Method and device for sleep analysis

• US 10,028,698 B1
• Filed: 10/15/2015
• Issued: 07/24/2018
• 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): Downey, John R
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US14/883,687
• Time in Patent Office: 1,013 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) applying, at least two sensors to a patient located in a facility remote to a sleep analysis unit or lab, the at least two sensors including a respiratory belt sensor and a patient airflow sensor, the respiratory belt sensor being electrically hardwired and releasably connected to a portable patient interface box worn or carried by the patient, and the airflow sensor internal to the same patient interface box and adapted to be applied to the patient through a nasal cannula or breathing mask, which is connected to the patient interface box by an air port;

b) connecting both the respiratory belt sensor, and the nasal cannula or breathing mask directly to the patient interface box, which is part of a portable wireless data acquisition system comprising the patient interface box and a cellular phone, the patient interface box further comprising electronics, which are programmed to collect and transmit data to the cellular phone, the cellular phone having a first electronic interface for receiving the data, the cellular phone which is programmed to transmit data to an second electronic interface for receiving the data for review by medical personnel;

c) collecting data with the electronics of the patient interface box in real-time from the at least two sensors on the patient located in the remote facility while the patient is attempting to sleep;

d) transmitting, at least in part, the data from the patient interface box to the cellular phone;

e) transmitting wirelessly the data, at least in part, from the cellular phone to the sleep analysis unit or lab, or to a database accessible to medical personnel located remote from the patient through the electronic interface;

f) analyzing the data with a computer or processor programmed to identify and draw attention to physiological and technological events in the data;

g) further medical analysis of the transmitted data and the physiological and technological events in the data to medically diagnose whether the patient suffers from a sleep disorder; and

h) communicating the diagnosis to the patient.

2. The method of claim 1, further including the step checking the adequacy of the data with a processor from the respiratory belt sensor and the air flow sensor prior to transmitting the data.

3. The method of claim 2, further including the step of determining whether the patient being analyzed for a sleep disorder maintained a normal sleeping pattern prior to the analysis.

4. The method of claim 2, further including the step of having a remotely attended sleep analysis, wherein the patient, their assistant or an individual near the patient can be communicated with to provide instructions during the sleep analysis using a device associated with the patient, the assistant or the individual near the patient.

5. The method of claim 2, wherein movement artifacts caused by patient movement are removed using the processor or a second processor and data from a third sensor internal to the data acquisition box using a frequency analysis, at least in part, from or in the data prior to medical diagnosis.

6. The method of claim 2, wherein at least four sensors are used all being connected to the patient interface box, and further including an accelerometer internal to the patient interface box for measuring patient movement and a pulse oximeter wherein the patient interface box and sensors weigh less than 5 lbs.

7. A method of remote sleep analysis and diagnosis comprising the steps of:

a) applying at least two sensors to a patient located in a facility remote to a sleep analysis unit or lab, the at least two sensors including a respiratory belt sensor and a patient airflow sensor, the respiratory belt sensor being electrically hardwired and releasably connected to a portable patient interface box worn or carried by the patient and the airflow sensor internal to the same patient interface box and adapted to be applied to the patient through a nasal cannula or breathing mask;

b) connecting both the respiratory belt sensor and the nasal cannula or breathing mask directly to the patient interface box further comprising electronics, which are programmed to collect and transmit data to an electronic interface for receiving the data for review by medical personnel;

c) collecting data with the electronics of the patient interface box in real-time from the at least two sensors on the patient located in the remote facility while the patient is attempting to sleep;

d) transmitting wirelessly, at least in part, the data to the sleep analysis unit or lab or to a database accessible to medical personnel located remote from the patient through the electronic interface;

e) analysis of the data with a computer or processor programmed to identify and draw attention to physiological and technological events in the data;

f) further medical analysis of the transmitted data and the physiological and technological events in the data to medically diagnose whether the patient suffers from a sleep disorder; and

g) communicating the diagnosis to the patient.

8. The method of claim 7, further including the step checking the adequacy of the data collected from the respiratory belt sensor and the air flow sensor with a processor prior to transmitting the data.

9. The method of claim 7, further including the step of determining whether the patient being analyzed for a sleep disorder maintained a normal sleeping pattern prior to the analysis.

10. The method of claim 7, further including the step of having a remotely attended sleep analysis, wherein the patient, their assistant or an individual near the patient can be communicated with to provide instructions during the sleep analysis using a device associated with the patient, the assistant or the individual near the patient.

11. The method of claim 7, wherein movement artifacts caused by patient movement are removed using the processor or a second processor and data from a third sensor internal to the data acquisition box using a frequency analysis, at least in part, from or in the data prior to medical diagnosis.

12. The method of claim 7, wherein at least four sensors are used all being connected directly to the patient interface box, and further including an accelerometer internal to the patient interface box for measuring patient movement and a pulse oximeter wherein the patient interface box and sensors weigh less than 5 lbs.

13. The method of claim 12, wherein at least five sensors are used further including a second respiratory belt, with one respiratory belt positioned at the patient'"'"'s axilla and the second respiratory belt at the patient'"'"'s umbilicus.

14. A method of remote sleep analysis and diagnosis comprising the steps of:

a) applying at least two sensors to a patient located in a facility remote to a sleep analysis unit or lab, the at least two sensors including a respiratory belt sensor and a patient airflow sensor, the respiratory belt sensor being electrically hardwired and releasably connected to a portable patient interface box worn or carried by the patient, and the airflow sensor internal to the same patient interface box and adapted to be applied to the patient through a nasal cannula or breathing mask;

b) connecting both the respiratory belt sensor and the nasal cannula or breathing mask directly to the patient interface box further comprising a memory device, a battery, and electronics, which are programmed to collect and transmit data to an electronic interface for receiving the data for review by medical personnel;

c) collecting data with the electronics of the patient interface box in real-time from the at least two sensors on the patient located in the remote facility while the patient is attempting to sleep;

d) storing the data from both the respiratory effort sensor and the air flow sensor on the memory device of the patient interface box;

e) transmitting the data from the memory of the patient interface box to the electronic interface via cellular systems, internet, satellite, wired-network and/or land lines to the sleep analysis unit or lab or to a database accessible to medical personnel;

f) analyzing the transmitted data with a computer or processor to identify and draw attention to physiological and technological events in the data;

g) further medical analysis of the transmitted data and the physiological and technological events in the data to medically diagnose whether the patient suffers from a sleep disorder; and

h) communicating the diagnosis to the patient.

15. The method of claim 14, further including the step checking the adequacy of the data from the respiratory belt sensor and the air flow sensor with a processor prior to transmitting the data.

16. The method of claim 14, further including the step of determining whether the patient being analyzed for a sleep disorder maintained a normal sleeping pattern prior to the analysis.

17. The method of claim 14, further including the step of having a remotely attended sleep analysis, wherein the patient, their assistant or an individual near the patient can be communicated with to provide instructions during the sleep analysis using a device associated with the patient, the assistant or the individual near the patient.

18. The method of claim 14, wherein movement artifacts caused by patient movement are removed using the processor or a second processor and data from a third sensor internal to the data acquisition box using a frequency analysis, at least in part, from or in the data prior to medical diagnosis.

19. The method of claim 14, wherein at least four sensors are used all being connected to the patient interface box, and further including an accelerometer internal to the patient interface box for measuring patient movement and a pulse oximeter wherein the patient interface box and sensors weigh less than 5 lbs.

20. The method of claim 19, wherein at least five sensors are used further including a second respiratory belt, with one respiratory belt positioned at the patient'"'"'s axilla and the second respiratory belt at the patient'"'"'s umbilicus.