CN101703424B - 用于远程操纵外科手术或诊断工具的活动连接装置 - Google Patents

用于远程操纵外科手术或诊断工具的活动连接装置 Download PDF

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CN101703424B
CN101703424B CN2009102217106A CN200910221710A CN101703424B CN 101703424 B CN101703424 B CN 101703424B CN 2009102217106 A CN2009102217106 A CN 2009102217106A CN 200910221710 A CN200910221710 A CN 200910221710A CN 101703424 B CN101703424 B CN 101703424B
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D·J·达尼茨
A·戈尔德
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Novare Surgical Systems Inc
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Abstract

本发明涉及用于远程操纵外科手术或诊断工具的活动连接装置。该活动连接装置用于例如远程操纵在身体的区域内或到达身体的区域的各种外科手术设备和诊断工具。在该装置的近端的区段的运动导致在该装置远端的区段的相应的相对运动。该远端和近端区段通过一组绳索这样连接，即每个近端区段与一个远端区段形成一离散对。这种构造允许每个区段对彼此独立地运动，还允许该活动连接装置进行复杂运动并且采用复杂构造。

Description

用于远程操纵外科手术或诊断工具的活动连接装置
本申请是申请日为2004年5月21日、申请号为200480020940.1、发明名称为“用于远程操纵外科手术或诊断工具的活动连接装置”的申请的分案申请。
技术领域
本发明涉及活动连接装置(机构)及其应用，包括远程引导和操纵外科手术或诊断器械/工具。
背景技术
外科方法，如内窥镜检查法和腹腔镜检查法，通常采用从人体外的位置在目标器官或组织内或者朝向目标器官或组织操纵的器械。内窥镜检查法的例子包括乙状结肠镜检查法、结肠镜检查法、食管胃十二指肠镜检查法和支气管镜检查法。传统地，通过向前推动而使内窥镜的插入管前进，并且通过向回拉该插入管而将其收回。可通过扭转和一般的上/下和左/右运动来引导该插入管的端部。经常地，这种有限范围的运动使得很难(例如，在直肠乙状结肠的结肠部(rectosigmoid colon)中)达到锐角，造成病人不舒服并增大损伤周围组织的风险。
腹腔镜检查涉及根据解剖标志定位套针端口。端口的数量通常随获得满意的组织活动以及暴露手术区域所需预期方法和器械的数量而改变。尽管腹腔镜外科手术有很多好处，如手术后痛苦少，(术后)活动早以及粘连产生减少，但是通常很难实现器官的最佳收缩和传统器械通过腹腔镜端口的可操作性。在某些情况下，这些不足可导致手术时间增加或者元件如手术夹和缝合线的不精确定位。
诊断和治疗应用的易操纵导管也是熟知的。同内窥镜类似，这样的导管包括在通常有限的运动范围内被引导而通行于病人的脉管系统的端部。
已经做了很多努力设计改进易操纵性的内窥镜和导管。例如，Sato的US3,557,780、Ailinger等人的US5,271,381、Alotta等人的US5,916,146和Sakai的US6,270,453说明了具有可通过操纵单组金属丝而弯曲的一个或多个柔性部位的内窥镜器械。通过转动小齿轮(Sato)、操纵旋钮(Ailinger等人)、易操纵的臂(Alotta等人)、或通过滑轮装置(Sato)而从该内窥镜器械的近端来致动所述金属丝。
Boury等人的US5,916,147公开了一种具有四根金属丝的易操纵导管，这些金属丝在导管壁内延伸。每根金属丝在导管的不同部分终止。这些金属丝的近端从导管中松弛地伸出，以便医师可以拉动它们。通过选择性地将这些金属丝设置到张紧状态，医师能够使导管定形(整形)并由此操纵该导管。
尽管上述每个装置都是可远程操纵的，但是它们的运动范围通常是有限的，至少部分通常是因为在易操纵元件的连接链节或区段中仅采用单一绳索组。这样，在每个链节或区段处不可能进行独立运动。相反，远端链节或区段作为一个单元或多个单元弯曲在一起。该操纵装置可能使用起来也很费力，例如在Boury等人的导管中必须分别拉动每根金属丝以使导管定形。此外，例如在采用旋钮和滑轮装置的内窥镜和易操纵导管的情况下，需要经过大量的培训以熟练地操纵该装置通过病人的组织。
因此，具有改进的远程操纵性而可控制地通行于复杂组织的装置，可更加有效并准确地使外科手术及诊断器械和工具行进和展开，并且在各种外科手术方法中，有助于降低对周围组织的损伤，使病人的不舒适感最小化，减少手术时间，甚至可能降低病人的发病率。对这种装置而言，提供更加直观和容易的用户界面以获得这种改进的可操纵性也是有利的。
发明内容
本发明提供一种用于各种目的的活动连接装置，这些目的包括但不限于远程操纵器械如外科手术或诊断的器械或工具，这些器械或工具包括但不限于内窥镜、导管、多普勒流量计、传声器、探测器、牵引器、解剖器、缝合器/吻合器、夹子、抓紧器、剪刀或截切机、切除或烧灼元件等。该活动连接装置可以用于在身体区域内或病人体内的目标位置中操纵这些工具，能够进一步用来致动这些器械和工具或有助于致动这些器械和工具。
在一种变型中，该活动连接装置包括多对链节，每对链节中的每个链节相对于该对链节中的另一个链节保持间隔开一定距离的关系，以及多组绳索，每组绳索使一离散对的链节彼此连接并且在各离散对的链节处终止，使得一对链节中的一个链节的运动导致该对链节中的另一个链节的相应的相对运动。在该活动连接装置远端的相对运动与在近端处的运动相应。
在另一种变型中，该活动连接装置包括连续柔性部件。该连续柔性部件包括多对区段，每对区段的每个区段相对于该对区段中的另一个区段保持间隔开一定距离的关系，和多组绳索，每组绳索使一离散对的区段彼此连接并且在各离散对的区段处终止，使得一对区段中的一个区段的运动导致该对区段的另一个区段的相应的相对运动。在某些情况下，该连续柔性部件可以是如具有多个管腔的导管，其中，每个绳索组在沿着该导管的长度在不同的轴向位置处终止。在其它情况下，该连续柔性部件可以具有螺旋结构，且每个区段对应于螺旋结构的一个回转。如有需要，可以在该螺旋区段或链节之间设置柔性连接件。
该活动连接装置的变型也可以包括可能具有用于接纳一锁定杆的通道的区段或链节，该锁定杆可将活动连接装置的近端固定并保持在一固定位置。代替锁定杆，可在该装置的近端上安装一锁定套以将该近端固定并保持在一固定位置。
外科手术或诊断工具可以连接到根据本发明的活动连接装置的远端或从该远端伸出，或者反过来也可以将该活动连接装置结合进这样的工具。外科手术或诊断工具的例子包括但不限于：内窥镜、导管、多普勒流量计、传声器、探测器、牵引器、解剖器、缝合器/吻合器、夹子、抓紧器、剪刀或截切机、切除或烧灼元件。
附图说明
图1A-1E示出根据本发明一种变型的具有多对由相应的绳索(缆线)组连接的链节的活动连接装置的透视图，图1A示出该活动连接装置处于自然构形，图1B-1E示出该活动连接装置处于不同操纵状态；
图1F是类似于图1A的活动连接装置在端部操纵成具有多个弯曲时远端的透视图；
图2A-2E示出用于根据本发明另一种变型的活动连接装置中的链节的端面图、侧视图和透视图；
图3A-3C是类似于图2A-2E中的链节并具有不同形状的杆部和相应的凹槽的链节的横截面视图，在图3A和3B中，该杆部的远端为凸状，在图3C中为球形，图3A中的凹槽为锥形，图3B为凹面形，图3C为球形；
图3D是根据本发明另一种变型的在链节之间设有球形元件的活动连接装置中使用的链节的横截面视图，图3E是类似于图3D中的链节和球形元件的横截面视图，该链节和球形元件还包括延伸通过并且连通该链节和球形元件的中心通道(通孔)；
图4A-4C是用于根据本发明一种变型的活动连接装置中的链节的横截面视图，示出了绳索连接到链节上的不同模式；
图5A和5B示出用于本发明另一种变型的活动连接装置中的单个链节，图5A是该链节的透视图，图5B是该链节的端面视图，所示的链节包括用于接纳和通过绳索和其它元件的管腔和通道；
图6A-6C示出根据本发明变型的结合有外科手术夹的活动连接装置的透视图；
图7是根据本发明一种变型的结合有导管的活动连接装置的透视图；
图8是根据本发明另一种变型的结合有内窥镜的活动连接装置的透视图；
图9A和9B是用于形成远程牵引器的活动连接装置的透视图，在图9A中，该牵引器为“U”形，在图9B中，该牵引器具有三角形牵引表面；
图9C是根据本发明另一种变型的活动连接装置的透视图，其中该装置连接到使用者的手上；
图10A-10B示出根据本发明另一种变型的活动连接装置的透视图，该装置具有连续的柔性元件，该部件包括螺旋区段，多对这种区段通过相应的绳索组连接起来，图10B是图10A中所示的螺旋区段局部剖开的放大图；
图11是根据本发明另一种变型的活动连接装置的透视图，该装置具有带有多个贯穿的管腔的连续的柔性元件，并且多对区段通过相应的绳索组连接起来；
图12A-12B是根据本发明再一种变型的活动连接装置的远端的透视图，该装置连接有组织切除元件；以及
图13A-13F示出根据图12的活动连接装置的远端，该装置用于远程操纵以烧蚀心脏疾病。
具体实施方式
根据本发明的活动连接装置通常包括多对链节或区段和多组绳索。该活动连接装置可以由单个间隔开的区段制成，即链节，或由连续的柔性部件形成的区段制成。此处所用的术语“链节”和“区段”是指在装置的一端的离散部分或限定区域，该离散部分或限定区域与在该装置的相对端的另一个离散部分或限定区域相对应。无论如何，该活动连接装置都包括多个构成离散对的组成部分的链节或区段。该链节或区段形成一个近端和一个远端，每对中的一个链节或区段位于近端，另外一个链节或区段位于远端。如下面进一步描述的，由连续柔性部件形成的链节或区段例如可以为连续的管状形式，或者例如设置成螺旋状排列，其中，每个区段对应于螺旋结构的一个回转。
每个绳索组将离散对的链节或区段连接到另一链节或区段，以便一对中的一个链节或区段的运动导致该对中的另外的链节或区段的运动。操纵单个链节的能力允许该装置易于形成如在此处进一步详细说明的复杂的三维构造和几何形状。对于依赖于绳索或金属丝的传统的活动连接装置，很难形成这种复杂的几何形状，原因是这种装置是操纵绳索或金属丝通过每个区段并且在最远端的区段终止的普通设计。由此，为对金属丝或绳索组通常为曲线或弓形形式的运动作出协调反应，所有的区段都弯曲在一起。例如，Alotta等人在US5,916,146中描述的该装置具有这种构造。
为举例说明，本发明的活动连接装置将在用于远程引导、操纵和/或致动在身体的较远可接近区域中的外科手术或诊断工具和器械的上下文中进行描述。此处术语“器械”和“工具”可以通用并且指通常由使用者操作以完成特定目的的装置。此处所用的术语“区域”是指处于疾病或非疾病状态的任何实心器官(如肝脏、肾、脑、心脏)或中空器官(如食道、肠、胃、膀胱)、任何实心或内腔(如血管或管)组织，或任何体腔(如瘘管、胸膜或腹膜空间)。除了外科手术或诊断应用，该活动连接装置的其它应用也是可以预期的，并且对本领域的技术人员是显而易见的。这些应用包括但不限于，工业用途，如将工具、探测器、传感器等引航进入到狭窄的空间，或用于精确地远程操纵工具。其它用途包括也希望远程操纵复杂几何形状的领域。这些用途包括娱乐或娱乐表演用途，如玩具或游戏，例如远程操纵木偶、玩偶、小雕像等。
参照图1A所示的变型，活动连接装置100包括多个构成近端106和远端108的链节102。链节A1和A2，B1和B2，D1和D2分别是一个离散对的组成部分，一对中的一个链节位于近端106而另一个链节位于远端108。链节C1和C2为间隔链节，以下将作更详细的描述。近端链节(A1，B1，D1)通过绳索104连接到远端链节(A2，B2，D2)。在近端106和远端108之间设置间隔元件112，以便将近端链节和远端链节分开并使它们保持分割开的关系。该间隔元件112可以为适于目标应用的任何长度，并且通常为中空结构，以便可以容纳连接链节对的所有绳索104以及同该活动连接装置一起使用的希望的工具或器械相关的附加绳索、金属丝、光学纤维或其它类似元件。
根据不同目的，链节可以具有任何尺寸和形状，但是链节的形式通常取决于这样的因素，如病人的年龄、受益区的构造、目标应用和外科医生的喜好。例如，链节102通常为圆柱形，并且包括用于连接链节对的绳索、与同该装置结合使用的希望工具或器械相关的附加绳索、金属丝、光学纤维或其它类似元件通过的通道。该通道的直径通常略大于绳索直径，形成滑动配合。此外，该链节还可以包括一个或多个用于接纳可连接的外科手术器械或诊断工具的元件或用于使致动它们的绳索通过的通道。该链节可通常具有约0.5mm至约15mm的直径，或根据应用更大的直径。对于内窥镜应用，小内窥镜器械的典型直径为约2mm至约3mm，中等尺寸的内窥镜器械的直径为约5mm至约7mm，大内窥镜器械为约10mm至约15mm。对于导管应用，直径可从约1mm至约5mm。通常根据链节之间所希望的弯曲半径的不同，链节的总长将不同。
图2A-2E所示的变型中，链节200通常为圆柱形并且还包括杆部202。链节200可以排列成使杆部202的远端206与形成在相邻区段的表面210中的相应凹槽208接合。杆部的远端可以为各种形状。例如，链节200a和200b分别具有凸起端部206a和206b(图3A，3B)，而链节200c具有球形端部206c(图3C)。同样地，只要允许各链节相互接合并且不会限制活动连接装置运动所需的范围，相应的凹槽就可以为各种对应形状，例如，凹槽206b和206c为凹面的(图3B和3C)或凹槽206a为锥形的(图3A)。
杆部202可通常具有在约0.5mm至大于约15mm之间的长度和在约0.5mm至约2.5mm之间的直径。对于内窥镜应用，杆部直径为约1mm至约1.5mm。如图2A-2E所示，链节200还包括多个用于使连接链节对的绳索通过的通道212。如图5所示，链节500设计成具有一连接通道502，该连接通道502与该区段的外部相通并且朝向该区段的外围设置，用于在该活动连接装置的远端安装其它元件，如能量来源(用来切除或凝结)或光学纤维，或柔性内窥镜。一个以上的链节或区段可以包括一连接通道，以便该连接通道可以从该装置的远端延伸到近端。如果需要，绳索、金属丝、光学纤维、柔性内窥镜等也可以穿过一中心通道504。
链节或区段可以由任何生物适合的材料制成，该材料包括但不限于：不锈钢、钛、钽以及任何它们的合金；聚合物如聚乙烯或其共聚物、聚对苯二甲酸乙二醇酯或其共聚物、尼龙、硅树脂、聚亚安酯、含氟聚合物、聚氯乙烯以及它们的化合物。
如果需要，可以在链节或区段上设置光滑的涂层以有助于该活动连接装置前进。该光滑的涂层可以包括亲水聚合物如聚乙烯吡咯烷酮，含氟聚合物如四氟乙烯或者硅树脂。
在一个或多个区段上也可以包括不透射线的标志以在射线成像时指示该活动连接装置的位置。通常，该标志由荧光透视法检查。
活动连接装置近端的每个链节或区段通过两个或更多绳索连接到其在远端的相应链节或区段上。每个绳索组可由至少两个绳索组成。如注意到的，一对链节或区段的运动由相应的绳索操纵，并且独立于任何其它对链节或区段。例如，在某种变型中，一个绳索组将包括三根以120度分开的绳索。通过采用由三根绳索组成的绳索组来连接每个链节或区段对，可以独立于任何其它链节或区段对而在三个自由度上操纵或运动每个链节或区段对。通过结合多个链节或区段对，实现多个自由度使活动连接装置变成各种复杂的外形。例如，图1F所示的变型中总共有九个链节对，每对均由三根绳索组成的绳索组独立连接，可以在27个自由度上运动。在仅采用单独绳索组来操纵链节的典型传统活动连接装置中无法获得这样多的自由度。
绳索的直径根据应用而变化，其范围可从约0.15mm至约3mm。对于导管应用，有代表性的直径范围可从约0.15mm至约0.75mm。对于内窥镜应用，有代表性的直径范围可从约0.5mm至约3mm。
例如，可以根据绳索材料的种类和编织法或者物理或化学处理改变绳索的柔韧性。通常，根据该活动连接装置的目标应用的需要改变绳索的硬度或柔韧性。该绳索可以是单股或多股金属丝，该金属丝的材料包括但不限于生物适合的材料，如镍钛合金、不锈钢或任何它的合金、超弹性合金、碳化纤维、聚合物例如聚氯乙烯、聚氧乙烯、聚对苯二甲酸乙二醇酯和其它聚酯、聚烯烃、聚丙烯以及它们的共聚物、尼龙、丝绸和它们的化合物，或本领域熟知的其它适用的材料。
参照图1A，固定到近端链节上的绳索通过间隔元件112与该对中的相应远端链节连接。如图1B-1E所示，近端链节的运动会导致远端链节反向的相应(相反，reciprocal)运动。在其它变型中，绳索穿过间隔元件112时可以扭转或转动180度，以便反映出在远端108的相应运动。本发明的活动连接装置可以构造成包括扭转成0到360度范围内任意角度的绳索，以提供360度范围的相应运动。
绳索可以根据本领域中已知的方式固定到一对链节上，如采用粘合剂或采用硬钎焊、软钎焊、焊接等。图4a示出绳索401以这样的方式固定在链节410的通道402内。在图4B所示的另一种变型中，在绳索端部404上例如通过压接、硬钎焊、焊接或粘结安装有绳索终结器400以防止绳索通过通道402滑脱。在进一步变型中，如图4C所示，该绳索终结器400型锻而形成通道402内的斜面，从而在绳索端部404和绳索终结器400之间形成摩擦配合。
图10A和10B示出本发明的一种变型。活动连接装置130的区段不是单个链节或区段，而是由图示为拉长的线圈的连续柔性部件形成。该线圈的每一个回转是该活动连接装置的一螺旋状区段131。区段131具有使通道105平行于线圈的轴而穿过它们的厚度。在近端107处的螺旋区段同远端109处的区段形成离散区段对。每个区段对由其自有的一组绳索111连接。在近端107和远端109之间也设置有间隔元件113，以便将远端区段与近端区段隔开。如前所述，该绳索可以固定到螺旋区段上。
如图11所示，在本发明的又一变型中，活动连接装置132由一连续的导管115形成，导管115具有多个通过整个导管长度的管腔117。连续导管115还可以有选择地包括中央管腔119。绳索组可以穿过导管的长度并且在近端和远端利用如环氧树脂锚固在不同的相应轴向位置，或在区段对的每个区段之间穿过并且在近端或远端锚固在每个区段或每个区段附近。例如，在该装置的近端121，一个绳索组可以锚固在A1，另一个锚固在B1，还有一个锚固在C1。然后，每个绳索组将在该装置的远端123处锚固在相应的位置上，如A2、B2和C2处。
穿过区段对的绳索可被精确地切割成一定长度，但如果需要，可被切割成大约那个长度。一种设置绳索的方法包括利用推进器使绳索通过管腔向前移动。在推进器上的可视标志或可触知止动件可以指示将推进器推进多远。移除推进器后，可以向每个管腔中引入一根注射针以在每根绳索的端部使环氧树脂从例如注射器外部沉积到导管中。在另一种方法中，例如可利用穿过导管整个长度的绳索而应用该方法，可引导注射针在每个希望的绳索连接点处或其附近穿透导管壁而在所希望的点向绳索输送环氧树脂，由此将每根绳索连接到每个相应的区段对上。
尽管前面附图所示的多数活动连接装置仅具有8个链节(4对)，但这仅是为了指示单个装置组件彼此关系的示例性目的。可以采用任意数量的链节或链节对，这取决于这样的因素，即使用者的目标身体区域和活动连接装置的希望长度。例如，图1F的活动连接装置101具有9个链节对。
该活动连接装置中还可以包括间隔链节，即没有被分散组的绳索连接的链节(如图1A-1E中的C1和C2)。这些链节可以在远端或近端中的任一个或两个上插入活动链节之间，用作不能独立致动的被动链节，但是允许绳索组通过而到达相邻活动链节。间隔链节可以用来给近端或远端提供额外长度。此外，该活动连接装置一端包括间隔链节允许成比例地调节相应另一端的运动或动作。例如，在远端包括间隔链节将要求使用者在近端作更大的运动以在远端获得所希望的运动。这在希望完美精确的操纵运动情形中可能是有利的，例如，在缺乏成比例地调节远端运动或动作的情况下，存在使用者可能不具备完成希望程序所需要的机敏的风险的情形。可选地，可以在近端设置间隔链节，在这种情况下，远端运动的程度可以成比例地大于近端运动的程度，这也可能是特别应用中所需要的。
如注意到的，本发明的活动连接装置可以以其本来的直线构形或从病人体外部位在近端进行各种操纵后，用于在身体区域内或朝向病人身体区域内的目标位置引导外科手术或诊断器械/工具。经过适当的插入后，该活动连接装置的近端的运动会导致远端相应的运动。此外，所得到的远端的定向运动可以是反向的、镜像的或其它方向的，这取决于近端相对于远端的转动程度。同样地，近端提供了一个用户界面以控制对远端的操纵和操作，这种用户界面相对于其它依赖于例如滑轮或旋钮来控制操纵金属丝的传统操纵装置更方便和易于使用。例如，这种用户界面允许使用者根据外部定位的近端用户界面，很容易地想象出活动连接装置的位于例如病人内部的远端的形状和定向运动。
如上所述，由于通过离散的绳索组形成多对区段或链节，所以可以实现复杂的运动，包括上、下、左、右、斜向和转动运动。例如，在图1B所示的变型中，当在近端A1致动最远端的链节时，可以致动在远端的最远端链节A2，但所有其它链节保持静止。为示例起见，示出最远端链节转动形成一直立圆锥114a，该直立圆锥的底部直径随着这样的因素增大，即杆部长度的增加、绳索柔韧性的增强和除其它链节外增加间隔链节103(如C1)。
如图1C所示，当仅在近端致动最近端链节D1时，在远端的最近端链节D2被致动，但所有其它链节都保持静止。由于增大了被致动的区段的数量(由此增大了倾斜高度)，所以经过转动直立圆锥114b的底部直径大于图1B中的圆锥114a的底部直径。
如果致动在近端的中间链节如图1D中的B1，在所有其它链节保持为直线或彼此静止时，只有远端相应的中间链节B2被操纵并可被转动形成如具有弯曲侧面116a的圆锥。或者，如图1E所示，通过操纵最远端的链节A1可以形成具有弯曲侧面116b的更大的圆锥，从而所有近端链节都弯曲成曲线。在远端的所有链节随后将以相反方式模仿该曲线。
尽管在图1B-1E中示出了转动运动，但是此外也可以实现包括上、下、右、左和倾斜运动的其它复杂的三维运动。例如，图1F示出沿其长度具有多个弯曲(122，124，126)的活动连接装置的远端120，每个弯曲在彼此独立的方向上取向。如注意到的，图1F的活动连接装置101具有带三个绳索组的九对链节，每个链节提供27个自由度上的运动，但是链节对和绳索组的其它构形将容易地实现类似的复杂运动和几何外形。通过独立地致动由其相应的绳索组控制的各链节或区段对，使活动连接装置具备这样的能力，即不同部分可同时沿不同方向弯曲并且能形成活动的复杂构形。
当区段通过绳索组连接时，区段的自然构形通常是线性的。这样，如果希望在活动连接装置的远端保持某种弯曲或其它复杂构形，可在近端区段内滑动的有韧性的导管可以成形为使近端区段并由此它们相应的远端区段保持在特定构形。例如，在外科医生例如致动与该装置相关的工具或同时进行一单独程序的同时，操纵该装置到达希望的目标位置并且希望将该装置“锁定”就位的情况下，这可能是有利的。术语“有韧性”是指导管足够柔韧而能够具有某种形状，但又足够硬而保持这种成形的形状。在另一种变型中，一锁定杆可以插入一个或多个贯穿链节或区段的连接通道而将该活动连接装置的近端和远端区段“锁定”就位。该锁定杆可以是有韧性的金属棒，该金属杆可以被定形并随后插到连接通道中以将近端和远端区段设定成特定构形，或者以预先定形的形式提供该锁定杆。
其它固定或锁定该活动连接装置就位的方法包括通常使用的利用球-承窝类型的接头和张紧的绳索一起来构形的链节。这种系统的例子通常描述在如Corey，Jr.et al的美国专利No.5,899,425中。在这种系统中，穿过接头的绳索被张紧，使球和承窝摩擦地锁定在一起。该绳索可以通过多种方式张紧，包括如通过将张紧绳索的末端固定到一拧入螺母的螺杆上，而该螺母固定在该装置的近端。图3D和3E举例说明了用于本发明的活动连接装置中的球-承窝类型的链节系统。如图3D所示，每个链节300都具有用于接纳设置在链节之间的球形元件或球302的凹窝301。当沿链节的轴线线性地施加拉紧力时，由于球和承窝之间的摩擦力链节将锁入位。图3E示出类似构形的链节系统，每个链节310和球312都具有用于使张紧的绳索通过的对齐的通道313和314。
该活动连接装置可以用于远程操纵外科手术器械、诊断工具、各种导管等进入中空或有腔室的器官和/或组织，这些器官和/或组织包括但不限于：血管(包括头颅内的血管、大血管、周边血管、冠状动脉、动脉瘤)、心脏、食道、胃、肠、膀胱、输尿管、输卵管、排泄管如胆管，以及大小气管。该活动连接装置还可以用于远程引导外科手术器械、诊断工具、各种导管等作用于实心器官或组织，这些器官或组织包括但不限于：皮肤、肌肉、脂肪、脑、肝脏、肾、脾以及良性或恶性肿瘤。该活动连接装置可以用于包括人的受治疗哺乳动物，(哺乳动物包括但不限于灵长类动物、畜牧业动物、运动型动物、猫、狗、兔、田鼠和老鼠)。
该活动连接装置通常可以用于在近端有用户界面而在远端有致动元件的任何应用领域或者结合入具有这种特征的其它装置中。该用户界面可以包括活动连接装置的近端，而其远端可以连接到致动元件上。例如，在图6A中示出一个可远程操纵的外科手术夹。钳口602连接到该活动连接装置的远端604上。近端606嵌在钳柄608上。使用者能够通过操纵活动连接装置的近端606而远程定位钳口602。中间部分(“颈”)610也可以设置有外科手术器械，其长度和柔韧性随应用的不同而不同，该颈起到间隔元件的作用。图6C示出另一种变型，其中，外科手术夹630的钳柄632从近端634伸出。在其它变型中，钳口602可以换成剪刀或其它剪切元件、解剖器、组织抓紧器或针抓紧器、缝合装置、烧灼或切除装置，和或其它类似工具或器械。
在另一变型中，该活动连接装置本身可以形成钳口。在图6B中，手术夹612具有用户端部，近端区段614从手术夹的枢轴616伸出。源于近端区段614的绳索分成两根绳索，每根都在枢轴616的区域内，从而在近端的每根绳索可以随后在形成相对的钳口618，618的两个分开的活动连接装置中终止。这样，当使用者操纵近端区段614时，该钳口618将保持对齐并且相应地被远程操纵。如有必要，近端区段614可以伸出并从手术夹的手柄620进行操纵。该钳口可进一步构造成具有特殊的组织结合表面以及切除元件。
在又一种变型中，该活动连接装置可以结合进导管，并且用于如以困难中心线布置或以透皮肤或图像引导排泄管布置来引导该导管。如图7所示，导管700可包括一活动连接装置，该活动连接装置的近端702构造成作为用户界面的一体元件，在该例子中为手柄706。远端区段708形成导管的远端部分，并且可以随着其前进远程操纵引导导管700。在另一种变型中(图中未示出)，该活动连接装置可以象导丝一样旋拧通过导管，以致于使近端区段从导管近端伸出，例如直接从导管管腔伸出，或者从一分开的Y字形连接器中伸出。远端区段可以从导管尖端伸出，并且随着其前进该导管可被远程引导到其目标位置。典型地，随后将移除该活动连接装置以允许该导管流通。但是，如果采用的活动连接装置具有一中心管腔，就可以不必进行该移除。
在同样的模式中，该活动连接装置可以结合入并用于操纵柔性内窥镜。在图8中，设有内窥镜800，从而该活动连接装置的近端806形成了内窥镜手柄804的一体部分。该装置的远端808将构成内窥镜插入管810的全部或一部分。在操纵近端区段806时，就可远程操纵插入管810。
在另一变型中，如图9A和9B所示，该活动连接装置可以用作手持或自保持牵引器(retractor)900。近端区段902和远端区段904可以从牵引器手柄906中伸出。操纵近端区段902将以相应的方式移动远端区段904。可以操纵远端区段以形成多种复杂形状，所希望的形状取决于特殊的应用。在操作中，可首先将远端定位成所希望的形状，然后将其与目标组织相接合。可选地，在操纵远端的同时可进行组织收缩，即远端可以与目标组织接合并且通过对远端的操纵作用可使组织被收缩。
在使用中牵引器通常必须保持其形状。由此，采用如前述方法可以将该牵引器“锁定”就位。例如，该装置可包括具有球和承窝构造与锁定绳索(未示出)的链节。可选地，在操纵近端区段902前可以在其上面设置一有韧性的外壳，或者如前所述可利用锁定杆(未示出)以特殊构形固定牵引器。在图9A中，该牵引器900为“u”形。在图9B中，该牵引器900具有三角形收缩表面。如注意到的，牵引器的形状可以改变，这取决于如所涉及的解剖结构或外科手术方法的类型一样的因素。
在另一种变型中，多个活动连接装置可结合成这样的方式，即使用者的手指运动可被远程模仿。例如，该装置的近端可固定到使用者的手指上，如捆扎在每个手指上，或者固定到使用者可以穿戴的手套上。于是，远端将根据使用者手指的运动而运动。在图9C所示的变型中，装置950包括三个可以通过使用者的拇指、食指和中指的运动操作的活动连接装置。如所看到的，近端951、952和953通过带957分别固定在使用者的拇指、食指和中指上。该装置还通过带958牢固在使用者的手上，带958将间隔元件956的近端固定在使用者的手腕上。使用者的拇指、食指和中指的运动分别导致远端961、962和963的相应运动。这些变型在需要对组织或器官进行粗略地操纵的各种外科手术情形中是有利的。在这种及其它变型中，可在该装置上延伸覆盖一保护性柔韧外壳以避免单个链节或绳索对组织的潜在危害。
在另一种变型中，该活动连接装置可用于心房纤维性颤动的内窥镜治疗。具体地，本发明的活动连接装置可适于在心脏组织中促进烧灼损害的形成，它已经被证实在治疗心房纤维性颤动中是有效的，如下面文献中所描述的，例如Cox，J.L.(2000).″Minimally Invasive Maze-III Procedure，″Operative Techniques in Thoracic and Cardiovascular Surgery Vol.5(1)：79-92；Simha et al.(2001).″The Electrocautery Maze-How I Do It，″TheHeart Surgery Forum Vol.4(4)：340-345；和Prasad et al.(2001).″EpicardialAblation on the Beating Heart；Progress Towards an Off-Pump MazeProcedure，″The Heart Surgery Forum Vol.5(2)：100-104；以及如在Cox等人的美国专利No.6,161,543所描述的。这些程序可包括心外膜或心脏内的切除，和许多需要进入病人心脏的后部但该进入可能很困难的程序。本发明的活动连接装置可以设置切除元件，并且同时具有形成复杂几何形状的能力；该装置可容易地通过心脏的周围结构并易于定位在心脏后部内或心脏后部上的各个位置以利于这种切除治疗。
图12A所示的活动连接装置131包括连接到电磁能量源(未示出)例如在射频(RF)或微波频率范围产生能量的能量源上的切除元件125。这类切除元件在本领域是熟知的，包括通常在US6,471,696中描述的那些切除元件。该切除元件通过连接件134安装到该装置的远端141的链节上，该连接件134与链节142的通道144相匹配的接合。该切除元件包括一绝缘部分127，该绝缘部分通常由热塑性弹性体形成并且具有用于将能量传递到其所在的组织中的纵向延伸的天线或金属丝129。其它的天线或金属丝几何形状，包括螺旋状线圈和印刷电路等，同样是有效的。设有用于以单极构造将能量源连接到天线或金属丝上的绝缘导线136和137。双极构造也可以考虑。该切除元件也设置有附加连接器138和139，它们可起到各种作用，如提供温度或其它传感器或探测器，或者如在Phan的美国专利申请公开US2003/0078644中所描述的，将冷却介质输送到该元件上以冷却周围组织并防止大量的组织损害。
图12B示出构造成用于切除的本发明的活动连接装置的另一种变型。在这种变型中，构造成双极使用的活动连接装置133包括具有远端链节152的远端143，该远端链节152包含反向电极159。这些反向电极由通道164分开。绝缘导线如导线166和167将每对电极连接到能量源上(未示出)。通电时，能量通过电极对传输，在周围组织导致切除。此外，还设有附加连接线168和169以提供附加功能，这些附加功能包括探测器、传感器和冷却流体。
尽管上述变型采用依赖电磁能的切除元件，但是根据本发明的活动连接装置也可以容易地适于结合本领域已知的其它切除方法。例如，该切除元件可以为低温或超声波探测器，或使用激光能量的切除元件，或其它已知的切除技术。
如图13A-13F所示例子中示出的，可以形成心外膜烧灼性损伤。最初，通过活动连接装置131接近病人心脏929后部可以通过如胸廓切开术、微型胸廓切开术或设置在病人前胸壁上的套管针端口(如5-10mm端口)完成。该活动连接装置的间隔元件(未示出)可用作在端口处的转节。当外科医生使病人体外的近端链节弯曲时，病人体内的远端链节会以相应的形式模仿外部链节的弯曲，以在活动连接装置前进的同时环绕上腔静脉933(13A)并继而环绕肺静脉935(13B)。当处于图13B所示的位置时，该活动连接装置远端上的切除元件可以随后被致动而形成损害(lesion)，如此处具体示出的，肺部环绕损害943(图13C)。在图13D和13E中，所示的活动连接装置被重新设置成从肺静脉935向下延伸，以形成下至二尖瓣环的损害939，该二尖瓣环连接到预先形成的肺部环绕损害943(图13F)上。
本发明还涉及用于提供各种活动连接装置和相关附件的成套工具。例如，可以提供包含具有不同长度、不同区段直径、和/或不同类型的外科手术器械、或不同类型的锁定杆或有韧性的外壳的活动连接装置的成套工具。该成套工具可以根据特殊程序如内窥镜检查、收缩、或导管布置和/或用于特殊病人群体如儿科或成年人进行调整。
在此所引用的所有出版物、专利和专利申请被全文引用作为参考，就如每个单独的出版物、专利或专利申请被专门并单独地说明而结合在此作为参考。尽管为了清楚理解本发明，已经通过图示和举例对上述发明进行了详细描述，但是本领域中的普通技术人员在本发明的教导下应当明白，对本发明进行某些改变和修改并未脱离所附权利要求的精神和范围。

Claims (5)

1.一种外科手术器械，该外科手术器械包括：
近端和远端；
联接到位于所述近端附近的用户界面的第一链接部件；
联接到位于所述远端附近的钳口的第二链接部件；
在所述第一链接部件和所述第二链接部件之间延伸的长形的形成颈的轴；
至少一组绳索，该至少一组绳索延伸穿过所述轴并连接到形成一离散对的所述第一链接部件和所述第二链接部件使得所述第一链接部件的运动引起所述第二链接部件的相应运动；以及
活动连接锁定机构，该活动连接锁定机构构造用于选择性地将该外科手术器械在所述远端锁定在一构型中，
其中，所述用户界面包括手柄，该手柄具有连接到所述第一链接部件的第一部分和枢转地连接到该第一部分的第二部分，所述用户界面构造用于通过相对于所述手柄的所述第一部分枢转所述手柄的所述第二部分来操作所述钳口，
其中，所述第一和第二链接部件各包括连续的柔性部件，该柔性部件具有多个柔性区段，相邻柔性区段之间设置有柔性连接件，所述柔性区段还包括多个贯通的管腔，所述绳索可移动地通过所述管腔；
其中，该外科手术器械如此构造使得，通过所述至少一组绳索，所述手柄相对于所述轴的运动引起所述钳口相对于所述轴的成比例的运动。
2.根据权利要求1所述的外科手术器械，其特征在于，所述第一链接部件包括第一组链节，所述第二链接部件包括第二组链节，第一组链节中的每个链节通过不同组绳索连接到第二组链节中的相应的链节。
3.根据权利要求1所述的外科手术器械，其特征在于，所述第一链接部件的运动导致所述第二链接部件的反向的运动。
4.根据权利要求1所述的外科手术器械，其特征在于，所述第一链接部件的运动导致所述第二链接部件在与所述第一链接部件的运动相同的方向上的运动。
5.根据权利要求1所述的外科手术器械，其特征在于，所述活动连接锁定机构包括球和承窝接头，其中在球和承窝之间施加摩擦以将该外科手术器械在所述远端锁定在一构型中。
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