Heart valve sewing cuff

• US 9,788,947 B2
• Filed: 04/18/2016
• Issued: 10/17/2017
• Est. Priority Date: 05/26/2011
• Status: Active Grant

• Current Assignee: On-X Life Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: On-X Life Technologies, Inc. (Cryolife Incorporated)
• Inventors: Ruyra-Baliarda, Francisco Javier, Ferre, Josep Gatell, Southard, Fletcher D., Bokros, Jack, Correa, Elva, Poehlmann, Jeffery
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US15/131,371
• Publication Number:
  US 20160270915A1
• Time in Patent Office: 547 Days
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular

Abstract

An embodiment of the invention includes a sewing cuff for aortic heart valves that better approximates native anatomy by better mating with the crown-like anatomical annulus. Limiting distortion of the crown-like annulus provides better blood flow and overall valve function and provides a physician greater ease of implantation since native anatomy is not flattened. Thus, the surgeon may attach sutures to the fibrous tissue of the crown-like anatomical annulus without distorting the shape of the native anatomy. An embodiment includes a scalloped sewing cuff assembly (with semilunar arches) that tracks the crown-like annulus. Another embodiment provides a sewing cuff positioned over the majority of the valve'"'"'s length, thus allowing the surgeon greater flexibility as to where he or she can attach sutures to the surgical annulus. Conventional valves, which are primarily “low-profile” devices, do not offer such ability. Other embodiments are described herein.

Claims

1. A prosthetic heart valve comprising:

a tubular valve body having a vertical axis, an outlet end, and an inlet end;

a sewing cuff located entirely between the inlet and outlet ends; and

at least one leaflet to intermittently allow flow through the tubular valve body from the inlet end to the outlet end;

wherein the sewing cuff includes a first portion comprising;

(a)(i) first height that is uniform along an upper edge of the first portion, and (a)(ii) a first outermost diameter taken orthogonal to the vertical axis;

wherein the sewing cuff includes a second portion comprising;

(b)(i) undulations that each comprise an apex adjacent a nadir, (b)(ii) a second height extending from a top of the apex to a bottom of the nadir, and (b)(iii) a second outermost diameter taken orthogonal to the vertical axis;

wherein both of the first and second portions include polytetrafluoroethylene (PTFE) fabric;

wherein the second height is at least 75% of the first height;

wherein the second outermost diameter is greater than the first outermost diameter;

wherein the tubular valve body includes a projection that extends horizontally away from the vertical axis;

wherein a subportion of the first portion is above the projection and an additional subportion of the first portion is below the projection; and

wherein the projection, subportion, and additional subportion are oriented in relation to each other such that the projection resists the subportion and additional subportion from sliding off the tubular valve body.

2. The valve of claim 1, wherein the first portion includes a cylindrical portion.

3. The valve of claim 2, wherein the cylindrical portion includes a circular perimeter that defines the first outermost diameter.

4. The valve of claim 1, wherein the first and second portions share a single, monolithic portion of the PTFE fabric.

5. The valve of claim 1, wherein the apex is directly connected to the nadir.

6. The valve of claim 1, wherein the first and second portions are both configured to accept and retain sutures.

7. The valve of claim 1, wherein the first and second portions are non-monolithic with one another.

8. The valve of claim 1, wherein:

the second portion does not extend above the first portion;

the second portion does not extend below the first portion.

9. The valve of claim 1, wherein:

the first and second portions share a single, monolithic portion of the PTFE fabric;

a radial axis, radiating horizontally outward from and orthogonal to the vertical axis, intercepts the monolithic portion of the PTFE fabric at least 3times; and

the horizontal axis intercepts the projection.

10. The valve of claim 9, wherein an additional vertical axis intercepts the monolithic portion of the PTFE fabric at least 3times.

11. The valve of claim 1, wherein the prosthetic heart valve is not a bioprosthetic.