Methods and Apparatus for Percutaneous Aortic Valve Replacement

• US 20140142692A1
• Filed: 01/14/2014
• Published: 05/22/2014
• Est. Priority Date: 07/23/2007
• Status: Active Grant

• Current Assignee: Hocor Cardiovascular Technologies, LLC
• Original Assignee: Hocor Cardiovascular Technologies, LLC
• Inventors: HO, Paul C.
• Granted Patent: US 9,480,564 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/006 modular

Abstract

A delivery system and method for percutaneous aortic valve (PAV) replacement and apparatus used therein. A temporary aortic valve including a reversibly expandable occluding means surrounds a central catheter mechanism. The temporary valve is positioned within the ascending aorta, just above and downstream from the coronary ostia. The occluding means is configured such that, when fully expanded against the aortic wall, gaps are left that promote continuous coronary perfusion during the cardiac cycle. The temporary valve substitutes for the function of the native aortic valve during its replacement. The native aortic valve is next dilated, and then ablated through deployment of low profile, elongated, sequentially delivered stents. The stent(s) displace the native tissues and remain within the aortic annulus to receive and provide a structure for retaining the PAV. The PAV is delivered, positioned and deployed within the stent(s) at the aortic annulus with precision and relative ease.

Claims

1. A system for replacing a heart valve, having an annulus, with a prosthetic valve, the system comprising:

at least one temporary valve (TV) including a central delivery catheter and an occluder configured to be reversibly expanded in a vessel in proximity to the annulus to partially occlude the vessel, the TV being configured to be delivered and removed percutaneously with the occlude in contracted states; and

at least one low-profile stent configured to be deployed through the central delivery catheter into the annulus of the heart valve.

2. The system of claim 1, wherein the at least one low-profile stent includes a plurality of low-profile stents configured to be delivered and deployed concentrically in the annulus of the heart valve.

3. The system of claim 2, wherein the heart valve includes a plurality of leaflets and wherein each of the plurality of low-profile stents has a radial strength insufficient to fully open the plurality of leaflets and the plurality of low-profile stents together has a total radial strength sufficient to fully open the plurality of leaflets and prevent recoil of the annulus and the plurality of leaflets of the valve.

4. The system of claim 2, wherein the plurality of low-profile stents has a plurality of radial strengths.

5. The system of claim 2, wherein the plurality of low-profile stents has a plurality of profiles.

6. The system of claim 1, wherein the at least one low-profile stent is configured to have an elongated shape during delivery and a foreshortened shape after deployment.

7. The system of claim 1, wherein the at least one low-profile stent comprises an ablation stent.

8. The system of claim 1, wherein the at least one low-profile stent is fabricated from a high strength composite material.

9. The system of claim 1, wherein the at least one low-profile stent has drug elution capabilities.

10. The system of claim 1, wherein the at least one low-profile stent is configured to be delivered through the central delivery catheter, wherein the central delivery catheter has a diameter less than 18 French.

11. The system of claim 10, wherein the central delivery catheter has a diameter of not more than 8 French.

12. The system of claim 11, wherein the central delivery catheter has a diameter of not more than 12 French.

13. The system of claim 1, wherein the TV is fabricated from a high strength composite material.

14. The system of claim 1, wherein the heart valve comprises an aortic valve.

15. The system of claim 14, wherein the TV comprises a temporary aortic valve (TAV), the vessel is in an aorta, and the TAV is configured to be deployed above and in proximity to a Sinus of Valsalva of the aorta.

16. The system of claim 15, wherein the occluder of the TAV occludes a potion of the aorta such that at least one gap occupying not less than 25% and not more than 60% of a cross-sectional area of the aorta are formed.

17. The system of claim 16, wherein the at least one gap occupies substantially 35% of the cross-sectional area of the aorta.

18. The system of claim 16, wherein the aortic valve area is 3 cm² and the cross-sectional area of the at least one gap left by the plurality of expandable occlusion elements when fully expanded is at least 0.75 cm².

19. The system of claim 1, wherein the occluder comprises a plurality of expandable occlusion elements.

20. The system of claim 19, wherein the plurality of expandable occlusion are distributed around the central delivery catheter.

21. The system of claim 19, wherein the plurality of expandable occlusion elements comprises a plurality of inflatable balloons.

22. The system of claim 19, wherein the plurality of expandable occlusion elements comprise three occlusion elements of equal size and are arranged to provide gaps therebetween to allow continuous blood perfusion.

23. The system of claim 1, wherein the plurality of expandable occlusion elements comprises three occlusion elements of unequal size and are arranged to provide gaps therebetween to allow continuous blood perfusion.