CN106669032B - Snore sleep apnea preventing system capable of being charged rapidly - Google Patents

Snore sleep apnea preventing system capable of being charged rapidly Download PDF

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CN106669032B
CN106669032B CN201611194588.4A CN201611194588A CN106669032B CN 106669032 B CN106669032 B CN 106669032B CN 201611194588 A CN201611194588 A CN 201611194588A CN 106669032 B CN106669032 B CN 106669032B
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processor
upper airway
electrode
stimulator
hypoglossal nerve
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CN106669032A (en
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Beijing Pins Medical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3601Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems
    • A61N1/36135Control systems using physiological parameters
    • A61N1/36139Control systems using physiological parameters with automatic adjustment
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02BCLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO BUILDINGS, e.g. HOUSING, HOUSE APPLIANCES OR RELATED END-USER APPLICATIONS
    • Y02B70/00Technologies for an efficient end-user side electric power management and consumption
    • Y02B70/30Systems integrating technologies related to power network operation and communication or information technologies for improving the carbon footprint of the management of residential or tertiary loads, i.e. smart grids as climate change mitigation technology in the buildings sector, including also the last stages of power distribution and the control, monitoring or operating management systems at local level
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y04INFORMATION OR COMMUNICATION TECHNOLOGIES HAVING AN IMPACT ON OTHER TECHNOLOGY AREAS
    • Y04SSYSTEMS INTEGRATING TECHNOLOGIES RELATED TO POWER NETWORK OPERATION, COMMUNICATION OR INFORMATION TECHNOLOGIES FOR IMPROVING THE ELECTRICAL POWER GENERATION, TRANSMISSION, DISTRIBUTION, MANAGEMENT OR USAGE, i.e. SMART GRIDS
    • Y04S20/00Management or operation of end-user stationary applications or the last stages of power distribution; Controlling, monitoring or operating thereof
    • Y04S20/20End-user application control systems

Abstract

The invention discloses a chargeable snore sleep apnea preventing system, which comprises: the device comprises a hypoglossal nerve stimulator and an upper airway muscle stimulator, wherein the hypoglossal nerve stimulator comprises a first electrode, a first pulse generator, a pressure sensor, a breathing parameter acquisition device, a first temperature sensor, a first charging coil, a first main battery, a first standby battery, a first processor and a first communication module, the first electrode is positioned on the hypoglossal nerve, and the pressure sensor is positioned on intercostal muscles to synchronize the sublingual stimulation pulse with the inspiration action; the upper airway muscle stimulator comprises a second pulse generator, a second processor, a wake-up module, a second electrode, a second communication module, a second charging coil, a second main battery, a second standby battery, a second temperature sensor and a second electrode, wherein the second electrode is positioned at the upper airway muscle; the charging coil and the standby battery charge the main battery, and the temperature sensor is used for monitoring the charging temperature, so that the epileptic sleep apnea preventing system can be safely and quickly charged.

Description

Snore sleep apnea preventing system capable of being charged rapidly
Technical Field
The invention relates to an implantable snore sleep apnea preventing system, in particular to an implantable snore sleep apnea preventing system capable of being charged rapidly.
Background
The loudness of snore after the patient with snore is asleep is increased by more than 60dB, and the gas exchange during normal breathing is hindered, 5% of the patients with snore have the phenomenon of breath holding at different degrees during sleep, namely obstructive sleep apnea syndrome, and the effect of breath holding and even asphyxia can occur.
US8381735B2 discloses an implant under the tongue base that improves snoring but does not prevent asphyxia.
US patent 8517028B2 discloses placement of an implant from the hyoid bone posteriorly towards the posterior surface of the tongue along the posterior wall towards the free end of the patient's soft palate in an area extending upwardly to ameliorate snoring but not prevent asphyxia.
Therefore, the anti-asphyxia complications are prevented while the snoring is relieved, and the rapid charging of the epileptic sleep apnea prevention system is guaranteed to be a technical problem at present.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provide a rechargeable implantable sleep apnea preventing system. The system comprises: the device comprises a hypoglossal nerve stimulator and an upper airway muscle stimulator, wherein the hypoglossal nerve stimulator comprises a first electrode, a first pulse generator, a pressure sensor, a respiratory parameter acquisition device, a first charging coil, a first main battery, a first standby battery, a first temperature sensor, a first processor and a first communication module, the first electrode is positioned on the hypoglossal nerve, and the pressure sensor is positioned on intercostal muscles to synchronize the sublingual stimulation pulse with the inhalation action; the first processor controls the first charging coil to charge the first main battery and the first standby battery; the first processor controls the first standby battery to charge the first main battery; the first temperature sensor measures a first charging temperature of the hypoglossal nerve stimulator;
the upper airway muscle stimulator comprises a second pulse generator, a second processor, a wake-up module, a second electrode, a second communication module, a second charging coil, a second main battery and a second standby battery; the second electrode is positioned at the upper airway muscle; the second processor controls the second charging coil to charge the second main battery and the second standby battery; the second processor controls the second backup battery to charge the second main battery. The second temperature sensor measures a second charging temperature of the upper airway muscle stimulator. Stopping charging the first main battery by the first processor when the first charging temperature exceeds a threshold; when the second charging temperature exceeds a threshold, the second processor stops charging the second main battery.
The first processor controls the first pulse generator to send pulses to the first electrode of the hypoglossal nerve for stimulation according to preset parameters when a patient sleeps, meanwhile, the respiratory parameter acquisition equipment acquires respiratory parameters such as blood oxygen saturation, judges whether the blood oxygen saturation is lower than a choking threshold, and when the blood oxygen saturation is lower than the choking threshold, the first communication module is communicated with the second communication module to activate the awakening module to awaken the upper airway muscle stimulator, and the second processor controls the second pulse generator to send pulses to the second electrode at the upper airway muscle according to the preset parameters; the hypoglossal nerve stimulator stimulates the hypoglossal nerve to relieve snoring symptoms, and when the suffocation occurs, the upper airway muscle stimulator is aroused to stimulate the upper airway muscle, expand the upper airway and prevent the suffocation from occurring.
Further, the system further comprises: and the external early warning controller is used for carrying out early warning on external communication when the upper airway muscle stimulator stimulates that the blood oxygen saturation does not rise to a certain threshold value for a period of time.
Further, when the upper airway muscle stimulator stimulates that the blood oxygen saturation has not risen to a threshold for a period of time, in communication with the hypoglossal nerve stimulator, the first processor sets the pulser parameters to an amplitude that wakes up the patient but is not damaging to the patient, thereby waking up the patient.
Furthermore, the external early warning controller can control pulse parameters of the two stimulator pulse generators.
Further, the first and second primary batteries and the first and second secondary batteries are lithium ion rechargeable batteries or other fast-rechargeable batteries.
The system ensures that the epileptic sleep apnea preventing system is charged safely and quickly.
Drawings
Fig. 1 is a diagram of an implantable sleep apnea preventing system according to the present invention.
101. Hypoglossal nerve stimulator 102. Upper airway muscle stimulator 103. External early warning controller
201. First electrode 202, first pulse generator 203, pressure sensor 204, respiratory parameter acquisition device 205, first processor 206, first communication module
301. Second pulse generator 302, second processor 303, wake-up module 304, second electrode 305, second communication module.
Detailed Description
The invention will be further described with reference to the drawings and examples.
Fig. 1 shows a snoring sleep apnea preventing system, which mainly includes a hypoglossal nerve stimulator 101 and an upper airway muscle stimulator 102. Wherein the hypoglossal nerve stimulation is mainly used for relieving snoring action, and the upper airway muscle stimulator is mainly used for awakening in a choking state.
The sublingual nerve stimulator comprises a first electrode 201 implanted under the tongue, and a needle electrode or an electrode array is usually adopted, wherein the electrodes are implanted into different structures of nerves in the sublingual muscle, and when the electrodes are stimulated, the electrodes can stimulate the hypoglossal nerves, so that the tongue is pushed forward to relieve snoring.
The hypoglossal nerve stimulator further includes an IPG pulse generator module typically implanted in the chest, wherein the IPG module includes a pressure sensor 203, a first pulse generator 202, a respiratory parameter acquisition device 204, a first charging coil, a first main battery, a first backup battery, a first temperature sensor, a first processor 205, and a first communication module 206. The IPG module is connected to the first electrode 201 by wires passing over the neck. The first processor 205 controls the first charging coil to charge the first main battery and the first standby battery; the first processor 205 controls the first backup battery to charge the first main battery; the first temperature sensor measures a first charging temperature of the hypoglossal nerve stimulator 101. When the first charging temperature exceeds a threshold, charging of the first main battery is stopped by the first processor 205.
The pressure sensor 203 is implanted in the intercostal muscle of the right intermediate subclavian region, detects the pressure of the intercostal muscle and sends a signal to the first processor 205 which analyzes the signal to obtain the respiratory cycle and the initial inhalation phase of the respiratory phase and synchronizes the time series of its pulse signals to the first pulse generator 202, which synchronizes the stimulation of the sublingual electrode with the respiratory cycle when the snoring function is activated.
The detection of snoring and apnea can be achieved by breathing parameters, heart rate, related muscle movements, wherein the breathing parameters are the most accurate and easy to achieve monitoring means. Respiratory parameter acquisition device 204 may be implemented using any device integrated device capable of monitoring physical signals and converting the signals into electrical signals, where the monitored parameters may be airway pressure, muscle activity, airway flow rate, blood oxygen saturation, blood osmotic pressure, blood PH, and the like.
One common device is to monitor blood oxygen saturation using a blood oxygen saturation sensor SO2, and a percutaneous blood oxygen detection system may be used. An infrared sensor is taken as an example of a blood oxygen detection system and comprises a light generation and receiving module, wherein the light generation and receiving module emits infrared light or near infrared light with more than 2 wavelengths, the wavelength range generally takes near infrared light wave bands of 500-850nm where absorption peaks of oxyhemoglobin and deoxyhemoglobin are located, absorbance is monitored through a Lambert Law, and the blood oxygen saturation SO2 is calculated through different absorbance coefficients of the two types of hemoglobin. Oxygen sensors and pulse oximetry may also be used to determine blood oxygen levels.
Since the blood sample of the human body varies with arterial pulsation, the blood oxygen saturation R (t) under normal sleep breathing conditions and the blood oxygen saturation Ro (t) under snoring conditions can be manually recorded in advance, values of the time series of the blood oxygen saturation R (t) during normal periods are recorded by dotting or other methods and the average interval with pulsation is calculated, thereby determining the threshold Ro from normal breathing to snoring conditions, and the asphyxia threshold Rr under extreme conditions of snoring is calculated.
There are two modes of use in the snore sleep apnea prevention system, which can be set by the physician, one mode is to turn on both the apnea prevention mode and the snore relieving mode, and the second mode is to turn on only the apnea prevention mode.
Upon turning on the snore function mitigation mode, the first processor 205 processes parameters of the blood oxygen saturation sensor to monitor whether the blood oxygen saturation SO2 continues to be below the snore state threshold Ro. If so, the first processor 205 generates a trigger signal to the first pulse generator 202 and synchronizes the time sequence of the respiratory pulse signal of the pressure sensor 203 for inhaling the gas phase. The first pulse generator 202 generates a pulse signal synchronized with the inspiratory effort and passes up through the lead wire into the neck of the patient to the sublingual first electrode 201. The first electrode 205 is electrically stimulated at the beginning of the inhalation phase to produce a push-forward motion of the tongue that alleviates snoring behavior.
The initial electrical stimulation of the inspiratory phase avoids the hysteresis effect of the upper airway, so that the sublingual motor nerve is stimulated at each spontaneous inhalation, and the lingual muscle fibers are moved, thereby alleviating the snoring behavior. The electric stimulation can be realized by using 10-18v voltage with the stimulation frequency of 30-50hz, and the narrower pulse width is ensured, so that the effect of enough stimulation and no arousal can be achieved.
When only the asphyxia prevention mode is turned on, no decision is made as to the snoring state threshold, i.e., conventional stimulation is not performed through the hypoglossal nerve to delay snoring action, and only the asphyxia state is prevented, which is used in a low-battery state or other situations where it is not appropriate to turn on the snoring relief mode.
Early warning of asphyxia: the first processor 205 monitors the blood oxygen saturation SO2 for a duration below the asphyxia threshold Rr for 10 seconds, or triggers an early warning when one of N times below the asphyxia threshold Rr conditions for 30 seconds, N being settable by the physician, such as setting n= 5,N =10, etc. At this point, it is shown that there is a further risk of asphyxia in the snoring state, requiring stimulation of the upper airway muscles, entering the early warning mode.
The upper airway muscle stimulator 102 is implanted near the airway, preferably in a location near the throat of the airway. Comprises a second electrode 304 for stimulating the upper respiratory muscle, a second pulse generator 301, a second processor 302, a wake-up module 303, a second electrode 304, a second communication module 305, a second charging coil, a second main battery, a second backup battery, a second temperature sensor. The second processor 302 controls the second charging coil to charge the second main battery and the second backup battery; the second processor 302 controls the second backup battery to charge the second main battery. The second temperature sensor measures a second charging temperature of the upper airway muscle stimulator 102. When the second charging temperature exceeds a threshold, charging of the second main battery is stopped by the second processor 302.
The second electrode 304 may also be an implantable needle electrode that is implanted into the upper airway muscle for electrical discharge. Non-invasive flexible electrode patches or other forms of electrodes may also be employed to stimulate muscles. The preset pulse is an electric stimulation pulse group which lasts for 0.1-0.3 seconds, and the preset pulse is repeated for 1-5 times. Specific parameters such as duration, amplitude, number of repetitions of the pulse are set by the physician.
In the early warning mode, the first processor 205 transmits the early warning signal to the first communication module 206, which sends the signal to the second communication module 305. The second communication module and the first communication module preferably have wireless communication units, and can adopt wireless communication protocols such as Bluetooth, zigbee and the like for signal transmission.
The second communication module 305 inputs the early warning signal to the wake-up module 303, so that the second processor 302 is started to control the second pulse generator 301 to send pulses to the second electrode 304 at the upper airway muscle, and the upper airway muscle is directly stimulated by discharging, so that the uvula is stimulated to expand the upper airway, and the asphyxia is prevented.
In another aspect, for a apnea prevention mode trigger, the respiratory rate acquired by the respiratory parameter acquisition device and the pressure sensor may be jointly determined. For example, the parameter R (T) acquired by the blood oxygen saturation sensor and the average respiratory period T of the respiratory pulse acquired by the pressure sensor are calculated by the first processor 205.
At this time, if one of the following conditions is satisfied: r (T) is continuously below the asphyxia threshold Rr for 10 seconds, N times below the asphyxia threshold Rr for 30 seconds, no respiratory activity has been measured for a time greater than M1 x T0, or the measured average period is greater than M2 x T0; t0 is the respiratory cycle measured in good condition;
or triggering the suffocation early warning mode when the condition 1 and the condition 2 are simultaneously met.
Wherein condition 1: either continuously below the asphyxia threshold Rr for X1 seconds or n times below the asphyxia threshold for X2 seconds,
condition 2: no respiratory behaviour has been measured for a time greater than m 1T 0, or the average period measured is greater than one of m 2T 0
Wherein X1<10, 10< X2<30, M1> M1> M2> M2,
in another aspect, the respiratory parameter collection device 205 may be configured to collect a plurality of respiratory parameters, such as a blood oxygen sensor in combination with an airway pressure sensor, and the processor determines whether the user is snoring or if the user is at risk for asphyxia.
Preferably, after the first processor 205 triggers the pre-alarm, it monitors whether the blood oxygen saturation level rises to the threshold R1 or effectively remains above the threshold R2 15 seconds after triggering the pre-alarm. Wherein the threshold value may be set by a physician, preferably the range R1> Ro, R2> Rr. If the above criteria are not met, it is stated that there is no effective risk of contact respiratory block for upper airway muscle stimulation. At this time, the first processor 205 sends a signal to the external early warning controller 103 through the first communication module 206, and starts the wake-up mode. The first communication module 206 and the external body are provided with wireless communication units, and signal transmission is performed through Zigbee or bluetooth.
The external early warning controller 103 comprises a communication module, a control interface, a processor, a switch, a power supply and the like. The communication module is provided with a wireless communication unit, receives a wake-up request transmitted from the first communication module 206, and can transmit control signals to the first communication module 206 and the second communication module 305. The control interface can comprise a key, a knob, a touch screen and other modes, and can set the waveform, the amplitude, the duration and the like of the signal; preferably, the related stimulation signals of the hypoglossal nerve stimulator 101 and the upper airway muscle stimulator 201 to the sublingual muscle and the airway muscle can also be set by the external early warning controller, and the related stimulation signals are not limited to setting the waveform, amplitude, duration of stimulation, repetition number and the like of stimulation. The processor processes the wake-up request and the information of the control interface and sends out corresponding signals through the communication module.
The external early warning controller mainly adopts two working modes:
setting a mode: the physician performs parameter setting on the relevant stimulation signals of the sublingual nerve stimulator 101 and the upper airway muscle stimulator 201 for the sublingual muscle and the airway muscle through the control interface, and is not limited to waveform, amplitude, duration, frequency, pulse width, and the like. The processor sends control signals to the first and second processors via the first and second communication modules 206, 305. Other control functions such as reset, mode selection (such as whether to start the function of relieving snoring symptoms), a switch and the like can be performed through the external early warning controller.
Wake mode: the external early warning controller street sends a control signal to the first communication module 206 and the second communication module 305 simultaneously from the wake-up request external early warning controller transmitted by the first communication module 206, parameters of the first pulse generator and the second pulse generator are respectively set through the first processor and the second processor, and a pulse with larger amplitude is generated through the sublingual electrode and the electrode of the upper respiratory tract muscle, so that a patient is awakened, and the risk of asphyxia is avoided.
Both the hypoglossal nerve stimulator 101 and the upper airway muscle stimulator 201 have power modules that can use lithium batteries, rechargeable batteries, and wireless charging units that can wirelessly charge the stimulator through an in vitro charging module.
The first and second primary batteries and the first and second secondary batteries are lithium ion rechargeable batteries or other rapidly rechargeable batteries.

Claims (5)

1. A rechargeable sleep apnea preventing system comprising a hypoglossal nerve stimulator (101) and an upper airway muscle stimulator (102), characterized by: the hypoglossal nerve stimulator (101) comprises a first electrode (201), a first pulse generator (202), a pressure sensor (203), a respiratory parameter acquisition device (204), a first charging coil, a first main battery, a first standby battery and a first temperature sensor; a first processor (205) and a first communication module (206), the first electrode (201) being located on the hypoglossal nerve, the pressure sensor (203) being located on the intercostal muscle to synchronize the sublingual stimulation pulses with the inspiratory action; the first processor (205) controls the first charging coil to charge the first main battery and the first standby battery; the first processor (205) controls the first backup battery to charge the first main battery; the first temperature sensor measures a first charging temperature of the hypoglossal nerve stimulator (101); the upper airway muscle stimulator (102) comprises a second pulse generator (301), a second processor (302), a wake-up module (303), a second charging coil, a second main battery, a second standby battery, a second temperature sensor, a second electrode (304) and a second communication module (305); the second electrode (304) is located at an upper airway muscle; -the second processor (302) controls the second charging coil to charge the second main battery and the second backup battery; -the second processor (302) controls the second backup battery to charge the second main battery; the second temperature sensor measures a second charging temperature of the upper airway muscle stimulator (102);
the first processor (205) controls the first pulse generator (202) to send pulses to the first electrode (201) of the hypoglossal nerve for stimulation according to preset parameters when the patient sleeps, the respiratory parameter acquisition device (204) acquires respiratory parameter blood oxygen saturation, judges whether the blood oxygen saturation is lower than a suffocation threshold, the first communication module (206) is communicated with the second communication module (305) when the blood oxygen saturation is lower than the suffocation threshold, the wake-up module (303) is activated, the upper airway muscle stimulator (102) is woken up, and the second processor (302) controls the second pulse generator (301) to send pulses to the second electrode (304) at the upper airway muscle according to preset parameters; the hypoglossal nerve stimulator (101) stimulates the hypoglossal nerve to relieve snoring symptoms, and when suffocation is about to occur, the upper airway muscle stimulator (102) is aroused to stimulate upper airway muscles, expand the upper airway and prevent the suffocation from occurring;
when the upper airway muscle stimulator (102) stimulates that blood oxygen saturation has not risen to a certain threshold for a period of time, in communication with the hypoglossal nerve stimulator (101), the first processor (205) sets pulser parameters to an amplitude that can wake up the patient but is not damaging to the patient, thereby waking up the patient.
2. The rechargeable snoring sleep apnea prevention system of claim 1, wherein: stopping charging the first main battery by the first processor (205) when the first charging temperature exceeds a threshold; when the second charging temperature exceeds a threshold, charging of the second main battery is stopped by the second processor (302).
3. The rechargeable snoring sleep apnea prevention system of claim 1, wherein: the prevention system is provided with an in-vitro early warning controller (103), and when the upper airway muscle stimulator (102) stimulates that the blood oxygen saturation does not rise to a certain threshold value for a period of time, early warning is carried out through the in-vitro early warning controller (103).
4. A rechargeable snoring sleep apnea prevention system according to claim 3, wherein: the external early warning controller (103) can control pulse parameters of the first pulse generator (202) and the second pulse generator (301).
5. The rechargeable snoring sleep apnea prevention system of claim 1, wherein: the first and second primary batteries and the first and second backup batteries are lithium ion rechargeable batteries.
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