CN117942493A - Implantable multi-layer electrode structure and implantable electrode device - Google Patents

Abstract

The present disclosure provides an implantable multi-layered electrode structure and an implantable electrode device for implanting into a target region of a target object and generating an electric field or current to inhibit growth of target cells of the target region or induce apoptosis of target cells of the target region, wherein the multi-layered electrode structure includes a wire, a first electrode layer, and a second electrode layer coating the first electrode layer, at least one of the first electrode layer and the second electrode layer being connected to the wire to receive a preset electric signal and generate the electric field. Through the implanted multi-layer electrode structure or the implanted electrode device, the electric field or the current generated by the electric signals in the middle and low frequency ranges can be utilized to inhibit the growth of target cells or induce the apoptosis of the target cells, and meanwhile, the problem of space occupation when a plurality of electrode forms are implanted into a target area can be solved.

Description

Implantable multi-layer electrode structure and implantable electrode device

Technical Field

The present disclosure relates generally to the field of medical devices, and more particularly to an implantable multi-layer electrode structure and implantable electrode device.

Background

With the advancement of medical technology, an emerging Tumor treatment method, namely Tumor electric field therapy (Tumor TREATING FIELDS, TTF), is proposed, and the action mechanism is as follows: an alternating electric field with low intensity and medium frequency (100-300 kHz) is applied to subcellular structures such as tubulin of proliferation cancer cells to interfere with the mitosis of tumor cells, so that the cancer cells are apoptotic and the growth of tumors is inhibited. Therefore, devices have been developed which inhibit the growth of tumor cells by an alternating electric field based on tumor electric field therapy, thereby achieving treatment of tumor cells. Such as patent application CN 101553180B, which provides an apparatus and system and method for electric field delivery and non-thermal or selective ablation of a target tissue region, capable of applying an alternating current to the target tissue to non-thermally ablate cancer cells. For example, patent application CN 113694371A, which provides an implantable electrode and an electric field treatment device, a flexible electrode sheet and a flexible lead are adopted, and the implantable electrode can be adaptively deformed according to an implanted part when being implanted into a patient, so that the implantable electrode has good adaptability, and the implantable electrode can be suitable for different patients and different tumor treatments.

Recent studies have shown that the pulsed electric field at low frequency (0-500 Hz) also has the effect of killing tumor cells, with a frequency range of 50-200Hz, and it is notable that the main killing mechanism of TTF at medium frequency is inhibition of mitosis of tumor cells, while the main killing mechanism of TTF at low frequency is death and apoptosis of tumor cells. The two killing means and the chemotherapeutic drugs have better effect of inhibiting the growth of tumor cells compared with single use (TTF or chemotherapeutic drugs).

However, in the prior art, tumors are mostly treated by an intermediate frequency electric field, for example, 50kHz to 300kHz is used in the patent application with publication number CN 101553180B, 50kHz to 500kHz is used in the patent application with publication number CN 113694371a, and the low-frequency TTF electrode type and the use mode are not aimed at, so that the intermediate frequency TTF electrode has a single structure, a limited treatment mode and still has an improved treatment effect. In addition, because of a certain difference of TTF action mechanisms of the middle and low frequency bands, two general forms of electrodes are used for tumor treatment, the occupation of space is possibly increased, the occupying effect is caused, and the treatment of the tumor residual cavity implanted after operation is not facilitated.

Disclosure of Invention

The present disclosure has been made in view of the above-mentioned conventional art, and an object thereof is to provide an implantable multi-layered electrode structure and an implantable electrode device, which can inhibit the growth of target cells or induce apoptosis of target cells by generating an electric field or current using electric signals in a middle and low frequency band, and can solve the problem of space occupation when a plurality of electrode forms are implanted into a target region.

To this end, a first aspect of the present disclosure provides an implantable multi-layered electrode structure for being implanted to a target region of a target object and generating an electric field to inhibit growth of target cells of the target region or induce apoptosis of target cells of the target region, the multi-layered electrode structure including a wire, a first electrode layer, and a second electrode layer coating the first electrode layer, at least one of the first electrode layer and the second electrode layer being connected to the wire to receive a preset electric signal and generate the electric field. In this case, the first electrode layer is coated by the second electrode layer to form an electrode structure having two electrode forms, thereby being capable of inhibiting or inducing apoptosis of target cells by generating an electric field or current using electric signals of middle and low frequency bands, and solving the problem of space occupation when a plurality of electrode forms are implanted into a target region.

According to the multilayer electrode structure to which the present disclosure relates, optionally, the first electrode layer includes a first electric field generating contact having a conductive material and an insulating layer having an insulating material, the insulating layer being formed between the first electric field generating contact and the second electrode layer. In this case, since the first electrode layer is located inside the multi-layered electrode structure, when the multi-layered electrode structure is implanted into the target area, an insulating layer exists between the first electric field generating contact and the target cell, so that the first electric field generating contact can be regarded as an insulated electrode, and thus the target cell can be treated by a specific mechanism based on electric field parameters (such as frequency, electric field amplitude or electric signal waveform) that the insulated electrode design matches. Meanwhile, the insulating layer of the first electrode layer can isolate the first electric field generating contact from the second electrode layer, so that the first electric field generating contact and the second electrode layer are not affected by each other, and therefore, the first electrode layer and the second electrode layer can be in different working states, for example, the first electrode layer and the second electrode layer can generate electric fields with different frequencies, and therefore, the growth of target cells can be inhibited or apoptosis of the target cells can be induced in the electric fields or currents generated by using the medium-low frequency electric signals respectively.

According to the multilayer electrode structure to which the present disclosure relates, optionally, the second electrode layer includes a second electric field generating contact having a conductive material. In this case, since the second electrode layer is located outside the multi-layered electrode structure, when the multi-layered electrode structure is implanted in the target area, the second electric field generating contact is located closer to the target cell, and can generate an electric current with the target cell, so that the second electric field generating contact can be regarded as a conductor electrode, and thus, the target cell can be treated by a specific mechanism based on electric field parameters (such as frequency, electric field amplitude or electric signal waveform) matched with the conductor electrode design. For example, at least one of an electric field or an electric current can be generated by the second electric field generating contact using the electric signals of the middle and low frequency bands to inhibit the growth of the target cells or induce the apoptosis of the target cells.

According to the multilayer electrode structure to which the present disclosure relates, optionally, the second electrode layer includes a housing having a biocompatible material and at least one of the second electric field generating contacts embedded in the housing. In this case, the housing can support and protect the electrode structure, and at the same time, since the second electrode layer has biocompatibility, inflammation or rejection reaction generated when the target object is implanted can be reduced; in addition, the electric field can be formed at different positions or in different directions of the multi-layered electrode structure by at least one second electric field generating contact embedded in the housing.

According to the multilayer electrode structure to which the present disclosure relates, optionally, the first electrode layer includes at least one of the first electric field generating contacts, the number of the first electric field generating contacts is the same as the number of the second electric field generating contacts, and the positions of the first electric field generating contacts and the positions of the second electric field generating contacts are matched so that the second electric field generating contacts cover the first electric field generating contacts. In this case, since the first electric field generating contact and the second electric field generating contact each have a conductive material, and the position of the first electric field generating contact matches with the position of the second electric field generating contact, the problem of attenuation of the electric field generated by the first electric field generating contact can be reduced, and thus the first electric field generating contact and the second electric field generating contact can be made to operate independently without interfering with each other.

According to the multilayer electrode structure to which the present disclosure relates, optionally, the first electrode layer is formed with a cavity accommodating the wire. In this case, it can be convenient to apply a preset electrical signal to the electrode structure through the wire to form an electric field or current.

According to the multilayer electrode structure to which the present disclosure relates, optionally, the wire includes a first wire connected to the first electric field generating contact, the first wire being configured to transmit an electrical signal to the first electric field generating contact. In this case, the first electric field generating contact can be made to receive a preset electric signal and generate an electric field.

According to the multilayer electrode structure to which the present disclosure relates, optionally, the wire includes a second wire connected to the second electric field generating contact, the second wire being configured to transmit an electric signal to the second electric field generating contact. In this case, the second electric field generating contact can be made to receive a preset electric signal and generate an electric field or current.

According to the multilayer electrode structure to which the present disclosure relates, optionally, the first electric field generating contact is configured to generate an electric field to inhibit growth of target cells, and the second electric field generating contact is configured to generate an electric field to inhibit growth of target cells or induce apoptosis of target cells. In this case, the electric field or the electric current generated by the electric signal of the middle or low frequency band can be received by the first electric field generating contact or the second electric field generating contact to inhibit the growth of the target cell or induce the apoptosis of the target cell.

A second aspect of the present disclosure provides an implantable electrode device comprising a signal generating module, an electrode part and an electrode fixing part, the electrode part comprising the multi-layered electrode structure of any one of the first aspects of the present disclosure, the signal generating module being configured to provide a preset electrical signal to the electrode part, the electrode part being configured to be implanted into a target region of a target object and generate an electric field to inhibit growth of target cells of the target region or induce apoptosis of target cells of the target region, the electrode fixing part being configured to fix the electrode part to the target region of the target object. Under the condition, the implanted electrode device can utilize electric fields or currents generated by the medium-frequency and low-frequency electric signals to inhibit the growth of target cells or induce the apoptosis of the target cells, and can solve the problem of space occupation when a plurality of electrode forms are implanted into a target area.

According to the present disclosure, an implantable multi-layered electrode structure and an implantable electrode device can be provided, which can inhibit the growth of target cells or induce apoptosis of target cells by generating an electric field or current using middle and low frequency band electric signals, and can solve the space occupation problem when a plurality of electrode forms are implanted into a target region.

Drawings

Fig. 1 is a schematic view showing an application scenario of an implantable multi-layered electrode structure or an electrode device according to an embodiment of the present disclosure.

Fig. 2a is a schematic diagram illustrating a patient's head in accordance with embodiments of the present disclosure. Fig. 2b is a schematic diagram illustrating a patient's head after removal of tumor tissue in accordance with embodiments of the present disclosure.

Fig. 3 is a schematic diagram illustrating an implantable multi-layered electrode structure or electrode device according to an embodiment of the present disclosure.

Fig. 4 is a schematic cross-sectional structure of example 1 showing an implantable multilayer electrode structure according to an embodiment of the present disclosure.

Fig. 5 is a schematic cross-sectional structure of example 2 showing an implantable multilayer electrode structure according to an embodiment of the present disclosure.

Fig. 6 is a schematic cross-sectional structure of example 3 showing an implantable multilayer electrode structure according to an embodiment of the present disclosure.

Fig. 7 is an external view schematically showing example 3 of an implantable multilayer electrode structure according to an embodiment of the present disclosure.

Fig. 8 is an external view schematically showing other examples of an implantable multilayer electrode structure according to an embodiment of the present disclosure.

Fig. 9 is a schematic view illustrating a structure of one of the implantable electrode devices according to the embodiment of the present disclosure.

Reference numerals illustrate:

1 … … target, 11 … … target region, 12 … … tumor tissue, 13 … … brain tissue, 14 … … skull,

2 … … Electrode assembly, 21 … … signal generating module, 22 … … electrode portion, 23 … … electrode fixing portion, 220 … … multilayer electrode structure, 221 … … first electrode layer, 2211 … … first electric field generating contact, 2212 … … insulating layer, 2213 … … cavity, 222 … … second electrode layer, 2221 … … second electric field generating contact, 2222 … … housing, 223 … … wire, 2231 … … first wire, 2232 … … second wire.

Detailed Description

The following description of the technical solutions in the embodiments of the present disclosure will be made clearly and completely with reference to the accompanying drawings in the embodiments of the present disclosure, and it is apparent that the described embodiments are only some embodiments of the present disclosure, not all embodiments. All other embodiments, which are filled by those of ordinary skill in the art without undue burden based on the embodiments in this disclosure, are within the scope of the present disclosure.

It should be noted that the terms "first," "second," "third," and "fourth," etc. in the description and claims of the present disclosure and in the above figures are used for distinguishing between different objects and not for describing a particular sequential order. Furthermore, the terms "comprise" and "have," as well as any variations thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, system, article, or apparatus that comprises a list of steps or elements is not limited to only those listed or inherent to such process, method, article, or apparatus but may optionally include other steps or elements not listed. In the following description, the same members are denoted by the same reference numerals, and overlapping description thereof is omitted. In addition, the drawings are schematic, and the ratio of the sizes of the components to each other, the shapes of the components, and the like may be different from actual ones.

The tumor treating electric field is one low-strength medium frequency (100-300 kHz) alternating electric field and can prevent spindle microtubule from forming and cell organelle from separating during mitosis of some tumor cells to induce mitosis cell apoptosis and treat tumor. Some physiological properties of tumor cells, such as geometry and high frequency mitosis, make them susceptible to TTF. According to the current research, the killing effect of the intermediate frequency electric field mainly comprises two aspects: post-mitotic dependent dielectrophoretic killing and post-mitotic independent dipole stress killing. However, in some experimental data it was found that the killing effect of low frequency (below 1000 Hz) electric fields for treatment of tumors is mainly responsible for death and apoptosis of tumor cells, and for an increase in cells in the G0 phase (G0 phase refers to the period of time in which cells in a tissue with dividing ability temporarily leave the cell cycle and enter into the stop of cell division) whereas the medium frequency causes an increase in cells in the G2/M phase (i.e. the later stage of DNA synthesis, also called "mitotic preparation phase", mainly prepared for the later M phase). Since the G0 phase is a phase in which the cells temporarily stop mitosis, it is considered that the killing effect at low frequency is such that the cells do not enter into the mitosis cycle, while the killing effect at intermediate frequency is such that the cells cannot normally complete mitosis.

In TTF, one electrode can be used to inhibit spindle formation (by affecting tubulin arrangement) and cell membrane foaming at the later stages of division (dielectrophoresis) and to interfere with mitosis in both ways, and another electrode can be used to cause death and apoptosis of tumor cells. One of the main differences between the two electrodes is whether there is an electron flow around the cell, the latter will have an electron flow (i.e. current) between the electrodes, while there is only an induced current between the former, whereas there is no significant difference between the two electrodes in terms of the electric field. It was found that the latter mediated electron flow may interfere with ion channels on the cell membrane surface, and that the electron flow may also produce more pronounced thermal effects, thereby causing other killing effects. In general, the former electrode may be referred to as an insulated electrode, and the latter electrode may be referred to as a conductor electrode.

Since the above two electrodes have different mechanisms for killing tumor cells, respectively, and it is not clear whether it can be used as an electrode for treating tumors by a low frequency electric field. Therefore, the present disclosure provides an implantable multi-layered electrode structure and an implantable electrode device, which can inhibit the growth of target cells or induce apoptosis of target cells by generating an electric field or current using middle and low frequency electric signals, and can solve the space occupation problem when a plurality of electrode forms are implanted into a target region. In some examples, the multi-layer electrode structure may also be referred to as a "double-layer electrode structure" because the current approach employs a double-layer electrode system. In some examples, the multi-layer electrode structure may not clearly distinguish between the interlayer structures, and thus the multi-layer electrode structure may also be referred to as a "multi-electrode structure" or an "electrode structure of multiple electrodes". For convenience of description below, the implantable multi-layered electrode structure and the implantable electrode device according to the present disclosure may be sometimes simply referred to as an "electrode structure" and an "electrode device", and it is understood that the "electrode structure" and the "electrode device" according to the present disclosure are the foregoing implantable multi-layered electrode structure and the implantable electrode device unless otherwise indicated.

In order to better describe the advantageous effects of the multilayer electrode structure or the electrode device according to the present disclosure compared to the prior art, the following description is first made by illustrating the application scenario of the electrode structure or the electrode device according to the embodiment of the present disclosure. Fig. 1 is a schematic view showing an application scenario of an implantable multi-layer electrode structure 220 or an electrode device 2 according to an embodiment of the present disclosure. Fig. 2a is a schematic diagram illustrating a patient's head in accordance with embodiments of the present disclosure. Fig. 2b is a schematic diagram illustrating the head of a patient after removal of tumor tissue 12 in accordance with an embodiment of the present disclosure.

In some examples, referring to fig. 1, embodiments of the present disclosure relate to an implantable multi-layer electrode structure or electrode device 2 that may be implanted into a target region 11 of a target object 1. The implanted multi-layer electrode structure 220 or electrode device 2 may also be referred to as multi-layer electrode structure 220 or electrode device 2 hereinafter.

In some examples, the target object 1 may be an animal. In some examples, the target object 1 may be a person. In some examples, the target object 1 may be a patient with tumor tissue 12. In some examples, referring to fig. 1, the target object 1 may be a patient with an intracranial tumor. It should be noted that the implantable multi-layer electrode structure 220 or the electrode device 2 according to the present disclosure may be implanted in the vicinity of the tumor tissue 12, and the tumor may include, but is not limited to, gastric tumor, brain tumor, lung tumor, and liver tumor. The multi-layered electrode structure 220 or the electrode device 2 will be described below by taking glioma as an example.

In some examples, the target region 11 may be located intracranially. In some examples, referring to fig. 2a, a brain glioma patient's head may include: skin, skull 14, cerebrospinal fluid, brain tissue 13 and tumor tissue 12. In some examples, tumor tissue 12 may be resected using surgery.

In some examples, referring to fig. 2b, after removal of tumor tissue 12, a cavity may be formed within brain tissue 13. In this case, the head of the glioma patient after removal of the tumor tissue 12 may include: skin, skull 14, cerebrospinal fluid, brain tissue 13 and cavities. In some examples, the target region 11 is a cavity that may refer to after removal of tumor tissue 12.

Due to the limitations of current procedures, there is no guarantee that there are no tumor cells left behind on the inner wall of the target area 11 after the tumor tissue 12 has been surgically removed. In this case, after the implanted multilayer electrode structure 220 or the electrode device 2 according to the present disclosure is implanted in the target region 11 of the target object 1, the growth of tumor cells in the vicinity of the inner wall can be suppressed by the electric field formed by the multilayer electrode structure 220 or the electrode device 2. In other words, the target cell may refer to a tumor cell located near the inner wall.

However, the present disclosure is not limited thereto, and the implantable multi-layer electrode structure 220 or the electrode device 2 according to the present disclosure can also be implanted near the tumor tissue 12 before the tumor tissue 12 is resected, and an electric field is formed near the tumor tissue 12 to treat tumor cells (or the tumor tissue 12).

Treatment of tumor cells (or tumor tissue 12) may be referred to as inhibiting the growth of tumor cells near the inner wall. For example, treatment of a tumor cell (or tumor tissue 12) may refer to the application of an alternating electric field of a specific frequency to the tumor cell to inhibit mitosis of the tumor cell, treatment of a tumor cell (or tumor tissue 12) may refer to the application of an alternating electric field of a specific frequency to the tumor cell to cause death and apoptosis of the tumor cell and thereby kill the tumor cell, and treatment of a tumor cell (or tumor tissue 12) may refer to the application of an alternating electric field in combination with other tumor treatment methods such as chemotherapy, radiation therapy, or drugs to enhance the efficacy of the corresponding treatment methods.

The following is a schematic description of the structure or method of use of the implantable multilayer electrode structure 220 or electrode device 2 in accordance with embodiments of the present disclosure, and it is to be noted that the following embodiments are intended to illustrate and not limit the multilayer electrode structure 220 or electrode device 2 of the present disclosure.

Fig. 3 is a schematic diagram illustrating an implantable multi-layer electrode structure 220 or an electrode device 2 according to an embodiment of the present disclosure.

In some examples, referring to fig. 3, the multi-layer electrode structure 220 or the electrode device 2 may be the multi-layer electrode structure 220 or the electrode device 2 that generates an electric field and inhibits growth of target cells of the target region 11 using the electric field. In this case, after the implanted multi-layer electrode structure 220 or electrode device 2 is implanted into the target region 11, an electric field can be formed near the target region 11, and thus treatment of target cells can be achieved, and meanwhile, since the treatment effect on target cells and the electric field intensity in the environment where the target cells are located are positively correlated, if the multi-layer electrode structure 220 or electrode device 2 is disposed outside the cranium, skin, cranium 14, cerebrospinal fluid, and brain tissue 13 all cause redistribution of the electric field and reduce the intensity of the electric field, the energy loss of the multi-layer electrode structure 220 or electrode device 2 can be greatly improved, and therefore, the energy utilization efficiency of the multi-layer electrode structure 220 or electrode device 2 can be effectively improved, the intensity of the electric field can be improved, the service cycle of the multi-layer electrode structure 220 or electrode device 2 can be prolonged, and thus the daily life effect on the multi-layer electrode structure 220 or electrode device 2 of the target object 1 can be reduced, the compliance of the multi-layer electrode structure 220 or electrode device 2 can be improved, and the time coverage of the multi-layer electrode structure 220 or electrode device 2 can be improved, and the treatment effect on tumors can be improved by improving.

The details of the implantable multi-layer electrode structure 220 and implantable electrode device 2 related to the present disclosure, including but not limited to, structure, principles, and functional roles, are described in detail below in connection with various embodiments. Fig. 4 is a schematic cross-sectional structure diagram of example 1 showing an implantable multi-layer electrode structure 220 according to an embodiment of the present disclosure. Fig. 5 is a schematic cross-sectional structure diagram of example 2 showing an implantable multi-layer electrode structure 220 according to an embodiment of the present disclosure. Fig. 6 is a schematic cross-sectional structure diagram of example 3 showing an implantable multi-layer electrode structure 220 according to an embodiment of the present disclosure. Fig. 7 is an external view schematically showing example 3 of an implantable multi-layer electrode structure 220 according to an embodiment of the present disclosure. Fig. 8 is an external schematic view showing other examples of the implantable multilayer electrode structure 220 according to the embodiment of the present disclosure.

The first aspect of the present disclosure provides an implantable multi-layered electrode structure 220 for implantation into a target area 11 of a target object 1 and generating an electric field to inhibit target cell growth of the target area 11 or induce target cell apoptosis of the target area 11.

As shown in fig. 4, in some examples, the multi-layer electrode structure 220 may include a wire 223, a first electrode layer 221, and a second electrode layer 222 encasing the first electrode layer 221. In some examples, at least one of the first electrode layer 221 and the second electrode layer 222 may be connected with a wire 223 to receive a preset electrical signal and generate an electric field. As shown in fig. 5 and 6, in some examples, the coating may be divided into a complete coating and a partial coating, for example, the second electrode layer 222 as a whole directly and completely coats the first electrode layer 221, and the second electrode layer 222 may also be formed of multiple parts and form a monolithic structure similar to a network or skeleton from the multiple parts, thereby coating the first electrode layer 221. In this case, the first electrode layer 221 is coated by the second electrode layer 222 to form the multi-layered electrode structure 220 having two electrode forms, whereby the growth of the target cells can be suppressed or the apoptosis of the target cells can be induced by generating an electric field or current using the electric signals of the middle and low frequency bands, and the space occupation problem when the multiple electrode forms are implanted into the target region 11 can be solved.

In some examples, the multi-layer electrode structure 220 may generate an electric field, for example, when the multi-layer electrode structure 220 is isolated from a target cell or solute of the target region 11 using an insulating material. In some examples, the multi-layer electrode structure 220 may generate an electrical current, e.g., capable of forming a current loop when the multi-layer electrode structure 220 is in contact with a target cell or solute of the target zone 11. In some examples, the first electrode layer 221 may be insulated from a target cell or solute of the target region 11 by an insulating material. In some examples, the second electrode layer 222 may be capable of both generating an electric field and forming a current loop when in contact with a target cell or solute of the target region 11. In this case, an electric field or current can be generated by applying an electric signal of middle and low frequency band to the first electrode layer 221 or the second electrode layer 222, thereby inhibiting the growth of the target cell or inducing apoptosis of the target cell.

In some examples, the first electrode layer 221 and the second electrode layer 222 may generate electric fields of different strengths. For example, the first electrode layer 221 may generate an electric field having a strength greater than that of the second electrode layer 222, in which case, even if the first electrode layer 221 is located inside the second electrode layer 222, it can form an electric field having a strength that can inhibit the growth of a target cell or induce apoptosis of the target cell. In some examples, the first electrode layer 221 and the second electrode layer 222 may generate electric fields of different waveforms. For example, the first electrode layer 221 may generate an intermediate frequency electric field using an intermediate frequency electric signal, the second electrode layer 222 may generate a low frequency electric field using a low frequency electric signal, and waveforms are different due to the difference in frequency of the two electric fields, in which case the first electrode layer 221 and the second electrode layer 222 can be made to operate independently without affecting each other, thereby enabling the multi-layered electrode structure 220 to be improved in versatility.

As shown in fig. 4, 5, or 6, in some examples, the first electrode layer 221 may include a first electric field generating contact 2211 and an insulating layer 2212. In some examples, the first electric field generating contact 2211 may have a conductive material and the insulating layer 2212 may have an insulating material. In some examples, an insulating layer 2212 may be formed between the first electric field generating contact 2211 and the second electrode layer 222. In this case, since the first electrode layer 221 is located inside the multi-layered electrode structure 220, when the multi-layered electrode structure 220 is implanted into the target area 11, the insulating layer 2212 exists between the first electric field generating contact 2211 and the target cell, so that the first electric field generating contact 2211 can be regarded as an insulated electrode (i.e., an electrode between which no electron flow is formed), and thus the target cell can be treated by a specific mechanism based on electric field parameters (e.g., frequency, electric field amplitude, or electric signal waveform) matched with the insulated electrode design. Meanwhile, the insulating layer 2212 of the first electrode layer 221 can isolate the first electric field generating contact 2211 and the second electrode layer 222, so that the first electric field generating contact 2211 and the second electrode layer 222 are not affected by each other, and therefore the first electrode layer 221 and the second electrode layer 222 can be in different working states, for example, the first electrode layer 221 and the second electrode layer 222 can generate electric fields with different frequencies, and growth of target cells can be inhibited or apoptosis of the target cells can be induced in the electric fields or currents generated by using the medium-low frequency electric signals respectively.

In some examples, the first electric field generating contact 2211 conductive material may be at least one of a metallic conductive material, graphite, or a high dielectric material, preferably the first electric field generating contact 2211 is a metallic conductive material, such as gold, silver, platinum, copper, or the like. In some examples, the insulating material of the insulating layer 2212 may be a polymer material, ceramic, silicon, or other non-metallic insulating material, or the like.

In some examples, the first electric field generating contact 2211 may be sheet-like, rectangular-like, spherical-like, or other block-like.

As shown in fig. 4, 5, or 6, in some examples, the second electrode layer 222 may include a second electric field generating contact 2221. In some examples, second electric field generating contact 2221 may have a conductive material. In this case, since the second electrode layer 222 is located outside the multi-layered electrode structure 220, when the multi-layered electrode structure 220 is implanted in the target area 11, the second electric field generating contact 2221 is closer to the target cell, and thus a current can be formed between the target cell and the second electric field generating contact 2221 can be regarded as a conductor electrode (i.e., an electrode between which an electron flow can be formed), and thus the target cell can be treated by a specific mechanism based on an electric field parameter (e.g., frequency, electric field amplitude, or electric signal waveform) that is matched with the conductor electrode design. For example, at least one of an electric field or an electric current can be generated by the second electric field generating contact 2221 using electric signals of middle and low frequency bands to inhibit the growth of the target cells or induce apoptosis of the target cells.

In some examples, the second electric field generating contact 2221 may contact the target cell after the multi-layer electrode structure 220 is implanted into the target region 11. In other examples, after the multi-layer electrode structure 220 is implanted in the target region 11, a conductive material may be disposed between the second electric field generating contact and the target cell, i.e., the exterior of the second electric field generating contact 2221 may have a conductive material, e.g., the exterior of the second electric field generating contact 2221 may be a housing 2222 of a high dielectric material. In this case, the plurality of second electric field generating contacts 2221 can form both an electric field and an electron flow.

In some examples, second electric field generating contact 2221 conductive material may be at least one of a metallic conductive material, graphite, or a high dielectric material, preferably second electric field generating contact 2221 is a metallic conductive material, such as gold, silver, platinum, copper, or the like.

As shown in fig. 4 or 6, in other examples, the second electrode layer 222 may include a housing 2222 and a second electric field generating contact 2221. In some examples, the housing 2222 may be of a biocompatible material, and the at least one second electric field generating contact 2221 may be embedded in the housing 2222. In this case, the case 2222 can support and protect the multi-layered electrode structure 220, and at the same time, can reduce inflammation or rejection reaction generated when implanting the target object due to the biocompatibility of the second electrode layer 222; in addition, an electric field can be formed at different positions or in different directions of the multi-layered electrode structure 220 by at least one second electric field generating contact 2221 embedded in the housing 2222. In other examples, the housing 2222 may cover all of the second electric field generating contacts 2221, and the housing 2222 may be a material having both biocompatibility and high dielectric properties, in which case the entire housing 2222 may be regarded as one electrode sheet or a protective film, and since each of the second electric field generating contacts 2221 is surrounded by the biocompatible housing 2222, the compatibility at the time of implantation is high, and the respective second electric field generating contacts 2221 can be protected.

In some examples, the biocompatible material of housing 2222 may include, but is not limited to, medical grade PVC and polyethylene, PEEK, polycarbonate, ultem PEI, polysulfone, polypropylene, and polyurethane.

As shown in fig. 7 or 8, in some examples, the second electric field generating contact 2221 may be located at an outer surface of the multi-layer electrode structure 220. In this case, the second electric field generating contact 2221 is capable of directly contacting the target cell or solute of the target area 11 to form an electric field or electron flow. In some examples, second electric field generating contact 2221 may be sheet-like, rectangular-like, spherical-like, or other block-like.

As shown in fig. 6, in some examples, the first electrode layer 221 may include at least one first electric field generating contact 2211. In some examples, the number of first electric field generating contacts 2211 may be the same as the number of second electric field generating contacts 2221. In some examples, the position of the first electric field generating contact 2211 may be matched to the position of the second electric field generating contact 2221 such that the second electric field generating contact 2221 covers the first electric field generating contact 2211. In this case, since the first electric field generating contact 2211 and the second electric field generating contact 2221 each have a conductive material, and the position of the first electric field generating contact 2211 matches the position of the second electric field generating contact 2221, the problem of attenuation of the electric field generated by the first electric field generating contact 2211 can be reduced, and thus the first electric field generating contact 2211 and the second electric field generating contact 2221 can be made to operate independently without interfering with each other.

In other examples, the number of first electric field generating contacts 2211 may be different from the number of second electric field generating contacts 2221. In some examples, housing 2222 may be a high dielectric constant material. In this case, since the number of the first electric field generating contacts 2211 may be different from the number of the second electric field generating contacts 2221, the positions of the first electric field generating contacts 2211 may be mismatched with the positions of the second electric field generating contacts 2221, and the electric field generated by the first electric field generating contacts 2211 may not be greatly attenuated by the second electric field generating contacts 2221 of the conductive material or the housing 2222 of the high dielectric constant material, thereby also reducing the problem of attenuation of the electric field generated by the first electric field generating contacts 2211 when the number is different or the positions are mismatched.

As shown in fig. 4, 5, or 6, in some examples, the first electrode layer 221 may be formed with a cavity 2213 accommodating the lead 223. In this case, it can be convenient to apply a preset electrical signal to the multi-layered electrode structure 220 through the lead 223 to form an electric field or current.

In some examples, the first electrode layer 221 may be a hollow cylinder, the interior cavity 2213 of which may house the lead 223. In some examples, the first electrode layer 221 may be a solid cylinder, and the wire 223 may be embedded inside the first electrode layer 221.

As shown in fig. 4, in some examples, the wires 223 may include a first wire 2231 connected to the first electric field generating contact 2211, and the first wire 2231 may transmit an electrical signal to the first electric field generating contact 2211. In this case, the first electric field generating contact 2211 can be made to receive a preset electric signal and generate an electric field.

As shown in fig. 4, in some examples, the wires 223 may include a second wire 2232 connected to the second electric field generating contact 2221, and the second wire 2232 may transmit an electrical signal to the second electric field generating contact 2221. In this case, the second electric field generating contact 2221 can be made to receive a preset electric signal and generate an electric field or current.

In some examples, the first electric field generating contact 2211 can generate an electric field to inhibit growth of the target cell, and the second electric field generating contact 2221 can generate an electric field to inhibit growth of the target cell or induce apoptosis of the target cell. In this case, the growth of the target cell can be inhibited or apoptosis of the target cell can be induced by generating an electric field or a current by receiving the electric signal of the middle and low frequency band at the first electric field generating contact 2211 or the second electric field generating contact 2221.

In some examples, the first electric field generating contact 2211 can receive the mid-frequency electric signal and generate the mid-frequency electric field to inhibit target cell growth, e.g., inhibit mitosis, synchronize the cell cycle to the G2/M phase, without significantly inducing apoptosis. In some examples, second electric field generating contact 2221 may receive and generate an intermediate or low frequency electric signal and may generate an intermediate or low frequency electric field and may contact target cells or solutes of target region 11 to generate an electric current, thereby inhibiting growth or inducing apoptosis of the target cells, e.g., the electric field generated by the intermediate frequency electric signal may induce cell death and apoptosis, the electric field generated by the low frequency electric signal may inhibit mitosis, synchronize the cell cycle to the G0 phase, and not significantly induce apoptosis.

In some examples, at least two of the plurality of multi-layer electrode structures 220 may cooperate to form an electric field or current. In this case, an electric field can be generated to inhibit the growth of the target cells or induce apoptosis of the target cells.

In some examples, at least two first electric field generating contacts 2211 in the plurality of multilayer electrode structures 220 may cooperate to form an electric field. In this case, an electric field can be generated to inhibit the growth of the target cells.

In some examples, at least one first electric field generating contact 2211 and at least one second electric field generating contact 2221 of the plurality of multilayer electrode structures 220 may cooperate to form an electric field. In this case, an electric field can be generated to inhibit the growth of the target cells.

In some examples, at least two second electric field generating contacts 2221 of the plurality of multi-layer electrode structures 220 may cooperate to form an electric field or current. In this case, an electric field can be generated to inhibit the growth of the target cells or induce apoptosis of the target cells.

Fig. 9 is a schematic view showing the structure of one of the implantable electrode devices 2 according to the embodiment of the present disclosure.

A second aspect of the present disclosure provides an implantable electrode device 2. As shown in fig. 9, in some examples, the electrode device 2 may include a signal generating module 21, an electrode portion 22, and an electrode fixing portion 23, and the electrode portion 22 may include a multi-layer electrode structure 220 of any of the first aspects of the present disclosure.

In some examples, the signal generation module 21 may be used to provide a preset electrical signal to the electrode portion 22. In some examples, the electrode portion 22 may be used to implant into the target region 11 of the target object 1 and generate an electric field to inhibit target cell growth of the target region 11 or induce target apoptosis of the target region 11. In some examples, the electrode fixing portion 23 may be used to fix the electrode portion 22 to the target region 11 of the target object 1. In this case, by the implanted electrode device 2, the electric field or current generated by the electric signals of the middle and low frequency bands can be used to inhibit the growth of the target cells or induce the apoptosis of the target cells, and the problem of space occupation when the electrode forms are implanted in the target region 11 can be solved.

In some examples, the electrode portion 22 may be deformed to contract or expand the electrode device 2 when implanted in the target region 11, thereby being able to adapt to the shape or size of the target region 11, improving the coverage of the electric field, and thus improving the effect of inhibiting the growth of the target cells or inducing apoptosis of the target cells.

In some examples, the signal generation module 21 may be connected to the electrode portion 22 by a wire 223. In this case, an intermediate-frequency or low-frequency electric signal can be transmitted from the signal generation module 21 to the multi-layered electrode structure 220 of the electrode part 22 through the lead 223, whereby the growth of the target cells can be suppressed or apoptosis of the target cells can be induced by generating an electric field or current using the intermediate-frequency or low-frequency electric signal.

In some examples, the frequency band of the intermediate frequency electrical signal may be between 50-500KHz and the strength of the generated electric field may be between 0.5-10V/cm. In some examples, the frequency band of the low frequency electrical signal may be between 50-200Hz and the strength of the generated electric field may be between 1-10V.

In some examples, the electrode fixing portion 23 may fix the electrode device 2 to the skull 14 of the target object 1. In this case, the electrode device 2 can be stably implanted in the target region 11 and stabilized therein, whereby the therapeutic effect of the electrode device 2 can be enhanced.

According to the present disclosure, an implantable multi-layered electrode structure 220 and an implantable electrode device 2 can be provided, which can inhibit the growth of target cells or induce apoptosis of target cells using an electric field or current generated by using electric signals of middle and low frequency bands, and can solve the space occupation problem when a plurality of electrode forms are implanted into a target region 11.

While the disclosure has been described in detail in connection with the drawings and examples, it is to be understood that the foregoing description is not intended to limit the disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as required without departing from the true spirit and scope of the disclosure, and such modifications and variations are within the scope of the disclosure.

Claims (10)

1. An implantable multi-layered electrode structure for implantation into a target area of a target object and generating an electric field to inhibit growth of target cells of the target area or induce apoptosis of target cells of the target area, wherein the multi-layered electrode structure comprises a wire, a first electrode layer, and a second electrode layer coating the first electrode layer, at least one of the first electrode layer and the second electrode layer being connected to the wire to receive a preset electric signal and generate an electric field.

2. The multilayer electrode structure according to claim 1, wherein,

The first electrode layer includes a first electric field generating contact having a conductive material and an insulating layer having an insulating material, the insulating layer being formed between the first electric field generating contact and the second electrode layer.

3. The multilayer electrode structure according to claim 2, wherein,

The second electrode layer includes a second electric field generating contact having a conductive material.

4. The multilayer electrode structure according to claim 3, wherein,

The second electrode layer includes a housing having a biocompatible material and at least one of the second electric field generating contacts embedded in the housing.

5. The multilayer electrode structure according to claim 4, wherein,

The first electrode layer comprises at least one first electric field generating contact, the number of the first electric field generating contacts is the same as that of the second electric field generating contacts, and the positions of the first electric field generating contacts are matched with those of the second electric field generating contacts so that the second electric field generating contacts cover the first electric field generating contacts.

6. The multilayer electrode structure according to claim 1, wherein,

The first electrode layer is formed with a cavity accommodating the wire.

7. The multilayer electrode structure according to claim 2, wherein,

The wire includes a first wire connected to the first electric field generating contact, the first wire configured to transmit an electrical signal to the first electric field generating contact.

8. The multilayer electrode structure according to claim 4, wherein,

The wires include a second wire connected to the second electric field generating contact, the second wire configured to transmit an electrical signal to the second electric field generating contact.

9. The multilayer electrode structure according to claim 4, wherein,

The first electric field generating contact is configured to generate an electric field to inhibit growth of a target cell, and the second electric field generating contact is configured to generate an electric field to inhibit growth of the target cell or induce apoptosis of the target cell.

10. An implantable electrode device comprising a signal generating module for providing a preset electrical signal to an electrode portion for implantation into a target region of a target object and generating an electric field to inhibit growth of target cells of the target region or induce apoptosis of target cells of the target region, an electrode portion comprising the multi-layered electrode structure of any one of claims 1 to 9, and an electrode fixing portion for fixing the electrode portion to the target region of the target object.