CN102223847B - 用于操纵导管轴的装置和方法 - Google Patents

用于操纵导管轴的装置和方法 Download PDF

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CN102223847B
CN102223847B CN2009801464405A CN200980146440A CN102223847B CN 102223847 B CN102223847 B CN 102223847B CN 2009801464405 A CN2009801464405 A CN 2009801464405A CN 200980146440 A CN200980146440 A CN 200980146440A CN 102223847 B CN102223847 B CN 102223847B
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bending section
elongated tubular
tubular shafts
blood vessel
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D·杜德
T·胡列夫
R·迈克纳尔
B·费尔
P·古普塔
R·奥利维拉
T·彭
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Covidien LP
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Abstract

一种用于在血管的内腔中的治疗部位处执行手术的导管。导管包括细长的管状轴，该细长的管状轴具有近端弯曲部、远端弯曲部和铰链元件。轴的远端部分包括窗，所述窗在铰链元件和细长的管状轴的远端之间延伸穿过轴的侧壁。工作元件布置在细长的管状轴的内腔内，并构造成用于穿过窗在治疗部位处执行手术。弯曲部和铰链元件构造成在治疗部位处将窗推靠在血管壁上。

Description

用于操纵导管轴的装置和方法
相关申请的交叉参考
本申请要求享有2008年12月15日提交的临时申请No.61/122,601和2008年10月13日提交的临时申请No.61/104,836的优先权。这些临时申请的整个内容由此通过参考包含于此。
背景技术
粥样斑块切除(Atherectomy)导管用于从血管去除材料以打开血管的内腔并且提高通过血管的血流量。
粥样斑块切除导管通常具有定位在导管的远端处或附近的切除器。某些粥样斑块切除导管设计成仅沿着其远端周边的一部分切除。这种“定向粥样斑块切除”导管必须被操纵成使得切除器定位在待切除的材料附近。这种操纵可以包括将切除器推靠在血管的一侧上，以便可以切除材料，并且这种操纵可以包括转动导管轴的近端区域，从而使导管的远端区域转动，并由此将位于远端的定向切除器定位在待切除的材料附近。
本发明涉及用于操纵和推动粥样斑块切除导管的切除元件以使切除器定位在待切除的材料附近的装置和方法。
发明内容
本发明提供一种操纵器，所述操纵器与粥样斑块切除导管一起使用来转动、平移、或者转动和平移导管。粥样斑块切除导管可以具有切除元件，所述切除元件能够通过窗伸出以切除感兴趣的材料。可以仅用一只手致动该操纵器。
在本发明的另一个方面中，粥样斑块切除导管设有预形成的远端区域。预形成的远端区域推动粥样斑块切除导管切除器以强迫其与血管的内壁接触。当切除元件遇到组织时，通过导管的预形成的远端区域抵抗趋向于使切除元件从组织偏离开的力。
在一个方面中，本发明涉及一种用于在血管的内腔中的治疗部位处执行手术的导管，血管在治疗部位处具有直径D。导管包括细长的管状轴，所述细长的管状轴具有远端和近端以及侧壁，所述侧壁限定内腔，细长的管状轴具有近端弯曲部、远端弯曲部和铰链元件，近端弯曲部限定大于零的第一角，远端弯曲部限定大于第一角的第二角，铰链元件从细长的管状轴的远端向近端侧间隔开并且从远端弯曲部向远端侧间隔开，远端弯曲部定位在近端弯曲部和铰链元件之间，细长的管状轴的远端部分在铰链元件和细长的管状轴的远端之间延伸，并且细长的管状轴的中间部分在铰链元件和近端弯曲部之间延伸，远端部分包括窗，所述窗在铰链元件和细长的管状轴的远端之间延伸穿过侧壁。导管还包括工作元件，所述工作元件布置在细长的管状轴的内腔内，工作元件构造成用于穿过窗在治疗部位处执行手术，第一角和第二角选择成形成细长的管状轴在近端弯曲部和铰链元件之间、大于直径D的最大偏移，以便使窗被推靠在治疗部位处的血管壁上。近端弯曲部和远端弯曲部可以构造成位于第一平面内，并且铰链元件可以构造成仅在第一平面内允许远端部分相对于中间部分弯曲。第一角和第二角可以选择成以在约0.05磅至0.5磅的范围内的力将窗推靠在血管壁上。第一角可以处于约90°至150°的范围内，并且第二角可以处于约100°至180°的范围内。从近端弯曲部到远端弯曲部的长度可以大于从远端弯曲部到铰链元件的长度。远端弯曲部和近端弯曲部之间的长度可以处于约0.5英寸至2.0英寸的范围内，并且远端弯曲部和铰链元件之间的长度可以处于约0.375英寸至0.625英寸的范围内。最大偏移可以处于约3毫米至40毫米的范围内。
在另一个方面中，本发明涉及一种用于在血管的内腔中的治疗部位处执行手术的导管。导管包括细长的管状轴，所述细长的管状轴具有远端和近端以及侧壁，所述侧壁限定内腔，细长的管状轴具有曲线状的远端部分，所述曲线状的远端部分具有连续减小的曲率半径，连续减小的曲率半径在第一平面内从远端部分的近端到细长的管状轴的远端定向，远端部分包括铰链元件，所述铰链元件与细长的管状轴的远端向近端地间隔开，铰链元件将远端部分分成在铰链元件和细长的管状轴的远端之间的远端分段以及在铰链元件和远端部分的近端之间的近端分段，铰链元件构造成仅在第一平面内允许远端分段相对于近端分段弯曲，远端分段包括窗，所述窗在铰链元件和细长的管状轴的远端之间延伸穿过侧壁。导管还包括工作元件，所述工作元件布置在细长的管状轴的内腔内，工作元件构造成用于穿过窗在治疗部位处执行手术，连续减小的曲率半径选择成在使用期间将窗推靠在治疗部位处的血管壁上。曲线状的远端部分可以形成在约90°至720°的范围内的连续的曲线。曲线状的远端部分的最大曲线直径可以处于约3毫米至50毫米的范围内。
在又一个方面中，本发明涉及一种在血管的内腔中的治疗部位处执行手术的方法。该方法包括提供细长的管状轴，所述细长的管状轴具有远端和近端以及侧壁，所述侧壁限定内腔，细长的管状轴具有近端弯曲部、远端弯曲部和铰链元件，近端弯曲部限定大于零的第一角，远端弯曲部限定大于第一角的第二角，近端弯曲部和远端弯曲部沿着第一方向定向，所述铰链元件从所述细长的管状轴的远端向近端侧间隔开并且从所述远端弯曲部向远端侧间隔开，远端弯曲部定位在近端弯曲部和铰链元件之间，细长的管状轴的远端部分在铰链元件和细长的管状轴的远端之间延伸，并且细长的管状轴的中间部分在铰链元件和近端弯曲部之间延伸，远端部分包括窗，所述窗在铰链元件和细长的管状轴的远端之间延伸穿过侧壁。该方法还包括：将细长的管状轴通过血管的内腔前进到治疗部位；将细长的管状轴定向在这样的位置中，即，在所述位置处近端弯曲部和远端弯曲部使细长的管状轴的远端部分在铰链元件处沿着与第一方向相反的第二方向相对于细长的管状轴的中间部分弯曲以在所述治疗部位处的期望的位置中将所述窗推靠在血管壁上；以及在将所述窗推靠在所述血管壁上的同时，借助布置在所述细长的管状轴的内腔内的工作元件在所述治疗部位处穿过所述窗执行手术。铰链元件可以构造成仅沿着第一方向和第二方向允许远端部分相对于中间部分弯曲。
在又一个方面中，本发明涉及一种在血管的内腔中的治疗部位处执行手术的方法，该方法包括提供细长的管状轴，所述细长的管状轴具有远端和近端以及侧壁，所述侧壁限定内腔，细长的管状轴具有曲线状的远端部分，所述曲线状的远端部分具有连续减小的曲率半径，连续减小的曲率半径沿着第一方向从远端部分的近端到细长的管状轴的远端定向，远端部分包括铰链元件，所述铰链元件从细长的管状轴的远端向近端侧间隔开，铰链元件将远端部分分成在铰链元件和细长的管状轴的远端之间的远端分段以及在铰链元件和远端部分的近端之间的近端分段，铰链元件构造成仅沿着第一方向和与第一方向相反的第二方向允许远端分段相对于近端分段弯曲，远端分段包括窗，所述窗在铰链元件和细长的管状轴的远端之间延伸穿过侧壁。该方法还包括：将细长的管状轴通过血管的内腔前进到治疗部位；将细长的管状轴定向在这样的位置中，即，在所述位置处曲线状的远端部分的连续减小的曲率半径使远端分段在铰链元件处沿着第二方向相对于近端分段弯曲以在所述治疗部位处的期望的位置中将所述窗推靠在血管壁上；以及在将所述窗推靠在所述血管壁上的同时借助布置在所述细长的管状轴的内腔内的工作元件在所述治疗部位处穿过所述窗执行手术。
在又一个方面中，本发明涉及一种用于操纵导管的轴的装置，所述导管包括本体部分和轴接合构件，所述本体部分具有内腔，所述内腔的尺寸设定成接收导管的轴，所述轴接合构件具有封闭在本体部分内的第一轴接合面和第二轴接合面，轴接合构件具有锁定位置和解锁位置，在所述锁定位置中第一轴接合面和第二轴接合面构造成接合轴以将本体锁定在轴上，在所述解锁位置中本体自由转动并在细长的管状轴上轴向地平移。轴接合面可以在锁定位置或解锁位置中被偏压。
在又一个方面中，本发明涉及一种用于接近血管壁上的部位的导管。导管包括细长的管状轴，所述细长的管状轴具有远端和近端以及侧壁，所述侧壁限定内腔，细长的管状轴具有第一弯曲部、第二弯曲部和窗，所述第二弯曲部与第一弯曲部向远端地间隔开了预定的距离，所述窗延伸通过侧壁，所述窗定位在所述第二弯曲部的远端侧并且在所述细长的管状构件的远端的近端侧，第一弯曲部限定大于零的第一角，第二弯曲部限定大于第一角的第二角，第一角和第二角以及预定的距离选择成在使用期间将窗推靠在血管壁上的部位上。细长的管状轴还可以包括铰链元件，所述铰链元件从窗向近端侧间隔开并且从第二弯曲部向远端侧间隔开。另外，导管可以包括工作元件，所述工作元件布置在细长的管状轴的内腔内，工作元件构造成用于穿过窗在血管壁上的部位处执行手术。细长的管状轴可以包括在铰链元件和细长的管状轴的远端之间的远端部分，并且铰链元件可以构造为远端部分围绕其弯曲的枢转点。另外，远端部分可以具有纵向轴线，并且铰链元件可以构造成使得当在使用期间将窗推靠在血管壁上的部位上时，远端部分定位成使得远端部分的纵向轴线基本上与血管的纵向轴线平行。
在又一个方面中，本发明涉及一种用于在血管的内腔中的治疗部位处执行手术的导管，所述导管包括细长的管状轴，所述细长的管状轴具有远端和近端以及侧壁，所述侧壁限定内腔，细长的管状轴具有近端弯曲部、远端弯曲部和铰链元件，近端弯曲部限定大于零的第一角，远端弯曲部限定大于第一角的第二角，所述铰链元件从所述细长的管状轴的远端向近端侧间隔开并且从所述远端弯曲部向远端侧间隔开，远端弯曲部定位在近端弯曲部和铰链元件之间，细长的管状轴的远端部分在铰链元件和细长的管状轴的远端之间延伸，并且细长的管状轴的中间部分在铰链元件和近端弯曲部之间延伸，远端部分包括窗，所述窗在铰链元件和细长的管状轴的远端之间延伸穿过侧壁，近端弯曲部、远端弯曲部和铰链元件构造成在治疗部位处将窗推靠在血管壁上。导管可以包括工作元件，所述工作元件布置在细长的管状轴的内腔内，工作元件构造成用于当在使用期间将窗推靠在血管壁上时穿过窗在治疗部位处执行手术。
本发明的这些和其它方面将从以下优选实施例的说明、附图和权利要求而变得清楚。参照附图和以下说明阐述本发明的一个或多个实施例的细节。本发明的其它特征、目标和优点将从说明和附图以及从权利要求而变得清楚。
附图说明
图1A示出根据本发明的原理的轴操纵器的一个实施例的示意性平面图；
图1B示出图1A中所示的轴操纵器的立体图；
图1C和1D示出沿着图1A中所示的轴操纵器的线A-A得到的剖视图；
图2A示出根据本发明的原理的轴操纵器的另一个实施例的示意性平面图；
图2B示出图2A中所示的轴操纵器的立体图；
图2C和2D示出沿着图2A中所示的轴操纵器的线A-A得到的剖视图；
图3A和3B示出根据本发明的原理的轴操纵器的又一个实施例的示意性平面图；
图4A和4B示出根据本发明的原理的导管的又一个实施例的示意性平面图；
图5A至5C示出根据本发明的原理的导管的又一个实施例的示意性平面图。
具体实施方式
参照图1A至1D的实施例，本发明涉及一种用于操纵导管轴的装置。结合粥样斑块切除导管说明本发明，但是本发明可以与任何其它导管一起使用。
粥样斑块切除导管20具有工作元件22，例如切除元件。切除元件可以通过导管的轴26中的窗24延伸。可以理解，工作元件可以是任何其它元件，例如RF元件、可视化元件或植入输送元件。典型地，导管20可以具有3Fr至7Fr的工作直径并且具有60cm至180cm的工作长度。
可以通过转动轴26操纵工作元件22的定向，以便使手柄28可以在轴转动的同时保持固定。轴会可按增量转动或者可调节到任何角度定向。在某些实施例中，轴联接到手柄，以在对轴施加适度的转矩时允许轴相对于手柄转动。在其它实施例中，轴可转动地固定到手柄，以在对轴施加适度的转矩时不允许轴相对于手柄转动。
轴操纵器10可转动地且可滑动地联接到轴26，并且该轴操纵器构造成用一只手使用。操纵器10包括本体12、按钮14、弹簧16和枢转销18，所述本体具有内腔11。按钮14还包括臂14c，该臂中具有用于使枢转销可滑动地配合通过的孔。本体12和按钮14可以由聚碳酸酯、尼龙或其它材料制成，并且可以被注射模制或以其它方式制造成期望的构造。本体12可以模制成两个半部分，并且在按钮、枢转销和弹簧组装到本体中之后，这两个半部分通过超声波、咬合配合、粘结剂、或其它装置结合在一起。在一个实施例中，通过图1B中的线A-A限定本体12的两个半部分。按钮14的面14a、14b可以是有纹理的，以用于增大抵抗轴26或操作者的手指或二者的摩擦。弹簧16和枢转销18可以包括诸如钢、弹簧钢、或其它金属的金属，或者诸如聚酯、液晶聚合物、尼龙或其它聚合物的工程聚合物。
操纵器10通常处于解锁(图1C)位置中，其中弹簧16伸展以迫使按钮14的面14a远离轴26。操纵器通常被解锁以允许使用者容易将操纵器10移动到沿着轴的任何期望的位置。例如，使用者可以在用一只手保持手柄28的同时用另一只手将操纵器移动到轴的暴露的远端部分，例如在切口附近或在导引器护套附近的轴的一部分。一旦操纵器定位在沿着轴的期望的位置处，则可以通过在使用者用一只手将按钮14的面14b朝向彼此加压并随后用同一只手转动或平移(或二者)操纵器10而实现轴26的转动或平移(或二者)。
现在说明图1A至1D的导管和操纵器的用法。导管20以任何已知的方式引入到患者体内。当使用者期望操纵导管时，使用者抓紧操纵器10并将其移动到用于操纵导管的适当的位置。然后，使用者通过在面14b上施压以克服弹簧16的力并将面14a移动到与轴26摩擦接触，而将操纵器锁定到轴。然后，操纵器被转动、平移、或转动和平移二者以实现与诸如粥样斑块(atheroma)的组织接触的切除器22的转动、平移、或转动和平移二者。在某些实施例中，切除器22沿着径向方向延伸到窗24之外，并且在切除器22延伸以切除粥样斑块的情况下导管20穿过血管前进。在某些实施例中，粥样斑块由切除器22导引到导管的内部。
已经说明了轴操纵器处于常解锁位置中，然而，在其它实施例中，轴操纵器可以处于常锁定位置中，从而使用者将压力施加在卡爪上以打开卡爪而不是关闭卡爪。图2A至2D示出构造成处于常锁定位置中的轴操纵器30。操纵器30可转动地且可滑动地联接到轴26，并且轴操纵器30构造成用一只手使用。操纵器30包括本体32、臂34、弹簧36和枢转销38，所述本体具有内腔31。臂34中具有用于使枢转销可滑动地配合通过的孔，臂34具有面34a并且具有可以被扩大的端部34b。本体32、臂34、面34a、弹簧36和枢转销38可以基本上分别与上述本体12、按钮14、面14a、弹簧16和枢转销18一样由材料制成、制造并且组装。
操纵器30通常处于锁定(图2C)位置中，其中弹簧36伸展以迫使臂34的面34a与轴26摩擦接触。操纵器通常锁定以允许使用者容易转动或平移(或二者)轴26。使用者可以通过将臂34b朝向彼此加压以迫使面34a脱离与轴26的接触(图2D)，并随后在轴26上转动或平移(或二者)操纵器30，而用一只手将操纵器30移动到沿着轴26的任何期望的位置。例如，使用者可以将操纵器移动到轴的暴露的远端部分，例如在切口附近或在导引器护套附近的轴的一部分。使用这种操纵器的优点在于，操纵器可以容易地沿着轴定位并且在用一只手保持手柄28的同时用另一只手操纵。
现在说明图2A至2D的导管和操纵器的用法。导管20以任何已知的方式引入到患者体内。当使用者期望操纵导管时，使用者抓紧操纵器30，并且通过在端部34b上施压以使面34a移动脱离与轴26的摩擦接触，而将操纵器从轴解锁。然后，使用者将操纵器30移动到用于操纵导管的适当的位置。然后，去除端部34b上的压力，从而允许弹簧36将面34a移动成与轴26摩擦接触。然后，操纵器被转动、平移、或转动和平移二者，以实现与诸如粥样斑块的组织接触的切除器22的转动、平移、或转动和平移二者。在某些实施例中，切除器22沿着径向方向延伸到窗24之外，并且在切除器22延伸以切除粥样斑块的情况下导管20穿过血管前进。在某些实施例中，粥样斑块由切除器22导引到导管的内部。
参照图3A和3B的实施例，示出用于与操纵器45一起使用的另一个导管40。导管40可以与上述的导管20类似，但是可以是具有工作元件、具有与上述的轴26类似的轴26或另外的轴的任何其它的导管，并且无论如何都添加有环部42。操纵器45可以包括上述的操纵器10、30，或者可以是另外的操纵器。手柄48可以与上述的手柄28类似，但是可以是任何其它的手柄。
导管40包括轴46，所述轴具有定位在操纵器和手柄之间的环部42。环部42可以由柔性的导管部分形成并且当形成时包括间隙44，该导管部分设计成在操纵轴时形成为环部或者可以是预形成的环形导管部分。轴46固定地联接到手柄48，以便使轴相对于手柄不会转动或平移。当操纵器45转动或平移时，环部42具有充分的柔性以在不需要手柄的方位或位置改变的情况下允许轴的远端部分被操纵器转动或平移。在轴46相对于手柄48转动或平移的过程中，环部42的直径47可以变大或变小，并且间隙44可以增大或减小，以在允许手柄48保持处于不变的位置中的同时适应轴46的转动或平移。
现在说明图3A和3B的导管的用法。导管以任何已知的方式引入到患者体内。当使用者期望操纵导管时，使用者抓紧操纵器并且将操纵器移动到用于操纵导管的适当的位置。然后，使用者将操纵器锁定到轴上。随着轴被操纵，环部将根据需要而压缩、膨胀或改变间隙，以在手柄位置保持不变的同时适应轴的转动、平移、或转动和平移二者。在某些实施例中，切除器22沿着径向方向延伸到窗24之外，并且在切除器22延伸以切除粥样斑块的情况下导管20穿过血管前进。在某些实施例中，粥样斑块由切除器22导引到导管的内部。
图4A和4B示出用于与操纵器55一起使用的另一个导管50。轴的远端部分的形状设定成提供附着力以将切除元件推靠在血管壁上。导管50可以与上述的导管20类似，但是可以是具有工作元件、具有与上述的轴26类似的轴56或另外的轴的任何其它的导管，并且无论如何都添加有转向部(jog)51j和预形成的弯曲部51p、51d。导管50还包括可以在构造、材料和功能方面分别与工作元件22和窗24类似的工作元件52和窗54。窗54定位在轴上的径向内部位置处，以便当导管定位在血管内时工作元件52被推靠在血管壁上。转向部51j和预形成的弯曲部51p、51d协同操作以推动工作元件52与血管中的待切除的材料接触。操纵器55可以包括上述的操纵器10、30或者可以是另外的操纵器。具有导管50的操纵器55的用法是任选的。手柄58可以与上述的手柄28类似，但是可以是任何其它的手柄。
导管轴56包括转向部51j和预形成的弯曲部51p、51d。转向部51j包括铰链结构，所述铰链结构允许轴56的远端部分56d相对于轴56的中间部分56m急剧地弯曲。在2004年7月21日提交的、公布为US 2005/0177068A1的美国专利申请10/896,741的段落[0092]至[0094]、[0100]至[0102]、[0105]至[0107]和附图1、1A、2、4A和4B中进一步说明了能够转向的导管结构。US专利公布US 2005/0177068的整个内容由此通过参考包含于此。在一个实施例中，预形成的弯曲部形成为使得中间部分以及在中间部分的近端处的导管轴的部分位于第一平面内，并且铰链元件构造成仅在第一平面内允许远端部分相对于中间部分弯曲。预形成的弯曲部51p、51d可以通过在将远端部分56d约束在金属模具中之后施加热而形成，以便使导管56具有模具的形状，或者可以通过对于本领域的技术人员已知的其它手段来形成。预形成的弯曲部51p的角53p小于预形成的弯曲部51d的角53d。预形成的弯曲部51p可以具有90度至150度的角。在一个实施例中，预形成的弯曲部51p具有100度至120度的角。在其它实施例中，角53p是95度、105度、110度、115度、125度、130度或140度。预形成的弯曲部51d可以具有100度至180度的角。在一个实施例中，预形成的弯曲部51d具有120度至140度的角。在其它实施例中，角53d是110度、130度、150度、160或170度。从预形成的弯曲部51p到预形成的弯曲部51d的长度通常大于从预形成的弯曲部51d到转向部51j的长度。从预形成的弯曲部51p到预形成的弯曲部51d的长度可以是0.5英寸到2.0英寸。在一个实施例中，从预形成的弯曲部51p到预形成的弯曲部51d的长度是1.00英寸到1.25英寸。在其它实施例中，从预形成的弯曲部51p到预形成的弯曲部51d的长度是0.75英寸、1.5英寸或1.75英寸。从预形成的弯曲部51d到转向部51j的长度可以是0.125英寸到1.0英寸。在一个实施例中，从预形成的弯曲部51d到转向部51j的长度是0.375英寸到0.625英寸。在某些实施例中，从预形成的弯曲部51d到转向部51j的长度是0.25英寸、0.5英寸、0.75英寸或0.875英寸。组合的弯曲部51p、51d和这些弯曲部之间的长度以及弯曲部和转向部之间的长度使导管56从导管56的未弯曲部分至转向部56j具有最大偏移56e。通常，本发明的导管选择成使其偏移大于将使用导管50的血管或管道的直径。偏移56e可以是3毫米至40毫米。在一个实施例中，偏移56e是5毫米至8毫米。在某些实施例中，偏移56e是4毫米、5毫米、6毫米、7毫米、8毫米、10毫米、12毫米、15毫米、20毫米、25毫米、30毫米或35毫米。
当导管50定位在直径D小于未受约束的偏移56e的血管V内时，迫使预形成的弯曲部51p和51d以在转向部51j允许导管50的最远端部分沿着血管V的内壁定向的同时，预形成的弯曲部所呈现的角大于其不偏离的预形成的角。由于预形成的弯曲部企图恢复其不偏离的预形成的角，转向部51j和弯曲部51p、51d之间的协同操作迫使或推动窗54以与血管V的内壁接触。预形成的弯曲部51d维持切除器52和窗54在血管直径的下端部处抵抗血管V的内壁的附着力。随着血管直径增大，预形成的弯曲部51p最终也开始向导管尖端施加附着力。推力可以为0.05磅至0.5磅。在一个实施例中，推力是0.1磅。在某些实施例中，推力是0.075磅、0.2磅、0.3磅或0.4磅。诸如切除器的工作元件52可以通过窗54延伸以接触诸如粥样斑块的待切除的材料。在切除过程中，将通过如上所述产生的推力抵抗趋向于使切除器从血管内表面偏离开的力。轴56的远端部分可以通过操纵器55(如果使用的话)转动、平移、或转动和平移二者以确保窗54沿周向定向成接触待切除的材料。
现在说明图4A和4B的导管的用法。选择具有大于血管V的内径的偏移56e的导管50。任选地，导管以任何已知的方式在导丝上引入到患者体内到达待去除材料的血管V中的位置。导管在导丝上引入时趋向于略微伸直并且跟随导丝到达该位置。与转向部51j协同操作的预形成的弯曲部51p、51d将窗54推靠在血管V的内壁上。在某些实施例中，切除器52沿着径向方向延伸到窗54之外，并且在切除器52延伸以切除粥样斑块的情况下导管50穿过血管前进。在某些实施例中，粥样斑块由切除器52导引到导管的内部。任选地，当使用者期望操纵导管时，使用者抓紧操纵器55并且将操纵器55移动到用于操纵导管的适当的位置。然后，使用者将操纵器锁定到轴56上并且在手柄58的位置保持不变的同时转动、平移、或转动和平移轴。
图5A至5C示出用于与操纵器65一起使用的另一个导管60。轴的远端部分的形状设定成提供附着力以将切除元件推靠在血管壁上。导管60可以与上述的导管20类似，但是可以是具有工作元件、具有与上述的轴26类似的轴66或另外的轴的任何其它的导管，无论如何都添加有转向部61j和连续减小半径的曲线部61。转向部61j在构造、材料和功能方面可以与转向部51j类似。导管60还包括可以在构造、材料和功能方面分别与工作元件22和窗24类似的工作元件62和窗64。工作元件62定位在轴上的径向内部位置处，以便当导管定位在血管内时工作元件62被推靠在血管壁上。转向部61j和连续减小半径的曲线部61协同操作以推动工作元件62与血管中的待切除的材料接触。操纵器65可以包括上述的操纵器10、30或者可以是另外的操纵器。操纵器65与导管60的用法是任选的。手柄68可以与上述的手柄28类似，但是可以是任何其它的手柄。
导管轴66包括转向部61j和连续减小半径的曲线部61。连续减小半径的曲线部61可以通过在将导管轴66的远端部分66d约束在金属模具中之后施加热而形成，以便使远端部分66d具有模具的形状，或者可以通过对于本领域的技术人员已知的其它手段来形成。远端部分66d可以卷曲约至少90度直到至少720度。图5A示出卷曲约360度的轴，并且图5B示出卷曲约720度的轴。在其它实施例中，远端部分66d卷曲约120度、150度、180度、240度、300度、480度或600度。最大曲线直径63可以从3毫米到50毫米变化，虽然依据具体应用最大曲线直径可以在该范围以外。在一个实施例中，最大曲线直径是10毫米至12毫米。在其它实施例中，最大曲线直径是4毫米、6毫米、8毫米、15毫米、20毫米、25毫米、30毫米或40毫米。
在另一个实施例中，连续减小半径的曲线部61可以包括多个离散的预形成的弯曲部(未示出)。可以理解，减小半径的段的数量可以变化。例如，导管可以具有从2个到100个段。在其它实施例中，导管可以具有4个、6个、8个、10个、15个、20个、40个、60个、75个或100个段。在另外的实施例中，导管具有如图5A至5C的连续可变的实施例中所公开的无限数量的段。
连续减小的半径用于在血管直径的范围上提供相对均匀的附着力。当然，由于不同患者的血管几何结构和尺寸会有相当大的变化，所以实际的附着力可以在使用期间相当大地变化；然而，轴的形状趋向于在血管尺寸的范围上提供均匀的力。
当导管60定位在直径D小于最大曲线直径63的血管V内时，在转向部61j允许导管60的最远端部分沿着血管V的内壁定向的同时迫使连续减小半径的曲线部61的直径增大。由于曲线部61企图恢复其未变形的直径，所以转向部56j和曲线部61之间的协同操作会迫使或推动窗64以与血管V的内壁接触。诸如切除器的工作元件62可以通过窗64延伸以接触诸如粥样斑块的待切除的材料。在切除过程中，将通过如上所述产生的推力抵抗趋向于使切除器从血管内表面偏离开的切除力。轴66的远端部分可以通过操纵器65(如果使用的话)转动、平移、或转动和平移二者以确保窗64沿周向定向成接触待切除的材料。
现在说明图5A至5C的导管的用法。导管以任何已知的方式在导丝上引入到患者体内到达待去除材料的位置。导管在导丝上引入时趋向于略微伸直并且跟随导丝到达该位置。与转向部61j协同操作的曲线部61将窗64推靠在血管V的内壁上。在某些实施例中，切除器62沿着径向方向延伸到窗64之外，并且在切除器62延伸以切除粥样斑块的情况下导管60穿过血管前进。在某些实施例中，粥样斑块由切除器62导引到导管的内部。任选地，当使用者期望操纵导管时，使用者抓紧操纵器65并且将操纵器65移动到用于操纵导管的适当的位置。然后，使用者将操纵器锁定到轴66上并且在手柄68的位置保持不变的同时转动、平移、或转动和平移轴。
已经参照优选的实施例说明本发明，但是当然可以在脱离上述的说明性的实施例的情况下实施本发明。

Claims (12)

1.一种用于接近血管壁上的部位的导管，所述导管包括：
细长的管状轴，所述细长的管状轴具有远端和近端以及侧壁，所述侧壁限定内腔，细长的管状轴具有第一弯曲部、第二弯曲部和窗，所述第二弯曲部从所述第一弯曲部向远端侧间隔开预定的距离，所述窗延伸穿过所述侧壁，所述窗定位在所述第二弯曲部的远端侧并且在所述细长的管状轴的远端的近端侧，所述第一弯曲部限定第一预成形角，所述第二弯曲部限定大于所述第一预成形角的第二预成形角，所述细长的管状轴的尺寸设计成使得使用期间在血管中，所述第一弯曲部被偏离以限定大于所述第一预成形角的第一偏离角，并且所述第二弯曲部被偏离以限定大于所述第二预成形角的第二偏离角，所述第一预成形角和第二预成形角以及所述预定的距离选择成在使用期间将所述窗推靠在所述血管壁上的所述部位上。
2.根据权利要求1所述的导管，其中，所述细长的管状轴还包括铰链元件，所述铰链元件从所述窗向近端侧间隔开并且从所述第二弯曲部向远端侧间隔开。
3.根据权利要求1所述的导管，还包括工作元件，所述工作元件布置在所述细长的管状轴的内腔内，所述工作元件构造成用于穿过所述窗在所述血管壁上的所述部位处执行手术。
4.根据权利要求2所述的导管，其中，所述细长的管状轴包括在所述铰链元件和所述细长的管状轴的远端之间的远端部分，并且所述铰链元件构造为所述远端部分围绕其弯曲的枢转点。
5.根据权利要求4所述的导管，其中，所述远端部分具有纵向轴线，并且所述铰链元件构造成使得当在使用期间将所述窗推靠在所述血管壁上的所述部位上时，所述远端部分定位成使得所述远端部分的纵向轴线基本上与所述血管的纵向轴线平行。
6.根据权利要求2所述的导管，其中，所述第一弯曲部和第二弯曲部构造成位于第一平面内，并且所述铰链元件构造成仅在所述第一平面内允许所述细长的管状轴向所述铰链元件的远端侧弯曲。
7.根据权利要求1所述的导管，其中，所述第一预成形角和第二预成形角选择成以在0.05磅至0.5磅的范围内的力将所述窗推靠在所述血管壁上。
8.根据权利要求1所述的导管，其中，所述第一预成形角处于90°至150°的范围内，并且所述第二预成形角处于100°至180°的范围内。
9.根据权利要求2所述的导管，其中，从所述第一弯曲部到所述第二弯曲部的长度大于从所述第二弯曲部到所述铰链元件的长度。
10.根据权利要求1所述的导管，其中，所述第一弯曲部和第二弯曲部之间的长度处于0.5英寸至2.0英寸的范围内。
11.根据权利要求2所述的导管，其中，所述第二弯曲部和所述铰链元件之间的长度处于0.375英寸至0.625英寸的范围内。
12.根据权利要求3所述的导管，其中，所述工作元件是粥样斑块切除装置。
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