Cranial penetration-type nerve flexible electrode

Abstract

The present invention relates to a cranial penetration-type nerve flexible electrode. The cranial penetration-type nerve flexible electrode may comprise: a front end portion having a needle hole; an electrode portion comprising a circuit and at least one of an electrode and a nerve regeneration-inducing electrode; and a terminal portion including a circuit connection pad. The nerve flexible electrode of the present invention enables stable stimulation / measurement at an accurate position for a long period of time, and enables nerve signal analysis and electrical stimulation in various areas.

Description

Cranial penetrating nerve flexible electrode

[0001] The present invention relates to a cranial penetrating neural flexible electrode.

[0002]

[0003] As human life expectancy increases and the elderly population grows, the incidence of degenerative neurological diseases is also rising. Deep Brain Stimulation (DBS), one of the treatment methods for these diseases, is a surgical procedure used to treat neurological conditions such as Parkinson's disease, epilepsy, chronic pain, and severe depression. This technology aims to regulate neural function by stimulating specific areas of the brain using electrical signals.

[0004] However, conventional deep brain stimulators can only stimulate limited locations, and the effectiveness of stimulation may decrease if the electrode position is inaccurate or changes over time. As shown in the left figure of Fig. 1, when attempting to stimulate various brain regions, two or more neural electrode tips must be inserted, and stimulation is possible only at the tips of the electrodes.

[0005] With these existing deep brain stimulators, there is a high risk of unwanted side effects when stimulating the central nervous system, such as the brain and spinal cord, where areas with various functions are densely concentrated. Furthermore, there are still limitations in ex vivo stimulation for localized stimulation of desired areas within a few millimeters. In addition, implantable devices require surgical intervention, and if there is an abnormality (damage, displacement of stimulation location, etc.) in the implantable interface, secondary or tertiary re-surgery is required, which can place a high physical and economic burden on the patient.

[0006] To solve these problems, the inventors have completed the present invention, which allows for the expectation of a more ideal therapeutic effect by simultaneously stimulating various parts of the brain (cerebral cortex, hippocampus, hypothalamus, etc.) in a novel manner that penetrates the skull with minimal damage using electrodes finely fabricated with MEMS technology.

[0007]

[0008] One aspect of the present invention aims to provide a cranial penetrating neuroflexible electrode comprising: a front portion having a needle hole; an electrode portion comprising one or more of a circuit, a circuit and an electrode, and a neuroregeneration inducing electrode; and a terminal portion comprising a circuit connection pad.

[0009]

[0010] One aspect of the present invention provides a cranial penetrating neuroflexible electrode comprising: a front portion having a needle hole; an electrode portion comprising one or more of a circuit, a circuit and an electrode, and a neuroregeneration inducing electrode; and a terminal portion comprising a circuit connection pad.

[0011]

[0012] The penetrating neural flexible electrode of the present invention is inserted from one side of the head, penetrates a target area, and exits through the opposite side of the head. Since the electrode ends implanted on both sides of the skull are fixed, the positional movement of the electrode is restricted, enabling stable stimulation at an accurate location for a long period. Furthermore, by deploying multiple electrodes capable of stimulation, it is possible to analyze neural signals and provide electrical stimulation in various regions through a single implantation, ranging from the outer part of the brain, the cortex, to deep regions such as the thalamus and hippocampus.

[0013] Furthermore, by applying the technology of this invention to the closed-loop control system of an implantable medical device currently under development, it is possible to treat diseases such as epilepsy and seizures by identifying abnormal signals within the brain region more quickly. In addition, it can be of great assistance to various brain science studies, and by establishing a database based on various diseases and stimulation characteristics, it is expected to lay the foundation for the treatment of intractable neurological diseases using electronic medicine.

[0014]

[0015] Figure 1 shows the structure of a penetrating deep stimulator compared to a conventional deep brain stimulator.

[0016] Figure 2 is a figure showing the structure of the penetrating neuroflexible electrode of the present invention.

[0017] FIG. 3 is a flowchart illustrating a method for manufacturing a penetrating neuroflexible electrode of the present invention.

[0018] FIG. 4 is a figure showing equipment used for installing the penetrating neuroflexible electrode of the present invention.

[0019] Figure 5 is a diagram showing the installation process of the penetrating neuroflexible electrode of the present invention.

[0020] Figure 6 is a figure illustrating a surrounding brain nerve area penetrated by the penetrating neuroflexible electrode of the present invention.

[0021]

[0022] One aspect of the present invention provides a cranial penetrating neuroflexible electrode comprising: a front portion having a needle hole; an electrode portion comprising one or more of a circuit, an electrode, and a neuroregeneration inducing electrode; and a terminal portion comprising a circuit connection pad.

[0023] In one embodiment of the present invention, the nerve induction electrode may include a nerve induction hole.

[0024] In one embodiment of the present invention, the electrode portion may include a first dielectric layer (insulated layer), a conductive layer that transmits an electrical signal or stimulus, and a second dielectric layer (insulated layer).

[0025] In one embodiment of the present invention, the circuit connection pad of the terminal portion may be provided with the first dielectric layer, the conductive layer, and the second dielectric layer of the electrode portion extended therefrom.

[0026] In one embodiment of the present invention, the terminal portion may be located on the outside of the head without penetrating the skull, so as to transmit external stimuli into the skull or transmit stimuli within the skull to the outside.

[0027]

[0028] One or more embodiments are described in detail below with reference to the drawings. However, these embodiments are intended to illustrate one or more embodiments and the scope of the present invention is not limited to these embodiments.

[0029]

[0030] FIG. 1 shows the structure of a penetrating deep stimulator compared to a conventional deep brain stimulator, and flowcharts showing the structure and manufacturing method of the penetrating neuroflexible electrode of the present invention are shown in FIG. 2 and 3, respectively. The equipment used and the installation process related to the installation of the penetrating neuroflexible electrode of the present invention are shown in FIG. 4 and 5, respectively.

[0031] Figure 6 is a figure illustrating a surrounding brain nerve area penetrated by the penetrating neuroflexible electrode of the present invention.

[0032]

[0033] In order to overcome the problems of conventional deep brain stimulators as shown in Fig. 1, the inventors devised a neural interface method that is inserted from one side of the head, penetrates a target area, and exits through the opposite side of the head. This method has the advantage that electrode ends implanted on both sides of the skull are fixed to limit the positional movement of the electrodes, thereby enabling stable stimulation at an accurate location for a long period of time, and allows for the placement of multiple stimulating electrodes, thereby enabling neural signal analysis and electrical stimulation in various regions through a single implantation, ranging from the outer part of the brain, the cortex, to the deep regions, the thalamus and hippocampus.

[0034] The present invention is a new type of neural interface technology that penetrates the brain and implants a system circuit connected thereto, which has a narrow and long shape with a plurality of electrode arrays on a flexible substrate material (Fig. 2) and allows for the measurement / stimulation of various areas with a single insertion (Fig. 4).

[0035] FIG. 2 illustrates a flexible neural electrode structure of the present invention. Referring to FIG. 2, the structure has a planar shape with a narrow width and thickness and is long and thin, with a cross-sectional area minimized to penetrate the brain. It is composed of a front portion having a hole for connecting a thread to the flexible electrode, an electrode portion for measuring neural signals and electrical stimulation, and a terminal portion for connecting to a circuit portion. The space between the electrode portion and the terminal portion may be extended as needed and may have a serpentine shape.

[0036] One aspect of the cranial penetrating neuroflexible electrode of the present invention may comprise a front portion having a needle hole; an electrode portion comprising one or more of a circuit, an electrode, and a neuroregeneration inducing electrode; and a terminal portion comprising a circuit connection pad.

[0037] The above-mentioned shear section is connected to the electrode section and is equipped with a needle hole, and is configured to be inserted first for skull penetration. Therefore, a certain level of strength is required, and to achieve the purpose, it may be made of a known material and shape, but may be made of a tapered shape.

[0038] Unlike the electrode portion described later, the above-mentioned front portion does not have an electrode or a nerve regeneration-inducing electrode, but is provided with a needle hole (the 'hole for tying thread' in FIG. 1), and when installing the cranial-penetrating flexible nerve electrode of the present invention, it can be penetrated and removed or remain partially outside the skull for fixation ( FIGs. 2 and 4).

[0039] The above needle hole is used when installing the neuroflexible electrode of the present invention as described above. It can be used in the process of penetrating a target area within the skull with a penetrating guide (Fig. 4), connecting the needle hole provided at one end of the penetrating guide with the needle hole at the front end of the neuroflexible electrode of the present invention, and then pulling out the penetrating guide so that the neuroflexible electrode of the present invention follows and settles and fixes in the target area (Fig. 5).

[0040] The electrode portion described above is configured to include one or more of a circuit, an electrode, and a nerve regeneration-inducing electrode, and is located between the front portion and the terminal portion. The electrode portion has a circuit made of a conductive material formed along the longitudinal direction, and an electrode formed extending in one direction connected to the circuit, or a nerve regeneration-inducing electrode further including a nerve regeneration-inducing hole inside the electrode, is formed. In this case, depending on the purpose, only one type of electrode or nerve regeneration-inducing electrode may be formed, or both may be included. If both an electrode and a nerve regeneration-inducing electrode are included, their arrangement or order may be consistent with the purpose, and there are no restrictions thereon.

[0041] The above circuit is made of a conductive material and can transmit a signal entering the electrode or nerve regeneration induction electrode toward the terminal portion, or transmit an electrical signal generated at the terminal portion to the electrode or nerve regeneration induction electrode. The above circuit may be formed in multiple numbers, and as an example, a number of circuits corresponding to each electrode and nerve regeneration induction electrode may be formed.

[0042] The above electrode is made of a conductive material such as a circuit and can function to measure (receive) electrical signals generated at a target area where the flexible electrode of the present invention is installed, or to stimulate (apply) electrical signals to the target area.

[0043] The aforementioned nerve regeneration-inducing electrode can also be made of a conductive material in addition to the nerve regeneration-inducing hole and perform a function similar to an electrode. Furthermore, the nerve regeneration-inducing electrode can perform the function of nerve regeneration through the nerve regeneration-inducing hole.

[0044] Nerve regeneration can be aided by applying or coating a drug (Nerve growth factor) capable of inducing nerve regeneration inside the above-mentioned nerve regeneration induction hole.

[0045] Through the above electrode portion, electrical stimulation can be applied or received at a target point within the skull where the neuro-flexible electrode of the present invention is installed, and nerve regeneration can be induced.

[0046] In one embodiment of the present invention, the electrode portion may comprise a first dielectric layer (insulated layer), a conductive layer that transmits an electrical signal or stimulus, and a second dielectric layer (insulated layer). Specifically, the electrode portion may comprise a first dielectric layer on one surface, a conductive layer formed on part or all of the first dielectric layer, and a second dielectric layer formed on one or more of the first dielectric layer, between the conductive layers, and part or all of the conductive layer.

[0047] The first dielectric layer above forms the base layer (substrate) of the neural flexible electrode of the present invention, and unlike the conductive layer, it can be made of a polymer-based material such as polyimide, parylene, silicone, epoxy, and PDMA.

[0048] The conductive layer described above is a layer through which electrical signals are transmitted, forming the aforementioned circuit, electrode, or nerve-induced regenerative electrode, and can be fabricated by including a metal, a conductive polymer which is any one of polyaniline, polypyrrole, polythiophene, and PEDOT (poly(3,4-ethylenedioxythiophene)), or a nanomaterial such as CNT (Carbon nanotube), Graphene, Carbon black, or MXene.

[0049] The second dielectric layer is intended for separating and protecting the conductive layer. When a plurality of conductive layers are formed on the first dielectric layer, the second dielectric layer is formed between the conductive layers to separate the plurality of conductive layers, and can also be formed on the first dielectric layer or on the conductive layer to protect the conductive layer from the outside. The second dielectric layer can be made of a polymer-based material such as polyimide, parylene, silicone, epoxy, and PDMA, and, as an example, can be made of the same material as the first dielectric layer.

[0050] FIG. 3 is a flowchart illustrating a method for manufacturing a flexible electrode. As an example of the present invention, a micro-sized electrode can be constructed by applying MEMS (Micro Electro Mechanical Systems) technology, and can be fabricated by depositing a metal layer on a flat substrate such as a Si wafer so that the electrode to be processed can be later removed by etching.

[0051] The above terminal portion is provided connected to the electrode portion and includes a circuit connection pad, and the circuit connection pad of the terminal portion may be provided with an extension of a first dielectric layer, a conductive layer, and a second dielectric layer. Although the circuit connection pad has an extension of the first dielectric layer, a conductive layer, and a second dielectric layer, the shape, length, thickness, etc., of the first dielectric layer, the conductive layer, and the second dielectric layer may vary depending on the purpose. In particular, if there is a device coupled to the terminal portion, the first dielectric layer, the conductive layer, and the second dielectric layer of the circuit connection pad may be configured according to the specifications or characteristics of the coupling portion provided by the device.

[0052] In one embodiment of the present invention, the terminal portion may be located on the outside of the head without penetrating the skull, so as to transmit external stimuli into the skull or transmit stimuli within the skull to the outside.

[0053] As described above, the neuroflexible electrode of the present invention is installed by penetrating the skull, but the terminal portion can be fixed by being located on the outside of the head without penetrating, and the terminal portion fixed on the outside can be combined with an external device to give a signal to the electrode of the electrode portion to provide electrical stimulation to a target area, or receive electrical stimulation from the target area and measure a signal.

[0054] The installation of the neuroflexible electrode of the present invention is as shown in FIGS. 4 and 5. Specifically, since the guide for penetrating the brain must create a path by piercing the brain tissue, a material such as metal or other rigid materials may be selected. It is preferable to manufacture the guide to have a cross-sectional area similar to that of the neuroflexible electrode of the present invention. After selecting the area to be penetrated based on anatomical data, the skull is perforated at the part where the guide will enter and exit. After penetrating the guide through a stereotactic frame, the hole at the opposite end of the guide is connected to the end hole of the flexible electrode with a thread, and then the guide is pulled out again to position the flexible electrode connected by the thread into the brain. Afterward, the perforated part is sealed, and the circuit part can also be fixed and installed on the skull. Subsequently, the skull perforation is sealed using a biocompatible material (medical resin, epoxy, cement, etc.), thereby minimizing the displacement of the flexible electrode. In this case, the neuroflexible electrode can be used for a long period of time. In addition, the system circuit connected to the tip of the flexible electrode can be attached to the skull depending on the volume or positioned on the chest by connecting additional extension lines, thereby reducing patient discomfort or improving aesthetics.

[0055] Figure 6 illustrates an example of a surrounding brain neural region penetrated by the neuroflexible electrode of the present invention. As shown in the figure presented in Figure 6, brain diseases manifest due to abnormalities in various parts of the brain or therapeutic effects are observed through stimulation, and even for the same disease, abnormalities appear in multiple regions. Through a single insertion, stimulation and measurement of various regions, from the outer cortex to the deep regions of the brain, are possible.

[0056]

[0057] The present invention has been described above with reference to its preferred embodiments. Those skilled in the art will understand that the present invention may be embodied in modified forms without departing from the essential characteristics of the invention. Therefore, the disclosed embodiments should be considered in an illustrative rather than a restrictive sense. The scope of the invention is defined by the claims, not by the foregoing description, and all variations within the scope of the claims should be interpreted as being included in the invention.

Claims

1. A shear section equipped with a needle hole; An electrode portion comprising one or more of a circuit, an electrode, and a nerve regeneration inducing electrode; and A terminal section including a circuit connection pad Cranial penetrating nerve flexible electrode.

2. In Paragraph 1, The above-mentioned nerve induction electrode is a cranial penetrating nerve flexible electrode that includes a nerve induction hole.

3. In Paragraph 1, The above electrode portion comprises a first dielectric layer (insulated layer), a conductive layer that transmits electrical signals or stimuli, and a second dielectric layer (insulated layer), forming a cranial penetrating neural flexible electrode.

4. In Paragraph 1, A cranial penetrating neural flexible electrode in which the circuit connection pad of the terminal portion is provided with the first dielectric layer, conductive layer, and second dielectric layer of the electrode portion extended therefrom.

5. In Paragraph 1, A craniofacial penetrating nerve flexible electrode in which the terminal portion is located on the outside of the head without penetrating the skull, thereby transmitting external stimuli into the skull or transmitting internal stimuli to the outside.

Images