Wearable Wireless Device Applicable to the Hand or Foot, Wireless System Including the Device and Method for Reducing the Risk of Different Critical Situations of Hypoxia and/or Bradycardia

• US 20160262637A1
• Filed: 12/04/2015
• Published: 09/15/2016
• Est. Priority Date: 03/10/2015
• Status: Active Grant

• Current Assignee: Apn Intelectual Property LLC
• Original Assignee: Diego Alejandro Delia
• Inventors: DELIA, Diego Alejandro
• Granted Patent: US 9,955,877 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2503/04 Babies, e.g. for SIDS detection
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

A wearable, wireless, non-invasive device applicable to the hand or foot, a wireless system, and a method for reducing the risk of different critical situations of hypoxia and/or bradycardia possibly occurring in victims of sudden infant death syndrome (SIDS), Pierre Robin Sequence patients, preterm babies, and adults, and for the prevention of the sleep apnea, is based on use of a sensor and a computing algorithm sufficient to reduce false alarms and save lives. The device is worn on the hand or foot of a user. Part of the device may be placed on the proximal phalange of a finger or a foot, or even in the palm. The electronics of the device may be placed inside gloves or booties of different sizes to accommodate the hands or feet of different wearers. The device measures blood oxygen saturation and heart rate through a sensor that is preferably a pulse oximeter.

Claims

1. A wearable pulse-oximeter-based device applicable to the hand or foot of a user, said device designed to measure blood oxygen saturation and heart rate values and to reduce critical situations of hypoxia and/or bradycardia that may happen in SIDS episodes, the device comprising:

means for delivering electrical stimulus to the user with a timing pattern and an intensity pattern in order to cause a reaction of the user when a) said device stops measuring heart rate values or blood oxygen saturation values, b) heart rate measurement generates values below a first corresponding predefined limit level, or c) blood oxygen saturation measurement generates values below a second predefined limit level, and

at least one circuit using an algorithm designed to receive said blood oxygen saturation and heart rate values and, based on user predefined parameters and a programed flow chart, carry out checking routines to verify the correct placement of the device on the user'"'"'s body, and set adequate delays in stimulus deliverance when measuring low heart rate or blood oxygen saturation values.

2. The wearable pulse-oximeter-based device according to claim 1, further comprising:

a first timer that measures a first lapsed time (t1) from the moment said heart rate measurements fall below a first user-settable limit, said first timer being adjusted at a first predefined time limit (T1),

a second timer that measures a second lapsed time (t2) from the moment said sensor stops measuring any heart rate values at all, said second timer being adjusted at a second predefined time limit (T2),

a third timer that measures a third lapsed time (t3) from the moment said blood oxygen saturation measurements falls below a second user-settable limit, said third timer (t3) being adjusted at a third predefined time limit (T3), and

a fourth timer that measures a fourth lapsed time (t4) from the moment said sensor stops measuring any blood oxygen saturation values at all, said fourth timer being adjusted at a fourth predefined time limit (T4).

3. The wearable pulse-oximeter-based device according to claim 2, wherein:

if the device does not measure any heart rate value at all and if the second timer is OFF, the device turns the second timer ON and checks if the first timer is also ON, and if the first timer is not ON, the device checks if the second lapsed time (t2) of the second timer has reached the second time limit (T2),

if the second lapsed time (t2) of the second timer has not reached the second time limit (T2) yet, the device returns to measuring the heart rate, and if the second lapsed time (t2) of the second timer has reached the second time limit (T2), the device will deliver an electrical stimulus to the user,

if the device does not measure any heart rate value at all and if the second timer is OFF, it turns the second timer ON and checks if the first timer is also ON, and if the first timer is ON, the device adds the first and second lapsed times (t1+t2) of the first and second timer, and

if a resulting value of adding both the first and second lapsed times (t1+t2) is equal or greater than the first time limit (T1) of the first timer, the device will deliver an electrical stimulus to the user, but if the resulting value of adding both first and second lapsed times (t1+t2) is smaller than the first time limit (T1) of the first timer, the device returns to measuring the heart rate again.

4. The wearable pulse-oximeter-based device according to claim 2, wherein:

if the device measures heart rate values, the device checks if the measured heart rate value is below its predetermined limit, and if this is not verified, the device turns both first and second timers OFF, and the device returns to the step of measuring the heart rate again,

if the device measures heart rate values, the device checks if the measured heart rate value is below its predetermined limit, and, if this is confirmed, the first timer is turned ON and the algorithm checks the correct operation of the device by checking if the second timer is turned ON,

if the second timer is OFF, the device checks if the first lapsed time (t1) of the first timer is equal or greater than its first time limit (T1), and, if this is not verified, the device turns back to the step of measuring heart rate, and, if the first lapsed time of the first timer has reached the first time limit (T1), the device will deliver an electrical stimulus to the user;

if the device measures heart rate values, the device checks if the measured heart rate value is below its predetermined limit, and, if this is verified, the first timer is turned ON, the algorithm checks the correct operation of the device by checking if the second timer is turned ON, and the first lapsed time (t1) of the first timer is added to the second lapsed time (t2) of the second timer, and

if a resulting value of adding both first and second lapsed times (t1+t2) is equal or greater than the first time setting T1 of the first timer, the device will deliver an electrical stimulus to the user, but if the resulting value of adding both first and second lapsed times (t1+t2) is smaller than the first time setting T1 of the first timer, the device returns to measuring the heart rate.

5. The wearable pulse-oximeter-based device according to claim 2, wherein:

if the device does not measure any blood oxygen saturation value at all and if the fourth timer is OFF, the device turns the fourth timer ON and checks if the third timer is also ON,

if the third timer is not ON, the device checks if the fourth lapsed time (t4) of the fourth timer has reached the fourth time limit (T4), and, if the fourth lapsed time (t4) of the fourth timer has not reached the fourth time limit (T4) yet, the device returns to the step of measuring the blood oxygen saturation, but if the fourth lapsed time (t4) of the fourth timer has reached the fourth time limit (T4), the device will deliver an electrical stimulus to the user,

if the device does not measure any blood oxygen saturation value at all and if the fourth timer is OFF, the device turns the fourth timer ON and checks if the third timer is also ON, and, if the third timer is ON, the third lapsed time (t3) of the third timer is added to the fourth lapsed time (t4) of the fourth timer, and

if a resulting value of adding both lapsed times (t3+t4) is equal or greater than the third time limit (T3) of the third timer, the device will deliver an electrical stimulus to the user, but if the resulting value of adding both third and fourth lapsed times (t3+t4) is smaller than the third time limit (T3) of the third timer, the device returns to measuring the blood oxygen saturation.

6. The wearable pulse-oximeter-based device according to claim 2, wherein:

if the device measures blood oxygen saturation values, the device checks if the measured blood oxygen saturation value is below its predetermined limit, and, if this is not verified, the device turns both the third and fourth timers OFF and returns to measuring the blood oxygen saturation,

if the device measures blood oxygen saturation values, the device checks if the measured blood oxygen saturation value is below its predetermined limit, and if this is confirmed, the third timer is turned ON and the algorithm checks the correct operation of the device by checking if the fourth timer is turned ON,

if the fourth timer is OFF, the device checks if the third lapsed time (t3) of the third timer is equal or greater than its third time limit T3, and, if this is not verified, the device turns back to the step of measuring blood oxygen saturation, and, if the third lapsed time (t3) of the third timer has reached the third time limit (T3), the device will deliver an electrical stimulus to the user,

if the device measures blood oxygen values, the device checks if the measured blood oxygen saturation value is below its predetermined limit, and if this is verified, the third timer is turned ON and the algorithm checks the correct operation of the device by checking if the fourth timer is turned ON, and the third lapsed time (t3) of the third timer is added to the fourth lapsed (t4) time of the fourth timer, and

if the resulting value of adding both third and fourth lapsed times (t3+t4) is equal or greater than the first time setting T3 of the first timer, the device will deliver an electrical stimulus to the user, but if the resulting value of adding both lapsed times (t3+t4) is smaller than the first time setting T3 of the first timer, the device returns to measuring the blood oxygen saturation.

7. The wearable pulse-oximeter-based device according to claim 3, wherein:

after delivering a first electrical stimulus, the device sends out a first alarm, wait 10 seconds, and check if a heart rate value or a blood oxygen saturation value was measured,

if measurement of a heart rate value or a blood oxygen saturation value is not confirmed, the device delivers an electrical stimulus to the user, activates the second timer, waits another 10 seconds, and checks again for existence of a measured heart rate value or a blood oxygen saturation value, and

if the measurement of a heart rate value or a blood oxygen saturation value is confirmed, the device checks if the heart rate is below its safe limit and if the blood oxygen saturation value is also below its safe limit, and, if any of these situations are confirmed, the device delivers a second electrical stimulation, sends out a second alarm, and returns to measurement of a heart rate value or a blood oxygen saturation value.

8. The wearable pulse-oximeter-based device according to claim 7, wherein:

after the second stimulation, the device delivers further stimulus signals increasing the discharge current in preset current steps until reaching a maximum preset safety limit is reached, and

said safety limit is selected according to an age and a weight of the user.

9. The wearable pulse-oximeter-based device according to claim 8, wherein a total stimulus signal current range is 0.01 mA to 5.0 mA, and a maximum operation time is 3 minutes.

10. The wearable pulse-oximeter-based device according to claim 1, wherein the device further comprises a housing, a power supply, a microprocessor, electronics for generating electric stimulation, electrical stimulus electrodes, electronics for wireless communications, and a display.

11. The wearable pulse-oximeter-based device according to claim 10, wherein said algorithm is stored in the microprocessor, and said microprocessor contains an alarm generation circuit.

12. The wearable pulse-oximeter-based device according to claim 10, wherein said housing is selected from a group formed by a hand glove, a foot bootie, a ring, and a wrist band.

13. The wearable pulse-oximeter-based device according to claim 10, wherein the device is designed to wirelessly transmit alarms to devices selected from a group formed by smartphones, tablets, PCs, and Internet interfaces communicating with cloud services.

14. The wearable pulse-oximeter-based device according to claim 1, further comprising a human body temperature sensor.

15. The wearable pulse-oximeter-based device according claim 12, wherein, if the selected housing is a ring, said electrodes are in contact with a finger of the user, if the selected housing is a hand glove, said electrodes are in contact with the hand palm, if the selected housing is a foot bootie, the electrodes are in contact with the foot plant and, if said selected housing is a wrist band, the electrodes are in contact with the user'"'"'s wrist.

16. A wireless system for reducing a risk of different critical situations of hypoxia and/or bradycardia comprising:

the pulse-oximeter-based device according to claim 1, and

a remote apparatus selected from the group formed by smartphones, tablets, PCs, and Internet interfaces communicating with cloud services, wherein;

said device is designed to receive and transmit wireless information to said remote apparatus,

said remote apparatus contains a remote control program specifically designed for analyzing the information sent by said pulse-oximeter-based device and to allow a remote caregiver to set timer parameters and stimulation current limits in said device.

17. The wireless system according to claim 16, wherein said remote control program allows the remote caregiver to remotely set the pulse-oximeter-based device in a stand-by mode.

18. The wireless system according to claim 16, wherein said remote control program allows the remote caregiver to send an order to the pulse-oximeter-based device to deliver electrical stimulation to the user for testing his/her reaction.

19. A method of reducing false alarms in a wearable pulse-oximeter-based device applicable to the hand or foot of a user, said device designed to measure blood oxygen saturation and heart rate values, intended to reduce critical situations of hypoxia and/or bradycardia that may happen in SIDS episodes, and designed to deliver electrical stimulus to the user with a timing pattern and an intensity pattern in order to cause a reaction of the user when a) said device stops measuring heart rate values or blood oxygen saturation values, b) heart rate measurement generates values below a first corresponding predefined limit level, or c) blood oxygen saturation measurement generates values below a second predefined limit level, said method comprising:

receiving said blood oxygen saturation and heart rate values, and

carrying out checking routines, based on user predefined parameters and a programed flow chart, to verify correct placement of the device on a body of the user and the normal operation of the device and setting adequate delays in the device'"'"'s stimulus deliverance when measuring low heart rate or blood oxygen saturation values.

20. The method according to claim 19, further comprising:

measuring a first lapsed time (t1), by way of a first timer, from a moment said heart rate measurements fall below a first user-settable limit, said first lapsed time (t1) being related to a first predefined time limit (T1), and measuring a second lapsed time, by way of a second timer, from a moment said sensor stops measuring any heart rate values at all, said second lapsed time (t2) related to a second predefined time limit (T2), and

measuring a third lapsed time (t3), by way of a third timer, from a moment said blood oxygen saturation measurements fall below a second user-settable limit, said third lapsed time (t3) being related to a third predefined time limit (T3), and measuring a fourth lapsed time (t4) by ways of a fourth timer, from a moment said sensor stops measuring any blood oxygen saturation values at all, said fourth lapsed time (t4) being related to a fourth predefined time limit (T4).

21. The method according to claim 20, wherein:

if the device does not measure any heart rate value at all and if the second timer is OFF, the device turns the second timer ON and checks if the first timer is also ON, and, if the first timer is not ON, the device checks if the second lapsed time (t2) has reached the second time limit (T2),

if the second lapsed time (t2) has not reached the second time limit yet, the device returns to measuring the heart rate, but if the second lapsed time (t2) reached the second time limit (T2), the device delivers an electrical stimulus to the user,

if the device does not measure any heart rate value at all and if the second timer is OFF, the device turns the second timer ON and checks if the first timer is also ON, and, if the first timer is ON, the device adds the first and second lapsed times (t1+t2) of the first and second timers, and

if the value resulting from adding the first and second lapsed times (t1+t2) is equal or greater than the first time limit (T1) of the first timer, the device delivers an electrical stimulus to the user, but if the value resulting from adding both first and second lapsed times (t1+t2) is smaller than the first time limit (T1) of the first lapsed time (t1), the device returns to measuring the heart rate again

22. The method according to claim 20, wherein:

if the device measures heart rate values, the device checks if the measured heart rate value is below its predetermined limit, and, if this is not verified, the device turns both of the first and second timers OFF and returns to measuring the heart rate again,

if the device measures heart rate values, the device checks if the measured heart rate value is below its predetermined limit, and if this is confirmed, the first timer is turned ON and an algorithm checks the correct operation of the device by checking if the second timer is turned ON,

if the second timer is OFF, the device checks if the first lapsed time of the first timer is equal or greater than the first time limit (T1), and if this is not verified, the device turns back to measuring heart rate

if the first lapsed time (t1) of the first timer reaches the first time limit (T1), the device delivers an electrical stimulus to the user,

if the device measures heart rate values, the device checks if the measured heart rate value is below its predetermined limit, and if this is verified, the first timer is turned ON and the algorithm checks the correct operation of the device by checking if the second timer is turned ON, and the first lapsed time (t1) of the first timer is added to the second lapsed time (t2) of the second timer, and

if value resulting from adding both first and second lapsed times (t1+t2) is equal or greater than the first time limit (T1) of the first timer, the device delivers an electrical stimulus to the user, but if the value resulting from adding both first and second lapsed times (t1+t2) is smaller than the first time limit (T1) of the first timer, the device returns to measuring the heart rate.

23. The method according to claim 20, wherein:

if the device does not measure any blood oxygen saturation value at all and if the fourth timer is OFF, the device turns the fourth timer ON and checks if the third timer is also ON,

if the third timer is not ON, the device checks if the fourth lapsed time (t4) of the fourth timer has reached the fourth time limit (T4), and, if the fourth lapsed time (t4) of the fourth timer has not yet reached the fourth time limit (T4), the device returns to measuring the blood oxygen saturation, but if the fourth lapsed time (t4) of the fourth timer has reached the fourth time limit (T4), the device delivers an electrical stimulus to the user,

if the device does not measure any blood oxygen saturation value at all and if the fourth timer is OFF, the device turns the fourth timer ON and checks if the third timer is also ON, and, if the third timer is ON, the third lapsed time (t3) of the third timer is added to the fourth lapsed time (t4) of the fourth timer, and

if the value resulting from adding both the third and fourth lapsed times (t3+t4) is equal or greater than the third time limit (T3) of the third timer, the device delivers an electrical stimulus to the user, but if the value resulting from adding both the third and fourth lapsed times (t3+t4) is smaller than the third time limit (T3) of the third timer, the device returns to measuring the blood oxygen saturation.

24. The method according to claim 20, wherein:

if the device measures blood oxygen saturation values, the device checks if the measured blood oxygen saturation value is below a predetermined limit, and if this is not verified, the device turns both of the third and fourth timers OFF, and the device returns to measuring the blood oxygen saturation,

if the device measures blood oxygen saturation values, the device checks if the measured blood oxygen saturation value is below the predetermined limit, and, if this is confirmed, the third timer is turned ON and the algorithm checks for correct operation of the device by checking if the fourth timer is turned ON,

if the fourth timer is OFF, the device checks if the third lapsed time (t3) of the third timer is equal or greater than its third time limit T3, and if this is not verified, the device turns back to measuring blood oxygen saturation,

if the third lapsed time (t3) of the third timer reaches the third time limit (T3), the device delivers an electrical stimulus to the user,

if the device measures blood oxygen values, the device checks if the measured blood oxygen saturation value is below its predetermined limit, and if this is verified, the third timer is turned ON and the algorithm checks the correct operation of the device by checking if the fourth timer is turned ON, and the third lapsed time (t3) of the third timer is added to the fourth lapsed time (t4) of the fourth timer, and

if the value resulting from adding both the third and fourth lapsed times (t3+t4) is equal or greater than the first time setting T3 of the first timer, the device delivers an electrical stimulus to the user, but if the value resulting from adding both lapsed times (t3+t4) is smaller than the first time setting T3 of the first timer, the device returns to measuring the blood oxygen saturation.

25. The method according to claim 21, wherein:

after delivering a first electrical stimulus, the device sends out a first alarm, waits 10 seconds, and checks if a heart rate value or a blood oxygen saturation value was measured, and, if not, the device delivers an electrical stimulus to the user, activates the second timer, and waits another 10 seconds before checking again for existence of a measured heart rate value or a blood oxygen saturation value,

if measurement of a heart rate value or a blood oxygen saturation value is confirmed, the device checks if the heart rate is below its safe limit and if the blood oxygen saturation value is also below its safe limit, and, if any of these situations are confirmed, the device delivers a second electrical stimulation, sends out a second alarm, and returns to measurement of a heart rate value or a blood oxygen saturation value.

26. The method according to claim 25, wherein:

after the second electrical stimulation, the device delivers further stimulus signals increasing a discharge current in preset current steps until reaching a maximum preset safety limit, and

said safety limit is selected according to an age and a weight of the user.

27. The method according to claim 26, wherein a total stimulus signal current range is 0.01 mA to 5.0 mA, and a maximum operation time is 3 minutes.

28. The method according to claim 19, further comprising wirelessly transmitting alarms to devices selected from a group formed by smartphones, tablets, PCs, and Internet interfaces communicating with cloud services.

29. The method according to claim 19, further comprising measuring human body temperature.

30. The method according to claim 19, further comprising delivering the electrical stimulus via a finger of the user when the device is housed in a ring, delivering the electrical stimulus via a hand palm when the device is housed in a hand glove, delivering the electrical stimulus via a foot plant when the device is housed in a foot bootie, and delivering the electrical stimulus via a wrist when the device is housed is a wrist band.