CN1128944A - 插入脊椎植入物的设备与方法 - Google Patents
插入脊椎植入物的设备与方法 Download PDFInfo
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- CN1128944A CN1128944A CN94193049A CN94193049A CN1128944A CN 1128944 A CN1128944 A CN 1128944A CN 94193049 A CN94193049 A CN 94193049A CN 94193049 A CN94193049 A CN 94193049A CN 1128944 A CN1128944 A CN 1128944A
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- vertebra
- implant
- pipe fitting
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Abstract
一种插入脊椎植入物的设备与方法,其中首先是岔开脊骨间空隙,然后将一个在一端有齿的空心套驱入与椎盘空隙相邻的脊骨内。再用一钻孔器通过此空心套取出椎盘与骨料为容纳下此脊椎植入物作准备,此脊椎植入物此时即通过此空心套插入。
Description
与本申请有关的专利申请
本申请是1988年6月13日提交的美国专利申请系列号07/205,935的部分继续申请,该部分继续申请乃是1991年5月14日授权的美国专利5,015,247号的一个分案申请,这两项申请都已综合并入本申请中作为参考。
本发明的背景技术
1.本发明的领域
本发明涉及到拟置入到在除去损伤的椎盘后余留下的椎间空隙内的人工熔融植入物,具体地涉及到用于插入这种植入物的设备与方法。
2.先有技术的说明
为了能长期地稳定受伤的脊椎段,可以采用一种融合技术(通过加入连续式的骨桥,将两根或多根骨结合到一起)。为这一领域的技术人员所熟知的此种技术是,在椎盘经部分切除并将骨置放到原先为此椎盘材料所占据的空间(相邻的脊骨之间)内进行融合,用以恢复较正常的空间关系,并同时提供稳定性;在短时间内通过机械方式支承,而在长时期内则借助从脊骨到脊骨使骨作永久性的交联。为了能在椎盘空间内发生融合,必须这样准备好待熔接的脊骨,即必须将已变硬的外侧骨板(端板)穿透或钻孔,以使插入的骨的移植物能同有较多血管的网状(海绵质)骨直接接触,由此通过在相对的两个脊骨表面上使骨生成并愈合其移植物,来使这两个表面成为连续的骨段,进而达到治愈上述感生出的但是属于受控制的“破裂”。
本发明的目的在于提供一种植入物,以及为将这种植入物插入到除去椎盘材料后所余留的椎间空隙内,同时为永久性地消除在此位置上的各种移动而提供的设备与方法。为此,是把本发明的装置安装于椎盘间的空隙内,用以刚性地和自稳定地抵抗移位,使相邻的椎骨稳定以消除局部运动,并能从本质上参与脊骨至脊骨的融合,而得以保证这种结果的持久性。
目前,在除支损伤的椎盘后所余下的空隙内要么置入骨质件要么使其空置。使上述空隙空置会使该空隙塌缩,而这种塌缩有可能伤及神经;或者此空隙有可能为伤疤组织充填,并最终导致重新成疝。应用骨质件来充填上述空隙并非最佳方法,原因在于由病人身上取得的骨质件还需另作外科手术,从而限制了它的最有效的使用形式,要是从其它方面来获取这种骨质件,则会缺乏有活力的骨细胞,会招致显著的感染风险,还由于它通常是从事故的牺牲者身上来获取的,其供应源也会受到限制。此外,不论骨的来源如何,从结构上看它只可能是大致上合乎要求,而缺乏一种装置使其本身能防止移位而稳定,或能稳定相邻的脊骨。
a.先有技术的植入物
为开发出合格的椎盘假体(人造椎盘)已进行过众多种尝试。这类设计出的装置是打算用来置换受损的椎盘,寻求恢复相应空隙的高度,同时恢复这一脊椎骨节的正常活动。但是这类装置尚没有为医疗部门所认可的。这类假体或人造椎盘的替换物,它们所追求的目的在于保持脊椎活动,因而有别于本发明,其中包括:
授予STUBSTAD的美国专利第3,867,728号,描述了一种挠性的椎盘植入物。
授予KUNTZ的美国专利第4,349,921号,描述了这样一种挠性的椎盘替换物,其上面带有锉刀状的突起以防止此种器械错位。
授予PATIL的美国专利第4,309,777号描述了一种保持活动的植入物,它带有齿状的外表面以制止错位,同时包括有一系列弹簧将脊骨相互推开。
授予FRONING的美国专利第3,875,595号,描述了一种保持活动的叶片状的椎盘替换物,它带有两个对峙的柱状突起物来阻止错位。
授予FASSIO的法国专利第2,372,622号,描述了一种保持活动的植入物,它包括一对互补的凸面与凹面。
总之,上述这些装置与本发明的类似之处只是它们也是在除掉受损伤的椎盘后置放到椎间空隙之内。在试图保持脊椎活动方面,它们则截然与目的在于使此种脊椎段上永久性地消除所有活动的本发明不同。
第二个相关的先有技术领域则包括着用来更换实质上是所有除去的脊骨的装置。这种除去一般由于广泛性的脊骨损坏或是肿瘤而成为必须的,但与治疗椎盘疾病无关。虽然本发明的装置是要置放到椎盘空隙之内,但其它的脊骨装置则是不能置放到这一椎盘空隙之中的,这是因为在已取出至少一个脊骨之后已不再留有“椎盘空隙”。此外,这些其它的装置是限于用作临时性的结构件而由机械方式来更换除去的脊骨(不是除去的椎盘),并非从本质上提供成骨的材料来实现交叉形式的脊骨融合,于是,与提供成骨作用的本发明的不同,利用上述相关技术中的这类装置就必须伴随另外的外科手术,这包括采用常规技术的骨融合方法。这样一组包含着由脊骨撑条组成的而并非椎盘更换物的装置包括在下述一些专利中:
授予WU的美国专利第4,553,273号,描述了一种紧线器式的脊椎撑条。
授予REZAIAN的美国专利第4,401,112号,描述了一种这样一种紧线器式的脊椎撑条,它另外包括有跨接着空缺脊椎体的稳定用钩环。
授予KAPP的美国专利第4,554,914号,描述了一种大型的可分岔的尖钉,它借助一个螺旋机构延长,以跨接除去整个脊椎所留下的空隙,同时用作丙烯酸粘合剂的固接件,然后用于置换空缺的脊骨。
授予OGILVIE的美国专利第4,636,217号,描述了一种脊椎撑条机构,它能在至少有一脊椎骨取出之后植入,同时它包括有一种机构可使螺栓旋合到己除去的脊椎骨之上和之下的脊椎骨之上。
总之,此第二类装置与本发明的不同处在于,前者是一些脊椎更换件撑条,它们在本质上不参与骨的融合,只能插入整个脊椎骨已然从前方入口处撤除的有限区域内,而不是设计周来或准备用来治疗椎盘疾病。
与本发明有关的先有技术的第三个领域包括着所有设计用于脊椎的表面之一上的装置。这类装置包括各种类型的通过由钩以及丝状件与螺旋接附上的板件、撑条与杆,这类装置与本发明显著不同之处在于,它们并不插入到椎盘的空隙内,而且在本质上也不为前述融合提供成骨材料。
于是,在要求使脊椎骨作永久性不活动的场合,还需要另作外科手术,这包括用传统方法进行的脊骨融合或需要使用辅助性的甲基丙烯酸甲酯粘合剂。适用于脊椎而不是椎盘空隙内的这类装置包括下述专利中所述及的内容。
授予STEPHENS的美国专利描述了一种U形金属棒,它借助丝状件接附于脊椎的背侧部件上,以在大部分脊椎段上稳定住脊椎。
授予KNOWLES的美国专利第2,677,369号描述了一种金属柱装置,它将沿着只靠自身形状保持就位的腰脊设于前侧,并通过将脊椎锁定在其全弯曲状态下而在脊柱后侧的横向上将压力锁定,由此来将最大重量向后移到病人本身的椎盘上。
其它的装置不过是利用杆状件(例如Harrington,Luque,Contrel-Dubosset,zielke)丝状件或缆件(Dwyer),板件与螺栓(Steffee)或撑条(Dunn,Knowles)等的变型。
总之,上述装置没有一种是设计用于,也不能用于椎盘间隙内。此外,这类装置不是去更换受损的椎盘,而且从本质上也不参与产生骨的融合作用。
需要考虑的与先有技术有关的另一领域是这样一类装置,它们设计成在除去受损的椎盘后放入脊骨间的间隙内,并用来在此位置上进一步消除活动。
这种装置见于授予BAGBY的美国专利第4,501,269号,其中描述了一种可植入的装置和受到限制的器械。它所用到的方法如下:沿横向钻一个穿过脊椎关节的孔,然后将一个直径较此孔大的空心金属架嵌入此孔,再以钻孔时产生出的骨屑充填此空心金属架。
尽管本发明(装置、器械与方法)与BAGBY的发明在表面上有某些类似,但这种相似性是极其微小的,而差别则是成倍成倍地并且极为显著。这些差别包括如下:
1.安全性—本发明提供了一种受到完全保护的器械系统,使得所有邻接的重要结构(例如大的血管,神经结构)都受到绝对保护。本发明的这种装置也不可能被过度钻穿。这种过度的钻穿例如在颈椎骨处就可能导致病人全瘫,甚至死亡。在胸椎,这会造成全瘫。在腰椎,这会造成瘫痪或是致命的主动脉、腔静脉或髂管血管的穿孔。
本发明装置能够无损伤地旋合就位,与此截然相反,BAGBY的装置则是靠敲打就位的。BAGBY谈到,他所发明的植入物在尺寸上显著地大于所钻的孔因而必须敲入。这是极其危险的,而敲打则又是直接发生在不稳而极易受冲击损伤的脊髓处。此外,例如在腰椎处,在插入本发明装置时是可以避开脊髓与神经的,而BAGBY的装置则总是直接对向脊髓敲打的。
还由于BAGBY的装置是在很大阻力下敲入一平滑的孔中,而缺乏任何特殊设计的特点来固定它,这种装置就极有可能被强制推出,而给病人带来极大的危险,导致临床医疗事故。本发明装置则与此相反,它可以牢靠地旋合就位,同时具有高度专门化的锁紧螺纹,使之不可能发生偶然性错位。由于脊髓、脊椎神经与血管分布在附近,因而用BAGBY的装置时可能发生的植入物的任何错位或许会带来灾难性后果。
2.广泛的适用性—BAGBY的装置只能从脊柱的前方插入,但本发明的装置则与此不同,其可以用在颈椎、胸椎与腰椎处,并且可以在腰椎处从后方(后侧)插入。这对于把这类装置用于治疗椎盘疾病具有重大意义,而且可能是99%以上的所有用来处置椎盘疾病的手术都是从也易于采用本发明装置的上述后侧位置进行,而按照BAGBY的说明,则是不可能的。
3.椎盘的取出—BAGBY的发明要求在钻孔步骤之前完全取出椎盘,而本发明则消除了这种麻烦的单独取出椎盘的过程,可以由一道工序来取出椎盘并准备好椎端板。
4.需用的时间短—本发明与BAGBY的发明相比,由于在开始融合作业之前不需耗费劳力来取出椎盘,故能节省时间。此外,本发明中的过程是通过一种受保护的器械系统来进行,于是在经常性地放置和更换各种软组织牵开器的整个过程中不会耗费时间。
5.植入物的稳定性—植入物的移位可能是这类装置事故(失败的临床外科结果)的主要原因,有可能造成病人瘫痪,甚至死亡。正如上面论及的,BAGBY的装置缺乏任何用来实现稳定性的专用器具,还由于它是靠反抗阻力敲入来实现脊椎的岔开,就易因两个脊骨的岔开倾向导致强烈的移位,在返回其原位时将植入的装置挤出。但本发明则是旋合就位的。由于在脊椎之间不存在旋松退扣的力,单纯的压缩力是不能使植入物移位的。这样的植入物基于它的设计在本质上就是稳定的。此外,本发明的螺纹是具有很高的特殊性的,亦即这种螺纹是周期性地断开的,使得所形成的各个接头的尾端是钝头和扭弯了的,得以阻止意外旋松。要除去带有这种“锁定螺纹”的植入物时,需要采用这种装置内的一种特殊取去器。与BAGBY的装置完全不同,本发明的装置的稳定性可以获得进一步地提高,这是由于存在有一种“骨质向内生长”组织形成表面,它既可以增加有关配合的摩擦力,同时还允许脊椎骨直接长入植入物本身的外皮内。
6.脊骨的稳定性—本发明的装置不仅是自稳定的,它还至少以三种方式给相邻的脊骨提供稳定性,而这是BAGBY的装置所不能做到的。首先,BAGBY的装置是横跨中心的关节设置,留下两个脊骨在这样一个圆筒形轴上前后摆动,极类似于跷跷板所用的在一筒上的板。
其次,由于BAGBY装置缺乏任何抵抗滑动的专门设计特点,它在实际上起到允许这些脊骨相对于此装置同时相互相对平移的第三体的作用。
第三,任何装置只有在它被保持成合适定位时才能提供稳定性。本发明的装置从本质上来说就是稳定的,因而它可使两相邻的脊骨稳定,而这是BAGBY的装置所不能做到的,待治疗的脊骨的不稳定性就可能造成BAGBY的植入物移位,进而导致脊骨的稳定性进一步降低。
7.空隙的塌陷—虽然本发明的和BAGBY的装置都能制造成可经受空隙内的压缩力,但随着植入物进入到脊椎骨内,这样的空隙在自上而下的体重作用下是有可能塌陷的。这同每单位面积上的载荷有关,而本发明则至少在下述四个方面优于BAGBY的装置。
首先,本发明提供了大得多的表面积来分配这种载荷。其次,虽然BAGBY的装置是放在中央,但本发明的装置则从两侧朝向边缘设置在脊骨显露出较大的表面区和更结实的部位处。第三,本发明支承载荷实现一种工字梁效应,而BAGBY的植入物则与此不同。第四,压力不仅仅使得植入物邻近的脊骨塌缩,而由于在植入物反抗脊骨压力下的运动还会便脊骨侵蚀。正如在上面第6项中论述到的,本发明的装置则能独立地对此种运动具有高度的稳定性,还能消除侵蚀的可能性与空隙的塌陷。
8.骨质向内生长的表面结构—本发明采用了一种周知的和常规的表面处理技术,以诱发骨质从脊椎骨直接长入植入物本身的外层材料内。BAGBY的装置则不具备相似的特点。(在装配线上装配时,我们可能需要列出这些骨质生产因素的例子)。
9.融合物质—BAGBY的发明要求除下椎盘然后在相邻脊骨之间钻孔,然后将产生的骨屑回填于此装置内。本发明则从髂骨的颈脊中取出产生骨髓的纯骨芯,然后采用特殊的加压将这种成骨材料的极其致密的压缩芯料强制注入此种植入物装置中,直至这种材料本身最后从此植入物的每个胞腔中挤出时为止。
10.实现融合的概率—在脊椎内的融合率周知直接关联到暴露的血管骨着床面积、可资利用的融合物质的质量与数量、以及由所有其它半恒定的因素所取得的稳定化程度。于是可以认定,本发明的融合率会优于BAGBY的装置的,这是因为本发明具有最佳的植入物稳定性(第5项),最佳的脊椎稳定性(第6项),骨质内生长的表面处理(第8项),优良的融合物质(第9项)以及较大的暴露的脊屑表面积(第7项)。
与本发明可能有关的因而将予以考虑的最后一个先有技术的领域关系到“骨质内生长”,它们表现为专利形式,或是描述生产材料的方法或是涉及到材料本身,或是涉及到获取这种材料的装置。这样一些专利包括以下各个美国专利号:
第4,636,526号(DORMAN),第4,634,720号(DORMAN),第4,542,539号(ROWE),第4,405,319号(CONSENTINO),第4,539,152号(SMALL),第4,168,326号(BROEMER),第4,535,485号(ASHMAN),第3,987,499号(SCHARBACH),第3,605,123号(HAHN),第4,655,777号(DUNN),第4,645,503号(LIN),第4,547,390号(ASHMAN),第4,608,052(VAN KAMPEN),第4,698,375号(DORMAN),第4,661,536号(DORMAN),第3,952,334号(BOKROS),第3,905,047号(LONG),第4,693,721号(DUCHEYNE),第4,070,514(ENTHERLY)。
但是,本发明的植入物虽然用到了骨质内生长工艺,但它采用的则是常规的技术。
b.先有技术的装置与方法
以下是插入脊椎植入物的先有技术的设备与方法。
1956年,Ralph Cloward开发了一种方法与以后为他描述为用来制备颈椎的前向外姿(前胸)装置,这种装置然后将此颈椎加以融合,Cloward是用外科手术除去待横向融合的椎盘,然后将一个带有大型踏板与尖状件的刚性钻模向下放置到一定位模上,并将此尖状件嵌入相邻的脊骨内以保持这种定位对正,以便对此椎盘空隙邻近的脊骨进行扩孔。当此大的踏板落定到脊椎之前时,它就可以用作为控制钻孔深度的固定参考点。扩孔的结果从相对的脊椎表面上在每一侧留下一个相对交会的弧形。然后便完全撤出此仅为钻孔准备而设置的管状钻摸。此时将一个直径显著大于所形成之孔的柱形骨榫敲打入已业钻成的孔中。Cloward的器械化方法设计用来且限于用在前胸部位与颈椎区中。上述的孔处于中线位置上,这就排除了将此种方法用在脊髓所在地的后方。
由于Cloward方法中所要插入的骨移植物必须在直径上大于所钻出的孔,此种移植物就不能通过钻模插入。这种就要除去钻模,而使植入物在插入阶段完全处于无保护状态下。这样,Cloward的方法和装置完全不适用于后方应用。
此外,由于不能由所述装置为精细的神经中枢提供连续性的保护,以及在处理过程中产生有骨与软骨的骨屑,也使得Cloward的方法不适宜用于后方应用。还有,Cloward所描述的钻模是不能放在脊椎通道的后方的,这是由于前述踏板可能会伤及神经。通过完全除去踏板来改进Cloward的钻模,则由于缺乏稳定性而仍然导致装置完全不能工作,并且使得落座的深度成为不可控制的。
Wilterberger(Wilterberger,B.R,Abbott,K.H.,“应用于腰椎盘外科中的椎脊椎间的融合技术”骨及关节外科技术杂志”“Dowel Intervertebral Fusion as Used in Lumbar Disc Surgery”,The Journal of Bone and Joint Surgery 39A卷,第234-299页,1957年)描述了从后方无保护地钻入神经根部间的腰椎内并跨接于椎盘空隙之间的一个孔,然后将一垛钮扣状的榫插入此空隙内。虽然Wilterberger采用了Cloward有关圆形钻孔与榫融合的思想,并将其从后方通道用于腰椎,但他没能提出一种改进了的方法,也未将装置改进到能使相应的操作过程充分的安全,从而此方法被迅速地遗忘掉。
Crock(Crock,H.V.,“前向腰椎体内融合-在外科技术上的使用与说明指导”医疗矫形术“Fusion-Indications for its Useand Notes on Srugical Technique”,Clinical Orthopedics,第165卷,第157-163页,1981年)描述了他的用于腰椎前方体内融合的方法与装置,其中他从前方至后方,横跨椎盘空隙,基本上是无保护的钻有两个并列的孔,然后敲打入两个制备好的较这两个孔要大的至少有一部分为圆柱形的移植物。
对先有技术的综述表明,在利用钻孔制备端板所进行的体内脊椎融合的性能方面,有关的方法与装置中是存在许多的显著的缺陷的。
在腰椎中并从后方所进行的绝大部分脊椎外科手术而论,对先有技术的综述表明,一般地说就脊椎而论,而特别是就从后方通达腰椎而论,是有许多缺陷的。这些缺陷包括:
1.在整个过程中,具体是在钻孔之前直到放入移植物之后,未能保护周围的组织;
2.在上述过程中不能接纳所产生的骨或软骨的骨屑;
3.不能使圆筒形的钻孔与骨移植物作最佳接触,它们之间直径的不一致导致配合不适;
4.无法在钻孔前确定出最佳钻孔尺寸;
5.无法在钻孔前确定出关节面分离的最佳量;
6.由于不能使骨节面的分离量最佳,故不能在相邻脊骨间恢复正常的空间关系;
7.不能在脊椎的渠道(在神经根与铝钢带之间)内建立充分的工作空间来保证上述过程安全;
8.在钻模上缺乏踏板,而这是从后方来说为达到紧配合所必须的,这样就不能保证能平行于脊椎端板钻孔;
9.不能保证从相对的脊椎表面上除去相等数量的脊屑;以及
10.不能在脊椎渠道内为钻出两个孔确定出合适的并列定位关系。
本发明的概要
本发明包括一系列人造植入物,目的是切除受伤的椎盘之后,用于横跨椎间的空间上,参与并直接导致椎骨融合。这种植入物从结构上说是能够承受载荷的,较骨更结实,能经受住脊椎间隙内所产生的很大的力。本发明的这种装置具有很多大尺寸的空腔与孔口,它们能够盛载融合助长材料例如自生骨科,用来从料性上影响相邻的脊骨,使其对植入物作骨结合并相互结合。植入物的外皮可以是有结构的表面,或是用众多的周知工艺中的任何一种予以处理,以获得一种“骨内生长表面”来进一步提供植入物的稳定性而有利于融合。
本发明的装置经构造和设计成能促进其自身在脊椎间隙内的稳定性和抵抗移位,此外能稳定相邻的脊椎段。
本发明的用来预先对脊椎处理以便插入植入物的设备与方法,能够快速和安全地取下椎盘,处理好脊骨,进行融合,并使脊椎段在内部稳定化。
本发明涉及一种采用新颖的装置进行体内脊椎融合的方法,在此,于有关过程中的钻孔部分之前设置一保护管件,并使其保持到移植物已完全就位好为止。
在优选实施例中,采用两个分离件将两个相邻脊骨分离至一最佳距离。将一个在一端有齿的外套驱入在一侧的相邻脊骨内,当分离件取出时将脊骨保持就位,在上述外套内引入一减少直径的空心内套,将一带有钻头定程停止器的钻头通过空心内套来钻出一个达到所需深度的孔。同时将一植入物插入此孔内。对上述椎盘的另一侧可重复此方法。
总之,本发明的装置与方法能通过简单的外科手术而集预处理、融合与体内脊椎固定于一体。
设备与方法的讨论
本发明的设备与方法具有以下优点:
1.本发明由于能给周围的组织提供保护是较为安全的。用一个外套将所有精细的软组织结构、神经、血管与器官置于各种锐利的外科器械与植入物之外。此外,对手持的牵开器作了改进,使得它所占据的面积尽可能地少,避免了与手动抽回有关的伸展操作,为抽回提供了准备,并能在所有方向上沿周边且同时地对周围组织进行屏蔽,这样就能独一无二地获得光滑的弧形表面。
2.本发明由于对装置或植入物的过度穿透的危险提供了保护而更为安全;
3.本发明由于在相应过程中使手术部位与伤口不受产生出的骨屑影响而更为完全;
4.本发明由于其方法对软组织直接提供了绝对的保护,同时对过度穿透的间接伤害提供了绝对的保护而更为安全。这样就能安全地使用更高效和实用的动力装置。
5.本发明在整个操作过程中使待融合的脊骨保持为刚性的。
6.本发明的整个操作过程中使待融合的脊骨保持准直。
7.本发明在整个操作过程中使待融合的脊骨保持成分开状态。
8.本发明确保了所有通过外套引入的装置都是同轴的,并且均衡取中心地通过椎盘空隙且与端板平行。
9.本发明通过反抗导致空隙可能消失的高压缩力而能促进植入物的插入,这种压缩力如果不加以制止将会阻碍植入物的引入与推进,并且有可能使其脱离。
10.本发明由于在整个脊椎上来实现上述过程中变得安全,也就使此过程的涉及范围与用途得以延伸,类似地,对于体内脊椎植入物本身也是如此。
11.本发明提高了应用特定尺寸植入物的能力。
12.在本发明中,所有穿透装置的端部都是钝面的。
13.在本发明中,所有装置都终止于一预定深度以免过度穿透。
14.在本发明中,上述外套的设计符合具体手术现场的空间限制。
15.在本发明中一第二套或内套的设计和使用允许外套的内径和钻头的外径之间在尺寸上有差异。这种差异需适应生成的岔开以及植入物的周缘螺纹深度的总和。
16.在本发明中,用一种带有中心轴凹槽的专门设计的钻头可以安全地收集起钻孔产物,然后作为一个单元来除下钻头与内套而可以无干扰地除下外套。
17.在本发明中,用一种特别设计的环钻来除去骨芯,此种环钻的直径小于植入物空腔的内径,但具有较大的长度。
18.在本发明中,采用了一种专门设计的加压器,用来强制地将长的自生骨芯压到并通入植入物中,使之能通过植入物本身挤出。
19.在本发明中,采用了一种专门设计的驱动抽取器,可用来插入或取出植入物,而此种抽取器本身除非操作者慎重作出脱开的决定时是不会脱离开植入物的。
20.在本发明中,采用预岔开的措施能加大工作空间。
21.本发明的岔开器是自定向的,能起到探向器的作用。
22.本发明的岔开器在相对的脊骨面之间是自对中的,为维后的取出骨的操作起到一定的柱作用。
23.本发明的预岔开措施保证了能从相邻的脊骨表面上均匀地除骨。
24.本发明的预岔开措施保证了钻出的孔与装置精确的一致。
25.本发明的预岔开措施保证了能平行于脊骨端板钻孔。
26.本发明的预岔开措施得以在钻孔前确定最佳的岔开状态。
27.本发明的预岔开措施得以在钻孔前核实正确的假体尺寸。
28.本发明的预岔开措施由于在整个空隙上释除了将阻止植入的压力荷载而有助于植入物的插入。
29.本发明的预岔开措施减小了插入过程中使骨脱落的可能性。
30.本发明的预岔开措施得以在最终钻成孔之前,为所需要的并行定位,分间距与保持平行度作好准备。
31.本发明的预岔开措施能够在整个手术过程中,使与椎盘空隙相对的脊骨可靠地稳定。
32.本发明的预岔开措施,由于相对脊骨的压缩荷载得以制止,使得植入物本身在插入时不需将脊骨驱离开,从而能较易地将植入物插入。
33.本发明的预岔开措施由于能将植入物更充分地用于其预定目的并充分利用其整个直径,从而能更有效地插入植入物,而要是不去利用这种预岔开的措施及维持这种预岔开的能力,则此植入物的前端就会有显著一部分必将成为用来相对脊骨分开的目的。
34.本发明允许使用带有效尖锐螺纹或表面突起物的植入物,因为这不会危及周围组织。
35.本发明允许在将植入物提供给外科医师时已完全预加载,或让外科医师在手术时由他所选择的材料作预加载。
36.本发明可让脊椎植入物在脊椎通道之外并在植入之前加载。
本发明的目的
本发明的一个目的在于提供一种改进的方法,以对脊椎进行切剖、融合和内固位,特别是上述这三者可在同时作为一单一过程进行。
本发明的第二个目的在于提供一种改进的方法,以对脊椎进行切剖、融合和内固位,它与以前方法相比,更快也更安全。
本发明的第三个目的在于提供一种改进的方法,以对脊椎进行切剖、融合和内固位,以提供经改进的外科手术用脊椎植入物。
本发明的第四个目的在于提供一种改进的方法,以对脊椎进行切剖、融合和内固位,此种方法给相应的外科手术提供了一种经改进的系统,便于综合进行脊椎的切剖、融合和内固位。
本发明的第五个目的在于对脊椎的治疗过程提供一种进行切剖、融合与内固位的经改进的方法。
本发明的第六个目的在于为脊椎的体内关节固定术提供装置与方法,使之比先有技术方法更快、更安全和更有效,并且能对颈椎、胸椎与腰椎在前部和对下腰椎从后部有效地进行。
本发明的第七个目的在于提供一种装置,用来将一脊椎植入物插于相邻的脊骨之间,同时保持住它们的最佳间距、定位与准直关系。
通过阅读下面的说明和附图,将进一步理解本发明的上述目的和其它目的。
附图的简单说明
图1是本发明的插入脊椎间空隙内的长岔开器的侧视图;
图2是一个相对脊椎可变换的岔开器组件的侧视图;
图3是图2中一种高保持力的短岔开器的透视图;
图3A是图2中所示的高保持力的短岔开器的侧视图;
图3B是带有周缘面朝前的棘齿的另一短岔开器的侧视图;
图3C是图3B中所示的另一短岔开器的顶视图;
图3D是一短岔开器的另一实施例的透视图;
图3E是图3D所示的另一叉开器的顶视图;
图3F是带有滚花表面的又另一矩形化的短岔开器的侧视图;
图4是一脊椎段(两个脊骨与一中介的椎盘)的透视图,有一短岔开器放置就位,上脊骨的一部分与椎盘经切除,以在脊椎的一侧上显示出短岔开器,同时显示出将放置到对侧上的长岔开器;
图5示明位于长岔开器之上的外套的侧视图,此外套要用来接纳驱动器罩而准备就座;
图6示明长岔开器、外套与驱动器罩在外套恰当定位于两个相邻脊骨内的情形;
图7A是放置到长岔开器上的颈部外套,此长岔开器是从前部放置到椎盘空隙内;
图7B是图7A的所述的单一外套的底视图;
图7C是一双重外套的底视图;
图7D是图7C中邻区部分的放大侧视图;
图7E是用于驱动两个岔开器的双重驱动器罩的底视图;
图7F是示明图7C与图7D的双重外套,图7E中定位好的岔开器与双重驱动器罩的侧视剖面图;
图8是在长岔开器上对中且完全定位到颈椎的前部位上的图7A的外套的侧视图;
图9是岔开器拉出器具的透视图;
图10是接合到外套的端部上的长岔开器的抽出环上的近端拉出器具经切开的部分侧视图;
图10A是在长岔开器正好要抽出前与其结合的拉出器具的侧视图;
图10B是近端外套与短岔开器相对于脊骨、椎盘与神经安装就位时的后视图;
图11A是在外套内加钻孔器与内套且钻过椎骨间空隙并从相邻脊骨上切下部分柱形的弧段的侧视剖面图;
图11B是由另一种“环钻法”加工出脊骨间空隙的部分侧视图。图中示明了已安装在就位的岔开器、环钻、内套与外套;
图11C是如同图11A的侧视剖面图,但示明的是采用了另一种钻孔器构型,其中延伸的近端部分既为岔开的,也是自定心的;
图11D是用在钻孔后从脊骨上取下弧形骨段的装置的侧视图;
图12是在外科手术用丝锥的透视图;
图13是外套与完全旋入到脊骨间隙内的外科手术用丝锥的侧视图;
图14A是骨采集环钻与马达适配器的侧视图;
图14B是植入骨加载装置的透视图;
图15是上述骨加载装置作业时的部分透视图;
图16是将与脊椎植入物结合的植入物驱进器的透视图;
图17是借助已就位于外套内的驱动设备得以在脊骨间空隙内完全就位的脊椎植入物的侧视图;和
图18是表明经由后方路径将相应装置植入后的最终结果的腰椎侧视图。
附图的详细说明以及插入方法的详细说明
下面的讨论涉及经由后方通道对腰椎的应用。本发明的方法在其最简化形式中包括以下各步骤。将病人放置于脊椎手术台上,此手术台允许使待融合的椎盘空隙岔开与定向。然后作或不作部分切剖使脊骨间隙从双侧呈后向暴露状态。利用岔开器岔开椎盘空隙,同时将一空心外套配合到这些岔开器中的一个之上。此外套的端部上有齿,用以与两相邻脊骨啮合。将外套驱入脊骨内然后撤下岔开器。再将一空心内套插入上述外套内,并用一限程钻头对相对的脊骨表面加工。将此钻孔器与内筒作为一个单元撤出。必要时可对上述空隙攻螺纹。然后利用一限程插入器将制备好的脊椎植入物经外套插入。再将有关器械撤出而对脊椎的相对一侧重复上述步骤。
优选实施例的详细说明
步骤1a:进行外科手术前将适当地调节好比例的半透明植入物型板叠置到待融合的脊骨间隙的观察板上的横向与轴向图象上,用以选择最佳的植入物尺寸和确定所需的岔开程度。
步骤1b:病人最好是被放置到一既能导致岔开又能使脊骨定向的脊椎手术床上。
步骤2:在此优选实施例中,进行一种标准的双侧(部分)剖切,同时除去与上述间隙相邻的脊骨体的任何后侧凸出部分。另外,不需除去椎盘物质。在此优选实施例中,上述间隙是这样暴露的,即进行双侧的成对的半偏侧椎板切除术,并将与脊椎通道相邻的小平面关节的内部结构剖切,同时保存上部的及脊椎间的韧带。
步骤3:从第一侧开始,从中间牵开硬膜囊与在此高度上横过的神经根,然后将一长岔开器插入,使其与上述空隙相邻的后脊骨体平齐。然后将带有直径加大的工作端的长岔开器顺次地插入,直到获得最佳的岔开状态。这样的最佳岔开状态不仅能恢复上述间隙的正常高度,还能实现抵抗此空隙塌缩的一种平衡,它使脊骨体的推离受到围绕这样一个脊椎段的有力的软组织结构的抵抗,此脊椎段包括椎盘(环形纤维质)的外表、各种韧带、胶囊结构以及肌肉与其它软组织结构。这种平衡的岔开状态不仅能从空间上恢复上述间隙的高度,而且还由于此时这一空隙能进一步抵抗岔开或塌缩而能提供显著的稳定性。
在此优选实施例中,当接近所需的岔开程度时,即终止使用坚硬的长岔开器而代之以可拆卸的变换式岔开器,它带有有触觉的和/或放射图象式的那种理想岔开状态的构型。然后将可变换的岔开器拆卸,因而让短岔开器留在原位,而使超低的剖面头部位于脊椎通道底板附近并安全地避开神经结构。为了确保短岔开器能保持就位到需要将其撤下时为止,可以获得对于移位具有不等稳定程序的各种实施例的短岔开器。在此优选实施例的这一过程中,现在将注意力转到脊椎的相对侧。
步骤4:在同一脊骨间隙的相对侧,将工作端直径与业已就位的短岔开器相匹配的长岔开器插入。但要是由于这种间隙的塌缩是不对称的,为了获得最佳的稳定性,于是可以确定在此第二侧上需要有较大的岔开程度。此时将从第一侧上除去那个短的岔开器而代之以较长的长岔开器,以使此空隙平衡。
在另一实施例中,是在脊椎相对侧上重复上述过程之前,则利用长岔开器左脊椎的一侧上进行整个过程。虽然这一方法可以根据此优选实施例中所述其余步骤来执行,但最好是利用一种环钻来应用此方法,利用这种环钻可让长岔开器保持于原位,由此就能允许岔开上述间隙,而不需用借助短岔开器的第一种方法。这另一种方法要求将环钻用在长岔开器的上方来取代一扩孔钻,于是就把它称之为“环钻法”,以后将对此详加讨论。
步骤5:将短岔开器置于脊椎的第一侧,并把相匹配的长岔开器设置于脊椎的第二侧,将硬膜囊与横向神经根安全地牵开,把外套放置在长岔开器之上,并用冲击罩与被牢牢地击打到其最佳长度。然后撤除长岔开器。
步骤6:现在将内套放到外套中,然后利用钻头、端铣刀、扩孔器或环钻对上述间隙于相应侧上加工,将拟除去的滑料钻、铰或切削到任一侧上,也对任何剩余的位于中间的椎盘料作类似处理。在这种优选方法中利用了一种专门设计的端铣刀一钻孔器,并将其与内套作为一个单元撤出,从脊椎通道内安全地带走陷落在上述单元内的脊屑与椎盘屑。
步骤7:在需要时,可将一带有控制插入深度的穿透限制装置的螺纹形成丝锥插过外套。
步骤8:然后利用特别的驱动装置将加工好的植入物插入。应知这种植入物可由与骨质融合相容的物质涂覆、制造和/或加载而成。但在此优选实施例中,则是使此植入物由骨质促进与感生物料处理,但是加载则适用于参与融合的物料。
虽然天然与人造的两种物料都在本发明的范围内,但此优选实施例则是据下述方法来应用病人本身的骨料。利用一种空心的环钻从骶骼关节邻近的骼骨顶部的后上方获取骨芯。这种骨芯的外径略小于待装载的脊椎植入物的内径,但较此脊椎植入物长。利用为此目的设计的器件,可将骨芯从环钻中注入到此植入物中的中央空腔内,以在植入物内导致此种骨料过剩,而使其趋向于通过与植入物的外表面连通的孔口压出。
步骤9:利用驱动取出器装置,将制备好的植入物旋入已加工完的前述间隙同。从脊椎的旁侧取出此装置,再导向此脊椎的第一侧。用一种小型的牵开器从中间来移出硬膜囊与横向神经根,保护它们并允许观察所保持的短岔开器装置。可不必撤下短岔开器而将其再装配到其轴部上,实质上是将它重新构制成一个长岔开器。利用此时在相对一侧上起到岔开器作用的插入的植入物,就可用长岔开器将外套向下导引到它在步骤5中所述受击打的地方。
然后重复步骤6与7,在此水平上完成此过程。再按通行方式冲洗和封闭伤口。
优选方法的典型例子
通过对病人的后方、前方、侧向与轴向作影像MRI扫描,结合的对各种尺寸植入物的半透明盖层,可以精确地判断正确的植入物直径与长度,以及为使脊骨间空隙恢复到病态前(正常)高度所需正确的岔开量。然后让病人合适地定位,并通过成对的半偏侧椎板切除术进行双侧部分剖切。
在此例子中,假设通过预操作判断,确定出正确的植入物的外径为18mm而长为26mm。此外,为恢复所述间隙高度所需的岔开量约10mm。此时从中间牵开硬膜囊和横向神经根并加以保护,同时插入一长岔开器,它的筒部的外径对应于待插入的植入物的外径,即18mm,而其工作端的直径约8mm。通过直接观察,此数值略小于最佳值,此时插入一可变换的岔开器,它筒部的外径为18mm,而其工作部的直径为10mm。直接观察和/或X射线检查肯定这是一种理想的岔开器,此时拆卸此可变换的岔开器,撤下筒部与头部,将此短岔开器部分深深地嵌入留置,并以其带凸缘的平头部贴向渠道板并深达神经结构。此时可以安全地允许硬膜囊与神经根返回到其正常位置,这对于短岔开器的带凸缘部分则是显而易见的。
现在注意相对一侧。硬膜囊与神经根此时将于中间在所述第二侧牵开,同时将一个18mm直径的筒部和10mm工作部的长岔开器插入到所述间隙内,且若必要时驱动它使之与脊骨平齐,这样一种冲击使得任何还未移动的骨赘向内破裂,保证了上述筒部的肩部相对于邻近机体的后部取平靠形式。在硬膜囊与神经根仍处于安全的牵开状态时,将外套放到长岔开器之上,同时应用驱动罩与槌使其就位于最佳路径上。
在此优选实施例中,此时将长岔开器撤去而将内套插入到外套中。由于内套的目的是用来支承钻孔器和使得植入物的尺寸能增加大于钻孔器的尺寸,这样就能便植入物通过外套插入,于是内筒的外径为18mm,而内径是16.6mm。这样便可使它配合到外套内,外套的直径是18.1mm并容纳下直径为16.5mm的钻头。
钻孔之后,将钻孔器与内套作为一个单元连带其中夹裹的软骨屑与骨屑一并撤出。钻透的深度是预先设定的,且受到外套上固定的刚性柱限制。在此实例中,预备的空隙深28mm,这是预先考虑到一个26mm长的植入物埋头至少2mm。如果采用了丝锥,在将其插入时要与拟插入的植入物的以及与钻孔器的螺纹内外径相称,并控制其插入深度。此时将准备好的脊椎插入物通过下述方式植入,即利用一环钻获取后髂骨的芯料大于30mm长而直径约14.5mm。
利用骨加载装置,将上述骨芯强制送入以后将罩盖上的脊椎植入物中。将盖罩端前推,已充分加载的植入物此时将结合到插入驱动装置上,促使外套向下,并旋合到穿透深度受插入装置所限的深度处。然后从植入物上旋松拧下插入驱动装置并将其从外套上卸下。在硬膜囊与神经根牵开并处于受保护状态下时,将外套撤下。于是在这一侧上就完成了融合过程,然后如已说明的,对同一间隙的另一(第一)侧重复此过程。
其它方法
另一种极其有用的方法是“环钻法”。它的优点包括,可使其与此优选实施例相结合使用,应用一种空心的称之为环钻的管状切刀来代替此优选实施例步骤5中所用的钻孔器。此外,采用它时可不需设置短岔开器,同时允许在相对侧上开始所述过程之前,在另一侧上有效地将此过程从开始进行到完成,并在将骨料取出的现场保持着岔开状态。
下面说明这种“环钻法”。当至少在一侧上完成了将所述间隙暴露后,将硬膜囊与神经根牵开。取一个与此优选实施例中的长而坚固的岔开器不同之处仅在于其筒部较脊椎植入物具有严格地稍小的直径的长岔开器。正如此优选实施例中的情形,外套的内径仅仅是略大于拟插入的植入物。于是在此时,将一第一内套插入外套中来补偿长岔开器的外径与外套的内径之差。将如上组配好的外套与第一内套放置到长岔开器之上,并应用前述的冲击罩使此外套处于最佳位置。撤除此罩与第一内套,使长岔开器与外套留于原位。
让此长岔开器保持于最佳岔开状态,并由外套将脊骨锁定在一起来制止脊骨的任何运动,此时用称之为环钻的一种空心管状切刀插过长岔开器及其筒部的到达外套之内。此环钻停止到一适当深度处,此时可以用来从相对的脊骨端板上切下相等的弧形骨段。
另外,可将一第二内套在上述环钻放置于长岔开器之上和来到此第二内套之前设置于外套之内。此第二内套的内径刚好大于长岔开器,而其外径则刚好小于外套的内径。这固然可以提高环钻的稳定性,但在同时需要在岔开器的外表面至其筒部上沿纵向或斜向设置一些大的出屑槽,用以容纳切削过程中产生的骨屑与软骨屑。
在由以上任一种方法把环钻用到了一适当深度下时,便将此环钻、长岔开器与第二内套(如果用到了时)一并撤下。由于环钻只是切下两个弧形骨段而并未对它们铰孔,于是再将一个在其工作端带有垂直切削部的轴式装置平行于椎盘间隙插入,然后通过弧形转动对此两个纵向切削出的弧段的底部进行切削,这样就可使它们经过外套撤出。必要时可对此空隙加工出螺纹,然后根据所述优选方法将植入物插入。正如业已指出的。此“环钻法”可在相对侧上用或不用短岔开器。
在脊椎其它区域中所采用的方法
下面的方法是在胸椎与腰椎中进行前方体内融合的优选实施例。但当颈椎的前方宽度足以能并列地放置两个植入物,而且能使得每个挤入物至少能有几个毫米进入到相对脊骨的物质中,同时植入物的长度合适时,则此种方法也适用于颈椎。
将待融合的间隙适当地暴露,并将软组织与活体结构牵开到各侧并加以保护。由于相对这部分脊椎不存在神经结构,故可凭视觉判断此种间隙在前方的宽度。将此间隙的前方位的中心线记下并标出。首先用刀,然后用刮刀,必要时再用修骨钳取出椎盘。另外,在钻孔阶段也可将椎盘原样地留待以后除下。但根据此方法的优选实施例,在已从前方除去大量细胞核和大部分环带后,是将直径渐次向其工作端增大的长岔开器插入位于上述中央标记线与观察到的脊椎前方位侧向范围之间的一个中点的上述空隙内。
此时将带有其共用踏板与保持叉的双重外套插到一单独放置的长岔开器上,然后到放置好的第二岔开器上,或把它置放到业已安放好的两个岔开器上。至此将双重外套相对于脊椎前方位牢靠地定位。在插入长岔开器之间,任何有碍于踏板相对于脊椎前方位平齐定位的突出物部都得去掉。一旦外套就位于最佳位置时,便将长岔开器中之一撤出,并在其所在位置上插入一内套和钻头。此钻头的外径即相当于待插入的植入物的螺纹内径。内套的厚度基本上等于带螺纹的植入物的螺纹内外径之差。
然后用一限程钻孔器来加工两相对的脊骨表面并除去其间剩余的任何椎盘料。必要时可将一个限程丝椎插过外套进入所述空隙内以形成螺纹。再将经适当制备好的植入物固定到插入驱动件上,通过外套而向下进入此空隙,插入到直至其插入深度为此插入驱动件上的止动件所限。现在使此植入物本身处于一个起岔开器作用的位置上,从相对侧上卸除长岔开器再重复此过程。当两个植入物已牢靠就位后即可撤除外套。此时可在直接观察下来调节植入物的埋入量。
优选实施例的详细说明-方法与装置
在此优选实施例中,两相邻脊骨(V)之间的椎盘(D)是通过对此相邻脊骨进行双侧成对的半偏侧椎板切除木而成为可以通达的。在此优选实施例中,棘上韧带、棘间韧带、棘突、部分神经板以及绝大多数小眼面关节均保存下来。但尽管很少需要如此,这些结构是可以移去的。
在此优选方法中,通过环形纤维组织后向方位所形成的双侧孔,进行了双侧的部分细胞核切除。虽然很少愿意如此,但在钻孔过程中可以推迟锥盘的切除而在同时进行脊骨切除。从第一侧开始,放置一硬神经根牵开器,使得硬膜囊与下神经根从中间回缩,以从后方暴露出两相邻脊骨体与中间推盘的一部分的一侧。
现在参看图1,最好是在除去核心椎盘材料的某些部分后,将一个长岔开器100在直接观察下插入到脊骨间空隙内。框盘贯穿部102基本上为圆柱形,其带有一个子弹性的前端103和一个肩部104,贯穿部102即在此肩部处从管筒106延伸出。贯穿部102将脊骨体推开,便于将有关装置引入。然后引入带有直径依序增大的贯穿部102的长岔开器。当达到贯穿部102的最佳直径时,两侧上的脊骨体受迫压成为完全一致而因此平行,不仅与贯穿部102平行而且相互平行。此时,此后椎盘相邻的未曾除去的后脊骨体上的任何遗留的突起物,由于迫压的冲击作用,例如由于冠部110的槌平面109所冲击,将肩部104驱压抵靠脊骨V的唇部,而变得压平与脊骨体平齐。由于脊骨端板迫压对抵贯穿部102而具有最佳的岔开程度。此长岔开器100就绝对地垂直于后脊骨体的平面并绝对地平行于脊骨端板,而使所进行的过程能有最佳的对准关系。
市售的贯穿部102可有不同的直径,但都具有小于上述周知的脊骨间间隙的深度的恒定长度。这同大到不可能配合到此间隙内的周围肩部104相结合,就可防止过度穿透的危险。管筒106的直径与待植入的装置的外径相同。冠部110下方的凹槽部108可用来使长岔开器100为图9所示的取出装置相结合。
在此优选实施例中,将一可变换的长岔开器113应用在脊椎的第一侧上。如图2所示,此可变换的长岔开器113有一个可与短岔开器部120分开的管筒152。虽然可以用一种坚固的长岔开器来进行初始的分开,但采用相衬的可变换的长岔开器可以达到最佳的岔开程度。此可变换的长岔开器113包括一个短岔开器部120和一个在一端有一矩形突起134的管筒152。短岔开器120有一个直径增大的头部128,一个矩形槽118以及一个内螺纹孔114。管筒152是空心的且有一个其一端是一个大直径六角形冠部115的内轴111,以及一个直径缩小部分112。此冠部的平表面中有一掣部117。轴111的另一端有一与螺纹孔114相对应的小的螺纹件116。轴111借助依常规方式通过管筒152壁部的定位销139而得以防止从管筒152上脱下。短岔开器部120以可卸下的方式通过矩形凹槽118与凸配合件134的相配合而接合到管筒152上。这种配合是利用按钮136来驱动连接到内轴111上的上述冠部110而保持到一起的,内轴111在一个带螺纹的工作端116拧合到短岔开器120的凹孔118中。
罩136有一个用来配合到冠部115周围的开口座138且同时其与直径减小的六角形部112相接合,以使轴111和凸螺纹件116能转动。开口座138内的一个定位球150与上述冠部115内的掣部117相结合,而把它们保持到一起。
图2、3与3A-3F中所示的短岔开器部120是设计用来在临时定位时提高稳定性的,得以在第二侧进行外科手术时制止不经意的有害的移动。为此目的,图3与3A中所示的短岔开器120的实施例有一对尖锐的榫126,其嵌入到相对的脊骨体中以及面向前的棘齿124,其能进一步抵制反向运动。表明此优选实施例的图3B与图3C乃是上述岔开器部的另一实施例的侧视与顶视图,此插入到脊骨间的岔开器部基本上是圆柱形的,但周边带有面向前方的棘齿124。
另一个实施例则示明于图3D和图3E中。这是一种较为矩形化的设计,其带有面前向棘齿,但设有图3中所示的尖锐的榫126。图3F是短岔开器120的又一实施例的侧视图。它带有滚花以加强与骨面的配合,从而提高对相应装置的稳定性并用以抵制移位。为此,上述长、短岔开器的工作端显然可有各式各样的与其目的相一致的构型,而且这样的表面不规则性以及工作端本身的形状,加或不加上榫126,都可以用来使短岔开器120更能批制移动。
一旦在脊椎的第一侧上实现了理想的岔开,这种可变换的岔开器便分离开,将短岔开器120保持于原位,以其圆形外端128安全地处于渠道板上并深入到硬膜囊与神经根。
如图4所示,此时外科医师来到脊椎的另一侧的同一椎盘(D)的高度处,并从中间牵开硬膜囊与神经根,使椎盘在这一侧暴露。然后将长岔开器100顺序地插入此椎盘空隙,直至此岔开器在此第二侧上的直径至少与在第一侧上的同样大为止。要是位于这一间隙的某种不对称性,需要与第一侧相比在第二侧上有一直径较大的岔开器来实现理想的岔开时,则在第二侧上配合一较大直径的短岔开器,而外科医师此时将返回到第一侧。在这种情况下,即将第一侧短岔开器120卸下,而把与原先设置的短岔开器120的加大了的直径相对应的长岔开器100插入。在上述任一种情况下,此项作业都将在放置有长岔开器的一侧继续进行。在此应该注意到,通过使用例如米切尔森脊椎外科手术床(MichelsonSpinal Srugery Frame),能够在手术作业之前获得合适的岔开量,使得外科医师要么不打算采用岔开器,要么仅仅是将正确的长岔开器放置到第一侧上,然后在移向另一侧之前在这一侧进行外科手术。这样的变化是在本发明的范围内的。
长岔开器此时为图5所示的空心外套140起到一定心柱与一定向棒的作用,此外套配装到长岔开器100之上,如图5中虚线101所示。外套140为金属的,并有一个带尖锐齿的前端142,能穿入两相邻脊骨(V)之间并牢牢地保持住它们。使前端142的周向尖锐齿中断开部是一些平整的区域152,它们用来阻止尖锐齿进一步插入到脊骨体内。外套140的带尖锐齿前端142是管状轴144的一个接续部分,此管状轴146又连到具有便于操作的滚花外表面148的周向加大的管状后端146上。外套的另一种实施例包括有一可胀大的键孔与槽构型154,它设在轴144的任一侧上,沿着前述间隙的中平面并与之平行,从而使得此端部142能抵制脊骨(V)相对椎盘(D)的任一侧塌缩,而当植入物的仅有直径即根部直径大于所钻的孔时,则能允许脊屑进一步岔开。
取冲击罩形式的驱动罩160在其远端有一平的封闭的后面162,而在另一端则有一宽阔的圆孔。驱动罩160配合到外套140与长岔开器100两者之上。当驱动罩160就位后,内表面170即沿圆周结合着外套的部分146,直至后端172接合上内肩164。当对表面162进行槌击时,冲击力经内肩164传送给外套140,经过其远端172、定位齿142至与椎盘空隙D相邻的脊骨体上,而进入脊骨体为齿142的深度,直到平整部152。随着外套140的向前推进,长岔开器的冠部110便可以无阻碍地突入到驱动罩160内,直至接触到平整的内表面168。一旦冠部110接触到平整的内表面168,则再进行槌的击打也不再会推进外套,任何进一步的运动将为与后方脊骨体的硬表面相抵靠的长岔开器的平肩部104所阻止。这样,外套140完全和可靠地插入至其最佳深度并牢靠地固定着两个相对的脊骨,如图6所示。
此时除下罩160,并利用图9中所示的岔开器抽出件200从脊椎上除下长岔开器100,而将外套140留于原位。岔开器抽出件200具有前部202、中部204与后柄部206。在抽出件200的前部202上,有一插座208连接着轴210的一端,此轴的远端则与后柄部206相连。插座208中界定出一空腔212,此空腔的前端是敞开的而在其侧部的内部方位上呈漏斗形。空腔212构造成,使得岔开器抽出件200的头部与部分周边凸缘218接合着岔开器100的周边凹槽108。空腔212的入口略呈漏斗形,且凸缘218的前边缘218略倒有圆角,以便凹槽108与岔开器100的头部110配合,当驱动罩160留下岔开器100的部分108精确地与外套140的后表面172平齐时,就能进一步方便上述配合。这样就提供了一个大的平整表面171,以精确地导引插座208的表面230以及在头部110周围的开口部212,与此同时,凸缘218则与凹槽108配合。弹簧加载的定位球228接合于冠部110的半球形凹入部112中,如图2所示。与辅助定位218相接合的这一弹簧加载的定位球228,能防止长岔开器在其已从外套140内撤出之后和从伤口撤离之前,从抽出件200上偶然脱下。一旦从人体上脱离,这两个装置便易于分开,即只需通过人手的力量垂直地作用到它们相连处的相对长轴线上,使冠部110与空腔212相分开即可。
在前部202与后柄部206之间,围绕轴210配装上一圆筒形的和可自由移动的重物216。使此重物216缓慢地和重复地沿轴210滑动并朝后驱向平表面228,将一后向矢量传递给近端202,而由此传递给与之接合的岔开器100。
当把所述装置用来松释开长岔开器100时,可用一对延伸的手柄224与226来使外科医师能够阻止任何过量的后向运动。此成对的手柄224与226也可用来通过轴210转动地导引部分208。这样就可允许外科医师可旋转地控制和操纵空腔212的开口方向,以便于将它应用到岔开器100的头部110。
岔开器抽出件200显著地改进了同一个独立的槌超过暴露的手术伤口去打击一取出装置或是用手强拉动来撤出岔开器的其它方法。在敞开的伤口上方使用一个自由槌是危险的,这是因为神经结构会由于槌的回摆而会碰触到,而这种情况更可能来自槌头上的重力影响。通过拉动用手来抽出也是危险的。这是由于部分102是在脊椎内作显著的压配合,因而需要显著的力来取出岔开器100,而要是此力是不同轴向的,则外套就可能移位和失配。此外,一旦此平整部102脱开所述间隙,则对拉出的所有阻力都将丧失,而在面对需要很大的力来松释开它的情形下,岔开器100可能易成为抛射物而伤及病人和/或此外科医师。
一旦将长岔开器100从外套140上完全撤下时,外套140的带齿的端部142使同相对侧上的短岔开器120配合工作,而牢靠地保持住相邻脊骨V的相对位置。此外,由于在脊椎这一侧上的手术过程的其余部分是完全通过保护外套140来进行的,还由于神经与硬膜囊是在此外套之外和处于外套140的带齿的端部142的表面之上,而此带远端部142又是牢牢地嵌入相邻脊骨V之内,于是外套140能用来确保这些精细神经结构的安全性。此外,由于外套140具有固定长度并且是刚性的,它的平整的后向表面172可以用作通过外套140设置的所有装置前进的止动件,这样就能防止偶然过度穿透。外套140还能保证继后的过程能相对于椎盘空隙D同轴线地进行,并且相对于各个对峙的脊骨表面是对称的。
图10B是脊椎在此过程阶段的后视图,示明一短岔开器120就位于脊椎的一侧,而外套140的底部则位于脊椎的相对一侧。
参看图11A,内套242从后方插入外套140内。此内套有一已知厚度的环部244,它相对于外套140的顶边缘表面172定位。内套242的圆柱形筒部在完全定位时邻近于外套内的脊骨体的后向方位。具有一已知选定长度的钻具240通过内套242的后向孔引入,并用来铰出它从相对脊骨端板上所接合的弧形骨段和铰除在其向下到达其预定和有效深度的路径上的任何椎盘材料。钻具240具有一窄的接合部246,其可以固定到一可以是手动或电动装置的驱动机构上。有一直径增大的周缘环件248用来限制钻具240的穿透深度,并加以固定或能作锁定地调节。
在此未加以示明但为本技术技术人员所熟知的多种机构,可用来锁定式地调节例如钻具之类的装置。这类机构包括但并不限于应用锁圈,带锁定螺母的螺纹轴,以及上面配合有强制形成的槽的凸缘,这些槽或是通过把一个罩套合在或拧合到凸缘上而形成的。
在此优选实施例中,钻具240的前向切削刃252是对大型槽式钻具设计的一种改进,使得其端部类似于一种端切削铣刀,它可以包括任何可工作数目的切削面,但最好是四个或更多,而且这样的切削面较浅,得以较慢地推进相应的装置。钻具240的外径对应于带螺纹的脊椎植入物较小的内径。内套242的内径则较钻具的外径稍大,而其外径则略小于外套140的内径,该外套的外径则与上述带螺纹的植入物的外径相同。
钻具240的钻轴包括上部243、小直径的中央凹部256以及下切削钻削部250。钻具240的上部243与下部250具有相同的外径。
内套242有多种用途。首先在所要钻的一个比外套140的内径较小直径的孔时,可为钻具240提供较密切的钻削导引。其次,由于它此时在导引钻具,就可使外套140所具有的内径大到足以接纳带螺纹的脊椎植入物,此种植入物在直径上实际上是大于钻具240的。
要是采用不带内套242的外套140,则钻具240将会在较大空间的限度内自由摇摆,而不能可靠地平行地从相邻的脊骨V上切除相等部分的骨料。此外,所除去的骨料不仅需要相等,而且必需在三个方向上正确地定向。这就是说,钻具240的路径必须均匀地定心于椎盘间隙内,平行于端板,同时平行于分割所述间隙的径向轴线。
内套242的另一个用途是它可以与钻具240同时取下,这样就可收集钻孔过程中产生的软骨屑与骨屑,这些骨屑是通过钻削部250上的大槽251引导向后方,然后收集于凹部256和内筒242的内壁之间的凹部256的周围。这样,在卸下钻具240并连带内套242时。铰孔过程所产生的骨屑便能可靠地从脊椎通道与伤口区域取走。
此外,要是事先已将拟铰孔的区域中的椎盘组织取出,则根据这一优选方法,可把病人本身质量良好的和可用于此项手术中的骨料置于轴凹部256和内套242之间。这种骨料在从手术创口取出后,可用于加到脊椎植入手中或深放到所述间隙内而参与融合。
实际用于在脊椎上形成手术孔的方法是多种多样的。如图11c所示,在另一实施例中,钻具端部250有一前向的乳头状突起260,此突起本身在其前方位为子弹头形,以便易于进入椎盘空隙并将脊骨推迫分离。突起260起到岔开与稳定作用,且其得以阻止两相邻脊骨任何移回到一起的倾向,并在与套140和242相结合工作时对于钻削部250是自定心的,同时能在实际上保证从相对的脊骨面上将脊骨对称地剖开。
本申请中前面述及的另一种“环钻法”示明于图11B中。在此选择方法中,在外套140就位后将长岔开器100留于原位。这种情形下的长岔开器100与优选实施例中的长岔开器的不同之处在于,它的筒部106的外径与现有形式的相比较小。这与本方法无关,之所以需要如此,是因为要形成与脊椎植入物的小直径相对应。环钻270是一种空心的管状件,在其近端带有锐利的切削齿251,其有一定的厚度,而由于此环钻270的外径必须对应于植入物的根部直径,于是环钻270的壁厚就必须允许长岔开器100作相应的减小。
对这种“环钻法”的长岔开器100的另一种改型是沿着筒部面106利用一些纵向槽(未示出)朝后方输送切削过程中产生的任何骨屑。由于切削件既为此长岔开器定心又定向,因此就不一定要采用内套242,但可以把它再次用于控制骨屑的输送路径。为此目的,在此种“环钻法”中是产生小的骨屑的,因为对骨的弧形段并未作大的铰孔和取出,只是对留下来连接其远端的弧形骨段处才在骨内切削。这样,当完成环钻法并将环钻270与内套242取下时,与钻有孔的优先实施例不同,在此只需取下两段弧形屑和任何介入的材料,而这是极易用各种装置来完成的。其中之一示明于图11D中。
装置272包括一个偏心地安装于手柄274的下表面273上的轴276。轴276的终端是一个切削臂278。装置272插过外套140,到使手柄274的下表面273抵靠外套140的顶部172位置,此时装置272停止向下运动并精确地使其切削臂278垂直定位,以便让手柄部274转动而切削臂278也同时转动,切下弧形骨段并使之从其最后连接处分离下。然后用此装置或一个长的镊子把它们取出,再放到植入物中或是用来参与融合。
虽然在本发明的优选实施例中,脊椎植入物工实质上是自攻螺纹的,但要是骨头反常的硬,就可能要在插入植入物工之前在所述间隙内形成螺纹结构。为此目的,如图12所示,丝锥280有一螺纹切削部282经轴286连接至一手柄部292,手柄部292设计成从机械角度便于转动此丝锥来切削螺纹。柄部290的下部有一前向平面件288,其大到不能配合通过外套140的孔口,这样就能安全地限制切削部282的穿透深度。为进一步确保丝锥280的安全性而为它设计了一个钝的端部294,它正好在肩部288压贴到表面172之前接合上脊骨的未切削部分。这一特点可使外科医师感知到一种不太猛烈的阻力,这是因为此时的钝头端294碰合上供钻孔用的其余的未剖开的骨,且这种情形出现在肩部288落定到顶边表面172上而引起阻力突增之前,这样的第一次的阻力就可用来警告外科医师中止攻螺纹的过程。于是此外科医师就能具有视觉(在肩部288逼近顶边表面172时)与触觉两方面的警告,得以避免剥伤螺纹形式。丝锥端282是经过特别专门设计的以用于其专门目的。在专门设计的钝头端294的后方是一平截头锥的子弹形区域298,它一直颂斜到具有恒定直径的切削刃296的中部。斜坡部298促使相对的脊骨体分开,这种运动受到外套140的阻挡,这样就渐次地将螺纹形式的切削刃296的锐利前刃驱入到脊骨体内。间隔排列的纵向槽284可有1至8个而最好是4个,截断这种螺纹形式,用来聚积螺纹切削过程中要加以除去的骨科。为此目的,在这一理想的实施例中,是把螺纹切削形式设计成来压缩待成形的量料而不是通过它开槽。此外,虽然丝锥280的螺纹内-外径可以变化,但在此优选实施例中,它的螺纹内径对应于植入物工的螺纹内径,而它的螺纹外径则略小于植入物的螺纹外径。
现在取出丝锥200而将外套140保留于原位,此时的手术现场已完全准备就绪来装置脊椎植入物I。在脊椎植入物的这一优选实施例中,此种植入物通过应用和充填融合促进、增强和参与的物质及因素,已然得到了改进。这样,此种植入物可以认为是已完全准备好可提供给手术中的外科医师供插入之用的。但在当前,人骨是最普通用作选择的移植材料的,而且视病人本身的骨为最好的移植物源。
图14a所示的一种环钻300,其带有一极其锐利的前切削刃302,用于在病人后方髂骨顶部中快速而干净地装入骨芯或是任何其它骨组织,同时用于生产一种在以后放到环钻300的空心304内的骨芯。环钻300的后部306带有一对径向相对的槽310,同时从它们的纵向顺着时针方向配置有后向孔,得以从径向上配合上驱动装置308上的相对部件312,由此,环钻300可以由手或动力钻床来结合。可以看到,由上述相对部件312形成的结合机构在顺时针方向切削过程中是稳定,同时还能允许上述两部件在切削完成之后迅速的脱开。
由于移植物与空心部304的内壁之间有很高的干扰效应,同时正被取下的网状骨在强度上又是较弱的,故可在仍然钻孔的同时撤下环钻300,并随它抽出骨芯。但在极少有可能出现的骨芯仍保留地固定于其骨底上的事件中,则卸下驱动机构308,将图14c所示的螺丝起子408穿过后部306的中央孔,向下旋拧并通过空心部304内的骨芯,达到齿302的深度。螺丝起子408的梢端318基本上是与此螺旋起子的外皮处于同一直线,其然后沿径向通过骨芯的底部切割。当起子408的手柄部314贴抵住后部306的平的后表面时就不能再向前推进。随着起子408继续转动,就将促使骨芯从后方拉出,尤如从酒瓶取出瓶塞那样。环钻300有一个筒状空心部304连接着锐利的齿部302,此空心部的内径恰好小于待装置的脊椎植入物I的内径。
环钻300及其获取的骨芯此时放置成如图14B所示,通过植入骨安装装置320的孔口340,然后筒部304通过这里并为图形凸缘344阻挡。此装置320的冲头轴126这时已准备好为反时针转动的旋钮332所结合,使得此冲头372经由长的带螺纹的轴部328拉回到在基近端的轴环330的庇部。在此位置上,旋钮332从轴环330朝后延伸出较大部分。在冲头轴326处于上述位置时,此冲头的头部372即插入环钻300的中央空心部306,而作为轴环330的近端柱形部则依随着它,使得冲头372此时占据着筒部304的后向部分而轴环330的近端柱形部分则占据着中央空心部306。轴环330上的两个沿径向相对的径向突出臂346于是便沿纵向推进到径向相对的两个L形槽340中,然后顺时针转动来完成这一装配。
在上述装置320的另一端,脊椎植入物I通过它的矩形凹槽364为一从端塞324的后向面延伸出的矩形突出条(未示明)所接合,并为一旋钮334固定,此旋钮334作为一种棒形件通过端塞324的一个中心孔而延伸到其作为一个小螺栓的远端,而此螺栓则旋入到脊柱植入物I的凹槽364中央的一个凹孔内。将脊柱植入物I固定于端塞324之上而植入物I的相对端则给出一个空心的管状孔口,于是端塞324即推进到装置320为可旋转接合的径向相对的L形槽321的固定处。当装置320完全组装好时,环钻300的端部302即与植入物I的开口端共轴线且相对。
如图15所示,当旋钮332顺时针转动时,与螺纹轴328邻近的冲头372即受迫但是是受控地受驱的向前使筒部304向下,将骨的移植物直接排送入脊椎植入物I中。由于这一骨移植物在长度上大于脊椎植入物的内部长度,随着进一步压缩,此种骨移植物即受迫进入经向设置的孔内,这些孔通过上述装置的壁部,而从中心空腔通连到外部。
此时从装置320中撤出端塞324。把端塞324用作一手柄,而把图16所示的端盖374固定到脊椎植入物I的开口端上。反时针转动旋钮334,即可使此植入物从端塞324上退下。
图16示明一种植入物驱动装置,它可用来插入或撤出所述植入物I。此驱动装置350在其远端362处有一矩形突起398,此突起与植入物I的互补矩形槽364密切相配。从端部362的矩形突起398上凸出一螺纹部353,它呈棒状延伸出,通过空心轴358与空心手动筒360,到达它可受旋转控制的旋钮354处。螺纹部353旋入一凹孔中央槽364中,此螺纹部353进入中央槽364后便结合到一起,使得驱动装置350可通过成对的与径向相对的延伸臂366依任一方向转动,并在同时保持与植入物接触。
固定到驱动装置350上的这一植入物此时即被引过外套140,并拧入两个处理好的脊骨V之间相对的间隙内,直至冲击罩374的前边缘到达加工出的孔的深度,在此时刻,冲击罩的前进即受到尚未钻孔的处于其前方的骨所阻碍。这样就能让外科医师逐渐感觉到植入物拧到了底。
如前所述,当采用丝锥280,那种对进一步定位时在终端受阻的阻力就为外科医师提供了显著的感觉反馈。此外,由于使用了丝锥280,通过观察筒部360在它趋近外套140的后面172而逐渐接近的前表面370时,可使外科医师能由视觉监控植入物的插入深度。虽然如此,但设有一个最终安全机构,使得在已实现全深度插入时,上述装置350的表面370将抵靠外套140的表面172,而阻止对脊椎植入物作任何进一步的安装。
一旦此植入物完全安装好后,依反时针转动旋钮354就能使驱动装置350从植入物上脱开。然后从外套上撤下驱动装置350,再将外套140卸下。这样就使得植入物完全安装好并插入到预定深度,如图18所示。
现在将注意力转向脊椎的另一侧或第一侧。用一种铝钢制的神经根牵开器将神经结构从中间牵开,使短岔开器120的头部128进入全视野,平齐地位于通道底板之上。应用装置152,在其延伸的矩形部134接合到短岔开器120的凹矩形部118时,将延伸的螺纹部116插入短岔开器120的凹螺纹部114内。然后转动后向部108与110,利用图2的旋钮136,恢复长岔开器的构型。
在硬膜囊与神经根仍然被牵开并受到保护的条件下,利用驱动罩162使外套140滑合到重新结构起的长岔开器之上并且定位好。将业已述及的使脊椎植入物I安装就位的整个过程重复,即可使两个脊椎植入物并列地设于所述间隙内。尽管不是必须的,但可以另外对待融合的平面进行其它的内部固定方法,然后依常规方式封闭伤口。
参照用于前方体内融合的优选方法与
装置的附图所进行的简单讨论
包括对在体内进行预岔开和应用护套
系统的公开
由于不存在脊髓与神经根,一般能在某一场合下对整个颈椎、胸椎或腰椎,从一侧到另一侧来观察椎盘空隙的整个宽度。在前方的体内融合的优选实施例中,植入物是并列的从前方到后方平行于所述间隙设置,并延伸入相邻的脊骨体内。当椎盘空隙的横向宽度不足以允许使用两个植入物时,则每个植入物可能大到足以能突入相邻脊骨内达到所需深度。于是可把单个的显著较大的植入物放置于中央。记住这一点,再根据上面对后方腰椎体内融合方法所提供的技术与装置作过的非常细致的描述,就只需对成对植入物的前方脊椎体内融合作一简单的讨论即可,同时,用来安装一个大的单独的中线移植物的方法也成为容易理解的。
先从前方暴露出待融合的所述间隙。牵开软组织,保护到任一侧,必要时保护到上侧与下侧。这样就能观察在前方邻近此空隙的脊骨的整个宽度。正如前面所讨论到的,外科医师已对合适的病人的X光照片进行放样来确定所需的切剖和最佳的植入物尺寸。在优选的方法中,外科医师然后要广泛地处理大量的核心椎盘部分(或者可把椎盘留下来在以后通过钻孔器取出)。这时外科医师即由前方从这一侧到那一侧记录下和标出处于中间的点。然后他将长岔开器100插入,使此岔开器100定心到刚刚注明的这个点和从前方观察脊骨间空隙的横向范围之间的一个位于中途的点上。所用的岔开器100的外筒部106要与待安装的植入物的外径相适应。所插入的岔开器的梢端102的直径是依次增大的,直至达到最佳的岔开程度。这种最佳岔开量虽可根据初始的放样给出,但也可凭视觉与触觉进行判定。当获得了最佳岔开程度后,两块脊骨端板就将完全一致并岔开器100的前轴部102平行,促使脊骨的定位变换并显著地加强了压配合和在前述梢端上的压力,使得插入的装置极其稳定。
外科医师可以觉察出有关组织已然通过其弹性范围运动到两上相邻脊骨V开始似乎成为一个单独实体来感觉和运动的地点。这些变化易于由脊骨重新定位成与梢端102一致的现象上观察出,也易于根据侧向X光照像结果认识到。但需是此外科医师未能得知业已实现了最佳岔开,而企图进一步岔开此间隙时,由于组织已运动到超出其弹性变形范围之外使阻力加大,他将发现极难做到这点。此外,也不会余留有弹性允许这对脊骨作进一步分离,而要是此外科医师有企图用槌子缓慢地将超尺寸的岔开器前推的念头,这样的念头也是很淡薄的。
现在回到手术过程本身,当把能产生理想的间隙岔开程度,且具有可与待安装的植入物相对应的筒部106的正确的体内岔开器100插入后,即把与此岔开器完全相同的岔开器等距离地从前方插向脊椎的另一侧。由于长岔开器100的筒部106与在端部上同轴地观察时的脊椎植入物具有完全相同的大直径,于是外科医师就能判断此成对植入物植入时所能具有的预期的并列关系。
如图7C与7D所示,此时将一对空心管组成的双重外套340插入到从脊椎前方突出的两个并列的长岔开器之上。此双重外套340所包括的两个空心管件在尺寸上一致,它们相互之间的偏移,理想上要相当于相结合的两个植入物大小直径差的和,但不得小于一个植入物的大小直径差,这是由于可能使得一个植入物上的螺纹套叠到另一个植入物的螺纹之间,使得它们两者之间会占据一个共同的区域。但是,虽然这一优选实施例略大于植入物的大小直径差(两者的和)的两倍,但可以认为这种距离是较大的。相反,在此优选实施例中,双重外套340的延伸的管部348是相互平行的,当它们之间的区域足够大时,这两个部件便有可能相互相对倾斜或偏移,使它们在其近端会聚或发散。此成对的管状结构348可在其整个长度上部分或全部的桥接起来,但是都由踏板344牢固定住。在这种双重外套装置的优选实施例的顶视图中表明,上述踏板基本上呈矩形,但不带有锐利的角部。
也可以采用其它形状。,从侧视图7D中可以看到,踏板344的外形经设计成能近似于脊骨的前方形状。从踏板344上向前延伸出一批锐利的尖状件342,它们长到使其足以能固定到脊骨上。尖状件342的长度限制成不得从后方穿透得太远,它们的数量为2至10个,但最好是6个。由于此双重外套340是利用图7E的双重驱动罩420与此外套340的后端352相结合而向前驱动,从踏板344上伸出的尖状件342便嵌入相对的脊骨体内,直至它们的向前运动受到弧形踏板344的阻止,此弧形踏板344此时变得与脊骨体的前向形状一致并为这样的形状挡住。
如在图5中所表明的,双重驱动罩420在设计上与单个驱动罩160的相同之处在于,有一个构型如标号168所示的凹槽354,允许将外套完全定位于其中而不妨碍长岔开器装置的后向突起。但是与罩160不同,区域354是较为不受约束的,因为它对于触合上长岔开器通过110这一部分的限制其向前运动的双重罩420来说并非是必须的,这是由于踏板344能起到这种作用。此外,用于双重外套340的双重罩420本身是取相对应的双重形式,它与后向的双重管部352相接合。一旦此双重外套完全定位好,待融合的与所述间隙相邻的脊骨便通过踏板344与尖状件342被刚性地保持住。这样就能根据已说明的方法,利用长岔开器抽出件200,取下任一个长岔开器或在必要时将这两个全部取下。然后外科医师可以选择在脊椎的一侧或两侧工作。根据前面的讨论,外科医师可以利用内套242对所述间隙钻孔,或根据“环钻法”,将长岔开器留在原位。
必要时可攻螺纹,然后通过保护外套340插入植入物。一旦将植入物完全插定,就将外套撤除。
在利用钻孔法或“环钻法”于带或不带内套条件下准备好融合位置后,在此优选实施例中是把外套340保留在原位,因为它能给丝椎280与植入物I提供理想的定位与定向。
可在预料到,希望在所述间隙内的深部工作,或最好能直接观察所用的丝椎或插入中的植入物的外科医师,是可以选择在插入第一假体之后或之前取下外套以保持稳定性的,这虽然并非是优选实施例,但是是在本发明的范围内。
用于前方体内融合法的优选实施例的
另一些方法
正如以前对后腰脊所述,可以另用业已详述过的“环钻法”。
作为另一种方法,应该注意到前向法中的关键因素是应用于预岔开原理,而岔开的结果是由带或不带长岔开器的外套所保持。于是,一旦完成了对间隙的准备工作,在本发明的范围(虽然不是优选实施例)内,是可以取下外套的,因为其中不存在需要保护的神经结构,然后直接地而不是通过外套插入植入物。
在作为此种方法的一种形式中,要使岔开的间隙的高度能让所要求的植入物的直径跨越此高度,同时深入到相对的脊骨体内这样一个程度,即使之不能并列地放置两个这样的植入物,然后只把一个直径显著加大的植入物放在所述间隙的中央而不是某一侧。通过本发明的方法与装置来安装单个的中央移植物是与业已描述过的方法相一致,而且能用钻孔法或环钻法进行。
参看图16-18,其中示明了本发明的脊椎植入物I的一种柱形实施例。在图16中,所示植入物I接附到插入装置350上。在图17与图18中,植入物I安装到相邻脊骨之间的椎盘空隙D内。
柱形植入物包括一空心管状件,它在优选实施例中是由ASTM的可由外科手术植入的材料最好是钛制成的。此柱形植入物I的一端封闭,而敞开的另一端则由一罩374盖住。柱形植入物I有一系列大尺寸的孔390通过它的侧壁。在柱形植入物I的周缘上形成有一系列的内螺纹392。任何形式的螺纹都可用在此植入物上。罩374有一个用来紧固它的六角孔口394。
尽管本发明业已结合带螺纹的脊柱植入物作了描述,但应认识到本发明的方法也可用于其它形式的植入物。例如可以采用由骨料或人造材料制的榫钉、有滚花的或是有不规则形状的柱形或球形件,或可以通过外套引入的任何其它形式的植入物。由于能够通过外套实行这种手术过程,就能使这种过程安全、快速和更为精确。
Claims (106)
1.一种用于进行融合脊骨外科手术的设备,此设备包括一空心管状外套,外套的一端有多个齿或尖状物用来接合两相邻的脊骨,所述齿基本上与所述外套的侧面相一致,使得所述齿或尖状物不会显著地加大所述外套的直径。
2.如权利要求1所述的设备,其特征在于,它包括有用来防止所述齿发生贯穿的防贯穿装置。
3.如权利要求2所述的设备,其特征在于,上述防贯穿装置是可锁定调节式的。
4.如权利要求2所述的设备,其特征在于,所述防贯穿装置包括有至少在某些所述齿之间的平整部分。
5.如权利要求1所述的设备,其特征在于,此设备包括一可卸下的空心管状内套。
6.如权利要求5所述的设备,其特征在于,所述内套在一端有一个大于所述外套的内径的轴环。
7.如权利要求1所述的设备,其特征在于,所述外套包括有限制其插入后从椎盘空隙中撤下的装置。
8.如权利要求7所述的设备,其特征在于,用来限制撤下的所述装置包括联轴节。
9.如权利要求1所述的设备,其特征在于,所述外套的上端有一加大了外径的部分。
10.如权利要求9所述的设备,其特征在于,它包括一种罩,所述的一端有孔,孔的内径大于所述外套的所述加大了直径部分的外径。
11.一种脊椎岔开器,所述岔开器包括一前部,它具有两相邻脊骨之间椎盘空隙的宽度;一个从所述前部延伸出的筒,所述筒有一第一端与一第二端以及一个较所述前部有加大了直径的部分;以及一个在此前部与所述加大了直径的部分的会合处的肩部,用来防止所述筒进入椎盘空隙内,而上述第二端则终止于一个头部。
12.如权利要求11所述的脊椎岔开器,其特征在于,所述筒的所述第二端具有一减小直径部分。
13.如权利要求11所述的脊椎岔开器,其特征在于,所述筒是可卸下的装附在所述前部上。
14.如权利要求13所述的脊椎岔开器,其特征在于,所述前部包括一第二螺纹部,用来啮合所述筒的第一端上的一相应螺纹部。
15.如权利要求14所述的脊椎岔开器,其特征在于,所述前部包括一啮合装置,用来啮合所述筒的第一端上啮的一相应的啮合装置。
16.如权利要求15所述的脊椎岔开器,其特征在于:所述筒包括一中央孔口和一有一第一端与一第二端的轴,此第一端有一第三螺纹部,用来啮合所述前部的第二螺纹部。
17.如权利要求16所述的脊椎岔开器,其特征在于,所述轴的所述第二端包括一具有减小直径部的头部。
18.如权利要求12所述的脊椎岔开器,其特征在于,它包括一能以可卸下方式安装的旋钮,此旋钮具有可用来松释啮合所述头部的装置。
19.如权利要求18所述的脊椎岔开器,其特征在于,所述旋钮与所述头部的减小直径部啮合。
20.一种用于进行融合脊骨外科手术的设备,它包括一对沿其纵轴线结合到一起的空心管,并在其一端具有一用来啮合相邻脊骨的啮合装置。
21.如权利要求20所述的设备,其特征在于,所述空心管是由一种踏板作刚性固定。
22.如权利要求21所述的设备,其特征在于,所述啮合装置是定位于所述踏板上。
23.如权利要求22所述的设备,其特征在于,所述啮合装置包括多个尖状件。
24.如权利要求20所述的设备,其特征在于,所述啮合装置包括若干个突起。
25.一种用来取出椎盘间隙内的岔开器的脊椎岔开器取出装置,它包括:一根轴;一个用来在一端装附到一脊椎岔开器上的装置,此装置的另一端有一加大了直径的部分;而在此轴的两端之间于轴上安装有可自由滑动的物质。
26.如权利要求25所述的装置,其特征在于,所述啮合装置包括用来啮合一脊椎岔开器的头部的减小直径部分的槽。
27.一种用于脊椎外科手述过程中的钻孔件,它包括一个钻头,所述钻头具有一下部、一小直径的中央部与一上部,所述上部与下部的直径相同。
28.如权利要求27所述的设备,其特征在于,此设备包括一止动装置,而所述止动装置则包括一在所述钻头的上部于一预定位置处的增大了直径的轴环,用来限制所述钻孔件的穿透程序。
29.如权利要求28所述的设备,其特征在于,所述止动装置是可锁定调节式的。
30.一种用于进行脊椎外科手术的一种设备,它包括一个空心管件,此管件的一端上有钻齿,此管件有一柱形突出部延伸到所述钻齿之外。
31.如权利要求30所述的设备,其特征在于,此设备包括一止动装置,所述止动装置包括一在所述管件的另一端上的肩部。
32.如权利要求31所述的设备,其特征在于,所述止动装置是可锁定调节式的。
33.一种用于脊椎外科手术的岔开器与钻孔器的组合件,此组合件包括一有齿的空心钻头和从其一端上延伸出的乳头状件,所述乳头状件则是在其远端上形成为一种脊椎岔开器。
34.一种用于脊椎外科手术的设备,此设备包括一手柄和一个轴,所述轴在一端上与所述手柄连接并有一个与此轴成一角度的切刀,且所述的轴是与所述手柄的中心轴线成偏心连接的。
35.一种用于脊椎外科手术中的植入物装载装置,此装置包括:骨料收取器,此收取器具有一第一空心管件,此管件的一端上有切削齿而在另一端上有一适配器;一第二空心管件,此管件的一端上有用来啮合一植入物保持器的啮合装置,而在另一端上有用来接受骨科收取器的适配器;所述第二空心管件围绕所述第一空心管件,以及一冲头装置,用来配合到所述第一空心管件内且从其中通过。
36.如权利要求35所述的设备,其特征在于,所述骨料收取器是以可卸下方式连接到用来啮合一钻孔器的钻头夹具上。
37.如权利要求35所述的设备,其特征在于,所述骨料收取器的内径近似于所述植入物的直径。
38.一种用于相对于病人身体插入或取出植入物的植入物取出/插入装置,所述植入物具有一般的柱形结构,在其外周边上有螺纹同时还有一中央螺纹部;所述取出/插入装置包括一第一管件,此管件具有与所述植入物的中央螺纹部相对应的螺纹和外径,同时还有一用来啮合此植入物一部分的啮合装置,在此,所述啮合装置是固定于所述植入物之上,且所述啮合装置相对于所述第一管件成可转动的关系。
39.如权利要求38所述的装置,其特征在于,它还包括一可锁定调节的止动装置。
40.如权利要求38所述的装置,其特征在于,所述植入物有一肩部,而所述啮合装置包括一用来固定到所述肩部上的一个对应部件。
41.如权利要求38所述的装置,其特征在于,所述啮合装置具有一个从其上面垂直延伸出的用来转动所述啮合装置的手柄装置。
42.一种用来将一种脊椎植入物插入两相邻脊骨间的方法,它包括:插入一空心管件,此管件具有用来将两相邻脊骨啮合到脊骨内的啮合装置;将一钻孔器通过所述管件,在椎盘和此两相邻脊骨的一个部分上钻孔;取下此钻孔器;将一植入物通过所述管件插入此脊骨中;然后取出所述管件。
43.如权利要求42所述的方法,其特征在于,所述植入物是柱状的。
44.如权利要求42所述的方法,其特征在于,所述用来插入植入物的步骤包括插入一或多个部分柱形体的植入物。
45.如权利要求42所述的方法,其特征在于,所述植入物有一个与由钻孔器形成的孔口的直径相对应的直径。
46.如权利要求42所述的方法,其特征在于,所述钻孔器带有一个用入限制钻孔的深度的装置。
47.如权利要求42所述的方法,其特征在于,所述深度限制装置是可锁定调节式的。
48.如权利要求42所述的方法,其特征在于,所述管件有一个可卸下的空心内套。
49.如权利要求42所述的方法,其特征在于,所述空心管件具有用来限制其穿入脊骨内的装置。
50.如权利要求49所述的方法,其特征在于,所述限制穿入装置是可锁定调节式的。
51.如权利要求42所述的方法,其特征在于,所述植入物是由人骨制成。
52.如权利要求42所述的方法,其特征在于,所述植入物是由能促进骨向内生长的材料制成的。
53.为权利要求42所述的方法,其特征在于,所述的在椎盘和相邻脊骨中的一部分上钻出的孔攻有螺纹。
54.如权利要求42所述的方法,其特征在于,所述管件有一个可卸下的空心内套。
55.如权利要求54所述的方法,其特征在于,所述孔是通过所述空心内套钻出,而所述空心内套则是对所述孔攻螺纹之前卸下。
56.如权利要求53所述的方法,其特征在于,所述管件具有一可卸下的空心内套。
57.如权利要求56所述的方法,其特征在于,所述孔是通过所述空心内套钻出的,而所述空心内套是在对所述孔攻螺纹之前卸下的。
58.如权利要求55所述的方法,其特征在于,所述空心内套的内径与植入物的根部直径相等。
59.如权利要求55所述的方法,其特征在于,所述空心内套的内径略大于植入物的根部直径。
60.一种用来将一脊椎植入物插入到两相邻脊骨之间的方法,它包括:将一脊柱岔开器插入脊柱一侧或两侧上的椎盘空隙内,以在脊骨之间提供一合适的椎盘间隙;将一个具有用来将两相邻脊骨结合到脊骨内的啮合装置的空心管件插到此脊椎岔开器之上;从空心管件上除下此脊骨岔开件;将一钻孔器通过此管件在椎盘与两相邻脊骨的一部分中钻孔;取下此钻孔器,通过此管件将植入物插入脊骨内,然后取下所述管状件。
61.如权利要求60所述的方法,其特征在于,所述插入物是柱形的。
62.如权利要求60所述的方法,其特征在于,所述插入植入物的步骤包括插入一个或多个部分柱形的植入物。
63.如权利要求60所述的方法,其特征在于,所述植入物具有一对应于由所述钻孔器形成的孔口的直径的直径。
64.如权利要求60所述的方法,其特征在于,所述钻孔器连带有用来限制钻孔深度的装置。
65.如权利要求64所述的方法,其特征在于,所述钻孔深度限制装置是可锁定调节的。
66.如权利要求60所述的方法,其特征在于,所述管件有一个可卸下的空心内套。
67.如权利要求60所述的方法,其特征在于,所述管件具有用来限制所述啮合装置穿入脊骨内的装置。
68.如权利要求67所述的方法,其特征在于,所述限制穿入装置是可锁定调节的。
69.如权利要求60所述的方法,其特征在于,所述植入物是由人骨制成的。
70.如权利要求60所述的方法,其特征在于,所述植入物是由能促进骨向内生长的材料制成。
71.如权利要求60所述的方法,其特征在于,它包括有在所述椎盘的孔内攻螺纹的步骤。
72.如权利要求60所述的方法,其特征在于,所述管件有一可卸下的空心内套。
73.如权利要求72所述的方法,其特征在于,所述的孔是通过所述空心内套钻出的,而所述空心内套是在对所述孔攻螺纹前取下。
74.如权利要求72所述的方法,其特征在于,所述空心内套的内径与植入物的根部直径相等。
75.如权利要求72所述的方法,其特征在于,所述空心内套的内径略大于植入物的根部直径。
76.如权利要求60所述的方法,其特征在于,在将一个脊椎岔开器保留于原位的同时插入一第一插入物。
77.如权利要求76所述的方法,其特征在于,所述保留于原位的脊椎岔开器包括一个筒部,此筒部可与椎盘空隙内的脊椎植入物的前部相分开。
78.一种用来将一脊椎植入物插入两相邻脊骨间的方法,它包括:将一脊椎岔开器于脊柱的一侧上插入椎盘中,以在脊骨间的椎盘空隙中提供适当的间隙;将一具有用来将两相邻脊骨啮合到脊骨内的啮合装置的空心管件插到此脊椎岔开器之上;通过此管件将一环钻通到脊椎岔开器之上,以在椎盘与两相邻脊骨的一部分上钻出一个孔;卸下此环钻;通过此管件将一植入物插入脊骨内;然后卸下所述管件。
79.如权利要求78所述的方法,其特征在于,所述植入物是柱形的。
80.如权利要求78所述的方法,其特征在于,所述插入植入物的步骤包括插入一个或多个部分柱形的植入物。
81.如权利要求78所述的方法,其特征在于,所述植入物有一个与由所述环钻形成的孔口的直径相对应的直径。
82.如权利要求78所述的方法,其特征在于,所述环钻连带有用来限制钻孔深度的装置。
83.如权利要求82所述的方法,其特征在于,所述深度限制装置是可锁定调节的。
84.如权利要求78所述的方法,其特征在于,所述深度限制装置包括一设在所述环钻内的肩部。
85.如权利要求78所述的方法,其特征在于,所述管件有一可卸下的空心内套。
86.如权利要求78所述的方法,其特征在于,所述空心管件具有用来限制啮合装置进入脊骨内的装置。
87.如权利要求86所述的方法,其特征在于,所述限制进入装置是可锁定调节的。
88.如权利要求78所述的方法,其特征在于,所述植入物是由人骨制成。
89.如权利要求78所述的方法,其特征在于,所述植入物是由能促进骨向内生长的材料制成。
90.如权利要求78所述的方法,其特征在于,它还包括在所述孔内攻出螺纹,同时所述柱形植入物是带螺纹的。
91.如权利要求78所述的方法,其特征在于,在将一个脊椎岔开器在椎盘中保留于原位的同时插入一第一植入物。
92.如权利要求91所述的方法,其特征在于,所述保留在原位的脊柱岔开器包括一个筒部,此筒部可与椎盘间隙中的脊椎植入物的前部分开。
93.如权利要求78所述的方法,其特征在于,它还包括有从所述环钻内活动和清除为此环钻切削下的各种剩余骨料的步骤。
94.如权利要求93所述的方法,其特征在于,所述切削下的各种剩余骨料是由这样一种装置清除出环钻,此装置包括一个手柄和一个轴,所述轴以其一端连接此手柄并有一个与所述轴成一定角度的切刀,同时所述轴是与所述手柄的中心轴线相偏心地连接到所述手柄之上的。
95.一种螺丝起子,它包括:一个手柄,一个螺旋件,所述螺旋件以其一端连接所述手柄而在另一端有一个与所述螺旋件成一定角度的切削梢,此切削梢实际上延伸到所述螺旋件的直径并与所述螺旋件的中心轴线成偏心设置,由此,转动所述螺旋起子就能促使所述切削梢沿径向切削出一条实际上与所述螺旋件的直径相对应的路径。
96.如权利要求95所述的螺丝起子,其特征在于,它还包括一个空心管件,部分地覆盖住所述螺旋件同时容纳由所述切削梢切下的骨料。
97.如权利要求96所述的螺丝起子,其特征在于,上述切削梢是自准直的。
98.一种用于脊椎外科手术的冲击装置,它包括:
一个脊椎岔开器,插入到两相邻脊骨的椎盘空隙内;
一个空心管状外套,它有一个带齿的前端和一个周缘加大了的管状后端,所述后端有隆起的冠状部;
一个驱动罩,它的一端上有一个封闭的后表面,而另一端上有一个前向圆孔,所述驱动罩在所述圆孔内界定出一第一大的凹槽用来啮合所述外套的管状后端,和一第二小的凹槽用来啮合所述冠状部,在此,所述冠状部无阻碍地突入到所述驱动罩的孔内,直至其到达所述小凹槽的表面。
99.如权利要求98所述的装置,其特征在于,它还包括有用来防止所述齿穿透的防穿透装置。
100.如权利要求99所述的装置,其特征在于,所述防穿透装置是可锁定调节的。
101.如权利要求99所述的装置,其特征在于,所述防穿透装置包括至少在某些所述齿之间的一些平整部。
102.一种在一端有一封闭的后表面,而在另一端有一前向圆孔的驱动罩,所述驱动罩在所述圆孔内界定出一第一大的凹槽用来啮合一外套的管状后端,和一个第二小的凹槽,用来啮合一冠状部。
103.一种用来将一空心管套安装到两个相邻脊骨上的方法,它包括:
将一脊椎岔开器插入到脊骨的一侧上的椎盘空隙内,所述岔开器有一个抵靠脊骨的平肩部;
放置好所述空心管套,此空心管套的一端上有一个用来啮合两相邻脊骨的啮合装置,此空心管套还有一个周缘加大了的管状后端,所述后端有一个隆起的冠状部,所述管套放置在所述岔开器之上,所述岔开器可用作所述管套的定心柱与定向棒;
将一驱动罩啮合到所述管状后端上,所述驱动罩的一端有一个封闭的后表面,而另一端有一个前向圆孔,所述驱动罩在所述圆孔内界定出一第一大的凹槽用来啮合所述管套的管状后端,和一第二小的凹槽用来结合所述冠状部,所述冠状部在所述第一与第二凹槽之间形成一内肩;
用一冲击装置将一冲击力施加到所述驱动罩上,由此使所述冲击力经所述内肩传送给所述管套,直至所述冠状部定位到所述第二凹槽内;
从所述后端取下所述驱动罩;和
用一个岔开器抽出装置取下所述岔开器,而让所述管套留于原位。
104.如权利要求103所述的方法,其特征在于,所述管套包括用来防止所述齿穿透的防穿透装置。
105.如权利要求104所述的方法,其特征在于,所述防穿透装置是可锁定调节的。
106.如权利要求104所述的方法,其特征在于,所述防穿透装置包括在至少某些所述齿之间的一些平整部。
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CN1128944A true CN1128944A (zh) | 1996-08-14 |
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CN94193049A Pending CN1128944A (zh) | 1988-06-13 | 1994-06-09 | 插入脊椎植入物的设备与方法 |
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US (4) | US6080155A (zh) |
EP (5) | EP0703757B1 (zh) |
JP (2) | JP3621111B2 (zh) |
CN (1) | CN1128944A (zh) |
AT (4) | ATE240701T1 (zh) |
AU (2) | AU7139994A (zh) |
CA (1) | CA2213819C (zh) |
DE (5) | DE69635564T2 (zh) |
DK (2) | DK1129668T3 (zh) |
ES (4) | ES2254830T3 (zh) |
PT (2) | PT1129668E (zh) |
WO (1) | WO1996027345A2 (zh) |
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1996
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- 1996-02-26 AT AT96907088T patent/ATE240701T1/de not_active IP Right Cessation
- 1996-02-26 ES ES03014398T patent/ES2254830T3/es not_active Expired - Lifetime
- 1996-02-26 ES ES01114044T patent/ES2220626T3/es not_active Expired - Lifetime
- 1996-02-26 DK DK96907088T patent/DK0812167T3/da active
- 1996-02-26 AU AU50258/96A patent/AU701744B2/en not_active Ceased
- 1996-02-26 DE DE29623246U patent/DE29623246U1/de not_active Expired - Lifetime
- 1996-02-26 WO PCT/US1996/002377 patent/WO1996027345A2/en active IP Right Grant
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