CN113041496A - Nerve electrical stimulation electrode, preparation method and implantation method thereof - Google Patents
Nerve electrical stimulation electrode, preparation method and implantation method thereof Download PDFInfo
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- CN113041496A CN113041496A CN202110297544.9A CN202110297544A CN113041496A CN 113041496 A CN113041496 A CN 113041496A CN 202110297544 A CN202110297544 A CN 202110297544A CN 113041496 A CN113041496 A CN 113041496A
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- A—HUMAN NECESSITIES
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36103—Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
Abstract
The invention provides a nerve electrical stimulation electrode, a preparation method and an implantation method thereof, wherein the electrode comprises a base insulating layer, a conducting layer and a top insulating layer which are arranged in a stacked mode, the electrode is divided into an implantation section and a connecting section along the length direction, the width of the implantation section is smaller than that of the connecting section, the conducting layer comprises a positioning implantation ring, at least two electrode plates and a connecting wire, the electrode plates comprise a contact point positioned in the implantation section and a connecting point positioned in the connecting section, and the contact point is connected with the connecting point through the connecting wire; the positioning implantation ring is positioned at one end, far away from the connecting section, of the implantation section, the positioning hole is formed in the substrate insulating layer and the top insulating layer at the position of the positioning implantation ring, the contact is exposed through the exposure hole, and the connecting point is connected with the connecting contact piece through the connecting hole. Compared with the prior art, the invention can be processed in batches and has low cost, and the positioning holes are further arranged for accurate positioning.
Description
Technical Field
The invention belongs to the technical field of electrodes, and particularly relates to a nerve electrical stimulation electrode, a preparation method and an implantation method thereof.
Background
Deep brain electrical stimulation stimulates specific functional nerve nuclei of the brain, such as thalamus ventral nucleus, globus pallidus ventral nucleus, subthalamic nucleus and the like by sending high-frequency weak electric pulses, directly changes the discharge frequency and mode of neurons near electrodes, and influences thalamocortical loops and downstream channels thereof, thereby eliminating symptoms of neurological diseases. Deep brain electrical stimulation is applicable to various neurological diseases, including Parkinson's disease, epilepsy, Alzheimer's disease, tremor, torsion spasm and the like. The deep brain electrical stimulation has adjustability, and stimulation parameters including delivery amplitude, frequency, pulse width and the like can be adjusted according to symptoms. In addition, the method has long curative effect, small damage to the brain and reversible effect, thereby becoming an ideal therapy for various neurological diseases.
A deep brain electrical stimulation system, also known as a brain pacemaker, comprises three main components, namely a pulse generator, an extension lead and an electrical stimulation electrode. The electric stimulation electrode is implanted in the brain, the pulse generator is implanted under the front skin of the chest, and the extension lead is connected with the electric stimulation electrode and the pulse generator under the skin. Among them, the electro-stimulation electrode implanted into the brain is the most important part in the whole brain pacemaker system, and the performance of the electro-stimulation electrode directly influences the electro-stimulation effect. The conventional electric stimulation electrode is mostly an insulated thin wire, the conductive part is made of platinum and iridium or other metal materials, the outer layer is made of a biocompatible polymer material and serves as a protective sleeve, four or eight stimulation sites are arranged at the tip of the electrode, and pulse signals are sent to stimulate target points through the stimulation sites. At present, the conventional manufacturing method of the electrical stimulation electrode relates to operation steps such as hot forming or spot welding, and has the problems of long processing time, difficult batch production and high price. Therefore, how to mass produce the deep brain stimulation electrode which is low in price and high in efficiency and can be matched with the conventional brain pacing equipment becomes a problem to be solved urgently.
CN104340956A discloses an implantable multi-channel flexible micro-tube electrode and a preparation method thereof, the method steps include: firstly, manufacturing a flexible film electrode; and secondly, intercepting the polymer capillary, cleaning and drying, uniformly coating biocompatible adhesive on the outer wall surface of the polymer capillary, tightly winding and fixing the manufactured flexible thin film electrode on the outer wall surface of the polymer capillary at an angle along the length direction of the polymer capillary, and curing the adhesive to obtain the implantable multi-channel flexible micro-tube electrode. The implantable multi-channel flexible micro-tube electrode prepared by the invention can simultaneously carry out functional electrical stimulation and electrical signal recording on nerve and muscle tissues, and can controllably administer drugs into biological tissues through a micro-fluid channel.
CN109908467A discloses a nerve electrical stimulation electrode assembly and a preparation method thereof, the nerve electrical stimulation electrode assembly comprises a soluble glue, an electrode catheter and a puncture tube. The electrode catheter includes a protection tube and a first fixing member including a first fixing portion and a first fixing wing. The first fixing part is fixedly sleeved on the protection tube. The first stationary vane includes a first fixed end and a first free end. The first fixed end is connected with one end of the first fixed part. The first free end is attached to the protective tube by the dissolvable glue. The puncture tube is sleeved on the electrode catheter. When the electrode catheter is implanted into a target tissue and reaches a target point, the soluble glue is gradually dissolved by contacting body fluid and loses viscosity, so that the first free end is automatically opened and embedded into the target tissue, and the electrode catheter and the target tissue are fixed.
The existing electrical stimulation electrodes all have the problems of large size, complex manufacturing, high cost and the like, so that the problem that how to ensure that the electrical stimulation electrodes have the characteristics of small size and the like under the conditions of simple manufacturing and low cost is solved urgently at present.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a nerve electrical stimulation electrode, a preparation method and an implantation method thereof.
In order to achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the invention provides a nerve electrical stimulation electrode, which comprises a base insulating layer, a conducting layer and a top insulating layer which are arranged in a stacked mode, wherein the electrode is divided into an implantation section and a connecting section along the length direction, the width of the implantation section is smaller than that of the connecting section, the conducting layer comprises a positioning implantation ring, at least two electrode plates and a connecting line, the electrode plates comprise a contact point located in the implantation section and a connecting point located in the connecting section, and the contact point and the connecting point are connected through the connecting line; the positioning implantation ring is positioned at one end of the implantation section far away from the connection section, and positioning holes are formed in the base insulating layer and the top insulating layer at the position of the positioning implantation ring; the top insulating layer is provided with an exposing hole at the corresponding position of the contact, and the contact is exposed through the exposing hole; the top insulating layer is provided with a connecting hole, the connecting hole upper cover is provided with a connecting contact piece, and the connecting point is connected with the connecting contact piece through the connecting hole.
The base insulating layer, the conducting layer and the top insulating layer are arranged in a stacked mode, the base insulating layer, the conducting layer and the top insulating layer are manufactured in sequence, the structural design is more flexible, the nerve electrical stimulation electrode can be processed in batches, the cost is lower, the size is smaller than that of a commercial electrode in the prior art, damage to brain tissues is small, the electrode is accurately positioned by arranging the positioning hole, and therefore good stimulation is conducted on a brain area on one side of the electrode, adjacent brain areas are well prevented from being activated, and side effects are reduced.
As a preferred technical solution of the present invention, the electrode further includes a switching structure, and the switching structure is used for connecting the electrode with different adapting terminals.
The electrode of the invention can be connected with commercial equipment by arranging the switching structure, thereby improving the applicability of the invention.
Preferably, the switching structure is cylindrical and is positioned at the connecting section, the base insulating layer and the top insulating layer cover the periphery of the switching structure, and one side of the base insulating layer is attached to the switching structure.
In the invention, the electrode and the switching structure are mutually attached through the acting force between the materials, and other materials such as adhesive and the like are not needed.
Preferably, the material of the adapting structure comprises a first flexible polymer material with biocompatibility.
Preferably, the first flexible polymer material comprises any one of silicone rubber, polyurethane or polydimethylsiloxane or a combination of at least two of the silicone rubber, the polyurethane and the polydimethylsiloxane.
As a preferred technical solution of the present invention, the electrode further includes an auxiliary implant, and the auxiliary implant is used for penetrating into the positioning hole to assist the implantation of the electrode.
Preferably, the auxiliary implant is needle-shaped.
Preferably, the auxiliary implant is made of tungsten and/or stainless steel.
Preferably, the width of the implanted section is 0.02-2 mm, for example, 0.02mm, 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm or 2.0 mm.
Preferably, the connecting section has a width of 0.05 to 4mm, for example, a width of 0.05mm, 0.4mm, 0.8mm, 1.2mm, 1.6mm, 2.0mm, 2.4mm, 2.8mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0 mm.
Preferably, the thickness of the implant section and the connecting section is 1-20 μm, for example, the thickness is 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 13 μm, 14 μm, 15 μm, 16 μm, 17 μm, 18 μm, 19 μm or 20 μm.
As a preferred embodiment of the present invention, the contacts are linearly arranged on the implantation section along the length direction of the electrode.
Preferably, the connection points are linearly arranged on the connection section along the length direction of the electrode.
Preferably, the number of contacts is 2 to 1000, for example, 2, 10, 50, 100, 200, 300, 400, 500, 600, 700, 800, 900 or 1000.
Preferably, the distance between adjacent contacts is 0.01 to 25mm, for example, the distance is 0.01mm, 0.05mm, 0.1mm, 0.5mm, 1.0mm, 5.0mm, 7.0mm, 9.0mm, 11.0mm, 13.0mm, 15.0mm, 17.0mm, 19.0mm, 21.0mm, 23.0mm or 25.0 mm.
Preferably, the surface of the contact is subjected to a finishing treatment.
The surface of the contact is modified, so that the stimulation effect can be enhanced.
Preferably, the material of the modification treatment includes a conductive polymer and/or conductive metal particles.
Preferably, the modification treatment comprises electrodeposition and/or self-assembly.
Preferably, the conductive polymer comprises polydioxyethylthiophene-polyparaphenylenesulfonic acid and/or polypyrrole.
Preferably, the material of the conductive metal particles includes one of iridium, platinum or platinum-iridium alloy.
In a preferred embodiment of the present invention, the material of the base insulating layer and the top insulating layer includes a second flexible polymer material having biocompatibility.
The invention can reduce the immunoreaction of the tissue by using the polymer material with good biocompatibility, and has the advantage of long-term stability.
Preferably, the second flexible polymer material comprises any one of polyimide, SU-8 or parylene or a combination of at least two of the above.
It should be noted that SU-8 is a negative, epoxy type, and near ultraviolet photoresist.
Preferably, the base insulating layer and the top insulating layer are made of the same or different materials.
Preferably, the material of the contact, the connecting wire, the connecting point and the positioning implantation ring comprises any one or a combination of at least two of platinum, iridium or gold.
Preferably, the contact, the connecting wire, the connecting point and the positioning implantation ring are made of the same or different materials.
In a second aspect, the present invention also provides a method for preparing the neural electric stimulation electrode according to the first aspect, wherein the method for preparing the neural electric stimulation electrode comprises:
preparing a metal contact, a connecting wire, a connecting point and a positioning implantation ring on a substrate insulating layer, coating a top insulating layer on the surface of one side of the substrate insulating layer, which is provided with the contact, the connecting wire, the connecting point and the positioning implantation ring, respectively perforating corresponding positions of the contact and the connecting point on the top insulating layer to expose the contact and the connecting point, arranging positioning holes at the positions of the substrate insulating layer and the top insulating layer, which are positioned on the positioning implantation ring, and connecting the connecting point and a connecting contact point sheet.
As a preferred technical scheme of the invention, the preparation method specifically comprises the following steps:
processing a substrate insulating layer shape on a carrier and arranging a sacrificial layer, and spin-coating a flexible high polymer material to form the substrate insulating layer;
(II) processing patterns of the contact, the connecting wire, the connecting point and the positioning implantation ring on the surface of the substrate insulating layer, and processing metal on the patterns to form the contact, the connecting wire, the connecting point and the positioning implantation ring;
(III) spin-coating a flexible high polymer material on the surface of one side, provided with a contact, a connecting wire, a connecting point and a positioning implantation ring, of the substrate insulating layer to form a top insulating layer, coating photoresist to form a pattern to protect the whole electrode structure, and removing the substrate insulating layer and the top insulating layer which are not protected by the photoresist;
(IV) removing the photoresist to expose the contact and the connecting point, coating the connecting wire and the positioning implantation ring by the substrate insulating layer and the top insulating layer, processing the surface of the top insulating layer to form a pattern of a connecting contact sheet, arranging metal on the pattern to form the connecting contact sheet, connecting the connecting point with the connecting contact sheet, scribing and removing the sacrificial layer to obtain the nerve electrical stimulation electrode.
As a preferred technical solution of the present invention, in the step (i), the processing manner of the shape of the insulating base layer includes an ultraviolet lithography process and an etching process.
Preferably, in step (i), the processing manner of the sacrificial layer includes magnetron sputtering coating and/or electron beam evaporation.
Preferably, in step (i), the spin coating is followed by heating.
Preferably, in step (ii), the processing modes of the contact, the connecting line, the connecting point and the positioning implantation ring pattern comprise an ultraviolet lithography process and a developing process.
Preferably, in step (ii), the metal is processed in the form of electron beam evaporation or thermal evaporation.
Preferably, in step (iii), the shape processing manner of the top insulating layer includes an ultraviolet lithography process and an etching process.
It should be noted that, in the present invention, when processing metal, it is known to those skilled in the art that the stripping process is necessarily included, which is not a main innovation of the present invention, and the present invention does not have to be specifically required and limited to the stripping process.
According to the invention, by adopting micro-nano processing technologies such as an ultraviolet lithography technology, a magnetron sputtering coating, an electron beam evaporation metal layer, an etching technology, a stripping technology and the like, the base insulating layer is firstly manufactured, then the electrode plate and the positioning implantation ring are arranged on the base insulating layer, and finally the structure of the top insulating layer is arranged, so that the structural design of the electrode is flexible, and the electrode has the characteristics of simple and convenient processing technology, low cost, high efficiency, batch production and the like.
In a third aspect, the present invention provides a method of implanting a neurostimulation electrode according to the first aspect, wherein the method of implanting comprises:
and determining an implantation position by the positioning hole, and implanting the implantation section of the electrode into a target.
As a preferred technical solution of the present invention, the implantation method specifically includes the steps of:
the auxiliary implant penetrates into the positioning hole, the positioning hole determines the implantation position, the implantation section of the electrode is implanted into the target through the auxiliary implant, and the auxiliary implant is taken out; and covering and attaching the connecting section on one side of the base insulating layer on the outer surface of the switching structure, and connecting the connecting section with the adaptive terminal.
The recitation of numerical ranges herein includes not only the above-recited numerical values, but also any numerical values between non-recited numerical ranges, and is not intended to be exhaustive or to limit the invention to the precise numerical values encompassed within the range for brevity and clarity.
Compared with the prior art, the invention has the beneficial effects that:
the base insulating layer, the conducting layer and the top insulating layer are arranged in a stacked mode, the base insulating layer, the conducting layer and the top insulating layer are manufactured in sequence, the structural design is more flexible, the nerve electrical stimulation electrode can be processed in batches, the cost is lower, the size is smaller than that of a commercial electrode in the prior art, damage to brain tissues is small, the electrode is accurately positioned by arranging the positioning hole, and therefore good stimulation is conducted on a brain area on one side of the electrode, adjacent brain areas are well prevented from being activated, and side effects are reduced.
Drawings
Fig. 1 is a schematic structural diagram of a neural electrical stimulation electrode provided in one embodiment of the present invention;
FIG. 2 is a schematic diagram illustrating a layered decomposition of a neurostimulation electrode provided in one embodiment of the present invention;
FIG. 3 is a schematic view of a transition structure provided in an embodiment of the present invention;
fig. 4 is a schematic diagram of implantation of the neurostimulation electrode provided in application example 1 of the invention.
Wherein, 1-a base insulating layer; 2-a top insulating layer; 3-contact; 4-a junction point; 5-connecting wires; 6-positioning the implantation ring; 7-connecting hole; 8-connecting the contact sheet; 9-a connecting segment; 10-an implantation section; 11-an auxiliary implant; 12-positioning holes; 13-a transfer structure; 14-exposing the pores.
Detailed Description
It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be taken as limiting the present invention.
It should be noted that, in the description of the present invention, unless otherwise explicitly specified or limited, the terms "disposed," "connected" and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.
The technical solution of the present invention is further explained by the following embodiments.
In one embodiment, the invention provides a nerve electrical stimulation electrode, as shown in fig. 1 and fig. 2, the electrode comprises a base insulating layer 1, a conducting layer and a top insulating layer 2 which are arranged in a stacked manner, the electrode is divided into an implantation section 10 and a connection section 9 along the length direction, the width of the implantation section 10 is smaller than that of the connection section 9, the conducting layer comprises a positioning implantation ring 6, at least two electrode plates and a connecting wire 5, the electrode plates comprise a contact 3 positioned on the implantation section 10 and a connecting point 4 positioned on the connection section 9, and the contact 3 and the connecting point 4 are connected through the connecting wire 5; the positioning implantation ring 6 is positioned at one end of the implantation section 10 far away from the connecting section 9, and positioning holes 12 are formed in the base insulating layer 1 and the top insulating layer 2 at the positions where the positioning implantation ring 6 is positioned; the top insulating layer 2 is provided with an exposing hole 14 at a position corresponding to the contact 3, and the contact 3 is exposed through the exposing hole 14; and the top insulating layer 2 is provided with a connecting hole 7 at the position corresponding to the connecting point 4, a connecting contact sheet 8 is covered on the connecting hole 7, and the connecting point 4 is connected with the connecting contact sheet 8 through the connecting hole 7.
According to the invention, the contact 3, the connecting wire 5 and the connecting point 4 are arranged between the base insulating layer 1 and the top insulating layer 2, the base insulating layer 1, the electrode plate and the top insulating layer 2 are sequentially manufactured, the structural design is more flexible, the nerve electrical stimulation electrode can be processed in batch, the cost is lower, the size is smaller than that of a commercial electrode in the prior art, the damage to brain tissues is small, and the positioning hole 12 is further arranged to accurately position the electrode, so that the brain area on one side of the electrode is well stimulated, the adjacent brain areas are well prevented from being activated, and the side effect is reduced.
Further, as shown in fig. 3, the electrode further includes a adapting structure 13, and the adapting structure 13 is used for connecting the electrode with different adapting terminals. The adapting structure 13 is cylindrical and is positioned at the periphery of the adapting structure 13 coated by the base insulating layer 1 and the top insulating layer 2 of the connecting section 9, and one side of the base insulating layer 1 is attached to the adapting structure 13. The material of the adapting structure 13 includes a first flexible polymer material with biocompatibility. The first flexible high polymer material comprises any one of silicon rubber, polyurethane or polydimethylsiloxane or a combination of at least two of the silicon rubber, the polyurethane and the polydimethylsiloxane. The electrode of the invention can be connected with commercial equipment by arranging the switching structure 13, thereby improving the applicability of the invention.
Further, the electrode also comprises an auxiliary implant 11, and the auxiliary implant 11 is used for penetrating into the positioning hole 12 to assist the implantation of the electrode. Further, the auxiliary implant 11 is needle-shaped and is made of tungsten and/or stainless steel.
Furthermore, the width of the implantation section 10 is 0.02-2 mm, the width of the connection section 9 is 0.05-4 mm, and the thickness of the implantation section 10 and the thickness of the connection section 9 are both 1-20 μm.
Further, the contacts 3 are linearly arranged on the implantation section 10 along the length direction of the electrode, and the connection points 4 are linearly arranged on the connection section 9 along the length direction of the electrode. The number of the contacts 3 is 2-1000. The distance between adjacent contacts 3 is 0.01-25 mm.
Further, the surface of the contact 3 is subjected to a finishing treatment. The material of the modification treatment comprises conductive polymer and/or conductive metal particles, the modification treatment mode comprises electrodeposition and/or self-assembly, the conductive polymer comprises polydioxyethyl thiophene-poly-p-styrene sulfonic acid and/or polypyrrole, and the material of the conductive metal particles comprises one of iridium, platinum or platinum-iridium alloy. The present invention can enhance the stimulation effect by performing the modification treatment on the surface of the contact 3.
Further, the material of the base insulating layer 1 and the top insulating layer 2 includes a second flexible polymer material with biocompatibility. The second flexible high polymer material comprises any one or a combination of at least two of polyimide, SU-8 or parylene. The base insulating layer 1 and the top insulating layer 2 may be made of the same material or different materials. The invention can reduce the immunoreaction of the tissue by using the polymer material with good biocompatibility, and has the advantage of long-term stability.
Further, the material of the contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6 comprises any one or a combination of at least two of platinum, iridium or gold. The contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6 are made of the same or different materials.
In another embodiment, the invention further provides a preparation method of the above neural electric stimulation electrode, and the preparation method specifically comprises the following steps:
processing a substrate insulating layer 1 shape on a carrier and arranging a sacrificial layer, and spin-coating a flexible high polymer material to form the substrate insulating layer 1;
(II) processing patterns of the contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6 on the surface of the base insulating layer 1, and processing metal on the patterns to form the contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6;
(III) spin-coating a flexible high polymer material on the surface of one side, provided with the contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6, of the substrate insulating layer 1 to form a top insulating layer 2, coating a photoresist to form a pattern to protect the whole electrode structure, and removing the substrate insulating layer 1 and the top insulating layer 2 which are not protected by the photoresist;
(IV) removing the photoresist, exposing the contact 3 and the connecting point 4, coating the connecting wire 5 and the positioning implantation ring 6 by the base insulating layer 1 and the top insulating layer 2, processing the surface of the top insulating layer 2 to form a pattern of a connecting contact sheet 8, arranging metal on the pattern to form the connecting contact sheet 8, connecting the connecting point with the connecting contact sheet, scribing and removing the sacrificial layer to obtain the nerve electrical stimulation electrode.
In the step (I), the processing mode of the shape of the substrate insulating layer 1 comprises an ultraviolet photoetching process and an etching process; the processing mode of the sacrificial layer comprises magnetron sputtering coating and/or electron beam evaporation; heating is performed after spin coating.
In the step (II), the processing modes of the patterns of the contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6 comprise an ultraviolet photoetching process and a developing process; the processing form of the metal is electron beam evaporation or thermal evaporation.
In the step (iii), the shape processing manner of the top insulating layer 2 includes an ultraviolet lithography process and/or an etching process.
According to the invention, by adopting micro-nano processing technologies such as an ultraviolet lithography technology, a magnetron sputtering coating, an electron beam evaporation metal layer, an etching technology, a stripping technology and the like, the base insulating layer 1 is firstly manufactured, then the electrode plate and the positioning implantation ring 6 are arranged on the base insulating layer 1, and finally the structure of the top insulating layer 2 is arranged, so that the structural design of the electrode is flexible, and the electrode has the characteristics of simple and convenient processing technology, low cost, high efficiency, batch production and the like.
Example 1
The embodiment provides a nerve electrical stimulation electrode, which is based on the nerve electrical stimulation electrode in a specific embodiment, wherein the number of electrode slices is 4, the distance between adjacent contacts 3 is 1.5mm, the width of an implantation section 10 is 0.5mm, the width of a connection section 9 is 3.5mm, and the thicknesses of the implantation section 10 and the connection section 9 are both 12.5 μm; the material of the base insulating layer 1 is polyimide, the material of the top insulating layer 2 is parylene, the material of the contact 3 is platinum, the material of the connecting wire 5 is gold, the material of the connecting point 4 is gold, and the material of the positioning implantation ring 6 is gold. The material of the adapting structure 13 is polyurethane.
The material for modification treatment is polydioxyethyl thiophene-poly (p-phenylethenesulfonic acid), and the modification treatment mode is electrodeposition.
The embodiment also provides a preparation method of the nerve electrical stimulation electrode, which is based on the preparation method described in a specific embodiment, wherein in the step (i), the processing mode of the shape of the base insulating layer 11 is an ultraviolet lithography process and an etching process. The processing mode of the sacrificial layer is magnetron sputtering coating; in the step (II), the processing modes of the patterns of the contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6 are an ultraviolet photoetching process and a developing process; the metal is processed in the form of thermal evaporation. In the step (iii), the shape processing manner of the top insulating layer 2 includes an ultraviolet lithography process and/or an etching process.
Example 2
The embodiment provides a nerve electrical stimulation electrode, which is based on the nerve electrical stimulation electrode in a specific embodiment, wherein the number of electrode slices is 2, the distance between adjacent contacts 3 is 25mm, the width of an implantation section 10 is 1mm, the width of a connection section 9 is 3.8mm, and the thicknesses of the implantation section 10 and the connection section 9 are both 5 μm; the base insulating layer 1 is made of polyimide, the top insulating layer 2 is made of polyimide, the contact 3 is made of platinum, the connecting wire 5 is made of gold, the connecting point 4 is made of gold, and the positioning implantation ring 6 is made of platinum. The material of the adapting structure 13 is silicon rubber.
The material of the modification treatment is polypyrrole, and the mode of the modification treatment is electrodeposition.
The embodiment also provides a preparation method of the nerve electrical stimulation electrode, which is based on the preparation method described in a specific embodiment, wherein in the step (i), the processing mode of the shape of the base insulating layer 11 is an ultraviolet lithography process and an etching process. The processing mode of the sacrificial layer is magnetron sputtering coating; in the step (II), the processing mode of the patterns of the contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6 is an ultraviolet photoetching process; the processing form of the metal is electron beam evaporation. In the step (iii), the shape processing manner of the top insulating layer 2 includes an ultraviolet lithography process and an etching process.
Example 3
The embodiment provides a nerve electrical stimulation electrode, which is based on the nerve electrical stimulation electrode in a specific embodiment, wherein the number of electrode slices is 1000, the distance between adjacent contacts 3 is 0.02mm, the width of an implantation section 10 is 2mm, the width of a connection section 9 is 3.5mm, and the thicknesses of the implantation section 10 and the connection section 9 are both 20 μm; the base insulating layer 1 is made of SU-8, the top insulating layer 2 is made of parylene, the contact 3 is made of gold, the connecting wire 5 is made of platinum, the connecting point 4 is made of iridium, and the positioning implantation ring 6 is made of platinum. The material of the adapting structure 13 is polydimethylsiloxane.
The material of the modification treatment is conductive metal particles, the material is platinum-iridium alloy, and the modification treatment mode is self-assembly.
The embodiment also provides a preparation method of the nerve electrical stimulation electrode, which is based on the preparation method described in a specific embodiment, wherein in the step (i), the processing mode of the shape of the base insulating layer 11 is an ultraviolet lithography process and an etching process. The processing mode of the sacrificial layer is electron beam evaporation; in the step (II), the processing modes of the patterns of the contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6 are an ultraviolet photoetching process, a developing process and a stripping process; the processing form of the metal is electron beam evaporation. In the step (iii), the top insulating layer 2 is processed in the form of an ultraviolet lithography process and an etching process.
Example 4
The embodiment provides a nerve electrical stimulation electrode, which is based on the nerve electrical stimulation electrode in a specific embodiment, wherein the number of electrode slices is 20, the distance between adjacent contacts 3 is 0.01mm, the width of an implantation section 10 is 0.02mm, the width of a connection section 9 is 0.05mm, and the thicknesses of the implantation section 10 and the connection section 9 are both 1 μm; the base insulating layer 1 is made of SU-8, the top insulating layer 2 is made of parylene, the contact 3 is made of gold, the connecting wire 5 is made of platinum, the connecting point 4 is made of iridium, and the positioning implantation ring 6 is made of platinum. The material of the adapting structure 13 is polydimethylsiloxane.
The material of the modification treatment is conductive metal particles, the material is platinum, and the modification treatment mode is self-assembly.
The embodiment also provides a preparation method of the nerve electrical stimulation electrode, which is based on the preparation method described in a specific embodiment, wherein in the step (i), the processing mode of the shape of the base insulating layer 11 is an ultraviolet lithography process and an etching process. The processing mode of the sacrificial layer is electron beam evaporation; in the step (II), the processing modes of the patterns of the contact 3, the connecting wire 5, the connecting point 4 and the positioning implantation ring 6 are an ultraviolet photoetching process, a developing process and a stripping process; the processing form of the metal is electron beam evaporation. In the step (iii), the top insulating layer 2 is processed in the form of an ultraviolet lithography process and an etching process.
Application example 1
The application example provides an implantation method of the neural electrical stimulation electrode according to the above embodiment, and the use method specifically includes the following steps:
as shown in fig. 4, (i) inserting the auxiliary implant 11 into the positioning hole 12, the positioning hole 12 defining an implantation position, implanting the implantation section 10 of the electrode into the target by guiding the auxiliary implant 11, and taking out the auxiliary implant 11, the electrode remaining in the target;
and (II) coating and attaching the connecting section 9 on one side of the base insulating layer 1 on the outer surface of the adapter structure 13, and connecting with an adaptive terminal.
Through the above embodiment and application example, the contact 3, the connecting wire 5 and the connecting point 4 are arranged between the base insulating layer 1 and the top insulating layer 2, the base insulating layer 1, the electrode plate and the top insulating layer 2 are sequentially manufactured, the structural design is more flexible, the nerve electrical stimulation electrode can be processed in batch, the cost is lower, the size is smaller than that of a commercial electrode in the prior art, the damage to brain tissues is small, the electrode is accurately positioned by arranging the positioning hole 12, the brain area on one side of the electrode is well stimulated, the adjacent brain area is well prevented from being activated, and the side effect is reduced.
The applicant declares that the above description is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and it should be understood by those skilled in the art that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are within the scope and disclosure of the present invention.
Claims (10)
1. The nerve electrical stimulation electrode is characterized by comprising a base insulating layer, a conducting layer and a top insulating layer which are arranged in a stacked mode, the electrode is divided into an implantation section and a connecting section along the length direction, the width of the implantation section is smaller than that of the connecting section, the conducting layer comprises a positioning implantation ring, at least two electrode plates and a connecting line, each electrode plate comprises a contact located in the implantation section and a connecting point located in the connecting section, and the contacts and the connecting points are connected through the connecting line;
the positioning implantation ring is positioned at one end of the implantation section far away from the connection section, and positioning holes are formed in the base insulating layer and the top insulating layer at the position of the positioning implantation ring;
the top insulating layer is provided with an exposing hole at the corresponding position of the contact, and the contact is exposed through the exposing hole;
the top insulating layer is provided with a connecting hole, the connecting hole upper cover is provided with a connecting contact piece, and the connecting point is connected with the connecting contact piece through the connecting hole.
2. The electrostimulation electrode to the nerve according to claim 1, characterised in that the electrode further comprises a transition structure for connecting the electrode to different fitting terminals;
preferably, the switching structure is cylindrical, the base insulating layer and the top insulating layer are positioned at the connecting section and wrap the periphery of the switching structure, and one side of the base insulating layer is attached to the switching structure;
preferably, the material of the adapting structure comprises a first flexible polymer material with biocompatibility;
preferably, the first flexible polymer material comprises any one of silicone rubber, polyurethane or polydimethylsiloxane or a combination of at least two of the silicone rubber, the polyurethane and the polydimethylsiloxane.
3. The electrostimulation neural electrode according to claim 1 or 2, characterised in that the electrode further comprises an auxiliary implant for assisting the implantation of the electrode through the pilot hole of the electrode;
preferably, the auxiliary implant is needle-shaped;
preferably, the auxiliary implant is made of tungsten and/or stainless steel;
preferably, the width of the implantation section is 0.02-2 mm;
preferably, the width of the connecting section is 0.05-4 mm;
preferably, the thickness of the implantation section and the thickness of the connection section are both 1-20 μm.
4. The electrostimulation electrode according to any of the claims 1 to 3, characterised in that the contacts are arranged linearly along the length of the electrode on the implanted section;
preferably, the connection points are linearly arranged on the connection section along the length direction of the electrode;
preferably, the number of the contacts is 2-1000;
preferably, the distance between the adjacent contacts is 0.01-25 mm;
preferably, the surface of the contact is subjected to a finishing treatment;
preferably, the material subjected to the modification treatment comprises a conductive polymer and/or conductive metal particles;
preferably, the modification treatment comprises electrodeposition and/or self-assembly;
preferably, the conductive polymer comprises polydioxyethylthiophene-polyparaphenylenesulfonic acid and/or polypyrrole;
preferably, the material of the conductive metal particles includes one of iridium, platinum or platinum-iridium alloy.
5. The electrical nerve stimulation electrode as claimed in any one of claims 1 to 4, wherein the material of the base insulating layer and the top insulating layer comprises a second flexible polymer material with biocompatibility;
preferably, the second flexible polymer material comprises any one of polyimide, SU-8 or parylene or a combination of at least two of the polyimide, the SU-8 and the parylene;
preferably, the base insulating layer and the top insulating layer are made of the same or different materials;
preferably, the contact, the connecting wire, the connecting point and the positioning implantation ring are made of any one or a combination of at least two of platinum, iridium or gold;
preferably, the contact, the connecting wire, the connecting point and the positioning implantation ring are made of the same or different materials.
6. A method for preparing the electrostimulation electrode for nerves according to any of claims 1 to 5, characterized in that the method for preparing comprises:
preparing a metal contact, a connecting wire, a connecting point and a positioning implantation ring on a substrate insulating layer, coating a top insulating layer on the surface of one side of the substrate insulating layer, which is provided with the contact, the connecting wire, the connecting point and the positioning implantation ring, respectively perforating corresponding positions of the contact and the connecting point on the top insulating layer to expose the contact and the connecting point, arranging positioning holes at the positions of the substrate insulating layer and the top insulating layer, which are positioned on the positioning implantation ring, and connecting the connecting point and a connecting contact point sheet.
7. The preparation method according to claim 6, wherein the preparation method specifically comprises the following steps:
processing a substrate insulating layer shape on a carrier and arranging a sacrificial layer, and spin-coating a flexible high polymer material to form the substrate insulating layer;
(II) processing patterns of the contact, the connecting wire, the connecting point and the positioning implantation ring on the surface of the substrate insulating layer, and processing metal on the patterns to form the contact, the connecting wire, the connecting point and the positioning implantation ring;
(III) spin-coating a flexible high polymer material on the surface of one side, provided with a contact, a connecting wire, a connecting point and a positioning implantation ring, of the substrate insulating layer to form a top insulating layer, coating photoresist to form a pattern to protect the whole electrode structure, and removing the substrate insulating layer and the top insulating layer which are not protected by the photoresist;
(IV) removing the photoresist to expose the contact and the connecting point, coating the connecting wire and the positioning implantation ring by the substrate insulating layer and the top insulating layer, processing the surface of the top insulating layer to form a pattern of a connecting contact sheet, arranging metal on the pattern to form the connecting contact sheet, connecting the connecting point with the connecting contact sheet, scribing and removing the sacrificial layer to obtain the nerve electrical stimulation electrode.
8. The manufacturing method according to claim 7, wherein in the step (I), the processing manner of the shape of the base insulating layer comprises an ultraviolet lithography process and an etching process;
preferably, in the step (i), the processing manner of the sacrificial layer includes magnetron sputtering coating and/or electron beam evaporation;
preferably, in step (i), the spin coating is followed by heating;
preferably, in the step (ii), the processing modes of the contact, the connecting line, the connecting point and the positioning implantation ring pattern comprise an ultraviolet lithography process and a developing process;
preferably, in the step (II), the metal is processed in the form of electron beam evaporation or thermal evaporation;
preferably, in step (iii), the shape processing manner of the top insulating layer includes an ultraviolet lithography process and an etching process.
9. A method of implanting the electrostimulation electrode for a nerve according to any of the claims 1 to 5, characterized in that it comprises:
and determining an implantation position by the positioning hole, and implanting the implantation section of the electrode into a target.
10. The implantation method according to claim 9, wherein said implantation method comprises in particular the steps of:
the auxiliary implant penetrates into the positioning hole, the positioning hole determines the implantation position, the implantation section of the electrode is implanted into the target through the auxiliary implant, and the auxiliary implant is taken out; and covering and attaching the connecting section on one side of the base insulating layer on the outer surface of the switching structure, and connecting the connecting section with the adaptive terminal.
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