Method and apparatus for cerebral embolic protection

• US 6,695,864 B2
• Filed: 07/03/2001
• Issued: 02/24/2004
• Est. Priority Date: 12/15/1997
• Status: Expired due to Term

• Current Assignee: Surgerx Medical, LLC
• Original Assignee: Cardeon Corporation
• Inventors: Leary, James J., Esch, Brady D., Macoviak, John A., Samson, Wilfred J.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/898,302
• Publication Number:
  US 20020010411A1
• Time in Patent Office: 966 Days
• Field of Search: 606/194, 606/200
• US Class Current: 606/200
• 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

An aortic shunt apparatus and methods for cerebral embolic protection are described for isolating the aortic arch vessels from the aortic lumen, for selectively perfusing the arch vessels with a fluid and for redirecting blood flow within the aortic lumen and any potential embolic materials carried in the blood 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 the aorta. The perfusion shunt apparatus has application for protecting a patient from embolic stroke and 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 method of cerebral embolic protection, comprising:

intercepting embolic materials in the blood flow in a patient'"'"'s ascending aorta with an aortic shunt device placed in the patient'"'"'s aortic arch; and

redirecting the embolic materials from the patient'"'"'s ascending aorta past the patient'"'"'s aortic arch vessels to the patient'"'"'s descending aorta.

2. The method of claim 1, further comprising:

perfusing the patient'"'"'s aortic arch vessels with a fluid which is free of embolic materials.

3. The method of claim 2, further comprising:

perfusing the patient'"'"'s aortic arch vessels through a perfusion lumen in the aortic shunt device.

4. The method of claim 3, wherein:

perfusing the patient'"'"'s aortic arch vessels with hypothermic oxygenated blood.

5. The method of claim 1, wherein the aortic shunt device is introduced into the aorta on an elongated catheter shaft.

6. The method of claim 5, further comprising perfusing the patient'"'"'s aortic arch vessels through an arch perfusion lumen in the elongated catheter shaft, the arch perfusion lumen having a fluid connection with an arch perfusion port external to the aortic shunt device.

7. The method of claim 6, further comprising perfusing the patient'"'"'s coronary vessels through a coronary perfusion lumen in the elongated catheter shaft, the coronary perfusion lumen having a fluid connection with a coronary perfusion port upstream of the aortic shunt device.

8. The method of claim 7, further comprising perfusing the patient'"'"'s corporeal vessels through a corporeal perfusion lumen in the elongated catheter shaft, the corporeal perfusion lumen having a fluid connection with a corporeal perfusion port downstream of the aortic shunt device.

9. The method of claim 1, further comprising occluding blood flow through the patient'"'"'s aorta.

10. The method of claim 1, wherein the body of the aortic shunt device has an approximately cylindrical configuration with a central blood flow lumen.

11. The method of claim 10, further comprising occluding the central blood flow lumen.

12. The method of claim 10, further comprising creating a circumferential seal between an upstream end of the aortic shunt device and a wall of the patient'"'"'s ascending aorta.

13. The method of claim 12, further comprising creating a circumferential seal between a downstream end of the aortic shunt device and the wall of the patient'"'"'s descending aorta.

14. The method of claim 1, further comprising creating a seal between an upstream end of the aortic shunt device and a wall of the patient'"'"'s ascending aorta.

15. The method of claim 14, further comprising creating a seal between a downstream end of the aortic shunt device and the wall of the patient'"'"'s descending aorta.

16. A method of cerebral embolic protection, comprising:

intercepting blood flow from a patient'"'"'s ascending aorta with an aortic shunt device placed in the patient'"'"'s aortic arch; and

redirecting the blood flow from the patient'"'"'s ascending aorta and any embolic materials contained in the blood flow past the patient'"'"'s aortic arch vessels to the patient'"'"'s descending aorta.

17. The method of claim 16, further comprising:

perfusing the patient'"'"'s aortic arch vessels with a fluid which is free of embolic materials.

18. The method of claim 17, further comprising:

perfusing the patient'"'"'s aortic arch vessels through a perfusion lumen in the aortic shunt device.

19. The method of claim 18, wherein:

perfusing the patient'"'"'s aortic arch vessels with hypothermic oxygenated blood.

20. The method of claim 16, wherein the aortic shunt device is introduced into the aorta on an elongated catheter shaft.

21. The method of claim 20, further comprising perfusing the patient'"'"'s aortic arch vessels through an arch perfusion lumen in the elongated catheter shaft, the arch perfusion lumen having a fluid connection with an arch perfusion port external to the aortic shunt device.

22. The method of claim 21, further comprising perfusing the patient'"'"'s coronary vessels through a coronary perfusion lumen in the elongated catheter shaft, the coronary perfusion lumen having a fluid connection with a coronary perfusion port upstream of the aortic shunt device.

23. The method of claim 22, further comprising perfusing the patient'"'"'s corporeal vessels through a corporeal perfusion lumen in the elongated catheter shaft, the corporeal perfusion lumen having a fluid connection with a corporeal perfusion port downstream of the aortic shunt device.

24. The method of claim 16, further comprising occluding blood flow through the patient'"'"'s aorta.

25. The method of claim 16, wherein the body of the aortic shunt device has an approximately cylindrical configuration with a central blood flow lumen.

26. The method of claim 25, further comprising occluding the central blood flow lumen.

27. The method of claim 25, further comprising creating a circumferential seal between an upstream end of the aortic shunt device and a wall of the patient'"'"'s ascending aorta.

28. The method of claim 27, further comprising creating a circumferential seal between a downstream end of the aortic shunt device and the wall of the patient'"'"'s descending aorta.

29. The method of claim 16, further comprising creating a seal between an upstream end of the aortic shunt device and a wall of the patient'"'"'s ascending aorta.

30. The method of claim 29, further comprising creating a seal between a downstream end of the aortic shunt device and the wall of the patient'"'"'s descending aorta.

31. Apparatus for cerebral embolic protection, comprising:

an aortic shunt device configured for placement in a patient'"'"'s aortic arch, the aortic shunt device having an upstream end configured for intercepting embolic materials in the blood flow in a patient'"'"'s ascending aorta, a body configured for redirecting the embolic materials past the patient'"'"'s aortic arch vessels, and a downstream end configured for discharging the redirected embolic materials into the patient'"'"'s descending aorta.

32. The apparatus of claim 31, wherein the body of the aortic shunt device is made of a material impermeable to embolic materials.

33. The apparatus of claim 31, wherein the body of the aortic shunt device is made of a material impermeable to blood and embolic materials.

34. The apparatus of claim 31, further comprising an arch perfusion lumen in the elongated catheter shaft, the arch perfusion lumen having a fluid connection with an arch perfusion port external to the body of the aortic shunt device.

35. The apparatus of claim 34, further comprising a coronary perfusion lumen in the elongated catheter shaft, the coronary perfusion lumen having a fluid connection with a coronary perfusion port upstream of the aortic shunt device.

36. The apparatus of claim 35, further comprising a corporeal perfusion lumen in the elongated catheter shaft, the corporeal perfusion lumen having a fluid connection with a corporeal perfusion port downstream of the aortic shunt device.

37. The apparatus of claim 31, further comprising a means for occluding blood flow through the aorta.

38. The apparatus of claim 31, wherein the body of the aortic shunt device has an approximately cylindrical configuration with a central blood flow lumen.

39. The apparatus of claim 38, further comprising a means for occluding the central blood flow lumen.

40. The apparatus of claim 39, wherein the upstream end of the aortic shunt device is configured to create a circumferential seal with a wall of the patient'"'"'s ascending aorta.

41. The apparatus of claim 40, wherein the downstream end of the aortic shunt device is configured to create a circumferential seal with the wall of the patient'"'"'s descending aorta.

42. The apparatus of claim 31, wherein the upstream end of the aortic shunt device is configured to create a seal with the patient'"'"'s ascending aorta.

43. The apparatus of claim 42, wherein the downstream end of the aortic shunt device is configured to create a seal with the patient'"'"'s descending aorta.

44. Apparatus for cerebral embolic protection, comprising:

an aortic shunt device configured for placement in a patient'"'"'s aortic arch, the aortic shunt device having an upstream end configured for intercepting blood flow from the patient'"'"'s ascending aorta, a body configured for redirecting the blood flow from the patient'"'"'s ascending aorta and any potential embolic materials contained in the blood flow past the patient'"'"'s aortic arch vessels, and a downstream end configured for discharging the redirected blood flow into the patient'"'"'s descending aorta.

45. The apparatus of claim 44, wherein the body of the aortic shunt device is made of a material impermeable to embolic materials.

46. The apparatus of claim 44, wherein the body of the aortic shunt device is made of a material impermeable to blood and embolic materials.

47. The apparatus of claim 44, further comprising an arch perfusion lumen in the elongated catheter shaft, the arch perfusion lumen having a fluid connection with an arch perfusion port external to the body of the aortic shunt device.

48. The apparatus of claim 47, further comprising a coronary perfusion lumen in the elongated catheter shaft, the coronary perfusion lumen having a fluid connection with a coronary perfusion port upstream of the aortic shunt device.

49. The apparatus of claim 48, further comprising a corporeal perfusion lumen in the elongated catheter shaft, the corporeal perfusion lumen having a fluid connection with a corporeal perfusion port downstream of the aortic shunt device.

50. The apparatus of claim 44, further comprising a means for occluding blood flow through the aorta.

51. The apparatus of claim 44, wherein the body of the aortic shunt device has an approximately cylindrical configuration with a central blood flow lumen.

52. The apparatus of claim 51, further comprising a means for occluding the central blood flow lumen.

53. The apparatus of claim 51, wherein the upstream end of the aortic shunt device is configured to create a circumferential seal with a wall of the patient'"'"'s ascending aorta.

54. The apparatus of claim 53, wherein the downstream end of the aortic shunt device is configured to create a circumferential seal with the wall of the patient'"'"'s descending aorta.

55. The apparatus of claim 44, wherein the upstream end of the aortic shunt device is configured to create a seal with the patient'"'"'s ascending aorta.

56. The apparatus of claim 55, wherein the downstream end of the aortic shunt device is configured to create a seal with the patient'"'"'s descending aorta.