CN101325928A - 用于支架分叉血管的导管系统 - Google Patents

用于支架分叉血管的导管系统 Download PDF

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CN101325928A
CN101325928A CNA2006800462038A CN200680046203A CN101325928A CN 101325928 A CN101325928 A CN 101325928A CN A2006800462038 A CNA2006800462038 A CN A2006800462038A CN 200680046203 A CN200680046203 A CN 200680046203A CN 101325928 A CN101325928 A CN 101325928A
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stent
proximal
support
distal
balloon
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皮埃尔·伊莱尔
马奇尔·范德里斯特
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MINVASYS公司
Minvasys SA
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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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    • 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
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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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    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
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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
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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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    • A61F2250/0039—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

一种支架系统，其包括支架输送导管(2)，该支架输送导管具有导管杆，该导管杆上安装有阶梯式球囊(3)。该阶梯式球囊具有近端部分(31)和远端部分(32)，其中近端部分可膨胀至比远端部分大的扩张直径。双部件支架具有安装在阶梯式球囊的近端部分上的近端部件(11)、安装在阶梯式球囊的远端部分上的远端部件(12)以及位于该双部件支架的近端部件和远端部件之间的无连接区域(13)。双部件支架的近端部件和远端部件均构造有支架撑架，该支架撑架像相互交叉的手指一样延伸至无连接区域内，以在分叉血管的脊部区域中提供改进的撑架覆盖范围。无连接区域有效地消除了在分叉血管中放置双部件支架过程中两个部件相互对齐的任何困难。

Description

用于支架分叉血管的导管系统
技术领域
本发明总体上涉及用于进行血管成形术和血管支架术的导管和导管系统。更具体地说，本发明涉及用于在血管的分叉或侧支处支架血管的导管系统。
背景技术
众多专利和专利申请都涉及用于进行血管成形术和分叉血管支架术的导管和导管系统。例如在下列专利和专利申请中描述了用于处理分叉血管的支架导管组件及方法：US 6,579,312、US 6,540,779、US 6,508,836、US 6,428,567、US 6,387,120、US 6,383,213、US 6,361,544、US 6,221,098、US 6,165,195、US 6,013,054、US 4,896,670、US 6,129,738、US 6,544,219、US 5,749,825、US 20020183763A1、WO 9944539A2、WO 9924104、FR2733689。
在国际专利申请WO2005039681和PCT/EP2006/061615中已经描述了用于支撑分叉血管的改进导管系统。
该导管系统包括第一球囊导管、第二球囊导管和连接装置，该连接装置用来使第一球囊导管和第二球囊导管保持并排结构并沿纵向轴线相互对齐。该导管系统还包括第一可操纵导丝和第二可操纵导丝，这些导丝用于在患者的血管内引导第一球囊导管和第二球囊导管。该连接装置使得该导管系统作为整体前进，并有助于防止支架过早或意外地脱离导管。
该导管系统可布置有呈并排结构的可膨胀球囊，以利用类似于“对吻球囊”技术的方法支撑分叉血管。可选的是，该导管系统可布置有呈低轮廓的交错或串列结构的可膨胀球囊，以利用改进的“对吻球囊”技术支架分叉血管。当以交错或串列结构布置时，第二球囊导管可任选地构造有柔韧管状延伸件，该延伸件使导丝腔从可膨胀球囊向远端延伸。
该导管系统可包括一个或多个安装在第一球囊导管和/或第二球囊导管上并具有各种结构的血管支架。
在文献PCT/EP2006/061615中描述了一些具体结构的支架，这些支架具有对于支撑分叉血管来说最佳的撑架结构。在一优选实施方式中，支架通常构造有多个撑架，这些撑架通过呈开放网眼结构的连接件沿支架的长度连接在一起。这些撑架优选构造成围绕支架周向延伸的正弦波状或波浪形的环。每个撑架沿着支架的圆周具有预定数量的波浪形部或网眼。
根据该文献的教导，支架分为远端区域、脊部区域和近端区域，每个区域中的撑架结构对于将要放置该撑架的血管部分来说都是最佳的。在一个特别优选的实施方式中，脊部区域中的撑架比远端区域和近端区域中的撑架具有更多数量的网眼，而近端区域中的撑架也比远端区域中的撑架具有更多数量的网眼。具体来说，该结构使得脊部区域比远端区域和近端区域扩张得更多，并使得近端区域比远端区域扩张得更多。结果，不同区域的不同扩张特性使得支架与分叉血管的典型几何形状紧密相配，其中靠近分叉的血管的直径通常比远离分叉的血管的直径大，且紧靠着分叉脊部的脊部区域的血管的直径比靠近分叉或远离分叉的血管的直径大。支架的该结构还使得可针对每个区域对扩张支架的抗压扁性或压溃强度进行优化，尽管在每个区域中支架的扩张率都不同。
在该文献的图23中示出了3.0mm(扩张直径)支架的实施例。该支架示出为平放的未扩张管状支架，以显示支架在其制造时和卷曲之前的撑架结构。在该实施例中，支架在远端区域中具有六个撑架，每个撑架具有六个网眼，并且除了最远端的撑架由三个连接件连接之外，均由两个连接件连接在一起；在脊部区域中具有三个撑架，每个撑架均具有八个网眼，并且由四个连接件连接在一起；在近端区域具有五个撑架，每个撑架均具有七个网眼，并且除了最近端撑架由三个连接件连接之外均由两个连接件连接在一起。单个连接件连接远端区域与脊部区域，而三个连接件连接近端区域与脊部区域。
在该文献的图25中示出了3.5mm(扩张直径)支架的另一实施例。该支架在远端区域中具有六个撑架，每个撑架具有八个网眼，并且除了最远端的撑架由四个连接件连接之外，均由两个连接件连接在一起；在脊部区域中具有三个撑架，每个撑架都具有十个网眼，并且通过五个连接件连接在一起；而在近端区域中具有五个撑架，每个撑架都具有九个网眼，并且除了最近端撑架由五个连接件连接之外均由三个连接件连接在一起。与图23所示的实施例一样，单个连接件连接远端区域与脊部区域，而三个连接件连接近端区域与脊部区域。
发明内容
尽管在利用国际专利申请WO2005039681和PCT/EP2006/061615所示的支架治疗分叉病变的方法中已有显著的进步，但该领域仍需要提供用来在血管的分叉或侧支处支架血管的改进系统，更具体地说，需要具有能使其适应分叉血管特有几何形状的设计的系统。
在本发明的主要方面中，其旨在一种支架系统，该支架系统包括：
支架输送导管，该支架输送导管具有导管杆，该导管杆上安装有阶梯式球囊(step balloon)，该阶梯式球囊具有近端部分和远端部分，其中该近端部分可膨胀至比该远端部分大的扩张直径；
双部件支架，该双部件支架具有安装在所述阶梯式球囊的所述近端部分上的近端部件、安装在所述阶梯式球囊的所述远端部分上的远端部件、以及位于该双部件支架的所述近端部件和远端部件之间的无连接区域。
根据本发明的支架系统的独创性在于：由于双部件支架的近端部件和远端部件之间的无连接区域，所以可获得在脊部区域中充分柔韧并且允许容易地接近分叉血管侧支的结构。
在本发明的一个优选实施方式中，所述双部件支架的近端部件和远端部件均构造有在所述无连接区域内相互交叉的支架撑架。
在本发明的另一个优选实施方式中，所述阶梯式球囊的所述近端部分具有圆锥形结构。
在本发明的又一个优选实施方式中，所述阶梯式球囊的近端部分具有圆锥形结构，该圆锥形结构的直径从该球囊的近端向该近端部分的远端增加。
根据第二个方面，本发明旨在一种双部件支架，该双部件支架包括近端部件、远端部件和位于该双部件支架的近端部件和远端部件之间的无连接区域，其中该双部件支架的近端部件和远端部件均构造有像相互交叉的手指一样延伸至所述无连接区域中的支架撑架。
附图说明
图1示出了根据本发明的双部件支架，该双部件支架被构造成用于支架分叉血管，且示出的支架安装在支架输送导管上。
图2为表示图1所示的双部件支架的无连接区域的放大详细图。
图3表示图1的处于扩张状态的双部件支架。
图4表示图1的在分叉血管处扩张的双部件支架。
图5表示在用图1的双部件支架进行支架后的分叉血管。
具体实施方式
图1示出了根据本发明的构造成用于支架分叉血管的双部件支架1。
示出的双部件支架1在未扩张状态下安装在支架输送导管2上。
优选的是，支架输送导管2构造有阶梯式球囊3，该阶梯式球囊3具有近端部分31和远端部分32，它们可膨胀至不同的直径。通常，如图3所示，近端部分31将具有比远端部分32更大的扩张直径。然而，应注意近端部分31和远端部分32的大小关系可以颠倒，例如以便用逆行方法而不是标准的顺行方法支架分叉血管。
因为要适应目标血管中分叉的几何形状，所以阶梯式球囊3的近端部分31可以是圆柱形或圆锥形。
图3示出了阶梯式球囊3的一个实施例，该阶梯式球囊3具有圆锥形的近端部分31，该近端部分31的直径从球囊的近端向近端部分31的远端增加，并且靠近球囊的阶梯处直径最大。
根据本发明的球囊导管可以是用于球囊血管成形术或支架输送导管的任何已知结构，包括快速交换导管结构和跨线(over-the-wire)导管结构。
在一个特别优选的实施方式中，该球囊导管被构造成快速交换导管，其中该导管的近端部由皮下管构成，该皮下管可由不锈钢、超弹性镍-钛或钛-钼合金等形成。该近端部的外部优选涂覆有PTFE或其他高度光滑的涂层。诸如鲁尔锁定连接器之类的近端连接器附接在近端部的近端处并与延伸通过该皮下管的球囊膨胀腔连通。该导管包括与近端部相连的柔韧远端部。通常，柔韧远端部具有延伸通过其大部分长度的两个腔，包括从近端导丝端口延伸至导管远端处的远端端口的导丝腔以及从近端部的球囊膨胀腔连接至安装在柔韧远端部的远端附近的可膨胀球囊内部的球囊膨胀腔。
可膨胀球囊3可由多种已知的血管成形球囊材料制成，这些材料包括但不限于PVC、聚乙烯、聚烯烃、聚酰胺、聚酯、PET、PBT及它们的共混物、混合物、共聚物及复合物。
柔韧远端部通常由柔韧聚合物管构成，并可具有同轴结构或多腔结构。
优选的是，在柔韧远端部上安装一个、两个或更多个不透射线的标记，从而在荧光镜成像中指示可膨胀球囊的位置。
可以包括过渡元件，以使近端部和柔韧远端部之间的刚性形成逐渐过渡，并避免在这两个部分之间的结合处出现应力集中。该过渡元件可被构造成锥形或螺旋的缠绕式元件，其可作为皮下管的延伸件或由丝或管制成的单独件形成。
双部件支架1具有近端部件11、远端部件12和位于近端部件11与远端部件12之间的无连接区域13。
该支架可由无缝金属管例如通过激光切割、退火和电解抛光制成。该支架例如可由具有直径约1.60mm、壁厚约0.11mm的公称尺寸的无缝管形成。
在一个特别优选的实施方式中，该支架由生物相容的高强度铬-钴合金(例如合金L605(ASTM F90-01))制成。可选的是，该支架可由其它生物相容的金属或合金制成，该金属或合金包括但不限于316不锈钢、埃尔吉洛伊耐蚀游丝合金(Elgiloy)或Carpenter MP35。
图2为双部件支架1的无连接区域13的放大详细图。
双部件支架1的近端部件11和远端部件12通常通过切割金属管来形成锯齿形或波浪形的支架撑架14而形成。可选的是，支架撑架14可由金属丝形成。在所示实施方式中，示出的网眼为简单的正弦波浪形；但是包括开放网眼和闭合网眼的其它结构的网眼也是可行的。
任选的是，根据PCT/EP2006/061615中描述的原理，双部件支架1的近端部件11和远端部件12可用不同的撑架结构制成，以适于在靠近和远离脊部区域的血管部分中扩张到不同的直径。
在一个优选结构中，支架撑架14类似于PCT/EP2006/061615中描述的支架实施方式，形成为通过一个或多个连接件彼此相连的周向环。
然而，在近端部件11和远端部件12之间的无连接区域13中没有连接件。无连接区域13中没有连接件使得双部件支架1的近端部件11和远端部件12之间的运动自由度更大。这有效地消除了在分叉血管中放置双部件支架1的过程中这两个部件相互对齐的任何困难。
在一个特别优选的实施方式中，支架撑架14的波浪形部从近端部件11的远端和远端部件12的近端像指状部16一样延伸。如图2所示，为了在分叉血管的脊部区域中提供与通常的单部件支架相当或比其更大的撑架覆盖范围，该指状部16彼此相互交叉以在无连接区域13中使近端部件11和远端部件12形成交迭。
具有双部件支架1的支架输送导管2可以作为用于支撑分叉血管的独立导管。可选的是，在类似于PCT/EP2006/061615的图1-5、18和图20-22的用于分叉血管的双导管支架系统中，该支架输送导管2可用作PCT/EP2006/061615中的第一球囊导管，以简单容易地执行对吻球囊技术。与PCT/EP2006/061615的图1-4所示的并排球囊结构(或双导管系统)相比，PCT/EP2006/061615的图5、18和20-22所示的串列球囊结构会提供横截面较小的附加优点。
当作为独立导管使用时，具有阶梯式球囊3和双部件支架1的支架输送导管2允许利用临时支架技术对分叉进行简单支撑。支架输送导管2被引入患者的血管系统并借助导丝行进至待被支架的血管分叉处。操纵阶梯式球囊3使得双部件支架1的无连接区域13定位在刚好靠近侧支血管分出处的分叉脊部区域。任选的是，可以将第二导丝(未示出)引导至该侧支血管内，以利用“固丝(jailed wire)”技术维持通向侧支血管的通路。阶梯式球囊3利用流体膨胀以使双部件支架1扩张。
图4表示在分叉血管中扩张的图1的双部件支架1。
阶梯式球囊3的近端部分31使双部件支架1的近端部件11扩张至与接近分叉的血管的尺寸相适应的较大直径，阶梯式球囊3的远端部分32使双部件支架1的远端部件12扩张至与远离分叉的血管的尺寸相适应的较小直径。
如图4所示，可以优选地轻微过度扩张血管，因为当球囊3收缩时，血管壁和支架1将会有一些弹性恢复。
在收缩并抽出阶梯式球囊3之后，双部件支架1的近端部件11将移位至侧支的口部304以形成通向侧支7的通路。
图5表示用图1的双部件支架1支架后的分叉血管。
根据临时支架技术，该过程将以对吻球囊膨胀和/或通过在侧支血管中展开支架而结束。此时，第三导丝从双部件支架1的近端部件11内经过在双部件支架1的近端部件11远端的无连接区域13跨越至侧支血管腔。扩张支架的边缘被设计成便于导丝跨越。将固丝抽出后，可以用经典的对吻球囊技术完成该过程。
尽管这里针对实施本发明的示例性实施方式和最佳方式对本发明进行了描述，然而本领域的技术人员应该理解，在不脱离本发明的精神和范围的情况下可对本发明进行多种变形、改进以及对各种实施方式、修改和变体进行再次组合。尽管主要关于血管成形术和分叉血管支架术描述了本发明，然而本发明的装置和方法也可用于其它用途。例如，该导管系统可用于支撑身体的其它器官系统的分叉腔。

Claims (5)

1、一种支架系统，该支架系统包括：
支架输送导管，该支架输送导管具有导管杆，该导管杆上安装有阶梯式球囊，该阶梯式球囊具有近端部分和远端部分，其中该近端部分可膨胀至比该远端部分大的扩张直径；
双部件支架，该双部件支架具有安装在所述阶梯式球囊的所述近端部分上的近端部件、安装在所述阶梯式球囊的所述远端部分上的远端部件、以及位于所述双部件支架的所述近端部件和所述远端部件之间的无连接区域。
2、如权利要求1所述的支架系统，其中，所述双部件支架的所述近端部件和所述远端部件均构造有在所述无连接区域内相互交叉的支架撑架。
3、如权利要求1所述的支架系统，其中，所述阶梯式球囊的所述近端部分具有圆锥形结构。
4、如权利要求1所述的支架系统，其中，所述阶梯式球囊的所述近端部分具有圆锥形结构，该圆锥形结构的直径从所述球囊的近端向近端部分的远端增加。
5、一种双部件支架，该双部件支架包括近端部件、远端部件和位于该双部件支架的所述近端部件和所述远端部件之间的无连接区域，其中所述双部件支架的所述近端部件和所述远端部件均构造有像相互交叉的手指一样延伸至所述无连接区域内的支架撑架。
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