Brain-computer interface implantable device for epilepsy closed-loop regulation and control

Abstract

The invention relates to the technical field of medical instruments and brain-computer interfaces, in particular to a brain-computer interface implantable device for epilepsy closed-loop regulation and control, which comprises an implantation shell, an implantation unit, a shaft rod, a roller, a clamping block and a movement limiting mechanism. Through the dual redundancy sealing design of dynamic sealing and second-stage dynamic sealing of a metal and ceramic full-sealing main body shell welded through laser and a corrugated pipe, the industrial problem that a movable implantation component faces body fluid permeation for a long time is solved, and sensitive electronic elements are completely sealed in a dry inert environment through the design; the safe and stable operation of the core processing system in the human body in the life cycle of tens of years is ensured; abstract imaging depth data are converted into specific, adjustable and visible mechanical backstops on the device by moving the limiting mechanism, and precise thread transmission is combined, so that the final implantation depth of an electrode contact can be accurately preset before an operation, mechanical guarantee is achieved in the operation, and depth errors caused by traditional dependence on the hand feeling and experience of an operator are eliminated.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices and brain-computer interface technology, in particular to a brain-computer interface implantable device for closed-loop regulation of epilepsy. BACKGROUND

[0002] Epilepsy is a chronic neurological disease caused by abnormal and synchronous excessive firing of neurons in the brain, affecting millions of patients worldwide. Electroencephalogram (EEG) is the most commonly used and effective method for detecting and locating epileptic lesions. For patients with drug-resistant epilepsy, surgical treatment is a possible cure, but it has limitations such as large trauma and strict indications. Therefore, as a reversible and regulatory treatment method, neural regulation technology has become an important alternative or supplementary treatment method, and closed-loop neural regulation represents the forefront of this field. The core of the closed-loop neural regulation system is to achieve a real-time autonomous cycle of "monitoring-decision-intervention". It continuously monitors brain electrical activity through implantable electrodes, uses built-in or external algorithms for real-time analysis, and automatically triggers electrical stimulation for intervention when detecting the onset or precursor signals of seizures, thereby suppressing abnormal firing before clinical symptoms appear. Compared with traditional open-loop stimulation, the closed-loop system has potential advantages such as on-demand treatment, fewer side effects, and more precise efficacy.

[0003] However, implementing a long-term, stable, and reliable closed-loop brain-computer interface implantable system faces a series of severe technical challenges: Long-term sealing problem: In order to implement precise closed-loop regulation, the electrode part of the implantable device must maintain physical contact with brain tissue, while the precise electronic components that process signals need to be strictly sealed and protected from corrosive body fluids. Traditional fixed sealing structures cannot meet the needs of implantable devices with moving parts. The dynamic interface between moving parts and the housing is the main pathway for body fluid penetration, and long-term sealing failure will directly lead to corrosion and damage of the electronic system, resulting in the failure of the entire treatment and even causing serious complications. Implantation precision and stability challenge: The depth and location of the electrode contacts in the brain directly affect the signal quality and stimulation effect. Existing implantation methods rely heavily on the experience and feel of the surgeon, making it difficult to ensure precision and individual differences. At the same time, the long-term fixation of the device in the skull usually relies on screws or bone anchors that pass through the skull, which not only increases the risk of surgical trauma, bleeding, and infection, but also the long-term stability of the screws is affected by bone integration, and there is a possibility of loosening. For closed-loop systems, any small displacement of the electrode can lead to signal distortion or stimulation target deviation, severely affecting the efficacy. System integration and reliability requirements: A complete closed-loop system needs to integrate multiple subsystems such as signal acquisition, processing, stimulation, wireless communication and power supply; it is a great engineering challenge to achieve high integration in extremely limited intracranial implant space and ensure the long-term stable work of each subsystem in complex in vivo environment; the long-term reliability of the system directly determines the safety and effectiveness of the treatment; In the prior art, there have been some improvements on epilepsy electrode implant devices; for example, patent CN110917493B discloses an epilepsy electrode implant device, which drives the clamping block to extend through the up-and-down movable electrode device, realizes intracranial anchoring without screws, simplifies the implantation process and reduces trauma; this patent has contributed to mechanical fixation and convenient operation; however, this scheme mainly focuses on the convenience of mechanical fixation in the early stage of implantation and does not involve the dynamic sealing problem of long-term implantation, nor does it integrate the core intelligent processing unit, wireless communication module and long-acting power supply necessary for closed-loop regulation; its essence is a passive and mechanical implant carrier that cannot independently complete signal analysis and adaptive stimulation; therefore, developing an integrated implantable device that can simultaneously solve the problems of long-term dynamic sealing, realize precise implantation and stable fixation, and highly integrate intelligent closed-loop regulation functions has become a key technical problem that needs to be broken through in the field. SUMMARY

[0004] The purpose of the present application is to provide a brain-computer interface implantable device for epilepsy closed-loop regulation, which not only inherits the advantages of easy implantation and removal of the previous generation, but also realizes closed-loop regulation and solves the sealing problem of long-term implantation.

[0005] In a first aspect, the brain-computer interface implantable device for epilepsy closed-loop regulation provided by the present application adopts the following technical scheme: an implantable shell, an implant unit, a shaft, a roller, a clamping block, and a movement limiting mechanism; the implantable shell is composed of a lower biocompatible metal base and an upper ceramic sealing cover to form a fully sealed cavity by laser welding, the biocompatible metal base is used to be fixed in the hole of the skull, and a cavity is arranged inside; the implant unit is movably arranged in the cavity, a static sealing ring one is fixedly embedded in the annular groove at the entrance of the cavity, the lower end of the static sealing ring one is sealingly connected with a corrugated pipe sealing element, the implant unit includes a column, a connecting plate, a static sealing ring two, a sealing piston, an electrode contact, an internal power supply, a core processing chip, and a wireless communication module; the lower end of the column is sleeved with the sealing piston, the sealing piston is embedded with the static sealing ring two for dynamic sealing with the inner wall of the cavity, the sealing piston is dynamically sealed with the inner wall of the cavity, the upper end of the column is fixed with the connecting plate, the bottom of the column is connected with the electrode contact, and the lower end of the column is conical.

[0006] By adopting the technical scheme, a highly integrated and excellent sealing implantable device core is constructed, the laser-welded metal-ceramic shell constitutes a firm and biocompatible sealing main body, which provides a long-term stable protection environment for internal precise electronic components, and the innovative static sealing ring, bellows sealing element and sealing piston dynamic sealing system can effectively isolate the penetration of body fluid and tissue when the implant unit moves up and down in the cavity to perform functions, thereby ensuring the safety and reliability of the device during long-term implantation.

[0007] Preferably, the lower end of the biocompatible metal base is provided with a hole slot, the hole slot is communicated with the cavity, a clamping block and a shaft are arranged in the hole slot, a roller is arranged on the shaft, a sliding hole is arranged on the clamping block, the roller passes through the sliding hole, a through hole is arranged on the lower end surface of the biocompatible metal base, the lower end of the electrode contact passes through the through hole, and the cone at the lower end of the column can push the clamping block to protrude out of the hole.

[0008] By adopting the technical scheme, a clever and reliable intracranial anchoring mechanism is provided, when the implant unit moves downward, the cone at the lower end of the column extrudes the rear end of the clamping block, and the front end of the clamping block is pushed out of the hole slot in the radial direction by using the inclined surface principle, so that the clamping block is tightly abutted against the dura mater or the inner plate of the skull, thereby realizing stable fixation of the device without the need for additional screws, greatly reducing surgical trauma and fixation time, and the cooperation of the roller and the sliding hole converts sliding friction into rolling friction, so that the protrusion and retraction of the clamping block are more smooth.

[0009] Preferably, the ceramic sealing cover constitutes an antenna window, and the antenna of the wireless communication module is arranged below the antenna window.

[0010] By adopting the technical scheme, the ceramic material has excellent penetration to radio signals, and is used as an antenna window, which can maintain the overall sealing of the shell, ensure the efficiency and stability of data and energy transmission between the wireless communication module and external equipment, and avoid the metal shielding effect.

[0011] Preferably, the column is internally integrated with a built-in power supply, a core processing chip and a wireless communication module, the core processing chip is electrically connected with the built-in power supply and the wireless communication module, the core processing chip includes a microprocessor pre-stored with an epilepsy characteristic signal recognition algorithm and a stimulation generation circuit, which are used to realize closed-loop regulation, and the upper end surface of the connecting plate is provided with a docking structure for cooperating with a surgical tool.

[0012] By adopting the technical scheme, the three core electronic systems of power supply, processing and communication are highly integrated in the column, the miniaturization and modularization of the device are realized, the core processing chip endows the device with the closed-loop autonomous ability of perception, decision and action, the brain electrical signals can be analyzed in real time and the electric stimulation is automatically triggered when the premonitory symptom of epilepsy is identified, and the docking structure on the connecting plate facilitates the accurate and safe implantation and removal operation in the operation.

[0013] Preferably, the moving limiting mechanism comprises a movable column, a moving plate, a limiting rod, a screw rod, a fitting plate and a guide rod, the bottom of the movable column is fixed with the ceramic sealing cover, the movable column is in threaded cooperation with the inner side of the moving plate, the upper end edge of the moving plate is fixed with the limiting rod, the right end of the screw rod is in threaded connection with the ceramic sealing cover, the bottom of the screw rod is connected with the fitting plate, the fitting plate is fixed with the lower end of the guide rod, the guide rod is in sliding cooperation with the left end of the ceramic sealing cover, the upper end of the limiting rod is in contact with the connecting plate, and the column penetrates the middle part of the movable column.

[0014] By adopting the technical scheme, the moving limiting mechanism provides accurate control and locking function for the stroke of the implanted unit, the fitting plate and the guide rod can be driven to move up and down as a whole by rotating the screw rod, and the initial height of the moving plate and the limiting rod can be adjusted, which is equivalent to presetting the final position of the downward movement of the implanted unit, that is, the implantation depth of the electrode contact, realizing the predictability and accuracy of the operation, and the contact between the limiting rod and the connecting plate plays a reliable mechanical limiting role.

[0015] Preferably, the inner wall of the movable column is provided with a first thread, and the first thread is matched with a second thread on the outside of the column.

[0016] By adopting the technical scheme, the rotating motion of the connecting plate is converted into the accurate linear motion of the column through the threaded pair transmission, and the transmission mode is accurate in control and good in self-locking, which can ensure that the implanted unit remains stable after reaching the predetermined position and will not loosen due to brain pulsation and other external forces, thereby ensuring the continuity of treatment and monitoring.

[0017] Preferably, the moving limiting mechanism further comprises a compression spring and a limiting buckle, the left end of the compression spring is fixed with the inside of the moving plate, and the right end of the compression spring is fixed with the limiting buckle.

[0018] By adopting the technical scheme, an automatic locking and anti-loosening mechanism is added, the compression spring provides continuous pre-tightening force for the limiting buckle to ensure that it can reliably act when locking is needed.

[0019] Preferably, the bellows seal is made of biocompatible elastic material.

[0020] By adopting the above technical scheme, the biocompatibility of the dynamic sealing component and the human tissue is ensured, and the rejection reaction is avoided, and the elasticity of the material ensures the fatigue life and sealing reliability of the bellows in the repeated stretching and contraction process.

[0021] Preferably, the compression spring and the limit buckle are provided in two groups and are arranged opposite to each other along the left and right sides of the moving plate, the cross section of the limit buckle is in the shape of a hook, and the limit buckle is in sliding fit with the inner side of the moving plate, when the connecting plate is moved to be in close contact with the limit rod, the limit buckle can be buckled on the connecting plate to limit the connecting plate.

[0022] By adopting the above technical scheme, the symmetrical and balanced locking force provided by the double limit buckles effectively prevents the unilateral lifting or accidental rotation and loosening of the connecting plate, when the connecting plate is lowered to be in contact with the limit rod, i.e., reaches the preset depth, the limit buckle is automatically buckled under the action of the compression spring, forming secondary mechanical locking, which greatly enhances the position stability of the entire implant unit in long-term use, and is a key safety measure to ensure long-term effective treatment.

[0023] To sum up, the present application includes at least one of the following beneficial technical effects of the brain-computer interface implantable device for closed-loop regulation of epilepsy: 1. The double-redundant sealing design of the metal and ceramic full-sealed main shell by laser welding, the dynamic sealing of the bellows, and the second dynamic sealing solves the industry problem that the movable implantable component is long-term exposed to body fluid penetration, the design completely encloses sensitive electronic elements in a dry inert environment, ensuring the safe and stable operation of the core processing system in the human body for decades of life cycle, which is the physical basis for realizing long-term effective closed-loop regulation; 2. The abstract imaging depth data is converted into specific, adjustable and visible mechanical stops on the device by the moving and limiting mechanism, and combined with precise screw transmission, so that the final implantation depth of the electrode contact can be accurately preset before operation and mechanically guaranteed during operation, eliminating the depth error caused by the traditional reliance on the operator's sense and experience, and realizing standardized and repeatable high-precision implantation; 3. The rotation screw rod moves the abutting plate to the lower end to abut the skull, reduces the pore between the ceramic sealing cover and the skull, and makes the biocompatible metal base and the ceramic sealing cover and the skull stable and firm. 4. The automatic buckling mechanism forms a reliable secondary mechanical locking, which can effectively prevent the connecting plate from rotating or moving upward due to brain tissue pulsation, micro-vibration or accidental external force during long-term implantation, thereby eliminating the risk of electrode contact position drift or clamping anchor loosening, and the symmetrical design of the double limit buckles provides balanced locking force, avoiding the deflection caused by unilateral force, which is a key safety measure to ensure the continuous and stable operation of the device in the life cycle of several years to several decades of the patient. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 is the overall structure schematic diagram of embodiment 1 of the present application; Figure 2 is Figure 1 is the local enlarged schematic diagram of part A of Figure 3 is the internal structure schematic diagram of the implant unit of embodiment 1 of the present application; Figure 4 is the device mounting structure schematic diagram of embodiment 1 of the present application; Figure 5 is the moving limiting mechanism structure schematic diagram of embodiment 1 of the present application; Figure 6 is the overall structure schematic diagram of embodiment 2 of the present application; Figure 7 is the moving limiting mechanism structure schematic diagram of embodiment 2 of the present application.

[0025] In the figure: implant shell-1, implant unit-2, shaft-3, roller-4, clamping block-5, moving limiting mechanism-6, biocompatible metal base-11, ceramic sealing cover-12, cavity-13, hole groove-14, static sealing ring-15, bellows seal-16, column-21, connecting plate-22, static sealing ring-23, sealing piston-24, electrode contact-25, built-in power supply-26, core processing chip-27, wireless communication module-28, movable column-61, moving plate-62, limiting rod-63, screw-64, fitting plate-65, guide rod-66. DETAILED DESCRIPTION

[0026] The following will be described in detail in combination with the accompanying Figure 1 - the accompanying Figure 7 , the present application will be further described in detail.

[0027] Embodiment 1: a brain-computer interface implantable device for closed-loop regulation of epilepsy, referring to Figures 1-5 , comprising an implant shell 1, an implant unit 2, a shaft 3, a roller 4, a clamping block 5, and a moving limiting mechanism 6; the implant shell 1 is the main support and sealing structure of the device, the lower part is a biocompatible metal base 11, for example, using medical grade titanium alloy TC4, the upper part is a ceramic sealing cover 12, for example, using biocompatible alumina ceramic or zirconia ceramic, the biocompatible metal base 11 and the ceramic sealing cover 12 form a full-sealing rigid cavity with good air and liquid tightness through high-precision laser welding process, the biocompatible metal base 11 is used for implanting and fixing in the pre-drilled hole of the skull 7, the inside of the base 11 is provided with a cylindrical cavity 13, the shape and size of the biocompatible metal base 11 are designed according to the anatomical structure of the skull, for implanting and stably fixing in the pre-drilled circular implant hole of the skull 7; This metal-ceramic composite shell has the following advantages: mechanical strength and biocompatibility, titanium alloy base provides excellent mechanical strength and toughness, can withstand intracranial pressure and ensure long-term structural stability; its surface can be bioactivated to promote bone integration and enhance long-term fixation after implantation; the ceramic part has extremely stable chemical properties and excellent biological inertia; Electromagnetic signal penetration: the ceramic material has excellent wave permeability for radio electromagnetic signals such as radio frequency signals used for communication and wireless charging, with almost no loss, providing an ideal antenna window for the built-in antenna and avoiding the shielding effect of the metal shell on the signal; Long-term sealing reliability: the laser welding forms a dense and high-strength weld, which is the key technology to achieve long-term reliable sealing.

[0028] The implant unit 2, as the functional core of the device, is movably arranged in the cavity 13. In order to achieve absolute sealing of the implant unit 2 during movement and prevent body fluids from penetrating and eroding the internal electronic components, a static sealing ring I 15, such as a medical-grade silicone O-ring, is fixedly embedded in the annular groove at the entrance of the cavity 13. The lower end of the static sealing ring I 15 is sealingly connected with the upper edge of a bellows seal 16 made of biocompatible elastic material, such as medical-grade silicone. The lower edge of the bellows seal 16 is sealingly connected with a sealing piston 24 that is sleeved on the implant unit 2, thereby forming a retractable sealing barrier that completely physically isolates the electronic component cavity in the upper part of the cavity 13 from the mechanical transmission and tissue contact area in the lower part; The implant unit 2 specifically comprises a column 21, a connecting plate 22, a static sealing ring two 23, a sealing piston 24, an electrode contact 25, an internal power supply 26, a core processing chip 27 and a wireless communication module 28; the lower end of the column 21 is in a conical shape and is sleeved with the sealing piston 24; the sealing piston 24 is embedded with the static sealing ring two 23, such as a generic seal or a stellite seal, which is suitable for dynamic sealing of medical-grade sealing elements, so as to form a precise dynamic sealing fit with the inner wall of the cavity 13; the second dynamic sealing and the corrugated tube sealing above jointly constitute a redundant sealing, which greatly improves the long-term reliability; the up and down movement of the sealing piston 24 directly drags the corrugated tube sealing element 16 to compress or stretch like an accordion bellows; the key is that no matter the corrugated tube is in a compressed or stretched state, the wrinkle wall of the silica gel material always maintains a continuous and gapless sealing surface, which "absorbs" the linear motion of the sealing piston 24 into the elastic deformation of itself, so as to maintain the integrity of the first flexible barrier throughout the entire stroke, thereby preventing fluid from leaking along the axial direction; at the same time, the static sealing ring two 23 on the sealing piston 24 forms a precise sliding sealing pair with the inner wall of the cavity 13; this sealing serves as the second line of defense, mainly resisting the possible radial pressure difference and providing redundant protection; even in the case of microscopic fatigue of the corrugated tube, the dynamic sealing ring can still effectively block the penetration; the upper end of the column 21 is fixed with a disc-shaped connecting plate 22, and the bottom is connected with an electrode contact 25 for contacting the brain tissue; the electrode contact 25 is made of biocompatible conductive materials, such as platinum-iridium alloy and diamond-doped carbon fiber bundles, and the surface can be nano-structured to reduce interface impedance and improve signal quality; the electrode contact 25 can be a single contact or multiple array-distributed point or linear contacts for high-fidelity acquisition of local field potentials and / or application of precise electrical stimulation pulses; more importantly, the inside of the column 21 is integrated with an internal power supply 26, such as a micro solid-state battery, a core processing chip 27 and a wireless communication module 28; the core processing chip 27 is electrically connected with the internal power supply 26 and the wireless communication module 28, and contains a microprocessor with pre-stored epilepsy characteristic signal recognition algorithms, such as a pattern recognition algorithm based on a machine learning model, and a programmable stimulation generation circuit, thereby giving the device the ability of closed-loop regulation and control of signal acquisition, real-time analysis and automatic intervention; the upper end face of the connecting plate 22 is processed with a specific geometric docking structure, such as a cross slot, an internal hexagonal hole, a special-shaped bayonet, etc., for quick and non-slip engagement with sterile, disposable or reusable sterilizable special implant tools, such as a torque wrench; the wireless communication module 28 contains an ultra-low-power radio frequency transceiver chip, such as a custom protocol based on BLE 5.0 or lower power consumption, and a micro antenna matched therewith, which is responsible for bidirectional wireless communication with the external device, transmission of EEG data segments and event logs, and reception of parameter update instructions; Clamping and fixing mechanism: On the lower end side wall of the biocompatible metal base 11, at least one, usually 2-4, circumferentially distributed hole slots 14 are provided, which are communicated with the cavity 13; each hole slot 14 is provided with a clamping block 5 and a shaft 3; the shaft 3 is sleeved with a freely rotating roller 4, and the clamping block 5 is provided with a long strip-shaped sliding hole through which the roller 4 passes; when the column 21 of the implant unit 2 moves downward, the conical surface at the lower end will extrude the rear end of the clamping block 5, i.e. the end close to the center of the cavity, forcing the clamping block 5 to rotate around the contact point between the clamping block 5 and the hole slot, and the front end, i.e. the end away from the center of the cavity, will extend radially out of the hole slot 14, and finally tightly abut against the dura mater or the inner plate of the skull, thereby achieving reliable anchoring of the device in the intracranial cavity without the need for additional use of bone screws or screws; the design of the roller 4 converts the sliding friction between the clamping block 5 and the conical surface into rolling friction, making the extension and retraction action smoother and reducing wear and operating force; the electrode contact 25 passes through the through hole in the lower end surface of the base 11 and always maintains contact with the target brain area, and the outer side surface of the clamping block 5 is designed as a smooth arc or has anti-skid lines to increase the contact area and friction with the dura mater or the inner plate of the skull; Depth preset and limiting mechanism: The movement limiting mechanism 6 is used to preset and lock the final implantation depth of the implant unit 2; the mechanism includes a movable column 61, a moving plate 62, a limiting rod 63, a screw rod 64, a fitting plate 65 and a guide rod 66; the bottom of the movable column 61 is fixed on the ceramic sealing cover 12, and the inner wall thereof is processed with a first internal thread; the inner side of the moving plate 62 is processed with a thread matched with the outer diameter of the movable column 61, and the moving plate 62 can be moved up and down along the axial direction of the movable column 61 by rotating the moving plate 62; the upper end edge of the moving plate 62 is fixed with the limiting rod 63; the screw rod 64 is matched with the threaded hole on the right side of the ceramic sealing cover 12, and the bottom thereof is fixed with the lower end of the guide rod 66 through the fitting plate 65; the guide rod 66 is slidably matched with the guide hole on the left side of the ceramic sealing cover 12; in this way, rotating the screw rod 64 can drive the fitting plate 65 and the guide rod 66 to move up and down stably as a whole.

[0029] The implementation principle of the embodiment of the present application is: Preoperative preparation: Based on the preoperative image fusion data of the patient, the surgeon plans the accurate depth required by the electrode contact 25 to reach the target brain area, denoted as D, and on the sterile operating table, the operator first manually rotates the moving plate 62 to move it on the movable column 61 to approximately the scale corresponding to the depth D, and then accurately sets the top plane of the limiting rod 63 at a distance of D from the lower end surface of the base 11, and after the adjustment is completed, Device implantation: place the biocompatible metal base 11 of the implant housing 1 into the hole of the skull 7; at this time, the clamping block 5 is in the retracted state, and the whole is placed into the prepared bone hole of the skull 7, the fitting plate 65 at the lower end of the ceramic sealing cover 12 is attached to the outer plate of the skull, providing preliminary support, and by rotating the screw rod 64, the screw rod 64 drives the fitting plate 65 to move to the lower end, and is attached to the skull 7, reducing the gap between the ceramic sealing cover 12 and the skull 7, so that the biocompatible metal base 11 and the ceramic sealing cover 12 are stably installed on the skull 7; Electrode implantation and fixation: firmly engage the drive head of the sterile implant tool with the docking structure of the connecting plate 22, and rotate the tool clockwise at a constant and slow speed; due to the cooperation of the first internal thread of the movable column 61 and the second external thread on the outer side of the column body 21, the rotating motion is converted into the precise linear downward motion of the column body 21; the electrode contact 25 is then inserted downward through the through hole to contact the brain tissue; at the same time, the conical surface at the lower end of the column body 21 begins to push the rear end of the clamping block 5, causing the front end to gradually extend and anchor; Limiting and locking: when the lower surface of the connecting plate 22 descends to fully contact the upper surface of the pre-set limiting rod 63, a clear tactile feedback, a sudden increase in torque and / or visual confirmation will be generated, and the connecting plate 22 is flush with the limiting rod 63, which indicates that the implant unit 2 has accurately reached the pre-set depth D, and the clamping mechanism has also been positioned, at which point the rotation is immediately stopped; the threaded pair itself has good self-locking property, which can prevent reverse loosening due to slight vibration under normal conditions; at this point, the electrode implantation depth and device fixation are completed simultaneously; After the device is implanted and fixed, it enters a long-term working state; the electrode contact 25 continuously collects local brain electrical signals; after amplification and filtering by the ultra-low power consumption analog front end, the signals are digitized by the analog-to-digital converter in the core processing chip 27; the microprocessor runs real-time epilepsy feature recognition algorithms, such as lightweight neural networks, for online analysis of the signals; once the algorithm identifies specific electrophysiological patterns that indicate seizures, such as high-frequency oscillations and spiky rhythms, the processor immediately triggers the stimulation generation circuit to release a set of pre-set safe and effective biphasic charge balance electrical stimulation pulses through the same or adjacent electrode contacts 25 to the target brain area, aiming to break abnormal neural synchronization activity and thus prevent or reduce clinical seizures; the entire process is automatically completed within milliseconds to seconds, forming a real-time closed loop of perception, analysis, and intervention; at the same time, the wireless communication module 28 periodically or event-triggered communicates with the external device, uploads key data segments for the doctor to remotely evaluate the efficacy and optimize the parameters, and can also receive instructions from the outside or perform wireless energy replenishment.

[0030] Embodiment 2: A brain-computer interface implantable device for epilepsy closed-loop regulation, referring to Figures 6-7 , this embodiment further enhances the mobile limiting mechanism 6 based on embodiment 1, and adds an automatic anti-loosening locking function.

[0031] Specifically, the mobile limiting mechanism 6 further comprises compression springs 67 and limiting buckles 68. The compression springs 67 and the limiting buckles 68 are provided in two groups and symmetrically distributed inside the left and right sides of the mobile plate 62. One end of the compression spring 67 is fixed inside the mobile plate 62, and the other end is connected with the limiting buckle 68, providing a continuous pre-tightening force towards the center of the mobile plate 62. The cross section of the limiting buckle 68 is in the shape of a hook and can slide in the sliding groove inside the mobile plate 62.

[0032] When the connecting plate 22 is lowered during implantation, its lower surface gradually approaches and eventually fits the upper surface of the limiting rod 63, and when reaching the preset depth, the edges of the connecting plate 22 will squeeze and push away the inclined surfaces of the two limiting buckles 68. Once the connecting plate 22 completely passes the hook part of the limiting buckle 68, the two limiting buckles 68 will quickly slide inward under the restoring force of the compression spring 67, so that the hook part of the limiting buckle 68 automatically buckles on the edge of the upper surface of the connecting plate 22.

[0033] This automatic buckling mechanism forms a reliable secondary mechanical locking, which can effectively prevent the connecting plate 22 and the entire implant unit 2 from being slightly rotated or moved upward due to brain tissue pulsation, micro-vibration or accidental external force during long-term implantation, thereby eliminating the risk of electrode contact position drift or clamping anchor loosening. The symmetrical design of the two limiting buckles 68 provides balanced locking force and avoids the possibility of deflection caused by unilateral force, which is a key safety measure to ensure the continuous and stable operation of the device during the life cycle of several years to several decades of the patient.

[0034] The embodiments of the specific implementation are the preferred embodiments of the present application, but do not limit the protection scope of the present application, wherein the same parts are indicated by the same reference numerals. Therefore: any equivalent changes made according to the structure, shape, principle of the present application should be covered within the protection scope of the present application.

Claims

1. A brain-computer interface implantable device for closed-loop regulation of epilepsy, characterized in that: The implant includes an implant housing (1), an implant unit (2), a shaft (3), a roller (4), a clamping block (5), and a moving limiting mechanism (6). The implant housing (1) is a fully sealed cavity formed by laser welding of a lower biocompatible metal base (11) and an upper ceramic sealing cap (12). The biocompatible metal base (11) is used to fix the implant in the hole of the skull (7), and its interior is provided with a cavity (13). The implant unit (2) is movably disposed in the cavity (13). A static sealing ring (15) is fixedly embedded in the annular groove at the entrance of the cavity (13). The lower end of the static sealing ring (15) is sealed to the bellows seal (16). The input unit (2) includes a column (21), a connecting plate (22), a static sealing ring II (23), a sealing piston (24), an electrode contact (25), a built-in power supply (26), a core processing chip (27), and a wireless communication module (28). The lower end of the column (21) is fitted with a sealing piston (24), and the sealing piston (24) is embedded with a static sealing ring II (23) for dynamic sealing with the inner wall of the cavity (13). The sealing piston (24) is dynamically sealed to the inner wall of the cavity (13). The upper end of the column (21) is fixed with a connecting plate (22), and the bottom of the column (21) is connected with an electrode contact (25). The lower end of the column (21) is conical.

2. The brain-computer interface implantable device for closed-loop regulation of epilepsy according to claim 1, characterized in that: The lower end of the biocompatible metal base (11) is provided with a groove (14), which communicates with the cavity (13). A clamping block (5) and a shaft (3) are provided in the groove (14). A roller (4) is provided on the shaft (3). A sliding hole is provided on the clamping block (5). The roller (4) passes through the sliding hole. A through hole is provided on the lower end face of the biocompatible metal base (11). The lower end of the electrode contact (25) passes through the through hole. The cone at the lower end of the column (21) can push the clamping block (5) out of the hole.

3. The brain-computer interface implantable device for closed-loop regulation of epilepsy according to claim 1, characterized in that: The ceramic sealing cover (12) forms an antenna window, and the antenna of the wireless communication module (28) is arranged below it.

4. The brain-computer interface implantable device for closed-loop regulation of epilepsy according to claim 1, characterized in that: The column (21) integrates a built-in power supply (26), a core processing chip (27), and a wireless communication module (28). The core processing chip (27) is electrically connected to the built-in power supply (26) and the wireless communication module (28), respectively. The core processing chip (27) includes a microprocessor with a pre-stored epilepsy feature signal recognition algorithm and a stimulation generation circuit for achieving closed-loop control. The upper surface of the connecting plate (22) is provided with a docking structure for cooperating with surgical tools.

5. The brain-computer interface implantable device for closed-loop regulation of epilepsy according to claim 1, characterized in that: The movable limiting mechanism (6) includes a movable column (61), a movable plate (62), a limiting rod (63), a screw (64), a bonding plate (65), and a guide rod (66). The bottom of the movable column (61) is fixed to the ceramic sealing cover (12). The movable column (61) is threadedly engaged with the inner side of the movable plate (62). The upper edge of the movable plate (62) is fixed with the limiting rod (63). The screw (64) is threadedly connected to the right end of the ceramic sealing cover (12). The bottom of the screw (64) is connected to the bonding plate (65). The bonding plate (65) is fixed to the lower end of the guide rod (66). The guide rod (66) is slidably engaged with the left end of the ceramic sealing cover (12). The upper end of the limiting rod (63) is in contact with the connecting plate (22). The column body (21) passes through the middle of the movable column (61).

6. The brain-computer interface implantable device for closed-loop regulation of epilepsy according to claim 5, characterized in that: The inner wall of the movable column (61) is provided with a first thread, which is engaged with the second thread on the outer side of the column body (21).

7. The brain-computer interface implantable device for closed-loop regulation of epilepsy according to claim 5, characterized in that: The moving limiting mechanism (6) also includes a compression spring (67) and a limiting buckle (68). The left end of the compression spring (67) is fixed to the inside of the moving plate (62), and the right end of the compression spring (67) is fixed to the limiting buckle (68).

8. The brain-computer interface implantable device for closed-loop regulation of epilepsy according to claim 1, characterized in that: The bellows seal (16) is made of a biocompatible elastic material.

9. The brain-computer interface implantable device for closed-loop regulation of epilepsy according to claim 7, characterized in that: Two sets of compression springs (67) and limit buckles (68) are provided, which are arranged opposite to each other on the left and right sides of the moving plate (62). The cross-section of the limit buckle (68) is hook-shaped, and the limit buckle (68) slides with the inner side of the moving plate (62).

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