Occlusion detection for an infusion pump system

• US 8,808,230 B2
• Filed: 09/07/2011
• Issued: 08/19/2014
• Est. Priority Date: 09/07/2011
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Asante Solutions, Inc
• Inventors: Rotstein, Yaron
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): MATNEY, BROOKE MARIE
• Application Number:
  US13/226,689
• Publication Number:
  US 20130060194A1
• Time in Patent Office: 1,077 Days
• Field of Search: 604/67, 604/151, 604/253, 604/93.01, 604/65, 604/500, 604/131, 604/181, 604/189, 604/110, 737/15
• US Class Current: 604/67
• 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. 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 that at least partially defines an insulin flow path between an insulin reservoir and an output port;

a flexible membrane in fluid communication with the fluid channel so that fluid pressure in the fluid channel acts upon the flexible membrane;

an air cavity positioned adjacent to the flexible membrane and generally opposite the fluid channel;

a light transmissive member 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 primary light emitter configured to align with the light transmissive member and emit light into the light transmissive member;

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

a 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.

2. The occlusion sensor system of claim 1, 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 passing through the light transmissive member.

3. The occlusion sensor system of claim 1, further comprising control circuitry electrically connected to the primary light emitter, the reference light emitter, and the light sensor, wherein the control circuitry activates the primary light emitter in isolation from activation of the reference light emitter.

4. The occlusion sensor system of claim 3, wherein the control circuitry compares a first value indicative of light detected at the light sensor from the primary light emitter to a second value indicative of light detected at the light sensor from the reference light emitter.

5. The occlusion sensor system of claim 4, wherein in response to the comparison of the first value to the second value being outside of a threshold range, the control circuitry generates an occlusion alarm output from the infusion pump system.

6. The occlusion sensor system of claim 1, wherein the light sensor receives light from the primary light emitter that is internally reflected by the 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.

7. The occlusion sensor system of claim 1, 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.

8. The occlusion sensor system of claim 7, 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.

9. The occlusion sensor system of claim 8, 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.

10. The occlusion sensor system of claim 1, 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.

11. 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 that defines a space to receive medicine therein, the occlusion sensor system comprising:

a primary light emitter, a reference light emitter, and a light sensor arranged in the reusable controller device, wherein the primary light emitter, the reference light emitter, and the light sensor are in electrical communication with control circuitry housed inside the reusable controller device; and

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

wherein in response to activation of the primary light emitter, the light sensor receives at least a portion of the light from the primary light emitter that passes through the light transmissive member, and

wherein in response to activation of the reference light emitter, the light sensor receives a least a portion of the light that is emitted from the reference light emitter without passing through the light transmissive member.

12. The occlusion sensor system of claim 11, further comprising:

a cavity positioned adjacent to the light transmissive member, a flexible membrane that defines at least one wall of the air cavity and that is arranged in the disposable single-use pump device, and a fluid channel that at least partially defines a medicine flow path between the medicine reservoir reservoir and an output port, the fluid channel being in fluid communication with the flexible membrane so that fluid pressure in the fluid channel acts upon the flexible membrane.

13. The occlusion sensor system of claim 12, wherein when the flexible membrane is in a first operative position, the light from the primary light emitter undergoes total internal reflection within the light transmissive member at an interface with the cavity.

14. The occlusion sensor system of claim 13, 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.

15. The occlusion sensor system of claim 11, further comprising control circuitry housed in the reusable controller device and electrically connected to the primary light emitter, the reference light emitter, and the light sensor, wherein the control circuitry activates the primary light emitter at a time different from activation of the reference light emitter.

16. The occlusion sensor system of claim 15, wherein the control circuitry compares a first value indicative of light detected at the light sensor from the primary light emitter to a second value indicative of light detected at the light sensor from the reference light emitter.

17. The occlusion sensor system of claim 16, wherein in response to the comparison of the first value to the second value being outside of a threshold range, the control circuitry generates an occlusion alarm output from the infusion pump system.

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

a primary light emitter configured to emit light toward an insulin flow path;

a light sensor configured to receive at least a portion of the light from the primary light emitter after the light is emitted toward the insulin flow path, wherein the light sensor outputs an electrical signal in response to receiving light;

a reference light emitter configured to emit light that is received by the light sensor, wherein the reference light emitter is separate from the primary light emitter; and

control circuitry electrically connected to the primary light emitter, the reference light emitter, and the light sensor, wherein the control circuitry compares a first value indicative of light detected at the light sensor from the primary light emitter to a second value indicative of light detected at the light sensor from the reference light emitter, and in response to the comparison of the first value to the second value being outside of a threshold range, the control circuitry generates an occlusion alarm for output via a user interface.

19. The occlusion sensor system of claim 18, further comprising:

a flexible membrane in fluid communication with the insulin flow path so that fluid pressure from the insulin flow path acts upon the flexible membrane;

a cavity positioned adjacent to the flexible membrane and generally opposite the insulin flow path; and

a light transmissive member adjacent to the cavity, the light transmissive member being arranged opposite the flexible membrane such that fluid pressure in the insulin flow path above a threshold value causes the flexible membrane to deform into the cavity and toward the light transmissive member, wherein the primary light emitter is configured to align with the light transmissive member and emit light into the light transmissive member.

20. The occlusion sensor system of claim 19, 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 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.