CN109640889A - 可扩张的角度可调节式关节运动椎间保持架 - Google Patents
可扩张的角度可调节式关节运动椎间保持架 Download PDFInfo
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Abstract
本发明实施方案提供各种椎体间融合间隔件或保持架,以用于在相邻椎骨之间插入。所述可包含关节运动机构,保持架所述关节运动机构允许扩张和角度调节,并且使得上板部件和下板部件能够相对于彼此平滑地滑动。所述保持架可具有第一插入构型,所述第一插入构型的特征在于在所述保持架的插入端中的每个处的减小的尺寸,以有利于插入穿过狭窄的进入通路并插入所述椎间空间中。在所述保持架的第二扩张构型中,所述保持架能够保持适当的椎间盘高度并通过恢复矢状平衡和对齐来稳定所述脊柱。所述椎间保持架能够调节所述脊柱前凸角,并且可在其第二扩张构型中适应较大的脊柱前凸角。此外,这些保持架可促进融合以通过固定所述相邻椎体来进一步増强脊稳定性。
Description
相关申请的交叉引用
本申请要求2016年6月28日提交的美国临时申请No.62/355,619的权益,其以引用方式并入本文。
技术领域
本公开涉及矫形可植入式装置,并且更具体地涉及用于稳定脊柱的可植入式装置。甚至更具体地,本公开涉及可扩张的角度可调节式椎间保持架,椎间保持架包括关节运动机构,关节运动机构允许从具有减小尺寸的第一插入构型扩张至具有扩张尺寸的第二植入构型。椎间保持架被构造成调节和适应脊柱前凸角,尤其是较大的脊柱前凸角,同时恢复脊柱的矢状平衡和对齐。
背景技术
促进融合的椎体间可植入式装置(通常称为保持架或间隔件)的使用是众所周知的用于治疗某些脊柱病症或疾病的护理标准。例如,在一种类型的脊柱病症中,椎间盘由于急性损伤或创伤、椎间盘疾病或仅仅是自然老化过程而恶化或受损。健康的椎间盘起到稳定脊柱并在椎骨之间分配力以及缓冲椎体的作用。因此,弱化或受损的椎间盘导致力失衡以及脊柱的不稳定性,从而导致不适和疼痛。典型的治疗可涉及分别在称为部分或全部椎间盘切除术的过程中手术切除部分或全部患病或受损椎间盘。椎间盘切除术之后通常插入保持架或间隔件来稳定此弱化或受损的脊柱区域。此保持架或间隔件起到减少或抑制被治疗区域中的移动的作用,以避免损伤的进一步发展和/或降低或减轻由损伤或伤害造成的疼痛。此外,这些类型的保持架或间隔件用作机械或结构支架来恢复和保持正常的椎间盘高度,并且在一些情况下,也可促进相邻椎骨之间的骨融合。
然而,这些类型的手术的当前挑战之一是提供给外科医生操纵保持架并将保持架插入待治疗的椎间区域中的非常有限的工作空间。进入椎间空间需要在回缩的相邻血管和组织诸如主动脉、腔静脉、硬膜和神经根周围进行导航,从而留下非常狭窄的路径用于进入。到椎间空间的开口本身也相对小。因此,在不显著破坏周围组织或椎体本身的情况下,对于可插入的保持架的实际尺寸存在物理限制。
进一步使问题复杂化的事实是,椎体不在正常脊柱中彼此平行定位。由于椎体相对于彼此的角度关系,脊柱存在自然弯曲。理想的保持架必须能够适应椎体的此角度关系,否则当在椎间空间内部时,保持架将不能正确地座置。装配不当的保持架应当移位或移出位置,并且随着时间的推移而失效,或更糟的是,进一步损害已经弱化的区域。
因此,期望提供不仅具有机械强度或结构完整性的椎间保持架或间隔件以恢复椎间盘高度或椎体与待治疗的脊柱节段的对齐,而且还被构造成容易地穿过狭窄的进入路径进入椎间空间中,然后适应该空间的角度约束,尤其是对于较大的脊柱前凸角。
发明内容
本公开描述了解决上述挑战并满足期望目标的脊柱可植入式装置。这些脊柱可植入式装置或更具体地为椎间保持架或间隔件被构造成扩张以及角度可调节。保持架可包括通过关节运动扩张或调节机构连接的上板部件和下板部件,所述机构允许保持架根据需要改变尺寸和角度而不费力。在一些实施方案中,保持架可具有第一插入构型,第一插入构型的特征在于在保持架的插入端处的减小的尺寸,以有利于插入穿过狭窄的进入通路并插入椎间空间中。保持架可以以第一减小的尺寸插入,然后一旦植入就扩张到第二扩张尺寸。在它们的第二构型中,保持架能够保持适当的椎间盘高度并通过恢复矢状平衡和对齐来稳定脊柱。可以设想,在一些实施方案中,椎间保持架还可被设计成允许保持架以可自由选择(或无级)的方式扩张以达到其第二扩张构型。椎间保持架被构造成能够调节脊柱前凸角,并且可在其第二扩张构型中适应较大的脊柱前凸角。此外,这些保持架可促进融合以通过固定相邻椎体来进一步増强脊柱稳定性。
另外,可植入式装置可使用选择性激光熔融(SLM)技术(增材制造形式)来制造。这些装置也可通过其他类似的技术制造,诸如3D打印、电子束熔融(EBM)、层沉积和快速制造。利用这些生产技术,可创建一体化的多部件装置,该装置可具有互连和可移动的零件,而不进一步需要外部固定或附接元件来将部件保持在一起。因此,本公开的椎间保持架由多个互连零件形成,所述多个互连零件不需要额外的外部固定元件保持在一起。
更相关的是,以这种方式制造的装置应当不具有接缝,而传统制造的装置应当具有结合缝以将一个部件连接到另一个部件。这些接缝通常可表示可植入式装置的弱化区域,尤其是当这些接缝的粘结在反复使用或应力下随时间磨损或断裂时。通过使用增材制造来制造所公开的可植入式装置,优点之一是完全避免了接缝,并且因此避免了问题。
本装置的另一个优点是,通过使用增材制造工艺制造这些装置,装置的所有部件(即,椎间保持架和用于扩张和阻挡的销两者)在插入过程以及扩张过程两者中仍然是完整的构造。即,将多个部件一起作为集体单个单元提供,使得集体单个单元插入患者体内,被致动以允许扩张,然后被允许原位保持为集体单个单元。与需要插入外部螺钉或楔形件以用于扩张的其他保持架相比,在本实施方案中,扩张和阻挡部件不需要在过程期间的任何阶段处插入保持架中,也不需要从保持架中移除。这是因为这些部件被制造成被捕获在保持架内部,并且虽然可在保持架内自由移动,但是已经包含在保持架内,因此不需要额外的插入或移除。
在一些实施方案中,保持架可以用工程化细胞结构的一部分或全部制成,工程化细胞结构包括孔、微结构和纳米结构的网络以促进骨缝合。例如,工程化细胞结构可包括孔的互连网络和呈现网状外观的其他微米和纳米尺寸结构。可通过蚀刻或喷砂来提供这些工程化细胞结构以在纳米级上改变装置的表面。一种类型的蚀刻工艺可利用例如HF酸处理。此外,这些保持架还可包括内部成像标记,其允许使用者正确对齐装置并且通常通过在导航期间可视化而有利于插入。例如,成像标记在x射线、荧光透视或CT扫描下在网格中示出为实心主体。
本公开的可植入式装置提供的另一个有益效果是,它们能够根据患者的需要进行具体定制。可植入式装置的定制与在植入装置和待治疗的各种质量和类型的骨之间提供优选的模量匹配相关,诸如例如,皮质与松质骨、骨突与中央骨,以及骨硬化与骨质减少,它们中的每种对结构故障数据有其自身的不同压缩量。同样,也可针对各种植入物设计生成类似的数据,诸如例如多孔与实心、小梁对非小梁等。此类数据可以是标本数据或生成的计算机有限元。与例如DEXA数据相关联的临床相关性还可允许可植入式装置专门设计用于与硬化骨、正常骨或骨质减少的骨一起使用。因此,提供定制的可植入式装置诸如本文提供的那些装置的能力允许匹配复杂结构的弹性模量(EMOCS),这使得可植入式装置能够被设计成使不匹配最小化、减轻下沉并优化愈合,从而提供更好的临床结果。
在一个示例性实施方案中,提供了可扩张的脊柱植入物。可扩张的脊柱植入物可包括:被构造成用于抵靠第一椎体的端板放置的上板部件;被构造成用于抵靠第二相邻椎体的端板放置的下板部件;将上板部件和下板部件连接在一起并包括中间引导部件的关节运动机构,中间引导部件具有用于接纳致动销的内部腔体;以及包括轴和加大的头部的致动销,致动销被构造成实现上板部件和下板部件相对于彼此的关节运动,以成角度地调节可扩张脊柱植入物。关节运动机构可被构造成允许上板部件和下板部件相对于彼此滚动移动。
包括阻挡销的脊柱植入物可由增材生产技术制造,其中阻挡销被制造为单独的部件以驻留在保持架内部,但仍可在保持架内移动。在一些实施方案中,可扩张脊柱植入物可为PLIF(后腰椎体间融合)保持架。可扩张脊柱植入物可具有第一构型和第二构型,在第一构型中,板部件在前部处彼此成角度,然后在中间构型中彼此平行,在第二构型中,板构件被锁定在一起并且在后部处相对于彼此成角度。在第二构型中,植入物调节脊柱前凸角,并恢复脊柱的矢状平衡和对齐。
尽管以下讨论集中于脊柱植入物,但是应当理解,本原理中的许多同样可应用于需要在人体或动物体内进行骨修复或骨融合的其他结构体部位,包括其他关节,诸如膝盖、肩膀、脚踝或指关节。
应当理解,上述一般性的描述和以下详细的描述两者仅是示例性和说明性的,并不是对本公开的限制。本公开的附加特征将部分地在下面的描述中阐述,或者可通过本公开的实践获知。
附图说明
并入并构成本说明书一部分的附图示出了本公开的若干实施方案,并且与本说明书一起起到解释本公开的原理的作用。
图1示出根据本公开的椎间保持架的示例性实施方案的透视图。
图2A示出图1的椎间保持架的前视图。
图2B示出图1的椎间保持架的侧视图。
图2C示出图1的椎间保持架和阻挡销的后视图。
图2D示出图1的椎间保持架的头尾视图。
图2E示出图1的椎间保持架的等轴视图。
图3示出图1的椎间保持架和相关联的阻挡销的分解图。
图4A示出图1的椎间保持架和处于其制造位置的相关联的阻挡销的侧视图。
图4B示出图4A的椎间保持架和阻挡销的剖视图。
图5A-图5C示出图1的椎间保持架的上板部件的各种视图,其中,图5A示出侧视图,图5B示出局部剖视图,并且图5C示出透视图。
图6A-图6C示出图1的椎间保持架的中间关节运动部件的各种视图,其中,图6A示出侧视图,图6B示出透视图,并且图6C示出放大视图。
图7A-图7C示出图1的椎间保持架的下板部件的各种视图,其中,图7A示出侧视图,图7B示出局部剖视图,并且图7C示出透视图。
图8A和图8B示出图1的阻挡销的各种视图,其中,图8A示出俯视图,并且图8B示出透视图。
图9A-图9H示出扩张图1的椎间保持架的方法,其中,图9A、图9C、图9E和图9G示出在扩张过程中的保持架的侧视图,而图9B、图9D、图9F和图9H示出在扩张过程中的保持架的剖视图。
图9I示出图9C和图9D的椎间保持架的局部剖面后视图。
图9J示出图9C和图9D的椎间保持架的局部剖面前视图。
图10示出根据本公开的椎间保持架和相关联的阻挡销的另一个示例性实施方案的透视图。
图11A示出图10的椎间保持架的后视图。
图11B示出图10的椎间保持架的侧视图。
图11C示出图10的椎间保持架和阻挡销的前视图。
图11D示出图10的椎间保持架的头尾视图。
图11E示出图10的椎间保持架的等轴视图。
图12示出图10的椎间保持架和相关联的阻挡销的分解图。
图13A示出图10的椎间保持架和处于其制造位置的相关联的阻挡销的侧视图。
图13B示出图13A的椎间保持架和阻挡销的剖视图。
图14A-图14C示出图10的椎间保持架的上板部件的各种视图,其中,图14A示出侧视图,图14B示出局部剖面图,并且图14C示出透视图。
图15A-图15D示出图10的椎间保持架的中间关节运动部件的各种视图,其中,图15A示出侧视图,图15B示出透视图,图15C示出局部剖视图,并且图15D示出放大视图。
图16A和图16B示出图12的阻挡销的各种视图,其中图16A示出俯视图,并且图16B示出透视图。
图17A-图17J示出扩张图10的椎间保持架的方法,其中:
图17A、图17D和图17F示出在扩张过程中的保持架的侧视图;
图17B、图17E和图17G示出在扩张过程中的保持架的剖视图;
图17C示出图17A和图17B的椎间保持架的放大前视图;
图17H示出图17F和图17G的椎间保持架的放大前视图;
图17I示出图17F和图17G的椎间保持架的局部剖面后视图;
图17J示出图17F和图17G的椎间保持架的局部剖面前视图。
具体实施方式
本公开提供各种脊柱植入物装置,诸如椎体间融合间隔件或保持架,以用于在相邻椎骨之间插入。所述装置可被构造成用于脊柱的颈部区域或腰椎区域中。在一些实施方案中,这些装置被构造成作为PLIF保持架或后腰椎体间融合保持架。这些保持架可恢复和保持待治疗的脊柱节段的椎间高度,以通过恢复矢状平衡和对齐来稳定脊柱。在一些实施方案中,保持架可包含关节运动机构以允许扩张和角度调节。该关节运动机构允许上板部件和下板部件相对于彼此平滑地滑动。保持架可具有第一插入构型,第一插入构型的特征在于在保持架的插入端中的每个处的减小的尺寸,以有利于插入穿过狭窄的进入通路并插入椎间空间中。保持架可以以第一减小的尺寸插入,然后一旦植入就扩张到第二扩张尺寸。在它们的第二构型中,保持架能够保持适当的椎间盘高度并通过恢复矢状平衡和对齐来稳定脊柱。可以设想,在一些实施方案中,椎间保持架还可被设计成允许保持架以可自由选择(或无级)的方式扩张以达到其第二扩张构型。椎间保持架被构造成能够调节脊柱前凸角,并且可在其第二扩张构型中适应较大的脊柱前凸角。此外,这些保持架可促进融合以通过固定相邻椎体来进一步増强脊柱稳定性。
另外,可植入式装置可使用选择性激光熔融(SLM)技术(增材制造形式)来制造。这些装置也可通过其他类似的技术制造,诸如3D打印、电子束熔融(EBM)、层沉积和快速制造。利用这些生产技术,可创建一体化的多部件装置,该装置可具有互连和可移动的零件,而不进一步需要外部固定或附接元件来将部件保持在一起。因此,本公开的椎间保持架由多个互连零件形成,所述多个互连零件不需要额外的外部固定元件保持在一起。
更相关的是,以这种方式制造的装置应当不具有接缝,而传统制造的装置应当具有结合缝以将一个部件连接到另一个部件。这些接缝通常可表示可植入式装置的弱化区域,尤其是当这些接缝的粘结在反复使用或应力下随时间磨损或断裂时。通过使用增材制造来制造所公开的可植入式装置,完全避免了接缝,并且因此避免了问题。
此外,通过使用增材制造工艺制造这些装置,装置的所有部件(即,椎间保持架和用于扩张和阻挡的销两者)在插入过程和扩张过程中仍然是完整的构造。即,将多个部件一起作为集体单个单元提供,使得集体单个单元插入患者体内,被致动以允许扩张,然后被允许原位保持为集体单个单元。与需要插入外部螺钉或楔形件以用于扩张的其他保持架相比,在本实施方案,扩张和阻挡部件不需要在过程期间的任何阶段处插入保持架中,也不需要从保持架中移除。这是因为这些部件被制造成被捕获在保持架内部,并且虽然可在保持架内自由移动,但是已经包含在保持架内,因此不需要额外的插入或移除。
在一些实施方案中,保持架可以用工程化细胞结构的一部分或全部制成,工程化细胞结构包括孔、微结构和纳米结构的网络以促进骨缝合。例如,工程化细胞结构可包括孔的互连网络和呈现网状外观的其他微米和纳米尺寸结构。可通过蚀刻或喷砂来提供这些工程化细胞结构以在纳米级上改变装置的表面。一种类型的蚀刻工艺可利用例如HF酸处理。此外,这些保持架还可包括内部成像标记,内部成像标记允许使用者正确对齐保持架并且通常通过在导航期间可视化而有利于插入。例如,成像标记在x射线、荧光透视或CT扫描下在网格中示出为实心主体。
本公开的可植入式装置提供的另一个有益效果是,它们能够根据患者的需要进行具体定制。可植入式装置的定制与在植入装置和待治疗的各种质量和类型的骨之间提供优选的模量匹配相关,诸如例如,皮质与松质骨、骨突与中央骨,以及骨硬化与骨质减少,它们中的每种对结构故障数据有其自身的不同压缩量。同样,也可针对各种植入物设计生成类似的数据,诸如例如多孔与实心、小梁对非小梁等。此类数据可以是标本数据或生成的计算机有限元。与例如DEXA数据相关联的临床相关性还可允许可植入式装置专门设计用于与硬化骨、正常骨或骨质减少的骨一起使用。因此,提供定制的可植入式装置诸如本文提供的那些装置的能力允许匹配复杂结构的弹性模量(EMOCS),这使得可植入式装置能够被设计成使不匹配最小化、减轻下沉并优化愈合,从而提供更好的临床结果。
现在转到附图,图1示出了本公开的可扩张和角度可调节的关节运动椎间保持架10的示例性实施方案。椎间保持架10可包括一对关节运动壳体或板部件20、40,该壳体或板部件被构造成抵靠一对相邻椎体的端板放置。在一个实施方案中,关节运动板部件可包括用于抵靠端板放置的平坦承载表面。驻留在其间并被构造成与这些关节运动板部件20、40协作的是中间引导部件100,中间引导部件100有利于板部件20、40相对于彼此的移动,更具体地为平滑的滑动运动,如下所述。
如图2A和图2E中更详细地示出,其中,图2A示出保持架10的前视图,图2B示出保持架10的侧面或侧视图,图2C示出保持架10的后视图,图2D示出保持架10的头尾视图,并且图2E示出保持架10的等轴视图,保持架10可包括被构造成相对于彼此关节运动的上壳体或板部件20以及底壳体或板部件40。在本实施方案中,板部件20、40的移动可通过驻留在板部件20、40内和之间的关节运动接头机构来实现,该机构包括能够使部件20、40互相翻转的中间引导部件100。换句话讲,底板部件40用作基座,而上板部件20在基座40上翻转,以允许两个部件之间的平滑地滑动运动。
图3示出本实施方案的椎间保持架10和相关联的阻挡销60的组件的分解图。上板部件20可包括一对延伸臂或侧壁24。侧壁24中的每个可沿其一部分具有一个或多个脊或齿28。在侧壁24之间,可提供用于接纳中间引导部件100的内部腔体26(在图5C中示出)。
类似地,基座或下板部件40可包括一对延伸侧壁46。这些延伸侧壁46可限定用于在其间接纳中间引导部件100的狭槽或内部腔体48。在延伸侧壁46的顶部处为沿其一部分的一个或多个脊或齿52。如图4A所示,下板部件40的齿52可被构造成与上板部件20的齿28配合,并相对于齿28进行关节运动。在一些实施方案中,如果需要,上板部件20和下部部件40可在其自由端处在保持架10的第一前端12处逐渐变细。
如图2A至图2E以及图3所示,在上板部件20和下板部件40之间并且驻留在上板部件20和下板部件40内的是中间引导部件100,中间引导部件100有助于上板部件20和下板部件40相对于彼此进行摇摆运动。如图6A和图6B所示,中间引导部件100可包括面向上板部件20的滑动或滚动表面106。中间引导部件100的横向侧可包括可用作进行关节运动的引导腔体的切口部分或沟槽120。中间引导部件100还可包括用于接纳阻挡销60的内部腔体110。
如图3和图8A与图8B进一步所示,阻挡销60可包括细长轴64,加大的销头68附接到细长轴64。销头68可具有锁定表面72、引导表面74和调节表面76。在使用中,销60起到帮助上板部件20相对于底板部件或基座40倾斜或枢转的作用,并且一旦达到最终构型,就还阻挡部件20、40的移动,使得板部件20、40相对于彼此的位置可以被锁定并且不发生进一步的移动。
如上所述,本公开的可植入式装置可以以这样的方式制造:通过再生/增材生产技术(例如,选择性激光熔融(SLM))或如上所述的其他类似技术一步实现将所有部件加工成最终组装的装置。图4A和图4B示出示例性制造构型,该构型示出了如何在这样的技术下将保持架10和阻挡销60制造嵌套在一起。应当指出的是,在这里可利用再生/增材生产技术的有益效果来提供具有交互式部件的多部件组件,所述交互式部件不需要任何额外的外部固定元件以保持这些子部件完整且彼此相互作用。如图所示,保持架10加上阻挡销60的整个组件可作为具有可移动内部零件的一个单元一起生产。
如先前所提及的,以这种方式制造的装置应当不具有接缝,而传统制造的装置应当具有结合缝以将一个部件连接到另一个部件。这些接缝通常可表示可植入式装置的弱化区域,尤其是当这些接缝的粘结在反复使用或应力下随时间磨损或断裂时。通过使用增材制造来制造所公开的可植入式装置,这些装置的优点之一是完全避免了接缝,并且因此避免了问题。
图5A至图5C更详细地示出本公开的椎间保持架10的上板部件20。如图所示,上板部件20可包括一对延伸臂或侧壁24,在它们之间限定腔体或狭槽26,腔体或狭槽26被构造成接纳中间引导部件100。延伸侧壁24中的每个可沿其一部分包括一个或多个齿或脊28。齿28可被构造成与下板部件40的齿52配合并协作,如前所述。如图所示,上板部件20可被构造成座置在下基板部件40上。腔体26还可包括斜面34以及阻挡表面36,这些特征将在下文中更详细地描述。此外,如图所示,齿28被形成为板24的增厚部分的一部分,其中增厚部分的内部形成用于板部件20、40和中间引导部件100的关节运动的引导表面30。如图5B的剖视图所示,腔体26可包括滑动表面或滚动表面32。此外,与下板部件40一样,本实施方案中的上板部件20也可包括斜面34和阻挡表面36。事实上,在一些实施方案中,上板部件20可被构造成作为下板部件40的镜像。
图6A至图6C更详细地示出本公开的椎间保持架10的中间引导部件100。如图所示,中间引导部件100可包括面向上板部件20的滑动或滚动表面106。中间引导部件100的横向侧可包括可用作进行关节运动的引导腔体的沟槽120。中间引导部件100可包括用于接纳阻挡销60(如图3所示)的内部腔体。
此外,中间引导部件100的后部可包括端口或通道116,端口或通道116具有用于触及阻挡销60的开口118。
围绕通道116的是器械接口130,器械接口130允许通过卡口型附接将器械附接到装置10或销60。该器械接口130可在图6C中的放大细部图中看到。器械接口130可被构造成适应卡口型连接以允许例如递送器械附接到装置10或阻挡销60。器械接口130可包括外接触表面132、卡口配件134、围绕通道或端口116的凹槽136以用于器械插入,以及由通道116提供的圆柱形引导表面138。总起来说,器械接口130提供用于附接到其他器械的必要结构,包括用于插入可植入式装置10的递送器械和/或用于推进阻挡销60的工具。
图7A至图7C更详细地示出本公开的椎间保持架10的下板部件或基座40。如图所示和如前所述,下板部件40可包括在其中限定腔体或狭槽48的一对延伸侧壁46。该腔体48可被构造成接纳中间引导部件100。与上板部件20一样,下板部件40的齿52设置在侧壁46的增厚部分上,并且该增厚部分在其内部上具有用于部件一起进行关节运动的引导表面50。类似于上板部件20,腔体48还可包括斜面34以及阻挡表面36。如图7B的剖视图所示,腔体48可包括滑动表面或滚动表面58。
图8A和图8B示出可与本公开的椎间保持架10一起使用的阻挡销60的细节。阻挡销60可包括延伸到加大的销头68中的细长轴64。销头68可具有锁定表面72、引导表面74和调节表面76。
图9A至图9J示出扩张和成角度地调节本公开的椎间保持架10的过程。在其初始插入阶段或构型中,可扩张保持架10可具有压缩的减小的尺寸,由此上板部件20和下板部件40在保持架10的第一前端12处朝向彼此或朝向前侧成角度,如图9A和图9B所示。这产生锥形的鼻部或前顶端,以及最纤细轮廓(即最小的前高度)以有利于插入,这对于横贯狭窄的进入路径到达植入物位点特别有益。在一些实施方案中,如果需要,板部件20、40的端部还可包括斜面或锥形面。板部件20、40可各自包括平坦的外部承载表面,以接触并压靠椎体的端板。
上板部件20和下板部件40的互锁齿28、52的优点之一分别是部件20、40的移动以均匀、平滑的运动实现。换句话讲,板部件20、40的移动通过两个板部件20、40的抵靠彼此的棘轮运动同步。在当前构型中,不进行主动调整。
可被增材制造而成从而以第一插入构型驻留在中间引导部件100本身内的阻挡销60不干扰板部件20、40的枢转,并且可被认为在此时处于非主动状态。如图所示,阻挡销60位于中间引导部件100的腔体110内,但在该构型中不邻接板部件20、40的斜面34、54或阻挡表面36、56。
图9C和图9D示出处于中间位置或构型的保持架10。在该构型中,上板部件20和下板部件40彼此平行,并且限定椎间保持架10可能的最小插入高度。应当注意,阻挡销60在该中间构型中从保持架10的第二后端14朝向第一前端12向前推进,并且加大的头部68推压抵靠上板部件20和下板部件40。一旦保持架10已经穿过狭窄的进入路径并进入椎间/椎间盘内空间中,阻挡销60就可被继续推进,如图9E和图9F所示。阻挡销60向前或朝向第一前端12的推进导致上板部件20通过互锁齿28、52的滚动机构相对于下板部件40同步伸展分开。通过板部件20、40的平滑地滑动或引导表面32、58抵靠中间引导部件100来促进该滚动移动。如图所示,板部件20、40成角度或部分打开,其中在第一前端12处的前高度大于在第二后端14处的后高度。
图9G和图9H示出保持架10继续处于其主动调节阶段以及在保持架10的后端处的负载转移。当阻挡销60向前推进时,板部件20、40继续在第二后端14处朝向后部成角度,并且在第一前端12处朝向前部逐渐打开。如图所示,当完全调节时,保持架10现在可具有最大的前高度,即当阻挡销60在中间引导部件100内在其最前位置处时。在该构型中,负载转移到保持架10的后部,并且保持架10被完全地扩张或调节,并且处于其阻挡或锁定位置。在该最终的扩张位置,保持架10有效地适应椎骨节段的脊柱前凸角,并且可以恢复矢状平衡并与脊柱对齐。板部件20、40被构造成压靠椎体的端板,并且现在可固定并稳定该区域。
图9I和图9J示出了完全扩张的保持架10的各种局部剖面图。这些视图示出上部部件20和下部基座部件40的增厚部分的引导表面32、50在中间引导部件100的引导腔体或沟槽120内的协作。该特征确保复合结构在关节运动过程期间保持完整。即,当引导表面32、50也在引导腔体120内互锁时,齿28、52互锁在一起,以便在发生移动时保持配合在一起。同时,通过这些特征实现的滚动运动是平滑且同步的。
图10示出本公开的可扩张和角度可调节的椎间保持架210的另一个示例性实施方案。椎间保持架210与先前讨论的椎间保持架10具有许多类似的特征和有益效果,包括具有被构造成抵靠一对相邻椎体的端板放置的一对关节运动壳体或板部件220、240。在一个实施方案中,关节运动板部件220、240可包括用于抵靠端板放置的平坦承载表面。驻留在其间并被构造成与这些关节运动板部件220、240协作的是中间引导部件300,中间引导部件300有利于板部件220、240相对于彼此的移动,更具体地为平滑的滑动运动。该中间引导部件300被构造成接纳致动销260,致动销260在其向前推进时使得上板部件220和下板部件240能够平滑地抵靠彼此滚动,并且调节椎间保持架210的前端或第一前端212的角度。
如图11A至图11E中更详细地示出,其中,图11A示出保持架210的后视图,图11B示出保持架210的侧面或侧视图,图11C示出保持架210的前视图,图11D示出保持架210的头尾视图,并且图11E示出保持架210的等轴视图,保持架210可包括被构造成相对于彼此关节运动的上板部件220以及底板部件240。在本实施方案中,板部件220、240的移动可通过该中间引导部件300实现,中间引导部件300用作与这些板部件220、240配合的关节运动接头机构,从而允许板部件220、240彼此翻转。换句话讲,底板部件240用作基座,而上板部件220在基座240上翻转,以允许两个板部件220、240之间的平滑地滑动运动。提供起到阻挡板部件220、240的移动的作用的致动销260,并且致动销260被构造成可移动地驻留在中间引导部件300中。
图12示出本实施方案的椎间保持架210和相关联的致动销60的组件的分解图。上板部件220可包括一对延伸臂或侧壁224。在侧壁224之间,可提供用于容纳中间引导部件300的内部腔体226。类似地,基座或下板部件240可包括一对延伸侧壁246。这些延伸侧壁142可限定用于容纳中间引导部件300的狭槽或内部腔体248。如果需要,上板部件220和下部部件240可在其自由端处在保持架210的第一前端212处逐渐变细。
在上板部件220和下板部件240之间并且驻留在上板部件220和下板部件240内部的是中间引导部件300,中间引导部件100有助于上板部件20和下板部件40相对于彼此进行滚动运动。中间引导部件300可包括面向上板部件220和下板部件240的一对相对的棘轮表面306。这些棘轮表面306在其一部分上具有一系列齿308。中间引导部件300的横向侧可包括可用作进行关节运动的引导腔体的沟槽320,类似于上述那些沟槽。中间引导部件300可包括端口316,端口316具有用于触及致动销260的开口318。
如图16A与图16B进一步所示,致动销260可包括延伸到加大的销头268中的细长轴264。销头268可具有阻挡表面272和调节表面276。此外,销头268可包括在其侧面上的棘轮沟槽270,这将在后面进行详细说明。在轴264周围可设置凸缘266,如图所示。类似于阻挡销60,致动销260起到帮助上板部件220相对于底板部件或基座240倾斜或枢转的作用,并且一旦已经实现最终构型就还阻挡部件220、240的移动,使得上板部件220和下板部件240的相对位置可被锁定并且不可能进一步移动。
如上所述,本公开的可植入式装置可以以这样的方式制造:通过再生/增材生产技术(例如,选择性激光熔融(SLM))或如上所述的其他类似技术一步实现将所有部件加工成最终组装的装置。图13A和图13B示出示例性制造构型,该构型示出了如何在这样的技术下将保持架210和致动销260制造嵌套在一起。应当指出的是,在这里可利用再生/增材生产技术的有益效果来提供具有交互式部件的多部件组件,所述交互式部件不需要任何额外的外部固定元件以保持这些子部件完整且彼此相互作用。如图所示,保持架210加上致动销260的整个组件可作为具有可移动内部零件的一个单元一起生产。
图14A至图14C更详细地示出本公开的椎间保持架210的上板部件220。如图所示,上板部件220可包括一对延伸臂或侧壁224,在它们之间限定内部腔体或狭槽226,内部腔体或狭槽226被构造成接纳销260以及与中间引导部件300协作。在侧壁224的内侧上是细长狭槽252,细长狭槽252与中间引导部件300的指状突出部302协作,如下面将更详细描述的。
在上板部件220的内部内是一个或多个齿或脊228。齿228可被构造成与中间引导部件300的齿308配合并协作。如图所示,上板部件220可被构造成座置在下基板部件240上。腔体226还可包括斜面234以及阻挡表面236,这些特征将在下文中更详细地描述。如图14B的剖视图所示,内部腔体226可包括滑动表面或滚动表面232。上板部件220的下侧还包括被构造成以扣合连接的方式接纳中间引导部件300的凸起的引导件322以用于板的侧向稳定的腔体或凹槽222,以及允许中间引导部件300的指状突出部302的旋钮304的卡扣附接的腔体238。
应当理解,虽然此处未示出下板部件240的内部,但下板部件240可被视为上板部件220的镜像。因此,为上板部件220提供的所有特征也应当提供给下板部件240。
图15A至图15D更详细地示出本公开的椎间保持架210的中间引导部件300。如图所示,中间引导部件300可包括面向上板部件220和下板部件240的一对滑动或滚动表面306。中间引导部件300的横向侧可包括可用作进行关节运动的引导腔体的沟槽320。内部腔体310被构造成接纳致动销260。如图15C所示,可以提供延伸唇缘324以紧靠致动销260的轴264的凸缘266从而防止过度扩张。在中间引导部件300的前部处是扣合臂312,扣合臂312在其内部表面上的末端处具有凹口314以便于锁定。与扣合臂312侧接并且与其间隔开的是指状突出部302,指状突出部302在其外表面上的末端处具有旋钮304,以用于与上板部件220和下板部件240的凹槽238扣合接合。
此外,在中间引导部件300的后部处是端口或通道316,端口或通道316具有用于触及致动销260的开口318。围绕通道316的是器械接口330,器械接口330允许通过卡口型附接将器械附接到销260。该器械接口230可在图15D中的放大细部图中看到。器械接口330可被构造成适应卡口型连接以允许例如递送器械附接到保持架210或致动销260。器械接口330可包括外接触表面332、卡口配件334,以及围绕通道或端口316的凹槽336以用于器械插入,通道316提供围绕通道316的开口318的圆柱形引导表面以用于器械连接。总起来说,器械接口330提供用于附接到其他器械的必要结构,诸如用于保持架210的递送或致动销260的致动的器械。如图15D所示,凸起的引导件322设置在中间引导部件300的靠近后部的滚动表面306上,该引导件322可被接纳在上板部件220的凹槽222中。
图16A和图16B示出可与本公开的椎间保持架210一起使用的致动销260的细节。致动销260可包括延伸到加大的销头268中的细长轴264。销头268可具有阻挡表面272和调节表面276。另外,加大的销头268的侧面还可包括用于锁定致动机构的接合的沟槽270。在轴264的自由端处是与中间引导部件300的延伸唇缘324协作的凸缘266。
图17A至图17J示出扩张和成角度地调节本公开的椎间保持架210的过程。在其初始插入阶段或构型中,可扩张保持架210可具有压缩的减小的尺寸,由此上板部件220和下板部件240在保持架210的第一前端212处朝向彼此或朝向前侧成角度,如图17A至图17C所示。这产生锥形的鼻部或前顶端,以及最纤细轮廓(即最小的前高度)以有利于插入,这对于横贯狭窄的进入路径到达植入物位点特别有益。在一些实施方案中,如果需要,板部件220、240的端部还可包括斜面或锥形面。板部件220、240可各自包括平坦的外部承载表面,以接触并压靠椎体的端板。
与中间引导部件300的滚动表面306上的齿308互锁的板部件220、240的内部齿228的优点之一是部件220、240的移动以均匀、平滑的运动实现。换句话说,板部件220、240的移动同步。在当前构型中,不进行主动调整。如图17C进一步所示,在初始插入构型中,指状突出部302的旋钮304通过扣合在设置在部件220的内部上的凹槽238中而相对于上板部件220保持就位。
当致动销260向前推进或朝向第一前端212推进时,保持架210转变成中间位置或构型。在该中间构型中,上板部件220和下板部件240彼此平行,并且限定椎间保持架210可能的最小插入高度。该构型可以在图13A和图13B中看到。在转变期间,加大的头部268推压抵靠上板部件220和下板部件240。一旦保持架210已经穿过狭窄的进入路径并进入椎间/椎间盘内空间中,致动销260就可被继续推进,如图17D至图17E所示。通过由以下各项的组合实现的滚动机构,致动销260从第二后端214向前推进或朝向第一前端212推进导致上板部件220相对于下板部件240同步伸展分开:齿228、308以棘轮效应啮合在一起,以及板部件220、240的引导表面232抵靠中间引导部件300的平滑地滑动或移动,指状突出部302以导轨状方式在上板部件220的细长狭槽252以及下板部件240的对应狭槽内的滑动。如图所示,板部件220、240成角度或部分打开,其中在第一前端212处的前高度大于在第二后端214处的后高度。
图17D和图17E示出保持架210继续处于其主动调节阶段以及在保持架210的后端或第二后端处的负载转移。当致动销260向前推进时,板部件220、240继续朝向后侧成角度并且朝向前侧逐渐打开。如图17F至图17J所示,当完全调节时,保持架210现在可具有最大的前高度,即当致动销260处于其最前位置处时。在该构型中,负载转移到保持架210的后部或第二后端214,并且保持架210被完全地扩张或成角度调节,并且处于其阻挡或锁定位置。如图17H所示,在扣合臂312上与在致动销260上的沟槽270协作的导轨或凹口314现在与致动销260的加大的头部268上的沟槽270互锁,从而防止致动销的前部在中间引导部件300内进一步移动。在该最终的扩张位置,保持架210有效地适应椎骨节段的脊柱前凸角,并且可以恢复矢状平衡并与脊柱对齐。板部件220、240被构造成压靠椎体的端板,并且现在可固定并稳定该区域。
图17I和图17J示出了完全扩张的保持架310的各种局部剖面图。这些视图示出了齿在棘轮机构中的协作,指状突出部在细长狭槽内的滑动,中间引导部件的沟槽内的引导表面,以及致动销的沟槽内的扣合臂上的凹口。总的来说,这些特征确保复合结构在关节运动过程期间保持完整,以便在发生角度调节和移动时保持装配在一起。此外,本文提供的特征能够实现平滑的滑动移动,同时调节保持架210并防止其进一步的角度移动或扩张。
如上所述,本公开的椎间保持架10、210被构造成能够允许插入通过狭窄的进入路径,但是能够扩张和成角度地调节,使得保持架能够调节椎骨节段的脊柱前凸角。通过能够在关节运动接头处平滑地滚动,上板部件20、220可相对于基座或下板部件40、240有效地摇摆,以允许非常狭窄的前部用于插入并且在植入之后具有较大的前部以容纳并适应更大的脊柱前凸角。
另外,保持架10、210可有效地恢复脊柱的矢状平衡和对齐,并且可促进融合以固定并稳定脊柱节段。
相对于可扩张保持架10、210促进融合的能力,许多关于骨愈合和融合的体外和体内研究已经表明,孔隙度是允许血管形成所必需的,并且用于促进新骨生长所需的基础结构应当具有多孔互连孔隙网络,其表面特性针对细胞附着、迁移、增殖和分化加以优化。同时,许多人认为植入物为新细胞活动提供足够的结构支撑或机械完整性的能力是实现临床成功的主要因素,而其他人则强调孔隙率作为关键特征的作用。
无论一方面与另一方面相比的相对重要性如何,清楚的是稳定的结构完整性以及支持细胞生长的多孔结构均是适当和可持续骨再生的关键组成部分。
因此,这些保持架10、210可利用当前的增材制造技术,该技术允许通过创建可在一个中具有实心和多孔特征两者的整体式主体来允许定制更大的装置。在一些实施方案中,保持架10、210可具有多孔结构,并且可用工程化细胞结构制成,所述结构包括孔、微结构和纳米结构的网络以促进骨缝合。例如,工程化细胞结构可包括孔的互连网络和呈现网状外观的其他微米和纳米尺寸结构。可通过蚀刻或喷砂来提供这些工程化细胞结构以在纳米级上改变装置的表面。一种类型的蚀刻工艺可利用例如HF酸处理。可采用这些相同的制造技术来为这些保持架提供内部成像标记。例如,这些保持架还可包括内部成像标记,内部成像标记允许使用者正确对齐保持架并且通常通过在导航期间可视化而有利于插入。例如,成像标记在x射线、荧光透视或CT扫描下在网格中示出为实心主体。保持架可包括单个标记或多个标记。这些内部成像标记极大地有利于方便精确地植入保持架,因为可制造具有一个或多个内部嵌入标记的保持架,以用于改善导航和植入期间的可视化。
本公开的可植入式装置提供的另一个有益效果是,它们能够根据患者的需要进行具体定制。可植入式装置的定制与在植入装置和待治疗的各种质量和类型的骨之间提供优选的模量匹配相关,诸如例如,皮质与松质骨、骨突与中央骨,以及骨硬化与骨质减少,它们中的每种对结构故障数据有其自身的不同压缩量。同样,也可针对各种植入物设计生成类似的数据,诸如例如多孔与实心、小梁对非小梁等。此类数据可以是标本数据或生成的计算机有限元。与例如DEXA数据相关联的临床相关性还可允许可植入式装置专门设计用于与硬化骨、正常骨或骨质减少的骨一起使用。因此,提供定制的可植入式装置诸如本文提供的那些装置的能力允许匹配复杂结构的弹性模量(EMOCS),这使得可植入式装置能够被设计成使不匹配最小化、减轻下沉并优化愈合,从而提供更好的临床结果。
本公开可提供多种脊柱植入物,包括用于脊柱的颈部区域或腰椎区域中的椎体间融合保持架。虽然仅示出了后腰椎体间融合(PLIF)装置,但是可以预期在颈椎椎体间融合(CIF)装置、经椎间孔腰椎体间融合(TLIF)装置、前腰椎体间融合(ALIF)保持架、侧腰椎体间融合(LLIF)保持架和斜腰椎体间融合(OLIF)保持架中可以使用相同的原理。
在考虑了本文提供的本公开的说明书和实例的情况下,本公开的其他实施方案对于本领域的技术人员来说将是显而易见的。本说明书和示例旨在仅被示为示例性的。
Claims (21)
1.一种可扩张的脊柱植入物,包括:
上板部件和下板部件,所述上板部件被构造成抵靠第一椎体的端板放置,所述下板部件被构造成抵靠第二相邻椎体的端板放置;
关节运动机构,所述关节运动机构将所述上板部件和所述下板部件连接在一起并包括中间引导部件,所述中间引导部件具有用于接纳实际销的内部腔体;和
致动销,所述致动销包括轴和加大的头部,所述致动销被构造成在所述中间引导部件内移动,以实现所述可扩张脊柱植入物的角度调节。
2.根据权利要求1所述的可扩张脊柱植入物,其中包括所述致动销的所述脊柱植入物由增材生产技术制造。
3.根据权利要求1所述的可扩张脊柱植入物,其中所述致动销被制造成驻留在所述可扩张脊柱植入物的所述上板部件与所述下板部件以及所述中间引导部件的内部。
4.根据权利要求1所述的可扩张脊柱植入物,其中所述上板部件和所述下板部件中的每一者包括一对延伸侧壁,每个侧壁具有在内部表面上包含引导表面的增厚部分。
5.根据权利要求4所述的可扩张脊柱植入物,其中所述上板部件和所述下板部件的所述引导表面被构造成抵靠所述中间引导部件上的引导腔体移动。
6.根据权利要求4所述的可扩张脊柱植入物,其中所述加厚部分中的每个加厚部分在其一部分上包含一个或多个齿。
7.根据权利要求6所述的可扩张脊柱植入物,其中所述上板部件和所述下板部件的所述齿被构造成彼此互锁。
8.根据权利要求1所述的可扩张脊柱植入物,其中所述关节运动机构允许所述上板部件和所述下板部件相对于彼此滚动移动。
9.根据权利要求1所述的可扩张脊柱植入物,其中所述上板部件和所述下板部件中的每一者包括在其内部上的滚动表面,所述滚动表面被构造成在所述中间引导部件的顶面或底面上平滑地滑动。
10.根据权利要求1所述的可扩张脊柱植入物,其中所述上板部件和所述下板部件中的每一者包括在其内部上的一系列齿,所述齿被构造成在所述中间引导部件的所述顶面或底面上的一系列齿上渐进。
11.根据权利要求1所述的可扩张脊柱植入物,其中所述致动销在其最前侧位置处将所述上板部件和所述下板部件锁定在一起。
12.根据权利要求1所述的可扩张脊柱植入物,其中所述上板部件和所述下板部件在其自由端之一处逐渐变细。
13.根据权利要求1所述的可扩张脊柱植入物,其中所述保持架的所述后端被构造成具有器械接口。
14.根据权利要求1所述的可扩张脊柱植入物,其中所述中间引导部件被构造成相对于所述上板部件和所述下板部件上的细长狭槽滑动。
15.根据权利要求1所述的可扩张脊柱植入物,其中所述中间引导部件包括凸起突出部,所述凸起突出部被构造成用于与所述上板部件和所述下板部件内的腔体扣合接合。
16.根据权利要求1所述的可扩张脊柱植入物,还被构造为PLIF保持架。
17.根据权利要求1所述的可扩张脊柱植入物,还具有第一构型,其中所述板部件在所述脊柱植入物的前部处朝向彼此成角度。
18.根据权利要求1所述的可扩张脊柱植入物,还具有中间构型,其中所述板部件彼此平行。
19.根据权利要求14所述的可扩张脊柱植入物,还具有第二构型,其中所述板锁定在一起并在所述脊柱植入物的后部处朝向彼此成角度。
20.根据权利要求19所述的可扩张脊柱植入物,其中在所述第二构型中,所述植入物调节脊柱前凸角。
21.根据权利要求19所述的可扩张脊柱植入物,其中在所述第二构型中,恢复脊柱的矢状平衡和对齐。
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CN110037758A (zh) * | 2019-05-15 | 2019-07-23 | 成都五义医疗器械有限公司 | 一种安装基座和细长轴组件 |
CN110037758B (zh) * | 2019-05-15 | 2024-05-03 | 成都五义医疗科技有限公司 | 一种安装基座和细长轴组件 |
CN112842635A (zh) * | 2019-11-28 | 2021-05-28 | 刘俭涛 | 一种可滑动及自锁式寰枢椎椎间融合器 |
CN112842635B (zh) * | 2019-11-28 | 2023-10-20 | 刘俭涛 | 一种可滑动及自锁式寰枢椎椎间融合器 |
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JP2019520156A (ja) | 2019-07-18 |
WO2018002720A3 (en) | 2018-02-08 |
CN109640889B (zh) | 2021-07-30 |
US20230201001A1 (en) | 2023-06-29 |
JP2019520160A (ja) | 2019-07-18 |
WO2018002715A3 (en) | 2018-02-08 |
WO2018002715A2 (en) | 2018-01-04 |
US20170367845A1 (en) | 2017-12-28 |
US20170367844A1 (en) | 2017-12-28 |
US11596522B2 (en) | 2023-03-07 |
EP3474784A2 (en) | 2019-05-01 |
WO2018002720A2 (en) | 2018-01-04 |
AU2017286836B2 (en) | 2022-07-28 |
US11596523B2 (en) | 2023-03-07 |
AU2017286836A1 (en) | 2019-01-24 |
CN109688980B (zh) | 2022-06-10 |
JP7019616B2 (ja) | 2022-02-15 |
CN109688980A (zh) | 2019-04-26 |
US20230181332A1 (en) | 2023-06-15 |
JP7023877B2 (ja) | 2022-02-22 |
EP3474782A2 (en) | 2019-05-01 |
AU2017286831B2 (en) | 2022-06-09 |
AU2017286831A1 (en) | 2019-01-17 |
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