CN1753651A - 关节植入件系统 - Google Patents

关节植入件系统 Download PDF

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Publication number
CN1753651A
CN1753651A CNA2004800036898A CN200480003689A CN1753651A CN 1753651 A CN1753651 A CN 1753651A CN A2004800036898 A CNA2004800036898 A CN A2004800036898A CN 200480003689 A CN200480003689 A CN 200480003689A CN 1753651 A CN1753651 A CN 1753651A
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China
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distal
extension
rod member
implantation piece
ulna
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CNA2004800036898A
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CN100488470C (zh
Inventor
肖恩·汉森
格雷厄姆·J·W·M·D·金
斯图尔特·D·M·D·帕特森
艾伦·泰勒
詹姆斯·A·约翰逊
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Wright Medical Technology Inc
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Wright Medical Technology Inc
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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
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4261—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for wrists
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
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    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4606—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof of wrists or ankles; of hands, e.g. fingers; of feet, e.g. toes
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    • 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
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    • 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
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    • 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
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    • 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
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    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
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    • 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
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    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30574—Special structural features of bone or joint prostheses not otherwise provided for with an integral complete or partial collar or flange
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • 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
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0065—Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
  • Paper (AREA)

Abstract

提供了一种用于固定到骨头上的关节植入件系统。该关节植入件系统包括：固定元件，其用于固定到骨头上；关节元件，其用于与骨头或软骨接合。具体地，根据本发明的关节植入件系统提供了一种组合式尺骨植入件，其中所述固定元件为用于插入到远端尺骨的髓腔中的杆件，而关节元件是用于与桡骨的S形凹窝接合的头部件。

Description

关节植入件系统
技术领域
本发明涉及一种用于固定到骨头上的关节植入件系统。具体地，本发明提供了一种用于置换远端尺骨的关节植入件系统。
背景技术
桡尺近侧关节和桡尺远侧关节都是滑膜关节。近侧关节位于桡骨头部和尺骨的桡骨切迹之间。桡尺远侧关节通过关节盘与腕部分离，该关节盘从尺骨茎突的基部延伸至桡骨。
桡尺远侧关节是形成在尺骨头部和桡骨下端上的尺骨切迹之间的枢轴关节。关节表面通过掌侧桡尺韧带、背侧桡尺韧带和关节盘而连接在一起。掌侧桡尺韧带是一从桡骨的尺骨切迹的前边缘延伸至尺骨头部前端的狭窄的纤维带。背侧桡尺韧带在关节背面上的相应表面之间延伸。关节盘为三角形的形状，并且在尺骨头部下方横向布置，并将尺骨和桡骨的下端部牢固地结合在一起。关节盘的周边比其中部厚，这有时会穿孔。关节盘通过其顶部安装在茎突和尺骨头部之间的凹窝中；通过其较薄的基部安装在桡骨的突出边缘上，该边缘使尺骨切迹与腕关节面分离。关节盘的边缘与腕关节的韧带相结合。其光滑且凹入的上表面与尺骨头部接合，从而形成摩动关节；其同样光滑且凹入的下表面形成腕关节的一部分，并且与月骨的三角骨和中间部分接合。这两个表面都由滑膜覆盖；所述上表面由桡尺远侧关节的滑膜覆盖，而下表面由腕部的滑膜覆盖。
桡骨以旋前和旋后的方式接合在远端尺骨上。尺骨(与腕部相连的相对较直的前臂骨)朝手掌背侧平移以接收稍微弯曲的桡骨。由于大多数腕部中的S形窝臼相对扁平，因此需要韧带支撑远端尺骨。这些韧带包括三角纤维软骨(TFC)、尺侧伸腕肌(ECU)半鞘(subsheath)和尺侧副韧带复合体。已经很好地识别出三角纤维软骨(TFC)、尺侧伸腕肌(ECU)半鞘和尺侧副韧带复合体的稳定成分，以及充分认识到远端尺骨组件(尺骨头部)对于将尺骨囊和远端尺骨之间的压缩载荷转移通过桡尺远侧关节的重要性。桡尺远侧关节分担随着前臂转动和紧握而产生的负荷力。旋前和旋后的弧度平均为150至160度，且最有用的部分在80度旋前和45度旋后之间。
人类中最常见的骨折之一就是远端桡骨骨折。固有的骨质不稳定、软组织损坏、以及频繁的并发损伤使得远端桡骨骨折非常难于治疗。远端桡骨骨折通常由跌倒时伸出手支撑而引起。当人们跌倒时伸出手支撑时，手突然变得僵硬，并且跌落的冲量将致使在前臂上既作用扭曲力又作用压缩力。这些力可能引起的伤害类型取决于受伤者的年龄。对于儿童、老年人，这种跌倒可能导致桡骨骨折。直接的损伤也可能导致远端桡骨骨折，例如在车祸中就可能发生这种骨折。
有几种类型的骨折。非移位性骨折是其中骨破裂而碎片保持对齐的骨折。隆起或卷起骨折使桡骨的后部弯曲而离开生长板。移位性骨折是其中骨断裂成不对齐的两片或多片的骨折。这些断裂可能非常疼痛，并且产生易于看出的畸形。开放性或复合性骨折是其中骨的端部移位并且刺穿皮肤的骨折。在这些情况下，都有极大的感染危险。
对于移位的断骨，为了适当地治疗并且没有严重的并发症，需要将它们固定并且保持在身体适当的位置处，以修复并替换损伤的骨。该过程通常需要4至12周。一些骨折可不用外科手术固定，首先通过夹板将骨保持在适当的位置，然后在开始康复之后通过石膏模型固定。然而，如果骨严重移位，或如果有需要修复的损伤，则可能需要外科手术，并且可能需要针或线将骨保持在一起。
闭合治疗方法包括造模、针和石膏，而外部固定通常得不到满意的结果。使用外部切开复位的治疗和通过传统板系统的内部固定已经产生了一些有希望的结果，此时也获得了组织复位和早期可动。受伤关节的立即可动值是零。
对于远端桡骨骨折，在骨康复期间肌肉可能由于缺乏使用而逐渐衰弱。患者可能需要物理治疗，以恢复对腕部的正常使用。
远端桡骨以及前臂其它转动不稳定性损伤的骨折通常随后产生韧带断裂、尺骨茎突骨折以及桡尺远侧关节骨折。与桡尺远侧关节有关的骨折或脱臼经常导致在远端桡骨的S形凹窝和尺骨头之间的、与不稳定性或不协调性相关的前臂转动的丧失。与远端桡骨有关的不同种类的骨折可导致包括科勒斯氏骨折和加莱阿齐骨折的这种情况。
当桡尺远侧关节的稳定性丧失时，随后就会发生紧握和拧捏变弱以及前臂转动可能丧失。不稳定性还可能与三角纤维软骨或尺骨茎突的损伤并发。当出现不稳定性时，已经发明了许多韧带重建疗法以辅助治疗不稳定的远端尺骨。遗憾的是，远端尺骨的韧带重建在恢复稳定性中经常是不完善的，并且经常需要更换关节。
在存在与尺骨头与远端桡骨的S形凹窝的接合有关的关节表面的不协调性的情况下，或者如果在尺骨头的远侧关节表面和尺骨囊之间有显著的尺骨撞击综合征，则必须更换关节。具体地，这可能包括远端尺骨的关节置换或手术过程，以旨在缩短尺骨或者切除全部或部分远端尺骨(即，尺骨头切除术(Darrach resection procedure)、鲍尔斯切除术(Bowers resection procedure)或匹配切除术(matched resectionprocedure))。
使用植入件或假体来修复患者损伤的上和下肢骨，例如手指、腕、肘、膝和踝。这些假体在例如由病理条件(例如，类风湿性关节炎、变性关节炎，无菌性坏死)所致损伤的关节重建中尤其有用，并且用于治疗可能使关节衰弱的外伤。
有三种类型的关节成形术：1)非限制的；2)半限制的；以及3)完全限制的。当前这些关节置换设计的共同缺点是无法对置换的关节的重要原生囊束缚和韧带束缚进行重建和再次相连，这些在很大程度上影响关节的性能和稳定性(即，关节的运动)。
腕部置换手术的主要目的是缓解疼痛并且保持腕和手的功能。因此，用于通过假体置换桡尺远侧关节(仅置换尺骨头部)的重建的主要适应症，通常涉及远端尺骨的骨折或延伸至桡尺远侧关节的、产生创伤后关节炎的骨折。由于其它原因导致的变性关节炎也是主要的适应症。如果存在并发关节炎或尺骨缩短术是不可取的，则考虑该疗法。作为最通常形式关节炎的骨关节炎由覆盖在骨上的软骨的磨损引起。用于基本尺骨置换的第三种情况是伴有疼痛和不稳定的桡尺远侧关节的类风湿性关节炎。类风湿性关节炎是关节的慢性炎症疾病，它可导致疼痛、僵硬和肿胀。类风湿性关节炎通常累及身体左右两侧的多个关节。两种形式的关节炎都可影响手指和手的强度，使其难以夹持或拧捏。在某些情况下，将腕骨融合在一起会减轻或消除疼痛并且提高夹持强度。然而，如果将骨融合在一起，则丧失了腕部运动和弯曲的能力。腕部置换手术可保持或恢复腕部的运动。在这些情况下，通过软组织徙前的远端尺骨修复置换可能是有利的。
远端尺骨假体也适于对先前失败的远端尺骨切除进行矫正。这种修复可用于关节接合表面部分切除和远端尺骨完全切除的情况。当面临失败的远端尺骨切除时，一个选择是在不恢复桡尺远侧关节(DRUJ)的情况下以重建为目标。例如，可通过旋前方肌插入来矫正失败的远端尺骨，或者如果仅有局部切除，则将桡尺远侧关节与近侧假关节融合在一起(尺骨假关节成形术，Suave-Kapandji术)。然而，这些方法并没有恢复正常DRUJ的运动或转移载荷的功能，并且可能并发远端尺骨的不稳定性和远端桡骨上的尺骨近侧冲击。在这些情况下，通常优选远端尺骨假体。远端尺骨假体也适于对先前失败的假体置换，例如硅酮尺骨头置换进行矫正。
希望有可附着于软组织囊(包括三角纤维软骨、尺侧伸腕肌(ECU)半鞘和尺侧副韧带复合体)的远端尺骨假体，以保持桡尺远侧关节的稳定性，所述远端尺骨假体与远端桡骨的S形凹窝在解剖学上对齐，并且与前臂的解剖转动中心等对称，并允许约150至170度的正常前臂转动。更具体地，希望有这样的组合式远端尺骨假体，其中，没有由于来自通过缝合附着在植入件上的组织的生物机械力而引起两个元件(杆件和头部件)分离的危险。
发明内容
本发明涉及一种用于固定到骨头上的关节植入件系统。该植入件系统包括两个元件：固定元件和关节元件。
该固定元件具有第一端部和第二端部。固定元件的第一端部构造成用于固定到骨头上。该固定元件可以例如为一杆件。固定元件的第二端部构造成用于与关节元件操作连接。缝合连接装置设置在固定元件的第二端部处或其附近。该缝合连接装置可以是例如设置用于接收缝合线的孔，这些孔被定位成通过设置在固定元件的第二端部处的延伸部。
该关节元件构造成用于接合骨头或软骨。可选择的是，该关节元件的一部分可具有用于向内生长的多孔表面。该部分优选位于固定元件的缝合连接装置的附近。连接锥装置可设置在其第一端部处。关节元件构造成用于与固定元件操作连接。这可以通过例如莫氏锥(Morse taper)来完成。优选的是，固定元件的缝合连接装置与关节元件配合，从而使连接装置设置在关节表面附近的适当位置处。
在一个实施方案中，在固定元件的第二端部处设有延伸部。缝合孔设置在该延伸部的远端和近端处。贯穿关节元件设置一洞，从而固定元件的延伸部从其中穿过，设置在延伸部的远端处的缝合孔延伸穿过该洞，设置在延伸部的近端处的缝合孔不穿过该洞。因此，组装后，该植入件系统在关节元件的两端都具有连接装置。
本发明的关节植入件系统尤其适于远端尺骨切除后的组合式尺骨植入件。在组合式尺骨植入件的实施方案中，该固定元件为一杆件，而关节元件为一头部件。通常，该组合式尺骨植入件包括一偏心头部件和一杆件，该杆件具有用于接收缝合线的缝合孔，以将植入件锚定在远端尺骨切除后暴露的软组织上。优选地，该杆件通过莫氏锥安装在该头部件上。这些软组织包括尺侧囊、三角纤维软骨和尺侧伸腕肌半鞘。
头部件从杆件偏移，且成三角形，以模拟正常的解剖组织，并且具有用于与桡骨的S形凹窝配合的大约200°的弧形部。该头部件包括完全贯穿延伸的洞，用于接收杆件的延伸部。此外，该头部件可在其远端表面上包括排放孔和器械接触面，以允许进行有效的体内组装和转动定位。可选择的是，该头部件至少在成三角形部分附近用向内生长覆层覆盖，以促进软组织的向内生长。
该杆件具有第一端部和第二端部。杆件的第一端部构造成用于固定到骨头上，且为锥形以与尺骨腔解剖组织接合，并且优选地在该腔上开槽，以有效地固定。杆件的第二端部构造成与头部件操作连接。该杆件在杆件的第二端部处头部接触面的附近包括一平台部，以防止沉降到尺骨腔中。该杆件包括用于接收缝合线的缝合孔，以将植入件锚定到软组织上。这些缝合孔将植入件锚定到三角形软骨组织中。可使用杆件延伸凸缘以增加额外的切除高度。该杆件可包括用于定位控制的器械接触面。
在一个实施方案中，该杆件在第二端部处包括一延伸部，该延伸部优选地位于莫氏锥的中央。该延伸部构造成由头部件中的洞接收。在该延伸部的远端处设置有至少一个用于接收缝合线的缝合孔，该缝合孔在将头部件放置在杆件上之后可接近。也可将这些缝合孔在头部件接触面附近设置在杆件的第二端部附近的平台部上。在该实施方案中，在平台部和延伸部中的缝合孔将植入件锚定在三角形软组织上。
该关节植入件系统允许在关节元件表面或位置附近连接组织，而不用将缝合线连接在元件上。这允许在组合式尺骨植入件系统中的关节元件、头部件相对于组织缝合连接部单独转动和定位。组织连接部的力或限制并不影响关节元件的定位或行为。该植入件通过不限制于关节元件的非接合区域而允许更多种形式的缝合连接。
在典型的尺骨植入件的情况下，存在由于植入件相对于周围组织的转动而引起元件分离的危险，该组织可以是缝合附着于植入件的组织。采用本发明的设计，消除了元件分离的危险。使用本发明的组合式尺骨植入件，不存在两个元件(杆件和头部件)由于通过缝合而附着于植入件的组织的生物机械力引起的分离的危险。通过将缝合连接装置设置在固定元件(在组合式尺骨植入件系统中的杆件)上，来自缝合组织连接部的力直接通过固定元件(而不通过关节元件与固定元件的连接)传递到骨头上。
附图说明
图1显示根据本发明的组合式尺骨植入件的一个实施方案；
图2显示图1的组合式尺骨植入件的杆件；
图3显示图1的组合式尺骨植入件的头部件。
具体实施方式
本发明涉及一种用于固定到骨头上的关节植入件系统。该植入件系统包括两个元件：固定元件和关节元件。
图1显示根据本发明的关节植入件系统的组合式尺骨植入件10。该植入件10旨在用于远端尺骨在其切除后的解剖上的置换。组合式尺骨植入件10包括固定元件和关节元件。具体地，固定元件为杆件12，而关节元件为头部件14。优选地，杆件12通过莫氏锥与头部件14相连。
具体参考图1，杆件12或固定元件是细长的且形成有第一端部16和第二端部18。杆件的第一端部16构造成用于固定到骨头上，具体地，用于插入到远端尺骨的髓腔中，从而将组合式尺骨植入件锚定在远端尺骨上。杆件12为锥形，以匹配尺骨腔解剖组织并且有利于杆件的第一端部16插入到远端尺骨的髓腔中。优选地，杆件12设有沟槽20，用于防止杆件12在远端尺骨的髓腔中转动，从而便于在腔内有效地固定植入件10。杆件的第二端部18可形成有粗糙或多孔表面，以在杆件和远端尺骨之间实现无粘固剂连结。或者，除了这种表面之外，可以使用粘固剂将杆件12锚定在远端尺骨的髓腔中。
杆件的第二端部18构造成用于与头部件14操作连接。杆件12在杆件的第二端部18处头部接触面附近包括平台部22，以防止杆件12沉降到尺骨腔中或杆件12过多地穿入远端尺骨的髓腔内。
杆件12在杆件的第二端部18处或附近包括用于接收缝合线的缝合孔24和26，以将植入件10锚定在软组织上。穿过缝合孔24和26的缝合线将植入件锚定在远端尺骨切除后暴露的三角形软组织上。这些软组织包括尺侧囊、三角纤维软骨以及尺侧伸腕肌半鞘。可使用杆件延伸凸缘以增加额外的切除高度。杆件12可包括用于定位控制的器械接触面。
如图2清晰所示，杆件12在其第二端部18处包括延伸部28，该延伸部优选定位在中心，并且形成为莫氏锥。延伸部28构造成用于被头部件14中的洞接收。在延伸部28的远端30处设置至少一个用于接收缝合线的缝合孔24，该缝合孔24在将头部件14放置在杆件12上之后可接近。缝合孔26也可在头部接触面附近设置在杆件的第二端部18附近的平台部22上。在该实施方案中，分别在平台部和延伸部中的缝合孔26和24，将植入件10锚定在三角形软组织中。
如图3所示，头部件14或关节元件构造成与骨头或软骨接合。参照图1，可以看出头部件14在组装完植入件10之后从杆件12偏移。头部件14为三角形以模拟正常的解剖组织，并且具有用于与桡骨的S形凹窝配合的大约200°的弧形部。该头部件包括完全贯穿延伸的洞32，用于接收杆件的延伸部。在可替换实施方案中，头部件14可包括不完全贯穿其中的洞，用于与杆件12的第二端部18配合。此外，头部件14在其远端表面可包括排放孔和器械接触面，以允许进行有效的体内组装和转动定位。可选择的是，头部件14至少在三角形部分附近用向内生长覆层覆盖，或者设置有多孔表面，以促进软组织的向内生长。
杆件12的第二端部18和头部件14的洞32互补配合，从而当杆件的第二端部18插入到头部件14的洞32中时在头部件14和杆件12之间提供牢固的装配。因此，例如，洞32被设置穿过头部件14从而杆件12的延伸部28完全穿过其中，且杆件12的延伸部28和洞32为莫氏锥。在图1所示的实施方案中，通过洞32插入杆延伸部28，这使得设置在延伸部28的远端30处的缝合孔24延伸穿过洞32，而设置在延伸部的近端34处的缝合孔26不穿过洞32。因此，组装后，植入件10在头部件14的两端都具有缝合孔。
因此，使用本发明的组合式尺骨植入件，通过杆件(或固定元件)将植入件安装在软组织上。通过将缝合连接装置设置在固定元件(即，组合式尺骨植入件系统中的杆件)上，将来自缝合组织连接的力直接通过固定元件(而不通过关节元件与固定元件的连接)传递到骨头上。结果，不存在由于通过缝合附着于植入件的组织的生物机械力而引起头部件和杆件分离的危险。
为了植入根据本发明的关节植入件系统的尺骨植入件，首先使远端尺骨暴露。可通过与尺骨茎突成直线沿着远端尺骨的中轴线切开而将远端尺骨暴露。或者，可使用与第四掌骨成直线在桡尺远侧关节中心的背切而将远端尺骨暴露。一旦暴露，则将模板靠着远端尺骨放置且在远端尺骨的关节表面上定位在远侧，以标记指定的切除长度。通过使用例如摆锯切除远端尺骨，从而暴露髓腔和先前围绕远端尺骨的软组织。一旦暴露，则确定髓腔且扩孔，以容纳适当尺寸的杆件。
在植入尺骨植入件之前，可使用试验杆件和试验头部件来检验解剖上的对准，并且确保已经获得适当的切除长度。在移除试验杆件和试验头部件之后，可以将植入件的杆件插入到远端尺骨的髓腔中，从而将植入件锚定到远端尺骨上。具体地，通过使用例如压紧器将杆件的第一端部插入到髓腔中，直到平台部接触远端尺骨。可通过在杆件上施加远端牵引来评估在杆件和远端尺骨之间的装配。杆件在远端尺骨的髓腔中的任何运动都说明尚未获得牢固的装配。如果在压紧杆件之后未获得杆件和远端尺骨之间牢固的装配，则可使用骨粘固剂(例如，聚甲基丙烯酸甲酯)将杆件固定在远端尺骨上。
一旦杆件被固定在远端尺骨中，则可将头部件压紧在杆件上。具体地，可将在杆件的第二端部处的延伸部插入到形成在头部件中的洞中。可以通过压紧器使头部件在杆件上前进，直到在头部件和杆件之间获得牢固的装配。
然后，可使用形成在杆件中的缝合孔将杆件缝合到先前围绕远端尺骨的软组织(具体地，尺侧囊、三角纤维软骨和尺侧伸腕肌半鞘)上。可使用不可吸收性缝合线。通过使缝合线通过固定元件而连接在植入件上，使来自缝合组织连接部的力直接通过固定元件传递到骨头上，从而减少或者消除由于这些力而使元件分离的危险。在将头部件连接到杆件上并且将杆件缝合到软组织上之后，可将缝合线打结在植入件周围的囊套内，并且可将皮下组织和皮肤封闭在植入件上。
尽管已经公开了本发明的优选实施方案，但是应理解，在不脱离本发明的精神和所附权利要求的范围的情况下，可在这里进行各种变化、改变和修改。
相关申请
本申请要求于2003年2月5日提交的美国临时专利申请No.60/445,474的优先权。

Claims (20)

1、一种尺骨植入件，用于在远端尺骨切除后置换该远端尺骨，其中，该切除使得先前与远端尺骨接触的软组织暴露，该植入件包括：
细长的杆件，其具有第一端部和第二端部，该第一端部按尺寸制成并构造成用于插入到远端尺骨的髓腔中，该第二端部构造成与头部件连接，其中在该第二端部处或其附近设有用于接收缝合线的缝合孔，该缝合线用于连接该植入件和软组织；
头部件，其具有三角形结构，以充分模拟正常的解剖组织，该头部件构造成用于与远端桡骨的S形凹窝配合，并且该头部件还构造成用于与所述杆件的第二端部连接。
2、根据权利要求1所述的植入件，其特征在于，在所述杆件的第二端部处或其附近还包括一平台部，该平台部构造成用于防止沉降到远端尺骨中。
3、根据权利要求1所述的植入件，其特征在于，所述缝合孔设置成穿过所述平台部。
4、根据权利要求1所述的植入件，其特征在于，还包括从所述杆件的第二端部延伸的延伸部，该延伸部具有近端和远端，所述缝合孔设置在该延伸部的近端和远端处。
5、根据权利要求4所述的植入件，其特征在于，所述头部件包括完全贯穿延伸的洞以接收所述杆件的延伸部，所述杆件的该延伸部构造成这样，即，该延伸部的近端完全延伸穿过该洞。
6、根据权利要求5所述的植入件，其特征在于，所述延伸部和洞为莫氏锥。
7、根据权利要求4所述的植入件，其特征在于，还包括构造成用于防止沉降到尺骨腔中的平台部，该平台部定位在所述延伸部处或其附近。
8、根据权利要求7所述的植入件，其特征在于，所述缝合孔设置成穿过所述平台部和所述延伸部的近端。
9、根据权利要求1所述的植入件，其特征在于，所述头部件包括用于与所述桡骨的S形凹窝配合的200度的弧形部。
10、根据权利要求1所述的植入件，其特征在于，所述头部件的至少一部分用向内生长覆层覆盖，从而促进软组织的向内生长。
11、根据权利要求1所述的植入件，其特征在于，所述杆件在其第一端部处包括沟槽，以防止所述杆件在远端尺骨的髓腔中转动。
12、一种尺骨植入件，用于在远端尺骨切除后置换该远端尺骨，其中，该切除使得先前与远端尺骨接触的软组织暴露，该植入件包括：
细长的杆件，其具有第一端部和第二端部，该第一端部按尺寸制成并构造成用于插入到远端尺骨的髓腔中，该第二端部构造成用于与头部件连接，其中在该第二端部处或其附近设有用于接收缝合线的缝合孔，该缝合线用于连接该植入件和软组织；
延伸部，其从所述杆件的第二端部延伸，该延伸部具有近端部分和远端部分以及端部，且缝合孔设置在该延伸部的近端部分中；
平台部，其构造成用于防止杆件沉降到尺骨腔中，该平台部定位在所述延伸部的远端处或其附近，其中缝合孔设置成穿过该平台部；以及
头部件，其为三角形结构以模拟正常的解剖组织，该头部件构造成与远端桡骨的S形凹窝配合，并且该头部件包括完全贯穿延伸的洞，用于接收所述杆件的延伸部，所述杆件的延伸部构造成这样，即，该延伸部的近端完全延伸穿过所述洞。
13、根据权利要求12所述的植入件，其特征在于，所述头部件包括用于与桡骨的S形凹窝配合的200度的弧形部。
14、根据权利要求12所述的植入件，其特征在于，所述头部件的至少一部分用向内生长覆层覆盖，从而促进软组织的向内生长。
15、根据权利要求12所述的植入件，其特征在于，所述杆件在其第一端部处包括沟槽，从而防止该杆件在远端尺骨的髓腔中转动。
16、一种用于将组合式尺骨植入件植入到患者中的方法，该方法包括如下步骤：
暴露并且切除患者的远端尺骨，以暴露尺骨的髓腔和先前围绕远端尺骨的软组织；
提供具有第一端部和第二端部的细长的杆件，该第一端部按尺寸制成并构造成用于插入到远端尺骨的髓腔中，该第二端部构造成用于与头部件连接，其中用于接收缝合线的缝合孔设置在该第二端部处或其附近，该缝合线用于连接植入件和软组织；
提供一头部件，该头部件构造成与远端桡骨的S形凹窝配合，并且该头部件进一步被构造成用于与杆件的第二端部连接；
将所述杆件插入到远端尺骨的髓腔中；
将所述杆件缝合到先前围绕远端尺骨的软组织上；以及
将所述头部件安装到杆件上。
17、根据权利要求16所述的方法，其特征在于，使用不可吸收性缝合线，以将所述杆件缝合到先前围绕远端尺骨的软组织上。
18、根据权利要求16所述的方法，其特征在于，所述杆件被缝合到尺侧囊上。
19、根据权利要求16所述的方法，其特征在于，所述杆件被缝合到三角纤维软骨上。
20、根据权利要求16所述的方法，其特征在于，所述杆件被缝合到尺侧伸腕肌半鞘上。
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CA2513917A1 (en) 2004-08-26
BRPI0406686B1 (pt) 2015-02-18
WO2004071357A2 (en) 2004-08-26
DE602004013281T2 (de) 2009-03-05
CA2513917C (en) 2010-05-04
EP1596769B1 (en) 2008-04-23
ATE392869T1 (de) 2008-05-15
BRPI0406686B8 (pt) 2021-06-22
DE602004013281D1 (de) 2008-06-05
CN100488470C (zh) 2009-05-20
KR20050101194A (ko) 2005-10-20
JP4465350B2 (ja) 2010-05-19
AU2004211945B2 (en) 2008-04-24
US20040230312A1 (en) 2004-11-18
AU2004211945A1 (en) 2004-08-26
US7722676B2 (en) 2010-05-25
WO2004071357A3 (en) 2004-11-11
BRPI0406686A (pt) 2005-12-20
US20100234960A1 (en) 2010-09-16
US8512412B2 (en) 2013-08-20
KR100825192B1 (ko) 2008-04-24

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