Implantable stroke treatment stimulation system

Abstract

The utility model discloses an implantable stroke treatment stimulation system, be suitable for skull, skull is provided with at least three interval arrangement's implantation hole, implantable stroke treatment stimulation system includes pulse generator and at least three electrode stimulation subassembly, at least three electrode stimulation subassembly is suitable for implanting in at least three implantation holes respectively, and electrode stimulation subassembly includes electrode part, and electrode part is connected in pulse generator through wire, wherein, at least one electrode part is arranged as positive electrode, and at least one electrode part is arranged as negative electrode. The utility model discloses implantable stroke treatment stimulation system can improve stimulation intensity, can accurate target small -range lesion, and stimulation is more accurate, can also control stimulation parameter and stimulation area, and dynamic adaptation is different patient's brain injury condition, and the stroke treatment effect is better.

Description

Technical Field

[0001] This utility model relates to the field of brain-computer interface technology, and in particular to an implantable stimulation system for stroke treatment. Background Technology

[0002] Currently, the main rehabilitation treatments for stroke include transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). These methods generate magnetic or electrical stimulation through the electrodes of the stimulation system to regulate the excitability of brain regions and improve motor and language functions, showing certain effectiveness in clinical practice. However, existing stimulators have electrodes fixed to the outer surface of the scalp, requiring the current to penetrate the scalp and skull, resulting in a very high attenuation rate. The actual current intensity that produces an effect is only 10% to 20% of the output value. Secondly, the current diffuses in a hemispherical shape, covering a large radius of the stimulation target, making it impossible to precisely target small lesions, which is not conducive to precise stimulation and rehabilitation. Utility Model Content

[0003] This invention aims to solve at least one of the technical problems existing in the prior art. To this end, this invention proposes an implantable stroke treatment stimulation system that not only increases stimulation intensity but also precisely targets small lesions, resulting in more accurate stimulation and thus better stroke treatment outcomes.

[0004] An implantable stroke treatment stimulation system according to an embodiment of the present invention is adapted to the skull, wherein the skull has at least three spaced-apart implantation holes. The implantable stroke treatment stimulation system includes a pulse generator and at least three electrode stimulation components. The at least three electrode stimulation components are adapted to be implanted into at least three of the implantation holes respectively. Each electrode stimulation component includes an electrode portion, which is electrically connected to the pulse generator via a wire. At least one of the electrode portions is configured as a positive electrode, and at least one of the electrode portions is configured as a negative electrode.

[0005] The implantable stroke treatment stimulation system according to the embodiments of this utility model has at least the following beneficial effects:

[0006] During treatment, at least three spaced implantation holes are made in the skull, and at least three electrode stimulation components are implanted into each of the three holes. A pulsed current generated by a pulse generator is transmitted to the electrode portion of the electrode stimulation component via corresponding wires. The electrode portion emits a stimulation waveform and a stimulation current, thereby performing the treatment. This application utilizes minimally invasive surgery to implant electrode stimulation components with electrode portions into the implantation holes. The electrode portions serve as current targets, allowing for precise targeting of small lesions within a predetermined brain region, resulting in more accurate stimulation and smaller range errors. Simultaneously, the electrodes penetrate deep into the skull, avoiding current attenuation by the scalp and skull, leading to high current transmission efficiency and excellent stimulation effect. Furthermore, by adjusting the current intensity, controlling the switching sequence of stimulation pulses from multiple electrode portions, and matching the positive and negative poles of the electrode portions, stimulation parameters can be adjusted. Through electrical conduction between the pulse generator and different electrode portions, the stimulation area can be controlled, dynamically adapting to the brain injury conditions of different patients, resulting in better stroke treatment outcomes, especially suitable for patients for whom existing TMS / tDCS devices are ineffective.

[0007] According to some embodiments of the present invention, the electrode stimulation assembly further includes a skull nail, which includes a stud portion and a screwing portion. The outer peripheral wall of the stud portion is formed with external threads, and the stud portion is adapted to be screwed into the implantation hole. The screwing portion is connected to the top of the stud portion, and the top of the screwing portion is provided with an operating groove, which is adapted to allow a screwdriver to be inserted to rotate the skull nail. The outer surfaces of the stud portion and the screwing portion are both provided as electrically insulating surfaces, and the electrode portion is located below the skull nail.

[0008] According to some embodiments of the present invention, the skull nail and the electrode portion are separate structures. The electrode stimulation assembly further includes a spring, which is adapted to be implanted in the implantation hole. The top of the spring abuts against the bottom of the stud portion, and the bottom of the spring abuts against the top of the electrode portion.

[0009] According to some embodiments of the present invention, the wire is connected to the electrode portion, and a first wiring groove is provided in the wall of the implantation hole, and the wire is adapted to run through the first wiring groove.

[0010] According to some embodiments of the present invention, the skull nail is made of polyetheretherketone; or, the skull nail is made of medical titanium alloy, and the outer surface of the skull nail is formed with an electrically insulating layer by anodizing.

[0011] According to some embodiments of this utility model, the electrode part is connected to the bottom of the stud part to form an integral structure, the skull nail is provided with a mounting hole, the bottom surface of the mounting hole forms a first conductive surface, the outer surface of the electrode part forms a second conductive surface, the first conductive surface and the second conductive surface are electrically connected, the electrode stimulation assembly also includes a conductive part, the conductive part is installed in the mounting hole, the bottom surface of the conductive part is attached to the first conductive surface, and the wire is connected to the conductive part.

[0012] According to some embodiments of the present invention, the electrode stimulation assembly further includes an electrically insulating post, which is installed in the mounting hole, with the bottom of the electrically insulating post abutting against the top of the conductive part, and the electrically insulating post having a wiring hole for the wire to pass through.

[0013] According to some embodiments of the present invention, the bottom of the electrically insulating column is provided with a positioning groove that communicates with the wiring hole, the top of the conductive part is formed with a protrusion, the protrusion is inserted into the positioning groove, and the wire is connected to the top of the protrusion.

[0014] According to some embodiments of the present invention, the top end of the mounting hole is connected to the operating groove, and at least one outer end of the operating groove extends outward to form a second wiring groove. The wire passes through the top end of the mounting hole and is routed through the second wiring groove.

[0015] According to some embodiments of the present invention, at least one of the electrode portions is configured to be in a de-energized state.

[0016] Additional aspects and advantages of this invention will be set forth in part in the description which follows, and some of these additional aspects and advantages will become apparent from the description or may be learned by practice of the invention. Attached Figure Description

[0017] The present invention will be further described below with reference to the accompanying drawings and embodiments, wherein:

[0018] Figure 1 This is a schematic diagram of the installation of the implantable stroke treatment stimulation system according to the first embodiment of this utility model;

[0019] Figure 2 for Figure 1 A partial sectional view;

[0020] Figure 3 for Figure 2 A schematic diagram of the implantation hole penetrating the skull;

[0021] Figure 4 for Figure 2 A schematic diagram of the skull nail structure;

[0022] Figure 5 for Figure 2 A schematic diagram of the spring structure in the diagram;

[0023] Figure 6 for Figure 2 Schematic diagram of the connection between the electrode section and the wire.

[0024] Figure 7 This is a schematic diagram of the installation of the implantable stroke treatment stimulation system according to the second embodiment of this utility model;

[0025] Figure 8 for Figure 7 A partial sectional view;

[0026] Figure 9 for Figure 8 A schematic diagram of the skull nail structure;

[0027] Figure 10 for Figure 9 The cross-sectional view of the skull screw shown;

[0028] Figure 11 for Figure 8 A schematic diagram showing the fit between the conductive part and the electrically insulating pillar;

[0029] Figure 12 This is a schematic diagram showing the arrangement of multiple implantation holes;

[0030] Figure 13 for Figure 12 A magnified view of the implantation hole with the first wiring groove;

[0031] Figure 14 This is a schematic diagram of the pulse generator.

[0032] Figure 15 This is a schematic diagram illustrating the interaction between the pulse generator and external devices.

[0033] Icon labels:

[0034] Pulse generator 100; housing 101; circuit board 102; feedthrough connector 103; energy coil 104; data antenna 105; electrode connector 106;

[0035] Electrode stimulation assembly 200; electrode part 201; wire 202; skull nail 203; stud part 204; screwing part 205; operating groove 206; spring 207; mounting hole 208; first conductive surface 209; second conductive surface 210; conductive part 211; electrically insulating post 212; wiring hole 213; positioning groove 214; protrusion 215; second wiring groove 216; polished surface 217;

[0036] Skull 300; Implantation hole 301; First wiring groove 302; Dura mater 303. Detailed Implementation

[0037] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain this utility model, and should not be construed as limiting this utility model.

[0038] The following is for reference. Figures 1 to 15 This invention describes an implantable stroke treatment stimulation system according to an embodiment of the present invention.

[0039] refer to Figure 1 , Figure 7 and Figure 12 As shown, the implantable stroke treatment stimulation system according to an embodiment of the present invention is suitable for a skull 300, the skull 300 having at least three spaced-apart implantation holes 301, for example, referring to... Figure 12 As shown, nine implantation holes 301 can be made, and the number of implantation holes 301 is determined according to actual needs.

[0040] refer to Figures 1 to 3 , Figure 7 and Figure 8 As shown, the implantable stroke treatment stimulation system includes a pulse generator 100 and at least three electrode stimulation components 200. The at least three electrode stimulation components 200 are adapted to be implanted into at least three implantation holes 301. Each electrode stimulation component 200 includes an electrode portion 201, which is electrically connected to the pulse generator 100 via a wire 202. During treatment, at least one electrode portion 201 is configured as a positive electrode, and at least one electrode portion 201 is configured as a negative electrode. For example, some of the electrode portions 201 in the implantation holes 301 may be negative electrodes, while the electrode portions 201 in the remaining implantation holes 301 may be positive electrodes. (Reference) Figure 1 , Figure 7 and Figure 12 As shown, taking nine implantation holes 301 as an example, the nine implantation holes 301 can be arranged in an array. The electrode portion 201 in the middle implantation hole 301 can be a negative electrode, and the electrode portions 201 in the remaining implantation holes 301 are positive electrodes, surrounding the middle negative electrode, forming a current stimulation region between the positive and negative electrodes. The number of implantation holes 301 and the positive and negative electrode arrangement can have various possible combinations, and this invention is not limited to these. Each electrode portion 201 can be set as a positive electrode, a negative electrode, or set to a de-energized state.

[0041] During treatment, at least three spaced implantation holes 301 are made in the skull 300, and at least three electrode stimulation components 200 are respectively implanted into the at least three implantation holes 301. The pulse current generated by the pulse generator 100 is transmitted to the electrode part 201 of the electrode stimulation component 200 through the corresponding wire 202. The electrode part 201 emits stimulation waveform and stimulation current, thereby performing treatment.

[0042] In this application, an electrode stimulation component 200 with an electrode portion 201 is implanted into an implantation hole 301 in the skull 300 via minimally invasive surgery. The electrode portion 201 serves as a current target, precisely locating a predetermined brain region. It can accurately target small lesions (such as directly acting on the penumbra area after large vessel occlusion in ischemic stroke, damaged neurons around hematomas in hemorrhagic stroke, or specific functional areas such as the inferior frontal gyrus and motor cortex), resulting in more precise stimulation and smaller stimulation range errors. Simultaneously, the electrode portion 201 penetrates deep into the skull 300, avoiding current attenuation by the scalp and skull 300, resulting in high current transmission efficiency and good current stimulation effect. As one embodiment, the electrode portion 201 of this invention can also be used to collect electroencephalographic signals.

[0043] Furthermore, multiple electrode stimulation components 200 with electrode sections 201 can be implanted first. Postoperatively, based on the patient's brain injury CT / MRI images, different stimulation waveforms and stimulation currents can be generated by adjusting the current intensity of the pulse generator 100, controlling the switching sequence of stimulation pulses from multiple electrode sections 201, and matching the positive and negative poles of the electrode sections 201, thereby improving the effectiveness of stimulation therapy. Additionally, the pulse generator 100 can be electrically connected to electrode sections 201 at different locations; for example, only some electrode sections 201 can be discharged for stimulation, i.e., at least one electrode section 201 can be set to a de-energized state, to regulate the stimulation area.

[0044] In this way, by adjusting the stimulation parameters and stimulation area, it is possible to dynamically adapt to the different brain injury conditions of different patients (such as adapting to different infarct sizes and different hemorrhage absorption), resulting in better stroke treatment and rehabilitation effects. It can effectively improve the motor, language and cognitive functions of stroke patients, and is especially suitable for patients who have not responded to existing TMS / tDCS equipment treatment.

[0045] refer to Figures 2 to 4 , Figures 8 to 10As shown, the electrode stimulation assembly 200 also includes a skull nail 203, which includes a stud portion 204 and a screwing portion 205. The outer peripheral wall of the stud portion 204 is formed with external threads, and the stud portion 204 is adapted to be screwed into the implantation hole 301. The screwing portion 205 is connected to the top of the stud portion 204, and the top of the screwing portion 205 is provided with an operating groove 206. The operating groove 206 can be cross-shaped or slotted. The operating groove 206 is adapted to allow a screwdriver to be inserted to rotate the skull nail 203. The screwdriver can be an ordinary screwdriver or an electric screwdriver, which will not be described in detail here. The outer surfaces of the stud portion 204 and the screwing portion 205 are both set as electrically insulating surfaces. The electrode portion 201 is located below the skull nail 203.

[0046] In this embodiment, the stud portion 204 of the skull nail 203 has external threads. A screwdriver is inserted into the operating groove 206 of the screwing portion 205 of the skull nail 203, and the screwdriver is operated to screw the stud portion 204 of the skull nail 203 into the implantation hole 301. This allows the electrode stimulation assembly 200 to be fixed to the skull 300. The structure is simple and easy to operate, significantly reducing the workload of medical staff. Furthermore, the outer surfaces of both the stud portion 204 and the screwing portion 205 are electrically insulating, effectively preventing current emitted from the electrode portion 201 from leaking to non-treatment areas of the patient's head through these surfaces, thus improving the treatment effect.

[0047] In some embodiments of this invention, the skull nail 203 is made of medical-grade titanium alloy, and the outer surfaces of the stud portion 204 and the screwing portion 205 are anodized to form an electrically insulating layer. For example, the skull nail 203 can be made of medical-grade titanium alloy Ti 6Al4V-ELI or other suitable types of medical-grade titanium alloy.

[0048] In this embodiment, the skull nail 203 is made of medical-grade titanium alloy. Titanium alloy has reliable biocompatibility, is non-toxic and non-allergenic to human tissue, and is lightweight and has good corrosion resistance. An electrically insulating layer is formed on the outer surface of the stud portion 204 and the outer surface of the screw portion 205 through anodizing, which can prevent the current on the electrode portion 201 from leaking to the non-treatment area of ​​the patient's head through the skull nail 203.

[0049] In some embodiments of this invention, the thickness of the electrically insulating layer formed by anodizing the outer surface of the stud portion 204 and the outer surface of the screw portion 205 is 4 to 6 μm. This not only improves the leakage prevention effect of the skull nail 203 but also avoids the use of the skull nail 203 from being affected by an excessively thick electrically insulating layer.

[0050] In some embodiments of this invention, the outer peripheral wall of the conductor 202 is covered with an electrically insulating layer. For example, the electrically insulating layer covering the outer peripheral wall of the conductor 202 can be made of polyimide or other suitable electrically insulating materials. This prevents leakage of current from the conductor 202.

[0051] The following is for reference. Figures 1 to 6 and Figure 13 This describes a scheme where the skull nail 203 and the electrode part 201 of the electrode stimulation assembly 200 of this utility model are separate structures.

[0052] refer to Figures 2 to 6 As shown, in some embodiments of this invention, when the skull nail 203 and the electrode portion 201 are separate structures, the electrode stimulation assembly 200 further includes a spring 207. The spring 207 is adapted to be implanted into the implantation hole 301, with the top of the spring 207 abutting against the bottom of the stud portion 204 and the bottom of the spring 207 abutting against the top of the electrode portion 201. For example, the spring 207 can be a helical compression spring 207, and the effective number of turns of the spring 207 can be 3 to 5 turns. During treatment, the bottom end of the electrode portion 201 is placed in the implantation hole 301, the spring 207 is placed in the implantation hole 301, and then the stud portion 204 of the skull nail 203 is screwed into the implantation hole 301, so that the top of the spring 207 abuts against the bottom of the stud portion 204 and the bottom of the spring 207 abuts against the top of the electrode portion 201.

[0053] In this embodiment, the skull nail 203 and the electrode part 201 are separate structures, which are relatively convenient to manufacture. In addition, a spring 207 is provided between the electrode part 201 and the stud part 204. The spring 207 can not only apply elastic pressure to the electrode part 201 to avoid damage to the electrode part 201 and to avoid injuring the patient's brain, but also fill the distance difference when the thickness of the skull 300 is different or the depth of the stud part 204 of the skull nail 203 into the implantation hole 301 is different. This allows the stud part 204 of the skull nail 203 in each implantation hole 301 to abut against the corresponding electrode part 201, thereby making the placement of the electrode part 201 more stable.

[0054] It should be noted that the reference Figure 2 As shown, the implantation hole 301 can be a blind hole structure, meaning that the bottom of the implantation hole 301 does not penetrate through the skin. In this case, the electrode portion 201 does not adhere to the patient's dura mater 303. (Reference) Figure 3 As shown, the implantation hole 301 can also be a through hole structure, that is, the bottom end of the implantation hole 301 is through-hole. In this case, the bottom surface of the electrode part 201 can be attached to the patient's dura mater 303.

[0055] refer to Figures 1 to 3 , Figure 6 and Figure 13 As shown, in some embodiments of this utility model, when the skull nail 203 and the electrode part 201 are separate structures, the wire 202 is connected to the electrode part 201, and the wall of the implantation hole 301 is provided with a first wiring groove 302, and the wire 202 is adapted to run through the first wiring groove 302. For example, the wire 202 and the electrode part 201 can be welded to each other, the top end of the first wiring groove 302 can extend to the top end of the implantation hole 301 and pass through it, the bottom end of the first wiring groove 302 can extend to the bottom end of the implantation hole 301, and the first wiring groove 302 can be opened by a reciprocating saw.

[0056] In this embodiment, a first wiring groove 302 is opened in the wall of the implantation hole 301, which makes it easier to run the wire 202 and avoids the wire 202 from affecting the installation of the skull nail 203. After the wire 202 extends out of the implantation hole 301, it is led out from one side of the skull nail 203.

[0057] In some embodiments of this invention, when the skull nail 203 and the electrode part 201 are separate structures, the length of the stud part 204 is set at 3mm-4mm, the length of the spring 207 in its natural state is 2mm-4mm, and the minimum length of the spring 207 in its compressed state is 1mm-2mm. This is well-suited to the fact that the thickness of an adult skull 300 is typically 7 to 10mm, allowing for proper compression of the electrode part 201 while avoiding excessive pressure that could damage the electrode part 201 or injure the patient's head.

[0058] In some embodiments of this invention, the spring 207 is made of medical-grade stainless steel. For example, the spring 207 may be made of LVM, a biocompatible medical-grade stainless steel, or other suitable medical-grade stainless steel.

[0059] In this embodiment, the spring 207 is made of medical-grade stainless steel, which not only has excellent corrosion resistance, but also reliable biocompatibility, is non-toxic and non-allergenic to human tissues, and also has good elastic properties.

[0060] refer to Figure 5 As shown, in some embodiments of this utility model, the two ends of the spring 207 are respectively ground to form a polished surface 217. The polished surface 217 at the top of the spring 207 is attached to the bottom surface of the stud portion 204, and the polished surface 217 at the bottom of the spring 207 is attached to the top surface of the electrode portion 201. In this way, stress concentration can be reduced, which not only improves the effect of pressing the electrode portion 201, but also reduces the damage to the electrode portion 201.

[0061] In some embodiments of this invention, when the skull nail 203 and the electrode portion 201 are separate structures, the skull nail 203 can be made of medical-grade titanium alloy or polyetheretherketone (PEEK). PEEK has reliable biocompatibility, is non-toxic and non-allergenic to human tissue, and has excellent electrical insulation properties, preventing current from the electrode portion 201 from leaking through the skull nail 203 to non-treatment areas of the patient's head.

[0062] In some embodiments of this invention, when the skull nail 203 and the electrode portion 201 are separate structures, the outer peripheral wall of the bottom of the stud portion 204 is chamfered. In this embodiment, the chamfering of the outer peripheral wall of the bottom of the stud portion 204 makes it easier for the stud portion 204 of the skull nail 203 to be screwed into the implantation hole 301 of the skull 300 via self-tapping.

[0063] The following is for reference. Figures 7 to 11 This describes a scheme in which the skull nail 203 and the electrode part 201 of the electrode stimulation assembly 200 of this utility model are an integral structure.

[0064] refer to Figures 7 to 11 As shown, in some embodiments of this utility model, the electrode part 201 is connected to the bottom of the stud part 204 to form an integral structure. The skull nail 203 is provided with a mounting hole 208, which can extend along the axial direction of the stud part 204. The top end of the mounting hole 208 can be through-hole, and the bottom surface of the mounting hole 208 can be the top surface of the electrode part 201. Of course, the mounting hole 208 can also extend into the interior of the electrode part 201. The bottom surface of the mounting hole 208 forms a first conductive surface 209, and the outer surface of the electrode part 201 forms a second conductive surface 210. The first conductive surface 209 and the second conductive surface 210 are electrically connected. The electrode stimulation assembly 200 also includes a conductive part 211, which is installed in the mounting hole 208. The bottom surface of the conductive part 211 is attached to the first conductive surface 209. The wire 202 is connected to the conductive part 211. For example, the wire 202 can be welded to the conductive part 211, and the wire 202 extends out of the skull nail 203.

[0065] In this embodiment, the outer surfaces of the stud portion 204 and the screw portion 205 of the skull nail 203 are electrically insulating surfaces, with only the electrode portion 201 at the bottom being conductive. The wire 202 is electrically connected to the electrode portion 201 through the conductive portion 211 and the first conductive surface 209 inside the skull nail 203. In this way, the current emitted from the second conductive surface 210 of the electrode portion 201 can be further prevented from leaking to the non-treatment area of ​​the patient's head, thereby improving the treatment effect.

[0066] It should be noted that when the skull nail 203 is made of medical titanium alloy, and the outer surface of the stud portion 204 and the outer surface of the screw portion 205 are formed with an electrically insulating layer by anodizing, the conductivity of the first conductive surface 209 and the second conductive surface 210 can be formed by covering it with a protective layer during the anodizing process, or by removing the surface oxide layer of the first conductive surface 209 and the second conductive surface 210.

[0067] refer to Figure 8 and Figure 11 As shown, in some embodiments of this utility model, the electrode stimulation assembly 200 further includes an electrically insulating post 212, installed within the mounting hole 208. The bottom of the electrically insulating post 212 abuts against the top of the conductive part 211, and the electrically insulating post 212 is provided with a wiring hole 213 for the wire 202 to pass through. For example, a small gap may exist between the outer peripheral wall of the electrically insulating post 212 and the wall of the mounting hole 208, the gap being 0.05-0.12 mm, thus facilitating the installation of the electrically insulating post 212 within or removal from the mounting hole 208. The wiring hole 213 may be coaxial with the electrically insulating post 212. After the wire 202 passes through the wiring hole 213, the wire 202 can be bonded to the electrically insulating post 212 using silicone adhesive.

[0068] In this embodiment, an electrical insulating post 212 is installed in the mounting hole 208. The electrical insulating post 212 can not only cooperate with the mounting hole 208 to limit the conductive part 211, preventing the conductive part 211 from moving at will and affecting the conductivity, but also play an electrical insulation role, reducing leakage. In addition, it facilitates the routing of the wire 202 and reduces the occurrence of wire 202 tangling.

[0069] refer to Figure 8 and Figure 11 As shown, in some embodiments of this utility model, the bottom of the electrically insulating post 212 is provided with a positioning groove 214 that connects to the wiring hole 213, and a protrusion 215 is formed on the top of the conductive part 211. The protrusion 215 is inserted into the positioning groove 214, and the wire 202 is connected to the top of the protrusion 215.

[0070] In this embodiment, the positioning groove 214 and the protrusion 215 cooperate to limit the conductive part 211 in the vertical and horizontal directions, thereby further preventing the conductive part 211 from moving arbitrarily and affecting the conductivity. In addition, the welding position of the wire 202 and the conductive part 211 is located in the positioning groove 214, which can form protection for the welding point, making the welding of the wire 202 and the conductive part 211 more stable and the conductivity better.

[0071] In some embodiments of this utility model, the electrically insulating post 212 is made of polyetheretherketone (PEEK). In this embodiment, the electrically insulating post 212 is made of PEEK, which has reliable biocompatibility, is non-toxic and non-allergenic to human tissues, and has excellent electrical insulation properties.

[0072] refer to Figures 8 to 10 As shown, in some embodiments of this utility model, the top end of the mounting hole 208 is connected to the operation groove 206, and at least one outer end of the operation groove 206 extends outward to form a second wiring groove 216. For example, one of the outer ends of the operation groove 206 may extend outward to form a second wiring groove 216. The wire 202 passes through the top end of the mounting hole 208 and is routed through the second wiring groove 216.

[0073] In this embodiment, the top end of the mounting hole 208 is connected to the operating groove 206, which facilitates the wire 202 to extend from the top end of the mounting hole 208 into the skull screw 203. Moreover, the operating groove 206 is not only used for inserting a screwdriver to rotate the skull screw 203, but at least one outer end of the operating groove 206 also extends outward to form a second wiring groove 216, which facilitates the wiring of the wire 202 after it extends out of the skull screw 203, making the surgical process more convenient.

[0074] refer to Figures 8 to 10 As shown, in some embodiments of this invention, the second conductive surface 210 is configured as a convex arc surface. In this embodiment, configuring the second conductive surface 210 as a convex arc surface not only avoids the electrode portion 201 from being too sharp and causing damage to the patient's skull 300, but also makes the conductive area of ​​the second conductive surface 210 larger, thereby resulting in a better effect of electrical stimulation therapy.

[0075] In some embodiments of this utility model, when the skull nail 203 and the electrode part 201 are an integral structure, the implantation hole 301 is set as a threaded hole adapted to the stud part 204. Since the skull nail 203 is a hollow structure, it may be damaged due to insufficient structural strength when it is tapped and screwed into the implantation hole 301. In this application, the implantation hole 301 is first processed into a threaded hole using a tapping device, which can avoid damage to the skull nail 203.

[0076] In some embodiments of this invention, when the skull nail 203 and the electrode part 201 are an integral structure, the length of the stud part 204 is set to 4mm-7mm. This is just right to fit the 300mm thickness of an adult skull.

[0077] In some embodiments of this invention, the pulse generator 100 can be an implantable pulse generator (IPG), which can be implanted in the skull 300, chest, or other locations. When the pulse generator 100 is implantable, it can be powered by wireless charging or a built-in battery. Of course, the pulse generator 100 can also be disposed externally, as long as it can be electrically connected to the electrode part 201.

[0078] refer to Figure 12 As shown, in some embodiments of this utility model, the pulse generator 100 includes a housing 101, a circuit board 102, a feedthrough connector 103, an energy coil 104, and a data antenna 105.

[0079] The circuit board 102 is located inside the housing 101. The feedthrough connector 103 is located in the housing 101 and connected to the circuit board 102. The wire 202 is connected to the feedthrough connector 103. The energy coil 104 is connected to the feedthrough connector 103, and the data antenna 105 is connected to the feedthrough connector 103. For example, the feedthrough connector 103 can be a ceramic feedthrough connector 103. The feedthrough connector 103 can be located at the opening of the housing 101 and seal the housing 101. The feedthrough connector 103 is connected to the circuit board 102 inside the housing 101. The wire 202 can be directly connected to the feedthrough connector 103, or it can be connected to the feedthrough connector 103 through an electrode connector 106. The energy coil 104 and the data antenna 105 can be located on the outside of the housing 101 and covered by a protective structure. The energy coil 104 receives electrical energy from a power source, such as a portable power supply, through electromagnetic induction to achieve wireless power supply. Alternatively, the pulse generator 100 can also have a built-in battery, which will not be elaborated further here. The data antenna 105 is used to exchange signals with external devices, providing bidirectional signal transmission.

[0080] In this embodiment, the pulse generator 100 can be implanted in the human body and can transmit data and energy wirelessly, making it more convenient to use.

[0081] The following is for reference. Figure 15 As shown, taking the pulse generator 100 as an implantable pulse generator (IPG) as an example, the interaction between the pulse generator 100 and external devices is briefly described. It should be noted that the following description is only an illustrative example and is not intended to limit the solution of this application.

[0082] External devices may include computers, programmable controllers, etc. The software in the computer, such as DAC software, uses the Bluetooth module to set up the system and configure the parameters of the programmable controller.

[0083] The portable power supply provides power to the programmable controller and allows for parameter fine-tuning via buttons;

[0084] The programmable controller provides system power and bidirectional data communication to the implantable pulse generator via wireless transmission. Specifically, the energy coil 104 provides power to the implantable pulse generator via wireless power transmission; the data antenna 105 uses wireless communication to provide stable bidirectional data transmission for the system.

[0085] The implantable pulse generator is configured according to the stimulation parameters sent by the programmable controller. After being processed by the MCU on the circuit board 102, it sends the corresponding stimulation waveform and stimulation current to the brain tissue through the electrode section 201.

[0086] In some embodiments of this invention, the energy coil 104 operates at a frequency of 135.6 kHz, and the data antenna 105 operates at a frequency of 2.4 GHz. This prevents mutual interference between the energy coil 104 and the data antenna 105.

[0087] The embodiments of the present utility model have been described in detail above with reference to the accompanying drawings. However, the present utility model is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present utility model.

Claims

1. An implantable stimulation system for stroke treatment, adapted to the skull, wherein the skull has at least three spaced-apart implantation holes, characterized in that, include: Pulse generator; At least three electrode stimulation components are adapted to be implanted into at least three of the implantation holes, each electrode stimulation component including an electrode portion electrically connected to the pulse generator via a wire, wherein at least one of the electrode portions is configured as a positive electrode and at least one of the electrode portions is configured as a negative electrode.

2. The implantable stroke treatment stimulation system according to claim 1, characterized in that, The electrode stimulation assembly also includes: The skull screw includes a stud portion and a screwing portion. The outer peripheral wall of the stud portion has an external thread. The stud portion is adapted to be screwed into the implantation hole. The screwing portion is connected to the top of the stud portion. The top of the screwing portion is provided with an operating groove. The operating groove is adapted to allow a screwdriver to be inserted to rotate the skull screw. The outer surfaces of the stud portion and the screwing portion are both provided as electrically insulating surfaces. The electrode portion is located below the skull screw.

3. The implantable stroke treatment stimulation system according to claim 2, characterized in that, The cranial nail and the electrode portion are separate structures, and the electrode stimulation assembly further includes: A spring, adapted to be implanted in the implantation hole, wherein the top of the spring abuts against the bottom of the stud portion and the bottom of the spring abuts against the top of the electrode portion.

4. The implantable stroke treatment stimulation system according to claim 3, characterized in that, The wire is connected to the electrode portion, and a first wiring groove is provided in the wall of the implantation hole, and the wire is adapted to run through the first wiring groove.

5. The implantable stroke treatment stimulation system according to claim 3, characterized in that, The skull nail is made of polyetheretherketone; or, the skull nail is made of medical titanium alloy, and the outer surface of the skull nail is formed with an electrically insulating layer by anodizing.

6. The implantable stroke treatment stimulation system according to claim 2, characterized in that, The electrode portion is connected to the bottom of the stud portion to form an integral structure. The cranial screw has a mounting hole, the bottom surface of which forms a first conductive surface, and the outer surface of the electrode portion forms a second conductive surface. The first conductive surface and the second conductive surface are electrically connected. The electrode stimulation assembly further includes: A conductive part is installed in the mounting hole, the bottom surface of the conductive part is attached to the first conductive surface, and the wire is connected to the conductive part.

7. The implantable stroke treatment stimulation system according to claim 6, characterized in that, The electrode stimulation assembly also includes: An electrically insulating post is installed in the mounting hole, with the bottom of the electrically insulating post abutting against the top of the conductive part, and the electrically insulating post having a wiring hole for the wire to pass through.

8. The implantable stroke treatment stimulation system according to claim 7, characterized in that, The bottom of the electrically insulating post is provided with a positioning groove that connects to the wiring hole, and the top of the conductive part is formed with a protrusion. The protrusion is inserted into the positioning groove, and the wire is connected to the top of the protrusion.

9. The implantable stroke treatment stimulation system according to claim 6, characterized in that, The top end of the mounting hole is connected to the operating groove, and at least one outer end of the operating groove extends outward to form a second wiring groove. The wire passes through the top end of the mounting hole and is routed through the second wiring groove.

10. The implantable stroke treatment stimulation system according to any one of claims 1 to 9, characterized in that, At least one of the electrodes is set to a de-energized state.

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