# US 10,368,800 B2 · Systems, methods and devices for diagnosing sleep apnea

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- Number: US 10,368,800 B2
- Document ID: US10368800B2
- Status: Granted
- Kind: B2
- Application number: 15/409,358
- Filed: 2017-01-18
- Published: 2017-05-04
- Granted: 2019-08-06
- Earliest claimed: 2013-08-15
- Applicants: Chunyuan Qiu
- Inventors: Chunyuan Qiu
- Web page: https://patentgrep.com/patent/US10368800B2

## CPC

- A61B 5/4818: {Sleep apnoea}
- A61B 1/233: for the nose, i.e. nasoscopes {, e.g. testing of patency of Eustachian tubes}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/004: {adapted for image acquisition of a particular organ or body part (A61B5/0082 takes precedence; arrangements for optical scanning A61B5/0062)}
- A61B 5/0086: {using infrared radiation}
- A61B 5/015: {By temperature mapping of body part}
- A61B 5/0826: {Detecting or evaluating apnoea events (sleep apnoea A61B5/4818)}
- A61B 5/0836: {Measuring rate of CO2 production}
- A61B 5/085: Measuring impedance of respiratory organs or lung elasticity
- A61B 5/087: Measuring breath flow
- A61B 5/097: Devices for facilitating collection of breath or for directing breath into or through measuring devices
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/33: specially adapted for cooperation with other devices
- A61B 5/6853: {with a balloon}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots}
- A61B 7/003: {Detecting lung or respiration noise}
- A61B 7/023: {for introduction into the body, e.g. into the oesophagus (oesophageal ECG probes A61B5/285)}
- A61B 7/04: Electric stethoscopes
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Methods for diagnosing sleep apnea are provided herein. In at least one example, a method may be provided including receiving airway image data from a remote end imaging sensor coupled to a nasal tube disposed within an upper airway above a constriction point, and analyzing the airway image data and displaying in a sleep study report the airway image data to identify airway closures related to obstructive sleep apnea.

## Claims

### Claim 1

A method for monitoring an upper airway constriction associated with obstructive sleep apnea, comprising:
forming a seal between a wall defining an upper airway and a nasal tube disposed within the upper airway, the seal surrounding an outer circumference of the nasal tube,
flowing air through a first end, a hollow interior, and a second end of the nasal tube, where the second end is opposite the first end of the nasal tube, wherein the first end includes a nose stopper that stabilizes a position of the nasal tube;
receiving airway image data from an imaging sensor coupled to the second end of the nasal tube disposed within the upper airway, where such airway image data was recorded during a sleep period, and where the imaging sensor is positioned downstream of the seal; and
analyzing the airway image data and displaying in a sleep study report the airway image data to identify airway closures related to obstructive sleep apnea.

### Claim 2 (depends on 1)

The method of claim 1, further comprising receiving biophysical data from one or more of: an oxygen saturation sensor, capnography sensors for determining a gas level or exchange rate within an airway during the sleep period, and a sound-detecting device, and analyzing the biophysical data and displaying the biophysical data in the sleep study report.

### Claim 3 (depends on 1)

The method of claim 1, further comprising receiving head position data from a sensor that indicates a head position relative to the nasal tube and analyzing the head position data and displaying the head position data in the sleep study report.

### Claim 4 (depends on 1)

The method of claim 1, further comprising receiving airflow data, analyzing the airflow data and displaying the airflow data in the sleep study report of the airflow data.

### Claim 5 (depends on 1)

The method of claim 1, wherein the seal is formed via an inflatable balloon that expands to a diameter greater than a diameter of the nasal tube, the inflatable balloon further anchoring the nasal tube in a select position.

### Claim 6

A method for monitoring an upper airway constriction associated with obstructive sleep apnea, comprising:
placing an airway assessing apparatus such that the airway assessing apparatus extends through a nasal cavity and into an upper airway, the airway assessing apparatus including an imaging sensor and biophysical sensors, the imaging sensor facing the upper airway;
stabilizing a position of the airway assessing apparatus relative to the nasal cavity via a nose stopper;
inflating a balloon of the airway assessing apparatus to adjust a position of one or more of the imaging sensor and the biophysical sensors, the inflatable balloon surrounding an outer circumference of the airway assessing apparatus, and the inflatable balloon positioned upstream of the imaging sensor;
forming a seal between the airway assessing apparatus and a wall defining the upper airway via the inflatable balloon;
flowing air through the airway assessing apparatus;
recording a baseline measurement of the imaging sensor and the biophysical sensors;
recording data collected from the imaging sensor and biophysical sensors during a sleep period; and
analyzing the recorded baseline measurement and the recorded data collected from the imaging and biophysical sensors to identify airway closures related to obstructive sleep apnea.

### Claim 7 (depends on 6)

The method of claim 6, further comprising locally storing the recorded baseline measurement and the recorded data collected from the imaging sensor and the biophysical sensors.

### Claim 8 (depends on 6)

The method of claim 6, further comprising transmitting the recorded baseline measurement and the recorded data collected from the imaging sensor and the biophysical sensors to a remote computing device.

### Claim 9 (depends on 6)

The method of claim 6, wherein the analyzing includes performing an automatic pattern analysis on the recorded baseline measurement and the recorded data collected from the imaging sensor and the biophysical sensors.

### Claim 10 (depends on 6)

The method of claim 6, wherein the data collected from the imaging sensor is time stamped.

### Claim 11 (depends on 10)

The method of claim 10, wherein analyzing the recorded baseline measurement and the recorded data collected includes performing a temporal analysis.

### Claim 12

A method for monitoring an upper airway constriction associated with obstructive sleep apnea, comprising:
positioning a nasal tube so that the nasal tube extends through a nasal cavity and into an upper airway;
anchoring the nasal tube relative to the nasal cavity via a nose stopper;
forming a seal between a wall defining the upper airway and the nasal tube disposed within the upper airway, the seal surrounding an outer circumference of the nasal tube;
flowing air through the nasal tube;
receiving airway image data from a remote end imaging sensor coupled to the nasal tube disposed within the upper airway, the remote end imaging sensor positioned downstream of the seal, where such airway image data was recorded during a sleep period; and
automatically analyzing the airway image data with pattern matching and pattern recognition.

### Claim 13 (depends on 12)

The method of claim 12, wherein the automatic pattern matching and the pattern recognition analyses are to identify airway closures related to obstructive sleep apnea.

### Claim 14 (depends on 12)

The method of claim 12, further comprising displaying the airway image data to identify airway closures related to obstructive sleep apnea in a sleep study report.

### Claim 15 (depends on 12)

The method of claim 12, wherein the seal is formed by a balloon positioned on the nasal tube, and wherein forming the seal comprises inflating the balloon.

### Claim 16 (depends on 15)

The method of claim 15, wherein the seal formed by the balloon anchors the nasal tube in a select position in the upper airway.

### Claim 17 (depends on 16)

The method of claim 16, wherein the balloon expands to a diameter greater than a diameter of the nasal tube when inflated to form the seal.

### Claim 18 (depends on 12)

The method of claim 12, further comprising inflating a balloon that is on the nasal tube to adjust a positioning of a biophysical sensor, the biophysical sensor coupled to the nasal tube.

### Claim 19 (depends on 18)

The method of claim 18, wherein the biophysical sensor is exposed at an exterior surface of the nasal tube.

### Claim 20 (depends on 12)

The method of claim 12, further comprising receiving biophysical data from an oxygen saturation sensor and capnography sensors to determine a gas level or exchange rate within an airway during the sleep period, and analyzing the biophysical data.
