Occlusion sensing system for infusion pumps

• US 7,828,528 B2
• Filed: 09/06/2007
• Issued: 11/09/2010
• Est. Priority Date: 09/06/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc
• Inventors: Wenger, Mitchell, Estes, Mark C., Sadler, John W.
• Primary Examiner(s): Kramer; Devon C
• Assistant Examiner(s): LETTMAN, BRYAN MATTHEW
• Application Number:
  US11/851,212
• Publication Number:
  US 20090067989A1
• Time in Patent Office: 1,160 Days
• Field of Search: 417/43, 417/53, 417/300, 604/67, 604/890.1
• US Class Current: 417/43
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• 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 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01P 13/0013 by using a solid body which is shifted by the action of the fluid
• CPC Class Codes: G01P 13/004 by using the rotation of vanes
• CPC Class Codes: G01P 13/0073 by using vibrations generated by the fluid

Abstract

Some embodiments of an infusion pump system may include an occlusion sensor system that communicates with control circuitry to detect the presence of an occlusion. In some embodiments, the occlusion sensor system includes first components that are located within a disposable and non-reusable pump device, and second components that are located within a reusable controller device, the second components being in operable communication with the first components to determine whether a fluid is flowing from the pump device.

Claims

1. A portable infusion pump system, comprising:

a pump device including a pump housing that defines a space to receive a medicine, a separable cap device that mates with the pump housing to cover the space that receives the medicine, and a drive system arranged in the pump housing to dispense the medicine through a medicine flow path, wherein the cap device is matable with an infusion set having a length of flexible tubing;

a controller device that is removably attachable to the pump device, the controller device including a controller housing and control circuitry that communicates with the drive system of the pump device; and

an occlusion sensor system that communicates with the control circuitry to detect the presence of an occlusion in the medicine flow path, comprising;

a flow-responsive component arranged within a flow chamber of the cap device of the pump device, the flow-responsive component moving in the flow chamber in response to medicine flow through the flow chamber and acting on the flow-responsive component; and

a sensor circuit at least partially disposed within the controller device, the sensor circuit being arranged in the controller housing and adjacent to the cap device of the pump device so as to detect movement of the flow-responsive component to a first position while the controller device is removably attached to the pump device and the drive system in the pump housing urges medicine through the medicine flow path, the sensor circuit communicating a signal to the control circuitry in response to the movement of the flow-responsive component to the first position.

2. The pump system of claim 1, wherein the flow-responsive component includes at least one sensor body that is movable by the medicine flowing from the pump device.

3. The pump system of claim 2, wherein the sensor circuit monitors a magnetic field that is generated by the at least one sensor body.

4. The pump system of claim 2, wherein the sensor circuit monitors pressure waves generated by the at least one sensor body.

5. The pump system of claim 2, wherein the sensor circuit optically monitors a position of the at least one sensor body.

6. The pump system of claim 1, wherein the flow-responsive component includes an impeller that is rotatably supported within the flow chamber.

7. The pump system of claim 6, wherein the sensor circuit includes a sensor to detect movement of the impeller, the sensor comprising one of an optical sensor, an electromagnetic sensor and an acoustical sensor.

8. The pump system of claim 1, wherein the flow-responsive component includes at least one resonant structure that oscillates when the medicine flows through the flow chamber of the pump device.

9. The pump system of claim 8, wherein the sensor circuit includes a sensor to detect movement of the resonant structure, the sensor comprising one of an optical sensor, an electromagnetic sensor and an acoustic sensor.

10. A method of monitoring a wearable infusion pump system for occlusions, the method comprising:

preparing a pump device for use with a controller device, the pump device including a pump housing that encloses at least an actuator portion of a drive system to dispense medicine from the pump device and a cap device that mates with the pump housing to cover a space that receives the medicine, the controller device including a controller housing and control circuitry to communicate control signals to the actuator portion of the drive system within the pump housing of the pump device;

removably attaching the pump device with the controller device so that a first electrical connector of the pump device engages a second electrical connector of the controller device;

aligning a flow-responsive component of an occlusion sensor system with a sensor circuit of the occlusion sensor system, the flow-responsive component being movable within a flow chamber of the cap device of the pump device and the sensor circuit being arranged in the controller housing and adjacent to the pump device so as to detect movement of the flow-responsive component to a first position within the pump device while the drive system in the pump housing urges medicine through the flow chamber of the pump device; and

activating the occlusion sensor system to determine if the medicine is flowing from the pump device.

11. The method of claim 10, further comprising generating an alert of an occlusion in a medicine flow path when the occlusion sensor system indicates a lack of medicine flow from the pump device.

12. The method of claim 10, wherein the flow-responsive component comprises at least one sensor body within a medicine flow path of the pump device, wherein the at least one sensor body moves in response to the medicine flowing through the chamber.

13. The method of claim 12, further comprising monitoring a magnetic field that is generated by the at least one sensor body using the sensor circuit.

14. The method of claim 12, further comprising monitoring pressure waves generated by the at least one sensor body using the sensor circuit.

15. The method of claim 12, further comprising optically monitoring a position of the at least one sensor body using the sensor circuit.

16. The method of claim 10, further comprising biasing the flow-responsive component against a flow direction of the medicine using a biasing member that exerts a biasing force on the flow-responsive component.

17. The method of claim 10, wherein the flow-responsive component includes an impeller that is rotatably supported within the flow chamber.

18. The method of claim 17, wherein the sensor circuit includes one of an optical sensor, an electromagnetic sensor and an acoustical sensor that monitors rotation of the impeller.

19. The method of claim 14, wherein the flow-responsive component includes at least one resonant structure that oscillates when medicine flows through the chamber.

20. The method of claim 19, wherein the sensor circuit includes one of an optical sensor, an electromagnetic sensor and an acoustical sensor that monitors movement of the resonant structure.

21. A portable and wearable infusion pump assembly, comprising:

a disposable and non-reusable pump device including;

a drive system to dispense a medicine from the pump device, a pump housing to enclose at least a portion of the drive system, a separable cap device that mates with the pump housing to cover a space that receives the medicine, and a first electrical connector that is externally accessible along the pump housing;

a reusable controller device removably attached to the pump device, the controller device including;

a user interface having a display device and at least one button, control circuitry to communicate with the drive system of the pump device, a controller housing to enclose at least a portion of the control circuitry, and a second electrical connector is engaged with the first connector to provide electrical communication between the control circuitry and the drive system; and

an occlusion sensor system that communicates with the control circuitry to detect the presence of an occlusion in a medicine flow path, the occlusion sensor system comprising;

a flow-responsive component arranged within a flow chamber of the separable cap device of the pump device, the flow-responsive component moving in the flow chamber in response to medicine flow through the flow chamber and acting on the flow-responsive component; and

a sensor circuit at least partially disposed within the controller device, the sensor circuit being arranged to detect movement of the flow-responsive component to a first position, the sensor circuit communicating a signal to the control circuitry in response to the movement of the flow-responsive component to the first position.

22. The infusion pump assembly of claim 21, wherein the flow-responsive component includes at least one sensor body positioned in the separable cap device of the pump device, and the sensor circuit includes one of an optical sensor, an electromagnetic sensor and an acoustical sensor that is mounted to the controller housing and that monitors movement of the at least one sensor body.

23. The infusion pump assembly of claim 21, wherein the flow-responsive component includes an impeller that is rotatably supported within the flow chamber, and the sensor circuit includes one of an optical sensor, an electromagnetic sensor and an acoustical sensor that monitors rotation of the impeller.

24. The infusion pump assembly of claim 21, wherein the flow-responsive component includes at least one resonant structure that oscillates when fluid flows through the flow chamber, and the sensor circuit includes one of an optical sensor, an electromagnetic sensor and an acoustical sensor that monitors movement of the at least one resonant structure.

25. A wearable infusion pump system, comprising:

a disposable and non-reusable pump device including a drive system to dispense medicine from the pump device and a cap device to cover a space that receives the medicine, the controller device including a first electrical connector that is externally accessible;

a reusable controller device removably attachable to the disposable and non-reusable pump device, the controller device including a second electrical connector that is engageable with the first connector to provide electrical communication between control circuitry of the controller device and the drive system of the pump device; and

an occlusion sensor system that communicates with the control circuitry to detect the presence of an occlusion in a medicine flow path, the occlusion sensor system comprising;

an obstruction member arranged in a stationary position within a flow chamber of the cap device of the pump device, the obstruction member remaining stationary in a medicine flow path to generate disturbances within the medicine flow path in response to medicine flow through the flow chamber; and

a sensor circuit at least partially disposed within the controller device, the sensor circuit being arranged to detect the disturbances in the medicine flow path, the sensor circuit communicating a signal to the control circuitry in response to the disturbances.

26. The system of claim 25, wherein the obstruction member comprises at least one wall member is disposed within the flow chamber that remains generally stationary in the flow chamber, wherein the obstruction member and the flow chamber are positioned within the cap device of the pump device.

27. The system of claim 26, wherein the at least one wall member generates the disturbances including vortices or turbulence within the flow chamber in response to the drive system in the pump housing urges medicine through the flow chamber of the pump device.

28. The system of claim 27, wherein the sensor circuit acoustically monitors the disturbances in the medicine flow path.

29. The system of claim 25, wherein the obstruction member comprises a resonant structure that is supported along the medicine flow path within the flow chamber.

30. The system of claim 29, wherein medicine flow through the flow chamber induces vibration of the resonant structure, and the sensor circuit monitors the vibration of the resonant structure.