An implant stimulator

Abstract

The application discloses an implant stimulator, which comprises an implant body and a first coil arranged outside the implant body, wherein the implant 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 with a stimulating electrode through the electrode connector; and a multifunctional crown comprises a second coil, the second coil and the first coil are inductively coupled to charge the first power supply and transmit a data signal. The implant stimulator of the application removes the electrode lead extension line required in the deep brain implant system currently used in clinical practice, reduces the volume of the implant stimulator, reduces surgical trauma, and can be provided with a multifunctional crown without additional fixing measures, so that the implant stimulator can be quickly charged and safe data communication can be performed, and the treatment experience of patients is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to an implant stimulator. BACKGROUND

[0002] The brain neurostimulation implant currently used in clinical practice, i.e. brain pacemaker, due to its large volume, can only be implanted in front of the chest, resulting in the need for neurosurgeons to spend nearly 4 hours to make a subcutaneous tunnel to pass the electrode lead from the top of the brain to the front of the chest to connect the brain pacemaker. In the clinical use of patients implanted with brain pacemakers, the two electrode lead extension lines with a length of about 40-50 cm extending from the top of the brain to the front of the chest are the weakest implanted components, because the human head and neck will rotate countless times every day, and the breakage of the electrode lead extension line is a common adverse event in clinical practice. In addition, according to the individual constitution of the patient, the infection caused by the lead extending from the head to the chest is another type of common and safety-critical adverse event.

[0003] The patent CN103768712B of Beijing Pinchi Company describes a head-implanted deep brain stimulation system (DBS). In this invention, the IPG (pulse generator) of the brain pacemaker uses a small-capacity rechargeable battery, which is smaller in size and can be directly implanted in the skull, simplifying the implantation surgery and reducing the risk of lead breakage or infection caused by the long electrode lead. However, since the control circuit of the IPG is composed of discrete components, and a built-in charging coil is used, the size is limited, and the built-in charging antenna affects the charging efficiency. Although the patent mentions the possible configuration of an external charging coil, the charging and data communication still use different antennas, and the size is still limited, requiring a larger craniotomy size during implantation.

[0004] The patent CN108290045A of Boston Scientific Corporation in China discloses a skull-mounted brain pacemaker. The principle can make the volume smaller, but its IPG does not have a battery and needs external supporting devices for uninterrupted power supply, which is hard to apply clinically. Moreover, it uses an external electrode connector, which limits the size of the electrode connector, increasing the complexity and infection risk of the skull implantation surgery.

[0005] In addition, the IPG device mounted on the skull is easily damaged by impact when hitting hard objects. The IPG fixation devices of the above two inventions do not provide such protection. In terms of function, neither of the two IPGs includes a feedback method for neural signals or other signals, so there is no possibility of closed-loop stimulation control. SUMMARY

[0006] The technical problem to be solved by the present application is to provide an implant stimulator, simplify the structure of the implant stimulator, reduce the volume of the implant stimulator, reduce surgical trauma, and at the same time, provide an external control device that is convenient to wear, can be quickly charged, can perform data secure communication, and improves the treatment experience.

[0007] To solve the above technical problems, the present application provides an implant stimulator, which comprises an implant body and a first coil, the implant body comprises an electronic cavity sealed by a metal shell and an electrode connector packaged 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, and a current pulse generator is arranged on the circuit mainboard; a current pulse output channel of the current pulse generator is connected with the stimulating electrode through the electrode connector to realize an electric pulse stimulation function; and the metal shell is used as a loop electrode of the current pulse.

[0008] Preferably, 2n independent current pulse generators are arranged on the circuit mainboard to form 2n independently controllable current pulse stimulation channels, 2n annular electrode contacts are arranged in the electrode connector, each current pulse stimulation channel in the sealed electronic cavity is connected to a corresponding contact of the electrode connector through a pin of a feedthrough connecting piece, the electrode connector forms a two-n-channel connecting socket, and all electrode leads of two stimulating electrodes are connected to the connecting socket, each stimulating electrode comprises n stimulating contacts, and n is a positive integer not less than 4.

[0009] Preferably, the conductor of the first coil is a cable twisted by a plurality of pure gold wires, the first coil is a flat coil with a protective sleeve, which is spirally and horizontally wound by the cable and injection-molded by a biocompatible flexible material to a thickness of less than 3 mm, and is integrated with the metal shell by the flexible material; an output end of the first coil is connected with a charging module and a data communication module on the circuit mainboard in the sealed electronic cavity through a pin of a feedthrough connecting piece, and when implanted in the human body, the first coil can be directly placed between the cerebral cortex and the skull without the need for a skull cutting opening and plays a role in fixing the implant body.

[0010] Preferably, the protective sleeve of the first coil further comprises a Bluetooth communication component, 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 a wire antenna wound in a predetermined shape or a predetermined length, the Bluetooth communication component is packaged with an insulating material and then packaged with the first coil by the flexible material, and is connected with a first Bluetooth transceiver of the circuit mainboard through a pin of a feedthrough connecting piece.

[0011] Preferably, the first coil and the electrode connector are arranged on the same side of the metal shell, the electrode connector and the protective sleeve of the first coil are integrally formed and fixed to the side wall of the metal shell, and the top surface of the electrode connector is fixedly connected with the protective sleeve of the first coil, and the output end of the first coil is connected with the charging module and the data communication module on the circuit mainboard through the pin of the feedthrough connecting piece.

[0012] Preferably, the first coil and the electrode connector are arranged on the same side of the metal shell, the electrode connector and the protective sleeve of the first coil are integrally formed and fixed to the side wall of the metal shell, and the top surface of the electrode connector is fixedly connected with the protective sleeve of the first coil, and the output end of the first coil is connected with the charging module and the data communication module on the circuit mainboard through the pin of the feedthrough connecting piece.

[0013] Preferably, the electrode connector comprises a connecting socket and a connector housing arranged outside the connecting socket, the connecting socket comprises a locking piece and a ring-shaped electrode contact, the locking piece is used for fastening the stimulating electrode, the ring-shaped electrode contact is composed of a plurality of metal rings and a metal spring ring arranged in the metal ring, an insulating ring is arranged between adjacent two metal rings, and an electrode protective sleeve is arranged at the end of the locking piece.

[0014] Preferably, the electrode connector is directly bonded to the side wall of the metal shell, or a fixing block is arranged on the side wall of the metal shell connected with the electrode connector, and the electrode connector is connected to the side wall of the metal shell through the fixing block when the electrode connector is encapsulated by epoxy resin or polyurethane (PU).

[0015] Preferably, the first power supply is a first rechargeable battery, the metal shell comprises a first shell and a second shell connected in a matching manner, the second shell is a bottom plate, a protruding strip is arranged on the bottom plate, the first rechargeable battery is placed in the range surrounded by the protruding strip, the circuit mainboard is arranged on the first rechargeable battery, and insulating materials are arranged at the contact positions of the bottom plate, the first rechargeable battery and the circuit mainboard for electrical isolation; the first shell is a box body, which is buckled on the second shell, the second shell is provided with through holes matched with the feedthrough connecting pieces on the side walls connected with the first coil and the electrode connector, the feedthrough connecting pieces on both sides are installed in the corresponding through holes, and second fixing hanging plates are arranged on the other two side walls of the second shell.

[0016] Preferably, the first power supply is a first rechargeable battery, the circuit board is provided with an ASIC chip, a first microprocessor, a first Bluetooth transceiver and an inertial measurement processor, the current pulse generator is arranged in the ASIC chip, the ASIC chip further comprises 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; 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.

[0017] Preferably, the first microprocessor sends a stimulation unit data packet containing a stimulation mode and a stimulation amplitude to the stimulation unit control circuit of the current pulse generator in an instruction manner, 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.

[0018] Preferably, the stimulation unit control circuit transmits the stimulation mode information of the stimulation unit data packet to the switch logic, the switch logic controls the switching of the cathode and anode current output switches of the electrode driver and the return electrode through the level shifter, thereby controlling the pulse width, pulse frequency, output polarity and output mode of the current stimulation pulse through the input control signal.

[0019] Preferably, the number of stimulation electrodes is 2, which can be used to stimulate the brain regions on both sides, and each electrode contains at least 4 stimulation contacts; the neural signal detection module uses any two or more stimulation electrode contacts in combination as a measurement electrode to detect the potential of the neural region, and the measured signal is stored in the internal memory of the implant or fed back to the external device through the bidirectional radio frequency data communication module and the first coil.

[0020] Preferably, the inertial measurement processor detects the patient's motion and heart rate changes, and feeds back the measured signals to the external device through the bidirectional radio frequency data communication module and the first coil.

[0021] Preferably, the ASIC chip, the microprocessor, the first Bluetooth transceiver and the inertial measurement processor are arranged on the same side of the circuit board, and the first rechargeable battery is placed on the other side of the circuit board.

[0022] Preferably, the metal shell comprises a first shell and a second shell connected in a matching manner, and the first shell and the second shell are sequentially provided with a pressure-sensitive adhesive sheet, a frame, the first rechargeable battery, a rubber gasket and the circuit mainboard, the frame and the circuit mainboard are connected in a matching manner, the first rechargeable battery is placed in the frame, and a protective solder strip is arranged on the periphery of the frame.

[0023] Preferably, the side edge of the circuit mainboard is vertically connected to a PCB mounting plate, the frame is divided into a first space and a second space, the first rechargeable battery is placed in the first space, the second space is open-ended, a feedthrough connecting piece is matched and mounted, the second space is provided with a protrusion on the side wall on both sides, a slot is arranged on the protrusion, the two ends of the PCB mounting plate are inserted into the slot for fixation, and the pin of the feedthrough connecting piece placed at the end side of the second space is connected with the mounting plate.

[0024] Preferably, the metal shell comprises a first shell and a second shell connected in a matching manner, and the first shell and the second shell are sequentially provided with the first rechargeable battery and the circuit mainboard, the circuit mainboard is a rigid-flexible combined circuit board, and is bent to surround the periphery of the first rechargeable battery.

[0025] Preferably, the installation support comprises a bottom disc, a cover plate and a screw, the edges of the bottom disc and the cover plate are provided with hanging ears, the hanging ears are provided with screw holes, the screw can fix the bottom disc to the opening edge of the skull through the screw holes, the implant body is placed on the bottom disc, the cover plate covers the top of the implant body, the screw can fix the cover plate to the opening edge of the skull through the screw holes on the cover plate, and the surface of the implant body after the cover plate is installed is substantially flush with the surface at the first coil.

[0026] Preferably, a plurality of first fixed hanging plates are arranged on the first shell, and the first fixed hanging plates are provided with third screw holes.

[0027] The present application has the following advantages over the prior art: 1. The cranial implant stimulator provided by the present application allows the implant to be fixed to the skull, greatly reducing the complexity of the implant surgery, eliminating the risk of infection and failure caused by the electrode lead extension line, overcoming the current clinical pain points, saving the additional hours of surgery time for neurosurgery doctors to tunnel the electrode lead to the chest and connect it to the brain pacemaker, and reducing the risk of infection and electrode extension line breakage during clinical treatment. 2. The internal structure of the implant stimulator provided by the present application is compact and reasonable, and the total thickness can be controlled within 6.5mm, only about 25mm*25mm of skull grinding mouth is needed, without the need for complete skull opening, even without the need to punch through the skull, without touching the dura mater, and the surgical trauma is minimized. 3. The flexible first coil in the implant stimulator and the flexible second coil in the multifunctional crown in the present application can achieve tight inductive coupling, which can effectively improve the charging efficiency of the implant stimulator battery and reduce the risk of temperature rise caused by high radio frequency power consumption of the coil built-in shell. 4. The flexible first coil of the implant stimulator provided by the present application is 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-range radio frequency data communication realized by the charging coil effectively improves the safety of data exchange, and can cooperate with the Bluetooth communication channel equipped in the multifunctional crown to provide the possibility of dual-channel authentication for implant charging and remote override. 6. Clinical trials have shown that the closed-loop stimulation mode of DBS (deep brain electrical stimulation therapy) and RNS (reactive neural electrical stimulation) has a significant effect on improving treatment effect. The present application provides a novel real-time closed-loop stimulation mode realized by cooperation of the implant and the multifunctional crown. Compared with the closed-loop control realized by the implant stimulator independently, the method has more flexible characteristics and is not limited by the power consumption of the implant, and the algorithm adjustment can be more conveniently realized. 7. The measurement, control and stimulation system formed by the implant stimulator and the multifunctional crown provided by the present application provides 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 application further simplifies the device implant surgery and provides protection for the implant against impact risk. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1 The whole structure schematic diagram of the brain neural electrical stimulation system in the embodiment of the present application is shown in the figure;

[0029] Figure 2 The frame schematic diagram of the brain neural electrical stimulation system in the embodiment of the present application is shown in the figure;

[0030] Figure 3a The whole structure schematic diagram of the implant stimulator in the first embodiment of the present application is shown in the figure, Figure 3bFig. 1 is a schematic diagram of the disassembly of the implant stimulator in the first embodiment of the present application;

[0031] Figure 4a and Figure 4b Fig. 2 is a schematic diagram of the internal structure of the implant stimulator in the first embodiment of the present application;

[0032] Figure 5 Fig. 3 is a schematic diagram of the circuit of the implant stimulator in the first embodiment of the present application;

[0033] Figure 6 Fig. 4 is a schematic diagram of the circuit of the pulse generator of the stimulator in the first embodiment of the present application;

[0034] Figure 7 (a) is an internal assembly diagram of the metal shell in the first embodiment of the present application, Figure 7 (b) is an internal assembly diagram of the metal shell in the first embodiment of the present application,

[0035] Figure 8 (a) is an internal assembly diagram of the metal shell in the second embodiment of the present application, Figure 8 (b) is an internal assembly diagram of the metal shell in the second embodiment of the present application,

[0036] Figure 9 (a)- Figure 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 application;

[0037] Figure 10 (a), Figure 10 (b), Figure 10 (c), Figure 10 (d) are respectively a side view, a top view, a perspective view and a front view of the implant mounting bracket base plate in the first embodiment of the present application;

[0038] Figure 11 (a), Figure 11 (b), Figure 11 (c), Figure 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 application;

[0039] Figure 12 (a) is a schematic diagram of the installation of the bracket base plate on the head in the first embodiment of the present application, Figure 12 (b), Figure 12 (c) is a schematic diagram of the insertion of the implant stimulator between the skull and the scalp and the placement of the implant body into the base plate in the first embodiment of the present application, Figure 12 (d) is a schematic diagram of the covering of the base plate with the cover plate in the first embodiment of the present application;

[0040] Figure 13 (a) is a schematic diagram of the state of the implanted body stimulator before it is implanted in the skull and sutured to the scalp in the first embodiment of the present application, Figure 13 (b) is a schematic diagram of the implanted body stimulator in the first embodiment of the present application, Figure 13 (a) is a schematic diagram of the implanted body stimulator after it has been implanted in the skull and sutured to the scalp in the first embodiment of the present application, Figure 13 (c) is a schematic diagram of the implanted body stimulator after it has been implanted in the skull and sutured to the scalp in the first embodiment of the present application, Figure 13 (a) is a schematic diagram of the implanted body stimulator after it has been implanted in the skull and sutured to the scalp in the first embodiment of the present application,

[0041] Figure 14 (a) is a schematic diagram of the implanted body stimulator in the third embodiment of the present application, Figure 14 (b) is a schematic diagram of the implanted body stimulator in the third embodiment of the present application,

[0042] Figure 15 (a) is a schematic diagram of the implanted body stimulator in the fourth embodiment of the present application, Figure 15 (b) is a schematic diagram of the implanted body stimulator in the fourth embodiment of the present application, Figure 15 (c) is a schematic diagram of the implanted body stimulator in the fourth embodiment of the present application,

[0043] Figure 16 (a) is a schematic diagram of the implanted body stimulator after it has been implanted in the skull and sutured to the scalp in the fourth embodiment of the present application, Figure 16 (b) is a schematic diagram of the implanted body stimulator after it has been implanted in the skull and sutured to the scalp in the fourth embodiment of the present application,

[0044] Figure 17 is a schematic diagram of the structure of the multifunctional head crown in the embodiment of the present application,

[0045] Figure 18 is a schematic diagram of the circuit of the multifunctional head crown in the embodiment of the present application,

[0046] Figure 19 is a schematic diagram of the autonomous mode of the brain nerve electrical stimulation system in the embodiment of the present application,

[0047] Figure 20 is a schematic diagram of the closed loop mode of the brain nerve electrical stimulation system in the embodiment of the present application.

[0048] In the drawings:

[0049] 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 mainboard, 1121-mounting plate, 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, 115-frame, 1151-first space, 1152-second space, 1153-fixing column, 1154-bump, 1155-slot, 116-protection solder strip, 117-pressure sensitive adhesive sheet, 118-electrode connector, 1181-connection socket, 1181a-locking piece, 1182-electrode contact, 1183-screw, 1184-sealing piece, 1185-electrode protection sleeve, 1186-connector shell, 1187-fourth through hole, 1188-fifth through hole, 1189-fourth screw hole, 12-first coil, 121-protection sleeve, 122-Bluetooth chip antenna, 123-ceramic circuit board, 13-stimulating electrode, 131-electrode skull cap, 15, 151, 152-feedthrough connector, 2-multifunctional head crown, 21-second coil, 22-controller, 23-second rechargeable battery, 24-flexible cable, 3-remote controller, 4-programmed instrument, 5-skull, 6-mounting support, 61-bottom disc, 62-first hanging ear, 621-first screw hole, 63-screw, 64-cover plate, 65-second hanging ear, 651-second screw hole, 7-first fixed hanging plate, 71-third screw hole, 8-scalp, 9-dura mater, 10-second fixed hanging plate. DETAILED DESCRIPTION

[0050] The application will be further described below in connection with the drawings and examples.

[0051] Figure 1 The figure is a schematic diagram of the overall structure of the brain nerve electric stimulation system in the embodiment of the application. Figure 2 The figure is a schematic diagram of the functional framework of the brain nerve electric stimulation system in the embodiment of the application.

[0052] See Figure 1 , Figure 2 and Figure 3bThe application provides a brain nerve electric stimulation system with sensing function, which comprises an implant stimulator 1 capable of being implanted through a skull, a multifunctional head crown 2 capable of being directly worn, a patient remote controller 3 and a stimulation program control instrument 4 for doctors, the multifunctional head crown 2 is preferably a hat suitable for the size of the patient's skull and can be worn on the patient's head; the implant stimulator 1 comprises an implant main body 11, a stimulation electrode 13 and a first coil 12, the implant main body 11 comprises an electronic cavity sealed by a metal shell 111 and an electrode connector 118 encapsulated by a non-metal material, the first coil 12 is arranged outside the metal shell 111, a first power supply and a circuit main board 112 are arranged in the electronic cavity, the circuit main board 112 is connected with the electrode connector 118, the electrode connector 118 is connected with the stimulation electrode 13, a current pulse generator is arranged on the circuit main board 112, a current pulse output channel of the current pulse generator is connected with the stimulation electrode 13 through the electrode connector 118 to realize an electric pulse stimulation function; the metal shell 111 is used as a loop electrode of the current pulse. The multifunctional head crown 2 comprises a second coil 21, a second power supply and a controller 22, in the 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 in a head crown fabric suitable for being worn by the patient, and are positioned through a head crown brim, when the patient wears the head crown, the second coil 21 and the first coil 12 realize close inductive coupling, charge the first power supply and perform radio frequency data communication. In the embodiment, the first power supply is a first rechargeable battery 114, preferably a rechargeable lithium battery. The stimulation program control instrument 4 sets a stimulation prescription for the implant stimulator 1 together with the multifunctional head crown 2 through Bluetooth communication, detects and analyzes the working condition of the implant stimulator 1 and exchanges data with a cloud server; the stimulation prescription comprises parameters such as a stimulation electrode contact, a stimulation mode, a pulse frequency and minimum / maximum current amplitude; the patient remote controller 3 is used for enabling the patient to exercise basic operation control on the implant stimulator 1, including starting or terminating stimulation, adjusting stimulation intensity and starting or terminating a charging process.

[0053] The brain nerve electric stimulation system provided by the embodiment of the application comprises the implant stimulator 1 installed through the skull and the multifunctional head crown 2 suitable for being worn for a long time, and they form a novel brain nerve electric stimulation system together with the stimulation program control instrument 4 for doctors and the remote controller 3 for patients. Figure 3b 、 Figure 4a and Figure 4b, the circuit mainboard 112 of the implant stimulator 1 is provided with 2n independent current pulse generators, n is a positive integer not less than 4, 2n is an integer of eight or more, and eight or more independently controllable current pulse stimulation channels are formed. The electrode connector 118 is provided with at least eight annular electrode contacts 1182, which are composed of a metal ring and a metal spring ring located in the metal ring. An insulating ring is arranged between each two adjacent metal rings. Each current pulse stimulation channel in the sealed electronic cavity is connected to the corresponding contact of the electrode connector 118 through the pin of the feedthrough connecting piece 15. The electrode connector 118 forms a two-n-channel connecting socket and is connected with all electrode leads of the two stimulation electrodes 13 respectively. Each stimulation electrode 13 contains at least four stimulation contacts. The two at least four-contact stimulation electrodes support dual-cavity deep brain stimulation, and each electrode stimulation contact simultaneously supports the application of neural signal detection. In other embodiments, more current pulse channels can also be provided, and the electrode connector 118 is provided with a corresponding larger number of electrode contacts 1182, such as 16 electrode contacts 1182, 8 electrode contacts on each side of the electrode connector 118, forming two eight-channel connecting sockets, and the like, 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 crown 2. The implant stimulator 1 can also use the built-in neural signal detection module and inertial measurement processor to realize real-time closed-loop stimulation function together with the multifunctional crown 2 through radio frequency data connection. At the same time, the clinician can use the stimulation program control instrument 4 to adjust the stimulation prescription of the implant stimulator 1 through Bluetooth communication together with the multifunctional crown 2, and the patient can use the remote controller 3 to select the stimulation prescription and adjust the stimulation intensity through Bluetooth communication.

[0054] Figure 3a It is a schematic diagram of the overall structure of the implant stimulator in the first embodiment of the present application, Figure 3b It is a schematic diagram of the overall structure of the implant stimulator in the first embodiment of the present application, Figure 4a And Figure 4b It is a schematic diagram of the internal structure of the implant stimulator in the first embodiment of the present application.

[0055] Please see Figure 3a - Figure 4bIn the first embodiment, the implant stimulator 1 is composed of an implant body 11, two stimulating electrodes 13 and a first coil 12. The implant body 11 includes an electronic cavity sealed by a titanium metal shell 111 and a PU (polyurethane) injection or epoxy encapsulated electrode connector 118. The sealed electronic cavity contains a medical first rechargeable battery 114 and a circuit mainboard 112. The titanium metal shell 111 is used as a stimulating 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 twisted by pure gold wires. The first coil 12 is spirally and horizontally wound by the cable, and is injection molded by a biocompatible flexible material into a flexible flat coil with a protective sleeve 121 with a thickness less than 3 mm. The first coil 12 is integrated with the metal shell 111 by a flexible material, which is preferably 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 circuit mainboard 112 in the sealed electronic cavity through the pins of the feedthrough connector 15. When implanted in the human body, the first coil 12 can be directly placed between the cerebral cortex and the skull without craniotomy, i.e. without a skull cutting opening, thereby reducing the craniotomy area and skull surgical incision, and playing a role in fixing the implant body 11. Further, the protective sleeve 121 outside the first coil 12 is also provided with a Bluetooth communication component, which 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 or other insulating materials, and then encapsulated with the first coil 12 by a flexible material such as silicone or polyurethane, and connected to the first Bluetooth transceiver of the circuit mainboard 112 through the pins of the feedthrough connector 15.

[0056] Further, in the first embodiment, the first coil 12 and the electrode connector 118 are arranged on the same side of the metal shell 111. 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 shell 111, and the top surface of the electrode connector 118 is bonded to the protective sleeve 121 of the first coil 12.

[0057] The first coil 12 is arranged outside the metal shell 111 and is a thin coil encapsulated by a biocompatible flexible material such as silicone or polyurethane, which has the following effects: 1) compared with the structure in which the charging coil is arranged in the metal shell, the volume of the implanted stimulator is reduced, thereby reducing the requirement for the craniotomy area; 2) the implanted stimulator can be directly placed between the skull and the scalp, without occupying the craniotomy space, thereby reducing the craniotomy incision; 3) when implanted in the human body, the first coil can play a role in fixing the main body of the implanted stimulator; 4) the charging efficiency is improved, and the risk of heating of the metal shell during charging is reduced; 5) the first coil is used as an inductive coupling type data transmission antenna, cm-level short-distance data transmission is achieved, and the data communication security performance is improved; and 6) the attenuation of the communication signal is reduced, and the problems that high-frequency signals cannot be transmitted in the metal shell and that low-frequency transmission increases the volume of the antenna and is not conducive to the implantation of the product are solved.

[0058] Figure 5 The circuit schematic diagram of the implanted stimulator in the embodiment of the present application is shown in FIG. 1. Figure 6 The circuit schematic diagram of the stimulator pulse generator in the embodiment of the present application is shown in FIG. 2.

[0059] Referring to FIG. 1, Figure 5 The ASIC chip, the first microprocessor (MCU), the first Bluetooth transceiver (BLE), and the inertial measurement processor (IMU) are arranged on the circuit mainboard 112. The current pulse generator is arranged in the ASIC chip. The ASIC chip further 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 in an interface manner. The first microprocessor controls the input electrode selection, signal gain, and frequency response range of the neural signal detection module, the output of the charging current and the charging process of the wireless charging management module, and the power supply voltage, stimulation current, pulse width, and pulse frequency of the current pulse generator.

[0060] Referring to FIG. 1, Figure 6 The first microprocessor sends the stimulation unit data packet containing the stimulation mode and the stimulation amplitude to the stimulation unit control circuit of the current pulse generator in the form of an instruction. The stimulation unit control circuit transmits the stimulation amplitude value to the digital-to-analog converter of the current pulse generator to convert the stimulation amplitude value into a current value, and then converts the current value 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 switch logic. The switch logic controls the switching of the cathode and anode current output switches of the electrode driver and the return electrode through the level shifter, so as to control the pulse width, pulse frequency, output polarity, and output mode of the current stimulation pulse through the input control signal.

[0061] The neural signal detection module can detect the neural field potential or electrocorticogram using any two or more combinations of the stimulation electrode contacts as measurement electrodes. The detected signals are stored in the internal memory of the implant or fed back to the external device - the multi-functional head crown 2 through the bidirectional RF data communication module and the first coil 12. The inertial measurement processor monitors the patient's motion, such as walking and sleeping, etc. In addition, the inertial measurement processor can also detect the patient's heart rate variability, providing a possible tool for heart rate variability detection. These signals are fed back to the multi-functional head crown 2 through the bidirectional RF data communication module and the first coil 12 for processing. The first Bluetooth transceiver is used to receive commands from the patient's remote controller 3, such as selecting a stimulation prescription, setting the stimulation intensity, and turning on / off the stimulation, etc.

[0062] The present application uses a high-integration multi-functional application-specific integrated circuit chip to realize an ultra-small implantable stimulator design with a volume close to 4 millimeters. The implant stimulator 1 contains 8 or more independent current pulse stimulation channels, uses two at least 4-channel electrode connectors 118 to connect to two stimulation electrodes 13 containing at least 4 stimulation contacts, a first rechargeable battery 114, and a first coil 12 that 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 at the best implant site in the human head according to the treatment needs, providing electrical stimulation to various parts of the brain nerves, such as the subthalamic nucleus, the medial part of the globus pallidus, the hippocampus, etc., to achieve the treatment of Parkinson's disease, epilepsy, and depression, etc.

[0063] Figure 7 (a) is an internal assembly diagram of the metal shell in the first embodiment of the present application, Figure 7 (b) is an internal assembly diagram of the circuit mainboard in the metal shell in the first embodiment of the present application.

[0064] Please refer to Figure 3b , Figure 7 (a) and Figure 7(b), the metal shell 111 includes a first shell 1111 and a second shell 1112 matched connection, in the first embodiment, the first shell 1111 and the second shell 1112 are sequentially provided with pressure sensitive adhesive sheet 117, frame 115, the first rechargeable battery 114, rubber gasket 113 and circuit board 112, the frame 115 and the circuit board 112 are matched connection. Further, the side of the circuit board 112 is vertically connected to set up PCB mounting plate 1121, used to connect the pin of the feedthrough connecting piece 15 in the shell, the frame 115 is divided into first space 1151 and second space 1152, the first space 1151 is placed in the first rechargeable battery 114, the first rechargeable battery 114 can be provided in the form of cuboid, the end side of the second space 1152 is open end, matched with the installation feedthrough connecting piece 15, the second space 1152 is provided with protrusion 1154 along the side wall of both sides, the protrusion 1154 is provided with slot 1155, the both ends of the PCB mounting plate 1121 are inserted into the slot 1155 for fixation, the pin of the feedthrough connecting piece 15 placed in the end side of the second space 1152 is connected with the mounting plate 1121, the protective solder strip 116 is arranged on the periphery of the frame 115 and is fixed by contacting with the feedthrough connecting piece 15 on the end side of the second space 1152. Correspondingly, the second shell 1112 is also provided with an opening for placing the feedthrough connecting piece 15. In this embodiment, the ASIC chip, the first microprocessor, the first Bluetooth transceiver and the inertial measurement processor are arranged on the same side of the circuit board 112, and the first rechargeable battery 114 is arranged on the other side of the circuit board 112, so as to minimize the space height and meet the requirement of not exceeding the skull thickness too much. The design is compact, so that the craniotomy size is about 25*25mm, and a smaller incision for brain pacemaker implantation surgery is realized. The thickness of the metal shell 111 can be controlled to about 6mm. A plurality of fixed columns 1153 with screw holes are arranged on the side of the first space 1151 of the frame 115, and corresponding first through holes 1122 are arranged on the circuit board 112. After the screw is passed through the first through hole 1122 and fixed in the screw hole of the fixed column 1153, the circuit board 112 is fixed on the frame 115, and the first rechargeable battery 112 is limited in the first space 1151.

[0065] Figure 8 (a) is the internal assembly drawing of the metal shell in the second embodiment of the application, Figure 8 (b) is the internal assembly drawing of the metal shell in the second embodiment of the application, Figure 9 (a)- Figure 9 (d) is respectively the top view, side view, front view and perspective view of the circuit board in the second embodiment of the application.

[0066] 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 to surround the first rechargeable battery 114, and specifically includes a first side 1123, a second side 1124 and a third side 1125, the first side 1123 is connected with the pin of the feedthrough connector 15, various components are arranged on the third side 1125, a second through hole 1126 is arranged on the second side 1124, and the protruding positive / negative electrode 1141 of the first rechargeable battery 114 is inserted into the second through hole 1126. The structure makes the volume of the implant stimulator 1 smaller, and ensures that the total thickness of the implant stimulator 1 meets the requirements of transcranial installation even if the thickness of the battery is close to 5mm. Other structures are similar to those of the first embodiment.

[0067] Figure 10 (a), Figure 10 (b), Figure 10 (c), Figure 10 (d) are respectively a side view, a top view, a perspective view and a front view of the implant mounting bracket base plate in the first embodiment of the present application; Figure 11 (a), Figure 11 (b), Figure 11 (c), Figure 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 application.

[0068] Please refer to Figure 10 (a)- Figure 11 (d), in the first embodiment, the implant stimulator 1 further includes a mounting bracket 6, the mounting bracket 6 includes a base plate 61, a cover plate 64 and a screw 63, the edges of the base plate 61 and the cover plate 64 are provided with hanging ears, and screw holes are arranged on the hanging ears, specifically, a plurality of first hanging ears 62 are formed on the edge of the base plate 61, preferably, the number of the first hanging ears 62 is three, which are arranged outside the two long edges of the base plate 61, and a first screw hole 621 is arranged in each first hanging ear 62; the cover plate 64 is matched and buckled on the base plate 61, a plurality of second hanging ears 65 are formed on the edge of the cover plate 64, preferably, the number of the second hanging ears 65 is three, which are arranged outside the two long edges of the cover plate 64, and a second screw hole 651 is arranged in each second hanging ear 65. After installation, the second hanging ears 65 and the first hanging ears 62 are arranged staggered, 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, and the other side of the mounting bracket 6 includes two second hanging ears 65 and a first hanging ear 62 arranged between the two second hanging ears 65. The screw 63 is used to fix the base plate 61 and the cover plate 64 to the edge of the opening of the skull 5.

[0069] Figure 12 (a) is a schematic view of installing the base plate of the bracket on the head in the first embodiment of the present application, Figure 12 (b),Figure 12 (c) is a schematic view of the process of inserting the implant stimulator between the skull and the scalp and placing the implant body into the base plate in the first embodiment of the present application, Figure 12 (d) is a schematic view of the process of covering the base plate with the cover plate in the first embodiment of the present application.

[0070] When implanting the implant stimulator 1 into the skull, the implant stimulator 1 is installed in the skull 5 through the mounting bracket 6 in the following process:

[0071] Please refer to Figure 12 (a), first, the base plate 61 is installed on the skull 5 through the first screw hole 621 by the screw 63, then, please refer to Figure 12 (b) and Figure 12 (c), the implant body 11 is placed on the base plate 61, the first coil 12 is placed between the scalp 8 and the skull 5, as shown in Figure 13 (c), the thin and flexible first coil 12 arranged outside the implant body 11 can be directly placed between the skull 5 and the scalp 8, which is convenient for installation, saves the skull opening area, and also plays a role in fixing the implant body 11 installed on the skull; then, please refer to Figure 12 (d), cover the cover plate 64, which covers the top of the implant body 11, so that the implant body 11 is enclosed in the cavity formed by the base plate 61 and the cover plate 64, and the cover plate 64 is installed on the skull 5 through the second screw hole 651 by the screw 63. The installation of the mounting bracket 6 is completed as shown in Figure 13 (a) and Figure 13 (b). The surface of the implant body 11 after installing the cover plate 64 is roughly flush with the surface at the first coil 12.

[0072] The mounting bracket 6 including the base plate 61 and the cover plate 64 is used as the fixing device of the implant stimulator 1, which is convenient for surgery and can prevent possible damage to the implant stimulator 1 when the skull hits hard objects.

[0073] 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 is not more than 4 mm. The skull of a human is generally 6-10 mm, and the skull of Chinese people is relatively thin, being 6-8 mm. Therefore, the implant stimulator 1 can be safely fixed on the skull 5 and placed on the cerebral dura mater 9, and the following advantages are achieved: (1) The surgery is facilitated, the surgical trauma is reduced, the inconvenience and risk of the electrode extension line are eliminated, adverse events such as infection and electrode wire breakage that are prone to occur in clinical treatment are overcome, and the treatment effect is improved. (2) Another advantage of the transcranial implantation of the brain pacemaker is that the tunneling and wire threading steps and time of the clinician during implantation are reduced, and the risk of the surgery is also reduced. Because there are complex structures such as arteries, veins, and vagus nerves near the head and neck of the patient, the risk of electrode wire threading through the tunnel is great. (3) Another advantage is that the replacement and removal surgery of the implant stimulator 1 is greatly simplified. Because the doctor only needs to remove the implant stimulator 1 on the skull, the risk of removing the electrode extension wire is reduced. Because the long-term implanted wire is easily connected with the surrounding connective tissue in the neck of the patient, the doctor may need to separate it before removing the stimulating electrode, which has a high risk of surgery and causes great trauma to the patient.

[0074] Figure 14 (a) is a schematic view of the overall structure of the implant stimulator in the third embodiment of the present application, Figure 14 (b) is a schematic view of the implant stimulator in the third embodiment of the present application.

[0075] Please refer to Figure 14 (a) and Figure 14 (b), in the third embodiment, a plurality of first fixed hanging plates 7 are arranged on the first shell 1111. Unlike the first and second embodiments, the mounting bracket 6 is not required in this embodiment, and the structure is simplified. Specifically, one first fixed hanging plate 7 is arranged on each of the three sides of the first shell 1111, and a third screw hole 71 is arranged on each first fixed hanging plate 7. The implant stimulator 1 is fixed on the skull 5 by screwing the screw 63 through the third screw hole 71, and the first fixed hanging plate 7 can be fixed on the first shell 1111 by welding.

[0076] Figure 15 (a) is a schematic view of the overall structure of the implant stimulator in the fourth embodiment of the present application, Figure 15 (b) is a schematic view of the implant stimulator in the fourth embodiment of the present application. Figure 16 (a) is a schematic view of the overall structure of the implant stimulator in the fourth embodiment of the present application, Figure 16 (b) is a schematic view of the overall structure of the implant stimulator in the fourth embodiment of the present application.

[0077] 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, avoid mutual interference, the first coil 12 and the electrode connector 118 are arranged on both sides of the metal shell 111, the electrode connector 118 is encapsulated with epoxy or polyurethane (PU) and then connected with the current pulse output channel of the current pulse generator through the pins of the feedthrough connecting piece 151, the output stimulation signal, the number of pins of the feedthrough connecting piece 151 is 8; the first coil 12 is encapsulated with flexible materials such as silicone or polyurethane (PU) and then connected with the charging module, data communication module and first Bluetooth transceiver on the circuit mainboard 112 through the pins of the feedthrough connecting piece 152, further, as in the first embodiment, the protective sleeve 121 is provided with a Bluetooth communication assembly, the Bluetooth communication assembly includes a Bluetooth chip antenna 122 and a ceramic circuit board 123 carrying the Bluetooth chip antenna 122, in other embodiments, the Bluetooth communication assembly can also be a wire antenna wound in a predetermined shape or a predetermined length, the Bluetooth communication assembly is encapsulated with epoxy or other insulating materials and then encapsulated with flexible materials such as silicone or polyurethane (PU) together with the first coil 12, the output end of the first coil 12 is connected with the charging module and data communication module on the circuit mainboard 112 through the pins of the feedthrough connecting piece 152, the output end of the Bluetooth communication assembly is connected with the first Bluetooth transceiver of the circuit mainboard 112 through the pins of the feedthrough connecting piece 152, the number of pins of the feedthrough connecting piece 152 is 4, of which 2 are connected with the output end of the first coil 12 and the other 2 are connected with the output end of the Bluetooth communication assembly.

[0078] The electrode connector 118 comprises a connecting socket 1181 and a connector housing 1186 arranged outside the connecting socket 1181, the connector housing 1186 is preferably formed by epoxy resin encapsulation, the connecting socket 1181 comprises a locking piece 1181a and a ring-shaped electrode contact 1182, a fourth through hole 1187 is arranged on the front wall of the connector housing 1186, the fourth through hole 1187 is used for inserting the stimulating electrode 13 into the connecting socket 1181, the locking piece 1181a and the electrode contact 1182 are arranged in the connector housing 1186, the ring-shaped electrode contact 1182 is composed of a plurality of metal rings and metal spring rings arranged in the metal rings, an insulating ring is arranged between two adjacent metal rings, fifth through holes 1188 are arranged on the upper and lower surfaces of the connector housing 1186, the locking piece 1181a has a fourth screw hole 1189, the fourth screw hole 1189 corresponds to the position of the fifth through hole 1188, the stimulating electrode 13 is fastened in the connecting socket 1181 after the screw 1183 is screwed into the fifth through hole 1188 and the fourth screw hole 1189, the fifth through hole 1188 is inserted into the sealing piece 1184 for sealing, further, the metal rings and the insulating rings are adhesively fixed, the end of the locking piece 1181a is provided with an electrode protection sleeve 1185, the electrode protection sleeve 1185 can protect the stimulating electrode 13, the materials of the sealing piece 1184 and the electrode protection sleeve 1185 are preferably silica gel, the electrode protection sleeve 1185 and the locking piece 1181a can be preliminarily fixed by silica gel, and then encapsulated and fixed by epoxy resin or polyurethane (PU). Further, the electrode connector 118 can be directly adhesively fixed on the side wall of the metal shell 111, or a fixing block 1115 is arranged on the side wall of the metal shell 111 connected with the electrode connector 118, and the electrode connector 118 is connected to the side wall of the metal shell 111 through the fixing block 1115 when encapsulated by epoxy resin or polyurethane (PU).

[0079] The implant stimulator 1 provided by the embodiment more reasonably arranges electronic elements and circuit wiring, makes the output signal of the implant stimulator 1 more effective, and increases the manufacturability of the structure. When assembling the product, the volume is ultra-small, and the process difficulty index increases. When designing, the manufacturability and testability of the product are considered, which is a prerequisite for ensuring the reliability of the product.

[0080] Please continue to see Figure 15(b), in the fourth embodiment, the metal shell 111 comprises a first shell 1111 and a second shell 1112 which are matchedly connected, the second shell 1112 is a bottom plate, the second shell 1112 is provided with a convex strip 1114, the first rechargeable battery 114 is placed in the range surrounded by the convex strip 1114, the contact part of the second shell 1112, the first rechargeable battery 114 and the circuit main plate 112 is provided with an insulating material for electrical isolation, such as: the convex strip 1114 and the first rechargeable battery 114 are inlaid with an electrical insulating material. The circuit main plate 112 is arranged on the first rechargeable battery 114, the first shell 1111 is a box body which is buckled on the second shell 1112, the side wall of the first shell 1111 which is connected with the first coil 12 and the electrode connector 118 is provided with a third through hole 1113 which is matched with the feedthrough connecting piece 151, 152, the two side feedthrough connecting pieces 151, 152 are installed in the corresponding third through hole 1113, the other two side walls of the first shell 1111 are provided with the second fixed hanging plate 10 which is fixedly installed on the skull 5 through the second fixed hanging plate 10.

[0081] Please refer to Figure 16 (a) and Figure 16 (b), the implanted stimulator 1 disclosed in the embodiment is implanted on the skull 5 in a manner that the skull 5 is not penetrated. The structure requires that the metal shell 111 of the implanted body 11 increases in strength to withstand the consequences caused by the implanted body 11 protruding from the scalp, so the thickness of the metal shell 111 is increased, the thickness of the implanted stimulator 1 is generally between 0.2-0.3mm, the thickness of the lower shell second shell 1112 of the metal shell 111 in the embodiment is 0.4-0.6mm, the periphery is increased to 0.75mm, the thickness of the first shell 1111 is increased to 0.5mm, so as to ensure the strength requirement of impact. Therefore, when the implanted stimulator 1 provided in the embodiment is implanted in the human body, the implanted body 11 is directly implanted on the skull, the skull does not need to be penetrated, and the first coil 12 and the electrode connector 118 are separately arranged on the two sides of the metal shell 111, which is more conducive to the transmission effectiveness and accuracy of the electronic signal.

[0082] Figure 17 It is a structural schematic diagram of the multifunctional head crown in the embodiment of the application; Figure 18 It is a circuit schematic diagram of the multifunctional head crown in the embodiment of the application.

[0083] The present application utilizes the features of the head installation and the first coil 12 of the implanted stimulator 1 to equip the system with an important multi-functional head crown 2, which aims at: 1) achieving high-efficiency charging and high-reliability close-range bidirectional data communication; 2) the design of the multi-functional head crown aims at close and comfortable cooperation with the head when worn by the patient, and does not require additional auxiliary fixing devices such as bandages when working with the implanted stimulator 1, and does not affect the free movement of the patient; 3) utilizing the nerve signal and motion signal detection functions of the implanted stimulator 1, through close-range bidirectional data communication, a clinical data acquisition platform is provided for the patient in a real-time stimulation and free movement environment; 4) utilizing the nerve signal and motion signal detection functions of the implanted stimulator 1, through close-range bidirectional data communication, the recording, processing and analysis of feedback signals are facilitated, and the closed-loop control function of brain stimulation is realized in a working environment that does not affect the power consumption of the implanted battery.

[0084] Please refer to Figure 17 , a second coil 21, a controller 22 and a second rechargeable battery 23 are arranged on the multi-functional head crown 2, the controller 22 and the second rechargeable battery 23 are connected through a flexible cable 24, the controller 22 and the second coil 21 are connected through a flexible cable 24, respectively, the multi-functional head crown 2 is a hat that fits the size of the patient's head, and the hat can be designed in multiple styles, which is not particularly limited by the present application. In the wearing state, the second coil 21 covers the first coil 12, and the size of the second coil 21 and the design of the controller 22 path should ensure that there is a proper movement allowance in the position of the head crown wearing. The second coil 21 is a flat coil spirally wound by twisting a plurality of insulated copper wires, the periphery of the second coil 21 is encapsulated by injection molding of silicone or other flexible materials, and is sewn in a proper position in the fabric of the multi-functional head crown 2, the controller 22 is a thin rigid-flexible circuit board encapsulated by epoxy resin or other insulating materials, and is sewn in the fabric inside the edge of one side of the multi-functional head crown 2, and the second rechargeable battery 23 is sewn in the edge of the other side of the head crown. The second rechargeable battery 23 is preferably a rechargeable lithium battery. The capacity of the second rechargeable battery 23 ensures that the built-in first rechargeable battery 114 of the implanted stimulator 1 can be fully charged more than twice, or can work continuously for more than 12 hours in a closed-loop stimulation mode. The charging of the second rechargeable battery 23 can be realized by a charging module circuit through a USB or a special interface. The total weight of the multi-functional head crown 2 including the second rechargeable battery 23 is not more than 250 grams, so that the patient does not feel the weight when wearing the head crown.

[0085] Please refer to Figure 18The controller 22 comprises a second microprocessor, a second Bluetooth transceiver, a second power management module and a coil driving module. The second microprocessor comprises a signal processing module, a stimulation adjustment processing module and a charging control function module, which are respectively used for processing and analyzing the feedback signals of the implanted stimulator, adjusting the stimulation parameters according to the feedback signals and managing the charging process of the implanted body by the multifunctional crown. The coil driving module comprises a coil driving circuit, a radio frequency signal transceiving circuit and a coil induction charging control interface circuit. The second power management module comprises a second rechargeable battery charging circuit, a charging input interface, a battery protection circuit and a voltage adjustment circuit. The voltage adjustment circuit is responsible for providing a controllable driving voltage for the coil driving circuit and an 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. The second Bluetooth transceiver provides a Bluetooth communication channel for the multifunctional crown 2. The signal processing module is used for processing the feedback signals of the implanted stimulator and extracting useful information. The stimulation adjustment processing module adjusts the stimulation parameters of the implanted body according to the feedback signals. Further, the coil driving module is provided with a safety support circuit for ensuring the radio frequency charging of the implanted stimulator. In order to realize long-term wearing without affecting the patient's free activity, the design index of the coil driving module is high-efficiency power output, and the surface temperature rise of the multifunctional crown 2 is maintained within a safe range. Further, the controller is provided with a radio frequency signal strength detection circuit for judging and reminding whether the position of the multifunctional crown is deviated.

[0086] Therefore, the multifunctional crown 2 realizes the following functions: 1) serving as a charger for the implanted stimulator 1: wirelessly charging the first rechargeable battery 114 in the implanted stimulator 1 through coil coupling, 2) a communication hub: performing short-distance high-speed radio frequency data communication with the implanted stimulator 1 through coil coupling, receiving feedback data of the implanted stimulator 1 and sending control commands. At the same time, the multifunctional crown 2 communicates with the programmer 4 for doctors and a remote controller through a Bluetooth channel. The programmer 4 is provided with a surgery mode, allowing direct or indirect data exchange between the implanted stimulator 1 and the multifunctional crown 2 or the patient's remote controller during the patient's surgery recovery stage. 3) a data processing and control center: recording the feedback data of the implanted stimulator 1, processing and analyzing the feedback data in a closed-loop mode, extracting information related to treatment and deciding real-time adjustment of the stimulation parameters.

[0087] Figure 19 The figure is a self-control mode diagram of the brain nerve electric stimulation system in the embodiment of the present application. Figure 20 The figure is a closed-loop mode diagram of the brain nerve electric stimulation system in the embodiment of the present application.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] In closed-loop system mode, the crown can simultaneously charge or stop charging the implanted stimulator battery according to remote control commands.

[0093] 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.

[0094] Although the present application has been disclosed in its preferred embodiments with reference to the drawings, it will be apparent to those skilled in the art that modifications and improvements can be made without departing from the spirit and scope of the application, and it is intended to cover in the claims any such modifications and improvements that fall within the scope of the application.

Claims

1. An implantable stimulator, characterized in that, The implant 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 by a non-metallic material. The first coil is disposed outside the metal shell. A 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 serves 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 manner with a cable and injected and encapsulated in a biocompatible flexible material with a thickness of less than 3 mm, and is encapsulated with the metal shell in the same 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 can be directly placed between the cerebral cortex and the skull without the need for skull cutting and opening, and plays the role of fixing the main body of the implant; the implant stimulator is used in conjunction with a multifunctional crown, which includes a second coil. The second coil is sewn into a crown fabric suitable for the patient to wear. When the patient wears the crown, the second coil can charge the first power supply of the implant stimulator through inductive coupling with the first coil in the implant stimulator and perform radio frequency data communication as needed.

2. The implantable stimulator as described in claim 1, characterized in that, The circuit board is equipped with 2n independent current pulse generators, forming 2n independently controllable current pulse stimulation channels. The electrode connector is equipped with 2n annular electrode contacts. 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 feedthrough connector. The electrode connector forms 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 implantable stimulator as described in claim 1, characterized in that, The conductor of the first coil is a cable made of multiple strands of pure gold wire twisted together.

4. The implantable stimulator as described in claim 3, characterized in that, The protective sleeve of the first coil also contains a Bluetooth communication component, which is a Bluetooth chip antenna and a ceramic circuit board assembly carrying the Bluetooth chip antenna, or the Bluetooth communication component is a wire antenna wound in a predetermined shape or length. The Bluetooth communication component is encapsulated with insulating material and then encapsulated together with the first coil with the flexible material, and is connected to the first Bluetooth transceiver of the circuit board through the pins of the feedthrough connector.

5. The implantable stimulator as described in claim 4, characterized in that, The first coil and the electrode connector are located on the same side of the metal housing. The electrode connector and the protective sleeve of the first coil are integrally formed and fixed to the side wall of the metal housing. The top surface of the electrode connector is fixedly connected to the protective sleeve of the first coil. The output end of the first coil is connected to the charging module and data communication module on the circuit board through the pin of the feedthrough connector.

6. The implantable stimulator as described in claim 4, characterized in that, The first coil and the electrode connector are respectively located on both sides of the metal housing. The electrode connector is fixed to one side wall of the metal housing, and the protective sleeve of the first coil is fixed to the other side wall of the metal housing. When the implant stimulator is implanted into the human body, the implant body is directly implanted into the skull without needing to penetrate the skull.

7. The implantable stimulator as described in claim 6, characterized in that, The electrode connector includes a connection socket and a connector housing disposed outside the connection socket. The connection socket includes a locking member and annular electrode contacts. The locking member is used to fasten the stimulation electrode. The annular electrode contacts are composed of multiple metal rings and metal spring coils located inside the metal rings. An insulating ring is provided between two adjacent metal rings. An electrode protective sleeve is provided at the end of the locking member.

8. The implantable stimulator as described in claim 6, characterized in that, The electrode connector is directly bonded to the side wall of the metal housing, or a fixing block is provided on the side wall of the metal housing where the electrode connector is connected. When the electrode connector is encapsulated with epoxy resin or polyurethane (PU), it is connected to the side wall of the metal housing through the fixing block.

9. The implantable stimulator as described in claim 6, characterized in that, The first power source is a first rechargeable battery. The metal housing includes a first housing and a second housing that are matched and connected. The second housing is a base plate with a raised strip on it. The first rechargeable battery is placed within the area enclosed by the raised strip. The circuit board is mounted on the first rechargeable battery. The contact points between the base plate, the first rechargeable battery, and the circuit board are provided with insulating material for electrical isolation. The first housing is a box that is fastened to the second housing. The side wall of the second housing that connects to the first coil and the electrode connector has through holes that match the feedthrough connectors. The feedthrough connectors on both sides are installed in the corresponding through holes. The other two side walls of the second housing are provided with second fixing plates.

10. The implantable stimulator as claimed in claim 1, characterized in that, The first power source is a first rechargeable battery. The circuit board is equipped with an ASIC chip, a first microprocessor, a first Bluetooth transceiver, and an inertial measurement processor. 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 interfaced with the first microprocessor. 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.

11. The implantable stimulator as described in claim 10, characterized in that, The first microprocessor sends a data packet containing the stimulation mode and stimulation amplitude to the stimulation unit control circuit of the current pulse generator via an instruction. 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.

12. The implantable stimulator as described in claim 11, characterized in that, The stimulation unit control circuit 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 electrodes through a level shifter, thereby controlling the pulse width, pulse frequency, output polarity and output mode of the current stimulation pulse via the input control signal.

13. The implantable stimulator as described in claim 10, characterized in that, The number of stimulation electrodes is two, which can be used to stimulate the brain regions on both sides respectively. Each electrode contains at least four stimulation contacts. The neural signal detection module uses any two or more stimulation electrode contacts as a measurement electrode to detect the potential of the neural region. The measured signal is stored in the implant's internal memory as needed or fed back to the external device through the bidirectional radio frequency data communication module and the first coil.

14. The implantable stimulator as described in claim 10, characterized in that, The inertial measurement processor detects the patient's movement and heart rate changes, and feeds back the measured signals to the external device through the bidirectional radio frequency data communication module and the first coil.

15. The implantable stimulator as described in claim 10, characterized in that, The ASIC chip, the microprocessor, the first Bluetooth transceiver, and the inertial measurement processor are arranged on the same side of the circuit board, and the first rechargeable battery is placed on the other side of the circuit board.

16. The implantable stimulator as described in claim 10, characterized in that, The metal housing includes a first housing and a second housing that are matched and connected. A pressure-sensitive film, a frame, a first rechargeable battery, a rubber pad and the circuit board are sequentially arranged between the first housing and the second housing. The frame and the circuit board are matched and connected. The first rechargeable battery is placed inside the frame and a protective solder strip is arranged around the frame.

17. The implantable stimulator as described in claim 16, characterized in that, A PCB mounting plate is vertically connected to the side of the circuit board. The frame is divided into a first space and a second space. The first rechargeable battery is placed in the first space. The end of the second space is an open end, which is matched and installed with a feedthrough connector. The second space has protrusions along its two side walls, and slots are provided on the protrusions. The two ends of the PCB mounting plate are inserted into the slots for fixation. The pins of the feedthrough connector placed on the end of the second space are connected to the mounting plate.

18. The implantable stimulator as claimed in claim 10, characterized in that, The metal housing includes a first housing and a second housing that are matched and connected. The first rechargeable battery and the circuit board are placed between the first housing and the second housing. The circuit board is a rigid-flexible circuit board that is bent and surrounds the first rechargeable battery.

19. The implantable stimulator as claimed in claim 1, characterized in that, It also includes a mounting bracket, which includes a chassis, a cover plate, and screws. The edges of the chassis and the cover plate are provided with lugs, and the lugs are provided with screw holes. The screws can fix the chassis to the edge of the skull opening through the screw holes. The implant body is placed on the chassis, and the cover plate covers the top of the implant body. The screws can fix the cover plate to the edge of the skull opening through the screw holes on the cover plate. After the cover plate is installed, the surface of the implant body is approximately flush with the surface at the first coil.

20. The implantable stimulator as described in claim 16 or 17, characterized in that, The first housing is provided with a plurality of first fixing plates, and the first fixing plates are provided with third screw holes.

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