Dispenser components and methods for patient infusion device

• US 7,144,384 B2
• Filed: 09/30/2002
• Issued: 12/05/2006
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Flaherty, J. Christopher, Rohatgi, Gaurav, Garibotto, John T., Gorman, William, Bussiere, John R.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/261,003
• Publication Number:
  US 20040064088A1
• Time in Patent Office: 1,527 Days
• Field of Search: 604/150, 604/151, 604/152, 604/154, 604/156, 604/30, 604/131, 604/236, 604/247, 128/DIG.1
• US Class Current: 604/131
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons

Abstract

A device for delivering fluid to a patient including 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 longitudinally extending towards the outlet, and a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir. A tube is coaxially received on the lead screw and includes a longitudinal slot, a pin extending through the lead screw and the slot of the tube, and a gear is secured to the tube for rotation therewith.

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 longitudinally 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;

a tube coaxially received on the lead screw and including a longitudinal slot;

a pin extending through the lead screw and the slot of the tube; and

a gear secured to the tube for rotation therewith.

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

a reference element secured to the pin;

at least one light emitter directed laterally at the tube for directing a beam of light at the tube;

at least one light detector directed laterally at the tube for receiving the beam of light reflected away from the tube;

wherein one of the tube and the reference element has a light reflective outer surface.

3. A device according to claim 2, wherein the reference element has a light reflective outer surface.

4. A device according to claim 2, wherein the reference element is annular and coaxially received for sliding movement along an outer surface of the tube.

5. A device according to claim 1, wherein the lead screw extends through and is threadedly received within a non-rotating nut assembly.

6. A device according to claim 5, wherein the non-rotating nut assembly comprises:

at least two laterally movable threaded inserts including threaded surfaces for threadedly receiving the lead screw upon being biased laterally inwardly against the lead screw;

a spring biasing the threaded inserts laterally inwardly against the lead screw; and

at least one spacer cam movable between a first position preventing the threaded inserts from being biased laterally inwardly against the lead screw and a second position allowing the threaded inserts to be biased laterally inwardly against the lead screw.

7. A device according to claim 6, wherein, in the first position, the spacer cam is positioned between the threaded inserts.

8. A device according to claim 6, wherein the spacer cam is laterally movable with respect to the lead screw.

9. A device according to claim 6, wherein the spacer cam is operatively connected to the gear such that rotation of the gear causes movement of the spacer cam to the second position.

10. A device according to claim 6, further comprising:

a gear cam operatively connected with the gear for rotation with the gear about the lead screw;

a spacer follower laterally moveable with respect to the lead screw and connected to the spacer cam such that lateral movement of the spacer follower in a first direction with respect to the lead screw causes movement of the spacer cam to the second position, wherein the spacer follower is received against the gear cam and the gear cam and the spacer follower are shaped such that rotation of the gear cam about the lead screw causes lateral movement of the spacer follower in the first direction with respect to the lead screw.

11. A device according to claim 10, wherein the spacer follower and the spacer cam are connected through a spacer ring coaxially positioned with respect to the lead screw.

12. A device according to claim 10, wherein the gear cam is provided as part of a gear ring coaxially positioned with respect to the lead screw and including at least one spline extending into a keyway of the gear.

13. A device according to claim 12, wherein the gear cam is formed in a radially outwardly facing surface of the spline.

14. A device according to claim 12, wherein the gear ring includes a latch allowing the spacer follower to exit the gear cam and preventing the spacer follower from re-entering the gear cam.

15. A device according to claim 1, further comprising a set of at least two pawls, wherein each pawl engages teeth of the gear and allows rotation of the gear in a single direction.

16. A device according to claim 1, further comprising a ratchet member movable with respect to the gear and including a ratchet engaging teeth of the gear such that movement of the ratchet in a first direction causes rotation of the gear while movement of the ratchet in a second direction causes no rotation of the gear.

17. A device according to claim 16, further comprising 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, wherein the shape memory element is secured to the ratchet member such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet in one of the first and the second directions.

18. A device according to claim 17, wherein the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet in the first direction.

19. A device according to claim 18, wherein the ratchet is biased in the second direction by a ratchet spring.

20. A device according to claim 19, wherein the ratchet spring comprises a hinge spring.

21. A device according to claim 16, wherein the ratchet is linearly moveable in the first and the second directions.

22. A device according to claim 16, wherein the ratchet member comprises:

an anchor fixed in position with respect to the gear; and

a spring biasing the ratchet in the second direction and away from the anchor.

23. A device according to claim 1, further comprising a sensor detecting linear movement of the lead screw.

24. A device according to claim 23, further comprising:

a non-rotating nut fixed with respect to the reservoir and threadedly receiving the lead screw therethrough so that rotation of the lead screw causes linear movement of the lead screw with respect to the nut;

a ratchet operatively arranged with respect to the gear such that movement of the ratchet in a first direction causes rotation of the gear while movement of the ratchet in a second 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, wherein the shape memory element is secured to the ratchet member such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet in one of the first and the second directions; and

a processor connected to the shape memory element and the sensor detecting linear movement of the lead screw, and programmed to apply a charge to the shape memory element and remove the charge upon receiving a signal from the sensor indicative of linear movement of the lead screw.

25. A device according to claim 1, further comprising a ratchet engaging teeth of the gear such that movement of the ratchet in a first direction causes rotation of the gear while movement of the ratchet in a second direction causes no rotation of the gear, a first electrical lead connected to the gear, and a second electrical lead connected to the ratchet, and wherein the gear and the ratchet are made from electrically conductive material.

26. A device according to claim 25, further comprising a processor connected to the first and second electrical leads and programmed to determine whether the gear has rotated based at least in part on electrical discontinuities between the ratchet and the gear.

27. A device according to claim 25, further comprising at least one pawl allowing rotation of the gear in a single direction and a third electrical lead connected to the pawl, and wherein the pawl is made from electrically conductive material.

28. A device according to claim 27, further comprising a processor connected to the first, the second and the third electrical leads and programmed to determine whether the gear has rotated based at least in part on electrical discontinuities between the ratchet, the pawl and the gear.

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

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, wherein the shape memory element is secured to the ratchet such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet in one of the first and the second directions; and

a processor connected to the shape memory element and the first and second electrical leads, and programmed to,

apply a charge to the shape memory element in order to cause rotation of the gear,

determine whether the gear has been rotated based at least in part on electrical discontinuities between the ratchet and the gear, and

remove the charge from the shape memory element upon determining that the gear has been rotated.

30. A device according to claim 1, further comprising an electrically conductive brush biased against a face of the gear, and wherein the face of the gear includes radially spaced bumps thereon, and wherein one of the face and the bumps are electrically conductive.

31. A device according to claim 30, further comprising a processor connected to the brush and one of the face and the bumps of the gear, and programmed to determine whether the gear has rotated based at least in part on electrical discontinuities between the brush and the gear.

32. A device according to claim 30, wherein the bumps of the gear correspond to outer circumferential teeth of the gear.

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

an encoder disk coaxially secured to the tube and including radially spaced light reflective indicia thereon;

a light emitter directed at the encoder disk; and

a light detector directed at the encoder disk.

34. A device according to claim 33, wherein the radially spaced light reflective indicia is located on an outer circumferential surface of the encoder disk.

35. A device according to claim 33, wherein the encoder disk is secured to the gear.

36. A device according to claim 33, wherein the encoder disk has a recess on a face thereof.

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

a reference element secured to the pin for longitudinal movement along an outer surface of the tube;

at least one light emitter directed laterally at the outer surface of the tube; and

at least one light detector directed laterally at the outer surface of the tube;

wherein one of the outer surface of the tube and the reference element is relatively light reflective; and

wherein the encoder disk includes a recess on a face thereof to receive the reference element.

38. A device according to claim 37, wherein the reference element has a light reflective outer surface.

39. A device according to claim 37, wherein the reference element is annular and coaxially received for sliding movement along an outer surface of the tube.

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

a rotary motor mated to a proximal end of the lead screw for causing rotation of the lead screw relative to the motor; and

a longitudinal guide extending parallel with the lead screw and receiving the motor, wherein the guide allows longitudinal movement of the motor and prevents rotation of the motor.

41. A device according to claim 40, wherein the rotary motor and the longitudinal guide have non-circular cross-sections preventing rotation of the motor with respect to the guide.

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

a reflector secured to the motor;

at least one light emitter fixed with respect to the motor and directed longitudinally at the reflector; and

at least one light detector fixed with respect to the motor and directed longitudinally at the reflector.

43. A device according to claim 42, wherein the reflector is oriented at an angle with respect to the guide of the motor.

44. A device according to claim 42, further comprising a processor connected to the light emitter and the light detector and programmed to determine a longitudinal distance of the reflector from the light emitter based upon a lateral distance between a beam of light directed from the light emitter to the reflector and the beam of light as received by the light detector from the reflector.

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

at least one light emitter directed laterally within the longitudinal guide; and

at least one light detector directed laterally within the longitudinal guide;

wherein one of guide and the motor is relatively light reflective.

46. A device according to claim 45, wherein the motor is relatively reflective.

47. A device according to claim 45, comprising a plurality of the light emitters and light detectors spaced longitudinally within the guide.

48. A device according to claim 1, wherein the lead screw is made from electrically resistive material and extends through and is threadedly received within a non-rotating longitudinally fixed nut made from electrically conductive material.

49. A device according to claim 48, further comprising a processor connected to the nut and the lead screw and programmed to detect an electrical signal between the nut and the lead screw.

50. A device according to claim 49, wherein the processor is further programmed to determine a relative position between the nut and the lead screw based on one of the electrical signal and changes to the electrical signal.

51. A device according to claim 1, further comprising teeth secured to the tube and a pawl engaging the teeth of the tube and allowing rotation of the tube in a single direction.

52. A device according to claim 50, wherein the teeth of the tube are radially arranged on an end wall of the tube.

53. A device according to claim 50, wherein the teeth of the tube are circumferentially arranged on a side wall of the tube.

54. A device according to claim 50, wherein the teeth of the tube are unitarily formed as a single piece with the tube.

55. A device according to claim 43, wherein the teeth of the tube are molded as part of the tube.

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

a ratchet member including,

spaced-apart feet movable in first and second opposing directions with respect to the gear,

a resiliently flexible arch extending between the spaced-apart sliding feet and towards the gear,

a ratchet extending from the arch and engaging teeth of the gear such that movement of the ratchet member in the first direction with respect to the gear causes rotation of the gear while movement of the ratchet member in the second direction with respect to the gear causes no rotation of the gear and causes deflection of the arch away from the gear; and

a switch positioned with respect to the arch of the ratchet member such that the arch contacts the switch upon deflection of the arch away from the gear during movement of the ratchet member in the second direction with respect to the gear.

57. A device according to claim 56, further comprising 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, wherein the shape memory element is secured to the ratchet member such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet in one of the first and the second directions.

58. A device according to claim 56, wherein the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet member in the first direction.

59. A device according to claim 57, wherein the ratchet member is biased in the second direction by a ratchet spring.

60. A device according to claim 56, wherein the ratchet member is linearly moveable in the first and the second directions.

61. A device according to claim 1, further comprising a ratchet member including arms pivotally secured on the tube on opposite sides of the gear and including a ratchet engaging teeth of the gear such that pivotal movement of the ratchet member about the tube in a first direction causes rotation of the gear while pivotal movement of the ratchet member about the tube in a second direction causes no rotation of the gear.

62. A device according to claim 61, wherein the ratchet member comprises:

an anchor fixed in position with respect to the gear; and

a spring biasing the ratchet member in the second direction and towards the anchor.

63. A device according to claim 61, further comprising 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, wherein the shape memory element is secured to the ratchet member such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes pivotal movement of the ratchet in one of the first and the second directions.

64. A device according to claim 63, wherein the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes pivotal movement of the ratchet in the first direction.

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

66. A device according to claim 65, wherein the side wall of the reservoir and the plunger each have a non-circular cross-section.

67. A device according to claim 1, 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 1, 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 longitudinally 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;

a gear radially extending from the lead screw, wherein the gear and the lead screw are operatively connected such that rotation of the gear about the lead screw causes longitudinally movement of the lead screw towards the outlet of the reservoir; and

a ratchet member including arms pivotally secured on the lead screw on opposite sides of the gear and including a ratchet engaging teeth of the gear such that pivotal movement of the ratchet member about the lead screw in a first direction causes rotation of the gear while pivotal movement of the ratchet member about the lead screw in a second direction causes no rotation of the gear.

72. A device according to claim 71, wherein the ratchet member comprises:

an anchor fixed in position with respect to the gear; and

a spring biasing the ratchet in the second direction and towards the anchor.

73. A device according to claim 71, further comprising 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, wherein the shape memoiy element is secured to the ratchet member such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes pivotal movement of the ratchet in one of the first and the second directions.

74. A device according to claim 73, wherein the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes pivotal movement of the ratchet in the first direction.

75. A device according to claim 71, 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 71, 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 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 longitudinally 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;

a gear radially extending from the lead screw, wherein the gear and the lead screw are operatively coniiected such that rotation of the gear about the lead screw causes longitudinally movement of the lead screw towards the outlet of the reservoir; and

a ratchet member including,

spaced-apart feet movable in first and second opposing directions with respect to the gear,

a resiliently flexible arch extending between the spaced-apart feet and towards the gear,

a ratchet extending from the arch and engaging teeth of the gear such that movement of the ratchet member in the first direction causes rotation of the gear while movement of the ratchet member in the second direction with respect to the gear causes no rotation of the gear and causes deflection of the arch away from the gear.

80. A device according to claim 79, further comprising a switch positioned with respect to the arch of the ratchet member such that the arch contacts the switch upon deflection of the arch away from the gear.

81. A device according to claim 79, further comprising 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, wherein the shape memory element is secured to the ratchet member such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet member in one of the first and the second directions.

82. A device according to claim 81, wherein the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet member in the first direction.

83. A device according to claim 79, wherein the ratchet member is biased in the second direction by a ratchet spring.

84. A device according to claim 79, wherein the ratchet member is linearly moveable in the first and the second directions.

85. A device according to claim 79, wherein the reservoir contains a therapeutic fluid.

86. A device according to claim 85, wherein the therapeutic fluid is insulin.

87. A device according to claim 79, wherein the exit port assembly includes a transcutaneous patient access tool.

88. A device according to claim 87, wherein the transcutaneous patient access tool comprises a needle.

89. 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 longitudinally 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;

a gear radially extending from the lead screw, wherein the gear and the lead screw are operatively connected such that rotation of the gear causes longitudinally movement of the lead screw towards the outlet of the reservoir; and

a ratchet member including,

an anchor fixed in position with respect to the gear,

a ratchet engaging teeth of the gear such that movement of the ratchet in a first direction causes rotation of the gear while movement of the ratchet in a second direction causes no rotation of the gear, and

a spring connecting the anchor and the ratchet and biasing the ratchet in one of the first and the second directions.

90. A device according to claim 89, wherein the anchor, the ratchet and the spring of the ratchet member comprise a unitary piece of material.

91. A device according to claim 89, further comprising 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, wherein the shape memory element is secured to the ratchet member such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet member in one of the first and the second directions.

92. A device according to claim 91, wherein the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet member in the first direction.

93. A device according to claim 89, wherein the ratchet is biased in the second direction by the spring.

94. A device according to claim 93, wherein the ratchet is biased in the second direction by a second spring.

95. A device according to claim 94, wherein the second spring comprises a hinge spring.

96. A device according to claim 89, wherein the ratchet is linearly moveable in the first and the second directions.

97. A device according to claim 89, wherein the reservoir contains a therapeutic fluid.

98. A device according to claim 97, wherein the therapeutic fluid is insulin.

99. A device according to claim 89, wherein the exit port assembly includes a transcutaneous patient access tool.

100. A device according to claim 99, wherein the transcutaneous patient access tool comprises a needle.

101. 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 longitudinally 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;

a gear radially extending from the lead screw, wherein the gear and the lead screw are operatively connected such that rotation of the gear causes longitudinally movement of the lead screw towards the outlet of the reservoir, wherein a face of the gear includes radially spaced bumps thereon, and one of the face and the bumps are electrically conductive; and

an electrically conductive brush biased against the face of the gear.

102. A device according to claim 101, further comprising a processor connected to the brush and one of the face and the bumps of the gear, and programmed to determine whether the gear has rotated based at least in part on electrical discontinuities between the brush and the gear.

103. A device according to claim 101, wherein the bumps of the gear correspond to outer circumferential teeth of the gear.

104. A device according to claim 101, 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 101, 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.