WO2024032814A1 - Brain nerve electrical stimulation system with sensing function - Google Patents

Abstract

Disclosed in the present invention is a brain nerve electrical stimulation system with a sensing function. The brain nerve electrical stimulation system comprises an implant stimulator, a stimulation electrode, a multifunctional headgear, a remote controller, and a program controller. The implant stimulator comprises an implant main body and a first coil, with the first coil arranged outside the implant main body. The implant main body comprises an electronic cavity sealed by a metal shell and an electrode connector. A first power supply and a circuit mainboard are arranged in the electronic cavity, and a current pulse generator is arranged on the circuit mainboard. A current pulse output channel of the current pulse generator is connected to the stimulation electrode by means of the electrode connector. The multifunctional headgear comprises a second coil, and the second coil and the first coil engage in inductive coupling to charge the first power supply and transmit a data signal. The brain nerve electrical stimulation system removes an electrode wire extension line, thus reducing the volume of the implant stimulator and minimizing surgical trauma. Simultaneously, the system is equipped with a multifunctional headgear, eliminating the need for extra fixing measures, which allows for rapid charging as well as safe data communication, thereby improving the treatment experience of a patient.

Description

A brain nerve electrical stimulation system with sensory function Technical field

The invention relates to the field of medical devices, and in particular to a brain nerve electrical stimulation system with sensing function.

Background technique

The brain electrical stimulation implant currently used clinically, that is, the brain pacemaker, is large and can only be implanted in the chest, which requires neurosurgeons to spend nearly 4 hours to make a subcutaneous tunnel to connect the electrodes from the top of the brain. The wires are passed through the chest to connect to the brain pacemaker, and in clinical use in patients with implanted brain pacemakers, two electrode lead extension wires extending from the top of the brain to the chest are about 40-50 cm in length. Weak implant parts, because the human head and neck rotate countless times every day, and the breakage of the electrode lead extension is a common clinical adverse event. In addition, depending on the patient's individual constitution, the lead extending from the head to the chest may cause Infections are another common and safety-critical adverse event.

Beijing Pinchi Company's patent, patent number CN103768712B, describes a head-implanted deep brain stimulation system (DBS, deep brain stimulation). In this invention, the IPG (pulse generator) of the brain pacemaker uses a small-capacity The rechargeable battery is small and can be implanted directly into the skull, simplifying the implantation surgery and reducing the risk of lead breakage or infection caused by lengthy electrode leads. However, because its IPG control circuit is composed of discrete components and uses a built-in charging coil, the size is limited, and the built-in charging antenna affects the charging efficiency, posing challenges to the limitation of temperature rise of the chassis. Although the patent mentions the possible configuration of an external charging coil, different antennas are still used for charging and data communication, the size is still limited, and a larger craniotomy size is required for implantation.

The CN108290045A patent applied by Boston Technology Company in China discloses a skull-mounted brain pacemaker. In principle, the size can be made smaller. However, its IPG does not have a battery and requires uninterrupted power supply from external supporting devices. Clinical application is subject to hard restrictions. , and it uses an external electrode connector. Due to the limited size of the electrode connector, it adds complexity and infection risk to the cranial implant surgery.

In addition, transcranially installed IPG devices are easily damaged by impact when the head hits a hard object. Neither of the two IPG fixation devices invented above provides such protection. In terms of function, both IPGs do not include feedback methods for neural signals or other signals, so there is no possibility of closed-loop stimulation control.

technical problem

The technical problem to be solved by the present invention is to provide a brain nerve electrical stimulation system with sensing function, simplify the structure of the implanted stimulator, reduce the volume of the implanted stimulator, reduce surgical trauma, and at the same time be equipped with an external control device that is easy to wear. The device can be quickly charged and securely communicates data to improve the treatment experience.

Technical solutions

In order to solve the above technical problems, the present invention provides a brain nerve electrical stimulation system with sensing function, including an implant stimulator and stimulation electrode that can be implanted through the skull, a multifunctional head crown that can be directly worn, and a patient remote control The implant stimulator includes an implant body and a first coil. The implant body includes an electronic cavity sealed by a metal shell and an electrode connector sealed by a non-metallic material. , the first coil is arranged outside the metal shell, a first power supply and a circuit mainboard are arranged in the electronic cavity, a current pulse generator is arranged on the circuit mainboard; the current pulse output channel of the current pulse generator passes through The electrode connector is connected with the stimulation electrode to realize the electric pulse stimulation function; the metal shell is used as a loop electrode for the current pulse; the multifunctional head crown includes a second coil, a second power supply and a controller. The second coil, the second rechargeable battery and the controller are all sewn into a crown fabric suitable for the patient to wear. When the patient wears the crown, the second coil and the first coil are inductively coupled. Charge the first power source and perform radio frequency data communication as needed; the stimulation programmable controller communicates with the multifunctional head crown via Bluetooth, sets stimulation prescriptions for the implant stimulator, and detects and analyzes the implant The working status of the body stimulator, and data exchange with the cloud server; the stimulation prescription includes stimulation electrode contacts, stimulation mode, pulse width, pulse frequency, or/and, minimum/maximum amplitude; the patient remote control is used to allow The patient exercises control over the implanted stimulator, including starting or ending stimulation, adjusting stimulation intensity, inputting medication status, or/and starting or ending the charging process.

Preferably, 2n independent current pulse generators are provided on the main circuit board to form 2n independently controllable current pulse stimulation channels, and 2n ring-shaped electrode contacts are provided in the electrode connector. Each current pulse stimulation channel in the sealed electronic cavity is connected to the corresponding contact point of the electrode connector through the pin of the connector. The electrode connector constitutes two n-channel connection sockets, respectively with All electrode leads of the two stimulation electrodes are connected, and each stimulation electrode contains n stimulation contacts, where n is a positive integer not less than 4.

Preferably, the conductor of the first coil is a cable made of twisted pure gold wires, and the first coil is spirally wound horizontally with the cable and injection molded with a biocompatible flexible material to a thickness of A flat coil of less than 3 mm with a protective sheath is integrally packaged with the metal shell using the flexible material; the output end of the first coil is connected to the sealed electronics through the pin of the feedthrough connector. The charging module and the data communication module on the circuit motherboard in the cavity are connected. When implanted into the human body, the first coil can be directly placed between the cerebral cortex and the skull without the need for skull cutting and opening, and can fix the first coil. The role of the implant body.

Preferably, the protective cover of the first coil also contains a Bluetooth communication component, and the Bluetooth communication component is a Bluetooth chip antenna and a ceramic circuit board component carrying the Bluetooth chip antenna, or the Bluetooth communication component is predetermined. A wire antenna wound in a shape or a predetermined length, the Bluetooth communication component is encapsulated with an insulating material and then together with the first coil is encapsulated with the flexible material, and is passed through the pins of the feedthrough connector and the circuit mainboard. The first Bluetooth transceiver is connected.

Preferably, the first coil and the electrode connector are arranged on the same side of the metal shell, and the electrode connector and the protective cover of the first coil are integrally formed and fixed on the metal shell. On the side wall, the output end of the first coil is connected to the charging module and the data communication module on the circuit main board through the pins of the feed-through connector.

Preferably, the first coil and the electrode connector are arranged on both sides of the metal shell, the electrode connector is fixed on one side wall of the metal shell, and the protective cover of the first coil It is fixed on the other side wall of the metal shell. When the implant stimulator is implanted into the human body, the implant body is directly implanted on the skull without penetrating the skull.

Preferably, the electrode connector includes a connection socket and a connector housing arranged outside the connection socket. The connection socket includes a locking piece and an annular electrode contact, and the locking piece is used to fasten the As for the stimulation electrode, the annular electrode contact is composed of a plurality of metal rings and a metal spring coil located in the metal ring, an insulating ring is provided between two adjacent metal rings, and the end of the locking member is provided with There is an electrode protective cover.

Preferably, the electrode connector is directly bonded to the side wall of the metal housing, or a fixing block is provided on the side wall where the metal housing is connected to the electrode connector, and the electrode connector is When encapsulating, the epoxy resin or polyurethane (PU) is connected to the side wall of the metal shell through the fixing block.

Preferably, the first power source is a first rechargeable battery, the metal shell includes a first shell and a second shell that are matched and connected, the second shell is a bottom plate, and a protrusion is provided on the bottom plate. strips, the first rechargeable battery is placed within the range surrounded by the raised strips, the circuit mainboard is set up on the first rechargeable battery, the base plate, the first rechargeable battery and the circuit mainboard are Insulating materials are provided at the contact points for electrical isolation; the first housing is a box body, which is fastened to the second housing, and the second housing is connected to the first coil and the electrode. The side walls connected to the second housing are provided with through holes that match the feed-through connectors, and the feed-through connectors on both sides are installed in the corresponding through holes. The other two side walls of the second housing are provided with a third Two fixed hanging boards.

Preferably, the first power source is a first rechargeable battery, an ASIC chip, a first microprocessor, a first Bluetooth transceiver and an inertial measurement processor are provided on the circuit mainboard, and the current pulse generator is provided on the In the ASIC chip, the ASIC chip also includes a neural signal detection module, a wireless charging management module, a two-way radio frequency data communication module and a first power management module, the first Bluetooth transceiver, the inertial measurement processor, the The current pulse generator, the neural signal detection module, and the two-way radio frequency data communication module are all connected to the first microprocessor interface; the first microprocessor controls the input electrode selection of the neural signal detection module, The signal gain and frequency response range, the charging current and charging process output by the wireless charging management module, as well as the supply voltage, stimulation current, pulse width and pulse frequency of the current pulse generator.

Preferably, the first microprocessor sends the stimulation unit data packet including stimulation mode and stimulation amplitude to the stimulation unit control circuit of the current pulse generator in the form of instructions, and the stimulation unit control circuit transmits the stimulation amplitude value to the stimulation unit control circuit. The digital-to-analog converter of the current pulse generator converts the current value 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.

Preferably, the stimulation unit control circuit transmits the stimulation mode information of the stimulation unit data packet to the switching logic, and the switching logic controls the cathode and anode current output switches of the electrode driver and the switching of the loop electrode through the level shifter, The pulse width, pulse frequency, output polarity and output mode of the current stimulation pulse are thereby controlled via the input control signal.

Preferably, the number of the stimulation electrodes is 2, which can be used to stimulate the brain areas on both sides respectively. Each electrode contains at least 4 stimulation contacts; the neural signal detection module uses any two or more stimulation electrodes. The contact combination is used as a measuring electrode to detect the potential of the nerve region. The measured signal is stored in the internal memory of the implant as required or fed back to the multifunctional head crown through the two-way radio frequency data communication module and the first coil.

Preferably, the inertial measurement processor detects the patient's movement and heart rhythm changes, and feeds the measured signals to the multifunctional headband through the two-way radio frequency data communication module and the first coil.

Preferably, the ASIC chip, the microprocessor, the first Bluetooth transceiver and the inertial measurement processor are arranged on the same side of the circuit mainboard, and the first rechargeable battery is placed on the circuit The other side of the motherboard.

Preferably, the metal shell includes a first shell and a second shell that are matched and connected, and a pressure-sensitive film, a frame, and the first removable housing are arranged in sequence between the first shell and the second shell. The rechargeable battery, the rubber gasket and the circuit mainboard are matched and connected to the frame. The first rechargeable battery is placed in the frame, and a protective welding tape is provided around the frame.

Preferably, a PCB mounting board is vertically connected to the side of the circuit mainboard, the frame is divided into a first space and a second space, the first rechargeable battery is placed in the first space, and the second space The end side is an open end, and the feedthrough connector is matched and installed. The second space is provided with bumps along the side walls on both sides. Slots are provided on the bumps. The two ends of the PCB mounting board are plugged into the It is fixed in the slot, and the pins of the feed-through connector placed on the end side of the second space are connected to the mounting plate.

Preferably, the metal shell includes a first shell and a second shell that are matched and connected, and the first rechargeable battery and the circuit mainboard are placed between the first shell and the second shell. , the circuit mainboard is a rigid-flexible circuit board, which is bent and arranged around the first rechargeable battery.

Preferably, it also includes a mounting bracket, which includes a chassis, a cover plate and screws. Hanging lugs are provided on the edges of the chassis and the cover plate. Screw holes are provided on the hanging lugs, and the screws pass through the The screw hole can fix the base plate to the opening edge of the skull, the implant body is placed on the base plate, the cover plate covers the top of the implant body, and the screw passes through the cover plate The screw holes on the cover plate can fix the cover plate to the opening edge of the skull, and the surface of the implant body after installing the cover plate is approximately flush with the surface of the first coil.

Preferably, the first housing is provided with a plurality of first fixed hanging plates, and the first fixed hanging plates are provided with third screw holes.

Preferably, the second coil is a stranded cable made of multiple strands of insulated wires or a flat coil spirally wound by a single wire. The periphery of the second coil is injection molded and encapsulated with a flexible material and then sewn. At 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.

Preferably, the second power source is a second rechargeable battery, and the controller and the second rechargeable battery, and the controller and the second coil are respectively connected through flexible cables.

Preferably, the controller includes a second microprocessor, a second Bluetooth transceiver, a second power management module and a coil drive module, and the second microprocessor includes a signal processing module, a stimulation adjustment processing module and charging control firmware. Functional modules are respectively used to process and analyze the feedback signal of the implant stimulator, adjust the stimulation parameters according to the feedback signal and manage the charging process of the multifunctional headband to the implant; the coil drive module includes a coil drive circuit, a radio frequency A signal transceiver circuit and a coil induction charging control interface circuit. The second power management module includes a charging circuit for a second rechargeable battery, a charging input interface, a battery protection circuit and a voltage regulation circuit. The second Bluetooth transceiver provides multi-function Bluetooth communication channel for the crown.

Preferably, the second coil is sewn inside the insulating hat fabric corresponding to the position of the first coil of the implant, and the controller is a thin rigid-flexible circuit board encapsulated by epoxy resin, sewn on the multiple The second rechargeable battery is sewn inside the fabric on one side of the functional crown, and sewn on the other edge of the multifunctional crown.

The controller is provided with a radio frequency signal strength detection circuit to determine and remind whether the position of the multi-functional headband is offset.

Preferably, the doctor uses the program controller to set and adjust the stimulation prescription of the implant stimulator through Bluetooth communication together with the multi-function head crown, and the patient uses the remote controller to set and adjust the implant stimulator through Bluetooth communication. body stimulator for daily operation.

beneficial effects

Compared with the prior art, the present invention has the following advantages and effects: 1. The cranial implant stimulator provided by the present invention allows the implant to be fixed on the skull, greatly reducing the complexity of the implant surgery and eliminating the need for electrodes. The risk of infection and malfunction caused by lead extension can overcome the current clinical pain points, saving extra hours of surgical time for surgeons to dig tunnels to pull the electrode leads to the chest and connect them to the brain pacemaker, and The risk of infection during clinical treatment and the risk of failure due to electrode extension cord breakage. 2. The internal structure of the implant stimulator provided by the present invention is compact and reasonable, and the total thickness can be controlled within 6.5mm. It only needs to grind the skull of about 25mm*25mm. It does not require a complete opening of the skull, or even the need to penetrate the skull, and there is no need to touch it. The dura mater is dangerous, minimizing surgical trauma. 3. The flexible first coil in the implant stimulator and the flexible second coil in the multifunctional head crown according to the present invention can achieve close inductive coupling, which can effectively improve the charging efficiency of the implant stimulator battery and reduce the impact caused by the shell. The risk of temperature rise caused by the high radio frequency power consumption required for charging the internal coil. 4. The flexible first coil of the implant stimulator provided by the present invention is also used as a radio frequency data antenna, which effectively simplifies the physical structure of the implant stimulator and reduces the volume of the implant stimulator. 5. The centimeter-level short-distance radio frequency data communication implemented by the charging coil provided by the present invention effectively improves the safety of data exchange, and can be used in conjunction with the Bluetooth communication channel equipped with the multi-functional headband to charge the implant and remotely supercharge the device. The controller provides the possibility of dual-channel authentication. 6. Clinical trials have proven that the closed-loop stimulation modes of DBS (deep brain stimulation) and RNS (responsive nerve stimulation) have a significant effect on improving treatment effects. The present invention provides a novel real-time closed-loop stimulation mode, which is realized by the cooperation of an implant and a multi-functional head crown. Compared with the closed-loop control independently implemented by the implanted stimulator, the method of the present invention has more flexible characteristics, is not limited by the power consumption of the implant, and can realize algorithm adjustment more conveniently. 7. The implant stimulator and multifunctional head crown formation measurement, control and stimulation system provided by the present invention provide a natural and effective research platform for clinical research and brain-computer interface development. 8. The mounting bracket structure of the implant stimulator provided by the present invention further simplifies the device implantation operation and provides the implant with protection against impact risks.

Description of drawings

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

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

Figure 3a is a schematic diagram of the overall structure of the implant stimulator in the first embodiment of the present invention, and Figure 3b is an exploded schematic diagram of the implant stimulator in the first embodiment of the present invention;

Figures 4a and 4b are schematic diagrams of the internal structure of the implant stimulator in the first embodiment of the present invention;

Figure 5 is a schematic circuit diagram of an implanted stimulator in an embodiment of the present invention;

Figure 6 is a circuit schematic diagram of a stimulator pulse generator in an embodiment of the present invention;

Figure 7(a) is an internal assembly diagram of the metal case in the first embodiment of the present invention, and Figure 7(b) is an internal assembly diagram of the circuit motherboard installed in the metal case in the embodiment of the present invention;

Figure 8(a) is an internal assembly diagram of the metal case in the second embodiment of the present invention, and Figure 8(b) is an internal assembly diagram of the circuit motherboard installed in the metal case in the second embodiment of the present invention;

Figures 9(a) to 9(d) are respectively a top view, a side view, a front view and a perspective view of the circuit mainboard in the second embodiment of the present invention;

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

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

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

Figure 13(a) is a schematic diagram of the state of the implant stimulator before it is placed into the skull bone and sutured in the first embodiment of the present invention. Figure 13(b) is the edge of the implant stimulator in Figure 13(a) after it is installed. A schematic cross-sectional view in the A-A direction. Figure 13(c) is a schematic cross-sectional view along the B-B direction after the implant stimulator in Figure 13(a) is installed;

Figure 14(a) is a schematic diagram of the overall structure of the implant stimulator in the third embodiment of the present invention, and Figure 14(b) is an exploded schematic diagram of the implant stimulator in the third embodiment of the present invention;

Figure 15(a) is a schematic diagram of the overall structure of the implant stimulator in the fourth embodiment of the present invention. Figure 15(b) is an exploded schematic diagram of the implant stimulator in the fourth embodiment of the present invention. Figure 15(c) This is a schematic structural diagram of the metal shell in the fourth embodiment of the present invention;

Figure 16(a) is a schematic cross-sectional view of the implant stimulator after installation in the fourth embodiment of the present invention, and Figure 16(b) is a longitudinal cross-section after the implant stimulator is installed;

Figure 17 is a schematic structural diagram of a multifunctional head crown in an embodiment of the present invention;

Figure 18 is a schematic circuit diagram of a multifunctional headband in an embodiment of the present invention;

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

Figure 20 is a schematic diagram of the closed-loop mode of the brain nerve electrical stimulation system according to the embodiment of the present invention.

In the picture:

1-implant stimulator, 11-implant body, 111-metal shell, 1111-first shell, 1112-second shell, 1113-third through hole, 1114-protrusion, 1115-fixed Block, 112-circuit main board, 1121-mounting board, 1122-first through hole, 1123-first side, 1124-second side, 1125-third side, 1126-second through hole, 113-rubber gasket, 114-first rechargeable battery, 1141-positive/negative electrode, 115-frame, 1151-first space, 1152-second space, 1153-fixing column, 1154-bump, 1155-slot, 116-protective welding strip , 117-pressure-sensitive film, 118-electrode connector, 1181-connection socket, 1181a-locking piece, 1182-electrode contact, 1183-screw, 1184-seal, 1185-electrode protective cover, 1186-connector shell Body, 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 calvarium, 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 mounting ear, 621-First screw hole, 63-Screw, 64-Cover, 65-Second mounting Ear, 651-second screw hole, 7-first fixed hanging plate, 71-third screw hole, 8-scalp, 9-dura mater, 10-second fixed hanging plate.

Embodiments of the invention

The present invention will be further described below in conjunction with the accompanying drawings and examples.

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

Please refer to Figure 1, Figure 2 and Figure 3b. The present invention provides a brain nerve electrical stimulation system with sensing function, including an implant stimulator 1 that can be implanted through the skull, and a multifunctional head crown that can be directly worn. 2. The patient remote control 3 and the doctor's stimulation programmer 4. The multifunctional head crown 2 is preferably a hat that fits the size of the patient's head and can be worn on the patient's head; the implant stimulator 1 includes an implant body 11, a stimulation The electrode 13 and the first coil 12. The implant body 11 includes an electronic cavity sealed by a metal shell 111 and an electrode connector 118 encapsulated in a non-metallic material. The first coil 12 is arranged outside the metal shell 111 and inside the electronic cavity. A first power supply and a circuit mainboard 112 are provided. The circuit mainboard 112 is connected to the electrode connector 118. The electrode connector 118 is connected to the stimulation electrode 13. A current pulse generator is provided on the circuit mainboard 112. The current pulse output channel of the current pulse generator is The electrical pulse stimulation function is realized by connecting the electrode connector 118 to the stimulation electrode 13; the metal shell 111 is used as a return electrode for the current pulse. The multifunctional headband 2 includes a second coil 21, a second power source and a controller 22. In this embodiment, the second power source is a second rechargeable battery 23, the second coil 21, the second rechargeable battery 23 and the controller. 22 are sewn into a crown fabric suitable for the patient to wear, and are positioned through the brim of the crown. When the patient puts on the crown, the second coil 21 and the first coil 12 achieve close inductive coupling, charging the first power source and performing Radio frequency data communications. In this embodiment, the first power source is a first rechargeable battery 114, preferably a rechargeable lithium battery. The stimulation program controller 4 and the multifunctional headband 2 set a stimulation prescription for the implant stimulator 1 through Bluetooth communication, detect and analyze the working status of the implant stimulator 1, and communicate with the cloud server for data; the stimulation prescription Including parameters such as stimulation electrode contacts, stimulation mode, pulse frequency, and minimum/maximum current amplitude; the patient remote control 3 is used to allow the patient to exercise basic operational control over the implanted stimulator 1, including starting or ending stimulation, and adjusting stimulation. intensity, as well as starting or ending the charging process, etc.

The brain nerve electrical stimulation system provided by the embodiment of the present invention includes a transcranially installed implant stimulator 1 and a multifunctional head crown 2 suitable for long-term wear, which are connected with a stimulation program controller 4 for doctors and a remote control for patients. 3 form a novel brain nerve electrical stimulation system. The functional operation of the brain nerve electrical stimulation system is shown in Figure 2: In the first embodiment, please refer to Figures 3b, 4a and 4b, 2n independent currents are set on the circuit mainboard 112 of the implanted stimulator 1 Pulse generator, n is a positive integer not less than 4, 2n is an integer of eight or more, constitutes eight or more independently controllable current pulse stimulation channels, and at least eight are provided in the electrode connector 118 Ring-shaped electrode contact 1182. Ring-shaped electrode contact 1182 is composed of a metal ring and a metal spring ring located in the metal ring. An insulating ring is provided between every two adjacent metal rings. Through the feed-through connector 15 The pins connect each current pulse stimulation channel in the sealed electronic cavity to the corresponding contact point of the electrode connector 118. The electrode connector 118 constitutes the connection socket of the two n channels and is connected to all the electrode wires of the two stimulation electrodes 13 respectively. connection, each stimulation electrode 13 contains at least four stimulation contacts. Two stimulation electrodes with at least four contacts support dual-chamber deep brain stimulation, and each electrode stimulation contact also supports the application of neural signal detection. In other embodiments, more current pulse channels can also be provided, and a correspondingly larger number of electrode contacts 1182 are provided in the electrode connector 118, such as 16 electrode contacts 1182, and 8 electrodes on each side of the electrode connector 118. contacts to form two eight-channel connection sockets, and so on, or more such as 32 electrode contacts 1182, as long as the electrode connector 118 is of appropriate size. The implant stimulator 1 uses a small rechargeable battery, which can independently support continuous stimulation of 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 implanted stimulator 1 can also utilize the built-in nerve signal detection module and inertial measurement processor to realize the real-time closed-loop stimulation function together with the multi-functional headband 2 through radio frequency data connection. At the same time, the clinician can use the stimulation programmer 4 to adjust the stimulation prescription of the implant stimulator 1 through Bluetooth communication and the multifunctional head crown 2, and the patient can use the remote control 3 to select the stimulation prescription and adjust the stimulation intensity through Bluetooth communication. .

Figure 3a is a schematic diagram of the overall structure of the implant stimulator in the first embodiment of the present invention. Figure 3b is an exploded schematic diagram of the implant stimulator in the first embodiment of the present invention. Figures 4a and 4b are the first embodiment of the present invention. Schematic diagram of the internal structure of the implanted stimulator in the example.

Please refer to Figures 3a-4b. In the first embodiment, the implant stimulator 1 is composed of an implant body 11, two stimulation electrodes 13 and a first coil 12. The implant body 11 includes a titanium shell. The body 111 is a sealed electronic parts cavity and a PU (polyurethane) injection molded or epoxy resin encapsulated electrode connector 118. The sealed electronic cavity is equipped with the first medical rechargeable battery 114 and a circuit mainboard 112. The titanium metal shell 111 is Used as stimulation loop electrode in monopolar stimulation mode. Further, the first coil 12 is arranged outside the metal shell 111. The conductor of the first coil 12 is a cable made of twisted pure gold wires. The first coil 12 is spirally wound horizontally using the cable. It is injection molded from a biocompatible flexible material into a flexible flat coil with a protective sheath 121 with a thickness of less than 3 mm, and is integrated with the metal shell 111 with a flexible material. The flexible material is 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 mainboard 112 in the sealed electronic cavity through the pins of the feedthrough connector 15. When implanted into the human body, the first coil 12 can be directly placed on There is no craniotomy required for placement between the cerebral cortex and the skull, that is, there is no need to cut the skull, thereby reducing the craniotomy area and the skull surgical wound, and serving to fix the implant body 11. Further, a Bluetooth communication component is also provided in the protective cover 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 insulated with epoxy resin or other materials. After the material is encapsulated, the first coil 12 is encapsulated with a flexible material such as silicone or polyurethane, and is connected to the first Bluetooth transceiver of the circuit mainboard 112 through the pins of the feedthrough connector 15 .

Further, in the first embodiment, the first coil 12 and the electrode connector 118 are disposed on the same side of the metal housing 111. The electrode connector 118 and the protective cover 121 of the first coil 12 are integrally formed and fixed to the metal housing. 111 side walls.

The first coil 12 is set outside the metal shell 111 and is set as a thin coil encapsulated by a biocompatible flexible material such as silicone or polyurethane to achieve the following effects: 1) Compared with the structure in which the charging coil is set inside the metal shell, the charging coil is reduced in size. The size of the implanted stimulator thus reduces the requirement for the craniotomy area; 2) It is easy to install and can be placed directly between the skull and scalp, without occupying the craniotomy space, thereby reducing the skull surgical wound; 3) When implanted in the human body , which can play a role in fixing the main body of the implant. 4) Improve charging efficiency and reduce the risk of heating of the case during charging. 5) The first coil is also used as an inductively coupled data transmission antenna to achieve centimeter-level short-range data transmission. , improve the confidentiality performance of data communication. 6) Reduce the attenuation of communication signals and solve the problem that high-frequency signals cannot be transmitted in metal shells. Low-frequency transmission will increase the size of the antenna, which is not conducive to implanted products.

FIG. 5 is a schematic circuit diagram of the implanted stimulator in the embodiment of the present invention; FIG. 6 is a schematic circuit diagram of the stimulator pulse generator in the embodiment of the present invention.

Please refer to Figure 5. An ASIC chip, a first microprocessor (MCU), a first Bluetooth transceiver (BLE) and an inertial measurement processor (IMU) are provided on the circuit mainboard 112. The current pulse generator is located on the ASIC. Within the chip, the ASIC chip also includes a neural signal detection module, a wireless charging management module, a two-way radio frequency data communication module and a first power management module, the first Bluetooth transceiver, the inertial measurement processor, the current pulse The generator, the neural signal detection module, and the two-way radio frequency data communication module are all connected to the first microprocessor interface. The first microprocessor controls the input electrode selection and signal gain of the neural signal detection module. and frequency response range, the charging current and charging process output by the wireless charging management module, as well as the supply voltage, stimulation current, pulse width and pulse frequency of the current pulse generator.

Referring to Figure 6, the first microprocessor sends the 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 stimulation unit control circuit. The digital-to-analog converter of the current pulse generator converts the current value 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 the level shifter, thereby passing The input control signal controls the pulse width, pulse frequency, output polarity and output mode of the current stimulation pulse.

The nerve signal detection module can use any combination of two or more stimulation electrode contacts as measurement electrodes to detect nerve regional potential or cerebral electrocorticogram, and pass the measured signal through the two-way radio frequency data communication module and the first The coil 12 feeds back to the multifunctional headband 2. The inertial measurement processor monitors the patient's movement conditions, such as walking and sleeping. In addition, the inertial measurement processor can also detect the patient's heart rhythm changes, providing a possible tool for the detection of heart rhythm changes. The nerve signal detection module uses any two or more stimulation electrode contact combinations as measurement electrodes to detect nerve regional potentials. The measured signals are stored in the internal memory of the implant or through the two-way radio frequency data communication module as required. The first coil 12 is fed back to the multifunctional headband 2 for processing, and the first Bluetooth transceiver is used to receive commands from the patient's remote control 3, such as selecting stimulation prescription, setting stimulation intensity, and turning on/off stimulation, etc.

The invention utilizes a highly integrated multi-functional dedicated integrated circuit chip to realize the design of an ultra-small implantable stimulator with a volume close to 4 ml. The implant stimulator 1 contains 8 or more independent current pulse stimulation channels, and uses two at least 4-channel electrode connectors 118 to be connected to two stimulation electrodes 13 containing at least 4 stimulation contacts. The first rechargeable The battery 114 and the first coil 12 can be quickly charged. The craniotomy area required for implant surgery is limited to about 25mm*25mm, allowing the implant stimulator 1 to be implanted in the optimal implantation site of the human skull according to treatment needs, and to provide electrical stimulation for treating various parts of the cranial nerves, such as Subthalamic nucleus, medial part of the globus pallidus, hippocampus, etc., to treat diseases such as Parkinson's disease, epilepsy, and depression.

Figure 7(a) is an internal assembly diagram of the metal case in the first embodiment of the present invention, and Figure 7(b) is an internal assembly diagram of the circuit motherboard installed in the metal case in the first embodiment of the present invention.

Referring to 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, the first housing 1111 and the second housing 1112 are matched. The pressure-sensitive film 117, the frame 115, the first rechargeable battery 114, the rubber gasket 113 and the circuit main board 112 are arranged in sequence between the second housing 1112. The frame 115 and the circuit main board 112 are matched and connected. Further, a PCB mounting plate 1121 is vertically connected to the side of the circuit mainboard 112 for connecting the pins of the feedthrough connector 15 in the casing. The frame 115 is divided into a first space 1151 and a second space 1152. The first space 1151 The first rechargeable battery 114 is placed inside. The first rechargeable battery 114 can be arranged in a rectangular parallelepiped shape. The end side of the second space 1152 is an open end. The feedthrough connector 15 is matched and installed. The second space 1152 is along the side walls on both sides. A bump 1154 is provided, and a slot 1155 is provided on the bump 1154. Both ends of the PCB mounting board 1121 are plugged into the slot 1155 for fixation, and the pins of the feedthrough connector 15 are placed on the end side of the second space 1152. Connected to the mounting plate 1121, a protective welding strip 116 is provided on the periphery of the frame 115. The protective welding strip 116 surrounds the periphery of the frame 115 and is fixed against the feedthrough connector 15 at the end side of the second space 1152. Correspondingly, the second housing 1112 is also provided with an opening for the feedthrough connector 15 to be placed. 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 mainboard 112, and the first rechargeable battery 114 is placed On the other side of the main circuit board 112, the height of the space is reduced as much as possible to meet the requirement of not exceeding the thickness of the skull too much. The design is compact, so that the craniotomy size is about 25*25 mm, achieving a smaller incision for brain pacemaker implantation surgery. . The thickness of the metal shell 111 can be controlled at about 6 mm. A plurality of fixing posts 1153 with screw holes are provided on the side of the first space 1151 of the frame 115. Corresponding first through holes 1122 are provided on the circuit mainboard 112. Screws are used to pass through the first through holes 1122 to fix the fixing posts 1153. After removing the screw holes, fix the circuit mainboard 112 on the frame 115 while limiting the first rechargeable battery 112 to the first space 1151 .

Figure 8(a) is an internal assembly diagram of the metal case in the second embodiment of the present invention, and Figure 8(b) is an internal assembly diagram of the circuit motherboard installed in the metal case in the second embodiment of the present invention; Figure 9(a) - Figure 9(d) is respectively a top view, a side view, a front view and a perspective view of the circuit mainboard in the second embodiment of the present invention.

Please refer to Figures 8(a) to 9(d). In the second embodiment, the circuit mainboard 112 is a rigid-flexible circuit board, which is bent and surrounded by the first rechargeable battery 114. Specifically, , including 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 provided on the third side 1125, and a third side is provided on the second side 1124. Two through holes 1126, into which the protruding positive electrode/negative electrode 1141 at the end of the first rechargeable battery 114 is inserted. This structure makes the implant stimulator 1 smaller in size. This structure can ensure that the total thickness of the implant stimulator 1 meets the transcranial installation requirements even when the battery thickness is close to 5 mm. Other structures are similar to the first embodiment.

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

Please refer to Figures 10(a) to 11(d). In the first embodiment, the implant stimulator 1 also includes a mounting bracket 6. The mounting bracket 6 includes a chassis 61, a cover plate 64 and screws 63. The chassis 61 and Hanging lugs are provided on the edge of the cover plate 64, and screw holes are provided on the hanging lugs. Specifically, a plurality of first hanging lugs 62 are formed on the edge of the chassis 61. Preferably, the number of the first hanging lugs 62 is three. They are arranged outside the two long sides of the chassis 61. Each first hanging ear 62 is provided with a first screw hole 621; the cover plate 64 is matched and buckled on the chassis 61, and a plurality of second hanging ears are formed on the edge of the cover plate 64. 65. Preferably, the number of the second hanging ears 65 is three, which are arranged outside the two long sides of the cover plate 64. A second screw hole 651 is provided in each second hanging ear 65. After installation, the second hanging ear 65 and the first hanging ear 62 are arranged in a staggered manner. One side of the mounting bracket 6 includes two first hanging ears 62 and a second hanging ear 65 arranged between the two first hanging ears 62 . , the other side of the mounting bracket 6 includes two second hanging ears 65 and a first hanging ear 62 disposed between the two second hanging ears 65 . The screws 63 are used to fix the base plate 61 and the cover plate 64 to the opening edge of the skull 5 .

Figure 12(a) is a schematic diagram of the bracket chassis installed on the skull in the first embodiment of the present invention. Figures 12(b) and 12(c) are the insertion of the implant stimulator into the skull and the skull in the first embodiment of the present invention. A schematic diagram showing the space between the scalp and the main body of the implant being placed in the chassis. Figure 12(d) is a schematic diagram after the cover plate is placed on the chassis in the first embodiment of the present invention.

When implanting the implant stimulator 1 into the skull, the process of installing the implant stimulator 1 in the skull 5 through the mounting bracket 6 is as follows:

Please refer to Figure 12(a). First, use screws 63 to install the chassis 61 on the skull 5 through the first screw hole 621. Then, please refer to Figure 12(b) and Figure 12(c). Install the implant body 11 Placed on the chassis 61, the first coil 12 is placed between the scalp 8 and the skull 5. As shown in Figure 13(c), the thin flexible first coil 12 provided outside the implant body 11 can be directly placed on the skull 5 and the scalp 8, which not only facilitates installation, saves the skull opening area, but also serves to fix the implant body 11 installed in the skull; then, see Figure 12(d), cover the cover 64, and the cover 64 is The plate 64 covers the top of the implant body 11, so that the implant body 11 is enclosed in the cavity formed by the chassis 61 and the cover plate 64. The cover plate 64 is installed on the skull 5 through the second screw hole 651 with screws 63. superior. After the installation of the mounting bracket 6 is completed, it is shown in Figure 13(a) and Figure 13(b). After the cover plate 64 is installed, the surface of the implant body 11 is substantially flush with the surface of the first coil 12 .

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

Due to the ultra-thin structure of the implant stimulator 1, the total transcranial installation thickness of the implant body 11 including the installation bracket 6 does not exceed 4 mm. The human skull is generally 6-10mm, and Chinese people are relatively thin, at 6-8mm. Therefore, the implant stimulator 1 provided by the present invention can be safely fixed on the skull 5 and placed on the brain dura mater 9 to achieve the following Advantages: (1) Convenient surgery, reducing surgical trauma, eliminating the cumbersomeness and risks of electrode extension wires, overcoming adverse events such as infection and electrode lead breakage that are easy to occur in clinical treatment, and improving treatment effects. (2) Another advantage of implanting a brain pacemaker in the head is that it reduces the number of surgical steps and time required for clinicians to perform tunneling and threading of wires during implantation, and also reduces the risk of surgery, because there are arteries, veins, and veins near the patient's head and neck. As well as complex structures such as the vagus nerve, the risk of electrode leads passing through tunnels is high. (3) Another advantage is that it greatly simplifies the replacement and removal surgery of the implant stimulator 1, because the doctor only needs to take out the implant stimulator 1 on the head, and does not need to pull out the electrode extension lead, and at the same time subtracts This eliminates the risk of pulling out the electrode leads, because long-term implanted leads tend to form connective tissue with the surrounding areas in the patient's neck, and the doctor may need to separate them before pulling out the stimulation electrodes. The risk of surgery is high and the patient is traumatized.

Figure 14(a) is a schematic diagram of the overall structure of the implant stimulator in the third embodiment of the present invention, and Figure 14(b) is an exploded schematic diagram of the implant stimulator in the third embodiment of the present invention.

Please refer to Figure 14(a) and Figure 14(b). In the third embodiment, a plurality of first fixed hanging plates 7 are provided on the first housing 1111, which is different from the first and second embodiments. Yes, in this embodiment, there is no need to install the bracket 6, which simplifies the structure. Specifically, a first fixed hanging plate 7 is provided on three sides of the first housing 1111. A third screw hole 71 is provided on each first fixed hanging plate 7. A screw 63 is passed through the third screw hole 71 to secure the implant. The in-body stimulator 1 is fixed on the skull 5, and the first fixing hanging plate 7 can be fixed on the first shell 1111 by welding.

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

Please refer to Figure 15(a) and Figure 15(b). In the fourth embodiment, in order to separate the antenna signal from the stimulation signal and avoid mutual interference, the first coil 12 and the electrode connector 118 are separately located on the metal shell 111. On both sides, 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 pin of the feedthrough connector 151 to output the stimulation signal. The pin of the feedthrough connector 151 The number is 8; the first coil 12 is packaged with a flexible material such as silicone or polyurethane (PU) and is connected to the charging module, data communication module and first Bluetooth transceiver on the circuit mainboard 112 through the pins of the feedthrough connector 152 Connection, further, like the first embodiment, a Bluetooth communication component is provided in the protective cover 121. The Bluetooth communication component includes a Bluetooth chip antenna 122 and a ceramic circuit board 123 carrying the Bluetooth chip antenna 122. In other embodiments, The Bluetooth communication component can also be a wire antenna wound in a predetermined shape or a predetermined length. The Bluetooth communication component is encapsulated with epoxy resin or other insulating materials, and then together with the first coil 12 is encapsulated with flexible materials such as silicone or polyurethane (PU). The output end of the first coil 12 is connected to the charging module and the data communication module on the main circuit board 112 through the pins of the feed-through connector 152 , and the output end of the Bluetooth communication component is connected to the pins of the main circuit board 112 through the pins of the feed-through connector 152 . The first Bluetooth transceiver is connected, and 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.

The electrode connector 118 includes a connection socket 1181 and a connector housing 1186 arranged outside the connection socket 1181. The connector housing 1186 is preferably formed by infusion during encapsulation with epoxy resin. The connection socket 1181 includes a locking member 1181a and an annular electrode contact. At point 1182, a fourth through hole 1187 is provided on the front wall of the connector housing 1186. The fourth through hole 1187 allows the stimulation electrode 13 to be inserted into the connection socket 1181. The locking member 1181a and the electrode contact 1182 are placed on the connector housing 1186. Inside, the annular electrode contact 1182 is composed of a plurality of metal rings and a metal spring ring located in the metal ring. An insulating ring is provided between two adjacent metal rings. The connector housing 1186 is provided with a third Five through holes 1188, locking member 1181a, the locking member 1181a has a fourth screw hole 1189, the fourth screw hole 1189 and the fifth through hole 1188 are in corresponding positions, the screw 1183 penetrates the fifth through hole 1188 and the fourth screw hole 1183. After the hole 1189 is screwed, the stimulation electrode 13 is fastened in the connection socket 1181. A sealing member 1184 is inserted into the fifth through hole 1188 for sealing. Further, the metal ring and the insulating ring are bonded and fixed, and the end of the locking member 1181a The electrode protective cover 1185 is provided at the bottom, and the electrode protective cover 1185 can protect the stimulation electrode 13. The sealing member 1184 and the electrode protective cover 1185 are preferably made of silicone. There is a preliminary connection between the electrode protective cover 1185 and the locking member 1181a. Dot silicone to pre-fix, and then encapsulate and fix with epoxy resin or polyurethane (PU). Further, the electrode connector 118 can be directly bonded to the side wall of the metal shell 111, or a fixing block 1115 is provided on the side wall connecting the metal shell 111 and the electrode connector 118, and the electrode connector 118 is made of epoxy. When encapsulated in resin or polyurethane (PU), it is connected to the side wall of the metal shell 111 through the fixing block 1115 .

The implant stimulator 1 provided by this embodiment has a more reasonable arrangement of electronic components and circuit wiring, making the output signal of the implant stimulator 1 more effective, and at the same time increasing the manufacturability of the structure. When assembling this product Due to its ultra-small size, the difficulty index of various processes has increased. Taking into account the manufacturability and testability of the product during design is a prerequisite for ensuring product reliability.

Please continue to refer to Figure 15(b). In the fourth embodiment, the metal shell 111 includes a first shell 1111 and a second shell 1112 that are matched and connected. The second shell 1112 is a bottom plate, and convex strips are provided on the bottom plate. 1114. The first rechargeable battery 114 and the second housing 1112 are placed within the range surrounded by the protrusions 1114. The contact points between the first rechargeable battery 114 and the circuit board 112 are provided with insulating materials for electrical isolation, such as: protrusions 1114 Electrical insulating material is placed between the first rechargeable battery 114 and the first rechargeable battery 114 . The circuit mainboard 112 is installed on the first rechargeable battery 114. The first housing 1111 is a box body and is fastened to the second housing 1112. The first housing 1111 is connected to the first coil 12 and the electrode connector 118. A third through hole 1113 matching the feedthrough connectors 151 and 152 is opened on the side wall of the Second fixed hanging plates 10 are provided on both side walls, and are fixedly installed on the skull 5 through the second fixed hanging plates 10 .

Referring to Figures 16(a) and 16(b), the implant stimulator 1 disclosed in this embodiment is an implantation method in which the implant body 11 is implanted on the skull 5 without penetrating the skull 5. This structure requires the metal shell 111 of the implant body 11 to be increased in strength to be able to withstand the consequences of the implant body 11 protruding from the scalp, so the thickness of the metal shell 111 is increased for this purpose. Generally, the implant stimulator 1 The thickness of the shell is between 0.2-0.3mm. The thickness of the second shell 1112 of the lower shell of the metal shell 111 in this embodiment is 0.4-0.6mm. The thickness increases to 0.75mm around the edges. The thickness of the first shell 1111 increases. to 0.5mm to ensure the impact strength requirements. Therefore, when the implant stimulator 1 provided in this embodiment is implanted into the human body, the implant body 11 is directly implanted on the skull without penetrating the skull, and the first coil 12 and the electrode connector 118 are separately located in the metal shell. Both sides of the body 111 are more conducive to the effectiveness and accuracy of electronic signal transmission.

Figure 17 is a schematic structural diagram of a multi-functional head crown in an embodiment of the present invention; Figure 18 is a schematic circuit diagram of a multi-functional head crown in an embodiment of the present invention.

The present invention utilizes the characteristics of the head installation of the implanted stimulator 1 and the first coil 12 to equip the system with an important multi-functional head crown 2. Its purpose is to: 1) achieve high-efficiency charging and high-reliability short-distance two-way data Communication; 2) The multifunctional crown is designed to fit closely and comfortably with the patient's head when worn. When working together with the implant stimulator 1, no additional auxiliary fixation devices such as bandages are required, which does not affect the patient. Free movement; 3) Utilize the nerve signal and movement signal detection function of the implanted stimulator 1 to provide patients with real-time stimulation and a clinical data collection platform in a free movement environment through short-range two-way data communication; 4) Use implanted stimulation The neural signal and movement signal detection function of the device 1 helps realize the recording, processing and analysis of feedback signals through short-distance two-way data communication, and realizes the closed-loop control function of brain stimulation in a working environment that does not affect the battery power consumption of the implant.

Referring to Figure 17, the multifunctional headband 2 is provided with a second coil 21, a controller 22 and a second rechargeable battery 23. Between the controller 22 and the second rechargeable battery 23, the controller 22 and the second coil 21 are respectively connected by flexible cables 24. The multifunctional head crown 2 is a hat adapted to the size of the patient's head. The hat can be designed in various styles, and the present invention is not particularly limited to this. When the multifunctional headband 2 is worn, the second coil 21 covers the first coil 12, and the size of the second coil 21 and the design of the controller 22 should ensure that there is an appropriate margin of movement at the position where the headband is worn. The second coil 21 is a stranded cable made of multiple strands of insulated copper wire or a flat coil spirally wound by a single wire. The periphery of the second coil 21 is injection molded and encapsulated with silicone or other flexible materials and then sewn on the The controller 22 is a thin rigid-flexible circuit board encapsulated by epoxy resin or other insulating materials at an appropriate position in the fabric of the multi-function crown 2, and is sewn into the fabric on one side of the multi-function crown 2. The second Rechargeable battery 23 is sewn on the other edge of the crown. The second rechargeable battery 23 is preferably a rechargeable lithium battery. The capacity of the second rechargeable battery 23 is guaranteed to be able to fully charge the built-in first rechargeable battery 114 of the implant stimulator 1 for more than two times, or to continuously operate in the closed-loop stimulation mode for more than 12 hours. Charging of the second rechargeable battery 23 can be achieved through USB or a dedicated interface through the charging module circuit. The overall weight of the multifunctional crown 2, including the second rechargeable battery 23, does not exceed 250 grams, so that the patient is not affected by the feeling of weight when wearing the crown.

Referring to Figure 18, the controller 22 includes a second microprocessor, a second Bluetooth transceiver, a second power management module and a coil driving module. The second microprocessor includes a signal processing module, a stimulation adjustment processing module and a charging control. Functional modules are respectively used to process and analyze the feedback signal of the implant stimulator, adjust the stimulation parameters according to the feedback signal and manage the charging process of the multifunctional headband to the implant; the coil drive module includes a coil drive circuit, a radio frequency A 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 the coil drive circuit with The driving voltage and the adjustment voltage of other circuits are controllable. 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. The second Bluetooth transceiver provides a Bluetooth communication channel for the multifunctional headband 2 . The signal processing module is used to process 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 signal. Further, the coil driving module is provided with a safety support circuit to ensure radio frequency charging of the implant stimulator. In order to achieve the purpose of wearing it for a long time without affecting the patient's free movement, the design index of the coil drive module is high-efficiency power output and maintaining the surface temperature rise of the multi-functional headband 2 within a safe range. Furthermore, the controller is provided with a radio frequency signal strength detection circuit to determine and remind whether the position of the multi-functional headband is offset.

Therefore, the multifunctional headband 2 realizes the following functions: 1) acting as a charger for the implant stimulator 1: wirelessly charging the first rechargeable battery 114 in the implant stimulator 1 through coil coupling, 2) a communication hub: Conducts short-distance high-speed radio frequency data communication with the implant stimulator 1 through coil coupling, receives feedback data from the implant stimulator 1, and sends control commands. At the same time, it communicates with the doctor's program controller 4 and remote control through the Bluetooth channel. The program controller 4 is also equipped with a surgical mode, allowing the patient to transfer and implant the stimulator directly or through the multi-function crown 2 or the patient's remote controller during the patient's surgical recovery stage. 1 for data exchange. 3) Data processing and control center: records the data fed back by the implanted stimulator 1, processes and analyzes the feedback data in closed-loop mode, extracts information related to treatment, and decides on real-time adjustment of stimulation parameters.

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

The brain nerve electrical stimulation treatment system provided in this embodiment is provided with dual working modes, namely, the implanted stimulator autonomous stimulation mode and the system closed-loop mode.

In the autonomous stimulation mode, the open-loop working mode of implant stimulator 1 is the same as that of existing clinical implant stimulators. The operation process is shown in Figure 19: The implanted stimulator 1 sets the stimulation parameters and stimulation methods according to the stimulation prescription, including stimulation electrode contact combination, stimulation polarity, beat, pulse amplitude range, frequency, width, modulation method, etc. There can be multiple stimulation prescriptions. The stimulation parameters are determined according to the stimulation effect within the stimulation safety threshold during the initial debugging and testing phase after the stimulator implantation surgery. The patient can select and adjust the stimulation prescription through the remote control 3 according to the specific feeling and occasion needs. Stimulation intensity. The implanted stimulator 1 can automatically change the stimulation prescription or adjust the stimulation intensity according to the patient's posture and movement detected by the inertial sensor, but the patient can also change the stimulation prescription through the remote control 3 .

In this autonomous stimulation mode, a multifunctional headband 2 is required in two IPG operating states: implant stimulator charging and nerve potential recording. In addition, the system working mode can only be switched through the multi-function head crown.

The system closed-loop mode must be realized by the implant stimulator 1 and the multi-functional head crown 2. This system mode can be entered by command of the program controller 4 after wearing the headband 2 and entering system pairing. The workflow diagram of this mode is shown in Figure 20. In this mode, the stimulation prescription of the stimulator is still selected by the remote control 3, but the nerve signal detection function and the inertial measurement processor are activated, and the implant stimulator 1 transmits real-time nerve regional potential to the crown 2 through the radio frequency data channel. signal and patient action status signal. At the same time, the patient can also input some predetermined status instructions through the remote control 3, such as medication status, etc. The multi-functional headband 2 starts the signal processing and stimulation decision-making function, and based on the received feedback information, predefined The algorithm determines new stimulation parameters and sends them to the implant stimulator 1 in time through the radio frequency data channel.

In the closed-loop system mode, according to the remote control command, the head crown can be allowed to charge or terminate the charging of the implant stimulator battery at the same time.

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

Although the present invention has been disclosed above in terms of preferred embodiments, they are 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 present invention The scope of protection shall be determined by the claims.

Claims (26)

1. A brain nerve electrical stimulation system with sensing function, which is characterized by including an implant stimulator and stimulation electrode that can be implanted through the skull, a multifunctional head crown that can be directly worn, a patient remote control and a doctor's stimulation program control instrument;

   The implant stimulator includes an implant body and a first coil. The implant body includes an electronic cavity sealed by a metal shell and an electrode connector encapsulated in non-metallic materials. The first coil is disposed on Outside the metal shell, a first power supply and a circuit mainboard are provided in the electronic cavity, and a current pulse generator is provided on the circuit mainboard; the current pulse output channel of the current pulse generator is connected to the electrode connector through the electrode connector. The stimulation electrode connection realizes the electric pulse stimulation function; the metal shell is used as a return electrode for the current pulse;

   The multifunctional headband includes a second coil, a second power supply and a controller. The second coil, the second power supply and the controller are all sewn into a headband fabric suitable for the patient to wear. When the crown is put on, the second coil and the first coil charge the first power source through inductive coupling and perform radio frequency data communication as needed;

   The stimulation program controller communicates with the multi-function head crown through Bluetooth, sets stimulation prescriptions for the implant stimulator, detects and analyzes the working conditions of the implant stimulator, and communicates data with the cloud server; The stimulation prescription includes stimulation electrode contacts, stimulation mode, pulse width, pulse frequency, or/and, minimum/maximum amplitude;

   The patient remote control is used to allow the patient to exercise control over the implant stimulator, including starting or ending stimulation, adjusting stimulation intensity, inputting medication status, or/and starting or ending the charging process.
2. The brain nerve electrical stimulation system of claim 1, wherein 2n independent current pulse generators are provided on the main circuit board to form 2n independently controllable current pulse stimulation channels, and the electrodes 2n annular electrode contacts are provided in the connector, and each current pulse stimulation channel in the sealed electronic cavity is connected to the corresponding contact of the electrode connector through the pins of the feed-through connector, so The electrode connectors constitute two n-channel connection sockets, which are respectively connected to all electrode wires of the two stimulation electrodes. Each stimulation electrode contains n stimulation contacts, where n is a positive integer not less than 4.
3. The brain nerve electrical stimulation system of claim 1, wherein the conductor of the first coil is a cable made of twisted pure gold wires, and the first coil is spirally formed by using the cable. Horizontally wound and injection molded by a biocompatible flexible material into a flat coil with a protective sheath less than 3 mm thick, and integrated with the metal shell using the flexible material; the output of the first coil The end is connected to the charging module and data communication module on the circuit motherboard in the sealed electronic cavity through the pins of the feedthrough connector. When implanted into the human body, the first coil can be directly placed on the cerebral cortex and skull. There is no need to cut the skull opening, and it plays the role of fixing the implant body.
4. The brain nerve electrical stimulation system of claim 3, wherein the protective cover of the first coil also contains a Bluetooth communication component, and the Bluetooth communication component is a Bluetooth chip antenna and a device carrying the Bluetooth chip antenna. Ceramic circuit board assembly, or the Bluetooth communication assembly is a wire antenna wound in a predetermined shape or a predetermined length. The Bluetooth communication assembly is encapsulated with an insulating material and then together with the first coil is encapsulated with the flexible material, And connected to the first Bluetooth transceiver of the circuit mainboard through the pins of the feedthrough connector.
5. The brain nerve electrical stimulation system of claim 4, wherein the first coil and the electrode connector are disposed on the same side of the metal shell, and the electrode connector and the first The protective cover of the coil is integrally formed and fixed on the side wall of the metal shell. The output end of the first coil is connected to the charging module and data communication module on the circuit mainboard through the pins of the feedthrough connector.
6. The brain nerve electrical stimulation system of claim 4, wherein the first coil and the electrode connector are respectively arranged on both sides of the metal shell, and the electrode connector is fixed on the metal shell. On one side wall of the casing, the protective sheath of the first coil is fixed on the other side wall of the metal casing. When the implant stimulator is implanted into the human body, the implant body is directly implanted in the On the skull, there is no need to penetrate the skull.
7. The brain nerve electrical stimulation system of claim 6, wherein the electrode connector includes a connecting socket and a connector housing arranged outside the connecting socket, and the connecting socket includes a locking piece and a ring. A shaped electrode contact, the locking piece is used to fasten the stimulation electrode, the ring-shaped electrode contact is composed of a plurality of metal rings and a metal spring ring located in the metal ring, two adjacent metal rings An insulating ring is arranged between them, and an electrode protective sleeve is arranged at the end of the locking member.
8. The brain nerve electrical stimulation system of claim 6, wherein the electrode connector is directly bonded to the side wall of the metal shell, or the metal shell and the electrode connector A fixing block is provided on the connected side wall. When the electrode connector is encapsulated with epoxy resin or polyurethane (PU), it is connected to the side wall of the metal shell through the fixing block.
9. The brain nerve electrical stimulation system of claim 6, wherein the first power source is a first rechargeable battery, and the metal shell includes a first shell and a second shell that are matched and connected. The second housing is a bottom plate, and protrusions are provided on the bottom plate. The first rechargeable battery is placed within the range surrounded by the protrusions. The circuit mainboard is set up on the first rechargeable battery. The base plate, the contact point between the first rechargeable battery and the circuit mainboard are all provided with insulating materials for electrical isolation; the first shell is a box body, which is fastened to the second shell, and the The side wall of the second housing connected to the first coil and the electrode connector is provided with a through hole matching the feedthrough connector, and the feedthrough connectors on both sides are installed in the corresponding through holes, Second fixed hanging plates are provided on the other two side walls of the second housing.
10. The brain nerve electrical stimulation system of claim 1, wherein the first power source is a first rechargeable battery, and an ASIC chip, a first microprocessor, and a first Bluetooth transceiver are provided on the circuit mainboard. and an inertial measurement processor. The current pulse generator is located in the ASIC chip. The ASIC chip also includes a neural signal detection module, a wireless charging management module, a two-way 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 two-way radio frequency data communication module are all connected to the first microprocessor interface; the first The 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, as well as the supply voltage and stimulation current of the current pulse generator, pulse width and pulse frequency.
11. The brain nerve electrical stimulation system of claim 10, wherein the first microprocessor sends a stimulation unit data package including stimulation mode and stimulation amplitude to the stimulation unit of the current pulse generator in an instruction manner. Unit control circuit, 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 drive circuit. .
12. The brain nerve electrical stimulation system of claim 11, wherein the stimulation unit control circuit transmits the stimulation mode information of the stimulation unit data packet to the switching logic, and the switching logic is controlled by a level shifter. The cathode and anode current output switching of the electrode driver and the switching of the loop electrode thereby control the pulse width, pulse frequency, output polarity and output mode of the current stimulation pulse via the input control signal.
13. The brain nerve electrical stimulation system according to claim 10, characterized in that the number of the stimulation electrodes is 2, which can be used to stimulate the brain areas on both sides respectively, and each electrode contains at least 4 stimulation contacts; The nerve signal detection module uses any two or more stimulation electrode contact combinations as measurement electrodes to detect nerve regional potentials. The measured signals are stored in the internal memory of the implant or through the two-way radio frequency data communication module as required. and the first coil feeds back to the multifunctional head crown.
14. The brain nerve electrical stimulation system of claim 10, wherein the inertial measurement processor detects the patient's movement and heart rhythm changes, and passes the measured signals through the two-way radio frequency data communication module and the The first coil feeds back to the multifunctional headband.
15. The brain nerve electrical stimulation system of claim 10, wherein the ASIC chip, the microprocessor, the first Bluetooth transceiver and the inertial measurement processor are arranged on the circuit mainboard. On the same side, the first rechargeable battery is placed on the other side of the circuit board.
16. The brain nerve electrical stimulation system of claim 10, wherein the metal shell includes a first shell and a second shell that are matched and connected, and the first shell and the second shell A pressure-sensitive film, a frame, the first rechargeable battery, a rubber gasket and the circuit main board are arranged in sequence. The frame and the circuit main board are matched and connected, and the first rechargeable battery is placed in the frame. , a protective welding tape is provided around the frame.
17. The brain nerve electrical stimulation system of claim 16, wherein a PCB mounting board is vertically connected to the side of the main circuit board, and the frame is divided into a first space and a second space, and the first space The first rechargeable battery is placed inside, the end side of the second space is an open end, and a feedthrough connector is installed matchingly. The second space is provided with bumps along the side walls on both sides, and the bumps are provided with Slots, both ends of the PCB mounting board are plugged into the slots for fixation, and the pins of the feedthrough connector placed on the end side of the second space are connected to the mounting board.
18. The brain nerve electrical stimulation system of claim 10, wherein the metal shell includes a first shell and a second shell that are matched and connected, and the first shell and the second shell The first rechargeable battery and the circuit main board are placed therebetween. The circuit main board is a rigid-flexible circuit board, which is bent and surrounded by the first rechargeable battery.
19. The brain nerve electrical stimulation system according to claim 1, further comprising a mounting bracket, the mounting bracket includes a chassis, a cover plate and screws, and hanging lugs are provided on the edges of the chassis and the cover plate, A screw hole is provided on the hanging ear, and the screw can fix the chassis to the opening edge of the skull through the screw hole. The implant body is placed on the chassis, and the cover plate covers the opening edge of the skull. The top of the implant body, the screw can fix the cover plate to the opening edge of the skull through the screw hole on the cover plate, and the surface of the implant body after installing the cover plate is in contact with the first coil The surface is roughly flush.
20. The brain nerve electrical stimulation system according to claim 16 or 17, wherein a plurality of first fixed hanging plates are provided on the first housing, and third screws are provided on the first fixed hanging plates. hole.
21. The brain nerve electrical stimulation system of claim 1, wherein the second coil is a stranded cable made of multiple insulated wires or a flat coil spirally wound by a single wire. The periphery of the second coil is encapsulated by injection molding of a flexible material and then sewn in 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. The multifunctional crown In the wearing state, the second coil covers the first coil.
22. The brain nerve electrical stimulation system of claim 1, wherein the second power source is a second rechargeable battery, and between the controller and the second rechargeable battery, the controller and The second coils are connected through flexible cables.
23. The brain nerve electrical stimulation system of claim 22, wherein the controller includes a second microprocessor, a second Bluetooth transceiver, a second power management module and a coil driving module, and the second microprocessor The processor includes a signal processing module, a stimulation adjustment processing module and a charging control firmware function module, which are respectively used to process and analyze the feedback signal of the implant stimulator, adjust the stimulation parameters according to the feedback signal and manage the multi-function head crown to the implant. The charging process; the coil driving module includes a coil driving circuit, a radio frequency signal transceiver circuit and a coil induction charging control interface circuit; the second power management module includes a charging circuit for the second rechargeable battery, a charging input interface, and a battery protection circuit and a voltage adjustment circuit, the second Bluetooth transceiver provides a Bluetooth communication channel for the multifunctional headband.
24. The brain nerve electrical stimulation system of claim 22, wherein the second coil is sewn inside the insulating hat fabric corresponding to the position of the first coil of the implant, and the controller is made of epoxy resin. The encapsulated thin rigid-flexible circuit board is sewn into the fabric on one side of the multifunctional headband, and the second rechargeable battery is sewn on the other side of the multifunctional headband.
25. The brain nerve electrical stimulation system of claim 1, wherein the controller is provided with a radio frequency signal strength detection circuit for determining and reminding whether the position of the multifunctional headband is offset.
26. The brain nerve electrical stimulation system according to claim 1, characterized in that the doctor uses the program controller to set and adjust the stimulation prescription of the implant stimulator through Bluetooth communication and the multi-functional head crown. , the patient uses the remote control to perform daily operations on the implant stimulator through Bluetooth communication.