Method for occlusion detection for an infusion pump system

• US 9,610,404 B2
• Filed: 08/18/2014
• Issued: 04/04/2017
• Est. Priority Date: 09/07/2011
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc. (Abbott Laboratories)
• Inventors: Rotstein, Yaron
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US14/461,678
• Publication Number:
  US 20150005736A1
• Time in Patent Office: 960 Days
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 39/284 Lever clamps
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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

Abstract

Some embodiments of an infusion pump system include an occlusion detection system to detect when an occlusion exists in the fluid path between the medicine reservoir and the infusion site located, for example, on the user'"'"'s skin. The occlusion detection system can be configured to self-calibrate in a manner that accounts for changes in environmental conditions, such as ambient temperature, pressure, or the like, so that the occlusion detection system provides reliable feedback to a user as to the occluded or non-occluded state of the medicine flow path.

Claims

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

activating a reference light emitter to direct light toward a light sensor housed in an infusion pump system, wherein the light sensor generates an electrical signal in response to receiving light from the reference light emitter;

determining a first value indicative of light detected at the light sensor from the reference light emitter;

activating a primary light emitter to direct light toward a medicine flow path for the infusion pump system, the medicine flow path comprising a flexible membrane in fluid communication with a fluid channel that at least partially defines an insulin flow path between an insulin reservoir and an output port, wherein a fluid pressure in the fluid channel acts upon the flexible membrane, wherein the light sensor receives a least a portion of the light emitted from the primary light emitter, wherein the light sensor receives light from the primary light emitter that is internally reflected by a light transmissive member, the light transmissive member having two generally flat surfaces through which the light from the primary light emitter enters and exits the light transmissive member, the medicine flow path further comprising an air cavity positioned adjacent to the flexible membrane and generally opposite the fluid channel, wherein the light transmissive member is adjacent to the air cavity, wherein the reference light emitter is spaced apart from the primary light emitter such that the light emitted from the reference light emitter is received by the light sensor without being directed towards the flexible membrane or passing through the light transmissive member;

determining a second value indicative of light detected at the light sensor from the primary light emitter; and

determining if a fluid pressure in the fluid channel exceeds a threshold value based at least in part on a comparison of the second value to the first value; and

providing feedback regarding the occluded or non-occluded state of the medicine flow path.

2. The method of claim 1, wherein a control circuitry activates the primary light emitter in isolation from activation of the reference light emitter.

3. The method of claim 2, wherein the control circuitry electrically is connected to the primary light emitter, the reference light emitter, and the light sensor.

4. The method of claim 2, wherein the control circuitry determines the fluid pressure.

5. The method of claim 1, wherein the feedback comprises an occlusion alarm.

6. The method of claim 5, wherein the occlusion alarm is generated by the infusion pump system.

7. The method of claim 1, wherein the light transmissive member is 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.

8. The method of claim 7, wherein the primary light emitter is configured to align with the light transmissive member and emit light into the light transmissive member;

wherein the light sensor is configured to align with the light transmissive member and receive light from the primary light emitter that passes through the light transmissive member; and

wherein the reference light emitter configured to emit light that is received by the light sensor, wherein the reference light emitter is spaced apart from the primary light emitter.

9. The method of claim 8, 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.

10. The method of claim 9, wherein in response to a pressure in a flow path extending from the fluid channel exceeding a threshold, the flexible membrane expands to abut the light transmissive member.

11. The method of claim 10, wherein when the flexible membrane abuts the light transmissive member, at least a portion the light from the primary 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.

12. The method of claim 8, wherein the light sensor, the primary light emitter, and the reference light emitter are housed in a reusable controller device while the flexible membrane, the air cavity, and the light transmissive member are components of a cap device that attaches to a disposable pump device configured to removably attach to the reusable controller device.