Modular heart valve prothesis

• US 6,217,611 B1
• Filed: 05/26/1999
• Issued: 04/17/2001
• Est. Priority Date: 05/26/1999
• Status: Expired due to Term

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sulzer Carbomedics Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Klostermeyer, Tammi E.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US09/320,023
• Time in Patent Office: 692 Days
• Field of Search: 623/2.1, 623/2.17, 623/2--, 623/2.37, 623/2.38, 623/2.39, 623/2.41
• US Class Current: 623/2.38
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03

Abstract

A heart valve prosthesis including a valve body having a first retainer integrally formed with an outer surface thereof. A grafting assembly is formed to include a stiffening member having an axial bore extending therethrough and a second retainer integral with a surface of the stiffening member. The valve body is mounted within the bore of the stiffening member. A retaining member engages the first and second retainers to limit axial displacement of the stiffening member relative to the valve assembly.

Claims

1. A modular heart valve prosthesis, comprising:

an independently implantable graft assembly module including

a stiffening member having an axial bore extending therethrough, and having an inner surface and an outer surface a grafting member secured to said stiffening member at the outer surface thereof, and

a retaining member resiliently engaging said outer surface of the stiffening member, at least a first part of said retaining member extending through said stiffening member and

a valve module insertable in said graft assembly module after implantation of said graft assembly module, said valve module including a valve body having a first groove extending at least partially around an outer surface of the valve body, said valve module being selectively secured in said graft assembly module by said first part of said retaining member engaging said first groove.

2. The heart valve prosthesis of claim 1 wherein the retention member engages the first groove of the valve body in response to the valve body being inserted into the bore of the stiffening member.

3. The heart valve prosthesis of claim 1 wherein a second groove is formed in said outer surface of the stiffening member, the retaining member engaging the second groove.

4. The heart valve prosthesis of claim 1 further comprising at least one window formed in the stiffening member, each window extending between said outer surface and the bore of the stiffening member, a portion of the retention member extending through the window.

5. The heart valve prosthesis of claim 4 wherein the retaining member is an elongated resilient clip having first and second retention portions, the first and second portions extending through a respective window in the stiffening member.

6. The heart valve prosthesis of claim 1 wherein the valve body includes a tapered portion adjacent an edge of said outer surface of the valve body.

7. The heart valve prosthesis of claim 1 wherein the retaining member is a resiliently deformable clip.

8. The heart valve prosthesis of claim 1 wherein the grafting member is a fabric sewing cuff.

9. The heart valve prosthesis of claim 1 further comprising a plurality of leaflets pivotally mounting to an inside surface of the valve body.

10. The heart valve prosthesis of claim 1 wherein the stiffening member has an annular cross section.

11. The heart valve prosthesis of claim 1 said retaining member has two ends, both ends extending through said stiffening member and said retaining member further comprising means for fixedly securing said two ends of the retention member in a selected position relative to said two ends.

12. The heart valve prosthesis of claim 11 wherein the means for securing is a clip.

19. The heart valve prosthesis of claim 5 wherein said clip comprises a wire contoured to lie generally along said outer surface of said stiffening member and wherein said first and second portions comprise radially inwardly extending arcs.

20. The heart valve prosthesis of claim 1 wherein at least an end of said retaining member extends through said stiffening member.

13. A method of implanting a heart valve, comprising the steps of:

forming a valve body having a first groove extending at least partially around an outer surface of the valve body;

forming a graft assembly including a stiffening member having an axial bore extending therethrough for receiving the valve body and also including a second groove in a surface thereof;

a grafting member secured to an outer surface of said stiffening member, and a retaining member in the second groove of the stiffening member,

implanting said graft assembly in the cardiovascular system of a patient,

inserting said valve body into said axial bore of said stiffening member of the implanted graft assembly, until said retaining member engages the first groove of the valve body to limit axial displacement of the valve body relative to the stiffening member.

14. The method of claim 13 wherein the step of forming a graft assembly includes the step of forming at least one window in the stiffening member extending between the outer surface and the bore of the stiffening member and wherein said second groove is on said outer surface of said stiffening member and only a portion of said retaining member extends through said windows in said stiffening ring.

15. The method of claim 13 wherein the step of forming a valve body includes the step of forming a tapered portion adjacent an edge of said outer surface of the valve body and wherein said step of inserting said valve body into said stiffening ring includes forcing said retaining means outwardly with said tapered portion.

16. The method of claim 14 wherein said stiffening member has at least two windows and a portion of the retaining member extends through each of said windows and wherein the step of engaging the resilient member to limit axial displacement includes the step of engaging first and second retention portions of the retention member in the first groove of the valve body.

17. The method of claim 13 wherein said retaining member comprises a first and a second end, said ends extending through said grafting member and wherein said step of inserting said valve body further includes securing said ends in a selected position relative to each other.

18. The method of claim 17 wherein said step of securing said ends includes clipping said ends together.