Pre-assembled bioprosthetic valve conduit and method of delivery

• US 10,130,466 B2
• Filed: 03/24/2016
• Issued: 11/20/2018
• Est. Priority Date: 06/04/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Campbell, Louis A., Bobo, Jr., Donald E., Wright, Gregory A., Cheung, Tak G.
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/079,854
• Publication Number:
  US 20160270913A1
• Time in Patent Office: 971 Days
• Field of Search: 623 21- 219
• 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 pre-assembled valved conduit, comprising:

a bioprosthetic heart valve including bioprosthetic tissue leaflets, 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 having a sewing ring encircling an inflow end, wherein the tissue leaflets are supported by three commissure posts evenly located around the valve that project in an outflow direction, with three convex valve cusps therebetween extending in an inflow direction;

a conduit sealed with a bioresorbable medium that is coupled to the sewing ring with sutures so as to form the valved conduit including three axial marker lines provided on an exterior of the conduit aligned with and signifying the locations of the three commissure posts;

a valve holder attached to the bioprosthetic valve on an outflow side of the valve cusps; and

an elongated delivery handle connected to the valve holder and extending through the conduit so as to project from an outlet end thereof.

2. The valved conduit of claim 1, wherein the heart valve is located at an inlet end of the conduit that wraps around the sewing ring.

3. The valved conduit of claim 2, wherein the sutures coupling the conduit inlet end to the sewing ring pass through the entire sewing ring from inflow to outflow sides thereof.

4. The valved conduit of claim 1, wherein the heart valve includes bovine pericardial leaflets, and the conduit comprises a tubular matrix impregnated with gelatin or 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 bioprosthetic tissue leaflets have been cross-linked using glutaraldehyde or other aldehyde containing agents, treated with a capping agent, and dehydrated with a glycerol solution.

7. A packaged pre-assembled valved conduit, comprising:

a pre-assembled valved conduit including a bioprosthetic valve with bioprosthetic tissue leaflets, 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;

a valve holder attached to the bioprosthetic valve on an outflow side thereof; and

an elongated delivery handle connected to the valve holder and extending through the conduit so as to project from an outlet end thereof; and

packaging for the valved conduit including at least one sterile container in which the valved conduit, holder and handle are stored assembled without a preserving solution.

8. The packaged pre-assembled valved conduit of claim 7, 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.

9. The packaged pre-assembled 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.

10. The packaged pre-assembled valved conduit of claim 7, 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 pre-assembled valved conduit of claim 7, wherein the bioprosthetic tissue leaflets have been cross-linked using glutaraldehyde or other aldehyde containing agents, treated with a capping agent, and dehydrated with a glycerol solution.

12. A pre-assembled valved conduit, comprising:

a bioprosthetic valve including bioprosthetic tissue leaflets cross-linked using glutaraldehyde or other aldehyde containing agents, treated with a capping agent, and dehydrated with a glycerol solution such that the tissue leaflets may be stored dry for extended periods without degradation of functionality of the valve, the bioprosthetic valve having a sewing ring encircling an inflow end;

a conduit sealed with a bioresorbable medium that is coupled to the sewing ring with sutures so as to form the valved conduit;

a valve holder attached to the bioprosthetic valve on an outflow side thereof; and

an elongated delivery handle connected to the valve holder and extending through the conduit so as to project from an outlet end thereof.

13. The valved conduit of claim 12, wherein the bioprosthetic valve is a heart valve located at an inlet end of the conduit that wraps around the sewing ring.

14. The valved conduit of claim 12, 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.

15. The valved conduit of claim 12, further including packaging for the valved conduit including at least one sterile container in which the valved conduit, holder and handle are stored assembled without a preserving solution.

16. The valved conduit of claim 15, 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.

17. The valved conduit of claim 15, 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.