CN118649351A - An implantable neural stimulation system - Google Patents

Abstract

The present application provides an implantable neurostimulation system, which includes an implantable flexible electrode and an implantable neurostimulator. The implantable flexible electrode includes a proximal contact portion, a lead connection portion, a distal electrode portion and an auxiliary implant portion connected in sequence, the auxiliary implant portion is used to implant the implantable flexible electrode toward the target target area, the lead connection portion is provided with an anchor portion, the distal electrode portion includes at least one stimulation electrode site, and the stimulation electrode site is electrically connected to the proximal contact portion via the lead connection portion. The implantable neurostimulator is connected to the proximal contact portion, and the implantable neurostimulator includes a stimulation circuit module, which is electrically connected to the proximal contact portion to apply electrical stimulation to the target tissue through the stimulation electrode site. In this way, the situation where the stimulation effect is poor and the patient may be injured due to its movement is avoided, and the reliability and use effect of the implantable neurostimulation system are effectively improved.

Description

An implantable neural stimulation system

Technical Field

The present application relates to the technical field of biomedical engineering, and in particular, to an implantable neural stimulation system.

Background Art

As a neuromodulatory treatment method, nerve stimulation technology has been widely used in the treatment of various diseases in recent years. In particular, sacral nerve stimulation technology has been widely used in the treatment of various urinary system and intestinal diseases. Specifically, by generating electrical pulses acting on the sacral nerves, sacral nerve stimulators can effectively improve symptoms such as urinary retention, urinary incontinence, chronic pelvic pain and constipation.

However, traditional electrodes usually adopt a cylindrical structure. Although they can achieve electrical stimulation of the sacral nerves, they often cause damage to surrounding tissues during the implantation process. In addition, due to their lack of flexibility, these electrodes are prone to displacement after implantation, affecting the stimulation effect. Although sacral nerve stimulation can improve patient symptoms in the short term, its long-term efficacy and stability are still uncertain. Therefore, the current electrodes of neurostimulators have poor flexibility, which can easily cause damage to surrounding tissues during implantation in the human body, and are prone to displacement after implantation in the human body, thus affecting the treatment effect of the disease.

Summary of the invention

In response to the above-mentioned technical problems existing in the prior art, the present application provides an implantable neural stimulation system, which not only improves the flexibility and implantation safety of the implantable flexible electrode, but also enables the implantable flexible electrode to maintain stable contact with the target tissue after implantation, thereby providing more precise electrical stimulation.

The present application provides an implantable neurostimulation system, which includes an implantable flexible electrode and an implantable neurostimulator. The implantable flexible electrode is made of a flexible material, and includes a proximal contact portion, a lead connection portion, a distal electrode portion and an auxiliary implant portion connected in sequence, the auxiliary implant portion is used to implant the implantable flexible electrode toward the target area, an anchor portion is provided on the lead connection portion, and the distal electrode portion includes at least one stimulation electrode site, and the stimulation electrode site is electrically connected to the proximal contact portion via the lead connection portion. The implantable neurostimulator is connected to the proximal contact portion, and the implantable neurostimulator includes a stimulation circuit module, which is electrically connected to the proximal contact portion, so that the stimulation electrode site of the distal electrode portion is electrically connected to the stimulation circuit module via the lead connection portion and the proximal contact portion, so as to apply electrical stimulation to the target tissue through the stimulation electrode site.

In some embodiments, the anchoring portion has a thorn-like structure and/or a hollow structure, the thorn-like structure extends from the anchoring portion in a direction away from the lead connecting portion, and the hollow structure is located on a side of the lead connecting portion and/or on the lead connecting portion.

In some embodiments, the anchoring portion has a thorn-like structure, and the thorn-like structure is arranged obliquely relative to the lead connecting portion toward the direction where the proximal contact portion is located.

In some embodiments, the lead connection part of the implantable flexible electrode is constructed as a stacked structure, and the lead connection part includes a first flexible insulating layer, a second flexible insulating layer and a conductive layer, and the conductive layer is located between the first flexible insulating layer and the second flexible insulating layer.

In some embodiments, the anchoring portion is formed on the first flexible insulating layer and/or the second flexible insulating layer.

In some embodiments, the first flexible insulating layer and the second flexible insulating layer are made of one or a combination of the following materials: SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide; and/or the conductive layer is made of metal material.

In some embodiments, the conductive layer includes a first conductive layer arranged in contact with the first flexible insulating layer and a second conductive layer arranged in contact with the second flexible insulating layer. The lead connection portion also has a third flexible insulating layer along its thickness direction, and the third flexible insulating layer is placed between the first conductive layer and the second conductive layer.

In some embodiments, there are multiple first conductive layers, the multiple first conductive layers are arranged in parallel, and a fourth flexible insulating layer is arranged between adjacent first conductive layers; and/or, there are multiple second conductive layers, the multiple second conductive layers are arranged in parallel, and a fourth flexible insulating layer is arranged between adjacent second conductive layers.

In some embodiments, the outer contour edge of the thorn-like structure is in a straight line or an arc shape.

In some embodiments, the hollow structure has a polygonal and/or curved shape.

In some embodiments, the auxiliary implantation portion is configured as an auxiliary implantation hole or a groove.

In some embodiments, the distal electrode portion further includes at least one recording electrode site, and the recording electrode site is used to record the first potential signal of the target tissue.

In some embodiments, the shape of the stimulation electrode site is a combination of one or more of the following: circle, ellipse and polygon; and/or the shape of the recording electrode site is a combination of one or more of the following: circle, ellipse and polygon.

In some embodiments, the implantable neurostimulator further includes a recording module, which is electrically connected to a recording electrode site of the distal electrode portion and is used to obtain a first potential signal recorded by the recording electrode site.

In some embodiments, the implantable neurostimulator also includes a switching module, which is electrically connected to the stimulation circuit module and is used to control the stimulation circuit module to switch between a first working state and a second working state; wherein the stimulation circuit module in the first working state is used to send a pulse signal to the stimulation electrode site, and the stimulation circuit module in the second working state is used to record a second potential signal of the target tissue.

In some embodiments, the implantable neurostimulator also includes a radio frequency communication module, the implantable neurostimulation system also includes an external programmer, the external programmer also includes a wireless communication module, and the external programmer is wirelessly connected to the radio frequency communication module via the wireless communication module.

In some embodiments, the implantable neurostimulator further includes a power module and a rechargeable battery module, the power module is electrically connected to the rechargeable battery module, and the rechargeable battery module is used to provide power to the power module.

In some embodiments, the in vitro programmer also includes a wireless charging module, which is used to charge the power module of the implantable neurostimulator and perform at least one or more of the following operations on the power module: charging monitoring operation, charging control operation, overvoltage protection operation and overcurrent protection operation.

In some embodiments, the implantable neural stimulation system further includes a traction member, the distal end of which forms a traction portion, which acts on an auxiliary implant portion of the implantable flexible electrode to implant the implantable flexible electrode toward the target area via the auxiliary implant portion.

In some embodiments, the traction member is used to drive the traction portion to separate from the auxiliary implant portion of the implantable flexible electrode when a force is applied toward the proximal end.

Compared with the prior art, the beneficial effects of the embodiments of the present application are as follows: the auxiliary implant portion of the present application can implant the implantable flexible electrode toward the target area, the stimulation circuit module of the implantable neurostimulator can release electric pulses, and transmit them to the distal electrode portion via the proximal contact portion and the lead connection portion in sequence, and finally use the stimulation electrode site located on the distal electrode portion to apply electrical stimulation to the target tissue, thereby enhancing the functionality and reliability of the implantable neurostimulator, and the anchoring portion provided on the lead connection portion can increase the contact area between the implantable flexible electrode and the target tissue, so that the implantable flexible electrode can maintain stable contact with the target tissue after implantation, so that the implantable flexible electrode can be firmly fixed at the target position, providing more precise electrical stimulation, avoiding the poor stimulation effect caused by its movement and possible damage to the patient, and effectively improving the reliability and use effect of the implantable neurostimulation system.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar components in different views. The drawings generally illustrate various embodiments by way of example and not limitation, and together with the description and claims, serve to illustrate the disclosed embodiments. When appropriate, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the present apparatus or method.

FIG1 shows a schematic structural diagram of an implantable neural stimulation system according to an exemplary embodiment of the present application;

FIG2 shows a schematic structural diagram of an implantable flexible electrode according to an exemplary embodiment of the present application, wherein the anchoring portion shown in the figure includes a thorn-like structure;

FIG3 shows a schematic structural diagram of an implantable flexible electrode and a traction member according to an exemplary embodiment of the present application;

FIG4 shows a schematic block diagram of an implantable neural stimulator according to an exemplary embodiment of the present application;

FIG5 is a schematic diagram showing the structure of an implantable flexible electrode according to an exemplary embodiment of the present application, wherein the anchoring portion shown in the figure includes a thorn-like structure and a hollow structure;

FIG6 shows a schematic structural diagram of an implantable flexible electrode according to another exemplary embodiment of the present application, wherein the anchoring portion shown in the figure includes a thorn-like structure and a hollow structure;

FIG7 shows a schematic structural diagram of an implantable flexible electrode according to another exemplary embodiment of the present application, wherein the anchoring portion shown in the figure includes a thorn-like structure and a hollow structure;

FIG8 shows a schematic structural diagram of a lead connection portion according to an exemplary embodiment of the present application;

FIG. 9 shows a schematic flow chart of an implantable flexible electrode implantation process according to an exemplary embodiment of the present application.

The components indicated by the reference numerals in the figures are:

1. Implantable flexible electrode; 11. Proximal contact portion; 12. Lead connection portion; 121. Anchoring portion; 122. First flexible insulating layer; 123. Second flexible insulating layer; 124. Third flexible insulating layer; 125. Fourth flexible insulating layer; 126. Conductive layer; 127. First conductive layer; 128. Second conductive layer; 13. Distal electrode portion; 131. Stimulating electrode site; 132. Recording electrode site; 14. Auxiliary implantation portion; 2. Implantable neural stimulator; 21. Stimulation circuit module; 22. Switching module; 23. Radio frequency communication module; 24. Power supply module; 25. Rechargeable battery module; 3. In vitro programmer; 31. Wireless communication module; 32. Wireless charging module; 4. Traction piece; 41. Traction portion.

DETAILED DESCRIPTION

In order to enable those skilled in the art to better understand the technical solution of the present application, the present application is described in detail below in conjunction with the accompanying drawings and specific implementation methods. The embodiments of the present application are further described in detail below in conjunction with the accompanying drawings and specific implementation methods, but are not intended to limit the present application.

The words "first", "second" and similar words used in this application do not indicate any order, quantity or importance, but are only used to distinguish different parts. The words "include" or "comprises" and similar words mean that the elements before the word include the elements listed after the word, and do not exclude the possibility of including other elements. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

In the present application, when a specific device is described as being located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device. When a specific device is described as being connected to other devices, the specific device may be directly connected to the other device without an intermediate device, or may not be directly connected to the other device but have an intermediate device.

All terms (including technical terms or scientific terms) used in this application have the same meaning as those understood by ordinary technicians in the field to which this application belongs, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and should not be interpreted in an idealized or extremely formal sense, unless explicitly defined herein.

Technologies, methods, and equipment known to ordinary technicians in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

An implantable neural stimulation system is provided in one embodiment of the present invention, and the implantable neural stimulation system can be used in the medical field, etc. An implantable neural stimulation system according to an embodiment of the present invention will be described in detail below with reference to the accompanying drawings.

As shown in Figures 1, 2 and 3, the implantable neurostimulation system includes an implantable flexible electrode 1 and an implantable neurostimulator 2. The implantable flexible electrode 1 is made of a flexible material, and includes a proximal contact portion 11, a lead connection portion 12, a distal electrode portion 13 and an auxiliary implant portion 14 connected in sequence, the auxiliary implant portion 14 is used to implant the implantable flexible electrode 1 toward the target area, an anchor portion 121 is provided on the lead connection portion 12, and the distal electrode portion 13 includes at least one stimulation electrode site 131, and the stimulation electrode site 131 is electrically connected to the proximal contact portion 11 via the lead connection portion 12. As shown in Figure 4, the implantable neurostimulator 2 is connected to the proximal contact portion 11, and the implantable neurostimulator 2 includes a stimulation circuit module 21, which is electrically connected to the proximal contact portion 11, so that the stimulation electrode site 131 of the distal electrode portion 13 is electrically connected to the stimulation circuit module 21 via the lead connection portion 12 and the proximal contact portion 11, so as to apply electrical stimulation to the target tissue through the stimulation electrode site 131.

The above-mentioned implantable flexible electrode 1 can be made of flexible materials, for example, metal materials such as gold, platinum, iridium, etc. The above-mentioned materials have good electrical conductivity and biocompatibility, which can ensure that the implantable flexible electrode 1 can work stably for a long time, and also have a certain flexibility, so that the implantable flexible electrode 1 can be deformed with the movement of the human body component after being implanted into the human body component. Of course, the above-mentioned implantable flexible electrode 1 can also be made of non-metallic materials, or a combination of non-metallic materials and metal materials. This application does not specifically limit the materials used for the implantable flexible electrode 1.

The width of the above-mentioned implantable flexible electrode 1 ranges from 100 microns to 10 mm, and the thickness ranges from no more than 0.05 mm. This can ensure the flexibility and mechanical stability of the implantable flexible electrode 1, so that it can adapt to the structure of different implantation areas and reduce damage to the target tissue.

Optionally, the width from the lead connection part 12 to the auxiliary implant part 14 can be gradually narrowed, or the width from the distal electrode part 13 to the auxiliary implant part 14 can be gradually narrowed. This can help the implantable flexible electrode 1 to better adapt to different areas of the neural tissue, reduce damage to the neural tissue, and better adapt to the complex neural tissue structure.

The proximal end can be represented as the end close to the user, and conversely, the distal end can be represented as the end far from the user. The proximal contact portion 11 and the distal electrode portion 13 can be connected via the lead connection portion 12, and the electric pulse generated by the stimulation circuit module 21 in the implantable neurostimulator 2 can be sequentially transmitted to the proximal contact portion 11 via the stimulation electrode site 131 of the distal electrode portion 13 and the lead connection portion 12, and the proximal contact portion 11 is in contact with the target tissue, so that the target tissue can be acted on via the electric pulse.

The number of stimulation electrode sites 131 may range from 1 to 100, and the size of a single stimulation electrode site 131 may range from no less than 100 micrometers.

The auxiliary implantation part 14 may be disposed on a side of the distal electrode part 13 away from the user, and the implantable flexible electrode 1 may be accurately positioned at the target tissue through the auxiliary implantation part 14 .

The anchoring portion 121 can be understood as a component that can ensure that the implantable flexible electrode 1 stays at a specific position or avoids drifting during the process of implanting the above-mentioned implantable flexible electrode 1 into the target tissue. The anchoring portion 121 can be set on one side or both sides of the lead connection portion 12. The contact area between the implantable neural stimulation system and the human body component can be increased through the anchoring portion 121, thereby effectively fixing the position of the implantable neural stimulation system to prevent it from moving or falling off.

The anchoring portion 121 mentioned above can be understood to be integrated on the lead portion, which can play a role of deformation anchoring and achieve better implantation stability.

The number of the anchoring parts 121 may be 1 to 100, and the size of the anchoring parts 121 may range from 0.1 mm to 10 mm, which may be determined by the user according to actual use requirements, and the present application does not make any specific limitation on this.

The auxiliary implant part 14 of the present application can implant the implantable flexible electrode 1 toward the target area, and the stimulation circuit module 21 of the implantable neurostimulator 2 can release electric pulses, and transmit them to the distal electrode part 13 via the proximal contact part 11 and the lead connection part 12 in sequence, and finally use the stimulation electrode site 131 located on the distal electrode part 13 to apply electrical stimulation to the target tissue, thereby enhancing the functionality and reliability of the implantable neurostimulator 2. In addition, the anchoring part 121 provided on the lead connection part 12 can increase the contact area between the implantable flexible electrode 1 and the target tissue, so that the implantable flexible electrode 1 can maintain stable contact with the target tissue after implantation, so that the implantable flexible electrode 1 can be firmly fixed at the target position, providing more precise electrical stimulation, avoiding the poor stimulation effect caused by its movement and possible damage to the patient, and effectively improving the reliability and use effect of the implantable neurostimulation system.

In some embodiments, as shown in Figures 2 to 7, the anchoring portion 121 has a thorn-like structure and/or a hollow structure, the thorn-like structure extends from the anchoring portion 121 in a direction away from the lead connection portion 12, and the hollow structure is located on the side of the lead connection portion 12 and/or on the lead connection portion 12.

In the above embodiment, the anchoring portions 121 with different structures can have different contact areas with the target tissue. The user can use the implantable flexible electrode 1 with different anchoring portions 121 according to usage requirements or actual conditions, thereby achieving a better fixation effect and improving the flexibility and adaptability of the implantable neural stimulation system.

The anchoring portion 121 may have a thorn-like structure, or a hollow structure, or both. The anchoring portion 121 having a thorn-like structure may not only fix the implantable flexible electrode 1, but also prevent the implantable flexible electrode 1 from shifting after implantation. The anchoring portion 121 having a hollow structure allows the target tissue to be embedded in the hollow structure of the anchoring portion 121 after implantation, so that the implantable flexible electrode 1 and the target tissue can maintain a stable relative position relationship, provide better mechanical stability and reduce tissue intrusion, so as to provide a stronger anchoring effect.

As shown in Figures 1 to 3, the anchoring portion 121 shown in Figures 1 to 3 has a thorn-like structure instead of a hollow structure. The thorn-like structure can be understood as a sharp thorn-like structure formed by protruding outward from the side of the lead connecting portion 12, so as to effectively fix the position of the implantable flexible electrode 1 and prevent the implantable flexible electrode 1 from moving or falling off.

As shown in FIG5 , the anchoring portion 121 shown in FIG5 has a thorn-like structure and a hollow structure, and the thorn-like structure and the hollow structure can be arranged in combination, that is, the hollow structure can be arranged on the thorn-like structure, and the combination of the two can achieve a better anchoring effect. Of course, the above-mentioned thorn-like structure and the hollow structure can also be arranged independently, such as the hollow structure is directly arranged on the surface of the lead connecting portion 12, and the thorn-like structure is arranged on the side of the lead connecting portion 12. The present application does not specifically limit the arrangement relationship between the thorn-like structure and the hollow structure, and it is sufficient to achieve stable fixation of the implantable flexible electrode 1.

As shown in Figures 6 and 7, the anchoring portion 121 shown in Figures 6 and 7 has a hollow structure instead of a thorn-like structure. The hollow structure shown in Figure 6 is arranged on the side of the lead connecting portion 12, and the hollow structure shown in Figure 7 is arranged on the surface of the lead connecting portion 12.

In some embodiments, as shown in FIG. 2 , the anchoring portion 121 has a thorn-like structure, and the thorn-like structure is arranged obliquely relative to the lead connecting portion 12 toward the direction where the proximal contact portion 11 is located.

In the above embodiment, the anchoring portion 121 with a thorn-like structure can firmly fix the implantable flexible electrode 1 at the target tissue location, effectively avoiding the implantable flexible electrode 1 from falling off and moving, and further improving the reliability of the implantable neural stimulation system.

The inclination direction of the thorn-like structure can be opposite to the implantation direction of the implantable neural stimulation system, that is, the thorn-like structure of the anchoring portion 121 is barbed, and the barbed thorn-like structure can effectively increase the contact area and friction with the target tissue. In addition, such a design can also help reduce resistance during the implantation process, so that the implantable flexible electrode 1 is firmly fixed to the target tissue position, so that the implantable neural stimulation system can smoothly and conveniently reach the target tissue.

In some embodiments, as shown in Figure 8, the lead connection part 12 of the implantable flexible electrode 1 is constructed as a stacked structure, and the lead connection part 12 includes a first flexible insulating layer 122, a second flexible insulating layer 123 and a conductive layer 126, and the conductive layer 126 is located between the first flexible insulating layer 122 and the second flexible insulating layer 123.

In this way, the first flexible insulating layer 122 and the second flexible insulating layer 123 can protect the conductive layer 126, so that the conductive layer 126 is isolated from the surrounding target tissue, thereby ensuring that the electric pulse can be accurately transmitted to the stimulation electrode site 131, effectively improving the reliability of the implantable flexible electrode 1.

The above-mentioned conductive layer 126 is arranged between the first flexible insulating layer 122 and the second flexible insulating layer 123, so that the conductive layer 126 and the surrounding target tissue are insulated, thereby allowing the electric pulses released by the implantable neurostimulator 2 to be transmitted to the stimulation electrode site 131 of the distal electrode part 13, avoiding the loss of electric pulses during the transmission process.

In some embodiments, the anchor portion 121 is formed on the first flexible insulating layer 122 and/or the second flexible insulating layer 123 .

In the above embodiment, the anchoring portion 121 can be arranged on the first flexible insulating layer 122 or the second flexible insulating layer 123 according to actual usage, so as to avoid contact between the anchoring portion 121 and the conductive layer 126, thereby ensuring the reliability of the implantable flexible electrode 1.

In some embodiments, the first flexible insulating layer 122 and the second flexible insulating layer 123 are made of one or a combination of the following materials: SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide; and/or the conductive layer 126 is made of a metal material.

Thus, the first flexible insulating layer 122 and the second flexible insulating layer 123 are made of the above insulating material to ensure the flexibility and biocompatibility of the implantable flexible electrode 1, and the conductive layer 126 is made of metal material to ensure effective signal conduction.

The conductive layer 126 can be made of a metal material having good conductivity and biocompatibility, so that the electric pulses released by the implantable neurostimulator 2 can reach the stimulation electrode site 131. The conductive layer 126 can be made of metal materials such as gold, platinum, iridium, etc. to ensure effective transmission of electrical signals.

The first flexible insulating layer 122 and the second flexible insulating layer 123 can be made of SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide. The above materials have good chemical stability and can ensure flexibility while also having strong mechanical strength.

In some embodiments, as shown in Figure 8, the conductive layer 126 includes a first conductive layer 127 arranged in contact with the first flexible insulating layer 122 and a second conductive layer 128 arranged in contact with the second flexible insulating layer 123, and the lead connecting portion 12 also has a third flexible insulating layer 124 along its thickness direction, and the third flexible insulating layer 124 is placed between the first conductive layer 127 and the second conductive layer 128.

In the above embodiment, the functionality and applicability of the implantable flexible electrode 1 can be further enhanced by configuring the first flexible insulating layer 122, the second flexible insulating layer 123, the first conductive layer 127, the second conductive layer 128 and the third flexible insulating layer 124. Among them, by providing the conductive layer 126 with the first conductive layer 127 and the second conductive layer 128, the conductive efficiency and conductive strength of the lead connecting part 12 can be effectively increased to meet the different usage requirements of users.

The third flexible insulating layer 124 may be made of one or a combination of the following materials: SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide.

In some embodiments, as shown in Figure 8, there are multiple first conductive layers 127, the multiple first conductive layers 127 are arranged in parallel, and a fourth flexible insulating layer 125 is arranged between adjacent first conductive layers 127; and/or, there are multiple second conductive layers 128, the multiple second conductive layers 128 are arranged in parallel, and a fourth flexible insulating layer 125 is arranged between adjacent second conductive layers 128.

In the above embodiment, by providing multiple first conductive layers 127 and/or multiple second conductive layers 128, the conductive efficiency and conductive strength of the lead connecting portion 12 can be further improved, thereby improving the flexibility and effect of the treatment, and by providing a fourth flexible insulating layer 125, the adjacent first conductive layers 127 and/or the adjacent second conductive layers 128 can be protected.

Exemplarily, there are two first conductive layers 127 and two second conductive layers 128 shown in FIG8 , and two adjacent first conductive layers 127 are provided with a fourth flexible insulating layer 125, and two adjacent second conductive layers 128 are provided with a fourth flexible insulating layer 125. Of course, the number of the first conductive layer 127 and the second conductive layer 128 may also be three, four, etc., and this application does not specifically limit this.

In some embodiments, as shown in FIG. 2 , the outer contour edge of the thorn-like structure is in the shape of a straight line or an arc.

In the above embodiment, the thorn-like structure with different shapes of outer contour edges can adapt to different implantation requirements, and can also make the anchoring between the anchoring portion 121 and the target tissue more firmly, effectively ensuring the tightness of the anchoring between the implantable flexible electrode 1 and the target tissue.

In some embodiments, as shown in FIG. 6 and FIG. 7 , the hollow structure has a polygonal and/or curved shape.

In the above embodiment, the anchoring portion 121 with a hollow structure of different shapes can form more contact relationships between the hollow structure and the target tissue, so that the anchoring portion 121 and the target tissue are more closely connected.

In some embodiments, as shown in FIGS. 1 to 7 , the auxiliary implantation portion 14 is configured as an auxiliary implantation hole or a groove.

In the above embodiment, the auxiliary implantation part 14 can ensure accurate positioning during the implantation process and reduce damage to the target tissue, thereby greatly facilitating the implantation operation of the implantable flexible electrode 1.

The user can use the auxiliary tool and drive the auxiliary implant part 14 to transport the stimulation electrode site 131 on the distal electrode part 13 to the target tissue position. The diameter of the auxiliary implant part 14 ranges from 0.002 mm to 2 mm. For example, the auxiliary tool can be the traction member 4 described below, which will not be described in detail here.

In some embodiments, as shown in FIGS. 3 to 7 , the distal electrode portion 13 further includes at least one recording electrode site 132 , and the recording electrode site 132 is used to record the first potential signal of the target tissue.

In the above embodiment, the recording electrode site 132 can record highly detailed and accurate electrical activity data, which greatly facilitates the user's analysis and evaluation of the treatment effect and effectively improves the practicality of the implantable neural stimulation system.

As shown in FIG. 3 , a stimulation electrode site 131 and a recording electrode site 132 may be respectively disposed on the distal electrode portion 13 , and the recording electrode site 132 is disposed at the distal end of the stimulation electrode site 131 .

The number of recording electrode sites 132 on the distal electrode portion 13 may range from 1 to 1000, and the size of a single recording electrode site 132 may range from no greater than 100 microns. The recording electrode sites 132 may be used to record action potentials at the single cell level, so that the user can accurately observe and analyze the electrical activity patterns of single cells.

In some embodiments, the shape of the stimulation electrode site 131 is a combination of one or more of the following: circle, ellipse and polygon; and/or the shape of the recording electrode site 132 is a combination of one or more of the following: circle, ellipse and polygon.

In the above embodiments, the shapes of the stimulation electrode sites 131 and/or the recording electrode sites 132 can be determined according to actual use requirements, thereby effectively increasing their adaptability in different neuroscience research and clinical applications.

In some embodiments, the implantable neurostimulator 2 further includes a recording module (not shown in the figure), which is electrically connected to the recording electrode site 132 of the distal electrode portion 13 for acquiring the first potential signal recorded by the recording electrode site 132 .

In the above embodiment, the recording module can record relevant data information in a timely manner so as to provide data basis for the treatment effect of the implantable neural stimulation system in the later stage, thereby effectively ensuring the reliability of the implantable neural stimulation system.

In some embodiments, as shown in FIG. 4 , the implantable neurostimulator 2 further includes a switching module 22, which is electrically connected to the stimulation circuit module 21 and is used to control the stimulation circuit module 21 to switch between a first working state and a second working state; wherein the stimulation circuit module 21 in the first working state is used to send a pulse signal to the stimulation electrode site 131, and the stimulation circuit module 21 in the second working state is used to record a second potential signal of the target tissue.

In the above embodiment, the user can use the switching module 22 to timely switch the different usage states of the stimulation circuit module 21 to meet different usage requirements, which can effectively improve the practicality and treatment effect of the implantable neural stimulator 2.

The first working state may be represented by the working state when the stimulation circuit module 21 applies electrical stimulation to the target tissue through the stimulation electrode site 131. The second working state may be represented by the working state when the stimulation circuit module 21 records the situation after applying electrical stimulation to the target tissue through the recording electrode site 132.

In some embodiments, as shown in Figure 4, the implantable neurostimulator 2 also includes a radio frequency communication module 23, the implantable neurostimulation system also includes an in vitro programmer 3, the in vitro programmer 3 also includes a wireless communication module 31, and the in vitro programmer 3 is wirelessly connected to the radio frequency communication module 23 via the wireless communication module 31.

In the above embodiment, the wireless communication module 31 of the extracorporeal programmer 3 can communicate wirelessly with the radio frequency communication module 23 of the implantable neurostimulator 2, so that the user can monitor and adjust the stimulation parameters without interfering with the patient's activities, thereby improving the flexibility and effectiveness of the treatment.

In some embodiments, as shown in FIG. 4 , the implantable neurostimulator 2 further includes a power module 24 and a rechargeable battery module 25 . The power module 24 is electrically connected to the rechargeable battery module 25 . The rechargeable battery module 25 is used to provide power to the power module 24 .

In the above embodiment, the rechargeable battery module 25 in the implantable neurostimulator 2 can provide continuous power supply to the power module 24 to meet the needs of long-term use, further improving the convenience and efficiency of the use of the implantable neurostimulator 2.

In some embodiments, as shown in Figures 1 and 4, the in vitro programmer 3 also includes a wireless charging module 32, which is used to charge the power module 24 of the implantable neurostimulator 2 and perform at least one or more of the following operations on the power module 24: charging monitoring operation, charging control operation, overvoltage protection operation and overcurrent protection operation.

In the above embodiment, the wireless charging module 32 of the in vitro programmer 3 can form a wireless connection with the power module 24 of the implantable neural stimulator 2, and effectively detect and control the power module 24, thereby further improving the flexibility, safety and reliability of the implantable neural stimulation system.

In some embodiments, as shown in Figure 3, the implantable neural stimulation system also includes a traction member 4, the distal end of the traction member 4 forms a traction portion 41, and the traction portion 41 acts on the auxiliary implant portion 14 of the implantable flexible electrode 1 to implant the implantable flexible electrode 1 toward the target area via the auxiliary implant portion 14.

In the above embodiment, the traction member 4 can form a physical connection with the auxiliary implantation portion 14 of the implantable flexible electrode 1 so that the distal electrode portion 13 of the implantable flexible electrode 1 is implanted toward the target area, effectively improving the convenience of implantation of the implantable flexible electrode 1.

The traction portion 41 is formed at the distal end of the traction member 4 . The shape of the traction portion 41 may be a pointed tip, or other shapes that can be stably connected to the auxiliary implant portion 14 . The present application does not impose any limitation on this.

The traction member 4 can be constructed in a cylindrical shape, and its diameter can range from 0.001 mm to 2 mm, and the distal end of the traction member 4 has a smaller diameter than its proximal end. This can ensure that the traction portion 41 at the distal end of the traction member 4 can smoothly penetrate the auxiliary implant portion 14 and can form a certain force on the auxiliary implant portion 14 to pull the distal electrode portion 13 to the target area.

In some embodiments, as shown in FIG. 9 , the traction member 4 is used to drive the traction portion 41 to separate from the auxiliary implantation portion 14 of the implantable flexible electrode 1 when subjected to a force acting toward the proximal end.

In the above embodiment, after the implantable flexible electrode 1 is implanted toward the target area using the traction member 4, the traction portion 41 is separated from the implantable flexible electrode 1 by applying a force toward the proximal end. This can simplify the implantation operation process and reduce damage to the surrounding target tissues, thereby effectively improving the user experience of the implantable neural stimulation system.

When the auxiliary implant part 14 is driven by the traction member 4 so that the distal electrode part 13 reaches the target tissue position, the user can apply a force toward the proximal end to separate the traction part 41 from the auxiliary implant part 14, thereby completing the implantation operation process of the implantable flexible electrode 1.

In addition, although exemplary embodiments have been described herein, the scope includes any and all embodiments based on the present application with equivalent elements, modifications, omissions, combinations (e.g., various embodiments intersecting schemes), adaptations or changes. The elements in the claims will be interpreted broadly based on the language used in the claims, and are not limited to the examples described in this specification or during the practice of the present application, and the examples will be interpreted as non-exclusive.

The above description is intended to be illustrative rather than restrictive. For example, the above examples (or one or more schemes thereof) may be used in combination with each other. For example, a person of ordinary skill in the art may use other embodiments when reading the above description. In addition, in the above-mentioned specific embodiments, various features may be grouped together to simplify the present application. This should not be interpreted as an intention that a disclosed feature that is not required to be protected is necessary for any claim. On the contrary, the subject matter of the present application may be less than all the features of a particular disclosed embodiment. Thus, the claims are incorporated herein into the specific embodiments as examples or embodiments, wherein each claim is independently a separate embodiment, and it is considered that these embodiments may be combined with each other in various combinations or arrangements. The scope of the present application should be determined with reference to the attached claims and the full scope of equivalent forms granted by these claims.

The above embodiments are only exemplary embodiments of the present application and are not intended to limit the present application. The protection scope of the present application is defined by the claims. Those skilled in the art may make various modifications or equivalent substitutions to the present application within the essence and protection scope of the present application, and such modifications or equivalent substitutions shall also be deemed to fall within the protection scope of the present application.

Claims (20)

1. An implantable neurostimulation system, comprising:

The implantable flexible electrode is made of a flexible material, and comprises a proximal contact part, a lead connecting part, a distal electrode part and an auxiliary implanting part which are sequentially connected, wherein the auxiliary implanting part is used for implanting the implantable flexible electrode towards a target area, an anchoring part is arranged on the lead connecting part, the distal electrode part comprises at least one stimulating electrode site, and the stimulating electrode site is electrically connected with the proximal contact part through the lead connecting part;

an implantable neurostimulator connected to the proximal contact portion, the implantable neurostimulator including a stimulation circuit module electrically connected to the proximal contact portion such that a stimulation electrode site of the distal electrode portion is electrically connected to the stimulation circuit module via the lead connection portion and the proximal contact portion to apply electrical stimulation to a target tissue through the stimulation electrode site.

2. The implantable neurostimulation system of claim 1, wherein the anchoring portion has a thorn-like structure extending from the anchoring portion in a direction away from the lead connection portion and/or a hollowed-out structure located on a side of and/or on the lead connection portion.

3. The implantable neurostimulation system of claim 2, wherein the anchoring portion has a spike-like structure that is disposed obliquely relative to the lead connection portion toward the direction in which the proximal contact portion is located.

4. The implantable neural stimulation system according to claim 1, wherein the lead connection of the implantable flexible electrode is configured as a laminate structure, the lead connection comprising a first flexible insulating layer, a second flexible insulating layer, and a conductive layer between the first and second flexible insulating layers.

5. The implantable neurostimulation system of claim 4, wherein the anchor is formed on the first and/or second flexible insulation layers.

6. The implantable neurostimulation system of claim 4, wherein the first flexible insulation layer and the second flexible insulation layer are made of one or a combination of materials of: SU-8 photoresist, parylene, fluorinated polymer and polyimide; and/or the number of the groups of groups,

The conductive layer is made of a metal material.

7. The implantable neural stimulation system according to claim 4, wherein the conductive layer comprises a first conductive layer provided to fit the first flexible insulating layer and a second conductive layer provided to fit the second flexible insulating layer, and wherein the lead connection portion further has a third flexible insulating layer disposed between the first conductive layer and the second conductive layer in a thickness direction thereof.

8. The implantable neurostimulation system of claim 7, wherein the first conductive layers are a plurality of, the plurality of first conductive layers being juxtaposed with a fourth flexible insulating layer disposed between adjacent ones of the first conductive layers; and/or the number of the groups of groups,

The second conductive layers are multiple, the second conductive layers are arranged in parallel, and a fourth flexible insulating layer is arranged between every two adjacent second conductive layers.

9. An implantable neurostimulation system according to claim 2 or 3, wherein the outer contour edge of the thorn-like structure is rectilinear or arcuate in shape.

10. The implantable neurostimulation system of claim 2, wherein the hollowed-out structure is polygonal and/or curvilinear in shape.

11. The implantable neurostimulation system of claim 1, wherein the auxiliary implant is configured as an auxiliary implant hole or recess.

12. The implantable neurostimulation system of claim 1, wherein the distal electrode portion further comprises at least one recording electrode site for recording a first potential signal of a target tissue.

13. The implantable neurostimulation system of claim 12, wherein the stimulation electrode sites are shaped as a combination of one or more of: circular, elliptical, and polygonal; and/or the number of the groups of groups,

The shape of the recording electrode sites is a combination of one or more of the following: circular, elliptical, and polygonal.

14. The implantable neurostimulation system of claim 12, further comprising a recording module electrically connected to a recording electrode site of the distal electrode portion for acquiring a first potential signal recorded by the recording electrode site.

15. The implantable neurostimulation system of claim 1, wherein the implantable neurostimulator further comprises a switching module electrically connected to the stimulation circuit module for controlling the stimulation circuit module to switch between a first operating state and a second operating state; the stimulation circuit module in the first working state is used for sending pulse signals to the stimulation electrode sites, and the stimulation circuit module in the second working state is used for recording second potential signals of target tissues.

16. The implantable neurostimulation system of claim 1, wherein the implantable neurostimulator further comprises a radio frequency communication module, the implantable neurostimulation system further comprises an external program control instrument, the external program control instrument further comprises a wireless communication module, and the external program control instrument is wirelessly connected with the radio frequency communication module through the wireless communication module.

17. The implantable neurostimulation system of claim 16, wherein the implantable neurostimulator further comprises a power module and a rechargeable battery module, the power module electrically connected to the rechargeable battery module, the rechargeable battery module for providing power to the power module.

18. The implantable neurostimulation system of claim 17, wherein the external programmer further comprises a wireless charging module for charging a power module of the implantable neurostimulator and at least one or more of: charge monitoring operation, charge control operation, overvoltage protection operation, and overcurrent protection operation.

19. The implantable nerve stimulation system according to claim 1, further comprising a traction element, a distal end of the traction element forming a traction portion that acts on an auxiliary implantation portion of the implantable flexible electrode to implant the implantable flexible electrode toward a target area via the auxiliary implantation portion.

20. The implantable neurostimulation system of claim 19, wherein the traction member is configured for causing the traction portion to disengage from the auxiliary implant portion of the implantable flexible electrode upon application of a proximally-directed force.