US 11,688,503 B1
Method and device for sleep analysis
Hani Kayyali, Shaker Heights, OH (US); Craig A. Frederick, Solon, OH (US); Robert N. Schmidt, Ft. Myers, FL (US); and Brian M. Kolkowski, Leroy, OH (US)
Assigned to Cleveland Medical Devices Inc., Cleveland, OH (US)
Filed by Cleveland Medical Devices Inc., Cleveland, OH (US)
Filed on Jan. 9, 2023, as Appl. No. 18/94,539.
Application 18/094,539 is a continuation of application No. 17/948,301, filed on Sep. 20, 2022, granted, now 11,576,610.
Application 17/948,301 is a continuation of application No. 17/837,104, filed on Jun. 10, 2022, granted, now 11,484,255, issued on Nov. 1, 2022.
Application 17/837,104 is a continuation of application No. 17/704,085, filed on Mar. 25, 2022, granted, now 11,395,623, issued on Jul. 26, 2022.
Application 17/704,085 is a continuation of application No. 17/515,866, filed on Nov. 1, 2021, granted, now 11,317,856, issued on May 3, 2022.
Application 17/515,866 is a continuation of application No. 16/599,330, filed on Oct. 11, 2019, granted, now 11,202,603, issued on Dec. 21, 2021.
Application 16/599,330 is a continuation of application No. 16/014,002, filed on Jun. 21, 2018, granted, now 10,478,118, issued on Nov. 19, 2019.
Application 16/014,002 is a continuation of application No. 14/883,687, filed on Oct. 15, 2015, granted, now 10,028,698, issued on Jul. 24, 2018.
Application 14/883,687 is a continuation of application No. 11/811,157, filed on Jun. 8, 2007, granted, now 9,202,008, issued on Dec. 1, 2015.
This patent is subject to a terminal disclaimer.
Int. Cl. A61B 5/00 (2006.01); G16H 20/40 (2018.01); G16H 40/20 (2018.01); G16H 40/67 (2018.01); A61B 5/369 (2021.01); A61B 5/087 (2006.01); A61B 5/1455 (2006.01)
CPC G16H 20/40 (2018.01) [A61B 5/0004 (2013.01); A61B 5/0006 (2013.01); A61B 5/0022 (2013.01); A61B 5/087 (2013.01); A61B 5/14552 (2013.01); A61B 5/369 (2021.01); A61B 5/4806 (2013.01); A61B 5/486 (2013.01); A61B 5/4815 (2013.01); A61B 5/6831 (2013.01); A61B 5/721 (2013.01); A61B 5/7282 (2013.01); G16H 40/20 (2018.01); G16H 40/67 (2018.01); A61B 2560/0214 (2013.01); A61B 2560/0475 (2013.01); A61B 2562/0219 (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 database stored on a first non-transitory computer readable medium configured to operate with one or more servers at a first or multiple locations for receiving and transmitting data to and from the database;
b) an at least first software stored on a non-transitory computer readable medium and configured to be executable by a processor at the first location, a second location and/or the multiple locations configured to process, in part, the data to be stored in the database;
c) multiple portable, wearable patient interface boxes, each portable, wearable patient interface box adapted to be worn by a subject during testing for sleep apnea at a remote sleep location remote from a sleep analysis unit or lab, and the first, the second and the multiple locations where the database and the at least first software are operating, one or more of the multiple portable, wearable patient interface boxes comprising
i) a battery;
ii) a digital memory;
iii) electronics including at least three input channels configured to receive collected data in real-time from at least three sensors for storage in the digital memory, and programed to check the collected data for adequacy;
iv) a transceiver or a transmitter adapted to upload the collected data, and/or data based on the collected data to the at least first software and/or the database; and
v) at least two sensor connectors adapted to electrically connect the at least three sensors directly to and/or within the portable, wearable patient interface box;
d) the at least three sensors are selected from a group consisting of: accelerometer(s), fingertip pulse oximeter(s), rip belt(s), respiratory effort belt(s), pressure sensor(s), microphone(s), strain gauge(s), pressure transducer(s), and transducer(s), the at least three sensors adapted
i) to be applied to the subject, a first and a second of the at least three sensors adapted to be applied to a finger, wrist, arm and/or torso of the subject;
ii) to measure, calculate, and/or derive three or more of the following sleep data: airflow, snore, changes in pulse, changes in heart rate, changes in sleep state, respiratory effort, body position, tidal volume, ventilation rate and blood oxygenation of the subject during testing; and
iii) to be electrically hardwired and/or releasably connected to the at least three input channels on and/or within the portable, wearable patient interface box adapted to be worn by the subject;
e) 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 from the memory of the portable, wearable patient interface box uploaded to the first software and/or the one or more servers associated with the database through the transceiver or the transmitter on the portable, wearable patient interface box;
f) the first software when executed by the processor is configured to automatically identify and quantify physiological events in the sleep data including determining a respiratory disturbance index from the data that was transferred from the portable, wearable patient interface box, the physiological events indicative of a sleeping disorder; and
g) a communication device adapted to output
i) a body position and blood oxygenation data 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.