Pre-assembled bioprosthetic valve and sealed conduit

• US 9,301,835 B2
• Filed: 05/30/2013
• Issued: 04/05/2016
• Est. Priority Date: 06/04/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Campbell, Louis A., Bobo, Donald E. Jr., Wright, Gregory A., Cheung, Tak G.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US13/906,166
• Publication Number:
  US 20130325111A1
• Time in Patent Office: 1,041 Days
• Field of Search: 623 21- 219
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2310/00371 Collagen
• CPC Class Codes: A61F 2310/00383 Gelatin
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/222 Gelatin
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

A valved conduit including a bioprosthetic valve, such as a heart valve, and a tubular conduit sealed with a bioresorbable material. The bioprosthetic heart valve includes prosthetic tissue that has been treated such that the tissue may be stored dry for extended periods without degradation of functionality of the valve. The bioprosthetic heart valve may have separate bovine pericardial leaflets or a whole porcine valve. The sealed conduit includes a tubular matrix impregnated with a bioresorbable medium such as gelatin or collagen. The valved conduit is stored dry in packaging in which a desiccant pouch is supplied having a capacity for absorbing moisture within the packaging limited to avoid drying the bioprosthetic tissue out beyond a point where its ability to function in the bioprosthetic heart valve is compromised. The heart valve may be sewn within the sealed conduit or coupled thereto with a snap-fit connection.

Claims

1. A valved conduit, comprising:

a bioprosthetic valve including bioprosthetic tissue, the valve having been treated such that the tissue may be stored dry for extended periods without degradation of functionality of the valve; and

a conduit sealed with a bioresorbable medium to which the bioprosthetic valve is coupled so as to provide the valved conduit, wherein the conduit is secured to the bioprosthetic valve using a snap-fit connection.

2. The valved conduit of claim 1, wherein the bioprosthetic valve is a heart valve with flexible leaflets supported by commissures, and has a sewing ring, and a coupling ring attaches to the sewing ring and surrounds the commissures and has an open end that extends to provide the snap-fit connection with an inflow end of the conduit.

3. The valved conduit of claim 1, wherein the bioprosthetic valve is a heart valve and includes bovine pericardial leaflets, and the conduit comprises a tubular matrix impregnated with gelatin.

4. The valved conduit of claim 1, wherein the bioprosthetic valve is a heart valve and includes bovine pericardial leaflets, and the conduit comprises a tubular matrix impregnated with collagen.

5. The valved conduit of claim 1, wherein the bioprosthetic valve couples within the conduit such that the conduit extends on both ends of the valve to provide both inflow and outflow extensions.

6. The valved conduit of claim 1, wherein the tissue has been cross-linked using glutaraldehyde or other aldehyde containing agents, treated with a capping agent, and is dehydrated with a glycerol solution.

7. The valved conduit of claim 1, wherein the bioprosthetic valve couples within the conduit such that the conduit extends on both ends of the valve to provide both inflow and outflow extensions.

8. A packaged valved conduit, comprising:

a bioprosthetic valve including bioprosthetic tissue, the valve having been treated such that the tissue may be stored dry for extended periods without degradation of functionality of the valve, the bioprosthetic valve being coupled to a conduit sealed with a bioresorbable medium to provide the valved conduit, wherein the bioprosthetic valve is a heart valve and includes bovine pericardial leaflets, and the conduit comprises a tubular matrix impregnated with collagen; and

packaging for the valved conduit including at least one sterile container in which the valved conduit is stored without a preserving solution.

9. The packaged valved conduit of claim 8, wherein the packaging comprises a dual layer packaging with the valved conduit sealed within an inner gas-permeable sterile barrier to enable gas sterilization and an outer gas-impermeable barrier to prevent long term oxidation of the bioprosthetic tissue.

10. The packaged valved conduit of claim 8, wherein the conduit comprises a tubular matrix impregnated with gelatin, and further including a desiccant pouch provided within the packaging having a capacity for absorbing moisture within the packaging limited to avoid drying the bioprosthetic tissue out beyond a point where its ability to function as a bioprosthetic valve is compromised.

11. The packaged valved conduit of claim 8, wherein the tissue has been cross-linked using glutaraldehyde or other aldehyde containing agents, treated with a capping agent, and dehydrated with a glycerol solution.

12. The packaged valved conduit of claim 8, wherein the outer gas-impermeable barrier comprises a storage pouch having a dual seal system on its open end which provides both a gas-permeable portion and a gas-impermeable portion.

13. A method of preparing and delivering a valved conduit, comprising:

procuring a pre-assembled valved conduit including a bioprosthetic valve having bioprosthetic tissue coupled to a conduit sealed with a bioresorbable medium, the valved conduit being stored in a dry package, and wherein the conduit is secured to the bioprosthetic valve using a snap-fit connection;

opening the dry package and removing the valved conduit; and

delivering the valved conduit to an implantation site.

14. The method of claim 13, wherein the bioprosthetic valve is a heart valve with bioprosthetic tissue leaflets supported by commissures, and has a sewing ring, and a coupling ring attaches to the sewing ring and surrounds the commissures and has an open end that extends to provide the snap-fit connection with an inflow end of the conduit.

15. The method of claim 13, wherein the bioprosthetic valve is a heart valve and includes bovine pericardial leaflets, and the conduit comprises a tubular matrix impregnated with gelatin.

16. The method of claim 13, wherein the bioprosthetic valve is a heart valve and includes bovine pericardial leaflets, and the conduit comprises a tubular matrix impregnated with collagen.

17. The method of claim 13, wherein the bioprosthetic valve couples within the conduit such that the conduit extends on both ends of the valve to provide both inflow and outflow extensions.

18. The method of claim 13, wherein the tissue has been cross-linked using glutaraldehyde or other aldehyde containing agents, treated with a capping agent, and dehydrated with a glycerol solution.