CN102462562A - 具有柔韧性的椎间融合器 - Google Patents
具有柔韧性的椎间融合器 Download PDFInfo
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- CN102462562A CN102462562A CN2011100494949A CN201110049494A CN102462562A CN 102462562 A CN102462562 A CN 102462562A CN 2011100494949 A CN2011100494949 A CN 2011100494949A CN 201110049494 A CN201110049494 A CN 201110049494A CN 102462562 A CN102462562 A CN 102462562A
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- Prior art keywords
- elastic
- fusion device
- skeleton
- invasive lumbar
- lumbar fusion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- A—HUMAN NECESSITIES
- 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
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- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
- A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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Abstract
本发明涉及一种具有柔韧性的椎间融合器。该椎间融合器,由具有固有弹性的板簧形成构成融合器的骨架,对上述骨架赋予形状记忆特性,以便获得相应于每个患者的腰部负载的弹性系数,由此缓解施加到脊椎的冲击,并还原椎间盘间隔而确保足够的椎间间隔,从而可消除脊椎神经压迫,并将融合器的使用目的,从单纯的融合作用代替为适合于生物体的正常椎间盘作用。本发明提供一种包括骨架的具有柔韧性的椎间融合器,上述发挥自身的固有弹性的骨架,形成具有空心的中空部的闭合截面,缓解患者因直立行走时的动态运动而沿脊椎的垂直方向施加的压迫所产生的负载,由此代替正常椎间盘的作用。
Description
技术领域
本发明涉及一种用于治疗椎间盘的人造椎间盘,尤其涉及具有柔韧性的椎间融合器,该椎间融合器缓解手术后施加到脊椎的冲击,并控制椎间运动而维持脊柱矢状面平衡(spinal sagittal balance)的同时充分维持椎间盘的间隙,以消除针对脊椎神经的压迫。
背景技术
一般而言,正常椎间盘起着缓解施加到脊椎的冲击并限制椎间运动而保护脊椎神经的作用。
常见疾病之一的椎间盘疾病,包括因腰部受到严重的冲击而导致椎间盘突出的腰椎间盘突出症和因脊椎骨之间的椎间盘(intervertebraldisk)老化而压迫周边神经组织的退变性椎间盘疾病等。
如果脊椎疾病中的椎间盘退变性变化(老化现象)严重,则椎间盘的固有功能将会逐渐丧失,会容易受到冲击而引发疼痛。并且,成为椎间不稳定的因素而压迫脊椎神经,由此加重疼痛。
针对脊椎疾病中的腰椎间盘突出症,通过现有的椎间盘手术也能达到治疗目的,但在退变性椎间盘疾病的情况下,一直以来很难治愈。这是因为由于患有退变性椎间盘疾病的患者大多数为中老年人,所以往往同时患有糖尿病、高血压、心脏病等成人病。然而,自从发表最新开发的脊椎骨融合术的临床案例以来,给以往难以治愈的退变性椎间盘疾病的治疗带来了新的局面。
另一方面,当外科医生对患有脊椎退变性疾病或椎体不稳定性疾病的患者进行手术时,在仅使用腰椎后方动态固定器具的情况下,会发生反常的负荷转移模式,因此基于运动的大部分压力与腰椎后方动态固定器具对准。这将是与脊椎手术相关的最重要的失败因素。尤其是,在腰椎后方动态固定器具由硬杆构成的情况下,根据应力遮断效应(stressshielding effect)给脊椎带来更大的不良影响。其结果,做脊椎手术时需要用于前侧稳定化的融合器的融合。
用于治疗脊椎疾病的脊椎骨融合术是在1992年开发于美国之后,1996年从美国食品及药物管理局(FDA)认可其安全性、有效性的最尖端的技术,在韩国国内做过很多这种手术。
上述脊椎骨融合术是如下的技术:在患有脊椎疾病的椎间插入由对人体无害的材质例如钛等材质制造的金属融合器而确保空隙,由此消除腰部疼痛。也就是说,去除因老化而在脊椎骨之间无法执行真正作用的椎间盘之后,在其位置上移植不引起人体排斥反应的圆筒形的人造椎间盘螺纹融合器T.F.C(Thread Fusion Cage)。
使用该脊椎骨融合术的目的在于,先去除退变的椎间盘之后,在椎间插入融合器而确保空隙,并在椎间周围移植骨而达到椎间的完全融合。其结果,椎间运动被停止,完全丧失正常椎间盘功能,因此融合之后造成另一个问题。也就是说,起到了促进连接部位的退变性变化的作用。
另一方面,随着年龄的增长等而人体的脊椎状态不同,因此治疗椎间盘疾病时,应当使用适合患者状态的椎间融合器。但是,以往的椎间融合器并非是与患者的多种脊椎状态对应地可以改变的结构,只是进行了选择适当大小的椎间融合器并使用这种程度的千篇一律的移植手术,从而存在不能进行准确的手术的根本性的限制。
并且,以往的椎间融合器,存在由于移植手术中需要复杂的多种操作设备难以实行顺利的手术、由于伴随大而复杂的手术设备的移动而在手术过程中很可能给脊椎神经组织带来不良影响、需长时间进行复杂的手术等难解的问题。
为了解决上述问题,韩国专利公开第10-2004-0064577号提出了如下的可变式人造椎间盘:如图1所示,该椎间融合器具备由支撑圆筒状框架的凸台部103和与该凸台部103结合并沿放射方向扩张的独立板104构成的骨架102,在形成于上述独立板104的裂缝106内部设置外螺纹,并根据旋转上述外螺纹的动作,以放射状扩张独立板104。当为了维持患者脊椎的适当的弯曲状态而在所移植的椎间融合器的前端和后端之间需要有高度差时,上述结构根据所期望的间隔进行调节的同时进行移植,由此可根据患者状态进行适当的治疗。
但是,上述结构虽然可调节椎间高度差间隔,然而由于是以融合为目的使用,从而出现椎间运动被停止而不能应对连接部位的退变性变化的问题。
并且,美国专利注册第6964686号中提出了如下结构的椎间盘替换用假肢机构:如图2所示,在形成有轴向空腔204的骨架202的外周面上形成呈弹簧形态及起着弹簧功能的裂缝206,并在上述骨架202的轴向空腔204内,插入了呈凸出形态的下部椎间盘支架208和上部椎间盘支架210,该上部椎间盘支架210形成有用于对上述下部椎间盘支架208的凸出形状进行容纳的凹槽。这种结构是脊椎随着对上部脊椎盘支架进行按压而通过骨架的裂缝以下部脊椎盘支架为中心进行缓冲的结构。
虽然上述结构,根据骨架的裂缝发挥缓冲功能,但无法确保足够的椎间盘间隔,并且,只能以上下方向缓冲,因此不能控制脊椎以自由方向运动,从而发挥维持脊柱矢状面平衡的椎间盘固有的功能是有限度的。
此外,作为目前所知的以融合为目的的传统融合器,提出了由被命名为Ti6Al4V的钛合金或Peek(Polyetheretherketone)的合成树脂材料构成的模块化的融合器。
但是,上述融合器,手术后出现根据患者的运动效果而塌陷到椎体的倾向。众所周知,上述Peek的弹性系数大于Ti6Al4V的弹性系数,与椎体终板类似。上述Peek材质模块融合器,与Ti6Al4V模块融合器相比时,更加延迟了塌陷到椎体内的时间,因此更受到好评。上述Peek材质融合器的椎体塌陷率达到20-30%左右,优于Ti6Al4V模块融合器的40-60%的椎体塌陷率。但是,如果医生给患有骨质减少(osteopenia)或骨质疏松症(osteoporosis)的患者使用Peek材质的模块融合器,术后经过几年,依然不能摆脱融合器塌陷的问题。
发明内容
鉴于上述诸般问题,本发明的目的在于,提供一种适合于生物体、可代替正常椎间盘作用的具有柔韧性的椎间融合器。
并且,本发明的另一目的在于,提供一种具备柔韧性的椎间融合器,将构成融合器的骨架自身构成为具有固有弹性的板簧形态,给骨架赋予形状记忆特性,以便获得相应于每个患者的不同腰部负载的弹性系数,由此缓解施加到脊椎的冲击,并还原椎间盘间隔而充分确保椎间间隔,从而可消除脊椎神经压迫。
并且,根据本发明的椎间融合器,可在狭窄的椎间,容易进行手术,并具备适当的柔韧性。
并且,使骨架自身有弹性地移动,由此控制椎间自由方向移动,从而可维持脊柱矢状面平衡。
并且,比起通过以往的完全融合停止运动而破坏矢状面平衡(sagittal balance)、椎间盘固有的功能被损坏的固定功能,可稍微恢复生理上适合的正常椎间盘的功能。
为实现上述目的,本发明的一个实施例,提供包括发挥自身固有弹性的骨架的具有柔韧性的椎间融合器。上述骨架,形成具有空心的中空部的闭合截面,并缓解患者因直立行走时的动态运动而沿脊椎的垂直方向施加的压迫所产生的负载,以便代替正常椎间盘的作用。
上述骨架,其特征在于,包括:第一弹性部,其通过内部空间而沿上下方向进行缓冲;第二弹性部,其以从第一弹性部的一侧面朝向中空部凹进的方式形成,并与第一弹性部一起提供缓冲力。
上述第一及第二弹性部,其特征在于,实质上由具有U字形或W字形的闭合截面的椭圆形板簧形成。
并且,上述骨架,其特征在于,由选自钛合金或镍钛合金(Nitinol)中的一个材质形成,给骨架的第一及第二弹性部赋予形状记忆特性。
本发明的另一个实施列,提供包括骨架及夹板(clip plate)的具有柔韧性的椎间融合器。上述骨架,由空心的中空截面的椭圆板形成,形成有一侧开放的形状的开放部,并发挥自身的固有弹性;上述夹板,通过上述骨架的开放部插入在中空部内表面,并与上述骨架的缓冲联动而缓冲。
在此,上述骨架和夹板中的任意一个,由具有形状记忆特性的钛合金或镍钛合金形成,而另一个由钛合金形成。
如上所述,根据本发明的特征,将其融合器的效果分为功能上的效果和手术观点上的效果,其综合的效果为没有负载施加到脊椎时的应力遮断效应的状态下,形成生理学上良好的负载传达(分配)模式,并根据冲击缓冲机制,使融合器塌陷在椎体内的比率减少为约10%以下,根据沃尔夫定律(Wolff’s Law),在椎体终板和融合器之间体现良好的稳定性(融合性),根据融合器的板簧特性和镍钛合金的材质特性发挥强的支撑力。
下面,对上述效果进行更详细的说明。
第一,使闭合截面的骨架自身具有弹性,以便缓冲朝上下侧施加的冲击而缓解施加到脊椎的冲击,通过骨架自身的弹性特性,以相应于正常椎间盘间隔的空隙充分确保椎间盘间隔,从而可消除脊椎神经压迫。
第二,如果融合器具有较弱的支撑力,则不能维持与椎间盘高度相应的高度,并且,不能敞开侧面孔,但是,本发明根据镍钛合金材质和板簧结构,同时具备耐久性和弹性,从而可维持椎间盘高度。
第三,给上述融合器的骨架赋予形状记忆特性,当插入到椎间时,挤压融合器而使高度最小化,以便在患者脊椎的狭窄空间内容易地将融合器插入椎间,手术后,以椎间盘间隔,还原为融合器的高度,由此可充分确保椎间间隔,从而可消除脊椎神经压迫。尤其是,由于可根据融合器骨架的形状记忆特性使融合器自然定位,因此可消除对于融合器的位置异常(mal-positioning)的担忧。
第四,根据骨架自身的弹性运动,有机地限制椎间运动,由此可维持脊柱矢状面平衡。
第五,将椎间融合器的使用目的,从单纯的融合用融合器转换成适合于生物体的功能性融合器,由此可获得更佳的临床结果。
如上所述,赋予弹性的本发明的椎间融合器,通过上述效果可代替正常椎间盘的作用。
附图说明
图1及图2是根据现有技术的人造椎间盘的结构图;
图3是示出本发明的第一实施列结构的具有柔韧性的椎间融合器的截面图;
图4是图3的变形例示图;
图5是示出本发明的第二实施列结构的具有柔韧性的椎间融合器的截面图;
图6是图5的变形例示图;
图7是示出本发明的第三实施列结构的具有柔韧性的椎间融合器的正截面图。
标号说明
2:骨架 4:突起
12:第一弹性部 14:第二弹性部
16:第三弹性部
具体实施方式
通过结合附图详细说明本发明,使目的、特征及优点更加明确。下面,参照附图详细说明最佳实施列。
根据本发明的具有柔韧性的椎间融合器,缓解施加到脊椎的冲击并充分确保椎间盘间隔,以便控制椎间运动而代替正常椎间盘的作用。
图3是示出本发明的第一实施列结构的具有柔韧性的椎间融合器的截面图,图4是图3的变形例示图。
本发明的第一至第三实施列中提出的结构,可适用于腰椎(lumbar)及颈椎(cervical vertebrae)。
如图所示,根据第一实施列的融合器,包括:椭圆形的骨架2,具有空心的中空截面,并发挥自身的固有弹性;多个突起4,形成在骨架2的上下部外表面,与椎体紧密融合。上述突起4通过刻纹(knurling)加工,以锯齿形态形成在骨架2的上表面及下表面。
作为优选结构,上述骨架2,包括:第一弹性部12,根据内部空间,以上下方向缓冲;第二弹性部14,以从第一弹性部12的一侧面朝向中空部内侧凹进的方式形成,与第一弹性部12一起提供缓冲力。并且,将从第一弹性部12连接到第二弹性部14的区间的一定部分厚度,加工成比第二弹性部14的厚度厚,由此防止第二弹性部14的缓冲力降低,并增大耐久性。
上述骨架2的第一及第二弹性部12、14,实质上由具有U字形的闭合截面的板簧结构构成,因此根据第一弹性部12的内部空间和第二弹性部14的U字形空间,缓解向脊椎的上下方向作用的负载。
上述骨架2,根据板簧结构,发挥强的支撑力的同时上述骨架2的缓冲效果根据沃尔夫定律(Wolff’s Law),在脊椎的终板和融合器表面之间的侧,发挥良好的稳定性(或融合特性)。
并且,骨架2根据内部空间,以上下方向发挥缓冲力,由此即使没有负载施加到脊椎时产生的应力遮断效应(stress shielding effect),也形成生理学上良好的负载传达(或分配)模式,因此上述骨架2缓解患者因直立行走时的动态运动而沿脊椎的垂直方向施加的压迫所产生的负载,即从上侧脊椎向下侧脊椎侧施加的压迫(stress)所产生的负载,由此,代替正常椎间盘的作用。
尤其是,当使用以往存在问题的由钛合金材质(合金记号:Ti6Al4V)或合成树脂材料Peek(Polyetheretherketone)形成的模块融合器时,手术后,会出现塌陷在椎体内的现象,但是,根据本发明的骨架2的结构,通过冲击缓解机制,防止融合器塌陷在椎体内的现象。
根据本发明的第一实施列的变形例,如图4所示,在骨架2的第一弹性部12另一侧面可形成与第二弹性部14对称的形状,即,弯曲形成从第一弹性部12的另一侧面向内侧凹进的U字形的第三弹性部16,上述变形例,通过第一弹性部12的缓冲,第一次缓解以垂直方向施加到骨架2的负载,并通过第二及第三弹性部14、16的缓冲,第二次缓解该负载。
上述骨架2,通过挖出环棒的金属材料的内部,加工成厚度为1.5mm的中空椭圆盘,使得上下方向弹性间隔范围设定为1-2mm左右,并且,上述骨架2,优选具有24mm的长度、12mm的高度、10mm的宽度,以便插入到椎间。
具有上述结构的骨架2,由于自身具备如板簧作用的固有弹力,因此,插入到发生退变性脊椎病的部位或发生椎体不稳定的部位内,融合椎间,并执行适合于生物体的功能。尤其是,有弹性地缓冲而缓解向椎体的上下侧施加的冲击,以便限制椎间运动。
本发明的实施列中,上述骨架2,可由选自钛或镍钛合金(Ni-Ti)合金中的一个材质形成,尤其是,上述骨架2,可由具有随着温度的变化而结晶结构发生改变的形状记忆特性(shape memory)的结构构成。
尤其是,上述骨架2,具有在4℃左右的低温下弹性间隔变窄而在低于人体体温的28℃左右的温度下恢复到原位置的形状记忆特性。
利用上述骨架2的材质特性,在手术过程中,容易地将融合器插入到椎间。即,手术过程中,在低温(约4℃)下浸渍骨架2,使上下间隔变窄,此时,整个融合器的高度会变低而可容易地插入到椎间,手术之后,因体温骨架2的高度恢复而使椎间间隔维持与正常椎间盘间隔相应的间隔。骨架2的第一弹性部12及第二弹性部14的弹性操作,缓解椎间自由运动时施加到脊椎的冲击,并限制椎间运动,由此维持脊柱矢状面平衡。尤其是,上述骨架2,重建类似于正常椎间盘的负载传达(或分配)模式,由此作为骨代用品(bone substitutes),即使没有体积大的前方支撑物(anterior support)的协助,也能发挥良好的前方稳定性(anterior stability),并可防止基于反常的负载传达模式的后方动态固定(posterior dynamic stabilization)的失败。
下面,参照图5及图6,对本发明的第二实施列进行说明。
图5是示出第二实施列结构的具有柔韧性的椎间融合器的截面图,图6是图5的变形例示图。本实施列采用的材质及结构,与第一实施列的材质及结构相同,除了上述骨架2的第一及第二弹性部22、24实质上具有W字形闭合截面之外,其它结构与第一实施列相同。
尤其是,如图6所示,在上述骨架2的第一弹性部22的另一侧面可形成与第二弹性部24对称的W字形的第四弹性部26。
其次,图7是示出第三实施列结构的具有柔韧性的椎间融合器的正截面图。
如图所示,本发明的第三实施列的结构,包括:骨架32,形成为空心的中空截面的椭圆盘,形成有一侧开放的形状的开放部32a,并发挥自身的固有弹性;U字形夹板34,通过上述骨架32的开放部32a插入到中空部内表面,与骨架的缓冲联动而缓冲;锯齿形状的多个突起36,形成在骨架32的上下部外表面,与椎体紧密融合。
上述第三实施列的结构,通过施加于骨架32的上表面的冲击负载,使骨架32缓冲的同时第一次缓解冲击,并与此联动,使夹板34在骨架32的开放部32a间隔内缓冲的同时第二次缓解该负载。
上述第三实施列中,上述骨架32和夹板34中的一个,由具有形状记忆特性的钛合金或镍钛合金形成,而另一个由钛合金形成。
以上所述的本发明,不限于上述的优选实施例及附图,本领域的普通技术人员将理解,在未背离本发明的范围和精神的情况下,各种替换、改造及修改是允许的。
Claims (12)
1.一种具有柔韧性的椎间融合器,其特征在于,包括发挥自身固有弹性的骨架,所述骨架形成具有空心的中空部的闭合截面,并缓解患者因直立行走时的动态运动而沿脊椎的垂直方向施加的压迫所产生的负载,以便代替正常椎间盘的作用。
2.如权利要求1所述的具有柔韧性的椎间融合器,其特征在于,
所述骨架,包括:
第一弹性部,其通过内部空间而沿上下方向进行缓冲;以及
第二弹性部,其以从上述第一弹性部的一侧面朝向中空部内侧凹进的方式形成,并与第一弹性部一起提供缓冲力。
3.如权利要求2所述的具有柔韧性的椎间融合器,其特征在于,
所述第一及第二弹性部实质上由具有U字形的闭合截面的椭圆形的板簧构成。
4.如权利要求2所述的具有柔韧性的椎间融合器,其特征在于,
所述第一及第二弹性部实质上由具有W字形的闭合截面的椭圆形的板簧构成。
5.如权利要求3所述的具有柔韧性的椎间融合器,其特征在于,
还包括第三弹性部,该第三弹性部形成在上述第一弹性部的另一侧面,并具有与第二弹性部对称的形状。
6.如权利要求4所述的具有柔韧性的椎间融合器,其特征在于,
还包括第四弹性部,该第四弹性部形成在上述第一弹性部的另一侧面,并具有与第二弹性部对称的形状。
7.如权利要求1或2所述的具有柔韧性的椎间融合器,其特征在于,
所述骨架由选自钛合金或镍钛合金中的一种材质形成。
8.如权利要求7所述的具有柔韧性的椎间融合器,其特征在于,
所述骨架的第一及第一弹性部具有形状记忆特性。
9.如权利要求2所述的具有柔韧性的椎间融合器,其特征在于,
将从第一弹性部连接到第二弹性部的区间的一定部分厚度,加工成比第二弹性部的厚度厚。
10.如权利要求1至6中任一项所述的具有柔韧性的椎间融合器,其特征在于,
还包括锯齿形状的多个突起,它们形成在所述椎间融合器的上板的上部表面及下板的底部表面上,以便与椎体紧密融合。
11.一种具有柔韧性的椎间融合器,其特征在于,包括:
骨架,其由空心的中空截面的椭圆盘形成,且形成有一侧开放的形状的开放部,并发挥自身的固有弹性;以及
夹板,其通过所述骨架的开放部被插入到中空部内表面,并与所述骨架的缓冲连动地进行缓冲。
12.如权利要求11所述的具有柔韧性的椎间融合器,其特征在于,
所述骨架和夹板中的任一个由具有形状记忆特性的钛合金或镍钛合金形成,而另一个由钛合金形成。
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