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1. 发明申请

WO2011119754A2 METHODS OF CONDITIONING SHEET BIOPROSTHETIC TISSUE 审中-公开
标题翻译：调节片生物组织的方法
公开(公告)号：WO2011119754A2
公开(公告)日：2011-09-29
申请号：PCT/US2011/029654
申请日：2011-03-23
申请人： EDWARDS LIFESCIENCES CORPORATION , DOVE, Jeffrey, S. , TIAN, Bin , SCHNEIDER, Ralph , COHEN, Jeffrey, S. , JANKOVIC, Ivan , MIGLIAZZA, John, F. , WRIGHT, Gregory, A. , YOUNG, James, M. , CAMPBELL, Louis, A.
发明人： DOVE, Jeffrey, S. , TIAN, Bin , SCHNEIDER, Ralph , COHEN, Jeffrey, S. , JANKOVIC, Ivan , MIGLIAZZA, John, F. , WRIGHT, Gregory, A. , YOUNG, James, M. , CAMPBELL, Louis, A.
IPC分类号： A61F2/24 , A61L27/38 , D06M10/00 , D06M10/04
CPC分类号： A61F2/2415 , A61B18/20 , A61F2/02 , A61F2/24 , A61F2/2409 , A61F2/2418 , A61F2002/30324 , A61F2250/0036 , A61L27/3604 , A61L27/3625 , A61L27/3691 , A61L27/507 , A61L2300/60 , A61L2430/20 , B65B55/18 , B65B63/02
摘要： Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes. The finally thinned membrane may then be treated by capping of calcification nucleation sites and borohydride reduction. The leaflets may be formed to have more than one region of uniform thickness, such as a thicker peripheral sewing region.
摘要翻译：生物假体材料调理方法采用牛心包膜。指向膜的纤维表面并相对于其移动的激光将膜的厚度减小到特定的均匀厚度并平滑表面。选择激光器的波长，功率和脉冲速率，这将使纤维表面平滑，并将表面烧蚀到合适的厚度。或者，使用皮肤表面从膜的纤维表面去除一层材料。变薄也可能采用压缩。使用交联以稳定膜的逐步压缩来避免通过非弹性压缩损伤膜。相反，膜通过加成交联结合在弹性压缩状态。上述几种稀释技术可以一起使用以获得强的薄膜。然后可以通过封闭钙化成核位点和硼氢化钠还原来处理最终变薄的膜。传单可以形成为具有多于一个均匀厚度的区域，例如较厚的外围缝合区域。

2. 发明申请

WO2012082986A2 PROSTHETIC HEART VALVE DELIVERY SYSTEMS AND PACKAGING 审中-公开
标题翻译：人工心脏瓣膜输送系统和包装
公开(公告)号：WO2012082986A2
公开(公告)日：2012-06-21
申请号：PCT/US2011/065073
申请日：2011-12-15
申请人： EDWARDS LIFESCIENCES CORPORATION , GAUTAM, Abishek , WRIGHT, Gregory, A.
发明人： GAUTAM, Abishek , WRIGHT, Gregory, A.
IPC分类号： A61F2/24 , A61M39/22 , A61F2/76
CPC分类号： B65B55/18 , A61F2/0095 , A61F2/2412 , A61F2/2415 , A61F2/2418 , A61F2/2427 , A61F2/2433 , A61F2250/0036
摘要： 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.
摘要翻译：用于干燥假体组织心脏瓣膜及其输送系统的包装包括允许组织植入物的气体消毒的主要无菌屏障和也防止植入物在长期储存期间氧化的次要无菌屏障。干燥的组织心脏瓣膜及其输送系统放置在限制其中组分的移动的初级容器例如刚性托盘内。主容器被放置在辅助容器内，例如另一个刚性托盘或柔性袋中，然后对组件进行消毒。外部无菌屏障可以包括双重密封，使得第一气体可渗透密封可以关闭以用于消毒，然后可以关闭第二气体不可渗透密封以密封与组织植入物的任何进一步的氧气接触。可以提供用于手术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人工心脏瓣膜。

3. 发明申请

WO2013184552A1 PRE-ASSEMBLED BIOPROSTHETIC VALVE AND SEALED CONDUIT 审中-公开
标题翻译：预组装的生物阀和密封管
公开(公告)号：WO2013184552A1
公开(公告)日：2013-12-12
申请号：PCT/US2013/043838
申请日：2013-06-03
申请人： EDWARDS LIFESCIENCES CORPORATION
发明人： CAMPBELL, Louis, A. , BOBO, Donald, E. , WRIGHT, Gregory, A. , CHEUNG, Tak, G.
IPC分类号： A61F2/24 , A61M39/22 , A61F2/02
CPC分类号： A61F2/2418 , A61F2/0095 , A61F2/06 , A61F2/2409 , A61F2/2412 , A61F2/2415 , A61F2/2427 , A61F2210/0004 , A61F2220/0075 , A61F2310/00371 , A61F2310/00383 , A61L27/222 , A61L27/24 , A61L27/3625 , A61L27/3687 , A61L27/507 , A61L2430/20 , A61L2430/40
摘要： 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.
摘要翻译：包括生物假体瓣膜（例如心脏瓣膜）和用生物可再吸收材料密封的管状导管的阀门导管。生物假体心脏瓣膜包括经过处理的假体组织，使得组织可以长时间保存干燥，而不会降低瓣膜的功能。生物假体心脏瓣膜可以具有单独的牛心包瓣或整个猪瓣。密封导管包括浸渍有生物可吸收介质如明胶或胶原的管状基质。带阀的导管在包装中储存，其中提供干燥剂袋，其具有吸收包装内的水分的能力，以避免将生物假体组织干燥超过其在生物假体心脏瓣膜中起作用的能力受损的程度。心脏瓣膜可以缝合在密封导管内或用卡扣配合连接在其上。

4. 发明授权

EP2854711B1 PRE-ASSEMBLED BIOPROSTHETIC VALVE AND SEALED CONDUIT 有权
公开(公告)号：EP2854711B1
公开(公告)日：2018-08-22
申请号：EP13801132.5
申请日：2013-06-03
申请人： Edwards Lifesciences Corporation
发明人： CAMPBELL, Louis, A. , BOBO, Donald, E., Jr. , WRIGHT, Gregory, A. , CHEUNG, Tak, G.
IPC分类号： A61F2/24 , A61M39/22 , A61F2/02 , A61L27/22 , A61L27/36 , A61F2/00 , A61F2/06 , A61L27/24
CPC分类号： A61F2/2418 , A61F2/0095 , A61F2/06 , A61F2/2409 , A61F2/2412 , A61F2/2415 , A61F2/2427 , A61F2210/0004 , A61F2220/0075 , A61F2310/00371 , A61F2310/00383 , A61L27/222 , A61L27/24 , A61L27/3625 , A61L27/3687 , A61L27/507 , A61L2430/20 , A61L2430/40
摘要： 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.

5. 发明公开

EP2854711A1 PRE-ASSEMBLED BIOPROSTHETIC VALVE AND SEALED CONDUIT 有权
标题翻译：预组装的生物瓣膜和密封导管
公开(公告)号：EP2854711A1
公开(公告)日：2015-04-08
申请号：EP13801132.5
申请日：2013-06-03
申请人： Edwards Lifesciences Corporation
发明人： CAMPBELL, Louis, A. , BOBO, Donald, E., Jr. , WRIGHT, Gregory, A. , CHEUNG, Tak, G.
IPC分类号： A61F2/24 , A61M39/22 , A61F2/02
CPC分类号： A61F2/2418 , A61F2/0095 , A61F2/06 , A61F2/2409 , A61F2/2412 , A61F2/2415 , A61F2/2427 , A61F2210/0004 , A61F2220/0075 , A61F2310/00371 , A61F2310/00383 , A61L27/222 , A61L27/24 , A61L27/3625 , A61L27/3687 , A61L27/507 , A61L2430/20 , A61L2430/40
摘要： 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.
摘要翻译：包括诸如心脏瓣膜的生物假体瓣膜的带阀导管以及用生物可吸收材料密封的管状导管。生物假体心脏瓣膜包括已经被处理的假体组织，使得组织可以被长期储存干燥而不降低瓣膜的功能。生物假体心脏瓣膜可具有单独的牛心包小叶或全猪瓣膜。密封导管包括浸渍有生物可吸收介质如明胶或胶原的管状基质。带有阀门的导管干燥存放在包装中，其中供应有干燥剂袋，其具有吸收包装内的水分的能力，从而避免将生物假体组织干燥超过其在生物假体心脏瓣膜中起作用的能力受损的点。心脏瓣膜可以缝合在密封导管内或通过搭扣配合连接与其连接。

6. 发明授权

EP2549957B1 METHODS OF CONDITIONING SHEET BIOPROSTHETIC TISSUE 有权
公开(公告)号：EP2549957B1
公开(公告)日：2019-01-30
申请号：EP11760162.5
申请日：2011-03-23
申请人： Edwards Lifesciences Corporation
发明人： DOVE, Jeffrey, S. , TIAN, Bin , SCHNEIDER, Ralph , COHEN, Jeffrey, S. , JANKOVIC, Ivan , MIGLIAZZA, John, F. , WRIGHT, Gregory, A. , YOUNG, James, M. , CAMPBELL, Louis, A.
IPC分类号： A61F2/24 , A61L27/36 , A61L27/50

7. 发明公开

EP2549957A2 METHODS OF CONDITIONING SHEET BIOPROSTHETIC TISSUE 有权
标题翻译：方法处理的圆盘状的生物假体组构
公开(公告)号：EP2549957A2
公开(公告)日：2013-01-30
申请号：EP11760162.5
申请日：2011-03-23
申请人： Edwards Lifesciences Corporation
发明人： DOVE, Jeffrey, S. , TIAN, Bin , SCHNEIDER, Ralph , COHEN, Jeffrey, S. , JANKOVIC, Ivan , MIGLIAZZA, John, F. , WRIGHT, Gregory, A. , YOUNG, James, M. , CAMPBELL, Louis, A.
IPC分类号： A61F2/24 , A61L27/38 , D06M10/00 , D06M10/04
CPC分类号： A61F2/2415 , A61B18/20 , A61F2/02 , A61F2/24 , A61F2/2409 , A61F2/2418 , A61F2002/30324 , A61F2250/0036 , A61L27/3604 , A61L27/3625 , A61L27/3691 , A61L27/507 , A61L2300/60 , A61L2430/20 , B65B55/18 , B65B63/02
摘要： Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes. The finally thinned membrane may then be treated by capping of calcification nucleation sites and borohydride reduction. The leaflets may be formed to have more than one region of uniform thickness, such as a thicker peripheral sewing region.

8. 发明公开

EP2651338A2 PROSTHETIC HEART VALVE DELIVERY SYSTEMS AND PACKAGING 有权
标题翻译： FREISETZUNGSSYSTEMEFÜRHERZKLAPPENPROTHESE UND VERPACKUNG
公开(公告)号：EP2651338A2
公开(公告)日：2013-10-23
申请号：EP11849874.0
申请日：2011-12-15
申请人： Edwards Lifesciences Corporation
发明人： GAUTAM, Abhishek , WRIGHT, Gregory, A.
IPC分类号： A61F2/24 , A61M39/22 , A61F2/76
CPC分类号： B65B55/18 , A61F2/0095 , A61F2/2412 , A61F2/2415 , A61F2/2418 , A61F2/2427 , A61F2/2433 , A61F2250/0036
摘要： 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.
摘要翻译：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也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。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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