CN106344137A - 胸腰椎后路柔性固定系统 - Google Patents

胸腰椎后路柔性固定系统 Download PDF

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CN106344137A
CN106344137A CN201510428252.9A CN201510428252A CN106344137A CN 106344137 A CN106344137 A CN 106344137A CN 201510428252 A CN201510428252 A CN 201510428252A CN 106344137 A CN106344137 A CN 106344137A
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spring rod
thoracic
pedicle screw
fixed system
jackscrew
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颜云辉
刘闯
宋克臣
董志鹏
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Northeastern University China
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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
    • 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
    • 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
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7031—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other made wholly or partly of flexible material
    • 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
    • A61B17/7049—Connectors, not bearing on the vertebrae, for linking longitudinal elements together
    • A61B17/7052—Connectors, not bearing on the vertebrae, for linking longitudinal elements together of variable angle or length
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • 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
    • A61B2017/564—Methods for bone or joint treatment

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
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Abstract

本发明涉及骨科用医疗器械领域，尤其是一种胸腰椎病变或损伤时，用于对胸腰椎进行固定的胸腰椎后路柔性固定系统。该系统包括两个椎弓根螺钉、一个起柔性连接两个椎弓根螺钉作用的Ni-Ti弹簧棒及用于锁紧固定Ni-Ti弹簧棒和椎弓根螺钉的顶丝。Ni-Ti弹簧棒规格为：丝径2.24～2.99mm，中径5mm。本发明的胸腰椎后路柔性固定系统针对目前主流的坚强固定系统存在的术后并发症问题，结合人体生物力学相关理论，是从力学角度提出的重建人体腰椎稳定的解决方案。该系统所有设计参数直接来自国人脊柱解剖学数据，可满足胸腰椎内固定手术需求，固定及恢复效果良好。

Description

胸腰椎后路柔性固定系统
技术领域
本发明涉及骨科用医疗器械领域，尤其是一种胸腰椎病变或损伤时，用于对胸腰椎进行固定的胸腰椎后路柔性固定系统。
背景技术
腰椎融合手术是治疗由关节退变、椎间盘突出等各种疾病引发的腰椎不稳的通用手术，手术的关键是要植入内固定器械保证病变腰椎的稳定性，从而给予植骨融合必要的条件。其使用的内固定器械属于坚强系统，植入腰椎后，会使得被植入节段活动度过分限制，从而导致相邻节段退变以及植骨融合不可靠甚至失败，同时还可能因为内部应力集中过大而导致系统失效，出现松动、脱钉等现象。
在这种情况下，柔性内固定系统的需求应运而生。在最近的30年内，世界各国学者都不断的在研究柔性内固定系统，但是到目前为止，较成熟应用于市场的柔性内固定系统并不多，主要代表有两个，分别是Dynesys系统和Graf韧带系统。但是由多位学者的调查研究发现，Dynesys系统和Graf韧带系统都存在着比较严重的缺陷。因此，为了满足市场需要，有必要设计一种结构简单可靠的胸腰椎后路柔性固定系统。
发明内容
本发明针对现有产品的缺陷，提供了一种结构简单可靠，力学性能优越，使用方便，且适用于腰椎退变或融合手术恢复期，稳定性好的胸腰椎后路柔性固定系统。
本发明的技术方案是：
一种胸腰椎后路柔性固定系统，该系统包括两个椎弓根螺钉、一个起柔性连接两个椎弓根螺钉作用的Ni-Ti弹簧棒及用于锁紧固定Ni-Ti弹簧棒和椎弓根螺钉的顶丝。
所述的胸腰椎后路柔性固定系统，Ni-Ti弹簧棒的结构中间部分为两圈弹簧，Ni-Ti弹簧棒的结构两端部分为直棒，Ni-Ti弹簧棒通过直棒与椎弓根螺钉固定连接。
所述的胸腰椎后路柔性固定系统，椎弓根螺钉的外螺纹部分为锥形结构，椎弓根螺钉尾部开有U型槽，椎弓根螺钉通过U型槽与Ni-Ti弹簧棒固定连接，椎弓根螺钉与Ni-Ti弹簧棒为柱面接触。
所述的胸腰椎后路柔性固定系统，锥度范围为1～3度。
所述的胸腰椎后路柔性固定系统，椎弓根螺钉尾部设有内螺纹部分，内螺纹部分安装顶丝，通过顶丝固定Ni-Ti弹簧棒。
所述的胸腰椎后路柔性固定系统，Ni-Ti弹簧棒规格为：丝径2.24～2.99mm，中径5mm。
所述的胸腰椎后路柔性固定系统，椎弓根螺钉为钛合金材质椎弓根螺钉，顶丝为钛合金材质顶丝。
与现有技术相比，本发明具有如下有益效果：
1、本发明提供的胸腰椎后路柔性固定系统由椎弓根螺钉、连接椎弓根螺钉的Ni-Ti弹簧棒以及锁紧顶丝组成，锁紧顶丝用于固定Ni-Ti弹簧棒，其结构简单，可靠性高；
2、本发明Ni-Ti弹簧棒的中间部分为两圈弹簧，Ni-Ti弹簧棒的两端部分为直棒，中间部分的两圈弹簧在脊椎进行弯曲等生理运动下受力可以产生弹性变形，维持脊椎正常的活动。椎弓根螺钉采用锥形螺钉，可有效地提高了螺钉根部薄弱部位的强度；
3、本发明的金属柔性系统力学性能优越，与人体组织生物相容性好；
4、本发明符合人体脊椎运动原理，有助于脊柱正常功能的恢复。
附图说明
图1为根据本发明一实施例的胸腰椎后路柔性固定系统结构简图；
图2为根据本发明一实施例的胸腰椎后路柔性固定系统的Ni-Ti弹簧棒示意图；
图3为根据本发明一实施例的胸腰椎后路柔性固定系统的椎弓根螺钉示意图；
图4(a)-(b)为根据本发明一实施例的胸腰椎后路柔性固定系统的顶丝示意图。其中，图4(a)为俯视图；图4(b)为主视图。
图中，1、弹簧棒；2、椎弓根螺钉；3、顶丝；4、直棒；5、弹簧；6、U型槽；7、内螺纹部分；8、外螺纹部分。
具体实施方式
下面结合附图对本发明进一步详细阐述。
参见图1、图2、图3、图4(a)-(b)，本发明胸腰椎后路柔性固定系统，包括两个椎弓根螺钉2、一个起柔性连接两个椎弓根螺钉2作用的Ni-Ti弹簧棒1及用于锁紧固定Ni-Ti弹簧棒1和椎弓根螺钉2的顶丝3。
如图2所示，Ni-Ti弹簧棒1的结构中间部分为两圈弹簧5，弹簧5使Ni-Ti弹簧棒1具有一定的柔性，可满足胸腰椎正常生理活动需求，Ni-Ti弹簧棒1的结构两端部分为直棒4，直棒4可与椎弓根螺钉2方便固定连接。
如图3、图4(a)-(b)所示，椎弓根螺钉2的外螺纹部分8设计成锥形(锥度范围为1～3度)，可有效地提高椎弓根螺钉2根部的强度，椎弓根螺钉2根部一直是整个系统应力集中的部位，这种设计可以降低椎弓根螺钉2从根部断裂的风险。椎弓根螺钉2尾部开有一个U型槽6，椎弓根螺钉2通过U型槽6与Ni-Ti弹簧棒1固定连接，椎弓根螺钉2与Ni-Ti弹簧棒1为柱面接触牢固可靠。椎弓根螺钉2尾部的内螺纹部分7用于拧入顶丝3，通过顶丝3固定Ni-Ti弹簧棒1。
在进行胸腰椎后路柔性固定系统植入时，先确定患者脊椎的患病节段，根据需求植入椎弓根螺钉2，然后选择合适尺寸Ni-Ti弹簧棒1安置于椎弓根螺钉2的U型槽6内，最后拧入顶丝3，植入过程安全快捷。
根据本发明的一优选实施例，Ni-Ti弹簧棒是NTS系统的关键组件，由镍(50.8～51.8wt％)和余量的钛合成。参照相关力学实验数据，Ni-Ti弹簧棒规格为丝径2.24～2.99mm，中径5mm。该尺寸Ni-Ti弹簧棒的刚度与人体正常的生理载荷相匹配，可避免脊椎组织损伤和固定装置的破坏。Ni-Ti弹簧棒长度和椎弓根螺钉的长度及直径可根据病人个体化差异定制。另外，椎弓根螺钉及顶丝为钛合金材质。
实施例结果表明，本发明的胸腰椎后路柔性固定系统针对目前主流的坚强固定系统存在的术后并发症问题，结合人体生物力学相关理论，是从力学角度提出的重建人体腰椎稳定的解决方案。该系统充分考虑了国人的解剖学特点，所有设计参数直接来自国人脊柱解剖学数据，可满足胸腰椎内固定手术需求，固定及恢复效果良好。

Claims (7)

1.一种胸腰椎后路柔性固定系统，其特征在于，该系统包括两个椎弓根螺钉、一个起柔性连接两个椎弓根螺钉作用的Ni-Ti弹簧棒及用于锁紧固定Ni-Ti弹簧棒和椎弓根螺钉的顶丝。
2.根据权利要求1所述的胸腰椎后路柔性固定系统，其特征在于，Ni-Ti弹簧棒的结构中间部分为两圈弹簧，Ni-Ti弹簧棒的结构两端部分为直棒，Ni-Ti弹簧棒通过直棒与椎弓根螺钉固定连接。
3.根据权利要求1所述的胸腰椎后路柔性固定系统，其特征在于，椎弓根螺钉的外螺纹部分为锥形结构，椎弓根螺钉尾部开有U型槽，椎弓根螺钉通过U型槽与Ni-Ti弹簧棒固定连接，椎弓根螺钉与Ni-Ti弹簧棒为柱面接触。
4.根据权利要求3所述的胸腰椎后路柔性固定系统，其特征在于，锥度范围为1～3度。
5.根据权利要求1或3所述的胸腰椎后路柔性固定系统，其特征在于，椎弓根螺钉尾部设有内螺纹部分，内螺纹部分安装顶丝，通过顶丝固定Ni-Ti弹簧棒。
6.根据权利要求1所述的胸腰椎后路柔性固定系统，其特征在于，Ni-Ti弹簧棒规格为：丝径2.24～2.99mm，中径5mm。
7.根据权利要求1所述的胸腰椎后路柔性固定系统，其特征在于，椎弓根螺钉为钛合金材质椎弓根螺钉，顶丝为钛合金材质顶丝。
CN201510428252.9A 2015-07-21 2015-07-21 胸腰椎后路柔性固定系统 Pending CN106344137A (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112716583A (zh) * 2021-01-20 2021-04-30 迪恩医疗科技有限公司 颈椎后路系统弹性连接棒

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US20070112427A1 (en) * 2005-11-16 2007-05-17 Aoi Medical, Inc. Intervertebral Spacer
CN101816587A (zh) * 2010-04-19 2010-09-01 天津正天医疗器械有限公司 一种脊柱内固定万向椎弓根螺钉
CN202537635U (zh) * 2012-05-11 2012-11-21 温州医学院附属第一医院 一种腰椎椎板间动态连接装置
CN203506856U (zh) * 2013-10-14 2014-04-02 中国人民解放军总医院第一附属医院 腰椎后路动态内固定系统
CN204814138U (zh) * 2015-07-21 2015-12-02 东北大学 胸腰椎后路柔性固定系统

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070112427A1 (en) * 2005-11-16 2007-05-17 Aoi Medical, Inc. Intervertebral Spacer
CN101816587A (zh) * 2010-04-19 2010-09-01 天津正天医疗器械有限公司 一种脊柱内固定万向椎弓根螺钉
CN202537635U (zh) * 2012-05-11 2012-11-21 温州医学院附属第一医院 一种腰椎椎板间动态连接装置
CN203506856U (zh) * 2013-10-14 2014-04-02 中国人民解放军总医院第一附属医院 腰椎后路动态内固定系统
CN204814138U (zh) * 2015-07-21 2015-12-02 东北大学 胸腰椎后路柔性固定系统

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112716583A (zh) * 2021-01-20 2021-04-30 迪恩医疗科技有限公司 颈椎后路系统弹性连接棒

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Application publication date: 20170125