# US 11,027,870 B2 · Prosthetic heart valve delivery systems and packaging > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,870 B2 - Document ID: US11027870B2 - Status: Granted - Kind: B2 - Application number: 15/357,998 - Filed: 2016-11-21 - Published: 2017-03-16 - Granted: 2021-06-08 - Earliest claimed: 2010-12-16 - Assignees: Edwards Lifesciences Corporation - Applicants: Edwards Lifesciences Corporation - Inventors: Abishek Gautam; Gregory A. Wright - Web page: https://patentgrep.com/patent/US11027870B2 ## CPC - B65B 55/18: by liquids or gases (B65B55/14 takes precedence) - A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)} - A61F 2/2415: {Manufacturing methods} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/2433: {using balloon catheter} - A61M 25/002: {Packages specially adapted therefor (combined with means for introducing catheters, e.g. dispensers, A61M25/0113); catheter kit packages (for surgical articles A61B50/30)} - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61F 2250/0036: differing in thickness - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) - 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) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Packaging for dry prosthetic tissue heart valves and their delivery systems includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that also prevents oxidation of the implant during long-term storage. Dry tissue heart valves and their delivery systems are placed within a primary container such as a rigid tray that limits movement of the components therein. The primary container is placed within a secondary container, such as another rigid tray or a flexible pouch, and the assembly is then sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal can be closed to seal out any further oxygen contact with the tissue implant. A collapsible delivery handle for a surgical heart valve may be provided which reduces the size of the packaging, and is useful for various types of prosthetic heart valves. ## Claims ### Claim 1 A method for packaging a bioprosthetic heart valve and its delivery system, the method comprising: forming flexible leaflets from a bioprosthetic tissue, wherein the bioprosthetic tissue is treated with a polyhydric alcohol; attaching the flexible leaflets to an expandable stent structure to form a bioprosthetic heart valve; coupling the bioprosthetic heart valve to a delivery system, wherein the delivery system comprises a handle at one end and an expandable balloon at the other end, wherein the bioprosthetic heart valve is positioned around the expandable balloon; packaging the bioprosthetic heart valve and the delivery system in a primary container after the coupling; and packaging the primary container comprising the bioprosthetic heart valve and the delivery system in a secondary container; wherein the primary container is gas-permeable and comprises a tray having an opening and a lid attached to the try to cover the opening, the tray having a first cavity for the bioprosthetic heart valve and a second cavity for the delivery system, the first and second cavities being configured to retain and stabilize the bioprosthetic heart valve and the delivery system within the primary container and wherein the delivery system comprises passages to permit gas flow in and out of the delivery system; wherein the secondary container is convertible from being gas-permeable to gas-impermeable; and wherein the primary container and the secondary container contain no liquid preservative solution. ### Claim 2 (depends on 1) The method of claim 1, wherein the flexible leaflets have been conditioned such that the flexible leaflets have varying thicknesses at different regions. ### Claim 3 (depends on 2) The method of claim 2, wherein the flexible leaflets are thinner in a middle region and thicker in at least a portion of an edge region. ### Claim 4 (depends on 1) The method of claim 1, further comprising treating the bioprosthetic tissue with a calcification mitigant. ### Claim 5 (depends on 4) The method of claim 4, wherein the calcification mitigant is one or both of a capping agent and an antioxidant. ### Claim 6 (depends on 1) The method of claim 1, wherein the expansion balloon is in a collapsed state prior to being packaged in the primary container. ### Claim 7 (depends on 1) The method of claim 1, wherein the bioprosthetic heart valve is suspended within the second cavity of the primary container. ### Claim 8 (depends on 7) The method of claim 7, wherein the bioprosthetic heart valve does not touch the tray. ### Claim 9 (depends on 1) The method of claim 1, wherein the tray comprises a gas-permeable molded material. ### Claim 10 (depends on 9) The method of claim 9, wherein the tray is made of a polyethylene terephthalate copolymer (PETG). ### Claim 11 (depends on 9) The method of claim 9, wherein the lid comprises a gas permeable material. ### Claim 12 (depends on 11) The method of claim 11, wherein the gas-permeable material comprises high-density polyethylene fibers. ### Claim 13 (depends on 1) The method of claim 1, further comprising a desiccant in at least one of the primary and secondary containers. ### Claim 14 (depends on 1) The method of claim 1, wherein the secondary container is one of a storage tray or a pouch. ### Claim 15 (depends on 14) The method of claim 14, wherein the secondary container comprises a dual seal system comprising first and second seals and a gas-permeable portion between the first and second seals, wherein the secondary container is gas-permeable when the first seal is closed and wherein the secondary container is gas-impermeable when the second seal is closed. ### Claim 16 (depends on 15) The method of claim 15, further comprising closing the first seal of the secondary container after packaging the primary container comprising the bioprosthetic heart valve and the delivery system in the secondary container. ### Claim 17 (depends on 16) The method of claim 16, further comprising sterilizing the primary container and the secondary container after closing the first seal. ### Claim 18 (depends on 17) The method of claim 17, further comprising closing the second seal after sterilizing the primary container and secondary container. ### Claim 19 (depends on 18) The method of claim 18, further comprising packaging the primary and secondary containers in an outer shelf box after sterilizing the primary container and the secondary container. ### Claim 20 (depends on 19) The method of claim 19, wherein the shelf box provides temperature monitoring. ### Claim 21 (depends on 1) The method of claim 1, wherein the secondary container is a gas-impermeable tray having an open end and a secondary cavity that is shaped and sized to allow the primary container to nest within the secondary container. ### Claim 22 (depends on 21) The method of claim 21, wherein the secondary container further comprises a lid configured to cover the open end of the secondary cavity, the lid comprising a gas-permeable portion. ### Claim 23 (depends on 22) The method of claim 22, further comprising a gas-impermeable label that is sized to cover the gas-permeable portion of the lid to render the lid gas-impermeable. ### Claim 24 (depends on 1) The method of claim 1, further comprising sterilizing the primary container after packaging the bioprosthetic heart valve and delivery system in the primary container.