System for performing a cardiac procedure

• US 5,458,574 A
• Filed: 03/16/1994
• Issued: 10/17/1995
• Est. Priority Date: 03/16/1994
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Machold, Timothy R., Sterman, Wesley D.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/213,760
• Time in Patent Office: 580 Days
• Field of Search: 604/96, 604/101, 604/104, 604/53, 604/49, 604/264, 604/280, 606/191-194, 128/656, 128/657, 128/658
• US Class Current: 604/101.03
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2202/047 cardioplegic
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A system for accessing a patient'"'"'s cardiac anatomy which includes an occlusion catheter with a first expandable member or balloon in a distal extremity of the catheter which when expanded within the patient'"'"'s ascending aorta separates the heart and coronary blood vessels from the rest of the patient'"'"'s arterial system, and a second expandable member, distal to the first, which when expanded will be seated within the left ventricle. A cardiopulmonary bypass system is connected to a major vein, e.g. femoral, to withdraw blood, remove carbon dioxide, oxygenate the withdrawn blood and then return the oxygenated blood to the patient'"'"'s arterial system through a major artery. Preferably, the heart muscle or myocardium is paralyzed by the antegrade and/or retrograde delivery of a liquid containing cardioplegic material to the myocardium through patient'"'"'s coronary arteries or coronary sinus. The cardiac accessing system is suitable for a wide variety of cardiac procedures including opened and closed chest procedures.

Claims

1. An endovascular intra-aortic catheter system for providing access to a patient'"'"'s heart through an aortic passageway leading away from an aortic valve in the patient'"'"'s heart while isolating the heart from the patient'"'"'s arterial system, comprising:

a) an elongated catheter shaft which is advanceable through the aortic passageway leading away from the aortic valve of the patient'"'"'s heart, which has a proximal portion adapted to extend out of the patient and a distal portion adapted to be disposed within the patient'"'"'s ascending aorta and left ventricle, and which has a first inner lumen extending therein from a port in the distal portion of the catheter shaft to a location in the proximal portion;

b) a first expandable member on the distal portion of the catheter shaft spaced proximally from the port in the distal portion which is dimensioned and configured so that it occludes the aortic passageway within the ascending aorta when expanded; and

c) a second expandable member on the distal portion of the catheter shaft located proximally of the port in the distal portion and distally to the first expandable means and which is dimensioned and configured so that it seats within the left ventricle when expanded to secure the catheter as to minimize catheter movement within the aortic passageway, wherein said first and second expandable members are spaced-apart from each other by a distance sufficient to permit positioning in the aortic passageway and the left ventricle, respectively.

2. The catheter system of claim 1 wherein the first expandable member is an inflatable balloon having an interior which is in fluid communication with an inflation lumen extending within the catheter shalt from a location within the interior of the first expandable member to a location in the proximal portion which is adapted to extend out of the patient.

3. The catheter system of claim 1 wherein the second expandable member is an inflatable balloon having an interior in fluid communication with an inflation lumen extending within the catheter shaft from a location within the interior of the first expandable member to a location in the proximal portion which is adapted to extend out of the patient.

4. The catheter system of claim 1 wherein a second port is provided in the catheter shaft between the first and second expandable members and a fluid delivery lumen extends within the catheter shaft from the second port to a location within the proximal portion of the catheter shaft extending out of the patient.

5. The catheter system of claim 1 wherein the first and second expandable members are inflatable balloons having interiors, the catheter shaft further comprising an inflation lumen which is in fluid communication with the interiors of the first and second expandable members.

6. The catheter system of claim 5 wherein the inflation lumen extends to a location within the proximal shaft section which extends out of the patient.

12. The catheter system of claim 1 wherein the distal side of the first expandable member is axially spaced-apart from a proximal side of the second expandable member by a distance in the range from 1 cm to 8 cm.

13. The catheter system of claim 12 wherein the distal side of the first expandable member is axially spaced-apart from a proximal side of the second expandable member by a distance in the range from 3 cm to 5 cm.

7. An endovascular catheter system for providing access to a patient'"'"'s heart through the patient'"'"'s ascending aorta, comprising:

a) an elongated catheter shaft which has at least one inner lumen extending therein and which is dimensioned and configured to be advanceable through an aortic passageway leading away from the patient'"'"'s heart through the ascending aorta;

b) a first expandable member on a distal portion of the catheter shaft which is dimensioned and configured to occlude the aortic passageway when expanded therein;

c) a second expandable member on the distal portion of the catheter shaft, distal to the first expandable means, which is dimensioned and configured to seat within the left ventricle adjacent to the aortic valve when expanded to minimize movement of the catheter within the aortic passageway;

d) a port in the distal portion of the catheter shaft distal to the second expandable member in fluid communication with the inner lumen which is adapted to withdraw fluid outside of the catheter into the inner lumen; and

e) a second port in the catheter shaft between the first and second expandable members in communication with a second inner lumen extending within the catheter shaft and adapted to infuse a fluid into the aortic passageway between the first and second expandable members.

8. The catheter system of claim 7 wherein the first expandable member is an inflatable balloon having an interior in fluid communication with an inflation lumen extending within the catheter shaft.

9. The catheter system of claim 7 wherein the second expandable member is an inflatable balloon having an interior in fluid communication with an inflation lumen extending within the catheter shaft.

10. The catheter system of claim 7 wherein the first expandable member is an inflatable balloon having an interior in fluid communication with a first inflation lumen extending within the catheter shaft and the second expandable member is an inflatable balloon having an interior in fluid communication with a second inflation lumen extending within the catheter shaft, such that the first and second expandable members are independently expandable.

11. The catheter system of claim 7 wherein the first expandable member is separated from the second expandable member by a distance selected to allow the first expandable member to be positioned between the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery when the second expandable member is seated adjacent an upstream side of the patient'"'"'s aortic valve.

14. The catheter system of claim 7 wherein the distal side of the first expandable member is axially spaced-apart from a proximal side of the second expandable member by a distance in the range from 1 cm to 8 cm.

15. The catheter system of claim 14 wherein the distal side of the first expandable member is axially spaced-apart from a proximal side of the second expandable member by a distance in the range from 3 cm to 5 cm.

16. A system for preparing a patient for a cardiac procedure, comprising:

a) an elongated aortic occlusion catheter adapted to be advanced to a location within a patient'"'"'s ascending aorta, having proximal and distal ends, having a first inner lumen extending therein to a distal port in the distal end of the catheter, having a first expandable member on a distal portion thereof which when expanded within the patient'"'"'s ascending aorta occludes the aortic passageway, having a second expandable member distal to the first expandable member which is configured so that it seats within the patient'"'"'s left ventricle when expanded so as to minimize catheter movement within the aortic passageway, and having a second inner lumen extending therein to a perfusion port disposed between said first and second expandable members;

b) a cardiopulmonary bypass system having means to withdraw blood from the patient'"'"'s venous system, means to oxygenate the withdrawn blood and means to direct the oxygenated blood into the patient'"'"'s arterial system; and

c) means connected to the second inner lumen to deliver cardioplegic material to the patient'"'"'s myocardium.

17. The system of claim 16 wherein the first expandable member on the elongated aorta occlusion catheter is an inflatable member.

18. The system of claim 17 wherein the elongated aortic occlusion catheter has a third inner lumen adapted to direct inflation fluid to the interior of the first expandable member.

19. The system of claim 16 wherein the second expandable member is an inflatable member.

20. The system of claim 19 wherein the elongated aortic occlusion catheter has a fourth inner lumen adapted to direct inflation fluid to the interior of the second expandable member.

21. The system of claim 16 wherein the elongated aortic occlusion catheter is adapted to withdraw blood from the left ventricle through the first inner lumen thereof and direct the withdrawn blood outside of the patient'"'"'s body.

22. The system of claim 21 including means to return the withdrawn blood to the patient'"'"'s vasculature.

23. A method of accessing a patient'"'"'s coronary anatomy comprising:

a) advancing to a location within a patient'"'"'s ascending aorta and left ventricle an elongated catheter which has proximal and distal ends, which has an inner lumen extending therein to a port in the distal end and which has first and second expandable members on a distal portion thereof;

b) expanding the first expandable member within the patient'"'"'s ascending aorta between the coronary ostia and brachiocephalic artery to block blood flow therethrough; and

c) expanding the second expandable member within the patient'"'"'s left ventricle to seat the expanded second member therein.

24. The method of claim 23 further comprising paralyzing the patient'"'"'s myocardium.

25. The method of claim 24 wherein the step of paralyzing comprises infusing cardioplegic fluid into the ascending aorta through at least one port in the catheter between the first and second expandable members so as to perfuse the patient'"'"'s myocardium with the cardioplegic fluid through at least one coronary artery.

26. The method of claim 23 further comprising withdrawing fluid through the port in the distal end of the catheter and through the inner lumen to a location outside of the patient'"'"'s body.

27. The method of claim 23 further comprising passing surgical instruments through the inner lumen of the catheter to a location within the patient'"'"'s left ventricle.

28. A method for performing an endovascular cardiac procedure on a patient, comprising:

a) advancing to a location within a patient'"'"'s ascending aorta and left ventricle an elongated delivery catheter which has proximal and distal ends, which has an inner lumen extending therein to a port in the distal end and which has first and second expandable members on a distal portion thereof;

b) expanding the first expandable member within the patient'"'"'s ascending aorta between the coronary ostia and brachiocephalic artery to block blood flow therethrough; and

c) expanding the second expandable member within the patient'"'"'s left ventricle to seat the expanded second member therein;

d) withdrawing blood from the patient'"'"'s venous system, oxygenating the withdrawn blood and returning the oxygenated blood to the patient'"'"'s arterial system; and

e) passing one or more instruments for performing the cardiac procedure through the inner lumen of the delivery catheter.

29. The method of claim 28 further comprising paralyzing the patient'"'"'s myocardium.

30. The method of claim 29 wherein the step of paralyzing comprises infusing cardioplegic fluid into the ascending aorta through at least one port in the catheter between the first and second expandable members so as to perfuse the patient'"'"'s myocardium through at least one coronary artery.