WO2016139598A1

WO2016139598A1 - Device for detecting neonatal apneas and bradycardia

Info

Publication number: WO2016139598A1
Application number: PCT/IB2016/051177
Authority: WO
Inventors: Luca Dario Marco ROSTI; Ezio AIME'
Original assignee: Rosti Luca Dario Marco
Priority date: 2015-03-04
Filing date: 2016-03-02
Publication date: 2016-09-09

Abstract

The present invention relates to a device for detecting apneas and bradycardia to be used in particular on infants. In particular, the present invention relates to a device (1) for detecting apneas and/or bradycardia, typically in a newborn or infant, comprising a bodysuit (2) provided with first and second sensors (3, 3') and a first control unit (10) adapted to send a detected signal to a second control unit (4) separate from said bodysuit (2) and in turn adapted to send data and signals, such as an alarm signal, in wireless mode to a remote electronic device.

Description

"DEVICE FOR DE TECTING NEONATAL APNEAS AND

BRADYCARDIA"

Description

The present invention relates to a device for detecting apneas and bradycardia to be used particularly on newborns and infants.

Prior art

Sudden infant death syndrome (SIDS) refers to the death of an infant for which it is impossible to identify an explanation, despite an exhaustive search. SIDS falls within the group of SUIDs (Sudden Unexpected Infant Death) , which have a variety of causes such as suffocation, inhalation, infections, metabolic disorders and (accidental and non- accidental) trauma.

In recent decades, several hypotheses about the causes of SIDS have been suggested and confirmed or discarded, and SIDS often remains a diagnosis of exclusion, after evaluating and discarding all other possible known causes. Several risk factors for the development of an SIDS are also known.

According to statistics of the early '90s, the frequency of SIDS in the United States had been calculated around 120 deaths per 100,000 live births. In relation to the numerous etiopathogenetic hypotheses, some practical actions have been shown to reduce the incidence of SIDS, which in 2011 dropped to a value of 53 cases for every 100,000 births.

Despite this significant reduction, SIDS remains the third leading cause of death in infants and the first one at postnatal age (28 days-12 months) .

The preventive actions suggested and proved effective in preventing SIDS are:

- making the infant sleep in a cot or cradle of modern conception,

letting the infant sleep in the room with his/her parents, but not in their bed,

- keeping the room cool (max 20 °C) and humid, avoiding covering the baby too much, especially at the head height,

- using firm, anti-suffocation mattresses,

- avoiding mattresses, duvets, bumpers, padded cushions where the child can sink his/her face,

- not smoking in the house,

- using the pacifier after the first month of life and breastfeeding well underway,

making the infant sleep in the supine position .

The latter expedient is the most important one and is probably the main cause of halving of the incidence of SIDS at the early 2000' s.

Nevertheless, cases of SIDS still occur. This makes the parents often live in fear that this event may happen to their child, and even in the absence of certain risk factors, they live the first months of the child's life with great anxiety.

In the wake of the fears for SIDS, in recent decades various devices have been marketed to try to monitor the baby during his/her sleep. Examples of such devices are as follows:

a) sets of transmitters which pick up the noise coming from the baby's room and broadcast it to a receiver in the parents' room,

b) mats with motion sensors, which trigger an alarm when the baby does not move for a certain number of seconds.

For the first case, there is the problem that such devices are not provided with alarm systems and they simply detect the ambient noise, without making a real monitoring of the baby's physiological parameters .

On the other hand, false positives are possible in the second case due to an excess of sensitivity or to the lack of ability to pick up the actual movements of the newborn, or vice versa false negatives may occur.

In recent years, progress in electronics/computer technology has enabled the development of the so-called "smart textiles", which contain a series of vital parameters directly in the fiber woof, which can act as sensors. These fibers convey the signal to a chip, which in turn transmits it remotely, via blue-tooth, Wi-Fi or direct connection to a computer.

The prior-art document U.S. 2005/0034485 describes a garment provided with sensors to control the heartbeat and breathing in a baby, able to send the data gathered to a control unit in wireless mode; in particular, the ECG sensors are placed on the chest at the level of the collar bones and of the heart .

Patent application U.S. 2014/0318699 describes a garment which incorporates sensors for detecting the heartbeat and breathing, wherein said sensors are located on the chest.

Document U.S. 2014/0343389 describes a system for real-time and wireless control of physiological signals such as temperature, blood pressure, oxygen level, electrical conduction, breathing and heartbeat through suitable sensors (3A and 3B) ; however, it does not provide any indication as to the ideal placement of such sensors.

Patent application U.S. 2010/0217158 describes baby garments comprising a device on the chest or on the back, provided with sensors able to transmit signals related to physiological functions in wireless mode to an external control unit; such a device is unique and therefore, all the sensors embedded therein have the same position.

A onesie for babies made of a fabric of conductive fibers provided with a sensor able to monitor only the breathing activity and transmit the signals collected in wireless mode to an external unit is described in document WO 2014/138204.

The international patent application WO 2014/043166 describes a belt or a band or a garment comprising such a belt or band for a baby comprising sensors for detecting the heart rate and breathing; while acknowledging that such sensors need to be properly positioned, no indication about their position is provided.

European patent application EP 1.661.512 describes a system for the wireless control of the heartbeat alone, such as not to cause unpleasant sensations to the user due to the contact of the skin with the cold and hard metal material of the sensors; therefore, such a system comprises at least three sensors which are embedded in the fabric of the garment and two of which are placed on the chest at the fourth last rib on the right and left, while the third sensor is generally indicated on the back.

A problem addressed by the present invention is therefore to provide a device for detecting infant apneas and bradycardia which is reliable, safe and comfortable, so as to not disturb the baby during his/her sleep.

Summary of the invention

This and other problems are solved by a device as outlined in the appended claims, whose definitions are an integral part of the present description.

An object of the invention therefore is a device for detecting apneas and/or bradycardia comprising a bodysuit provided with sensors for detecting the heart rate and/or the breathing rate.

A second object of the invention is a device for detecting apneas and/or bradycardia, preferably both, provided with a data transmission system to a remote receiver .

In a preferred aspect of the invention, the device allows detecting both apneas and bradycardia. Further features and advantages of the present invention will become more apparent from the description of some exemplary embodiments, given hereinafter as a non-limiting indication, with reference to the following figures:

Figure 1 shows a schematic front view of the device for detecting apneas and bradycardia according to an embodiment of the invention;

Figure 2 shows the device described by the prior-art document U.S. 2005/0034485;

Figure 3 shows the device described in U.S. 2014/0318699 provided with sensors (3A and 3B) ;

Figure 4 shows a garment for a baby (reference 38 in figure 4A) and for an adult (reference 40 in figure 4B) provided with a sensor (reference 34) described in U.S. 2010/0217158.

Detailed description of the invention

With reference to the figure, the device for detecting apneas and bradycardia according to the invention, shown as a whole with reference 1, comprises a bodysuit 2 provided with first and second sensors 3, 3' and with a first control unit 10 and a second control unit 4 separate from said bodysuit 2.

In the embodiment of the figure, the bodysuit 2 is a so-called "onesie" for infants and comprises a front trunk portion 2a and a back trunk portion 2b joined along their perimeter 5, such as through a seam, forming the bodysuit. Bodysuit 2 comprises an upper opening 6 for the head, two upper side openings 7, 7' for the arms and two lower side openings 8, 8' for the baby's legs. The lower joining side 9 between the two trunk portions 2a, 2b can be opened/closed, such as by a snap fastener or Velcro®, so as to allow the baby to wear the bodysuit.

In some embodiments, the bodysuit will have the form of a half-sleeve T-shirt, a long-sleeve T-shirt or a vest, i.e. it will be open at the bottom.

The bodysuit is made of a soft, non-allergenic, elastic fabric comfortable for the baby. Preferably, a stretch fabric will be used.

Typically, the fabrics normally used to manufacture garments for infants will be used, such as cotton or synthetic fibers.

In some embodiments, the fabric consists of a so-called "smart textile" or "e-textile". This type of fabrics is known and can be obtained starting from a yarn which contains conductive fibers or by including conductive fibers localized in delimited portions of a fabric.

The conductive fibers may be inorganic (metals such as gold, copper, etc.) or organic in nature. The latter are recommended for their low cost and greater flexibility of use. Known examples of such conductive organic materials are polyacetylenes , polypyrroles , polyanilines and copolymers thereof. Other polymers that can be used for this purpose are poly(p- phenylene vinylene) and derivatives thereof and poly ( 3-alkylthiophenes ) .

The "e-textiles" used for the purposes of the present invention will comprise conductive fibers as defined above in their weft or in the warp to establish an electrical connection between different points of the bodysuit, as shown by the solid 11 and dashed lines 11 ' in the figure which connect the first and the second sensors 3, 3 ' to the first control unit 10.

The first sensors 3 are typically two, positioned laterally to the chest, approximately at the level of the portion corresponding to the bottom of the ribs or slightly below, and are adapted to detect the breathing rate. For example, sensors which detect impedance variations correlated to the expansion of the chest will be used, such as a sensor of piezoelectric material.

The second sensors 3' are typically three, placed on the chest, slightly above the point corresponding to the baby's nipples, the third one on the back, in a position laterally adjacent to the spine and slightly below the point corresponding to the shoulder blades, that is, at the lower end of the shoulder blades. Such sensors 3' are adapted to detect the heart rate (ECG signal) and are typically electrodes for picking up the ECG signal.

Therefore, according to the present invention, the sensors that control breathing and those that control the heartbeat have different positions.

The first and the second sensors 3, 3' are known by the man skilled in the art and will not be described in further detail.

The first sensors 3 are connected to each other and the latter to the first control unit 10 by means of a suitable wiring 11, such as through the conductive fibers of an "e-textile" as described above. The second sensors 3' are instead directly connected, through a wiring 11, 11', to the first control unit 10.

In one aspect of the invention, the device described does not comprise positioning sensors in order to detect whether the baby has moved in his/her sleep and in which position he/she is sleeping. The first control unit 10 is powered by a micro- battery 12 and may comprise an on/off switch. It further comprises a system for the wireless reception, transduction and transmission of the signal from sensors 3, 3'.

The first control unit 10 preferably has a miniature size. In a preferred aspect of the invention, this is contained in a flexible, deformable and sealed enclosure so as to prevent the accidental opening thereof and withstand repeated washing in a washing machine. The first control unit 10 will be placed at a point of minimum encumbrance and discomfort for the baby, such as in the proximity of a seam, at the shoulder level, at the front, in the area between the deltoid muscle and the pectoralis major.

The micro-battery 12 is disposable or rechargeable and preferably has a duration of at least 3 months, preferably at least 6 months, more preferably at least one year.

The first control unit 10 sends the detected signal to the second control unit 4, which is separated from bodysuit 2 but will generally be placed in the proximity thereof. Such a signal transmission takes places in wireless mode, such as via Wi-Fi or Bluetooth.

The second control unit 4 in turn comprises a signal and data reception and transmission system, an on/off switch and a microcontroller for processing the signal so as to provide the following output data :

- instant heart rate, and/or

- heart rate trend over a given period, and/or

- instant breathing rate, and/or

breathing rate trend over a given period, and/or

- alarm signal if the heart rate is outside of a preset frequency range, and/or

alarm signal in case of breathing pauses higher than a preset time value.

In some embodiments, the second control unit 4 comprises a screen 13 for displaying the output data listed above and optionally a sound signal emitter to spread the alarm.

In some embodiments, the second control unit 4 is powered by the grid using a suitable electrical connection cable 14. In other embodiments, it is powered by a dedicated rechargeable or disposable battery .

In some embodiments, the second control unit 4 may also comprise a USB socket 15 for the connection to an electronic device, such as a computer, for processing the recorded data.

The second control unit 4 further comprises an on/off button 16.

The second control unit 4 further comprises a fixed or removable memory card to store the data received and processed. Preferably, such a memory card can store data for a period of at least 7 days.

The data and signal reception and transmission system of the second control unit 4 is adapted to transmit data and signals, such as an alarm, in wireless mode, for example via Wi-Fi or Bluetooth, to a remote electronic device such as a computer, a tablet or a smartphone, which will be provided with suitable software/app. Preferably, said reception and transmission system will be adapted to transmit at a distance of at least 20 meters.

The alarm signal will preferably be a sound signal, but in certain embodiments it might also be a vibration signal.

The device of the invention works as follows.

Bodysuit 2 is worn by the baby, so as to make sensors 3, 3' adhere at the level of the preset positions. To this end, bodysuit 2 will be manufactured in various sizes depending on the body size of the baby.

The first and the second control unit 10, 4 are then switched on and the second control unit 4 is placed in the proximity of the bed or cradle in which the baby lies.

If apnea happens to the baby, sensors 3, 3' will send a corresponding signal to the first control unit 10, which in turn will send a signal to the second control unit 4. After processing the signal, the latter will send an alarm signal to the electronic device placed in the proximity of an adult, who will be able to promptly intervene.

The advantages of the device of the invention are apparent from the description above.

In fact, the detection device of the invention is safe and reliable and allows promptly notifying a parent of the baby's breathing and/or heart conditions, thereby allowing the intervention thereof .

In a preferred aspect of the invention, the device allows controlling both the heart activity and the breathing activity of the baby.

The device has a simple design and is constructively cost-effective. Moreover, the incorporation of the device in a bodysuit allows the correct positioning and maintenance of the sensors in the optimal positions.

It is apparent that only some particular embodiments of the present invention have been described, and those skilled in the art will be able to make all the necessary modifications for its adaptation to particular applications, without thereby departing from the protection scope of the present invention.

Claims

1. A device (1) for detecting apneas and bradycardia, typically in a baby, comprising a bodysuit (2) provided with first and second sensors

(3, 3') and with a first control unit (10) adapted to send a detected signal to a second control unit

(4) separate from said bodysuit (2) and in turn adapted to send data and signals, such as an alarm signal, wirelessly to a remote electronic device.

2. A device (1) according to claim 1, wherein the bodysuit (2) is a so-called "onesie" for babies and comprises a front trunk portion (2a) and a back trunk portion (2b) joined along their perimeter (5), such as through a seam, the bodysuit (2) comprising an upper opening (6) for the head, two upper side openings (7, 7') for the arms and two lower side openings (8 , 8') for the legs of the baby, wherein the lower joining side (9) between the two trunk portions (2a, 2b) can be opened/closed, such as by a snap fastener or Velcro^®, so as to allow the baby to wear the bodysuit.

3. A device (1) according to claim 1 or 2, wherein the bodysuit (2) is made of a soft, non- allergenic, elastic fabric comfortable for the baby, preferably of a stretch fabric.

4. A device (1) according to any one of claims 1 to 3, wherein the fabric is made of a so-called "smart-textile" and comprises inorganic or organic conductive fibers for establishing an electrical connection by wiring (11, 11') between the first and second sensors (3, 3') and the first control unit (10) .

5. A device (1) according to any one of claims 1 to 4, wherein the first sensors (3) are two, positioned laterally to the chest, approximately at the level of the portion corresponding to the lower part of the ribs or slightly below, and are adapted to detect the breathing rate, such as by detecting impedance variations correlated to the expansion of the chest.

6. A device (1) according to any one of claims 1 to 5, wherein the second sensors (3') are three, two positioned on the chest, slightly above the point corresponding to the baby's nipples, the third on the back, in a position laterally adjacent the spine and slightly below the point corresponding to the shoulder blades, said sensors (3') being adapted to detect the heart rate (ECG signal) .

7. A device (1) according to any one of claims 1 to 6, wherein the first sensors (3) are connected to each other and the latter to the first control unit (10) by means of a suitable wiring (11), while the second sensors (3') are directly connected, by means of a wiring (11, 11'), to the first control unit (10) .

8. A device (1) according to any one of claims 1 to 7, wherein the first control unit (10) is powered by a micro-battery (12) and may comprise an on/off switch, said control unit (10) further comprising a system for the wireless reception, transduction and transmission of the signal from the sensors (3, 3') .

9. A device (1) according to any one of claims 1 to 8, wherein the first control unit (10) is contained in a flexible, deformable and sealed enclosure .

10. A device (1) according to any one of claims 1 to 9, wherein the second control unit (4) comprises a signal and data reception and transmission system and a signal processing microcontroller so as to provide the following output data:

- instant heart rate, and/or

- heart rate trend over a given period, and/or

- instant breathing rate, and/or

breathing rate trend over a given period, and/or - alarm signal if the heart rate is outside of a preset frequency range, and/or

alarm signal in case of breathing pauses higher than a preset time value.

11. A device (1) according to any one of claims 1 to 10, wherein the second control unit (4) comprises a screen (13) for displaying the output data, a fixed or removable memory card and optionally :

- a sound signal emitter to spread the alarm, and/or

- an on/off switch, and/or

a USB socket (15) for connection to an electronic device, such as a computer, for processing the recorded data.

12. A device (1) according to claim 10 or 11, wherein the data and signal reception and transmission system is adapted to transmit at a distance of at least 20 meters.