技术领域Technical field
本发明属于医疗器械领域，尤其是涉及一种外周神经定向空间刺激记录的立体柔性电极及其制备方法。The invention belongs to the field of medical devices, and in particular relates to a three-dimensional flexible electrode for directional spatial stimulation recording of peripheral nerves and a preparation method thereof.
背景技术Background technique
目前外周神经研究中常用的电极包括包裹在神经膜外的神经膜外电极和植入于神经膜内的神经膜内电极。膜外电极主要有Cuff电极和FINE电极等，使用时可包裹在外周神经上，利用电极位点从神经膜外进行神经刺激或记录。Currently, commonly used electrodes in peripheral nerve research include epineurial electrodes wrapped outside the neuromembrane and intraneurial electrodes implanted within the neuromembrane. Extramembrane electrodes mainly include Cuff electrodes and FINE electrodes. When used, they can be wrapped around peripheral nerves and the electrode sites can be used to stimulate or record nerves from outside the neural membrane.
如公开号为CN102764479A的中国专利文献公开了一种柔性神经束电极，包括柔性基底、电极单元、电极引线、引线焊点及绝缘层，电极引线电连接电极单元和引线焊点，电极单元、电极引线及引线焊点共同组成电极组件，电极组件设于柔性基底上，绝缘层设于柔性基底上并覆盖电极引线，电极单元用于电连接神经束。For example, the Chinese patent document with publication number CN102764479A discloses a flexible nerve bundle electrode, which includes a flexible base, an electrode unit, an electrode lead, a lead solder joint, and an insulating layer. The electrode lead is electrically connected to the electrode unit and the lead solder joint. The electrode unit, the electrode The leads and lead solder joints together form an electrode assembly. The electrode assembly is located on the flexible base. The insulation layer is located on the flexible base and covers the electrode leads. The electrode unit is used to electrically connect the nerve bundles.
膜内电极主要有USEA、TIME和LIFE电极等，使用时穿透神经外膜植入到神经束中，利用电极位点对附近的神经束进行神经刺激或记录。Intra-membrane electrodes mainly include USEA, TIME and LIFE electrodes. When used, they penetrate the epineurium and are implanted into the nerve bundles, and the electrode sites are used to stimulate or record nearby nerve bundles.
如公开号为CN115054824A的中国专利文献公开了一种用于周围神经的线性式柔性电极，所述柔性电极包括植入部分和固定部分，所述植入部分的至少一部分能够被植入到周围神经束内。For example, Chinese patent document No. CN115054824A discloses a linear flexible electrode for peripheral nerves. The flexible electrode includes an implanted part and a fixed part. At least part of the implanted part can be implanted into the peripheral nerves. within the bundle.
然而，传统的膜内和膜外刺激电极在实际应用中都存在诸多局限性，如神经膜内电极植入时难以固定，容易移位甚至脱落，而神经膜外电极也存在刺激时所需电流阈值较大、难以激活深层肌肉和选择性有限等缺点，在记录时也存在信噪比较低和空间分辨率不足等问题，这些限制性因素严重制约了外周神经刺激研究的发展。However, traditional intramembranous and extramembranous stimulation electrodes have many limitations in practical applications. For example, intraneural electrodes are difficult to fix when implanted, and are easy to shift or even fall off. Extraneural electrodes also have current requirements for stimulation. Disadvantages such as large thresholds, difficulty in activating deep muscles, and limited selectivity. There are also problems such as low signal-to-noise ratio and insufficient spatial resolution during recording. These limiting factors have seriously restricted the development of peripheral nerve stimulation research.
因此，需要一种外周神经电极，既能够精确实现膜内刺激和记录，又能够保证长时间稳定固定。Therefore, there is a need for a peripheral nerve electrode that can accurately achieve intramembranous stimulation and recording and ensure stable fixation for a long time.
发明内容Contents of the invention
本发明提供了一种外周神经定向空间刺激记录的立体柔性电极及其制备方法，可以提高刺激和记录的空间定向选择性和精准性，同时也能保证电极在神经上的长时间稳定固定。The invention provides a three-dimensional flexible electrode for peripheral nerve directional spatial stimulation recording and a preparation method thereof, which can improve the spatial directional selectivity and accuracy of stimulation and recording, and at the same time ensure the long-term stable fixation of the electrode on the nerve.
一种外周神经定向空间刺激记录的立体柔性电极，包括柔性的穿植部分和包裹部分，所述的包裹部分设有与穿植部分外形相匹配的缺口；所述的穿植部分嵌入布置在缺口中，穿植部分为一端与包裹部分连接固定的条形结构，条形结构的另一端为尖状；A three-dimensional flexible electrode for peripheral nerve directional spatial stimulation recording, including a flexible implantation part and a wrapping part, the wrapping part is provided with a gap that matches the shape of the implantation part; the implantation part is embedded and arranged in the gap , the implanting part is a bar-shaped structure with one end connected and fixed to the wrapping part, and the other end of the bar-shaped structure is pointed;
所述穿植部分用于穿透神经膜内植入神经束中，所述包裹部分用于卷曲包裹固定在神经外膜上；The implanting part is used to penetrate the neural membrane and be implanted into the nerve bundle, and the wrapping part is used to curl, wrap and fix on the epineurium;
穿植部分和包裹部分均包含基底层、覆盖层以及位于基底层和覆盖层之间的导线层；穿植部分和包裹部分的覆盖层上均设有多个电极位点，分别通过对应导线层上的导线连接至电极接口；所述的电极接口与外部设备连接。Both the implanting part and the wrapping part include a base layer, a covering layer, and a conductor layer located between the base layer and the covering layer; the covering layers of the implanting part and the wrapping part are each provided with multiple electrode sites, which pass through the corresponding conductor layers. The wires on the electrode are connected to the electrode interface; the electrode interface is connected to external equipment.
本发明中，穿植部分分布有电极位点，可以用于神经膜内刺激或记录；包裹部分分布有电极位点，可以用于神经膜外刺激或记录；各部分的电极位点还可以联合配置使用，构建多种精细电流回路以适应不同的神经刺激或记录使用场景。电极位点的形状尺寸和数量可方便地根据使用需求个性化定制。In the present invention, the implanted part is distributed with electrode sites, which can be used for intraneural stimulation or recording; the wrapped part is distributed with electrode sites, which can be used for extraneural stimulation or recording; the electrode sites of each part can also be combined Configure and use to build a variety of fine current loops to adapt to different nerve stimulation or recording usage scenarios. The shape, size and number of electrode sites can be easily customized according to usage requirements.
穿植部分的电极位点在电极植入后与神经膜内的神经束接触，包裹部分的电极位点与神经外膜接触；通过穿植部分和包裹部分的电极位点分别将电流脉冲传递到神经内进行神经电刺激或者将神经信号采集到外部设备进行神经记录；或者通过对穿植部分和包裹部分的电极位点进行联合优化配置，构建精细电流环路，实现更精准的空间定向刺激和记录。After the electrode is implanted, the electrode site of the implanted part is in contact with the nerve bundle in the neuromembrane, and the electrode site of the wrapped part is in contact with the epineurium; the current pulse is transmitted to the epineurium through the electrode sites of the implanted part and the wrapped part respectively. Perform nerve electrical stimulation within the nerve or collect nerve signals to external equipment for nerve recording; or jointly optimize the configuration of the electrode sites of the implanted part and the wrapped part to build a fine current loop to achieve more precise spatially oriented stimulation and Record.
优选地，所述穿植部分可以从所述立体柔性电极上拉起，能垂直于神经或与神经成其他角度植入神经内。Preferably, the implantation part can be pulled up from the three-dimensional flexible electrode and can be implanted into the nerve perpendicularly or at other angles to the nerve.
优选地，所述穿植部分可以根据使用需求与包裹部分的两边垂直、平行或成其他角度。具体根据立体柔性电极与神经的位置确定，方便植入。Preferably, the perforating part can be perpendicular, parallel or at other angles to both sides of the wrapping part according to usage requirements. The details are determined based on the position of the three-dimensional flexible electrode and the nerve to facilitate implantation.
优选地，所述穿植部分的尖状部位设有牵引孔，用于将穿植部分从包裹部分的缺口中拉起以及与神经固定。Preferably, the pointed part of the puncture part is provided with a traction hole for pulling up the puncture part from the gap of the wrapping part and fixing it with the nerve.
优选地，所述包裹部分的两侧设有固定孔，用于在包裹部分包裹神经外膜时，对包裹部分进行固定。Preferably, the wrapping part is provided with fixing holes on both sides for fixing the wrapping part when the wrapping part wraps the epineurium.
可选择地，所述的穿植部分包含至少一个条形结构；当条形结构为两个或以上时，使用时把两个或以上的条形结构对称折叠。Optionally, the perforation part includes at least one strip structure; when there are two or more strip structures, the two or more strip structures are folded symmetrically during use.
可选择地，所述基底层和覆盖层的材料为聚酰亚胺、聚二甲基硅氧烷、聚对二甲苯、环氧树脂、聚酰胺酰亚胺、SU-8光刻胶、硅胶、硅橡胶中的任一种或其组合。Optionally, the materials of the base layer and the covering layer are polyimide, polydimethylsiloxane, parylene, epoxy resin, polyamideimide, SU-8 photoresist, and silica gel. , any one of silicone rubber or a combination thereof.
可选择地，所述的电极位点由导电材料构成，导电材料包含金、铂、铱、钨、铂铱合金、钛合金、石墨、碳纳米管、PEDOT中的至少一种。Optionally, the electrode sites are made of conductive materials, and the conductive materials include at least one of gold, platinum, iridium, tungsten, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, and PEDOT.
一种外周神经定向空间刺激记录的立体柔性电极制备方法，包括：A three-dimensional flexible electrode preparation method for peripheral nerve directional spatial stimulation recording, including:
在硅片上涂覆基底层并刻蚀和沉积得到导线层；Coating a base layer on the silicon wafer, etching and depositing it to obtain a conductor layer;
涂覆覆盖层后刻蚀去除多余部分，包括把穿植部分和包裹部分的分界线刻穿，保留所需结构；After applying the covering layer, etch and remove the excess part, including carving through the dividing line between the implanted part and the wrapped part, to retain the required structure;
最后从硅片分离电极，使用时把穿植部分和包裹部分轻轻分离。Finally, separate the electrode from the silicon wafer. When using, gently separate the implanted part and the wrapped part.
与现有技术相比，本发明具有以下有益效果：Compared with the prior art, the present invention has the following beneficial effects:
1、本发明中，电极神经包裹部分的包裹保护提供了稳定的固定手段，减少了电极移动或脱落的风险。1. In the present invention, the wrapping and protection of the nerve wrapping part of the electrode provides a stable means of fixation and reduces the risk of the electrode moving or falling off.
2、本发明中，电极结合了外周神经膜内和膜外刺激和记录的优点，可适应不同的使用场景需要。2. In the present invention, the electrode combines the advantages of stimulation and recording within and outside the peripheral nerve membrane, and can adapt to the needs of different usage scenarios.
3、本发明中，穿植部分和包裹部分的电极位点可进行联合优化配置，实现更精准的空间定向刺激和记录。3. In the present invention, the electrode sites of the implanted part and the wrapped part can be jointly optimized and configured to achieve more precise spatially oriented stimulation and recording.
4、本发明中，使用生物相容性材料制作电极，降低了植入后的不良反应，提高电极的长期稳定性。4. In the present invention, biocompatible materials are used to make electrodes, which reduces adverse reactions after implantation and improves the long-term stability of the electrodes.
5、本发明中，电极尺寸、形状和接口定制方便，可以根据不同的需求低成本地进行设计和制造。5. In the present invention, the electrode size, shape and interface can be easily customized, and can be designed and manufactured at low cost according to different needs.
附图说明Description of drawings
图1为本发明实施例一种外周神经定向空间刺激记录的立体柔性电极结构示意图；Figure 1 is a schematic structural diagram of a three-dimensional flexible electrode for directional spatial stimulation recording of peripheral nerves according to an embodiment of the present invention;
图2为沿图1所示虚线a的剖视图；Figure 2 is a cross-sectional view along the dotted line a shown in Figure 1;
图3为沿图1所示虚线b的剖视图；Figure 3 is a cross-sectional view along the dotted line b shown in Figure 1;
图4为本发明实施例一种外周神经定向空间刺激记录的立体柔性电极制备方法流程图；Figure 4 is a flow chart of a three-dimensional flexible electrode preparation method for peripheral nerve directional spatial stimulation recording according to an embodiment of the present invention;
图5为本发明实施例中将图1所示立体柔性电极卷曲得到的立体结构示意图；Figure 5 is a schematic diagram of the three-dimensional structure obtained by curling the three-dimensional flexible electrode shown in Figure 1 in an embodiment of the present invention;
图6为本发明实施例中利用包裹部分电极位点进行配置构建刺激电流回路的电场分布示意图；Figure 6 is a schematic diagram of the electric field distribution of configuring and constructing a stimulation current loop by wrapping some electrode sites in an embodiment of the present invention;
图7为本发明实施例中利用穿植部分电极位点进行配置构建刺激电流回路的电场分布示意图；Figure 7 is a schematic diagram of the electric field distribution using implanted partial electrode sites to configure and construct a stimulation current circuit in an embodiment of the present invention;
图8为本发明实施例中利用穿植部分和包裹部分电极位点进行配置构建刺激电流回路的电场分布示意图；Figure 8 is a schematic diagram of the electric field distribution using the implanted part and the wrapped part of the electrode sites to construct a stimulation current circuit in an embodiment of the present invention;
图9本发明实施例中将图1所示立体柔性电极植入外周神经效果示意图；Figure 9 is a schematic diagram of the effect of implanting the three-dimensional flexible electrode shown in Figure 1 into peripheral nerves in an embodiment of the present invention;
图10为本发明实施例另一种外周神经定向空间刺激记录的立体柔性电极结构示意图。Figure 10 is a schematic diagram of another three-dimensional flexible electrode structure for directional spatial stimulation recording of peripheral nerves according to an embodiment of the present invention.
具体实施方式Detailed ways
下面结合附图和实施例对本发明做进一步详细描述，需要指出的是，以下所述实施例旨在便于对本发明的理解，而对其不起任何限定作用。The present invention will be described in further detail below with reference to the accompanying drawings and examples. It should be noted that the following examples are intended to facilitate the understanding of the present invention and do not limit it in any way.
如图1所示，一种外周神经定向空间刺激记录的立体柔性电极，包括穿植部分1和包裹部分2，本实施例中，穿植部分1包含单个条形结构。穿植部分1有牵引孔11和电极位点12，膜外部位有固定孔21和电极位点22，穿植部分1能够穿透神经膜内植入神经束中，包裹部分2能够包裹在神经外膜上。植入后电极位点12和膜内的神经束接触，电极位点22和神经外膜接触，从而能够实现外周神经膜内膜外同时植入以进行神经记录或神经刺激，并且既能保证记录或刺激到深层神经束又能稳定地使电极固定在神经上。各部分电极位点12和电极位点22通过导线13和导线23可与电极接口0相连，从而进一步与外部设备连接。具体而言，穿植部分1可以垂直于神经植入，平行于神经植入，也可以与神经成其他角度植入，包裹部分2可以从两边弯曲，从对角弯曲，也可以从其他位置弯曲或螺旋起来包裹在神经外膜上。As shown in Figure 1, a three-dimensional flexible electrode for peripheral nerve directional spatial stimulation recording includes a perforation part 1 and a wrapping part 2. In this embodiment, the perforation part 1 includes a single strip structure. The perforation part 1 has a traction hole 11 and an electrode site 12, and the extramembranous part has a fixation hole 21 and an electrode site 22. The perforation part 1 can penetrate the neural membrane and be implanted into the nerve bundle, and the wrapping part 2 can wrap around the nerve. on the outer membrane. After implantation, the electrode site 12 is in contact with the nerve bundle in the membrane, and the electrode site 22 is in contact with the epineurium, so that the peripheral nerve membrane can be implanted simultaneously inside and outside the membrane for nerve recording or nerve stimulation, and recording can be guaranteed. Or it can stimulate the deep nerve bundle and stably fix the electrode on the nerve. Each part of the electrode site 12 and the electrode site 22 can be connected to the electrode interface 0 through the wire 13 and the wire 23, so as to be further connected to external equipment. Specifically, the implantation part 1 can be implanted perpendicularly to the nerve, parallel to the nerve, or at other angles to the nerve. The wrapping part 2 can be bent from both sides, diagonally, or from other positions. or spirally wrapped around the epineurium.
图2和图3所示，穿植部分1包含基底层14、覆盖层15以及位于基底层14和覆盖层15之间的导线层13。包裹部2分包含基底层24、覆盖层25以及位于基底层24和覆盖层25之间的导线层23。电极位点12和电极位点22暴露在外界，表面不设绝缘层，穿植部分1和包裹部分2交界线整个电极层被刻蚀穿，电极两部分分离。As shown in FIGS. 2 and 3 , the implanted part 1 includes a base layer 14 , a covering layer 15 , and a conductor layer 13 located between the base layer 14 and the covering layer 15 . The wrapping part 2 includes a base layer 24 , a covering layer 25 , and a conductor layer 23 located between the base layer 24 and the covering layer 25 . The electrode site 12 and the electrode site 22 are exposed to the outside world, and there is no insulating layer on the surface. The entire electrode layer at the boundary between the implanted part 1 and the wrapped part 2 is etched through, and the two parts of the electrode are separated.
在其中一个实施例中，基底层和覆盖层的材质为聚酰亚胺(Ploymide,PI)。聚酰亚胺具有良好的柔韧性和延展性以及生物相容性，并能够满足通过微纳加工技术精确制备微型电极和微型通道的需要。采用聚酰亚胺作为基底和绝缘层使得电极具有良好的形变能力和可拉伸性，能够保证电极和神经良好的贴合和电极不易断裂。且电极可以实现个性化的定制，电极的所有尺寸和电极位点数量和排布都可以根据使用需求进行设计，不需要高昂的制作成本。且所述方法可以达到微米级的加工精度，能够保证电极的精细结构，从而保证神经记录和神经刺激的最大性能。电极接口也可方便地定制，与外部设备可以通过印刷电路板(Printed Circuit Board，PCB)、柔性电路板(Flexible Printed Circuit，FPC)等与Omnetics或Samtec等通用接口连接，也可以根据需求进行设计。In one embodiment, the base layer and the cover layer are made of polyimide (PI). Polyimide has good flexibility, ductility and biocompatibility, and can meet the needs of precise preparation of micro-electrodes and micro-channels through micro-nano processing technology. The use of polyimide as the base and insulating layer enables the electrode to have good deformation ability and stretchability, which can ensure good fit between the electrode and the nerve and the electrode is not easy to break. Moreover, the electrodes can be personalized and customized. All sizes of the electrodes and the number and arrangement of electrode sites can be designed according to the needs of use, without high production costs. And the method can achieve micron-level processing accuracy and ensure the fine structure of the electrode, thereby ensuring the maximum performance of nerve recording and nerve stimulation. The electrode interface can also be easily customized, and can be connected to external devices through Printed Circuit Board (PCB), Flexible Printed Circuit (FPC), etc. with common interfaces such as Omnetics or Samtec, or it can be designed according to needs. .
在其中一个实施例中，电极位点和导线层的材质为铬金双金属。铬金金属具有良好的导电性能，可以保证电极用于神经刺激时具有良好的电荷注入能力,此外还可以在电极位点表面电镀一层铂金属或其他金属，进一步增强电极位点的放电能力或采集信号的能力。In one embodiment, the material of the electrode site and the conductor layer is chromium-gold bimetal. Chromium gold metal has good electrical conductivity, which can ensure that the electrode has good charge injection ability when used for nerve stimulation. In addition, a layer of platinum metal or other metals can be electroplated on the surface of the electrode site to further enhance the discharge capacity of the electrode site or The ability to collect signals.
如图4所示，一种外周神经定向空间刺激记录的立体柔性电极制备方法，包括以下步骤：As shown in Figure 4, a three-dimensional flexible electrode preparation method for peripheral nerve directional spatial stimulation recording includes the following steps:
S01，准备基底：清洗硅片，确保其表面干净并无杂质。S01, prepare the substrate: Clean the silicon wafer to ensure that its surface is clean and free of impurities.
S02，底层金属沉积：使用电子束蒸发过程，在硅片表面均匀镀膜一层铝，作为牺牲层。S02, underlying metal deposition: Using an electron beam evaporation process, a layer of aluminum is evenly coated on the surface of the silicon wafer as a sacrificial layer.
S03，涂覆第一层聚酰亚胺：以适当的转速将聚酰亚胺涂覆在硅片表面，形成薄膜。S03, apply the first layer of polyimide: Coat polyimide on the surface of the silicon wafer at an appropriate rotation speed to form a thin film.
S04，光刻导线层：通过光刻技术，在聚酰亚胺上形成所需的导线图案。S04, photolithography wire layer: Use photolithography technology to form the required wire pattern on the polyimide.
S05，金属化处理：使用电子束蒸发，在硅片上镀上铬金金属，以制备导线层。S05, metallization treatment: Use electron beam evaporation to plate chromium gold metal on the silicon wafer to prepare the wire layer.
S06，图案形成：用丙酮去除不需要的部分，形成所需图案。S06, Pattern formation: Use acetone to remove unnecessary parts to form the desired pattern.
S07，涂覆第二层聚酰亚胺：再次涂覆聚酰亚胺，以封住金属导线并提供保护。S07, Apply a second layer of polyimide: Apply polyimide again to seal and protect the metal wires.
S08，光刻外形层：通过光刻技术，形成所需的电极外形。S08, photolithography profile layer: Use photolithography technology to form the required electrode profile.
S09，金属化处理：使用电子束蒸发过程，在电极上镀上一层铝金属层，作为掩膜层。S09, metallization treatment: Using an electron beam evaporation process, a layer of aluminum metal is plated on the electrode as a mask layer.
S10，图案形成：用丙酮泡去牺牲层以去除不需要的部分。S10, pattern formation: Use acetone bubbles to remove the sacrificial layer to remove unnecessary parts.
S11，外形刻蚀：使用等离子刻蚀系统进行刻蚀，保留电极所需结构。S11, profile etching: Use a plasma etching system to etch and retain the required structure of the electrode.
S12，电解剥离：通过电解过程，将硅片上的底层铝剥离，从而分离电极。S12, electrolytic stripping: Through the electrolysis process, the underlying aluminum on the silicon wafer is peeled off to separate the electrodes.
图5为本发明实施例中将图1所示立体柔性电极卷曲得到的立体结构示意图，穿植部分1包含一个条形结构，使用时先将此结构提起分离，可垂直于神经或与神经成其他角度以进一步完成电极穿植部分的植入。包裹部分2卷曲形成神经套管，可包裹在神经上以进一步完成电极包裹部分的植入。具体而言，牵引线3可以通过牵引孔11把穿植部分1牵引到神经内目标位置，从而引导电极完成植入过程，最后连着牵引孔1的牵引线还可以绑在神经上进一步固定。包裹部分2具有固定孔21，将电极包裹部分2包裹在神经上后，用缝线4穿过电极两侧的固定孔21并绑住，还可以将固定孔21和神经外膜缝在一起，可以使电极更稳定地固定在神经上。Figure 5 is a schematic diagram of the three-dimensional structure obtained by curling the three-dimensional flexible electrode shown in Figure 1 in an embodiment of the present invention. The implantation part 1 includes a strip structure. During use, this structure is lifted up and separated first. It can be perpendicular to the nerve or formed with the nerve. Other angles to further complete the implantation of the electrode implantation part. The wrapping part 2 is curled to form a nerve sleeve, which can be wrapped around the nerve to further complete the implantation of the electrode wrapping part. Specifically, the traction wire 3 can pull the implantation part 1 to the target position in the nerve through the traction hole 11, thereby guiding the electrode to complete the implantation process. Finally, the traction wire connected to the traction hole 1 can be tied to the nerve for further fixation. The wrapping part 2 has a fixing hole 21. After wrapping the electrode wrapping part 2 on the nerve, use suture 4 to pass through the fixing holes 21 on both sides of the electrode and tie it. You can also sew the fixing hole 21 and the epineurium together. The electrode can be fixed on the nerve more stably.
图6为本发明实施例中利用包裹部分电极位点进行配置构建刺激电流回路的电场分布示意图；图7为本发明实施例中利用穿植部分电极位点进行配置构建刺激电流回路的电场分布示意图；图8为本发明实施例中利用穿植部分和包裹部分电极位点进行配置构建刺激电流回路的电场分布示意图。电极用于外周神经刺激时，利用不同电极位点构建的刺激电流回路电场分布不同，利用包裹部分2的电极位点刺激主要容易激活神经外膜附近的边缘神经束，利用穿植部分1的电极位点主要容易激活神经内部的深层神经束，利用穿植部分1和包裹部分2电极位点联合还可以更有选择地激活某一区域的部分神经束。实际使用时可以对不同电极位点进行配置以确定激活目标点位的最佳配置方案，从而实现精准激活目标神经束而对其余神经束激活最小化，提高刺激的定向空间选择性。Figure 6 is a schematic diagram of the electric field distribution of a stimulation current circuit constructed by wrapping some electrode sites in an embodiment of the present invention; Figure 7 is a schematic diagram of the electric field distribution of a stimulation current circuit constructed by arranging and implanting some electrode sites in an embodiment of the present invention. ; Figure 8 is a schematic diagram of the electric field distribution of the stimulation current circuit constructed by configuring the implanted part and the wrapped part of the electrode sites in the embodiment of the present invention. When electrodes are used for peripheral nerve stimulation, the electric field distribution of the stimulation current loop constructed using different electrode sites is different. Using the electrode site of the wrapped part 2 to stimulate is mainly easy to activate the marginal nerve bundle near the epineurium, and using the electrode of the implanted part 1 The site is mainly easy to activate the deep nerve bundles inside the nerve. The combination of the implanted part 1 and the wrapped part 2 electrode sites can also more selectively activate part of the nerve bundles in a certain area. In actual use, different electrode positions can be configured to determine the optimal configuration scheme for activating the target point, thereby achieving precise activation of the target nerve bundle while minimizing the activation of other nerve bundles, and improving the directional spatial selectivity of stimulation.
图9本发明实施例中将图1所示立体柔性电极植入外周神经效果示意图，采用本发明提供的外周神经定向空间刺激记录的立体柔性电极植入外周神经的方法包含如下步骤：Figure 9 is a schematic diagram of the effect of implanting the three-dimensional flexible electrode shown in Figure 1 into the peripheral nerve in an embodiment of the present invention. The method of implanting the three-dimensional flexible electrode into the peripheral nerve using the peripheral nerve directional spatial stimulation recording provided by the present invention includes the following steps:
1、通过微创手术暴露需要植入的外周神经5；1. Expose the peripheral nerves to be implanted through minimally invasive surgery5;
2、将牵引针和牵引线3穿过电极穿植部分的牵引孔，将电极穿植部分1慢慢分离；2. Pass the traction needle and traction wire 3 through the traction hole of the electrode implantation part, and slowly separate the electrode implantation part 1;
3、利用牵引针和牵引线穿过神经外膜把电极穿植部分植入到神经束6中；3. Use the traction needle and traction wire to pass through the epineurium and implant the electrode implantation part into the nerve bundle 6;
4、电极穿植部分1从神经外膜穿出后把缝线4绑缚在神经上固定；4. After the electrode implantation part 1 passes through the epineurium, the suture 4 is tied to the nerve and fixed;
5、将电极包裹部分2弯曲起来包裹在外周神经的神经外膜上；5. Bend the electrode wrapping part 2 and wrap it on the epineurium of the peripheral nerve;
6、利用缝线4穿过电极两端的固定孔并绑紧；6. Use suture 4 to pass through the fixing holes at both ends of the electrode and tie it tightly;
7、把电极与外部设备连接的接头固定在指定位置；7. Fix the connector connecting the electrode to the external device at the designated position;
8、缝合肌肉和皮肤。8. Suture the muscles and skin.
本发明一个实施例为将所述立体柔性电极植入瘫痪被试的上肢的神经进行外周神经刺激以重建手部运动功能。电极上分布有16个电极位点，其中8个位点位于穿植部分，另外8个位点位于包裹部分，电极位点直径为80微米，两个电极位点之间间距为300微米。电极接口端通过热压接的方式与柔性电路板一端连接，2×10Pin的1.27毫米间距排母座与柔性电路板另一端连接，最终电极可通过排母座和外部设备相连接。通过上述步骤将电极植入被试肌皮神经、尺神经、正中神经和桡神经后，将PlexonStim刺激器输出端和电极连接，通过向不同电极位点施加双相正负电荷平衡脉冲刺激，脉冲幅值为100-500uA、脉宽为50-200us、频率为50-100Hz，可以募集神经激活肌肉从而完成屈肘、伸肘、屈腕、伸腕、手闭合和手打开等动作。其中，由于控制手指的是深层肌肉，对应的支配神经束也位于神经中心位置。因此当包裹部分的电极位点刺激无法激活深层手指肌肉时，可以利用穿植部分的电极位点对深层神经进行刺激。One embodiment of the present invention is to implant the three-dimensional flexible electrode into the nerve of the upper limb of a paralyzed subject to perform peripheral nerve stimulation to reconstruct hand movement function. There are 16 electrode sites distributed on the electrode, 8 sites are located in the implantation part, and the other 8 sites are located in the wrapping part. The diameter of the electrode site is 80 microns, and the distance between the two electrode sites is 300 microns. The electrode interface end is connected to one end of the flexible circuit board through thermocompression bonding, and the 2×10Pin 1.27 mm spacing female header is connected to the other end of the flexible circuit board. Finally, the electrode can be connected to external equipment through the female header. After the electrodes are implanted into the subject's musculocutaneous nerve, ulnar nerve, median nerve and radial nerve through the above steps, connect the output end of the PlexonStim stimulator to the electrodes, and stimulate the pulse by applying biphasic positive and negative charge balance pulses to different electrode sites. The amplitude is 100-500uA, the pulse width is 50-200us, and the frequency is 50-100Hz. It can recruit nerves to activate muscles to complete actions such as elbow flexion, elbow extension, wrist flexion, wrist extension, hand closing and hand opening. Among them, since the fingers are controlled by deep muscles, the corresponding innervating nerve bundles are also located in the nerve center. Therefore, when the stimulation of the electrode sites on the wrapped part cannot activate the deep finger muscles, the electrode sites on the implanted part can be used to stimulate the deep nerves.
进一步地，当植入的神经中控制不同肌肉的神经束十分密集时，穿植部分刺激位点也可能激活其周围一片神经束，从而激活其他非目标肌肉降低刺激的选择性，此时可以通过膜内膜外电极位点的配置构建不同的刺激电流回路，形成不同的电场分布，从而能够找到形成精准刺激目标神经束的最优的电极位点配置方式，使目标肌肉能够按预期激活的同时降低附近其他非目标神经束的激活，进一步提高刺激的选择性。得到每个肌肉和关节运动对应的最优电极位点配置后可以通过控制刺激程序的软件编写序列刺激把不同动作组合以完成功能性的伸手抓握运动，从而重建手部的重要部分运动功能。此外，电极的外部接口可通过导线、无线通信等方式定制，以满足不同治疗需求和技术要求。Furthermore, when the nerve bundles controlling different muscles in the implanted nerve are very dense, the implanted part of the stimulation site may also activate a nerve bundle around it, thereby activating other non-target muscles and reducing the selectivity of the stimulation. In this case, the stimulation site can be The configuration of electrode sites inside and outside the membrane constructs different stimulation current loops and forms different electric field distributions, so that the optimal electrode site configuration can be found to accurately stimulate the target nerve bundle, so that the target muscles can be activated as expected. Reduces activation of other nearby non-target nerve bundles, further improving stimulation selectivity. After obtaining the optimal electrode position configuration corresponding to each muscle and joint movement, the software that controls the stimulation program can write sequence stimulation to combine different actions to complete functional reaching and grasping movements, thereby reconstructing important parts of the hand's movement functions. In addition, the external interface of the electrode can be customized through wires, wireless communication, etc. to meet different treatment needs and technical requirements.
图10为本发明实施例另一种外周神经定向空间刺激记录的立体柔性电极结构示意图。如图所示，本发明提供的外周神经定向空间刺激记录的立体柔性电极穿植部分还可以包括两个或多个条形物，当穿植部分1包括两个条形物时，优选地可以把两个条形物设计为“人字形”的平面结构布局，使用时可先把“人字形”条形物提起分离，再将条形物沿着其中线对折，使其两边电极位点背靠背贴着，从而实现穿植部分植入之后两面都有电极位点分布，可以同时进行神经刺激或者神经记录，可实现与横向多通道束内刺激电极(TIME)一样的膜内刺激效果。Figure 10 is a schematic diagram of another three-dimensional flexible electrode structure for directional spatial stimulation recording of peripheral nerves according to an embodiment of the present invention. As shown in the figure, the three-dimensional flexible electrode implantation part for peripheral nerve directional spatial stimulation recording provided by the present invention can also include two or more strips. When the implantation part 1 includes two strips, it can preferably be Design the two strips into a "herringbone" planar structure layout. When using, you can first lift up and separate the "herringbone" strips, and then fold the strips in half along the center line so that the electrode sites on both sides are back to back. After the implantation, the implanted part has electrode sites distributed on both sides, which can perform nerve stimulation or nerve recording at the same time, and can achieve the same intramembrane stimulation effect as the transverse multi-channel intrafascicular stimulation electrode (TIME).
以上所述的实施例对本发明的技术方案和有益效果进行了详细说明，应理解的是以上所述仅为本发明的具体实施例，并不用于限制本发明，凡在本发明的原则范围内所做的任何修改、补充和等同替换，均应包含在本发明的保护范围之内。The above-described embodiments describe in detail the technical solutions and beneficial effects of the present invention. It should be understood that the above-mentioned are only specific embodiments of the present invention and are not intended to limit the present invention. Any modifications, additions and equivalent substitutions should be included in the protection scope of the present invention.
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| CN202311493942.3ACN117618768B (en) | 2023-11-10 | 2023-11-10 | A three-dimensional flexible electrode for peripheral nerve directional spatial stimulation recording and its preparation method |
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| CN202311493942.3ACN117618768B (en) | 2023-11-10 | 2023-11-10 | A three-dimensional flexible electrode for peripheral nerve directional spatial stimulation recording and its preparation method |
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| CN202311493942.3AActiveCN117618768B (en) | 2023-11-10 | 2023-11-10 | A three-dimensional flexible electrode for peripheral nerve directional spatial stimulation recording and its preparation method |
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