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CN101589964A - 用于挤压骨松质的器械 - Google Patents

用于挤压骨松质的器械 Download PDF

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CN101589964A
CN101589964A CNA2009101490929A CN200910149092A CN101589964A CN 101589964 A CN101589964 A CN 101589964A CN A2009101490929 A CNA2009101490929 A CN A2009101490929A CN 200910149092 A CN200910149092 A CN 200910149092A CN 101589964 A CN101589964 A CN 101589964A
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bone
cannula
distal end
fracture
expandable structure
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克里斯托弗·R·拉尔夫
理查德·W·莱恩
保罗·M·桑德
罗伯特·M·斯克里布纳
马克·A·雷利
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Medtronic Spine LLC
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Kyphon Inc
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    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
    • A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
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Abstract

本发明涉及用于挤压骨松质的器械。包括：外导管体，具有远端；内导管体，具有远端并且延伸通过所述外导管体；以及可扩张结构，具有：近端，连接至所述外导管体的远端上；以及远端，连接至所述内导管体的远端上。本发明的器械能够减少患者的痛苦，降低病灶处发生感染的几率，提高骨折良好愈合的概率，并且使附近关节的退还最少，使之较快地恢复活动。

Description

用于挤压骨松质的器械
本申请是申请日为2001年10月25日、标题为“用骨折复位插管复位骨折的骨的系统和方法”的申请号01818010.8的分案申请。
本申请要求于2000年10月25日归档的美国专利申请60/243,194的优先权。
技术领域
本发明涉及人和其它动物骨髂系统的骨病，尤其是矫正骨病的系统和方法。
技术背景
骨折，尤其是骨质疏松的骨折，常见于老年人。由于骨质疏松骨的特性，标准的骨折固定方法得出不令人满意的结果。这些方法不能够充分地把断骨复位回其骨折前的状态。例如，在非骨质疏松骨折的情况下，通常的方法包括在骨内插入杆、牵引针和/或螺丝以复位骨折和/或把骨折的段固定到夹板上。骨质疏松骨却不支持这种方法。另一种常用于非骨质疏松骨折的方法包括把骨保持在石膏内几周。粉碎性骨折的骨质疏松骨，譬如桡骨远端的科勒斯氏骨折，如果打在石膏中就不会良好地痊愈。骨在力学上受到改变使得短缩和/或消退。又一种非骨质疏松骨折复位方法包括使用外固定装置。然而当用在老年患者时，固定牵引针可能不会保持在脆弱的骨内。而且这样的装置典型地增大治疗位置感染的可能性。再者，因为石膏和/或外固定装置必须留驻数周让骨头愈合，受累区域缺乏关节运动在老年患者固定的关节造成痛苦的关节炎。
即使不存在骨质疏松症，典型地需要固定骨折的骨头让骨正确地愈合。这往往要求固定折骨附近的关节，常常达一大段时间。然而，这种固定往往引起关节随着时间退化。通常，这样的治疗导致暂时性或者永久性关节丧失非运动。无论如何，这样的关节固定要求强化的，并且经常是痛苦的康复让个体全面地恢复其关节运动。
发明内容
因为与治疗诸如科勒斯氏骨折之类的桡骨远端骨折以及其它与之类似的骨折相关的问题，需要提高现有治疗这些骨折的规程的方法和装置，从而减少由使用的骨折固定方法造成的痛苦，降低病灶处发生感染的几率，提高骨折良好愈合的概率，并且使附近关节的退化最少，以及使之较快地恢复活动。本发明提供满足这种需要的骨折复位装置和方法。
本发明提供固定或者复位人和其它动物的骨髂系统的骨质疏松及非骨质疏松骨折的系统。而且，通过立即复位和/加固断骨，从而让骨能够承受的有限的负荷，本发明系统促进断骨的愈合同时使相邻关节的退化最少化。它特别地适用于长骨骨折，譬如人的桡骨远端骨折。
本发明的一个方面提供用于建立经皮进入骨的通道的工具。所述工具是具有形成沿轴线对齐的内膛的侧壁的插管。该插管具有远端。在侧壁中形成周绕的开口。该周绕的开口具有远端。周绕的开口局部地绕侧壁延伸并且沿所述轴线伸长。周绕的开口用于容纳起于所述膛孔的可扩张结构的通道。在一个实施中，所述的膛孔在周绕的开口的远端与插管的远端之间成为实心的。
上述工具的一个变通的实施中，所述膛孔在周绕的开口和远端与插管的远端之间是开放的。插管具有在远端与所述膛孔连通的远端开口。远端的开口可以容纳引导针的通道。
上述工具的一个变通地实施中，插管具有在其远端上的表面，用于把远端锚着在骨内。
本发明的另一个方面提供一种治疗骨病的组件，包括上述的插管。插管具有在远端与膛连通的远端开口。远端的开口可以容纳引导针的通道。所述组件还包括可扩张结构。可扩张结构用于经骨插入插管内并且通过周绕的开口膨胀。
本发明的另一个方面提供一种治疗骨病的组件，包括上述的插管。优选地，所述的膛孔在周绕的开口的远端与插管的远端之间是实的。所述组件还包括可扩张结构。可扩张结构用于经骨插入进插管并且通过周绕的开口膨胀。
本发明的另一个方面提供一种治疗骨病的组件，包括上述的插管。优选地，所述插管具有用于把远端锚着在骨内的在其远端上的表面。所述组件还包括可扩张结构。可扩张结构用于经骨插入进插管并且通过周绕的开口膨胀。
本发明的另一个方面提供一种如上所述的组件，优选所述可扩张结构具有不透放射线的标记。所述的标记让人可以在插管中的周绕的开口内部定位可扩张结构。
本发明的另一个方面提供一种治疗骨病的方法。所述的方法包括提供插管和把插管插入到骨松质内。该方法还包括经插管插入可扩张结构直到该结构与插管中的周绕的开口对齐。该方法还包括经周绕的开口膨胀可扩张结构到与骨松质接触。
本发明的另一个方面提供一种治疗骨病的方法，包括膨胀可扩张结构的步骤。所述的膨胀挤压骨松质。
本发明的另一个方面提供一种治疗骨病的方法，包括挤压骨松质的步骤。挤压骨松质形成空腔。
本发明的另一个方面提供一种治疗骨病的方法，包括把材料输送进入空腔的步骤。
本发明的又一个方面提供一种治疗骨病的方法，包括膨胀可扩张结构使膨胀移动骨折的骨密质的步骤。
附图说明
图1是解剖图，示出前臂骨髂；
图2是解剖图，示出前臂骨髂，包括尺骨和骨折的桡骨；
图3是扩大的桡骨远端的剖面图，示出骨折状态下的骨松质和骨密质；
图4是平面图，示出体现本发明的含有用于治疗骨病的器械的系统的工具盒；
图5是含在图4所示的工具盒中的充填器的透视图；
图6是含在图4所示的工具盒中的经皮插管的透视图；
图7是含在图4所示的工具盒中的钻头器械的透视图；
图8是含在图4所示的工具盒中的骨折复位插管的透视图，示出远端、近端，和周绕的开口；
图8A是根据本发明学说构成的骨折复位插管的变通实施的透视图；
图8B是根据本发明学说构成的骨折复位插管的另一种变通实施的透视图；
图9是图8的骨折复位插管的侧视图，示出通过其中的末端内膛；
图10a是骨折复位插管的远端放大图，该远端是实的；
图10b是骨折复位插管的远端放大图，该远端是开放的，以与引导针的通道连通；
图11是载有可扩张结构的器械的透视图，所述器械含在图4所示的工具盒中；
图12是器械的放大的透视图，示出处于未膨胀状态的可扩张结构并且，以虚线，示出膨胀状态的可扩张结构；
图13是含在图4所示工具盒中的填实器的透视图；
图14是含在图4所示工具盒中的手柄的透视图，示出其中的凹陷；
图15是透视图，示出插入在手柄中的填充器，手柄握在手中；
图15a是侧剖面图，示出插入手柄中并且推进到桡骨远端的填充器器械；
图16是侧剖面图，示出插过填充器器械并且推进到桡骨远端的经皮插管；
图17是侧剖面图，示出在经皮插管内并且推进到桡骨远端的钻头，并且进一步示出远端桡骨骨折和骨松质；
图18是侧剖面图，示出在经皮插管内并且推进到桡骨远端骨松质内骨折复位插管，并且进一步示出面对骨折和周绕开口；
图19是放大图，示出处于骨密质内的骨折复位插管；
图20是放大图，示出处于骨密质内并且含有未膨胀的可扩张结构的骨折复位插管；
图21是放大图，示出处于骨密质内并且含有膨胀了的可扩张结构并且压迫骨松质和/或移动骨密质的骨折复位插管；
图21A是放大图，示出处于骨密质内并且含有膨胀了的可扩张结构、压迫骨松质和/或移动骨密质并且产生跨目标骨内的骨折线延伸的腔的骨折复位插管；
图22是放大图，示出处于骨密质内并且含有膨胀了的可扩张结构的骨折复位插管，示出受压的骨松质、位移了的骨密质，和复位了的骨折，而且还示出经桡骨远端布置进入尺骨的销针；
图22A是放大图，示出处于骨密质内并且含有膨胀了的可扩张结构的骨折复位插管，示出受压的骨松质、位移了的骨密质、复位了的骨折，和跨骨密质内骨折线延伸的腔，而且还示出经桡骨远端布置进入尺骨的销针；
图23是俯视图，示出在毛巾卷上的患者前臂，带有：患者手指上的水平的指套、经手柄插入然后进入经皮插管的器械、被挡住在图上看不到的骨折复位插管，以及插入在患者腕中的牵引针；
图24是放大图，示出由可扩张结构在桡骨远端膨胀产生的腔、在位的牵引针、骨折复位插管，以及准备好接受骨填充材料的腔；
图25是放大图，示出开始填充所述腔的填充材料；
图26是放大图，示出迫使填充材料完全进入所述腔的填实器；
图27是放大图，示出填充了的腔，骨折复位插管和填实器已经撤除了；
图28是放大图，示出带有经之布置的引导针的骨折复位插管。
具体实施方式
本发明可以用几种形式实施而不偏离其精神或基本特点。本发明的范围定义于权利要求书，而不是在此前的说明。所有落入其中或者与权利要求文意等同的实施都由权利要求所涵盖。
优选的实施说明体现本发明骨治疗方面的特征的改进的系统和方法。这是因为在用于此目的时所述新系统和方法是优越的。然而本发明的技术可以有利地应用于身体其它区域内进行诊断或治疗。
下面参照诸如人物桡骨远端的长骨治疗说明所述新型系统和方法。当然可以用相同或者等同的方式治疗人或动物的其它骨型。
I.桡骨解剖
人的前臂由两种骨组成，即桡骨和尺骨。如图1和2中所示，桡骨20是位于前臂姆指侧的长骨，而尺骨26位于小指侧。桡骨20与尺骨26并排，并且不论在长度和大小上都超过尺骨26。
桡骨20的上端或者说近端22较小并且与肘关节的部分，包括尺骨28近端构成关节连接。桡骨20的远端24较大并且与两个腕骨，或者说腕(carpus)的骨，也就是半月状骨21和舟状骨27构成关节连接。桡骨远端24的内侧或者说里侧25含有与尺骨构成关节连接的尺骨切迹32。
II.骨折
本发明的系统和方法特别适用于治疗长骨骨折。一种可以这样治疗的骨折公知于科勒斯氏骨折，也称为桡骨下端骨折。如图2所示，这样的骨折34一般发生在距桡骨20远端24不足一英寸处。科勒斯氏骨折常见于儿童和老年人跌倒时试图用其手或臂抵挡时。儿童的科勒斯氏骨折常与滑板和成行滑冰有关。老年人中，科勒斯氏骨折常由骨质疏松引起和/或与跌倒有关。
骨质疏松是中、老年人，尤其是妇女最常见的骨病。其特征是称为骨密质36的骨组织逐渐丢失。如图3所示，骨密质36，也称为小梁状骨是位于坚硬的外部骨或称骨密质内部的海绵状骨组织。骨松质36包含诸如桡骨20之类长骨末端的多数骨组织。
与骨松质36相比，骨密质38坚硬致密得多。骨密质38包在骨松质36外，并且为诸如桡骨20之类长骨提供保护层和支承，如图1和2所示。然而在这种骨的末端，骨密质38层变薄。当骨质疏松特别地弱化骨松质36时，在长骨末端的这些区域就变得特别易于骨折和/或塌陷。
由于病症或者创伤可能指征复位骨折的骨密质38和/或压迫诸如桡骨20之类长骨内的骨松质36。例如，压迫可以用于形成内腔35，所述的内腔35是用于接受填充材料99，例如聚(羟甲基甲基丙烯)之类的固化成坚硬状态的流质材料，以及药品，或两者的组合，以提供对骨密质的改进的内部支持，或者提供其它的治疗作用，或者两者兼有之。挤压骨松质36也在骨密质38上作用内力，使之可以抬高或者推动破裂或者压缩的骨回到其骨折前原有的，或者其它所希望的，状态。
III.器械
图4示出器械，安排成工具盒200，它们可以彼此配合使用以复位骨折。器械的数量和种类可以不同。图4示出七个代表性的器械，各有不同的大小和功能。
图4中，工具箱200包括用于穿透软组织和骨的填充器械12；起引导鞘作用的经皮插管14；用于钻入骨内的钻头器械16；用于复位骨折并且插入骨内设计用于接受可扩张结构的骨折复位插管18；起把填充材料99发送进骨中的腔35的作用并且载有可在骨内膨胀的可扩张结构86的挤压器械80；起把剩余的骨填充材料迫入骨内的作用的填实器81；和带有容纳器械12、14、16和18的凹陷的手柄13。
器械12、14、16和18具有共同的特征，尽管在使用时它们设计用于执行不同的功能。器械12、14、16和18各含有具有近端42和远端44的，细长的、圆柱形体40。器械12、14、16和18各由刚性的，外科等级塑料或金属材料制造。
A.填充器械
第一器械12起填充装置的作用。如图5所示其远端44是锥形的以产生穿刺面50。在使用时，穿刺面50设计用于响应医生在近端42施加的推力和/或扭转力穿透软组织和/或骨。在一个优选实施中，填充器械12的近端42与手柄13配合，这在后文将作详细说明。
填充器械12的近端42产生一凸缘面52。凸缘面52设计用于牢靠地配合进手柄13中的凹陷内，使得在填充器械12的近端42施加的推力和/或扭转力不推移填充器械12。凸缘面52沿近端42的方向从较大的外径渐细到较小的外径。凸缘面52包括一列周绕地间隔开的齿54，所述的周绕地间隔开的齿带有中间凹槽56。
内膛60从远端44至其近端42延伸过填充器械12。优选，内膛60的尺寸做得可以容纳辅助其布设的常规手术引导针108部件，如在后文所作的详细说明。
填充器械12具有尺寸做得术者可以要填充器械12上滑动经皮插管14的外表面142。
B.经皮插管
第二器械14起经皮插管或者引导鞘的作用。它还起对钻头16保护软组织及神经、韧带、肌肉和血管的作用，这在后文将作详细说明。
如图6所示，经皮插管14在直径大于，却不长于，填充器械12。在一个实施中，插管14约2英寸长，尽管它可以有不同的其它长度，这取决于手术位置患者软组织的厚度。优选经皮插管14由金属制造，并且沿其外表面142上有标志指示它置于患者的桡骨远端24中的深度。
如图6所示，经皮插管14的近端42产生一凸缘面52。凸缘面52设计用于牢靠地配合进手柄13中的凹陷内，使得在经皮插管14的近端42施加的力不推移经皮插管14。锥形的凸缘面52沿近端42的方向从较大的外径渐细到较小的外径。经皮插管14的锥形凸缘面52包括一列周绕地间隔开的齿54，所述的周绕地间隔开的齿带有中间凹槽56。经皮插管14上的齿56和凹槽56相应于骨折复位插管18上的齿54和凹槽56的形状和方向。
如图6所示，经皮插管14包括内膛60，所述内膛60从其远端44延伸至其近端42。优选，内膛60的尺寸做得可以接受器械12。内膛60的尺寸使医生能够相对于填充器械12滑动和转动经皮插管12，并且反之亦然，如在后文所作的详细说明所述。
经皮插管14的远端44产生端面62。优选，所述远端44的所述面设计用于穿透软组织。在使用时，经皮插管14的端面62旨在，响应施加在近端42上的推力和/或扭转力，穿透填充器械12周围的软组织。如果希望，端面62可以包括一或者多个把插管14固着在目标骨的表面上的齿(未示)。
C.钻头器械
第三器个械起钻头作用。如图7所示，钻头器械16具有与填充器械12总体上相同的物理尺度。与填充器械12相似，钻头器械16旨在，在使用中适于在经皮插管14的内膛60内进行滑动和转动。
钻头器械16的远端44包括机制的切削刃64，如图7所示。在使用时，切削刃64旨在响应于钻头器械16的近端42上施加的旋转和纵向荷力穿透硬组织。
如图7进一步所示，近端42产生锥形的凸缘面52，实质上与图5所示的填充器械12上的凸缘52相同。凸缘面52设计用于牢靠地配合进手柄13中的凹陷内，使得在钻头器械16的近端42施加的力不推移钻头器械16。与填充器械12相似，锥形的凸缘面52沿近端42的方向从较大的直径变化成较小的直径。钻头器械16的锥形凸缘面52也包括一列周绕地间隔开的齿54，所述的周绕地间隔开的齿带有中间凹槽56。钻头器械16上的齿56和凹槽56相应于填充器械12上的齿54和凹槽56的形状和方向。
D.骨折复位插管
第四器械起骨折复位插管18的作用。如图8所示，骨折复位插管18有些在直径上小于，但是长于，经皮插管14。在一个实施中，骨折复位插管18约31/2英寸长，尽管它可以有不同的其它长度，这取决患者的身高和目标骨内所希望的位置。与填充器械12和钻头器械16两者都相似，骨折复位插管18旨在，在使用中适于在经皮插管14的内膛60内进行滑动和转动。
骨折复位插管18的近端42产生凸缘面52。凸缘面52设计用于牢靠地配合进手柄13中的凹陷内，使得在填充器械12的近端42施加的力不推移骨折复位插管18。与经皮插管14相似，凸缘面52沿近端42的方向从较大的外径渐细到较小的外径。经皮插管14的锥形凸缘面52包括一列周绕地间隔开的齿54，所述的周绕地间隔开的齿带有中间凹槽56。
骨折复位皮插管18的尺寸做得可以配合进经皮插管内膛60。所述内膛60的尺寸使医生能够相对于经皮插管14滑动和转动骨折复位插管18，并且反之亦然，如在后文所作的详细说明所述。
如图8所示，骨折复位插管18包括形成从骨折复位插管18的远端44延伸至其近端42的内膛68的侧壁66。内膛68用于让可扩张结构等等能够通过。如图10a所示，在一个实施中，所述内膛68的远端44是实的。在一个变通实施中，所述内膛68的远端44不是实，而是开孔以容纳诸如引导针108之类的器械的通道，如图10b所示。在另一个变通中，膛孔68的远端可以是空心的，从而可扩张结构的一部分能够伸进插管18的远端44。
骨折复位插管18还包括在侧壁66中的周绕的开口70。在一个实施中，该周绕的开口70沿其纵轴延伸一个半英寸长，然而，该开口的大小可以是不同，这取决于目标骨的尺寸和可扩张结构86的大小。周绕的开口70的尺寸做得能够容纳可扩张结构86。周绕的开口70优选还让填充材料99能够布置在骨折位置的附近和/或骨折位置内。
图8A示出根据本发明学说构成的骨折复位插管18A的变通实施。因为揭示的许多部件与前述相同，下面用同样的标号标示相同的部件。在该实施中，插管18A的远端44A不是实的；而是沿侧壁66A延伸，带有一或多个纵向延伸的齿，布置在远端44A上。
E.手柄
手柄13，可以用模制或者浇铸的刚性塑料或金属材料制造，它在1998年1月27日归档的美国专利申请09/014,229上更充分地说明了，上述申请揭示的内容在本文引作参考。如图14中所示，手柄具有平坦的上侧17。其下侧侧含有凹陷15和19。填充器械12的凸缘表面、钻头器械16、经皮插管14和骨折复位插管18与手柄13配合。凹陷15用于接受填充器械12和钻头器械16，而凹陷19用于接受骨折复位插管18。如果希望，可以设其它的把尺寸做得以相似的方式接受经皮插管14的凹陷(未示)。
F.骨挤压和/或推移器械
图11示出用于介入骨以挤压骨松质36和/或推移骨密质38的器械80。器械80和其组装指导，在美国专利申请09/420,529中充分地给出，该申请于1999年10月19日归档，在此引作参考。
器械80包括导管组件82，如图11所示。导管组件82的远端84载有可扩张结构86。在使用时，可扩张结构86布设和膨胀于骨内部，例如在桡骨20内部，如图20、21及22所示，以挤压骨松质36和/或推移骨密质38，如下文所述。
如图11进一步所示，器械80包括外导管体88，和穿外导管体88延伸的内导管体90。外导管体88和内导管体90的近端92连接成Y字形适配器/手柄94。Y字形适配器/手柄94在其近端92承载第一口96和第二口98。第一口96用于连接充胀注射器101，所述注射器101在本例中用于向可扩张结构86中发送加压液体。第二口98用于插入强化芯针(未示)以帮助插入器械80的远端84。
如图11所示，可扩张结构86于其近端95连接外导管体88的远端。类似地，可扩张结构86于其远端87连接内导管体90的远端84。
外导管体88成内导管体90空过它延伸的内膛。在使用时，所述的内膛把加压的液体，例如CONRAY(R)液之类的不透放射性的溶液，或其它液体输送进可扩张结构86以膨胀之。
用于制造可扩张结构86的材料应当具有各种物理和机械特性以优化其挤压骨松质36和移动骨密质38的作用能力。优选，可扩张结构86具有把骨密质38从骨折的状态移动到骨折前的状态，或者其它所希望的状态，或两者兼有之，的能力。可扩张结构86的三个最重要的特性是膨胀其体积的能力；在膨胀时经所希望的方式形变并且在骨内采取所希望的形状的的能力；以及在与骨松质36接触时耐磨损、抗牵拉和抗刺透的能力。
对结构材料所希望的特性，以及产生预成形结构的说明，在美国专利申请09/420,529中充分地给出。
如图11所示，可扩张结构86载有不透射线的标记91，位于可扩张结构86的分段形区域100的远端102和近端104。不透射线的标记91用作在X线透视或其它实时监视下指示分段形区域100相对于骨折复位插管18的位置。
图12示出处于未膨胀状态(实线)的可扩张结构并且示出膨胀状态(虚线)的可扩张结构。
G.牵引针
可以设一或多个常规的光滑斯坦曼牵引针130或者基尔希讷氏(“K”)钢丝帮助对齐和/或稳定断骨，这在下文将加以详细说明。
H.材料填充器械
填充材料99器械包括如图13所示的填实器81和标准注射器。通过注射器把填充材料99引入骨折复位插管18。剩余的填充材料99可通过应用填实器81迫经骨折复位插管18，这在下文将加以较详细说明。
I.工具盒
如图4所示，提供有工具盒200，包括器械12、13、14、16、18和81.工具盒200和含于其中的器械进行灭菌，然后一直密封到使用前。
IV.系统的示例性使用
要使用的介入工具和/或可扩张结构86的大小和形状，以及要移动的骨量，优选由医生考虑受治疗位置的形态和几何特点进行选择。关节的形状、所涉及骨和软组织，及不适当地移动可能会造成危害的局部结构，一般地是医务人员参照人体解剖教科书结合对该位置及其病患和/或损伤能够理解的。医生还优选能够使用例如x-线平片、x-线透视，或者MRI或CT扫描，基于对目标骨和关节的事先分析选择可扩张结构所希望的形状和大小、腔35以及其位置。优选选择把所述形状、大小和位置选择得优化强度和最终对关节的周围骨和/或组织粘接骨折。
在典型的手术操作中，患者受局部麻醉剂，然而也可以采用全身麻醉代之。骨折是桡骨骨折时，医生在桡骨远端24的远方约一厘米进行切口。在一个变通的实施中可以通过经尺骨26抵达介入桡骨远端。切口与骨折34之间的距离约0.5厘米。当然就最小侵入性手术方面而言说明本术时，可以根据本发明的学说采用各种其它的外科方法，包括经皮、皮下、不开放、局部开放和/或完全开放的手术方法。
做切口后，医生使用小夹钳分布软组织，所述小夹钳设计用于避免损伤附近神经、肌肉以及血管。医生然后取得填充器械12和手柄13。填充器械12可在其近端42具有与手柄13内的凹陷15配合的凸缘面52。使用带有填充器械12的手柄13既可以产生径向运动也可以产生轴向运动，如在美国专利申请09/014,229中所示，该申请于1998年1月27日归档。然后，医生把填充器械12的近端12装配进手柄13中的手柄15，如图15a所示。医生还可以叩击手柄13，或者以其它方式向手柄13施加适当的附加纵向力，以经软组织推进填充器械12。
接着医生扭动手柄13同时向手柄13施加纵向力。与之响应，填充器械12的锥形面经切口旋转并且穿透软组织和/或骨，如图15a所示。
在x线透视监视或者其它的实时监视下，医生经软组织向下向桡骨远端24推进填充器械12，如图15a所示。填充器械12从远向近从桡骨20的桡侧向桡骨20的尺侧插入。把填充器械12引入桡骨20中。优选地，以对桡掌关节负10度至45度之间的角引入填充器械12。更优选地，以等于桡掌关节角的角度，即约23度的角引入填充器械12。最优选地，以对桡掌关节0度至30度之间的角引入填充器械12。当然，如果愿意，医生可用各种其它进入路径介入骨，包括背侧进入方法。
医生接着从填充器械12卸下手柄13，然后把经皮插管14的近端42置于手柄13的中的凹陷19内。医生在填充器械12上，从远端44开始滑动经皮插管14。医生扭动手柄13同时向手柄13施加纵向力，以把经皮插管14放置得抵着和/或进入外部的骨密质39，如图16所示。一旦经皮插管14处于骨密质38中，就取走填充器械12，从近端24开始。
在一个变通实施中，不用填充器械12介入的骨密质38，医生可代之以向骨插入常规的脊椎穿刺针，所述穿刺针具有外部套针和芯针。穿透了骨后医生取走芯针然后经外套针插入引导针108。然后医生把经皮插管14的近端42装配进手柄13的中的凹陷19内。医生然后在骨折复位插管18上，从远端44开始滑动组件，如图28所示。接着从近端开始取走引导针108。
在取走填充器械12后，或者在上述变通实施发问下取走引导针108之后，从经皮插管14上卸下手柄13。如图15所示，然后把钻头器械16的近端42置于手柄13的凹陷中。钻头16的优选尺寸是3.2毫米。使用手的压力把钻头器械16向下推进到桡骨远端24内。作为变通实施，不用手压力，医生马钻头器械15的近端42连接到常规的电动钻上。医生引导钻头器械16穿透桡骨远端的骨密质38和骨松质36，如图17所示。
钻穿骨密质38和进入骨松质36以后，医生从手柄13上取走钻头器械16。然后，远端44在前地，向以皮插管14内插入骨折复位插管18。骨折复位插管18的远端44伸过经皮插管14的远端44。在一个变通的实施中，医生可在此时取走经皮插管14，而只把骨折复位插管18留住不动。在一个实施中，优选地采用知其远端44有螺纹71的骨折复位插管18，如图9所示，从而使骨折复位插管18能够响应，例如使用手柄13造成的骨折复位插管18的旋转锚着在骨密质38内。在一个变通的实施中(参见图8B)，医生采用具有钝的，锥形的远端44的骨折复位插管18，取代其远端上的螺纹。如果使用这样的骨折复位插管18，医生可选择在骨密质38中钻一个孔，以在其中安放钝的、锥形的远端44。优选，如果远端44是钝和锥形的，骨折复位插管18可以用于独立于远端44转动。作为另一个变通，可以把图8A中所示的插管18A插入到目标骨中，如前所述，用齿120把插管18A的远端44A锚着在目标骨的骨密质壁(未示)上。用此实施，可不需要经密质骨壁钻孔去固附插管18A的远端44A.
在另一个实施中，可以直接经目标骨中的一或多个骨折线直接地做介入通道。这样的安排把对骨折骨的损伤最小化(通过对减少对较正常的目标骨的附加损坏达到)并且使之能够产生延伸到骨折线的每侧的腔35。
把骨折复位插管18置入桡骨远端24的骨松质中从而把周绕的开口80对着骨折，如图18所示。放射线核查骨折复位插管18以确保周绕的开口70完全地含在桡骨20的骨松质38内。在一个实施中，可以在插管18的近端42上设一或多个标记(未示)，让医生可以视觉地测定插管18的方向。在一个实施中，骨折复位插管18的长度约为3至4英寸。
医生现在可以取得导管组件83，以置入骨折复位插管18的膛孔68内，在一个实施中导管承载的未充胀的可扩张结构86从其近端至其远端长度为12毫米，然而可以使用不同长度的结构86，包括15毫米或20毫米的可扩张结构，这要取决于患者的个头、骨折的大小和位置、开口70的和腔35大小和形状和/或所希望的骨头70位移。现在把导管组件82引入骨折复位插管18的膛孔68内。
医生经骨折复位插管18引导导管组件82直到可扩张结构86进入和邻接骨折复位插管18的周绕的开口70，如图20所示。在一个实施中，骨折复位插管18的远端44是实的，如图9所示，从而防止可扩张结构86从骨折复位插管18远端44露出。可扩张结构86在周绕的开口70中的位置可以由位于可扩张结构86上的不透射线的标记91确定，如图11所示。以常态的塌陷的或称未充胀的状态经骨折复位插管18把可扩张想方设法86递送进骨内。现在可扩张结构86与骨松质对齐。
证实可扩张结构86邻接周绕的开口70以后，医生把把加压的液体，譬如不透放射性的溶液，经导管组件82输送，并且输送进可扩张结构86。现在可扩张结构86膨胀直骨松质36如图21所示。骨折复位插管18优选向骨折34引导膨胀着的结构86。可扩张结构86的进度用A-P位也就是前后位，和侧位x线两者评估。优选地把A-P位x线一直使用到桡骨20的远端24开始移动，在此时同时得到A-P位和侧位x线。用加压液体充胀可扩张结构86并且经周绕的开口70膨胀它，以压迫骨松质36和/或移动骨密质38。优选，可扩张结构86将在骨松质36中形成内腔35，如图24所示。优选，受压的骨松质36将密封目标骨内的，后文说明的填充材料99可经之流出目标治疗区的所述骨折处34和/或裂纹。
如图22所示，压迫骨松质36还可以在周绕的骨密质38上施加内力。所述内力将抬起或者推动压缩的内返回到或者接近其原来的骨折前，或者其它的所希望的状态。一旦骨折34对齐良好，优选地向桡骨20的关节面和充胀的可扩张结构86的远端引入一或多个光滑的斯坦曼牵引针130或者K式钢丝。牵引针130可以跨桡骨20的远端24放置并且放进尺骨远端30，如图22和24-27所示。变通地，牵引针130可以固定进桡骨20而不穿透尺骨26。优选地牵引针防止在进一步操作腕和/或收缩可扩张结构86时骨折处34移位。如果希望，可以用附加的牵引针130操作和/或固定其它的骨密质骨片，以用于进一步固定单个的骨片。
在一或多个变通地实施中，可以在把骨片推移到以前的位置，然而没有完成充胀步骤前，引入牵引针130。例如，在球囊的充胀把骨片推移到所希望的位置，却希望产生附加的腔的时候，可以用一或多个牵引针130把骨片固定在位，然后把球囊进一步充胀以产生较大的腔35和/或压迫另外的骨松质36.
如图23所示，在一个优选的实施中，患者受累手臂的手指可以置于水平的指套132中，同时把患者的手掌面对手术台。可以在患者的腕下放置毛巾卷133.通过抓握指套132和轻拉指套，医生可以伸展患者的手臂，从而降低任何可作用在骨折处的压力。这种方法可以潜在地使得能够矫正桡骨远端24的的掌跖倾斜(15度角)。如果希望，这可以在骨折复位前、骨折复位过程中或者骨折复位完成后进行。
一旦形成内腔35和把所有希望的牵引针130固定在位后，把可扩张结构86松塌，然后与松塌的可扩张结构86一起取走导管组件82。如图27所示，现在腔35处于经骨折复位插管18接收填充材料99的状态。填充材料99可以任何数量市售骨填充材料，包括，但是不限于，可重吸收和/或可重模制的骨水泥、碳酸钙，异体移植组织、自体移植组织、聚(羟甲基甲基丙烯)或者SRSTM骨基质。可以用注射器(未示)把填充材料引入骨折复位插管。填充材料99经骨折复位插管18前进并且进入骨折复位插管18的周绕的开70。填充材料99优选地对骨密质提供改进的内部结构支持。优选地，填充材料99近端地延伸到由钻头器械16和由骨折复位插管18产生的所有密质缺损处。在一个实施中，可以向腔35内注入约二(2)至七(7)立方厘米填充材料99。
引入填充材料99后，可以把填实器81插入到骨折复位插管18中如图26所示，旨在把简便的填充材料99迫入内腔35中。填实填充材料99还可引起材料结合进周围的骨松质36中，进一步支持骨松质36和骨密质38。取走骨折复位插管18和(如果还在)经皮插管14。如果希望，可以把因取走骨折复位插管18留下任何空隙中填充以填充材料99。应当保持患者十至十五分钟不动。在固定后，可以取走牵引针130和指套132，然后检查患者手的运动。在整个位置上覆盖适当的抗生素，然后贴以胶带。
图21A和图22A示出一个变通地实施，其中在折骨中膨胀可扩张结构86，以产生伸过骨中至少一个骨折裂纹的腔35.在此实施中，最终引入腔35中的填充材料99可以跨该骨折裂纹延伸并且优选地进入断片的骨松质中。这将优选地把折断部分锚着在骨上，从而使骨能够经受显著的拉负荷和/或扭力负荷而没有沿骨折裂纹的滑动和/或造成治疗后内的再骨折。
如果希望，本文揭示的系统和方法可以以等同的形式用于年青个体和/或没有骨质疏松的个体复位和/加固骨折。在这样的患者中，本发明的系统和方法能够让患者立即恢复活动，降低相邻关节退化的机会，以及骨折愈合。
本发明的特征要权利要求书中给出。

Claims (4)

1.用于挤压骨松质的器械，包括：
外导管体，具有远端；
内导管体，具有远端并且延伸通过所述外导管体；以及
可扩张结构，具有：近端，连接至所述外导管体的远端上；以及远端，连接至所述内导管体的远端上。
2.根据权利要求1所述的器械，
所述可扩张结构还具有：第一扩张区段，具有与所述可扩张结构的近端相邻的内横截面面积；第二扩张区段，具有与所述可扩张结构的远端相邻的内横截面面积；第三扩张区段，具有在所述第一扩张区段与所述第二扩张区段之间的内横截面面积；
其中所述第三扩张区段的内横截面面积小于所述第一扩张区段或者所述第二扩张区段的内横截面面积。
3.根据权利要求1所述的器械，进一步包括插入到所述内导管体中的芯针。
4.根据权利要求1所述的器械，进一步包括不透射线的标记。
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