CN102625682A - 采用同轴螺纹齿轮套机构的椎体撑开与融合方法及装置 - Google Patents
采用同轴螺纹齿轮套机构的椎体撑开与融合方法及装置 Download PDFInfo
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- CN102625682A CN102625682A CN2010800430156A CN201080043015A CN102625682A CN 102625682 A CN102625682 A CN 102625682A CN 2010800430156 A CN2010800430156 A CN 2010800430156A CN 201080043015 A CN201080043015 A CN 201080043015A CN 102625682 A CN102625682 A CN 102625682A
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- A—HUMAN NECESSITIES
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Landscapes
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Abstract
根据本发明多种实施例的用于椎体撑开和融合的改进方法和装置采用一或多各同轴螺纹齿轮套机构。多种实施例中,同轴螺纹齿轮套机构包括带有螺纹外表面的柱件及配置为围绕所述柱件的相应套筒,所述相应套筒包括与所述柱件的螺纹外表面接合的螺纹内表面以及齿轮外表面。驱动机构可具有配置为与所述套筒的齿轮外表面接合并且使装置撑开。
Description
相关申请
本申请要求申请于2009年7月22日的第61/271,548号美国临时申请以及申请于2010年7月16日的第61/365,131号美国临时申请的权益。
技术领域
本发明涉及椎体的撑开与融合。更具体地,本发明涉及采用同轴螺纹齿轮套机构的椎体撑开与融合的装置及相关方法。
背景技术
随着椎间盘切除术的出现,大约是在二十世纪六十年代,提出了用于颈椎和腰椎的椎间融合的概念。它涉及从臀部取出骨移植物,并且将移植物植入椎间盘隙(disc space)。在椎间盘隙挖出与植入物匹配的空间而对椎间盘隙进行制备。这一概念的好处在于它提供了较大表面积的骨对骨接触,并且在承受负载力的状态下放置移植物,从而允许加强骨融合的骨传导和骨诱导。然而,由于存在诸多不利因素,诸如手术时间长、椎间盘的破坏多、神经损伤风险大、及取出骨移植物后的臀部疼痛,这一技术现今已很少采用。
当前,至少有两种常见的装置用于执行椎体间融合的椎间部分:第一种是撑开装置,而第二种是椎体间融合装置,通常称为融合笼(cage)。融合笼可作为独立装置植入,或者作为环状融合术的一部分利用椎弓钉和椎弓棒植入。这一概念是导入这样的植入物,即,其会对塌陷的椎间盘进行拉伸并且使得神经根减压以允许载荷分享来加强骨形成,并且这一概念是植入足够小的装置而使得植入具有最小的牵引和神经牵动。
一般的椎体间融合过程中,首先从椎体之间取出一部分的椎间盘。这可通过直接打开法或者微创法进行。可使用椎间盘刨削器、垂体咬骨钳、刮匙、及/或椎间盘刮削器来去除髓核(nucleus)以及前路椎间环(anterior annulus)或后路椎间环(posterior annulus)的一部分,以允许植入和进入内椎间盘隙。撑开装置插入经清除的椎间盘隙以增大椎间盘隙,并且通过致动撑开装置而隔开椎体。增大椎间盘隙是重要的,因为这也打开了神经根所在的椎孔。在撑开处理过程中,还有一点很重要,就是不过分撑开椎间小关节。然后将椎间融合装置插入被撑开出的空间,并且可将诸如自体移植物之类的骨生长因子,带有骨形态发生蛋白的胶原蛋白海绵,或者其它骨增强物质放入(在融合装置插入椎间盘隙之前或之后)椎间融合装置中,以增进椎体的融合。
可通过后方入路法、前方入路法、斜方入路法、及侧方入路法进行椎间融合与撑开。各种方法都有其自身的解剖学上的挑战,但通用的概念是颈胸椎或腰椎中对相邻的椎骨进行融合。业已采用多种材料制造了所述装置。所述材料包括尸体松质骨、碳纤维、钛、及聚醚醚酮(PEEK)。并且,所述装置可制造为不同的形状,诸如,豆形、足球(football)形、香蕉形、楔形、及螺纹圆柱笼形。
对于用于椎体融合与撑开这两者的装置来说,重要的是它应足够小以便于插入椎间隙,并且应足够高以保持椎间盘隙的正常高度。使用无法扩张至足够高度的小号装置可能会导致相邻椎骨之间的融合不足,以及使得病患发生进一步的并发症,如该装置移入椎间盘隙或者从椎间盘隙挤出。解决这些问题需要连续使用不同尺寸的多种装置,以将椎间盘隙扩张适当的量,这增加了执行治疗过程所需的时间,增大了与治疗过程相关的成本和风险。
因此,业界需要一种有足够强度的装置,从而能够从小到足以在一开始配合进入椎间盘隙的初始小尺寸撑开至足以重建和维持椎间盘隙的正常高度的高度。
发明内容
根据本发明多种实施例的用于椎体撑开和融合的改进方法和装置采用一或多个同轴螺纹齿轮套机构。多种实施例中,同轴螺纹齿轮套机构包括带有螺纹外表面的柱件,及配置为围绕所述柱件的相应套筒,所述相应套筒包括与所述柱件的螺纹外表面接合的螺纹内表面以及齿轮外表面。驱动机构可配置为与所述套筒的齿轮外表面接合,使所述装置撑开。
一实施例中,提供了一种同时用于椎间盘隙的椎间撑开和融合的装置。所述装置可包括第一支承面和第二支承面,其间设有至少一个同轴螺纹齿轮套机构。所述同轴螺纹齿轮套机构包括:柱件,所述柱件带有从所述支承面中的一个向内凸出的螺纹外表面;及配置为围绕所述柱件的相应套筒。所述套筒可从另一所述支承面向内凸出并且具有齿轮外表面和配置为与所述柱件的螺纹外表面接合的螺纹内表面。所述装置还可包括驱动机构,所述驱动机构具有配置为与所述套筒的齿轮外表面接合并且驱动所述套筒的齿轮外表面,这使得撑开所述第一和第二支承面。
另一实施例中,一种椎体间撑开和融合方法包括将可撑开椎体间融合装置植入椎间盘隙中。这样插入所述装置,即,使得第一支承面与椎间盘隙的上椎骨的端板接合,并且第二支承面与所述椎间盘隙的下椎骨的端板接合。所述支承面之间设有至少一个同轴螺纹齿轮套机构,其包括螺纹柱件,以及具有与所述螺纹柱件相配合之内螺纹和与驱动机构相配合之外齿轮的相应套筒。所述方法包括通过操作所述驱动机构以使得所述套筒相对于所述柱件旋转而将所述装置从压缩状态撑开至扩张形态,藉此使得所述第一支承面相对于所述第二支承面扩张。
本发明的上述内容并不意欲描述各个所述实施例或本发明的所有实现。这一发明内容代表本发明某些方面的简化概述,以帮助对本发明有基本的理解,并且不意欲表示本发明的关键或决定性的组成部分,或者界定本发明的范围。
附图说明
结合附图,参考下文对本发明的多种实施例的详细描述,可更完整地理解本发明,其中:
图1A为根据本发明实施例的处于压缩形态的可撑开椎体间融合装置实施例的立体图;
图1B为处于扩张形态的图1A所示可撑开椎体间融合装置的立体图;
图1C为图1A所示可撑开椎体间融合装置的分解图;
图1D为图1A所示可撑开椎体间融合装置的部分剖视图;
图2A为根据本发明实施例的可撑开椎体间融合装置的部分侧视图;
图2B为图2A所示可撑开椎体间融合装置的部分侧视图;
图3A为根据本发明实施例的可撑开椎体间融合装置的部分侧视图;
图3B为图3A所示可撑开椎体间融合装置的部分侧视图;
图4A为根据本发明实施例的可撑开椎体间融合装置的部分俯视图;
图4B为图4A所示可撑开椎体间融合装置的部分俯视图;
图5A为根据本发明实施例的插入工具和可撑开椎体间融合装置的立体图;
图5B为根据本发明实施例的插入工具和可撑开椎体间融合装置的立体图;
图5C为根据本发明实施例的插入工具和可撑开椎体间融合装置的立体图;
图5D为根据本发明实施例的插入工具的部分立体图;
图6A为根据本发明实施例的可撑开椎体间融合装置的侧视图;
图6B为图6A的可撑开椎体间融合装置沿纸面向内观察的侧面剖视图;
图7A为根据本发明实施例的可撑开椎体间融合装置的前视图;
图7B为图7A所示可撑开椎体间融合装置沿线7B-7B的剖视图;
图8A为根据本发明实施例的可撑开椎体间融合装置的前视图;
图8B为图8A所示可撑开椎体间融合装置沿线8A-8A的剖视图;
图9A为根据本发明实施例的可撑开椎体间融合装置实施例的分解图;
图9B为图9A所示可撑开椎体间融合装置的立体图;
图9C为图9A所示可撑开椎体间融合装置的前视图;
图9D为图9A所示可撑开椎体间融合装置沿图9C的线9D-9D的剖视图;
图10A为根据本发明实施例的可撑开椎体间融合装置实施例的分解图;
图10B为图10A所示可撑开椎体间融合装置的立体图;
图10C为图10A所示可撑开椎体间融合装置的仰视图;
图10D为图10A所示可撑开椎体间融合装置沿图10C的线10D-10D的剖视图;
图11A为根据本发明实施例的可撑开椎体间融合装置实施例的立体图;
图11B为图11A所示可撑开椎体间融合装置的前视图;
图11C为图11A所示可撑开椎体间融合装置沿图11B的线11C-11C的剖视图;
图11D为沿图11B的线11D-11D的图11A所示可撑开椎体间融合装置的剖视图;
图12A为根据本发明实施例的可撑开椎体间融合装置的立体图;
图12B为图12A所示可撑开椎体间融合装置的侧视图;
图13A为根据本发明实施例的可撑开椎体间融合装置的立体图;
图13B为图13A所示可撑开椎体间融合装置的侧视图;
图14A为根据本发明实施例的可撑开椎体间融合装置的立体图;
图14B为图14A所示可撑开椎体间融合装置的侧视图;
图15为根据本发明实施例的一对可撑开椎体间融合装置的立体图;
图16A为根据本发明实施例的处于压缩形态的可撑开装置实施例的俯视图;
图16B为处于扩张形态的图16A所示可撑开装置的俯视图;
图17A为根据本发明实施例的可撑开装置实施例的立体图;
图17B为图17A所示可撑开装置的部分切去图;
图18A为根据本发明实施例的可撑开装置实施例的立体图;
图18B为图18A所示可撑开装置的部分视图;
图18C为图18A所示可撑开装置的部分视图;
图18D为图18A所示可撑开装置的部分视图。
尽管本发明可进行多种变化及代替形式,具体细节在附图中以示例形式示出并且下文将予以详述。然而,应理解,并不意欲将本发明限制为所述的具体实施例。相反,本发明意欲涵盖其实质和范围之内的所有修改,等同物及代替物。
具体实施方式
在如下的本发明详细描述中,给出了许多具体细节,以便于充分理解本发明。然而,本领域的技术人员应认识到,本发明可实施为不具有这些具体的细节。相反,未对公知的方法、过程及组件做详细描述,以免不必要地混淆本发明的多种实施例所代表的方面。
参考图1A~1C,示出了根据本发明实施例的可撑开的椎体间融合装置100,其适于植入病患的椎间盘隙。图1A示出了处于完全压缩形态的装置100,图1B示出了处于完全扩张形态的装置100,图1C示出了装置100的分解图。
装置100包括具有支承面102的第一部件110和具有支承面104的第二部件150,支承面102配置为与椎间盘隙的上椎骨或下椎骨中的一个的端板交界,并且支承面104配置为与上椎骨或下椎骨中的另一个的端板交界。一实施例中,支承面102和104可包括具有纹理(诸如由波形114提供)的表面,以与椎骨端板产生摩擦从而防止装置100意外挤出。使得波形114的底部的半径和波形114的顶部宽度为最大,以在提供波形设计(可减小装置100从椎间盘隙挤出的倾向)的同时使得切口因素(notch factor)为最小并且减小应力。部件110和150中的一个或两者都可包括穿过所述部件的开孔173和153,以便于骨头经过装置100生长。其它实施例中,可使用凝胶,橡胶,或其它可复制椎间盘髓核并且增强所述装置在压缩、剪切、及扭力负载条件下的强度的顺应材料。或者,可在各部件110和115上设置大致实心的表面,形成有纹理或经蚀刻的表面,形成有划痕或凹口的表面,或者带有多个开孔的表面。
装置100还可包括一对同轴螺纹齿轮套机构,所述机构包括从第一部件110延伸的螺纹柱件111和112,和配置为围绕所述柱件111和112的一对螺纹齿轮套120和130。螺纹柱件111和112具有界定在其外表面上的螺纹113和115。螺纹齿轮套120和130可具有配置为与螺纹柱件111和112的螺纹113、115交界的内部螺纹122和132,以及外螺纹121和131。一实施例中,一个齿轮套120的外螺纹121和内螺纹122这两者位于另一齿轮套130的螺纹131和132的另一侧。齿轮套120和130的外螺纹121和131可具有切入螺纹的轮齿124和134。一实施例中,轮齿124和134并不切入至螺纹121和131的根部(或者较小的直径),以使得螺纹的强度为最大。压缩形态下,螺纹齿轮套120和130可配合在第二部件150的齿轮套开孔161和162中。开孔161和162可包括与螺纹齿轮套120和130的外螺纹121和131啮合的螺纹部151和152。一实施例中,齿轮套开孔161和162一直延伸穿过第二部件150的支承面104。一些实施例中,如图所述,螺纹齿轮套120和130为大致实心的。其它实施例中,螺纹齿轮套可包括一或多个穿过所述套的槽,以减轻重量并且节约材料,或者促进骨内生长。
装置100可利用穿过装置100中的蜗杆孔154的蜗杆140进行扩张。蜗杆140可具有相对的第一螺纹部142和第二螺纹部141,它们配置为通过齿轮套开孔161和162的螺纹部151和152上的一对孔157和158与螺纹齿轮套120和130的具有轮齿124和134的外部螺纹交界。蜗杆140的各端可包括六角形部(hex)143和144以允许蜗杆由传送系统(未示出)进行驱动。这类传送系统在驱动蜗杆140时可安装在装置100的螺纹孔156A或156B内以使传送装置稳定。装置100的两端可设有六角形部143,144和内螺纹孔156A和156B,这样装置100可从任意一端插入并且对其进行驱动,或者装置100可仅在其一侧包括六角形部和内螺纹孔,从而限制为仅可从单个方向插入并且撑开所述装置。下部件150还可包括一或多个位于蜗杆孔154上方的扇形凹口(scallops)155,其在提供增大的强度和厚度的同时仍然允许螺纹齿轮套120和130能够旋转。
通过图1D所示的可撑开的椎体间融合装置100的部分剖视图,可看出所述装置如何以多个同轴螺纹齿轮套机构作为伸缩机构,该伸缩机构利用螺纹柱件111和112、螺纹齿轮套120和130、及蜗杆140使得第一部件110和第二部件150相对扩张。通过逆时针旋转六角形部144从而使蜗杆140逆时针旋转,蜗杆140的第一螺纹部142朝向六角形头部144拉动螺纹齿轮套130的轮齿134。这使得齿轮套130沿着内螺纹152从第二部件150向上平移。随着齿轮套130一边旋转一边向上平移,从第一部件110延伸出的螺纹柱件112(其无法旋转)也相对于齿轮套130和第二部件150向上平移。通过齿轮套130的相匹配的内螺纹132驱动螺纹柱件112的旋向相反(opposite handed)的外螺纹115而导致所述第二个平移。利用相反旋向的具有外螺纹121和内螺纹122的螺纹齿轮套120、具有外螺纹113的柱件111和蜗杆140的第二螺纹部141,可在所述装置的另一侧形成同样的机构。
由于各装置的相同组件的螺纹都形成为旋向相反,因此蜗杆140一侧的螺纹142拉动螺纹齿轮套130的轮齿134,同时蜗杆140的另一侧的螺纹141拉动另一齿轮套120的轮齿124,或者反过来,这取决于蜗杆140的旋转方向。可通过蜗杆140以紧张或压缩的形式传导由螺纹齿轮套120和130施加在蜗杆140上的这些反力。因此,蜗杆140并不随着装置100的扩张或收缩而基本上被驱动进入或离开蜗杆孔154。这样的优点在于不需要设置销或者其它限位器来对螺杆进行限位并且平衡所述装置中的力。此类销会成为过度磨损的点,而这会缩短装置的寿命。一些实施例中,可使用销来防止能够轴向拉动或推动蜗杆140,这会导致所述装置卡死。
蜗杆驱动的代替驱动机构包括压电致动器,以及任何的动量施加碰撞机构或形态。此外,蜗杆之类的驱动机构可作为传送系统的组成部分。此实施例中,两个螺纹齿轮套的外螺纹可为相同旋向,并且蜗杆通过蜗杆孔拧入处于压缩状态的装置中。随着蜗杆被转动,传送系统(而不是销)会约束蜗杆的轴向位置,从而撑开装置。一旦所述装置到达所需高度,可将蜗杆拧出蜗杆孔,并且可通过拧入螺纹锁定蜗杆而将装置锁定在适当位置。锁定蜗杆可具有额外的螺纹或卡合部件以使其永久地或可取下地附接至装置。锁定蜗杆可由PEEK之类的射线透明材料(radio transparent material)制成,因此可允许透过蜗杆进行成像。锁定蜗杆的强度仅需足以防止螺纹齿轮套转动进入或掉出所述装置,并且其强度无需强到使得所述装置撑开。只要所述装置保持必要的刚性,可通过沿所述装置的长度在下部件中开孔的任意一侧,去除所述下部件侧边的一部分而形成较大的射线透明窗。
现参考图2A和2B,示出了第二部件150的内螺纹部151和152与螺纹齿轮套120和130的轮齿124和134之间的较佳配合。由于通过蜗杆朝向第二部件150的内螺纹151和152插入轮齿124和134,因此通过部件之间的支承面163和164平衡轮齿124和134与螺纹151和152之间的负载,这导致装置100能够撑开较大的负载。轮齿124和134与内螺纹151和152之间的配合与图3A和3B所示的配合进行比较。这些图中,当朝向第二部件150’的内螺纹151’和152’插入螺纹齿轮套120’和130’的轮齿124’和134’时,并不是通过如图2B中的支承面来平衡力,而是通过由内螺纹151’和152’施加到轮齿124’和134’上的力来平衡。这可导致使得轮齿124’和134’起楔的作用,并且卡死在内螺纹151’和152’上,这会极大地减损所述装置撑开较大负载的能力,并且使得所述装置对组件之间的摩擦更敏感。视需要,可使用硅润滑剂之类的液体或气体润滑剂来减小所述机构中的摩擦。盐溶液也可用作润滑剂。
应注意,尽管附图所示的螺纹俱为呈凸出的螺旋肋部形式的螺纹,然而本发明的“螺纹”亦可指其它任何将旋转力转换为平移运动或纵向运动的机构。例如,一些实施例中,可由轴承的再循环结构或者螺旋结构,或其它任何低摩擦结构(诸如相配合的磁体)来形成螺纹。
一实施例中,完全压缩形态下,装置100在支承面102与104之间的高度为6.5毫米,并且最大的完全撑开高度为12毫米,由此,相对于装置的初始高度,撑开量非常大。所述最大高度由所述装置能满足可植入椎体间融合装置所需的动态压缩、剪切、扭转要求时的最大的高度所限定。决定这一高度的变量包括螺纹齿轮套的宽度(其受限于所述装置的所需宽度)和制造所述装置的材料。就所述装置用的材料而言,疲劳性能较高的材料允许即使宽度较窄所述装置的最大高度也能较大。一实施例中,所述装置由钛制成。为了增强强度特性或者增强射线可透特性(取决于材料),所述装置还可由钴铬合金,MP35N,或PEEK制成。X射线透明性是理想的特性,因为其允许透过所述装置对正在融合的骨进行成像。一实施例中,所述装置可设计为,在压缩形态下,螺纹齿轮套通过第二部件的支承面凸出,从而能够撑得更开。为了容纳植入时的所述装置,可在相邻的椎骨端板之间切出用以容纳齿轮套的凸出部的开孔。
一旦被撑开,装置100不需要锁定机构来保持位于体内的所需高度。这是因为,当被向后驱动时,所述装置具有出非常高的齿轮比,这样,即使系统内只有最小的摩擦也能压制可能施加于所述装置的任意量压缩,扭转,或剪切负载。在剪切、扭转、及压缩的动态测试中,所述装置高度的最大改变量为约0.01毫米。由于装置100可以1微米的数量级保持在沿螺纹齿轮套的任何一点上,因此装置100也具有非常高的高度控制分辨度。
一实施例中,螺纹齿轮套120和130上的外螺纹121和131和轮齿124和134可为大致的梯形。一实施例中,所述螺纹为8毫米乘1.5毫米的梯形公制螺纹。梯形的设计能达成相对较大的轮齿尺寸,因此达成较大的其上分布撑开负载的面积。此外,通过精确制造,螺纹齿轮套120和130上的多个轮齿124和134可沿着压力角ANG同时与蜗杆140啮合,如图4A和4B所示。要在达成最小装置尺寸的同时提供最大的撑开量和负载能力,关键的是在齿轮套120和130的多个轮齿和蜗杆140上分布撑开负载。
图5A(压缩形态)、5B(部分撑开形态)、及5C(完全撑开形态)示出了用于植入根据本发明实施例的可撑开椎体间融合装置的传送系统200。传送系统200还包括致动工具300以使得撑开开始。
为了撑开装置100,首先通过传送轴203的端部201上套筒起子将装置的六角形部143或144联结至传送系统200。为了更稳固地附接装置100和传送系统200,可将传送轴204的螺纹端202拧入装置100的第二部件150中的螺纹孔156A或156B。然后可使用传送系统200通过标准的经椎间孔入路椎体间融合术(TLIF)或后路腰椎椎体间融合术(PLIF)将装置100插入人体。另一种方法为经过侧腹膜后道的外侧椎体间融合(lateral interbody fusion)。由于使用把手213插入传送系统200,因此其可对装置100的位置进行导向。
传送系统200包括位于传送轴204的近侧端的六角形部215和周向槽214,并且还包括位于传送杆203的末端的六角形部和周向槽(未示出)。一旦将装置100放置在椎间盘隙中,可通过使得致动工具300的内六角形套筒起子与传送轴203和204的末端上的六角形部接合,而将致动工具300连接至传送系统。一些实施例中,致动工具300中的内卡环或周向弹簧可与传送杆203上的周向槽接合,以保证致动工具300不会在使用时意外分开。
通过转动致动工具300,使用者可沿着传送轴203将转矩向下传递至将装置100撑开的蜗杆104。随着传送杆203被转动,滑块206沿轴203上的螺纹209前进。随着装置100的扩张,可通过滑块206沿传送轴204的位置利用多个基准标志208在传送系统200上表示出装置100的高度,如图5D最好地示出。标志208可沿传送轴204隔开任何理想的间隔,并且滑块206可包括观察槽207,随着滑块206靠近标志208而可通过观察槽208更完整地观察这些标志。一实施例中,各标志208可代表1毫米的撑开高度。
传送系统200可配置为,当装置100到达其最大所需高度时,滑块206接靠挡块205,从而滑块206无法再前进,由此限制装置100的高度。通过允许传送系统200来限制扩张,任何由过度转矩所造成的损害会立即在传送系统200中显示出来,这样装置100就不会受到损害。另一实施例中,将螺纹齿轮套120和130中的一个上的轮齿124和134中的两个焊接在一起,这样,这两个轮齿在装置100已到达其最大所需高度时与蜗杆140结合在一起,由此,装置100可限制其自身的扩张。类似地,其他实施例中,可省略齿轮124和134中的一个或多个,或者可将尺寸较小的杆插入两个轮齿之间的间隙空间以限制装置的扩张。
一实施例中,可将用于向杆204施加转矩的杠杆附接至杆204的末端处的六角形部215。可这样确定杠杆的形状和方位,即,当装置100适当地与传送系统200接合时,所述杠杆的位置允许触碰到驱动轴203,而当所述装置未适当地接合时,所述杠杆不允许触碰到驱动轴203。另一实施例中,滑块206可包含在把手213中,以减小传送系统200的长度。另一实施例中,可绕杆203和204中的一个设置能够承载扭转负载的管,以增加传送系统的结构上的刚性。可在所述管上附接尺寸较小的底座,以附加地支持传送系统通过所述装置承载并且传递扭转负载,并且将所述扭转负载承载并且传递至所述装置。另一实施例中,传送系统200的杆的形状可呈曲线形或者带有切口(bayonet),以允许通过微创的系统和工作通道进行视觉观察。
致动工具300还包括允许使用者用单根手指旋转致动工具300的凹槽或圈,以及/或者使用者握住以转动致动工具300的较大握持表面301。一实施例中,所述圈可与滑动面或支承面成直线,以使得所述圈能够容易地绕使用者的带手套的手指旋转。致动工具300还可包括设计用以承受植入锤的冲击的较宽的面303。致动工具300上还可包括凹槽302,这样,当装置100被植入时,可使得使用者更好地观察装置100。致动工具300可同时横跨传送轴203和204,并且可在传送系统200的把手213的上方延伸,或者容纳所述把手213。另一实施例中,装置100并不是由手动致动工具300驱动,而是可由气动钻或电钻或机动化螺丝起子机构之类的动力致动实现方式来驱动,某些实施例中,可通过这些实现方式来远程控制所述致动工具。
其他实施例中,手动或自动的致动工具利用所述装置中的传感器来将有关植入参数和环境的数据(例如,装置负载和肌张力)传输至操作者或操作系统以改进外科手术的过程和结果的性能。传送系统200可使用位于装置100上的小张力计及/或附接至传送轴203和204的负载传感器以及致动工具来测量植入和撑开过程中存在的负载。可通过位于传送系统200上的微控制器板来监视这些计量器及/或负载传感器,并且经由USB之类的标准接口或无线连接将信息反馈回监视计算机。这一信息可用于密切监视手术的过程,对即将发生的问题发出警告,并且改进以后的手术。若这些计量器未进行完全的桥接,可将这些计量器配置为在所述装置内进行半桥接,然后在装置外部完成桥接。可使用标准的信号调理放大器,以对信号进行激励和调理从而形成可测量的电压和电流输出。
一实施例中,装置100可具有加强的第二部件150,如图6A和6B所示。通过降低蜗杆孔154从而降低蜗杆140,这样,当装置100扩张至其完全高度时,蜗杆140与螺纹齿轮套130上的最靠近螺纹齿轮套130的底部136的全开轮齿(full geared tooth)134A啮合,由此可达成加强的第二部件150。这允许降低第二部件150的顶面166,从而允许第一部件110变得更厚,其强度也就变得更大,同时还可保持相同的起始高度。此外,这也允许第二部件150的顶面166与蜗杆孔154之间的材料168做得更厚。这一结构的另一个优点是,当所述装置完全撑开时,第二部件150上至少有一个完整的内螺纹152A与螺纹齿轮套134啮合。这一结构中,可在第二部件150的与蜗杆孔154(前文描述为位于第二部件150的这一侧的顶面166A)相对的一侧添加附加厚度167。这允许完全内螺纹152B在内螺纹152A相对的一侧上与螺纹齿轮套130啮合。通过使用位于两侧的完全螺纹来卡抓螺纹套筒,当所述装置承受剪切和扭转负载时,可有最大量的材料来抵挡这些负载,这使得结果应力为最小并且增长装置100的疲劳寿命。
图7A和7B示出了本发明的另一实施例,其中螺纹柱件111和112采用锯齿螺纹113A和115A(比较图7B中的螺纹113A与图1D中的螺纹113和115)。锯齿螺纹结构可使得负载承受螺纹面垂直于柱件111和112的螺旋轴线,这可增大所述装置的轴向强度。图8A和8B示出了另一实施例,其采用位于螺纹柱件111和112上的标准60度螺纹113B,115B。一般认为60度螺纹是工业标准,因此可利用通用的加工操作生产。这使得能够更快速和廉价地制造出装置。
现参考图9A~9D,另一实施例可撑开椎体间融合装置400包括一对在第一部件410和第二部件450之间延伸的螺纹齿轮柱件423,而不是前述分离的螺纹齿轮套120和130与螺纹柱件111和112。螺纹齿轮柱件423各自包括螺纹齿轮部421和柱部411。螺纹齿轮部421配合在第二部件450中的开孔461中,并且与蜗杆440和内螺纹451接合以使得装置400撑开。柱部411配合在第一部件410的开孔416中,并且可附接至垫圈418。当螺纹齿轮柱件423在装置400被致动时独立于第一部件410自由转动时,垫圈418使得第一部件410位于相对于螺纹齿轮柱件423的适当位置。由此,如图9C和9D所示,更厚的螺纹齿轮部421撑开第一部件410与第二部件450,同时柱部411保持在第一部件410的开孔416中。这使得装置400的轴向强度更大。
图10A~10D示出了另一实施例可撑开椎体间融合装置500,其允许对螺纹齿轮套520进行差分调节。各螺纹柱件511可包括与第一部件510中的弓形槽517相对应的弓形部515。相对应的弓形部515与弓形槽517所形成的螺纹柱件511与第一部件510之间的弓形界面允许第一部件510旋转,并且变得与第二部件550成角度。采用枢转销572的销接头可用于第一部件510与螺纹柱件511之间的一个界面保持固定,同时允许另一界面因存在弓形面而滑动。放置销570用于防止蜗杆540在撑开装置时滑出第二部件550。蜗杆540可为双部件蜗杆,包括具有第一螺纹部543的第一部546,以及具有配合在第一部546的杆547上的第二螺纹部544的第二部548。因此,这两个部分546和548可相互独立地旋转,各部分驱动独立的螺纹齿轮套520。由于各螺纹齿轮套520可独立地被啮合,因此它们的撑开量可为不同,从而形成成角度的第一部件510,如图10D所最清晰地示出。这一结构可适用于脊柱前凸或后凸的几何形状。视需要,可使用挠性接头或球窝接头或者圆柱体插座接头来代替第一部件550上的弓形槽517和柱件511的弓形面515。
图11A~11D示出了另一实施例可撑开椎体间融合装置600。装置600使用三个同轴螺纹齿轮套机构,各具有位于第一部件610与第二部件620之间的螺纹齿轮套620和螺纹柱件621。如图11C和11D所示,为了撑开所述装置,使得蜗杆驱动件640旋转,并且蜗杆驱动件640与其中一个螺纹齿轮套620啮合,从而使得所述齿轮套旋转。随着第一螺纹齿轮套620旋转,其与另两个螺纹齿轮套620啮合,从而使得他们旋转,并且使得所述装置600撑开。螺纹齿轮套620的旋转也会使得螺纹柱件621撑开,如前所述。使用三个同轴螺纹齿轮套机构可使装置沿轴向的强度增大,支撑椎体端板的表面积更大,以及具有更美观的几何形状。视需要,可对这三个撑开机构进行独立的致动,从而可以额外的自由度调整所述装置的表面。为了达成某些几何形状,驱动机构可能需要为挠性的,这种情况下,可实现为能够弯曲并且传递转矩的风箱或者螺旋激光切割驱动机构。更具体地,一个此类驱动机构可包围许多撑开机构,并且可仅用一个输入撑开各个撑开机构。另一实施例中,挠性驱动机构可用于独立致动多个驱动机构,从而以多个空间度来控制所述装置的部件。
图12A和12B示出了仅采用一个同轴螺纹齿轮套机构的可撑开椎体间融合装置700,所述齿轮套机构具有螺纹齿轮套720以及螺纹柱件721,以利用蜗杆740相对于第二部件750撑开第一部件710。装置700还可包括第一伸缩支撑件774和第二伸缩支撑件776。伸缩支撑件774和776用以保持第一部件710相对于第二部件750的相对旋转位置,从而使得螺纹齿轮套720可相对于第一部件710以及第二部件750这两者旋转,以撑开装置700。图13A和13B示出了另一变化的装置700,其采用多个从第一部件710和第二部件750延伸的钉(spikes)778,以在旋转方向上约束第一部件710和第二部件750。手术过程中,钉778接触相邻的椎骨端板,并且钉778本身固定至所述端板以防止第一部件710和第二部件750相对着旋转。图14A和14B示出了另一实施例。这一实施例仅包括第一部件710与第二部件750之间的螺纹齿轮套720,并且当利用蜗杆740的转动撑开装置700时,允许第一部件710与齿轮套720一起旋转。视需要,第一部件710可相对于螺纹齿轮套720自由旋转,以允许第一部件710与椎体的端板接合,并且不顶着椎体的端板旋转。
一实施例中,本文所述可撑开椎体间融合装置可由钛制成,并且传送系统的主要成分可为不锈钢。各相互抵靠着而滑动的机构的部件可为不同类型的常见材料。例如,第一部件可由具有高光滑疲劳性能的Ti 6Al 4V标准钛制成,而螺纹齿轮套可由具有高缺口疲劳性能的Ti 6Al 4V ELI制成。这一组合可使得各组件由于疲劳缺口因子而由较佳的材料制成,而其组件滑动设置的整个机构实现为不同的材料。
多种实施例中,可根据人体工程学确定装置的形状。装置可为多种形状,例如,矩形,肾脏形,或足球形。由于椎骨的端板趋向于呈稍微的凹面,肾脏形或足球形的装置可使得装置与椎体之间的接触为最大。所述装置的一端或两端也可为锥形以便于插入。这使得初始插入所述装置并且分开椎体所需的力为最小。此外,所述装置可沿其长度和宽度呈凸面,或者为双凸面。装置可根据需要使用该装置的病人的椎骨类型和体型构造为多种尺寸。
由于一些实施例中所述装置的不同组件可以不同的方法制作,因此可以多种方法制作装置。一实施例中,可使用螺纹铣削来制造装置中的多种螺纹。可使用线EDM来制作装置中的所有或者某些孔和开口。也可使用装配夹具和后处理步骤来使得所述装置具有精确的标准。
一些实施例中,撑开所述装置之后,可将自体移植物,骨形成蛋白,或骨增强材料之类的骨生长刺激剂传送入装置。一实施例中,在插入工具与所述装置分离之前,经由插入工具中的中空室传送骨生成刺激剂。椎体之间发生实时融合期间,所述装置支撑活体内(in-vivo)负载。
一实施例中,可对装置的表面进行处理,以使得表面粗糙度为最小,或者减小材料在体内的蚀损。粗糙表面或者蚀损斑可增大装置上的应力,而这会缩短疲劳寿命及/或降低疲劳强度。一实施例中,可对表面进行电抛光处理,以去除装置边缘的毛边,并且对表面进行抛光。另一实施例中,由于端板的粗糙表面有助于防止装置被意外挤出,因此不对表面进行处理。一实施例中,还可使用高弹性、不渗透的材料对所述装置进行涂覆以延长其疲劳寿命。具体地,不渗透材料可防止血液的腐蚀特性使得所述装置降解。另一实施例中,所述装置可由生物相容材料构成,这样涂覆就不是必须的。再一实施例中,所述装置可由设计为在治疗过程的某个选择阶段(例如,在骨融合之后)在体内降解的生物可降解材料制成。
多种实施例中,本文所述的装置可与多种骨生长刺激剂一起使用。一实施例中,可在所述装置的表面或内部装载3D预矿化丝素蛋白支架载体,以传送视需要与修饰骨髓基质细胞(bMSCs)混合的骨形成蛋白(BMP),以促进融合。其他实施例中,可使用壳聚糖复合3D纤维网支架或者明胶(gelatin)支架。所述装置还可通过在涂有粘附聚多巴胺薄膜以增大人体真皮细胞的附着性、活性和增生的钛合金基材上沉积固定化血管内皮生长因子(VEGF)而使用VEGF,以通过植入体周围的血管再形成来促进向融合骨的供血进展。一些实施例中,可使用诸如生物可降解PLGA等某些聚合物来制成VEGF用支架来增强新血管的生成和骨再生。一些实施例中,VEGF可与BMPs一起使用,以抑制BMPs促进骨生成的功能,从而允许所述装置继续随着时间的推移而进行调节。多种实施例中,可在所述装置上的支架内或者在所述装置周围的支架种入骨髓衍生干细胞、牙髓衍生干细胞、及脂肪衍生干细胞。支架也可由多种材料构成,包括聚酯(例如,聚乳酸-聚乙醇酸(polylactic acid-co-glycolic acid)或聚3-羟基丁酸脂-共-3-羟基戊酸脂(poly3-hydroxybuetyrate-co-3-hydorxyvalerate))、丝(例如,仿生的、基于丝素支架的磷灰石涂覆多孔生物材料)、水凝胶类(诸如聚己酸内酯(polycaprolactone)、与PEO或明胶共纺的聚ε-己内酯(polyepsiloncaprolactone)/胶原蛋白(mPCL/Col)、具有微米尺寸纤维的mPCL/Col网、及与Heprasil共喷的mPCL/Col微纤维)、及通过多种表面处理(诸如VEGF或磷酸钙涂覆)进行官能化的多孔钛和钛合金(诸如钛-铌-锆合金)。
一些实施例中,装置可包括适于将骨限制在植入体内部或其周围的结构。这一结构可包括微观矩阵或支架材料或切口和缺角(divot),或者装置本体中的其他类似部件。还可通过使用多孔材料来对骨进行限位,这样可将骨限位在材料的孔隙空间中。更宏观地,可形成延伸的部件。此类部件(例如周向护套)也可使得装置的扭转刚性加强。
一些实施例中,可将一个以上的根据本发明的可撑开椎体间融合装置植入椎间盘隙。如图15所示,一实施例中,可植入一对装置100,以使一个装置100的第二部件150的外表面104与另一装置100的第一部件110的外表面102直接接合。此结构可允许使用较小的接触通道来植入所述装置。一实施例中,两个装置的配合面102和104是平的。可同时或独立致动多个装置100。还可使得多个装置相互回弹,以使得两个驱动机构都位于中央。此外,所述装置还可配置为可相对于对方旋转或者伸缩,以允许调节所述装置的支承面的位置,从而与椎体的端板合适地接合,或者防止脊椎运动。
一实施例中,所述装置可使用杆和螺杆,作为附接至椎体的装配件的一部分。具体地,用杆和螺杆支撑脊柱的后路固定可与所述装置组合使用。一实施例中,杆和螺杆可附接至植入体,或者设计为与植入体啮合。另一实施例中,所述装置的部件可延伸,并且有效地翻折到相邻椎体的侧边上方,这样,可利用通过所述装置的部件沿基本平行于椎体端板所形成之平面延伸而放置的螺杆使得所述装置附接至椎体。其他实施例中,可使用支持骨生长的粘合剂将所述装置粘附至脊椎或者粘附在脊椎中。
另一实施例中,可撑开椎体间融合装置可包括利用弯曲部进行加强的端板,从而能够从前向后倾斜及/或左右倾斜。此外,可绕着所述装置的周部对至少一部分采用挠性材料的同轴螺纹齿轮套机构进行定向,以允许沿多轴进行倾斜。能够倾斜的装置的有利之处在于可使得装置具有更大的灵活度,可促进骨生长,可在端板的整个表面分配应力,并且允许装置适应个体脊椎的曲率。
一实施例中,可将所述装置放置在例如由丝制成的小尺寸袜状滑动件,并且可在其中填充骨。随着所述装置扩张且所述装置的体积增大,所述袜状滑动件可防止骨掉出植入体及/或允许将更多的骨从所述袜状滑动件内在植入体周围的空间导入植入体。这一袜状滑动件的一端可闭合,并且可在装置的植入期间附接至传送系统。可在植入之后的任何步骤将所述袜状滑动件从传送系统取下。
根据多种实施例的装置可用于多种椎间融合应用,例如包括,颈椎椎间融合、胸前路腰椎椎间融合(thoracic anterior lumbar)、经椎间孔腰椎椎间融合、极外侧腰椎椎间融合、及后路腰椎椎间融合。这些应用的多种植入过程实施例如下:
颈:使用自体移植物经由前路术将装置植入C3~C7节段。所述装置与辅助前路板固定装置一起使用。
经椎间孔腰椎:使用自体移植物经由后路术将装置从L2~S1节段植入。所述装置与辅助后路棒固定装置一起使用。
后路腰椎:使用自体移植物经由后路术将装置从L2~S1节段植入。植入两个装置;一个在椎间盘隙的左侧,而另一个在椎间盘隙的右侧。所述装置与辅助后路棒固定装置一起使用。
前路腰椎:使用自体移植物经由前路术将装置从L3~S1节段植入。所述装置与后路棒固定装置的辅助前路板固定装置一起使用。
极外侧腰椎:使用自体移植物经由侧路术将装置从T12~L4节段植入。所述装置与辅助后路棒固定装置一起使用。
另一实施例中,所述装置可在椎体置换中使用。因为骨折或瘤而切除椎体或多根椎骨之后,可撑开所述装置以对两根独立的椎骨进行搭桥。撑开的装置对切除后留下的空缺进行搭桥和支撑。所述装置可构造为不同的尺寸以适应颈椎骨、胸椎骨、及腰椎骨的尺寸差别。
再一实施例中,所述装置可用作棘突间撑开装置,如图16A和16B所示。装置800可经由微创系统放置在两个相邻的棘突801a和801b之间。所述装置可以收缩形态插入,以方便布置。一旦到了适当位置,可使用同轴螺纹齿轮套机构804将所述装置致动到扩张形态,以将椎骨锁定在撑开位置。可如前所述地配置所述同轴螺纹齿轮套筒机构804。所述装置可在与棘突801a和801b接触的点处具有抓齿800,以帮助将其固定在适当位置。
另一实施例中,所述装置可用于棘突间融合。所述装置可以收缩形态经由微创系统放置在两个相邻的棘突之间。一旦到了适当位置,可致动所述装置以将椎骨锁定在撑开位置。所述装置可具有螺栓锁定机构或类似的锁定结构以将所述装置锁定在撑开位置,并且通过棘突间对锁定板进行锁定。所述装置可外侧可具有夹持波纹或夹持部件,以帮助将其固定在适当位置。可在装置的开口空间放置自体移植物或骨融合增强材料。
另一实施例中,所述装置可用作用于骨质疏松骨的可撑开骨折减缓装置。可经由微创椎根弓法将所述装置插入端板骨折的下方。然后利用传送系统致动器对所述装置进行致动。一旦减缓骨折,则取出所述装置并且用丙烯酸骨水泥(Acrylic Cement)或者其他能够加强骨的骨填料填充空隙。
另一实施例中,所述装置可用于小平面关节置换。在切除肥大的小平面关节之后,可致动所述装置。利用椎弓根螺钉将各部件固定至相邻的椎骨。这允许类似于小平面关节的活动,并且防止不稳定。所述装置可为软融合装置系统的一部分,或者可与椎间盘置换装置一起使用。也可使用同轴螺纹齿轮套机构或者螺纹柱,以使得椎间盘置换装置是可扩张的。
另一实施例中,所述装置可用作带有肌力计和骨刺激器的可编程撑开笼。可将可编程微电机致动器装置植入所述装置中。所述装置在植入过程中撑开,并且可术后通过无线电频率通信装置提供力的读数。在装置植入时通过利用制动器装置撑开部件会改变所述装置的形状,这会导致脊柱前弯症、脊柱后凸、过分撑开、或撑开不足。一实施例中,使用电池装置为所述系统提供动力,并且还可形成用作骨刺激器的磁场。可将电池的寿命限制为较短的时间,诸如一周。所述装置的小范围移动可利用压电体或导电聚合物生成电能,以对电池,电容器,或其它此类功率存储装置充电。或者,可通过RF感应或者电容耦合结构对所述装置进行供电。
另一实施例中,所述装置可为自致动可撑开笼。可将所述装置插入处于塌陷状态的椎间盘隙中。一旦松开所述装置,其可缓慢地撑开至预设高度。
另一实施例中,所述装置可在颌面手术中用作下颌骨折用碎骨延长装置。所述装置可设计为具有窄的部件,所述部件具有带孔的垂直板,所述垂直板允许将各部件固定至近侧或远侧碎骨。可将所述装置致动至预设高度。这允许在碎骨丢失,发育异常,或发育不全的情况下允许缺损处的延长。
另一实施例中,所述装置可在整形手术中用作延长钉(Iengthening nail),以牵引长度较长的骨碎片。在带有骨丢失的整形骨折发生之后,可放置可扩展的延长钉以将骨延长。在若干天的时间内发生微米移动的延长。这一应用会涉及牵引装置插入在施加反牵引力的插入钉的移动部之间,提供骨延长。
另一实施例中,所述装置可用于置换手的指关节,脚的跖骨关节,或者跟距关节。这些关节可具有允许相邻骨的运动并且限制过度延伸或过度屈曲的植入体。
图17A和17B示出了根据本发明另一实施例的可撑开装置900,其包括带循环轴承的包络(enveloping)同轴螺纹齿轮套。装置900包括柱件910,包络同轴螺纹齿轮套920、蜗杆930、及壳体940。柱件910包括光滑外表面912和用于轴承913的加工出的螺旋滚道911。同样在包络同轴螺纹齿轮套920的内表面上加工出与容纳轴承913的螺旋滚道911所互补的螺旋滚道(未示)。同轴螺纹齿轮套920内表面还加工出一条通道,供轴承913随着柱件910相对于齿轮套920移动而循环。图17B将所述循环轴承标为轴承914。包络同轴螺纹齿轮套的外表面还包括用于循环轴承914的螺旋滚道921和包络螺旋齿轮922。蜗杆930具有配置为与齿轮套920的包络螺旋齿轮922啮合的螺旋螺纹。壳体940的内表面具有与螺旋滚道921相配合以保持轴承914的螺旋滚道(未示出),以及供循环轴承914随着同轴螺纹齿轮套920相对于壳体940移动而循环的通道。视需要,同轴螺纹齿轮套920可在所述齿轮套的内侧和外侧都设置循环轴承,并且所述循环通道可位于所述齿轮套的内部与外部之间,以便于装配和制造。
为了使装置900扩张,蜗杆930顺时针旋转以与包络螺旋齿轮922啮合,从而使得包络同轴螺纹齿轮套920旋转并且平移出壳体940。这同时使得柱件910平移(但不旋转)出包络同轴螺纹齿轮套920并且远离壳体940。轴承913和914使得包络同轴螺纹齿轮套920能以非常小的摩擦进行旋转,使得装置900具有非常高的机械利益,并且能以非常高的精度进行位移控制。使用包络螺旋齿轮922可使得蜗杆930与包络同轴螺纹齿轮套920之间的界面可承受实质较大的负载。
现参考图18A~18D,示出了采用根据本发明实施例的同轴螺纹齿轮套的另一可撑开装置1000。装置1000包括包络同轴螺旋齿轮1010、壳体1020、及蜗杆1030。包络同轴螺旋齿轮套1010的外表面包括具有一系列包络同轴螺旋轮齿1014的螺旋槽。所述螺旋槽可与壳体1020的内表面1022上的内螺纹1021配合,以允许装置1000承受轴向负载。另一实施例中,可将轮齿1014直接加工在包围同轴螺旋齿轮套1010的外表面。另一实施例中,包络同轴螺旋齿轮套1010的外表面可为平滑加工外表面,当所述外表面与壳体1020的内表面1022上的类似平滑支承面一起配置时,可起类似于支承面作用,从而使得装置1000可承受横向负载。
为了使装置1000扩张,使蜗杆1030旋转以与包络同轴螺旋轮齿1014啮合,从而使得包络同轴螺旋齿轮套1010相对于壳体1020旋转并且平移。一实施例中,内表面1010和中心孔1012可配置为包括类似于图17A和17B所描述的柱件910的柱件,从而加强所述装置的撑开。一实施例中,壳体1020的内表面1022上不设有螺纹1021,这样,包络同轴螺纹齿轮套1010的螺旋槽及/或轮齿1014使得齿轮套1010随着齿轮套1010的旋转而相对于壳体1030平移。这一结构中,无需包络同轴螺纹齿轮套1010与壳体1020之间的倾斜界面,蜗杆1030可承受任何的轴向负载。
本文描述了系统、装置、及方法的多种实施例。这些实施例仅以示例的方式给出,并且不意欲限制本发明的范围。此外,应理解,业已描述的多种实施例特征可以多种方式组合以产生多个附加实施例。此外,尽管描述了可用于所述实施例的多种材料、尺寸、形状、植入位置等,但还可利用之外的其它材料、尺寸、形状及植入位置等,而不脱离本发明的范围。
Claims (73)
1.一种可撑开的椎体间融合装置,其适于植入病人椎间盘隙中,包括:
第一支承面,配置为与所述椎间盘隙的上椎骨的端板接合;
第二支承面,配置为与所述椎间盘隙的下椎骨的端板接合;及
至少一个设在所述第一支承面与所述第二支承面之间的同轴螺纹齿轮套机构,所述同轴螺纹齿轮套机构包括:
柱件,所述柱件的从所述第一支承面与所述第二支承面其中之一向内凸出的部分上设有螺纹外表面;及
配置为围绕所述柱件的相应套筒,其包括:
螺纹内表面,其位于所述套筒的从所述第一支承面与所述第二支承面中的另一个向内凸出的部分上并且配置为与所述柱件的螺纹外表面接合;及
位于所述套筒的一部分上的齿轮外表面;以及
驱动机构,其具有配置为与所述套筒的齿轮外表面接合并且对所述套筒的齿轮外表面进行驱动的表面,
使得所述驱动机构的选择操作导致相对于所述椎间盘隙的上椎骨和下椎骨撑开所述第一支承面与所述第二支承面。
2.如权利要求1所述的可撑开装置,其中所述套筒的齿轮外表面的螺距定向大致与所述柱件的螺纹外表面的螺距定向和所述套筒的螺纹内表面的螺距定向相反。
3.如权利要求1所述的可撑开装置,其中所述第一支承面与所述第二支承面之间设有由共用驱动机构所驱动的一对同轴螺纹齿轮套机构。
4.如权利要求3所述的可撑开装置,其中所述同轴螺纹齿轮套机构中的一个的套筒的所述螺纹内表面和齿轮外表面的螺距定向与另一个同轴螺纹齿轮套机构的所述螺纹内表面和齿轮外表面的螺距定向大致相反。
5.如权利要求1所述的可撑开装置,其中所述驱动机构为蜗杆驱动件。
6.如权利要求3所述的可撑开装置,其中所述驱动机构为具有一对螺纹段的蜗杆驱动件,各螺纹段配置为与所述同轴螺纹齿轮套机构中的一个接合。
7.如权利要求1所述的可撑开装置,其中当所述驱动机构驱动所述套筒的齿轮外表面时,所述驱动机构沿平移方向保持静止。
8.如权利要求1所述的可撑开装置,其中所述第一支承面为第一部件的外表面且所述第二支承面为第二部件的外表面,并且其中所述套筒配合入所述第一部件或所述第二部件中与所述套筒从其凸出之支承面相对应的那一个部件的套筒开孔中,以使所述套筒的齿轮外表面与所述套筒开孔的内螺纹接合。
9.如权利要求8所述的可撑开装置,其中所述驱动机构通过所述套筒开孔的内螺纹中的孔与所述套筒的齿轮外表面接合。
10.如权利要求1所述的可撑开装置,其中所述套筒的一部分也通过所述第一支承面与所述第二支承面中的另一个向外凸出。
11.如权利要求1所述的可撑开装置,其中所述第一支承面与所述第二支承面中有至少一个包括适于将骨保持于其中的结构。
12.一种椎体间撑开和融合的方法,包括:
将可撑开椎体间融合装置插入界定在相邻椎骨之间的椎间盘隙中,所述可撑开装置包括配置为与所述椎间盘隙的上椎骨的端板接合的第一支承面、配置为与所述椎间盘隙的下椎骨的端板接合的第二支承面、及至少一个设在所述第一支承面与所述第二支承面之间的同轴螺纹齿轮套机构,所述同轴螺纹齿轮套机构包括螺纹柱件,以及具有与所述螺纹柱件相配合之内螺纹和与驱动机构相配合之外齿轮的相应套筒;并且
通过操作所述驱动机构以使得所述套筒相对于所述柱件旋转而将所述可撑开装置从压缩形态撑开至扩张形态,藉此使得所述第一支承面相对于所述第二支承面扩张,从而以相对于所述椎间盘隙的下椎骨的端板撑开所述上椎骨的端板。
13.如权利要求12所述的方法,其中所述操作所述驱动机构以使得所述套筒相对于所述柱件旋转的步骤使得相对于所述第二支承面撑开所述套筒,并且使得同时相对于所述第二支承面与所述套筒撑开所述柱件。
14.如权利要求12所述的方法,其中操作所述驱动机构的步骤包括旋转具有与所述套筒的外齿轮接合之螺纹段的蜗杆驱动件。
15.如权利要求12所述的方法,还包括将传送系统连接至所述装置,并且所述插入步骤包括使用所述传送系统来插入所述装置。
16.如权利要求15所述的方法,其中所述将传送系统连接至所述装置的步骤包括将所述传送系统的传送轴的端部连接至所述驱动机构。
17.如权利要求16所述的方法,其中所述撑开所述装置的步骤包括旋转所述传送轴以使所述驱动机构旋转。
18.如权利要求12所述的方法,其中所述撑开所述装置的步骤包括撑开所述装置直至所述传送系统的高度表示机构表示出所述装置业已扩张至所需高度。
19.如权利要求18所述的方法,其中所述高度表示机构包括高度限制机构,所述高度限制机构适于防止所述装置扩张超过预定的最大高度。
20.一种撑开装置,包括:
第一支承面;
第二支承面;及
至少一个设在所述第一支承面与所述第二支承面之间的同轴螺纹齿轮套机构,所述同轴螺纹齿轮套机构包括:
螺纹柱件;及
具有外齿轮以及与所述螺纹柱件相配合之内螺纹的相应套筒;及
驱动机构,其与所述套筒的外齿轮相配合以使得所述螺纹柱件和所述相应套筒撑开所述第一和第二支承面。
21.如权利要求20所述的可撑开装置,其中所述套筒的外齿轮的螺距定向与所述螺纹柱件和所述套筒的内螺纹的螺距定向大致相反。
22.如权利要求20所述的可撑开装置,其中所述第一支承面与所述第二支承面之间设有由一个共用驱动机构所驱动的一对同轴螺纹齿轮套机构。
23.如权利要求22所述的可撑开装置,其中所述同轴螺纹齿轮套机构中的一个的套筒的所述内螺纹和外齿轮的螺距定向与所述另一个同轴螺纹齿轮套机构的所述内螺纹和外齿轮的螺距定向大致相反。
24.如权利要求20所述的可撑开装置,其中所述驱动机构为蜗杆驱动件。
25.如权利要求22所述的可撑开装置,其中所述驱动机构为具有一对螺纹段的蜗杆驱动件,各螺纹段配置为与所述同轴螺纹齿轮套机构中的一个接合。
26.如权利要求20所述的可撑开装置,其中当所述驱动机构驱动所述套筒的外齿轮时,所述驱动机构沿平移方向保持静止。
27.如权利要求20所述的可撑开装置,其中所述第一支承面为第一部件的外表面且所述第二支承面为第二部件的外表面,并且其中所述套筒配合入所述第一部件或所述第二部件中一个部件的套筒开孔,以使所述套筒的外齿轮与所述套筒开孔的内螺纹接合。
28.如权利要求27所述的可撑开装置,其中所述驱动机构通过所述套筒开孔的内螺纹中的孔与所述套筒的外齿轮接合。
29.如权利要求27所述的可撑开装置,其中所述套筒的一部分延伸穿过所述第一部件或所述第二部件其中之一的外表面。
30.如权利要求20所述的可撑开装置,其中所述第一部件与所述第二部件中有至少一个包括适于将骨保持于其中的结构。
31.一种方法,包括:
提供可撑开椎体间融合装置,所述装置包括配置为与椎间盘隙的上椎骨的端板接合的第一支承面、配置为与所述椎间盘隙的下椎骨的端板接合的第二支承面、及至少一个设在所述第一支承面与所述第二支承面之间的同轴螺纹齿轮套机构,所述同轴螺纹齿轮套机构包括螺纹柱件,以及具有与所述螺纹柱件相配合之内螺纹和与驱动机构相配合之外齿轮的相应套筒;
提供指令以利用所述可撑开椎体间融合装置执行椎体间融合和撑开的程序,所述指令包括:
将处于压缩形态的所述可撑开椎体间融合装置插入界定在相邻椎骨之间的病人的椎间盘隙中,以使所述第一支承面与所述椎间盘隙的上椎骨的端板接合,并且使得所述第二支承面与所述椎间盘隙的下椎骨的端板接合;
通过操作所述驱动机构使所述套筒相对于所述柱件旋转而将所述装置撑开至扩张形态,藉此使得所述第一支承面相对于所述第二支承面扩张,从而以相对于所述椎间盘隙的下椎骨的端板撑开所述上椎骨的端板。
32.如权利要求31所述的方法,其中所述操作所述驱动机构以使得所述套筒相对于所述柱件旋转的步骤使得相对于所述第二支承面撑开所述套筒,并且使得同时相对于所述第二支承面与所述套筒撑开所述柱件。
33.如权利要求31所述的方法,其中操作所述驱动机构的步骤包括旋转具有与所述套筒的外齿轮接合之螺纹段的蜗杆驱动件。
34.如权利要求31所述的方法,还包括提供传送系统,并且所述指令还包括将所述传送系统连接至所述装置并且使用所述传送系统将所述装置插入。
35.如权利要求34所述的方法,其中所述撑开所述装置的步骤包括旋转所述传送系统的传送轴以使所述驱动机构旋转。
36.一种可放置在相邻的第一与第二椎体之间的尺寸可调节植入体,所述植入体包括:
第一部件,其尺寸和形状形成为与所述第一椎体接触;
第二部件,其尺寸和形状确定为与所述第二椎体接触;及
尺寸可调节的支撑件,其与所述第一与第二部件接合以提供所述第一和第二部件之间的可调节分离距离,所述支撑件包括共同致动的、同轴的第一和第二可轴向旋转接头,以提供所述可调节分离距离。
37.如权利要求36所述的植入体,其中所述支撑件包括套筒部件,所述套筒部件包括下列组中的一个:
内螺纹和包括多个叠合齿部的外螺纹;或者
外螺纹和多个叠合齿部的内螺纹。
38.如权利要求37所述的植入体,其中所述套筒部件的内螺纹与外螺纹中的一个与位于所述第一部件上或者连接至所述第一部件的配合螺纹啮合,以形成为所述第一接头;并且
其中所述套筒部件的内螺纹与外螺纹中的另一个与位于所述第二部
件上或者连接至所述第二部件的配合螺纹啮合,以形成为所述第二接头。
39.如权利要求38所述的植入体,其中所述第一部件的配合螺纹包括位于所述第一部件内部的螺纹腔,并且其中所述第二部件的配合螺纹包括设有螺纹的柱部件。
40.如权利要求39所述的植入体,其中所述柱部件的第一端可旋转地安装在所述套筒部件的内螺纹上,并且其第二端部固定安装至所述第二部件。
41.如权利要求37所述的植入体,其中所述外螺纹为第一旋向,而所述内螺纹为相反的第二旋向。
42.如权利要求37所述的植入体,其中通过去除所述螺纹的这样的部分而形成所述齿部,即所述部分上的所述齿部的叠合深度小于所述螺纹的根部深度。
43.如权利要求37所述的植入体,其中所述齿部包括梯形形状。
44.如权利要求37所述的植入体,其中所述外螺纹的间距不同于所述内螺纹的间距。
45.如权利要求37所述的植入体,包括配置为与所述套筒部件的齿部啮合的驱动部件。
46.如权利要求45所述的植入体,其中所述驱动部件的旋转使得所述套筒部件沿第一方向相对于所述第一部件轴向位移,并且使得所述柱部件沿所述第一方向相对于所述套筒部件轴向位移。
47.如权利要求36所述的植入体,其中所述支撑件包括第一和第二套筒部件,所述第一套筒部件可旋转地安装在所述第一部件内的第一螺纹腔中,并且所述第二套筒部件可旋转地安装在所述第一部件内的大致平行的第二螺纹腔中。
48.如权利要求47所述的植入体,其中所述第一套筒部件包括第一旋向的并且包括多个叠合齿部的外螺纹,以及相反的第二旋向的内螺纹;并且
其中所述第二套筒部件包括相反的第二旋向的且包括多个叠合齿部
的外螺纹,以及第一旋向的内螺纹。
49.如权利要求48所述的植入体,包括具有第一和第二螺纹段的驱动部件,所述第一螺纹段包括第一旋向的且可与所述第一套筒部件的齿部啮合的螺纹,并且所述第二螺纹段包括相反的第二旋向的且可与所述第二套筒部件的齿部啮合的螺纹。
50.如权利要求36所述的植入体,其中所述第二部件配置为从与所述第一部件相邻的第一位置移动至所述第一部件隔开的第二位置。
51.如权利要求50所述的植入体,其中所述第一位置处的高度小于或等于约6.5毫米,并且所述第二位置处的高度至少为12毫米。
52.如权利要求38所述的植入体,其中所述尺寸可调节支撑件的一部分延伸穿过所述第一部件或第二部件其中之一的外表面。
53.如权利要求38所述的植入体,其中所述第一部件与所述第二部件中的至少一个包括适于将骨保持于其中的结构。
54.一种可放置在相邻的第一与第二椎体之间的尺寸可调节植入体,所述植入体包括:
第一部件,其尺寸和形状形成为与所述第一椎体接触;
第二部件,其尺寸和形状形成为与所述第二椎体接触;及
尺寸可调节的支撑件,其与所述第一与第二部件接合以提供所述第一和第二部件之间的可调节分离距离,所述支撑件包括第一套筒或柱部件以及第二套筒或柱部件,各套筒或柱部件具有包括多个叠合齿部的外螺旋螺纹或包括多个叠合齿部的内螺旋螺纹中的一个;及
驱动部件,其配置为与所述第一和第二套筒或柱部件接合。
55.如权利要求54所述的植入体,其中所述驱动部件的旋转使得所述第一和第二套筒或柱部件沿第一方向相对于所述第一部件轴向位移。
56.如权利要求54所述的植入体,其中所述驱动部件包括第一和第二螺纹段,所述第一螺纹段包括第一旋向的且可与所述第一套筒或柱部件的齿部啮合的螺旋螺纹,并且所述第二螺纹段包括相反的第二旋向的且可与所述第二套筒或柱部件的齿部啮合的螺旋螺纹。
57.如权利要求54所述的植入体,其中所述第二部件配置为从与所述第一部件相邻的第一位置移动至与所述第一部件隔开的第二位置。
58.如权利要求57所述的植入体,其中所述第一位置处的高度小于或等于约6.5毫米,并且所述第二位置处的高度至少为12毫米。
59.一种适于植入病人椎间盘隙的可撑开椎体间融合装置,其包括配置为与所述椎间盘隙的上椎骨的端板接合的第一支承面和配置为与所述椎间盘隙的下椎骨的端板接合的第二支承面,所述装置的特征在于还包括:
至少一个设在所述第一支承面与所述第二支承面之间的同轴螺纹齿轮套机构,所述同轴螺纹齿轮套机构包括:
柱件,所述柱件的从所述第一支承面与所述第二支承面其中之一向内凸出的部分上设有螺纹外表面;及
配置为围绕所述柱件的相应套筒,其包括:
螺纹内表面,其位于所述套筒的从所述第一支承面与所述第二支承面中另一个向内凸出的部分上并且配置为与所述柱件的螺纹外表面接合;及
位于所述套筒的一部分上的齿轮外表面;以及
驱动机构,其具有配置为与所述套筒的齿轮外表面接合并且对其进行驱动的表面,
这样,所述驱动机构的选择操作使得相对于所述椎间盘隙的上椎骨和下椎骨撑开所述第一支承面与所述第二支承面。
60.如权利要求59所述的可撑开装置,其中所述套筒的齿轮外表面的螺距定向与所述柱件的螺纹外表面的和所述套筒的螺纹内表面的螺距定向大致相反。
61.如权利要求59所述的可撑开装置,其中所述第一支承面与所述第二支承面之间设有由一个共用驱动机构所驱动的一对同轴螺纹齿轮套机构。
62.如权利要求61所述的可撑开装置,其中所述同轴螺纹齿轮套机构中的一个的套筒的所述螺纹内表面和齿轮外表面的螺距定向与另一个同轴螺纹齿轮套机构的所述螺纹内表面和齿轮外表面的螺距定向大致相反。
63.如权利要求59所述的可撑开装置,其中所述驱动机构为蜗杆驱动件。
64.如权利要求61所述的可撑开装置,其中所述驱动机构为具有一对螺纹段的蜗杆驱动件,各螺纹段配置为与所述同轴螺纹齿轮套机构中的一个接合。
65.如权利要求59或61所述的可撑开装置,其中当所述驱动机构驱动所述套筒的齿轮外表面时,所述驱动机构沿平移方向保持静止。
66.如权利要求59所述的可撑开装置,其中所述第一支承面为第一部件的外表面且所述第二支承面为第二部件的外表面,并且其中所述套筒配合入所述第一部件或所述第二部件中与所述套筒从其凸出之支承面相对应的那一个的套筒开孔中,以使所述套筒的齿轮外表面与所述套筒开孔的内螺纹接合。
67.如权利要求66所述的可撑开装置,其中所述驱动机构通过所述套筒开孔的内螺纹中的孔与所述套筒的齿轮外表面接合。
68.如权利要求59所述的可撑开装置,其中所述套筒的一部分也通过所述第一支承面与所述第二支承面中的另一个向外凸出。
69.一种使用如权利要求59所述的可撑开装置进行椎体间撑开和融合的方法,包括:
提供所述可撑开装置;并且
提供利用所述装置进行椎体间融合和撑开的指令,所述指令包括:
将处于压缩形态的所述可撑开椎体间融合装置插入界定在相邻椎骨之间的病人的椎间盘隙中,以使所述第一支承面与所述椎间盘隙的上椎骨的端板接合,并且使得所述第二支承面与所述椎间盘隙的下椎骨的端板接合;并且
通过操作所述驱动机构以使得所述套筒相对于所述柱件旋转而将所述装置撑开至扩张形态,藉此使得所述第一支承面相对于所述第二支承面扩张,从而以相对于所述椎间盘隙的下椎骨的端板撑开所述上椎骨的端板。
70.如权利要求69所述的方法,其中提供操作所述驱动机构以使得所述套筒相对于所述柱件旋转的指令提供了使得相对于所述第二支承面撑开所述套筒并且使得同时相对于所述第二支承面与所述套筒撑开所述柱件的指令。
71.如权利要求69所述的方法,其中提供操作所述驱动机构的指令提供了旋转具有与所述套筒的外齿轮接合之螺纹段的蜗杆驱动件的指令。
72.如权利要求69所述的方法,还包括提供传送系统,并且所述指令还包括将所述传送系统连接至所述装置以及使用所述传送系统插入所述装置。
73.如权利要求72所述的方法,其中提供撑开所述装置的指令提供了旋转所述传送系统的传送轴以使所述驱动机构旋转的指令。
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PCT/US2010/042915 WO2011011609A2 (en) | 2009-07-22 | 2010-07-22 | Methods and apparatuses for vertebral body distraction and fusion employing a coaxial screw gear sleeve mechanism |
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