Cardiopulmonary catheter system

• US 6,071,271 A
• Filed: 09/05/1997
• Issued: 06/06/2000
• Est. Priority Date: 09/05/1996
• Status: Expired due to Term

• Current Assignee: Baxter Research Medical, Inc. (Edwards Lifesciences Corporation)
• Original Assignee: Baxter Research Medical, Inc. (Edwards Lifesciences Corporation)
• Inventors: Crocker, Gary L., Baker, Clyde, Swindle, Carl A.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/924,383
• Time in Patent Office: 1,005 Days
• Field of Search: 604/500, 604/506, 604/507, 604/508, 604/96, 604/523, 604/532, 604/536
• US Class Current: 604/500
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 2210/127 Aorta
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A catheter system for use in minimally invasive cardiac surgical procedures. The catheter system diminishes certain trauma generally associated with invasive cardiac procedures while providing aortic occlusion, extracorporeal circulation, cardiac arrest, and cardiac venting. The catheter system provides a minimally invasive and simplified system that performs total cardiopulmonary bypass with ease of insertion, improved whole body profusion, and shortened recovery periods. The catheters are refined, with reduced diameters and specialized functions for maximum control of each aspect of cardiopulmonary bypass.

Claims

1. A system for employing blood management during cardiac surgical procedures comprising at least:

a. an aortic occlusion catheter designed for percutaneous introduction into a peripheral vessel and for antegrade introduction of cardioplegia solution into the coronary arteries, said aortic occlusion catheter being advantageously positioned in the ascending aorta, and further providing a balloon positioned at the base of the ascending aorta just cephalid to the junction of the coronary arteries, said balloon providing for occlusion of the ascending aorta upon inflation;

b. a femoral access arterial return catheter designed for percutaneous introduction into a femoral artery, said femoral access arterial return catheter positioned within a femoral artery and extended slightly therein to facilitate perfusion of the body with oxygenated blood, and terminating in a flexible tip comprising at least one exit hole designed to deter expulsive oxygenated blood flow therefrom; and

c. a femoral access venous return catheter designed for percutaneous introduction into a femoral vein, said femoral access venous return catheter terminating in a flexible tip comprising a plurality of inlet openings to accommodate venous blood drainage from a right atrium.

2. A system as recited in claim 1, wherein said femoral access venous return catheter is equipped with an inflatable balloon positioned caudal to the entrance of the inferior vena cava in the right atrium such that isolation of the right atrium is facilitated.

3. A system as recited in claim 1, further comprising a jugular access perfusion catheter positioned for directing flow of cardioplegia into the coronary sinus.

4. A system as recited in claim 3, wherein said jugular access perfusion catheter comprises a balloon positioned within the coronary sinus such that fluid flow is occluded from the coronary sinus into the right atrium.

5. A system as recited in claim 4, wherein said jugular access perfusion catheter comprises an inflation balloon positioned cephalid to the opening of the superior vena cava into the right atrium such that isolation of the right atrium is facilitated.

6. A system as recited in claim 1, wherein said aortic occlusion catheter terminates in a flexible tip positioned just proximal to a patient'"'"'s coronary arteries.

7. A system as recited in claim 1, wherein said aortic occlusion catheter further comprises a diameter which is minimized for avoiding injury, plaque removal, and distortion of the aorta and the axillary, brachial and left subclavian arteries.

8. A system as recited in claim 7, wherein said diameter is from about 7 to about 18 French.

9. A system as recited in claim 7, wherein said diameter is from about 9 to about 15 French.

10. A system as recited in claim 7, wherein said diameter is about 14 French.

11. A system as recited in claim 1, wherein said aortic occlusion catheter comprises three lumens.

12. A system as recited in claim 1, wherein said aortic occlusion catheter comprises two lumens.

13. A system as recited in claim 1, wherein said aortic occlusion catheter is designed to provide venting of the left heart.

40. A system as recited in claim 1, wherein the peripheral vessel into which the aortic occlusion catheter is designed to be introduced is the left subclavian artery.

14. A method for employing blood management during cardiac surgical procedures comprising the steps of:

a. inserting an aortic occlusion catheter comprising a flexible tip, an inflatable balloon positioned at the base of the ascending aorta just cephalid to the junction of the coronary arteries, and at least one infusion outlet positioned proximal to said balloon, into a peripheral vessel;

i. advancing the aortic occlusion catheter until the tip abuts the aortic semilunar valve,

ii. pulling back on the aortic occlusion catheter such that the tip is just proximal to the coronary arteries and said inflatable balloon is positioned in the ascending aorta,

iii. inflating said inflatable balloon to occlude the ascending aorta,

iv. arresting the heart utilizing antegrade infusion of cardioplegia solution, and

v. venting the left heart;

b. inserting a femoral access arterial return catheter comprising a flexible tip including at least one exit hole designed to deter expulsive oxygenated blood flow therefrom into a femoral artery;

c. inserting a femoral access venous return catheter comprising a flexible tip including a plurality of inlet openings for accommodating venous blood drainage from the right atrium into a femoral vein; and

d. initiating cardiopulmonary bypass.

15. A method as recited in claim 14, wherein said femoral access venous return catheter is equipped with an inflatable balloon positioned caudal to the entrance of the inferior vena cava in the right atrium.

16. A method as recited in claim 15, further comprising the step of inflating the inflatable balloon of the femoral access venous return catheter to isolate the right atrium.

17. A method as recited in claim 14, further comprising a jugular access perfusion catheter positioned for directing flow of cardioplegia solution into the coronary sinus, and comprising a balloon positioned within the coronary sinus.

18. A method as recited in claim 17, further comprising the step of inflating the balloon positioned within the coronary sinus to occlude fluid flow from the coronary sinus into the right atrium.

19. A method as recited in claim 18, further comprising the step of perfusing the heart with cardioplegia solution through said jugular access perfusion catheter.

20. A method as recited in claim 17, wherein said jugular access perfusion catheter comprises an inflation balloon positioned cephalid to the opening of the superior vena cava into the right atrium.

21. A method as recited in claim 20, further comprising the step of inflating the inflation balloon of said jugular access perfusion catheter for isolation of the right atrium.

22. A method as recited in claim 14, wherein said peripheral vessel is the left subclavian artery.

23. A method as recited in claim 14, wherein said peripheral vessel is an axillary artery.

24. A method as recited in claim 14, wherein said peripheral vessel is a brachial artery.

25. A method as recited in claim 14, wherein said aortic occlusion catheter further comprises a diameter which is minimized for avoiding injury, plaque removal, and distortion of the aorta and the left sublavian, axillary, and brachial arteries.

26. A system for employing blood management during cardiac surgical procedures comprising:

a. an aortic occlusion catheter designed for percutaneous introduction into a peripheral vessel and for antegrade introduction of cardioplegia solution into the coronary arteries, said aortic occlusion catheter being advantageously positioned in the ascending aorta and further providing a balloon positioned at the base of the ascending aorta just cephalid to the junction of the coronary arteries, said balloon providing for occlusion of the ascending aorta upon inflation;

b. a femoral access arterial return catheter designed for percutaneous introduction into a femoral artery, said femoral access arterial return catheter positioned within a femoral artery and extended slightly therein to facilitate perfusion of the body with oxygenated blood, and said femoral access arterial perfusion catheter terminating in a flexible tip comprising at least one exit hole designed to deter expulsive oxygenated blood flow therefrom;

c. a femoral access venous return catheter designed for percutaneous introduction into a femoral vein, said femoral access venous return catheter terminating in a flexible tip comprising a plurality of inlet openings to accommodate venous blood drainage from a right atrium; and

d. a jugular access perfusion catheter positioned for directing flow of cardioplegia solution into the coronary sinus, said jugular access perfusion catheter further including a balloon positioned within the coronary sinus such that fluid flow is occluded from the coronary sinus into the right atrium.

27. A system as recited in claim 26, wherein said femoral access venous return catheter is designed for extension into a right atrium.

28. A system as recited in claim 26, wherein said femoral access venous return catheter is equipped with an inflatable balloon positioned caudal to the entrance of the inferior vena cava in the right atrium such that isolation of the right atrium is facilitated.

29. A system as recited in claim 26, wherein said jugular access perfusion catheter comprises an inflation balloon positioned cephalid to the opening of the superior vena cava into the right atrium such that isolation of the right atrium is facilitated.

30. A method for employing blood management during cardiac surgical procedures comprising the steps of:

a. inserting an aortic occlusion catheter comprising a flexible tip, an inflatable balloon positioned at the base of the ascending aorta just cephalid to the junction of the coronary arteries, and at least one infusion outlet positioned proximal to said balloon, into a peripheral vessel;

i. advancing the aortic occlusion catheter until the tip abuts the aortic semilunar valve,

ii. pulling back on the aortic occlusion catheter such that the tip is just proximal to the coronary arteries and said inflatable balloon is positioned in the ascending aorta,

iii. inflating said inflatable balloon to occlude the ascending aorta,

iv. arresting the heart utilizing antegrade infusion of cardioplegia solution, and

v. venting the left heart;

b. inserting a femoral access arterial return catheter comprising a flexible tip including at least one exit hole designed to deter expulsive oxygenated blood flow therefrom into a femoral artery;

c. inserting a femoral access venous return catheter comprising a flexible tip including a plurality of inlet openings for accommodating venous blood drainage from the right atrium into a femoral vein;

d. inserting a jugular access perfusion catheter comprising a balloon positioned within the coronary sinus into a jugular vein, and

i. inflating the balloon of the jugular access catheter to occlude fluid flow from the coronary sinus into the right atrium; and

e. initiating cardiopulmonary bypass.

31. A method as recited in claim 30, wherein said femoral access venous return catheter is equipped with an inflatable balloon positioned caudal to the entrance of the inferior vena cava in the right atrium.

32. A method as recited in claim 31, further comprising the step of inflating the inflatable balloon of the femoral access venous return catheter to isolate the right atrium.

33. A method as recited in claim 30, wherein said jugular access perfusion catheter comprises an inflation balloon positioned cephalid to the opening of the superior vena cava into the right atrium.

34. A method as recited in claim 33, further comprising the step of inflating the inflation balloon of said jugular access perfusion catheter for isolation of the right atrium.

35. A method as recited in claim 33, further comprising the step of perfusing the heart with cardioplegia solution through said jugular access perfusion catheter.

36. A method as recited in claim 30, wherein said peripheral vessel is the left subclavian artery.

37. A method as recited in claim 30, wherein said peripheral vessel is an axillary artery.

38. A method as recited in claim 30, wherein said peripheral vessel is a brachial artery.

39. A method as recited in claim 30, wherein said aortic occlusion catheter further comprises a diameter which is minimized for avoiding injury, plaque removal, and distortion of the aorta and the left subclavian, brachial and axillary arteries.