# US 9,301,835 B2 · Pre-assembled bioprosthetic valve and sealed conduit > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,301,835 B2 - Document ID: US9301835B2 - Status: Granted - Kind: B2 - Application number: 13/906,166 - Filed: 2013-05-30 - Published: 2013-12-05 - Granted: 2016-04-05 - Earliest claimed: 2012-06-04 - Assignees: Edwards Lifesciences Corporation - Applicants: Edwards Lifesciences Corporation - Inventors: Louis A. Campbell; Donald E. Bobo, Jr.; Gregory A. Wright; Tak G. Cheung - Web page: https://patentgrep.com/patent/US9301835B2 ## CPC - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)} - A61F 2/06: Blood vessels - A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)} - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2/2415: {Manufacturing methods} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61L 27/222: {Gelatin} - A61L 27/24: Collagen - A61L 27/3625: {Vascular tissue, e.g. heart valves} - A61L 27/3687: {characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents} - A61L 27/507: {for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062)} - A61F 2210/0004: bioabsorbable - A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable - A61F 2310/00371: Collagen - A61F 2310/00383: Gelatin - A61L 2430/20: for reconstruction of the heart, e.g. heart valves - A61L 2430/40: Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) ## 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 ### Claim 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. ### Claim 2 (depends on 1) 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. ### Claim 3 (depends on 1) 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. ### Claim 4 (depends on 1) 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. ### Claim 5 (depends on 1) 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. ### Claim 6 (depends on 1) 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. ### Claim 7 (depends on 1) 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. ### Claim 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. ### Claim 9 (depends on 8) 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. ### Claim 10 (depends on 8) 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. ### Claim 11 (depends on 8) 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. ### Claim 12 (depends on 8) 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. ### Claim 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. ### Claim 14 (depends on 13) 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. ### Claim 15 (depends on 13) 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. ### Claim 16 (depends on 13) 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. ### Claim 17 (depends on 13) 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. ### Claim 18 (depends on 13) 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.