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CN100425214C - Methods and instruments for interbody fusion - Google Patents

Methods and instruments for interbody fusion Download PDF

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Publication number
CN100425214C
CN100425214C CN 200410028616 CN200410028616A CN100425214C CN 100425214 C CN100425214 C CN 100425214C CN 200410028616 CN200410028616 CN 200410028616 CN 200410028616 A CN200410028616 A CN 200410028616A CN 100425214 C CN100425214 C CN 100425214C
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CN
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Grant
Patent type
Prior art keywords
methods
instruments
interbody
fusion
interbody fusion
Prior art date
Application number
CN 200410028616
Other languages
Chinese (zh)
Other versions
CN1701772A (en )
Inventor
E·F·雷三世
L·M·博伊德
T·A·兹德布里克
Original Assignee
Sdgi集团有限公司
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    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/4455Joints 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
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Abstract

一种驱动工具,用于将体内融合装置植入到相邻椎骨之间的间隙中,所述的融合装置具有一个主体,所述的主体具有一个被相对设置的平直侧壁断开的圆柱形外表面,所述的外表面上带有外螺纹,所述的工具包括:一个细长的轴;以及一对通过铰接件与所述轴的一端连接的、彼此相对的夹钳,所述的夹钳彼此偏离开;所述夹钳中的每一个都具有一对被形成得能够与融合装置的相对设置的平直侧壁接触的向内的表面和一对被成形得能够与融合装置的圆柱形外表面相一致的向外的表面。 A driving tool for implanting the interbody fusion device into a gap between the adjacent vertebrae, the fusion device having a body, said body having a flat side walls being disposed opposite the cylindrical OFF shaped outer surface, said outer surface having external threads, said tool comprising: an elongated shaft; and, one pair of opposite tongs connected to one another by a hinge with an end of said shaft, said partial tongs away from each other; each of the jaws having a pair of inwardly facing surface is formed to be capable of contacting with the opposite flat side walls of the fusion device and a pair of fusion devices can be shaped to the cylindrical outer surface of the outer surface of the same.

Description

用于植入体内融合装置的驱动工具 Driving tool for implanting the interbody fusion device

本申请为1996年3月26日提交,申请号为96105961.3、发明 This application is March 26, 1996 filed Application No. 96105961.3, invention

名称为"用于恢复脊柱正常解剖形态的体内融合装置及方法"之申请的分案申请。 Entitled divisional application "in vivo for restoring the normal anatomy of the spinal fusion device and method" of the application. 技术领域 FIELD

本发明涉及一种用于放置到椎骨间的将损伤了的椎间盘取出之后留下的空隙中的人工植入物。 The present invention relates to a method for placing the left after removal of the damaged disc between the vertebrae an artificial implant voids. 具体地说,本发明涉及一种能便于相邻椎骨间的关节固定术或脊柱融合术、同时还能保持或恢复处于特定的椎骨水平上的正常的脊柱解剖形态的植入物。 More specifically, the present invention relates to an facilitating arthrodesis between adjacent vertebrae or spinal fusion, while also maintaining or restoring the normal spinal implant anatomy at the particular vertebral level.

背景技术 Background technique

在过去的几年中,为了排除引起下背部疼痛的因素而进行的脊柱手术的量稳步地增长。 In the past few years, the amount of spine surgery to correct the causes of low back pain has steadily on the increase. 最常见的情况是,下背部的疼痛由相邻椎骨间的椎间盘损伤或病变引起。 The most common situation is that lower back pain is caused by injury or disease disc between adjacent vertebrae. 这些盘可能会突出或发生各种变性, 这两种情况都破坏了椎间盘的解剖学上的功能。 The disc can be herniated or the occurrence of various degeneration, both of which were destroyed function of anatomical intervertebral disc. 处理这类情况的最流行的外科方法是融合围绕着病变椎间盘的两块椎骨。 The most prevalent surgical treatment for these types of cases is the integration of around two vertebrae disc disease. 在多数情况下,是通过椎间盘切除术将除纤维环以外的整个椎间盘都取出来。 In most cases, discectomy through the entire disc except for the annulus are taken out. 由于取出了损伤了的椎间盘,就必须将某些东西放入到盘内间隙中, 否则这个间隙就会萎縮,造成沿着脊柱伸展的神经的损伤。 Since removing the damaged disc, it must be something put into the intradiscal space, otherwise the space may collapse resulting in damage to the nerves extending along the spinal column.

为了防止这种盘内间隙萎縮,就必须用骨或骨的替代物填充这一间隙,以便将相邻的两块椎骨融合起来。 In order to prevent this disc space within atrophy, it is necessary to fill this gap with bone or a bone substitute in order to integrate the two adjacent vertebrae. 在早期的技术中,只是简单地将骨质材料放至相邻的椎骨之间,通常是放到椎骨的后部, 利用一个横跨病变椎骨的板或杆来稳定脊柱。 In early techniques, bone material was simply disposed between the adjacent vertebrae, typically onto the back of vertebrae, and a plate or rod spanning the affected vertebrae to stabilize the spinal column. 采用这样的技术,当形成了融合之后,用于维持脊柱部分的稳定性的部件就成了多余物了。 With this technique once fusion occurred the hardware used to maintain the stability of the segment became superfluous the. 况且,通过植入杆或板来稳定融合期间的脊椎水平所需要的外科手术常常既费时又复杂。 Moreover, spine surgery to stabilize the level during fusion implant a rod or plate often require lengthy and involved.

于是又提出,解决取出了椎间盘后的间隙的稳定性的更佳办法是:使椎骨在它们各自的端板之间融合,最好是不需要使用前插板或后插板。 It was therefore better way to solve the stability of the disc after the gap is removed: vertebrae between their respective end plates fusion, preferably the need for anterior or posterior plating. 人们进行了大量的努力来开发出一种既能用来代替损伤的椎间盘又能至少在形成完整的关节固定之前维持相邻椎骨之间的盘内间隙的稳定性的可接受的盘内间隙植入物。 Considerable efforts have been made to develop a both can be used to replace a damaged disc in the gap is formed at least within the plant before complete arthrodesis maintain stability within the disc space between adjacent vertebrae of acceptable intradiscal into the matter. 这些"体内融合装置"具有多种形式。 These "interbody fusion devices" have various forms. 例如,在几种更为流行的设计中的一种釆用圆 For example, one of the more prevalent preclude designs with round

柱形植入物的形式。 In the form of a cylindrical implant material. Bagby的4501269号美国专利、Brantigan的4878915号美国专利、Ray的4961740和5055104号美国专利以及Michelson的5015247号美国专利描述了这类植入物。 U.S. Patent No. 4,501,269 to Bagby, Brantigan U.S. Patent No. 4,878,915, Ray, Nos. 4,961,740 and U.S. Patent No. 4,878,915 to Michelson and U.S. Patent No. 5,015,247 describes such an implant. 如Ray、 Brantigan和Michelson的专利所述,在这些圆柱形植入物中,圆柱体的外部刻有螺纹,以便插入体内融合装置。 The patent Ray, Brantigan and Michelson, In these cylindrical implants, the exterior of the cylinder can be threaded to facilitate insertion of the interbody fusion device. 另一种方案是,某些融合植入物将被敲入到盘内间隙和椎骨端板中。 Alternatively, some of the fusion implants to be pounded into the intradiscal space and the vertebral end plates. Bmnt!gan的美国第4743256、 4834757和5192327号专利描述了这种类型的装置。 Bmnt! Gan in U.S. Patent, 4,834,757 4,743,256 and No. 5,192,327 describes this type of device.

在上面举出的所有这些专利中,植入物的横截面在整个长度上都是恒定的,并且一般都是直立圆柱形的。 In all of these patents cited above, the cross-section of the implant is constant over the entire length, and is generally a right circular cylinder. 还有人研制出了不具有恒定横截面的用于体内融合的其它植入物。 It was also developed without other implants in vivo of constant cross section for fusion. 例如,McKenna的美国第4714469号专利展示了一种带有伸至椎骨端板中的细长突出部的半球形的植入物。 For example, U.S. Patent No. 4,714,469 to McKenna shows an implant with an elongated hemispherical projection extending to the vertebral end plates. Kuntz的美国第4714469号专利展示了一种能优化该假体与相邻的椎骨体之间的摩擦配合的子弹头形的假体。 U.S. Patent No. 4,714,469 to Kuntz shows a prosthesis to optimize the friction between the prosthesis and the adjacent vertebral bodies with bullet-shaped. 最后, At last,

Babgy的美国第4936848号专利中的植入物是球形的,该植入物最好是放置在相邻椎骨的椎体之间。 U.S. Patent No. 4,936,848 in Babgy spherical implant, the implant is preferably placed between the vertebral bodies of adjacent vertebrae.

体内融合装置大体上可分为两种基本类型,即实心的植入物和具有允许骨生长的结构的植入物。 Interbody fusion devices can be generally divided into two basic categories, namely solid implants and bone growth having a structure that allows the implant. 美国第4878915、4743256、4349921 和4714469号专利描述了几种实心的植入物。 And U.S. Patent No. 4,714,469 describes several 4878915,4743256,4349921 solid implant. 上面讨论的其余的专利具有允许骨穿过植入物生长的某些技术特征。 The remaining patents discussed above have certain technical features allow the bone implant through growth. 业己发现,利用能促进骨自然生长的装置能实现更快且更稳定的关节固定。 Industry has found that the use of means to promote natural bone ingrowth achieve a more rapid and stable arthrodesis. M!chelson 的专利描述的装置是这类空心植入物的代表,通常在将这类植入物插入盘内间隙之前先用自体的骨填充它。 M! Chelson patents describe apparatus is representative of this type of hollow implant which is typically filled first with autologous bone prior to insertion of such an implant within the disc space. 这种植入物带有一些与该植入物的空心内腔连通的圆孔,由此在椎骨端板与位于植入物中的骨或骨的替代物之间形成一条供组织生长的通路。 This implant includes a circular apertures which communicate with the hollow interior of the implant, thereby providing a path for tissue growth between the vertebral end plates located implant bone or a bone substitute. 在预备盘内间隙时,最好是使端板减小,以便向骨供血,从而有利于这一组织的生长。 In preparing the disc gap, the endplates are preferably reduced to bleeding bone to facilitate this tissue growth. 在融合过程中,由Michdson的植入物提供的金属结构对维持待融合的运动段的开放性和稳定性起到了帮助作用。 During fusion, the metal structure provided by the implant Michdson open and maintain the stability of the motion segment to be fused has helped. 此外, 一旦形成关节固定,植入物本身对实心骨体起到一种固定器的作用。 In addition, once arthrodesis is formed, the implant itself to work as a holder for the solid bony mass.

在现有的许多体内融合装置中仍然存在一些困难。 There are still some difficulties existing in many interbody fusion devices. 尽管己经认识到使骨能够在植入物内的骨或骨的替代物中生长的空心植入物是实现融合的一种最佳技术装置,但多数己有装置难以实现这种融合, 至少是在没有某些附加的稳定装置(如杆或板)的帮助下难以实现这种融合。 While have recognized that permit bone growth in the bone or bone substitute within the implant in the hollow implant is an optimum technique for achieving fusion device, but most devices have been difficult to achieve this convergence, at least this fusion is difficult to achieve without the aid of some additional stabilizing device (such as a rod or plate). 此外,这些装置中的有一些在结构上不够结实,不能承受最为频繁地施加到被融合的椎骨水平(即下腰椎区的椎骨)上的沉重负荷及弯曲运动。 In addition, some of these devices are not structurally strong and can not be applied to withstand the most frequently fused vertebral levels (i.e., the lower lumbar vertebrae region) of the heavy loads and bending moments on. 需要提供一种既能优化骨生长能力又具有足够的强度,在形成关节固定之前能一直支承脊柱段的空心的体内融合装置。 Both to optimize desirable to provide a bone ingrowth capabilities but is still strong enough, the joint is formed prior to fixation has been able to support the spine segment of the hollow interbody fusion device. 本发明人已经发现,供骨生长的开口在防止应力保护嵌入在植入物中的自体骨方面起到了重要的作用。 The present inventors have found that, for the opening in the prevention of bone growth within the implant stress protection of autologous bone plays an important role. 换句话说,如果骨生长孔的尺寸或形状不合适,自体骨便不能承受某种负载,已经发现,这种负载是确保快速及完整的融合所必需的。 In other words, if the size or shape of the bone ingrowth openings inappropriate, the autologous bone will not endure the load, it has been found that such a load is to ensure rapid and complete fusion necessary. 在这种情况下,嵌入在植入物中的骨可能重新吸收或发展成简单的纤维组织,而不是骨融合体,这将导致结构总体上的不平衡。 In this case, embedded in the bone implant may resorb or evolve into simply fibrous tissue, rather than a bony fusion mass, which will lead to an imbalance in the overall structure. 另一方面,骨生长孔绝不能大到使壳体不具有足够的支承力、不能避免陷入到相邻椎骨中的程度。 On the other hand, the bone ingrowth openings must not be so great that the housing does not have sufficient supporting force can not avoid subsidence into the adjacent vertebrae.

上述已有装置没有解决的另一个问题涉及维持或恢复融合的脊柱段的正常解剖形态的问题。 Another problem with the above prior devices unresolved involved in maintaining or restoring the normal anatomy of the spinal fusion segment of the problem. 自然, 一旦把椎间盘取出,脊柱的正常的前凸或后凸弧度就消失了。 Naturally, once the disc is removed, normal lordosis or kyphosis curvature of the spine disappeared. 在己有装置中,对恢复这一弧度的 There are already in the apparatus, the need to restore this curvature

需求被忽略了。 Demand was ignored. 例如,Babgy的美国第4501269号专利为代表的, 如市售的、SpineTech的BAK装置中,相邻的椎骨体用装有特种植入物的圆柱形扩孔器扩孔。 For example, U.S. Patent No. 4,501,269 as represented Babgy, such as commercially available, the BAK device of SpineTech, adjacent vertebral bodies equipped with a cylindrical reamer reaming special implant. 在某些情况下,在扩孔之前先建立正常的弧度,然后再插入植入物。 In some cases, prior to reaming and normal curvature is established, and then the implant inserted. 图l示出了这种结构,图l显示了圆柱形的植入物插入到与安装植入物的盘内间隙相邻的基本上健康的椎骨中的深度。 Figure l shows this configuration, Figure l shows the depth of the cylindrical implant into the gap between the inner disc implant mounted substantially adjacent healthy vertebrae. 然而,由于取出了脊椎中的承重骨,又由于一般很难通过前凸最大的下腰段的后部扩孔,这种对后部过度扩孔的方法一般不被普遍接受。 However, since the removal of load bearing bone of the vertebrae, and because the reamer is generally difficult by the rear lower lumbar segment where the lordosis is greatest, which is generally not well accepted method of over-reaming of the rear portion. 在采用这种植入物的大多数情况下,不做恢复前凸弧度的努力,因此,随着椎骨稳定在植入物的周围,这种圆柱形的植入物容易引起后凸变形。 In most cases using implants, efforts to restore the lordotic curvature is not, therefore, as the vertebra settles around the implant material, the cylindrical implant is likely to cause a kyphotic deformity. 这种现象使脊柱失去平衡,因而常常导致重新进行手术。 This phenomenon makes the spine out of balance, and they often lead to revision surgery. 由于己有装置的这些缺陷,因此仍然需要有一种既能优化骨生长能力又能保持其强度和稳定性的体内融合装置。 Because of these drawbacks devices have been, there remains a need to have a capacity that can optimize bone ingrowth while still maintaining its strength and in vivo stability of the fusion device. 另外还需要使这种植入物能够维持或恢复安放植入物的区段的正常的脊柱解剖形态。 This also requires that the implant can maintain or restore normal spinal anatomy at the implant mounting section. 这种植入物必须具有足以支持并承受产生于处在安放植入物的水平上的脊椎上的沉重负荷的强度,同时在整个过程中应保持稳定。 Such an implant must be strong enough to support and withstand the heavy loads generated in the in the spine in a horizontal placement of the implant, while the whole process should be stable.

发明内容 SUMMARY

针对已有装置遗留下来的仍未解决的问题,本发明设计了一种空心的带螺纹的体内融合装置,可用于恢复相邻椎骨间的正常的角度关系。 For legacy of the prior devices is not resolved, the present invention contemplates a fusion device with a hollow threaded body can be used to restore the normal angular relation between adjacent vertebrae. 具体地说,该装置具有一个细长的主体,该主体大体上沿着其整个长度呈锥形,并且具有一个空心的内腔,该主体的外径大 Specifically, the device includes an elongated body that is generally tapered along its entire length, and having a hollow lumen, the outer diameter of the body

于相邻椎骨之间的间隙。 A gap between adjacent vertebrae. 该主体具有一个外表面,所述外表面具有一些相对设置的、成锥形的圆柱形部分和一对在上述圆柱形部分之间的相对设置的、成锥形的平的侧表面。 A body having an outer surface, said outer surface provided with opposite side surfaces and a tapered cylindrical portion between said cylindrical portion disposed opposite flat tapered pair. 因此,从一端看来,该融合装置就象是一个圆柱形的主体,该主体的侧面是沿着主体外径的弦被截成平面的。 Thus, from an end view, the fusion device gives the appearance of a cylindrical body, the side surface of the body is cut along a plane of the outer diameter of the string body. 在圆柱形的部分上开有螺纹,以便使该主体以受控的方式插入并接合到相邻椎骨的端板上。 Are threaded cylindrical portion, so that the body in a controlled insertion and engagement into the end plates of adjacent vertebrae.

在本发明的另一方面中,外表面沿其长度以一定的角度成锥形, 在一个实施例中,这一角度与下腰椎的正常的前凸角一致。 In another aspect of the present invention, the outer surface along its length is tapered at an angle, in one embodiment, this angle is consistent with the normal lordotic angle of lower lumbar vertebrae. 外表面上还具有一些在平的侧表面上形成的血管的开口,以及在圆柱形的部分上形成的一对相对设置的细长的骨生长槽。 The outer surface of the vessel also has openings formed on the flat side surfaces, and a pair of elongated opposite bone ingrowth slots formed on the cylindrical portion. 骨生长槽的横向宽度最好是在界定槽的范围内的圆柱形部分的有效宽度的一半左右。 Preferably the transverse width of the bone ingrowth slots are about half the effective width of the cylindrical portion of the range of the slots are defined.

本发明提供了一种用于将融合装置插入到盘内间隙中的驱动工具。 The present invention provides a method for inserting the fusion device into the disc drive tool gap. 在一个例子中,驱动工具包括一根轴,轴的一端具有一对彼此相对的成锥形的夹钳。 In one example, the drive means including a shaft end of the shaft opposite to each other with the tapered tongs couple. 这对夹钳借助一条铰合缝连接到轴上,所述铰合缝使夹钳张开以便将融合装置夹持在它们之间。 The tongs by means of a hinge slot is connected to the shaft, said hinge biases the tongs apart to receive a fusion device therebetween them. 驱动工具还具有一个围绕着所述的轴同轴设置的套筒,该套筒可以沿轴滑动,并挤压铰合缝,从而将这对夹钳往一起推,以便夹住融合装置。 The driving tool further has a shaft coaxially disposed around the sleeve, which sleeve can be slid along the shaft and compress the hinge seam, thereby to push the pair of tongs together to grip the fusion device. 或者, 可以采用一种内扩张弹性筒夹,在插入过程中从内部紧密地支撑住融合装置。 Alternatively, an elastomer can be used within the expansion collet, tightly during insertion prop fusion device.

在驱动工具的一个方面中,成锥形的夹钳具有一个外表面,该外表面的形状与融合装置的成锥形的圆柱形部分的形状相同。 In one aspect of the driving tool, the tapered tongs have an outer surface, the cylindrical portion of the same shape as the tapered shape of the outer surface of the fusion device. 夹钳还具有一个平的朝向内侧的、面向相应于融合装置的平的侧表面的表面。 Tongs also have a flat inward surface facing the respective flat side surfaces of the fusion device. 因此,当把夹钳压向融合装置时,夹钳的朝向内侧的表面与融合装置的平的侧表面接触,夹钳的外表面与融合装置结合成一个完整的圆锥形,以便于以拧入的方式将融合装置插入。 Thus, when the clamp is pressed against the fusion device, the flat side surfaces of the inwardly facing surface of the jaw in contact with the fusion device, the outer surface of the fusion device clamps combined into a complete conical, to facilitate screwing manner inserting the fusion device. 夹钳的朝向内侧的表面上还可以有几个凸出的部分,用以与融合装置中的孔接合,以便将该装置驱入并旋转到盘内间隙中。 The inward facing surface of the tongs may also be provided with projecting portion for fusion joining apparatus of the aperture, so that the drive means and rotation of the disk into the gap.

在本发明的另一方面中,提供了一种将融合装置植入到相邻椎骨之间的方法。 In another aspect of the present invention, there is provided a method of implanting the fusion device between adjacent vertebrae. 在一种方法中,是从前方插入,该方法包括扩张盘内间隙和在相邻椎骨的端板上钻出直径等于融合装置的螺纹内径的孔的步骤。 In one method, it is inserted from the front, the method comprising the step of the inner diameter of the threaded bore of the fusion device of dilating the disc space and drilling the diameter of the endplates of the adjacent vertebrae. 插入一个套筒,构成钻孔步骤和后面的植入融合装置步骤的工作通道。 A sleeve is inserted, constitute the drilling step and the following working channel implant step of the fusion device. 将植入物与驱动工具结合,插入到套筒中然后拧入到准备好的孔中。 The implant driving tool, inserted through the sleeve and threaded into the prepared bore. 锥形融合装置的插入深度决定了相邻椎骨达到的分开角度。 Depth of insertion of the tapered fusion device determines the amount of angular separation achieved adjacent vertebrae.

在另一种发明方法中,在后方预备插入点,即,从后方扩张盘内间隙,并在椎骨端板中钻一个内径孔。 In another method of the invention, behind the insertion site is prepared, i.e., a gap from the inner plate is dilated, the vertebral endplates and drilling a bore hole. 也用一个套筒来构成钻孔和插入步骤的工作通道。 A sleeve for the drilling and insertion steps to a working channel. 将融合装置插入到钻好的孔中,使其平的侧壁朝向相邻的椎骨。 The fusion device is inserted into the drilled hole, the flat side walls facing the adjacent vertebra. 然后旋转该装置,使位于其圆柱形部分上的外螺纹切入并啮合在相邻的椎骨上。 The device is then rotated so that external threads on the cylindrical portion cut into and engage the adjacent vertebrae. 此外,由于融合装置是锥形的, 该装置的锥形的外表面将使相邻的椎骨分开一定的角度,从而恢复正常的前凸解剖形态。 Further, since the fusion device is tapered, the tapered outer surface of the device would separate the adjacent vertebrae certain angle, thereby restoring normal lordosis anatomy. 附图说明 BRIEF DESCRIPTION

图1是已有技术中的融合装置的矢状面的侧视图; FIG. 1 is a side sagittal plane of the prior art fusion device;

图2是按照本发明的一个实施例的体内融合装置的放大透视 FIG 2 is an enlarged perspective view of the embodiment of the body fusion device according to an embodiment of the present invention.

图; Figure;

图3是沿3-3线剖取、沿箭头方向观看的图2所示的体内融合装置的侧剖视图; FIG 3 taken along line 3-3, of the apparatus body side shown in the arrow direction as viewed in FIG. 2 fusion cross-sectional view;

图4是图2所示的体内融合装置的前端的端面视图; FIG 4 is an end view of the distal end of the body shown in FIG. 2 fusion device;

图5是图2所示的体内融合装置的顶视图; FIG 5 is a top view of the interbody fusion device shown in FIG 2;

图6是从脊柱的前方观看时的AP侧视图,表示两个图2所示的体内融合装置被植入在位于L4与L5之间的体内间隙中时的情形; AP 6 is a side view of the spine viewed from the front, showing the situation when the device is implanted in vivo clearance between the L4 and L5 positioned in the body 2 shown in FIG two fusion;

图7是图6所示的植入在L4与L5之间的体内融合装置的矢状面的视图; FIG 7 is a view in the sagittal plane of the implant shown in FIG. 6 vivo L4 and L5 between the fusion device;

图8是按照本发明的体内融合装置的另一实施例的透视图; 图9是按照本发明的另一方面的植入驱动器的顶视图; 图10是植入驱动器的一端啮合在图2所示的体内融合装置上时的放大透视图; FIG 8 is a perspective view of another embodiment of an interbody fusion device of the present invention; FIG. 9 is another aspect of the present invention according to a top view of the implant driver; FIG. 10 is an end of the implant driver engaged in FIG. 2 It shows an enlarged perspective view of the interbody fusion device;

图11是图IO所示的啮合在体内融合装置上的植入驱动器的局部放大的侧剖视图; FIG 11 is a cross-sectional view IO engaging the implant driver locally on the interbody fusion device enlarged side;

图12是适合于与图IO所示的体内融合装置啮合的另一实施例 FIG 12 is shown in FIG IO adapted to interbody fusion device according to another embodiment of the engagement

的植入驱动器的局部放大的侧剖视图; The implant driver local enlarged sectional side view;

图13 (a) -13 (d)表示根据本发明的另一方面的植入体内融合 FIG 13 (a) -13 (d) represents the interbody fusion implant according to another aspect of the present invention.

装置(例如图2所示的装置)的方法的四个步骤; Four step process apparatus (e.g. apparatus shown in Figure 2) is;

图14 (a) -14 (d)表示植入体内融合装置(例如图2所示的装置)的另一种方法的四个步骤。 FIG 14 (a) -14 (d) represents the implanted fusion device (e.g., the device shown in FIG. 2) of the four steps of another method. 具体实施方式 detailed description

为了使本发明的原理得到更好的理解,下面将参照附图所示的几个实施例并采用具体的语言来描述本发明。 In order to make the principle of the invention be better understood, embodiments will now be described with reference to a few of the present invention shown in the drawings and specific language. 尽管如此,应当理解, 这并不意味着对本发明的范围的限定,本发明所属领域的技术人员将会很自然地预料到附图所示的装置的变化和进一步的改进,以及其中所包含的本发明的原理的进一步的应用。 Nevertheless, it should be understood that no limitation of the scope of the present invention, those skilled in the art of the present invention as would normally be expected to change in the device shown in the drawings and further modifications, and included therein further applications of the principles of the present invention.

图2-5示出根据本发明的一个方面的体内融合装置10。 2-5 show in vivo a fusion device 10 according to the aspect of the present invention. 该装置由一种坚硬的锥形主体11构成,主体11最好是由一种生物相容性的或惰性的材料制成。 The device formed by a solid conical body 11, body 11 is preferably made of a biocompatible or inert material. 例如,主体11可以由医用级的不锈钢或钛、 或其它具有适合于上述强度特性的合适的材料制成。 For example, the body 11 may be, or other suitable material having suitable strength characteristics to be made of medical grade stainless steel or titanium. 该装置也可由生物相容性的多孔材料,例如由Implex Corp提供的多孔钽制成。 The apparatus may also be of a biocompatible porous material, such as porous tantalum provided by Implex Corp. 为了便于参照,装置IO具有一个前端12和一个后端13,它们与装置10植入在盘内间隙中时的解剖位置相对应。 For ease of reference, IO device having a front end 12 and a rear end 13, 10 thereof with the device implanted within the anatomical location in the disc space corresponds. 锥形主体11界定了一个空心的内部15,内部15由主体壁16围成,并且其前端13由端壁17封闭(见图3)。 The conical body 11 defines a hollow interior 15 of the inner wall 15 surrounded by a body 16, and its front end 13 is closed by an end wall 17 (see FIG. 3). 空心的内部15被做成可以接纳自体移植骨或骨的替代物的形状,能够促进相邻椎骨之间以及整个盘内间隙中的坚固的融合。 The hollow interior 15 is made to be a shape to receive autograft bone or a bone substitute, as well as to promote a solid fusion between adjacent vertebrae across the disc gap.

根据本发明,体内融合装置10是一个带有螺纹的装置,能够拧入到相邻椎骨间的端板中。 According to the invention, the interbody fusion device 10 is a device with a threaded end can be screwed into the plate between adjacent vertebrae. 在本发明的一个实施例中,椎形主体ll 限定了一组间断的外螺纹18和一条位于该植入物的前端的完整的 In one embodiment of the present invention, the conical body ll defines a set of interrupted external threads 18 and a complete at the front end of the implant

螺纹19。 Thread 19. 完整的螺纹19充当将该植入物拧入到位于盘内间隙中的椎骨端板上的"起动"螺纹。 The complete thread 19 serves as the implant is screwed into the gap located within the vertebral endplates of the disc "start" thread. 螺纹18和19可以具有本领域中公知的几种形状,以便拧入到椎骨中。 Threads 18 and 19 may have well known in the art several shapes, for engagement into vertebral bone. 例如,这些螺纹可以具有三角形的横截面或截头三角形的横截面。 For example, the threads can have a triangular cross-section or a truncated triangular cross-section. 螺纹的高度最好是1.0mm(.039m),以便在椎骨中提供足够的啮合力,使融合装置10 不会被脊柱所受到的较高载荷推到盘内间隙之外。 The thread height is preferably 1.0mm (.039m), in order to provide sufficient engaging force in the vertebrae, the fusion device 10 is not subjected to the high loads of the spine are pushed out of the disc space. 在一些具体的实施例中,螺距是2.3mm(0.091in)或3.0mm(0.118m),这取决于将要植入的装置10的所在椎骨水平和将植入物保持定位所需的啮合螺纹的数量。 In some specific embodiments, the pitch is 2.3mm (0.091in) or 3.0mm (0.118m), depending upon the desired thread engagement device to be implanted in the vertebral level at which the implant 10 is held and positioned number.

在本发明的一个方面中,锥形主体ll,特别是主体的外壁16, 包括一对平行的平切的侧壁22,图4最清楚地示出了这一对平行侧壁22。 In one aspect of the present invention, the conical body ll, especially the outer wall 16 of the main body, comprising a pair of parallel truncated side walls 22, shown most clearly in FIG. 4 a pair of parallel side walls 22. 这对侧壁最好是平的,以便于将该融合装置插入到相邻椎骨的端板之间,并形成一个供骨融合的区域。 This side wall is preferably flat so as to be inserted into the fusion device between the end plates of adjacent vertebrae and provide area between for bony fusion. 这对平切的侧壁从装置的前端12—直延伸到位于后端13的完整的螺纹19。 This is a straight extension of the truncated side walls from the front end to complete the device 12- 19 at the rear end 13 of the screw. 这样,由于具有这对平切的侧壁22,装置10的端部呈不完整的圆形,这个圆形的两侧被沿着该圆的一条弦截去。 Thus, because of the truncated side walls 22, end of the device 10 is not completely circular shape, the circular sides are cut across a chord of the circle. 在一个具体的实施例中,体内融合装置IO的前端直径为16.0mm (0.630m)。 In a specific embodiment, the interbody fusion device IO tip diameter of 16.0mm (0.630m). 在这个具体的实施例中,平切的侧壁22是沿着一对大约相距12.0mm (0.472m)的平行弦线形成的,因此,在该装置的两侧被截去的圆弧部分大约与90。 In this particular embodiment, the truncated side walls 22 are formed along a pair of spaced approximately 12.0mm (0.472m) parallel strings, and therefore, both sides of the apparatus is cut off approximately arc portion 90. 的角相对。 The diagonally opposite. 本文将更详细地描述由融合装置10的平切的侧壁22带来的益处及优点。 Benefits and advantages will be described herein by the fusion device 10 of the truncated side walls 22 brought in detail.

装置10的锥形主体11包括一对通过各个平切的侧壁22确定的形成血管的开口24和25。 The conical body 11 of the apparatus 10 includes a pair of openings formed through the respective vessels 22 determines the truncated side walls 24 and 25. 当融合装置被植入到盘内间隙中时,开口24和25将沿着侧向排列或朝向矢状面。 When the fusion device is implanted within the intradiscal space, the openings 24 and 25 are arranged along the lateral or facing the sagittal plane. 这对开口将用于形成一条通路,以便能够在空心内腔15中的骨植入物与周围的组织之间形成血管。 This formed an opening for passage, so that blood vessels can be formed between the bone tissue around the implant in the hollow interior 15. 此外,有些骨还可能通过这些开口生长。 In addition, some bone ingrowth may also grow through these openings. 开口24和25的尺寸既能保证为形成血管提供最佳通路,又能保留在锥形主体11中的大量结构,以承受贯穿相邻椎骨间的盘内间隙的较大的轴向负荷。 Size of the opening 24 and 25 not only ensure optimum passage for blood vessels, while still retaining a large number of structures in the conical body 11 to support the high axial loads the intradiscal space between adjacent vertebrae through.

锥形主体11还确定了一些相对设置的骨生长槽27,所有这些槽都与平切的侧壁22成90°角。 The conical body 11 also defines a number of bone ingrowth slots 27 disposed opposite, all of the grooves are truncated side walls 22 and 90 ° angle. 当装置10被植入时,这些槽27 最好是直接与椎骨端板相邻。 When the device 10 is implanted, preferably these grooves 27 are directly adjacent the vertebral end plates. 更具体地说,当装置的螺纹18和19 被拧入到椎骨端板中时,椎骨将部分地延伸到槽27中与容纳在装置10的空心内腔15中的骨植入物接触。 More specifically, when the thread means 18 and 19 is screwed into the vertebral endplates, the vertebral extends partially into contact with the bone receiving the implant in the hollow interior 10 of the apparatus 15 of the groove 27. 图5更清楚地示出,为了确保完整的关节固定和坚实的脊柱融合,骨生长槽27被做成能为骨生长提供最大开口的形状。 Figure 5 shows more clearly, in order to ensure complete arthrodesis and a solid fusion, the bone ingrowth slots 27 are configured to provide maximum opening for the shape of bone growth. 这些槽的横向宽度最好是与主体的螺纹部分的有效宽度接近。 Lateral width of these grooves is preferably close to the effective width of the threaded portion of the body. 业己发现,采用许多小缝隙的已有装置不能促进骨质材料的快速及坚实的关节固定。 Industry has found that with many prior art devices of small apertures do not promote a rapid and solid fixed joint of the bone material. 这些小的缝隙反而还常常导致假关节的形成以及纤维组织的生长。 These small gaps but also often leads to the formation of false joints and growth of fibrous tissue. 由于本发明骨生长槽27直接面对着椎骨,它们不处于装置的必须承受较大负荷的部位上。 Since the 27 directly facing the vertebral bone ingrowth slots of the present invention, they are not in the device that must bear a greater portion of the load. 取而代之的是,平切的侧壁22将要承受借助于间断螺纹18通过椎骨的两个端板之间并且贯穿盘内间隙的大部分的负载。 Instead, the truncated side walls 22 will bear by means of the interrupted threads 18 and throughout most of the load within the disc space between two vertebrae endplates.

在进一步的特征中,在主体16的前端12上可以有一对沿径向相对的凹口29,这对凹口29的形状使得它们能与本文所述的植入驱动工具相配合。 In a further feature, on the front end 12 of the body 16 may have a pair of diametrically opposed recesses 29, the shape of this recess 29 is such that they engage an implant driver tool as described herein. 此外,在植入物的后端13的端壁17上也可以带有一个与工具配合的部件(未示出)。 Further, the rear end of the implant was in the end wall 17 of can 13 with a tool engagement member (not shown). 例如,如本文将进一步描述的那样,可以开一个六边形的凹槽来接纳一个六边形的驱动工具。 For example, as will be described further herein, it can be a hex recess to receive a hexagonal driving tool.

本发明的体内融合装置的一个重要特征是,主体11是成锥形或圆锥形的,换句话说,该装置的前端12的外径大于其后端13的外径。 An important feature of the present invention in vivo fusion device, the body 11 includes a tapered or conical, in other words, the outer diameter of the distal end of the apparatus 12 of the rear end 13 of its outer diameter. 如图3所示,主体壁16围绕着装置10的中线CL以角度A成锥形。 3, the body wall 16 about the centerline CL of the device 10. A tapered angle. 成锥形的主体壁16有助于恢复相邻椎骨之间的正常的相对角度。 Tapered body wall 16 to restore the normal relative angle between adjacent vertebrae. 例如,在腰部,角度A有助于恢复位于这个部位的脊柱的正常的前凸角度和弯曲度。 For example, the waist angle A helps to restore the normal lordotic angle and curvature of the spine in that region located. 在一个具体的例子中,角度A为8.794° 。 In a specific example, the angle A is 8.794 °. 不难理解,植入物可以具有一些非锥形的部分,只要这些部分不会影响锥形主体的功能即可。 It will be appreciated, the implant may have non-tapered portions, provided that the portions do not affect the function of the tapered can body.

植入物的锥角A与融合装置10的前端及后端的外径结合起来, 确定了当植入物被放入或拧入到它所处的位置中时将会在相邻椎骨之间形成的角发散的量。 The outer diameter of the front and rear ends 10 of the taper angle A of the implant with fusion device together, it will be determined between the adjacent vertebrae is formed when its location in the implant is placed or screwed into the amount of angular divergence. 图6和图7更清楚地示出了这一特征,这两幅图示出了采用一对融合装置IO的优选结构。 Figures 6 and 7 more clearly illustrates this feature, which illustrates two preferred configuration employing a pair of fusion devices IO. 在图示的结构中, 装置10被放置在下腰椎L4和L5之间,螺纹18和19拧入在两个椎骨的端板E中。 In the configuration shown, the apparatus 10 is placed between the lower lumbar vertebrae L4 and L5, threads 18 and 19 threaded into the two vertebral endplates E. 如图7所示,当装置IO被拧入端板E中时,它沿着箭头E的方向朝着椎骨水平的枢轴P前进。 As shown in FIG 7, when the IO device is screwed into the end plates E, it advances towards the pivot axis P of the vertebral level along the direction of arrow E. 枢轴P名义上是运动段的相邻椎骨之间的相对旋转的中心。 Pivot axis P is nominally the center of relative rotation between the adjacent vertebrae of the motion segment. 随着锥形融合装置10进一步沿着箭头I的方向朝着枢轴P前进,相邻椎骨L4和L5朝着箭头S的方向成角度地散开。 As the tapered fusion device 10 is further toward the pivot axis P in the direction of arrow I, and spread the adjacent vertebrae L4 and L5 at an angle toward the arrow S. 融合装置10的插入深度将决定相邻两椎骨之间达到的最终前凸角L。 Inserting the fusion device will determine the depth of the ultimate lordotic angle reaches between adjacent two of the vertebrae 10 L. 在装置10的几个具体实施例中,前端12的外径或螺纹牙顶的 In several specific embodiments of apparatus 10, the front end of the outer diameter or thread crest 12

直径可以是16、 18或20mm,装置的全长为26mm。 Diameter may be 16, 18 or 20mm, the entire length of the device is 26mm. 装置的尺寸由将要植入该装置的椎骨的水平和必须达到的角度决定。 Determined by the size of the device to be implanted and must reach the level of the angle of the vertebrae of the device.

在本发明的另一方面中,如图6所示,装置10的尺寸使得两个这样的圆柱形主体11可以被植入到一个盘间隙中。 In another aspect of the present invention, as shown in FIG. 6, the device 10 is sized so that two such cylindrical bodies 11 can be implanted into a single disc space. 这样就能在这两个装置10之间或周围放入另一种骨融合材料。 This allows the device 10 or between two additional bone graft into the surrounding material. 这一特性还促进了整个盘内间隙中的融合,并能将装置更坚实地固定到相邻的椎骨之间, 防止该装置被该特定的椎骨水平上的较高负荷挤出去。 This aspect further promotes fusion across the intradiscal space, and can more firmly secured to the device between adjacent vertebrae, preventing the device from being higher loads on the particular vertebral level.

在体内融合装置的一个具体实施例中,形成血管的开口24总体上呈矩形,其尺寸为6.0mm (0.236in)乘7.0mm (0.276in)。 In a fusion device vivo specific embodiment, the blood vessel opening 24 is formed generally rectangular, the dimensions of 6.0mm (0.236in) by 7.0mm (0.276in). 同样, 形成血管的开口25也呈矩形,其尺寸为4.0mm (0,157in)乘5.0mm (0.197m)。 Similarly, the vascularization opening 25 is rectangular, having dimensions of 4.0mm (0.157 in) by 5.0mm (0.197m). 自然,这一开口要小一些,因为它位于装置10的较小的后端13。 Naturally, this opening is smaller because it is located in the rear end 10 of the apparatus 13 is small. 骨生长槽27也是矩形的,其长为20.0mm (0.787m), 宽为6.0mm (0.236in)。 Bone ingrowth slots 27 are also rectangular in shape with a length of 20.0mm (0.787m), a width of 6.0mm (0.236in). 业已发现,形成血管的开口24、 25和槽27的这些尺寸对骨生长和血管形成是最佳的。 It has been found that the vascularization openings 24, 25 and grooves 27 of these dimensions on bone ingrowth and vascularization are preferred. 此外,这些开口的尺寸并不太大,它们兼顾了装置的结构整体性,或者它们使得容纳在空心内腔15中的骨融合材料在植入过程中能够较容易地被排出来。 Further, these openings are not so large that they compromise the structural integrity of the device or that they permit the bone housed in the hollow interior of the graft material 15 during the implantation process can be more easily discharged.

如图7所示,当装置被定位在L4和L5椎骨之间时,形成血管的开口24和25在侧面与椎骨周围的形成丰富血管的组织相接触。 As shown in FIG 7, when the device is positioned between the L4 and L5 vertebrae, the vascularization openings 24 and 25 in contact with the highly vascularized tissue surrounding the vertebrae form side. 并且,如图6所示,骨生长槽27朝向轴向,因此与椎骨端板E接触。 As shown in FIG 6, the bone ingrowth slots 27 are axially directed so that the contact with the vertebral end plates E.

在图8所示的本发明的另一实施例中,体内融合装置30由一个锥形的主体31构成。 In another embodiment of the invention shown in FIG. 8 embodiment, the interbody fusion device 30 is constituted by a conical body 31. 和前面的实施例中的融合装置10—样,主体34限定了一个空心内腔33。 And fusion to the preceding embodiments 10-like body 34 defines a hollow interior 33. 但是,在这个实施例中,平切的侧壁38上不带有形成血管的开口。 However, in this embodiment, the truncated side walls 38 with no vascularization opening. 并且,位于装置10的相对两侧的骨 And, it means located at opposite sides of the bone 10

生长槽34比较小。 Growth groove 34 is relatively small. 这意味着位于装置30的外部的间断螺纹36围绕着植入物延伸更长的一段距离。 This means that the interrupted threads 30 located outside of the apparatus 36 surrounds the implant extending a distance longer. 如果采用多孔材料(例如钽)来形成供组织生长及固定到相邻骨上的辅助表面,则可以采用这样的设计。 If formed using a porous material (e.g., tantalum) for tissue ingrowth and anchorage to the adjacent bone surface of the secondary, so that the design can be employed. 图8所示的实施例的体内融合装置30还可以应用于某些椎骨水平,在这些水平上,装置被挤出去的风险最大。 Interbody fusion device 30 shown in FIG. 8 embodiment may also be applied to certain vertebral levels, at these levels, the maximum risk of expulsion means. 因此,通过增加螺纹的接触量来防止发生这类的挤出。 Thus, by increasing the amount of contact with the thread to prevent such extrusion to occur. 在插入之前,先在装置10的空心内腔15中填满骨或替代物,以便为这样的预加载提供方便。 Prior to insertion, or bone substitute to fill in the hollow interior 10 of the apparatus 15, in order to facilitate this pre-loading.

根据本发明的一个方面,可以利用图9所示的植入驱动器50 将体内融合装置10植入体内。 According to one aspect of the invention, the interbody fusion device 50 10 can be implanted using the implant driver shown in Figure 9. 植入驱动器50由一个轴51和一个围绕着该轴同心设置的轴套52构成。 The implant driver 50 is constituted by a shaft 51 and a sleeve 52 surrounding the shaft concentrically arranged. 轴的一端带有一些夹钳54,用于夹持体内融合装置10以便将其植入。 Tongs end of the shaft 54, for gripping the interbody fusion device 10 so as to be implanted. 夹钳具有一个成锥形的外表面55和一个平的内表面56,适合于与体内融合装置的平切的侧壁22配合。 The clamp having a tapered outer surface 55 and a flat inner surface 56 adapted to engage the interbody fusion device 22 with the truncated side walls. 锥形的外表面55与间断螺纹18的根径一致,因此夹钳54 基本上填满主体壁16的整个圆柱形状。 Tapered outer surface 55 and the thread root diameter consistent discontinuity 18, the clamp 54 thus substantially fills the entire body wall 16 of a cylindrical shape. 由于外表面55将跨接在位于椎骨端板内的开了螺纹的孔中,所以夹钳的锥形外表面55促进了体内融合装置IO的拧入。 Since the outer surface 55 will be positioned across the vertebral end plates of the open threaded bore, the tapered outer surface so that the clamp 55 is screwed into the body to promote fusion of the IO device.

每个夹钳都带有从内表面56伸出的联锁销58和驱动凸块59。 Each of the tongs with the inner surface 56 extending from the interlock pin 58 and the drive lug 59. 图11更清楚地示出了这些部件的功能。 Figure 11 more clearly shows the functions of these components. 先看图9,轴51上带有一个支撑一对夹钳54的铰合缝62。 First to Figure 9, the shaft 51 with a hinge 54 supporting a pair of jaws 62 commissure. 铰合缝62具有这样的形状:它使夹钳处在一个分散得足够开的自然偏斜的状态,能够将锥形体内融合装置10接纳在夹钳之间。 Hinge slot 62 has such a shape: it makes the gripper in a state dispersed sufficiently apart skewed nature, it can be tapered interbody fusion device 10 received between the clamp. 轴51限定了一个位于铰合缝62和各夹钳54之间的锥形部分63。 The shaft 51 defines a tapered between the hinged slot 62 and each of the tongs 54. 63. 这个锥形部分与位于轴套52的内壁上的锥形槽67匹配。 The tapered portion 52 of the sleeve located on the inner wall of the tapered slot 67 match. 因此,当便轴套52朝着夹钳54的方向前移时,锥形槽67倚靠着锥形部分63,从而封闭或压挤铰合缝62。 Thus, when the sleeve 52 will be advanced toward the tongs 54, the conical chamfer 67 rides against the conical taper 63 to close or compress the hinge slot 62. 以这样的方式,夹钳54受到使它们彼此靠近的推力,并且在压力的作用下将位于两夹钳之间的体内融合装置夹紧。 In this manner, the tongs 54 are close to each other that they are thrust under pressure and interbody fusion device will be located between the clamping tongs.

轴51和轴套52具有带螺纹的界面65,使轴套52能够沿轴的长度方向拧到轴上或从轴上拧下。 Shaft 51 and sleeve 52 having a threaded interface 65 which permits the sleeve 52 can be screwed onto the shaft or the longitudinal direction of the shaft from the shaft unscrewing. 具体地说,带螺纹的界面65包括位于轴51上的外螺纹和位于轴套52上的内螺纹,所述内、外螺纹具有相同的螺距,因此轴套可以方便地从植入驱动器上移上移下。 Specifically, threaded interface 65 includes external threads on the shaft 51 and internal threads on the sleeve 52, the inner and outer threads with the same pitch, and therefore the sleeve can be easily removed from the implant driver move down. 轴51还带有一对止动销69,它们将轴套52的后移限制在一个范围内,这个范围仅仅是为了接纳体内融合装置10而使夹钳54独立出一段足够的距离所需的移动范围。 Further shaft 51 with a pair of stopper pins 69, after which the sleeve 52 is shifted within a restricted range, this range is only 10 to receive the interbody fusion device of the jaw 54 to separate the desired range of movement a sufficient distance .

图IO和11示出了植入驱动器的使用过程。 FIG IO and 11 illustrate use of the implant driver. 如图IO所示,夹钳54的外表面55处在基本上与间断螺纹18的根径平接的位置上。 FIG IO, the outer surface 55 of the clamp 54 is in substantially the root diameter of the interrupted threads 18 contact the flat position. 如图11所示,可以将两个止动销58安置到位于各平切的侧壁22上的形成血管的开口24中。 11 may be disposed two stop pins 58 into the opening 24 formed in the blood vessel is located on each of the truncated side walls 22. 以同样的方式,驱动凸块59与位于锥形主体ll的前端12上的容纳驱动工具的凹口29啮合。 In the same way, drive cam 5929 engaged with the distal end of the tapered body ll driving tool receiving recess 12 on. 联锁销58和驱动凸块59相结合,将体内融合装置IO紧紧地夹持住,从而可以将该装置拧入到位于脊椎骨中的攻了丝的或未攻丝的开口中。 Interlock pin 58 and the driving projection 59 in combination, the interbody fusion device IO tightly clamped, so that the device can be screwed into the tapped or untapped opening of filaments located in the vertebra attack.

图12示出了植入驱动器的另一实施例。 FIG 12 shows another embodiment of the implant driver. 驱动器90包括一个轴91,其长度足以保证其从病人体外伸至盘内间隙中。 90 comprises a drive shaft 91, from which a length sufficient to reach into the intradiscal space in a patient in vitro. 一个限定了一对彼此相对的夹钳93的头部与轴91的端部相连,各夹钳的形状使得它们能够与融合装置10的平的平切的侧壁22平接。 Defines a pair of opposed jaws 93 and the head end portion of shaft 91 connected to each other, the shape of each jaw such that they can be fusion apparatus 10 of the flat truncated side walls 22 butt. 与前面所述的植入驱动器50的两个夹钳54 —样,夹钳53的外表面呈圆柱形,以便与装置的圆柱形螺纹部分一致。 , To conform to the cylindrical threaded portion of the device of the like, the outer surface is cylindrical clamp 53 - two tongs 54 and 50 of the previously described implant driver.

与植入驱动器50不同,图12所示的实施例中的驱动器90利用 Unlike the implant driver 50, the embodiment shown in FIG. 12 using drive 90

-一个可扩张的弹性筒夹组件来紧紧地卡持住融合装置10以便将其插入到身体中。 - an expandable collet assembly to firmly grip the fusion device 10 so as to be inserted into the body. 具体地说,头部92限定了一个弹性筒夹94,弹性筒夹94具有一个贯穿于其中的中心套孔95。 Specifically, the head 92 defines a collet 94, collet 94 having a central collet bore 95 therein. 弹性筒夹94的一端是一个环形凸缘96,环形凸缘96至少在最初具有稍小于融合装置10 的端部12的内径的直径。 Collet 94 is an annular end flange 96, annular flange 96 having a diameter of an inner diameter slightly smaller than the end portion 12 of the fusion device 10 at least initially. 一根扩管轴97以可滑动的方式贯穿所述的套孔,并且带有一个加大的端部98,端部98靠近环形凸缘96并且刚刚伸至环形凸缘96之外。 An expander shaft 97 slidably in the through hole of the sleeve, and with 98, an end portion of an enlarged end portion 98 near the annular flange 96 and extends to just beyond the annular flange 96. 扩管轴97的加大的端部98在其起始端的直径较少,使其能够在套孔95中滑动,从该起始端开始,端部98的直径逐渐加大至大于所述套孔的直径。 Expander shaft end portion 97 of enlarged diameter at its starting end 98 is less, so that it can slide in the bore 95, starting from the starting end, the diameter of the end portion 98 is gradually increased to greater than the trepanning diameter of.

植入驱动器90包括一个拆卸工具轴99,所述的轴99以可以滑动的方式设置在由轴91限定的孔100中。 The implant driver 90 includes a puller shaft 99, the shaft 99 is slidably disposed in a bore 91 defined by the shaft 100. 在拆卸工具轴99的端部有一个与扩管轴97的端部上的锁定毂102接合的锁定腔101 。 At the end of the removal tool has a shaft 99 with the expander shaft locking cavity 101 of the hub 102 engages the upper end portion 97. 拆卸工具轴99伸至轴91的端外,供外科医生持握。 Removal tool shaft 99 extends to the end of the outer shaft 91, for gripping the surgeon. 当把拆卸工具轴99 拉出时,它便将扩管轴97从套筒94的环形凸缘96中向外拉,从而使加宽的端部98逐渐地接合在套孔95中。 When the puller shaft 99 is pulled, which put the expander shaft 97 from the annular flange 94 of the sleeve 96 pulled outward, so that the flared tip 98 becomes progressively engaged within the collet bore 95. 随着端部98进一步前移至套孔95中,环形凸缘97从初始直径扩大至一个更大的第二直径, 足以紧紧地卡持住融合装置10的内腔。 As the end portion 98 is further moved to the front of the bore 95, the annular flange 97 expanded from an initial diameter to a larger second diameter sufficient for firm gripping contact with the lumen 10 of the fusion device. 通过使植入驱动器以这种方式与融合装置接合,可以将装置IO插入至手术区中,然后,可将扩孔轴推至套孔之外以释放加大端,从而将融合装置松脱开。 By this way the implant driver engaging the interbody fusion device IO device may be inserted into the surgical site, and may be outside the shaft reamer collet bore to release the flared tip and, consequently, the fusion device release opening .

本发明设计了两种植入体内融合装置10的方法。 The present invention contemplates two methods for implanting the interbody fusion device 10. 首先,图13 (a) -13 (d)示出了前方插入法。 First, FIG. 13 (a) -13 (d), an anterior approach is shown. 在预备步骤中,需要定下植入融合装置的合适的、最好是双侧的起点。 In a preliminary step, it is necessary for implanting the fusion device suitable, preferably the starting point is two-sided. 在这前方插入法的第一步中, In this first step of an anterior approach,

先将一个扩张器75放置到椎骨的两个端板E之间以扩张L4和L5 Between a dilator 75 placed into the vertebral endplates E to dilate the L4 and L5

之间的盘间隙。 The gap between the disc. (当然,应该理解,这一步骤也可用于其它的椎骨 (Of course, it should be understood that this step may also be used in other vertebrae

水平)。 Level). 在图13 (b)所示的第二步骤中,将一个套筒76放置到盘间隙周围。 In FIG 13 (b) a second step shown in an outer sleeve 76 is disposed about the disc space. 可以按公知的方法设计套筒76的形状,使其能够与椎骨主体的前部可靠地接合,以便牢固地、但又是暂时地使套筒76定位。 It may be a known method according to the shape of the sleeve 76 is designed so that it can be reliably engaged with the front portion of the vertebral body, in order to firmly, but temporarily, the sleeve 76 is positioned. 实质上,在这种腹腔镜(laproscopic)式的植入法中,套筒76起的是一个工作通道的作用。 In essence, such a laparoscope (laproscopic) implantation in the formula, the outer sleeve 76 operates as a working channel. 在图13 (b)所示的这个步骤中,将一个公知的钻头77插到套筒中,用该钻头在这两个相邻的椎骨中钻出孔。 In FIG 13 (b) shown in this step, a drill 77 of known outer sleeve and used to drill out circular openings in the adjacent vertebral bodies. 也可以在这些孔中攻丝,以便于将融合装置拧入,尽管这一步骤并不是必不可少的。 It may also be tapped in the holes, to facilitate screwing the fusion device, although this step is not necessary.

在图13 (c)所示的下一个步骤中,用植入驱动器50夹持住融合装置IO,并将其插至套筒76中,直到起动螺纹19接触到骨上的开口。 In the next step shown in FIG. 13 (c), the holder 50 with the fusion device implanted in the IO driver, and insert it into the sleeve 76 until the starter thread 19 contacts the bone opening. 然后,可以用植入驱动器50将融合装置IO拧入到开在椎骨端板中的攻了丝的或未攻丝的孔中。 Then, the implant driver 50 can be screwed into the fusion device IO apart vertebral end plate tapping or tapping holes in the filaments. 应该理解,在这个步骤中,也可以利用其它合适的驱动工具,如螺纹驱动器型的装置,与位于装置10的前端12的驱动工具凹槽29接合。 It should be understood that in this step, may be utilized other suitable drive means, such as a screw driver type device, the distal end 29 engages the groove 12 of the driving tool 10 is positioned with the device. 如前面所述,融合装置10的插入程度决定了加在这个脊椎水平上的、或者是使这个脊椎水平恢复的脊柱前凸的量。 As described above, the degree of insertion of the fusion device 10 determines the increase in this level of the spine, the spine or that the level of recovery of the amount of lordosis. 在最后的步骤中,将植入驱动器取出,使融合装置10留在原位。 In the final step, the implant driver is removed leaving the fusion device 10 in position. 可见, 一旦被植入,封闭的端壁17便朝向该椎骨的后端。 Be seen that once implanted, the closed end wall 17 is toward the rear of the vertebrae. 位于前端的空心内腔15是敞开的,但必要的话可以用金属或塑料材料将其封闭住。 At the front end of the hollow interior 15 is open, but if necessary, with a metal or plastic material which is closed by.

在第二种发明方法中,图14 (a) -14 (d)示出了后方插入法。 In a second method of the invention, FIG. 14 (a) -14 (d) shows a posterior approach. 后方插入法的前面两个步骤与前方插入法相似,不同的只是,扩张 The first two steps of the posterior approach, an anterior approach is similar, but different, the expansion

器75、套筒76和钻头77是从后面放入安放植入物的区域中的。 75, the sleeve 76 and drill 77 are introduced posteriorly into the instrumented region of the implant. 这种插入法可能需要将椎骨剥离或移开以便接纳套筒76。 This approach may require decortication and removal of vertebral bone to receive the sleeve 76. 在该方法的第三步中,将融合装置10通过套筒76插入到扩张的盘间隙中。 In the third step of the method, the fusion device 10 is inserted into the dilated disc space through the sleeve 76. 应该理解,只需将盘间隙扩张到一定的程度,这一程度是接纳具有直接面对椎骨端板E的平切的侧壁22的植入物所必须的。 It should be appreciated that disc space is dilated only to a certain extent, the extent having a receiving directly facing the vertebral end plates E of the truncated side walls 22 of the implant is necessary. 因此,如图14 (c)所示,骨生长槽27朝向侧向,而不是朝向横向,与其预期的植入位置一致。 Thus, FIG. 14 (c), the bone ingrowth slots 27 toward the side, rather than the transverse direction, consistent with its intended implant location. 可以利用一种合适的驱动工具80使融合装置10 通过套筒76伸出,并进入到盘内间隙中。 You may utilize a suitable driving tool 80 of the fusion device 10 through the outer sleeve 76 and into the intradiscal space. 在一个实施例中,驱动工具80带有一个凸出部81,其形状与开在融合装置10的后端13的端壁17上的凹口吻合。 In one embodiment, the driving tool 80 includes a projection 81, which is open in the shape of the recess 17 on the rear end wall 13 of the fusion device 10 coincide. 也可以利用外螺纹(未示出)将装置10固定到驱动器80上。 You can also use an external thread (not shown) of the device 10 to the drive 80.

一旦将融合装置10推入盘内间隙中并相对于椎骨的枢轴P到达了合适的深度,就可利用驱动工具80沿图14 (c)中箭头R所指的方向转动该植入物。 Once the fusion device 10 is pushed into the disc space and vertebrae with respect to the pivot axis P reaches the appropriate depth, you can use the driving tool 80 in FIG 14 (c) in a direction indicated by arrow R of rotation of the implant. 随着驱动工具80的旋转,装置本身也旋转, 使间断螺纹18开始切入到位于端板E处的椎骨中。 As the driving tool 80 is rotated, the device itself rotates so that the interrupted threads 18 start cutting into the end plate E of the vertebrae. 以这样的方式, 植入物象一个凸轮一样沿着沿图14 (c)中箭头S所指的分散方向将相邻的椎骨分开。 In this manner a separate, physical image implanted in a direction of the cam as dispersion (c) of the adjacent arrow S indicated in FIG. 14 along the vertebrae. 由于只需一次旋转就可将植入物锁定到椎骨中, 所以,这种凸轮式插入从某种程度上说是一种较为简便的插入方法。 Since the single rotation is required to lock the implant into the vertebral bone, the cam is inserted to some extent a more simple insertion method. 相反,前面讨论的螺纹式插入技术需要将装置连续地拧入至其位置上。 In contrast, screw-insertion technique discussed above requires a device which is continuously screwed into position.

采用这两种技术中的任何一种,都可以利用X-射线或其它合适的技术来检验融合装置10相对于与之相邻的椎骨的位置,从而建立椎骨之间的角度关系。 Using either of these techniques, you can make use of X- rays or other suitable technique to verify the position of the device 10 with respect to the adjacent vertebrae fusion, thereby establishing the angular relationship between the vertebrae. 或者,可以预先确定优选的植入物插入深度, 并且在将植入物放入椎骨之间时从病人体外测定这一深度。 Alternatively, the pre-determine the preferred implant insertion depth, and the depth of the implant measured from outside the patient was placed between the vertebrae time.

可见,本发明的体内融合装置10、植入驱动器50以及本发明的方法比已有的装置和技术具有显著的优点。 It is seen that the interbody fusion device 10 of the present invention, the implant driver 50 and advantages of the method of the present invention has a significantly over the prior devices and techniques. 具体地说,融合装置10是一个带螺纹的空心插入物,最大限度地挖掘了相邻椎骨间的骨融合潜能,同时保持了植入物本身的整体性。 Specifically, the fusion device 10 with a hollow threaded implant that maximizes the potential for bony fusion excavated between adjacent vertebrae, while maintaining the integrity of the implant itself. 应该理解,脊柱在其轴向上要承受相当大的负荷,至少在达到坚实的融合之前,这种负荷都必须由融合装置IO来承受。 It should be understood that the spine endures significant axial load, at least until solid fusion is reached, the load must be supported by the fusion device IO. 装置IO还带有供血管形成及组织生长的部件,这些部件加速了融合的速度,提高了融合成的骨质的强度。 IO device further having means for vascularization and tissue ingrowth to occur which speeds up the fusion of the parts, the strength of the resulting fused bony mass. 另一个显著的方面是,植入物的锥形形状使外科医生能够恢复和维持椎骨体之间的合适的弧度或相对的角度。 Another significant aspect is that the tapered shape of the implant allows the surgeon to restore and maintain the proper curvature or relative angle between vertebral bodies. 这就可以避免出现产品变形、脊柱失去平衡这类的与己有装置有关的严重问题。 This can avoid deformation of the product, the spine out of balance with this kind have had serious questions about the device. 本发明的装置及植入驱动器的另一个优点是,利用一种腹腔镜式的插入方法既可以从前部也可以从后部将其插入。 Another advantage of the device and its implant driver according to the present invention is used a method for laparoscopic insertion either anteriorly or posteriorly inserted. 根据椎骨水平,两种插入方法都是可取的,因此,重要的是,植入物要适合于从这两个方向插入。 Depending upon the vertebral level, either approach may be preferred, therefore, important that the implant be adapted for insertion from either direction. 在前方插入法中,利用旋入技术(与敲入相对照)来控制装置的插入,在后方插入法中,用滑入及凸轮式的方法来控制装置的插入。 In an anterior approach, the use of screw-in technique (vs. pounding in) to control the insertion device, behind the insertion method, the slide-in and cam method used to control the insertion device.

尽管已经利用附图和前面的描述展示并阐述了本发明,但这些附图和描述仅仅是说明性的而不是限定性的,应当理解,前面只是显示并描述了优选的实施例,落入本发明的构思范围的所有变化和 Although the drawings and foregoing description of the present invention is shown and described, these drawings and description are illustrative only and not limiting, it will be understood that the foregoing is only shown and described preferred embodiments, fall within the All changes spirit and scope of the invention

改进都应当受到保护。 Improvements should be protected. 例如,尽管只是公开了装置io用于脊柱的情 For example, although only discloses apparatus for spinal situation io

况,但本发明的结构和方法还可用于其它关节间隙中,例如踝关节、腕关节和subtalar关节。 Conditions, but the structure and method of the present invention can be used in other joint spaces, such as the ankle, wrist and subtalar joints. 此外,尽管在优选实施例中显示的装置10 在其整个长度范围内都是锥形的,但是在所得到的装置上加上非锥形的或者倒锥形的部分仍然落入本发明的范围。 In addition, 10 in the tapered along its entire length of display device in the preferred embodiment although the embodiment, but with non-tapered or reverse tapered section can still fall within the scope of the present invention is obtained in the device .

Claims (8)

  1. 1. 一种驱动工具,用于将体内融合装置植入到相邻椎骨之间的间隙中,所述的融合装置具有一个主体,所述的主体具有一个被相对设置的平直侧壁断开的圆柱形外表面,所述的外表面上带有外螺纹,所述的驱动工具包括: 一个细长的轴;以及一对通过铰接件与所述轴的一端连接的、彼此相对的夹钳,所述的夹钳彼此偏离开; 所述夹钳中的每一个都具有一对被成形得能够与融合装置的相对设置的平直侧壁接触的向内的表面和一对被成形得能够与融合装置的圆柱形外表面相一致的向外的表面。 A driving tool for implanting the interbody fusion device into a gap between the adjacent vertebrae, the fusion device having a body, said body having opposite flat side walls being disposed off the cylindrical outer surface, said outer surface having external threads, said drive means comprising: an elongated shaft; and, one pair of opposite tongs connected to one another by a hinge at one end of said shaft , biasing said tongs away from each other; each of the jaws having a pair of inwardly facing surface shaped to be capable of contacting with the opposite flat side walls of the fusion device and can be shaped to a pair of coinciding with the cylindrical outer surface of the fusion device outward surface.
  2. 2. 如权利要求1所述的驱动工具,其中的融合装置带有开在平直的侧表面上的开口,其中,每个所述的夹钳的所述向内的表面都带有一个从该表面伸出的销子,当所述的向内表面与所述的平直侧表面接触时,所述的销子将伸入到融合装置的平直侧表面上的多个开口之一中。 2. The driving tool according to claim 1, wherein the fusion device with a flat opening on the side surface of the opening, wherein the inner surface of each of said clamps are provided with a from the surface of the projecting pin, when in contact with the inward surface of the flat side surface, said pin extending into one of the plurality of openings on a flat side surface of the fusion device .
  3. 3. 如权利要求1所述的驱动工具,其特征在于,所述驱动工具还包括一个围绕着所述轴同轴地设置的轴套,所述的轴套可以在所述的轴上滑动,从而挤压所述的铰接件,以便将所述的夹钳彼此推近,由此,所述的夹钳将位于所述夹钳之间的融合装置夹紧。 The driving tool according to claim 1, characterized in that the driving tool further comprises a sleeve disposed coaxially around the shaft, the sleeve slidable on said shaft, so as to press said hinge member, so as to push said tongs close to each other, whereby said clamp means located between the fusion clamping jaw.
  4. 4. 如权利要求3所述的驱动工具,其特征在于,所述的轴套借助于螺纹接合在所述的轴上,因此,当使所述的轴套围绕着螺纹接合处旋转时,所述的轴套会沿着所述轴的长度方向轴向地移动。 The driving tool according to claim 3, wherein said sleeve by means of a threaded engagement of the shaft, and therefore, when the sleeve rotates about the threaded joint, the said sleeve is moved axially along the longitudinal direction of the shaft.
  5. 5. 如权利要求3所述的驱动工具,其特征在于:所述的夹钳带有一个与所述铰接件相邻的锥形表面;并且在所述轴套的内表面上有一个锥形的槽,所述的锥形的槽与所述的锥形表面互补,因此,当所述的轴套朝着所述的夹钳轴向移动以挤压所述的铰接件时,所述的锥形槽也随之沿着所述的锥形表面移动。 The driving tool according to claim 3, wherein: said tongs having a hinge member adjacent said tapered surface; and a tapered inner surface of the sleeve slot, said tapered slot tapered surface complementary to said, therefore, when the axial movement of said sleeve toward said tongs to squeeze said hinge, said taper also moved along the tapered surface.
  6. 6. 如权利要求1所述的驱动工具,其中所述的融合装置具有一对开在其一端中的相对设置的凹口,其中,所述的夹钳带有一些从所述的向内表面伸出来的驱动凸块,所述的驱动凸块可以和融合装置中的相对设置的凹口啮合。 6. The driving tool according to claim 1, wherein said fusion device having a recess at one end thereof outside of oppositely disposed, wherein said tongs include a number of inwardly from said surface projecting to the drive lug, said drive lugs and recesses can be disposed opposite the engagement means of fusion.
  7. 7. —种驱动工具,用于将体内融合装置植入到相邻椎骨之间的间隙中,所述的融合装置是空心的,该融合装置具有一个主体,所述的主体具有一个圆柱形内表面和一个被相对设置的平直侧壁断开的圆柱形外表面,所述的外表面上带有外螺纹,所述的驱动工具包括:一个细长的轴;以及一对与所述轴的一端连接的、彼此相对的夹钳,所述的夹钳彼此偏离开以便将融合装置的相对设置的平直侧壁接纳在它们之间;以及一个与所述的细长的轴相连的可扩张的弹性筒夹组件,所述的可扩张的弹性筒夹组件具有这样一个部分,该部分能够从一个小到使其可以置身于该空心的融合装置的内腔中的第一直径扩大到一个较大的、使其能够卡持住融合装置的内腔的第二直径。 7. - kind of driving tool for implanting the interbody fusion device into the gaps between adjacent vertebrae, the fusion device is hollow, the fusion device having a body, said body having a cylindrical inner disconnect the cylindrical outer surface and the surface opposite flat side walls is disposed, the externally threaded outer surface, said drive means comprising: an elongated shaft; and a pair of said shaft connected to one end of the opposed jaws to each other, the tongs away from each other so as to bias the opposite flat side walls of the fusion device receiving therebetween; a and a shaft connected to said elongate first diameter expansion collet assembly, said expandable collet assembly has a portion which may be capable of being in the lumen of the hollow fusion device from a small to expand it to a large, it is possible to catch a second lumen diameter live fusion device.
  8. 8.如权利要求7所述的驱动工具,其特征在于所述的可扩张的弹性筒夹组件包括:一个与所述的一对相对的夹钳成为一体的头部,所述的头部具有一个贯穿于其中的中心孔和一个位于所述中心孔的一端的与所述的夹钳相邻并位于所述夹钳内侧的环形凸缘;以及一个以可滑动的方式设置在所述的中心孔之中的扩管轴, 所述的扩管轴具有一个端部,当所述的扩管轴被放置在所述的中心孔中时,该端部从一个小到使其能够在所述的中心孔中滑动的第一直径扩大到一个与所述的环形凸缘相邻的较大的第二直径,由此,当所述的扩管轴縮入到所述的中心孔中时,所述的扩大的端部使所述的环形凸缘逐渐地扩张到与融合装置的内腔啮合的程度。 8. The driving tool according to claim 7, wherein said expandable collet assembly comprising: a pair of said opposed tongs integral head, said head having and a through-hole in a center of said central aperture at one end with said annular flange and located adjacent the clamp of the clamp inside therein; and a slidably disposed in said center expander shaft in the bore, said expander shaft having an end, when said expander shaft is disposed in the center hole, the end portion from a small to enable it in the the diameter of the central bore of the first slide extends to a larger second diameter adjacent said annular flange, whereby when said expander shaft is retracted into said central bore, the the enlarged end portion of said annular flange is gradually expanded to the degree of engagement with the lumen of the fusion device.
CN 200410028616 1995-03-27 1996-03-26 Methods and instruments for interbody fusion CN100425214C (en)

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US08411017 US5782919A (en) 1995-03-27 1995-03-27 Interbody fusion device and method for restoration of normal spinal anatomy
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CN96105961.3 1996-03-26

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