Sutureless heart valve prosthesis

• US 6,287,339 B1
• Filed: 05/27/1999
• Issued: 09/11/2001
• Est. Priority Date: 05/27/1999
• Status: Expired due to Term

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sulzer Carbomedics Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Vazquez, Demetrio J., Campbell, Louis A., Mabrey, Jeffrey M.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): STEWART, ALVIN J
• Application Number:
  US09/321,079
• Time in Patent Office: 838 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.14, 623/2.18, 623/2.23, 623/2.36, 623/2.38, 623/2.4, 623/2.41, 623/2.42
• US Class Current: 623/2.4
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A heart valve prosthesis which incorporates a substantially permanently implantable abutment structure which is surgically attached to a native heart valve annulus through utilization of a resilient metal substructure having an attachment portion which moves into engagement with a native heart annulus upon being released from a retracted orientation. The system employs a positioning instrument which locates the abutment structure and associated heart valve prosthesis at the proper location for releasing the attachment components. Mechanical heart valve components including an occluder function are removably attached to the abutment structure using sutures, such that the valve function itself may be subsequently replaced.

Claims

1. A heart valve prosthesis for implantation at a heart valve annulus location having an aortic valve-mitral valve annulus region of mutual adjacency, comprising:

A) a substantially permanently implantable abutment structure comprising a resilient metal substructure extending about a centrally disposed valve channel opening and having

1) an attachment portion extending outwardly from said opening to define a first region having a widthwise first radial dimension selected for effecting resiliently biased engagement with said heart valve annulus at locations without said region of mutual adjacency;

2) a second region having a widthwise second radial dimension less than said first radial dimension for engagement with said heart valve annulus within said region of mutual adjacency, said second widthwise dimension being effective to avoid substantial interference between the aortic and mitral valve functions; and

3) a tissue ingrowth promoting porous layer located over substantially all surfaces of said substructure; and

B) a heart valve comprising a support ring with an interior valve channel supporting a blood flow control occluder and having an outwardly disposed annular sewing cuff removably coupled with said abutment structure in a manner axially aligning said support ring with said centrally disposed valve channel opening.

2. The heart valve prosthesis of claim 1 in which said heart valve sewing cuff is attached to said abutment structure with sutures.

3. The heart valve prosthesis of claim 1 in which said porous layer is a tissue ingrowth promoting cloth.

4. The heart valve prosthesis of claim 3 in which said cloth is provided as an integral component of said annular sewing cuff to effect said removable coupling.

5. The heart valve prosthesis of claim 1 in which said attachment portion comprises an elastic metal engagement component biased for movement outwardly into tissue at the ventricular side of said heart valve annulus.

6. The heart valve prosthesis of claim 1 in which said attachment portion comprises an engagement component comprising a shape memory metal having a memory orientation for engaging tissue at the ventricular side of said heart valve annulus.

7. The heart valve prosthesis of claim 1 wherein:

1) said metal substructure comprises an outwardly open, generally torus-shaped structure;

2) said attachment portion comprises a first engagement portion for engagement with the aortic side of said heart valve annulus and a second engagement portion for engagement with the ventricular side of said heart valve annulus; and

3) said heart valve support ring is coupled to said valve channel opening.

8. The heart valve prosthesis of claim 7 wherein at least one of said first and said second engagement portions comprises an elastic metal component biased for movement from a valve axial orientation outwardly toward said heart valve annulus.

9. The heart valve prosthesis of claim 7 wherein at least one of said first and said second engagement portions comprises a shape memory metal having a memory orientation biasing it for movement from a valve axial orientation outwardly toward said heart valve annulus.

10. The heart valve prosthesis of claim 1 wherein said second region is generally structured having an outer periphery configured as a chord of a circle defined by said first radial dimension.

11. The heart valve prosthesis of claim 1 wherein:

A) said heart valve support ring comprises a diameter;

B) said substructure comprises an annulus having an outer circular periphery corresponding to the diameter of the support ring;

C) said attachment portion comprises three tissue engaging tabs extending outwardly from said circular periphery and three tissue engaging resiliently outwardly biased dogs;

D) said sewing cuff comprises a flange extending outwardly from said heart valve support ring, said sewing cuff being removably coupled to said substructure annulus.

12. The heart valve prosthesis of claim 11 in which said substructure attachment portion tabs extend radially outwardly from said annulus outer periphery a distance effective to resist blood backflow pressure.

13. The heart valve prosthesis of claim 11 in which said substructure attachment portion tabs and dogs are located without said region of mutual adjacency.

14. The heart valve prosthesis of claim 11 wherein said sewing cuff is coupled to said substructure annulus with sutures.

15. The heart valve prosthesis of claim 11 in which:

said substructure annulus includes an array of sewing apertures extending therethrough; and

said heart valve sewing cuff is attached to said substructure annulus with sutures extending within said sewing apertures.

16. The heart valve prosthesis of claim 11 wherein said attachment portion dogs extend outwardly from said circular periphery at radial locations offset from the radial locations of said tabs.

17. The heart valve prosthesis of claim 16 in which said substructure attachment portion tabs and dogs are located without said region of mutual adjacency.

18. The heart valve prosthesis of claim 1 wherein:

A) said substructure comprises a cylinder having a periphery, first and second ends, and a diameter, said cylinder further comprising a generally flat annulus extending radially outwardly from the periphery at said first end, said generally flat annulus having an aortic side and a ventricular side abuttable on the aortic side of said heart valve annulus;

B) said attachment portion comprises three tissue engaging tabs extending outwardly from said periphery and three tissue engaging resiliently outwardly biased dogs extending from said second end of said cylinder; and

C) said sewing cuff is coupled to said substructure adjacent the atrial side of said generally flat annulus.

19. The heart valve prosthesis of claim 18 in which said substructure attachment portion tabs extend radially outwardly from said annulus outer periphery a distance effective to resist blood backflow pressure.

20. The heart valve prosthesis of claim 18 in which said substructure attachment portion tabs and dogs are located without said region of mutual adjacency.

21. The heart valve prosthesis of claim 18 in which said mechanical heart valve sewing cuff is attached to said substructure with sutures.

22. The heart valve prosthesis of claim 18 in which:

said substructure includes an array of sewing apertures extending there-through in the vicinity of said annulus; and

said heart valve sewing cuff is attached to said substructure with sutures extending within said sewing apertures.