Bioresorbable heart valve support

• US 5,895,420 A
• Filed: 09/15/1997
• Issued: 04/20/1999
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Tweden, Katherine S., Mirsch, M. William II
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CUDDIHY, FRANCIS KEVIN
• Application Number:
  US08/929,807
• Time in Patent Office: 582 Days
• Field of Search: 623/1, 623/2, 623/900, 623/66, 623/11, 623/12
• US Class Current: 623/2.38
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

This invention relates to bioprosthetic heart valve stents that are fashioned of bioresorbable materials. Such stents may be configured as sheaths or frames contoured to the shape of a valvular graft. The stents are eventually resorbed by the patent, leaving a functional "stentless" valve with improved hemodynamic characteristics compared to stented valve implants.

Claims

1. A bioprosthetic heart valve comprising a valvular tissue graft secured to a biocompatible, resorbable heart valve stent, said stent having an open, interconnected porosity, said bioprosthetic heart valve being appropriate for joining with cardiac tissue, wherein said stent is operably resorbed following substantially complete healing of said heart valve with said cardiac tissue.

2. The bioprosthetic heart valve of claim 1, wherein said stent comprises a biocompatible, resorbable polymer.

3. The bioprosthetic heart valve of claim 1, wherein said polymer is selected from the group consisting of dextran, hydroxyethyl starch, gelatin, derivatives of gelatin, polyvinylpyrrolidone, polyvinyl alcohol, poly N-(2-hydroxypropyl)methacrylamide!, polyglycols, polyesters, poly (orthoesters), poly (ester-amides) and polyanhydrides.

4. The bioprosthetic heart valve of claim 3, wherein said polyesters are selected form the group consisting of poly (hydroxy acids) and copolymers thereof, poly ( epsilon!-caprolactone), poly (dimethyl glycolic acid) and poly (hydroxy butyrate).

5. The bioprosthetic heart valve of claim 2, wherein said polymer is selected from the group consisting of D,L-polylactic acid, L-polylactic acid, glycolic acid and copolymers of D,L-polylactic acid, L-polylactic acid, and glycolic acid.

6. The bioprosthetic heart valve of claim 1, wherein said stent comprises a frame contoured to the shape of said valvular tissue graft.

7. The bioprosthetic heart valve of claim 1, wherein said stent comprises a sheath contoured to the shape of said valvular tissue graft.

8. The bioprosthetic heart valve of claim 1, wherein said stent having nonuniform rigidity is selected such that the native compliance of adjacent host structures is maintained.

9. A bioprosthetic heart valve comprising a valvular tissue graft secured to a biocompatible, resorbable heart valve stent, said stent having nonuniform rigidity selected such that the native compliance of adjacent host structures is maintained, said bioprosthetic heart valve being appropriate for joining with cardiac tissue, wherein said stent is operably resorbed following substantially complete healing of said heart valve with said cardiac tissue.

10. The bioprosthetic heart valve of claim 9, wherein said stent comprises a biocompatible, resorbable polymer.

11. The bioprosthetic heart valve of claim 9, wherein said polymer is selected from the group consisting of dextran, hydroxyethyl starch, gelatin, derivatives of gelatin, polyvinylpyrrolidone, polyvinyl alcohol, poly N-(2-hydroxypropyl)methacrylamide!, polyglycols, polyesters, poly (orthoesters), poly (ester-amides) and polyanhydrides.

12. The bioprosthetic heart valve of claim 11, wherein said polyesters are selected form the group consisting of poly (hydroxy acids) and copolymers thereof, poly ( epsilon!-caprolactone), poly (dimethyl glycolic acid) and poly (hydroxy butyrate).

13. The bioprosthetic heart valve of claim 10, wherein said polymer is selected from the group consisting of D,L-polylactic acid, L-polylactic acid, glycolic acid and copolymers of D,L-polylactic acid, L-polylactic acid, and glycolic acid.

14. The bioprosthetic heart valve of claim 9, wherein said stent comprises a frame contoured to the shape of said valvular tissue graft.

15. The bioprosthetic heart valve of claim 9, wherein said stent comprises a sheath contoured to the shape of said valvular tissue.