METHOD AND APPARATUS FOR PERCUTANEOUS AORTIC VALVE REPLACEMENT

• US 20090030503A1
• Filed: 07/23/2007
• Published: 01/29/2009
• 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 8,663,318 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/22055 with three or more balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• 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

Abstract

A method for percutaneous aortic valve (PAV) replacement and a temporary aortic valve used to facilitate the same. The temporary valve is comprised of a reversibly expandable occluding means, such as balloons, surrounding 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 native aortic valve is next dilated, and then ablated through deployment of an ablation stent. The ablation stent displaces the native valve tissues and remains within the aortic annulus to receive and retain the PAV. The PAV can then be positioned and deployed within the ablation stent with precision and ease. Ablation of the native aortic valve removes the structural obstacles to precise PAV placement. The temporary aortic valve mediates the hemodynamic forces encountered by the surgeon following native valve ablation. The temporary valve also promotes patient stability through continuous coronary perfusion and a moderated transvavlular pressure gradient. Mathematical considerations for determining the optimum cross-sectional area for the temporary valve blood perfusion gaps are also described.

Claims

1. A temporary aortic valve for placement in the ascending aorta to facilitate percutaneous aortic valve replacement comprising a reversibly expandable occluding means surrounding a central catheter mechanism, wherein said occluding means in contracted mode is delivered and withdrawn percutaneously to and from the ascending aorta, expanded by means of said catheter mechanism and, when fully expanded, is in touching contact with the inside walls of said ascending aorta while only partially occluding the aorta, such that said temporary valve provides for the stable transport of valve replacement tools while leaving gaps for continuous blood perfusion.

2. The temporary aortic valve of claim 1 wherein the cross-sectional area of said gaps left by said occluding means when fully expanded represents 35% of the cross-sectional area of the ascending aorta.

3. The temporary aortic valve of claim 1 wherein the cross-sectional area of said gaps left by said occluding means when fully expanded falls within a range of between 0% and 60% of the cross sectional area of the ascending aorta.

4. The temporary aortic valve of claim 1 wherein the cross-sectional area of said gaps left by said occluding means when fully expanded falls within a range of between 25% and 100% of the effective aortic valve area.

5. The temporary aortic valve of claim 1 wherein the cross-sectional area of said gaps left by said occluding means when fully expanded falls within a range of between 25% and 60% of the effective aortic valve area.

6. The temporary aortic valve of claim 1 wherein said the cross-sectional area of the gaps left by said occluding means fully expanded is at least 0.75 cm2 in the case of an adult patient.

7. The temporary aortic valve of claim 1 wherein said valve is positioned within the ascending aorta just above the Sinus of Valsalva and coronary ostia.

8. The temporary aortic valve of claim 1 wherein said expandable means is an inflatable means.

9. The temporary aortic valve of claim 8 wherein said inflatable means comprises a plurality of inflatable balloons.

10. The temporary aortic valve of claim 8 wherein said inflatable means comprises three balloons of equal size and shape.

11. The temporary aortic valve of claim 9 wherein said balloons are of unequal size and shape.

12. (canceled)

13. A method for percutaneous aortic valve replacement comprising the steps of predilating the native aortic valve and ablating the native aortic valve prior to positioning and implanting said percutaneous aortic valve within the aortic annulus.

14. The method of claim 13 wherein said native aortic valve is ablated through deployment of an ablation stent that remains within the aortic annulus and that receives and retains said percutaneous aortic valve.

15. The method of claim 13 further comprising the step of deploying a temporary aortic valve within the ascending aorta above the Sinus of Valsalva and coronary ostia to partially occlude the ascending aorta prior to ablation of the native aortic valve.

16. The method of claim 15 further comprising the step of deploying a temporary aortic valve within the ascending aorta above the Sinus of Valsalva and coronary ostia causing controlled aortic stenosis.

17. The method of claim 15 further comprising the step of deploying a temporary aortic valve within the ascending aorta above the Sinus of Valsalva and coronary ostia causing controlled aortic insufficiency.

18. A method for percutaneous aortic valve replacement comprising the steps of:

a. Percutaneously introducing a guide wire into the ascending aorta and crossing the native aortic valve with said guide wire;

b. Advancing a temporary aortic valve with central catheter mechanism over said guide wire into position inside the ascending aorta;

c. Deploying said temporary aortic valve within the ascending aorta;

d. Advancing a pre-dilation device over said guide wire and within said catheter mechanism into position across said native aortic valve;

e. Deploying said pre-dilation device to dilate said native aortic valve and then withdrawing said device;

f. Advancing an ablation means within said catheter mechanism into position within the aortic annulus;

g. Deploying said ablation means to ablate said native aortic valve against the walls of said aortic annulus;

h. Advancing a replacement aortic valve with deployment means within said catheter mechanism into position within said aortic annulus;

i. Deploying said replacement valve within said aortic annulus using said deployment means; and

j. Withdrawing said deployment means, temporary aortic valve, catheter mechanism and guide wire.

19. The method of claim 18 wherein said temporary aortic valve comprises a reversibly expandable occluding means and a central catheter mechanism, wherein said occluding means in contracted mode can be delivered and withdrawn percutaneously to and from the ascending aorta, expanded by means of said catheter mechanism within said ascending aorta and, when fully expanded, is in touching contact with the inside walls of said ascending aorta while only partially occluding the aorta, leaving gaps for blood perfusion.

20. The method of claim 19 wherein the cross-sectional area of said gaps left by said occluding means when fully expanded represents 35% of the cross-sectional area of the ascending aorta.

21. The method of claim 19 wherein the cross-sectional area of said gaps left by said occluding means when fully expanded falls within a range of between 0% and 60% of the cross sectional area of the ascending aorta.

22. The method of claim 19 wherein the cross-sectional area of said gaps left by said occluding means when fully expanded falls within a range of between 25% and 100% of the effective aortic valve area.

23. The method of claim 19 wherein the cross-sectional area of said gaps left by said occluding means when fully expanded falls within a range of between 25% and 60% of the effective aortic valve area.

24. The method of claim 19 wherein the cross-sectional area of said gaps left by said occluding means when said occluding means is fully expanded is at least 0.75 cm2 in the case of an adult patient.

25. The method of claim 19 wherein said temporary valve is positioned within the ascending aorta just above the Sinus of Valsalva and coronary ostia.

26. The method of claim 19 wherein said occluding means is an inflatable means.

27. The method of claim 19 wherein said inflatable means comprises a plurality of inflatable balloons.

28. The method of claim 27 wherein said inflatable means comprises three balloons of equal size and shape.

29. The method of claim 27 wherein said inflatable means comprises a plurality of balloons of unequal size and shape.

30. The method of claim 19 wherein one or more of the following devices have drug elution capacities:

the catheter means, temporary aortic valve, the pre-dilation device, the ablation means, and the replacement valve deployment means.

33. The method of claim 18 wherein the steps of advancing said pre-dilation device over said guide wire and within a catheter mechanism into position across said native aortic valve and deploying said pre-dilation device to dilate said native aortic valve and then withdrawing said device, are performed prior to the steps of advancing a temporary aortic valve with central catheter mechanism over said guide wire into position inside the ascending aorta and deploying said pre-dilation device to dilate said native aortic valve and then withdrawing said device.

31. A valve ablation stent to prepare the aortic annulus with diseased native aortic valve and valve leaflets to receive a replacement aortic valve in the context of percutaneous aortic valve replacement procedures comprising:

a first end;

a second end;

a central section extending between the first and second ends defining a unitary open cylinder having inner and outer surfaces;

said central section having adequate radial strength to entrap and hold the diseased native aortic valve tightly against the annulus;

wherein said ablation stent functions to ablate said diseased valve leaflets and maintain open a patient'"'"'s aortic annulus.

32. The valve ablation stent of claim 31 wherein said valve ablation stent has drug-elution capacities.