CN102905625A - 骨生长装置及方法 - Google Patents

骨生长装置及方法 Download PDF

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CN102905625A
CN102905625A CN2010800394427A CN201080039442A CN102905625A CN 102905625 A CN102905625 A CN 102905625A CN 2010800394427 A CN2010800394427 A CN 2010800394427A CN 201080039442 A CN201080039442 A CN 201080039442A CN 102905625 A CN102905625 A CN 102905625A
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permanent magnet
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CN102905625B (zh
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斯科特·普尔
布莱尔·沃克
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Norwich company specialized in Department of orthopedics.
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Ellipse Technologies Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1725—Guides or aligning means for drills, mills, pins or wires for applying transverse screws or pins through intramedullary nails or pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66—Alignment, compression or distraction mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8866—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices for gripping or pushing bones, e.g. approximators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches
    • A61B17/8886—Screwdrivers, spanners or wrenches holding the screw head
    • A61B17/8888—Screwdrivers, spanners or wrenches holding the screw head at its central region
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A61B2017/681—Alignment, compression, or distraction mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Abstract

一种包括壳体和牵拉轴的髓内延长装置。该髓内延长装置放置在两个骨骼段的腔体内(为了插入该装置，而已分离或者有目的地分离)。髓内延长装置的牵拉轴例如经一个或多个连接螺杆而附接到两个骨骼段中的一个骨骼段。利用例如一个或多个附接螺杆将髓内延长装置的壳体附接到第二骨骼段。在治疗期间，骨骼被连续地牵拉而形成新的分离，可以在该分离中进行骨骼生成。在一个实施例中，所述髓内延长装置包括可以相互附接的促动器和延伸杆。

Description

骨生长装置及方法
相关申请
本申请要求于2009年9月4日提交的美国临时专利申请第61/240,071号以及于2010年7月13日提交的美国临时专利申请第61/363,986号的优先权。第240,071和363,986号的临时专利申请通过引用方式整体结合于此。
技术领域
本发明的领域总体上涉及用于治疗与骨骼系统有关的疾病，特别是涉及用于骨骼生长用途的医疗器械。
背景技术
牵张成骨(也称为骨痂牵拉和骨牵张)已成功地用于延长身体的长骨。通常，通过骨皮质切开术来有目的地使骨骼断裂(如果未曾断裂)并将骨骼的两段逐渐地牵拉，从而允许在间隙中形成新骨。如果牵引速率过高，则存在发生骨不连接的危险，如果牵引速率过低，则存在在牵引期结束前这两段骨骼将彼此完全融合的危险。当利用此方法达到骨骼的期望长度时，则让骨骼合并。牵张成骨的应用主要集中于股骨或胫骨的生长，但也可包括肱骨、颌骨(小颌畸形)或者其他骨。使骨延长或生长的原因是多种的，该用途包括但不限于：骨肉瘤后的骨癌；矮小症或侏儒症/软骨发育不全中的装饰性延长(小腿以及股骨和/或胫骨)；一个肢体的延长以适应另一肢体(先天性、创伤后、骨骼疾病后、假肢膝关节)，骨不连接(non-union)。
使用外固定器的牵张成骨已实施了许多年，但是，外固定器对于患者而言是不方便的。也可能是痛苦的，患者会遭受销轨感染、关节僵直、食欲缺乏、抑郁、软骨损伤以及其他副作用的危害。安装外固定器也会延迟康复的开始。
针对外固定器牵拉的缺点，已使得髓内牵引钉被手术地植入体内，其整个包含于骨骼中。一些方法是，通过患者肢体的反复旋转而自动地延长。这样有时会给患者带来痛苦并经常以不受控制的方式进行。因此，这导致难以遵守严格的每日或每周延长方案，而这种严格的每日或每周的延长方案可避免发生骨不连接(如果过快)或早期固结(如果过慢)。下肢牵引速率约为每天1毫米左右。现已开发出其他髓内钉，其具有植入的电动机且可加以遥控。电动机驱动的髓内钉具有需植入皮下的天线，因此使外科手术复杂化并使其更具侵害性。因此，这些装置被设计成以受控制的方式延长，但是，由于其复杂性，因此可能不能制成价格可承受的产品。其他方法是所推荐的包含植入磁体的髓内牵张器，该牵张能够以电磁方式由外部定子(即，大电磁体)驱动牵引。由于外部定子的复杂性和尺寸的原因，此项技术尚未简化成可以带回家让患者实施每日延长的、简单的具高性价比的装置。
发明内容
在第一实施例中，一种延长装置被构造成置于具有第一分离段和第二分离段的骨骼的内部或者穿越该骨骼。该装置包括：壳体，被构造成附接至所述第一分离骨骼段和第二分离骨骼段之一；牵拉轴，具有沿其长度的内腔，并且被构造成附接至所述第一分离骨骼段和第二分离骨骼段中的另一骨骼段。所述装置包括永久磁体，其被构造成相对于所述壳体旋转并且具有至少两个极，所述永久磁体操作地耦接至导螺杆，所述导螺杆与所述牵拉轴的内腔的螺纹部分接合。推力轴承设置在所述壳体内并且介于所述导螺杆与所述永久磁体之间，所述推力轴承夹在所述壳体中的第一支台与第二支台之间。
在第二实施例中，延长装置被构造成置于具有第一分离段和第二分离段的骨骼的内骨髓管内。该装置包括：壳体，被构造成附接至所述第一分离骨骼段和第二分离骨骼段之一；和牵拉轴，具有沿其长度的内腔，并且被构造成附接至所述第一分离骨骼段和第二分离骨骼段中的另一骨骼段。永久磁体设置在所述壳体内并且构造成用于旋转并具有至少两个孔。行星齿轮组设置有多个齿轮，其中，所述齿轮中的一个齿轮操作地耦接至所述永久磁体并被构造成传递扭矩，并且其中，所述多个齿轮中的另一个齿轮终止于操作地耦接至导螺杆的输出轴，所述导螺杆与所述牵拉轴的内腔的螺纹部分接合。
在第三实施例中，延长系统构造成放置在骨骼的内骨髓管内。所述系统包括：促动器，包括包含可旋转永久磁体和可移动牵拉轴的壳体，所述可移动牵拉轴相对于所述壳体可伸缩地安装，所述可移动牵拉轴经导螺杆操作地耦接至所述可旋转永久磁体，其中，所述牵拉轴的远端被构造成附接到所述骨骼的第一区，并且其中，所述促动器的近端包括几何成型的凸型轮毂。所述系统进一步包括延伸杆，延伸杆在其一端具有几何成型的凹型轮毂，所述凹型轮毂被构造成固定至设置在所述促动器上的几何成型的凸型轮毂，其中，所述延伸杆的相对端被构造成附接到所述骨骼的第二区。
在又一个实施例中，延长系统构造成置于骨骼的内骨髓管内。该系统包括：促动器，包括包含可旋转永久磁体和可移动牵拉轴的壳体，所述可移动牵拉轴相对于所述壳体可伸缩地安装，所述可移动牵拉轴经导螺杆操作地耦接至所述可旋转永久磁体，其中，所述牵拉轴的远端被构造成附接到所述骨骼的第一区，并且其中，所述促动器的近端包括几何成型的凹型轮毂。所述系统进一步包括延伸杆，延伸杆在其一端具有几何成型的凸型轮毂，所述凸型轮毂被构造成固定至设置在所述促动器上的几何成型的凹型轮毂，其中，所述延伸杆的相对端被构造成附接到所述骨骼的第二区。
在本发明的又一方面中，用于调节可调节植入物的外部调节装置包括电源、控制模块、以及包含至少一个永久磁体的手持装置。该手持装置被构造成放置在患者肢体的第一侧，该至少一个永久磁体被构造成转动位于可调节植入物内的圆柱形磁体。控制模块被构造成限制位于可调节植入物内的圆柱形磁体的转数。
附图说明
图1示出了根据一个实施例的位于骨骼内的髓内延长装置的侧视图。
图2示出了图1的髓内延长装置的侧视图。
图3A示出了沿图2中的线3A-3A截取的图1和图2的髓内延长装置的截面图。
图3B示出了图3A的髓内延长装置的圆圈3B的区域的局部放大视图。
图3C示出了沿图2中的线3C截取的图1和图2的髓内延长装置的截面图。
图4A示出了前述图的髓内延长装置的多个内部构件的视图。
图4B示出了被构造成用于前述附图的髓内延长装置的唇形密封件。
图5示出了前述附图的髓内延长装置的驱动机构的多个内部构件的局部放大视图。
图6示出了外部调节装置的透视图。
图7示出了图6的外部调节装置的磁力机头(handpiece)的分解图。
图8示出了位于患者下部大腿周围的现有技术的电磁外部装置的截面图。
图9示出了位于患者下部大腿上的图6和图7的外部调节装置机头的截面图。
图10示出了用于模块化髓内延长装置的可消毒成套组件。
图11示出了根据一个实施例的模块化髓内延长装置。
图12示出了图11的髓内延长装置的促动器的一端。
图13示出了模块化髓内延长装置的延伸杆。
图14示出了图13的延伸杆的第二视图。
图15示出了用于模块化髓内延长装置的插入和附接的近端钻导件。
图16示出了用于拆除模块化髓内延长装置的拆除工具。
图17示出了用于将延伸杆附接到模块化髓内装置促动器的扭矩限制驱动器。
图18示出了模块化髓内延长装置的促动器的截面。
图19示出了磁力机头与髓内延长装置之间的间隙(G)。
图20示出了用于髓内延长装置的锁定螺杆驱动器。
图21A示出了用于髓内延长装置的锁定螺杆。
图21B示出了沿图21A的线21B-21B截取的图21A的锁定螺杆。
具体实施方式
图1示出了髓内延长装置110的侧视图，其经过包含于骨骼100内的孔或内孔(bore)108而放置。可利用钻孔、扩孔等方法制成孔或内孔108，并且孔或内孔108可延伸经过密质骨骼(在端部)和网眼状(海绵状)骨骼。图1中所示的髓内延长装置110包括壳体112和牵拉轴114。为了使骨骼100生长或延长，骨骼100要么具有预先存在的分离106或者被有目的地切断或断裂以形成此分离106，从而将骨骼分成第一段102和第二段104。可在插入或固定髓内延长装置110之前或者可在插入装置110之后，进行切断，例如，利用柔性Gigli锯。利用一个或多个附接螺杆118将髓内延长装置110的牵拉轴114附接到第一段102。本领域技术人员所知的螺杆118以外的紧固件也可用于将牵拉轴114固定至骨骼100的第一段102。利用一个或多个附接螺杆116将髓内延长装置110的壳体112固定至骨骼100的第二段104。此外，螺杆116以外的紧固件可用于将壳体112固定至骨骼100的第二段104。
在治疗期间，将骨骼100连续地牵引，从而形成新的分离106，可以在分离106中发生骨骼生成。连续地牵引是指以规则方式(可以是大约每天1次或者每几天1次)进行牵引。示例性的牵引速率为每天1毫米，但是可采用其他牵引速率。也就是说，典型的牵引方案可包括髓内延长装置110的长度每天增加大约1毫米。进行的方式可以是，例如，每天有4个延长期，每个延长期具有0.25毫米的延长。髓内延长装置110(如下图中所示)具有磁力驱动系统，该系统允许牵拉轴114可伸缩地从壳体112内延伸出，因而迫使骨骼100的第一段102与第二段104相互分开。当实施牵引时，如果骨骼100是在位移段120内，则壳体112的一部分能够在第一段102的孔或内孔108内滑动。在骨骼内的髓内延长装置110的方向可以与图1中所示方向相反。例如，牵拉轴114可耦接到骨骼100的第二段104，壳体112可耦接到骨骼100的第一段102。例如，髓内延长装置110可从起始于骨骼100的远端的孔或内孔中逆向地放置。
转向图2至图5，髓内延长装置110具有一个或多个在牵拉轴114中的牵拉轴螺杆孔122，螺杆118(图1)可放置成穿过牵拉轴螺杆孔。同样地，壳体112附接到具有一个或多个壳体螺杆孔124的端盖130，螺杆116(图1)可放置成穿过壳体螺杆孔124。髓内延长装置110的壳体112包括：磁体壳体128和花键壳体126。可利用焊接、胶接或其他结合技术使这些壳体126、128相互附接。利用端盖130的附接而在一端(与花键壳体126接合的相反端)将磁体壳体128密封地封闭。可通过焊接、胶接或其他结合技术使端盖130附接到磁体壳体128。在使用中，利用导螺杆136将牵拉轴114从壳体112中推出，导螺杆136在螺母140内旋转，该螺母固定至与牵拉轴114的腔体137邻接的内表面。导螺杆136以间接方式机械耦接到容纳于磁体壳体128内的圆柱形永久磁体134。如以下更详细的说明，由外部调节装置180利用磁力驱动(图6)的圆柱形永久磁体134的旋转导致导螺杆136的旋转。
利用例如胶粘剂(如环氧树脂)将圆柱形磁体134固定地容纳于磁体盒158内。磁体盒158相对于磁体壳体128旋转。圆柱形磁体134可以是稀土磁体(如Nd-Fe-B)，并且除了被保护在磁体盒158内之外还可用聚对二甲苯或其他防护涂层涂布，例如，密封地用环氧树脂灌装。磁体盒158包括在附接到径向轴承132内部的端部上的轴160。轴向轴承132的外径固定至端盖130的内部。此布置允许圆柱形磁体134在最小扭转阻力下旋转。在其另外的相对端，磁体盒158包括附接到第一行星齿轮组154的轴161。轴161包括第一行星齿轮组154的太阳齿轮，该太阳齿轮使第一行星齿轮组154的行星齿轮转动。第一行星齿轮组154用于降低转速并增加所形成的从圆柱形磁体134向导螺杆136的扭矩传递。第二行星齿轮组156也图示在第一行星齿轮组154与导螺杆136之间，用于进一步降低速度并增大扭矩。可调整行星齿轮组的数量和/或齿轮的齿数，从而获得期望的速度和扭矩传递。例如，每英寸有八十(80)条螺纹的导螺杆附接到齿轮比为4∶1的两个行星齿轮组(各齿轮组在9毫米的装置内，在远端股骨中具有磁体位置)，在大于与外部装置的平均距离或间隙的情况下，可以获得至少100磅的牵引力(图9或图19)。行星齿轮组154、156向行星齿轮输出轴144输出。行星齿轮输出轴144延伸穿过推力轴承138并且固定(利用焊接等)到导螺杆联接帽146。利用锁定销142将导螺杆136固定至导螺杆联接帽146，锁定销142延伸穿过导螺杆136中的孔和导螺杆联接帽146中的孔。锁定销保持器148是包围锁定销14的圆筒体，将此组件保持在一起。以这种方式将导螺杆136附接到磁体/齿轮组件的剩余部分，确保了该设计不受到过分束缚，因而导螺杆136不与螺母140摩擦。此外，生物相容性润滑脂(例如KRYTOX)可用于运动部件(导螺杆、螺母、轴承、壳体、和牵拉轴)用以使摩擦损失最小化。导螺杆136能够在牵拉轴114的腔体137内旋转，并且仅需与长度短的螺母140啮合，此特征也使摩擦损失最小化。
推力轴承138用于保护驱动器的磁体/齿轮组件不受任何显著的压缩应力或拉伸应力的影响。推力轴承138是由两个分开的滚道组成，在两个滚道之间具有球轴承。当该装置上存在压缩力时，例如，当牵拉骨骼100因此对抗软组织的抗拉强度时，推力轴承138紧靠位于磁体壳体128内的磁体壳体支台或唇部150。另外，尽管该装置通常并不用于将骨骼拉到一起，但是，存在一些希望将骨拉到一起的用途。例如，在某些压缩钉的应用中，目的是将骨的两个断裂的段固定在一起。因为骨100可能已以不均匀或粉碎模式断裂，所以在被植入和完全附接之前难以确定钉的期望长度。在这些情况下，可能易于误判长度，并且这样的间隙会存在于骨之间。通过放置略微延伸的髓内装置110并将其固定，在装置110已固定在骨片段内之后可利用磁力来收缩该装置110，从而装置110在这两个片段之间施加期望的压缩力。在这些压缩钉用途中，在装置110上将会有张力，并且推力轴承138将会紧靠花键壳体支台或唇部152。在两种情况下，推力轴承138和壳体部中的一个壳体部的硬部承受较大应力，而不是驱动系统的磁体/齿轮组件承受较大应力。特别是，推力轴承138夹在支台或唇部150与支台或唇部152之间。
具体地，转向图4A和图5，壳体构件已被拆除而显示各种内部特征，包括允许牵拉轴114在壳体112内滑动并且也防止牵拉轴114可在壳体112内旋转的轴环。这使骨骼100获得充分的稳定性。牵拉轴114包含数个轴向槽166。槽166具有半圆形缺口截面，这允许数个球体164在其内部滚动。球体164被限制在线性球笼162内。在球体164和线性球笼162上配合的花键壳体126沿其内径表面具有轴向槽163(图3C)，其与牵拉轴114的轴向槽166相似。在此方面，球体164和球笼162介于牵拉轴114与花键壳体126之间。因此，球体164被线性球笼162保持在位，并且机械地将各槽相互锁定，因而阻止了牵拉轴114在壳体112内的旋转。然而，球体164能够在线性球笼162内滚动，因而允许牵拉轴114在具有非常低摩擦的情况下发生相对于壳体112的花键壳体126的轴向位移。唇形密封法兰168包括定制截面唇形密封件169(示于图4B中)，该密封件使牵拉轴114与花键壳体126之间的滑动密封成为可能，因而防止整个组件的内容物受到身体环境的影响。唇形密封件169包括基部173，基部对于唇形密封法兰168的内径(因此对于附接到唇形密封法兰168的花键壳体126)进行密封。唇形密封件169还包括可滑动地密封牵拉轴114的轴向槽166的突起171。唇形密封件169的内表面175可滑动地密封牵拉轴114的整个外径。也应当指出的是，唇形密封件169可由硅酮、EPDM或者其他橡胶材料制成，并且可用硅油涂布以增加润滑性。此外，可用硅油或液态全氟聚醚(如KRYTOX)涂布球体、槽和球笼，以增加润滑性。图5示出了磁体盒158的一部分，其被拆除从而可图示说明圆柱形磁体134的南极170和北极172。
图6示出了外部调节装置180，其用于利用传递扭矩的磁耦合来非侵入性地牵引髓内延长装置110。外部调节装置180包括磁力机头178、控制盒176和电源174。控制盒176包括控制面板182，控制面板具有一个或多个控制器(按钮、开关、或者触觉传感器、移动传感器、音频传感器或光传感器)及显示器184。显示器184可以是视觉显示器、听觉显示器、触觉显示器等或者上述特征物的一些组合。外部调节装置180可包含由医生编程的软件。例如，医生可能希望患者将外部调节装置180带回家，以便患者或患者的家庭成员或朋友进行植入患者的髓内延长装置110的每日牵引。然而，医生通过将其编程在控制盒176中能够防止操纵外部调节装置180的人过分牵拉患者。例如，医生可对控制盒176进行预先编程，以便能够实施每天仅一(1)毫米的牵引。另外，医生可以对控制盒176进行预先编程，使得在任意的2小时期间内牵拉距离不大于0.5毫米，或者在5分钟期间内牵拉距离不大于0.25毫米。这些设置可用来确保患者不能够对骨骼或组织造成严重损伤，也不会扰乱延长过程。
优选地，这种指令或限制可由医生(或甚至由制造商)以安全方式预先编程，使得使用者不能改变预先编程的设置。例如，可利用安全码来预编程并且改变每天的牵引限值(或其他参数)。在此实例中，操纵外部调节装置180的人将不能在1天内牵拉大于一(1)毫米(或者1天内大于2毫米)，并且将不具有能够改变外部调节装置180的此功能的安全码。其作为有用的锁定特征，防止髓内延长装置110的意外的过度延伸。该安全特征可监控例如外部调节装置180的磁体186的旋转运动，如以下更详细的描述，或者该安全特征可经由非侵入性传感装置来监控髓内延长装置110内的圆柱形磁体134的旋转。
图7示出了外部调节装置180的磁力机头178的细节，用以阐明外部装置的磁体186导致髓内延长装置110的圆柱形磁体134发生旋转的方式。
如图7中所示，存在两个(2)圆柱形形状的磁体186。磁体186是由稀土磁体制成。磁体186可具有与图5中所示圆柱形磁体134相同径向的两个极构造。磁体186被粘合或者被以其他方式固定在瓷杯187内。瓷杯187包括分别附接到第一磁体齿轮212和第二磁体齿轮214的轴198。利用齿轮传动系统(通过使用中心齿轮210，其与第一磁体齿轮212和第二磁体齿轮214啮合)来维持两个磁体186中的每个的极的彼此相对方向。例如，可能理想的是，每当一个磁体186的南极朝下时，另一个磁体186的南极朝上。此布置例如使可以作用于髓内延长装置110的圆柱形磁体134上的扭矩最大化。
在磁体板190与前板192之间，磁力机头178的各构件被固定在一起。大部分构件被盖216所保护。磁体186在静止磁体盖188内旋转，使得磁力机头178可直接地放置在患者上，而不向患者的外表面传递任何运动。在牵拉髓内延长装置110之前，操作者将磁力机头178放在患者的靠近圆柱形磁体134的位置，如图9中所示。介于两个磁体186之间的磁体支座194包括观察窗196，有助于放置。例如，可经观察窗196看到利用难以去除的记号笔在患者皮肤上的适当位置做出的标记。为了实施牵引，操作者利用手柄200握住磁力机头178并压下牵拉开关228，使得电动机202在第一方向上驱动。电动机202具有齿轮箱206，使得输出齿轮204的转速不同于电动机202的转速(例如较低转速)。然后，输出齿轮204转动与中心齿轮210啮合的减速齿轮208，从而导致其以不同于减速齿轮208的转速旋转。中心齿轮210与第一磁体齿轮212和第二磁体齿轮214啮合，使它们以彼此相同的转速旋转。根据放置有外部调节装置180的磁体186的身体位置，理想的是，控制此转速，从而使由有磁体186和圆柱形磁体134所赋予的经过身体组织和体液的所形成感应电流密度最小化。例如，包括60RPM或以下的磁体转速，但是可采用其他速度，例如35RPM或以下。在任何时候，均可通过压下回缩开关230来减小牵引。例如，如果患者感觉到明显疼痛、或者在此区域中的麻木正增加。
图8和图9中示出了将髓内延长装置110植入股骨220内的患者下部大腿218的截面。在图9中，所显示的本发明外部调节装置180的磁力机头178所在位置能够对髓内延长装置110的圆柱形磁体134进行调整。然而，在图8中，现有技术磁性定子“圆环(donut)”222的比例图显示了这两种设计的比较效率(图8示出了放置在现有技术磁性定子“圆环”222中的本文所描述类型的髓内延长装置110)。现有技术磁性定子“圆环”222较大、价格贵，并且难以运送到患者家进行每天调整。此外，使得圆形截面用作一个尺寸适合所有装置，并不是非常有效，这是由于数个原因：大部分肢体的截面并非圆形，骨骼通常并不位于肢体的中心并且患者的肢体具有许多不同尺寸。在图8中，将股骨骼放置成穿过磁性定子“圆环”中的圆形孔，并且大腿的后部232停留在磁性定子“圆环”222的下部226。磁场的强度根据距离的幂(例如平方反比)而下降，这取决于特定磁场几何形状的复杂性。因此，在任何磁设计中，理想的是，使得驱动磁场与被驱动磁体之间的距离尽可能小。患者下部大腿218的尺寸以及如何将大腿放置在图8中的磁性定子“圆环”222内的判断将产生几何形状，使得圆柱形磁体134与磁性定子“圆环”222的上部224之间的距离L1大致等于圆柱形磁体134与磁性定子“圆环”222的下部226之间的距离L2。然而，如果将大腿的前部234放置成抵靠磁性定子“圆环”222的上部224，那么长度L1将会变小而长度L2将会变大。因为各患者具有不同尺寸的肢体并且因为小肢体(如上臂)以及大肢体(如大腿)期望得到治疗，所以图8的磁性定子“圆环”222几乎不可能优化。因此，需产生超大磁场作为该装置的标准磁场，因而需要更多的支出(用于给此较大磁场供电的硬件)。这又意味着，各患者将暴露在比实际所需的更大的磁场和更大的组织和体液电流密度中。在一些实施例中，理想的是，在装置的工作期间，维持患者所暴露的磁场在2.0或以下特斯拉。根据另一个实施例，也理想的是，维持患者的组织和体液所暴露的电流密度不大于0.04安培/米2(rms)。此外，因为髓内延长装置110被固定在骨骼100上，所以不必要的大磁场会导致骨骼100的不需要的运动，例如，在圆柱形磁体134的任何径向方向上。如果磁场过高，那么可将患者的小腿移出理想位置，并且甚至可给患者造成一些烦恼(包括疼痛)。
如图9所示，外部调节装置180的磁力机头178的构造使磁体186将扭矩传递给髓内延长装置110的圆柱形磁体134的能力最优化，且不使患者暴露在大磁场中。这也允许髓内延长装置110的圆柱形磁体134被设计得尽量地小，从而减小植入物的外形，以便可嵌入小身材患者(诸如可能希望装饰性肢体延长的患者)的肱骨或者胫骨和股骨。如上所述，9毫米直径的髓内延长装置可以传递100磅的牵引力，甚至涵盖直径为8毫米和7毫米的装置。两个磁体186的交替变化方向(即，一个磁体186的北极对应于另一磁体186的南极)产生对于向圆柱形磁体134的扭矩传递相加作用，因此对于任何特定的圆柱形磁体134的尺寸而言使牵引力最大化。
此外，两个磁体186(例如70毫米)中心之间的分离(S)以及所形成的凹形轮廓238(图6和图7)与大部分肢体外表面的曲率一致，因而使得各磁体186与圆柱形磁体134之间的距离L3和L4尽量地小。这可以特别是利用磁力机头178的凹形轮廓238来协助。此外，皮肤和脂肪可被磁体盖188压缩，从而在一侧和两侧形成缺口236，这允许各磁体186与圆柱形磁体134之间的距离L3和L4变得更小。
图10示出了包括多个延伸杆406的消毒成套组件400，延伸杆被构造成附接到促动器412(图11)，从而构成模块化髓内延长装置410(图11)。在一个实施例中，促动器412是以无菌形式提供的，并且延伸杆406和消毒成套组件400的剩余内容物可利用高压釜(例如，水蒸汽)、环氧乙烷或者本领域技术人员已知的其他方法进行灭菌。消毒成套组件400内容物包括一个或多个延伸杆406和附件408，附件用于模块化髓内延长装置410的插入、附接。调节和拆除。内容物位于第一消毒托盘402和第二消毒托盘404内。第二消毒托盘404和第一消毒托盘402具有允许气体进入的多个孔405。在以下附图中的数个附图中，将对成套组件400中的其他物件进行描述。
转向图11，图中示出了模块化髓内延长装置410的组件。促动器412被设计成放置在患者的骨骼内(沿与图1的髓内延长装置110相反的方向)。因此，牵拉轴413的取向朝向骨骼的远端(远端是图11的向下方向)。牵拉轴413中的远端螺杆孔415允许放置远端锁定螺杆420。远端锁定螺杆420(图21A和图21B)具有用于与骨骼接合的近端螺纹417，而远端锁定螺杆420的轴419的剩余部分具有恒定的直径，用于获得最大的强度和稳定性。在促动器412的近端421存在六边形形状的凸型轮毂414，凸型轮毂包括在六边形凸型轮毂414的螺纹孔429内的横向定位螺丝416(图12)。延伸杆406(图13和图14)具有相应的六边形孔428或凹型端部，促动器412的六边形凸型轮毂414放置在该六边形孔或凹型端部。横向定位螺丝416嵌套在六边形凸型轮毂414的螺孔429内，使得当把横向定位螺丝416与六边形孔428放在一起时它不影响延伸杆406的六边形孔428。在延伸杆406的壁中有两个定位螺丝孔422，这两个定位螺丝孔彼此相互对齐。将促动器412与延伸杆406放在一起，使得定位螺丝孔422与定位螺丝416共轴地延伸。这允许将定位螺丝拧紧驱动器(如图10和图17的扭矩限制驱动器488)的阳六角头490插入定位螺丝416的六边形孔。当把扭矩限制驱动器488拧紧并在其设定控制扭矩下渐进时，定位螺丝416的另一端(是带螺纹的或者是非螺纹挂钩)插入相对的定位螺丝孔422，因而将促动器412牢固地固定在延伸杆406上。将定位螺丝孔422的尺寸设计成允许阳六角头490顺利地通过，但是，定位螺丝416的非螺纹挂钩非常轻微地通过，从而实现在植入期间不能轻易松开的静态连接。若需要，可将骨水泥放置在定位螺丝孔422的圆环中，甚至进一步粘合定位螺丝416。此外，可在定位螺丝头后面，将第二螺杆拧紧入定位螺丝416最初所嵌套的内螺纹中。此第二螺杆的头将给定位螺丝416的剪切断裂增加附加的阻力。此外，可以拧紧第二螺杆，使得它挤进定位螺丝416中，因而使定位螺丝416的扭松不太可能发生。可采用任何非圆形截面来代替六边形截面，例如正方形或椭圆形的截面。
近端锁定螺杆418插入穿过延伸杆406中的锁定螺杆孔430。延伸杆406可以是直型的或者可以具有特定的曲部432，例如，用于与股骨或胫骨的近端匹配。可以理解的是，模块化布置允许将促动器412附接到具有不同的长度、曲率(包括直型)、直径、孔直径和成角的许多不同型号延伸杆406中的一个。第一消毒托盘402可包括许多这些不同的延伸杆406，可以适当地选择延伸杆406并且将其附接到促动器412。因为促动器412是以无菌形式提供的，所以此布置也是理想的，因为仅需提供一个单一型号。然而，若需要，可存在数种型号的促动器，例如，不同的直径(10.5厘米、12.0厘米、9厘米、7.5厘米)或者不同的远端螺杆孔直径、构造或成角。可以获得用于大量患者以及不同骨骼类型和尺寸的优选构造，且具有最小数量的无菌促动器模型。
转向图15，图中示出了近端钻导件434并且被构造成附接到模块化髓内延长装置410，用以使其插入内骨髓管、在骨骼中的钻孔以及将近端锁定螺杆418附接到骨骼简单化。近端钻导件434包括附接到连接管446的延伸臂436，锁定杆448插入连接管446。锁定杆448具有在近端的锁定旋钮450和在远端的外螺纹452。为了将近端钻导件434暂时地附接到模块化髓内延长装置410，而将近端钻导件434的锁定突片454插入延伸杆406的锁定槽424中并且使锁定旋钮450旋转，从而使锁定杆448的外螺纹452拧入延伸杆406的内螺纹426。在此步骤之前，利用旋钮440将钻导件延伸部438附接到延伸臂436。在将骨骼的骨髓管扩孔至略大于模块化髓内延长装置410的外径的直径(例如11毫米)后，将模块化髓内延长装置410的远端插入骨髓管，并且用锤来锤打锁定旋钮450的平近端表面，从而允许将模块化髓内延长装置410插到正确的深度。尺寸X足以使大股骨或臀部通过(在最差的情况下，是应用于股骨)。例如，以8至10厘米为适宜。一旦模块化髓内延长装置410被置于骨髓管内适当位置处，则使近端钻导件434保留为附接状态并且将导向套442穿过孔456、458、460、462中的一个孔而放置在位并滑动使得远端443到达患者的皮肤。将钻导件延伸部438、延伸臂436以及孔456、458、460、462的尺寸和方向设计成，使得导向套442定位于准确角度，从而使螺杆的钻孔和经过延伸杆406的紧螺杆孔430并且经过骨骼的放置成为可能。切开患者的皮肤并经过手术切口放置钻套444，并且锥形顶端445穿过组织并且到达被钻孔的骨骼。例如，可将钻头和锁定螺杆向下插入钻套444，或者可替换地，将钻头向下插入钻套444，然后在钻孔结束后拆除钻套444并将近端锁定螺杆418向下插入导向套442。替代的导向套464和钻套466可以穿过孔460和462放置，如图10中所示。
转向图16，图中示出了拆除工具468。在牵引期和骨痂硬化期结束后使用拆除工具468。为了将模块化髓内延长装置410从骨髓管中移除，而切开皮肤并将骨骼暴露在近端和远端锁定螺杆418、420的位置以及模块化髓内延长装置410的近端。通过插入啮合顶端476和将外螺纹474拧入内螺纹426(固定在锁定旋钮472上)，而使拆除杆470连接到模块化髓内延长装置410的延伸杆406的内螺纹426。锁定旋钮472包含内螺纹478，内螺纹487使拆除延伸部480的外螺纹486的附接成为可能，拆除延伸部480具有作用旋钮482和拆除锤484。利用枢转基座479的枢转轴477将外螺纹486耦接到拆除延伸部480。通过抓紧作用旋钮482并其旋转，而将外螺纹486固定至内螺纹478。在拆除模块化髓内延长装置410之前，将近端和远端锁定螺杆418、420拆除。可利用锁定螺杆驱动器498将锁定螺杆418、420拆除(图10和图20)，锁定螺杆驱动器498具有与锁定螺杆418、420的近端啮合的阳六角头顶端497。螺杆捕获杆500(图10和图20)向下插入锁定螺杆驱动器498的中心并且具有外螺纹顶端501。在经过锁定螺杆418、420中的凹型六角头513的更深部分(图21A和图21B)是内螺纹511。螺杆捕获杆500的外螺纹顶端501拧入锁定螺杆418、420的内螺纹511，并利用螺杆捕获杆500的拧紧手柄503将其拧紧，拧紧手柄503位于锁定螺杆驱动器498的手柄端509，以便一旦从骨骼拆除锁定螺杆418、420，它们任然固定在锁定螺杆驱动器498，并且将不变成过早地转移。例如，锁定螺杆418、420将不会丢失或者掉落入患者体内。现在，可通过握住拆除锤484并且在方向(D)上使其快速移动以便锤撞击面485击打旋钮撞击面483，将模块化髓内延长装置410从骨髓管拆除。进行该操作，直到模块化髓内延长装置410被完全拆除。应当指出的是，图15的近端钻导件434的锁定旋钮450也具有内螺纹(未图示)，使得在插入模块化髓内延长装置410期间，如果出于任何原因期望将该装置拆除，拆除工具468的外螺纹486可附接到锁定旋钮450的内螺纹，并且可使用拆除锤484作用于该作用旋钮482，以拆除模块化髓内延长装置410。
图17的扭矩限制驱动器488包括手柄496和轴492，轴492具有连接手柄496与轴492的扭矩专用棘轮494。阳六角头顶端490嵌入定位螺丝416的六边形孔、或者甚至嵌入锁定螺杆418、420的内六角头513。用于定位螺丝416示例性的棘轮扭矩为9英寸-磅(1.0牛顿-米)，示例性六角头的尺寸为1/16”(1.59毫米)。
图18以剖视图形式示出了图11的促动器412。在牵拉轴413中可见远端螺杆孔415。图中显示牵拉轴413处于相对于壳体312的完全延伸位置。腔体337已打开至其最大长度。在此实施例中，牵拉轴413具有纯圆柱形表面，并且利用两个O型圈密封件502动态地密封到壳体312。O型圈密封件502可用硅酮、EPDM或者其他橡胶材料制成，并且可用硅油涂布以增加润滑性。在壳体312的内壁上存在4个轴向延伸的槽326。在牵拉轴413端部的突片504嵌入这些槽326，以防止牵拉轴413能够相对于壳体312旋转。壳体312焊接到磁体壳体328，磁体壳体328焊接到六边形凸型轮毂414。六边形凸型轮毂414上的定位螺丝416用于将促动器412附接到延伸杆406。利用环氧树脂封闭圆柱形永久磁体334，置于具有端销360的磁体盒358内。端销360插入穿过径向轴承332，从而使其能够在低摩擦情况下旋转。当利用外部磁体使磁体334旋转时，第一行星齿轮组354、第二行星齿轮组356和第三行星齿轮组357能够实现64∶1(4×4×4)的总减速。各齿轮组能够实现4∶1的减速。利用锁定销342将行星齿轮输出轴344附接到导螺杆336，并且利用圆柱形锁定销保持器348固定锁定销342。推力轴承338与壳体支台或唇部352和磁体壳体支台或唇部350毗邻(推力轴承338夹在壳体支台或唇部352与磁体壳体支台或唇部350之间)。因此，推力轴承338以拉紧状态毗邻壳体支台或唇部352并且以压缩状态毗邻磁体壳体支台或唇部350。应当指出的是，该夹层布置允许在推力轴承338与壳体支台或唇部352和磁体壳体支台或唇部350之间存在部分边坡(slop)或游隙。导螺杆336与螺母340啮合，螺母340固定在牵拉轴413内。利用本实施例的64∶1齿轮减速，利用在磁力机头178与髓内延长装置110之间的间隙(图19中的G)为2英寸(5.08厘米)，始终获得大于300磅(1334牛顿)的牵引力。这对于牵拉大范围的典型患者而言是足够了。
应当指出的是，尽管所给出的髓内延长装置的实施例是用在优先方向(远端相对于近端)，但这些实施例中的任意实施例可用于指向远端或近端的牵拉轴。此外，本发明也可应用于不位于内骨髓管内而位于骨骼外部的可牵拉骨板。
也可采用以上所示方案以外的替代延长方案。例如，一种替代方案包括，有目的地过分延长(以进一步刺激生长)接着是部分回缩(以使疼痛最小化)。例如，4个每天0.25毫米延长期各自可由0.35毫米的延长接着0.10毫米的回缩所组成。
附件408的材料是医用级不锈钢，但可根据期望的重量和所需尺寸而采用不同密度的其他材料。髓内延长装置的大部分构件优选地是钛或钛合金，但是部分的内部构件可由不锈钢制成。
虽然已揭示并描述了本发明的实施例，但在不背离本发明范围的情况下可做各种修改。作为一个实例，本文中所描述的装置可用来延长或改变一些其他骨骼(如下颌骨或者颅骨)。因此，除了受到所附权利要求及其等同物限制之外，本发明不应受到限制。

Claims (31)

1.一种延长装置，被构造成放置在具有第一分离段和第二分离段的骨骼内或者穿越所述骨骼，所述延长装置包括：
壳体，被构造成附接至所述第一分离骨骼段和第二分离骨骼段之一；
牵拉轴，具有沿其长度的内腔，并且被构造成附接至所述第一分离骨骼段和第二分离骨骼段中的另一骨骼段；
永久磁体，被构造成相对于所述壳体旋转并且具有至少两个极，所述永久磁体操作地耦接至导螺杆，所述导螺杆与所述牵拉轴的内腔的螺纹部分接合；以及
推力轴承，设置在所述壳体内并且介于所述导螺杆与所述永久磁体之间，所述推力轴承夹在所述壳体中的第一支台与第二支台之间。
2.根据权利要求1所述的延长装置，其中，所述永久磁体在第一方向上旋转多圈，使得所述导螺杆被置于压缩状态下并且使得所述推力轴承趋向于沿第一轴向方向移动或实际上沿所述第一轴向方向移动，并接触所述第一支台，并且其中，所述永久磁体在第二方向上旋转多圈，使得所述导螺杆被置于拉紧状态下并且使得所述推力轴承趋向于沿与所述第一轴向方向相反的第二轴向方向移动或实际上沿所述第二轴向方向移动，并且接触所述第二支台。
3.根据权利要求1所述的延长装置，进一步包括布置在所述永久磁体与所述导螺杆之间的多个中间齿轮。
4.根据权利要求3所述的延长装置，进一步包括固定至所述多个齿轮中的一个齿轮的输出轴的导螺杆联接器，其中，所述导螺杆固定至所述联接器。
5.根据权利要求4所述的延长装置，其中，利用锁定销将所述导螺杆固定至所述联接器。
6.根据权利要求1所述的延长装置，其中，所述牵拉轴包括位于其外表面上的多个第一纵向槽，并且所述壳体的内表面包括多个第二纵向槽，并且其中，包括被构造成在所述第一纵向槽和第二纵向槽内滚动的多个球体的球笼介于所述牵拉轴与所述壳体之间。
7.根据权利要求1所述的延长装置，进一步包括包含至少一个可旋转永久磁体的外部调节装置。
8.根据权利要求7所述的延长装置，其中，所述外部调节装置包括两个可旋转永久磁体。
9.一种延长装置，被构造成置于具有第一分离段和第二分离段的骨骼的内骨髓管内，所述延长装置包括：
壳体，被构造成附接至所述第一分离骨骼段和第二分离骨骼段之一；
牵拉轴，具有沿其长度的内腔，并且被构造成附接至所述第一分离骨骼段和第二分离骨骼段中的另一骨骼段；
永久磁体，设置在所述壳体内，并且构造成用于旋转并具有至少两个极；以及
行星齿轮组，包括多个齿轮，其中，所述齿轮中的一个齿轮操作地耦接至所述永久磁体并被构造成传递扭矩，并且其中，所述多个齿轮中的另一个齿轮终止于操作地耦接至导螺杆的输出轴，所述导螺杆与所述牵拉轴的内腔的螺纹部分接合。
10.根据权利要求9所述的延长装置，进一步包括布置在所述壳体内的推力轴承，其中，所述输出轴延伸穿过所述推力轴承。
11.根据权利要求10所述的延长装置，其中，所述推力轴承夹在布置在所述壳体的内表面上的近端支台与远端支台之间。
12.根据权利要求9所述的延长装置，进一步包括包含至少一个可旋转永久磁体的外部调节装置。
13.根据权利要求12所述的延长装置，其中，所述外部调节装置包括两个可旋转永久磁体。
14.一种延长系统，构造成放置在骨骼的内骨髓管内，所述延长系统包括：
促动器，包括包含可旋转永久磁体和可移动牵拉轴的壳体，所述可移动牵拉轴相对于所述壳体可伸缩地安装，所述可移动牵拉轴经导螺杆操作地耦接至所述可旋转永久磁体，其中，所述牵拉轴的远端被构造成附接到所述骨骼的第一区，并且其中，所述促动器的近端包括几何成型的凸型轮毂；以及
延伸杆，在其一端具有几何成型的凹型轮毂，所述凹型轮毂被构造成固定至设置在所述促动器上的几何成型的凸型轮毂，其中，所述延伸杆的相对端被构造成附接到所述骨骼的第二区。
15.根据权利要求14所述的延长系统，其中，所述几何成型的凸型轮毂和所述几何成型的凹型轮毂均为多边形的形状。
16.根据权利要求14所述的延长系统，其中，利用定位螺丝将所述促动器与所述延伸杆相互固定。
17.根据权利要求14所述的延长系统，其中，所述延伸杆在其与所述几何成型的轮毂相对的一端包括内螺纹部分。
18.根据权利要求17所述的延长系统，进一步包括被构造成与所述内螺纹部分接合的一个或多个工作件。
19.根据权利要求14所述的延长系统，其中，所述延伸杆在其与所述几何成型的轮毂相对的一端包括一个接收部，所述接收部被构造成与一个或多个工作件接合。
20.根据权利要求16所述的延长系统，其中，所述定位螺丝至少部分地嵌套在布置于所述促动器上的所述几何成型的凸型轮毂内。
21.一种延长系统，构造成置于骨骼的内骨髓管内，所述延长系统包括：
促动器，包括包含可旋转永久磁体和可移动牵拉轴的壳体，所述可移动牵拉轴相对于所述壳体可伸缩地安装，所述可移动牵拉轴经导螺杆操作地耦接至所述可旋转永久磁体，其中，所述牵拉轴的远端被构造成附接到所述骨骼的第一区，并且其中，所述促动器的近端包括几何成型的凹型轮毂；以及
延伸杆，在其一端具有几何成型的凸型轮毂，所述凸型轮毂被构造成固定至布置在所述促动器上的几何成型的凹型轮毂，其中，所述延伸杆的相对端被构造成附接到所述骨骼的第二区。
22.根据权利要求21所述的延长系统，其中，利用定位螺丝将所述促动器与所述延伸杆相互固定。
23.根据权利要求22所述的延长系统，其中，所述定位螺丝至少部分地嵌套在布置于所述延伸杆上的所述几何成型的凸型轮毂内。
24.一种成套组件，包括根据权利要求14所述的促动器和多个不同的延伸杆。
25.一种成套组件，包括根据权利要求21所述的促动器和多个不同的延伸杆。
26.一种用于调节可调节植入物的外部调节装置，包括：
电源；
控制模块；
手持装置，包括至少一个永久磁体；
其中，所述手持装置被构造成放置在患者肢体的第一侧上；并且
其中，所述至少一个永久磁体被构造成，转动位于可调节植入物内的圆柱形磁体；并且
其中，所述控制模块被构造成，限制位于所述可调节植入物内的圆柱形磁体的转数。
27.根据权利要求26所述的外部调节装置，其中，利用安全码对所述控制模块的访问加以限制。
28.根据权利要求26所述的外部调节装置，其中，所述控制模块被构造成，监控所述手持装置的至少一个永久磁体或者位于所述可调节植入物内的所述圆柱形磁体中的一个或两个的移动。
29.根据权利要求28所述的外部调节装置，其中，所述控制模块被构造成，以60RPM或以下的转速旋转所述至少一个永久磁体。
30.根据权利要求26所述的外部调节装置，其中，所述控制模块被构造成，以使得患者的组织和体液的电流密度维持在0.04安培/平方米或以下的转速来转动所述至少一个永久磁体。
31.根据权利要求26所述的外部调节装置，其中，所述控制模块被构造成，以使得患者的组织和体液的磁场强度维持在2.0特斯拉或以下的转速来旋转至少一个永久磁体。
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CN113412090A (zh) * 2019-02-08 2021-09-17 诺威适骨科专科公司 外部调节装置
CN110584841A (zh) * 2019-09-30 2019-12-20 北京爱康宜诚医疗器材有限公司 可延长假体
CN110584841B (zh) * 2019-09-30 2024-04-12 北京爱康宜诚医疗器材有限公司 可延长假体
CN113558740A (zh) * 2021-08-04 2021-10-29 西安市红会医院 一种椎体成型用骨水泥自搅拌用推送器
CN116919556A (zh) * 2023-08-03 2023-10-24 上海康定医疗器械有限公司 一种骨延长髓内钉装置及电磁髓内肢体重建系统

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