CN103930075B - 用于可扩张装置的腔内展开的外部可转向纤维 - Google Patents
用于可扩张装置的腔内展开的外部可转向纤维 Download PDFInfo
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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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- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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- A—HUMAN NECESSITIES
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- 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
- A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
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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
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- 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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Abstract
本发明描述了用可扩张植入物对患者脉管结构的治疗。该植入物通过至少一个套管被约束到缩小的递送直径以在脉管结构内进行递送。该植入物可被约束到其它直径,诸如中间直径。这些套管可扩张,从而通过从患者体外使联接构件与套管脱开而允许可扩张植入物的直径扩张。可扩张植入物可包括便于可扩张植入物弯曲和转向穿过患者脉管结构的一根或多根转向线。
Description
相关申请的交叉引用
本申请要求2011年11月14日提交的题为“EXTERNABLE STEERABLE FIBER FOR USEIN ENDOLUMINAL DEPLOYMENT OF EXPANDABLE DEVICES(用于可扩张装置的腔内展开的外部可转向纤维)”的美国临时申请序列号第61/559,408号的优先权,其全文以参见的方式纳入本文。
背景技术
领域
本发明总体设计腔内装置,且更具体涉及患者的脉管结构内的转向可扩张腔内装置。
背景技术
腔内治疗通常涉及插入递送导管,以将可植入的假体装置通过位于远处脉管内的较小的、经常是经皮的接近部位运送到脉管结构内。一旦实现接近脉管结构,递送导管用于通过几种技术中的一种来调整装置的腔内递送和后续展开。以此方式,装置能在远处植入,以达到治疗效果。与传统的外科手术治疗相比,腔内治疗的特征是它们的“最小侵入性”特点。
可扩张腔内装置可由在支架空隙上带有或不带有移植物覆盖物的移植物或支架部件构成。它们可设计成当去除约束时从它们的递送直径通过一系列中间直径扩张或囊体扩张成最大预定功能直径。可扩张腔内装置的腔内递送和展开具有几个特有的问题。例如,腔内装置本身必须被约束到合适的可引入尺寸(或递送直径),以允许插入脉管结构内,并安装到诸如导管轴杆之类的递送装置上。在这种构造中,腔内装置会难以行进穿过具有显著弯曲或曲率的脉管。
因此,理想的是提供将可扩张腔内装置特别是沿曲折脉管、诸如沿主动脉弓经腔内递送到脉管治疗部位的系统。
附图说明
附图在此用于对本发明的进一步理解,并被包含到本说明书中且构成其一部分,且示出本发明的实施方式而与说明书描述一起可用于解释本发明的原理,其中:
图1示出具有可扩张植入物的导管组件的侧视图;
图2A和2B示出具有可扩张植入物的导管组件的立体图;
图3A-3B和3C-3D分别示出具有可扩张植入物的导管组件的剖视图和立体图;
图4示出可扩张植入物的远端的各种轮廓视图;
图5A-5D示出具有可扩张植入物的导管组件的立体图;
图6示出可扩张植入物的立体图;
图7A-7H示出具有转向纤维的可扩张植入物和套管的剖视图;
图8示出具有可扩张植入物的导管组件的剖视图;以及
图9示出具有可扩张植入物的导管组件的侧视图。
例示实施例的详细描述
本领域的技术人员将容易理解,本发明的各方面可通过任何数量的方法和构造成执行预期功能的设备来实现。换句话说,其它方法和设备可被包含在这里以执行预期功能。还应指出这里参考的附图并非都是按比例绘制,而是可扩大来说明本发明的各方面,且在这方面,各视图不应被认为是限制性的。
在整个说明书中和权利要求书中,术语“远侧”是指这样一种位置,即,在支架植入时,相对于血流而言,腔内装置(诸如支架-移植物)的一部分比装置的另一部分在更下游处。相似地,术语“远侧地”是指血流的方向或沿血流方向更下游。
术语“近侧”是指这样一种位置,即,在支架植入时,相对于血流而言,腔内装置的一部分比装置的另一部分在更上游处。相似地,术语“近侧”是指与上述血流方向相反的方向或从血流方向上游的方向。
此外关于术语近侧和远侧,并且因为本发明不限于外周和/或中心逼近,本发明不应就这些术语作狭义地理解。相反,文中所述的装置和方法可相对于患者的解剖结构变化和/或调整。
在该整个说明书和权利要求书中,术语“前”是指装置上更靠近装置的插入并行进穿过患者脉管的端部的相对位置。术语“尾”是指装置上更靠近装置的位于患者脉管外的端部的相对位置。
在各种实施例中,公开了一种导管组件,该导管组件利用单个或多个挠性套管,套管(i)将诸如可扩张腔内支架移植物之类的可扩张植入物可释放地约束到一尺寸,该尺寸适于将该植入物在腔内递送到诸如患者体内的脉管构件之类的治疗部位;并(ii)还将植入物约束到如下外周尺寸,该外周尺寸比适于腔内递送的尺寸大、但比不受约束的或完全展开的外周尺寸小,由此便于在将植入物完全展开和扩张到之前将植入物选择性轴向和/或转动定位在治疗部位处。
本发明的各种实施例包括导管组件,该导管组件构造成将可扩张植入物递送到患者脉管结构的治疗区域。根据本发明的各实施例,导管组件包括至少一根转向线。转向线允许可扩张植入物在脉管结构内选择性地弯曲。
首先参照图1,根据本发明的导管组件100包括导管杆102、主内腔103以及可扩张植入物106。可扩张植入物106可包括适于递送到脉管结构的治疗区域的任何腔内装置。这种装置可包括例如支架、移植物和支架移植物。
在各种实施例中,可扩张植入物106包括支架移植物。常规支架移植物设计成从其递送直径通过一系列的中间直径扩大到最大的预定功能直径,并且通常包括一个或多个支架部件,支架部件具有在支架上方和/或下方移位的一个或多个移植物构件。
在各种实施例中,可扩张植入物106包括由镍钛诺制成的一个或多个支架部件和由ePTFE制成的移植物构件。然而并且如下所讨论的那样,支架部件和移植物构件的任何适当组合都在本发明范围内。
例如,支架部件可具有各种构造,诸如例如由环、切割管、缠绕线材(或带)或卷成管状的平坦带图案化片材。支架部件可由金属、聚合物或天然材料制成,并可包括传统医疗级别的材料,诸如尼龙、聚丙烯酰胺、聚碳酸酯、聚乙烯、聚甲醛、聚甲基丙烯酸甲酯、聚丙烯、聚四氟乙烯、聚三氟氯乙烯、聚氯乙烯、聚氨酯、弹性有机硅聚合物、诸如不锈钢、钴铬合金和镍钛诺的金属以及诸如牛动脉/静脉、心包膜和胶原的生物衍生材料。支架部件还可包括可生物可吸收材料,诸如聚(氨基酸类)、聚(酐)、聚(己内酯)、聚(乳酸/乙醇酸)聚合物、聚(羟基丁酸盐)以及聚(原酸酯)。可通过导管递送的任何可扩张支架部件构造都是根据本发明的。
此外,用于移植物构件的可能材料包括例如膨胀型聚四氟乙烯(ePTFE)、聚酯、聚氨酯、诸如全氟弹性体等的含氟聚合物、聚四氟乙烯、硅酮、尿烷、超高分子量聚乙烯、芳纶纤维及其组合。用于移植物构件材料的其它实施例可包括高强度聚合物纤维,诸如超高分子量聚乙烯纤维(例如,、Dyneema 等)或者芳纶纤维(例如等)。移植物构件可包括生物活性剂。在一个实施例中,ePTFE移植物沿其与血液接触的表面包括碳成分。可通过导管递送的任何移植物部件都是根据本发明的。
在各种实施例中,支架部件和/或移植物构件可包括治疗性涂层。在这些实施例中,支架部件和/或移植物构件的内部或外部可涂有例如CD34抗原。此外,任何数量的药物或治疗剂可用于涂覆移植物构件,它们包括例如肝素、雷帕霉素、紫杉醇、依维莫司、ABT-578、霉酚酸、他克莫司、雌二醇、氧自由基清除剂、派尔莫司A9、抗CD34抗体、血小板衍生生长因子受体阻断剂、MMP-1受体阻断剂、血管内皮生长因子、G-CSF、HMG-CoA还原酶抑制剂、iNOS(诱导型一氧化氮合成酶)和eNOS(内皮一氧化氮合成酶)的刺激物、ACE抑制剂、ARB类药物、多西环素、沙利度胺等。
在各种实施例中,可扩张植入物106可包括径向塌缩构造,该径向塌缩构造适于递送到患者的脉管结构的治疗区域。可扩张植入物106可约束在径向塌缩构造,并安装到诸如导管轴杆102的递送装置上。处于塌缩构造的可扩张植入物106的直径足够小,以使植入物通过脉管结构递送到治疗区域。在各种实施例中,塌缩构造的直径足够小,以将导管组件100的截面轮廓减到最小并减小或防止对患者的组织伤害。在塌缩构造下,可扩张植入物106可由导管轴杆102引导通过脉管结构。
在各种实施例中,可扩张植入物106可包括径向扩张构造,该径向扩张构造适于将装置植入患者脉管结构的治疗区域。在扩张构造,可扩张植入物106的直径可以大致等于待修复的血管直径。在其它实施例中,处于扩张构造的可扩张植入物106的直径可略大于待治疗的血管,以提供血管内的牵引配合。
在各种实施例中,可扩张植入物106可包括诸如可自扩张支架移植物的可自扩张装置。这种装置在不受约束时从径向塌缩构造扩大到径向扩张构造。在其它实施例中,可扩张植入物106可包括借助诸如囊体之类的辅助装置进行扩张的装置。在有一些实施例中,导管组件100可包括多个可扩张植入物106。采用具有任何数量的可扩张植入物的导管组件都在本发明范围内。
根据本发明的各种医疗装置包括一个或多个套管。一个或多个套管可将可扩张植入装置约束在塌缩构造下,以使移植物在腔内递送到患者脉管结构的治疗部分。为了本公开的目的,术语“约束”可指(i)通过自扩张或借助装置限制可扩张植入物的直径的扩张,或者(ii)覆盖或围绕可扩张植入物而不抑制可扩张植入物(例如,为了储存或生物兼容的原因和/或为了向可扩张植入物和/或脉管结构提供保护)。例如,导管组件100包括套管104。套管104围绕可扩张植入物106并将其约束到缩小直径。
在将可扩张植入物递送到患者脉管结构的治疗部分之后,一个或多个套管可去除约束以允许可扩张植入物扩张到其功能直径并实现所需治疗效果。在各实施例中,一个或多个套管可保持植入同时不与可扩张植入物干扰。在其它实施例中,一个或多个套管可在可扩张植入物成功展开之后从患者体内移除。
在各种实施例中,可扩张植入物由周向围绕可扩张植入物的单个套管约束。例如,参照图2B,导管组件200包括套管204。在各种实施例中,套管204周向围绕可扩张植入物206,并将其约束在塌缩构造,在该塌缩构造下,可扩张植入物的直径小于不受约束的植入物的直径。例如,套管204可将可扩张植入物206约束在塌缩构造下,以在脉管结构内进行递送。
在其它实施例中,可扩张植入物由周向围绕可扩张植入物的多个套管约束。多个套管可包括彼此周向围绕的至少两个套管。
在各种实施例中,套管可以是管状并用于约束可扩张植入物。在这种构造中,套管由卷绕或折叠在可扩张植入物周围的一个或多个材料片构成。尽管文中的示例性实施例描述成包括一个或多个管状套管,但对应于下置的可扩张植入物的任何非管状套管或针对给定应用以其它方式适当成形的套管也在本发明范围内。
在各实施例中,套管通过将材料片卷绕或折叠以使片的两个平行边缘基本上对准来形成。所述对准可以与导管组件的导管轴杆平行或同轴或不平行或不同轴。在各实施例中,材料片的边缘不彼此接触。
在各实施例中,材料片的边缘彼此接触,并如下所述借助联接构件(如下所述)、粘结剂等来联接。在各其它实施例中,材料片的边缘对准成使片的同一侧(例如,片的正面/第一主表面或背面/第二主表面)的边缘彼此接触。在又一些实施例中,材料片的相对侧的边缘彼此接触,以使得边缘彼此交叠,以使片的一侧的一部分与另一侧的一部分接触。换言之,片的正面可与片的背面交叠或相反。
在各种实施例中,套管包括类似于用于形成移植物构件的材料。例如,用于制成套管的前体挠性片可由平坦薄壁ePTFE管形成。薄壁管可包含呈附连于或嵌入材料片或管壁的纵向高强度纤维形式的“防撕裂件”。
用于形成套管的材料片可包括一系列开口,以使得开口从片的一个边缘延伸到另一个边缘。在这种构造中,联接构件可以通过材料片内的该一系列开口织造或缝合,从而将两个边缘中的每个边缘固定在一起并形成管子。例如,在图1中,联接构件124将套管104的边缘固定,以使得套管104将可扩张植入物106保持在缩小直径。
在各实施例中,联接构件可包括编织纤维。在其它实施例中,联接构件可包括单丝纤维。能够将套管保持在管状的任何类型的条、绳、线、纤维或线材均在本发明的范围内。
在各实施例中,单个联接构件可用于约束一个或多个套管的直径。在其它实施例中,多个联接构件可用于约束一个或多个套管的直径。
在各种实施例中,一旦合适的可扩张植入物处于塌缩构造,则可扩张植入物可在患者的脉管结构内展开。可将塌缩构造下的可扩张植入物引入脉管结构内,并由导管组件引导到脉管结构的治疗区域。一旦在脉管结构的治疗区域内就位,可扩张植入物就可扩张成扩张构造。
在各实施例中,当可扩张植入物在脉管结构内就位时,一个或多个联接构件可从患者人体外与一个或多个套管脱开,这允许套管打开并使可扩张植入物扩张。如上文讨论的,可扩张植入物可以是自扩张的,或者植入物可通过诸如囊体的装置来扩张。
联接构件可通过从患者体外操作的机械机构来与一个或多个套管脱开。例如,一个或多个构件可通过向构件施加足够的张力来脱开。在另一示例中,拨盘或转动元件可在人体外附连到一个或多个联接构件。拨盘或转动元件的转动可提供足够的张力来移位并与一个或多个联接构件脱开。
在其它构造中,一个或多个联接构件可通过诸如溶解的非机械机理或者通过提供超声波能量来脱开。在这种构造中,向联接构件提供足够的超声波能量以使它们与一个或多个套管脱开。
在各实施例中,使将单个套管闭合的单个联接构件与套管脱开允许可扩张装置扩张。例如,参照图2A,导管组件200可用于将可扩张植入物206递送到脉管结构的治疗区域。可扩张植入物206具有用于递送的塌缩直径,并且套管204周向围绕可扩张植入物206,并通过联接构件224保持闭合。如下文更详细描述的,在完全扩张之前(例如处于中间直径)可控制可扩张植入物206的弯曲,以辅助便于递送到所需位置。一旦可扩张植入物206相对于治疗区域就位,则联接构件224与套管204脱开,并且释放套管204,从而允许可扩张植入物206扩张到较大直径。
如上所述,在本发明的各实施例中,可扩张植入物还可包括中间构造。在中间构造下,可扩张植入物的直径约束在小于扩张构造且大于塌缩构造的直径。例如,可扩张装置在中间构造下的直径可以是可扩张装置在扩张构造下的直径的约50%。但小于扩张构造直径且大于塌缩构造直径的中间构造的任何直径都在本发明范围内。
在这种构造中,一旦植入物已递送到患者的脉管结构的治疗区域附近,则可扩张植入物可从塌缩构造扩张到中间构造。中间构造主要可有助于将可扩张植入物适当地定向和定位在脉管结构的治疗区域内。
在各实施例中,可扩张植入物可由具有不同直径的两个套管同心围绕。在这些构造中,主套管将可扩张植入物约束在塌缩构造下。一旦打开塌缩构造套管,则辅助套管将可扩张植入物约束在中间构造。如上文讨论的,可扩张植入物可以是自扩张的,或者植入物可通过诸如囊体的装置来扩张。
例如,参照图2A,导管组件200包括可扩张移植物206和套管204。辅助套管204将可扩张植入物206约束到中间构造。辅助套管204通过辅助联接构件224在可扩张植入物206周围保持就位。
导管组件200还包括主套管208,该主套管208将可扩张植入物206约束在塌缩构造,以递送到患者的脉管结构。主套管208通过主联接构件234在可扩张植入物206周围保持就位。
一旦可扩张植入物206足够靠近脉管结构的治疗区域,主联接构件234与主套管208脱开,这释放主套管208并允许扩张的植入物206扩张到较大直径。
参照图2B,在主套管208已扩张之后,辅助套管204将可扩张植入物206约束在中间构造下。在中间构造下,如上所述且如下文更详细描述的,可将可扩张植入物206定向和调整(例如,通过弯曲和扭转转动)到脉管结构的治疗区域内的所需位置。
在本发明的其它实施例中,可使用单个套管将可扩张植入物约束在塌缩构造和中间构造。例如,参见图3A-3D,导管组件300包括可扩张植入物306、单套管304、主联接构件334和辅助联接构件324。
单套管504还包括多个辅助孔332。在该构造下,将辅助联接构件324经由辅助孔332缝合或编织,从而将单套管304和可扩张植入物306约束到中间构造的直径。在中间构造下,可扩张植入物306的直径小于扩张直径并大于塌缩构造的直径。在中间构造,如下文更详细描述的,可将可扩张植入物306定向和调整(例如,通过弯曲和扭动旋转)到脉管结构的治疗区域内的所需位置。
单套管304还包括多个主孔330。在该构造中,将主联接构件334通过主孔330缝合或编织,从而将单套管304和可扩张植入物306约束到塌缩构造的直径。将塌缩构造的直径选择成允许将可扩张植入物306递送到患者的脉管结构的治疗区域。
一旦可扩张植入物306已递送到脉管结构的治疗区域附近的区域,则主联接构件334可与单套管304脱开,从而允许可扩张植入物306扩张到中间构造。可将可扩张植入物306定向和调整(例如,通过弯曲和扭转转动)到脉管结构的治疗区域内的所需位置。最终定位之后,辅助联接构件324可与单套管304脱开,且可扩张植入物306可扩张到扩张构造。
尽管已讨论了约束构件(例如,主约束构件和辅助约束构件)和套管(例如,主套管和辅助套管)的多种具体构造,但采用任何数量的约束构件和任何数量的套管和/或构造均在本发明的范围内。
在各实施例中,导管组件还包括转向线。在这些构造中,可对转向线施加张力以使转向线移位并使可扩张植入物弯曲。在各实施例中,可扩张装置相对于导管组件的弯曲程度与转向线的位移量成比例。使可扩张植入物弯曲可主要允许植入物符合患者脉管结构内的曲率。其还可有助于行进穿过脉管结构的弯曲区域。
例如,参照图2A-2B,转向线220从患者体外穿过导管杆202,并可释放地联接到可扩张植入物206。在这些构造中,转向线220可穿过可扩张植入物206,以使得从患者体外施加到转向线220的张力致使可扩张植入物206以所需方式弯曲。
又例如,参照图6,示出可扩张植入物606。转向线620沿可扩张植入物606的表面穿过。
在各种实施例中,转向线220可包括金属、聚合物或天然材料,并可包括传统医疗级别的材料,诸如尼龙、聚丙烯酰胺、聚碳酸酯、聚乙烯、聚甲醛、聚甲基丙烯酸甲酯、聚丙烯、聚四氟乙烯、聚三氟氯乙烯、聚氯乙烯、聚氨酯、弹性体有机硅聚合物、诸如不锈钢、钴铬合金和镍钛诺的金属。此外,转向线220也可由高强度聚合物纤维、诸如超高分子量聚乙烯纤维(例如,Dyneema等)或者芳纶纤维(例如等)制成。但是,可用于使可扩张植入物弯曲和/或转向的任何材料均在本发明的范围内。
参照图7A-H,示出各种可扩张植入物构造的剖视图。在各实施例中,可扩张植入物可包括由套管704所围绕的支架705和移植物构件707。在这些构造中,转向线720可以各种不同型式穿过支架705、移植物构件707和/或套管704。这些型式除了其它益处之外可便于通过从体外对转向线720施加张力(和其相应位移)来使可扩张植入物弯曲。此外,这些型式可通过限制或防止“弓弦现象”而减少或防止转向线720损伤患者脉管内的组织。当细丝或线沿可扩张移植物内的曲线内侧上的两点之间的直线行进时会发生弓弦现象。这会造成细丝或线与脉管内的组织接触并可能损伤该组织。也可通过套管704来使弓弦现象和其对组织的影响降低和/或最小,这是因为在弯曲期间且在可扩张植入物完全扩张之前套管704围绕转向线720。
如图7B-7H所示,转向线720可编织穿过支架705、移植物构件707以及套管704的任何组合。在下述每个附图中,示出了一段型式。转向线能以这些型式中的任何组合编织在支架、移植物构件与套管之间。或者,转向线能以如下方式与可扩张植入物和一个或多个套管相互作用,即,允许转向线720使可扩张植入物以所需方式弯曲。
在图7B中,转向线720穿过套管704的内壁与支架705之间。在图7C中,转向线720穿过支架705的第一顶点751与移植物构件707的外壁之间、穿过第二顶点752与套管704的内壁之间、延伸进入并穿过移植物构件707的壁、再进入移植物构件707、穿过支架705的第三顶点753与套管704的内壁之间、并穿过第四顶点754与套管704的内壁之间。在图7D中,转向线720穿过第一顶点751与移植物构件707的外壁之间、第二顶点752与套管704的内壁之间。
在图7E中,转向线720穿过第一顶点751与移植物构件707的外壁之间、延伸穿过移植物构件707的外壁、重新进入移植物构件707、并穿过第三顶点753与移植物构件707的外壁之间。在图7F中,转向线720穿过移植物构件707的外壁与支架705之间。
在图7G中,转向线720从移植物构件707的内壁、在第一顶点751与第二顶点752之间穿到移植物构件707的外壁、返回穿过到移植物构件707的外壁、并在第三顶点753与第四顶点754之间返回穿到移植物构件707的内壁。在图7H中,转向线720抵靠移植物构件707的内壁设置。如前所述,图7B-7G示出转向线可与可扩张植入物相互作用的示例型式。转向线与可扩张植入物相互作用以促进植入物弯曲的任何方式均在本发明范围内。
在各实施例中,导管组件可包括多于一个转向线。例如,参照图9,导管组件900包括两根转向线920。如关于图7A-7G所描述的,转向线920可编织穿过可扩张植入物906的表面。在各实施例中,转向线920可在可扩张植入物906的近端附近离开导管杆902,并与可扩张植入物906配合。在这些构造中,转向线920从近端向远端穿过可扩张植入物的表面,并大致保持与可扩张植入物906的表面接触。然后,转向线920可与可扩张植入物906的表面脱开并变为固定到导管组件900。但,多根转向线920可与可扩张植入物906的任何部分干涉,这些部分包括近端、远端、以及两端之间的任何部分。
在各实施例中,各转向线920以便于可扩张植入物906可控弯曲的型式穿过可扩张植入物906的表面并与该表面相互作用。例如,如图9所示,各转向线920可穿过可扩张植入物906的表面,从而跨越可扩张植入物906的主要部分,两个转向线920彼此平行且彼此靠近。这种构造允许施加到转向线920的张力共同作用以在可扩张植入物906的同一段中形成弯曲或曲率。允许可扩张植入物906选择性且可控弯曲的转向线920以及可扩张植入物906表面的任何构造均在本发明范围内。
在各实施例中,各转向线可横过跨可扩张植入物表面和/或通过可扩张植入物表面的路径,该路径至少部分平行于一个或多个套管并基本上由一个或多个套管覆盖。
在各种实施例中,导管组件还可包括锁定线。在这些实施例中,锁定线可将转向线固定到导管组件。例如,参照图8,导管组件800包括导管杆802、可扩张植入物806、两根转向线820以及锁定线880。锁定线880从患者体外穿过导管杆802。锁定线880离开导管杆802的侧端口、与转向线820配合,然后重新进入导管杆802并持续到导管末端818。在这种构造中,锁定线880将转向线820可释放地联接到导管组件800。锁定线880可与转向线820相互作用以保持转向线820与导管组件800之间可释放联接的任何方式均在本发明范围内。
在各实施例中,每根转向线还可包括端部环。例如,参照图9,每根转向线920包括端部环922。锁定线980可穿过每个端部环922,从而将每根转向线920固定到导管组件900。将转向线920固定到导管组件900的任何方法均在本发明范围内。
在各种实施例中,锁定线980可由金属、聚合物或天然材料制成,并可包括传统医疗级别的材料,诸如尼龙、聚丙烯酰胺、聚碳酸酯、聚乙烯、聚甲醛、聚甲基丙烯酸甲酯、聚丙烯、聚四氟乙烯、聚三氟氯乙烯、聚氯乙烯、聚氨酯、弹性体有机硅聚合物、诸如不锈钢、钴铬合金和镍钛诺的金属。此外,锁定线980也可由高强度聚合物纤维,诸如超高分子量聚乙烯纤维(例如,、Dyneema 等)或者芳纶纤维(例如等)制成。可提供与导管组件900的足够配合并将转向线920固定到导管组件900的任何材料均在本发明范围内。
在各实施例中,用于递送可扩张植入物的导管组件包括导管杆、可扩张植入物、一个或多个套管、一根或多根转向线以及锁定线。在这些构造中,可扩张植入物能够通过施加到一根或多根转向线的张力弯曲并能作相应位移,以符合患者脉管结构内的曲率。
例如,参照图5A-D,示出导管组件500包括可扩张植入物506。导管组件500还包括两根转向线520、锁定线580、主联接构件524以及辅助联接构件534。主联接构件524可释放地联接到主套管504。辅助联接构件534可释放地联接到辅助套管508。
导管组件500插入患者脉管结构内,且可扩张植入物506行进到脉管结构的治疗区域。在到达靠近治疗区域的位置时,主联接构件524可与主套管504脱开,从而允许可扩张植入物506扩张到中间构造。在各实施例中,一旦主联接构件524已脱开,套管504可从脉管移除。
参照图5B,在扩展到中间构造时,可将张力施加到转向线520,从而使可扩张植入物506以所需方式弯曲。例如,可扩张植入物506可沿与转向线520的位置对准的方向弯曲。一旦可扩张植入物506已充分弯曲,则对转向线520施加一致张力以保持弯曲程度。
在各实施例中,可通过从患者体外牵拉转向线而将张力施加到转向线520。在其它实施例中,转向线520可连接到一个或多个拨盘或其它机构以在导管杆502的尾端施加张力。在该构造中,可使用拨盘来施加任何所需张力,以及一旦已经达到可扩张植入物506的所需弯曲角度则保持正确的张力量。各实施例还可包括表明转向线的张力大小或位移量和/或可扩张植入物506中弯曲量的指示、刻度、梯度等。在各实施例中,导管组件可包括允许使用者确定转向线相对于脉管结构的定向的一个或多个附加标记(例如在手柄上)。
在可扩张植入物506中已实现足够的弯曲程度之后,可转动植入物以最终定位在脉管的治疗区域内。在各示例实施例中,锁定线580与转向线520配合,使得导管杆的扭转引起可扩张植入物506在脉管结构内转动。但,允许可扩张植入物506转动的导管组件500的任何构造均在本发明范围内。
在各实施例中,可扩张植入物还可包括一个或多个不透辐射标记。在一实施例中,一个或多个不透辐射标记形成围绕可扩张植入物的远端的带。在其它实施例中,一个或多个不透辐射标记可嵌入套管、诸如是主套管或辅助套管内。此外,一个或多个不透辐射标记可嵌入导管杆。在这些构造中,不透辐射标记可通过在用诸如X射线机器的射线成像装置观察可扩张植入物时提供增加的可见性来辅助可扩张植入物的展开。辅助可扩张植入物展开的不透辐射标记的任何布置均在本发明范围内。
在各实施例中,不透辐射标记可通过提供可扩张植入物的远端或近端的轮廓视图来辅助将可扩张植入物定向。例如,参照图4,示出可扩张植入物406的远端和/或近端的多个可能轮廓491-495。在这些构造中,位于可扩张植入物406的远端和/或近端内的不透辐射标记提供当由射线成像装置观察时可扩张植入物406的端部的轮廓视图。这些轮廓视图可用于通过辅助使用者确定可扩张植入物406中弯曲部的转动角度和/或定向来用于将可扩张植入物406适当定向。
例如,轮廓491表示可扩张植入物406的远端具有大致垂直于诸如X射线摄像头的射线成像图像捕获装置的定向。轮廓492表示可扩张植入物的远端具有相比轮廓491稍不垂直的定向。轮廓493表示可扩张植入物406的远端具有相比轮廓492更不垂直的定向。最后,轮廓494表示可扩张植入物406的远端具有平行于射线成像图像捕获装置的定向。
在可扩张植入物506已适当定向且位于患者的治疗区域内之后,可将辅助联接构件534与辅助套管508脱开。一旦辅助联接构件534与辅助套管508脱开,则可扩张植入物506可在治疗区域内扩张到最终位置和直径。在各示例实施例中,将辅助套管508从脉管移除。在其它各示例实施例中,辅助套管508周向围绕可扩张植入物506的一部分保持就位。
参照图5C,在可扩张植入物506在脉管内就位和扩张之后,锁定线580可与导管组件500脱开。在各实施例中,锁定线580通过从患者体外施加足够张力而脱开。在锁定线脱开之后,转向线520可释放与导管杆502的联接,并可从可扩张植入物506和导管组件500移除。
如图5D所示,在主联接构件524和辅助联接构件534、转向线520以及锁定线580从导管组件500移除之后,导管组件500与可扩张植入物506完全脱开,并可从患者的脉管移除。
本领域的技术人员显然可作出更改和变化而不偏离由所附权利要求书限定的本发明的精神和范围。本发明覆盖落入由所附权利要求书和其等同物范围内提供的本公开的更改和变型。
同样,前面的描述中已经阐述了多个特征和优点,包括各种备选方案以及装置和/或方法的结构和功能的细节。本公开仅表示示例性的且同样并不表示为排它性的。对于本领域的技术人员来说显然可在本发明的原理范围内在所附权利要求书所表达术语的宽泛上位含义所指示的最大范围内进行各种改型,尤其是在结构、材料、元素、部件、形状、尺寸和部件的布置。在这些各种改型不偏离所附权利要求书精神和范围的程度上,它们也意味着包含于此。
Claims (14)
1.一种导管组件,包括:
导管,所述导管具有前端和尾端并包括在所述前端与所述尾端之间延伸的主内腔;
可扩张装置,所述可扩张装置定位在所述导管的所述前端处,所述可扩张装置具有近端和远端、用于所述可扩张装置腔内递送到治疗部位的塌缩构造、以及直径大于所述塌缩构造的直径的扩张构造;以及
转向线,所述转向线延伸穿过所述导管的所述主内腔,所述转向线从所述可扩张装置的所述近端到其远端穿过所述可扩张装置的表面布置并且保持基本上与所述表面接触,并可释放地联接到所述可扩张装置的至少一部分并设置在所述可扩张装置的至少一部分内,以允许所述可扩张装置的选择性弯曲,
周向缠绕在所述可扩张装置周围的主套管,其中所述主套管包括具有第一主表面和第二主表面和从所述第一主表面延伸到所述第二主表面的多个开口的材料片;以及
主联接构件,所述主联接构件与所述多个开口协作以将材料片的各部分彼此可释放地联接,以将所述可扩张装置约束到所述塌缩构造。
2.如权利要求1所述的导管组件,其特征在于,还包括辅助套管和辅助联接构件,所述辅助套管将所述可扩张装置的扩张限于中间构造,所述中间构造的直径大于所述塌缩构造的直径且小于所述扩张构造的直径。
3.如权利要求1所述的导管组件,其特征在于,所述可扩张装置包括支架移植物。
4.如权利要求3所述的导管组件,其特征在于,所述支架移植物包括至少一个顶点,且其中所述转向线编织穿过所述支架移植物的至少一个顶点。
5.如权利要求1所述的导管组件,其特征在于,所述转向线是可移除的。
6.如权利要求1所述的导管组件,其特征在于,还包括锁定线,所述锁定线延伸穿过所述主内腔,其中所述锁定线可释放地配合所述转向线,并将所述转向线联接到所述导管。
7.如权利要求2所述的导管组件,其特征在于,所述转向线设置在所述辅助套管内,使得当所述导管组件插入脉管时,所述转向线不与所述脉管内的组织直接接触。
8.如权利要求1所述的导管组件,其特征在于,所述可扩张装置相对于所述导管的轴线能弯曲大于约90度。
9.如权利要求1所述的导管组件,其特征在于,所述可扩张装置相对于所述导管轴线的弯曲程度与所述转向线上的张力大小成比例。
10.如权利要求1所述的导管组件,其特征在于,在所述可扩张装置展开到所述扩张构造时,所述可扩张装置基本上保持所需弯曲程度。
11.如权利要求1所述的导管组件,其特征在于,所述转向线连接到所述可扩张装置的所述近端和所述远端中的一个。
12.如权利要求1所述的导管组件,其特征在于,所述转向线扭转地锚定所述可扩张装置,且所述导管允许装置在所述治疗部位处经由所述导管的转动而转动定位。
13.如权利要求2所述的导管组件,其特征在于,还包括第一辅助联接构件和第二辅助联接构件,其中所述第一辅助联接构件沿所述辅助套管的长度的约一半穿过,且所述第二辅助联接构件沿所述辅助套管的约另一半穿过。
14.如权利要求1所述的导管组件,其特征在于,还包括辅助联接构件和多个辅助开口,所述辅助联接构件与多个辅助开口协作,以将所述材料片的各部分彼此可释放地联接,以将所述可扩张装置约束在中间构造下,所述中间构造的直径大于所述塌缩构造且小于所述扩张构造。
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US13/658,597 US9782282B2 (en) | 2011-11-14 | 2012-10-23 | External steerable fiber for use in endoluminal deployment of expandable devices |
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PCT/US2012/061928 WO2013074266A1 (en) | 2011-11-14 | 2012-10-25 | External steerable fiber for use in endoluminal deployment of expandable devices |
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CN201280055692.9A Active CN103930075B (zh) | 2011-11-14 | 2012-10-25 | 用于可扩张装置的腔内展开的外部可转向纤维 |
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- 2012-10-23 US US13/658,597 patent/US9782282B2/en active Active
- 2012-10-25 AU AU2012337259A patent/AU2012337259A1/en not_active Abandoned
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- 2012-10-25 BR BR112014011468A patent/BR112014011468A2/pt not_active Application Discontinuation
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JP2014533189A (ja) | 2014-12-11 |
CA2854127C (en) | 2018-01-02 |
JP6306511B2 (ja) | 2018-04-04 |
US20170367859A1 (en) | 2017-12-28 |
CN106859822B (zh) | 2019-07-23 |
EP2779959A1 (en) | 2014-09-24 |
RU2014124125A (ru) | 2015-12-27 |
US20130123896A1 (en) | 2013-05-16 |
EP3278771B1 (en) | 2024-04-17 |
US20220211525A1 (en) | 2022-07-07 |
EP4360598A3 (en) | 2024-07-17 |
EP2779959B1 (en) | 2017-10-04 |
EP3278771A1 (en) | 2018-02-07 |
HK1248517A1 (zh) | 2018-10-19 |
CA2854127A1 (en) | 2013-05-23 |
AU2015207853A1 (en) | 2015-08-20 |
US11324615B2 (en) | 2022-05-10 |
WO2013074266A1 (en) | 2013-05-23 |
CN103930075A (zh) | 2014-07-16 |
AU2012337259A1 (en) | 2014-04-24 |
KR20140096305A (ko) | 2014-08-05 |
US9782282B2 (en) | 2017-10-10 |
HK1202046A1 (zh) | 2015-09-18 |
AU2015207853B2 (en) | 2017-07-27 |
EP4360598A2 (en) | 2024-05-01 |
BR112014011468A2 (pt) | 2017-05-09 |
ES2651187T3 (es) | 2018-01-24 |
CN106859822A (zh) | 2017-06-20 |
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