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Publication numberCN100425214 C
Publication typeGrant
Application numberCN 200410028616
Publication date15 Oct 2008
Filing date26 Mar 1996
Priority date27 Mar 1995
Also published asCN1701772A
Publication number200410028616.6, CN 100425214 C, CN 100425214C, CN 200410028616, CN-C-100425214, CN100425214 C, CN100425214C, CN200410028616, CN200410028616.6
InventorsEF雷三世, LM博伊德, TA兹德布里克
ApplicantSdgi集团有限公司
Export CitationBiBTeX, EndNote, RefMan
External Links: SIPO, Espacenet
Methods and instruments for interbody fusion
CN 100425214 C
Abstract  translated from Chinese
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 wall is disposed opposite the cylindrical disconnect shaped outer surface, said outer surface having external threads, said tool comprising: an elongated shaft; and a pair of connection through the hinge end of said shaft, opposite to each other clamp, the clamp offset from each other; the jaws of each have been formed to be able to come into contact with the side wall of the fusion device oppositely disposed flat inwardly facing surface and a pair of a pair can be shaped to the fusion device The outer surface of the cylindrical outer surface of the same.
Claims(8)  translated from Chinese
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 an opposing flat side walls disposed off The cylindrical outer surface, said outer surface having external threads, said driving tool comprising: an elongated shaft; and a pair of connection through the hinge end of said shaft, opposite to each other tongs said clamp offset from each other; the jaws of each have been formed to be able to come into contact with the side wall of the fusion device flat oppositely disposed inwardly directed surfaces of a pair and a pair of forming was able consistent with the cylindrical outer surface of the fusion device outward surface.
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 an open side on a flat surface of the opening, wherein the surface of each of said inwardly are provided with a clamp from The surface of the projecting pin, when in contact with said inner surface of said flat side surface, said pin extends into one of the plurality of openings on a flat side surface of the fusion device .
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。 3. The driving tool according to claim 1, wherein said drive means further comprises a sleeve disposed coaxially around said shaft, said sleeve slidable on said shaft, thereby pressing said hinge to push said tongs near each other, whereby said clamp means located at the fusion between the clamping jaws.
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, characterized in that said threaded engagement means of the sleeve in the shaft so that when said sleeve rotating around the threaded joints, the said sleeve will move axially along the length of the shaft.
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。 5. The driving tool according to claim 3, characterized in that: said clamp has a hinge adjacent said tapered surface; and on the inner surface of the sleeve has a tapered slot, said tapered groove complementary with the tapered surface, so that when said sleeve toward said axially movable jaw to said hinge during extrusion, said tapered slot also moves along the tapered surface.
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 as claimed in claim, wherein said fusion device having an oppositely disposed outside recess in one end thereof, wherein said clamp has a number of inwardly from said surface outstretched drive lug, said drive lugs and the fusion device can be disposed opposite engagement recesses.
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. - species driving tool for implanting the interbody fusion device between adjacent vertebrae in the gap, the fusion means is hollow, the fusion device having a body, said body having a cylindrical inner flat surface and an opposite side wall of the cylindrical outer surface of disconnection, said outer surface having external threads, said driving tool comprising: an elongated shaft; and a pair of said shaft connecting one end, opposite to each other clamp, said clamp offset from each other so that the fusion device disposed opposite flat side walls receiving therebetween; and an elongate shaft may be connected to the The first expansion of the flexible tube diameter clamp assembly, said flexible tube assembly having expandable folder a portion which can be from a small exposure to it can in the interior of the hollow fusion device expanded to a larger, so that it can grip the fusion card means a second lumen diameter.
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 as claimed in claim 7, characterized in that said elastically expandable tube clamp assembly comprising: a pair of said opposed tongs integral head, said head having through a central bore therein and a central aperture in said one end of said clamp and is located adjacent to the inner side of the annular flange of the clamp; and a slidably disposed in the center of among the expander shaft hole, said expander shaft having an end portion, when said expander shaft is placed in said central bore, the end portion from a small to enable it in the a first central bore diameter to an expanded slidable annular flange adjacent said larger second diameter, whereby when said expander shaft is retracted into the central bore of said, said enlarged end portion so that said annular flange is gradually expanded to the degree of engagement with the lumen of the fusion device.
Description  translated from Chinese

用于植入体内融合装置的驱动工具 Implanting the interbody fusion device for driving tools

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 submission, 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。 Name of the application, "Apparatus and method for restoring the body to normal anatomy of the spinal fusion" divisional applications. 技术领域 Technical 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 damaged disc between the vertebrae in the void left after removing artificial implants. 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 easy arthrodesis between adjacent vertebrae or spinal fusion, while maintaining or restoring the normal spinal anatomy at the particular vertebral level of the implant.

背景技术 Background

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 spinal surgery to correct the causes of low back pain factors were steadily growing. 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 caused by disc between adjacent vertebrae injury or disease. 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 undermine the function of disc anatomy. 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 popular surgical method of dealing with such situations surrounding the affected disc is a fusion of two vertebrae. 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 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 the removal of the damaged disc, it must be something to put into the intradiscal space, otherwise the gap will shrink, causing the nerves extending along the spinal column damage.

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 shrinking gap within this disk, we need to fill this gap with bone or 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 to put between the adjacent vertebrae, typically placed in the rear of the vertebrae, the use of a plate or vertebrae across the lesion to stabilize the spine rods. 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 technology, when the formation of a fusion, used to maintain the stability of the spine portion 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, by the level of the spinal implant a rod or plate to stabilize during fusion surgery often require time-consuming and complicated.

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。 So he suggested that the solution remove the disc after a gap of a better way to stability is to: make the vertebrae between their respective end plates fused, preferably without the use of front board or back boards. 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。 People have done a lot of effort to develop a disc injury both can be used instead of a gap, at least in the joint plant in intact to maintain stability within the disk before fixing gap between adjacent vertebrae acceptable dish into the matter. 这些"体内融合装置"具有多种形式。 These "interbody fusion devices" have a variety of 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。 Cylindrical implant form thereof. 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 Bagby, Brantigan U.S. Patent No. 4,878,915, Ray's 4,961,740 and U.S. Patent No. 5,055,104 and Michelson in 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。 As patent Ray, Brantigan and Michelson in these cylindrical implants, the exterior of the cylinder are threaded interbody fusion device for insertion. 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 integration of the implant 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's first US 4,743,256, 4,834,757 and No. 5,192,327 patent describes a device of this type.

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 are generally upright cylindrical. 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。 Others have developed a non-constant cross-section of other implants for interbody 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, US Patent No. 4,714,469 to McKenna shows a hemispherical implant vertebral end plates extending elongated protrusions with the. 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。 United States Patent No. 4,714,469 shows a Kuntz of friction to optimize the prosthesis and the adjacent vertebral bodies fit between the bullet-shaped prosthesis. 最后, Finally,

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 have allowed the structure of the implant. 美国第4878915、4743256、4349921 和4714469号专利描述了几种实心的植入物。 United States Patent No. 4,714,469 describes 4878915,4743256,4349921 and several 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 allows the bone has grown through the implant certain technical features. 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 patent describes apparatus is the representative of this type of hollow implant, typically prior to insertion of such an implant to the intradiscal space is filled with autologous bone it. 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。 Such an implant with some of the hollow interior of the implant communication hole, whereby a path for tissue growth between the vertebral endplates and the implant located in the bone or bone substitute is formed. 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。 The gap in the spare disk, it is preferable that the end plate is reduced, so that the blood supply to the bone, which is conducive to the growth of this organization. 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 Michdson implant to maintain openness and stability of the motion segment to be fused played a helpful role. 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 occurs, the implant itself acts as a solid body bone fixator.

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 device. 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。 Although already recognized that the bone can substitute within the implant bone or bone grown hollow implant is to achieve a convergence of the best technical means, but most have been difficult to achieve this integration means, at least in the absence of some additional stabilizing device (such as a rod or plate) it is difficult to achieve with the help of this integration. 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, these devices are not strong enough in some of the structure, it can not withstand the most frequently applied to the fused vertebrae level (ie lower vertebra of the lumbar region) 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 need to provide a capability to optimize bone ingrowth and has sufficient strength, the formation of the joint can be fixed before the support has a hollow body section of spinal 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 of bone growth in avoiding stress shielding embedded in the implant autologous bone has played 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, autologous bone will not endure a certain load, it has been found that this load is to ensure rapid and complete fusion required. 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, within the implant in the bone may reabsorb or evolve into simply fibrous tissue, rather than a bony fusion, which would 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 large that the case does not have enough support to avoid subsidence into the adjacent vertebrae level.

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 does not solve the above-mentioned prior devices relates to maintaining or restoring the normal anatomy of the spinal fusion segment 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 In already have means for recovery of the arc

需求被忽略了。 Demands were 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, US Patent No. 4,501,269 is represented Babgy, such as commercially available, SpineTech the BAK device, adjacent vertebral bodies fitted with special cylindrical implant reamer reaming. 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 establish normal curvature, and then insert the implant. 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 such a structure, Figure l shows a cylindrical implant is inserted into the gap between the implant and the mounting plate substantially adjacent healthy vertebrae depth. 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 the load-bearing bone in the spine, but also due to the general difficult to pass under the rear reaming maximum lumbar lordosis, which on the back of excessive reaming method is generally not well accepted. 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 of this, not restore lordosis efforts, therefore, as the material in the vertebrae surrounding the implant stable, this cylindrical implant is likely to cause a kyphotic deformation. 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, thus often leading to re-operation. 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 therefore still a need for a bone that optimizes the ability to grow while still maintaining its strength and 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。 It also needs to be capable of maintaining such an implant or restore normal anatomy of the spinal implant placement 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 implants must have sufficient support and withstand heavy loads arising at the level of the spinal implant placed on the strength, while the entire process should remain stable.

发明内容 DISCLOSURE

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 the existing legacy device unresolved problems, the present invention contemplates a hollow threaded interbody fusion device can be used to restore the normal angular relationship 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 has an elongated body that substantially tapered along its entire length, and having a hollow lumen, the outer diameter of the large body

于相邻椎骨之间的间隙。 The gap between the 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。 The body having an outer surface, said outer surface having a number of oppositely disposed, tapered cylindrical portions and between said pair of oppositely disposed cylindrical portion, the flat tapered side surfaces. 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。 Therefore, from one end view, the fusion device is like a cylindrical body, the sides of the body along the body is cut into the outer diameter of the chord plane. 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。 The cylindrical portions are threaded so that the body is inserted in a controlled manner and joined to 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 at an angle into a cone, in one embodiment, this angle is consistent with the normal lumbar lordosis angles. 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 some openings on the side of the flat surface is formed, and a pair of elongated opposite bone ingrowth slots provided on the cylindrical portion is formed. 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。 The best lateral groove width of bone growth is effective in about half the width of the cylindrical portion of the inner groove defined range.

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 the fusion device is inserted into the disc space in the driving tool. 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 driving tool includes a shaft, one end of the shaft having a pair of mutually opposed tapered clamp. 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。 This seam clamp means connected to a hinge shaft, the hinge so as to open the clamp so commissure fusion device sandwiched therebetween. 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。 Driving tool further comprising a sleeve surrounding said shaft disposed coaxially, the sleeve may 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, you can use an internal expanding collet, during insertion closely support to live the fusion device from the inside.

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 same shape of the outer surface of the cylindrical portion of the tapered shape 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 facing surface of the flat side corresponding to the fusion of the surface of the 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 side surface of the flat toward the inside of the clamp and the surface of the fusion device contacts the outer surface of the fusion device clamps combined into a complete conical to facilitate screwing The fusion device is inserted manner. 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。 Toward the inner side of the upper surface of the clamp may also have several protruding portion for fusion joining apparatus of the hole, so that the apparatus is driven into rotation and into the disc space.

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 for 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 expansion in the disc space and the adjacent vertebral end plates drilling diameter equal to the inner diameter step of the threaded fusion device hole. 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。 Inserting a sleeve constituting the drilling step and the following step of implanting the fusion device working channel. 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 screwed into the prepared hole. 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 angular separation of adjacent vertebrae achieved.

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, the insertion point at the rear of preparation, that is, from the rear of the expansion of the disc space and the vertebral end plates to drill 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 is also constituted drilling and insertion step of the 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, so that the flat side wall facing the adjacent vertebrae. 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。 Then rotate the device, so that on the cylindrical portion of the outer threads 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 adjacent vertebrae will separate certain angle, thus restoring the normal anatomy of lordosis. 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; Figure 1 is a prior art side view of the fusion device sagittal plane;

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 Figure 2 is an example of the body an enlarged perspective view of the 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; Figure 3 is a sectional view taken along line 3-3, as shown in the body viewed in the direction of arrow 2 in FIG fused side cross-sectional view of the apparatus;

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

图5是图2所示的体内融合装置的顶视图; Figure 5 is a top view of the interbody fusion device shown in Figure 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; Figure 6 is a view from the front of the spine when the AP side view showing the body shown in the two figures fusion device is implanted in the body located between the L4 and L5 gap in the case when;

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 of the sagittal plane shown in FIG. 6 implanted between L4 and L5 body 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; Figure 8 is a perspective view of another embodiment of the interbody fusion device according to the present invention; FIG. 9 is another aspect of the present invention according to a top view of an implant driver; FIG. 10 is one end of the implant driver engaging in FIG. 2 interbody fusion enlarged perspective view of the apparatus shown;

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; IO as shown in FIG. 11 is a cross-sectional view of the implant engaging drive on the unit partially enlarged side interbody fusion;

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 adapted as shown in FIG IO engaging the interbody fusion device according to another embodiment

的植入驱动器的局部放大的侧剖视图; The cross-sectional view of a partially enlarged implant driver side;

图13 (a) -13 (d)表示根据本发明的另一方面的植入体内融合 Figure 13 (a) -13 (d) shows 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 steps of the method of apparatus (e.g. apparatus shown in FIG. 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。 Figure 14 (a) -14 (d) shows the fusion device implanted in the body (e.g., the apparatus 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 principles of the present invention will be better understood, the present invention will be described below with reference to several embodiments 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 this is not intended to limit the scope of the invention, those skilled in the art of the present invention will be natural to expect a 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。 Figure 2-5 illustrates the integration in accordance with one aspect of the present invention, apparatus 10 in vivo. 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 consists of a conical body 11 constituting the rigid 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 made of medical grade stainless steel or titanium, or other strength characteristics are suited to the above-mentioned suitable material. 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 a biocompatible porous material, such as porous tantalum provided by Implex Corp made. 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 12 has a front 13 and a rear end, and their anatomical location within the implant device 10 in the disc space when 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)。 Conical body 11 defines a hollow interior 15, 15 surrounded by the internal wall of the body 16, and its front end 13 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 possible shape to receive autograft bone or bone substitute, to promote between adjacent vertebrae and across the intradiscal space of solid fusion.

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 present 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 define a set of external threads 18 and a discontinuity at the front end of the implant complete

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 intradiscal space located in the vertebral end plates "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 known in the art, several shapes in order to be screwed into the vertebrae. 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, these 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 will not be subjected to 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 threaded engagement of the device to be implanted vertebral levels where the implant 10 and held in position for the desired quantity.

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 of the body 16 includes a pair of parallel truncated side walls 22, shown most clearly illustrates the 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 pair of side walls preferably flat to facilitate the fusion device is inserted between adjacent vertebral end plates, and the formation of a region for bone 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 truncated side walls 12-straight from the front end device at the rear end 13 extends to a complete thread 19. 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, the ends of the device 10 was not a full circle, the circle of the 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 along a pair of spaced approximately 12.0mm (0.472m) is formed by a line parallel chords, therefore, on both sides of the arc portion of the device it is cut off about and 90. 的角相对。 The diagonally opposed. 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。 This article will be described in detail the benefits and advantages of the fusion device 10 of the truncated side walls 22 brought.

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。 Conical body 11 of the device 10 includes a pair of openings formed blood vessels through the various truncated side walls 22 to 24 and 25 to determine. 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 into the disc space, the openings 24 and 25 are arranged along the side or toward 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。 The openings are for forming a passageway for the hollow interior 15 of the bone between the implant and the surrounding tissue vascularization. 此外,有些骨还可能通过这些开口生长。 In addition, some bone may 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 24 and 25 of the opening can guarantee to provide the best path for the formation of blood vessels, and to retain a lot of structure in the conical body 11 to withstand large axial load through the adjacent inner disc space between vertebrae.

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 identified a number of bone growth oppositely disposed slots 27, all of these slots are truncated side walls 22 with a 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, the grooves 27 is preferably directly adjacent to 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 are screwed into the vertebral end plates, the vertebrae will partially extend into the slot 27 in contact with the bone implant housed in the hollow interior 15 of the apparatus 10. 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 spinal fusion, bone ingrowth slots 27 are formed to provide the shape of the opening for maximum 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 preferably with the effective width of the threaded portion of the body closer. 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 the use of many small gaps existing devices can not promote the rapid and solid fixed joint 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 gap but also often leads to the growth of the formation of false joints and 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。 As the bone ingrowth slots 27 of the present invention is directly facing the vertebrae, they are not in the device must bear a greater load on the site. 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 have to bear by means of the interrupted threads 18 and throughout most of the load in the disc space between the vertebrae of the two end plates.

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 aspect, the distal end 12 of the body 16 may have a pair of diametrically opposed recesses 29, the shape of this recess 29 so that they can cooperate with the 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)。 In addition, the rear end of the implant material 13 on the end wall 17 may be provided with a mating member with a tool (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 further described herein, you can start a hexagonal recess to accommodate a hex driver 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 is a fusion device, the body 11 is tapered or conical, in other words, the front end of the apparatus 12 is greater than the outer diameter of the rear end 13 of the 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 around the center line 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 helps 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, the angle A helps restore normal lordosis and is located in this part of the curvature of the spine. 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。 Understandably, the implant may have non-tapered portions, as long as these portions do not affect the function of the body can be tapered.

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。 Front and rear ends of the implant 10 and the outer diameter of the cone angle A fusion device together, determine its location when when the implant is placed or screwed to be formed between the adjacent vertebrae The angular divergence amount. 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 uses a two illustrates the preferred structure of the fusion device 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 device 10 is placed between the lower lumbar vertebrae L4 and L5, threads 18 and 19 are screwed into the two vertebral end plates E of. 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 Figure 7, when the IO device is screwed into the end plates E, which pivot toward the vertebral level P forward along the arrow E direction. 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 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 further toward the pivot axis P advance along the direction of arrow I, the adjacent vertebrae L4 and L5 toward the direction of arrow S angularly spread. 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。 Fusion device 10 will determine the depth of insertion between the two vertebrae adjacent to reach the final lordosis 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 or the outer diameter of the thread crest 12

直径可以是16、 18或20mm,装置的全长为26mm。 Diameter can be 16, 18 or 20mm, full-length 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。 It is determined by the size of the device to be implanted in the horizontal angle and must meet 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 Figure 6, device 10 is sized so that two such cylindrical bodies 11 can be implanted into a 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 the two surrounding bone fusion material into another. 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 feature also facilitates the entire disk space fusion, and can be more firmly fixed to the device between adjacent vertebrae, preventing the device is a high load on the particular vertebral level of crowding out.

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)。 Opening 24 overall interbody fusion device in a particular embodiment, the formation of blood vessels on the rectangular, with dimensions of 6.0mm (0.236in) multiplied 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 formation of blood vessels opening 25 also rectangular, with dimensions of 4.0mm (0,157in) multiplied 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 smaller device 13. 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, its length is 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 formation of blood vessels opening 24, 25 and grooves 27 of these dimensions for bone growth and angiogenesis is the best. 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。 In addition, the size of these openings is not great, they compromise the structural integrity of the device, or they make it receive a bone in the hollow interior 15 of the fusion material during implantation can more easily be 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 Figure 7, when the device is positioned between the L4 and L5 vertebrae, the vascularization openings 24 and 25 formed in the side in contact with the vertebrae surrounding the highly vascularized tissue. 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。 Further, 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 shown in Figure 8 of the present embodiment of the invention, the interbody fusion device 30 is composed of a conical body 31 constitutes. 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。 Example foregoing fusion device 10- like, hollow body 34 defines a cavity 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 opening formed blood vessels. 并且,位于装置10的相对两侧的骨 Further, the bone located on opposite sides of the apparatus 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 the apparatus 36 extending around the implant a longer distance. 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 using a porous material (such as tantalum) is formed for tissue growth and fixed to the auxiliary surface of the adjacent bone, you can use this design. 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 of the embodiment shown in FIG. 8 can also be applied to certain vertebral levels, at these levels, the risk of being squeezed out of the maximum devices. 因此,通过增加螺纹的接触量来防止发生这类的挤出。 Therefore, by increasing the amount of contact screw to prevent the occurrence of such extrusion. 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, bone or substitutes to fill in the hollow interior 15 of the device 10, 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 present invention may be utilized implant driver 50 shown in FIG. 9 will interbody fusion device 10 implanted in the body. 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。 Implant driver 50 is comprised of a shaft 51 and a concentrically disposed around the shaft sleeve 52.. 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。 One end of the shaft with some clamps 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。 Clamp having a tapered outer surface 55 and a flat inner surface 56 adapted to the body of the 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。 The tapered outer surface 55 of the discontinuous consistent thread root diameter 18, so that the clamp 54 substantially fills the entire body wall 16 of 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 is connected across the vertebral end plates located at the opening of the threaded bore, so tapered outer surface 55 of the clamp promoting interbody fusion device IO screwing.

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 comes with tongs 56 extending from the inner surface of the interlock pin 58 and drive lug 59. 图11更清楚地示出了这些部件的功能。 Figure 11 shows more clearly the function 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。 Look at Figure 9, the shaft 51 with a pair of tongs support 54 hinged slot 62. 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 seam 62 has a shape: it makes the clamp in a sufficiently dispersed state skew open nature, can be tapered interbody fusion device 10 is received in 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。 Located on shaft 51 defines a hinge 62 and the respective commissure tapered portion 63 between the clamp 54. 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 of the sleeve 52 located on the inner wall of the tapered grooves 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 toward the tongs then 54 forward, leaning tapered slot 67 tapered portion 63, thereby closing 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 pushed toward each other, and under pressure of the two gripping the interbody fusion device situated between the 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 has a threaded interface 65 which permits the sleeve 52 to be screwed onto the shaft or the longitudinal direction of the shaft from the shaft unscrew. 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, the interface 65 includes a threaded shaft 51 on the external thread and internal thread located 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。 Shaft 51 also has a pair of detents 69, after which the sleeve 52 is moved within a limited range, the range only to receive the interbody fusion device 10 leaving the clamp 54 to move independently of the range required for a sufficient distance .

图IO和11示出了植入驱动器的使用过程。 Figure 11 shows the IO and implant driver during use. 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 flush 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, can be placed two stop pins 58 to form blood vessels located in each of the truncated side walls 22 on the opening 24. 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, the driving projection 59 is engaged with the front end of a tapered body accommodating ll driving tool recess 12 on 29. 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 drive cam 59 combined, the interbody fusion device IO tightly clamped, so the device can be threaded into the vertebra located in the opening attack of silk or tapping.

图12示出了植入驱动器的另一实施例。 Figure 12 shows the implant driver of another embodiment. 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。 Drive 90 comprises a shaft 91 having a length sufficient to ensure that the gap extending from the inner disc of 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。 A defining a pair of opposed jaws each end of the shaft 91 and the head 93 is connected to the shape of each clamp enables them to level the fusion device 10 of the truncated side walls 22 flush. 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 sample, the outer faces of the cylindrical clamp 53 of the cylindrical threaded portion of the device - with the previously described implant driver 50, two clamps 54.

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 With the implant driver 50 is different from the embodiment shown in FIG. 12 in the drive 90 utilizing

-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 expanding collet assembly to firmly grip the fusion device 10 card 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 has a through hole in which the central sleeve 95. 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。 One end of collet 94 is an annular flange 96, annular flange 96 at least initially having a slightly smaller than the inner diameter of the fusion device 10 of the end portion 12 diameter. 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。 Expander shaft 97 in a slidable manner through the sleeve aperture 98 and having an end portion with an enlarged end portion 98 near the annular flange 96 and extending 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。 Flaring axis enlarged end portion 97 at its leading end 98 of diameter less, so that it can slide in the sleeve bore 95, starting from the end of the beginning, the end portion 98 is larger than the diameter gradually increased to cover the hole diameter.

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。 Drive implant removal tool 90 comprises a shaft 99, said shaft 99 to be slidably disposed in the shaft 91 defined by the bore 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 shaft 99 has an expander shaft locking hub 102 engages the locking chamber 101 on the end portion 97. 拆卸工具轴99伸至轴91的端外,供外科医生持握。 Removing the end of the tool shaft 99 extends to the outer shaft 91 for the surgeon grip. 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 removal tool shaft 99 is pulled out, it pulls the expander shaft 97 from the annular flange 96 of the sleeve 94 is pulled out so that the end portion 98 is gradually widened engaging hole 95 in sleeve. 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。 With the front end portion 98 is further moved in the sleeve bore 95, the annular flange 97 to expand from an initial diameter to a larger second diameter sufficient to firmly retaining the lumen 10 of the fusion device to live. 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 fusion device, the device can be inserted into the IO operation zone, then, can be pushed to the sleeve shaft reamer hole outside to release the enlarged end, thus releasing fusion device open .

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) shows an anterior approach. 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, we need to set the appropriate implant fusion device, preferably bilaterally start. 在这前方插入法的第一步中, In the first step of the 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 A dilator 75 between the first place to the vertebral end plates E of the two to expand the L4 and L5

之间的盘间隙。 The disc space between. (当然,应该理解,这一步骤也可用于其它的椎骨 (Of course, it should be appreciated that this step can also be used for 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 Figure 13 (b) of the second step shown, a 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 can be a known method 76 of sleeve-shaped design, with the vertebral body so that it can securely engage the front, 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 laparoscopy (laproscopic) type of implantation, the sleeve 76 is the role played by 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 Figure 13 (b) shown in this step, a known drill 77 into the sleeve with the drill hole drilled in the two adjacent vertebrae. 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 be tapped in the holes, to facilitate screwing the fusion device, although this step is not essential.

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。 Shown in Figure 13 (c) of the next step, the implant driver 50 gripping fusion device IO, and insert it to the sleeve 76 until the starter thread 19 contacts the bone on the 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, you can use the implant driver fusion device 50 will open in the IO screwed into the vertebral end plates of the wire-tapping or tapped holes. 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, in this step, may be driven by other suitable tools, such as screw-type drive means driving tool recess 10 of the front end 12 of the device 29 engaging located. 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 previously described, the degree of insertion of the fusion device 10 determines the increase in the level of the spine, or to make the level of the spine to restore lordosis amount. 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, the fusion device 10 is left in place. 可见, 一旦被植入,封闭的端壁17便朝向该椎骨的后端。 Visible, once implanted, the closed end wall 17 toward the rear end of the vertebrae will. 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。 Located in front of the hollow interior 15 is open, but if necessary can be made of metal or plastic material which encloses.

在第二种发明方法中,图14 (a) -14 (d)示出了后方插入法。 In the second inventive method, FIG. 14 (a) -14 (d) shows a rear insertion method. 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 behind the insertion method with the anterior approach is similar except that 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 mounted from the back into the area 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 insertion method may need to be peeled off or removed vertebrae for receiving 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 sleeve 76 through the expansion of the disc space. 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 understood that the disc space expansion to a certain extent, this level is the acceptance of a directly facing the vertebral endplates E of the truncated side walls 22 of the implant 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, as shown in 14 (c), the bone ingrowth slots 27 laterally toward, rather than toward the lateral, 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 can use a suitable driving tool 80 so that the fusion device 10 through the outer sleeve 76, and into the disc 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 having a projection 81, shaped with the opening at the rear end 10 of the fusion device end wall 17 of the recess 13 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) is fixed to the drive unit 10 on 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 with respect to the pivot axis P of the vertebrae reached the proper depth, the tool 80 can be taken along by the drive 14 (c) referred to the direction of rotation indicated by arrow R 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。 With the rotary drive means 80, the device itself is rotated so that the interrupted threads 18 start to cut into the end plates E located at 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, the implant adjacent images as a cam dispersion direction (c) referred to in the arrow S direction in FIG. 14 along the vertebrae apart. 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。 Because only one rotation of the implant can be locked to the vertebra, so that cam insert some extent is a more convenient method of insertion. 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, previously discussed screw insertion technique requires formula means continuously screwed to its upper 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。 Both techniques of any kind, you can make use of X- rays or other suitable techniques to test the device 10 relative to the position of the adjacent vertebrae fused in order to establish 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, you can pre-determine the preferred implant insertion depth, and in the determination of the depth of the implant from the patient's body was placed between the vertebrae.

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。 Visible, the body of the present invention, the fusion device 10, 50, and advantages of the method of the present invention has a significantly over the prior devices and techniques drive implantation. 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 is a hollow threaded insert, to maximize the potential of mining the bone fusion 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 in its axial spine is subjected to considerable load, at least until solid fusion is achieved, 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 also comes with angiogenesis and tissue growth for the components that accelerate the convergence speed and improve the strength of the integration into the bone. 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 conical shape of the implant allows the surgeon to restore and maintain the right angle 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 and loss of balance had such serious problems associated apparatus. 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。 Device and implant driver to another advantage of the invention is the use of a laparoscopic insertion method either from the front can also be inserted from the rear. 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。 According to the vertebral level, two kinds of methods are desirable insertion, therefore, important that the implant is adapted to be inserted from two directions. 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 front of the insertion method, the use of screw-in technique (vs. pounding) to control the insertion device at the rear of the insertion process, with a slide-in and cam method 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 Despite the use of the drawings and foregoing description of the present invention are shown and described, but the drawings and descriptions are illustrative only and not limiting, it being understood that just shown and described preferred embodiments, the present fall All changes in the scope and spirit of the invention.

改进都应当受到保护。 Improvement 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 a device for spinal love 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。 Case, but the structure and methods of the present invention can also 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, although the display device according to 10 over its entire length is tapered in the preferred embodiment, but with non-tapered or reverse tapered portion still fall within the scope of the present invention, the resulting device .

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