CN1917831B - 管状修补物 - Google Patents

管状修补物 Download PDF

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CN1917831B
CN1917831B CN200580004565.6A CN200580004565A CN1917831B CN 1917831 B CN1917831 B CN 1917831B CN 200580004565 A CN200580004565 A CN 200580004565A CN 1917831 B CN1917831 B CN 1917831B
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埃里克·彼鲁兹
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Perouse Medical SAS
Cormove SAS
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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
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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
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
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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
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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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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    • 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
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • 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
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • A—HUMAN NECESSITIES
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    • A61F2230/00—Geometry 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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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

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Abstract

一种可径向变形的管状修补物(10)，其包括能够在小直径的收缩状态和大直径的扩张状态之间变形的格架(12)。该修补物包括至少两个外部钩子(18)，该至少两个外部钩子在它们之间限定出用于钩住外部组织的夹具(16)，所述至少两个外部钩子(18)由格架(12)承载并且能够在其中该夹具(16)打开的分开位置和其中该夹具(16)闭合的关闭位置之间移动，每个钩子(18)从连接端与该格架(12)相连，并且所述夹具(16)的钩子(18)在该修补物变形期间能够彼此相对移动。

Description

管状修补物
技术领域
本发明涉及一种可径向变形的管状修补物(prosthesis)，其包括能够在小直径的收缩状态和大直径的扩张状态之间变形的格架(lattice)。
背景技术
对于各种类型的治疗来说，已知可将管状修补物放置在静脉或动脉的血管内。这种管状修补物通常由术语“扩张器(stent)”表示。
该修补物在其处于收缩状态时放入血管中，随后出于定位的目的，修补物扩张，从而压靠血管的内表面。该扩张或者由于修补物格架的弹性而自动进行，或者在充气的内部气球的驱动下进行，从而导致组成格架的材料的塑性变形。
很难确保修补物在血管内部轴向、即沿血管的长度方向固定，并且修补物存在着在血流驱动下沿血管移动的风险。另外，修补物由于其不规则截面而存在着不能准确压靠在血管表面上的风险。
为了避免这种移动，已知金属格架的端部可以具有适于刺入血管壁以防止修补物轴向移动的向外突出的爪部。
还已知例如通过将夹子放置就位使修补物固定在血管壁上，所述夹子在修补物已经放置就位后安装。
那些紧固装置不是非常可靠，并且它们很难放置就位。
发明内容
本发明的目的在于提供一种管状修补物，其可以可靠地定位，并且可相对容易地放置就位。
为此，本发明提供了一种上述类型的管状修补物，其特征在于，它包括至少两个外部钩子，该至少两个外部钩子在它们之间限定出用于钩住外部组织的夹具，所述至少两个外部钩子由格架承载并且能够在其中该夹具打开的分开位置和其中该夹具闭合的合拢位置之间移动，每个钩子从连接端与该格架相连，并且所述夹具的钩子在该修补物变形期间能够彼此相对移动。
在特定实施例中，该管状修补物包括下列特征中的一项或多项：
所述格架包括形成呈可变形四边形形式的网孔的交叉线材，并且每个钩子在四边形的角上与格架相连；
每个钩子在其连接端处焊接(例如钎焊)到格架上；
每个钩子在其连接端处通过围绕格架扭绞的线束延伸；
所述夹具的每个钩子在其钩端呈现出牧羊杖的形状，所述至少两个外部钩子至少部分地交叠，以便形成所述夹具；
每个钩子呈大致直线叶片的形式，当夹具打开时，所述至少两个外部钩子彼此面对地延伸并彼此分开；以及
格架能够向着其扩张位置弹性变形。
本发明还提供了一种用于处理血管的成套工具，该成套工具的特征在于，其包括：
如上所述的修补物；
用于在该夹具或每个夹具的区域中将该格架保持在收缩状态的装置；以及
格架输送管，其限定出用于将该修补物限制在其收缩状态的限制管道。
在特定实施例中，该输送管的限制管道包括用于容纳该钩子的纵向通道。
附图说明
在参考附图并且阅读下面仅通过举例方式给出的说明的基础上可以更好地理解本发明，其中：
图1为处于扩张状态的管状修补物的透视图；
图2为以放大比例尺显示了在包括夹具的区域内处于扩张状态的修补物的剖视图；
图3A为处于收缩状态的修补物的横截面视图；
图3B为在图3的收缩状态下被植入的修补物的透视图；
图3C为以放大比例尺显示了在包括处于打开位置的夹具的区域内处于收缩状态的修补物的剖视图；
图4A为与图3A类似的视图，显示了在钩住之前扩张的修补物；
图4B为在钩住之前扩张的修补物的透视图；
图5A为与图3A类似的视图，显示了在夹具锁紧件已经缩回之后扩张并钩住的修补物；
图5B为在夹具保持元件已经撤回后扩张的修补物的透视图；以及
图6和7分别为本发明的修补物的不同实施例的透视图和正视图。
具体实施方式
图1显示的管状修补物10用于在血管中放置就位(或放入血管中的适当位置)。该管状修补物包括管状格架12，其基本上在修补物的整个长度上嵌入薄膜14中。在其端部之一的附近，修补物还包括三个在其外周上以一定角度有规律地隔开的夹具16。
每个夹具16由被金属格架12承载的两个钩子18组成。这些钩子可以在夹具打开的分开位置和夹具闭合的合拢位置之间彼此相对移动。
夹具16设置在不具有任何薄膜14的修补物的端部区段20上，格架12因此在该区段未被覆盖。与之相对，以参考标号22表示的修补物的主要区域具有嵌入薄膜14中的格架12。
格架12由具有生物相容性的不锈钢构成。例如，它通过编织或编结线材使一管子轴向扩张或者通过其它任何适宜的技术制成。
在图1所示实施例中，格架12由两束线材沿相反方向螺旋缠绕而成，任何一束中的线材大体上彼此平行地延伸并且与沿相反方向缠绕的线束中的线材交叉。
两个反向缠绕的线束中的线材以交替的方式彼此上下交叉。
格架12优选地可弹性变形，以在小直径收缩状态和大直径扩张状态之间径向扩张。
在其扩张状态下，如图1所示，格架的网孔形成沿周向大体上细长的菱形。与之对照，如图3B中所示，当修补物处于收缩状态时，网孔形成沿平行于修补物的轴线方向细长的菱形。
在一变型中，修补物可塑性变形，即格架具有小直径的第一稳定形状和大直径的第二稳定形状。
在其区段22中，格架12完全嵌入薄膜14中。该薄膜由可拉伸并防止液体侵入的材料构成，并且其填充网孔。
该材料可充分拉伸，以使薄膜14能够遵循格架从其收缩状态向其扩张状态的变形而不会撕裂或松开，并且不管格架的网孔的变形如何。适宜的材料为诸如天然或合成橡胶的生物相容弹性体，或者甚至诸如聚氨酯的生物相容聚合物。
在金属已经被除去油污并利用结合底料(bonding primer)处理后，可以通过共挤法或浸渍法对格架12涂覆薄膜14。
如图2中所示，每个钩子18形成具有自由端的金属线材(金属丝)区段，所述自由端向外弯曲，以形成牧羊杖部24的形状。杖部24延伸出一直线区段26。钩子18至少部分地交叠(或搭接)，以便形成夹具16。
在其与杖部24相对的端部，每个区段26沿网孔的对角通过焊接(例如钎焊)定位焊点(tacking)28焊接到金属格架12上，如图1中所示。杖部24从由格架12限定的管状区段向外突出，并且在静止时，杖部的弯曲端位于横向于管状修补物延伸、即垂直于其总体轴线延伸的平面内，如图2所示。
形成钩子的牧羊杖24的直径在0.5毫米(mm)至4毫米的范围内，而支臂26的长度在3毫米至12毫米的范围内。形成钩子的弯曲端的杖部24的直径优选地为钩子的支臂26的长度的1/4至1/8的范围内。
支臂26的长度如此设置，以使得当修补物处于如图1所示的扩张状态时，钩子18的两个杖部彼此相向地移动并且共同限定出闭合或实质上闭合的环。
最初，如图3A、3B和3C所示，修补物与用于将夹具16保持在打开位置的装置30相连。
另外，其夹具保持打开的修补物以传统方式容纳在输送管32中，修补物在所述输送管内被限制为收缩状态。
有利地，管32的内部管道具有用于容纳钩子18的端部的纵向通道33，所述端部从金属格架的大体管状表面伸出。
如图3B和3C所示，每个用于保持夹具打开的装置包括例如由聚醚醚酮(PEEK)制成的柔性管34。管34在用于容纳在血管中的远端36和设计为使患者体外的外科医生能够接触的近端38之间纵向延伸。因此，管34可以约为1米(m)长。
止动开口40设置在管34的侧部，其通常与相关的夹具16对准。管34在其近端38的附近还安装有中空侧道42，其设有用于轴向锁定滑动绳的环43。
可松开的止动装置30还包括轴向接合在管34中的止动杆44以及围绕承载夹具16的修补物的网孔延伸的止动绳46。
止动杆44从管34的一端向另一端延伸。它从管的近端38向外伸出。
该杆在管34的内部可在杆面向开口40的止动位置和杆44与开口40分开并向着管34的近端偏移的松开位置之间移动。
止动绳46包括具有孔眼48、拉紧环50和沿管34的整个长度从开口向分支连接部42延伸的控制区段52的单根线束，所述控制区段52在穿过锁定环43之后从所述分支连接部伸出。
端部孔眼48由小直径的封闭环构成，杆44在其处于止动位置时穿过该孔眼被初始地接合。拉紧环50由可滑动地穿过与承载夹具16的网孔邻接的所述格架的两个网孔的线束区段形成。
拉紧环穿过开口40，以在一端连接孔眼48并且在另一端连接控制区段52。如下面所解释，拉紧环50的有效长度可作为施加于控制区段52上的牵引力的函数变化，从而使得其控制承载夹具16的网孔的形状。
初始时，在放置就位之前，修补物被放置在输送管32中，并且夹具止动装置的控制区段52在张力作用下使得夹具保持打开，如图3B所示。在该位置，拉紧环50将承载夹具的网孔拉紧，以使得限定出网孔的菱形沿其平行于修补物的轴线的对角线是细长的。
为了将修补物放置就位，其与管32一起插入到输送区域中，并且随后管32被撤回，从而释放修补物。修补物扩张并且随后开始压靠血管的内表面，如图4A和4B所示。
在扩张期间，修补物格架的网孔由于格架的弹性而延伸，从而使得修补物的周向对角线伸长，由此使修补物的直径增大。与之对照，承载夹具的网孔由于拉紧环50而保持收缩，如图4B所示。因此，夹具16在仍然处于打开位置的同时压靠血管的表面。
通过作用于锁定环43，作业者随后开始松开止动绳，从而允许承载夹具的网孔弹性变形，由此使成对的对置钩子彼此相向地移动，使每个夹具闭合，并且使钩子刺入限定出血管的壁中，如图5A和5B所示。
在止动绳46已经松开之后，杆44到达松开位置，从而使得孔眼48脱离杆44。作业者随后拉动控制区段52，使止动绳从金属格架上脱开，并穿过与承载夹具的网孔邻接的两个网孔。
因此，由于夹具止动装置已经独立于修补物，所以其可以沿着内腔路径抽出。
应当理解，由于在修补物的驱动下而弹性保持在闭合位置的夹具的存在，使得这种修补物有效地保持压靠在血管的内表面上。另外，由于夹具在修补物放置就位的同时闭合，因此可以相对容易地安装这种修补物。
图6显示了本发明的修补物的变型实施例。
图6中显示的血管修补物包括本身由八个诸如线材F1，F2，F3的弹性金属线材制成的格架100，所述金属线材以下文详细描述的方式扭绞在一起。沿着格架的长度，这些线材限定出多个连续的区域，其在图6中向下依次为：
具有八个环104的端部区域102；
连续的多个区域106，每个区域具有扭绞结108的周向环；
具有端部扭绞部112的端部区域111。
关于线材F1：
所述环104由扭绞至少半圈以形成环的线材F1构成；以及
每个结108由将线材F1与邻接的线材例如F2或F3一起扭绞一圈或更多圈而构成。
因此，在以参考标记115表示的每个双扭绞结的任一侧，所述线材扭绞偶数个半圈，并且特别是两个半圈，形成结的每个线束沿彼此平行并靠近的两个方向延伸。
与之对照，在所谓的三重扭绞结117中，线材扭绞奇数个半圈，特别是三个半圈，每个线材沿着两个方向离开，所述两个方向之间形成远小于180度的角度，例如直角或甚至为如图所示的锐角，从而构成格架的网孔之一的两个邻边。
如图6所示，在所示例子中，线材F1从扭绞部112开始，随后连续形成结115、结117、结115、另一个结115、结117、结115、另一个结115、环213、结115、另一个结115、结117、结115、另一个结115、结117、结115和另一个扭绞部112。
在该实施例中，由参考标记116表示的每个夹具由单根金属线材120形成，所述金属线材的中部接合并缠绕在限定出格架的线材的周围，并且其两个自由端向外弯曲，以形成钩子118。
更确切地说，线材120从结115围绕两个分叉的以一定角度分开的线束扭绞。线材120的每个分支随后与紧随的扭绞结扭绞并且由此沿网孔直径横向延伸，所述两个支臂通过彼此平行并向着各自的弯曲端部延伸而相交。
因此，如在前述实施例中所述，承载夹具的网孔的变形导致夹具打开或闭合，具有弯曲端部的两个支臂彼此相对移动。
在图7的实施例中，钩子218由简单、大体直线状的杆形成，每个杆的一端固定到网孔的端部，并且另一端从格架的大体圆柱形的外表面略微向外伸出。
在该实施例中，当网孔打开时，两个钩子218的突出的端部交叠。然而，当设置在承载夹具的网孔的两侧的两个邻接网孔闭合时，钩子随后彼此分开。
为了将该修补物放置就位，需要具有两个用于保持每个夹具的网孔闭合的装置。最初，它们作用在两个相邻网孔上，以便使夹具能够保持打开。在修补物已经恰当定位之后，松开两个相邻网孔，从而导致夹具闭合并且两个钩子刺入血管壁。

Claims (10)

1.一种可径向变形的管状修补物(10)，其包括能够在小直径的收缩状态和大直径的扩张状态之间变形的格架(12)，该修补物的特征在于，其包括至少两个外部钩子(18；118；218)，该至少两个外部钩子(18；118；218)在它们之间限定出用于钩住外部组织的夹具(16)，所述至少两个外部钩子(18；118；218)由该格架(12)承载并且能够在其中该夹具(16)打开的分开位置和其中该夹具(16)闭合的合拢位置之间移动，每个钩子(18；118；218)从连接端与该格架(12)相连，并且所述夹具(16)的钩子(18；118；218)在该修补物变形期间能够彼此相对移动。
2.如权利要求1所述的修补物，其特征在于，该格架(12)包括形成呈可变形四边形形式的网孔的交叉线材，并且每个钩子(18；118；218)在该四边形的角处与该格架相连。
3.如权利要求1或2所述的修补物，其特征在于，每个钩子(18；218)在其连接端处焊接到该格架(12)上。
4.如权利要求3所述的修补物，其特征在于，每个钩子(18；218)在其连接端处钎焊到该格架(12)上。
5.如权利要求1或2所述的修补物，其特征在于，每个钩子(118)在其连接端处通过围绕该格架(12)扭绞的线束(120)延伸。
6.如权利要求1或2所述的修补物，其特征在于，所述夹具的每个钩子(18)在其钩端呈牧羊杖(24)的形状，所述至少两个外部钩子(18)至少部分地交叠，以便形成所述夹具(16)。
7.如权利要求1或2所述的修补物，其特征在于，每个钩子(218)呈大致直线叶片的形式，当该夹具打开时，所述至少两个外部钩子(218)彼此面对地延伸并彼此分开。
8.如权利要求1或2所述的修补物，其特征在于，该格架(12)能够向着其扩张位置弹性变形。
9.一种用于处理血管的成套工具，该成套工具的特征在于，其包括：
如权利要求1或8所述的修补物；
用于在该夹具或每个夹具的区域中将该格架保持在收缩状态的装置(30)；以及
格架输送管(32)，其限定出用于将该修补物限制在其收缩状态的限制管道。
10.如权利要求9所述的成套工具，其特征在于，所述输送管(32)的限制管道包括用于容纳该钩子(18)的纵向通道(33)。
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FR2865926A1 (fr) 2005-08-12
EP1713414A1 (fr) 2006-10-25
US8361137B2 (en) 2013-01-29
FR2865926B1 (fr) 2006-05-12
WO2005079705A1 (fr) 2005-09-01
EP1713414B1 (fr) 2010-03-31
US20070043432A1 (en) 2007-02-22
CN1917831A (zh) 2007-02-21
DE602005020252D1 (en) 2010-05-12
JP2007521901A (ja) 2007-08-09
JP4476296B2 (ja) 2010-06-09

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