CN101636119A - 分节髓内结构 - Google Patents

分节髓内结构 Download PDF

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CN101636119A
CN101636119A CN200880008990A CN200880008990A CN101636119A CN 101636119 A CN101636119 A CN 101636119A CN 200880008990 A CN200880008990 A CN 200880008990A CN 200880008990 A CN200880008990 A CN 200880008990A CN 101636119 A CN101636119 A CN 101636119A
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cable
body segment
primary importance
locking mechanism
intramedullary
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J·D·斯通伯纳
M·T·哈蒙
R·特里普
C·E·拉森
D·F·贾斯廷
K·E·莫尔
C·J·克雷格
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Osteolign Inc
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Osteolign 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
    • 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
    • A61B17/72Intramedullary pins, nails or other devices
    • A61B17/7208Flexible pins, e.g. ENDER pins
    • 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
    • A61B17/72Intramedullary pins, nails or other devices
    • A61B17/7233Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • A61B17/7258Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
    • A61B17/7266Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with fingers moving radially outwardly
    • 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8869Tensioning devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1717Guides or aligning means for drills, mills, pins or wires for applying intramedullary nails or pins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1725Guides or aligning means for drills, mills, pins or wires for applying transverse screws or pins through intramedullary nails or pins
    • 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
    • A61B17/72Intramedullary pins, nails or other devices
    • A61B17/7283Intramedullary pins, nails or other devices with special cross-section of the nail
    • 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/92Impactors or extractors, e.g. for removing intramedullary devices
    • A61B2017/922Devices for impaction, impact element
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/45For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4504Bones
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/53Means to assemble or disassemble
    • Y10T29/53796Puller or pusher means, contained force multiplying operator

Abstract

本发明公开了一种适于容放在长骨的髓腔中的可植入髓内固定结构(10),所述结构包括多个长型体节(12)。每个体节具有第一端部和形状互补的第二端部(24),以便体节的第一端部(22)和相邻体节的第二端部协调地接合。所述体节限定引导孔隙,从而能够容放在用于在髓腔中定位的引导件(32)上。

Description

分节髓内结构
相关申请的交叉引用
[0001]本申请要求在2007年3月22日申请的美国临时申请序列号60/896,342的申请日的利益,其全部内容通过引用结合于此。
技术领域
[0002]本发明涉及一种骨科假体,并且更特别地涉及一种通常称为髓内钉或IM钉的可植入结构,其适于容放在髓腔(intramedullarycanal)中用于治疗长骨骨折。
发明内容
[0003]在一个实施方式中,本发明的髓内结构采用多个体节,优选地,所述多个体节被导入到髓腔内的引导构件上,所述引导构件已经通过经由皮肤的进入孔预先被导入到髓腔内。优选地,每个体节构造为该体节与其相邻的体节相互连接。同样优选地,长型拉紧构件被容放在所述体节的内部,并被固定到端部的体节上,从而将所有所述体节一起固定在所述结构中。在一个实施方式中,所述引导构件为金属丝或缆索,所述金属丝或缆索也用作所述拉紧构件。
[0004]更具体地,每个体节可以具有孔隙,所述孔隙是开口的内部的形式,从而所述体节能够被穿到引导构件或拉紧构件上。所述体节还具有相对的端部,所述端部优选为具有互补的形状,使得第一体节的端部适于与其相邻的第二体节的端部协调地接合。优选地,每个体节具有公端和形状互补的母端。
[0005]通过参考所附附图和说明书,其它特征和方面将得以阐明。
附图说明
[0006]图1为根据本发明的第一实施方式的诸如钉的组装的分节髓内结构的立体图。
[0007]图2为图1的髓内钉的单个体节的立体图。
[0008]图3为图2的体节的纵向剖面图。
[0009]图4为采用单个钉的体节的第二实施方式的髓内钉的立体图。
[0010]图5和6为使用在髓内结构中的单个体节以及被容放在引导构件上的多个这样的体节的第三实施方式的立体图。
[0011]图7和8为单个体节以及被容放在引导构件上的多个这样的结构的第四实施方式的立体图。
[0012]图9和10为单个体节以及安装在一起的多个这样的体节的第五实施方式的立体图。
[0013]图11和12为使用在髓内钉中的体节的第六实施方式的立体图,其中多个周缘杆被使用在组装的钉中。
[0014]图13为IM钉的第七实施方式的立体图,其中各个体节通过铰链构件彼此连接,从而所述钉能够经过进入孔而被插入到髓腔内,进入孔倾斜于髓腔的轴线。
[0015]图14-22示意性地显示了用于将根据本发明的分节髓内钉安装到长骨的髓腔内的过程。
[0016]图23为用于植入髓内骨折固定装置的系统的立体图,髓内骨折固定装置包括可植入骨折固定装置、螺钉引导装置以及缆索拉紧件。
[0017]图24为显示于图23中的可植入髓内骨折固定装置的正视图。
[0018]图25为显示于图24中的可植入骨折固定装置的最近端体节的正视图。
[0019]图26为显示于图24中的可植入骨折固定装置的典型中间体节的正视图。
[0020]图27为显示于图24中的可植入骨折固定装置的最远端体节的正视图。
[0021]图28和29为显示于图26中的中间体节的立体图。
[0022]图30和31为显示于图25中的最近端体节的立体图。
[0023]图32为图23的可植入骨折固定装置的远端部分的剖面图,显示了最远端体节的细节。
[0024]图33为形成最远端体节的一部分的扩张件的立体图。
[0025]图34为螺钉引导接口的立体图,所述螺钉引导接口适于安放在显示于图23中的可植入骨折固定装置的近端端部上。
[0026]图35为螺钉引导接口和显示于图24中的骨折固定结构的近端端部的剖面图。
[0027]图36为缆索拉紧件的放大的立体图。
[0028]图37为显示于图36中的缆索拉紧件的剖面图。
[0029]图38为缆索拉紧件和骨折固定装置的近端端部体节的配合结构的放大的剖面图。
具体实施方式
[0030]根据本发明,所提供的髓内结构适于容放在诸如胫骨的长骨的髓腔中。所述结构包括多个长型体节,每个体节具有第一端部和形状互补的第二端部,从而体节的第一端部和相邻体节的第二端部协调地连接。优选地,所述体节限定一个引导金属丝的孔隙,从而可被容放在用于导入到髓腔内的引导金属丝或缆索上。可选地,所述结构可以包括拉紧构件,所述拉紧构件为例如沿着其长度延伸的缆索或杆的形式,所述拉紧构件与所述结构的最末端体节配合,以提供沿着所述结构的纵向轴线的压缩力,从而使所述结构的刚度提高。
[0031]参考图1,显示了分节髓内结构10的第一实施方式。所显示结构包括八个体节12,体节12容放在可选的拉紧杆14上,从而提供总体长度大约175mm的髓内结构10。当然,体节12的数目和钉的总体长度将取决于其将要插入的髓腔的长度。
[0032]如图所示,拉紧杆14的端部16具有螺纹,并且体节12通过互补的螺纹构件(显示为螺母18和垫圈20)而被保持在拉紧杆14上,所述互补的螺纹构件被容放在拉紧杆14的螺纹端部16上。然而,可以采用将体节12固定到拉紧杆14的替代方法,例如被容放在拉紧杆上并位于端部体节的开口的内部的型铁接头(swage fitting),或者容放在拉紧杆上与端部体节连接的压铆螺母(press nut)。
[0033]图2和3显示了图1所示的髓内结构的单个体节12。图2和3所示的单个体节12的具体结构仅是用作实例。体节12包括公端22和母端24,公端22具有截头圆锥体的外部形状,母端24具有圆柱形的外部形状以及与公端22的外部形状互补的截头圆锥体的内部形状。
[0034]优选地,体节12的总体长度不大于大约32mm,这使体节12可以相对容易地经过10mm的经由皮肤的进入孔而导入到髓腔内,经由皮肤的进入孔定向为相对于骨的轴线大约为30度。体节12的最大外径由髓腔的内径所决定,并且典型地大约为9mm。体节的公端22的内径大约为3.6mm,这使得3mm的引导金属丝或缆索容易从中穿过。
[0035]体节12由诸如钛的具有足够刚度和强度的生物相容性材料构成。母端24的内表面和公端22的外表面可以是光滑的(“镜面抛光的”),以便于套接。母端24的外表面可以是粗糙的或者带有纹理的(“压花的”),以促进组织在其上生长。
[0036]在所示实施方式中,相邻体节12通过母端的内表面和公端的外表面之间的摩擦配合而彼此固定。然而,如果需要,通过为体节提供机械互锁结构,例如槽和销、分叉部、凸出部、螺纹等,能够得到更为有力的互锁。体节还可以构造为在组装时防止体节之间的旋转运动。这可以例如通过为公端的外表面和母端的内表面提供互补的非圆形横截面而实现,非圆形横截面例如为带有圆角的正方形。可替代地,或者另外,一旦体节在髓腔中安放到位,骨接合剂或者其它可硬化的外科流体就可以被导入到体节的内部,从而为组件提供额外的结构整体性,并有助于将组装的结构固定到位。
[0037]图4显示了根据本发明的利用单独的体节12A的第二实施方式的IM结构。体节12A的公端22A包括具有外螺纹的支脚(standoff),该支脚被容放在相邻体节12A的具有互补的内螺纹的母端24A中。
[0038]图5和6公开了根据本发明的用于IM结构的体节12B的第三实施方式。体节的公端22B包括分叉部26,分叉部26在其远端端部具有肩部或棘爪28,肩部或棘爪28提供与相邻体节12B的形状互补的端部24B的卡扣配合。位于公端和母端两者的周缘上的一系列互相配合且隔开的凸出部30用于将体节对齐,并用来防止体节12B相对彼此转动。当被导入到髓腔内时,各个体节优选为被容放在杆或引导金属丝32上,以便于这些体节的配合连接。
[0039]图7和8公开了使用在IM结构中的体节12C的第四实施方式,其类似于图4和5的实施方式。然而,体节12C的突出部、分叉部和棘爪的互锁结构更为精细。
[0040]图9和10显示了根据本发明的用于IM结构的体节12D的第五实施方式。体节的公端22D呈现了多个纵向花键,所述纵向花键具有在外形上类似于齿轮的横截面。母端24D具有互补的齿轮形状,并包括同心环34,同心环34提供与公端22D的内径的紧密配合。可以意识到,该结构也提供了相对于彼此不可旋转的相互配合的体节。
[0041]图11和12显示了根据本发明的使用在IM结构中的体节12E的第六实施方式。体节12E在结构上大体为圆柱形,并在其公端和母端22E、24E上具有互补的相互配合的凸出部30E。体节12E还包括位于体节的壁中的多个隔开的纵向通孔36(显示了四个这样的通孔36)。通孔36容放长型周缘杆38,周缘杆38为组装的IM结构提供额外的刚度和强度。
[0042]参考图13,显示了IM结构62的另一个实施方式。结构62包括多个体节64,体节64通过铰链构件66而彼此连接。铰链66允许体节相对于彼此枢转,以便于将该结构经过成角度的进入孔而导入到髓内钉中。如图所示,IM结构由具有多个V形切口的单个圆柱形构件形成,V形切口沿着该结构的长度以规则的间距被切出,形成所述圆柱形构件的材料于每个切口的顶点处在相邻体节之间提供了“天然的铰链”。一旦被插入到髓腔内,骨接合剂就被导入,以使IM结构保持笔直,并进一步提供结构整体性。
[0043]图14-22示意性地显示了将根据本发明的分节髓内结构插入到诸如胫骨的长骨42的髓腔40内的过程。
[0044]参考图14,所显示的长骨42在其近端和远端端部的中间具有骨折44。进入孔46被制成经由皮肤以倾斜于长骨的轴线或中心线的角度,并且优选为以相对于长骨的轴线大约为30度的角度,在髓腔40的近端端部处进入到髓腔40内。进入孔46的直径允许导入包括髓内结构的单独的体节12。在本发明中,进入孔46的直径大约为10mm。在制成进入孔46后,引导金属丝或缆索32经由进入孔46而被插入,并且前进到髓腔40内,并穿过骨折位置44而到达髓腔40的远端端部。
[0045]参考图15,显示了第二步骤,其中第一或最远端体节12被装在引导金属丝上,并且通过经由皮肤的进入孔46而前进到髓腔40内。如图16所示,体节12被推动经过进入孔46并借助于插入件48而沿着引导金属丝32前进,插入件48也装配在引导金属丝32上。插入件48具有与其连接的带孔锤50,从而当体节12前进到髓腔40内时,带孔锤50向其施加额外的推力。
[0046]参考图17,一旦体节12被定位到髓腔40内,它就通过挠性推动杆52而沿着引导金属丝32前进到IM腔40的远端端部。重复如图15-17所示的将体节12插入到引导金属丝上并使其沿着引导金属丝向远端前进的步骤,直到制成预期的长度的IM结构。参考图18,IM结构具有十三个体节。因此图15-17的步骤被重复了十二次。
[0047]参考图19,IM结构被固定到IM腔的远端端部。为此目的,最远端和最近端的体节包括用于容放骨螺钉的通孔。利用用于引导的荧光检查法,锁定螺栓54经由皮肤而被导入,并经过最远端和最近端体节中的孔而前进。在所示的方法中,引导金属丝32被保留在其位置。然而,如果各个体节包括有力地互锁的IM钉,那么在所有包括IM钉的体节都相互连接之后,可以移走引导金属丝32。参考图20,锁定螺母56被插入到引导金属丝32上,并被插入到最近端体节内,挠性驱动件58被用于将螺母56紧固到指定扭矩。引导金属丝32的露出部分随后被切除(图21),并且经由皮肤的锁定螺栓60被用于将最近端体节固定到位(图22)。可以使用除了锁定螺栓、固定螺钉或其它紧固件的装置,例如骨接合剂或其它可硬化的外科流体,或者径向可扩张的元件,从而将IM结构在髓腔中固定到位。
[0048]参考图23-39,公开了一般地由100表示的分节髓内系统的另一实施方式。系统100包括三个基本部件:可植入分节髓内骨折固定装置结构102、近端固定螺钉引导接口104以及缆索拉紧件组件200。
[0049]参考图24-26,可植入固定结构102包括多个基本相同的互相配合的中间体节108(显示为九个),具有适于容放固定螺钉的多个孔或通孔112的近端端部体节110,以及径向可扩张的远端端部体节114。缆索116被固定到远端端部体节,延伸经过可植入结构而超出近端端部体节116,并延伸经过缆索拉紧件200,从而向各个体节施加压缩力,进而实现刚性植入。接近于远端端部的体节108、110的每一个都具有开口的内部,从而允许拉紧缆索116穿过其中,并允许各个体节在插入到髓腔内的过程中沿着缆索116滑动。
[0050]近端端部体节110和中间体节108是预先组装的,同时各个体节铰接地彼此固定。为了便于将固定结构102插入到长骨的首部,在该处,用于植入件的进入点偏离长骨的轴线,可植入结构的各个体节108、110构造为仅轴向地和在单个平面中横向地可相对运动。为此目的,参考图26、28和29,中间体节108具有相互配合的公部分118和母部分120,其分别包括三个基本平的面(公部分的118a、118b和118c以及母部分的120a、120b和120c)。面118a、120a分别地基本平行于面118c、120c,同时面118b、120b分别基本垂直于面118a、118b和120a、120b。第四面118d、120d相对于体节的纵向轴线倾斜地定向。相邻表面通过弓形表面连接。三个平的表面保证组装的结构基本仅在大致平行于各个体节的公部分和母部分的平行面的平面内是挠性的。
[0051]经验显示,当具有光滑或规则锥形或圆锥表面的构件套接时,锥形表面具有锁在一起的趋势。当然,这在本结构中是不利的,因为这会导致对于插入到髓腔内以及从髓腔移出所需的可植入结构的挠性降低。从而,体节108的公部分和母部分118、120的倾斜定向的表面118d、120d具有一系列台阶122,台阶122具有基本平行于体节轴线的表面。这保证了如果在缆索116上未施加拉力且固定结构102未处在压缩下时,各个体节的配合部分会自由地滑动分离。
[0052]所述结构的各个体节108、110彼此固定为允许相对于相邻体节的受限的轴向运动,并保证体节的公部分与相邻体节的母部分的表面的正确定向。在本实施方式的结构中,这通过为体节的母部分120提供销124(最好参见图28)来实现,销124所在的平面垂直于组装的植入件弯曲的平面。销124经过其连接的体节的母部分120的开口的内部而延伸,并且被接收在邻近的相邻体节的公部分118中的沿轴向定向的长槽126中。如图所示,槽126在远端端部比近端端部更宽,为扩张的可植入结构提供更大的挠性。当然,销可以由体节的公部分118所携带并支撑在母部分120中的槽中,已实现同样的结果。
[0053]近端端部体节110具有用作拉紧缆索的通道的开口的内部,并包括两部分:弓形部分128和配合部分130,后者具有如上所述的公部分118,用于安放在紧邻的远端中间体节的母部分120中。为便于将可植入结构的近端端部固定到骨上,所述弓形体节包括多个通孔112(显示为三个),通孔112定向为基本垂直于可植入固定结构102的轴线,用于容放骨螺钉(未显示)。通孔112定位为不与弓形部分的开口的内部相交,由此保证了拉紧缆索116不会与固定螺钉接触。
[0054]弓形部分128的近端端部构造为容放用于锁定拉紧缆索116的两部分的远端筒夹组件132(图35和39)(如后面更详细地描述),还构造为以预定方向安放螺钉引导接口104。
[0055]如结合前面的实施方式所描述的,可植入结构的远端部分可以构造为通过骨螺钉或通过骨接合剂固定到骨上。然而,在本实施方式中,优选地,通过使最远端体节140为径向可扩张从而与髓腔的表面接合,来实现可植入结构到长骨的远端部分的固定。为此目的,参考图27、32和33,远端体节140包括扩张构件142,扩张构件142在其内部容放楔构件144。楔构件144被固定到拉紧缆索的远端端部,从而在缆索116上施加拉力时,楔构件144被向近端移动进入到扩张构件142内,以使扩张构件142沿径向扩张为与髓腔的表面接合。
[0056]所示的扩张件142包括上颈圈部分146,多个均匀地沿径向隔开的支脚148(显示为四个)以悬臂方式从颈圈部分146下垂。在其无形变的状态,扩张件142的径向尺寸不大于可植入固定结构102的其它体节108、110的径向尺寸,从而便于插入到髓腔内。楔构件144的形状基本为圆锥形,并且在其表面具有长型凹槽150,用于安放扩张件142的支脚148。优选地,凹槽150的横截面形状与支脚148的内表面互补。
[0057]为了增强所述扩张件在髓腔中的锚固,所述支脚的外表面具有设计为更易于穿入到髓腔的骨表面内的结构。这种结构可以采用点或者狭窄边缘或者刃片状结构的形式。在所示的实施方式中,每个支脚的外表面都具有连续隆起的脊部152。优选地,脊部152具有波浪形或之字形构造,这对嵌入的扩张件142的轴向和旋转运动提供了阻力。
[0058]如上文所注意到的,在本实施方式中,近端端部体节110包括三个通孔112,用于容放骨螺钉,从而将植入件102的近端端部固定到位。为便于定位所述螺钉,近端体节110适于安装有螺钉引导接口104。如图34和35最好地看到的,螺钉引导件104包括一对下垂臂154、156,第一臂154安装有一对引导管158、160,且第二臂156安装有单个引导管162。当螺钉引导接口104被固定到植入件102的近端端部体节110时,引导管158、160、162与通孔112对准。臂154、156的上端部连接在一起,同时管状体节164从臂154、156的接合点向下下垂。管状体节164的下端部和近端体节110的上端部构造为使螺钉引导接口104以正确方向安放在近端体节110上,同时螺钉引导管156、160、162与其预期的通孔112对准。一旦正确地安放,螺钉引导接口104就通过插入引导件166而被固定于植入件。插入引导件166具有放大的夹持表面168以及下垂的管状部分170。插入引导件166的夹持表面168安放在螺钉引导接口104的凹陷部分中,同时插入引导件166的管状部分170延伸经过螺钉引导接口104的管状体节164,从而被容放在植入件102的近端体节110的近端端部中。插入引导件166的管状部分170的远端端部具有外螺纹,而近端体节110的近端端部的内表面具有内螺纹。因而,插入引导件166可以被拧到近端端部体节110内,从而将螺钉引导接口104固定到可植入固定装置102上的适当位置。
[0059]拉紧件工具组件可以被用来调节和/或锁定所述固定装置中的缆索上的拉力。拉紧件工具组件可以包括缆索、锁定部件、拉紧件以及锁定机构调节器。参考图36,显示了拉紧件工具组件200的一个实施方式的立体图。可以意识到,拉紧件工具组件200可以用来为如上所述的连接到分节髓内骨折固定装置的缆索、线绳、绳索或其它弹性构件提供并调节拉力,或者可以用来为其它植入件、装置或系统提供并调节拉力。当与诸如固定装置102的分节髓内骨折固定装置一同使用时,拉紧件工具组件200可以在缆索116(被连接到所述固定装置并从固定装置延伸,未显示)上被引导,并且可释放地被连接到装置的近端端部。近端筒夹螺钉、拉紧件和包括缆索筒夹螺钉的远端筒夹组件可以被依次调节,从而获得并且锁定所述固定装置中的缆索上的处于最佳水平的拉力。然后,可以移走拉紧件工具组件200,并且可以切除延伸到固定装置200的外部的缆索,同时固定装置内部的缆索保持最佳的拉力。
[0060]拉紧件工具组件200的实施方式包括近端筒夹210,近端筒夹210与螺纹轴220接合。近端筒夹的远端是部分延伸到外壳230内的螺纹旋钮240。外壳230的形状为可停靠在插入引导件166中,引导件166可以连接到所述固定装置的近端端部。筒夹驱动件250被接收在外壳内,并构造为在外壳内可旋转。在插入引导件和固定装置之间的连接之内的是远端筒夹组件132。缆索孔202在组件200的整个长度内沿着直线路径纵向延伸。
[0061]当将拉紧件工具组件200连接到固定装置102时,首先可以在缆索116上引导所述插入引导件166,并将其连接到固定装置102,随后,在缆索116上引导拉紧件工具组件200的其余部分,并经由外壳230而将所述其余部分停靠在插入引导件166内。可替代地,拉紧件工具组件200可以首先停靠到插入引导件166,并且随后在缆索116上引导整个组件,并将整个组件连接到固定装置102。螺纹或者其它连接部件可以提供接口,从而将外壳230停靠到插入引导件166。
[0062]参考图37,显示了拉紧件工具组件200的纵向局部剖视图。为了清楚区分拉紧件工具组件的各部件,所以未显示缆索。可以看到,缆索孔202沿着直线路径延伸组件200的长度。螺纹旋钮240具有带有内螺纹的管腔242,螺纹轴220经过管腔242延伸。螺纹轴220经过管腔242从螺纹旋钮240的近端端部延伸到外壳230中。轴220穿过的横杆232可以提供抗旋转部件,防止该轴进行旋转。保持部件221可以将螺纹轴的远端端部保持在外壳内,防止螺纹轴从管腔242意外退回。螺纹轴220具有沿着其外部延伸一定距离的外螺纹222。在螺纹轴220的近端端部是较短部分的内螺纹224,并且在内螺纹224的远端的是具有锥形壁228的腔室226。
[0063]近端筒夹210配合进入到螺纹轴220的近端端部内。外螺纹212与螺纹轴上的内螺纹224接合,从而支撑筒夹210。多个挠性指状部214从筒夹210向远端延伸进入到腔室226。如前所述,拉紧件工具组件200在缆索116(未显示)上被引导,并且缆索延伸经过缆索孔202并延伸到近端筒夹210的近端端部之外。近端筒夹210为锁定部件,通过将近端筒夹210拧到螺纹轴220内,该锁定部件可以被锁定到缆索上的位置。当筒夹210被拧入时,指状部214向远端前进到腔室226内。当指状部214向锥形壁228偏压时,指状部214被推进到一起,接合并限制缆索,直到缆索被固定地夹持。当指状部214与缆索接合时,它们可以沿周向环绕缆索。在此位置,缆索被锁定并可防止沿任何方向拉动缆索。然而,通过简单地将筒夹210从螺纹轴220内拧松,从而指状部214能够自由地向外弯曲并从缆索松开,缆索又能够自由地移动。注意到在锁定过程中,缆索116保持在组件200内基本沿着直线路径定向,并且不会弯曲、转弯、卷曲或变坚硬(severed)。
[0064]一旦缆索被锁定,拉紧件可以被调节,从而调整缆索的拉力。拉紧件可以包括外壳230、螺纹旋钮240、螺纹轴220、横杆232以及保持部件221。螺纹旋钮240可以通过转动其而被调节,从而向缆索提供拉力。当旋钮240被转动时,内螺纹244与螺纹轴220上的外螺纹222接合,并且由于旋转运动被转换为直线运动,旋钮240向远端移动,同时螺纹轴220向近端移动。由于缆索被连接到远端端部体节处的第一位置处的固定装置,并且被锁定在处于第二位置处的轴220内的筒夹210内,从而向近端移动轴220就会相对于固定装置移动筒夹210,并且在所述固定装置处的第一位置和所述筒夹处的第二位置之间的缆索上施加拉力。
[0065]当旋钮240向远端移动时,所述旋钮的远端面246推动弹簧248,弹簧248环绕外壳230中的螺纹轴220。当进一步转动旋钮240时,弹簧248在旋钮远端面246和形成在外壳230的壁中的唇缘234之间被压缩。该压缩可以对施加到所述旋钮的力的大小提供测量。指示标记(显示在图A中)以被呈现在螺纹旋钮240的远端壁249的外部,从而指示在转动所述旋钮时力的大小。通过沿着任意方向转动旋钮246而对其进行调节,从而增大或减小拉力,直到拉力达到最佳水平。
[0066]参考图38,显示了穿过远端筒夹组件132的缆索116的局部剖视图,远端筒夹组件132由插入引导件166和固定装置102的近端端部体节110之间的连接所环绕。为了清楚,缆索未以剖面显示,而是显示了缆索的程式化的外表面。在插入引导件166上的外连接螺纹262与固定装置102上的内连接螺纹264接合,从而将插入引导件166相对于固定装置102保持在固定位置。缆索筒夹锚固件272配合在固定装置的近端端部内,并延伸较短距离而进入到插入引导件166内。缆索筒夹锚固件272可以整体形成在所述固定装置中,或者可以压配合或另外的连接所述固定装置。具有锥形壁276的腔室274位于缆索筒夹锚固件272的远端端部中,并且缆索筒夹锚固件的近端端部具有内筒夹螺纹278。
[0067]缆索筒夹螺钉280配合在缆索筒夹锚固件272内,并通过与内筒夹螺纹278接合的外筒夹螺纹282而支撑到位。在缆索筒夹螺钉的近端端部处,成形的内壁286环绕缆索孔202。多个挠性指状部284向远端延伸进入到腔室274内。缆索筒夹螺钉280和缆索筒夹锚固件272一起形成锁定机构。
[0068]筒夹驱动件250的驱动件轴252经过插入引导件166而向远端延伸。如图B所示,筒夹驱动件250被接收在拉紧件内,但是独立于所述拉紧件而操作。驱动件轴252的工作端部254的形状为与缆索筒夹螺钉280的成形的内壁286配合。工作端部254的形状可以为六边形或者构造为与所述缆索筒夹螺钉配合的其它形状。
[0069]在缆索被如上所述地拉紧后,筒夹驱动件250被调节,从而调节包括缆索筒夹螺钉280和锚固件272的锁定机构。为了相对于固定装置102在第三位置处锁定拉紧的缆索的位置,要将缆索筒夹螺钉280拧紧。为了拧紧缆索筒夹螺钉280,要转动筒夹驱动件250,从而转动筒夹驱动件轴252。工作端部254与缆索筒夹螺钉的成形的内壁286配合,并由此转动缆索筒夹螺钉280。当筒夹螺钉280转动并在锚固件272内前进时,指状部284前进到腔室274内。当筒夹指状部284向锥形壁276偏压时,指状部284被推进到一起,从而夹持缆索116并相对于固定装置102锁定其位置。在此位置,可防止沿任何方向拉动缆索116。然而,通过简单地将筒夹螺钉280从锚固件272内拧松,从而指状部284能够自由地向外弯曲,缆索116又能够自由地移动。
[0070]一旦缆索116被锁定在缆索筒夹螺钉280中,缆索上相对于固定装置102的拉力就被固定。近端筒夹210可以被拧松,从而松开其缆索116上的夹持。外壳230可以从插入引导件166离开,从而使拉紧件工具200从插入引导件166移走。所述插入引导件可以随后被拧松并从固定装置102被移走,从而留下被锁定在缆索筒夹螺钉280中的缆索116。可替代地,外壳230可以保持停靠在插入引导件166内,并且插入引导件166可以从固定装置102松开,从而将停靠的拉紧件工具200与其一起取走。在插入引导件和拉紧件工具都被移走后,从远端筒夹螺钉280向近端延伸的缆索116可以被切除为最佳长度。
[0071]因而,如上所述,已经提出了改进的髓内结构。虽然该结构已经以某些具体的实施方式被描述,但是并不旨在将本发明限制为这些实施方式。代替地,本发明由所附的权利要求书来限定。

Claims (26)

1、一种适于被容放在长骨的髓腔中的可植入髓内固定结构,包括:
多个长型体节,每个体节具有第一端部和形状互补的第二端部,从而体节的所述第一端部和相邻体节的所述第二端部协调地接合,所述体节限定引导孔隙,从而能够容放在用于在髓腔中定位的引导件上。
2、根据权利要求1所述的髓内结构,进一步包括拉紧构件,所述拉紧构件沿着其长度延伸,以沿着所述结构的纵向轴线施加压缩力。
3、根据权利要求1所述的髓内结构,进一步包括至少一个紧固件,所述紧固件容放在至少一个体节中,用于在所述长骨中将所述结构固定到位。
4、根据权利要求1所述的髓内结构,进一步包括可硬化的外科流体,用于在所述长骨中将所述结构固定到位。
5、根据权利要求1所述的髓内结构,其中所述长型体节的形状互补的端部允许相邻体节之间基本仅轴向地并且在单个平面中的相对运动。
6、根据权利要求5所述的髓内结构,其中所述形状互补的端部包括四个表面,第一和第二表面为基本平坦,并且为基本平行的平面,第三表面基本平坦,并且为基本垂直于所述第一和第二表面的平面,第四表面限定基本垂直于所述第一和第二表面并倾斜于所述第三表面的平面。
7、根据权利要求6所述的髓内结构,其中所述长型体节的第四表面包括多个台阶。
8、根据权利要求1所述的髓内结构,其中相邻的长型体节彼此固定。
9、根据权利要求8所述的髓内结构,其中通过安装到一个体节并容放在长槽和相邻体节中的铰接销,而使相邻的长型体节彼此固定。
10、根据权利要求1所述的髓内结构,进一步包括径向可扩张的构件,所述径向可扩张的构件容放在最远端体节的远端;并具有固定到所述径向可扩张的构件的缆索,所述缆索安放在所述导向孔隙中,并经过所述髓内结构而延伸。
11、根据权利要求10所述的髓内结构,其中所述可扩张的构件包括扩张件,所述扩张件具有多个下垂支脚以及楔,所述缆索固定到所述楔,从而当拉紧所述缆索时,所述楔使所述扩张件的所述支脚沿径向向外展开。
12、一种用于拉紧外科缆索的组件,所述组件包括:
缆索,所述缆索具有能够连接到植入件的第一位置;
锁定部件,所述锁定部件构造为沿周向与所述缆索接合,从而锁定到所述缆索上的第二位置上;
拉紧件,所述拉紧件构造为与所述锁定部件接合,其中所述拉紧件能够被调节,以相对于所述第一位置移动所述锁定部件,从而当所述第一位置被连接到所述植入件,并且所述第二位置被锁定在所述锁定部件中时,调整在所述第一位置和所述第二位置之间的所述缆索上的拉力;以及
锁定机构调节器,所述锁定机构调节器构造为调节锁定机构,从而将所述锁定机构锁定到所述缆索上的第三位置。
13、根据权利要求12所述的组件,其中所述植入件为分节髓内骨折固定装置。
14、根据权利要求12所述的组件,其中所述第三位置位于所述第一位置和所述第二位置之间。
15、一种用于拉紧外科缆索的组件,所述组件包括:
缆索,所述缆索具有能够连接到植入件的第一位置;
锁定部件,所述锁定部件构造为与所述缆索接合,从而锁定到所述缆索上的第二位置上;
拉紧件,所述拉紧件构造为与所述锁定部件连接,其中所述拉紧件能够被调节,以相对于所述第一位置移动所述锁定部件,从而当所述第一位置被连接到所述植入件,并且所述第二位置被锁定在所述锁定部件中时,调整在所述第一位置和所述第二位置之间的所述缆索上的拉力;以及
锁定机构调节器,所述锁定机构调节器构造为可逆地调节锁定机构,从而将所述锁定机构锁定到所述缆索上的第三位置,并从第三所述第三位置解除锁定,其中所述锁定机构调节器被存放在所述拉紧件内。
16、根据权利要求15所述的组件,其中所述植入件为分节髓内骨折固定装置。
17、根据权利要求15所述的组件,其中所述第三位置位于所述第一位置和所述第二位置之间。
18、根据权利要求15所述的组件,其中所述锁定部件构造为沿周向与所述缆索接合。
19、一种用于拉紧外科缆索的方法,所述方法包括:
将缆索上的第一位置连接到植入件;
将锁定部件锁定到所述缆索上的第二位置上,其中所述锁定部件沿周向与所述缆索接合,从而锁定到所述缆索上;
调节拉紧件,从而调整在所述第一位置和所述第二位置之间的所述缆索上的拉力;并且
将锁定机构锁定到所述缆索上的第三位置上。
20、根据权利要求19所述的方法,其中所述植入件为分节髓内骨折固定装置。
21、根据权利要求19所述的方法,其中所述第三位置位于所述第一位置和所述第二位置之间。
22、根据权利要求19所述的方法,进一步包括在调整所述缆索上的拉力之后,调节所述锁定机构调节器,从而将所述锁定机构锁定到所述缆索上的所述第三位置。
23、一种用于拉紧外科缆索的方法,所述方法包括:
将缆索上的第一位置连接到植入件;
将锁定部件锁定到所述缆索上的第二位置上,其中所述锁定部件沿周向与所述缆索接合,从而锁定到所述缆索上;
调节拉紧件,从而调整在所述第一位置和所述第二位置之间的所述缆索上的拉力;并且
将锁定机构锁定到所述缆索上的第三位置上。
24、根据权利要求23所述的方法,其中所述植入件为分节髓内骨折固定装置。
25、根据权利要求23所述的方法,其中所述第三位置位于所述第一位置和所述第二位置之间。
26、根据权利要求23所述的方法,进一步包括在调整所述缆索上的拉力之后,调节所述锁定机构调节器,从而将所述锁定机构锁定到所述缆索上的所述第三位置。
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US20090228008A1 (en) 2009-09-10
US20130006245A1 (en) 2013-01-03
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US8128627B2 (en) 2012-03-06
CA2678911A1 (en) 2008-09-25
US8430879B2 (en) 2013-04-30
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US20090228007A1 (en) 2009-09-10
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