DISPENSER FOR PATIENT INFUSION DEVICE

• US 20030199824A1
• Filed: 04/23/2002
• Published: 10/23/2003
• Est. Priority Date: 04/23/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: OʼMara, Kerry Dennis, Flaherty, J. Christopher, Garibotto, John T., Gregory, Christopher Carter, Margicin, John Michael, Mahoney, Derek Dwayne
• Granted Patent: US 6,656,158 B2
• Time in Patent Office: Days
• US Class Current: 604/155
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• 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 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14546 Front-loading type injectors

Abstract

A device for delivering fluid, such as insulin for example, to a patient. The device includes an exit port assembly, a syringe-like reservoir including a side wall extending towards an outlet connected to the exit port assembly. A threaded lead screw is received in the reservoir and a plunger has an outer periphery linearly slideable along the side wall of the reservoir and an inner periphery threadedly received on the lead screw. The plunger is non-rotatable with respect to the side wall such that rotating the lead screw causes the plunger to advance within the reservoir and force fluid through the outlet. The device also includes a dispenser having a return element for causes rotation of the lead screw, and a shape memory element. A changeable length of the shape memory element decreasing from an uncharged length to a charged length resets the return element.

Claims

1. A device for delivering fluid to a patient, comprising:

an exit port assembly;

a reservoir including a side wall extending towards an outlet connected to the exit port assembly;

a threaded lead screw received at least partly in the reservoir and extending towards the outlet;

a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir, wherein the plunger and the lead screw are operatively arranged such that rotating the lead screw in a first rotational direction causes the plunger to slide along the side wall towards the outlet of the reservoir;

a dispenser including,

a gear secured to the lead screw and including radially extending teeth,

a moveable pawl positioned for contacting the teeth of the gear during reciprocating linear movement of the moveable pawl adjacent the gear in first and second opposing linear directions, wherein the moveable pawl and the teeth are shaped such that linear movement of the moveable pawl past the gear in the first linear direction causes rotation of the gear in the first rotational direction while linear movement of the moveable pawl past the gear in the second linear direction causes no rotation of the gear,

an elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, the shape memory element connected between the moveable pawl and at least one fixed member such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes linear movement of the moveable pawl past the gear in one of the first and the second linear directions.

2. A device according to claim 1, wherein the shape memory element extends between two fixed members and the moveable pawl is secured to the shape memory element between the two fixed members.

3. A device according to claim 1, wherein the shape memory element comprises two-way shape memory material.

4. A device according to claim 1, wherein the shape memory element comprises one-way shape memory material.

5. A device according to claim 1, wherein the shape memory element comprises a wire.

6. A device according to claim 1, wherein the shape memory element is made of a nickel and titanium alloy.

7. A device according to claim 1, wherein:

the shape memory element extends between opposing first and second ends secured to fixed members;

the moveable pawl is secured to the shape memory element between the first and the second ends and divides the shape memory element into a first portion extending between the first end and the moveable pawl and a second portion extending between the moveable pawl and the second end; and

wherein three separate electrical wires are secured respectively to the first end of the shape memory element, the second end of the shape memory element, and the moveable pawl so that the first and the second portions of the shape memory element can be individually charged.

8. A device according to claim 1, wherein:

the shape memory element extends between opposing first and second ends secured to fixed members;

the moveable pawl is secured to the shape memory element between the first and the second ends; and

the shape memory element includes a first set of at least two elongated parallel portions extending between the first end and the moveable pawl, and a second set of at least two elongated parallel portions extending between the moveable pawl and the second end.

9. A device according to claim 8, wherein three separate electrical wires are secured respectively to the first end of the shape memory element, the second end of the shape memory element, and the moveable pawl so that the first and the second sets of parallel portions can be individually charged.

10. A device according to claim 1, wherein the plunger is threadedly received on the lead screw and prevented from rotating with respect to the side wall of the reservoir.

11. A device according to claim 10, wherein a portion of the side wall of the reservoir and a portion of the plunger have mating non-circular cross-sections.

12. A device according to claim 1, further comprising a fixed pawl preventing rotation of the gear in a second rotational direction opposite the first rotational direction.

13. A device according to claim 1, wherein the moveable pawl and the shape memory element comprise a single, unitary piece.

14. A device according to claim 1, further comprising:

a local processor connected to ends of the shape memory element and programmed to provide charges to the shape memory element based upon flow instructions;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the reservoir, the exit port assembly, the dispenser, the local processor and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor.

15. A system including a fluid delivery device according to claim 14, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

16. A device according to claim 1, wherein the reservoir contains a therapeutic fluid.

17. A device according to claim 16, wherein the therapeutic fluid is insulin.

18. A device according to claim 1, wherein the exit port assembly includes a transcutaneous patient access tool.

19. A device according to claim 18, wherein the transcutaneous patient access tool comprises a needle.

20. A device according to claim 1, further comprising a local processor connected to ends of the shape memory element and programmed to provide charges to the shape memory element based upon flow instructions.

21. A device according to claim 20, further comprising a power supply connected to the local processor.

22. A device according to claim 1, further comprising a fixed pawl assembly preventing rotation of the gear in a second rotational direction opposite the first rotational direction, wherein the fixed pawl assembly includes a pawl and a spring biasing the pawl against the gear.

23. A device according to claim 1, further comprising a fixed pawl assembly preventing rotation of the gear in a second rotational direction opposite the first rotational direction, wherein the fixed pawl assembly includes at least two fixed pawls having different lengths.

24. A device for delivering fluid to a patient, comprising:

an exit port assembly;

a reservoir including a side wall extending towards an outlet connected to the exit port assembly;

a threaded lead screw received at least partly in the reservoir and extending towards the outlet;

a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir, wherein the plunger and the lead screw are operatively arranged such that rotating the lead screw in a first rotational direction causes the plunger to slide along the side wall towards the outlet of the reservoir;

a gear secured to the lead screw and including radially extending teeth;

a moveable pawl assembly including,

a cage coaxially arranged with respect to the lead screw about the gear, the cage linearly movable in opposing first and second linear directions,

a first pawl extending from the cage and biased against the teeth of the gear, wherein the first pawl and the teeth are shaped and oriented such that the first pawl rotates the gear in the first rotational direction during linear movement of the cage in the first linear direction but causes no rotation of the gear during linear movement of the cage in the second linear direction and wherein the first pawl prevents rotation of the gear in an opposite second rotational direction, and

a second pawl extending from the cage and biased against the teeth of the gear, wherein the second pawl and the teeth are shaped and oriented such that the second pawl rotates the gear in the first rotational direction during linear movement of the cage in the second linear direction but causes no rotation of the gear during linear movement of the cage in the first linear direction and wherein the second pawl prevents rotation of the gear in the opposite second rotational direction.

25. A device according to claim 24, further comprising at least one elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, the shape memory element connected between the cage of the moveable pawl assembly and at least one member fixed with respect to the cage, such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes linear movement of the moveable pawl assembly with respect to the gear.

26. A device according to claim 25, wherein:

the shape memory element extends between opposing first and second ends secured to members fixed with respect to the cage;

the cage is secured to the shape memory element between the first and the second ends and divides the shape memory element into a first portion extending between the first end and the cage and a second portion extending between the cage and the second end; and

wherein the first and the second portions of the shape memory element can be individually charged.

27. A device according to claim 25, wherein:

the shape memory element extends between opposing first and second ends secured to fixed members;

the cage is secured to the shape memory element between the first and the second ends;

the shape memory element includes a first set of at least two elongated parallel portions extending between the first end and the cage, and a second set of at least two elongated parallel portions extending between the cage and the second end; and

wherein the first and the second sets of the shape memory element can be individually charged.

28. A device according to claim 25, wherein the shape memory element comprises two-way shape memory material.

29. A device according to claim 25, wherein the shape memory element comprises one-way shape memory material.

30. A device according to claim 25, wherein the shape memory element comprises a wire.

31. A device according to claim 25, wherein the shape memory element is made of a nickel and titanium alloy.

32. A device according to claim 24, wherein the plunger is threadedly received on the lead screw and prevented from rotating with respect to the side wall of the reservoir.

33. A device according to claim 32, wherein a portion of the side wall of the reservoir and a portion of the plunger have mating non-circular cross-sections.

34. A device according to claim 24, wherein the plunger includes a resiliently flexible tip providing a substantially fluid tight seal between the plunger and the side wall of the reservoir.

35. A device according to claim 24, wherein the first and the second pawls are resiliently flexible.

36. A device according to claim 24, wherein the first and the second pawls have arcuate profiles.

37. A device according to claim 24, wherein the first pawl and the second pawl are offset with respect to a tooth pitch of the gear.

38. A device according to claim 24, wherein the first and the second pawls and the cage comprise a single, unitary piece.

39. A device according to claim 25, wherein the cage and the shape memory element comprise a single, unitary piece.

40. A device according to claim 25, further comprising:

a local processor connected to ends of the shape memory element and programmed to provide charges to the shape memory element based upon flow instructions;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the reservoir, the exit port assembly, the dispenser, the local processor and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor.

41. A system including a fluid delivery device according to claim 40, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

42. A device according to claim 40, further comprising a power supply connected to the local processor.

43. A device according to claim 24, wherein the reservoir contains a therapeutic fluid.

44. A device according to claim 43, wherein the therapeutic fluid is insulin.

45. A device according to claim 24, wherein the exit port assembly includes a transcutaneous patient access tool.

46. A device according to claim 45, wherein the transcutaneous patient access tool comprises a needle.

47. A device for delivering fluid to a patient, comprising:

an exit port assembly;

a reservoir including a side wall extending towards an outlet connected to the exit port assembly;

a threaded lead screw received at least partly in the reservoir and extending towards the outlet;

a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir, wherein the plunger and the lead screw are operatively arranged such that rotating the lead screw in a first rotational direction causes the plunger to slide along the side wall towards the outlet of the reservoir;

a first gear secured to the lead screw and including radially extending teeth;

a second gear secured to the lead screw and including radially extending teeth, wherein the second gear is out of phase with the first gear;

a moveable pawl assembly including,

a cage movable in opposing first and second linear directions adjacent the gears,

a first pawl extending from the cage and biased against the teeth of the first gear, wherein the first pawl and the teeth of the first gear are shaped and oriented such that the first pawl rotates the first gear in the first rotational direction during linear movement of the cage in the first linear direction but causes no rotation of the first gear during linear movement of the cage in the second linear direction, and wherein the first pawl prevents rotation of the first gear in an opposite second rotational direction, and

a second pawl extending from the cage and biased against the teeth of the second gear, wherein the second pawl and the teeth of the second gear are shaped and oriented such that the second pawl rotates the second gear in the first rotational direction during linear movement of the cage in the first linear direction but causes no rotation of the second gear during linear movement of the cage in the second linear direction, and wherein the second pawl prevents rotation of the second gear in the opposite second rotational direction.

48. A device according to claim 47, further comprising at least one elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, the shape memory element connected between the cage of the moveable pawl assembly and at least one member fixed with respect to the cage, such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes linear movement of the moveable pawl assembly with respect to the gear.

49. A device according to claim 48, wherein:

the shape memory element extends between opposing first and second ends secured to members fixed with respect to the cage;

the cage is secured to the shape memory element between the first and the second ends and divides the shape memory element into a first portion extending between the first end and the cage and a second portion extending between the cage and the second end; and

wherein the first and the second portions of the shape memory element can be individually charged.

50. A device according to claim 48, wherein:

the shape memory element extends between opposing first and second ends secured to fixed members;

the cage is secured to the shape memory element between the first and the second ends;

the shape memory element includes a first set of at least two elongated parallel portions extending between the first end and the cage, and a second set of at least two elongated parallel portions extending between the cage and the second end; and

wherein the first and the second sets of the shape memory element can be individually charged.

51. A device according to claim 48, wherein the shape memory element comprises two-way shape memory material.

52. A device according to claim 48, wherein the shape memory element comprises one-way shape memory material.

53. A device according to claim 48, wherein the shape memory element comprises a wire.

54. A device according to claim 48, wherein the shape memory element is made of a nickel and titanium alloy.

55. A device according to claim 47, wherein the plunger is threadedly received on the lead screw and prevented from rotating with respect to the side wall of the reservoir.

56. A device according to claim 55, wherein a portion of the side wall of the reservoir and a portion of the plunger have mating non-circular cross-sections.

57. A device according to claim 47, wherein the plunger includes a resiliently flexible tip providing a substantially fluid tight seal between the plunger and the side wall of the reservoir.

58. A device according to claim 47, wherein the first and the second pawls are resiliently flexible.

59. A device according to claim 47, wherein the first and the second pawls have arcuate profiles.

60. A device according to claim 47, wherein the first pawl and the second pawl have a similar length.

61. A device according to claim 47, wherein the first and the second gears are identical and are out of phase by a single tooth pitch.

62. A device according to claim 47, wherein the first and the second pawls and the cage comprise a single, unitary piece.

63. A device according to claim 48, wherein the cage and the shape memory element comprise a single, unitary piece.

64. A device according to claim 48, further comprising:

a local processor connected to ends of the shape memory element and programmed to provide charges to the shape memory element based upon flow instructions;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the reservoir, the exit port assembly, the dispenser, the local processor and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor.

65. A system including a fluid delivery device according to claim 64, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

66. A device according to claim 64, further comprising a power supply connected to the local processor.

67. A device according to claim 47, wherein the reservoir contains a therapeutic fluid.

68. A device according to claim 67, wherein the therapeutic fluid is insulin.

69. A device according to claim 47, wherein the exit port assembly includes a transcutaneous patient access tool.

70. A device according to claim 69, wherein the transcutaneous patient access tool comprises a needle.

71. A device for delivering fluid to a patient, comprising:

an exit port assembly;

a reservoir including a side wall extending towards an outlet connected to the exit port assembly;

a threaded lead screw received at least partly in the reservoir and extending towards the outlet;

a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir, wherein the plunger and the lead screw are operatively arranged such that rotating the lead screw in a first rotational direction causes the plunger to slide along the side wall towards the outlet of the reservoir;

a gear coaxially secured to the lead screw for rotation therewith and including radially extending teeth;

a moveable pawl assembly including,

a cam pivotally mounted coaxially on the lead screw adjacent the gear for pivotal movement in opposing first and second pivotal directions about the lead screw;

a first pawl secured to the cam and extending towards the teeth of the gear, wherein the first pawl and the teeth of the gear are shaped and oriented such that the first pawl rotates the gear in the first rotational direction during pivotal movement of the cam in the first pivotal direction, but causes no rotation of the gear during pivotal movement of the cam in the second pivotal direction, and

a second pawl secured to the cam and extending towards the teeth of the gear, wherein the second pawl and the teeth of the gear are shaped and oriented such that the second pawl rotates the gear in the first rotational direction during pivotal movement of the cam in the first pivotal direction, but causes no rotation of the gear during pivotal movement of the cam in the second pivotal direction, and wherein the first and second pawls have different lengths.

72. A device according to claim 71, further comprising at least one elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, the shape memory element connected between the cam of the moveable pawl assembly and at least one member fixed with respect to the cam, such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes pivotal movement of the cam.

73. A device according to claim 72, wherein:

the shape memory element extends between opposing first and second ends secured to members fixed with respect to the cam;

the cam is secured to the shape memory element between the first and the second ends and divides the shape memory element into a first portion extending between the first end and the cam and a second portion extending between the cam and the second end; and

wherein the first and the second portions of the shape memory element can be individually charged.

74. A device according to claim 72, wherein:

the shape memory element extends between opposing first and second ends secured to fixed members;

the cam is secured to the shape memory element between the first and the second ends;

the shape memory element includes a first set of at least two elongated parallel portions extending between the first end and the cam, and a second set of at least two elongated parallel portions extending between the cam and the second end; and

wherein the first and the second sets of the shape memory element can be individually charged.

75. A device according to claim 72, wherein the shape memory element comprises two-way shape memory material.

76. A device according to claim 72, wherein the shape memory element comprises one-way shape memory material.

77. A device according to claim 72, wherein the shape memory element comprises a wire.

78. A device according to claim 72, wherein the shape memory element is made of a nickel and titanium alloy.

79. A device according to claim 71, wherein the plunger is threadedly received on the lead screw and prevented from rotating with respect to the side wall of the reservoir.

80. A device according to claim 79, wherein a portion of the side wall of the reservoir and a portion of the plunger have mating non-circular cross-sections.

81. A device according to claim 71, wherein the plunger includes a resiliently flexible tip providing a substantially fluid tight seal between the plunger and the side wall of the reservoir.

82. A device according to claim 71, wherein the first and the second pawls are resiliently flexible.

83. A device according to claim 71, wherein the first and the second pawls have arcuate profiles.

84. A device according to claim 71, wherein a difference in the lengths of the first and the second pawls are less than a single tooth pitch of the gear.

85. A device according to claim 72, further comprising:

a local processor connected to ends of the shape memory element and programmed to provide charges to the shape memory element based upon flow instructions;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the reservoir, the exit port assembly, the dispenser, the local processor and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor.

86. A system including a fluid delivery device according to claim 85, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

87. A device according to claim 85, further comprising a power supply connected to the local processor.

88. A device according to claim 71, wherein the reservoir contains a therapeutic fluid.

89. A device according to claim 88, wherein the therapeutic fluid is insulin.

90. A device according to claim 71, wherein the exit port assembly includes a transcutaneous patient access tool.

91. A device according to claim 90, wherein the transcutaneous patient access tool comprises a needle.

92. A device according to claim 71, further comprising a fixed pawl assembly preventing rotation of the gear in a second rotational direction opposite the first rotational direction.

93. A device according to claim 92, wherein the fixed pawl assembly includes at least two fixed pawls having different lengths.

94. A device according to claim 93, wherein a difference in the lengths of the pawls of the fixed pawl assembly are less than a single tooth pitch of the gear.

95. A device for delivering fluid to a patient, comprising:

an exit port assembly;

a reservoir including a side wall extending towards an outlet connected to the exit port assembly;

a threaded lead screw received at least partly within the reservoir and extending towards the outlet;

a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir, wherein the plunger and the lead screw are operatively arranged such that rotation of the lead screw in a first rotational direction causes the plunger to slide along the side wall towards the outlet of the reservoir; and

a dispenser including,

a barrel cam coaxial secured to the lead screw for rotation therewith and including a continuous circumferential groove with helical segments having orientations extending in the first rotational direction and successively alternating between opposing first and second ends of the barrel cam, and

a slide linearly movable in opposing first and second linear directions parallel with the lead screw and adjacent the gear, the slide including a finger extending from the slide and into the circumferential groove of the barrel cam, whereby, when the finger extends into one of the helical segments, linear movement of the slide causes rotation of the barrel cam and the lead screw in the first rotational direction.

96. A device according to claim 95, wherein the groove of the barrel cam also includes axial segments extending from each of junctures between the successive helical segments and extending axially towards the ends of the barrel cam, whereby, when the finger extends into one of the axial segments, linear movement of the slide causes no rotation of the barrel cam and the lead screw.

97. A device according to claim 95, further comprising at least one elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, the shape memory element connected between the slide and a member fixed with respect to the slide such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes linear movement of the slide with respect to the barrel cam.

98. A device according to claim 97, wherein the shape memory element comprises a wire.

99. A device according to claim 97, wherein the shape memory element is made of a nickel and titanium alloy.

100. A device according to claim 97, wherein the shape memory element is made of a two-way shape memory material.

101. A device according to claim 97, further comprising:

a local processor connected to ends of the shape memory element and programmed to provide charges to the shape memory element based upon flow instructions;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the reservoir, the exit port assembly, the dispenser, the local processor and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor.

102. A device according to claim 101, further comprising a power supply connected to the local processor.

103. A system including a fluid delivery device according to claim 101, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

104. A device according to claim 95, wherein the reservoir contains a therapeutic fluid.

105. A device according to claim 104, wherein the therapeutic fluid is insulin.

106. A device according to claim 95, wherein the exit port assembly includes a transcutaneous patient access tool.

107. A device according to claim 106, wherein the transcutaneous patient access tool comprises a needle.

108. A device for delivering fluid to a patient, comprising:

an exit port assembly;

a reservoir including a side wall extending towards an outlet connected to the exit port assembly;

a threaded lead screw received at least partly in the reservoir and extending towards the outlet;

a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir, wherein the plunger and the lead screw are operatively arranged such that rotating the lead screw in a first rotational direction causes the plunger to slide along the side wall towards the outlet of the reservoir;

a dispenser including,

a crankshaft operatively connected to the lead screw such that rotation of the crankshaft in a first rotational direction of the crankshaft causes rotation of the lead screw in the first rotational direction of the lead screw, the crankshaft including a main shaft rotatable about a longitudinal axis, at least one counter weight secured to the main shaft for rotation therewith, and at least one crank pin, the crank pin secured to the main shaft through the counter weight and having a longitudinal axis parallel to but radially offset from the longitudinal axis of the main shaft, and

at least one elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, the shape memory element connected between the crank pin and at least one member fixed with respect to the crankshaft such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes rotation of the crankshaft.

109. A device according to claim 108, wherein the shape memory element extends between two members fixed with respect to the crankshaft and the crank pin is secured to the shape memory element between the two fixed members.

110. A device according to claim 108, wherein the shape memory element comprises two-way shape memory material.

111. A device according to claim 108, wherein the shape memory element comprises one-way shape memory material.

112. A device according to claim 108, wherein the shape memory element comprises a wire.

113. A device according to claim 108, wherein the shape memory element is made of a nickel and titanium alloy.

114. A device according to claim 108, wherein a catch is mounted for rotation on the crank pin with respect to the axis of the crank pin and the shape memory element is secured to the crank pin through the catch, extends between two members fixed with respect to the crankshaft, and the catch divides the shape memory element into a first portion extending between a first end of the shape memory element and the catch and a second portion extending between the catch and a second end of the shape memory element.

115. A device according to claim 114, wherein three separate electrical wires are secured respectively to the first end of the shape memory element, the second end of the shape memory element, and the catch so that the first and the second portions of the shape memory element can be individually charged.

116. A device according to claim 115, further comprising a local processor connected to the three wires of the shape memory element and programmed to alternatively and successively provided charges to the first and the second portions based upon flow instructions.

117. A device according to claim 108, wherein:

the shape memory element extends between opposing first and second ends secured to fixed members;

a catch is mounted for rotation on the crank pin with respect to the axis of the crank pin and the shape memory element is secured to the crank pin through the catch, and the catch divides the shape memory element into a first portion extending between the first end of the shape memory element and the catch and a second portion extending between the catch and the second end of the shape memory element; and

the shape memory element includes a first set of at least two elongated parallel portions extending between the first end and the catch, and a second set of at least two elongated parallel portions extending between the catch and the second end.

118. A device according to claim 117, wherein three separate electrical wires are secured respectively to the first end of the shape memory element, the second end of the shape memory element, and the catch so that the first and the second sets of parallel portions can be individually charged.

119. A device according to claim 118, further comprising a local processor connected to the three wires of the shape memory element and programmed to alternatively and successively provided charges to the first and the second sets of parallel portions based upon flow instructions.

120. A device according to claim 108, wherein the plunger is threadedly received on the lead screw and prevented from rotating with respect to the side wall of the reservoir.

121. A device according to claim 120, wherein a portion of the side wall of the reservoir and a portion of the plunger have mating non-circular cross-sections.

122. A device according to claim 108, wherein the plunger includes a resiliently flexible tip providing a substantially fluid tight seal between the plunger and the side wall of the reservoir.

123. A device according to claim 108, further comprising:

a local processor connected to ends of the shape memory element and programmed to provide charges to the shape memory element based upon flow instructions;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the reservoir, the exit port assembly, the dispenser, the local processor and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor.

124. A system including a fluid delivery device according to claim 123, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

125. A device according to claim 108, wherein the reservoir contains a therapeutic fluid.

126. A device according to claim 125, wherein the therapeutic fluid is insulin.

127. A device according to claim 108, wherein the exit port assembly includes a transcutaneous patient access tool.

128. A device according to claim 127, wherein the transcutaneous patient access tool comprises a needle.

129. A device according to claim 108, further comprising a local processor connected to ends of the shape memory element and programmed to provide charges to the shape memory element based upon flow instructions.

130. A device according to claim 129, further comprising a power supply connected to the local processor.

131. A device according to claim 108, wherein the crankshaft is operatively connected to the lead screw through a pair of cross-helical gears.

132. A device according to claim 108, wherein:

the crank pin of the crankshaft comprises first and second crank pins secured to the main shaft through three counter weights, and wherein the longitudinal axis of each crank pin is parallel to but radially offset from the longitudinal axis of the main shaft and parallel to but radially offset from the longitudinal axis of the other crank pin; and

the shape memory element of the dispenser comprises a first shape memory element secured between the first crank pin and a member fixed with respect to the crankshaft, and a second shape memory element secured between the second crank pin and a member fixed with respect to the crankshaft.

133. A device according to claim 132, wherein a catch is mounted for rotation on each of the crank pins and the shape memory elements are each secured to the crank pins through the catches, extend between two members fixed with respect to the crankshaft, and the catches divide the shape memory elements each into a first portion extending between a first end of the shape memory element and the catch and a second portion extending between the catch and a second end of the shape memory element.

134. A device according to claim 133, wherein each shape memory element includes three separate electrical wires secured respectively to the first end of the shape memory element, the second end of the shape memory element, and the catch so that the first and the second portions of the shape memory element can be individually charged.

135. A device according to claim 134, further comprising a local processor connected to the wires of the shape memory elements and programmed to alternatively and successively provided charges to the portions of the shape memory elements based upon flow instructions.