US20100328075A1

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Publication number: US20100328075A1
Application number: US12/762,563
Authority: US
Inventors: Shaked Rahamim; Ori Elyada
Original assignee: Individual
Current assignee: Individual
Priority date: 2007-10-18
Filing date: 2010-04-19
Publication date: 2010-12-30
Also published as: CN101917903A; WO2009050702A3; CN101917903B; WO2009050702A2; IL186768A0; US9445747B2; JP2011501990A; EP2222226A2; US20130123654A1

Abstract

An apnea detector is disclosed. In some embodiments, a detector unit in communication with a capacitive type sensor is adapted to receive an electrical signal which is indicative of variable capacitance resulting from movement of a subject and to emit an alert signal when the received electrical signal is indicative of symptoms of apnea. In one embodiment, a detector unit is in communication with a curvature sensor adapted to detect a variable curvature of a subject body surface resulting from breathing patterns of a subject. The detector unit is attached to an article of clothing of the subject. A monitoring system comprises a detector unit for detecting one or more subject related parameters of interest and for emitting acoustical information after determining that a subject related parameter of interest has a predetermined status, and a stationary unit disposed within an audible range of the detector unit for receiving the emitted acoustical information.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of PCT/IL2008/001349 filed on Oct. 12, 2008 and published as WO 2009/050702, and claims priority to Israel Patent Application 186768 filed on Oct. 18, 2007, which are all hereby incorporated in their entirety by reference.

FIELD OF THE INVENTION

The present invention relates to the field of monitoring systems. More particularly, the invention relates to an apnea detector that is embedded in a diaper or otherwise attached to an article of clothing.

BACKGROUND OF THE INVENTION

A constant concern of parents of a sleeping infant, generally less than one year old, is the onset of sudden infant death syndrome (SIDS). Parents usually inspect the breathing patterns of their infant several times during a nighttime period to determine whether there are signs of the onset of SIDS.

It would be desirable to provide a reliable and inexpensive detector for infant apnea, which is one of the most recognizable signs of SIDS. An infant who has ceased to breathe can be revived only if a parent, who has been trained to provide first aid care, is immediately alerted to such a life threatening condition.

Some adults are also prone to sleep apnea due to various medical causes. It would be desirable to provide a reliable and ergonomic detector for monitoring sleep apnea and for stimulating the subject to awake when sleep apnea occurs.

Three types of prior art apnea detectors are known:

- 1) An apnea detector such as disclosed in U.S. Pat. No. 5,271,412, WO 2005/074379, U.S. Pat. No. 4,146,885 and U.S. Pat. No. 5,684,460 is placed underneath the mattress of the infant, and a parent is immediately alerted when apnea is detected. It is needless to say that this type of detector is unable to detect apnea when the infant is not sleeping, such as when playing, or when not sleeping on his mattress. This type of detector is also relatively expensive to manufacture. Another disadvantage of this type of apnea detector is that the mattress is interposed between the infant and the detector that senses the breathing pattern of the infant. The received signal is therefore attenuated by the mattress material, and its transmission is also delayed due to the gradual relaxation of the spongy mattress material, causing a life threatening delay during an apnea event.
- 2) One type of apnea detector, such as disclosed in U.S. Pat. No. 5,454,376 or U.S. Pat. No. 5,241,300, involves a wearing apparel having an elastic belt that extends about the chest or abdomen of the infant. A strain gauge is secured to the belt and detects breathing movement through the expansion and contraction of the chest wall. Such a detector is uncomfortable or even dangerous to the wearer, particularly during the nighttime hours, due to the pressure exerted by the elastic belt, and therefore cannot be used during an entire 24-hour period. Apnea cannot be detected when the wearing apparel is being laundered. Additional disadvantages of this type of detector are that the detector is not suitable for different sized infants and that it is not capable for detecting moisture in a diaper.
  - U.S. Pat. No. 5,295,490, U.S. Pat. No. 4,696,307, U.S. Pat. No. 4,989,612, U.S. Pat. No. 5,107,855, and U.S. Pat. No. 5,400,012 disclose a variation of this type of apnea detector in which belt means encircling a portion of the body of a patient expands and contracts in response to respiration of the patient. This belt means poses a risk of entanglement and suffocation to the monitored infant.
- 3) Another type of apnea detector, such as disclosed in GB 2261290, U.S. Pat. No. 3,782,368, U.S. Pat. No. 5,684,460, U.S. Pat. No. 6,267,730 and WO 2005/011491, comprises a piezoelectric element for detecting deflections caused by respiratory and heart functions. A piezoelectric element is relatively expensive, and therefore is not disposable. Also, a piezoelectric element is fragile, and may be easily broken by the infant or by his parents, therefore constituting an unreliable detector.

Other apnea detectors are disclosed in WO 02/34133, JP 9,187,431, U.S. Pat. No. 5,993,397 and U.S. Pat. No. 6,267,730.

U.S. Pat. No. 5,838,240 and U.S. Pat. No. 6,677,859 disclose the use of a capacitive sensor for detecting moisture, such as in a diaper. A capacitive sensor has not been used heretofore to detect sleep apnea.

It is an object of the present invention to provide a reliable and inexpensive detector for infant apnea.

It is an additional object of the present invention to provide an infant apnea detector and system, which are operable throughout a 24-hour period, even when the infant is awake and not in a prone position.

It is an additional object of the present invention to provide an infant apnea sensor that is embedded within a diaper.

It is an additional object of the present invention to provide an infant apnea sensor that is disposable.

It is an additional object of the present invention to provide an infant apnea detector that is comfortable and safe to the infant.

It is an additional object of the present invention to provide an infant apnea detector that is difficult to be removed by the infant from the diaper to which it is attached.

It is an additional object of the present invention to provide an infant apnea detector and system that are also capable of detecting wetness and other infant related parameters of interest.

It is yet an additional object of the present invention to provide an infant apnea detector system that can instantly alert a parent upon detection of apnea.

It is yet an additional object of the present invention to provide an infant apnea detector system that does not expose the infant to close-proximity radio frequency (RF) radiation.

It is yet an additional object of the present invention to provide an infant apnea detector and sensor that are not in direct contact with the body of the infant.

Other objects and advantages of the invention will become apparent as the description proceeds.

SUMMARY OF THE INVENTION

The present invention provides an apnea detector which comprises a capacitive type sensor adapted to detect a variable capacitance resulting from movement of a subject, such as the breathing patterns of the subject, and a detector unit in communication with said sensor for receiving an electrical signal from said capacitive type sensor which is indicative of said variable capacitance and for emitting an alert signal, such as by alerting an attendant, when said received electrical signal is indicative of symptoms of apnea, said detector unit being attached to an article of clothing of the subject, such as a diaper.

As referred to herein, a “subject” is one who is being monitored by means of an apnea detector, e.g. an adult subject or an infant subject.

In one aspect, the detector unit is releasably attached to an article of clothing of the subject.

In one aspect, the capacitive type sensor is adapted to detect a variable capacitance between two serially connected capacitor plates and a body surface of the subject.

In one aspect, the subject is an infant and the detector unit is attached to a diaper.

In one aspect, the capacitive type sensor comprises a conductive surface constituting a capacitor plate which is applied to a suitable diaper surface, e.g. an inner face of a diaper outer layer, such as being attached thereto, said sensor adapted to detect a variable capacitance between said plate and a body surface of the subject.

The variable capacitance is dependent upon an instantaneous capacitance of diaper absorbent core material and an air gap interposed between the plate and the subject body surface.

In one aspect, the conductive surface is applied to a suitable diaper surface by conductive ink or hot foil stamping.

In one aspect, the conductive surface is attached to a suitable diaper surface.

In one aspect, the sensor is capacitively coupled to the detector unit.

In one aspect, the detector unit is in communication with said sensor by means of electric contacts.

The detector unit preferably comprises a microcontroller, an enunciator in communication with said microcontroller for emitting acoustical information when symptoms of apnea are detected, a battery, a flexible or rigid printed circuit board, means for communicating with the capacitive type sensor, and a recessed button for activating or deactivating said microcontroller or for silencing an enunciated alarm signal.

The microcontroller receives and processes electrical signals from the sensor, and determines by means of a firmware algorithm whether symptoms of apnea are being exhibited. Subject related parameters are stored in an event log module which is associated with the microcontroller. Data is exchanged with the microcontroller by means of an external data interface.

In one aspect, the means for communicating with the capacitive type sensor comprises a coupling pad externally attached to a detector unit casing underside and electrically connected with the printed circuit board.

In one aspect, the detector unit comprises two or more coupling pads, for communicating with two or more spaced capacitive type sensors.

In one aspect, the detector unit further comprises an optical indicator in communication with the microcontroller for visually alerting an attendant when symptoms of apnea are detected or for indicating a detector status.

In one aspect, the detector unit is also in communication with one or more additional sensors adapted to detect infant related parameters of interest, which are selected from the group of urine detection, feces detection, subject heartbeat detection, ambient temperature and humidity, illumination level, infant locating transponder, body temperature, body activity, oxygen saturation of arterial blood, and sleeping orientation of infant.

In one aspect, the capacitive type sensor comprises two spaced conductive surfaces constituting capacitor plates which are applied to a substrate, said substrate being embedded within diaper absorbent core material such that said two spaced conductive surfaces face each other, said sensor adapted to detect a variable capacitance between said two spaced conductive surfaces.

The present invention is also directed to an apnea detector which comprises a curvature sensor adapted to detect a variable curvature of a subject body surface resulting from breathing patterns of a subject, and a detector unit in communication with said sensor for receiving an electrical signal from said curvature sensor which is indicative of said variable curvature and for emitting an alert signal when said received electrical signal is indicative of symptoms of apnea, said detector unit being attached to an article of clothing.

The curvature sensor is selected from the group of a resistive strain gauge, a flexion sensor, a piezoelectric transducer, a sensor made of piezoresistive materials, a fiber optic element for measuring bending or stretching by means of optical refraction, diffraction, scattering, transmissivity, or polarization, and a force-sensitive resistor.

In one aspect, the detector unit comprises a microcontroller, an enunciator in communication with said microcontroller for emitting acoustical information when symptoms of apnea are detected, a battery, a flexible or rigid printed circuit board, means for communicating with the curvature sensor, and a recessed button for activating or deactivating said microcontroller or for silencing an enunciated alarm signal.

The present invention is also directed to a subject monitoring system which comprises a detector unit for detecting one or more subject related parameters of interest and for emitting acoustical information after determining that a subject related parameter of interest has a predetermined status, and a stationary unit disposed within an audible range of said detector unit for receiving said emitted acoustical information.

The stationary unit preferably comprises a microphone, a microcontroller, means for filtering noise and tones that have a frequency outside a predetermined frequency band and for transmitting filtered signals to said stationary unit microcontroller, and means for generating an alert signal when said stationary unit microcontroller determines that the filtered signals are indicative of a predetermined audio signal emitted by the detector unit.

In one aspect, the predetermined audio signal emitted by the detector unit is an acoustical signature.

In one aspect, the alert signal generated by the stationary unit is a high-volume warning signal.

In one aspect, the alert signal is adapted to alert an authorized attendant that a subject related parameter of interest has a predetermined status.

In one aspect, the stationary unit further comprises a transceiver, the alert signal being a wireless signal transmitted by said stationary unit transceiver.

In one aspect, the stationary unit comprises means for receiving, amplifying and emitting acoustical information enunciated by the subject.

In one aspect, the stationary unit comprises a display in communication with the stationary unit microcontroller for outputting textual information indicative of the predetermined subject status.

In one aspect, the stationary unit comprises one or more optical indicators in communication with the stationary unit microcontroller, illumination of each of said indicators being indicative of generation of an alarm signal.

In one aspect, the stationary unit further comprises an external data interface for exchanging data with the stationary unit microcontroller.

In one embodiment, the system further comprises a portable unit in communication with the stationary unit transceiver via a communication network, said portable unit being accessible to the authorized attendant and adapted to enunciate acoustical information emitted by the stationary unit.

In one aspect, a subject related parameter of interest detected by the detector unit is a characteristic breathing pattern value (CBPV).

In one aspect, a capacitive type sensor in communication with the detector unit transmits an electrical signal thereto which is indicative of a variable capacitance CBPV.

In one aspect, the capacitive type sensor comprises a conductive surface applied to a suitable diaper surface, said sensor adapted to detect a variable capacitance between said surface and a body surface of an infant.

In one aspect, a curvature sensor in communication with the detector unit transmits an electrical signal thereto which is indicative of a variable curvature CBPV representing a variable curvature of a subject body surface.

In one embodiment, the system further comprises an override unit in communication with the stationary unit transceiver and connected to a set-top box of a home entertainment system, said override unit adapted to interrupt the display of a program on said home entertainment system and to display a predetermined video frame thereon.

Some embodiments relate to an apnea detector, comprising a capacitive type sensor adapted to detect a variable capacitance resulting from movement of a subject, and a detector unit in communication with said sensor for receiving an electrical signal from said capacitive type sensor which is indicative of said variable capacitance and for emitting an alert signal when said received electrical signal is indicative of symptoms of apnea, said detector unit being attached to an article of clothing of the subject.

In some embodiments, the capacitive type sensor is adapted to detect a variable capacitance resulting from breathing patterns of the subject.

In some embodiments, the detector unit is releasably attached to an article of clothing of the subject.

In some embodiments, the subject is an infant and the detector unit is attached to a diaper.

In some embodiments, the capacitive type sensor comprises a conductive surface constituting a capacitor plate which is applied to a suitable diaper surface, said sensor adapted to detect a variable capacitance between said plate and a body surface of the infant.

In some embodiments, the variable capacitance is dependent upon an instantaneous capacitance of diaper absorbent core material and an air gap interposed between the plate and the infant body surface.

In some embodiments, the suitable diaper surface is an inner face of a diaper outer layer.

In some embodiments, the conductive surface is applied to a suitable diaper surface by conductive ink or hot foil stamping.

In some embodiments, the conductive surface is attached to a suitable diaper surface.

In some embodiments, the sensor is capacitively coupled to the detector unit.

In some embodiments wherein the detector unit is in communication with said sensor by means of electric contacts.

In some embodiments, the detector unit comprises a microcontroller, an enunciator in communication with said microcontroller for emitting acoustical information when symptoms of apnea are detected, a battery, a flexible or rigid printed circuit board, means for communicating with the capacitive type sensor, and a recessed button for activating or deactivating said microcontroller or for silencing an enunciated alarm signal.

In some embodiments, the means for communicating with the capacitive type sensor comprises a coupling pad externally attached to a detector unit casing underside and electrically connected with the printed circuit board.

In some embodiments, the detector unit comprises two or more coupling pads, for communicating with two or more spaced capacitive type sensors.

In some embodiments, the detector unit further comprises an optical indicator in communication with the microcontroller for visually alerting an attendant when symptoms of apnea are detected or for indicating a detector status.

In some embodiments, the detector unit is also in communication with one or more additional sensors adapted to detect subject related parameters of interest.

In some embodiments, wherein the subject related parameters of interest are selected from the group of urine detection, feces detection, heartbeat detection, ambient temperature and humidity, illumination level, subject locating transponder, body temperature, body activity, oxygen saturation of arterial blood, and sleeping orientation of infant.

In some embodiments, the capacitive type sensor is adapted to detect a variable capacitance between two serially connected capacitor plates and a body surface of the subject.

In some embodiments, the capacitive type sensor comprises two spaced conductive surfaces constituting capacitor plates which are applied to a substrate, said substrate being embedded within diaper absorbent core material such that said two spaced conductive surfaces face each other, said sensor adapted to detect a variable capacitance between said two spaced conductive surfaces.

Some embodiments of the present invention provide an apnea detector, comprising a curvature sensor adapted to detect a variable curvature of a subject body surface resulting from breathing patterns of a subject, and a detector unit in communication with said sensor for receiving an electrical signal from said curvature sensor which is indicative of said variable curvature and for emitting an alert signal when said received electrical signal is indicative of symptoms of apnea, said detector unit being attached to an article of clothing.

In some embodiments, the curvature sensor is selected from the group of a resistive strain gauge, a flexion sensor, a piezoelectric transducer, a sensor made of piezoresistive materials, a fiber optic element for measuring bending or stretching by means of optical refraction, diffraction, scattering, transmissivity, or polarization, and a force-sensitive resistor.

Some embodiments of the present invention relate to a monitoring system, comprising a detector unit for detecting one or more subject related parameters of interest and for emitting acoustical information after determining that a subject related parameter of interest has a predetermined status, and a stationary unit disposed within an audible range of said detector unit for receiving said emitted acoustical information.

Some embodiments of the present invention relate to a monitoring system, comprising (a) detector unit configured to detect a presence of a symptom of apnea; (b) an audio speaker for emitting an audio alert signal (i.e. for example, having predetermined characteristics) contingent upon the detected presence of a symptom of apnea; (c) a microphone in audible range of the audio speaker configured to detect sound and to generate an electrical signal descriptive of the detected sound; and (d) electrical circuitry (i.e. including any combination of digital or analog electrical hardware and/or software/executable computer code—for example, including one or more microprocessors, volatile and/or non-volatile memory, and/or executable code stored in memory) configured to analyze the electrical signal descriptive of the detected sound and to determine if the electrical signal descriptive of the detected sound matches the audio alert signal; and (e) an alert signal-emitting unit (e.g. including a speaker or visual display or digital computer configured to sent an electronic communication) configured, in response to the results of the analysis by the electrical circuitry, and contingent upon a positive matching (i.e. a determination that the electrical signal descriptive of the detected sound from the microphone does match the sound characteristics of the audio alert signal), to emit one or more additional alert signals.

In one example, the additional alert signal is an additional audio alert signal. In another example, the additional alert signal may be visual alert signal. In yet another example, the additional alert signal may be provided by an electronic communication such as an email, a text message (e.g. an SMS), or a communication via a packet switched and/or internet network. In yet another example, the additional alert signal may be a radio signal or infra-red data communication.

Some embodiments of the present invention relate to a monitoring system, comprising (a) detector unit configured to detect a indication of condition requiring care by a parent, guardian or medical professional; (b) an audio speaker for emitting an audio alert signal (i.e. for example, having predetermined characteristics) contingent upon the detected indication of the condition requiring care by a parent, guardian or medical professional; (c) a microphone in audible range of the audio speaker configured to detect sound and to generate an electrical signal descriptive of the detected sound; and (d) electrical circuitry (i.e. including any combination of digital or analog electrical hardware and/or software/executable computer code—for example, including one or more microprocessors, volatile and/or non-volatile memory, and/or executable code stored in memory) configured to analyze the electrical signal descriptive of the detected sound and to determine if the electrical signal descriptive of the detected sound matches the audio alert signal; and (e) an alert signal-emitting unit (e.g. including a speaker or visual display or digital computer configured to sent an electronic communication) configured, in response to the results of the analysis by the electrical circuitry, and contingent upon a positive matching (i.e. a determination that the electrical signal descriptive of the detected sound from the microphone does match the sound characteristics of the audio alert signal), to emit one or more additional alert signals.

Examples of conditions requiring care by a parent, guardian or medical professional include a presence or urine or feces, apnea and an abnormal body temperature.

In some embodiments, the stationary unit comprises a microphone, a microcontroller, means for filtering noise and tones that have a frequency outside a predetermined frequency band and for transmitting filtered signals to said stationary unit microcontroller, and means for generating an alert signal when said stationary unit microcontroller determines that the filtered signals are indicative of a predetermined audio signal emitted by the detector unit.

In some embodiments, the predetermined audio signal emitted by the detector unit is an acoustical signature.

In some embodiments, the alert signal generated by the stationary unit is a high-volume warning signal.

In some embodiments, the stationary unit further comprises a transceiver, the alert signal being a wireless signal transmitted by said stationary unit transceiver.

In some embodiments, the stationary unit comprises means for receiving, amplifying and emitting acoustical information enunciated by the subject.

In some embodiments, the stationary unit comprises a display in communication with the stationary unit microcontroller for outputting textual information indicative of the predetermined subject status.

In some embodiments, the stationary unit comprises one or more optical indicators in communication with the stationary unit microcontroller, illumination of each of said indicators being indicative of generation of an alarm signal.

In some embodiments, the stationary unit further comprises an external data interface for exchanging data with the stationary unit microcontroller.

In some embodiments, the monitoring system further comprises a portable unit in communication with the stationary unit transceiver via a communication network, said portable unit being accessible to the authorized attendant and adapted to enunciate acoustical information emitted by the stationary unit.

In some embodiments, a subject related parameter of interest detected by the detector unit is a characteristic breathing pattern value (CBPV).

In some embodiments, a capacitive type sensor in communication with the detector unit transmits an electrical signal thereto which is indicative of a variable capacitance CBPV.

In some embodiments, the capacitive type sensor comprises a conductive surface applied to a suitable diaper surface, said sensor adapted to detect a variable capacitance between said surface and a body surface of the infant.

In some embodiments, a curvature sensor in communication with the detector unit transmits an electrical signal thereto which is indicative of a variable curvature CBPV representing a variable curvature of a subject body surface.

In some embodiments, the system comprises an override unit in communication with the stationary unit transceiver and connected to a set-top box of a home entertainment system, said override unit adapted to interrupt the display of a program on said home entertainment system.

In some embodiments, the override unit is adapted to display a predetermined video frame on, or to enunciate voice information by means of, the home entertainment system.

In some embodiments, the alert signal is adapted to alert an authorized attendant that a subject related parameter of interest has a predetermined status.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a schematic cross sectional view of a diaper protectively attached to an infant body and having a pocket in which a detector unit is retained;

FIG. 2 is a schematic illustration of a detector comprising capacitive type sensors as it is attached to a diaper;

FIG. 3 is a schematic cross sectional view of a front section of a diaper provided with the detector ofFIG. 2, according to one embodiment of the invention;

FIG. 4A is a schematic illustration showing the electrical equivalent of each component of the detector ofFIG. 3, including the contribution of an infant body;

FIG. 4B is an electrical circuit corresponding toFIG. 4A;

FIGS. 5 and 6 illustrate a top view and a cross-sectional view from the side, respectively, of a detector unit;

FIG. 7 is a schematic cross sectional view of a front section of a diaper provided with the detector ofFIG. 2, according to another embodiment of the invention;

FIG. 8A is a schematic illustration showing the electrical equivalent of each component of the detector ofFIG. 7, including the contribution of an infant body;

FIG. 8B is an electrical circuit corresponding toFIG. 8A;

FIG. 9A is a perspective view of another embodiment of a capacitive type sensor;

FIG. 9B illustrates a cross-section of the capacitive type sensor ofFIG. 9A;

FIG. 10 is a schematic cross sectional view of a front section of a diaper provided with the sensor ofFIG. 9A;

FIG. 11 is a schematic cross sectional view of a front section of a diaper provided with a curvature type sensor;

FIG. 12A is a schematic illustration of the detector unit ofFIG. 11;

FIG. 12B is a perspective view from the rear of the detector unit ofFIG. 12A;

FIG. 13A is a magnified view of the connection between a curvature type sensor and a detector unit, according to one embodiment of the invention;

FIG. 13B is a schematic cross sectional view of a detector unit that is releasably attached to an article of clothing and provided with a curvature type sensor;

FIG. 13C is a schematic cross sectional view of a detector unit that is releasably attached to an article of clothing and provided with both a curvature type sensor and a capacitive type sensor;

FIGS. 14A-14E illustrate some embodiments related to a curvature sensor;

FIG. 15 is a schematic illustration of an infant monitoring system, according to one embodiment of the invention;

FIG. 16A is a block diagram of a detector unit, according to one embodiment of the invention;

FIG. 16B is a flow diagram of steps performed by a detector unit microcontroller to detect apnea;

FIG. 17 is a block diagram of a stationary unit, according to one embodiment of the invention;

FIG. 18 is a block diagram of a portable unit, according to one embodiment of the invention;

FIG. 19 is a schematic illustration of an infant monitoring system, according to another embodiment of the invention; and

FIG. 20 is a block diagram of an override unit, according to one embodiment of the invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention is a novel detector and monitoring system for apnea, and particularly for infant apnea. A detector unit, which is attached to a clothing article of the subject, is in communication with a sensor which may be ultra-thin, e.g. having a thickness of less than 1 mm. Due to its thin size and cost-effective manufacturing methods, such as being printed by conductive ink, hot foil stamping, conductive polymer tape, and vacuum metallization, the sensor is of low cost and can therefore be sold as a disposable product. The detector unit is integrated with a system, which will be described hereinafter, for instantly alerting an attendant once apnea is detected. Even though the apnea detector is in constant use, the subject is generally not exposed to close-proximity radio frequency radiation.

When the subject is an infant, a detector unit is embedded in, or otherwise attached to, a diaper, and due to its ergonomic configuration by which substantially no discomfort is caused to the infant, the detector unit may be in constant use throughout a 24-hour period, even when the infant is awake and not in a prone position. Since the detector is adapted to detect the breathing patterns of an infant who is distant from his bed or home, the onset of apnea conditions in addition to sudden infant death syndrome (SIDS), such as suffocation, can be advantageously determined.

FIGS. 1-10 illustrate one embodiment of the invention wherein the sensor is a capacitive type sensor which is adapted to measure a variable capacitance, for example between a plate of the sensor and a body surface of the infant. As the infant inhales and exhales, the thickness of an air gap between the diaper and the body surface of the infant periodically changes, and therefore the sensed capacitance correspondingly changes, indicating that the infant has a normal breathing pattern.

As schematically shown inFIG. 1,diaper10 comprised of afront section2 and arear section5 is formed with apocket8 in which the detector is retained. Whendiaper10 is protectively attached toinfant body12, the internal organs of which are not illustrated,front section2 andrear section5 ofdiaper10 are connected by means ofadhesive strips7 andvariable air gap14 exists betweendiaper10 andinfant body12. A change in the thickness ofair gap14 is generally caused by the expansion and contraction of the chest wall, and is also caused by the compression offront section2 ofdiaper10.

Sensors

16 and17 retained infront section2 detect the expansion and contraction of the chest wall.

FIG. 2 schematically illustrates a detector generally designated bynumeral6, which comprisesapnea detector unit20A and

sensors

16 and17.Detector unit20A is retained withinpocket8 ofdiaper10 and secured thereto by means ofadhesive tab13.Apnea detector unit20A is interposed between, and in electrical communication with, two

conductive surfaces

16 and17 constituting capacitor plates, which are printed preferably, but not limitatively, by conductive ink or hot foil stamping, as well known to those skilled in the art.Detector unit20A may also be in communication with one or moreadditional sensors19 that are adapted to detect infant related parameters of interest, such as urine detection, feces detection, infant heartbeat detection, ambient temperature and humidity, illumination level, body temperature, body activity, infant locating transponder, and sleeping orientation of infant.Detector unit20A may also be in communication with an electronic device, such as an audio monitoring device, and may be provided with means for logging infant activity events.

Plates

16 and17,additional sensors19, and monitoring equipment are connected todetector20A by means of correspondingelectrical contacts21 provided in the casing ofdetector20A, or, alternatively by means of capacitive coupling through a layer ofdiaper10, as will be described hereinbelow.Pocket8 is preferably formed with one ormore holes22. Ahole22 may be used, for example, to enhance acoustic conductance of a beeper, to facilitate access to a deactivation button, or to improve the viewability of light emitting diode (LED) indicators.

FIG. 3 illustratesfront section2 of a diaper, which comprisesouter layer3,absorbent core9, andinner layer18, showing the connection in magnified cross sectional view between

plates

16 and17 anddetector unit20A.Detector unit20A is placed withinpocket8A, which is welded or bonded to the exterior face of the waterproofouter layer3 of the diaper.

Plates

16 and17, which are printed on, or attached to, the inner face ofouter layer3 and in contact withabsorbent core9 of the diaper, are capacitively coupled todetector unit20A by means ofcoupling pads23A-B printed on the inner face of diaper outer layer3 (hereinafter “diaper side coupling pads”) and coupling pads24-B attached to the casing ofdetector unit20A (hereinafter “detector side coupling pads”).Conductor26 connectsplate16 and diaperside coupling pad23A, andconductor27 connectsplate17 and diaperside coupling pad23B.

FIGS. 4A-B schematically illustrate the electrical equivalent of thecircuit35 defined by the apparatus of this embodiment. As shown,capacitance31 andcapacitance32 are the variable capacitances between

plates

16 and17, respectively, andinfant body12, wherein the variable capacitance is dependent on the instantaneous thickness ofabsorbent core9 of the diaper and of air gap14 (FIG. 3).Resistance34 is the equivalent resistance ofinfant body12.Capacitance36 is the fixed capacitance between

coupling pads

23A and24A, whilecapacitance37 is the fixed capacitance betweencoupling pads23B and24B.Equivalent circuit35 comprisesdetector20A, fixedcapacitance36,variable capacitance31,resistance34,variable capacitance32, and fixedcapacitance37, which are all connected in series.

As well known, the combined capacitance of capacitors in series is the reciprocal of the sum of the reciprocal of the capacitances. In order to be able to accurately detect and transmit the instantaneous capacitance between a capacitor plate and the infant body, which is indicative of whether the infant has normal breathing patterns, the value of the fixed capacitance therefore is preferably, but not necessarily, greater than the value of the variable capacitance, which is serially connected therewith. The equivalent capacitance ofcircuit37 is therefore dominated by

variable capacitances

31 and32, whileresistance34 does not considerably affect the capacitance measurement.Detector unit20A is adapted to sense the total equivalent capacitance ofcircuit37, and by comparing the total equivalent capacitance over time, i.e. with respect to several breaths or with respect to previous measurements, it is able to determine whether the infant has normal breathing patterns. By comparing the total equivalent capacitance with a nominal value, which is generally empirically measured,detector20A may also advantageously determine whetherair gap14 is of an average value, much smaller than the nominal value indicating that the diaper is loosely attached to the infant, or much greater than the nominal value indicating the diaper is attached to the infant in an excessively tight manner, whereupon a parent is alerted.

In order to allow for manufacturing tolerances and mechanical movement of the detector within the pocket, it is desirable that diaperside coupling pads23A-B be of a larger size than the corresponding detectorside coupling pads24A-B, so that the entire area of a diaper side coupling pad overlap the corresponding detector side coupling pad, so that the coupling capacitance between a diaper side coupling pad and the corresponding detector side coupling pad remains constantly high.

FIGS. 5 and 6 illustrate a top view and a cross-sectional view from the side, respectively, of adetector unit20A. The components ofdetector20A are mounted withincasing41, which may be made of plastic material, while being sealed and water resistant.Casing41 is ergonomically configured with a thin and curvilinear structure that is shaped without any sharp protrusions, so that when retained inpocket8A (FIG. 3), casing41 does not cause any discomfort to the infant when a portion of the infant body is pressed thereagainst.Arcuate side portions38 ofcasing41, which may contact pocket8A (FIG. 3) by means of opposed side recessed

portions

54 and55 for engaging complementary protrusions of the pocket, are integrally formed withunderside39 and withupper portion42 thereof.

Detector unit

20A comprises amicrocontroller43, a recessedbutton45 for activating or deactivatingmicrocontroller43, for silencing an enunciated alarm signal, or for any other desired user input, upon depression of an overlying region46 ofupper casing portion42, anenunciator47, e.g. of the piezoelectric or electromagnetic type, for audibly alerting a parent when symptoms of apnea are detected and placed beneath athin layer48 ofupper casing portion42 to minimize the attenuation of the alarm signal, abattery49, e.g. of the CR2032 coin cell type, a flexible or rigid printedcircuit board51 electrically connected tomicrocontroller43,button45,enunciator47, andbattery49, andcoupling pads24A-B externally attached tounderside39. A portion ofcoupling pads24A-B protrudes throughunderside39 and is connected withconductors53A-B, respectively, which in turn are electrically connected with printedcircuit board51. One or more light, LED, or any other suitable optical indicator, in communication withmicrocontroller43 may be used to visually alert a parent if casing41 is not opaque.Contacts57A-B for connecting one or more additional sensors are also connected tounderside39.

FIG. 7 illustratesfront section2 of a diaper, which comprisesouter layer3,absorbent core9, andinner layer18, showing the connection in magnified cross sectional view between

plates

16 and17 anddetector unit20A.Detector unit20A is placed withinpocket8B, which is welded or bonded to the inner face of the waterproofouter layer3 of the diaper. Althoughpocket8B is embedded withinabsorbent core9, it can be easily accessed by means of a suitable incision effected in diaperouter layer3.

In this embodiment,detector unit20A is directly connected to

sensor plates

16 and17.Detector side contacts58A-B attached to the exterior face of casing underside39 (FIG. 6) ofdetector20A are electrically connected todiaper side contacts59A-B, respectively.Contacts59A-B in turn are electrically connected to

plates

17 and16, respectively by means of conductors61A-B, respectively, which are attached to the inner face ofouter layer3, extending from a diaper side contact to a corresponding plate. The electrical connection between a detector side contact and a corresponding diaper side contact is sustained by minimizing the clearance between the walls ofpocket8B and the casing ofdetector20A, so that the walls ofpocket8B will apply a sufficiently high outwardly directed force, i.e. towardsouter layer3, todetector unit20A, and by providing a suitable texture and/or structure to thecontacts58A-B and59A-B.

FIGS. 8A-B schematically illustrate the electrical equivalent of thecircuit67 defined by the apparatus of this embodiment. As shown,capacitance31 andcapacitance32 are the variable capacitances between

plates

16 and17, respectively, andinfant body12, wherein the variable capacitance is dependent on the instantaneous thickness ofabsorbent core9 of the diaper and of air gap14 (FIG. 3).Detector unit20A is connected to capacitance31 by means of contacts58B and59B, and is connected to capacitance32 by means of

contacts

58A and59A. Thusequivalent circuit67 comprisesdetector unit20A,variable capacitance31,resistance34, andvariable capacitance32, which are all connected in series. The resistance ofinfant body12 andcontacts58A-B and59A-B, which are connected in series, do not significantly affect the measurement of the equivalent capacitance.

FIG. 9A illustrates another embodiment of a capacitive type apnea sensor, which is designated bynumeral70. In the capacitive type sensor ofFIG. 9A, the capacitance between capacitor plates is sensed, and an apnea alarm responds to variations of the sensed capacitance.

In some embodiments,sensor70, which is shown partially folded, comprises aflexible substrate72, e.g. made of paper, card or thin plastic, and two spaced rectangular

conductive elements

73 and76, which constitute capacitor plates, applied to the same face ofsubstrate72 by conductive ink, hot foil stamping, bonding, or vacuum metallization.Substrate72 is folded to define aninner portion65 that includeselement73, anouter portion69 that includeselement76, and acrease67 interposed betweeninner portion65 andouter portion69.

Conductive strip

74 extends fromconductive element73 toouter portion69 without contactingelement76, andaperture75 is bored at the terminal end ofstrip74. Curvedconductive appendage77 extends fromelement76, andaperture78 is bored therein. An electrically insulating layer may be applied to

conductive elements

73 and76,strip74, andappendage77.

It will be appreciated thatsubstrate72 may be folded in any other desired fashion, so that in such a configuration

conductive elements

73 and76 may be applied to different faces ofsubstrate72.

In some embodiment, it is possible to deploy the

capacitor plates

73 and76 so that mechanical force transferred from the surface of the patient during his/her breathing cycle cyclically modifies a distance between

plates

73 and76. For the present disclosure, a “transfer of mechanical force” excludes the case of hydraulic and/or pneumatic means. In this example, surface of the subject's body moves up and down during breathing, increasing and decreasing upward pressure from the body surface to one or both of the plates. This increasing and decreasing outward pressure from the surface/skin of the subject may mechanically move one or more ‘capacitive plates’ closer together or farther apart, cyclically modifying the capacitance between the plates according to the breathing cycle. In some embodiments, it is possible to monitor the temporal variance of the capacitance, and when the capacitance between the capacitor plates or its temporal variance indicates a symptom of apnea, to generate an alarm signal.

In one non-limiting example, at least a portion of an article clothing (for example, a diaper) is located between or “sandwiched between” the

plates

73 and76. In another example, some sort of sponge is located between or “sandwiched between” the

plates

73 and76. In yet another example, there is no ‘material’ between

plates

73 and76 other than air.

It is appreciated that the capacitor “plates”73 and76 are not required to be flat and/or rectangular as shown in the figure.

Some embodiments of the present invention relate to a method of detecting apnea that is carried out at a time when

capacitive plates

73 and76 are mechanically coupled and/or deployed to an article of clothing worn by the subject (e.g. including but not limited to a diaper). The method comprises the steps of: (a) for first73 and second76 capacitive plates, each capacitive plate being deployed to the article of clothing, sensing a capacitance between the first and second capacitive plates; (b) analyzing time variations of one or more of the sensor-output electrical signals to determine if the time variations are indicative of a symptom of apnea in the subject; and (c) generating an apnea alert signal that is contingent on the results of the apnea determining.

FIG. 9B illustrates a cross-section of the capacitive type sensor ofFIG. 9A. As illustrated inFIG. 9B, the outward force from the subject'sbreathing260 may cyclically increase and decrease in value (even reach a value of zero or a negative value). This force from the subject's body (e.g. the surface or skin) is transferred mechanically (i.e. see the arrow of260) without any need for pneumatic or hydraulic force-transfer means to one or both of the

capacitive plates

73,76. In some embodiments, an additionalinward force261 in reaction to theoutward force260 may also act upon (i.e. mechanically without any need for pneumatic or hydraulic force-transfer means) one or both

plates

73,76 thereby influencing the capacitance between the plates which may be sensed and used to apnea detecting.

As shown inFIG. 10,sensor70 is embedded withinabsorbent core9 of a diaper in such a way thatinner portion65 andouter portion69 face each other.Outer portion69 of the substrate may be attached toouter layer3 of the diaper andinner portion65 of the substrate may be attached toinner layer18 of the diaper.Detector unit20B, in which are housed the same components asdetector unit20A (FIG. 6), is coupled tosensor70 such that it is mounted externally to diaperouter layer3.Detector unit20B may be coupled tosensor70 by means of metallic rivets (not shown) in engagement withapertures75 and78 (FIG. 9A) and in electrical communication with circuit board51 (FIG. 6). The rivets also facilitate attachment ofouter portion69 of the substrate toouter layer3 of the diaper. Alternatively, the underside of the casing ofdetector unit20B may be provided with abacking62 made of Velcro® (hook and loop fasteners), which is adapted to be coupled withcomplementary material64 attached to the outer face of diaperouter layer3, and withelectromechanical snap connectors63A-B, which are adapted to engage with complementary terminals, respectively, attached toouter layer3 and in electrical communication with a corresponding conductive element. If so desired, the Velcro® material may be afforded conductive properties. It will be appreciated that adetector unit20A provided with capacitive coupling pads, as illustrated inFIG. 6, may also be employed.

As the infant inhales and exhales, the thickness ofair gap14 diaperinner layer14 andinfant body14 periodically changes, causing substrateinner portion65 to be displaced and the absorbent core material to be compressed. The displacement of substrateinner portion65 with respect to the substantially stationary substrateouter portion69 results in a varying capacitance corresponding to that of the absorbent core material interposed between

conductive elements

73 and76, indicating that the infant has a normal breathing pattern.

With reference toFIG. 9A, an additional sensor, such as a urine and/or feces detector, in addition toapnea sensor70, can be applied tosubstrate72. The additional sensor comprises

electrodes

81 and82, which are also applied tosubstrate72 and bored with

apertures

83 and84, respectively, in electrical communication with the detector. Apertures83 and84 may be arranged such that they are collinear with

apertures

75 and78 of the conductive elements. To enhance the sensing of bodily excretions,substrate72 may be produced from material having superior liquid-wicking and electrical conduction properties.

Electrodes

81 and82 may be applied to substrateinner portion65 as shown, or alternatively, to substrateouter portion69.

FIGS. 11-14 illustrate another embodiment of the invention wherein the apnea sensor is adapted to measure periodic changes in the curvature of a body surface of an infant. Periodic changes in the curvature of the body surface are indicative that the infant has normal breathing patterns.

As shown in the example ofFIG. 11,sensor95 is adapted to measure the curvature C ofbody surface92 of an infant.Sensor95 is in communication withdetector unit20C, which is shown to be attached tofront section2 of a diaper by means of abacking62 made of Velcro® andadhesive strips7.Sensor95 may include a resistive strain gauge, a flexion sensor, a piezoelectric transducer, a sensor including one or more of piezoresistive materials, a fiber optic element for measuring bending or stretching by means of optical refraction, diffraction, scattering, transmissivity, or polarization, a force-sensitive resistor, or any other sensor well known to those skilled in the art. As will be discussed below, the output ofcurvature sensor95 is significantly influenced and/or governed primarily by perpendicular forces onsensor95.FIG. 12A illustrates a schematic, cross sectional view ofdetector unit20C, andFIG. 12B illustrates a perspective view from the rear ofdetector unit20C.

The particular example ofFIGS. 12A-12B relate to a ‘hybrid detector’ that include both (i) elements for detecting capacitance (e.g.105A,105B) (ii) as well as a curvature sensor (for example, which outputs a resistance parameter that is governed by a measured curvature). In experiments conducted by the present inventors, it has been found that the use of the multiple sensors (i.e. capacitance and curvature sensors) may produce a device that is more accurate than a device that includes only one type of sensors. Nevertheless, it is appreciated that there is no requirement for both types of sensors to be present, and some embodiments relate to the case where a curvature sensors is provided without any required capacitance sensors (or vice-versa—i.e. where the capacitance sensor is provided without any required curvature sensor).

For the example ofFIGS. 12A-12B,curvilinear housing102 ofdetector unit20C is configured with a winglike bilateral symmetry, and is provided with an elevatedcentral portion107 and relativethin extremities108A-B. Microcontroller43, recessedbutton45, enunciator,47,battery49, andflexible circuit board101 are housed withincentral portion107. The winglike configuration ofhousing102 advantageously increases the engagement area of Velcro® backing62, and furthermore, enables attachment toextremities108A-B byadhesive strips7, as shown inFIG. 11. The winglike configuration ofhousing102 also provides flexibility in terms of sensor selection.Flexible capacitive plates105A-B of increased area can be embedded within, or printed on aninner surface106 of,extremities108A-B, respectively, for enhanced sensitivity. In the particular example ofFIG. 12A, a curvature sensor such as aresistive strain gauge95A may be deployed withincentral portion107, such as printed onflexible circuit board101 as shown. Alternatively, resistive strain gauges may be housed withinextremities108A-B, respectively. Velcro® backing62 may be applied to the entireinner surface106, or a portion thereof.

It is appreciated that strain gauges may measure a force or stress caused by ‘pulling’ on the ends ofstrain gauge95A (i.e. parallel tensile stress)—therefore, thestrain gauge95A is not, by itself acurvature sensor95 which measures ‘perpendicular forces’ that are perpendicular to a tangent293 around the circumference of the patient and/or perpendicular to a “flat surface” the substantiallyflat curvature sensor95. Therefore, in the example ofFIG. 12A, one or more mechanical elements may be provided to ‘translate’ radially-outward force that is substantially perpendicular to a length of the strain gauge and/or perpendicular to a vector connecting stretchable ends89A,89B into a tension and/or compression that is substantially parallel totangent293.

In one example, strain gauge is embedded withincentral portion107 which is semi-rigid or substantially rigid (but not completely rigid). In this example, becausestrain gauge95A is embedded within the semi-rigid or substantially rigid material, radially outward force caused by the subject's breathing that is perpendicular to293 and/or perpendicular to the substantially flat surface ofstrain gauge95A is ‘diverted around’ or ‘transferred to’ ends89A and89B. Thus, the semi-rigid or substantially rigid material converted a force perpendicular to the substantially flat surface to one which ‘pulls the ends’ of this substantially flat surface and can then be measured bystrain gauge95A—thus, strictly speaking,strain gauge95A is not by itself acurvature sensor95 but rather is a part of acurvature sensor95.

In yet another example, anend89A of strain gauge is attached to “flexible” printed circuit board101 (which is not that ‘flexible’ and which, in reality, is known to be at least semi-rigid), and flexible printedcircuit board101 plays a roll in converting the outward force perpendicular totangential axis293 into force alongtangential axis293—for example, according to a mechanism similar to the mechanism explained below with reference toFIG. 14E.

In order to support connectivity to other disposable sensors such as urine detection electrodes, selected regions of Velcro® backing62 may have electrically conductive properties. Alternatively, adhesive strips7 (FIG. 11) may be conductive, so as to connect a sensor to external contacts provided onhousing102.

InFIG. 13A, the curvature sensor is shown to be a flexion sensor95B, such as one manufactured by Flexpoint Sensor Systems, Inc., Draper, Utah, USA, which is adapted to convert the bending of a substrate into a variable resistance.Detector unit20D is retained withinpocket8A attached to the outer face of diaperouter layer3, and is in communication with flexion sensor95B by means of conductor91 connected to flexion sensor95B andcontacts93A-B ofdetector unit20D, which are in communication with conductor91. By mounting, or directly printing, flexion sensor95B on asemi-flexible insert97 attached to the inner face of diaperouter layer3, any change in the curvature of the diaper, such as a result of breathing movement, can be sensed as a periodic change in resistance.

FIG. 13B illustrates adetector unit20D for determining when an adult subject is suffering from apnea.Detector unit20D comprisescurvature sensor95,e.g. sensor95A ofFIG. 12A or sensor95B ofFIG. 13A, and is adapted to measure the curvature ofbody surface94 of anadult96.Housing102A ofdetector unit20D may be configured with a winglike bilateral symmetry as shown, or with any other suitable configuration.Housing102A may be releasably attached to an article ofclothing111, such as an upper portion of pants, pajamas or underwear, or a lower portion of a shirt, by means of

clips

110A and110B attached toinner surface106A ofhousing102A. Alternatively,housing102A may be releasably attached to article ofclothing111 by means offlexible magnets109A-B, e.g. polymer magnets, of opposite polarity.Magnet109A is placed betweenclothing article111 andbody surface94, andmagnet109B is attached to, or integral with,inner surface106A, so that

magnets

109A and109B will be coupled together whileclothing article111 is positioned therebetween to ensure thatbody surface94 will be spaced less than a predetermined maximum distance from housinginner surface106A.

InFIG. 13C, adult apnea detector unit20E configured withhousing102A comprises bothcurvature sensor95 andflexible capacitive plates105A-B. It will be appreciated that an adult apnea detector unit may be provided solely with a capacitive type sensor. Similarly, an adult apnea detector may be employed in conjunction with any of the embodiments described hereinabove.

InFIG. 14A, curvature sensor may be deployed together with semi-rigid or substantially rigid (but not completely rigid) substrate264 (for example, made of semi-rigid or substantially rigid plastic). In the example ofFIG. 14A,curvature sensor95 is “above” the semi-rigid or substantially rigid (but not completely rigid) substrate264 (or farther from the skin)—alternatively,curvature sensor95 may be “below” the semi-rigid or substantially rigid (but not completely rigid)substrate264.

As it shown inFIG. 14A, the length of thesubstrate264 along tangential axis14A may exceed the length of curvature sensor—for example, by a factor of at least 20% or 30% or 40% or 50% or 75% or 100% or any number. Becausesubstrate264 is not completely rigid,outward force262 due to the subject's breathing will deformsubstrate264 and modify the curvature of substrate264 (for example, at least in part due to

reactive forces

263A,263B). Becausesubstrate264 is not flexible but is semi-rigid or substantially, forces perpendicular to a substantially flat surface of substrate264 (i.e. even at locations withinsubstrate264 that are ‘far’ from curvature sensor95) may cause a force perpendicular to a substantially flat surface ofcurvature sensor95 to deform curvature sensor. Thus, the semi-rigid or substantiallyrigid substrate264 may be said to amplify the signal offorce262.

In some embodiments, the electrical resistance parameter output bycurvature sensor95 varies as a function of time according to the breathing cycle. There is a certain magnitude in change of the electrical resistance parameter as thecurvature sensor95 senses a cyclical change in curvature. In some embodiments, (for example, related to acurvature sensor95 that whose length (e.g. along tangential axis293) is at most 200% or 150% or 100% or 85% or 65% or 50% of a length (e.g. along tangential axis293) of semi-rigid or substantially rigid substrate264), the presence of the semirigid or substantially rigid substrate264 (i.e. deployed so thatsubstrate264 is between the subject's skin andcurvature sensor95 as shown inFIG. 14A or deployed so thatcurvature sensor95 is between the subject's skin and substrate264) significantly contributes to variations in the output electrical resistance parameter outputted by curvature sensor. Thus, in some embodiments, the absence of the semirigid or substantiallyrigid substrate264 causes much smaller output resistance parameter variations output by curvature sensor95 (i.e. output resistance parameter variations whose magnitude is at most 50%, or at most 40%, or at most 10% of a magnitude in the presence of semirigid or substantiallyrigid substrate264 during the baby's breathing cycle.

As shown inFIG. 14B, in some embodiments,sensor95 has a ‘length’ ofcurvature sensor95 along a circumference of the subject (i.e. along tangential axis293) and perpendicular to anelongate axis291 of the subject. In some embodiments, this ‘length’ is less than 50% or 45% or 40% or 35% or 30% of a circumference of272 the subject at the location ofcurvature sensor95. In some embodiments, the length of curvature sensor95 (i.e. along an elongate axis and/or axis293) is at most 25 cm.

FIGS. 14C-14D relate to the definitions ‘local outward force’ in contrast to any ‘outward force’ which is caused by the breathing of the subject. The ‘local outward force’ relative tocurvature sensor95 is outward force at the location where the curvature sensor is deployed above the surface of the subject. Thus, inFIG. 14C (i.e. wherecurvature sensor95 is deployed above the article of clothing AOC295) and inFIG. 14D (i.e. wherecurvature sensor95 is deployed below the article of clothing AOC295) the forces identified by999A-999E are ‘local outward forces’ along a vector which intersects a surface of thecurvature sensor95. In contrast, forces identified by999F-999N are non-local. In some embodiments, the variations of the electrical resistance parameter which is output by curvature sensor during the breathing cycle are governed primarily by variations of the local outward forces during the breathing cycle—for example, which reach a maximum when the subject is inhaling and decrease when the subject is exhaling. In some embodiments, time variations in the sensed ‘local outward forces’ contribute at least 30% or 50% or 70% or 90% to the total variations of the output resistance parameter during the breathing cycle.

FIG. 14E relates to yet another example wherecurvature sensor95 may include astrain gauge95A. Thus, inFIG. 14E,element264 is a semi-flexible or substantiallyflexible substrate264,force262 is an outward force from the subject due to breathing,

forces

263A and263B are reactionary inward forces from the semi-flexible substrate in reaction to force262. The

inward forces

263A,263B cause thesubstrate264 to bend and modify its radius of curvature, inducingtension266 orcompression267 in a direction substantially parallel toaxis293. This tension or compression may be measured bystrain gauge95A which is a part ofcurvature sensor95. Without the presence of a semi-flexible or substantiallyflexible substrate264 as described above,strain gauge95A by itself is not acurvature sensor95.

In some embodiments, whencurvature sensor95 is subjected to a change in curvature from flat radius of curvature of 20 cm, the resistance parameter output bycurvature sensor95 changes by larger a percentage than when subjected to a change in tensile or longitudinal stress (e.g. alongaxis293 or along an axis substantially parallel to a substantially flat surface of curvature sensor95) from relaxed to a tensile force of 10 N.

In some embodiments,curvature sensor95 is not part of a ‘closed mechanical loop’ which closes upon itself to provide an inward force throughout a majority or a substantial majority (i.e. at least 60% or 70% or 80% or 90% or 95% of acircumference272 of the subject) in response to an outward force of breathing. Instead,curvature sensor95 may be part of a flexible article of clothing and therefore does not hinder breathing.

FIG. 15 illustrates a monitoring system generally designated bynumeral120, according to one embodiment of the present invention.System120 comprisesdetector unit20,stationary unit130 in communication withdetector unit20, andportable unit150 accessible to a parent or to any other authorized attendant and in communication withstationary unit130.Detector unit20 is embedded indiaper10, or otherwise attached to an article of clothing, preferably in communication with an apnea sensor, as described hereinabove, and optionally with one or more additional sensors adapted to detect infant related parameters of interest, and may be configured asdetector unit20A (FIG. 6),20B (FIG. 10),20C (FIGS. 11-12),20D (FIG. 13), or any other desired configuration.

As opposed to prior art detector units that are embedded or otherwise attached to a diaper and that remotely transmit sensed data by means of radio frequency (RF) waves, thereby exposing the infant to harmful levels of RF radiation,detector unit20 advantageously transmits acoustical information tostationary unit130.Detector unit20 emits acoustical information A after determining that a subject related parameter of interest has a predetermined status, as sensed by one of the sensors in communication therewith.Stationary unit130, which is supported by a selected structure, such as a bed post or a table, and is disposed within an audible range ofdetector unit20, receives emitted acoustical information A and determines that it is indicative of a predetermined subject parameter status. A wireless signal S indicative of the determined subject parameter status is then transmitted toportable unit150 via any suitable data network, so that the attendant will take corrective actions. A subject parameter status may be that a diaper is overly wet or overly tight, or that the detector unit battery is drained. When the determined subject parameter status requires immediate attention, such as when symptoms of apnea are detected,stationary unit130 enunciates a warning signal W significantly louder than acoustical information A and displays textual information ondisplay122 and/orLEDs124 become illuminated, and the authorized attendant is immediately alerted by means ofportable unit150. If so desired,detector unit20 may be any dedicated unit for detecting a subject related parameter of interest that can transmit acoustical information tostationary unit130, and optionally,stationary unit130 need not be in communication with a portable unit.

When the subject is an adult who does not require an attendant, a portable unit may be unnecessary, The enunciation of acoustical information A bydetector unit20 or of warning signal W bystationary unit130 will advantageously stimulate the subject to awake during manifestation of sleep apnea.

FIG. 16A illustrates a block diagram ofdetector unit20.Detector unit20 comprisesmicrocontroller43, e.g. the PIC-16xxx family of microcontrollers, which is provided withmemory device112, such as Read-Only Memory (ROM) or Non-Volatile Random Access Memory (NVRAM), for storing therein firmware algorithms such as an algorithm for the detection of apnea, as will be described hereinafter, Random Access Memory (RAM)114 including registers,event log116, such as based on NVRAM, anddigital signal processor118.Microcontroller43 receives input fromsensors115, including apnea sensors and additional sensors, such as urine sensor, feces sensor, ambient temperature sensor, humidity sensor, illumination level sensor, body temperature sensor, body activity sensor, oximeter, and infant sleeping orientation sensor, fromanalog interface119, Analog to Digital (A/D)converter121, and frombattery level detector123 connected tobattery49.Microcontroller43 is also in communication withdeactivation button45,display122,LEDs124,enunciator125,timer127, e.g. an interrupt timer, andexternal data interface129.Detector unit20 is adapted to couple with dockingport135, which may be integrally attached to the stationary unit or may be an independent docking unit, to facilitate the retrieval of data stored in event log116 by means ofdata interface129, to chargebattery49, or to upgradefirmware112.

FIG. 16B illustrates an exemplary method for detecting apnea. The microcontroller of the detector unit receives signals from the corresponding apnea sensor, whether a capacitive type sensor or a curvature sensor as described hereinabove. The received signals are representative of a value of a parameter that is characteristic of the breathing patterns of a subject. The microcontroller processes the received characteristic breathing pattern values (CBPVs) by means of the firmware algorithm stored in the memory device and determines whether the CBPVs are indicative of the onset of apnea.

To minimize the consumption of battery power, the microcontroller operates at a low periodic sampling rate of e.g. 1 sample per 250 msec when receiving CBPVs, and is in a low-power inactive mode during the interval between two sampling operations. Even though the microcontroller is in the inactive mode, the LEDs of the detector unit are generally periodically lit to indicate that the detector unit is in operation. It will be appreciated, however, that the microcontroller can also be continuously operated, if so desired. The microcontroller is initialized during initial powerup, and is able to differentiate setup operations between the initial powerup time and a periodic powerup time. A register may be used as a counter, and the counter is decremented instep140 after each subsequent time interval, e.g. 1 msec, has elapsed. At the predetermined periodic powerup time, a CBPV is received instep142. In addition to CBPVs, other characteristic parameter values for the performance of auxiliary operations such as urine detection and battery level detection are received by the microcontroller at predetermined slower sampling rates, in order reduce battery consumption.

The RAM of the microcontroller has three registers: (1) a shift register in which is stored a plurality of data bits representative of a previously stored CBPV (“status register” or STRG), (2) a register in which is stored data bits representative of a maximum CBPV received during inhalation (“inhalation register” or INRG), and (3) a register in which is stored data bits representative of a minimum CBPV received during exhalation (“exhalation register” or EXRG).

The status register serves as a means for comparing the breathing patterns of the subject without need of calibration, to determine whether the onset of apnea has been detected. The least significant bit (LSB) of the shift register is set to a value of 0 after determining that the presently received CBPV is greater than the previously received CBPV, indicating that the subject is inhaling. Conversely, the LSB of the shift register is set to a value of 1 after determining that the presently received CBPV is less than the previously received CBPV, indicating that the subject is exhaling. When a LSB is stored, all of the previously stored data bits are shifted to the left and the previously stored most significant bit (MSB) is deleted. By retaining all previously stored data bits during a predetermined period of time, e.g. 10 seconds, a comparison can be made with the data bits stored in the status register to determine whether the subject is exhibiting a regular breathing pattern. That is, a regular breathing pattern is exhibited when the subject periodically inhales and exhales. However, if all the stored data bits in the status register are identical, an abnormal breathing pattern is being exhibited and a corrective action is needed.

Accordingly, the microcontroller determines instep144 whether the LSB of the status register is set to 0. If so, the microcontroller determines instep146 whether all data bits stored in the status register are 0. If all data bits stored in the status register are 0, the subject has been found not to be exhaling during the period equal to the product of number of bits and the interval between two sampling operations, whereupon an alarm flag is set instep148.

If some of the data bits stored in the status register are 1, indicating that a regular breathing pattern is being exhibited, the presently received CBPV is compared with the maximum CBPV stored in the inhalation register instep151. If the presently received CBPV is greater than the difference between the maximum CBPV stored in the inhalation register and a characteristic delta value, which takes into account hysteresis during data acquisition, such as a result of movement of the infant or partial inhalation, the LSB of the status register is set to 0 instep152, the other bits thereof are shifted to the left and the MSB thereof is deleted. If the presently received CBPV is greater than the maximum CBPV stored in the inhalation register as determined instep154, the inhalation register is set to CBPV instep156. However, if the presently received CBPV is less than the difference between the maximum CBPV stored in the inhalation register and the characteristic delta value, a change in the breathing pattern is being exhibited and the LSB of the status register is set to 1 in step158, whereupon the exhalation register is set to CBPV instep160.

After determining whether the inhalation register needs to be set with the CBPV instep154 or performing

steps

156 or160, a determination is then made instep162 whether the alarm flag has been set. If the alarm flag has been set, a warning sound, which is preferably an acoustical signature defined by a predetermined number of tones each of which having a predetermined duration and frequency, is enunciated instep164. If the deactivation button is depressed instep166, the warning sound will not be enunciated instep168.

This method is similarly performed for exhalation in

steps

176,178,181,182,184,186,188,190 when the LSB of the status register is set to 1 instep144. The microcontroller then returns to the inactive mode instep170 for another interval prior to another sampling operation.

FIG. 17 illustrates a block diagram ofstationary unit130.Stationary unit130 comprisesmicrocontroller195, which is provided withmemory device192, such as Read-Only Memory (ROM) or Non-Volatile Random Access Memory (NVRAM), and Random Access Memory (RAM)194 including registers,microphone197 for detecting an audio signal, e.g. an acoustical signature, emitted byenunciator125 of detector unit20 (FIG. 16A),amplifier198, and audio bandpass filter (BPF)199.BPF199 receives an amplified audio signal and filters unwanted noise and tones that have a frequency outside the predetermined frequency band of the detector unit enunciator. The filtered signals are transmitted as digital inputs tomicrocontroller195. Whenmicrocontroller195 determines that the filtered signals are indicative of a predetermined audio signal emitted by the detector unit, a high-volume warning signal W is generated by means ofamplifier201 andspeaker202, to audibly alert an authorized attendant that a corrective action needs to be urgently taken. Alternatively, or in addition,microcontroller195 may output textual information to display204, e.g. a liquid crystal display (LCD), or tooptical indicators205, such as an LED.

Microcontroller

195 receives inputs from one or more user initiatedcontrols211, such as a dial, button or switch.Stationary unit130 is powered bypower supply212 and a suitable power source, such asbattery214 or by means of alternating current (AC).Battery214 may be rechargeable and serve as a backup during an outage or shortage of power supplied from the AC mains.

Data may be exchanged withmicrocontroller195 by means ofexternal data interface219.Stationary unit130 is adapted to couple with dockingport217, to facilitate the retrieval of data by means ofdata interface219, to chargebattery214, or to upgrade firmware stored inmemory device192. Data interfacing circuits may interface betweendocking port217 andmicrocontroller195. These data interfacing circuits may also be connected to a universal serial bus (USB), a data network such as Ethernet, or to an Internet service provider such as by an asymmetric digital subscriber line (ADSL) line. Such data exchange enables the analysis of event log116 (FIG. 16A), the upgrading offirmware192 and/or the updating of configuration information and user settings.Docking port217, which may be integrally attached tostationary unit130, may be the same docking port to which the detector unit is coupled, and therefore is adapted to charge detector unit battery49 (FIG. 6) and to update detector unit firmware112 (FIG. 16A).

When a portable unit is employed,microcontroller195 also comprises atransceiver205 for transmitting a wireless signal S₁over a cellular network and atransceiver206 for transmitting an RF signal S₂. A signal S₁or S₂, depending on with which network the portable unit is in communication, is transmitted to the portable unit when a corrective action needs to be taken. Alternatively, a signal S₁may be transmitted over a cellular network to a predetermined number to alert the authorized adult who is not in an audible range ofstationary unit130 or to an emergency medical service, such as when the infant is exhibiting symptoms of SIDS, particularly sleep apnea. Alternatively, a signal S₁or S₂may be transmitted to a home automation system, for activating a device to alert an authorized attendant who may be asleep or does not respond to a high-volume warning signal W or to a cellular telephone call. The home automation system may turn on, or flash, lights, or actuate a vibrator to ensure that the authorized attendant will take emergency corrective actions.

Stationary unit

130 may also amplify acoustical information enunciated by the subject. The acoustical information which is received bymicrophone197 is amplified and emitted byspeaker202, or transmitted by

transceiver

205 or206.

FIG. 18 illustrates a block diagram ofportable unit140.Portable unit140 comprises RF transceiver222,speaker225, andbattery227, e.g. a rechargeable battery, for poweringportable unit140.Battery227 may be recharged by dockingport239, which may the same docking port used for the stationary unit or a separate charger. Transceiver222 receives wireless signal S₂when transmitted by the stationary unit. Wireless signal S₂is then enunciated by means ofspeaker225. Alternatively,portable unit140 may comprise a cellular transceiver (not shown) for receiving a wireless signal via a cellular network.

Portable unit

140 may also comprisemicrophone231 and Push-to-Talk (PTT)button232. When the authorized attendant who is accessible toportable unit140 desires to vocalize voice information, e.g. soothing words of comfort to an infant,PTT button232 is depressed, andmicrophone231 transmits the voice information to transceiver222, which transmits the same as signal V to transceiver206 (FIG. 17) of the stationary unit. The voice information is therefore able to be enunciated by speaker202 (FIG. 17) of the stationary unit and heard by the infant.

In one embodiment,portable unit140 also comprisesmicrocontroller237 anddisplay234, e.g. an LCD. A wireless status signal S₂indicative of a subject related parameter of interest can be transmitted from the stationary unit to transceiver222, which is subordinate tomicrocontroller232. A relevant subject status can be displayed onalphanumeric display234, or by means of optical indicators, e.g. LEDs.

FIG. 19 illustrates another embodiment of a subject monitoring system, which is designated by numeral240. In the example ofFIG. 19,detector unit20 is configured to emit a sound or audio signal (for example, of known or predetermined sound contact)—for example,detector unit20 includes a speaker. The audio signal (i.e. ‘alert signal’ contingent upon a detected presence of a symptom of apnea or another detected condition of the subject) is then detected by a sound-detection unit (which may be stationary or portable—inFIG. 19 it is illustrated as ‘stationary unit’) that is deployed within audible range of the detector unit20 (e.g. at least 2 meters or 5 meters or 10 meters and/or at most 100 meters or 20 meters or 10 meters).Sound detection unit130 includes a microphone configured to detect sound and to generate an electrical signal descriptive of the detected sound. In addition, the system240 may include electrical circuitry (i.e. including any combination of digital or analog electrical hardware and/or software/executable computer code—for example, including one or more microprocessors, volatile and/or non-volatile memory, and/or executable code stored in memory) configured to analyze the electrical signal descriptive of the detected sound and to determine if the electrical signal descriptive of the detected sound matches the pre-determined and/or known audio alert signal. This allows for distinction between ambient noise and other noise and noise specifically emitted bydetection unit20. This electrical circuitry may be deployed in any location—for example, as part ofunit130 or in any other location.

System240 may also include an alert signal-emitting unit (e.g. including a speaker or visual display or digital computer configured to sent an electronic communication) configured, in response to the results of the analysis by the electrical circuitry, and contingent upon a positive matching (i.e. a determination that the electrical signal descriptive of the detected sound from the microphone does match the sound characteristics of the audio alert signal), to emit one or more additional alert signals.

In some embodiments, the alert signal emitting unit and the sound detection unit are provided a asingle unit130 and co-reside in the same housing. It is appreciated that this is not a limitation, and other implementations are possible.

System240 may also include an additionalportable unit150 and/oroverride unit250 in communication with alert signal-emittingunit130

As shown inFIG. 20,override unit250 comprisesRF transceiver242 andvideo frame generator247.Override unit250 is connected to set-top box251, the function of which is well known to those skilled in the art and which is also connected tohome entertainment system255. When signal S₂is received bytransceiver242, the display of a program via set-top box251 andhome entertainment system255 is temporarily interrupted, whereupon a predetermined video frame is displayed onhome entertainment system255. When signal S₂is a warning signal or is based on voice information vocalized by the infant, the voice information can be heard onhome entertainment system255. If so desired,override unit250 may be used to actuate a home automation system, for activating a device to alert an authorized attendant.

While some embodiments of the invention have been described by way of illustration, it will be apparent that the invention can be carried out with many modifications, variations and adaptations, and with the use of numerous equivalents or alternative solutions that are within the scope of persons skilled in the art, without departing from the spirit of the invention or exceeding the scope of the claims.