# US 10,369,310 B2 · Method and apparatus for treatment of respiratory disorders

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- Number: US 10,369,310 B2
- Document ID: US10369310B2
- Status: Granted
- Kind: B2
- Application number: 14/197,745
- Filed: 2014-03-05
- Published: 2015-09-10
- Granted: 2019-08-06
- Earliest claimed: 2014-03-05
- Assignees: ResMed Pty Ltd
- Applicants: ResMed Limited
- Inventors: Dinesh Ramanan; Jeffrey Peter Armitstead; Joon-Pil Hwang; Jane Zona Mchenry; Nathan John Row
- Web page: https://patentgrep.com/patent/US10369310B2

## CPC

- A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation}
- A61M 16/0003: {Accessories therefor, e.g. sensors, vibrators, negative pressure}
- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0683: {Holding devices therefor}
- A61M 16/107: {in the inspiratory path}
- A61M 16/1075: {by influencing the temperature (A61M16/1045 takes precedence)}
- A61M 16/16: Devices to humidify the respiration air {(A61M16/1045 takes precedence)}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0036: {in the breathing tube and used in both inspiratory and expiratory phase}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2202/0208: Oxygen
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3365: Rotational speed
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2230/40: Respiratory characteristics
- A61M 2230/432: partial CO2 pressure (P-CO2)
- A61M 2230/435: partial O2 pressure (P-O2)
- A61M 2230/63: Motion, e.g. physical activity
- 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)}

## Abstract

Disclosed is an apparatus for treating a respiratory disorder. The apparatus comprises a pressure device, and a controller, including at least one processor, configured to control the pressure device to: supply, upon initiation of treatment, a flow of pressurized air to the airway of a patient at a treatment pressure according to a pre-sleep profile of pressure versus time, increase, upon detection of sleep onset of the patient, the treatment pressure to a predetermined therapeutic pressure according to a bridging profile of pressure versus time, and supply the flow of pressurized air to the airway of the patient at a therapeutic pressure.

## Claims

### Claim 1

Apparatus for treating a respiratory disorder comprising:
a pressure device, and
a controller, including at least one processor, configured to control the pressure device to:
supply, upon initiation of treatment, a flow of pressurised air to the airway of a patient at a treatment pressure according to a pre-sleep profile of pressure versus time,
increase, upon detection of sleep onset of the patient, the treatment pressure to a predetermined therapeutic pressure according to a bridging profile of pressure versus time, and
supply the flow of pressurised air to the airway of the patient at a therapeutic pressure,
wherein the controller is configured to detect the sleep onset by detecting:
few or no respiratory disturbances occurring within a predetermined interval, the predetermined interval being a predetermined time or predetermined breath count, wherein, by monitoring respiratory flow derived from a flow transducer, the controller detects few or no respiratory disturbances to detect the sleep onset by testing lack of variation during the predetermined interval of expiratory peak flow location.

### Claim 2 (depends on 1)

Apparatus according to claim 1 wherein the pre-sleep profile is determined by the processor according to a pre-sleep time parameter, and wherein the bridging profile is determined by the processor according to a bridging time parameter, and wherein the bridging time parameter is substantially shorter than the pre-sleep time parameter.

### Claim 3 (depends on 2)

Apparatus according to claim 2, wherein the pre-sleep profile is a constant value equal to a pre-sleep pressure for a duration equal to the pre-sleep time parameter, and wherein the controller is configured to make the detection of the sleep onset during application of the constant value of the pre-sleep profile.

### Claim 4 (depends on 2)

Apparatus according to claim 2, wherein the pre-sleep profile is a linear increase, with slope chosen such that the pressure would reach the predetermined therapeutic pressure at the pre-sleep time parameter in the absence of sleep onset detection.

### Claim 5 (depends on 2)

Apparatus according to claim 2, wherein the pre-sleep profile is a series of linear increases separated by pause periods during which the pressure is constant, wherein a slope and duration of the linear increases and a pause period duration are chosen such that the pressure would reach the predetermined therapeutic pressure at the pre-sleep time parameter in the absence of sleep onset detection.

### Claim 6 (depends on 2)

Apparatus according to claim 2, wherein the bridging profile is a linear increase, with slope chosen such that the pressure reaches the predetermined therapeutic pressure at the bridging time parameter.

### Claim 7 (depends on 2)

Apparatus according to claim 2, wherein the bridging profile is a series of linear increases separated by pause periods during which the pressure is constant, wherein the slope and duration of the linear increases and the pause period duration are chosen such that the pressure reaches the predetermined therapeutic pressure at the bridging time parameter.

### Claim 8 (depends on 1)

Apparatus according to claim 1, wherein the pre-sleep profile is determined by the processor according to a pre-sleep slope, the bridging profile is determined by the processor according to a bridging slope, and wherein the bridging slope is substantially higher than the pre-sleep slope.

### Claim 9 (depends on 8)

Apparatus according to claim 8, wherein the pre-sleep profile is a constant value equal to a pre-sleep pressure.

### Claim 10 (depends on 8)

Apparatus according to claim 8, wherein the pre-sleep profile is a linear increase of slope equal to the pre-sleep slope.

### Claim 11 (depends on 8)

Apparatus according to claim 8, wherein the pre-sleep profile is a series of linear increases separated by pause periods during which the pressure is constant, wherein the slope of the linear increases is equal to the pre-sleep slope.

### Claim 12 (depends on 8)

Apparatus according to claim 8, wherein the pre-sleep profile is a series of linear increases that coincide with inspiratory portions of each breathing cycle, separated by pause periods that coincide with expiratory portions of each breathing cycle during which the pressure is held constant, wherein the slope of the linear increases is equal to the pre-sleep slope.

### Claim 13 (depends on 8)

Apparatus according to claim 8, wherein the bridging profile is a linear increase, of slope equal to the bridging slope.

### Claim 14 (depends on 8)

Apparatus according to claim 8, wherein the bridging profile is a series of linear increases separated by pause periods during which the pressure is constant, wherein the slope of the linear increases is equal to the bridging slope.

### Claim 15 (depends on 8)

Apparatus according claim 8, wherein the bridging profile is a series of linear increases that coincide with inspiratory portions of each breathing cycle, separated by pause periods that coincide with expiratory portions of each breathing cycle during which the pressure is held constant, wherein the slope of the linear increases is equal to the bridging slope.

### Claim 16 (depends on 1)

Apparatus according to claim 1, wherein the controller is further configured to control the pressure device to increase the treatment pressure to the predetermined therapeutic pressure according to the bridging profile upon expiry of a predetermined timer limit.

### Claim 17 (depends on 1)

Apparatus according to claim 1, wherein the therapeutic pressure is the predetermined therapeutic pressure.

### Claim 18 (depends on 1)

Apparatus according to claim 1, wherein the therapeutic pressure varies according to occurrences of sleep disordered breathing events.

### Claim 19

A method of treating a respiratory disorder, the method comprising:
supplying, upon initiation of treatment, a flow of pressurised air from a pressure device to the airway of a patient at a treatment pressure according to a pre-sleep profile of pressure versus time,
increasing, upon detection of sleep onset of the patient by a controller of the pressure device, the treatment pressure to a predetermined therapeutic pressure according to a bridging profile of pressure versus time, and
supplying the flow of pressurised air to the airway of the patient at a therapeutic pressure,
wherein the controller of the pressure device is configured to detect the sleep onset by detecting:
few or no respiratory disturbances occurring within a predetermined interval, the predetermined interval being a predetermined time or predetermined breath count, wherein, by monitoring respiratory flow derived from a flow transducer, the controller detects few or no respiratory disturbances to detect the sleep onset by testing lack of variation during the predetermined interval of expiratory peak flow location.

### Claim 20

Apparatus for treating a respiratory disorder comprising:
a pressure device, and
a controller, including at least one processor, configured to control the pressure device to:
supply, upon initiation of treatment, a flow of pressurised air to the airway of a patient at a treatment pressure that commences at a pre-sleep pressure and varies according to occurrences of sleep disordered breathing events,
increase, upon detection of sleep onset of the patient, the treatment pressure to a predetermined therapeutic pressure according to a bridging profile of pressure versus time, and
supply the flow of pressurised air to the airway of the patient at a therapeutic pressure,
wherein the controller is configured to detect the sleep onset by detecting:
few or no respiratory disturbances occurring within a predetermined interval, the predetermined interval being a predetermined time or predetermined breath count, wherein, by monitoring respiratory flow derived from a flow transducer, the controller detects few or no respiratory disturbances to detect the sleep onset by testing lack of variation during the predetermined interval of expiratory peak flow location.

### Claim 21 (depends on 20)

Apparatus according to claim 20, wherein the controller is further configured to control the pressure device to increase the treatment pressure to the predetermined therapeutic pressure according to the bridging profile upon expiry of a predetermined timer limit.

### Claim 22 (depends on 20)

Apparatus according to claim 20, wherein the controller is further configured to control the pressure device to increase the treatment pressure to the predetermined therapeutic pressure according to the bridging profile upon the treatment pressure reaching the predetermined therapeutic pressure.

### Claim 23 (depends on 20)

Apparatus according to claim 20, wherein the treatment pressure varies according to occurrences of sleep disordered breathing events such that the treatment pressure is prevented from decreasing.

### Claim 24 (depends on 20)

Apparatus according to claim 20, wherein the treatment pressure varies according to occurrences of sleep disordered breathing events between a predetermined pre-sleep pressure and the predetermined therapeutic pressure.

### Claim 25

A method of treating a respiratory disorder, the method comprising:
supplying, upon initiation of treatment, a flow of pressurised air from a pressure device to the airway of a patient at a treatment pressure that commences at a pre-sleep pressure and varies according to occurrences of sleep disordered breathing events,
increasing, upon detection of sleep onset of the patient by a controller of the pressure device, the treatment pressure to a predetermined therapeutic pressure according to a bridging profile of pressure versus time, and
supplying the flow of pressurised air to the airway of the patient at a therapeutic pressure,
wherein the controller of the pressure device to provide the increasing treatment pressure is configured to detect the sleep onset by detecting:
few or no respiratory disturbances occurring within a predetermined interval, the predetermined interval being a predetermined time or predetermined breath count, wherein, by monitoring respiratory flow derived from a flow transducer, the controller detects few or no respiratory disturbances to detect the sleep onset by testing lack of variation during the predetermined interval of expiratory peak flow location.

### Claim 26

Apparatus for treating a respiratory disorder comprising:
a pressure device, and
a controller, including at least one processor, configured to control the pressure device to:
supply, upon initiation of treatment, a flow of pressurised air to the airway of a patient at a treatment pressure according to a pre-sleep profile of pressure versus time,
adjust, upon detection of sleep onset of the patient, the treatment pressure according to occurrences of sleep disordered breathing events, and
supply, upon the treatment pressure reaching a predetermined therapeutic pressure, the flow of pressurised air to the airway of the patient at a therapeutic pressure,
wherein the processor is configured to detect the sleep onset by detecting:
few or no respiratory disturbances enduring for a predetermined interval, the predetermined interval being a predetermined time or predetermined breath count, wherein, by monitoring respiratory flow derived from a flow transducer, the processor detects few or no respiratory disturbances to detect the sleep onset by testing lack of variation during the predetermined interval of expiratory peak flow location.

### Claim 27 (depends on 26)

Apparatus according to claim 26, wherein the controller is further configured to control the pressure device to supply the flow of pressurised air to the airway of the patient at the therapeutic pressure upon expiry of a predetermined timer limit.

### Claim 28 (depends on 26)

Apparatus according to claim 26, wherein the controller is configured to control the pressure device to adjust the treatment pressure according to occurrences of sleep disordered breathing events such that the treatment pressure is prevented from decreasing.

### Claim 29 (depends on 26)

Apparatus according to claim 26, wherein the controller is configured to control the pressure device to adjust the treatment pressure according to occurrences of sleep disordered breathing events below the predetermined therapeutic pressure.

### Claim 30

A method of treating a respiratory disorder, the method comprising:
supplying, upon initiation of treatment, a flow of pressurised air from a pressure device to the airway of a patient at a treatment pressure according to a pre-sleep profile of pressure versus time,
adjusting, upon detection of sleep onset of the patient by a controller of the pressure device, the treatment pressure according to occurrences of sleep disordered breathing events, and
supplying, upon the treatment pressure reaching a predetermined therapeutic pressure, the flow of pressurised air to the airway of the patient at a therapeutic pressure,
wherein the controller of the pressure device to provide the treatment pressure detects the sleep onset by detecting:
few or no respiratory disturbances occurring within a predetermined interval, the predetermined interval being a predetermined time or predetermined breath count, wherein, by monitoring respiratory flow derived from a flow transducer, the controller detects few or no respiratory disturbances to detect the sleep onset by testing lack of variation during the predetermined interval of expiratory peak flow location.

### Claim 31 (depends on 1)

The apparatus of claim 1 wherein the controller is further configured to detect sleep onset by detecting multiple occurrences of sleep disordered breathing events within a second predetermined interval, the second predetermined interval being a second predetermined time or second predetermined breath count.

### Claim 32 (depends on 1)

The apparatus of claim 1 wherein the controller detects few or no respiratory disturbances by testing lack of variation during the predetermined interval of one or more of (a) tidal volume, (b) inspiratory time, (c) respiratory rate, (d) inspiratory peak flow, and (e) time since last breath.

### Claim 33 (depends on 32)

The apparatus of claim 32 wherein the predetermined interval is the predetermined time and the predetermined time is in a range of two to nine minutes.

### Claim 34 (depends on 32)

The apparatus of claim 32 wherein the predetermined interval is the predetermined breath count and the predetermined breath count is in a range of ten to fifty breaths.
