CN101909548A - 可膨胀椎间植入件以及制造它的相关方法 - Google Patents
可膨胀椎间植入件以及制造它的相关方法 Download PDFInfo
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- CN101909548A CN101909548A CN2009801022679A CN200980102267A CN101909548A CN 101909548 A CN101909548 A CN 101909548A CN 2009801022679 A CN2009801022679 A CN 2009801022679A CN 200980102267 A CN200980102267 A CN 200980102267A CN 101909548 A CN101909548 A CN 101909548A
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- Prior art keywords
- contact element
- side seam
- implantation piece
- seam contact
- intervertebral implant
- Prior art date
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- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y10/00—Processes of additive manufacturing
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P10/00—Technologies related to metal processing
- Y02P10/25—Process efficiency
Abstract
一种可膨胀椎间植入件(10)包括上侧骨接触元件(20)和下侧骨接触元件(30)以及至少一个垂直金属网(50),该垂直金属网使得上侧和下侧骨接触元件相互连接。上侧和下侧骨接触元件包括通过一个或多个横向金属网相互连接的至少两个骨接触部件,这样,植入件可从第一插入结构在原处横向和垂直地膨胀至第二膨胀结构。垂直和横向金属网优选是由多个单独的链环部件构成。本发明优选是还涉及椎间植入件的相关制作方法,这样,椎间植入件可以制造为整体部件或零件。
Description
相关申请的交叉引用
本申请要求美国临时专利申请No.61/021778的优先权,该美国临时专利申请No.61/021778的申请日为2008年1月17日,标题为“INTERVERTEBRAL SPACE AUGMENTATION”,该文献的内容整个被本文参引。
背景技术
人们(特别是老年人)可能患有骨质疏松。骨质疏松的一个方面可以是脊骨的骨结构局部或完全收缩,这又可能引起脊椎高度损失、椎间盘骨折、骨平面和神经碰撞等。脊骨的收缩通常导致例如疼痛、肺功能降低、不平衡体态等。一种治疗选择可以是外科手术处理,以便使得脊椎重新对齐(例如重新建立脊骨和椎间盘空间的平衡曲率)。
重新对齐包括受损的脊椎或椎间盘的脊骨可以通过用椎间植入件代替受损的脊椎、椎间盘或它们的部分来实现。也就是,椎间植入件可以插入两个相邻脊椎本体的椎间盘空间内,或者插入在除去脊骨的受损部分后由于除去部分或整个脊椎本体而产生的空间中。优选是,椎间植入件尽可能地使得脊骨恢复至自然状态,即恢复椎间盘或该系列脊椎的初始高度,并因此恢复在两个相邻或邻近脊椎本体之间或在脊骨的不同高度的脊椎本体之间的初始距离。
通常,一个或多个椎间植入件的植入并不是骨质疏松的治疗处理过程的一部分。一个原因可能是椎间植入件通常设计成具有很高的结构硬度。骨质疏松的骨通常较脆,因此增加了在外科手术或植入件的植入过程中脊椎终板(endplate)破裂的危险,且终板可能有不平坦的表面。例如,硬植入件可能撞上骨质疏松骨的不平坦表面的点或较小区域,从而产生了应力集中,并可能损坏该骨。因此,在某些病例中结合椎间植入件对于具有骨质疏松骨的病人是不合适的。并不结合椎间植入件的另一原因可能是用于植入椎间植入件的插入方法很困难和很危险,特别是对于老年病人。
也可选择,不是植入椎间植入件,而是外科医生可以选择在病人的脊骨上进行椎体成形术和/或腔静脉成形术处理。在执行椎体成形术和/或腔静脉成形术处理的示例方法中,保护套筒或套管可以插入病人体内并邻近病人的脊骨。然后,脊骨可以在骨折或重新骨折时重新对齐。然后,胶接剂插入脊骨中,以便代替失去的骨和/或限制以后的断裂。在胶接剂硬化后,脊骨的治疗部分可以重新对齐,病人可以再恢复他或她的日常活动。在腔静脉成形术处理中,空腔可以形成于一个或多个脊椎本体内,用于接收一部分胶接剂。
希望构造一种椎间植入件,它以相对小的尺寸相对简单地插入病人的脊骨中,且它能够膨胀,以便恢复除去的脊骨材料的初始高度,或者膨胀至外科医生所希望的高度。还希望构造一种椎间植入件,它可用于骨质疏松脊椎骨的不平坦表面,以便当植入件膨胀和与病人的终板接触或向该终板施加压力时限制应力集中。
发明内容
本发明涉及一种可膨胀椎间植入件。更具体地说,本发明的优选实施例涉及一种椎间植入件,它可以从收缩、未膨胀或第一插入结构横向和垂直地膨胀至第二膨胀结构。优选是,可膨胀椎间植入件包括通过一个或多个可膨胀部件(例如金属网)而连接在一起的上侧和下侧骨接触元件,这样,植入件可沿头/尾方向垂直膨胀。上侧和下侧的骨接触元件优选是由两个或更多的骨接触部件形成,所述骨接触部件通过一个或多个可膨胀部件(例如金属网)连接在一起,这样,植入件在通过前部接近植入时可沿横向方向横向膨胀,或者在通过横向接近植入时可沿前-后方向横向膨胀。
本发明还涉及一种插入椎间植入件并随后使它膨胀的相关方法以及制造该椎间植入件的相关方法,这样,椎间植入件可以制造为整体部件。
附图说明
当结合附图阅读时将更好地理解前面的概述以及后面的本发明优选实施例的详细说明。为了举例说明可膨胀椎间植入件、用于植入该椎间植入件的外科手术方法以及用于形成本发明的椎间植入件的制造方法,在附图中表示了优选实施例。不过,应当知道,本申请并不局限于所示的确切结构和仪器。附图中:
图1表示了本发明的示例椎间植入件的俯视透视图,植入件表示为处于收缩、未膨胀或第一插入结构;
图2表示了图1中所示的椎间植入件的俯视透视图,该植入件表示为处于第二膨胀结构;
图3A表示了图1中所示的椎间植入件的侧视图,该植入件表示为处于收缩、未膨胀或第一插入结构;
图3B表示了图1中所示的椎间植入件的侧视图,该植入件表示为处于第二膨胀结构;
图4A表示了图1中所示的椎间植入件的俯视图,该植入件表示为处于收缩、未膨胀或第一插入结构;
图4B表示了图1中所示的椎间植入件的俯视图,该植入件表示为处于第二膨胀结构;
图5A表示了图1中所示的椎间植入件的正视图,该植入件表示为处于收缩、未膨胀或第一插入结构;
图5B表示了图1中所示的椎间植入件的正视图,该植入件表示为处于第二膨胀结构;
图6A表示了可以用于形成金属网的链环部件的第一优选实施例的俯视透视图,该金属网可以用于图1所示的椎间植入件;
图6B表示了图6A中所示的金属网的俯视平面图,该金属网表示为处于至少局部收缩的未膨胀或第一插入结构;
图6C表示了图6A中所示的金属网的俯视平面图,该金属网表示为处于第二膨胀结构;
图7表示了可以用于形成金属网的链环部件的第二优选实施例的俯视透视图,该金属网可以用于图1所示的椎间植入件;
图8表示了可以用于形成金属网的链环部件的第三优选实施例的俯视透视图,该金属网可以用于图1所示的椎间植入件;
图9表示了可以用于形成金属网的链环部件的第四优选实施例的俯视透视图,该金属网可以用于图1所示的椎间植入件;
图10A-10C表示了图1中所示的椎间植入件的各种剖视图,上侧和下侧的骨接触元件与金属网合并,这样,上侧和下侧的骨接触元件能够分别用于上侧和下侧脊椎本体V的终板和/或与该终板一致;
图11A-11E表示了根据本优选发明一个方面用于横向插入图1的可膨胀椎间植入件的示例外科手术方法的步骤的各个透视图;以及
图12A-12L表示了根据本优选发明一个方面用于制造图1的可膨胀椎间植入件的示例方法的步骤的各个俯视透视图。
具体实施方式
下面的说明书中使用的某些术语只是为了方便,而不是限定。词语“右”、“左”、“顶部”和“底部”表示所参考的图中的方向。词语“向内”和“向外”是指分别朝向和远离装置和所述部件的几何中心的方向。词语“前面”、“后面”、“上面”、“下面”、“侧面”和相关词语和/或短语是指所参考的人体的优选位置和方位,而不是进行限制。术语包括上述词语、衍生词和类似意思的词。
现在将参考附图介绍本发明的某些示例实施例。通常,本发明的优选实施例涉及:(i)可膨胀椎间植入件10,用于在病人脊骨中的相邻脊椎本体V之间植入或者代替相邻脊椎本体V的受损部分(例如在腰部、胸部或颈部区域);(ii)用于在病人的脊骨的相邻脊椎本体V之间植入椎间植入件10的示例外科手术方法;以及(iii)制造椎间植入件10的示例方法。更具体地说,本发明优选是涉及一种可膨胀的椎间植入件10,用于总体或局部的椎间盘或脊椎本体V的替换,或者用于椎间盘空间S的髓核替换。应当知道,尽管本申请的可膨胀椎间植入件10将结合脊骨椎间盘替换来介绍,但是本领域技术人员应当知道,植入件10以及它的部件可以用于身体其它部位的组织代替,例如膝盖、髋、肩部、手指或其它关节替换,或者用于骨增大。
下面将参考图1-5B更详细地说明,可膨胀椎间植入件10优选地用于病人的脊骨的椎间支承,该病人需要在脊骨的一个或多个高度处进行体内熔化。优选是,可膨胀椎间植入件10在收缩、未膨胀或第一插入结构中(如图1、3A、4A和5A中最佳地示出)由外科医生植入病人体内,从而与植入不可膨胀的椎间植入件(未示出)的通常所需相比能够有更小的切口。优选的可膨胀椎间植入件10在第一插入结构中植入也可以使得它更容易经过可能阻止外科医生进入脊骨的结构而插入该植入件10。可膨胀椎间植入件10使得外科医生能够将更大的椎间植入件植入椎间盘空间S中,且通常不必进行过大量的骨切除和软组织缩回。一旦植入件10插入椎间盘空间S中,植入件10可以膨胀至第二膨胀结构(如图2、3B、4B和5B中最佳地示出)。更优选是,植入件10可沿头/尾方向膨胀,以便提供平行和/或脊柱前凸的椎间分散,且植入件10可沿横向方向膨胀。也就是,可膨胀椎间植入件10优选是在收缩、未膨胀或第一插入结构中由外科医生植入病人体内,在该第一插入结构中,植入件具有第一高度H1和第一宽度W1。然后,一旦插入椎间盘空间S中,植入件10可以膨胀至第二膨胀结构,在第二膨胀结构中,植入件10具有第二高度H2和第二宽度W2,其中,该第二高度H2和第二宽度W2分别大于第一高度H1和第一宽度W1。
优选的可膨胀椎间植入件10例如可以充满整个椎间盘空间S,以便代替整个椎间盘。也可选择,多个可膨胀椎间植入件10可以用于充满椎间盘空间S。例如,两个或更多较小的可膨胀椎间植入件10可以用于充满椎间盘空间S。也可选择,可膨胀椎间植入件10的尺寸和结构设置成只能局部代替椎间盘空间S,例如用于代替髓核。此外,优选的椎间植入件10可以设置成代替椎间盘以及受损的脊椎V的一部分。
可膨胀椎间植入件10优选是包括:上侧骨接触元件20,用于接触第一、上侧脊椎V;下侧骨接触元件30,用于接触第二、下侧脊椎V;以及垂直金属网或网格50,用于使得上侧和下侧骨接触元件20、30彼此相互连接。优选是,当植入件10插入椎间盘空间S内时,垂直金属网50使得上侧和下侧骨接触元件20、30能够在从收缩、未膨胀或第一插入结构运动至第二膨胀结构的过程中沿头/尾方向或大致相互离开地运动(例如膨胀)。上侧和下侧骨接触元件20、30的尺寸和结构设置成分别与上侧和下侧脊椎本体V的终板的至少一部分接触,或者与在从脊骨上除去上侧和/或下侧脊椎V的受损部分之后剩余的上侧和/或下侧脊椎本体V的表面接合。上侧和下侧骨接触元件20、30优选是限定了在它们之间的空腔40。
示例优选实施例的上侧骨接触元件20由通过横向金属网或网格50′相互连接的两个或更多骨接触部件22而形成。类似地,该示例性优选实施例的下侧骨接触元件30由通过横向金属网50′相互连接的两个或更多骨接触部件32而形成。也就是,上侧和下侧骨接触元件20、30各自优选是由通过可横向膨胀的金属网50′而分离或相互连接的多个大致刚性骨接触部件22、32而构成,这样,形成骨接触元件20、30的骨接触部件22、32可彼此相对运动(例如可膨胀)。如图所示,骨接触部件22、32优选是为一个或多个板的形式,更优选是L形板,尽管可以考虑其它形状。不过,骨接触元件20、30可以构成为单个整体部件,例如,当植入件10构成为只沿头/尾方向膨胀时。此外,上侧和下侧的骨接触元件20、30可以有凸形表面,它们与脊椎V的终板接触,以便与终板的形状一致。
这样,通过在上侧和下侧骨接触元件20、30之间结合垂直金属网50,植入件10可从收缩、未膨胀或第一插入结构(其中,植入件10具有第一高度H1)膨胀至第二膨胀结构(其中,植入件10具有第二高度H2),其中,第二高度H2大于第一高度H1。类似地,通过在相邻骨接触部件22、32(该骨接触部件22、32分别形成上侧和下侧骨接触元件20、30)之间结合横向金属网50′,植入件10可从收缩、未膨胀或第一插入结构(其中,植入件10具有第一宽度W1)膨胀至第二膨胀结构(其中,植入件10具有第二宽度W2),其中,第二宽度W2大于第一宽度W1。也就是,横向金属网50′优选是使得骨接触部件22、32能够沿横向轴线A2相对彼此横向运动(例如根据插入过程而沿前后或横向方向),同时垂直金属网50使得上侧和下侧的骨接触元件20、30能够沿垂直轴线A3相对于彼此垂直运动。此外,垂直和横向金属网50、50′使得上侧骨接触元件20能够相对于下侧骨接触元件30沿纵向轴线A1运动。因此,垂直和横向金属网50、50′使得植入件10在第二或膨胀结构中的最终形状适合匹配脊椎本体V的终板的通常不平坦表面。此外,垂直和横向金属网50、50′使得植入件10能够限制在植入件10和脊椎本体V之间的接触点处的应力增加,从而使得优选的植入件10适于在骨质疏松骨之间插入。
也就是,在优选实施例中,通过由垂直和横向金属网50、50′相互连接的四个骨接触部件22、32形成优选的植入件10,植入件10的上侧和下侧骨接触元件20、30优选地能够彼此相对沿六个自由度运动。具体地说,上侧和下侧骨接触元件20、30能够沿纵向轴线A1相对彼此纵向运动,沿横向轴线A2相对彼此横向运动、沿垂直轴线A3相对彼此垂直运动、绕纵向轴线A1相对彼此枢转或滚转、绕横向轴线A2相对彼此枢转或倾斜、以及绕垂直轴线A3而相对彼此枢转或偏转。因此,优选的植入件10能够使得它在第二或膨胀结构中的最终形状适合与脊椎本体V的终板的通常不平坦表面匹配,并限制在植入件10和脊椎本体V之间的接触点处的应力增加。
应当知道,可以设想,上侧和下侧骨接触元件20、30可以由通过横向金属网50′和纵向金属网(未示出)相互连接的四个或更多骨接触部件22、32而形成,这样,植入件10可沿纵向从第一长度运动成第二长度(未示出)。也可选择,上侧和下侧骨接触元件20、30可以由通过纵向金属网(未示出)(但是没有横向金属网50′)相互连接的两个骨接触部件22、32而形成,这样,植入件10可沿纵向从第一长度运动成第二长度(未示出),但是不能沿横向从第一宽度W1运动成第二宽度W2。
垂直金属网50和横向金属网50′优选地能够运动大约十分之三毫米(0.3mm)至大约12毫米(12mm),尽管也可以为其它运动量,如本领域普通技术人员已知。而且,植入件并不局限于具有如图1-12L所示的大致矩形或盒形形状,例如,植入件10可以有大致圆形或圆柱形形状的系列环,这些环形成由金属网分开的上侧和下侧骨接触元件20、30,这样,内部环可以沿纵向轴线A3膨胀得比外部环更远,以便适应凹形形状的终板。
参考图6A-6C,垂直和/或横向金属网50、50′的第一优选示例实施例通过使得多个单独的第一链环部件52相互连接而形成。如图所示,多个单独的第一链环部件52在至少局部膨胀时可以有大致矩形形状,但是并不局限于此。参考图7,横向和/或垂直金属网50、50′的第二优选示例实施例可以通过使得多个单独的第二链环部件52′相互连接而形成,其中,该多个单独的第二链环部件52′在至少局部膨胀时具有大致梯形形状,但是并不局限于此。参考图8,横向和/或垂直金属网50、50′的第三优选示例实施例可以通过使得多个单独的第三链环部件52″相互连接而形成,其中,该多个单独的第三链环部件52″在至少局部膨胀时具有交替的第二矩形形状,但是并不局限于此。参考图9,横向和/或垂直金属网50、50′的第四优选示例实施例可以通过使得多个单独的第四链环部件52″′相互连接而形成,其中,该多个单独的第四链环部件52″′在至少局部膨胀时具有交替的第三矩形形状,但是并不局限于此。也可选择,垂直和/或横向金属网50、50′可以具有任意其它形式或形状,例如可塑性变形材料、网格、可伸展件等,只要垂直和/或横向金属网50、50′相互连接,并使得上侧和下侧骨接触元件20、30和/或上侧和下侧骨接触部件22、32能够相对彼此运动。优选地单独的链环部件52、52′、52″、52″′并不局限于大致矩形或梯形形状,几乎可以采取任何形状,例如椭圆形、圆形、三角形、六边形等。
此外,通过由多个优选地单独的第一、第二、第三和/或第四链环部件52、52′、52″、52″′形成或构成垂直和/或横向金属网50、50′,上侧和/或下侧骨接触部件22、32能够相对彼此倾斜或大致运动,这样,上侧和下侧骨接触元件20、30能够更好地适应相邻脊椎本体V的终板的结构。也就是,如前所述,通过由垂直和横向金属网50、50′相互连接的四个骨接触部件22、32形成优选的植入件10,垂直和/或横向金属网50、50′的柔性使得植入件10的上侧和下侧骨接触元件20、30能够彼此相对沿六个自由度运动,这样,植入件10特别是上侧和下侧骨接触元件20、30能够更好地分别用于和/或适应上侧和下侧脊椎本体V的终板的解剖形状。如图10A-10C中所示,由于由通过柔性金属网50、50′相互连接的多个部件22、32形成上侧和下侧骨接触元件20、30的固有柔性或适应性,上侧和下侧骨接触部件22、32能够更好地分别用于和/或适应上侧和下侧脊椎本体V的终板。因此,在使用中,横向金属网50′使得上侧骨接触部件22能够相对彼此运动,并使得下侧骨接触部件32能够相对彼此运动,这样,横向金属网50′使得上侧和下侧骨接触元件20、30能够分别用于和/或适应上侧和下侧脊椎本体V的终板。
优选的植入件10还包括位于上侧和下侧骨接触元件20、30之间的空腔40。该空腔40的尺寸和形状优选地设置成接收填充材料(未示出)和/或气囊75、膨胀袋、膨胀包等(本文中统称为“膨胀部件”)。膨胀部件75的尺寸和形状优选地设置成容纳在空腔40内,以便限制任意填充材料从空腔40溢流和逸出。更优选地,如后面更详细所述,优选地,一旦植入件10被植入和定位,膨胀部件75就插入空腔40中。然后,填充材料可以插入膨胀部件75中,从而使得膨胀部件75膨胀,这样,植入件10从收缩、未膨胀或第一插入结构膨胀至第二膨胀结构。优选地,填充材料一旦插入就硬化或者交联,以便将植入件10支承在第二膨胀结构。也可选择,填充材料可以并不硬化,并可以局部硬化成凝胶状材料,或者保持可流动或液体状态,并密封在膨胀部件75中。
应当知道,膨胀部件75的膨胀可以使得或并不使得相邻脊椎本体V分散。不过,膨胀部件75的柔性和填充材料的随后硬化优选地提供了椎间盘空间S的几何适应恢复。也可选择,填充材料可以保持在凝胶和/或液体状态,并可以密封在膨胀部件75中。此外,如本领域普通技术人员通常已知,膨胀部件75可以在植入件10植入之前插入空腔40中,填充材料可以在植入件10植入之前注入膨胀部件75中,膨胀部件75可以与植入件10成一体或与该植入件10连接,和/或膨胀部件75可以完全省略。
而且,应当理解,上侧和下侧骨接触元件20、30可以包括任意数目的骨接触部件22、32和相互连接的横向金属网50′,例如通过两个横向金属网50′相互连接的三个骨接触部件22、32。还可以设想,植入件10可以包括在上侧和下侧骨接触元件20、30之间的一个或多个中间部件(未示出)。这些中间部件可以通过垂直金属网50而与上侧和下侧骨接触元件20、30连接。而且,还可以设想,植入件10可以包括垂直金属网50,以便能够沿头/尾方向膨胀,而没有结合横向金属网50′。也可选择,植入件10可以包括横向金属网50′,以便能够横向膨胀,而没有结合垂直金属网50。
上侧和下侧骨接触元件20、30可以包括用于提高植入件10的稳定性的装置,例如一个或多个凸起,一个或多个粗糙表面、一个或多个波动结构、一个或多个脊、一个或多个龙脊(keel)等。优选地,上侧和下侧骨接触元件20、30包括多个齿21,用于增加植入件10的稳定性。
植入件10还可以包括用于与植入件插入仪器(未示出)接合的机构或特征。用于与插入仪器接合的机构或特征可以采取目前或以后已知的任意形式,例如一个或多个孔102,用于接收形成于植入件插入仪器上的一个或多个凸起(未示出);一个或多个凸起(未示出),用于与形成于植入件插入仪器上的一个或多个孔(未示出)接合;一个或多个槽道(未示出),用于接收形成于植入件插入仪器上的一个或多个尖端;一个或多个螺纹孔(未示出),用于接收一个或多个螺纹杆或螺钉;等等。
植入件10还可以包括用于在插入过程中减小和/或防止剪切或拆开植入件10的机构或特征,例如,上侧和下侧骨接触元件20、30可以包括相互连接的凸起24和孔34,用于将植入件10暂时固定在它的收缩或插入结构。
上侧和下侧骨接触元件20、30可以由任意生物相容的材料形成,包括但不局限于:金属例如钴-铬-钼(CCM)合金、钛、钛合金、不锈钢、铝等;陶瓷例如氧化锆、氮化硅等;同种异体移植物、自体移植物、金属-同种异体移植物的组合;聚合物例如聚芳醚酮(PAEK)、聚醚醚酮(PEEK)、聚醚酮酮(PEKK)、聚醚酮(PEK)、聚醚酮-醚酮酮(PEK-EKK)等。聚合物可以由纤维增强,例如,碳纤维或其它较细的硬纤维。
上侧和下侧骨接触元件20,30也可以进行涂覆,以便提高它们的骨导电性能。例如,骨接触元件20,30可以进行涂覆,所述涂覆通过蚀刻、阳极氧化、阳极等离子体化学处理,电镀,等离子喷涂、由物理或化学蒸气沉积处理获得一层薄的钛(Ti)、阳极等离子体化学表面处理(包括例如在Ti氧化物表面层中的Ca和/或P)、或通过Ti或HA等离子体喷涂等进行。
膨胀部件75可以由任意生物相容的材料来制造,该生物相容材料包括但不局限于:聚氨酯、聚碳酸酯聚氨酯、聚碳酸酯-硅酮聚氨酯共聚物、聚胺、聚对苯二甲酸乙二醇酯(PET)、聚已酸内酯等。
填充材料可以为本领域已知的任意生物相容材料,并可以为刚性或弹性材料。填充材料例如可以包括:骨水泥、水凝胶、聚乙烯醇、聚丙烯酸钠、丙烯酸酯聚合物、甲基丙烯酸甲酯、具有大量的亲水基团的共聚物、p-乙烯基吡咯烷酮(pyrollidone)、聚乙烯亚胺等、设定或固化的水凝胶基共聚物,例如,聚乙烯亚胺,聚(甲基丙烯酸二乙胺基乙酯)、聚(甲基丙烯酸乙胺基乙酯(ethylaminoethyl))等、热固性水凝胶基共聚物,例如具有聚乙二醇的聚N-异丙基丙烯酰胺,聚环氧乙烷和聚苯醚(polyphenelyleneoxide)的共聚物、聚乙二醇和聚乳酸的共聚物等、离子固化水凝胶,例如,丙烯酸乙酯、甲基丙烯酸、1,4-丁二醇二丙烯酸酯(1,4-butanediacrylate)等,或者PCU、PCU-硅酮共聚物、硅酮或其它非再吸收性纯或弹性共聚物(例如,PCU的硅酮端基改性的PU、RTV固化硅氧烷基弹性体)。
插入椎间植入件的示例方法
可膨胀椎间植入件10可以通过本领域目前或以后已知的任意装置、方法或方式来插入目标椎间盘空间S中,它们包括但不限于通过前部,侧部,后部,前-侧部或后-侧部途径等。优选地,植入件10利用微创技术来植入。也可选择,植入件10可以通过开放切口来植入,如本领域普通技术人员已知的那样。
参考图11A-11E,在通过侧部接近来插入植入件10的一个示例方法中,植入件10通过插入仪器(未示出)而在相邻的上侧和下侧脊椎本体V之间插入椎间盘空间S中。如图11A所示,在优选地微创穿过皮肤到椎间盘空间S之后,植入件10优选地以收缩、未膨胀或第一插入结构插入椎间盘空间S中。如图11B中所示,植入件10优选地位于椎间盘空间S中并至少局部处于后部方向,以便基本保持运动段平衡。更优选地,植入件10应当定位成使得植入件10与相邻脊椎本体V的更强周边方位接合。一旦植入件10被正确定位在它的所需位置,如图11C中所示,植入件10优选地通过手术仪器(未示出)沿前后方向(当植入件10通过前部或后部途径来插入时沿横向方向)横向膨胀。也可选择,植入件10可以在其中有膨胀部件或气囊75的情况下插入,并通过膨胀部件75来横向膨胀。优选地,这时应当检查植入件的位置,以便保证优选定位。一旦大致基于外科医生的优先选择和/或生理学来验证了植入件10的位置,如图11D所示,膨胀部件75就通过插入仪器(未示出)插入和定位在形成于植入件10中的空腔40。如果需要,植入件10可以通过植入件插入仪器而稍微膨胀,以便使得膨胀部件75容易插入空腔40中。然后,膨胀部件75充满填充材料,这使得植入件10沿头/尾方向膨胀,优选地导致植入件10牢固地穿入相邻的上侧和下侧脊椎本体V的终板中。由于垂直和/或横向金属网50、50′的适应性,植入件10的上侧和下侧骨接触元件20、30可以基本分别与上侧和下侧脊椎本体V的终板的通常不平坦表面匹配。例如,单个骨接触部件22、32可以沿纵向、横向和/或垂直方向A1、A2、A3而彼此相对线性运动,并可以绕纵向、横向和/或垂直轴线A1、A2、A3而彼此相对枢转,这样,植入件10在膨胀结构中的形状与脊椎V的先前的终板的解剖学形状一致。具体地说,各骨接触部件22、32可沿六个自由度相对彼此运动,以便使得各组件的最终位置适应病人的解剖学结构,从而减小应力增加,当植入件不能与解剖学形状一致时可能产生应力增加。
制造椎间植入件的示例方法
优选的可膨胀椎间植入件10可以通过本领域在目前或以后知道的任意装置和/或方法来制造,这些装置和/或方法包括但不局限于:通过将各骨接触元件20、30制造为单独和离散的组件,然后根据需要使得各组件与垂直和横向金属网50、50′连接。
不过,优选地,植入件10形成为通过层状或一层层的制造方法制造的整体植入件。例如,参考图12A-12L,植入件10优选地通过选择性的激光熔化方法来制造。金属部件优选地成层地设置,类似于立体石印。在使用时,将薄层金属粉末施加在平台上。然后,粉末例如通过激光束而局部熔化。然后,平台降低限定的层高度。然后施加另一薄层金属粉末。然后,第二层粉末局部熔化。重复该过程,直到完成植入件10。能够将植入件10制造为单个或整体部件或零件将允许在骨接触部件22、32之间制造连续环或固体的(solid)垂直和横向金属网50、50′。相反,用于构造垂直和横向金属网50、50′的可选技术可能需要将金属线的端部连接在一起,以便构成优选的第一、第二、第三和第四链环部件52、52′、52″、52″′。
也可选择,植入件10可以通过选择激光烧结方法来制造。通常,激光烧结方法将遵循与上述选择激光熔化方法相同的步骤。不过,因为烧结在基体材料的熔点之下进行,因此激光烧结方法能够使得原始金属粉末与粘接剂混合。在激光烧结处理之后可以使用汽提处理。利用激光烧结处理,可以制造金属和微孔结构的组合。激光烧结方法也可以与热塑性聚合物结合使用,该热塑性聚合物没有任何特定的熔点,而是有在玻璃化转变温度和熔块温度之间的过渡区域。
尽管已经介绍了激光熔化和烧结方法,但是也可以考虑其它制造方法,包括但不局限于其它固化或烧结方法,例如使用超声波或紫外线。
这里所述的特征可以单独使用或与其它特征组合使用。此外,结合一个实施例所述的特征可以与在另一实施例中所述的特征互换。因此,这里所述的实施例是作为示例性的,而不是进行限制,本发明的范围将由附加权利要求来表示,而不是限制为前述说明书。
本领域技术人员应当知道,在不脱离本发明的广义概念的情况下可以对上述实施例进行变化。因此,应当知道,本发明并不局限于所述特殊实施例,而是将覆盖由附加权利要求限定的本发明精神和范围内的变化形式。
Claims (11)
1.一种可膨胀椎间植入件,其包括:
上侧骨接触元件,该上侧骨接触元件包括通过第一横向金属网相互连接的至少两个骨接触部件;
下侧骨接触元件,该下侧骨接触元件包括通过第二横向金属网相互连接的至少两个骨接触部件;以及
至少一个垂直金属网,该垂直金属网使得上侧骨接触元件和下侧骨接触元件相互连接,其中,第一横向金属网、第二横向金属网和垂直金属网包括多个单独的链环部件,植入件可在原位从第一插入结构置膨胀至第二膨胀结构,植入件具有在第一插入结构的第一高度和第一宽度以及在第二膨胀结构的第二高度和第二宽度,第二高度大于第一高度,第二宽度大于第一宽度。
2.根据权利要求1所述的植入件,其中:所述多个单独的链环部件具有矩形形状。
3.根据权利要求1所述的植入件,其中:所述多个单独的链环部件具有梯形形状。
4.根据权利要求1所述的植入件,还包括:
空腔,该空腔限定于上侧骨接触元件和下侧骨接触元件之间;以及
膨胀部件,该膨胀部件可插入空腔中,该膨胀部件能够接收填充材料,从而填充材料注入膨胀部件中使得将上侧骨接触元件和下侧骨接触元件相互连接的垂直金属网膨胀,由此使得上侧骨接触元件相对于下侧骨接触元件运动,从而使得植入件从第一高度垂直膨胀至第二高度。
5.根据权利要求4所述的植入件,其中:形成上侧骨接触元件和下侧骨接触元件的该至少两个骨接触部件包括一个或多个孔,用于与外科手术仪器接合。
6.根据权利要求1所述的植入件,其中:形成上侧骨接触元件和下侧骨接触元件的该至少两个骨接触部件包括相互连接的凸起和孔。
7.根据权利要求1所述的植入件,其中:上侧骨接触元件、下侧骨接触元件和该至少一个垂直金属网通过层状制造方法而构成为整体部件。
8.根据权利要求7所述的植入件,其中:该层状制造方法是选择性的激光熔化方法。
9.根据权利要求7所述的植入件,其中:该层状制造方法是选择性的激光烧结方法。
10.一种制造可膨胀椎间植入件的方法,该椎间植入件包括上侧骨接触元件和下侧骨接触元件,该上侧骨接触元件和下侧骨接触元件通过至少一个金属网而相互连接,上侧骨接触元件和下侧骨接触元件包括通过一个或多个横向金属网相互连接的至少两个骨接触部件,使得植入件可从第一插入结构横向和垂直地膨胀至第二膨胀结构,该至少一个金属网包括多个单独的链环部件,该方法包括以下步骤:
(a)将第一层金属粉末施加在活动平台上;
(b)熔化第一层金属粉末,以便限定第一固体层;
(c)使得平台降低限定的层高度;
(d)将第二层金属粉末施加在活动平台上;
(e)熔化第二层金属粉末,以便限定第二固体层,该第二固体层与第一固体层相互连接;
(f)重复步骤(c)-(e)多次,以便形成具有至少两个连续的单独链环部件的可膨胀椎间植入件。
11.根据权利要求10所述的方法,其中:在步骤(b)和(e)中的金属粉末通过激光束来熔化。
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WO2009092102A1 (en) | 2009-07-23 |
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CA2710142A1 (en) | 2009-07-23 |
KR20100113084A (ko) | 2010-10-20 |
AU2009205896A1 (en) | 2009-07-23 |
US20150257892A1 (en) | 2015-09-17 |
JP5441922B2 (ja) | 2014-03-12 |
CN101909548B (zh) | 2014-07-30 |
US20170165085A1 (en) | 2017-06-15 |
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