CN117618768A - Three-dimensional flexible electrode for peripheral nerve directional space stimulation recording and preparation method thereof - Google Patents
Three-dimensional flexible electrode for peripheral nerve directional space stimulation recording and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a three-dimensional flexible electrode for peripheral nerve directional space stimulation recording and a preparation method thereof, wherein the three-dimensional flexible electrode comprises a penetration part and a wrapping part, and the wrapping part is provided with a notch matched with the shape of the penetration part; the penetrating part is embedded in the notch, one end of the penetrating part is a strip-shaped structure fixedly connected with the wrapping part, and the other end of the strip-shaped structure is pointed; the implantation part is used for penetrating the nerve membrane and implanting the nerve bundle into the nerve membrane, and the wrapping part is used for curling and wrapping the nerve membrane; the penetrating part and the wrapping part comprise a basal layer, a covering layer and a wire layer positioned between the basal layer and the covering layer; the covering layers of the penetrating part and the wrapping part are provided with a plurality of electrode sites which are respectively connected to the electrode interfaces through wires on the corresponding wire layers; the electrode interface is connected with external equipment. The invention can improve the space orientation selectivity and the accuracy of stimulation and recording, and can also ensure the long-time stable fixation of the electrode on the nerve.
Description
Technical Field
The invention belongs to the field of medical equipment, and particularly relates to a three-dimensional flexible electrode for peripheral nerve directional space stimulation recording and a preparation method thereof.
Background
The electrodes commonly used in the peripheral nerve research at present comprise an extraneural electrode wrapped outside the nerve membrane and an intra-neural electrode implanted in the nerve membrane. The extramembranous electrode mainly comprises a Cuff electrode, a FINE electrode and the like, and can be wrapped on peripheral nerves when in use, and nerve stimulation or recording is carried out from outside the nerve membrane by utilizing electrode sites.
The chinese patent publication CN102764479a discloses a flexible nerve bundle electrode, which comprises a flexible substrate, an electrode unit, an electrode lead, a lead welding point and an insulating layer, wherein the electrode lead is electrically connected with the electrode unit and the lead welding point, the electrode unit, the electrode lead and the lead welding point together form an electrode assembly, the electrode assembly is arranged on the flexible substrate, the insulating layer is arranged on the flexible substrate and covers the electrode lead, and the electrode unit is used for electrically connecting the nerve bundle.
The membrane electrode mainly comprises USEA, TIME, LIFE electrode and the like, and is implanted into the nerve bundle by penetrating the adventitia when in use, and nerve stimulation or recording is carried out on the nearby nerve bundle by utilizing the electrode site.
A linear flexible electrode for peripheral nerve is disclosed in chinese patent publication No. CN115054824a, and includes an implantation portion and a fixation portion, at least a part of which can be implanted into a peripheral nerve bundle.
However, the conventional intra-membrane and extra-membrane stimulating electrodes have various limitations in practical application, such as difficulty in fixation, easiness in displacement and even falling off during implantation of the intra-membrane electrode, and the extra-membrane electrode has the defects of larger current threshold, difficulty in activating deep muscles, limited selectivity and the like during stimulation, and has the problems of lower signal-to-noise ratio, insufficient spatial resolution and the like during recording, and the development of peripheral nerve stimulation research is severely restricted by the limiting factors.
Therefore, there is a need for a peripheral nerve electrode that can accurately achieve both intra-membrane stimulation and recording and ensure stable fixation for a long period of time.
Disclosure of Invention
The invention provides a stereoscopic flexible electrode for peripheral nerve directional space stimulation recording and a preparation method thereof, which can improve the spatial directional selectivity and the accuracy of stimulation and recording and can also ensure the long-time stable fixation of the electrode on nerves.
The stereoscopic flexible electrode comprises a flexible implantation part and a wrapping part, wherein the wrapping part is provided with a notch matched with the outline of the implantation part; the embedded part is embedded in the notch, the embedded part is a strip-shaped structure with one end connected and fixed with the wrapping part, and the other end of the strip-shaped structure is pointed;
the implantation part is used for penetrating the nerve membrane and being implanted into the nerve bundle, and the wrapping part is used for being wrapped and fixed on the nerve adventitia in a curling way;
the penetrating part and the wrapping part comprise a basal layer, a covering layer and a wire layer positioned between the basal layer and the covering layer; the covering layers of the penetrating part and the wrapping part are respectively provided with a plurality of electrode sites, and the electrode sites are respectively connected to the electrode interfaces through wires on the corresponding wire layers; the electrode interface is connected with external equipment.
In the invention, electrode sites are distributed on the implantation part and can be used for stimulating or recording in the neural membrane; the wrapping part is distributed with electrode sites, which can be used for external nerve membrane stimulation or recording; the electrode sites of each part can be used in a combined configuration, and various fine current loops are constructed to adapt to different nerve stimulation or record use scenes. The shape, size and number of electrode sites can be conveniently customized individually to the needs of the application.
The electrode site of the implanted part is contacted with the nerve bundle in the nerve membrane after the electrode is implanted, and the electrode site of the wrapped part is contacted with the nerve adventitia; the current pulse is transmitted into the nerve through the electrode sites of the implantation part and the wrapping part to perform nerve electrical stimulation or the nerve signal is collected to external equipment to perform nerve recording; or the electrode sites of the implantation part and the wrapping part are subjected to joint optimization configuration to construct a fine current loop, so that more accurate space directional stimulation and recording are realized.
Preferably, the implanted portion may be pulled up from the stereotactic flexible electrode, implanted into the nerve perpendicular to the nerve or at other angles to the nerve.
Preferably, the implanted portion may be perpendicular, parallel or at other angles to both sides of the wrapping portion depending on the application. And the method is particularly determined according to the positions of the three-dimensional flexible electrode and the nerve, and is convenient to implant.
Preferably, the pointed part of the implanted part is provided with a traction hole for pulling the implanted part up from the notch of the wrapping part and fixing the implanted part with the nerve.
Preferably, fixing holes are provided at both sides of the wrapping portion for fixing the wrapping portion when the wrapping portion wraps the outer membrane of the nerve.
Optionally, the implant portion comprises at least one strip-like structure; when the strip-shaped structures are two or more, the two or more strip-shaped structures are symmetrically folded when in use.
Optionally, the material of the base layer and the cover layer is any one of polyimide, polydimethylsiloxane, parylene, epoxy resin, polyamideimide, SU-8 photoresist, silica gel, silicone rubber or a combination thereof.
Optionally, the electrode site is made of a conductive material, and the conductive material includes at least one of gold, platinum, iridium, tungsten, platinum iridium alloy, titanium alloy, graphite, carbon nanotube, and PEDOT.
A preparation method of a stereoscopic flexible electrode for peripheral nerve directional space stimulation recording comprises the following steps:
coating a substrate layer on a silicon wafer, and etching and depositing to obtain a wire layer;
etching to remove redundant parts after coating the covering layer, including cutting through the boundary between the implanted part and the wrapping part, and reserving a required structure;
finally, the electrode is separated from the silicon wafer, and the implanted part and the wrapping part are gently separated when the electrode is used.
Compared with the prior art, the invention has the following beneficial effects:
1. in the invention, the wrapping protection of the electrode nerve wrapping part provides a stable fixing means, and reduces the risk of electrode movement or falling.
2. In the invention, the electrode combines the advantages of the stimulation and recording of the inner and outer peripheral nerve films, and can adapt to the requirements of different use situations.
3. According to the invention, the electrode sites of the implantation part and the wrapping part can be combined and optimally configured, so that more accurate space directional stimulation and recording are realized.
4. In the invention, the electrode is made of the biocompatible material, so that adverse reaction after implantation is reduced, and long-term stability of the electrode is improved.
5. In the invention, the electrode size, shape and interface are convenient to customize, and the electrode can be designed and manufactured with low cost according to different requirements.
Drawings
FIG. 1 is a schematic view of a three-dimensional flexible electrode structure for peripheral nerve directional space stimulation recording according to an embodiment of the present invention;
FIG. 2 is a cross-sectional view taken along the dashed line a shown in FIG. 1;
FIG. 3 is a cross-sectional view taken along the dashed line b shown in FIG. 1;
FIG. 4 is a flowchart of a method for preparing a stereoscopic flexible electrode for peripheral nerve directional space stimulation recording according to an embodiment of the invention;
FIG. 5 is a schematic diagram of a three-dimensional structure obtained by crimping the three-dimensional flexible electrode shown in FIG. 1 according to an embodiment of the present invention;
FIG. 6 is a schematic diagram of electric field distribution of a stimulus current loop configured with wrap-around electrode sites in an embodiment of the invention;
FIG. 7 is a schematic diagram of electric field distribution of a stimulation current loop configured by using electrode sites of a implanted portion in an embodiment of the present invention;
FIG. 8 is a schematic diagram of electric field distribution of a stimulation current loop configured with electrode sites of a implanted portion and a wrapped portion in an embodiment of the present invention;
FIG. 9 is a schematic diagram showing the effect of implanting the stereoscopic flexible electrode shown in FIG. 1 into peripheral nerves according to an embodiment of the invention;
fig. 10 is a schematic view of a three-dimensional flexible electrode structure for peripheral nerve directional space stimulation recording according to another embodiment of the present invention.
Detailed Description
The invention will be described in further detail with reference to the drawings and examples, it being noted that the examples described below are intended to facilitate the understanding of the invention and are not intended to limit the invention in any way.
As shown in fig. 1, a stereoscopic flexible electrode for peripheral nerve directional space stimulation recording comprises a penetration part 1 and a wrapping part 2, wherein the penetration part 1 comprises a single strip-shaped structure. The implantation part 1 is provided with a traction hole 11 and an electrode site 12, the outer part of the membrane is provided with a fixing hole 21 and an electrode site 22, the implantation part 1 can penetrate through the nerve membrane to be implanted into the nerve bundle, and the wrapping part 2 can wrap the nerve adventitia. The post-implantation electrode site 12 is in contact with the nerve bundles within the membrane and the electrode site 22 is in contact with the adventitia, thereby enabling simultaneous implantation outside the peripheral intima for nerve recording or nerve stimulation, and ensuring both recording or stimulation to the deep nerve bundles and stable fixation of the electrode to the nerve. The respective parts of electrode site 12 and electrode site 22 are connectable to electrode interface 0 via wires 13 and 23 for further connection to external devices. Specifically, the implanted portion 1 may be implanted perpendicular to the nerve, parallel to the nerve, or implanted at other angles to the nerve, and the wrapping portion 2 may be bent from both sides, diagonally, or from another location or wrapped around the adventitia by being twisted.
As shown in fig. 2 and 3, the implanted portion 1 includes a base layer 14, a cover layer 15, and a wire layer 13 between the base layer 14 and the cover layer 15. The wrapping portion 2 includes a base layer 24, a cover layer 25, and a wire layer 23 between the base layer 24 and the cover layer 25. The electrode sites 12 and 22 are exposed to the outside, no insulating layer is arranged on the surface, the whole electrode layer of the boundary line between the implanted part 1 and the wrapping part 2 is etched through, and the two parts of the electrode are separated.
In one embodiment, the base layer and the cover layer are made of Polyimide (PI). Polyimide has good flexibility and ductility and biocompatibility, and can meet the requirement of precisely preparing microelectrodes and micro-channels by micro-nano processing technology. Polyimide is used as a substrate and an insulating layer, so that the electrode has good deformability and stretchability, and good adhesion between the electrode and nerves and difficult breakage of the electrode can be ensured. And the electrode can be customized individually, all sizes of the electrode and the number and arrangement of electrode sites can be designed according to the use requirement, and high manufacturing cost is not required. The method can reach micron-scale machining precision, and can ensure the fine structure of the electrode, thereby ensuring the maximum performance of nerve recording and nerve stimulation. The electrode interface can be conveniently customized, and can be connected with external equipment through a printed circuit board (Printed Circuit Board, PCB), a flexible circuit board (Flexible Printed Circuit, FPC) and other general interfaces such as Omnetics or Samtec, and can also be designed according to requirements.
In one embodiment, the electrode sites and the conductive line layer are made of chrome-gold bimetallic. The chromium-gold metal has good conductivity, can ensure that the electrode has good charge injection capability when being used for nerve stimulation, and can further plate a layer of platinum metal or other metals on the surface of the electrode site to further enhance the discharge capability or signal acquisition capability of the electrode site.
As shown in fig. 4, a method for preparing a stereoscopic flexible electrode for peripheral nerve directional space stimulation recording comprises the following steps:
s01, preparing a substrate: and cleaning the silicon wafer to ensure that the surface of the silicon wafer is clean and free of impurities.
S02, bottom metal deposition: and uniformly plating a layer of aluminum on the surface of the silicon wafer by using an electron beam evaporation process as a sacrificial layer.
S03, coating a first polyimide layer: polyimide is coated on the surface of a silicon wafer at a proper rotating speed to form a film.
S04, photolithography wire layer: the desired wiring pattern is formed on the polyimide by photolithography.
S05, metallization treatment: and plating chrome-gold metal on the silicon wafer by using electron beam evaporation to prepare a wire layer.
S06, pattern formation: the unwanted portions are removed with acetone to form the desired pattern.
S07, coating a second polyimide layer: polyimide is again applied to encapsulate the metal wires and provide protection.
S08, lithography profile layer: the desired electrode profile is formed by photolithographic techniques.
S09, metallization treatment: an electron beam evaporation process is used to plate an aluminum metal layer on the electrode as a mask layer.
S10, pattern formation: the sacrificial layer is removed by soaking with acetone to remove unwanted parts.
S11, outline etching: and etching by using a plasma etching system, and reserving the structure required by the electrode.
S12, electrolytic stripping: and stripping the bottom layer aluminum on the silicon wafer through an electrolysis process, so as to separate the electrodes.
Fig. 5 is a schematic diagram of a three-dimensional structure obtained by crimping the three-dimensional flexible electrode shown in fig. 1, wherein the implanted portion 1 comprises a strip-shaped structure, and the structure is lifted and separated when in use, and can be perpendicular to a nerve or form other angles with the nerve so as to further complete implantation of the electrode implanted portion. The wrapping portion 2 is crimped to form a nerve cuff that can be wrapped over the nerve to further complete implantation of the electrode wrapping portion. Specifically, the traction wire 3 can traction the implanted part 1 to the target position in the nerve through the traction hole 11, so that the electrode is guided to complete the implantation process, and finally the traction wire connected with the traction hole 1 can be further fixed on the nerve. The wrapping part 2 is provided with fixing holes 21, after wrapping the electrode wrapping part 2 on the nerve, the electrode is passed through the fixing holes 21 on two sides of the electrode by using the suture 4 and is bound, and the fixing holes 21 and the nerve adventitia can be sewn together, so that the electrode can be more stably fixed on the nerve.
FIG. 6 is a schematic diagram of electric field distribution of a stimulus current loop configured with wrap-around electrode sites in an embodiment of the invention; FIG. 7 is a schematic diagram of electric field distribution of a stimulation current loop configured by using electrode sites of a implanted portion in an embodiment of the present invention; fig. 8 is a schematic diagram of electric field distribution of a stimulation current loop configured with electrode sites of a implanted portion and a wrapped portion in an embodiment of the present invention. When the electrode is used for peripheral nerve stimulation, the electric field distribution of the stimulation current loop constructed by using different electrode sites is different, the electrode sites of the wrapping part 2 are used for stimulating and mainly easily activating peripheral nerve bundles near the adventitia, the electrode sites of the implantation part 1 are used for mainly easily activating deep nerve bundles in the nerve, and the electrode sites of the implantation part 1 and the wrapping part 2 are combined to selectively activate part of nerve bundles in a certain area. In actual use, different electrode sites can be configured to determine the optimal configuration scheme of the activation target site, so that the accurate activation of the target nerve bundles is realized, the activation of the rest nerve bundles is minimized, and the directional space selectivity of stimulation is improved.
Fig. 9 is a schematic diagram showing the effect of implanting the stereoscopic flexible electrode shown in fig. 1 into a peripheral nerve, and the method for implanting the stereoscopic flexible electrode into the peripheral nerve by using the peripheral nerve directional space stimulation record provided by the invention comprises the following steps:
1. exposing the peripheral nerve 5 to be implanted by a minimally invasive surgery;
2. the traction needle and the traction wire 3 penetrate through the traction hole of the electrode penetrating part, and the electrode penetrating part 1 is slowly separated;
3. implanting the electrode-implanted portion into the nerve bundle 6 by passing the outer membrane with a traction needle and a traction wire;
4. the electrode penetrating part 1 is penetrated out of the outer membrane of the nerve, and then the suture 4 is tied on the nerve for fixation;
5. bending the electrode wrapping portion 2 to wrap around the adventitia of the peripheral nerve;
6. the suture 4 is used for penetrating through the fixing holes at the two ends of the electrode and is tightly bound;
7. fixing a joint for connecting the electrode with external equipment at a specified position;
8. suturing the muscles and skin.
One embodiment of the invention is to implant the three-dimensional flexible electrode into the nerve of the upper limb to be tested in paralysis for peripheral nerve stimulation so as to reconstruct the hand movement function. The electrodes are distributed with 16 electrode sites, 8 sites are positioned on the implantation part, the other 8 sites are positioned on the wrapping part, the diameter of the electrode sites is 80 microns, and the interval between the two electrode sites is 300 microns. The electrode interface end is connected with one end of the flexible circuit board in a thermocompression bonding mode, the 1.27 mm interval row mother seat of the 2X 10Pin is connected with the other end of the flexible circuit board, and finally the electrode can be connected with external equipment through the row mother seat. After the electrodes are implanted into the skin nerve, ulnar nerve, median nerve and radial nerve of the tested muscle, the output end of the PlexonStim stimulator is connected with the electrodes, and the nerve activation muscles can be recruited by applying biphasic positive and negative charge balance pulse stimulation to different electrode sites, wherein the pulse amplitude is 100-500uA, the pulse width is 50-200us and the frequency is 50-100Hz, so that the actions of elbow bending, elbow stretching, wrist bending, wrist stretching, hand closing, hand opening and the like are completed. Wherein, because of the deep muscles that control the finger, the corresponding innervating nerve bundles are also located at the nerve center. Thus, when the electrode site stimulation of the wrapping portion fails to activate the deep finger muscle, the deep nerve can be stimulated with the electrode site of the implanted portion.
Furthermore, when the nerve bundles controlling different muscles in the implanted nerve are very dense, the stimulation sites of the implanted part can also activate one nerve bundle around the nerve bundles, so that other non-target muscles are activated to reduce the stimulation selectivity, at the moment, different stimulation current loops can be constructed through the configuration of the sites outside the membrane in the membrane to form different electric field distributions, so that the optimal electrode site configuration mode for forming the accurate stimulation target nerve bundles can be found, the target muscle can be activated as expected, the activation of other non-target nerve bundles nearby can be reduced, and the stimulation selectivity is further improved. After the optimal electrode site configuration corresponding to each muscle and joint movement is obtained, different actions can be combined by programming sequence stimulation through software of a control stimulation program to complete functional hand stretching and grasping movement, so that important part movement functions of the hand are rebuilt. In addition, the external interface of the electrode can be customized by means of wires, wireless communication and the like so as to meet different treatment requirements and technical requirements.
Fig. 10 is a schematic view of a three-dimensional flexible electrode structure for peripheral nerve directional space stimulation recording according to another embodiment of the present invention. As shown in the figure, the three-dimensional flexible electrode penetrating part for peripheral nerve directional space stimulation recording provided by the invention can also comprise two or more strips, when the penetrating part 1 comprises two strips, the two strips can be preferably designed into a herringbone planar structure layout, when in use, the herringbone strips can be lifted and separated firstly, and then the strips are folded in half along the middle line of the herringbone strips, so that electrode sites on two sides of the strips are in back-to-back contact, and the electrode sites on two sides of the implanted part are distributed after the implanted part is realized, nerve stimulation or nerve recording can be simultaneously carried out, and the same membrane internal stimulation effect as that of a transverse multichannel intra-bundle stimulation electrode (TIME) can be realized.
The foregoing embodiments have described in detail the technical solution and the advantages of the present invention, it should be understood that the foregoing embodiments are merely illustrative of the present invention and are not intended to limit the invention, and any modifications, additions and equivalents made within the scope of the principles of the present invention should be included in the scope of the invention.
Claims (9)
1. The stereoscopic flexible electrode for peripheral nerve directional space stimulation recording is characterized by comprising a flexible implantation part and a wrapping part, wherein the wrapping part is provided with a notch matched with the outline of the implantation part; the embedded part is embedded in the notch, the embedded part is a strip-shaped structure with one end connected and fixed with the wrapping part, and the other end of the strip-shaped structure is pointed;
the implantation part is used for penetrating the nerve membrane and being implanted into the nerve bundle, and the wrapping part is used for being wrapped and fixed on the nerve adventitia in a curling way;
the penetrating part and the wrapping part comprise a basal layer, a covering layer and a wire layer positioned between the basal layer and the covering layer; the covering layers of the penetrating part and the wrapping part are respectively provided with a plurality of electrode sites, and the electrode sites are respectively connected to the electrode interfaces through wires on the corresponding wire layers; the electrode interface is connected with external equipment.
2. The stereotactic spatially-stimulated recorded stereoscopic flexible electrode according to claim 1, wherein the electrode sites of the implanted portion are in contact with the nerve bundles within the nerve membrane after electrode implantation, and the electrode sites of the wrapped portion are in contact with the adventitia; the current pulse is transmitted into the nerve through the electrode sites of the implantation part and the wrapping part to perform nerve electrical stimulation or the nerve signal is collected to external equipment to perform nerve recording; or the electrode sites of the implantation part and the wrapping part are subjected to joint optimization configuration to construct a fine current loop, so that space directional stimulation and recording are realized.
3. The stereotactic nerve-oriented spatial stimulation recorded stereoscopic flexible electrode according to claim 1, wherein the pointed portion of the implanted portion is provided with a pulling hole for pulling the implanted portion up from the notch of the wrapped portion and securing it to the nerve.
4. The stereotactic nerve space stimulating recording stereotactic flexible electrode according to claim 1, wherein both sides of said wrapping portion are provided with fixing holes for fixing the wrapping portion when the wrapping portion wraps the outer membrane of the nerve.
5. The stereotactic spatially-stimulated recorded stereoscopic flexible electrode of claim 1, wherein said implanted portion comprises at least one stripe-like structure; when the strip-shaped structures are two or more, the two or more strip-shaped structures are symmetrically folded when in use.
6. The stereotactic nerve space stimulating recording stereotactic flexible electrode according to claim 1, wherein said implanted portion is perpendicular or parallel to both sides of the wrapping portion according to the use requirement.
7. The stereotactic spatially stimulated recording stereoscopic flexible electrode of claim 1, wherein the material of said base layer and cover layer is any one of polyimide, polydimethylsiloxane, parylene, epoxy, polyamideimide, SU-8 photoresist, silicone gel, silicone rubber, or a combination thereof.
8. The stereotactic spatially-stimulated recording stereoscopic flexible electrode of claim 1, wherein said electrode sites are comprised of a conductive material comprising at least one of gold, platinum, iridium, tungsten, platinum iridium alloy, titanium alloy, graphite, carbon nanotubes, PEDOT.
9. The preparation method of the stereoscopic flexible electrode for peripheral nerve directional space stimulation recording is characterized by comprising the following steps of:
coating a substrate layer on a silicon wafer, and etching and depositing to obtain a wire layer;
etching to remove redundant parts after coating the covering layer, including cutting through the boundary between the implanted part and the wrapping part, and reserving a required structure;
finally, the electrode is separated from the silicon wafer, and the implanted part and the wrapping part are gently separated when the electrode is used.
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US20040024439A1 (en) * | 2000-10-11 | 2004-02-05 | Riso Ronald R. | Nerve cuff electrode |
CN110841186A (en) * | 2019-11-19 | 2020-02-28 | 华中科技大学 | Implanted peripheral nerve electrode |
EP3641629A1 (en) * | 2017-06-22 | 2020-04-29 | Galvani Bioelectronics Limited | Nerve stimulation and monitoring device |
CN111939472A (en) * | 2020-08-10 | 2020-11-17 | 中国科学院上海微系统与信息技术研究所 | Intracranial stimulation recording system and preparation method thereof |
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US20040024439A1 (en) * | 2000-10-11 | 2004-02-05 | Riso Ronald R. | Nerve cuff electrode |
EP3641629A1 (en) * | 2017-06-22 | 2020-04-29 | Galvani Bioelectronics Limited | Nerve stimulation and monitoring device |
CN110841186A (en) * | 2019-11-19 | 2020-02-28 | 华中科技大学 | Implanted peripheral nerve electrode |
CN111939472A (en) * | 2020-08-10 | 2020-11-17 | 中国科学院上海微系统与信息技术研究所 | Intracranial stimulation recording system and preparation method thereof |
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