CN105960211A - 用于趾间关节固定术的髓内锚定件 - Google Patents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- 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
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
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- 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
- A61B17/7283—Intramedullary pins, nails or other devices with special cross-section of the nail
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- 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
- A61B2017/681—Alignment, compression, or distraction mechanisms
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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
- A61F2/4225—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes
- A61F2002/4228—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes for interphalangeal joints, i.e. IP joints
Abstract
髓内植入件具有插入到相邻趾骨内的孔中的相对端以便矫正锤状趾以及类似的整形外科手术。植入件的后端可以是带螺纹的并且容纳在近端趾骨内的孔中。前端具有带有纵向地和/或成角度地隔开的向后朝向的咬合锚爪的非对称的尖端形状。尖的前端容纳在中间趾骨中。非对称尖端形状是自对准的,以使在无需首先纵向地对准骨的情况下能够开始进入。后端当拧入到适当位置中时可以被旋转以选择非对称尖端形状的定向。尖端前端端部被插入并且推动以使趾骨达到对接,其中植入件保持它们以防退出或旋转移动。
Description
技术领域
本公开涉及通过关节固定术修复诸如锤状趾的趾骨畸形的外科手术领域。髓内锚定结构具有非对称的锥形倒钩尖端,使得在外科手术过程中此尖端能够相对于趾骨中的纵向孔跨越开始角度的范围插入。非对称尖端构造为当完全插入时使锚定结构与孔对准,并且固定锚定结构以防从孔中退出。
背景技术
锤状趾或收缩趾是第二、第三、或第四趾的近端趾间关节的畸形,通常地产生于如果在近端趾间关节处的近端趾骨习惯性地向上定向同时更远端趾骨例如由于张紧或不良适配鞋子而向上与向下地弯曲。脚趾的肌肉与关节呈现永久收缩的锤状。磨损点可能发展成老茧或鸡眼,尤其在近端关节的上侧上。
可以通过足外科手术矫正锤状趾情形。传统锤状趾关节固定术(融合)具有在近端趾间关节处切除与融合趾骨的解剖对准的目的。通过纵向地插入通过远端趾骨以及纵向地通过远端与近端趾间关节嵌入包括一段刚性金属针的长度的称为克斯那针或克氏针的经皮髓内支撑件。克氏线的突出端在脚趾的远端处保持可进入。克氏针使趾骨在更接近共线水平构造中不能移动。在愈合足以使骨跨越近端趾骨间关节融合一段期间,例如六个星期以后,移除克氏针,即从脚趾的远端纵向地退出克氏针。
克氏针关节固定术具有一些缺点,包括需要克氏针横穿远端趾骨间关节并且潜在地非必要地干扰远端趾骨间关节。由于突出的线因此存在感染的潜在问题。另选的关节固定术技术是在不从脚趾的端部插入的情况下,使近端趾骨间关节处的脚趾切入且离位并且将髓内支撑件永久地嵌入到近端趾骨间关节处的两个趾骨中。髓内支撑件,诸如短长度的克氏针或另一个细长支撑结构,插入到向近端延伸到第三趾骨并且向远端延伸到第二趾骨中的纵向孔中。即,支撑件相对直立地插入到在近端趾骨关节处对接的两个趾骨中。
对于细长髓内支撑件来说期望的是适当地延伸到两个趾骨中以便适当的结构支撑。当趾骨对接时髓内支撑件应该在形成在两个趾骨内的孔中基本上触底,以降低远离骨融合之处的对接部的骨的移动的可能性。在形成孔以后,有必要将髓内支撑件直立地插入到两个趾骨中的一个的孔中,并且然后相对地远离彼此纵向地移动趾骨以足够的距离,从而清除髓内支撑件的突出长度。
例如,可以首先将髓内支撑件插入到近端趾间关节的近端趾骨中,向近端直到在孔中触底的点。从近端趾骨突出的髓内支撑件的长度等于下一个远端趾骨中的孔的长度从而支撑件也将在那里触底。突出长度可以,例如是下一个远端趾骨的长度的75%,即其中孔的长度。为了完成装配,趾骨被纵向地拉动分离至少髓内支撑件的突出长度。当保持趾骨共线地对准时,远端趾骨中的孔与髓内支撑件的突出端对准,并且然后沿着髓内支撑件向近端推动远端趾骨以紧紧抵靠近端趾骨。
克氏针的短的长度可以被用作永久髓内支撑件,跨越近端趾间关节桥接但是未从脚趾的端部向远端突出。还存在具有其它可获得结构的髓内锤状趾植入件。髓内支撑件的一个目的是使在关节处的对接部中的趾骨不能移动,即防止趾骨的相对移动,这可能推迟或防止它们融合。单向髓内结构是可能的,例如通过倒钩端部。例如在美国2011/0257652-罗马中公开了相反倒钩的髓内支撑件。在美国2013/0131822–路易斯中公开了一端螺纹并且另一端倒钩的实施方式。通过引用将这些公开包含于此。至少一个倒钩端部是有利的,因为当在关节处的骨被推动到倒钩髓内时,倒钩端部的尖端或锚爪接合在骨组织中,防止退出,并且在一定程度上,防止了骨的相对旋转。然而,不考虑接合结构,为了将髓内在关节处插入到两个骨的第二个中,需要通过髓内的突出长度,即将要插入到两个骨的第二个中的长度使骨纵向地分离。
此目的是重新定位在关节处基本上共线地趾骨,两个趾骨沿着它们的纵向延伸部都是水平的或者具有例如10°的略微足底弯曲,并且沿着此方向跨越关节融合趾骨。外科手术包括在关节的上侧上作出切口。此关节离位以便通过切口进入到趾骨的邻接端。可以切除趾骨的一个或两个端部。例如,可以通过修剪其近端缩短远端趾骨。在关节处的邻接的趾骨的每个中形成相对的纵向孔,例如钻孔与扩孔。髓内支撑件被插入到一个趾骨,尤其是近端趾骨内的孔中。支撑件的尺寸设计为当完全插入到近端趾骨中时突出与将其插入到下一个远端趾骨中的基本上相同的距离,两个端部在它们相应孔中都触底或者接近触底。将远端趾骨在髓内支撑件的突出端上方拉出,并且推动到突出端上。关节囊在支撑件上方被缝合并且切口被缝合闭合。趾骨通过趾骨间关节融合而愈合。
趾骨、用于容纳髓内支撑件的孔以及髓内支撑件自身的尺寸很小并且是对操作的挑战。需要用于髓内支撑件的改进的结构以及布置支撑件的改进的技术,其较少地依赖于将邻接趾骨中的孔分离并且对准到髓内支撑件的端部。
发明内容
本公开的目的是减小需要将细长髓内支撑件的端部手动地插入到骨内的孔中的对准与间距的范围,尤其是将髓内支撑件的端部上的窄的、锥形或尖的头部在待由支撑件跨越的趾间关节处插入到两个趾骨的第二个中的孔中。通过提供在支撑件上的大体圆锥锥形的但是非对称的尖端头部实现了此目的。
应该理解的是在此文本中,“尖端”不必要是锋利的端部。“尖端”包括锋利或圆角或其它端部结构,前提是在端部或“尖端”处的横向跨度小于在从端部纵向向后隔开的尖端处跨越髓内的横向跨度。在本发明的上下文中,尖端在末端处还具有小于髓内插入其中的钻孔或扩孔的内径的跨度。
在示出的实施方式中,髓内的一个端部是尖的,并且另一个端部不是尖的。例如通过将支撑件的优选的螺纹轴设定到一个趾骨中的纵向孔中,在将髓内支撑件设定到待接合的两个趾骨的第一个中以后,尖端或尖端头部突出,以便使待插入到钻孔或扩孔中突出的另一个端部保持在另一个趾骨中。
有利地突出尖端头部是非对称的,其中尖端头部的一侧相对于支撑件的纵轴比相对于与尖端头部的沿直径方向相对侧(其成较陡角度)以较缓角度成锥形。尖端头部易于被引导到两个趾骨的第二个中的纵向孔中。
尖端头部的较陡角度侧可能导致后倒钩或锚爪,与较缓角度的相对侧相比,所述后倒钩或锚爪更靠近端部或尖端,此相对侧延伸到沿着尖端头部结构从尖端端部纵向地远离的后锚爪。在一些实施方式中,尽管锚爪在距离尖端端部的不同距离处,但是锚爪距纵轴的径向尺寸基本上是相等的。
与尖端头部相对的髓内支撑件的端部可以是钝的或也可以是尖的。在一个布置中,尖端头部布置在尺寸设计为拧入第一趾骨内的孔中的螺纹轴的端部上,诸如在趾间关节处的近端趾骨内的孔中。支撑件完全地螺入到孔中。然后,在关节处的第二趾骨(在此情形中远端趾骨)通过将第二趾骨推动到尖端头部结构上而接合到髓内支撑件。这涉及尖端头部结构与趾骨相对于彼此的相对运动。
由于尖端端部的锥形结构,以及在端部处的小于孔的内径的跨度,因此可以至少短距离地将髓内支撑件的末端容易地插入到第二趾骨内的孔中,而无需首先对准第二趾骨内的孔的轴以便与髓内支撑件的轴共线。由于尖端端部前进到孔中,因此尖端端部的一个侧面可以沿着入口处的边缘滑动到孔,同时在沿直径方向相对侧上具有空间。
优选地,在插入尖端端部以前预先地旋转髓内支撑件,例如支撑件可以在螺纹轴上扭转,以便对准尖端头部结构的较缓锥形侧面以沿着边缘滑动到孔中并且沿着孔的内侧进入到容纳尖端头部的趾骨中。较长较浅倾斜侧使得能够插入尖端头部结构直到较陡角度侧与孔的边缘接触的尖端。
在相应较陡与较缓侧上的锚爪之间的沿直径方向跨度等于或者略微地大于容纳尖端头部结构的趾骨中的孔的内径。当尖端头部结构前进到第二趾骨中,髓内支撑件与第二趾骨中的孔共线地对准,以便清理边缘。此前进继续直到趾骨彼此邻接的尖端。在此尖端处,髓内通过螺纹固定在第一趾骨(例如,近端趾骨)中,并且通过尖端头部结构的锚爪或倒钩固定在第二趾骨(例如,远端趾骨)中。由于锚爪/倒钩接合在第二趾骨中的孔的侧壁中,因此第二趾骨不能退离髓内支撑件。
可以在使相对端插入到关节的邻近骨中的髓内植入件中实现上述目的与方面,以便矫正锤状趾以及用于类似的关节固定手术。相关的外科手术包括切入近端趾间关节并且使近端趾间关节离位,通常地切除趾骨中的至少一个,以及纵向地钻孔或扩孔两个趾骨以提供用于容纳植入件的孔。
植入件的后端容纳在一个趾骨内的孔中,诸如近端趾骨内的远端孔中。植入件的前端具有非对称锥形尖端头部形状,其具有纵向和/或成角度地隔开的向后朝向的咬合锚爪或倒钩。有利地,植入件的后端是带螺纹的并且由此可以通过向远端突出的尖端端部拧入到近端趾骨内的孔中。
有利地,植入件可以旋转地对准,使得尖端头部的非对称平行于矢状平面(与横向完全不同,此非对称性是垂直的)。突出的尖端头部被插入到第二孔中,即进入到中间趾骨中。尖端非对称形状是自对准的,使得在无需首先对准两个趾骨中的孔的情况下能够以相对较陡角度进入。通过在支撑件上进一步推进骨使骨对准并且通过向后朝向锚爪接合在趾骨内的孔的侧面中而将骨纵向地固定在适当位置中。
附图说明
在下面示例性实施方式的说明中,参照附图示出并且描述了公开的主题,在附图中:
图1是示出锤状趾畸形的趾骨概图。
图2和图3示出了用于利用这里公开的髓内植入件的实施方式矫正畸形的外科手术。
图4示出了完成的外科手术修复。
图5是示出具有无限长的螺纹轴的髓内植入件的非对称尖端端部的正视图。
图6是示出中间趾骨,即近端趾骨间关节的远端构件的剖视图,中间趾骨被钻孔和/或扩孔以便容纳图5的尖端端部。
图7和图8是示出在植入件的非对称锥形结构的插入阶段发生的髓内植入件与趾骨中的孔的相对对准的变化的示意图。
图9是位于趾骨内最终位置中的髓内植入件的横截面图。
图10是从侧面正视图、立体图与端视图示出的植入件的另选实施方式的视图。
图11是从侧面正视图、立体图与端视图示出的另一个另选实施方式的视图。
具体实施方式
图1示出了示例性锤状趾情形,有时定义为收缩趾,其可以在第二到第五个脚趾中展开,并且通常地涉及脚趾的逐渐增加的卷曲,使得近端趾骨22向上地(上方地)转动,并且中间趾骨24与远端趾骨26向下转动(下方地)。此情形可以产生诸如在近端趾间关节的上侧上的鸡眼32以及在足部的球部和/或在脚趾的端部处的老茧或水泡34的接触损伤,这可能是疼痛的。
锤状趾情形通过插入相同类型的髓内支撑件来外科手术地进行矫正。通常来说,从脚趾的最远端插入克斯讷针(或“克氏针”,未示出)。较短的克氏针或类似的支撑件可以嵌入近端趾骨与中间趾骨的每个中以便在骨之间延伸,并且使近端趾间关节不能移动使得趾骨更加密切地对准。在矫正锤状趾畸形的关节固定术中关节变得僵化与融合。
本公开涉及髓内支撑件35的特定形式的结构与位置,髓内支撑件35在外科手术中通过竖直地插入到形成在近端趾骨与中间趾骨的邻近端中的孔37、39中而被嵌入。植入件的尺寸设计为接合在钻孔和/或扩孔以便容纳植入件的孔中。植入件的结构,及特别地其非对称尖端头部42,使得髓内支撑件35的尖端头部端部42可以在不首先将植入件准确地对准到孔的纵轴的情况下开始进入到中间趾骨内的孔中。可以以较陡角度开始此插入。
通过持续地插入,尖端头部形状导致植入件与中间趾骨中的孔成为纵向地对准。头部形状是倒钩以允许插入但是如果拉回的话则被束缚。中间柄脚或锚爪45(图5)沿着尖端头部42的长度设置,并且优选地其它基部柄脚或锚爪47设置在尖端头部的后部,即沿着插入方向与中间柄脚或锚爪45向后隔开。此结构以防止纵向退出的方式对准并且固定地接合在骨中的孔内的髓内支撑件。
图2中示意性示出外科手术开始作出上切口以暴露近端趾间关节。韧带向外分离或移动并且关节离位,以便暴露近端趾骨22与中间趾骨24的正常对接端。通常期望的是切除近端趾骨的头部并且此外使中间趾骨的头部平坦,通过图2中的虚线示出。此切除缩短了脚趾的整体长度并且一起规划提供在近端趾骨22与中间趾骨24的端部上的朝向表面,在那里骨在相当大的端部表面积上方邻接。外科手术的目的是使具有这些表面对接的关节不能移动,并且在一段愈合与骨化期间以后跨越近端趾间关节融合两个趾骨22、24。
外科医生形成图3中示出的、相应地在近端趾骨与中间趾骨中纵向地对准并且基本上居中的孔37、39。这可能涉及钻取先导孔并且通过扩孔器(未示出)扩大先导孔或者简单地钻取具有要求内径与长度的孔。
优选地,孔37、39的长度仅略微地大于必须适合髓内支撑件35的纵向尺寸,使得髓内支撑件35完全地占据孔37、39并且有助于相应骨的结构强度。更具体地说,尖端头部42的尺寸设计为纵向地插入以沿着孔39的长度后边缘或柄脚47适当地定位中间倒钩或柄脚45,所述后边缘或柄脚47在远离边缘或者到孔39中的入口的空间处具有最大的径向尺寸。
优选地,在描述的实施方式中是带螺纹的相对端44,首先插入到近端趾骨22中,例如被拧入到孔37中返回到螺纹端44的最终位置附近。在此位置中,尖端头部端部42,包括其后边缘或柄脚47,突出超过近端趾骨22的头部并且与近端趾骨22的头部隔开。支撑件35的旋转对准可以被调节以对准与矢状平面平行的尖端头部端42的非对称。在图3和图4中示出的实施方式中,尖端头部端部42的陡峭的斜坡侧已经向下定向并且较缓的斜坡侧向上定向。
图3示出了已经沿着中间趾骨与近端趾骨的纵轴钻孔与扩孔的适当地延伸到骨组织中的孔。植入件35拧入到孔37中,使尖端头部端部42向远端突出。使中间趾骨24达到将孔的开口布置在突出的尖端头部端部42处。其中具有孔39的趾骨在突出的尖端头部端部42上方被大体上纵向地推动,直到趾骨22、24的头部达到对准,即接触。尖端头部端42的柄脚或锚爪在孔39的内表面处接合在骨组织中并且防止将植入件35从中间趾骨24相对退出。然后修复与缝合在关节处的韧带。外筋膜同样地被缝合以闭合切口。
最后结果是图4中示出的趾骨的改进的对准。髓内植入件35抵制纵向与旋转移动。植入件35使关节不能移动,并且在愈合一段期间以后,中间趾骨与近端融合。
如果髓内植入件35被插入到相应趾骨的每个中以大量距离那么就是期望的。如果植入件占据形成在距骨中的孔的长度的大部分或全部以容纳植入件那么也是期望的。在示出的实例中,植入件具有容纳在近端趾骨中的波浪状优选地螺旋螺纹端部44以及容纳在中间趾骨中的圆锥形的但是优选地非对称的尖端头部端部42。
为了相对于彼此操控中间趾骨与近端趾骨以将髓内植入件的尖端端部插入到中间趾骨内的孔中,中间趾骨与近端趾骨必须首先纵向地隔开至少植入件从近端趾骨突出的明显距离。可以远离近端趾骨向远端拉动中间趾骨,以使开口达到孔39中直到植入件35的尖端端部42的前面。通过传统的植入件,还将在此阶段操控中间趾骨以轴向地对准孔37、39。然而,公开植入件的一个方面是孔37、39无需共线,以便开始将凸出端部42插入到中间趾骨的孔中。孔可以是彼此倾斜的,尤其通过尖端端部的较陡侧抵靠将容纳尖端端部的趾骨中的孔的边缘放置接近。通过进一步前进,植入件的特定结构方便了插入处理,在插入过程中内在地对准趾骨22、24,并且固定地接合,使得趾骨相对于彼此不可移动。
参照图5,螺纹端44与孔37互补,原因在于在带螺纹的峰部处的外径略微地大于孔的内径。在带螺纹的基部处的轴的直径等于或者略微地小于孔的内径。因此,螺纹端44以自攻方式拧入到骨中。螺纹可以构造为基于患者解剖与植入件尺寸的选择而与管骨内的的松质或皮质骨接合。
通过螺纹轴44一体地形成在植入件35内的尖端头部端42,大体上成形为圆锥除了此圆锥不对称以外。(此外,如上面指出的,在此圆锥上的尖端可以是锋利的或者其可以是钝的或圆角的。)在一侧上(图5中的下侧),锥形形状仅向回引导到中间柄脚或锚爪45,其中尖端头部端部42的直径减小,离开柄脚或锚爪45。在图5中示出的实施方式中,柄脚45是底切,使得柄脚形成如示出的向后指向的边缘。在图5示出的尖端头部形状继续使锥形从柄脚45后面的底切引导到尖端头部端部42的后边缘扩大。在后边缘处直径再次减小到轴或螺纹端44。此结构形成一类端部锚爪或柄脚。由此在此实施方式中,尖端头部形状42限定在那里直径减小的多个纵向隔开的柄脚或锚爪,并且选择性地此外底切形成咬入孔39附近的骨组织的边缘,以阻碍尖端头部端部42相对于尖端端部插入其中的趾骨退出。
将可能的是定向植入件使得尖端头部端部42插入到近端趾间关节的近端骨22或远端骨24的任一个中,使得螺纹部分接合在另一个中。由于在结构上骨主要朝向脚趾的远端较小,因此其可以方便并且结构性地固定以将螺纹轴44安装在更近的近端趾骨22中并且以将尖端头部结构42嵌入到更远端中间趾骨24中。
与图5和图6相比,趾骨24中的孔39的内径D略微地小于垂直于植入件35的中心轴(虚线)测量的半径R1+R2到尖端头部结构42的相应的倒钩或柄脚45(在一侧上)和47(在端部的相对侧上)的尖端的跨度。通过此种方式,倒钩或柄脚锁定到骨中的孔的内表面中。然而,尖端头部的形状是非对称的。在另选实施方式中,相对的半径R1和R2可以是不相等的并且/或者相应的角度θ1和θ2可以是不相等的。
如图7和图8中进一步示出的尖端头部端部42的大体上尖的形状协助将尖端头部形状引导到在孔39的端部处的开口中。由于尖端头部端部42的尖端43(其可以是圆角或锋利的)小于孔39的开口,因此人们可以在无需仔细地排列孔39的边缘的中心与尖端头部形状的尖端43的情况下,并且在不用首先对准植入件的纵轴与孔成为共线的情况下开始将尖端头部42接合到孔39中。
在示出的实施方式中,尖端头部42的圆锥形侧面是直的并且逐渐变细到相对尖的尖端43。可能另选的是提供形状,其中锥部沿着曲线导致子弹形状(未示出)。还可能具有圆锥形但是使得尖端43比示出的更加钝化,例如在此尖端43处是圆角或截锥而并非锋利的。在另一个可能的布置中(未示出),锥形端部的尖端43可以是截锥,因为植入件35沿着中心轴是筒状的以便引导克氏针等,即通过在尖端43处出现的纵向通道。在其它布置中,可以提供圆锥形端部但是略微倾斜于植入件的中心轴。在又一个布置中,可以将多个倒钩或柄脚45沿着植入件设置在不同的纵向点处和/或如围绕中心轴径向地隔开。在剩余附图中示出了这些另选中的一些。
如在图7和图8中所示,在此尖端处的非对称和/或倾斜圆锥形对于与尖端头部42插入到其中的孔39的边缘与表面相互作用来说是有用的。无论是锋利或活是圆角的,尖端端部都具有小于孔的内径的跨度,使得通过通常将端部移动到较大孔中而开始插入。当尖端头部42前进到孔39中时,可以沿着入口的边缘在较陡或较缓的锥形侧上(或者沿着横向侧面)将尖端头部42引导到孔39中。当将螺纹轴拧入到近端趾骨22中时,通过旋转地选择性地对准尖端头部42,斜坡中的非对称可以平行于时装平面布置。即,人们可以将较陡或较缓斜坡选择性地布置在植入件35的上侧或下侧上。这有助于协助将尖端头部42从开始位置引导到中间趾骨24内的孔39中,其中趾骨并非已经对准,例如沿着足底方向倾斜地卷曲。在图7中,当开始插入时(这可能涉及将尖端43移动到骨24中,或者使骨25中的孔39在尖端43上方移动,或者兼具二者),尖端头部结构42沿着抵靠边缘内侧的被引导一段穿过长度直到接触抵靠边缘的相对边缘的相对侧。通过持续的插入,尖端头部端部42与植入件35作为整体与孔39共线地对准。尖端头部端部42的外径略微地超过孔39的内径,尤其在柄脚45、47处。如图9中所示,通过持续插入,首先中间柄脚45以及最终地多个柄脚45、47接合在骨组织中。旨在从骨退出尖端端部42的任何力都致使柄脚45、47的尖端掘入到骨组织中以妨碍以倒钩的方式退出。此外,在相对侧上的尖端端部42的锥部中的非对称性防止了在骨中尖端端部42的相对旋转。植入件35保持在图9以及此外图4中示出的其最终位置处。
如描述的,在此实例中近端趾间关节的骨通过包括植入件本体的髓内植入件35不能移动,植入件本体具有沿着纵轴的锚定结构,即锥形/尖端端部42。植入件35构造为沿着一个方向插入到骨24内的孔39中,以便咬住孔的侧面,并且抵制髓内植入件35沿着与插入方向相反的方向从骨退出。
髓内植入件具有尖端头部42,此尖端头部42在植入件35的前端处具有尖端43以及从此尖端以角度θ1和θ2向外与向后成锥形地到与前端向后隔开的相应咬合锚爪45、47的表面。向外地与向后地呈锥形的两个或多个表面可以是两个沿直径方向相对的表面或围绕轴以不同的角度和/或到不同径向距离成角度隔开的多个表面。如图5中所示,两个沿直径方向相对的表面以不同的角度(θ1≠θ2)向外与向后呈锥形并且/或者可以前进到不同的径向跨度(R1≠R2)或者兼具二者。在图10和图11中描述的另选实施方式中示出了此外或另外构造的呈非对称锥形表面。在描述的每个实施方式中,尖端端部42设置为可选螺纹的轴相对。尖端端部是非对称的并且承载以不同径向跨度的和/或在纵向隔开位置处的多个咬住柄脚或锚爪45、47、55,以便从前端尖端43沿着插入方向向后地引导和/或围绕尖端端部成角度地隔开。
在图10和图11中,中间锚爪55设置在围绕具有不同形状的尖端头部的周边周围的不同角度位置处。如在前面实施方式中,图10包括纵向隔开的柄脚55、47。在图11中,具有成不相等角度θ1和θ2的表面但是在此实施方式中锚爪55是单个倒钩结构。咬合锚爪45、47、55可以设置为更靠近前端并且此外进一步返回。图10和图11利用向前布置的咬合锚爪。靠近尖端43(锚爪45或55)的咬合锚爪比远离前端处的尖端43的锚爪47具有更大的向外且向后的角度,并且可以限定尖端端部42的后边缘。
如说明的,尖端头部形状42可以构造为从中心轴到锚爪或倒钩边缘的径向距离中具有差值(R1≠R2)。在这些实例的每个中,倒钩边缘或锚爪由在相应的咬合锚爪处的径向跨度中的、就在沿着插入的纵向方向的此锚爪后面的底切或急下降限定、。另外,尖端头部42的沿直径方向跨度,通常地在锚爪或倒钩45、47、55处的至少一个端部处的相对表面之间的距离大于孔39的内径。由此咬合锚爪接合在孔39的侧壁中以防止退出。在锚爪后面的底切或急下降的情形中,倒钩向后地定向并且由此布置为如果在趋于从孔39退出植入件的方向上施加力那么更深入地咬合到孔39的骨组织中。
参照图7,孔39的内径有利地大约等于或略微大于垂直于植入件的轴测量到的锚爪45的尖端与尖端端部的较缓倾斜相对侧之间的跨度。通过此种方式,当尖端端部开始进入孔39中同时尖端端部与孔39的轴倾斜时,锚爪在没有干扰的情况下穿入孔中。当如图8中所示继续插入,并且植入件的中心轴达到与孔的轴对准时,此跨度与孔39的轴垂直,并且由于垂直于植入件的轴测量的锚爪的尖端与相对侧壁趾间的垂直跨度然后大于孔39的内径,因此锚爪被推动以挖入到孔的内壁中。
如所述描述的植入件35有利地形成用于趾间关节的关节固定术的假体的至少一部分以矫正锤状趾畸形并且构造为与在所述关节处对接的两个趾骨22、24接合。有利地,与尖端头部42相对的植入件35的近端44是带螺纹的,使得植入件扭转(旋转)以将近端44拧入到近端趾骨中,而尖端头部42接合在中间趾骨中。螺纹允许植入件35旋转,使得尖端头部42的非对称实施方式的较缓或较陡侧沿着上方向或下方向定向。由此植入件35可以定向为在不用首先使尖端42或植入件35作为整体与孔39共轴对准的情况下开始插入到趾间趾骨24内的孔39中。
用于趾间关节等的外科手术修复的相关方法由此包括沿着在关节处的至少一个趾骨24中的纵向孔轴形成孔39,以便容纳包括植入件本体的髓内支撑件35,使得尖的锚定件端部42沿着纵轴朝向,其中锚定件端部具有尖端头部42,此尖端头部具有在前端处的尖端43与以不同角度向外与向后成锥形的在相应咬合锚爪45、47、55中结束的沿直径方向相对的表面。当将髓内支撑件的引导端移动到孔中时,髓内支撑件35的纵轴有利地可以与纵向孔轴倾斜地对准(参见图7)。
当沿着孔的边缘引导沿直径方向相对的表面中的一个时实现插入。髓内支撑件35的尖端或锚定件端部42前进到孔39中,孔的尺寸设计为使得一个或多个其它表面与孔的边缘和内表面接合。将关节的两个趾骨22、24推进成对接使得髓内支撑件35的纵轴达到与孔轴对准(参见图9)。在由骨的对接确定的完全插入位置处,锚定件端部定位在孔中的最终位置处,优选地邻近孔的端部。咬合锚爪45、47、55沿着骨39的壁接合在骨中并且防止退出。
有利地,植入件的近端部分具有使得植入件能够拧入到近端趾骨内的孔37中的螺纹轴。通过最终地对准平行于矢状平面的部分锥形尖端头部42的非对称部分,可以沿着尖端头部42的一个侧面上的斜坡引导尖端头部42的初始插入。非对称形状是自对准的,使得入口实质上不需要纵向对准,但是通过持续的前进足以对准骨与植入件,使得骨可以融合,同时植入件35保持骨固定并且对接。
在示例性实施方式中,植入件在一个端部上具有尖端端部形状并且在另一个端部上具有优选地但非必要带螺纹的轴。还可能的是提供朝向两个方向以便容纳在对接骨中的尖端端部。
相关的方法可以包括切入近端趾间关节以及使近端趾间关节离位,切除趾骨的至少一个并且钻孔与扩孔两个趾骨以便如所述地插入髓内植入件35。在愈合一段期间以后,趾间关节在平行于水平或足底平面的趾骨的更加正确解剖对准处融合。
已经结合具有出于上述原因有利的特征的一些实施方式公开了本发明。在不偏离本发明的情况下可以与其它特征一起或单独地实现这些特征。如与实施方式与实例的前述描述相反,应该参照所附权利要求,以便接近发明要求保护的范围。
Claims (11)
1.一种髓内植入件,包括:
植入件本体,其具有沿着纵轴朝向的锚定件端部,所述锚定件构造为沿着一个方向插入到骨中的孔中以便咬住孔的侧面,并且阻止所述髓内植入件沿着相反方向从所述骨退出;
其中,所述锚定件具有在植入件本体的前端处的锚定件头部以及从此尖端到与所述前端向后隔开的相应咬合锚爪带角度地向外与向后成锥形的表面;
其中,至少两个所述表面是相对于轴线彼此角度地隔开与纵向地隔开中的至少一个,并且以不同角度与不同径向跨度中至少一个至相应所述咬合锚爪向外且向后成锥形。
2.根据权利要求1所述的植入件,其中,沿直径方向相对表面的所述相应咬合锚爪位于距所述前端处的所述尖端的不同纵向距离处。
3.根据权利要求2所述的植入件,其中,相比远离所述前端处的所述尖端的至少一个所述咬合锚爪,更靠近所述前端的至少一个所述咬合锚爪具有更大的向外且向后成锥形的角度。
4.根据权利要求1所述的植入件,其中,沿直径方向相对表面的所述相应咬合锚爪之间的沿直径方向跨度大于所述孔的内径,由此所述咬合锚爪与所述孔的相对侧壁接合。
5.根据权利要求1所述的植入件,其中,所述植入件形成用于趾间关节的关节固定术的假体的至少一部分并且构造为用于在所述关节处对接的两个趾骨的接合。
6.根据权利要求5所述的植入件,其中,与所述前端相对的端部是带螺纹的。
7.一种用于趾间关节的外科手术修复的方法,其包括:
沿着纵向孔轴在关节处的至少一个趾骨中形成孔;
提供一种髓内支撑件,所述髓内支撑件包括具有沿着纵轴朝向的锚定件端部的植入件本体,其中所述锚定件端部具有锚定件头部,所述锚定件头部具有在前端处的尖端以及以不同角度向外与向后地成锥形的外表面;
其中至少一个所述外表面导向构造为沿着与所述前端相反的方向咬合的咬合锚爪;
倾斜于所述纵向孔轴定向所述髓内支撑件的所述纵轴并且将所述髓内支撑件的所述前端移动到所述孔中;
将所述锚定件端部推入到所述孔中,由此使所述髓内支撑件的所述纵轴达到与所述孔轴对准;以及
继续推进锚定件端部到孔中到端部位置,在所述端部位置处所述咬合锚爪与所述孔接合以防止退出。
8.根据权利要求7所述的方法,还包括将与所述前端相对的端部插入到第二趾骨中并且旋转地对准所述髓内支撑件,使得在将所述前端移动到所述孔中以前,所述不同角度平行于矢量平面定向。
9.根据权利要求7所述的方法,其中与所述前端相对的所述端部是带螺纹的,其中所述插入与所述前端相对的所述端部包括将所述髓内支撑件拧入到所述第二趾骨中。
10.根据权利要求7所述的方法,其中所述植入件本体具有螺纹轴并且还包括将所述螺纹轴拧入到所述第二趾骨中,以便保持所述锚定件端部突出超过所述第二趾骨。
11.根据权利要求10所述的方法,还包括旋转所述螺纹轴以将所述外表面选择性地布置在适当位置处以便沿着所述孔的所述边缘引导。
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- 2014-12-19 WO PCT/US2014/071526 patent/WO2016099550A1/en active Application Filing
- 2014-12-19 EP EP14861184.1A patent/EP3232960A4/en not_active Withdrawn
- 2014-12-19 US US14/420,260 patent/US10080597B2/en active Active
- 2014-12-19 BR BR112017000207A patent/BR112017000207A2/pt not_active Application Discontinuation
- 2014-12-19 JP JP2016544467A patent/JP6438033B2/ja not_active Expired - Fee Related
- 2014-12-19 CA CA2889595A patent/CA2889595C/en not_active Expired - Fee Related
- 2014-12-19 AU AU2014334525A patent/AU2014334525B2/en not_active Ceased
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CN108578021A (zh) * | 2018-05-18 | 2018-09-28 | 苏州玄陶商务咨询有限公司 | 一种植入工具 |
CN108578021B (zh) * | 2018-05-18 | 2024-03-15 | 苏州黑桃医疗科技有限公司 | 一种植入工具 |
Also Published As
Publication number | Publication date |
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CA2889595C (en) | 2018-01-16 |
EP3232960A1 (en) | 2017-10-25 |
WO2016099550A1 (en) | 2016-06-23 |
US10080597B2 (en) | 2018-09-25 |
AU2014334525B2 (en) | 2017-05-25 |
CA2889595A1 (en) | 2016-06-19 |
JP2017503583A (ja) | 2017-02-02 |
JP6438033B2 (ja) | 2018-12-12 |
US20160338747A1 (en) | 2016-11-24 |
EP3232960A4 (en) | 2018-08-15 |
BR112017000207A2 (pt) | 2018-01-16 |
AU2014334525A1 (en) | 2016-07-07 |
CN105960211B (zh) | 2019-01-11 |
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