CN101188984A - 用于分叉支架的输送系统 - Google Patents

用于分叉支架的输送系统 Download PDF

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CN101188984A
CN101188984A CNA2006800180807A CN200680018080A CN101188984A CN 101188984 A CN101188984 A CN 101188984A CN A2006800180807 A CNA2006800180807 A CN A2006800180807A CN 200680018080 A CN200680018080 A CN 200680018080A CN 101188984 A CN101188984 A CN 101188984A
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delivery system
support
stent delivery
propped
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CN101188984B (zh
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E·康斯坦丁诺
T·费尔德
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Trireme Medical LLC
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Abstract

用于对准和展开侧支支架的系统包括在其远端处或附近具有侧支传感器的导管。方法包括转动和轴向地转移导管直至传感器与侧支脉管的开口对准。

Description

用于分叉支架的输送系统
技术领域
本发明涉及医疗方法和装置，更具体地说，涉及用于治疗脉管系统在分叉损伤处或其附近的狭窄的医疗装置。
背景技术
支架置入术是一种常用的医疗过程，主要针对狭窄脉管的脉管再造(revascularzation)，其中扩张堵塞的动脉并放置支架(stent)以在扩张之后保持脉管的开放。该支架是小型的管状装置，通常是金属网状结构或其它的架子，并可涂覆有药物或含有药物的聚合物。
尽管支架在治疗脉管系统中的各种损伤方面是成功的，但它们的成功局限于对冠状动脉和颈动脉的分叉损伤的治疗。通常，在分叉损伤处的支架网状结构会禁止侧支通路并限制向侧支的血流且同时干涉流动方式。
临床文献描述了在治疗分叉损伤中使用支架所遇到到困难。除了诸如过程时间长之类的突出问题之外，还可能由于过程期间受限的侧支通路以及需要使用在它们的设计和标记之外的传统支架而引起并发症。长期结果较差且再造率相比其它损伤要高。
人们已尝试涉及专用的支架和输送方法以用于在冠状动脉和颈动脉中放置支架并处置分叉损伤。然而，目前的解决方案仍存在各种缺点，如其外形相对传统的支架要高，需要笨重的输送系统来将支架放置到正确的位置以及面对侧支的转动定位准确度不足。通常脉管侧支比主支小且分叉的分岔角各不相同。这些方案还需要口部的侧支支撑以及经由支架覆层对分叉区域进行局部药物输送。
一些现有技术采用两根引导线来输送和定位支架，从而在支架中的侧孔或支架的侧部区域会面对侧支脉管。在Fischell等人的5,749,825、Richter等人的5,755,735、Adams等人的6,099,497、Vardi等人的6,596,020、Vardi等人的6,706,062、以及Von Oepen的6,048,361中可以看到一些例子。
需要两根引导线以及通常需要容纳这些引导线的两个内腔会要求有与传统的支架和输送系统相比外形较高的系统(即直径相对大)，导致输送支架困难且临诊过程更长。在许多情况下，两根引导线的分叉支架输送系统还要求有比传统的支架输送系统更大的引导管。此外，医师转动导管以实现转动定位的能力十分有限，且必须单单通过预先放置的引导线来将该系统引导到所述位置和径向姿态。由于引导线的自然柔性和引导线直径(通常为0.35mm)与侧支直径(通常为2mm或更大)之间的较大差值，支架可能无法准确定位。支架的侧部可能没有面对侧支的中心部分，并且在许多情况下仅支架的侧孔或侧部的一部分面对脉管的侧支。通过使用较刚性的引导线来改进对准可能会导致其它的问题。例如，传统的金属引导线会影响分叉处的局部几何形状并掩盖真实的分叉角度。一旦在过程结束时拉出引导线，侧支角度会恢复其原始的姿态，有时会在支架与动脉壁之间留下间隙，导致临床效果较差。
其它系统设计成展开支架，这种支架利用两个气囊对侧支开口提供至少局部的支撑。在美国专利第4,994,071号(转让给Cordis)和转让给Advanced StentTechnoligies的申请US 2005/0102019和US 2005/0060027中可以找到一些例子。这些系统很复杂且需要对两个独立的气囊进行充气，外形高，且由于支架下方过多的材料叠置使系统的工作端刚度增加而导致可输送性差。
当利用上述系统来治疗分叉损伤时，医师将一根引导线放置在主脉管中并将第二根引导线放置在侧支中。这样可保持至这两根脉管的通路。与这样地使用两根引导线相关的常见问题是两引导线会绕彼此缠绕。这种现象被称作“线交叉”，并且在需要使用两根导管时十分常见。目前的分叉支架输送导管利用两根引导线且无法输送穿过这样的交叉线。在一些情况下，医师需要收回包括引导线的整个系统，从而增加了发病几率和过程的复杂度。医师不得不对动脉重新布线并开始一个新的系统。
出于这些原因，目前可用的用于分叉损伤的输送系统在性能方面以及在准确地轴向定位支架和保证支架的侧部或侧孔面对脉管的侧支的能力方面是有限的。人们希望提供仅需要单根引导线来放置的用于输送分叉支架的导管系统。
发明内容
本发明揭示了一种用于具有侧支部分的分叉支架的输送系统。该系统包括具有单根引导线内腔的导管，该导管在其远端附近具有可扩张的或其它支架展开壳体或其它支架展开区域，该远端用于输送和展开支架且使侧支部分至少部分地展开。
在一个实施例中，该导管轴设计成相应操作者施加的扭矩而转动。
在另一个实施例中，该系统包括传感机构以识别侧支开口。示例性的传感机构包括成像部件和刺入件，所述刺入件在支架朝向侧支适当地定向时侧向展开到侧支中。
在一个实施例中，该系统通过通常是经由电路传送的来自操作者的信号来对准。导管的远端部分设计成响应该电子信号而转动。也可以使用标记物来帮助准确地定位支架。
附图说明
图1是本发明导管的全视图，其中未展开的分叉支架装设在展开气囊上。
图2是图1的支架在展开后的全视图。
图3示出导管的远端，该导管带有传感机构以识别侧支的位置。
图4示出位于图2导管的近端毂上的指示器，该指示器向医师提供何时系统已正确定向的指示。
图5示出该系统相对于3mm参照脉管的尺寸。
图6示出两线系统相对于3mm参照脉管的尺寸。
图7示出具有“弹出”标记物以帮助识别侧支位置的输送系统。
图8A和8B示出带有滑动标记物以帮助识别侧支位置的输送系统。
具体实施方式
本发明提供一种用于分叉支架或其它假体的输送系统，该分叉支架或其它假体具有主体和侧支部分或侧孔。术语“侧支部分”包括在主体中的任何开口或结构，它在主体位于主内腔或脉管中时将与侧支内腔或脉管的口部对准。该侧支部分可以是呈假体结构中的网格结构或狭缝形式的简单的孔，它预先选择为要与侧支脉管对准，但在其它方面类似于假体中的其它网格结构、狭缝或类似物。不过，更通常的是，该侧支部分将是扩大的或可扩大的网格结构，它可与假体的相连或其余结构区分开。在另外的实施例中，“侧支结构”包括自打开或可由气囊打开的周边结构，它用于在假体在主支中打开后跨接侧支口部的周缘。本专利的分叉支架适于放置在所有类型的分叉损伤和靠近脉管中的分叉的损伤处，或者所有类型的口部损伤处，包括主动脉口和吻合处，其中侧部位于假体的一端并通常包括扩口部分。
根据本发明来输送的支架或其它假体通常具有大体管状的结构，包括能通过气囊充气来扩张以支撑主脉管的主体以及设计成至少部分地扩张入侧支脉管并支撑侧支口部的侧部结构。如果需要，可以使用附加的气囊来完成支架的侧支部分或主体的展开。在共同待审批的第11/330,382(022246-000240US)号中提供了合适的侧支支架的和假体的例子，该文献所揭示的内容已以参见方式预先结合于此。
在图1和2中示出了放置在输送导管上的这种支架的例子。图1示出气囊导管10，该气囊导管具有用于接纳引导线70和独立的气囊充气装置的至少一个内腔。分叉支架30皱缩在气囊20之上，且侧支部分40未打开(图1)。侧部40通常与支架主体一体地形成，但在一些情况下也可以利用激光焊接或任何其它附连工艺来加到支架主体上。导管轴12具有足够的扭转刚度，以响应操作者施加在其近端16(图4)的扭矩而转动。这种扭矩响应例如可以通过利用编织轴、加强轴、海波管或者通过利用合适的芯线或者通过在工业中所用的其它传统方法来实现，以改善该轴的至少一部分的扭矩响应。气囊20通常是用于展开支架和脉管假体的类型的传统气囊(尼龙混合物、pebax混合物或类似物)。侧支部分40初始时是关闭的。为了改善扭矩响应并避免可能由于轴中的扭矩累积而产生的远端不受控制的运动(“抖动”)，可以在轴结构中加入缓冲段，该缓冲段呈非编织段的形式并具有与编织段不同的机械特性。
图2示出在气囊20扩张之后的支架30以及侧支部分40。导管轴12具有终止于远端口32的单个引导线内腔14。传统的气囊标记物60可以用来帮助操作者识别系统在脉管中的位置，并且可以使用诸如超声波变换器、激光二极管、半导体二极管或其它传感器之类的传感机构50来帮助定向系统和确定侧支的位置。
在一个实施例中，传感机构50包括成像部件，该成像部件包括至少一根光导纤维(或其它常用的激光传输元件)，它位于侧支部分40处或附近，典型的是位于导管轴12的远端的周缘上，且在自扩张支架或其它假体的情况下较佳的是在气囊20附近或在气囊20上。可通过光导纤维系统发出光线或其它可检测的辐射并由光导纤维系统检测反射来帮助定位侧支。可以监测从脉管壁的不同部分反射回来的激光辐射，以识别脉管结构中的变化从而定位侧支开口。特别是，该系统可用于检测反射或计算由于在内腔壁的不同区域中的吸收而造成的能量损失。一根纤维可既用作发送器又用作检测器，或者可使用不同的纤维，这些不同的纤维或者用作纤维束或者分布在导轨的远端区域的周缘上。
在另一实施例中，传感机构可以位于用于输送该系统的引导线70上。或者，传感机构可以位于轴12的中心引导线内腔14中的与引导线互换的另一细长构件上。在所有情况下，传感器可以在导管的远端内移动以帮助识别侧支，并可以向后移动并在指示出侧支位置之后在任何时候选择地撤出。
一旦利用标记物60确定了导管的轴向位置，传感机构就可朝导管的远端移动。然后，操作者可以利用从传感机构接收到的反馈或其它指示靠转动导管，以在展开支架之前帮助支架中的侧孔转动地对准侧支口部。
图3示出利用位于导管轴上支架30和气囊20下方的传感机构80来识别侧支的方式。操作者转动导管轴12并接收来自传感机构80的反馈。如图3所示，传感机构80包括诸如成像传感器之类的传感器，该成像传感器具有穿过侧支40的视野82以帮助指示侧支口部O的位置。在其它的实施例中，传感器可以是能检测侧支附近区域的电化学传感器。如果传感器位于气囊附近，则它可以检测是否存在组织。传感机构可以位于导管10的远端处或其附近，也可以位于气囊20内或气囊外侧。
在另一实施例中，导管的工作端安装在单独的带有小型机械驱动装置的可转动轴上，所述驱动装置诸如为迷你电动机、伺服机构或其它远程操作的驱动机构。操作者可以通过远程地转动导管的该单独的轴来定向导管的工作端，以利用上述反馈机构的任何感知反馈来实现正确的定位。或者，操作者可以完全或部分地通过利用可向导管的远端区域发送信号的操纵杆或其它手动接口装置来控制远端部分的运动。
在再一实施例中，传感机构联接到自动定向系统电路。在本实施例中，系统具有控制器(通常适用数字处理器)以监视从传感机构发送的转动位置信号。该信号用于确定是否工作端已准确地定向。如果没有正确定位，则自动定向系统将转动工作端直至实现正确的定向。在本实施例中，该系统利用传感机构与可控制的电动机或其它定位器之间的反馈回路来自对准以恰当地定位支架。操作者可以输送另一引导线或装置来稳定远端的位置和定向。例如，操作者可以将引导线或光导纤维输送到侧支，来帮助稳定该系统或者在一些情况下固定住该系统。
图4示出具有操作者接口的近端导管毂16，它设有红灯84和绿灯86(或等效的视觉或听觉信号)，以告知操作者是否支架已到达展开位置(绿灯)或不应展开(红灯)。在本例中，用于传感器的电源可以集成在导管中，且整个系统可以是单次使用的系统。
在一个实施例中，操作者接口和相关的电路系统是与导管分开的并可以多次使用。接口可以通过无线连接或实体连接器来联接至传感器或侧支定位器。电源可以是集成的(例如电池)或者是外部电源。
图5示出关于分叉区域附近的3mm脉管的系统剖面。图6示出相对同一脉管的两根引导线的系统的典型剖面。在这些图中示出了单根引导线的系统的优点。由于不再需要如图6所示的第二引导线86(以及用于第二气囊的进入盒体)，本发明的单根引导线的系统的外形可以比两根引导线的系统低20％，通常低30％，典型的是低50％。例如，单根引导线(图5)情况下支架在气囊上的宽度在向远端至任何穿过侧支部分的刺入件的出口点的部分上通常不大于1.5mm，较佳的是不大于1.4mm，以及经常是1.2mm或更小。在较佳的实施例中，在设计用于冠状脉管时该系统的外形约1mm。对于神经脉管的应用场合，该系统可以小得多，但对于颈动脉的应用场合，该系统的外形可能会更大一些。
对于冠状分叉，该装置通常用于直径一般从2.5mm至5mm(没有变狭窄)的脉管。本发明的包括皱缩冠状分叉支架的单根引导线的系统可以小于1.5mm，有时可小于1.4mm，且典型的是接近1.3mm。在一些情况下，分叉支架和输送系统的外形可以接近1.2mm，且有时更低，这取决于支架的尺寸和所要求的特定的解剖学部位。为了比较，输送系统上的传统的非分叉支架的外形通常是1.2mm，典型的是接近1mm，有时是0.9mm或更小。
作为进一步的比较，常用的冠状引导线的直径约为0.35mm。典型的引导线内腔的ID(内径)为0.43mm而OD(外径)为0.58mm。当加上折叠的气囊的尺寸和皱缩的支架的壁厚度(通常大约0.41mm)时，单单用于带有双引导线内腔的双引导线装置的材料叠就大于1.4mm。两根引导线的系统的实际外形典型的是大于1.5mm，通常大于1.6mm，且经常大到1.8mm或更大。在需要第二气囊对侧部进行充气的情况下，则系统的尺寸将在上述的高范围中，且有时会更大。
图7示出单根引导线的分叉支架输送系统100，该系统采用单个气囊102来展开具有侧支部分105的分叉支架104。利用突出的弹性(“弹出”)标记物60来获得该输送系统的定位和定向，该标记物60可被预装载并在侧支分叉处SB附近被释放。在荧光镜成像下可以看见该标记物。当弹出标记物106面对脉管壁时，它保持受到限制。当导管轴108转动(箭头109)时，弹出标记物与侧支SB的开口(os)对准并进入侧支。在侧支SB中的标记物106在荧光镜成像下的外观指示操作者定向接近最优并可以展开支架104。
在一个实施例中，突出的标记物具有柔软的末梢以使脉管创伤最小。突出的标记物可以用诸如镍钛之类的具有极好的弹性或形状记忆的合金制成，或者诸如不锈钢合金、钴铬合金、MP35等的弹性金属以及其它金属制成。突出的标记物或者可以用诸如尼龙或尼龙混合物、pebax之类的聚合物或者任何其它的弹性、生物兼容的聚合物制成。可以将不透射线的材料附连至标记物，以使操作者可以看见它。不透射线的材料可以皱缩、陷型挤压或共同挤压、粘合或以任何本领域所知的其它传统方式放置在弹出标记物系统上。如果在其处于形状记忆状态时使用NiTi，可以通过改变NiTi结构的温度，藉此激活在处理过程施加在标记物系统上的所存储的形状，从而激活突出的标记物。
图8A和8B示出用于带有侧支部分202的分叉支架200的单根引导线和单个气囊的输送系统。在本实施例中，可动标记物204可以穿过在导管的轴208上的内腔206、部分内腔、狭缝或者一个或多个钩或短内腔中滑入和滑出。可动标记物组件204包括细长构件，该细长构件较佳的是用金属线或带、或者诸如尼龙之类的挤压聚合物、或者具有允许在其通道中拉动和/或推动标记物组件的所要求物理特性的任何其它材料制成。细长构件的远端210可以用诸如钛铱或钨之类的标记物材料、或者MRI可见的材料、或者其它目前在本领域所用的已知标记物材料制成。或者，标记物材料可以附连或放置或粘合或连接到标记物组件的端部上。标记物组件可以预先弯成有弯曲部分，从而当在导管的远端处或附近将退出其内腔206时，它就会突出，并且如果当在侧支SB附近时推动，它就会出现在侧支中并可由过程中所用的诸如超声、MRI或CT之类的成像系统来视觉识别。标记物组件204的远端设计成在推抵在脉管壁上时使脉管创伤最小。这样的设计可包括柔软的末梢、聚合物的延伸部、局部打环或其它可选方式。转动轴208包括编织轴段211，该编织轴段211设有引导线内腔212、可动标记物内腔206以及充气内腔214。内腔的直径可以较小并必需与标记物组件的尺寸相符。如果使用镍钛或钢带作为组件，则材料的厚度通常为0.025mm至0.25mm，有时是0.25mm至2.54mm。内腔可以设计成允许标记物干涉配合，或者标记物可以较大。
尽管上面是对本发明较佳实施例的完整描述，但可以采用各种替代形式、改型和等效的形式。因此，上面的描述不应被认为限制本发明的范围，本发明的范围由所附权利要求书来限定。

Claims (18)

1.一种支架输送系统，该系统设有至少一个标记物，该标记物能够在指向血管中的侧支时改变其位置或构型。
2.如权利要求1所述的支架输送系统，其特征在于，操作者至少能够部分地控制所述标记物的所述位置。
3.如权利要求1所述的支架输送系统，其特征在于，所述标记物在一旦定位在血管中的侧支处或附近时就突伸入所述侧支。
4.如权利要求1所述的支架输送系统，其特征在于，设有轴，该轴设计成响应扭矩而转动。
5.一种支架输送系统，该系统包括：
导管轴，该导管轴在其远端附近具有支架展开区域；
支架，该支架在所述轴的所述支架展开区域上具有侧部；以及
在所述导管轴上的侧支传感器。
6.如权利要求5所述的支架输送系统，其特征在于，所述传感器包括成像部件。
7.如权利要求6所述的支架输送系统，其特征在于，所述成像部件设置在所述轴上以通过所述支架的所述侧支部分径向向外地进行观察。
8.如权利要求5所述的支架输送系统，其特征在于，所述传感器包括不透射线的刺入件，该刺入件适于在所述支架朝向侧支定向时侧向展开到所述侧支中。
9.如权利要求7所述的支架输送系统，其特征在于，所述刺入件能穿过所述支架的所述侧支部分展开。
10.如权利要求5所述的支架输送系统，其特征在于，所述支架展开区域包括装载所述支架的气囊。
11.如权利要求5述的支架输送系统，其特征在于，所述导管轴仅具有一个引导线内腔，该引导线内腔延伸穿过装载所述支架的所述气囊。
12.如权利要求11所述的支架输送系统，其特征在于，在所述气囊上的所述支架的宽度不超过1.5mm。
13.一种用于在主内腔的侧支脉管中展开具有侧支部分的假体的方法，所述方法包括：
提供装载具有所述侧部的所述假体的导管；
使所述导管在所述主内腔中前进直至所述侧部位于所述侧支附近；
在观察所述侧部与所述侧支脉管的相对位置的同时，转动和/或轴向定位所述导管；
在观察到所述侧支部分与所述侧支脉管的对准之后展开所述假体。
14.如权利要求13所述的方法，其特征在于，观察包括用所述导管上的成像变换器来对所述主脉管进行成像，以定位所述侧支脉管的开口。
15.如权利要求14所述的方法，其特征在于，成像包括超声波成像。
16.如权利要求15所述的方法，其特征在于，用与所述假体的所述侧部对齐的变换器来进行超声波成像。
17.如权利要求13所述的方法，其特征在于，观察包括用与所述侧支对准的不透射线的探测器来探测所述主支壁。
18.如权利要求17所述的方法，其特征在于，所述探测器是弹性件，该弹性件在转动和/或轴向定位所述导管而被带到所述侧支脉管时，突伸入所述侧支脉管。
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CN102770094B (zh) * 2009-07-02 2015-11-25 特莱特恩医药公司 用于治疗脉管分叉的小孔支撑物
CN105208977A (zh) * 2013-03-13 2015-12-30 波士顿科学国际有限公司 用于完全被覆盖支架的防止迁移组织锚固系统
CN105208977B (zh) * 2013-03-13 2020-06-09 波士顿科学国际有限公司 用于完全被覆盖支架的防止迁移组织锚固系统
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CN109620468A (zh) * 2014-04-04 2019-04-16 W.L.戈尔及同仁股份有限公司 用于分叉的支架移植物的递送和部署系统
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CN105726175A (zh) * 2016-04-28 2016-07-06 南京医科大学第一附属医院 一种用于分叉病变介入治疗的特型主支球囊支架系统
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