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脊椎分离嵌入物

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CN1280473A
CN1280473A CN 98811736 CN98811736A CN1280473A CN 1280473 A CN1280473 A CN 1280473A CN 98811736 CN98811736 CN 98811736 CN 98811736 A CN98811736 A CN 98811736A CN 1280473 A CN1280473 A CN 1280473A
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spine
distraction
implant
spine distraction
distraction implant
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CN 98811736
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CN1167387C (zh )
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詹姆斯·F·朱彻曼
肯·Y·舒
查尔斯·J·温斯洛
亨利·A·克里斯
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圣弗朗西斯医疗技术公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7065Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025Joint distractors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7068Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/366Lactones having six-membered rings, e.g. delta-lactones
    • A61K31/37Coumarins, e.g. psoralen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/60Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66Alignment, compression or distraction mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7064Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7071Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025Joint distractors
    • A61B2017/0256Joint distractors for the spine
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S606/00Surgery
    • Y10S606/907Composed of particular material or coated
    • Y10S606/91Polymer

Abstract

一种脊椎分离嵌入物(1000),该嵌入物用扩大椎管和/或神经孔容积的方法来缓解与脊椎狭窄、小平面关节病变有关的疼痛。该嵌入物具有一个脊椎牵引阻止件(1016),同时允许脊椎自由弯曲。

Description

脊椎分离嵌入物

相关专利申请:本申请是1997.10.27提出申请的题为“脊椎分离嵌入物”的美国专利申请序列号08/958,281的后续中请。而该专利申请08/958,281是1997.1.2提出申请的题为“脊椎分离嵌入物和方法”的美国专利申请序列号08/778,093的后续申请。

发明背景:在社会呈现老龄化时可以预见有害的脊椎疾病将会增加,这种病是老年人的特征。作为例子,随着老化而来的将是脊椎狭窄(包括但不限于中心管狭窄及侧向孔狭窄)、组成椎柱的骨的肥厚以及小平面关节病变的增加。脊椎狭窄的特征是血管及神经通道的有效空间减小。与脊椎狭窄有关的疼痛可以通过药物治疗和/或外科方法来减轻。当然,所有的人特别是中老年人都会要求不进行较大的外科手术。

因此,有需要开发一种对人体损伤最小、能被中老年人接受并可在门诊条件下实施的方法及嵌入物来缓解这种病痛。

发明综述:本发明的目标为提供一种对人体损伤最小的嵌入物及方法来缓解与椎柱相关的病症。

本发明所提供的装置及方法是通过对加在上述的血管及神经上的压力和束缚进行释放来缓解疼痛。本发明通过使用一种嵌入物及方法来完成这种压力释放。为了缓解脊椎狭窄及小平面关节病变之类所造成的问题,这种嵌入物及方法将相邻椎骨的棘突分离。虽然这种嵌入物及方法是特别针对中老年人的需要,但此发明对于所有年龄和身材的人,只要对棘突分离有利都可以使用。

本发明的一个方面是提供一种缓解疼痛的嵌入物。该嵌入物包括一个位于第一棘突及第二棘突之间的器件。该器件包括一个椎柱牵伸阻止件以及一个椎柱弯曲脱束器(non-inhibitor)。

本发明的另一方面为嵌入物位于第一棘突及第二棘突之间并包括一个分离楔。当该嵌入物位于棘突之间时该分离楔能分离第一及第二棘突。

本发明的又一方面为嵌入物包括一个器件。该器件适于在位于相邻两个棘突之间时增加椎管和/或神经孔的容积。

本发明的又一方面为一种方法。该方法的目的为缓解由于,例如但不限于,脊椎狭窄和小平面关节病变的形成所引起的疼痛。该方法由两个步骤组成:接近椎柱的第一及第二棘突,以及将棘突分离足够的距离来增加椎管的容积以缓解疼痛。该方法还包括嵌入一个器件来维持所需的棘突分离量,该分离量是缓解这种疼痛所要求的。

本发明的又一方面为该方法包括嵌入一个器件来得到所要求的分离量并维持此分离量。

本发明的又一方面为该嵌入物包括一个第一部分及一个第二部分。为了达到所要求的分离量就要一起推动这两个部分。

本发明的又一方面为该嵌入物包括一个分离装置及一个保持装置。分离装置包括一个本体,本体可以在相邻的棘突之间推动。本体包括一个槽。在分离装置到位以后,上述保持装置便配装进入此槽并固定在这里。

本发明的又一方面为该嵌入物包括一个带有中心体的第一装置。中心体上套有一个套筒,套筒及中心体的至少一部分之间留有间隔,以允许套筒向中心体方向挠曲。

本发明的又一方面为该嵌入物包括一个带有中心体的第一装置。中心体带有一个导引头及一个第一翼,第一翼位于中心体的第一端上。导引头从中心体的第二端上伸展,第二端位于相对于第一翼的最远端上。嵌入物还包括一个套在所述中心体上的套筒。套筒及中心体的至少一部分之间留有间隔,以允许套筒向中心体方向挠曲。嵌入物还包括一个第二翼及一个将第二翼固定在第一装置上的器件。其中该套筒位于第一及第二翼之间。

本发明的又一方面为一个包括一个可向内挠曲的柱形套筒的嵌入物系统。该系统还包括一个插入工具,插入工具包括一个插入导引头、一个中心体、一个阻止件及一个手柄。导引头及阻止件从中心体相对的两侧伸展,手柄从阻止件上伸展。套筒与导引头相配并支靠在阻止件上,以准备与插入工具一起放置在相邻椎骨之间的位置上。

本发明的又一方面为一个包括有中心体及第一和第二翼的嵌入物。该嵌入物还包括一个装置,其用途为有选择地确定第一、第二翼中的一个翼对另一个翼的相对位置,以适应不同尺寸的棘突。

在本发明精神及范围内还有其它嵌入物及方法可以用来增加椎管的容积,因而缓解对血管和神经的束缚及随之而产生的疼痛。

附图简要说明:图1及2所示为本发明嵌入物的一个实施例,该嵌入物是可调整的以选择所需的分离量,图1所表示的嵌入物比图2所示的处于更伸展的状态;图3a及3b所示为图1所示的实施例的第一分叉端头的侧视及端视图;图4a及4b所示为图1所示的嵌入物的一个中介构件的侧向截面图及端向视图;图5a及5b所示为图1所示的实施例的第二分叉端头的侧视及端视图;图6、7、8、9、及10所示为本发明的另一个实施例用于在相邻两个棘突之间形成分离的装置及方法;图11、12及13所示为本发明的又一个在相邻两个棘突之间形成分离的实施例;图14及15所示为本发明的又一个实施例用于形成分离的装置及方法;图16、16a及17所示为本发明的又一个实施例;图18、19、及20所示为本发明的又一个实施例的装置及方法;图21及22所示为本发明的又一个实施例;图23、24及25所示为本发明的另一个实施例;图26、27及28所示为本发明的另一个实施例;图29及30所示为本发明实施例的不同构形嵌入物的侧向正视图;图31、32及33所示为本发明的一个装置的不同嵌入位置;图34及35所示为本发明的又一个装置及方法;图36、37及38所示为本发明的三个不同的实施例;图39及40所示为本发明的又一个实施例的装置及方法;图41、42及43所示为本发明的一个装置及方法的又一个实施例;图44所示为本发明的一个嵌入物的又一个实施例;图45所示为对本发明的一个装置及方法的另一种描绘;图46及47所示为本发明的一个实施例的又一个装置及方法;图48、49、50及51所示为本发明的又一个装置及方法;

图52、53、54、55a、及55b所示为本发明的另一个装置及方法;图56、57及58所示为本发明的又一个装置及方法;图59及60所示为本发明的又一个实施例;图61所示为本发明的另一个实施例;图62及63所示为本发明的又一个实施例;图64及65所示为本发明的又一个实施例;图66所示为本发明的另一个实施例;图67及68所示为本发明的又一个实施例;图69、70、71及71a所示为本发明的又一个实施例;图72及73所示为本发明的又一个实施例;图74、75、76、77及78所示为本发明的又一个实施例;图79、80、80a、81、82、83、83a、84、85、86及87所示为本发明的又一个实施例;图88、89、90及91所示为本发明的又一个实施例;图92、92a、92b、93、93a、93b、93c、93d、94、94a、94b、95、95a及96所示为本发明的又一个实施例,该实施例包括一个套筒,当棘突之间发生相对运动时该套筒能作出挠曲响应;图97所示为本发明的又一个实施例;图98所示为本发明的又一个实施例;图99及100所示为本发明的又一个实施例,该实施例包括一个插入工具;图101、102、102a、103、104、105、106及107所示为本发明的又一个实施例;图108、109及110所示为本发明的又一个实施例;图111、112、113、114、115、116及117所示为本发明的又一个实施例。

图118所示为可用在本发明几个实施例中的优选材料特性的线图。

优选实施例详细说明图1-5a、5b所示的实施例在图1至5a、5b中表示了本发明的一个实施例。嵌入物20包括有第一及第二分叉端头22及24,每个端头相应地确定了一个凹谷26、28。分叉端头22及24用一个中介构件30相配。如图3a、3b所示,第一分叉端头22包括一个从凹谷26向后伸展的螺纹轴32。该螺纹轴32配装入中介构件30的螺纹孔34(图4a)内。

第二分叉端头24(图5a、5b)包括有一个光滑圆柱轴36,该圆柱轴可配装入中介构件30的光孔38。

图1所示为嵌入物20处于完全伸出状态,而图2所示为嵌入物处于未伸出状态。从其未伸出状态中可以看到第一分叉端头22的螺纹轴32与第二分叉端头24的空心圆柱轴36的内孔相配。

为了嵌入到椎柱的相邻第一、第二棘突之间的位置上,嵌入物20配置成如图2所示。首先用合适的外科技术将第一及第二棘突暴露出来,然后将嵌入物20处于这样的状态下,使得凹谷26与第一棘突相接合而第二凹谷28与第二棘突相接合。为此,可用合适的工具或销子插入十字分布的孔40内并转动而使中介构件30转动,使凹谷26产生相对于凹谷28的位移。这样的转动使得两个棘突之间的间隔扩大或产生分离,其结果及利于增加椎管容积,从而缓解了对血管及神经的任何束缚。

应该指出,该嵌入物以及这里所述的其它不同的嵌入物都起了牵伸阻止件的作用。这就意味着当背部向后弯曲时,处于牵伸状态下的相邻棘突之间的间隔不可能减少到小于凹谷26及28的最低点之间的距离。然而,当脊柱向前弯曲时,该嵌入物不对脊柱的挠曲产生约束或以任何方式进行限制。

这样的器件所提供的分离量的最佳范围为约5毫米到约15毫米。然而,根据各个病人的特征,可以使用分离到22毫米以上的嵌入物。

为了获得上述牵伸阻止件和脱束器的好处,嵌入物20可以基本上浮动地嵌在应有位置上,并保持所有与棘突有关的韧带(诸如棘上韧带)和组织完整无损。如果需要,两个凹谷26中的一个可以用销子29与两个棘突中的一个侧向销牵在一起,而另一个凹谷可以用系绳31与另一个棘突松散地相联。为了保持凹谷对于棘突的相对位置,系绳31或是穿过棘突或是绕在棘突上然后系缚在凹谷上。为了使凹谷可以相对于棘突作位移,也可选择为将两个凹谷用系绳松散地系缚在相邻的棘突上。

凹谷的形状为一个凹面,其优点为可以分散凹谷与相应棘突之间的作用力。这样可以保证不致因为安放嵌入物20而发生骨的消溶并能保持骨的结构完整性。

该实施例中的嵌入物20可以用许多种材料制成,包括但不限于不锈钢、钛、陶瓷、塑料、弹性体、复合材料或以上材料的任何组合。另外,嵌入物的弹性模量可与骨的模量相匹配,所以嵌入物20不是太坚硬。为了增强嵌入物的柔顺性,还可以在整个嵌入物上除了孔40以外再加一些小孔或孔洞。这些孔同时也具有上面所说的目的,也就是使中介构件30转动以扩大凹谷26、28之间的距离。

应该了解,在本实施例中首先要用合适的工具来接近并分离棘突,再将嵌入物20插入并对其进行调整以达到并保持所需的分离量。另外,接近棘突并将嵌入物20放到合适的位置上。一旦就位,即对嵌入物的长度进行调整以分离棘突或对已分离棘突的分离量进行扩大。因此说,嵌入物可以用来产生分离量或用来保持已有的分离量。

嵌入物的位置,诸如嵌入物20对棘突的相对位置将在下面的其它实施例中讨论。然而可以指出,理想的是将嵌入物20放在靠近脊柱的瞬时转动轴的地方。这样做可使嵌入物20受力最小而且嵌入物20作用在脊柱上的力最小。

还要指出,在嵌入物20的安装或嵌入的实际过程中,本发明的方法采取这样的途径:首先将嵌入物20的长度增加一个第一增量,然后让脊椎进行蠕变或适应此分离增量。之后再将嵌入物20的长度增加另一个增量,随后的一段时间内让脊椎进行蠕变或适应新的分离水平。此过程可反复进行直至达到所要求的分离量。相同的方法可以用在嵌入物装入之前所使用的插入工具中。在嵌入物装入之前,工具可以通过一系列的脊椎分离增量及脊椎蠕变时间来达到所要求的分离量。

图6、7、8、9和10所示实施例图6、7、8、9和10所示实施例包括具有第一及第二臂52、54的分离或扩展工具50。臂52、54可以绕着支点56转动并可从支点56处分开,以实现嵌入物58的嵌入。如从图6所见,臂52、54的截面形状稍微有些内凹,其目的为将第一、第二棘突60、62相应地架撑并固定在臂52、54上。可以通过病人背部的小切口插入分离工具50以瞄准第一棘突60第二棘突62之间的间隔处。当工具50恰当的就位后,便可将臂52、54分开以分离棘突。在这以后,便可将一个如图8及9所示的嵌入物58或如本发明其它实施例中所示结构的嵌入物,通过臂52、54之间推入到两个棘突之间的位置上。此后,便可将臂52、54从棘突间拖出而嵌入物58则留在应有的位置上。嵌入物58是用工具64推入到位的。工具64通过嵌入物背面的螺孔66而固定在嵌入物58上。如从图10所见,嵌入物58包括有两个凹谷68及70,该凹谷以与上述第一个实施例及工具50的单独的双臂十分相同的方式,将上、下两个棘突60、62架撑起来。如上所述,凹谷有助于分散棘突及嵌入物之间存在的载荷,并可保证棘突稳定地安放在相应凹谷的最低点上。

图11、12及13所示的实施例图11、12及13所示为本发明装置及方法的另一个实施例。在这个实施例中,扩展或分离工具80包括有以支点86为永久性枢轴的第一及第二臂82、84。两个臂包括有L形的端头88、90。此L形端头88、90可通过一个小切口插入到第一及第二棘突92、94之间。就位之后便可张开双臂82、84以分离两个棘突。然后可将嵌入物96推到两个棘突之间以保持其分离量。这里指出,嵌入物96包括有楔形表面或两个斜面98、100。当嵌入物96推入两个棘突间时,斜面更进一步的使两个棘突分开。嵌入物96完全嵌入后便由位于斜面后面的平面99、101来维持其全分离量。不言而喻,嵌入物96的截面形状可与上述嵌入物58或其它嵌入物相似,以获得分布载荷及稳定性方面的优点。

图14、15、16、16a及17所示实施例图14及15所示为又一个本发明的实施例。其中嵌入物110包括第一及第二两个圆锥形元件112、114。元件112包括有一个外卡扣接头116,而元件114包括有一个内卡扣接头118。当将外卡扣接头116推入内卡扣接头118内时,第一元件112便锁定在第二元件114的位置上。在该实施例中,可能要用到分离或扩展工具80。当棘突已被撑开之后,可用工具120来将嵌入物110咬合在一起并安放到位。嵌入物110的第一元件112被装在工具120的一个臂上,而第二元件114则装在另一个臂上。元件112、114安放在相邻棘突之间空间的相对立的两侧上。元件112、114是同时被推动的,因此嵌入物110便如图15所示被锁定在两个棘突之间的应有位置上。这里指出,也可以用下述方法来将嵌入物110制造得更具有自动分离的特征,以使嵌入物110能保持其对两个棘突的相对位置,并也产生一些附加的分离量。这个方法就是将圆柱表面122也制成象圆锥表面124那样具有更大的锥度。

图16、17所示为嵌入物的一个替换实施例。该嵌入物130包括有第一及第二元件132、134。在这个具体的实施例中,嵌入物用一个螺钉夹在一起(图中未表示)。该螺钉穿过锥口孔136插入并与第二元件134的螺纹孔138相接合。表面139是平面(见图17),以便承载和分散来自两个棘突的施加在表面上的载荷。

嵌入物130的这个实施例,就象图14、15所示的实施例110那样,其整体外貌不是圆形的。就图16、17所示嵌入物130的这个具体的实施例来说,该实施例的两侧边140、142切成平面,而上、下两边144、146则向外延伸以形成凹谷来接纳上下两个棘突。上下两个边144、146是倒圆的,以使嵌入物与两个棘突从解剖学上更相协调。

如有需要,并为了保证第一及第二元件132、134互相对准,可以设置以特殊的方式互相配合的键148和键槽150。键148包括至少一个平面,诸如平面152。该平面与键槽150上的相应的平面154相配合。这样,第一及第二元件便能恰当的互相配合而形成适宜的上、下凹谷。该凹谷可将嵌入物130相对上、下两个棘突固定。

图16a所示为第二元件134与一个圆形前导入塞135相配合的情况。导入塞135包括一个能和键148很好地吻合的孔137。在该结构中,导入塞135的作用为帮助将第二元件134放到两个棘突之间。一旦第二元件134恰当的就位之后便可将导入塞135摘除。不言而喻,为了帮助推开两个棘突和软组织以使第二元件134到位,导入塞135可以具有其它形状,诸如棱锥形、圆锥形。

图18、19及20所示实施例图18所示嵌入物330包括互配的第一及第二楔子332、334。为了嵌入这一对楔子332、334,要从两边来接近棘突然后用工具从互相朝向的方向来推动两个楔子。当从互相朝向的方向来推动两个楔子时,这两个楔子便互相相对进移,于是位于上、下两个棘突336、338(见图20)之间的嵌入物330的总尺寸便会增加,因而便将两个棘突分离。这里指出,楔子332、334包括有容纳棘突336、338的两个凹谷340、342。这两个凹谷具有如前面叙述过的优点。

第一及第二楔子332、334具有一种起配合作用的构造,这种构造包括一个沟槽344及一个突榫346。为了将楔子332、334锁定在一起,可将突榫346推入沟槽344内。沟槽344是凹形的以使突榫不致与它分离。另外,如同这里所述的其它器件一样,在沟槽与突榫二者中的任一个上可设置一个制动销,而在另一个上则设有凹口。一旦二者咬合在一起,两个楔子就不会沿着沟槽344相对滑动。

虽然以上实施例的叙述是就楔子而言的,但也可以将楔子设计成基本上为一圆锥,其性能及优点仍将相同。

图21及22所示实施例嵌入物370包括第一及第二分离锥372、374。两个锥都用柔性材料制造。如图21所示,棘突376、378的两侧都安放有分离锥。可用前面已叙述过的适用工具将分离锥372、374推合在一起。推合以后,该分离锥便如图22所示将两个棘突分离。此后便可用一个合适的螺钉或其它机械固定器件380来保持分离锥372、374的这个状态。这种构造的优点为嵌入物370具有自动分离的特性,以及嵌入物是柔性的并如图22所示那样成形在两个棘突附近。

图23、24及25所示实施例图23及24所示为嵌入物170的另一个实施例。该嵌入物用一个L形的导引工具172引导到位。为了架撑并导引嵌入物170到位,导引工具172的截面形状就象图6中的分离工具50一样是内凹的。最好是在病人的背部做一个小切口,并将L形导引工具172插入到相邻两个棘突之间。嵌入物170可装在插入工具174端头上并推入到棘突之间的位置上。如果需要,可以通过将嵌入物推入到位的动作使棘突进一步的分离。在L形导引工具172插入之前,可先用如图13所示的分离工具来分离两个棘突。

嵌入物170可以用可变形材料来制造,因此能将它推入到位并在某种程度上与上、下棘突的形状相一致。这种可变形材料最好是一种弹性材料。这种材料的好处是嵌入物与棘突之间的作用力被分散在很大的表面积上。另外,嵌入物将自动成形为不规则的棘突的形状,从而将嵌入物相对棘突定位。

从图25来看,嵌入物176可以套在一个导引线或导引工具或通管丝178上。首先将导引线178通过病人背部的小切口插到相邻两个棘突之间的位置上。然后将嵌入物穿套在导引线178上并推入到两个棘突之间的位置上。如果需要进一步的分离棘突,此推入动作可以进一步分离。一旦嵌入物安置到位,便可取走导引工具178并封闭切口。如果需要,也可使用图23及24所示的插入工具。

图26、27及28所示实施例图26、27及28所示的实施例使用的嵌入物与图8和图9所示的相似,但插入工具不同。如从图26所见,使用一种与图12所示的L形分离工具相似的L形分离工具190来分离第一及第二棘突192、194。分离之后,将一个插入工具196放到两个棘突192、194之间。插入工具包括一个手柄198,手柄上装有一个方形环200。

可以通过病人背部的一个小切口插入分离工具190来撑开两个棘突。然后将这个小切口向侧向稍稍扩大后将方形环200的上端202先插入切口内,随后将方形环200的剩余部分插入。方形环插入以后,可以向下移动手柄198来使方形环稍稍转动以更楔入棘突使其更加分开。这些动作完成后,可以穿过方形环插入一个诸如嵌入物204那样的嵌入物并通过嵌入物手柄206使该嵌入物恰当就位。此后,便可取出手柄206及插入工具196。

图29、30、31、32及33所示实施例如从图29及30所见,从侧面看起来嵌入物210、212可以有不同的形状。这些嵌入物与前面提到过的嵌入物58(图8)及嵌入物204(图28)相似。这些嵌入物的截面形状与图10所示嵌入物相似,而包括有凹谷以容纳并固定住相邻两个棘突。

如从图31、32及33所见,嵌入物可以相对棘突214放在不同位置处。最好是如图33所示将嵌入物210放在靠近椎弓板216处。在这个位置上,嵌入物210更靠近脊柱的瞬时转动轴218,脊椎运动时嵌入物所经受的力最小。因此从理论上说,这是嵌入物的最佳嵌入位置。

如从图31及32所见,嵌入物可布置在棘突的中部(图32)以及棘突的朝后一边(图31)。如果嵌入物210放在如图31所示的位置上,由脊柱伸缩的组合而作用在嵌入物上的力最大。

图34及35所示实施例图34及35所示为本发明的另一个实施例。图中的嵌入物220由许多单独的基本上为V形的薄片222组成。薄片上包括有连接用的凹坑或制动销224。亦即,每个薄片包括一个凹坑同时包括一个相应的凸起。这样,一个薄片上的凸起与相邻薄片上的凹坑相配。该实施例还包括一个具有与单个薄片形状相一致的钝头端228的插入工具226。为了将嵌入物嵌入如图29所示棘突之间的空间内,首先用插入工具226将单个薄片220插入。然后用工具插入第二个薄片,第二个薄片上的凸起224咬入由于制作第一个薄片的凸起224而形成的相应凹坑。然后重复地将第三及随后各个薄片插入直至在两个棘突之间形成合适的间隔。如由图29所见,单个薄片222的侧缘229稍微向上弯曲而呈马鞍形以容纳上、下棘突。

图36、37及38所示实施例图36、37及38所示实施例包括各嵌入物230、232及234。这些嵌入物设计成一旦正确就位在两个棘突之间,即自动锁定在这个位置上。嵌入物230基本上是由一系列的截头锥体组成并包括许多不断扩大的台阶236。这些台阶是由这些圆锥体形成的,这些圆锥体起始包括尖头体238及跟在它后面的圆锥体240。嵌入物230看上去大体上象一棵横躺在地的枞树。

嵌入物230是通过位于上、下棘突之间的开口横着插入的。第一锥体238产生初始分离量。以后的锥体逐个地分离棘突形成更大的分离量。当达到要求分离量时便利用台阶236将棘突锁定在这个位置上。如果需要,可将嵌入物的尖头体238及其它锥体段240弄碎、折断或锯掉,以减小嵌入物230的尺寸。由于嵌入物的一部分是要弄碎或折去的,诸如锥体238与240之间的界线242处要适当的去掉一些材料以削弱它们。但要指出,仅是开头两段锥体的界线需要削弱。而仍需留在棘突之间的锥体间的界线244由于并不打算在这里将嵌入物弄断,因此不需削弱。

图37表示嵌入物233位于上、下两个棘突之间的情况。嵌入物的截面形状为楔形或三角形的,并包括有孔群245、246。通过这些孔可以插入销子248、250。该三角形或楔形嵌入物可以横向的推入上、下两个棘突之间并将其分开。一旦达到要求的分离量,便可将销子248、250插入孔群245、246中的合适的孔中以将棘突锁在由销子248、250及斜面233、235形成的V形凹谷中。

现在来看图38,图中的嵌入物234具有与图32相似的三角形或楔形的本体。在该实施例中,三角形本体234上装有可绕着枢轴转动的调整片252、254。当嵌入物234分离两个棘突达到要求的分离量而合适地就位后,调整片252、254旋转到位使嵌入物234保持在此合适位置上。

图39及40所示实施例在图39、40所示实施例中,环管258通过一个小切口插入到上、下两个棘突之间。环管合适地插入之后,用一个插入工具262推动嵌入物260通过环管258。嵌入物260包括有许多肋或缺口264,其作用为帮助嵌入物260相对上、下两个棘突上就位。嵌入物260进入应有位置以后便将环管258抽走,此时嵌入物260便与两个棘突接触并楔在二者之间。环管258稍稍带有锥度,尖头端266稍小于远端268以利于将环管插入到两个棘突之间的空间内。

另外,可以改用许多根环管而不是仅使用一根环管,每根环管都较前一根环管稍大一些。在本发明的这一方法中,第一根较小的环管插入以后,便逐次地将较大的环管套在前面一根环管的外面。然后将较小环管从大环管中间抽出。直到最大的一根环管到位皮肤上的开口也相应扩大时,仅能由较大环管才可容纳的嵌入物便可通过大环管而进入到位。

图41、42及43所示实施例图41、42中预先弄弯的嵌入物270及图43中预先弄弯的嵌入物272二者的导入技术相同。该导入技术包括一根引导线,引导工具,或通管丝274。这两个实施例的引导线274都是穿过病人的皮肤恰当地就位在两个棘突之间的空间内。引导线就位之后,嵌入物在引导线上被导引进入两个棘突之间的位置上。具有预弯特征的嵌入物可以从两侧进入棘突之间,即(1)通过病人皮肤的第一小切口将嵌入物从棘突的一侧安放在两个棘突之间的空间内,以及(2)导引嵌入物通过病人皮肤的第二小切口到达两个棘突之间空间的另一侧。嵌入物270包括一个圆锥形的导引尖头锥276及一个远端部分278。当尖头锥276插到两个棘突之间时便将两个棘突分离。在嵌入物270的相对的两端制有断裂线280、282。嵌入物在两个棘突之间的导引线上正确就位后便可沿着断裂线将尖头锥276及远端278截断,并通过上述两个小切口取出,而嵌入物270则留在应有位置上。

虽然图中仅表示出两个断裂线280、282,但嵌入物270上可以有多个断裂线,因此嵌入物可以沿着导引线278连续地送进,直至适宜的嵌入物270的宽度导致产生要求的分离量时为止。如前面所述,断裂线可以通过钻孔或其它削弱嵌入物270的方法来形成,因此嵌入物的适宜部分可以折断或锯去。

预弯的嵌入物272与图36所示的嵌入物230具有相似的结构。但图43中的嵌入物272是预先弄弯的并且是套在一个导引线274上进入到两个棘突之间的位置上的。如同图43所示嵌入物230一样,一旦达到了所要求的分离量并且如果需要,可以如上面所述将部分嵌入物272截断、折断或锯去,留下嵌入物的一部分楔在上、下两个棘突之间。

图44所示实施例图44所示为本发明的又一个实施例。该实施例包括一个插入工具及嵌入物的组合物290。此插入工具及嵌入物290呈圆环形,该圆环铰接于点292上。这个圆环由细长的并呈圆锥形的第一元件294及第二元件296形成。第一及第二元件294、296终止于点292上并通过铰链292而互相对准并相交。第一及第二元件通过棘突两侧病人皮肤的相似切口插入并在两个棘突之间交会在一起。在这之后,转动,例如顺时针方向转动嵌入物290使得第一元件294的较宽部分将第一及第二棘突分离。当达到所需的分离量时,便可按前面所述方法,将圆环的位于两个棘突之间前、后一段的其余部分截去来保持所要求的分离量。也可以选用充分小的圆环,那么整个圆环便可留在已分离的棘突之间的位置上。

图45所示实施例在图45中,嵌入物300包括许多插入上、下棘突之间的细杆或通管丝302。这些细杆设计成如前面所述那样可以截断、折断或切去的。一旦这些通管丝插入并达到合适的分离量,便可将通管丝折断,并且每个通管丝的一段存留来保持两个棘突的分离量。

图46及47所示的实施例图46、47所示的嵌入物310包括有形状记忆材料,这种材料在被释放时会卷绕。这种材料在递送工具312中处于打开状态。递送工具进入到上、下两个棘突314、316之间的位置上。然后经由递送工具将材料推进去。当该材料从递送工具的递送端318上释放出时便卷绕而将两个棘突分离到要求的分离量。一旦达到分离量便可将材料切断并取出递送工具。

图48、49、50及51所示实施例如从图48所见,用递送工具326将嵌入物320递送到上、下两个棘突322,324之间。一旦嵌入物320进入两个棘突之间的应有位置时,便将递送工具旋转90°以迫使嵌入物从图49所示取向转变为图50所示取向,即由最大尺寸与两个棘突基本垂直转变为其最大尺寸与两个棘突平行并在一条直线上。这一旋转使得两个棘突之间产生所要求的分离量。嵌入物320的两端包括有对置的两个凹槽325及323。嵌入物320的旋转使两个棘突卡入这两个凹槽内。

一种可选择的方案是,可用插入工具326将多个嵌入物320、321插到两个棘突322、324(图51)之间的空间内。可以插入多个嵌入物320、321直到建立起合适的分离量。不言而喻,在这种情况下可以用下述方法将一个嵌入物锁定在另一个嵌入物上:例如,在嵌入物上设有沟槽及凸起物,一个嵌入物上的凸起物可以被接纳进入另一个嵌入物上的沟槽中并锁定在那里。这种沟槽的构造将在其它实施例中描述。

图52、53、54、55a及55b所示实施例图52至55b所示实施例包括一个充满流体的动力分离嵌入物350。该嵌入物包括一个套在预弯的插入杆354上并通过棘突356一侧的切口插入的薄膜352。将弯曲的插入杆354连同套在上面的嵌入物350导入到两个棘突之间。完成之后即可取出插入杆354而将柔韧的嵌入物留在应有位置上。然后将嵌入物350与一个流体源(气体、液体、凝胶等等)相连并迫使流体进入嵌入物使其如图54那样的扩张起来,并将两个棘突分离到要求的分离量。一旦达到所要求的分离量后便将嵌入物如图55a那样封口。嵌入物350是柔韧的,可能是不规则形状的棘突模制成形,因而能保证定位。另外嵌入物350还起减振作用,能衰减嵌入物与棘突之间产生的力及应力。

可以用许多种材料来制造嵌入物及充入嵌入物中的流体。例如,诸如甲基纤维素或透明质酸等粘弹物质可以用来充填嵌入物。另外可以充入开始时是流体但以后再行固化的材料来形成必须的分离量。材料固化以后,便在棘突附近成形为常用的形状,从而至少相对两个相邻两个棘突中的一个来说是保持在应有位置上。因此可以看到,使用这个实施例及合适的插入工具,嵌入物可以以图55b方式驻留并成形在一个棘突附近。使用这个实施例,可以将单独一个嵌入物用作位于任何一侧的棘突的牵伸阻止件而不束缚脊柱的弯曲。

不言而喻,这里所公开的许多其它嵌入物都可以修改成象嵌入物350那样可以接纳流体来建立并保持所需的分离量。

图56、57及58所示实施例图56所示嵌入物360包括一种诸如一种塑料或一种金属的形状记忆材料。一个弯曲的引导工具362如前面所述的那样放在适宜的两个棘突之间。放好之后,将嵌入物的孔364套到工具上。这个动作使得嵌入物处于打开状态。然后将嵌入物推入到位并将两个棘突分离。在这之后,便可取出插入工具362而让嵌入物呈现其预打开的形状并固定在两个棘突中的一个附近。这种构造使得嵌入物既作为牵伸阻止物而又不妨害脊柱的弯曲。另外,嵌入物可以是温度敏感的。这就是说,嵌入物在开始时更易打开,而当其被病人的体温所温暖时就会变得更为弯曲。

图59及60所示实施例在这个实施例中,嵌入物380包括许多互锁的薄片382。开始时,将第一个薄片放到相对的两个棘突384、386之间。然后相继放入多个薄片382直到这两个棘突之间建立起要求的分离量。这些薄片有些类似弹簧,以吸收冲击并在某种程度上与棘突相吻合。

图61所示实施例图61的嵌入物390包括在相邻两个棘突396、398上布署屏蔽物392、394。该屏蔽物是用来保护两个棘突不被损坏的。这些屏蔽物包括有小孔来接纳自攻螺钉400、402。在实践中,先将屏蔽物放到两个棘突上并将两个棘突分离到适宜的分离量。完成以后,用两个螺钉通过屏蔽物上的小孔如图61所示的那样将杆404固定在两个棘突上从而保持棘突的分离位置。

图62及63所示实施例图62及63中的嵌入物410包括第一及第二元件412、414。这两个元件可用一个合适的螺钉及螺孔构造接合在一起而形成嵌入物410。主要元件412及相配元件414形成嵌入物410。据此,嵌入物410备有多个元件414可用来和一个标准的第一元件412一起使用。图62及63所示为相配元件414的两种不同形式。图62中的相配元件414包括两个起调整垫片作用的凸起416、418。这两个凸起用来伸入到第一元件412的两个凹谷420、422内。两个凸起416、418可以有不同高度以适应不同尺寸的棘突。槽424位于两个凸起416、418之间,这个槽与第一元件412上的牵伸阻止件426相配。

在图63中,图62所示实施例的两个凸起被两个凹槽428、430所代替。这两个凹槽扩展了凹谷420、422的面积以容纳较大尺寸的棘突。

图64、65及66所示实施例图64、65及66所示的实施例的构造及构思与图62、63的实施例相似。在图64中,嵌入物500包括第一及第二元件502、504。这两个元件可以用合适的螺钉或如其它实施例中的紧固装置固定在一起。嵌入物500包括由第一及第二元件502、504的端头形成的第一及第二凹谷506、508。这两个凹谷506、508是用来容纳并架撑相邻的两个棘突的。由图64可见,每个凹谷506、508都是仅由相应地从第一及第二元件延伸出的单个凸起或单个腿510、512所确定。与图62及63所示的实施例不同的是这里的每个凹谷是仅由一个腿所确定的,因此可以利用与两个棘突相关的韧带及其它组织来保证将嵌入物保持在合适位置上。对于图64那样的构造,由于每个凹谷是仅由单独一个腿所确定的,第一及第二元件可以更容易地在各种组织间的位置中工作,因此比较容易将嵌入物放到相对于两个棘突的合适位置上。

在图65所示实施例中,嵌入物520包括单独一个零件,该零件具有两个凹谷522、524。凹谷522及524由相应的支脚526、528单独确定。为了将嵌入物520放到两个棘突之间的位置上,要在相邻两个棘突侧边之间的位置上造一个切口。先将一个单支脚526通过切口到达与其中一个棘突的相对侧边相紧贴的地方,并将这个棘突架撑在凹谷522上。然后将棘突推开,直至凹谷524可以转到与另一个棘突交会的位置上以保持相邻两个棘突之间的分离量。

图66所示的实施例与图65所示相似。该实施例具有嵌入物530及第一及第二凹谷532、534。凹谷532、534上相应地连有系绳536、538。系绳用商业和工业界公知的材料制成并穿在嵌入物530上的孔中。一旦正确的进入应有位置便将系绳结扎住。应该了解,系绳并不是用来将一个棘突与另一个棘突的相对位置固定下来,而是用来支配两个棘突之间的相对运动,使得嵌入物530可用作牵伸阻止件及弯曲脱束器。换一种说法,凹谷532、534是用来阻挡脊柱向后弯曲及延伸而并不制止向前弯曲及脊柱挠曲。

图67、68所示实施例嵌入物550呈Z形并包括一个中心体552及从中心体上向相反的两个方向伸展的第一及第二臂554、556。嵌入物550的中心体552包括第一及第二凹谷558及560。第一及第二凹谷558、560是用来容纳上、下两个棘突562、568的。因此,臂554、556位于中心体552的远端566附近(见图68)。第一及第二臂554、556的作用为制止嵌入物550向前朝着椎管运动、迁移或滑动并保持嵌入物对第一及第二棘突的相对位置,防止嵌入物压到黄韧带及硬脊膜上。在一个优选实施例中,中心体的高度为约10毫米而每个臂554、556的高度也为约10毫米。根据病人的不同,中心体的高度可能在小于10毫米到大于24毫米之间变化。如由图67、68所见,在第一及第二臂554、556上添加了一些额外的轮廓来容纳上、下两个棘突556、558。具体地说,这两个臂554、556,就臂554而言,具有一个稍微向外弯曲的部分568(图68)及一个稍微向内弯曲的远端570。这个构形使得臂可以与棘突相吻合而其远端570可稍微的推动棘突向嵌入物运动。如果需要,臂554、556可以制造得薄一些和/或钻有孔和/或用其它与中心体552不同的材料制成,以使其较中心体552更柔软。对于最后一个实施例,为了将嵌入物推入相邻两个棘突之间的位置上可先将一个臂插入侧向的切口,然后再将中心体552最后推入到两个棘突之间的位置上。

图69、70、71及71a所示实施例图69、70及71所示为本发明嵌入物580的正面透视图、端向及侧向视图。该嵌入物包括一个具有第一及第二凹谷584、586的中心体582。第一及第二凹谷584、586是用来容纳相邻两个棘突的。嵌入物580还包括第一及第二臂588、590。与前面的实施例一样,臂588、590的用途为防止嵌入物朝着椎管向前迁移或滑动。第一臂588从第一凹谷584向外伸出,而第二臂590从第二凹谷586向外伸出。在一个优选实施例中,第一臂588位于中心体582的远端600附近,仅延伸在中心体582整个长度的一部分上。如图70所示,第一壁588与中心体基本上垂直。另外,第一及第二臂588、590都是按照解剖学要求而倒了圆的。

第二臂590从第二凹谷586伸出,位于远端600稍往后处,并延伸在中心体582整个长度的一部分上。第二臂590从中心体582上伸出并与中心体成一个复合角。如从图70及71所见,第二臂590与凹谷586成约45度角(图70)而与中心体580的长度方向也成约45度角(图71)。不言而喻,如同权利要求中所述,其它的复合角也在本发明的精神及范围之内。

在一个优选实施例中。第一及第二臂588、590的长度约与中心体580的宽度相等。优选的是,每个臂的长度约为10毫米,而中心体的宽度也约为10毫米。然而,中心体的宽度为24毫米和大于24毫米,同时第一及第二臂的长度在约10毫米到大于约24毫米的实施例仍在本发明的精神和范围之内。另外预计,本发明的实施例可包括宽度等于或大于约24毫米、臂的长度约为10毫米的中心体。

应该理解,图69、70及71所示实施例以及图67、68所示实施例的设计最好用来放在脊椎骨对L4-L5及L5-S1的。而图69、70及71所示实施例的特别设计用来放在L5-S1位置上的,其中的臂是设计成与这里可能遇到的斜面相一致的。第一及第二臂的轮廓设计是使它们卧靠在稍具角度的椎板上的。

图69、70及71所示实施例如同图67、68的实施例一样是Z字形的,因此可从相邻两个棘突一侧的切口插入。先是第一臂,继之以中心体都从两个棘突之间的空间中穿过。这种构造仅需在棘突的一侧开切口便可成功地将器件嵌入到两个棘突之间。

图71a的嵌入物610与上一段所述的嵌入物相似,而它的第一臂612与第二臂614却位于嵌入物的同一边。图71a嵌入物的第一及第二凹谷616、618稍加修改成为其远端部分620、622比一般凹谷形更为平坦,其目的为使嵌入物仅从一边即可放到两个棘突之间。一旦就位,与两个棘突相关的韧带和组织将会把嵌入物支撑在应有位置上。如果需要,还可用上系绳。

图72及73所示实施例嵌入物630也设计成为可以仅从相邻两个棘突的一侧插入。嵌入物630包括一个两侧各伸展有第一或第二臂634、636的中心体632。如从图72可见,在中心体632的一端伸展有一个柱塞638。图72所示的柱塞638是完全伸出的而图73所示的为柱塞638是收入到嵌入物630的中心体632内的。当柱塞收入到中心体632内时,第三及第四臂或钩640、642可从中心体632中向外伸出。第三及第四臂或钩640、642可以包括许多种材料,例如形状记忆金属材料或其它具有弹簧特性的材料。

为了将嵌入物630放到相邻两个棘突之间,柱塞630要象图72所示那样拉出。然后将中心体632放到相邻两个棘突之间,此后可使柱塞638移动到如图73所示位置,而第三及第四臂640、642便从中心体632中向外伸出,以将嵌入物630保持在两个棘突之间的位置上。

柱塞638可弹性地偏置在图73所示位置上,或可包括有制动销或其它机械装置将其锁定在这个位置上。另外,第三及第四臂本身当展开时也可将柱塞保持在图73所示位置上。

图74、75、76、77及78所示实施例图74到78所示为本发明的其它实施例。图74、75及76所公开的嵌入物700特别适于嵌入到脊椎骨L4-L5及L5-S1之间。如从图74所见,嵌入物700包括一个中间有一个孔704的中心体702。孔704是用来调整嵌入物的弹性模量到达最佳值。该最佳值大约等于脊椎骨在分离状态下所承受到的解剖学载荷的两倍。换句话说,嵌入物700将比其所承受的正常载荷的两倍更刚硬些。这样的安排是为了使嵌入物具有适当的柔性以减小嵌入物附近骨质消溶的可能性。也可使用其它的模量值,但这仍包含在本发明的精神及范围内。

嵌入物700包括第一及第二凹谷706、708。这两个凹谷706、708用来容纳上、下两个棘突并将来自这两个棘突的载荷分散开来。凹谷706由第一及第二臂710、712确定。第二凹谷708由第三及第四臂714、716确定。如从图74所见,在一个优选实施例中,第一臂710的长度约为本体702长度的两倍,而第二臂712的长度稍小于本体702长度的四分之一。在这个优选实施例中,第三臂714的长度约等于本体702的长度而第四臂716的长度约为本体702长度的一倍半。四个臂的设计思想是(1)嵌入物可以容易而方便地插入到相邻两个棘突之间;(2)不会朝着椎管向前迁移;及(3)在脊柱挠曲、牵伸及横向弯曲时可保持其应有位置。

第一臂710专门设计成适应脊椎骨的形状。如从图74所见,第一臂710沿着离开本体702的方向变窄。第一臂包括一段倾斜部分718,继之以一小段凹进部分720,最后在邻近端头724处以一段倒圆部分722结束。这种设计可以适应如L4椎骨的解剖学形状。应该知道,脊椎骨中有许多表面倾斜大约30°角,而本实施例及图77及78所示实施例的倾斜表面便是设计来适应这种表面的。可以对这些实施例作进一步的修改以适应其它的角度及形状。

第二臂712很小,因而容易插入两个棘突之间,但仍包括有凹谷706。第四臂716比第三臂714大,二者都比第一臂710小。第三及第四臂设计成包括有凹谷708。在脊柱运动时,该凹谷相对嵌入物700导引两个棘突。该凹谷的尺寸设计使得嵌入物容易布位到两个棘突之间。

作为例子,将嵌入物700嵌入体内的程序为先可在两个棘突之间的一侧造一个切口,然后首先将第一臂710插入到两个棘突之间。再用嵌入物和/或合适的工具将两个棘突分离把第三支脚714及中心体702装到两个棘突之间的整个空间内。这时,第三支脚714将座落在下棘突的与切口相对的一侧附近,而两个棘突将支撑在第一及第二凹谷706、708中。较长的第四支脚将有助于使嵌入物700进入应有位置。

图77包括一个与嵌入物700相似的嵌入物740,因而具有相似的编号。嵌入物740的凹谷706、708是倾斜的,以适应如L4-L5及L5-S1脊椎之间的骨结构情况。如同上面已经指出,这个区域中脊椎骨的许多表面的倾斜角在30°上下。因此凹谷706的倾斜角为小于30°,最好为约20°。而凹谷708的倾斜角为约30°,最好为大于30°。

图78所示嵌入物760与图74中的嵌入物700相似,因而具有相似的编号。嵌入物760包括第三及第四支脚714、716。支脚714、716具有向各自的端头766、768倾斜的倾斜部分762、764。该倾斜部分与它们所在之处的下脊椎骨的形状相适应。在优选实施例中,该倾斜角为约30°。然而不言而喻,该倾斜角也包括基本上大于及基本上小于30°,这仍包括在本发明的精神及范围之内。

图79、80、80a、81、82、83、83a、84、85、86及87所示实施例图79到87所示为本发明的又一个实施例。该实施例包括嵌入物800(图86)。嵌入物800包括一个分离单元802。图79、80、及81相应地为分离单元802的左侧视图、正面图及右侧视图。图84为分离单元802的透视图。从图80可以见到分离单元包括一个分离本体804。本体804的纵轴为805。本体804具有一个沟槽806和一个倒圆或球形的端头808。端头808的作用为帮助分离本体进入相邻两个棘突之间的位置而得到一个合适的分离量。在分离本体804上伸展一个第一翼810。在图80中看,第一翼810基本上垂直于分离本体804。但本发明的精神与范围包括与本体不相垂直的翼。第一翼810包括一个上部812及一个下部814。该上部810(图79)包括一个倒圆的端头816及一个小的内凹部818。在优选实施例中,端头816和内凹部818的设计是与L4(对于L4-L5位置)或L5(对于L5-S1位置)椎的上椎板的形状或轮廓相适应的。应当了解,这种形状或这种形状的改型也可适应任何脊椎的任何椎板。在优选实施例中,为了与脊椎相适应,下部814也是倒圆的。该分离单元还包括一个螺孔820。在这个实施例中,螺孔820与一个定位螺钉822相配(图86),以如后面将讨论的那样将第二翼824(见图82、83)固定在应有位置上。

在这个实施例中,螺孔820倾斜约45度角并与槽806相交。当第二翼824到位时,位于螺孔820中的定位螺钉822可以与第二翼824相接触并将其固定在槽806内的位置上。

转而来看图82、83及85即第二翼824的左侧视图、正面图及透视图。第二翼824的构造与第一翼相似。第二翼824包括一个上部826及一个下部828。上部826包括一个倒圆的端头830及一个小的内凹部832。第二翼824还包括一个槽834。槽834与分离单元802上的槽806相配。第二翼824是本实施例的止动单元。

如图83及86所示,第二翼或止动单元824包括具有第一宽度“a”的上部826及具有第二宽度“b”的下部828。在优选实施例中,由于L4-L5或L5-S1椎板形状或轮廓的原因,第二宽度“b”比第一宽度“a”大。在图83a中可以看到,为了适应不同尺寸的棘突及其它解剖学形状或轮廓,第二翼或止动单元824的宽度“a”及“b”都增加了。关于这一点,下面还要叙述。另外如果合适,宽度“a”可以大于宽度“b”。嵌入物可以包括一种具有通用形状的分离单元802,这种分离单元备有多个止动单元824可供选择,每个止动单元的宽度“a”及“b”都不同。当进行外科手术时,可以选择宽度“a”及“b”尺寸合适的止动单元824来与病人的解剖学形状相匹配。

图86所示为一个装配好的嵌入物800位于上、下两个椎骨的上、下椎板836、838(图中以虚线表示)附近。如图86所示,椎骨836、838基本上位于嵌入物800的下方。从椎骨836、838向上伸展出上、下两个棘突840、842。这两个棘突840、842位于第一及第二翼810、824之间。在一个优选实施例中,嵌入物的两翼如图86所示并不与两个棘突接触而仍可适配在两个棘突之间。应该理解,这仍包括在本发明的精神和范围之内。

嵌入物800装配好以后包括一个上凹谷844和一个下凹谷846。上凹谷844具有一个以尺寸“UW”表示的上宽度。下凹谷846具有一个以尺寸“LW”表示的下宽度。在一个优选实施例中,上宽度大于下宽度。在其它实施例中,“UW”可以根据解剖学上的要求而小于“LW”。上、下两个凹谷844、846之间的高度用字母“h”表示。将这些尺寸标到图87中就是一幅两个凹谷之间形成的大体上为梯形的表象简图。下表给出几组如图87所示的上宽度、下宽度及高度数据。此表包括本实施例的几个改型的尺寸数据。表中所有尺寸以毫米表示。

<tables id="table1" num="001"> <table>改型编号123上宽度876下宽度765高度1098</table> </tables>为了通过外科手术将嵌入物800放到病人体内,病人最好采取侧卧体位(图86中箭头841从手术台向上指)并取弯屈(两腿放在胸前,双手抱住小腿)姿势,以分离上、下两个脊椎。

一个优选的操作规程为,先在两个棘突的中线处作一个小切口,再用一个扩展器将两个棘突撑开或分离开,再将切口向下朝手术台方向延伸并将分离单元802最好是向上插入到两个棘突840、842之间并保持住两个棘突的分离量。要将分离单元802向上推,直至从棘突的另一侧可以看到分离端或称球端808及槽806。看到球端808及槽806之后,要将切口向上朝离开手术台的方向扩展并将止动单元或称第二翼824插到槽806中,并用螺钉822将第二翼固定在应有位置中。完成这些步骤之后即可闭合切口。

一种选择的外科手术方法为,要求在两个棘突之间空间的两侧各作一个小切口。通过上切口用扩张器来撑开或分离开两个棘突。再通过下切口将分离单元802最好是向上插入到两个棘突840、842之间以这种方法推动棘突分开。要将分离单元802向上推,直至从病人后背上的第二小切口可以看到分离端或称球端808及槽806。看到球端808及槽806之后,再将切口向上朝离开手术台的方向扩展并将止动单元或称第二翼824插到槽806中,并用螺钉822将第二翼固定在应有位置中。完成这些步骤之后即可闭合切口。

以上两个外科规程的优点是外科医生可以观察到整个操作,他可以直接俯视到两个棘突而不是必须从两个棘突的左右两侧来观察手术过程。通常切口要开得尽可能地小,并且医生要在有血的和不稳定的环境下工作。因此,一种可以直接在医生的前面定位的嵌入物将比要求医生从一边移动到另一边的嵌入物更容易插入并装配。因此,一种按上面所述的路线进行的组织严密的途径是最佳的途径,因为医生可以在所有时间内看到整个嵌入过程的各个方面。这有助于医生在以下三个操作中进行有效的定位:(1)将分离单元定位在两个棘突之间,(2)将止动单元定位在分离单元中,(3)将定位螺钉定位在分离单元中。

图80a所示为分离单元的一个替换实施例802a。除了球端808a改为可从分离本体804a上拆去以外,分离单元802a与图80中的分离单元802相似。球端808a是靠螺纹固定在螺孔809内的。当分离单元802a按照与图86相关的叙述放到病人体内后便可将球端808a拆去。在一个优选实施例中,球端808a可以伸展在超过螺孔820约1毫米的地方。

图88、89、90及91所示实施例图88、89、90、91所示为本发明的另一个实施例。在这个实施例中,嵌入物以数字900表示。嵌入物900中与嵌入物800相似的其他元件用900系列中的相似数字表示。例如,分离单元用数字902表示,而这与嵌入物800中的分离单元802相对应。分离本体用数字904表示,这与嵌入物800中的分离本体804相对应。图90以透视图形式来描述分离单元902。分离单元902包括一个顶部宽于底部的槽906。槽906的上部宽度之所以大于第二翼924的宽度(图89),是因为可以让医生易于将第二翼放入槽906中,并且楔形的槽906可将第二翼924导入到最终位置。如图91所示,在翼924进入最终位置后,槽906的最大部分并没有被翼924完全充满。

嵌入物900的端头908的不同之处在于削得更尖。端头908具有两个倾斜角约为45°(本发明的精神包括从约30°到约60°)的侧边909、911以及一个小的平顶913,因此本体904可以更容易的推入到两个棘突之间。

分离单元902还包括一个舌形的凹坑919,该凹坑从槽906处开始伸展。在舌形凹坑里有一个螺孔920。

由图89可见,第二翼924包括一个舌片948,该舌片基本上垂直于第二翼924延伸并位于其上、下部926、928之间。舌片948包括一个孔950。当第二翼924进入分离单元902的槽906中并且舌片948落入凹坑919内时,定位螺钉922便可通过孔950定位而与螺孔920相连接,以把第二翼或止动单元924固定到分离本体902上。实施例900的嵌入方法与上述实施例800相同。另外,由于孔920基本上垂直于分离本体904(而不带有一个锐角),医生可以更容易的从两个棘突的正后方拧紧螺钉。

图92、92a、92b、93、93a、93b、93c、93d、94、94a、94b、95、95a及96所示实施例图92及92a所示为本发明的又一个实施例。在这个实施例中,嵌入物1000如图92a所见包括一个细长的中心体1002。中心体1002的一端有一个第一翼1004。第一翼1004与上述图88的实施例中的第一翼相似。在此实施例中,用螺栓1006将第一翼1004固定在本体1002上。在本体1002上有一个沿着本体的纵轴1008伸展的孔来容纳螺栓1006。不言而喻,这个实施例中的第一单元是由中心体1002、第一翼1004及导引头1010确定的。

也可以选择如图93c所示那样用一种压配及制动销的构造将第一翼固定在中心体上。在这种构造中,第一翼具有一个凸出物1040。凸出物1040最好与第一翼基本垂直并带有一个柔性的扣锁1042。该凸出物及柔性扣锁压配在中心体的孔1044中,扣锁落在制动销1046中。

在另一个实施例中,第一翼可设计成如图93d所示那样带有一个其方位与第一翼基本平行的凸出物,并有一个元件将该凸出物与该第一翼连接在一起。于是在这个实施例中,第一及第二翼按同一个方位插在本体上。

111.在中心体1002的另一端上有一个导引头1010。在这个具体的实施例中,导引头1010基本上是三角形的,因此是一个削尖的箭头状导引头。导引头1010也可以选择为沿着纵轴1008将两侧边截去的圆锥形。导引头1010包括一个凹口1012,凹口有螺孔1014。如下面将详细叙述,凹口1012的用途为容纳第二翼1032。

此外应理解,为了帮助将嵌入物1000插入相邻两个棘突之间,导引头1010可以是球形的、圆锥形的、削尖的、箭头形的等等。其优点是尽可能的减小插入技术对骨质和周围组织或韧带的扰乱,以使(1)减少手术位点的损伤促进早日康复,(2)不扰动正常的解剖学构造。这里指出,根据本实施例,不需要去除任何棘突的骨质;并且取决於病人的解剖学特性,有可能不需要去除或切断与两个棘突直接有关的韧带及组织。

嵌入物1000还包括一个套筒1016。套筒1016配装在中心体1002周围,并至少在部分区段上二者之间留有间隔。下面还将详细叙述,虽然嵌入物可能由诸如钛等生物相容材料组成,该套筒优选为由超弹性材料例如镍钛(NiTi)材料组成,这种材料可以在经受反复的曲折后恢复其原有位置而仍无疲劳迹象。套筒可用其它材料制造,例如钛,但这些材料不具有超弹性材料的优点。

图93a所示为嵌入物1000的横截面图,图中显示了中心体1002及套筒1016。从截面图93a可以看到,在一个优选实施例中中心体1002和套筒1016二者基本上都是圆柱形和卵形或椭圆形的。卵形或椭圆形截面可使有更多的棘突表面支靠在套筒上,因此套筒与骨质之间的载荷分布将更均匀。这就减小了骨质破坏或骨消溶的可能性。另外如下面所述,由于卵形或椭圆形截面套筒的长轴与棘突的纵向平行,因此增加了套筒的挠性。然而,其它形状的截面也包括在本发明的精神和范围之内。

在这个具体的实施例中,中心体1002包括有细长的沿着纵轴1008伸展的沟槽1018。沟槽1018用来容纳伸展在套筒1016内表面的细长的键1020。

在一个优选实施例中,中心体及套筒二者的截面都具有一个沿着轴1022的最大尺寸及一个沿着轴1024的最小尺寸(图93a)。键1020是沿最大尺寸的,因此套筒1016在沿最小尺寸的方向上具有相对中心体的最大挠曲。应该了解,中心体沿着最小尺寸1024可以具有多样的尺寸并可以,例如,减小厚度以增加套筒1016在中心体的这个方向上的挠曲性能。

图93b所示为一个替换实施例,其中中心体1002可包括键1020,而套筒1016可设计成包括沟槽1018,以合适地将套筒1016和中心体1002间隔开。

在其它实施例中,套筒可具有的最大及最小尺寸如下:

<tables id="table2" num="002"> <table>最小尺寸最大尺寸6毫米10毫米8毫米10.75毫米12毫米14毫米6毫米12.5毫米8毫米12.5毫米10毫米12.5毫米</table> </tables>在一个优选实施例中,所述套筒具有一个包括最大尺寸及最小尺寸的横截面,而所述最大尺寸大于所述最小尺寸并小于所述最小尺寸的约二倍。在所述实施例中,所述导引头具有与所述套筒相近的横截面,其中导引头的最大尺寸约等于所述套筒的最大尺寸,而导引头的最小尺寸约等于所述套筒的最小尺寸。另外在所述实施例中,从所述中心体上伸展有所述导引头,该导引头的横截面尺寸沿着离开所述中心体的方向而减小。

在另一个优选实施例中,所述导引头是圆锥形的,圆锥的底部位于紧贴所述套筒的地方。另外,所述导引头的底部横截面与所述套筒的卵形横截面基本相同。

以上所述说明,套筒的最大尺寸优选为与中心体的最大尺寸相对应,而套筒的最小尺寸优选为与中心体的最小尺寸相对应。还说明,套筒1016的最大尺寸,如图92a那样,与第一翼1004的沿其纵轴1030方向上的最大尺寸基本垂直。因此根据前面所述,当嵌入物1000正确地定位于两个棘突之间时,套筒的较大部分与上、下两个棘突相接触,以在牵伸脊柱时分散套筒1016上两个棘突的载荷。

如上面已经指出,套筒1016的最佳材料是一种超弹性材料,而更为优选的材料是由一种镍钛合金组成。这种材料的商品名称为Nitinol。其它的材料,只要是生物相容的并且具有与超弹性材料相同的一般特性,都可以使用。在这个具体实施例中,一种优选的超弹性材料的成分为:<tables id="table3" num="003"> <table>镍55.80%(重量)钛44.07%(重量)碳<0.5%(重量)氧<0.5%(重量)</table> </tables>实际上,这种成分的材料可以吸收约8%的可恢复应变。当然其它的可以吸收大于或小于8%可恢复应变的材料可以包括在发明的精神和范围之内。这种材料经过反复地向着中心体挠曲后仍能回复其初始形状而不疲劳。另外优选的是,这种材料在承受门限应力时仅具有很小的早期变形应变,而当超过该门限应力时却呈现出明显的并且几乎是即时的变形应变,这个变形应变高达所述很小的早期变形应变的许多倍。图118演示了这种特性,由图可见当超过某个门限应力水平时变形应变明显地即时的超过了约8%。图118所示为上述的典型超弹性材料在加载和卸载过程中的应力一变形应变曲线。

上述的超弹性材料优选为当两个棘突之间受到约20到50磅力的作用时可产生,例如约8%的变形。在牵伸棘突时这便可使套筒向中心体挠曲而将所产生的力中的绝大部分吸收掉。理想的情况下,套筒设计成在出现上述超弹性效应(受到门限应力水平)之前吸收20到100磅力。另外,取决于套筒的具体应用及病人个体的脊柱和两个棘突的解剖学上的具体情况,有可能将套筒设计成在到达门限应力水平之前吸收20到500磅力的最佳范围。实验结果显示,一个老年个体的棘突当受到400磅力的作用时便可能破坏。实验结果还指出,当作用以至少100磅力时棘突可能经历某种程度的压缩。因此,理想情况下超弹性材料应设计成在小于100磅力的作用下产生明显的变形或挠曲。

在一个优选实施例中,套筒的壁厚为约1毫米或40/1000英寸(0.040英寸)。套筒最好设计成经受1毫米的总挠度。1毫米总挠度的意思是在最小尺寸的顶部及底部各产生0.5毫米的朝向中心体的挠度。

在一个具体的实施例中,其中套筒的横截面更接近圆形,套筒的外径为0.622英寸壁厚为0.034英寸,在20磅力载荷下挠度为0.005英寸,在60磅力载荷下挠度为0.02英寸(约0.5毫米)。一个100磅力的载荷将造成约0.04英寸或约1毫米的挠度。

概括以上所说,使用上述优选的超弹性材料意味着套筒可以经过反复地曲折后恢复其原有的形状而不呈现出疲劳迹象。套筒可以在一个很小的变形应变的情况下承受一个门限应力,而在所述门限应力附近又呈现出明显的相当于所述很小的变形应变许多倍的即时变形应变。换句话说,这种超弹性性质意味着这种材料工作在应力一应变曲线的平稳段上,在这里,如图118所示,材料在很大的应变范围内支撑一个常值的力(应力)。

应该了解,对于这个具体的实施例,先要将超弹性材料的棒状毛坯机械加工成合适的形状,然后经热处理到最终温度以给材料赋形,亦即将材料升温至932°F并保温五(5)分钟再将套筒在水中进行快速淬火。还应了解,最好在现有的镍钛超弹性合金中选择转变温度Af为约59°F(15℃)的合金。对于这种器件转变温度一般在15℃到65℃(59°F到149°F)之间,更好一些的为10℃到40℃(50°F到104°F)之间。优选材料的转变温度应低于其在体内所处的温度以呈现其最佳的弹性性质。

备选的也是优选的加工套筒的方法是金属丝放电加工方法(EDM),这种方法比机械加工方法更好。此外,套筒可以用喷丸技术来进行最终加工以提高套筒的弹性及表面强度。

图94及95所示为第二翼1032的顶视图及侧视图。与前几个实施例一样,第二翼1032包括一个舌片1034。舌片1034带有一个与导引头1010上的孔1014对准的孔1036。在这个具体的实施例中,第二翼1032包括一个缺口1038。缺口1038的尺寸与导引头1010相吻合,而舌片1034则落入导引头1010上的凹口1012中。

图94a所示为第二翼1032的一个备选的形状。在这个形状中,第二翼1032与舌片1034成锐角。图94及95中的实施例则与此不同,其中的第二翼基本上垂直于舌片。对于某些形状的棘突,使用如图94a第二翼的实施例是合适的。

图94b及95a所示为又一个替换的第二翼1032。在图94b中,加长的舌片1034上具有多个互相靠得很近的孔1036。这样,孔便成为扇形。孔1036的每个扇形部分都可以选择用来容纳螺钉,以有效地将第二翼1032布置在相对于第一翼1004的三个不同的位置上。图95a替换实施例中的缺口1038比图95中的缺口有所放大,因为在与第一翼1004最为接近的位置上第二翼1032是直接紧贴在套筒1016上的,因此必须与它的形状相一致。

图97所示实施例图97中的嵌入物1050与图92中的嵌入物1000相似,其主要的不同点在于不需要第二翼。嵌入物1050与嵌入物1000一样包括一个中心体。该中心体的周围有一个套筒1016伸展在第一翼1004和导引头1010之间。这个实施例中的导引头1010基本上是圆锥形的。因为没有必要容纳第二翼因此没有任何平坦部分也没有孔。套筒、中心体、第一翼及导引头的情况与图92中的嵌入物1000的相应部分相似。不言而喻的是穿过套筒1016处嵌入物1050的横截面同样可以优选为如图93a所示。这个特殊的实施例将可用在预计不必使用或不可能使用第二翼的场合。这个实施例由于采用了超弹性合金材料制造套筒,及用导引头来引导嵌入物进入两个棘突之间位置,因此同样具有这二者所带来的显著优点,同时对两个棘突周围的组织结构及韧带损伤最小。

图98所示实施例图98所示的嵌入物1060除了没有第一及第二两个翼以外,与图92中的嵌入物1000及图97中的嵌入物1050相似。嵌入物1060包括一个包围在中心体外面的套筒1016,该中心体与图93嵌入物1000的中心体1002相同。不言而喻的是嵌入物1060穿过套筒1016处的横截面同样可优选为如图93a所示。嵌入物1060包括一个导引头1010,在这个优选实施例中该导引头是圆锥形的。导引头1010位于中心体的一端,在中心体的另一端为阻止件1062。阻止件的用途为容纳套筒1016的另一端以保持其与中心体的相对位置。在这个实施例中使用了一个象前面两个实施例所用的图93中的螺钉1006那样的螺钉将以上元件夹在一起。对于图98所示嵌入物1060,这种器件适用于两个棘突之间的解剖学构造不要求采用第一及第二两个翼的场合。但这个实施例同样具有与导引头及套筒的机械力学性能有关的所有优点。

图99及100所示实施例图99及100所示为一个嵌入物系统1070。嵌入物系统1070包括一个与图92实施例的套筒1016相似并具有其所有优点的套筒1072,然而套筒1072没有任何键。另外,嵌入物系统1070包括一个插入工具1074。插入工具1074包括一个导引头1076。在一个优选实施例中导引头1076基本上是圆锥形的。导引头1076的用途为将套筒1072及插入工具1074引导进入两个棘突之间。插入工具1074还包括一个中心体1078、阻止件1080及一个手柄1082。导引头1076的底部尺寸稍小于套筒1072的内面尺寸,以使套筒1072可以适配在导引头1076上并座落在阻止件1080上。用带有导引头1076的工具1074来分开组织及韧带,并将套筒1072推到两个棘突之间的空间内。一旦就位,即可将导引插入工具1074取走而将套筒1072留在应有位置上。套筒就位以后,如果需要,可以用一个插管通过套筒1072的中心插入几个诸如弹簧丝1084那样的位置保持机构。弹簧丝1084可以用合适的材料,诸如超弹性合金及包括钛在内的其他材料制造。插入之后,止动弹簧丝1084的两端伸出套筒1072的两端之外(见图99),并且由于它的弹簧特性而弯曲并与套筒1072的纵轴成一个角度。这些弹簧丝有助于使套筒保持其与两个棘突的相对位置。

图101、102、102a、103、104、105、106及107所示实施例图101所示为本发明的另一个实施例。该实施例包括一个嵌入物1100,该嵌入物具有许多与图92中的嵌入物1000相似的零件。据此,具有相似零件和功能的元件将赋以相似的编号。另外,不同于嵌入物1100的零件,如果需要,也可表示在图中变成为图92嵌入物1000的一部分。

和嵌入物1000一样,嵌入物1100包括一个带有第一翼1004及螺钉1006的中心体1002(图102)。螺钉1006将第一翼1004及中心体1002夹持在一起。在这个具体的实施例中,中心体由两部分组成。第一部分1102为一个底面为卵形或椭圆形的截锥体,第二部分1104包括一个柱形的中心部分,其远端为卵形或椭圆形底面的截锥体1103。此外,在这个具体的实施例中,有一个卵形或椭圆形底面的导引头1010与中心体形成在一起。螺钉1006是用来将第一翼固定在第二部分1104上并将第一部分1102夹持在中间。在这个具体的实施例中,导引头1010除了包括凹口1012及孔1014以外还包括一个槽1106。槽1106容纳第二翼1032的一部分。

在这个具体的实施例中,套筒1016如图102a所示优选为卵形或椭圆形的。中心体的截面形状可以是卵形、椭圆形或圆形的,虽然其它形状也包括在本发明精神和范围之内。由于截锥体部分1102以及相应的截锥体部分1103二者的底面都是卵形或椭圆形的,因此便将套筒1016夹持在应有位置上。最好是将套筒1016夹持在这样的位置上,即套筒椭圆形截面的长径基本上垂直于第一翼的最大尺寸。应该理解,如果预定要将第一翼放在脊椎骨以外的地方因而设定第一翼最大尺寸的方向不与脊椎骨相垂直,这时就可能要将套筒夹持在这样的位置上,即套筒椭圆形截面的长径不再垂直于第一翼的最大尺寸,这样的配置仍包括在本发明的精神及范围之内。这样的配置可以通过下述方法来达到:先将套筒1016及第一翼1004放到所要求的位置上然后拧紧螺钉1006。在这样配置的情况下,仍优选为将套筒的长径放到与相邻两个棘突的长度基本平行的位置上。这样,卵形或椭圆形的套筒能以其较大的表面来承受并更均匀地分散载荷。

可理解,该实施例中的套筒同样具有上述与上面提到过的超弹性套筒有关的一切特征与优点。

第二翼可以如前面已叙述过的那样备有多种形状,以供不同解剖学形状的棘突选用。图103、104、105、106及107对这些形状进行了描述。在各种形状中,第二翼1032都具有上部1108及下部1110。在图104中,下部较上部更厚以适应下棘突比上棘突更薄的情况。在图105中,上、下两个部分的厚度比图103中的上、下部分的厚度有所增加,这是为了适应上、下两个棘突都较小的情况。也就是说,由于第二翼上、下部分厚度的增加,第一及第二翼的上、下部分之间的间隔减小了。

图106、107所示的第二翼为图104及105所示第二翼的替换实施例。与图106、107中的第二翼1032相适应的棘突与图104、105中的第二翼所适应棘突二者的解剖学形状及尺寸是相同的。然而,在图106、107所示第二翼1032的实施例中,已经从翼上去掉了大块的材料。其中的上、下两个部分1108和1110已经明显的形成或弯曲,为从第二翼1032的中间部分1112延伸。

不言而喻,在这个实施例中,对于某些解剖学构造的脊柱,第二翼不是必须采用。这时,该实施例同样具有导引头1010及套筒1016的功能所带来的显著优点。

图108、109及110所示实施例图108、109所示嵌入物1120,与嵌入物1100相似并转而与嵌入物1000相似。前面已经叙述过的关于相似的详细情况可供这里参考。第一及第二翼1122、1124具有特殊的取向,这两个翼具有相应的纵轴1126及1128。如从图中所见,两个翼1122、1124已经转动而向内倾斜,如果将两个翼面展宽到图108的纸面以外,二者则相交而形成如端视图图109所示的A字形框架结构。如图109、110所示,在这个具体的实施例中,舌片1034与第二翼1124的其它部分成一锐角。另外嵌入物中的沟槽1018也是倾斜的以容纳倾斜的第二翼1124。如果两个棘突其邻近脊椎体处的间隔较宽,而向离开脊椎体的方向至少行经某个距离处的尺寸较窄,在这种情况下,本嵌入物1120就特别适用。不言而喻的是嵌入物1120穿过套筒1016处的横截面同样可优选为如图93a所示。

图111、112、113、114、115、116及117所示实施例图111所示为嵌入物的另一个实施例1150。嵌入物1150具有与图94b所示相似的零件。

嵌入物1150包括一个带有第一翼1154的中心体1152。其中的中心体1152包括一个细长的沟槽1156。沟槽1156一直伸展到导引头1158。在沟槽1156中有一个孔用来容纳螺钉1160。

第二翼1162包括一个中心体1164。中心体1164基本上垂直于第二翼1162。

中心体1164中包括有多个孔1166。这些孔相互靠得很近以形成多个扇形,每个扇形都可以夹持螺钉1160。如图114所示,第二翼包括有一个缺口1168。因此当第二翼的中心体1164被容纳在与第一翼相连的中心体的沟槽1156中时,第二翼的其余部分便座落在嵌入物1150的中心体1152上。这样,只要在多个孔1166形成的五个扇形中选择一个让螺钉1160穿过,便可调节嵌入物1150第一及第二翼之间的距离。根据这个方法,图112所示即为将嵌入物的第一及第二翼的间隔调到最大以适应较大厚度的棘突。而图111所示为将嵌入物的第一及第二翼的间隔调到中间值以适应平均尺度的棘突。

可理解,在进行外科程序时最好先将中心体1152推入两个棘突之间。然后从两个棘突的另一侧导入第二翼,使第二翼的翼面按着基本平行于第一翼翼面的方式移动,直至第二翼1162的中心体1164落入第一翼1154的中心体1152的槽1156中。此后再将螺钉1160放入第二翼1162的对准孔以及中心体1152中,以将第二翼固定在中心体上。

虽然实施例1150中没有描述如套筒1016那样的套筒,但这种套筒1016同样可放到中心体1152上,而且仍在本发明的精神及范围之内。

工业应用性由上所述,证明本发明可用来缓解由如中心管狭窄或侧向孔狭窄等形式的脊椎狭窄所造成的疼痛。本发明的嵌入物可以使脊椎的固有弯曲变平,并可张开神经孔及相邻脊椎骨之间的间隔,从而缓解与上述侧向孔和中心管狭窄有关的问题。另外,本发明可以用来缓解与小平面关节病变有关的疼痛。本发明对人体损伤最小并可在门诊的条件下应用。

本发明的其它方面,目的及优点可通过阅读权利要求及附图得知。

可以理解,还可在权利要求的精神和范围内制造出其它的许多实施例。

Claims (70)

1.一种用来缓解与脊柱有关的疼痛的嵌入物,该嵌入物可以放在脊柱的相邻两个棘突之间,所述嵌入物包括:一个第一单元,第一单元包括一个中心体、一个导引头及一个第一翼,所述第一翼位于所述中心体的第一端,而所述导引头从远离所述第一翼的所述中心体的第二端上伸展;一个套在所述中心体上的套筒,所述套筒至少部分地与所述中心体间隔开,以使所述套筒可以向所述中心体挠曲;一个第二翼;以及一个将第二翼固定到第一单元上的器件。
2.如权利要求1的嵌入物,其中所述套筒是筒形的并且其横截面为卵形的。
3.如权利要求1的嵌入物,其中所述套筒是筒形的并且其横截面具有一个最大尺寸及一个最小尺寸。
4.如权利要求3的嵌入物,其中所述最大尺寸基本上垂直于所述第一翼的最大长度。
5.如权利要求1的嵌入物,其中所述套筒由超弹性材料组成。
6.如权利要求1的嵌入物,其中所述套筒由超弹性的镍钛合金组成。
7.如权利要求1的嵌入物,其中所述中心体具有至少一条细长的沟槽;并且所述套筒包括至少一条内凸的键,该键容纳在所述沟槽中以将所述套筒与所述中心体间隔开。
8.如权利要求7的嵌入物,其中所述套筒具有一个横截面,所述横截面具有一个最大尺寸及一个最小尺寸;所述第一翼具有一个最大尺寸;以及所述键容纳在所述沟槽中,因而所述套筒的所述最大尺寸基本垂直于所述第一翼的所述最大尺寸。
9.如权利要求1的嵌入物,其中所述套筒包括至少一条内凸的键,该键可以与所述中心体相接触,以将所述套筒与所述中心体间隔开。
10.如权利要求1的嵌入物,其中所述中心体包括至少一条外凸的键,该键可以与所述套筒相接触,以将所述套筒与所述中心体间隔开。
11.如权利要求1的嵌入物,其中所述导引头是尖的,以使所述中心体可在不改变两个棘突的情况下被推到两个棘突之间。
12.如权利要求1的嵌入物,其中所述套筒具有一个横截面,所述横截面具有一个最大尺寸及一个最小尺寸,并且所述最大尺寸大于所述最小尺寸,并小于所述最小尺寸的二倍,并且所述导引头具有一个与所述套筒接近的横截面,所述横截面具有一个约等于所述套筒最大尺寸的导引头最大尺寸,及一个约等于所述套筒最小尺寸的导引头最小尺寸;并且从所述中心体上伸展出所述导引头,所述导引头的横截面尺寸沿离开所述中心体的方向而减小。
13.如权利要求2的嵌入物,其中所述导引头是锥形的,所述导引头的底面紧贴所述套筒,并具有与所述套筒的卵形横截面基本相同的横截面。
14.如权利要求1的嵌入物,其中所述导引头基本上是锥形的。
15.如权利要求1的嵌入物,其中所述第二翼具有一个缺口,所述缺口容纳在所述导引头上。
16.如权利要求1的嵌入物,其中所述器件包括一个从所述第二翼伸展出的舌片;以及所述器件包括一个将所述舌片固定在所述导引头上的紧固件。
17.如权利要求1的嵌入物,其中所述第一翼和所述第二翼中至少有一个翼绕着最大尺寸转动,以对所述中心体倾斜一个锐角。
18.如权利要求1的嵌入物,其中所述器件允许所述第二翼可以以多个构形固定到所述第一单元上,因此所述第一及第二翼之间的间隔是可供选择地变化的。
19.如权利要求1的嵌入物,其中所述中心体具有锥形的端头,该锥形端头使得所述套筒在所述中心体的至少一段上与所述中心体保持有间隔,因此所述套筒可以向所述中心体的所述至少一段挠曲。
20.如权利要求1的嵌入物,其中组成所述套筒的材料可以吸收约8%的可恢复伸长。
21.如权利要求1的嵌入物,其中所述套筒可在20磅到50磅力的作用下产生挠曲。
22.如权利要求1的嵌入物,其中所述套筒可经过反复挠曲并可回复其初始形状。
23.如权利要求1的嵌入物,其中所述套筒可以承受一个门限应力而呈现一个小的变形应变,而在所述门限应力以上则呈现出明显的相当于所述小的变形应力许多倍的即时变形应变。
24.如权利要求1的嵌入物,其中所述第二翼包括从中部伸展出的上部及下部,并且所述上部及下部二者中至少有一个相对于所述中部弯曲,因此与所述第二翼的中部相比所述上部及下部二者中的至少一个和所述第一翼靠得更近些。
25.一种用来缓解与脊柱有关的疼痛的嵌入物,该嵌入物可以放在脊柱的相邻两个棘突之间,所述嵌入物包括:一个包括有中心体的第一单元,一个位于所述中心体第一端的导引头,以及一个位于所述中心体第二端的阻止件;一个套在所述中心体上的套筒,所述套筒至少部分地与所述中心体间隔开,以使所述套筒可以向所述中心体挠曲;以及所述套筒被夹持在所述导引头及所述支撑件之间。
26.如权利要求25的嵌入物,其中所述导引头基本上是锥形的。
27.如权利要求25的嵌入物,其中所述阻止件是第一翼。
28.如权利要求25的嵌入物,其中所述套筒的横截面是卵形的。
29.如权利要求25的嵌入物,其中所述套筒具有一个横截面,所述横截面具有一个最大尺寸及一个最小尺寸。
30.如权利要求25的嵌入物,其中所述套筒由超弹性材料组成。
31.如权利要求25的嵌入物,其中所述套筒由超弹性的镍钛合金组成。
32.如权利要求25的嵌入物,其中所述细长的中心体具有至少一条细长的沟槽;并且所述套筒包括至少一条内凸的键,该键容纳在所述沟槽中以将所述套筒与所述中心体间隔开。
33.如权利要求25的嵌入物,其中所述套筒包括至少一条内凸的键,该键可以与所述中心体相接触,以将所述套筒与所述中心体间隔开。
34.如权利要求25的嵌入物,其中所述中心体包括至少一条外凸的键,该键可以与所述套筒相接触,以将所述套筒与所述中心体间隔开。
35.如权利要求25的嵌入物,其中所述导引头是尖的,以使所述中心体可在不改变两个棘突的情况下被推到两个棘突之间。
36.如权利要求25的嵌入物,其中所述套筒具有一个横截面,所述横截面具有一个最大尺寸及一个最小尺寸,并且所述最大尺寸大于所述最小尺寸,并小于所述最小尺寸的二倍,以及所述导引头具有一个与所述套筒接近的横截面,所述横截面具有一个约等于所述套筒最大尺寸的导引头最大尺寸,及一个约等于所述套筒最小尺寸的导引头最小尺寸;并且从所述中心体上伸展出所述导引头,所述导引头的横截面尺寸沿离开所述中心体的方向而减小。
37.如权利要求25的嵌入物,其中所述导引头是锥形的,所述导引头的底面紧贴所述套筒并具有与所述套筒的卵形横截面基本相同的横截面。
38.如权利要求25的嵌入物,其中所述中心体具有锥形的端头,该端头使得所述套筒在所述中心体的至少一段上与所述中心体保持有间隔,因此所述套筒可以向所述中心体的所述至少一段挠曲。
39.如权利要求25的嵌入物,其中组成所述套筒的材料可以吸收约8%的可恢复伸长。
40.如权利要求25的嵌入物,其中所述套筒可在20磅到50磅力的作用下产生挠曲。
41.如权利要求25的嵌入物,其中所述套筒可经过反复挠曲并可回复其初始形状。
42.如权利要求25的嵌入物,其中所述套筒可以承受一个门限应力而呈现一个小的变形应变,而在所述门限应力以上则呈现出明显的相当于所述小的变形应力许多倍的即时变形应变。
43.一种用来缓解与脊柱有关的疼痛的嵌入物,该嵌入物可以放在脊柱的相邻两个棘突之间,所述嵌入物包括:一个可以向内挠曲的套筒;一种插入工具,所述插入工具包括一个导引头、一个中心体、一个阻止件及一个手柄,其中所述导引头及所述阻止件从所述中心体的相对立的两侧伸展,而所述手柄从所述阻止件上伸展;以及其中所述套筒适配在所述导引头上,并支靠在所述阻止件上,以准备与插入工具一起放置在相邻两个脊椎骨之间。
44.如权利要求43的嵌入物,其中所述导引头基本上是锥形的。
45.如权利要求43的嵌入物,其中所述套筒具有第一及第二端、一条纵轴及至少一条贯穿所述套筒的柔性金属丝,所述金属丝各有一部分伸出在所述第一端及所述第二端之外;所述柔性金属丝的所述各伸出部分不与所述纵轴平行。
46.如权利要求43的嵌入物,其中所述筒形套筒的横截面是卵形的。
47.如权利要求43的嵌入物,其中所述筒形套筒具有一个横截面,所述横截面具有一个最大尺寸及一个最小尺寸。
48.如权利要求43的嵌入物,其中所述筒形套筒由超弹性材料组成。
49.如权利要求43的嵌入物,其中所述筒形套筒由超弹性的镍钛合金组成。
50.如权利要求43的嵌入物,其中所述导引头是尖的,以使所述中心体可在不改变两个棘突的情况下被推到两个棘突之间。
51.如权利要求43的嵌入物,其中组成所述套筒的材料可以吸收约8%的可恢复伸长。
52.如权利要求43的嵌入物,其中所述套筒可在20磅到50磅力的作用下产生挠曲。
53.一种用来缓解与脊柱有关的疼痛的嵌入物,该嵌入物可以放在脊柱的相邻两个棘突之间,所述嵌入物包括:一个包括有中心体及第一翼的第一单元;一个第二翼;以及一种将所述第二翼可选择地固定到所述细长中心体的多个位置上的装置,为调整所述第一及第二翼之间的间隔以适应不同尺寸的棘突。
54.如权利要求53的嵌入物,其中所述第二翼的所述固定装置具有一个带有多个孔口的中间段,通过所述的孔口可将所述第二翼可选择地定位到所述中心体上。
55.一种用来缓解与脊柱有关的疼痛的嵌入物,该嵌入物可以放在脊柱的相邻两个棘突之间,所述嵌入物包括:一个第一单元,第一单元包括一个中心体及一个第一翼,所述第一翼位于所述中心体的第一端,所述中心体具有一个第二端;一个套在所述中心体上的套筒,所述套筒至少部分地与所述中心体间隔开,以使所述套筒可以向所述中心体挠曲;一个第二翼;以及一个将第二翼固定到中心体的第二端上并将所述套筒夹持在第一及第二翼之间的器件。
56.如权利要求55的嵌入物,其中所述套筒的横截面为卵形。
57.如权利要求55的嵌入物,其中所述套筒具有一个横截面,所述横截面具有一个最大尺寸及一个最小尺寸。
58.如权利要求55的嵌入物,其中所述最大尺寸基本垂直于所述第一翼的最大尺寸。
59.如权利要求55的嵌入物,其中所述套筒由超弹性材料组成。
60.如权利要求55的嵌入物,其中所述套筒由超弹性的镍钛合金组成。
61.如权利要求55的嵌入物,其中所述第一翼和所述第二翼中至少有一个翼绕着最大尺寸转动,以对所述中心体倾斜一个锐角。
62.如权利要求55的嵌入物,其中所述器件允许所述第二翼可以以多个构形固定到所述第一单元上,因此所述第一及第二翼之间的间隔是可供选择地变化的。
63.如权利要求55的嵌入物,其中组成所述套筒的材料可以吸收约8%的可恢复伸长。
64.如权利要求55的嵌入物,其中所述套筒可在20磅到50磅力的作用下产生挠曲。
65.如权利要求55的嵌入物,其中所述套筒可经过反复挠曲并可回复其初始形状。
66.如权利要求55的嵌入物,其中所述套筒可以承受一个门限应力而呈现一个小的变形应变,而在所述门限应力以上则呈现出明显的相当于所述小的变形应力许多倍的即时变形应变。
67.一种用来缓解与脊柱有关的疼痛的嵌入物,该嵌入物可以放在脊柱的相邻两个棘突之间,所述嵌入物包括:一个可以向内挠曲的套筒,该套筒可以放在相邻两个脊椎骨之间;以及所述套筒是由超弹性材料组成。
68.如权利要求67的嵌入物,其中所述套筒具有第一及第二端、一条纵轴及至少一条贯穿所述套筒的柔性金属丝,所述金属丝各有一部分伸出在所述第一端及所述第二端之外;所述柔性金属丝的所述各伸出部分不与所述纵轴平行。
69.如权利要求67的嵌入物,其中所述套筒由超弹性的镍钛合金组成。
70.如权利要求67的嵌入物,其中组成所述套筒的材料可以吸收约8%的可恢复伸长。
CN 98811736 1997-01-02 1998-10-21 脊椎分离嵌入物 CN1167387C (zh)

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