CN113856047B - Hypoglossal nerve stimulation device - Google Patents
Hypoglossal nerve stimulation device Download PDFInfo
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- CN113856047B CN113856047B CN202110970411.3A CN202110970411A CN113856047B CN 113856047 B CN113856047 B CN 113856047B CN 202110970411 A CN202110970411 A CN 202110970411A CN 113856047 B CN113856047 B CN 113856047B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
Abstract
The application relates to the field of medical equipment, and discloses a hypoglossal nerve stimulation device, which comprises: an in vivo device, an in vitro device; the device comprises an integrated chip, a stimulation electrode and a flexible coil, wherein the integrated chip is respectively connected with the stimulation electrode and the flexible coil, the flexible coil is used for receiving energy and stimulation information sent by the external device, the integrated chip is used for generating stimulation pulses according to the received energy and the stimulation information, and the stimulation electrode is used for transmitting the stimulation pulses to the hypoglossal nerve; the external device is arranged on the body surface above the internal device and comprises a coil and a controller, the controller is connected with the coil and used for generating energy and stimulation information, and the coil is used for transmitting the energy and the stimulation information to the internal device. Through splitting the hypoglossal nerve stimulation device into an internal device and an external device which utilize a magnetic induction link formed by an internal coil and an external coil to carry out communication and energy transmission, the volume of the internal device is reduced, and the practicability and the safety are improved.
Description
Technical Field
The embodiment of the application relates to the field of medical instruments, in particular to a hypoglossal nerve stimulation device.
Background
Normally, air smoothly enters the lungs from the mouth and nose through the respiratory tract, and obstruction or narrowing of the respiratory tract during breathing can cause apnea. During sleep, a condition that manifests involuntarily and briefly stopping breathing, in the event that it should be in normal breathing, is known as Obstructive Sleep Apnea (OSA). Typical clinical manifestations are loud snoring, somnolence, insomnia, nocturnal cerebral hypoxia, etc. Without proper diagnosis and treatment, it increases the risk of heart-exchange disease, diabetes, stroke, etc., and even severe OSA patients can be life threatening. The severity of patient apneas can be determined by measuring the Apnea Hypopnea Index (AHI). Adult AHI is normal when less than 5, wherein AHI of 5-15 is mild OSA, AHI of 15-30 is moderate OSA, and AHI of 30-30 is severe OSA. Although Continuous Positive Airway Pressure (CPAP) has a good therapeutic effect on OSA patients, it requires that the patient always wear the mask while sleeping during treatment, and only 50% of patients would like to always wear CPAP while sleeping, so CPAP has only 50% compliance and prevalence with OSA patient treatment. Currently, researchers are developing innovative alternatives. Improving compliance with OSA treatment. Hypoglossal nerve stimulation (HGNS) provides a promising solution as an emerging approach, which stimulates the hypoglossal nerve when the user is in an inspiratory state, causing the sublingual muscle to contract, thereby expanding the patient's respiratory tract. The HGNS is arranged in a patient, whether the patient is in an apnea state or not is detected to stimulate hypoglossal nerves, a breathing channel is opened, the normal breathing of the patient is assisted to have a success rate of 76%, and the apnea-hypopnea index (AHI) of the patient is enabled to be smaller than 5.
The current hypoglossal nerve stimulation system is bulky and consists of three main implantable components, a respiration sensor, a stimulation generator and a stimulation electrode. The respiration sensor detects the breathing pattern by sensing the bio-impedance of the chest wall movement and transmits information to the electrical stimulation generator via the lead. The electrical stimulation generator then provides electrical stimulation pulses to the stimulation electrodes, which deliver stimulation signals to the hypoglossal nerve. A patient with respiratory interruption receiving electrical stimulation therapy is required to undergo three open surgeries. The first incision is positioned at the lower edge of the patient's right submandibular gland, distal to the patient's hypoglossal nerve, and is used to place the stimulation electrode. Stimulation of the distal end of the hypoglossal nerve allows the tongue to extend forward, thereby maintaining the respiratory tract unobstructed. The second incision was made parallel to the ribs, in the middle region of the third and fourth ribs. This incision is used to place a respiration sensor, detect the respiration state by sensing the bio-impedance of the chest wall motion, determine if the patient is in the expiratory or inspiratory state, and communicate this information to the stimulus generator. The stimulus generator receives information detected by the respiration sensor and provides a stimulus signal to the stimulus electrode. The stimulation generator is equivalent to a central system and is the most central device in the implanted hypoglossal nerve stimulation system. The opening for placement of the stimulation generator is 2-4 cm below the right collarbone. All three implant components need to be connected by leads that are implanted in the body.
However, in order to place the hypoglossal nerve stimulation system, the patient needs to perform equipment implantation through multiple operations or operations with multiple wounds, the operation site is multiple, the wounds are large, postoperative complications such as pain and inflammation are easy to occur, the three main components are connected through wires, the effects of physical activities are relatively large, the failure is easy to occur, potential safety hazards exist, the service life of a power supply battery of the hypoglossal nerve stimulation system is limited, the battery needs to be replaced by a re-operation after the battery is exhausted, and secondary wounds can be brought to the patient.
Disclosure of Invention
The main aim of the embodiment of the application is to provide a hypoglossal nerve stimulation device, which is applied to respiratory interruption treatment, aims to reduce the volume of the hypoglossal nerve stimulation device implanted in a user, reduce the operation times and the wound area of a patient, avoid potential safety hazards caused by a lead connected with implanted equipment and secondary wounds caused to the user when a battery is replaced by internal battery power supply, and improve the reliability and the practicability of the hypoglossal nerve stimulation device.
To achieve the above object, embodiments of the present application provide a hypoglossal nerve stimulation device, including: an in vivo device, an in vitro device; the device comprises an integrated chip, a stimulation electrode and a flexible coil, wherein the integrated chip is respectively connected with the stimulation electrode and the flexible coil, the flexible coil is used for receiving energy and stimulation information sent by the external device, the integrated chip is used for generating stimulation pulses according to the received energy and the stimulation information, and the stimulation electrode is used for transmitting the stimulation pulses to the hypoglossal nerve; the external device is arranged on the body surface above the internal device, the external device comprises a coil and a controller, the controller is connected with the coil and used for generating energy and stimulation information, and the flexible coil is used for transmitting the energy and the stimulation information to the internal device.
According to the hypoglossal nerve stimulation device, the hypoglossal nerve stimulation device is divided into an in-vivo device and an in-vitro device, a flexible coil contained in the in-vivo device and a coil contained in the in-vitro device form a magnetic induction link, the in-vivo device and the in-vitro device conduct energy transmission and data exchange through the magnetic induction link, the in-vitro device sends energy and stimulation information to the in-vivo device, and after receiving the energy transmitted by the in-vitro device, an in-vivo circuit is started to enter a working state, stimulation information is transmitted according to the in-vitro device, specific stimulation pulses are generated, and the stimulation pulses are transmitted to the hypoglossal nerve through a stimulation electrode, so that obstructive apnea of a user is treated; the sublingual nerve stimulation device is split into the highly integrated in-vivo device and the in-vitro device, so that the volume of the device which needs to be implanted into a user is greatly reduced, the times of the operation needed by the user and the operation wound area are reduced, and the pain caused by the operation is reduced; communication and energy transmission between the internal device and the external device are realized through the magnetic induction link formed by the coils, wires and power sources implanted in the user body are not required to be arranged, the damage to the user caused by device failure or potential safety hazard possibly caused by the movement of the user body is avoided, and secondary damage to the user caused by battery replacement is avoided, so that the safety and the practicability of the whole device are improved.
Drawings
One or more embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings.
FIG. 1 is a schematic diagram of a hypoglossal nerve stimulation device in accordance with an embodiment of the present invention;
FIG. 2 is a schematic illustration of the in vivo device installation of a hypoglossal nerve stimulation device in accordance with an embodiment of the present invention;
FIG. 3 is a schematic view of a first PCB sub-board structure of an in-vivo device of a hypoglossal nerve stimulation device in an embodiment of the present invention;
FIG. 4 is a schematic diagram of a second PCB sub-board structure of an in-vivo device of a hypoglossal nerve stimulation device in an embodiment of the present invention;
FIG. 5 is a schematic circuit diagram of a hypoglossal nerve stimulation device according to an embodiment of the present invention;
fig. 6 is a schematic structural view of another hypoglossal nerve stimulation device in an embodiment of the present invention.
Detailed Description
It is known from the background art that, when the hypoglossal nerve stimulation system is adopted for a patient, in order to place the hypoglossal nerve stimulation system, the device implantation is required to be performed through multiple operations or operations with multiple wounds, the operation positions are multiple, the wounds are large, postoperative complications such as pain and inflammation are easy to occur, the three main components are connected through wires, the effects of physical activities are relatively large, the failure is easy to occur, potential safety hazards exist, the service life of a power supply battery of the hypoglossal nerve stimulation system is limited, and the battery needs to be replaced by a re-operation after the battery is exhausted, so that secondary wounds can be brought to the patient. Therefore, how to reduce the injury and pain to the patient during the placement and use of the hypoglossal nerve stimulation device and to improve the practicality and safety of the hypoglossal nerve stimulation device is an urgent problem to be solved.
To solve the above-mentioned problems, embodiments of the present application provide a hypoglossal nerve stimulation device applied to respiratory interrupt treatment, including: an in vivo device, an in vitro device; the device comprises an integrated chip, a stimulation electrode and a flexible coil, wherein the integrated chip is respectively connected with the stimulation electrode and the flexible coil, the flexible coil is used for receiving energy and stimulation information sent by the external device, the integrated chip is used for generating stimulation pulses according to the received energy and the stimulation information, and the stimulation electrode is used for transmitting the stimulation pulses to the hypoglossal nerve; the external device is arranged on the body surface above the internal device, the external device comprises a coil and a controller, the controller is connected with the coil, the controller is used for generating energy and stimulation information, and the coil is used for transmitting the energy and the stimulation information to the internal device.
According to the hypoglossal nerve stimulation device provided by the embodiment of the application, the hypoglossal nerve stimulation device is divided into an in-vivo device and an in-vitro device, a flexible coil contained in the in-vivo device and a coil contained in the in-vitro device form a magnetic induction link, the in-vitro device and the in-vivo device transmit energy and stimulation information to the in-vivo device through the magnetic induction link, the in-vivo device starts an in-vivo circuit to enter a working state after receiving the energy transmitted by the in-vitro device, specific stimulation pulses are generated according to the stimulation information transmitted by the in-vitro device, and the stimulation pulses are transmitted to the hypoglossal nerve through a stimulation electrode, so that obstructive apnea of a user is treated; the hypoglossal nerve device is split into the highly integrated in-vivo device and the in-vitro device, so that the volume of the device which needs to be implanted into the body of a user is greatly reduced, the times of the operation needed by the user and the operation wound area are reduced, and the pain caused by the operation is reduced; communication and energy transmission between the internal device and the external device are realized through the magnetic induction link formed by the coils, wires and power sources implanted in the user body are not required to be arranged, the damage to the user caused by device failure or potential safety hazard possibly caused by the movement of the user body is avoided, and secondary damage to the user caused by battery replacement is avoided, so that the safety and the practicability of the whole device are improved.
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the embodiments of the present application will be described in detail below with reference to the accompanying drawings. However, as will be appreciated by those of ordinary skill in the art, in the various embodiments of the present application, numerous technical details have been set forth in order to provide a better understanding of the present application. However, the technical solutions claimed in the present application can be implemented without these technical details and with various changes and modifications based on the following embodiments. The following embodiments are divided for convenience of description, and should not be construed as limiting the specific implementation of the present application, and the embodiments may be mutually combined and referred to without contradiction.
The hypoglossal nerve stimulation device described in the present application will be specifically described with reference to specific examples, and the following details are provided only for easy understanding, and are not necessary to implement the present embodiment.
A first aspect of the embodiments of the present invention provides a hypoglossal nerve stimulation device for use in respiratory interrupt therapy, the overall structure of the hypoglossal nerve stimulation device referring to fig. 1, comprising:
the in-vivo device 101 is mounted at the far end of the hypoglossal nerve, the in-vivo device comprises an integrated chip, a stimulation electrode and a flexible coil, the integrated chip is connected with 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 stimulation pulses according to the received energy and the stimulation information, and the stimulation electrode is used for transmitting the stimulation pulses to the hypoglossal nerve.
Specifically, the hypoglossal nerve stimulation device comprises an in-vivo device and an in-vitro device, wherein the in-vivo device is implanted into the far end of a hypoglossal nerve in a user through operation, after the hypoglossal nerve stimulation device starts to work, the in-vivo device receives energy and stimulation information transmitted by the in-vitro device through a flexible coil, then a highly integrated HGNS chip in the in-vivo device enters a working state after receiving the energy transmitted by the in-vitro device, demodulates and analyzes the received stimulation information, generates specific stimulation pulses according to the stimulation information, and transmits the stimulation pulses to the hypoglossal nerve through a connected stimulation electrode so as to treat the symptoms of the user apnea.
In one example, the in-vivo device is integrated on a flexible PCB board that is folded into a sleeve shape. The installation mode of the in-vivo device is shown in fig. 2, the in-vivo device 201 which is highly integrated on the flexible PCB and bent into a sleeve shape is wrapped on the periphery of the distal end of the hypoglossal nerve 202 of the user as far as possible, and the in-vivo device is highly integrated on the flexible PCB by selecting the flexible PCB as a substrate of the in-vivo device, so that the volume of the in-vivo device is greatly reduced, and the in-vivo device is conveniently implanted into the user through a small wound; the flexible PCB of the integrated internal device is bent into the oversleeve shape to form the nerve oversleeve capable of wrapping the hypoglossal nerve, so that the integrated internal device can be wrapped on the periphery of the distal end of the hypoglossal nerve as far as possible after being packaged by a biocompatible flexible material, and the possibility of movement of the internal device caused by movement is reduced while the stimulation pulse is accurately transmitted to the hypoglossal nerve through the stimulation electrode.
In another example, the flexible PCB 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 a first PCB (printed circuit board) of the hypoglossal nerve; the flexible coil is integrated on a second PCB sub-board far away from the hypoglossal nerve, and the integrated chip is connected with the flexible coil through a coil contact pad on the first PCB sub-board. When the distal hypoglossal nerve is wrapped by the in-vivo device, the in-vivo device has a surface which is clung to the hypoglossal nerve and a surface which is relatively far away from the hypoglossal nerve, in order to ensure that the stimulation pulse which is accurately sent to the hypoglossal nerve and the high-efficiency communication and energy transmission are carried out with the in-vitro device, a flexible PCB board is made into a composite structure with an upper layer and a lower layer, which is formed by overlapping two flexible PCB sub-boards, a highly integrated HGNS chip and a stimulation electrode are integrated on a first PCB sub-board which is closer to the hypoglossal nerve, one first PCB sub-board structure schematic diagram in the embodiment is shown in figure 3, and the first PCB sub-board comprises a highly integrated HGNS chip 301, upper and lower stimulation electrodes 302 and 303 and contact pads 304 and 305 which are used for connecting flexible coils on a second flexible PCB sub-board; a schematic diagram of a second PCB sub-board structure in this embodiment is shown in fig. 4, and the second PCB sub-board includes a flexible coil 403, and contact pads 401 and 402 for connecting the flexible coil and the HGNS chip. The flexible coil is integrated on a second PCB (printed Circuit Board) which is farther from the hypoglossal nerve than the first PCB, the flexible coil is connected with the HGNS chip through contact pads on the first PCB and the second PCB, the first PCB and the second PCB are overlapped together, the first PCB is packaged into a sleeve shape by using a biocompatible material, the first PCB is used as the inner side of the sleeve, and the second PCB is used as the outer side of the sleeve to wrap the hypoglossal nerve. The volume of the internal device is reduced as much as possible, the internal device is ensured to accurately interact with the external device for stimulating information and transmitting energy, the internal device is prevented from moving due to human body movement, and the hypoglossal nerve can be accurately electrically stimulated.
The extracorporeal device 102 is mounted on the body surface above the in-vivo device, the extracorporeal device comprising a coil and a controller, the controller being connected to the coil, the controller being for generating energy and stimulation information, the coil being for transmitting the energy and stimulation information to the in-vivo device.
Specifically, the external portion of the hypoglossal nerve stimulation device is mounted on the body surface above the internal device, for example, the external portion is hung on the ear through a hook-type bracket, the main body of the external device is close to the cheek of the user or placed on the surface of the neck of the user, the coil in the external device can be close to the upper portion of the internal device as much as possible, a magnetic induction link is formed by the coil of the external device and the flexible coil of the internal device for interaction of energy and stimulation information, after the hypoglossal nerve stimulation device starts working, the controller of the external device generates stimulation information for controlling the internal device to send stimulation pulses and energy for supplying energy to the internal device, and the energy and the stimulation information are sent to the internal device through the coil connected by the controller.
In one example, the extracorporeal device further comprises a respiration sensor connected to the controller, the respiration sensor is used for detecting the respiration state of the user, and sending an apnea alarm to the controller when the user has an apnea; the controller is also used for sending energy and stimulation information to the internal device through a magnetic induction link consisting of the coil and the flexible coil after receiving the apnea alarm. The external device is arranged in the external device and is used for sensing the breathing state of a user, after the breathing pause device starts to work, the breathing sensor starts to detect the breathing state of the user in real time, whether the user has the breathing pause symptoms or not is judged, when the user does not have the breathing pause symptoms, the external device does not send energy and stimulation information to the internal device, the internal device is in a closed state, the external device is kept in a standby state, when the breathing sensor detects that the user has the breathing pause symptoms, the breathing sensor detects that the user is in an expiration state or an inspiration state, when the user has the breathing pause, the breathing sensor generates an breathing pause warning and sends the breathing pause warning to the controller, after receiving the warning information of the breathing pause warning, the controller sends energy and stimulation information to the internal device according to pulse parameters of the stimulation pulse, the internal device enters the working state after receiving the energy, demodulates the received stimulation information, and generates specific stimulation pulse according to a demodulation result, and the generated stimulation pulse is transmitted to the sublingual nerve of the user through the stimulation electrode.
In addition, in practical application, the breathing sensor can be independently installed in the external device and connected with the controller, and can also be directly integrated in the controller in an integrated mode, so that the volume of the external device is further reduced. The specific installation mode of the respiratory sensor in the extracorporeal device is not limited. By adding the breathing sensor and sending the stimulation pulse to the user when the user is in the apnea state, the apnea device is prevented from being kept in the working state all the time, the overall energy consumption of the apnea stimulation device is further reduced, and the charging time interval of the external device is increased; by sending the stimulation pulse only when the user needs to treat the apnea symptoms, and not sending the stimulation pulse in the rest time, the user is prevented from tolerating the stimulation pulse due to long-time electric stimulation, and the long-term effectiveness of the apnea device is ensured.
In another example, the in-vivo device further comprises: the first discrete capacitor and the flexible coil form a resonant circuit; the second discrete capacitor is used for adjusting the capacitance value according to the electric stimulation response of the user to the stimulation pulse, and the flexible coil is also used for transmitting the electric stimulation response to the external device; the external device is also used for receiving the electric stimulation response, and adjusting the sent stimulation information according to the electric stimulation response to form a closed-loop regulating circuit of the stimulation pulse. For example, as shown in fig. 5, a schematic circuit structure of a hypoglossal nerve stimulation device is shown, a power supply, a microcontroller, a modulator, a demodulator and an amplifier are integrated in a controller of an external device, meanwhile, the external device also comprises a discrete capacitor C1 and a coil L1, a parasitic resistor R1 of the external device, the coil L1 in the external device and the discrete capacitor C1 form a resonant loop and are connected with the controller, the control of the controller is realized, a highly integrated HGNS chip in the internal device comprises a power supply processing unit and a data communication unit, the power supply processing unit comprises a rectifier and a voltage regulator, and the data communication unit comprises a modulator, a demodulator, a microcontroller, a bipolar current pulse generator and an amplifier; the HGNS chip is connected with an upper stimulating electrode and a lower stimulating electrode which transmit stimulating pulses to the hypoglossal nerve, a resonance loop formed by a first discrete capacitor C2 and a flexible coil L2, the flexible coil L2 is connected with the other two ports of the HGNS chip, a module for detecting stimulating information between the stimulating electrodes is also contained in a data communication unit of the HGNS chip, the module consists of an amplifier and a modulator, and the modulating information reflects the change of a second discrete capacitor in the human body and is transmitted to an external device through the flexible coil in the human body.
In the working process of the hypoglossal nerve stimulation device, when a controller in the external device senses that a patient is in an apnea state, according to stimulation pulse parameters corresponding to stimulation pulses of the hypoglossal nerve to be sent, a resonance loop formed by a discrete capacitor and a coil is utilized to provide energy for the internal device and send stimulation information; after receiving the stimulation information sent by the external device, the data communication unit demodulates the received stimulation information, and the microcontroller controls the bipolar current pulse generator to generate specific stimulation pulses according to the demodulation result of the demodulator, and transmits the stimulation pulses to the hypoglossal nerve through the upper and lower stimulation electrodes, so as to stimulate the hypoglossal nerve. The bipolar current stimulation can reduce or eliminate charge accumulation of the body between the electrodes, and avoid damage to the body due to overheating of the body.
After the hypoglossal nerve device transmits the stimulating pulse to the hypoglossal nerve, the microcontroller of the in-vivo device can also detect the electric stimulating response of the user to the pulse, then the microcontroller controls the modulator to carry out communication coding modulation on the detected electric stimulating response information, adjusts the capacitance value of the second discrete capacitor, and transmits the modulated electric stimulating response information to the in-vitro device through the flexible coil. After the external device receives the electric stimulation response information transmitted by the internal device through the coil, the electric stimulation response information is decoded through the demodulator, then the controller adjusts the stimulation information to be sent to the internal device according to the received electric stimulation response information fed back by the internal device, the adjusted stimulation information is sent to the internal device through the modulator and the amplifier, and the internal device adjusts the stimulation pulse sent to the hypoglossal nerve according to the received stimulation information. The two-way communication of the magnetic induction link and the feedback regulation of the stimulation pulse are utilized by the in-vivo device and the in-vitro device, a closed loop regulation loop of the stimulation pulse is formed between the in-vivo device and the in-vitro device, the damage to the user caused by the stimulation pulse received by the user or the change of the physical state of the user is avoided, the original stimulation pulse can not play a good therapeutic role on the user, and the effectiveness and the reliability of the treatment of the breathing pause of the hypoglossal nerve stimulation device are further improved by utilizing the closed loop regulation mode. In addition, the step of performing closed-loop adjustment of the stimulation pulse according to the electrical stimulation response information may extend through the whole use process of the sublingual stimulation device, or may be selectively opened, which is not limited in this embodiment.
In another example, the in-vivo device is also used to detect voltage and resistance between stimulation electrodes to obtain an electrical stimulation response. After the stimulation pulse is sent to the hypoglossal nerve by the in-vivo device according to the received energy and the stimulation information, the response of the user to the stimulation pulse can change in real time, the displayed electrical characteristics are that the voltage and the resistance between the electrodes change in real time, the microcontroller measures the voltage value and the resistance value between the upper and lower stimulation electrodes, so that the excitation degree of the user's hypoglossal nerve after the electrical stimulation by the stimulation pulse is obtained, the voltage value and the resistance value between the upper and lower stimulation electrodes are used for representing the electrical stimulation response information of the user, the electrical stimulation response information is transmitted to the in-vitro device, the in-vitro device demodulates the electrical stimulation response information after receiving the electrical stimulation response information, and when the voltage value and the resistance value do not exist in a preset interval, the stimulation information sent to the in-vivo device is readjusted in a feedback adjustment mode, so that the voltage and the resistance between the electrodes fall in the preset interval under the stimulation of the adjusted stimulation pulse. By detecting the voltage value and the resistance value between the stimulation electrodes, the response of the hypoglossal nerve of the user to the stimulation pulse is accurately obtained, reliable user response data is provided for subsequent feedback adjustment, and the effectiveness of the stimulation pulse treatment is further ensured.
In another example, the in-vivo device adjusts the capacitance value of the second discrete capacitor by means of load keying modulation. After the in-vivo device detects the electric stimulation response of the user hypoglossal nerve to the stimulation pulse, the in-vivo device adjusts the capacitance access state of the second discrete capacitor by utilizing a load keying modulation mode through the in-vivo microcontroller, changes the capacitance value of the second discrete capacitor, and realizes the information coding of the electric stimulation response. The switch response time for controlling the change of the capacitance value is greatly reduced by utilizing a load keying modulation mode, and the detected user electric stimulation response information is transmitted to the external device in time. In practical application, the C-MOS transistor can be used as a switch of the second discrete capacitor, the high-efficiency on-off characteristic of the C-MOS transistor is utilized to replace a switch which needs to be newly added, the C-MOS switch is integrated in an in-vivo integrated circuit, the in-vivo microcontroller is used for controlling the on-off state of the C-MOS, the capacitance value adjusting efficiency is ensured, meanwhile, the volume of the in-vivo device is further reduced, and the specific selection of the switch for controlling the capacitance value of the second discrete capacitor is not limited.
In another example, the controller modulates the stimulation information via amplitude shift keying modulation or phase shift keying modulation. The controller is integrated with the microcontroller, the modulator, the demodulator and the amplifier, when the apnea stimulation device enters a working state, the microcontroller generates stimulation information sent to the internal device through the modulator according to pulse stimulation parameters required to be transmitted to the hypoglossal nerve, the stimulation information can be modulated by adopting an amplitude shift keying modulation mode or a phase shift keying modulation mode to be sent stimulation signals, the simplest stimulation signal modulation can be realized when the working mode of the modulator is set to be the amplitude shift keying modulation mode, the volume of the controller can be reduced as far as possible, the generated stimulation signals can be transmitted to the internal device through the lowest energy loss when the working mode of the modulator is set to be the phase shift keying modulation mode, the overall energy consumption of the external device is reduced, and the charging time of the external device is prolonged.
In practical application, the modulation mode adopted in the communication between the in-vivo device and the in-vitro device can be selected and changed according to the actual situation or needs, and the specific modulation mode is not limited in this embodiment.
In another example, the apnea stimulating device further comprises: the remote controller is in communication connection with the external device and is used for receiving the stimulation parameters set by the user and sending the stimulation parameters to the external device; the extracorporeal device is also used for adjusting the stimulation information according to the stimulation parameters. A schematic of an apnea apparatus including a remote control is shown in fig. 6, and includes an in-vivo apparatus 601 for delivering a stimulating pulse to a hypoglossal nerve and feeding back electrical stimulation response information of a user; an external device 602 for transmitting energy and stimulation information to the internal device, the transmitted stimulation information being adjusted according to an electrical stimulation response of the internal device; the remote controller 603 is in communication connection with the external device, the remote controller comprises a micro-control regulator and a communication unit, the micro-control regulator and the communication unit can also be integrated in the microcontroller, the micro-control regulator is used for receiving parameter settings of stimulation pulses sent to the hypoglossal nerve by a user or a doctor, the parameters comprise the intensity, the duration and the like of the stimulation pulses, the received stimulation parameters are sent to the external device, and the external device adjusts stimulation information required to be sent to the internal device according to the received stimulation parameters. Through the communication connection of the remote controller and the external device, the stimulation pulse sent to the hypoglossal nerve of the user can be adjusted under the condition that the internal device is not taken out, so that the need of resetting the stimulation pulse by a secondary operation after the user generates tolerance to the specific pulse is avoided, and the practicability of the apnea device is improved.
In addition, can also set up the breathing inductor in the remote controller, no longer set up the breathing inductor in the external device, whether the breathing inductor through setting up in the remote controller detects user's emergence apnea symptom and breathing state, when detecting that the user takes place the apnea state, and be in the apnea state of breathing in, the breathing inductor provides warning information to the microcontroller, after receiving the warning information, the microcontroller received the last stimulation parameter that sets up of user or prestored in advance the stimulation parameter, sent the instruction that carries the stimulation parameter to the external device, control the external device and send energy and stimulation information to the internal device according to the stimulation parameter, begin carrying out specific electrical stimulation to the user. Through setting up the breathing inductor in the remote controller, reduce the volume of the external device that is located the body surface, avoided external device to be in standby state in real time, internal device and external device can be in the state of closing when not needing to send the stimulation pulse, send the stimulation pulse only after specific time point according to the instruction of remote controller, further reduce whole energy consumption.
In addition, after the in-vivo device feeds back the electrical stimulation response information of the user to the stimulation pulse to the in-vitro device, the in-vitro device can also transmit the electrical stimulation response information to the remote controller, the user can adjust the stimulation parameters by himself according to the electrical stimulation response information displayed on the remote controller, and the microcontroller of the remote controller can adjust the stimulation parameters according to the feedback adjustment mechanism and send the adjusted stimulation parameters to the in-vitro device. The stimulation pulse is regulated in a closed-loop control mode, so that the effectiveness of the stimulation pulse is ensured, and the injury of the stimulation pulse to a user is avoided.
In practical application, the respiration sensor may be set in the external device according to practical needs or in the remote controller, and the specific setting mode of the respiration sensor is not limited in this embodiment.
In another example, the extracorporeal device is communicatively coupled to the remote control via a data line, bluetooth, or wireless network. The remote controller and the external device can be directly connected through a data line, so that high-speed accurate transmission of signals is realized, and the accuracy of stimulation parameters is ensured; the wireless network can be connected in a data transmission mode, so that the limitation of connecting wires when the wireless network is connected in a physical connection mode is avoided; the device can be connected with the external device in a Bluetooth pairing mode, so that the problem that the hypoglossal nerve stimulation cannot be accurately and efficiently performed in a scene with limited local area network use is avoided, the external device and the remote controller are connected through a plurality of possible communication connection modes, the accuracy and the efficiency of data communication between the external device and the remote controller are ensured, and the practicability and the reliability of the hypoglossal nerve stimulation device are further ensured.
Moreover, it should be understood that the above steps of the various methods are divided, for clarity of description, and may be combined into one step or split into multiple steps when implemented, so long as they include the same logic relationship, and all the steps are within the scope of protection of the present patent; it is within the scope of this patent to add insignificant modifications to the algorithm or flow or introduce insignificant designs, but not to alter the core design of its algorithm and flow.
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific embodiments in which the present application is implemented and that various changes in form and details may be made therein without departing from the spirit and scope of the present application.
Claims (8)
1. A hypoglossal nerve stimulation device, comprising: an in vivo device, an in vitro device;
the device comprises an integrated chip, a stimulation electrode and a flexible coil, wherein the integrated chip is respectively connected with the stimulation electrode and the flexible coil, the flexible coil is used for receiving energy and stimulation information sent by the device outside the body, the integrated chip is used for generating stimulation pulses according to the received energy and the stimulation information, and the stimulation electrode is used for transmitting the stimulation pulses to the hypoglossal nerve;
the external device is arranged on the body surface above the internal device, the external device comprises a coil and a controller, the controller is connected with the coil and is used for generating the energy and the stimulation information, and the coil is used for transmitting the energy and the stimulation information to the internal device;
the in-vivo device is integrated on a flexible Printed Circuit Board (PCB), the flexible PCB is bent into a sleeve shape, and the flexible PCB is formed by overlapping a first PCB sub-board and a second PCB sub-board;
the integrated chip and the stimulating electrode are integrated on a first PCB (printed circuit board) which is 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 chip is connected with the flexible coil through a coil contact pad on the first PCB sub-board.
2. The hypoglossal nerve stimulation device of claim 1, further comprising: a remote controller;
the remote controller is in communication connection with the external device and is used for receiving the stimulation parameters set by a user and sending the stimulation parameters to the external device;
the external device is also used for adjusting the stimulation information according to the stimulation parameters.
3. The hypoglossal nerve stimulation device of claim 2, wherein the extracorporeal device is communicatively coupled to the remote control via a data line, bluetooth, or wireless network.
4. The hypoglossal nerve stimulation device of claim 1, wherein the in vivo device further comprises: a first discrete capacitance and a second discrete capacitance, the first discrete capacitance being used to form a resonant circuit with the flexible coil; the second discrete capacitor is used for adjusting a capacitance value according to the electric stimulation response of a user to the stimulation pulse, and the flexible coil is also used for transmitting the electric stimulation response to the external device;
the external device is also used for receiving the electric stimulation response, and adjusting the sent stimulation information according to the electric stimulation response to form a closed-loop regulating circuit of the stimulation pulse.
5. The hypoglossal nerve stimulation device of claim 4, wherein: the in-vivo device is also used for detecting voltage and resistance between the stimulation electrodes and acquiring the electrical stimulation response.
6. The hypoglossal nerve stimulation device of claim 4, wherein the in-vivo device adjusts the capacitance value of the second discrete capacitor by means of load keying modulation.
7. The hypoglossal nerve stimulation device of claim 1, wherein the extracorporeal device further comprises: the respiration sensor is connected with the controller and is used for detecting the respiration state of a user and sending an apnea alarm to the controller under the condition that the user has apnea;
the controller is further configured to send the stimulation information to the in-vivo device after receiving the apnea alarm.
8. The hypoglossal nerve stimulation device according to any one of claims 1-7, wherein the controller modulates the stimulation information by amplitude shift keying modulation or phase shift keying modulation.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110970411.3A CN113856047B (en) | 2021-08-23 | 2021-08-23 | Hypoglossal nerve stimulation device |
| PCT/CN2022/092695 WO2023024587A1 (en) | 2021-08-23 | 2022-05-13 | Hypoglossal nerve stimulation device |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110970411.3A CN113856047B (en) | 2021-08-23 | 2021-08-23 | Hypoglossal nerve stimulation device |
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| CN113856047B (en) * | 2021-08-23 | 2023-05-26 | 西湖大学 | Hypoglossal nerve stimulation device |
| CN117065210A (en) * | 2023-05-31 | 2023-11-17 | 上海杉翎医疗科技有限公司 | Device for stimulating peripheral nerves |
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| WO2023024587A1 (en) | 2023-03-02 |
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