CN104510519A - 锤状趾植入件及其方法 - Google Patents

锤状趾植入件及其方法 Download PDF

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CN104510519A
CN104510519A CN201410495357.1A CN201410495357A CN104510519A CN 104510519 A CN104510519 A CN 104510519A CN 201410495357 A CN201410495357 A CN 201410495357A CN 104510519 A CN104510519 A CN 104510519A
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bone
implantation piece
surgical device
threaded portion
blade
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丹尼尔·弗朗西斯·麦考密克
杰西卡·劳伦·谢姆韦尔
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7291—Intramedullary pins, nails or other devices for small bones, e.g. in the foot, ankle, hand or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • 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
    • A61F2/4225—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B2017/8655—Pins or screws or threaded wires; nuts therefor with special features for locking in the bone

Abstract

一种植入件，其包括限定第一中心纵轴与凹槽的细长螺纹部分。凹槽限定沿着与第一中心纵轴相同方向延伸的第二中心纵轴。叶片部分从细长螺纹部分延伸出并且具有终止于一点的锥度。

Description

锤状趾植入件及其方法
技术领域
公开的系统与方法涉及植入件。更具体地说，公开的系统和方法涉及安装用于治疗锤状趾的植入件。
背景技术
锤状趾是影响邻近近端趾间(PIP)关节的骨的对准的趾部的畸形。锤状趾可能造成疼痛并且可能导致行走或者穿鞋困难。锤状趾通常可能导致足部上的疮口或伤口。在一些情形中，可能需要外科手术以通过融合近端趾间关节关节与远端趾间(DIP)关节中的一个或两个来矫正畸形。期望改进的植入件与外科手术设备。
发明内容
在一些实施方式中，植入件包括限定第一中心纵轴与凹槽的细长螺纹部分。凹槽限定沿着与第一中心纵轴相同方向延伸的第二中心纵轴。叶片部分从细长螺纹部分延伸出并且具有终止于一点的锥度。
在一些实施方式中，方法包括：形成切口以获得接近第一骨与第二骨之间的关节的机会；使第一骨与第二骨弯曲以便使得第一骨与第二骨相对于彼此成角度布置；以及将外科手术设备插入到第一骨的第一端中直到将外科手术设备的尾端布置在第一骨的第一端附近。在外科手术设备容纳在第一骨内的位置附近的第一骨的第一端中形成狭槽，并且使植入件的螺纹部分前进到第二骨的第一端中。将第一骨重新定位，使得形成在第一骨中的狭槽与从第二骨的第一端延伸出的植入件的叶片部分对直。迫使第一骨与植入件的叶片部分接合，并且使第一外科手术设备跨越关节前进并且与由植入件的螺纹部分限定的凹槽接合。
一种方法，其包括将外科手术设备的前端插入到第一骨的暴露的第一端中直到将外科手术设备的尾端布置在第一骨的第一端附近。植入件的螺纹部分前进到第二骨的暴露的第一端，并且使第一骨重新定位，使得形成在邻近外科手术设备的第一骨中的狭槽与从第二骨的第一端延伸出的植入件的叶片部分对直。第一骨被迫使与植入件的叶片部分接合，并且外科手术设备的尾端跨越第一骨与第二骨之间的关节前进并且进入到由植入件的螺纹部分限定的凹槽中。
附图说明
通过下面对结合附图一起考虑的优选实施方式的详细描述，将会使本发明的这些与其它特征和优点更完全地公开或使得明显，其中相同的附图标记表示相同的部件并且此外其中：
图1是根据一些实施方式的改进锤状趾植入件的一个实例的等距图；
图2是根据一些实施方式在图1中示出的锤状趾植入件的另一个等距图；
图2是根据一些实施方式在图1中示出的锤状趾植入件的侧视图；
图4是根据一些实施方式在图1中示出的锤状趾植入件的端视图；
图5是根据一些实施方式沿着图4中的线5-5所剖切的图1中示出的锤状趾植入件的截面视图；
图6是根据一些实施方式联接到外科手术设备的图1中示出的锤状趾植入件的等距图；
图7是根据一些实施方式联接到外科手术设备的图1中示出的锤状趾植入件的端视图；
图8是根据一些实施方式联接到外科手术设备的图1中示出的锤状趾植入件的沿着图7中线8-8所剖切的横截面视图；
图9示出了根据一些实施方式作出以获取接近至少两个骨之间的关节机会的切口的一个实例。
图10示出了根据一些实施方式用于切除关节的相邻骨的面的切割叶片的一个实例。
图11示出了根据一些实施方式被插入到与拉削或钻取部位相邻的骨中的外科手术设备。
图12示出了根据一些实施方式利用驱动工具驱动到骨中的植入件的一个实例。
图13示出了根据一些实施方式已经插入到邻近其中插入有外科手术设备的骨布置的骨中的根据图1的植入件；
图14示出了根据一些实施方式前进到骨中并且与植入件的一部分接合的外科手术设备；以及
图15示出了根据一些实施方式从骨中及其与植入件的接合移除的外科手术设备。
具体实施方式
优选实施方式的描述旨在结合被认为是全部文字说明的一部分的附图阅来被领会。附图无需按比例绘制，并且出于清楚与简洁的目的本发明的一些特征可能以夸大比例或者略微示意性形式示出。在说明书中，相关术语，诸如“水平”、“竖直”、“向上”、“向下”、“顶部”、“底部”及其衍生词(例如，“水平地”、“向下地”、“向上地”等)应该理解为表示如随后描绘的或者如在讨论中的附图中示出的方向。这些相关术语是为了方便描述并且通常不旨在要求特定的方向。包括“向内地”对“向外地”，“纵向地”对“横向”等的术语被相对于彼此或相对于延伸的轴，或者旋转轴或旋转中心适当地解释。除非另外明确地描述，否则关于附接、接合等的术语，诸如“连接”与“相互连接”，表示一种关系，其中通过介入结构以及可移动或刚性附接件或关系将结构直接或者间接地固定附接到彼此。术语“可操作地连接”是允许相关结构凭借此种关系如所期望的操作这种附接、接合或连接。
有利地，公开的植入件、系统与方法使植入件能够通过小切口安装同时使诸如跖趾关节的关节稳定。此外，植入件能够完全地布置在患者的趾部内，这在安装植入件以治疗关节问题时防止了植入件像传统销钉那样束缚在床单或其它物体上。
图1-图8示出了根据一些实施方式用于治疗锤状趾的改进植入件100的一个实例。如在图1和图2中最佳看到的，植入件100包括在接合部分106处连接在一起的螺纹部分102与叶片部分104。植入件100可以具有基本上线性几何构造，使得由叶片部分104限定的纵轴与由螺纹部分102限定的纵轴对准或共线，并且植入件100具有约19mm(约0.75英寸)的整体长度。然而，在一些实施方式中，叶片部分104相对于由螺纹部分102限定的纵轴成角度布置，使得由叶片部分104限定的纵轴与由螺纹部分102限定的纵轴既不对准也不共线。例如，在一些实施方式中，此角度在0度与45度之间，并且更具体地说，大约在5度与15度之间。2011年4月13日提交的并且通过引用整体包含于此的共同转让的美国专利申请第13/086,136，公开了具有成角度(例如，非线性)构造的植入件的一个实例。本领域中的技术人员将会理解的是，植入件100可以具有其它尺寸并且以不同尺寸设置。例如，植入件100可以提供16mm与22mm的长度，以标识仅几种潜在长度。
螺纹部分102包括沿着其全部长度布置的多个螺纹108。在一些实施方式中，螺纹部分102的长度约为13mm(约0.5英寸)。螺纹部分102逐渐缩减到尖端110以促进螺纹108前进到骨中。在一些实施方式中，螺纹108具有约2mm(约0.08英寸)的最大外径，但是本领域中的技术人员将会理解的是螺纹部分102可以具有其它尺寸并且构造为容纳在人的趾骨内。例如，在一些实施方式中，螺纹108具有约1.6mm与4mm之间的外径，诸如，例如，1.6mm、2.4mm、3.2mm与4.0mm，以标识几种潜在的可能性。
如下面更加详细描述的，螺纹部分102包括凹槽109，凹槽109定尺寸并且构造为将k-线、销、或者其它外科手术设备或仪器容纳在其中。凹槽109在平行于由螺纹部分102限定的纵向长度的方向上沿着螺纹部分102的长度延伸。在一些实施方式中，如在图1和图2中最佳看到的，凹槽109的中心轴布置在由螺纹部分102限定的中心纵轴附近。换句话说，由凹槽109限定的中心轴与由螺纹部分102限定的延伸通过螺纹部分102与叶片部分104的中心的中心轴不共线而是与之平行。在一些实施方式中，凹槽109布置为使得其与螺纹108的小直径相切。尽管未示出，但是在一些实施方式中凹槽109与由螺纹部分102(与叶片部分104)限定的中心轴共线。图6和图7示出了布置在凹槽109内的k-线。在一些实施方式中，诸如图7中示出的实施方式，在k-线10与叶片部分104的侧面128之间设有间隙G，如图4和图8中所示，叶片部分104的侧面128布置为与叶片部分104的侧面130相对。间隙G使骨能够容纳在外科手术设备10与叶片部分106之间。
如在图1中最佳看到的，叶片部分104包括在第一侧面114与第二侧面116上的多个锯齿状边缘112。锯齿状边缘112各自都具有大约等于叶片部分104的厚度的厚度。换句话说，在一些实施方式中，如在图3中最佳看到的，叶片部分104沿着其厚度方向不会逐渐尖细。锯齿状边缘通过图1和图3中示出的谷部或缺口126而彼此分离。如在图1和图2中最佳示出的，叶片部分104可以具有大于其厚度的宽度。例如，叶片部分104可以具有约0.4厘米(约0.16英寸)的宽度与约0.1厘米(约0.04英寸)的厚度，其中每个叶片部分都在叶片部分104的最远端处逐渐尖缩到点118。在一些实施方式中，叶片部分104具有如图4中示出的基本上长方形横截面区域，但是本领域中技术人员将会理解的是叶片部分104可以具有其它横截面几何形状。
如在图1和图2中最佳看到的，接合部分106包括一对从植入件100的相对侧延伸出的突出部120并且具有圆形外边缘122。如图5中示出的，突出部120的侧面124可以基本上彼此平行。突出部在相对于植入件100的纵向方向垂直的方向上远离彼此延伸。
参照图9-图15描述了将植入件100安装在至少两个骨之间的关节中的方法。尽管此方法描述为将植入件安装在近端趾间的关节(PIP)200(即近端趾骨202与中间趾骨304之间的关节)的骨中，但是本领域中的技术人员将会理解的是用于安装植入件100的技术可以应用到诸如例如远端趾间(DIP)关节，即中间趾骨304与远端趾骨206之间的关节208的其它关节。如图9中所示，作出切口以打开PIP关节200。在一些实施方式中，如图10中示出的，具有叶片302的切割工具300用于切除近端趾骨202与中间趾骨204的相邻面。如本领域普通技术人员理解的，可以清创近端趾骨202与中间趾骨204的切除表面。
如图11所示，将k-线、销或者其它适当外科手术设备10插入中间趾骨204并且驱动通过远端趾骨206并且到趾部的端部以外。在一些实施方式中，将中间趾骨204拉削或预钻以形成同样在图11中示出的开口210，并且利用钻、拉削、或者其它适当的外科手术设备(未示出)在近端趾骨202中形成导向孔212。通过拉削形成的孔210定位为距k-线10的距离与到间隙G的距离相应。
将k-线10插入使得尾端10B(图11中未示出)布置在中间趾骨204内或者相对于关节200另外地定位，致使可将植入件100驱动到近端趾骨202中。在一些实施方式中，利用驱动工具将植入件100的螺纹部分102驱动到近端趾骨202中。例如，图12示出了利用驱动工具400，诸如在通过引用的方式整体包含于此的共同转让美国专利申请第13/086,136中公开的驱动工具，驱动到中间趾骨204中的植入件100。本领域中的普通技术人员将会理解的是可以使用其它驱动工具。驱动工具400的轴402可以与钻(未示出)的卡盘接合，以使植入件100的螺纹部分102前进到导向孔212中。将植入件100驱动到骨中直到接合部分抵靠骨。通过以足够的力远离植入件100轴向拉动把手(未示出)使植入件100与驱动工具400分离，从而使O-形环404弯曲并且使驱动工具400与植入件100分离。
图13示出了布置在诸如近端趾骨202的第一骨内的植入件100的螺纹部分102和布置在诸如中间趾骨204的第二骨内外科手术设备10的端部10B。当叶片部分104从中间趾骨202的远端延伸出时叶片部分104被暴露。
中间趾骨204再定位为使得通过拉削中间趾骨204形成孔210与从近端趾骨202的端部延伸出的植入件100的叶片部分104对直。此外，布置在中间趾骨204内的k-线10与由布置在近端趾骨202内的植入件100的叶片部分104限定的凹槽109对直。如图14中所示，中间趾骨204被按压成与叶片部分104接合。叶片部分104的锯齿状边缘112有助于保持中间趾骨204与植入件100的叶片部分104之间的接合。
在一些实施方式中，如图14中所示，k-线10跨越关节200前进到中间趾骨202中并且通过中间趾骨202并且通过植入件100进入跖骨214中。k-线10容纳在凹槽109内，使得植入件100与外科手术设备10接合。初始前端10A(图11和图13)可以是钝化或加盖的以提供图14中示出的暴露的钝端10C。外科手术设备10可以保持在患者内达预定时间期间，例如数分钟、数小时、数天或数月，并且然后如图15中所示地移除以留下植入件100。
因此，在一些实施方式中，外科手术方法包括形成切口以获得接近第一骨与第二骨之间的关节的机会、切除第一骨的第一端与第二骨的第一端中的至少一个、以及使第一骨相对于第二骨弯曲以暴露第一骨的第一端和第二骨的第一端。将第一外科手术设备插入到第一骨中直到到达邻近第一骨的第一端布置的第一外科手术设备的尾端。将第一骨的第一端在与第一外科手术设备布置在第一骨中的位置邻近的位置处进行拉削。在第二骨的第一端中形成导向孔，并且植入件的螺纹部分前进到形成在第二骨中的导向孔中。第一骨再定位为，使得通过拉削形成在第一骨的第一端中的孔与从第二骨的第一端延伸出的植入件的叶片部分对直。第一骨被迫使与植入件的叶片部分接合。第一外科手术设备跨越关节前进到第二骨中，使得第一外科手术设备容纳在由植入件的螺纹部分限定的凹槽内。第一外科手术设备进一步跨越第二关节前进到第三骨中。在一段时间期间以后，将第一外科手术设备从其与植入件和第一骨、第二骨、以及第三骨的接合移除，同时将植入件保持布置在第一骨与第二骨内。
有利地，上述的植入件可以通过如上所述的小的切口安装。此外，在定尺寸并且构造为容纳k-线的植入件中包含凹槽使得能够在关节稳定时安装植入件。
尽管已经根据示例性实施方式描述了公开的植入件、系统和方法，但是它们不限于此。此外，所附权利要求应该广义地理解为包括本系统、植入件和方法的其它变型与实施方式，在不偏离本植入件、系统和方法的范围与等效范围的情况下本领域的技术人员可以做出的本系统、植入件和方法的其它变型与实施方式。

Claims (19)

1.一种植入件，包括：
细长螺纹部分，其限定第一中心纵轴与凹槽，所述凹槽限定沿着与所述第一中心纵轴相同的方向延伸的第二中心纵轴；以及
叶片部分，其从所述细长螺纹部分延伸出，所述叶片部分具有终止于一点的锥度。
2.根据权利要求1所述的植入件，其中，所述叶片部分包括多个锯齿状边缘。
3.根据权利要求1所述的植入件，其中，所述叶片部分沿着其宽度与厚度逐渐缩减到点。
4.根据权利要求1所述的植入件，还包括布置在所述螺纹部分与所述叶片部分之间的接合部分，所述接合部分包括一对突出部，所述一对突出部在垂直于由所述螺纹部分限定的所述第一中心纵轴的方向上沿着相反的方向远离彼此延伸。
5.根据权利要求1所述的植入件，其中，所述第二中心纵轴布置为与所述第一中心纵轴平行但是不共线。
6.根据权利要求5所述的植入件，其中，由所述螺纹部分限定的所述凹槽与所述螺纹部分的螺纹的小直径相切。
7.一种方法，该方法包括：
形成切口以获得接近第一骨与第二骨之间的关节的机会；
使所述第一骨与所述第二骨弯曲，以便使得所述第一骨与所述第二骨相对于彼此成角度布置；
将外科手术设备插入到第一骨的第一端中直到将所述外科手术设备的尾端布置在所述第一骨的所述第一端附近；
在所述外科手术设备容纳在所述第一骨内的位置附近的所述第一骨的所述第一端中形成狭槽；
使植入件的螺纹部分前进到第二骨的第一端中；
将所述第一骨重新定位，使得形成在所述第一骨中的狭槽与从所述第二骨的所述第一端延伸出的所述植入件的叶片部分对直；
迫使所述第一骨与所述植入件的所述叶片部分接合；以及
使所述第一外科手术设备跨越所述关节前进并且与由所述植入件的所述螺纹部分限定的凹槽接合。
8.根据权利要求7所述的方法，还包括将所述外科手术设备从所述第一骨与所述第二骨及其与所述植入件的接合移除。
9.根据权利要求7所述的方法，还包括在插入所述外科手术设备以前切除所述第一骨与所述第二骨中的至少一个。
10.根据权利要求7所述的方法，其中，所述第一骨是足部的近端趾骨或中间趾骨中的一个，并且所述第二骨是足部的所述近端趾骨或所述中间趾骨中的另一个。
11.根据权利要求10所述的方法，其中，所述外科手术设备还跨越第二关节前进并且进入到跖骨中。
12.根据权利要求7所述的方法，其中所述植入件的所述螺纹部分限定与由凹槽限定的第二中心纵轴平行但是不共线布置的第一中心纵轴。
13.根据权利要求7所述的方法，还包括在使所述植入件的所述螺纹部分前进到所述第二骨的所述第一端中以前在所述第二骨的所述第一端中形成导向孔。
14.一种方法，该方法包括：
将外科手术设备的前端插入到第一骨的暴露的第一端中直到所述外科手术设备的尾端布置在所述第一骨的所述第一端附近；
使植入件的螺纹部分前进到第二骨的暴露的第一端中；
使所述第一骨重新定位，使得形成在邻近所述外科手术设备的所述第一骨中的狭槽与从所述第二骨的所述第一端延伸出的所述植入件的叶片部分对直；
迫使所述第一骨与所述植入件的叶片部分接合；以及
使所述外科手术设备的所述尾端跨越所述第一骨与所述第二骨之间的关节前进并且进入到由所述植入件的螺纹部分限定的凹槽中。
15.根据权利要求14所述的方法，还包括：
形成切口以获得接近所述第一骨与所述第二骨之间的所述关节的机会；
使所述第一骨相对于所述第二骨弯曲以暴露所述第一骨的所述第一端与所述第二骨的第一端；以及
切除所述第一骨的所述第一端与所述第二骨的所述第一端中的至少一个。
16.根据权利要求15所述的方法，还包括在使所述植入件的所述螺纹部分前进到所述第二骨的所述第一端中以前在所述第二骨的所述第一端中形成导向孔。
17.根据权利要求15所述的方法，还包括使所述外科手术设备跨越所述第二骨与第三骨之间的第二关节前进并且进入到所述第三骨中。
18.根据权利要求17所述的方法，还包括将所述外科手术设备从所述第一骨、所述第二骨与所述第三骨及其与由所述植入件限定的所述凹槽的接合移除。
19.根据权利要求14所述的方法，其中所述植入件的所述螺纹部分限定与由所述凹槽限定的第二中心纵轴平行但是不共线布置的第一中心纵轴。
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US9724139B2 (en) 2017-08-08
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