WO2023024587A1

WO2023024587A1 - Hypoglossal nerve stimulation device

Info

Publication number: WO2023024587A1
Application number: PCT/CN2022/092695
Authority: WO
Inventors: 萨万·穆罕穆德; 夏芬
Original assignee: 西湖大学
Priority date: 2021-08-23
Filing date: 2022-05-13
Publication date: 2023-03-02
Also published as: CN113856047A; CN113856047B

Abstract

The present application relates to the field of medical instruments, and discloses a hypoglossal nerve stimulation device, comprising an in-vivo device and an in-vitro device. The in-vivo device is mounted at a distal end of a hypoglossal nerve, and comprises an integrated chip, a stimulation electrode, and a flexible coil; the integrated chip is connected to the stimulation electrode and the flexible coil, respectively; the flexible coil is used for receiving energy and stimulation information sent by the in-vitro device; the integrated chip is used for generating a stimulation pulse according to the received energy and stimulation information; and the stimulation electrode is used for transmitting the stimulation pulse to the hypoglossal nerve. The in-vitro device is mounted on the body surface above the in-vivo device, and comprises a coil and a controller; the controller is connected to the coil, and is used for generating energy and stimulation information; and the coil is used for transmitting the energy and the stimulation information to the in-vivo device. The hypoglossal nerve stimulation device is divided into the in-vivo device and the in-vitro device which use a magnetic induction link formed by the in-vivo coil and the in-vitro coil to perform communication and energy transmission, the size of the in-vivo device is reduced, and practicability and safety are improved.

Description

hypoglossal nerve stimulation device

technical field

The embodiment of the present application relates to the field of medical devices, in particular to a hypoglossal nerve stimulation device.

Background technique

Normally, air flows smoothly through the airways from the mouth and nose into the lungs. Blockage or narrowing of the airways during breathing can cause apnea. Obstructive sleep apnea (OSA) is the involuntary short-term cessation of breathing during sleep when one should be breathing normally. Typical clinical symptoms include loud snoring, drowsiness, insomnia, and brain hypoxia at night. Without proper diagnosis and treatment, it can increase the risk of heart disease, diabetes, stroke, and even life-threatening in patients with severe OSA. Measuring the apnea-hypopnea index (AHI) can determine the severity of the patient's apnea. Adult AHI is normal when AHI is less than 5, mild OSA is 5≤AHI<15, moderate OSA is 15≤AHI<30, and severe OSA is AHI≥30. Although continuous positive airway pressure (CPAP) has a good therapeutic effect on OSA patients, it is necessary for patients to wear a mask during sleep, and only 50% of patients are willing to wear CPAP during sleep. Patients' treatment has only 50% compliance and prevalence. Researchers are currently working on developing innovative alternatives. Improve adherence to OSA treatment. Hypoglossal nerve stimulation (HGNS) offers a promising solution as an emerging method that stimulates the hypoglossal nerve during inhalation, causing the hypoglossal muscles to contract, thereby widening the patient's airway . Install HGNS in the patient's body, detect whether the patient is in apnea state, stimulate the hypoglossal nerve, open the breathing channel, and help the patient to breathe normally with a success rate of up to 76%, and can make the patient's apnea-hypopnea index (AHI) less than 5.

The current hypoglossal nerve stimulation system is bulky, and the system mainly consists of three implantable components: a breathing sensor, a stimulation generator, and a stimulation electrode. The respiration sensor detects breathing patterns by sensing the bioimpedance of chest wall motion and transmits the information to the electrical stimulation generator via lead wires. The electrical stimulation generator then provides electrical stimulation pulses to the stimulating electrode, which transmits the stimulating signal to the hypoglossal nerve. Patients with interrupted breathing who receive electrical stimulation therapy undergo three incisional procedures. The first incision was made at the inferior border of the patient's right submandibular gland, distal to the patient's hypoglossal nerve, for the placement of stimulating electrodes. Stimulating the distal end of the hypoglossal nerve stretches the tongue forward, keeping the airway open. The second incision is made parallel to the ribs, midway between the third and fourth ribs. This incision is used to place the respiratory sensor, which detects the respiratory state by sensing the bioimpedance of the chest wall motion to determine whether the patient is exhaling or inhaling, and transmits this information to the stimulus generator. The stimulation generator receives the information detected by the respiration sensor and provides stimulation signals to the stimulation electrodes. The stimulation generator is equivalent to a central system, which is the most core device in the implantable hypoglossal nerve stimulation system. The opening for the stimulus generator is 2-4 cm below the right clavicle. All three implant components need to be connected by wires implanted in the body.

However, for patients, in order to place the hypoglossal nerve stimulation system, multiple surgeries or multi-incision surgeries are required to implant the device. There are many surgical sites and large wounds, and postoperative complications are prone to occur, such as pain and inflammation. etc. The three main components are connected by wires, which are greatly affected by physical activities and are prone to malfunction, posing safety hazards. The service life of the power supply battery of the hypoglossal nerve stimulation system is limited, and reoperation is required after the battery is exhausted. Carrying out the replacement of battery will bring secondary trauma to the patient.

Contents of the invention

The main purpose of the embodiments of the present application is to propose a hypoglossal nerve stimulation device, which can be used in the treatment of respiratory interruption, and aims to reduce the volume of the hypoglossal nerve stimulation device implanted in the user's body, reduce the number of operations and the wound area of the patient, and avoid implantation. The potential safety hazards caused by the wires connected to the equipment and the secondary trauma caused to the user when the battery is powered by the internal battery are used to improve the reliability and practicability of the hypoglossal nerve stimulation device.

In order to achieve the above purpose, an embodiment of the present application provides a hypoglossal nerve stimulation device, including: an internal device and an external device; the internal device is installed on the distal end of the hypoglossal nerve, and the internal device includes an integrated chip, a stimulating electrode, and a flexible coil. The integrated chip is connected to the stimulating electrode and the flexible coil respectively, the flexible coil is used to receive the energy and stimulation information sent by the external device, the integrated chip is used to generate the stimulation pulse according to the received energy and stimulation information, and the stimulation electrode is used to transmit the stimulation pulse to the Hypoglossal nerve; the extracorporeal device is installed on the body surface above the internal device, the extracorporeal device includes a coil and a controller, the controller is connected to the coil, the controller is used to generate energy and stimulation information, and the flexible coil is used to transmit energy and stimulation information into the body device.

The hypoglossal nerve stimulation device provided in the embodiment of the present application divides the hypoglossal nerve stimulation device into an internal device and an external device. The flexible coil contained in the internal device and the coil contained in the external device form a magnetic induction link. The internal device and the external device pass through magnetic induction. The link performs energy transmission and data exchange. The external device sends energy and stimulation information to the internal device. After receiving the energy transmitted by the external device, the internal device activates the internal circuit and enters the working state. The user's obstructive apnea can be treated by stimulating the electrodes to the hypoglossal nerve; by splitting the hypoglossal nerve stimulation device into a highly integrated internal device and an external device, the volume of the device that needs to be implanted in the user's body is greatly reduced , reducing the number of surgeries required by users and the area of surgical wounds, and reducing the pain caused by surgeries; the communication and energy transmission between internal devices and external devices is realized by using the magnetic induction link composed of coils, and no implantation is required. The wires and power supply in the user's body avoid damage to the user due to device failure or safety hazards that may be caused by the user's body movement, and secondary damage to the user caused by battery replacement, which improves the safety and practicability of the entire device.

Description of drawings

One or more embodiments are exemplified by pictures in the accompanying drawings, and these exemplifications are not intended to limit the embodiments.

Fig. 1 is a structural schematic diagram of a hypoglossal nerve stimulation device in an embodiment of the present invention;

Fig. 2 is a schematic diagram of the installation method of the hypoglossal nerve stimulation device in the body of the embodiment of the present invention;

3 is a schematic structural diagram of the first PCB sub-board of the in vivo device of the hypoglossal nerve stimulation device in an embodiment of the present invention;

Fig. 4 is a schematic structural diagram of the second PCB sub-board of the internal device of the hypoglossal nerve stimulation device in the embodiment of the present invention;

Fig. 5 is a schematic diagram of the circuit structure of the hypoglossal nerve stimulation device in the embodiment of the present invention;

Fig. 6 is a structural schematic diagram of another hypoglossal nerve stimulation device in an embodiment of the present invention.

Detailed ways

It can be seen from the background technology that for the hypoglossal nerve stimulation system currently used for patients, in order to place the hypoglossal nerve stimulation system, it is necessary to undergo multiple surgeries or operations with multiple wounds for device implantation. There are many surgical sites, large wounds, and Postoperative complications are prone to occur, such as pain, inflammation, etc., and the three main components are connected by wires, which are greatly affected by physical activities and are prone to failure, posing safety hazards, and the power supply battery of the hypoglossal nerve stimulation The service life is limited, and after the battery power is exhausted, a new operation is required to replace the battery, which will bring secondary trauma to the patient. Therefore, how to reduce the injury and pain caused to patients during the placement and use of the hypoglossal nerve stimulation device, and how to improve the practicability and safety of the hypoglossal nerve stimulation device is an urgent problem to be solved.

In order to solve the above problems, an embodiment of the present application provides a hypoglossal nerve stimulation device applied to the treatment of respiratory interruption, including: an internal device and an external device; the internal device is installed on the distal end of the hypoglossal nerve, and the internal device includes an integrated chip , stimulating electrodes, flexible coils, the integrated chip is connected to the stimulating electrodes and flexible coils respectively, the flexible coils are used to receive the energy and stimulation information sent by the external device, the integrated chip is used to generate stimulation pulses according to the received energy and stimulation information, and the stimulating electrodes Used to transmit stimulation pulses to the hypoglossal nerve; the extracorporeal device is installed on the body surface above the internal device, the extracorporeal device includes a coil and a controller, the controller is connected to the coil, the controller is used to generate energy and stimulation information, and the coil is used to transfer energy and stimulation information is transmitted to the in vivo device.

The hypoglossal nerve stimulation device provided in the embodiment of the present application divides the hypoglossal nerve stimulation device into an internal device and an external device. The flexible coil contained in the internal device and the coil contained in the external device form a magnetic induction link, and the external device and the internal device pass through magnetic induction. The link performs energy transmission and data exchange. The external device sends energy and stimulation information to the internal device. After receiving the energy transmitted by the external device, the internal device activates the internal circuit to enter the working state, and generates specific stimulation pulses according to the stimulation information transmitted by the external device. , and transmit it to the hypoglossal nerve through the stimulating electrodes to treat the user's obstructive apnea; by splitting the hypoglossal nerve device into a highly integrated internal device and an external device, it greatly reduces the number of devices that need to be implanted in the user's body The volume reduces the number of operations and the area of surgical wounds that users need to perform, and reduces the pain caused by the operation; the communication and energy transmission between the internal device and the external device are realized by using the magnetic induction link formed by the coil, and there is no need to set up an implant The wires and power supply inserted into the user's body avoid damage to the user due to device failure or safety hazards that may be caused by the user's body movement, and secondary damage to the user caused by battery replacement, which improves the safety and practicability of the entire device.

In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the embodiments of the present application will be described in detail below with reference to the accompanying drawings. However, those of ordinary skill in the art can understand that in each embodiment of the application, many technical details are provided for readers to better understand the application. However, even without these technical details and various changes and modifications based on the following embodiments, the technical solutions claimed in this application can also be realized. The division of the following embodiments is for the convenience of description, and should not constitute any limitation to the specific implementation of the present application, and the embodiments can be combined and referred to each other on the premise of no contradiction.

The hypoglossal nerve stimulation device described in this application will be described in detail below in conjunction with specific embodiments. The following content is only implementation details provided for easy understanding, and is not necessary for implementing this solution.

The first aspect of the embodiment of the present invention provides a hypoglossal nerve stimulation device applied to the treatment of respiratory interruption. The overall structural diagram of the hypoglossal nerve stimulation device refers to Figure 1, including:

The internal device 101 is installed on the distal end of the hypoglossal nerve. The internal device includes an integrated chip, a stimulating electrode, and a flexible coil. The integrated chip is connected to the stimulating electrode and the flexible coil, and the flexible coil is used to receive the energy and stimulation sent by the external device. The integrated chip is used to generate stimulation pulses according to the received energy and stimulation information, and the stimulation electrodes are used to transmit the stimulation pulses to the hypoglossal nerve.

Specifically, the hypoglossal nerve stimulation device includes two parts: an internal device and an external device. The internal device is surgically implanted into the distal end of the hypoglossal nerve in the user's body. After the hypoglossal nerve stimulation device starts to work, the internal device receives The energy and stimulation information transmitted by the external device, and then the highly integrated HGNS chip in the internal device enters the working state after receiving the energy transmitted by the external device, demodulates and analyzes the received stimulation information, and generates specific stimulation information according to the stimulation information. The stimulating pulse is transmitted to the hypoglossal nerve through the connected stimulating electrode to realize the treatment of the user's apnea symptoms.

In one example, the internal device is integrated on a flexible PCB, and the flexible PCB is bent into a sleeve shape. The schematic diagram of the installation method of the in-vivo device is shown in Figure 2. The in-vivo device 201, which is highly integrated on a flexible PCB and bent into a sleeve shape, wraps around the distal end of the hypoglossal nerve 202 of the user as much as possible. As the substrate of the internal device, the internal device is highly integrated on the flexible PCB board, which greatly reduces the volume of the internal device and facilitates implantation into the user's body through a small wound; by bending the flexible PCB board integrated with the internal device into The shape of the cuff forms a nerve cuff that can wrap the hypoglossal nerve, so that the integrated in vivo device can be wrapped around the distal end of the hypoglossal nerve as much as possible after being encapsulated with biocompatible flexible materials, and can accurately pass through the stimulating electrodes. Stimulation pulses are sent to the hypoglossal nerve while reducing the possibility of device movement in the body due to activity.

In another example, the flexible PCB is formed by superimposing the first PCB sub-board and the second PCB sub-board; the integrated chip and the stimulating electrode are integrated on the first PCB sub-board of the hypoglossal nerve; On the second PCB sub-board of the lower nerve, the integrated chip is connected to the flexible coil through the coil contact pad on the first PCB sub-board. When wrapping the distal hypoglossal nerve with an internal device, the internal device will have a side close to the hypoglossal nerve and a side relatively far away from the hypoglossal nerve. Communication and energy transmission, the flexible PCB board is made into a composite structure of upper and lower layers, which is formed by superposition of two flexible PCB sub-boards, and the highly integrated HGNS chip and stimulating electrodes are integrated on the first PCB sub-board closer to the hypoglossal nerve. On the board, a schematic structural diagram of a first PCB sub-board in this embodiment is shown in FIG. The

contact pads

304 and 305 of the flexible coil on the flexible PCB sub-board; a schematic structural diagram of a second PCB sub-board in this embodiment is shown in Figure 4, the second PCB sub-board includes a flexible coil 403, and the flexible coil and

Contact pads

401 and 402 to which the HGNS chip is connected. By integrating the flexible coil on the second PCB sub-board that is farther away from the hypoglossal nerve than the first PCB sub-board, and connecting the flexible coil with the HGNS chip through the contact pads on the first PCB sub-board and the second PCB sub-board The first PCB sub-board and the second PCB sub-board are superimposed together, and packaged into a sleeve shape with biocompatible materials, the first PCB sub-board is used as the inner side of the sleeve, and the second PCB sub-board is used as the sleeve The outside of the sleeve wraps around the hypoglossal nerve. While reducing the volume of the internal device as much as possible, ensure that the internal device can accurately interact with the external device for stimulation information and energy transmission, avoid the movement of the internal device due to human body movement, and accurately stimulate the hypoglossal nerve.

External device 102, the external device is installed on the body surface above the internal device, the external device includes a coil and a controller, the controller is connected to the coil, the controller is used to generate energy and stimulation information, and the coil is used to transmit energy and stimulation information to the internal device .

Specifically, the external part of the hypoglossal nerve stimulation device is installed on the body surface above the internal device, for example, hung on the ear by a hook-type bracket, and the main body of the external device is close to the user's cheek or placed on the user's neck On the surface, the coil in the external device can be as close as possible to the top of the internal device, and the coil of the external device and the flexible coil of the internal device form a magnetic induction link for the interaction of energy and stimulation information, and the hypoglossal nerve stimulation device starts to work Finally, the controller of the external device generates stimulation information for controlling the internal device to send stimulation pulses and energy for powering the internal device, and sends the energy and stimulation information to the internal device through the coil connected to the controller.

In one example, the external device further includes a respiration sensor, which is connected to the controller, and the respiration sensor is used to detect the breathing state of the user, and sends an apnea alarm to the controller when the user has apnea; the controller also It is used to send energy and stimulation information to the internal device through the magnetic induction link composed of the coil and the flexible coil after receiving the apnea alarm. By setting a breathing sensor in the external device to sense the user's breathing state, after the apnea device starts working, the breathing sensor starts to detect the user's breathing state in real time to determine whether the user has apnea symptoms. When symptoms of apnea occur, the external device does not send energy and stimulation information to the internal device. The internal device is turned off, and the external device remains in the standby state. Inhalation state or inhalation state, when the user has inhalation apnea, the respiration sensor will generate an apnea warning and send the apnea alarm to the controller. After the controller receives the alarm information from the respiration sensor, it will The pulse parameters of the stimulation pulse send energy and stimulation information to the internal device, and the internal device enters the working state after receiving the energy, demodulates the received stimulation information, and generates a specific stimulation pulse according to the demodulation result, which will be generated through the stimulating electrodes. The stimulation pulses are delivered to the user's hypoglossal nerve.

In addition, in practical applications, the breathing sensor can be separately installed in the external device and connected to the controller, or can be directly integrated in the controller, thereby further reducing the volume of the external device. The specific installation method of the breathing sensor in the extracorporeal device in this embodiment is not limited. By adding a breathing sensor and sending stimulation pulses to the user when the user has apnea, the apnea device is avoided to be kept in the working state, the overall energy consumption of the apnea stimulation device is further reduced, and the charging of the external device is increased. Time interval; by sending stimulation pulses only when the user needs to treat the symptoms of apnea, and not sending stimulation pulses in the rest of the time, it can avoid the user's tolerance to the stimulation pulse due to long-term electrical stimulation, and ensure the safety of the apnea device. long-term effectiveness.

In another example, the in-vivo device further includes: a first discrete capacitor and a second discrete capacitor, the first discrete capacitor forms a resonant circuit with the flexible coil; The flexible coil is also used to transmit the electrical stimulation response to the external device; the external device is also used to receive the electrical stimulation response, adjust the stimulation information sent according to the electrical stimulation response, and form a closed-loop adjustment circuit of the stimulation pulse. For example, a schematic diagram of the circuit structure of a hypoglossal nerve stimulation device is shown in Figure 5. The controller of the external device integrates a power supply, a microcontroller, a modulator, a demodulator, and an amplifier. At the same time, the external device also includes discrete Capacitor C1 and coil L1, the parasitic resistance R1 of the in vitro device, the coil L1 in the in vitro device and the discrete capacitor C1 form a resonant circuit and are connected to the controller. Under the control of the controller, the highly integrated HGNS chip in the in vivo device includes a power supply Processing unit and data communication unit, power processing unit includes rectifier and voltage regulator, data communication unit includes modulator, demodulator, microcontroller, bipolar current pulse generator, amplifier; HGNS chip is connected with transmitting stimulation pulse to tongue The upper and lower stimulating electrodes of the lower nerve are connected, the first discrete capacitor C2 and the resonant circuit formed by the flexible coil L2, the flexible coil L2 is connected with the other two ports of the HGNS chip, and the data communication unit of the HGNS chip also includes a detection The stimulation information module between the stimulation electrodes is composed of an amplifier and a tuner. The modulation information reflects the change of the second discrete capacitance in the body and is transmitted to the external device through the flexible coil in the body.

During the working process of the hypoglossal nerve stimulation device, when the controller in the external device senses that the patient is in a state of apnea, according to the stimulation pulse parameters corresponding to the stimulation pulses to be sent to the hypoglossal nerve, a resonant circuit composed of discrete capacitors and coils is used , to provide energy and send stimulation information to the internal device; the internal device receives the energy from the external device through the resonant circuit formed by the first discrete capacitor and the flexible coil, and then transmits the energy transmitted from the external device to the rectifier and voltage of the power processing unit The regulator is used to supply power to the internal device, and the circuit of the internal device is turned on to enter the working state. After receiving the stimulation information sent by the external device, the data communication unit demodulates the received stimulation information, and the microcontroller demodulates the signal according to the demodulator. As a result, the bipolar current pulse generator is controlled to generate specific stimulation pulses, and the stimulation pulses are transmitted to the hypoglossal nerve through the upper and lower stimulation electrodes to stimulate the hypoglossal nerve. The use of bipolar current stimulation can reduce or eliminate the accumulation of charge in the body between the electrodes, and avoid damage to the body due to overheating of the body.

After the hypoglossal nerve device transmits stimulation pulses to the hypoglossal nerve, the microcontroller in the body device can also detect the user's electrical stimulation response to the pulse, and then the microcontroller controls the modulator to perform communication coding modulation on the detected electrical stimulation response information , adjust the capacitance value of the second discrete capacitor, and transmit the modulated electrical stimulation response information to the external device through the flexible coil. After the external device receives the electrical stimulation response information transmitted by the internal device through the coil, it decodes the electrical stimulation response information through the demodulator, and then the controller adjusts the subsequent electrical stimulation response information to be sent to the Stimulation information in the internal device, and the adjusted stimulation information is sent to the internal device through the modulator and amplifier, and the internal device adjusts the stimulation pulse sent to the hypoglossal nerve according to the received stimulation information. Through the two-way communication of the magnetic induction link between the internal device and the external device and the feedback regulation of the stimulation pulse, a closed-loop regulation circuit of the stimulation pulse is formed between the internal device and the external device, and the stimulation pulse received by the user is avoided. Harm to the user Or due to changes in the user's physical state, the original stimulation pulse can no longer play a good therapeutic effect on the user, and the closed-loop adjustment method is used to further improve the effectiveness and reliability of the apnea treatment of the hypoglossal nerve stimulation device. In addition, the step of closed-loop adjustment of the stimulation pulse according to the electrical stimulation response information can run through the entire use process of the sublingual stimulation device, and can also be selectively turned on, which is not limited in this embodiment.

In another example, the in-vivo device is also used to detect the voltage and resistance between the stimulating electrodes to obtain the electrical stimulation response. After the device in the body sends stimulation pulses to the hypoglossal nerve according to the received energy and stimulation information, the user's response to the stimulation pulses will change in real time, and the electrical characteristics shown are real-time changes in the voltage and resistance between the electrodes. Measure the voltage value and resistance value between the upper and lower stimulating electrodes, so as to obtain the degree of excitement of the user's hypoglossal nerve after the electrical stimulation of the stimulating pulse, and use the voltage value and resistance value between the upper and lower stimulating electrodes Characterize the user's electrical stimulation response information, and transmit it to the external device. After receiving the electrical stimulation response information, the external device demodulates the electrical stimulation response information. When the voltage value and resistance value do not exist in the preset interval, pass The way of feedback regulation is to readjust the stimulation information sent to the internal device, so that the hypoglossal nerve is stimulated by the adjusted stimulation pulse, and the voltage and resistance between the electrodes fall within the preset range. By detecting the voltage value and resistance value between the stimulating electrodes, the response of the user's hypoglossal nerve to the stimulation pulse can be accurately obtained, and reliable user response data can be provided for the subsequent feedback adjustment to further ensure the effectiveness of the stimulation pulse therapy. .

In another example, the in-body device adjusts the capacitance value of the second discrete capacitor through load keying modulation. After the in-body device detects the electrical stimulation response of the user's hypoglossal nerve to the stimulation pulse, it uses the load keying modulation method to adjust the capacitance connection state of the second discrete capacitor through the in-body microcontroller to change the second discrete capacitor. The capacitance value realizes the information encoding of the electrical stimulation response. By using the load keying modulation method, the switch reaction time for controlling the change of the capacitance value is greatly reduced, and the detected user's electrical stimulation response information is transmitted to the external device in time. In practical applications, the C-MOS tube can also be used as the switch of the second discrete capacitor, and the high-efficiency on-off characteristics of the C-MOS tube can be used to replace the new switch that needs to be added. The C-MOS switch is integrated in the internal integrated circuit. The switching state of the C-MOS is controlled by the micro-controller in the body to ensure the capacitance adjustment efficiency and further reduce the volume of the device in the body. This embodiment does not limit the specific selection of the switch for controlling the capacitance of the second discrete capacitor.

In another example, the controller modulates the stimulus information by amplitude shift keying modulation or phase shift keying modulation. The external device of the apnea stimulation device includes a controller integrating a microcontroller, a modulator, a demodulator, and an amplifier. When the apnea stimulation device enters the working state, the impulse stimulation transmitted to the hypoglossal nerve is transmitted as needed. parameter, the microcontroller generates stimulation information sent to the device in the body through the modulator, and the modulation of the stimulation information can be modulated by amplitude shift keying modulation or phase shift keying modulation. The stimulation signal to be sent is modulated, and the modulator When the working mode is set to amplitude shift keying modulation, the simplest stimulation signal modulation can be realized, and the volume of the controller can be reduced as much as possible. When the working mode of the modulator is set to phase shift keying modulation, the lowest The energy loss transmits the generated stimulation signal to the internal device, reduces the overall energy consumption of the external device, and prolongs the charging time of the external device.

In practical applications, the modulation mode used for communication between the internal device and the external device can be selected and changed according to actual conditions or needs, and this embodiment does not limit the specific modulation mode.

In another example, the apnea stimulation device further includes: a remote controller, which communicates with the external device, and the remote controller is used to receive the stimulation parameters set by the user and send the stimulation parameters to the external device; the external device is also used to adjust the stimulation parameters according to the stimulation parameters. Stimulus information. The schematic diagram of the structure of the apnea device including the remote control is shown in Figure 6, including the internal device 601, which is used to send stimulation pulses to the hypoglossal nerve and feedback the user's electrical stimulation response information; the external device 602, which is used to transmit energy to the internal device and stimulation information, adjust the transmitted stimulation information according to the electrical stimulation response of the internal device; the remote controller 603 communicated with the external device, the remote controller includes a micro-control regulator and a communication unit, both of which can also be integrated in the microcontroller , through the micro-control regulator to receive the parameter settings of the stimulation pulse sent to the hypoglossal nerve by the user or the doctor, including parameters such as the intensity and duration of the stimulation pulse, and send the received stimulation parameters to the external device, and the external device according to the received The received stimulation parameters are used to adjust the stimulation information that needs to be sent to the internal device. Through the communication connection between the remote control and the external device, the stimulation pulse sent to the hypoglossal nerve of the user can be adjusted without taking out the internal device, avoiding the need for secondary surgery to stimulate the pulse after the user develops tolerance to the specific pulse The resetting of the apnea device improves the practicality of the apnea device.

In addition, the breathing sensor can also be set in the remote control, and the breathing sensor is no longer set in the external device, and the breathing sensor set in the remote control can be used to detect whether the user has apnea symptoms and breathing status. When the user has an apnea state and is in the apnea state of inhalation, the respiration sensor provides alarm information to the microcontroller. , sending instructions carrying stimulation parameters to the external device, controlling the external device to send energy and stimulation information to the internal device according to the stimulation parameters, and starting to perform specific electrical stimulation on the user. By setting the breathing sensor in the remote control, the volume of the external device located on the body surface is reduced, and the external device is prevented from being in a standby state in real time. The internal device and the external device can be turned off when there is no need to send stimulation pulses. According to Commands from the remote control only send stimulation pulses after a certain point in time, further reducing overall energy consumption.

In addition, after the internal device feeds back the user's electrical stimulation response information to the stimulation pulse to the external device, the external device can also transmit the electrical stimulation response information to the remote control, and the user can set the stimulation parameters by himself according to the electrical stimulation response information displayed on the remote control. For adjustment, the microcontroller of the remote control can also adjust the stimulation parameters according to the mechanism of feedback adjustment, and send the adjusted stimulation parameters to the external device, which is not limited in this embodiment. The stimulation pulse is adjusted by means of closed-loop control to ensure the effectiveness of the stimulation pulse and avoid the stimulation pulse from causing harm to the user.

In practical applications, the breathing sensor can be set in an external device or in a remote controller according to actual needs, and this embodiment does not limit the specific setting manner of the breathing sensor.

In another example, the external device communicates with the remote controller through a data cable, bluetooth or wireless network. The remote controller and the external device can be directly connected through a data cable to realize high-speed and accurate signal transmission and ensure the accuracy of stimulation parameters; they can also be connected by connecting to a wireless network for data transmission, avoiding the need for physical connection. The connection is limited by the connection line; it can also be connected to the external device in the form of Bluetooth pairing, avoiding the inability to accurately and efficiently perform hypoglossal nerve stimulation in the scene where the use of the local area network is limited, and connect the external device and remote control through a variety of possible communication connection methods The device ensures the accuracy and efficiency of data communication between the two, and further guarantees the practicability and reliability of the hypoglossal nerve stimulation device.

In addition, it should be understood that the division of steps in the above methods is only for clarity of description, and may be combined into one step or split into multiple steps during implementation. As long as the same logical relationship is included, all Within the scope of protection of this patent; adding insignificant modifications or introducing insignificant designs to the algorithm or process, but not changing the core design of the algorithm and process are all within the scope of protection of the patent.

Those of ordinary skill in the art can understand that the above-mentioned embodiments are specific embodiments for realizing the present application, and in practical applications, various changes can be made to it in form and details without departing from the spirit and spirit of the present application. scope.

Claims

A hypoglossal nerve stimulation device, characterized in that it includes: an internal device and an external device;

The internal device is installed on the distal end of the hypoglossal nerve. The internal device includes an integrated chip, a stimulating electrode, and a flexible coil. The integrated chip is connected to the stimulating electrode and the flexible coil respectively. The flexible coil is used for receiving energy and stimulation information sent by the external device, the integrated chip is used to generate stimulation pulses according to the received energy and stimulation information, and the stimulation electrodes are used to transmit the stimulation pulses to the tongue lower nerve;

The extracorporeal device is installed on the body surface above the in vivo device, the extracorporeal device includes a coil and a controller, the controller is connected to the coil, and the controller is used to generate the energy and the stimulation information, The coil is used to transmit the energy and the stimulation information to the in vivo device.
The hypoglossal nerve stimulation device according to claim 1, further comprising: a remote controller;

The remote controller is communicatively connected with the external device, the remote controller is used to receive stimulation parameters set by the user, and send the stimulation parameters to the external device;

The extracorporeal device is also configured to adjust the stimulation information according to the stimulation parameters.
The hypoglossal nerve stimulation device according to claim 2, characterized in that, the communication connection between the external device and the remote controller is performed through a data line, bluetooth or wireless network.
The hypoglossal nerve stimulation device according to claim 1, wherein the internal device further comprises: a first discrete capacitor and a second discrete capacitor, the first discrete capacitor is used to form a resonant circuit with the flexible coil ; The second discrete capacitor is used to adjust the capacitance value according to the user's electrical stimulation response to the stimulation pulse, and the flexible coil is also used to transmit the electrical stimulation response to the external device;

The extracorporeal device is also used to receive the electrical stimulation response, adjust the stimulation information sent according to the electrical stimulation response, and form a closed-loop adjustment loop of the stimulation pulse.
The hypoglossal nerve stimulation device according to claim 4, wherein the device in the body is also used to detect the voltage and resistance between the stimulating electrodes to obtain the electrical stimulation response.
The hypoglossal nerve stimulation device according to claim 4, wherein the in-body device adjusts the capacitance value of the second discrete capacitor through load keying modulation.
The hypoglossal nerve stimulation device according to claim 1, wherein the internal device is integrated on a flexible PCB, and the flexible PCB is bent into a sleeve shape.
The hypoglossal nerve stimulation device according to claim 7, wherein the flexible PCB board is formed by stacking a first PCB sub-board and a second PCB sub-board;

The integrated chip and the stimulating electrode are integrated on the first PCB sub-board close to the hypoglossal nerve; the flexible coil is integrated on the second PCB sub-board far away from the hypoglossal nerve, and the integrated The chip is connected to the flexible coil through the coil contact pad on the first PCB sub-board.
The hypoglossal nerve stimulation device according to claim 1, wherein the external device further comprises: a breathing sensor connected to the controller, and the breathing sensor is used to detect the breathing state of the user , sending an apnea alarm to the controller when the user has apnea;

The controller is further configured to send the stimulation signal to the internal device after receiving the apnea alarm.
The hypoglossal nerve stimulation device according to any one of claims 1 to 8, wherein the controller modulates the stimulation information through amplitude shift keying modulation or phase shift keying modulation.