Encapsulated heart valve

• US 8,945,209 B2
• Filed: 05/18/2012
• Issued: 02/03/2015
• Est. Priority Date: 05/20/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bonyuet, Celeste C., Walls, Andrew L., Migliazza, John F., Pelled, Itai
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US13/475,210
• Publication Number:
  US 20120296418A1
• Time in Patent Office: 991 Days
• Field of Search: 623/2.18, 623/2.1, 623/2.14
• 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 comprising a tubular frame that is radially collapsible to a collapsed state for introduction into the body on a delivery catheter and radially expandable to an expanded state for implanting the valve at a desired location in the body, the frame having an inflow end and an outflow end, and the frame having a plurality of connected axial and circumferential struts defining a plurality of discrete cells within each of which is formed an opening;

a fabric layer including a fabric skirt positioned adjacent the frame and configured to prevent blood from flowing through the openings in the frame that are covered by the skirt;

a non-absorbable encapsulating material that encapsulates 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, wherein portions of the encapsulating material lie on opposite sides of the fabric layer and are fused together from heating, wherein the encapsulating material comprises a first tubular layer positioned on the inside of the tubular 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 completely covering the fabric layer, the second tubular layer and the first tubular layer defining the portions of the encapsulating material that are fused together to form a covering that encapsulates the fabric layer and the frame, and wherein the skirt is attached to the frame by the covering and without sutures; and

a valvular structure mounted to the valve component within the tubular frame and configured to permit blood flow in a first direction through the valve and block blood flow in a second direction, opposite the first direction.

2. The prosthetic valve of claim 1, wherein the first and second tubular layers comprise ePTFE or UHMWPE.

3. The prosthetic valve of claim 1, wherein the valvular structure comprises one or more leaflets sutured to the frame and the skirt.

4. The prosthetic valve of claim 1, wherein the first and second tubular layers completely cover the frame.

5. The prosthetic valve of claim 1, wherein the first and second tubular layers only partially cover the frame.

6. The prosthetic valve of claim 5, wherein the fabric skirt has a lower edge adjacent the inflow end of the frame and an upper edge spaced from the outflow edge of the frame, and the first and second tubular layers completely cover the portion of the frame adjacent the fabric skirt but the struts of the frame that extend above the upper edge of the skirt are not covered.

7. An implantable prosthetic valve comprising:

a metallic wireform assembly formed of an elongated member that defines a flow orifice and is covered by a fabric;

encapsulating material encapsulating the wireform assembly and its fabric covering and being fused together from heating to secure the fabric covering around the wireform without sutures;

a stent that is covered by a fabric, the stent having convex cusp portions extending between upstanding commissure portions that follow the shape of the wireform assembly;

encapsulating material encapsulating the stent and its fabric covering and being fused together from heating to secure the fabric covering around the stent without sutures;

wherein the wireform assembly and stent are assembled together to form a support structure, and

valve leaflets secured with respect to the support structure and spanning the flow orifice to provide one-way fluid occluding surfaces through the orifice.

8. The prosthetic valve of claim 7, wherein the encapsulating material comprises ePTFE or UHMWPE.

9. The prosthetic valve of claim 7, further including:

an annular sewing ring having a cloth cover; and

encapsulating material encapsulating the sewing ring and its fabric covering and being fused together from heating to secure the fabric covering around the sewing ring without sutures,

wherein the sewing ring is assembled with the support structure with the sewing ring surrounding an inflow end thereof.

10. An implantable prosthetic valve comprising:

a radially collapsible and expandable tubular frame, the frame having an inflow end and outflow end and a length therebetween, the frame comprising a plurality of connected struts defining a plurality of discrete cells within each of which is formed an opening;

an annular fabric skirt positioned only on the outside of the frame, the skirt having a length less than the length of the frame;

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

an outer tubular layer positioned on the outside of the skirt and being fused to the inner tubular layer at selected areas from heating, the inner and outer tubular layers forming a covering that at least partially encapsulates the frame and skirt, and wherein the covering completely covers the fabric skirt and that portion of the frame adjacent the fabric skirt; and

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

11. The prosthetic valve of claim 10, wherein the inner and outer tubular layers comprise ePTFE or UHMWPE.

12. The prosthetic valve of claim 10, 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.

13. The prosthetic valve of claim 10, wherein the covering completely covers the frame.

14. The prosthetic valve of claim 10, 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.