Heart valve sewing cuff

• US 9,314,333 B2
• Filed: 05/24/2012
• Issued: 04/19/2016
• 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, Southard, Fletcher D., Bokros, Jack, Correa, Elva, Poehlmann, Jeffery, Ferre, Josep Gatell
• Primary Examiner(s): SWEET, THOMAS
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US14/118,656
• Publication Number:
  US 20140081391A1
• Time in Patent Office: 1,426 Days
• US Class Current: 1/1
• 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 longitudinal axis, an outlet end, an inlet end, an inner surface, and an outer surface, the outer surface comprising a first sewing cuff located entirely between the inlet and outlet ends; and

at least one leaflet within the tubular valve body to intermittently and reversibly seal across the valve body inner surface to allow substantially unidirectional flow through the tubular valve body from the inlet end to the outlet end;

wherein the first cuff includes a first height that is uniform along an upper edge of the first cuff, a first thickness, a first outermost diameter taken orthogonal to the longitudinal axis;

wherein a total valve height extends from the inlet end to the outlet end;

wherein the outer surface comprises a second sewing cuff located entirely between the inlet and outlet ends;

wherein the second cuff includes a second thickness, a second outermost diameter taken orthogonal to the longitudinal axis, and undulations comprising an apex adjacent a nadir, the second sewing cuff including a second height extending from a top of the apex to a bottom of the nadir;

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

wherein the first thickness at its maximum is less than the second thickness at its maximum;

wherein the first thickness extends radially, in a horizontal plane orthogonal to the longitudinal axis, from an inner wall of the first cuff to an outer wall of the first cuff;

wherein the second thickness extends radially, in a horizontal plane, from an inner wall of the second cuff to an outer wall of the second cuff.

2. The valve of claim 1, wherein the first cuff includes a pliable material configured to accept and retain sutures and the second cuff includes at least one of the pliable material and another pliable material configured to accept and retain sutures.

3. The valve of claim 1, wherein the first and second cuffs include a shared single monolithic portion of porous material.

4. The valve of claim 1, wherein the first outermost diameter is less than the second outermost diameter.

5. The valve of claim 1, wherein the undulations comprise an additional apex adjacent an additional nadir, a first horizontal distance reaches from the apex to the nadir and a second horizontal distance, unequal to the first horizontal distance, reaches from the additional apex to the additional nadir, the undulations being unequally distributed about the second cuff.

6. The valve of claim 1, wherein the apex includes a top and a bottom and a distance between the top and the bottom is less than 0.2 inches and the first height is greater than 0.3 inches.

7. The valve of claim 1, wherein the first and second cuffs are at least one of (a) monolithic with one another, and (b) stitched together and non-monolithic with one another.

8. The valve of claim 1, wherein the apex includes a top and a bottom and a distance between the top and the bottom and the distance is greater than 40% of the first height.

9. The valve of claim 1, wherein the first height is parallel to the longitudinal axis and extends from a topmost location of the first cuff to a bottommost location of the first cuff, the topmost and bottommost locations forming a line parallel to the longitudinal axis.

15. The valve of claim 1, wherein the apex includes the top of the apex and a bottom of the apex and a distance between the top and the bottom is less than 0.2 inches.

16. The valve of claim 8, wherein the distance includes a maximum height between the top and the bottom of the apex and the distance is greater than 40% of the first height.

10. A prosthetic heart valve comprising:

a tubular valve body having a longitudinal axis, an outlet end, an inlet end, an inner surface, and an outer surface, the outer surface comprising first and second sewing cuff portions; and

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

wherein the first cuff portion includes a first height that is uniform along an upper edge of the first cuff, and a first thickness and a first outermost diameter both taken orthogonal to the longitudinal axis;

wherein the second cuff portion includes a second thickness and a second outermost diameter, both orthogonal to the longitudinal axis, and undulations comprising an apex adjacent a nadir, the second sewing cuff portion including a second height extending from a top of the apex to a bottom of the nadir;

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

wherein (a) the first thickness at its maximum is less than the second thickness at its maximum;

(b) the first thickness extends radially, in a horizontal plane orthogonal to the longitudinal axis, from an inner wall of the first cuff to an outer wall of the first cuff; and

(c) the second thickness extends radially, in a horizontal plane, from an inner wall of the second cuff to an outer wall of the second cuff.

11. The valve of claim 10, wherein the first outermost diameter is less than the second outermost diameter.

12. The valve of claim 10, wherein a total valve height extends from the inlet end to the outlet end and the first height is greater than 50% of the total valve height when the valve is closed.

13. The valve of claim 12, wherein the apex includes a top and a bottom and a distance between the top and the bottom and the distance is greater than 40% of the first height.

14. The valve of claim 10, wherein the apex is directly connected to the nadir.

17. The valve of claim 10, wherein the apex includes a top and a bottom and a distance between the top and the bottom and the distance is greater than 40% of the first height.