US 11,883,189 B1
Method and device for in-home sleep and signal analysis
Hani Kayyali, Shaker Heights, OH (US); Craig A. Frederick, Solon, OH (US); Christian Martin, Eden, NC (US); Robert N. Schmidt, Ft. Myers, FL (US); and Brian Kolkowski, Leroy, OH (US)
Assigned to Cleveland Medical Devices Inc., Cleveland, OH (US)
Filed by Cleveland Medical Devices Inc., Cleveland, OH (US)
Filed on Jun. 30, 2023, as Appl. No. 18/216,715.
Application 18/216,715 is a continuation of application No. 18/094,440, filed on Jan. 9, 2023, granted, now 11,730,422.
Application 18/094,440 is a continuation of application No. 17/948,275, filed on Sep. 20, 2022, granted, now 11,602,305, issued on Mar. 14, 2023.
Application 17/948,275 is a continuation of application No. 17/835,017, filed on Jun. 8, 2022, granted, now 11,478,188, issued on Oct. 25, 2022.
Application 17/835,017 is a continuation of application No. 17/551,678, filed on Dec. 15, 2021, granted, now 11,382,562, issued on Jul. 12, 2022.
Application 17/551,678 is a continuation of application No. 17/346,640, filed on Jun. 14, 2021, granted, now 11,234,637, issued on Feb. 1, 2022.
Application 17/346,640 is a continuation of application No. 17/145,661, filed on Jan. 11, 2021, granted, now 11,064,937, issued on Jul. 20, 2021.
Application 17/145,661 is a continuation of application No. 16/233,520, filed on Dec. 27, 2018, granted, now 10,925,535, issued on Feb. 23, 2021.
Application 16/233,520 is a continuation of application No. 15/229,242, filed on Aug. 5, 2016, granted, now 10,426,399, issued on Oct. 1, 2019.
Application 15/229,242 is a continuation of application No. 11/811,156, filed on Jun. 8, 2007, abandoned.
Int. Cl. A61B 5/00 (2006.01); A61B 5/389 (2021.01); A61B 5/318 (2021.01); A61B 5/0205 (2006.01); A61B 5/11 (2006.01); G16H 40/67 (2018.01); A61B 5/1455 (2006.01); A61B 5/398 (2021.01); A61B 5/369 (2021.01); A61B 5/08 (2006.01); A61B 5/024 (2006.01); A61B 5/087 (2006.01); A61B 5/113 (2006.01); A61B 5/085 (2006.01)
CPC A61B 5/4815 (2013.01) [A61B 5/0022 (2013.01); A61B 5/0077 (2013.01); A61B 5/0205 (2013.01); A61B 5/0806 (2013.01); A61B 5/1114 (2013.01); A61B 5/14551 (2013.01); A61B 5/318 (2021.01); A61B 5/369 (2021.01); A61B 5/389 (2021.01); A61B 5/398 (2021.01); A61B 5/4812 (2013.01); A61B 5/4818 (2013.01); A61B 5/6801 (2013.01); A61B 5/6814 (2013.01); A61B 5/6828 (2013.01); A61B 5/7264 (2013.01); G16H 40/67 (2018.01); A61B 5/024 (2013.01); A61B 5/085 (2013.01); A61B 5/087 (2013.01); A61B 5/1135 (2013.01); A61B 5/14552 (2013.01); A61B 2505/07 (2013.01); A61B 2560/0242 (2013.01); A61B 2560/0431 (2013.01); A61B 2562/0219 (2013.01); A61B 2562/0261 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A sleep diagnostic system for testing multiple subjects at multiple remote locations for sleep apnea comprising:
a) a first software stored on a first non-transitory computer readable medium and adapted to be executable by a first processor on a cellular phone, the cellular phone comprising a memory, the first processor and a first wireless transceiver;
b) a database stored on a second non-transitory computer readable medium adapted to operate with one or more servers at a first or multiple locations for receiving and transmitting data to and from the database;
c) a second software stored on the second, and/or a third non-transitory computer readable medium and adapted to be executable by a second processor at the first location, a second location and/or the multiple locations configured to process, in part, the data;
d) multiple portable, wearable patient interface boxes, each portable, wearable patient interface box adapted to be worn by a subject during testing at a remote sleep location remote from a sleep analysis unit or lab, and the first, the second and/or the multiple locations where the database and/or the second software are operating, one or more of the multiple portable, wearable patient interface boxes comprising
i) a battery;
ii) electronics including at least two input channels, which are programmed to receive collected data in real-time from at least two sensors internal to the portable, wearable patient interface box; and
iii) a second wireless transceiver or transmitter adapted to wirelessly transmit the data collected from the two sensors internal to the portable, wearable patient interface box, and/or data based on the data collected to the first software on the cellular phone;
e) the two sensors are selected from a group consisting of: accelerometer(s), fingertip pulse oximeter(s), pressure sensor(s), microphone(s), strain gauge(s), pressure transducer(s), and transducer(s), the portable, wearable patient interface box containing the two sensors adapted
i) to be applied to a finger, wrist, arm or torso of the subject; and
ii) to allow to be measured, calculated and/or derived two or more of the following sleep data: airflow, snore, changes in pulse, changes in heart rate, changes in sleep state, respiratory effort, body movement and/or position, tidal volume, ventilation rate and blood oxygenation of the subject during testing;
f) the database being accessible to individuals from the sleep analysis unit or lab, and adapted to receive the collected data and/or data based on the collected data;
g) the first software and/or the second software when executed respectively by the first and/or second processors is configured to automatically identify and quantify physiological events in one or more of the changes in pulse and/or heart rate, body position, and blood oxygenation, from the data that was transferred from the portable, wearable patient interface box, the physiological events indicative of a sleeping disorder, the second software further adapted to be executed by the one second processor to output through a communication device; and
h) the communication device adapted to output
i) one or more of the following sleep data: airflow, snore, changes in pulse, changes in heart rate, changes in sleep state, respiratory effort, body movement and/or position, tidal volume, ventilation rate and blood oxygenation of the subject from the database,
ii) the identified and quantified physiological events in the data, or
iii) both i) and ii) in a form adapted so a professional medical diagnosis can be made of whether the patient suffers from a sleep disorder.