Triple-lumen intra-aortic catheter

• US 5,697,905 A
• Filed: 06/19/1995
• Issued: 12/16/1997
• Est. Priority Date: 06/19/1995
• Status: Expired due to Fees

• Current Assignee: Cardeon Corporation
• Original Assignee: Leo T D'Ambrosio
• Inventors: d'Ambrosio, Leo T.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/491,520
• Time in Patent Office: 911 Days
• Field of Search: 604/96, 604/101, 604/102, 604/27, 604/28, 604/35, 604/43
• US Class Current: 604/96.01
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A method and apparatus used during cardiac surgery for reducing release of embolized air and particulate matter into general body circulatory system are disclosed. The method uses a catheter apparatus having an inflation lumen, an occlusive balloon, a suction lumen and a perfusion lumen. The catheter is inserted or navigated to into an aortic root and positioned so a suction opening communicates upstream of the aortic root and a perfusion opening communicates downstream of the suction opening. The patient'"'"'s heart is stopped and the occlusive balloon is inflated to occlude the aorta. Cardiac surgery is performed and when the patient'"'"'s heart is restarted the blood pumped by the heart during its first few contractions is suctioned through the suction opening. This initial blood pumped by the heart often contains embolized air and particulate matter which can cause a stroke or subtle cognitive changes if allowed to enter the general circulatory system.

Claims

1. A method for reducing release of embolized air and particulate matter from a heart into general body circulatory system during cardiac surgery, comprising the steps of:

(a) providing a triple-lumen intra-aortic catheter that comprises;

(1) an inflation lumen having a distal end and a proximate end connected to an inflation source,

(2) an occlusive balloon connected to the inflation lumen distal end receiving fluid from the inflation lumen proximate end which is connected to the inflation source to inflate the occlusive balloon to occlude an artery,

(3) a suction lumen having a distal end with a suction opening and a proximate end connected to a suction source, and,

(4) a perfusion lumen having a distal end with a perfusion opening downstream of the suction opening and a proximate end connected to a cardiopulmonary bypass machine;

(b) inserting the triple-lumen intra-aortic catheter into an insertion point in the body and navigating the occlusive balloon to a position in the vicinity of a proximal end of an aortic root;

(c) stopping heart operation while a patient is connected to the cardiopulmonary bypass machine and the triple-lumen intra-aortic catheter is inserted;

(d) inflating an occlusive balloon with a fluid to block blood flow from the heart through an aortic artery into the general body circulatory system;

(e) perfusing oxygenated blood from the cardiopulmonary bypass machine into the aorta downstream of the occlusive balloon during heart surgery to supply the general body circulatory system with oxygenated blood;

(f) performing surgical procedures on the heart while the heart is stopped and the triple-lumen intra-aortic catheter is inserted in the vicinity of the proximal end of the aortic root, the occlusive balloon is inflated and the perfusion lumen is perfusing oxygenated blood from the cardiopulmonary bypass machine into the aorta downstream of the occlusive balloon;

(g) restarting heart operation after surgical procedures on the heart have been completed and the occlusive balloon continues to be inflated and the perfusion lumen continues to perfuse oxygenated blood;

(h) suctioning blood from an initial heart pumping by applying the suction source through the suction lumen to draw the blood into a receptacle so the release of embolized air and particulate matter into the body general circulatory system during cardiac surgery is reduced which decreases end organ injury complications following cardiac surgery;

(i) deflating the occlusive balloon by removing fluid from the occlusive balloon through the inflation lumen; and

,

(j) removing the triple-lumen intra-aortic catheter from the proximal end of the aortic root and navigating the triple-lumen intra-aortic catheter out of the body through the insertion point.

2. The method as in claim 1 wherein 200-300 cc of blood is suctioned during initial heart pumping.

3. The method as in claim 1 wherein the suction source applies about 40-60 mm Hg to the suction lumen to suction blood during initial heart operation after the heart has been restarted.

4. The method as in claim 1 wherein the suction lumen fluid is a normal saline solution to reduce the possibility of air pockets forming in the suction lumen.

5. The method as in claim 1 wherein inflating the occlusive balloon blocks blood flow through the aortic artery eliminating a step of clamping the aorta root to block blood flow during cardiac surgery.

6. The method as in claim 1 wherein the inflation lumen has a smaller diameter than the suction lumen and the suction lumen has a smaller diameter than the perfusion lumen.

7. The method as in claim 1 wherein the cardiac surgery is selected from the group consisting of:

open heart surgery, cardio-pulmonary bypass surgery, coronary artery bypass surgery, heart valve corrective surgery, endocardial septal defect surgery, and pediatric heart surgery.

8. The method as in claim 1 wherein the end organ injury complications are central nervous system complications.

9. The method as in claim 8 wherein the central nervous system complications are strokes and subtle cognitive changes.

10. The method as in claim 1 wherein the suction lumen distal end opening passes through a central balloon opening to permit suctioning of blood upstream of the balloon while the balloon is still inflated.

11. The method as in claim 1 wherein the perfusion lumen distal end opening is offset downstream from the occlusive balloon a distance to position the perfusion lumen distal end opening near a first branch point of an innominate artery to facilitate perfusion into the body general circulatory system.

12. The method as in claim 11 wherein the distance is in the range from 5-6 cm.

13. The method as in claim 1 wherein the triple-lumen intra-aortic catheter has a cross-section that is substantially round that is about 0.7 cm in diameter.

14. The method as in claim 1 further comprising a guide wire that is inserted into the triple-lumen intra-aortic catheter during the step of inserting the triple-lumen intra-aortic catheter for use in navigating the triple-lumen intra-aortic catheter.

15. The method as in claim 1 wherein the triple-lumen intra-aortic catheter is used for a severely atherosclerotic aorta.

16. The method as in claim 1 wherein the occlusive balloon is positioned between the suction lumen distal end suction opening and the perfusion lumen distal end perfusion opening.

17. The method as in claim 16 wherein when the occlusive balloon is inflated an aortic root is partitioned so the suction lumen distal end suction opening communicates upstream of the occlusive balloon with a heart and the perfusion lumen distal end perfusion opening communicates downstream of the occlusive balloon with the general body circulatory system.

18. The method as in claim 1 wherein the triple-lumen intra-aortic catheter is inserted directly into an aortic root.

19. The method as in claim 1 wherein the triple-lumen intra-aortic catheter is placed in a body that has a substantially healthy aorta.

20. A triple-lumen intra-aortic catheter, comprising:

(a) an inflation lumen having a distal end and a proximate end connected to an inflation source;

(b) an occlusive balloon connected to the inflation lumen distal end receiving fluid from the inflation lumen proximate end connected to the inflation source to inflate the occlusive balloon to occlude an artery and to reduce the movement of particulates around the balloon;

(c) a perfusion lumen having a distal end with a perfusion opening downstream of the occlusive balloon and a proximate end connected to a cardiopulmonary bypass machine; and

,

(d) a suction lumen having a distal end with a suction opening upstream of the occlusive balloon and perfusion opening and a proximate end connected to a suction source.

21. The triple-lumen intra-aortic catheter as in claim 20 wherein the suction lumen distal end opening passes through a central balloon opening to permit suction of blood from the heart upstream of the balloon while the balloon is still inflated.

22. The triple-lumen intra-aortic catheter as in claim 20 wherein the perfusion lumen distal end opening is offset downstream from the occlusive balloon a distance to position the perfusion lumen distal end opening near a first branch point of an innominate artery to facilitate perfusion into the body general circulatory system.

23. The triple-lumen intra-aortic catheter as in claim 20 wherein the occlusive balloon is positioned between the suction lumen distal end suction opening and the perfusion lumen distal end perfusion opening.

24. The triple-lumen intra-aortic catheter as in claim 20 wherein when the occlusive balloon is inflated an aortic root is partitioned so the suction lumen distal end suction opening communicates upstream of the occlusive balloon with a heart and the perfusion lumen distal end perfusion opening communicates downstream of the occlusive balloon with the general body circulatory system.