CN113425401A - 用于治疗膝关节炎的可调式装置 - Google Patents

用于治疗膝关节炎的可调式装置 Download PDF

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CN113425401A
CN113425401A CN202110751979.6A CN202110751979A CN113425401A CN 113425401 A CN113425401 A CN 113425401A CN 202110751979 A CN202110751979 A CN 202110751979A CN 113425401 A CN113425401 A CN 113425401A
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anchor
bone
inner shaft
tibia
anchor hole
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阿达姆·G·贝克特
托马斯·B·比福德
裵吏三
E·H·金
M·T·雅各布斯
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Nuvasive Specialized Orthopedics Inc
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Abstract

本发明涉及用于治疗膝关节炎的可调式装置。在一个实施方式中，用于改变对象的骨的角度的系统包括：无创可调式植入物，所述无创可调式植入物被配置成放置在所述骨的内部的纵向空腔内侧并且包括外壳和以可伸缩的方式布置在所述外壳中的内轴，所述外壳和内轴中的至少一者与第一锚孔和第二锚孔关联，所述第一锚孔被配置成供用于将所述可调式植入物联接到骨的第一部分的第一锚定器穿过并且所述第二锚孔被配置成供用于将所述可调式植入物联接到骨的所述第一部分的第二锚定器穿过，并且所述内轴被配置成联接到骨的从骨的所述第一部分分离或能够从所述第一部分分离的第二部分。

Description

用于治疗膝关节炎的可调式装置
本申请是国际申请日为2016年10月17日，申请号为201680059693.9(PCT/US2016/057371)，发明名称为“用于治疗膝关节炎的可调式装置”的专利申请的分案申请。
技术领域
本发明的领域总体涉及用于治疗膝骨关节炎的医疗装置。
背景技术
膝骨关节炎是影响大量患者(特别是40岁以上的患者)的膝关节退行性疾病。这种疾病的患病率在过去几十年来显著增加，部分归因于(但不完全是)人口的年龄上升以及肥胖的增加。这种增加也可能由于人口中高度活跃的人的增加。膝骨关节炎主要因关节上的长期应力引起，它使覆盖关节骨(包括股骨和胫骨二者)接合表面的软骨退化。时常地，该问题在创伤事件之后变得更糟，但也可能是遗传过程。症状可包括疼痛、僵硬、运动范围缩小、肿胀、畸形和肌肉无力，等。骨关节炎可能牵涉膝的三个隔室中的一个或更多个；胫股关节的内侧隔室、胫股关节的外侧隔室和/或髌股关节。在严重的情况下，可执行膝的部分或全部置换，以用通常由植入物级塑料或金属制成的新的负重表面置换患病部分。这些操作可能涉及显著的手术后疼痛并且一般需要大量的物理治疗。恢复期可能持续数周或数月。这种手术存在几种潜在的并发症，包括深静脉血栓症、运动丧失、感染和骨折。在恢复之后，接受部分或全部膝置换的手术患者必须显著减少其活动，消除高能量和冲击活动(包括跑步及许多其他运动)，完全摆脱其生活方式。
发明内容
在第一实施方式中，本公开提供了一种用于改变对象的骨的角度的系统，该系统包括：无创可调式植入物，所述无创可调式植入物被配置成放置在所述骨内的纵向空腔内侧并且包括外壳和可伸缩地布置在所述外壳中的内轴，所述外壳和内轴中的至少一者与第一锚孔和第二锚孔关联，所述第一锚孔被配置成供用于将所述可调式植入物联接到骨的第一部分的第一锚定器穿过并且所述第二锚孔被配置成供用于将所述可调式植入物联接到骨的所述第一部分的第二锚定器穿过，所述内轴被配置成联接到骨的从骨的所述第一部分分离或可分离的第二部分，使得所述可调式植入物的无创伸长会导致所述内轴从所述外壳延伸并且使骨的所述第一部分和骨的所述第二部分成角度地移开；驱动元件，所述驱动元件被配置成能远程操作以使所述内轴相对于所述外壳可伸缩地移位；并且其中，所述第一锚孔被配置成允许所述第一锚定器在至少第一角度方向上枢转，并且所述第二锚孔被配置成允许所述第二锚定器在至少第一平移方向上平移。
在第二实施方式中，本公开提供了一种用于改变对象的骨的角度的系统，该系统包括：无创可调式植入物，所述无创可调式植入物被配置成放置在所述骨内的纵向空腔内侧并且包括外壳和可伸缩地布置在所述外壳中的内轴，所述外壳和内轴中的至少一者与第一锚孔关联，所述第一锚孔被配置成供用于将所述可调式植入物联接到骨的第一部分的第一锚定器穿过，所述内轴被配置成联接到骨的从骨的所述第一部分分离或可分离的第二部分，使得所述可调式植入物的无创伸长会导致所述内轴从所述外壳延伸并且使骨的所述第一部分和骨的所述第二部分成角度地移开；以及驱动元件，所述驱动元件被配置成能远程操作以使所述内轴相对于所述外壳可伸缩地移位；其中，所述第一锚定器包括被配置成在槽内滑动并在骨的所述第一部分的第一侧处进入皮质骨的第一端部、被配置成在所述槽内滑动并在骨的所述第一部分的第二侧处进入皮质骨的第二端部以及被配置成驻留在所述第一锚孔内的居间部分。
在第三实施方式中，本公开提供了一种用于改变对象的骨的角度的系统，该系统包括：无创可调式植入物，所述无创可调式植入物被配置成放置在所述骨内的纵向空腔内侧并且包括外壳和可伸缩地布置在所述外壳中的内轴，所述外壳和内轴中的至少一者与第一锚孔关联，所述第一锚孔被配置成供用于将所述可调式植入物联接到骨的第一部分的第一锚定器穿过，其中所述第一锚孔被配置成允许所述第一锚定器在至少第一角度方向上枢转，所述内轴被配置成联接到骨的从骨的所述第一部分分离或可分离的第二部分，使得所述可调式植入物的无创伸长会导致所述内轴从所述外壳延伸并且使骨的所述第一部分和骨的所述第二部分成角度地移开；驱动元件，所述驱动元件被配置成能远程操作以使所述内轴相对于所述外壳可伸缩地移位；并且其中，所述外壳和内轴中的至少一者另外包括两个接合部分，所述两个接合部分被配置成能旋转地接合弯曲的锚定器。
在第四实施方式中，本公开提供了一种用于改变对象的骨的角度的系统，该系统包括：无创可调式植入物，所述无创可调式植入物被配置成放置在所述骨内的纵向空腔内侧并且包括外壳和可伸缩地布置在所述外壳中的内轴，所述外壳和内轴中的至少一者与第一锚孔关联，所述第一锚孔被配置成供用于将所述可调式植入物联接到骨的第一部分的第一锚定器穿过，其中所述第一锚孔被配置成允许所述第一锚定器在至少第一角度方向上枢转，所述内轴被配置成联接到骨的从骨的所述第一部分分离或可分离的第二部分；驱动元件，所述驱动元件被配置成使螺旋地联接到螺母的螺钉旋转，所述螺母包括末端部分，所述末端部分被配置成当所述第一锚定器位于所述第一锚孔内时接触所述第一锚定器上的部位，使得所述驱动元件的远程致动会导致所述螺钉旋转并使所述螺母纵向移位，由此导致所述第一锚定器在所述第一旋转方向上枢转。
在第五实施方式中，本公开提供了一种用于改变对象的骨的角度的系统，该系统包括：无创可调式植入物，所述无创可调式植入物被配置成放置在所述骨内的纵向空腔内侧并且包括外壳和可伸缩地布置在所述外壳中的内轴，所述无创可调式植入物的至少一个端部与第一锚孔关联，所述第一锚孔被配置成供用于将所述可调式植入物联接到骨的第一部分的第一锚定器穿过，所述内轴被配置成联接到骨的从骨的所述第一部分分离或可分离的第二部分，使得所述可调式植入物的无创伸长会导致所述内轴从所述外壳延伸并且使骨的所述第一部分和骨的所述第二部分成角度地移开；驱动元件，所述驱动元件被配置成能远程操作以使所述内轴相对于所述外壳可伸缩地移位；其中，所述无创可调式植入物的所述至少一个端部能旋转地联接到所述外壳或所述内轴中的至少一者。
附图说明
图1图示了膝关节的理想对准。
图2图示了错位的膝关节。
图3图示了胫骨中的开放楔形技术。
图4图示了插入有骨移植物且附接有板的开放楔形技术。
图5图示了无创可调式楔形截骨装置。
图6图示了沿着线6-6截取的图5的无创可调式楔形截骨装置的剖视图。
图7图示了图5的无创可调式楔形截骨装置的分解视图。
图8图示了外部调节装置。
图9图示了图8的外部调节装置的磁性手持件的分解视图。
图10至图12图示了无创可调式楔形截骨装置的另一实施方式的各种视图。
图13图示了图10至图12的无创可调式楔形截骨装置的端部。
图14图示了沿着线14-14截取的图13的无创可调式楔形截骨装置的剖视图。
图15图示了在胫骨内适当位置的无创可调式楔形截骨装置的正视图。
图16图示了在胫骨内适当位置的无创可调式楔形截骨装置的侧视图。
图17图示了在胫骨内适当位置的无创可调式楔形截骨装置的俯视图。
图18图示了胫骨内处于基本未调节状态下的无创可调式楔形截骨装置。
图19图示了胫骨内处于第一调节状态下的无创可调式楔形截骨装置。
图20图示了胫骨内处于第二调节状态下的无创可调式楔形截骨装置。
图21图示了在移除无创可调式楔形截骨装置之后的巩固胫骨。
图22图示了无创可调式楔形截骨装置的开槽横向孔内的骨螺钉。
图23至图25图示了无创可调式楔形截骨装置的另一实施方式的各种视图。
图26图示了胫骨内处于基本未调节状态下的图23的无创可调式楔形截骨装置。
图27至图29图示了胫骨内处于各种调节状态下的图23的无创可调式楔形截骨装置。
图30图示了用于膝关节对准的标准矫正。
图31图示了用于膝关节对准的计划过矫。
图32图示了胫骨内相对于标准矫正轴线和计划过矫轴线的无创可调式楔形截骨装置。
图33至图34图示了锚定器处于各种位置中的无创可调式楔形截骨装置的锥形或沙漏形锚孔。
图35至图37图示了具有处于各种位置中的偏心轴承的无创可调式楔形截骨装置。
图38至图39图示了膝关节及植入到胫骨中处于各种牵引状态下的无创可调式楔形截骨装置。
图40图示了图38的无创可调式楔形截骨装置的一个实施方式的内螺纹锚孔。
图41图示了植入有无创可调式楔形截骨装置的一个实施方式的胫骨的正视图。
图42图示了图41的胫骨的俯视图。
图43至图44图示了植入有处于各种牵引状态下的无创可调式楔形截骨装置的另一实施方式的胫骨的正视图。
图45至图46图示了植入有处于各种牵引状态下的无创可调式楔形截骨装置的另一实施方式的胫骨的正视图。
图47至图50示意性地图示了无创可调式楔形截骨装置的驱动元件的各种实施方式。
图51图示了无创可调式楔形截骨装置的一个实施方式的侧视图。
图52图示了图51的无创可调式楔形截骨装置的剖视图。
图53图示了图51和图52的无创可调式楔形截骨装置的又一视图。
具体实施方式
鉴于部分和/或全部的膝置换手术的后果，对患者关节炎的进展进行早期干预可能是有利的。在这样的情况下，膝置换手术可能延迟或甚至排除。可在股骨或胫骨上执行截骨手术以改变股骨和胫骨之间的角度，从而调节膝关节不同部分上的应力。在已闭合楔形或闭合楔形截骨术中，倾斜的骨楔形可被移除并且其余表面融合在一起以产生新的改进的骨角度。在开放楔形截骨术中，切口可在骨中制成并且切口的边缘开口以产生新的角度。骨移植材料可有利地用于填充到新开口的楔形空间中，并且板可用骨螺钉附接至骨以提供附加结构支撑。然而，如上所述，在已闭合楔形或开放楔形截骨术中的任一者期间获得期望或正确的角度几乎总是次优的。此外，即使所得到的角度近似于期望的角度，也可能随后丢失矫正角度。使用这些技术时可能遇到的其他潜在的并发症，包括骨不连合和材料失效。
图1图示了股骨100、胫骨102和膝关节104的正确/健康对准。在这样的正确对准过程中，髋关节(在股骨头108处)、膝关节104和踝关节(在远侧胫骨110的中线处)总体沿着单个线112(被称为机械轴线)布置。在胫骨102旁边示出了腓骨106。通过与图1的膝关节104对比，图2的膝关节104被视为处于关节炎状态，其中膝的内侧隔室114(内侧意指位于中间或中心之中或者朝向中间或中心布置)已被损害，导致线112向内侧偏离膝关节104的中心。
图3图示了通过沿着切割线120进行切割并且张开楔形角度α而形成的开放楔形截骨118。图4图示了通过将骨移植材料122放置在开放楔形截骨118内然后放置板124来最终设定该开放楔形，板124然后用胫骨螺钉126固定到胫骨102。楔形角度α的增加也可以描述为远离内翻和/或移向外翻。
图5至图7图示了包括可磁调节的致动器342并具有第一端326和第二端328的无创可调式楔形截骨装置300。具有空腔374的内轴332可伸缩地联接到包括牵引壳体312和齿轮壳体306的外壳330或位于外壳330内。至少一个近侧横向孔305穿过位于可磁调节的致动器342的第一端326处的端盖302。至少一个近侧横向孔305允许骨螺钉或其他固定装置从中穿过，以将可调式楔形截骨装置300固定到其所植入的骨(例如，胫骨102)中。端盖302可由周向焊接关节390能密封地固定到齿轮壳体306。在一些实施方式中，端盖302可通过任何适当的固定方法(诸如摩擦、胶合、环氧树脂或任何类型的焊接)固定到齿轮壳体306。在其他实施方式中，端盖302和齿轮壳体306可单体地或一体地形成。第二焊接关节392将牵引壳体312能密封地固定到齿轮壳体306。在一些实施方式中，牵引壳体312可通过任何适当的固定方法(诸如摩擦、胶合、环氧树脂或任何类型的焊接)固定到齿轮壳体306。在其他实施方式中，牵引壳体312和齿轮壳体306可单体地或一体地形成。一个或更多个远侧横向孔364贯穿内轴332。一个或更多个远侧横向孔364允许骨螺钉或其他固定装置从中穿过，以将可调式楔形截骨装置300固定到其所植入的骨(例如，胫骨102)中。例如，一个或更多个远侧横向孔364和至少一个近侧横向孔305允许至少一个锁定螺钉穿过。一些实施方式仅使用一个远侧横向孔364和一个近侧横向孔305，以便在调节可磁调节的致动器342时更好地允许可磁调节的致动器342和锁定螺钉之间的旋转游隙。
在一些实施方式中，内轴332的外表面中的一个或更多个纵向凹槽372与防旋转环373的突起375(图7中示出)接合，以有利地最小化或抑制内轴332和牵引壳体312之间的旋转运动。防旋转环还在防旋转环373的平坦边缘384处接合牵引壳体312端部内的切口333。防旋转环373中的一个或更多个导向翅片383可以保持防旋转环373在牵引壳体312中的切口391内旋转地静止。
可磁调节的致动器342的内容物可有利地被保护以免受到体液的影响。在一些实施方式中，可磁调节的致动器342的内容物由可驻留在内轴332和牵引壳体312之间的一个或更多个O形环334与主体密封。例如，内轴332的外表面中的一个或更多个周向凹槽382用于沿着牵引壳体312的内表面动态地密封。例如，通过由径向极化的柱形磁体368转动的导螺杆348，内轴332可相对于外壳330轴向地延伸/缩回。径向极化的柱形磁体368被结合到磁体壳体308的第一部分和磁体壳体310的第二部分内并且由销336和径向轴承378(直接接合端盖302的埋头孔304(图7中示出))能旋转地保持在一端上。第二磁体壳体310连接或联接到行星齿轮系统370的第一级367。
在一些实施方式中，行星齿轮系统370可具有一级、两级、三级、四级或甚至五级。在其他实施方式中，根据需要，可包括超过五级。图6中示出的行星齿轮系统370的实施方式具有三级。不管装置中包括多少级，它们一般都可根据下面提供的描述来工作。三个行星齿轮系统370的行星齿轮387在齿轮壳体306(图7中示出)内的内齿321内转动。第一级367输出到第二级369，并且第二级369输出到第三级371。最后一级或第三级371联接到导螺杆348。在一些实施方式中，通过允许第三级371和导螺杆348之间一定程度的轴向游隙的联接件，例如，通过使第三级371的输出端和导螺杆348二者中的孔352的锁定销385通过，将最后一级或第三级371联接到导螺杆348。另选地，第三级371可直接输出到导螺杆348。导螺杆348与结合到内轴332的空腔374内的螺母376螺旋地接合。行星齿轮系统370的每一级均包含传动比。在一些实施方式中，传动比可以是2:1、3:1、4:1、5:1或6:1。在其他实施方式中，如果有必要，传动比可甚至高于6:1。由行星齿轮系统产生的总传动比等于升高到级数的传动比的每一侧。例如，传动比为4:1的三级(3级)系统(诸如图6中示出)最终传动比为4*4*4:1*1*1，或64:1。64:1的传动比意味着径向极化的柱形磁体368的64次转动引起导螺杆348的单次转动。以相同的方式，传动比为3:1的两级(2级)系统最终传动比为3*3:1*1，或9:1。在一些实施方式中，行星齿轮系统370包括具有不同传动比的级。例如，三级行星齿轮系统370可以包括传动比为4:1的第一级、传动比为3:1的第二级以及传动比为2:1的第三级，该系统的最终传动比为4*3*2:1*1*1，或24:1。可理想地包括壳体中的结构特征，用以吸收径向极化的柱形磁体和/或行星齿轮系统370上的轴向负载。
在一些实施方式中，一个或更多个推力轴承可用于吸收轴向负载。例如，推力轴承380可在轴向方向上松弛地保持在齿轮壳体306中的凸缘之间。推力轴承380被保持在齿轮壳体306中的凸缘393和齿轮壳体306端部处的插入件395之间。推力轴承380有利地保护径向极化的柱形磁体368、行星齿轮系统370、磁体壳体308和310以及径向轴承378免受不可接受的高压缩力。
在一些实施方式中，导螺杆联接器339可由穿过孔359的销385保持到导螺杆348。导螺杆联接器339可包括凸缘355，凸缘355类似于位于导螺杆348的基部处的对置凸缘(未示出)。在这些实施方式中，当内轴332缩回到最小长度时，导螺杆348的基部处的凸缘抵接导螺杆联接器的凸缘355，有利地防止导螺杆348因扭矩太高而卡在螺母上。
维护构件346或磁力制动器(包括磁性材料)可被包括(例如，结合)在齿轮壳体306内、邻近径向极化的柱形磁体368。在这样的实施方式中，维护构件346可以吸引径向极化的柱形磁体368的磁极以最小化径向极化的柱形磁体368的无意旋转(例如，当未被外部调节装置1180调节时转动，诸如在正常患者移动或活动期间)。维护构件346可有利地在径向极化的柱形磁体368上施加比外部调节装置1180更小的磁力。如此，维护构件保持径向极化的柱形磁体368在大部分时间基本上旋转地固定(例如，当牵引/缩回期间未被调节时)。但是，当使用外部调节装置1180时，外部调节装置1180的较强的力克服由维护构件346所生成的力并使径向极化的柱形磁体368转动。在一些实施方式中，维护构件346是“400系列”不锈钢。在其他实施方式中，维护构件346可以是任何其他适当的导磁材料。
无创可调式楔形截骨装置300具有分别通过将内轴332延伸出牵引壳体312以及将内轴332缩回到牵引壳体312中而增加或减小其长度的能力。无创可调式楔形截骨装置300具有如定义为完全伸出时的长度和完全缩回时的长度之差的行程长度。在一些实施方式中，可调式楔形截骨装置300的行程长度小于约30mm，小于约24mm，小于约18mm，小于约12mm，以及小于约6mm。在其他实施方式中，无创可调式楔形截骨装置300的行程长度大于30mm或者具有临床意义的任何其他行程长度。无创可调式楔形截骨装置300和外部调节装置1180的磁性手持件1178(导致径向极化的柱形磁体368旋转)之间的相互作用导致内轴332缩回(取决于磁体旋转方向)到牵引壳体312中，从而产生压缩力；或者导致内轴332延伸(取决于磁体旋转方向)出牵引壳体。可以由无创可调式楔形截骨装置300产生的力由多种因素确定，包括：径向极化的柱形磁体368的大小、维护构件346的大小、由外部调节装置1180产生的磁力(由磁性手持件1178的磁体大小确定)、磁性手持件1178和径向极化的柱形磁体368之间的距离、齿轮级数、每个齿轮级的传动比、无创可调式楔形截骨装置300内的内部摩擦损失，等。在一些实施方式中，临床设定中的(即，植入到普通患者中的)无创可调式楔形截骨装置300能够生成高达约300磅、高达约240磅、高达约180磅以及高达约120磅或具有临床意义或必要的任何其他力。在一些实施方式中，外部调节装置1180的磁性手持件1178被放置成使得其磁体1186距径向极化的柱形磁体368约二分之一英寸，可以实现约240磅的牵引力。
无创可调式楔形截骨装置的许多部件可由钛、钛合金(例如，钛-6Al-4V)、钴铬合金、不锈钢或其他合金制成。无创可调式楔形截骨装置300的直径由患者胫骨102中的髓管130的大小决定。虽然髓管130可通过扩孔或任何其他适当的技术扩大，但是一般理想地选择直径近似等于或略小于髓管130的直径的无创可调式楔形截骨装置300。在一些实施方式中，无创可调式楔形截骨装置300的直径小于约16mm，小于约14mm，小于约12mm，小于约10mm，小于约8mm，或者小于约6mm。在一些实施方式中，可使用对于给定患者具有临床意义的任何其他直径。
无创可调式楔形截骨装置300可用手插入或者可附接至插入工具(例如钻引导件)。在一些实施方式中，包括内螺纹397的接口366位于端盖302中以与插入工具的阳螺纹可逆地接合。另选地，这样的接合特征可位于内轴332的端部360上。在其他实施方式中，系绳(例如，可拆卸的系绳)可附接至无创可调式楔形截骨装置300的任一端，使得它可在放置不正确的情况下容易移除。
图8图示了外部调节装置1180的一个实施方式，其用于无创地调节本文中描述的装置和系统。如图8所示，外部调节装置1180可包括磁性手持件1178、控制箱1176和电源1174。控制箱1176可包括控制面板1182，控制面板1182具有一个或更多个控制器(按钮、开关或触觉反馈机构(即，可以使用包括例如热量、振动、纹理变化等触觉感测的任何反馈机构)、运动、音频或光传感器)和显示器1184。显示器1184可以是视觉、听觉、触觉等或前述特征的一些组合。外部调节装置1180可包含允许医师输入的软件。
图9示出了外部调节装置1180的磁性手持件1178的一个实施方式的细节。磁性手持件1178可包括多个磁体1186，包括6个磁体、5个磁体、4个磁体、3个磁体或2个磁体。在一些实施方式中，磁性手持件1178可仅具有单个磁体。磁体1186可具有多种形状中的任何形状，包括例如卵形、柱形等。图9图示了包括两个(2个)柱形磁体1186的磁性手持件1178。磁体1186可以是稀土磁体(诸如钕-铁-硼)，并且可以在一些实施方式中被径向极化。在一些实施方式中，磁体1186具有2个磁极、4个磁极或6个磁极。在其他实施方式中，磁体1186具有超过6个磁极。磁体1186可结合或以其他方式固定到磁性杯1187内。磁性杯1187均包括轴1198，轴1198附接至第一磁体齿轮1212和第二磁体齿轮1214。两个磁体1186中每者的磁极取向可大致相对于彼此固定。例如，磁极可使用传动系统旋转地锁定到彼此，传动系统可包括与第一磁体齿轮1212和第二磁体齿轮1214二者啮合的中心齿轮1210。在一些实施方式中，在整个旋转过程中的匹配时钟位置处，磁体1186之一的北磁极与另一个磁体1186的南磁极同步转动。此配置例如为径向极化的柱形磁体368提供了改进的扭矩输送。可用于调节本文中公开的各种无创可调式楔形截骨装置的各种外部调节装置的示例在美国专利号8,382,756和美国专利申请系列号13/172,598中进行了描述，其全部内容通过引用并入本文中。
磁性手持件1178的部件可在磁体板1190和前板1192之间被保持到一起。磁性手持件1178的部件可由盖1216保护。磁体1186在静止的磁体盖1188内旋转，使得磁性手持件1178可直接搁置在患者上而不会将任何运动传递到患者的外表面(例如，摩擦或牵拉患者的皮肤)。在使用(诸如启动无创可调式医疗装置)之前，操作者在径向极化的柱形磁体368的植入部位附近将磁性手持件1178放置到患者上。在一些实施方式中，插置在两个磁体1186之间的磁体支架1194包含观察窗口1196，以帮助将磁性手持件1178放置到患者上。例如，在适当的部位处在患者皮肤上做出的标记可透过观察窗口1196看到并且用于对准磁性手持件1178。为了执行牵引，操作者可用其手柄1200保持磁性手持件1178并按压牵引开关1228，从而导致马达1202在第一旋转方向上驱动。马达1202可具有变速箱1206，变速箱1206导致输出齿轮1204的转速不同于马达1202的转速(例如，速度更慢或速度更快)。在一些实施方式中，变速箱1206导致输出齿轮1204的转速与马达的转速相同。然后，输出齿轮1204使与中心齿轮1210啮合的减速齿轮1208转动，导致其以与减速齿轮1208不同的转速转动。中心齿轮1210与第一磁体齿轮1212和第二磁体齿轮1214二者啮合，使二者以相同的速率转动。取决于磁性手持件1178的磁体1186所在的身体部位，可期望控制磁体1186的旋转速率，以最小化经由身体的组织和流体由磁体1186和径向极化的柱形磁体368传递的感应电流密度。例如，设想了60转/分钟(“RPM”)以下的磁体转速，但是可使用其他速度，诸如35RPM以下。在任何时候，可通过按压缩回开关1230来减轻牵引，如果患者感觉到显著的疼痛或者已植入无创可调式装置的区域中的麻木，则可能是理想的。
图10至图12图示了配置成使楔形角度α的潜在增加量最大化的无创可调式楔形截骨装置400。如相对于其他实施方式(例如，无创可调式楔形截骨装置300)说明的，内轴432被配置成从外壳430可伸缩地移位，使得无创可调式楔形截骨装置400的长度可增加或减小。无创可调式楔形截骨装置400的内部部件可如关于本文中公开的无创可调式楔形截骨装置的其他实施方式所描述的那样进行配置。内轴432可以包括使骨锚定器或螺钉可以从中穿过以锚定装置的一个或更多个横向孔。这样的横向孔可相对于竖直成任何角度，并且可相对于水平成任何角度。期望地，当存在超过一个横向孔时，这些孔理想地不应该相交。在一些实施方式中，内轴432包括用于放置骨螺钉的三个横向孔464A、464B和464C。在一些实施方式中，横向孔464B相对于近似平行于彼此的横向孔464A和464C中的每者大致成90°角度。如同内轴432，外壳430可以包括使骨锚定器或螺钉可以从中穿过以锚定装置的一个或更多个横向孔。在一些实施方式中，外壳430包括第一横向孔405和开槽的第二横向孔407。第一横向孔405可相对于开槽的第二横向孔407大致成90°角度。在一些实施方式中，第一横向孔405被配置成当将无创可调式楔形截骨装置400放置到胫骨102内时在大致从外向内的方向上延伸(外侧意指位于一个或多个侧面中或者朝向一个或多个侧面布置)。在一些实施方式中，开槽的第二横向孔407被配置成当将无创可调式楔形截骨装置400放置到胫骨102内时在大致从前向后的方向上延伸。
开槽横向孔407大致延伸穿过无创可调式楔形截骨装置400的两个壁441、443和中心空腔445(图13至图14中示出)。开槽横向孔407可具有大致长方形形状，具有长度“L”和宽度“W”。宽度W可被配置成仅仅略大于用于将无创可调式楔形截骨装置400固定到骨的骨螺钉，使得骨螺钉能够穿过开槽横向孔407。长度L可被选择成使得骨螺钉能够在开槽横向孔407内枢转或者成角度地移位，直到在平面(例如，基本上取向为冠状平面的平面)内达到期望最大成角。在一些实施方式中，长度L与宽度W之比(L/W)总是大于一(1)，但小于约3、约2.5、约2、约1.5或约1.2。举例来说，当开槽横向孔407被配置成接收5mm骨螺钉时，宽度W可以是约5.05mm-5.25mm、约5.1mm-5.2mm或约5.15mm，并且长度L可以是约6mm-15mm、约7.5mm-12.5mm或者约8mm-10mm。图14还图示了具有内螺纹497的接口466，其可用于能释放地拆卸插入工具。
在图51至图53图示的另一实施方式中，无创可调式楔形截骨装置2002的一个或更多个横向孔2000可具有凸起部分2004，基本居中地位于横向孔2000内，骨锚定器或螺钉2006可以从中穿过以锚定装置。在一个实施方式中，凸起部分2004大致垂直于横向孔2000的纵向轴线延伸，使得横向孔的下表面在每个方向上从凸起部分到外部的斜率减小。凸起部分2002允许骨锚定器或螺钉2006枢转，从而为骨锚定器或螺钉2006提供(如图53中的箭头所示)更大的成角。凸起部分2004可以是圆形的或者可到达一个或更多个横向孔2000内的离散点。在该实施方式中，骨锚定器或螺钉2006可具有从第一位置到第二位置高达约40度的移动，更具体地可具有从第一位置到第二位置约20度的移动。凸起部分2002可提供的额外优点在于，它在围绕单个点而不是两个或更多个点枢转的同时允许骨锚定器或螺钉2006实现其全范围成角。
图15至图17示出了植入具有髓管130的胫骨102内的无创可调式楔形截骨装置400。例如由一系列钻头或铰刀沿着髓管130的一部分长度钻出孔132。可呈现单个切口或一系列切口(例如，楔形)的截骨118在胫骨102中制成，以将胫骨102分成第一部分119和第二部分121。在一些情况下，可制出钻孔452，然后使用刀片制造截骨118的切口，一直到钻孔452的点。由此，铰链450产生在胫骨102的未切割部分处。另选地，截骨118可完全穿过胫骨102(未示出这样的截骨)，并且铰链状装置可固定到胫骨102的外侧，邻近截骨。铰链状装置可包括或类似于由加拿大魁北克省Laval的Pega Medical销售的Hinge PediatricPlating SystemTM。在该另选方法中，可以从外侧而非内侧制造切口和截骨，留下内侧无切口。
返回图15至图17的配置，诸如图10至图14所示的无创可调式楔形截骨装置被插入到孔132中并且用骨螺钉(例如，两个或更多个骨螺钉134、136、138、140、142)固定到胫骨102。在诸如图15至图17所示的一些实施方式中，用经由第一横向孔405输送的第一骨螺钉134和经由开槽横向孔407输送的第二骨螺钉136将外壳430固定到胫骨102的第一部分119。用分别经由三个横向孔464A、464B、464C输送的三个骨螺钉138、140、142将内轴432固定到胫骨102的第二部分121。如描述的，开槽横向孔407可被配置成允许第二骨螺钉136在一定的角度范围内枢转或摆动，这将相对于图18至图22进一步描述。如图15至图17所示，第一骨螺钉134可沿着前后轴线(即，从前到后)被大致对准，并且第二骨螺钉136可沿着内外轴线(即，从一侧到另一侧)被大致对准，而在这两种情况下，也设想了其他成角度数。无创可调式楔形截骨装置400被配置成无创牵引胫骨102的第一部分119远离胫骨102的第二部分121，以成角度地张开截骨118。利用图17所示的第一骨螺钉134和第二骨螺钉136的取向，第一骨螺钉134可在孔405(图16)内自由旋转，并且第二骨螺钉136可在开槽横向孔407(图15至图16)内枢转。
图22演示了骨螺钉在开槽横向孔内的适当位置(例如，第二骨螺钉136在开槽横向孔407内)的可枢转性。骨螺钉可在任一方向(+β、-β)上枢转通过枢转角度β。图18至图20演示了调节植入到胫骨102中的无创可调式楔形截骨装置400以增大楔形截骨118的角度A。在图18中，内轴432从外壳430延长初始长度D1。截骨118处于初始闭合状态或大部分闭合状态下，并且第一骨螺钉136已被固定到胫骨102的第一部分119，使得第一骨螺钉136在相对于开槽横向孔407的第一角度方向上在第一枢转末端处、在第一枢转末端附近或者朝向第一枢转末端倾斜。更具体地，第一部分119的内侧上的第一骨螺钉136的头部144与第一部分119的外侧上的远端148相比处于较低的高度，使第一骨螺钉保持角度-β(参见图22)。虽然图18至图20中示出的骨螺钉具有较短的近侧阳螺纹146，但是可使用包括例如方头螺钉或全螺纹螺钉的其他骨螺钉。在图19中，已执行无创可调式楔形截骨装置400的牵引，导致内轴432从外壳430延伸使得内轴432延长新的长度D2，新的长度D2大于初始长度D1。在一些实施方式中，无创牵引的完成可通过：将外部调节装置1180的磁性手持件1178放置在上胫骨102区域中的皮肤或衣服上，以及操作外部调节装置1180以使一个或更多个磁体1186旋转，这又导致无创可调式楔形截骨装置400内的径向极化的永磁体368(图6至图7)磁旋转。内轴432伸出外壳430会导致第一部分119被抬离第二部分121，从而使截骨118张开到楔形角度A2。随着截骨118被张开，固定到胫骨102的第一部分119的第一骨螺钉136可随第一部分119一起旋转(开槽横向孔407允许/促进这种旋转)。在图19中，示出的第一骨螺钉136具有大致水平取向(即，β≈0°)。在图20中，执行额外牵引(例如，无创牵引)，并且内轴432从外壳430延长得更远使得内轴432延长新的增加的长度D3。截骨的新的增加的楔形角度A3源于内轴432的额外延长，并且第一骨螺钉136随胫骨102的第一部分119的继续旋转而一起枢转，直到第一骨螺钉136在相对于开槽横向孔407的第二角度方向上在第二枢转末端处、在第二枢转末端附近或者朝向第二枢转末端倾斜。更具体地，第一部分119的内侧上的第一骨螺钉136的头部144与第一部分119的外侧上的远端148相比处于较高的高度，使第一骨螺钉保持角度+β(参见图22)。
在患者清醒、移动和/或负重时进行无创牵引可允许实现最佳楔形角度A。在一些实施方式中，最佳楔形角度是患者感觉不到疼痛的楔形角度A。在其他实施方式中，最佳楔形角度是患者感觉不到接触膝关节处(例如膝关节的内侧隔室处)的组织的楔形角度A。在一些情况下，楔形角度A可增加直到达到解剖学基准(例如Fujisawa过矫)，这在下面进一步描述。牵引可在特定的时间间隔内完成。例如，如本文中公开的无创可调式楔形截骨装置的总长度可每天增加约0.5mm-1.5mm，或约0.75mm-1.25mm，或任何其他临床有利的速率，直到达到期望的楔形角度。另选地，如本文中公开的无创可调式楔形截骨装置的延长量可在每次调节过程(例如，延长、牵引或调节)之前计算，使得一致的楔形角度增加(即，使用三角关系使得角度可以增加一致的△β)通过每次调节过程来实现。在一些情况下，任何给定的每天调节都可在单次过程内同时进行。另选地，任何给定的每天调节可被分解成每天两个或更多个较小调节或过程(相当于每天期望的总量)。将调节分解成较小的过程可有利地帮助最小化因膝关节104中的软组织拉伸而引起的疼痛或不适。对于一些患者或者在一些情况下，可理想地基于内侧皮质增加速率(胫骨102的内侧边缘处的截骨118的张开部分)来确定期望的装置牵引速率。例如，可理想地以足够导致内侧皮质每天增加约1mm的速率来牵引装置：除其他因素外，取决于胫骨102的宽度，这种内侧皮质每天增加1mm可能仅需要每天装置牵引约0.5mm到0.65mm(即，在中线处每天增加)。在一些情况下，一旦达到最终期望的楔形角度，则停止牵引，并且允许楔形截骨118在一段时间内(例如；几天、几周或几个月)巩固。巩固所需的时间量可取决于楔形截骨118增加的角度、楔形截骨增加的速率、患者是否吸烟、患者是否有糖尿病以及患者的活动水平及其他生物因素。在牵引过程期间(例如，从植入到实质愈合)，患者可理想地例如通过使用拐杖、支架、轮椅、扶车等在被治疗的腿上放置减少(即，少于正常)量的力(压缩)。另外，可指导患者增加在巩固阶段中放置在腿上的负载：巩固期间的压缩与改善骨生成和更快更好的骨愈合正相关。
在一些情况下，在基本完成巩固阶段之后，可移除本文中公开的装置，包括无创可调式楔形截骨装置400和骨螺钉134、136、138、140、142。图21示出了在移除如本文中公开的无创可调式楔形截骨装置之后的修正的胫骨102。在牵引阶段和/或巩固阶段中，骨移植物可添加到楔形截骨118的部分，以便帮助增加胫骨102例如在第一部分119和第二部分121之间的固化。
图30示出了通过生产楔形截骨、例如通过使用标准方法或者本文中描述的设备和/或方法而调节的胫骨102的机械轴线112。机械轴线从股骨头108延伸，穿过膝关节104的中心，并到达远侧胫骨110处的踝关节的中心点。虽然穿过膝关节104的中心恢复机械轴线112在一些中心已成为标准实践，但是Fujisawa提出了另选方法(参见Fujisawa等人，“TheEffect of High Tibial Osteotomy on Osteoarthritis of the Knee:An ArthroscopicStudy of 54Knee Joints”，1979年7月，北美骨科诊所，第10卷、第3期、第585-608页，其全部内容通过引用并入本文中)。Fujisawa阐述了“理想的矫正方法是对准机械轴线以穿过中点外侧30％到40％的点”(Fujisawa等人，第606-607页)。如Fujisawa教导的过矫轴线150示出在图30至图31中并且在膝关节104中点外侧约30％-40％的点处穿过膝关节104。随着标准机械轴线穿过膝关节104的中点，过矫轴线150在标准机械轴线112外侧占大约相同的百分比。图31示出了由胫骨102的楔形截骨执行的过矫，该过矫近似达到Fujisawa所描述的条件。过矫的机械轴线152接近穿过膝关节104的过矫轴线150，从股骨头108的中心延伸穿过近似过矫轴线150处的膝关节，并到达远侧胫骨110处的踝关节的中心点。为了实现过矫，楔形截骨118的角度已增加额外的量。
图32图示了在胫骨102内的适当位置的无创可调式楔形截骨装置(例如无创可调式楔形截骨装置400)的一个实施方式，其中标示了标准机械轴线112和过矫轴线150。示出的过矫轴线150在外侧距标准机械轴线为距离x。在一些实施方式中，距离x介于从中线到外侧末端的总距离的约24％-44％、约28％-40％、约30％-38％和约32-36％。在图32中，执行中线矫正角度(“AMC”)以便实现示出的机械轴线112。AMC被定义为穿过膝关节104的中心来放置机械轴线所需的矫正角度的量，在许多患者中可高达约12°以下，并且可通过使用如本文中公开的无创可调式楔形截骨装置来实现。在一些情况下，需要大于12°的角度来实现如上所述的合适的过矫(例如，在一些患者中可理想地实现高达约16°以上的角度)。由此，可能需要附加过矫角度(“AOC”)以便产生如图31中的过矫的机械轴线152。在一些情况下，AOC可介于约1°至8°、约2°至7°、约3°至6°和约4°至5°，或者AOC可能是在生理学上对患者有益的任何其他角度。因此，所得到的总矫正角度等于角度AMC和AOC之和。
图23至图25中图示的无创可调式楔形截骨装置500的另一实施方式可被配置成允许增加胫骨102的角度矫正量。无创可调式楔形截骨装置500包括内轴532，内轴532能从外壳530可伸缩地牵引。在一些实施方式中，无创可调式楔形截骨装置500的内部部件可与本文中公开的其他无创可调式楔形截骨装置(例如图5至图6的无创可调式楔形截骨装置300，等)类似或相同。在一些实施方式中，开槽横向孔507延伸穿过无创可调式楔形截骨装置500的外壳530。开槽横向孔507具有大致长方形形状；类似于关于图10至图14中示出的无创可调式楔形截骨装置的实施方式所描述的开槽横向孔。另外，外壳530可具有开槽第二孔586。虽然开槽横向孔507可呈现大致竖直的长方形，但是开槽第二孔586可呈现大致水平长方形。开槽第二孔586可具有长度L和宽度W，如图24所示。长度L可被配置成略大于用于将无创可调式楔形截骨装置500固定到骨的骨螺钉的直径，使得骨螺钉能够穿过开槽第二孔586。宽度W可选择成使得骨螺钉能够在开槽第二孔586内水平枢转或成角度地移位。在一些实施方式中，开槽第二孔586被配置成使用5mm骨螺钉，长度L可介于约5mm到约5.2mm或者约5.1mm，并且宽度W可介于约6mm到约9mm或者约7mm。在一些实施方式中，宽度W与长度L之比(即，W/L)可介于约1.08到约1.65之间，或约1.25到约1.54，或者约1.37。开槽横向孔507和开槽第二孔586位于外壳530的第一端568附近。如图25所示，外壳530的第二端570在过渡点572处从第一端568倾斜。在一些实施方式中，角度578介于约2°至18°、约4°至16°、约6°至14°、约8°至12°和约10°，或者对于任何给定患者具有临床意义的任何其他角度。开槽第二孔586可包括前开口588和后开口590，可相对于第一端568取向为角度576。在一些实施方式中，角度576介于约70°至100°之间、约75°至95°、约80°至90°或约85°，或者对于任何给定患者具有临床意义的任何其他角度。图23还图示了具有内螺纹597的接口566，其可用于能释放地拆卸插入工具。类似于上述内容，无创可调式楔形截骨装置500可用手插入或者可附接至插入工具(例如钻引导件)。在一些实施方式中，包括内螺纹597的接口566位于第一端568处或附近以与插入工具的阳螺纹可逆地接合。另选地，这样的接合特征可位于内轴532处或附近。在其他实施方式中，系绳(例如；可拆卸的系绳)可附接至无创可调式楔形截骨装置500的任一端，使得系绳可在放置不正确的情况下容易被移除。
图26至图29图示了无创可调式楔形截骨装置500的开槽第二孔586如何结合开槽横向孔507工作以有利地促进增加胫骨102的第一部分119和第二部分121之间的角度矫正量的可能性。图示的第一骨螺钉134仅仅没有头部，所以第一骨螺钉134的轴在开槽第二孔586内可见。在图26中，截骨118基本上闭合并且内轴532尚未从外壳530显著牵引。第一骨螺钉134可(至少初始)优选地相对于开槽第二孔586的宽度W居中地取向。在图27中，内轴532从外壳530进一步牵引。随着外壳530的移动，其向上推动第一骨螺钉134和第二骨螺钉136，这又向上推动胫骨102的第一部分，导致胫骨119的第一部分围绕铰链枢转。随着胫骨的第一部分的枢转，第二骨螺钉136在开槽横向孔507内枢转，如关于本文中公开的其他实施方式(诸如无创可调式楔形截骨装置400)描述的。在第二骨螺钉136枢转的同时，第一骨螺钉134可向内侧(即，朝向图27的左侧)滑动。在图28中，内轴532被更进一步向外壳530之外牵引。随着第二骨螺钉136在开槽横向孔507内更进一步枢转，第一骨螺钉134可相对于开槽第二孔586的宽度W被强制回到中心部位。在图29中，内轴532被更进一步向外壳530之外牵引，并且随着第二骨螺钉136在开槽横向孔507内更进一步枢转，第一骨螺钉134可向外侧(即，朝向图27的右侧)滑动。开槽第二孔586沿着宽度W的长形取向可有利地在无创可调式楔形截骨装置500将胫骨102的第一部分119从第二部分121牵引时为它的移动添加额外的自由度，并且允许增加成角的量，例如，总共介于约10°至22°之间、约12°至20°、约14°至18°或约16°，或者对于任何给定的患者具有临床意义的任何其他成角的度数。不具有开槽横向孔507和开槽第二孔586二者的装置(例如，包括本文中公开的其他无创或侵入的可调式楔形截骨装置)可能够实现约16°的成角。然而，对于这样的装置，这样做可能导致胫骨102的第一部分119和第二部分121之间的轴向延长，与仅仅改变第一部分119和第二部分121之间的角度相反。胫骨的第一部分119和第二部分121之间的轴向延长可能导致通过胫骨102的第一部分119和第二部分121之间的连接而形成的铰链450的不需要的且有害的应力和/或甚至断裂(图15中示出)。如果第一部分119从第二部分121断裂且远离胫骨102的其余部分，则第一部分119可以远离第二部分121被轴向地或不成角度地牵引，并且不会矫正膝关节104的角度。因此，将开槽横向孔507和开槽第二孔586二者并入无创可调式楔形截骨装置500中可允许完整的16°成角(以上)，很少或没有轴向伸长，这可以有利地在不显著损害铰链450的情况下实现。在一些情况下，可达到高达25°的成角，同时在胫骨102的顶表面上仍维持相同的前后斜率。
在一些实施方式中，可使用开槽横向孔407、507的另选例。图33至图34图示了用于实现骨螺钉枢转的沙漏形孔。(例如，无创可调式楔形截骨装置600的)壁602可具有穿过壁602的锥形或沙漏形孔606。锥形或沙漏形孔606可具有直径沿着其长度变化的圆形横截面。随着如本文中公开的楔形截骨装置的牵引/缩回，允许第二骨螺钉136例如从图33中的位置枢转到图34中的位置。枢转的程度直接取决于直径的变化：外径越大，允许的枢转越多。设想锥形或沙漏形孔606的实施方式可允许枢转角度(即，最大枢转到最大枢转的程度，诸如图33中示出的第二骨螺钉136与图34中示出的第二骨螺钉136之间的角度差)介于约5°至40°之间、约10°至35°、约15°至30°，以及约20°至25°，或者对于任何给定的患者具有临床意义的任何其他角度。
在一些实施方式中，可使用如图35至图37中图示的开槽第二孔586的其他另选例。图35至图37图示了用于实现骨螺钉枢转的偏心轴承型孔。例如，孔626可合并入如本文中公开的无创可调式楔形截骨装置(诸如无创可调式楔形截骨装置620)的壁中。在一些实施方式中，孔626被配置成当无创可调式楔形截骨装置620被植入到胫骨102中时沿大致从前向后/从后向前的取向上延伸。在其他实施方式中，孔626被配置成当无创可调式楔形截骨装置620被植入到胫骨102中时在大致从内向外/从外向内的取向上延伸。在其他实施方式中，孔626以从内向外以及从前向后之间的角度延伸穿过无创可调式楔形截骨装置620。在一些实施方式中，孔626可以大致垂直于无创可调式楔形截骨装置620的纵向轴线的角度延伸穿过无创可调式楔形截骨装置620。在其他实施方式中，孔626可以不垂直于无创可调式楔形截骨装置620的纵向轴线的角度延伸穿过无创可调式楔形截骨装置620，例如偏离垂直约l°至30°、偏离垂直约2°至25°、偏离垂直约3°至20°、偏离垂直约4°至15°或偏离垂直约5°至10°或者以对于任何给定的患者具有临床意义的任何其他偏离垂直的角度延伸穿过无创可调式楔形截骨装置620。偏心轴承622可旋转地保持在孔626内。偏心轴承622可由润滑材料(例如，PEEK、UHMWPE，等)制成以有利地降低系统摩擦。偏心轴承622具有使物体可从中穿过放置(例如，第一骨螺钉134)的偏心孔628。当牵引包含如图35至图37所示的偏心轴承622的无创可调式楔形截骨装置620时，偏心孔628(由此延伸穿过偏心孔628的任何物体，诸如第一骨螺钉134)相对于孔626例如在第一旋转方向624上旋转。图35示出了近似七点钟的位置；图36示出了近似十点钟的位置；而图37示出了近似两点钟的位置。偏心轴承622可例如利用卡扣、制动器、焊接、胶合、环氧树脂或任何其他适用于本申请的固定手段固定地保持在无创可调式楔形截骨装置620的孔626内。另选地，偏心轴承622可由用户插入到孔626中。第一骨螺钉134在偏心轴承622内的运动可具有类似于第一骨螺钉134在开槽第二孔586内的运动(已关于图26至图29讨论)的特性，而除了延伸穿过偏心孔628的物体的向外侧(即，左右)运动之外，偏心轴承622可允许延伸穿过偏心孔的物体相对于无创可调式楔形截骨装置620的一些附加运动，例如延伸穿过偏心孔628的物体的竖直(即，上下)运动。
在图38中，长形孔702以大致水平的方式切入或钻入胫骨102的上部119中。长形孔702具有第一端704(在此示出为外侧)和第二端706(在此示出为内侧)。如图40所示的无创可调式楔形截骨装置700可放置于在胫骨102内钻出或扩出的髓管内，并且第一骨螺钉734经由锚孔716插入到无创可调式楔形截骨装置700中。在一些实施方式中，锚孔716具有内螺纹部分722，内螺纹部分722被配置成接合第一骨螺钉的阳螺纹710。第一骨螺钉734具有头部718和远端720。长形孔702(图38至图40中示出)钻过第一皮层712和第二皮层714。然后，第一骨螺钉的远端720可插入穿过长形孔702。在一些实施方式(包括图40中示出的实施方式)中，阳螺纹710与第一皮层712接合，从而切割第一皮层712的骨中的局部螺纹并且允许阳螺纹710穿过第一皮层712。一旦阳螺纹710已穿过第一皮层712，阳螺纹710就可旋拧到锚孔712的内螺纹部分722中，从而将骨螺钉734固定/锁定/紧固到无创可调式楔形截骨装置700。因为骨螺钉734仅能在中间被旋拧(即，具有平滑的颈部和平滑的远端)，所以骨螺钉734可沿着胫骨102的上部119中的长形孔702从第一端704滑动或移位到第二端706，而所有中间螺纹部分保持固定到无创可调式楔形截骨装置700。
随着无创可调式楔形截骨装置700被牵引，第一骨螺钉134、734能够在截骨118的角度增加的同时追随路径708(图38中示出)，并且随着第一骨螺钉134、734远离长形孔702的第一端704并朝向长形孔702的第二端706移动，如图38和图39所示。在一些实施方式中，第一骨螺钉134可置换为插入穿过无创可调式楔形截骨装置700中的锚孔的销。可使用紧密配合、摩擦配合、卡扣配合、弹簧配合等来锚定这样的销。
图41至图42图示了已植入并固定到胫骨102的上部119中的无创可调式楔形截骨装置740的一个实施方式。除能与本申请别处公开的元件互换的许多其他元件之外，无创可调式楔形截骨装置740包括弯曲的前后销744和骨螺钉742。无创可调式楔形截骨装置740可如本文中关于其他实施方式描述的那样，配置成在牵引或缩回无创可调式楔形截骨装置740期间允许骨螺钉742枢转、移位、滑动或以其他方式移动。在一些实施方式中，弯曲的前后销744具有可以插入穿过无创可调式楔形截骨装置740的孔(诸如锚孔)的弯曲中心部分750、第一直端部746和第二直端部748。
为了插入弯曲的前后销744，可在胫骨102的上部119的每个皮层(从前向后/从后向前)中钻孔。弯曲的前后销744可插入到第一部分119的第一侧中的孔，穿过无创可调式楔形截骨装置740，并到达第一部分119的第二侧中的孔之外。从而，弯曲的前后销744可通过使用第一直端部746和第二直端部748旋转地接合第一部分119和无创可调式楔形截骨装置740。当牵引无创可调式楔形截骨装置740时，弯曲的前后销744可有利地在孔内(围绕第一直端部746和第二直端部748)旋转，从而允许无创可调式楔形截骨装置740的锚孔在外侧或内侧方向上移动并且促进在多个轴线上同时移位(如关于本文中的其他实施方式描述的)。
图43至图44图示了植入到胫骨102内的无创可调式楔形截骨装置900的一个实施方式。无创可调式楔形截骨装置900包括外壳902和内轴904，内轴904可伸缩地位于外壳902内。图43至图44图示了两个远侧骨螺钉138、142。但是，应该理解的是，可使用任何数量的骨螺钉。以相同的方式，图43至图44仅图示了单个近侧骨螺钉136。再次，应该理解的是，这仅是出于说明的目的，并且超过一个骨螺钉(例如，2个骨螺钉)可用于将无创可调式楔形截骨装置900锚定到胫骨102的第一部分119。第二近侧骨螺钉(类似于图15至图20的骨螺钉134)可被包含并且可提供使胫骨102的上部119和下部121相对于胫骨102的纵向轴线旋转地稳定的有利益处。
在一些实施方式中，由内轴904的外表面上的纵向凹槽910以及径向凸起912来维持外壳902和内轴904之间的旋转取向，径向凸起912从外壳902的内表面延伸并被配置成在纵向凹槽910内滑动。在致动期间，螺钉136的旋转可以较大的角度在外壳902上牵拉；因此，外壳902和内轴904可有利地能够相对于彼此纵向平移。无创可调式楔形截骨装置的内容物可有利地免受身体内的恶劣环境影响。例如，O形环密封件906可容纳到外壳902的内部中的周向凹槽908内，以在外壳902和内轴904之间提供动态密封。
在一些实施方式中，磁体914经由径向轴承918被内轴904的端部旋转地承载。磁体914可承载在可旋转的磁体壳体(未示出)内。齿轮级920、922、924将磁体914联接到导螺杆926。导螺杆926(例如，由联接器928)非刚性地联接到最终齿轮级(即，齿轮级924)的输出端，并且可由销930保持在适当位置。磁体914可由外部移动磁场旋转，从而导致导螺杆926旋转。可使用降档传动比，使得需要多次旋转磁体914来导致导螺杆926旋转一次。上文包括可使用的齿轮级(诸如行星齿轮级)的额外描述和示例。在一些实施方式中，不包括齿轮级，留下1:1的传动比(即，磁体914的一次旋转导致导螺杆926的一次旋转。导螺杆926的旋转导致可具有远侧支点934的螺母932的纵向移动。螺母932的内螺纹936螺旋地啮合导螺杆926的外螺纹938。导螺杆926在第一旋转方向940上的旋转导致螺母932在第一纵向方向942上移动，迫使远侧支点934抵靠接触部位944处的骨螺钉136，导致骨螺钉136和胫骨102的上部119大致遵循弯曲路径946(一般在接触部位944周围)。在一些实施方式中，骨螺钉136和远侧支点934之间可能发生一些滑动(也就是说，远侧支点934不是无滑动地固定在单个点处的纯支点)。由此导致楔形截骨118张开，如图44所示。在一些实施方式中，调节无创可调式楔形截骨装置900不会直接导致外壳902相对于内轴904纵向地移动(这已经在某些其他实施方式中公开)。相反，外壳902和内轴904可相对于彼此被动地纵向移动，以适应由于骨螺钉136和胫骨102的上部119在调节期间(例如从图43的状态调节到图44的状态)枢转而可能发生的长度变化。
图45至图46图示了植入到胫骨102内的无创可调式楔形截骨装置950的一个实施方式。无创可调式楔形截骨装置950包括外壳952和内轴954，内轴954可伸缩地位于外壳952内。图45至图46图示了两个远侧骨螺钉138、142。但是应该理解的是，可使用任何数量的骨螺钉。第一骨螺钉134用于将枢转构件956固定到胫骨102的上部119。第一骨螺钉134穿过锚孔958。在一些实施方式中，锚孔958被配置成允许第一骨螺钉134和枢转构件956的锚孔958之间的旋转。穿过枢转构件956的倾斜锚孔960允许第二骨螺钉136通过。倾斜锚孔960的直径可正好大于骨螺钉136的直径。因此，当骨螺钉136被插入穿过倾斜锚孔960时，骨螺钉136相对于枢转构件956保持基本固定(即，倾斜锚孔960不允许第二骨螺钉136大致相对于枢转构件956枢转或摆动)。枢转构件956可由枢转接头962联接到外壳952。无创可调式楔形截骨装置950的内部部件可类似于本文中关于其他实施方式(包括图5至图7所示的其他实施方式)描述的内部部件。
图45示出了处于基本未牵引状态下的无创可调式楔形截骨装置950，而图46示出了处于牵引状态下的无创可调式楔形截骨装置950。随着内轴954从外壳952被牵引，枢转构件956、胫骨102的上部119和第二骨螺钉136枢转，第二骨螺钉和枢转构件956围绕枢转接头962相对于外壳952和胫骨102的下部121枢转，由此导致楔形截骨118成角度地张开并且导致胫骨102的上部119围绕接头/铰链枢转。在一些实施方式中，枢转构件956能枢转地联接到内轴954，而非外壳952。在一些实施方式中，可枢转接头962可置换为球窝接头，以允许枢转构件956和外壳952之间的额外自由度。
纵观所呈现的实施方式，径向极化的永磁体(例如图6的368)用作在无创可调式楔形截骨装置中生成移动的无创可致动的驱动元件。图47至图50示意性地示出四个另选实施方式，其中其他类型的能量转移被用来代替永磁体。
图47图示了无创可调式楔形截骨系统1300的一个实施方式，其包括具有第一植入部分1302和第二植入部分1304的植入物1306，第二植入部分1304能相对于第一植入部分1302无创地移位。第一植入部分1302被固定到主体197的第一部分，并且第二植入部分1304被固定到位于患者191内的主体199的第二部分。马达1308能操作以导致第一植入部分1302和第二植入部分1304相对于彼此移位。在一些实施方式中，外部调节装置1310具有用于供操作者输入的控制面板1312、显示器1314和发射器1316。发射器1316将控制信号1318经患者191的皮肤195发送到被植入接收器1320。被植入接收器1320可经由导体1322与马达1308通信。马达1308可由可植入式电源(例如，电池)供电，或者可通过电感耦合供电或充电。
图48图示了无创可调式楔形截骨系统1400的一个实施方式，其包括具有第一植入部分1402和第二植入部分1404的植入物1406，第二植入部分1404能相对于第一植入部分1402无创地移位。第一植入部分1402被固定到主体197的第一部分，并且第二植入部分1404被固定到位于患者191内的主体199的第二部分。超声波马达1408能操作以导致第一植入部分1402和第二植入部分1404相对于彼此移位。在一些实施方式中，外部调节装置1410具有用于供操作者输入的控制面板1412、显示器1414和超声波换能器1416，超声波换能器1416联接到患者191的皮肤195。超声波换能器1416产生穿过患者191的皮肤195并且操作超声波马达1408的超声波1418。
图49图示了无创可调式楔形截骨系统1700的一个实施方式，其包括具有第一植入部分1702和第二植入部分1704的植入物1706，第二植入部分1704能相对于第一植入部分1702无创地移位。第一植入部分1702被固定到主体197的第一部分，并且第二植入部分1704被固定到位于患者191内的主体199的第二部分。形状记忆致动器1708能操作以导致第一植入部分1702和第二植入部分1704相对于彼此移位。在一些实施方式中，外部调节装置1710具有用于供操作者输入的控制面板1712、显示器1714和发射器1716。发射器1716将控制信号1718经患者191的皮肤195发送到被植入接收器1720。被植入接收器1720可经由导体1722与形状记忆致动器1708通信。形状记忆致动器1708可由可植入式电源(例如，电池)供电，或者可通过电感耦合供电或充电。
图50图示了无创可调式楔形截骨系统1800的一个实施方式，其包括具有第一植入部分1802和第二植入部分1804的植入物1806，第二植入部分1804能相对于第一植入部分1802无创地移位。第一植入部分1802被固定到主体197的第一部分，并且第二植入部分1804被固定到位于患者191内的主体199的第二部分。液压泵1808能操作以导致第一植入部分1802和第二植入部分1804相对于彼此移位。在一些实施方式中，外部调节装置1810具有用于供操作者输入的控制面板1812、显示器1814和发射器1816。发射器1816将控制信号1818经患者191的皮肤195发送到被植入接收器1820。被植入接收器1820经由导体1822与液压泵1808通信。液压泵1808可由可植入式电源(例如，电池)供电，或者可通过电感耦合供电或充电。液压泵1808可另选地置换为气动泵。
在本文中公开的楔形截骨装置的一些实施方式中，开槽孔可位于在内轴上而非外壳上或除外壳之外。植入物在胫骨内的取向可能与任何附图中图示的取向相反。另外，无创可调式楔形截骨装置的任何实施方式可用于逐渐牵引(Ilizarov骨生成)或不正确角度的急性矫正。并且，在一些实施方式中，另选地，上述远程调节可置换为任何植入部分的手动控制，例如患者或护理人员手动按压放置在皮肤之下的按钮。
当然，前文描述了本发明的某些特征、方面和优点，可以在不脱离本发明的精神和范围的情况下作出各种改变和修改。由此，例如，本领域技术人员将认识到，本发明可以以实现或优化如本文中教导的一个优点或一组优点的方式来体现或进行，而不必实现本文中可能教导或建议的其他目的或优点。另外，虽然本发明的多种变型已详细地示出和描述，但是基于本公开，落入本发明的范围内的其他修改和使用方法对本领域技术人员将是显而易见的。设想可作出不同实施方式之间和之中的特定特征和方面的各种组合或子组合并且其仍落入本发明的范围内。因此，应该理解的是，所公开的实施方式的各种特征和方面可以彼此组合或替代，以便形成所讨论的装置、系统和方法的不同模式(例如，通过排除某些实施方式的特征或步骤，或者将来自系统或方法的一个实施方式的特征或步骤添加到系统或方法的另一实施方式)。
相关申请的交叉引用
本申请要求2015年10月16日提交的未决美国临时专利申请号62/242,931的优先权及权益。

Claims (25)

1.一种用于改变对象的骨的角度的系统，该系统包括：
无创可调式植入物，所述无创可调式植入物被配置成放置在所述骨的内部的纵向空腔内侧并且包括外壳和以可伸缩的方式布置在所述外壳中的内轴，所述外壳和内轴中的至少一者与第一锚孔和第二锚孔关联，所述第一锚孔被配置成供用于将所述可调式植入物联接到骨的第一部分的第一锚定器穿过并且所述第二锚孔被配置成供用于将所述可调式植入物联接到骨的所述第一部分的第二锚定器穿过，所述内轴被配置成联接到骨的从骨的所述第一部分分离或能够从所述第一部分分离的第二部分，使得所述可调式植入物的无创伸长会导致所述内轴从所述外壳延伸并且使骨的所述第一部分和骨的所述第二部分成角度地移开；
驱动元件，所述驱动元件被配置成能远程操作以使所述内轴相对于所述外壳以可伸缩的方式移位；并且
其中，所述第一锚孔被配置成当所述内轴相对于所述外壳进行伸缩移位时允许所述第一锚定器在至少第一角度方向上枢转，并且
其中，所述第二锚孔被配置成当所述内轴相对于所述外壳进行伸缩移位时允许所述第二锚定器在至少第一平移方向上平移。
2.根据权利要求1所述的系统，其中，所述第一锚孔被配置成允许所述第一锚定器在与所述第一角度方向相反的第二角度方向上枢转。
3.根据权利要求1所述的系统，其中，所述第二锚孔被配置成允许所述第二锚定器在与所述第一平移方向相反的第二平移方向上平移。
4.根据权利要求1所述的系统，其中，所述内轴与第三锚孔关联，所述第三锚孔被配置成供用于将所述可调式植入物联接到骨的所述第二部分的第三锚定器穿过。
5.根据权利要求1所述的系统，其中，所述第一锚孔被配置成允许所述第一锚定器在与所述第一角度方向相反的第二角度方向上枢转，并且其中所述第二锚孔被配置成允许所述第二锚定器在与所述第一平移方向相反的第二平移方向上平移。
6.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。
7.根据权利要求6所述的系统，其中，所述永磁体包括径向极化的稀土磁体。
8.根据权利要求1所述的系统，其中，所述驱动元件包括马达。
9.根据权利要求1所述的系统，其中，所述驱动元件包括感应耦合马达。
10.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。
11.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。
12.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驱动的致动器。
13.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。
14.根据权利要求1所述的系统，其中，所述第一锚孔大致沿着接近所述可调式植入物的径向截面的第一平面延伸，并且所述第二锚孔大致沿着接近所述可调式植入物的径向截面的第二平面延伸，并且其中，所述第一平面大致正交于所述第二平面。
15.根据权利要求14所述的系统，其中，所述第一锚孔和所述第二锚孔不垂直于彼此延伸。
16.根据权利要求1所述的系统，其中，所述无创可调式植入物被配置成改变具有膝骨关节炎的对象的胫骨的角度。
17.根据权利要求16所述的系统，其中，所述无创可调式植入物被配置成将胫骨的角度改变大于12度。
18.根据权利要求16所述的系统，其中，所述无创可调式植入物被配置成将胫骨的角度改变大于16度。
19.根据权利要求16所述的系统，其中，所述无创可调式植入物被配置成相对于与所述胫骨关联的膝关节在外侧方向上调节机械轴线。
20.根据权利要求19所述的系统，其中，所述无创可调式植入物被配置成将机械轴线调节到距与所述胫骨关联的所述膝关节的中心点靠外至少30％的位置。
21.根据权利要求1所述的系统，其中，所述第二锚孔是长形槽。
22.根据权利要求1所述的系统，其中，所述第二锚孔具有第一直径并且进一步包括偏心轴承，所述偏心轴承的外径被配置成接合所述第二锚孔，所述偏心轴承具有被配置成供所述第二锚定器穿过的内孔。
23.根据权利要求1所述的系统，其中，所述第一锚定器为骨螺钉。
24.根据权利要求1所述的系统，其中，所述第二锚定器为骨螺钉。
25.根据权利要求1所述的系统，其中，所述第一锚孔和所述第二锚孔中的一者包括居中地位于其中的凸起部分。
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