CN107106187A - 固定导向装置 - Google Patents

固定导向装置 Download PDF

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CN107106187A
CN107106187A CN201580061403.XA CN201580061403A CN107106187A CN 107106187 A CN107106187 A CN 107106187A CN 201580061403 A CN201580061403 A CN 201580061403A CN 107106187 A CN107106187 A CN 107106187A
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blade
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G·维亚尔特
J·Y·勒罗伊
B·克瑞尔
S·舒伦尔
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Clariance SAS
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    • 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
    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1757Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the spine
    • 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
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/846Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
    • A61B17/848Kirschner wires, i.e. thin, long nails
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • 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
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • 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
    • A61B17/8897Guide wires or guide 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
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7076Tools 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
    • A61B17/7082Tools 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 driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00862Material properties elastic or resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect

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Abstract

本发明涉及一种能够在外科手术期间放置并引导骨锚固螺钉(4)的固定导向装置。根据本发明,所述装置包括导向销(2),所述导向销(2)具有由两个叶片(21、22)组成的可弹性变形的二分叉自由端(20),所述二分叉自由端(20)具有第一“闭合”配置,其例如由人工压缩获取以便将所述叶片(21、22)与所述导向销(2)的纵向轴线对齐地定位,以使得所述导向销(2)能够插入在导向管(3)中并放置在手术部位上,并且具有第二“打开”配置,以便在所述叶片(21、22)处于导向管(3)的外部时,将所述叶片(21、22)定位在两个相反方向上在一个相对方向上并基本上垂直于所述导向销(2)的纵向轴线的方向,以便在锚固螺钉(4)放置期间提供骨支撑。

Description

固定导向装置
本发明涉及一种能够在外科手术期间(例如像,在微创手术期间)放置并引导骨锚固螺钉的固定导向装置。
值得注意的是,在脊柱的脊髓节段的融合治疗领域,导向销型导向装置的使用尚处于发展过程中。
应注意的是,在安装椎弓根螺钉期间,使用导向装置具有在松质骨中驱动导向销向前的风险。
实际上,导向销在其自由端处的轮廓在此向前驱动过程中可以引起对敏感器官的损伤。
为了避免这种情况,外科医生使用射线照相图像进行永久性检查,以控制导向销的定位。
大量的此类照片对于手术室内存在的患者、外科医生和医护人员而言是不利的,因为他们要经受高剂量的x射线。
根据本发明的固定导向装置的目的在于,通过防止导向销向前运动并由此限制必要的射线照相图像的数目和所产生的对x射线的暴露来应对上述缺点。
根据本发明的固定导向装置包括导向销,所述导向销具有由两个叶片组成的可弹性变形的二分叉自由端,所述二分叉自由端在一方面具有第一所谓的“闭合”配置,其例如由人工约束获取以便将所述叶片定位在所述导向销的纵向轴线的延长部分中,从而允许导向销插入到导向管中以将其定位在手术部位上,并且在另一方面具有第二所谓的“打开”配置,以便在叶片处于导向管的外部时,将所述叶片定位在两个相反方向上并基本上垂直于所述导向销的纵向轴线的方向,以便确保在锚固螺钉被插入时能支撑骨。
根据本发明的固定导向装置包括导向销,所述导向销的叶片在所谓的“打开”位置中具有相对于纵向轴线的处于2与3毫米之间的曲率半径。
根据本发明的固定导向装置包括导向销,所述导向销的每个叶片的自由端在所谓的“打开”位置中以8与12毫米之间的距离间隔开。
根据本发明的固定导向装置包括导向销,所述导向销的每个叶片的自由端在其外半径上分别具有提供骨支撑的平点。
根据本发明的固定导向装置包括由镍钛诺型超弹性合金制成的导向销。
根据本发明的固定导向装置包括外径小于1,60毫米的导向销。
根据本发明的固定导向装置包括导向销,所述导向销的二分叉端在所谓的“闭合”位置中具有的外径小于导向销的外径。
通过非限制实例的方式给出的参考附图作出的描述将能够更好地理解本发明、其展示的特性以及其能够提供的优势:
图1和图2是示出根据本发明的固定导向装置的导向销的视图。
图3至图7是示出根据本发明的固定导向装置的导向销的脊髓节段在脊椎中的定位的视图。
图8至图9是示出在根据本发明的固定导向装置的导向销周围的椎弓根螺钉引导的视图。
图1和图2示出根据本发明的固定导向装置1,所述固定导向装置由例如以镍钛诺型弹性合金制成的导向销2组成。
导向销2具有的外径必须小于1,60毫米,以便能够在导向管3内滑动。
导向销2包括由两个叶片21、22构成的可弹性变形的二分叉自由端20,所述二分叉自由端20具有第一所谓的“闭合”配置,以便将所述叶片21、22定位在所述销2的纵向轴线的延长部分中,并且允许所述销2插入到导向管3中以将其定位在手术部位中。
由于导向销2的弹性特性,二分叉自由端20的两个叶片21、22具有第二所谓的“打开”配置,以便在叶片位于例如导向管3外部时,将所述叶片21、22定位在相反方向上并基本上垂直于所述销的纵向轴线的方向,以便确保在锚固螺钉4被放置时能支撑骨。
叶片21、22在所谓的“打开”位置中具有相对于导向销2的纵向轴线的处于2与3毫米之间的曲率半径。
应注意的是,每个叶片21、22的自由端在所谓的“打开”位置中以8与12毫米之间的距离间隔开。
每个叶片21、22的自由端在其内面(即,在“闭合”位置中彼此面对的面)上分别具有平点23,所述平点23确保在所谓的“打开”位置中能支撑骨。
在所谓的“打开”位置中,叶片21和叶片22的曲率半径和所述叶片的自由端之间的距离的结合允许将平点23定位在基本上垂直于导向销2的纵向轴线的平面中。
在所谓的“闭合”位置中,导向销2的二分叉端20例如具有的外径小于所述导向销的主体的外径。通过对叶片21、22的外面进行机加工来减小叶片21、22的厚度,使二分叉端20的外径减小。
根据另一非限制性实例,在所谓的“闭合”位置中,导向销2的二分叉端20可具有的外径与所述导向销的主体的外径相同。
每个叶片21、22还包括有助于将导向销2引入到导向管3中的锥形端轮廓。
在所谓的“闭合”位置中,叶片21、22通过狭槽24彼此间隔开,确保二分叉端20具有一定的弹性,以便允许导向销2插入在导向管3内部中。
图3至图7示出用于将根据本发明的将固定导向装置1放置在骨元件(例如,脊椎Ve)中以用于固定椎弓根螺钉4的各个步骤。
为了放置导向销2,必需预先将直插管5插入到脊椎Ve的主体中,穿过皮质骨并以预定深度将其定位在皮质骨的松质骨中(图3)。
随后,在使二分叉端20的叶片21、22彼此靠拢以便使叶片21、22保持在所谓的“闭合”位置中之后,将导向销2手动引入到导向管3中(图4)。
将导向管3和导向销2插入到直插管5内部,直到所述管的头部30被推入到所述直插管的啮合头部50上的支点中(图5)。
直插管5在脊椎Ve的椎体中的位置决定导向销2在后者中的位置。
实际上,由于导向管3停放在直插管5上,这足够将导向销2从所述导向管推动出来,以使得导向销由于其弹性材料而伸展,并且叶片21、22偏离所述销的纵向轴线并以停放在松质骨中结束(图5)。
直插管5和导向管3从脊椎Ve移除,以便仅将根据本发明的固定导向装置1的导向销2留在所述脊椎Ve中的适当位置中(图6、图7)。
图8和图9示出在根据本发明的固定导向装置1的导向销2周围的椎弓根螺钉4的引导。
椎弓根螺钉4包括内孔40,所述内孔40从一个侧面打开至另一侧面并且使椎弓根螺钉4能够放置在导向销2周围。借助与夹头41配合的合适螺丝刀,使椎弓根螺钉4螺旋进入脊椎Ve的主体内部。
当使椎弓根螺钉4螺旋进入时,所述螺钉4通过导向销2轴向地引导在脊椎Ve的主体内部。
考虑当椎弓根螺钉4的自由端(与夹头41相对)位于导向销2的二分叉端20的叶片21、22附近时,椎弓根螺钉4处于脊椎Ve中的适当位置中。
在向导向销2施加的张力下,二分叉端20的叶片21、22变形成所谓的“闭合”位置,以便在应力下穿透在螺钉4的内孔40中并且允许移除所述导向销2。
导向销2具有在紧固椎弓根螺钉4后阻碍自身即在脊椎Ve的松质骨内向前驱动,由此避免对椎体前面的敏感器官造成任何损伤风险的优势。
导向销2还限制射线照相图像的数目和对手术室中存在的患者、外科医生和医护人员的x射线暴露。
另外,应理解的是,以上描述仅以实例形式给出,并且不以任何方式限制本发明的范围,并且通过任何其他等效物替换其中描述的执行细节将不属于本发明的范围之外。

Claims (7)

1.一种用于在手术过程期间定位并引导骨锚固螺钉(4)的固定导向装置,其特征在于所述固定导向装置包括导向销(2),所述导向销(2)具有可弹性变形的并且由两个叶片(21、22)组成的二分叉自由端(20),所述二分叉自由端(20)在一方面具有第一所谓的“闭合”配置,其例如由人工应力获取以便将所述叶片(21、22)定位在所述导向销(2)的纵向轴线的延长部分中,从而允许所述导向销(2)插入到导向管(3)中以将其定位在手术部位上,并且在另一方面具有第二所谓的“打开”配置,以便在所述叶片(21、22)处于所述导向管(3)的外部时,将所述叶片(21、22)定位在两个相反方向上并基本上垂直于所述导向销(2)的纵向轴线的方向,以便确保在所述锚固螺钉(4)被插入时能支撑骨。
2.根据权利要求1所述的固定导向装置,其特征在于所述导向销(2)的所述叶片(21、22)在所述所谓的“打开”位置中具有相对于纵向轴线的处于2与3毫米之间的曲率半径。
3.根据权利要求1所述的固定导向装置,其特征在于所述导向销(2)的每个叶片(21、22)的所述自由端在所述所谓的“打开”位置中以8与12毫米之间的距离间隔开。
4.根据权利要求1所述的固定导向装置,其特征在于所述导向销(2)的每个叶片(21、22)的所述自由端在其外半径上分别包括提供骨支撑的平点(23)。
5.根据权利要求1所述的固定导向装置,其特征在于所述导向销(2)由镍钛诺型的超弹性合金制成。
6.根据权利要求1所述的固定导向装置,其特征在于所述导向销(2)具有小于1,60毫米的外径。
7.根据权利要求6所述的固定导向装置,其特征在于所述导向销(2)具有二分叉端(20),所述二分叉端(20)的外径在所述所谓的“闭合”位置中小于所述导向销的外径。
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FR3028407B1 (fr) 2020-10-02
AU2015344908A1 (en) 2017-05-25
WO2016075401A1 (fr) 2016-05-19
RU2017116142A (ru) 2018-12-14
US20170319251A1 (en) 2017-11-09
BR112017009960A2 (pt) 2018-02-14
CA2966590A1 (fr) 2016-05-19
MX2017006209A (es) 2018-03-23

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