Transcutaneous delivery means

• US 6,699,218 B2
• Filed: 11/09/2001
• Issued: 03/02/2004
• Est. Priority Date: 11/09/2000
• Status: Expired due to Term

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Garibotto, John T., Flaherty, J. Christopher
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): GhaFoorian, Roz
• Application Number:
  US10/037,902
• Publication Number:
  US 20020123740A1
• Time in Patent Office: 844 Days
• Field of Search: 604/65-68, 604/141, 604/326, 604/180, 604/132, 604/153, 604/142, 604/20-22, 604/67
• 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 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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

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 towards the distal fluid transport tube to an extended position or 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 the proximal fluid transport tube is flexible.

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

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

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

23. 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.

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

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

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

27. 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.

28. 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.

29. A device according to claim 28, wherein the connecting member is biased in the second direction.

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

31. 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.

32. 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.

33. 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.

34. A device according to claim 33, wherein the reservoir contains a therapeutic fluid.

35. A device according to claim 33, wherein the reservoir is pressurized.

36. 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.

37. A system including a fluid delivery device according to claim 36, 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.

38. 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.

39. A system including a fluid delivery device according to claim 38 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.

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

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