CN102413794B - 用于在手术部位部署腔内假体的系统和方法 - Google Patents

用于在手术部位部署腔内假体的系统和方法 Download PDF

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CN102413794B
CN102413794B CN201080017957.7A CN201080017957A CN102413794B CN 102413794 B CN102413794 B CN 102413794B CN 201080017957 A CN201080017957 A CN 201080017957A CN 102413794 B CN102413794 B CN 102413794B
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stent graft
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S·亚贝弗伊尔
F·克里斯蒂安
J·A·小曼古诺
J·C·坎宁
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Bolton Medical Inc
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

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Abstract

一种用于植入假体的系统(10)包括控制腔(12)和固定在控制腔的远端的鼻锥(18)。至少有一个支撑线(22，23)在一端固定，大致平行于控制腔的主轴线，并在相对端处是自由的，其中至少一个支撑线的自由端(26，27)是弓形的。替代地，用于植入假体的系统包括从固定到控制腔的远端的鼻锥延伸的至少一个缝合线(130)。缝合线从鼻锥延伸到围绕控制腔延伸的支架移植物(128)的近端，并从支架移植物延伸到控制腔上的固定位置。缝合线能够通过远程致动从支架移植物释放，由此缝合线从鼻锥分开，由此部署支架移植物。

Description

用于在手术部位部署腔内假体的系统和方法
相关申请
本申请要求2009年3月13日提交的美国临时申请No.61/160052以及2009年10月27日提交的美国临时申请No.61/255339的优先权。这些临时申请的教导通过引用整体结合于此。
背景技术
用于治疗动脉疾病的腔内假体多年来已被广泛应用。通常，这种假体含有通过自膨胀支架支承的梭织聚对苯二甲酸乙酯(PET)的腔移植材料，该支架通常由形状记忆合金形成。
腔内支架移植物(这样称谓是因为它们在血管腔内部署)用来支承患病的动脉组织，例如已经薄弱而形成动脉瘤、假性动脉瘤、解剖体、穿透性溃疡和壁间血肿的动脉组织。最容易受到这些类型的疾病状态影响并能够通过植入腔内支架移植物来治疗的动脉包括例如腹主动脉、胸腹主动脉、胸降主动脉、主动脉弓和升主动脉。
一般来说，腔内假体通过经患者股动脉的股动脉入路(femoral access)来植入。可替代地，腔内器械可以通过经心尖和左心室进入例如升主动脉的经心尖入路(transapical access)来植入，并在部署时，在窦管接合部((主动脉的)主动脉窦之间的升主动脉的区域，并得到主动脉的正常结构)处基本邻靠主动脉瓣膜。
自膨胀支架移植物假体的植入通常需要在输送到患者体内部署部位的过程中被约束在窄小直径内。通常，该直径通过将假体包含在至少一个护套内来约束，该护套在相对于外科医生的远端通过柔韧的鼻锥封盖。护套和鼻锥由引导丝引导经过动脉腔，该引导丝轴向延伸经过其中含有假体的输送装置的鼻锥并从其延伸。一旦鼻锥和护套已经推进到将要部署假体的手术部位，含有假体的护套会转动(如何需要的话)，从而适当地定向假体，并且接着一个或多个护套缩回，使得假体膨胀，由此在所需治疗部位部署假体。
从约束护套远程部署腔内假体会出现多种问题。例如，如果主动脉的将要部署假体的部分具有急剧的弯曲部或者较小的曲率半径，例如弓形的主动脉的弧度，或者由于主动脉的疾病状态已经造成主动脉具有不规则的形状，则一个或多个护套从假体简单缩回会造成支架移植物的近端(在临床上相对于患者而言)不能与动脉壁适当对准。例如，支架移植物的近端的一部分会向后靠近血管弯曲部朝着外科医生转动，由此造成支架移植物的近端损坏，从而与动脉形成密封。这种现象通常称谓“翻转”。更常见的是，支架移植物近端的一部分在部署过程中在在主动脉弓(其具有相对大的直径)内部署的支架移植物的下方侧出现转动。另一问题包括形成也称为“间隙”的“鸟嘴(bird’s beak)”，这是由于支架移植物不能与主动脉的下方部分曲部适当相符而造成的，最为通常的是由于迫使将要部署的假体的最为近侧的被覆盖支架最后被部署的顺序造成的。
另一问题出现在支架移植物必须靠近升主动脉和主动脉瓣膜之间的接合部部署时。具体地，用来帮助引导腔内假体到手术部位的鼻锥限制了外科医生当接近升主动脉时在其原点处部署护套内所含的假体的能力。
因此，需要最小化或克服上述缺陷的用于植入假体的输送系统和用于植入假体的方法。
发明内容
本发明总体针对用于植入假体的系统和方法，并且具体地涉及用于在主动脉的疾病部位植入腔内假体的系统和方法。
在本发明的一种实施方式中，该系统包括控制腔、固定在控制器的远端的鼻锥以及一端固定、大致平行于控制腔的主轴线且在相对端自由的至少一个支撑线。至少一个支撑线的自由端是弓形的。
在另一实施方式中，本发明的系统包括控制腔、固定在控制腔的远端的鼻锥、围绕控制腔延伸的支架移植物以及从鼻锥延伸到支架移植物的近端并从支架移植物延伸到控制腔上的固定位置的至少一个缝合线。缝合线能够通过远程致动从支架移植物释放，由此控制腔的缩回将缝合线从鼻锥释放，由此部署支架移植物。
在本发明的又一实施方式中，该系统包括控制腔、固定在控制腔的远端的鼻锥以及在控制腔上延伸的内护套，其限定在内护套的远端处的远侧开口。鼻锥能够在内护套内缩回。
在本发明的再一实施方式中，本发明是用于植入假体的方法，其包括将支架移植物输送经过动脉到患者的动脉瘤部位，支架移植物通过内护套在径向上约束并至少部分地通过控制腔支撑。支架移植物还通过从鼻锥、从控制腔或围绕控制腔延伸并可沿着控制腔滑动的外部控制管延伸的至少一个支撑线进一步在纵向上约束，其中至少一个支撑线的自由端是弓形的，并且延伸经过支架移植物近端内的环套孔。内护套从支架移植物部分地缩回，由此支撑线至少部分地限制支架移植物的近端的纵向运动，直到支架移植物的近端固定在动脉内，由此防止支架移植物的近端的一部分在动脉的下方部分处转动。内护套和支撑线接着缩回，由此从环套移除支撑线，并且在患者的动脉瘤部位处将支架移植物部署在动脉内。内护套和支撑线可以一起缩回，由此从环套移除支撑线，并且在患者的动脉瘤部位处将支架移植物部署在动脉内。
在一种实施方式中，该方法还包括在部分地缩回内护套之后在支架移植物内缩回地鼻锥的步骤。支架移植物接着推进到动脉内的最终位置。随后，内护套、鼻锥和支撑线缩回，从而在患者的动脉瘤部位处将支架移植物完全部署在动脉内。
在本发明的另一实施方式中，该方法包括将支架移植物输送经过动脉到患者的动脉瘤部位。支架移植物通过内护套在径向上约束并至少部分地通过控制腔支撑，并且进一步通过从控制腔的远端处的鼻锥延伸到支架移植物的近端并从支架移植物的近端延伸到控制腔上的固定位置的至少一个缝合线约束。缝合线能够从鼻锥和支架移植物通过远程致动释放。内护套从支架移植物缩回，由此缝合线至少部分地限制支架移植物的近端的纵向运动，直到支架移植物的近端固定在动脉内，由此防止支架移植物的近端的一部分在动脉的下方部分处转动。接着远致动缝合线，由此缝合线从鼻锥释放，并且释放支架移植物。内护套接着缩回，由此在患者动脉瘤部位处将支架移植物部署在动脉内。
在又一实施方式中，本发明是用于植入假体的方法，假体包括控制腔、固定在控制腔远端处的鼻锥、围绕控制腔延伸并可沿着控制腔滑动的护套腔以及从护套腔向远侧延伸并在鼻锥和护套腔之间围绕控制腔的内护套，内护套限定靠近护套腔且位于内护套的近端的至少一个通孔。
在再一实施方式中，本发明是用于植入假体的系统，其包括控制腔、固定在控制腔的远端处的鼻锥、围绕控制腔延伸的外部控制管以及位于外部控制腔的远端并可沿着控制腔滑动的顶点搭扣、围绕控制腔延伸的护套腔、围绕外部控制管从护套腔向远侧延伸的内护套，内护套包括位于内护套的远端处的三角形部件；以及位于外部控制管和内护套之间的支架移植物，支架移植物包括靠近鼻锥并具有位于近端处的搭扣支架的近端，其中搭扣支架具有通过顶点搭扣可释放保持的至少一个暴露的近侧顶点。
在另一实施方式中，本发明是用于植入假体的方法，其包括如下步骤：将支架移植物输送经过动脉到患者的动脉瘤部位相对于患者的远侧的点，支架移植物通过内护套在径向上约束，并固定到外部控制管，并且其中内护套通过引入器护套约束，支架移植物和内护套各自包括位于支架移植物和内护套的上方部分的至少一个不透辐射标记，不透辐射标记沿着内护套的主纵向轴线分开；使得内护套、支架移植物和外控制腔推进超过引入器护套，直到支架移植物横跨患者的动脉瘤部位；从支架移植物部分地缩回内护套，由此支架移植物的不透辐射标记与内护套的不透辐射标记重叠；将支架移植物的近端定位在动脉内；以及完全缩回内护套，由此将支架移植物完全部署在动脉内。
本发明具有许多优点。例如，用于植入假体的系统的支撑线为支架移植物的近端的至少一部分(例如支架移植物的近端的位于主动脉弓的弯曲部的下方或内侧部分的部分)提供纵向支承。这种纵向约束限制了腔内支架的近端的一部分在主动脉弓腔的下方部分处的转动，由此造成支架移植物的近端适当座置于与延伸经过支架移植物的近端处的主动脉腔的主纵向轴线大致横向的平面内。支架移植物的近端的适当座置防止血液超过假体和在假体之下渗漏，由此增加成功植入的可能性，并延长假体植入物的使用寿命。另外，鼻锥在支架移植物部署之前在支架移植物内缩回使得假体能够部署在患者的升主动脉内，基本上与心脏瓣膜邻靠，由此在将支架移植物放置在患者体内时为外科医生提供了更大的灵活性。另外，鼻锥在支架移植物部署在患者的腹主动脉内之前在支架移植物内缩回使得支架移植物相对于腹主动脉的动脉瘤部位准确地放置，由此在将支架移植物放置在患者体内时为外科医生提供了更大的灵活性。本发明的另一优点在于限定至少一个通孔的内护套，其允许血液在支架移植物部署过程中灌注或连续流动。
附图说明
如附图所示，以上内容将从本发明的示例性实施方式的更加特别描述之后得以清楚，附图中同样的附图标记在不同视图中表示相同的部件。附图不必按照比例，相反重点在于说明本发明的实施方式。
图1表示用于在主动脉腔中植入支架移植物的现有技术系统。
图2表示现有技术中从护套将支架移植物部署在主动脉的弯曲部分的腔内，使得支架移植物的近端在下方部分处向后转动。
图3表示现有技术中完全部署支架移植物的情况，其中支架移植物的近端的翻转造成扭结。
图4表示现有技术中部署支架移植物的情况，其中由于最后释放第一近侧覆盖支架的部署顺序造成了“鸟嘴”。
图5A表示本发明用于植入假体的系统的实施方式。
图5B和5C表示本发明用于植入假体的包括顶点搭扣的系统的实施方式。
图6表示本发明用于植入假体的系统的另一实施方式。
图7A、7B和7J表示本发明用于植入假体的系统的实施方式的一部分的侧视和纵向截面图。
图7C和7K表示用于本发明用于植入假体的系统的支架移植物的实施方式。
图7D表示位于本发明所使用的移植物限定的腔内部的冠状支架和搭扣支架，其具有暴露的近侧顶点。
图7E表示搭扣支架的暴露近侧顶点与本发明的顶点搭扣的尖头接合。
图7F表示位于手术部位处并处于弓形构造的支架移植物的实施方式。
图7G、7H和7I表示本发明适用于植入假体的系统的分支支架移植物的多种实施方式。
图8表示位于支架移植物的内侧表面上的缝合线环套。
图9A和9B表示本发明用于植入假体的系统内的内护套的实施方式。
图10表示本发明用于植入假体的系统内的内护套的远端的替代实施方式。
图11A和11B表示本发明用于植入假体的系统内的内护套的其它替代实施方式。
图12A表示本发明的其中鼻锥限定鼻锥的近端处的近侧空腔的实施方式。
图12B表示本发明的其中内护套包括至少一个固定到内护套的上方部分的至少一个不透辐射标记的实施方式。
图12C表示本发明的方法的实施方式的荧光镜透视图，借此支架移植物在手术部位的部分部署通过支架移植物的至少一个不透辐射标记与内护套的至少一个不透辐射标记的对准来表示。
图13表示本发明用于植入假体的系统的实施方式，其中含有支架移植物的内护套在通过引入器护套输送之前被约束。
图14A-14E表示本发明的在在动脉瘤部位植入假体的过程中的实施方式。
图15A-15E表示在假体部署过程中本发明实施方式的不同示图。
图15B、15C 15E表示本发明的实施方式的萤光镜透视图。
图16表示本发明的系统内的内护套的实施方式。
图17和18表示本发明的用于植入假体的又一实施方式。
图19A-19D表示本发明的用于植入假体的再一实施方式。
图20A和20B表示本发明的用于通过经患者心脏的左心房的进入来植入假体的实施方式。
图21A表示本发明的包括至少一个缝合线和顶点搭扣的替代实施方式。
图21B表示本发明的包括至少一个缝合线的另一替代实施方式。
图22A和22B表示本发明的包括具有至少一个通孔的内护套的实施方式。
具体实施方式
现在将在权利要求中更加特别地描述和指出本发明的作为本发明的步骤或作为本发明的部件组合的特征和其它细节。可以理解，本发明的特定实施方式通过说明来给出，而不作为本发明的限制。本发明的主要特征可以用于多种实施方式中，而不偏离本发明的范围。
本发明总体针对用于将腔内假体植入患者的血管(例如动脉)的系统和方法。该系统和方法采用至少一个支撑线来提供纵向支承，防止腔内支架移植物的近端的一部分在支架移植物部署的过程中朝着外科医生转动。在支架移植物完全部署之前，支架移植物的近端由此适当座置在靠近动脉瘤或主动脉的其他病变部分的手术部位。
本发明还包括使得输送系统的鼻锥在支架移植物完全部署之前在腔内的支架移植物内缩回的系统，由此使得支架移植物在部署过程中邻靠例如心脏或动脉瓣膜的另一解剖结构。在又一实施方式中，腔内移植物输送系统包括位于腔内移植物一端的护套，能够从腔内移植物释放移植物，允许移植物末梢的灌注。
如图1-4所示，支架移植物1(这里也称为“腔内假体”或“假体”)在主动脉2的腔(特别是主动脉具有曲率的部分(例如主动脉弓))内从护套3的端部的部署会在假体的近端4处造成以大致纵向、朝着外科医生的方向在下方部分5向后转动，如图2所示，由此造成完全部署的假体在近端处折叠，并在假体内形成扭结6，如图4所示，或者造成支架移植物的整个近端向远侧翘曲。图4表示“鸟嘴”7的形成。“鸟嘴”的形成会在这样的假体中出现，其在假体的近端处具有裸露支架或覆盖有移植物材料的支架。
在一种实施方式中，本发明采用至少一个支撑线作为输送假体的系统部件以提供纵向支承，由此防止假体的近端4在约束护套的缩回过程中转动，由此使得假体以完全延伸的方式部署，从而基本上防止了假体的近端的下方部分的翻转以及因此造成的如图3和4所示的假体的翘曲或褶皱。翻转或这种转动以及由此造成假体的翘曲会出现在具有或不具有裸露支架的移植物中。“鸟嘴”在不具有从支架移植物的移植物部分的近端(头盖端)延伸的裸露支架的假体中尤其常见。这种支架移植物(还被称为“非裸露支架移植物”)在部署时可以用作邻靠例如心脏瓣膜的其它解剖结构的假体。在部署过程中随着约束护套的缩回，由于提供控制支架移植物的自膨胀支架膨胀的有限机会，在腔内支架移植物的近端处没有裸露支架会使得支架移植物的部署更加困难。因此，腔内支架移植物的近端的下方部分或整个部分如上所述具有在大致纵向上向后转动的趋势，由此造成不完美的密封，有可能如图3和4所示地翻转或形成“鸟嘴”。本发明的系统和方法防止了翻转和“鸟嘴”的形成。
在本发明的实施方式中，如图5A、5B、5C所示，系统10、11和13分别包括控制腔12。控制腔12通常由例如不锈钢、形状记忆合金或超弹性镍钛合金(例如镍钛诺形状记忆合金)的适当金属、例如聚醚醚酮(PEEK)的聚合物；或金属、合金或聚合物的任何组合(特别是金属和合金的组合)来形成。控制腔12通常是弓形的，并且限定延伸穿过其的腔，腔的直径例如是大约0.0040英寸(大约0.0030英寸到大约0.0050英寸)的ID(内直径)和大约0.050英寸(大约0.040英寸到大约0.060英寸)的OD(外直径)。控制腔12包括近端14和远端16。
鼻锥18被固定在控制腔12的远端16。鼻锥18由例如TECOTHANE的热塑性聚氨酯弹性体聚醚的适当材料形成。控制腔12延伸穿过鼻锥18，由此使得引导丝20从鼻锥18延伸穿过控制腔12，由此系统10、11、13可沿着引导丝20在腔内推进并经过患者的动脉(例如主动脉)到达手术部位(例如升主动脉、胸主动脉、降主动脉、腹主动脉)。
支撑线22、23在一端固定，并且大致平行于控制腔12的主轴线延伸。支撑线22、23在与固定端相对的端部处是自由端的。如图5A、5B和5C所示，支撑线22、23在近端24、25处固定，并在远端26、27处是自由的。在一种实施方式中，支撑线22、23的远端26、27是弓形的。另外，支撑线22、23包括接近近端24、25的悬臂部分28、29。通常支撑线22、23由例如不锈钢的适当手术级金属或优选为镍钛诺形状记忆合金的超弹性合金形成。支撑线22、23的长度通常在大约50毫米到大约75毫米的范围内或者在大约75毫米到大约100毫米的范围内，优选为大约75毫米。弓形端部处的线直径被减小，以确保容易变直，并保持非常柔性和无创伤的。支撑线在支架移植物的部署过程中防止图4所示的翻转。
如图5B和5C所示，外部控制管30围绕控制腔12延伸，并且能够沿着控制腔12滑动。控制腔12的适当材料的例子包括PEEK。通常，外部控制管30具有大约0.05英寸至大约0.060英寸、优选为大约0.055英寸的内直径以及具有大约0.070英寸至大约0.075英寸、优选为大约0.071英寸的外直径，由此外部控制管30的壁厚通常为大约0.007英寸至大约0.009英寸，优选为大约0.008英寸。
外部控制管30包括近端32和远端34。衬垫36例如在外部控制管30的近端32处被固定到外部控制管30。支撑线22固定在衬垫36的下方侧，由此造成支撑线22的聚集。衬垫36由例如PEEK的适当材料形成，并通常具有大约0.200英寸至大约0.300英寸、例如大约0.200英寸、大约0.225英寸、大约0.250英寸、大约0.275英寸和大约0.300英寸的外直径。衬垫36的尺寸可以设置成与引入器护套92的内直径配合。在未示出的另一实施方式中，至少一个支撑线22、23无需固定元件37被直接固定到控制腔12，并且不需要固定元件37。
推动器支承管38从衬垫36向近侧延伸。在图5C所示的另一实施方式中，线22、23通过固定元件37(其与衬垫36和推动器支承管隔开)以外部控制管30的长度被固定到控制腔12。固定元件37的适当材料的例子包括PEEK。固定元件37可以是长方形形状，从而减小附接支撑线的相对侧上的型面。
图5B和5C所示的顶点搭扣40被固定到外部控制管30的远端34，并能够沿着控制腔12通过外部控制管30的运动滑动。顶点搭扣40包括与顶点搭扣40的接收部分44形成配合关系的尖头42。通常，顶点搭扣40的尖头40由例如不锈钢的适当材料形成，而接收部分44由例如PEEK或不锈钢的适当材料形成。尖头42的尺寸设置成接收支架移植物的搭扣支架的至少一个近侧顶点(图7E)，通过尖头42从接收部分44或鼻锥18的缩回造成顶点搭扣40致动将在在手术部位部署支架移植物的过程中释放至少一个搭扣支架的暴露的近侧顶点。
任选地，顶点搭扣40可与外部控制管30分开操作，由此外部控制管30和支撑线22、23可独立于顶点搭扣40的致动缩回，如图5C所示。顶点搭扣40的分开和独立致动可通过将顶点搭扣40附接到在外部控制管30和控制腔12之间延伸的管43来获得。
在替代实施方式中，如图6所示，顶点搭扣40被附接到外部控制管30，固定元件37被附接到外部控制管30，并且支撑线22、23被附接到固定元件37，由此顶点搭扣40和支撑线22、23通过外部控制管30的致动或运动一起缩回。另外，在替代实施方式中，支撑线22、23分别包括位于远端26、27处的球根状端50、51和止挡52、53，该止挡52、53具有大于支撑线22、23的直径的直径且靠近支撑线22、23的自由远端26、27。如图7A、7B和7J所示，支架移植物60围绕系统10的控制腔12、支撑线22、23和外部控制管30延伸。内护套80围绕支架移植物60延伸，支架移植物60继而围绕推动器支承管38延伸，并且独立于推动器支承管38且可从其运动。护套腔81通常由PEBAX(聚醚嵌段胺)形成，并且可包括内部编织的不锈钢。内护套80围绕支架移植物60延伸，由此在手术部位部署之前至少部分约束支架移植物60。不透辐射标记78在离开支架移植物60的近端70大约40毫米至60毫米的范围内、例如大约40毫米、大约45毫米、大约50毫米、大约55毫米、大约60毫米的距离处固定到支架移植物60的上方侧。不透辐射标记88例如通过至少一个缝合部被固定到内护套80，并与支架移植物60的不透辐射标记78纵向对准但与其偏移。不透辐射标记88的形状可以是不对称的，例如D形，如图12B、12C和15C所示。
如图7C和7K所示，支架移植物60包括移植物62和至少一个不透辐射标记79。在一种实施方式中，不透辐射标记79是哑铃或细长形状。移植物62的适当材料的例子包括PET。通常，移植物62的PET是编织的。替代地，支架移植物60可以是具有两个长腿、一个短腿和一个长腿，和两个短腿的分支支架移植物，如图7G、7H、7L分别所示。移植物62通过通常由例如形状记忆金属或超弹性镍钛合金(例如镍钛诺形状记忆合金)的适当材料形成的支架64支承。通常，支架64被缝制到移植物62，由此支承移植物62。支架64可定位在移植物62限定的腔内(内部)或腔外。冠状支架68位于移植物62的腔内，并支承移植物62的近端70。搭扣支架72相对应患者位于冠状支架68的远侧。支架移植物还可包括至少一个未示出的钩或倒钩。
如图7D所示，搭扣支架72包括定位在移植物62限定的腔内的暴露的近侧顶点73、75。近侧顶点73、75的尺寸适用于与顶点搭扣40的尖头42接合，如图7E所示。参考图7C，纵向支承件74沿着支架移植物60的主轴线延伸，并固定到支架移植物60的外侧表面。如图7F所示，纵向支承件74位于平分支架移植物60的主纵向轴线的平面的一侧，即在支架移植物60通过系统10、11、13固定时在控制腔12的任何弯曲部的上方的一侧。同样，暴露的近侧顶点73、75位于控制腔12的弯曲部上方的一侧，并且靠近纵向支承件77的近端定位。另外，纵向支承件74相对于支架移植物60的主纵向轴线是大致反镜像对称的。支架移植物60的与包括纵向支承件74相对的第二侧没有纵向支承件。位于支架移植物60的上方部分的纵向支承件74可帮助防止由于支架移植物62符合动脉瘤的手术部位(部署支架移植物60)处的主动脉曲率而使得上方部分塌缩。
通常，纵向支承件74是弯曲的。回来参考图7C，纵向支承件74具有平行于支架移植物60的纵向轴线的中心线77。纵向支承件74在弯曲时可以相对于中心线77以在中心线77的纵向平面任一侧上大致纵向支承件74的一部分呈镜像的方式(这里称为“反镜像对称”)弯曲。
在一种实施方式中，支架移植物60可包括例如通过缝合而固定到移植物62的外侧的纵向支承件74，如图7C所示。在图7K所示的另一实施方式中，纵向支承件没有设置在移植物62上。
如图8所示，支架移植物60包括位于移植物62的内侧表面上的至少一个缝合线环套76。支撑线22、23的远端26、27延伸经过缝合线环套76，由此支撑线22、23可以通过支撑线22、23朝着外科医生向近侧缩回而从缝合线环套76释放。回来参考图7E，暴露的近侧顶点73、75通过顶点搭扣40的尖头42被固定到系统11、13。
如图9A和9B所示，内护套80在近端82和远端84之间渐缩，由此内护套80限定的内腔在远端84处的直径大于在近端82处的直径。另外，内护套80在远端84的下方部分83处向下扩张。此外，该扩张的开口是非对称的。下方部分83可以如图9A所示向远侧渐缩，或者如图9B所示相对于内护套84的最近端呈直线。如图10所示，内护套80的三角形部件85被附接到远端84的下方部分83。在替代实施方式中，如图11A和11B所示，内护套80限定没有扩张或者没有不对称的远侧开口。内护套80包括主纵向轴线87。
在本发明的另一实施方式中，如图12A所示，鼻锥18限定位于鼻锥18的近端87处的近侧空腔86。内护套80的远端84可配合在近侧空腔86内，由此内护套80从鼻锥18缩回使得内护套80的远端84从近侧空腔86释放。
参考图12B，不透辐射标记88被固定到内护套80的上方部分90。内护套80具有下方部分91。支架移植物60充分部分部署以便完成支架移植物60的近端70在手术部位处的定位将通过不透辐射标记78和88的对准和优选重叠来指出，如图12C所示。
包含支架移植物的内护套在通过引入器护套92输送之前受到约束，如图13所示。鼻锥18在完全缩回时与引入器护套92的远端94形成干涉配合，由此将支架移植物和内护套密封在引入器护套92内，从而输送到患者，并在患者体内输送到待部署支架移植物的手术部位。引入器护套92继而固定到系统10、11、13、100的手柄96。
本发明的方法包括推进引入器护套92，同时鼻锥18在患者动脉腔内完全缩回，且与引入器护套92形成干涉关系，直到鼻锥18靠近患者的手术部位。控制腔12、外部控制管30、推动器支承管38、顶点搭扣40和护套腔81(图5等)都可独立地从手柄96运动(图13)。手术部位例如可以是动脉瘤部位118，例如腹主动脉、升主动脉、胸主动脉或降主动脉。如图14A-14E所示，系统10、11、13经过患者动脉的推进通常通过首先将引导丝从患者的股动脉引导经过主动脉(经股动脉入路)以超过所需部署部位来实现。引导丝20延伸穿过系统10、11、13的控制腔12。系统10、11、13接着沿着引导丝推进，直到鼻锥18和引入器护套92相对于外科医生位于手术部位的近侧，如图14A所示。鼻锥18、控制腔12、推动器支承管38、支架移植物60和内护套80(图5等)接着都推进超过引入器护套92，直到鼻锥18和支架移植物60的近端70相对于外科医生位于动脉瘤的远侧，如图14B所示，此时支架移植物60和内护套80将不再被引入器护套92约束。相反，一旦内护套80和支架移植物60被推进超过引入器护套92，支架移植物60将被约束在内护套80内，该内护套80具有大于引入器护套92的内直径。内护套80接着相对于系统10、11、13的其他部分缩回，如图14C所示，其中支撑线22、23(未示出)防止支架移植物60的近端4的下方部分5转动(还被称为“翻转”)。支撑线22、23伴随顶点搭扣40(如果有的话)的致动通过合并器缩回，从而释放支架移植物60。内护套80接着完全缩回，从而完全部署支架移植物60，如图14D所示。系统10、11、13接着通过部署支架移植物60而缩回，如图14E所示。可以采用相同的通用方法来将类似的支架移植物部署在胸主动脉或主动脉弓之外的手术部位，例如包括降主动脉或升主动脉；或者将分支的支架移植物部署在腹主动脉。
更具体地，如图15A所示，内护套80接着相对于控制腔12和推动器支承管部分地缩回，由此暴露支架移植物60的近端70。优选地，内护套80通过护套腔60的缩回而缩回，直到支架移植物60上的不透辐射标记78从图15C所示的不与不透辐射标记88对准的位置改变成图15E所示的与不透辐射标记88对准的位置，其细节在图15B中表示。在支架移植物60这一部分部署时，通过经由支撑线22在支架移植物60的缝合线环套76上施加纵向限制而为该转动提供阻力，支撑线22防止支架移植物60的近端70的下方部分5在近端70处在平行于控制腔12的主轴线的大致纵向方向上转动。
在一种实施方式中，支架移植物和内护套各自包括在支架移植物部署过程中沿着内护套和支架移植物的相对运动路径纵向对准并彼此隔开的不透辐射标记，由此内护套的部分缩回将造成不透辐射标记重叠。不透辐射标记位于内护套和支架移植物的上方部分上。在一种实施方式中，内护套内的不透辐射标记是不对称的，例如D形，其中D形标记的直线部分与内护套的主纵向轴线对准。在一种实施方式中，支架移植物的不透辐射标记是细长的，并且大致与内护套的主纵向轴线对准。
支架移植物60可接着围绕其主纵向轴线转动或另外通过手柄96由外科医生定位(图13)。一旦近端70由外科医生适当定位，顶点搭扣40(如果有的话)可以由外科医生远程致动，以在支架移植物60内释放暴露的近侧顶点66(图15D)。控制腔12、推动器支承管38和护套腔81可接着单独或一起缩回(图5A到5E)。推动器支承管38的缩回将使得支撑线22从缝合线环套76缩回。控制腔12、推动器支承管38和护套腔81的连续缩回将使得支架移植物60完全部署在手术部位。系统10可接着从患者移除。通过本发明的系统和方法防止了“鸟嘴”的形成。顶点搭扣只部分地扣住内支架，例如搭扣支架72的暴露的近侧顶点73、75，并且支架移植物60的近端初始部署，接着随着内护套缩回而完全部署，由此防止“鸟嘴”的形成。
在替代实施方式中，系统11或13没有支撑线22、23以及固定元件37。在此实施方式中，除了没有支撑线之外，以上所述的类似方法可用来部署支架移植物60。搭扣支架72的至少一个暴露的近侧顶点73、75与顶点搭扣的尖头42接合。在此实施方式中，内护套80包括三角形部件85，如图10所示。另外，此实施方式最适用于将支架移植物60植入脉管，例如具有等于或小于大约27毫米(例如大约20毫米、大约22毫米、大约24毫米、大约26毫米以及27毫米)的血管(例如动脉)。此实施方式的支架移植物60通常具有大约22毫米至大约30毫米(例如大约25毫米)的膨胀外直径。
在替代实施方式中，如图16所示，其中内护套80包括具有大于内护套80的其他部分的直径的远端84。鼻锥18限定近侧空腔86，如图17所示，在鼻锥18、支架移植物60和内护套80推进超过引入器护套92之后，通过将护套腔81充分缩回以便从鼻锥18的近侧空腔86释放内护套80的远端84来缩回内护套80，如图18所示。支架移植物60的近端70由此膨胀到等于内护套80的远端84的内直径的受约束直径。在一种未示出的实施方式中，不透辐射标记78和88在支架移植物60的近端70从鼻锥18的近侧空腔86释放时重叠。替代地，内护套80包括在内护套80的近端82从近侧空腔86释放时与支架移植物60的不透辐射标记78重叠的第二不透辐射标记98。在此实施方式中，不透辐射标记98可在不透辐射标记88的远侧，并且不透辐射标记78和88可在护套80从支架移植物60部分地缩回时重叠。外科医生可接着在支架移植物60的部分或完全部署之前定向支架移植物60的近端70。在随后进行完全部署的情况下，支撑线22的设置是任选的。
替代地，在内护套80的远端84从近侧空腔86释放之后，鼻锥18通过控制腔的缩回而在支架移植物60内缩回，如图19A-19D所示。外科医生可接着进一步与鼻锥18一起或不一起推进支架移植物60和内护套，直到支架移植物60的近端78适当定位在手术部位，例如邻靠或几乎邻靠解剖结构，例如心脏瓣膜(例如主动脉瓣膜)。随后，护套腔81和内护套80可以与鼻锥18一起或不一起缩回，从而至少部分地部署支架移植物60。在一种未示出的实施方式中，支撑线22限制近端70的下方部分在大致相对于支架移植物60的主轴线纵向的方向上朝着支架移植物60的其它部分向后转动。在近端70的最终定位时，顶点66通过手柄96使得尖头42远程缩回而从顶点搭扣40的尖头42释放，并且系统11、13缩回，从而将支架移植物60完全部署在手术部位。替代地，系统11、13缩回以便在不使用支撑线22或顶点搭扣40的情况下完全部署支架移植物60。
在其它实施方式中，如图20A和20B所示，系统100包括固定有鼻锥104的控制腔102。外控制管106围绕控制腔102延伸，但是不连接到鼻锥104。至少一个支撑线108固定到外部控制管106。支撑线108大致平行于控制腔102的主轴线延伸，并且在其固定到外部控制管106的位置相对的端部处是自由的。通常，支撑线108的自由端110是弓形的。支架移植物60围绕外部控制管106并围绕支撑线108布置。内护套112被固定到鼻锥104，并且围绕支架移植物60延伸。任选地，支架移植物60可通过支架移植物60的近端70处的上述顶点搭扣(未示出)固定。控制腔102、外部控制管106和顶点搭扣(如果有的话)可以在与其连接的手柄96处控制。引入器护套(未示出)围绕内护套112、支架移植物60、外部控制管106和控制腔102延伸，并且在内护套112和支架移植物60部署之前与鼻锥104呈干涉关系。
系统100特别适用于腔内假体不通过将假体引导经过患者的股动脉(经股动脉入路)来植入，而替代地经由患者的左心室(经心尖部入路)引入。在这种实施方式中，含有支架移植物60的引入器护套92被引导经过患者心脏的左心室，直到支架移植物60横跨动脉的病变部分，例如升主动脉的动脉瘤。控制腔102接着被进一步推进，由此造成鼻锥104进一步推进和拉动内护套112与其一起，由此暴露和部署支架移植物60。支撑线提供纵向阻力，以便在部署过程中防止支架移植物60运动。一旦支架移植物60完全暴露或部署，外部控制管106被推进，从而将支撑线从支架移植物60内的环套释放，如上所述。系统100可接着经由支架移植物60缩回，并从患者移除。
在又一实施方式中，如图21A所示，系统120包括具有远端124和固定在远端124处的鼻锥126的控制腔122。支架移植物128围绕控制腔122延伸。至少一个缝合线130从鼻锥126延伸到支架移植物128的近端132，并从支架移植物128延伸到控制腔122上的固定位置134。缝合线130能够通过远程致动从支架移植物128释放，由此缝合线130与鼻锥126分开，由此部署支架移植物128。在一种实施方式中，鼻锥126包括位于缝合线130的远端处的纵向细槽133，且缝合线与细槽133呈干涉关系，由此缝合线130中增加的张力造成缝合线130脱离纵向细槽133，并且因此脱离鼻锥126。另外，缝合线130包括与未示出的环套或孔呈干涉关系的膨胀部分131，例如绳结，由此防止支架移植物128的远端132的部分130向后朝着外科医生的纵向运动，同时缝合线130的远端与鼻锥126呈干涉关系。在缝合线130从纵向细槽缩回时，缝合线可经过环套或孔缩回，由此释放支架移植物128的近端132。顶点搭扣136通过外部控制管138控制。替代地，如图21B所示，系统120锁定顶点搭扣136和外部控制管138。图21A和21B的系统中所采用的缝合线可以是包括具有生物相容材料的例如缝合肠线的细线，或者包括不锈钢或形状记忆合金的金属。
在另一实施方式中，如图22A和22B所示，围绕支架移植物60并从内护套衬里212延伸的内护套210包括限定通孔的近侧穿孔部分214。通孔可以通过图22A所示的穿孔部分214的网格或纤维限定，或者限定成单独的开口，例如图22B所示的纵向贯穿开216，该开口大致平行于内护套210的主轴线延伸。通常，通孔具有等于或大于大约25毫米的直径。通孔使得相对连续的血液在支架移植物60的植入过程中在箭头222所示的方向上从主动脉瓣膜218经由主动脉弓220流过支架移植物60。本发明的限定通孔的内护套还可用于其它所需的手术部位，例如肠系膜动脉或腹腔动脉。
可以在这里描述的系统、支架移植物和输送装置中采用2004年2月23日提交的美国申请No.10/784,462；2004年7月2日提交的美国申请No.10/884,136；2006年2月6日提交的美国申请No.11/348,176；2006年2月13日提交的美国申请No.11/353,927；2006年2月13日提交的美国申请No.11/449,337；2007年1月30日提交的美国申请No.11/699,700；2007年1月30日提交的美国申请No.11/699,701；2007年1月30日提交的美国申请No.11/700,609；2007年1月31日提交的美国申请No.11/700,510；2007年2月1日提交的美国申请No.11/701,867；2007年7月26日提交的美国申请No.11/828,675；2007年7月26日提交的美国申请No.11/828,653；2008年6月12日提交的美国申请No.12/137,592；2007年2月1日提交的美国申请No.11/701,876；2009年3与30日提交的美国申请No.61/164,545；以及2009年6月30日提交的美国申请No.12/459,387中描述的系统、系统的支架移植物和输送装置和部件、支架移植物和输送装置，其全部教导在这里通过引用整体结合于此。
所有专利、公开专利申请和参考文献的教导在这里通过引用整体结合于此。
等同性
虽然参考示例性实施方式来特别显示和描述了本发明，本领域的普通技术人员将理解到可以进行形式和细节的多种变化，而不偏离所附权利要求所包含的本发明的范围。

Claims (40)

1.一种用于植入假体的系统，包括：
a)弓形的控制腔，其具有上方侧和下方侧；
b)固定在所述弓形的控制腔的远端的鼻锥；
c)至少两个支撑线，其各自具有固定近端和相对于所述固定近端的自由远端，所述支撑线沿所述弓形的控制腔的下方侧延伸并由所述弓形控制腔向外张开，其中所述支撑线的自由远端是柔性和弓形的，并朝着所述弓形的控制腔弯曲。
2.根据权利要求1所述的系统，还包括靠近所述至少两个支撑线的自由端的至少一个止挡，其具有大于所述至少两个支撑线的直径的直径。
3.根据权利要求1所述的系统，还包括能够沿着所述弓形的控制腔滑动的外部控制管，其中所述至少两个支撑线的一端固定到外部控制管。
4.根据权利要求3所述的系统，其中所述至少两个支撑线的一端固定到鼻锥近侧的外部控制管，自由远端靠近鼻锥。
5.根据权利要求4所述的系统，还包括位于外部控制管的端部处并能够通过外部控制管的运动沿着所述弓形的控制腔滑动的顶点搭扣。
6.根据权利要求5所述的系统，还包括围绕外部控制管和至少两个支撑线延伸的支架移植物，支架移植物包括位于搭扣处的近端和靠近搭扣的远端。
7.根据权利要求6所述的系统，其中支架移植物包括限定能够释放地固定到搭扣的至少一个暴露部分的至少一个搭扣支架。
8.根据权利要求7所述的系统，其中支架移植物包括支架移植物内的用于所述至少两个支撑线中每一个的环套，其能够释放地固定每个相应支撑线的自由端。
9.根据权利要求8所述的系统，其中支架移植物包括位于支架移植物的近端的冠状支架。
10.根据权利要求9所述的系统，其中冠状支架被固定到支架移植物的移植部分的内部。
11.根据权利要求10所述的系统，其中冠状支架位于搭扣支架和支架移植物的近端之间。
12.根据权利要求1所述的系统，还包括位于至少两个支撑线的固定端的远侧或近侧并能够沿着所述弓形的控制腔滑动的推动器支承管。
13.根据权利要求12所述的系统，还包括能够沿着所述弓形的控制腔滑动的外部控制管，其中所述至少两个支撑线的一端被固定到外部控制管。
14.根据权利要求13所述的系统，还包括位于外部控制管的端部处并能够通过外部控制管的运动沿着所述弓形的控制腔滑动的顶点搭扣。
15.根据权利要求6所述的系统，其中支架移植物是分支的支架移植物。
16.根据权利要求6所述的系统，其中支架移植物还包括至少一个不透辐射标记。
17.根据权利要求15所述的系统，其中分支的支架移植物还包括至少一个不透辐射标记。
18.根据权利要求1所述的系统，其中所述至少两个支撑线由选自金属、合金和聚合物的至少一种物质形成。
19.根据权利要求18所述的系统，其中金属包括不锈钢。
20.根据权利要求18所述的系统，其中合金包括形状记忆合金。
21.根据权利要求20所述的系统，其中形状记忆合金包括镍钛合金。
22.根据权利要求1所述的系统，其中所述至少两个支撑线的自由端各自包括球根状端。
23.根据权利要求22所述的系统，其中每个支撑线是悬臂的。
24.根据权利要求23所述的系统，还包括能够沿着靠近所述至少两个支撑线的外套管滑动的护套腔。
25.根据权利要求24所述的系统，还包括从护套腔向远侧延伸的内护套。
26.根据权利要求25所述的系统，其中内护套包括位于内护套的近端处的至少一个通孔。
27.根据权利要求25所述的系统，其中内护套包括至少一个不透辐射标记。
28.根据权利要求27所述的系统，其中至少一个不透辐射标记位于背向所述弓形的控制腔限定的弯曲部凹部的内护套上，并且在支架移植物部分部署时，内护套的不透辐射标记与支架移植物的至少一个不透辐射标记重叠。
29.根据权利要求28所述的系统，其中内护套限定位于内护套的远端处的扩张开口。
30.根据权利要求29所述的系统，其中扩张开口是不对称的。
31.根据权利要求1所述的系统，还包括固定到鼻锥并围绕所述至少两个支撑线从鼻锥向近侧延伸的内护套。
32.根据权利要求31所述的系统，还包括在内护套内围绕所述弓形的控制腔和所述至少两个支撑线延伸的支架移植物。
33.根据权利要求32所述的系统，其中支架移植物包括支架移植物内的环套，该环套可释放地固定每个相应支撑线的自由端。
34.根据权利要求33所述的系统，其中环套在自由端和止挡之间可释放地固定每个相应支撑线的自由端，由此限制环套沿着所述至少两个支撑线的运动。
35.根据权利要求1所述的系统，还包括内护套，并且其中鼻锥限定装配有内护套的远侧部分的近侧空腔，由此鼻锥和内护套的相对运动使得内护套的远端从空腔释放。
36.根据权利要求35所述的系统，其中鼻锥能够在内护套释放之后在内护套内缩回。
37.根据权利要求36所述的系统，还包括内护套内的支架移植物，内护套和鼻锥能够相对于支架移植物缩回。
38.根据权利要求36所述的系统，其中支架移植物通过内护套和鼻锥一起缩回来部署。
39.根据权利要求37所述的系统，其中支架移植物包括支架移植物内的环套，该环套可释放地固定相应的支撑线，由此限制环套沿着所述至少两个支撑线的运动。
40.一种用于植入假体的系统，包括：
a)弓形的控制腔，所述弓形的控制腔具有下方侧；
b)固定在弓形的控制腔的远端的鼻锥；
c)围绕弓形的控制腔延伸的具有下方侧的支架移植物；以及
d)至少一个缝合线，所述至少一个缝合线从鼻锥延伸到支架移植物的下方侧的近端，并且从支架移植物的下方侧延伸到弓形的控制腔的下方侧上的固定位置，所述缝合线能够通过远程致动从支架移植物释放。
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