CN113856047A - Sublingual nerve stimulation device - Google Patents
Sublingual nerve stimulation device Download PDFInfo
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- CN113856047A CN113856047A CN202110970411.3A CN202110970411A CN113856047A CN 113856047 A CN113856047 A CN 113856047A CN 202110970411 A CN202110970411 A CN 202110970411A CN 113856047 A CN113856047 A CN 113856047A
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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, discloses a sublingual nerve stimulation device, includes: in vivo devices, in vitro devices; the in-vivo device is arranged at the far end of the hypoglossal nerve and 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 in-vitro device, the integrated chip is used for generating stimulation pulses according to the received energy and stimulation information, and the stimulation electrode is used for transmitting the stimulation pulses to the hypoglossal nerve; the extracorporeal device is mounted on a body surface above the intracorporeal device and 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 intracorporeal device. The sublingual nerve stimulation device is divided into the in-vivo device and the in-vitro device which are communicated and transmit energy by using the magnetic induction link formed by the in-vivo coil and the in-vivo coil, so that the volume of the in-vivo 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 sublingual nerve stimulation device.
Background
Normally, air smoothly enters the lungs from the mouth and nose through the respiratory tract, and during breathing, the obstruction or narrowing of the respiratory tract can cause apnea. A state during sleep that exhibits involuntary brief cessation of breathing in the event that normal breathing is expected is called Obstructive Sleep Apnea (OSA). Typical clinical manifestations are loud snoring, lethargy, insomnia, nocturnal cerebral hypoxia, etc. Without proper diagnosis and treatment, it increases the risk of cardioverter-related diseases, diabetes, stroke, etc., and even serious OSA patients are life threatening. The severity of the patient's apnea can be determined by measuring the Apnea Hypopnea Index (AHI). The adult has normal AHI less than 5, mild OSA with AHI less than 15 and less than 5, moderate OSA with AHI less than 30 and more than 15, and severe OSA with AHI greater than or equal to 30. Although Continuous Positive Airway Pressure (CPAP) has a good therapeutic effect on OSA patients, the treatment requires that the patient wear the mask all the time while sleeping, and only 50% of patients are willing to wear CPAP all the time while sleeping, so CPAP has only 50% compliance and prevalence with the treatment of OSA patients. Researchers are currently working on developing innovative alternatives. Improving compliance in the treatment of OSA. Hypoglossal nerve stimulation (HGNS), an emerging method, offers a promising solution to stimulate the hypoglossal nerve when the user is inhaling, causing the hypoglossal muscles to contract, thereby enlarging the patient's breathing passage. The HGNS is arranged in a patient body, detects whether the patient is in an apnea state, stimulates the hypoglossal nerve, opens a breathing channel, helps the patient to breathe normally with a success rate of up to 76 percent, and can enable the Apnea Hypopnea Index (AHI) of the patient to be less than 5.
At present, the sublingual nerve stimulation system is bulky and mainly comprises three implantable components, namely 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 motion and transmits the information to the electrical stimulation generator over 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 needs to undergo three open surgeries. The first incision is made at the lower margin of the patient's right submandibular gland, distal to the patient's hypoglossal nerve, for placement of the stimulating electrodes. Stimulating the distal end of the hypoglossal nerve allows the tongue to extend forward, thereby maintaining an unobstructed airway. The second incision was made parallel to the ribs, in the middle of the third and fourth ribs. The incision is used for placing a respiration sensor, detecting the respiration state by sensing the biological impedance of the chest wall movement to judge whether the patient is in an expiration state or an inspiration state, and transmitting the information to the stimulation generator. The stimulation generator receives information detected by the respiration sensor and provides a stimulation signal to the stimulation electrode. The stimulation generator is equivalent to a central system and is the most central device in an implanted sublingual nerve stimulation system. The opening for placing the stimulus generator is 2-4 cm below the right clavicle. All three implant components need to be connected by a lead implanted in the body.
However, for a patient, in order to place the hypoglossal nerve stimulation system, the patient needs to perform multiple operations or multiple-wound operations to implant equipment, the number of operation sites is large, the wound is large, postoperative complications such as pain and inflammation are prone to occur, the three main components are connected through leads, the influence of physical activity is large, failure is prone 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 again after the battery power is exhausted, and secondary wound is brought to the patient.
Disclosure of Invention
The main aim at of this application embodiment provides a hypoglossal nerve stimulation device, uses and respiratory interruption treatment, aims at reducing the volume of implanting the internal hypoglossal nerve stimulation device of user, reduces patient's operation number of times and wound area, avoids implanting the potential safety hazard that the wire that equipment is connected brought and internal battery powered for the secondary wound that the user brought when carrying out the battery change, improves hypoglossal nerve stimulation device's reliability and practicality.
To achieve the above object, an embodiment of the present application provides a sublingual nerve stimulation device, including: in vivo devices, in vitro devices; the in-vivo device is arranged at the far end of the hypoglossal nerve and 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 in-vitro device, the integrated chip is used for generating stimulation pulses according to the received energy and stimulation information, and the stimulation electrode is used for transmitting the stimulation pulses to the hypoglossal nerve; the in-vitro device is arranged on the body surface above the in-vivo 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 flexible coil is used for transmitting the energy and the stimulation information to the in-vivo device.
The sublingual nerve stimulation device provided by the embodiment of the application is divided into an in-vivo device and an in-vitro device, wherein 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 carry out energy transmission and data exchange through the magnetic induction link, the in-vivo device sends energy and stimulation information to the in-vivo device, the in-vivo device starts an in-vivo circuit to enter a working state after receiving the energy transmitted by the in-vitro device, generates a specific stimulation pulse according to the stimulation information transmitted by the in-vitro device, and transmits the stimulation pulse to the sublingual nerve through a stimulation electrode to treat obstructive apnea of a user; by splitting the hypoglossal nerve stimulation device into a highly integrated in-vivo device and an in-vitro device, the volume of the device to be implanted into the body of a user is greatly reduced, the times of operations and the area of an operation wound of the user are reduced, and the pain caused by the operations is reduced; the magnetic induction link formed by the coils is used for realizing communication and energy transmission between the in-vivo device and the in-vitro device, wires and power sources implanted in the body of a user do not need to be arranged, the problem that the user is damaged due to device failure or potential safety hazards caused by movement of the body of the user is avoided, secondary damage caused by replacement of batteries for the user is avoided, and the safety and the practicability of the whole device are improved.
Drawings
One or more embodiments are illustrated by the corresponding figures in the drawings, which are not meant to be limiting.
FIG. 1 is a schematic structural diagram of a hypoglossal nerve stimulation apparatus in an embodiment of the present invention;
FIG. 2 is a schematic view of the in vivo device installation of a hypoglossal nerve stimulation apparatus in an embodiment of the present invention;
FIG. 3 is a schematic diagram of a first PCB sub-panel configuration of an in-vivo device of the hypoglossal nerve stimulation apparatus in an embodiment of the present invention;
FIG. 4 is a schematic diagram of a second PCB sub-panel configuration of an in-vivo device of the hypoglossal nerve stimulation apparatus in an embodiment of the present invention;
FIG. 5 is a schematic diagram of the electrical circuit configuration of the hypoglossal nerve stimulation apparatus in an embodiment of the present invention;
fig. 6 is a schematic structural diagram of another hypoglossal nerve stimulation apparatus in an embodiment of the present invention.
Detailed Description
As known from the background art, for a patient, in order to place a sublingual nerve stimulation system, multiple operations or operations with multiple wounds are needed for implanting equipment, the number of operation positions is large, the wounds are large, postoperative complications such as pain and inflammation are prone to occur, three main components are connected through leads, the influence of physical activity is large, the situation of failure is prone to occur, potential safety hazards exist, the service life of a power supply battery of the sublingual nerve stimulation system is limited, the battery needs to be replaced through a new operation after the battery power is exhausted, and secondary trauma can be brought to the patient. Therefore, how to reduce the damage and pain to the patient during the placement and use of the sublingual nerve stimulation device and improve the practicability and safety of the sublingual nerve stimulation device is an urgent problem to be solved.
In order to solve the above-mentioned problems, embodiments of the present application provide a hypoglossal nerve stimulation apparatus applied to a respiratory interruption therapy, including: in vivo devices, in vitro devices; the in-vivo device is arranged at the far end of the hypoglossal nerve and 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 in-vitro device, the integrated chip is used for generating stimulation pulses according to the received energy and stimulation information, and the stimulation electrode is used for transmitting the stimulation pulses to the hypoglossal nerve; the in-vitro device is arranged on the body surface above the in-vivo 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 in-vivo device.
The sublingual nerve stimulation device provided by the embodiment of the application is divided into an in-vivo device and an in-vitro device, wherein 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 carry out energy transmission and data exchange through the magnetic induction link, the in-vitro device sends energy and stimulation information to the in-vivo device, the in-vivo device receives the energy transmitted by the in-vitro device and then starts an in-vivo circuit to enter a working state, a specific stimulation pulse is generated according to the stimulation information transmitted by the in-vitro device and is transmitted to the sublingual nerve through a stimulation electrode, and obstructive apnea of a user is treated; by splitting the hypoglossal nerve device into a highly integrated in-vivo device and an in-vitro device, the volume of the device to be implanted into the body of a user is greatly reduced, the times of operations and the area of an operation wound of the user are reduced, and the pain caused by the operations is reduced; the magnetic induction link formed by the coils is used for realizing communication and energy transmission between the in-vivo device and the in-vitro device, wires and power sources implanted in the body of a user do not need to be arranged, the problem that the user is damaged due to device failure or potential safety hazards caused by movement of the body of the user is avoided, secondary damage caused by replacement of batteries for the user is avoided, and the safety and the practicability of the whole device are improved.
To make the objects, 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, it will be appreciated by those of ordinary skill in the art that in the examples of the present application, numerous technical details are set forth in order to provide a better understanding of the present application. However, the technical solution claimed in the present application can be implemented without these technical details and various changes and modifications based on the following embodiments. The following embodiments are divided for convenience of description, and should not constitute any limitation to the specific implementation manner of the present application, and the embodiments may be mutually incorporated and referred to without contradiction.
The sublingual nerve stimulation device described herein will be described in greater detail with reference to specific embodiments, which are provided for the sake of understanding only and are not necessary to practice the present solution.
A first aspect of the embodiments of the present invention provides a sublingual nerve stimulation device for use in respiratory interruption therapy, which is schematically illustrated in overall structure with reference to fig. 1 and includes:
the in-vivo device 101 is installed at the far end of the hypoglossal nerve and comprises an integrated chip, a stimulation electrode and a flexible coil, 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 in-vitro device, the integrated chip is used for generating stimulation pulses according to the received energy and 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 at the far end of the hypoglossal nerve in the body of a user through an 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 a specific stimulation pulse according to the stimulation information, and transmits the stimulation pulse to the hypoglossal nerve through a connected stimulation electrode to realize the treatment of the apnea symptom of the user.
In one example, the in-vivo device is integrated on a flexible PCB that is bent into a sleeve shape. The installation mode of the in-vivo device is schematically 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 far end of the hypoglossal nerve 202 of the user as much as possible, and the in-vivo device is highly integrated on the flexible PCB by selecting the flexible PCB as the 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 body of the user through a small wound; the flexible PCB of the integrated in-vivo device is bent into the shape of the sleeve to form the nerve sleeve which can wrap the hypoglossal nerve, so that the integrated in-vivo device can wrap 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 the in-vivo device moving caused by activity is reduced while the stimulation pulse is accurately sent to the hypoglossal nerve by 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 the first PCB daughter board of the hypoglossal nerve; the flexible coil is integrated on a second PCB daughter 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 daughter board. When the sublingual nerve at the far end is wrapped by the in-vivo device, one surface of the in-vivo device clinging to the sublingual nerve and one surface of the in-vivo device far away from the sublingual nerve exist, in order to ensure that stimulation pulses are accurately sent to the sublingual nerve and efficient communication and energy transmission are carried out with the in-vitro device, the flexible PCB is made into a composite structure with an upper layer and a lower layer and is formed by overlapping two flexible PCB sub-boards, and the highly integrated HGNS chip and the stimulation electrodes are integrated on a first PCB sub-board closer to the sublingual nerve; fig. 4 shows a schematic structural diagram of a second PCB daughter board in this embodiment, the second PCB daughter 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 the second PCB daughter board which is farther away from the hypoglossal nerve relative to the first PCB daughter board, the flexible coil is connected with the HGNS chip through the contact pads on the first PCB daughter board and the second PCB daughter board, the first PCB daughter board and the second PCB daughter board are overlapped together, the flexible coil is packaged into a sleeve shape by using a biocompatible material, the first PCB daughter board is used as the inner side of the sleeve, and the second PCB daughter board is used as the outer side of the sleeve to wrap the hypoglossal nerve. The volume of the in-vivo device is reduced as much as possible, meanwhile, the in-vivo device can accurately carry out interaction and energy transmission of stimulation information with the in-vitro device, the in-vivo device is prevented from moving due to human body movement, and accurate electrical stimulation can be carried out on hypoglossal nerve.
An extracorporeal device 102, the extracorporeal device being mounted on a body surface above the intracorporeal device, the extracorporeal device comprising a coil and a controller, the controller being connected to the coil, the controller being configured to generate energy and stimulation information, the coil being configured to transmit the energy and stimulation information to the intracorporeal device.
Specifically, the external part of the hypoglossal nerve stimulation apparatus is mounted on the body surface above the internal apparatus, for example, hung on the ear by a hook-type holder, the body of the external apparatus is close to the cheek of the user or placed on the surface of the neck of the user, so that the coil in the external apparatus can be as close as possible to the top of the internal apparatus, a magnetic induction link is formed by the coil of the external apparatus and the flexible coil of the internal apparatus for interaction of energy and stimulation information, after the hypoglossal nerve stimulation apparatus starts to operate, the controller of the external apparatus generates stimulation information for controlling the internal apparatus to transmit stimulation pulses and energy for energizing the internal apparatus, and transmits the energy and stimulation information to the internal apparatus through the coil connected to the controller.
In one example, the extracorporeal device further comprises a respiration sensor, the respiration sensor is connected with 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 apnea; the controller is also used for sending energy and stimulation information to the in-vivo device through a magnetic induction link formed by the coil and the flexible coil after receiving the apnea alarm. The breathing sensor for sensing the breathing state of a user is arranged in the external device, after the breathing sensor starts working, the breathing sensor starts to detect the breathing state of the user in real time to judge whether the user has the breathing pause symptom, when the user does not have the breathing pause symptom, 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 maintains a standby state, when the breathing sensor detects that the user has the breathing pause symptom, the breathing sensor detects whether the user is in an expiration state or an inspiration state, when the user has the breathing pause, the breathing sensor generates breathing pause warning and sends the breathing pause warning to the controller, and after the controller receives the warning information of the breathing sensor, the controller sends the energy and the stimulation information to the internal device according to the pulse parameters of the stimulation pulse, the in-vivo device enters a working state after receiving energy, demodulates the received stimulation information, generates a specific stimulation pulse according to a demodulation result, and transmits the generated stimulation pulse to the hypoglossal nerve of the user through the stimulation electrode.
In addition, in practical application, the breathing sensor can be separately installed in the extracorporeal device and connected with the controller, and can also be directly integrated in the controller in an integrated manner, so that the volume of the extracorporeal device is further reduced. The specific installation manner of the breathing sensor in the external device is not limited in this embodiment. By adding the breathing inductor and sending the stimulation pulse to the user when the user has apnea, the phenomenon that the apnea device is always kept in a working state is avoided, the overall energy consumption of the apnea stimulation device is further reduced, and the charging time interval of the extracorporeal device is increased; the stimulation pulse is sent only when the user needs to treat the apnea symptom, and the stimulation pulse is not sent in the rest time, so that 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 reaction of the user to the stimulation pulse, and the flexible coil is also used for transmitting the electric stimulation reaction to the in-vitro device; the in-vitro device is also used for receiving the electrical stimulation reaction, adjusting the sent stimulation information according to the electrical stimulation reaction and forming a closed loop regulation loop of stimulation pulse. For example, a schematic circuit structure diagram of a sublingual nerve stimulation device is shown in fig. 5, 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 further comprises a discrete capacitor C1 and a coil L1, and a parasitic resistor R1 of the external device, the coil L1 and the discrete capacitor C1 in the external device form a resonant circuit and are connected with the controller, the controller controls the external device, 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 stimulation electrode and a lower stimulation electrode which are used for transmitting stimulation pulses to hypoglossal nerves, a resonant 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 stimulation information between the stimulation electrodes is further contained in a data communication unit of the HGNS chip, the module consists of an amplifier and a modulator, and the modulation information reflects the change of the second discrete capacitor in vivo and is transmitted to an extracorporeal device through the flexible coil in vivo.
In the working process of the hypoglossal nerve stimulation device, when a controller in the external device induces that a patient is in an apnea state, energy is provided for the internal device and stimulation information is sent to the internal device by utilizing a resonance circuit formed by a discrete capacitor and a coil according to stimulation pulse parameters corresponding to stimulation pulses of hypoglossal nerves to be sent; the in-vivo device receives energy from the in-vitro device through a resonant circuit formed by a first discrete capacitor and a flexible coil, the in-vivo device transmits the energy transmitted from the in-vitro device to a rectifier and a voltage regulator of a power supply processing unit to supply power to the in-vivo device, a circuit of the in-vivo device is started to enter a working state, after stimulation information sent by the in-vitro device is received, a data communication unit demodulates the received stimulation information, a microcontroller controls a bipolar current pulse generator to generate specific stimulation pulses according to the demodulation result of the demodulator, and the stimulation pulses are transmitted to the hypoglossal nerve through an upper stimulation electrode and a lower stimulation electrode to stimulate the hypoglossal nerve. The bipolar current stimulation is adopted, so that the charge accumulation of the body between the electrodes can be reduced or eliminated, and the body is prevented from being damaged due to overheating.
After the hypoglossal nerve device transmits the stimulation pulse to the hypoglossal nerve, the microcontroller of the in-vivo device can also detect the electrical stimulation response of the user to the pulse, then the microcontroller controls the modulator to perform communication coding modulation on the detected electrical stimulation response information, adjusts the capacitance value of the second discrete capacitor, and transmits the modulated electrical stimulation response information to the in-vitro device through the flexible coil. 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 subsequently transmitted to the internal device according to the received electric stimulation response information fed back by the internal device, the adjusted stimulation information is transmitted to the internal device through the modulator and the amplifier, and the internal device adjusts the stimulation pulse transmitted to the hypoglossal nerve according to the received stimulation information. The in-vivo device and the in-vitro device form a closed loop regulating circuit of the stimulation pulse between the in-vivo device and the in-vitro device by utilizing the bidirectional communication of the magnetic induction link and the feedback regulation of the stimulation pulse, so that the condition that the stimulation pulse received by a user is harmful to the user or the original stimulation pulse cannot play a good treatment role on the user due to the change of the body state of the user is avoided, and the effectiveness and the reliability of the apnea treatment of the hypoglossal nerve stimulation device are further improved by utilizing the closed loop regulating mode. In addition, the step of performing closed-loop regulation of stimulation pulses according to the electrical stimulation response information may be performed throughout the use process of the sublingual stimulation device, or may be selectively turned on, which is not limited in this embodiment.
In another example, the in vivo device is further configured to sense the voltage and resistance between the stimulation electrodes to obtain an electrical stimulation response. After the in-vivo device sends stimulation pulses to the hypoglossal nerve according to the received energy and stimulation information, the response of a user to the stimulation pulses can change in real time, the presented 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 stimulation electrode and the lower stimulation electrode so as to obtain the excitation degree of the hypoglossal nerve of the user after the stimulation of the stimulation pulses, the voltage value and the resistance value between the upper stimulation electrode and the lower stimulation electrode are used for representing the electrical stimulation response information of the user and transmitting the electrical stimulation response information 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 hypoglossal nerve is stimulated by the adjusted stimulation pulses, the voltage and resistance between the electrodes fall within a predetermined interval. 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 acquired, reliable user response data is provided for subsequent feedback adjustment, and the effectiveness of stimulation pulse treatment is further ensured.
In another example, the in-vivo device adjusts the capacitance value of the second discrete capacitor by way of load-keying modulation. After the in-vivo device detects the electrical stimulation reaction of the hypoglossal nerve of the user to the stimulation pulse, the capacitance access state of the second discrete capacitor is adjusted by using a load keying modulation mode and an in-vivo microcontroller, the capacitance value of the second discrete capacitor is changed, and the information coding of the electrical stimulation reaction is realized. By utilizing the load keying modulation mode, the on-off response time for controlling the change of the capacitance value is greatly reduced, and the detected user electrical stimulation response information is transmitted to the in-vitro device in time. In practical application, a 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 used to replace a switch which needs to be newly added, the C-MOS switch is integrated in an in-vivo integrated circuit, and the on-off state of the C-MOS transistor is controlled by an in-vivo microcontroller, so that the capacitance value adjustment efficiency is ensured, and the volume of the in-vivo device is further reduced.
In another example, the controller modulates the stimulation information by amplitude shift keying modulation or phase shift keying modulation. The external device of the apnea stimulation device comprises a controller integrated with a microcontroller, a modulator, a demodulator and an amplifier, when the apnea stimulation device enters a working state, pulse stimulation parameters transmitted to the hypoglossal nerve according to needs are generated by the microcontroller through the modulator, the stimulation information can be modulated by a stimulation signal to be transmitted in an amplitude shift keying modulation mode or a phase shift keying modulation mode, when the working mode of the modulator is set to be the amplitude shift keying modulation mode, the simplest stimulation signal modulation can be realized, the volume of the controller can be reduced as much as possible, when the working mode of the modulator is set to be the phase shift keying modulation mode, the generated stimulation signal can be transmitted to the internal device with the lowest energy loss, and the overall energy consumption of the external device is reduced, the charging duration of the extracorporeal device is prolonged.
In practical applications, the modulation method used in the communication between the in-vivo device and the in-vitro device may be selected and changed according to actual situations or needs, and the specific modulation method is not limited in this embodiment.
In another example, the apnea stimulation device further comprises: the remote controller is in communication connection with the in-vitro device and is used for receiving the stimulation parameters set by the user and sending the stimulation parameters to the in-vitro device; the extracorporeal device is also used to adjust the stimulation information according to the stimulation parameters. The schematic structure of the apnea apparatus including the remote controller is shown in fig. 6, and includes an in-vivo apparatus 601 for sending stimulation pulses to the hypoglossal nerve and feeding back the electrical stimulation response information of the user; an extracorporeal device 602 for transmitting energy and stimulation information to the extracorporeal device, adjusting the transmitted stimulation information according to an electrical stimulation response of the extracorporeal device; the remote controller 603 is in communication connection with the extracorporeal 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 micro-controller, the micro-control regulator receives the parameter setting of the stimulation pulse sent to the hypoglossal nerve by a user or a doctor, the parameter setting comprises the strength, duration and other parameters of the stimulation pulse, the received stimulation parameter is sent to the extracorporeal device, and the extracorporeal device adjusts the stimulation information required to be sent to the extracorporeal device according to the received stimulation parameter. 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, the situation that the user needs a secondary operation to reset the stimulation pulse after the user generates tolerance to the specific pulse is avoided, and the practicability of the apnea device is improved.
In addition, the breathing sensor can be arranged in the remote controller, the breathing sensor is not arranged in the external device, whether the apnea symptom and the breathing state of the user occur or not is detected through the breathing sensor arranged in the remote controller, when the apnea state of the user is detected and the breathing apnea state is detected, the breathing sensor provides alarm information for the microcontroller, after the microcontroller receives the alarm information, the instruction carrying the stimulation parameter is sent to the external device according to the stimulation parameter set by the user last time or the stimulation parameter pre-stored in advance, the external device is controlled to send energy and stimulation information to the internal device according to the stimulation parameter, and specific electrical stimulation is carried out on the user. Through setting up breathing inductor in the remote controller, reduce the volume that is located the external device of body surface, avoided external device to be in standby state in real time, internal device and external device can be in the off-state when need not send stimulation pulse, only send stimulation pulse 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 external device, the in-vitro device may also transmit the electrical stimulation response information to the remote controller, and the user may adjust the stimulation parameters automatically according to the electrical stimulation response information displayed on the remote controller, or may adjust the stimulation parameters by the microcontroller of the remote controller according to a feedback adjustment mechanism, and send the adjusted stimulation parameters to the in-vitro device, which is not limited in this embodiment. The stimulation pulse is adjusted in a closed-loop control mode, so that the effectiveness of the stimulation pulse is ensured, and the stimulation pulse is prevented from causing harm to a user.
In practical application, the breathing sensor may be disposed outside the body according to actual needs, or disposed in the remote controller, and the specific arrangement manner of the breathing 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 in-vitro 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 connection can be carried out in a data transmission mode by connecting a wireless network, so that the limitation of a connecting line when the connection is carried out in a physical connection mode is avoided; can also be connected with external device by the mode that the bluetooth pairs, avoid local area network to use unable accurate efficient to carry out sublingual nerve stimulation in the limited scene, connect external device and remote controller through multiple possible communication connection mode, guarantee data communication's accuracy and efficiency between the two, further ensure sublingual nerve stimulation device's practicality and reliability.
In addition, it should be understood that the above steps of the various methods are divided for clarity, and the implementation may be combined into one step or split into some steps, and the steps are divided into multiple steps, so long as the same logical relationship is included in the protection scope of the present patent; it is within the scope of the patent to add insignificant modifications to the algorithms or processes or to introduce insignificant design changes to the core design without changing the algorithms or processes.
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples for carrying out the present application, and that various changes in form and details may be made therein without departing from the spirit and scope of the present application in practice.
Claims (10)
1. A sublingual nerve stimulation device, comprising: in vivo devices, in vitro devices;
the in-vivo device is arranged at the far end of the hypoglossal nerve and 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 in-vitro device, the integrated chip is used for generating a stimulation pulse according to the received energy and the stimulation information, and the stimulation electrode is used for transmitting the stimulation pulse to the hypoglossal nerve;
the extracorporeal device is installed on a body surface above the intracorporeal device, the extracorporeal device comprises a coil and a controller, the controller is connected with the coil, the controller 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 intracorporeal device.
2. The sublingual nerve stimulation device of claim 1, further comprising: a remote controller;
the remote controller is in communication connection with the in-vitro device and is used for receiving stimulation parameters set by a user and sending the stimulation parameters to the in-vitro device;
the extracorporeal device is further configured to adjust the stimulation information according to the stimulation parameter.
3. The hypoglossal nerve stimulation device of claim 2, wherein said extracorporeal device and said remote controller are in said communication connection via a data line, a bluetooth or a wireless network.
4. The hypoglossal nerve stimulation device of claim 1, wherein said in vivo device further comprises: a first discrete capacitor and a second discrete capacitor, the first discrete capacitor for forming a resonant circuit with the flexible coil; 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 further used for transmitting the electric stimulation response to the extracorporeal device;
the in-vitro device is also used for receiving the electrical stimulation response, adjusting the sent stimulation information according to the electrical stimulation response and forming a closed loop regulating circuit of the stimulation pulse.
5. The sublingual nerve stimulation device of claim 4, wherein: the in-vivo device is further used for detecting the voltage and the resistance between the stimulation electrodes and obtaining the electric stimulation response.
6. The hypoglossal nerve stimulation device of claim 4, wherein the in-vivo device adjusts the capacitance value of the second discrete capacitance by way of load-keying modulation.
7. The sublingual nerve stimulation device of claim 1, wherein the in-vivo device is integrated on a flexible PCB board, the flexible PCB board being bent into a sleeve shape.
8. The sublingual nerve stimulation device of claim 7, wherein 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 daughter board close to the hypoglossal nerve; the flexible coil is integrated on the second PCB daughter 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 daughter board.
9. The hypoglossal nerve stimulation device of claim 1, wherein said extracorporeal device further comprises: the breathing sensor is connected with the controller and used for detecting the breathing state of the user and sending an apnea alarm to the controller when the user has apnea;
the controller is further configured to send the stimulation signal to the in-vivo device upon receiving the apnea alarm.
10. The hypoglossal nerve stimulation device of any one of claims 1 to 8, wherein the controller performs modulation of the stimulation information by amplitude shift keying modulation or phase shift keying modulation.
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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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| CN202110970411.3A CN113856047B (en) | 2021-08-23 | 2021-08-23 | Hypoglossal nerve stimulation device |
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| CN113856047B (en) | 2023-05-26 |
| WO2023024587A1 (en) | 2023-03-02 |
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