Implantable nerve regulation and control system suitable for craniocerebral injury and control method thereof

Abstract

The invention discloses an implantable nerve regulation and control system suitable for craniocerebral injury and a control method of the implantable nerve regulation and control system, and relates to the technical field of implantable medical instruments. The device comprises an implant and an in-vitro control patch. The implant can be independently implanted between the scalp and the skull or integrated on a functional layer in a groove in the dura mater side of a skull repair patch, and comprises an electrode array, induction coils in one-to-one correspondence and a control unit. The in-vitro patch comprises a transmitting coil array and a multi-channel driving circuit, is connected with the implant through wireless communication, and can perform independent regulation and control and self-adaptive power compensation on each channel according to a coupling state. The device can be implanted in a craniocerebral injury primary operation, so that the risk and treatment delay of a secondary operation are avoided. The invention further provides a corresponding closed-loop control method, and epilepsy suppression and exercise rehabilitation assistance are achieved through neural signal collection, abnormal event recognition, stimulation strategy matching and real-time adjustment.

Description

Technical Field

[0001] This invention relates to the field of implantable medical device technology, and in particular to an implantable neuromodulation system and its control method suitable for craniocerebral injury. Background Technology

[0002] Traumatic brain injury (TBI) is a common neurosurgical emergency. Postoperatively or during the recovery period, patients often experience epileptic-like discharges, abnormal neurological excitability, and limited recovery of motor and cognitive functions, severely impacting the rehabilitation process and quality of life. Currently used neurostimulation therapies face several technical bottlenecks: Firstly, traditional neurostimulators often require a secondary implantation surgery in the later stages of TBI surgery, significantly increasing surgical risks and trauma, and delaying the initiation of neuromodulation intervention, thus missing the optimal rehabilitation window. Secondly, existing devices largely rely on internal batteries for power or complex percutaneous leads to transmit energy and signals. Battery life is limited, requiring replacement surgery, while percutaneous leads are prone to infection, and both suffer from structural reliability issues.

[0003] Regarding the precision of stimulation modulation, existing technologies struggle to achieve fine-grained, multi-regional stimulation of the brain, making it impossible to tailor differentiated stimulation programs for functional abnormalities in different brain regions, thus limiting the modulatory effect. Furthermore, for traumatic brain injury patients requiring cranioplasty, the cranioplasty patch and neuromodulation device are often designed separately, lacking an integrated structure. This makes alignment and coupling between the external stimulation device and the implanted device difficult and unstable, and the heat generated during device operation is difficult to dissipate effectively, affecting both the stimulation effect and posing safety risks. In addition, existing systems lack a robust closed-loop control mechanism and safety protection design, making it difficult to dynamically adjust the stimulation strategy based on the patient's neural electrical activity in real time. Insufficient postoperative follow-up data hinders the optimization and adjustment of treatment plans, further restricting clinical application outcomes. Summary of the Invention

[0004] The purpose of this invention is to provide an implantable neuromodulation system and its modulation method suitable for traumatic brain injury. Through independent power supply and stimulation at the electrode level, adaptive coupling compensation, and closed-loop feedback control, it can achieve precise inhibition of neurological dysfunctions such as epilepsy and intelligent assistance for motor rehabilitation.

[0005] To achieve the above objectives, the present invention provides an implantable neuromodulation system suitable for traumatic brain injury, comprising an implant and an external control patch; The implant includes: a flexible substrate, and an electrode array, an induction coil, an energy conversion circuit, an implantation controller, and a first wireless communication module integrated on the flexible substrate; the electrode array and the induction coil are electrically connected in a one-to-one correspondence, each of the induction coils is electrically connected to the energy conversion circuit, and the energy conversion circuit and the first wireless communication module are respectively electrically connected to the implantation controller; The implant has two integrated structural forms: a) An independent flexible mesh structure, in which the electrode array, induction coil, energy conversion circuit, implantation controller and first wireless communication module are integrated on a flexible mesh substrate; b) Functional layer integrated structure, the flexible substrate and the integrated components together constitute the functional layer, which is embedded and fixed in the preset mesh groove on the side of the skull repair patch body near the dura mater, and fixed to the defect site of the skull through the edge threaded hole along with the skull repair patch. The external control patch includes a transmitting coil array, a driving circuit, an external controller, and a second wireless communication module. The transmitting coil array consists of several transmitting coils that are electrically connected to the driving circuit in a one-to-one correspondence. The driving circuit and the second wireless communication module are electrically connected to the external controller. The second wireless communication module establishes a wireless communication connection with the first wireless communication module. The transmitting coil array corresponds to the induction coil in a one-to-one correspondence, forming an electromagnetic coupling connection.

[0006] Preferably, the skull repair patch body is integrally molded from titanium alloy or polyetheretherketone material, including an inner bottom layer near the dura mater, a middle three-dimensional mesh structure layer, and an outer surface layer. The mesh groove is formed on the side of the inner bottom layer facing the dura mater. The contour of the mesh groove is adapted to the flexible base of the implant, and the depth of the mesh groove matches the thickness of the functional layer of the implant. The skull repair patch body also has a plurality of through channels distributed in a matrix corresponding to the positions of the electrode array.

[0007] Preferably, the inner wall of the through channel is provided with internal threads to accommodate hollow coupling screws made of polyetheretherketone (PEEK). The induction coil is sleeved around the periphery of the through channel. The axis of the hollow coupling screw is collinear with the central axis of the corresponding induction coil. The transmitting coil array is distributed and aligned with the induction coil. The induction coil is covered with a heat-insulating protective layer.

[0008] Preferably, a positioning and calibration structure is provided between the external control patch and the skull repair patch to achieve and maintain the alignment coupling between the transmitting coil array and the inductive coil; the positioning and calibration structure includes at least one of a physical alignment unit and an offset sensing unit. The physical alignment unit adopts a built-in magnetic attraction structure or a surface magnetic attraction structure; The built-in magnetic structure includes a T-shaped magnetic element disposed in the external control patch and a cylindrical magnetic element disposed inside the hollow coupling screw. A plurality of T-shaped holes are distributed in the external control patch. The T-shaped holes are arranged opposite to the through channel. The T-shaped elements are embedded in the T-shaped holes. The T-shaped magnetic elements and the cylindrical magnetic elements are attracted to each other and aligned. The surface magnetic attraction structure includes several sets of magnetic attraction units. Each set of magnetic attraction units consists of a magnetic attraction element and its corresponding non-magnetic attraction element. The magnetic attraction element and the non-magnetic attraction element are respectively embedded on the surfaces of the external control patch and the patch that are close to each other. The offset sensing unit is a Hall sensor, inertial measurement unit, or optical positioning mark integrated on the external control patch and / or the cranial repair patch, used to detect the alignment offset and feed it back to the external controller for coupling compensation.

[0009] Preferably, the electrode array is divided into multiple independent control zones, each zone containing at least one electrode; the electrodes in each zone form independent connection branches with dedicated induction coils and energy conversion circuits, and all independent branches are electrically connected to the implanted controller to achieve differentiated stimulation control of electrodes in different zones.

[0010] Preferably, the implanted controller and the external controller establish a bidirectional data synchronization connection through a first wireless communication module and a second wireless communication module to form a collaborative control architecture; the implanted controller is electrically connected to the electrode array and is responsible for the initial acquisition, preprocessing and rapid stimulation triggering of neurophysiological signals; the external controller is electrically connected to the drive circuit and is responsible for complex signal feature analysis, stimulation strategy optimization and adaptive power supply adjustment; the implanted controller and the external controller coordinate the output of control commands through data synchronization.

[0011] Preferably, a temperature sensor is integrated on the flexible substrate of the implant, and the temperature sensor is electrically connected to the implantation controller; a temperature sensor is also provided inside the shell of the external control patch, and it is electrically connected to the external controller; the external controller is configured to: when the temperature detected by any temperature sensor exceeds a preset safety threshold, reduce the driving power of the corresponding channel or stop the driving output through the driving circuit, and at the same time trigger the first wireless communication module and the second wireless communication module to synchronously provide safety warning information.

[0012] Preferably, a storage unit is integrated on the flexible substrate of the implant, and the storage unit is electrically connected to the implant controller; the storage unit is used to store a preset stimulation strategy library, a neural event log, and system operating parameters; the neural event log includes event timestamps, trigger feature data, executed stimulation parameters, and safety event records, and is transmitted to an external device through a first wireless communication module and a second wireless communication module.

[0013] An implantable neuromodulation system suitable for traumatic brain injury and its control method, comprising the following steps: Signal acquisition and transmission steps: Electrophysiological signals of the target brain region are acquired through the electrode array of the implant, and the signals are transmitted to the implant controller via the electrode array, or to the external controller via the first wireless communication module and the second wireless communication module. Feature analysis and event judgment steps: The implanted controller and / or external controller preprocess the signal and extract features to obtain at least one feature index. The feature index is compared with a preset threshold to determine whether a target neural event has occurred. Stimulation strategy decision-making steps: When a target neural event is determined to have occurred, a target stimulus strategy is selected from a pre-stored stimulus strategy library based on the event type and / or spatial location information. Stimulation parameter mapping and output steps: Determine the target stimulation intensity of the target electrode according to the target stimulation strategy, and map it to the driving parameters of the corresponding emission channel of the external control patch. The external controller drives the emission coil array to output energy through the driving circuit, which is transmitted to the induction coil through electromagnetic coupling, and then converted into stimulation current through the energy conversion circuit and output by the target electrode. Closed-loop feedback and adjustment steps: During or between stimulation outputs, the signal acquisition and transmission steps are repeated. Based on new neurophysiological signals and / or system state parameters, the target stimulation strategy and / or driving parameters are dynamically adjusted to form closed-loop control.

[0014] Preferably, the target neural events include epileptiform discharge events and / or training trigger signals transmitted by external rehabilitation devices and user interfaces; the stimulation strategy library includes inhibitory electrical stimulation strategies and enhancing electrical stimulation strategies, which correspond to two types of target neural events respectively, wherein the enhancing electrical stimulation strategies are adapted to the regulation of motor function-related brain regions within a preset time window.

[0015] According to specific embodiments provided by the present invention, the present invention discloses the following technical effects: (1) The implant has two integrated structural forms, which can be adapted to different clinical needs of craniocerebral injury surgery with or without skull repair, realize simultaneous implantation during surgery, avoid secondary surgical intervention, and at the same time, the groove of the implant and the skull repair patch are precisely matched to ensure the stability of the structure after implantation and improve the adhesion of the electrode to the target brain region.

[0016] (2) The matrix-type threaded holes of the skull repair patch and the hollow coupling screw form a through channel, which not only realizes the physical positioning of the external control patch and ensures the precise electromagnetic coupling between the transmitting coil and the induction coil, but also constructs an effective heat dissipation path, reduces local heat accumulation during device operation, and improves the safety of implantation.

[0017] (3) The electrode array and the induction coil are electrically connected one-to-one. Combined with the multi-channel independent adjustable drive circuit structure, it can realize the regional differential neural modulation of different brain regions. Moreover, the collaborative control architecture of the implanted controller and the external controller takes into account the real-time nature of neural electrical signal acquisition and the professionalism of stimulation strategy optimization, thereby improving the adaptability and effectiveness of neural modulation.

[0018] (4) The device adopts an overall design of wireless communication and electromagnetic coupling passive power supply, abandoning the complex wiring of traditional implantable devices. It combines an integrated cranial repair patch and an integrated implant structure to greatly improve the overall structural reliability of the device. At the same time, it simplifies the operation process of surgical implantation and postoperative external attachment, and improves the convenience of clinical use.

[0019] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of an implantable neuromodulation system suitable for traumatic brain injury according to Embodiment 1 of the present invention; Figure 2 This is a schematic diagram of the in vitro control patch structure according to Embodiment 1 of the present invention; Figure 3 This is a schematic diagram of the two sides of the skull repair patch in Embodiment 2 of the present invention; Figure 4 This is a schematic diagram of the inner structure of the cranial repair patch in Embodiment 2 of the present invention; Figure 5 This is a schematic diagram of the coupling structure between the in vitro control patch and the skull repair patch in Embodiment 2 of the present invention; Figure 6 This is a cross-sectional view of the coupling structure between the in vitro control patch and the skull repair patch in Embodiment 2 of the present invention; Figure 7 This is a schematic diagram of the induction coil circuit connection principle of Embodiment 1 of the present invention; Figure 8 This is a schematic diagram of the electrode array partitioning in Embodiment 1 of the present invention; Figure 9 This is a flowchart of a control method for an implantable neuromodulation system suitable for traumatic brain injury, according to Embodiment 3 of the present invention.

[0022] Figure Labels 10. Skull repair patch; 11. Edge threaded hole; 12. Mesh groove; 13. Hollow coupling screw; 15. Outer surface layer; 16. Three-dimensional mesh structure layer; 17. Inner bottom layer; 18. Through channel; 19. Cylindrical magnetic element; 20. Flexible substrate; 21. Induction coil; 22. Electrode array; 23. Thermal insulation protective layer; 30. External control patch; 31. Power cord; 32. Portable power supply; 33. Cable groove; 34. T-hole; 35. T-shaped magnetic element. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0024] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0025] Example 1 This embodiment provides an implantable neuromodulation system suitable for traumatic brain injury, mainly comprising an implant and an external control patch 30. The system's working principle is as follows: Figure 1 As shown.

[0026] The implant includes a flexible substrate 20. Multiple stimulation electrodes, arranged in a mesh or array, are integrated on the flexible substrate 20, forming an electrode array 22. Each stimulation electrode is directly electrically connected to an induction coil 21, forming a one-to-one correspondence. All induction coils 21 are connected to a common energy conversion circuit. The implant also contains an implantable microcontroller and a first wireless communication module. Both the energy conversion circuit and the first wireless communication module are electrically connected to the implantable microcontroller, which coordinates data acquisition, communication, and basic logic processing. A heat-insulating protective layer 23 is provided on the side of the implant closest to the human body, covering the surface of the induction coils 21 to prevent heat emitted from affecting the human body. The heat-insulating protective layer 23 exposes the electrode array 22, facilitating direct contact between the electrode array 22 and the human body.

[0027] The implant is specifically designed with two selectable implantation structures to suit different surgical needs.

[0028] The first form is an independent flexible mesh structure. The electrode array 22, induction coil 21, energy conversion circuit, implantation controller, and communication module are all integrated and distributed on the flexible mesh substrate 20, forming a complete independent device that can conform to the curvature of the skull. In craniocerebral injury surgery, after completing the necessary intracranial treatment, the mesh implant is placed and fixed between the scalp and the outer surface of the skull in the same operation, ensuring that its electrode array 22 covers the projection position of the target brain functional area.

[0029] The second form is a functional layer integrated structure. This form is suitable for cases requiring simultaneous cranioplasty. In this form, the implant, namely the flexible base 20 and all its integrated components, is pre-embedded and fixed onto a customized cranioplasty patch 10 as a complete functional layer. Specifically, a mesh-like distribution of grooves is formed on the surface of the patch body near the dura mater through precision machining, and the functional layer is fitably embedded and fixed within these grooves. Finally, the cranioplasty patch 10, with the implant integrated, is installed to the cranioplasty defect through the fixing holes on its edges, achieving a one-time completion of cranioplasty repair and stimulator implantation.

[0030] like Figure 2 As shown, the external control patch 30 has a groove 33 on its outer surface, through which a power line 31 passes. One end of the power line 31 is connected to a portable power supply 32, and the other end is connected to a distributed transmitting coil inside the patch. The transmitting coils are located in a matrix-distributed groove inside the patch. The external control patch 30 also integrates a multi-channel drive circuit, an external microcontroller, and a second wireless communication module. Each coil in the transmitting coil array is connected to an independent channel of the drive circuit, and both the drive circuit and the second wireless communication module are connected to the external microcontroller. In use, the external control patch 30 is attached to the patient's scalp, and its second wireless communication module establishes a bidirectional wireless data connection with the first wireless communication module implanted in the body. At the same time, the transmitting coil array of the external control patch 30 needs to be spatially aligned with the array of induction coils 21 implanted in the body to establish an effective electromagnetic coupling channel for wireless power supply to the implant.

[0031] The external control patch 30 communicates with a programmable terminal, allowing doctors to configure parameters and patients to monitor device status, including receiving warning messages from the external control patch 30, through the programmable terminal. The programmable terminal supports log access and programmable drivers.

[0032] like Figure 8As shown, the electrode array 22 in the implant is divided into multiple independent control zones, each containing at least one electrode. Each electrode in each zone forms an independent connection branch with its dedicated induction coil 21 and energy conversion circuit. All independent branches are electrically connected to the implant controller, enabling differentiated stimulation control of the electrodes in different zones. The circuit connection principle of the induction coil 21 is as follows... Figure 7 As shown.

[0033] A temperature sensor is integrated on the flexible substrate 20 of the implant, and the temperature sensor is electrically connected to the implant controller; a temperature sensor is also provided inside the shell of the external control patch 30, and it is electrically connected to the external controller; when the temperature detected by any temperature sensor exceeds the preset safety threshold, the external controller reduces the driving power of the corresponding channel or stops the driving output through the driving circuit, and at the same time triggers the first wireless communication module and the second wireless communication module to synchronously provide safety warning information.

[0034] The technical advantage of this embodiment is that by providing two distinct implantation forms, the system can flexibly adapt to different clinical scenarios where cranioplasty is required or not, ensuring that implantation can be completed during the original surgery for traumatic brain injury, avoiding the risks of secondary surgery and treatment delays, and realizing early intervention of neuromodulation.

[0035] Example 2 This embodiment provides a detailed description of the cranial repair patch 10 and key coupling structures involved in the second form of Embodiment 1.

[0036] like Figure 3 and Figure 4 As shown, the skull repair patch 10 is integrally manufactured from biocompatible materials such as medical titanium alloy or polyetheretherketone using 3D printing technology. Its main body is a plate structure with a certain thickness, including an inner bottom layer 17 near the dura mater, a three-dimensional mesh structure layer 16 in the middle, and an outer surface layer 15. Several edge threaded holes 11 are provided around the skull repair patch 10 to fix it to the recipient's skull. On the inner bottom layer 17 near the dura mater, precisely arranged mesh grooves 12 are machined to embed and securely accommodate the implant's functional layer. The contour of the mesh grooves 12 is adapted to the flexible base 20 of the implant, and the depth of the mesh grooves 12 matches the thickness of the implant's functional layer.

[0037] To achieve efficient penetration of external wireless energy through the patch material and coupling to the implant, the cranial repair patch 10 is designed with a core matrix-like through-channel structure 18. These channels penetrate the patch body in an array, and their spatial position is precisely aligned with each stimulation electrode and its associated induction coil 21 in the functional layer of the underlying implant. A hollow coupling screw 13 made of polyetheretherketone (PEEK) is screwed into each through-channel 18. PEEK has excellent biocompatibility and mechanical strength, while producing almost no interference to electromagnetic wave penetration.

[0038] After the hollow coupling screw 13 is screwed in, its internal cavity and the patch body together form a physical channel from the outer surface of the patch to the inner implant. This channel has multiple functions: its primary function is to achieve positioning and coupling, providing precise physical guidance for the transmitting coil of the externally controlled patch 30, so that the electromagnetic energy emitted can be efficiently coupled to the internal induction coil 21 through the channel, thus cleverly solving the problem of shielding wireless energy by metal or polymer patch. Secondly, this channel provides an additional heat dissipation path, which helps to dissipate the heat generated by the implant. In addition, the channel is also tunable. By screwing in or out the polyetheretherketone hollow coupling screw 13 to change its depth, the coupling distance between the transmitting and receiving coils can be finely adjusted, thereby non-invasively fine-tuning the stimulation intensity of the corresponding electrode channel after surgery.

[0039] To further improve the convenience and accuracy of daily application of external patches, a positioning calibration structure is provided between the external control patch 30 and the skull repair patch 10 to realize and maintain the alignment coupling between the transmitting coil array and the induction coil 21; the positioning calibration structure includes at least one of a physical alignment unit and an offset sensing unit.

[0040] The physical alignment unit employs a built-in magnetic attraction structure or a surface magnetic attraction structure.

[0041] like Figure 5 and Figure 6 As shown, the built-in magnetic structure includes a T-shaped magnetic element 35 disposed in the external control patch 30 and a cylindrical magnetic element 19 disposed inside the hollow coupling screw 13. A plurality of T-shaped holes 34 are distributed in the external control patch 30, and the T-shaped holes 34 are positioned opposite to the through channel 18. The T-shaped elements are embedded within the T-shaped holes 34. The T-shaped magnetic elements 35 and the cylindrical magnetic elements 19 are mutually attracted and aligned, so that the external control patch 30 is stably fixed to the outside of the skull. The transmitting coil and the induction coil 21 correspond one-to-one, stably generating current to power the electrodes.

[0042] The surface magnetic attraction structure includes several sets of magnetic attraction units. Each set of magnetic attraction units consists of a magnetic attraction element and its corresponding non-magnetic attraction element. The magnetic attraction element and the non-magnetic attraction element are respectively embedded on the surface of the external control patch 30 and the patch that are close to each other.

[0043] The offset sensing unit is a Hall sensor, inertial measurement unit, or optical positioning mark integrated on the external control patch 30 and / or the cranial repair patch 10, used to detect the alignment offset and feed it back to the external controller for coupling compensation.

[0044] The technical advantage of this embodiment lies in its innovative design of a matrix-style through-channel 18 and an adjustable hollow coupling screw 13, which deeply integrates cranioplasty and wireless neuromodulation. This structure effectively overcomes the technical obstacle of achieving stable wireless energy transmission in the context of implantable repair materials, ensuring the reliability of long-term treatment. The adjustable screw design provides flexibility for non-invasive adjustment of stimulation parameters postoperatively, enhancing the personalization of treatment. Simultaneously, a positioning and calibration structure is included to effectively guide patients or caregivers to quickly and accurately place the external patch at the target location, ensuring the normal operation of the induction coil 21.

[0045] Example 3 This embodiment describes the method flow for controlling the above system to perform closed-loop neural modulation, such as... Figure 9 As shown. This method is accomplished collaboratively by an implant microcontroller and an external patch microcontroller.

[0046] S1. Signal Acquisition and Transmission. The implant continuously acquires neurophysiological signals from the target brain region through its distributed stimulation electrodes. After preliminary amplification and filtering, the acquired raw signals are transmitted to the external control patch 30 via the implant microcontroller and the first wireless communication module. For simple features requiring extremely low latency processing, local real-time analysis can also be performed by the implant microcontroller.

[0047] S2. Feature Analysis and Event Judgment. The external microcontroller performs in-depth digital processing on the received neural signals. Processing methods include time-domain analysis to detect specific waveforms and frequency-domain transformation to calculate energy characteristics of specific frequency bands. The system compares the extracted feature values ​​with pre-stored thresholds or discrimination models within the controller to determine whether a predefined target neural event, such as the onset of epileptiform discharges, has occurred.

[0048] S3. Strategy Matching and Parameter Mapping. Once the system confirms the occurrence of a target neural event, it immediately retrieves a target stimulation strategy matching the event type from its built-in stimulation strategy library. The strategy library contains preset schemes for different scenarios, such as inhibitory strategies to suppress abnormal discharges or enhancement strategies to complement rehabilitation training. Based on the selected strategy, the system determines one or more target electrode zones to be activated, as well as the target stimulation intensity parameters required for each target electrode. Subsequently, using a preset mapping algorithm, these bioelectric stimulation parameters are converted into specific electrical parameters for the corresponding driving channels in the external control patch 30.

[0049] S4. Stimulation Execution and Dynamic Compensation. Based on the mapped parameters, the external microcontroller instructs the multi-channel drive circuit to operate, driving the corresponding transmitting coil to emit electromagnetic energy. The energy is wirelessly coupled and received by the corresponding induction coil 21 on the implant, then processed by the energy conversion circuit to generate precise electrical stimulation pulses applied to the target brain tissue. During this process, the system continuously monitors the coupling efficiency of each energy transmission channel, for example, by monitoring the reflected impedance or the receiving voltage. Simultaneously, the system can use an integrated alignment offset sensing unit to monitor the patch position. Once coupling attenuation or alignment deviation caused by patient movement is detected, the external microcontroller dynamically adjusts the driving power of the corresponding channel in real time to compensate for the attenuation, ensuring that the actual stimulation intensity applied to the brain tissue remains stable near the preset target value.

[0050] S5. Closed-Loop Assessment and Adaptive Adjustment. After applying stimulation, the system returns to step S1 at a set interval to collect post-stimulation neural signals to assess the intervention effect. Based on the information from this closed-loop feedback, the system can automatically optimize and adjust subsequent stimulation strategies, such as gradually reducing the stimulation intensity based on the treatment effect, or switching to a more suitable strategy mode, thereby achieving individualized and adaptive optimization of treatment parameters. Throughout the process, an independent safety monitoring module continuously operates. If faults such as excessive temperature, abnormal current, or communication interruption are detected, a predetermined safety protocol will be immediately triggered, such as reducing power or stopping stimulation, to ensure patient safety.

[0051] The technical advantage of this embodiment lies in realizing a fully automated, adaptive closed-loop control process, from neural signal perception and intelligent event recognition to precise stimulus output and real-time compensation, and finally to effect evaluation and strategy optimization. This method not only enables rapid response and intervention to pathological neurological events but also collaborates with rehabilitation training plans to provide time-precise auxiliary treatment. Its built-in dynamic compensation mechanism ensures the stability of treatment effects in daily life environments, while comprehensive safety monitoring constructs a reliable risk control system.

[0052] The remaining technical features in the above embodiments can be flexibly selected by those skilled in the art to meet different specific practical needs according to actual circumstances. Modifications and variations made by those skilled in the art that do not depart from the spirit and scope of the present invention should be within the protection scope of the appended claims. In the above description, numerous specific details have been set forth to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that these specific details are not necessary to implement the present invention. In other instances, to avoid obscuring the present invention, well-known techniques, such as specific construction details, operating conditions, and other technical conditions, have not been specifically described.

[0053] This document uses specific examples to illustrate the principles and implementation methods of the present invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of the present invention. Furthermore, those skilled in the art will recognize that, based on the ideas of the present invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of the present invention.

Claims

1. An implantable neuromodulation system suitable for traumatic brain injury, characterized in that, Including implants and external control patches; The implant includes: a flexible substrate, and an electrode array, an induction coil, an energy conversion circuit, an implantation controller, and a first wireless communication module integrated on the flexible substrate; the electrode array and the induction coil are electrically connected in a one-to-one correspondence, each of the induction coils is electrically connected to the energy conversion circuit, and the energy conversion circuit and the first wireless communication module are respectively electrically connected to the implantation controller; The implant has two integrated structural forms: a) An independent flexible mesh structure, in which the electrode array, induction coil, energy conversion circuit, implantation controller and first wireless communication module are integrated on a flexible mesh substrate; b) Functional layer integrated structure, the flexible substrate and the integrated components together constitute the functional layer, which is embedded and fixed in the preset mesh groove on the side of the skull repair patch body near the dura mater, and fixed to the defect site of the skull along with the skull repair patch through the edge threaded hole. The external control patch is provided with a transmitting coil array, a driving circuit, an external controller, and a second wireless communication module; a plurality of transmitting coils constituting the transmitting coil array are electrically connected to the driving circuit in a one-to-one correspondence, and the driving circuit and the second wireless communication module are electrically connected to the external controller respectively; the second wireless communication module establishes a wireless communication connection with the first wireless communication module, and the transmitting coil array corresponds to the induction coil in a one-to-one correspondence, forming an electromagnetic coupling connection.

2. The implantable neuromodulation system for traumatic brain injury according to claim 1, characterized in that: The skull repair patch body is integrally molded from titanium alloy or polyetheretherketone material, including an inner bottom layer near the dura mater, a three-dimensional mesh structure layer in the middle, and an outer surface layer. The mesh groove is formed on the side of the inner bottom layer facing the dura mater. The outline of the mesh groove is adapted to the flexible base of the implant, and the depth of the mesh groove matches the thickness of the functional layer of the implant. The skull repair patch body also has several through channels distributed in a matrix corresponding to the positions of the electrode array.

3. The implantable neuromodulation system for traumatic brain injury according to claim 2, characterized in that: The inner wall of the through channel is provided with internal threads to accommodate hollow coupling screws made of polyetheretherketone (PEEK). The induction coil is fitted around the periphery of the through channel. The axis of the hollow coupling screw is collinear with the central axis of the corresponding induction coil. The transmitting coil array is distributed and aligned with the induction coil. The induction coil is covered with a heat-insulating protective layer.

4. An implantable neuromodulation system for traumatic brain injury according to claim 3, characterized in that: A positioning and calibration structure is provided between the external control patch and the skull repair patch to achieve and maintain the alignment coupling between the transmitting coil array and the inductive coil; the positioning and calibration structure includes at least one of a physical alignment unit and an offset sensing unit. The physical alignment unit adopts a built-in magnetic attraction structure or a surface magnetic attraction structure; The built-in magnetic structure includes a T-shaped magnetic element disposed in the external control patch and a cylindrical magnetic element disposed inside the hollow coupling screw. A plurality of T-shaped holes are distributed in the external control patch. The T-shaped holes are arranged opposite to the through channel. The T-shaped elements are embedded in the T-shaped holes. The T-shaped magnetic elements and the cylindrical magnetic elements are attracted to each other and aligned. The surface magnetic attraction structure includes several sets of magnetic attraction units. Each set of magnetic attraction units consists of a magnetic attraction element and its corresponding non-magnetic attraction element. The magnetic attraction element and the non-magnetic attraction element are respectively embedded on the surfaces of the external control patch and the patch that are close to each other. The offset sensing unit is a Hall sensor, inertial measurement unit, or optical positioning mark integrated on the external control patch and / or the cranial repair patch, used to detect the alignment offset and feed it back to the external controller for coupling compensation.

5. An implantable neuromodulation system for traumatic brain injury according to claim 1, characterized in that: The electrode array is divided into multiple independent control zones, each containing at least one electrode. The electrodes in each zone form independent connection branches with dedicated induction coils and energy conversion circuits. All independent branches are electrically connected to the implanted controller to achieve differentiated stimulation control of electrodes in different zones.

6. An implantable neuromodulation system for traumatic brain injury according to claim 1, characterized in that: The implanted controller and the external controller establish a bidirectional data synchronization connection through the first wireless communication module and the second wireless communication module to form a collaborative control architecture. The implanted controller is electrically connected to the electrode array and is responsible for the initial acquisition, preprocessing and rapid stimulation triggering of neurophysiological signals. The external controller is electrically connected to the drive circuit and is responsible for complex signal feature analysis, stimulation strategy optimization and adaptive power supply adjustment. The implanted controller and the external controller coordinate the output of control commands through data synchronization.

7. An implantable neuromodulation system for traumatic brain injury according to claim 1, characterized in that: A temperature sensor is integrated on the flexible substrate of the implant, and the temperature sensor is electrically connected to the implantation controller; a temperature sensor is also provided inside the shell of the external control patch, and it is electrically connected to the external controller; the external controller is configured to: when the temperature detected by any temperature sensor exceeds a preset safety threshold, reduce the driving power of the corresponding channel or stop the driving output through the driving circuit, and at the same time trigger the first wireless communication module and the second wireless communication module to synchronously provide safety warning information.

8. An implantable neuromodulation system for traumatic brain injury according to claim 1, characterized in that: A storage unit is integrated on the flexible substrate of the implant, and the storage unit is electrically connected to the implant controller. The storage unit is used to store a preset stimulation strategy library, a neural event log, and system operating parameters. The neural event log includes event timestamps, trigger feature data, executed stimulation parameters, and safety event records, and is transmitted to an external device through a first wireless communication module and a second wireless communication module.

9. A control method for an implantable neuromodulation system suitable for traumatic brain injury, as described in any one of claims 1-8, characterized in that, Includes the following steps: Signal acquisition and transmission steps: Electrophysiological signals of the target brain region are acquired through the electrode array of the implant, and the signals are transmitted to the implant controller via the electrode array, or to the external controller via the first wireless communication module and the second wireless communication module. Feature analysis and event judgment steps: The implanted controller and / or external controller preprocess the signal and extract features to obtain at least one feature index. The feature index is compared with a preset threshold to determine whether a target neural event has occurred. Stimulation strategy decision-making steps: When a target neural event is determined to have occurred, a target stimulus strategy is selected from a pre-stored stimulus strategy library based on the event type and / or spatial location information. Stimulation parameter mapping and output steps: Determine the target stimulation intensity of the target electrode according to the target stimulation strategy, and map it to the driving parameters of the corresponding emission channel of the external control patch. The external controller drives the emission coil array to output energy through the driving circuit, which is transmitted to the induction coil through electromagnetic coupling, and then converted into stimulation current through the energy conversion circuit and output by the target electrode. Closed-loop feedback and adjustment steps: During or between stimulation outputs, the signal acquisition and transmission steps are repeated. Based on new neurophysiological signals and / or system state parameters, the target stimulation strategy and / or driving parameters are dynamically adjusted to form closed-loop control.

10. The control method for an implantable neuromodulation system suitable for traumatic brain injury according to claim 9, characterized in that, The target neural events include epileptiform discharge events and / or training trigger signals transmitted by external rehabilitation devices and user interfaces; the stimulation strategy library includes inhibitory electrical stimulation strategies and enhancing electrical stimulation strategies, which correspond to two types of target neural events, respectively, wherein the enhancing electrical stimulation strategies are adapted to the regulation of motor function-related brain regions within a preset time window.

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