Multi-functional head crown

Abstract

The application discloses a multifunctional head crown which is used in cooperation with a cranial implant stimulator, the implant stimulator comprising a first coil and a first power supply, the multifunctional head crown comprising a second coil, a second power supply and a controller, the second coil, the second power supply and the controller are all sewn in a head crown fabric suitable for a patient to wear, when the patient wears the head crown, the second coil can be inductively coupled with the first coil in the implant stimulator to charge the first power supply of the implant stimulator and perform radio frequency data communication as required. The multifunctional head crown provided by the application acts as a charger, a radio frequency data transceiver, a system communication hub, a sensing signal processor and a closed-loop control decision maker of the implant stimulator. The first power supply in the implant stimulator is wirelessly charged through coil coupling, and short-distance high-speed radio frequency data communication is performed with the implant stimulator through coil coupling, feedback data of the implant stimulator is received, and a control command is sent.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a multifunctional headdress. Background Technology

[0002] Currently, brain pacemakers, the brain neurostimulation implants used in clinical practice, are large and can only be implanted in the chest. This requires neurosurgeons to spend nearly 4 hours creating a subcutaneous tunnel to pass electrode leads from the top of the brain to the chest to connect to the brain pacemaker. In clinical use, the two electrode lead extensions, which are about 40-50 cm long and extend from the top of the brain to the chest, are the weakest implanted components. Because the head and neck rotate countless times every day, breakage of the electrode lead extensions is a common adverse event in clinical practice. In addition, depending on the individual patient's physical condition, infection caused by the leads extending from the head to the chest is another common and safety-related adverse event.

[0003] Beijing Pinchi Co., Ltd.'s patent, patent number CN103768712B, describes a head-implanted deep brain stimulation (DBS) system. In this invention, the brain pacemaker's IPG (pulse generator) uses a small-capacity rechargeable battery, resulting in a compact size that can be directly implanted into the skull, simplifying the implantation surgery and reducing the risk of wire breakage or infection caused by lengthy electrode leads. However, because its IPG control circuit consists of discrete components and uses a built-in charging coil, its size is limited, and the built-in charging antenna affects charging efficiency, posing a challenge to limiting the temperature rise of the casing. Although the patent mentions the possibility of an external charging coil configuration, charging and data communication still use different antennas, further limiting the size and requiring a larger craniotomy area for implantation.

[0004] Boston Scientific's patent CN108290045A filed in China discloses a skull-mounted brain pacemaker. In principle, the device could be made smaller, but its IPG does not have a battery and requires uninterrupted power from external components, which severely limits its clinical application. Furthermore, it uses an external electrode connector, and the limited size of the electrode connector increases the complexity and risk of infection in the head implantation surgery.

[0005] Furthermore, transcranial IPG devices are susceptible to impact damage when the head strikes hard objects, and neither of the aforementioned IPG fixation devices provides this protection. Functionally, neither IPG includes feedback mechanisms for neural signals or other signals, thus lacking the possibility of closed-loop stimulation control. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a multifunctional crown that can quickly charge the implanted stimulator and communicate data with the implanted stimulator, thereby improving the treatment experience.

[0007] To address the aforementioned technical problems, this invention provides a multifunctional crown for use with a cranial implant stimulator. The implant stimulator includes a first coil and a first power source, while the multifunctional crown includes a second coil, a second power source, and a controller. The second coil, the second power source, and the controller are all sewn into a crown fabric suitable for patient wear. When the patient wears the crown, the second coil can inductively couple with the first coil inside the implant stimulator to charge the first power source of the implant stimulator and perform radio frequency data communication as needed.

[0008] Preferably, the second coil is a stranded cable made of multiple insulated wires twisted together or a flat coil wound in a spiral shape with a single wire. The outer periphery of the second coil is encapsulated by injection molding of flexible material and then sewn into an appropriate position within the fabric of the multifunctional crown. The multifunctional crown is a hat adapted to the size of the patient's head. When the multifunctional crown is worn, the second coil covers the first coil.

[0009] Preferably, the second coil is a flat coil spirally wound from a stranded cable made of multiple strands of insulated copper wire, and the flexible material is silicone.

[0010] Preferably, the second power source is a second rechargeable battery, and the controller and the second rechargeable battery, as well as the controller and the second coil, are respectively connected by flexible cables.

[0011] Preferably, the controller includes a second microprocessor, which comprises a signal processing module, a stimulation modulation processing module, and a charging control firmware function module, respectively used to process and analyze the signals fed back by the implant stimulator, adjust stimulation parameters according to the feedback signals, and manage the charging process of the multifunctional crown on the implant stimulator.

[0012] Preferably, the controller includes a second Bluetooth transceiver and a coil drive module; the coil drive module includes a coil drive circuit, an RF signal transceiver circuit, and a coil inductive charging control interface circuit, and the second Bluetooth transceiver provides a Bluetooth communication channel for the multifunctional crown.

[0013] Preferably, the controller includes a second power management module, which includes a charging circuit for the second rechargeable battery, a charging input interface, a battery protection circuit, and a voltage regulation circuit. The voltage regulation circuit is responsible for providing a controllable driving voltage for the coil driving circuit and adjustment voltage for other circuits. The charging input interface is responsible for charging the second rechargeable battery through an external charging power supply. The battery protection circuit provides protection for the second rechargeable battery.

[0014] Preferably, the coil drive module is provided with a safety support circuit to ensure the radio frequency charging of the implanted stimulator.

[0015] Preferably, the second coil is sewn inside the insulating cap fabric at the position of the first coil corresponding to the implant, the controller is a thin rigid-flexible circuit board encapsulated in epoxy resin, sewn inside the fabric on one side edge of the multifunctional crown, and the second rechargeable battery is sewn on the other side edge of the multifunctional crown.

[0016] Preferably, the controller is equipped with a radio frequency signal strength detection circuit to determine and alert whether the position of the multifunctional crown has shifted.

[0017] Preferably, the multifunctional crown communicates via Bluetooth and works with a doctor using a programmer to set and adjust the stimulation prescription for the implanted stimulator.

[0018] Compared with existing technologies, this invention has the following advantages: 1. The flexible first coil within the implant and the flexible second coil within the multifunctional headdress of this invention can achieve tight inductive coupling, effectively improving the charging efficiency of the implant stimulator battery and reducing the risk of temperature rise caused by the high radio frequency power consumption required for charging the coil inside the shell. 2. The flexible first coil of the implant stimulator provided by this invention also serves as a radio frequency data antenna, effectively simplifying the physical structure of the implant stimulator and reducing its size. 3. The centimeter-level short-range radio frequency data communication achieved by the charging coil provided by this invention effectively improves the security of data exchange and can be used in conjunction with the Bluetooth communication channel simultaneously equipped with the multifunctional headdress to provide the possibility of dual-channel authentication for implant charging and remote control. 4. Clinical trials have demonstrated that closed-loop stimulation modes of DBS (deep brain stimulation) and RNS (reactive neurostimulation) have a significant effect on improving treatment efficacy. This invention provides a novel real-time closed-loop stimulation mode, achieved through the cooperation of the implant and the multifunctional headdress. Compared to closed-loop control achieved independently by the implant stimulator, the method described in this invention is more flexible, not limited by implant power consumption, and allows for easier algorithm adjustment. 5. The implant stimulator and the measurement, control, and stimulation system for forming a multifunctional crown provided by this invention offer a natural and effective research platform for clinical research and brain-computer interface development. 8. The mounting bracket structure for the implant stimulator provided by this invention further simplifies device implantation surgery and provides protection against impact risks to the implant. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the overall structure of the brain nerve electrical stimulation system in an embodiment of the present invention;

[0020] Figure 2 This is a schematic diagram of the brain nerve electrical stimulation system framework in an embodiment of the present invention;

[0021] Figure 3a This is a schematic diagram of the overall structure of the implantable stimulator in the first embodiment of the present invention. Figure 3b This is an exploded view of the implant stimulator in the first embodiment of the present invention;

[0022] Figure 4a and Figure 4b This is a schematic diagram of the internal structure of the implant stimulator in the first embodiment of the present invention;

[0023] Figure 5 This is a circuit diagram of the implant stimulator in an embodiment of the present invention;

[0024] Figure 6 This is a circuit diagram of the stimulator pulse generator in an embodiment of the present invention;

[0025] Figure 7 (a) is an internal assembly diagram of the metal casing in the first embodiment of the present invention. Figure 7 (b) is an internal assembly diagram of the circuit board installed inside the metal casing in an embodiment of the present invention;

[0026] Figure 8 (a) is an internal assembly diagram of the metal casing in the second embodiment of the present invention. Figure 8 (b) is an internal assembly diagram of the circuit board housed in the metal casing in the second embodiment of the present invention;

[0027] Figure 9 (a)- Figure 9 (d) are respectively the top view, side view, front view and perspective view of the circuit motherboard in the second embodiment of the present invention;

[0028] Figure 10 (a) Figure 10 (b) Figure 10 (c) Figure 10 (d) are respectively the side view, top view, perspective view and front view of the implant mounting bracket chassis in the first embodiment of the present invention;

[0029] Figure 11 (a) Figure 11 (b) Figure 11 (c) Figure 11 (d) are respectively the side view, top view, perspective view and front view of the implant mounting bracket cover in the first embodiment of the present invention;

[0030] Figure 12 (a) is a schematic diagram of the bracket chassis installed on the skull in the first embodiment of the present invention. Figure 12 (b) Figure 12 (c) is a schematic diagram of the insertion of the implant stimulator between the skull and scalp and the placement of the implant body into the chassis in the first embodiment of the present invention. Figure 12 (d) is a schematic diagram of the cover plate being placed on the chassis in the first embodiment of the present invention;

[0031] Figure 13 (a) is a schematic diagram of the state of the implant stimulator before it is placed into the skull head and skin suture in the first embodiment of the present invention. Figure 13 (b) is Figure 13 (a) is a cross-sectional view along the AA direction after the implanted stimulator has been installed. Figure 13 (c) is Figure 13 (a) A cross-sectional view along the BB direction after the implanted stimulator is installed.

[0032] Figure 14 (a) is a schematic diagram of the overall structure of the implantable stimulator in the third embodiment of the present invention. Figure 14(b) is an exploded view of the implant stimulator in the third embodiment of the present invention;

[0033] Figure 15 (a) is a schematic diagram of the overall structure of the implantable stimulator in the fourth embodiment of the present invention. Figure 15 (b) is an exploded view of the implant stimulator in the fourth embodiment of the present invention. Figure 15 (c) is a schematic diagram of the metal casing in the fourth embodiment of the present invention;

[0034] Figure 16 (a) is a schematic cross-sectional view of the implant stimulator after installation in the fourth embodiment of the present invention. Figure 16 (b) is a longitudinal cross-sectional view of the implanted stimulator after installation.

[0035] Figure 17 This is a schematic diagram of the structure of the multifunctional crown in an embodiment of the present invention;

[0036] Figure 18 This is a circuit diagram of the multifunctional crown in an embodiment of the present invention;

[0037] Figure 19 This is a schematic diagram of the autonomous mode of the brain nerve electrical stimulation system in an embodiment of the present invention;

[0038] Figure 20 This is a schematic diagram of the closed-loop mode of the brain nerve electrical stimulation system in an embodiment of the present invention.

[0039] In the picture:

[0040] 1-Implant stimulator, 11-Implant body, 111-Metal shell, 1111-First shell, 1112-Second shell, 1113-Third through hole, 1114-Protrusion, 1115-Fixing block, 112-Circuit main board, 1121-Mounting plate, 1122-First through hole, 1123-First side, 1124-Second side, 1125-Third side, 1126-Second through hole, 113-Rubber 114-First rechargeable battery, 1141-Positive / Negative electrode, 115-Frame, 1151-First space, 1152-Second space, 1153-Fixing post, 1154-Protrusion, 1155-Slot, 116-Shielding solder strip, 117-Pressure-sensitive film, 118-Electrode connector, 1181-Connecting socket, 1181a-Locking element, 1182-Electrode contact, 1183-Screw 1184-Seal, 1185-Electrode Protective Cover, 1186-Connector Housing, 1187-Fourth Through Hole, 1188-Fifth Through Hole, 1189-Fourth Screw Hole, 12-First Coil, 121-Protective Cover, 122-Bluetooth Chip Antenna, 123-Ceramic Circuit Board, 13-Stimulation Electrode, 131-Electrode Skull Cover, 15, 151, 152-Feedthrough Connector, 2-Multifunctional Crown, 21-Second Coil, 22-Controller, 23-Second Rechargeable Battery, 24-Flexible Cable, 3-Remote Control, 4-Programmer, 5-Skull, 6-Mounting Bracket, 61-Chassis, 62-First Hook, 621-First Screw Hole, 63-Screw, 64-Cover Plate, 65-Second Hook, 651-Second Screw Hole, 7-First Fixing Plate, 71-Third Screw Hole, 8-Scalp, 9-Dura mater, 10-Second Fixing Plate. Detailed Implementation

[0041] The present invention will now be further described with reference to the accompanying drawings and embodiments.

[0042] Figure 1 This is a schematic diagram of the overall structure of the brain nerve electrical stimulation system in an embodiment of the present invention; Figure 2 This is a schematic diagram of the functional framework of the brain nerve electrical stimulation system in an embodiment of the present invention.

[0043] Please see Figure 1 , Figure 2 and Figure 3bThis invention provides a brain nerve electrical stimulation system with sensing function, including an implantable stimulator 1 that can be implanted through the skull, a multifunctional headdress 2 that can be worn directly, a patient remote control 3, and a stimulation programmable device for doctors 4. The multifunctional headdress 2 is preferably a hat adapted to the size of the patient's head and can be worn on the patient's head. The implantable stimulator 1 includes an implant body 11, a stimulation electrode 13, and a first coil 12. The implant body 11 includes an electronic cavity sealed by a metal shell 111 and an electrode connector 118 encapsulated by a non-metallic material. The first coil 12 is disposed outside the metal shell 111. A first power supply and a circuit board 112 are disposed inside the electronic cavity. The circuit board 112 is connected to the electrode connector 118, and the electrode connector 118 is connected to the stimulation electrode 13. A current pulse generator is disposed on the circuit board 112. The current pulse output channel of the current pulse generator is connected to the stimulation electrode 13 through the electrode connector 118 to realize the electrical pulse stimulation function. The metal shell 111 is used as the loop electrode of the current pulse. The multifunctional headdress 2 includes a second coil 21, a second power supply, and a controller 22. In this embodiment, the second power supply is a second rechargeable battery 23. The second coil 21, the second rechargeable battery 23, and the controller 22 are all sewn into a headdress fabric suitable for the patient. Positioned by the headdress brim, when the patient wears the headdress, the second coil 21 and the first coil 12 achieve tight inductive coupling, charging the first power supply and enabling radio frequency data communication. In this embodiment, the first power supply is a first rechargeable battery 114, preferably a rechargeable lithium battery. The stimulation programmer 4, together with the multifunctional headdress 2, sets the stimulation prescription for the implantable stimulator 1 via Bluetooth communication, detects and analyzes the working status of the implantable stimulator 1, and exchanges data with the cloud server. The stimulation prescription includes parameters such as stimulation electrode contacts, stimulation mode, pulse frequency, and minimum / maximum current amplitude. The patient remote control 3 allows the patient to perform basic operational controls on the implantable stimulator 1, including turning stimulation on or off, adjusting the stimulation intensity, and starting or stopping the charging process.

[0044] The brain nerve electrical stimulation system provided in this embodiment of the invention includes a transcranial implantable stimulator 1 and a multifunctional headdress 2 suitable for long-term wear. These, together with a doctor-controlled stimulation program 4 and a patient-controlled remote 3, constitute a novel brain nerve electrical stimulation system. The functional operation of the brain nerve electrical stimulation system is as follows: Figure 2 As shown: In the first embodiment, please refer to Figure 3b , Figure 4a and Figure 4bThe circuit board 112 of the implantable stimulator 1 is equipped with 2n independent current pulse generators, where n is a positive integer not less than 4 and 2n is eight or more integers, forming eight or more independently controllable current pulse stimulation channels. The electrode connector 118 contains at least eight annular electrode contacts 1182, each consisting of a metal ring and a metal spring coil located within the metal ring. An insulating ring is placed between each pair of adjacent metal rings. Each current pulse stimulation channel within the sealed electronic cavity is connected to the corresponding contact in the electrode connector 118 via the pins of the feedthrough connector 15. The electrode connector 118 forms two n-channel connection sockets and connects to all electrode wires of the two stimulation electrodes 13, each containing at least four stimulation contacts. The two stimulation electrodes with at least four contacts support dual-cavity deep brain stimulation, and each electrode stimulation contact simultaneously supports neural signal detection applications. In other embodiments, more current pulse channels can be provided, and a correspondingly larger number of electrode contacts 1182 can be provided in the electrode connector 118, such as 16 electrode contacts 1182, with 8 electrode contacts on each side of the electrode connector 118 forming two eight-channel connection sockets, and so on, or even more such as 32 electrode contacts 1182, as long as the size of the electrode connector 118 is appropriate. The implant stimulator 1 uses a small rechargeable battery that can independently support continuous stimulation with a nominal current intensity for more than 3 days, and can be quickly charged through the first coil 12 and the multifunctional head crown 2. The implant stimulator 1 can also utilize the built-in nerve signal detection module and inertial measurement processor to achieve real-time closed-loop stimulation function together with the multifunctional head crown 2 through radio frequency data connection. At the same time, clinicians can use the stimulation programmer 4 to adjust the stimulation prescription of the implant stimulator 1 through Bluetooth communication and together with the multifunctional head crown 2, while patients can use the remote control 3 to select the stimulation prescription and adjust the stimulation intensity through Bluetooth communication.

[0045] Figure 3a This is a schematic diagram of the overall structure of the implantable stimulator in the first embodiment of the present invention. Figure 3b This is an exploded view of the implant stimulator in the first embodiment of the present invention. Figure 4a and Figure 4b This is a schematic diagram of the internal structure of the implant stimulator in the first embodiment of the present invention.

[0046] Please see Figures 3a-4bIn the first embodiment, the implant stimulator 1 consists of an implant body 11, two stimulation electrodes 13 and a first coil 12. The implant body 11 includes an electronic component cavity sealed by a titanium metal shell 111 and an electrode connector 118 encapsulated by PU (polyurethane) injection molding or epoxy resin. The sealed electronic cavity contains a medical first rechargeable battery 114 and a circuit board 112. The titanium metal shell 111 is used as a stimulation circuit electrode in the unipolar stimulation mode. Furthermore, the first coil 12 is disposed outside the metal shell 111. The conductor of the first coil 12 is a cable made of multiple strands of pure gold wire twisted together. The first coil 12 is a flexible flat coil with a protective sleeve 121, which is horizontally wound in a spiral manner using the cable and injection molded from a biocompatible flexible material with a thickness of less than 3 mm. It is then encapsulated with the metal shell 111 as a whole using a flexible material, preferably silicone or polyurethane (PU). The output end of the first coil 12 is connected to the charging module and data communication module on the circuit board 112 inside the sealed electronic cavity through the pins of the feedthrough connector 15. When implanted in the human body, the first coil 12 can be placed directly between the cerebral cortex and the skull without the need for craniotomy, i.e., without the need for a cranial incision, thereby reducing the craniotomy area and the cranial surgical wound, and also serving to fix the implant body 11. Furthermore, a Bluetooth communication component is also provided inside the protective sleeve 121 outside the first coil 12. The Bluetooth communication component includes a Bluetooth chip antenna 122 and a ceramic circuit board 123 carrying the Bluetooth chip antenna 122. The Bluetooth communication component is encapsulated with epoxy resin or other insulating materials and then encapsulated together with the first coil 12 with flexible materials such as silicone or polyurethane. It is connected to the first Bluetooth transceiver of the circuit board 112 through the pins of the feedthrough connector 15.

[0047] Furthermore, in the first embodiment, the first coil 12 and the electrode connector 118 are disposed on the same side of the metal housing 111, and the electrode connector 118 and the protective sleeve 121 of the first coil 12 are integrally formed and fixed to the side wall of the metal housing 111.

[0048] The first coil 12 is disposed outside the metal casing 111 and is a thin coil encapsulated in a biocompatible flexible material such as silicone or polyurethane. This achieves the following effects: 1) Compared to structures where the charging coil is placed inside the metal casing, it reduces the volume of the implantable stimulator, thus reducing the required craniotomy area; 2) It facilitates installation, allowing direct placement between the skull and scalp without occupying craniotomy space, thereby reducing the surgical incision; 3) When implanted into the human body, it can serve to fix the implant body; 4) It improves charging efficiency and reduces the risk of casing overheating during charging; 5) The first coil also functions as an inductively coupled data transmission antenna, enabling centimeter-level short-range data transmission and improving data communication security; 6) It reduces communication signal attenuation, solving the problems that high-frequency signals cannot be transmitted inside the metal casing, and that low-frequency transmission would increase antenna size, which is detrimental to implantable products.

[0049] Figure 5 This is a circuit diagram of the implant stimulator in an embodiment of the present invention; Figure 6 This is a circuit diagram of the stimulator pulse generator in an embodiment of the present invention.

[0050] Please see Figure 5 The circuit board 112 is equipped with an ASIC chip, a first microprocessor (MCU), a first Bluetooth transceiver (BLE), and an inertial measurement processor (IMU). The current pulse generator is located within the ASIC chip. The ASIC chip also includes a neural signal detection module, a wireless charging management module, a bidirectional radio frequency data communication module, and a first power management module. The first Bluetooth transceiver, the inertial measurement processor, the current pulse generator, the neural signal detection module, and the bidirectional radio frequency data communication module are all connected to the first microprocessor interface. The first microprocessor controls the input electrode selection, signal gain, and frequency response range of the neural signal detection module, the charging current and charging process output by the wireless charging management module, and the power supply voltage, stimulation current, pulse width, and pulse frequency of the current pulse generator.

[0051] Please see Figure 6 The first microprocessor sends a stimulation unit data packet containing the stimulation mode and stimulation amplitude to the stimulation unit control circuit of the current pulse generator in the form of instructions. The stimulation unit control circuit transmits the stimulation amplitude value to the digital-to-analog converter of the current pulse generator to convert it into a current value, and then converts it into the amplitude of the output pulse of the current pulse generator through the electrode driving circuit. The stimulation unit control circuit simultaneously transmits the stimulation mode information of the stimulation unit data packet to the switching logic. The switching logic controls the cathode and anode current output switches of the electrode driver and the switching of the loop electrode through a level shifter, thereby controlling the pulse width, pulse frequency, output polarity and output mode of the current stimulation pulse through the input control signal.

[0052] The neural signal detection module can use any combination of two or more stimulation electrode contacts as measuring electrodes to detect nerve region potentials or electrocorticography (ECG), and feeds the measured signals back to the multifunctional head crown 2 via the bidirectional radio frequency data communication module and the first coil 12. The inertial measurement processor monitors the patient's movement, such as walking and sleeping. Additionally, the inertial measurement processor can also detect changes in the patient's heart rate, providing a possible tool for detecting heart rate variations. The neural signal detection module uses any combination of two or more stimulation electrode contacts as measuring electrodes to detect nerve region potentials. The measured signals are stored in the implant's internal memory as needed or fed back to the multifunctional head crown 2 for processing via the bidirectional radio frequency data communication module and the first coil 12. The first Bluetooth transceiver is used to receive commands from the patient's remote control 3, such as selecting a stimulation prescription, setting the stimulation intensity, and turning stimulation on / off.

[0053] This invention utilizes a highly integrated, multifunctional application-specific integrated circuit (ASIC) chip to achieve an ultra-miniature implantable stimulator design with a volume approaching 4 ml. The implantable stimulator 1 comprises eight or more independent current pulse stimulation channels, connected via two electrode connectors 118 with at least four channels each to two stimulation electrodes 13, each containing at least four stimulation contacts, a first rechargeable battery 114, and a fast-charging first coil 12. The craniotomy area required for implantation is limited to approximately 25 mm x 25 mm, allowing the implantable stimulator 1 to be implanted at the optimal site in the human skull according to treatment needs, providing electrical stimulation to various brain nerve sites, such as the subthalamic nucleus, medial globus tumescentis, and hippocampus, to treat diseases such as Parkinson's disease, epilepsy, and depression.

[0054] Figure 7 (a) is an internal assembly diagram of the metal casing in the first embodiment of the present invention. Figure 7 (b) is an internal assembly diagram of the circuit board installed in the metal casing in the first embodiment of the present invention.

[0055] Please see Figure 3b , Figure 7 (a) and Figure 7(b) The metal housing 111 includes a first housing 1111 and a second housing 1112 that are matched and connected. In the first embodiment, a pressure-sensitive film 117, a frame 115, a first rechargeable battery 114, a rubber pad 113, and a circuit board 112 are sequentially arranged between the first housing 1111 and the second housing 1112. The frame 115 and the circuit board 112 are matched and connected. Further, a PCB mounting plate 1121 is vertically connected to the side of the circuit board 112 for connecting the pins of the feedthrough connector 15 inside the housing. The frame 115 is divided into a first space 1151 and a second space 1152. The first rechargeable battery 114 is placed in the first space 1151. The first rechargeable battery 114 can be configured to be cuboid. The end of the second space 1152 is an open end, and the feedthrough connector 15 is matched and installed. The second space 1152 has protrusions 1154 along the side walls on both sides. A slot 1155 is provided on the PCB 1121, and both ends of the PCB mounting plate 1121 are inserted into the slot 1155 for fixation. The pins of the feedthrough connector 15, placed on the end side of the second space 1152, are connected to the mounting plate 1121. A protective solder strip 116 is provided around the periphery of the frame 115, and the protective solder strip 116 surrounds the periphery of the frame 115 and abuts against the feedthrough connector 15 on the end side of the second space 1152 for fixation. Correspondingly, an opening for placing the feedthrough connector 15 is also provided on the second housing 1112. In this embodiment, the ASIC chip, the first microprocessor, the first Bluetooth transceiver, and the inertial measurement processor are all arranged on the same side of the circuit board 112, and the first rechargeable battery 114 is placed on the other side of the circuit board 112. The space height is minimized to meet the requirement of not exceeding the thickness of the skull by too much. The compact design makes the craniotomy size approximately 25*25 mm, achieving a small incision for brain pacemaker implantation surgery. The thickness of the metal housing 111 can be controlled to be around 6 mm. Multiple fixing posts 1153 with screw holes are provided on the side of the first space 1151 of the frame 115. The circuit board 112 is provided with corresponding first through holes 1122. After the screws are passed through the first through holes 1122 and fixed to the screw holes on the fixing posts 1153, the circuit board 112 is fixed to the frame 115, and the first rechargeable battery 112 is confined in the first space 1151.

[0056] Figure 8 (a) is an internal assembly diagram of the metal casing in the second embodiment of the present invention. Figure 8 (b) is an internal assembly diagram of the circuit board housed in the metal casing in the second embodiment of the present invention; Figure 9 (a)- Figure 9 (d) are the top view, side view, front view and perspective view of the circuit board in the second embodiment of the present invention, respectively.

[0057] Please see Figure 8 (a)- Figure 9(d) In the second embodiment, the circuit board 112 is a rigid-flexible circuit board, which is bent and surrounds the first rechargeable battery 114. Specifically, it includes a first side 1123, a second side 1124, and a third side 1125. The first side 1123 is connected to the pins of the feedthrough connector 15. Various components are arranged on the third side 1125. A second through hole 1126 is provided on the second side 1124. The positive / negative electrode 1141 protruding from the end of the first rechargeable battery 114 is inserted into the second through hole 1126. This structure makes the implantable stimulator 1 smaller in size. This structure can ensure that the total thickness of the implantable stimulator 1 meets the requirements for transcranial implantation even when the battery thickness is close to 5 mm. Other structures are similar to those in the first embodiment.

[0058] Figure 10 (a) Figure 10 (b) Figure 10 (c) Figure 10 (d) are respectively the side view, top view, perspective view and front view of the implant mounting bracket chassis in the first embodiment of the present invention; Figure 11 (a) Figure 11 (b) Figure 11 (c) Figure 11 (d) are the side view, top view, perspective view and front view of the implant mounting bracket cover in the first embodiment of the present invention.

[0059] Please see Figure 10 (a)- Figure 11 (d) In the first embodiment, the implantable stimulator 1 further includes a mounting bracket 6, which includes a base 61, a cover plate 64, and screws 63. The edges of the base 61 and the cover plate 64 are provided with hooks, and the hooks are provided with screw holes. Specifically, the edge of the base 61 forms a plurality of first hooks 62. Preferably, there are three first hooks 62, which are located on the two long sides of the base 61. Each first hook 62 is provided with a first screw hole 621. The cover plate 64 is fitted onto the base 61. The edge of the cover plate 64 forms a plurality of second hooks 65. Preferably, there are three second hooks 65, which are located on the two long sides of the cover plate 64. Each second hook 65 is provided with a second screw hole 651. After installation, the second hook 65 and the first hook 62 are staggered. One side of the mounting bracket 6 includes two first hooks 62 and a second hook 65 located between the two first hooks 62. The other side of the mounting bracket 6 includes two second hooks 65 and a first hook 62 located between the two second hooks 65. Screws 63 are used to fix the chassis 61 and the cover plate 64 to the edge of the opening in the skull 5.

[0060] Figure 12 (a) is a schematic diagram of the bracket chassis installed on the skull in the first embodiment of the present invention. Figure 12 (b) Figure 12 (c) is a schematic diagram of the insertion of the implant stimulator between the skull and scalp and the placement of the implant body into the chassis in the first embodiment of the present invention. Figure 12 (d) is a schematic diagram of the cover plate being placed on the chassis in the first embodiment of the present invention.

[0061] When implanting the implantable stimulator 1 into the skull, the process of installing the implantable stimulator 1 within the skull 5 via the mounting bracket 6 is as follows:

[0062] Please see Figure 12 (a) First, the base plate 61 is mounted on the skull 5 using screws 63 through the first screw hole 621. Next, please refer to... Figure 12 (b) and Figure 12 (c) The implant body 11 is placed on the chassis 61, and the first coil 12 is placed between the scalp 8 and the skull 5, as shown. Figure 13 As shown in (c), the thin, flexible first coil 12, disposed outside the implant body 11, can be directly placed between the skull 5 and the scalp 8, which facilitates installation, saves the skull opening area, and also serves to fix the implant body 11 installed on the skull; then, please refer to Figure 12 (d) Cover the implant body 11 with the cover plate 64, which covers the top of the implant body 11, enclosing the implant body 11 within the cavity formed by the chassis 61 and the cover plate 64. Secure the cover plate 64 to the skull 5 using screws 63 through the second screw hole 651. After the mounting bracket 6 is installed, as shown... Figure 13 (a) and Figure 13 As shown in (b), the surface of the implant body 11 after the cover plate 64 is installed is approximately flush with the surface of the first coil 12.

[0063] The mounting bracket 6, which includes a chassis 61 and a cover plate 64, is used as a fixation device for the implant stimulator 1, which facilitates surgery and prevents possible damage to the implant stimulator 1 when the head hits a hard object.

[0064] Due to the ultra-thin structure of the implant stimulator 1, the total transcranial installation thickness of the implant body 11, including the mounting bracket 6, does not exceed 4 mm. The human skull is generally 6-10 mm thick, and the skull of Chinese people is relatively thin, at 6-8 mm. Therefore, the implant stimulator 1 provided by this invention can be safely fixed to the skull 5 and placed on the dura mater 9, achieving the following advantages: (1) It facilitates surgery, reduces surgical trauma, eliminates the burden and risk of electrode extension lines, overcomes adverse events such as infection and electrode lead breakage that are prone to occur in clinical treatment, and improves the treatment effect. (2) Another advantage of cranial implantation of a brain pacemaker is that it reduces the surgical steps and time required for clinicians to perform tunneling and lead threading during implantation, and also reduces the surgical risk, because there are complex structures such as arteries, veins, and vagus nerves near the patient's head and neck, and the risk of electrode lead threading through tunnels is very high. (3) Another advantage is that it greatly simplifies the replacement and removal of the implant stimulator 1, because the doctor only needs to remove the implant stimulator 1 from the head, without having to remove the electrode extension wire, and at the same time, it reduces the risk of removing the electrode wire, because the long-term implanted wire is prone to form connective tissue with the surrounding tissue in the patient's neck, and the doctor may need to separate it before removing the stimulation electrode, which has a high surgical risk and causes great trauma to the patient.

[0065] Figure 14 (a) is a schematic diagram of the overall structure of the implantable stimulator in the third embodiment of the present invention. Figure 14 (b) is an exploded view of the implant stimulator in the third embodiment of the present invention.

[0066] Please see Figure 14 (a) and Figure 14 (b) In the third embodiment, the first housing 1111 is provided with a plurality of first fixing plates 7. Unlike the first and second embodiments, in this embodiment, the bracket 6 is not required, thus simplifying the structure. Specifically, a first fixing plate 7 is provided on each of the three sides of the first housing 1111. Each first fixing plate 7 is provided with a third screw hole 71. The implant stimulator 1 is fixed to the skull 5 by screws 63 passing through the third screw holes 71. The first fixing plates 7 can be fixed to the first housing 1111 by welding.

[0067] Figure 15 (a) is a schematic diagram of the overall structure of the implantable stimulator in the fourth embodiment of the present invention. Figure 15 (b) is an exploded view of the implant stimulator in the fourth embodiment of the present invention; Figure 16 (a) is a cross-sectional view of the implant stimulator after installation in the fourth embodiment of the present invention. Figure 16 (b) is a longitudinal cross-sectional view of the implanted stimulator after installation.

[0068] Please see Figure 15 (a) and Figure 15(b) In the fourth embodiment, to separate the antenna signal and the stimulation signal and avoid mutual interference, the first coil 12 and the electrode connector 118 are respectively disposed on both sides of the metal housing 111. The electrode connector 118 is encapsulated with epoxy resin or polyurethane (PU) and connected to the current pulse output channel of the current pulse generator through the pins of the feedthrough connector 151 to output the stimulation signal. The feedthrough connector 151 has 8 pins. The first coil 12 is encapsulated with flexible materials such as silicone or polyurethane (PU) and connected to the charging module, data communication module and first Bluetooth transceiver on the circuit board 112 through the pins of the feedthrough connector 152. Further, as in the first embodiment, a Bluetooth communication component is provided inside the protective sleeve 121. The Bluetooth communication component includes a Bluetooth crystal. The chip antenna 122 and the ceramic circuit board 123 carrying the Bluetooth chip antenna 122 are included. In other embodiments, the Bluetooth communication component can also be a wire antenna wound in a predetermined shape or length. The Bluetooth communication component is encapsulated with epoxy resin or other insulating materials and then encapsulated together with the first coil 12 with flexible materials such as silicone or polyurethane (PU). The output end of the first coil 12 is connected to the charging module and data communication module on the circuit board 112 through the pins of the feedthrough connector 152. The output end of the Bluetooth communication component is connected to the first Bluetooth transceiver on the circuit board 112 through the pins of the feedthrough connector 152. The feedthrough connector 152 has four pins, two of which are connected to the output end of the first coil 12 and the other two are connected to the output end of the Bluetooth communication component.

[0069] The electrode connector 118 includes a connection socket 1181 and a connector housing 1186 disposed outside the connection socket 1181. The connector housing 1186 is preferably formed by epoxy resin encapsulation. The connection socket 1181 includes a locking member 1181a and annular electrode contacts 1182. A fourth through hole 1187 is provided on the front wall of the connector housing 1186, allowing the stimulation electrode 13 to be inserted into the connection socket 1181. The locking member 1181a and the electrode contacts 1182 are placed inside the connector housing 1186. The annular electrode contacts 1182 are composed of multiple metal rings and metal spring coils located within the metal rings. An insulating ring is provided between two adjacent metal rings. A fifth through hole 1188 is provided on the upper and lower surfaces of the connector housing 1186. The locking member 1181a... The locking member 1181a has a fourth screw hole 1189, and the fourth screw hole 1189 and the fifth through hole 1188 are positioned correspondingly. After the screw 1183 is screwed into the fifth through hole 1188 and the fourth screw hole 1189, the stimulation electrode 13 is fastened in the connection socket 1181. The sealing member 1184 is inserted into the fifth through hole 1188 for sealing. Furthermore, the metal ring and the insulating ring are bonded and fixed together. The end of the locking member 1181a is provided with an electrode protective sleeve 1185, which can protect the stimulation electrode 13. The materials of the sealing member 1184 and the electrode protective sleeve 1185 are preferably silicone. The electrode protective sleeve 1185 and the locking member 1181a can be initially pre-fixed with silicone, and then epoxy resin or polyurethane (PU) is used to encapsulate and fix them together. Furthermore, the electrode connector 118 can be directly bonded to the side wall of the metal housing 111, or a fixing block 1115 is provided on the side wall where the metal housing 111 connects to the electrode connector 118. When the electrode connector 118 is encapsulated with epoxy resin or polyurethane (PU), it is connected to the side wall of the metal housing 111 through the fixing block 1115.

[0070] The implant stimulator 1 provided in this embodiment has a more reasonable arrangement of electronic components and circuit wiring, which makes the output signal of the implant stimulator 1 more effective. At the same time, it increases the manufacturability of the structure. When assembling this product, due to its ultra-small size, the difficulty of various processes increases. The manufacturability and testability of the product are taken into consideration during the design, which is a prerequisite for ensuring the reliability of the product.

[0071] Please continue reading Figure 15(b) In the fourth embodiment, the metal housing 111 includes a first housing 1111 and a second housing 1112 that are matched and connected. The second housing 1112 is a base plate with a protrusion 1114 on it. The first rechargeable battery 114 is placed within the area enclosed by the protrusion 1114. The contact points between the second housing 1112, the first rechargeable battery 114 and the circuit board 112 are provided with insulating material for electrical isolation, such as: an electrical insulating material is inlaid between the protrusion 1114 and the first rechargeable battery 114. The circuit board 112 is mounted on the first rechargeable battery 114. The first housing 1111 is a box that is fastened to the second housing 1112. The side wall of the first housing 1111 that connects to the first coil 12 and the electrode connector 118 is provided with a third through hole 1113 that matches the feedthrough connectors 151 and 152. The feedthrough connectors 151 and 152 on both sides are installed in the corresponding third through holes 1113. The other two side walls of the first housing 1111 are provided with second fixing plates 10, which are fixedly mounted on the skull 5.

[0072] Please see Figure 16 (a) and Figure 16 (b) The implant stimulator 1 disclosed in this embodiment is an implantation method in which the implant body 11 is implanted into the skull 5 without penetrating the skull. This structure requires increased strength of the metal shell 111 of the implant body 11 to withstand the consequences of the implant body 11 protruding from the scalp. Therefore, the thickness of the metal shell 111 is increased. Generally, the shell thickness of the implant stimulator 1 is between 0.2-0.3 mm. In this embodiment, the thickness of the lower shell 1112 of the metal shell 111 is 0.4-0.6 mm, and the thickness of the surrounding shell is increased to 0.75 mm. The thickness of the first shell 1111 is increased to 0.5 mm to ensure the strength requirements of impact resistance. Therefore, when the implant stimulator 1 provided in this embodiment is implanted into the human body, the implant body 11 is directly implanted into the skull without penetrating the skull. Furthermore, the first coil 12 and the electrode connector 118 are respectively located on both sides of the metal shell 111, which is more conducive to the effectiveness and accuracy of electronic signal transmission.

[0073] Therefore, 1. The cranial implant stimulator provided by this invention allows the implant to be fixed in the skull, greatly reducing the complexity of the implantation surgery, eliminating the infection and malfunction risks associated with electrode lead extension lines, overcoming current clinical pain points, saving neurosurgeons the extra several hours of surgical time required to tunnel and pull the electrode leads to the chest for connection with the brain pacemaker, as well as the risks of infection and electrode lead breakage during clinical treatment. 2. The implant stimulator provided by this invention has a compact and reasonable internal structure, with a total thickness controllable to within 6.5mm. It requires only a cranial incision of approximately 25mm*25mm, without the need for a complete skull opening or even penetrating the skull, eliminating the risk of touching the dura mater, and minimizing surgical trauma. 3. The flexible first coil of the implant stimulator provided by this invention also serves as a radio frequency data antenna, effectively simplifying the physical structure of the implant stimulator and reducing its size. 4. The centimeter-level short-range radio frequency data communication provided by the present invention, achieved through a charging coil, effectively improves the security of data exchange and can be used in conjunction with the Bluetooth communication channel simultaneously equipped in the implant to provide the possibility of dual-channel authentication for implant charging and remote control. 5. Clinical trials have demonstrated that closed-loop stimulation modes of DBS (Deep Brain Stimulation) and RNS (Reactive Neurostimulation) have a significant effect on improving treatment efficacy.

[0074] Figure 17 This is a schematic diagram of the structure of the multifunctional crown in an embodiment of the present invention; Figure 18 This is a circuit diagram of the multifunctional crown in an embodiment of the present invention.

[0075] This invention utilizes the features of the implanted stimulator 1 head mounting and the first coil 12 to equip the system with an important multifunctional head crown 2. Its objectives are: 1) to achieve high-efficiency charging and highly reliable short-range bidirectional data communication; 2) the multifunctional head crown is designed to fit snugly and comfortably against the patient's head, eliminating the need for additional auxiliary fixation devices such as bandages when working with the implanted stimulator 1, thus not affecting the patient's freedom of movement; 3) utilizing the nerve and motion signal detection functions of the implanted stimulator 1, through short-range bidirectional data communication, to provide a clinical data acquisition platform for real-time stimulation and free movement of the patient; 4) utilizing the nerve and motion signal detection functions of the implanted stimulator 1, through short-range bidirectional data communication, to help achieve the recording, processing, and analysis of feedback signals, realizing closed-loop control of brain stimulation without affecting the power consumption of the implanted battery.

[0076] Please see Figure 17The multifunctional headdress 2 is equipped with a second coil 21, a controller 22, and a second rechargeable battery 23. The controller 22 and the second rechargeable battery 23, and the controller 22 and the second coil 21, are connected by flexible cables 24. The multifunctional headdress 2 is a cap adapted to the size of a patient's head, and the cap can be designed in various styles; this invention does not impose any particular limitations on this. When the multifunctional headdress 2 is worn, the second coil 21 covers the first coil 12. The size of the second coil 21 and the design of the controller 22 should ensure that the headdress has appropriate room for movement. The second coil 21 is a stranded cable made of multiple strands of insulated copper wire or a flat coil wound in a spiral pattern with a single wire. The outer periphery of the second coil 21 is injection-molded and encapsulated with silicone or other flexible materials and sewn into the fabric of the multifunctional headdress 2 at an appropriate position. The controller 22 is a thin rigid-flexible circuit board encapsulated with epoxy resin or other insulating materials and sewn into the fabric along one edge of the multifunctional headdress 2. The second rechargeable battery 23 is sewn into the other edge of the headdress. The second rechargeable battery 23 is preferably a rechargeable lithium battery. The capacity of the second rechargeable battery 23 is sufficient to fully charge the built-in first rechargeable battery 114 of the implantable stimulator 1 more than twice, or to operate continuously for more than 12 hours in closed-loop stimulation mode. Charging of the second rechargeable battery 23 can be achieved via USB or a dedicated interface through the charging module circuitry. The total weight of the multifunctional headdress 2, including the second rechargeable battery 23, does not exceed 250 grams, so that the patient is not affected by a heavy load when wearing the headdress.

[0077] Please see Figure 18The controller 22 includes a second microprocessor, a second Bluetooth transceiver, a second power management module, and a coil drive module. The second microprocessor includes a signal processing module, a stimulation adjustment processing module, and a charging control firmware function module, which are used to process and analyze the signals fed back by the implant stimulator, adjust stimulation parameters according to the feedback signals, and manage the charging process of the multifunctional crown on the implant. The coil drive module includes a coil drive circuit, a radio frequency signal transceiver circuit, and a coil induction charging control interface circuit. The second power management module includes a second rechargeable battery charging circuit, a charging input interface, a battery protection circuit, and a voltage regulation circuit. The voltage regulation circuit is responsible for providing a controllable driving voltage for the coil drive circuit and adjustment voltage for other circuits. The charging input interface is responsible for charging the second rechargeable battery through an external charging power supply and providing protection. The second Bluetooth transceiver provides a Bluetooth communication channel for the multifunctional crown 2. The signal processing module is used to process the signals fed back by the implant stimulator and extract useful information. The stimulation adjustment processing module adjusts the stimulation parameters of the implant according to the feedback signals. Furthermore, the coil drive module is provided with a safety support circuit to ensure the radio frequency charging of the implant stimulator. To ensure that the device can be worn for extended periods without restricting the patient's freedom of movement, the coil drive module is designed to deliver high-efficiency power output while maintaining the surface temperature rise of the multifunctional crown 2 within a safe range. Furthermore, the controller includes a radio frequency signal strength detection circuit to determine and alert the user to any positional deviation of the multifunctional crown.

[0078] Therefore, the multifunctional headgear 2 achieves the following functions: 1) Acts as a charger for the implantable stimulator 1: wirelessly charges the first rechargeable battery 114 inside the implantable stimulator 1 via coil coupling; 2) A communication hub: conducts short-range high-speed radio frequency data communication with the implantable stimulator 1 via coil coupling, receives feedback data from the implantable stimulator 1, and sends control commands. Simultaneously, it communicates with the physician's programmable controller 4 and remote control via Bluetooth. The programmable controller 4 has a surgical mode, allowing data exchange with the implantable stimulator 1 directly or via the multifunctional headgear 2 or the patient's remote control during the patient's post-operative recovery phase; 3) A data processing and control center: records the feedback data from the implantable stimulator 1, processes and analyzes the feedback data in closed-loop mode, extracts information related to treatment, and determines real-time adjustments to stimulation parameters.

[0079] Figure 19 This is a schematic diagram of the autonomous mode of the brain nerve electrical stimulation system in an embodiment of the present invention; Figure 20 This is a schematic diagram of the closed-loop mode of the brain nerve electrical stimulation system in an embodiment of the present invention.

[0080] The brain nerve electrical stimulation therapy system provided in this embodiment has dual working modes, namely the implanted stimulator autonomous stimulation mode and the system closed-loop mode.

[0081] In voluntary stimulation mode, implantable stimulator 1 operates in the same open-loop manner as existing clinically used implantable stimulators. The operating procedure is as follows: Figure 19 As shown: The implantable stimulator 1 has stimulation parameters and stimulation modes set according to the stimulation prescription, including the combination of stimulation electrode contacts, stimulation polarity, beat, pulse amplitude range, frequency, width, modulation mode, etc. Multiple stimulation prescriptions can be available. The stimulation parameters are determined based on the stimulation effect within the stimulation safety threshold during the initial adjustment and testing phase after the stimulator implantation surgery. The patient can select a stimulation prescription and adjust the stimulation intensity via remote control 3 according to their specific sensations and the needs of the situation. The implantable stimulator 1 can automatically change the stimulation prescription or adjust the stimulation intensity based on the patient's posture and movement detected by the inertial sensor, but the patient can also change the stimulation prescription via remote control 3.

[0082] In this autonomous stimulation mode, a multifunctional headdress 2 is required for both IPG operating states: implant stimulator charging and neural potential recording. Furthermore, the system's operating modes can only be switched via the multifunctional headdress.

[0083] The closed-loop system mode requires the combined use of the implanted stimulator 1 and the multi-functional headdress 2. This system mode can be initiated by command from the programmer 4 after the headdress 2 is worn and the system is paired. The workflow diagram for this mode is as follows: Figure 20 As shown. In this mode, the stimulation prescription for the stimulator is still selected by the remote control 3, but the nerve signal detection function and the inertial measurement processor are activated. The implanted stimulator 1 transmits real-time nerve region potential signals and patient movement status signals to the head crown 2 through the radio frequency data channel. At the same time, the patient can also input some predetermined status commands through the remote control 3, such as medication status. The multifunctional head crown 2 starts the signal processing and stimulation decision function. Based on the received feedback information, it determines new stimulation parameters according to a predefined algorithm and sends them to the implanted stimulator 1 in a timely manner through the radio frequency data channel.

[0084] In closed-loop system mode, the crown can simultaneously charge or stop charging the implanted stimulator battery according to remote control commands.

[0085] In closed-loop system mode, if the radio frequency communication between the implant and the multifunctional crown is interrupted, the implant stimulator automatically enters the autonomous stimulation mode and continues to work.

[0086] Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications and improvements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be defined by the claims.

Claims

1. A multifunctional headdress, characterized in that, Used in conjunction with a cranial implant stimulator, the implant stimulator includes an implant body, a first coil, and a first power source. The multifunctional crown includes a second coil, a second power source, and a controller. The second coil, the second power source, and the controller are all sewn into a crown fabric suitable for the patient. The multifunctional crown is a cap adapted to the patient's head size. The outer periphery of the second coil is injection molded from a flexible material and then sewn into an appropriate position within the fabric of the multifunctional crown. When the multifunctional crown is worn, the second coil covers the first coil. The second coil can charge the first power source of the implant stimulator and perform radio frequency data communication as needed through inductive coupling with the first coil inside the implant stimulator. The controller and the second power source, and the controller and the second coil, are respectively connected by flexible cables. The controller includes a second microprocessor, which comprises a signal processing module, a stimulation modulation processing module, and a charging control firmware function module, which are respectively used to process and analyze the signals fed back by the implant stimulator, adjust stimulation parameters according to the feedback signals, and manage the charging process of the multifunctional crown on the implant stimulator. The implant body includes an electronic cavity sealed by a metal shell and an electrode connector encapsulated by a non-metallic material. The first coil is disposed outside the metal shell. The first power supply and a circuit board are disposed inside the electronic cavity. A current pulse generator is disposed on the circuit board. The current pulse output channel of the current pulse generator is connected to the stimulation electrode through the electrode connector to realize the electrical pulse stimulation function; the metal shell is used as the loop electrode of the current pulse; the first coil is a flat coil with a protective sleeve, which is horizontally wound in a spiral shape with a cable and injected into a biocompatible flexible material to form a thickness of less than 3 mm, and is encapsulated with the metal shell by the flexible material; the output end of the first coil is connected to the charging module and data communication module on the circuit board in the sealed electronic cavity through the pin of the feedthrough connector. When implanted in the human body, the first coil is placed directly between the cerebral cortex and the skull, without the need for skull cutting, and plays the role of fixing the implant body.

2. The multifunctional crown as described in claim 1, characterized in that, The second coil is a stranded cable made of multiple insulated wires twisted together or a flat coil wound in a spiral with a single wire.

3. The multifunctional crown as described in claim 2, characterized in that, The second coil is a flat coil spirally wound from a stranded cable made of multiple strands of insulated copper wire, and the flexible material is silicone.

4. The multifunctional crown as described in claim 1, characterized in that, The second power source is a second rechargeable battery.

5. The multifunctional crown as described in claim 1, characterized in that, The controller includes a second Bluetooth transceiver and a coil drive module; the coil drive module includes a coil drive circuit, an RF signal transceiver circuit, and a coil inductive charging control interface circuit, and the second Bluetooth transceiver provides a Bluetooth communication channel for the multi-functional crown.

6. The multifunctional crown as described in claim 5, characterized in that, The controller includes a second power management module, which includes a charging circuit for a second rechargeable battery, a charging input interface, a battery protection circuit, and a voltage regulation circuit. The voltage regulation circuit is responsible for providing a controllable driving voltage for the coil driving circuit and adjustment voltage for other circuits. The charging input interface is responsible for charging the second rechargeable battery through an external charging power supply. The battery protection circuit provides protection for the second rechargeable battery.

7. The multifunctional crown as described in claim 5, characterized in that, The coil drive module is equipped with a safety support circuit to ensure the safe charging of the implanted stimulator via radio frequency.

8. The multifunctional crown as described in claim 4, characterized in that, The second coil is sewn inside the insulating cap fabric corresponding to the position of the first coil of the implant. The controller is a thin rigid-flexible circuit board encapsulated in epoxy resin and sewn inside the fabric on one side edge of the multifunctional crown. The second rechargeable battery is sewn on the other side edge of the multifunctional crown.

9. The multifunctional crown as described in claim 1, characterized in that, The controller is equipped with a radio frequency signal strength detection circuit to determine and alert whether the position of the multifunctional crown has shifted.

10. The multifunctional crown as described in claim 1, characterized in that, The multifunctional crown communicates via Bluetooth and works with a doctor's programmable controller to set and adjust the stimulation prescription for the implanted stimulator.

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