Disposable, wearable insulin dispensing device, a combination of such a device and a programming controller and a method of controlling the operation of such a device

• US 7,785,288 B2
• Filed: 06/21/2005
• Issued: 08/31/2010
• Est. Priority Date: 12/23/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc
• Inventors: Lyngsie, Michael Gorm, Mernøe, Morten
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US11/157,479
• Publication Number:
  US 20050273059A1
• Time in Patent Office: 1,897 Days
• Field of Search: 604/131, 604 65- 67, 604/890.1, 128 65- 67
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/3109 Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
• 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 2202/04 Liquids
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

A disposable, wearable, self-contained insulin dispensing device includes a housing and an insulin source in the housing that is connected to a catheter for injecting insulin into a user. The catheter projects generally perpendicularly to a generally planar surface of the housing configured for abutting a skin surface of the user; which planar surface includes an adhesive layer for adhering the housing surface to the skin surface. A removable release sheet covers the adhesive layer for protecting the adhesive layer prior to use of the device. The release sheet is provided with a catheter protection element to enclose and protect an end portion of the catheter, such that removal of the release sheet for exposing the adhesive layer also exposes the end portion. A pump in the housing includes an actuator employing a shape memory alloy wire.

Claims

1. A medicine dispensing device, comprising:

a disposable and wearable pump housing that defines a space to receive a medicine carpule;

a flexible piston rod movably arranged in the housing to adjust from a curved configuration to a rigid configuration so as to dispense medicine from the carpule when the carpule is received in the pump housing;

a drive actuator to advance the flexible piston rod toward the medicine carpule when the medicine carpule is received in the pump housing; and

a control circuit to communicate control signals to the drive actuator to cause the dispensation of the medicine, the control circuit including a programmable unit that is programmed to react to user input information indicating a blood glucose level of a user and the intake of nutrients by the user.

2. The device of claim 1, further comprising a catheter to communicate the medicine dispensed from the carpule into the user.

3. The device of claim 2, wherein the catheter projects generally perpendicular to a generally planar surface of the pump housing, further comprising an adhesive layer coupled to the generally planar surface of the pump housing to adhere the pump housing to skin of the user.

4. The device of claim 3, further comprising a removable release sheet to cover the adhesive layer, the release sheet including a catheter protection structure that at least partially encloses an end portion of the catheter when the release sheet covers the adhesive layer.

5. The device of claim 1, wherein the drive actuator comprises a shape memory alloy wire that changes length in response to heat.

6. The device of claim 1, wherein the drive actuator comprises a gear wheel, a pawl arranged to engage at least one tooth of the gear wheel, and a spring device coupled to the pawl so as to urge the pawl to rotate the gear wheel.

7. The device of claim 6, wherein the control circuit communicates the control signals according to a program that indicates a sequence of a particular amount of actuations of the drive actuator over a period of time.

8. The device of claim 7, wherein the program indicates a sequence of actuations of the drive actuator that varies according to the time of day.

9. The device of claim 7, wherein the program is stored in the programmable unit of the control circuit, the program being alterable by user input on an input device.

10. The device of claim 9, wherein the input device provides the user input information indicating the blood glucose level of the user and the intake of nutrients by the user.

11. The device of claim 10, wherein the input device comprises one or more buttons and a display screen.

12. The device of claim 9, wherein the input device comprises at least one of a cellular phone device, a personal computer device, a laptop computer device, or a handheld computer device.

13. The device of claim 6, wherein the flexible piston rod comprises rod segments connected in series by hinge elements, each of the rod segments having exterior threads extending from an outer cylindrical surface.

14. The device of claim 13, wherein the exterior threads of the rod segments cooperate with corresponding interior screw threads of a portion of the drive actuator.

15. The device of claim 6, further comprising a button interface associated with the pump housing that is configured to activate a bolus operation for dispensing the medicine from the carpule.

16. The device of claim 6, wherein the medicine is insulin.

17. The device of claim 1, wherein the programmable unit of the control circuit automatically alters the dispensation of the medicine in response to the user input information indicating the blood glucose level of the user and the intake of nutrients by the user.

18. The device of claim 17, wherein the user input information that indicates the intake of nutrients by the user includes information of constitution of a meal.

19. The device of claim 1, wherein the control circuit communicates the control signals according to a program that indicates a sequence of a particular amount of actuations of the drive actuator over a period of time.

20. The device of claim 19, wherein the program indicates a sequence of actuations of the drive actuator that varies according to the time of day.

21. The device of claim 19, wherein the program is stored in the programmable unit of the control circuit, the program being alterable by user input on an input device.

22. The device of claim 21, wherein the input device provides the user input information indicating the blood glucose level of the user and the intake of nutrients by the user.

23. The device of claim 21, wherein the input device comprises one or more buttons and a display screen.

24. The device of claim 21, wherein the input device comprises at least one of a cellular phone device, a personal computer device, a laptop computer device, or a handheld computer device.

25. The device of claim 1, wherein the flexible piston rod comprises rod segments connected in series by hinge elements, the rod segments having exterior threads on at least a portion of an outer surface.

26. The device of claim 25, wherein the exterior threads of the rod segments cooperate with corresponding screw threads of the drive actuator.

27. The device of claim 25, wherein the rod segments and hinge elements are integrally molded from a plastic material.

28. The device of claim 1, further comprising a button interface associated with the pump housing that is configured to activate a bolus operation for dispensing the medicine from the carpule.

29. The device of claim 1, wherein the pump housing is water-tight when the carpule is received in the is received in the pump housing.

30. The device of claim 1, wherein the medicine is insulin.

31. A medicine dispensing device, comprising:

a disposable and wearable pump housing that defines a space to receive a carpule containing insulin medicine;

a flexible piston rod movably arranged in the housing to adjust from a curved configuration to a rigid configuration so as to dispense medicine from the carpule when the carpule is received in the pump housing, the flexible piston rod comprising rod segments connected in series by hinge elements, the rod segments having exterior threads on at least a portion of an outer surface;

a drive actuator to advance the flexible piston rod toward the carpule when the carpule is received in the pump housing, wherein the drive actuator comprises a gear wheel, a pawl arranged to engage at least one tooth of the gear wheel, and a spring device coupled to the pawl so as to urge the pawl to rotate the gear wheel, wherein the exterior threads of the rod segments of the flexible piston rod cooperate with interior screw threads of the drive actuator; and

a control circuit to communicate control signals to the drive actuator to cause the dispensation of the medicine, the control circuit including a programmable unit that is programmed to react to user input information indicating a blood glucose level of a user and the intake of nutrients by the user,

wherein the control circuit communicates the control signals according to a program that indicates a sequence of a particular amount of actuations of the drive actuator that varies according to the time of day, the program being stored in the programmable unit of the control circuit and being alterable by user input on an input device.

32. The device of claim 31, further comprising a catheter to communicate the medicine dispensed from the carpule into the user.

33. The device of claim 32, wherein the catheter projects generally perpendicular to a generally planar surface of the pump housing, further comprising an adhesive layer coupled to the generally planar surface of the pump housing to adhere the pump housing to skin of the user.

34. The device of claim 33, further comprising a removable release sheet to cover the adhesive layer, the release sheet including a catheter protection structure that at least partially encloses an end portion of the catheter when the release sheet covers the adhesive layer.

35. The device of claim 31, wherein the drive actuator comprises a shape memory alloy wire that changes length in response to heat.

36. The device of claim 31, wherein the programmable unit of the control circuit automatically alters the dispensation of the medicine in response to the user input information indicating the blood glucose level of the user and the intake of nutrients by the user.

37. The device of claim 36, wherein the user input information that indicates the intake of nutrients by the user includes information of constitution of a meal.

38. The device of claim 31, wherein the input device provides the user input information indicating the blood glucose level of the user and the intake of nutrients by the user.

39. The device of claim 31, wherein the input device comprises one or more buttons and a display screen.

40. The device of claim 31, wherein the input device comprises at least one of a cellular phone device, a personal computer device, a laptop computer device, or a handheld computer device.

41. The device of claim 31, wherein the rod segments and hinge elements are integrally molded from a plastic material.

42. The device of claim 31, further comprising a button interface associated with the pump housing that is configured to activate a bolus operation for dispensing the insulin from the carpule.

43. The device of claim 31, wherein the pump housing is water-tight when the carpule is received in the is received in the pump housing.