CN106344208B - 在可扩张装置的腔内部署中使用的外部可转向纤维 - Google Patents
在可扩张装置的腔内部署中使用的外部可转向纤维 Download PDFInfo
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- A61F2/02—Prostheses implantable into the body
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- 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
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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
- A61F2/958—Inflatable balloons for placing 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
- A61F2/95—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
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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
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
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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
- 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
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
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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
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- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
Abstract
本发明描述了利用可扩张植入物治疗患者的脉管系统。所述植入物由至少一个套管约束到用于在脉管系统内递送的缩小的递送直径。所述植入物可被约束到其它直径,例如中间直径。套管可通过从患者的身体外部使联接构件从一个或多个套管脱开而扩张,以允许所述可扩张植入物的直径扩张。所述可扩张植入物可包括一个或多个转向线,转向线有利于所述可扩张植入物穿过患者的脉管系统的弯曲和转向。
Description
本申请是国际申请号为PCT/US2013/022404,国际申请日为2013年01月21日,进入中国国家阶段的申请号为201380013682.3,名称为“在可扩张装置的腔内部署中使用的外部可转向纤维”的发明专利申请的分案申请。
相关申请的交叉引用
本申请要求名称为“EXTERNAL STEERABLE FIBER FOR USE IN ENDOLUMINALDEPLOYMENT OF EXPANDABLE DEVICES”(在可扩张装置的腔内部署中使用的外部可转向纤维)且提交于2012年3月13日的美国临时申请序列号61/610,372的优先权,该申请全文以引用方式并入本文中。
背景
技术领域
本发明大体上涉及腔内装置,并且更具体地涉及在患者的脉管系统内可转向的可扩张的腔内装置。
相关领域的讨论
腔内治疗通常涉及递送导管的插入以将可植入的假体装置通过在远处血管中的小的(常常为经皮的)进入部位输送到脉管系统中。一旦实现到脉管系统的通路,递送导管就被用来通过若干种技术中的一种调节装置的腔内递送和后续展开。以这种方式,装置可被远程植入以获得治疗结果。相比常规外科治疗,腔内治疗的特征是它们的“最小侵入性”特点。
可扩张的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。它们可被设计成在约束物被移除时从其递送直径通过一系列中间直径囊体扩张或囊体扩张成最大的预定功能直径。
一直希望提供用于可扩张的腔内装置向血管治疗部位的腔内递送和部署的改进的系统。
附图说明
本说明书附图被包括以提供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,并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和图2B示出具有可扩张植入物的导管组件的立体图;
图3A-3B和图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4A-4D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;
图9示出具有可扩张植入物的导管组件的侧视图;
图10A示出具有可扩张植入物的导管组件的侧视图;
图10B-10D分别示出图10A中所示可扩张植入物和转向线的内曲线、外曲线和展开视图;以及
图11A-11B示出具有转向线的可扩张植入物的附加实施例。
具体实施方式
本领域的技术人员将容易地理解到可以通过构造成实现所需功能的任意数量的方法和设备来实现本发明的各个方面。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。最后,尽管本发明可结合各种原理和理念来描述,但本发明不应受理论的限制。
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“近侧地”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。
进一步考虑到术语近侧的和远侧的,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窄地理解。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,其利用一个或多个挠性套管,所述套管:(i)将诸如可扩张的腔内支架移植物的可扩张植入物向一尺寸可释放地约束,该尺寸适于将植入物腔内递送到诸如患者身体中的血管构件之类的治疗部位;并且(ii)将植入物进一步约束到这样的外周尺寸:该外周尺寸大于适合腔内递送的尺寸,但小于无约束的或完全展开的外周尺寸,从而有利于在植入物的完全展开和扩张之前在治疗部位处选择性轴向和/或旋转定位或以其它方式操纵该植入物。
本发明的各种实施例包括导管组件,其被构造成将可扩张植入物递送到患者的脉管系统的治疗区域。根据多个实施例,导管组件包括至少一个转向线,其允许可扩张植入物在脉管系统内的选择性弯曲。
首先参照图1,根据本发明的导管组件100包括可扩张植入物106。可扩张植入物106可包括适合递送到脉管系统的治疗区域的任何腔内装置。此类装置可包括例如支架、移植物和支架移植物。因此,可扩张植入物可包括一个或多个支架部件,支架部件具有设置在支架上方和/或下方的一个或多个移植物构件,移植物构件可从递送直径经过一系列更大的中间直径并且朝最大的预定功能直径扩开。
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,并且如下文所讨论的,(多个)支架部件和(多个)移植物构件的任何合适组合在本发明的范围内。
例如,支架部件可具有各种构型,例如,环、切割管、卷绕线材(或带状物)或卷成管状形式的平坦图案化片材。支架部件可由金属、聚合物或天然材料形成,并可包括常规的医用级材料,例如尼龙、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;金属,例如不锈钢、钴铬合金和镍钛诺;以及生物衍生的材料,例如牛动脉/静脉、心包膜和胶原。支架部件也可包括可生物吸收的材料,例如聚(氨基酸)、聚(酐)、聚(己内酯)、聚(乳酸/乙醇酸)聚合物、聚(羟基丁酸盐)和聚(原酸酯)。可由导管递送的任何可扩张的支架部件构型都是根据本发明的。
此外,用于移植物构件的潜在材料包括例如扩张型聚四氟乙烯(ePTFE)、聚酯、聚氨酯、诸如全氟弹性体(perfouorelastomer)等的含氟聚合物、聚四氟乙烯、硅树脂、尿烷、超高分子量聚乙烯、芳纶纤维以及它们的组合。移植物构件材料的其它实施例可包括高强度聚合物纤维,例如,超高分子量聚乙烯纤维(例如Dyneema等)或芳纶纤维(例如等)。移植物构件可包括生物活性剂。在一个实施例中,ePTFE移植物包括沿其血液接触表面的碳成分。可由导管递送的任何移植物构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剂涂层。在这些实施例中,支架部件和/或移植物构件的内部和/或外部可涂有例如CD34抗原。另外,许多药物或治疗剂可用来涂布移植物构件,包括例如肝素、西罗莫司、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(Biolimus)A9、抗CD34抗体、PDGF受体阻滞剂、MMP-1受体阻滞剂、VEGF、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、多西环素、以及沙利度胺等等。
在各种实施例中,可扩张植入物106可包括适合递送到患者的脉管系统的治疗区域的径向塌缩构型。可扩张植入物106可朝径向塌缩构型约束并且可释放地安装到诸如导管轴杆102的递送装置上。可扩张植入物106在塌缩构型中的直径小到足以将植入物通过脉管系统递送到治疗区域。在各种实施例中,塌缩构型的直径足够小以使导管组件100的横截面轮廓最小化并且减少或防止对患者的组织损坏。在塌缩构型中,可扩张植入物106可由导管轴杆102引导通过脉管系统。
在各种实施例中,可扩张植入物106可包括适合将装置植入患者的脉管系统的治疗区域中的径向扩张构型。在扩张构型中,可扩张植入物106的直径可与待修复血管大约相同。在其它实施例中,可扩张植入物106在扩张构型中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可包括可自扩张装置,例如可自扩张支架移植物。此类装置在无约束时从径向塌缩构型扩大至径向扩张构型。在其它实施例中,可扩张植入物106可包括在诸如囊体的辅助装置的帮助下扩张的装置。在另一些其它实施例中,导管组件100可包括多个可扩张植入物106。导管组件与任何数目的可扩张植入物一起使用均在本发明的范围内。
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物装置约束在塌缩构型以将植入物腔内递送至患者的脉管系统的治疗部分。就本发明的目的而言,术语“约束”可表示(i)通过自扩张或者装置帮助来限制可扩张植入物的直径的扩张;或者(ii)覆盖或围绕但除此之外不限制可扩张植入物(例如,出于储存或生物相容性原因和/或为了向可扩张植入物和/或脉管系统提供保护)。例如,导管组件100包括套管104,该套管朝缩小的直径或塌缩构型围绕和约束可扩张植入物106。
在部署之后,一个或多个套管可被移除,以便允许可扩张植入物朝功能直径扩张,并获得所需的治疗结果。备选地,一个或多个套管可保持联接到植入物或以其它方式植入,同时不妨碍可扩张植入物。
在各种实施例中,可扩张植入物由周向地围绕可扩张植入物的单个套管来约束。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周向地围绕可扩张植入物206并且将在朝塌缩构型约束,在该塌缩构型中,直径小于无约束或者以其它方式部署的植入物的直径。例如,套管204可朝塌缩构型约束可扩张植入物206以在脉管系统内递送。
在其它实施例中,可扩张植入物由周向地围绕可扩张植入物的多个套管约束,这些套管允许可扩张植入物部署和保持在大于塌缩构型且小于部署构型的中间构型中。多个套管可包括彼此周向地围绕的至少两个套管。
在各种实施例中,套管可以是管状的并且用来约束可扩张植入物。在这样的构型中,套管由包裹或折叠在可扩张植入物周围的一种或多种材料片形成。虽然本文的示例性实施例描述为包括一个或多个管状套管,但对应于下置的可扩张植入物或为了给定的应用而以其它方式适当地成形的任何非管状形状的套管也在本发明的范围内。
在各种实施例中,通过包裹或折叠(多种)材料片使得该材料片的两个平行边缘基本上对齐来形成套管。所述对齐可以或可以不平行于导管组件的导管轴杆或与导管轴杆同轴。在各种实施例中,(多种)材料片的边缘彼此不接触。
在各种实施例中,(多种)材料片材的边缘彼此接触并且通过粘合剂等与联接构件(如下所述)联接。在各种其它实施例中,(多种)材料片材的边缘对齐,zi以使得一个或多个片材的相同侧(例如,片材的前面或后面)的边缘彼此接触。在另一些其它实施例中,(多种)材料的片材的相对侧的边缘彼此接触,以使得这些边缘彼此重叠,使得片材的一侧的一部分与另一侧的一部分接触。换句话讲,片材的前面可与片材的后面重叠,反之亦然。
在各种实施例中,套管包括类似于用来形成移植物构件的那些材料。例如,用来制造套管的前体挠性片材可由平的薄壁ePTFE管形成。薄壁管可结合呈附连到或嵌入片材或管壁中的纵向高强度纤维形式的“防裂开件”。
用来形成(多个)套管的(多种)材料的片材可包括一系列开口,使得所述开口从片材的一个边缘延伸至另一个边缘。在这样的构型中,联接构件可通过(多种)材料的片材中的所述一系列开口而被织造或缝合,从而将两个边缘中的每一个固定在一起并形成管。例如,在图1中,联接构件124将套管104的边缘固定,使得套管104朝适合腔内递送的减小的直径或外周尺寸保持可扩张植入物106。
在各种实施例中,联接构件可包括织造纤维。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形状的任何类型的线丝、绳、线、纤维或线材都在本发明的范围内。
在各种实施例中,单个联接构件可用来约束一个或多个套管的直径。在其它实施例中,多个联接构件可用来约束一个或多个套管的直径。
一旦合适的可扩张植入物处于塌缩构型,可扩张植入物就可部署在患者的脉管系统内。处于塌缩构型的可扩张植入物可被引入到脉管系统并由导管组件引导至脉管系统的治疗区域。一旦在脉管系统的治疗区域中就位,可扩张植入物就可扩张至扩张构型。
当可扩张植入物在脉管系统内就位时,一个或多个联接构件可从患者身体外部与一个或多个套管脱开,这允许(多个)套管打开并允许可扩张植入物扩张。如上文所讨论的,可扩张植入物可以是自扩张的,或者植入物可由诸如囊体的扩张装置扩张。
一个或多个联接构件可由从患者身体外部操作的机械机构、从一个或多个套管脱开。例如,可通过将足够的张力施加到一个或多个构件来脱开所述一个或多个构件。在另一示例中,可平移元件可在身体外部附连到一个或多个联接构件。可平移元件的移位(例如刻度盘或旋转构件的旋转或手柄或捏手部的平移)可提供足够的张力以使一个或多个联接构件移位或脱开。
在各种实施例中,使闭合单个套管的单个联接构件从套管脱开允许可扩张装置朝更大直径或外周尺寸扩张。例如,参照图2A,导管组件200可用来将植入的可扩张植入物206递送至脉管系统的治疗区域。可扩张植入物206具有用于递送的塌缩直径,并且套管204周向地围绕可扩张植入物206并由联接构件224保持闭合。如下文更详细描述的,在完全扩张之前(例如,在中间直径处)可控制可扩张植入物206的弯曲,以有助于方便向所需位置的递送。一旦可扩张植入物206相对于治疗区域就位,联接构件224就从套管204脱开并且套管204被释放,以允许可扩张植入物206朝更大直径扩张。
如上文所提及的,在本发明的各种实施例中,可扩张植入物还可包括中间构型。在中间构型中,可扩张植入物的直径被约束在小于扩张构型但大于塌缩构型的直径。例如,可扩张装置在中间构型的直径可以是可扩张装置在扩张构型的直径的约50%。然而,小于扩张构型的直径且大于塌缩构型的中间构型的任何直径都在本发明的范围内。
在这样的实施例中,一旦植入物已被递送到患者的脉管系统的治疗区域附近,可扩张植入物就可从塌缩构型朝中间构型扩张。中间构型主要可以帮助将可扩张植入物适当地定向和定位在脉管系统的治疗区域内。
在各种实施例中,可扩张植入物可由具有不同直径的两个套管同心地围绕。在这样的构型中,主套管朝塌缩构型约束可扩张植入物。一旦塌缩构型套管打开,副套管就朝中间构型约束可扩张植入物。如上文所讨论的,可扩张植入物可以是自扩张的,或者植入物可由诸如囊体的装置扩张。
例如,参照图2A,导管组件200包括可扩张植入物206和套管204。副套管204朝中间构型约束可扩张植入物206。副套管204通过副联接构件224围绕可扩张植入物206保持就位。
导管组件200还包括主套管208,其朝塌缩构型约束可扩张植入物206以递送至患者的脉管系统。主套管208通过主联接构件234围绕可扩张植入物206保持就位。
一旦可扩张植入物206充分地接近脉管系统的治疗区域,主联接构件234就从主套管208脱开,这释放主套管208并允许扩张的植入物206朝更大直径扩张。
参照图2B,在主套管208已扩张之后,副套管204中间构型朝约束可扩张植入物206。在中间构型中,如上文所提及的并且如下文更详细地描述的,可扩张植入物206可被定向和调整(例如,通过弯曲和扭转)至脉管系统的治疗区域内的所需位置。
在本发明的其它实施例中,单个或“单”套管可用来将可扩张植入物约束在塌缩构型和中间构型中。例如,参照图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、以及副联接构件324。
单套管304还包括多个副孔332。在该构型中,副联接构件324通过副孔332被缝合或织造,从而将单套管304和可扩张植入物306收紧到中间构型的直径。在中间构型中,可扩张植入物306的直径小于扩张的直径并且大于塌缩构型的直径。在中间构型中,如下文更详细描述的,可扩张植入物306可被定向和调整(例如,通过弯曲和扭转)至脉管系统的治疗区域内的所需位置。
单套管304还包括多个主孔330。在该构型中,主联接构件334通过主孔330被缝合或织造,从而将单套管304和可扩张植入物306朝塌缩构型收紧。塌缩构型的直径或外周尺寸选择成允许使可扩张植入物306腔内递送到患者的脉管系统的治疗区域。
一旦可扩张植入物306已被递送到脉管系统的治疗区域附近的区域,主联接构件334就可从单套管304脱开,从而允许可扩张植入物306朝中间构型扩张。可扩张植入物306可被定向和调整(例如,通过弯曲和扭转)至脉管系统的治疗区域内的所需位置。在最终定位之后,副联接构件324可从单套管304脱开,并且可扩张植入物306可朝扩张构型扩张。
虽然已讨论了约束构件(例如,主构件和副构件)和套管(例如,主套管和副套管)的多个具体构型,但任意数目和/或构型的约束构件和任意数目的套管的使用都在本发明的范围内。此外,可通过分别使副联接构件和主联接构件从单套管部分地、选择性地脱开而允许可扩张植入物朝中间构型和扩张构型部分地扩张。
在各种实施例中,导管组件还包括转向线。在这样的构型中,可将张力施加到转向线以使转向线移位,并弯曲可扩张植入物。弯曲可扩张植入物主要可帮助行进通过脉管系统的弯曲或曲折区域。弯曲可扩张植入物也可允许植入物顺应于患者的脉管系统中的曲率。
例如,参照图2A-2B,转向线220从患者的身体外部通过导管轴杆202,并且可释放地联接到可扩张植入物206。在这样的构型中,转向线220可穿过可扩张植入物206,以使得从患者的身体外部施加到转向线220的张力造成可扩张植入物206以所需方式弯曲。
作为另一示例,参照图6,示出了可扩张植入物606。转向线620沿可扩张植入物606的表面穿引。
在各种实施例中,转向线220可包括金属、聚合物或天然材料,并可包括常规的医用级材料,例如,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;金属,例如不锈钢、钴铬合金和镍钛诺。细长构件或锁定线也可由高强度聚合物纤维形成,例如,超高分子量聚乙烯纤维(例如,Dyneema等)或芳纶纤维(例如,等)。
参照图7A-H,示出了各种可扩张植入物构型的剖视图。在各种实施例中,可扩张植入物可包括由套管704围绕的支架705和移植物构件707。在这样的构型中,转向线720可以多种不同的样式穿过支架705、移植物构件707和/或套管704。除了其它益处之外,这样的样式可通过将张力从身体外部施加到转向线720(和其对应的移位)而有利于可扩张植入物的弯曲。此外,这样的样式可通过限制或防止“勒紧(bowstringing,弓弦现象)”而减少或防止转向线720损坏患者的脉管系统内的组织。勒紧发生在线丝或线在可扩张移植物中的曲线内部上的两点之间的直线上行进时。这可造成线丝或线与脉管系统中的组织接触并潜在地损坏组织。勒紧和其对组织的效应也可通过套管704来减小和/或最小化,因为套管704在可扩张植入物弯曲期间和可扩张植入物完全扩张之前围绕转向线720。
如图7B-7H所示,转向线720可迂回通过支架705、移植物构件707和套管704的任何组合。在下文描述的每个图中,描述了一段样式。转向线可以这些样式的任何组合在支架、移植物构件和套管之间迂回。备选地,转向线可以允许转向线720以所需方式弯曲可扩张植入物的任何方式与可扩张植入物和一个或多个套管相互作用。
在图7B中,转向线720在支架705和套管704的内壁之间穿过。在图7C中,转向线720在支架705的第一顶点751和移植物构件707的外壁之间穿过,在第二顶点742和套管704的内壁之间穿过,延伸进入和穿过移植物构件707的壁,再次进入移植物构件707,在支架705的第三顶点753和套管704的内壁之间穿过,并且在第四顶点754和套管704的内壁之间穿过。在图7D中,转向线720穿过第一顶点751和移植物构件707的外壁之间、然后穿过第二顶点752和套管704的内壁之间。
在图7E中,转向线720穿过第一顶点751和移植物构件707的外壁之间,延伸穿过移植物构件707的外壁,再次进入移植物构件707,并且穿过第三顶点753和移植物构件707的外壁之间。在图7F中,转向线720穿过移植物构件707的外壁和支架705之间。
在图7G中,转向线720从移植物构件707的内壁传递,在第一顶点751和第二顶点752之间穿引至移植物构件707的外壁,再次穿过至移植物构件707的外壁,并且在第三顶点753和第四顶点754之间再次穿过至移植物构件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。如此前所讨论的,图7B-7G示出转向线可与可扩张植入物相互作用的示例性样式。其中转向线与可扩张植入物相互作用以有利于植入物的弯曲的任何方式都在本发明的范围内。
在各种实施例中,导管组件可包括不止一个转向线。例如,参照图9,导管组件900包括两个转向线920。如结合图7A-7G所述,转向线920可迂回通过可扩张植入物906的表面。在各种实施例中,转向线920可离开导管轴杆902并在可扩张植入物906的近端附近接合可扩张植入物906。在这样的构型中,转向线920可从近端到远端行进横贯可扩张植入物906的表面并与该表面保持基本上接触。然后,转向线920可与可扩张植入物906的表面脱开,并且变得固定到导管组件900。
在各种实施例中,转向线920以有利于可扩张植入物906的可控弯曲的样式横贯可扩张植入物906的表面并与其相互作用。例如,如图9所示,转向线920可横贯可扩张植入物906的表面,以使得横贯可扩张植入物906的相当大一部分,两个转向线920彼此平行且彼此紧邻。这样的构型允许施加到转向线920的张力一起作用以在可扩张植入物906的相同段中形成弯部或弧线。允许可扩张植入物906的选择性的和可控的弯曲的转向线920和可扩张植入物906的表面的任何构型都在本发明的范围内。
在各种实施例中,一个或多个转向线被构造成允许可扩张植入物的选择性的和可控的弯曲,例如如上所述那样,并且还允许可扩张植入物相对于导管组件的非同心临时接合。例如,可能希望可扩张植入物的内表面的一部分在远侧临时接合导管组件。这样的部分例如可以是在可扩张植入物的选择性的和可控的弯曲期间将具有最长曲率半径的部分,而不论是在其递送和部署期间和/或之后。这样的部分可因此为可扩张植入物的外部弯曲部分。
为了实现上述目的,在各种实施例中,一个或多个转向线可沿可扩张植入物的边缘分别始于和结束于远端和近端处,该边缘在选择性的和可控的弯曲期间将具有最长曲率半径。在远端和近端之间,一个或多个转向线可朝可扩张植入物的边缘且沿该边缘转变,该边缘在选择性的和可控的弯曲期间将具有最短曲率半径。
例如,参照图10A,导管组件1000示出为具有导管轴杆1002,导管轴杆1002通过两个转向线1020临时接合到可扩张植入物1006的内表面的外部弯曲部分的远端,每个转向线1020包括螺旋样式。如结合图7A-7G所述,转向线1020可迂回通过可扩张植入物1006的表面。在各种实施例中,转向线1020可离开导管轴杆1002并在可扩张植入物1006的远端附近接合可扩张植入物1006。在这样的构型中,转向线1020可从远端到近端行进横贯可扩张植入物1006的表面并与该表面保持基本上接触。转向线1020可接着与可扩张植入物1006的表面脱开,并且变得固定到导管组件1000。
如图10B-10D所示,这些图分别示出图10A中所示可扩张植入物和转向线的内曲线、外曲线和展开视图,每个转向线1020的螺旋样式始于可扩张植入物1006的外曲线上的远端附近,并且结束于可扩张植入物1006的内曲线上的近端。每个转向线1020在基本上平行于可扩张植入物1006的中心轴线的方向上朝可扩张植入物1006的内曲线上的近端继续,在这里,转向线周向横贯可扩张植入物1006返回至其外曲线。如图10B-10D所示,每个转向线1020的样式相对于穿过可扩张植入物1006的中心轴线的矢状面与另一个转向线呈镜像。以这种方式,转向线1020配合以允许可扩张植入物1006的选择性的和可控的弯曲,并且也允许可扩张植入物1006相对于导管轴杆1002的非同心临时接合。允许可扩张植入物1006的选择性的和可控的弯曲以及非同心的临时接合的可扩张植入物1006的表面和转向线1020的任何构型都在本发明的范围内。
例如并且如图11A所示,转向线1120的螺旋样式在可扩张植入物1106的外曲线上的远端附近始于可扩张植入物1106的外部上,并且结束于可扩张植入物1106的内曲线上的近端。转向线1120在基本上平行于可扩张植入物1106的中心轴线的方向上、于内曲线上并且朝可扩张植入物1106的内曲线上的近端继续。从近端起,转向线1120进入可扩张植入物1106并且在可扩张植入物1106的外曲线处返回到远端,在这里,它被远端销锁定。图11B示出类似的构型,其中类似的张力F被施加到转向线1120,但其中转向线1120以相反构型穿引和锁定。
在各种实施例中,转向线可横贯和/或穿过可扩张植入物的表面的路径,其至少部分地平行于一个或多个套管并且基本上由所述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。在这样的实施例中,锁定线可将一个或多个转向线固定到导管组件。例如,参照图8,导管组件800包括导管轴杆802、可扩张植入物806、两个转向线820、以及锁定线880。锁定线880从患者的身体外部传递通过导管轴杆802,并且在导管顶端818附近的点处离开。在该点处,锁定线与转向线820相互作用,然后再次进入导管轴杆802并且继续到导管顶端818。在这样的构型中,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可与一个或多个转向线820相互作用以保持一个或多个转向线820和导管组件800之间的可释放联接的任何方式都在本发明的范围内。
在各种实施例中,每个转向线还可包括端部环。例如,参照图9,每个转向线920包括端部环922。锁定线980可穿过每个端部环922,以将每个转向线920固定到导管组件900。将一个或多个转向线920固定到导管组件900的任何方法都在本发明的范围内。
在各种实施例中,锁定线可由金属、聚合物或天然材料形成并可包括常规的医用级材料,例如,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;金属,例如不锈钢、钴铬合金和镍钛诺。细长构件或锁定线也可由高强度聚合物纤维形成,例如,超高分子量聚乙烯纤维(例如,Dyneema等)或芳纶纤维(例如,等)。
在各种实施例中,用来递送可扩张植入物的导管组件包括导管轴杆、可扩张植入物、一个或多个套管、一个或多个转向线以及锁定线。在这样的构型中,可扩张植入物能够通过施加到一个或多个转向线的张力和对应的移位而弯曲以适形于患者的脉管系统中的曲率。
例如,参照图5A-D,示出了包括可扩张植入物506的导管组件500。导管组件500还包括两个转向线520、锁定线580、主联接构件524和副联接构件534。主联接构件524可释放地联接到主套管504。副联接构件534可释放地联接到副套管508。
将导管组件500插入患者的脉管系统中,并且使可扩张植入物506前进至脉管系统的治疗区域。在到达靠近治疗区域的位置时,主联接构件524可从主套管504脱开,以允许可扩张植入物506扩张至中间构型。在各种实施例中,一旦主联接构件524已脱开,就可将套管504从脉管系统移除。
参照图5B,在扩张至中间构型时,可将张力施加到转向线520,从而造成可扩张植入物506以期望方式弯曲。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,就将一致的张力施加到转向线520以保持弯曲度。
在各种实施例中,可通过从患者的身体外部拉动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刻度盘或其它机构以在导管轴杆502的尾端处施加张力。在该构型中,刻度盘可用来施加所需的张力,并且一旦实现可扩张植入物506的所需弯曲角度就用来保持正确量的张力。各种实施例也可包括展示转向线的张力大小或移位量和/或在可扩张植入物506中的弯曲量的指示器、刻度、梯度等。在各种实施例中,导管组件可包括一个或多个附加标记(例如,在手柄上),其允许使用者确定转向线相对于脉管系统的取向。
在已在可扩张植入物506中实现足够的弯曲度之后,可转动植入物以最终定位在脉管系统的治疗区域中。在各种示例性实施例中,锁定线580与转向线520接合,以使得导管轴杆的扭转造成可扩张植入物506在脉管系统内转动。然而,允许可扩张植入物506转动的导管组件500的任何构型都在本发明的范围内。
在各种实施例中,可扩张植入物还可包括一个或多个不透辐射标记。在一个实施例中,一个或多个不透辐射标记围绕可扩张植入物的远端形成带。在这样的构型中,通过在用诸如X射线机的射线照相装置观察可扩张植入物时提供增加的可视性,不透辐射标记可有助于可扩张植入物的部署。有助于可扩张植入物的部署的不透辐射标记的任何布置都在本发明的范围内。
在各种实施例中,不透辐射标记可通过提供可扩张植入物的远端的轮廓视图而帮助定向可扩张植入物。例如,参照图4,示出了可扩张植入物406的远端的多种可能的轮廓491-495。在这样的构型中,当由射线照相装置观察时,位于可扩张植入物406的远端中的不透辐射标记提供可扩张植入物406的远端的轮廓视图。这样的轮廓视图可用来通过帮助使用者确定可扩张植入物406中的弯部的旋转程度和/或取向而正确地定向可扩张植入物406。
例如,轮廓491表示具有基本上正交于诸如X射线照相机的射线照相图像捕获装置的取向的可扩张植入物406的远端。轮廓492表示具有没轮廓491那么正交的取向的可扩张植入物的远端。轮廓493表示具有比轮廓492更不正交的取向的可扩张植入物406的远端。最后,轮廓494表示具有平行于射线照相图像捕获装置的取向的可扩张植入物406的远端。
在可扩张植入物506已被正确地定向和定位在患者的治疗区域内之后,副联接构件534可从副套管508脱开。一旦副联接构件534从副套管508脱开,可扩张植入物506就可在治疗区域内扩张至最终位置和直径。在各种示例性实施例中,从脉管系统移除副套管508。在其它示例性实施例中,副套管508保持在周向围绕可扩张植入物506的一部分的位置中。
参照图5C,在可扩张植入物506在脉管系统内就位和扩张之后,锁定线580可从导管组件500脱开。在各种实施例中,通过从患者的身体外部向锁定线580施加足够的张力而使锁定线580脱开。在锁定线580脱开之后,转向线520可从与导管轴杆502的联接被释放,并且从可扩张植入物506和导管组件500移除。
如图5D所示,在主联接构件524和副联接构件534、转向线520以及锁定线580从导管组件500被移除之后,导管组件500从可扩张植入物506完全脱开,并且可从患者的脉管系统移除。
对于本领域技术人员而言,显然可对本发明作出各种改型和变型而不脱离本发明精神或范围。因此,本发明旨在涵盖其任何改型和变型,只要它们落在所附权利要求及其等同物的范围内即可。
同样,前面的描述已经给出了许多特征和优点,包括各种替代的实施方式,以及装置和/或方法的结构和功能的细节。本发明仅仅意图为示例性的,并且因此并非意图详尽列举。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。在这些多种改变不偏离所附权利要求书的精神和范围的程度上,它们属于本发明的范围内。
Claims (14)
1.一种导管组件,包括:
导管;
可扩张装置,所述可扩张装置具有近端和远端,并且布置在所述导管的前端附近;
两根转向线,所述转向线布置成沿周向和纵向跨过所述可扩张装置的外表面横贯所述可扩张装置,所述转向线包括设置在所述可扩张装置的所述外表面的内曲线上的部分和设置在所述可扩张装置的所述外表面的外曲线上的部分,以使得从所述近端到所述远端贯穿所述可扩张装置的矢状面而彼此镜像,其中,每根转向线在所述外曲线上起始的周向位置与其在周向横贯所述可扩张装置后返回所述外曲线的周向位置均相近,所述转向线构造成响应于施加于其的张力而在所述可扩张装置的相同段中形成弯部或弧线。
2.根据权利要求1所述的导管组件,其特征在于,所述转向线构造成沿着所述可扩张装置的近侧部和所述可扩张装置的远侧部中的至少一者形成弯部。
3.根据权利要求1所述的导管组件,其特征在于,所述转向线以螺旋形图案沿着所述可扩张装置的外表面布置。
4.根据权利要求3所述的导管组件,其特征在于,所述转向线的一部分布置成基本上平行于所述可扩张装置的中心轴线。
5.根据权利要求1所述的导管组件,其特征在于,所述可扩张装置构造成径向塌缩成适于递送的塌缩构型,并且扩张到扩张构型。
6.根据权利要求5所述的导管组件,其特征在于,所述转向线能从处于所述扩张构型的所述可扩张装置移除。
7.根据权利要求5所述的导管组件,其特征在于,所述转向线构造成将所述可扩张装置保持在期望的弯曲半径下,而所述可扩张装置展开到所述扩张构型。
8.根据权利要求1所述的导管组件,其特征在于,还包括锁定线,所述锁定线构造成将所述可扩张装置可释放地联接到所述导管。
9.根据权利要求8所述的导管组件,其特征在于,所述锁定线构造成将所述转向线可释放地联接到所述导管。
10.根据权利要求8所述的导管组件,其特征在于,所述转向线扭转地锚固所述可扩张装置和所述导管,以允许通过导管的转动将装置可转动定位在治疗部位处。
11.根据权利要求1所述的导管组件,其特征在于,还包括联接到所述导管的手柄,手柄包括一个或多个标记来向使用者标示所述转向线的定向。
12.根据权利要求11所述的导管组件,其特征在于,所述手柄包括构造成将张力施加到所述转向线的一个或多个机构。
13.根据权利要求1所述的导管组件,其特征在于,所述转向线包括尼龙、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中的至少一种。
14.根据权利要求1所述的导管组件,其特征在于,使所述转向线织造通过所述可扩张装置的至少一部分。
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