WO2023029086A1 - 神经电刺激设备及其连接模块和连接装置 - Google Patents

神经电刺激设备及其连接模块和连接装置 Download PDF

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Publication number
WO2023029086A1
WO2023029086A1 PCT/CN2021/118192 CN2021118192W WO2023029086A1 WO 2023029086 A1 WO2023029086 A1 WO 2023029086A1 CN 2021118192 W CN2021118192 W CN 2021118192W WO 2023029086 A1 WO2023029086 A1 WO 2023029086A1
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WIPO (PCT)
Prior art keywords
electrical connection
connection
circuit
electrical
contact
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PCT/CN2021/118192
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English (en)
French (fr)
Inventor
吴国良
章海涛
朱为然
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苏州景昱医疗器械有限公司
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Publication of WO2023029086A1 publication Critical patent/WO2023029086A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • A61N1/0534Electrodes for deep brain stimulation
    • 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

Definitions

  • the present application relates to the technical field of nerve electrical stimulation medical equipment, in particular to a nerve electrical stimulation equipment, a connection module and a connection device thereof.
  • Deep brain stimulation therapy can effectively treat related diseases by stimulating different functional nuclei in the deep part of the brain with electrical pulses. It is a reversible neuromodulation treatment method. At present, deep brain stimulation therapy can be applied to the treatment of Parkinson's, epilepsy, spasticity, essential tremor and other diseases. Conduct broad applied research.
  • the implanted part of a traditional deep brain stimulation system generally includes a pulse generator, an extension wire, electrodes, and an electrode fixing device.
  • the pulse generator is implanted under the skin of the chest and connected to the extension wire.
  • the extension wire is connected to the electrode through the subcutaneous tunnel in the neck.
  • the electrode passes through the skull to contact the target point and is fixed to the skull through a fixation device.
  • Chinese invention patent CN111744110A discloses a pulse generator and an implanted nerve stimulation system with one side of the wiring slot, including a housing, a circuit board installed inside the housing, and a feedthrough wire electrically connected to the circuit board;
  • the conducting wire is used to insert into the top cover part and electrically connect with the electrode connection device; there are at least two electrode connection devices inside the top cover body, and they are arranged parallel to the direction away from the main part. It is lighter and thinner, and the depth of the bone groove on the skull is shallower, the patient suffers less, and the operation safety is higher.
  • connection module (the electrode connecting device among the CN111744110A) of nerve electrical stimulation equipment (pulse generator in CN111744110A) comprises the insulation ring and the metal ring (connector 301 among the CN111744110A) that alternately are assembled
  • the connection channel, the electrical connection between the circuit in the pulse generator and the connection module is often connected by lead wires, which makes the connection module larger in size, causing greater trauma to the patient, and inconvenient production and assembly, resulting in assembly errors, resulting in product failure.
  • the problem of poor consistency is often connected by lead wires, which makes the connection module larger in size, causing greater trauma to the patient, and inconvenient production and assembly, resulting in assembly errors, resulting in product failure.
  • the purpose of this application is to provide a nerve electrical stimulation device and its connection module and connection device, so as to solve the problem that the connection module of the nerve electrical stimulation device in the prior art is relatively large in size, which causes great trauma to the patient, and is inconvenient for production and assembly. , resulting in assembly errors, resulting in poor product consistency.
  • the present application provides a connection module of electrical nerve stimulation equipment for electrical connection with electrode wires
  • the connection module includes: a first insulating body, the first insulating body has a first outer surface and a connection channel , the connection channel is used to install the plug-in end of the electrode wire, and a plurality of first electrical connection contacts are arranged in the connection channel, and the first electrical connection contacts are used to connect with the plug-in end of the electrode wire
  • the plug contacts on the electrical connection the connection module also includes: a plurality of second electrical connection contacts, a plurality of first circuits; each of the second electrical connection contacts is arranged on the first outer surface, and The first electrical connection contacts are respectively electrically connected through the first circuit.
  • the beneficial effect of this technical solution is that: the first electrical connection contact, the first circuit and the second electrical connection contact are arranged on the first insulating body, replacing the structure of alternating insulating rings and metal rings in the prior art, realizing The function of electrical connection with the electrode wire, the connection module in this technical solution is compact in structure, small in size, less traumatic to the patient, and does not need to be assembled with insulating rings and metal rings, saving procedures, no assembly errors, and product consistency good.
  • connection module further includes a plurality of elastic electrical connectors, the plurality of elastic electrical connectors are arranged inside the connection channel and arranged in a straight line along the length direction of the connection channel, each Each of the elastic electrical connectors is electrically connected to one of the first electrical connection contacts and is used for electrical connection with a plug contact on the plug end of the electrode lead.
  • the beneficial effect of this technical solution is that the first electrical connection contact is electrically connected to a contact on the plug-in end of the electrode wire by using the elastic electrical connection, and the elastic electrical connection has elasticity, so that the first electrical connection contact is connected to the electrode lead.
  • the electrical connection of a contact on the plug end of the electrode lead is more stable.
  • the elastic electrical connector is a metal spring ring
  • the metal spring ring is used to be sleeved on a plurality of plug-in contacts of the plug-in end of the electrode wire.
  • the first insulating body is at least composed of a first insulating component and a second insulating component, and the material of the first insulating component and/or the second insulating component includes ceramic or plastic;
  • the first insulating component and the second insulating component include a plurality of arc-shaped grooves arranged in a straight line along the length direction of the connecting channel.
  • the beneficial effect of this technical solution is that: the combination of the first insulating body by using the split structure makes the manufacture of the first insulating body more convenient, and at the same time, it is also convenient to construct the first electrical connection contact and the first insulating body on the first insulating body.
  • the circuit and the metal spring ring are conveniently assembled into the first channel; the plurality of arc-shaped grooves have a limiting effect on the metal spring ring, making the installation and electrical contact of the metal spring ring more stable and reliable.
  • the first insulating body includes a plurality of first hole structures, the first hole structures communicate with the first outer surface and the connecting channel, and the first circuit includes a A first surface circuit on the first outer surface of an insulating body and a first hole circuit arranged in the first hole structure; the first surface circuit is electrically connected to the second electrical connection contact and the first A hole circuit, the first hole circuit is electrically connected to the first electrical connection contact.
  • the beneficial effect of this technical solution is that the first surface circuit is constructed on the first insulating body, and the first hole structure is provided, and the first hole circuit is constructed by using the first hole structure to realize the above-mentioned electrical connection. Simply setting the circuit on the surface of the first insulating body can easily realize the electrical connection between the first outer surface and the inner surface of the connecting channel. A hole circuit is destroyed, improving the durability of the circuit.
  • the first surface circuit, the first hole circuit, the first electrical connection contact and the second electrical connection contact are conductive films.
  • the beneficial effect of this technical solution is that: a variety of coating processes can be used to form a conductive film, and the conductive film can be used to construct the first surface circuit, the first hole circuit, the first electrical connection contact and the second electrical connection contact, which is convenient for large-scale production , and improve product consistency.
  • the present application also provides a connection device for electrical nerve stimulation equipment, including a connection module and a feedthrough module, the connection module being any one of the above connection modules;
  • the feedthrough module includes a second insulating body and a set A plurality of third electrical connection contacts, a fourth electrical connection contact and a plurality of second circuits on the second insulating body, each of the third electrical connection contacts is electrically connected through at least one second circuit At least one fourth electrical connection contact; when the connection module and the feedthrough module are electrically connected, each of the third electrical connection contacts is electrically connected to at least one second electrical connection contact.
  • the feedthrough module is used as an intermediate module to realize the electrical connection between the circuit in the nerve electrical stimulation device and the connection module, so that the electrical connection is modularized, and it is convenient to realize standardized production.
  • the electrical connection between the third electrical connection contact and the second electrical connection contact is gold wire welding.
  • gold wire welding can realize automatic production, improve production efficiency, improve production standardization level, reduce production cost, improve product consistency, and the electrical connection mode of gold wire welding is more stable than wire welding reliable.
  • the second insulating body includes a plurality of second hole structures, the second hole structures penetrate the first surface and the second surface of the second insulating body, and the third electrical connection The contact point is arranged on the first surface of the second insulating body, the fourth electrical connection contact is arranged on the second surface of the second insulating body, and the second circuit includes The second surface circuit on the first surface of the first surface and the second hole circuit arranged in the second hole structure, the second surface circuit is electrically connected to the third electrical connection contact and the second hole circuit, the first The two-hole circuit is electrically connected to the fourth electrical connection contact.
  • the beneficial effect of this technical solution is that the setting of the second hole structure can easily realize the electrical connection between the first surface and the second surface compared with simply setting the circuit on the surface of the second insulating body.
  • the hole circuit has a certain protection and position-limiting function, which prevents the second hole circuit from being damaged and improves the durability of the circuit.
  • the present application also provides an electrical nerve stimulation device, including a device body and any one of the above connection modules; or, including a device body and any one of the above connection devices.
  • Fig. 1 is a schematic structural diagram of a nerve electrical stimulation device in the prior art
  • FIG. 2 is a schematic cross-sectional view of a partial structure of a channel connection block of a nerve electrical stimulation device in the prior art
  • FIG. 3 is a schematic cross-sectional structure diagram of a connection module of a nerve electrical stimulation device provided in an embodiment of the present application
  • Fig. 4 is a schematic cross-sectional structural diagram of a connection module of another electrical nerve stimulation device provided in an embodiment of the present application;
  • FIG. 5 is a schematic diagram of a first perspective view of a first insulating component provided by an embodiment of the present application.
  • Fig. 6 is a schematic diagram of a second viewing angle of a first insulating component provided by an embodiment of the present application.
  • Fig. 7 is a schematic diagram of a second insulating component provided by the embodiment of the present application.
  • FIG. 8 is a schematic diagram of a first perspective view of a feedthrough module provided by an embodiment of the present application.
  • FIG. 9 is a schematic diagram of a second viewing angle of a feedthrough module provided by an embodiment of the present application.
  • Fig. 10 is a schematic diagram of an electrical connection method between a third electrical connection contact and a second electrical connection contact provided by an embodiment of the present application;
  • Fig. 11 is a schematic structural diagram of a nerve electrical stimulation device provided in an embodiment of the present application.
  • Connection module 201. First insulating body; 202. First outer surface; 203. Connection channel; 204. First electrical connection contact; 205. Second electrical connection contact; 206. First circuit; 207. Elastic electrical connector; 208, metal spring ring;
  • Plug terminal 301. Plug contact;
  • the first insulating component 401.
  • the arc groove 402.
  • the first hole structure 403.
  • the existing connection assembly 10 of the electrical nerve stimulation device is separate, and is assembled by selecting a corresponding number of channel connection blocks according to the number of channel connection blocks required during assembly For example, if 4 channels are required, 4 channel connecting blocks are selected and assembled.
  • the channel connecting block is at least composed of a spring ring 101, an insulating ring 102 and a metal ring 103, and the metal ring 103 and the spring ring 101 are in contact for conduction.
  • the connection between the channel connection block of the electrical nerve stimulation device and the main board is connected by feedthrough leads 104 .
  • the spring coil 101, the insulating ring 102 and the metal ring 103 constitute the channel connection block, and the insertion end 30 of the electrode wire is installed into the inside of the channel connection block, and a plurality of contacts on the insertion end 30 Contact with the spring coil 101 to realize electrical connection, and continue to communicate with the metal ring 103 in contact with the spring coil 101 and other circuits electrically connected to the metal ring 103, and finally realize the electrical connection between the circuit in the nerve electrical stimulation device and the nerve electrical stimulation electrode .
  • a plurality of alternating insulating rings 102 and metal rings 103 are assembled to form a channel connection block, which makes the channel connection block larger in size, causing greater trauma to patients, and inconvenient production and assembly, resulting in assembly errors and poor product consistency. question
  • the feedthrough lead 104 needs to be bent to be welded together with the metal ring 103 in the channel connection block.
  • the channel connection block should also have sufficient volume. The problem that the channel connecting block is bulky and the welding is not easy to operate occurs.
  • connection module 20 of electrical nerve stimulation equipment which is used for electrical connection with electrode wires, and one end of the electrode wires is connected to the electrical nerve stimulation equipment through the connection module 20, and the electrodes The other end of the wire is connected to an electrode.
  • the connection module 20 may include: a first insulating body 201, the first insulating body 201 has a first outer surface 202 and a connection channel 203, the connection channel 203 is used to install the plug-in terminal 30 of the electrode wire, the A plurality of first electrical connection contacts 204 are arranged in the connection channel 203, and the first electrical connection contacts 204 are used to electrically connect with the plug contacts 301 of the electrode wires; the connection module 20 also includes: a plurality of The second electrical connection contact 205, a plurality of first circuits 206; each of the second electrical connection contacts 205 is arranged on the first outer surface 202, and is electrically connected to the first circuit 206 respectively. An electrical connection contact 204 .
  • FIG. 3 for the convenience of illustration, the number of the first electrical connection contact 204, the second electrical connection contact 205, and the first circuit 206 is only shown as one, and FIG. 3 is only a schematic diagram, wherein The number of components is not limited to the scope of the present application. In other embodiments, the number of the first electrical connection contact 204 , the second electrical connection contact 205 and the first circuit 206 can be respectively set to be more.
  • the electrical connection contact only refers to the electrical contact position for realizing electrical connection, and is not limited to a specific point-like structure.
  • a raised structure may be additionally provided on the first outer surface 202,
  • the protruding structure is electrically connected to the first circuit 206, and the protruding structure can be welded with a wire to realize electrical connection.
  • the protruding structure can be used as the second electrical connection contact 205, or no additional protruding structure is provided.
  • the first circuit 206 is extended or extended to a part, and this part can be welded or overlapped with the conductor to realize electrical connection, then the extension or extension can be used as the second electrical connection contact 205, or Yes, a part of the first circuit 206 extends in the connection channel 203, and this part can directly contact with multiple contacts on the electrode wire insertion end 30 or indirectly contact through an intermediate conductive part (such as a metal spring coil 208) to realize electrical connection , then the extension of the first circuit 206 in the connection channel 203 can serve as the first electrical connection contact 204 .
  • an intermediate conductive part such as a metal spring coil 208
  • the first electrical connection contact 204, the first circuit 206 and the second electrical connection contact 205 are arranged on the first insulating body 201, replacing the structure of the insulating ring 102 and the metal ring 103 alternately in the prior art, Realize the function of electrical connection with the electrode lead.
  • the connection module 20 in this technical solution has a compact structure, small volume, less trauma to the patient, and does not need to assemble the insulating ring 102 and the metal ring 103, saving procedures and having no assembly errors. The consistency of the product is good.
  • connection module 20 may further include a plurality of elastic electrical connectors 207, and the plurality of elastic electrical connectors 207 are arranged inside the connection channel 203 and along the connection
  • the channels 203 are arranged in a straight line along the length direction, and each of the elastic electrical connectors 207 is respectively electrically connected to one of the first electrical connection contacts 204 and is respectively used for electrical connection to a plug contact 301 of the electrode lead.
  • the first electrical connection contact 204 is electrically connected to a contact on the insertion end 30 of the electrode lead by using the elastic electrical connection 207, and the elastic electrical connection 207 has elasticity, so that the first electrical connection 204 and The electrical connection of a contact on the plug end 30 of the electrode lead is more stable.
  • the elastic electrical connector 207 may be a metal spring ring 208
  • the metal spring ring 208 is, for example, a canted coil spring
  • a plurality of the metal spring rings 208 are used to be socketed on On the multiple plug contacts 301 of the plug end 30 of the electrode lead.
  • the metal spring ring 208 and the plug-in contact point 301 of the electrode lead can be in annular contact, and the electrical contact is more stable. , to prevent the insertion end 30 from detaching from the connection channel 203 , which can enhance the installation stability of the insertion end 30 .
  • the first insulating body 201 is at least composed of a first insulating component 40 and a second insulating component 50, and the first insulating component 40 and/or
  • the material of the second insulating component 50 may include ceramics or plastic;
  • the first insulating component 40 and the second insulating component 50 may include a plurality of arc-shaped grooves 401 linearly arranged along the length direction of the connecting channel 203, when the When the first insulating component 40 and the second insulating component 50 are combined to form the first insulating body 201, at least part of the structure of the metal spring ring 208 is accommodated in the arc-shaped groove 401; the first electrical connection
  • the contact point 204 is disposed on at least a part of the surface inside the arc-shaped groove 401 abutting against the metal spring ring 208 .
  • the preferred ceramic material is bioceramic or composite bioceramic material and coating bioceramic material, such as using titanium alloy as the substrate, and spraying the entire outer surface A coating bioceramic material formed by a bioceramic coating;
  • the material of the first insulating component 40 or the second insulating component 50 includes plastic, it is preferably PEEK material, which has high temperature resistance, self-lubricating, easy processing and high mechanical properties. The advantage of strength can facilitate the processing and molding of the first insulating component 40 and the second insulating component 50 , and at the same time, the higher mechanical strength improves the service life of the electrical nerve stimulation device.
  • the first insulating body 201 is combined by using the split structure, which makes the manufacture of the first insulating body 201 more convenient, and at the same time, it is also convenient to construct the first electrical connection contact 204 and the first circuit on the first insulating body 201. 206, and it is convenient to assemble the metal spring ring 208 into the first channel; a plurality of arc-shaped grooves 401 have a limiting effect on the metal spring ring 208, making the installation and electrical contact of the metal spring ring 208 more stable and reliable.
  • the first insulating body 201 may include a plurality of first hole structures 402 , and the first hole structures 402 communicate with the first outer surface 202 and the connecting channel 203 , the first circuit 206 includes a first surface circuit 403 disposed on the first outer surface 202 of the first insulating body 201 and a first hole circuit (not shown, The same below); the first surface circuit 403 is electrically connected to the second electrical connection contact 205 and the first hole circuit, and the first hole circuit is electrically connected to the first electrical connection contact 204 .
  • the first hole circuit can be formed by filling the hole with conductive material, or by electroplating a conductive layer in the hole.
  • the first surface circuit 403 is constructed on the first insulating body 201, and the first hole structure 402 is provided, and the first hole circuit is constructed by using the first hole structure 402 to realize the above-mentioned electrical connection.
  • Setting the circuit on the surface of the first insulating body 201 can conveniently realize the electrical connection between the first outer surface 202 and the inner surface of the connecting channel 203, and at the same time, the first hole structure 402 has a certain protection and limiting effect on the first hole circuit , to avoid the damage of the first hole circuit and improve the durability of the circuit.
  • the first surface circuit 403, the first hole circuit, the first electrical connection contact 204 and the second electrical connection contact 205 may be conductive films.
  • the conductive film can utilize a coating process, such as electroplating, magnetron sputtering, CVD and other processes to realize the construction of a film circuit on the first insulating body 201, as the first surface circuit 403, the first hole circuit, and the first electrical connection contact.
  • a coating process such as electroplating, magnetron sputtering, CVD and other processes to realize the construction of a film circuit on the first insulating body 201, as the first surface circuit 403, the first hole circuit, and the first electrical connection contact.
  • the above-mentioned membrane circuit can be formed by electroplating, the electroplating method has low cost, large production capacity, and high bonding force between the membrane circuit and the first insulating body 201; further preferably, electroplating
  • the types include electroplated gold or electroplated titanium or a combination of both.
  • various coating techniques can be used to form a conductive film, and the conductive film is used to construct the first surface circuit 403, the first hole circuit, the first electrical connection contact 204 and the second electrical connection contact 205, which is convenient for large-scale production, and Improve product consistency.
  • connection device for electrical nerve stimulation equipment including a connection module 20 and a feedthrough module 60 as shown in FIG. 8 and FIG. 9
  • connection module 20 is the connection module provided in any of the above-mentioned embodiments 20.
  • the feedthrough module 60 includes a second insulating body 601 and a plurality of third electrical connection contacts 602, fourth electrical connection contacts 603 and a plurality of second circuits 604 arranged on the second insulating body 601, each Each of the third electrical connection contacts 602 is electrically connected to at least one of the fourth electrical connection contacts 603 through at least one second circuit 604; when the connection module 20 and the feedthrough module 60 are electrically connected, each Each of the third electrical connection contacts 602 is electrically connected to at least one of the second electrical connection contacts 205 respectively.
  • the feedthrough module 60 as an intermediate module, the electrical connection between the circuit in the electrical nerve stimulation device and the connection module 20 is realized, making the electrical connection module 20, which facilitates the realization of standardized production.
  • the electrical connection between the third electrical connection contact 602 and the second electrical connection contact 205 is gold wire welding.
  • FIG. 10 The method of gold wire welding is shown in FIG. 10 , wherein the third electrical connection contact 602 and the second electrical connection contact 205 are connected by welding gold wire 70 .
  • gold wire welding can realize automatic production, improve production efficiency, improve production standardization level, reduce production cost, and improve product consistency. Moreover, the electrical connection method of gold wire welding is more stable and reliable than wire welding.
  • the second insulating body 601 includes a plurality of second hole structures 605 , and the second hole structures 605 penetrate the first surface 606 of the second insulating body 601 and the second surface 607, the third electrical connection contact 602 is arranged on the first surface 606 of the second insulating body 601, and the fourth electrical connection contact 603 is arranged on the first surface 606 of the second insulating body 601.
  • the second circuit 604 includes a second surface circuit 608 disposed on the first surface 606 of the second insulating body 601 and a second hole circuit (not shown) disposed in the second hole structure 605 Out, the same below), the second surface circuit 608 is electrically connected to the third electrical connection contact 602 and the second hole circuit, and the second hole circuit is electrically connected to the fourth electrical connection contact 603 .
  • the second hole circuit can be formed by filling the hole with conductive material, or by electroplating a conductive layer in the hole.
  • the setting of the second hole structure 605 can conveniently realize the electrical connection between the first surface 606 and the second surface 607 compared with simply setting the circuit on the surface of the second insulating body 601.
  • the second hole structure 605 is for the second
  • the hole circuit has a certain protection and position-limiting function, which prevents the second hole circuit from being damaged and improves the durability of the circuit.
  • the present application also provides a nerve electrical stimulation device, which includes a device body 80 and the connection module 20 provided in any of the above embodiments; or, includes the device body 80 and the connection device provided in any of the above embodiments.
  • Electrical nerve stimulation devices are, for example, pulse generators.
  • connection module 20 Due to the use of the above connection module 20, the size of the nerve electrical stimulation device is reduced, and the consistency of the product is improved, so that it can be better applied to a large number of patients who need electrical nerve stimulation.
  • the above are only preferred embodiments of the present application, and are not intended to limit the present application. It should be pointed out that for those of ordinary skill in the art, some improvements and modifications can be made without departing from the technical principle of the present application. , these improvements and modifications should also be considered as the protection scope of the present application.

Abstract

一种神经电刺激设备及其连接模块(20)和连接装置,连接模块(20)用于与电极导线电连接,连接模块(20)包括:第一绝缘本体(201),第一绝缘本体(201)具有第一外表面(202)和连接通道(203),连接通道(203)用于安装电极导线的插接端(30),连接通道(203)内设置有多个第一电连接触点(204),第一电连接触点(204)用于与电极导线的插接端(30)上的插接触点(301)电连接;连接模块(20)还包括:多个第二电连接触点(205)、多个第一电路(206);每个第二电连接触点(205)设置于第一外表面(202),并分别通过第一电路(206)电连接第一电连接触点(204)。替代现有技术中相互交替的绝缘环(102)和金属环(103)的结构,使得连接模块(20)结构紧凑,体积小,对患者的创伤更小,且无需进行绝缘环(102)和金属环(103)的组装,节省工序,没有装配误差,产品的一致性好。

Description

神经电刺激设备及其连接模块和连接装置 技术领域
本申请涉及神经电刺激医疗设备技术领域,尤其涉及一种神经电刺激设备及其连接模块和连接装置。
背景技术
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。
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。
中国发明专利CN111744110A公开了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,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布置。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。
但现有技术中,神经电刺激设备(CN111744110A中的脉冲发生器)的连接模块(CN111744110A中的电极连接装置)包括相互交替的绝缘环和金属环(CN111744110A中的连接器301)组装而成的连接通道,脉冲发生器中的电路与连接模块的电连接往往采用引线连接的方式,使得连接模块的体积较大,给患者带来较大创伤,并且生产组装不方便,产生装配误差,导致产品一致性差的问题。
发明内容
本申请的目的在于提供一种神经电刺激设备及其连接模块和连接装置,解决 现有技术中神经电刺激设备的连接模块的体积较大,给患者带来较大创伤,并且生产组装不方便,产生装配误差,导致产品一致性差的问题。
本申请的目的通过以下技术方案实现:
第一方面,本申请提供一种神经电刺激设备的连接模块,用于与电极导线电连接,所述连接模块包括:第一绝缘本体,所述第一绝缘本体具有第一外表面和连接通道,所述连接通道用于安装电极导线的插接端,所述连接通道内设置有多个第一电连接触点,所述第一电连接触点用于与所述电极导线的插接端上的插接触点电连接;所述连接模块还包括:多个第二电连接触点、多个第一电路;每个所述第二电连接触点设置于所述第一外表面,并分别通过所述第一电路电连接所述第一电连接触点。
该技术方案的有益效果在于:在第一绝缘本体上设置第一电连接触点、第一电路和第二电连接触点,替代现有技术中相互交替的绝缘环和金属环的结构,实现与电极导线电连接的功能,该技术方案中的连接模块结构紧凑,体积小,对患者的创伤更小,且无需进行绝缘环和金属环的组装,节省工序,没有装配误差,产品的一致性好。
在一些可选实施例中,所述连接模块还包括多个弹性电连接件,多个所述弹性电连接件设置于所述连接通道的内部,并沿所述连接通道长度方向直线排列,每个所述弹性电连接件分别与一个所述第一电连接触点电连接并分别用于与所述电极导线的插接端上的一个插接触点电连接。该技术方案的有益效果在于:利用弹性电连接件实现第一电连接触点与电极导线的插接端上的一个触点电连接,弹性电连接件具有弹性,使得第一电连接触点与电极导线的插接端上的一个触点的电连接更加稳定。
在一些可选实施例中,所述弹性电连接件为金属弹簧圈,所述金属弹簧圈用于套接在所述电极导线的插接端的多个插接触点上。该技术方案的有益效果在于:金属弹簧圈与电极导线的插接端上的插接触点可以进行环形接触,电接触更加稳定,同时,金属弹簧圈套接电极导线的插接端,对插接端具有限位作用,能够增强插接端安装的稳定性。
在一些可选实施例中,所述第一绝缘本体至少由第一绝缘组件和第二绝缘组件组合而成,所述第一绝缘组件和/或第二绝缘组件的材质包括陶瓷或塑胶;所 述第一绝缘组件和第二绝缘组件包括沿所述连接通道长度方向直线排列的多个弧形凹槽,当所述第一绝缘组件和第二绝缘组件组合形成所述第一绝缘本体时,所述金属弹簧圈的至少部分结构容置于所述弧形凹槽内;所述第一电连接触点设置于所述弧形凹槽内部的至少与所述金属弹簧圈相抵接的部分表面。该技术方案的有益效果在于:利用分体结构组合成为第一绝缘本体,使得第一绝缘本体的制造更为方便,同时,也方便在第一绝缘本体上构建第一电连接触点和第一电路,以及方便将金属弹簧圈组装进入第一通道中;多个弧形凹槽对于金属弹簧圈具有限位作用,使得金属弹簧圈的安装和电接触更加稳固牢靠。
在一些可选实施例中,所述第一绝缘本体包括多个第一孔结构,所述第一孔结构连通所述第一外表面和连接通道,所述第一电路包括设置于所述第一绝缘本体的第一外表面的第一表面电路和设置于所述第一孔结构中的第一孔电路;所述第一表面电路电连接所述第二电连接触点和所述第一孔电路,所述第一孔电路电连接所述第一电连接触点。该技术方案的有益效果在于:在第一绝缘本体上构建第一表面电路,并设置第一孔结构,利用第一孔结构构建第一孔电路用以实现上述电连接,孔结构的设置比起单纯设置第一绝缘本体表面的电路,可以方便的实现第一外表面和连接通道的内表面的电连接,同时,第一孔结构对于第一孔电路具有一定的保护和限位作用,避免第一孔电路被破坏,提高了电路的耐久性。
在一些可选实施例中,所述第一表面电路、第一孔电路、第一电连接触点和第二电连接触点为导电膜。该技术方案的有益效果在于:可以利用多种镀膜工艺形成导电膜,利用导电膜构建第一表面电路、第一孔电路、第一电连接触点和第二电连接触点,便于规模化生产,并提高产品的一致性。
第二方面,本申请还提供一种神经电刺激设备的连接装置,包括连接模块和馈通模块,所述连接模块为上述任一项连接模块;所述馈通模块包括第二绝缘本体和设置于第二绝缘本体上的多个第三电连接触点、第四电连接触点和多个第二电路,每个所述第三电连接触点分别通过至少一个所述第二电路电连接至少一个所述第四电连接触点;当所述连接模块和馈通模块电连接时,每个所述第三电连接触点分别与至少一个所述第二电连接触点电连接。该技术方案的有益效果在于:利用馈通模块作为中间模块,实现神经电刺激设备内的电路与连接模块的电连接,使得电连接模块化,便于实现标准化生产。
在一些可选实施例中,所述第三电连接触点与所述第二电连接触点的电连接方式为金线焊接。该技术方案的有益效果在于:金线焊接能够实现自动化生产,提高生产效率,提高生产标准化水平,降低生产成本,提高产品一致性,并且,金线焊接的电连接方式相比于导线焊接更加稳定牢靠。
在一些可选实施例中,所述第二绝缘本体包括多个第二孔结构,所述第二孔结构贯穿所述第二绝缘本体的第一表面和第二表面,所述第三电连接触点设置于所述第二绝缘本体的第一表面,所述第四电连接触点设置于所述第二绝缘本体的第二表面,所述第二电路包括设置于所述第二绝缘本体的第一表面的第二表面电路和设置于所述第二孔结构中的第二孔电路,所述第二表面电路电连接所述第三电连接触点和第二孔电路,所述第二孔电路电连接所述第四电连接触点。该技术方案的有益效果在于:第二孔结构的设置比起单纯设置第二绝缘本体表面的电路,可以方便的实现第一表面和第二表面的电连接,同时,第二孔结构对于第二孔电路具有一定的保护和限位作用,避免第二孔电路被破坏,提高了电路的耐久性。
第三方面,本申请还提供一种神经电刺激设备,包括设备主体和上述任一项连接模块;或者,包括设备主体和上述任一项连接装置。
上述说明仅是本申请技术方案的概述,为了能够更清楚了解本申请的技术手段,并可依照说明书的内容予以实施,以下以本申请的较佳实施例并配合详细附图说明如后。
附图说明
图1为现有技术中的一种神经电刺激设备结构示意图;
图2为现有技术中的一种神经电刺激设备的通道连接块的部分结构剖视示意图;
图3为本申请实施例提供的一种神经电刺激设备的连接模块剖面结构示意图;
图4为本申请实施例提供的另一种神经电刺激设备的连接模块剖面结构示意图;
图5为本申请实施例提供的一种第一绝缘组件的第一视角示意图;
图6为本申请实施例提供的一种第一绝缘组件的第二视角示意图;
图7为本申请实施例提供的一种第二绝缘组件的示意图;
图8为本申请实施例提供的一种馈通模块的第一视角示意图;
图9为本申请实施例提供的一种馈通模块的第二视角示意图;
图10为本申请实施例提供的一种第三电连接触点与第二电连接触点的电连接方式示意图;
图11为本申请实施例提供的一种神经电刺激设备结构示意图。
图中:
10、现有连接组件;101、弹簧圈;102、绝缘环;103、金属环;104、馈通引线;
20、连接模块;201、第一绝缘本体;202、第一外表面;203、连接通道;204、第一电连接触点;205、第二电连接触点;206、第一电路;207、弹性电连接件;208、金属弹簧圈;
30、插接端;301、插接触点;
40、第一绝缘组件;401、弧形凹槽;402、第一孔结构;403、第一表面电路;
50、第二绝缘组件;
60、馈通模块;601、第二绝缘本体;602、第三电连接触点;603、第四电连接触点;604、第二电路;605、第二孔结构;606、第一表面;607、第二表面;608、第二表面电路
70、焊接金线;
80、设备主体。
具体实施方式
下面结合图表和实施例,对本申请的具体实施方式作进一步详细描述。以下实施例用于说明本申请,但不用来限制本申请的范围。
参见图1和图2,在现有技术中,神经电刺激设备的现有连接组件10是单独的,在装配中根据需求通道连接块数量的多少,选择相应的数量的通道连接块组装而成,例如需求4通道就选择4个通道连接块组装而成,通道连接块至少由弹簧圈101、绝缘环102和金属环103组成,通过金属环103和弹簧圈101接触进行导通。神经电刺激设备的通道连接块与主板的连接依靠馈通引线104连接。
参见图2,在现有技术中,弹簧圈101、绝缘环102和金属环103构成通道连接块,电极导线的插接端30安装进入通道连接块内部,插接端30上的多个触点分别与弹簧圈101接触以实现电连接,并继续连通与弹簧圈101接触的金属环103以及电连接金属环103的其他电路,最终实现神经电刺激设备内的电路和神经电刺激电极的电连接。多个交替的绝缘环102和金属环103组装而成通道连接块,使得通道连接块的体积较大,给患者带来较大创伤,并且生产组装不方便,产生装配误差,导致产品一致性差的问题
另外,在实际应用中,馈通引线104需要弯折,才能和通道连接块中的金属环103焊接在一起,为了保证馈通引线104的弯折强度,需要给馈通引线104足够的空间,并且为了便于焊接,通道连接块也要有足够的体积。产生通道连接块体积大,焊接不容易操作的问题。
参加图3,为解决上述技术问题,本申请实施例提供一种神经电刺激设备的连接模块20,用于与电极导线电连接,电极导线的一端通过连接连接模块20连接神经电刺激设备,电极导线的另一端连接电极。
所述连接模块20可以包括:第一绝缘本体201,所述第一绝缘本体201具有第一外表面202和连接通道203,所述连接通道203用于安装电极导线的插接端30,所述连接通道203内设置有多个第一电连接触点204,所述第一电连接触点204用于与所述电极导线的插接触点301电连接;所述连接模块20还包括:多个第二电连接触点205、多个第一电路206;每个所述第二电连接触点205设置于所述第一外表面202,并分别通过所述第一电路206电连接所述第一电连接触点204。
需要说明的是,在图3中,为展示方便,第一电连接触点204、第二电连接触点205和第一电路206的数量均仅示出1个,图3仅作为示意图,其中的部件数量并非对本申请范围的限制,在其他实施方式中,第一电连接触点204、第二电连接触点205和第一电路206的数量还可以分别设置更多个。
其中,在本申请中,所述电连接触点仅代指实现电连接的电接触位置,并非限定为一个特定的点状结构,例如是,可以在第一外表面202额外设置凸起结构,该凸起结构与第一电路206电连接,该凸起结构可以与导线进行焊接以实现电连接,此时,该凸起结构可以作为第二电连接触点205,或者是,不额外设置凸起 结构,而是将第一电路206继续延伸或扩展一部分,该部分可以与导体进行焊接或搭接以实现电连接,则该延伸部或扩展部可以作为第二电连接触点205,亦或是,第一电路206在连接通道203内延伸一部分,该部分可以与电极导线插接端30上的多个触点直接接触或通过中间导电部件(例如金属弹簧圈208)间接接触,实现电连接,则该第一电路206在连接通道203内的延伸部可以作为第一电连接触点204。
由此,在第一绝缘本体201上设置第一电连接触点204、第一电路206和第二电连接触点205,替代现有技术中相互交替的绝缘环102和金属环103的结构,实现与电极导线电连接的功能,该技术方案中的连接模块20结构紧凑,体积小,对患者的创伤更小,且无需进行绝缘环102和金属环103的组装,节省工序,没有装配误差,产品的一致性好。
参见图4,在一些实施方式中,所述连接模块20还可以包括多个弹性电连接件207,多个所述弹性电连接件207设置于所述连接通道203的内部,并沿所述连接通道203长度方向直线排列,每个所述弹性电连接件207分别与一个所述第一电连接触点204电连接并分别用于与所述电极导线的一个插接触点301电连接。由此,利用弹性电连接件207实现第一电连接触点204与电极导线的插接端30上的一个触点电连接,弹性电连接件207具有弹性,使得第一电连接触点204与电极导线的插接端30上的一个触点的电连接更加稳定。
继续参见图4,在一些实施方式中,所述弹性电连接件207可以为金属弹簧圈208,金属弹簧圈208例如是斜圈弹簧,多个所述金属弹簧圈208用于一一套接在所述电极导线的插接端30的多个插接触点301上。由此,金属弹簧圈208与电极导线的插接触点301可以进行环形接触,电接触更加稳定,同时,金属弹簧圈208套接电极导线的插接端30,对插接端30具有限位作用,防止插接端30脱离连接通道203,能够增强插接端30安装的稳定性。
参见图5、图6和图7,在一些实施方式中,所述第一绝缘本体201至少由第一绝缘组件40和第二绝缘组件50组合而成,所述第一绝缘组件40和/或第二绝缘组件50的材质可以包括陶瓷或塑胶;所述第一绝缘组件40和第二绝缘组件50可以包括沿所述连接通道203长度方向直线排列的多个弧形凹槽401,当所述第一绝缘组件40和第二绝缘组件50组合形成所述第一绝缘本体201时,所述金 属弹簧圈208的至少部分结构容置于所述弧形凹槽401内;所述第一电连接触点204设置于所述弧形凹槽401内部的至少与所述金属弹簧圈208相抵接的部分表面。
其中,当第一绝缘组件40或第二绝缘组件50的材质包括陶瓷时,优选的陶瓷材料为生物陶瓷或复合生物陶瓷材料以及涂层生物陶瓷材料,例如利用钛合金作为基体,全部外表面喷涂生物陶瓷涂层所形成的涂层生物陶瓷材料;当第一绝缘组件40或第二绝缘组件50的材质包括塑胶时,优选采用PEEK材料,PEEK材料具有耐高温、自润滑、易加工和高机械强度的优点,能够方便第一绝缘组件40和第二绝缘组件50的加工成型,同时较高的机械强度提高了神经电刺激设备的使用寿命。
由此,利用分体结构组合成为第一绝缘本体201,使得第一绝缘本体201的制造更为方便,同时,也方便在第一绝缘本体201上构建第一电连接触点204和第一电路206,以及方便将金属弹簧圈208组装进入第一通道中;多个弧形凹槽401对于金属弹簧圈208具有限位作用,使得金属弹簧圈208的安装和电接触更加稳固牢靠。
继续参见图5和图6,在一些实施方式中,所述第一绝缘本体201可以包括多个第一孔结构402,所述第一孔结构402连通所述第一外表面202和连接通道203,所述第一电路206包括设置于所述第一绝缘本体201的第一外表面202的第一表面电路403和设置于所述第一孔结构402中的第一孔电路(未示出,下同);所述第一表面电路403电连接所述第二电连接触点205和所述第一孔电路,所述第一孔电路电连接所述第一电连接触点204。
其中,第一孔电路可以利用孔中填塞导电材料的方法形成,也可以利用孔中电镀导电层的方法形成。
由此,在第一绝缘本体201上构建第一表面电路403,并设置第一孔结构402,利用第一孔结构402构建第一孔电路用以实现上述电连接,孔结构的设置比起单纯设置第一绝缘本体201表面的电路,可以方便的实现第一外表面202和连接通道203的内表面的电连接,同时,第一孔结构402对于第一孔电路具有一定的保护和限位作用,避免第一孔电路被破坏,提高了电路的耐久性。
在一些实施方式中,所述第一表面电路403、第一孔电路、第一电连接触点 204和第二电连接触点205可以为导电膜。
其中,导电膜可以利用镀膜工艺,例如电镀、磁控溅射、CVD等工艺实现在第一绝缘本体201上构建膜电路,作为第一表面电路403、第一孔电路、第一电连接触点204和第二电连接触点205,优选的,可以利用电镀的方法形成上述膜电路,电镀的方法成本低,产能大,膜电路与第一绝缘本体201的结合力高;进一步优选的,电镀的种类包括电镀金或电镀钛或两者的组合。
由此,可以利用多种镀膜工艺形成导电膜,利用导电膜构建第一表面电路403、第一孔电路、第一电连接触点204和第二电连接触点205,便于规模化生产,并提高产品的一致性。
本申请实施例还提供一种神经电刺激设备的连接装置,包括连接模块20和如图8及图9所示的馈通模块60,所述连接模块20为上述任一实施例提供的连接模块20;所述馈通模块60包括第二绝缘本体601和设置于第二绝缘本体601上的多个第三电连接触点602、第四电连接触点603和多个第二电路604,每个所述第三电连接触点602分别通过至少一个所述第二电路604电连接至少一个所述第四电连接触点603;当所述连接模块20和馈通模块60电连接时,每个所述第三电连接触点602分别与至少一个所述第二电连接触点205电连接。由此,利用馈通模块60作为中间模块,实现神经电刺激设备内的电路与连接模块20的电连接,使得电连接模块20化,便于实现标准化生产。
在一些实施方式中,所述第三电连接触点602与所述第二电连接触点205的电连接方式为金线焊接。
金线焊接的方式例如图10所示,其中,利用焊接金线70连接第三电连接触点602与第二电连接触点205。
由此,金线焊接能够实现自动化生产,提高生产效率,提高生产标准化水平,降低生产成本,提高产品一致性,并且,金线焊接的电连接方式相比于导线焊接更加稳定牢靠。
继续参见图8和图9,在一些实施方式中,所述第二绝缘本体601包括多个第二孔结构605,所述第二孔结构605贯穿所述第二绝缘本体601的第一表面606和第二表面607,所述第三电连接触点602设置于所述第二绝缘本体601的第一表面606,所述第四电连接触点603设置于所述第二绝缘本体601的第二表面 607,所述第二电路604包括设置于所述第二绝缘本体601的第一表面606的第二表面电路608和设置于所述第二孔结构605中的第二孔电路(未示出,下同),所述第二表面电路608电连接所述第三电连接触点602和第二孔电路,所述第二孔电路电连接所述第四电连接触点603。
其中,第二孔电路可以利用孔中填塞导电材料的方法形成,也可以利用孔中电镀导电层的方法形成。
由此,第二孔结构605的设置比起单纯设置第二绝缘本体601表面的电路,可以方便的实现第一表面606和第二表面607的电连接,同时,第二孔结构605对于第二孔电路具有一定的保护和限位作用,避免第二孔电路被破坏,提高了电路的耐久性。
本申请还提供还一种神经电刺激设备,包括设备主体80和上述任一实施例中提供的连接模块20;或者,包括设备主体80和上述任一实施例提供的连接装置。神经电刺激设备例如是脉冲发生器。
由于采用了上述连接模块20,使得该神经电刺激设备的体积得以缩小,同时产品的一致性得到了提高,能够更好的应用于广大神经电刺激需求患者身上。以上仅是本申请的优选实施方式,并不用于限制本申请,应当指出,对于本技术领域的普通技术人员来说,在不脱离本申请技术原理的前提下,还可以做出若干改进和变型,这些改进和变型也应视为本申请的保护范围。

Claims (10)

  1. 一种神经电刺激设备的连接模块,用于与电极导线电连接,所述连接模块包括:第一绝缘本体,所述第一绝缘本体具有第一外表面和连接通道,所述连接通道用于安装电极导线的插接端,所述连接通道内设置有多个第一电连接触点,所述第一电连接触点用于与所述电极导线的插接端上的插接触点电连接;
    其特征在于:所述连接模块还包括:多个第二电连接触点、多个第一电路;
    每个所述第二电连接触点设置于所述第一外表面,并分别通过所述第一电路电连接所述第一电连接触点。
  2. 根据权利要求1所述的连接模块,其特征在于:所述连接模块还包括多个弹性电连接件,多个所述弹性电连接件设置于所述连接通道的内部,并沿所述连接通道长度方向直线排列,每个所述弹性电连接件分别与一个所述第一电连接触点电连接并分别用于与所述电极导线的插接端上的一个插接触点电连接。
  3. 根据权利要求2所述的连接模块,其特征在于:所述弹性电连接件为金属弹簧圈,所述金属弹簧圈用于套接在所述电极导线的插接端的多个插接触点上。
  4. 根据权利要求3所述的连接模块,其特征在于:所述第一绝缘本体至少由第一绝缘组件和第二绝缘组件组合而成,所述第一绝缘组件和/或第二绝缘组件的材质包括陶瓷或塑胶;
    所述第一绝缘组件和第二绝缘组件包括沿所述连接通道长度方向直线排列的多个弧形凹槽,当所述第一绝缘组件和第二绝缘组件组合形成所述第一绝缘本体时,所述金属弹簧圈的至少部分结构容置于所述弧形凹槽内;
    所述第一电连接触点设置于所述弧形凹槽内部的至少与所述金属弹簧圈相抵接的部分表面。
  5. 根据权利要求1所述的连接模块,其特征在于:所述第一绝缘本体包括多个第一孔结构,所述第一孔结构连通所述第一外表面和连接通道;
    所述第一电路包括设置于所述第一绝缘本体的第一外表面的第一表面电路和设置于所述第一孔结构中的第一孔电路;所述第一表面电路电连接所述第二电连接触点和所述第一孔电路,所述第一孔电路电连接所述第一电连接触点。
  6. 根据权利要求5所述的连接模块,其特征在于:所述第一表面电路、第 一孔电路、第一电连接触点和第二电连接触点为导电膜。
  7. 一种神经电刺激设备的连接装置,其特征在于,包括连接模块和馈通模块,所述连接模块为权利要求1-6任一项所述的连接模块;所述馈通模块包括第二绝缘本体和设置于第二绝缘本体上的多个第三电连接触点、第四电连接触点和多个第二电路,每个所述第三电连接触点分别通过至少一个所述第二电路电连接至少一个所述第四电连接触点;当所述连接模块和馈通模块电连接时,每个所述第三电连接触点分别与至少一个所述第二电连接触点电连接。
  8. 根据权利要求7所述的连接装置,其特征在于:所述第三电连接触点与所述第二电连接触点的电连接方式为金线焊接。
  9. 根据权利要求7所述的连接装置,其特征在于:所述第二绝缘本体包括多个第二孔结构,所述第二孔结构贯穿所述第二绝缘本体的第一表面和第二表面,所述第三电连接触点设置于所述第二绝缘本体的第一表面,所述第四电连接触点设置于所述第二绝缘本体的第二表面,所述第二电路包括设置于所述第二绝缘本体的第一表面的第二表面电路和设置于所述第二孔结构中的第二孔电路,所述第二表面电路电连接所述第三电连接触点和第二孔电路,所述第二孔电路电连接所述第四电连接触点。
  10. 一种神经电刺激设备,包括设备主体和权利要求1-6任一项所述的连接模块;或者,包括设备主体和权利要求7-9任一项所述的连接装置。
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