CN101636117A - 棘突间植入物 - Google Patents

棘突间植入物 Download PDF

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CN101636117A
CN101636117A CN200780049212A CN200780049212A CN101636117A CN 101636117 A CN101636117 A CN 101636117A CN 200780049212 A CN200780049212 A CN 200780049212A CN 200780049212 A CN200780049212 A CN 200780049212A CN 101636117 A CN101636117 A CN 101636117A
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implant
side member
spinous process
central module
arm
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CN101636117B (zh
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吉恩·泰勒
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7065Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor

Abstract

本植入物(1)能配合在两个椎骨的棘突之间并由可弹性变形的材料块体(10,11)制成根据本发明,所述块体被分成由第一可弹性变形材料制成的中心部件(10)以及由比所述第一材料更刚性的第二可弹性变形的材料制成的两个侧向部件(11),所述侧向部件(11)位于中心部件(10)的相对两侧向侧上,也就是说,在设计成在植入之后纵向位于棘突的每一侧上的那些侧上,并且所述侧向部件(11)连接于所述中心部件(10)。

Description

棘突间植入物
技术领域
本发明涉及一种棘突间植入物。
背景技术
通过以申请人名义提出的文献WO 99/42051可以获知如何生产可弹性变形的棘突间植入物,该可弹性变形的棘突间植入物能阻尼脊柱牵伸过程中椎骨的向后运动。该植入物基本上呈H形,也就是说,它包括一对凸伸的上臂和一对凸伸的下臂,上下臂分别界定能接受两椎骨的棘突的上下凹部;它由特别是硅酮的可变形粘弹性材料块体制成,并可能被包含在特别是聚酯的织物材料的包覆物中。
该植入物在实践中很令人满意,它构成对椎骨外科治疗的其它方法,特别是用椎弓根螺钉和连接杆装配刚性材料以连结所治疗的椎骨的椎弓根骨接合术方法的一种侵入性更小的替代方式。
然而,在某些情况下,特别是在患者病情严重或患者有局部补偿性脊柱前凸过度的情况下,现有植入物的阻尼能力是不足的。在这样的患者体内装配可用植入物范围内现有的最大植入物并非是令人满意的解决方案,这是因为,会有在椎间盘上产生特别是向前的过大牵引并导致过大压力的危险。
此外,看起来似乎不能总是理想地保证将植入物保持在位,特别是在脊柱纵向扭转运动或其侧向弯曲运动的过程中。借助于穿过植入物的棘突间中间部件并围绕棘突配合的韧带(ligament)可部分地减小这样的危险,但这使得植入物的装配侵入性更大。
文献WO 2006/106246描述了一种植入物,它包括两个不同的刚性件以及用于将这些刚性件呈相互旋转关联而形成旋转体的装置。在植入件上存在这样的刚性件并非是人们希望的,这是因为在植入物磨损和/或运动的情况下可能存在危险。该植入物并不受到出现在由可变形材料块体构成的植入物上的前述技术问题,即在某些情况下阻尼能力不足的问题和无法理想地保证保持在位的问题的影响。
文献US 2005/203512描述了一种棘突间植入物,该植入物包括由高分子量的聚乙烯或PEEK(即刚性材料)制成的棘突间中心部件以及由形状记忆金属制成的凸伸臂。特别是,位于同一侧的凸伸臂由形状记忆金属制成的同一刃片形成,该刃片穿过植入物的棘突间部分。
对根据该现有技术文献的植入物可作出如上所述的相同评论。
发明内容
本发明旨在补救由可变形材料块体制成的植入物所引起的上述问题。
如本身已知的,所关注的植入物适于配合在两个椎骨的棘突之间并由可弹性变形材料块体制成。
根据本发明,所述块体被分成由第一可弹性变形材料制成的中心部件和由比所述第一材料更刚性的第二可弹性变形的材料制成的两个侧向部件,所述侧向部件位于中心部件的相对两侧向侧上,也就是说,在设计成在植入之后纵向位于棘突的每一侧上的那些侧上,并且所述侧向部件连接于所述中心部件。
实际上,本发明人发现,在某些临床的解剖学情况下现有植入物的阻尼能力不足是由于在所述压缩力的作用下植入物材料的侧向蠕变造成的。在根据本发明的植入物中,由更刚性的材料制成的所述侧向部件可抵制构成块体的所述中心部件的材料发生侧向蠕变的危险。
较佳的是,由更刚性的材料制成的侧向部件由连接部件穿过植入物的棘突间中间部分来彼此连接。
除了由更刚性的材料制成的所述侧向部件的固有刚度之外,该连接部件还可理想地抵抗前述的植入物的所述中心部件的侧向蠕变。
所述连接部件较佳的是由与更刚性材料制成的两个侧向部件相同的材料制成。
所述连接部件可以是管状的,以在需要时供一根或多根韧带穿过植入物,这些韧带相对于椎骨提供对植入物的附加保持作用。连接部件的横截面也可以是实心的,于是增加植入物的棘突间部件的阻尼程度。
植入物可具有平行六面体或圆柱形状,在这种情况下,通过穿过植入物的中间部分来连接由更刚性的材料制成的所述侧向部件,就可获得对植入物中心部件的侧向蠕变的抵抗能力。然而,较佳的是,根据本发明的植入物具有H形,也就是说,它包括一对上凸伸臂和一对下凸伸臂,各对凸伸臂分别界定能接纳两个椎骨的棘突的上下凹部,并且,由更刚性的材料制成的所述侧向部件在所述凸伸分支中的至少一个分支的高度的至少一部分上延伸。
由更刚性的材料制成的所述侧向部件在该情况下具有以下优点:加强所述凸伸臂中的一个或多个的刚度,并因而增加稳定性并提高植入物在装配后的在位保持度,尤其是在脊柱扭转运动或脊柱侧向弯曲的情况下。本发明人发现,前述的根据现有技术的植入物发生移动的危险是由于特别是在植入物材料的发生明显的侧向蠕变的情况下的该植入物的凸伸臂刚度不足造成的。根据本发明的由更刚性的材料制成的所述侧向部件使这个问题得以解决。
这些由更刚性的材料制成的侧向部件较佳地在所述凸伸臂的整个高度上延伸。于是,构成这些侧向部件的所述第二材料的刚度就足以确保在构成所述块体的材料蠕变方面对植入物的中心部件进行前述的侧向约束。这些侧向部件还可以由连接部件穿过植入物的棘突间中间部分来彼此连接。
由更刚性的材料制成的所述侧向部件较佳的是在每个侧向部件与中心部件的整个组装界面上紧密地结合于形成植入物中心部件的可弹性变形材料。若可防止一个组装面相对于另一组装面的滑动,则在整个该界面上的连接就有助于抵抗中心部件的材料侧向蠕变。
在这种情况下,植入物可通过以下方式获得:将由更刚性的材料制成的所述侧向部件模制在所述中心部件上;或者,当由更刚性的材料制成的侧向部件在棘突间中间部件处彼此连接时,将所述中心部件模制在由更刚性的材料制成的所述侧向部件上和形成所述连接的部件上。
当植入物具有H形时,由更刚性的材料制成的所述侧向部件中的至少一个在植入物的棘突间中间部分处厚度减小,从而允许相应的上下凸伸臂朝向彼此弯曲,以使植入物可侧向插入棘突间空隙。
若侧向插入可比后部插入更好地保持韧带系统的完整性,则这样的侧向插入可能性是有利的。
所述第一材料尤其可以是粘弹性材料。该材料具有可变的刚度,该刚度随着该材料承受的压缩程度的增加而增大。
所述第一材料特别可以是硅酮,硬度例如为65肖氏A。
所述第二材料具有比第一材料高的硬度。例如它可以是硬度约为85肖氏A的硅酮。
植入物可以被包含在由特别是聚酯的织物材料制成的护套中。
附图说明
参照以非限制性例子的方式示出本发明所涉及植入物的若干可能实施例的示意性附图,可更清楚地理解本发明,且本发明的其它特征和优点也会显现出来。
图1是根据第一实施例的植入物沿着图2中的线I-I的剖视图;
图2是植入物沿着图1中的线II-II的剖视图;
图3是根据第二实施例的与图1相似的植入物视图;
图4是根据该第二实施例的植入物在植入构造下的视图;
图5是根据第三实施例的与图1相似的植入物视图;
图6是根据第四实施例的与图1相似的植入物视图。
为了简化,一个实施例中的部分或元件若在另一实施例中以相同或相似的方式再次出现,则用相同的附图标记来标示它并将不再对它进行描述。
具体实施方式
图1和2示出一棘突间植入物1,它适于插入在两个椎骨的棘突之间,以能阻尼这些椎骨在脊柱牵伸过程中的向后运动。植入物1基本上呈H形,也就是说,它包括用于放置在所述棘突之间的中间部件2、界定上凹部4的一对凸伸上臂3以及界定下凹部6的一对凸伸下臂5,这些凹部4和6能接纳两个椎骨的棘突。
如图2所示,臂3和5具有截头的前部上边缘3a和5a,这些上边缘分别倾斜并呈圆角形,以使植入物1可装配在椎骨的棘突的基部处,并尽可能靠近板层。
植入物1还包括形成为穿过部件2的管道7,该管道7的端部是外张的。如果需要,该管道7可用来装配穿过其并围绕两椎骨的棘突配合的韧带。
植入物1可包括由特别是聚酯的织物材料制成的包覆物,该包膜将其完全包覆住。
如图所示,植入物1由不同材料制成的部件形成,即:
-中心部件10,其由第一可弹性变形材料,例如硬度为65肖氏A的硅酮制成的;以及
-两个侧向部件11,其由比所述第一材料更刚性的第二可弹性变形的材料制成,位于中心部件10的相对两侧向侧,也就是说在设计成在植入后纵向位于棘突的每一侧上的那两侧上,这些侧向部件11连接至中心部件10。
侧向部件11在植入物1的整个高度上延伸;在图1所示的实施例中,它们的厚度除了在臂3和5的自由端部处变化稍大之外几乎不变化,并且它们在与中心部件10的整个组装界面上与该中心部件紧密结合。它们特别可由肖氏A硬度比中心部件10的材料高的硅酮制成,例如约85肖氏A的材料,并且它们被模制到该中心部件10上。
这些更刚性的侧向部件11可抵制构成中心部件10的材料在可能由棘突施加在部件2上的高压缩力的作用下发生侧向蠕变的危险,因此为该部件2保存足够的阻尼能力。
侧向部件11还具有加强臂3和5的刚度并因而提高植入物1在装配后的在位保持度的效果,特别是在脊柱扭转运动或其侧向弯曲的情况下,以及尤其是在部件2受到明显压缩的情况下。
图3示出侧向部件11可在植入物1的棘突间中间部分处具有减小的厚度,从而如图4所示,允许位于植入物1同一侧上的臂3和5朝向彼此弯曲,以使得植入物可插入棘突间的空隙。臂3和5可借助于保持连结件15保持在该弯曲的位置。
图5示出侧向部件11也可通过植入物1的部件2来彼此连接。该部件2于是包括由两个部件11和中间连接部件12构成的元件,中心部件10覆盖模制在该元件上。
在这种情况下,连接部件12是管状的,以在需要时允许一根或多根韧带穿过其以相对于椎骨提供对植入物1的附加保持作用。图6示出连接部件12也的横截面也可以是实心的,于是可提高植入物1的棘突间部件的阻尼程度。
如从上文中清楚地可见,本发明提供一种棘突间植入物,它由可弹性变形材料块体制成,在任何情况下都具有足够的阻尼能力,尤其是在特别严重的患者或有局部代偿性脊柱前凸过度的那些患者的情况下也具有足够的阻尼能力,并且加强植入物保持在位的作用,这样就可不再需要围绕所治疗的椎骨棘突装配韧带。
无需说,本发明并不局限于以上以举例方式描述的实施例,而可延伸到所附权利要求书所涵盖的所有实施例。

Claims (11)

1.棘突间植入物(1),所述棘突间植入物能配合在两个椎骨的棘突之间,并由可弹性变形材料块体(10,11)制成,其特征在于,所述块体被分成由第一可弹性变形材料制成的中心部件(10)以及由比所述第一材料更刚性的第二可弹性变形的材料制成的两个侧向部件(11),所述侧向部件(11)位于所述中心部件(10)的相对两侧向侧上,也就是说,在设计成在植入之后纵向位于所述棘突的每一侧上的那些侧上,并且所述侧向部件(11)连接于所述中心部件(10)。
2.如权利要求1所述的植入物,其特征在于,由更刚性的材料制成的所述两个侧向部件(11)由连接部件(12)穿过所述植入物(1)的棘突间中间部分彼此连接。
3.如权利要求2所述的植入物,其特征在于,所述连接部件(12)由与更刚性材料制成的所述两个侧向部件(11)相同的材料制成。
4.如权利要求2或3所述的植入物,其特征在于,所述连接部件(12)的横截面是实心的。
5.如权利要求1至4中任一项所述植入物,其特征在于,所述植入物呈H形,也就是说,包括一对上凸伸臂(3)和一对下凸伸臂(5),各对凸伸臂分别界定能接纳两个椎骨的棘突的上下凹部(4,6),并且,由更刚性的材料制成的所述侧向部件(11)在所述凸伸臂(3,5)中的至少一个臂的高度的至少一部分上延伸。
6.如权利要求5所述的植入物,其特征在于,由更刚性的材料制成的所述侧向部件在所述凸伸臂(3,5)的整个高度上延伸。
7.如权利要求6所述的植入物(1),其特征在于,由更刚性的材料制成的所述侧向部件(11)由连接部件(12)穿过所述植入物(1)的棘突间中间部分彼此连接。
8.如权利要求1至7中一项所述的植入物(1),其特征在于,由更刚性的材料制成的所述侧向部件(11)在每个所述侧向部件(11)与所述中心部件(10)的整个组装界面上紧密地结合于所述中心部件(10)。
9.如权利要求5至8中一项所述的植入物,其特征在于,所述侧向部件(11)中的至少一个具有在所述植入物(1)的棘突间中间部分处厚度减小的部分(11a),从而允许相应的所述上下凸伸臂(3,5)朝向彼此弯曲,以使所述植入物(1)可侧向插入棘突间空隙。
10.如权利要求1至9所述的植入物(1),其特征在于,所述中心部分(10)和所述侧向部分(11)由硅酮制成。
11.如权利要求1至10中一项所述的植入物(1),其特征在于,所述中心部分(10)和所述侧向部分(11)被包含在特别是聚酯的织物材料的护套中。
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CN102596069B (zh) * 2009-11-06 2015-01-28 新特斯有限责任公司 最小限度侵入棘突间分隔植入物和方法

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EP2088949B1 (en) 2015-06-17
WO2008056237A2 (en) 2008-05-15
FR2908035A1 (fr) 2008-05-09
FR2908035B1 (fr) 2009-05-01
WO2008056237A3 (en) 2008-09-04
US20100070038A1 (en) 2010-03-18
JP5583804B2 (ja) 2014-09-03
JP2013135925A (ja) 2013-07-11
CN101636117B (zh) 2011-12-28
EP2088949A2 (en) 2009-08-19
KR20090108589A (ko) 2009-10-15
JP2010508934A (ja) 2010-03-25
IL198649A0 (en) 2010-02-17
AU2007318980A1 (en) 2008-05-15
US8118839B2 (en) 2012-02-21

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