Perfusion shunt apparatus and method

• US 6,139,517 A
• Filed: 12/14/1998
• Issued: 10/31/2000
• Est. Priority Date: 12/15/1997
• Status: Expired due to Fees

• Current Assignee: Cardeon Corporation
• Original Assignee: Cardeon Corporation
• Inventors: Macoviak, John A., Leary, James J., Esch, Brady D., Samson, Wilfred J.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/212,580
• Time in Patent Office: 687 Days
• Field of Search: 604/28, 604/35, 604/96-104, 604/8, 604/9, 604/53, 606/192-194, 606/200
• US Class Current: 604/8
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 2210/127 Aorta
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A perfusion shunt apparatus and methods are described for isolating and selectively perfusing a segment of a patient'"'"'s cardiovascular system and for directing circulatory flow around the isolated segment. An aortic perfusion shunt apparatus is configured for deployment within a patient'"'"'s aortic arch and methods are described for isolating the aortic arch vessels from the aortic lumen, for selectively perfusing the arch vessels with a fluid and for directing blood flow within the aortic lumen through a shunt past the isolated arch vessels. The perfusion shunt apparatus may be mounted on a catheter or cannula for percutaneous introduction or for direct insertion into a circulatory vessel, such as the aorta. The perfusion shunt apparatus has application for protecting a patient from embolic stroke or hypoperfusion during cardiopulmonary bypass or cardiac surgery and also for selectively perfusing the cerebrovascular circulation with oxygenated blood or with neuroprotective fluids in the presence of risk factors, such as head trauma or cardiac insufficiency. The perfusion shunt apparatus will also find application for selective perfusion of other organ systems within the body.

Claims

1. A perfusion shunt apparatus for use in a body passage, comprising:

a catheter shaft;

an expandable shunt conduit mounted on said catheter shaft, said expandable shunt conduit having an upstream end and a downstream end and an internal lumen, said expandable shunt conduit having a collapsed position in which said expandable shunt conduit is collapsed toward said catheter shaft and an expanded position in which said internal lumen of said expandable shunt conduit is open to fluid flow;

an upstream sealing member at said upstream end of said expandable shunt conduit for creating a seal between said upstream end of said expandable shunt conduit and an internal wall of the body passage;

a perfusion lumen within said catheter shaft in fluid communication with a space exterior to said expandable shunt conduit; and

an occlusion member for selectively occluding said internal lumen of said expandable shunt conduit.

2. The perfusion shunt apparatus of claim 1, wherein said upstream sealing member comprises an inflatable toroidal balloon.

3. The perfusion shunt apparatus of claim 1, wherein said upstream sealing member comprises an elongated expansion member extendible to expand said upstream end of said expandable shunt conduit proximate.

4. The perfusion shunt apparatus of claim 1, wherein said upstream sealing member comprises an external flow control valve.

5. The perfusion shunt apparatus of claim 1, wherein said expandable shunt conduit further comprises at least one longitudinal support member attached to a wall of said expandable shunt conduit.

6. The perfusion shunt apparatus of claim 1, wherein said expandable shunt conduit further comprises a wall of porous fabric enclosing said internal lumen.

7. The perfusion shunt apparatus of claim 6, wherein said expandable shunt conduit further comprises an end wall of porous fabric across said downstream end of said expandable shunt conduit.

8. The perfusion shunt apparatus of claim 1, further comprising an occlusion member for selectively occluding said internal lumen of said expandable shunt conduit.

9. The perfusion shunt apparatus of claim 1, further comprising an infusion lumen within said catheter shaft having an infusion port upstream of said occlusion member.

10. The perfusion shunt apparatus of claim 1, further comprising a downstream sealing member at said downstream end of said expandable shunt conduit for creating a seal between said downstream end of said expandable shunt conduit and the internal wall of the body passage.

11. The perfusion shunt apparatus of claim 10, wherein said upstream sealing member comprises an inflatable toroidal balloon.

12. The perfusion shunt apparatus of claim 11, wherein said downstream sealing member comprises an inflatable toroidal balloon.

13. The perfusion shunt apparatus of claim 10, wherein said upstream sealing member comprises an elongated expansion member extendible to expand said upstream end of said expandable shunt conduit.

14. The perfusion shunt apparatus of claim 13, wherein said downstream sealing member comprises an elongated expansion member extendible to expand said downstream end of said expandable shunt conduit.

15. The perfusion shunt apparatus of claim 10, wherein said upstream sealing member comprises an external flow control valve.

16. The perfusion shunt apparatus of claim 15, wherein said downstream sealing member comprises an external flow control valve.

17. The perfusion shunt apparatus of claim 10, wherein said downstream sealing member comprises a retrograde flow external flow control valve.

18. The perfusion shunt apparatus of claim 17, wherein said upstream sealing member comprises an antegrade flow external flow control valve.

19. The perfusion shunt apparatus of claim 10, further comprising at least one radiopaque marker located on said apparatus.

20. The perfusion shunt apparatus of claim 10, further comprising at least one sonoreflective marker located on said apparatus.

21. The perfusion shunt apparatus of claim 10, further comprising a light emitting device located on said apparatus.

22. The perfusion shunt apparatus of claim 10, wherein said expandable shunt conduit further comprises at least one longitudinal support member attached to a wall of said expandable shunt conduit.

23. The perfusion shunt apparatus of claim 10, wherein said expandable shunt conduit further comprises a wall of impermeable fabric enclosing said internal lumen.

24. The perfusion shunt apparatus of claim 10, wherein said expandable shunt conduit further comprises a wall of porous fabric enclosing said internal lumen.

25. The perfusion shunt apparatus of claim 10, further comprising a second perfusion lumen within said catheter shaft.

26. The perfusion shunt apparatus of claim 10, further comprising a tubular sheath sized to fit over said expandable shunt conduit when in said collapsed position.

27. The perfusion shunt apparatus of claim 10, further comprising an occlusion member for selectively occluding said internal lumen of said expandable shunt conduit.

28. The perfusion shunt apparatus of claim 10, further comprising an infusion lumen within said catheter shaft having an infusion port upstream of said occlusion member.

29. The perfusion shunt apparatus of claim 10, wherein said occlusion number comprises an inflatable occlusion balloon for selectively occluding said internal lumen of said expandable shunt conduit.

30. The perfusion shunt apparatus of claim 10, wherein said catheter shaft is positioned external to said expandable shunt conduit.

31. The perfusion shunt apparatus of claim 10, wherein said catheter shaft is positioned internal to said expandable shunt conduit.

32. The perfusion shunt apparatus of claim 10, further comprising a filter mesh configured to filter fluid flow passing through said internal lumen of said expandable shunt conduit.

33. A method of perfusing a branch vessel in fluid communication with a main vessel in a body of a patient, comprising:

inserting a perfusion shunt catheter into the main vessel;

expanding a shunt conduit mounted on said perfusion shunt catheter to open an internal lumen within said shunt conduit to fluid flow;

sealing an upstream end of said expandable shunt conduit to an internal wall of the main vessel upstream of the branch vessel;

perfusing the branch from a perfusion lumen in fluid communication with a space exterior to said shunt conduit.

perfusing the branch vessel from a perfusion lumen in fluid communication with a space exterior to said shunt conduit.

34. The method of claim 33, further comprising sealing a downstream end of said expandable shunt conduit to an internal wall of the main vessel downstream of the branch vessel.

35. The method of claim 34, wherein said upstream end of said shunt conduit is sealed to the internal wall of the main vessel by inflating a toroidal balloon at said upstream end of said shunt conduit.

36. The method of claim 35, wherein said downstream end of said shunt conduit is sealed to the internal wall of the main vessel by inflating a toroidal balloon at said downstream end of said shunt conduit.

37. The method of claim 34, wherein said upstream end of said shunt conduit is sealed to the internal wall of the main vessel by extending an elongated expansion member to expand said upstream end of said shunt conduit.

38. The method of claim 37, wherein said downstream end of said shunt conduit is sealed to the internal wall of the main vessel by extending an elongated expansion member to expand said downstream end of said shunt conduit.

39. The method of claim 34, wherein said upstream end of said shunt conduit is sealed to the internal wall of the main vessel by an external flow control valve.

40. The method of claim 39, wherein said downstream end of said shunt conduit is sealed to the internal wall of the main vessel by an external flow control valve.

41. The method of claim 34, further comprising imaging said perfiusion shunt catheter with the aid a radiopaque marker located on said perfusion shunt catheter.

42. The method of claim 34, further comprising imaging said perfusion shunt catheter with the aid a sonoreflective marker located on said perfusion shunt catheter.

43. The method of claim 34, further comprising emitting light from a light emitting device located on said perfusion shunt catheter.

44. The method of claim 33, further comprising occluding said internal lumen of said shunt conduit.

45. The method of claim 33 further comprising infusing fluid into the main vessel upstream of said upstream end of said expandable shunt conduit.

46. The method of claim 33, further comprising filtering fluid flow passing through said internal lumen of said shunt conduit.

47. The method of claim 33, where in said perfusion shunt catheter is inserted into the patient'"'"'s aorta;

said upstream end of said expandable shunt conduit is sealed to an internal wall of the aorta upstream of the patient'"'"'s brachiocephalic artery; and

at least one of the patient'"'"'s aortic arch branch vessels is perfused from said perfusion lumen.

48. The method of claim 47 further comprising infusing a cardioplegic agent into the patient'"'"'s aorta upstream of said upstream end of said expandable shunt conduit to induce cardioplegic arrest.

49. The method of claim 34, wherein said perfusion shunt catheter is inserted into the patient'"'"'s aorta;

said upstream end of said expandable shunt conduit is sealed to an internal wall of the aorta upstream of the patient'"'"'s brachiocephalic artery;

said downstream end of said expandable shunt conduit is sealed to an internal wall of the aorta downstream of the patient'"'"'s left subclavian artery; and

at least one of the patient'"'"'s aortic arch branch vessels is perfused from said perfusion lumen.

50. The method of claim 49 further comprising infusing a cardioplegic agent into the patient'"'"'s aorta upstream of said upstream end of said expandable shunt conduit to induce cardioplegic arrest.

51. A perfusion shunt apparatus for us in a body passage, comprising:

a catheter shaft;

an expandable shunt conduit mounted on said catheter shaft, said expandable shunt conduit having a collapsed position in which said expandable shunt conduit is collapsed toward said catheter shaft and an expanded position in which said internal lumen of said expandable shunt conduit is open to fluid flow and wherein said expandable shunt conduit further comprises at least one longitudinal support member attached to a wall of said expandable shunt conduit;

an upstream sealing member at said upstream end of said expandable shunt conduit for creating a seal between said upstream end of said expandable shunt conduit and an internal wall of the body passage; and

a perfusion lumen for within said catheter shaft in fluid communication with a space exterior to said expandable shunt conduit.

52. A perfusion shunt apparatus for use in a body passage, comprising:

a catheter shaft;

an expandable shunt conduit mounted on said catheter shaft, said expandable shunt conduit having an upstream end and a downstream end and in internal lumen, said expandable shunt conduit having a collapsed position in which said expandable shunt conduit is collapsed toward said catheter shaft and an expanded position in which said internal lumen of said expandable shunt conduit is open to fluid flow and wherein said expanded shunt conduit further comprises a wall of porous fabric enclosing said internal lumen;

an upstream sealing member at said upstream end of said expandable shunt conduit for creating a seal between said upstream end of said expandable shunt conduit and an internal wall of the body passage; and

a perfusion lumen for within said catheter shaft in fluid communication with a space exterior to said expandable shunt conduit.

53. The perfusion shunt apparatus of claim 52, wherein said expandable shunt conduit further comprises an end wall of porous fabric across said downstream end of said expandable shunt conduit.

54. A method of perfusing a branch vessel in fluid communication with a main vessel in a body of a patient, comprising:

inserting a perfusion shunt catheter into the main vessel;

expanding a shunt conduit mounted on said perfusion shunt catheter to open an internal lumen within said shunt conduit to fluid flow;

sealing an upstream end of said expandable shunt conduit to an internal wall of the main vessel upstream of the branch vessel;

filtering fluid flow passing through said internal lumen of said shunt conduit; and

perfusing the branch vessel from a perfusion lumen in fluid communication with a space exterior to said shunt conduit.