WO2016054951A1 - 一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件 - Google Patents

一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件 Download PDF

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WO2016054951A1
WO2016054951A1 PCT/CN2015/087622 CN2015087622W WO2016054951A1 WO 2016054951 A1 WO2016054951 A1 WO 2016054951A1 CN 2015087622 W CN2015087622 W CN 2015087622W WO 2016054951 A1 WO2016054951 A1 WO 2016054951A1
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threaded
support body
pedicle screw
pull
screw assembly
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PCT/CN2015/087622
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English (en)
French (fr)
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王海强
马驰蛟
李新奎
裴延军
吴智钢
刘旭
车路
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中国人民解放军第四军医大学
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Publication of WO2016054951A1 publication Critical patent/WO2016054951A1/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
    • A61B17/84—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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant

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  • the invention belongs to the field of medical auxiliary devices, and particularly relates to a medical retractable double-threaded, anti-extracting pedicle screw assembly.
  • the object of the present invention is to overcome the disadvantages of the prior art described above, and to provide a medical retractable double-threaded, pull-out pedicle screw assembly, which has a firm fixation and can improve the holding force and the pull-out resistance of the screw. advantage.
  • a hollow nail body is provided, and a tail end of the nail body is fixed with a nail tail;
  • a hollow threaded control shaft is disposed in the hollow body of the nail body, and the thread control shaft is provided with a rotary groove One end runs through the tail of the nail;
  • the outer wall of the nail body is fixed with a plurality of fixing threads, and a plurality of holes are formed in the outer wall of the front end of the nail body, and a plurality of retractable screws are arranged in the hole, and a connecting rod is fixed at the bottom of the telescopic screw, and one end of the connecting rod is disposed at Thread control shaft;
  • the threaded control shaft has a butterfly structure in a cross section, and includes a middle shaft and a first support body and a second support body symmetrically disposed along a center line of the middle shaft; the inner sides of the first support body and the second support body are fixed On the central axis, two outer sides of the first support body and the second support body are fixed with a sliding piece matched with the connecting rod;
  • the sliding piece has a crescent shape in cross section, and the two sliding pieces are oppositely disposed.
  • the nail tail is in the shape of a bowl, and an inner thread is arranged on the inner wall thereof.
  • the lengths of the two oblique sides of the first support body and the second support body are equal, and the angle of the bottom angle is 45°.
  • the material of the thread control shaft, the connecting rod and the tail is medical titanium alloy.
  • the diameter of the threaded control shaft is smaller than the diameter of the hollow body.
  • the height of the fixing thread is 0.8 to 1.2 mm.
  • the length of the retractable screw is 1.5 to 2.5 mm.
  • the hollow nail body has an outer diameter of 6 to 7 mm.
  • the inner hollow body has an inner diameter of 2.5 to 3.5 mm.
  • the bottom of the connecting rod is fixed with a second sliding piece that cooperates with the first sliding piece.
  • the present invention has the following beneficial effects: Compared with the prior art, the present invention provides a threaded control shaft in the hollow cavity of the nail body, and the threaded control shaft cooperates with the connecting rod, the connecting rod is connected with the retractable screw, and the retractable screw is set.
  • the cross section of the threaded control shaft has a butterfly structure, and includes a middle shaft and a first support body and a second support body symmetrically disposed along a center line of the middle shaft;
  • the outer side of the support body and the second support body are fixed with two sliding pieces matched with the connecting rod;
  • the cross section of the sliding piece is crescent-shaped, and the two sliding pieces are oppositely arranged; thereby the shaft can be adjusted by rotating the thread, and the adjustment can be
  • the rise and fall of the telescopic screw is extremely convenient to use.
  • the rotation of the thread is controlled by rotating the thread control shaft to improve the stability of the spinal fixation during osteoporosis or revision of the secondary nail, and to reduce the incidence of loosening or even prolapse.
  • the retractable screw can be retracted by rotating the thread control shaft to achieve a perfect combination of pull-out and retraction. Reduce the risk of pedicle screw loosening and pulling out.
  • the design of the retractable screw also ensures that the pedicle screw can be removed under special circumstances, effectively improving the clinical efficacy.
  • the nail tail is in the shape of a bowl, the inner wall is provided with internal threads, thereby reducing the difficulty of the user's operation on the nail body, and making the doctor more convenient to use.
  • Figure 2 is a schematic view showing the structure of the threaded control shaft in the retracted original state of the present invention.
  • Figure 3 is a schematic view showing the structure of the threaded control shaft when the present invention is in the extended state.
  • the present invention includes a hollow nail body 1 having a tail portion 5 fixed to the tail portion of the nail body 1; a hollow threaded control shaft 3 is disposed in the hollow cavity body 6 of the nail body 1, and the thread control shaft 3 is provided.
  • One end of the rotating groove is inserted through the outer end of the nail 5; a fixed thread 7 is fixed on the outer wall of the nail body 1.
  • a plurality of holes are formed in the outer wall of the front end of the nail body 1, and a plurality of retractable screws 8 are provided in the hole, and the retractable screw is provided.
  • the bottom of the 8 is fixed with a connecting rod 4, one end of the connecting rod 4 is disposed in the threaded control shaft 3;
  • the threaded control shaft 3 has a butterfly-shaped cross section, and includes a middle shaft 2 and a line symmetrically disposed along the center line 2 thereof.
  • a support body 9 and a second support body 10 the inner sides of the first support body 9 and the second support body 10 are both fixed to the central shaft 2, and the outer sides of the first support body 9 and the second support body 10 are fixed at two
  • the sliding piece 12 cooperates with the connecting rod 4; the sliding piece 12 has a crescent shape in cross section, and the two sliding pieces 12 are oppositely disposed.
  • the nail tail 5 has a U-shaped cross section and is provided with an internal thread 11 on its inner wall.
  • the lengths of the two oblique sides of the first support body 9 and the second support body 10 are equal, and the angle of the bottom angle is 45°, and the materials of the thread control shaft 3, the connecting rod 4 and the nail tail 5 are all medical titanium alloys.
  • the diameter of the threaded control shaft 3 is smaller than the diameter of the hollow body 6.
  • the height of the fixing thread 7 is 0.8 to 1.2 mm.
  • the retractable screw 8 has a length of 1.5 to 2.5 mm.
  • the outer diameter of the hollow nail body 1 is 6 to 7 mm.
  • the inner diameter of the hollow body 6 is 2.5 to 3.5 mm.
  • the bottom of the connecting rod 4 is fixed with a second sliding piece 13 that cooperates with the first sliding piece 12.
  • the pedicle screw assembly can be used to ensure that the double thread height is consistent and the retractable screw 8 is in the original position.
  • the telescopic pusher is used to control the extension of the retractable screw 8 in the pedicle screw by rotating the screw shaft of the opening of the nail to control the central axis 2 in the shaft 3, thereby realizing the improvement of the screw Bone grip. If the pedicle screw needs to be removed, the snail is realized by rotating the thread to control the central shaft 2 in the shaft 3. The retraction of the retractable screw 8 in the nail enables smooth removal.
  • the central shaft 2 in the shaft 3 is controlled by rotating the screw, and since the inner sides of the first support body 9 and the second support body 10 are fixed to the center shaft 2, the first support body 9 is driven by the rotation of the center shaft 2 and The second support body 10 rotates together, and the two side walls of the first support body 9 and the second support body 10 are pressed and connected with the connecting rod 4 of the retractable screw 8 to raise the retractable screw 8 and extend the thread control shaft 3
  • one end of the connecting rod 4 to which the second sliding piece 13 is fixed is engaged in the two first sliding pieces 12 constituting the butterfly structure, and the butterfly structure positions the retractable screw 8 to avoid sliding thereof. It is fixed and stable; the deep thread can increase the contact area with the bone, and improve the holding force and pull-out force of the screw.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，通过在钉体（1）的中空腔体（6）内设置螺纹控制轴（3），且螺纹控制轴（3）与连接杆（4）相配合，连接杆（4）连接可伸缩螺钉（8），可伸缩螺钉（8）设置于钉体（1）前端外壁上开设有若干孔洞中，且由于螺纹控制轴（3）的横截面呈蝶形结构，包括中轴（2）和其上沿中轴（2）中线对称设置的第一支撑体（9）和第二支撑体（10）；第一支撑体（9）和第二支撑体（10）的外侧均固定有两个与连接杆（4）相配合的第一滑片（12）；第一滑片（12）的横截面呈月牙形，且两个第一滑片（12）相对设置；从而能够通过旋转螺纹控制轴（3），调节可伸缩螺钉（8）的上升与下降，通过旋转螺纹控制轴（3）实现螺纹的旋出，提高骨质疏松或翻修二次置钉时脊柱内固定稳定性，减少松动甚至脱出的发生率。

Description

一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件 技术领域
本发明属于医疗辅助器械领域，具体涉及一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件。
背景技术
脊柱融合术为治疗脊柱很多种类疾病的主要治疗方法之一，美国脊柱融合手术例数逐年递增，1998年到2008年，每10万人口中，颈椎、胸椎、腰椎融合例数分别增长了90％，61％和141％(Rajaee SS,Bae HW,Kanim LE,Delamarter RB.Spinal fusion in the United States:analysis of trends from 1998to 2008.Spine(Phila Pa 1976)2012；37(1):67-76)。脊柱融合术多采用后路椎弓根螺钉+固定棒—钉棒***实现，但随着人口老龄化及由此带来的骨质疏松发病率的提高，以及由于椎弓根螺钉松动而导致脊柱融合失败而需翻修手术的增多(Rajaee SS,Kanim LEA,Bae HW.National trends in revision spinal fusion in the USA:Patient characteristics and complications.Bone Joint J 2014；96B(6):807-16)，传统的椎弓根螺钉固定技术受到极大的挑战。对于骨质疏松和翻修时二次置钉的椎体，传统的椎弓根螺钉固定易于松动，而难以要实现牢靠固定；近年来国内外学者进行了种种探索与改进，包括钉鞘、膨胀式螺钉组件、可注射螺钉组件等，虽然也能实现骨质疏松和翻修椎体椎弓根钉的固定，但膨胀或注射后螺钉组件的改变为不可逆性。一旦椎弓根螺钉出现问题，需取出内固定，这些改进无法实现顺利取出。
生物力学研究表明，椎弓根螺钉与骨界面的把持力，与接触的面积及深度 成正比。深的螺纹可增大与骨质的接触面积，提高螺钉的把持力及抗拔出力。目前常用的椎弓根螺钉的螺纹深度为1mm。
发明内容
本发明的目的在于克服上述现有技术中存在的缺点，提供一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，具有固定牢固，能够提高螺钉的把持力及抗拔出力的优点。
为实现上述目的，本发明采用以下技术方案：包括中空的钉体，钉体的尾部固定有钉尾；钉体的中空腔体内设置有能够旋转的螺纹控制轴，且螺纹控制轴开设有旋转槽的一端贯穿钉尾外；
所述的钉体的外壁上固定有若干固定螺纹，钉体前端外壁上开设有若干孔洞，孔洞中均设置有若干可伸缩螺钉，可伸缩螺钉的底部固定有连接杆，连接杆的一端设置于螺纹控制轴内；
所述的螺纹控制轴的横截面呈蝶形结构，包括中轴和其上沿中轴中线对称设置的第一支撑体和第二支撑体；第一支撑体和第二支撑体的内侧均固定于中轴上，第一支撑体和第二支撑体的外侧均固定有两个与连接杆相配合的滑片；
所述的滑片的横截面呈月牙形，且两个滑片相对设置。
所述的钉尾呈碗状，且其内壁上设置有内螺纹。
所述的第一支撑体和第二支撑体的两斜边长度相等，且底角的角度均为45°。
所述的螺纹控制轴、连接杆和钉尾的材料均为医用钛合金。
所述的螺纹控制轴的直径小于中空腔体的直径。
所述的固定螺纹的高度为0.8～1.2mm。
所述的可伸缩螺钉长度为1.5～2.5mm。
所述的中空钉体的外径为6～7mm。
所述的中空腔体的内径为2.5～3.5mm。
所述的连接杆的底部，固定有与第一滑片相配合的第二滑片。
本发明具有以下的有益效果：相比较现有技术，本发明通过在钉体的中空腔体内设置螺纹控制轴，且螺纹控制轴与连接杆相配合，连接杆连接可伸缩螺钉，可伸缩螺钉设置于钉体前端外壁上开设有若干孔洞中，且由于螺纹控制轴的横截面呈蝶形结构，包括中轴和其上沿中轴中线对称设置的第一支撑体和第二支撑体；第一支撑体和第二支撑体的外侧均固定有两个与连接杆相配合的滑片；滑片的横截面呈月牙形，且两个滑片相对设置；从而能够通过旋转螺纹控制轴，调节可伸缩螺钉的上升与下降，极大的方便了使用。通过旋转螺纹控制轴实现螺纹的旋出，提高骨质疏松或翻修二次置钉时脊柱内固定稳定性，减少松动甚至脱出的发生率。特殊情况需取出内固定时，通过旋转螺纹控制轴使可伸缩螺钉收回，实现抗拔出和可取出的完美结合。降低椎弓根螺钉松动、拔出的风险，同时，可伸缩螺钉设计，也保证了特殊情况下椎弓根螺钉可取出，有效的改善临床疗效。
进一步的，由于钉尾呈碗状，内壁上设置有内螺纹，从而降低使用者对钉体的操作难度，使得医生使用更加方便。
附图说明
图1是本发明整体结构示意图。
图2是本发明处于缩回原始状态时螺纹控制轴结构示意图。
图3是本发明处于伸出状态时螺纹控制轴结构示意图。
具体实施方式
下面结合附图，对本发明作进一步详细说明。
参见图1-3，本发明包括中空的钉体1，钉体1的尾部固定有钉尾5；钉体1的中空腔体6内设置有能够旋转的螺纹控制轴3，且螺纹控制轴3开设有旋转槽的一端贯穿钉尾5外；钉体1的外壁上固定有若干固定螺纹7，钉体1前端外壁上开设有若干孔洞，孔洞中均设置有若干可伸缩螺钉8，可伸缩螺钉8的底部固定有连接杆4，连接杆4的一端设置于螺纹控制轴3内；螺纹控制轴3的横截面呈蝶形结构，包括中轴2和其上沿中轴2中线对称设置的第一支撑体9和第二支撑体10；第一支撑体9和第二支撑体10的内侧均固定于中轴2上，第一支撑体9和第二支撑体10的外侧均固定有两个与连接杆4相配合的滑片12；滑片12的横截面呈月牙形，且两个滑片12相对设置。钉尾5的横截面呈U型，且其内壁上设置有内螺纹11。第一支撑体9和第二支撑体10的两斜边长度相等，且底角的角度均为45°，螺纹控制轴3、连接杆4和钉尾5的材料均为医用钛合金。螺纹控制轴3的直径小于中空腔体6的直径。固定螺纹7的高度为0.8～1.2mm。可伸缩螺钉8长度为1.5～2.5mm。中空钉体1的外径为6～7mm。中空腔体6的内径为2.5～3.5mm。所述的连接杆4的底部，固定有与第一滑片12相配合的第二滑片13。
使用方法：在脊柱外科手术时，于椎弓根处准确建立椎弓根螺钉钉道后，即可使用本椎弓根螺钉组件，确保双螺纹高度一致，及可伸缩螺钉8处于原始位置时，常规植入椎弓根钉之后，采用转芯推进器，通过旋转钉尾开口的螺纹控制轴3内的中轴2，即可实现椎弓根螺钉中可伸缩螺钉8的伸出，实现提高螺钉的骨把持力。若需取出椎弓根螺钉，则通过旋转螺纹控制轴3内的中轴2，实现螺 钉中可伸缩螺钉8的缩回，实现顺利取出。
在使用时：
伸出状态：通过旋转螺纹控制轴3内的中轴2，且由于第一支撑体9和第二支撑体10的内侧固定于中轴2上，中轴2旋转时带动第一支撑体9和第二支撑体10一同转动，第一支撑体9和第二支撑体10的两个侧壁挤压连接有可伸缩螺钉8的连接杆4，使可伸缩螺钉8上升，伸出螺纹控制轴3外；转动90°后连接杆4的固定有第二滑片13的一端卡合在两个组成蝶形结构的第一滑片12内，蝶形结构对可伸缩螺钉8进行定位，避免其滑动，使其固定稳固；深的螺纹可增大与骨质的接触面积，提高螺钉的把持力及抗拔出力。
缩进状态：旋转中轴2，旋转角度为90°，由于骨对可伸缩螺钉8有压力，可伸缩螺钉8在失去了第一支撑体9和第二支撑体10的支撑后，骨可伸缩螺钉8的压力使其缩入螺纹控制轴3内，从而大幅减小了把持力，这时，能够轻松从骨内拆除装置。

Claims (10)

  1. 一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：包括中空的钉体(1)，钉体(1)的尾部固定有钉尾(5)；钉体(1)的中空腔体(6)内设置有能够旋转的螺纹控制轴(3)，且螺纹控制轴(3)开设有旋转槽的一端贯穿钉尾(5)外；
    所述的钉体(1)的外壁上固定有若干固定螺纹(7)，钉体(1)前端外壁上开设有若干孔洞，孔洞中均设置有若干可伸缩螺钉(8)，可伸缩螺钉(8)的底部固定有连接杆(4)，连接杆(4)的一端设置于螺纹控制轴(3)内；
    所述的螺纹控制轴(3)的横截面呈蝶形结构，包括中轴(2)和其上沿中轴(2)中线对称设置的第一支撑体(9)和第二支撑体(10)；第一支撑体(9)和第二支撑体(10)的内侧均固定于中轴(2)上，第一支撑体(9)和第二支撑体(10)的外侧均固定有两个与连接杆(4)相配合的第一滑片(12)；
    所述的滑片(12)的横截面呈月牙形，且两个第一滑片(12)相对设置。
  2. 根据权利要求1所述的一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：所述的钉尾(5)呈碗状，且其内壁上设置有内螺纹(11)。
  3. 根据权利要求1所述的一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：所述的第一支撑体(9)和第二支撑体(10)的两斜边长度相等，且底角的角度均为45°。
  4. 根据权利要求1所述的一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：所述的螺纹控制轴(3)、连接杆(4)和钉尾(5)的材料均为医用钛合金。
  5. 根据权利要求1所述的一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：所述的螺纹控制轴(3)的直径小于中空腔体(6)的直径。
  6. 根据权利要求1所述的一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：所述的固定螺纹(7)的高度为0.8～1.2mm。
  7. 根据权利要求1所述的一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：所述的可伸缩螺钉(8)长度为1.5～2.5mm。
  8. 根据权利要求1所述的一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：所述的中空钉体(1)的外径为6～7mm。
  9. 根据权利要求1所述的一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：所述的中空腔体(6)的内径为2.5～3.5mm。
  10. 根据权利要求1所述的一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件，其特征在于：所述的连接杆(4)的底部，固定有与第一滑片(12)相配合的第二滑片(13)。
PCT/CN2015/087622 2014-10-09 2015-08-20 一种医用可伸缩双螺纹、抗拔出的椎弓根螺钉组件 WO2016054951A1 (zh)

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