ITBS20080208A1 - ACTIVE SYSTEM FOR THE MONITORING AND PREVENTION OF APNEA PHENOMENON OF SLEEP AND THE SYNDROME OF THE SUDDEN DEATH DEATH - Google Patents

Description

DESCRIPTION of the invention having as TITLE:

"Active system for monitoring and preventing sleep apnea and sudden infant death syndrome"

DESCRIPTION

The present invention is intended to describe a monitoring system that can be used in monitoring infants, children and adults showing signs of sleep disturbances such as Sudden Infant Death Syndrome, apnea and / or narcolepsy. The device intends, in particular, to address the monitoring of newborns at risk of Sudden Infant Death Syndrome, a phenomenon also known as sudden infant death syndrome or unexpected infant death or, in common terminology, "cot death" (in Sudden Infant Death Syndrome or SIDS). This is a phenomenon that still has no explanation in the scientific community and manifests itself by causing the sudden and unexpected death of an apparently healthy infant; death always remains unexplained even after post-mortem examinations have been performed. The syndrome affects children in the first year of life and is still the leading cause of death of healthy children. It has an estimated incidence, for similarity with other states, which varies between 0.7 and 1 per thousand, but there are currently no precise statistical data in Italy.

Faced with the impossibility of determining an univocal cause, epidemiological studies have been carried out which have revealed the existence of some preventable risk factors and others that cannot be prevented, but none of these is however considered a specific cause of SIDS. There are currently no proven methods of prevention, although studies show that, among the main causes, there is the sleeping position other than supine (the risk is also considered 12 times higher if the newborn sleeps on the stomach). Greater frequency was then found in relation to the sex and age of the newborn, to ethnic origin, to the cultural and economic level of the parents.

In reality, SIDS monitoring systems are known: for example, there is patent n ° US2002 / 0057202 A1 which describes a system that works by monitoring the baby's breathing and body temperature, alerting the mother or another external person in case of need. US 2002/0097155 A1 also discloses a similar system, which acts by transmitting the ambient noise to a remote station. Similarly, the patents W02008079296, US20081 50730, W02008076464, JP2008048819, US2008015457, US2007292971, US2007261 173, US2007244404, US20071 57384, US2006097879, GB2396043 describe various solutions to place remote sensors and / or to transmit vital signals. the parent or caregiver of the child. However, none of these systems provide for immediate action on the child, even in the absence of the parent. The purpose of the invention is to describe a system which, together with the monitoring and acoustic alarm system, combines an active system on the child, so as to compensate for the intervention delay linked to the multiple factors that make the acoustic alarm alone unsafe. Moreover, none of these systems keeps track of the recorded parameters, effectively preventing us from understanding what happened before the emergency.

Think, for example, of a case in which the parent has gone away even going to the garden or on the balcony, has fallen asleep, either in the bathroom, on the phone, is busy in the kitchen, has hearing difficulties, ... in all these cases the acoustic warning signal alone could imply an intervention by the parent after a few minutes of apnea, with consequent serious brain damage for the child; also think of the case of adults with sleep apnea disorders, who could also be alone in the house and in whose case, therefore, the acoustic alarm would not alert any decisive intervention. In order to solve this problem, which is still unsolved, the present invention provides for equipping the monitoring station placed in contact with the patient with a series of devices capable of attempting to awaken the monitored subject and bring him back to a less profound sleep state. By way of example and not exhaustively, the use of a strong air current, the emission of intense noises and / or odors, small mechanical vibrations are indicated as systems to wake up the sleeping subject. The general scheme of operation is represented in figure 1.

Numerous epidemiological studies underline that there are a series of non-preventable risk factors such as being male, being less than 6 months old, being born prematurely, winter; but just as many risk factors are preventable.

Among the preventable conditions are:

* Cigarette smoking in the house

<*> Mother who smokes or is on nicotine patches during pregnancy * Insufficient nutrition and prenatal care

<*> Use of heroin and alcohol

<*> Obesity

<*> Lack of breastfeeding

<*> Room temperature too high

Excessive clothing

Excessive use of blankets

Respiratory infections

* Sleeping position other than supine

<*> Long QT

The hypothesized device, therefore, will be composed, together with other satellite units, of a unit aimed both at monitoring some of the preventable risk phenomena and at monitoring fundamental vital parameters. It will therefore be equipped with:

- sensors to measure the baby's oximetry

- a heart rate monitoring system

- a system for monitoring the respiration rate

- a pneumatic mat to monitor the movements of the child by measuring the variations in the air pressure inside the mat

- environmental thermometer

- patient's body temperature sensor

- environmental cigarette smoke detector

The pneumatic mat can be replaced by any other device capable of recording local variations in pressures (e.g. resistive or capacitive mats), however, in the light of what will be said later on the generation of slight mechanical vibrations to awaken the patient, the pneumatic solution seems to be the best performing solution.

These devices therefore detect an environmental signal to transfer it, via wire or electromagnetic waves (by way of example, imagine the smoke detector as an external entity connected wirelessly to the base unit) to a processing unit.

The processing unit can be located either on the bedside or remotely. In this case, on the bedside there will be a card with the task of collecting the signals and then transferring them, via wireless or wire, to the central processing unit. The processing center will be equipped with a resident software designed to establish on time whether the parameters detected by the bedside structure are compatible with a normal situation or correspond to known medical emergency situations. The software must also take into account pre-existing pathological situations, which is why the software could either self-learn what the patient's normal situation is, including a pathological situation, or be informed from the beginning of the pre-existing pathological situation (for example a natural slow heart rate). In this case, the software will compare the data detected by purifying them of the alterations due to the existing pathological situation in order to avoid a series of false alarms. If any discrepancies are recognized as a risk situation, it will be the task of the central unit to activate the most appropriate intervention procedure: in some cases it will limit itself to informing the parent or the staff in charge of the child's care, in other cases, or past for a certain period of time, the intervention and / or resuscitation systems will be activated autonomously. In order to guarantee the safety of use, the decision-making systems could be redundant and installed both on the bedside unit and in the central unit.

The system will be completed by one or two further stations: a remote station, possibly coinciding with the processing unit, capable of emitting light and sound signals in the event of an alarm, and a possible portable station capable of repeating, according to an appropriate input received from the central station, light and sound signals. This last station, portable, must be able to receive the alarm signal within a radius of at least one hundred meters, in order to allow the person in charge of surveillance to leave to carry out further tasks.

As regards the basic structure on the edge of the bed, this must contain both the sensor power supply system and the data reception system from the various sensors. This facility will also manage active intervention in the event of an emergency. Two different types of approach are envisaged for active intervention: a real resuscitation intervention, intended for use in high-risk patients, and a prevention level to be used in most cases.

The resuscitation intervention foresees the presence on the bedside of a real defribillation system, with the relative sensors and signal processing unit together with a forced air circulation system with the task of facilitating the resumption of breathing. This very expensive system can be adopted in particular cases and in the monitoring of children with previous A.L.T.E. (Apparent Life-Threatening Event), while in the remaining cases it will be limited to bringing the patient to a less deep sleep state. In order to awaken the child, a series of devices are provided to stimulate the response and return to the waking state, and to favor the exchange of air near the child and the consequent resumption of natural breathing. Some studies, in fact, correlate the phenomena of ALTE and SIDS to phenomena of stagnation of carbon dioxide or by external input, for example smoke, or by the emission of the child itself, for example by breathing on the stomach on a pillow. The bedside station, in the case of a preventive intervention, therefore provides a system for inducing forced circulation of air such as a fan or a system for generating and distributing compressed air, a system for inducing vibrations of the mattress, for example blowing and deflating compressed air into the pneumatic mat used to measure the pressure, or using a mechanical system, for example an eccentric, a loudspeaker for the emission of sounds and a powerful light possibly capable of emitting different colors and at variable intensity. The generation of air and / or noise can also be obtained from a disposable pyrotechnic charge, which can be substituted for use. The system can also be equipped with a system for the emission of odors and / or vapors aimed at stimulating the child's response.

The bedside structure or, indifferently, the remote structure, will be equipped with a data storage unit on permanent support (indifferently solid state, flash, magnetic or optical support, ...), with a buffer proportional to the identified risk. for the child. At the end of the available space, the system will start rewriting the data starting from the oldest data.

The central structure or, indifferently, the bedside structure, will also be equipped with a communication port towards the internet in order to allow the transmission of data even at a distance.

The system can be equipped with an infrared camera in the bedside structure and a screen in the central structure to allow the child's conditions to be viewed from a distance.

The portable structure can be powered by batteries, all the remaining devices can be powered both from the mains and from the battery, even if it is clear that, for safety reasons, a mains power supply with the presence of a battery would be appropriate for cases of electric blackout. .

For a better understanding of what has been described above, it is possible to refer to the “Drawings” section. In particular:

FIGURE 1: the general architecture of the system and the logical steps related to this patent are illustrated, without the intention of limiting it in any way; the flow chart highlights the steps necessary for the operation of the device. However, not all the steps highlighted in FIG.1 must be implemented, indeed, some could be skipped or even modified or replaced with others, to achieve the same result.

Claims (1)

CLAIMS of the Invention having as TITLE: "Active system for the monitoring and prevention of sleep apnea and sudden infant death syndrome" On the basis of what has been described, the use of an automatic intervention system active on the patient combined with a monitoring system of vital and environmental parameters is claimed which in case of detection of an increased risk of apnea or respiratory syndromes such as ALTE and / o SIDS can alert the caregiver and, in the absence of this or pending this, can reduce this risk by speeding up the patient or reducing environmental risk factors; if a serious anomaly of certain vital parameters is found, the system will start resuscitation of the patient. Claim 1 The use of an electronic and mechanical system is claimed which, together with an environmental monitoring system and a monitoring system of fundamental vital parameters, combines an active automatic system capable, in case of deviation of the parameters from the expected values, to awaken / resuscitating the patient is able to make up for the delay in intervention linked to the presence of the acoustic alarm only, as it happens in current systems. Claim 2 The use of preferentially two units is claimed, in order to implement the system described in the previous point: a basic unit, preferably dedicated to data processing and communication to the outside, which can also be placed in a place far from the patient, and a active unit positioned on the monitored person, dedicated to the detection of parameters and active intervention. The system described in the present invention can, however, also use further portable satellite units, in order to retransmit the alarm signal to a remote device that can be easily worn by the parent or by the personnel assigned to supervise the child / patient. Claim 3 In order to implement the system described in claim 1, the novelty is that of equipping the monitoring station placed in contact with the person with a series of devices capable of attempting to awaken the monitored subject and / or to bring him back to a state of less sleep. deep and / or to stimulate a reaction by reactivating breathing. By way of example and not exhaustively, the use of a strong air current, the emission of intense noises and / or odors, small mechanical vibrations are indicated as systems to wake up the sleeping subject. Claim 4 It is claimed that, for the purposes of activating said awakening devices, the system will be equipped, presumably in the remote unit, in order to contain the dimensions of the bedside unit, with processing capacity and resident software able to establish on time whether the parameters detected by the bedside structure are compatible with a normal situation or correspond to known medical emergency situations. It will be the task of the processing unit to activate the most appropriate intervention procedure. It is specified that the intervention procedures may be different according to the deviations of the measured parameters. In some cases it will be limited to informing the parent or the staff in charge of the child's care, in other cases, or after a certain period of time, the intervention and / or resuscitation systems will be activated autonomously. In order to guarantee the safety of use, the decision-making systems described could be redundant and installed both on the bedside unit and in the central unit. Claim 5 In order to implement the system described in claim 1, it is claimed that the monitoring station is equipped with sensors suitable both for monitoring some of the preventable risk phenomena and for monitoring fundamental vital parameters. It will therefore be equipped, by way of example and not exhaustively, simultaneously or alternatively, with: - sensors to measure the baby's oximetry - a heart rate monitoring and / or counting system - a system for monitoring the respiration rate - a system for measuring the patient's movements - environmental thermometer - patient's body temperature sensor - environmental detector of cigarette smoke and / or other polluting gases It should be noted that the previous detection systems can be indifferently electrical, electronic, mechanical or optical and that the individual subsystems can communicate with each other both via cables and electromagnetic waves, according to proprietary, free or commercial communication protocols. Claim 6 It is claimed that the basic structure on the edge of the bed will contain both the sensor power supply system and the data reception system from the various sensors. This facility will also manage active intervention in the event of an emergency. Claim 7 A structure capable of intervening with active intervention is claimed, where two different types of approach are envisaged for the active intervention: a real resuscitation intervention, intended for use in high-risk patients, and one at the level of prevention to be used in most cases. The resuscitation intervention foresees the presence on the bedside of a real defibrillation system, with the relative sensors and signal processing unit together with a forced air circulation system with the task of facilitating the resumption of breathing. This very expensive system can be adopted in particular cases and in the monitoring of children with previous A.L.T.E. (Apparent Life-Threatening Event), while in the remaining cases the patient will be limited to bringing the patient to a less deep sleep state and / or inducing an autonomous resumption of breathing by inducing a change of air. Claim 8 The use of a series of devices is claimed to both stimulate a response from the patient and return to a state of wakefulness or less deep sleep and to favor the exchange of air near the child and the consequent resumption of natural breathing. . The bedside station, in the case of a preventive intervention, therefore provides a system for inducing forced circulation of air such as a fan or a system for generating and distributing compressed air, a system for inducing vibrations of the mattress, for example by blowing and deflating compressed air in a pneumatic mat or using a mechanical system, for example an eccentric, a loudspeaker for the emission of sounds, a powerful light possibly capable of emitting different colors and at variable intensity. The generation of air, also to inflate the mattress, and / or the generation of noise can also be obtained from a disposable pyrotechnic charge, replaceable for use. Claim 9 The possibility of equipping the system with a system for the emission of odors and / or vapors aimed at stimulating the child's response is claimed. Claim 10 The claim is made to equip the bed edge structure or, indifferently, the remote structure, with a data storage unit on permanent support (indifferently solid state, flash, magnetic or optical support, ...), with a buffer proportional to the risk identified for the child. At the end of the available space, the system will start rewriting the data starting from the oldest data. Similarly, the central structure or, indifferently, the bedside structure, will also be equipped with a communication port towards the Internet, in order to allow the transmission of data even at a distance. Claim 11 The portable structure can be powered by batteries, all the remaining devices can be powered both from the mains and from the battery, even if it is clear that, for safety reasons, a mains power supply with the presence of a battery would be appropriate for cases in which mains power supply interruptions may occur.