WO2008098365A1 - Procédé et appareil pour traiter les apnées du sommeil et les ronflements - Google Patents

Procédé et appareil pour traiter les apnées du sommeil et les ronflements Download PDF

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Publication number
WO2008098365A1
WO2008098365A1 PCT/CA2008/000288 CA2008000288W WO2008098365A1 WO 2008098365 A1 WO2008098365 A1 WO 2008098365A1 CA 2008000288 W CA2008000288 W CA 2008000288W WO 2008098365 A1 WO2008098365 A1 WO 2008098365A1
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WO
WIPO (PCT)
Prior art keywords
episode
person
stimulation
signal
onset
Prior art date
Application number
PCT/CA2008/000288
Other languages
English (en)
Inventor
Franco Ugo Villa
Original Assignee
Canzzz Investments Ltd.
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 Canzzz Investments Ltd. filed Critical Canzzz Investments Ltd.
Publication of WO2008098365A1 publication Critical patent/WO2008098365A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6822—Neck
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A61B7/003—Detecting lung or respiration noise
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3601—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs

Definitions

  • Embodiments of the present invention relate to an apparatus for treating snoring and obstructive sleep apnea, or either of them, and also relate to a method of treatment of these conditions, using electrical stimulation.
  • Snoring is a condition commonly caused by a partial obstruction of the upper airway, in which the airflow causes the obstructing tissue to resonate, resulting in characteristic and well known snoring sounds.
  • Snoring can be a major disruptive agent in relationships where one person is subjected to sleep disturbing effects, which the snoring partner causes.
  • Obstructive sleep apnea is a more serious medical condition caused by a more pronounced obstruction such that the airflow during breathing is severely restricted or is completely interrupted. This condition causes a degraded sleep pattern and reduced blood oxygenation and is believed to have the potential for producing serious medical problems, including cardiovascular complications.
  • the first article is entitled “Effects of Electrical Stimulation of the Genioglossus on Upper Airway Resistance in Anesthetized Dogs” by Hiroshi Miki et al.
  • the second article is entitled “Effects of Submental Electrical Stimulation During Sleep on Upper Airway Patency in Patient with Obstructive Sleep Apnea” also by Hiroshi Miki et al.
  • U.S. Patent No. 4,830,008 issued to Meer discusses an implantable system for treatment obstructive sleep apnea by means of electrical stimulation. A system achieving the same goal by the same means without resorting to implantation is discussed in U.S. Patent No. 5,265,624 issued to Bowman.
  • electrodes are placed on the gums, thus in the immediate vicinity of the genioglossus and related muscle groups in the upper airway, by means of a mouthpiece fitted with passive circuitry energized by radio frequency emitted by a collar assembly which incorporates the power supply and event detector. Radio frequency is processed within the mouthpiece in order to power the circuit and issue a train of narrow unidirectional pulses to the stimulating electrodes. Although not made evident in the writing, unidirectional pulses are effectively integrated into a direct current by storage components of capacitive and electrolytic nature intrinsic of the circuit pathway. Thus Bowman also relies on DC stimulation of the muscles of interest.
  • a disadvantage of the prior art devices is that there is a substantial likelihood that the stimulus they apply to the subject will degrade the subject's sleep quality. This negates the primary objective of restoring a restful sleep to the subject. Also, subjects are deterred from using user unfriendly, cumbersome contrivances such as that proposed by Bowman. CNZZOl -03PC
  • An apparatus for treating an obstruction of the upper airway of a person, such condition causing an episode of either snoring or obstructive sleep apnea comprises: a) a sensor for sensing the onset of said episode; b) a stimulus generator coupled to said sensor and responsible thereto for generating a stimulation signal for application to said person, said signal comprising a direct current and a pulsating current; c) said generator including a circuit activated upon the sensing of said episode for regulating the relative levels of said direct current and of said pulsating current as said stimulation signal is applied to said person; and d) a sensor for detecting the end of said episode and being coupled to said generator for terminating the application of said stimulation signal to said person following the end of said episode.
  • a method of treating a person having an obstruction of the upper airway causing the onset of either a snoring or an obstructive sleep apnea episode comprises: a) sensing the onset of said episode; b) upon the detection of said onset, applying an electrical stimulation signal to said person, said signal comprising a direct current and a pulsating current; c) regulating the relative levels of said direct current and said pulsating current as said signal is applied to said person; d) sensing termination of said episode; and e) following sensing said termination, terminating the application of said stimulation signal to said person.
  • Fig. 1 is a plan view of the inner front part of a neck strap, which supports components of a system according to the invention
  • Fig. 2 is a side sectional view of an electroacoustic transducer
  • Fig. 3 is a block diagram of a detection circuit which detects snoring and sleep apnea episodes; and [0014] Fig. 4 is a block diagram of a stimulus generator.
  • Fig. 1 is a plan view of the inner front of a neck strap 10 for use with embodiments of the present invention.
  • the neck strap 10 includes a main substrate 12 of woven material with a sufficiently open weave to allow for evaporation of skin 5 moisture.
  • the neck strap 10 supports conductive stimulation pads 14, 16 in spaced apart relation, an electroacoustic transducer 18 comprising an acoustic sensing diaphragm 22 and a conductive stimulation pad 14, and an insulating disc 20 which carries conductive stimulation pad 16.
  • the output of transducer 18 and conductive stimulation pads 14, 16 are connected to the supporting circuits for use with embodiments of the present invention by means of cable 10 24. Cable 24 also carries stimulation signals to conductive stimulation pads 14 and 16.
  • the neck strap 10 does not need to apply more than a gentle pressure on the skin, since the stimulation circuit path is of high impedance value at the source, to minimize the effects of such variables as resistance at the pad-skin interface and others of physiological nature.
  • Fig. 2 is a side section view of electroacoustic transducer 18, which includes
  • supporting structure 26 made of insulating plastic such as polycarbonate.
  • the front of transducer 18 carries acoustic sensing diaphragm 22 made of thin polyamide foil or other material with similar mechanical electrical specifications.
  • Diaphragm 22 is bonded at the periphery to the flat rim of supporting structure 26 and it carries conductive stimulation pad 14, pad 14 being in the form of a disc made of thin stainless steel foil bonded to diaphragm 22 0 at the centre of diaphragm 22.
  • a thin conductive wire 30 connects pad 14 to terminal 32 on the back of the supporting structure 26.
  • Air cavity 38 is the site where an acoustic pressure is generated by diaphragm 22 when diaphragm 22 is vibrating in response to acoustical events such as breathing airflow and snoring, by virtue of being positioned in intimate contact with the skin of the throat.
  • the acoustic pressure is converted into an electrical signal by 5 microphone 34, which is affixed with a sealing bond in a centre hole of supporting structure 26.
  • a shielding disc 36 is an electrostatic shield which prevents stimulation pulses present on pad 14 from interfering with the minute signal output by microphone 34.
  • Shielding disc 36 is mechanically supported by three or four wires 40 which have also electrically connect disc 36 to ground ring 42 which is the ground reference of the circuit. This connection further aids in 0 making the output of microphone 34 free of interference.
  • Terminal 44 is the output connection of microphone 34.
  • Fig. 3 is a block diagram of a detection circuit which detects snoring and sleep apnea episodes.
  • the signal from microphone 34 is amplified by amplifiers 50, 60 and then applied in two branches to bandpass filters 52, 62 which extract telltale signatures respectively of breathing and snoring activity.
  • bandpass filters 52, 62 which extract telltale signatures respectively of breathing and snoring activity.
  • Various types of signal processing are well known to those skilled in the art to detect breathing activity and snoring activity and to filter out extraneous signal components.
  • the snoring signal is directed to full wave rectifier 64 and then to internally referenced comparator 66, which outputs a logic one if snoring is sensed.
  • the breathing signal from bandpass filter 52 is rectified by full wave rectifier 54, the output of which is directed to internally referenced comparator 56 which outputs a logic one if the acoustic signature of air flow is detected.
  • the output of comparator 56 is used to reset a timer 58, the output of which is set to go high after an interval of four to six seconds following any reset. Respiration cycles are typically four to six seconds and therefore the timer 58 is reset every equivalent time interval (i.e. every respiration cycle). Thus the timer 58 will output a logic one if a breathing pattern is not detected for more than six seconds.
  • the range of four to six seconds is suggested as from experimentation this appears to be the optimal range for effective use of embodiments of the present invention.
  • Snoring events are characterized by a logic one at the output 74 and apnea events by a logic one at output 70.
  • Outputs 70, 74 are directed to the inputs of OR gate 68, which outputs at 72.
  • the information present at points 70, 72, 74 is directed to the processing circuits of the stimulus generator illustrated with reference to Fig. 4.
  • Fig. 4 is a block diagram of a stimulus generator.
  • Astable oscillator 78 is set running by a logic one at the output of OR gate 76.
  • the frequency of astable oscillator 78 is controlled by means of variable resistor 80 within a range of approximately three to 10 pulses per second.
  • the output of astable oscillator 78 is directed to a Schmitt trigger 86, via a resistor-capacitor network of capacitor 82 and variable resistor 84, with a time constant in the range of fifty microseconds to fifty milliseconds.
  • the output of Schmitt trigger 86 is a train of pulses with a width equivalent to the time constant of the input network.
  • the pulse train issued by Schmitt trigger 86 is directed to level risetime control 88, which sets the amplitude CNZZOl -03PC
  • the time for pulse amplitude to reach the pre-selected value is made to be within 1 second after the sensing of a snoring event and seconds following the sensing of an apnea event, the information being supplied by apnea and snoring information present at points 70 and 74 respectively.
  • the output of level risetime control 88 is directed to output driver 90, which also converts the unidirectional pulses at its input into symmetrical square waves, which are then applied to the primary of step-up transformer 92. Thus square waves with the required high voltage are present at the secondary winding of transformer 92.
  • HV inverter 94 raises the power source voltage to the level required for stimulation.
  • any number of power sources may be used to power the circuitry of embodiments of the present invention, a battery being one such example.
  • the time for the voltage to reach a maximum value is set by DC level risetime control 96. In one embodiment the time would be three seconds after the onset of an apnea event and zero seconds after the onset of snoring, this being accomplished by pertinent information at points 70, 74 applied to level risetime control 96.
  • Maximum level is set by DC max level control 98 which in one embodiment reduces the level by 50% if snoring information is present at point 74.
  • DC at the output of level control 98 is directed to polarity control unit 106 via the secondary of transformer 92, which is connected in series in the stimulation circuit.
  • a stimulation signal thus consists of a DC current with a square wave pulse train superimposed on it, the balance between the two modes being apt to be adjusted as required.
  • This composite signal is directed to conductive stimulation pads 14, 16 via polarity control 106, which assigns ground level and high level to either one depending on the output status of FLIP-FLOP 104 which is clocked by apnea or snoring information at point 72.
  • the polarity applied to conductive stimulation pads 14, 16 is reversed at every new episode of stimulus generator operation, this being done to counteract effects of a constant polarity DC current such as electrolytic effects at the pad-skin interface and possible increase of the threshold of stimulation level.
  • pulse stimulation is applied to the subject with the level reaching maximum in one second, the level rise being interrupted at the CNZZOl -03PC
  • DC stimulation is also applied to the subject, with a level reaching 50% of a pre-set maximum with no delay.
  • DC stimulation is also interrupted at a level where the condition is interrupted.
  • Reason for such process is that while DC stimulation acts to open the airway with a minimum of perceived effect by the subject, pulse stimulation is perceived as a tingle evoking a condition in which the event is terminated. Said perceived stimulus has the effect of conditioning the subject into subconsciously avoiding a posture conducive to snoring.
  • the sudden application of a reduced DC level also contributes to perception.
  • Stimulation is interrupted at the level which causes the event to cease. If the episode is not corrected at maximum DC stimulation level, which is characterized by a logic one at the output of internally referenced comparator 102 and presented to one input of AND gate 108, the other input seeing also logic one at point 70. Therefore the output of gate 108 starts astable oscillator 78, the end result being pulse stimulation with a level risetime of six seconds compounding the DC stimulus.
  • the conductive stimulation pads 14, 16 through which the stimulation is applied have in one embodiment an active surface of one cm 2 to five cm 2 and are positioned approximately five cm to ten cm apart symmetrically to the muscle group to be stimulated. This has been found to also be an optimum area for acoustic detection of the acoustical signature of breathing, being the region of highest turbulence in the air flow, caused by restrictions which lead to or cause snoring and apnea. However, these parameters are not critical. The system is tolerant of axial offset between the stimulated region and the position of the pads, although the best results have been found if the offset is made equivalent to the spacing between the pads.
  • the stimulation pulses applied to the subject person may be relatively high voltage
  • the short duration of the pulses ensures that the overall integrated energy of each pulse is limited to values which are a fraction of a millijoule.
  • the DC stimulation current is limited to fractions of a milliamp, even if the voltages at play may be substantial by reason of a source resistance which is designed to be one order of magnitude or more higher than the CNZZOl -03PC
  • the high surface area of the pads 14, 16 ensure that the current density at skin level be kept sufficiently low to avoid disturbing the subject person with the perception of an electric shock.
  • the neck strap 10 may be fastened by any desired means, e.g. hook and loop pads (not shown) attached to the ends of the strap.
  • the supporting electronics may be housed in a unit smaller than a typical cell phone, placed inside a suitable pocket of a T-shirt or other type of garment.
  • the electrical connection to components on the neck strap is accomplished by a flexible miniature cable (Feature 24 of Fig. 1) in which the conductors carry the microphone signal and stimulation current.
  • the device of embodiments of the present invention may be placed on a night table or other suitable place or, with suitable miniaturization be contained on the neck strap.
  • Functions of the device may be augmented with snoring and sleep apnea event counters. Different processing means may be used, reflecting continuous, rapid advancements in the electronic arts.
  • the circuits described in the examples shown are examples of one implementation of embodiments of the present invention. As one skilled in the art will recognize the circuits may be created from numerous combinations of discrete components, both analog and digital. Further one skilled in the art can design circuits in other topologies to achieve the desired results. Various muscles or muscle groups may be stimulated to terminate snoring or a sleep apnea episode. Further changes may be made without departing from the scope of the present invention.

Abstract

Cette invention se rapporte à un procédé et un dispositif permettant de traiter les ronflements et l'apnée obstructive du sommeil. Ledit dispositif comporte un capteur qui détecte le début d'un épisode de ronflement ou d'apnée du sommeil et qui entraîne la production d'un signal électrique de stimulation constitué d'une association de courant continu et d'un train d'impulsions alternées, avec les fonctions respectives d'ouverture des voies respiratoires restreintes par stimulation de groupes musculaires associés et de déclenchement d'une réponse d'éveil partiel, qui corrigent ainsi l'état pathologique. Le début des épisodes est détecté par un transducteur acoustique, les épisodes se distinguant les uns des autres par leur signature acoustique unique grâce à un moyen de traitement des signaux approprié, le transducteur acoustique portant également l'une des deux électrodes de stimulation, qui sont maintenues contre la gorge du patient par un serre-nuque d'un poids léger.
PCT/CA2008/000288 2007-02-14 2008-02-14 Procédé et appareil pour traiter les apnées du sommeil et les ronflements WO2008098365A1 (fr)

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Application Number Priority Date Filing Date Title
CA2578713 2007-02-14
CA 2578713 CA2578713A1 (fr) 2007-02-14 2007-02-14 Methode et appareil pour traiter l'apnee du sommeil et les ronflements

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013086212A1 (fr) * 2011-12-07 2013-06-13 Otologics, Llc Dispositif de régulation de l'apnée du sommeil
CN103169474A (zh) * 2011-12-20 2013-06-26 博伊雷尔有限责任公司 移动式监测、分析和治疗辅助仪器
WO2013113950A1 (fr) * 2012-01-31 2013-08-08 Torytrans, S.L. Méthode et système d'électrostimulation pour le traitement de l'apnée du sommeil
WO2016094390A1 (fr) * 2014-12-08 2016-06-16 Coats Andrew Justin Stewarts Dispositif anti-ronflement à induction magnétique
EP3287065A1 (fr) 2016-08-26 2018-02-28 Iptasys GmbH Appareil destine a surveiller et a influencer le sommeil d'une personne et procede mis en oeuvre par ordinateur destine a faire fonctionner l'appareil

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4830008A (en) * 1987-04-24 1989-05-16 Meer Jeffrey A Method and system for treatment of sleep apnea
US5265624A (en) * 1990-09-06 1993-11-30 Edentec Stimulation collar
US6251126B1 (en) * 1998-04-23 2001-06-26 Medtronic Inc Method and apparatus for synchronized treatment of obstructive sleep apnea
US6618627B2 (en) * 1998-11-13 2003-09-09 Respironics, Inc. Intraoral electromuscular stimulating device and method
US20050107838A1 (en) * 2003-09-18 2005-05-19 Lovett Eric G. Subcutaneous cardiac rhythm management with disordered breathing detection and treatment

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4830008A (en) * 1987-04-24 1989-05-16 Meer Jeffrey A Method and system for treatment of sleep apnea
US5265624A (en) * 1990-09-06 1993-11-30 Edentec Stimulation collar
US6251126B1 (en) * 1998-04-23 2001-06-26 Medtronic Inc Method and apparatus for synchronized treatment of obstructive sleep apnea
US6618627B2 (en) * 1998-11-13 2003-09-09 Respironics, Inc. Intraoral electromuscular stimulating device and method
US20050107838A1 (en) * 2003-09-18 2005-05-19 Lovett Eric G. Subcutaneous cardiac rhythm management with disordered breathing detection and treatment

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013086212A1 (fr) * 2011-12-07 2013-06-13 Otologics, Llc Dispositif de régulation de l'apnée du sommeil
US8892205B2 (en) 2011-12-07 2014-11-18 Otologics, Llc Sleep apnea control device
CN103169474A (zh) * 2011-12-20 2013-06-26 博伊雷尔有限责任公司 移动式监测、分析和治疗辅助仪器
WO2013091613A1 (fr) 2011-12-20 2013-06-27 Beurer Gmbh Appareil mobile de surveillance, d'analyse et d'assistance thérapeutique
CN103491878A (zh) * 2011-12-20 2014-01-01 博伊雷尔有限责任公司 移动的辅助监测、分析及治疗仪
WO2013113950A1 (fr) * 2012-01-31 2013-08-08 Torytrans, S.L. Méthode et système d'électrostimulation pour le traitement de l'apnée du sommeil
US9114256B2 (en) 2012-01-31 2015-08-25 Torytrans, S.L Electrostimulation method and system for the treatment of sleep apnea
WO2016094390A1 (fr) * 2014-12-08 2016-06-16 Coats Andrew Justin Stewarts Dispositif anti-ronflement à induction magnétique
EP3287065A1 (fr) 2016-08-26 2018-02-28 Iptasys GmbH Appareil destine a surveiller et a influencer le sommeil d'une personne et procede mis en oeuvre par ordinateur destine a faire fonctionner l'appareil

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