Device and method employing shape memory alloy

• US 8,172,800 B2
• Filed: 09/23/2009
• Issued: 05/08/2012
• Est. Priority Date: 10/09/2002
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Rush, Benjamin M., Reggiardo, Christopher V.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): FLICK, JASON E
• Application Number:
  US12/565,146
• Publication Number:
  US 20100049132A1
• Time in Patent Office: 958 Days
• Field of Search: 604/67
• US Class Current: 604/152
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/0288 Electro-rheological or magneto-rheological materials
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: F04B 2205/09 Flow through the pump
• CPC Class Codes: F04B 43/043 Micropumps
• CPC Class Codes: F04B 49/065 and making use of computers
• CPC Class Codes: F04B 51/00 Testing machines, pumps, or pumping installations
• CPC Class Codes: F05C 2251/08 Shape memory
• CPC Class Codes: G01F 1/64 by measuring electrical currents passing through the fluid flow; measuring electrical potential generated by the fluid flow, e.g. by electrochemical, contact or friction effects G01F1/58 takes precedence
• CPC Class Codes: G01F 1/708 Measuring the time taken to traverse a fixed distance
• CPC Class Codes: G01F 1/7088 using electrically charged particles as tracers
• CPC Class Codes: G01F 25/10 of flowmeters

Abstract

A system for the metering and delivery of small discrete volumes of liquid is comprised of a small or minimal number of inexpensive components. One such component is a movable member, such as a miniature precision reciprocating displacement pump head, which is driven by an actuator that comprises a shape memory alloy material. The operating mechanism of the system is of little or minimal complexity. The system facilitates the precise metering and delivery of the small discrete volumes of liquid. Potential applications for the system include subcutaneous, long-term, automated drug delivery, for example, the delivery of insulin to a person with diabetes. In such an application, the small, simple and inexpensive nature of the invention would allow for its use as both a portable and a disposable system.

Claims

1. A medical device for pumping a fluid, comprising:

a plunger having a shaft sized for slidable movement through a rigid restraint;

a piston attached to the plunger shaft and configured for reciprocal movement in a displacement cavity between a first projection and a second projection extending outwardly from a cavity wall;

an inlet conduit spaced apart from the piston and in fluid communication with the displacement cavity;

a shape memory alloy wire attached to the plunger for pulling the plunger in a first direction relative to the displacement cavity;

a digital timing circuit for activating the shape memory alloy wire including a capacitor for providing electrical energy to the shape memory alloy wire; and

an insulin reservoir containing insulin and being in fluid communication with the displacement cavity via the inlet conduit so that as the shape memory alloy wire is activated the wire shortens and pulls the plunger in the first direction thereby drawing a predetermined volume of insulin from the reservoir into the displacement cavity.

2. The medical device of claim 1, wherein the electrical energy heats the shape memory alloy wire to a transitional temperature thereby causing the wire to shorten.

3. The medical device of claim 2, wherein the piston moves to the first projection corresponding to a maximum volume within the displacement cavity.

4. The medical device of claim 2, wherein the shape memory alloy wire cools and a biasing spring associated with the wire moves the piston to the second projection corresponding to the minimum volume within the displacement cavity.

5. The medical device of claim 1, wherein the digital timing circuit is programmable.

6. The medical device of claim 1, wherein the capacitor is an electrochemical capacitor having a high capacitance and low-equivalent series resistance.

7. The medical device of claim 1, wherein the rate of insulin delivery is controlled by varying the period of time between actuations of the shape memory alloy wire.

8. The medical device of claim 1, wherein a portion of the fluid pumping device is disposable with the exception of the electronics including the digital timing circuit and the shape memory alloy wire.

9. The medical device of claim 1, wherein the insulin reservoir is collapsible.

10. The medical device of claim 1, wherein the fluid pumping device includes an electrical energy source.

11. The medical device of claim 10, wherein the electrical energy source is a replaceable battery.

12. The medical device of claim 11, wherein the battery is electrically connected to the shape memory alloy wire.

13. The medical device of claim 12, wherein the battery provides electrical energy to the capacitor.

14. The medical device of claim 13, wherein the capacitor is connected in parallel with the battery.

15. The medical device of claim 14, wherein electrical energy is supplied to the shape memory wire in part from the capacitor due to the substantially lower equivalent series resistance as compared to the battery.

16. The medical device of claim 1, wherein a battery provides electrical energy to the digital timing circuit.

17. The medical device of claim 1, wherein the timing circuit is a programmable digital timing circuit.

18. The medical device of claim 17, wherein the timing circuit includes a transistor switch.

19. The medical device of claim 13, wherein the battery and the capacitor are connected to each other in parallel and are connected to the shape memory alloy wire through a transistor switch.

20. The medical device of claim 19, wherein the battery charges the capacitor with electrical energy when the transistor switch is open.

21. The medical device of claim 20, wherein the capacitor provides electrical energy to the shape memory alloy wire when the transistor switch is closed.

22. The medical device of claim 1, wherein the shape memory alloy wire is up to 40 mm long.

23. The medical device of claim 1, wherein the shape memory alloy wire is 125 microns in diameter.

24. The medical device of claim 1, wherein the plunger pumps 0.1 microliter of insulin into a patient per each cycle of the pumping device.

25. The medical device of claim 24, wherein the insulin pumping device has an effective maximum of 3000 cycles.

26. The medical device of claim 1, wherein the timing circuit generates an electrical pulse duration lasting about 0.15 seconds.

27. A medical device for pumping a fluid, comprising:

a plunger having a shaft sized for slidable movement in a restraint;

a piston attached to the plunger and configured for reciprocal movement in a tubular-shaped displacement cavity between a first projection and a second projection extending outwardly from a cavity wall;

an inlet conduit spaced apart from the piston and in fluid communication with the displacement cavity;

a shape memory alloy wire attached to the plunger for moving the plunger in a first direction relative to the displacement cavity;

a digital timing circuit for activating the shape memory alloy wire including a capacitor for providing electrical energy to the shape memory alloy wire; and

an insulin reservoir containing insulin and being in fluid communication with the displacement cavity via the inlet conduit so that as the shape memory alloy wire is activated the wire shortens and pulls the plunger in the first direction thereby drawing a predetermined volume of insulin from the reservoir into the tubular-shaped displacement cavity.

28. The medical device of claim 27, wherein the electrical energy heats the shape memory alloy wire to a transitional temperature thereby causing the wire to shorten.

29. The medical device of claim 28, wherein the piston moves to the first projection corresponding to a maximum volume within the tubular-shaped displacement cavity.

30. The medical device of claim 28, wherein the shape memory alloy wire cools and a biasing spring associated with the wire moves the piston to the second projection corresponding to the minimum volume within the tubular-shaped displacement cavity.

31. The medical device of claim 27, wherein the digital timing circuit is programmable.

32. The medical device of claim 27, wherein the capacitor is an electrochemical capacitor having a high capacitance and low-equivalent series resistance.

33. An insulin pump, comprising:

a plunger having a shaft sized for slidable movement in a rigid restraint;

a piston attached to the plunger and configured for reciprocal movement in a displacement cavity between a first projection and a second projection extending outwardly from a cavity wall;

an inlet conduit spaced apart from the piston and in fluid communication with the displacement cavity;

a shape memory alloy wire attached to the plunger for pulling the plunger in a first direction relative to the displacement cavity;

a digital timing circuit for activating the shape memory alloy wire including a battery for providing electrical energy to the shape memory alloy wire; and

an insulin reservoir containing insulin and being in fluid communication with the displacement cavity via the inlet conduit so that as the shape memory alloy wire is activated the wire shortens and pulls the plunger in the first direction thereby drawing a predetermined volume of insulin from the reservoir into the displacement cavity.

34. The medical device of claim 33, wherein the electrical energy heats the shape memory alloy wire to a transitional temperature thereby causing the wire to shorten.

35. The medical device of claim 34, wherein the piston moves to the first projection corresponding to a maximum volume within the displacement cavity.

36. The medical device of claim 34, wherein the shape memory alloy wire cools and a biasing spring associated with the wire moves the piston to the second projection corresponding to the minimum volume within the displacement cavity.

37. The medical device of claim 33, wherein the digital timing circuit is programmable.

38. The medical device of claim 33, wherein the battery is electrically connected to a capacitor.

39. The medical device of claim 38, wherein the capacitor is an electrochemical capacitor having a high capacitance and low-equivalent series resistance.

40. The medical device of claim 38, wherein the battery is connected in parallel to the capacitor.

41. The medical device of claim 40, wherein the capacitor is electrically connected to the shape memory alloy wire.

42. The medical device of claim 41, wherein the capacitor provides electrical energy to the shape memory alloy wire.

43. The medical device of claim 33, wherein the battery provides electrical energy to the timing circuit.

44. The medical device of claim 38, wherein the timing circuit is a programmable digital timing circuit.

45. The medical device of claim 44, wherein the timing circuit includes a transistor switch.

46. The medical device of claim 38, wherein the battery and the capacitor are connected to each other in parallel and are connected to the shape memory alloy wire through a transistor switch.

47. The medical device of claim 46, wherein the battery charges the capacitor with electrical energy when the transistor switch is open.

48. The medical device of claim 47, wherein the capacitor provides electrical energy to the shape memory alloy wire when the transistor switch is closed.

49. The medical device of claim 33, wherein the shape memory alloy wire is up to 40 mm long.

50. The medical device of claim 33, wherein the shape memory alloy wire is 125 microns in diameter.

51. The medical device of claim 33, wherein the plunger pumps 0.1 microliter of insulin into a patient per each pump cycle.

52. The medical device of claim 51, wherein the insulin pump has an effective maximum of 3000 cycles.

53. The medical device of claim 33, wherein the timing circuit generates an electrical pulse duration lasting about 0.15 seconds.

54. The medical device of claim 33, wherein the rate of insulin delivery is controlled by varying the period of time between actuations of the shape memory alloy wire.

55. The medical device of claim 33, wherein a portion of the pump is disposable with the exception of the electronics including the digital timing circuit and the shape memory alloy wire.

56. An insulin pump, comprising:

a plunger attached to a piston and configured for restrained reciprocal movement in a displacement cavity between a first projection and a second projection extending outwardly from a cavity wall;

an inlet conduit spaced apart from the piston and in fluid communication with the displacement cavity;

a single length of shape memory alloy wire attached to the plunger for pulling the plunger in a first direction in the displacement cavity;

a digital timing circuit for activating the shape memory alloy wire including a power source for providing electrical energy to the shape memory alloy wire;

an insulin reservoir containing insulin and being in fluid communication with the displacement cavity via the inlet conduit so that as the shape memory alloy wire is activated the single length of wire shortens and pulls the plunger in the first direction thereby drawing a predetermined volume of insulin from the reservoir into the displacement cavity; and

cooling the shape memory alloy wire so that a biasing spring associated with the plunger lengthens the wire and moves the plunger to the second projection corresponding to the minimum volume within the displacement cavity.

57. The insulin pump of claim 56, wherein the electrical energy heats the shape memory alloy wire to a transitional temperature thereby causing the wire to shorten.

58. The insulin pump of claim 57, wherein the plunger moves to the first projection corresponding to a maximum volume within the displacement cavity.

59. The insulin pump of claim 56, wherein the digital timing circuit is programmable.

60. The insulin pump of claim 56, wherein the rate of insulin delivery is controlled by varying the period of time between actuations of the shape memory alloy wire.

61. The medical device of claim 56, wherein a portion of the insulin pump is disposable with the exception of the electronics including the digital timing circuit and the shape memory alloy wire.

62. The insulin pump of claim 56, wherein the insulin reservoir is collapsible.

63. The insulin pump of claim 56, wherein the electrical energy source is a replaceable battery.

64. The insulin pump of claim 63, wherein the battery is electrically connected to the shape memory alloy wire.

65. The insulin pump of claim 56, wherein the shape memory alloy wire is up to 40 mm long.

66. The insulin pump of claim 56, wherein the shape memory alloy wire is 125 microns in diameter.

67. The insulin pump of claim 56, wherein the plunger pumps 0.1 microliter of insulin per each pump cycle.

68. The insulin pump of claim 67, wherein the insulin pump has an effective maximum of 3000 cycles.

69. The insulin pump of claim 56, wherein the plunger has a shaft sized for slidable movement in a rigid restraint so that the plunger is constrained to a periodic movement relative to the displacement cavity.