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公开(公告)号:US11027870B2
公开(公告)日:2021-06-08
申请号:US15357998
申请日:2016-11-21
Applicant: Edwards Lifesciences Corporation
Inventor: Abishek Gautam , Gregory A. Wright
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.
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公开(公告)号:US10561486B2
公开(公告)日:2020-02-18
申请号:US16254539
申请日:2019-01-22
Applicant: Edwards Lifesciences Corporation
Inventor: Gregory G. Liburd , Abishek Gautam
Abstract: 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 comprise a holder comprising an engagement structure configured for removably attaching a bioprosthetic heart valve, the holder comprising a shaft. The packaging assembly can also include a storage tray comprising a cavity and an insert sized to provide a cap over the cavity of the storage tray, the insert comprising a slot having a closed central end and an open outer periphery. The shaft of the holder can be non-rotatably retained at the closed central end, wherein the insert defines a flat, generally planar disc comprising at least one of outward projections and flow passages.
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3.
公开(公告)号:US20170073099A1
公开(公告)日:2017-03-16
申请号:US15357998
申请日:2016-11-21
Applicant: Edwards Lifesciences Corporation
Inventor: Abishek Gautam , Gregory A. Wright
CPC classification number: B65B55/18 , A61F2/0095 , A61F2/2412 , A61F2/2415 , A61F2/2418 , A61F2/2427 , A61F2/2433 , A61F2250/0036
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.
Abstract translation: 用于干假体组织心脏瓣膜及其递送系统的包装包括允许组织植入物进行气体灭菌的初级无菌屏障,以及在长期储存期间还防止植入物氧化的次级无菌屏障。 干组织心脏瓣膜及其输送系统被放置在诸如刚性托盘的主容器内,其限制其中的部件的移动。 将主容器放置在次级容器中,例如另一刚性托盘或柔性袋,然后将组件消毒。 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,之后可以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。 可以提供用于外科心脏瓣膜的可折叠递送手柄,其减小了包装的尺寸,并且可用于各种类型的假体心脏瓣膜。
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公开(公告)号:US20190151068A1
公开(公告)日:2019-05-23
申请号:US16254539
申请日:2019-01-22
Applicant: Edwards Lifesciences Corporation
Inventor: Gregory G. Liburd , Abishek Gautam
CPC classification number: A61F2/0095 , A01N1/0263 , A61F2/2412 , A61L2/0094 , A61L2/20 , A61L2/206 , A61L2202/181 , A61L2202/21 , B65D77/003 , B65D77/20 , B65D77/26
Abstract: 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 comprise a holder comprising an engagement structure configured for removably attaching a bioprosthetic heart valve, the holder comprising a shaft. The packaging assembly can also include a storage tray comprising a cavity and an insert sized to provide a cap over the cavity of the storage tray, the insert comprising a slot having a closed central end and an open outer periphery. The shaft of the holder can be non-rotatably retained at the closed central end, wherein the insert defines a flat, generally planar disc comprising at least one of outward projections and flow passages.
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公开(公告)号:US20180228605A1
公开(公告)日:2018-08-16
申请号:US15918572
申请日:2018-03-12
Applicant: Edwards Lifesciences Corporation
Inventor: Frederic B. Hodshon , Rafael Pintor , August R. Yambao , Abishek Gautam , Louis A. Campbell , Lawrence J. Farhat , Tammy Huntley , Faisal Kalam , Travis Zenyo Oba , Qinggang Zeng
CPC classification number: A61F2/2427 , A61F2/0095 , A61F2/24 , A61F2/2409 , A61F2/2412 , A61F2/2418 , A61F2220/0075
Abstract: 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:US20200179093A1
公开(公告)日:2020-06-11
申请号:US16791894
申请日:2020-02-14
Applicant: Edwards Lifesciences Corporation
Inventor: Gregory G. Liburd , Abishek Gautam
Abstract: 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:US10195013B2
公开(公告)日:2019-02-05
申请号:US15935483
申请日:2018-03-26
Applicant: Edwards Lifesciences Corporation
Inventor: Gregory G. Liburd , Abishek Gautam
Abstract: 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 comprise a holder comprising an engagement structure configured for removably attaching a bioprosthetic heart valve, the holder comprising a shaft. The packaging assembly can also include a storage tray comprising a cavity and an insert sized to provide a cap over the cavity of the storage tray, the insert comprising a slot having a closed central end and an open outer periphery. The shaft of the holder can be non-rotatably retained at the closed central end, wherein the insert defines a flat, generally planar disc comprising at least one of outward projections and flow passages.
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公开(公告)号:US20180206969A1
公开(公告)日:2018-07-26
申请号:US15935483
申请日:2018-03-26
Applicant: Edwards Lifesciences Corporation
Inventor: Gregory G. Liburd , Abishek Gautam
CPC classification number: A61F2/0095 , A01N1/0263 , A61F2/2412 , A61L2/0094 , A61L2/20 , A61L2/206 , A61L2202/181 , A61L2202/21 , B65D77/003 , B65D77/20 , B65D77/26
Abstract: 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 comprise a holder comprising an engagement structure configured for removably attaching a bioprosthetic heart valve, the holder comprising a shaft. The packaging assembly can also include a storage tray comprising a cavity and an insert sized to provide a cap over the cavity of the storage tray, the insert comprising a slot having a closed central end and an open outer periphery. The shaft of the holder can be non-rotatably retained at the closed central end, wherein the insert defines a flat, generally planar disc comprising at least one of outward projections and flow passages.
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公开(公告)号:US09918836B2
公开(公告)日:2018-03-20
申请号:US15068324
申请日:2016-03-11
Applicant: Edwards Lifesciences Corporation
Inventor: Fred Hodshon , Rafael Pintor , August R. Yambao , Abishek Gautam , Louis A. Campbell , Lawrence J. Farhat , Tammy Huntley , Faisal Kalam , Travis Zenyo Oba , Qinggang Zeng
CPC classification number: A61F2/2427 , A61F2/0095 , A61F2/24 , A61F2/2409 , A61F2/2412 , A61F2/2418 , A61F2220/0075
Abstract: 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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10.
公开(公告)号:US20160262882A1
公开(公告)日:2016-09-15
申请号:US15068324
申请日:2016-03-11
Applicant: Edwards Lifesciences Corporation
Inventor: Fred Hodshon , Rafael Pintor , August R. Yambao , Abishek Gautam , Louis A. Campbell , Lawrence J. Farhat , Tammy Huntley , Faisal Kalam , Travis Zenyo Oba , Qinggang Zeng
IPC: A61F2/24
CPC classification number: A61F2/2427 , A61F2/0095 , A61F2/24 , A61F2/2409 , A61F2/2412 , A61F2/2418 , A61F2220/0075
Abstract: 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.
Abstract translation: 用于假体心脏瓣膜的包装,包括用于将心脏瓣膜牢固地保持在罐内并有助于从其中取出的组件。 组件包括紧密地配合在罐内的包装套筒,并具有用于固定阀座的夹子结构。 与以前的设计相反,在一个实施例中,阀保持器向下指向罐中,并且阀向上保持流入端。 阀可以具有柔性小叶,并且在轴的端部上的小叶分离构件延伸穿过叶片并与阀座联接。 然后可以将包装套筒,阀和保持器的组件从罐中移除,以及与保持器连接的阀输送管,或者与叶片分离构件相连。 包装套筒可以分叉成在活动铰链处连接的两个半部,以便于从阀/支架子组件周围移除。
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