# US 11,908,567 B1 · Sleep diagnostic system for the testing of multiple subjects being tested at remote locations

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- Number: US 11,908,567 B1
- Document ID: US11908567B1
- Status: Granted
- Kind: B1
- Application number: 18/196,604
- Filed: 2023-05-12
- Granted: 2024-02-20
- Earliest claimed: 2007-06-08
- Assignees: Cleveland Medical Devices Inc.
- Applicants: Cleveland Medical Devices Inc.
- Inventors: Hani Kayyali; Craig A. Frederick; Robert N. Schmidt; Brian M. Kolkowski
- Web page: https://patentgrep.com/patent/US11908567B1

## CPC

- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- A61B 5/0004: {characterised by the type of physiological signal transmitted}
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/087: Measuring breath flow
- A61B 5/14552: {Details of sensors specially adapted therefor}
- A61B 5/372: Analysis of electroencephalograms
- A61B 5/4806: {Sleep evaluation (A61B5/4821 takes precedence; devices for inducing sleep A61M21/02)}
- A61B 5/4815: {Sleep quality}
- A61B 5/4818: {Sleep apnoea}
- A61B 5/486: {Biofeedback (using electroencephalography [EEG] A61B5/375)}
- A61B 5/6831: {Straps, bands or harnesses}
- A61B 5/721: {using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- G16H 40/20: for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
- G16H 40/67: for remote operation
- A61B 2560/0214: of power generation or supply
- A61B 2560/0475: Special features of memory means, e.g. removable memory cards
- A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The various embodiments of the method of the present invention include a method to improving or expanding the capacity of a sleep analysis unit or laboratory, a method sleep analysis testing a patient admitted for diagnosis or treatment of another primary medical condition while being treated or diagnosed for that condition, a method of sleep analysis testing a patient that cannot be easily moved or treated in a sleep analysis unit or laboratory and other like methods.

## Claims

### Claim 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 second 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 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, which are programmed to check the data for adequacy and receive collected data in real-time from at least three sensors for storage in the digital memory;
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 allow to be measured, calculated and/or derived 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 two sensor connectors 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, the first software further adapted to be executed by a processor at the first location, another processor at the second location or on multiple processors at multiple locations each location different than the remote sleep location; and
g) a communication device adapted to output:
i) the collected data or data based on the collected data, at least in part, from the database,
ii) the identified and quantified physiological events in the data, at least in part, 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.

### Claim 2 (depends on 1)

The sleep diagnostic system in claim 1, wherein the system is configured to interface with multiple portable, wearable patient interface boxes with different sensor configurations.

### Claim 3 (depends on 1)

The sleep diagnostic system in claim 1, wherein the database, for receiving the collected data or the data based on the collected data, is configured to operate with the one or more servers being in a different country from the remote sleep location of the subject.

### Claim 4 (depends on 1)

The sleep diagnostic system in claim 1, wherein the database, for receiving the collected data or the data based on the collected data, is configured to operate with the one or more servers being in a different state from the remote sleep location of the subject.

### Claim 5 (depends on 1)

The sleep diagnostic system of claim 1, wherein the sleep diagnostic system is configured to further employ a form of frequency hopping to avoid interference and improve security.

### Claim 6 (depends on 5)

The sleep diagnostic system of claim 5, wherein the sleep diagnostic system uses a secured data transmission system adapted to allow an encryption scheme on the secured data transmission system to be changed remotely.

### Claim 7 (depends on 2)

The sleep diagnostic system in claim 2, wherein a third of the at least three sensors measures airflow and comprises a nasal cannula or a facemask, a first pressure sensor or pressure transducer internal to at least one of the portable, wearable patient interface boxes, and a first air port adapted for connecting the nasal cannula or facemask to the first pressure sensor.

### Claim 8 (depends on 7)

The sleep diagnostic system in claim 7, wherein the second of the at least three sensors measures respiratory effort and comprises a respiratory effort belt, a second pressure sensor or pressure transducer internal to the at least one of the portable, wearable patient interface boxes, and a second air port adapted for connecting the respiratory effort belt to the second pressure sensor or pressure transducer.

### Claim 9 (depends on 1)

The sleep diagnostic system in claim 1, wherein the database is configured to allow the data from the database to be sent to one or multiple review stations anywhere in the world via the Internet or other communications systems for further analysis and review by clinicians, technicians, researchers, doctors and the like.

### Claim 10 (depends on 1)

The sleep diagnostic system in claim 1, wherein the data from the database is configured to be further provided from the database for clinical and research studies and a sleep signature is determined at least in part from the data on the database for sleeping disorders or other diseases.

### Claim 11 (depends on 10)

The sleep diagnostic system in claim 10, wherein the data from the database is configured to be further provided from the database for clinical and research studies and a sleep signature is determined at least in part from the data for one or more diseases from the group consisting of Parkinson's, epilepsy, chronic obstructive pulmonary disorder, neurological disorders, pulmonary disorders, and muscular disorders.

### Claim 12 (depends on 1)

The sleep diagnostic system in claim 1, wherein the at least first software further includes an algorithm adapted for identifying changes in sleep stages, a heart or pulse rate, and calculating an index indicative of a subject's sleep apnea using the collected and transferred data prior to medical diagnosis.

### Claim 13 (depends on 8)

The sleep diagnostic system in claim 8, wherein the at least first software further includes an algorithm adapted for identifying changes in sleep stages, a heart or pulse rate, and calculating an index indicative of a subject's sleep apnea using the collected and transferred data prior to medical diagnosis.

### Claim 14 (depends on 12)

The sleep diagnostic system in claim 12, further comprising a second software, the first software, and/or a website with computer assisted scoring and are further configured to allow a technician or clinician to manually score the data from the database.

### Claim 15 (depends on 13)

The sleep diagnostic system in claim 13, further comprising a second software, the first software, and/or a website with computer assisted scoring and are further configured to allow a technician or clinician to manually score the data from the database.

### Claim 16 (depends on 12)

The sleep diagnostic system in claim 12, wherein the transceiver is further adapted to upload the data from the memory and/or through a connection with a cellular phone or a cellular card on the portable, wearable patient interface box via cellular systems to the database.

### Claim 17 (depends on 13)

The sleep diagnostic system in claim 13, wherein the transceiver is further adapted to upload the data from the memory and/or through a connection with a cellular phone via cellular systems, Internet, satellite, wired-network and/or land lines to the database.

### Claim 18 (depends on 1)

The sleep diagnostic system in claim 1, wherein the sleep disorder system is further configured to control the encoding of the data that is transmitted to optimize utilization on any given network being used to transfer the data.

### Claim 19 (depends on 2)

The sleep diagnostic system in claim 2, wherein the sleep disorder system is further configured to control the encoding of the data that is transmitted to optimize utilization on any given network being used to transfer the data.

### Claim 20 (depends on 15)

The sleep diagnostic system in claim 15, wherein the sleep disorder system is further configured to control the encoding of the data that is transmitted to optimize utilization on any given network being used to transfer the data.