Occlusion sensing for an infusion pump

• US 9,480,793 B2
• Filed: 08/20/2015
• Issued: 11/01/2016
• Est. Priority Date: 05/21/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Mhatre, Amit, Wu, Jian Yao, Wenger, Mitchell, Friedman, Steven M.
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US14/830,841
• Publication Number:
  US 20150352279A1
• Time in Patent Office: 439 Days
• Field of Search: 604 65- 67, 604/131, 604/151, 128/DIG.12, 128/DIG.13
• US Class Current: 1/1
• 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 removably attachable to a disposable pump device, the occlusion sensor system comprising:

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

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

wherein the light sensor receives light from the light emitter that undergoes total internal reflection within the light transmissive member; and

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

2. 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.

3. The occlusion sensor system of claim 2, 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.

4. The occlusion sensor system of claim 3, 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.

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

activating a light emitter to direct light into a light transmissive member;

receiving signals from a light sensor by control circuitry arranged in a controller device housing, the signals from the light sensor being generated in response to the light sensor receiving light from the light emitter that undergoes total internal reflection within the light transmissive member in a region proximate to a flexible membrane, the light transmissive member aligned with the light emitter and a light sensor when the controller device housing is removably attached to a disposable single-use pump device; and

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

6. The method of claim 5, wherein the determining step comprises inputting data from the light sensor and executing a comparative process to determine if the occlusion exists.

7. The method of claim 5, 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.

8. The method of claim 7, wherein the light emitter is activated one or more times shortly before the drive system is activated.

9. An occlusion sensor system for an infusion pump system, the occlusion sensor system comprising:

a light emitter and a light sensor in electrical communication with control circuitry of the infusion pump system;

a light transmissive member aligned with the light emitter and the light sensor; and

a flexible membrane spaced apart from the light transmissive member by a cavity,

wherein the light sensor receives light from the light emitter that undergoes total internal reflection within the light transmissive member.

10. The occlusion sensor system of claim 9, wherein the light emitter and the light sensor are arranged in a reusable controller device.

11. The occlusion sensor system of claim 10, wherein the light transmissive member is arranged in a disposable single-use pump device removably attached to the reusable controller device.

12. The occlusion sensor system of claim 11, wherein the light transmissive member is arranged in a cap device of the disposable single-use pump device.

13. The occlusion sensor system of claim 12, wherein the light emitter is configured to direct light towards a fluid channel in the cap device of the disposable single-use pump device and the light sensor is configured to receive light reflected from the cap device.

14. The occlusion sensor system of claim 9, wherein the light from the light emitter undergoes total internal reflection within the light transmissive member at an interface with an air cavity adjacent to the light transmissive member.

15. The occlusion sensor system of claim 9, wherein the light emitter is an infrared light emitter.

16. The occlusion sensor system of claim 9, wherein the light emitter and the light sensor are reusable with a series of disposable single-use pump devices.

17. The occlusion sensor system of claim 9, wherein the flexible membrane is arranged in a disposable single-use pump device.

18. The occlusion sensor system of claim 17, wherein the flexible membrane comprises a material having a refractive index that is substantially similar to the light transmissive member.

19. The occlusion sensor system of claim 17, wherein the flexible membrane is separated from a medicine flow path by an air pocket in a capillary tube.

20. The occlusion sensor system of claim 9, wherein the light from the light emitter undergoes total internal reflection within the light transmissive member at an interface with the cavity when the flexible membrane is spaced apart from the light transmissive member by the cavity.

21. The occlusion sensor system of claim 20, wherein in response to a flow condition in a flow path, the flexible membrane is adjustable to at least partially abut the light transmissive member.

22. The occlusion sensor system of claim 21, wherein when the flexible membrane at least partially 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 to reduce an amount of light internally reflected by the light transmissive member and received by the light sensor.

23. The occlusion sensor system of claim 9, wherein the control circuitry receives signals from the light sensor to determine a fluid pressure condition in a flow path extending from the disposable single-use pump device.

24. The occlusion sensor system of claim 23, 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.