CN109069282A - 具有导引器和远侧护套的递送***及使用方法 - Google Patents
具有导引器和远侧护套的递送***及使用方法 Download PDFInfo
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- 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
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- 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
- A61F2/02—Prostheses implantable into the body
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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
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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
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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
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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
- 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
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- 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
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- A61F2250/0018—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 elasticity, stiffness or compressibility
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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Abstract
递送***及其使用方法将支架移植假体递送到外科部位,诸如腹部、胸部或胸腹主动脉瘤。递送***包括限定导管的手柄、向远侧延伸穿过手柄的导引器护套、从导引器护套的远侧端部延伸穿过手柄的导管的基本上直的内部控制管和延伸穿过并超过导引器护套的远侧端部的远侧护套。远侧护套可以在一种实施方式中具有等于或小于导引器护套的直径。远侧护套穿过导引器护套和手柄缩回使得围绕内部控制管延伸的支架移植假体暴露。内部控制管从导引器护套移除允许附加部件穿过导引器护套植入。
Description
相关申请
本申请要求2016年4月5日提交的美国临时申请No.62/318,427的权益。所述申请的全部教导通过引用合并于此。
背景技术
支架移植递送***被设计成治疗腹部主动脉瘤(AAA)、胸部主动脉瘤(TAA)和胸腹主动脉瘤(TAAA)。假体部件的成功放置对于绕过动脉瘤来说至关重要。假体可以多个单元部署,每个单元需要从递送***单独部署。在主假体的植入期间,或者在没有血管填充导管或附件的情况下,可以通过止血阀实现在更换递送装置的同时防止离体血液流动。
因此,需要开发具有治疗AAA的止血阀的新颖、实用和有效的递送***、部件和方法。
发明内容
本发明涉及一种递送***和使用所述递送***来治疗特别是AAA、TAA和TAAA的血管损伤的方法。
在一种实施方式中,本发明是一种递送组件,其包括限定导管的手柄、从手柄向远侧延伸的导引器护套,导引器护套具有位于手柄处的近侧端部和位于手柄远侧的远侧端部。基本上直的内部控制管延伸穿过手柄的导管和导引器护套,并具有位于手柄近侧的近侧端部和位于导引器护套的远侧端部远侧的远侧端部、固定到内部控制管的末端和围绕内部控制管从导引器护套的远侧端部向远侧延伸穿过手柄和导引器护套到末端的远侧护套,其中远侧护套具有大约等于或小于导引器护套的直径的直径,其中远侧护套穿过导引器护套和手柄缩回使得内部控制管暴露。在一种实施方式中,远侧护套具有大于导引器护套的直径,但是还允许穿过导引器护套缩回。
在另一实施方式中,本发明是一种将支架移植件递送到外科部位的方法。该方法包括将本发明的递送组件的远侧端部递送到腹部主动脉瘤或胸部主动脉瘤,并且将远侧护套从通过递送组件限制的支架移植件缩回,由此使得支架移植件暴露于动脉瘤。
本发明具有许多优点。例如,延伸超过导引器护套并具有等于或小于或在一些情况下大于导引器护套的直径的直径的远侧护套不必从导引器护套推进到外科部位,而是可以推进成使得递送组件的剩余部分推进到患者内,直到支架移植假***于用于植入的外科部位。一旦支架移植件部署,递送装置的附加部件(诸如内部控制管)可以穿过导引器护套从患者移除,将导引器护套留在后面,并且可用于其他目的,诸如植入完全组装的假体的附加部件,其支架移植件是一部分。因此本发明的递送组件可以用来治疗腹部主动脉瘤(AAA)、胸部主动脉瘤(TAA)和胸腹主动脉瘤(TAAA),由此避免威胁生命的血管病症造成的并发症和死亡。
附图说明
如附图所示,以上内容将从下面本发明的示例性实施方式的更特别描述中得以明白,附图中类似的附图标记在不同的附图中指的是相同的部件。附图不必按照比例,相反主要在于说明本发明的实施方式。
图1是本发明的递送组件的一种实施方式的透视图。
图1A是从所述实施方式的内部控制管缩回之后的图1的递送组件的导引器护套的远侧端部的细节。
图2是支架移植假体从递送组件的远侧护套内部署之前的图1的递送组件的一种实施方式的局部横截面图。
图2A-2C是图2所示的实施方式的细节视图。
图3是适用于本发明的止血阀的透视横截面图。
图3A是图3的细节,示出本发明的一种实施方式的止血阀、远侧护套、中间管、内部控制管和顶点释放管腔之间的关系。
图4是图2的本发明的递送组件的横截面图,其中远侧护套从递送组件的末端部分缩回穿过组件的导引器护套和手柄。
图5是远侧护套进一步缩回和支架卡扣组装在末端处打开之后的递送组件的横截面图。
图6是图1的递送组件的透视图,其中远侧护套从支架移植件完全缩回。
图7是远侧护套穿过导引器护套和手柄完全缩回之后的图5和6的递送组件的横截面图。
图8A和8B是图1-7的递送组件的透视图,其中螺杆从手柄和止血阀移除,以允许手柄、远侧护套、中间管、顶点释放管腔和内部控制管从患者的外科部位缩回。
图9是内部控制管、卡扣组装(在打开时)和末端部分缩回之后的图7所示的递送组件的横截面图。
图10A和10B是远侧护套的手柄从导引器护套的止血阀完全缩回之后的图6的远侧组件的透视图。
具体实施方式
本发明总体涉及用于在AAA、TAA或TTAA的部位处植入支架移植件的递送***。
本发明的特征和其他细节、本发明的步骤或本发明部件的组合现在将在权利要求中更特别地描述和指明。将理解到本发明的特定实施方式通过说明示出,并且不作为本发明的限制。本发明的主要特征可以在多种实施方式中应用,而不偏离本发明的范围。
在对于递送***或递送***的部件进行参照时,“近侧”指的是相对靠近使用装置的医务人员。相反,在对于递送***和递送***的部件进行参照时,“远侧”指的是相对远离使用装置的医务人员。
在对于“支架”和“支架移植***”进行参照时,“近侧”指的是支架或支架移植***的端部相对靠近患者的心脏,并且“远侧”指的是支架或支架移植***的端部相对远离患者的心脏。
为了清楚起见,与上面相对于血管修复装置或递送***描述的“近侧”或“远侧”含义不同,术语“邻近”指的是靠近。
在一种实施方式中,如图1所示,本发明的递送组件10包括手柄12。手柄12具有近侧端部14和远侧端部16,并限定导管。手柄12由阳极氧化铝、聚苯乙烯、聚丙烯、聚乙烯、聚氯乙烯、尼龙聚碳酸酯、聚酯、聚氨酯的适当材料或本领域已知的任何其他适当工程塑料形成。止血阀部件18通过释放销50可释放地固定到手柄12的远侧端部16。适当止血阀的一个例子在2016年9月13日授权的美国专利9,439,751中描述,其相关教导通过引用整体合并与此。
导引器护套20从与其固定的止血阀18向远侧延伸。导引器护套20包括位于止血阀18处的近侧端部22和位于手柄12远侧的远侧端部24。导引器护套20由本领域普通技术人员已知的诸如的优选柔性材料、聚对苯二甲酸乙二醇酯(PET,也称PETE)、氟化乙烯丙烯(FEP)或聚四氟乙烯的适当材料制造。在一种特定实施方式中,导引器护套20被制造成管,其由盘绕的镍钛诺、高密度聚醚(HDPE)/聚醚嵌段酰胺(例如)、不锈钢(SS)线圈和芳香族聚酰胺纤维形成。导引器护套20限定导管。手柄12和导引器护套20的导管是基本上同轴的。
参考图1A和2,内部控制管26延伸穿过手柄12和导引器护套20的导管。内部控制管26具有位于手柄12近侧的近侧端部28和位于导引器护套20的远侧端部24远侧的远侧端部30。内部控制管26限定管腔导管。
末端32固定到内部控制管26的远侧端部30(图2A)并限定导丝(未示出)可以引导穿过其中的导管。末端32由本领域普通技术人员已知的诸如芳香族聚醚型热塑性聚氨酯(TPU)的适当材料形成。
远侧护套34延伸穿过手柄12和导引器护套20,并且还从导引器护套20的远侧端部24围绕内部控制管26向远侧延伸到末端32。远侧护套34具有等于或小于导引器护套20的直径的直径,由此远侧护套34穿过导引器护套20和手柄12缩回使得内部控制管26暴露。远侧护套34由适当材料形成,诸如与导引器护套20相同或类似的材料的适当柔性材料,或本领域普通技术人员已知的材料。在一种实施方式中,远侧护套34由比导引器护套20的材料更加柔性的材料制造。
内部控制管26可以手动或通过适当机构(诸如美国专利No.8,998,970中描述的,其相关教导通过引用整体合并与此)独立地缩回穿过导引器护套20和手柄12。
通常,末端32具有比导引器护套20限定的导管和手柄12限定的导管小的外侧直径,使得远侧护套34、内部控制管26和末端34可以缩回穿过导引器护套20和止血阀8限定的导管,并由此从导引器护套20和止血阀18内移除。
手柄12还沿着手柄12的远侧抓握部38限定轨道36,如图1所示。内部导螺杆组件40位于手柄12的导管内,并能够沿着手柄12的主轴线39运动。内部导螺杆组件40还包括延伸穿过轨道36的螺纹部分42。导螺杆螺母44围绕手柄12延伸并且与内部导螺杆组件40的螺纹部分42螺纹接合,由此导螺杆螺母44在邻接远侧抓握部38的同时旋转(如箭头41所示)造成内部导螺杆组件40相对于手柄12运动,如图6的选项I所示。导螺杆螺母44还能够在与内部导螺杆组件40接合的同时沿着手柄12滑动,如图6的选项II所示,而不需要旋转导螺杆螺母44,由此提供造成内部导螺杆组件40相对于手柄12运动的至少两个独立机构。本发明的支架移植递送***10的内部导螺杆组件40限定与手柄12基本上同轴的开口,其中内部控制管26延伸穿过内部导螺杆组件40。
内部控制管26固定到手柄12。远侧护套34围绕内部控制管26延伸并直接或间接地固定到内部导螺杆组件40,由此内部导螺杆组件40相对于手柄12的运动造成远侧护套34相对于导引器护套20的相对纵向运动。
如图3所示,支架移植递送***10的止血阀18包括限定远侧护套34和内部控制管26延伸穿过其中的中心孔口(图3A)以及基本上垂直于中心孔口延伸的冲洗阀孔口48的止血阀主体46,止血阀主体46通过诸如例如释放销50的适当装置可拆卸地固定到手柄12,释放销50延伸穿过内部导螺杆组件40,在开口51处进入止血阀18,如图1和6所示。返回图3,盖52联接到止血阀主体46的远侧端部53。盖52限定与止血阀主体46的中心孔口基本上对准并且远侧护套34和内部控制管26延伸穿过其中的中心孔口。止血阀旋钮54螺纹地联接到止血阀主体46。导引器护套20从盖52向远侧延伸并限定与止血阀主体46的中心开口基本上对准并且远侧护套34和内部控制管26延伸穿过其中的管腔。刮擦器阀56邻近冲洗阀孔口48位于止血阀18的中心开口处。刮擦器阀56形成围绕内部控制管26的密封。X-阀60在刮擦器阀56的近侧位于止血阀18的中心开口处。X-阀60在内部控制管26从止血阀18回缩时形成围绕内部控制管26内的导丝的密封。护套阀62位于止血阀18的中心开口处并位于X-阀60的近侧。止血护套阀18能够通过旋钮54的致动操作,由此通过关闭护套阀62来密封中心开口。刮擦器阀56操作围绕远侧护套34密封止血阀18。在远侧护套34移除时,X-阀60变成止血阀18的主要密封。
回来参考图2,递送***10还包括支架移植假体70,支架移植假体70在远侧护套34内纵向地、并在末端32的近侧围绕内部控制管26径向地延伸。支架移植件70包括管腔壁72、近侧远端74、远侧端部76和沿着管腔壁72纵向延伸的多个径向支架77。(图2C)远侧护套34在导引器护套20内缩回使得支架移植假体70暴露,如图4所示。在一种实施方式中,多个支架77是自膨胀的。在一种实施方式中,支架77包括支柱79,其中支柱79的至少一部分限定顶点81。(图2C)在一种实施方式中,自膨胀裸支架78从支架移植壁72的近侧端部74向近侧延伸。裸支架78任选地包括(虽然未示出)从壁70的远侧端部向远侧延伸的裸支架。通常,支架77和78由本领域普通技术人员已知的诸如镍钛诺的适当材料形成。
支架卡扣装置84位于内部控制管26的远侧端部30处并包括远侧卡扣部分86和近侧卡扣部分88,其中近侧和远侧卡扣部分限定可以可释放地固定裸支架78的至少一个顶点82的开口和围绕内部控制管26延伸并在远侧护套34内的顶点释放管腔90。近侧卡扣部分88固定到顶点释放管腔90并且延伸穿过手柄12,由此顶点释放管腔90的缩回将使得近侧卡扣部分88从远侧卡扣部分86分离,由此释放支架移植件70的近侧端部74,诸如通过释放支架移植假体70的裸支架78的至少一个顶点82。递送***10还可包括围绕顶点释放管腔90并在导引器护套20内延伸的中间管92,其中中间管92的远侧端部94包括邻接支架移植假体70的远侧端部76的支撑件96。
在另一实施方式中,本发明是将支架移植件递送到外科部位的方法。该方法在一种实施方式中包括在诸如图1-10B的递送***10的递送***的远侧护套34内引导支架移植假体70到腹部主动脉瘤(AAA)、胸部主动脉瘤(TAA)或胸腹主动脉瘤(TAAA)内的植入部位的步骤。随后,远侧护套34通过导螺杆螺母44在图1所示的方向41上旋转和图6的选项I的至少一种方式从支架移植件70缩回,以造成远侧护套34缩回,如图2和4所示,由此使得支架移植件70暴露于动脉瘤。替代地,导螺纹螺母44可以沿着手柄12直接滑动返回,如图6的选项II所示。在一种特定实施方式中,同样如图4和5所示,支架移植件70的裸支架78通过支架卡扣装置84固定到内部控制管26的远侧端部30,并且在此实施方式中,该方法还包括通过将支架卡扣装置84从图4所示的闭合位置运动到图5所示的打开位置使得处于动脉瘤处、附近或周围的植入部位处的支架移植件70释放的步骤。但是,理解到虽然这里描述和附图所示的例子采用了通过支架卡扣装置84卡扣的裸支架,在替代例子中可以采用其他机构。例如,支架移植假体70的近侧端部74可以通过在近侧端部74处不包括裸支架的支架移植件70的实施方式中在由末端32限定的孔口内的干涉配合在管腔壁72的近侧端部74处卡扣。替代地,支架移植件可以如上所述通过支架卡扣装置84卡扣,其中支架移植件包括冠状支架和夹持支架,如美国专利9,198,786所教导那样,其相关教导通过引导整体合并与此。
随后,远侧护套34完全缩回到导引器护套20内,以便完全释放支架移植假体70,如图7所示。螺杆98接着被移除,如图8所示,以便从手柄12释放止血阀18,由此卡扣装置84、内部控制管26和末端32可以缩回穿过植入的支架移植件70,如图9所示,并且穿过导引器护套20和止血阀18,如图10所示。止血阀18接着通过如图1和10B的箭头55所示旋转旋钮54(图3)来关闭,以防止血液流失,直到诸如进一步的支架移植件部件穿过止血阀20和导引器护套20的其他外科步骤完成。支架移植假体的任何附加部件(诸如分叉假体(未示出)的腿部)穿过止血阀18和导引器护套20植入之后,止血阀20和导引器护套20可以从受体移除,以完成外科程序。
本文引用的所有专利、公开申请的相关教导通过引用整体合并。美国专利Nos.8,292,943、7,763,063、8,308,790、8,070,790、8,740,963、8,007,605、9,320,631、8,062,349、9,198,786、8,062,345、9,561,124、9,173,755、8,449,595、8,636,788、9,333,104、9,408,734、9,408,735、8,500,792、9,220,617、9,364,314、9,101,506、8,998,970、9,554,929、9,439,751和美国专利申请No.14/226,005、14/675,102、15/099,974;15/040,460、14/575,673、14/924,102、15/166,818、15/167,055、14/736,978、13/454,447、15/384,663、13/788,724、15/417,467、15/230,601、14/272,818和14/861,479的相关教导同样通过引用整体合并。
虽然参考其示例性实施方式特别示出和描述了本发明,本领域普通技术人员将理解到可以进行形式和细节上的多种变化,而不偏离所附权利要求所包含的本发明的范围。
Claims (18)
1.一种递送组件,包括:
a)手柄,所述手柄限定导管;
b)导引器护套,所述导引器护套从所述手柄向远侧延伸,所述导引器护套具有位于所述手柄处的近侧端部和位于所述手柄远侧的远侧端部;
c)基本上直的内部控制管,所述内部控制管从所述导引器护套的远侧端部延伸穿过所述手柄的导管,所述内部控制管具有位于所述手柄近侧的近侧端部和位于所述导引器护套的远侧端部远侧的远侧端部;
d)末端,所述末端固定到所述内部控制管的远侧端部;以及
e)远侧护套,所述远侧护套围绕所述内部控制管从所述导引器护套的远侧端部向远侧延伸穿过所述手柄和所述导引器护套到所述末端,其中所述远侧护套具有等于或小于所述导引器护套的直径的直径,由此所述远侧护套穿过所述导引器护套和所述手柄缩回使得所述内部控制管暴露。
2.根据权利要求1所述的递送组件,其中,所述手柄包括密封所述导管的止血阀部件。
3.根据权利要求2所述的递送***,其中,所述阀是止血阀。
4.根据权利要求2所述的递送组件,其中,所述手柄还限定与所述导管流体连通并位于所述止血阀远侧的冲洗端口。
5.根据权利要求4所述的递送组件,其中,所述远侧护套具有比导引器护套的材料更柔软的材料。
6.根据权利要求5所述的递送组件,其中,所述末端具有小于所述导引器护套和所述导管的内侧直径的外侧直径,由此所述远侧护套、所述内部控制管和所述末端能够穿过所述导引器护套和所述导管缩回,并且由此从所述导引器护套和所述手柄移除。
7.根据权利要求1所述的递送组件,还包括支架移植假体,所述支架移植假体在所述远侧护套内纵向地、围绕所述远侧护套径向地并在所述末端近侧围绕所述内部控制管延伸,所述支架移植件包括管腔壁、近侧端部和远侧端部以及沿着所述管腔壁纵向延伸的多个径向支架,由此所述远侧护套的缩回将使得所述支架移植假体暴露。
8.根据权利要求7所述的递送组件,其中,所述支架移植假体包括多个自膨胀支架。
9.根据权利要求8所述递送组件,其中,所述自膨胀支架位于所述支架移植假体的近侧端部和远侧端部处。
10.根据权利要求7所述的递送***,其中,所述支架的至少一部分包括支柱,并且其中所述支柱的至少一部分限定顶点。
11.根据权利要求10所述的递送***,其中,所述顶点的一部分被暴露。
12.根据权利要求11所述的递送***,还包括位于所述末端处的支架卡扣装置,所述卡扣装置包括:
a)远侧卡扣部分;
b)近侧卡扣部分,其中所述远侧卡扣部分和所述近侧卡扣部分限定能够可释放地固定所述支架移植件的近侧端部的开口;以及
c)位于所述内部控制管和所述远侧护套之间的顶点释放管腔,所述顶点释放管腔固定到所述近侧卡扣部分并延伸穿过所述手柄,由此所述释放管腔的缩回将使得所述近侧卡扣部分从所述远侧卡扣部分分离,由此释放所述支架移植件的近侧端部。
13.根据权利要求12所述的递送组件,由此,所述卡扣装置卡扣所述支架移植件的至少一个支架的至少一个顶点,由此所述近侧卡扣部分从所述远侧卡扣部分缩回使得至少一个顶点释放,并且随后使得所述支架移植件的近侧端部释放。
14.根据权利要求13所述的递送组件,还包括围绕所述释放管腔延伸并具有远侧端部的中间管,所述远侧端部包括位于所述卡扣装置近侧的支撑件。
15.一种将支架移植件递送到植入部位的方法,包括如下步骤:
a)将递送组件的远侧端部引导到腹部主动脉瘤或胸腹主动脉瘤或胸部主动脉瘤内的植入部位,所述递送组件包括:
i)手柄,所述手柄限定导管;
ii)导引器护套,所述导引器护套从所述手柄向远侧延伸,所述导引器护套具有位于所述手柄处的近侧端部和位于所述手柄远侧的远侧端部;
iii)基本上直的内部控制管,所述内部控制管从所述导引器护套的远侧端部延伸穿过所述手柄的导管,所述内部控制管具有位于所述手柄近侧的近侧端部和位于所述导引器护套的远侧端部远侧的远侧端部;
iv)末端,所述末端固定到所述内部控制管的远侧端部;以及
v)远侧护套,所述远侧护套围绕所述内部控制管从所述导引器护套的远侧端部向远侧延伸穿过所述手柄和所述导引器护套到所述末端,其中所述远侧护套具有大约等于或小于所述导引器护套的直径的直径,由此所述远侧护套穿过所述导引器护套和所述手柄缩回使得所述内部控制管暴露;以及
vi)支架移植件,所述支架移植件包括管腔壁、近侧端部和远侧端部以及沿着所述管腔壁纵向分布的多个径向自膨胀支架,所述支架移植件围绕所述内部控制管并在所述远侧护套内延伸,其中所述支架移植件的近侧端部邻近所述内部控制管的远侧端部;以及
b)使得所述远侧护套从所述支架移植件缩回,由此将所述支架移植件递送到主动脉内的植入部位。
16.根据权利要求15所述的方法,其中,所述支架移植件的近侧端部通过卡扣装置固定到所述内部控制管的远侧端部,并且还包括通过使得所述卡扣装置从闭合位置运动到打开位置而释放植入部位处的支架移植件的步骤。
17.根据权利要求16所述的方法,其中,所述卡扣装置包括位于所述内部控制管的远侧端部处的远侧卡扣部分、能够沿着所述内部控制管运动并与所述远侧卡扣部分协作来可释放地卡扣所述支架移植件的近侧端部的近侧卡扣部分以及在所述内部控制管和所述远侧护套之间延伸的释放管腔,由此所述释放管腔的缩回使得所述近侧卡扣部分从所述远侧卡扣部分分离,以便打开且由此释放所述植入部位处的所述支架移植件,并且还包括打开所述卡扣装置由此释放位于所述植入部位处的所述支架移植件的步骤。
18.根据权利要求17所述的方法,其中,所述支架移植件的支架的至少一部分包括限定顶点的支架,所述顶点的至少一部分被暴露并通过所述卡扣装置卡扣,并且由此所述支架移植件通过使得所述顶点从所述卡扣装置释放而释放。
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JP2019510579A (ja) | 2019-04-18 |
US20170281382A1 (en) | 2017-10-05 |
EP3439586A1 (en) | 2019-02-13 |
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