WO2019012507A1 - Device and method for detecting and monitoring sleep disorders - Google Patents

Device and method for detecting and monitoring sleep disorders Download PDF

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Publication number
WO2019012507A1
WO2019012507A1 PCT/IB2018/055220 IB2018055220W WO2019012507A1 WO 2019012507 A1 WO2019012507 A1 WO 2019012507A1 IB 2018055220 W IB2018055220 W IB 2018055220W WO 2019012507 A1 WO2019012507 A1 WO 2019012507A1
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WO
WIPO (PCT)
Prior art keywords
transducer
sensor
user
time interval
belt
Prior art date
Application number
PCT/IB2018/055220
Other languages
Spanish (es)
French (fr)
Inventor
Humberto de Jesús ECHEVERRI TOBON
Original Assignee
Humberto Echeverri S.A.S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Humberto Echeverri S.A.S filed Critical Humberto Echeverri S.A.S
Publication of WO2019012507A1 publication Critical patent/WO2019012507A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/113Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb occurring during breathing
    • GPHYSICS
    • G08SIGNALLING
    • G08BSIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
    • G08B21/00Alarms responsive to a single specified undesired or abnormal condition and not otherwise provided for
    • G08B21/02Alarms for ensuring the safety of persons
    • G08B21/06Alarms for ensuring the safety of persons indicating a condition of sleep, e.g. anti-dozing alarms

Definitions

  • the present invention relates to devices and methods for detecting, monitoring and correcting sleep disorders and particularly sleep apnea, and more specifically, to a device and methods for detecting, monitoring and correcting a user's sleep disorders.
  • Sleep disorders are problems that are related to sleep. Among the different sleep disorders are sleep apnea, problems falling asleep and staying asleep, excessive sleep and any behavior that goes beyond normal sleep. Apnea is the interruption of periodic breathing for a period of time. In some individuals this suspension of breathing occurs during sleep, this is called sleep apnea and is considered a sleep disorder.
  • US 2006/0276701 discloses a self-contained conditioning device for the treatment of sleep apnea and a method.
  • the self-contained conditioning device disclosed in US 2006/0276701 comprises a mounting device with at least one respiratory sensor, at least one transducer; at least one critical signal electrode and a control unit connected to each sensor and each transducer; where the mounting device is in contact with the user's skin and at least one of the sensors senses the information indicative of the user's breathing and where in addition the control unit transmits an alarm to the user through one of the transducers of according to a variation in the user's respiratory cycle, also transmits a painful pulse by means of the critical signal electrode when the previous alarm has not been attended by the user.
  • the autonomous conditioning method disclosed in US 2006/0276701 which consists of installing the assembly device, with at least one respiratory sensor; at least one transducer; at least one critical signal electrode; the sensor, the transducer and the electrode are electrically connected to a control unit; sensing the breathing cycle; conditioning the patient to maintain the desired breathing cycle using an actuator and negatively rewarding the patient if he fails to maintain the desired breathing cycle.
  • the electrodes must be in contact with the skin having the skin to be prepared with oil to improve the contact of the electrodes which causes discomfort in the patient, in addition the construction material in some users can cause irritation or allergies. In the same way, if a cable is used to connect the electrodes, the user could disconnect them if they are not fixed properly.
  • US 5,381,801 discloses an apparatus for the prevention of snoring comprising a strap with a plurality of pockets installed in its length, at least one vibrator installed in one of the side pockets and another installed in one of the back pockets; and a time switch and pressure switch.
  • the effectiveness of the device depends on the number of switches it has, its effectiveness is very low, it also depends on the rigidity of the surface on which the user is lying, if the rest surface is very soft, it may not activate
  • the pressure sensor the device is very large to be used comfortably and cause other types of sleep disorders. It forces the user to remain in a certain position which is uncomfortable for the user and trigger other problems related to the user's postural hygiene.
  • the state of the art discloses devices for correction of sleep apnea, however, these are uncomfortable for the user, their mobility is questionable, they are subject to a specific position of the user that could trigger other problems even different to sleep disorders such as neck pain, back pain, muscle contractures, limited movement of the neck or back, numbness and tingling in the arms and legs, the appearance of herniated discs, osteoarthritis, among others.
  • the present invention corresponds to a device and a method for the detection, monitoring and correction of sleep disorders, for example, sleep apnea.
  • the device comprises a belt (1) formed by: a central portion (8) with two ends and an inner housing (2); a dorsal left portion (3) to a first end of the central portion (8) and a dorsal right portion (4) to the second end of the central portion (8); a counting unit (6) disposed in the inner housing (2) of the belt (1); a transducer (5) disposed in the left dorsal portion of the belt (1) or in the right dorsal portion of the belt (1) and connected to the counting unit (6); a sensor (7) connected to the counting unit (6) and arranged in a different place to the place where the transducer (5) is disposed; wherein the counting unit (6) receives signals generated by the sensor (7) and controls the transducer (5).
  • the method is implemented in a computing unit and characterized by the steps: step a) establishing by a user, an acceleration reference sensitivity threshold and a magnetic field reference sensitivity threshold and storing it in a memory register; step b) establishing, by a user, a reference sensitivity time interval and storing it in a memory register; step c) establishing by a user a transducer activation time interval and storing it in a memory register; stage d) monitor and record through the computing unit the acceleration delivered by a sensor at a sampling rate; step e) comparing through the counting unit the signal monitored in step d with the threshold of stage a; if the result of the comparison exceeds the thresholds established in step a during the sensitivity time interval of step b, then activate a transducer during the activation time interval established in step c and return to step d. Otherwise go back to stage d.
  • the device optionally has a device and a method in which spatial magnetic and spatial acceleration signals are combined in a hybrid manner and with the implemented method, sleep disorders associated with apnea are detected, monitored and corrected.
  • FIG. 1 shows the belt with an inner housing in its central portion and two ends.
  • FIG. 2 corresponds to a representation the connection of the electronic elements to the computing unit in a block diagram.
  • FIG. 3 shows an electrical connection diagram of the sensor, communication module and storage unit.
  • FIG. 4 teaches a connection scheme of the computing unit and transducer.
  • FIG. 5 shows a connection diagram of a USB socket and a battery charge controller.
  • the present invention corresponds to a device and a method for the detection, monitoring and correction of sleep disorders, for example, sleep apnea.
  • the device comprises: a belt (1) formed by a central portion (8) with two ends and an inner housing (2), a left dorsal portion (3) to a first end of the central portion (8) and a portion right dorsal (4) to the second end of the central portion (8); a counting unit (6) disposed in the inner housing (2) of the belt (1); a transducer (5) disposed in the left dorsal portion of the belt (1) or in the right dorsal portion of the belt (1) and connected to the counting unit (6); a sensor (7) connected to the counting unit (6) and arranged in a different place to the place where the transducer (5) is disposed; wherein the counting unit (6) receives signals generated by the sensor (7) and controls the transducer (5).
  • computing unit is a device that processes data, for example, microcontrollers, microprocessors, dsPICs, FPGAs, CPLDs, ASICs, SoCs, PSoCs, computers, servers, tablets, cell phones, smartphones and combinations of the previous ones.
  • the device of the invention has a belt (1) formed by: a central portion (8) with two ends and an inner housing (2), a dorsal left portion (3) at a first end of the central portion (8) ) and a dorsal right portion (4) to the second end of the central portion (8), these portions house the electronic elements inside them protecting them from external conditions as well as providing mechanical separation of some components like this:
  • a counting unit (6) arranged in the inner housing (2) of the belt (1) as a central element and where the counting unit (6) receives signals generated by the sensor (7) and controls the transducer (5) .
  • the computing unit (6) is connected to a battery charging circuit (15) and the latter is connected to a battery.
  • the transducer (5) arranged in the left dorsal portion of the belt (1) or in the right dorsal portion of the belt (1) and connected to the counting unit (6) is shown.
  • the transducer (5) can optionally be arranged on the inside or the outside of the left back portion (3) of the belt (1) or on the inside or outside of the back right portion (4) of the belt (1).
  • the material of the belt (1) is selected from different materials such as plastic, cardboard, silicone, plastic resins (eg polyester, vinylester, epoxies) reinforced with fibers (eg glass, aramid, carbon, polyester) and combinations of the above.
  • the belt (1) is constructed of a silicone material that is anti-allergic and that can be used by users with an allergic skin condition. It is also a flexible material which facilitates the adjustment to the contour of the abdomen of each user, providing comfort and resistance to wear by bends. Additionally it is resistant to fluids prolonging the useful life of the device of the invention.
  • the belt (1) has a fixing mechanism that connects the outer end (3a) of the dorsal left portion (3) with the outer end of the right dorsal portion (4a).
  • the fixing mechanism can be selected from the group of magnetic fixing mechanisms, hook and loop type closures, machine pin system, radial locking pins, quick release pins, tapes, belts, fastening systems with ratchets, fastening with sailboat and combinations of the above.
  • a computing unit (6) connects to: a sensor (7), a sensor (9), an LED (11), a transducer (5), a communications module (13), a battery charging circuit ( 15), wherein the communications module (13) is connected to an external computing unit (14) and the computing unit (6).
  • the belt (1) alternatively has a transducer (5) that is selected from the group conformed by light emitting mechanisms, LEDs, electro-stimulating devices, heat generators, cold generators, micro-vibrators, vibration generators, piezoelectric devices, speakers, linear actuators, piston-type electromechanical devices and combinations of the above.
  • the computing unit (6) can operate a micro-vibrator since it is a low consumption device and can be embedded in the computing unit (6) to interrupt an event of sleep apnea awakening or without awakening the user.
  • the belt (1) alternately has a transducer (5) disposed in the left back portion of the belt (1) or in the right back portion of the belt (1) and connected to the counting unit (6); with the information provided by the sensor (7) or the sensors (7) and (9) it is determined by a method if the transducer (5) is activated or inactivated to interrupt the sleep disorder event, for example, apnea.
  • a transducer (5) disposed in the left back portion of the belt (1) or in the right back portion of the belt (1) and connected to the counting unit (6); with the information provided by the sensor (7) or the sensors (7) and (9) it is determined by a method if the transducer (5) is activated or inactivated to interrupt the sleep disorder event, for example, apnea.
  • the transducer (5) is alternatively a tactile stimulation device, which transmits vibrations through the belt (1) that is in contact with the user in the abdominal area and particularly the belt (1) is positioned in the abdominal area of the user and in the central portion (8) disposes the sensor (7) on the navel of the user, and the tactile stimulation device is formed by a motor with an eccentric connected to its axis.
  • a tactile stimulation device will be understood as those tactile stimulating devices that transmit low frequency vibrations to several surfaces so that they can be appreciated by the user.
  • a sensor (7) is connected to the counting unit (6) and is arranged in a different place to the place where the transducer (5) is disposed, in this way there is no electromagnetic interference coming from the transducer (5) that induce on the signals of the sensor (7) since the transducer (5) can be an element that generates high electromagnetic interference (ElectroMagnetic Interference, for its acronym in English EMI), such as an electromechanical transducer as a motor with its axis connected to an eccentric, electroacoustic as a speaker, thermoelectric as a Peltier cell, and other equivalents known to a person moderately versed in the subject or combinations of the above.
  • ElectroMagnetic Interference for its acronym in English EMI
  • the transducer (5) can be a vibration generator, with this arrangement of the sensor (7) and the transducer (5), in portions other than the belt (1), it allows the vibrations coming from the transducer (5). ) do not reach the sensor (7) and result in the preservation of integrity in the signals of the sensor (7) that subsequently have to be processed by the computing unit (6), either to activate a transducer (5) or transmit them to an external computing unit (14) by means of a communication module (13).
  • the sensor (7) is selected from the group consisting of electromyogram (EMG), sensors for electrocardiograms, accelerometers, inertial sensors, microphones, magnetic sensors, pressure sensors, electric potential variation sensors, photoelectric, microelectromechanical systems (Microelectromechanic System , by its acronym in English MEMS) and combinations of the above.
  • EMG electromyogram
  • sensors for electrocardiograms accelerometers, inertial sensors, microphones, magnetic sensors, pressure sensors, electric potential variation sensors, photoelectric, microelectromechanical systems (Microelectromechanic System , by its acronym in English MEMS) and combinations of the above.
  • the sensor (7) is a three-axis accelerometer for measuring spatial acceleration.
  • An example of the sensor (7) is an accelerometer with a measuring range between -19.62 m / s 2 to +19.62 m / s 2 with a sensitivity of 0.0024 m / s 2 and an output noise density of maximum 0.001 (m / s).
  • the senor (7) is an accelerometer-magnetometer with three axes to measure spatial acceleration and three axes to measure spatial magnetic field, for a total of six axes in hybrid operation. This allows the method of the present invention to achieve the detection of a sleep apnea event with greater accuracy than if only the measurement of a sensor (7) of only three axes was processed.
  • the sensor (7) is arranged in the inner housing (2) of the belt (1) where the counting unit (6) is also arranged; being physically close to the computing unit (6) is convenient for minimizing electromagnetic susceptibility (Electromagnetic Susceptibility, for its acronym in English EMS), because by reducing the length of the electrical conductors between the sensor (7) and the unit of computation (6) is also reduced area exposed to EMI therefore there is a lower probability that electromagnetic waves traveling through the air are introduced into these electrical conductors and combined with the sensor signal (7) resulting in a lower signal electronic distortion if the distance between the sensor (7) and the counting unit (6) were greater, that is, the integrity of the sensor signal (7) is maintained.
  • electromagnetic susceptibility Electromagnetic Susceptibility, for its acronym in English EMS
  • electronic distortion will be understood as the alteration suffered by the input signal through an electronic circuit to the output.
  • the electronic distortion of a signal causes a difference between the parameters of the transmitted and received signal, such as its amplitude, frequency and phase.
  • the counting unit (6) connects a second sensor (9) and is arranged in a different place to the place where the transducer (5) is arranged.
  • the sensor (7) is a three-axis accelerometer for measuring spatial acceleration
  • the sensor (9) is a three-axis magnetometer for measuring spatial magnetic field, combining the data obtained from the sensor (7) and the sensor ( 9) with the method implemented in the counting unit (6) the user's position can be established exactly, the positions are for example supine position and lateral decubitus position.
  • the sensor (9) is selected from the group consisting of electromyogram (EMG), sensors for electrocardiograms, accelerometers, inertial sensors, microphones, magnetic sensors, pressure sensors, electric potential variation sensors, photoelectric, microelectromechanical systems and combinations of the above .
  • EMG electromyogram
  • the sensor (9) is a MEMS technology sensor with three axes to measure spatial magnetic field with a measurement range between -1200 ⁇ to +1200 ⁇ with a sensitivity of 0.1 ⁇ and noise density (RMS) of 0.85. ⁇ -rms.
  • the belt (1) has an actuating element that is connected to the counting unit (6) and arranged on the central portion (8) with its dome oriented towards the exterior of the inner housing (2) of the belt (1); the actuating element is selected from the group of electrical switches (for example pushbutton, rocker, reed switch, thermomagnetic, magnetic, DIP, Hall effect), membrane pushbutton among other equivalents recognized by a person moderately skilled in the art and combinations.
  • electrical switches for example pushbutton, rocker, reed switch, thermomagnetic, magnetic, DIP, Hall effect
  • the drive element in turn can be in the following configurations SPST (for its acronym in English, Single Pole Single Throw), SPDT (for its acronym in English, Single Pole Double Throw), DPST (for its acronym in English, Double Pole Single Throw), DPDT (for its acronym in English, Double Pole Double Throw) or combinations of these, in addition can be normally open NO (for its acronym in English, Normally Open) or normally closed NO (for its acronym in English, Normally Closed).
  • SPST for its acronym in English, Single Pole Single Throw
  • SPDT for its acronym in English, Single Pole Double Throw
  • DPST for its acronym in English, Double Pole Single Throw
  • DPDT for its acronym in English, Double Pole Double Throw
  • a SPST-NO button for its acronym in English, Normally Open
  • a SPST-NO button for its acronym in English, Normally Open
  • normally closed NO for its acronym in English, Normally Closed
  • the computing unit (6) has a battery charging circuit (15) formed by a USB socket (24) that connects to a battery charge controller (25) and a transistor (26).
  • the battery charge controller (25) is an integrated current and constant voltage battery charging circuit that controls the charging of lithium ion, NiCD, NiMH and lead acid battery types with voltages ranging from 2.7 V to 29 V.
  • the computing unit (6) has a USB socket (24) which is selected from the types of USB socket Type-A, Type-B or Type-C in its mini and micro variants, for electric recharging, programming and data transfer. It is well known by those moderately versed in the art, that the USB interface works at +5 V and its maximum current is 0.5 A for the standard USB 1.1 and USB 2.0 and 0.9 A for the USB 3.0 standard which allows charging of the battery that the belt has (1).
  • data is sent via a USB cable to an external computing unit (14) for further analysis, in one example, this allows the logs of a user's movements to be downloaded and displayed in computer graphics and to check the effectiveness of operation of the device and method of the present invention, in the detection, monitoring and correction of sleep apnea.
  • the control unit (6) is connected to a wireless communication module (13) which is connected to a second external counting unit (14).
  • the wireless communications module (13) is selected from wireless communication technologies such as Bluetooth, Wi-Fi, Zigbee, RF, GPRS, WiMax and other equivalent technologies known to a person of ordinary skill in the art or combinations thereof.
  • the external computing unit (14) is located in a different place than the belt (1) and the computing unit is selected from the list of data processing devices such as: microcontrollers, microprocessors, dsPICs, FPGAs, CPLDs, ASICs , SoCs, PSoCs, computers, servers, tablets, cell phones, smart phones and combinations of the above.
  • data processing devices such as: microcontrollers, microprocessors, dsPICs, FPGAs, CPLDs, ASICs , SoCs, PSoCs, computers, servers, tablets, cell phones, smart phones and combinations of the above.
  • a computing unit (6) that connects to: a transistor (5a) connected to a transducer (5), a high-frequency oscillator (18), a low-frequency oscillator (19), an LED (11), a integrated circuit voltage reference (17), by means of the signals 16a and 16b are connected a storage unit (16) and a sensor (7), by means of the signals (13a) and (13b) is connected the wireless communication module (13), in addition transistors (7a), (13c) and (16c), a USB port (20), a battery case controller (15) are connected.
  • the transducer (5) is activated using a transistor (5a) due to the current capacity that the computing unit (6) can handle.
  • the transistor has an integrated protection diode for protection of currents from the transducer (5), in addition the transducer (5) has a diode and capacitor in parallel for its electrical protection.
  • the voltage reference integrated circuit (17) provides the level of charge of the battery to the counting unit (6).
  • a high frequency oscillator (18) sets the working speed of the counting unit (6).
  • a low frequency oscillator (19) establishes the time marker functionality can be 32,768 kHz, with this specific frequency there are no significant shifts to measure times of the occurrence of sleep apnea, transducer activation time interval (5) , reference sensitivity time interval and set different operating cycles of the computing unit (6);
  • an integrated voltage reference circuit (17) which gives an indicator of the charge level of the battery to the control unit (6);
  • a storage unit (16) preferably, operates to store reference values and different device configuration parameters such as, for example, time interval for sending sensor information (7) through the wireless communication module (13) among others;
  • the transistors (7a), (13c) and (16c) implemented in the example serve to control the switching on or off of the sensor (7), the wireless communication module (13) and the storage unit (16) to decrease the energy consumption and prolong the operating time of the device of the present invention.
  • the storage unit (16) can be an internal register of the counting unit (6) and can also be external to the counting unit (6).
  • the wireless communication module (13) is connected to the computing unit (6) is a Bluetooth technology module. Therefore, information can be sent to an external computing unit (14), in which information supplied by the sensors (7) and (9) is displayed.
  • the battery is selected from the group of rechargeable lithium-ion batteries, for example, LFP batteries, NMC batteries, Li-S batteries, LiPo batteries and other equivalent batteries known to a person of ordinary skill in the art, lead acid batteries , advanced lead acid batteries, NiMH metal hydride batteries, nickel cadmium (NiCd) batteries, zinc bromide batteries, nickel / chlorine NaNiCl batteries, zinc air batteries, vanadium redox batteries, other equivalent batteries known for a person moderately versed in the subject or combinations of the previous ones.
  • LFP batteries lithium-ion batteries
  • NMC batteries Li-S batteries
  • LiPo batteries Li batteries
  • lead acid batteries advanced lead acid batteries
  • NiMH metal hydride batteries NiMH metal hydride batteries
  • nickel cadmium (NiCd) batteries zinc bromide batteries
  • nickel / chlorine NaNiCl batteries zinc air batteries
  • vanadium redox batteries other equivalent batteries known for a person moderately versed in the subject or combinations of the previous ones.
  • the device is connected to a lithium-ion battery of 3.7 V 1000 mA / h, with this battery the device of the invention can be operated during the course of the user's sleep disconnected from a wired external source, allowing the user comfort before being connected for electric recharging.
  • the method is implemented in a computing unit (6) and characterized by the steps: a. set by a user, an acceleration reference sensitivity threshold and a magnetic field reference sensitivity threshold and store it in a memory register; b. set by a user, a range of reference sensitivity time and store it in a memory register; c. establish by a user a transducer activation time interval and store it in a memory register; d. monitor and record through the computer unit the acceleration delivered by a sensor at a sampling rate; and.
  • a sensitivity threshold reference acceleration ranging from ranges from set - 19.62 m / s 2 to +19.62 m / s 2, this sensitivity range Acceleration contains widely the maximum and minimum ranges for the detection of an episode of sleep apnea.
  • a minimum ranging from -0.0024 m / s 2 to +0.0024 m / s 2 and a maximum sensitivity ranging from -19.62 m / s 2 to + 19.62 m / s 2 can be established .
  • step a the magnetic reference sensitivity threshold is established, which ranges from -1200 ⁇ to +1200 ⁇ , this magnetic sensitivity range contains the maximum and minimum ranges to determine the position of the user.
  • step a sensitivity threshold reference acceleration ranging from -19.62 m / s 2 to +19.62 m / s 2 and the magnetic sensitivity threshold was fixed ranging from -1200 ⁇ to +1200 ⁇ , these ranges of sensitivity of acceleration and magnetic sensitivity widely contain the maximum and minimum ranges for the detection of an episode of sleep apnea and determine the position of the user respectively.
  • a minimum can be established that goes from -0.0024 m / s 2 up to +0.0024 m / s 2 and a maximum sensitivity ranging from - 19.62 m / s 2 to + 19.62 m / s 2 and for magnetic sensitivity a minimum can be established that goes from -1200 ⁇ to + 1200 ⁇ and in one example, in step e, the method combines the measurements of an acceleration sensor (7) with the measurements of a second sensor (9) magnetometer to work in a hybrid manner, giving a more accurate operation than if will use only the three-axis signal from one of the sensors. Redundancy allows to increase the accuracy in the spatial location of the subject.
  • step b a user establishes a second reference sensitivity time interval and stores it in a memory register and in step c a user establishes a second activation time interval of transducer and storing it in a memory register, in step e, comparing the signal monitored in step d with the thresholds of stage a; if the result of the comparison exceeds the thresholds established in step a during the second sensitivity time interval of step b, then activate a transducer during the second activation time interval established in step c, return to step d, if no acceleration is recorded during a second activation interval, then activate the transducer again during the second activation time interval established in step c.
  • the second sensitivity range established by a user in step b is less than the first sensitivity range established by a user in step b and in this way in an example of the method of the present invention periodic activations of the transducer are made if there is a sleep apnea event and the interruption of the initial sleep apnea was not effective, thus increasing the effectiveness of the device to interrupt the sleep apnea.
  • step d the orientation of the axes of a sensor (7) and a second sensor (9) is recorded, in an example of the present invention, this continuous recording in memory the movements of the user serve to determine the position of the user's body with respect to a global reference frame, and positions of the user can be classified for example, supine decubitus and lateral decubitus. This information allows to correlate the appearance of apnea events versus nocturnal postural habits of the user.
  • the first sensitivity time interval goes from 6 seconds to 12 seconds, in a example of the invention, and in this way a wide range is allowed to adjust the time in which a detection of sleep apnea status is valid for a particular user since this value varies from user to user.
  • the first time interval of activation of the transducer goes from 1 second to 5 seconds, for example, user with a high sensitivity to certain external stimuli, to name one , vibrations, will require setting a short transducer activation time while other users less sensitive to vibrations will require a longer activation time of the transducer.

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Abstract

The present invention relates to a device and method for detecting, monitoring and correcting sleep disorders such as sleep apnoea. The device comprises: a belt formed by a central portion with two ends and an inner casing, a left dorsal portion at a first end of the central portion and a right dorsal portion at the other end of the central portion; a computer unit disposed in the inner casing of the belt; a transducer disposed in the left dorsal portion of the belt or in the right dorsal portion of the belt, and connected to the computer unit; and a sensor connected to the computer unit and disposed in a place different from where the transducer is disposed. The method is carried out in the computer unit and is characterised by the following steps: a. establishing, by a user, an acceleration sensitivity threshold of reference and a magnetic-field sensitivity threshold of reference and storing same in a memory record; b. establishing, by a user, a sensitivity time interval of reference and storing same in a memory record; c. establishing, by a user, a transducer-activation time interval and storing same in a memory record; d. monitoring and recording, by means of the computer unit, the acceleration delivered by a sensor at a sampling rate; and e. comparing, by means of the computer unit, the signal monitored in step d using the threshold from step a. If the comparison result exceeds the thresholds established in step a for the sensitivity time interval of step b, the transducer is activated for the activation time interval established in step c, and step d is repeated; if not, step d is repeated.

Description

DISPOSITIVO Y MÉTODO PARA DETECTAR. MONITOREAR  DEVICE AND METHOD TO DETECT. MONITOR
TRASTORNOS DEL SUEÑO  SLEEP DISORDERS
Campo de la invención Field of the invention
La presente invención está relacionada con dispositivos y métodos para detección, monitoreo y corrección de trastornos del sueño y particularmente apnea del sueño, y más específicamente, a un dispositivo y métodos para detectar, monitorear y corregir trastornos del sueño de un usuario. The present invention relates to devices and methods for detecting, monitoring and correcting sleep disorders and particularly sleep apnea, and more specifically, to a device and methods for detecting, monitoring and correcting a user's sleep disorders.
Descripción del estado de la técnica Description of the state of the art
Los trastornos del sueño son problemas que se encuentran relacionados con dormir. Entre los diferentes trastornos del sueño están, la apnea del sueño, problemas para conciliar el sueño y permanecer dormido, exceso de sueño y cualquier conducta que se salga de la normalidad del sueño. La apnea es la interrupción de la respiración periódica por un intervalo de tiempo. En algunos individuos esta suspensión de la respiración ocurre durante el sueño, a esto se le da el nombre de apnea del sueño y es considerado un trastorno del sueño. Sleep disorders are problems that are related to sleep. Among the different sleep disorders are sleep apnea, problems falling asleep and staying asleep, excessive sleep and any behavior that goes beyond normal sleep. Apnea is the interruption of periodic breathing for a period of time. In some individuals this suspension of breathing occurs during sleep, this is called sleep apnea and is considered a sleep disorder.
Para tratar la apnea durante el sueño el estado del arte reporta el uso de máscaras que suministran presión positiva continua en vías respiratorias (Continuous Positive Airway Pressure, por sus siglas en inglés CPAP) que con uso de una máscara conectada por medio de una manguera a un sistema de suministro de aire previene la ocurrencia de la apnea del sueño. Otros dispositivos descritos en el estado del arte proponen un acercamiento distinto para el tratamiento de la apnea del sueño o evitar el ronquido como, por ejemplo, los divulgados en los documentos US 2006/0276701 Al y US 5,381,201. To treat apnea during sleep, the state of the art reports the use of masks that provide continuous positive pressure in the respiratory tract (Continuous Positive Airway Pressure, by its acronym in English CPAP) that with the use of a mask connected by means of a hose to An air supply system prevents the occurrence of sleep apnea. Other devices described in the state of the art propose a different approach for the treatment of sleep apnea or avoid snoring, as, for example, those disclosed in US 2006/0276701 Al and US 5,381,201.
El documento US 2006/0276701 divulga un dispositivo acondicionador autónomo para el tratamiento de apnea del sueño y un método. El dispositivo acondicionador autónomo divulgado en US 2006/0276701 comprende un dispositivo de montaje con al menos un sensor respiratorio, al menos un transductor; al menos un electrodo de señal crítica y una unidad de control conectada a cada sensor y cada transductor; donde el dispositivo de montaje se encuentra en contacto con la piel del usuario y al menos uno de los sensores sensa la información indicativa de la respiración del usuario y donde además la unidad de control trasmite una alarma al usuario a través de uno de los transductores de acuerdo a una variación en el ciclo respiratorio del usuario, asimismo trasmite un pulso doloroso por medio del electrodo de señal crítica cuando la alarma anterior no haya sido atendida por el usuario. El método de acondicionamiento autónomo divulgado en US 2006/0276701 que consiste en instalar el dispositivo de montaje, con al menos un sensor respiratorio; al menos un transductor; al menos un electrodo de señal crítica; el sensor, el transductor y el electrodo se encuentran conectados eléctricamente a una unidad de control; sensar el ciclo de respiración; acondicionar el paciente para mantener el ciclo de respiración deseado haciendo uso de un actuador y recompensado negativamente al paciente si no logra mantener el ciclo de respiración deseado. Los electrodos deben estar en contacto con la piel teniendo la piel que ser preparada con aceite para mejorar el contacto de los electrodos lo que ocasiona molestias en el paciente, además el material de construcción en algunos usuarios puede causar irritación o alergias. Del mismo modo si se hace uso de un cable para conectar los electrodos el usuario podría desconectarlos si no se fijan adecuadamente. El documento US 5,381,801 divulga un aparato para la prevención de ronquido que comprende una correa con una pluralidad de bolsillos instalados en su longitud, por lo menos un vibrador instalado en alguno de los bolsillos laterales y otro instalado en alguno de los bolsillos dorsales; y un switch temporizado y conmutado por presión. La efectividad del aparato depende de la cantidad switches que tenga, su efectividad es muy baja, además depende a su vez que la rigidez de la superficie en la que se encuentra acostado el usuario, si la superficie de descanso es muy suave, puede no activarse el sensor de presión, el dispositivo es muy grande para ser utilizado con comodidad y causar otro tipo de trastornos del sueño. Obliga al usuario a permanecer en cierta posición lo que resulta incómodo para el usuario y desencadenar otros problemas relacionado con la higiene postural del usuario. US 2006/0276701 discloses a self-contained conditioning device for the treatment of sleep apnea and a method. The self-contained conditioning device disclosed in US 2006/0276701 comprises a mounting device with at least one respiratory sensor, at least one transducer; at least one critical signal electrode and a control unit connected to each sensor and each transducer; where the mounting device is in contact with the user's skin and at least one of the sensors senses the information indicative of the user's breathing and where in addition the control unit transmits an alarm to the user through one of the transducers of according to a variation in the user's respiratory cycle, also transmits a painful pulse by means of the critical signal electrode when the previous alarm has not been attended by the user. The autonomous conditioning method disclosed in US 2006/0276701 which consists of installing the assembly device, with at least one respiratory sensor; at least one transducer; at least one critical signal electrode; the sensor, the transducer and the electrode are electrically connected to a control unit; sensing the breathing cycle; conditioning the patient to maintain the desired breathing cycle using an actuator and negatively rewarding the patient if he fails to maintain the desired breathing cycle. The electrodes must be in contact with the skin having the skin to be prepared with oil to improve the contact of the electrodes which causes discomfort in the patient, in addition the construction material in some users can cause irritation or allergies. In the same way, if a cable is used to connect the electrodes, the user could disconnect them if they are not fixed properly. US 5,381,801 discloses an apparatus for the prevention of snoring comprising a strap with a plurality of pockets installed in its length, at least one vibrator installed in one of the side pockets and another installed in one of the back pockets; and a time switch and pressure switch. The effectiveness of the device depends on the number of switches it has, its effectiveness is very low, it also depends on the rigidity of the surface on which the user is lying, if the rest surface is very soft, it may not activate The pressure sensor, the device is very large to be used comfortably and cause other types of sleep disorders. It forces the user to remain in a certain position which is uncomfortable for the user and trigger other problems related to the user's postural hygiene.
Así las cosas, el estado de la técnica divulga dispositivos para corrección de la apnea del sueño, sin embargo, estos son incómodos para el usuario, su movilidad es cuestionable, están sujetos a una posición específica del usuario que podría desencadenar otros problemas incluso diferentes a trastornos del sueño como por ejemplo, dolores de cuello, dolor de espalda, contracturas musculares, limitación en movimiento del cuello o espalda, adormecimientos y hormigueos en brazos y piernas, aparición de hernias discales, artrosis, entre otros. Breve descripción de la invención Thus, the state of the art discloses devices for correction of sleep apnea, however, these are uncomfortable for the user, their mobility is questionable, they are subject to a specific position of the user that could trigger other problems even different to sleep disorders such as neck pain, back pain, muscle contractures, limited movement of the neck or back, numbness and tingling in the arms and legs, the appearance of herniated discs, osteoarthritis, among others. BRIEF DESCRIPTION OF THE INVENTION
La presente invención corresponde a un dispositivo y un método para la detección, monitoreo y corrección de trastornos del sueño, por ejemplo, apnea del sueño. El dispositivo comprende un cinturón (1) conformado por: una porción central (8) con dos extremos y un alojamiento interior (2); una porción izquierda dorsal (3) a un primer extremo de la porción central (8) y una porción derecha dorsal (4) al segundo extremo de la porción central (8); una unidad de cómputo (6) dispuesta en el alojamiento interior (2) del cinturón (1); un transductor (5) dispuesto en la porción izquierda dorsal del cinturón (1) o en la porción derecha dorsal del cinturón (1) y conectado a la unidad de cómputo (6); un sensor (7) conectado a la unidad de cómputo (6) y dispuesto en un lugar diferente al lugar donde está dispuesto el transductor (5); donde la unidad de cómputo (6) recibe señales generadas por el sensor (7) y controla el transductor (5). The present invention corresponds to a device and a method for the detection, monitoring and correction of sleep disorders, for example, sleep apnea. The device comprises a belt (1) formed by: a central portion (8) with two ends and an inner housing (2); a dorsal left portion (3) to a first end of the central portion (8) and a dorsal right portion (4) to the second end of the central portion (8); a counting unit (6) disposed in the inner housing (2) of the belt (1); a transducer (5) disposed in the left dorsal portion of the belt (1) or in the right dorsal portion of the belt (1) and connected to the counting unit (6); a sensor (7) connected to the counting unit (6) and arranged in a different place to the place where the transducer (5) is disposed; wherein the counting unit (6) receives signals generated by the sensor (7) and controls the transducer (5).
El método es implementado en una unidad de cómputo y caracterizado por las etapas: etapa a) establecer por un usuario, un umbral de sensibilidad de referencia de aceleración y un umbral de sensibilidad de referencia de campo magnético y almacenarlo en un registro de memoria; etapa b) establecer por un usuario, un intervalo tiempo de sensibilidad de referencia y almacenarlo en un registro de memoria; etapa c) establecer por un usuario un intervalo tiempo de activación de transductor y almacenarlo en un registro de memoria; etapa d) monitorear y registrar mediante la unidad de cómputo la aceleración entregada por un sensor a una tasa de muestreo; etapa e) comparar mediante la unidad de cómputo la señal monitoreada en la etapa d con el umbral de la etapa a; si el resultado de la comparación sobrepasa los umbrales establecidos en la etapa a durante el intervalo de tiempo de sensibilidad de la etapa b, entonces activar un transductor durante el intervalo de tiempo de activación establecido en la etapa c y volver a la etapa d. En caso contrario volver a etapa d. The method is implemented in a computing unit and characterized by the steps: step a) establishing by a user, an acceleration reference sensitivity threshold and a magnetic field reference sensitivity threshold and storing it in a memory register; step b) establishing, by a user, a reference sensitivity time interval and storing it in a memory register; step c) establishing by a user a transducer activation time interval and storing it in a memory register; stage d) monitor and record through the computing unit the acceleration delivered by a sensor at a sampling rate; step e) comparing through the counting unit the signal monitored in step d with the threshold of stage a; if the result of the comparison exceeds the thresholds established in step a during the sensitivity time interval of step b, then activate a transducer during the activation time interval established in step c and return to step d. Otherwise go back to stage d.
El dispositivo cuenta opcionalmente con un dispositivo y un método en el que se combinan señales de campo magnético espacial y de aceleración espacial de forma híbrida y con el método implementado se detecta, monitorea y corrige trastornos del sueño asociados a la apnea. Breve descripción de las figuras The device optionally has a device and a method in which spatial magnetic and spatial acceleration signals are combined in a hybrid manner and with the implemented method, sleep disorders associated with apnea are detected, monitored and corrected. Brief description of the figures
La FIG. 1 enseña el cinturón con un alojamiento interior en su porción central y dos extremos. FIG. 1 shows the belt with an inner housing in its central portion and two ends.
La FIG. 2 corresponde a una representación la conexión de los elementos electrónicos a la unidad de cómputo en un diagrama de bloques. FIG. 2 corresponds to a representation the connection of the electronic elements to the computing unit in a block diagram.
La FIG. 3 enseña un esquema de conexión eléctrica del sensor, módulo de comunicaciones y unidad de almacenamiento. FIG. 3 shows an electrical connection diagram of the sensor, communication module and storage unit.
La FIG. 4 enseña un esquema de conexión de la unidad de cómputo y transductor. FIG. 4 teaches a connection scheme of the computing unit and transducer.
La FIG. 5 enseña un esquema de conexión de un socket USB y un controlador de carga de baterías. FIG. 5 shows a connection diagram of a USB socket and a battery charge controller.
Descripción detallada Detailed description
La presente invención corresponde a un dispositivo y un método para la detección, monitoreo y corrección de trastornos del sueño, por ejemplo, apnea del sueño. The present invention corresponds to a device and a method for the detection, monitoring and correction of sleep disorders, for example, sleep apnea.
Haciendo referencia a la FIG. 1 y FIG. 2 el dispositivo comprende: un cinturón (1) conformado por una porción central (8) con dos extremos y un alojamiento interior (2), una porción izquierda dorsal (3) a un primer extremo de la porción central (8) y una porción derecha dorsal (4) al segundo extremo de la porción central (8); una unidad de cómputo (6) dispuesta en el alojamiento interior (2) del cinturón (1); un transductor (5) dispuesto en la porción izquierda dorsal del cinturón (1) o en la porción derecha dorsal del cinturón (1) y conectado a la unidad de cómputo (6); un sensor (7) conectado a la unidad de cómputo (6) y dispuesto en un lugar diferente al lugar donde está dispuesto el transductor (5); donde la unidad de cómputo (6) recibe señales generadas por el sensor (7) y controla el transductor (5). With reference to FIG. 1 and FIG. 2 the device comprises: a belt (1) formed by a central portion (8) with two ends and an inner housing (2), a left dorsal portion (3) to a first end of the central portion (8) and a portion right dorsal (4) to the second end of the central portion (8); a counting unit (6) disposed in the inner housing (2) of the belt (1); a transducer (5) disposed in the left dorsal portion of the belt (1) or in the right dorsal portion of the belt (1) and connected to the counting unit (6); a sensor (7) connected to the counting unit (6) and arranged in a different place to the place where the transducer (5) is disposed; wherein the counting unit (6) receives signals generated by the sensor (7) and controls the transducer (5).
Se entenderá que para la siguiente invención que unidad de cómputo es un dispositivo que procesa datos, por ejemplo, microcontroladores, micro procesadores, dsPICs, FPGAs, CPLDs, ASICs, SoCs, PSoCs, computadores, servidores, tabletas, celulares, celulares inteligentes y combinaciones de los anteriores. En referencia a la FIG. 1, el dispositivo de la invención tiene un cinturón (1) conformado por: una porción central (8) con dos extremos y un alojamiento interior (2), una porción izquierda dorsal (3) a un primer extremo de la porción central (8) y una porción derecha dorsal (4) al segundo extremo de la porción central (8), estas porciones alojan los elementos electrónicos en su interior protegiéndolos de las condiciones externas además de proveer separación mecánica de algunos componentes así: It will be understood that for the following invention that computing unit is a device that processes data, for example, microcontrollers, microprocessors, dsPICs, FPGAs, CPLDs, ASICs, SoCs, PSoCs, computers, servers, tablets, cell phones, smartphones and combinations of the previous ones. With reference to FIG. 1, the device of the invention has a belt (1) formed by: a central portion (8) with two ends and an inner housing (2), a dorsal left portion (3) at a first end of the central portion (8) ) and a dorsal right portion (4) to the second end of the central portion (8), these portions house the electronic elements inside them protecting them from external conditions as well as providing mechanical separation of some components like this:
Haciendo referencia a las FIG. 1 y FIG. 2, una unidad de cómputo (6) dispuesta en el alojamiento interior (2) del cinturón (1) como elemento central y donde la unidad de cómputo (6) recibe señales generadas por el sensor (7) y controla el transductor (5). A su vez la unidad de cómputo (6) se conecta a un circuito de carga de baterías (15) y este último se conecta a una batería. With reference to FIGs. 1 and FIG. 2, a counting unit (6) arranged in the inner housing (2) of the belt (1) as a central element and where the counting unit (6) receives signals generated by the sensor (7) and controls the transducer (5) . In turn, the computing unit (6) is connected to a battery charging circuit (15) and the latter is connected to a battery.
Haciendo referencia a las FIG. 1 y FIG. 2, se muestra el transductor (5) dispuesto en la porción izquierda dorsal del cinturón (1) o en la porción derecha dorsal del cinturón (1) y conectado a la unidad de cómputo (6). El transductor (5) puede opcionalmente disponerse en el interior o el exterior de porción izquierda dorsal (3) del cinturón (1) o en el interior o el exterior de la porción derecha dorsal (4) del cinturón (1). With reference to FIGs. 1 and FIG. 2, the transducer (5) arranged in the left dorsal portion of the belt (1) or in the right dorsal portion of the belt (1) and connected to the counting unit (6) is shown. The transducer (5) can optionally be arranged on the inside or the outside of the left back portion (3) of the belt (1) or on the inside or outside of the back right portion (4) of the belt (1).
El material del cinturón (1) se selecciona de diferentes materiales como por ejemplo, plástico, cartón, silicona, resinas plásticas (v.gr. poliéster, viniléster, epóxicas) reforzadas con fibras (v.gr. de vidrio, aramida, carbono, poliéster) y combinaciones de los anteriores. Preferiblemente, el cinturón (1) se encuentra construido con un material siliconado que es anti alérgico y que permite ser utilizado por usuarios con alguna afección alérgica en la piel. Además es un material flexible lo que facilita el ajuste al contorno del abdomen de cada usuario, brindando comodidad y resistencia al desgaste por dobleces. Adicionalmente es resistente a fluidos prolongando la vida útil del dispositivo de la invención. The material of the belt (1) is selected from different materials such as plastic, cardboard, silicone, plastic resins (eg polyester, vinylester, epoxies) reinforced with fibers (eg glass, aramid, carbon, polyester) and combinations of the above. Preferably, the belt (1) is constructed of a silicone material that is anti-allergic and that can be used by users with an allergic skin condition. It is also a flexible material which facilitates the adjustment to the contour of the abdomen of each user, providing comfort and resistance to wear by bends. Additionally it is resistant to fluids prolonging the useful life of the device of the invention.
Haciendo referencia a la FIG. 1, el cinturón (1) tiene un mecanismo de fijación que conecta el extremo exterior (3a) de la porción izquierda dorsal (3) con el extremo exterior de la porción derecha dorsal (4a). El mecanismo de fijación puede ser seleccionado del grupo de mecanismos de fijación magnético, cierres del tipo gancho y bucle, sistema de pasadores de máquina, pasadores de fijación radial, pasadores de liberación rápida, cintas, correas, sistemas de sujeción con trinquetes, sujeción con velero y combinaciones de los anteriores. With reference to FIG. 1, the belt (1) has a fixing mechanism that connects the outer end (3a) of the dorsal left portion (3) with the outer end of the right dorsal portion (4a). The fixing mechanism can be selected from the group of magnetic fixing mechanisms, hook and loop type closures, machine pin system, radial locking pins, quick release pins, tapes, belts, fastening systems with ratchets, fastening with sailboat and combinations of the above.
Haciendo referencia a la FIG. 2, una unidad de cómputo (6) conecta a: un sensor (7), un sensor (9), un LED (11), un transductor (5), un módulo de comunicaciones (13), circuito de carga de baterías (15), donde el módulo de comunicaciones (13) se conecta a una unidad de cómputo externa (14) y la unidad de cómputo (6). With reference to FIG. 2, a computing unit (6) connects to: a sensor (7), a sensor (9), an LED (11), a transducer (5), a communications module (13), a battery charging circuit ( 15), wherein the communications module (13) is connected to an external computing unit (14) and the computing unit (6).
Adicionalmente, el cinturón (1) alternativamente cuenta con un transductor (5) que se selecciona del grupo conformado por mecanismos emisores de luz, LEDs, dispositivos electro-estimuladores, generadores de calor, generadores de frío, micro-vibradores, generadores de vibración, dispositivos piezoeléctricos, parlantes, actuadores lineales, dispositivos electromecánicos tipo pistón y combinaciones de los anteriores. La unidad de cómputo (6) puede operar un micro-vibrador ya que es un dispositivo de bajo consumo y puede ser embebido en la unidad de cómputo (6) para interrumpir un evento de apnea del sueño despertando o sin despertar al usuario. El cinturón (1) tiene alternativamente un transductor (5) dispuesto en la porción izquierda dorsal del cinturón (1) o en la porción derecha dorsal del cinturón (1) y conectado a la unidad de cómputo (6); con la información suministrada por el sensor (7) o los sensores (7) y (9) se determina mediante un método si se activa o inactiva el transductor (5) para interrumpir el evento de trastorno del sueño por ejemplo, apnea. En referencia a la FIG. 2, el transductor (5) alternativamente es un dispositivo de estimulación táctil, que transmite vibraciones a través del cinturón (1) que se encuentra en contacto con el usuario en la zona abdominal y particularmente el cinturón (1) se posiciona en la zona abdominal del usuario y en la porción central (8) dispone el sensor (7) sobre el ombligo del usuario, y el dispositivo de estimulación táctil está conformado por un motor con una excéntrica conectada a su eje. Additionally, the belt (1) alternatively has a transducer (5) that is selected from the group conformed by light emitting mechanisms, LEDs, electro-stimulating devices, heat generators, cold generators, micro-vibrators, vibration generators, piezoelectric devices, speakers, linear actuators, piston-type electromechanical devices and combinations of the above. The computing unit (6) can operate a micro-vibrator since it is a low consumption device and can be embedded in the computing unit (6) to interrupt an event of sleep apnea awakening or without awakening the user. The belt (1) alternately has a transducer (5) disposed in the left back portion of the belt (1) or in the right back portion of the belt (1) and connected to the counting unit (6); with the information provided by the sensor (7) or the sensors (7) and (9) it is determined by a method if the transducer (5) is activated or inactivated to interrupt the sleep disorder event, for example, apnea. With reference to FIG. 2, the transducer (5) is alternatively a tactile stimulation device, which transmits vibrations through the belt (1) that is in contact with the user in the abdominal area and particularly the belt (1) is positioned in the abdominal area of the user and in the central portion (8) disposes the sensor (7) on the navel of the user, and the tactile stimulation device is formed by a motor with an eccentric connected to its axis.
Para el entendimiento de la presente invención se entenderá por dispositivo de estimulación táctil aquellos dispositivos estimuladores táctiles que transmiten vibraciones de bajas frecuencias a varias superficies para que estas puedan ser apreciadas por el usuario. Haciendo referencia a las FIG. 1 y FIG. 2, un sensor (7) se conecta a la unidad de cómputo (6) y se dispone en un lugar diferente al lugar donde está dispuesto el transductor (5), de esta manera no hay interferencia electromagnética que provenga del transductor (5) que se induzcan sobre las señales del sensor (7) ya que el transductor (5) puede ser un elemento que genere alta interferencia electromagnética (ElectroMagnetic Interference, por sus siglas en inglés EMI), como por ejemplo un transductor electromecánico como un motor con su eje conectado a una excéntrica, electroacústico cómo un parlante, termoeléctrico cómo una celda Peltier, y otros equivalentes conocidas por una persona medianamente versada en la materia o combinaciones de las anteriores. También, debido a que el transductor (5) puede ser un generador de vibraciones, con esta disposición del sensor (7) y el transductor (5), en porciones distintas del cinturón (1), permite que las vibraciones provenientes del transductor (5) no lleguen al sensor (7) y resulte en la conservación de la integridad en las señales del sensor (7) que posteriormente tienen que ser procesadas por la unidad de cómputo (6), ya sea para activar un transductor (5) o trasmitirlas a una unidad de computo externa (14) mediante un módulo de comunicaciones (13). For the understanding of the present invention, a tactile stimulation device will be understood as those tactile stimulating devices that transmit low frequency vibrations to several surfaces so that they can be appreciated by the user. With reference to FIGs. 1 and FIG. 2, a sensor (7) is connected to the counting unit (6) and is arranged in a different place to the place where the transducer (5) is disposed, in this way there is no electromagnetic interference coming from the transducer (5) that induce on the signals of the sensor (7) since the transducer (5) can be an element that generates high electromagnetic interference (ElectroMagnetic Interference, for its acronym in English EMI), such as an electromechanical transducer as a motor with its axis connected to an eccentric, electroacoustic as a speaker, thermoelectric as a Peltier cell, and other equivalents known to a person moderately versed in the subject or combinations of the above. Also, because the transducer (5) can be a vibration generator, with this arrangement of the sensor (7) and the transducer (5), in portions other than the belt (1), it allows the vibrations coming from the transducer (5). ) do not reach the sensor (7) and result in the preservation of integrity in the signals of the sensor (7) that subsequently have to be processed by the computing unit (6), either to activate a transducer (5) or transmit them to an external computing unit (14) by means of a communication module (13).
Alternativamente, el sensor (7) se selecciona del grupo conformado por electromiograma (EMG), sensores para electrocardiogramas, acelerómetros, sensores inerciales, micrófonos, sensores magnéticos, sensores de presión, sensores de variación de potencial eléctrico, fotoeléctricos, sistemas microelectromecánicos (Microelectromechanic System, por sus siglas en inglés MEMS) y combinaciones de los anteriores. Preferiblemente, el sensor (7) es un acelerómetro de tres ejes para medir aceleración espacial. Un ejemplo del sensor (7) es un acelerómetro con un rango de medición entre -19.62 m/s2 hasta +19.62 m/s2 con una sensibilidad de 0.0024 m/s2 y densidad de ruido de salida de máximo 0.001 (m/s2)/Hz. Alternatively, the sensor (7) is selected from the group consisting of electromyogram (EMG), sensors for electrocardiograms, accelerometers, inertial sensors, microphones, magnetic sensors, pressure sensors, electric potential variation sensors, photoelectric, microelectromechanical systems (Microelectromechanic System , by its acronym in English MEMS) and combinations of the above. Preferably, the sensor (7) is a three-axis accelerometer for measuring spatial acceleration. An example of the sensor (7) is an accelerometer with a measuring range between -19.62 m / s 2 to +19.62 m / s 2 with a sensitivity of 0.0024 m / s 2 and an output noise density of maximum 0.001 (m / s). s 2 ) / Hz.
Alternativamente, el sensor (7) es un acelerómetro-magnetómetro con tres ejes para medir aceleración espacial y tres ejes para medir campo magnético espacial, para un total de seis ejes en funcionamiento híbrido. Esto permite que el método de la presente invención se pueda lograr la detección de un evento de apnea del sueño con mayor exactitud que si se procesara sólo la medida de un sensor (7) de sólo tres ejes. En referencia a la FIG. 1 y FIG. 2, el sensor (7) se encuentra dispuesto en el alojamiento interior (2) del cinturón (1) donde también se encuentra dispuesta la unidad de cómputo (6); estar físicamente cerca de la unidad de computo (6) es conveniente para minimizar la susceptibilidad electromagnética (Electromagnetic Susceptibility , por sus siglas en inglés EMS), debido que al reducir la longitud de los conductores eléctricos entre el sensor (7) y la unidad de cómputo (6) se reduce también área expuesta a EMI por tanto hay una menor probabilidad de que las ondas electromagnéticas que viajan por el aire se introduzcan en estos conductores eléctricos y se combinen con la señal del sensor(7) resultando en una señal con menor distorsión electrónica que si la distancia entre el sensor (7) y la unidad de cómputo (6) fuera mayor, es decir se mantiene la integridad de la señal del sensor (7) . Alternatively, the sensor (7) is an accelerometer-magnetometer with three axes to measure spatial acceleration and three axes to measure spatial magnetic field, for a total of six axes in hybrid operation. This allows the method of the present invention to achieve the detection of a sleep apnea event with greater accuracy than if only the measurement of a sensor (7) of only three axes was processed. With reference to FIG. 1 and FIG. 2, the sensor (7) is arranged in the inner housing (2) of the belt (1) where the counting unit (6) is also arranged; being physically close to the computing unit (6) is convenient for minimizing electromagnetic susceptibility (Electromagnetic Susceptibility, for its acronym in English EMS), because by reducing the length of the electrical conductors between the sensor (7) and the unit of computation (6) is also reduced area exposed to EMI therefore there is a lower probability that electromagnetic waves traveling through the air are introduced into these electrical conductors and combined with the sensor signal (7) resulting in a lower signal electronic distortion if the distance between the sensor (7) and the counting unit (6) were greater, that is, the integrity of the sensor signal (7) is maintained.
Para entendimiento de la presente invención se entenderá distorsión electrónica por la alteración que sufre la señal de entrada a través de un circuito electrónico hasta la salida. La distorsión electrónica de una señal, origina una diferencia entre los parámetros de la señal transmitida y la recibida, tales como su amplitud, frecuencia y fase. For understanding the present invention, electronic distortion will be understood as the alteration suffered by the input signal through an electronic circuit to the output. The electronic distortion of a signal causes a difference between the parameters of the transmitted and received signal, such as its amplitude, frequency and phase.
En referencia a la FIG. 2, la unidad de cómputo (6) se conecta un segundo sensor (9) y se dispone en un lugar diferente al lugar donde está dispuesto el transductor (5). En un ejemplo, el sensor (7) es un acelerómetro de tres ejes para medir aceleración espacial y el sensor (9) es un magnetómetro de tres ejes para medir campo magnético espacial, combinando los datos obtenido del sensor (7) y el sensor (9) con el método implementado en la unidad de cómputo (6) se puede establecer con exactitud la posición del usuario, las posiciones son por ejemplo decúbito supino y decúbito lateral. With reference to FIG. 2, the counting unit (6) connects a second sensor (9) and is arranged in a different place to the place where the transducer (5) is arranged. In one example, the sensor (7) is a three-axis accelerometer for measuring spatial acceleration and the sensor (9) is a three-axis magnetometer for measuring spatial magnetic field, combining the data obtained from the sensor (7) and the sensor ( 9) with the method implemented in the counting unit (6) the user's position can be established exactly, the positions are for example supine position and lateral decubitus position.
El sensor (9) se selecciona del grupo conformado por electromiograma (EMG), sensores para electrocardiogramas, acelerómetros, sensores inerciales, micrófonos, sensores magnéticos, sensores de presión, sensores de variación de potencial eléctrico, fotoeléctricos, sistemas microelectromecánicos y combinaciones de los anteriores. Preferiblemente, el sensor (9) es un sensor de tecnología MEMS con, tres ejes para medir campo magnético espacial con un rango de medición entre -1200 μΤ hasta +1200 μΤ con una sensibilidad de 0.1 μΤ y densidad de ruido (RMS) de 0.85 μΤ-rms. Alternativamente, el cinturón (1) cuenta con un elemento de accionamiento que se conecta a la unidad de cómputo (6) y dispuesto sobre en la porción central (8) con su domo orientado hacia exterior del alojamiento interior (2) del cinturón (1); el elemento de accionamiento se selecciona del grupo de interruptores eléctricos (por ejemplo pulsador, basculante, reed switch, termomagnético, magnético, DIP, de efecto Hall), pulsador de membrana entre otros equivalentes reconocidos por una persona medianamente versada en la materia y combinaciones. The sensor (9) is selected from the group consisting of electromyogram (EMG), sensors for electrocardiograms, accelerometers, inertial sensors, microphones, magnetic sensors, pressure sensors, electric potential variation sensors, photoelectric, microelectromechanical systems and combinations of the above . Preferably, the sensor (9) is a MEMS technology sensor with three axes to measure spatial magnetic field with a measurement range between -1200 μΤ to +1200 μΤ with a sensitivity of 0.1 μΤ and noise density (RMS) of 0.85. μΤ-rms. Alternatively, the belt (1) has an actuating element that is connected to the counting unit (6) and arranged on the central portion (8) with its dome oriented towards the exterior of the inner housing (2) of the belt (1); the actuating element is selected from the group of electrical switches (for example pushbutton, rocker, reed switch, thermomagnetic, magnetic, DIP, Hall effect), membrane pushbutton among other equivalents recognized by a person moderately skilled in the art and combinations.
El elemento de accionamiento a su vez puede estar en las siguientes configuraciones SPST (por sus siglas en inglés, Single Pole Single Throw), SPDT (por sus siglas en inglés, Single Pole Double Throw), DPST (por sus siglas en inglés, Double Pole Single Throw), DPDT (por sus siglas en inglés, Double Pole Double Throw) o combinaciones de estos, además puede ser normalmente abierto NO (por sus siglas en inglés, Normally Open) o normalmente cerrado NO (por sus siglas en inglés, Normally Closed). Por ejemplo un pulsador SPST-NO. The drive element in turn can be in the following configurations SPST (for its acronym in English, Single Pole Single Throw), SPDT (for its acronym in English, Single Pole Double Throw), DPST (for its acronym in English, Double Pole Single Throw), DPDT (for its acronym in English, Double Pole Double Throw) or combinations of these, in addition can be normally open NO (for its acronym in English, Normally Open) or normally closed NO (for its acronym in English, Normally Closed). For example, a SPST-NO button.
En referencia a la FIG. 5, la unidad de cómputo (6) cuenta con un circuito de carga de baterías (15) conformado por un socket USB (24) que conecta a un controlador de carga de baterías (25) y a un transistor (26). With reference to FIG. 5, the computing unit (6) has a battery charging circuit (15) formed by a USB socket (24) that connects to a battery charge controller (25) and a transistor (26).
Alternativamente, en la FIG. 5 el controlador de carga de baterías (25) es un circuito integrado de carga de baterías de corriente y voltaje contante que controla la carga de tipos de baterías de iones de litio, NiCD, NiMH y plomo ácido con voltajes que van desde 2.7 V hasta 29 V. En referencia a la FIG. 5, la unidad de cómputo (6) cuenta con un socket USB (24) que se selecciona de los tipos de socket USB Tipo-A, Tipo-B o Tipo-C en sus variantes mini y micro, para recarga eléctrica, programación y transferencia de datos. Es bien sabido por aquellos medianamente versados en el arte, que la interfaz USB trabaja a +5 V y su corriente máxima es de 0.5 A para el estándar USB 1.1 y USB 2.0 y 0.9 A para el estándar USB 3.0 lo que permite realizar la carga de la batería con que cuenta el cinturón (1). Alternatively, in FIG. 5 the battery charge controller (25) is an integrated current and constant voltage battery charging circuit that controls the charging of lithium ion, NiCD, NiMH and lead acid battery types with voltages ranging from 2.7 V to 29 V. With reference to FIG. 5, the computing unit (6) has a USB socket (24) which is selected from the types of USB socket Type-A, Type-B or Type-C in its mini and micro variants, for electric recharging, programming and data transfer. It is well known by those moderately versed in the art, that the USB interface works at +5 V and its maximum current is 0.5 A for the standard USB 1.1 and USB 2.0 and 0.9 A for the USB 3.0 standard which allows charging of the battery that the belt has (1).
Haciendo referencia a la FIG. 2, alternativamente se envían datos a través de un cable USB a una unidad de cómputo externa (14) para análisis posteriores, en un ejemplo, esto permite que se puedan descargar los registros de los movimientos de un usuario y mostrarse en gráficas de computadora y comprobar la efectividad de operación del dispositivo y método de la presente invención, en la detección, monitoreo y corrección de apnea del sueño. Haciendo referencia a la FIG. 2, la unidad de control (6) está conectada a un módulo de comunicaciones inalámbrico (13) que se conecta con una segunda unidad de cómputo externa (14). El módulo de comunicaciones inalámbrico (13) se selecciona de las tecnologías de comunicación inalámbricas como, Bluetooth, Wifi, Zigbee, RF, GPRS, WiMax y otras tecnologías equivalentes conocidas por una persona medianamente versada en la materia o combinaciones de las anteriores. Y la unidad de cómputo externa (14) se encuentra en un lugar diferente al cinturón (1) y la unidad de cómputo se selecciona de la lista de dispositivos procesadores de datos tales como: microcontroladores, micro procesadores, dsPICs, FPGAs, CPLDs, ASICs, SoCs, PSoCs, computadores, servidores, tabletas, celulares, celulares inteligentes y combinaciones de los anteriores. With reference to FIG. 2, alternatively data is sent via a USB cable to an external computing unit (14) for further analysis, in one example, this allows the logs of a user's movements to be downloaded and displayed in computer graphics and to check the effectiveness of operation of the device and method of the present invention, in the detection, monitoring and correction of sleep apnea. With reference to FIG. 2, the control unit (6) is connected to a wireless communication module (13) which is connected to a second external counting unit (14). The wireless communications module (13) is selected from wireless communication technologies such as Bluetooth, Wi-Fi, Zigbee, RF, GPRS, WiMax and other equivalent technologies known to a person of ordinary skill in the art or combinations thereof. And the external computing unit (14) is located in a different place than the belt (1) and the computing unit is selected from the list of data processing devices such as: microcontrollers, microprocessors, dsPICs, FPGAs, CPLDs, ASICs , SoCs, PSoCs, computers, servers, tablets, cell phones, smart phones and combinations of the above.
Haciendo referencia a las FIG. 3, FIG. 4 y FIG. 5, una unidad de cómputo (6) que conecta a: un transistor (5a) conectado a un transductor (5), un oscilador de alta frecuencia (18) un oscilador de baja frecuencia (19), un LED (11), un circuito integrado de referencia de voltaje (17), por medio de las señales 16a y 16b se encuentran conectados una unidad de almacenamiento (16) y un sensor (7), por medio de las señales (13a) y (13b) se conecta el módulo de comunicaciones inalámbrico (13), además se conectan los transistores (7a), (13c) y (16c), un puerto USB (20), un controlador de carca de baterías (15). With reference to FIGs. 3, FIG. 4 and FIG. 5, a computing unit (6) that connects to: a transistor (5a) connected to a transducer (5), a high-frequency oscillator (18), a low-frequency oscillator (19), an LED (11), a integrated circuit voltage reference (17), by means of the signals 16a and 16b are connected a storage unit (16) and a sensor (7), by means of the signals (13a) and (13b) is connected the wireless communication module (13), in addition transistors (7a), (13c) and (16c), a USB port (20), a battery case controller (15) are connected.
Haciendo referencia a la FIG. 4, el transductor (5) se activa utilizando un transistor (5a) debido a la capacidad de corriente que puede manejar la unidad de cómputo (6). El transistor cuenta con un diodo de protección integrado para su protección de corrientes provenientes del transductor (5), además el transductor (5) cuenta con diodo y condensador en paralelo para su protección eléctrica. El circuito integrado de referencia de voltaje (17) se provee el nivel de carga de la batería a la unidad de cómputo (6). Preferiblemente, un oscilador de alta frecuencia (18) establece la velocidad de trabajo de la unidad de cómputo (6). Preferiblemente ésta puede ser de 8 MHz; un oscilador de baja frecuencia (19) establece la funcionalidad de marcador de tiempo puede ser de 32.768 kHz, con esta frecuencia específica no hay desplazamientos significativos para medir tiempos de la ocurrencia de apnea del sueño, intervalo de tiempo de activación de transductor (5), intervalo de tiempo de sensibilidad de referencia y establecer diferentes ciclos de funcionamiento de la unidad de cómputo (6); un LED (11), que para el ejemplo ilustrado es un LED RGB, dicho LED (11) es un indicador de estado de funcionamiento, no funcionamiento o error, por ejemplo, el LED (11) presenta tres estados de funcionamiento al usuario, con un color verde indica que hay movimiento del usuario, con un color rojo indica que se presenta apnea del sueño, con color azul se presenta información sobre la transmisión de datos; un circuito integrado de referencia de voltaje (17), que da un indicador del nivel de carga de la batería a la unidad de control (6); una unidad de almacenamiento (16), preferiblemente, opera para almacenar valores de referencia y diferentes parámetros de configuración del equipo como por ejemplo, intervalo de tiempo para el envío de información del sensor (7) a través del módulo de comunicaciones inalámbrico (13) entre otros; un sensor (7), que sensa la información relevante para el monitoreo del sueño y la envía a la unidad de cómputo (6).; un módulo de comunicaciones inalámbrico (13), preferiblemente un módulo Bluetooth para enviar información a una unidad de cómputo externa. Así mismo, los transistores (7a), (13c) y (16c) implementados en el ejemplo sirven para controlar el encendido o apagado del sensor (7), del módulo de comunicaciones inalámbrico (13) y de la unidad de almacenamiento (16) para disminuir el consumo energético y prologar el tiempo de operación del dispositivo de la presente invención. With reference to FIG. 4, the transducer (5) is activated using a transistor (5a) due to the current capacity that the computing unit (6) can handle. The transistor has an integrated protection diode for protection of currents from the transducer (5), in addition the transducer (5) has a diode and capacitor in parallel for its electrical protection. The voltage reference integrated circuit (17) provides the level of charge of the battery to the counting unit (6). Preferably, a high frequency oscillator (18) sets the working speed of the counting unit (6). Preferably this may be 8 MHz; a low frequency oscillator (19) establishes the time marker functionality can be 32,768 kHz, with this specific frequency there are no significant shifts to measure times of the occurrence of sleep apnea, transducer activation time interval (5) , reference sensitivity time interval and set different operating cycles of the computing unit (6); an LED (11), which for the illustrated example is an RGB LED, said LED (11) is a status indicator of operation, non-operation or error, for example, the LED (11) presents three states of operation to the user, with a green color indicates that there is movement of the user, with a red color indicates that sleep apnea appears, with blue color information is presented about the transmission of data; an integrated voltage reference circuit (17), which gives an indicator of the charge level of the battery to the control unit (6); a storage unit (16), preferably, operates to store reference values and different device configuration parameters such as, for example, time interval for sending sensor information (7) through the wireless communication module (13) among others; a sensor (7), which senses the relevant information for sleep monitoring and sends it to the computer unit (6); a wireless communication module (13), preferably a Bluetooth module for sending information to an external computing unit. Likewise, the transistors (7a), (13c) and (16c) implemented in the example serve to control the switching on or off of the sensor (7), the wireless communication module (13) and the storage unit (16) to decrease the energy consumption and prolong the operating time of the device of the present invention.
Opcionalmente, la unidad de almacenamiento (16) puede ser un registro interno de la unidad de cómputo (6) y también puede ser externa a la unidad de cómputo (6). Optionally, the storage unit (16) can be an internal register of the counting unit (6) and can also be external to the counting unit (6).
Opcionalmente, el módulo de comunicaciones inalámbrico (13) se conecta a la unidad de cómputo (6) es un módulo de tecnología Bluetooth. Por lo que se puede enviar información a una unidad de cómputo externa (14), en el que se despliega información suministrada por los sensores (7) y (9). Optionally, the wireless communication module (13) is connected to the computing unit (6) is a Bluetooth technology module. Therefore, information can be sent to an external computing unit (14), in which information supplied by the sensors (7) and (9) is displayed.
Alternativamente, la batería se selecciona del grupo de baterías recargables de iones de litio, por ejemplo, baterías LFP, baterías NMC, baterías Li-S, baterías LiPo y otras baterías equivalentes conocidas por una persona medianamente versada en la materia, baterías de plomo ácido, baterías de plomo ácido avanzadas, baterías de hidruro metálico NiMH, baterías de níquel cadmio (NiCd), baterías de bromuro de zinc, baterías de sodio níquel/cloro NaNiCl, baterías zinc aire, baterías redox de vanadio, otras baterías equivalentes conocidas por una persona medianamente versada en la materia o combinaciones de las anteriores. Preferiblemente el dispositivo se conecta a una batería de iones de litio de 3.7 V 1000 mA/h, con esta batería el dispositivo de la invención se puede operar durante el transcurso del sueño del usuario desconectado de una fuente externa cableada, permitiendo comodidad al usuario antes de ser conectado para su recarga eléctrica. Alternatively, the battery is selected from the group of rechargeable lithium-ion batteries, for example, LFP batteries, NMC batteries, Li-S batteries, LiPo batteries and other equivalent batteries known to a person of ordinary skill in the art, lead acid batteries , advanced lead acid batteries, NiMH metal hydride batteries, nickel cadmium (NiCd) batteries, zinc bromide batteries, nickel / chlorine NaNiCl batteries, zinc air batteries, vanadium redox batteries, other equivalent batteries known for a person moderately versed in the subject or combinations of the previous ones. Preferably the device is connected to a lithium-ion battery of 3.7 V 1000 mA / h, with this battery the device of the invention can be operated during the course of the user's sleep disconnected from a wired external source, allowing the user comfort before being connected for electric recharging.
El método es implementado en una unidad de cómputo (6) y caracterizado por las etapas: a. establecer por un usuario, un umbral de sensibilidad de referencia de aceleración y un umbral de sensibilidad de referencia de campo magnético y almacenarlo en un registro de memoria; b. establecer por un usuario, un intervalo tiempo de sensibilidad de referencia y almacenarlo en un registro de memoria; c. establecer por un usuario un intervalo tiempo de activación de transductor y almacenarlo en un registro de memoria; d. monitorear y registrar mediante la unidad de cómputo la aceleración entregada por un sensor a una tasa de muestreo; e. comparar mediante la unidad de cómputo la señal monitoreada en la etapa d con el umbral de la etapa a; si el resultado de la comparación sobrepasa los umbrales establecidos en la etapa a durante el intervalo de tiempo de sensibilidad de la etapa b, entonces activar un transductor durante el intervalo de tiempo de activación establecido en la etapa c y volver a la etapa d. En caso contrario volver a etapa d. Opcionalmente, en el método implementado en la unidad de cómputo, en la etapa a se establece el umbral de sensibilidad de referencia de aceleración que va desde va desde - 19.62 m/s2 hasta +19.62 m/s2, este rango de sensibilidad de aceleración contiene ampliamente los rangos máximos y mínimos para la detección de un episodio de apnea del sueño. Por ejemplo, se puede establecer un mínimo que va desde -0.0024 m/s2 hasta +0.0024 m/s2 y un máximo de sensibilidad que va desde -19.62 m/s2 hasta + 19.62 m/s2. The method is implemented in a computing unit (6) and characterized by the steps: a. set by a user, an acceleration reference sensitivity threshold and a magnetic field reference sensitivity threshold and store it in a memory register; b. set by a user, a range of reference sensitivity time and store it in a memory register; c. establish by a user a transducer activation time interval and store it in a memory register; d. monitor and record through the computer unit the acceleration delivered by a sensor at a sampling rate; and. comparing through the computing unit the signal monitored in step d with the threshold of stage a; if the result of the comparison exceeds the thresholds established in step a during the sensitivity time interval of step b, then activate a transducer during the activation time interval established in step c and return to step d. Otherwise go back to stage d. Optionally, in the method implemented in the computing unit, in step a sensitivity threshold reference acceleration ranging from ranges from set - 19.62 m / s 2 to +19.62 m / s 2, this sensitivity range Acceleration contains widely the maximum and minimum ranges for the detection of an episode of sleep apnea. For example, a minimum ranging from -0.0024 m / s 2 to +0.0024 m / s 2 and a maximum sensitivity ranging from -19.62 m / s 2 to + 19.62 m / s 2 can be established .
Opcionalmente, en el método implementado en la unidad de cómputo, en la etapa a se establece el umbral de sensibilidad de referencia magnética que va desde -1200 μΤ hasta +1200 μΤ, este rango de sensibilidad magnética contiene ampliamente los rangos máximos y mínimos para determinar la posición del usuario. Opcionalmente, en el método implementado en la unidad de cómputo, en la etapa a se establece el umbral de sensibilidad de referencia de aceleración que va desde -19.62 m/s2 hasta +19.62 m/s2 y el umbral de sensibilidad de referencia magnética que va desde -1200 μΤ hasta +1200 μΤ, estos rangos de sensibilidad de aceleración y sensibilidad magnética contienen ampliamente los rangos máximos y mínimos para la detección de un episodio de apnea del sueño y determinar la posición del usuario respectivamente. Por ejemplo, para la sensibilidad de aceleración se puede establecer un mínimo que va desde -0.0024 m/s2 hasta +0.0024 m/s2 y un máximo de sensibilidad que va desde - 19.62 m/s2 hasta + 19.62 m/s2 y para la sensibilidad magnética se puede establecer un mínimo que va desde -1200 μΤ hasta +1200 μΤ y en un ejemplo, en la etapa e, el método combina las mediciones de un sensor de aceleración (7) con las mediciones de un segundo sensor (9) magnetómetro para trabajar de forma híbrida, dando un funcionamiento más exacto que si se utilizara sólo la señal de tres ejes de uno de los sensores. La redundancia permite aumentar la exactitud en la ubicación espacial del sujeto. Optionally, in the method implemented in the counting unit, in step a the magnetic reference sensitivity threshold is established, which ranges from -1200 μΤ to +1200 μΤ, this magnetic sensitivity range contains the maximum and minimum ranges to determine the position of the user. Optionally, in the method implemented in the computing unit, in step a sensitivity threshold reference acceleration ranging from -19.62 m / s 2 to +19.62 m / s 2 and the magnetic sensitivity threshold was fixed ranging from -1200 μΤ to +1200 μΤ, these ranges of sensitivity of acceleration and magnetic sensitivity widely contain the maximum and minimum ranges for the detection of an episode of sleep apnea and determine the position of the user respectively. For example, for the acceleration sensitivity a minimum can be established that goes from -0.0024 m / s 2 up to +0.0024 m / s 2 and a maximum sensitivity ranging from - 19.62 m / s 2 to + 19.62 m / s 2 and for magnetic sensitivity a minimum can be established that goes from -1200 μΤ to + 1200 μΤ and in one example, in step e, the method combines the measurements of an acceleration sensor (7) with the measurements of a second sensor (9) magnetometer to work in a hybrid manner, giving a more accurate operation than if will use only the three-axis signal from one of the sensors. Redundancy allows to increase the accuracy in the spatial location of the subject.
Preferiblemente, en el método implementado en la unidad de cómputo, en la etapa b un usuario establece un segundo intervalo de tiempo de sensibilidad de referencia y almacenarlo en un registro de memoria y en la etapa c un usuario establece un segundo intervalo de tiempo de activación de transductor y almacenarlo en un registro de memoria, en la etapa e, comparar la señal monitoreada en la etapa d con los umbrales de la etapa a; si el resultado de la comparación sobrepasa los umbrales establecidos en la etapa a durante el segundo intervalo de tiempo de sensibilidad de la etapa b, entonces activar un transductor durante el segundo intervalo de tiempo de activación establecido en la etapa c, volver a etapa d, si no se registra aceleración durante un segundo intervalo de activación entonces activar nuevamente el transductor durante el segundo intervalo de tiempo de activación establecido en la etapa c. donde el segundo intervalo de sensibilidad establecido por un usuario en la etapa b es menor que el primer intervalo de sensibilidad establecida por un usuario en la etapa b y de esta forma en un ejemplo del método de la presente invención se realizan activaciones periódicas del transductor si existe un evento de apnea del sueño y no fue efectiva la interrupción de la apnea del sueño inicial, así se incrementa la efectividad del dispositivo para interrumpir la apnea del sueño. Preferably, in the method implemented in the counting unit, in step b a user establishes a second reference sensitivity time interval and stores it in a memory register and in step c a user establishes a second activation time interval of transducer and storing it in a memory register, in step e, comparing the signal monitored in step d with the thresholds of stage a; if the result of the comparison exceeds the thresholds established in step a during the second sensitivity time interval of step b, then activate a transducer during the second activation time interval established in step c, return to step d, if no acceleration is recorded during a second activation interval, then activate the transducer again during the second activation time interval established in step c. where the second sensitivity range established by a user in step b is less than the first sensitivity range established by a user in step b and in this way in an example of the method of the present invention periodic activations of the transducer are made if there is a sleep apnea event and the interruption of the initial sleep apnea was not effective, thus increasing the effectiveness of the device to interrupt the sleep apnea.
Preferiblemente, en el método implementado en la unidad de cómputo, en la etapa d se registra la orientación de los ejes de un sensor (7) y un segundo sensor (9), en un ejemplo de la presente invención, este registro continuo en memoria de los movimientos del usuario sirven para determinar la posición del cuerpo del usuario con respecto a un marco de referencia global, y se pueden clasificar posiciones del usuario por ejemplo, decúbito supino y decúbito lateral. Esta información permite correlacionar la aparición de eventos de apnea versus hábitos posturales nocturnos del usuario. Preferably, in the method implemented in the counting unit, in step d the orientation of the axes of a sensor (7) and a second sensor (9) is recorded, in an example of the present invention, this continuous recording in memory the movements of the user serve to determine the position of the user's body with respect to a global reference frame, and positions of the user can be classified for example, supine decubitus and lateral decubitus. This information allows to correlate the appearance of apnea events versus nocturnal postural habits of the user.
Preferiblemente, en el método implementado en la unidad de cómputo, en la etapa b el primer intervalo de tiempo de sensibilidad va desde 6 segundos a 12 segundos, en un ejemplo de la invención, y de esta manera se permite un rango amplio para ajustar el tiempo en que una detección de estado de apnea del sueño es válida para un usuario en particular ya que este valor varía de usuario en usuario. Preferably, in the method implemented in the counting unit, in step b the first sensitivity time interval goes from 6 seconds to 12 seconds, in a example of the invention, and in this way a wide range is allowed to adjust the time in which a detection of sleep apnea status is valid for a particular user since this value varies from user to user.
Preferiblemente, en el método implementado en la unidad de cómputo, en la etapa c el primer intervalo de tiempo de activación del transductor va desde 1 segundo a 5 segundos, por ejemplo, usuario con un una alta sensibilidad a ciertos estímulos externos, por nombrar uno, las vibraciones, requerirán configurar un tiempo corto de activación del transductor mientras que otros usuarios menos sensibles a las vibraciones requerirán de un tiempo de activación del transductor mayor. Preferably, in the method implemented in the counting unit, in step c the first time interval of activation of the transducer goes from 1 second to 5 seconds, for example, user with a high sensitivity to certain external stimuli, to name one , vibrations, will require setting a short transducer activation time while other users less sensitive to vibrations will require a longer activation time of the transducer.

Claims

REIVINDICACIONES
1. Un dispositivo para detectar, monitorear y corregir trastornos del sueño de un usuario caracterizado por: a. un cinturón (1) conformado por: una porción central (8) con dos extremos y un alojamiento interior (2), una porción izquierda dorsal (3) a un primer extremo de la porción central (8) y una porción derecha dorsal (4) al segundo extremo de la porción central (8); b. una unidad de cómputo (6) dispuesta en el alojamiento interior (2) del cinturón1. A device for detecting, monitoring and correcting sleep disorders of a user characterized by: a. a belt (1) formed by: a central portion (8) with two ends and an inner housing (2), a dorsal left portion (3) at a first end of the central portion (8) and a right dorsal portion (4) ) to the second end of the central portion (8); b. a computing unit (6) arranged in the inner housing (2) of the belt
(i); c. un transductor (5) dispuesto en la porción izquierda dorsal del cinturón (1) o en la porción derecha dorsal del cinturón (1) y conectado a la unidad de cómputo (6); d. un sensor (7) conectado a la unidad de cómputo (6) y dispuesto en un lugar diferente al lugar donde está dispuesto el transductor (5); donde la unidad de cómputo (6) recibe señales generadas por el sensor (7) y controla el transductor (5). (i); c. a transducer (5) disposed in the left dorsal portion of the belt (1) or in the right dorsal portion of the belt (1) and connected to the counting unit (6); d. a sensor (7) connected to the counting unit (6) and arranged in a different place to the place where the transducer (5) is disposed; wherein the counting unit (6) receives signals generated by the sensor (7) and controls the transducer (5).
2. El dispositivo reclamado en la reivindicación 1 donde a la unidad de cómputo (6) se conecta un segundo sensor (9) y se dispone en un lugar diferente al lugar donde está dispuesto el transductor (5); The device claimed in claim 1 wherein a second sensor (9) is connected to the counting unit (6) and disposed in a different place to the place where the transducer (5) is disposed;
3. El dispositivo reclamado en la reivindicación 1 donde el cinturón (1) tiene un mecanismo de fijación que conecta el extremo exterior (3a) de la porción izquierda dorsalThe device claimed in claim 1 wherein the belt (1) has a locking mechanism that connects the outer end (3a) of the left back portion
(3) con el extremo exterior de la porción derecha dorsal (4a). (3) with the outer end of the right dorsal portion (4a).
4. El dispositivo reclamado en la reivindicación 1 donde el transductor (5) se selecciona del grupo conformado por mecanismos emisores de luz, LEDs, dispositivos electro-estimuladores, generadores de calor, generadores de frío, micro-vibradores, generadores de vibración, dispositivos piezoeléctricos, parlantes, actuadores lineales, dispositivos electromecánicos tipo pistón y combinaciones de los anteriores. The device claimed in claim 1 wherein the transducer (5) is selected from the group consisting of light emitting mechanisms, LEDs, electro-stimulating devices, heat generators, cold generators, micro-vibrators, vibration generators, devices piezoelectric, loudspeakers, linear actuators, piston-type electromechanical devices and combinations of the above.
5. El dispositivo reclamado en la reivindicación 1 donde el transductor (5) es un dispositivo de estimulación táctil. The device claimed in claim 1 wherein the transducer (5) is a tactile stimulation device.
6. El dispositivo reclamado en la reivindicación 5 donde el dispositivo de estimulación táctil está conformado por un motor con una excéntrica conectada a su eje. The device claimed in claim 5 wherein the tactile stimulation device is formed by a motor with an eccentric connected to its axis.
7. El dispositivo reclamado en la reivindicación 1 donde el sensor (7) se selecciona del grupo conformado por electromiograma (EMG), sensores para electrocardiogramas, acelerómetros, sensores inerciales, micrófonos, sensores magnéticos, sensores de presión, sensores de variación de potencial eléctrico, fotoeléctricos y combinaciones de los anteriores. The device claimed in claim 1 wherein the sensor (7) is selected from the group consisting of electromyogram (EMG), sensors for electrocardiograms, accelerometers, inertial sensors, microphones, magnetic sensors, pressure sensors, electric potential variation sensors , photoelectric and combinations of the above.
8. El dispositivo reclamado en la reivindicación 7 donde el sensor (7) es un acelerómetro de tres ejes para medir aceleración espacial. The device claimed in claim 7 wherein the sensor (7) is a three-axis accelerometer for measuring spatial acceleration.
9. El dispositivo reclamado en la reivindicación 2 donde el sensor (9) se selecciona del grupo conformado por electromiograma (EMG), sensores para electrocardiogramas, acelerómetros, sensores inerciales, micrófonos, sensores magnéticos, sensores de presión, sensores de variación de potencial eléctrico, fotoeléctricos y combinaciones de los anteriores. The device claimed in claim 2 wherein the sensor (9) is selected from the group consisting of electromyogram (EMG), sensors for electrocardiograms, accelerometers, inertial sensors, microphones, magnetic sensors, pressure sensors, electric potential variation sensors , photoelectric and combinations of the above.
10. El dispositivo reclamado en la reivindicación 9 donde el sensor (9) es un magnetómetro de tres ejes para medir campo magnético espacial. The device claimed in claim 9 wherein the sensor (9) is a three-axis magnetometer for measuring spatial magnetic field.
11. El dispositivo reclamado en la reivindicación 7 donde el sensor (7) es un acelerómetro-magnetómetro con tres ejes para medir aceleración espacial y tres ejes para medir campo magnético espacial, para un total de seis ejes en funcionamiento híbrido. The device claimed in claim 7 wherein the sensor (7) is an accelerometer-magnetometer with three axes for measuring spatial acceleration and three axes for measuring spatial magnetic field, for a total of six axes in hybrid operation.
12. El dispositivo reclamado en la reivindicación 1 donde el sensor (7) se encuentra dispuesto en el alojamiento interior (2) del cinturón (1). 12. The device claimed in claim 1 wherein the sensor (7) is disposed in the inner housing (2) of the belt (1).
13. El dispositivo reclamado en la reivindicación 1 y 12 donde el cinturón (1) se posiciona en la zona abdominal del usuario y en la porción central (8) dispone el sensor (7) sobre el ombligo del usuario. 13. The device claimed in claim 1 and 12 wherein the belt (1) is positioned in the abdominal area of the user and in the central portion (8) disposes the sensor (7) on the user's navel.
14. El dispositivo reclamado en la reivindicación 1 donde la unidad de cómputo (6) está conectada a un LED (11). 14. The device claimed in claim 1 wherein the computing unit (6) is connected to an LED (11).
15. El dispositivo reclamado en la reivindicación 1 donde la unidad de control (6) está conectada a un módulo de comunicaciones inalámbrico (13) que se conecta con un unidad de cómputo externa (14). The device claimed in claim 1 wherein the control unit (6) is connected to a wireless communication module (13) which is connected to an external computing unit (14).
16. El dispositivo reclamado en la reivindicación 1 donde la unidad de cómputo (6) cuenta con un circuito de carga de baterías (15) conformado por resistencias, condensadores, diodos, capacitores y un circuito integrado para el control de carga de baterías. 16. The device claimed in claim 1 wherein the computing unit (6) has a battery charging circuit (15) consisting of resistors, capacitors, diodes, capacitors and an integrated circuit for battery charge control.
17. Un método para para detectar, monitorear y corregir trastornos del sueño de un usuario implementado en una unidad de cómputo y caracterizado por las etapas: a. establecer por un usuario, un umbral de sensibilidad de referencia de aceleración y un umbral de sensibilidad de referencia de campo magnético y almacenarlo en un registro de memoria; b. establecer por un usuario, un intervalo tiempo de sensibilidad de referencia y almacenarlo en un registro de memoria; c. establecer por un usuario un intervalo tiempo de activación de transductor y almacenarlo en un registro de memoria; d. monitorear y registrar mediante la unidad de cómputo la aceleración entregada por un sensor a una tasa de muestreo; e. comparar mediante la unidad de cómputo la señal monitoreada en la etapa d con el umbral de la etapa a; si el resultado de la comparación sobrepasa los umbrales establecidos en la etapa a durante el intervalo de tiempo de sensibilidad de la etapa b, entonces activar un transductor durante el intervalo de tiempo de activación establecido en la etapa c y volver a la etapa d. En caso contrario volver a etapa d. 17. A method for detecting, monitoring and correcting sleep disorders of a user implemented in a computer unit and characterized by the steps: a. set by a user, an acceleration reference sensitivity threshold and a magnetic field reference sensitivity threshold and store it in a memory register; b. set by a user, a range of reference sensitivity time and store it in a memory register; c. establish by a user a transducer activation time interval and store it in a memory register; d. monitor and record through the computer unit the acceleration delivered by a sensor at a sampling rate; and. comparing through the computing unit the signal monitored in step d with the threshold of stage a; if the result of the comparison exceeds the thresholds established in step a during the sensitivity time interval of step b, then activate a transducer during the activation time interval established in step c and return to step d. Otherwise go back to stage d.
18. El método de la reivindicación 17 donde en la etapa a se establece el umbral de sensibilidad de referencia de aceleración que va desde va desde -19.62 m/s2 hasta +19.62 m/s2. 18. The method of claim 17 wherein in step a sensitivity threshold reference acceleration ranging from ranges from -19.62 m / s 2 to +19.62 m / s 2 is set.
19. El método de la reivindicación 17 donde en la etapa a se establece el umbral de sensibilidad de referencia magnética que va desde -1200 μΤ hasta +1200 μΤ. 19. The method of claim 17 wherein in step a the magnetic reference sensitivity threshold ranging from -1200 μΤ to +1200 μΤ is established.
20. El método de la reivindicación 17 donde en la etapa a se establece el umbral de sensibilidad de referencia de aceleración que va desde -19.62 m/s2 hasta +19.62 m/s2 y el umbral de sensibilidad de referencia magnética que va desde -1200 μΤ hasta +1200 μΤ. 20. The method of claim 17 wherein in step a sensitivity threshold reference acceleration ranging from -19.62 m / s 2 to +19.62 m / s2 and set the sensitivity threshold reference magnetic ranging from - 1200 μΤ up to +1200 μΤ.
21. El método de la reivindicación 17 donde en la etapa b un usuario establece un segundo intervalo de tiempo de sensibilidad de referencia y almacenarlo en un registro de memoria y en la etapa c un usuario establece un segundo intervalo de tiempo de activación de transductor y almacenarlo en un registro de memoria, en la etapa e, comparar la señal monitoreada en la etapa d con los umbrales de la etapa a; si el resultado de la comparación sobrepasa los umbrales establecidos en la etapa a durante el segundo intervalo de tiempo de sensibilidad de la etapa b, entonces activar un transductor durante el segundo intervalo de tiempo de activación establecido en la etapa c, volver a etapa d, si no se registra aceleración durante un segundo intervalo de activación entonces activar nuevamente el transductor durante el segundo intervalo de tiempo de activación establecido en la etapa c. donde el segundo intervalo de sensibilidad establecido por un usuario en la etapa b es menor que el primer intervalo de sensibilidad establecida por un usuario en la etapa b. The method of claim 17 wherein in step b a user establishes a second reference sensitivity time interval and stores it in a memory register and in step c a user establishes a second time interval of transducer activation and storing it in a memory register, in step e, comparing the signal monitored in step d with the thresholds of stage a; if the result of the comparison exceeds the thresholds established in step a during the second sensitivity time interval of step b, then activate a transducer during the second activation time interval established in step c, return to step d, if no acceleration is recorded during a second activation interval, then activate the transducer again during the second activation time interval established in step c. wherein the second sensitivity range established by a user in step b is less than the first sensitivity range established by a user in step b.
22. El método de la reivindicación 17 donde en la etapa d se registra la orientación de los ejes de un sensor (7) y un segundo sensor (9). 22. The method of claim 17 wherein in step d the orientation of the axes of a sensor (7) and a second sensor (9) is recorded.
23. El método de la reivindicación 17 donde en la etapa b el primer intervalo de tiempo de sensibilidad va desde 6 segundos a 12 segundos. 23. The method of claim 17 wherein in step b the first time interval of sensitivity ranges from 6 seconds to 12 seconds.
24. El método de la reivindicación 17 donde en la etapa c el primer intervalo de tiempo de activación del transductor va desde 1 segundo a 5 segundos. The method of claim 17 wherein in step c the first time interval of activation of the transducer ranges from 1 second to 5 seconds.
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