button assemblies. A second maximum filling volume may be achieved by pressing one button assembly (e.g., button assembly 1014). A third maximum filling volume may be achieved by pressing two button assemblies (e.g., button assemblies 1014, 1016). A minimum filling volume may be achieved by pressing all three button assemblies (e.g., button assemblies 1014, 1016, 1018).

[0203] Furthermore, in embodiments, button assemblies 1014, 1016, and 1018 may be used, at least partially, to facilitate the filling of the reservoir 908. For example, once a filling needle (which may be fluid-connected to, for example, a vial of injectable fluid) is inserted into the reservoir 908, button assemblies 1014, 1016, and 1018 may be pressed to deliver at least a portion of the air that may be contained in the reservoir into the vial of injectable fluid. The button assemblies 1014, 1016, and 1018 may then be released to allow the injectable fluid to flow from the vial into the reservoir 908. Once reservoir 908 is filled with injectable fluid, one or more button assemblies (e.g., one or more of button assemblies 1014, 1016, 1018) may be pressed, thereby pushing out at least a portion of the injectable fluid from reservoir 908 (e.g., via a needle used to fill reservoir 908 and return it to the vial of injectable fluid). As discussed above, the volume of injectable fluid contained in reservoir 908 may be controlled, for example, depending on how many button assemblies are pressed (e.g., how much injectable fluid is pushed back into the vial of injectable fluid).

[0204] Referring particularly to Figures 62-64, the filling assist 1010 may be pivotably connected to the filling adapter substrate 1020. For example, the filling assist 1010 may include pivot members 1022, 1024, which may be configured to be received within pivot support members 1026, 1028, thereby allowing the filling assist to pivot between an open position (e.g., as shown in Figures 57-61) and a closed position (e.g., as shown in Figures 63-64). The closed position may be suitable, for example, for packaging the filling adapter 1000, storing the filling adapter 1000, or the equivalent. To ensure that the filling assist 1010 is properly oriented for filling the reservoir 908, the filling adapter 1000 may include a support member 1030. To properly orient the filling assist 1010, the user may pivot the filling assist 1010 to a fully open position, in which case the filling assist 1010 may come into contact with the support member 1030.

[0205] According to an alternative embodiment, also with reference to Figure 65, the filling adapter 1050 may be configured to releasably engage with the disposable housing assembly 804 via a plurality of locking tabs (e.g., locking tabs 1052, 1054). In addition, the filling adapter 1050 may include a plurality of button assemblies (e.g., button assemblies 1056, 1058, 1060) that 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 partition wall of the disposable housing 804 for accessing the reservoir 908, for example, for the purpose of filling 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 adhesive, heat fusion, compression fitting, or equivalent.

[0206] See also Figure 66-74, the vial filling adapter 1100 may be configured to facilitate filling the reservoir 908 of the disposable housing assembly 804 directly from the vial. Similar to the filling adapter 1000, the vial filling adapter 1100 may include locking tabs 1102, 1104, 1106, and 1108 which may be configured to engage with the radial tabs 934, 936, 938, and 940 of the disposable housing assembly, substantially the same as the tabs 942, 944, 946, and 948 of the locking ring assembly 806. Therefore, the vial filling adapter 1100 may be releasably engaged with the disposable housing assembly 804 by 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, thereby releasably engaging the locking tabs 1102, 1104, 1106, and 1108 with the radial tabs 934, 936, 938, and 940.

[0207] As discussed above, the disposable housing assembly 804 may be configured to facilitate control of the amount of injectable fluid delivered to the reservoir 908 during filling. For example, the membrane assembly 902 of the disposable housing assembly 804 may include ribs 964, 966, 968 that can be pressed and displaced at least partially into the reservoir 908, thereby reducing the volume of the reservoir 908. Thus, when the injectable fluid is delivered to the reservoir 908, the volume of fluid that can be contained by the reservoir 908 may be reduced accordingly. The ribs 964, 966, 968 may be accessible through openings 958, 960, 962 in the upper portion 904 of the disposable housing assembly 804.

[0208] The vial filling adapter 1100 may include one or more button assemblies (e.g., button assemblies 1110, 1112, 1114) corresponding to the ribs 964, 966, 968 (as shown in Figure 52A). That is, when the vial filling adapter 1100 is releasably engaged with the disposable housing assembly 804, the buttons 1110, 1112, 1114 may be aligned with the ribs 964, 966, 968. The button assemblies 1110, 1112, 1114 may be, for example, cantilever members that can be pressed. When the vial filling adapter 1100 is releasably engaged with the disposable housing assembly 804, one or more of the button assemblies 1110, 1112, 1114 may be pressed, in which case one of the ribs 964, 966, and 698 may be displaced into the reservoir 908, thereby reducing the volume of the reservoir 908.

[0209] For example, for illustrative purposes, assume that reservoir 908 has a maximum capacity of 3.00 mL. Furthermore, assume that button assembly 1110 is configured to displace rib 964 into disposable housing assembly 804, resulting in a 0.5 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Furthermore, assume that button assembly 1112 is configured to displace rib 966 into disposable housing assembly 804, similarly resulting in a 0.5 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Furthermore, assume that button assembly 1114 is configured to displace rib 968 into disposable housing assembly 804, similarly resulting in a 0.5 mL reduction in the 3.00 mL capacity of disposable housing assembly 804. Therefore, if the user wishes to fill the reservoir 908 in the disposable housing assembly 804 with 2.00 mL of injectable fluid, the button assemblies 1112 and 1114 can be pressed (resulting in the displacement of the ribs 966 and 968 into the disposable housing assembly 804) to effectively reduce the 3.00 mL capacity of the reservoir 908 in the disposable housing assembly 804 to 2.00 mL.

[0210] The vial filling adapter 1100 may further include a vial filling auxiliary assembly 1116, which can be configured to fluidly connect a vial of injectable fluid to a reservoir 908 of a disposable housing assembly 804 via a partition. Referring particularly to Figure 71, the vial filling auxiliary assembly may include a double-ended needle assembly 1118. The double-ended needle assembly 1118 may include a first needle end 1120 configured to penetrate a partition of a vial (not shown) and a second needle end 1122 configured to penetrate a partition of a disposable housing assembly 804. Thus, the vial and reservoir 908 may be fluidly connected, allowing the injectable fluid to be transferred from the vial to the reservoir 908. The double-ended needle assembly 1118 may include a vial engaging portion 1124 adjacent to the first end 1120. The vial engaging arms 1124, 1126 may be configured to releasably engage with, for example, the vial cap to help maintain a fluid connection between the double-ended needle assembly 1118 and the vial. In addition, the double-ended needle assembly 1118 may include a body 1128 which can be slidably received in the opening 1130 of the vial filling assist body 1132. The vial filling assist body 1132 may include stabilizer arms 1134, 1136 which can be configured 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 can penetrate the partition wall of the vial, and the vial cap may be engaged by the engaging arms 1124, 1126. The body 1128 may be slidably inserted into the opening 1130 such that the second end 1122 of the double-ended needle assembly 1118 can penetrate the partition wall of the disposable housing assembly 804.

[0211] Similar to the filling adapter 1000, the vial filling assist assembly 1116 may be configured to be pivotably connected to the vial filling adapter substrate 1138. For example, the vial filling assist 1116 may include pivot members 1140, 1142, which may be configured to be received in pivot support members 1144, 1146 (shown, for example, in Figure 71), thereby allowing the vial filling assist 1116 to pivot between an open position (for example, as shown in Figures 66-70) and a closed position (for example, as shown in Figures 72-74). The closed position may be suitable for, for example, packaging of the vial filling adapter 1100, housing of the vial filling adapter 1100, or the equivalent. To ensure that the vial filling assist 1116 is properly oriented for filling the reservoir 908, the vial filling adapter 1100 may include a support member 1148. 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 come into contact with the support member 1148. In addition, the vial filling adapter substrate 1138 may include one or more locking features (e.g., locking tabs 1150, 1152) that can engage with 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 (e.g., tabs 1154, 1156) that can be configured to assist in holding the double-ended needle assembly 1118 by, for example, preventing the double-ended needle assembly 1118 from the vial filling assist body 1132.

[0212] As shown in Figures 72-74, the filling assist assembly 1116 is in the closed position. In this configuration, the support member 1148 may also function as a needle guard. When removing the filling assist assembly 1116 from the disposable housing assembly 804, the support member 1148 may function to allow the user to firmly grasp the end and rotate the filling assist assembly 1116 for removal. As shown in Figure 70, in the open position, the support member 1148 may function as a stopper to maintain proper orientation.

[0213] Referring again to Figures 57-73, an exemplary embodiment of the filling adapter includes a gripping feature (e.g., 1166 in Figure 72). The gripping feature 1166 may provide a gripping interface for removing the filling adapter from the disposable housing assembly 804. Although one configuration is shown in these figures, the configuration may differ in other embodiments. Yet another embodiment may not include a gripping feature.

[0214] According to one embodiment, the filling adapter substrate 1020 and the vial filling adapter substrate 1138 may be interchangeable components. Therefore, a single substrate (for example, either the filling adapter substrate 1020 or the vial filling adapter substrate 1138) may be used 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.

[0215] Various embodiments of the filling adapter may offer many safety benefits, including, but are not limited to, providing a system for filling a reservoir without handling a needle, protecting the reservoir from damage to its integrity through unintentional contact with a needle, i.e., unintentional puncture, and being designed to allow both hands to be used. In some embodiments, a system for maintaining air in the reservoir may also be provided.

[0216] As discussed above, the reusable housing assembly 802 may include a battery 832, which may include, for example, a rechargeable battery. See also Figures 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, which are generally configured to be electrically connected 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 equivalents. In addition, the top plate 1204 may include matching tabs 1208, 1210, which may be configured to mesh with openings 836, 838 of the substrate 818 of the reusable housing assembly 802 (as shown, for example, in Figure 35C). The cooperation of the alignment tabs 1208, 1210 and the openings 836, 838 ensures that the reusable housing assembly 802 can be aligned with the battery charger 1200 so that the electrical contact 1206 of the battery charger 1200 can be electrically connected to the electrical contact 834 of the reusable housing assembly 802.

[0217] See also Figures 77 and 78, the battery charger 1200 may be configured to releasably engage with the reusable housing assembly 802. For example, like the disposable housing assembly 804, the battery charger 1200 may include one or more locking tabs (e.g., locking tabs 1212, 1214 shown in Figure 76). The locking tabs (e.g., locking tabs 1212, 1214) may be engaged by tabs 942, 944, 946, 948 of the locking ring assembly 806. Thus, the reusable housing assembly 802 may be aligned with the battery charger 1200 (via alignment tabs 1208, 1210) with the locking ring 806 in a first unlocked position, as shown in Figure 77. The locking ring 806 may be rotated relative to the battery charger 1200 in the direction of arrow 1216, as shown in Figure 78, so that the tabs 942, 944, 946, and 948 of the locking ring 806 are releasably engaged with the locking tabs of the battery charger 1200 (e.g., locking tabs 1212 and 1214).

[0218] In some embodiments, the battery charger 1200 may include a recessed area 1218, for example, in an exemplary embodiment, which can provide a gap to accommodate the pump and valve components of the reusable housing assembly 802. Referring also to Figures 79 and 80, the battery charger 1200 may supply current to the electrical contact 1206 (and thereby to the reusable housing assembly 802 via the electrical contact 834) to recharge the battery 832 of the reusable housing assembly 802. In some embodiments, current may not be supplied to the electrical contact 1206 when no signal indicating a fully engaged reusable housing is provided. According to such embodiments, the risks associated with short circuits (e.g., due to foreign matter in contact with the electrical contact 1206) and damage to the reusable housing assembly 802 (e.g., due to improper initial alignment between the electrical contact 1206 and the electrical contact 834) can be reduced. In addition, the battery charger 1200 may not unnecessarily draw current when the battery charger is not charging the reusable housing assembly 802.

[0219] Still referring to Figures 79 and 80, the battery charger 1200 may include a lower housing portion 1224 and a top plate 1204. The printed circuit board 1222 (which may include, for example, electrical contacts 1206) may be located in a cavity between the top plate 1204 and the lower housing portion 1224.

[0220] See also Figures 81-89, which illustrate various embodiments of the battery charger / docking station. Figures 81 and 82 depict a desktop charger 1250 including a recess 1252 configured to mesh with and recharge a reusable housing assembly (e.g., reusable housing assembly 802). The reusable housing assembly may rest in the recess 1252 and / or be releasably engaged in the recess 1252, as discussed above. In addition, the desktop charger 1250 may include a recess 1254 configured to mesh with a remote control assembly (e.g., remote control assembly 300). The recess 1254 may include a USB plug 1256, which may be configured to connect with the remote control assembly when the remote control assembly is placed in the recess 1254. The USB plug 1256 may enable data transfer to and from the remote control assembly, as well as charging of the remote control assembly. The desktop charger 1250 may also include a USB port 1258 (which may include, for example, a mini USB port) to enable the desktop charger to receive power (for example, to charge the reusable enclosure assembly and / or remote control assembly). In addition / alternatively, the USB port 1258 may be configured for data transfer to and from the remote control assembly and / or reusable enclosure assembly, for example, by connection to a computer (not shown).

[0221] Referring to Figures 83A-83B, as in previous embodiments, the desktop charger 1260 may include a recess 1262 for engaging with a reusable housing assembly (e.g., reusable housing assembly 1264). The desktop charger may also include a recess 1266 configured to receive a remote control assembly (e.g., remote control assembly 1268). One or more of the recesses 1262, 1266 may each include electrical and / or data connections configured to charge the reusable housing assembly 1262 and / or the remote control assembly 1268, and / or transfer data to and from there.

[0222] Referring to Figures 84A-84B, another embodiment of the desktop charger is shown. Similar to desktop charger 1260, desktop charger 1270 may include recesses (not shown) for engaging with the reusable housing assembly 1272 and the remote control assembly 1274, respectively. As shown, desktop charger 1270 may carry the reusable housing assembly 1272 and the remote control assembly 1274 in a parallel configuration. Desktop charger 1270 may include various electrical and data connections configured to charge the reusable housing assembly 1272 and / or the remote control assembly 1274, and / or transfer data thereto and therefrom, as described in the various embodiments above.

[0223] Referring to Figures 85A-85D, the crushable charger 1280 may include a recess 1282 for receiving the reusable housing assembly 1284 and the remote control assembly 1286. The crushable charger 1280 may include various electrical and data connections configured to charge the reusable housing assembly 1284 and / or the remote control assembly 1286, and / or transfer data thereto and therefrom, as described in the various embodiments above. In addition, as shown in Figures 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 Figure 85B) in which 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 Figure 85D) in which the recess 1282 can be covered by the pivotable cover 1288. In the closed position, the recess 1282, as well as any electrical and / or data connections located within it, can be protected from damage.

[0224] Referring to Figure 86, the wall charger 1290 may include a recess 1292 configured to receive a reusable housing assembly 1294. In addition, the wall charger 1290 may include a recess 1296 configured to receive a remote control assembly 1298. The reusable housing assembly 1294 and the remote control assembly 1298 may be positioned 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 allow 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. In addition, while plugged into an electrical outlet, the wall charger 1290 may be supplied with power to charge the reusable housing assembly 1294 and / or the remote control assembly 1298.

[0225] Referring to Figure 87, the wall charger 1300 may include a recess 1302 configured to receive a remote control assembly 1304. In addition, the wall charger may include a recess (not shown) configured to receive a reusable housing assembly 1306. The wall charger 1300 may be configured to position the remote control assembly 1304 and the reusable housing assembly 1306 in an antiparallel configuration, which may provide a relatively thin profile. In addition, the wall charger 1300 may include an electrical plug 1308 configured to be plugged into an electrical outlet. The electrical plug 1308 may include a retractable configuration, which may allow the electrical plug 1308 to pivot between an extended position (e.g., as shown) and a retracted position. In the extended 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 located in a recess 1310, which may protect the electrical plug 1308 from damage and / or damage to other items.

[0226] Referring to Figure 88, the charger 1320 may include a recess 1322 configured to receive a reusable housing assembly 1324. The charger 1320 may also include a recess (not shown) configured to receive a remote control assembly 1326. The charger 1320 may also include a cover 1328. The cover 1328 may be configured to pivot between an open position (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 (for example, allowing a user to remove the reusable housing assembly 1324 and / or the remote control assembly 1326 from / install them in 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 any electrical and / or data connections associated with the reusable housing assembly 1324, the remote control assembly 1326, and / or the charger 1320.

[0227] Referring to Figures 89A-89B, the wall charger 1350 may include a recess 1352 configured to receive a remote control assembly 1354. The wall charger 1350 may also include a recess 1356 configured to receive a reusable housing assembly 1358. The wall charger 1350 may be configured to position the remote control assembly 1354 and the reusable housing assembly 1358 in substantially parallel configuration, thereby providing a relatively thin profile. The charger 1350 may also include an electrical plug 1360, which may be configured to plug into an electrical outlet, for example. The electrical plug 1360 may include a retractable configuration, which may allow the electrical plug 1360 to pivot between an extended position (e.g., as shown) and a retracted position. In the extended position, the electrical plug 1360 may be oriented to plug into an electrical outlet. In the storage position, the electrical plug 1360 may be positioned within a recess 1362 that can protect the electrical plug 1308 from damage and / or damage to other items.

[0228] Infusion pump therapy may include volume and time specifications. The amount of fluid dispensed, along with the dispensing timing, can be two important factors of infusion pump therapy. As will be discussed in detail below, the infusion pump devices and systems described herein may provide a method of dispensing fluid, along with devices, systems, and methods for measuring the amount of fluid dispensed. However, in situations where the calibration and accuracy of the measuring device are important, there may be an advantage in determining any decrease in the accuracy of the measuring device as quickly as possible. Thus, there is an advantage to off-board verification of volume and dispensing.

[0229] As discussed above, the injection pump assembly 100 may include a volume sensor assembly 148 configured to monitor the amount of fluid injected by the injection pump assembly 100. Furthermore, as discussed above, the injection pump assembly 100 may be configured such that the volume measurement produced by the volume sensor assembly 148 can be used through a feedback loop to control the amount of injectable fluid injected to the user.

[0230] See also Figures 90A-90C, which show one line drawing and two cross-sectional views of the volume sensor assembly 148. See also Figures 91A-91I, which show various isometric and line drawings of the volume sensor assembly 148 (shown to include the upper housing 1400). See also Figures 92A-92I, which show various isometric and line drawings of the volume sensor assembly 148 (with the upper housing 1400 removed), with the speaker assembly 622, reference microphone 626, and printed circuit board assembly 830 exposed. See also Figure 93A-93I, which shows various isometric and line cross-sectional views of the volume sensor assembly 148 (with the printed circuit board assembly 830 removed), with the port assembly 624 exposed. See also Figure 94A-94F, which shows various isometric and line cross-sectional views of the volume sensor assembly 148 (with the printed circuit board assembly 830 removed), with the port assembly 624 exposed. See also Figure 95, which shows an exploded view of the volume sensor assembly 148, exposing the upper housing 1400, speaker assembly 622, reference microphone 626, seal assembly 1404, lower housing 1402, port assembly 624, spring diaphragm 628, and retaining ring assembly 1406.

[0231] The following discussion concerns the design and operation of volume sensor assembly 148 (shown in a simplified form in Figure 96). The following terms may be used in the following discussion.

[0232] [Table 5]

[0233] Derivation of the equation for volume sensor assembly 148: Modeling of acoustic volume The pressure and volume of an ideal adiabatic gas can be related by the following:

[0234]

number

[0235] In the formula, K is a constant defined by the initial conditions of the system. Equation 1 can be described as follows, with respect to the mean pressure P and volume V, and in addition to these pressures, small time-dependent disturbances p(t) and v(t).

[0236]

number

[0237] By differentiating this equation, the following equation can be obtained.

[0238]

number

[0239] This can be simplified to the following formula.

[0240]

number

[0241] When the sound pressure level is much lower than atmospheric pressure, the equation can be further simplified to the following:

[0242]

number

[0243] The validity of this assumption can be demonstrated using the adiabatic relation as follows:

[0244]

number

[0245] Therefore, the error in the assumption is as follows:

[0246]

number

[0247] A very large acoustic signal (120 dB) can correspond to a pressure sine wave with an amplitude of approximately 20 Pascals. Assuming atmospheric conditions (γ=1.4, P=101325 Pa), the resulting error is 0.03%. The conversion from dB to Pa is as follows:

[0248]

number

[0249] By applying the law of ideal gases P=ρRT and substituting it for pressure, the following equation can be obtained.

[0250]

number

[0251] Equation 9 is as follows:

[0252]

number

[0253] It can be described in relation to this.

[0254]

number

[0255] The acoustic impedance with respect to volume can be defined as follows:

[0256]

number

[0257] Acoustic port modeling An acoustic port can be modeled by assuming that all the fluid within the port essentially moves as a rigid cylinder reciprocates axially. It is assumed that all the fluid in the channel moves at the same velocity, that the channel has a constant cross-section, and that "end effects" caused by fluid entering and exiting the channel are ignored. formula

[0258]

number

[0259] Assuming laminar friction, the frictional force acting on the mass of fluid in the channel can be described as follows:

[0260]

number

[0261] Next, a second-order differential equation can be used to describe the dynamics of the fluid within the channel.

[0262]

number

[0263] Alternatively, regarding volumetric flow rates, they are as follows:

[0264]

number

[0265] Next, the acoustic impedance of the channel can be described as follows:

[0266]

number

[0267] System Transfer Function Using the volume and port dynamics defined above, the volume sensor assembly 148 can be represented by the following system of equations: (k = speaker, r = resonator)

[0268]

number

[0269]

number

[0270]

number

[0271]

number

[0272] p0

[0273]

number

[0274] When treated as input to be substituted, one equation may be eliminated.

[0275]

number

[0276]

number

[0277]

number

[0278] Intersystem transfer function The relationship between speaker volume and variable volume can be called the system transfer function. This transfer function can be derived from the above equation and is as follows:

[0279]

number

[0280] During the ceremony,

[0281]

number

[0282] See also Figure 97, which shows the Bode plot of Equation 23.

[0283] The difficulty with this relationship is that the complex poles depend on the variable volume V2 and the reference volume V1. Any change in the average position of the speaker can lead to errors in the estimated volume.

[0284] Port-to-port transfer function The relationship between the two volumes on either side of an acoustic port can be called the port-to-port transfer function. This relationship is as follows:

[0285]

number

[0286] This is shown in the graph in Figure 98.

[0287] This relationship has the advantage that the poles depend only on the variable volume and not on the reference volume. However, it has the drawback that the resonance peak is actually due to a zero inversion in response to the reference volume pressure. Therefore, the pressure measurements in the reference chamber will have a low amplitude near the resonance, which will potentially increase the noise of the measurements.

[0288] Speaker-to-speaker transfer function Pressure can also be measured on both sides of the speaker. This is called the speaker-to-speaker transfer function.

[0289]

number

[0290] This is shown in the graph in Figure 99.

[0291] This transfer function includes a set of complex poles in addition to a set of complex zeros.

[0292] When we look at the limit of this transfer function,

[0293]

number

[0294] And,

[0295]

number

[0296] That is the case.

[0297] Resonance quality coefficient and peak response The quality of resonance is the ratio of stored energy to the power loss increased by the resonant frequency. For purely secondary systems, the quality factor can be expressed as a function of the damping ratio.

[0298]

number

[0299] The ratio of the peak response to low-frequency resonance can also be described as a function of the damping ratio.

[0300]

number

[0301] This can occur at the natural decay frequency.

[0302]

number

[0303] 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 port may be as follows:

[0304]

number

[0305] At a 90° phase point,

[0306]

number

[0307] That is the case.

[0308] The resonant frequency can be determined on a physical system using several methods. A phase-locked loop may be employed to find the 90° phase point, where this frequency may correspond to the system's natural frequency. Alternatively, the resonant frequency may be calculated using the phases at any two frequencies.

[0309] The phase φ at a given frequency satisfies the following relationship.

[0310]

number

[0311] That is the case.

[0312] The value of V2 yields the following equation.

[0313]

number

[0314] Therefore, to calculate the system's natural frequency, the phase ratio at two different frequencies, ω1 and ω2, can be used.

[0315]

number

[0316] For computational efficiency, it is not necessary to actually calculate the phase. The ratio of the real and imaginary parts of the response (tanφ) is sufficient.

[0317] Rewriting equation 33 in terms of variable volume yields the following equation.

[0318]

number

[0319] Volume estimation using a swept sine wave The resonant frequency of the system can be estimated using swept sinusoidal system identification. This method allows the system's response to sinusoidal pressure fluctuations to be determined at a number of different frequencies. This frequency response data can then be used to estimate the system transfer function using linear regression.

[0320] The transfer function of a system can be expressed as a rational function of s. The general case is expressed below for a transfer function with an n-th order numerator and an m-th order denominator, where N and D are the coefficients of the numerator and denominator, respectively. The equation is normalized such that the principal coefficient of the denominator is 1.

[0321]

number

[0322] or

[0323]

number

[0324] This equation can be rewritten as follows:

[0325]

number

[0326] When this sum is expressed in matrix notation, it yields the following:

[0327]

number

[0328] In the equation, k is the number of data points collected in the swept sine wave. For simplicity of notation, this equation can be summarized using vectors.

[0329]

number

[0330] In the equation, y is k × 1, x is k × (m + n - 1), and c is (m + n - 1) × 1. The coefficients can then be found using the least squares method. The error function can be written as follows:

[0331]

number

[0332] The function to be minimized is the weighted square of the error function. W is a k × k diagonal matrix.

[0333]

number

[0334]

number

[0335] Since the two middle terms are scalars, the transpose can be ignored.

[0336]

number

[0337]

number

[0338]

number

[0339] In all of these cases, it may be necessary to use the complex transpose. Although this method may yield complex coefficients, the process may be modified to ensure that all coefficients are real. Least squares minimization may be modified to yield only real coefficients if the error function is changed to the following equation.

[0340]

number

[0341] Therefore, the coefficient can be determined by the following relationship.

[0342]

number

[0343] Solution of a quadratic system For systems with a zero-order numerator and a second-order denominator, as shown by the transfer function, the following applies:

[0344]

number

[0345]

number

[0346] During the ceremony,

[0347]

number

[0348] To simplify the algorithm, some of the terms can be combined.

[0349]

number

[0350] During the ceremony,

[0351]

number

[0352]

number

[0353] To derive 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.

[0354]

number

[0355] Next, the real and imaginary parts of the above expression D can be as follows:

[0356]

number

[0357]

number

[0358] By combining these terms, we obtain the final formula for the D matrix, which can contain only real values.

[0359]

number

[0360] The same method can be used to find the equation of vector b with respect to G and ω. The real and imaginary parts of y are as follows:

[0361]

number

[0362] By combining the real and imaginary parts, we obtain the following expression for vector b.

[0363]

number

[0364] The next step is to invert matrix D. Since the matrix is ​​symmetric and positive definite, the number of calculations required to find its reciprocal will be reduced compared to the general 3x3 case. The general formula for the inverse matrix is ​​as follows:

[0365]

number

[0366] If D is expressed as follows,

[0367]

number

[0368] The adjoint matrix can be written as follows:

[0369]

number

[0370] Due to symmetry, it may be necessary to compute only the upper diagonal matrix. Then, using the zero element in the original array, the determinant of the adjoint matrix can be computed.

[0371]

number

[0372] Ultimately, the reciprocal of D can be written as follows:

[0373]

number

[0374] Since we are trying to solve the following equation,

[0375]

number

[0376] Next,

[0377]

number

[0378] The final step is to obtain a quantitative assessment of how well the data fits the model. Therefore, the original formula for the error is as follows:

[0379]

number

[0380] This can be expressed as follows with respect to matrix D, as well as vectors b and c:

[0381]

number

[0382] During the ceremony,

[0383]

number

[0384]

number

[0385] Model fit errors can also be used to detect sensor failures.

[0386] Alternative solutions for quadratic systems

[0387]

number

[0388] or

[0389]

number

[0390] This equation can be rewritten as follows:

[0391]

number

[0392] Applying this sum to matrix notation yields the following:

[0393]

number

[0394] For systems with a zero-order numerator and a second-order denominator, as shown by the transfer function,

[0395]

number

[0396] The coefficients of this transfer function can be determined based on the equations found in the previous section.

[0397]

number

[0398] During the ceremony,

[0399]

number

[0400] To simplify the algorithm, several terms can be combined.

[0401]

number

[0402] During the ceremony,

[0403]

number

[0404]

number

[0405] To derive the equation for D with respect to the complex response vector G and the natural frequency s=jω, the partition X can be divided into its real and imaginary parts.

[0406]

number

[0407]

number

[0408] Next, the real and imaginary parts of the above expression D can be as follows:

[0409]

number

[0410]

number

[0411] By combining these terms, we obtain the final formula for the D matrix, which can contain only real values.

[0412]

number

[0413] The same method can be used to find the equation of vector b with respect to G and ω. The real and imaginary parts of y are as follows:

[0414]

number

[0415] By combining the real and imaginary parts, we obtain the following expression for vector b.

[0416]

number

[0417] Implementation of acoustic volume sensing Collection of frequency response data and collection of complex response data To implement the volume sensor assembly 148, it should determine the relative responses of the reference microphone 626 and the invariant volume microphone 630 to a sound wave set by the speaker assembly 622. This may be achieved by driving the speaker assembly 622 with a sinusoidal output at a known frequency. The complex responses of microphones 626 and 630 may then be found at their driving frequency. Finally, the relative responses of microphones 626 and 630 are found and may be corrected for alternating sampling, for example, by an analog-to-digital converter (i.e., ADC).

[0418] In addition, the total signal variance may be calculated and compared to the variance of a pure tone extracted using a discrete Fourier transform (i.e., DFT). This can provide a measure of how much of the signal power originates from noise sources or distortion. This value may then be used to reject and repeat poor measurements.

[0419] Calculation of Discrete Fourier Transform The signal from the microphone may be sampled in sync with the output to the speaker assembly 622, such that a fixed number of points N are taken for each wavelength. The measured signal at each point of the wavelength may be summed over an integer number of wavelengths M and stored by the ISR in array x for processing after all data for that frequency has been collected. The DFT may be performed on the data at integer values ​​corresponding to the speaker's driving frequency. The general formula for the first harmonic of the DFT is as follows:

[0420]

number

[0421] The product MN may be the total number of points, and the factor 2 can be added such that the real and imaginary parts resulting from the solution match the amplitude of the sine wave.

[0422]

number

[0423] The real part of this expression can be as follows:

[0424]

number

[0425] To reduce the number of calculations required to compute the DFT, the symmetry of the cosine function may be used. The above equation may be equivalent to the following equation.

[0426]

number

[0427] Similarly, for the imaginary part of the equation,

[0428]

number

[0429] This can be expressed as follows:

[0430]

number

[0431] The variance of this signal can be calculated as follows:

[0432]

number

[0433] The maximum possible value of the real and imaginary parts of x is 2 11 This may also be the case, and this corresponds to half of the AD range. The maximum value of the sound dispersion is half the square of the AD range, 2 21 It is possible.

[0434] Calculation of signal dispersion The pseudo-dispersion of a signal can be calculated using the following relationship:

[0435]

number

[0436] The results may be expressed in units of the square of the AD count. This may be merely a "pseudovariance" because the signal is averaged over M periods before the variance is calculated over N samples in the "average" period. However, this can be a useful metric for determining whether the "average" signal looks sinusoidal at the expected frequency. This may be done by comparing the total signal variance with the sine wave variance found in the discrete Fourier transform.

[0437] The sum is approximately for a 12-bit ADC.

[0438]

number

[0439] It may also be N<2 7 =128, and M<2 6If = 64, the sum is 2 43 It will be less than and may be stored as a 64-bit integer. The maximum possible value of the variance is 0 to 2 for each consecutive sample if the ADC oscillates. 12 This can result in a value of this.

[0440]

number

[0441] This can result in a peak variance, and the result is up to 1 / 2 9 The resolution may be stored in a signed 32-bit integer.

[0442] Calculation of relative microphone response The relative response (G) of microphones 626 and 630 can be calculated from the complex response of each individual microphone.

[0443]

number

[0444]

number

[0445]

number

[0446] The denominator of either of the formulas can be expressed in terms of the reference tone variance calculated in the previous section, as follows:

[0447]

number

[0448] A / D skew correction The signals from microphones 626 and 630 do not need to be sampled simultaneously. The A / DISR obtains a total of N samples for each wavelength of microphone 626 and 630, and then switches between microphones 626 and 630. The result is:

[0449]

number

[0450] This could be a phase offset between the two microphones 626 and 630. To compensate for this phase offset, complex rotation can be applied to the relative frequency response calculated in the previous section.

[0451]

number

[0452] 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 resonant port (e.g., port 1504, Figure 100) connected to an external volume (e.g., external volume 1506, Figure 100).

[0453] The following simultaneous equations may represent a 3-chamber configuration.

[0454]

number

[0455]

number

[0456]

number

[0457]

number

[0458]

number

[0459] By applying these equations to the state space, we obtain the following equation.

[0460]

number

[0461] The frequency response can be represented graphically in the Bode plot shown in Figure 101, or it can be described in the form of a transfer function.

[0462]

number

[0463] By expanding the denominator, we obtain the following equation.

[0464]

number

[0465] The bubbles beneath the diaphragm material in a variable volume will follow the same dynamic equations as the leakage path. In this case, the diaphragm material may act as a resonant mass rather than a leakage port. Therefore, the equations may be as follows:

[0466]

number

[0467] In the formula, m is the mass of the diaphragm, A is the cross-sectional area of ​​the diaphragm that can resonate, and bm is mechanical attenuation. Equation 106 can be described in terms of the volumetric flow rate.

[0468]

Number

[0469] where the volume of the bubble is V3. When the bubble volume is substantially smaller than the acoustic volume, V3 << V2, the transfer function can be simplified to the following equation.

[0470]

Number

[0471] Second-order with time delay The equation of the volume sensor assembly 148 derived above assumes that the pressure is the same anywhere in the acoustic volume. This is only an approximate equation because of the time delay associated with the propagation of the sound wave through the volume. This situation can appear as a time delay or time advance based on the relative positions of the microphone and the speaker. The time delay can be represented in the Laplace domain as follows.

[0472]

Number

[0473] This results in a system of non-linear equations. However, a first-order Padé approximation of the time delay can be used as follows.

[0474]

Number

[0475] This is shown graphically in FIG. 102.

[0476] Three-chamber volume estimation The volume sensor assembly 148 may also be configured using a third reference volume (e.g., reference volume 1508, Figure 103) connected to a separate resonant port (e.g., port 1510, Figure 103). This configuration may enable temperature-independent volume estimation. The following simultaneous equations may represent a 3-chamber configuration.

[0477]

number

[0478]

number

[0479]

number

[0480]

number

[0481]

number

[0482] Using these equations and determining the transfer function values ​​across each resonant port, we obtain the following equation:

[0483]

number

[0484] During the ceremony,

[0485]

number

[0486]

number

[0487] During the ceremony,

[0488]

number

[0489] The volume of the volume sensor chamber 620 can be estimated using the ratio of the natural frequencies of the two resonant ports, as follows:

[0490]

number

[0491] Equation 120 illustrates that the volume of the volume sensor chamber 620 may be proportional to the reference volume 1508. The ratio of these two volumes (in the ideal model) may depend only on the geometry of the resonant port (e.g., port 1510, Figure 103) and not on temperature.

[0492] Exponential volume model Assume that the outflow through the flow resistance takes the following form:

[0493]

number

[0494] 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.

[0495]

number

[0496] This leads to the following solution, assuming a zero initial volume.

[0497]

number

[0498] Therefore, the output flow velocity flows as follows.

[0499]

number

[0500] The volume delivered during the pump phase can be described as follows:

[0501]

number

[0502] Device calibration Model fitting allows the port's resonant frequency to be extracted from sinusoidal 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:

[0503]

number

[0504] Since the speed of sound will vary with temperature, it may be useful to separate the temperature effect.

[0505]

number

[0506] The volume can then be expressed as a function of the measured resonant frequency and temperature.

[0507]

number

[0508] In the formula, c is the calibration constant.

[0509]

number

[0510] That is the case.

[0511] Implementation details End-point effects The air resonating within a port (e.g., port assembly 624) may 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 equations. 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.

[0512]

number

[0513] Assuming the following values,

[0514]

number

[0515]

number

[0516]

number

[0517]

number

[0518]

number

[0519] Therefore, the air extends approximately 1.9 mm into the acoustic chamber.

[0520] The fixed size of V1 (i.e., fixed volume) relative to V2 (i.e., variable volume)

[0521] The fixed size of V1 (e.g., fixed volume 1500) may require a trade-off between the relative position of the poles and the acoustic volume with respect to zero in the transfer function. The transfer functions for both V1 and V2 (e.g., variable volume 1502) are shown below for the volumetric displacement of the speaker assembly 622.

[0522]

number

[0523]

number

[0524] During the ceremony,

[0525]

number

[0526] As V1 is increased, the gain may decrease, and the speaker may be driven at a higher amplitude to obtain the same sound pressure level. However, increasing V1 may also have the advantage of shifting the complex zeros in the p1 transfer function toward the complex poles. In the limited case where V1→∞, α→1, and there is pole zero cancellation and a flat response. Therefore, increasing V1 reduces both resonance and notch in the p1 transfer function, and ω n One potential advantage is that the p2 pole is moved in that direction, resulting in reduced sensitivity to measurement errors when calculating the p2 / p1 transfer function. Figure 104 is a graph representation of the following equation.

[0527]

number

[0528] Figure 105 is a graph representation of the following equation.

[0529]

number

[0530] Aliasing Higher frequencies can be aliased downwards to the desired frequency, and the aliased frequency can be expressed as follows:

[0531]

number

[0532] In the formula, f s is the sampling frequency, and f n is the frequency of the noise source, n is a positive integer, and f is the aliased frequency of the noise source.

[0533] The demodulation routine may effectively remove noise except for specific frequencies of demodulation. If the sample frequency is dynamically set to a fixed multiple of the demodulation frequency, the frequencies of noise that can be aliased down to the demodulation frequency may be a fixed set of harmonics of its fundamental frequency.

[0534] For example, if the sampling frequency is 8 times the demodulation frequency, the noise frequencies that can be aliased down to that frequency are as follows:

[0535]

number

[0536] During the ceremony,

[0537]

number

[0538] Therefore, for β=16, the following series arises.

[0539]

number

[0540] performance Sensitivity to temperature The sensitivity to temperature can be divided into gain change and noise change. If the temperature deviates by a factor of dT, the resulting gain error can be given by the following equation.

[0541]

number

[0542] Therefore, if the same temperature is used for both sinusoidal sweeps, any error in the temperature measurement can appear as a change in the system's gain.

[0543]

number

[0544] Therefore, for a temperature error of 1°K, the resulting volume error may be 0.3% at 298°K. This error may include both the error of the temperature sensor and the difference between the sensor temperature and the temperature of the air in the volume sensor assembly 148. However, the measurement may be more susceptible to noise in the temperature measurement. Temperature changes during differential sinusoidal sweep can introduce errors that appear more like offsets than gain changes.

[0545]

number

[0546] Therefore, if the measured value fluctuates by 0.1 K during two sinusoidal sweeps, the difference may be 0.012 μL. Thus, it may be more effective to use a consistent temperature estimate for each delivery rather than performing separate temperature measurements for each sinusoidal sweep (as shown in Figure 107).

[0547] The LM73 temperature sensor has a published accuracy of + / -1°C and a resolution of 0.03°C. Furthermore, the LM73 temperature sensor is thought to consistently have an initial transient of approximately 0.3°C, requiring approximately 5 sinusoidal sweeps to become horizontal (as shown in Figure 108).

[0548] Since the above injection pump assemblies (e.g., injection pump assemblies 100, 100', 400, 500) provide discrete delivery of the injectable fluid, the above injection pump assemblies can be modeled entirely in discrete regions (as shown in Figure 109), which can be summarized by the following equation.

[0549]

number

[0550] A discrete-time PI controller can function according to the following equation.

[0551]

number

[0552] The AVS system described above operates by comparing the acoustic responses in fixed volume 1500 and variable volume 1502 with the speaker drive input and extracting the volume of variable volume 1502. Thus, there are microphones (e.g., microphones 626, 630) in contact with each of these separate volumes. In a more holistic manner, the response of variable volume microphone 630 may also be used to detect the presence or absence of the disposable housing assembly 114. Specifically, if the disposable housing assembly 114 is not mounted on the variable volume 1502 (i.e., not positioned in close proximity), the acoustic response to the speaker drive input should be substantially undetectable. However, the response of fixed volume 1500 should still remain relevant to the speaker input. Therefore, microphone data may simply be used to determine whether the disposable housing assembly 114 is mounted by ensuring that both microphones exhibit an acoustic response. If microphone 626 (i.e., the microphone positioned close to the fixed volume 1500) shows an acoustic response, but microphone 630 (i.e., the microphone positioned close to the variable volume 1502) does not show an acoustic response, it can be reasonably concluded that the disposable housing assembly 114 is not installed in the reusable housing assembly 102. Note that a failure of the variable volume microphone 630 may also indicate that the disposable housing assembly 114 is not installed, since a failure of the variable volume microphone 630 may result in mid-range measurements that are almost indistinguishable from the microphone response expected when the disposable housing assembly 114 is not installed.

[0553] The following terms may be used in the discussion below.

[0554] [Table 6]

[0555] As part of the demodulation routine employed in each frequency response calculation, minimum and maximum measurements for 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 microphones 626 and 630 over the entire sinusoidal sweep (as discussed above), as follows:

[0556]

number

[0557]

number

[0558] The difference between these two sums can be simplified as follows:

[0559]

number

[0560] In the formula, δ can be divided by the number of sinusoidal sweeps to obtain the average minimum / maximum difference of the sinusoidal sweeps (which is then compared to a threshold), although the threshold can be multiplied by N equivalently for computational efficiency. Thus, the basic available detection algorithm can be defined as follows:

[0561]

number

[0562] The additional condition that the maximum / minimum difference is greater than a threshold is a check performed to ensure that a faulty speaker is not the cause of the received acoustic response. The algorithm may be iterated over any sinusoidal sweep, and thus, for example, the attachment or detachment of the disposable housing assembly 114 can be detected within at most two consecutive sweeps (i.e., in the worst-case scenario where the disposable housing assembly 114 is removed in the latter half of the ongoing sinusoidal sweep).

[0563] Thresholding for the above algorithm may be based entirely on numerical evidence. For example, an investigation of typical minimum / maximum response differences may show that none of the individual differences are less than 500 ADC counts. Thus, all data investigated while the disposable housing assembly 114 is being attached to and detached from the reusable housing assembly 102 can be assumed to be well below 500 ADC counts, thus showing all minimum / maximum response differences. Therefore, the threshold for δ can be set to T=500.

[0564] Although the volume sensor assembly 148 is described above as being used within an injection pump assembly (e.g., injection pump assembly 100), other configurations are possible and are considered to be within the scope of the disclosure; therefore, this is for illustrative purposes only and is not intended to limit the disclosure. For example, the volume sensor assembly 148 may be used in a process control environment, for example, to control the volume of chemicals mixed together. Alternatively, the volume sensor assembly 148 may be used in a beverage dispensing system, for example, to control the volume of raw materials mixed together.

[0565] Although the volume sensor assembly 148 is described above as utilizing a port (e.g., port assembly 624) as a resonator, other configurations are possible and are considered to be within the scope of this disclosure, and this is for illustrative purposes only. For example, a solid mass (not shown) may be suspended within the port assembly 624 and function as a resonator for the volume sensor assembly 148. Specifically, the mass for the resonator (not shown) may be suspended on a diaphragm (not shown) straddling the port assembly 624. Alternatively, the diaphragm itself (not shown) may serve as 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. Therefore, if the natural frequency of the volume sensor assembly 148 can be measured, the volume of the variable volume 1502 may be calculated.

[0566] The natural frequency of the volume sensor assembly 148 may be measured in a number of different ways. For example, a time-varying force may be applied to a diaphragm (not shown), and the relationship between this force and the motion of the diaphragm (not shown) may be used to estimate the natural frequency of the volume sensor assembly 148. Alternatively, a mass (not shown) may be perturbed and then vibrated. The unforced motion of the mass (not shown) may then be used to calculate the natural frequency of the volume sensor assembly 148.

[0567] The force applied to the resonant mass (not shown) may be achieved in various ways, and embodiments may include, but are not limited to, the following. The speaker assembly 622 may generate time-varying pressure within a fixed volume 1500. The resonant mass (not shown) may be a piezoelectric material that responds to time-varying voltage / current. The resonant mass (not shown) may be an audio coil that responds to time-varying voltage / current. The force applied to the resonant mass may be measured by various methods, and examples of such measurements may include, but are not limited to, the following: • Measure the pressure in a fixed volume. The resonant mass (not shown) may be made of a piezoelectric material. The strain gauge may be connected to a diaphragm (not shown) or other structural member supporting a resonant mass (not shown). Similarly, the displacement of a resonant mass (not shown) may be estimated by measuring the pressure in a variable volume or by measuring it directly in various ways, and embodiments thereof may include, but are not limited to, the following: • Via piezoelectric sensor. • Via a capacity sensor. • Via optical sensors. • Via a Hall effect sensor. • It uses a potentiometer (time-varying impedance) sensor. • Via inductive sensors. • It is transmitted via a linear variable differential transformer (LVDT).

[0568] Furthermore, the resonant block (not shown) may be integrated with either a force-type sensor or a displacement-type sensor (i.e., the resonant block (not shown) may be made from a piezoelectric material).

[0569] The application of force and measurement of displacement may be achieved by a single device. For example, a piezoelectric material may be used as a resonant mass (not shown), and a time-varying voltage / current may be applied to the piezoelectric material to generate a time-varying force. The resulting voltage / current applied to the piezoelectric material may be measured, and the transfer function between the two may be used to estimate the natural frequency of the volume sensor assembly 148.

[0570] As discussed above, the resonant frequency of the volume sensor assembly 148 can be estimated using swept sinusoidal identification. Specifically, the above model fitting may allow the resonant frequency of the port assembly to be extracted from sinusoidal sweep data, which can then be used to determine the delivery volume. The ideal relationship between the resonant frequency and the delivery volume can be expressed as follows:

[0571]

number

[0572] Since the speed of sound will vary with temperature, it may be useful to separate the temperature effect.

[0573]

number

[0574] The volume can then be expressed as a function of the measured resonant frequency and temperature.

[0575]

number

[0576] In the formula, c is the calibration constant.

[0577]

number

[0578] That is the case.

[0579] Next, the injection pump assembly 100 may compare this calculated volume V2 (i.e., representing the actual volume of injectable fluid delivered to the user) with the target volume (i.e., representing the amount of fluid that should have been delivered to the user). For example, suppose the injection pump assembly 100 was delivering a base dose of 0.100 units of injectable fluid to the user every 30 minutes. Furthermore, suppose 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).

[0580] When calculating volume V2, the injection pump assembly 100 may first determine the volume of fluid in the volume sensor chamber 620 prior to the administration of a dose of injectable fluid, and later determine the volume of fluid in the volume sensor chamber 620 after the administration of a dose of injectable fluid. The difference between these two measurements represents V2 (i.e., the actual volume of injectable fluid delivered to the user). Thus, V2 is a differential measurement.

[0581] V2 can be the total void across the diaphragm in the variable volume chamber. Actual fluid delivery to the patient may be the difference in V2 from when the chamber was full until the measuring valve was opened and the chamber was emptied. V2 does not have to be the delivery volume directly. For example, the volume of air may be measured, or a series of differential measurements may be taken. For occlusion, a void measurement may be taken, the chamber may be filled, a complete measurement may be obtained, and then a final measurement may be obtained after the outlet valve is opened. Thus, the difference between the first and second measurements may be the amount delivered, and the difference between the second and third measurements may be the amount delivered to the patient.

[0582] Therefore, the electrical control assembly 110 may determine that the delivered injectable fluid is 0.005 units less than the required amount. 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 may be dispensed. Alternatively, the electrical control assembly 110 may provide an appropriate signal to the mechanical control assembly 104 so that the additional dose may be dispensed along with the next dose. Thus, during the 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 target and the delivered amount.

[0583] See also Figure 110, which illustrates one specific implementation of a control system for controlling the amount of injectable fluid currently being injected, based at least partially on the amount of injectable fluid previously administered. Specifically, continuing the above embodiment, for illustrative purposes, suppose that the electrical control assembly 110 requests the delivery of a 0.100 unit dose of injectable fluid to the user. Thus, the electrical control assembly 110 may provide the volume controller 1602 with a target differential volume signal 1600 (identifying a partial base dose of 0.010 units of injectable fluid per cycle of the shape memory actuator 112). Thus, in this particular embodiment, the shape memory actuator 112 may need to be circulated 10 times to achieve the desired base dose of 0.100 units of injectable fluid (i.e., 10 cycles × 0.010 units / cycle = 0.100 units). Subsequently, the volume controller 1602 may provide an "on-time" signal 1606 to the SMA (i.e., shape memory actuator) controller 1608. Additionally, the battery voltage signal 1610 is also provided to the SMA controller 1608.

[0584] 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. Therefore, if the voltage level of the battery 606 is reduced, the amount of joules applied to the shape memory actuator 112 may also be reduced over a 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. Therefore, by monitoring the voltage level of the battery 606 (via the battery voltage signal 1610), the type of signal applied to the shape memory actuator 112 may be varied to ensure that an appropriate amount of thermal energy is applied to the shape memory actuator 112 regardless of the battery voltage level.

[0585] The SMA controller 1608 may process the "on-time" signal 1606 and the battery voltage signal 1610 to determine the appropriate SMA drive signal 1612 to apply to the shape memory actuator 112. One embodiment of the SMA drive signal 1612 may be a series of binary pulses in which the amplitude of the SMA drive signal 1612 essentially controls the stroke length of the shape memory actuator 112 (and thus the pump assembly 106), and the 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). Furthermore, since the SMA drive signal 1612 represents 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 a discrete-time integrator 1614 to produce a volume signal 1616 that can indicate the total amount of injectable fluid injected during multiple cycles of the shape memory actuator 112. For example, since injecting 0.100 units of injectable fluid (as discussed above) may require 10 cycles of the shape memory actuator 112 (0.010 units per cycle), 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).

[0586] The SMA drive signal 1612 may, for example, activate the pump assembly 106 over one cycle, resulting in the filling of the volume sensor chamber 620 contained within the volume sensor assembly 148. The injection pump assembly 100 may then perform a first measurement of the volume of fluid contained within the volume sensor chamber 620 (as discussed above). Furthermore, as discussed above, the measuring valve assembly 610 may be subsequently energized to deliver all or part of the fluid in the volume sensor chamber 620 to the user. The injection pump assembly 100 may then perform a measurement of the volume of fluid contained within the volume sensor chamber 620 (as described above) and use these two measurements to determine V2 (i.e., the actual volume of injectable fluid delivered to the user during the current cycle of the shape memory actuator 112). Once determined, V2 (i.e., as represented by signal 1618) may be provided (i.e., feedback) to the volume controller 1602 for comparison with a previously received target differential volume.

[0587] Continuing the above embodiment, where the differential target volume was 0.010 units of injectable fluid, we assume that V2 (i.e., as represented by signal 1618) identifies 0.009 units of injectable fluid as delivered to the user. Thus, the injection pump assembly 100 may increase the next differential target volume to 0.011 units to compensate for the previous 0.001 unit deficit. Thus, as discussed above, the amplitude and / or duty cycle of the SMA drive signal 1612 may be increased when delivering the next basic dose of injectable fluid to the user. This process may be repeated over the remaining 9 cycles of the shape memory actuator 112 (as discussed above), and the discrete-time integrator 1614 may continue to integrate the SMA drive signal 1612 (to generate the volume signal 1616), which can define the total amount of injectable fluid delivered to the user.

[0588] See also Figure 111, which shows one possible embodiment of the volume controller 1602. In this particular implementation, the volume controller 1602 may include a PI (proportional-integral) 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, in the situation described above, where the target differential volume signal 1600 identifies a partial base dose of 0.010 units of fluid that can be injected per cycle of the shape memory actuator 112, the feedforward controller 1652 may define an initial "on-time" of, for example, 1 millisecond. The feedforward controller 1652 may include a reference table that defines the initial "on-time" based, for example, 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).

[0589] See also Figure 112, which shows one possible embodiment of the feedforward controller 1652. In this particular implementation, the feedforward controller 1652 may define a constant signal 1658 and may include an amplifier 1660 (e.g., a unified gain amplifier) ​​whose output may be summed with the constant signal 1658 at the summing node 1662. The resulting sum signal (i.e., signal 1664) may be provided as an input signal to, for example, a reference table 1666, which may be processed to generate the output signal of the feedforward controller 1652.

[0590] As discussed above, the pump assembly 106 may be controlled by the shape memory actuator 112. Furthermore, as discussed above, the SMA controller 1608 may process the "on-time" signal 1606 and the battery voltage signal 1610 to determine the appropriate SMA drive signal 1612 to apply to the shape memory actuator 112.

[0591] See also Figures 113-114, which show one specific implementation of the SMA controller 1608. As discussed above, the SMA controller 1608 may respond to an "on-time" signal 1606 and a battery voltage signal 1610, and may provide an SMA drive signal 1612 to the shape memory actuator 112. The SMA controller 1608 may include a feedback loop (including a unit delay 1700), the output of which may be multiplied by the battery voltage signal 1610 in a multiplier 1702. The output of the multiplier 1702 may be amplified, for example, by a unified 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 the unified gain amplifier 1708. The SMA controller may also include a feedforward controller 1710 to provide an initial value for the SMA drive signal 1612 (similar to the feedforward controller 1652 of the volume controller 1602, see Figure 112). The output of the feedforward controller 1710 may be summed with the output of amplifier 1708 and the integral representation of the output of amplifier 1708 (i.e., signal 1714) at the summing node 1712 to form the SMA drive signal 1612.

[0592] The SMA drive signal 1612 may be provided to a control circuit that achieves the application of 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) via the switching assembly 1716 in a manner that achieves a 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 so as to form a battery voltage signal 1610 (which may be applied to the SMA controller 1608).

[0593] When power is applied to the shape memory actuator 112, the voltage may be applied over a fixed time period in the following ways: a) a fixed duty cycle with an unadjusted voltage, b) a fixed duty cycle with an adjusted voltage, c) a variable duty cycle based on a measured current value, d) a variable duty cycle based on a measured voltage value, and e) a variable duty cycle based on the square of a measured voltage value. Alternatively, the voltage may be applied to the shape memory actuator 112 over a variable time period based on a measured impedance.

[0594] When an unadjusted voltage is applied over a fixed time period in a fixed duty cycle, inner loop feedback may not be used, and the shape memory actuator may be driven in a fixed duty cycle and at an on-time determined by the outer volume loop.

[0595] When a voltage adjusted over a fixed time period is applied in a fixed duty cycle, inner loop feedback may not be used, and the shape memory actuator 112 may be driven in a fixed duty cycle and at an on-time determined by the outer volume loop.

[0596] In a variable duty cycle based on a measured current value, when an unadjusted voltage is applied, the actual current applied to the shape memory actuator 112 may be measured, and the duty cycle may be adjusted during the operation of the shape memory actuator 112 to maintain the correct average current.

[0597] In a variable duty cycle based on a measured voltage value, when an unadjusted voltage is applied, the actual voltage applied to the shape memory actuator 112 may be measured, and the duty cycle may be adjusted during the operation of the shape memory actuator 112 to maintain the correct average voltage.

[0598] In a variable duty cycle based on the square of the measured voltage value, when an unadjusted voltage is applied, the actual voltage applied to the shape memory actuator 112 may be measured, and the duty cycle may be adjusted during the operation of the shape memory actuator 112 to maintain the square of the voltage at a level necessary to provide the shape memory actuator 112 with a desired level of power (based on the impedance of the shape memory actuator 112).

[0599] See also Figures 114A-114B, which show other implementations of the SMA controller 1608. Specifically, Figure 114A is an electrical circuit diagram including a microprocessor and various control loops, which may be configured to provide a PWM signal that can open and close a switch assembly. The switch assembly may control the current that flows through the shape memory actuator. A battery may supply current to the shape memory actuator. Furthermore, 114B discloses a volume controller and an internal shape memory actuator controller. The shape memory actuator controller may provide a PWM signal to the pump, which may be modified based on the battery voltage. This may 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.

[0600] In our preferred embodiment, the duty cycle is varied based on the measured battery voltage to provide nearly consistent power. The duty cycle is adjusted to compensate for lower battery voltages. Battery voltage can vary for two reasons: 1) as the battery discharges, the voltage slowly decreases, and 2) when a load is applied to the battery, its voltage gradually decreases due to its internal impedance. This occurs in any kind of system, and this is compensated for by adjusting the duty cycle and thus mitigating lower or fluctuating battery voltages. The battery voltage may be measured by a microprocessor. In other systems, 1) the voltage may be regulated (a regulator is put in to maintain the voltage at a stable voltage), and 2) the feedback may be based on something else (i.e., motor speed or position, not necessarily measuring the battery voltage).

[0601] Other configurations may be used to control the shape memory actuator. For example, A) the shape memory actuator may be controlled in a fixed duty cycle with an unregulated voltage. As the voltage fluctuates, the reproducibility of heating the shape memory actuator is reduced. B) A fixed duty cycle with a regulated voltage may be used to compensate for changes in battery voltage. However, regulating the voltage downward is not very efficient in terms of energy. C) The duty cycle may be varied based on changes in current (this may require a more complex measurement circuit). 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 over a variable time amount based on a measured impedance (e.g., the impedance may be measured using a Wheatstone gauge (not shown)). The impedance of the shape memory actuator may correlate with the strain (i.e., how much the SMA moves may be correlated based on its impedance).

[0602] Referring to Figure 115, as discussed above, to improve the safety of the injection pump assembly 100, the electrical control assembly 110 may include two separate and individual 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 relay / switch assemblies 1804, 1806 that control the functionality of the shape memory actuators 112, 632 (each, respectively) (in this embodiment). The command processor 1802 may receive feedback from the signal regulator 1808 regarding the state (e.g., voltage level) of the voltage signal applied to the shape memory actuators 112, 632. The command processor 1800 may control the relay / switch assembly 1810 independently of the relay / switch assemblies 1804, 1806. Therefore, when an injection event is desired, both the supervisor processor 1800 and the command processor 1802 must agree that the injection event is appropriate, and both must activate their respective relays / switches. If either the supervisor processor 1800 or the command processor 1802 fails to activate its respective relay / switch, the injection event will not occur. Thus, the safety of the injection pump assembly 100 is improved through the use of the supervisor processor 1800 and the command processor 1802, and through their cooperation and simultaneous occurrence, which must occur.

[0603] The supervisor processor may prevent the command processor from delivering a command when it should not, and may alert if the command processor fails to deliver a command when it should. The supervisor processor may deactivate a relay / switch assembly if the command processor activates the wrong switch or attempts to apply power for an excessively long time.

[0604] The supervisor processor may perform redundant calculations regarding how much insulin should be delivered (i.e., double-check the command processor's calculations). The command processor may determine the delivery schedule, and the supervisor processor may redundantly check these calculations.

[0605] The supervisor also maintains redundant profiles (delivery profiles) in RAM so that the command processor can perform calculations correctly, but if there is faulty RAM, it will cause the command to produce incorrect results. The supervisor uses, for example, a local copy of the base profile for double-checking.

[0606] The supervisor can double-check the AVS measurement, review the AVS calculation, and apply safety checks. A double-check is performed each time an AVS measurement is taken.

[0607] See also Figure 116, one or more of the supervisor processor 1800 and the command processor 1802 may diagnose various parts of the injection pump assembly 100. For example, the voltage dividers 1812 and 1814 may be configured to monitor voltages (V1 and V2, respectively) sensed, for example, at the distal end of the shape memory actuator 112. With the signals applied to the relay / switch assemblies 1804 and 1810 in mind, the values ​​of voltages V1 and V2 may allow for diagnosis of various components of the circuit shown in Figure 116 (as shown in illustrative diagnostic table 1816).

[0608] As discussed above, as illustrated in Figures 115-116, to improve the safety of the injection pump assembly 100, the electrical control assembly 110 may include multiple microprocessors (e.g., supervisor processor 1800 and command processor 1802), each of which may be required to interact and operate simultaneously to achieve the delivery of a certain amount of injectable fluid. If the microprocessors fail to interact / operate simultaneously, the delivery of the injectable fluid may fail, triggering one or more alarms, thus improving the safety and reliability of the injection pump assembly 100.

[0609] A master alarm may be used to track volume errors over time. Therefore, if the sum of errors b...

Claims

[Claim 1] An article having clarity, novelty, and inventive step.

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