Method and system for balloon counterpulsation during aortic valve replacement

• US 9,308,086 B2
• Filed: 09/07/2011
• Issued: 04/12/2016
• Est. Priority Date: 09/21/2010
• Status: Active Grant

• Current Assignee: Hocor Cardiovascular Technologies, LLC
• Original Assignee: Hocor Cardiovascular Technologies, LLC
• Inventors: Ho, Paul C.
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US13/227,276
• Publication Number:
  US 20120116439A1
• Time in Patent Office: 1,679 Days
• Field of Search: 606191-192, 606/194, 604/914, 600 16- 18
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Methods and systems for regulating aortic regurgitation during aortic valve replacement or repair procedures utilize a temporary aortic valve (TAV) catheter and a controller. The temporary aortic valve catheter has an expandable occlusion device which can partially occlude the aortic lumen during ventricular diastole with a lesser occlusion during ventricular systole. Exemplary balloon structures include multiple, independently inflatable balloons which are inflated in synchrony with the cardiac cycle by the controller. By controlling aortic regurgitation, the repair or replacement protocols can be conducted with less interference from blood flow.

Claims

1. A method for regulating aortic regurgitation, said method comprising:

positioning a catheter comprising a tubular body and a variable occlusion device in the ascending aorta above the sinus of valsalva, the variable occlusion device comprising first and second expandable occlusion elements disposed in parallel about the tubular body;

expanding the first and second occlusion elements to partially occlude the aortic lumen about the tubular body of the catheter during ventricular diastole to inhibit aortic regurgitation while allowing perfusion of the coronary arteries via the sinus of valsalva;

contracting the first occlusion element while the second occlusion element remains expanded to reduce occlusion of the aortic lumen during ventricular systole to lessen inhibition of blood flow from the left ventricle to the aorta;

performing a replacement or repair procedure while alternating expanding and contracting the first occlusion element in synchrony with diastole and systole as the second occlusion element remains expanded.

2. A method as in claim 1, wherein the occlusion device is expanded to occlude from 40% to 90% of the aortic lumen during ventricular diastole and is contracted to reduce occlusion to below 75% of the aortic lumen during ventricular systole.

3. A method as in claim 2, wherein the occlusion device is contracted to reduce occlusion below 65% during ventricular systole.

4. A method as in claim 3, wherein the occlusion device is contracted to reduce occlusion below 50% during ventricular systole.

5. A method as in claim 4, wherein the occlusion device is contracted to reduce occlusion below 25% during ventricular systole.

6. A method as in claim 2, wherein one or more of the first or second occlusion element of the variable occlusion device comprises at least one inflatable element.

7. A method as in claim 2, wherein one or more of the first or second occlusion element of the variable occlusion device comprises a plurality of independently inflatable elements.

8. A method as in claim 7, wherein the plurality of inflatable elements are inflated and deflated simultaneously.

9. A method as in claim 7, wherein individual ones of the elements are inflated while other ones of the elements are deflated.

10. A method as in claim 7, wherein at least some elements remain inflated at all times to stabilize the occlusion device position within the ascending aorta.

11. A method as in claim 1, wherein positioning the catheter comprises advancing the catheter over the aortic arch.

12. A method as in claim 1, wherein positioning the catheter comprises advancing the catheter transapically.

13. A method as in claim 1, wherein performing the replacement or repair comprises advancing a replacement valve through a lumen of the catheter.

14. A method as in claim 1, further comprising removing the native valve, wherein expanding and contracting the occlusion device continues after the valve has been removed.

15. A method as in claim 1, wherein the first and second occlusion elements are disposed in parallel about a distal end of the catheter.

16. A method as in claim 1, wherein the first and second occlusion elements are disposed symmetrically about a distal end of the catheter.