Dispenser for patient infusion device

• US 6,656,159 B2
• Filed: 04/23/2002
• Issued: 12/02/2003
• Est. Priority Date: 04/23/2002
• Status: Expired due to Term

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Flaherty, J. Christopher
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/128,205
• Publication Number:
  US 20030199825A1
• Time in Patent Office: 588 Days
• Field of Search: 604/131, 604/132, 604/154, 604/151, 604/155, 604/134, 604/135, 604/153, 604/152, 604/133, 604/530, 604/531, 606/78, 606/105
• US Class Current: 604/131
• 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

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 direction causes the plunger to slide along the side wall towards the outlet of the reservoir;

a dispenser including 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 having a first end secured to the lead screw, a portion of the elongated shape memory element wrapped around the lead screw, and a second end fixed with respect to the lead screw, such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes rotation of the lead screw in the first direction.

2. A device according to claim 1, wherein the dispenser further includes a gear secured to the lead screw, and a pawl engaging the gear to prevent rotation of the lead screw in a second direction yet allow rotation of the lead screw in the first direction.

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

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

5. A device according to claim 1, wherein the plunger is non-rotatable with respect to the side wall of the reservoir.

6. A device according to claim 5, wherein the side wall of the reservoir and the plunger have a non-circular cross-section.

7. A device according to claim 5, wherein the side wall of the reservoir includes a channel extending parallel with the lead screw, and the plunger includes a protrusion slidingly received in the channel.

8. A device according to claim 1, wherein:

the reservoir includes an end wall defining the outlet connected to the exit port assembly;

the threaded lead screw extends to the end wall; and

the plunger is non-rotatable with respect to the side wall of the reservoir and is rotatably mounted on the lead screw.

9. A device according to claim 8, wherein the plunger includes an insert threadedly received on the lead screw and wherein the threaded insert and the plunger are made from different materials.

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

a local processor connected to the 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.

11. A system including a fluid delivery device according to claim 10, 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.

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

13. A device according to claim 12, wherein the therapeutic fluid is insulin.

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

15. A device according to claim 14, wherein the transcutaneous patient access tool comprises a needle.

16. A device according to claim 1, wherein the second end of the shape memory element is connected to an auxiliary component of the fluid delivery device for actuating the auxiliary component upon at least a first charge applied to the shape memory element.

17. A device according to claim 16, wherein the auxiliary component comprises a spring-loaded needle of the exit port assembly and the shape memory element is arranged to release the spring-loaded needle for insertion into a patient upon first decreasing from an uncharged length to a charged length when the first charge is applied to the shape memory element.

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

19. A device according to claim 18, further comprising a power supply connected to the local processor.

20. 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 at least partly received 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 rotation of the lead screw in a first direction causes the plunger to slide along the side wall towards the outlet of the reservoir; and

a dispenser including,

a ratchet mechanism secured to the lead screw and including a wheel arranged such that rotation of the wheel in the first direction causes rotation of the lead screw in the first direction, while rotation of the wheel in a second direction causes no rotation of the lead screw,

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 operatively connected to the wheel of the ratchet mechanism such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes rotation of the wheel in one of the first direction and the second direction, and

an actuation element secured to the wheel for moving the wheel in the other of the first direction and the second direction.

21. A device according to claim 20, wherein the actuation element comprises a spring.

22. A device according to claim 21, wherein the spring biases the wheel in the second direction, while the changeable length of the shape memory element decreasing from an uncharged length to a charged length overcomes the biasing force of the spring and causes rotation of the wheel in the first direction.

23. A device according to claim 22, wherein the spring is a helical tension spring that expands upon the shape memory element decreasing from an uncharged length to a charged length, and contracts to increase the shape memory element from a charged length to an uncharged length.

24. A device according to claim 23, wherein the shape memory element extends through a traverse passage in the wheel, the spring biases the wheel such that an uncharged length of the shape memory element is bent, and the shape memory element decreasing from an uncharged length to a charged length straightens the charged length of the shape memory element and rotates the wheel in the first direction against the bias of the spring.

25. A device according to claim 24, further comprising means for limiting rotation of the wheel in the first direction.

26. A device according to claim 24, wherein the wheel includes a radially extending tooth positioned to contact a fixed member and limit rotation of the wheel in the first direction.

27. A device according to claim 24, wherein the ratchet mechanism further includes a gear secured to the lead screw coaxially within the wheel and having teeth extending radially outwardly towards the wheel, and wherein a pawl extends radially inwardly from the wheel and engages the teeth of the gears to prevent relative rotation between the wheel and the gear during rotation of the wheel in the first direction and allow relative rotation between the wheel and the gear during rotation of the wheel in the second direction.

28. A device according to claim 20, wherein the shape memory element comprises a wire.

29. A device according to claim 20, wherein the elongated shape memory element is made of a nickel and titanium alloy.

30. A device according to claim 20, wherein the side wall of the reservoir and the plunger have a non-circular cross-section.

31. A device according to claim 20, wherein the side wall of the reservoir includes a channel extending parallel with the lead screw, and the plunger includes a protrusion slidingly received in the channel.

32. A device according to claim 20, wherein:

the reservoir includes an end wall defining the outlet connected to the exit port assembly;

the threaded lead screw extends to the end wall; and

the plunger is non-rotatable with respect to the side wall of the reservoir and is threadedly received on the lead screw.

33. A device according to claim 32, wherein the plunger includes an insert threadedly received on the lead screw and wherein the threaded insert and the plunger are made from different materials.

34. A device according to claim 20, 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.

35. A system including a fluid delivery device according to claim 34, 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.

36. A device according to claim 20, wherein the reservoir contains a therapeutic fluid.

37. A device according to claim 36, wherein the therapeutic fluid is insulin.

38. A device according to claim 20, wherein the exit port assembly includes a transcutaneous patient access tool.

39. A device according to claim 38, wherein the transcutaneous patient access tool comprises a needle.

40. A device according to claim 20, wherein an end of the shape memory element is connected to an auxiliary component of the fluid delivery device for actuating the auxiliary component upon at least a first charge applied to the shape memory element.

41. A device according to claim 40, wherein the auxiliary component comprises a spring-loaded needle of the exit port assembly and the shape memory element is arranged to release the spring-loaded needle for insertion into a patient upon first decreasing from an uncharged length to a charged length when the first charge is applied to the shape memory element.

42. A device according to claim 20, 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.

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

44. 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 at least partly received 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 rotation of the lead screw in a first direction causes the plunger to slide along the side wall towards the outlet of the reservoir; and

a dispenser including,

a gear secured to the lead screw and including radially extending teeth positioned to contact a first fixed member and prevent rotation of the gear and the lead screw in the second direction,

a slide positioned for linear movement adjacent the gear between a second fixed member and a third fixed member, the slide including a finger for engaging the teeth of the gear, and wherein the finger and the teeth are adapted such that linear movement of the slide past the gear towards the second fixed member causes rotation of the gear in the first direction while linear movement of the slide past the gear towards the third fixed member 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 slide and the third 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 slide past the gear towards the third fixed member, and

an actuation element connected between the slide and the second fixed member for causing linear movement of the slide past the gear towards the second fixed member.

45. A device according to claim 44, wherein the actuation element comprises a spring.

46. A device according to claim 45, wherein the spring is a helical tension spring that expands upon the shape memory element decreasing from an uncharged length to a charged length, and contracts to increase the shape memory element from a charged length to an uncharged length.

47. A device according to claim 44, wherein the actuation element comprises a second 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.

48. A device according to claim 44, wherein the shape memory element comprises a wire.

49. A device according to claim 44, wherein the shape memory element is made of a nickel and titanium alloy.

50. A device according to claim 44, wherein the side wall of the reservoir and the plunger have a non-circular cross-section.

51. A device according to claim 44, wherein the side wall of the reservoir includes a channel extending parallel with the lead screw, and the plunger includes a protrusion slidingly received in the channel.

52. A device according to claim 44, wherein:

the reservoir includes an end wall defining the outlet connected to the exit port assembly;

the threaded lead screw extends to the end wall; and

the plunger is non-rotatable with respect to the side wall of the reservoir and is threadedly received on the lead screw.

53. A device according to claim 52, wherein the plunger includes an insert threadedly received on the lead screw and wherein the threaded insert and the plunger are made from different materials.

54. A device according to claim 44, 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.

55. A system including a fluid delivery device according to claim 54, 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.

56. A device according to claim 44, wherein the reservoir contains a therapeutic fluid.

57. A device according to claim 56, wherein the therapeutic fluid is insulin.

58. A device according to claim 44, wherein the exit port assembly includes a transcutaneous patient access tool.

59. A device according to claim 58, wherein the transcutaneous patient access tool comprises a needle.

60. A device according to claim 44, wherein an end of the shape memory element is connected to an auxiliary component of the fluid delivery device for actuating the auxiliary component upon at least a first charge applied to the shape memory element.

61. A device according to claim 60, wherein the auxiliary component comprises a spring-loaded needle of the exit port assembly and the shape memory element is arranged to release the spring-loaded needle for insertion into a patient upon first decreasing from an uncharged length to a charged length when the first charge is applied to the shape memory element.

62. A device according to claim 44, 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.

63. A device according to claim 62, further comprising a power supply connected to the local processor.

64. 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 direction causes the plunger to slide along the side wall towards the outlet of the reservoir; and

a dispenser including,

a gear secured to the lead screw and including radially extending teeth positioned to contact a first fixed member and prevent rotation of the gear and the lead screw in the second direction,

a slide positioned for linear movement between the gear and a second fixed member, the slide including a finger for engaging the teeth of the gear, wherein the finger and the teeth are adapted such that linear movement of the slide towards the gear causes rotation of the gear in the first direction while linear movement of the slide towards the second fixed member 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 slide and the second 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 slide towards the second fixed member, and

an actuation element connected between the slide and the second fixed member for causing linear movement of the slide towards the gear.

65. A device according to claim 64, wherein the actuation element comprises a spring.

66. A device according to claim 65, wherein the spring is a helical compression spring that contracts upon the shape memory element decreasing from an uncharged length to a charged length, and expands to increase the shape memory element from a charged length to an uncharged length.

67. A device according to claim 64, wherein the shape memory element comprises a wire.

68. A device according to claim 64, wherein the shape memory element is made of a nickel and titanium alloy.

69. A device according to claim 64, wherein the side wall of the reservoir and the plunger have a non-circular cross-section.

70. A device according to claim 64, wherein the side wall of the reservoir includes a channel extending parallel with the lead screw, and the plunger includes a protrusion slidingly received in the channel.

71. A device according to claim 64, wherein:

the reservoir includes an end wall defining the outlet connected to the exit port assembly;

the threaded lead screw extends to the end wall; and

the plunger is non-rotatable with respect to the side wall of the reservoir and is threadedly received on the lead screw.

72. A device according to claim 71, wherein the plunger includes an insert threadedly received on the lead screw and wherein the threaded insert and the plunger are made from different materials.

73. A device according to claim 64, 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.

74. A system including a fluid delivery device according to claim 73, 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.

75. A device according to claim 64, wherein the reservoir contains a therapeutic fluid.

76. A device according to claim 75, wherein the therapeutic fluid is insulin.

77. A device according to claim 64, wherein the exit port assembly includes a transcutaneous patient access tool.

78. A device according to claim 77, wherein the transcutaneous patient access tool comprises a needle.

79. A device according to claim 64, wherein an end of the shape memory element is connected to an auxiliary component of the fluid delivery device for actuating the auxiliary component upon at least a first charge applied to the shape memory element.

80. A device according to claim 79, wherein the auxiliary component comprises a spring-loaded needle of the exit port assembly and the shape memory element is arranged to release the spring-loaded needle for insertion into a patient upon first decreasing from an uncharged length to a charged length when the first charge is applied to the shape memory element.

81. A device according to claim 64, 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.

82. A device according to claim 81, further comprising a power supply connected to the local processor.

83. A device according to claim 64, wherein the dispenser further comprises:

a latch movable between the slide and a third fixed member, the latch for engaging a shoulder of the slide when the latch is moved towards the slide to prevent movement of the slide towards the gear;

a second 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 second shape memory element, the second shape memory element connected between the latch and the third fixed member such that the changeable length of the second shape memory element decreasing from an uncharged length to a charged length causes movement of the latch towards the third fixed member, and

a second actuation element connected between the latch and the third fixed member for causing movement of the latch towards the slide.

84. A device according to claim 83, wherein the latch is linearly movable between the slide and the third fixed member.

85. A device according to claim 83, wherein the second actuation element comprises a second spring.

86. A device according to claim 85, wherein the second spring is a helical compression spring that contracts upon the second shape memory element decreasing from an uncharged length to a charged length, and expands to increase the second shape memory element from a charged length to an uncharged length.

87. A device according to claim 83, wherein the second shape memory element comprises a wire.

88. A device according to claim 83, wherein the second shape memory element is made of a nickel and titanium alloy.

94. A device according to claim 83, wherein the shape memory element is made of a nickel and titanium alloy.

89. An exit port assembly for delivering fluid to a patient comprising:

a fixed member defining a channel having an outlet;

a transcutaneous patient access tool received for sliding movement in the channel towards the outlet;

an actuation element connected between the tool and a second fixed member for causing sliding movement of the tool towards the outlet of the channel;

a movable latch positioned within the channel between the tool and the outlet; and

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 to the latch such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the latch out of the channel.

90. A device according to claim 89, wherein the transcutaneous patient access tool comprises a needle.

91. A device according to claim 89, wherein the actuation element comprises a spring.

92. A device according to claim 91, wherein the spring is a helical compression spring that expands to cause sliding movement of the tool towards the outlet of the channel.

93. A device according to claim 89, wherein the shape memory element comprises a wire.

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

an exit port assembly;

a fill port;

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

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

a plunger having an outer periphery slidably received on the side wall of the reservoir and an inner periphery slidably received on the lead screw and wherein the plunger is non-rotatable with respect to the side wall, the plunger including,

an insert having a threaded surface mateable with the threaded lead screw,

a spring biasing the threaded surface of the insert against the threaded lead screw such that rotating the lead screw in a first direction causes the plunger to slide along the side wall towards the outlet of the reservoir, and

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 having a first end secured to the insert and a second end extending radially outwardly from the insert and secured to the plunger, such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length pulls the threaded surface of the insert away from the threaded lead screw such that the plunger can slide along the lead screw and away from the inlet of the reservoir.

96. A device according to claim 95, wherein the shape memory element comprises a wire.

97. A device according to claim 95, wherein the elongated shape memory element is made of a nickel and titanium alloy.

98. A device according to claim 95, further comprising a dispenser operatively connected to the lead screw for rotating the lead screw to advance the plunger towards the outlet of the reservoir.

99. A device according to claim 98, wherein the dispenser comprises a rotary motor mated to the lead screw.

100. A device according to claim 95, wherein the side wall of the reservoir and the plunger have a non-circular cross-section.

101. A device according to claim 95, wherein the side wall of the reservoir includes a channel extending parallel with the lead screw, and the plunger includes a protrusion slidingly received in the channel.

102. A device according to claim 95, wherein the threaded lead screw is made from a plastic.

103. A device according to claim 95, wherein the plunger includes an outer layer of resiliently flexible material providing a substantially fluid-tight interface between the outer periphery of the plunger and the side wall of the reservoir and the inner periphery of the plunger and the lead screw.

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 according to claim 95, further comprising a power supply connected to the ends of the shape memory element.

109. A device according to claim 95, further comprising a needle pierceable septum contained in the fill port.

110. A device according to claim 95, further comprising a sensor adapted and arranged to provide a signal upon the presence of a needle in the fill port.

111. A device according to claim 110, further comprising a local processor connected to the ends of the shape memory element and connected to the fill port sensor and programmed to provide a charge to the shape memory element upon receiving a signal from the fill port sensor.

112. A device according to claim 111, further comprising a power supply connected to the local processor.

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

an exit port assembly;

a fill port;

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

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

a linearly fixed annular gear coaxially positioned on the threaded lead screw adjacent the reservoir and including,

an insert having a threaded surface mateable with the threaded lead screw,

a spring biasing the threaded surface of the insert against the threaded lead screw such that rotating the gear in a first direction causes the lead screw to move linearly towards the outlet of the reservoir, and

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 having a first end secured to the insert and a second end extending radially outwardly from the insert and secured to the gear, such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length pulls the threaded surface of the insert away from the threaded lead screw such that the lead screw is movable linearly through the gear and away from the inlet of the reservoir; and

a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir.

114. A device according to claim 113, wherein the shape memory element comprises a wire.

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

116. A device according to claim 113, further comprising a dispenser operatively arranged to rotate the gear in the first direction.

117. A device according to claim 116, wherein the dispenser includes at least one shape memory element.

118. A device according to claim 113, wherein the plunger is non-rotatable with respect to the side wall of the reservoir.

119. A device according to claim 118, wherein the side wall of the reservoir and the plunger have a non-circular cross-section.

120. A device according to claim 119, wherein the side wall of the reservoir includes a channel extending parallel with the lead screw, and the plunger includes a protrusion slidingly received in the channel.

121. A device according to claim 113, wherein the reservoir contains a therapeutic fluid.

122. A device according to claim 121, wherein the therapeutic fluid is insulin.

123. A device according to claim 113, wherein the exit port assembly includes a transcutaneous patient access tool.

124. A device according to claim 123, wherein the transcutaneous patient access tool comprises a needle.

125. A device according to claim 113, further comprising a power supply connected to the ends of the shape memory element.

126. A device according to claim 113, further comprising a needle pierceable septum contained in the fill port.

127. A device according to claim 113, further comprising a sensor adapted and arranged to provide a signal upon the presence of a needle in the fill port.

128. A device according to claim 127, further comprising a local processor connected to the ends of the shape memory element and connected to the fill port sensor and programmed to provide a charge to the shape memory element upon receiving a signal from the fill port sensor.

129. A device according to claim 128, further comprising a power supply connected to the local processor.