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公开(公告)号：US20200315795A1
公开(公告)日：2020-10-08
申请号：US16908375
申请日：2020-06-22
发明人： Frederic B. Hodshon , Rafael Pintor , August R. Yambao , Abhishek Gautam , Louis A. Campbell , Lawrence J. Farhat , Tammy Huntley , Faisal Kalam , Travis Zenyo Oba , Qinggang Zeng
摘要： Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within ajar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly.
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公开(公告)号：US20140202908A1
公开(公告)日：2014-07-24
申请号：US14221101
申请日：2014-03-20
发明人： Gregory G. Liburd , Abhishek Gautam
IPC分类号： A61F2/00
CPC分类号： A61F2/0095 , A01N1/0263 , A61F2/2412 , A61L2/0094 , A61L2/20 , A61L2/206 , A61L2202/181 , A61L2202/21 , B65D77/003 , B65D77/20 , B65D77/26
摘要： Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that prevents oxidation of the implant during storage. Tissue heart valves are placed inside an inner tray and sealed with a gas-permeable lid. The inner tray is placed within an outer sterile barrier and the assembly is 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 is closed to seal out any further oxygen contact with the tissue implant. Alternatively, the inner tray is placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier.
摘要翻译： 包括用于在储存期间包括用于稳定干假体组织植入物（例如心脏瓣膜）的组件的假体心脏瓣膜。 包装组件包括允许组织植入物进行气体灭菌的初级无菌屏障，以及在储存期间防止植入物氧化的次级无菌屏障。 组织心脏瓣膜置于内部托盘内并用透气性盖子密封。 将内托盘放置在外部无菌屏障内，并将组件灭菌。 外部无菌屏障可以包括双重密封，使得可以关闭第一气体可渗透密封件用于灭菌，之后关闭第二气体不可渗透密封件以密封与组织植入物的任何进一步的氧接触。 或者，将内部托盘放置在无菌袋中，并将组件气体灭菌，然后将整个组件放置在提供不渗透屏障的另一个小袋内。
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公开(公告)号：US09539080B2
公开(公告)日：2017-01-10
申请号：US14221101
申请日：2014-03-20
发明人： Gregory G. Liburd , Abhishek Gautam
CPC分类号： A61F2/0095 , A01N1/0263 , A61F2/2412 , A61L2/0094 , A61L2/20 , A61L2/206 , A61L2202/181 , A61L2202/21 , B65D77/003 , B65D77/20 , B65D77/26
摘要： Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that prevents oxidation of the implant during storage. Tissue heart valves are placed inside an inner tray and sealed with a gas-permeable lid. The inner tray is placed within an outer sterile barrier and the assembly is 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 is closed to seal out any further oxygen contact with the tissue implant. Alternatively, the inner tray is placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier.
摘要翻译： 包括用于在储存期间包括用于稳定干假体组织植入物（例如心脏瓣膜）的组件的假体心脏瓣膜。 包装组件包括允许组织植入物进行气体灭菌的初级无菌屏障，以及在储存期间防止植入物氧化的次级无菌屏障。 组织心脏瓣膜置于内部托盘内并用透气性盖子密封。 将内托盘放置在外部无菌屏障内，并将组件灭菌。 外部无菌屏障可以包括双重密封，使得可以关闭第一透气密封件用于灭菌，之后关闭第二气体不可渗透的密封件以密封与组织植入物的任何进一步的氧接触。 或者，将内部托盘放置在无菌袋中，并将组件气体灭菌，然后将整个组件放置在提供不渗透屏障的另一个小袋内。
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公开(公告)号：US11911256B2
公开(公告)日：2024-02-27
申请号：US16791894
申请日：2020-02-14
发明人： Gregory G. Liburd , Abhishek Gautam
CPC分类号： A61F2/0095 , A01N1/0263 , A61F2/2412 , A61L2/0094 , B65D77/003 , B65D77/20 , B65D77/26 , A61L2/20 , A61L2/206 , A61L2202/181 , A61L2202/21
摘要： Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly can be used for storing a bioprosthetic heart valve without a liquid preservative solution. The packaging assembly can have a valve holder configured for removably attaching a bioprosthetic heart valve, a storage tray comprising an open end and a cavity, and a retaining member configured for removably attaching the valve holder. The retaining member can be generally planar and have a slot having a closed end and an open outer end. The valve holder can be configured to be retained at the closed end of the slot in the retaining member.
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公开(公告)号：US11311378B2
公开(公告)日：2022-04-26
申请号：US16908375
申请日：2020-06-22
发明人： Frederic B. Hodshon , Rafael Pintor , August R. Yambao , Abhishek Gautam , Louis A. Campbell , Lawrence J. Farhat , Tammy Huntley , Faisal Kalam , Travis Zenyo Oba , Qinggang Zeng
摘要： Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly.
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公开(公告)号：US20170112608A1
公开(公告)日：2017-04-27
申请号：US15400934
申请日：2017-01-06
发明人： Gregory G. Liburd , Abhishek Gautam
CPC分类号： A61F2/0095 , A01N1/0263 , A61F2/2412 , A61L2/0094 , A61L2/20 , A61L2/206 , A61L2202/181 , A61L2202/21 , B65D77/003 , B65D77/20 , B65D77/26
摘要： Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier feat permits gas sterilization of the tissue implant, and a secondary sterile barrier that prevents oxidation of the implant during storage. Tissue heart valves are placed inside, an inner tray and sealed with, a gas-permeable lid. The inner tray is placed within an outer sterile barrier and the assembly is 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 is closed to seal out any further oxygen, contact with the tissue implant Alternatively, the inner tray is placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier.
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公开(公告)号：US20240180685A1
公开(公告)日：2024-06-06
申请号：US18443183
申请日：2024-02-15
发明人： Gregory G. Liburd , Abhishek Gautam
CPC分类号： A61F2/0095 , A01N1/0263 , A61F2/2412 , A61L2/0094 , B65D77/003 , B65D77/20 , B65D77/26 , A61L2/20 , A61L2/206 , A61L2202/181 , A61L2202/21
摘要： Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly 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. Tissue heart valves may be placed or suspended within a cavity of an inner rigid tray with a gas-permeable lid sealed thereon, and a cap placed over the cavity to limit movement of the valve therein. The inner tray is placed within an outer sterile barrier, 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. Alternatively, the inner tray may be placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier to the surrounding atmosphere to prevent oxidation of the tissue implant.
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公开(公告)号：US09937030B2
公开(公告)日：2018-04-10
申请号：US15400934
申请日：2017-01-06
发明人： Gregory G. Liburd , Abhishek Gautam
CPC分类号： A61F2/0095 , A01N1/0263 , A61F2/2412 , A61L2/0094 , A61L2/20 , A61L2/206 , A61L2202/181 , A61L2202/21 , B65D77/003 , B65D77/20 , B65D77/26
摘要： A packaging assembly for storing a bioprosthetic heart valve without a liquid preservative solution is provided. The packaging system includes a holder, a cage, a storage tray and an insert sized to provide a cap over the cavity of the storage tray. The holder comprises a shaft and an engagement structure configured for removably attaching a bioprosthetic heart valve. The cage comprises an upper end, the cage configured to at least partially enclose the bioprosthetic heart valve. The storage tray comprises a cavity for housing the cage. The insert comprises a slot having a closed central end and an open outer periphery, the shaft of the holder being non-rotatably retained at the closed central end. The insert defines a flat, generally planar disc comprising at least one of outward projections and flow passages. The packaging assembly does not comprise a liquid preservative solution.
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