CN103313734B - 具有高塑性和高刚性的双ePTFE层系统的支架移植物 - Google Patents

具有高塑性和高刚性的双ePTFE层系统的支架移植物 Download PDF

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CN103313734B
CN103313734B CN201180064191.2A CN201180064191A CN103313734B CN 103313734 B CN103313734 B CN 103313734B CN 201180064191 A CN201180064191 A CN 201180064191A CN 103313734 B CN103313734 B CN 103313734B
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rete
eptfe
tube element
blood vessel
graft
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CN103313734A (zh
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R·布利古拉
G·斯托克特
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Abbott Cardiovascular Systems Inc
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Abstract

公开了血管假体和方法，其包括具有格架结构的第一柔性支架，所述格架结构具有压缩构造和扩张构造；在第一柔性支架内的第二柔性支架，以形成管状结构；移植物材料诸如扩张的聚四氟乙烯的第一膜层，其夹在第一和第二柔性支架之间；以及扩张的聚四氟乙烯的第二膜层，其夹在第一和第二柔性支架之间，所述第二层具有比第一层更高的刚性和更低的塑性。

Description

具有高塑性和高刚性的双ePTFE层系统的支架移植物
背景
本发明一般涉及可植入假体，其用于修复或置换体腔。更具体而言，本发明涉及腔内假体或支架移植物，其具有至少两个ePTFE层，该层夹在第一和第二支架之间，其中一个ePTFE层具有较高的塑性而一个层具有较高的刚性，以降低对孔形成的灵敏性。
发明背景
腔内假体是用于通过修复、置换或支撑组织来治疗患病或堵塞的血管和其它体腔的医疗装置。假体可用于治疗多种疾病和损伤，诸如血管狭窄、血栓形成、堵塞和动脉瘤。用于修复各种身体血管中的疾病的一种类型的腔内假体是支架。支架通常是由生物相容材料形成的纵向管状装置，其用于打开和支撑身体中的各种腔。血管内支架已被广泛用于治疗各种血管中的狭窄、缩窄和动脉瘤。这些装置被植入到血管中，以保持血管的塌陷或部分堵塞部分打开或使其加固。
支架通常包括可收缩的柔性格架结构，其由金属材料形成。该结构使得支架放射状地压缩于导管上，例如用于腔内植入。当邻近受损血管被适当布置后，支架放射状地扩张，以支撑和加强血管，使得血液流动经过支架的管状构造。支架的放射状扩张可通过作为部分导管的膨胀球囊的外向压力来完成，或者支架可以是自扩张种类，诸如由镍钛金属互化物构造的那些，其可被装入保护套中并随着套被移开而放射状地扩张。
移植物是另一类型的腔内假体，其用于修复和置换各种身体血管。支架提供结构支撑以保持受损血管打开，而移植物提供人造腔。移植物是管状装置，其可由各种材料形成，包括纺织品和非纺织品材料。特别适合用作可植入假体的一种类型的非纺织品材料是聚四氟乙烯(PTFE)。PTFE显示优良的生物相容性和低凝血酶原性，这使其作为血管移植物材料在血管的修复或置换中尤其有用。在血管应用中，一些移植物由扩张的PTFE(ePTFE)管制成。这些管具有多微孔结构，其在植入到血管系统后允许天然组织生长和细胞内皮化(endothelization)。这有助于长期愈合和移植物通畅。
支架和移植物可形成支架-移植物内用假体，以组合每一单独装置的特征和优势。例如，已经在支架的内和/或外表面上提供管状覆盖物，以形成一种类型的支架-移植物。常常期望在支架-移植物内用假体中结合薄壁移植物，以最小化内用假体的外形和最大化通过内用假体的血流量。
ePTFE片材或膜常常结合支架被使用。例如Myers等的美国专利号5,700,285和5,735,892描述了ePTFE片材在支架上重叠，以形成管状移植物。该移植物通过应用热塑性粘合剂和融化粘合剂的热处理而固定于支架。在片材重叠之处形成的接缝也通过使用热塑性粘合剂被密封。Martin等的美国专利号6,361,637描述了通过波状支架线材的螺旋状缠绕物固定或交织ePTFE移植物条。ePTFE条与波状线材的顶点间隔开，以便没有条完全覆盖波状线材的缠绕物。通过使用热塑性粘合剂和应用热将移植物条固定到支架线材。
Parodi的美国专利号6,344,054描述了支架移植物，其移植物仅被固定到支架的一端。通过仅将移植物的一端固定到支架，这样的移植物避免了在支架收缩和扩张期间置于移植物上的不适当的应力。Kujawski的美国专利申请公开号2003/0220682描述了混合编织支架，其具有多个重叠的移植物区段。移植物区段被描述为是纺织品移植物区段，由例如编织纱制成。移植物区段的一端被固定到支架，而移植物区段的另一端与邻近固定的移植物区段重叠。
此外，ePTFE表面已经被改性，以改变多孔性。例如，Kowligi等的美国专利号5,466,509描述了更多孔的ePTFE，其通过将图案压印到挤出的PTFE中，然后使PTFE扩张而获得。图案被描述为通过在辊之间滚花或滚压PTFE片材的片而被压印，所述辊具有在辊表面上形成的图案。具有粗糙图案的辊被描述为相比于较精细的图案产生较宽的ePTFE节间距离分布，从而增加ePTFE材料的多孔性。
Zukowski的美国专利号5,462,781描述了可植入多孔扩张聚四氟乙烯材料，其具有通过纤丝相互连接的节点的微结构，其中，其表面已经通过去除纤丝而被改性，以便在放大倍率下表面具有这样的外观：独立的节点部分不通过纤丝相互连接，而是具有在独立的节点部分之间布置的开放谷。表面下面的未改性材料被描述为维持通过纤丝相互连接的节点的初始微结构。改性被描述为通过将表面暴露于经反应性蚀刻气体进行的射频气体等离子体放电而完成。改性的表面被描述为具有增加的疏水性。这样的改性表面被描述为具有改进的血液接触性质和组织生长特点，其作为可植入装置，诸如乳房假体是有用的。
扩张的聚四氟乙烯支架移植物通常遭受塑性变形，尤其在压缩支架-移植物以载入到递送系统中、递送支架-移植物通过高度曲折的体腔和在目标植入部位放置/部署期间时。这样的塑性变形可导致ePTFE撕裂或刺破，使支架-移植物内用假体易于渗漏经过其中的血液。此外，扩张的聚四氟乙烯移植物的塑性变形可导致移植物的物理缺陷，诸如弯曲，这也是不期望的，因为其会导致差的血流模式。当使支架移植物卷曲在球囊上进行递送时，尤其容易发生撕裂或刺破，在这种情况下，没有办法确定移植物是否完好无损，导致撕裂或刺破的移植物可能阻碍整体装置性能的可能性。该问题由于变得越来越小的支架几何形状而加剧，导致ePTFE层在卷曲和嵌入过程中在细支柱之间被过分挤压。即，在ePTFE膜或箔上的高点负荷可直接导致刺破。本发明认识到该问题，并通过新方案解决该问题，以克服在支架移植物刺破情况下的渗漏。
发明内容
本发明通过利用ePTFE移植材料的两层系统——夹在内和外支架结构之间——解决上述问题。一个ePTFE层或管提供较高的塑性和第二层提供较高的刚性。不同层的顺序可以是采用高塑性层作为内层和采用高刚性层作为外层，或者反之亦然。一个高塑性和一个高刚性的层系统提供对移植物中孔形成的增强的抗性。此外，随着两个ePTFE管在部署后扩张，处于压缩构造时最初在层中同时发生的任何小孔将在管扩张后相对于彼此而占据两个不同的圆周位置。两个层的这种相对运动将有助于自密封在卷曲过程中形成的任意小孔。
附图简介
图1是本发明球囊导管的部分中的部分立视图；
图2是图1球囊导管沿线2-2的横剖面图；
图3图1球囊导管沿线3-3的横剖面图；
图4是其上安装血管支架的图1球囊导管的放大图；
图5是在去除球囊后布置在患者血管中的图4支架的放大图；
图6是支架移植物的放大侧视图，其图解由于卷曲而形成的孔；
图7是图6支架移植物的剖面图；
图8是扩张后图6支架移植物的放大侧视图，部分为阴影，图解两个孔的相对移动；和
图9是图8支架移植物的剖面图。
优选实施方式的详细描述
图1显示球囊导管，其可用于阐述本发明的特征。本发明导管10一般包括细长的导管轴11，其具有近端部分12、远端部分13、导管轴11远端部分13上的可膨胀球囊14和安装在轴11近端部分12上的适配器17。在图1中，导管10被示例位于患者体腔18的大的放大图中，这是在球囊14膨胀之前。
导管轴11具有外管状元件19和内管状元件20，该内管状元件20布置在外管状元件内并与外管状元件限定膨胀腔21。膨胀腔21与可膨胀球囊14的内部室15流体连通。内管状元件20具有在其中延伸的内腔22，其被配置成可滑动地接纳适于推进通过患者冠状动脉的引导丝23。可膨胀球囊14的远极端密封地固定于内管状元件20的远极端，并且，球囊的近极端密封地固定于外管状元件19的远极端。
图2和3分别显示导管轴11和球囊14的横剖面，其图解引导丝的内管状元件20的引导丝接纳腔22和通向球囊内部15的膨胀腔21。球囊14可通过流体诸如空气、盐水或在侧臂25中的端口被引入到包含在导管轴11中的膨胀腔21的其它流体而膨胀，或通过其它手段，诸如从导管轴11外面和形成球囊14的元件之间形成的通道而膨胀，这取决于导管的具体设计。使球囊膨胀的方式的细节和机械学根据导管的具体设计而不同，并且在本发明的论述中被省略。
在植入支架移植物16的典型程序中，引导丝23通过熟知的方法推进通过患者的血管系统，以便引导丝的远端推进经过支架布置在体腔18中的位置。在植入支架移植物16之前，心脏病学家可能希望进行血管成形术程序或其它程序(即，动脉粥样硬化切除术（atherectomy）)，以打开血管和重塑患病区域。此后，支架移植物递送导管组合件10在引导丝23上推进，以便支架移植物16布置在目标区域。球囊14被膨胀，以便其向外放射状地扩张，并且进而使支架移植物16向外放射状地扩张，直到支架移植物16支撑在体腔18的血管壁上。然后，使球囊14放气，并且导管从患者的血管系统收回，留下支架移植物16在适当的位置，以使体腔扩大。对于任何扩张后程序，引导丝23通常被留在体腔内，并随后从患者的血管系统中收回。如图4所描述的，使球囊14充分膨胀，同时支架移植物16扩张并压在血管壁上，并且，在图5中，植入的支架移植物16在球囊被放气和导管组合件和引导丝从患者中收回后留在血管中。如上所述，还存在自扩张假体，其中支架由形状记忆材料诸如镍钛金属互化物形成，该自扩张假体被形成以便在不受约束的环境中呈现扩张构造。为了植入该类型的装置，使用鞘替换球囊，以在装置被递送到体腔时约束支架。当装置被适当放置后，鞘被收回，使得支架紧靠血管壁扩张并呈现其在血管中的位置。本发明意图同时包括自扩张假体以及通过机械或其它手段扩张的假体。
本发明的支架移植物16利用两层ePTFE，其夹在内支架40和外支架42之间。一层ePTFE材料被形成，以便具有高塑性，使其对刺破更具抗性，并且，第二层ePTFE被形成，以具有高刚性，以加强支架移植物。相比于其它支架移植物，两个层46、48发挥作用，以提供柔性和强度的更好平衡。层46、48对于避免刺破也提供更好的保护，这是由于两种材料之间的差异。另外，两层将不同地扩张，如果在支架移植物中发生刺破，这将减轻刺破的作用，如下所述。
产生支架移植物的程序是将具有高塑性的ePTFE的管48放置在具有高刚性的ePTFE的第二管46之上(这两个层的顺序也可以颠倒)，以产生ePTFE箔的双层管(见图7)。然后，ePTFE膜或箔的两个层被放置在内支架元件40的外部上。然后，外支架42被放置在双ePTFE层上，以将双ePTFE层夹在内和外支架之间。如本领域中悉知的，内和外支架诸如在末端被焊接在一起，以将ePTFE层46、48夹在其间。然后，该支架移植物16被安装到球囊导管上，如图1所示的那样，以在患者中部署。
图6图解支架移植物16处于其压缩状态——如在球囊上将被发现的——的放大图，其中球囊被省略。显示将在球囊上表现出卷曲时的图6的支架移植物16，并且，图7是图6支架移植物16的剖面图，其显示孔91a、b，分别在每一ePTFE层中对齐和同时发生，还经过内和外支架壁。这类似于如果在将支架移植物固定到球囊的卷曲过程中存在刺破将会发生的。在卷曲过程、焊接过程、或在处理或制造过程中可能发生孔91a、b。当处于卷曲状态时，孔经过两个ePTFE层46、48，并被对齐，以便它们看起来如同一个孔。在没有本发明的两层ePTFE的情况下，当扩张时，这些孔91a、b会呈现出渗血的风险或支架移植物的其它结构缺陷。
图8描述扩张后同样的支架移植物，并且，图9显示扩张的支架移植物的剖面。当支架移植物16扩张时，如例如通过球囊或自扩张镍钛金属互化物支架构造，本发明的内和外ePTFE层(分别为46、48)以稍不同的几何形状扩张，这是由于其材料性质的差异。结果，最初对齐的孔91a、b现在不对齐，以便没有重叠，并且，每一层均阻挡邻近层的孔。也就是说，当与内层46的孔91b相比时，外层48的孔91a移动到不同的圆周位置，其最佳示于图9中。孔91a、b的这种不对齐提供保护，免于从在卷曲过程中形成的孔渗漏，并且，如果发生孔，起作用以自密封支架移植物。
两个ePTFE层的相对运动提供对渗漏的防御，并且还有助于支架移植物的总体完整性。即，在一个层具有缺陷的情况下或如果一个层在制造过程中被刺破时，两个层提供相互支持。利用不同的烧结工艺，可以调节和操作ePTFE材料的性质。例如，具有较高刚性的层可以比具有较高塑性的层高的水平被烧结，具有较高塑性的层以较低水平被烧结。其它制造工艺可用于改变ePTFE膜的性质，以便一个层将具有较高的刚性和一个层可具有较高的塑性。
虽然已经示出和描述了本发明的具体形式，但可以对本发明进行各种修饰而不背离本发明的精神和范围，这对本领域的技术人员来说是显而易见的。因此，除了所附权利要求书之外，不意图使本发明受到限制。

Claims (7)

1.血管假体，包括：
第一柔性支架，其具有格架结构，所述格架结构具有压缩构造和扩张构造；
第二柔性支架，其在所述第一柔性支架内，以形成管状结构，所述第二柔性支架具有格架结构，所述格架结构具有压缩构造和扩张构造；
扩张的聚四氟乙烯的第一膜层，其夹在所述第一和第二柔性支架之间；和
扩张的聚四氟乙烯的第二膜层，其夹在所述第一和第二柔性支架之间并且与所述第一膜层直接接触，所述第二层比所述第一层具有更高的刚性和更低的塑性，其中，当所述第一、第二支架从所述压缩构造移动到所述扩张构造时，所述第一膜层相对于所述第二膜层可圆周地移动。
2.权利要求1所述的血管假体，其中所述第一膜层以较所述第二膜层低的水平被烧结。
3.权利要求1所述的血管假体，其中，当所述第一和第二柔性支架扩张至其扩张构造时，所述第一膜层扩张到与所述第二膜层的圆周位置不同的圆周位置。
4.制造血管假体的方法，包括：
提供第一可扩张的管状支架；
通过将ePTFE的第一管状元件施加到心轴上，然后将ePTFE的第二管状元件施加到所述第一管状元件上并且与所述第一管状元件直接接触而形成多层移植物元件，所述第一管状元件相对于所述第二管状元件可圆周地移动，其中，所述ePTFE的第二管状元件具有不同于所述第一管状元件的刚性和塑性；
将所述多层移植物元件放置于所述第一可扩张的管状支架上；
将第二可扩张的管状支架放置于所述多层移植物元件上，以将多层管状移物植元件夹在所述第一和第二支架之间；和
将所述第一可扩张的管状支架固定于所述第二可扩张的管状支架。
5.权利要求4所述的制造血管假体的方法，还包括以不同于所述ePTFE的第二管状元件的烧结水平形成所述ePTFE的第一管状元件的步骤。
6.权利要求4所述的制造血管假体的方法，还包括所述由形状记忆材料形成所述第一和第二管状支架的步骤。
7.权利要求4所述的方法，其中所述血管假体适于卷曲在导管球囊上。
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Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2194921B1 (en) 2007-10-04 2018-08-29 TriVascular, Inc. Modular vascular graft for low profile percutaneous delivery
US10028747B2 (en) 2008-05-01 2018-07-24 Aneuclose Llc Coils with a series of proximally-and-distally-connected loops for occluding a cerebral aneurysm
US10716573B2 (en) 2008-05-01 2020-07-21 Aneuclose Janjua aneurysm net with a resilient neck-bridging portion for occluding a cerebral aneurysm
US9358140B1 (en) 2009-11-18 2016-06-07 Aneuclose Llc Stent with outer member to embolize an aneurysm
EP3417889A1 (en) 2009-12-13 2018-12-26 Amit Prakash Govil Bioactive grafts and composites
US8992595B2 (en) 2012-04-04 2015-03-31 Trivascular, Inc. Durable stent graft with tapered struts and stable delivery methods and devices
US9681951B2 (en) 2013-03-14 2017-06-20 Edwards Lifesciences Cardiaq Llc Prosthesis with outer skirt and anchors
US9539286B2 (en) 2013-10-18 2017-01-10 Globus Medical, Inc. Bone grafts including osteogenic stem cells, and methods relating to the same
US9486483B2 (en) 2013-10-18 2016-11-08 Globus Medical, Inc. Bone grafts including osteogenic stem cells, and methods relating to the same
US9579421B2 (en) * 2014-02-07 2017-02-28 Globus Medical Inc. Bone grafts and methods of making and using bone grafts
CN104939947A (zh) * 2014-03-26 2015-09-30 上海市第六人民医院 一种具有内皮祖细胞捕获功能的脑覆膜支架
CN104490502A (zh) * 2014-12-25 2015-04-08 周玉杰 一种用于治疗冠脉穿孔的生物可吸收膜覆膜支架
US9788950B1 (en) * 2016-04-22 2017-10-17 Vivex Biomedical, Inc. Cohesive bone composition
US10596298B2 (en) 2016-04-22 2020-03-24 Vivex Biologics Group, Inc. Malleable demineralized bone composition and method of manufacture
US10463767B2 (en) 2016-04-22 2019-11-05 Vivex Biologics Group, Inc. Moldable bone composition
US11253630B2 (en) 2016-04-22 2022-02-22 Vivex Biologics Group, Inc. Malleable demineralized bone composition and method of manufacture
US11253629B2 (en) 2016-04-22 2022-02-22 Vivex Biologics Group, Inc. Bone gel sheet composition and method of manufacture
KR20190038833A (ko) * 2016-07-11 2019-04-09 보누스 테라퓨틱스 리미티드 조직 재생용 세포 조성물
CN106175987A (zh) * 2016-08-31 2016-12-07 上海纽脉医疗科技有限公司 人工心脏瓣膜
US10743996B2 (en) 2017-03-24 2020-08-18 Robert L. Bundy Amnion putty for cartilage repair
CN108836584A (zh) * 2018-05-28 2018-11-20 上海长海医院 一种分段式复合密网结构颈动脉支架
CN108836585B (zh) * 2018-05-28 2021-07-30 上海长海医院 一种带可吸收自突膜分支的y型颈动脉支架
CN109277773B (zh) * 2018-10-22 2019-11-08 沈阳兴华航空电器有限责任公司 一种屏蔽软管组件的封接装配方法
CN109675104B (zh) * 2019-01-09 2020-08-14 四川大学 矿化水凝胶及仿生矿化骨修复材料的制备方法
US11207445B2 (en) * 2019-07-09 2021-12-28 Community Blood Center Allograft bone putty and methods of making the same
US11896736B2 (en) 2020-07-13 2024-02-13 Globus Medical, Inc Biomaterial implants and methods of making the same
CN117357316B (zh) * 2023-12-06 2024-02-20 苏州美创医疗科技有限公司 一种覆膜支架及其制造方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5916264A (en) * 1997-05-14 1999-06-29 Jomed Implantate Gmbh Stent graft
CN1228690A (zh) * 1996-07-03 1999-09-15 巴克斯特国际有限公司 具有固定模的可径向膨胀的管状ptfe移植物

Family Cites Families (54)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2028935A (en) * 1932-06-06 1936-01-28 William V Knell Gelatin and glue extractor
US3892876A (en) 1971-11-30 1975-07-01 Leiner & Sons Wales Limited P Process of preparing freeze-dried gelatin
US4294753A (en) * 1980-08-04 1981-10-13 The Regents Of The University Of California Bone morphogenetic protein process
US4455256A (en) * 1981-05-05 1984-06-19 The Regents Of The University Of California Bone morphogenetic protein
US5356630A (en) 1989-02-22 1994-10-18 Massachusetts Institute Of Technology Delivery system for controlled release of bioactive factors
US5073373A (en) 1989-09-21 1991-12-17 Osteotech, Inc. Flowable demineralized bone powder composition and its use in bone repair
US5236456A (en) * 1989-11-09 1993-08-17 Osteotech, Inc. Osteogenic composition and implant containing same
FR2654625B1 (fr) 1989-11-22 1992-02-21 Transphyto Sa Procede de fabrication d'un materiau pour osteoplastie a partir d'un tissu osseux naturel et materiau obtenu par ce procede.
US5231169A (en) 1990-10-17 1993-07-27 Norian Corporation Mineralized collagen
US5217666A (en) * 1991-05-29 1993-06-08 Daikin Industries Ltd. Process for producing porous polytetrafluoroethylene film
US5462781A (en) 1991-06-14 1995-10-31 W. L. Gore & Associates, Inc. Surface modified porous expanded polytetrafluoroethylene and process for making
DE69132973T2 (de) 1991-12-30 2002-11-21 Norian Corp Mineralisiertes kollagen
US5466509A (en) 1993-01-15 1995-11-14 Impra, Inc. Textured, porous, expanded PTFE
JP2970320B2 (ja) 1993-06-07 1999-11-02 住友電気工業株式会社 人工血管
US6027779A (en) * 1993-08-18 2000-02-22 W. L. Gore & Associates, Inc. Thin-wall polytetrafluoroethylene tube
US5735892A (en) 1993-08-18 1998-04-07 W. L. Gore & Associates, Inc. Intraluminal stent graft
US5707962A (en) * 1994-09-28 1998-01-13 Gensci Regeneration Sciences Inc. Compositions with enhanced osteogenic potential, method for making the same and therapeutic uses thereof
US5667523A (en) 1995-04-28 1997-09-16 Impra, Inc. Dual supported intraluminal graft
US5628788A (en) * 1995-11-07 1997-05-13 Corvita Corporation Self-expanding endoluminal stent-graft
US6042605A (en) 1995-12-14 2000-03-28 Gore Enterprose Holdings, Inc. Kink resistant stent-graft
US6428571B1 (en) * 1996-01-22 2002-08-06 Scimed Life Systems, Inc. Self-sealing PTFE vascular graft and manufacturing methods
US5954764A (en) 1996-09-20 1999-09-21 Parodi; Juan Carlos Device for concurrently placing an endovascular expander with an endovascular prosthesis
US20020098222A1 (en) 1997-03-13 2002-07-25 John F. Wironen Bone paste
US5972368A (en) 1997-06-11 1999-10-26 Sdgi Holdings, Inc. Bone graft composites and spacers
US6309659B1 (en) 1997-09-02 2001-10-30 Gensci Orthobiologics, Inc. Reverse phase connective tissue repair composition
JPH1180005A (ja) * 1997-09-12 1999-03-23 Nippon Zoki Pharmaceut Co Ltd 骨粗鬆症治療剤
US20030180263A1 (en) 2002-02-21 2003-09-25 Peter Geistlich Resorbable extracellular matrix for reconstruction of bone
US6090998A (en) * 1997-10-27 2000-07-18 University Of Florida Segmentally demineralized bone implant
US5931865A (en) * 1997-11-24 1999-08-03 Gore Enterprise Holdings, Inc. Multiple-layered leak resistant tube
US5899939A (en) * 1998-01-21 1999-05-04 Osteotech, Inc. Bone-derived implant for load-supporting applications
US20020018796A1 (en) * 1998-01-28 2002-02-14 John F. Wironen Thermally sterilized bone paste
US20020076429A1 (en) 1998-01-28 2002-06-20 John F. Wironen Bone paste subjected to irradiative and thermal treatment
US6123731A (en) * 1998-02-06 2000-09-26 Osteotech, Inc. Osteoimplant and method for its manufacture
US6911212B2 (en) 1998-02-27 2005-06-28 Musculoskeletal Transplant Foundation Malleable putty and flowable paste with allograft bone having residual calcium for filling bone defects
WO1999047077A1 (en) 1998-03-18 1999-09-23 Meadox Medicals, Inc. Improved ptfe vascular prosthesis and method of manufacture
US6099559A (en) * 1998-05-28 2000-08-08 Medtronic Ave, Inc. Endoluminal support assembly with capped ends
US6652570B2 (en) * 1999-07-02 2003-11-25 Scimed Life Systems, Inc. Composite vascular graft
CN1130984C (zh) 2000-06-20 2003-12-17 张勤成 一种营养快餐
DE10029520A1 (de) 2000-06-21 2002-01-17 Merck Patent Gmbh Beschichtung für metallische Implantatmaterialien
US6575249B2 (en) 2001-05-17 2003-06-10 Thomas Michael Deaton Apparatus and method for locking open a flow control device
US7132110B2 (en) * 2001-08-30 2006-11-07 Isotis Orthobiologics, Inc. Tissue repair compositions and methods for their manufacture and use
US7371409B2 (en) * 2001-09-06 2008-05-13 Wright Medical Technology, Inc. Bone graft substitute composition
WO2003030956A2 (en) * 2001-10-12 2003-04-17 Osteotech, Inc. Improved bone graft
US7083822B2 (en) * 2002-04-26 2006-08-01 Medtronic Vascular, Inc. Overlapping coated stents
US7887575B2 (en) 2002-05-22 2011-02-15 Boston Scientific Scimed, Inc. Stent with segmented graft
US6652887B1 (en) 2002-06-24 2003-11-25 Wright Medical Technology, Inc. Bone graft substitute composition
US7582309B2 (en) 2002-11-15 2009-09-01 Etex Corporation Cohesive demineralized bone compositions
ATE377398T1 (de) * 2002-11-22 2007-11-15 Cook Inc Stentgefässtransplantat
CN1305449C (zh) * 2003-12-25 2007-03-21 傅剑华 改进的医用腔内支架
US7497872B2 (en) * 2004-03-08 2009-03-03 Cook Incorporated Retainer for a stent-graft
US8945223B2 (en) 2004-03-12 2015-02-03 Warsaw Orthopedic, Inc. In-situ formable nucleus pulposus implant with water absorption and swelling capability
US7749268B2 (en) 2004-05-26 2010-07-06 Warsaw Orthopedic, Inc. Methods for treating the spine
US7785634B2 (en) 2006-02-27 2010-08-31 Globus Medical, Inc. Bone graft materials derived from mineralized gelatin
US7892577B2 (en) * 2006-02-27 2011-02-22 Globus Medical, Inc. Bone graft materials derived from mineralized gelatin

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1228690A (zh) * 1996-07-03 1999-09-15 巴克斯特国际有限公司 具有固定模的可径向膨胀的管状ptfe移植物
US5916264A (en) * 1997-05-14 1999-06-29 Jomed Implantate Gmbh Stent graft

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