WO2024001697A1 - 一种颅孔电极固定装置 - Google Patents

一种颅孔电极固定装置 Download PDF

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Publication number
WO2024001697A1
WO2024001697A1 PCT/CN2023/098648 CN2023098648W WO2024001697A1 WO 2024001697 A1 WO2024001697 A1 WO 2024001697A1 CN 2023098648 W CN2023098648 W CN 2023098648W WO 2024001697 A1 WO2024001697 A1 WO 2024001697A1
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WO
WIPO (PCT)
Prior art keywords
electrode
cranial
foramen
lock
ring
Prior art date
Application number
PCT/CN2023/098648
Other languages
English (en)
French (fr)
Inventor
闫昊
吴国良
朱为然
Original Assignee
苏州景昱医疗器械有限公司
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Application filed by 苏州景昱医疗器械有限公司 filed Critical 苏州景昱医疗器械有限公司
Publication of WO2024001697A1 publication Critical patent/WO2024001697A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0534—Electrodes for deep brain stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • 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
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system

Definitions

  • the present application relates to the technical field of medical devices, for example, to a cranial foramen electrode fixation device.
  • Implantable medical systems usually include implanted nerve electrical stimulation systems, implantable cardiac electrical stimulation systems (commonly known as pacemakers), and implantable drug infusion systems.
  • implantable nerve electrical stimulation systems include deep brain electrical stimulation systems, implantable cerebral cortex stimulation systems, implantable spinal cord electrical stimulation systems, implantable sacral nerve electrical stimulation systems, and implantable vagus nerve electrical stimulation systems.
  • the implantable nerve electrical stimulation system mainly includes a pulse generator, electrodes and an external control device implanted in the body.
  • the pulse generator is connected to the electrode, thereby transmitting the pulse generated by the pulse generator to the electrode.
  • the pulse signal generated by the pulse generator is transmitted by the electrode to the brain or specific nerve parts for electrical stimulation, thereby restoring human body functions to normal. normal operating status.
  • the doctor first determines the target position of the patient's brain through a three-dimensional stereotaxic device. The doctor then makes a small hole in the patient's skull based on the target position and inserts the electrode into the brain target through the cranial hole. The doctor uses a test stimulator to test the implanted target. If the stimulation treatment effect is as expected, the electrode will be fixed on the skull after passing through the electrode lock. The electrode lock is used to clamp the electrode. Since the stimulation point in the brain is often small, If the electrodes for brain stimulation are slightly displaced, the stimulation may fail.
  • the purpose of this application is to provide a cranial foramen electrode fixation device that is used to reduce the movement of the electrode lock position, thereby reducing the problem of electrode stimulation failure and ensuring the effectiveness of electrode stimulation.
  • This application provides a cranial foramen electrode fixation device, including:
  • the skull ring is used to be fixed on the skull, the skull ring includes a ring part and an extension part, so The extension part is connected to the bottom end of the ring part, and the skull ring is provided with a through hole penetrating the ring part and the extension part;
  • An electrode lock the electrode lock is used to clamp the electrode, at least part of the electrode lock is provided in the through hole of the extension part, and the electrode lock is provided with a clamping opening for the power supply electrode to penetrate;
  • the locking component is movably arranged at the bottom end of the ring part and sleeved on the outside of the extension part.
  • the locking component moves from the first position to the second position, the locking component Applying force to the extension portion, the bottom opening of the through hole shrinks and presses the electrode lock, so that the electrode lock position is locked and/or the clamping opening is narrowed to clamp the electrode.
  • the locking assembly is moved from the second position When moving to the first position, the force of the locking component on the extension disappears or decreases, the opening at the bottom of the through hole exerts no pressure on the electrode lock, and the position lock of the electrode lock is released or the electrode lock is released. constraint on the electrode.
  • the side wall of the extension part is provided with one or more shrinkage grooves extending upward from the bottom and passing through the inside and outside of the extension part.
  • the contraction groove divides the extension part into at least two connected parts.
  • One or more first protrusions are provided on the outer side walls of one or more parts of the extension portion, and a third protrusion corresponding to the position of the first protrusion is provided on the inner wall of the locking assembly.
  • the locking component When the locking component is rotated until the second protrusion abuts the first protrusion, the locking component exerts force on the first protrusion of the extension part through the second protrusion.
  • the part with the first protrusion will gather toward the central axis and squeeze the electrode lock to narrow the clamping opening to clamp the electrode;
  • each part of the extension portion has no compressive effect on the electrode lock.
  • the ring portion is provided with one or more ear grooves
  • the locking assembly includes a sleeve and one or more extension ears
  • the extension ears are connected to the edge of the top of the sleeve. and extends toward the side away from the central axis of the sleeve, the extension ear corresponds to the position of the ear groove and matches the size, and the bottom of the extension ear is used to contact the skull;
  • the extending ear rotates from one side in the corresponding ear groove to the other side in the corresponding ear groove, and makes the second protrusion and
  • the portion of the extension portion with the first protrusion will gather toward the central axis and squeeze the electrode lock to clamp the electrode.
  • the cranial foramen electrode fixation device further includes a cranial foramen cover, one or more slots are provided on the ring portion, and the cranial foramen cover engages with the skull ring through the slots. And used to seal the electrode lock in the through hole;
  • the top surface of the cranial foramen cover is not higher than the top surface of the ring portion.
  • the locking assembly further includes a limiting column, and the limiting column is connected to The extension ear faces one side of the cranial foramen cover, and the cranial foramen cover is provided with a limiting hole corresponding to the position of the limiting post and matching in size;
  • the limiting post When the cranial foramen cover is connected to the skull ring, the limiting post is inserted into the corresponding limiting hole and restricts the rotation of the sleeve from the second position to the first position.
  • the outer diameter of the sleeve is no greater than 8 mm
  • the height of the sleeve is no greater than the depth of the cranial foramen
  • the ring portion is fitted to the outer surface of the skull
  • the ring portion The height is no more than 2mm.
  • the inner wall of the through hole in the extension part is in the form of an annular groove structure extending outward and smoothly transitions with the remaining inner walls of the through hole
  • the part of the electrode lock located in the through hole in the extension part is in the form of an annular groove structure extending outwards.
  • a universal ball head structure that fits the inner wall of the through hole in the extension part.
  • the part of the electrode lock that extends below the through hole gradually narrows from top to bottom.
  • the size of the opening at the lower end of the clamping port is not larger than the clamping port. The size of the upper opening.
  • the electrode lock includes a tightening part and a clamping part that are connected to each other, the tightening part and the clamping part are integrated, and at least part of the tightening part is provided on the extension part In the through hole, the lower end part of the clamping part is located below the outside of the through hole.
  • the material of the electrode lock is silica gel
  • the tightening part has a universal ball head structure
  • the clamping part has a truncated cone structure with a large end connected to the tightening part.
  • the electrode lock is made of plastic, and the tightening part and the clamping part are integrated to form a collet structure.
  • the locking component is made of metal.
  • the locking component is made of titanium alloy or stainless steel.
  • the ring portion is provided with at least two threaded holes, and the threaded holes are used for screws to penetrate and fix the skull ring to the skull.
  • the ring portion is provided with a plurality of fixing grooves for fixing electrodes, and the plurality of fixing grooves are evenly distributed around the central axis of the skull ring.
  • a cranial hole is first opened in the patient's skull, the extension of the skull ring is aligned with the cranial hole, and the skull ring is fixed on the skull.
  • the electrode is inserted into the holding port and corresponds to the target point on the brain, and is then locked by movement.
  • the locking assembly exerts force on the extension and shrinks the bottom opening of the through hole and presses the electrode lock so that the position of the electrode lock is locked and the electrode is clamped, thereby reducing the occurrence of
  • the problem of electrode stimulation failure is a cranial foramen electrode fixation device that ensures the effectiveness of electrode stimulation.
  • Figure 1 is a schematic structural diagram of a cranial foramen electrode fixation device according to an embodiment of the present application
  • Figure 2 is a schematic structural diagram 2 of the cranial foramen electrode fixation device according to the embodiment of the present application;
  • Figure 3 is a schematic structural diagram of the skull ring in the cranial foramen electrode fixation device according to the embodiment of the present application;
  • Figure 4 is a top view of the skull ring in the cranial foramen electrode fixation device according to the embodiment of the present application;
  • Figure 5 is a schematic structural diagram of the cooperation between the skull ring and the locking component in the cranial foramen electrode fixation device according to the embodiment of the present application;
  • Figure 6 is a schematic structural diagram of the cooperation between the skull ring and the first electrode lock in the cranial foramen electrode fixation device according to the embodiment of the present application;
  • Figure 7 is a schematic structural diagram of the cooperation between the skull ring and the second electrode lock in the cranial foramen electrode fixation device according to the embodiment of the present application;
  • Figure 8 is a schematic structural diagram of the cranial foramen cover in the cranial foramen electrode fixation device according to the embodiment of the present application;
  • Figure 9 is a schematic structural diagram of the sleeve in the cranial foramen electrode fixation device according to the embodiment of the present application.
  • Figure 10 is a schematic structural diagram of the first electrode lock in the cranial foramen electrode fixation device according to the embodiment of the present application.
  • Figure 11 is a schematic structural diagram of the second electrode lock in the cranial foramen electrode fixation device according to the embodiment of the present application.
  • Example embodiments will now be described more fully with reference to the accompanying drawings.
  • Example embodiments may, however, be embodied in various forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concepts of the example embodiments. To those skilled in the art.
  • the same reference numerals in the drawings represent the same or similar structures, and thus their repeated description will be omitted.
  • This application provides a cranial foramen electrode fixation device, a skull ring 1, an electrode lock 5 and a locking assembly 7.
  • Figure 1 is a schematic structural diagram of a cranial foramen electrode fixation device according to an embodiment of the present invention.
  • Figure 2 is a schematic structural diagram of a cranial foramen electrode fixation device according to an embodiment of the present invention.
  • Figure 3 is a schematic diagram of the structure of a cranial foramen electrode fixation device according to an embodiment of the present invention.
  • Figure 4 is a top view of the skull ring in the cranial foramen electrode fixation device according to the application embodiment.
  • Figure 5 is a skull ring in the cranial foramen electrode fixation device according to the application embodiment.
  • FIG 6 is a structural schematic diagram of the cooperation between the skull ring and the first electrode lock in the cranial foramen electrode fixation device according to the embodiment of the present invention.
  • Figure 7 is a structural schematic diagram of the cranial foramen electrode fixation device according to the embodiment of the present invention. Schematic diagram of the structure of the skull ring and the second electrode lock.
  • the skull ring 1 is used to be fixed on the patient's skull.
  • the skull ring 1 includes a ring part 2 and an extension part 3.
  • the extension part 3 is connected to the bottom end of the ring part 2.
  • the skull ring 1 is provided with a penetrating ring part 2 and an extension part 3.
  • the electrode lock 5 is used to clamp the electrode. At least part of the electrode lock 5 is arranged in the through hole 4 of the extension 3.
  • the electrode lock 5 is provided with a clamping opening 6 for the power supply electrode to penetrate.
  • the locking component 7 is movably disposed at the bottom end of the ring portion 2 and sleeved on the outside of the extension portion 3. When the locking component 7 moves from the first position to the second position, the locking component 7 exerts force on the extension portion 3.
  • the bottom opening of the through hole 4 shrinks and presses the electrode lock 5 so that the position of the electrode lock 5 is locked and cannot move.
  • the clamping opening 6 of the electrode lock 5 further shrinks and clamps the electrode.
  • a cranial hole is first opened in the patient's skull, and then the extension part 3 and the locking component 7 are corresponding to the cranial hole and two screws are passed through the two threaded holes 20 respectively. Fix the skull ring 1 on the outside of the skull. At this time, at least part of the extension part 3 and the locking component 7 are located in the cranial foramen.
  • the locking component 7 When moving from the first position to the second position, the locking component 7 exerts force on the extension part 3, and the bottom opening of the through hole 4 shrinks and presses the electrode lock 5 so that the position of the electrode lock 5 is locked, and the electrode lock 5 will not Movement occurs, and during the compression process, the clamping opening 6 of the electrode lock will further shrink and clamp the electrode.
  • the locking assembly 7 When it is necessary to adjust the electrode or remove the cranial foramen electrode fixation device, the locking assembly 7 will be moved from the second position Move to the first position.
  • the force exerted by the locking component 7 on the extension 3 disappears or decreases, and the opening at the bottom of the through hole 4 exerts a force on the electrode lock 5 Without pressure, the position lock of the electrode lock 5 is released, the electrode lock 5 can move in the through hole, and the clamping force of the electrode lock 5 on the electrode is reduced or the constraint on the electrode is completely released.
  • This structure can effectively avoid The electrode lock 5 moves in position after clamping the electrode, thereby reducing the possibility of electrode stimulation failure and ensuring the effectiveness of electrode stimulation.
  • Figure 9 is a schematic structural diagram of the sleeve in the cranial foramen electrode fixation device according to the embodiment of the present invention.
  • the side wall of the extension part 3 is provided with one or more shrinkage grooves 10 extending upward from the bottom and passing through the inside and outside of the extension part 3.
  • the contraction grooves 10 divide the extension part 3 into at least two connected parts.
  • the shrinking groove 10 divides the extension part 3 into at least two connected parts.
  • a first protrusion 11 is provided on the outer wall of each part of the extension part 3, and a first protrusion 11 is provided on the inner wall of the locking component 7 in a position corresponding to the first protrusion 11.
  • the locking assembly 7 when the locking assembly 7 is rotated until the second protrusion 12 abuts the first protrusion 11, the locking assembly 7 passes through the second protrusion 12.
  • the first protrusion 11 of the extension part 3 exerts force, and the part with the first protrusion 11 of the extension part 3 will gather towards the central axis and squeeze the electrode lock 5 so that the position of the electrode lock is locked and the clamping opening 6 is narrowed.
  • Clamp the electrode, and the position of the locking component 7 at this time can be defined as the first position, and the surface of the first protrusion 11 facing the second protrusion 12 is an arc surface, and the surface of the second protrusion 12 facing the first protrusion 11 The surface is flat, so that the locking component 7 rotates more smoothly and reduces the difficulty of the operation.
  • the position of the locking component 7 can be defined as the second position.
  • the above-mentioned cranial foramen electrode fixation device can clamp the electrode by rotating the locking component 7, thus greatly simplifying the surgical process and reducing the cost. Difficulty of surgery.
  • one or more ear grooves 13 are provided on the ring portion 2, and the locking assembly 7 includes a sleeve 14 and one or more ear grooves 13.
  • Two extension ears 15 are two extension ears 15 .
  • the two extension ears 15 are respectively connected to the left edge and right edge of the top of the sleeve 14 , and face away from the center of the sleeve 14 One side of the axis extends, and the extension ear 15 corresponds to the position and size of the ear groove 13.
  • the locking component 7 and the extension part 3 of the skull ring 1 are inserted into the pre-set opening.
  • the bottom of the extension ear 15 is in contact with the outside of the skull.
  • the extension ear 15 rotates from one side in the corresponding ear groove 13 to the other side in the corresponding ear groove 13.
  • the second protrusion 12 abuts the first protrusion 11.
  • the part with the first protrusion 11 of the extension part 3 will gather towards the central axis and squeeze the electrode lock 5 to clamp the electrode, and then the fixation of the electrode position can be completed.
  • the setting of the extension ear 15 can not only avoid locking components 7 falls into the brain from the cranial hole, causing a medical accident. It also facilitates the rotation of the sleeve 14 in the locking assembly 7, simplifies the surgical process, and reduces the difficulty of the surgery.
  • the medical staff can directly manually rotate the extension ear 15 to drive the sleeve 14 to rotate from the first position to the second position. At the same time, the medical staff can also use a special tool to cooperate with the extension ear 15 to rotate the sleeve 14 from the first position. Turn to second position.
  • the cranial foramen electrode fixation device also includes a cranial foramen cover 16, and one or more slots 17 are provided on the ring 2.
  • the cranial foramen cover 16 is engaged with the cranial ring 1 through the slot 17 and is used to seal the electrode lock 5 in the through hole 4. This not only simplifies the assembly, but also reduces the difficulty of the operation. In order to avoid the cranial The hole electrode fixing device is too protruding and affects the appearance of the patient's head.
  • the cranial hole cover 16 is engaged in the slot 17 , the top surface of the cranial hole cover 16 is not higher than the top surface of the ring part 2 .
  • the locking assembly 7 further includes a limiting post 18 , which is connected to a portion of the extending ear 15 facing the cranial foramen cover 16 .
  • the cranial foramen cover 16 is provided with a limiting hole 19 corresponding to the position of the limiting post 18 and matching in size.
  • the cranial foramen cover 16 can be connected to the skull ring 1
  • the limiting post 18 is inserted into the corresponding limiting hole 19
  • the sleeve 14 cannot rotate from the second position to the first position, thus avoiding the situation where the electrode lock 5 has no constraining effect on the electrode.
  • the above structure not only It is simple and fool-proof, effectively ensuring the reliability of the cranial foramen electrode fixation device.
  • the outer diameter of the sleeve 14 is no greater than 8 mm
  • the height of the sleeve 14 is no greater than the depth of the cranial foramen
  • the ring 2 is fitted to the outer surface of the skull
  • the height of the ring part 2 is no more than 2 mm.
  • the inner wall of the through hole 4 in the extension part 3 is in the form of an annular groove structure extending outward and smoothly transitions with the remaining inner walls of the through hole 4, and the electrode lock 5 is located in the extended part 3.
  • Department 3 The part inside the middle through hole 4 has a universal ball head structure that fits the inner wall of the middle through hole 4 in the extension 3. This allows the electrode lock 5 to rotate to a certain position when the electrode is inserted into the holding port 6 at an angle.
  • the electrode lock 5 extends to the bottom of the through hole 4
  • the part gradually narrows from top to bottom.
  • This structure reduces the size and cost of the electrode lock 5.
  • the size of the lower opening of the clamping port 6 is not larger than the size of the upper opening of the clamping port 6, which makes the upper end of the clamping port 6 open. The larger setting facilitates electrode insertion and reduces the difficulty of surgery, while the smaller setting of the lower opening of the clamping port 6 improves the clamping force of the electrode lock 5 on the electrodes.
  • the electrode lock 5 includes a tightening part 500 and a clamping part 501 that are connected to each other.
  • the tightening part 500 and the clamping part 501 are integrated, and at least part of the tightening part 500 is provided on the extension part 3 In the through hole 4, the lower end part of the clamping part 501 is located below the outside of the through hole 4, as shown in Figure 10.
  • Figure 10 is a schematic structural diagram of the first electrode lock in the cranial foramen electrode fixation device according to the embodiment of the present invention.
  • the material of the electrode lock 5 can be silica gel.
  • the material of silica gel can reduce the damage caused by the excessive clamping force of the electrode lock 5 on the electrode.
  • the tightening part 500 is universal.
  • the ball head structure, the clamping part 501 is a truncated cone structure with the big end connected to the tightening part 500.
  • the tightening part 500 of the above structure allows the electrode lock 5 to cooperate with electrodes with tilted implantation angles, thereby reducing the risk of electrodes caused by electrode angle deviation. In the case of displacement, it also provides more flexible path planning.
  • Figure 11 is the second electrode lock in the cranial foramen electrode fixation device according to the embodiment of the present invention. Schematic.
  • the material of the electrode lock 5 can be plastic. In this case, the tightening part 500 and the clamping part 501 are connected into a collet structure.
  • the collet structure can adapt to larger-sized electrodes, thereby The use range of the cranial foramen electrode fixation device is improved. It should be noted here that when the extension part 3 is squeezed by rotating the sleeve 14, the extension part 3 will compress the tightening part 500, so that the tightening part 500 drives the clamp The tight part 501 shrinks and clamps the electrode, which is very simple and reduces the difficulty of the operation.
  • the material of the locking component 7 is metal. In some possible implementations, the material of the locking component 7 is titanium alloy or stainless steel. The metal locking component 7 makes it difficult to deform. Causes failure, is more durable, and lasts longer.
  • the ring portion 2 is provided with multiple fixing grooves 21 for fixing electrodes, and the multiple fixing grooves 21 are evenly spaced around the central axis of the skull ring 1 distribution, in some possible implementations, the number of fixed slots 21 is not specifically limited, which satisfies a variety of electrode requirements.
  • the outlet position improves the scope of application of the cranial foramen electrode fixation device.

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Abstract

本申请公开了一种颅孔电极固定装置。本申请中颅骨环固定于颅骨上，颅骨环包括环部和延伸部，延伸部连接于环部的底端，颅骨环上设有通孔，电极锁的至少部分设于延伸部的通孔内，电极锁上设有夹持口，锁紧组件设置于环部的底端且套设在延伸部的外侧，当锁紧组件从第一位置移动至第二位置时，锁紧组件对延伸部施加作用力，通孔的底端开口缩小并压迫电极锁以使位置锁定和/或夹紧电极，当从第二位置移动至第一位置时，锁紧组件对延伸部的作用力消失或减小，通孔底端的开口对电极锁无压迫，电极锁的位置锁定解除或电极锁解除对电极的约束作用。本申请用于减少电极锁发生位置的移动，从而减少出现电极刺激失效的问题，保证了电极刺激的有效性。

Description

一种颅孔电极固定装置
本申请要求于2022年06月29日提交的申请号为CN202210752478.4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
本申请涉及医疗器械技术领域，例如涉及一种颅孔电极固定装置。
背景技术
植入式医疗***通常包括植入式神经电刺激***、植入式心脏电刺激***(俗称心脏起搏器)、植入式药物输注***。其中，植入式神经电刺激***包括脑深部电刺激***，植入式脑皮层刺激***，植入式脊髓电刺激***，植入式骶神经电刺激***，植入式迷走神经电刺激***。以植入式神经电刺激***为例，主要包括植入体内的脉冲发生器、电极以及体外的控制装置。其中，脉冲发生器与电极相连接，从而将脉冲发生器所产生的脉冲传输到电极，脉冲发生器产生的脉冲信号由电极传输至脑部或特定神经部位进行电刺激，从而使人体机能恢复到正常运作的状态。
在植入手术过程中，医生首先要通过三维立体定位装置确定病人脑部的靶点位置，医生根据靶点位置在病人的颅骨上开出小孔，将电极经颅孔***脑部靶点，医生使用测试刺激器对植入靶点进行测试，如刺激治疗效果符合预期则将电极贯穿电极锁后固定在颅骨上，电极锁用于夹紧电极，而由于脑部被刺激点往往很小，对于脑部刺激的电极如果稍有位移，就可能导致刺激失效。
因此，亟需一款能够减少电极锁发生位置的移动，从而减少出现电极刺激失效的问题，保证电极刺激有效性的颅孔电极固定装置。
发明内容
本申请的目的在于提供一种颅孔电极固定装置，用于减少电极锁发生位置的移动，从而减少出现电极刺激失效的问题，保证了电极刺激的有效性。
本申请的目的采用以下技术方案实现：
本申请提供了一种颅孔电极固定装置，包括：
颅骨环，所述颅骨环用于固定于颅骨上，所述颅骨环包括环部和延伸部，所 述延伸部连接于环部的底端，所述颅骨环上设置有贯穿环部和延伸部的通孔；
电极锁，所述电极锁用于夹紧电极，所述电极锁的至少部分设置于延伸部的通孔内，所述电极锁上设置有用于供电极贯穿的夹持口；
锁紧组件，所述锁紧组件活动设置于环部的底端且套设在所述延伸部的外侧，当所述锁紧组件从第一位置移动至第二位置时，所述锁紧组件对所述延伸部施加作用力，所述通孔的底端开口缩小并压迫电极锁，以使电极锁位置锁定和/或缩小夹持口夹紧电极，当所述锁紧组件从第二位置移动至第一位置时，所述锁紧组件对所述延伸部的作用力消失或减小，所述通孔底端的开口对电极锁无压迫，所述电极锁的位置锁定解除或解除电极锁对电极的约束作用。
在一种可能的实现方式中，所述延伸部的侧壁上设置有一个或多个从底部向上延伸并贯穿延伸部内外的收缩槽，所述收缩槽将延伸部均分为相连的至少两个部分，所述延伸部的一个或多个部分的外侧壁上均设置有一个或多个第一凸起，所述锁紧组件的内侧壁上设置有与第一凸起位置相对应的第二凸起；
当转动所述锁紧组件至第二凸起与第一凸起相抵接时，所述锁紧组件通过第二凸起对所述延伸部的第一凸起施加作用力，所述延伸部的带有第一凸起的部分会朝向其中轴线聚拢并挤压电极锁缩小夹持口夹紧电极；
当转动所述锁紧组件至第二凸起远离第一凸起时，所述延伸部的每个部分对电极锁无压迫作用。
在一种可能的实现方式中，所述环部上设置有一个或多个耳槽，所述锁紧组件包括套筒和一个或多个延伸耳，所述延伸耳连接于套筒顶部的边缘处并朝向远离套筒中轴线的一侧延伸，所述延伸耳与耳槽的位置相对应且尺寸相匹配，所述延伸耳的底部用于与颅骨相接触；
当所述套筒从第一位置转动至第二位置时，所述延伸耳从相对应耳槽内的一侧转动至相对应耳槽内的另一侧，并使得所述第二凸起与第一凸起相抵接，所述延伸部的带有第一凸起的部分会朝向其中轴线聚拢并挤压电极锁夹紧电极。
在一种可能的实现方式中，所述颅孔电极固定装置还包括颅孔盖，所述环部上设置有一个或多个卡槽，所述颅孔盖通过卡槽与颅骨环卡接配合并用于将电极锁封闭在通孔；
当所述颅孔盖卡接于卡槽内时，所述颅孔盖的顶面不高于环部的顶面。
在一种可能的实现方式中，所述锁紧组件还包括限位柱，所述限位柱连接于 延伸耳朝向颅孔盖的一侧，所述颅孔盖上设置有与限位柱位置相对应且尺寸相匹配的限位孔；
当所述颅孔盖连接于颅骨环上时，所述限位柱***相对应的限位孔内，并限制套筒从第二位置转动至第一位置。
在一种可能的实现方式中，所述套筒的外径尺寸不大于8mm，所述套筒的高度不大于颅孔的深度，所述环部贴合于颅骨的外表面，所述环部的高度不大于2mm。
在一种可能的实现方式中，所述延伸部中通孔的内壁呈向外延伸的环形凹槽结构并与通孔其余内壁圆滑过渡，所述电极锁位于延伸部中通孔内的部分呈与延伸部中通孔的内壁贴合的万向球头结构，所述电极锁延伸至通孔下方的部分从上至下逐渐收窄，所述夹持口下端开口的尺寸不大于夹持口上端开口的尺寸。
在一种可能的实现方式中，所述电极锁包括相互连通的收紧部和夹紧部，所述收紧部和夹紧部连为一体，所述收紧部的至少部分设置于延伸部的通孔内，所述夹紧部的下端部分位于通孔外的下方。
在一种可能的实现方式中，所述电极锁的材质为硅胶，所述收紧部呈万向球头结构，所述夹紧部呈大端连接所述收紧部的圆台结构。
在一种可能的实现方式中，所述电极锁的材质为塑料，所述收紧部和夹紧部连为一体后呈筒夹结构。
在一种可能的实现方式中，所述锁紧组件的材质为金属。
在一种可能的实现方式中，所述锁紧组件的材质为钛合金或不锈钢。
在一种可能的实现方式中，所述环部开设有至少两个螺纹孔，所述螺纹孔用于供螺钉贯穿并将颅骨环固定于颅骨上。
在一种可能的实现方式中，所述环部上设置有多个用于固定电极的固定槽，多个所述固定槽绕颅骨环的中轴线均匀分布。
采用本申请提供的颅孔电极固定装置，至少具有以下优点：
在手术时，先在患者颅骨上开设颅孔，将颅骨环的延伸部对应颅孔并将颅骨环固定于颅骨上，将电极***夹持口并对应至脑部靶点后，通过移动锁紧组件从第一位置移动至第二位置时，锁紧组件对延伸部施加作用力并使得通孔的底端开口缩小并压迫电极锁以使得电极锁的位置锁紧并夹紧电极，从而减少出现电极刺激失效的问题，保证电极刺激有效性的颅孔电极固定装置。
附图说明
下面结合附图和实施例对本申请进一步说明。
图1是本申请实施例颅孔电极固定装置的结构示意图一；
图2是本申请实施例颅孔电极固定装置的结构示意图二；
图3是本申请实施例颅孔电极固定装置中颅骨环的结构示意图；
图4是本申请实施例颅孔电极固定装置中颅骨环的俯视图；
图5是本申请实施例颅孔电极固定装置中颅骨环和锁紧组件配合的结构示意图；
图6是本申请实施例颅孔电极固定装置中颅骨环和第一种电极锁配合的结构示意图；
图7是本申请实施例颅孔电极固定装置中颅骨环和第二种电极锁配合的结构示意图；
图8是本申请实施例颅孔电极固定装置中颅孔盖的结构示意图；
图9是本申请实施例颅孔电极固定装置中套筒的结构示意图；
图10是本申请实施例颅孔电极固定装置中第一种电极锁的结构示意图；
图11是本申请实施例颅孔电极固定装置中第二种电极锁的结构示意图。
图中：1、颅骨环；2、环部；3、延伸部；4、通孔；5、电极锁；500、收紧部；501、夹紧部；6、夹持口；7、锁紧组件；10、收缩槽；11、第一凸起；12、第二凸起；13、耳槽；14、套筒；15、延伸耳；16、颅孔盖；17、卡槽；18、限位柱；19、限位孔；20；螺纹孔；21、固定槽。
具体实施方式
现在将参考附图更全面地描述示例实施方式。然而，示例实施方式能够以多种形式实施，且不应被理解为限于在此阐述的实施方式；相反，提供这些实施方式使得本发明更全面和完整，并将示例实施方式的构思全面地传达给本领域的技术人员。在图中相同的附图标记表示相同或类似的结构，因而将省略对它们的重复描述。
本申请中所描述的表达位置与方向的词，均是以附图为例进行的说明，但根据需要也可以做出改变，所做改变均包含在本申请保护范围内。
本申请提供一种颅孔电极固定装置，颅骨环1、电极锁5和锁紧组件7。
如图1至图7所示，图1是本发明申请实施例颅孔电极固定装置的结构示意图一，图2是本发明申请实施例颅孔电极固定装置的结构示意图二，图3是本发明申请实施例颅孔电极固定装置中颅骨环的结构示意图，图4是本发明申请实施例颅孔电极固定装置中颅骨环的俯视图，图5是本发明申请实施例颅孔电极固定装置中颅骨环和锁紧组件配合的结构示意图，图6是本发明申请实施例颅孔电极固定装置中颅骨环和第一种电极锁配合的结构示意图，图7是本发明申请实施例颅孔电极固定装置中颅骨环和第二种电极锁配合的结构示意图。颅骨环1用于固定于患者的颅骨上，颅骨环1包括环部2和延伸部3，延伸部3连接于环部2的底端，颅骨环1上设置有贯穿环部2和延伸部3的通孔4，环部2上开设有两个螺纹孔20，通过两螺钉贯穿两螺纹孔20将颅骨环1固定于脑部，螺纹孔20分布于环部2的两侧，从而避免颅骨环1出现翘边的情况，电极锁5用于夹紧电极，电极锁5的至少部分设置于延伸部3的通孔4内，电极锁5上设置有用于供电极贯穿的夹持口6，锁紧组件7活动设置于环部2的底端且套设在延伸部3的外侧，当锁紧组件7从第一位置移动至第二位置时，锁紧组件7对延伸部3施加作用力，通孔4的底端开口缩小并压迫电极锁5，以使得电极锁5的位置锁定，无法发生移动，与此同时电极锁5的夹持口6进一步缩小并夹紧电极，当锁紧组件7从第二位置移动至第一位置时，锁紧组件7对延伸部3的作用力消失或减小，通孔4底端的开口对电极锁5无压迫，此时电极锁5的位置锁定解除，电极锁5可在通孔4内发生移动，从而使得可适应更多的电极植入角度，而电极锁5对电极的夹紧力缩小或者是完全解除对电极的约束。
在一些可能的实现方式中，在医护人员进行手术时，先在患者的颅骨上开设有颅孔，随后将延伸部3和锁紧组件7对应颅孔并通过两螺钉分别贯穿两螺纹孔20后将颅骨环1固定于颅骨的外侧，此时延伸部3和锁紧组件7的至少部分位于颅孔内，随后将电极贯穿夹持口6并对应至脑部靶点，最后将锁紧组件7从第一位置移动至第二位置时，锁紧组件7对延伸部3施加作用力，通孔4的底端开口缩小并压迫电极锁5以使得电极锁5的位置锁定，电极锁5不会发生移动，而在压迫的过程中电极锁的夹持口6会进一步缩小并夹紧电极，而当需要对电极进行调整或拆除该颅孔电极固定装置时，将锁紧组件7从第二位置移动至第一位置，此时锁紧组件7对延伸部3的作用力消失或减小，通孔4底端的开口对电极锁5 无压迫，电极锁5的位置锁定解除，电极锁5可在通孔内发生移动，而电极锁5对电极的夹紧力缩小或者是完全解除对电极的约束作用，该种结构可有效避免了电极锁5在夹紧电极后发生位置的移动，从而降低了电极刺激失效的可能性，保障了电极刺激的有效性。
在一些可能的实现方式中，如图3、图6、图7和图9所示，图9是本发明申请实施例颅孔电极固定装置中套筒的结构示意图。延伸部3的侧壁上设置有一个或多个从底部向上延伸并贯穿延伸部3内外的收缩槽10，收缩槽10将延伸部3均分为相连的至少两个部分，在一些可能的实现方式中，收缩槽10将延伸部3均分为相连的至少两个部分，由于锁紧组件7从第二位置移动至第一位置时会对延伸部3施加作用力，收缩槽10的设置可使得延伸部3在收到作用力时，延伸部3的每个部分均朝通孔4的中轴线一侧聚拢，有效避免了延伸部3与锁紧组件7的硬挤压而造成损伤，提高了该颅孔电极固定装置的使用寿命，而延伸部3的每个部分的外侧壁上均设置有一个第一凸起11，锁紧组件7的内侧壁上设置有与第一凸起11位置相对应的第二凸起12，在一些可能的实现方式中，当转动锁紧组件7至第二凸起12与第一凸起11相抵接时，锁紧组件7通过第二凸起12对延伸部3的第一凸起11施加作用力，延伸部3的带有第一凸起11的部分会朝向其中轴线聚拢并挤压电极锁5以使得电极锁的位置锁定并缩小夹持口6夹紧电极，而此时锁紧组件7的位置可定义为第一位置，且第一凸起11朝向第二凸起12的面呈弧面、第二凸起12朝向第一凸起11的面呈平面，以使得锁紧组件7转动时更加顺畅，降低手术难度，而当转动锁紧组件7至第二凸起12远离第一凸起11时，延伸部3的每个部分对电极锁5无压迫作用，此时锁紧组件7的位置可定义为第二位置，上述颅孔电极固定装置通过转动锁紧组件7即可对电极进行夹紧，从而大大的简化了手术流程，降低了手术的难度。
在一些可能的实现方式中，，如图2、图4、图5和图9所示，环部2上设置有一个或多个耳槽13，锁紧组件7包括套筒14和一个或多个延伸耳15，在一些可能的实现方式中，为两个延伸耳15，两个延伸耳15分别连接于套筒14顶部的左侧边缘处和右侧边缘处，并朝向远离套筒14中轴线的一侧延伸，延伸耳15与耳槽13的位置相对应且尺寸相匹配，在一些可能的实现方式中，在手术时，锁紧组件7和颅骨环1的延伸部3对应***预先开设的颅孔内，随后将颅骨通过 两螺钉固定在颅骨上，此处需要说明的是，此时延伸耳15的底部与颅骨的外侧相接触，当套筒14从第一位置转动至第二位置时，如图5所示，此时套筒14处于第二位置，延伸耳15从相对应耳槽13内的一侧转动至相对应耳槽13内的另一侧，此时第二凸起12与第一凸起11相抵接，延伸部3的带有第一凸起11的部分会朝向其中轴线聚拢并挤压电极锁5夹紧电极，随后即可完成对电极位置的固定，延伸耳15的设置不仅可避免锁紧组件7从颅孔内掉入脑部引发医疗事故，同时也方便了对锁紧组件7中套筒14的转动，简化了手术流程，降低了手术的难度，在一些可能的实现方式中，在旋转套筒14时，医护人员可直接手动转动延伸耳15以带动套筒14从第一位置转动至第二位置，同时也可通过专用工具与延伸耳15配合，以转动套筒14从第一位置转动至第二位置。
在一些可能的实现方式中，如图1和图2所示，颅孔电极固定装置还包括颅孔盖16，环部2上设置有一个或多个卡槽17，在完成电极锁5对电极的固定后，将颅孔盖16通过卡槽17与颅骨环1卡接配合并用于将电极锁5封闭在通孔4内，不仅装配简单，同时也降低了手术的难度，而为了避免该颅孔电极固定装置过于凸出影响患者的头部美观，当颅孔盖16卡接于卡槽17内时，颅孔盖16的顶面不高于环部2的顶面。
在一些可能的实现方式中，如图2、图5、图8和图9所示，锁紧组件7还包括限位柱18，限位柱18连接于延伸耳15朝向颅孔盖16的一侧，颅孔盖16上设置有与限位柱18位置相对应且尺寸相匹配的限位孔19，当完成电极锁5对电极的固定后即可将颅孔盖16连接于颅骨环1上时，此时限位柱18***相对应的限位孔19内，套筒14即无法从第二位置转动至第一位置，从而避免了电极锁5对电极无约束作用的情况出现，上述结构不仅简单且具有防呆作用，有效保障颅孔电极固定装置的可靠性。
在一些可能的实现方式中，为了降低颅孔开设的尺寸，套筒14的外径尺寸不大于8mm，套筒14的高度不大于颅孔的深度，环部2贴合于颅骨的外表面，环部2的高度不大于2mm，上述结构不仅可降低了开设颅孔的尺寸，同时也避免了该颅孔电极固定装置过后或伸入脑部从而导致炎症等情况的出现。
在一些可能的实现方式中，如图5至图7所示，延伸部3中通孔4的内壁呈向外延伸的环形凹槽结构并与通孔4其余内壁圆滑过渡，电极锁5位于延伸部3 中通孔4内的部分呈与延伸部3中通孔4的内壁贴合的万向球头结构，这使得电极在倾斜***到夹持口6内时，电极锁5也可转动至呈一定角度，从而应对电极植入角度的偏差而造成电极位移的情况，同时也提供了更加灵活的电极植入路径规划，适应更多的电极植入角度，而电极锁5延伸至通孔4下方的部分从上至下逐渐收窄，该结构降低了电极锁5的尺寸和成本，同时夹持口6下端开口的尺寸不大于夹持口6上端开口的尺寸，这使得夹持口6的上端开口较大的设置方便电极***，降低手术难度，而夹持口6的下端开口较小的设置提高了电极锁5对电极的夹紧力。
在一些可能的实现方式中，电极锁5包括相互连通的收紧部500和夹紧部501，收紧部500和夹紧部501连为一体，收紧部500的至少部分设置于延伸部3的通孔4内，夹紧部501的下端部分位于通孔4外的下方，如图10所示，图10是本发明申请实施例颅孔电极固定装置中第一种电极锁的结构示意图。作为第一种电极锁5结构，电极锁5的材质可以为硅胶，硅胶的材质可以降低电极锁5对电极过大的夹紧力而造成损伤的情况，进一步的，收紧部500呈万向球头结构，夹紧部501呈大端连接收紧部500的圆台结构，上述结构的收紧部500使得电极锁5可配合植入角度出现倾斜的电极，在减少因电极角度偏差造成的电极位移的情况下，也提供了更加灵活的路径规划，而作为第二种电极锁5结构，如图11所示，图11是本发明申请实施例颅孔电极固定装置中第二种电极锁的结构示意图。作为第二种电极锁5结构，电极锁5的材质可以为塑料，此时收紧部500和夹紧部501连为一体后呈筒夹结构，筒夹结构可适应较大尺寸的电极，从而提高了颅孔电极固定装置的使用范围，此处需要说明的是，在转动套筒14对延伸部3进行挤压时，延伸部3会压迫收紧部500，从而使得收紧部500带动夹紧部501收缩夹紧电极，十分简便，降低了手术难度。
在一些可能的实现方式中，锁紧组件7的材质为金属，在一些可能的实现方式中，锁紧组件7的材质为钛合金或不锈钢，金属材质的锁紧组件7使得其不易发生形变而导致失效，更加耐用，且使用寿命更长。
在一些可能的实现方式中，如图1、图4至图7所示，环部2上设置有多个用于固定电极的固定槽21，多个固定槽21绕颅骨环1的中轴线均匀分布，在一些可能的实现方式中，不对固定槽21的数量作具体限定，这满足了电极的多种 出线位置，从而提高了颅孔电极固定装置的适用范围。
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 (14)

  1. 一种颅孔电极固定装置，包括：
    颅骨环，所述颅骨环用于固定于颅骨上，所述颅骨环包括环部和延伸部，所述延伸部连接于环部的底端，所述颅骨环上设置有贯穿环部和延伸部的通孔；
    电极锁，所述电极锁用于夹紧电极，所述电极锁的至少部分设置于延伸部的通孔内，所述电极锁上设置有用于供电极贯穿的夹持口；
    锁紧组件，所述锁紧组件活动设置于环部的底端且套设在所述延伸部的外侧，当所述锁紧组件从第一位置移动至第二位置时，所述锁紧组件对所述延伸部施加作用力，所述通孔的底端开口缩小并压迫电极锁，以使电极锁位置锁定和/或缩小夹持口夹紧电极，当所述锁紧组件从第二位置移动至第一位置时，所述锁紧组件对所述延伸部的作用力消失或减小，所述通孔底端的开口对电极锁无压迫，所述电极锁的位置锁定解除或解除电极锁对电极的约束作用。
  2. 根据权利要求1所述的颅孔电极固定装置，其中，所述延伸部的侧壁上设置有一个或多个从底部向上延伸并贯穿延伸部内外的收缩槽，所述收缩槽将延伸部均分为相连的至少两个部分，所述延伸部的一个或多个部分的外侧壁上均设置有一个或多个第一凸起，所述锁紧组件的内侧壁上设置有与第一凸起位置相对应的第二凸起；
    当转动所述锁紧组件至第二凸起与第一凸起相抵接时，所述锁紧组件通过第二凸起对所述延伸部的第一凸起施加作用力，所述延伸部的带有第一凸起的部分会朝向其中轴线聚拢并挤压电极锁缩小夹持口夹紧电极；
    当转动所述锁紧组件至第二凸起远离第一凸起时，所述延伸部的每个部分对电极锁无压迫作用。
  3. 根据权利要求2所述的颅孔电极固定装置，其中，所述环部上设置有一个或多个耳槽，所述锁紧组件包括套筒和一个或多个延伸耳，所述延伸耳连接于套筒顶部的边缘处并朝向远离套筒中轴线的一侧延伸，所述延伸耳与耳槽的位置相对应且尺寸相匹配，所述延伸耳的底部用于与颅骨相接触；
    当所述套筒从第一位置转动至第二位置时，所述延伸耳从相对应耳槽内的一侧转动至相对应耳槽内的另一侧，并使得所述第二凸起与第一凸起相抵接，所述延伸部的带有第一凸起的部分会朝向其中轴线聚拢并挤压电极锁夹紧电极。
  4. 根据权利要求3所述的颅孔电极固定装置，其中，所述颅孔电极固定装 置还包括颅孔盖，所述环部上设置有一个或多个卡槽，所述颅孔盖通过卡槽与颅骨环卡接配合并用于将电极锁封闭在通孔；
    当所述颅孔盖卡接于卡槽内时，所述颅孔盖的顶面不高于环部的顶面。
  5. 根据权利要求4所述的颅孔电极固定装置，其中，所述锁紧组件还包括限位柱，所述限位柱连接于延伸耳朝向颅孔盖的一侧，所述颅孔盖上设置有与限位柱位置相对应且尺寸相匹配的限位孔；
    当所述颅孔盖连接于颅骨环上时，所述限位柱***相对应的限位孔内，并限制套筒从第二位置转动至第一位置。
  6. 根据权利要求3所述的颅孔电极固定装置，其中，所述套筒的外径尺寸不大于8mm，所述套筒的高度不大于颅孔的深度，所述环部贴合于颅骨的外表面，所述环部的高度不大于2mm。
  7. 根据权利要求1所述的颅孔电极固定装置，其中，所述延伸部中通孔的内壁呈向外延伸的环形凹槽结构并与通孔其余内壁圆滑过渡，所述电极锁位于延伸部中通孔内的部分呈与延伸部中通孔的内壁贴合的万向球头结构，所述电极锁延伸至通孔下方的部分从上至下逐渐收窄，所述夹持口下端开口的尺寸不大于夹持口上端开口的尺寸。
  8. 根据权利要求1所述的颅孔电极固定装置，其中，所述电极锁包括相互连通的收紧部和夹紧部，所述收紧部和夹紧部连为一体，所述收紧部的至少部分设置于延伸部的通孔内，所述夹紧部的下端部分位于通孔外的下方。
  9. 根据权利要求8所述的颅孔电极固定装置，其中，所述电极锁的材质为硅胶，所述收紧部呈万向球头结构，所述夹紧部呈大端连接所述收紧部的圆台结构。
  10. 根据权利要求8所述的颅孔电极固定装置，其中，所述电极锁的材质为塑料，所述收紧部和夹紧部连为一体后呈筒夹结构。
  11. 根据权利要求1所述的颅孔电极固定装置，其中，所述锁紧组件的材质为金属。
  12. 根据权利要求11所述的颅孔电极固定装置，其中，所述锁紧组件的材质为钛合金或不锈钢。
  13. 根据权利要求1所述的颅孔电极固定装置，其中，所述环部开设有至少两个螺纹孔，所述螺纹孔用于供螺钉贯穿并将颅骨环固定于颅骨上。
  14. 根据权利要求1所述的颅孔电极固定装置，其中，所述环部上设置有多个用于固定电极的固定槽，多个所述固定槽绕颅骨环的中轴线均匀分布。
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