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CN110841186B - Implanted peripheral nerve electrode - Google Patents

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CN110841186B
CN110841186B CN201911140311.7A CN201911140311A CN110841186B CN 110841186 B CN110841186 B CN 110841186B CN 201911140311 A CN201911140311 A CN 201911140311A CN 110841186 B CN110841186 B CN 110841186B
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electrode
peripheral nerve
wire
nerve
openable
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CN110841186A (en
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张鹏
李强
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Wuhan Zhongke Medical Technology Industrial Technology Research Institute Co Ltd
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Huazhong University of Science and Technology
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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
    • A61N1/0504Subcutaneous electrodes
    • 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
    • A61N1/0551Spinal or peripheral nerve electrodes
    • 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
    • A61N1/0551Spinal or peripheral nerve electrodes
    • A61N1/0558Anchoring or fixation means therefor

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Abstract

本发明公开了一种植入式外周神经电极,属于医疗器械领域。包括:电极头,电极头包括:可开合环状基体、多根电极丝和电极丝植入神经导引部分,每根电极丝固定于可开合环状基体中,其直径小于可开合环状基体的厚度,且表面覆盖绝缘层,一侧与电极丝植入神经导引部分相连,另一侧与插头端对应插孔连接;插头端,包括多个插孔,用于与神经信号采集/刺激设备相连。本发明使用可开合环状基体作为电极的基本结构,通过可开合环状基体包裹在外周神经干外部,使电极稳定地固定在外周神经表面,防止植入电极的位移。多根电极丝通过导引针头的引导植入外周神经不同位置的靶向位点,提高外周神经电极记录和刺激的空间选择性、精确性以及稳定性。

Figure 201911140311

The invention discloses an implantable peripheral nerve electrode, which belongs to the field of medical devices. Including: an electrode head, the electrode head includes: an openable and closable annular base body, a plurality of electrode wires and an electrode wire implanted nerve guiding part, each electrode wire is fixed in the openable and closeable annular base body, and its diameter is smaller than the openable and closeable annular base body. The thickness of the annular base body, and the surface is covered with an insulating layer, one side is connected with the electrode wire implanted nerve guiding part, and the other side is connected with the corresponding jack at the plug end; the plug end includes a plurality of jacks for connecting with nerve signals Connect the acquisition/stimulation device. The invention uses the openable and closable annular base as the basic structure of the electrode, and the openable and closeable annular base is wrapped outside the peripheral nerve trunk, so that the electrode is stably fixed on the surface of the peripheral nerve, and the displacement of the implanted electrode is prevented. Multiple electrode wires are implanted into target sites at different positions of the peripheral nerve through the guidance of the guiding needle, so as to improve the spatial selectivity, accuracy and stability of the recording and stimulation of the peripheral nerve electrodes.

Figure 201911140311

Description

Implanted peripheral nerve electrode
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to an implantable peripheral nerve electrode.
Background
Peripheral nerve electrodes are implanted into peripheral nerves to construct a peripheral nerve interface, so that on one hand, peripheral nerve signals can be recorded, and peripheral nerve motion control instructions are decoded to control external equipment, so that the peripheral nerve interface can be used for repairing the motion function of the disabled; on the other hand, the electric stimulation can be applied to peripheral nerves through the peripheral nerve electrodes, and the device can be used for repairing the sensory function of the disabled. In addition, peripheral nerve electrode-based electrical stimulation has also found widespread use in functional electrical stimulation as well as in vagus nerve electrical stimulation.
Although the conventional implantable peripheral nerve electrode has undergone a great deal of development and improvement, the following problems still remain: (1) the peripheral nerve electrode implanted into the peripheral nerve bundle is difficult to fix and is easy to displace to influence the use and stability of the peripheral nerve electrode; (2) the spatial selectivity of the peripheral nerve electrode is not high, and effective implantation of a plurality of specific sites on the peripheral nerve cannot be realized; (3) peripheral nerve electrodes have requirements for the size of the peripheral nerve and cannot implant small peripheral nerves.
Disclosure of Invention
Aiming at the defects and the improvement requirements of the prior art, the invention provides an implanted peripheral nerve electrode, and aims to provide an electrode which is stably implanted into peripheral nerves and has good space selectivity and an implantation method of the electrode, so that the electrode can effectively record nerve signals of peripheral nerve fibers and accurately activate the peripheral nerve fibers at different sites, and the functions of the body such as movement, sensation and the like can be repaired.
To achieve the above object, according to one aspect of the present invention, there is provided an implantable peripheral nerve electrode, the electrode comprising:
an electrode tip, the electrode tip comprising: the electrode wire is fixed in the openable ring-shaped substrate, the diameter of the electrode wire is smaller than the thickness of the openable ring-shaped substrate, the surface of the electrode wire is covered with an insulating layer, one side of the electrode wire is connected with the electrode wire implantation nerve guiding part, and the other side of the electrode wire is connected with a plug end corresponding jack;
and the plug end comprises a plurality of jacks and is used for connecting with the neural signal acquisition/stimulation equipment.
Specifically, the openable ring-shaped substrate is flexible.
Specifically, the insulating layer at the position of 5-10 mm on the side where the electrode wire is connected with the electrode wire implantation nerve guiding part is removed, and the removal length is 100-200 micrometers.
Specifically, the diameter of the electrode wire is 50-100 microns.
Specifically, the outer layer of one side of the electrode wire connected with the plug end is wrapped by a flexible protective sleeve.
Specifically, the wire electrode implantation nerve guiding part includes: the diameter of the guide wire and the guide needle is 200-300 microns.
Specifically, one side of the jack connected with the electrode wire is covered by epoxy resin.
Generally, by the above technical solution conceived by the present invention, the following beneficial effects can be obtained:
(1) the invention uses the openable ring-shaped substrate as the basic structure of the electrode, then the openable ring-shaped substrate is wrapped outside the peripheral nerve trunk, and the annular substrate and the peripheral nerve trunk can be fixed by the operation suture, so that the electrode is stably fixed on the surface of the peripheral nerve, the problem that the peripheral nerve electrode is difficult to fix is solved, and the displacement of the implanted electrode is prevented.
(2) One wire electrode in the invention is an electrode site, each wire electrode can be independently implanted into the random position of the peripheral nerve trunk, and a plurality of wire electrodes are implanted into the target sites at different positions of the peripheral nerve through the guide of the guide needle head, so that the space selectivity, the accuracy and the stability of the peripheral nerve electrode recording and stimulation are improved.
Drawings
FIG. 1 is a schematic structural diagram of an implantable peripheral nerve electrode according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a process for implanting a peripheral nerve according to an embodiment of the present invention;
the same reference numbers will be used throughout the drawings to refer to the same or like elements or structures, wherein:
1-electrode tip, 2-electrode wire, 3-plug end, 4-openable ring-shaped substrate, 5-electrode wire, 6-guide wire, 7-guide needle head, 8-protective sleeve, 9-jack, 10-peripheral nerve bundle, 11-peripheral nerve and 12-micro suture.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. In addition, the technical features involved in the embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.
As shown in fig. 1, the present invention provides an implantable peripheral nerve electrode, the electrode comprising:
an electrode head 1, said electrode head comprising: the electrode wire implanting nerve guiding device comprises an openable annular substrate 4, a plurality of electrode wires 5 and electrode wire implanting nerve guiding parts (6 and 7), wherein each electrode wire 5 is fixed in the openable annular substrate 4, the diameter of each electrode wire is smaller than the thickness of the openable annular substrate 4, the surface of each electrode wire is covered with an insulating layer, one side of each electrode wire is connected with the electrode wire implanting nerve guiding part, and the other side of each electrode wire is connected with a corresponding jack 9 of a plug end;
the plug end 3, including a plurality of jacks 9, is used for connecting with a neural signal acquisition/stimulation device.
Preferably, the openable and closable annular substrate 4 of the present invention is flexible, has a certain flexibility and good biocompatibility, and can be stably fixed on the surface of a peripheral nerve while preventing damage to the nerve.
Preferably, in the present invention, the insulating layer is removed from a side of the electrode wire 5, which is 5 mm to 10 mm away from the side where the electrode wire is connected to the electrode wire implantation nerve guiding part, and the removed length is 100 micrometers to 200 micrometers, so as to ensure the effectiveness of recording nerve signals or electrical stimulation.
If the wire electrode is too large, the nerve signal cannot be recorded effectively. Preferably, the diameter of the electrode wire in the invention is 50-100 microns. The electrode wire 5 is a stainless steel wire with an insulating layer, a platinum-iridium alloy wire, a cobalt-chromium-molybdenum alloy wire, a nickel-titanium alloy wire or a tungsten alloy wire.
Preferably, the outer layer of one side (regarded as the electrode wire 2) of the electrode wire connected with the plug end is wrapped by the flexible protective sleeve 8, so as to prevent the nerve from being damaged and protect the electrode wire inside.
Preferably, the wire electrode implantation nerve guiding part of the present invention includes: a guide wire 6 and a guide needle 7, wherein the guide wire is connected with the guide needle and is used for guiding the electrode wire to be implanted into the peripheral nerve. The diameter is too small to achieve the effect of guidance, and too large diameter may damage nerves, and it is preferable that the diameter of the guide wire and the guide needle in the present invention is 200 to 300 micrometers.
Preferably, one side of the jack, which is connected with the wire electrode, is covered by epoxy resin in a wrapping manner, so that the fixing effect is realized, and meanwhile, the connection failure of the wire electrode and the jack and tissue fluid and the like are prevented from entering the joint.
As shown in fig. 2, the method for implanting a peripheral nerve by using an implantable peripheral nerve electrode provided by the invention comprises the following steps:
1. surgically exposing the peripheral nerve 11 to be implanted;
2. wrapping the openable ring-shaped substrate 4 on the peripheral nerve 11, sewing two sides of the openable ring-shaped substrate 4 by using a microscopic suture 12 to fix the openable ring-shaped substrate, and sewing the other two sides of the openable ring-shaped substrate 4 together with the peripheral nerve 11 by using microscopic sutures respectively;
3. clamping the guide needle 7 by a needle holder, penetrating the guide needle 7 into a target position and penetrating through the peripheral nerve 11, and leading the guide needle 7 to carry the guide wire 6 and the electrode wire 5 to penetrate through the peripheral nerve 11 until the part of the electrode wire 5 stripped of the insulating layer completely enters the peripheral nerve bundle 10;
4. cutting off the electrode wire 5 part passing through the peripheral nerve 11 by using a surgical scissors, and removing the guide wire 6 and the guide needle 7 connected with the electrode wire;
5. repeating the step 3 and the step 4 until all the electrode wires are completely implanted into the peripheral nerve 11;
6. and (4) establishing a subcutaneous tunnel, and fixing the plug end 3 when the subcutaneous tunnel reaches a specific position.
It will be understood by those skilled in the art that the foregoing is only a preferred embodiment of the present invention, and is not intended to limit the invention, and that any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the scope of the present invention.

Claims (7)

1.一种植入式外周神经电极,其特征在于,所述电极包括:1. An implantable peripheral nerve electrode, wherein the electrode comprises: 电极头,所述电极头包括:可开合环状基体、多根电极丝和电极丝植入神经导引部分,每根电极丝以内嵌形式固定于可开合环状基体中,其直径小于可开合环状基体的厚度,且表面覆盖绝缘层,一侧与电极丝植入神经导引部分相连,另一侧与插头端对应插孔连接,且可开合环状基体与电极丝植入神经导引部分之间电极丝表面绝缘层移除;Electrode head, the electrode head comprises: an openable and closable annular base body, a plurality of electrode wires and an electrode wire implanted nerve guiding part, each electrode wire is fixed in the openable and closeable annular base in an inline form, and its diameter is smaller than The thickness of the openable annular base body, and the surface is covered with an insulating layer, one side is connected with the electrode wire implanted nerve guiding part, and the other side is connected with the corresponding jack at the plug end, and the openable and closeable annular base body and the electrode wire implanted Remove the insulating layer on the surface of the electrode wire between the guiding parts of the nerve; 插头端,包括多个插孔,用于与神经信号采集/刺激设备相连。The plug end, including multiple jacks, is used to connect to neural signal acquisition/stimulation equipment. 2.如权利要求1所述的植入式外周神经电极,其特征在于,所述可开合环状基体为柔性。2 . The implantable peripheral nerve electrode of claim 1 , wherein the openable and closable annular base is flexible. 3 . 3.如权利要求1所述的植入式外周神经电极,其特征在于,移除电极丝与电极丝植入神经导引部分连接的一侧5毫米~10毫米处的绝缘层,移除长度为100微米~200微米。3 . The implantable peripheral nerve electrode according to claim 1 , wherein the insulating layer at 5 mm to 10 mm on the side where the wire electrode is connected to the implanted nerve guiding part of the wire electrode is removed, and the length is removed. 4 . 100 microns to 200 microns. 4.如权利要求1所述的植入式外周神经电极,其特征在于,所述电极丝的直径为50微米~100微米。4 . The implantable peripheral nerve electrode according to claim 1 , wherein the diameter of the electrode wire is 50 μm˜100 μm. 5 . 5.如权利要求1所述的植入式外周神经电极,其特征在于,所述电极丝与插头端连接的一侧外层包裹柔性保护套。5 . The implantable peripheral nerve electrode according to claim 1 , wherein the outer layer of the side where the electrode wire is connected to the plug end is wrapped with a flexible protective sleeve. 6 . 6.如权利要求1所述的植入式外周神经电极,其特征在于,所述电极丝植入神经导引部分包括:导引线和导引针头,所述导引线和导引针头的直径为200微米~300微米。6 . The implantable peripheral nerve electrode according to claim 1 , wherein the implanted nerve guiding part of the electrode wire comprises: a guiding wire and a guiding needle; The diameter is 200 microns to 300 microns. 7.如权利要求1所述的植入式外周神经电极,其特征在于,插孔与电极丝相连的一侧用环氧树脂包裹覆盖。7 . The implantable peripheral nerve electrode according to claim 1 , wherein the side of the insertion hole connected to the electrode wire is covered with epoxy resin. 8 .
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CN113180885A (en) * 2021-04-01 2021-07-30 重庆市畜牧科学院 Optic nerve interface and its preparing method
CN113197587A (en) * 2021-04-26 2021-08-03 中国科学院深圳先进技术研究院 Device for vagus nerve stimulation and electrophysiological detection and implantation method
CN113907761B (en) * 2021-10-09 2024-05-07 中国人民解放军军事科学院军事医学研究院 Bipolar implantable myoelectric electrode assembly for stimulation and recording and application method thereof
CN119302663A (en) * 2022-06-17 2025-01-14 上海阶梯医疗科技有限公司 Flexible electrode for peripheral nerve and manufacturing method thereof
CN115154897B (en) * 2022-06-20 2024-08-09 上海阶梯医疗科技有限公司 System for assisting in implanting a wire electrode and method for guiding a wire electrode
CN117618768B (en) * 2023-11-10 2024-06-21 浙江大学 A three-dimensional flexible electrode for peripheral nerve directional spatial stimulation recording and its preparation method

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