CN102014799A - 具有可扩展的固定装置的脊柱植入物 - Google Patents

具有可扩展的固定装置的脊柱植入物 Download PDF

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Publication number
CN102014799A
CN102014799A CN2009801061226A CN200980106122A CN102014799A CN 102014799 A CN102014799 A CN 102014799A CN 2009801061226 A CN2009801061226 A CN 2009801061226A CN 200980106122 A CN200980106122 A CN 200980106122A CN 102014799 A CN102014799 A CN 102014799A
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CN
China
Prior art keywords
implant
extensile
adjacent vertebral
retaining element
implant according
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Granted
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CN2009801061226A
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CN102014799B (zh
Inventor
R·T·格罗茨
R·A·普雷蒂
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Howmedica Leibinger Inc
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INNVOTEC SURGICAL Inc
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0009—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting thickness
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

本发明涉及一种脊柱植入物，其被构造成在相邻椎骨体之间展开。该植入物具有至少一个固定元件(18，19)，所述固定元件具有用以方便植入物展开的缩回构造和用以接合相邻椎骨体的表面并将植入物固定在两个椎骨体之间的伸展构造。优选地，植入物是可扩展的并且在其未扩展状态下具有小于神经孔尺寸的最小尺寸，植入物必须穿过该神经孔以在椎骨间空间内展开。一旦处于椎骨体之间的空间内，植入物就可以扩展以便接合相邻椎骨的端板，从而有效地牵引前部椎骨间盘空间、固定运动节段并阻止病理脊柱运动。可以矫正角畸形，并且恢复和保持自然曲率。

Description

具有可扩展的固定装置的脊柱植入物
【技术领域】
本发明涉及用于稳定椎骨运动节段(vertebral motion segment)的装置和方法。更具体而言，本发明的领域涉及一种具有固定元件的可扩展脊柱植入物以将植入物固定在椎骨间空间内，同时提供三维受控脊柱矫正以改进脊柱的椎骨体间牵引和融合。
【背景技术】
常规的椎骨间保持架(cage)或植入物的特征在于具有菜豆形本体，该本体通常在试用植入物形成路径之后从后部纵排地插穿过被牵引脊柱的神经孔(neuroforamen)。用于使体间(interbody)稳定的现有设备存在重大且明显的限制，这些限制包括无法对端板进行扩展和牵引，同时将设备固定以阻止设备与相邻的椎骨体之间的相对运动。目前的用于使体间稳定的设备包括静态隔离件，这些静态隔离件包括钛、PEEK和由VICTREX(Victrex USA Inc，3A Caledon Court；Greenville，SC 29615)生产的高性能热塑性聚合物、碳纤维或者可吸收聚合物。此外，目前的体间隔离件无法保持体间脊柱前凸并且会导致形成直的或者甚至脊柱后凸的节段，并且带来了“平背综合症(flatback syndrome)”等临床问题。椎骨端板之间的分离增加了神经元、特别是神经孔可利用的空间。现有的静态保持器无法可靠地增加神经元的空间。因此，需要提供一种脊柱植入物，其将会从后部提供椎骨体之间的用于神经元的空间，或至少能保持自然骨骼的轮廓以避免出现神经失用症(神经牵拉)或侵占。
常规的用于使椎骨体间稳定的设备包括在骨与设备的生物材料之间的不良界面(interface)。常规的静态体间间隔件在骨与生物材料之间形成了不牢固的界面。尽管此类植入物的表面通常设有一系列脊部或涂覆有羟基磷灰石，但这些脊部会平行于所施加的水平矢量或左右运动。即，植入物上的脊部或涂层对于施加到端板任一侧上的移动没有提供多少阻力。这样，由于植入物与宿主骨之间的运动，使得在同种异体移植物、钛和聚合物隔离件中普遍出现骨不连合(nonunion)。
【发明内容】
本发明总体上涉及一种用于在部分或完全取下椎骨间盘后插入在上部椎骨端板与下部椎骨端板之间的脊柱植入物。体现本发明特征的脊柱植入物容易被安装并能够以增加的拔出强度保持椎骨或关节节段，以在将植入物引入关节固定术骨块内的时间段将植入物固定损失的几率降到最小。
更具体而言，本发明特别涉及一种脊柱植入物，其具有接合或刺入椎骨端板并阻止移植后在植入物与椎骨端板之间的运动的一个或多个可伸展的固定元件。所述一个或多个可伸展的固定元件在植入物内具有收缩构造以便不会与植入物在椎骨体之间的插入相干涉，并且具有伸展构造，远端(distal tip)伸出植入物的表面以在移植后接合椎骨端板并且相对于相邻的椎骨体固定植入物的位置。固定元件可通过各种方式伸展，比如通过流体压力，例如液压流体；通过机械力，比如与旋转驱动部件或其它合适的装置进行螺纹连接。优选流体移置。固定元件的远端应当足够锋利以刺入椎骨端板内。
优选地，体现本发明特征的脊柱植入物是可扩展的脊柱植入物，比如于2006年9月26日提交的序号为11/535,432和于2007年3月28日提交的序号为11/692,800的共同未决申请中所述的选择性扩展的椎骨间保持器，其提供了相邻椎骨之间的椎骨间盘高度的恢复并且可提供多维的矫正性脊柱序列。优选地，该植入物具有用于接纳骨传导材料以促进紧随移植之后椎骨间空间内新骨的形成。
具有本发明特征的脊柱植入物具有包括第一压力施加部件(比如具有第一骨接合表面的端板)的基部、与该基部配合的至少一个可伸展的部件、以及具有第二骨接合表面的第二上部压力施加部件，该第二骨接合表面被联接至所述至少一个可伸展的部件。所述一个或多个可伸展的固定元件被构造成伸展穿过设置在第二上部压力施加部件中的通道并超出其骨接合表面以刺入相邻的椎骨端板内并且相对于椎骨体固定植入物。优选地，固定元件以可滑动方式布置在可伸展的部件内的凹部内。
体现本发明的特征的选择性扩展的椎骨间保持器(spine cage，SEC)或脊柱植入物特别适合从后部插入上部椎骨端板与下部椎骨端板之间，如前述序号为11/535,432和11/692,800的共同未决申请中所述。SEC具有允许容易展开的未扩展构造并且最短横向尺寸通常为约0.8至约1cm以便能够以侵入性最小的方式从后部在椎弓根之间插穿直径大约为1cm的工作空间。伸展的固定元件伸出第二压力施加部件的组织接合表面至少0.1cm，优选地至少0.25cm，以确保与椎骨体的端板进行适当接合或接触并且优选其刺入。
在一个优选实施例中，至少一个且优选SEC的可伸展的部件全部具有布置在可伸展的部件中凹部内的可伸展的固定元件。在本实施例中，植入物优选地被流体激活使得可伸展的部件在移植之后使SEC扩展并被适当定位在相邻的椎骨体之间。另外，固定部件还随同SEC的扩展或在SEC的扩展之后通过流体压力伸展。优选地，流体扩展借助于来自位于远离病人位置处的主缸或注射器的液压流体以实现多维的受控脊柱校正和SEC在适当位置的固定。也可以采用单独的缸或注射器。有利地，液压流体是受时间控制的可固化聚合物，比如甲基丙烯酸甲酯，该聚合物具有如众所周知具有可以通过配制适当添加催化剂来调节的粘性和固化时间。当聚合物固化时，该聚合物使伸展的可伸展的部件和扩展的固定元件硬化并且将它们固定地锁定在适当位置处以提供所需的前部/后部、中间/侧部、上部/下部脊柱矫正量。也可以采用可扩展的部件和/或固定元件的机械锁定。
一旦被插入椎骨端板之间，则植入物有利地借助于最小的力就可以产生扩展，该力是通过液压控制管线在远程施加的。植入物的扩展有利地比其未扩展高度大约20％至约100％，通常约60％。典型扩展在8mm植入物的情况下为约13mm，而在10mm植入物的情况下则为约16mm。
由于椎骨端板在一端(前端)处借助于非常类似于蛤壳的韧带被保持在一起，所以随着植入物抵靠椎骨端板扩展，可对垂直扩展量进行调节以形成所需的前部/后部矫正角度。
脊柱的左侧矫正和右侧矫正是通过植入物的两个或更多个可伸展的部件的不同垂直扩展而实现的。每个可伸展的部件优选地受到主缸或注射器的独立控制，该主缸或注射器位于体外(位于远离病人的位置处)且与辅助缸进行液压传递(hydraulic communication)以使活塞和顶板进行垂直和横向移动，以便从前部或后部、从中间或从侧部对脊柱畸形进行矫正，从而提供三维脊柱矫正。
使侵入性降至最小的小型插入工具既从后部插入未扩展的SEC又罩住了在主缸与辅助缸之间进行连通的液压管线。该插入工具还罩住了用于将液态或浆料态的骨移植材料连通至辅助缸并连通进入椎骨间空间内以便随后融合的管线。有利地，这些液压管线是小尺寸管道以允许可以采用高液压压力而不会出现管线破裂的危险。辅助缸和活塞的尺寸可以产生变化以便增加机械优点。
由于液压系统提供了机械优点，所以SEC在其未扩展的状态下具有最小化的尺寸和直径，该尺寸和直径小于制备的神经孔的直径。SEC因此可从后部被插入且被接合在相邻椎骨的端板之间以便有效地牵引椎骨间区域、恢复用于神经元的空间、稳定运动节段、并阻止病理节段的运动。该SEC通过形成刚性脊柱节段而促进了脊柱关节固定术。
该SEC使得能够将相对大量的骨生长传导剂或诱导剂包含在该SEC内部并与相邻骨直接连通，这是一个显著的优点。重要的是，这导致产生了比相邻骨和软组织失效力更大的固定力。
该液压控制系统通过使得外科医生能够在远离病人身体位置处施加控制力而在三维方向上扩展并调节脊柱植入物而提供了使侵入性降至最小的过程。优选地，该扩展是无限可调的以便提供各种高度和横向角度，且不限于增量位置。该植入物可用来促进融合，和/或矫正诸如脊柱侧凸、脊柱后凸和脊椎前移之类的畸形。
SEC及其插入方法的临床目标将神经根受损的侵入性风险降至最小、减轻了痛苦、改善了功能且使得可在融合手术之后对病人进行早期固定。固定元件将植入物保持在所需的位置直到愈合(融合或关节固定术)出现为止。此时，植入物被结合在骨内部且其作用变成静止作用。本发明的SEC提供了更多的内部和外部移植骨空间暴露程度、使得更易于实现定向插入同时更为安全、降低了对神经根和其它组织造成插入损伤的风险、且因此显著改善了中长期治疗效果。
因此，本发明的一个关键特征在于，实质上不可压缩的植入物可以在仅1cm工作空间内从后部插入椎弓根之间。植入物然后可被扩展至其原始插入尺寸的约100％至约200％，通常约160％，以便提供严格受控的全方位三维脊柱矫正。所述一个或更多个可伸展的固定元件或钉确保植入物在展开之后保持在适当位置。本发明的这些和其它优点将从以下详细描述并从示例性附图变得更加明显。
【附图说明】
图1描绘出体现本发明的特征的SEC在相邻的腰椎之间的安放情况。
图2是图1中所示的SEC处于展开之前的未扩展状态下的前部透视图。
图3是图2中所示的SEC的剖视图。
图4是类似于图2中所示的SEC处于扩展构造中的前部透视图。
图5是图6的SEC处于扩展构造中的剖视图。
图6是图5中所示的扩展的SEC在与椎骨体相邻位置处的部分剖视图，固定部件的尖端刺入椎骨体的表面。
【具体实施方式】
图1图示出在扩展构造中脊柱植入物或SEC 10在相邻的腰椎之间的位置。在插入脊柱植入物10之前以常规的方式实施了部分或完全的椎骨间盘切除术。SEC 10在其未扩展状态下被导入以使其能够在病人受外伤和神经根受伤的风险最小的情况下从后部插入。一旦就位，就可以使SEC10扩展以既提供中间脊柱矫正又提供侧部脊柱矫正。SEC具有约5至约15mm、通常约10mm的未扩展高度，并且可扩展至未扩展高度的至少130％至约180％。通常，SEC宽约9至约15mm，通常约12mm；并且长约25至约40mm，通常约28mm，以有利于从后部插入，并从而将病人受外伤和神经根受伤的风险降至最小。
图2-3图示出处于封闭或未扩展构造中的SEC 10，并且图4以剖面图或剖视图图示出处于扩展构造中的SEC 10以示出内部结构。
如这些图中所示，SEC 10具有基部12，该基部12具有压力施加端部件或板13，该压力施加端部件或板13具有用于接合相邻椎骨体的端面的表面14。可伸展的支承部件15和16与基部12配合。第二端压力施加部件或板17联接于可伸展的支承部件15和16，使得板17随同可伸展的支承部件15和16的伸展而移动。板17不但可以仅被固定于可伸展的支承部件中的一个，而且可与另一个可伸展的支承部件接合。每个可伸展的支承部件可具有固定于其上的单独端板。如图3中更详细地示出，可伸展的支承部件15和16设有以可滑动方式布置在可伸展的支承部件15和16的孔20和21内的固定元件或钉18和19。钉18和19设有扩大基部22和23，扩大基部22和23为孔20和21提供密封。该密封允许钉18和19通过使可伸展的支承部件15和16伸展的相同加压液压流体(未示出)而伸展。钉18和19设有尖远端22和23，尖远端22和23延伸穿过设置在端压力板17内的通道24和25，以确保这些钉与相邻椎骨体之间如图5中所示进行接触以便将SEC 10固定在相邻椎骨体之间的空间内。在图5中，SEC 10被示出处于扩展构造中。SEC 10具有中心腔体27，用于当SEC完全扩展时或者在扩展期间将骨移植材料灌入椎骨间空间内。
SEC的另外细节，比如液压管线和用于传输浆料态或液态骨移植材料的管线的附属装置、设备和液压流体传送附件等，可在于2006年9月26日提交的序号为11/535,432和于2007年3月28日提交的序号为11,692,800的共同未决申请中找到，在此通过引用将其并入。
由于椎骨端板在一端处借助于非常类似于蛤壳的韧带被保持在一起，所以可以对设备10抵靠相邻椎骨体的端板的扩展进行调节以形成所需的前部/后部矫正角度。
用来使SEC 10扩展以及使钉18和19伸展的液压流体可以有利地是受时间控制的可固化聚合物，比如甲基丙烯酸甲酯。如众所周知的，可以通过配制适当添加的催化剂来调节此类聚合物的粘性和固化时间。此类催化剂可以从LOCTITE Corp.，1001 Trout Brook Crossing，Rocky Hill，Connecticut 06067获得。当聚合物固化时，该聚合物使可伸展的部件15和16以及钉18和19硬化并将它们锁定在所需位置处以提供由医师确定的所需的脊柱矫正量。可以采用其它装置来将可伸展的部件和钉锁定在所需位置处。例如，可以在一个或多个活塞的孔、以及钉的一个或多个孔内设置弹簧致动的锁定指形件，这些锁定指形件当活塞或钉在其伸展后经过它们的相应部位时向外伸展。
可以理解的是，SEC，包括它的各种构件，应当由生物相容、基本上不可压缩的材料形成，比如钛，并且优选6-4型钛合金或者其它的将允许在病人体内长期布置的适当材料。
可伸展的部件15和16的伸展优选地是被单独控制，使得医师能够提供SEC矫正表面的受控角度。虽然在此仅描述了两个可伸展的部件，但SEC 10可以被设有三个或更多个单独的可伸展的部件，使得医师可对SEC伸展进行三维控制。
体现本发明特征的SEC10提供了多个优点，包括：冠状面畸形的校正；体间脊柱前凸的引导；以大于目前间隔设备的刚性提早固定体间空间；以及将SEC固定在椎骨间空间内的能力。这种提早稳定可以改善术后疼痛，排除对包括椎弓根螺钉的后期植入物的需要，并且提高关节固定术的成功率。重要的是，SEC提供了神经元可获得的空间的改善，同时改善脊柱前凸。当被灌入的骨诱导/骨传导骨移植材料进行愈合时，病人变得康复并且植入物变成惰性和静止态，被埋置在骨内且不再被需要。
尽管已结合目前被认为最实用也最优选的实施例对本发明进行了描述，但应该理解的是，本发明并不限于如上所述被披露的实施例和备选方案，而是相反地旨在涵盖被包括在以下权利要求的范围内的各种变型和等效设置。
例如，文中所述的SEC 10是通过液压流体进行扩展的。可以采用其它扩展装置。例如，可以采用螺丝机构来使SEC扩展并且使一个或多个钉伸展与相邻的椎骨表面接合。另外，有助于将SEC固定在椎骨空间内的钉在文中被描述为随同可伸展的支承部件延伸。但是，可以以可滑动方式将这些钉布置在单独的孔内并通过独立于可伸展的支承部件的扩展装置的装置进行伸展。
进一步地，SEC可以设有载荷或压力传感器，这些载荷或压力传感器记录由病人的椎骨端板施加在SEC的接合表面上的不同压力和压力密度以产生矫正信号，例如是通过计算机控制实现的，这种计算机控制例如由外科医生或受计算机控制的机构来使病人的脊柱重新对齐。本发明可进一步包括使这些调节实时且连续地响应于传感器信号的系统，从而使得植入物的形状发生变化以使病人的脊柱或机构重新对齐。优选地，这种系统被预想用来在植入物的安装期间设置活塞的位置。
此外，SEC无需被刚性地锁定在适当位置处，而是可以设有可屈服材料以提供SEC的端面的一些移动来接纳脊柱的移动。
尽管文中已示出和描述本发明的具体形式，但显然可对本发明作出各种改型和改进。可在文中引用的专利和申请中找到脊柱移植设备的另外的细节。以在文中未以别的方式进行披露为限，材料和结构可属于常规的设计。
此外，本发明的实施例的单独特征可能在一些图中被示出而在其它图中未被示出，但本领域的技术人员应该认识到，本发明的一个实施例的单独特征可以与另一实施例的任何或所有特征相结合。因此，本发明并非旨在受限于所示的特定实施例。因此，本发明旨在通过所附权利要求在现有技术许可情况下尽可能宽泛的范围来进行限定。
用语如“元件”、“部件”、“构件”、“设备”、“装置”、“部分”、“区段”、“步骤”和类似含义的词语当在文中使用时不应当被解释为调用了美国法典第35编第112(6)条款的规定，除非以下权利要求清楚地使用接以特定功能的用语“用于...的装置”或“用于...的步骤”而未参照具体的结构或具体的动作。在此通过引用并入以上提到的所有专利和所有专利申请的全文。

Claims (24)

1.一种用于安放在相邻椎骨体之间的空间内的脊柱植入物，其包括：
a.用于接合第一相邻椎骨体的一端的第一表面；
b.用于接合第二相邻椎骨体的一端的第二表面；
c.至少一个可伸展的部件，其被构造成使所述第一表面和所述第二表面中的至少一个从缩回构造伸展至与相邻椎骨体的一端接触的伸展构造；以及
d.至少一个可伸展的固定元件，其具有远端、缩回构造以及伸展构造，所述远端被构造成刺入相邻椎骨体的一端内，所述缩回构造在所述植入物内用以方便所述植入物在所述第一椎骨体与所述第二椎骨体之间展开，所述伸展构造用以使所述远端伸出所述第二表面以刺入所述第二相邻椎骨体的一端内并将所述植入物固定在所述第一相邻椎骨体与所述第二相邻椎骨体之间的空间内。
2.根据权利要求1所述的植入物，其中，用于接合第一相邻椎骨体的一端的所述第一表面包括基部部件并且用于接合第二相邻椎骨体的一端的所述第二表面包括压力施加部件以伸展所述第一表面和所述第二表面中的至少一个。
3.根据权利要求2所述的植入物，其中，至少一个支承部件与所述基部配合并被联接至所述压力施加部件。
4.根据权利要求3所述的植入物，其中，所述压力施加部件具有至少一个通道，所述固定元件的所述远端伸展穿过所述通道以接合所述第二椎骨体的所述一端。
5.根据权利要求3所述的植入物，其中，所述支承部件适合进行伸展。
6.根据权利要求5所述的植入物，其中，所述支承部件适合通过流体进行伸展。
7.根据权利要求6所述的植入物，其中，所述流体是液压流体。
8.根据权利要求5所述的植入物，其中，所述可伸展的固定元件可相对于所述支承部件进行伸展。
9.根据权利要求5所述的植入物，其中，所述可伸展的固定元件可独立于所述支承部件进行伸展。
10.根据权利要求1所述的植入物，其中，所述可伸展的固定元件适合通过流体进行伸展。
11.根据权利要求10所述的植入物，其中，所述流体是液压流体。
12.根据权利要求10所述的植入物，其中，所述液压流体包括可固化的聚合物，所述聚合物具有用于提供机械力的液压传递的流体状态以使所述固定元件伸展而接合相邻椎骨体。
13.根据权利要求9所述的植入物，其中，所述聚合物被固化成固态以锁定被伸展了的固定元件，从而将所述脊柱植入物保持在椎骨体之间的空间内。
14.根据权利要求13所述的植入物，其中，所述聚合物包括甲基丙烯酸甲酯。
15.根据权利要求8所述的植入物，其中，所述可伸展的固定元件以可滑动方式布置在可伸展的部件的孔内。
16.根据权利要求15所述植入物，其中，所述可伸展的固定元件通过液压流体在所述可伸展的部件的所述孔内进行伸展。
17.根据权利要求5所述的植入物，其包括与所述基部配合的多个可伸展的支承部件。
18.根据权利要求17所述的植入物，其中，所述可伸展的支承部件中的至少两个适合单独地进行伸展。
19.根据权利要求5所述的植入物，其中，多个支承部件与所述基部配合并被联接至所述压力施加部件。
20.根据权利要求19所述的植入物，其中，所述支承部件中的至少两个具有孔并且具有布置在所述孔内的可伸展的固定元件。
21.一种用于治疗病人的椎骨结构的系统，其包括：
a.脊柱植入物，其具有：
i.用于接合第一相邻椎骨体的一端的第一表面，
ii用于接合第二相邻椎骨体的一端的第二表面；
iii.至少一个可伸展的部件，其被构造成使所述第一表面和所述第二表面中的至少一个从缩回构造伸展至与相邻椎骨体的一端接触的伸展构造；以及
iv.至少一个可伸展的固定元件，其具有远端、缩回构造以及伸展构造，所述缩回构造在所述植入物内用以方便所述植入物在所述第一椎骨体与所述第二椎骨体之间展开，所述伸展构造用以使所述远端伸出所述第二表面以刺入所述第二相邻椎骨体的一端内并将所述植入物固定在所述第一相邻椎骨体与所述第二相邻椎骨体之间的空间内；以及
b.用于在所述至少一个可伸展的固定元件处于所述缩回构造的情况下将所述脊柱植入物插入两个椎骨体之间的空间内的装置。
22.根据权利要求21所述的系统，其中，所述植入物的所述第二表面具有通道，并且在伸展为所述伸展构造后所述固定元件伸展穿过所述通道。
23.根据权利要求21所述的系统，其中，所述植入物具有至少一个可伸展的支承部件，所述至少一个可伸展的支承部件被连接在第一压力施加面与第二压力施加面之间以使所述植入物在两个相邻的椎骨体之间的空间内进行扩展。
24.根据权利要求23所述的系统，其中，所述至少一个可伸展的支承部件具有孔，所述孔接纳在所述支承部件伸展后被伸展了的固定元件。
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