# US 10,478,118 B1 · Method and device for sleep analysis

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- Number: US 10,478,118 B1
- Document ID: US10478118B1
- Status: Granted
- Kind: B1
- Application number: 16/014,002
- Filed: 2018-06-21
- Granted: 2019-11-19
- Earliest claimed: 2007-06-08
- Assignees: Cleveland Medical Devices Inc.
- Applicants: Craig A Frederick; Hani Kayyali; Robert N. Schmidt; Brian M. Kolkowski
- Inventors: Craig A Frederick; Hani Kayyali; Robert N. Schmidt; Brian M. Kolkowski
- Web page: https://patentgrep.com/patent/US10478118B1

## 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 method of remote sleep analysis and diagnosis comprising the steps of:
a) providing a patient with a portable patient interface box adapted to be worn by the patient and a nasal cannula or a facemask, a respiratory effort belt and a fingertip pulse oximeter, the patient interface box comprising a battery, at least one kinetic sensor, a nonvolatile digital memory, first and second pressure transducers, a first air port for connecting the nasal cannula or the facemask to the first pressure transducer, a second air port for connecting the respiratory effort belt to the second pressure transducer, and a releasable connector sensor input to electrically connect and disconnect the fingertip pulse oximeter, the nasal cannula or facemask for measuring airflow of the patient, the respiratory effort belt for measuring respiratory effort of the patient, the kinetic sensor for measuring body position or orientation, and the fingertip pulse oximeter for measuring oxygenation of the patient;
b) applying and connecting the nasal cannula or facemask, the respiratory effort belt and the fingertip pulse oximeter to the patient, and further the patient interface box to the patient;
c) measuring and collecting data from the sensors through the patient interface box of the airflow, respiratory effort, body position or orientation and oxygenation of the patient in a remote sleep location from the sleep unit or lab while the patient is attempting to sleep;
d) digitizing and storing the collected data from the patient in the nonvolatile digital memory of the patient interface box;
e) to the sleep analysis unit or lab or to a database accessible to individuals from the sleep analysis unit or lab;
f) providing a computer or processor for analyzing the transferred collected data to identify and draw attention to physiological or technological events in the data indicative of a sleeping disorder; and
g) further analyzing at a minimum the transferred collected data and/or the physiological or technological events in the data at the sleep analysis unit or lab, or at a location remote from the remote sleep location to determine whether the patient suffers from a sleeping disorder.

### Claim 2 (depends on 1)

The method in claim 1, further including a step of determining that the patient has maintained a normal sleeping pattern prior to the analysis based on subjective input from the subject or polysomnography data.

### Claim 3 (depends on 1)

The method in claim 1, further including a step of providing a computer or processor at the patient's location for checking the adequacy of the collected data from the sensors prior to a transferring the collected data to the sleep analysis unit or lab or to a database accessible to individuals from the sleep analysis unit or lab.

### Claim 4 (depends on 1)

The method in claim 1, wherein the patient interface box is capable of two way communication between the patient or their care provider and a sleep trained individual at the remote location.

### Claim 5 (depends on 1)

The method in claim 1, further comprising a step of at least in part removing or identifying movement artifacts in the collected data prior to the computer or processor analysis of the collected data by an algorithm of the computer or processor comparing signals from a fourth sensor for detecting body movement with at least one of the at least three sensors to identify and/or remove movement artifacts identified from the signals.

### Claim 6 (depends on 1)

The method in claim 1, wherein data or the data based on collected data is transferred by an electronic interface via cellular systems, internet, satellite, wired-network and/or land lines to the sleep analysis unit or lab or to the database accessible to medical personnel.

### Claim 7 (depends on 1)

The method in claim 1, wherein the transferred data is transmitted wirelessly between the remote sleep location and the sleep analysis unit or lab or to the database accessible to medical personnel.