CN1870952B - elastic implant - Google Patents
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- CN1870952B CN1870952B CN2004800305254A CN200480030525A CN1870952B CN 1870952 B CN1870952 B CN 1870952B CN 2004800305254 A CN2004800305254 A CN 2004800305254A CN 200480030525 A CN200480030525 A CN 200480030525A CN 1870952 B CN1870952 B CN 1870952B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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Abstract
Description
技术领域 technical field
本发明涉及权利要求1或权利要求3前序部分对应的植入物和权利要求19前序部分对应的制造植入物的方法。 The invention relates to an implant according to the preamble of claim 1 or claim 3 and a method of manufacturing an implant according to the preamble of claim 19 . the
背景技术 Background technique
在现代医学中,使用植入物可以弥补或最大程度降低人体或动物体缺陷的影响。例如,椎骨或椎间盘的间隔支撑器可以用来替代椎骨体或椎间盘。又如,脊柱加强或稳定系统可以是通过将椎弓根螺钉固定于椎骨并通过连接杆相互连接,以便椎骨相互间的距离、排列能得到调整和固定。 In modern medicine, implants are used to compensate or minimize the effects of defects in the human or animal body. For example, spacer supports for vertebrae or intervertebral discs can be used in place of vertebral bodies or intervertebral discs. As another example, the spinal reinforcement or stabilization system can be fixed to the vertebrae with pedicle screws and connected to each other through connecting rods, so that the distance and arrangement of the vertebrae can be adjusted and fixed. the
对所有植入物来说,植入物材料能与人或动物机体相容是很重要的,也就是说,不引起排斥反应或者不会由于其分解现象而导致机体负担。因此,植入物的材料选择实质上是受限制的。 For all implants it is important that the implant material is compatible with the human or animal organism, that is to say does not cause rejection or burden the organism due to degradation phenomena. Therefore, the choice of materials for implants is substantially limited. the
此外,最好以尽可能简单特别是以很少部件的方式制成植入物,因为部件的组合需要增加装入植入物的手术费用,另一方面,在各种部件相互连接的地方更容易出错从而更可能发生故障。因此,特别推荐制成一体化的植入物。 In addition, it is preferable to make the implant as simple as possible, especially with few parts, because the combination of parts requires an increase in the surgical cost of inserting the implant, and on the other hand, it is more difficult where the various parts are connected to each other. Error prone and thus more likely to fail. Therefore, it is particularly recommended to make an integral implant. the
然而,与之相反的是,植入物必须实现多种功能,这又希望使用不同的材料和/或由不同部件组成植入物。比如,对于间隔物希望它们都不但实现填充空间并保持椎骨相邻间的一定距离的功能,而且它们还有利于各椎骨之间一定的相互运动,即在一定的狭窄范围内起着类似关节的作用。为此,可以采用比如根据DE 10056977 C2所述的间隔支撑器,其中在与椎体相邻的支撑件之间,布置有由紧密的机织物或编织物材料制成的、在植入物的纵向上可拉伸的波纹管形的管件。但这带来了前面所述的缺点:需要使用必须相互连接在一起的几种不同材料,而这就增加了出错的可能性。而且,虽然已经有了一定弹性即具体的说是可拉伸性、可压缩性和可弯曲性是其优点的植入物,但由于上面所述的有关连接技术或材料选择的问题,到目前为止还是没被列入考虑范围。 Contrary to this, however, the implant has to fulfill multiple functions, which in turn makes it desirable to use different materials and/or to compose the implant from different parts. For example, for the spacers, it is hoped that they not only fulfill the function of filling the space and maintaining a certain distance between adjacent vertebrae, but also facilitate a certain mutual movement between the vertebrae, that is, they act like joints within a certain narrow range. effect. For this purpose, a spacer support can be used, for example according to DE 10056977 C2, wherein between the supports adjacent to the vertebral body, there is arranged a spacer made of a dense woven or braided material between the implants. A bellows-shaped pipe that is stretchable in the longitudinal direction. But this brings with it the aforementioned disadvantage of requiring the use of several different materials that must be joined together, which increases the possibility of error. Moreover, although there are already implants whose advantages are certain elasticity, specifically stretchability, compressibility and bendability, due to the above-mentioned problems related to connection technology or material selection, so far So far it has not been considered. the
从EP0669109B1中可以知道这样一种稳定相邻椎骨的稳固装置:它包括2个单轴椎弓根螺钉和一条带状物,该带状物分别由一个紧固螺钉固定在椎弓根螺钉的接收部位,该所述装置还包含几个支撑元件,为套在带状物上的耐压体。然而,除了各种部件很多的缺点外,该稳固装置还有一个问题,即当套上支撑元件时它就不再有弹性。使用单轴椎弓根螺钉进一步限制了该稳固装置的应用。从EP1188416A1中可以知道另一种类似的稳固装置,其中使用多轴椎弓根螺钉而不是单轴椎弓根螺钉。 Such a stabilizing device for stabilizing adjacent vertebrae is known from EP0669109B1: it consists of 2 uniaxial pedicle screws and a ribbon, which is respectively fixed by a fastening screw at the receiving end of the pedicle screw. position, the device also includes several supporting elements, which are pressure-resistant bodies that are sheathed on the belt. However, in addition to the disadvantage of having a large number of various parts, this stabilizing device has the problem that it is no longer elastic when the support element is put on. The use of uniaxial pedicle screws further limits the application of this stabilization device. Another similar stabilization device is known from EP1188416A1, in which polyaxial pedicle screws are used instead of monoaxial pedicle screws. the
从US2003/0109880A1中可以知道这样一种动态椎骨稳固装置:该装置包括锚定在椎骨上的第一螺钉和第二螺钉,每个螺钉都有用于插入一个把螺钉连接起来的弹簧的接收部位和一个这样的弹簧。弹簧自身作为一个整体以拉伸弹簧形式形成为线圈紧密相邻的螺旋弹簧的形状并通过紧固螺钉固定在接收部位。但该装置也存在风险,即由于弹簧对紧固螺钉压力的弹性屈服,因而骨螺钉和弹簧之间的固定松弛。 Such a dynamic vertebral stabilization device is known from US2003/0109880A1: the device comprises a first screw and a second screw anchored on the vertebrae, each screw has a receiving part for inserting a spring connecting the screws and One such spring. The spring itself is formed as a whole in the form of a tension spring in the shape of a helical spring with closely adjacent coils and fixed at the receiving site by fastening screws. However, this device also carries the risk of loosening the fixation between the bone screw and the spring due to the elastic yielding of the spring to the pressure of the fastening screw. the
发明内容Contents of the invention
因此本发明的目的是提供这样的植入物,其由尽可能简单的部件组成,特别是由一件或容易连接的几件组成;而且其中除了其他功能以外,要保证植入物或者其一些区域具有一定的弹性和活动性。除此以外,该装置应易于制造、植入,使用安全,经久耐用且应用广泛。 It is therefore an object of the present invention to provide an implant consisting of as simple as possible parts, in particular of one piece or of several pieces easily connected; and wherein, among other functions, it is ensured that the implant or some of its Regions have a certain degree of elasticity and activity. Among other things, the device should be easy to manufacture, implant, safe to use, durable and versatile. the
上述目的通过如下的植入物来实现。 The above object is achieved by the following implant. the
本发明提供一种脊柱稳固装置,其包括第一骨锚固元件,其用于锚入椎骨,所述第一骨锚固元件具有第一端座;第二骨锚固元件,其用于锚入椎骨,所述第二骨锚固元件具有第二端座;以及连接部件,通过使所述连接部件容纳于所述第一端座和所述第二端座中,所述连接部件设置为将所述第一骨锚固元件连接到所述第二骨锚固元件,所述连接部件包括:第一刚性部,其具有第一刚性管状体,所述第一刚性管状体设置为连接到所述第一骨锚固元件;第二刚性部,其具有第二刚性管状体,所述第二刚性管状体设置为连接到所述第二骨锚固元件;以及弹性部,其具有带螺旋凹陷的弹性管状体,所述弹性管状体布置为位于所述第一刚性部和所述第二刚性部之间,其中,所述脊柱稳固装置还包括用于替代与所述连接部件相邻的椎间盘或椎骨的间隔支撑器,所述间隔支撑器具有管状体,所述管状体具有带螺旋凹陷的弹性区段。 The present invention provides a spinal stabilization device comprising a first bone anchoring element for anchoring into a vertebra, the first bone anchoring element having a first end seat; a second bone anchoring element for anchoring into a vertebra, The second bone anchoring element has a second end seat; and a connecting member configured to connect the first end seat by being received in the first end seat and the second end seat. A bone anchoring element is connected to the second bone anchoring element, the connecting part comprising: a first rigid portion having a first rigid tubular body configured to be connected to the first bone anchoring an element; a second rigid portion having a second rigid tubular body configured to be connected to the second bone anchoring element; and an elastic portion having an elastic tubular body with helical depressions, the an elastic tubular body is disposed between the first rigid portion and the second rigid portion, wherein the spinal stabilization device further comprises a spacer supporter for displacing an intervertebral disc or vertebra adjacent to the connecting member, The spacer support has a tubular body with a resilient section with helical depressions. the
本发明建立于以下认识:关于用于人体和动物体的植入物,形状基本上是根据其对植入物在机体实现的一项或者多项功能来选择的。这些功能可能也包括植入物具有一定程度的活动性或者弹性。而在其它一些情况下,植入物内的活动性或者弹性基本上不是必要的,但可能是最好能有的或者是有了会更有利的。关于这点,在下面的说明中,活动性和弹性功能将被称为次要功能,而所有其余功能称为首要功能。 The invention is based on the recognition that, with respect to implants for the human and animal body, the shape is essentially chosen according to the function or functions it fulfills for the implant in the body. These functions may also include a certain degree of mobility or elasticity of the implant. In other cases, however, mobility or elasticity within the implant is not essentially necessary, but may be desirable or advantageous. In this regard, in the following description, the mobility and resilience functions will be referred to as secondary functions, while all remaining functions will be referred to as primary functions. the
在第一组情况中,现有技术是通过附加部件和/或不同类型的材料来获得活动性或弹性的。这项发明采用了另一途径,其中活动性或弹性不是通过另外的材料或附加的单独部件来实现,而是在形成为一体的植入物或者植入物部件中,通过对材料凹陷的设计进行规定来实现具有弹性或活动性的区域的。 In the first group of cases, prior art mobility or elasticity is achieved through additional components and/or different types of materials. This invention takes an alternative approach where mobility or elasticity is achieved not through additional material or additional separate components, but through the design of recesses in the material in an integrally formed implant or implant component Provisions are made to achieve areas of resilience or mobility. the
在第二组情况中,活动性或弹性不是绝对必要的功能,根据本发明,也通过在所需功能规定的形状上附加设置相应区域中的相应材料凹陷实现此附加功能。 In the second group of cases, mobility or elasticity is not an absolutely necessary function, which is also achieved according to the invention by the additional provision of corresponding material depressions in the corresponding regions on the shape prescribed by the desired function. the
通过这种方式,就能避免采用附加弹性材料和相应连接部件或附加独立部件,而以简单的方式获得植入物或其部件的弹性和活动性。关于这方面,弹性或活动性功能可以是植入物必要功能之外附加设置的,或者作为必要功能的组成部分。特别是,这样就能以简单而可靠的方式,特别是在形成一体的植入物或其部件中,产生压缩和/或拉伸区并在一定的限制内,形成弯曲关节或扭转元件等。 In this way, the elasticity and mobility of the implant or its parts can be obtained in a simple manner without the use of additional elastic material and corresponding connection parts or additional separate parts. In this respect, the elasticity or mobility function can be provided in addition to or as a component of the necessary function of the implant. In particular, this makes it possible to produce compression and/or tension zones and, within certain limits, to form bending joints or torsion elements etc. in a simple and reliable manner, especially in integrally formed implants or parts thereof. the
相应地,对于最好形成一体的植入物可以使用稳定、坚硬,特别是在特定应用条件下,使用刚性的、最好是有弹性的刚性材料如钛、钛合金、塑料等等。一般来说,所有不会引起排斥反应或出现给机体带来负担的分解现象的生物相容性材料都可以是候选材料。 Correspondingly, for implants which are preferably formed in one piece, stable, hard, and especially under specific application conditions, rigid, preferably elastic, rigid materials such as titanium, titanium alloys, plastics, etc., can be used. In general, all biocompatible materials that do not cause rejection or disintegrate that burden the body can be candidates. the
材料凹陷最好是在植入物或者植入物部件的壁上形成的凹槽状凹陷或开孔。材料凹陷的形状、数量和排列可依具体情况进行调整以符合负载要求。 The material depressions are preferably groove-like depressions or openings formed in the wall of the implant or implant component. The shape, number and arrangement of the material depressions can be adjusted on a case-by-case basis to meet the load requirements. the
作为满足多种要求的一种通用形状,材料凹陷特别适合于形成围绕植入物主体延伸的螺旋状,从而特别形成螺旋弹簧类型的形状,而且特别适合于通过材料凹陷而在螺旋弹簧元件中的相邻螺旋条之间形成自由空间。除了容易生产、相关材料选择面更广以外,它还利于实现更大的弹性。 As a universal shape that meets many requirements, the material depression is particularly suitable for forming a helix that extends around the implant body, thereby forming in particular a helical spring type shape, and is particularly suitable for forming in the helical spring element through the material depression Free spaces are formed between adjacent spiral strips. In addition to easier production and a wider choice of relevant materials, it also facilitates greater flexibility. the
特别有利的是,两个材料凹陷可形成为成对并行或者双飞的螺旋形。这样,可特别形成相互嵌含布置的两个螺旋弹簧。如果这种螺旋状凹陷区域的高度相同,那么双螺距的双螺旋状凹陷可取代低螺距的单螺旋状凹陷。 It is particularly advantageous if the two material depressions can be formed in parallel in pairs or in the shape of a double-flying helix. In this way, in particular two helical springs arranged nestedly in one another can be formed. If the height of such helical depressed regions is the same, double pitched double helical depressions can replace low pitch single helical depressions. the
弹性的植入物特别适合于,也特别明显适合于作为一个系统一起使用的,椎骨和/或椎间盘的间隔支撑器和椎弓根螺钉装置的连接杆,以使患者的脊柱保持相对稳定的同时又有适度的活动性。 Resilient implants are particularly suitable, and particularly well suited, for use together as a system of spacer supports for vertebrae and/or intervertebral discs and connecting rods for pedicle screw arrangements to keep the patient's spine relatively stable while There is also moderate activity. the
间隔支撑和重力传递功能是椎骨和/或椎间盘间隔支撑器的首要功能,而阻尼效应和活动性是作为第二功能的附加功能。 The space support and gravity transmission functions are the primary functions of the vertebral and/or intervertebral space support, while the damping effect and mobility are additional functions as secondary functions. the
支撑和连接功能对于连接杆来说是其首要功能。 The supporting and connecting functions are the primary functions for connecting rods. the
对于植入物或间隔支撑器或连接杆来说,已证实最好使其形成为具有中间管状体以及在端部有连接元件的管状体,并且用于获得弹性的材料凹陷最好形成为管状体中的一个或两个螺旋形孔的形式,从而使该部件基本上形成一个或两个相互嵌含布置的螺旋弹簧形状。间隔支撑器的连接元件最好有连接相邻机体部位如椎骨的装置,如在端部的钩状突起和/或在外层表面的凹陷、凹槽和开口,以便间隔支撑器能长入组织并与其交织在一起。但在这点上,不要把该连接元件的孔洞或者凹陷与管状体中用于获得间隔支撑器的弹性和活动性的材料凹陷相混淆。由于连接元件完全与相邻机体部位比如椎骨交织在一起,它们不对椎骨的弹性或活动性作出贡献。 For implants or spacer supports or connecting rods, it has proven to be best to form them as tubular bodies with a central tubular body and connecting elements at the ends, and the material depressions for obtaining elasticity are best formed tubular In the form of one or two helical holes in the body, so that the part basically forms the shape of one or two helical springs embedded in each other. The connecting elements of the spacer support preferably have means for connecting adjacent body parts such as vertebrae, such as hook-like protrusions at the ends and/or depressions, grooves and openings in the outer surface, so that the spacer support can grow into the tissue and intertwined with it. But in this regard, do not confuse the holes or recesses of the connecting element with the material recesses in the tubular body used to obtain the elasticity and mobility of the spacer support. Since the connecting elements are completely interwoven with adjacent body parts such as vertebrae, they do not contribute to the elasticity or mobility of the vertebrae. the
把管状体连接到相邻机体部位的装置可以布置成,或者是与管状体形成一体特别是通过在管状体端部延伸的方式,或者是端部可分离例如能被旋入到管状体端部上的端板。 The means for connecting the tubular body to the adjacent body part may be arranged either integrally with the tubular body, in particular by means of extension at the end of the tubular body, or detachable at the end, for example capable of being screwed into the end of the tubular body on the end plate. the
采用这种可分离的端板或与管状体连接成一体的端板时,最好在带有材料凹陷的管状体周围至少设置一个弹性材料制成的套筒以 实现弹性或活动性;或在管状体内至少设置一个弹性芯部。这种最好是由人工橡胶制成的弹性芯部或者弹性套筒具有能准确调节管状体或间隔支撑器的弹性或刚性的好处。通过带相应凹陷的管状体和芯部和/或套筒的模块状排列,使用不同刚度的不同组件就能以简单的方式获得以阻尼意义准确限定刚度的植入物。这里,带有可获得弹性的材料凹陷的植入物部件与由一件能调整限定刚度的弹性材料组成的植入物部件的结合是本发明很基本的目的。为获得变更的刚度,只要改变部件的组合,即比如只要用不同刚度的另一芯部或另一套筒与弹性管状体一起用。虽然能想到套筒和芯部可以同时与弹性管状体一起使用,但为了简单起见,通常只使用管状体与芯部或管状体与套筒的一种组合。这里,套筒还具有保护带有最好是螺旋形凹陷的管状体不受外部影响的优点,然而与此相反,当使用芯部时,芯部受管状体的保护。 When using such a separable end plate or an end plate integrally connected with the tubular body, preferably at least one sleeve of elastic material is provided around the tubular body with material depressions to To achieve elasticity or mobility; or to provide at least one elastic core within the tubular body. Such an elastic core or sleeve, preferably made of elastomer, has the advantage of being able to precisely adjust the elasticity or rigidity of the tubular body or spacer support. Through the modular arrangement of the tubular body and the core and/or the sleeve with corresponding depressions, an implant of exactly defined stiffness in terms of damping can be obtained in a simple manner using different components of different stiffness. Here, the combination of an implant part with material depressions which can be made elastic with an implant part consisting of a piece of elastic material which can be adjusted to a defined stiffness is a very basic object of the invention. To obtain a modified stiffness, it is only necessary to change the combination of parts, ie for example just use another core or another sleeve of different stiffness with the elastic tubular body. Although it is conceivable that both the sleeve and the core could be used with the elastic tubular body, for simplicity only one combination of the tubular body and the core or the tubular body and the sleeve is usually used. Here, the sleeve also has the advantage of protecting the tubular body with the preferably helical depression from external influences, whereas in contrast to this, when using a core, the core is protected by the tubular body. the
芯部和套筒最好都能通过在管状体端部布置端板来固定,在使用套筒的情况下,端板最好从管状体突出因此比管状体形成更大的直径。端板至少可部分地即在一侧与管状体连成一体,从而在此形成烧杯状。此外,端板还可以在一端或两端与管状体可分离地连接,比如通过螺钉或者螺纹连接。这里,外螺纹既能设在端板上,也能设在管状体上。 Preferably both the core and the sleeve can be fixed by arranging end plates at the ends of the tubular body, in the case of sleeves the end plates preferably protrude from the tubular body and thus form a larger diameter than the tubular body. The end plate can be integrated at least partially, ie on one side, with the tubular body so that it forms a beaker here. Furthermore, the end plate can also be detachably connected to the tubular body at one or both ends, for example by screws or threads. Here, the external thread can be provided both on the end plate and on the tubular body. the
优选地,该植入物或带有用来获得弹性和活动性的材料凹陷的管状体在纵向方向上沿着间隔支撑器纵向轴可拉伸或压缩0.5%到20%,特别是1%到15%,并可关于与间隔支撑器的纵向轴相垂直的径向轴弯曲使邻近机体部位能相对于纵向轴偏转大约0.5到10度,特别是1到6度。此外,在优选的实施例中,可以绕纵轴扭动0.5到2.5度。 Preferably, the implant or tubular body with material depressions for elasticity and mobility is stretchable or compressible in the longitudinal direction by 0.5% to 20%, in particular 1% to 15% along the longitudinal axis of the spacer support. %, and can be bent about a radial axis perpendicular to the longitudinal axis of the spacer support so that adjacent body parts can deflect about 0.5 to 10 degrees, particularly 1 to 6 degrees, relative to the longitudinal axis. Furthermore, in a preferred embodiment, twisting is possible by 0.5 to 2.5 degrees about the longitudinal axis. the
在弹性植入物的又一种有利应用中,在椎弓根螺钉装置之间的区域内单轴或多轴椎弓根螺钉装置之间的连接杆可通过布置相应的材料凹陷而具有一定的弹性和活动性,而这弹性和活动性特别又可通过至少连接杆的部分结构是中空体而得到增强。杆状元件特别适用于 在各种程度的椎间盘缺陷情况中相邻椎骨的稳固和活动性限制。在制造过程中,通过改变杆状元件尺寸的简单方式来获得这些特性。 In yet another advantageous application of elastic implants, the connecting rods between uniaxial or polyaxial pedicle screw devices in the region between the pedicle screw devices can be provided with a certain degree of rigidity by arranging corresponding material recesses. Elasticity and mobility, which in turn can be enhanced in particular by the fact that at least part of the connecting rod is formed as a hollow body. Rod elements are especially suitable for Stabilization and mobility limitation of adjacent vertebrae in various degrees of disc defect. These properties are obtained in a simple manner by changing the dimensions of the rod-shaped element during the manufacturing process. the
比如,这样一种植入物能用一种简单的方式由一件物体制成,使一个或多个材料凹陷通过机械或化学加工,放电加工(EDM),激光处理或任何其它方式形成在物体的壁上。特别是一个或最好是两个材料凹陷可以螺旋形在物体周围或沿着壁设置。 For example, such an implant can be made from an object in a simple manner by having one or more material depressions formed in the object by mechanical or chemical machining, electrical discharge machining (EDM), laser treatment or any other means. on the wall. In particular one or preferably two material depressions can be arranged helically around the object or along the wall. the
在物体是实心体比如实心圆柱体时,可以在前面或者后面的辅助步骤中形成特别是与材料凹陷同轴的膛孔,从而优选地在弹性区域形成螺旋弹簧状。当使用管件材料时,就不必要钻中心部分。 When the body is a solid body, such as a solid cylinder, a bore can be formed in a preceding or subsequent auxiliary step, in particular coaxially with the material depression, so that preferably a helical spring is formed in the elastic region. When using pipe material, it is not necessary to drill the center section. the
较理想的是,通过管状体的激光处理来制成材料凹陷,因为在那种情况下,两个凹陷可在同一处理步骤中形成。借助激光,通过钻透管状体(例如,也可以是方形管)即可同时在两侧形成膛孔。同时旋转和推进管状体形成双飞螺旋。 Ideally, the material depressions are made by laser processing of the tubular body, since in that case both depressions can be formed in the same processing step. By means of a laser, the bores are formed simultaneously on both sides by drilling through the tubular body (for example, also a square tube). Simultaneously rotate and propel the tubular body to form a double fly helix. the
在另一方面,本发明涉及一种杆状元件,此元件用于连接至少两个骨锚固元件(bone-anchoring element),各个骨锚固元件有用于锚入骨的锚固区段和用于与杆状元件连接的接受部分,而该杆状元件包有由一件材料形成的至少一个刚性区段和一个弹性区段,并且弹性区段特别是形成为螺旋弹簧,和/或其中在弹性区段与刚性区段邻接的另一端上有第二刚性区段与弹性区段邻接,和/或其中弹性区段的外直径至少在一个位置与刚性区段的外直径不同,和/或其中该弹性区段至少某部分在与该杆轴线相垂直的某个方向上具有的外直径比另一方向上的小,和/或其中弹性区段的外直径是有变化的,和/或其中弹性区段有一个芯,和/或其中设有一个同轴膛孔贯穿该杆状元件。 In another aspect, the present invention relates to a rod-shaped element for connecting at least two bone-anchoring elements, each bone-anchoring element having an anchoring section for anchoring into a bone and for connecting with the rod-shaped element. The receiving part of the part connection, and the rod-shaped element is wrapped with at least one rigid section and an elastic section formed from one piece of material, and the elastic section is especially formed as a helical spring, and/or wherein the elastic section and A second rigid section adjoins the resilient section at the other end adjacent to the rigid section, and/or wherein the outer diameter of the resilient section differs from the outer diameter of the rigid section in at least one location, and/or wherein the resilient section At least some portion of the section has a smaller outer diameter in one direction perpendicular to the axis of the rod than in another direction, and/or wherein the outer diameter of the elastic section varies, and/or wherein the elastic section has A core, and/or wherein a coaxial bore is provided through the rod-shaped element. the
而且,在另一方面,该发明涉及一种骨稳固装置,含有至少两骨锚固元件以及如上面所述用于连接骨锚固元件的杆状元件,每个骨锚固元件都有用于锚入骨的骨锚固区段和接受区段,特别是骨锚固元件可以是单轴或多轴的骨螺钉。 And, in another aspect, the invention relates to a bone stabilization device comprising at least two bone anchoring elements and a rod-shaped element as described above for connecting the bone anchoring elements, each bone anchoring element having a bone for anchoring into the bone. The anchoring section and the receiving section, in particular the bone anchoring element, can be uniaxial or polyaxial bone screws. the
此外,该发明涉及一种制造杆状元件的方法,包含以下步骤: Furthermore, the invention relates to a method of manufacturing a rod-shaped element comprising the steps of:
准备一个刚性杆; Prepare a rigid rod;
最好用去除材料的方法在离该杆自由端的预定距离内至少一个纵向区段上形成螺旋弹簧区段,并且其中心部分可在轴向钻出或者留出,和/或在弹性区段的纵向上除去一限定的材料区域以在弹性区段的至少一个区域产生非圆形横截面,和/或刚性区段直径相对于弹性区段设置得较小。 Preferably, the helical spring section is formed on at least one longitudinal section within a predetermined distance from the free end of the rod by removing material, and its central part can be drilled or left in the axial direction, and/or in the elastic section. A defined area of material is removed longitudinally to produce a non-circular cross-section in at least one area of the elastic section, and/or the rigid section is made smaller in diameter relative to the elastic section. the
该发明特别涉及用于骨或椎骨稳固装置中的弹性元件,它大致是一个含有第一端及与其相反的第二端的圆柱体,所述圆柱体的相反各端都含有一个同轴孔且这些端中至少一端含有内螺纹用于连接到骨螺钉的螺帽和/或螺杆或者用于连接到杆区段或板,其中特别是两端的每端都有内螺纹。 In particular, the invention relates to a resilient member for use in bone or vertebral stabilization devices, which is generally a cylinder having a first end and a second opposite end, each of the opposite ends of the cylinder having a coaxial hole and the At least one of the ends contains an internal thread for connection to the nut and/or screw of the bone screw or for connection to a rod section or plate, wherein in particular both ends each have an internal thread. the
该发明还涉及用于骨和椎骨稳固装置中的弹性元件,它大致是一个含有第一端及与其相反的第二端的圆柱体,所述圆柱体第一端含有带有外螺纹的圆柱形突出物用于连接到骨螺钉的螺帽或螺杆、用于连接到杆区段或者用于连接到板。 The invention also relates to an elastic element for use in bone and vertebral stabilization devices, which is generally a cylinder having a first end and an opposite second end, said cylinder first end having a cylindrical protrusion with an external thread material for connection to the nut or shank of a bone screw, for connection to a stem section, or for connection to a plate. the
所述圆柱体第二端含有一个带有外螺纹的圆柱形突出物用于连接到骨螺钉的螺帽或螺杆、用于连接到杆区段或者用于连接到板。 The second end of the cylinder contains an externally threaded cylindrical protrusion for connection to the nut or shank of a bone screw, for connection to a stem section or for connection to a plate. the
根据又一优选的实施例,所述弹性元件包含有与第二端相邻的一个同轴膛孔和/或至少在同轴膛孔与第二端相邻的区段处包含有内螺纹用于连接到骨螺钉的螺帽或螺杆、用于连接到杆区段或者用于连接到板。 According to yet another preferred embodiment, said elastic element comprises a coaxial bore adjacent to the second end and/or at least in the section of the coaxial bore adjacent to the second end, an internal thread is provided. For connection to a nut or shank of a bone screw, for connection to a rod section, or for connection to a plate. the
根据又一优选的实施例,所述弹性元件的特征是膛孔贯穿全长,和/或所述圆柱体为带有连续性同轴膛孔的管状并具有在圆柱体轴线方向上以螺旋形式延伸的壁内凹陷,其中所述凹陷在径向上止于膛孔处。 According to yet another preferred embodiment, the elastic element is characterized by a bore running through its entire length, and/or the cylinder is tubular with a continuous coaxial bore and has a helical shape in the direction of the axis of the cylinder. An extended in-wall recess, wherein the recess terminates radially at the bore. the
根据又一优选的实施例,所述弹性元件的特征是膛孔内设置有芯和/或者弹性元件形成为螺旋形弹簧。 According to yet another preferred embodiment, the elastic element is characterized in that a core is arranged in the bore and/or the elastic element is formed as a helical spring. the
根据又一优选的实施例,所述弹性元件用生物相容性材料特别 是钛制成。 According to another preferred embodiment, the elastic element is made of biocompatible material, especially Is made of titanium. the
该发明特别涉及带有如前面所述的弹性元件的骨锚固元件,包含了与弹性元件一端连接的带有骨螺纹的螺杆和与弹性元件另一端连接的骨螺钉的端片最好是螺帽。 The invention particularly relates to a bone anchoring element with an elastic element as described above, comprising a bone threaded screw rod connected to one end of the elastic element and a bone screw end piece preferably a nut connected to the other end of the elastic element. the
该发明特别涉及用于连接两个骨锚固元件的杆状元件,该杆状元件带有一个弹性元件和与弹性元件一端相连的第一刚性杆区段,其中特别是有第二刚性杆区段与弹性元件另一端相连。 The invention relates in particular to a rod-shaped element for connecting two bone anchoring elements, the rod-shaped element having an elastic element and a first rigid rod section connected to one end of the elastic element, in particular a second rigid rod section Connect to the other end of the elastic element. the
该发明特别涉及一种板,它至少在其一端有一个带有外螺纹的圆柱形突出物或者有一个带有内螺纹状的膛孔,用于连接上面所述的柔性或弹性元件。 The invention relates in particular to a plate having, at least at one end thereof, a cylindrical protrusion with an external thread or a bore with an internal thread for the attachment of the above-mentioned flexible or elastic element. the
该发明特别涉及一种用于骨、骨部件或脊柱的动态稳定的稳固装置,带有通过如前所述的杆状元件互相连接的至少两个骨锚固元件。 The invention relates in particular to a stabilization device for the dynamic stabilization of bones, bone parts or the spine with at least two bone anchoring elements interconnected by a rod-shaped element as described above. the
该发明特别涉及弹性元件的一种制作方法,包括以下几个步骤: This invention particularly relates to a kind of manufacturing method of elastic element, comprises the following several steps:
(a)准备一个管状体或 (a) Prepare a tubular body or
(b)准备一个圆柱形的物体; (b) prepare a cylindrical object;
(c)通过从外侧沿延伸方向与圆柱体或管状体的主轴同轴的螺旋形以金属切削方式去除材料的方法形成螺旋形凹陷; (c) forming helical depressions by metal-cutting material removal in a helical form coaxial with the major axis of the cylindrical or tubular body from the outside in the direction of extension;
(d)沿着圆柱体的主轴形成一个膛孔; (d) forming a bore along the major axis of the cylinder;
(e)在管状体或者膛孔的两个端部区段中的一个内形成内螺纹; (e) forming an internal thread in one of the two end sections of the tubular body or bore;
其中步骤(d)中膛孔的内直径选择成使步骤(c)中利用金属切削形成的圆柱体外侧壁上的螺旋形凹陷在径向上止于膛孔,特别是在膛孔的另外一个端部区段中形成内螺纹。 wherein the inner diameter of the bore in step (d) is selected such that the helical depression on the outer wall of the cylinder formed by metal cutting in step (c) ends radially in the bore, particularly at the other end of the bore Internal threads are formed in the upper section. the
该发明特别涉及弹性元件的一种制作方法,包括以下几个步骤: This invention particularly relates to a kind of manufacturing method of elastic element, comprises the following several steps:
(a)准备一个圆柱体; (a) prepare a cylinder;
(b)用金属旋转切削的方法在圆柱体两端的每一端形成带有外螺纹的圆柱形突出物; (b) forming a cylindrical protrusion with external threads at each of the two ends of the cylinder by metal rotary cutting;
(c)通过从外侧沿延伸方向与圆柱体主轴同轴的螺旋形以金属 切削方式去除材料的方法形成螺旋形凹陷; (c) Metal through a helical shape coaxial with the main axis of the cylinder along the direction of extension from the outside The method of removing material by cutting forms a helical depression;
(d)沿圆柱体主轴方向形成一个膛孔,特别是还包括以下步骤: (d) forming a bore along the major axis of the cylinder, in particular including the steps of:
(f)在形成膛孔后通过磨削精加工螺旋形凹陷的尾部,以除去在膛孔内侧上的尖锐边缘;和 (f) finishing the tail of the helical depression by grinding after forming the bore to remove sharp edges on the inside of the bore; and
(g)为这样制成的弹性元件清理毛刺。 (g) Deburring the elastic member thus produced. the
该发明特别涉及弹性元件的一种制作方法,包括以下几个步骤: This invention particularly relates to a kind of manufacturing method of elastic element, comprises the following several steps:
(a)准备一个带有第一和第二端的管状体; (a) preparing a tubular body with first and second ends;
(b)准备一个带有第一和第二端的圆柱体并形成与圆柱体的主轴同轴的膛孔,所述膛孔至少应与圆柱体第一端相邻; (b) preparing a cylinder with first and second ends and forming a bore coaxial with the major axis of the cylinder, said bore being adjacent at least the first end of the cylinder;
(c)沿延伸方向与圆柱体主轴同轴的螺旋采用线切割放电加工、激光处理或水刀处理切削出凹陷; (c) The helix coaxial with the main axis of the cylinder along the extension direction is cut out by wire-cut electric discharge machining, laser treatment or water jet treatment;
(d)或者在圆柱体的第一端采用金属旋转切削形成一个直径小于步骤(a)中管状体或(b)中圆柱体的预定外径的圆柱形突出物,并且在该圆柱形突出物表面形成外螺纹,或者在邻近圆柱体或管状体第一端区段的膛孔内形成内螺纹,其中特别是步骤(b)中形成的膛孔从圆柱体的第一端延伸到第二端。 (d) or form a cylindrical protrusion with a diameter smaller than the predetermined outer diameter of the tubular body in step (a) or the predetermined outer diameter of the cylinder in step (b) by metal rotary cutting at the first end of the cylinder, and externally threaded on the surface, or internally threaded in a bore adjacent to the first end section of the cylindrical or tubular body, wherein in particular the bore formed in step (b) extends from the first end to the second end of the cylindrical body . the
根据再一个优选的实施例,该方法还包括在邻近圆柱体第二端区段的膛孔内形成内螺纹的步骤。 According to a further preferred embodiment, the method further comprises the step of forming an internal thread in the bore adjacent the second end section of the cylindrical body. the
根据再一个优选的实施例,上述方法还包括下面的步骤:在圆柱体或管状体的第二端,通过金属旋转切削形成直径小于圆柱体或管状体预定外直径的第二圆柱形突出物,并且在该第二圆柱形突出物表面形成外螺纹。 According to yet another preferred embodiment, the above method further comprises the following steps: at the second end of the cylinder or the tubular body, forming a second cylindrical protrusion with a diameter smaller than the predetermined outer diameter of the cylinder or the tubular body by metal rotary cutting, And an external thread is formed on the surface of the second cylindrical protrusion. the
该发明特别涉及弹性元件的一种制作方法,包括以下几个步骤: This invention particularly relates to a kind of manufacturing method of elastic element, comprises the following several steps:
(a)准备一个带有第一端和第二端的圆柱体或管状体; (a) preparing a cylindrical or tubular body with a first end and a second end;
(b)在圆柱体上的第一端和第二端,通过金属旋转切削形成一个直径小于步骤(a)中圆柱体或管状体的预定外直径的圆柱形突出物,并且在该圆柱形突出物表面形成外螺纹;以及 (b) At the first end and the second end of the cylinder, a cylindrical protrusion having a diameter smaller than the predetermined outer diameter of the cylinder or tubular body in step (a) is formed by metal rotary cutting, and the cylindrical protrusion external threads formed on the surface of the object; and
(c)沿延伸方向与该圆柱体主轴同轴的螺旋,通过线切割放电加工、激光处理或水刀处理切削出凹陷,其中特别是螺旋形凹陷的两 个尾部为1/4圆的形式。 (c) The helix coaxial with the main axis of the cylinder along the direction of extension, the depressions are cut by wire-cut electric discharge machining, laser treatment or water jet treatment, especially the two sides of the helical depressions The tail is in the form of a 1/4 circle. the
附图说明 Description of drawings
通过下面结合附图对两个具体实施例的详细描述,本发明进一步的优点、特性和特征将变得更明显。附图的显示纯粹是示意性的。 Further advantages, features and features of the present invention will become more apparent through the following detailed description of two specific embodiments in conjunction with the accompanying drawings. The drawings shown are purely schematic. the
图1椎骨或椎间盘的间隔支撑器的三维视图; Figure 1 Three-dimensional view of the spacer supporter of the vertebra or intervertebral disc;
图2图1中的间隔支撑器的侧视图; A side view of the spacer support in Figure 2 Figure 1;
图3图1和图2中的间隔支撑器的详细侧视图; Figure 3 is a detailed side view of the spacer support in Figures 1 and 2;
图4a)-c)另一种间隔支撑器的视图; Fig. 4a)-c) the view of another kind of spacer supporter;
图5a)-c)第三种间隔支撑器的视图; Fig. 5a)-c) the view of the third spacer support;
图6a)-c)本发明的物体的制造阶段; Figure 6a)-c) stages of manufacture of objects of the invention;
图7带有一连接杆的两个椎弓根螺钉装置和间隔支撑器的三维视图; Figure 7. Three-dimensional view of two pedicle screw devices and spacer support with a connecting rod;
图8其间布置有间隔支撑器并且通过带弹性连接杆的椎弓根螺钉装置进行侧向固定的相邻椎骨的三维视图; Figure 8 is a three-dimensional view of adjacent vertebrae with spacer supports arranged therebetween and laterally fixed by a pedicle screw device with elastic connecting rods;
图9本发明中带有杆状部件的稳固装置的三维示意图; Fig. 9 is a three-dimensional schematic diagram of a stabilizing device with rod-shaped parts in the present invention;
图10图9中杆状部件的三维图; The three-dimensional diagram of rod-shaped part in Fig. 10 Fig. 9;
图11a图9中杆状部件的侧视图; A side view of the rod-shaped part in Fig. 11a Fig. 9;
图11b图9中杆状部件的剖视图; The cross-sectional view of the rod-shaped part in Fig. 11b Fig. 9;
图12a杆状部件和骨锚固部件之间连接的三维视图; A three-dimensional view of the connection between the rod-shaped part and the bone anchoring part of Fig. 12a;
图12b杆状部件和骨锚固部件之间连接的剖视图; The cross-sectional view of the connection between the rod-shaped part and the bone anchoring part of Fig. 12b;
图13另一种实施例中的杆状部件的侧视图; The side view of the rod-shaped part in another kind of embodiment of Fig. 13;
图14又一种实施例中的杆状部件的侧视图; The side view of the rod-shaped part in another embodiment of Fig. 14;
图15图14中杆状元件旋转90度后的侧视图; The side view of the rod-shaped element rotated 90 degrees in Fig. 15 and Fig. 14;
图16再一种实施例中的杆状元件的三维视图; A three-dimensional view of the rod-shaped element in another embodiment of Fig. 16;
图17图16中杆状部件的侧视图; The side view of the rod-shaped part in Fig. 17 Fig. 16;
图18还一种实施例中的杆状部件的剖视图; Figure 18 is also a cross-sectional view of the rod-shaped part in an embodiment;
图19本发明中带有一个杆状部件的稳固装置的使用; Use of a stabilizing device with a rod-shaped part among Fig. 19 the present invention;
图20图19中杆状部件的侧视图; The side view of the rod-shaped part in Fig. 20 Fig. 19;
图21图19中带有一个杆状部件的稳固装置的另一种使用状 态的三维视图; Another use state of the stabilizing device with a rod-shaped part among Fig. 21 Fig. 19 3D view of state;
图22图21中杆状部件的侧视图; The side view of the rod-shaped part in Fig. 22 Fig. 21;
图23稳固装置的另一种应用; Another application of the stabilizing device in Figure 23;
图24稳固装置的又一种应用示例; Another application example of Fig. 24 stabilizing device;
图25a弹性杆状部件又一种实施例的侧视图; A side view of another embodiment of the elastic rod-shaped part of Fig. 25a;
图25b图25a中弹性杆状部件的剖视图; The cross-sectional view of the elastic rod-shaped part in Fig. 25b Fig. 25a;
图26a弹性杆状部件的第一种应用示例; The first application example of the elastic rod-shaped part of Fig. 26a;
图26b图26a中杆状部件的修改形式; Modification of the rod-shaped part in Fig. 26b Fig. 26a;
图27带有图25a和25b中弹性杆状部件的骨锚固部件; Fig. 27 has the bone anchoring part of elastic rod-shaped part in Fig. 25a and 25b;
图28一个由两个三件式骨锚固部件和一个杆状部件组成的稳固装置,其中每个部件都包含一个弹性部件; Figure 28 A stabilization device consisting of two three-piece bone anchoring components and a rod-like component, each of which includes an elastic component;
图29弹性杆状部件又一种实施例的侧视图; A side view of another embodiment of the elastic rod-shaped part of Fig. 29;
图30弹性杆状部件再一种实施例的侧视图; A side view of another embodiment of the elastic rod-shaped part of Fig. 30;
图31a弹性杆状部件还一种实施例的侧视图; The side view of another embodiment of Fig. 31a elastic rod-shaped part;
图31b图31a中弹性杆状部件旋转90度后的侧视图; The side view of the elastic rod-shaped part rotated 90 degrees in Fig. 31b Fig. 31a;
图32弹性杆状部件的剖视图; The sectional view of Fig. 32 elastic rod-shaped part;
图33本发明又一实施例中的弹性杆状部件; The elastic rod-shaped part in another embodiment of the present invention in Fig. 33;
图34本发明再一实施例中的弹性杆状部件; The elastic rod-shaped part in another embodiment of the present invention in Fig. 34;
图35a包含一个杆状部件、一个本发明中的弹性部件和一个板的结合部件的分解图; Figure 35a comprises an exploded view of a rod-shaped part, an elastic part of the present invention and a combination part of a plate;
图35b图35a中的板沿A-A线的剖视图; Figure 35b is a cross-sectional view of the plate along the A-A line in Figure 35a;
图36图35a和图35b中板的应用示例,其中所述板和通过弹性部件连接到该板的杆状部件通过骨锚固部件锚固在椎骨上。 Figure 36 Example of application of the plate in Figures 35a and 35b, wherein the plate and the rod-shaped part connected to the plate by elastic means are anchored to the vertebrae by means of bone anchoring means. the
图37a本发明的弹性杆状部件在用于髋骨的动态稳固装置中的应用; The application of the elastic rod-shaped part of the present invention in the dynamic stabilization device for the hip bone of Fig. 37a;
图37b应用在图37a中的稳固装置上的骨锚固部件的剖视图; Figure 37b is applied to the cross-sectional view of the bone anchoring component on the stabilizing device in Figure 37a;
图38本发明中用线切割放电加工、激光处理或水刀处理制成的弹簧部件。 Fig. 38 is a spring component made by wire-cut electrical discharge machining, laser treatment or water jet treatment in the present invention. the
具体实施方式 Detailed ways
图1所示为一个本发明植入物第一种实施例的三维图示,该植入物作为一个间隔支撑器,用于椎骨或椎间盘。间隔支撑器10具有一个圆柱体1和两个位于该圆柱体1端部的连接部件2,该连接部件用于把间隔支撑器10连接到其相邻机体部位,例如在比如人体中的骨头或软骨。
Figure 1 shows a three-dimensional representation of a first embodiment of the implant of the present invention as a spacer support for a vertebra or intervertebral disc. The spacer support 10 has a cylinder 1 and two connecting
在图示的举例性实施例中布置在圆柱体1各个端部的连接部件2具有同样的形状,但也可以是不同的形状。连接部件2在端部的各个自由端上具有锯齿状突起3,该突起能够在植入位置与相邻的机体组织相嵌合。
The connecting
间隔支撑器10两端的锯齿状突起3通过三角形凹陷5形成,从而使梯形的锯齿状突起3能嵌合固定在相邻机体组织内。 The saw-toothed protrusions 3 at both ends of the spacer support 10 are formed by triangular recesses 5, so that the trapezoidal saw-toothed protrusions 3 can be fitted and fixed in adjacent body tissues. the
此外,连接部件2具有菱形镂空4(见图2),并设置成使它们在连接部件2的整个圆柱体外表面彼此相邻。结果,各个连接部件自身又通过许多的菱形互连框条6形成,且框条6形成的菱形末端切掉而形成了梯形的锯齿状突起3。
Furthermore, the
在图示的实施例中,圆柱体各端的连接部件2之间的管状体1具有螺旋形材料凹陷7,所以壁11(见图3)本身形成为螺旋形。由于间隔支撑器10在整体上形成为中空圆柱体,所以即便间隔支撑器10自身是由本来刚硬的材料诸如钛或者钛合金构成的,连接部件2之间带有材料凹陷7的管状体1成为一个弹性区域或者活动区域。间隔支撑器10通过材料凹陷7在管状体1区域就获得了一种设计相关的弹性,这样就可能无需在这个区域里使用单独的弹性材料而获得单独的弹性或活动性。特别是,这可以避免不得不以多个需要组合在一起的部件来制造间隔支撑器。
In the illustrated embodiment, the tubular body 1 between the connecting
通过螺旋形材料凹陷7,方便地获得了管状体1在间隔支撑器10沿纵向轴线9上的可延展性和可压缩性以及绕比如轴线8所示(图2)的、垂直于长轴9的旋转轴上的可弯曲性。这里,特别是材料凹陷7的螺旋形状发挥了作用,它便于在最可能多的方向上获得平稳匀 衡的弹性或者活动性。然而,自然能够想到并且也可以根据个案所采用的解决方案或可能的负载情况采用其他形状的材料凹陷以及不同数量和排列的这类材料凹陷。 The extensibility and compressibility of the tubular body 1 along the longitudinal axis 9 of the spacer support 10 and around the longitudinal axis 9 perpendicular to the major axis 9 as indicated by the axis 8 ( FIG. 2 ) is conveniently obtained by means of the helical material depression 7 Bendability on the axis of rotation of . Here, in particular, the helical shape of the material depression 7 plays a role, which facilitates a smooth and even surface in as many directions as possible. Balanced elasticity or mobility. However, other shapes of material depressions and different numbers and arrangements of such material depressions are naturally conceivable and can also be used depending on the individual solution or possible load situations. the
图4的子图a)到c)是带有管状体101的间隔支撑器100的第二种实施例的三个不同的图即三维分解图(a)、(c)及三维截面图(b),该管状体101在下侧用与管状体101连成整体的端板125封住,从而形成一个烧杯状。 Sub-figures a) to c) of Fig. 4 are three different figures, i.e. three-dimensional exploded views (a), (c) and three-dimensional cross-sectional views (b) of the second embodiment of the spacer 100 with the tubular body 101 ), the tubular body 101 is sealed at the lower side with an end plate 125 integrally connected with the tubular body 101, thereby forming a beaker shape. the
管状体101在其壁111上具有根据本发明带给该管状体101一定弹性的螺旋状凹陷107。 The tubular body 101 has on its wall 111 helical depressions 107 which, according to the invention, impart a certain elasticity to the tubular body 101 . the
为了能准确调整间隔支撑器100的刚度,在管状体101的内部提供了一种由弹性材料制成的可替换的芯部件130,该芯部件通过端板125从下部、端板126从上部固定在管状体101中。 In order to be able to precisely adjust the stiffness of the spacer support 100, inside the tubular body 101 there is provided a replaceable core part 130 made of elastic material, which is fixed from the bottom by the end plate 125 and from the top by the end plate 126 In the tubular body 101 . the
间隔支撑器上侧的端板126有外螺纹127,通过该外螺纹它可以旋入到管状体101内侧上端处管状体101的内螺纹128,端板126有一个肩部使它紧盖在壁111上。锯齿状突起103设置在壁111端部的整个圆周上并伸过端板125和端板126从而能与相邻组织相嵌合,以便使间隔支撑器能在那牢固定位。 The end plate 126 on the upper side of the spacer has an external thread 127, through which it can be screwed into the internal thread 128 of the tubular body 101 at the inner upper end of the tubular body 101. The end plate 126 has a shoulder to make it tightly cover the wall. 111 on. Serrations 103 are provided over the entire circumference of the ends of wall 111 and extend through end plates 125 and 126 to engage adjacent tissue to securely position the spacer support there. the
端板126上有连接孔129,以便能把端板126拧入管状体101中。 The end plate 126 has connection holes 129 so that the end plate 126 can be screwed into the tubular body 101 . the
图5在子图a)到c)中所示为间隔支撑器的第三种实施例;其中子图a)和c)是三维分解图,而子图b)所示为三维剖视图。在图5的实施例中,管状体201在壁211上也具有螺旋形凹陷207。 Figure 5 shows a third embodiment of a spacer support in sub-figures a) to c); where sub-figures a) and c) are three-dimensional exploded views, and sub-figure b) a three-dimensional cross-sectional view. In the embodiment of FIG. 5 , the tubular body 201 also has a helical depression 207 on the wall 211 . the
管状体201在下侧处也由一个形成一体的端板225封住,这样又形成了烧杯装的管状体201。诚然,端板225的外径做得比其中设置有螺旋状材料凹陷207的管状体201的大。因此形成了一个肩部,使由弹性材料制成的管状套筒230有了一个端座。弹性套筒230套在管状体201上并完全环绕它。在上端,端板226通过螺纹连接旋到管状体201上。这里,端板226的外螺纹227与管状体201的内螺纹228啮合,从而使套筒230紧紧固定在端板225和端板226之间。套 筒230也用于调整整体的刚性,其中通过类似于更换芯部130(见图4)的方式简单地更换套筒230,来简单地改变植入物100和200整体的刚性。 The tubular body 201 is also closed at the underside by an integrally formed end plate 225, which in turn forms the tubular body 201 in a beaker. Admittedly, the outer diameter of the end plate 225 is made larger than that of the tubular body 201 in which the helical material recess 207 is provided. A shoulder is thus formed, giving an end seat to the tubular sleeve 230 made of elastic material. The elastic sleeve 230 fits on the tubular body 201 and completely surrounds it. At the upper end, an end plate 226 is screwed onto the tubular body 201 by means of a screw connection. Here, the external thread 227 of the end plate 226 is engaged with the internal thread 228 of the tubular body 201 , so that the sleeve 230 is tightly fixed between the end plate 225 and the end plate 226 . set The sleeve 230 is also used to adjust the overall rigidity, wherein the overall rigidity of the implants 100 and 200 is simply changed by simply replacing the sleeve 230 in a manner similar to replacing the core 130 (see FIG. 4 ). the
端板225及端板226上设有角锥形的锯齿状突起203用来与周围组织相嵌合并牢固锚定间隔支撑器。 The end plates 225 and 226 are provided with pyramid-shaped serrations 203 for fitting with surrounding tissues and firmly anchoring the spacer support. the
盖226同样也有连接孔229,用来将端板226旋到管状体201上。 The cover 226 also has attachment holes 229 for screwing the end plate 226 onto the tubular body 201 . the
图6所示为激光束331如何能通过激光处理简单地在管件301上形成材料凹陷307和337的例子。 Figure 6 shows an example of how a laser beam 331 can easily create material depressions 307 and 337 in a tube 301 by laser processing. the
从图6的子图a)可见,而且从平面图中看特别明显,首先用激光束331钻穿管件301以形成332和333两个开口;接着,如图6b)所示,在旋转管件301的同时沿箭头方向推进,就能形成从开口332开始的凹陷307和从开口333开始的凹陷337。结果形成了两道平行的材料凹陷,从而形成了布置成相互嵌含、成对并行、双螺距的螺旋状弹簧或者螺旋弹簧区域。 It can be seen from the sub-figure a) of Fig. 6, and it is particularly obvious from the plan view that at first the laser beam 331 is used to drill through the pipe 301 to form two openings 332 and 333; then, as shown in Fig. Simultaneously advancing in the direction of the arrow, the depression 307 starting from the opening 332 and the depression 337 starting from the opening 333 can be formed. The result is two parallel indentations of the material, thereby forming helical springs or helical spring regions arranged in nested, parallel pairs, double pitch. the
图7所示为本发明中弹性植入物的又一实施例。图7中用三维图显示了通过连接杆20相互连接、带有对应的椎弓根螺钉13、15的两个椎弓根螺钉装置12和14。连接杆20,更准确的说是在位于固定区域16、17之间的弹性或活动区域18位置,被设计成弹性植入物,其中连接杆通过椎弓根螺钉装置支撑。 Fig. 7 shows another embodiment of the elastic implant of the present invention. Two pedicle screw arrangements 12 and 14 with corresponding pedicle screws 13 , 15 are shown in three-dimensional view in FIG. 7 , connected to each other by a connecting rod 20 . The connecting rod 20, more precisely at the elastic or mobile region 18 located between the fixation regions 16, 17, is designed as an elastic implant in which the connecting rod is supported by means of a pedicle screw arrangement. the
连接杆20的弹性区域18中设有螺旋形材料凹陷19,该凹陷围绕连接杆20的纵向轴21延伸。 In the elastic region 18 of the connecting rod 20 there is provided a helical material recess 19 which extends around the longitudinal axis 21 of the connecting rod 20 . the
由于连接杆20设计为中空圆柱体,弹性区域18实际上也就成螺旋形。 Since the connecting rod 20 is designed as a hollow cylinder, the elastic region 18 is actually also helical. the
为了制作出如图7中所示的本发明连接杆,可以使用由生物相容性材料如钛合金构成的实心圆柱形或杆状。首要的步骤是在特定区域即弹性区域18内通过机械加工或化学蚀刻或者通过激光处理在这个实心杆中形成材料凹陷19。这种连接杆就会在弹性区域18有更大 的弹性并能这样使用。 In order to make the connecting rod of the present invention as shown in Fig. 7, a solid cylindrical or rod shape made of a biocompatible material such as a titanium alloy can be used. The first step is to create a material recess 19 in this solid rod by machining or chemical etching or by laser treatment in a specific area, namely the elastic area 18 . This connecting rod will have bigger in elastic area 18 flexibility and can be used in this way. the
通过机械或化学方法在连接杆20的纵向轴21上形成膛孔并使连接杆20形成中空圆柱体状或管状,可以进一步提高区域18的弹性或活动性。 The elasticity or mobility of the region 18 can be further enhanced by mechanically or chemically forming a bore in the longitudinal axis 21 of the connecting rod 20 and forming the connecting rod 20 into a hollow cylindrical or tubular shape. the
如果膛孔的直径选成使连接杆杆所留壁的厚度小于原先形成的材料凹陷19的深度,那么在弹性区域18中的就不是槽状凹陷而是开孔,这实际上也就成螺旋形。虽然最后提到的这种形状是优选实施例,但先前提到的仅仅带有材料凹陷的形状即中空体的槽状凹陷或其它结构也是可以作为替代。 If the diameter of the bore is selected so that the thickness of the wall left by the connecting rod is less than the depth of the material depression 19 formed originally, then in the elastic region 18 it is not a groove-like depression but an opening, which is actually a spiral shape. Although this last-mentioned shape is a preferred embodiment, the previously mentioned shapes with only material depressions, ie groove-like depressions of hollow bodies or other structures are also possible as an alternative. the
图8所示为这两个实施方式例子的应用,即在两个椎骨22、23之间布置间隔支撑器10以及在位于人体脊柱上的椎弓根螺钉装置12、14之间设置弹性连接杆20。从这个图中可以容易地看到,特别是在联合应用的情况下,植入物的弹性结构使脊柱相应区域具有了一定的活动性,这将明显增加患者的舒适感。 Figure 8 shows the application of these two embodiment examples, namely the placement of a spacer support 10 between two vertebrae 22, 23 and the provision of an elastic connecting rod between pedicle screw arrangements 12, 14 on the human spine 20. From this figure it can be easily seen that, especially in the case of combined application, the elastic structure of the implant allows a certain mobility in the corresponding area of the spine, which will significantly increase the comfort of the patient. the
图19到38显示了弹性植入物,特别是脊柱稳固装置中的连接杆的更多实施例和应用范围。 Figures 19 to 38 show further embodiments and areas of application of elastic implants, especially connecting rods in spinal stabilization devices. the
从图9中可见,所示应用中的这个稳固装置包括一个杆状部件401和通过该杆状部件相互连接的两个椎弓根螺钉402、403。椎弓根螺钉402、403锚固在其间椎间盘406受损的两个相邻椎骨404、405的椎弓根中。
As can be seen in Figure 9, this stabilization device in the application shown comprises a rod-shaped
本发明中的杆状部件401形成为一体。根据如图10、11a和11b所示的第一个实施例,它包括从杆状部件第一端开始、具有预定长度的第一刚性区段407,从杆状部件的第二端开始、具有预定长度的第二刚性区段408,以及在刚性区段407、408之间具有预定长度的弹性区段409,且所有区段的外直径是相同的。此外,具有预定直径的同轴膛孔410贯穿杆状部件。弹性区段409形成为一个带有预定螺距的螺纹411的螺旋弹簧。弹性区段409的螺纹411沿杆状部件纵向轴A方向的高度、决定螺纹411径向厚度的同轴膛孔410直径以及螺距
选择成使杆状部件411对在受到轴向力、弯曲力、扭矩力具有所需的刚性。
The
从图9、12a和12b中可见,稳固装置的椎弓根螺钉402、403如已知的那样有一个带有骨螺纹的螺杆412和一个带有用来插入杆状部件的U形凹陷415、基本上呈圆柱形的端座413。如已知的那样设置能旋入端座的内置螺钉414以把刚性区段407、408固定在端座413上。椎弓根螺钉最好制成多轴螺钉。杆状部件401刚性区段407、408的轴向长度和直径的尺寸确定成使带有刚性区段407、408的杆状部件401能连接到椎弓根螺钉402、403上。所以刚性区段407、408的长度与用来固定杆状部件的内置螺钉414的直径至少大致相当。对于椎弓根螺钉420的端座413′来说,由于杆状部件不是从上部插入而是在开口421处横向推入,所以刚性区段的长度也要与在端座413处固定杆状部件的内置螺钉414的直径至少大致相当。
As can be seen from Figures 9, 12a and 12b, the pedicle screws 402, 403 of the stabilizing device have, as known, a
在图9所示的稳固装置的例子中,杆状部件401的弹性区段409的长度选择成与在椎间盘406无负载状态下椎弓根螺钉402、403的间距大致相当,但弹性区段409也可是更长或者更短。
In the example of the stabilizing device shown in Figure 9, the length of the
杆状部件401由生物相容性材料制成,比如钛或生物相容性塑料,然而这类材料没有或仅有少许弹性。
The
在手术过程中,首先将椎弓根螺钉402、403、420旋入与椎弓根相邻的椎骨中,然后杆状部件401及其刚性区段407、408分别插入椎弓根螺钉402、403、420的端座(接收部件)413、413′之一内。在确定椎骨404、405的相对位置以及调整椎弓根螺钉402、403、420与杆状部件的相对位置后,将刚性区段407、408固定在端座413、413′内。椎骨404、405的相对位置确定成杆状部件401的弹性区段409在椎间盘406无负载状态下处于松弛状态。当有负载时,受力经由椎骨和椎间盘装置后作用在椎间盘406上。杆状部件401通过弹性区段409限制了椎骨相互之间的多轴运动,由此避免了椎间盘的过大受力。这样就能防止轻度或中度缺陷椎间盘的情况恶化。作为另一种选择,可根据需要在脊柱无负载状态下通过稳固装置实行预设的椎骨
牵引,以通过这种方法减轻椎间盘负载。作为再一种选择,还可根据需要直接把骨螺钉从侧向锚入椎骨中。
During the procedure, the pedicle screws 402, 403, 420 are first screwed into the vertebra adjacent to the pedicle, and then the
在图13所示的实施例中,与前面的实施例一样,一个杆状部件500包含刚性区段507、508和一个与它们连成一体的、螺旋弹簧形式的弹性区段590,其中弹性区段590在刚性区段507、508之间。它与第一个实施例不同的是,弹性区段590的直径比刚性区段507、508的直径大。这样一来,获得的刚性也比第一个实施例中杆状部件的刚性要大。手术过程如第一个实施例中所述。
In the embodiment shown in FIG. 13, as in the previous embodiments, a
图14和15所示为再一个实施例中的杆状部件501。与前面实施例中的杆状部件401、500不同的是,设置在刚性区段507、508之间的弹性区段591具有两个区域592,这两个592区域互相偏离180度并凹向杆轴线。区域592在杆轴线方向上的长度L最大为弹性区段592的长度,并且曲率半径设置成使螺旋弹簧的螺纹不至于被中断。结果这种结构使得弹性区段591在与杆轴线A相垂直的轴方向B上形成较窄的腰部从而在该方向上刚度较小。结果就获得对于某些应用来说是有利的定向刚性。
Figures 14 and 15 show a
手术过程如前述实施例情况所述,唯一的不同是杆状部件501能以在圆周方向上定向的方式连接到椎弓根螺钉内。通过选择弹性区段的尺寸可以准确地选择、设定所需的刚度。
The surgical procedure is as in the case of the previous embodiment, the only difference being that the
图16、17中所示的又一实施例中,杆状部件502具有一个贯穿其弹性区段593的同轴圆柱形芯511,所述芯具有一定的弯曲弹性。芯511的直径设置成使芯在推入膛孔510后能恰当地卡住而固定。芯最好采用与杆状部件相同的材料,但也可以采用弹性塑料。
In yet another embodiment shown in Figures 16 and 17, the rod-shaped
在一种设计变体中,芯511与到刚性区段507、508以及弹性区段593的螺旋弹簧的螺纹连接成一体。
In a design variant, the
与前面的实施例相比,芯511使杆状部件502具有更大的弯曲刚度。所以,在这个实施例中,能获得与具有更大弹性区段直径的杆状部件500类似的刚性。通过芯的直径和/或材料的选择能进一步调
整弯曲刚度。
The
手术过程如前面实施例情况下一样进行。但与前面实施例不同的是,弹性区段593在轴向上的压缩或延展以及扭矩在尺寸上都变小。特别是只允许弯曲运动,这对于某些应用来说是有利的。
The surgical procedure was carried out as in the case of the previous example. However, different from the previous embodiments, the
在图18所示的另一种实施例中,杆状部件503同前面实施例一样有刚性区段507、508和一个弹性区段590。在同轴膛孔510中设有一个通过固定部件如夹紧螺钉513以拉紧状态固定在刚性区段507、508上的可拉伸部件512例如金属丝。在手术中,这可以在弹性区段590上加上预应力。
In another embodiment shown in FIG. 18, the
所述各个实施例的技术特征可以相互结合。比如,杆状部件501也能有芯和/或用来获得定向刚性的特定形状区段。在实施例502的一个设计变体中,弹性区段在一个位置形成均匀较窄的腰部或者在圆周上设置间隔均匀的几个凹陷区域,以在限定的方向上获得一定的刚性。
The technical features of the various embodiments can be combined with each other. For example, the
在另一个实施例中,杆状部件有与若于个弹性区段对应的若于个刚性区段,并且每个弹性区段都位于刚性区段之间,使得许多的椎弓根螺钉都能部分刚性部分弹性地互相连接。 In another embodiment, the rod member has several rigid sections corresponding to several elastic sections, and each elastic section is located between the rigid sections, so that many pedicle screws can The partially rigid sections are elastically interconnected. the
在还一个实施例中,弹性区段的周围设置由生物相容性材料制成的覆盖层或保护性外套,以防止组织、血管或其他机体材料夹入螺纹中而导致受伤或者杆状部件功能的损坏。 In yet another embodiment, the resilient section is surrounded by a covering or protective sheath of biocompatible material to prevent tissue, blood vessels, or other bodily material from being trapped in the threads and causing injury or stem member function. damage. the
而另一个实施例中,采用单轴螺钉来代替多轴螺钉,或者在稳固装置中使用一个单轴螺钉与一个多轴螺钉的组合或多个这些螺钉的组合。同样可以想到用钩来代替骨螺钉。在又一实施例中,刚性区段和/或弹性区段是弯曲的。 In yet another embodiment, a uniaxial screw is used instead of a polyaxial screw, or a combination of a uniaxial screw and a polyaxial screw or a combination of several of these screws are used in the stabilization device. It is also conceivable to use hooks instead of bone screws. In yet another embodiment, the rigid section and/or the elastic section is curved. the
图19到24所示为带有杆状部件的稳固装置的几种优选应用方式。在图19到22的稳固装置中,使用带有芯511的杆状部件502。这种稳固装置用于比如轻度或中度缺陷的椎间盘506需要支撑并且需要通过限制椎骨活动来避免有害作用力作用在椎间盘上时。杆状部
件502在轴向上是刚性的,在轴向上既不允许拉长或也不允许压缩。但与杆轴呈α角比如最大为8度的弯曲运动是可以的。
Figures 19 to 24 show several preferred applications of the stabilizing device with rod-like elements. In the stabilizing device of FIGS. 19 to 22, a rod-shaped
图23所示为带有杆状部件的稳固装置在取走原生的椎间盘后用刚性部件450比如钛圆柱体连接两个椎骨404、405的情况中的应用。这里,杆需要有更大的刚度以便能获得足够的运动限制。但与完全刚性连接相比,椎体间的轻微相对运动是有好处的;因为增加循环的局部负载能刺激骨质生长并加速骨化过程。
Figure 23 shows the application of a stabilization device with a rod-shaped part in the case of connecting two
图24中显示的是动态稳固装置作为扩展连接的弹性端部的应用,其中几个在图示例子中为3个椎骨405、405′、405″通过刚性部件450相互连接并随后用刚性杆460连接。这里,与连接链的最后椎骨405和下一块椎骨404相邻接的原生椎间盘406承受了不相称的负载导致椎间盘406磨损增大。为了保护该相邻部分免受非正常运动及由此增长的负荷,稳固装置用于限制运动。在这例举的实施例中,杆状部件460具有尺寸设计成使三个椎弓根螺钉402、402′、402″能与之相连的刚性区段458。弹性区段459设置成与其相邻接,并且又在端部与一个用于连到椎弓根螺钉403的刚性区段457相邻接。
Shown in FIG. 24 is the application of a dynamic stabilization device as an elastic end of an extended connection, several of which in the illustrated example are 3
在本发明的杆状部件的制造方法中,准备好用机体相容性材料比如钛构成、具有所需直径的刚性杆。然后在杆状部件各端之间的区段内加工制成螺旋弹簧形式的弹性区段409。如果需要,钻去贯穿弹簧部件中的芯410,从而形成杆状部件401。
In the method of manufacturing a rod-shaped member of the present invention, a rigid rod of a desired diameter is prepared in a body-compatible material such as titanium. A
制造杆状部件502时,芯511留下或者随后插入另一单独的芯。
When the rod-shaped
制造杆状部件500时,准备好一个直径符合弹性区段590直径要求的杆作为原材料,然后采用例如铣工的方法制成螺旋弹簧,再把刚性端部区段507、508车成所需的直径。
When manufacturing the rod-shaped
为制造杆状部件501,在弹性区段上沿圆周方向互相偏离180度的位置的一个区域内除掉材料以便由此形成定向的腰部。
To produce the rod-shaped
图25a和25b中所示的弹性部件601包含了一个圆筒形管,该圆筒形管带有一个连续的同轴膛孔602和以具有预定螺距的螺旋形
的形式沿圆筒轴线方向在壁上延伸预定长度、在径向止于孔602的凹陷603。由此就形成了一个螺旋弹簧。圆筒轴线方向上螺旋形凹陷的长度、凹陷的高度、螺旋的螺距以及同轴膛孔的直径选择成使螺旋弹簧相对于作用在该弹簧部件上的轴向力、弯曲力和扭转力具有所需的强度。弹性部件601在其每个自由端附近都有预定长度的内螺纹604和604′。根据相应的应用选择弹性部件的外径。
The
在图26所示的第一个应用例子中,弹簧部件601是弹性杆状部件630的一个一体组成部分。弹性杆状部件630包括一个弹性部件601和两个圆柱形杆区段631、631′,每个杆区段631和631′的末端各有一个圆柱形突出物632、632′,这两个突出物上分别有可与弹性部件601上的内螺纹604、604′配合的外螺纹633、633′。在这个实施例中,杆状部件和弹性部件有基本相同的直径。杆状部件631、631′和弹簧部件601可以根据所需的应用独立选择各自的长度。例如,杆状部件用于连接脊柱上的椎弓根螺钉。由于弹簧部件601的弹性,依此制成的杆状部件630吸收压缩力、张力、弯曲力和扭转力到预定的程度。
In the first application example shown in FIG. 26 , the
图26b中所示的弹性杆状部件680与弹性杆状部件630的不同之处在于,它的第一个刚性杆区段681的外直径比弹性部件601的大而第二个刚性杆区段681′的外直径比弹性部件601的小。作为另一种选择,两个杆区段的直径可以都大于或都小于弹簧部件。
The
图27所示的是弹性部件601的第二个应用实例。从图上可以看出,弹性部件601是设置成多轴骨螺钉形式的骨锚固部件610的一个一体组成部分。该多轴骨螺钉包含一个由弹性部件601、带有这里未示出的尖端的螺杆612和螺帽613组成的螺钉部件611。
FIG. 27 shows the second application example of the
螺杆612上有骨螺纹624和圆柱形突出物625,其中骨螺纹624用于旋入骨头,圆柱形突出物625上有外螺纹与弹性部件601上的内螺纹604配合。
There are
螺帽613包含圆柱形突出物627及与其相邻的圆柱形突出物
626,与螺杆612中相似,圆柱形突出物626带有和弹性部件601上的内螺纹604′配合使用的外螺纹。
螺钉部件611嵌套于接受部位614中并可以在无负载状态下旋转。接受部位614外形大致是圆柱形的,且在它的一个末端有一个以轴对称的方向设置的第一膛孔615,该膛孔的直径比螺杆612的大但比螺帽613的小。此外,接受部位614还有一个设在与第一膛孔615相反的末端的同轴第二膛孔616,该膛孔的直径设计成使螺钉部件可以通过开口端且连同其螺杆通过第一膛孔615直到螺帽613,与第一膛孔615的边缘紧靠。接受部位614有一个T形凹陷614′,该凹陷由其自由端沿第一膛孔615方向延伸并形成两个自由腿617、618。在它们的自由端附近区域,腿617、618上有内螺纹可以和内置螺钉619的外螺纹一起用以固定杆620。
The
此外,在接受部位614中还有一个压力部件621用于固定螺帽613,该压力部件621设计成在面向螺帽613的一侧有一个球形凹陷622,该球形凹陷622的半径大致等于螺帽613的球台状区段的半径。压力部件621的外直径选择成使压力部件621可以在螺帽613方向置入接受部位614中。此外,压力部件621上还有一个同轴膛孔623,以便使旋入工具能伸入而与螺帽613上的凹陷(图上未画出)接合。
In addition, there is also a
在手术过程中,螺杆612通过其上的圆柱形突出物625旋入弹性部件601的内螺纹604,而螺帽613通过其圆柱形突出物626旋入内螺纹604′,这样就形成了螺钉部件611。螺杆612朝前,将依此制成的螺钉部件611通过第二个开孔插入接受部位614直到螺帽613和第一膛孔615的边缘紧靠。然后,压力部件621以球形凹陷朝前通过第二膛孔616进入接受部位614。然后将螺钉部件611旋入骨或椎骨。最后,将杆620置于两个腿617、618之间的接受部位614,调整接受部位相对于螺钉部件的角度位置并用内置螺钉619固定。弹性区段允许在松驰位置附近的有限度活动。
During the operation, the
多轴螺钉并不限于以上描述的实施例,而可以是任何其他带上面所述三段式螺钉部件的多轴螺钉。相应地,如果手术中在弹性部件
601和螺杆612旋入螺帽613之前先把螺帽613以圆柱形突出物626朝前通过第二膛孔616进入接受部位614,则图27所示的实施例中的第一膛孔615的直径可以比螺杆612的小。在此种情况下,只要第一膛孔615直径比圆柱形突出物626和圆柱形区段627的大就够了。作为另一种选择,螺帽613也可以没有圆柱形区段627。在此情况下,第一膛孔的直径只需足以让突出物626通过即可。
The polyaxial screw is not limited to the embodiments described above, but may be any other polyaxial screw with the three-segment screw components described above. Correspondingly, if the elastic part is
601 and the
但是,接受部位也可以设计成从下面插入螺钉部件并通过一个压力部件将螺钉部件夹在接受部位当中。在这种情况下,图27所示的膛孔615的直径应该比螺帽613的直径大。
However, the receptacle can also be designed so that the screw part is inserted from below and the screw part is clamped in the receptacle by a pressure part. In this case, the diameter of the
杆的固定并不限于图27所示的内置螺钉,而可以使用附加的外置螺帽或者其他任何已知类型的杆固定方法。 Fixing of the rod is not limited to internal screws as shown in Fig. 27, but additional external nuts or any other known type of rod fixing methods may be used. the
如果弹性部件601至少可以部分突出于骨表面,那么弹性部件601就可以吸收弯曲力以及张力和压力。当弹簧部件没有突出于骨的表面时,螺钉部件611仍可以对骨或者椎骨的运动以一定方式作出反应。这阻止了不利的紧张状态的发展。
If the
图28所示的是脊柱的稳固装置690,其中包括两个带有螺钉部件693的骨锚固部件691、691′和用于连接两个骨锚固部件的弹性杆状部件692,这些弹性杆状部件692有本发明的弹性部件601。弹性杆状部件和螺钉部件的这种多件式设计允许只用一些基本部件的组合而获得具有各种特性的稳固装置690。这个稳固装置也不一定必须包括带弹性部件的骨锚固部件和带有弹性部件的杆型部件。根据应用的领域,也可以只包含带有弹簧部件的杆型部件和带有刚性螺钉部件的骨锚固部件。
What Fig. 28 shows is the stabilizing device 690 of the spine, which comprises two bone anchoring parts 691, 691' with screw parts 693 and an elastic rod part 692 for connecting the two bone anchoring parts, these elastic rod parts 692 has the
图29所示的是弹性部件640,弹性部件640与弹性部件601的不同之处只在于长度贯穿了弹性部件全长的内螺纹641取代了两个内螺纹604、604′。
Figure 29 shows the elastic component 640. The difference between the elastic component 640 and the
图30所示的是弹性部件650。与前述的实施例不同的是该部件包括刚性末端部分651和651′以及与前面的实施例相比较少的螺旋圈 数。这可以使弹簧部件弹性的设计独立于弹簧部件的长度。 Shown in FIG. 30 is an elastic member 650 . What differs from the previous embodiments is that the part includes rigid end portions 651 and 651' and fewer helical turns than the previous embodiments number. This makes it possible to design the elasticity of the spring element independently of the length of the spring element. the
图31a和31b所示为弹簧部件660,与前述的实施例不同,其包括两个区域661,这两个区域相互偏离180度并都凹向中心轴。区域661在中心轴方向的长度L′不大于螺旋的长度L,并且区域661的曲率半径设置成不至于使螺旋弹簧的螺圈中断。由于这种设计,此弹簧部件在与中心轴相垂直的方向上有一个较窄的腰部形状,因此在该方向上刚度较小。这使弹性部件的刚度有方向性,以适合某些应用的需要。
Figures 31a and 31b show a
图32所示的弹性部件672包含有一个插入孔内的杆状芯671。一方面,此芯可以在弹性部件672受到压力的时候起到止动器的作用。另一方面,芯671可以增强弹性部件672对于弯曲力的刚度。
The
图33所示的弹簧部件760在其一端包含一个带有外螺纹的圆柱形突出物761而不是如前面实施例中的带有内螺纹的膛孔。相应的,与这个弹簧部件此端相连的部件具有带相应内螺纹的膛孔。在该弹簧部件的另一端如上述实施例中一样是一个袋状膛孔762,其有内螺纹763在该弹簧部件的该端附近。
The
图34所示是弹簧部件770,其每个末端分别有一个带有外螺纹的圆柱形突出物771、772。
Shown in Figure 34 is a
作为前述实施例的一种修改形式,弹性部件不包含连续的膛孔。 As a modification of the previous embodiment, the resilient member does not contain a continuous bore. the
作为本发明的弹性部件601的又一个应用例子,图35a所示分解图中的是连接部件700,该连接部件含有杆形部件631、弹性部件601和板701。杆形部件631上有一个带有外螺纹633的圆柱型突出物632,该外螺纹用于旋入弹性部件601一端附近的内螺纹604。板701也包括有带有外螺纹703的圆柱型突出物702,该外螺纹用于旋入位于弹性部件601的另外一端附近的内螺纹604′。该板包括两个区段704和704′,此两区段在俯视图中呈圆形并通过鳍片705相互相连。鳍片705的宽度B小于圆形区段704、704′的直径D。用于放置埋头螺钉的两个穿过板的膛孔706、706′设置成与圆形区段共轴。如图35b
所示,板的第一面707有一个凸起的弯曲而板的第二面708有凹陷的弯曲,该凹陷的弯曲是用于使这面紧靠骨头。板701的两个面707、708的不同曲率半径导致板701朝侧边709方向逐渐变薄。这使板既稳定又节省空间。如图35b中所示,膛孔706、706′各包括孔706a、锥形第一区段706b和第二区段706c;其中孔706a邻近板的第二面708,锥形第一区段706b邻近该孔,第二区段706c邻近第一区段和板的第一面707。它们的形状使得膛孔706和706′适合接受埋头螺钉。膛孔706和706′的形状可以和上面描述的不同,只要它们适合接受埋头螺钉即可。
As yet another application example of the
图36所示的是图35a中的连接部件的一个应用实例。其中板701通过两颗骨螺钉710从后侧固定于位于颈段脊柱的两个椎骨711,通过弹性部件601连到该板701的杆形部件631通过三个骨锚固螺钉部件715锚定于胸段脊柱的椎骨712上。
Figure 36 shows an application example of the connection part in Figure 35a. Wherein the
图37a所示的是本发明中的弹簧部件601用在动态骨盆稳固装置730中的再一个应用实例。该动态骨盆稳固装置包括通过杆形部件631、631′和631″和弹簧部件601和601″相互连接的骨锚固部件728、728′和728″。
Fig. 37a shows another application example in which the
和其他两个骨锚固部件728′和728″一样,骨锚固部件728包括两个半部725和731,这两个半部是通过一个螺钉727相互连接起来的,螺钉727与第一半部725中的螺纹734和第二半部731中的螺纹735啮合。在图37a中的俯视图只显示上面的半部725。杆形部件631夹在前面所提到的两个半部725、731之间,并在第一半部725上的凹陷732内和在第二半部731上的凹陷733内,这样就将骨锚固部件728牢固地连接到杆形部件631上。此外,两个半部725、731分别有膛孔736、737,在装配的状态下这两个膛孔同轴排列。膛孔736附近的球形凹陷738和膛孔737附近的球形凹陷739用于容纳骨螺钉726。骨螺钉726包括一个杆形区段751和一个球台状的螺帽区段753,其中杆型区段751上带有用于旋入骨头的外螺纹752,球台状螺帽753的半径与球形凹陷738和739的半径基本相等。
Like the other two bone anchoring parts 728' and 728", the bone anchoring part 728 includes two halves 725 and 731, which are connected to each other by a screw 727, the screw 727 is connected to the first half 725 The thread 734 in and the thread 735 engagement in the second half 731. The top view in Fig. 37a shows only the upper half 725. The rod-shaped
与骨锚固部件类似,连接部件724也有两个半部722,在图37a的俯视图中只能看到一个。通过进入凹陷,杆形部件631夹在前面所述的两个半部722中,从而使连接部件724牢固相接到杆形部件631上。
Similar to the bone anchoring member, the connecting member 724 also has two halves 722, only one of which is visible in the top view of FIG. 37a. By entering the recess, the rod-shaped
杆部件721包括一个球形头区段721b和一个杆区段721a。头区段721b被未示出的、两个半部722之间的凹陷夹住从而与两个半部722相连使得它被固定于一个枢轴位置。在与头部721b相反的另一末端是杆状部件721a,其包括一个带有外螺纹的圆柱型突出物(图中未示出),其中外螺纹可以旋入弹性部件601′中的内螺纹(图中未示出)。 The stem part 721 includes a spherical head section 721b and a stem section 721a. The head section 721b is clamped by a not shown recess between the two halves 722 so as to be connected to the two halves 722 so that it is fixed in a pivotal position. At the other end opposite the head 721b is a rod member 721a, which includes a cylindrical protrusion (not shown) with an external thread that can be screwed into an internal thread in the elastic member 601' (not shown in the figure). the
弹性部件的制作可用铣工的方法,其所用的原材料是由具有生物相容性的材料如钛构成、具有预定外直径的圆柱体,然后使用薄片铣刀沿一个其主轴与圆柱体的主轴同一直线的螺旋线铣出凹陷。随后,沿圆柱体的主轴形成膛孔,此孔贯穿圆柱体全长,并使螺旋形凹陷终止到膛孔上。为了保证弹性部件的稳定性,螺旋部分和弹性部件端侧区段之间过渡的螺旋尾部是很重要的。因此有必要在螺旋的两端部使用立铣刀修整螺旋尾部,以除去膛孔内部的锐利的边缘。为了达到这个目的,螺旋尾部使用立铣刀沿螺旋轮廓的切线方向进行铣削。随后,将整个组件的内外侧毛刺清除。最后,在膛孔的两个端部区段分别制作出内螺纹。 The elastic part can be produced by the method of milling. The raw material used is a cylinder made of a biocompatible material such as titanium with a predetermined outer diameter, and then a sheet milling cutter is used along a line whose main axis is the same as the main axis of the cylinder. The helical line mills out the depression. Subsequently, a bore is formed along the major axis of the cylinder, which runs the full length of the cylinder and terminates the helical depression in the bore. In order to ensure the stability of the elastic element, the helix end of the transition between the helical part and the end section of the elastic element is important. It is therefore necessary to trim the helix tail with an end mill at both ends of the helix to remove the sharp edges inside the bore. To achieve this, the helix tail is milled tangentially to the helix profile using an end mill. Subsequently, the entire assembly is deburred inside and outside. Finally, an internal thread is produced in each of the two end sections of the bore. the
除了可以使用铣削技术外,弹性部件800也可使用线切割放电加工、激光处理或水刀处理由圆柱体加工而成。如图38所示,加工也可以从一个有预定外直径D′的圆柱体开始,在随后的步骤中沿圆柱体的主轴线A形成一个贯穿圆柱体全长的膛孔801。随后依据壁的厚度选择上述的一种加工方法,沿螺旋802切割依此制成的中空圆柱体壁。螺旋802的尾部803形成为一个1/4圆的形状,从而使相对于铣削工序中通过额外的工序来完成尾部803变得不必要。而且,这些工序中也无需清理毛刺。尾部的形状也不必一定是1/4圆,可以是任何其他形状比如圆的另一区段的形状,只要通过这些形状使材料在使用
过程中的最大负载能保持在低的水平即可。
In addition to milling techniques,
最后,如采用铣工的制作工艺一样,在膛孔两端区段各自形成内螺纹。 Finally, as with the milling process, an internal thread is formed in each end section of the bore. the
在一种改进形式中,上述方法可修改成以在工序开始时在车床上车出带有外螺纹的圆柱形突出物来取代至少一个内螺纹。在这个情况中,膛孔的直径必须小于圆柱形突出物的直径。 In a refinement, the method described above can be modified to replace at least one internal thread by turning a cylindrical protrusion with an external thread on a lathe at the beginning of the process. In this case, the diameter of the bore must be smaller than the diameter of the cylindrical protrusion. the
在又一种的改进制作工序中,弹簧部件制作成没有连续的膛孔。 In yet another modified fabrication process, the spring member is fabricated without a continuous bore. the
Claims (29)
Applications Claiming Priority (11)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US51211303P | 2003-10-17 | 2003-10-17 | |
| DE10348329.2 | 2003-10-17 | ||
| US60/512,113 | 2003-10-17 | ||
| DE10348329A DE10348329B3 (en) | 2003-10-17 | 2003-10-17 | Rod-shaped element used in spinal column and accident surgery for connecting two bone-anchoring elements comprises a rigid section and an elastic section that are made in one piece |
| US52394603P | 2003-11-21 | 2003-11-21 | |
| US60/523,946 | 2003-11-21 | ||
| US55018204P | 2004-03-03 | 2004-03-03 | |
| US60/550,182 | 2004-03-03 | ||
| DE102004021861.7 | 2004-05-04 | ||
| DE102004021861A DE102004021861A1 (en) | 2004-05-04 | 2004-05-04 | Implant for temporary or permanent replacement of vertebra or intervertebral disk, comprising solid central element and outer elements with openings |
| PCT/EP2004/011782 WO2005039454A2 (en) | 2003-10-17 | 2004-10-18 | Flexible implant |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910163700.1A Division CN101647734B (en) | 2003-10-17 | 2004-10-18 | Flexible implant |
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| Publication Number | Publication Date |
|---|---|
| CN1870952A CN1870952A (en) | 2006-11-29 |
| CN1870952B true CN1870952B (en) | 2012-07-18 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN200910163700.1A Expired - Fee Related CN101647734B (en) | 2003-10-17 | 2004-10-18 | Flexible implant |
| CN2004800305254A Expired - Fee Related CN1870952B (en) | 2003-10-17 | 2004-10-18 | elastic implant |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910163700.1A Expired - Fee Related CN101647734B (en) | 2003-10-17 | 2004-10-18 | Flexible implant |
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Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100837108B1 (en) * | 2008-01-11 | 2008-06-11 | 최길운 | Flexible Rod for Spinal Fixation |
| KR20130097206A (en) * | 2010-09-20 | 2013-09-02 | 신세스 게엠바하 | Compliant implant |
| CN106236226B (en) * | 2014-10-24 | 2019-08-09 | 中南大学湘雅三医院 | A coil-spring external fixator adaptable to comminuted fractures |
| CN105078623B (en) * | 2015-09-02 | 2017-03-22 | 李志忠 | Biological self-locking artificial intervertebral disk system and application thereof |
| CN108236518A (en) * | 2016-12-23 | 2018-07-03 | 重庆润泽医药有限公司 | Operation tantalum bar device |
| CN106943215A (en) * | 2017-04-25 | 2017-07-14 | 中国人民解放军第二军医大学第二附属医院 | A kind of adjustable assembly type artificial vertebral body |
| CN109481090A (en) * | 2017-09-13 | 2019-03-19 | 重庆润泽医药有限公司 | Porous tantalum tantalum stick |
| CN107961065B (en) * | 2018-01-09 | 2020-09-11 | 绍兴市人民医院 | Orthopedic implant |
| CN113413255B (en) * | 2021-08-24 | 2021-11-16 | 南通欣昌减震器有限公司 | Blood vessel supporting rubber stent |
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|---|---|---|---|---|
| FR2634371A1 (en) * | 1988-07-21 | 1990-01-26 | Flegeau Gerard | Hip prosthesis and method for manufacturing such a prosthesis |
| US5423817A (en) * | 1993-07-29 | 1995-06-13 | Lin; Chih-I | Intervertebral fusing device |
| US5423816A (en) * | 1993-07-29 | 1995-06-13 | Lin; Chih I. | Intervertebral locking device |
| FR2717370A1 (en) * | 1994-03-18 | 1995-09-22 | Moreau Patrice | Intervertebral stabilising prosthesis for spinal reinforcement inserted during spinal surgery |
| EP0950389A2 (en) * | 1998-04-16 | 1999-10-20 | Aesculap AG & Co. KG | Intervertebral fusion implant |
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- 2004-10-18 CN CN200910163700.1A patent/CN101647734B/en not_active Expired - Fee Related
- 2004-10-18 CN CN2004800305254A patent/CN1870952B/en not_active Expired - Fee Related
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2634371A1 (en) * | 1988-07-21 | 1990-01-26 | Flegeau Gerard | Hip prosthesis and method for manufacturing such a prosthesis |
| US5423817A (en) * | 1993-07-29 | 1995-06-13 | Lin; Chih-I | Intervertebral fusing device |
| US5423816A (en) * | 1993-07-29 | 1995-06-13 | Lin; Chih I. | Intervertebral locking device |
| FR2717370A1 (en) * | 1994-03-18 | 1995-09-22 | Moreau Patrice | Intervertebral stabilising prosthesis for spinal reinforcement inserted during spinal surgery |
| EP0950389A2 (en) * | 1998-04-16 | 1999-10-20 | Aesculap AG & Co. KG | Intervertebral fusion implant |
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| CN101647734A (en) | 2010-02-17 |
| CN1870952A (en) | 2006-11-29 |
| CN101647734B (en) | 2014-05-07 |
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