Neural interface with supporting structure

JP2025505778AActive Publication Date: 2025-02-28WUHAN NEURACOM TECH DEV CO LTD
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Patent Information

Application Number
JP2024548420
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-02-25
Filing Date
2022-10-21
Publication Date
2025-02-28
Estimated Expiration
2042-10-21

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Abstract

The present application belongs to the technical field of neural interfaces, and specifically, to a neural interface having an auxiliary structure. The neural interface includes at least one flexible electrode and at least one auxiliary structure, and the flexible electrode is assembled to one side of the auxiliary structure. The present application provides a neural interface, in which the auxiliary structure has rigidity, and the flexible electrode is detachably assembled to the auxiliary structure, so that the flexible electrode can be easily implanted into neural tissue with the assistance of the auxiliary structure, and then the auxiliary structure can be removed to leave only the flexible electrode in the brain tissue. The flexible electrode can adaptively deform according to the expansion and contraction state of a blood vessel, thereby reducing damage caused by implantation.
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Description

[Technical field]

[0001] The present application relates to the technical field of neural interfaces, and in particular to neural interfaces having support structures. [Background technology]

[0002] A neural interface is a communication system that does not depend on the normal output pathway consisting of peripheral nerves and muscles, and provides a new pathway for exchanging information with an external device by bypassing peripheral nerves and muscle tissue, and can stimulate nerve cells to generate action potentials by an external device and record the action potentials generated by the nerve cells, thereby realizing two-way communication between the nerve cells and the external device. Therefore, neural interfaces are widely used in the research and treatment of various neurological disorders, including the human optic nerve system.

[0003] Neural interface devices are mainly divided into two types: implantable and non-implantable. Compared with non-implantable neural electrodes, implantable neural electrodes have attracted attention from researchers at home and abroad due to their high resolution. Currently, most implantable microneedle structures adopt methods such as EcoG, Utah electrodes, Michigan electrodes, and sewing machine flexible electrodes. Among implantable neural electrodes, microneedle array electrodes, represented by Utah electrodes, have relatively high spatial resolution and can have the highest stability even after long-term implantation. They are the only neural interface devices approved for use in humans by the U.S. Food and Drug Administration (FDA). However, when using the neural interface devices of the prior art specifically, it is difficult because a craniotomy is required when implanting the implantable microneedles. In addition, the implantation method causes significant damage due to implantation, affects the activity and growth of organ tissues, and is not suitable for long-term implantation. Therefore, a better solution is needed to solve the problems existing in the prior art. Summary of the Invention [Problem to be solved by the invention]

[0004] The main objective of this application is to propose a neural interface with an auxiliary structure to solve the technical problem that conventional implantable neural interface microneedle arrays cause significant damage to brain tissue and cannot be implanted for a long period of time. [Means for solving the problem]

[0005] In order to solve the above technical problems, according to one aspect of the present application, the present application provides a technical solution as follows: a neural interface is provided, the neural interface includes at least one flexible electrode and at least one auxiliary structure, the flexible electrode is assembled to one side of the auxiliary structure, and the flexible electrode is provided with a ring-shaped structure including at least one of a through hole and a groove.

[0006] Furthermore, the auxiliary structure includes an auxiliary member, which can be received in the through hole or the groove, so that the flexible electrode and the auxiliary structure are tightly connected.

[0007] Furthermore, the auxiliary member includes a fixing portion fixed to an end of the auxiliary structure and a connecting portion receivable within the through hole.

[0008] Additionally, the support structure is made from a biocompatible material.

[0009] Additionally, the auxiliary structure is an auxiliary needle housed within the recess.

[0010] Furthermore, the flexible electrodes and the auxiliary structures are provided in one-to-one correspondence.

[0011] Furthermore, the flexible electrode is provided with at least one slit.

[0012] Compared with the prior art, the present application has the following beneficial effects:

[0013] The present application provides a neural interface, in which an auxiliary structure has rigidity, and a flexible electrode is removably attached to the auxiliary structure, so that the flexible electrode can be easily implanted into neural tissue with the assistance of the auxiliary structure, and then the auxiliary structure can be removed to leave only the flexible electrode in the brain tissue. The flexible electrode can adaptively deform according to the expansion and contraction state of a blood vessel, thereby reducing damage caused by implantation.

[0014] In order to more clearly describe the technical solution of the present application, the following briefly describes the accompanying drawings that need to be used in the embodiments. It should be understood that the following accompanying drawings only show some embodiments of the present application, and should not be regarded as a limitation on the protection scope of the present application. In each drawing, similar components are given similar numbers. [Brief description of the drawings]

[0015] [Figure 1] FIG. 2 is an exploded structural schematic diagram of a microneedle-assisted implantable neural interface proposed in accordance with an embodiment of the present application. [Diagram 2] FIG. 2 is a schematic diagram of the individual structures of a microneedle-assisted implantable neural interface proposed in accordance with an embodiment of the present application. [Diagram 3] FIG. 1 is a schematic diagram of the array structure of a microneedle-assisted implantable neural interface proposed in accordance with an embodiment of the present application. [Figure 4] 1 is a structural schematic diagram of a flexible electrode proposed in an embodiment of the present application. [Diagram 5] 4 is a structural schematic diagram showing the fitting of an auxiliary structure and a flexible electrode proposed in an embodiment of the present application. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] In the following, the technical solutions in the embodiments of the present application will be described clearly and completely in combination with the drawings in the embodiments of the present application. It is obvious that the described embodiments are not all the embodiments of the present application, but are only some of the embodiments of the present application.

[0017] Generally, the components of the embodiments of the present application described and illustrated in the drawings herein can be arranged and designed in a variety of different configurations. Therefore, the detailed description of the embodiments of the present application provided in the following drawings is not intended to limit the scope of the application for which protection is sought, but merely represents selected embodiments of the present application. All other embodiments that can be obtained by a person skilled in the art based on the embodiments of the present application without creative labor fall within the scope of protection of the present application.

[0018] Hereinafter, the terms "comprise", "have" and their conjugations as may be used in various embodiments of the present application are intended only to represent certain features, numbers, steps, operations, elements, components or combinations thereof, and should not be interpreted as precluding the presence of one or more other features, numbers, steps, operations, elements, components or combinations thereof, or the possibility of adding one or more features, numbers, steps, operations, elements, components or combinations thereof.

[0019] Additionally, the terms "first," "second," "third," etc. are used merely to distinguish the descriptions and should not be understood as indicating or implying relative importance.

[0020] Unless otherwise limited, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by a person skilled in the art to which each embodiment of the present application belongs. The above-mentioned terms (e.g., terms defined in a commonly used dictionary) are interpreted as having the same meaning as the contextual meaning in the relevant technical field unless clearly defined in various embodiments of the present application, and are not interpreted as having an idealized meaning or an overly formal meaning.

[0021] Example 1 As shown in Figs. 1-2, the present application provides a neural interface, the neural interface includes an integrated circuit chip 1 and at least one flexible electrode 2, a ring structure 4 is provided at the end of the flexible electrode, the ring structure includes at least one of a through hole and a groove, the through hole is in the same direction as the length of the flexible electrode, and the flexible electrode 2 may be made of a flexible material. In the present application, the material of the flexible material is not particularly limited as long as it is harmless to human tissue. According to an embodiment of the present application, the material of the flexible electrode 2 is preferably one or more of silicone rubber, PDMS, and polyimide. The flexible electrode 2 is electrically connected to the integrated circuit chip 1, and the flexible electrode 2 includes at least one bioelectrode point 3, which can realize the output of a signal and the input of a weak electrical stimulation signal. The flexible electrode 2 is provided with a ring structure 4 at the end, and the structure of the ring structure 4 and the connection relationship with the flexible electrode 2 are not particularly limited in the present application, and the ring structure 4 may be attached to the flexible electrode 2 from the outside, and the material may be metal or other flexible or rigid materials. The annular structure may be integrally formed with the base material of the flexible electrode 2 and provided at the end of the flexible electrode 2 .

[0022] The neural interface further includes at least one support structure 5, the flexible electrodes and the support structure are provided in one-to-one correspondence, and the flexible electrodes are removably assembled to one side of the support structure.

[0023] In other embodiments, the number of support structures may be less than the number of flexible electrodes, provided that the support structures are capable of implanting the flexible electrodes to the target location.

[0024] Here, the bioelectrode point 3 is provided on the front side of the flexible electrode 2 , the ring structure 4 is provided on the rear side of the flexible electrode 2 , and the auxiliary structure is also provided on the rear side of the flexible electrode 2 .

[0025] In a preferred embodiment, the auxiliary structure 5 includes an auxiliary needle and an auxiliary member 6 provided on the surface of the auxiliary needle, and the auxiliary member includes a fixing part fixed to the end of the auxiliary structure and a connecting part that can be accommodated in the through hole. Here, the auxiliary member can be a hook, which can be accommodated in the through hole so that the flexible electrode and the auxiliary structure are tightly connected, and can be fitted into the ring structure 4 at the end of the flexible electrode 2 to form a detachable connection.

[0026] The auxiliary member 6 in this application is very small, and the damage to organ tissues when inserted together with the auxiliary structure 5 can be almost negligible. During use, the annular structure 4 at the end of the flexible electrode 2 is hung on the auxiliary member 6 of the auxiliary structure 5 and inserted together into brain tissue, and then the auxiliary structure 5 is removed, and the auxiliary member 6 is separated from the annular structure 4 of the flexible electrode 2, leaving the flexible electrode 2 in the brain tissue, and the auxiliary structure 5 is removed outside the body, without causing damage due to long-term implantation.

[0027] As shown in FIG. 5, in one preferred embodiment of the present application, in order to facilitate the separation process and prevent the flexible electrode 2 from being pulled out when the auxiliary structure 5 is pulled out, the inner ring surface at the top of the annular structure 4 has an inclined structure, inclined toward the side that is attached to the auxiliary structure 5, and both the inside and outside of the hook have a certain curvature.

[0028] In another embodiment, the auxiliary member may be a protruding block, which is received in the groove and forms a detachable connection with the groove. In this embodiment, the lower end of the groove is provided with a blocking portion to prevent the protruding block from sliding out of the groove.

[0029] Here, the material forming the auxiliary member includes silicon dioxide or silicon nitride. Specifically, the hook can be formed as follows: after preparing the auxiliary structure body, a groove is etched at a predetermined position of the auxiliary structure body, and a pattern of the hook is defined using photoresist, silicon dioxide or silicon nitride is grown from the groove along the predefined pattern to form the hook, and the remaining photoresist is removed.

[0030] In another preferred embodiment, the auxiliary structure includes an auxiliary needle housed in the groove, and the groove is longer and has a length adapted to the length of the auxiliary needle.

[0031] In a preferred embodiment, the flexible electrode may be based on a flexible material to ensure that the flexible electrode can be deformed under the action of an external force, where the flexible material comprises PDMS to ensure that the electrode is in contact with the neural tissue in a more flexible state.

[0032] In another preferred embodiment, the flexible electrode is provided with at least one slit. When the flexible electrode is provided with at least two slits, the slits are spaced apart in the length direction of the flexible electrode, and adjacent two slits are offset from each other. The slits are perpendicular or inclined to the length direction of the flexible electrode to allow deformation of the flexible electrode.

[0033] Specifically, the flexible electrode may have a rigid material as a base material. Specifically, the bioelectrode includes a substrate and a plurality of slits distributed on the substrate. The plurality of slits are arranged at intervals in the length direction of the bioelectrode (hereinafter, for convenience of explanation, described as the first direction), and adjacent two slits are offset from each other. The slits are perpendicular or inclined to the first direction. The slits may be perpendicular to the length direction of the bioelectrode (i.e., the first direction), or may be inclined to the length direction of the bioelectrode. Providing slits in the substrate can reduce the rigidity of the entire bioelectrode to some extent, but in this specification, the size of the slits should not be too small and should be controlled within a certain range so as not to lack flexibility.

[0034] Here, the shape of the slit is not specifically limited, and may be elongated, wavy, sawtooth, or the like.

[0035] The auxiliary structure of the neural interface of this embodiment has rigidity, and the flexible electrode is removably attached to the auxiliary structure, so that the flexible electrode can be easily implanted into neural tissue with the aid of the auxiliary structure, and then the auxiliary structure can be removed to leave only the flexible electrode in the brain tissue. The flexible electrode can adaptively deform according to the expansion and contraction state of the blood vessel, thereby reducing damage caused by implantation.

[0036] Example 2 As shown in Figs. 1-2, in one preferred embodiment of the present application, there are a plurality of the auxiliary structures 5, forming a microneedle array 7. There are also a plurality of the flexible electrodes 2, which are bonded to an integrated circuit chip 1 to form an electrode array. The pitch between the auxiliary structures 5 of the microneedle array 7 is the same as the pitch between the flexible electrodes 2 bonded to the integrated circuit chip 1. When the microneedle array 7 and the flexible electrode array are bonded together, the auxiliary structures 5 and the flexible electrodes 2 are placed in one-to-one correspondence, and the ring-shaped structure 4 and the auxiliary member 6 are accurately fitted together, so that the flexible electrodes 2 can be in a tightened state. The microneedle array 7 and the flexible electrode array are bonded together to form a microneedle electrode assembly. As shown in Fig. 3, a plurality of microneedle electrode assemblies can be combined to form a microneedle electrode array, which can cover a certain area when implanted into brain tissue, improving spatial resolution and signal accuracy.

[0037] Example 3 In one preferred embodiment of the present invention, the microneedle array includes at least two support structures 5 with different lengths, and the positions of the corresponding support members 6 may be coplanar or non-coplanar.

[0038] In another preferred embodiment of the present invention, the position of the auxiliary member 6 on the auxiliary structure 5 is adjustable, and the adjustment method may be sliding adjustment by fitting, or positioning by mounting, and is not particularly limited. According to one embodiment of the present invention, the auxiliary structure 5 is provided with a plurality of mounting holes arranged in the length direction of the auxiliary structure, and the auxiliary member 6 can be engaged and fixed in the mounting holes, so that the engagement position of the auxiliary member 6 can be set according to the length of the flexible electrode 2 that needs to be implanted.

[0039] In another preferred embodiment of the present invention, the flexible electrode 2 can be cut, and can be cut to obtain flexible electrodes 2 of different lengths according to the length of the auxiliary structure 5 and the position of the auxiliary member 6. More preferably, the cutting is performed at the end without the annular structure 5, and the cut cross section of the flexible electrode 2 is provided with a protective film or re-bonded to the integrated circuit chip 1.

[0040] Example 4 As shown in Figures 4-5, the flexible electrode 2 includes at least one bioelectrode point 3, and the bioelectrode points 3 are independent of each other and can be controlled by the integrated circuit chip 1 to operate independently. By providing multiple bioelectrode points 3 on one flexible electrode 2, it is possible to ensure simultaneous signal reading and stimulation. In one preferred embodiment, the bioelectrode points 3 on the flexible electrode 2 may be arranged in the same row or in different rows, depending on the width of the flexible electrode 2 and the actual situation.

[0041] In any possible embodiment, the neural interface further comprises an extracorporeal device including a collection unit and a processing unit, the collection unit being used for acquiring an external sensory signal and the processing unit being used for converting the sensory signal into a stimulation signal for reproducing the sensation.

[0042] In one preferred embodiment, the extracorporeal device further includes a first wireless coil, and a second wireless coil is provided on the integrated circuit chip side, the first wireless coil being used to transmit a stimulation signal, and the second wireless coil being used to receive a stimulation signal.

[0043] Example 5 According to one embodiment of the present application, there is further provided a method for implanting a neural interface, the specific technical solution of which is as follows: (1) Step 1 of selecting an auxiliary structure 5 having a different length or adjusting the position of the auxiliary member 6 in the auxiliary structure according to the implantation depth of the flexible electrode 2; (2) fitting the annular structure 4 of the flexible electrode 2 into the auxiliary member 6 of the auxiliary structure 5, attaching the auxiliary structure 5 to the flexible electrode 2 and the integrated circuit chip 1, and adjusting the flexible electrode 2 to a tightened state; (3) Step 3 of inserting the combined structure of the auxiliary structure 5 and the flexible electrode 2 into brain tissue; (4) adjusting the flexible electrode 2 to a relaxed state, and pulling out the auxiliary structure 5 to realize a separation process.

[0044] In one preferred embodiment of the present invention, in order to facilitate the separation process in step 4, the inner surface of the top of the annular structure in step 2 is inclined towards the side where it is attached to the auxiliary structure.

[0045] The implantation assistance method of the flexible electrode used in the present application can reduce implantation damage and improve long-term implantation stability. In addition, the flexible electrode includes multiple bioelectrodes and can adapt to structural deformation of brain tissue, which can avoid foreign body sensation caused by friction with tissues and organs, and can realize recording by multiple electrodes, improving spatial resolution and signal accuracy.

[0046] The above described examples only show some embodiments of the present application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the scope of the present application. It should be noted that those skilled in the art can make some modifications and improvements without departing from the concept of the present application, all of which are within the scope of protection of the present application. Therefore, the scope of protection of the present application should be subject to the scope of the attached claims. [Explanation of symbols]

[0047] 1 Integrated Circuit Chip 2 Flexible electrodes 3 Bioelectrode points 4. Ring structure 5 Auxiliary structure 6 Auxiliary parts 7. Microneedle Array

Claims

1. At least one flexible electrode and at least one support structure, the flexible electrode being assembled to one side of the support structure. A neural interface characterized by

2. The flexible electrode is provided with an annular structure including at least one of a through hole and a recessed groove.

2. The neural interface according to claim 1 .

3. The support structure includes a support member. A neural interface according to claim 2.

4. The auxiliary member can be received in the through hole or the groove so that the flexible electrode and the auxiliary structure are tightly connected. A neural interface according to claim 3.

5. The auxiliary member includes a fixing portion fixed to an end of the auxiliary structure and a connecting portion that can be accommodated in the through hole. A neural interface according to claim 3.

6. The material forming the support member includes silicon dioxide or silicon nitride. A neural interface according to claim 3.

7. The auxiliary structure is an auxiliary needle accommodated in the groove. A neural interface according to claim 2.

8. The support structure is made of a biocompatible material. A neural interface according to any one of claims 1 to 7.

9. The flexible electrodes and the auxiliary structures are provided in one-to-one correspondence. A neural interface according to any one of claims 1 to 7.

10. The flexible electrode is provided with at least one slit. A neural interface according to any one of claims 1 to 7.

Citation Information

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