Method and device for sleep analysis

• US 10,478,118 B1
• Filed: 06/21/2018
• Issued: 11/19/2019
• Est. Priority Date: 06/08/2007
• Status: Active Grant

• Current Assignee: Cleveland Medical Devices Inc.
• Original Assignee: Cleveland Medical Devices Inc.
• Inventors: Frederick, Craig A, Kayyali, Hani, Schmidt, Robert N., Kolkowski, Brian M.
• Primary Examiner(s): Fairchild, Mallika D
• Assistant Examiner(s): Jian, Shirley X
• Application Number:
  US16/014,002
• Time in Patent Office: 516 Days
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/67 for remote operation

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.