WO2023109432A1 - 一种颅骨钉和脑部电极固定组件 - Google Patents

一种颅骨钉和脑部电极固定组件 Download PDF

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WO2023109432A1
WO2023109432A1 PCT/CN2022/132975 CN2022132975W WO2023109432A1 WO 2023109432 A1 WO2023109432 A1 WO 2023109432A1 CN 2022132975 W CN2022132975 W CN 2022132975W WO 2023109432 A1 WO2023109432 A1 WO 2023109432A1
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skull
connecting part
nail
thread
connecting portion
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PCT/CN2022/132975
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English (en)
French (fr)
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王冠宇
尹明三
王浩
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苏州景昱医疗器械有限公司
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Publication of WO2023109432A1 publication Critical patent/WO2023109432A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation

Definitions

  • the present application relates to the technical field of skull fixation components, for example, to a skull nail and brain electrode fixation component.
  • the human brain is the most important part of the body.
  • the brain can direct and coordinate other parts of the body to make corresponding actions. But the brain, like the rest of the body, is not always healthy.
  • stimulation therapy can be performed in the form of implanted electrodes.
  • the auxiliary tools for fixing the electrodes usually need to be fixed on the skull.
  • the front end of the related common skull nails has weak strength and is easy to break when used.
  • the present application provides a skull nail and brain electrode fixation assembly to solve the above problems.
  • a skull nail has opposite front and rear ends, the skull nail includes: a screw rod and a screw head, the screw rod is connected to the screw head;
  • the screw rod In the extension direction from the front end of the skull nail to the rear end, the screw rod is divided into: a first connection part, a second connection part and a third connection part, and the threads on the first connection part and the second connection part connected, the thread on the second connecting part and the third connecting part are connected, the threads on the first connecting part and the second connecting part are taper threads, and the taper angle of the first connecting part is 80 -100 degrees, in the extension direction from the front end of the skull nail to the rear end, the diameters of the threads on the first connecting part and the second connecting part gradually increase.
  • the taper angle of the second connecting portion is 35-50 degrees.
  • the taper angle of the first connection part is 90 degrees
  • the taper angle of the second connection part is 43 degrees
  • the thread on the first connection part is a thread formed on the outer peripheral surface of the cone
  • the thread on the second connecting part is a thread formed on the conical pedestal
  • the top of the conical pedestal of the second connecting part is connected to the first connecting part
  • the bottom of the truncated cone of the second connection part is connected to one end of the third connection part.
  • the third connecting portion is provided with a thread, and the diameter and pitch of the thread of the third connecting portion remain constant in the extending direction from the front end to the rear end of the skull screw.
  • the cross-sectional shape of the threads on the first connecting portion is trapezoidal
  • the cross-sectional shape of the threads on the second connecting portion is trapezoidal
  • the cross-sectional shape of the threads on the third connecting portion is trapezoidal
  • the hardness of the cranial pin is ⁇ 260HV10, and the cranial pin is a titanium cranial pin.
  • the screw head is provided with a groove for matching with a screwdriver.
  • a brain electrode fixation assembly comprising:
  • a skull ring, threaded holes are provided on the skull ring;
  • Skull pins for passing through threaded holes in the skull ring and attaching to the skull.
  • the brain electrode fixation assembly further includes a cranial hole electrode lock and a cranial hole cover, and a through hole is set inside the skull ring, and the cranial hole electrode lock is used to be arranged in the through hole of the skull ring Inside, the cranial hole cover is connected with the skull ring and is used to seal the cranial hole electrode lock in the through hole of the skull ring.
  • two threaded holes are provided on the skull ring, and a skull nail is provided in each threaded hole.
  • the beneficial effects of the present application at least include:
  • the skull nail is designed to have a structure with a first connecting portion and a second connecting portion.
  • the design of the cone angle of the first connecting portion can ensure the strength and self-tapping of the skull nail, and the cone angle of the second connecting portion can ensure Good self-tapping property, so that the skull nail can be stably screwed into the skull, and the auxiliary component of the fixed electrode can be fixed more stably.
  • Fig. 1 is the structural representation of the skull titanium nail of the embodiment of the present application
  • Fig. 2 is a schematic diagram of the cooperation of the skull nail and the skull ring of the embodiment of the present application;
  • Fig. 3 is a schematic structural diagram of a skull nail and brain electrode fixation assembly according to an embodiment of the present application.
  • skull nail 11, first connecting part; 12, second connecting part; 13, third connecting part; 14, screw head; 2, skull ring; 21, threaded hole; 3, electrode lock.
  • the skull nail 1 includes: a screw rod and a screw head 14 , and the screw rod is connected to the screw head 14 .
  • the screw rod is divided into: a first connecting portion 11, a second connecting portion 12 and a third connecting portion 13, and the threads on the first connecting portion 11 and the second connecting portion 12 connected, the threads on the second connecting portion 12 and the third connecting portion 13 are connected, the threads on the first connecting portion 11 and the second connecting portion 12 are taper threads, and the taper angle of the first connecting portion 11 is 80- 100 degrees, in the extending direction from the front end to the rear end of the skull nail 1 , the diameters of the threads on the first connecting portion 11 and the second connecting portion 12 gradually increase.
  • the first connecting part 11 of the skull nail 1 is the tip part of the skull nail 1 against the skull, and then the screwdriver is inserted on the screw head 14 and screwed, due to the first connection of the skull nail 1
  • the taper angle of the connection part 11 is relatively large, so during the drilling process, the skull screw 1 can ensure high strength and self-tapping performance, prevent bending, and during the rotation process, due to the second connection and the first connection Connecting threads are also provided between the parts 11, and the tapered threads can ensure good self-tapping performance and improve the smoothness of the skull screw 1 drilling on the skull.
  • the taper angle of the second connecting portion 12 is 35-50 degrees. When the angle of the second connecting portion 12 is within this range, good self-tapping performance can be guaranteed.
  • the thread on the first connecting part 11 is the thread formed on the outer peripheral surface of the cone
  • the thread on the second connecting part 12 is the thread formed on the cone platform.
  • the top of the truncated cone of the second connecting portion 12 is connected to the bottom of the cone of the first connecting portion 11
  • the bottom of the truncated cone of the second connecting portion 12 is connected to one end of the third connecting portion 13 .
  • the thread starts from the rear end of the first connecting part 11 and surrounds the second connecting part 12 and the third connecting part 13 of the skull nail 1 in a continuous manner.
  • the turning tool of the lathe starts cutting from the second connecting part 12 and ends at the tail of the third connecting part 13, which can prevent the cutting tool from cutting the first connecting part 11, that is, the tip of the skull nail 1. Influenced by this, the material performance of the first connecting portion 11 is prevented from being reduced, that is, the hardness and strength are reduced, which further affects the effect during use.
  • the third connecting portion 13 is provided with thread, and in the extending direction from the front end to the rear end of the skull nail 1 , the diameter and pitch of the thread of the third connecting portion 13 remain unchanged.
  • the equidistant thread lines on the third connecting portion 13 can ensure relatively stable screw propulsion, and prevent the screw from being inclined to the drilled hole during screwing.
  • the cross-sectional shape of the threads on the first connecting portion 11 is trapezoidal
  • the cross-sectional shape of the threads on the second connecting portion 12 is trapezoidal
  • the cross-sectional shape of the threads on the third connecting portion 13 is trapezoidal.
  • the second connecting portion 12 mainly plays a good role in self-tapping, and needs to reflect a better drilling ability during the drilling process, wherein the trapezoidal thread section of the second connecting portion 12, in When drilling, it can effectively ensure a relatively sharp state and ensure smooth drilling.
  • the cross-sectional shape of the third connecting part 13 is trapezoidal. After the skull nail 1 is fixed, the thread of the trapezoidal cross-section can prevent the thread from breaking when the skull nail 1 is subjected to a vertical force. .
  • the hardness of the skull nail 1 is ⁇ 260HV10, and the skull nail 1 is a titanium skull nail.
  • the material of the skull nail 1 is titanium, it can ensure good biocompatibility, and has relatively stable hardness, and can be produced by lathe cutting.
  • the screw head 14 is provided with a groove for matching with a screwdriver.
  • the shape of the groove matches the current national standard screwdriver blade model on the market, and the shape of the groove is, for example, a straight line, a cross, a Pozi, a star, a square head, a hexagonal head, and a Y shape.
  • a brain electrode fixing assembly includes: a skull ring 2 and a skull nail 1 , and a threaded hole 21 is provided on the skull ring 2 .
  • the skull nail 1 is used to pass through the threaded hole 21 of the skull ring 2 and connect to the patient's skull.
  • skull nail 1 There are two symmetrically distributed through holes on the skull ring 2, and there is an inner step-like protrusion inside the skull ring 2, through which the electrode lock 3 can be supported and fixed, and at the same time, it has a good self-tapping skull Nail 1, when fixing the skull ring 2, you only need to manually pass the skull nail 1 through the through hole of the skull ring 2, align the screwdriver with the screw head 14, and turn it clockwise or counterclockwise, and the skull nail 1 will It passes smoothly through the patient's skull and is fixed on the skull.
  • the brain electrode fixing assembly also includes a cranial hole electrode lock 3 and a cranial hole cover, and a through hole is opened inside the skull ring 2, and the cranial hole electrode lock 3 is used to be arranged in the through hole of the skull ring 2, and the cranial hole cover is connected with the cranial hole cover.
  • the skull ring 2 is connected and used to seal the cranial hole electrode lock 3 in the through hole of the skull ring 2 .
  • the skull cover is connected to the skull ring 2 through a rotating shaft, and can rotate around the rotating shaft at a certain angle during use to open the through hole in the skull ring 2.
  • the cranial hole electrode lock 3 is mainly made of insulating materials, such as silica gel, rubber and other materials.
  • insulating materials such as silica gel, rubber and other materials.
  • skull nails 1 are respectively fixed on both sides of the skull ring 2, and are fastened on the skull by bolts, which have certain stability.

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Abstract

本申请公开了一种颅骨钉和脑部电极固定组件，颅骨钉具有相对的前端和后端，颅骨钉包括：螺杆和螺头，螺杆连接螺头；在颅骨钉的前端向后端的延伸方向上，螺杆划分为：第一连接部、第二连接部和第三连接部，第一连接部和第二连接部上的螺纹线相连接，第二连接部和第三连接部上的螺纹线相连接，第一连接部和第二连接部上的螺纹是锥螺纹，第一连接部的锥角为80-100度，在颅骨钉的前端向后端的延伸方向上，第一连接部和第二连接部上的螺纹线的直径逐渐增大。通过在颅骨钉上设计出具有锥角的第一连接部和第二连接部，在使用时，第一连接部的尖端能够保证在钻孔时，具有足够的强度抵抗，防止弯折，其中第二连接部可以保证较好自攻性。

Description

一种颅骨钉和脑部电极固定组件
本申请要求于2021年12月17日提交的申请号为202123200980.4的中国专利的优先权，上述中国专利通过全文引用的形式并入。
技术领域
本申请涉及颅骨固定组件技术领域，例如涉及一种颅骨钉和脑部电极固定组件。
背景技术
人的大脑是身体中最重要的部位，大脑能够指挥和协调身体的其他部位做出相应的动作。但是大脑和身体上的其他部位一样，很难保证一直处于健康的状态。当脑部神经受损时，可以通过植入电极的形式进行刺激治疗，其中固定电极的辅助工具通常需要固定在颅骨上，相关的普通颅骨钉的前端强度较弱，使用时容易断裂。
因此，仍需要一种颅骨钉满足实际使用需求。
发明内容
本申请提供了解决上述问题的一种颅骨钉和脑部电极固定组件。
本申请的目的采用以下技术方案实现：
一种颅骨钉，具有相对的前端和后端，所述颅骨钉包括：螺杆和螺头，所述螺杆连接螺头；
在所述颅骨钉的前端向后端的延伸方向上，所述螺杆划分为：第一连接部、第二连接部和第三连接部，所述第一连接部和第二连接部上的螺纹线相连接，所述第二连接部和第三连接部上的螺纹线相连接，所述第一连接部和第二连接部上的螺纹是锥螺纹，所述第一连接部的锥角为80-100度，在所述颅骨钉的前端向后端的延伸方向上，所述第一连接部和第二连接部上的螺纹线的直径逐渐增大。
在一个实施例中，所述第二连接部的锥角为35-50度。
在一个实施例中，所述第一连接部的锥角为90度，所述第二连接部的锥角为43度，所述第一连接部上的螺纹是形成于圆锥外周面上的螺纹，所述第二连 接部上的螺纹是形成于圆椎台上的螺纹，在从颅骨钉的前端到后端的延伸方向上，所述第二连接部的圆椎台的顶部连接第一连接部的圆锥底部，所述第二连接部的圆锥台底部连接第三连接部的一端。
在一个实施例中，所述第三连接部上设有螺纹线，在从颅骨钉的前端到后端的延伸方向上，所述第三连接部的螺纹线的直径和螺距保持不变。
在一个实施例中，所述第一连接部上的螺纹的截面形状是梯形，所述第二连接部上的螺纹的截面形状是梯形，所述第三连接部上的螺纹的截面形状是梯形。
在一个实施例中，所述颅骨钉的硬度≧260HV10，所述颅骨钉是颅骨钛钉。
在一个实施例中，所述螺头上开设有用于与螺丝刀相配合的凹槽。
一种脑部电极固定组件，包括：
颅骨环，所述颅骨环上设有螺纹孔；
颅骨钉，所述颅骨钉用于穿过颅骨环的螺纹孔并连接颅骨。
在一个实施例中，所述脑部电极固定组件还包括颅孔电极锁和颅孔盖，所述颅骨环内部开设通孔，所述颅孔电极锁用于设置在所述颅骨环的通孔内，所述颅孔盖与颅骨环相连并用于将颅孔电极锁封闭在所述颅骨环的通孔内。
在一个实施例中，所述颅骨环上设置有两个螺纹孔，每个螺纹孔内分别设置有一个颅骨钉。
与相关技术相比，本申请的有益效果至少包括：
本申请通过将颅骨钉设计成具有第一连接部和第二连接部的结构，第一连接部的锥角设计，能够保证颅骨钉的强度和自攻性，第二连接部的锥角能够保证良好的自攻性，以便能够稳定的将颅骨钉拧入在颅骨上，更稳定的将固定电极的辅助组件进行固定。
附图说明
图1是本申请实施例的颅骨钛钉结构示意图；
图2是本申请实施例的颅骨钉和颅骨环的配合示意图；
图3是本申请实施例的颅骨钉和脑部电极固定组件结构示意图。
图中：1、颅骨钉；11、第一连接部；12、第二连接部；13、第三连接部；14、螺头；2、颅骨环；21、螺纹孔；3、电极锁。
具体实施方式
下面，结合附图以及具体实施方式，对本申请做进一步描述，需要说明的是，在不相冲突的前提下，以下描述的各实施例之间或各技术特征之间可以任意组合形成新的实施例。
参照图1，本申请提供了一种颅骨钉，颅骨钉1包括：螺杆和螺头14，螺杆连接螺头14。
在颅骨钉1的前端向后端的延伸方向上，螺杆划分为：第一连接部11、第二连接部12和第三连接部13，第一连接部11和第二连接部12上的螺纹线相连接，第二连接部12和第三连接部13上的螺纹线相连接，第一连接部11和第二连接部12上的螺纹是锥螺纹，第一连接部11的锥角为80-100度，在颅骨钉1的前端向后端的延伸方向上，第一连接部11和第二连接部12上的螺纹线的直径逐渐增大。在工作时，首先将颅骨钉1的第一连接部11也就是颅骨钉1的尖端部分抵住在颅骨上，然后将螺丝刀插入在螺头14上，并旋拧，由于颅骨钉1的第一连接部11的锥角较大，因此在钻孔的过程中，颅骨钉1能够保证很高的强度和自攻性，防止弯折，并且在旋转的过程中，由于第二连接和第一连接部11之间还设有连接的螺纹线，锥形的螺纹线能够保证良好的自攻性，提高颅骨钉1在颅骨上钻孔的顺畅度。
其中，第二连接部12的锥角为35-50度。其中第二连接部12的角度在这一范围时都能保证良好的自攻性。
如图1所示，其中，当第一连接部11的锥角为90度，第二连接部12的锥角为43度时，为较优方案。第一连接部11上的螺纹是形成于圆锥外周面上的螺纹，第二连接部12上的螺纹是形成于圆椎台上的螺纹，在从颅骨钉1的前端到后端的延伸方向上，第二连接部12的圆椎台的顶部连接第一连接部11的圆锥底部，第二连接部12的圆锥台底部连接第三连接部13的一端。其中螺纹是从第一连接部11的后端开始并以连续的形式围绕颅骨钉1的第二连接部12和第三连接部13。在生产此类颅骨钉1时，车床的车刀从第二连接部12开始切削，到第三连接部13的尾部结束，可以避免车刀对第一连接部11也就是颅骨钉1的尖端部分的影响，防止第一连接部11的材料性能降低，即为硬度和强度降低，进而影响在使用时的效果。
其中，第三连接部13上设有螺纹线，在从颅骨钉1的前端到后端的延伸方向上，第三连接部13的螺纹线的直径和螺距保持不变。第三连接部13上的等距的螺纹线能够保证较为稳定的螺旋推进，在旋拧时，防止螺钉出现倾斜于钻孔的情况。
较优的，第一连接部11上的螺纹的截面形状是梯形，第二连接部12上的螺纹的截面形状是梯形，第三连接部13上的螺纹的截面形状是梯形。在钻进的过程中，第二连接部12主要起到良好的自攻性，并在钻进的过程中需要体现出较好的钻孔能力，其中第二连接部12的梯形螺纹截面，在钻孔时，可以有效的保证较为锋利的状态，保证钻孔顺利。并且第三连接部13上的截面形状是梯形，当颅骨钉1固定完成后，梯形截面的螺纹，可以防止当颅骨钉1上受竖直方向的力时，导致螺纹断裂，而被提出的情况。
其中，颅骨钉1的硬度≧260HV10，颅骨钉1是颅骨钛钉，其中颅骨钉1的材料是钛时可以保证良好的生物兼容性，并且具有较为稳定的硬度，可以通过车床切削加工产出。
在一具体实施方式中，螺头14上开设有用于与螺丝刀相配合的凹槽。其中凹槽的形状和目前市面上的国标螺丝刀刀口型号相匹配，凹槽的形状例如是一字形、十字形、米字形、星型形、方头形、六角头形、Y型形。
参照图2，一种脑部电极固定组件，包括：颅骨环2和颅骨钉1，颅骨环2上设有螺纹孔21。颅骨钉1用于穿过颅骨环2的螺纹孔21并连接患者的颅骨。颅骨环2上分设两个呈对称分布的通孔，并且颅骨环2的内部存在一个内台阶状的凸起，通过凸起可以将电极锁3进行支撑和固定，同时具有良好自攻性的颅骨钉1，在固定颅骨环2时，只需手动将颅骨钉1穿过颅骨环2的通孔，并将螺丝刀对准螺头14，顺时针或逆时针旋拧即可，颅骨钉1将会顺畅的穿过患者的颅骨后固定在颅骨上。
参照图3，脑部电极固定组件还包括颅孔电极锁3和颅孔盖，颅骨环2内部开设通孔，颅孔电极锁3用于设置在颅骨环2的通孔内，颅孔盖与颅骨环2相连并用于将颅孔电极锁3封闭在颅骨环2的通孔内。颅骨盖通过转轴连接在颅骨环2上，并且在使用时可以围绕转轴在一定的角度内转动，打开颅骨环2内的通孔，在使用之前，由于颅骨环2等材料均为医疗器材，颅孔盖可以保证较高的洁净度， 防止污染。颅孔电极锁3主要采用绝缘材料，例如硅胶，橡胶等材质。脑部电极固定组件的具体结构还可以参考中国专利CN110215605A中公开的内容。
参照图3，颅骨环2上设置有两个孔，每个螺纹孔21内分别设置有一个颅骨钉1。颅骨钉1分别固定在颅骨环2的两侧，并通过螺栓的形式紧固在颅骨上，具有一定的稳定性。
尽管上面已经示出和描述了本申请的实施例，可以理解的是，上述实施例是示例性的，不能理解为对本申请的限制，本领域的普通技术人员在不脱离本申请的原理和宗旨的情况下，在申请的范围内可以对上述实施例进行变化、修改、替换和变型，所有的这些改变都应该属于本申请权利要求的保护范围之内。

Claims (10)

  1. 一种颅骨钉，具有相对的前端和后端，所述颅骨钉包括：螺杆和螺头，所述螺杆连接螺头；
    在所述颅骨钉的前端向后端的延伸方向上，所述螺杆划分为：第一连接部、第二连接部和第三连接部，所述第一连接部和第二连接部上的螺纹线相连接，所述第二连接部和第三连接部上的螺纹线相连接，所述第一连接部和第二连接部上的螺纹是锥螺纹，所述第一连接部的锥角为80-100度，在所述颅骨钉的前端向后端的延伸方向上，所述第一连接部和第二连接部上的螺纹线的直径逐渐增大。
  2. 根据权利要求1所述的颅骨钉，其中，所述第二连接部的锥角为35-50度。
  3. 根据权利要求2所述的颅骨钉，其中，所述第一连接部的锥角为90度，所述第二连接部的锥角为43度，所述第一连接部上的螺纹是形成于圆锥外周面上的螺纹，所述第二连接部上的螺纹是形成于圆椎台上的螺纹，在从颅骨钉的前端到后端的延伸方向上，所述第二连接部的圆椎台的顶部连接第一连接部的圆锥底部，所述第二连接部的圆锥台底部连接第三连接部的一端。
  4. 根据权利要求1所述的颅骨钉，其中，所述第三连接部上设有螺纹线，在从颅骨钉的前端到后端的延伸方向上，所述第三连接部的螺纹线的直径和螺距保持不变。
  5. 根据权利要求4所述的颅骨钉，其中，所述第一连接部上的螺纹的截面形状是梯形，所述第二连接部上的螺纹的截面形状是梯形，所述第三连接部上的螺纹的截面形状是梯形。
  6. 根据权利要求1所述的颅骨钉，其中，所述颅骨钉的硬度≧260HV10，所述颅骨钉是颅骨钛钉。
  7. 根据权利要求1所述的颅骨钉，其中，所述螺头上开设有用于与螺丝刀相配合的凹槽。
  8. 一种脑部电极固定组件，其中，包括：
    颅骨环，所述颅骨环上设有螺纹孔；
    颅骨钉，所述颅骨钉是权利要求1-7任意一项所述的颅骨钉，所述颅骨钉用于穿过颅骨环的螺纹孔并连接颅骨。
  9. 根据权利要求8所述的脑部电极固定组件，其中，所述脑部电极固定组件还包括颅孔电极锁和颅孔盖，所述颅骨环内部开设通孔，所述颅孔电极锁用于设置在所述颅骨环的通孔内，所述颅孔盖与颅骨环相连并用于将颅孔电极锁封闭在所述颅骨环的通孔内。
  10. 根据权利要求8所述的脑部电极固定组件，其中，所述颅骨环上设置有两个螺纹孔，每个螺纹孔内分别设置有一个颅骨钉。
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