MINIMALLY-INVASIVE HEART VALVE WITH CUSP POSITIONERS

• US 20080269878A1
• Filed: 07/09/2008
• Published: 10/30/2008
• Est. Priority Date: 03/18/2003
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Iobbi, Mario M.
• Granted Patent: US 8,778,018 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures. In the aortic valve position, the cusp positioners angle outward into contact with the sinus cavities, and compress the native leaflets if they are not excised, or the aortic wall if they are. The support frame may be formed from a flat sheet of Nitinol that is bent into a three-dimensional configuration and heat set. A holder having spring-like arms connected to inflow projections of the valve may be used to deliver, reposition and re-collapse the valve, if necessary.

Claims

1. A method of implanting a prosthetic aortic heart valve, comprising:

providing a collapsible prosthetic heart valve having a collapsible leaflet frame defined by three cusp regions on an inflow end of the valve intermediate three commissure regions on an outflow end of the valve, the valve further including three cusp positioners on the outflow end and intermediate the three commissure regions;

collapsing the prosthetic heart valve within a delivery tube;

advancing the prosthetic heart valve within the delivery tube to an aortic annulus;

expelling the prosthetic heart valve from the delivery tube by relative movement therebetween;

expanding the prosthetic heart valve; and

positioning the prosthetic heart valve such that the cusp positioners contact the two coronary and one non-coronary sinuses of the ascending aorta without blocking the coronary ostia.

2. The method of claim 1, further including:

connecting a holder having flexible members to the commissure regions of the prosthetic heart valve and utilizing the flexible members to perform the step of positioning the prosthetic heart valve.

3. The method of claim 2, further including:

connecting flexible members of the holder to the cusp positioners and utilizing the flexible members to perform the step of positioning the prosthetic heart valve.

4. The method of claim 2, further including utilizing the flexible members to rotate the prosthetic heart valve during the step of positioning.

5. The method of claim 2, further including utilizing the flexible members to re-collapse the prosthetic heart valve after the step of expanding.

6. The method of claim 1, wherein the prosthetic heart valve is expanded in a location that is inferior to a final implant position such that the cusp positioners contact the surrounding aortic annulus, and the step of positioning comprises displacing the valve in a superior direction to a final implant position.

7. The method of claim 6, wherein the cusp positioners are flared outward to define a circle about a flow axis of the valve greater than a circle about the flow axis defined by the three commissure regions, and wherein the step of displacing the valve in a superior direction causes the outwardly flared cusp positioners to be channeled into perspective coronary sinuses.

8. The method of claim 1, wherein the collapsible leaflet frame is formed of a shape memory alloy having an austenitic transition temperature less than body temperature, and wherein the step of collapsing is done with the material of the leaflet frame at a temperature at or below its martensitic transition temperature.

9. The method of claim 8, wherein the step of collapsing is done in conjunction with immersing the prosthetic heart valve in an ice bath to reduce the temperature of the material of leaflet frame to less than or equal to its martensitic transition temperature.

10. The method of claim 1, wherein the collapsible leaflet frame is formed of a shape memory alloy having a memory condition in its expanded state, and wherein the step of expanding the prosthetic heart valve comprises both permitting self-expansion of the valve to an intermediate diameter and then using a physical expander to increase the diameter of the valve to the memory condition of the leaflet frame.

11. A method of implanting a collapsible prosthetic heart valve, comprising:

providing a self-expanding valve comprised of a material displaying hysteresis in the elastic or superelastic region;

permitting the valve to self-expand to a first diameter; and

assisting the valve with a physical expander to further expand to a second diameter.

12. The method of claim 11, wherein the prosthetic heart valve includes a collapsible leaflet frame formed of a shape memory alloy having an austenitic transition temperature less than body temperature, and further including a step of collapsing the valve with the material of the leaflet frame at a temperature at or below its martensitic transition temperature.

13. The method of claim 12, wherein the step of collapsing is done in conjunction with immersing the prosthetic heart valve in an ice bath to reduce the temperature of the material of leaflet frame to less than or equal to its martensitic transition temperature.

14. The method of claim 11, wherein the physical expander is a balloon.

15. The method of claim 11, wherein the prosthetic heart valve has a collapsible leaflet frame defined by three cusp regions on an inflow end of the valve intermediate three commissure regions on an outflow end of the valve, the valve further including three cusp positioners on the outflow end and intermediate the three commissure regions, the method further including:

collapsing the prosthetic heart valve within a delivery tube;

advancing the prosthetic heart valve within the delivery tube to an aortic annulus;

expelling the prosthetic heart valve from the delivery tube by relative movement therebetween;

expanding the prosthetic heart valve by the steps of permitting self-expansion and assisting further expansion; and

positioning the prosthetic heart valve such that the cusp positioners contact the two coronary and one non-coronary sinuses of the ascending aorta without blocking the coronary ostia.

16. The method of claim 15, further including:

connecting a holder having flexible members to the commissure regions of the prosthetic heart valve and utilizing the flexible members to perform the step of positioning the prosthetic heart valve.

17. The method of claim 16, further including:

connecting flexible members of the holder to the cusp positioners and utilizing the flexible members to perform the step of positioning the prosthetic heart valve.

18. The method of claim 16, further including utilizing the flexible members to rotate the prosthetic heart valve during the step of positioning.

19. The method of claim 16, further including utilizing the flexible members to re-collapse the prosthetic heart valve after the step of expanding.