PROSTHETIC HEART VALVE DELIVERY SYSTEMS AND PACKAGING
    1.
    发明申请
    PROSTHETIC HEART VALVE DELIVERY SYSTEMS AND PACKAGING 有权
    先天性心脏瓣膜输送系统和包装

    公开(公告)号:US20120158128A1

    公开(公告)日:2012-06-21

    申请号:US13324124

    申请日:2011-12-13

    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, 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.

    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内,然后将组件灭菌。 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。

    CAPPING BIOPROSTHETIC TISSUE TO REDUCE CALCIFICATION
    2.
    发明申请
    CAPPING BIOPROSTHETIC TISSUE TO REDUCE CALCIFICATION 有权
    CAPPING BIOPROSTHETIC TISSUE减少计算

    公开(公告)号:US20110165675A1

    公开(公告)日:2011-07-07

    申请号:US12777994

    申请日:2010-05-11

    Abstract: A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.

    Abstract translation: 用于植入物或组装的生物假体心脏瓣膜中用于减少体内钙化的生物假体组织的治疗。 该方法包括将钙化缓解剂如封端剂或抗氧化剂施用于组织以特异性抑制组织中的氧化。 此外,该方法可用于抑制脱水组织中的氧化。 封端剂抑制由氧化暴露或产生的组织中的结合位点的形成,否则在植入时会吸引钙,磷酸盐,免疫原性因子或钙化的其它前体。 在一种方法中,组装的生物假体心脏瓣膜中的组织小叶在脱水和灭菌之前用醛封端剂预处理。

    METHODS OF CONDITIONING SHEET BIOPROSTHETIC TISSUE
    6.
    发明申请
    METHODS OF CONDITIONING SHEET BIOPROSTHETIC TISSUE 有权
    调节片生物组织的方法

    公开(公告)号:US20110238167A1

    公开(公告)日:2011-09-29

    申请号:US13069827

    申请日:2011-03-23

    Abstract: 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.

    Abstract translation: 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。

    Prosthetic heart valve delivery systems and packaging
    8.
    发明授权
    Prosthetic heart valve delivery systems and packaging 有权
    假性心脏瓣膜输送系统和包装

    公开(公告)号:US09498317B2

    公开(公告)日:2016-11-22

    申请号:US13324124

    申请日:2011-12-13

    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, 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.

    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内,然后将组件灭菌。 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。

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