Heart valve prosthesis with rotatable cuff

• US 6,358,278 B1
• Filed: 09/24/1999
• Issued: 03/19/2002
• Est. Priority Date: 09/24/1999
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Kramlinger, William R., Runquist, Jonas A., Girard, Michael J., Brendzel, Avrom M.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/406,275
• Time in Patent Office: 907 Days
• Field of Search: 623/2.41, 623/2.4, 623/2.38, 623/2.39
• US Class Current: 623/2.39
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442

Abstract

A prosthetic heart valve includes an orifice ring adapted to carry blood therethrough. An annular recess is formed in an outer surface of the orifice ring and has first and second axially spaced walls. A sewing cuff is adapted to be coupled to a native tissue annulus of a heart and includes an inner annular cuff portion adapted to conform to the first and second recess walls in the orifice ring. A cuff retaining ring extends around the inner annular fabric portion such that the inner annular cuff portion is positioned between the cuff retaining ring and the annular recess. The cuff retaining ring is further adapted to exert a substantially axially directed force directed against the annular cuff portion and first and second axially spaced walls of the annular recess, which is substantially greater than a radial force directed substantially inwardly by the cuff retaining ring against an annulus of the recess located between the first and second walls, whereby a controllable torque to rotate the cuff relative to the orifice ring is developed substantially due to friction between the first and second recess walls cuff portion and the annular recess.

Claims

1. A prosthetic heart valve, comprising:

a valve body consisting of an orifice ring and an occluder;

the orifice ring adapted to carry blood therethrough when an occluder is in its open position;

an annular recess formed in an outer surface of the orifice ring which defines first and second axially spaced walls in the outer surface of the orifice ring;

a compressible sewing cuff adapted to be coupled to a native tissue annulus of a heart, the cuff including an inner annular cuff portion adapted to conform to the first and second recess walls in the orifice ring; and

a stiff cuff retaining ring adapted to extend around the inner annular cuff portion such that the inner annular cuff portion is positioned between the cuff retaining ring and the annular recess, the cuff retaining ring further adapted to exert a substantially axial force directed in an axial direction through the cuff and against the first and second axially spaced walls of the annular recess, said axial force being substantially greater than a radial force directed substantially inwardly by the cuff retaining ring against an annulus of the recess located between the first and second walls, whereby a controllable torque to rotate the sewing cuff relative to the valve body is developed substantially due to friction between the first and second recess walls and the inner annular cuff portion.

2. The prosthetic heart valve of claim 1 wherein the sewing cuff retaining ring comprises a biocompatible high-strength metal.

3. The prosthetic heart valve of claim 2 wherein the metal of the cuff retaining ring consists of an alloy of cobalt.

4. The prosthetic heart valve of claim 3 wherein the ring provides radiopacity to the heart valve.

5. The prosthetic heart valve of claim 2 wherein the metal of the cuff retaining ring includes titanium and alloys thereof.

6. The prosthetic heart valve of claim 1 wherein the sewing cuff comprises a biocompatible, pliable and compressible fabric structure.

7. The prosthetic heart valve of claim 1 wherein the sewing cuff comprises fabric and the cuff retaining ring is carried within the cuff.

8. The prosthetic heart valve of claim 1 wherein the sewing cuff is adapted to receive a suture therethrough to affix the cuff to the tissue annulus.

9. The prosthetic heart valve of claim 1 wherein an outer diameter of the cuff retention ring does not exceed a maximum outer diameter of the valve body.

10. The prosthetic heart valve of claim 1 wherein the torque required to rotate the cuff relative to the orifice ring is between about 1 and about 15 oz-inches.

11. The prosthetic heart valve of claim 1 including first and second rims in the orifice ring to provide the first and second axially spaced walls and define the annular recess therebetween.

12. The prosthetic heart valve of claim 1 wherein an axial distance(s) between the first and second axially spaced walls minus an axial length (L) of the cuff retaining ring is less than or equal to a height (H) of the recess minus a width (W) of the cuff retaining ring.

13. The prosthetic heart valve of claim 1 wherein the prosthetic heart valve provides a relatively low profile.

14. A method of manufacturing a heart valve prosthesis, comprising:

folding a tube of biocompatible, pliable, compressible material over a stiff cuff retaining ring;

positioning a portion of the cuff retaining ring and tube material in an annular recess of an orifice ring, the annular recess formed between first and second axially spaced walls;

positioning a remainder of the cuff retaining ring into the annular recess, wherein the cuff retaining ring substantially compresses the material against the first and second axially spaced walls and substantially does not compress the tube material radially against the annulus of the recess such that an axial force against the first and second walls of the recess is substantially greater than a radial force directed substantially inwardly by the cuff retaining ring against an annulus of the recess located between the first and second walls; and

affixing the tube material to itself to form a sewing cuff.

15. The method of claim 14 wherein the tube material is affixed to itself using sutures to form a sewing cuff.

16. The method of claim 14 wherein a portion of the tube of biocompatible, pliable, compressible material is reduced in thickness prior to assembly.

17. The method of claim 14 wherein an axial distance(s) between the first and second axially spaced walls minus an axial length (L) of the cuff retaining ring is less than or equal to a height (H) of the recess minus a width (W) of the cuff retaining ring.