CN110448369B - 矫形植入套件 - Google Patents

矫形植入套件 Download PDF

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CN110448369B
CN110448369B CN201910770339.2A CN201910770339A CN110448369B CN 110448369 B CN110448369 B CN 110448369B CN 201910770339 A CN201910770339 A CN 201910770339A CN 110448369 B CN110448369 B CN 110448369B
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screw
cylindrical body
hollow cylindrical
rotatable shaft
longitudinal housing
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M·拜尔
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Neo Medical SA
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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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7038—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other to a different extent in different directions, e.g. within one plane only
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7076—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
    • A61B17/7077—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation for moving bone anchors attached to vertebrae, thereby displacing the vertebrae
    • A61B17/708—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation for moving bone anchors attached to vertebrae, thereby displacing the vertebrae with tubular extensions coaxially mounted on the bone anchors
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    • A61B17/7083—Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
    • A61B17/7085—Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements for insertion of a longitudinal element down one or more hollow screw or hook extensions, i.e. at least a part of the element within an extension has a component of movement parallel to the extension's axis
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    • 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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7091—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for applying, tightening or removing longitudinal element-to-bone anchor locking elements, e.g. caps, set screws, nuts or wedges
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    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter

Abstract

一种矫形植入套件，包括螺钉扩展器，其包括：包含两个相对的纵向狭缝的中空圆柱形主体，所述狭缝具有朝向所述中空圆柱形主体的远端部分的开口端部，所述远端部分构造为通过沿所述中空圆柱形主体的主轴方向插入以接收螺钉，所述中空圆柱形主体包括内部螺纹；具有外部螺纹的螺钉操作工具，所述外部螺纹构造为与所述螺钉扩展器的中空圆柱形主体内部的内部螺纹螺纹接合，所述螺钉操作工具包括：纵向外壳；位于所述纵向外壳内部的可旋转轴，所述可旋转轴具有构造为与所述螺钉接合的远端部分；以及阻止机构，所述阻止机构构造为在阻止位置相对于所述纵向外壳阻止可旋转轴的旋转，并且构造为在非阻止位置相对于所述纵向外壳允许所述可旋转轴的旋转。

Description

矫形植入套件
本申请是申请号为201480027310.0、申请日为2014年4月24日、发 明名称为“矫形植入套件”的PCT国际发明专利申请的分案申请。
技术领域
本发明涉及矫形术，并且更具体地涉及矫形器具，例如，椎弓根螺钉、 杆和脊柱笼。本发明还涉及用于操作这些器具的工具。
背景技术
US 2013/0012999公开了一种矫形植入套件，其包括若干器具，特别 是固定到安装管上的椎弓根螺钉，该安装管由两个能够轻易拆卸的半壳制 成。
现有技术的椎弓根螺钉可以被分为两大类：
-单轴螺钉：螺钉主轴的方向相对于螺钉头固定；
-多轴螺钉：螺钉主轴的朝向可以相对于螺钉头自由地改变。
当将椎弓根螺钉植入骨头时，需要若干步骤。这些步骤中的几乎每一 个都需要使用专门的工具。
发明内容
本发明的一个目的在于降低操作和固定矫形植入物(椎弓根螺钉、螺 母、杆等)所需的器具的数量。
另一个目的在于降低用于操作这些器具的工具的数量。
又一个目的在于辅助操纵这些工具。
利用植入套件以及相关的器具和工具来满足这些目的。
在本发明的第一实施方式中，一种矫形植入套件包括可锁定多轴螺 钉、组织膨胀套、螺钉驱动器、螺钉扩展器、杆、杆复位装置、定位螺钉 驱动器、扭矩限制机构以及螺钉释放工具。
根据本发明的可锁定多轴矫形螺钉包括头部和螺纹部，它们形成两个 分离的元件，其固定到彼此，但每个元件可以沿着特定方向独立地取向。 例如，螺纹部可以绕着螺钉头部旋转并且可以采用若干可能的取向。更准 确地说，螺纹部可以在圆锥体积内朝向任何方向，圆锥的顶点对应于头部 和螺纹部之间的接触点。
螺钉还包括锁定元件，当激活时，锁定元件抑制螺纹部和头部之间的 相对运动。这种配置被称为“单轴”，因为螺纹部可以相对于头部沿着单个 (固定)轴取向。根据一种实施方式，锁定元件是具有U形形状的夹具。 在这种情况下，头部和螺纹部包含腔室，这些腔室适于接收U形夹具的分 支。
优选地，在单轴模式中，头部仍然可以自由地绕其自身的轴、相对于 螺纹部旋转。可以利用U形夹具和位于螺纹部的上部分周围的环形槽获得 这种机构。在这种情况下，夹具的分支滑入到环形槽中。
在另一种实施方式中，螺钉头部包括至少一个纵向解除机构，例如槽 或脊，其尺寸设计成用于接收相应的解除机构，例如位于螺钉扩展器的远 端内的脊或槽。
在另一种实施方式中，螺钉包括位于螺纹部的近端中的凹座以及位于 螺钉头部的远端部分的相应凸形。这种配置降低了螺钉长度，并且增加了 系统的强度和刚性。
根据本发明的螺钉扩展器包括中空的圆柱形主体，其由两个半管制 成，这两个半管由两个相对的纵向狭缝分离，狭缝具有朝向圆柱主体远端 部分的开口端，该远端部分的尺寸设计成接收和保持螺钉头部。圆柱形主 体还包括内部螺纹部分。
根据一种实施方式，其中，圆柱形主体由单一件制成，其中，远端部 分借助其自身的弹性可径向扩展，从而允许螺钉头部的简易夹持和随后的 释放。
为了辅助其径向扩展，螺钉扩展器可以包括扩展装置，例如内部可旋 转管，当其旋转时推动两个半管彼此远离。
在优选实施方式中，圆柱形主体远端的内部包含至少一个解除机构， 例如脊或槽，其尺寸设计成接收在螺钉头部(其包括相应的解除机构，如 上所述)的纵向解除机构中。利用这种配置，其阻止了半管的远端部分通 过其自身的弹性彼此分离，从而形成了螺钉扩展器和螺钉头部之间的极为 牢固的附接。额外的好处是，避免了螺钉头部和圆柱形主体之间的相对旋 转。
在优选实施方式中，杆复位工具位于圆柱形主体内。
有利地，杆复位工具基本上由具有螺纹远端部分的轴制成，该螺纹远 端部分是圆柱形主体内部螺纹部分的对应部分。所以，当其在圆柱形主体 内旋转时，轴可以沿着圆柱形主体的主轴移动。
在另一种实施方式中，定位螺钉驱动器(同样地，或者可选地)位于 所述圆柱形主体内。在这种情况下，同样地，定位螺钉驱动器也可以基本 上由具有螺纹远端部分的轴制成。
有利地，定位螺钉驱动器包括扭矩限制机构。
在一种实施方式中，这种机构包括可破裂销以及无螺纹的可旋转轴。 销横向地穿过可旋转轴并且其端部固定在螺纹可旋转轴内。螺纹和无螺纹 的轴可旋转地联接到彼此，但当达到特定的扭矩时，销断裂，并且各轴可 以相对于另一轴自由地旋转。
在另一种实施方式中，螺钉释放工具(同样地，或者可选地)位于所 述圆柱形主体内。
有利地，螺钉释放工具基本上由具有螺纹远端部分的轴制成。
在一种特别令人感兴趣的实施方式中，具有螺纹远端部分的相同轴被 用于杆复位工具(以及潜在的脊椎滑脱)、定位螺钉驱动器和螺钉释放机 构。
根据本发明的组织膨胀套包括柔性圆锥部分，其适于临时性地固定到所限定的螺钉扩展器的工具的远端部分。
在一种实施方式中，圆锥部分由若干纵向的柔性叶片制成，每个叶片 均具有大体上三角形的形状。
附图说明
在下文中，结合附图所示出的非限制性实例，将更好地理解本发明， 附图中：
图1示出了根据本发明的植入套件。
图2示出了根据本发明的可锁定的多轴椎弓根螺钉的实例。
图3A至3C是图2的螺钉的横截面和部分切出视图。
图4表示图2的螺钉的不同视图(完整的和部分的)。
图5示出了根据本发明的螺钉扩展器的远端部分，以及图2的螺钉。
图6是螺钉扩展器远端部分的横截面。
图7是具有螺钉的螺钉扩展器的全局视图。
图8A至8C表示杆在螺钉头部中的定位、杆复位以及定位螺钉的收紧。
图9A至9C示出了螺钉相对于螺钉扩展器的释放。
图10示出了螺钉扩展器，其包括用于横向扩展螺钉扩展器远端部分 的机构。
图11是图10的螺钉扩展器的另一表示。
图12示出了根据本发明的椎弓根螺钉的另一实施方式。
图13A至13C示出了一可旋转轴的不同视图，该可旋转轴用在杆复位 工具、定位螺钉驱动器和螺钉释放工具中。
图14和15示出了扭矩限制机构。
图16和17示出了组织膨胀套的使用。
图18至38示出了利用根据本发明的植入套件的手术程序。
附图标记说明：
1.椎弓根螺钉
2.头部
3.定位螺钉
4.螺纹部
5.锁定元件
6.螺钉扩展器
7.杆
8.多功能工具的上部分
9.组织膨胀套
10.扭矩驱动器
11.头部通道
12.螺纹部分通道
13.分支
14.圆柱形主体
15.狭缝
16.圆柱形主体远端部分
17.脊
18.槽
19.螺钉扩展器内部螺纹部分
20.多功能工具的下部分
21.圆锥部分
22.叶片
23.半管
24.螺钉驱动器
25.手柄
26.多功能工具(杆复位/定位螺钉驱动器/螺钉释放)
27.杆插入工具
28.可断销
29.横向销
30.圆形槽
31.穿刺针/导丝
32.凹螺钉顶部
33.凸的上半球
具体实施方式
下文的实例更恰当地涉及由结合了一次性使用工具的椎弓根螺钉和 杆组成的胸腰椎融合系统。典型的椎弓根螺钉系统由螺钉植入物和用于置 放螺钉的工具组成。
图1示出了根据本发明的植入套件的实例。
该套件包含组织膨胀套9、手柄25、杆7、杆插入工具27、可用作杆 复位工具和/或定位螺钉驱动器和/或螺钉释放工具的轴26、椎弓根螺钉1、 螺钉扩展器6以及螺钉驱动器24。
具体在图2至4中示出的可锁定多轴螺钉1包括头部2和螺纹部4。 图2还示出了定位螺钉3，其在杆7插入之后可以固定到头部。螺钉1还 包括U形形状的锁定元件5。当锁定元件5完全插入在螺钉头部2中时， 螺纹部4相对于头部2的取向被阻止。相反，当锁定元件被拔出时，螺纹 部4可以相对于螺钉头部2自由地取向。
因此，根据本发明的可锁定多轴螺钉可以变形成单轴螺钉，由此允许 在同一产品中具有单轴和多轴功能。先前限定的阻止系统允许外科医生选 择他/她想要使用单轴模式还是多轴模式的螺钉。如所述的，通过推入锁定 元件(夹具)5而实现单轴功能，并且通过移除夹具5而实现多轴功能。 夹具5仅仅是阻止系统的一个实例；也可以设想其他技术方案，例如销。
优选地，在单轴模式中，头部仍然可以自由地绕其自身的轴、相对于 螺纹部旋转。可以利用U形夹具和位于螺纹部的上部分周围的环形槽获得 这种机构。在这种情况下，夹具的分支滑入到环形槽中。
当使用单轴时，可以考虑轴的任何取向，即，螺钉轴和螺钉头部可 以沿着不同的方向定向。
图5至7表示通过将螺钉头部2插入到远端16而使椎弓根螺钉1附 接到螺钉扩展器6的远端16。在这种操作中，利用位于远端16内的多个 脊17以及位于头部2上的槽来引导头部2。利用这种系统，螺钉头部可以 更好地保持在螺钉扩展器6中。
任何合适的材料可以用于螺钉扩展器6(塑料、聚合物、金属等……)。
图8A至8C表示杆7在螺钉头部2中的定位、杆复位以及定位螺钉3 在螺钉头部2中的收紧。
多功能工具26(也可参见图13A至13B)由上部分8和下(螺纹)部 分20限定。
可以通过在圆柱形主体14内旋转多功能工具26而向下推动杆7。
在杆插入到头部2中之后，定位螺钉3通过进一步旋转多功能工具26 而固定到头部2。
多功能工具26还配备有扭矩限制机构(参见图14和15)。当定位螺 钉3固定在头部2中并且多功能工具26进一步旋转时，扭矩增加，直至 使销28断裂的水平。因此，多功能工具26的进一步旋转不会对定位螺钉 3产生影响。从那时开始，多功能工具26的进一步旋转仅在螺钉头部2上 产生向下的压力。因此，螺钉1逐渐与螺钉扩展器分离(参见图9A至9C)。
这种来自工具的螺钉释放机构提供了在不横向扩张螺钉扩展器6的情 况下从螺钉扩展器释放螺钉1的可能性。
在此阶段，值得一提的是，这种机构不限于释放椎弓根螺钉。可以使 用任何其他器具。
总之，相同的工具26可以用于杆复位，用于将定位螺钉固定到螺钉 头部，以及用于从螺钉扩展器释放螺钉。
应该强调的是，本发明不限于同一工具的上述三种用途。还可以包括 两用，例如，杆复位和螺钉组至螺钉头部的固定。
图10和11示出了将椎弓根螺钉附接至螺钉扩展器的替代方案，通过 旋转内管(未示出)，半管23借助其自身的弹性扩张。这允许螺钉插入并 固定到其中，例如通过夹持螺钉周围的外表面。相同的原理可以用作将螺 钉扩展器与螺钉分开的替代方式。
夹持系统还通过抵靠在螺钉头部的支撑表面上而实现了其部分刚性。
图12示出了凹螺钉顶部32，其内部是凸的上半球33，这允许杆7和 定位螺钉3定位在螺钉头部2的下部，由此降低整个构造的高度，并且增 加系统的强度和刚性。
图16和17表示组织膨胀套9，其包含四个三角形柔性叶片22，它们 彼此干预并且形成圆锥21。圆锥21利用可撕下的螺旋物安装在螺钉扩展 器6的尖端上。这允许当螺钉扩展器6插入到身体中时组织被推开。一旦 就位，手术医生可以移开套9，而螺钉扩展器保持在身体中。任何适当数 量的叶片可以用于形成圆锥。
图18至38示出了利用先前呈现的器具的手术过程。
在第一个步骤中(图18和19)，两个穿刺导丝31被定位在脊柱中。
附接有螺钉1并且由膨胀套围绕的第一螺钉扩展器6随后穿过组织 (图20和21)并且沿着导丝31被插入。螺钉扩展器6被旋转和/或推动。
对第二螺钉扩展器6和螺钉1进行类似的操作(图22和23)。
螺钉驱动器24被插入到螺钉扩展器6中。其远端被引入到螺钉的螺 纹部4的上部。螺钉1随后被旋转并且进入椎骨(图24和25)。
移除组织膨胀套9(图26至28)。
杆7位于其端部的杆插入工具27横向地穿越组织(图29和30)。
杆7位于螺钉头部2之上(图32)，并且多功能工具26被引入到螺钉 扩展器6中，使得定位螺钉3位于杆7之上，与螺钉头部2成一直线(图 31和32)。
图33至36示出了杆布置在螺钉头部2中，并且定位螺钉3固定在螺 钉头部2。
图37和38示出了螺钉从螺钉扩展器6中释放，并且螺钉1、杆7和 螺钉组3处于其最终位置。
当然，本发明不限于这些示例性实例。
根据本发明的螺钉扩展器可以与单轴、多轴或可锁定多轴螺钉一起使 用。

Claims (4)

1.一种矫形植入套件，所述矫形植入套件包括螺钉扩展器，所述螺钉扩展器包括：
包含两个相对的纵向狭缝的中空圆柱形主体，所述狭缝具有朝向所述中空圆柱形主体的远端部分的开口端部，所述远端部分构造为通过沿所述中空圆柱形主体的主轴方向插入以接收螺钉，所述中空圆柱形主体包括内部螺纹；
具有外部螺纹的螺钉操作工具，所述外部螺纹构造为与所述螺钉扩展器的中空圆柱形主体内部的内部螺纹螺纹接合，所述螺钉操作工具包括：
纵向外壳；
位于所述纵向外壳内部的可旋转轴，所述可旋转轴具有构造为与所述螺钉接合的远端部分；以及
阻止机构，所述阻止机构构造为在阻止位置相对于所述纵向外壳阻止可旋转轴的旋转，并且构造为在非阻止位置相对于所述纵向外壳允许所述可旋转轴的旋转，
其中，所述阻止机构包括可破裂销，所述可破裂销横向地穿过纵向外壳和可旋转轴的至少一部分。
2.根据权利要求1所述的矫形植入套件，其中，所述阻止机构构造为与所述纵向外壳和所述可旋转轴接合的扭矩限制装置。
3.根据权利要求2所述的矫形植入套件，其中，所述扭矩限制装置构造为在阻止位置相对于所述纵向外壳阻止可旋转轴的旋转，并且到达一定扭矩后，所述扭矩限制装置就构造为在非阻止位置相对于所述纵向外壳允许所述可旋转轴的旋转。
4.根据权利要求1所述的矫形植入套件，其中，在所述阻止位置，所述螺钉操作工具与所述中空圆柱形主体一起构造成螺钉驱动器，以通过经所述可旋转轴的远端部分的接合相对于所述中空圆柱形主体转动所述螺钉，并且在所述非阻止位置，所述螺钉操作工具与所述中空圆柱形主体一起构造成螺钉释放装置，以沿所述中空圆柱形主体的主轴方向推动所述螺钉远离所述中空圆柱形主体的远端部分，以释放所述螺钉。
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