CN105473085A - 用于将植入件插入到骨中的髓内植入件、系统与方法 - Google Patents
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Abstract
通过本发明提供了用于布置到骨系统内的髓内植入件、系统、与方法。此植入件包括具有布置在本体的纵轴线周围的至少一对梁的本体。梁每个都固定到本体并且每个都具有端部。一对梁中的一个的端部可释放地联接到此对梁的另一个。此梁各自都在(i)用于将梁插入到相应骨中的联接与偏置位置，与(ii)用于夹持骨的去联接位置之间可偏转。在去联接位置中的各对梁都布置为与骨压紧地接合。
Description
技术领域
公开的设备、系统与方法涉及植入件，并且更具体地说涉及用于安装在附器中以便治疗包括锤状趾的多种骨骼疾病的植入件。
背景技术
锤状趾是趾部的变形，其影响邻近近端趾间(PIP)关节的骨的对准。锤状趾可能造成疼痛并且可能导致行走或者穿鞋困难。锤状趾通常可能导致足部上的开放性溃疡或伤口。在一些情形中，外科手术可能需要通过融合PIP关节与远端趾间(DIP)关节中的一个或两个来矫正变形。
最通常的矫正外科手术包括将销钉或杆布置在足部的远端趾骨、中间趾骨、以及近端趾骨中，以使PIP与DIP关节融合在一起。销钉或杆在趾尖处在身体外部被切割。塑料球或聚合物球布置在杆的暴露端上方，其保持在患者的足部中直到PIP和/或DIP关节在大约6到12周融合。此传统治疗具有几个缺点，诸如当杆或销钉在适当位置时妨碍患者穿闭合趾部的鞋，并且塑料或聚合物球由于其从趾尖延伸可能挂住床单或者其它物体，因此导致患者极其疼痛。
另一个传统植入件包括布置在患者足部的相邻骨内的一对螺纹件。然后植入件通过凸凹连接机构联接到彼此，这很难在原位安装并且具有分离的趋势。
又一种传统植入件具有包括椭圆形头部以及一对初始压缩的支脚的本体。此植入件由镍钛诺形成并且在准备安装以前被冷藏。当安装时，由于植入件的温度升高植入件的头部与支脚膨胀，以在周围骨上提供向外的作用力。然而，温度敏感材料可能导致植入件在安装以前展开或膨胀，这要求使用新的植入件。
因此，用于治疗锤状趾与骨骼系统的其它疾病的改进的髓内植入件是期望的，其提供了跨越关节的主动压紧并且此后保持压紧以便极大地增加融合速率。植入件应该是可插入的，使得对DIP关节干扰最小，同时使在PIP关节处的压紧与固定最佳。此改进的植入件可以在锤状趾外科手术中发现功效。
发明内容
提供了一种髓内植入件，其包括包括本体，布置在本体的纵轴线周围的至少一对从所述本体的相对端突出。梁各自都固定或悬臂到本体并且各自都具有端部。一对梁中的一个的端部可释放地联接到此对梁的另一个梁。此梁各自都在(i)用于将梁插入到相应骨中的联接与偏置位置，与(ii)用于夹持骨的未联接位置之间可偏转。在去联接位置中的各对梁都布置为与骨压紧地接合。
此外，设置一种髓内件，此髓内件包括本体，布置在本体的纵轴线周围的一对梁从所述本体的各相对端突出。梁各自都固定到本体并且各自都具有带有孔的联接闩，使得一对梁中的每个的联接闩都可以通过可移除联接杆可释放地联接到此对梁的另一个梁。通过此种方式，每对梁都在以下位置之间可移动：(i)联接与偏置位置，在所述位置中联接杆定位在各闩的各孔中使得此植入件可以插入到相应骨中，以及(i)用于内部地夹紧相应骨的去联接位置。在去联接位置中的各对梁都远离本体的纵轴线偏离，使得当布置在去联接位置中时，每个梁的外表面都与相应骨形成压紧接合。
在其它实施方式中，设置一种髓内植入件，其包括本体，此本体具有布置在本体的纵轴线周围的一对梁从其突出的端部。每个梁都固定到本体并且各自都具有端部，使得梁中的一个的端部可释放地可联接到此对梁中的另一个梁。此梁每个都在(i)用于将梁插入到相应骨中的联接与偏置位置，与(ii)用于夹持相应骨的去联接位置之间可偏转。处于去联接位置中的此对梁布置为使得与相应骨形成压紧接合。
提供了一种髓内植入件系统，其包括克氏针与植入件，所述植入件包括本体，布置在本体的纵轴线周围的至少一对梁从所述本体的相对端突出。梁各自都固定到本体并且各自都具有带有孔的联接闩，使得一对梁中的每个的联接闩都可以通过克氏针可释放地联接到此对梁的另一个梁。通过此种方式，此对梁中的每个都在以下位置之间可移动：(i)联接与偏置位置，在所述位置中克氏针定位在每个闩的各孔中，使得植入件可以插入到相应骨中，以及(ii)去联接位置，在所述位置中克氏针从每个闩的各孔中移除，使得各对梁远离本体的纵轴线偏离。当布置在去联接位置中时，每个偏离梁的外表面适于形成与相应骨的压紧接合。
提供了一种用于在骨内植入设备的方法，其包括打开与清创目标骨系统，并且然后通过目标骨系统扩孔管道的步骤。提供了克氏线与植入件，其中此植入件包括包括本体，布置在本体的纵轴线周围的至少一对梁从所述本体的相对端突出。每个梁都固定到本体并且每个梁都具有带有孔的联接闩。每个梁的闩都通过将克氏针插入到闩孔中而可释放地联接到彼此，由此可释放地偏置梁。植入件与克氏针插入到管道中，在管道中克氏针与去联接并且将克氏针从闩移除，由此使梁从它们偏置状态去联接与释放，从而使得每个梁的一部分都可以与限定管道的周围骨的表面接合。
附图说明
通过下面对结合附图被一起考虑的本发明的优选实施方式的详细的描述，将会使本发明的这些与其它特征和优点更完全地公开或使得明显，其中相同的附图标记表示相同的部件并且此外其中：
图1是根据本发明的一个实施方式形成的髓内植入件的立体图；
图2是图1示出的植入件的俯视平面图；
图3是图1和图2中示出的植入件以及联接到植入件的克氏针的俯视平面图；
图4是部分地以阴影示出由于去联接弯曲的梁长度的改变的俯视平面图；
图5是安装有克氏针并且为了清楚地描述移除软组织的远端趾骨、中间趾骨、与近端趾骨的立体图；
图5A是不安装有克氏针并且为了清楚地描述移除软组织的远端趾骨、中间趾骨、与近端趾骨的其它立体图；
图6是图5和图5A中示出的远端趾骨、中间趾骨、与近端趾骨的侧视图；
图7是远端趾骨、中间趾骨与近端趾骨的侧视图，根据本发明的一个实施方式形成的植入件安装在中间趾骨的近端，并且为了清楚描述移除了软组织。
图8是示出就在移除克氏针以前完全地安装在近端趾骨与中间趾骨之间的植入件的俯视平面图；
图9是示出完全安装在近端趾骨与中间趾骨之间的植入件的俯视平面图，使得克氏针从近端成对梁与远端成对梁移除与去联接，并且示出了植入件完全地安装在骨内；
图6A是示出根据安装的另选方法的植入设备与系统的初始插入的远端趾骨与中间趾骨的俯视平面图；
图7A是与图6A类似的俯视平面图，其示出了植入系统通过在骨内扩孔的管道的植入系统的进一步进展；
图8A是与图6A和图7A类似的俯视平面图，示出了克氏针从远端成对梁部分地移除与去联接，并且示出了梁抵靠骨的内表面的压紧接合；
图9A是与图6A、图7A和图8A类似的俯视平面图，其示出了完全地安装的植入件，使得克氏针从近端成对梁移除与去联接，并且示出了完全安装在骨内的植入件；
图10是具有通过中心管道重新安装以使相邻关节(θ)稳定的克氏针的图11和图12中示出的植入件的立体图；
图11是克氏针移除的图12中示出的植入件的其它立体图；
图12是根据本发明形成的植入件的另选实施方式的立体图；
图13是部分阴影地示出安装并连接到单对梁的克氏针的本发明的其它另选实施方式的俯视平面图；
图14是图13中示出的植入件但是克氏针从梁移除与去联接的俯视平面图；
图15是与图14类似的俯视图，示出了在与植入件联接以前的克氏针；
图16是图15中示出的植入件的从反向侧面的仰视平面图，以便显露形成在植入件中以便容纳与联接克氏针的凹槽或通道；
图17是部分地以阴影示出与图15-图16的植入件联接的克氏针的俯视平面图；
图18是根据本发明形成的植入件的另一个实施方式；
图19示出了与图18类似的横截面视图，但是示出了联接到植入件的梁的克氏针；
图20是根据本发明形成的植入件的另一个实施方式的端视图；
图21是图20中示出的其它实施方式的侧视图；
图22是沿着图21的线22-22所取的横截面视图；
图23是示出具有弯曲横截面轮廓的植入件的本发明的其它实施方式的立体图；
图24是本发明的成角度植入件实施方式的侧视图；
图25是图24中示出的本发明的成角度的实施方式的俯视平面图；
图26是图24和图25中示出的植入件的实施方式的立体图的端部；
图27是沿着图24-图26中示出的成角度实施方式的线27-27所取得横截面视图；
图28是示出在植入件的本体上对角地布置的一对梁的植入件的又一个实施方式的俯视平面图；
图29是与图28类似的俯视图，示出了根据本发明联接到克氏线的植入件；
图30是示出在植入件的本体的相同侧面上布置的一对梁的植入件的又一个实施方式的俯视图；
图31是与图30类似的俯视图，示出了根据本发明的联接到克氏针的植入件；
图32是示出联接到克氏针的单对梁的根据本发明形成的实施方式的立体图；
图33是沿着图32的线33-33所取的横截面视图；
图34是图32和图33的另选实施方式的立体分解图，示出了在与植入件相互连接以前的治疗设备；
图35是在图34中示出的在相互连接以后的植入件与治疗设备的立体图；
图36是在图35中相互连接的植入件与治疗设备的横截面视图；
图37是与图34类似的立体图，示出了就在与植入件相互连接以前的骨锚定件的形式的治疗设备；
图38是与图35类似的立体图，示出了与植入件相互连接的图37的骨锚定件；
图39是与图36类似的横截面视图，但是示出了与根据本发明形成的植入件相互连接的图37和图38的骨锚定件；
图40是与图34和图37中示出的类似的植入件的分解立体图，示出了就在与植入件相互连接以前的缝线锚定件；
图41是与图40类似的立体图，但是示出了安装在植入件上的缝线锚定件；
图42是沿着图41中的线42-42所取的横截面视图，示出了安装在植入件上的缝线锚定件，使得缝线螺纹通过限定到植入件的本体的中部的导管并且还示出了联接到单对梁的克氏针；
图43是与图42类似的横截面视图，克氏线从单对梁上去联接；
图44是示出与本发明的植入件相互连接的骨螺钉的本发明的其它另选实施方式的立体图；
图45是沿着图44中的线45-45所取的横截面视图，并且还示出了联接到单对梁的克氏线；
图46是与图45类似的横截面视图，但是示出了在从克氏线去联接以后的单对梁；
图47是与图34、图37、图40和图44中示出的植入件类似的植入件的另一个实施方式，示出了安装在植入件内的筒状骨螺钉，使得克氏针定位在筒状骨螺钉内并且联接到单对梁；
图48是沿着图47的线48-48所取的横截面视图；以及
图49是与图48类似但是克氏针被从筒状骨螺钉移除并且从单对梁去联接的横截面视图。
具体实施方式
优选实施方式的描述旨在结合被认为是全部文字描述的一部分的附图进行领会。附图无需按比例绘制并且出于清楚与简洁的目的本发明的一些特征可能以放大比例或者略微示意性形式示出。在说明书中，相对术语，诸如“水平”、“竖直”、“上”、“下”、“顶部”、“底部”及其衍生词(例如，“水平地”、“向下地”、“向上地”等)应该理解为表示如然后描述的或者如在讨论中的附图中示出的方向。这些相对术语是为了方便描述并且通常地不旨在要求特定的方向。包括“向内地”对“向外地”，“纵向地”对“横向”等的术语被相对于彼此或相对于延伸的轴，或者旋转的轴或中心适当地解释。除非明确地另外描述，关于附接等的术语，诸如“联接”与“联接”，表示一种关系，其中结构通过介入结构以及可移动或刚性附接件或关系，直接地或者间接地、临时地或永久地固定或附接到彼此。术语“可操作地联接”是允许相关结构凭借此种关系如所期望的操作这种附接、接合或连接。
参照图1-图4，提供了植入件2，其包括筒状本体4、远端成对悬臂梁6、以及近端成对悬臂梁8。更具体地说，筒状本体4通常包括具有远端14与近端15的细长杠。通常居中地限定沿着纵轴线17通过杠的通孔18，以便在远端14与近端15处限定开口。
远端成对梁6包括相对于彼此以间隔面向关系布置在筒状本体4的远端处的上梁24与下梁26。在本发明的多个实施方式中，成对梁将围绕本体4的纵轴线17对称地布置，以便通常地由轴平分。上梁24固定到筒状本体4的远端14，并且在一些实施方式中，上梁24与筒状本体4一体地形成。一个或多个倒钩30a定位在上梁24的外表面31上，通常横向地跨越外表面31定向。闩板34从上梁24的自由端朝向下梁26向内地延伸。通过闩板34限定孔36a。下梁26固定到筒状本体4的远端14，并且在一些实施方式中，下梁26与筒状本体4一体地形成。一个或多个倒钩30b定位在下梁26的远端外表面32上，通常横向地跨越外表面32定向。闩板38从内下梁26的自由端朝向上梁24与闩板34向内地延伸。通过闩板38限定孔36b。
远端成对梁6在远端14悬臂到筒状本体4，即当在另一端部或者沿着它们长度加载或预加载时，远端成对梁6支撑或夹紧在一端并且能够存储弹性能量。当在正常使用过程中加载远端成对梁6时，它们每个都朝向彼此向内地偏转。有利地，上梁24的长度大于下梁26的长度，使得当偏转到最佳偏置状态时，即梁偏转使得期望数量的弹性能量被存储时，闩板34以重叠邻近关系定位到闩板38，使得孔36a与孔36b彼此是重叠与联通关系(图3-图4)。因此，当加载远端成对梁6时，孔36a和36b通常将以基本上共轴的关系布置到筒状本体4的远端14处的通孔18的开口端。
近端成对梁8包括以在筒状本体4的近端15处以彼此面向关系隔开布置的上梁44与下梁46。上梁44固定到筒状本体4的近端15，并且在一些实施方式中，上梁44与筒状本体4一体地形成。一个或多个倒钩50a定位在上梁44的外表面51上，通常横向地跨越外表面51定向。闩板54从上梁44的自由端朝向下梁46向内地延伸。通过闩板54限定孔56b。下梁46固定到筒状本体4的近端15，并且在一些实施方式中，下梁46与筒状本体4一体地形成。一个或多个倒钩50b定位在下梁46的远端外表面52上，通常横向地跨越外表面52定向。闩板58从内下梁46的自由端朝向上梁44与闩板54向内地延伸。通过闩板58限定孔56a。
与远端成对梁6一样，近端成对梁8也悬臂到筒状本体4但是在近端15处，即当在另一端部或者沿着它们长度加载或预加载时，近端成对梁8支撑或夹紧在一端并且能够存储弹性能量。当在正常使用过程中加载近端成梁8时，它们每个都朝向彼此向内地偏转。有利地，上梁44的长度大于下梁46的长度，使得，当闩板58偏转到最佳偏离状态时，闩板58定位在闩板54附近，使得孔56a与56b彼此重叠。因此，孔56a和56b通常将以基本上共轴的关系布置在筒状本体4的近端15处的通孔18的开口端。
当悬臂的远端成对梁6与近端成对梁8移动到它们相应的第二部分偏置状态中时，它们根据经典梁理论经历所谓的“大偏转”。换句话说，由于梁的加载端朝向彼此向内偏转，因此上梁24、44与下梁26、46的每个的力臂都改变。参照图4，本领域中的技术人员将会理解的是，当远端成对梁6与近端成对梁8布置在它们最佳偏置状态中时，在它们最外部倒钩之间测量的距离β是最大，但是当允许悬臂的远端成对梁6与近端成对梁8移动到它们相应的第二部分偏置状态中时，在最外部倒钩之间测量的距离θ最大。由此，在它们最佳偏置状态与它们第二部分偏置状态之间在梁的长度中存在差值δ。差值δ代表倒钩压紧接合或咬入到限定扩孔管道D的骨中的可获得数量。
植入件2可以由诸如不锈钢或钛的传统的植入金属制造。然而，在几个优选实施方式中，植入件由形状记忆材料(SMA)或诸如镍钛的合金制成以增强固定。此合金的一个实例是由加利福尼亚的门洛帕克的迈瑞公司销售的镍钛诺。植入件优选地地有镍钛诺、生物可兼容的钛和镍的形状记忆金属合金制成。在较高温度(奥氏体阶段)下的金属特性与钛的金属特性类似。可以通过制造过程与适当合金组分的选择来控制植入件将经历形状转换的温度。镍钛诺具有非常地的腐蚀率并且已经用于多种医疗植入件中，例如正畸装置、支架、缝合锚定件等。在动物中的植入件研究已经显示与金属接触的组织中的镍的最小升高；钛的等级与在钛臀部假体附近组织中发现的最低等级相当。在本发明的大部分实施方式中，SMA选择为具有温度变换范围，使得在变形力的影响下植入件经历从奥氏体到应力引起的马氏体的变换。由此，当植入件2的远端梁与近端梁朝向彼此向内地偏转并且然后释放时，它们已经在使得它们自动地试图重新形成它们初始形状的温度下。
参照图5-图9A，如下，植入件2制备为在足部的远端趾骨B、中间趾骨A、近端趾骨C处在矫正手术中使用。加载近端成对梁6，使得它们各自都朝向彼此向内地偏转直到闩板38定位在闩板34附近，使得孔36a与孔36b彼此重叠。同样地，还加载近端成对梁8使得它们各自都朝向彼此向内地偏转直到闩板58定位在闩板54附近，使得孔56a与孔56b彼此重叠。一旦在此布置中，诸如克氏针60的联接杆就插入通过孔56a、56b、通孔18、以及孔36a、孔36b，由此在它们相应最佳偏置状态中联接远端成对梁6与近端成对梁8。在一些实施方式中，克氏线60包括近端部分63，此近端部分63具有比克氏线的远端部分更小的直径，由此在过渡部69处在直径之间限定肩部67。肩部67的尺寸通常设计为与闩板54的外表面接合并且由此防止克氏针60进一步前进到植入件2中超过过渡部69。
植入件2在用于矫正手术的系统与方法中在人类或动物体内的骨中的足部的远端趾骨B、中间趾骨A、以及近端趾骨C或其它地方中使用。PIP关节首先开口与清创并且初始克氏针75(图5)插入通过中间趾骨A的轴并且到趾部的远端以外。然后将初始克氏针75从趾部(图5A和图6)的远端尖端向远端移除。利用扩孔器或类似仪器(未示出)通过PIP关节的远端部分与近端部分限定管道D。管道D沿着先前由克氏针75限定的路径延伸进入到中间趾骨A中一段距离，使得埋头孔肩部71限定在管道D的直径与由克氏针75的先前插入形成的通路之间的过渡部。肩部71的尺寸通常设计为使得与闩板54或34的外表面接合并且由此防止植入件2进一步向远端前进到中间趾骨A中。
一旦已经以上述方式准备外科手术位置，已经联接到克氏针60的植入件2就插入通过扩孔管道D(图7)，使得克氏针60前进通过中间趾骨A与远端趾骨B，使得远端部分63从远端趾骨B的端部向外地突出。通过此种方式，植入件2沿着中间趾骨A的纵轴线向下前进直到限定的远端梁6邻近扩孔管道D(图7)内的肩部71。一旦在此位置中，远端成对梁6的端部就定位在中间趾骨A内的肩部71附近，并且近端成对梁8在中间趾骨A的近端处从管道D的开口端向外突出。接着，通过移动远端趾骨与中间趾骨重新对准与闭合此关节，从而致使近端成对梁8进入近端趾骨C(图8)中的管道D的开口端。在此位置中，近端成对梁8定位在近端趾骨C中的管道D内并且此关节在植入件2周围闭合。
一旦在上述布置中，克氏针60就向远端移动(图9)以便与近端梁8的闩板54和58脱离接合，由此使梁44和46从它们最佳的偏压状态去联接与释放。由此，上梁44与下梁46远离彼此向外地跃出，直到它们相应的倒钩50a和50b与限定扩孔管道D的周围骨的表面接合。由于上梁44与下梁46仍偏转，即继续存储一些弹性能量，但是几何地缩短数量δ。倒钩50a和50b与周围骨的表面压紧地接合，以便“咬”入到骨中，由此增强了植入件2的保持。应该指出的是，近端成对梁8的力臂的相应缩短将主动压紧力施加到PIP关节的铰接表面。克氏针60继续从植入件2去联接并且收回，通过筒状本体4的通孔18直到远端70滑动经过远端成对梁6的闩板34和38中的通孔36a、36b，以使克氏针60与植入件2(图9A)完全地去联接。因此，上梁24与下梁26远离彼此并且远离它们最佳的偏置状态向外地跃出到部分偏置状态中，在所述状态中远端成对梁6与限定扩孔管道D的骨的表面接合。再次在这里，本领域中的技术人员将会理解的是，由于悬臂的远端成对梁6移动到它们第二部分偏置状态中，因此它们也将会缩短。此几何作用将主动压紧力施加到PIP关节的铰接表面，同时近端成对梁8保持皮质固定在关节的任一侧上。有利地，通过上梁24与下梁26的移动到它们部分偏置状态中的向外的力，致使倒钩30a与倒钩30b咬入限定扩孔管道D的骨中。钩30a与30b的到骨中的咬合极大地增强了由近端成对梁8施加的压紧载荷。
在图6A-图9A中示出的另选实施方式中，一旦如上面这里描述的准备外科手术位置，已经联接到克氏针60的植入件2就插入通过扩孔管道D(图6A)。通过此种方式，植入件2沿着中间趾骨A的纵轴线前进直到限定的近端梁8邻近近端趾骨C(图7A)内的扩孔管道D的端部。一旦在适当位置中，克氏针60就向远端移动(图8A)，以使远端部分63与近端梁8的闩板34和38脱离接合，由此使梁24和26从它们最佳的偏压状态去联接与释放。因此，上梁24与下梁26远离彼此向外地跃出，直到它们相应的倒钩30a和30b与限定扩孔管道D的周围骨的表面接合。由于上梁24与下梁26仍偏置，即继续存储一些弹性能量，但是几何地缩短数量δ，因此倒钩30a和30b与周围骨的表面压紧地接合以便“咬”入到骨中，由此增强了植入件2的保持。应该指出的是近端成对梁8的力臂的相应缩短将主动压紧力施加到PIP关节的铰接表面，同时远端成对梁6经由倒钩30a和30b保持皮质固定。
在近端成对梁8完全地定位在近端趾骨C内的情况下，关节被轴向地压紧以使近端成对梁8完全地定位在扩孔管道D(图8A)内。克氏针60继续从植入件2去联接并且收回，通过筒状本体4的通孔18直到近端70滑动经过远端成对梁6的闩板54和58中的通孔56a、56b，以使克氏针60与远端成对梁6(图9A)完全地去联接。因此，远端成对梁6远离彼此并且远离它们最佳的偏置状态向外地跃出到其中远端成对梁6与限定扩孔管道D的骨的表面接合的部分偏置状态中。再次在这里，本领域中的技术人员将会理解的是，由于悬臂的远端成对梁6移动到它们第二部分偏置状态中，因此它们也将会缩短它们的长度。此几何作用将主动压紧力施加到PIP关节的铰接表面，同时远端成对梁8保持皮质固定。有利地，定位在上梁44的外表面51上的倒钩50a与定位在下梁46的外表面46上的倒钩50b通过移动到它们部分偏置状态中的上梁44与下梁46的向外的力被致使咬入限定扩孔管道D的骨中。倒钩30a、30b、50a和50b的到在关节两侧处的内骨表面中的咬合，与近端梁8与远端梁6的几何缩短联合，极大地增加了跨越PIP关节施加的压紧载荷。
这里公开的实施方式的细节上的多种改变将是显而易见的，并且本领域中的技术人员参照上面的描述可以实现。例如，并且参照图10-图12，设有植入件82，其包括本体84、悬臂远端成对梁86、以及悬臂近端成对梁88。如与植入件2的筒状本体4不同，本体84限定具有远端94与近端95的细长通道或凹槽90。远端成对梁86a、86b以彼此间隔面向关系布置在本体84的远端94处。每个梁86a、86b都固定到远端94，并且在一些实施方式中，每个梁86a、86b都与本体84一体地形成。在各远端梁86a、86b的外表面上定位一个或多个倒钩96。端部开口凹槽90延伸通过本体84的内部。端部开口凹槽100a限定为通过远端梁86b(图10)的内部远端部分的通道，其尺寸设计为可滑动地容纳克氏针60a的锋利部分。远端成对梁86a、86b悬臂到本体84，即支撑或夹紧在一端处，并且当在其它端部或者沿着它们长度加载或预先加载时能够存储弹性能量。当在正常使用过程中联接与加载远端成对梁86a、86b时，它们各自都朝向彼此向内地偏转。
近端成对梁88a、88b以彼此间隔面向关系布置在本体84的近端95处。在各近端梁88a、88b的外表面上定位一个或多个倒钩96。凹槽100b限定为通过近端梁88a(图10和图11)的内部远端部分的通道，其尺寸设计为可滑动地容纳克氏线60b的圆形部分。与远端成对梁86a、86b一样，近端成对梁88a、88b也悬臂到筒状本体84但是在近端95处，即支撑或夹紧在一端处，并且当加载或预先加载在另一端处或者沿着它们长度时能够存储弹性能量。当在正常使用过程中联接与加载近端成对梁88a、88b时，它们每个都朝向彼此向内地偏转。
植入件82制备为以与植入件2大致相同的方式在足部的远端趾骨B、中间趾骨A、近端趾骨C处在矫正手术中使用。更具体地说，远端成对梁86a、86b加载为使得它们各自都朝向彼此向内地偏转，使得本体84的端部开口凹槽90与凹槽100a以彼此基本上共轴的关系布置。同样地，近端成对梁88a、88b还加载为使得它们各自都朝向彼此向内地偏转，使得本体84的端部开口凹槽90与凹槽100b以彼此基本上共轴的关系布置。一旦在此布置中，克氏线60a就插入通过凹槽100a、端部开口凹槽90、以及凹槽100b，由此在它们相应的最佳偏置状态中联接远端成对梁86a、86b与近端成对梁88a、88b。
与植入件2一样，克氏针60的移除与去联接致使远端成对梁86a、86b与近端成对梁88a、88b向外地并且远离彼此跃出，由此缩短它们的长度，从而将主动压紧力施加到PIP关节的铰接表面。有利地，由于继续存储在各梁中的弹性能量，因此通过远端成对梁86a、86b与近端成对梁88a、88b的移动到他们不放偏置状态中的力，致使倒钩96压紧地咬入到限定扩孔管道的骨中。倒钩96咬入到骨中极大地增强了由植入件82施加的压紧载荷。在克氏线60完全地去联接以后，当远端成对梁86a、86b与近端成对梁88a、88b向外地并且远离彼此跃出时，具有远端94与近端95的细长通道或凹槽90再次能够滑动地容纳克氏针60。克氏针60的锋利部分60a，例如向近端驱动通过患者趾部的尖端并且通过植入件82的凹槽90的远端94与近端95，以实现外露关节(例如MTP关节)的临时稳定。
根据本发明的一般原理的植入件可以采用多种构造。参照图13-图17，近端梁86a与远端梁88b可以布置在本体84的它们的相应端部上，具有略微较薄或可变的横截面，以便允许将弹性力调节到如对于特定治疗可能需要的预定等级。参照图18-图19，应该理解的是，植入件2可以包括沿着其相应梁26、46的长度定位在任何地方的下闩板38a或58a。如图20-图23中所示，植入件2可以具有任何周边形状。通常，植入件2将具有圆形或椭圆形周边形状以便更好地适于通过钻取的管道D布置。应该指出的是，在植入件2的圆形或椭圆形实施方式的情况下，可以通过一个或多个部分平坦壁110限定孔36a、36b或56a、56b，以便允许闩板中的足够壁厚并且允许与相应形状的克氏针60b接合。此布置允许外科医生相对于限定扩孔管道D的骨表面可旋转地定向植入件2。如图24和图27中所示，植入件112可以形成为在本体4a的中心处或附近弯曲。在这些实施方式中，远端成对梁6或近端成对梁8可以相对于本体4a成角度布置与定向。此外包括镍钛诺的以插入通过弯曲部60c的类似成形的克氏针在植入件112的使用过程中以这里在前面公开的方式联接与去联接。
现在参照图28-图29，提供了一种植入件122，其包括本体124、远端悬臂梁126、以及近端悬臂梁128。本体124限定通孔130并且具有远端134与近端135。近端梁126从本体124的远端纵向向外地突出，同时远端悬臂梁128从本体124的近端纵向向外地突出。一个或多个倒钩136定位在远端134与近端135中每个的外表面上。闩板140从近端悬臂梁126的自由端向内地延伸，并且第二闩板142从远端悬臂梁128的自由端向内地延伸。通过闩板140限定孔146a，并且通过闩板142限定孔146b。悬臂梁124、126悬臂到本体124，即支撑或夹紧在一端处，并且当在另一端处或者沿着它们长度加载或预先加载时悬臂梁124、126能够存储弹性能量。当在正常使用过程中加载悬臂梁124、126时，它们各自都向内地偏转。有利地，悬臂梁124、126布置为使得相对于本体124彼此对角地定位。
植入件122制备为以与植入件2大致相同的方式在足部的远端趾骨B、中间趾骨A、近端趾骨C处在矫正手术中使用。更具体地说，近端悬臂梁126与远端悬臂梁128被加载为使得它们各自都朝向本体124的通孔130的纵轴线向内地偏转，使得闩板140的孔146a与闩板142的孔146b相对于彼此以基本上共轴的关系布置。一旦在此布置中，克氏线60就插入通过孔130、孔146a、以及孔146b，由此在它们相应的最佳偏置状态中联接远端悬臂梁126与近端悬臂梁128。
与其它植入件实施方式一样，克氏针60的去联接致使近端悬臂梁126与远端悬臂梁128向外地并且远离彼此并且远离本体124的通孔130的纵轴线向外地跃出，由此缩短它们的长度，以将主动压紧力施加到PIP关节的铰接表面。有利地，致使倒钩96咬入通过近端悬臂梁126和远端悬臂梁128的当它们移动到它们相应的部分偏置状态中时的缩短的向外力压紧的骨中。倒钩96咬入关节的两侧处的内骨表面中，与近端梁与远端梁的几何缩短结合，极大地增强了通过植入件122跨越关节施加的压紧载荷。参照图30和图31，应该理解的是，植入件122a可以形成具有布置在本体124的相同侧面上而不是如植入件122对角地布置的远端悬臂梁126a与近端悬臂梁128a。
参照图32-图36，提供了植入件150，其包括本体154与单对悬臂梁156以及配合结构，所述配合结构适于经由与限定在本体154中的盲孔151a和151b相互连接将植入件150接合到治疗设备157。更具体地说，单对悬臂梁156包括相对于彼此以间隔面向关系布置在本体154的端部处的上梁160与下梁162。上梁160固定到本体154的端部，并且在一些实施方式中，上梁160与本体154一体地形成。一个或多个倒钩96定位在上梁160的外表面上，通常横向地跨越外表面定向。闩板164从上梁160的自由端朝向下梁162向内地延伸。通过闩板164限定孔166。下梁162固定到本体154的端部，并且在一些实施方式中，下梁162与本体154一体地形成。一个或多个倒钩96定位在下梁162的外表面上，通常横向地跨越外表面定向。闩板168从内下梁162的自由端朝向上梁160与闩板164向内地延伸。通过闩板168限定孔170。悬臂梁160、162悬臂到本体154，即支撑或夹紧在一端处，并且当在另一端处或者沿着它们长度加载或预先加载时悬臂梁160、162能够存储弹性能量。当在正常使用过程中联接与预加载悬臂梁160、162时，它们各自都向内地偏转。
植入件150制备为以与植入件2大致相同的方式在贯穿患者的多个骨科位置处的外科手术中使用。更具体地说，单对梁160、162加载为使得它们各自都朝向彼此向内地偏转，使得孔166、孔170、与盲孔151b相对于彼此以基本共轴关系布置。一旦在此布置中，克氏针60就插入通过孔166、孔170、与盲孔151b，由此在它们相应最佳偏置状态中联接单对梁160、162。与植入件2一样，使克氏针60去联接致使单对梁160、162向外地并且远离彼此跃出，由此缩短了它们的长度，以将主动压紧力施加到PIP关节的铰接表面。有利地，致使倒钩96咬入通过成对梁160、162的当它们移动到它们相应的部分偏置状态中时而缩短的向外力压紧的骨中。倒钩96到骨中的咬合极大地增强了由植入件150施加的压紧载荷。
根据本发明的上述实施方式的一般原理的植入件可以采用多种构造。参照图37-图39，锥形且加肋的锚定件173可以经由柱175与螺纹孔151a之间的螺纹接合联接到本体154。如图40-图43中所示，缝线锚定件178可以以与锥形且加肋的锚定件173类似的方式装配到本体154。孔151a与孔151b可以修改，以便经由导管181(图40-图43)联通，由此允许缝线180离开单对梁160、162附近的植入件150。通常，植入件150将具有圆形或椭圆形周边形状，以便更好地适于通过扩孔管道D定位。如图44和图49中所示，植入件150可以形成为容纳螺钉200或者筒状螺钉210。
尽管已经根据示例性实施方式描述了本发明，但是本发明不限于此。此外，应该广义地理解所附权利要求，以包括本发明的其它变型与实施方式，在不偏离本发明的范围与等效范围的情况下，本领域的技术人员可以做出该其它变型与实施方式。
Claims (42)
1.一种髓内植入件，包括：
本体，布置在所述本体的纵轴线周围的至少一对梁从所述本体的相对端突出，
所述梁各自都固定到所述本体并且具有端部，所述成对梁中的一个的所述端部可释放地联接到所述成对梁的另一个，所述梁各自都能够在(i)用于将所述梁插入到相应骨中的联接与偏置位置和(ii)用于夹紧所述相应骨的去联接位置之间偏转，所述各对梁在所述去联接位置处都布置为与所述相应骨形成压紧接合。
2.根据权利要求1所述的髓内植入件，其中，所述本体限定沿着所述纵轴线的通孔。
3.根据权利要求1所述的髓内植入件，其中，所述本体限定沿着大体平行于所述纵轴线的外表面的通道。
4.根据权利要求1所述的髓内植入件，其中，当将所述梁联接与偏置以便插入到相应骨中时，所述梁各自都朝向所述纵轴线向内地偏转。
5.根据权利要求1所述的髓内植入件，其中，所述梁围绕所述本体的所述纵轴线对称地布置。
6.根据权利要求2或3所述的髓内植入件，其中，所述梁围绕所述本体的所述纵轴线非对称地布置。
7.根据权利要求2或3所述的髓内植入件，其中，所述梁以彼此对角隔开的关系布置在所述本体上。
8.根据权利要求1所述的髓内植入件，其中，所述至少一对梁各自都具有带有孔的联接闩，使得一对梁的每个所述梁的所述联接闩都可以可释放地联接到所述一对梁的另一个梁。
9.根据权利要求8所述的髓内植入件，其中，所述本体限定沿着所述纵轴线的通孔。
10.根据权利要求8所述的髓内植入件，其中，所述本体限定沿着大体平行于所述纵轴线的外表面的通道。
11.根据权利要求8所述的髓内植入件，其中，当将所述梁联接与偏置以插入到相应骨中时，所述梁各自都朝向所述纵轴线向内地偏转。
12.根据权利要求8所述的髓内植入件，其中，所述梁围绕所述本体的所述纵轴线对称地布置。
13.根据权利要求9或10所述的髓内植入件，其中，所述梁围绕所述本体的所述纵轴线非对称地布置。
14.根据权利要求9或10所述的髓内植入件，其中，所述梁以彼此对角隔开的关系布置在所述本体上。
15.根据权利要求1所述的髓内植入件，其中，所述本体构造为连接治疗设备以便通过所述相应骨定位。
16.一种髓内植入件，包括：
本体，布置在所述本体的纵轴线周围的一对梁从所述本体的各个相对端突出，所述梁各自都固定到所述本体并且各自都具有带有孔的联接闩，使得一对梁中的每个所述梁的所述联接闩可以通过可移除联接杆可释放地联接到所述一对梁的另一个梁，从而使所述一对梁中的每个都能够在：(i)联接与偏置位置，其中所述联接杆定位在各闩的每个孔中，使得所述植入件可以插入到相应的骨中，以及(ii)用于内部地夹持所述相应骨的去联接位置之间偏转，在去联接位置中，所述各对梁都远离所述本体的所述纵轴线偏离，其中当布置在所述去联接位置中时，每个梁的外表面都适于与相应骨形成压紧接合。
17.根据权利要求16所述的髓内植入件，其中，所述本体限定沿着所述纵轴线的通孔。
18.根据权利要求16所述的髓内植入件，其中，所述本体限定沿着大体平行于所述纵轴线的外表面的通道。
19.根据权利要求16所述的髓内植入件，其中当将所述梁联接与偏置以插入到相应骨中时，所述梁各自都朝向所述纵轴线向内地偏转。
20.根据权利要求16所述的髓内植入件，其中，所述梁围绕所述本体的所述纵轴线对称地布置。
21.根据权利要求17或18所述的髓内植入件，其中，所述梁围绕所述本体的所述纵轴线非对称地布置。
22.根据权利要求17或18所述的髓内植入件，其中，所述梁以彼此对角隔开的关系布置在所述本体上。
23.根据权利要求16所述的髓内植入件，其中，所述本体构造为连接治疗设备以便通过所述相应骨定位。
24.一种髓内植入件，包括：
具有端部的本体，布置在所述本体的纵轴线周围的一对梁从所述端部突出，所述梁各自都固定到所述本体并且具有端部，一个所述梁的所述端部可释放地联接到所述一对梁的另一个梁，所述梁各自都能够在(i)用于将所述梁插入到相应骨中的联接与偏置位置，与(ii)用于夹紧所述相应骨的去联接位置之间偏转，所述一对梁在所述去联接位置处都布置为与所述相应骨形成压紧接合。
25.根据权利要求24所述的髓内植入件，其中，所述本体限定沿着所述纵轴线的通孔。
26.根据权利要求24所述的髓内植入件，其中，所述本体限定沿着大体平行于所述纵轴线的外表面的通道。
27.根据权利要求24所述的髓内植入件，其中，所述一对梁围绕所述本体的所述纵轴线对称地布置以便平分所述一对梁。
28.根据权利要求24所述的髓内植入件，其中，当将所述梁联接与偏置以插入到相应骨中时，所述梁各自都朝向所述纵轴线向内地偏转。
29.根据权利要求24所述的髓内植入件，其中，所述梁围绕所述本体的所述纵轴线对称地布置。
30.根据权利要求25或26所述的髓内植入件，其中，所述梁围绕所述本体的所述纵轴线非对称地布置。
31.根据权利要求24所述的髓内植入件，其中，所述一对梁各自都具有带有孔的联接闩，使得每个所述梁的所述联接闩都可以可释放地联接到另一个梁。
32.根据权利要求31所述的髓内植入件，其中，所述本体限定沿着所述纵轴线的通孔。
33.根据权利要求31所述的髓内植入件，其中，当将所述梁联接与偏置以插入到相应骨中时，所述梁各自都朝向所述纵轴线向内地偏转。
34.根据权利要求31所述的髓内植入件，其中，所述梁以彼此对角隔开的关系布置在所述本体上。
35.根据权利要求31所述的髓内植入件，其中，所述本体构造为连接治疗设备以便通过所述相应骨定位。
36.根据权利要求24所述髓内植入件，其中，所述本体是筒状的，其中通孔居中地限定，以便在所述本体的远端与近端之间联通。
37.根据权利要求36所述的髓内植入件，其中，所述一对梁包括上梁与下梁，其中闩板从各梁的自由端向内地延伸，且具有通过各闩板限定的中心孔。
38.根据权利要求37所述的髓内植入件，其中，当所述一对梁联接到彼此时，所述下梁的长度小于所述上梁的长度。
39.根据权利要求24所述的髓内植入件，其中，当所述一对梁联接到彼此时同时相对于所述本体成角度定向。
40.一种髓内植入系统，包括：
克氏针：以及
本体，布置在所述本体的纵轴线周围的至少一对梁从所述本体的相对端突出，所述梁各自都固定到所述本体并且各自都具有带有孔的联接闩，使得一对所述梁中的每个的联接闩都可以通过所述克氏针可释放地联接到所述一对梁的另一个梁，从而使得所述一对梁中的每个都能够在以下位置之间移动：(i)联接与偏置位置，在该位置所述克氏针定位在各闩的每个孔中，使得所述植入件可以插入到相应的骨中，以及(ii)去联接位置，在该去联接位置中所述克氏针被从每个闩的各孔移除，使得各对梁远离所述本体的所述纵轴线偏离，其中当布置在所述去联接位置中时每个梁的外表面都适于与所述相应骨形成压紧接合。
41.一种用于将设备植入在骨内的方法，包括；
(a)打开与清创目标骨系统；
(b)形成通过所述目标骨系统的管道；
(c)提供克氏针与植入件，所述植入件包括本体，布置在所述本体的纵轴线周围的至少一对梁从所述本体的相对端突出，其中所述本体限定沿着所述纵轴线的通路，所述梁各自都固定到所述本体并且各自都具有带有孔的联接闩；
(d)通过将所述克氏针插入到所述闩孔中而可释放地联接每个所述梁的所述闩，由此偏置所述梁；
(e)将所述植入件与克氏针插入到所述管道中；
(d)使所述克氏针与所述闩去联接并且将所述克氏针从所述闩移除，由此使所述梁从它们的偏置状态去联接并且释放，使得各梁的一部分与限定所述管道的周围骨的表面接合。
42.一种根据权利要求40所述的用于将设备植入骨内的方法，其中将所述克氏针再次插入到所述本体的所述通路中。
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| US14/179,172 US9545274B2 (en) | 2014-02-12 | 2014-02-12 | Intramedullary implant, system, and method for inserting an implant into a bone |
| US14/179,172 | 2014-02-12 | ||
| PCT/US2014/069337 WO2015122960A1 (en) | 2014-02-12 | 2014-12-09 | Intramedullary implant, system, and method for inserting an implant into a bone |
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| US (1) | US9545274B2 (zh) |
| EP (1) | EP3104794A4 (zh) |
| JP (1) | JP2016539702A (zh) |
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| CN1047025A (zh) * | 1989-04-25 | 1990-11-21 | 佩-英格瓦·布兰尼马克 | 用于支撑手指关节或其它被修复关节的关节机构的固定元件 |
| US20130253515A1 (en) * | 2005-04-14 | 2013-09-26 | Memometal Technologies | Device for osteosyntheses or arthrodeses of two- bone parts, in particular of the hand and / or foot |
| US20100131014A1 (en) * | 2007-03-20 | 2010-05-27 | Memometal Technologies | Osteosynthesis device |
| WO2010029246A1 (fr) * | 2008-09-09 | 2010-03-18 | Memometal Technologies | Implant intramedullaire resorbable entre deux os ou deux fragments osseux |
| US20130131822A1 (en) * | 2011-11-17 | 2013-05-23 | Orthohelix Surgical Designs, Inc. | Hammertoe implant |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112494109A (zh) * | 2020-12-11 | 2021-03-16 | 中国人民解放军陆军特色医学中心 | 一种肿瘤切割装置 |
| CN112494109B (zh) * | 2020-12-11 | 2021-12-21 | 中国人民解放军陆军特色医学中心 | 一种肿瘤切割装置 |
| CN115177346A (zh) * | 2022-07-01 | 2022-10-14 | 无锡市第九人民医院 | 一种便于植入和取出的柱状弹性髓内钉 |
| CN115177346B (zh) * | 2022-07-01 | 2023-11-03 | 无锡市第九人民医院 | 一种便于植入和取出的柱状弹性髓内钉 |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2896949A1 (en) | 2015-08-12 |
| AU2017200339B2 (en) | 2018-10-18 |
| CA2896949C (en) | 2017-06-13 |
| AU2017200339A1 (en) | 2017-02-02 |
| JP2016539702A (ja) | 2016-12-22 |
| WO2015122960A1 (en) | 2015-08-20 |
| EP3104794A1 (en) | 2016-12-21 |
| AU2014331635A1 (en) | 2015-08-27 |
| EP3104794A4 (en) | 2017-09-20 |
| US9545274B2 (en) | 2017-01-17 |
| US20150223848A1 (en) | 2015-08-13 |
| AU2014331635B2 (en) | 2016-10-20 |
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