Intra-pericardial drug delivery device with multiple balloons and method for angiogenesis

• US 6,692,458 B2
• Filed: 12/19/2000
• Issued: 02/17/2004
• Est. Priority Date: 12/19/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bobo, Donald E. Jr., Forman, Michael Robert
• Primary Examiner(s): Freay, Charles G.
• Assistant Examiner(s): Belena, John F
• Application Number:
  US09/741,544
• Publication Number:
  US 20030036726A1
• Time in Patent Office: 1,155 Days
• Field of Search: 604/93.01, 604/96.01, 604/101.02, 604/101.03, 604/101.04, 604/264, 604/523, 604/528, 604/915, 604/917, 604/919, 606/192, 606/194
• US Class Current: 604/93.01
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes an inner shaft longitudinally movable within an outer shaft, each shaft having at least one balloon and at least one lumen formed therein. The catheter prevents leaking through a biological membrane by sealing the catheter tip passageway through the biological membrane with inflatable balloons on either side of the biological membrane. Further, the inflated balloons secure the position of the catheter relative to the biological membrane and the biological space targeted for therapy or diagnosis.

Claims

1. A catheter for delivering agents to a defined biological space in vivo comprising:

an inner catheter shaft defining at least one inner shaft lumen and having an inner shaft distal tip configured to pierce a biological membrane proximate to the biological space;

an outer catheter shaft defining at least one outer shaft lumen and having an outer shaft distal tip;

said inner catheter shaft longitudinally movable within and with respect to said outer catheter shaft; and

at least one deployable support member non-detachably secured to at least one of said inner catheter shaft and said outer catheter shaft.

2. A catheter of claim 1, wherein said at least one deployable support member comprises at least one inflatable balloon in communication with at least one of said lumens of said inner catheter shaft or said outer catheter shaft.

3. A catheter of claim 2, wherein said at least one deployable support member comprises said at least one inflatable balloon disposed on said inner catheter shaft and in communication with said at least one inner shaft lumen.

4. A catheter of claim 2, wherein said at least one deployable support member comprises said at least one inflatable balloon disposed on said outer catheter shaft and in communication with said at least one outer shaft lumen.

5. A catheter of claim 2, wherein said at least one deployable support member comprises said at least one inflatable balloon disposed on said inner catheter shaft and in communication with said at least one inner shaft lumen, and said at least one deployable support member comprises said at least one inflatable balloon disposed on said outer catheter shaft and in communication with said at least one outer shaft lumen.

6. A catheter of claim 1, wherein said at least one deployable support member comprises at least one deployable wire support in communication with at least one of said lumens of said inner shaft or said outer shaft.

7. A catheter of claim 6, wherein said at least one deployable support member comprises said at least one deployable wire support disposed on said inner shaft and in communication with said at least one inner shaft lumen.

8. A catheter of claim 6, wherein said at least one deployable support member comprises said at least one deployable wire support disposed on said outer shaft and in communication with said at least one outer shaft lumen.

9. A catheter of claim 6, wherein said at least one deployable support member comprises said at least one deployable wire support disposed on said inner shaft and in communication with said at least one inner shaft lumen, and said at least one deployable support member comprises said at least one deployable wire support disposed on said outer shaft and in communication with said at least one outer shaft lumen.

10. A catheter of claim 1, wherein said inner shaft distal tip is a needle.

11. The catheter of claim 1, wherein said catheter comprises at least one port positioned proximate to the proximal portion of said catheter and in communication with one of said lumens in said inner catheter shaft, and wherein said lumen is for delivery of an agent to a biological space.

12. A catheter of claim 11, wherein the agent is a therapeutic agent.

13. A catheter of claim 11, wherein the agent is an angiogenic agent.

14. A catheter of claim 11, wherein said at least one port is in communication with at least one of said lumens of said inner catheter shaft and said outer catheter shaft and wherein at least one of said lumens is for the inflation of said inflatable balloon.

15. A catheter of claim 11 wherein said at least one port is in communication with at least one of said lumens of said inner shaft or said outer shaft and wherein at least one of said lumens is for the deployment of said deployable wire support.

16. A catheter of claim 1, wherein said inner shaft distal tip has orifices formed therein for the delivery of an agent from said lumen of said inner catheter shaft to the biological space.

17. A catheter of claim 1 further comprising at least one inflatable sealing balloon in communication with at least one of said lumens of said inner catheter shaft or said outer catheter shaft.

18. A catheter of claim 17, further comprising at least one inflatable balloon positioned on said inner catheter shaft and in communication with said at least one inner shaft lumen.

19. A catheter of claim 17, wherein said catheter disposes said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen.

20. A catheter of claim 17, wherein said catheter disposes said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.

21. A catheter of claim 17, further comprising at least one inflatable balloon positioned on said outer catheter shaft and in communication with said at least one outer shaft lumen.

22. A catheter of claim 17, further comprising at least one inflatable balloon positioned on said inner catheter shaft and in communication with said at least one inner shaft lumen, and at least one inflatable balloon positioned on said outer catheter shaft and in communication with said at least one outer shaft lumen.

23. A catheter of claim 17, wherein said catheter disposes said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, and disposing said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.

24. A catheter of claim 17, further comprising at least one deployable wire support in communication with at least one of said inner catheter shaft and said outer catheter shaft and having said at least one inflatable sealing balloon disposed on at least one of said inner catheter shaft and said outer catheter shaft.

25. A catheter of claim 17, wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen.

26. A catheter of claim 17, wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.

27. A catheter of claim 17, wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.

28. A catheter of claim 17, wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, and disposing said at least one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.

29. A catheter of claim 17, wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, and disposing said at least one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.

30. A catheter for delivering agents to a defined biological space in vivo comprising:

an inner catheter shaft defining at least one inner shaft lumen and having an inner shaft distal tip;

an outer catheter shaft defining at least one outer shaft lumen and having an outer shaft distal tip;

said inner catheter shaft longitudinally movable within and with respect to said outer catheter shaft;

said outer catheter shaft comprising a proximal pusher portion and a distal end portion, said proximal pusher portion configured to be retractable from said distal end portion to uncover said inner catheter shaft; and

at least one deployable support member non-detachably attached to at least one of said inner catheter shaft and said outer catheter shaft.

31. A method for delivering agents to a defined biological space in vivo comprising:

providing a catheter comprising an outer catheter shaft defining at least one outer shaft lumen and having an outer shaft distal tip, and having an inner catheter shaft defining at least one inner shaft lumen and having an inner shaft distal tip, said inner catheter shaft disposed within and movable with respect said outer catheter shaft and disposing at least one deployable support member non-detachable positioned on at least one of said inner catheter shaft and said outer catheter shaft;

guiding said catheter to a surface of the biological space in vivo;

piercing a surface membrane of the biological space with said inner catheter distal tip;

deploying said at least one deployable support member;

infusing an agent into the biological space;

retracting said at least one deployable support member; and

withdrawing said catheter from said biological space.

32. The method of claim 31, wherein said deployable support member comprises at least one inflatable balloon in communication with at least one of said lumens of said inner catheter shaft or said outer catheter shaft.

33. The method of claim 32, wherein said deployable support member comprises at least one inflatable balloon positioned on said inner catheter shaft and in communication with at least one inner shaft lumen.

34. The method of claim 32, wherein said deployable support member comprises at least one inflatable balloon positioned on said outer catheter shaft and in communication with at least one outer shaft lumen.

35. The method of claim 32, wherein said deployable support member comprises at least one inflatable balloon positioned on said inner catheter shaft and in communication with at least one inner shaft lumen and at least one inflatable balloon positioned on said outer catheter shaft and in communication with at least one outer shaft lumen.

36. The method of claim 31, wherein said deployable support member comprises at least one deployable wire support in communication with at least one of said lumens of said inner shaft or said outer shaft.

37. The method of claim 36, wherein said deployable support member comprises at least one deployable wire support disposed on and in communication with at least one inner shaft lumen.

38. The method of claim 36, wherein said deployable support member comprises at least one deployable wire support disposed on and in communication with at least one outer shaft lumen.

39. The method of claim 36, wherein said deployable support member comprises at least one deployable wire support disposed on and in communication with at least one inner shaft lumen, and at least one deployable support member comprises at least one deployable wire support disposed on and in communication with at least one outer shaft lumen.

40. The method of claim 31, wherein the biological space is the pericardial space.

41. The method of claim 31, wherein the biological agent is a therapeutic agent.

42. The method of claim 31, wherein the biological agent is an angiogenic agent.

43. The method of claim 31, further comprising inflating at least one inflatable sealing balloon in communication with at least one of said lumens of said inner catheter shaft or said outer catheter shaft.

44. The method of claim 43, further comprising inflating at least one inflatable balloon positioned on said inner catheter shaft.

45. The method of claim 43, further comprising inflating at least one inflatable balloon positioned on said outer catheter shaft.

46. The method of claim 43, further comprising inflating at least one inflatable balloon positioned on said inner catheter shaft and at least one inflatable balloon positioned on said outer catheter shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.

47. The method of claim 43, further comprising inflating a deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.

48. The method of claim 43, further comprising inflating said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, and disposing said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.

49. The method of claim 43, further comprising inflating said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, and disposing said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.

50. The method of claim 43, further comprising deploying a deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.

51. The method of claim 43, further comprising deploying a deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.

52. The method of claim 43, further comprising deploying a deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.

53. The method of claim 43, further comprising deploying a deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.

54. The method of claim 43, further comprising deploying said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, and disposing said at least one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.

55. The method of claim 43, further comprising:

deploying positioned on said inner catheter shaft; and

inflating at least one inflatable sealing balloon positioned on said outer catheter shaft.

56. The method of claim 31, wherein said catheter further comprises a proximal pusher portion and a distal end portion and said proximal portion is retractable from said distal end portion to uncover said inner catheter shaft.