Occlusion sensing for an infusion pump

• US 7,892,199 B2
• Filed: 05/21/2007
• Issued: 02/22/2011
• Est. Priority Date: 05/21/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc (Abbott Laboratories)
• Inventors: Mhatre, Amit, Friedman, Steven, Wu, Jian Yao, Wenger, Mitchell
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US11/751,383
• Publication Number:
  US 20080294094A1
• Time in Patent Office: 1,373 Days
• Field of Search: 604 65- 67, 604/131, 128/DIG.12, 128/DIG.13, 128/DIG.1
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G01L 9/0077 for measuring reflected light

Abstract

Some embodiments of an infusion pump system may include an occlusion sensor that can be used to detect when an occlusion exists in the fluid path between the medicine reservoir and the infusion site on the user'"'"'s skin. Such an occlusion may occur, for example, when the fluid flow line (e.g., a cannula, infusion set tubing, or the like) is kinked. If the medicine dispensation path to the user is occluded, the user may receive no dosage or a lower dosage of the medicine. As such, the occlusion sensor can be used to indicate when the fluid is flowing or not flowing, thereby permitting the infusion pump system to communicate an alarm to the user if an occlusion exists.

Claims

1. An occlusion sensor system for an infusion pump system including a reusable controller device that is removably attachable to a disposable single-use pump device housing a medicine reservoir therein, the occlusion sensor system comprising:

a light emitter and a light sensor arranged in the reusable controller device, the light emitter and the light sensor being in electrical communication with control circuitry of the reusable controller device;

a light transmissive member arranged in the disposable single-use pump device, the light transmissive member being aligned with the light emitter and the light sensor when the reusable controller device is removably attached to a disposable single-use pump device; and

a flexible membrane arranged in the disposable single-use pump device, the flexible membrane being spaced apart from the light transmissive member by a cavity when in a first operative position,

wherein the light sensor receives light from the light emitter that is internally reflected by the light transmissive member.

2. The occlusion sensor system of claim 1, wherein the light emitter and the light sensor are reusable with a series of disposable single-use pump devices.

3. The occlusion sensor system of claim 1, wherein when the flexible membrane is in the first operative position, the light from the light emitter undergoes total internal reflection within the light transmissive member at an interface with the cavity.

4. The occlusion sensor system of claim 3, wherein in response to a flow condition in a flow path extending from the disposable single-use pump device, the flexible membrane is adjustable to a second operative position in which the flexible membrane abuts the light transmissive member.

5. The occlusion sensor system of claim 4, wherein when the flexible membrane is in the second operative position, at least a portion the light from the light emitter passes from the light transmissive member and into the flexible membrane at an interface between the light transmissive member and the flexible membrane.

6. The occlusion sensor system of claim 1, wherein the flexible membrane comprises a material having a refractive index that is substantially similar to the light transmissive member.

7. The occlusion sensor system of claim 1, wherein the flexible membrane is separated from a medicine flow path by an air pocket in a capillary tube.

8. The occlusion sensor system of claim 1, wherein the light transmissive member is arranged in a cap component of the disposable single-use pump device.

9. The occlusion sensor system of claim 1, wherein the light emitter and light sensor are positioned adjacent to the cap component when the reusable controller device is removably attached to the disposable single-use pump device.

10. The occlusion sensor system of claim 9, wherein the control circuitry includes a detection module stored in one or more memory devices, the detection module including instructions that, when executed, performs a comparative process to determine if an occlusion exists.

11. The occlusion sensor system of claim 10, wherein the alarm trigger module activates a set of escalating alarms.

12. The occlusion sensor system of claim 9, wherein the control circuitry includes an alarm trigger module that activates a user interface of the reusable controller device to communicate one or more alarms.

13. The occlusion sensor system of claim 1, wherein the control circuitry receives signals from light sensor to determine if an occlusion is present in a flow path extending from the disposable single-use pump device.

14. A method for detecting an occlusion in a flow path from an infusion pump system, comprising:

activating a light emitter arranged in a controller device housing to direct light outside of the controller device housing and into a light transmissive member arranged in a pump device that is removably attached to the controller device housing to provide an electrical connection between the pump device and the controller device;

receiving signals from a light sensor arranged in the controller device housing, the signals from the light sensor being generated in response to the light sensor receiving light from the light emitter that is internally reflected by the light transmissive member in a region proximate to a flexible membrane arranged in the pump device, the flexible membrane being spaced apart from the light transmissive member by a cavity when in a first operative position; and

determining if an occlusion exists in a flow path based at least in part on the signals received from the light sensor.

15. The method of claim 14, further comprising, in response to a determination that an occlusion exists in the flow path, activating an alarm to a user indicating that an occlusion exists.

16. The method of claim 15, further comprising activating a set of escalating alarms in response to the determination that the occlusion exists in the flow path.

17. The method of claim 14, wherein the determining step comprises inputting data from the light sensor and executing comparative process to determine if the occlusion exists.

18. The method of claim 14, further comprising activating a drive system at least partially housed in the pump device so as to force medicine from the pump device and into the flow path.

19. The method of claim 18, wherein the light emitter is activated one or more times shortly before the drive system is activated.

20. An occlusion sensor system for detecting an occlusion in a flow path from an insulin infusion pump system, the occlusion sensor system comprising:

a fluid channel defined in a cap of a pump device, the fluid channel being at least a portion of an insulin flow path;

a flexible membrane in the cap adjacent to the fluid channel so as to define at least a portion of a wall of the fluid channel;

an air cavity in the cap adjacent to the flexible membrane and opposite the fluid channel;

a light transmissive member in the cap adjacent to the air cavity, the light transmissive member being arranged opposite the flexible membrane such that fluid pressure in the fluid channel above a threshold value causes the flexible membrane to deform into the air cavity and toward the light transmissive member.

a light emitter and a light sensor arranged in a controller device and outside of the pump device, the light emitter and the light sensor being aligned with the cap of the pump device when the controller device is removably attached to the pump device.

21. The occlusion sensor system of claim 20, wherein the light sensor receives light from the light emitter that is internally reflected by the light transmissive member.

22. The occlusion sensor system of claim 20, wherein when the flexible membrane is in a non-abutting position with the light transmissive member, the light from the light emitter undergoes total internal reflection within the light transmissive member at an interface with the air cavity.

23. The occlusion sensor system of claim 22, wherein in response to an occlusion in a flow path extending from the fluid channel, the flexible membrane is adjustable to abut the light transmissive member.

24. The occlusion sensor system of claim 23, wherein when the flexible membrane abuts the light transmissive member, at least a portion the light from the light emitter passes from the light transmissive member and into the flexible membrane at an interface between the light transmissive member and the flexible membrane.

25. The occlusion sensor system of claim 24, wherein the flexible membrane comprises a material having a refractive index that is substantially similar to the light transmissive member.