Transcutaneous delivery means

• US 20040092865A1
• Filed: 10/08/2003
• Published: 05/13/2004
• Est. Priority Date: 11/09/2001
• Status: Abandoned Application

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Flaherty, J. Christopher, Garibotto, John T.
• Application Number:
  US10/681,731
• Publication Number:
  US 20040092865A1
• Time in Patent Office: Days
• US Class Current: 604/93.01
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• 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 a passageway having a proximal fluid transport tube, a distal fluid transport tube, and a tubular expansion member coupling the fluid transport tubes. A penetrating member is positioned within the expansion member for axial movement between the fluid transport tubes, and has a sharpened distal tip. The device also includes a dispenser for causing fluid from a reservoir to flow to the proximal fluid transport tube, a housing containing the dispenser and the passageway and including an exit port receiving the distal fluid transport tube, and a connecting member secured to the penetrating member. The connecting member is movable by a user from an exterior of the housing and arranged such that movement causes the penetrating member to move between an extended position for subcutaneously inserting the distal fluid transport tube into a patient, and a retracted position.

Claims

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

a housing defining a reservoir;

an inlet valve accessible from an exterior of the housing and connected to the reservoir;

a subcutaneous infusion cannula extending from the housing, in fluid communication with the reservoir and including a distal tip; and

a skin penetrating member movably positioned within the infusion cannula between a retracted position wherein a sharpened tip of the penetrating member is contained within the device and an extended position wherein the sharpened tip of the penetrating member extends from the distal tip of the cannula.

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

a fluid passageway including,

a proximal fluid transport tube;

a distal fluid transport tube;

a tubular expansion member coupling the fluid transport tubes;

a penetrating member positioned within the expansion member for axial movement between the fluid transport tubes, the penetrating member having a sharpened distal tip;

a dispenser for causing fluid from a reservoir to flow to the proximal fluid transport tube;

a housing containing the dispenser and the fluid passageway and including an exit port receiving the distal fluid transport tube; and

a connecting member secured to the penetrating member, movable from an exterior of the housing, and arranged such that movement of the connecting member causes the distal tip of the penetrating member to move one of towards the distal fluid transport tube to an extended position and away from the distal fluid transport tube to a retracted position.

2. A device according to claim 1, wherein the penetrating member is a needle.

3. A device according to claim 1, wherein the penetrating member is hollow.

4. A device according to claim 1, wherein the penetrating member is solid.

5. A device according to claim 1, wherein the penetrating member is flexible.

6. A device according to claim 1, wherein the penetrating member is straight.

7. A device according to claim 1, wherein the penetrating member is curved.

8. A device according to claim 1, wherein the distal tip of the penetrating member is positioned within the housing when the penetrating member is in the retracted position.

9. A device according to claim 1, wherein the penetrating member and the fluid passageway are sized to allow fluid flow between the passageway and the penetrating member.

10. A device according to claim 1, wherein an outside diameter of the penetrating member is substantially equal to an inside diameter of the distal fluid transport tube.

11. A device according to claim 1, wherein at least a portion of an outside diameter of the penetrating member is greater than an inside diameter of the distal fluid transport tube.

12. A device according to claim 1, wherein the proximal fluid transport tube is attached to both the connecting member and the penetrating member.

13. A device according to claim 1, wherein the expansion member is attached to both the connecting member and the penetrating member.

14. A device according to claim 1, further comprising a lubricant on or near the outside surface of the penetrating member.

15. A device according to claim 1, further comprising a therapeutic agent on a surface of the distal fluid transport tube.

16. A device according to claim 15, wherein the therapeutic agent includes at least one of an antibiotic agent, an analgesic agent, and a topical anesthetic.

17. A device according to claim 1, wherein the distal fluid transport tube is flexible.

18. A device according to claim 1, wherein the distal fluid transport tube is rigid.

19. A device according to claim 1, wherein a side wall of the distal fluid transport tube includes at least one opening adjacent a distal tip of the distal fluid transport tube.

20. A device according to claim 19, wherein the distal tip of the distal fluid transport tube is closed.

21. A device according to claim 1, wherein the proximal fluid transport tube is flexible.

22. A device according to claim 1, wherein the proximal fluid transport tube is rigid.

23. A device according to claim 1, wherein the connecting member is attached to the expansion member.

24. A device according to claim 1, wherein an inner diameter of the expansion member is greater than an outer diameter of the penetrating member.

25. A device according to claim 1, wherein an inner diameter of the distal fluid transport tube is greater than an outer diameter of the penetrating member.

26. A device according to claim 1, wherein the expansion member has a bellows-type construction.

27. A device according to claim 1, wherein an inner diameter of the expansion member substantially equals an outer diameter of the penetrating member.

28. A device according to claim 1, wherein the expansion member is connected to the proximal fluid transport tube through the connecting member.

29. A device according to claim 1, wherein the device is attachable to a patient'"'"'s skin, and a direction of movement of the connecting member is substantially parallel to a surface of the skin.

30. A device according to claim 1, wherein the device is attachable to a patient'"'"'s skin, and a direction of movement of the connecting member is substantially perpendicular to a surface of the skin.

31. A device according to claim 1, wherein movement of the connecting member in a first direction causes the penetrating member to move towards a distal end of the distal fluid transport tube and movement of the connecting member in a second direction causes the penetrating member to move away from the distal end of the distal fluid transport tube.

32. A device according to claim 31, wherein the connecting member is biased in the second direction.

33. A device according to claim 31, wherein the connecting member is biased in the first direction.

34. A device according to claim 1, wherein the connecting member extends through the expansion member and is mechanically attached to the penetrating member.

35. A device according to claim 1, wherein the connecting member extends through the proximal fluid transport tube and is mechanically attached to the penetrating member.

36. A device according to claim 1, wherein the connecting member is connected to the penetrating member through one of the proximal fluid transport tube, the expansion member, and distal fluid transport tube.

37. A device according to claim 1, wherein the connecting member includes a control knob extending through the housing, and the housing includes reference markings adjacent the control knob to provided a visual indication of the position of the penetrating member.

38. A device according to claim 1, further comprising a reservoir, and the dispenser controls fluid flow from the reservoir to the proximal fluid transport tube.

39. A device according to claim 38, wherein the reservoir contains a therapeutic fluid.

40. A device according to claim 38, further comprising a fill port connected to the reservoir.

41. A device according to claim 38, wherein the reservoir is pressurized.

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

a local processor connected to the dispenser and programmed to cause the dispenser to allow fluid flow from a reservoir to the proximal fluid transport tube based on 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

wherein the housing is free of user input components for providing flow instructions to the local processor.

43. A system including a fluid delivery device according to claim 42, 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.

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

a local processor connected to the dispenser and programmed to cause the dispenser to allow fluid flow from a reservoir to the proximal fluid transport tube based on flow instructions, and further programmed to provide flow information;

a wireless transmitter connected to the local processor for transmitting the flow information from the local processor to a separate, remote control device; and

wherein the housing is free of user output components for providing the flow information from the local processor to a user.

45. A system including a fluid delivery device according to claim 44 and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user output components connected to the remote processor for allowing a user to receive flow information; and

a receiver connected to the remote processor for receiving the flow information from the transmitter of the fluid delivery device.

46. A device according to claim 1, further comprising an adhesive layer on an outer surface of the housing.

47. A device according to claim 1, wherein the exit port includes an elongated bore receiving and supporting the distal fluid transport tube.

49. A device according to claim 48, further comprising an adhesive layer on an outer surface of the housing adjacent the infusion cannula.

50. A device according to claim 48, wherein the subcutaneous infusion cannula is flexible.

51. A device according to claim 48, wherein the subcutaneous infusion cannula includes at least two lumen.

52. A device according to claim 48, wherein the inlet valve includes a needle septum.

53. A device according to claim 48, wherein the inlet valve includes a Luer connector.

54. A device according to claim 48, wherein the inlet valve includes a one-way valve.

55. A device according to claim 48, wherein an outer dimension of the skin penetrating member is greater than an inner dimension of the subcutaneous infusion cannula.

56. A device according to claim 48, wherein the penetrating member is a needle.

57. A device according to claim 48, wherein the penetrating member is hollow.

58. A device according to claim 48, wherein the penetrating member is solid.

59. A device according to claim 48, wherein the penetrating member is flexible.

60. A device according to claim 48, wherein the penetrating member is straight.

61. A device according to claim 48, wherein the penetrating member is curved.

62. A device according to claim 48, wherein a length of the penetrating member is greater than a lateral dimension of the housing.

63. A device according to claim 48, wherein a length of a path of movement of the penetrating member is greater than a lateral dimension of the housing.

64. A device according to claim 48, wherein the skin penetrating member passes through a port in the housing into the infusion cannula.

65. A device according to claim 48, further comprising a movable retractor extending through the housing and connected to the penetrating member.

66. A device according to claim 65, wherein the retractor is detachably connected to the penetrating member.

67. A device according to claim 65, wherein the retractor extends through the inlet valve.

68. A device according to claim 65, wherein the retractor passes through a port in the housing.

69. A device according to claim 48, further comprising a flow restricting element in the cannula.

70. A device according to claim 69, further comprising an expandable accumulator in fluid communication between the reservoir and the flow restrictor.

71. A device according to claim 70, wherein accumulator comprises a compliant section of the cannula.

72. A device according to claim 70, wherein the accumulator includes a constraint limiting the accumulator to a predetermined maximum volume.

73. A device according to claim 69, wherein the penetrating member passes through the flow restricting element.

74. A device according to claim 73, wherein the flow restricting element resiliently expands to receive the penetrating member.

75. A device according to claim 48, wherein the reservoir comprises first and second portions, and wherein the first portion is connected to the infusion cannula and the second reservoir is expandable and connected to the inlet valve, and wherein the portions are arranged such that expansion of the second portion increases pressure within the first portion.

76. A device according to claim 75, wherein the first and the second portions of the reservoir are separated by a movable plunger.

77. A device according to claim 75, wherein the first and the second portions of the reservoir are formed of flexible membranes.

78. A device according to claim 75, wherein the first portion of the reservoir has a fixed volume.

80. A device according to claim 75, wherein the first portion of the reservoir is prefilled with medication.

81. A device according to claim 75, wherein the first portion of the reservoir includes a fill port.

78-1. A device according to claim 75, wherein a volume of the first portion of the reservoir is restricted by the housing of the device.