CN104783887A - 一种高强度骨螺钉座 - Google Patents

一种高强度骨螺钉座 Download PDF

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CN104783887A
CN104783887A CN201510225978.2A CN201510225978A CN104783887A CN 104783887 A CN104783887 A CN 104783887A CN 201510225978 A CN201510225978 A CN 201510225978A CN 104783887 A CN104783887 A CN 104783887A
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screw
thread
nail seat
fastening
main body
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郝定均
邬春辉
郑修军
寇万福
王晗
高亚军
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Shandong Weigao Orthopedic Materials Co Ltd
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Shandong Weigao Orthopedic Materials Co Ltd
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Priority to PCT/CN2016/080782 priority patent/WO2016177303A1/zh
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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
    • 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
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007—Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
    • 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
    • A61B17/7056—Hooks with specially-designed bone-contacting part
    • 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
    • A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • 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
    • A61B17/7074—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
    • 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
    • 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

一种高强度骨螺钉座，涉及脊椎手术用医疗器械技术领域，包括钉座主体和紧固螺塞，其特征在于紧固螺塞上的外螺纹上侧面从牙顶至螺牙的牙高0.2-0.8倍处设有向上凸起的外挡块，钉座主体上部内侧的内螺纹下侧面从牙顶至螺牙的牙高0.8-0.2倍处设有向下凸起的与外挡块相配合的内挡块；钉座主体的轴向剖面中，钉座主体上部内侧的内螺纹上侧面的剖面线与钉座主体的轴线呈30°-75°夹角；紧固螺塞的轴向剖面中，紧固螺塞上的外螺纹下侧面的剖面线与紧固螺塞轴线呈30°-75°夹角。本发明具有结构简单,锁紧效果佳，钉壁不易张开，螺牙不易断裂，安全性高等优点。

Description

一种高强度骨螺钉座
技术领域 
本发明涉及脊椎手术用医疗器械技术领域，详细讲是一种结构简单、紧固螺塞可以将连接棒牢固锁定，锁定效果佳，螺牙不易断裂，安全性高的防张开防断裂的高强度骨螺钉座。
背景技术
我们知道，目前在骨科疾病的外科手术中用到的螺钉有单轴螺钉、单平面螺钉和万向螺钉，上述骨螺钉均包括螺钉座和螺钉，螺钉座下端部与螺钉相连，螺钉座用于安装连接棒。现有的上述骨螺钉的螺钉座均包括钉座主体和紧固螺塞，钉座主体内纵向设有装配孔，钉座主体上部设有用于穿设连接棒的U形槽，U形槽两侧的钉座主体内壁上设有内螺纹，紧固螺塞与钉座主体内壁上的内螺纹相配合的设在钉座主体上部内。现有螺钉座的螺纹有很多类型，如矩形螺纹，偏梯形螺纹，负角度偏梯形螺纹等。这些类型螺纹的螺钉座普遍存在两个缺点，一、当紧固螺塞对连接棒施加压力时，U形槽两侧的螺钉座向外张开，压力过大时，内螺纹和部分外螺纹脱离，螺牙破坏；二、当紧固螺塞对连接棒施加的压力过大时，钉座主体内壁上的内螺纹和与其配合的紧固螺塞上的外螺纹的螺牙易出现剪切断裂，上述情况都会导致植入体内的螺钉失效而无法使用，必须从病人体内取出，严重影响了手术的安全。负角度的偏梯形螺纹是目前椎弓根螺钉使用最广泛的牙型，螺牙的受力面上角度一般为-4至-5度，这种螺牙本身的强度较高，负角度在一定程度上也能够防止U形的螺钉座张开。 但是当螺塞上施加的扭矩比较大时，还是容易出现上述两个问题。尽管自断螺塞可以限制螺塞上的扭矩，但是有些手术操作有可能在自断螺塞自断以后需要重新拧紧螺塞，这样医生就有可能会施加过大的扭矩而导致螺钉座和螺塞发生破坏，此类问题在临床中时有发生，而要取出破坏的螺钉，则需要松开同侧的所有螺钉，严重影响产品的使用体验，并给病人带来巨大的风险，不仅延长了手术时间，而且增加了出血和感染的风险，在微创手术中出现此类问题时甚至需要转为开放手术而加大对病人的创伤。螺旋法兰技术是近几年国外逐渐开始流行的牙型，如美国Biomet公司的Polaris5.5螺钉系统就采用了这种技术。这种牙型在矩形螺纹的基础上在螺牙的受力面上增加了一个倾斜的法兰（突起），当螺塞向下拧紧时，法兰上的斜面便会产生向内的拉力，避免了钉壁的张开。由于法兰的存在，螺牙和钉壁的过渡部位的牙厚度比普通矩形螺纹的厚度降低了，法兰越高，螺牙根部的厚度就越薄，这就在螺牙根部产生应力集中并降低螺牙的强度，当螺塞拧紧的扭矩足够大时，螺牙就会因为剪切应力过大而在根部断裂。所以螺旋法兰技术虽然解决了钉壁张开的问题，但由于削弱了螺牙本身的强度，螺钉的安全性和可靠性但是还不能得到很大的提高，在实际使用中还是存在螺牙断裂的风险而一直没有得到广泛的应用。
发明内容
本发明的目的是解决上述现有技术的不足，提供一种结构简单,锁紧效果佳，钉壁不易张开，螺牙不易断裂，安全性高的高强度骨螺钉座。
本发明解决上述现有技术的不足所采用的技术方案是：
一种高强度骨螺钉座，包括钉座主体和紧固螺塞，钉座主体内纵向设有装配孔，钉座主体上部设有用于穿设连接棒的U形槽，U形槽两侧的钉座主体内壁上设有内螺纹，紧固螺塞与内螺纹相配合的设在钉座主体上部内，其特征在于紧固螺塞上的外螺纹上侧面从牙顶至螺牙的牙高0.2-0.8倍处设有向上凸起的外挡块，钉座主体上部内侧的内螺纹下侧面从牙顶至螺牙的牙高0.8-0.2倍处设有向下凸起的与外挡块相配合的内挡块；钉座主体的轴向剖面中，钉座主体上部内侧的内螺纹上侧面的剖面线与钉座主体的轴线呈30°-75°夹角；紧固螺塞的轴向剖面中，紧固螺塞上的外螺纹下侧面的剖面线与紧固螺塞轴线呈30°-75°夹角。
本发明的钉座主体的轴向剖面中，所述钉座主体上部内侧的内螺纹下侧面的剖面线与钉座主体的轴线垂直，在紧固螺塞的轴向剖面中，所述紧固螺塞上的外螺纹上侧面的剖面线与紧固螺塞轴线垂直。当然，这些垂直的剖面线也可以和钉座或螺塞的轴线成一定的角度，如75-105度。
本发明中所述的紧固螺塞上的外螺纹上侧面从牙顶至螺牙的牙高约0.5倍处设有向上凸起的外挡块，螺钉座上部内侧的内螺纹下侧面从牙顶至螺牙的牙高约0.5倍处设有向下凸起的与外挡块相配合的内挡块；钉座主体的轴向剖面中，钉座主体上部内侧的内螺纹上侧面的剖面线与钉座主体的轴线呈45°夹角；紧固螺塞的轴向剖面中，紧固螺塞上的外螺纹下侧面的剖面线与紧固螺塞轴线呈45°夹角。本发明中所述的外挡块和内挡块的高度为螺距的0.03-0.2倍。
为了降低应力集中的情况，本发明中的内外螺纹的螺牙的剖面线轮廓应光滑过渡，避免各线段以尖角过渡，产生应力集中而降低螺纹的强度。本发明在使用时，当紧固螺塞的外螺纹与钉座主体上部的内螺纹相互啮合连接时，内挡块镶嵌在紧固螺塞外螺纹的外挡块与牙底之间的凹槽内，外挡块镶嵌在螺钉座上部的内螺纹的内挡块与牙底之间的凹槽内，当紧固螺塞拧紧时，螺钉座上部向外扩张的趋势被内外相互配合的内挡块和外挡块阻止，在内外螺纹的螺牙上应力分布均匀，螺牙根部强度高，内螺纹和外螺纹紧密贴合，压紧、锁定连接棒，锁定效果佳；内螺纹和外螺纹的牙底与钉座主体和紧固螺塞的连接部位牢固，同时避免了钉座的张开和螺牙的剪切破坏，使螺钉的安全性得到了很大的提高。
附图说明
图1是本发明的结构示意图。
图2是本发明中紧固螺塞的结构示意图。
图3是本发明中钉座主体的结构示意图。
图4是本发明安装螺钉后的结构示意图。
图5是本发明使用时紧固螺塞的螺牙受力分析图。
具体实施方式
如图1-3所示的高强度骨螺钉座，包括钉座主体1和紧固螺塞2，钉座主体1内纵向设有装配孔，钉座主体1上部设有用于穿设连接棒的U形槽，U形槽两侧的钉座主体1内壁上设有内螺纹，紧固螺塞2与内螺纹相配合的设在钉座主体上部内，紧固螺塞2上的外螺纹上侧面3从牙顶至螺牙的牙高0.2-0.8倍处设有向上凸起的外挡块4，钉座主体1上部内侧的内螺纹下侧面7从牙顶至螺牙的牙高0.8-0.2倍处设有向下凸起的与外挡块相配合的内挡块6；所述的外挡块和内挡块的高度为螺距的0.03-0.2倍。从图3中可以看出，钉座主体1的轴向剖面中，钉座主体1上部内侧的内螺纹上侧面8的剖面线由内至外向上倾斜、与钉座主体的轴线呈30°-75°的夹角；紧固螺塞的轴向剖面中，紧固螺塞上的外螺纹下侧面5的剖面线由内向外向上倾斜的、与紧固螺塞轴线呈30°-75°夹角。钉座主体的轴向剖面中，所述钉座主体上部内侧的内螺纹下侧面7的剖面线与钉座主体的轴线垂直或成一个75-105度的角度，在紧固螺塞的轴向剖面中，所述紧固螺塞上的外螺纹上侧面3的剖面线与紧固螺塞轴线垂直或成一个75-105度的角度。
本发明中所述的紧固螺塞上的外螺纹上侧面从牙顶至螺牙的牙高约0.5倍处设有向上凸起的外挡块，螺钉座上部内侧的内螺纹下侧面从牙顶至螺牙的牙高约0.5倍处设有向下凸起的与外挡块相配合的内挡块；钉座主体的轴向剖面中，钉座主体上部内侧的内螺纹上侧面的剖面线与钉座主体的轴线呈45°夹角；紧固螺塞的轴向剖面中，紧固螺塞上的外螺纹下侧面的剖面线与紧固螺塞轴线呈45°夹角。内螺纹与外螺纹为截面形状上下相反的相同螺纹。
为了降低应力集中的情况，本发明中的内外螺纹的螺牙的剖面线轮廓应光滑过渡，避免各线段以尖角过渡，产生应力集中而降低螺纹的强度。本发明在使用时，当紧固螺塞的外螺纹与钉座主体上部的内螺纹相互啮合连接时，内挡块镶嵌在紧固螺塞外螺纹的外挡块与牙底之间的凹槽内，外挡块镶嵌在螺钉座上部的内螺纹的内挡块与牙底之间的凹槽内，当紧固螺塞被拧紧时， 螺塞的螺牙受力如图5所示。螺牙的外挡块的表面和上侧面均受到了来自螺钉座的配合面的反作用力，这些反作用力的合力就是压在连接棒的锁紧力，而外挡块的侧面则受到了螺钉座的内挡块的侧面的反作用力，这个反作用力方向对螺塞来说向外的，而对螺钉座的钉壁来说是向内的拉力，从而避免了钉壁的张开。而螺牙的下表面由于大角度斜面的存在，使得螺牙根部的厚度大大增加，使应力集中的现象得以消除，而螺牙外侧由于应力较小，即使厚度较小，也不容易出现破坏，从而最大限度地利用了整个螺牙上材料的强度，使应力分布更加均匀，达到了既防止钉壁的张开，又防止螺牙的剪切破坏的目的，使螺钉的安全性得到了很大的提高。螺钉座的牙型和螺塞上的牙型是配对互补的，因此其应力分布和螺塞上的螺牙应力分布是相似的。采用了本发明的牙型后，螺纹的强度问题得到了根本性的解决，使一直困扰骨科医生的钉座张开和螺牙破坏的问题得以比较彻底的解决，使椎弓根螺钉这一骨科里广泛使用的植入物的安全性获得了很大的提高。
本发明同时解决了螺钉座钉壁张开和螺牙剪切破坏的问题，从而大大提高了螺钉座的强度，基本上杜绝了术中发生钉壁张开和螺纹破坏的情况，使椎弓根螺钉的安全性和可靠性得到了根本性的提高。

Claims (4)

1.一种高强度骨螺钉座，包括钉座主体和紧固螺塞，钉座主体内纵向设有装配孔，钉座主体上部设有用于穿设连接棒的U形槽，U形槽两侧的钉座主体内壁上设有内螺纹，紧固螺塞与内螺纹相配合的设在钉座主体上部内，其特征在于紧固螺塞上的外螺纹上侧面从牙顶至螺牙的牙高0.2-0.8倍处设有向上凸起的外挡块，钉座主体上部内侧的内螺纹下侧面从牙顶至螺牙的牙高0.8-0.2倍处设有向下凸起的与外挡块相配合的内挡块；钉座主体的轴向剖面中，钉座主体上部内侧的内螺纹上侧面的剖面线与钉座主体的轴线呈30°-75°夹角；紧固螺塞的轴向剖面中，紧固螺塞上的外螺纹下侧面的剖面线与紧固螺塞轴线呈30°-75°夹角。
2.根据权利要求1所述的高强度骨螺钉座，其特征在于所述的外挡块和内挡块的高度为螺距的0.03-0.4倍。
3.根据权利要求1或2所述的高强度骨螺钉座，其特征在于在的钉座主体的轴向剖面中，所述钉座主体上部内侧的内螺纹下侧面的剖面线与钉座主体的轴线垂直，在紧固螺塞的轴向剖面中，所述紧固螺塞上的外螺纹上侧面的剖面线与紧固螺塞轴线垂直或成一个约为75-105度的夹角。
4.根据权利要求3所述的高强度骨螺钉座，其特征在于所述的紧固螺塞上的外螺纹上侧面从牙顶至螺牙的牙高约0.5倍处设有向上凸起的外挡块，螺钉座上部内侧的内螺纹下侧面从牙顶至螺牙的牙高约0.5倍处设有向下凸起的与外挡块相配合的内挡块；钉座主体的轴向剖面中，钉座主体上部内侧的内螺纹上侧面的剖面线与钉座主体的轴线呈45°夹角；紧固螺塞的轴向剖面中，紧固螺塞上的外螺纹下侧面的剖面线与紧固螺塞轴线呈45°夹角。
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