METHODS OF DELIVERY OF FLEXIBLE HEART VALVES

• US 20140364943A1
• Filed: 08/22/2014
• Published: 12/11/2014
• Est. Priority Date: 09/27/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S.
• Granted Patent: US 9,861,479 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient'"'"'s native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.

Claims

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

radially compressing a prosthetic heart valve to a compressed configuration, wherein the prosthetic heart valve comprises a valve portion formed by a self-expanding leaflet-supporting structure and flexible leaflets supported thereby and a plastically-expandable stent portion connected to and extending from an inflow end of the leaflet-supporting structure, the stent portion being configured to anchor the prosthetic heart valve to a patient'"'"'s native valve annulus;

delivering the compressed prosthetic heart valve to or near a patient'"'"'s native valve annulus;

positioning the leaflet-supporting structure of the prosthetic heart valve on a first side of a patient'"'"'s native valve annulus and the stent portion on a second side opposite the first side; and

expanding the prosthetic heart valve to an expanded configuration, wherein in the compressed configuration at least an inflow portion of the leaflet-supporting structure is positioned within a lumen of the stent portion, and in the expanded configuration the inflow portion of the leaflet-supporting structure is positioned externally to the lumen of the stent portion so as to rest on the first side of the annulus and present an impediment to the valve migrating through the annulus in a first direction, and wherein the stent portion expands into contact with the second side of the annulus and presents an impediment to the valve migrating through the annulus in a second direction opposite the first direction.

2. The method according to claim 1, wherein the prosthetic heart valve includes a one-piece prosthetic heart valve frame.

3. The method according to claim 2, wherein expanding the prosthetic heart valve effectively anchors the prosthetic heart valve without suturing the valve to the native valve.

4. The method according to claim 1, wherein the leaflet-supporting structure of the prosthetic heart valve includes a wireform having alternating arcuate cusps on an inflow end thereof and upstanding commissures projecting toward an outflow end thereof together defining an undulating structure, and wherein the flexible leaflets attach along the undulating structure of the wireform, and wherein in the compressed configuration the inflow portion of the leaflet-supporting structure positioned within the lumen of the stent portion are the cusps of the wireform, and in the expanded configuration the cusps of the wireform are positioned externally to the lumen of the stent portion.

5. The method according to claim 1, wherein the leaflet-supporting structure of the prosthetic heart valve includes a cloth covered wireform to which a cloth covered flexible stent and outer sealing ring subassembly is coupled, the sealing ring being also positioned on the first side of the annulus when the valve is expanded and presents an impediment to the valve migrating through the annulus in a first direction.

6. The method according to claim 1, wherein the stent portion comprises a number of vertical struts connected by a plurality of circumferentially-extending and radially expandable struts including a first circumferential strut closest to the inflow end of the leaflet-supporting structure, and the stent portion connects to the an inflow end of the leaflet-supporting structure via connecting sutures threaded around the circumferential strut.

7. The method according to claim 6, wherein the first circumferential strut comprises a plurality of circular openings through which the connecting sutures thread and segments between the circular openings that are pinched into V-shaped sections in the compressed configuration of the stent portion and which straighten out in the expanded configuration.

8. The method according to claim 1, wherein the stent portion comprises a number of vertical struts connected by a plurality of circumferentially-extending and radially expandable struts, and wherein different rows of circumferentially-extending struts are configured to expand different amounts so that the stent portion flares outwards toward its inflow end when expanded.

9. The method according to claim 1, wherein the leaflet-supporting structure of the prosthetic heart valve includes a wireform formed of a superelastic material chosen from the group consisting of Nitinol, NiTiCo, NiTiCr, and alloys thereof, and the stent portion of the prosthetic heart valve is formed of a plastically deformable material chosen from the group consisting of stainless steel, cobalt, chromium, titanium, and alloys thereof.

10. The method according to claim 1, wherein the stent portion has sufficient rigidity to maintain the inflow end of the leaflet-supporting structure in its compressed configuration while an outflow end of the leaflet-supporting structure is held in a compressed configuration by an external restraint and the step of expanding the prosthetic heart valve to an expanded configuration includes removing the external restraint.

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

radially compressing a prosthetic heart valve to a compressed configuration, wherein the prosthetic heart valve comprises a plastically-deformable stent portion on an inflow end configured to anchor the prosthetic heart valve to a patient'"'"'s native valve annulus and a self-expanding leaflet-supporting structure on an outflow end and flexible leaflets supported thereby, the stent portion and leaflet-supporting structure being connected in series and the stent portion having sufficient rigidity to maintain the inflow end of the leaflet-supporting structure in its compressed configuration while an outflow end of the leaflet-supporting structure is held in a compressed configuration by an external restraint;

delivering the compressed prosthetic heart valve to a patient'"'"'s native valve annulus;

positioning the leaflet-supporting structure of the prosthetic heart valve on a first side of a patient'"'"'s native valve annulus and the stent portion on a second side opposite the first side;

plastically expanding the stent portion outward into contact with surrounding anatomical structure; and

removing the external restraint to permit the outflow end of the leaflet-supporting structure to self-expand outward into contact with surrounding anatomical structure.

12. The method according to claim 11, wherein the leaflet-supporting structure includes a wireform having alternating arcuate cusps on an inflow end thereof and upstanding commissures projecting toward an outflow end thereof together defining an undulating structure, and wherein the flexible leaflets attach along the undulating structure of the wireform, and wherein when compressed the cusps of the wireform are positioned within the lumen of the stent portion, and when expanded the cusps of the wireform are positioned externally to the lumen of the stent portion.

13. The method according to claim 11, wherein the leaflet-supporting structure includes a wireform formed of a superelastic material that is shape set to an expanded configuration, and radially crimped and held in a compressed configuration by the external restraint for delivery, and the external restraint is selected from the group consisting of a sheath, a valve holder, and at least one suture.

14. The method according to claim 11, wherein the leaflet-supporting structure includes a wireform having alternating arcuate cusps on an inflow end thereof and upstanding commissures projecting toward an outflow end thereof together defining an undulating structure, and the external restraint is at least one suture threaded through the commissure supports and tensioned to hold them in the compressed configuration.

15. The method according to claim 11, wherein the step of delivering the compressed prosthetic heart valve to a patient'"'"'s native valve annulus includes delivering the compressed prosthetic heart valve through a thoracotomy and a small aortotomy.

16. The method according to claim 11, wherein the leaflet-supporting structure of the prosthetic heart valve includes a cloth covered wireform to which a cloth covered flexible stent and outer sealing ring subassembly is coupled.

17. The method according to claim 11, wherein the stent portion comprises a number of vertical struts connected by a plurality of circumferentially-extending and radially expandable struts including a first circumferential strut closest to the inflow end of the leaflet-supporting structure, and the stent portion connects to the an inflow end of the leaflet-supporting structure via connecting sutures threaded around the circumferential strut.

18. The method according to claim 17, wherein the first circumferential strut comprises a plurality of circular openings through which the connecting sutures thread and segments between the circular openings that are pinched into V-shaped sections in the compressed configuration of the stent portion and which straighten out in the expanded configuration.

19. The method according to claim 11, wherein the stent portion comprises a number of vertical struts connected by a plurality of circumferentially-extending and radially expandable struts, and wherein different rows of circumferentially-extending struts are configured to expand different amounts so that the stent portion flares outwards toward its inflow end when expanded.

20. The method according to claim 11, wherein the leaflet-supporting structure of the prosthetic heart valve includes a wireform formed of a superelastic material chosen from the group consisting of Nitinol, NiTiCo, NiTiCr, and alloys thereof, and the stent portion of the prosthetic heart valve is formed of a plastically deformable material chosen from the group consisting of stainless steel, cobalt, chromium, titanium, and alloys thereof.