ENCAPSULATED HEART VALVE

• US 20120296418A1
• Filed: 05/18/2012
• Published: 11/22/2012
• Est. Priority Date: 05/20/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Migliazza, John F., Pelled, Itai, Bonyuet, Celeste, Walls, Andrew
• Granted Patent: US 8,945,209 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The present disclosure concerns embodiments of implantable prosthetic devices, and in particular, implantable prosthetic valves, and methods for making such devices. In one aspect, a prosthetic device includes encapsulating layers that extend over a fabric layer and secure the fabric layer to another component of the device. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves. In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve.

Claims

1. An implantable prosthetic valve comprising:

a valve component;

a fabric layer disposed adjacent the valve component; and

a non-absorbable encapsulating material at least partially encapsulating the fabric layer and the valve component so as to secure the fabric layer to the valve component, the encapsulating material having a porous microstructure that promotes ingrowth of surrounding tissue to assist in securing the prosthetic valve in a body lumen.

2. The prosthetic valve of claim 1, wherein:

the valve component comprises an annular frame;

the encapsulating material comprises a first tubular layer positioned on the inside of the frame and the fabric layer and a second tubular layer positioned on the outside of the frame and the fabric layer, the second tubular layer and the first tubular layer having respective portions at least partially covering the fabric layer and the frame, the second tubular layer and the first tubular layer further having respective portions that are bonded to each other to form a covering that at least partially encapsulates the fabric layer and the frame.

3. The prosthetic valve of claim 2, wherein the first and second tubular layers comprise ePTFE or UHMWPE.

4. The prosthetic valve of claim 2, wherein:

the frame comprises a radially collapsible and expandable annular frame, the frame having an inlet end and outlet end, the frame comprising a plurality of frame members defining a plurality of gaps between the frame members; and

the fabric layer comprises an annular fabric skirt positioned adjacent the frame and configured to prevent blood from flowing through gaps in the frame that are covered by the skirt.

5. The prosthetic valve of claim 4, further comprising a valvular structure mounted to the frame and configured to permit blood flow in a first direction through the device and block blood flow through the device in a second direction, opposite the first direction.

6. The prosthetic valve of claim 5, wherein the valvular structure comprises one or more leaflets sutured to the frame and the skirt.

7. The prosthetic valve of claim 1, wherein the valve component comprises a wireform, a sewing ring, or a stent.

8. An implantable prosthetic valve comprising:

a radially collapsible and expandable annular frame, the frame having an inlet end and outlet end, the frame comprising a plurality of frame members defining a plurality of gaps between the frame members;

an annular fabric skirt positioned adjacent the frame and configured to prevent blood from flowing through gaps in the frame that are covered by the skirt;

an inner tubular layer positioned on the inside of the frame and the skirt;

an outer tubular layer positioned on the outside of the frame and the skirt and being bonded to each other at selected areas, the inner and outer tubular layers forming a covering that at least partially encapsulates the frame and skirt; and

one or more flexible valve leaflets sutured to the frame and the skirt.

9. The prosthetic valve of claim 8, wherein the inner and outer tubular layers comprise ePTFE or UHMWPE.

10. The prosthetic valve of claim 8, wherein the skirt is secured to the frame by the covering formed by the inner and outer tubular layers and does not include any sutures to secure the skirt to the frame.

11. The prosthetic valve of claim 8, wherein the skirt is completely encapsulated by the covering formed by the inner and outer tubular layers.

12. The prosthetic valve of claim 8, wherein the skirt is disposed on the outside of the frame.

13. The prosthetic valve of claim 8, wherein the inner and outer tubular layers are formed with gaps that correspond to gaps in the frame that are not covered by the skirt.

14. The prosthetic valve of claim 8, wherein an inflow end of the skirt is aligned with an inflow end of the frame and a portion of the frame between an outflow end of the skirt and an outflow end of the frame is not covered by the inner and outer tubular layers.

15. A method for making an implantable prosthetic device, comprising:

placing a first tubular covering member on a support;

placing a sub assembly of the prosthetic device over the first covering member, the sub assembly comprising an annular component and a fabric layer at least partially covering the annular component;

placing a second tubular covering member over the sub assembly;

applying pressure to force the second covering member and the first covering member into contact with other;

heating the first and second covering member to form a monolithic covering that at least partially encapsulates the sub assembly and thereby secures the fabric layer to the annular component.

16. The method of claim 15, further comprising suturing a valvular structure to the monolithic covering and the sub assembly.

17. The method of claim 15, wherein the annular component comprises an annular frame and the fabric layer comprises an annular skirt disposed on the inside or outside of the frame.

18. The method of claim 15, wherein the annular component comprises a wireform having a plurality of commissure portions and cusp portions extending between adjacent commissure portions.

19. The method of claim 15, wherein the annular component comprises a stent having a plurality of commissure portions and cusp portions extending between adjacent commissure portions.

20. The method of claim 15, wherein the annular component comprises a sewing ring.