CN101227867A - 具有可展开翼状物的椎突间植入体及其植入方法 - Google Patents

具有可展开翼状物的椎突间植入体及其植入方法 Download PDF

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CN101227867A
CN101227867A CNA2006800219332A CN200680021933A CN101227867A CN 101227867 A CN101227867 A CN 101227867A CN A2006800219332 A CNA2006800219332 A CN A2006800219332A CN 200680021933 A CN200680021933 A CN 200680021933A CN 101227867 A CN101227867 A CN 101227867A
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implant
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CN101227867B (zh
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詹姆斯·F·朱彻曼
肯·Y·许
亨利·A·克利斯
查尔斯·J·温斯洛
斯科特·A·耶比
约翰·J·弗林
史蒂文·T·米切尔
约翰·A·马克沃特
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Medtronic PLC
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Kyphon Inc
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    • 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
    • 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
    • A61B17/7068Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
    • 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
    • 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
    • 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

Abstract

根据本发明的系统的实施例可包括一具有间隔器和翼状物的植入体,该间隔器具有一定厚度,其中所述翼状物的第一构型具有实质上类似于厚度的第一高度,并且其中所述翼状物适于可选择地设置在第二构型中,使得所述翼状物具有大于第一高度的第二高度。所述植入体的外表面具有基本上与套管的内表面形状一致的形状和小于所述套管内径的截面直径。所述套管被插入以使得套管的近端设置在相邻椎突之间。所述植入体然后通过套管被推进相邻椎突之间的位置,随后被设置在第二构型中以将植入体固定就位。

Description

具有可展开翼状物的椎突间植入体及其植入方法
优先权声明
美国临时申请,申请号:No.60/672,402,名称:INTERSPINOUSPROCESS IMPLANT HAVING DEPLOYABLE WINGS AND METHOD OFIMPLANTATION(具有可展开翼状物的椎突间植入体及其植入方法),申请人:James F.Zucherman等,提交日:2005年4月18日(代理人档案号:No.KLYC-01096US0);和
美国专利申请,申请号:No.11/389,002,名称:INTERSPINOUSPROCESS IMPLANT HAVING DEPLOYABLE WINGS AND METHOD OFIMPLANTATION(具有可展开翼状物的椎突间植入体及其植入方法),申请人:James F.Zucherman等,提交日:2006年3月24日(代理人档案号:No.KLYC-01096US1)。
技术领域
本发明涉及椎突间植入体。
背景技术
脊椎柱是生物机械结构,主要包括韧带、肌肉、椎骨和椎间盘。脊椎的生物机械功能包括:(1)支撑身体,其包括传递头部、躯干和手臂的重量以及弯曲运动到骨盆和腿部;(2)综合这些部位之间的生理运动;和(3)保护脊髓和神经根。
随着现代社会的老龄化,可预见的是以老年人为代表的脊椎健康恶化将会增加。仅通过例子即可说明,随着年龄的增长,带来脊椎的狭窄(包括,但不限于,中央管和横向的狭窄)和小面关节病增加。脊椎狭窄导致小孔面积的减小(也就是神经和血管的通路的可使用空间变小),其压迫颈部神经根并导致根疼痛。参见Humpreys,S.C.等人在Arch.Phys.Med.Rehabil(1998年9月,第79卷第1105页)上发表的文章Flexion and traction effect on C5-C6foraminal space。脊椎狭窄的另一症状是脊髓病,其导致颈部疼痛和肌肉无力。颈部的伸长和同侧扭转进一步减少小孔面积并导致疼痛、神经根压迫和神经损伤。参见Yoo,J.U.等人在Spine(1992年11月10日,第17卷第1131页)上发表的文章Effect of cervical spine motion on the neuroforaminaldimensions of human cervical spine。相反,颈部的弯曲增加小孔面积,如Humpreys S.C.等人在第1105页指出。狭窄引起的疼痛可通过药物和/或手术而减轻。期望消除对于所有人群的大的手术的需要,尤其是对于老年人。
相应地,需要开发一种可减缓脊椎狭窄所致的疼痛以及其它颈椎损伤或变性所致的此类病况的脊椎植入体。这种植入体将分离椎骨或增加椎骨间的距离以增加小孔面积,从而降低颈椎的神经和血管的压力。
另外一种需求是开发出一种最小侵入手术植入颈椎植入体的方法,其可保护颈椎生理。
此外,需要一种植入体,其可适应脊椎的独特解剖结构,最小化对脊椎的进一步损伤,并消除对于手术植入的侵入方法的需要。此外,需要解决脊椎伸长引起的不利脊椎状况。
发明内容
附图说明
借助附图解释本发明的实施例的其它细节,其中:
图1是根据本发明的植入体的实施例的透视图,其具有间隔器、分离导引器和具有椭圆截面的翼状物。
图2是图1所示植入体的端视图。
图3是另一根据本发明的植入体的实施例的透视图,其具有泪珠形截面的翼状物。
图4是与图3所示的植入体一起使用的第二翼状物的端视图。
图5是根据本发明的植入体的实施例的透视图,其具有可旋转间隔器和具有椭圆形截面的翼状物。
图6是根据本发明的植入体的实施例的透视图,其具有带有两个泪珠形截面的翼状物的可旋转间隔器。
图7示出从末端进行观察的图6所示的植入体的旋转轴。
图8是根据本发明的植入体的实施例的透视图,其具有从后端截短的翼状物。
图9A是图8所示的植入体的端视图。
图9B是与图9A所示的植入体一起使用的截短的第二翼状物。
图10是根据本发明的植入体的实施例的平面图,其中一螺钉用于固定第二翼状物至间隔器。
图11是图10所示的第二翼状物的透视图。
图12是图10所示的植入体的透视图。
图13A是与本发明的植入体的一些实施例一起使用的第二翼状物的主视图,其具有用于固定第二翼状物到植入体的活动铰链机构。
图13B是图13A所示的第二翼状物的侧截面视图。
图14A是与图13A和13B所示的第二翼状物一起使用的植入体的实施例的平面图。
图14B是13A和13B所示的第二翼状物的主视图。
图15A是定位在相邻颈椎的椎突之间的根据本发明的植入体的实施例的俯视图。
图15B是图15A所示的植入体的俯视图,其示出了翼状物的定向。
图16是图15A和15B所示的本发明的这两个植入体的俯视图,其定位在颈椎中。
图17是本发明的定位在颈椎中的两个植入体的侧视图,其具有在椎突的近端的止动器或保持器。
图18A是根据本发明的植入体的替换实施例的透视图,其具有第一翼状物和第二翼状物,该第一翼状物和第二翼状物在将植入体设置在相邻椎突之间后可以展开。
图18B是处于展开构型的图18B所示的植入体透视图。
图19A是定位在相邻椎突之间处于非展开构型的图18A和18B所示的植入体的后视图。
图19B是定位在相邻椎突之间处于展开构型的图18A和18B所示的植入体的后视图。
图20A是另一根据本发明的植入体的实施例的透视图,其具有第一翼状物和第二翼状物,该第一翼状物和第二翼状物在将植入体设置在相邻椎突之间后可以展开。
图20B是处于展开构型的图20A所示的植入体的透视图。
图21是定位在相邻椎突之间处于展开构型的图20A和20B所示的植入体的后视图。
图22A是根据本发明的植入体的替换实施例的透视图,其具有第一翼状物和第二翼状物,该第一翼状物和第二翼状物在将植入体设置在相邻椎突之间后可以展开。
图22B是处于部分展开构型的图22A所示的植入体的透视图。
图22C是处于完全展开构型的图22A所示的植入体的透视图。
图23A是图22A所示的植入体的透视图,其包括一套管,该植入体被布置在套管里以插入相邻椎突之间的期望位置。
图23B是处于部分展开构型的图23A所示的植入体的透视图。
图23C是示出由绳索连接的铰链结构的图23A所示的植入体的放大透视图。
图24示出植入根据本发明的图1-17所示的椎间植入体的方法的实施例。
图25示出植入根据本发明的具有可展开的第一和第二翼状物的图18A-21所示的椎间植入体的方法的实施例。
图26示出通过插入在相邻椎突之间的套管植入根据本发明的图22A-23B所示的具有可展开的第一和第二翼状物的椎间植入体的方法的替换实施例。
具体实施方式
图1和图2示出根据本发明的实施例的植入体100。植入体100包括翼状物130、间隔器120和引入组织扩张器(在此及后也称作分离导引器)分离导引器110。在该特定实施例中,分离导引器110为楔形,也就是,植入体具有从植入体的远端102到区域104的逐渐扩大的截面,在区域104处导引器110与间隔器120结合(图中参考是基于椎突之间的植入体的插入点)。这样,当植入体100手术中插入椎突之间时,分离导引器起到使得软组织和椎突分开的功能。可理解的是,为了便于将植入体100插入相邻的颈椎的椎突之间,可将分离导引器110弄尖等。这样做是有利的,为了减少对手术部位的创伤并促进早日愈合,插入技术尽可能地只影响到一点骨头和周围组织或韧带,防止正常解剖的不稳定。在图1和图2的实施例中,不需要移去任何椎突的骨头,并且不需要从人体切断或移去与椎突直接相连的韧带和组织。例如,不必切断项韧带(棘上韧带),其部分地衬垫上颈椎的椎突。
从图1-3可看出,间隔器120的垂直于植入体100的纵向轴125的截面可为泪珠形状。以这种方式,间隔器120的形状可大致与相邻椎突之间的楔形空间或楔形空间的一部分相一致,其中植入体100定位在所述椎突中。在其它实施例中,间隔器120可具有替换形状例如圆形、楔形、椭圆形、卵形、足球形和具有圆边角的矩形和其它形状,其在本发明的精神和范围之中。间隔器120的形状可针对特定患者选定,使得医生可尽可能接近椎突表面的前部地定位植入体100。为间隔器120所选的形状可影响植入体100和待经受分离的椎突的接触表面积。增加植入体100和椎突之间的接触表面积可分散椎架和植入体100之间的力和负载。
从图1和图2可看出,在一实施例中的翼状物130的垂直于纵向轴125的截面可为椭圆形状的。翼状物130的尺寸可比间隔器120的尺寸大,尤其是沿着中心轴,并可限制或阻挡植入体100在沿着纵向轴125的插入方向的侧向位移。如图3的实施例所示,翼状物130还可替换地具有其它截面形状,例如泪珠形、楔形、圆形、卵形、足球形和圆边角的矩形以及其它形状,其都在本发明的精神和范围之内。翼状物130具有前部138和后部136。
在其它实施例中,植入体100可包括两个翼状物,其第二翼状物160(如图4所示)与分离导引器110、间隔器120和第一翼状物130分开。第二翼状物160可连接至间隔器120的远端。第二翼状物160,类似于第一翼状物130,可限制或阻挡植入体100的侧向位移,但是沿着纵向轴125的反向插入方向的位移也被限制或阻挡。当第一翼状物130和第二翼状物160都与植入体100相连并且植入体100定位在相邻椎突之间时,部分椎突可被夹在第一翼状物130和第二翼状物160之间,从而限制沿着纵向轴125的任何位移。
从图4可看出,第二翼状物160的截面可为泪珠形状的。第二翼状物160的宽端166是后端,第二翼状物160的窄端168是前端。然而,与第一翼状物130不同,开口164限定在第二翼状物160中,开口164至少部分地由唇状物162限定,从而允许第二翼状物160通过分离导引器110接触并连接间隔器120。一旦第二翼状物160得以适当地定位,第二翼状物160可固定至间隔器120。在植入体100被定位在椎突之间之后,第二翼状物160可与植入体相连。
可理解的是,植入体可制造为两块。第一块可包括第一翼状物130、间隔器120和分离导引器110。第二块可包括第二翼状物160。每一块可使用本领域已知的技术(例如机加工、模制和挤压成型)进行制造。每一块,如下面将要更加全面描述,可由与患者身体生物相容的材料制成。植入体可形成为具有多块,并且各块适当地接合在一起,或者,植入体可形成为一个整体或者结合在一起成为一个整体。
图5-7示出根据本发明的植入体的其它实施例。在这些实施例中,间隔器220可绕纵向轴225相对于第一翼状物130或者在使用两个翼状物时相对于第一翼状物130和第二翼状物160而旋转。间隔器220相对于分离导引器110可为可旋转的或固定的。在间隔器220相对于分离导引器110是可旋转的场合,间隔器220可包括孔222和轴224,其中孔222长度为纵向轴225的长度,轴224穿过孔222并连接分离导引器110和第一翼状物130。尽可能靠近椎体地定位在此所教导的任何植入体是有利的。当在植入过程中植入体200被插入并定位时,可旋转间隔器220可旋转以适应于或安放在相邻椎突之间,使得平均起来间隔器220和椎突之间的接触表面积可增加超过固定间隔器120和椎突之间的接触表面积。这样,可旋转间隔器220可改善独立于翼状物130、第二翼状物160的间隔器220相对于椎突的定位。图6的实施例包括泪珠形状的第一翼状物130和泪珠形状的第二翼状物160,泪珠形状的第二翼状物160类似于图3的实施例中描述的第二翼状物160。如下所述,图3和图6中的翼状物130、160的形状是这样的以使得植入体100、200适应颈椎沿其轴的扭动,例如,当患者的头部从一侧转向另一侧时。
图8是一透视图,图9A是根据本发明的植入体的另一实施例的端视图,其中泪珠形第一翼状物330的后部336被截去了,使得第一翼状物330在形状上更加卵形。在这种构型中,第一翼状物330的前部138可比第一翼状物330的被截去的后部336长。如前面的实施例,间隔器120也可替换地为一可旋转的间隔器,而非一固定的间隔器。图9B示出用于这种植入体300的第二翼状物360,该第二翼状物360具有截去的后部366。第一和第二翼状物330、60的后部336、366的截去可降低具有这种定位在颈椎的相邻对的椎突之间的第一和第二翼状物330、360的植入体300的干涉的可能性,例如颈椎五和六之间的植入体,颈椎六和七之间的植入体。在颈部的旋转过程中,椎突类似于剪刀运动一样地运动通过彼此。每一颈椎可相对于下一相邻的颈椎在约6°-12°的大致范围内转动。此外,颈部的约50%的旋转运动是通过上面两个颈椎完成的。这样,这种装置可适应颈部的转动,而没有相邻装置之间的彼此干涉。
对于前面的具有第一和第二翼状物130、160的实施例,第二翼状物160可设计为干涉配合到间隔器120上(如果间隔器是固定的)或者与间隔器120相邻的分离导引器110部分上(如果间隔器是可旋转的)。在第二翼状物160是干涉配合的场合,没有额外的附加装置来相对于植入体的其余部分固定第二翼状物160。或者,各种紧固件可用于相对于植入体的其余部分固定第二翼状物。例如,图10-12示出了包括泪珠形第二翼状物460的植入体400的实施例,该第二翼状物460具有穿过第二翼状物460的后端的唇状物461的孔463。当第二翼状物460通过手术插入进入相对于植入体400的其余部分的位置时,孔463对准间隔器120上的相应孔440。螺钉442可在从后部到前部的方向穿过对准的孔463、440以固定第二翼状物460到间隔器120。从后部到前部的插入方向具有螺钉442,螺钉442沿着基本垂直于纵向轴125的方向接合孔463、440和植入体400的其余部分。当需要用手术来使用螺钉442以固定第二翼状物460至植入体400的其余部分时,该方向是最方便的。其它使用插入间隔器120上的相应孔463、440和第二翼状物460的部件的固定机构是在本发明的精神之内。应理解的是,可旋转间隔器220也可通过这种装置调节。使用可旋转间隔器220,第二翼状物460可固定至位于与可旋转间隔器220相邻的分离导引器110的部分。
图13A-14B示出另一实施例500,其中第二翼状物560通过一包括柔性铰链565的机构固定至间隔器120,突起物561在与由部分第二翼状物560限定的开口564的唇状物562相邻的铰链565的末端之上。固定机构也包含在间隔器120上的凹口540,其中凹口540容纳在柔性铰链565末端上的突起物561。在手术过程中,在插入分离导引器110、间隔器120和第一翼状物130之后,第二翼状物560由分离导引器110和间隔器120接收。由于第二翼状物560被间隔器120接收,活动铰链565及其突起物561偏斜直到突起物561接触并与间隔器120中的凹口540结合,从而固定第二翼状物560至间隔器120。再者,在间隔器可旋转的实施例中,凹口540位于与可旋转间隔器220相邻的分离导引器110的末端。对于活动铰链565,该铰链在优选的实施例中与第二翼状物560一起形成,并以这种方式设计,使得其可随着铰链565被推过分离导引器110和间隔器120而弯曲,进而允许突起物561放置到凹口540中。或者,可理解为,凹口540可存在于第二翼状物560中,柔性铰链565和突起物561可存在于间隔器120上,以便将第二翼状物560配合到间隔器120。再或者,柔性铰链565可由柔性突起替换,该柔性突起可弯曲与在间隔器120中具有凹口540的实施例中或在第二翼状物560中具有凹口540的实施例中的凹口540接合。本领域普通技术人员将认识到无数不同的方法,借此第二翼状物可与植入体配合。
图15A-16示出植入体600的实施例,其中第一翼状物630和第二翼状物660的前端从间隔器120向外张开一定角度并彼此分开。颈部椎突自身从上面观察为楔形。第一翼状物630和第二翼状物660向外展开,使得植入体600可大致与椎突的楔形一致,从而允许植入体600定位在尽可能靠近椎骨的椎体,在椎体处椎骨的负载被支撑。第一和第二翼状物630、660相对于间隔器定位,不管间隔器是固定间隔器120还是可旋转间隔器220,因此随着翼状物接近椎骨的椎体时翼状物展开。图15B是图15A的植入体600从接近椎突的地方移去后的俯视图。第一翼状物630相对于垂直于纵向轴(在此也可称为对称平面)的沿椎突的轴一定角度对准。在一实施例中,该角度为约30°,然而,角度θ的范围可为约15°-45°,在其它实施例中,在该范围之外的角度是期望的并是根据本发明的。同样地,第二翼状物660可沿类似地但相反地相对于对称平面的角度变化范围对准。
如上参考图4所述,第二翼状物660限定一唇形轮廓的开口。显然,该唇状物可相对于第二翼状物660的其余部分一定角度设置,使得当唇状物被推入与间隔器120接触时,第二翼状物660具有相对于间隔器120的期望角度。如上所述,存在不同的固定第二翼状物660到间隔器120上的方法。图15A示出一放置在相邻颈椎的椎突之间的这种植入体600的俯视图。图16是示出具有展开的翼状物630、660的双层分离植入体600的俯视图。
根据本发明的系统和方法可包括可以与本发明的植入体结合使用的装置。图17示出一种止动器(在此也可称为“保持器”)656,其是柔性生物相容材料的环状物,该环状物可围绕相邻颈椎的椎突定位并位于植入体600后部。保持器656可防止植入体的后向位移。在一实施例中,保持器可包括具有狭缝658的环状物。保持器656可被弹开一些,使得保持器656可配合在椎突末端上,进而允许一起弹回以为了固定在椎突的一个位置。为了防止植入体600在后向的运动,保持器656可作为间隔器120的挡块。
具有可展开翼状物的植入体
在其它实施例中,根据本发明的植入体可包括具有第一构型(如图18A所示)和第二展开的构型(如图18B所示)的“火柴盒”状的结构。安置在第一构型中,该植入体700可具有厚度大致均匀的基本上平坦的外廓。所述均匀的厚度接近植入体700的间隔器720的厚度。植入体700可包括在植入体近端的分离导引器710,该分离导引器710具有稍稍圆形或锥形的形状以穿过和/或分离相邻椎突之间的间隔。植入体700可还包括多个铰链结构750-757,该铰链结构750-757为折叠起来的以使得有助于基本平坦的外廓。铰链结构750-757是与间隔器720枢轴连接并从间隔器720的两侧延伸。如图18A所示,支撑结构722从间隔器720向着植入体700的远端延伸。杆715(或者一些其它机构,例如凸台)可与植入体700的近端相连并延伸通过铰链结构750-753,通过间隔器720,并通过支撑结构722,使得杆715是可接近的。
参照图18B,一旦植入体700被如期望地定位在相邻椎突之间,杆715可与沿着纵向轴725的插入方向相反的方向拉拽,使得铰链结构750-757向外展开以形成第一翼状物730和第二翼状物760,在第一翼状物730和第二翼状物760之间设置间隔器720和椎突的一部分。由于铰链结构750-757向外展开,第一和第二翼状物730、760的高度从与间隔器720的厚度大致相同的高度增加到一使得当第一和第二翼状物730、760定位在相邻椎突之间时其可限制或阻挡植入体700沿纵向轴725的运动的高度。可看出,第二翼状物760包括四个铰链结构750-753:由铰链连接至上面第二结构752的上面第一结构750,和由铰链连接至下面第二结构753的下面第一结构751。铰链结构750-753向外转动以形成第二翼状物的上端762和第二翼状物的下端764。同样地,第一翼状物730包括四个铰链结构754-757:由铰链连接至上面第二结构756的上面第一结构754,和由铰链连接至下面第二结构757的下面第一结构755。然而,不同于第二翼状物760,第一翼状物730是(有效地)由支撑结构722对截开,使得第一翼状物730包括四个小翼731-734。铰链结构754-757向外转动以形成第一翼状物的上面小翼731、732和第一翼状物的下面小翼733、734。
如上所述,支撑结构722从间隔器720向着植入体700的远端延伸。间隔器720和支撑结构722包括一孔或其它腔体,杆715可穿过该孔或腔体。当拽拉杆715通过孔时,施加阻力到支撑结构722上可将间隔器720固定就位于椎突之间。由于杆715被拽拉通过孔,与杆715的近端连接的铰链结构752、753被用杆715拽拉。由于杆715被拽拉通过间隔器720,铰链结构752、753被向着间隔器720拽拉。铰链结构750-753向外转动以调整杆715和间隔器720之间的相对运动。相应地,第二翼状物760已经得以满意地展开。
第一翼状物730的铰链结构756、757可通过当拽拉间隔器720(通过支撑结构722)时施加阻力到756、757或者通过向着间隔器720推铰链结构756、757而使得第一翼状物730展开。阻力或推力可由第二止动器784施加,第二止动器784可绕支撑结构722配合并可干涉配合或者可选择地用支撑结构722固定。当第二止动器784被沿着纵向轴725推动时,沿着支撑结构722,铰链结构754-747向外转动以调整第二止动器784和间隔器720之间的相对运动。相应地,第一翼状物730已经得以满意地展开。
图19A和19B是定位在相邻椎突2、4之间的植入体700的后视图,其示出展开椎突2、4之间的植入体700的方法的实施例。植入体700可被定位,使得植入体700的分离导引器710设置在椎突2、4之间的空间。然后,植入体700可被推入椎突2、4之间,使得间隔器720如所期望地定位。植入体700的基本平坦的外廓可通过减少植入过程中可阻止植入体700运动的潜在阻碍表面,从而使得间隔器720的定位更加容易。第二翼状物760和第一翼状物730然后可展开以限制植入体700的运动。为了展开第二翼状物760,杆715在逆着沿纵向轴725插入方向的方向拽拉。第二翼状物的上端762和下端764如上所述地向外延伸。一旦第二翼状物760展开,杆715可相对间隔器720固定就位。这可通过使用多种不同的机构实现。例如,如所示出的,第一止动器782可干涉配合至杆715并沿杆715靠着支撑结构722定位。由于第一止动器782和杆715之间的摩擦配合,第一止动器782可夹持杆715,从而防止杆715通过第一止动器782和支撑结构722之间的干涉运动穿过支撑结构722的孔。在其它实施例中,可使用一些其它机构,例如销(例如开口销)、闭锁系统等。本领域普通技术人员将认识到用于将杆715相对于间隔器720固定就位的许多不同机构。上面第二结构756和下面第二结构757可通过使用如上所述的第二止动器784向着间隔器720在沿纵向轴725的插入方向推入,从而导致上面小翼731、732和下面小翼733、734向外延伸形成第一翼状物730。一旦第一翼状物730展开,铰链结构754-757可通过使用第二止动器784或一些其它机构而固定就位。第二止动器784可靠摩擦配合或销夹持支撑结构722,并阻止铰链结构754-757的运动,从而防止折叠。如上所述,本领域普通技术人员将认识到用于固定第一翼状物730在展开位置的多种不同机构。利用展开的第一翼状物730和第二翼状物760,植入体700沿纵向轴725的运动可得到限制或阻挡,从而阻止植入体700的不期望的位移。
应注意到,对于上面参照图18A-21所述的植入体,杆715可选择性地进行修整或部分分离以降低在患者脊椎中容纳植入体700、800所需的空间。例如,杆715的结构可在接近杆71 5的远端倾斜或变细,从而允许当第一和第二翼状物730、760、830、860展开并且杆715固定就位时杆715得以折断。在其它实施例中,在第一和第二翼状物730、760、830、860展开并且杆715固定就位后,可使用工具(未示出)截断杆715。此外,杆715并不必要地包括刚性结构,相反替换地可包括绳索、弹簧或类似柔性结构,其可放置在拉紧状态以保持第二翼状物760、860和/或第一翼状物730、830在展开位置。
参照图20A和20B,示出了另一根据本发明的植入体800的实施例。在该实施例中,柔性带890可连接在多副铰链结构(也就是,850和852,851和853,854和856,855和857)之间。柔性带890可限制铰链结构850-857的相对运动,使得当第一翼状物830和第二翼状物860全部展开时第一翼状物830和第二翼状物860具有增强的刚度。植入体800并不需要包括前面实施例中的支撑结构722。可施加阻力到铰链结构856、857,使得当杆715逆着沿纵向轴825的插入方向的方向拽拉时,该阻力导致铰链结构854-857向外延展以形成第一翼状物830。由于铰链结构854-857向外延展,对着铰链连接的柔性带890打开。一旦铰链结构854-857达到最大延展量,柔性带890拉紧并阻止进一步延展,将第一翼状物830锁闭就位。柔性带890可提供具有足够刚度的第一翼状物830以阻止间隔器720的运动,使得随着杆715进一步拽拉,杆715穿过间隔器720,并且与杆715连接的铰链结构852、853向着间隔器720拽拉。由于与杆715连接的铰链结构852、853向着间隔器720拽拉,所有的铰链结构850-853向外延展以展开第二翼状物860。对着铰链连接的柔性带890打开。一旦铰链结构854-857达到最大延展量,柔性带890拉紧并阻止进一步延展,从而将第一翼状物830锁闭就位。止动器882(或一些其它机构,例如销)可固定到杆715上以产生止动器882和第一翼状物830的铰链结构832、834之间的干涉,从而阻止杆715的运动。
柔性带890可由生物相容材料制成。在一实施例中,柔性带890可由编织聚酯缝合材料制成。编织聚酯缝合材料包括例如Ethibond、Ethiflex、Mersilene和Dacron,并且其为不可吸收的,具有高张力强度、低组织抗性和改进处理。在其它实施例中,柔性带890可由不锈钢(也就是,手术钢)制成,其可例如织为带。在其它实施例中,柔性带890可由一些其它具有类似属性的材料(或材料的组合)制成。
图21是定位在相邻椎突2、4之间的植入体800的后视图,其示出展开椎突2、4之间的植入体800的方法的实施例。第一翼状物830可展开以限制植入体800相对于椎突2、4的运动。为了展开第一翼状物830,杆715可被保持固定就位或在逆着沿纵向轴825的插入方向的方向推动,同时施加力到第一翼状物830的铰链结构854-857(图20A),从而导致第一翼状物的上端832和下端834从杆715向外延伸,从而展开第一翼状物830。杆715可在逆着插入方向的方向进一步推动,使得枢轴连接包括分离导引器710的铰链结构852、853的杆715的近端向着间隔器720拽拉,从而导致间隔器的上端862和下端864从杆715向外延展。一旦第二翼状物860和第一翼状物830展开,杆715可相对于间隔器720固定就位。如上,这可通过使用多种不同机构实现。例如,如所示出的,止动器882可干涉配合至杆715并靠着第一翼状物830沿杆715定位。第一止动器882可夹持杆715,从而防止杆715被第一止动器882和杆715之间的摩擦配合移动。在其它实施例中,可使用一些其它机构,例如销(例如开口销)、锁闭系统等。本领域普通技术人员将认识到用于将杆715相对间隔器720固定就位的许多不同机构。利用展开的第一翼状物830和第二翼状物860,植入体800沿纵向轴825的运动可得以限制或阻止,从而阻止植入体800的不期望的运动。
参照图22A和22B,在其它实施例中,根据本发明的植入体可包括具有圆形的折叠的第一构型和展开的第二构型的“火柴盒”状的结构。处于第一构型中,该植入体900可具有允许植入体900更自然地插入通过套管的形状。如所示出的,这种形状包括基本上圆形的截面,尽管在一些实施例中植入体可具有卵形或椭圆形截面,从而允许采用通常可适应相邻椎突之间的空间的间隔器形状。然而,将认识到,具有圆形截面的植入体900可最为充分地利用套管的空间,其中套管包括圆形截面;因此,当医生期望最小化插入手术位置的套管的直径时,可优选采用具有圆形截面的植入体900。
第一构型中的植入体900的截面大体在沿着植入体的长度方向,具有与植入体900的间隔器920的厚度基本一致的直径。植入体900可包括在植入体900的近端的分离导引器910,分离导引器910具有圆形(如所示出)或锥形的形状以穿过和/或分离相邻椎突之间的空间。然而,在使用套管将植入体传递至手术位置的地方,植入体900可选择性地包括在近端的分离导引器910。手术位置以及关联组织和结构可用套管分离和再定位,从而允许植入体900基本无障碍地通向手术位置。在这种情况下,分离导引器910可不是必需的。
植入体900还可包括多个铰链结构950-957,铰链结构950-957可折叠起来以使得便于基本上折叠起来的外廓。铰链结构950-957枢轴连接间隔器920并从间隔器920的两侧延展。杆915(或者一些其它机构,例如凸台)可与植入体900的近端连接并延伸通过铰链结构950-953,并通过间隔器920,使得杆915对医生是可接近的。
参照图22B和22C,一旦植入体900如所希望地定位在相邻椎突之间,杆915可在沿纵向轴925的逆着插入方向的方向拽拉,使得铰链结构950-957向外折叠以形成第一翼状物930和第二翼状物960,在第一翼状物930和第二翼状物960之间安置间隔器920和部分椎突。由于铰链结构950-957向外折叠,第一和第二翼状物930、960的高度从大致与间隔器920的厚度相同的高度增加到一使得第一和第二翼状物930、960可在当其定位在相邻椎突之间时限制或阻止植入体900沿着纵向轴925的运动的高度。可看出,第二翼状物960包括四个铰链结构950-953:由铰链连接至上面第二结构952的上面第一结构950、由铰链连接至下面第二结构953的下面第一结构951。铰链结构950-953向外转动以形成第二翼状物的上端962和下端964。同样,第一翼状物930包括四个铰链结构954-957:由铰链连接至上面第二结构956的上面第一结构954、由铰链连接至下面第二结构957的下面第一结构955。
如上参照图18A和18B所述的实施例包括从间隔器720延伸的支撑结构722。同样,支撑结构可选择性地从套管传递的植入体900的间隔器920延伸。然而,在套管995自身(参照图23B)防止第一翼状物930在第二翼状物960的展开过程中展开的地方,这种结构并不是必需的。参照图23A和23B,一旦套管被定位在手术位置,植入体900可被推动穿过套管,使得铰链结构950-953离开套管。然后杆915可在逆着沿纵向轴925的方向(相对于插入方向)推入以展开第二翼状物960。由于杆915被拽拉通过间隔器920,铰链结构952、953被向着间隔器920拽拉。铰链结构950-953向外转动以调整杆915和间隔器920之间的相对运动。相应地,第二翼状物960已经得以满意地展开。
一旦第二翼状物960得以展开,套管995可从手术位置收回,从而允许第一翼状物930的铰链结构956、957通过向着间隔器920推动铰链结构956、957而展开。所述推动可由止动器982施加,该止动器982可绕杆915配合并可干涉配合或选择性地与杆915固定。由于止动器982被沿着纵向轴925推动,沿着杆915,铰链结构954-957向外转动以接纳止动器982和间隔器920之间的相对运动。相应地,第一翼状物930已经得以满意地展开。
一旦第二翼状物960和第一翼状物930得以展开,杆915可相对间隔器920固定就位。如上,这可通过很多不同机构实现。例如,如所示出的止动器982可干涉配合到杆915并靠着第一翼状物930沿杆915定位。止动器982可夹持杆915,从而防止杆915通过止动器982和杆915之间的摩擦配合移动。在其它实施例中,可使用一些其它机构,例如销(例如开口销)、锁闭系统等。本领域普通技术人员将认识到用于相对间隔器920将杆915固定就位的许多不同机构。随着第一翼状物930和第二翼状物960展开,植入体900沿纵向轴925的运动可得以限制或阻止,从而阻止植入体900的不期望的位移。
应注意到,对于如上参照图22A-23B所述的植入体,杆915可选择性地进行修整或部分分离以减少患者脊椎中容纳植入体900所需的空间。例如,杆915的结构可在接近杆915的远端倾斜或变细,从而允许当第一和第二翼状物930、960展开并且杆915固定就位时截断。在其它实施例中,可在第一和第二翼状物930、960展开并且杆915固定就位后使用工具(未示出)截断杆915。此外,杆915并不必要地包括刚性结构,相反替换地可包括绳索、弹簧或类似柔性结构,其可拉紧以将第二翼状物960和/或第一翼状物930保持在展开位置。
参照图22B、22C和23B,植入体900被示出具有可操作连接的“铰链”结构950-957。该结构可以以任何允许相对运动的方式铰接。例如,该结构可通过柔性带的方式铰接,例如如上参照图20B所描述的。或者,该结构可通过一些其它技术铰接。例如,参照图24C,一个或一对绳索996可连接多副铰链结构,使得相对运动得以受限,从而允许铰链运动,同时阻止结构的分离。在其它一些实施例中,可采用一些其它机构以限定铰链结构950-957的运动范围。本领域技术人员将认识到用于限定两个机械部件的运动范围的许多不同技术。
如利用上面的柔性带890,绳索996可由生物相容材料制成。在一实施例中,绳索996可由编织聚酯缝合材料制成。编织聚酯缝合材料包括例如Ethibond、Ethiflex、Mersilene和Dacron,并且其为不可吸收的,具有高张力强度、低组织反应性和改进处理。在其它实施例中,绳索996可由不锈钢(也就是,手术钢)制成,其可例如织为带。在其它实施例中,绳索996可由一些其它具有类似属性的材料(或材料的组合)制成。
用于本发明的植入体的材料
在一些实施例中,植入体可由医用级金属例如钛、不锈钢、钴铬及其合金,或其它具有类似高强度和生物相容属性的适合的植入体材料制成。此外,植入体可至少部分地由形状记忆金属例如钛和镍组合的镍钛诺制成。这些材料是典型地不透射线的,并在X光成像和其它类型的成像中出现。根据本发明的植入体和/或其部分也可由一些柔性和/或可变形材料制成。在一些实施例中,植入体和/或其部分可全部或部分地由医用级生物相容聚合物、共聚物、混合物和聚合物组合物制成。共聚物是从超过一类单体衍生的聚合物。聚合物组合物是两种或更多材料的异相组合,其中其组分是不可混合的,因此呈现彼此之间的交接面。聚合物混合物是两种或多种不同类的聚合物的宏观均质混合物。很多聚合物、共聚物、混合物和聚合物组合物是可透射线的,在X光成像或其它类型的成像中并不显现。包括这种材料的植入体在成像下可比使用包括完全不透射线材料的植入体提供给医生更少的脊柱观察障碍。但是,该植入体并不必要地包括任何可透射线材料。
一组生物相容材料是聚芳基酯酮,其具有数个成员,包括聚醚醚酮(PEEK)和聚醚酮酮(PEKK)。PEEK被证明是耐用的植入体材料,并达到生物相容的标准。医用PEEK可从英国的兰开夏(Lancashire)的Victrex公司的产品PEEK-OPTIMA获得。医用级PEKK可从Oxford Performance Material的产品OXPEKK获得,也可从CoorsTek的产品BioPEKK获得。这些医用级材料也可作为加强聚合物树脂获得,该加强树脂甚至展示更好的材料强度。在一实施例中,植入体可由PEEK 450G制成,其是用于医疗植入的获准的未充填PEEK,可从Victrex获得。这种材料的其它来源包括位于印度的Panoli的Gharda。PEEK 450G具有以下大致属性:
属性          值
密度          1.3g/cc
Rockwell M    99
Rockwell R    126
张力强度      97MPa
弹性模量      3.5GPa
挠曲模量      4.1GPa
PEEK 450G具有适合的物理和机械属性,并适于承载和分散相邻椎突之间的物理负载。植入体和/或其部分可通过挤压、注射、压缩模塑法和/或机加工技术形成。
应注意到,所选择的材料也可被充填。充填物可加入到聚合物、共聚物、聚合物混合物或聚合物组合物以加强聚合物材料。充填物加入以改善属性,例如机械、光学和热属性。例如,为了某种用途,例如用于负载承载装置,可加入碳纤维以机械地加强聚合物,从而提高强度。在一些实施例中,其它等级的PEEK是可用的并可期望用于根据本发明的植入体,例如30%的玻璃充填或30%的碳充填等级,只要这些材料用于可植入装置是由FDA,或其它制定规章的机构认可的。相对于未充填的PEEK,玻璃充填PEEK降低延展率并增加PEEK的挠曲模量。所得到的产品对于改善强度、刚度或稳定性已知是理想的。相对于未充填的PEEK,碳充填PEEK是已知的具有提高的压缩强度和刚度和更低的延展率。碳充填PEEK也提供耐磨损和负载承载能力。
将认识到,其它适当的类似生物相容热塑或热塑缩聚物材料,其抗疲劳、具有良好的记忆,是可挠曲和/或可弯曲的,具有非常低的湿度吸收和良好的抗磨损和/或抗磨蚀,其都可使用,并不超出本发明的范围。如所提及的,植入体可包括聚醚酮酮(PEKK)。其它可用的材料包括聚醚酮(PEK)、聚醚酮醚酮酮(PEKEKK)、聚醚醚酮酮(PEEKK)和通常的聚芳基醚醚酮。此外,可使用其它聚酮以及其它热塑性塑料。可用于植入体的适当的聚合物的参考资料可参考如下文件,其在此被引用作为参考。这些文件包括:PCT公开WO02/02158A1,日期:2002年1月10日,标题:Bio-CompatiblePolymeric Materials;PCT公开WO02/00275A1,日期:2002年1月3日,标题:Bio-Compatible Polymeric Materials;和PCT公开WO02/00270A1,日期:2002年1月3日,标题:Bio-Compatible Polymeric Materials。其它材料,例如Bionate聚碳酸酯聚氨酯,其可从加利福尼亚州的伯克利Polymer Technology Group获得,其由于其良好的氧化稳定性、生物相容性、机械强度和抗磨损也是适合的材料。其它热塑材料和其它高分子重聚合物也可使用。
如上所述,粘合剂可用生物相容材料制成。在一实施例中,粘合剂可由编织聚酯缝合材料制成。编织聚酯缝合材料包括,例如,Ethibond、Ethiflex、Mersilene和Dacron,并且其是不可吸收的,具有高张力强度、低组织反应和改进处理。在其它实施例中,粘合剂可由不锈钢(也就是手术钢)制成,其可例如植入绳索或织为带。在其它实施例中,粘合剂可由其它具有类似属性的材料(或材料的组合)制成。
可理解的是,根据本发明的实施例可不由柔性材料构建。同样可理解的是,根据本发明的实施例可具有其它尺度。
植入椎间植入体的方法
在此公开和教导了将植入体400植入到颈椎中的最小侵入手术方法。在该方法中,如图24所示,优选地将引线80穿引通过定位网状物或导引90,进入植入体接收者的颈部。引线80可用于定位植入体相对于包括椎突的颈椎的放置位置。一旦引线80在影像技术的帮助下得以定位,则在颈部侧面作一切口,使得根据本发明的实施例的植入体可穿过切口并沿约垂直于引线80的直线且向着引线80的末端而被定位在颈部。在一实施例中,植入体可为一尺寸适合的植入体400(也就是,具有不可分离的主体),如图1-17所示,并包括分离导引器110、间隔器120和第一翼状物130。植入体400被插入患者的颈部。优选地在插入过程中,分离导引器110穿过或分离组织而不需要切断组织。
一旦植入体400得以满意地定位,第二翼状物460可选择性地沿着与植入体400被插入的线基本共线的线但是从颈部的相反侧插入。颈部的解剖是使得最为方便并最小侵入以从关于植入体400和第二翼状物460的一侧进入颈部。第二翼状物460是与植入体配对的,并且在这一特定的实施例中,第二翼状物460通过使用紧固件例如螺钉442固定至植入体400。在使用螺钉的地方,螺钉442可通过使用沿着从后到前的与引线80有点平行的线定向的螺钉驱动机构定位。该从后到前的线帮助医生观察和固定第二翼状物460到植入体。第二翼状物460得以定位,使得形成在第二翼状物460的唇状物461中的孔463与植入体400的孔440对齐,如上所述。螺钉442定位在两个孔中,并至少固定至植入体400的孔440。在其它实施例中,第二翼状物可与植入体干涉配合,如上所述,或者使用一些其它机构例如柔性铰链和突起进行固定。
在此公开和教导将植入体700的替换实施例植入颈椎中的最小侵入手术方法。在这种方法中,如图25所示,优选地将引线80插入穿过定位网状物或导引90进入植入体接收物的颈部。引线80可用于定位将植入体700相对于包括椎突的颈椎放置的地方。一旦引线80在影像技术的帮助下得以定位,则在颈部侧作一切口,使得根据本发明的实施例的植入体700可穿过切口并沿约垂直于引线80的直线且向着引线80的末端而被定位在颈部。在一实施例中,植入体700可包括分离导引器710、间隔器720和从间隔器720延伸的杆715以及可展开的第一和第二翼状物730、760。植入体700可具有基本平坦的外廓以易于植入,如上所述。植入体700被插入患者的颈部。优选在插入过程中,分离导引器710穿过或分离组织而不需要切断组织。
一旦植入体700得以满意地定位,第一翼状物730和第二翼状物760可以展开。如上所述,第二翼状物760可通过与沿着纵向轴725的插入方向相反的方向推动杆715而得以展开。由于杆715穿过间隔器720,铰链结构750-753接触间隔器720,扣住杆715并从杆715延伸,二者形成第二翼状物的上端762和下端764。当第二翼状物760得以满意地展开时,杆715可通过使用第一止动器782、销或一些其它机构相对于间隔器720固定就位。第一翼状物730可通过向着间隔器720推动铰链结构754-757而展开,从而导致铰链结构754-757彼此扣住并从彼此延伸,从而形成第二翼状物的上端732和下端734。颈部的解剖是这样以使得最为方便和最小侵入地从关于植入体700的侧面进入颈部。
在此公开和教导将植入体900的替换实施例植入颈椎中的最小侵入手术方法。在这种方法中,如图26所示,优选地将引线80穿过定位网状物或导引90插入进入植入体接收者的颈部。引线80可用于定位将植入体900相对于包括椎突的颈椎放置的地方。一旦引线80在影像技术的帮助下得以定位,则在颈部侧面沿着约垂直于引线80且向着在引线80的末端的直线作一切口。套管995通过切口推入并定位在目标的相邻椎突之间。在一实施例中,植入体900可包括分离导引器910、间隔器920、从间隔器920延伸的杆915和可展开的第一和第二翼状物930、960。植入体900可具有基本圆形的截面以与套管995的内表面基本一致。植入体900被推动穿过套管995并进入相邻椎突之间的位置,使得第二翼状物960铰接结构脱离套管995,如上参照图23B所述。第二翼状物960然后通过在与沿着纵向轴925的插入方向相反的方向推动杆915而展开。由于杆915穿过间隔器920,铰链结构950-953接触间隔器920,扣住并从杆915延伸,二者形成第二翼状物的上端962和下端964。当第二翼状物960得以满意地展开时,套管995可被收回以露出第一翼状物930的铰链结构954-957。第一翼状物930可通过向着间隔器920推动铰链结构954-957而展开,从而导致铰链结构954-957彼此扣住并从彼此延伸以形成第二翼状物的上端932和下端934。一旦第一翼状物930得以展开,杆915可选择性地缩短,并且套管995可从切口抽出。切口然后可得以闭合。
本发明的前面的说明已经为示出和描述的目的而进行了介绍。这并不是意在穷举的或者是限制本发明在所公开的确切形式。很多修改和变化对于本领域的实施技术人员来说是明显的。为了最好地解释本发明的原理及其实际应用,选择和描述了实施例,从而使得本领域技术人员能够理解本发明,不同的实施例和不同的修改是适于特定的预期用途的。本发明的范围只由权利要求及其等同物而限定。

Claims (20)

1.一种适于插入椎突之间的椎间植入体,该植入体包括:
具有厚度的间隔器;和
从间隔器延伸的翼状物,该翼状物具有第一构型,并且该翼状物可选择地可设置在第二构型中;
其中,在第一构型中所述翼状物具有与所述间隔器厚度大致相同的高度;
其中,在第二构型中所述翼状物具有大于所述间隔器厚度的高度。
2.如权利要求1所述的植入体,还包括:
延伸通过间隔器的杆,该杆用于当相对于间隔器移动时可选择地将所述翼状物设置在第一构型和第二构型。
3.如权利要求1所述的植入体,其中:
所述翼状物是第二翼状物;和
所述植入体还包括:
从所述间隔器延伸的第一翼状物,该第一翼状物具有第一构型,并且该第一翼状物可选择地设置在第二构型中。
4.如权利要求3所述的植入体,其中:
在所述第一构型中,所述第一翼状物具有与所述间隔器厚度大致相同的高度;
在所述第二构型中,所述第一翼状物具有大于所述间隔器厚度的高度。
5.如权利要求1所述的植入体,其中,在所述第一构型中所述翼状物是一分离导引器。
6.如权利要求1所述的植入体,其中,所述翼状物包括具有枢轴连接到第二上铰链结构的第一上铰链结构的上端和具有枢轴连接到第二下铰链结构的第一下铰链结构的下端的之一或两者。
7.如权利要求2所述的植入体,其中,所述杆通过销、止动器和夹子的至少之一相对于间隔器固定就位。
8.如权利要求6所述的植入体,还包括:
下面之一或两者:
第一带,其连接在第一上铰链结构和第二上铰链结构之间,所述第一带适于限制第一上铰链结构相对于第二上铰链结构的枢轴运动,和
第二带,其连接在第一下铰链结构和第二下铰链结构之间,所述第二带适于限制第一下铰链结构和第二下铰链结构的枢轴运动。
9.一支撑相邻椎突的系统,该系统包括:
植入体,该植入体包括:
具有厚度的间隔器;
翼状物;
其中所述翼状物的第一构型具有实质上类似于该厚度的第一高度;
其中所述翼状物适于可选择地设置在第二构型中,使得所述翼状物具有大于第一高度的第二高度;
套管,该套管具有可定位在相邻椎突之间的近端;和
其中当所述翼状物设置在第一构型中时,所述植入体的外表面具有基本上与所述套管的内表面的形状一致的形状和小于所述套管的内径的截面直径。
10.如权利要求9所述的植入体,还包括:
延伸通过间隔器的杆,该杆适于当相对于间隔器移动时可选择地将至少第二翼状物设置在第一构型和第二构型。
11.如权利要求9所述的植入体,其中:
所述翼状物是第二翼状物;和
所述植入体还包括:
从所述间隔器延伸的第一翼状物,该第一翼状物具有第一构型,并且所述第一翼状物可选择地设置在第二构型中。
12.如权利要求11所述的植入体,其中:
在第一构型中所述第一翼状物具有与间隔器厚度大致相同的高度;
在第二构型中所述第一翼状物具有大于间隔器厚度的高度。
13.如权利要求9所述的植入体,其中,在第一构型中所述第二翼状物是锥形以使得所述第二翼状物是分离导引器。
14.如权利要求9所述的植入体,其中:
所述第一和第二翼状物包括具有与第二上铰链结构枢轴连接的第一上铰链结构的上端和具有与第二下铰链结构枢轴连接的第一下铰链结构的下端的之一或两者。
15.如权利要求10所述的植入体,其中,所述杆通过销、止动器和夹子的至少之一相对于间隔器固定就位。
16.如权利要求14所述的植入体,还包括:
下面的之一或两者:
第一带,其连接在第一上铰链结构和第二上铰链结构之间,所述第一带适于限制第一上铰链结构相对于第二上铰链结构的枢轴运动,和
第二带,其连接在第一下铰链结构和第二下铰链结构之间,所述第二带适于限制第一下铰链结构和第二下铰链结构的枢轴运动。
17.一种设置植入体在相邻椎突之间的方法,该方法包括:
将套管的近端插入手术位置;
将所述近端定位在相邻椎突之间;
通过推动植入体穿过套管而将植入体定位在相邻椎突之间,所述植入体包括具有厚度的间隔器和翼状物,其中所述翼状物的第一构型具有实质上类似于该厚度的第一高度;
推动所述植入体至少部分地通过近端,使得所述间隔器设置在相邻椎突之间;
将所述翼状物重新设置为第二构型,使得所述翼状物具有大于第一高度的第二高度;
从手术位置撤出套管。
18.如权利要求17所述的方法,其中,所述翼状物是第二翼状物,所述植入体还包括第一翼状物,其中第一翼状物的第一构型具有实质上类似于该厚度的第一高度;
所述方法还包括:
撤出所述套管,使得所述第一翼状物暴露在手术位置;
将第一翼状物重新设置为第二构型,使得所述翼状物具有大于第一高度的第二高度。
19.如权利要求18所述的方法,其中,所述将翼状物重新设置为第二构型包括当基本上将植入体保持就位时在与所述推动方向相反的方向推动与植入体可操作地连接的杆。
20.如权利要求19所述的方法,还包括:
将所述杆固定就位,从而将翼状物保持在第二构型中。
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US20080045958A1 (en) 2008-02-21
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EP1871303A2 (en) 2008-01-02
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WO2006113080A2 (en) 2006-10-26
US7959652B2 (en) 2011-06-14
US20080046085A1 (en) 2008-02-21
AU2006237509B2 (en) 2012-02-02
US8128702B2 (en) 2012-03-06
CA2606260A1 (en) 2006-10-26
KR20080039834A (ko) 2008-05-07
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US8109972B2 (en) 2012-02-07
US20060271049A1 (en) 2006-11-30

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