Circulatory support system and method of use for isolated segmental perfusion

• US 6,508,777 B1
• Filed: 05/06/1999
• Issued: 01/21/2003
• Est. Priority Date: 05/08/1998
• Status: Expired due to Fees

• Current Assignee: Cardeon Corporation
• Original Assignee: Cardeon Corporation
• Inventors: Baker, Steve, Leary, James J., Macoviak, John, Samson, Wilfred J.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US09/306,555
• Time in Patent Office: 1,356 Days
• Field of Search: 604/4.01, 604/8, 604/9, 604/10, 604/101.01, 604/101-3-1, 604/6.11, 604/6.14, 604/6.16, 604/19, 604/28, 604/506-510, 604/96.01, 422/44
• US Class Current: 604/4.01
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A circulatory support system and method for circulatory support are described for performing cardiopulmonary bypass using differential perfusion and/or isolated segmental perfusion of the circulatory system. The circulatory support system includes one or more venous cannulae for draining blood from the venous side of the patient'"'"'s circulatory system, one or more arterial cannulae for perfusing the arterial side of the patient'"'"'s circulatory system, and one or more blood circulation pumps connected between the venous cannulae and the arterial cannulae. The arterial cannulae and the venous cannulae of the circulatory support system may take one of several possible configurations. The circulatory support system is configured to segment a patient'"'"'s circulatory system into one or more isolated circulatory loops. The circulatory loops may be isolated from one another and/or from the remainder of the patient'"'"'s circulatory system on the venous side, as well as on the arterial side, for isolated closed loop circulatory support of separate organ systems. The circulatory support system is suitable for use in minimally-invasive cardiac surgery, using thoracoscopic, port-access or minithoracotomy techniques, or for standard open-chest cardiac surgery.

Claims

1. A circulator support system comprising:

an arterial cannulation subsystem including a first arterial perfusion lumen adapted to be inserted in a first arterial location and a second arterial perfusion lumen adapted to be inserted in a second arterial location;

a venous cannulation subsystem including a first venous drainage lumen adapted to be inserted in a first venous location and a second venous drainage lumen adapted to be inserted in a second venous location;

a first circulation pump connected the first arterial prefusion lumen of the arterial cannulation subsystem and the first venous drainage lumen of the venous cannulation subsystem; and

a second circulation pump connected between the second arterial perfusion lumen of the arterial cannulation subsystem and the second venous drainage lumen of the venous cannulation subsystem.

2. The circulatory support system of claim 1, wherein:

the arterial cannulation subsystem comprises an arterial cannula having an elongated tubular body with the first arterial perfusion lumen and the second arterial perfusion lumen extending therethrough; and

the venous cannulation subsystem comprises a venous cannula having an elongated tubular body with the first venous drainage lumen and the second venous drainage lumen extending therethrough.

3. The circulatory support system of claim 1, wherein the arterial cannulation subsystem comprises an arterial cannula having an elongated tubular body with the first arterial perfusion lumen and the second arterial perfusion lumen extending therethrough, wherein the first arterial perfusion lumen connects to a first perfusion port and the second arterial perfusion lumen connects to a second perfusion port, and wherein the first perfusion port and the second perfusion port are spaced apart longitudinally along the elongated tubular body of the arterial cannula.

4. The circulatory support system of claim 3, wherein the arterial cannula further comprises a first arterial occlusion member mounted on an exterior of the elongated tubular body between the first perfusion port and the second perfusion port.

5. The circulatory support system of claim 4, wherein the arterial cannula further comprises a second arterial occlusion member mounted on an exterior of the elongated tubular body distal to the first perfusion port and the second perfusion port.

6. The circulatory support system of claim 1, wherein the venous cannulation subsystem comprises a venous cannula having an elongated tubular body with the first venous drainage lumen and the second venous drainage lumen extending therethrough, wherein the first venous drainage lumen connects to a first drainage port and the second venous drainage lumen connects to a second drainage port, and wherein the first drainage port and the second drainage port are spaced apart longitudinally along the elongated tubular body of the venous cannula.

7. The circulatory support system of claim 6, wherein the venous cannula further comprises a first venous occlusion member mounted on an exterior of the elongated tubular body between the first drainage port and the second drainage port.

8. The circulatory support system of claim 7, wherein the venous cannula further comprises a second venous occlusion member mounted on an exterior of the elongated tubular body distal to the first drainage port and the second drainage port.

9. The circulatory support system of claim 1, wherein the arterial cannulation subsystem comprises at least one arterial cannula having at least one occlusion balloon mounted on an exterior thereof.

10. The circulatory support system of claim 1, wherein the arterial cannulation subsystem comprises at least one arterial cannula having at,least one external catheter valve mounted on an exterior thereof.

11. The circulatory support system of claim 1, wherein the venous cannulation subsystem comprises at least one venous cannula having at least one occlusion balloon mounted on an exterior thereof.

12. The circulatory support system of claim 1, wherein the venous cannulation subsystem comprises at least one venous cannula having at least one external catheter valve mounted on an exterior thereof.

13. The circulatory support system of claim 1, further comprising a first heat exchanger connected in series with the first circulation pump.

14. The circulatory support system of claim 13, further comprising a second heat exchanger connected in series with the second circulation pump.

15. The circulatory support system of claim 1, further comprising a first blood oxygenator connected in series with the first circulation pump.

16. The circulatory support system of claim 15, further comprising a second blood oxygenator connected in series with the second circulation pump.

17. The circulatory support system of claim 1, wherein the venous cannulation subsystem further comprises a first venous sensor for sensing a condition of a first portion of a patient'"'"'s blood drained by the first venous drainage lumen and a second venous sensor for sensing a condition of a second portion of the patient'"'"'s blood drained by the second venous drainage lumen.

18. The circulatory support system of claim 1, wherein the arterial cannulation subsystem further comprises a first arterial sensor for sensing condition of a first portion of a patient'"'"'s blood perfused through the first arterial perfusion lumen and a second arterial sensor for sensing a condition of a second portion of the patient'"'"'s blood perfused through the second arterial perfusion lumen.

19. The circulatory support system of claim 1, wherein:

the arterial cannulation subsystem is configured so that, when deployed in a patient'"'"'s circulatory system, the first arterial perfusion lumen communicates with the patient'"'"'s aortic arch and arch vessels and the second arterial perfusion lumen communicates with the patient'"'"'s descending aorta and branch vessels; and

the venous cannulation subsystem is configured so that, when deployed in the patient'"'"'s circulatory system, the first venous drainage lumen communicates with the patient'"'"'s superior vena cava and the second venous drainage lumen communicates with the patient'"'"'s inferior vena cava.

20. The circulatory support system of claim 19, wherein:

the arterial cannulation subsystem further comprises a third arterial perfusion lumen that communicates with the patient'"'"'s coronary arteries.

21. The circulatory support system of claim 19, wherein:

the venous cannulation subsystem further comprises a third venous lumen that communicates with the patient'"'"'s coronary sinus.

22. A method of circulatory support of a patient comprising simultaneously:

draining a first portion of the patient'"'"'s blood from a first venous location in a first segment of the patient'"'"'s circulatory system;

draining a second portion of the patient'"'"'s blood from a second venous location in a second segment of the patient'"'"'s circulatory system;

returning the first portion of the patient'"'"'s blood to a first arterial location within the first segment of the patient'"'"'s circulatory system; and

returning the second portion of the patient'"'"'s blood to a second arterial location within the second segment of the patient'"'"'s circulatory system.

23. The method of claim 22, further comprising:

conditioning the first portion of the patient'"'"'s blood before returning the first portion to the first segment of the patient'"'"'s circulatory system.

24. The method of claim 23, further comprising:

conditioning the second portion of the patient'"'"'s blood before returning the second portion to the second segment of the patient'"'"'s circulatory system.

25. The method of claim 22, further comprising:

cooling the first portion of the patient'"'"'s blood before returning the first portion to the first segment of the patient'"'"'s circulatory system.

26. The method of claim 25, further comprising:

cooling the second portion of the patient'"'"'s blood before returning the second portion to the second segment of the patient'"'"'is circulatory system.

27. The method of claim 22, further comprising:

oxygenating the first portion of the patient'"'"'s blood before returning the first portion to the first segment of the patient'"'"'s circulatory system.

28. The method of claim 27, further comprising:

oxygenating the second portion of the patient'"'"'s blood before returning the second portion to the second segment of the patient'"'"'s circulatory system.

29. The method of claim 22, further comprising:

adding protective or therapeutic agents to the first portion of the patient'"'"'s blood before returning the first portion to the first segment of the patient'"'"'s circulatory system.

30. The method of claim 29, further comprising:

adding protective or therapeutic agents to the second portion of the patient'"'"'s blood before returning the second portion to the second segment of the patient'"'"'s circulatory system.

31. The method of claim 22, further comprising:

isolating the first segment of the patient'"'"'s circulatory system from the second segment of the patient'"'"'s circulatory system on the arterial side of the patient'"'"'s circulatory system.

32. The method of claim 31, further comprising:

isolating the first segment of the patient'"'"'s circulatory system from the second segment of the patient'"'"'s circulatory system on the venous side of the patient'"'"'s circulatory system.

33. The method of claim 22, further comprising inflating an occlusion balloon on the arterial side of the patient'"'"'s circulatory system to isolate the first segment of the patient'"'"'s circulatory system from the second segment of the patient'"'"'s circulatory system.

34. The method of claim 22, further comprising expanding an external catheter valve on the arterial side of the patient'"'"'s circulatory system to isolate the first segment of the patient'"'"'s circulatory system from the second segment of the patient'"'"'s circulatory system.

35. The method of claim 22, further comprising:

isolating the first segment of the patient'"'"'s circulatory system from the second segment of the patient'"'"'s circulatory system on the venous side of the patient'"'"'s circulatory system.

36. The method of claim 22, further comprising inflating an occlusion balloon on the venous side of the patient'"'"'s circulatory system to isolate the first segment of the patient'"'"'s circulatory system from the second segment of the patient'"'"'s circulatory system.

37. The method of claim 22, further comprising expanding an external catheter valve on the venous side of the patient'"'"'s circulatory system to isolate the first segment of the patient'"'"'s circulatory system from the second segment of the patient'"'"'s circulatory system.

38. The method of claim 22, wherein:

the first venous location comprises the patient'"'"'s superior vena cava;

the second venous location comprises the patient'"'"'s inferior vena cava;

the first arterial location comprises the patient'"'"'s aortic arch and arch vessels; and

the second arterial location comprises the patient'"'"'s descending aorta and branch vessels.

39. The method of claim 38, further comprising draining a third portion of the patient'"'"'s blood and returning the third portion of the patient'"'"'s blood to the patient'"'"'s coronary arteries.

40. The method of claim 39, further comprising draining the third portion of the patient'"'"'s blood from the patient'"'"'s coronary sinus.

41. The method of claim 38, further comprising:

conditioning the first portion of the patient'"'"'s blood to a temperature of approximately 32°

C. or lower; and

conditioning the second portion of the patient'"'"'s blood to a temperature of approximately 32 to 37°

C.

42. The method of claim 38, further comprising:

adding neuroprotective agents to the first portion of the patient'"'"'s blood.

43. The method of claim 38, further comprising:

infusing a cardioplegic/agent into the patient'"'"'s coronary arteries.

44. The method of claim 38, further comprising:

infusing a cardioplegic agent into the patient'"'"'s coronary sinus.

45. The method of claim 22, further comprising:

sensing a condition of the first portion of the patient'"'"'s blood from the first venous location in the first segment of the patient'"'"'s circulatory system; and

sensing a condition of the second portion of the patient'"'"'s blood from the second venous location in the second segment of the patient'"'"'s circulatory system.

46. The method of claim 45, further comprising:

sensing a condition of the first portion of the patient'"'"'s blood returned to the first arterial location in the first segment of the patient'"'"'s circulatory system; and

sensing a condition of the second portion of the patient'"'"'s blood returned to the second arterial location in the second segment of the patient'"'"'s circulatory system.