Occlusion Sensing for an Infusion Pump

• US 20110118662A1
• Filed: 01/18/2011
• Published: 05/19/2011
• Est. Priority Date: 05/21/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Asante Solutions, Inc
• Inventors: Wenger, Mitchell, Mhatre, Amit, Friedman, Steven, Wu, Jian Yao
• Granted Patent: US 8,852,141 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• 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 infusion pump system for dispensing medicine, comprising:

a pump device including a drive system to dispense a medicine from the pump device and a cap having a fluid channel through which the medicine is dispensed, the cap having a light transmissive member arranged proximate to the fluid channel; and

a removable controller device including control circuitry to communicate with the drive system of the pump device when the pump device is removably attached to the controller device, the removable controller device including a light emitter and a light sensor that are in electrical communication with control circuitry, wherein the light sensor receives light from the light emitter that is internally reflected by the light transmissive member in the cap.

2. The infusion pump system of claim 1, 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.

3. The infusion pump system of claim 1, wherein the control circuitry receives signals from light sensor to determine if an occlusion is present downstream from the fluid channel.

4. The infusion pump system of claim 3, 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.

5. The infusion pump system of claim 3, 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.

6. The infusion pump system of claim 5, wherein the alarm trigger module activates a set of escalating alarms.

7. The infusion pump system of claim 1, wherein the light transmissive member is included in the cap of the pump device so that the light transmissive member aligns with the light emitter and the light sensor of the controller device when the pump device is removably attached to the controller device.

8. The infusion pump system of claim 7, wherein the removable controller device is a reusable controller and the pump device is a disposable single-use pump device, wherein the light emitter and the light sensor of the controller device are reusable with a series of disposable single-use pump devices.

9. The infusion pump system of claim 1, wherein the cap of the pump device further comprises a flexible membrane that is spaced apart from the light transmissive member by a cavity when in a first operative position.

10. The infusion pump system of claim 9, 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.

11. The infusion pump system of claim 10, wherein in response to a flow condition in a flow path extending from the pump device, the flexible membrane is adjustable to a second operative position in which the flexible membrane abuts the light transmissive member.

12. The infusion pump system of claim 11, 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.

13. The infusion pump system of claim 9, wherein the flexible membrane comprises a material having a refractive index that is substantially similar to the light transmissive member.

14. The infusion pump system of claim 9, wherein the flexible membrane is separated from said fluid channel of the cap by an air pocket in a capillary tube.

15. The infusion pump system of claim 9, wherein the pump device removably attaches to the controller device so as to provide an electrical connection between the pump device and the controller device.

18. The method of claim 15, wherein the signals from the light sensor are 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 cap component of the pump device, the flexible membrane being spaced apart from the light transmissive member by a cavity when in a first operative position.

19. The method of claim 15, wherein the determining step comprises inputting data from the light sensor and executing comparative process to determine if the occlusion exists.

20. The method of claim 15, further comprising activated 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.

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

activating a light emitter arranged in a controller housing of a controller device to direct light outside of the controller housing and into a light transmissive member of a cap component of a pump device that is removably attached to the controller housing to provide an electrical connection between the pump device and the controller device, wherein the cap component covers an opening to an internal space of the pump device after a medicine cartridge is received in the internal space;

receiving signals from a light sensor arranged in the controller 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 of the cap component of the 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.

17. The method of claim 16, 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.