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CN111744110B - Pulse generator and implanted nerve stimulation system with wiring groove arranged on one side - Google Patents

Pulse generator and implanted nerve stimulation system with wiring groove arranged on one side Download PDF

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CN111744110B
CN111744110B CN202010505514.8A CN202010505514A CN111744110B CN 111744110 B CN111744110 B CN 111744110B CN 202010505514 A CN202010505514 A CN 202010505514A CN 111744110 B CN111744110 B CN 111744110B
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top cover
pulse generator
main body
electrode
electrode connecting
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CN111744110A (en
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张高龙
王航
马伯志
郝红伟
李路明
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Beijing Pinchi Medical Equipment Co ltd
Tsinghua University
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Beijing Pinchi Medical Equipment Co ltd
Tsinghua University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/37514Brain implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36064Epilepsy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067Movement disorders, e.g. tremor or Parkinson disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

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  • Health & Medical Sciences (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Engineering & Computer Science (AREA)
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  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Hospice & Palliative Care (AREA)
  • Child & Adolescent Psychology (AREA)
  • Developmental Disabilities (AREA)
  • Psychology (AREA)
  • Psychiatry (AREA)
  • Electrotherapy Devices (AREA)

Abstract

本发明提供一种接线槽单侧设置的脉冲发生器及植入式神经刺激系统,其中脉冲发生器,包括:顶盖部件,包括顶盖本体,以及安装在所述顶盖本体内部的电极连接装置;主体部件,包括壳体、安装在所述壳体内部的电路板、以及与所述电路板电连接的馈通导线;所述馈通导线用于插入所述顶盖部件内部与所述电极连接装置电连接;所述电极连接装置在所述顶盖本体内部设有至少两个,且向着远离所述主体部件的方向平行布置。本发明的脉冲发生器更加轻薄,在颅骨上开设骨槽的深度更浅,病人痛苦更小,手术安全性更高。

The present invention provides a pulse generator and an implantable neural stimulation system with a wiring slot arranged on one side, wherein the pulse generator comprises: a top cover component, including a top cover body, and an electrode connection device installed inside the top cover body; a main body component, including a shell, a circuit board installed inside the shell, and a feed-through wire electrically connected to the circuit board; the feed-through wire is used to be inserted into the top cover component and electrically connected to the electrode connection device; at least two electrode connection devices are provided inside the top cover body, and are arranged in parallel in a direction away from the main body component. The pulse generator of the present invention is thinner and lighter, the depth of the bone slot opened on the skull is shallower, the patient suffers less pain, and the operation is safer.

Description

一种接线槽单侧设置的脉冲发生器及植入式神经刺激系统A pulse generator and implantable neural stimulation system arranged on one side of a wiring slot

技术领域Technical Field

本发明涉及植入式医疗仪器技术领域,具体涉及一种能够用于头部植入的接线槽单侧设置的脉冲发生器及植入式神经刺激系统。The present invention relates to the technical field of implantable medical instruments, and in particular to a pulse generator and an implantable neural stimulation system which are arranged on one side of a wiring slot and can be implanted in a head.

背景技术Background Art

脑深部电刺激疗法通过对大脑深部不同功能核团进行电脉冲刺激,起到有效治疗相关疾病的作用,是一种可逆性的神经调节治疗方法。目前,脑深部电刺激疗法可应用于帕金森、癫痫、痉挛、特发性震颤等疾病的治疗,在治疗阿尔兹海默综合征、难治性抑郁、脑卒中后康复、疼痛等方面也正开展广泛的应用研究。Deep brain stimulation therapy is a reversible neuromodulation therapy that effectively treats related diseases by stimulating different functional nuclei deep in the brain with electrical pulses. At present, deep brain stimulation therapy can be used to treat Parkinson's disease, epilepsy, spasticity, essential tremor and other diseases. It is also being widely used in the treatment of Alzheimer's syndrome, refractory depression, post-stroke rehabilitation, pain and other aspects.

传统的脑深部电刺激系统的体内植入部分一般包括脉冲发生器、延长导线、电极以及电极固定装置等部分。脉冲发生器植入在胸部皮下,与延长导线连接,延长导线通过颈部皮下隧道与电极连接,电极穿过颅骨与靶点接触,并通过固定装置固定在颅骨。但在植入过程和使用过程中,颈部活动易导致连接失效,连接位点的皮肤易破溃等问题,给患者带来了极大的困扰。The implantable part of a traditional deep brain stimulation system generally includes a pulse generator, an extension lead, electrodes, and an electrode fixing device. The pulse generator is implanted under the chest skin and connected to the extension lead, which is connected to the electrode through a subcutaneous tunnel in the neck. The electrode passes through the skull to contact the target point and is fixed to the skull by a fixing device. However, during the implantation and use process, neck movement can easily lead to connection failure, and the skin at the connection site can easily break down, which brings great trouble to patients.

中国专利文献CN109364372A公开了一种顶盖部件、脉冲发生器以及植入式电刺激系统,其公开的顶盖部件中设置有两个用于供电极导线插入连接的电极连接装置,两个电极连接装置在顶盖部件中的布置方式为叠加布置。如果将该脉冲发生器植入头部,在同一位置的沿由内而外方向,分别为人体、电极连接装置、电极连接装置、头皮,由于两个电极连接装置叠加布置,设备厚度大,因而需要在颅骨上开设更深的骨槽,手术危险性较高。因此,为使脉冲发生器满足当前脑深部电刺激手术的新需求,亟需对脉冲发生器进行小型化设计与内部器件的合理布局。Chinese patent document CN109364372A discloses a top cover component, a pulse generator and an implantable electrical stimulation system, wherein the top cover component disclosed therein is provided with two electrode connection devices for inserting and connecting electrode wires, and the two electrode connection devices are arranged in a superimposed manner in the top cover component. If the pulse generator is implanted in the head, in the same position from the inside to the outside, there are the human body, the electrode connection device, the electrode connection device, and the scalp. Since the two electrode connection devices are arranged in a superimposed manner, the thickness of the device is large, and therefore a deeper bone groove needs to be opened on the skull, and the operation is more risky. Therefore, in order for the pulse generator to meet the new needs of the current deep brain electrical stimulation surgery, it is urgent to miniaturize the pulse generator and reasonably arrange the internal components.

发明内容Summary of the invention

因此,本发明要解决的技术问题在于克服现有技术中可植入电刺激系统的脉冲发生器尺寸较大,在植入头部时需要开设较深骨槽,进而导致手术危险性较高的技术缺陷,从而提供一种厚度更薄、开设骨槽浅因而手术安全性更高的脉冲发生器。Therefore, the technical problem to be solved by the present invention is to overcome the technical defects in the prior art that the pulse generator of the implantable electrical stimulation system is large in size and requires a deep bone groove to be opened when implanted in the head, which leads to a higher risk of surgery, thereby providing a pulse generator with thinner thickness, shallow bone groove and thus higher surgical safety.

本发明还提供一种具有上述脉冲发生器的神经刺激系统。The present invention also provides a neural stimulation system having the pulse generator.

为此,本发明提供一种接线槽单侧设置的脉冲发生器,包括:To this end, the present invention provides a pulse generator arranged on one side of a wiring slot, comprising:

顶盖部件,包括顶盖本体,以及安装在所述顶盖本体内部的电极连接装置;A top cover component, comprising a top cover body, and an electrode connecting device installed inside the top cover body;

主体部件,包括壳体、安装在所述壳体内部的电路板、以及与所述电路板电连接的馈通导线;所述馈通导线用于插入所述顶盖部件内部与所述电极连接装置电连接;The main body component includes a shell, a circuit board installed inside the shell, and a feedthrough wire electrically connected to the circuit board; the feedthrough wire is used to be inserted into the top cover component and electrically connected to the electrode connection device;

所述电极连接装置在所述顶盖本体内部设有至少两个,且向着远离所述主体部件的方向平行布置。At least two electrode connection devices are provided inside the top cover body and are arranged in parallel in a direction away from the main body component.

所述电极连接装置包括若干个连接器,相邻两个所述连接器之间设有绝缘环,所述连接器上均设有接线槽;The electrode connection device comprises a plurality of connectors, an insulating ring is provided between two adjacent connectors, and each connector is provided with a wiring slot;

所有的所述电极连接装置的接线槽均朝向所述顶盖部件的同一侧设置。All the wiring slots of the electrode connection devices are arranged toward the same side of the top cover component.

作为一种优选方案,所述馈通导线从所述壳体的一侧凹陷位置伸出,再插入所述顶盖部件内部,分别与相应的接线槽电连接。As a preferred solution, the feed-through wires extend from a recessed position on one side of the shell, and are then inserted into the interior of the top cover component to be electrically connected to corresponding wiring slots respectively.

作为一种优选方案,所述顶盖部件上设有若干第一限位槽,所述第一限位槽与最靠近所述主体部件的所述电极连接装置的接线槽正对,一部分所述馈通导线穿过所述第一限位槽后直接伸入最靠近所述主体部件的所述电极连接装置的所述接线槽内部与所述连接器连接。As a preferred embodiment, a plurality of first limiting grooves are provided on the top cover component, and the first limiting grooves are directly opposite to the wiring groove of the electrode connecting device closest to the main body component. A portion of the feed-through wires pass through the first limiting grooves and directly extend into the wiring groove of the electrode connecting device closest to the main body component to be connected to the connector.

所述顶盖部件上还设有若干第二限位槽,所述第二限位槽不与最靠近所述主体部件的所述电极连接装置的连接器正对,另一部分所述馈通导线穿过所述第二限位槽后,绕经所述绝缘环进入至相邻两个所述电极连接装置之间,再进入非与所述主体部件最靠近的其他所述电极连接装置的接线槽内部,与所述连接器连接。The top cover component is also provided with a plurality of second limiting grooves, which are not directly opposite to the connector of the electrode connecting device closest to the main body component. After another part of the feed-through wire passes through the second limiting groove, it goes around the insulating ring and enters between two adjacent electrode connecting devices, and then enters the wiring groove of other electrode connecting devices that are not closest to the main body component to be connected to the connector.

作为一种优选方案,所述电极连接装置具有第一定位安装部和第二定位安装部,所述顶盖本体内部设有供所述第一定位安装部和所述第二定位安装部定位安装的安装位;所述连接器和所述绝缘环设置在所述第一定位安装部和所述第二定位安装部之间。As a preferred embodiment, the electrode connecting device has a first positioning and mounting portion and a second positioning and mounting portion, and a mounting position for positioning and mounting the first positioning and mounting portion and the second positioning and mounting portion is provided inside the top cover body; the connector and the insulating ring are arranged between the first positioning and mounting portion and the second positioning and mounting portion.

作为一种优选方案,所述第二定位安装部上设有与所述电极连接装置的用于插入安装电极导线的插孔连通的第一固定孔;As a preferred solution, the second positioning and mounting portion is provided with a first fixing hole connected to the insertion hole of the electrode connecting device for inserting and mounting the electrode wire;

与所述第一固定孔相对的所述顶盖本体上设有第二固定孔;A second fixing hole is provided on the top cover body opposite to the first fixing hole;

所述第二固定孔位置安装有弹性帽,所述弹性帽上设有常闭开口;An elastic cap is installed at the position of the second fixing hole, and a normally closed opening is provided on the elastic cap;

固定螺栓,穿过所述第二固定孔后与所述第一固定孔螺接,用于挤紧插入至所述插孔内部的电极导线。A fixing bolt is passed through the second fixing hole and then screwed into the first fixing hole, so as to tighten the electrode wire inserted into the insertion hole.

作为一种优选方案,所述顶盖本体的远离所述电极连接装置的接线槽的一侧面上,设有用于容置安装充电线圈的容置槽;所述容置槽的朝向所述主体部件一侧设有用于供充电线圈穿出至所述主体部件连接的开口槽。As a preferred embodiment, a accommodating groove for accommodating and installing a charging coil is provided on one side surface of the top cover body away from the wiring groove of the electrode connecting device; an opening groove for allowing the charging coil to pass through and connect to the main body is provided on the side of the accommodating groove facing the main body.

作为一种优选方案,所述充电线圈位置使用硅橡胶包覆。As a preferred solution, the charging coil position is covered with silicone rubber.

作为一种优选方案,还包括天线,设置在所述顶盖本体的远离所述主体部件的一端,与所述电极连接装置之间形成的安装间隙内部。As a preferred solution, it also includes an antenna, which is arranged in the installation gap formed between one end of the top cover body away from the main body component and the electrode connecting device.

作为一种优选方案,在所述顶盖本体的远离所述主体部件的一端外壁上,设有凹槽,所述凹槽内部设有固定压板。As a preferred solution, a groove is provided on the outer wall of one end of the top cover body away from the main body component, and a fixed pressing plate is provided inside the groove.

本发明还提供一种植入式神经刺激系统,包括:The present invention also provides an implantable neural stimulation system, comprising:

脉冲发生器;Pulse generator;

电极导线,一端具有用于与所述脉冲发生器连接的连接触点,另一端具有适于与神经连接的刺激触点;An electrode wire, one end of which has a connection contact for connecting to the pulse generator, and the other end of which has a stimulation contact suitable for connecting to a nerve;

固定装置,用于将所述电极导线固定于颅骨;A fixing device, used for fixing the electrode wire to the skull;

体外控制设备,能够与所述脉冲发生器无线通讯;an external control device capable of wirelessly communicating with the pulse generator;

所述脉冲发生器为上述任一项所述的脉冲发生器。The pulse generator is any one of the pulse generators described above.

本发明提供的技术方案,具有以下优点:The technical solution provided by the present invention has the following advantages:

1.本发明的脉冲发生器,包括顶盖部件和主体部件,其中顶盖部件包括顶盖本体,以及在顶盖本体内部安装的电极连接装置;主体部件包括壳体、安装在壳体内部的电路板、以及与电路板电连接的馈通导线;馈通导线用于插入顶盖部件内部与电极连接装置电连接;电极连接装置在顶盖本体内部设有至少两个,且向着远离主体部件的方向平行设置;本发明的脉冲发生器,调整了电极连接装置在顶盖部件内部的排布方式,降低了顶盖部件的厚度,进而降低了整个脉冲发生器的厚度。与现有技术相比,本发明的脉冲发生器更加轻薄,在颅骨上开设骨槽的深度更浅,病人痛苦更小,手术安全性更高。1. The pulse generator of the present invention comprises a top cover component and a main body component, wherein the top cover component comprises a top cover body and an electrode connection device installed inside the top cover body; the main body component comprises a shell, a circuit board installed inside the shell, and a feedthrough wire electrically connected to the circuit board; the feedthrough wire is used to be inserted into the top cover component and electrically connected to the electrode connection device; at least two electrode connection devices are provided inside the top cover body and are arranged in parallel in a direction away from the main body component; the pulse generator of the present invention adjusts the arrangement of the electrode connection device inside the top cover component, reduces the thickness of the top cover component, and further reduces the thickness of the entire pulse generator. Compared with the prior art, the pulse generator of the present invention is thinner and lighter, the depth of the bone groove opened on the skull is shallower, the patient suffers less pain, and the operation is safer.

2.本发明的脉冲发生器,电极连接装置上的所有连接器上均设有接线槽,且所有的电极连接装置的接线槽均朝向顶盖部件的同一侧,具体为顶盖部件的朝向人体一侧,方便馈通导线集中从主体部件的一侧伸出至顶盖部件内部,进入到接线槽内部与连接器电连接,从而减少顶盖部件间连接干涉,能够将顶盖部件的厚度减薄,同时便于顶盖部件的装配。2. In the pulse generator of the present invention, all connectors on the electrode connecting devices are provided with wiring slots, and the wiring slots of all the electrode connecting devices are facing the same side of the top cover component, specifically the side of the top cover component facing the human body, so that the feed-through wires are conveniently extended from one side of the main body component to the inside of the top cover component, enter the wiring slots and are electrically connected to the connectors, thereby reducing connection interference between the top cover components, being able to reduce the thickness of the top cover component, and facilitating the assembly of the top cover component.

3.本发明的脉冲发生器,馈通导线从壳体的一侧凹陷位置伸出,插入顶盖部件内部,与相应的接线槽电连接,馈通导线从上述位置伸出,然后再分叉从不同位置插入到顶盖部件内部,与相应的接线槽电连接;馈通导线的这种从一侧集中出线,再分别从不同位置延伸至顶盖部件的出线方式,不仅避免了在主体部件的朝向顶盖部件的一侧出线带来的布线和接线复杂的问题,同时也方便主体部件的轻薄化制造。3. In the pulse generator of the present invention, the feed-through wire extends from a recessed position on one side of the shell, is inserted into the interior of the top cover component, and is electrically connected to the corresponding wiring slot. The feed-through wire extends from the above position, and then branches out and is inserted into the interior of the top cover component from different positions, and is electrically connected to the corresponding wiring slot. This method of the feed-through wire coming out from one side and then extending from different positions to the top cover component not only avoids the problem of complicated wiring and connection caused by the wire coming out from the side of the main part facing the top cover component, but also facilitates the lightweight manufacturing of the main part.

4.本发明的脉冲发生器,最靠近主体部件的电极连接装置,其连接器的安装位置使接线槽与顶盖部件上设置的第一限位槽正对,这样馈通导线从主体部件伸出后,经第一限位槽直接进入这部分接线槽内部实现电连接,线路短,几乎不占用顶盖部件的内部空间。4. The pulse generator of the present invention has an electrode connection device that is closest to the main body component, and its connector is installed at a position that makes the wiring slot face the first limiting slot provided on the top cover component. In this way, after the feed-through wire extends out from the main body component, it directly enters the interior of this part of the wiring slot through the first limiting slot to achieve electrical connection. The line is short and almost does not occupy the internal space of the top cover component.

5.本发明的脉冲发生器,非与主体部件最靠近的其他电极连接装置,顶盖部件上还设有第二限位槽,第二限位槽不与最靠近主体部件的电极连接装置的连接器正对,另一部分馈通导线穿过第二限位槽后,绕经绝缘环进入至相邻两个电极连接装置之间,再进入非与主体部件最靠近的其他电极连接装置的接线槽内部。这种设置方式,另一部分馈通导线从第二限位槽穿出后,基本是直接与绝缘环位置相对(也可以是与连接器靠近的其他位置),避免与最靠近主体部件的电极连接装置的连接器电连通;绕经绝缘环后再进入至相邻两个电极连接装置之间,电极连接装置被固定时,该部分馈通导线被压实在绝缘环和顶盖主体的内壁之间,这种布线方式,充分利用了顶盖部件内部的缝隙空间,且线路布线规整,固定结实。5. The pulse generator of the present invention is provided with a second limiting groove on the top cover part for other electrode connection devices that are not closest to the main part. The second limiting groove is not directly opposite to the connector of the electrode connection device that is closest to the main part. After the other part of the feed-through wire passes through the second limiting groove, it goes around the insulating ring and enters between two adjacent electrode connection devices, and then enters the wiring slot of other electrode connection devices that are not closest to the main part. In this arrangement, after the other part of the feed-through wire passes through the second limiting groove, it is basically directly opposite to the position of the insulating ring (it can also be other positions close to the connector), avoiding electrical connection with the connector of the electrode connection device closest to the main part; after going around the insulating ring, it enters between two adjacent electrode connection devices. When the electrode connection device is fixed, this part of the feed-through wire is compacted between the insulating ring and the inner wall of the top cover body. This wiring method makes full use of the gap space inside the top cover part, and the line wiring is regular and firmly fixed.

6.本发明的脉冲发生器,电极连接装置上设有第一定位安装部和第二定位安装部,顶盖本体上设有用于供上述第一定位安装部和第二定位安装部定位安装的安装位,这样通过将第一定位安装部和第二定位安装部在顶盖本体内部定位安装,即可将整个电极连接装置定位安装,其余空间可为馈通导线提供布线通路。6. In the pulse generator of the present invention, the electrode connecting device is provided with a first positioning mounting portion and a second positioning mounting portion, and the top cover body is provided with mounting positions for positioning and mounting the first positioning mounting portion and the second positioning mounting portion. In this way, by positioning and mounting the first positioning mounting portion and the second positioning mounting portion inside the top cover body, the entire electrode connecting device can be positioned and mounted, and the remaining space can provide a wiring path for the feed-through wire.

7.本发明的脉冲发生器,第二定位安装部上设有与电极连接装置的用于插入电极导线的插孔连通的第一固定孔,与第一固定孔相对的顶盖本体上设有第二固定孔,第二固定孔位置安装有弹性帽,弹性帽上设有常闭开口;还包括穿过第二固定孔后与第一固定孔螺接的固定螺栓。具体使用时,使用工具穿过弹性帽的常闭开口,与固定螺栓配合,拧动固定螺栓旋转,相对第一固定孔伸缩,从而紧固或解除伸入至插孔内部的电极导线。7. The pulse generator of the present invention has a first fixing hole on the second positioning and mounting part that is connected to the jack of the electrode connection device for inserting the electrode wire, a second fixing hole is provided on the top cover body opposite to the first fixing hole, an elastic cap is installed at the position of the second fixing hole, and the elastic cap has a normally closed opening; it also includes a fixing bolt that passes through the second fixing hole and is screwed to the first fixing hole. When in use, a tool is used to pass through the normally closed opening of the elastic cap, cooperate with the fixing bolt, and turn the fixing bolt to rotate, expand and contract relative to the first fixing hole, thereby tightening or releasing the electrode wire inserted into the jack.

8.本发明的脉冲发生器,顶盖本体的远离电极连接装置的接线槽的一侧面上,设有容置安装充电线圈的容置槽,充电线圈安装在此位置,脉冲发生器植入人体后,该位置朝外,便于与体外充电器配合充电;开口槽为供电线圈与主体部件连通提供线路通路。8. The pulse generator of the present invention has a groove for accommodating a charging coil on one side of the top cover body away from the wiring groove of the electrode connecting device. The charging coil is installed at this position. After the pulse generator is implanted in the human body, this position faces outward, which is convenient for charging with an external charger. The open groove provides a line path for connecting the power supply coil with the main body.

9.本发明的脉冲发生器,充电线圈位置使用硅橡胶包覆,不仅能够固定住充电线圈,而且在充电时不会产生涡流等干扰,有利于提升充电效率。9. The pulse generator of the present invention uses silicone rubber to cover the charging coil, which can not only fix the charging coil, but also does not generate interference such as eddy current during charging, which is beneficial to improving the charging efficiency.

10.本发明的脉冲发生器,顶盖本体的远离主体部件的一端,与电极连接装置之间形成安装间隙,天线安装在安装间隙内部,这种装配方式充分利用了顶盖本体的安装空间,且有利于天线与外界的信号交互。10. In the pulse generator of the present invention, an installation gap is formed between the end of the top cover body away from the main body component and the electrode connecting device, and the antenna is installed inside the installation gap. This assembly method fully utilizes the installation space of the top cover body and is conducive to the signal interaction between the antenna and the outside world.

11.本发明的脉冲发生器,顶盖本体的远离主体部件的一端外壁上,设有凹槽,凹槽内部设有固定压板,当脉冲发生器植入人体内部后,固定压板位置可以使用固定在颅骨上的压片,压住固定压板位置,实现脉冲发生器这一端的固定。11. The pulse generator of the present invention has a groove on the outer wall of one end of the top cover body away from the main body component, and a fixed pressure plate is provided inside the groove. When the pulse generator is implanted in the human body, the position of the fixed pressure plate can be pressed by a pressure piece fixed on the skull to fix this end of the pulse generator.

12.本发明提供一种植入式神经刺激系统,包括脉冲发生器、电极导线、固定装置和体外控制设备,其中脉冲发生器为上述结构的脉冲发生器,本发明的植入式神经刺激系统,由于采用了上述的脉冲发生器,因而具有应采用上述脉冲发生器而带来的一切优点,比如轻薄性好,充电效率高等。12. The present invention provides an implantable neural stimulation system, including a pulse generator, an electrode wire, a fixing device and an external control device, wherein the pulse generator is a pulse generator of the above structure. The implantable neural stimulation system of the present invention, because it adopts the above pulse generator, has all the advantages brought by the above pulse generator, such as good lightness and thinness, high charging efficiency, etc.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

为了更清楚地说明现有技术或本发明具体实施方式中的技术方案,下面对现有技术或具体实施方式描述中所使用的附图作简单介绍。In order to more clearly illustrate the technical solutions in the prior art or the specific implementation manner of the present invention, the drawings used in the description of the prior art or the specific implementation manner are briefly introduced below.

图1是本发明脉冲发生器的整体结构示意图。FIG1 is a schematic diagram of the overall structure of a pulse generator of the present invention.

图2是图1中顶盖部件和主体部件上下分离后的结构示意图。FIG. 2 is a schematic structural diagram of the top cover component and the main body component in FIG. 1 after being separated up and down.

图3是图2中主体部件的后视图。FIG. 3 is a rear view of the main body component in FIG. 2 .

图4是图2中顶盖部件的爆炸结构示意图。FIG. 4 is a schematic diagram of the exploded structure of the top cover component in FIG. 2 .

图5是电极连接装置和天线在顶盖本体内部安装的结构示意图。FIG. 5 is a schematic diagram of the structure in which the electrode connection device and the antenna are installed inside the top cover body.

图6是图5去除电极连接装置和天线后的结构示意图。FIG. 6 is a schematic diagram of the structure of FIG. 5 after removing the electrode connection device and the antenna.

图7是图6的后视图。FIG. 7 is a rear view of FIG. 6 .

图8是弹性帽的立体图。FIG. 8 is a perspective view of an elastic cap.

图9是图8的剖面图。FIG. 9 is a cross-sectional view of FIG. 8 .

图10是本发明的脉冲发生器在颅骨上固定的结构示意图。FIG. 10 is a schematic diagram of the structure of the pulse generator of the present invention fixed on the skull.

图11是图10的剖面图。FIG. 11 is a cross-sectional view of FIG. 10 .

图12是本发明实施例2中脉冲发生器的整体结构示意图。FIG12 is a schematic diagram of the overall structure of the pulse generator in Example 2 of the present invention.

图13是图12的结构爆炸示意图。FIG. 13 is a schematic exploded view of the structure of FIG. 12 .

图14是图13中顶盖部件的爆炸结构示意图。FIG. 14 is a schematic diagram of the exploded structure of the top cover component in FIG. 13 .

图15是电极连接装置和天线在顶盖本体内部安装的结构示意图。FIG. 15 is a schematic diagram of the structure in which the electrode connection device and the antenna are installed inside the top cover body.

图16是图15的后视图。FIG. 16 is a rear view of FIG. 15 .

图17是神经刺激系统在人体颅骨上固定安装的结构示意图。FIG. 17 is a schematic diagram of the structure of the neural stimulation system fixedly installed on the human skull.

图18是植入式神经刺激系统的植入流程示意图。FIG. 18 is a schematic diagram of the implantation process of the implantable neural stimulation system.

附图标记:1、顶盖部件;11、顶盖本体;12、安装位13、第二固定孔;14、弹性帽;15、常闭开口;16、容置槽;17、安装间隙;18、凹陷;101、第一限位槽;102、第二限位槽;103、凹槽;104、固定压板;105、销轴孔;2、主体部件;21、壳体;22、馈通导线;3、电极连接装置;31、第一电极连接装置;32、第二电极连接装置;301、连接器;302、绝缘环;303、接线槽;304、第一定位安装部;305、第二定位安装部;306、插孔;307、第一固定孔;4、充电线圈;40、开口槽;41、第一引线端;42、第二引线端;5、天线;6、电极导线;7、压片;8、颅骨;81、骨水泥;9、安装壳体;91、安装凸耳;92、螺钉;93、弯折压板;100、脉冲发生器;200、体外控制设备;300、固定装置。Reference numerals: 1, top cover component; 11, top cover body; 12, mounting position 13, second fixing hole; 14, elastic cap; 15, normally closed opening; 16, accommodating groove; 17, mounting gap; 18, recess; 101, first limiting groove; 102, second limiting groove; 103, groove; 104, fixed pressing plate; 105, pin hole; 2, main body component; 21, housing; 22, feed-through wire; 3, electrode connecting device; 31, first electrode connecting device; 32, second electrode connecting device; 301, connector; 302, insulating ring; 303, wiring slot; 304, first positioning and mounting portion; 305, second positioning and mounting portion; 306, jack; 307, first fixing hole; 4, charging coil; 40, opening slot; 41, first lead end; 42, second lead end; 5, antenna; 6, electrode wire; 7, pressing piece; 8, skull; 81, bone cement; 9, mounting shell; 91, mounting lug; 92, screw; 93, bending pressure plate; 100, pulse generator; 200, extracorporeal control device; 300, fixing device.

具体实施方式DETAILED DESCRIPTION

下面结合附图对本发明的技术方案进行详细描述。The technical solution of the present invention is described in detail below in conjunction with the accompanying drawings.

实施例1Example 1

本实施例提供一种接线槽单侧设置的脉冲发生器,如图1-3所示,包括:顶盖部件1,包括顶盖本体11,以及安装在所述顶盖本体11内部的电极连接装置3(本实施例中,电极连接装置3有两个,分别是第一电极连接装置31和第二电极连接装置32);主体部件2,包括壳体21、安装在所述壳体21内部的电路板(图中未示出)、以及与所述电路板电连接的馈通导线22;所述馈通导线22用于插入所述顶盖部件11内部与所述电极连接装置3电连接;所述电极连接装置3在所述顶盖本体11内部设有两个,且向着远离所述主体部件2的方向平行布置。馈通导线22分为两类,一类是图2中直且短的,用于与第一电极连接装置31电连接,另一类是图2中弯且长的,用于与第二电极连接装置32电连接。This embodiment provides a pulse generator with a single-side wiring slot, as shown in Figures 1-3, comprising: a top cover component 1, including a top cover body 11, and an electrode connection device 3 installed inside the top cover body 11 (in this embodiment, there are two electrode connection devices 3, namely a first electrode connection device 31 and a second electrode connection device 32); a main body component 2, including a shell 21, a circuit board installed inside the shell 21 (not shown in the figure), and a feed-through wire 22 electrically connected to the circuit board; the feed-through wire 22 is used to be inserted into the top cover component 11 and electrically connected to the electrode connection device 3; two electrode connection devices 3 are provided inside the top cover body 11, and are arranged in parallel in a direction away from the main body component 2. The feed-through wire 22 is divided into two categories, one is straight and short in Figure 2, used to be electrically connected to the first electrode connection device 31, and the other is curved and long in Figure 2, used to be electrically connected to the second electrode connection device 32.

本实施例的脉冲发生器,调整了电极连接装置3在顶盖部件1内部的排布方式,降低了顶盖部件1的厚度,进而降低了整个脉冲发生器的厚度。采用上述结构布置的脉冲发生器更加轻薄,在颅骨上开设骨槽的深度更浅,病人痛苦更小,手术安全性更高。The pulse generator of this embodiment adjusts the arrangement of the electrode connection device 3 inside the top cover component 1, reduces the thickness of the top cover component 1, and further reduces the thickness of the entire pulse generator. The pulse generator with the above structural arrangement is lighter and thinner, the depth of the bone groove opened on the skull is shallower, the patient suffers less pain, and the operation is safer.

如图5所示,所述电极连接装置3包括若干个连接器301(本实施例中为4个),相邻两个所述连接器301之间设有绝缘环302(本实施例中为4个),多个所述连接器301分别用于与电极导线6插入端的不同连接位接触连接,以向所述电极导线6的不同触点发出刺激信号,所述连接器301上均设有接线槽303;所有的所述电极连接装置3的接线槽303均朝向所述顶盖部件1的同一侧设置。图5所示为全部朝向纸面前方一侧。As shown in FIG5 , the electrode connection device 3 includes a plurality of connectors 301 (four in this embodiment), an insulating ring 302 (four in this embodiment) is provided between two adjacent connectors 301, and the plurality of connectors 301 are respectively used to contact and connect with different connection positions of the insertion end of the electrode wire 6 to send stimulation signals to different contact points of the electrode wire 6, and the connectors 301 are provided with wiring slots 303; all the wiring slots 303 of the electrode connection device 3 are arranged toward the same side of the top cover component 1. FIG5 shows that all of them are facing the front side of the paper.

上述将电极连接装置3的接线槽全部朝向一侧的设置形式,方便馈通导线22集中从主体部件2的一侧伸出至顶盖部件1内部,进入到接线槽303内部与连接器301电连接,减少了顶盖部件1内部各组成的连接干涉,从而有利于顶盖部件1的厚度减薄。The above-mentioned arrangement of all the wiring slots of the electrode connecting device 3 facing one side facilitates the feed-through wires 22 to extend from one side of the main body part 2 to the inside of the top cover part 1, enter the wiring slots 303 and electrically connect with the connector 301, thereby reducing the connection interference of the components inside the top cover part 1, thereby facilitating the thinning of the thickness of the top cover part 1.

相应的,所述馈通导线22从所述壳体21与所述接线槽303朝向相同的一侧凹陷18位置伸出,再插入所述顶盖部件1内部,分别与相应的接线槽303、充电线圈4、天线5电连接。馈通导线22的这种从一侧集中出线,再分别从不同位置延伸至顶盖部件1的出线方式,不仅避免了在主体部件2的朝向顶盖部件1的一侧出线带来的布线和接线复杂的问题,同时也方便主体部件2的轻薄化制造。馈通导线22只要保证能够从主体部件2的一侧凹陷18位置集中出线即可,至于其在主体部件2内部如何紧密布置,均不影响后续与顶盖部件1之间的电连接,因此有利于设计及制造时的紧凑化。Correspondingly, the feed-through wire 22 extends from the recessed position 18 on the same side of the shell 21 as the wiring slot 303, and then is inserted into the top cover component 1 to be electrically connected to the corresponding wiring slot 303, the charging coil 4, and the antenna 5, respectively. This way of outlet of the feed-through wire 22, which is concentrated from one side and then extends to the top cover component 1 from different positions, not only avoids the problem of complicated wiring and wiring caused by the outlet of the main body component 2 on the side facing the top cover component 1, but also facilitates the lightweight manufacturing of the main body component 2. As long as the feed-through wire 22 can be concentrated from the recessed position 18 on one side of the main body component 2, no matter how closely it is arranged inside the main body component 2, it will not affect the subsequent electrical connection with the top cover component 1, so it is conducive to compactness during design and manufacturing.

如图5所示,所述顶盖部件1上设有若干第一限位槽101,所述第一限位槽101与最靠近所述主体部件2的所述电极连接装置3(即图示第一电极连接装置31)的接线槽303正对,一部分所述馈通导线22穿过所述第一限位槽101后直接伸入所述第一电极连接装置31的所述接线槽303内部与所述连接器301连接。这样馈通导线22从主体部件2伸出后,经第一限位槽101直接进入这部分接线槽303内部实现电连接,线路短,几乎不占用顶盖部件1的内部空间。As shown in FIG5 , the top cover component 1 is provided with a plurality of first limiting grooves 101, and the first limiting grooves 101 are directly opposite to the wiring groove 303 of the electrode connection device 3 (i.e., the first electrode connection device 31 shown in the figure) closest to the main body component 2, and a portion of the feed-through wire 22 passes through the first limiting groove 101 and directly extends into the wiring groove 303 of the first electrode connection device 31 to connect with the connector 301. In this way, after the feed-through wire 22 extends from the main body component 2, it directly enters the interior of this part of the wiring groove 303 through the first limiting groove 101 to achieve electrical connection, and the line is short, and almost no internal space of the top cover component 1 is occupied.

所述顶盖部件1上还设有若干第二限位槽102,所述第二限位槽102不与第一电极连接装置31的连接器301正对,另一部分所述馈通导线22穿过所述第二限位槽102后,绕经所述绝缘环302进入至相邻两个所述电极连接装置3之间,再进入非与所述主体部件2最靠近的其他所述电极连接装置3(如图示第二电极连接装置32)的接线槽303内部,与所述连接器301连接。这种设置方式,另一部分馈通导线22从第二限位槽102穿出后,基本是直接与绝缘环302位置相对(也可以是与连接器301靠近的其他位置),避免与所述第一电极连接装置31的连接器301电连通;绕经绝缘环302后再进入至相邻的两个电极连接装置3(即图示第一电极连接装置31和第二电极连接装置32)之间,电极连接装置3被固定时,该部分馈通导线22被压实在绝缘环32和顶盖主体11的内壁之间,这种布线方式,充分利用了顶盖部件1内部的缝隙空间,且线路布线规整,固定结实。The top cover component 1 is also provided with a plurality of second limiting grooves 102, which are not directly opposite to the connector 301 of the first electrode connecting device 31. After another part of the feed-through wire 22 passes through the second limiting groove 102, it goes around the insulating ring 302 and enters between two adjacent electrode connecting devices 3, and then enters the wiring groove 303 of the other electrode connecting device 3 (such as the second electrode connecting device 32 shown in the figure) that is not closest to the main body component 2, and is connected to the connector 301. With this arrangement, after another part of the feed-through wire 22 passes through the second limiting groove 102, it is basically directly opposite to the insulating ring 302 (or it can be other positions close to the connector 301), avoiding electrical connection with the connector 301 of the first electrode connecting device 31; after passing through the insulating ring 302, it enters between two adjacent electrode connecting devices 3 (i.e., the first electrode connecting device 31 and the second electrode connecting device 32 shown in the figure). When the electrode connecting device 3 is fixed, this part of the feed-through wire 22 is compacted between the insulating ring 32 and the inner wall of the top cover body 11. This wiring method makes full use of the gap space inside the top cover component 1, and the line wiring is regular and firmly fixed.

如图6所示,所述电极连接装置3具有第一定位安装部304和第二定位安装部305,所述顶盖本体1内部设有供所述第一定位安装部304和所述第二定位安装部305定位安装的安装位12;所述连接器301和所述绝缘环302设置在所述第一定位安装部304和所述第二定位安装部305之间。第一定位安装部304和第二定位安装部305在顶盖本体11内部定位安装,即可将整个电极连接装置3定位安装,其余空间可为馈通导线22提供布线通路。As shown in FIG6 , the electrode connection device 3 has a first positioning and mounting portion 304 and a second positioning and mounting portion 305. The top cover body 1 is provided with a mounting position 12 for positioning and mounting the first positioning and mounting portion 304 and the second positioning and mounting portion 305; the connector 301 and the insulating ring 302 are arranged between the first positioning and mounting portion 304 and the second positioning and mounting portion 305. The first positioning and mounting portion 304 and the second positioning and mounting portion 305 are positioned and mounted inside the top cover body 11, so that the entire electrode connection device 3 can be positioned and mounted, and the remaining space can provide a wiring path for the feed-through wire 22.

如图4、图6、图8和图9所示,所述第二定位安装部305上设有与所述电极连接装置3的用于插入安装电极导线6的插孔306连通的第一固定孔307;与所述第一固定孔307相对的所述顶盖本体11上设有第二固定孔13;所述第二固定孔13位置安装有弹性帽14,所述弹性帽14上设有常闭开口15,所述第二固定孔13位于所述顶盖本体11的凹槽106内,所述凹槽19用于在所述弹性帽14周围填充密封胶;固定螺栓,穿过所述第二固定孔13与所述第一固定孔307螺接,用于挤紧插入至所述插孔306内部的电极导线6。具体使用时,使用工具穿过弹性帽14的常闭开口15,与固定螺栓配合,拧动固定螺栓旋转,相对第一固定孔307伸缩,从而紧固或解除伸入至插孔306内部的电极导线6。As shown in Fig. 4, Fig. 6, Fig. 8 and Fig. 9, the second positioning and mounting part 305 is provided with a first fixing hole 307 which is connected with the insertion hole 306 of the electrode connection device 3 for inserting and installing the electrode wire 6; the top cover body 11 is provided with a second fixing hole 13 opposite to the first fixing hole 307; an elastic cap 14 is installed at the position of the second fixing hole 13, and the elastic cap 14 is provided with a normally closed opening 15, the second fixing hole 13 is located in the groove 106 of the top cover body 11, and the groove 19 is used to fill the sealant around the elastic cap 14; a fixing bolt passes through the second fixing hole 13 and is screwed with the first fixing hole 307, and is used to squeeze the electrode wire 6 inserted into the inside of the insertion hole 306. When in use, a tool is used to pass through the normally closed opening 15 of the elastic cap 14, cooperate with the fixing bolt, and the fixing bolt is turned to rotate, and it is extended relative to the first fixing hole 307, thereby tightening or releasing the electrode wire 6 inserted into the inside of the insertion hole 306.

如图4和图7所示,所述顶盖本体11的远离所述电极连接装置3的一侧面上,设有用于容置安装充电线圈4的容置槽16;所述容置槽16的朝向所述主体部件2一侧设有用于供充电线圈4穿出至所述主体部件2连接的开口槽40。充电线圈4安装在此位置,脉冲发生器植入人体后,该位置朝外,便于与体外充电器配合充电;开口槽40为供电线圈4与主体部件2连通提供线路通路。As shown in Fig. 4 and Fig. 7, a side of the top cover body 11 away from the electrode connection device 3 is provided with a receiving groove 16 for receiving and installing the charging coil 4; the side of the receiving groove 16 facing the main body 2 is provided with an opening groove 40 for the charging coil 4 to pass through and connect to the main body 2. The charging coil 4 is installed in this position, and after the pulse generator is implanted in the human body, this position faces outward, which is convenient for charging with an external charger; the opening groove 40 provides a line path for the power supply coil 4 to communicate with the main body 2.

进一步的,所述充电线圈4位置使用硅橡胶包覆,不仅能够固定住充电线圈4,而且在充电时不会产生涡流等干扰,有利于提升充电效率。Furthermore, the charging coil 4 is coated with silicone rubber, which not only fixes the charging coil 4 but also does not generate interference such as eddy current during charging, thereby improving the charging efficiency.

如图4-6所示,还包括天线5,设置在所述顶盖本体11的远离所述主体部件2的一端,与所述电极连接装置3之间形成的安装间隙17内部。这种装配方式充分利用了顶盖本体1的安装空间,且有利于天线5与外界的信号交互。As shown in Fig. 4-6, an antenna 5 is also included, which is arranged in the installation gap 17 formed between the end of the top cover body 11 away from the main body 2 and the electrode connecting device 3. This assembly method makes full use of the installation space of the top cover body 1 and is conducive to the interaction of antenna 5 with external signals.

如图4所示,在所述顶盖本体11的远离所述主体部件2的一端外壁上,设有凹槽103,所述凹槽103内部设有固定压板104。其具体应用如图10所示,当脉冲发生器安装在人体颅骨上后,在与凹槽103相对的颅骨位置上,使用螺钉固定压片7的一端,压片7的另一端压在固定压板104位置,从而将脉冲发生器固定。As shown in FIG4 , a groove 103 is provided on the outer wall of the top cover body 11 at one end away from the main body part 2, and a fixed pressing plate 104 is provided inside the groove 103. Its specific application is shown in FIG10 , when the pulse generator is installed on the human skull, a screw is used to fix one end of the pressing plate 7 at the skull position opposite to the groove 103, and the other end of the pressing plate 7 is pressed on the fixed pressing plate 104 position, thereby fixing the pulse generator.

本实施例中,顶盖部件1和主体部件2通过套设卡接的方式固定连接,如图2所示,主体部件2的朝向顶盖部件1的一端设有三个销轴23,顶盖部件1的底部设有用于供主体部件2端部插入的空腔,在空腔相应位置的内壁上,设有销轴孔105,当顶盖部件1和主体部件2装配时,主体部件2的端部伸入顶盖部件1的底部空腔内一部分,然后使三个销轴23分别从三个相应的销轴孔105位置穿出,即可完成固定卡接。In this embodiment, the top cover component 1 and the main body component 2 are fixedly connected by means of sleeve clamping. As shown in Figure 2, three pins 23 are provided at one end of the main body component 2 facing the top cover component 1, and a cavity is provided at the bottom of the top cover component 1 for inserting the end of the main body component 2. A pin hole 105 is provided on the inner wall at the corresponding position of the cavity. When the top cover component 1 and the main body component 2 are assembled, the end of the main body component 2 extends into a part of the bottom cavity of the top cover component 1, and then the three pins 23 are respectively passed through the three corresponding pin holes 105 positions to complete the fixed clamping.

本实施例中,脉冲发生器通过安装装置安装在颅骨8的骨槽内部,具体如图10所示,首先将安装壳体9放置在骨槽内部,安装壳体9上的安装凸耳91上设有安装孔,使用螺钉92从安装孔位置旋入颅骨8,完成安装壳体9的固定安装;然后将脉冲发生器放置到安装壳体9内部,安装壳体9的一端设有弯折压板93,弯折压板93与安装壳体9之间形成安装空间,脉冲发生器的一端伸入至此安装空间内部,被安装壳体9和弯折压板93挤压固定,脉冲发生器的另一端即设有上述凹槽103和固定压板104的一端,使用螺钉在颅骨上固定压片7的一端,压片7的另外一端按压在固定压板104位置,从而将脉冲发生器的另一端也固定住,从而人实现脉冲发生器在颅骨内部的安装。本实施例中的脉冲发生器,在完成上述安装后,第一电极连接装置31和第二电极连接装置32以非叠加的平铺方式布置在骨槽内部,所需骨槽深度浅。In this embodiment, the pulse generator is installed inside the bone groove of the skull 8 through an installation device, as shown in Figure 10. First, the installation shell 9 is placed inside the bone groove. The installation lug 91 on the installation shell 9 is provided with a mounting hole. The screw 92 is used to screw into the skull 8 from the mounting hole position to complete the fixed installation of the installation shell 9; then the pulse generator is placed inside the installation shell 9. One end of the installation shell 9 is provided with a bent pressure plate 93. An installation space is formed between the bent pressure plate 93 and the installation shell 9. One end of the pulse generator extends into the installation space and is squeezed and fixed by the installation shell 9 and the bent pressure plate 93. The other end of the pulse generator is provided with the above-mentioned groove 103 and one end of the fixed pressure plate 104. One end of the pressure plate 7 is fixed to the skull with a screw, and the other end of the pressure plate 7 is pressed on the fixed pressure plate 104 position, thereby fixing the other end of the pulse generator, thereby realizing the installation of the pulse generator inside the skull. In the pulse generator of this embodiment, after the above installation is completed, the first electrode connecting device 31 and the second electrode connecting device 32 are arranged inside the bone groove in a non-overlapping flat manner, and the required bone groove depth is shallow.

实施例2Example 2

本实施例提供一种接线槽双侧设置的脉冲发生器,包括:顶盖部件1,包括顶盖本体11,以及安装在所述顶盖本体11内部的电极连接装置3;主体部件2,包括壳体21、安装在所述壳体21内部的电路板、以及与所述电路板电连接的馈通导线22;所述馈通导线22用于插入所述顶盖部件11内部与所述电极连接装置3电连接;所述电极连接装置3在所述顶盖本体11内部设有两个,且向着远离所述主体部件2的方向平行布置;所述电极连接装置3包括若干个连接器301,相邻两个所述连接器301之间设有绝缘环302,所述连接器301上均设有接线槽303;一个所述电极连接装置3的接线槽303朝向所述顶盖部件1的一侧设置;另一个所述电极连接装置3的接线槽303朝向所述顶盖部件1另一侧设置。The present embodiment provides a pulse generator with wiring slots arranged on both sides, comprising: a top cover component 1, comprising a top cover body 11, and an electrode connecting device 3 installed inside the top cover body 11; a main body component 2, comprising a shell 21, a circuit board installed inside the shell 21, and a feed-through wire 22 electrically connected to the circuit board; the feed-through wire 22 is used to be inserted into the top cover component 11 and electrically connected to the electrode connecting device 3; two electrode connecting devices 3 are arranged inside the top cover body 11, and are arranged in parallel in a direction away from the main body component 2; the electrode connecting device 3 comprises a plurality of connectors 301, an insulating ring 302 is arranged between two adjacent connectors 301, and wiring slots 303 are arranged on each of the connectors 301; the wiring slot 303 of one electrode connecting device 3 is arranged toward one side of the top cover component 1; the wiring slot 303 of another electrode connecting device 3 is arranged toward the other side of the top cover component 1.

本实施例的脉冲发生器,调整了电极连接装置3在顶盖部件1内部的排布方式,降低了顶盖部件1的厚度,进而降低了整个脉冲发生器的厚度。一个电极连接装置3的接线槽303朝向顶盖部件1的一侧设置,另一个电极连接装置3的接线槽303朝向顶盖部件1的另一侧设置,方便馈通导线22从主体部件2的一侧伸出至顶盖部件1内部后,直接进入到接线槽303内部与连接器301电连接,从而能够将顶盖部件1的厚度减薄。本实施例的脉冲发生器更加轻薄,在颅骨上开设骨槽的深度更浅,病人痛苦更小,手术安全性更高。The pulse generator of this embodiment adjusts the arrangement of the electrode connection device 3 inside the top cover component 1, reduces the thickness of the top cover component 1, and further reduces the thickness of the entire pulse generator. The wiring slot 303 of one electrode connection device 3 is set toward one side of the top cover component 1, and the wiring slot 303 of the other electrode connection device 3 is set toward the other side of the top cover component 1, so that the feed-through wire 22 extends from one side of the main body component 2 to the inside of the top cover component 1, and then directly enters the wiring slot 303 to be electrically connected to the connector 301, thereby reducing the thickness of the top cover component 1. The pulse generator of this embodiment is thinner and lighter, and the depth of the bone groove opened on the skull is shallower, the patient suffers less pain, and the operation is safer.

所述馈通导线22从所述壳体21的朝向所述顶盖部件1的一侧伸出,再插入所述顶盖部件1内部,分别与相应的接线槽303电连接。The feedthrough wires 22 extend from a side of the housing 21 facing the top cover component 1 , and are then inserted into the top cover component 1 to be electrically connected to corresponding wiring slots 303 .

所述顶盖部件1的一侧设有若干第一限位槽101,所述第一限位槽101与一个所述电极连接装置3的接线槽303正对,一部分所述馈通导线22穿过所述第一限位槽101后直接伸入一个所述电极连接装置3的所述接线槽303内部与所述连接器301连接。A plurality of first limiting grooves 101 are provided on one side of the top cover component 1, and the first limiting grooves 101 are directly opposite to a wiring groove 303 of the electrode connecting device 3, and a portion of the feed-through wires 22 pass through the first limiting grooves 101 and directly extend into the wiring groove 303 of the electrode connecting device 3 to be connected with the connector 301.

所述顶盖部件1的另一侧设有若干第二限位槽102,所述第二限位槽102与另一个所述电极连接装置3的连接器301正对,另一部分所述馈通导线22穿过所述第二限位槽102后,再进入另一个所述电极连接装置3的接线槽303内部,与所述连接器301连接。A plurality of second limiting grooves 102 are provided on the other side of the top cover component 1, and the second limiting grooves 102 are directly opposite to the connector 301 of the other electrode connecting device 3. After another part of the feed-through wire 22 passes through the second limiting grooves 102, it enters the wiring groove 303 of the other electrode connecting device 3 and is connected to the connector 301.

所述电极连接装置3具有第一定位安装部304和第二定位安装部305,所述顶盖本体1内部设有供所述第一定位安装部304和所述第二定位安装部305定位安装的安装位12;所述连接器301和所述绝缘环302设置在所述第一定位安装部304和所述第二定位安装部305之间。The electrode connecting device 3 has a first positioning and mounting portion 304 and a second positioning and mounting portion 305 , and a mounting position 12 for positioning and mounting the first positioning and mounting portion 304 and the second positioning and mounting portion 305 is provided inside the top cover body 1 ; the connector 301 and the insulating ring 302 are arranged between the first positioning and mounting portion 304 and the second positioning and mounting portion 305 .

所述第二定位安装部305上设有与所述电极连接装置3的用于插入安装电极导线6的插孔306连通的第一固定孔307;与所述第一固定孔307相对的所述顶盖本体11上设有第二固定孔13;所述第二固定孔13位置安装有弹性帽14,所述弹性帽14上设有常闭开口15;固定螺栓,穿过所述第二固定孔13后与所述第一固定孔307螺接,用于挤紧插入至所述插孔306内部的电极导线6。The second positioning and mounting portion 305 is provided with a first fixing hole 307 which is connected to the socket 306 of the electrode connecting device 3 for inserting and mounting the electrode wire 6; a second fixing hole 13 is provided on the top cover body 11 opposite to the first fixing hole 307; an elastic cap 14 is installed at the position of the second fixing hole 13, and a normally closed opening 15 is provided on the elastic cap 14; a fixing bolt passes through the second fixing hole 13 and is screwed to the first fixing hole 307, so as to tighten the electrode wire 6 inserted into the socket 306.

具体使用时,使用工具穿过弹性帽14的常闭开口15,与固定螺栓配合,拧动固定螺栓旋转,相对第一固定孔307伸缩,从而紧固或解除伸入至插孔306内部的电极导线6。During specific use, a tool is used to pass through the normally closed opening 15 of the elastic cap 14 and cooperate with the fixing bolt. The fixing bolt is turned to rotate and expand relative to the first fixing hole 307, thereby tightening or releasing the electrode wire 6 inserted into the inside of the plug hole 306.

所述顶盖本体11的远离所述电极连接装置3的一侧面上,设有用于容置安装充电线圈4的容置槽16。充电线圈4安装在此位置,脉冲发生器植入人体后,该位置朝外,便于与体外充电器配合充电。A side surface of the top cover body 11 away from the electrode connection device 3 is provided with a receiving groove 16 for receiving and installing the charging coil 4. The charging coil 4 is installed at this position, and after the pulse generator is implanted in the human body, this position faces outward, which is convenient for charging with an external charger.

所述充电线圈4位置使用硅橡胶包覆,不仅能够固定住充电线圈4,而且在充电时不会产生涡流等干扰,有利于提升充电效率。The charging coil 4 is covered with silicone rubber, which not only fixes the charging coil 4 but also does not generate interference such as eddy current during charging, thereby improving the charging efficiency.

还包括天线5,设置在所述顶盖本体11的远离所述主体部件2的一端,与所述电极连接装置3之间形成的安装间隙17内部,这种装配方式充分利用了顶盖本体的安装空间,且有利于天线与外界的信号交互。It also includes an antenna 5, which is arranged at one end of the top cover body 11 away from the main part 2 and inside the installation gap 17 formed between the electrode connecting device 3. This assembly method fully utilizes the installation space of the top cover body and is conducive to the signal interaction between the antenna and the outside world.

实施例3Example 3

本实施例提供一种植入式神经刺激系统,如图17所示,包括:脉冲发生器100;电极导线6,一端具有用于与所述脉冲发生器连接的连接触点,另一端具有适于与神经连接的刺激触点;固定装置300,用于将所述电极导线6固定于颅骨;体外控制设备200,能够与所述脉冲发生器无线通讯;所述脉冲发生器为实施例1或实施例2中所述的脉冲发生器。The present embodiment provides an implantable neural stimulation system, as shown in FIG17 , comprising: a pulse generator 100; an electrode wire 6, one end of which has a connection contact for connecting to the pulse generator, and the other end of which has a stimulation contact suitable for connecting to a nerve; a fixing device 300, used to fix the electrode wire 6 to the skull; an external control device 200, capable of wirelessly communicating with the pulse generator; the pulse generator is the pulse generator described in Example 1 or Example 2.

本实施例的植入式神经刺激系统,由于采用了实施例1或实施例2中的脉冲发生器,因而自然具有应采用上述脉冲发生器而带来的一切优点,比如轻薄性好,充电效率高等等。The implantable neural stimulation system of this embodiment, since it adopts the pulse generator in Example 1 or Example 2, naturally has all the advantages brought by adopting the above-mentioned pulse generator, such as good lightness, high charging efficiency, etc.

图18为本发明植入式神经刺激系统的植入流程示意图。首先进行步骤s00,按照传统的方法在颅骨开孔,植入刺激电极并完成电极的固定,测试电极正常后,执行步骤s01;在安装脉冲发生器100的位置切开头皮,露出颅骨,按照脉冲发生器100的形状制备出颅骨骨槽;然后执行步骤s02,放置脉冲发生器安装壳体9并固定于颅骨;然后执行步骤s03,在脉冲发生器切口与电极切口间创建皮下隧道,将电极导线6的连接端穿过皮下隧道,到达脉冲发生器100的植入位置,多余电极导线6可以在电极固定装置300周围缠绕几圈。然后执行步骤s04,连接电极和脉冲发生器100,并锁紧;然后执行步骤s05,将脉冲发生器100固定在安装壳体9上。最后,执行步骤s06,用体外程控仪对植入系统进行测试,测试正常后缝合切口,完成植入。FIG18 is a schematic diagram of the implantation process of the implantable neural stimulation system of the present invention. First, step s00 is performed. According to the traditional method, a hole is opened in the skull, the stimulation electrode is implanted and the electrode is fixed. After the electrode is tested to be normal, step s01 is performed; the scalp is cut at the location where the pulse generator 100 is installed to expose the skull, and a skull bone groove is prepared according to the shape of the pulse generator 100; then step s02 is performed, the pulse generator installation shell 9 is placed and fixed to the skull; then step s03 is performed, a subcutaneous tunnel is created between the pulse generator incision and the electrode incision, and the connecting end of the electrode wire 6 is passed through the subcutaneous tunnel to reach the implantation position of the pulse generator 100. The excess electrode wire 6 can be wrapped around the electrode fixing device 300 for several turns. Then step s04 is performed to connect the electrode and the pulse generator 100 and lock them; then step s05 is performed to fix the pulse generator 100 on the installation shell 9. Finally, step s06 is performed to test the implantation system with an in vitro programmer. After the test is normal, the incision is sutured to complete the implantation.

显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims (8)

1. A pulse generator with a wiring trough single-sided arrangement, comprising:
a cap member (1) including a cap body (11), and an electrode connection device (3) mounted inside the cap body (11);
A body member (2) including a housing (21), a circuit board mounted inside the housing (21), and a feed-through wire (22) electrically connected to the circuit board; the feed-through wire (22) is used for being inserted into the top cover part (1) to be electrically connected with the electrode connecting device (3);
the method is characterized in that: the electrode connecting device (3) is provided with at least two inside the top cover body (11) and is arranged in parallel towards the direction away from the main body part (2);
The electrode connecting device (3) comprises a plurality of connectors (301), an insulating ring (302) is arranged between two adjacent connectors (301), and wiring grooves (303) are formed in each connector (301);
all the connection slots (303) of the electrode connection means (3) are arranged towards the same side of the cover member (1);
The feed-through wires (22) extend out from the concave (18) position at one side of the shell (21) and are inserted into the top cover part (1) to be electrically connected with the corresponding wiring grooves (303) respectively;
A plurality of first limit grooves (101) are formed in the top cover part (1), the first limit grooves (101) are opposite to the wiring grooves (303) of the electrode connecting device (3) closest to the main body part (2), and a part of feed-through wires (22) penetrate through the first limit grooves (101) and then directly extend into the wiring grooves (303) of the electrode connecting device (3) closest to the main body part (2) to be connected with the connector (301);
The top cover part (1) is also provided with a plurality of second limit grooves (102), the second limit grooves (102) are not opposite to the connectors (301) of the electrode connecting devices (3) closest to the main body part (2), and after the other part of feed-through wires (22) pass through the second limit grooves (102), the feed-through wires enter between the two adjacent electrode connecting devices (3) by bypassing the insulating ring (302) and then enter the inside of the wiring grooves (303) of the other electrode connecting devices (3) not closest to the main body part (2) to be connected with the connectors (301);
The thickness of the main body part (2) is basically the same as that of the top cover part (1), and the thickness of the main body part (2) is larger than that of one electrode connecting device (3) and smaller than that of two electrode connecting devices (3).
2. The pulse generator of claim 1, wherein: the electrode connecting device (3) is provided with a first positioning installation part (304) and a second positioning installation part (305), and an installation position (12) for positioning and installing the first positioning installation part (304) and the second positioning installation part (305) is arranged in the top cover body (11); the connector (301) and the insulating ring (302) are disposed between the first positioning mounting portion (304) and the second positioning mounting portion (305).
3. The pulse generator of claim 2, wherein: the second positioning and mounting part (305) is provided with a first fixing hole (307) communicated with an inserting hole (306) of the electrode connecting device (3) for inserting and mounting the electrode wire (6);
a second fixing hole (13) is formed in the top cover body (11) opposite to the first fixing hole (307);
an elastic cap (14) is arranged at the position of the second fixing hole (13), and a normally closed opening (15) is arranged on the elastic cap (14);
The fixing bolt passes through the second fixing hole (13) and then is in threaded connection with the first fixing hole (307) and is used for tightly pressing the electrode lead (6) inserted into the jack (306).
4. The pulse generator of claim 1, wherein: a containing groove (16) for containing and installing the charging coil (4) is arranged on one side surface of the top cover body (11) which is far away from the wiring groove (303) of the electrode connecting device (3); an open slot (40) used for the charging coil (4) to penetrate out to be connected with the main body part (2) is arranged on one side of the accommodating groove (16) facing the main body part (2).
5. The pulse generator of claim 4, wherein: the charging coil (4) is coated with silicone rubber.
6. The pulse generator of claim 1, wherein: the device also comprises an antenna (5) which is arranged in an installation gap (17) formed between one end of the top cover body (11) which is far away from the main body part (2) and the electrode connecting device (3).
7. The pulse generator of claim 1, wherein: the top cover comprises a top cover body (11), wherein a groove (103) is formed in the outer wall of one end, far away from the main body part (2), of the top cover body, and a fixed pressing plate (104) is arranged in the groove (103).
8. An implantable neurostimulation system comprising:
a pulse generator;
An electrode lead (6) having a connection contact at one end for connection to the pulse generator and a stimulation contact at the other end adapted for connection to a nerve;
a fixing device for fixing the electrode lead (6) to the skull;
An in vitro control device capable of wireless communication with the pulse generator;
the method is characterized in that:
The pulse generator is a pulse generator as claimed in any one of claims 1 to 7.
CN202010505514.8A 2020-06-05 2020-06-05 Pulse generator and implanted nerve stimulation system with wiring groove arranged on one side Active CN111744110B (en)

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