Controlled adjustment of medicine dispensation from an infusion pump device

• US 7,879,026 B2
• Filed: 09/07/2007
• Issued: 02/01/2011
• Est. Priority Date: 09/07/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc
• Inventors: Estes, Mark C., Causey, James
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US11/851,898
• Publication Number:
  US 20090069784A1
• Time in Patent Office: 1,243 Days
• Field of Search: 604/890.1, 604/891.1
• US Class Current: 604/890.1
• 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 2205/332 Force measuring means
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Some embodiments of an infusion pump system can incorporate an accelerometer or other motion sensor to detect the user'"'"'s activity level. If the user'"'"'s activity level indicates that he or she is exercising or otherwise at an elevated level, the infusion pump device can be configured to automatically adjust the dispensation rate of a medicine such as insulin. Accordingly, an insulin delivery rate can be corrected to account for a user'"'"'s activity level (e.g., an elevated activity level during exercise or the like).

Claims

1. A portable and wearable insulin pump system, comprising:

a disposable and non-reusable pump device having a drive system to dispense insulin, the pump device including;

a pump housing that defines a space to receive an insulin cartridge, a cap device that connects with the pump housing to enclose the insulin cartridge in the pump housing when the insulin cartridge is received in the space, and a retainer structure that is different from the cap device and that extends into the space to engage a portion of the medicine cartridge and thereby hinder removal of the insulin cartridge when the insulin cartridge is received in the space such that the insulin cartridge is non-removable from the disposable and non-reusable pump device;

a reusable controller device removably attached to the pump device and being different from the cap device of the pump device, the controller device including;

a controller housing matable with the pump housing structure to form a releasable mechanical connection, control circuitry positioned in the controller housing that electrically transmits control signals to the drive system positioned in the pump housing to dispense insulin at a dispensation rate when the controller device is removably attached to the pump device, the controller device including a user interface; and

an accelerometer arranged in controller housing of the reusable controller device and electrically connected to the control circuitry such that the accelerometer is external to the pump housing of the pump device, the accelerometer providing signals indicative of activity levels of the user;

wherein the controller device automatically adjusts the dispensation rate based at least in part on the signals of the accelerometer indicative of the activity levels of the user, and

wherein the controller device automatically reduces a basal rate of insulin if signals of the accelerometer indicate an increased activity level.

2. The system of claim 1, wherein the controller device automatically increases a basal rate of insulin if signals of the accelerometer indicate a decreased activity level.

3. The system of claim 1, wherein the retainer structure that is different from the cap device comprises one or more retainer wings that engaged the insulin cartridge when the insulin cartridge is received in the space.

4. The system of claim 3, wherein the one or more retainer wings hinder removal of the insulin cartridge and prevent reuse of the pump device with a new insulin cartridge when the insulin cartridge is received in the space.

5. The system of claim 4, wherein the one or more retainer wings engaged a neck portion of the insulin cartridge when the insulin cartridge is received in the space.

6. The system of claim 1, wherein the insulin cartridge and the pump device with a new insulin cartridge are a one-time-use apparatus when the insulin cartridge is received in the space.

7. The system of claim 1, wherein the cap device that connects with the pump housing pierces a septum of the insulin cartridge when the insulin cartridge is received in the space defined by the pump housing.

8. The system of claim 7, wherein the cap device seals the insulin cartridge in the space defined by the pump housing when the insulin cartridge is received in the space defined by the pump housing.

9. The system of claim 8, wherein the cap device is configured to mate with an infusion set having a flexible tube and a subcutaneous cannula.

10. The system of claim 9, further comprising a ring seal member between the cap device and the pump housing.

11. The system of claim 1, wherein the disposable and non-reusable pump device comprises a first disposable and non-reusable pump device, the system further comprising a second disposable and non-reusable pump device that is similar in shape and size to first disposable and non-reusable pump device, wherein the second disposable and non-reusable pump device is removably attachable to the reusable controller device when the first disposable and non-reusable pump device is detached and discarded.

12. The system of claim 11, wherein the disposable and non-reusable pump device is a single-use device that is discarded with the insulin cartridge after exhaustion of the insulin cartridge.

13. The system of claim 12, wherein user interface of the controller device includes a single display device that is the only display device of the system.

14. The system of claim 1, wherein the automatic adjustment of insulin delivery is based on an integration of detected activity levels over a recent period of about 3 minutes to about 30 minutes.

15. The system of claim 1, wherein the pump device includes a first electrical connector along an exterior face of the pump housing, and the controller device includes a second electrical connector along an exterior face of the controller housing that opposes the exterior face of the pump housing, and wherein the first and second electrical connectors provide electrical communication between the control circuitry positioned in the controller housing and an electrically powered mechanical actuator of the drive system positioned in the pump housing.

16. The system of claim 15, wherein the control circuitry positioned in the controller housing electrically transmits control signals directly to the electrically powered mechanical actuator of the drive system to dispense insulin at the dispensation rate when the controller device is removably attached to the pump device.

17. The system of claim 1, wherein when the reusable controller device is removably attached to the disposable and non-reusable pump device, the system is sized to be worn in a clothing pocket while dispensing insulin.

18. The system of claim 1, wherein when the reusable controller device is removably attached to the disposable and non-reusable pump device, the system is sized to be adhered to a skin surface while dispensing insulin.

19. The system of claim 1, wherein the accelerometer is mounted to a main processor board of the control circuitry positioned in the controller housing such that the accelerometer is positioned external to the pump housing that contains the drive system and the space to receive the insulin cartridge.

20. The system of claim 19, wherein the control circuitry positioned in the controller housing includes a processor while the disposable and non-reusable pump device is free of a processor.

21. The system of claim 20, wherein the disposable and non-reusable pump device includes a connector circuit that operates as passageway for control signals transmitted from the control circuitry positioned in the controller housing to the actuator of the drive system positioned in the pump housing.

22. The system of claim 20, wherein the control circuitry positioned in the controller housing is electrically connected to user interface components mounted to the controller housing while the disposable and non-reusable pump device is free of user interface components.

23. The system of claim 1, wherein the pump housing contains a first power source and the controller housing contains a second power source that is different from the first power source.

24. The system of claim 1, wherein the pump housing defines the space to receive the insulin cartridge as a cavity that extends in a longitudinal direction inside the pump housing.

25. The system of claim 24, wherein the pump device is removably attached to the controller device by guided movement of the pump device relative to the controller device in the longitudinal direction.

26. The system of claim 1, further comprising a second disposable and non-reusable pump device having a shape similar to the first disposable and non-reusable pump device, and the second disposable and non-reusable pump device defining a space to receive a second insulin cartridge.

27. The system of claim 26, wherein the second disposable and non-reusable pump device is removably attachable to the reusable controller device in a fixed relationship when the first disposable and non-reusable pump device is removed from the reusable controller device, the control circuitry of the reusable controller device communicating control signals to a drive system of the second disposable and non-reusable pump device when the reusable controller device is removably attached to the second disposable and non-reusable pump device.

28. The system of claim 27, wherein the reusable controller device automatically reduces a basal rate of insulin dispensed from the second disposable and non-reusable pump device if signals of the accelerometer indicate an increased activity level.

29. The system of claim 28, wherein the controller device automatically increases a basal rate of insulin dispensed from the second disposable and non-reusable pump device if signals of the accelerometer indicate a decreased activity level.

30. The system of claim 1, wherein the controller device automatically adjusts the dispensation rate of insulin dispensed from the disposable and non-reusable pump device without instructional user input.

31. The system of claim 30, wherein the controller device communicates to the user via the user interface when the dispensation rate of insulin dispensed from the disposable and non-reusable pump device is automatically adjusted.

32. A portable and wearable insulin pump system, comprising:

a disposable and non-reusable pump device having a drive system to dispense insulin, the pump device including;

a pump housing that defines a space to receive an insulin cartridge, and a cap device that connects with the pump housing to enclose the insulin cartridge in the pump housing when the insulin cartridge is received in the space;

a reusable controller device removably attached to the pump device and being different from the cap device of the pump device, the controller device including;

a controller housing matable with the pump housing structure to form a releasable mechanical connection, control circuitry positioned in the controller housing that communicates control signals to the drive system to dispense insulin at a dispensation rate when the controller device is removably attached to the pump device, the controller device including a user interface; and

an accelerometer arranged in the controller housing of the reusable controller device and electrically connected to the control circuitry, the accelerometer providing signals indicative of activity levels of the user;

wherein the controller device automatically adjusts the dispensation rate based at least in part on the signals of the accelerometer indicative of the activity levels of the user,

wherein the automatic adjustment of insulin delivery is based on an integration of detected activity levels over a recent period of about 3 minutes to about 30 minutes.

33. The system of claim 32, wherein the controller device automatically adjusts the dispensation rate without instructional input from the user.

34. The system of claim 32, wherein the controller device communicates to the user via the user interface when the dispensation rate is automatically adjusted.

35. The system of claim 34, wherein the user interface comprises a display device and one or more buttons for actuation by the user.

36. The system of claim 35, wherein the controller device communicates to the user via the display device to notify the user that the dispensation rate was automatically adjusted.

37. The system of claim 32, wherein the disposable and non-reusable pump device includes a retainer structure that is different from the cap device and that extends into the space to engage a portion of the medicine cartridge and thereby hinder removal of the insulin cartridge when the insulin cartridge is received in the space such that the insulin cartridge is non-removable from the disposable and non-reusable pump device.

38. The system of claim 32, wherein the retainer structure that is different from the cap device comprises one or more retainer wings that engaged the insulin cartridge when the insulin cartridge is received in the space.

39. The system of claim 38, wherein the one or more retainer wings hinder removal of the insulin cartridge and prevent reuse of the pump device with a new insulin cartridge when the insulin cartridge is received in the space.

40. The system of claim 39, wherein the one or more retainer wings engaged a neck portion of the insulin cartridge when the insulin cartridge is received in the space.

41. The system of claim 32, wherein the cap device that connects with the pump housing pierces a septum of the insulin cartridge when the insulin cartridge is received in the space defined by the pump housing.

42. The system of claim 41, wherein the cap device seals the insulin cartridge in the space defined by the pump housing when the insulin cartridge is received in the space defined by the pump housing.

43. The system of claim 42, wherein the cap device is configured to mate with an infusion set having a flexible tube and a subcutaneous cannula.

44. The system of claim 43, further comprising a ring seal member between the cap device and the pump housing.

45. The system of claim 32, wherein the disposable and non-reusable pump device comprises a first disposable and non-reusable pump device, the system further comprising a second disposable and non-reusable pump device that is similar in shape and size to first disposable and non-reusable pump device, wherein the second disposable and non-reusable pump device is removably attachable to the reusable controller device when the first disposable and non-reusable pump device is detached and discarded.

46. The system of claim 45, wherein the disposable and non-reusable pump device is a single-use device that is discarded with the insulin cartridge after exhaustion of the insulin cartridge.

47. The system of claim 46, wherein user interface of the controller device includes a single display device that is the only display device of the system.

48. The system of claim 32, wherein the pump device includes a first electrical connector along an exterior face of the pump housing, and the controller device includes a second electrical connector along an exterior face of the controller housing that opposes the exterior face of the pump housing, and wherein the first and second electrical connectors provide electrical communication between the control circuitry positioned in the controller housing and an electrically powered mechanical actuator of the drive system positioned in the pump housing.

49. The system of claim 48, wherein the control circuitry positioned in the controller housing electrically transmits control signals directly to the electrically powered mechanical actuator of the drive system to dispense insulin at the dispensation rate when the controller device is removably attached to the pump device.

50. The system of claim 32, wherein when the reusable controller device is removably attached to the disposable and non-reusable pump device, the system is sized to be worn in a clothing pocket while dispensing insulin.

51. The system of claim 32, wherein when the reusable controller device is removably attached to the disposable and non-reusable pump device, the system is sized to be adhered to a skin surface while dispensing insulin.

52. The system of claim 32, wherein the accelerometer is mounted to a main processor board of the control circuitry positioned in the controller housing such that the accelerometer is positioned external to the pump housing that contains the drive system and the space to receive the insulin cartridge.

53. The system of claim 52, wherein the control circuitry positioned in the controller housing includes a processor while the disposable and non-reusable pump device is free of a processor.

54. The system of claim 53, wherein the disposable and non-reusable pump device includes a connector circuit that operates as passageway for control signals transmitted from the control circuitry positioned in the controller housing to the actuator of the drive system positioned in the pump housing.

55. The system of claim 54, wherein the control circuitry positioned in the controller housing is electrically connected to user interface components mounted to the controller housing while the disposable and non-reusable pump device is free of user interface components.