# US 9,750,909 B2 · System and method for diagnosis and treatment of a breathing pattern of a patient

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- Number: US 9,750,909 B2
- Document ID: US9750909B2
- Status: Granted
- Kind: B2
- Application number: 14/633,535
- Filed: 2015-02-27
- Published: 2015-06-18
- Granted: 2017-09-05
- Earliest claimed: 2003-08-14
- Assignees: New York University
- Applicants: New York University
- Inventors: David M. Rapoport; Robert G. Norman
- Web page: https://patentgrep.com/patent/US9750909B2

## CPC

- A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation}
- A61B 5/087: Measuring breath flow
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/4812: {Detecting sleep stages or cycles}
- A61B 5/4818: {Sleep apnoea}
- A61M 16/00: Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators (iron lungs A61H31/02); Tracheal tubes
- A61M 16/0003: {Accessories therefor, e.g. sensors, vibrators, negative pressure}
- A61M 16/06: Respiratory or anaesthetic masks
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/0476
- A61B 5/0826: {Detecting or evaluating apnoea events (sleep apnoea A61B5/4818)}
- A61B 5/4809: {Sleep detection, i.e. determining whether a subject is asleep or not}
- A61B 5/7267: {involving training the classification device}
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 2016/003: {with a flowmeter}
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2016/0042: {in the expiratory circuit}
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- Y10S 128/925: Neural network
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

Described is a system including a sensor and a processing arrangement. The sensor measures data corresponding to a patient's breathing patterns. The processing arrangement analyzes the breathing patterns to determine whether the breathing patterns are indicative of a REM sleep state. In another embodiment, the processing arrangement analyzes the breathing patterns to determine whether the breathing patterns are indicative of one of the following states: (i) a wake state and (ii) a sleep state. In another embodiment, a neural network analyzes the data to determine whether the breathing patterns are indicative of one of the following states: (i) a REM sleep state, (ii) a wake state and (iii) a sleep state. In another embodiment, the processing arrangement analyzes the data to determine whether the breathing pattern is indicative of an arousal.

## Claims

### Claim 1

A positive airway pressure system for delivery of a flow of breathable gas at a positive treatment pressure with respect to ambient air pressure delivered to an entrance of a patient's airways in order to assist in treating a sleeping disorder in a patient, the positive airway pressure system comprising:
a flow generator which supplies a positive treatment pressure flow of breathable gases to the entrance of a tube, the tube directing the flow of breathable gases to the airway of a patient to provide the patient with the positive treatment pressure flow of breathable gases;
a flow sensor located in a flow path of the positive treatment pressure flow of breathable gases, the flow sensor measuring data corresponding to the flow of breathable gases directed to the patient and indicative of the patient's breathing patterns; and
a processing arrangement which receives the measured data corresponding to the flow of breathable gases from the flow sensor and analyzes the data to determine the patient's breathing patterns, the processing arrangement also determines whether to alter the pressure supplied to the airway of the patient based, at least in part, on the determined breathing patterns of the patient, wherein the processing arrangement applies a greater positive treatment pressure in an asleep state and a lesser positive treatment pressure in an awake state, wherein when the processor determines that the patient has transitioned between at least an awake state and an asleep state, the processing arrangement automatically controls the flow generator to increase a positive treatment pressure supplied to the entrance of the tube using a ramp system.

### Claim 2 (depends on 1)

The system of claim 1, wherein the processing arrangement determines during an asleep state that the patient is experiencing an elevated upper airway resistance based on the determined patient's breathing patterns and increases the positive treatment pressure supplied to the entrance of the tube.

### Claim 3 (depends on 1)

The system of claim 1, wherein the processing arrangement determines during an asleep state that the patient is experiencing a hypopnea event based on the determined patient's breathing patterns and increases the positive treatment pressure.

### Claim 4 (depends on 1)

The system of claim 1, wherein the processing arrangement determines during an asleep state that the patient is experiencing an apnea event based on the determined patient's breathing patterns and increases the positive treatment pressure.

### Claim 5 (depends on 1)

The system of claim 1, wherein the processing arrangement determines that the patient has transitioned to an awake state from an asleep state based on the determined patient's breathing patterns and lowers the positive treatment pressure.

### Claim 6 (depends on 5)

The system of claim 5, wherein the awake state is a troubled wakefulness state.

### Claim 7 (depends on 1)

The system of claim 1, wherein the processing arrangement determines the patient's state as a function of at least one of a patient's blood pressure, a heart rate and EEG data.

### Claim 8 (depends on 1)

The system of claim 1, further comprising a mask connected to a patient end of the tube and placed on a face of the patient and covering at least one of the mouth and the nose of the patient.

### Claim 9 (depends on 8)

The system of claim 8, further comprising a venting arrangement preventing the patient from rebreathing exhaled airflow.

### Claim 10 (depends on 1)

The system of claim 1, wherein the flow sensor is internal to the flow generator.

### Claim 11 (depends on 1)

The system of claim 1, wherein the flow sensor is external to the flow generator.

### Claim 12 (depends on 1)

The system of claim 1, wherein the processing arrangement determines that the patient is in an asleep state when the breathing pattern is a period of regular breathing indicative of a sleep state.

### Claim 13 (depends on 1)

The system of claim 1, wherein the processing arrangement determines that the patient is in an asleep state when the breathing pattern indicates a pattern of hypopnea event.

### Claim 14 (depends on 1)

The system of claim 1, wherein the processing arrangement determines that the patient is in an asleep state when the breathing pattern indicates a pattern of obstructive apnea events.

### Claim 15 (depends on 14)

The system of claim 14, wherein the pattern of obstructive apnea events is at least three apnea events.

### Claim 16 (depends on 1)

The system of claim 1, wherein when the processing arrangement determines that the patient has transitioned between at least an awake state and an asleep state and is experiencing a hypopnea event, the processing arrangement automatically increases the pressure to a treatment pressure.

### Claim 17 (depends on 1)

The system of claim 1, wherein when the processor determines that the patient has transitioned between at least an awake state and an asleep state and is experiencing an apnea event, the processing arrangement automatically increases the pressure to a treatment pressure.

### Claim 18 (depends on 1)

The system of claim 1, wherein when the processor determines that the patient has transitioned between at least an awake state and an asleep state and is experiencing elevated upper airway resistance, the processing arrangement automatically increases the pressure to at least a first treatment pressure.

### Claim 19

A method for treatment of a sleeping disorder in a patient using a positive airway pressure delivery system that delivers a flow of breathable gases at a positive treatment pressure with respect to ambient air pressure, the flow of breathable gases being delivered to an airway of a patient, the method comprising:
supplying, using a flow generator which generates a flow of gases to produce a positive pressure at or above a pressure at ambient air pressure, a flow of breathable gases to an airway of a patient;
measuring, using a sensor, data indicative of the patient's breathing patterns;
determining, using a processing arrangement, an indication of the patient's breathing patterns based on the data indicative of the patient's breathing patterns;
analyzing, using the processing arrangement, the indication of the patient's breathing patterns to determine the sleep state of a patient;
increasing a pressure of the flow of breathable gases, using the flow generator, to an airway of a patient when the patient is in an asleep state and an elevated upper airway resistance is detected;
applying a lower pressure, using the flow generator, when the processing arrangement determines the patient is in an awake state based on the indication of the patient's breathing patterns; and
ramping an applied pressure to an elevated pressure when the processing arrangement determines that the patient transitions from the awake state to the asleep state based on the indication of the patient's breathing patterns.

### Claim 20 (depends on 19)

The method of claim 19, further comprising increasing a previously provided pressure supplied to a patient when the patient is in an asleep state and a hypopnea is detected.

### Claim 21 (depends on 19)

The method of claim 19, further comprising increasing a previously provided pressure supplied to a patient when the patient is in an asleep state and an apnea event is detected.

### Claim 22 (depends on 19)

The method of claim 19, further comprising increasing a previously provided pressure supplied to a patient when the patient is in an asleep state and an elevated upper airway resistance is detected.

### Claim 23 (depends on 19)

The method of claim 19, wherein applying a lower pressure when the patient is in an awake state comprises applying a lower pressure when the patient is in a troubled wakefulness state.

### Claim 24 (depends on 19)

The method of claim 19, wherein ramping the applied pressure comprises automatically ramping the applied pressure without requiring a manual initiation from a user.

### Claim 25 (depends on 19)

The method of claim 19, wherein ramping the applied pressure comprises a delay in the onset of the applied pressure.

### Claim 26 (depends on 19)

The method of claim 19, wherein an asleep state is determined when regular breathing indicative of a sleep state is detected.

### Claim 27 (depends on 19)

The method of claim 19, wherein an asleep state is determined when a series of hypopnea events are detected.

### Claim 28 (depends on 19)

The method of claim 19, wherein an asleep state is determined when a series of obstructive apnea events are detected.

### Claim 29 (depends on 28)

The method of claim 28, wherein the series of obstructive apnea events is at least three obstructive apnea events.

### Claim 30 (depends on 19)

The method of claim 19, wherein when the processor determines that the patient has transitioned between at least an awake state and an asleep state and is experiencing an apnea event, the processing arrangement automatically increases the pressure to a treatment pressure.

### Claim 31 (depends on 19)

The method of claim 19, wherein when the processor determines that the patient has transitioned between at least an awake state and an asleep state and is experiencing elevated upper airway resistance, the processing arrangement automatically increases the pressure to at least a first treatment pressure.