Method And Device For Monitoring The Risks For Sudden Infant Death Syndrom And For Positional Plagiocephaly

• US 20120083670A1
• Filed: 09/07/2011
• Published: 04/05/2012
• Est. Priority Date: 09/07/2010
• Status: Active Grant

• Current Assignee: Mondevices, Inc.
• Original Assignee: Alta Lab S.R.L.
• Inventors: Rotondo, Giuseppe, Frosio, Iuri
• Granted Patent: US 8,864,665 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2503/04 Babies, e.g. for SIDS detection
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G08B 21/0211 Combination with medical sensor, e.g. for measuring heart rate, temperature
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A portable monitoring device for monitoring of the short term, mid term and long term risks of Sudden Infant Death Syndrome (SIDS) and to estimate the risk of onset of positional plagiocephaly. The monitoring device acquires one or more signals associated to the typical breath and positioning patterns of an infant through a tri-axial accelerometer, and registers the data in electronic format, where statistical analysis of the signal and pattern recognition are performed in real time by a processing unit. The device monitors the breath activity of an infant in various conditions, alerting a caregiver when a potentially dangerous situation is detected. The monitoring is attached to the clothes of the infant. Statistical analysis of the registered data is performed for quantifying the long term SIDS risk, the risk of plagiocephaly and for optimizing the functional parameters of the monitoring device.

Claims

1. A method for performing the monitoring of the risks of Sudden Infant Death Syndrome (SIDS), and positional plagiocephaly, comprising the method steps of:

providing at least one sensor device (102) capable of converting at least one physical magnitude into at least one electrical signal associated to the typical breath and positioning patterns of an infant;

providing a processing unit capable of acquiring from the sensor device the generated electrical signal, converting the electrical signal in numeric signal data and storing the signal data into a local memory;

using the processing unit for processing the stored signal data and for generating different kind of alarms for the caregiver whenever a risk of SIDS or plagiocephaly above a predefined threshold is detected;

wherein

at least one of the sensor devices and the processing unit are disposed within a common housing forming a single wearable monitoring device, which is attached to the infant clothes or to the infant head;

that

an energy storage of the monitoring device is provided with energy allowing continued operation without recharge for an autonomous operation period of at least 12 hours;

that

numerical signal data generated during the operation period are transferred to the local memory during the operation period;

that

the processing unit utilizes statistical analysis and/or pattern recognition algorithms, applied in real time to the signal data, to recognize potentially dangerous situations in the short and mid term during the current operation period; and

that

the data stored in the local memory are downloaded on an external processing unit and a statistical analysis, clustering and/or pattern recognition algorithm is applied to the data of more than one operation period to identify the long term risk of SIDS or plagiocephaly, and/or to optimize the reliability of the monitoring device with respect to the particular environment and/or infant characteristics.

2. The method according to claim 1, wherein the at least one sensor devices measure the infant movements and/or the infant body and/or head orientation by at least one tri-axial accelerometer.

3. The method according to claim 1, wherein the monitoring device is safely and comfortably attached to the infant by a system based on snap fasteners, hook-and-loop fastener bands or other securing means to allow for accompanying the infant in any desired sleeping location.

4. The method according to claim 1, wherein the monitoring device is recharged through a standard USB port, and the same USB port is used for downloading data from the monitoring device to an external processing unit or to communicate with the monitoring device.

5. The method according to claim 1,

wherein:

a. the signal data are digitally processed in real time by the processing unit to extract characteristic signal features;

b. the processing unit performs in real time statistical analysis and/or pattern recognition on the extracted features, to identify different orientations and acceleration patterns, each pattern being associated with different short term or mid risk of SIDS or risk of plagiocephaly;

c. the identifiable patterns are at least associated with the status conditions;

“

infant not breathing”

, “

infant sleeping in prone position”

, “

infant sleeping on left side”

, “

infant sleeping on right side”

, “

infant sleeping in supine position”

, “

infant awake”

;

d. the processing unit generates a high_short_term_SIDS_risk_alarm at least when the “

infant not breathing”

pattern is detected for a predefined amount of time;

e. the processing unit generates the high_mid_term_SIDS_risk_alarm at least when one of the “

infant sleeping in prone position/on left side/on right side”

pattern is detected for a predefined amount of time;

f. the processing unit generates the high_plagiocephaly_risk_alarm at least when one of the “

infant sleeping on left side/on right side”

pattern is detected for a predefined amount of time;

6. The method according to claims 1,

wherein the historical signal data and/or extracted patterns are downloaded on a external processing unit and are processed by an expert system for an identification of a long term SIDS risk and plagiocephaly onset risk, personalized for the infant, and for an adjustment of the parameters of the statistical model and/or reference pattern and/or the risk thresholds either automatically or based on the feedback from the caregiver.

7. The method according to claim 1,

wherein:

a. the processing unit utilizes a buzzer mounted on board of the monitoring device to stimulate the infant breathing or movements through a sound emission, when a high short/mid term SIDS risk or plagiocephaly risk is detected;

b. the processing unit utilizes a buzzer mounted on board of the monitoring device to stimulate the infant movements through a different sound emission, when the infant lies on the side affected by plagiocephaly;

8. A monitoring device for performing the monitoring of the risks of Sudden Infant Death Syndrome (SIDS) and plagiocephaly, comprising:

at least one sensor device capable of converting at least one physical magnitude into at least one electrical signal associated to the typical breath and positioning patterns of an infant;

a processing unit capable of acquiring electrical signal generated by the sensor device, converting the electrical signals in numeric signal data and storing the signal data into a local memory, and processing the stored signal data and generating different kinds of alarm for the caregiver whenever a risk of SIDS or plagiocephaly above a predefined threshold is detected;

wherein

at least one of the sensor devices and the processing unit are disposed in a common housing forming a single monitoring device, which can be attached to the infant clothes or to the infant head, that

the monitoring device is provided with an energy storage allowing continued operation without recharge for an operation period of at least 12 hours;

that

the local memory has a capacity which is sufficient for storing the signal data generated during the operation period;

that

the processing unit is arranged for utilizing statistical analysis and/or pattern recognition algorithms, applied in real time to the signal data, to recognize potentially dangerous situations in the short and mid term during the current operation period; and

that

the monitoring device is provided with a communication port, through which data stored in the local memory can be downloaded to an external communication unit.

9. The monitoring device according to claim 8,

wherein the at least one sensor device comprises a tri-axial accelerometer which measures the infant movements and/or the infant body and/or head orientation.

10. The monitoring device according to claim 8,

wherein the monitoring device is provided with a snap fasteners, hook-and-loop fastener bands or other securing means for safely and comfortably attaching the monitoring device to the infant;

11. The monitoring device according to claim 8,

wherein the monitoring device is rechargeable through a standard USB port, and the same USB port can be used for downloading data from the monitoring device to a external processing unit or to communicate with the monitoring device.

12. The monitoring device according to claim 8,

wherein the housing of the monitoring device is made from a soft material which is also water-resistant, to avoid potential circuit damage in case of vomits or contact with other liquids, and wherein the housing comprises a shape and size that avoid unwanted ingestion.

13. The monitoring device according to claim 8,

wherein:

a. the processing unit digitally processes the signal data in real time to extract characteristic signal features;

b. the processing unit performs in real time statistical analysis and/or pattern recognition on the extracted features, to identify different orientations and acceleration patterns, each pattern being associated with different short term or mid risk of SIDS or risk of plagiocephaly;

c. the identifiable patterns are at least associated with the status conditions;

“

infant not breathing”

, “

infant sleeping in prone position”

, “

infant sleeping on left side”

, “

infant sleeping on right side”

, “

infant sleeping in supine position”

, “

infant awake”

;

d. the processing unit generates a high_short_term_SIDS_risk_alarm at least when the “

infant not breathing”

pattern is detected for a predefined amount of time;

e. the processing unit generates the high_mid_term_SIDS_risk_alarm at least when one of the “

infant sleeping in prone position/on left side/on right side”

pattern is detected for a predefined amount of time;

f. the processing unit generates the high_plagiocephaly_risk_alarm at least when one of the “

infant sleeping on left side/on right side”

pattern is detected for a predefined amount of time;

14. The monitoring device according to claim 8, wherein:

a. the processing unit utilizes the buzzer mounted on board of the monitoring device to stimulate the infant breathing or movements through a sound emission, when a high short/mid term SIDS risk or plagiocephaly risk is detected;

b. the processing unit utilizes the buzzer mounted on board of the monitoring device to stimulate the infant movements through a different sound emission, when the infant lies on the side affected by plagiocephaly;

15. A software program product including tangible a non-transitory computer readable medium, on which is stored a program for processing signal data generated by a monitoring device for monitoring the risks of Sudden Infant Death Syndrome (SIDS) and plagiocephaly,

wherein the software program product contains code that, when executed by a processor and when using the data generated by the monitoring device during more than one operation period of the monitoring device, performs the steps of:

determining a long term SIDS risk and plagiocephaly onset risk personalized for the infant, and of

adjusting the parameters of a statistical model and/or reference pattern and/or a risk thresholds either automatically or based on the feedback from the caregiver.