CN114699087B

CN114699087B - Nerve electrode structure and implantation method and manufacturing method thereof

Info

Publication number: CN114699087B
Application number: CN202210559274.9A
Authority: CN
Inventors: 方英; 王晋芬; 管寿梁
Original assignee: National Center for Nanosccience and Technology China
Current assignee: National Center for Nanosccience and Technology China
Priority date: 2022-05-23
Filing date: 2022-05-23
Publication date: 2023-01-10
Anticipated expiration: 2042-05-23
Also published as: CN114699087A

Abstract

A nerve electrode structure, an implanting method and a manufacturing method thereof are provided, the nerve electrode structure comprises: a flexible mesh portion and a flexible auxiliary implant portion connected to each other; the grid part comprises grid lines, the grid lines comprise data transmission grid lines, the data transmission grid lines comprise data signal lines and an insulating part, and the insulating part wraps part of the data signal lines; the data signal line includes an electrode site, and the insulating part exposes the electrode site; the auxiliary implantation part comprises a strip-shaped part, a first end of the strip-shaped part in the extending direction of the strip-shaped part is connected with the grid part, and a second end of the strip-shaped part, opposite to the first end of the strip-shaped part, is far away from the grid part.

Description

Nerve electrode structure and implantation method and manufacturing method thereof

Technical Field

The invention relates to a nerve electrode structure and an implantation method and a manufacturing method thereof.

Background

The nerve electrode has the main function of realizing the interconversion between the bioelectric signal with ions as a carrier and the universal electric signal with electrons as a carrier, thereby realizing the recording and the regulation of brain and peripheral nerve signals. Existing neural electrodes include electroencephalogram (EEG) electrodes, cortical (ECoG) electrodes, and implantable electrodes. The implanted nerve electrode can record and regulate the electrical activity of a single neuron in a large range, so the implanted nerve electrode has wide application prospect in the fields of nervous system disease treatment, brain-computer interfaces and the like.

Currently, the most widely used implantable neural electrode is a silicon-based rigid neural electrode. However, the mechanical properties of rigid nerve electrodes do not match with the target tissue, such as the brain, causing major mechanical damage to the brain; meanwhile, due to the self-movement of the brain, the rigid electrode is easy to move slightly in the brain, so that the instability of neural signal recording is caused, the inflammatory reaction of the brain is aggravated, and glial cells are generated around the electrode and coated on the surface of an electrode site, so that the attenuation of an electric signal and the failure of the electrode site are caused. Therefore, it is difficult for the rigid electrode to ensure long-term stability of signal recording. Compared with a rigid nerve electrode, the mechanical property of the flexible nerve electrode is matched with that of a target tissue, so that the relative movement with the target tissue and the inflammatory reaction of the target tissue are greatly reduced, and the long-term stable recording and regulation of nerve signals are realized.

Disclosure of Invention

The present invention provides a nerve electrode structure, including: a flexible mesh portion and a flexible auxiliary implant portion connected to each other; the grid part comprises grid lines, the grid lines comprise data transmission grid lines, the data transmission grid lines comprise data signal lines and an insulating part, and the insulating part wraps part of the data signal lines; the data signal line includes an electrode site, and the insulating part exposes the electrode site; the auxiliary implantation part includes a bar-shaped part, a first end of the bar-shaped part in an extending direction thereof is connected with the mesh part, and a second end of the bar-shaped part opposite to the first end thereof is distant from the mesh part.

For example, the present invention provides a neural electrode structure, wherein the neural electrode structure has a first state and a second state; in the first state, the nerve electrode structure is in a sheet shape; in the second state, the grid portion of the neural electrode structure is columnar, and the electrode sites are located on the outer surface of the columnar grid portion; the sheet-like neural electrode structure in the first state is transformed to the second state by being curled about an axis extending in an axial direction.

For example, the present invention provides a neural electrode structure, wherein the flexible grid lines include a plurality of first grid lines and a plurality of second grid lines; in the first state, the first grid lines extend along a first direction, the second grid lines extend along a second direction, the first direction intersects with the second direction, the axial direction is coplanar with the first direction and the second direction, and the first direction is the same as or different from the axial direction; the first end of the bar-shaped portion is connected with the first grid line or the second grid line.

For example, the present invention provides a neural electrode structure in which the auxiliary implanting portion includes a plurality of the bar-shaped portions; in the first state, the grid part is sheet-shaped, and the strip-shaped parts are arranged at intervals in a transverse direction perpendicular to the axial direction and extend along the axial direction; in the second state, the mesh portion is substantially cylindrical and the second ends of the plurality of bars converge such that the plurality of bars form a pyramidal structure.

For example, the present invention provides a nerve electrode structure in which the second end of at least one of the plurality of strips is provided with an auxiliary implant member configured such that a rigid auxiliary implant member can be connected to an auxiliary implant portion of the nerve electrode structure through the auxiliary implant member.

For example, the present invention provides a neural electrode structure, wherein each of the plurality of bar-shaped portions is connected to one of the first grid lines; the plurality of strip-shaped parts are connected with the plurality of first grid lines in a one-to-one correspondence manner, or the number of the plurality of strip-shaped parts is smaller than that of the first grid lines.

For example, the present invention provides the neural electrode structure, wherein the second end of each of the plurality of strip-shaped portions is a tip protruding in a direction away from the mesh portion.

For example, in the neural electrode structure provided by the invention, the number of the strip-shaped parts is 1; in the first state, the grid part is sheet-shaped, and the strip-shaped part extends along the axial direction; in the second state, the mesh portion is substantially cylindrical and the strip portion extends substantially in the first direction.

For example, the present invention provides a nerve electrode structure in which the second end of the bar-shaped portion is provided with an auxiliary implant member configured such that a rigid auxiliary implant member can be connected to the nerve electrode structure through the auxiliary implant member.

For example, the present invention provides a neural electrode structure in which the bar-shaped portion includes a first bar-shaped portion and a second bar-shaped portion; the first strip-shaped portion has a first end and a second end opposite to each other in an extending direction thereof, and the second strip-shaped portion has a first end and a second end opposite to each other in the extending direction thereof; the first end of the first strip-shaped part is connected with the grid lines, the first end of the second strip-shaped part is connected with the grid lines, and the second end of the first strip-shaped part is connected with the second end of the second strip-shaped part; in the first state, the mesh part is sheet-shaped, the first bar-shaped part extends along a third direction, and the third direction is coplanar with and intersects with the first direction and the second direction; the second bar portion extends along a fourth direction that is coplanar with and intersects the first direction, the second direction, and the third direction; in the second state, the mesh portion is substantially cylindrical, and the first strip portion and the second strip portion form a cone structure.

For example, the present invention provides a neural electrode structure, wherein the plurality of first grid lines include first edge grid lines and second edge grid lines; in the first state, the first edge grid lines and the second edge grid lines are respectively first grid lines located outermost in the second direction and are opposed to each other; in the second state, the first edge grid lines and the second edge grid lines are involuted with each other or have a certain distance therebetween; the first end of the first strip-shaped part is connected with the first edge grid line, and the first end of the second strip-shaped part is connected with the second edge grid line.

For example, the present invention provides a nerve electrode structure, wherein a connection portion at which the second end of the first strip-shaped portion and the second end of the second strip-shaped portion are connected is a tip protruding in a direction away from the mesh portion, and the connection portion is provided with an auxiliary implant component configured such that a rigid auxiliary implant member can be connected to the auxiliary implant portion of the nerve electrode structure through the auxiliary implant component.

For example, the present invention provides a neural electrode structure in which the bar-shaped portion further includes a third bar-shaped portion having a first end and a second end opposite to each other in the axial direction, the first end of the third bar-shaped portion being connected to the grid line; the third strip-shaped part is also connected with the second end of the first strip-shaped part and the second end of the second strip-shaped part; in the first state, the grid part is sheet-shaped, and the third strip-shaped part extends along the axial direction; in the second state, the mesh portion is substantially cylindrical, and the first, second and third bars form a cone structure.

For example, the present invention provides a neural electrode structure, wherein the second end of the third bar-shaped part protrudes beyond the second ends of the first bar-shaped part and the second bar-shaped part in the direction away from the grid part in the axial direction, and the second end of the third bar-shaped part is provided with an auxiliary implantation part configured such that a rigid auxiliary implantation member can be connected with the auxiliary implantation part of the neural electrode structure through the auxiliary implantation part.

For example, the present invention provides the neural electrode structure, wherein the bar-shaped portion includes a plurality of fourth bar-shaped portions, each of the plurality of fourth bar-shaped portions having a first end and a second end opposite to each other in the axial direction, the first end of each of the plurality of fourth bar-shaped portions being connected to the grid lines; a first part of the fourth bar-shaped parts is connected with the first bar-shaped part at the second end, and a second part of the fourth bar-shaped parts is connected with the second bar-shaped part at the second end; in the first state, the mesh part is sheet-shaped, and the plurality of fourth strip-shaped parts are arranged at intervals in a transverse direction perpendicular to the axial direction and extend in the axial direction; in the second state, the mesh portion is substantially cylindrical, and the plurality of fourth bars, the first bars, and the second bars form a pyramidal structure.

For example, the present invention provides a neural electrode structure, wherein the auxiliary implantation member is an implantation hole penetrating through the bar-shaped portion; or the auxiliary implanting component is a groove recessed from the surface of the strip-shaped part; alternatively, the auxiliary implanting part is a protrusion protruding from a surface of the bar-shaped portion.

For example, the present invention provides a neural electrode structure, wherein the first grid lines or the second grid lines further include reference grid lines, the reference grid lines include reference signal lines and reference insulation parts, and the reference insulation parts wrap part of the reference signal lines; the reference signal line includes a reference electrode site, and the reference insulation exposes the reference electrode site; in the second state, the reference electrode site is located on an outer surface of the columnar lattice section.

For example, the present invention provides a neural electrode structure in which the mesh portion includes a plurality of layers of the data transmission mesh lines arranged in a stacked manner, and the electrode sites of the data transmission mesh lines located in the different layers are staggered from each other; alternatively, the mesh portion includes a plurality of layers of the mesh lines arranged in a stack, and the electrode sites of the mesh lines located in the different layers are staggered from each other.

For example, the present invention provides a neural electrode structure, wherein at least a part of the plurality of first grid lines is the data transmission grid lines, and/or at least a part of the plurality of second grid lines is the data transmission grid lines.

For example, the present invention provides a neural electrode structure in which the mesh portion has a first end and a second end opposite to each other in the axial direction; the electrode sites are located at first ends of the data signal lines, and second ends of the data signal lines, different from the first ends thereof, are drawn out from first ends of the mesh portions to be connected to a data processing circuit; the first end of the auxiliary implant portion is connected to the second end of the mesh portion.

The invention provides an implantation method of a nerve electrode structure, which comprises the following steps: the strip-shaped part of the auxiliary implantation part is implanted into target tissue, so that the grid part is implanted into the target tissue under the driving of the auxiliary implantation part.

For example, the invention provides a method for implanting a neural electrode structure, comprising: covering a surface of the neural electrode structure with an auxiliary implant substance in a liquid state to cause self-assembly of the neural electrode structure such that the neural electrode structure transitions from the first state to the second state; and implanting the auxiliary implant portion into the target tissue, the mesh portion in the second state being implanted into the target tissue with the auxiliary implant portion, wherein the auxiliary implant substance dissolves and/or disintegrates to uncover the electrode sites.

For example, the present invention provides a method of implanting a neural electrode structure, in a case where the second end of the bar-shaped portion has an auxiliary implantation member, the method including: connecting a first end of a rigid auxiliary implant member with an auxiliary implant portion of the nerve electrode structure through the auxiliary implant component; inserting a first end of the rigid auxiliary implant member into the target tissue and then sequentially implanting the auxiliary implant portion and the mesh portion into the target tissue; and extracting the rigid auxiliary implant member from the rigid auxiliary implant member, the nerve electrode structure remaining in the target tissue.

The invention provides a manufacturing method of a nerve electrode structure, which comprises the following steps: forming a flexible mesh portion and a flexible auxiliary implant portion connected to each other; forming the mesh portion includes: forming flexible grid lines, wherein the grid lines comprise data transmission grid lines, the data transmission grid lines comprise data signal lines and an insulating part, and the insulating part wraps part of the data signal lines; the data signal line includes an electrode site, and the insulating part exposes the electrode site; forming the auxiliary implant portion includes: forming a bar-shaped portion, a first end of the bar-shaped portion in an extending direction thereof being connected with the mesh portion, and a second end of the bar-shaped portion opposite to the first end thereof being distant from the mesh portion.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings of the embodiments will be briefly described below, and it is apparent that the drawings in the following description only relate to some embodiments of the present invention and are not limiting on the present invention.

FIG. 1A is a schematic diagram of a neural electrode structure in a first state according to an embodiment of the present invention;

FIG. 1B is a schematic diagram of another example of a neural electrode structure in a first state, according to an embodiment of the present invention;

FIG. 2A is a schematic plan view of a neural electrode structure connected to an external circuit according to an embodiment of the present invention;

FIG. 2B is an exploded view of a neural electrode structure according to an embodiment of the present invention;

FIGS. 3A-3C are schematic illustrations of an implantation method for implanting the neural electrode structure of FIG. 1A into a target tissue, and FIG. 3A is a schematic illustration of the neural electrode structure of FIG. 1A in a second state;

FIGS. 4A-4D are schematic illustrations of an alternative method of implanting the neural electrode structure of FIG. 1A into a target tissue;

FIG. 5A is a schematic diagram of another example of a neural electrode structure in a first state, according to an embodiment of the present invention;

FIGS. 5B-5D are schematic illustrations of an implantation method for implanting the neural electrode structure of FIG. 5A into a target tissue, and FIG. 5B is a schematic illustration of the neural electrode structure of FIG. 5A in a second state;

FIGS. 6A-6D are schematic illustrations of an alternative method of implanting the neural electrode structure of FIG. 5A into target tissue;

FIG. 7 is a schematic diagram of another example of a neural electrode structure in a first state according to an embodiment of the present invention;

FIG. 8A is a schematic diagram of another example of a neural electrode structure in a first state, according to an embodiment of the present invention;

FIG. 8B is a schematic illustration of the implantation of the neural electrode structure of FIG. 8A using an implantation method combining self-assembly with a rigid auxiliary implant member;

FIGS. 8C-8E are schematic illustrations of implantation of the neural electrode structure of FIG. 8A using an implantation method that employs a rigid auxiliary implantation member to assist in implantation;

FIG. 8F is a schematic view of another example of a neural electrode structure in a first state, according to an embodiment of the present invention;

FIG. 9A is a schematic diagram of another example of a neural electrode structure in a first state, according to an embodiment of the present invention;

FIG. 9B is a schematic diagram of the neural electrode structure shown in FIG. 9A in a second state;

FIG. 10A is a schematic diagram of another example of a neural electrode structure in a first state, according to an embodiment of the present invention;

FIG. 10B is a schematic diagram of the neural electrode structure shown in FIG. 10A in a second state;

FIG. 10C is a schematic illustration of implantation of the neural electrode structure of FIG. 10A using an implantation method combining self-assembly with a rigid auxiliary implant member;

FIG. 11A is a schematic diagram of another example of a neural electrode structure in a first state, according to an embodiment of the present invention;

FIG. 11B is a schematic diagram of the neural electrode structure shown in FIG. 11A in a second state;

FIG. 12A is a flow chart of a method for implanting a neural electrode structure provided in accordance with one embodiment of the present invention;

FIG. 12B is a flow chart of another method for implanting a neural electrode structure provided in accordance with an embodiment of the present invention;

FIG. 13A is a schematic flow chart of a method of fabricating a flexible neural electrode structure, in accordance with an embodiment of the present invention;

fig. 13B is a schematic cross-sectional view of steps in a method of fabricating a flexible neural electrode structure, in accordance with an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the drawings of the embodiments of the present invention. It is to be understood that the embodiments described are only a few embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the invention without any inventive step, are within the scope of protection of the invention.

Unless defined otherwise, technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs. The use of "first," "second," and similar terms in the description and claims of the present application do not denote any order, quantity, or importance, but rather the terms are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items. "inner", "outer", "upper", "lower", and the like are used merely to indicate relative positional relationships, and when the absolute position of the object being described is changed, the relative positional relationships may also be changed accordingly.

The drawings in the invention are not drawn strictly to actual scale, the number of structures such as data transmission grid lines, data signal lines, electrode sites and the like in the neural electrode structure is not limited to the number shown in the drawings, and the specific size and the number of each structure can be determined according to actual needs. The drawings described in this disclosure are for illustrative purposes only.

The implantable nerve electrode is a source for acquiring a nerve electrical signal in a brain-computer interface, and is required to have the characteristics of small implantation injury, excellent biocompatibility, long-term stability and the like because the implantable nerve electrode is in direct contact with target tissues such as the brain. In order to insert the implanted nerve electrode into brain tissue, the conventional implanted nerve electrode is mostly a rigid nerve electrode, such as a silicon needle electrode, a kosher electrode, a metal microwire electrode and the like, and the mechanical properties of the rigid nerve electrode and the soft brain tissue are not matched, so that micro-movement is easy to occur to cause long-term immune reaction of the brain, and finally, the failure of the electrode is caused. The flexible nerve electrode has mechanical performance matched with brain tissue, small immunoreaction and can be used for long-term stable measurement of nerve electrical signals. However, the flexible nerve electrode has a small young's modulus, and is easily bent and deformed when being implanted into brain tissue, and thus needs to be assisted by a rigid material to be implanted into the brain. In recent years, various flexible nerve electrodes and matched implantation methods are developed, including flexible grid electrodes capable of being injected by a needle tube, flexible nerve fringe electrodes assembled by soluble polymers, flexible wire electrodes for assisting in implantation of tungsten wires and the like. However, each flexible electrode adopts a single implantation method, and cannot meet the implantation requirements of multiple modes.

At least one embodiment of the present invention provides a neural electrode structure including: a flexible mesh portion and a flexible auxiliary implant portion connected to each other; the grid part comprises grid lines, the grid lines comprise data transmission grid lines, the data transmission grid lines comprise data signal lines and an insulating part, and the insulating part wraps part of the data signal lines; the data signal line includes an electrode site, and the insulating part exposes the electrode site; the auxiliary implantation part includes a bar-shaped part, a first end of the bar-shaped part in an extending direction thereof is connected with the mesh part, and a second end of the bar-shaped part opposite to the first end thereof is distant from the mesh part.

At least one embodiment of the present invention provides an implanting method of a neural electrode structure, the implanting method including: the strip-shaped part of the auxiliary implantation part is implanted into target tissue, so that the grid part is implanted into the target tissue under the driving of the auxiliary implantation part.

At least one embodiment of the present invention provides a method for manufacturing a neural electrode structure, including: forming a flexible mesh portion and a flexible auxiliary implant portion connected to each other; forming the mesh portion includes: forming flexible grid lines, wherein the grid lines comprise data transmission grid lines, the data transmission grid lines comprise data signal lines and an insulating part, and the insulating part wraps part of the data signal lines; the data signal line includes an electrode site, and the insulating part exposes the electrode site; forming the auxiliary implant portion includes: forming a bar-shaped portion, a first end of the bar-shaped portion in an extending direction thereof being connected with the mesh portion, and a second end of the bar-shaped portion opposite to the first end thereof being distant from the mesh portion.

Exemplarily, fig. 1A is a schematic diagram of a neural electrode structure in a first state according to an embodiment of the present invention. As shown in fig. 1A, the neural electrode structure 100 includes: a flexible mesh part 1 and a flexible auxiliary implant part 2 connected to each other. The grid part 1 comprises grid lines 10, the grid lines 10 comprise data transmission grid lines, the data transmission grid lines comprise data signal lines 11 and insulating parts 13, and the insulating parts 13 wrap part of the data signal lines 11; the data signal line 11 includes an electrode site 12, and the insulating portion 13 exposes the electrode site 12; the auxiliary implanting portion 2 includes a strip portion, for example, the auxiliary implanting portion 2 includes a plurality of strip portions 21a/21b/21c/21d/21e. A first end of each strip in its extending direction is connected to the mesh part 1, and a second end of each strip opposite to its first end is distant from the mesh part 1. The neural electrode structure 100 may be used to implant a target tissue, such as an electrically active tissue, for example, a brain tissue of a human or animal. After the flexible nerve electrode is implanted into a target tissue, the electrode site 12 collects biological information in the target tissue, and the biological information is transmitted to an external circuit through a data signal line 11 where the electrode site 12 is located; and/or, after implanting the flexible neural electrode into the target tissue, the external circuit applies electrical modulation information, which is transmitted to the electrode site 12 of the data signal line 11 via the data signal line 11, the electrode site 12 applying the electrical modulation information to the target tissue. For example, the biological information is an electrical signal.

The electrode site 12 of the nerve electrode structure 100 is located in the mesh part 1, and the second end of the strip part of the auxiliary implantation part 2, which is far away from the mesh part 1, may be implanted into the target tissue first, so that the first end of the strip part, which is connected to the mesh part 1, and the mesh part 1 are implanted into the target tissue in sequence. The nerve electrode structure 100 may be implanted into a target tissue using a variety of implantation methods. For example, the nerve electrode structure 100 is implanted into the target tissue by a self-assembly implantation method, that is, the nerve electrode structure 100 is covered with a liquid auxiliary implant substance (e.g., a molten auxiliary implant substance) so that the nerve electrode structure 100 is self-curled into a columnar shape under the action of the surface tension of the liquid auxiliary implant substance (e.g., the molten auxiliary implant substance), and then the nerve electrode structure 100 is implanted into the target tissue, the structure formed by the mesh part 1 and the bar parts has a better rigidity after being self-curled into the columnar shape, the bar parts with the better rigidity can be easily penetrated into the target tissue, and the mesh part 1 has a very good structural stability, which is beneficial for maintaining the stability of the data signal line 11 including the electrode site 12 during the implantation of the nerve electrode structure 100 into the target tissue; after the columnar nerve electrode structure 100 with high rigidity is implanted into the target tissue, the auxiliary implant substance is dissolved or metabolized, and the nerve electrode structure 100 is gradually restored to a flexible structure. Alternatively, the nerve electrode structure 100 may be implanted into a target tissue by an implantation method combining self-assembly and a rigid auxiliary implantation member, that is, the nerve electrode structure 100 may also be assembled on the surface of the rigid auxiliary implantation member in a liquid auxiliary implantation substance, the assembled nerve electrode structure 100 and the rigid auxiliary implantation member form a columnar whole, and then the assembled whole is implanted into the target tissue, due to the assistance of the rigid auxiliary implantation member, the rigidity of the nerve electrode structure 100 is enhanced, the nerve electrode structure 100 may be implanted into a deeper target tissue, after the auxiliary implant is dissolved or metabolized, the rigid auxiliary implantation member is taken out, and the nerve electrode structure 100 will slowly return to a flexible structure. Therefore, the nerve electrode structure 100 can meet the requirements of different implantation modes, the implantation modes are more flexible, the requirement of target tissues on the flexibility of the nerve electrode structure implanted into the target tissues can be met, and the requirement of the implantation process on the rigidity of the nerve electrode structure can be favorably met. The flexible neural electrode structure 100 which can be implanted by using various methods can match different implanted target tissues and signal acquisition requirements, meet the requirements of materials, depths and the like of various different target tissues, and provide a more convenient neural signal detection and regulation method for brain science research and neural disease research.

As shown in fig. 1A, for example, one data signal line 11 has one electrode site 12, and one data transmission grid line includes a plurality of data signal lines 11. For example, the electrode site 12 is located at the first end of the data signal line 11 to facilitate space rationality of the structure, save space to reduce the volume of the neural electrode structure in the case where the same number of data signal lines 11 and electrode sites 12 are provided, to reduce damage to the target tissue, and facilitate fabrication. Alternatively, in other embodiments, one data signal line 11 (e.g., a metal line) includes multiple electrode sites 12 to transmit more biological information between the outside of the target tissue and the target tissue using the same volume space. The specific arrangement position of the electrode site 12 on the grid line is not limited in the embodiment of the present invention, and those skilled in the art can design the electrode site according to actual needs.

The neural electrode structure 100 has a first state as shown in fig. 1A and a second state as shown in fig. 3A. FIG. 3A is a schematic diagram of the neural electrode structure shown in FIG. 1A in a second state. As shown in fig. 1A, in a first state, the neural electrode structure 100 is in the form of a sheet; for example, the electrode sites 12 may be exposed at the space regions BR defined by the grid lines, or, in other embodiments, the electrode sites 12 may be exposed at the surfaces of the grid lines. As shown in fig. 3A, in the second state, the mesh portion 1 of the neural electrode structure 100 is in the shape of a cylinder, and the electrode sites 12 are exposed for contacting the target tissue. For example, the electrode site 12 is located on the outer surface of the columnar lattice section 1, but of course, the electrode site 12 may be located on the inner surface of the columnar lattice section 1 as long as the electrode site 12 is exposed to contact the target tissue. In the first state, the sheet-like neural electrode structure 100 is transformed to the second state by being curled around the axis extending in the axial direction. For example, the axial direction is the same as the first direction D1 shown in fig. 1A and 3A. Of course, in other embodiments, the axial direction may not be the same as the first direction D1.

For example, in the embodiment shown in FIGS. 1A and 3A, the auxiliary implanting portion 2 includes a plurality of bar portions 21A/21b/21c/21d/21e. For example, the flexible grid lines 10 include a plurality of first grid lines 101 and a plurality of second grid lines 102. As shown in fig. 1A, in the first state, the plurality of first grid lines 101 extend along a first direction D1, the plurality of second grid lines 102 extend along a second direction D2, the first direction D1 intersects the second direction D2, and the axial direction is coplanar with the first direction D1 and the second direction D2; the first end of each bar portion 21a/21b/21c/21d/21e is connected to the first grid lines 101 or/and the second grid lines 102. In the first state, the mesh portion 1 is sheet-shaped, and the plurality of strip portions 21a/21b/21c/21D/21e are arranged at intervals from each other in a lateral direction (in the present embodiment, the axial direction is the second direction D2) perpendicular to the axial direction (in the present embodiment, the axial direction is the first direction D1) and each extend in the axial direction; as shown in fig. 3A, in the second state, the mesh portion 1 has a substantially cylindrical shape, and the second ends of the plurality of bar-shaped portions 21a/21b/21c/21d/21e are collected so that the plurality of bar-shaped portions 21a/21b/21c/21d/21e form a cone structure having a vertex 20 as a fixed point, which is capable of reducing the resistance to penetration into the target tissue.

Here, the cylindrical shape is not necessarily a regular cylindrical shape, but a quasi-cylindrical shape is also possible, and the entire shape may be a columnar shape like a cylindrical shape.

For example, the number of the second grid lines 102 and the number of the blank areas BR defined by the second grid lines 102 and the first grid lines 101 are not limited in the embodiment of the present invention. As shown in fig. 1A, the plurality of empty cells BR defined by the second grid lines 102 and the first grid lines 101 have substantially the same size and are arranged in an array, so as to improve the uniformity of the structure of the neural electrode, and facilitate obtaining a relatively uniform data acquisition or data transmission effect in a target position region in a target tissue. For example, in one vacant region BR, one electrode site 12 is provided. But is not limited to the situation shown in fig. 1A.

For example, as shown in fig. 1B, in a neural electrode structure 100 provided by another embodiment of the present invention, the size of a plurality of empty lattice regions BR defined by the second lattice lines 102 and the first lattice lines 101 intersecting each other is not completely equal; for a plurality of blank regions BR provided with

electrode sites

12, 1 or more electrode sites 12 may be provided in 1 blank region BR. For example, in a part of the blank space regions BR,1 electrode site 12 is provided in 1 blank space region BR; in another partial blank region BR, 2 electrode sites 12 are provided in 1 blank region BR. Of course, the number of the electrode sites disposed in the 1 space region BR is not limited to 1 or 2, and may also be more than 2, which is not limited in the embodiment of the present invention. Other features and corresponding technical effects of fig. 1B are the same as those of fig. 1A, and reference may be made to the description of fig. 1A.

For example, fig. 3A-3C are schematic illustrations of an implantation method for implanting the neural electrode structure 100 of fig. 1A into a target tissue. The neural electrode structure shown in fig. 1A can be implanted into a target tissue by a self-assembly method. With reference to fig. 1A and fig. 3A-3C, the surface of the neural electrode structure 100 shown in fig. 1A is covered with an auxiliary implant substance to allow self-assembly of the neural electrode structure 100, so that the neural electrode structure is transformed from the first state shown in fig. 1A to the second state shown in fig. 3A; then, as shown in fig. 3B-3C, the auxiliary implantation portion 2 is implanted into the target tissue 5 first, for example, the apex 20 of the cone-shaped structure contacts the surface of the target tissue 5 first, the apex 20 of the cone-shaped structure penetrates into the target tissue 5 first, the cone-shaped structure can reduce the resistance to penetration into the tissue, at least a part of the mesh portion 1 in the second state is implanted into the target tissue 5 under the driving of the auxiliary implantation portion 2, and the number of the electrode sites 12 implanted into the target tissue 5 can be determined as required, thereby determining the depth of implantation into the target tissue 5; after the mesh portion 1 is implanted into the target tissue 5, the implant-assisting substance dissolves and/or disintegrates to uncover the electrode sites 12, thereby allowing the electrode sites 12 to contact the target tissue 5 to collect biological information in the target tissue, or to transmit biological information from the external environment to the target tissue. Namely, the strip-shaped part of the auxiliary implantation part is implanted into the target tissue, so that the grid part is implanted into the target tissue under the driving of the auxiliary implantation part.

For example, during the process of implanting the neural electrode structure 100 by using the self-assembly method, at least a part of the mesh part 1 of the implantable flexible neural electrode structure 100 shown in fig. 1A, for example, a part including the electrode sites 12, and the auxiliary implantation part 2 are put into a solution of an auxiliary implantation substance and then taken out, and the implantable flexible neural electrode structure 100 is self-assembled under the surface tension of the auxiliary implantation substance to be converted from the first state shown in fig. 1A to the second state shown in fig. 3A.

For example, the auxiliary implant substance includes one or more of a thermally fusible material and a liquid dissolvable material. For example, when the temperature of the target tissue is such that the auxiliary implant substance dissolves in the tissue fluid, the potential pole 12 is exposed; alternatively, the auxiliary implant substance may dissolve in the tissue fluid itself to expose the potential pole 12; alternatively, the auxiliary implant material decomposes in the interstitial fluid to expose the potential pole 12.

After dissolution or dissolution of the auxiliary implant substance, the neural electrode structure 100 in the second state in fig. 3C returns to the flexible state. The mechanical properties of the flexible neural electrode structure according to the embodiment of the invention are matched with those of the target tissue 5 (for example, brain tissue), so that the inflammatory response of the target tissue 5 is not caused, and the target tissue 5 can be monitored and/or regulated in a multi-point and long-term stable manner.

For example, the thermally fusible material includes a thermally fusible polymer, such as a thermally fusible polymer in a molten state or a solution of a thermally fusible polymer. Examples of the thermally fusible polymer include one or more of polyethylene glycol (PEG) and Polylactic-co-glycolic acid (PLGA).

For example, the liquid dissolving material includes a water-soluble polymer, such as one or more of polyvinyl alcohol (PVA), fibroin, polyethylene glycol (PEG), polylactic-co-glycolic acid-polyethylene glycol (PLGA-PEG), and gelatin; the liquid comprises one or more of ultrapure water, physiological saline and Phosphate (PBS) buffer. When the PVA solution is selected, the concentration of the PVA solution is 2% -10%, such as 2%, 5%, 10%, and the like, such as 5%.

For example, as shown in FIG. 1A, each of the plurality of bar-shaped portions 21A/21b/21c/21d/21e is connected to one first grid line 101; the plurality of bar-shaped portions 21a/21b/21c/21d/21e are connected to the plurality of first grid lines 101 in a one-to-one correspondence, so that the strength of the auxiliary implantation portion 2 can be enhanced during the implantation of the neural electrode structure 100 by the self-assembly method, thereby facilitating the reduction of the resistance from the target tissue. For example, in the present embodiment, in the first state, each strip-shaped portion is located on an extension line of a corresponding one of the first grid lines 101, so as to form a regular cylinder structure and a cone-shaped structure in the second state, thereby more smoothly implanting the neural electrode structure into a target tissue, and reducing the difficulty in manufacturing the neural electrode structure.

For example, as shown in FIG. 1A, the second ends of the plurality of strips 21A/21b/21c/21d/21E are pointed ends E1/E2/E3/E4/E5, respectively, protruding away from the mesh portion 1, so as to facilitate reducing the resistance from the target tissue 5 to the second ends of the strips during implantation.

For example, according to an embodiment of the present invention, the flexible insulating part 13 wraps the data signal line 11 may be understood that the flexible insulating part 13 covers all surfaces of the data signal line 11 except for the electrode site 12 and surfaces in contact with other components.

For example, according to the embodiment of the present invention, the flexible insulating portion 13 is made of a flexible material having good biocompatibility and mechanical elasticity. Further, for example, the material of the flexible insulating portion 13 includes at least one of Polyimide (PI), parylene (Parylene C), and SU-8 photoresist. For example, the material of the flexible insulating portion 13 includes a combination of SU-8 photoresist and Parylene C, a combination of Parylene C and PI, or a combination of SU-8 photoresist, parylene C and PI, or the like; more preferably, the material of the flexible insulating portion 13 is PI. For example, the flexible insulation 13 is transparent or translucent or opaque.

For example, the data signal line 11 includes a wire electrode and an electrode site 12 electrically connected to the wire electrode. The wire electrode, i.e. the trace portion of the data signal line 11, for example, in the embodiment shown in fig. 1, the electrode site 12 is located at the end of the wire electrode; alternatively, in other embodiments, the electrode sites may be located at other positions of the wire electrode than at the ends. For example, according to an embodiment of the present invention, the wire electrode and the electrode site 12 electrically connected to each other are formed of the same material or formed of different materials, which is not limited by the embodiment of the present invention. For example, in order to simplify the manufacturing process, the wire electrode and the electrode site 12 electrically connected to each other are formed of the same material. For example, according to an embodiment of the present invention, the material of the electrode wire and the electrode site 12 includes at least one of gold, platinum, and iridium. For example, the material of the wire electrode and the electrode site 12 is a combination of gold and platinum, a combination of platinum and iridium, or a combination of gold, platinum and iridium, or the like; it is further preferred that the material of the wire electrode and the electrode site 12 is gold. It should be noted that "the material of the wire electrode and the electrode site 12 includes at least one of gold, platinum, and iridium" means that the material of at least the outer surface of the wire electrode and the electrode site 12 includes at least one of gold, platinum, and iridium.

For example, as shown in fig. 1A, according to an embodiment of the present invention, the planar shape (orthographic shape) of the electrode site 12 is a semicircle, a major circle, a minor circle, an ellipse or a circle, an irregular shape, or the like; more preferably circular, for example, having a diameter of 1 μm to 100. Mu.m, for example, 1 μm, 5 μm, 10 μm, 30 μm, 50 μm, 70 μm, 100 μm, or the like; more preferably 20 μm.

For example, as shown in fig. 1A and 3A, the electrode site 12 is located on the wire electrode, i.e., it is part of the wire electrode; in this case, a portion of the wire electrode is exposed from the flexible insulating portion 13 to serve as the electrode site 12. For example, the electrode site may also be located outside the wire electrode, which is electrically connected to the wire electrode by a connection structure. For example, according to an embodiment of the present invention, the arrangement of the electrode sites is not particularly limited as long as the electrode sites and the wire electrodes are electrically connected.

For example, according to an embodiment of the invention, the thickness of the flexible insulation 13 is 0.1 μm to 200 μm, e.g. 0.1 μm, 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 7 μm, 10 μm, 13 μm, 15 μm, 17 μm, 20 μm or 50 μm, etc.; more preferably 2 μm. Thickness of the flexible insulating portion 13 referring to fig. 13B, the thickness of the insulating portion 13 in a direction perpendicular to the surface of the substrate 1000 for carrying the insulating portion 13 and the data signal line 11.

For example, according to an embodiment of the present invention, the thickness of the data signal line 11 is 10 nm to 1000 nm, for example, 10 nm, 50 nm, 100 nm, 300 nm, 500 nm, 800 nm, 1000 nm, or the like; more preferably 100 nm. Thickness of the data signal line 11 refer to a thickness h of the data signal line 11 in a direction perpendicular to the surface of the substrate 1000 for carrying the insulating portion 13 and the data signal line 11 in fig. 13B.

For example, according to an embodiment of the present invention, the width of the data signal line 11 is 0.01 μm to 200 μm, such as 0.01 μm, 0.1 μm, 1 μm, 5 μm, 10 μm, 50 μm, 100 μm, or 200 μm, etc.; more preferably 20 μm. The width of the data signal line 11 is its line width, see the width w of the data signal line 11 in the direction parallel to the surface of the substrate 1000 for carrying the insulating portion 13 and the data signal line 11 and perpendicular to the extending direction thereof in fig. 13B.

For example, as shown in fig. 1A, the first grid lines 101 or the second grid lines 102 further include reference grid lines, the reference grid lines include reference signal lines 110 and reference insulation 130, and the reference insulation 130 wraps around a portion of the reference signal lines 110; the reference signal line 110 includes a reference electrode site 120, and the reference insulation part 130 exposes the reference electrode site 120; in the second state, the reference electrode site 120 is located, for example, on the outer surface of the columnar mesh portion 1. So long as the reference electrode site 120 is exposed so that it can be brought into contact with the target tissue.

For example, as shown in fig. 1A, the plurality of first grid lines 101 includes first edge grid lines 10a and second edge grid lines 10b; in the first state, the first edge grid lines 10a and the second edge grid lines 10b are the first grid lines 101 located outermost in the second direction D2, respectively, and are opposed to each other. For example, the first edge grid line 10a and the second edge grid line 10b are respectively taken as two reference grid lines, i.e., the leftmost first grid line 101 and the rightmost first grid line 101 in the figure are respectively taken as two reference grid lines. For example, in the second state, the first edge grid lines 10a and the second edge grid lines 10b are aligned with each other, i.e., the first edge grid lines 10a and the second edge grid lines 10b are in contact, e.g., both are completely aligned (in the second direction, the entire length of the first edge grid lines 10a is in contact with the entire length of the second edge grid lines 10 b), or are not completely aligned (a part of the first edge grid lines 10a is in contact with a part of the second edge grid lines 10 b), so as to improve the structural stability and rigidity of the neural electrode structure 100 in the second state, thereby ensuring that the neural electrode structure 100 in the second state is implanted into the target tissue by using the self-assembly method smoothly. Alternatively, in some embodiments, the first edge grid lines 10a and the second edge grid lines 10b have a certain distance therebetween, i.e., the first edge grid lines 10a and the second edge grid lines 10b do not contact, and embodiments of the present invention are not limited to the case where the first edge grid lines 10a and the second edge grid lines 10b are involuted with each other in the second state.

For example, in the first direction D1, the height of the reference electrode site 120 is located within a range distributed with the plurality of electrode sites 12 to better serve as a reference for signals acquired by the electrode sites 12 within the range. For example, the neural electrode structure 100 includes two reference electrode sites, a first reference electrode site 120a and a second reference electrode site 120b. For example, the first and second

reference electrode sites

120a and 120b are connected to an external circuit through the first and second

reference signal lines

110a and 110b, respectively. For example, in the first direction D1, the position of the reference electrode site 120 is located within a range where the plurality of electrode sites 12 are distributed, so as to better serve as a reference for the signals acquired by the electrode sites 12 within the range. For example, the neural electrode structure 100 includes two reference electrode sites, a first reference electrode site 120a and a second reference electrode site 120b, respectively, at one end of the two reference grid lines near the auxiliary implant portion 2.

For example, the line width of the first mesh lines 101 is greater than the line width of the second mesh lines 102, on one hand, so that the first mesh lines 101 have sufficient space to dispose the data signal lines 11 and the reference signal lines 110, and on the other hand, to form a cylindrical structure for the electrodes to have a supporting function in the lateral direction. The reference electrode sites 120 and the electrode sites are arranged on the first grid lines 101, so that the structure of the grid part 1 is more regular and uniform, the manufacturing is convenient, the stability of the grid part 1 is facilitated, and the implantation effect of the neural electrode structure 100 is ensured. For example, in other embodiments, the electrode sites and the reference electrode sites may be disposed on the second grid line, and the position of the reference electrode site 120 is located within the distribution range of the plurality of electrode sites 12 in the second direction D2. The embodiments of the present invention do not limit the specific positions of the electrode site and the reference electrode site.

For example, the mesh portion 1 includes a plurality of layers of data transmission mesh lines arranged in a stack, and electrode sites of the data transmission mesh lines located at different layers are staggered from each other; alternatively, the mesh part 1 includes a plurality of layers of mesh lines 10 arranged in a stack, and the electrode sites 12 of the mesh lines 10 located in different layers are staggered from each other, i.e., orthographic projections of the electrode sites 12 of the mesh lines 10 located in different layers on a plane parallel to the extending direction of the mesh part 1 do not overlap each other. In this way, more electrode sites can be provided using neural electrode structures that occupy the same space, and a greater amount of data can be acquired or transferred using the electrode sites.

For example, at least a portion of the plurality of first gridlines 101 are data transmission gridlines. In the embodiment shown in fig. 1A, each first grid line 101 comprises data signal lines 11, i.e. each first grid line 101 is a data transmission grid line; in another embodiment, the data signal lines 11 may be disposed in a part of the first grid lines 101 and the data signal lines 11 may not be disposed in another part of the first grid lines 101 in the plurality of first grid lines 101. And/or, in some other embodiments, at least a portion of the plurality of second grid lines 102 may also be data transmission grid lines, i.e., the data signal lines 11 may also be disposed within the second grid lines 102 such that the data signal lines 11 also serve as data transmission grid lines.

Fig. 2A is a schematic plan view of a neural electrode structure connected to an external circuit according to an embodiment of the present invention. As shown in fig. 2A, each data signal line 11 is connected to the pad 8, and the pad 8 is connected to the external circuit 9; that is, the data signal line 11 is connected to the external circuit 9 through the pad 8 connected thereto. It should be noted that the dimensions of the portions shown in fig. 1A and 2A are merely exemplary and should not be considered as limiting the embodiments of the present invention.

For example, the mesh portion 1 has a first end and a second end opposite to each other in the axial direction; the electrode site 12 is located at a first end of the data signal line 11, and a second end of the data signal line 11 different from the first end thereof is drawn out from the first end of the mesh portion 1 to be connected to a data processing circuit, i.e., the external circuit 9; the first end of the auxiliary implanting portion 2 is connected with the second end of the mesh portion 1.

Fig. 2B is an exploded view of a neural electrode structure according to an embodiment of the present invention. For example, the insulating part 13 includes a first insulating layer 131 and a second insulating layer 132, and the entire structure of the first insulating layer 131 and the second insulating layer 132 wraps the portions of the data signal line 11 except for the electrode sites 12 and the portions connected to the pads 8. Part (a) of fig. 2B illustrates the first insulating layer 131, part (B) of fig. 2B illustrates the data signal line 11 including the electrode site 12, and the pad 8 connected to the data signal line 11, and part (c) of fig. 2B illustrates the second insulating layer 132. Referring to part (c) of fig. 2B, the second insulating layer 132 includes an opening 20h1 to expose the electrode site 12. Referring to fig. 2B, the second insulating layer 132 includes an opening 20h2 to expose the pad 8.

Fig. 4A-4D are schematic illustrations of another implantation method for implanting the neural electrode structure of fig. 1A into a target tissue, i.e., the neural electrode structure 100 is implanted into the target tissue by an implantation method combining self-assembly with a rigid auxiliary implantation member. As shown in fig. 4A, for example, the nerve electrode structure 100 is assembled on the surface of the rigid auxiliary implantation member 4 in a liquid auxiliary implantation material (e.g., a molten auxiliary implantation material), the nerve electrode structure 100 surrounds the rigid auxiliary implantation member 4 on the outer surface of the rigid auxiliary implantation member 4 by using the rigid auxiliary implantation member 4 as an axis, and the assembled nerve electrode structure 100 and the rigid auxiliary implantation member form a columnar integral structure; for example, the rigid auxiliary implant member 4 and the nerve electrode structure 100 may be immersed together in a solution of the auxiliary implant substance or in a molten auxiliary implant substance, so that the nerve electrode structure 100 self-curls or self-assembles to be more firmly attached to the outer surface of the rigid auxiliary implant member 4 with the rigid auxiliary implant member 4 as an axis; then, the auxiliary implanting portion 2 is first implanted into the target tissue 5. For example, as shown in fig. 4B, the auxiliary implantation portion 2 is implanted into the target tissue 5 first, and then the lattice structure 1 is implanted into the target tissue 5; for example, the first end 41 of the rigid auxiliary implantation member 4 has a tapered shape, and the tapered structure of the auxiliary implantation portion 2 is attached to the first end 41 of the rigid auxiliary implantation member 4, for example, by bringing the apex 20 of the tapered structure (or the apex of the first end 41 of the rigid auxiliary implantation member 4) into contact with the surface of the target tissue 5, and thereby penetrating the apex 20 of the tapered structure (or the apex of the first end 41 of the rigid auxiliary implantation member 4) into the target tissue 5, and thereby implanting the entire assembled columnar structure into the target tissue 5, as shown in fig. 4C. The conical structure reduces the resistance to tissue penetration and, with the aid of the rigid auxiliary implantation member, increases the rigidity of the neural electrode structure, which can be implanted into deeper target tissue, it being noted that the apex 20 of the conical structure may coincide with the apex of the first end 41 of the rigid auxiliary implantation member 4 or may be offset therefrom, and both penetrate into the target tissue 5 substantially simultaneously as a whole. After the neural electrode structure of fig. 4C is implanted into the target tissue 5 and the auxiliary implant is dissolved or metabolized, the rigid auxiliary implant member 4 is removed, and the neural electrode structure will slowly return to a flexible structure as shown in fig. 4D.

For example, the rigid auxiliary implantation member 4 is an array of optical fibers, tungsten wires, platinum-iridium alloy wires, and nichrome wires arranged in three-dimensional space; or an array of silicon needles fabricated with a Micro-Electro-Mechanical System (MEMS); or a comb-shaped array obtained by deep silicon etching; or a needle array obtained by MEMS processing.

FIG. 5A is a schematic diagram of another example of a neural electrode structure in a first state, according to an embodiment of the present invention; FIG. 5B is a schematic diagram of the neural electrode structure shown in FIG. 5A in a second state. The nerve electrode structure 100 shown in fig. 5A has the following differences from the nerve electrode structure 100 shown in fig. 1A.

For example, as shown in fig. 5A, the second end of at least one of the plurality of bar-shaped portions 21a/21b/21c/21d/21e is provided with an auxiliary implant component configured such that the rigid auxiliary implant member 4 can be connected with the auxiliary implant part 2 of the nerve electrode structure 100 through the auxiliary implant component. For example, the auxiliary implant component is an implant hole through the second end of the strip. For example, the second end of each of the plurality of bars 21a/21b/21c/21d/21e is provided with an implantation hole, and the plurality of bars 21a/21b/21c/21d/21e includes implantation holes H1/H2/H3/H4/H5, respectively. Of course, in other embodiments, a portion of the strip may have an auxiliary implant component and a portion of the strip may not have an auxiliary implant component.

For example, the implantation hole may be circular or oval, and the shape of the implantation hole is not limited in the embodiments of the present invention.

For example, the neural electrode structure 100 shown in fig. 5A may be implanted into the target tissue 5 using a self-assembly implantation method, or an implantation method combining self-assembly with a rigid auxiliary implantation member.

Fig. 5B-5D are schematic illustrations of the implantation of the neural electrode structure of fig. 5A into a target tissue using a self-assembly implantation method. The implantation procedure illustrated in fig. 5B-5D may be specifically referred to as described with respect to fig. 3A-3C.

For example, in other embodiments, the auxiliary implant component is a groove recessed from a surface of the bar; alternatively, the auxiliary implant member is a projection projecting from the surface of the bar-shaped portion.

By way of example, in the embodiment shown in fig. 5A, the auxiliary implant component is a through hole, and the rigid auxiliary implant member 4 cooperating with the auxiliary implant component has a projection cooperating with the through hole. However, embodiments of the present invention are not limited thereto, and in the case where the auxiliary implant component is a protrusion, the rigid auxiliary implant member 4, which is fitted with the auxiliary implant component, may have a hole or a groove, which is fitted with the protrusion.

Fig. 6A-6D illustrate the implantation of the neural electrode structure 100 of fig. 5A into a target tissue 5 using a self-assembly combined rigid auxiliary implant member implantation method.

For example, as shown in fig. 6A, the first end 41 of the rigid auxiliary implanting member 4 is tapered, and the first end 41 of the rigid auxiliary implanting member 4 can be connected to the auxiliary implanting portion 2 of the neural electrode structure 100 through an implanting hole H3, for example, the first end 41 of the rigid auxiliary implanting member 4 can be inserted through the implanting hole H3, and the rigid auxiliary implanting member 4 can be inserted through at least one of the plurality of implanting holes H1 to H5, taking the implanting hole H3 as an example; then, the nerve electrode structure 100 is wound around the outer surface of the rigid auxiliary implant member 4 with the rigid auxiliary implant member 4 as an axis; then, the rigid auxiliary implant member 4 and the nerve electrode structure 100 are together immersed in a solution of an auxiliary implant substance to cause the nerve electrode structure 100 to self-curl or self-assemble to more firmly adhere to the outer surface of the rigid auxiliary implant member 4 with the rigid auxiliary implant member 4 as an axis, so that the nerve electrode structure 100 is transformed from the first state shown in fig. 1A to the second state shown in fig. 2A, as shown in fig. 6A; then, as shown in fig. 6B, the auxiliary implanting portion 2 is implanted into the target tissue 5 first. The cone-shaped structure of the auxiliary implantation part 2 is attached to the first end 41 of the rigid auxiliary implantation member 4, for example, the top 20 of the cone-shaped structure (or the top of the first end 41 of the rigid auxiliary implantation member 4) is firstly penetrated into the target tissue 5, the cone-shaped structure can reduce the resistance of penetrating into the tissue, at least part of the mesh part 1 in the second state is implanted into the target tissue 5 under the driving of the auxiliary implantation part 2, the number of the electrode sites 12 implanted into the target tissue 5 can be determined according to the requirement, and the depth of implantation into the target tissue 5 is determined; after the mesh portion 1 is implanted into the target tissue 5, the implant-assisting substance dissolves and/or disintegrates to uncover the electrode sites 12, thereby allowing the electrode sites 12 to contact the target tissue 5 to collect biological information in the target tissue, or to transmit biological information from the external environment to the target tissue. Namely, the strip-shaped part of the auxiliary implantation part is implanted into the target tissue, so that the grid part is implanted into the target tissue under the driving of the auxiliary implantation part. Then, as shown in fig. 6C, the rigid auxiliary implant member 4 is pulled out to separate the rigid auxiliary implant member 4 from the flexible nerve electrode structure 100, leaving the flexible nerve electrode structure 100 in the target tissue. As shown in fig. 6D, after the auxiliary implant substance is dissolved or decomposed, the nerve electrode structure 100 in the second state recovers flexibility and is unfolded to stay in the target tissue 5.

For example, after the soluble polymer is dissolved or decomposed, the rigid auxiliary implant member 4 is pulled out to prevent the neural electrode structure 100 from being pulled out of the target tissue. An implantation method that employs self-assembly in combination with a rigid auxiliary implant member to assist implantation may enhance the rigidity of the neural electrode structure in the second state, facilitating a reduction in resistance to exposure to target tissue.

For example, a rigid secondary implant member 4 is employed having a first end with a tapered tip that further reduces resistance from the target tissue as it penetrates the target tissue.

For example, the neural electrode structure 100 shown in fig. 5A is immersed in a solution of an auxiliary implant substance to cover the surface of the neural electrode structure 100 shown in fig. 5A with the auxiliary implant substance, so that the neural electrode structure 100 undergoes self-curling or self-assembly under the surface tension of the auxiliary implant substance, and the neural electrode structure 100 is transformed from the first state to the second state; then, the first end 41 of the rigid auxiliary implanting member 4 is connected with the auxiliary implanting portion 2 of the nerve electrode structure 100 through the implanting hole H3, for example, one end of the rigid auxiliary implanting member 4 is passed through the implanting hole H3, here taking the implanting hole H3 as an example, the rigid auxiliary implanting member 4 can be passed through at least one of the plurality of implanting holes H1-H5; then, the rigid auxiliary implantation member 4 is inserted into the columnar neural electrode structure 100 so that the neural electrode structure 100 is attached to the outer surface of the rigid auxiliary implantation member 4 with the rigid auxiliary implantation member 4 as an axis; then, the steps described above with reference to fig. 6C-6D are performed to complete the implantation of the neural electrode structure 100.

Additional details of the implantation process shown in fig. 6A-6D may be found in reference to the description of fig. 4A-4D.

Other features and technical effects of the embodiment shown in fig. 5A are the same as those of fig. 1A, and are not repeated here for the same parts.

Fig. 7 is a schematic diagram of another neural electrode structure in a first state according to an embodiment of the present invention. The nerve electrode structure shown in fig. 7 has the following differences from the nerve electrode structure shown in fig. 5A.

As shown in FIG. 7, the number of the plurality of bar portions 21a/21b/21c is smaller than the number of the first grid lines 101. For example, the neural electrode structure shown in fig. 7 has 3 strip-shaped portions, but is not limited to 3, and the specific number of the strip-shaped portions is not limited in the embodiment of the present invention.

For example, in the neural electrode structure 100 shown in fig. 7, for each first grid line 101, the electrode sites 12 are disposed on two sides of the first grid line 101 opposite to each other, that is, the electrode sites 12 are exposed by the insulating part 13 on two sides of the first grid line 101 opposite to each other, so as to acquire biological signals at more positions near the position or transmit external biological signals to more positions, thereby expanding the sensing range.

For example, as shown in fig. 7, the first reference electrode site 120a and the second reference electrode site 120b are respectively located at the ends of the reference grid lines where they are located far away from the auxiliary implantation portion 2.

Other features and technical effects of the embodiment shown in fig. 7 are the same as those of fig. 5A, and the implantation method can also refer to the implantation method for the neural electrode structure shown in fig. 5A. The implantation of the neural electrode structure shown in fig. 7 into the target tissue may be achieved using a self-assembling implantation method, or an implantation method combining self-assembly with a rigid auxiliary implantation member.

Fig. 8A is a schematic view of another nerve electrode structure in a first state according to an embodiment of the present invention, and fig. 8B is a schematic view of the nerve electrode structure shown in fig. 8A implanted by using an implantation method combining self-assembly and a rigid auxiliary implantation member. The nerve electrode structure shown in fig. 8A has the following differences from the nerve electrode structure shown in fig. 5A.

As shown in fig. 8A, the number of the strip portions is 1, that is, the auxiliary implanting portion 2 has only one strip portion 21a. In the first state, the mesh part 1 is sheet-shaped, and the strip-shaped part extends along the axial direction; as shown in fig. 8B, in the second state, the mesh portion 1 has a substantially cylindrical shape, and the strip-shaped portions extend substantially in the first direction D1. The arrangement shown in figure 8A allows the structure of the nerve electrode structure 100 to be simplified and the volume of the auxiliary implant part 2 implanted in the target tissue, for example, electrically active tissue such as the brain of a human or animal, to be minimized, thereby minimizing the effect of the implanted auxiliary implant part on the target tissue while ensuring implantation of an electrode site capable of acquiring or transmitting signals from or to the target tissue, which is important for acquiring or transmitting signals from or to the target tissue without affecting the normal operation of the target tissue. Meanwhile, the neural electrode structure 100 can also be implanted into the target tissue by using various implantation methods, such as a method of using a rigid auxiliary implantation member to assist implantation, a method of combining self-assembly with the rigid auxiliary implantation member to assist implantation, and the like, as shown in fig. 4A. For example, the second end of the strip portion 21a in fig. 8A is also provided with an auxiliary implantation member such as an implantation hole H1, and reference may be made to the foregoing description.

As shown in FIG. 8A, a first reference electrode site 120a is located at an end of the reference grid line where it is located that is closer to auxiliary implant portion 2, and a second reference electrode site 120b is located at an end of the reference grid line where it is located that is farther from auxiliary implant portion 2.

As shown in fig. 8B, the nerve electrode structure 100 shown in fig. 8A can be implanted into the target tissue 5 by an implantation method combining self-assembly with a rigid auxiliary implantation member, and during the implantation process, the nerve electrode structure 100 is self-curled or self-assembled under the action of the surface tension of the auxiliary implantation material and is more firmly attached to the outer surface of the rigid auxiliary implantation member 4 by taking the rigid auxiliary implantation member 4 as an axis, so that the rigidity of the single strip-shaped portion 21a is greatly enhanced, and the resistance to penetration into the target tissue is favorably reduced.

Other features and technical effects of the embodiment shown in fig. 8A are the same as those of fig. 5A, and other steps of the implantation method using self-assembly in combination with a rigid auxiliary implantation member, auxiliary implantation substances used, and the like which are not described herein can also be referred to the description of the implantation method of the neural electrode structure shown in fig. 5A.

For example, the neural electrode structure shown in fig. 8A may also be implanted using an implantation method that uses a rigid auxiliary implantation member to assist in implantation. Figures 8C-8E are schematic illustrations of implantation of the neural electrode structure of figure 8A using a rigid auxiliary implant member to assist in the implantation process. During this implantation process, the nerve electrode structure 100 is always maintained in the first state, without the nerve electrode structure 100 being required to be transformed from the first state to the second state, i.e. the nerve electrode structure 100 does not self-assemble. As shown in fig. 8C, the first end 41 of the rigid auxiliary implantation member 4 is connected with the auxiliary implantation portion 2 of the nerve electrode structure 100 through the implantation hole H1, for example, the first end 41 of the rigid auxiliary implantation member 4 is passed through the implantation hole H1; then, as shown in fig. 8D, the first end of the rigid auxiliary implantation member 4 is inserted into the target tissue 5 and then the auxiliary implantation portion 2 and the mesh portion 1 are sequentially implanted into the target tissue 5; then, as shown in fig. 8E, the rigid auxiliary implant member 4 is pulled out of the rigid auxiliary implant member 4, and the flexible nerve electrode structure 100 remains in the target tissue 5. It should be noted that fig. 8E is only a schematic diagram, the flexible neural electrode structure 100 remaining in the target tissue 5 does not necessarily have the form of the particularly regular and very flat state shown in fig. 8E, and may be in an irregular state, for example, a part of the position of the neural electrode structure is bent, and the like, the neural electrode structure 100 shown in fig. 8A is not only simple in structure and easy to manufacture, and can reduce the influence of the implanted auxiliary implantation part on the target tissue, but also can be applied to the implantation method of fig. 8C to 8E, and is simple and reliable in operation, and does not need to bring additional chemical substances into the target tissue, so as to achieve the effect of reducing the adverse influence on the target tissue as much as possible.

For example, as shown in fig. 8F, in another flexible nerve electrode structure 100 provided in the embodiment shown in fig. 8F, a plurality of auxiliary implant components may be disposed on the strip portion 21a for standby, and as an example, the auxiliary implant components are implantation holes, and a first implantation hole H1, a second implantation hole H2 and a third implantation hole H3 are disposed on the strip portion 21 a; for example, the first, second, and third planting holes H1, H2, and H3 are spaced apart from each other along the first direction D1, which is the extending direction of the bar-shaped portion 21a. In implanting the nerve electrode structure 100 into a target tissue using a rigid auxiliary implant member and an implant hole, a first end of the rigid auxiliary implant member may be inserted into any at least one implant hole of the plurality of implant holes. Of course, the number of the auxiliary implantation parts is not limited to 3 in fig. 8F, and can be designed according to actual needs. Other features and corresponding technical effects of the embodiment shown in fig. 8F are the same as those in fig. 8A, and reference may be made to the previous description, which is not repeated here.

FIG. 9A is a schematic diagram of another example of a neural electrode structure in a first state, according to an embodiment of the present invention; fig. 9B is a schematic diagram of the neural electrode structure shown in fig. 9A in a second state. The neural electrode structure 100 shown in fig. 9A to 9B has the following differences from the neural electrode structure 100 shown in fig. 1A.

As shown in fig. 9A, for example, the bar portion of the auxiliary implanting portion 2 includes a first bar portion 211 and a second bar portion 212; the first bar-shaped portion 211 has first and second ends opposite to each other in an extending direction thereof, and the second bar-shaped portion 212 has first and second ends opposite to each other in the extending direction thereof; the first end of the first bar portion 211 is connected to the grid lines 10, the first end of the second bar portion 212 is connected to the grid lines 10, and the second end of the first bar portion 211 is connected to the second end of the second bar portion 212. As shown in fig. 9A, in the first state, the mesh portion 1 takes the shape of a sheet, the first bar-shaped part 211 extends in the third direction D3, and the third direction D3 is coplanar with and intersects the first direction D1 and the second direction D2; the second bar portion 212 extends along a fourth direction D4, the fourth direction D4 being coplanar with and intersecting the first direction D1, the second direction D2, and the third direction; as shown in fig. 9B, in the second state, the mesh portion 1 has a substantially cylindrical shape, and the first strip portion 211 and the second strip portion 212 constitute a cone structure. For example, the pyramidal structure has a tip projecting in a direction away from the mesh portion 1, which is advantageous in reducing the resistance experienced by the nerve electrode structure 100 during implantation into the target tissue.

For example, the nerve electrode structure 100 also includes an implantation hole H1, and thus can be implanted into a target tissue by using a plurality of implantation methods, and can be implanted by using a self-assembly method, implantation assisted by a rigid auxiliary implantation member, or an implantation method combining self-assembly and implantation assisted by a rigid auxiliary implantation member, so as to meet the requirements of different implantation methods, and match different implantation target tissues and signal acquisition requirements. A specific implantation method of the neural electrode structure 100 shown in fig. 9A to 9B can be referred to the description of the implantation method of the neural electrode structure shown in fig. 6A. The first strip-shaped part 211 and the second strip-shaped part 212 are beneficial to improving the structural stability of the auxiliary implantation part, and especially, during the implantation of the neural electrode structure by adopting a self-assembly method, the first strip-shaped part 211 and the second strip-shaped part 212 not only can greatly enhance the structural stability of the auxiliary implantation part 2 and prevent the deformation thereof, but also the cone structure formed by the first strip-shaped part 211 and the second strip-shaped part 212 can significantly reduce the resistance force applied during the implantation of the neural electrode structure 100 into the target tissue, so that the auxiliary implantation part 2 can smoothly penetrate into the target tissue.

For example, as shown in fig. 9A, the plurality of first grid lines 101 includes first edge grid lines 10a and second edge grid lines 10b; in the first state, the first edge grid lines 10a and the second edge grid lines 10b are the first grid lines 101 located outermost in the second direction D2, respectively, and are opposed to each other; in the second state, the first edge grid lines 10a and the second edge grid lines 10b are aligned with each other, that is, the first edge grid lines 10a and the second edge grid lines 10b are in contact, for example, they are completely aligned (in the first direction, the positions of the first edge grid lines 10a over the entire length thereof are in contact with the positions of the second edge grid lines 10b over the entire length thereof), or they may not be completely aligned (a part of the first edge grid lines 10a are in contact with a part of the second edge grid lines 10 b); alternatively, in some embodiments, the first edge grid lines 10a and the second edge grid lines 10b are spaced apart or spaced apart from each other such that the first edge grid lines 10a and the second edge grid lines 10b do not touch; the first ends of the first bar-shaped parts 211 are connected with the first edge grid lines 10a, and the first ends of the second bar-shaped parts 212 are connected with the second edge grid lines 10b, so that the structural stability of the auxiliary implantation part is further improved, and in the process of implanting the neural electrode structure by adopting a self-assembly method, the first bar-shaped parts 211 and the second bar-shaped parts 212 not only can greatly and obviously enhance the structural stability of the auxiliary implantation part 2 and prevent the auxiliary implantation part 2 from deforming, so that the auxiliary implantation part 2 can be smoothly implanted into a target tissue.

For example, a connection portion where the second end of the first bar-shaped portion 211 and the second end of the second bar-shaped portion 212 are connected is a tip E6 protruding in a direction away from the mesh part 1, and the tip E6 constitutes a tip of a pyramidal structure of the nerve electrode structure 100 in the second state. For example, the connection site is provided with an auxiliary implantation member such as an implantation hole H1, which is configured such that the rigid auxiliary implantation member 4 can be connected with the auxiliary implantation portion 2 of the nerve electrode structure 100 through the auxiliary implantation member. The specific type of the auxiliary implant member is not limited to the implant hole, and specific reference may be made to the previous description of the auxiliary implant member.

For example, as shown in fig. 9A, the bar-shaped portion further includes a third bar-shaped portion 213, the third bar-shaped portion 213 having a first end and a second end opposite to each other in the axial direction, the first end of the third bar-shaped portion being connected to the grid lines 10; the third bar portion 213 is also connected to the second end of the first bar portion 211 and the second end of the second bar portion 212 at a position where the coupling portion of the implant hole H1 is provided. In the first state, the mesh part 1 is sheet-shaped, and the third strip-shaped portion 213 extends in the axial direction; in the second state, the mesh portion 1 is substantially cylindrical, and the first strip portion 211, the second strip portion 212, and the third strip portion 213 constitute a cone structure. The third strip portion 213 further enhances the strength and structural stability of the auxiliary implanting portion 2, prevents the auxiliary implanting portion 2 from being deformed, and allows the auxiliary implanting portion 2 to be smoothly implanted into a target tissue.

As shown in FIG. 9A, for example, the reference electrode site 120 is located on the middle first grid line 101, and is connected to an external circuit through the reference signal line 110 of the middle first grid line 101. For example, the neural electrode structure 100 has only one reference electrode site 120, but may have a plurality of reference electrode sites 120.

The other structures of the neural electrode structure 100 shown in fig. 9A-9B are the same as in the previous embodiment, and reference is also made to the previous description for the implantation method.

The implantation of the neural electrode structure shown in fig. 9A-9B into the target tissue can be achieved by a self-assembling implantation method, or an implantation method combining self-assembling with a rigid auxiliary implantation member, or a method of directly implanting the sheet-like neural electrode structure in the first state by using a rigid auxiliary implantation member.

For example, a second end of the third bar-shaped portion 213 protrudes beyond the second end of the first bar-shaped portion 211 and the second end of the second bar-shaped portion 212 in a direction away from the mesh part 1 in the axial direction, and the second end of the third bar-shaped portion is provided with an auxiliary implant component configured such that the rigid auxiliary implant member 4 can be connected with the auxiliary implant part 2 of the neural electrode structure 100 through the auxiliary implant component.

FIG. 10A is a schematic diagram of another example of a neural electrode structure in a first state, according to one embodiment of the present invention; FIG. 10B is a schematic diagram of the neural electrode structure shown in FIG. 10A in a second state. The embodiment shown in fig. 10A has the following differences from the embodiment shown in fig. 9A.

The implantation of the neural electrode structure shown in fig. 10A into the target tissue can be achieved by an implantation method combining self-assembly with a rigid auxiliary implantation member, or by a method of directly implanting the sheet-like neural electrode structure in the first state by using a rigid auxiliary implantation member.

As shown in fig. 10A to 10B, for example, the auxiliary implanting portion 2 further includes a protrusion 215 connected to the first, second and

third bars

211, 212 and 213, and the protrusion 215 is provided with an auxiliary implanting member such as an implanting hole H1. The protrusion 215 facilitates the introduction of the auxiliary implant part 2 into the target tissue.

As shown in fig. 10C, during the implantation of the neural electrode structure shown in fig. 10A by using the implantation method combining self-assembly and rigid auxiliary implantation member, the neural electrode structure 100 self-curls or self-assembles to more firmly attach to the outer surface of the rigid auxiliary implantation member 4 by using the rigid auxiliary implantation member 4 as a shaft, thereby greatly assisting in enhancing the rigidity of the protrusion 215 and facilitating to reduce the resistance of the protrusion 215 to penetrate into the target tissue. Other structures of the neural electrode structure 100 shown in fig. 10A-10B are the same as those in the previous embodiment, and reference is also made to the previous description for the implantation method. Other features and corresponding technical effects of the embodiment shown in fig. 10A may be found in reference to the description of the embodiment shown in fig. 9A.

FIG. 11A is a schematic diagram of another example of a neural electrode structure in a first state, according to an embodiment of the present invention; FIG. 11B is a schematic diagram of the neural electrode structure shown in FIG. 11A in a second state. The embodiment shown in fig. 11A-11B differs from the embodiment shown in fig. 10A-10B in the following way.

As shown in fig. 11A, the strip portion of the auxiliary implanting portion 2 includes a plurality of fourth bar portions 214, each of the plurality of fourth bar portions 214 having a first end and a second end opposite to each other in the axial direction, which is the same as the first direction D1 in the drawing in fig. 11A; a first end of each of the plurality of fourth bars 214 is connected to the grid line 10, for example, each fourth bar 214 is located on an extension of a corresponding one of the first grid lines 101; a first partial fourth bar-shaped portion 214a of the plurality of fourth bar-shaped portions 214 has a second end connected to the first bar-shaped portion 211, and a second partial fourth bar-shaped portion 214b of the plurality of fourth bar-shaped portions 214 has a second end connected to the second bar-shaped portion 212; as shown in fig. 11A, in the first state, the mesh portion 1 is sheet-shaped, and a plurality of fourth strip portions 214 are arranged at intervals from each other in a lateral direction perpendicular to the axial direction and each extend in the axial direction, and in the present embodiment, the lateral direction is the same as the second direction D2; as shown in fig. 11B, in the second state, the mesh part 1 has a substantially cylindrical shape, and the plurality of fourth strip portions 214 (including the first partial fourth strip portion 214a and the second partial fourth strip portion 214B), the first strip portion 211, and the second strip portion 212 constitute a pyramidal structure. The plurality of fourth bar-shaped portions 214 (including the first portion, the fourth bar-shaped portion 214a and the second portion, the fourth bar-shaped portion 214 b) and the first bar-shaped portion 211 and the second bar-shaped portion 212 are beneficial to improve the structural stability of the auxiliary implantation portion, the first bar-shaped portion 211 and the second bar-shaped portion 212 not only can greatly enhance the structural stability of the auxiliary implantation portion 2 and prevent the auxiliary implantation portion from being deformed, but also the cone structure formed by the plurality of fourth bar-shaped portions 214 (including the first portion, the fourth bar-shaped portion 214a and the second portion, the fourth bar-shaped portion 214 b) and the first bar-shaped portion 211 and the second bar-shaped portion 212 can significantly reduce the resistance suffered by the neural electrode structure 100 during the implantation process into the target tissue, so that the auxiliary implantation portion 2 smoothly penetrates into the target tissue.

As shown in fig. 11B, during the implantation of the neural electrode structure shown in fig. 10A by using the implantation method of combining self-assembly with the rigid auxiliary implantation member, the neural electrode structure 100 self-curls or self-assembles to be more firmly attached to the outer surface of the rigid auxiliary implantation member 4 by using the rigid auxiliary implantation member 4 as a shaft, thereby greatly assisting in enhancing the rigidity of the protrusion 215 and advantageously reducing the resistance of the protrusion 215 to penetrate into the target tissue.

The implantation of the neural electrode structure shown in fig. 11A into the target tissue can be achieved by an implantation method combining self-assembly with a rigid auxiliary implantation member, or by a method of directly implanting the sheet-like neural electrode structure in the first state by using a rigid auxiliary implantation member.

The non-mentioned other structures and corresponding technical effects of the neural electrode structure 100 shown in fig. 11A-11B are the same as those of the embodiment shown in fig. 11A, and various implantation methods can be used, for example, a self-assembly implantation method, a rigid auxiliary implantation member auxiliary implantation method, or an implantation method combining self-assembly and rigid auxiliary implantation member auxiliary implantation can be used, and the specific steps can be referred to the previous description.

At least one embodiment of the present invention provides an implanting method of a neural electrode structure, the implanting method including: the strip-shaped part of the auxiliary implantation part is implanted into target tissue, so that the grid part is implanted into the target tissue under the driving of the auxiliary implantation part. The nerve electrode structure provided by the embodiment of the invention can be implanted into target tissues by adopting a self-assembly method, a rigid auxiliary implantation member auxiliary implantation method and a method combining the self-assembly method and the rigid auxiliary implantation member auxiliary implantation method.

Fig. 12A is a flowchart of a method for implanting a neural electrode structure according to an embodiment of the present invention. For example, as shown in FIG. 12A, a method for implanting a neural electrode structure includes the following steps S11 to S12:

step S11: covering a surface of the neural electrode structure with an auxiliary implant substance to cause self-assembly of the neural electrode structure such that the neural electrode structure transitions from the first state to the second state;

step S12: implanting the auxiliary implant portion into the target tissue, the mesh portion in the second state being implanted into the target tissue with the auxiliary implant portion, wherein the auxiliary implant substance dissolves and/or disintegrates to uncover the electrode sites.

FIG. 12B is a flowchart of another method for implanting a neural electrode structure, in accordance with an embodiment of the present invention. For example, as shown in FIG. 12B, a method for implanting a neural electrode structure includes the following steps S21 to S23:

step S21: connecting a first end of a rigid auxiliary implant member with an auxiliary implant portion of the nerve electrode structure through the auxiliary implant component;

step S22: inserting a first end of the rigid auxiliary implant member into the target tissue and then sequentially implanting the auxiliary implant portion and the mesh portion into the target tissue; and

step S23: and pulling the rigid auxiliary implantation member out of the rigid auxiliary implantation member, wherein the nerve electrode structure is retained in the target tissue.

For a detailed description of the implantation method shown in fig. 12A and 12B, reference is made to the detailed description of the implantation method steps in the previous embodiments of the neural electrode structure, and the description is not repeated here.

At least one embodiment of the present invention provides a method for manufacturing a neural electrode structure, which can be used to manufacture the flexible neural electrode structure described above, and can also be used to manufacture the flexible neural electrode array described above. As an example, a method of making the implantable stretchable flexible neural electrode will be described below; it should be noted that the method can be used to fabricate an implantable stretchable flexible neural electrode set and an implantable stretchable flexible neural electrode array.

FIG. 13A is a schematic flow chart of a method of fabricating a flexible neural electrode structure, in accordance with an embodiment of the present invention; fig. 13B is a schematic cross-sectional view of steps in a method of fabricating a flexible neural electrode structure, in accordance with an embodiment of the present invention. According to the embodiment of the invention, the manufacturing method of the implanted stretchable flexible nerve electrode comprises the following steps: step MS1 of providing a substrate 1000, wherein the substrate 1000 includes a first region and a second region, as shown in part (a) of the cross-sectional view shown in fig. 13B; step MS2 of forming a first insulating layer 131 on the substrate 1000 as shown in part (c) of the cross-sectional view shown in fig. 13B; step MS3 of forming a conductive layer on the first insulating layer 131, patterning the conductive layer to form the data signal line 11 including the electrode site 12 in the first region of the substrate 1000, as shown in part (d) of the cross-sectional view shown in fig. 13B; a step MS4 of forming a second insulating layer 132 on the data signal line 11 as shown in part (e) of the sectional view shown in fig. 13B; step MS5 of patterning the first insulating layer 131 and the second insulating layer 132 to form a flexible insulating portion 13 that wraps part of the data signal line 11, as shown in part (f) of the cross-sectional view shown in fig. 13B, and patterning the second insulating layer 132 to expose the electrode sites 12, thereby forming the auxiliary implanted portion 2 and the neural electrode structure constituted by the data signal line 11 and the flexible insulating portion 13 as described above, the auxiliary implanted portion 2 including a strip portion whose first end in its extending direction is connected to the mesh portion 1 and whose second end opposite to the first end is distant from the mesh portion 1; and a step MS6 of removing at least a portion of the substrate 1000 located in the first region, as shown by a portion (g) in the cross-sectional view shown in fig. 13B.

The first region is a region of the substrate 1000 where the first and second insulating

layers

131 and 132 are formed and the data signal line 11, and the second region is a portion of the substrate 1000 at least partially surrounding the first region.

For example, in step MS1, the substrate 1000 is a silicon wafer or a glass sheet; providing the substrate 1000 includes pre-treating the substrate 1000, such as: the substrate 1000 is cleaned with acetone and isopropanol, then cleaned with water and then baked, and then cleaned with oxygen plasma. For example, in step MS6, a portion of the substrate 1000 located in the second region is left or removed; for example, the pad 8 is formed in the second region. For example, a portion of the substrate 1000 located in the second region is left to reduce the operation difficulty of removing the substrate 1000 and to ensure the structural stability of the bonding pad 8 in the second region. For example, the "patterning" process in step MS3 and step MS5 includes: coating, exposing, and developing the photoresist to form a photoresist pattern, and forming the layers into a desired pattern using the photoresist pattern as a mask.

For example, the material of the first and second insulating layers may be a biocompatible polymer with good insulating properties to better fuse with the target tissue, e.g. the biocompatible polymer comprises at least one of polyimide, SU-8, parylene, fibroin.

For example, the patterned conductive layer simultaneously forms an electrical input-output interface for connecting the data signal line 11 with an external circuit.

For example, according to an embodiment of the present invention, the method for manufacturing the implantable stretchable flexible neural electrode further includes: before forming the first insulating layer 131 over the substrate 1000, a sacrificial layer 133 is formed at least in the first region of the substrate 1000, as shown in part (B) of the cross-sectional view shown in fig. 13B; removing at least a portion of the substrate 1000 located in the first region includes: the sacrificial layer 133 is removed and the substrate 1000 is cut to remove at least a portion of the substrate 1000 located in the first region. For example, the material of the sacrificial layer 133 includes at least one of aluminum, PMMA, and nickel; further preferably comprising aluminum. The sacrificial layer 133 is formed by, for example, evaporation or sputtering. The sacrificial layer is removed, for example, in an etching solution.

For example, according to an embodiment of the present invention, step MS3 further includes: patterning the conductive layer to form a pad 8 in a second region of the substrate 1000 while forming a data signal line 11 including an electrode site 12 in a first region of the substrate 1000, the data signal line 11 being electrically connected to the pad 8; and step MS5 further comprises: the second insulating layer 132 is patterned to expose the pad 8.

Part (a) of fig. 2B shows the first insulating layer 131 after patterning, part (B) of fig. 2B shows the data signal line 11 including the electrode site 12, and part (c) of fig. 2B shows the second insulating layer 132 after patterning. Referring to part (c) of fig. 2B, the patterned second insulating layer 132 includes an opening 20h1 to expose the electrode site 12.

Part (a) of fig. 2B shows the patterned first insulating layer 131, part (B) of fig. 2B shows the data signal line 11 including the electrode site 12 and the pad 8 connected thereto, and part (c) of fig. 2B shows the patterned second insulating layer 132. Referring to part (c) of fig. 2B, the patterned second insulating layer 132 includes an opening 20h2 to expose the pad 8.

Other features and corresponding technical effects of the flexible neural electrode structure manufactured by the method according to the embodiment of the present invention may refer to the above description, and are not described herein again.

The above description is intended to be illustrative of the present invention and is not intended to limit the scope of the invention, which is defined by the appended claims.

Claims

1. A neural electrode structure, comprising: a flexible mesh portion and a flexible auxiliary implant portion connected to each other,

the grid part comprises grid lines, the grid lines comprise data transmission grid lines, the data transmission grid lines comprise data signal lines and an insulating part, and the insulating part wraps part of the data signal lines; the data signal line comprises an electrode site, the insulating part exposes the electrode site, and the electrode site is exposed in a vacant lattice area defined by the grid lines or exposed on the surface of the data transmission grid lines;

the auxiliary implantation portion includes a plurality of bar-shaped portions, each of the plurality of bar-shaped portions being connected with the mesh portion at a first end thereof in an extending direction thereof, and each of the plurality of bar-shaped portions having a second end thereof opposite to the first end thereof remote from the mesh portion;

the neural electrode structure has a first state and a second state;

in the first state, the nerve electrode structure is in a sheet shape, the electrode sites are exposed in the vacant grid areas defined by the grid lines or exposed on the surfaces of the data transmission grid lines, and the first ends of the strip-shaped parts are directly connected with the grid parts and are spaced from each other;

in the second state, the grid part of the nerve electrode structure is columnar, the electrode sites are positioned on the surface of the columnar grid part and exposed in empty grid areas defined by grid lines of the columnar grid part or exposed on the surface of the data transmission grid lines, the first ends of the strip parts are kept spaced apart from each other and the second ends of the strip parts are converged to enable the strip parts to form a cone structure;

the mesh part and the auxiliary implantation part of the neural electrode structure in the shape of a sheet in the first state are both curled around an axis extending along the axial direction to be converted into the second state;

the flexible grid lines comprise a plurality of first grid lines and a plurality of second grid lines;

in the first state, the first grid lines extend along a first direction, the second grid lines extend along a second direction, the first direction intersects with the second direction and is the same as the axial direction, and the first ends of the strip-shaped portions are connected with the first grid lines or the second grid lines;

the plurality of bar portions are not provided with the electrode sites, and the number of the plurality of bar portions is smaller than the number of the first grid lines.

2. The neural electrode structure of claim 1,

in the first state, the mesh part is sheet-shaped, the plurality of strip-shaped portions are arranged at intervals in a transverse direction perpendicular to the axial direction and each extend in the axial direction, and second ends of the plurality of strip-shaped portions are spaced from each other;

in the second state, the mesh portion is substantially cylindrical, the second ends of the plurality of bars converge and the first ends of the plurality of bars remain spaced apart from one another such that the plurality of bars form a pyramidal structure.

3. The nerve electrode structure of claim 2, wherein the second end of at least one of the plurality of strips is provided with an auxiliary implant component configured such that a rigid auxiliary implant member is connectable with an auxiliary implant portion of the nerve electrode structure through the auxiliary implant component.

4. The neural electrode structure of claim 2, wherein each of the plurality of bar portions connects one of the first grid lines.

5. The neural electrode structure of claim 4, wherein the second end of each of the plurality of bar-shaped portions is a tip protruding in a direction away from the mesh portion.

6. The neural electrode structure of claim 1, wherein the plurality of bar portions includes a first bar portion and a second bar portion; the first strip-shaped part has a first end and a second end opposite to each other in the extending direction thereof, and the second strip-shaped part has a first end and a second end opposite to each other in the extending direction thereof; the first end of the first strip-shaped part is connected with the grid lines, the first end of the second strip-shaped part is connected with the grid lines, and the second end of the first strip-shaped part is connected with the second end of the second strip-shaped part;

in the first state, the mesh part is sheet-shaped, the first bar-shaped part extends along a third direction, and the third direction is coplanar with and intersects with the first direction and the second direction; the second bar portion extends along a fourth direction that is coplanar with and intersects the first direction, the second direction, and the third direction;

in the second state, the mesh portion is substantially cylindrical, and the first strip portion and the second strip portion form a cone structure.

7. The neural electrode structure of claim 6, wherein the plurality of first grid lines includes a first edge grid line and a second edge grid line;

in the first state, the first edge grid lines and the second edge grid lines are respectively first grid lines located outermost in the second direction and are opposed to each other;

in the second state, the first edge grid lines and the second edge grid lines are involuted with each other or have a certain distance therebetween;

the first end of the first strip-shaped portion is connected with the first edge grid line, and the first end of the second strip-shaped portion is connected with the second edge grid line.

8. The neural electrode structure of claim 6,

the second end of the first strip-shaped part and the second end of the second strip-shaped part are connected to form a connecting part which is a tip protruding in the direction far away from the grid part, and an auxiliary implantation part is arranged at the connecting part and is configured to enable a rigid auxiliary implantation component to be connected with the auxiliary implantation part of the nerve electrode structure through the auxiliary implantation part.

9. The neural electrode structure of claim 6, wherein the plurality of bars further comprises a third bar having first and second ends opposite each other in the axial direction, the first end of the third bar being connected to the grid lines; the third strip-shaped part is also connected with the second end of the first strip-shaped part and the second end of the second strip-shaped part;

in the first state, the grid part is sheet-shaped, and the third strip-shaped part extends along the axial direction;

in the second state, the mesh portion is substantially cylindrical, and the first, second and third bars form a pyramidal structure.

10. The neural electrode structure of claim 9, wherein the second end of the third bar portion protrudes beyond the second ends of the first and second bar portions in the axial direction in a direction away from the mesh portion, the second end of the third bar portion being provided with an auxiliary implant component configured such that a rigid auxiliary implant member can be connected with the auxiliary implant portion of the neural electrode structure through the auxiliary implant component.

11. The neural electrode structure of any one of claims 6 to 9, wherein the auxiliary implant portion includes a plurality of fourth bars, each of the plurality of fourth bars having a first end and a second end opposite to each other in the axial direction, the first end of each of the plurality of fourth bars being connected to the gridlines; a first portion of the plurality of fourth bar-shaped portions having second ends connected to the first bar-shaped portion and a second portion of the plurality of fourth bar-shaped portions having second ends connected to the second bar-shaped portion;

in the first state, the mesh part is sheet-shaped, and the plurality of fourth strip-shaped parts are arranged at intervals in a transverse direction perpendicular to the axial direction and extend in the axial direction;

in the second state, the mesh portion is substantially cylindrical, and the plurality of fourth bars, the first bars, and the second bars form a cone structure.

12. The nerve electrode structure of any one of claims 3, 8 and 10, wherein the auxiliary implant component is an implant hole extending through the strip; or,

the auxiliary implantation part is a groove which is sunken from the surface of the strip-shaped part; or,

the auxiliary implantation part is a protrusion protruding from the surface of the bar-shaped part.

13. The neural electrode structure of any one of claims 1-10, wherein the first grid line or the second grid line further comprises:

a reference grid line, wherein the reference grid line comprises a reference signal line and a reference insulation part, and the reference insulation part wraps a part of the reference signal line; the reference signal line includes a reference electrode site, and the reference insulation exposes the reference electrode site;

in the second state, the reference electrode site is located on an outer surface of the columnar lattice section.

14. The neural electrode structure of any one of claims 1-10,

the grid part comprises a plurality of layers of data transmission grid lines which are stacked in a direction perpendicular to a plane where the sheet-shaped neural electrode structure extends, and the electrode sites of the data transmission grid lines positioned on different layers are staggered with each other; or,

the grid part comprises a plurality of layers of grid lines which are arranged in a stacked mode, and the electrode sites of the grid lines located on different layers are staggered with each other.

15. The neural electrode structure of any one of claims 1-10,

at least part of the plurality of first gridlines being the data transmission gridlines, and/or,

at least a portion of the plurality of second gridlines are the data transmission gridlines.

16. The neural electrode structure of any one of claims 1-10, wherein the mesh portion has first and second ends opposite each other in the axial direction;

the electrode sites are located at first ends of the data signal lines, and second ends of the data signal lines, different from the first ends thereof, are drawn out from first ends of the mesh portions to be connected to a data processing circuit;

the first end of the auxiliary implant portion is connected to the second end of the mesh portion.

17. A method of making a neural electrode structure, comprising: forming a flexible mesh portion and a flexible auxiliary implant portion connected to each other, wherein forming the mesh portion comprises:

forming flexible grid lines, wherein the grid lines comprise data transmission grid lines, the data transmission grid lines comprise data signal lines and an insulating part, and the insulating part wraps a part of the data signal lines; the data signal lines comprise electrode sites, the insulating parts expose the electrode sites, and the electrode sites are exposed in the empty grid areas defined by the grid lines or exposed on the surfaces of the data transmission grid lines;

the neural electrode structure has a first state and a second state;

in the first state, the nerve electrode structure is in a sheet shape, the electrode sites are exposed in the empty grid areas defined by the grid lines or exposed on the surfaces of the data transmission grid lines, and the first ends of the strip-shaped parts are directly connected with the grid parts and are spaced from each other;

in the first state, the first grid lines extend along a first direction, the second grid lines extend along a second direction, the first direction intersects with the second direction and is the same as the axial direction, and the first ends of the strip-shaped parts are connected with the first grid lines or the second grid lines;