CN108882953B - 骨搬移用的系统 - Google Patents

骨搬移用的系统 Download PDF

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CN108882953B
CN108882953B CN201780020777.6A CN201780020777A CN108882953B CN 108882953 B CN108882953 B CN 108882953B CN 201780020777 A CN201780020777 A CN 201780020777A CN 108882953 B CN108882953 B CN 108882953B
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bone
length
adjustable implant
support member
implant
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CN108882953A (zh
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J·舒瓦尔特
M·默勒
托马斯·B·比福德
V·索玛赛迦蓝
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Nuvasive Specialized Orthopedics Inc
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7216—Intramedullary pins, nails or other devices for bone lengthening or compression
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Abstract

提供一种骨搬移用的系统，所述系统包括长度可调节的植入体，该长度可调节的植入体构造成用于髓内放置并且包括：构造成联接至骨的第一端以及构造成联接至骨的第二端，其中，所述第一端与所述第二端能沿纵轴线相对于彼此移位；驱动元件，该驱动元件构造成被非侵入地启用成使所述第一端与所述第二端沿所述纵轴线相对于彼此移位；以及支撑构件，该支撑构件具有远端与近端，其中，所述支撑构件包括布置在所述支撑构件的所述远端与所述近端之间的纵向延伸槽，所述槽具有相对的两端，其中，所述槽构造成越过细长锚使得所述细长锚能在所述槽的第一端与所述第二端之间滑动。

Description

骨搬移用的系统
相关申请的交叉引用
本申请要求2016年1月28日递交的临时申请号为62/288348的未决美国临时专利申请的优先权以及权益。
背景技术
牵引骨生成术是一种已经用于在具有各种各样缺陷的患者中生长新骨的技术。例如，肢体延长术是一种可以增加骨(例如，股骨或者胫骨)的长度的技术。在骨中创建骨皮质切开或者截骨(穿过骨的切口)之后，产生的骨的两个部分可以以诸如每天一(1.0)毫米之类的特定速率移开。当骨的这两部分移开时可以在这两部分之间再生新骨。在一个肢体比另一肢体长(例如，在先前断骨没正确愈合的患者中或者在生长板在成熟之前患病或者受损的患者中)的情况下可以使用此肢体延伸的技术。在一些患者中，期望身材延长从而可以通过延长两个股骨以及/或者两个胫骨以增加患者的高度而实现身材延长。
骨搬移在利用骨生成方面是一种类似的手术。但是，代替增大骨的端部之间的距离，骨搬移填充其间的缺失骨。显著量的骨可能缺失的原因有若干。例如，先前不连的骨(诸如由于断裂)可能感染，因此有必要移除感染的部分。而且，当骨的大部分严重受损时，可能存在节段性骨缺损，缺损往往由于严重外伤引起。
其它类型的骨感染或者骨肉瘤可能需要移除大块骨(导致部分天然骨缺失)。
历史上，常利用外固定进行肢体延长。外固定过程涉及外牵引架，该外牵引架借助穿皮针(即，穿过皮肤)附接至骨的两个(或者更多个)分离部分。基于针的方法有若干缺点。针可能是引起感染的场所并且对于患者而言往往是疼痛的，因为针放置位置在整个治疗过程留有一些开放性伤口“针道”。而且，外固定架笨重，并且会使得患者难以舒适地坐、睡觉以及移动。还存在髓内延长装置，例如通过引用合并于此的申请号为12/875585的美国专利申请中描述的那些髓内延长装置。
或者借助外固定或者借助骨移植频繁地进行骨搬移。在外固定骨搬移中，从骨的余留部分切割骨节段并且借助外固定移动(通常以接近每天1(1.0)mm的速率)，直到产生的再生骨填充缺损为止。由基于外固定的骨搬移过程中的针道创建的伤口常常比由外固定肢体延长过程创建的伤口更糟。随着针相对于皮肤移动针使伤口开得更大。在骨移植中，自体移植(来自患者)或者异体移植(来自另一人)常用于创建用于新骨生长的晶格。骨移植可能比外固定针的放置更复杂并且/或者代价更高。
发明内容
本公开提供一种用于搬移具有不完整的骨的患者内的骨的一部分的方法，该方法包括：提供一种长度可调节的植入体，该长度可调节的植入体构造成用于髓内放置并且具有构造成联接至骨的第一端以及构造成联接至骨的第二端，其中，所述第一端与所述第二端能沿纵轴线相对于彼此移位；将长度可调节的植入体至少部分放置在对象的骨的髓管内，骨具有第一端以及第二端并且具有至少第一部分以及第二部分，第一部分与第二部分之间具有间距，骨的第一部分包括骨的第一端并且骨的第二部分包括骨的第二端，通过分离骨的第一部分或者骨的第二部分中的至少一部分创建骨的第三部分，其中，骨的第三部分不包括骨的第一端或者骨的第二端；通过将支撑构件的第一端联接至骨的第一部分的外表面并且将支撑构件的第二端联接至骨的第二部分的外表面而将具有第一端以及第二端的支撑构件联接至骨；将长度可调节的植入体的第一端联接至骨的第一部分以及第二部分中的一者，将长度可调节的植入体的第二端联接至骨的第三部分，其中，长度可调节的植入体包括驱动元件，该驱动元件构造成被非侵入地启用成使长度可调节的植入体的第一端与第二端之间的距离被受控改变，使得骨的第三部分沿纵轴线相对于骨的第一部分以及第二部分移动，而骨的第一部分以及骨的第二部分不相对于彼此移动。
本发明另外提供一种骨搬移用的系统，该骨搬移用的系统包括：长度可调节的植入体，该长度可调节的植入体构造成用于髓内放置并且包括：构造成联接至骨的第一端以及构造成联接至骨的第二端，其中，所述第一端与所述第二端能沿纵轴线相对于彼此移位；驱动元件，该驱动元件构造成被非侵入地启用成使长度可调节的植入体的所述第一端与所述第二端之间的距离能沿所述纵轴线被受控改变；以及支撑构件，该支撑构件具有第一端以及第二端，其中，所述支撑构件包括布置在所述支撑构件的所述第一端与所述第二端之间的纵向延伸槽，所述槽具有第一端以及第二端，其中，所述槽构造成越过细长锚使得所述细长锚能在所述槽的第一端与所述第二端之间滑动。
本公开进一步提供一种用于搬移具有不完整的骨的患者内的骨的一部分的方法，该方法包括：提供一种长度可调节的植入体，该长度可调节的植入体构造成用于髓内放置并且具有构造成联接至骨的第一端以及构造成联接至骨的第二端，其中，所述第一端与所述第二端能沿纵轴线相对于彼此移位；将长度可调节的植入体至少部分放置在对象的骨的髓管内，骨具有第一端以及第二端并且至少具有第一部分以及第二部分，第一部分与第二部分之间具有间距，骨的第一部分包括骨的第一端并且骨的第二部分包括骨的第二端，通过分离骨的第一部分或者骨的第二部分中的至少一部分而创建骨的第三部分，其中，骨的第三部分不包括骨的第一端或者骨的第二端；将外部固定器联接至骨，外部固定器具有外基部、第一销以及第二销，通过将外部固定器的第一销联接至骨的第一部分并且将外部固定器的第二销联接至骨的第二部分，将长度可调节的植入体的第二端联接至骨的第三部分，其中，长度可调节的植入体包括驱动元件，该驱动元件构造成被非侵入地启用成使长度可调节的植入体的第一端与第二端之间的距离被受控改变，使得骨的第三部分沿纵轴线相对于骨的第一部分以及第二部分移动，而骨的第一部分以及骨的第二部分不相对于彼此移动。
附图说明
图1至图2示出了构造成用于骨搬移的髓内装置的各个图。
图3示出了沿线3-3剖取的图2的髓内装置的剖面图。
图4A示出了图3的详细视图4。
图4B示出了髓内装置的另一实施方式的剖面图。
图4C示出了图4B中所示的装置的齿圈嵌件。
图4D示出了图4B中所示的装置的联接器组件。
图5示出了图1至图4A中所示的髓内装置的分解视图。
图6示出了图5的详细视图6。
图7示出了髓内装置的另一实施方式的剖面图。
图8示出了图7的髓内装置的维持构件。
图9至图12示意性示出了髓内装置的各个驱动元件。
图13示出了一部分缺失了的骨。
图14示出了联接至骨的用于骨搬移的系统。
图15示出了搬移了骨的一部分之后的图14的系统。
图16示出了以逆行方式联接至骨的用于骨搬移的系统。
图17示出了搬移了骨的一部分之后的图16的系统。
图18示出了外部调节装置。
图19示出了图18的外部调节装置的磁性手柄的分解视图。
图20示出了用于骨搬移的系统的另一实施方式。
图21示出了联接至骨的图20的系统。
图22示出了搬移了骨的一部分之后的图21的系统。
图23示出了用于长度可调节的植入体的套件。
图24示出了由图23的套件构建的长度可调节的植入体。
具体实施方式
本文中公开了能够改变或者影响/作用于患者的骨骼系统的一部分的用于植入到身体中的各种可调节装置。在一些实施方式中，可调节植入体构造成用于搬移骨节段以更换骨的损失部分。还提供用于使用用于搬移骨节段以更换骨的损失部分的可调节植入体的方法。在一些实施方式中，该方法可以包括一个或者多个板。可调节装置可以包括牵引或者缩进装置，例如构造成用于整形外科应用(包括但不限于脊柱侧凸、肢体延长、骨搬移、棘突牵引、腰椎前凸调整、胫骨高位截骨调整以及脊椎滑脱)的牵引或者缩进装置。构造成用于骨搬移的可调节装置可以包括髓内肢体延长装置。
图1与图2示出了包括牵引杆302以及壳304的髓内装置300(例如，髓内延长装置)。如可以在图3的剖面图中更好地理解到的，壳304在第一端310与第二端312之间延伸。壳304可以形成为没有接缝或者接头的一元结构。另选地，壳304可以由在接缝或者接头处融合在一起的多个零件形成。如图3中所示，牵引杆302具有第一端318以及第二端320，并且构造成相对于壳304(例如，在壳304内)可伸缩地延长及缩进。与壳304相同，牵引杆302可以是没有接缝或者连接各个子部件的接头的一元结构。另选地，牵引杆302可以由在接缝或者接头处融合在一起的多个零件形成。牵引杆302与壳304两者可以由包括钛(例如，钛-6AL-4V)、钴镍合金以及不锈钢在内的多种生物相容性材料中的任何材料制成。因为牵引杆302与壳304是髓内装置300的主要载荷支承构件，并且因为都没有外周焊缝，所以髓内装置300相比传统的髓内肢体延长装置能够承受提高的负载挑战。壳304包含用于供髓内装置300附接至骨之用的骨螺钉穿过的至少一个横向孔(例如，两个横向孔301)。牵引杆302包含也用于骨螺钉穿过的至少一个横向孔(例如，三个横向孔303)。如将容易理解的，横向孔301、303的数量以及取向可以根据关于任何既定应用的需要、用途或者期望变更。联接特征323在壳304的第二端312处提供与诸如钻导引器之类的嵌入仪器可释放地接合的界面。钻导引器可以包括阳螺纹并且联接特征323可以具有互补或者匹配的阴螺纹。髓内装置300包括磁体338，该磁体结合在磁体壳340内并且构造成用于在径向轴承344与推力轴承342(图4A中更清楚地示出)之间旋转。至少一个行星齿轮级(例如，如图4A中看到的，三个行星齿轮级305、307、309)位于推力轴承342与磁体壳340之间。各个行星齿轮级(例如，行星齿轮级305、307、309)均包括太阳齿轮(例如，太阳齿轮311A、311B、311C)以及多个行星齿轮(例如，三个行星齿轮313)，这些行星齿轮借助销317被可旋转地保持在框架315内。太阳齿轮311或者是磁体壳340的一部分(如行星齿轮级305的太阳齿轮311A的情况下)，或者是框架315的一部分(如齿轮级307的太阳齿轮311B以及齿轮级309的太阳齿轮311C中)。太阳齿轮311的旋转引起行星齿轮313沿齿圈嵌件319的内齿321旋转并且跟踪内齿321。各个齿轮级均具有齿轮减速比(例如，4:1)，这产生了一个总齿轮减速(例如，64:1的总齿轮减速，由各具有4:1的减速比的三个行星齿轮级305、307、309提供)。应理解，可以使用其它齿轮减速以及其它数量的级。
最后的齿轮级(例如，齿轮级309)的框架315穿过推力轴承342并且附接至导螺杆联接器366，使得最后的齿轮级309的框架315的旋转引起导螺杆联接器366的一对一旋转。导螺杆联接器366与导螺杆358均包含横向孔，锁定销368穿过这些横向孔放置，因而将导螺杆358可旋转地联接至最后的齿轮级(例如，齿轮级309)。锁定销保持器350在导螺杆联接器366上滑动并且固定(例如，定位焊接)至该导螺杆联接器以径向维持/保持锁定销368就位。牵引杆302具有内螺纹端363，螺母360的外螺纹365旋拧到内螺纹端363中并且例如借助环氧树脂结合到内螺纹端363中。螺母360具有内螺纹端367，内螺纹端367构造成可旋拧地与导螺杆358的外螺纹325接合，因而允许导螺杆358沿第一方向的旋转相对于壳304牵引或者延伸牵引杆302。导螺杆358沿第二(相反)方向的旋转相对于壳304缩进或者撤回牵引杆302。磁体338以及磁体壳340的旋转引起导螺杆旋转。取决于所包括的齿轮传动装置，磁体338以及磁体壳340的旋转能够引起导螺杆358以1/64的旋转速度但以显著增大的转矩(64倍，减去摩擦损失)旋转，因此具有增强的牵引或者延伸力。O形环362放置在牵引杆302的外部上的环形槽388中以创建壳304与牵引杆302之间的动态密封，这保护内容物免受体液。位于牵引杆302与导螺杆联接器366之间的开口垫圈止挡364防止当牵引杆302逼近导螺杆联接器366(例如，在髓内装置300借助高转矩(例如，由外部移动磁场施加的高转矩)充分缩进的情况下)时可能引起的卡滞。
包括由导磁材料(例如，400系列不锈钢)制成的曲面板的维持构件346固定至/结合(例如，使用环氧树脂、粘合剂、电阻焊或者其它合适的过程)在壳304的内壁内。维持构件346吸引磁体338的磁极，因此避免肢体延长装置300被患者的移动意外调节。然而，诸如由现有技术中公知的磁力调节装置施加的磁场之类的强大的移动磁场能够克服磁体338对维持构件346的吸引，旋转磁体338，因而调节髓内装置300的长度。维持构件346可以具有大约0.015英寸的厚度并且能跨越小于约180°的圆弧(例如，99°的示例性弧)。当然，可以构想维持构件346的其它尺寸，只要该尺寸对磁体338提供足够的吸引力以在没被致动时将其合适地保持就位即可。
牵引杆302与壳304可以例如借助结合手动或者自动车床的机加工过程被分别制造。壳304内轴向延伸腔的形成可以包括在此制造操作内。后处理可以包括在此操作中，例如喷丸处理、钝化处理以及/或者阳极氧化处理。然后，准备牵引杆302与壳304进行匹配。在此操作中，将螺母360结合到牵引杆302中并且如描述的O形环362放置到环形槽388中。将维持构件346结合到壳304中。然后，将磁体338放置到壳304的腔390中。在此操作中，磁体338与磁体壳340结合在一起，然后借助径向轴承344组装到壳304中(参见图3)。在将径向轴承344组装到壳304中之前，测量壳304的腔390的纵向深度，并且如果需要，则可以在径向轴承344之前放置一个或者多个垫片。理想地，组装部件中的轴向游隙不低到引起咬合，然而不高到有拆卸的危险。接着，导螺杆358准备联接至位于壳304的腔390中的磁体338。在此操作中，齿圈嵌件319滑动到壳304的腔390中直到它抵接凸耳392。然后，如图4A中看到的，将第一行星齿轮级305与第二行星齿轮级307放置到该组件中。在导螺杆联接器366焊接至最后的行星齿轮级309之前将锁定销保持器350预加载到导螺杆联接器366上，然后在放置锁定销368之后在锁定销368上滑动就位。最后的行星齿轮级309插入通过推力轴承342并且焊接至导螺杆联接器366，为推力轴承342留有些许轴向游隙。然后，将开口垫圈止挡364放置到导螺杆358上。然后，8借助锁定销368将导螺杆35附接至导螺杆联接器366，然后使锁定销保持器350在锁定销368的端部的一部分上滑动并且定位焊接至导螺杆联接器366。推力轴承保持器354、356是绕推力轴承342以及导螺杆联接器366形成圆筒形蚌壳的两个匹配件。壳304的内直径用焊料镀锡，对各个推力轴承保持器354、356的外半直径表面也用焊料镀锡。接着，将推力轴承保持器354、356夹紧在包括推力轴承342、导螺杆联接器366、行星齿轮级309以及导螺杆358的组件上，并且推力轴承保持器354、356例如借助压靠推力轴承保持器354、356的倒角352的工具被一起推到壳304内的适当位置。最后的行星齿轮级309的太阳齿轮311C与最后的行星齿轮级309的行星齿轮317接合，然后推力轴承保持器354、356的斜切边缘394被推靠齿圈嵌件319的倒角348并且保持压缩力。于是，推力轴承342与磁体338被轴向保持。在此操作中，推力轴承保持器354、356在镀锡部分处焊接至壳304，从而维持压缩力。这可以利用感应加热而实现。凸耳392与斜切边缘394对齿圈嵌件319的相对的两个端部的摩擦以及斜切边缘394与倒角348之间的楔固产生旋转阻力，因此保持齿圈嵌件319相对于壳304旋转静止。另选地，齿圈嵌件319可以具有配合到壳304中的相应键特征中的键特征以便阻止齿圈嵌件319相对于壳304转动(如果/当齿圈嵌件319的端部上的摩擦不足以保持齿圈嵌件319静止时这会是有用的)。
然后，牵引杆302可以与导螺杆358接合。在此操作中，诸如高速旋转磁体之类的组装工具用于使磁体338并因此使导螺杆358旋转并且在导螺杆358接合牵引杆302的螺母360并相对于螺母360移位的同时牵引杆302被插入到壳304中。在如描述的牵引杆302插入到壳304中并且至少些许缩进之后，牵引杆302仍能相对于壳304旋转。为了正被牵引的骨块的稳固，可能期望抑制牵引杆302与壳304之间的旋转。关于图5以及图6描述了一种可行的方法以及实施该方法的结构。可以通过将每侧上各一个的突起374接合到沿牵引杆302延伸的槽372中而将抗旋转环370放置在牵引杆302上然后通过滑动抗旋转环370直到到达壳304的逐渐变细的内边缘376，从而相对于壳304旋转锁定牵引杆302。然后，可以使抗旋转环370与牵引杆302旋转直到引导翅片382能够插入(例如，滑动)到位于壳304的端部中的引导切口380中。抗旋转环370能够轴向卡合到壳304中使得抗旋转环370的平坦边缘384被底切378截留。底切378具有小于抗旋转环370的平坦边缘384的外直径的最小直径，并在卡合过程中暂时被强制打开。组装时，抗旋转环370、壳304以及牵引杆302相对于彼此都大致保持旋转静止。此外，当髓内装置300达到其最大牵引长度时，槽372的端部386抵接突起374，因而阻止牵引杆302脱离壳304。
图4B中的剖面图中示出了图1至图4A的髓内装置300的另选实施方式。此实施方式的大部分可能与图1至图4A中所示的实施方式相似或者相同。然而，此实施方式的变更至少在于无需具有推力轴承保持器354、356。相反，该实施方式可以结合具有外锥形端部347的推力轴承套圈335。推力轴承保持器337、锁定销保持器341以及推力轴承套圈335放置在推力轴承342以及导螺杆联接器339上，最后的行星齿轮级309插入通过推力轴承342并且焊接至导螺杆联接器339。如图4D中所示，锁定销保持器341具有避让部361以允许锁定销368穿过。在放置锁定销368后，锁定销保持器341可以旋转使得避让部361不再正好位于锁定销368上方并且锁定销保持器341定位焊接或者借助其它方法固定至导螺杆联接器339，从而保持锁定销368。然后，将这些组装部件插入到壳304的腔390中，在腔390中，最后的行星齿轮级309联接至其它行星齿轮级305、307以及磁体338。在此实施方式中，齿圈嵌件333(图4C)各侧具有缺口351(例如，凹口)。一旦推力轴承套圈335结合到壳304中，推力轴承套圈335的各侧上的突片349就插入到各个缺口351中从而抑制齿圈嵌件333相对于壳304旋转。而且，在此实施方式中，壳304包含内螺纹343。通过将推力轴承保持器337的外螺纹345拧紧到壳304的内螺纹中而实现推力轴承套圈335的接合。工具(未示出)可以接合到位于推力轴承保持器337的任一侧或者两侧上的切口357中并且用于将推力轴承保持器337拧到壳304的内螺纹343中。如图4B中所示，这对着推力轴承套圈335的外锥形端部347楔住推力轴承保持器337的内锥形部353，从而允许推力轴承套圈335在齿圈嵌件333上施加受控的载荷，将齿圈嵌件333相对于壳304轴向以及旋转锁定。推力轴承保持器337在相反侧具有轴向缝隙(未示出)。推力轴承保持器337中的缝隙允许推力轴承保持器337的外直径在推力轴承保持器337插入到壳304中时被拧入之前稍微减小(由于压缩)，从而在插入过程中壳304的内部不被刮擦。图4D中可以看到位于导螺杆联接器339上的凸耳355。如早先说明的，开口垫圈止挡364平接此凸耳355以在牵引杆302完全缩进时防止卡滞。
图7中的剖面图中示出了图1至图4A的髓内装置300的另选实施方式。维持构件397代替曲面板维持构件346。维持构件397相对于肢体延长装置300的壳304内的磁体338轴向隔开，但是由于其邻近磁体338，维持构件397仍能够吸引磁体338的磁极，因而阻止肢体延长装置300被患者的移动意外调节。维持构件397包括本体395以及固定部391。固定部391被示出成包括四个突片393，每个突片均具有比壳304中的腔379的半径大的外半径。突片393与腔379之间的过盈足以将维持构件397保持就位，从而维持构件397不能相对于壳304转动或者轴向移动。另选地，固定部391可以粘附结合、焊接或者借助其它手段固定至腔379。维持构件397包括凸耳381，该凸耳构造成供径向轴承344座置。类似于图1至图4D的实施方式，磁体壳340的鼻部377被按压到径向轴承344的内孔中。在图7以及图8的实施方式中，维持构件397中的通孔399构造成允许磁体壳340的凸部377的非接触延伸，因而允许磁体壳340并因此允许磁体338自由旋转。耳387、389被间隙383、385分开并且包括导磁材料(例如，400系列不锈钢、铁、μ合金或者能够吸引磁体338的磁极的其它类似材料)。各个耳387、389的边缘375可以是平坦的以便允许最大量的材料邻近磁体338定位。
图18示出了外部调节装置1180，该外部调节装置用于非侵入地调节本文中描述的装置以及系统。外部调节装置1180包括磁性手柄1178、控制箱1176以及电源1174。控制箱1176包括控制面板1182以及显示器1184，控制面板1182具有一个或者多个控制器(按钮、开关或者触感、动作、声音或光传感器)。显示器1184可以是视觉的、听觉的、触觉的等或者上述特征的某一组合。外部调节装置1180可以包含允许医师编程的软件。
图19示出了外部调节装置1180的磁性手柄1178的细节。有多个(例如，两(2)个)具有圆筒形形状的(另外，其它形状是可行的)磁体1186。在一些实施方式中，磁性手柄1178仅包括一个磁体1186。在一些实施方式中，磁性手柄1178使用一个或者多个电磁体。磁体1186可以由稀土磁体(例如，钕铁硼)制成，并且在一些实施方式中可以是径向极化的。磁体1186结合或者固定在磁屏1187内。磁屏1187均包括轴1198，一个轴附接至第一磁体齿轮1212并且另一轴附接至第二磁体齿轮1214。两个磁体1186中每一者的磁极相对于彼此的取向借助齿轮传动系统(通过使用与第一磁体齿轮1212以及第二磁体齿轮1214两者啮合的中心齿轮1210)被维持。在一个实施方式中，磁体1186中一者的北磁极与另一磁体1186的南磁极同步转动，在一整转中匹配时钟位置。该构造公知提供提高的例如向磁体338的转矩递送。专利号为8382756的美国专利以及申请号为13/172598的美国专利申请(两者都通过引用合并于此)中描述了可以用于调节髓内装置300的方法的实施例以及外部调节装置的实施方式或者本发明的其它实施方式。
磁性手柄1178的部件在磁板1190与前板1192之间被保持在一起。大部分部件被罩1216保护。磁体1186在静磁盖1188内旋转，从而磁性手柄1178可以在不向患者的外表面传递任何动作的情况下直接支托在患者上。在牵引髓内延长装置1110之前，操作者将磁性手柄1178放置在患者上靠近磁体338的位置。介于两个磁体1186之间的磁体支座1194包含视窗1196以辅助放置。例如，可以通过视窗1196观察用不可擦除的标记笔在患者的皮肤上的合适位置处做出的标记。为了进行牵引，操作者借助磁性手柄1178的把手1200保持磁性手柄1178并且按下牵引开关1228，使马达1202沿第一方向驱动。马达1202具有齿轮箱1206，该齿轮箱使输出齿轮1204的旋转速度不同于马达1202的旋转速度(例如，较低的速度)。然后，输出齿轮1204转动与中心齿轮1210啮合的减速齿轮1208，使该中心齿轮以不同于减速齿轮1208的旋转速度转动。中心齿轮1210与第一磁体齿轮1212以及第二磁体齿轮1214两者啮合，使它们均以相同的速率转动。取决于身体的供外部调节装置1180的磁体1186定位的部分，期望控制此速率以使由磁体1186以及磁体338传递的穿过身体的组织以及体液的合成感应电流密度最小化。例如，构想60RPM或者更小的磁体旋转速度，但是可以使用诸如35RPM或者更小的其它速度。在任何时候，可以通过按下缩进开关1230减轻牵引，可能在患者感觉保持装置的区域中非常疼痛或者麻木时期望如此。
在介绍的所有实施方式中，磁体338用作驱动元件以远程创建髓内装置300中的移动。图9至图12示意性示出了四个另选实施方式，其中，使用其它类型的能量传输代替永磁体。
图9示出了包括植入体1306的髓内装置1300，该植入体具有第一植入部分1302以及第二植入部分1304，第二植入部分1304可相对于第一植入部分1302非侵入地移位。第一植入部分1302固定至患者191内的第一骨部分197并且第二植入部分1304固定至第二骨部分199。马达1308可操作成使第一植入部分1302与第二植入部分1304相对于彼此移位。外部调节装置1310具有用于由操作者输入的控制面板1312，还具有显示器1314以及发送器1316。发送器1316将穿过患者191的皮肤195的控制信号1318发送至植入的接收器1320。植入的接收器1320经由导线1322与马达1308通讯。马达1308可以由可植入的电池提供动力，或者可以通过感应耦合提供动力或者充电。
图10示出了包括植入体1406的髓内装置1400，该植入体具有第一植入部分1402以及第二植入部分1404，第二植入部分1404可相对于第一植入部分1402非侵入地移位。第一植入部分1402固定至患者191内的第一骨部分197并且第二植入部分1304固定至第二骨部分199。超声马达1408可操作成使第一植入部分1402与第二植入部分1404相对于彼此移位(例如，压电致动器)。外部调节装置1410具有用于由操作者输入的控制面板1412，还具有显示器1414以及联接至患者191的皮肤195的超声换能器1416。超声换能器1416产生超声波1418，这些超声波穿过患者191的皮肤195的控制信号1318并且操作超声马达1408。
图11示出了包括植入体1706的髓内装置1700，该植入体具有第一植入部分1702以及第二植入部分1704，第二植入部分1704可相对于第一植入部分1702非侵入地移位。第一植入部分1702固定至患者191内的第一骨部分197并且第二植入部分1704固定至第二骨部分199。形状记忆致动器1708可操作成使第一植入部分1302与第二植入部分1304相对于彼此移位。外部调节装置1710具有用于由操作者输入的控制面板1712，还具有显示器1714以及发送器1716。发送器1716将穿过患者191的皮肤195的控制信号1718发送至植入的接收器1720。植入的接收器1720经由导线1722与形状记忆致动器1708通讯。形状记忆致动器1708可以由可植入的电池提供动力，或者可以通过感应耦合提供动力或者充电。
图12示出了包括植入体1806的髓内装置1800，该植入体具有第一植入部分1802以及第二植入部分1804，第二植入部分1804可相对于第一植入部分1802非侵入地移位。第一植入部分1802固定至患者191内的第一骨部分197并且第二植入部分1804固定至第二骨部分199。液压泵1808可操作成使第一植入部分1802与第二植入部分1804相对于彼此移位。外部调节装置1810具有用于由操作者输入的控制面板1812，还具有显示器1814以及发送器1816。发送器1816将穿过患者191的皮肤195的控制信号1818发送至植入的接收器1820。植入的接收器1820经由导线1822与液压泵1808通讯。液压泵1808可以由可植入的电池提供动力，或者可以通过感应耦合提供动力或者充电。液压泵1808可以另选被气压泵代替。
图13示出了不完整并缺失一部分的骨100。骨100包括近端部分102以及远端部分104。骨100具有近端106以及远端108，还具有在这两端之间延伸的骨髓管110。骨100可以代表若干不同的长骨，例如，股骨、胫骨、腓骨、肱骨或其它，或者甚至其它骨(例如，下颌骨)。近端部分102与远端部分104之间的开放区域112代表缺失骨。开放区域112可以由于若干原因中的任一原因而存在。例如，可能在创伤性事故过程中或者创伤性事故后的一次或者多次外科手术过程中失去骨100的该部分。或者，可能已经随生癌的骨的一部分(例如，由一类或者多类肉瘤引起的肿瘤)的切除一起被移除。
图14中，示出了附接至骨100的用于骨搬移的系统400。用于骨搬移的系统包括长度可调节的植入体401以及支撑构件403。在一些实施方式中，长度可调节的植入体401可以包括诸如图1至图8的髓内装置300或者图9至图12中所示的任一实施方式之类的髓内肢体延长装置。可调节的植入体401包括杆402，该杆可伸缩地从壳404移位。杆402可以借助驱动元件405被牵引出或者缩进到壳404中。在使用中，长度可调节的植入体401可以在骨髓管110被钻孔或者铰孔以移除材料或者以增大其内直径之后植入骨100的骨髓管110内。在植入长度可调节的植入体401之前或者随其后，可以通过切割、锯等制作截骨406以创建骨100的搬移部分114。在图14中，从骨100的远端部分104创建搬移部分114。在其它情况下，可以从骨100的近端部分102制作搬移部分114。在图14中，长度可调节的植入体401从骨100的近端106插入(即，以顺行的方式)。但是，在其它情况下，长度可调节的植入体401可以从远端108插入(即，以逆行的方式)。在搬移部分114由于截骨406与骨100的远端部分104分开的情况下，搬移部分114与近端部分102可以联接至长度可调节的植入体401以便使搬移部分114相对于近端部分102以及远端部分104移动。为了附接骨100的块，可以在经过位于壳404中的一个或者多个孔410的轴线上将骨100的近端部分102钻孔，并且穿过一个或者多个孔410放置一个或者多个骨螺钉408并将骨螺钉408固定至骨100的近端部分102。可以在经过位于杆402中的一个或者多个孔412的轴线上将骨100的搬移部分114钻孔，并且可以穿过一个或者多个孔412放置一个或者多个骨螺钉414并将骨螺钉414固定至骨100的搬移部分114。然后，可以使搬移部分114沿长度可调节的植入体401的纵轴线Z非侵入地移动。如图14中描绘的长度可调节的植入体401可以以充分或者基本上延伸的状态供应至使用者(杆402充分或者大致从壳404被牵引)，从而搬移过程使搬移部分114离开远端部分104并且朝着近端部分102移动。以此牵引的方式，搬移部分114被牵拉而不被推动。搬移部分114上的牵拉往往随搬移部分114移动而提供增大的尺寸稳定性以及更少的漂移。一旦在截骨406处开始合意地形成骨痂，就可以启动搬移过程。例如，搬移部分114可以在每天约0.5mm与每天约1.50mm之间或者每天约0.75mm与每天约1.25mm之间或者大约每天1.00mm地移动。每日牵引量可以在每天一次非侵入调节中完成，或者可以分成两次、三次或者更多次单独调节(例如，每次约0.33mm的三次调节)。由于在搬移部分114的受控搬移过程中会发生骨生成，新骨部分416被创建。当骨搬移行进至使搬移部分114的近端418到达近端部分102的远端420的程度时，可以向搬移部分114以及近端部分102施加压缩力。这样的压缩力可以帮助搬移部分114融合或者粘附至近端部分，并且得益于通过牵拉搬移部分114被施加的事实。
如以上提及的，用于骨搬移的系统400还可以包括支撑构件403，该支撑构件可以包括构造成固定至骨100的外表面422所在位置的骨板。骨板可以包括皮质骨板。支撑构件403可以包括位于其远端426处用于放置一个或者多个骨螺钉428的一个或者多个孔424。支撑构件403还可以包括位于其近端432处用于放置一个或者多个骨螺钉434、436的一个或者多个孔430。骨螺钉434、428可以是双皮质骨螺钉并且骨螺钉436可以是单皮质骨螺钉。双皮质骨螺钉可以有利地用在骨100上的靠近或者远离长度可调节的植入体401的位置处，而单皮质骨螺钉可以有利地用在骨100上邻近长度可调节的植入体401的位置处。用于将支撑构件403固定至骨100的骨螺钉428、434、436可以具有螺纹轴以及锥形螺纹头，螺纹轴与锥形螺纹头构造成使得螺纹轴与骨材料接合并且锥形螺纹头与支撑构件403中的锥形螺纹孔(例如，一个或者多个孔424、430)接合。支撑构件403使骨100的近端部分102以及远端部分104相对于彼此维持静止并且稳固，从而在搬移部分114关于近端部分102以及远端部分104移动时优化搬移部分114的移动的精确度。一个或者多个环扎429、431可以用于进一步将系统固定就位，例如用于进一步将支撑构件403固定至骨100。虽然图15中省略了环扎429、431，但是应理解它们可以与本文中公开的设备或者方法的任一实施方式一起使用。在一些实施方式中，支撑构件403可以包括相当多的用于放置骨螺钉的孔。例如，支撑构件403的构造成放置在股骨的近端处的部分可以具有三个、四个或者更多个用于放置骨螺钉的孔，这些骨螺钉构造成固定到骨中并且延伸到股骨颈、大转子或者股骨的包括一个或者多个骨节段的其它部分中。
图16与图17示出了固定至骨100的用于骨搬移的系统400。然而，长度可调节的植入体401从骨的远端108插入到骨髓管110中(即，以逆行方式)。因而在骨100的近端部分102中制作截骨406，并且从骨的近端部分102拆下搬移部分114。朝骨100的远端部分104将搬移部分114搬移离开骨100的近端部分102以创建新骨部分416。
可以在手术过程中通过以类似于图14的取向放置长度可调节的植入体401(例如，杆402向远端延伸或者朝下取向并且壳404向近端延伸或者朝上取向)，但是如图16中所示通过逆行插入(即，从骨100的远端108)而创建另选解剖设置。可以在手术过程中通过以类似于图16的取向放置长度可调节的植入体401(例如，杆402向近端延伸或者朝上取向并且壳404向远端延伸或者朝下取向)，但是如图14中所示通过顺行插入(即，从骨100的近端106)而创建再一另选解剖设置。
图20示出了用于骨搬移的系统500。用于骨搬移的系统包括长度可调节的植入体501以及支撑构件503(例如，板)。在一些实施方式中，长度可调节的植入体501可以包括诸如图1至图8的髓内装置300或者图9至图12的任一另选实施方式之类的髓内肢体延长装置。可调节的植入体501包括杆502，该杆可伸缩地从壳504移位。杆502可以借助驱动元件505被牵引出或者缩进到壳504中(图21至图22中所示)。在使用中，长度可调节的植入体501在骨髓管110被钻孔或者铰孔以移除材料或者以增大其内直径之后植入骨100的骨髓管110内。在这之前或者随其后，通过切割、锯等制作截骨406以创建骨100的搬移部分114。在图21中，从骨100的远端部分104创建搬移部分114。在其它情况下，可以从骨100的近端部分102制作搬移部分114。图21中示出了已经以顺行方式插入的长度可调节的植入体501。但是，在其它情况下，长度可调节的植入体501可以以逆行的方式插入。在搬移部分114(例如由于截骨406)与骨100的远端部分104分开后，搬移部分114与近端部分102可以联接至长度可调节的植入体501以便使搬移部分114相对于近端部分102以及远端部分104移动。可以在经过位于壳504中的一个或者多个孔510的轴线上将骨100的近端部分102钻孔，并且穿过一个或者多个孔510可以放置一个或者多个骨螺钉508并将骨螺钉508固定至骨100的近端部分102。可以在经过位于杆502中的一个或者多个孔512的轴线上将骨100的搬移部分114钻孔，并且可以穿过一个或者多个孔512放置一个或者多个骨螺钉514并将骨螺钉514固定至骨100的搬移部分114。然后，可以将搬移部分114沿长度可调节的植入体401的纵轴线Z非侵入地移动。如图21中描绘的长度可调节的植入体501可以以充分或者基本延伸的状态供应至使用者(杆502充分或者大致从壳504被牵引)，从而使得搬移过程使搬移部分114离开远端部分104并且朝着近端部分102移动。以此牵引的方式，搬移部分114被牵拉而不被推动。搬移部分114上的牵拉往往随搬移部分114移动而提供增大的尺寸稳定性以及更少的漂移。除支撑构件503包括在槽近端589与槽远端597之间延伸的纵向槽587以外，支撑构件503类似于图14至图17的支撑构件403。槽587位于支撑构件503的近端532与远端526之间。如图14至图17中所示的实施方式中，支撑构件503可以借助一个或者多个双皮质骨螺钉528、534(可以穿过孔524、530放置)以及一个或者多个单皮质骨螺钉536(穿过孔524、530放置)固定至骨100。如图20中所示，某些孔524a、524c可以偏移至支撑构件503的中线599的一侧，而其它孔524b可以偏移至支撑构件503的中线599的另一侧。在长度可调节的植入体501延伸至孔524a-c的水平面的情况下，以此方式偏移孔可以有助于放置双皮质骨螺钉。孔524a-c的偏移位置例如可以允许双皮质骨螺钉在杆502的两侧中的任一侧延伸越过杆502。骨100的搬移部分114可以通过沿孔512的轴线在搬移部分114的骨100中钻孔，以当固定骨螺钉514时这些骨螺钉从支撑构件503的槽587的外部位置593延伸穿过槽587并且延伸到搬移部分114的骨100中这样的方式而借助骨螺钉514固定至杆502。骨螺钉514以这样的方式对准：当杆502相对于壳504非侵入地平移时，骨螺钉514的轴597在槽587内滑动。如会容易理解的，骨螺钉514的轴597的直径小于槽587的宽度。在一些实施方式中，骨螺钉514的头的直径大于槽587的宽度，从而进一步稳固搬移部分114并且限制其沿x轴线移位的能力。转至图22，搬移部分114本身被支撑构件503限制，使得搬移部分114在正x方向上基本不平移(漂移)。搬移部分114也可以被骨螺钉514的头595限制，使得在搬移部分的纵向调节过程中或者静止时，搬移部分114在负x方向上基本不平移。
在骨搬移或者肢体延长过程中，搬移或者牵引长度会在过程与过程之间并且/或者患者与患者之间有很大程度的变更。在骨搬移过程中，搬移长度可能随着缺失骨的长度与手术过程中创建的搬移部分114的长度的变化而变化。长度可调节的植入体套件600(图23中所示)可以构造成允许使用者创建适合于待治疗的患者的特定搬移长度或者牵引长度的长度可调节的植入体(例如，图24的长度可调节的植入体601)。长度可调节的植入体套件600可以包括基部致动器605，该基部致动器包括壳604、基部杆602以及一个或者多个杆延伸部(例如，杆延伸部606、608、610)。基部杆602可以在壳604内可伸缩地移动(如本文中别处描述的)并且具有内螺纹部分612。各个杆延伸部606、608、610具有外螺纹部分614，该外螺纹部分构造成拧到基部杆602的内螺纹部分612中。使用者(例如，外科医师或者内科医师)可以针对特定患者选择合适的杆延伸部606、608、610。例如，如果需要相对长的搬移或者牵引长度则可以选择杆延伸部606，然而如果需要相对短的搬移或者牵引长度则可以选择杆延伸部610。要理解，杆延伸部606、608、610可以具体不同的特性(包括但不限于锚定孔616的数量、锚定孔616的轴向取向、锚定孔直径(例如，用于与不同直径的骨螺钉一起使用)等)。杆延伸部606、608、610可以包括中空部分。例如，内部通道618可以穿过杆延伸部610(或者任一其它杆延伸部606、608)的具有外螺纹部分614的端部。以此方式，例如，如果导螺杆(未示出)从基部杆602的内部延伸，则导螺杆可以延伸到内部通道618中。在一些实施方式中，导螺杆可以是可延伸的(即，可以具有这样的端部，该端部可以被导螺杆的延伸部增大)。内螺纹部分612与外螺纹部分614可以均具有结合有例如闩锁、卡扣、棘爪、钩的锁定特征或者具有摩擦配合特征，当杆延伸部606、608、610联接至基部杆602(例如，旋拧在一起)时，锁定特征或者摩擦配合特征将杆延伸部606、608、610以及基部杆602固定。在另选实施方式中，基部杆602可以包括外螺纹部分，并且杆延伸部606、608、610均可以包括内螺纹部分。图23至图24的长度可调节的植入体套件600可以用在标准肢体延伸过程中或者骨搬移过程中(包括但不限于本文中描述的那些)。通过可以在手术过程中利用长度可调节的植入体套件600，外科医师或者内科医师可以更容易选择并且/或者构建最适于正治疗的患者的装置。在一些实施方式中，杆延伸部606、608、610可以容易被灭菌(例如，蒸汽灭菌/高压锅、气体)，这可以降低过程的成本，当基部致动器605必须由供应商无菌供应时尤为如此。在使用中，外科医师或者内科医师(应理解成包括任何其它医疗技术人员，例如在外科医师或者内科医师管理或者指导下的那些医疗技术人员)可以附接一个杆延伸部，并且如果该杆延伸部不恰当配合患者则移除它并用另一个杆延伸部替换该杆延伸部。在另选实施方式以及方法中，支撑构件403、503可以被这样的外部固定器代替，该外部固定器包括：构造成定位在患者外部的基部；构造成一端附接至基部并且另一端联接至骨的第一部分的第一销；以及构造成一端附接至基部并且另一端联接至骨的第二部分的第二销。
虽然在一些优选实施方式以及实施例的背景下公开了本发明，但是本领域中的普通技术人员会理解本发明超出具体公开的实施方式延伸至本发明的另选实施方式以及/或者用途以及明显的变型例及其同等物。此外，虽然已经详细示出并且描述了本发明的若干变更例，但是在本公开的基础上本领域中的普通技术人员会容易理解在本发明的范围内的其它变型例。还构想，可以做出实施方式的具体特征以及方面的多种组合或者子组合并且这些组合或者子组合将落入本发明的范围内。因此，应理解，公开的实施方式的各种特征以及方面可以相互结合或者彼此替代以便形成公开的发明的不同模式。因此，本文中公开的本发明的范围理应不被以上描述的具体公开的实施方式限制，而应通过公正解读所附权利要求被确定。
类似地，不要将公开的此方法理解成体现这样的意图：任何权利要求需要比该权利要求中明确叙述的特征更多的特征。相反，如所附权利要求体现的，新颖性特征在于比前面公开的任何单个实施方式的所有特征更少的特征的组合。因此，具体实施方式之后的权利要求特此明确结合到此具体实施方式中，每项权利要求都独立作为单独的实施方式。

Claims (18)

1.一种骨搬移用的系统，该系统包括：
长度可调节的植入体，该长度可调节的植入体构造成用于髓内放置并且包括：
构造成联接至第一骨部分和第二骨部分中的一者的第一端以及构造成联接至搬移骨部分的第二端，其中，所述第一端与所述第二端能沿纵轴线相对于彼此移位；以及
驱动元件，该驱动元件构造成被非侵入地启用成使所述第一端与所述第二端沿所述纵轴线相对于彼此移位；以及
支撑构件，该支撑构件具有近端与远端，所述近端构造成联接至所述第一骨部分，所述远端构造成联接至所述第二骨部分，其中，所述支撑构件构造成保持所述第一骨部分相对于所述第二骨部分的位置，而所述长度可调节的植入体使所述搬移骨部分相对于所述第一骨部分和所述第二骨部分移位，其中，所述支撑构件包括布置在所述支撑构件的所述远端与所述近端之间的纵向延伸槽，所述槽具有相对的两端，并且其中，所述槽构造成供固定至所述搬移骨部分的细长锚穿过，使得当所述长度可调节的植入体的所述第一端和所述长度可调节的植入体的所述第二端沿所述纵轴线相对于彼此移位时，所述细长锚在所述槽的所述相对的两端之间滑动。
2.根据权利要求1所述的系统，其中，所述驱动元件包括永磁体。
3.根据权利要求2所述的系统，其中，所述永磁体包括径向极化稀土磁体。
4.根据权利要求2所述的系统，其中，所述驱动元件包括马达。
5.根据权利要求4所述的系统，其中，所述驱动元件包括感应耦合马达。
6.根据权利要求1所述的系统，其中，所述驱动元件包括超声致动马达。
7.根据权利要求1所述的系统，其中，所述驱动元件包括压电元件。
8.根据权利要求1所述的系统，其中，所述驱动元件包括皮下液压泵。
9.根据权利要求1所述的系统，其中，所述驱动元件包括形状记忆从动致动器。
10.根据权利要求1所述的系统，其中，所述支撑构件包括位于其远端与近端中的一者或者多者处的一个或者多个孔，所述一个或者多个孔均构造成穿过骨螺钉。
11.根据权利要求10所述的系统，其中，所述一个或者多个孔均具有阴螺纹，所述阴螺纹构造成接合骨螺钉的头带有的阳螺纹。
12.根据权利要求1所述的系统，其中，所述长度可调节的植入体构造成当所述驱动元件被非侵入地启用时，所述长度可调节的植入体的所述第一端与所述第二端之间的距离能受控地缩短。
13.根据权利要求1所述的系统，其中，所述长度可调节的植入体进一步包括壳以及牵引杆，该牵引杆构造成相对于所述壳能伸缩地移动。
14.根据权利要求1所述的系统，其中，所述长度可调节的植入体进一步包括壳以及带螺纹的基部，该带螺纹的基部构造成相对于所述壳能伸缩地移动。
15.根据权利要求14所述的系统，该系统进一步包括具有第一端以及第二端的杆，
所述第一端具有带螺纹的部分，该带螺纹的部分构造成用于固定至所述长度可调节的植入体的所述带螺纹的基部。
16.根据权利要求15所述的系统，其中，所述杆的所述第一端的所述带螺纹的部分包括外螺纹。
17.根据权利要求15所述的系统，其中，所述杆的所述第一端的所述带螺纹的部分包括内螺纹。
18.根据权利要求15所述的系统，其中，所述杆的所述第二端包括一个或者多个锚定孔，所述锚定孔构造成越过一个或者多个骨锚。
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