CN104640583B - 阻塞通路系统 - Google Patents

阻塞通路系统 Download PDF

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CN104640583B
CN104640583B CN201380009039.3A CN201380009039A CN104640583B CN 104640583 B CN104640583 B CN 104640583B CN 201380009039 A CN201380009039 A CN 201380009039A CN 104640583 B CN104640583 B CN 104640583B
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handle
tip
departure angle
wire
guide wire
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CN104640583A (zh
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J·(M.D.)·格利
J·C·特劳特曼
B·A·德拉梅纳德伊尔
C·鲍德温
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Merit Medical Systems Inc
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Bluegrass Vascular Technology Co Ltd
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Abstract

一种导管系统，用于在颈部区域中穿过阻塞部位而建立中心静脉系统通路。

Description

阻塞通路系统
发明背景
患者中心静脉系统的通路对于进行许多拯救生命的医疗操作而言是非常必要的。在颈部区域获得静脉系统通路的常用方法是采用置有导丝的大号针头直接穿刺颈部的大静脉。导丝支撑着穿刺位点处介入器件的剩余部分，并通常最后会置入一个导引鞘或其类似物。当大静脉有血块堵塞或纤维性阻塞时就会产生问题。在这样的情况下，常用的护理标准则是通过颈部区域另一个或备选的大静脉来获得静脉通路。大静脉的相继损失非常普遍，但是本发明人认为这是非常不可取的行为。
值得参考的现有技术包括Pillai的公开文本(US2012/0136320)和(US2012/0136247)，二者共同教导了使用软性可弯折双腔导管作为传统直接穿刺技术的备选方案来获得中心静脉通路。Pillai文献并没有给出对已经堵塞的血管进行恢复或挽救的解决方案。例如，在Pillai文献中，使用者将一个双腔管鞘引入腹股沟或手臂的静脉血管系统，然后将可弯折的管鞘或导管导航到颈内静脉。然后，将硬质成型的钢丝置入管腔之一并迫使软性可弯折端呈弯钩形。接着，用锐钢丝针(needle wire)塞入已经卷曲的伴行管腔中，穿破血管后将其拉出体外。Evan(US2004/0181150)通过对比教导了软性可弯折导管的使用。该导管用于进入体内管腔，然后中空或呈开放状的腔形管伸出导管。推动置于管腔内的卷曲管以及伴行导丝一起穿过体内管腔壁，然后沿着弧线而非直线路径将该组件从患者体内一起取出。
申请人认为，这些方法在出现阻塞时都无法使用，因为二者均未教导在出现阻塞的情况下使用这些装置。二者的概念与本发明不同。实际上，申请人的装置可进入阻塞的血管和确切的目标，并将钢丝针可靠第对准并沿预先设定的笔直路线推进至预先设定的所需出口位置，该出口位置用一个不透射线的外用目标标记物在患者的表面进行标记和确定。
发明概述
本发明涉及用于穿过位于锁骨附近颈部的阻塞大血管从而建立患者中心静脉系统通路的导管系统。与传统方法相反，(本发明)从内而外(inside out)地进入所述的中心静脉系统，初始进入点在腹股沟区，而出口位置则在锁骨附近，通常为锁骨之上。
在使用中，在患者的表面放置一不透射线的靶标从而确认并标记所谓钢丝针所需的预先设定的出口点。
通常，利用传统的切入穿刺技术(cut down technique)将延长操作导管(elongate working catheter)通过腹股沟的股静脉导引入静脉系统。通常，将递送管鞘引导套过导丝并引导航至阻塞根部的大致位置，然后在移除导丝后，通过递送管鞘将本发明系统的操作导管段递送到该位置。
应注意，延长操作导管的操作部分自递送管鞘露出，该操作段的刚度足以使其在充分作用力之下被推动、扭转和平移(translate)，从而迫使所述操作段末端的钝性分离尖端进入血管的阻塞部位。
患者外表面不透光的标记物装置或靶标确定了所需的出口定位参考点，利用透视，该标记物能够辅助引导延长导管的操作段进入位点。所述操作段通过平移和转动来进行操控、定向和瞄准，同时通过透视相对于表面靶标的孔隙对其进行观察。在尖端附近的一结构特征能够设定离去角的平面，从而将钢丝针导管置于与患者表面出口点相交的平面。在一实施例中，可从透视可视化设备(C-臂X-射线机)上读取离去角，而可将该离去角输入或设置于随附导管手柄。设定了离去角，就会使钢丝针离去角导引管从适当平面的侧孔穿出，将钢丝针几乎对准离去角度，从而确保钢丝针直接对准目标出口孔。在另一实施例中，导管内的离去角是固定的，给C臂机设定离去角，并将导管的操作段与靶标定位成直线。
一旦经这些结构和方法的瞄准，下一步就是进钢丝针。将所述钢丝针通过离去角导引管送入并穿过阻塞部位、血管壁横断面并对着其取出处的表面靶标形成一个直的组织通道。随着钢丝针通过出口的靶标中央孔取出，优选从体内移除操作段和延长操作导管，并利用钢丝针沿着组织通道放入一个扩张导管从而扩大组织通道。通过在股(静脉)处连续拉钢丝针，可将扩张导管从锁骨附近的伤口出口处拖拽入中心静脉系统并通过阻塞部位，从而便于达到扩张(效果)。在一个实施例中，可将钢丝针锁在手柄上，而去除操作导管能顺行拖拽钢丝针。一旦经过扩张作用而扩大，组织通道就可以常规使用了，沿着其顺行的方向放入一个导引器以获支撑。
附图说明
在几幅附图中，同样的参考数字代表相同的结构，其中：
图1显示了本发明内容的患者示意图；
图2显示了本发明穿入钢丝针的患者示意图；
图3是本发明操作导管的透视图；
图4是本发明操作导管一部分的透视图；
图5是本发明操作导管一部分的透视图；
图6显示了本发明操作导管一部分的示意图，显示了瞄准过程的侧面图；
图7是通过出口靶标看到的本发明操作导管一部分的透视图；
图8是操作段远端区域的另一实施例示意图，其导引管穿出了所述的操作段；
图9是操作段远端区域的可选实施例示意图，其导引管缩回了所述的操作段；
图10是操作导管近端手柄部分的一实施例的横截面。
发明详述
图1显示了患有涉及上腔静脉和右心房水平(近参考数字15)以上颈部区域数个血管的复合阻塞13的患者10。在图中，所述延长操作导管20的操作段18通过钝性分离进入了阻塞部位13。通过向连在延长操作导管20近端的手柄(此图中未示出)施加作用力，从而将所述操作段18的钝性分离尖端22推入所述的阻塞部位。使用者是将所述的钝性分离尖端朝患者头端推进。这个动作会将钝性尖端22置于接近患者表皮的不透射线标记物30附近。该图中还可见，采用传统设计的递送管鞘24以助将延长操作导管20置于阻塞部位的根部26。
图2显示了置于患者10表面的不透射线靶标30，其用于确定患者表面所需的出口点40。正如下详述，钝性尖端22的闭合末端通过透视(前/后位)显影，且尖端22移动至所需的远端位置36。一旦到达所需的远末端位置，观察到C-臂机颅角(cranial angle)，将其用于设定离去角。通常，移动C-臂机从而通过靶标30获取尖端22的图像。钝性尖端的尖角位置取决于钝性分离尖端中的特征狭槽，该特征详见图5。随着钝性尖端围着其长轴旋转，狭槽的透明度会变化，而这变化的图像特征可用于确定离去角导引的出口平面的取向。一旦获得了合适的尖端定位36，就移动C-臂机，并通过靶标30获取尖端22的图像。观察C臂机的颅角，并将其用于设定离去角，该离去角限定组织通道38的角度，使用者通过手柄(本图未示出)向钢丝针32施加作用力，从而将钢丝针32的锐性分离尖端对准不透射线靶标30的中心孔。图中可见，随着钢丝针32的取出，钢丝末端形成的通道能够在出口创口部位用于额外的介入操作，如下所述。
图3单独显示了导管系统12。操作导管的传动轴(shaft)20通过应力消除部(strain relief)14与手柄28相连。导管的远端操作段18以及操作导管的传动轴20可充分地推拉和扭转，从而使钝性分离尖端22能够挤入阻塞部位。经测试，合适的抗弯刚度值约为52(磅作用力)每平方英寸。内径0.74英寸、外径为0.94英寸的不锈钢管可以用于此并符合该参数。然而，可以预见，多种壁厚的结构以及其他弹性材料也可替换使用。例如，可采用嵌入多聚物的编织镍钛或激光切割皮下注射管。必需的功能特征是可经受充分的推拉和扭转，从而通过钝性分离进入阻塞部位。当然，所需作用力的大小也取决于钝性分离尖端22特征的“锋利程度”，以及钝性尖端本身的总直径。通常，尖端的钝性应当满足在操作导管时如果接触皮肤也不会将其刺破。
图4和图5应当一起考虑，其中图4显示了手柄28的细节，而图5显示了尖端的细节。使用时，旋钮(knob)16可以进行翻转或扭转(图4)，从而推进钢丝针的离去角导引管从钝性分离尖端22侧孔21(图5)中穿出。钢丝针离去角导引管34的位置以及离去角可从手柄28上的标尺17上读出。因此，旋钮设定从手柄标尺上读出的离去角。通过手柄28本身的旋转以及对远尖端小孔特征21的不透明度的观察来进行设定离去角导引的平面。
在使用时，手柄28内部的钢丝夹紧和推送系统使得使用者以一种“抽送动作”将钢丝针32送出手柄，如活动箭头27所示。该实施例中，可通过如下方式实现：使滑动头25进行往复运动，从而将钢丝针32沿着由钢丝针离去角导引管的旋转平面和相对于靶标30(图1和图2)的钝性分离远尖端22的位置26所确定的路径通过手柄，进而穿出钢丝针离去角导引管34。
图6和图7应当一起考虑。二者共同显示了利用位于患者表面的不透射线标记物30帮助导管的设定和瞄准。其目标在于通过C-臂机透视方法来快速确定与钢丝针32对准靶标30中央孔31相应的最佳远尖端定位或位置36以及最佳离去角(图中的θ)。适当选择远尖端定位32和离去角θ，钢丝针32所穿过的组织通道38呈一条直线并从所需和预定的位置穿出体外。图6显示了尖端位置36和合适的离去角θ之间的关系。在该图中，解剖结构并未示出以使图更简洁清楚。通常，这两个变量是互补(complimentary)的，且可选择很多数值来保证所述的组织通道38不会与锁骨相切。图7是使用者通过C-臂机透视法所见图像的示意性、简化和高度形式化的图。所述钝性分离尖端22具有一狭槽孔41，其可透过不透射线靶标30的中央孔31看到。所述狭槽41的不透明度会随着运动箭头“R”所示的导管操作段的旋转而改变。通常，当钢丝针导引管平面“瞄准”中央孔31(即，所述导引管的平面与患者出口点相交)时，所述狭槽最亮。当透视机的观测轴(VAF)与靶标对准时(本说明书所假设的情况)，这种情况是正确的。使用者可将尖端22伸出或缩回(“D”)并旋转操作段18(“R”)以优化所设计的组织通道38的位置。一旦选定对准，从C臂上读取对应于θ的角度并将其用于设定导引管位置或离去角。在图4和图10的实施例中，旋动旋钮16直至标尺17与所需的离去角相对应。如手柄上所示，角度范围从约15°到60°不等。这相当于图6所见的垂直于传动轴测量的约75°至30°的操作角度。
图8和图9应当一起考虑。其代表了所述系统的可选实施方式，其中，钢丝针离去角导引管50的数值固定，且不能由使用者进行调节。所述离去角固定的装置与可变角度装置的区别在于牺牲了自由度。即，为了瞄准靶标，引导针相对于尖端的线性行迹只有一个正确的数值。图中只示出了装置的远端部分，而手柄构造的余下细节均是本领域技术人员熟知的，并无需进一步描述。图8中，超弹力离去角导引管50的数值大约为90°。随着钢丝针离去角导引管在管腔52内推进到远部，其从端口54中穿出，并假设其呈现形成组织通道38的构造。该构造的优势在于简洁，但通常只有一个远尖端位置会穿过靶标孔。通过C-臂机透视法，根据某特征(在本实施例中是施加于尖端以便瞄准的高密度不透射线标记物56)的“亮度”再次确定离去角平面的旋转角度。
图10是手柄的剖面，对进行钢丝操作以及离去角设定特征结构进行了的演示示范。该实施方式仅作演示用而非限制。前述的一些部件在此图中未示出，从而简化并阐明手柄的操作。所述手柄大致为具有中心轴的圆柱形。钢丝针离去导引管的一部分可见于34。旋钮16的旋转带动一螺丝，从而使导引管34根据转动的方向伸出或回缩。导引管的定位以及由此的离去角度如其伴行槽内杆60的位置所示。使用者旋转旋钮16，直到指示杆显示从标尺或计量器17读取的缩小离去角度，图4所见最佳。滑动头25与J型臂夹62相互作用，J型臂夹装在枢轴上64从而随着手柄中滑动头伸向远端而向钢丝32楔进。逆行使得J型臂夹放开钢丝，其保持固定，同时滑动头再次向其起始位置移动以便准备另一次钢丝的推进动作。滑动头和手柄结构一起在动作期间支撑钢丝32，使钢丝不会弯曲或打结。该动作是相对固定的，因此使用者可以数出滑动头的动作次数从而估计出钢丝在导引管内伸出多远。
另一种锁定或释放结构66可用于将钢丝与手柄连接，因而取出手柄也会拉出钢丝32或钢丝32完全与手柄脱开，从而使得手柄跨过钢丝退出体外时，而钢丝32仍然留在身体内。

Claims (5)

1.一种使用者用于穿过患者上胸腔部分大血管内的阻塞部位从而建立患者中心静脉系统通路的导管系统，所述的导管系统包括：
施加于所述患者外部，锁骨附近以确定所需出口点的不透射线靶标；
具有近端和远端的延长操作导管；
结合于所述操作导管近端的使用者操纵手柄；
所述操作导管具有接近所述操作导管远端的操作段；
所述操作段的末端为钝性分离尖端，
所述操作导管具有足够的推进和旋转刚度，从而使得所述的钝性分离尖端通过使用者施加于所述手柄上的作用力而进入阻塞部位；
藉此，所述使用者旋转所述手柄使得所述钝性分离尖端旋转并确定转动位置，且所述手柄的平移确定远端位置；
在远尖端内，接近但在所述钝性分离尖端的近侧有离去角导引管，所述离去角导引管具有呈卷曲状的形状记忆部分，并设置成根据所述手柄上的设定从侧端口处穿出，从而提供通过手柄的调节选择出的可变离去角，和从而确定钢丝针的固定离去角并确定钢丝针的出口平面；
藉此，共同观察所述操作段和靶标能够测定出所需的离去角、出口平面以及末端位置，选择两者以便将所述靶标瞄准所述钢丝针；
所述钢丝针包含于并位于所述离去角导引管之内，设置成根据所述离去角导引管进行相对运动，并由所述使用者的操作穿过所述手柄；
所述钢丝针具有一锐分离尖端，
藉此，所述使用者可将所述的锐分离尖端强挤入所述的阻塞部位、血管壁中间组织和皮肤，从而在患者表面的所述靶标位置穿出。
2.如权利要求1所述的导管系统，其特征在于，所述的钝性分离尖端包括：
在X-射线造影下改变的不透射线特征，与尖端旋转的角度呈函数关系，
藉此，使用者可在透视引导下瞄准并定向出口平面。
3.如权利要求2所述的导管系统，其特征在于，所述的不透射线特征是在所述远尖端体内部形成的孔隙。
4.如权利要求1所述的导管系统，还包括：
位于所述手柄上的旋钮，设置为相对于所述手柄旋转，从而所述的旋钮转动拴住螺母；
连接于所述离去角导引管的螺丝形式组件，通过所述拴住螺母进行操控，从而所述旋钮的旋转能控制所述导引管的伸出和回缩。
5.如权利要求4所述的导管系统，还包括：
读出所述离去角导引管相对于所述远尖端的相对定位的标尺。
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