Occlusion sensing for an infusion pump

• US 9,717,849 B2
• Filed: 10/20/2016
• Issued: 08/01/2017
• Est. Priority Date: 05/21/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc. (Abbott Laboratories)
• Inventors: Wu, Jian Yao, Friedman, Steven A., Mhatre, Amit, Wenger, Mitchell
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US15/298,676
• Publication Number:
  US 20170100538A1
• Time in Patent Office: 285 Days
• Field of Search: 605 65- 67, 605131, 605151, 128DIG 12, 128 13
• 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. A method for detecting an occlusion in an infusion pump system, the method comprising:

delivering fluid through a flow path, the flow path being in fluid communication with a flexible membrane such that pressure within the flow path above a threshold pressure causes the flexible membrane to expand, wherein the flexible membrane is positioned adjacent a light transmissive member such that the expansion of the flexible membrane results in the pressing of the flexible membrane against at least a portion of a surface of the light transmissive member;

directing light through said light transmissive member towards said surface;

detecting light reflected by said surface, wherein a reduction in light reflected by said surface indicates the possible occurrence of an occlusion.

2. The method of claim 1, wherein directing light through said light transmissive member towards said surface comprises directing light towards said surface at a non-orthogonal angle.

3. The method of claim 1, wherein directing light through said light transmissive member towards said surface comprises directing light towards said surface at a 45-degree angle.

4. The method of claim 1, wherein the delivered fluid is insulin.

5. The method of claim 1, wherein light is detected using a light sensor, the method further comprising 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, wherein the light is directed towards said surface by a light emitter.

8. The method of claim 7, wherein delivering fluid through a flow path comprises activating a drive system at least partially housed in a pump device so as to force fluid from the pump device and into the flow path, wherein the light emitter is activated one or more times shortly before the drive system is activate.

9. An infusion pump system adapted to detect an occlusion comprising:

a drive system adapted to force fluid from a reservoir into a flow path;

a flexible membrane in fluid communication with the flow path such that pressure within the flow path above a threshold pressure causes the flexible membrane to expand;

a light transmissive member having at least a portion of a surface arranged adjacent to the flexible membrane such that the expansion of the flexible membrane results in the pressing of the flexible membrane against at least a portion of said surface;

a light emitter arranged to direct light through the light transmissive member towards said surface;

a light sensor arranged to detect light reflected by said surface; and

control circuitry adapted to detect a possible occurrence of an occlusion based on a reduction of an amount of light detected by the light sensor.

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 and flexible membrane are 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 and flexible membrane are arranged in a cap device of the disposable single-use pump device.

13. 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.

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

15. 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.

16. The occlusion sensor system of claim 9 wherein the flexible membrane comprises a material having a refractive index that is substantially similar to the light transmissive member.

17. The occlusion sensor system of claim 9 wherein the flexible membrane is separated from the flow path by an air pocket in a capillary tube.

18. 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.

19. The occlusion sensor system of claim 18, wherein when the flexible membrane at least partially abuts the light transmissive member, at least a portion of 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.

20. 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, 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.