# US 11,433,213 B2 · Treatment of respiratory conditions

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- Number: US 11,433,213 B2
- Document ID: US11433213B2
- Status: Granted
- Kind: B2
- Application number: 17/156,021
- Filed: 2021-01-22
- Published: 2021-05-13
- Granted: 2022-09-06
- Earliest claimed: 2008-06-05
- Assignees: ResMed Pty Ltd
- Applicants: ResMed Pty Ltd
- Inventors: Peter John Sweeney; Adam Vivian Benjafield; Steven Paul Farrugia; Dieter Heidmann; Glenn Richards; Paul Jan Klasek
- Web page: https://patentgrep.com/patent/US11433213B2

## CPC

- A61M 16/16: Devices to humidify the respiration air {(A61M16/1045 takes precedence)}
- A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/0688: {by means of an adhesive}
- A61M 16/1095: {in the connecting tubes}
- A61M 16/161: {with means for measuring the humidity}
- A61M 16/204: {used for inhalation control}
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 16/0666: {Nasal cannulas or tubing (devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02)}
- A61M 16/0825: {with ball-sockets}
- A61M 16/107: {in the inspiratory path}
- 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 2202/0208: Oxygen
- A61M 2205/15: Detection of leaks
- A61M 2205/18: with alarm
- A61M 2205/3368: Temperature
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/8206: battery-operated
- A61M 2205/8237: Charging means
- 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

A device (102) provides respiratory treatment for SDB (including mild OSA) and other respiratory conditions. A flow generator warms and humidifies gas at controlled flow levels. For example, the device (102) delivers breathable gas to the upper airway at flow rates of about 10-35 Liters/minute. Levels of flow rate, temperature and/or humidification of the device may be automatically adjusted in response to the detection of SDB events. The device may also automatically deliver adjustments of any of the levels in accordance with detected phases of respiratory cycles. In some embodiments, the device automatically delivers distinct levels to either of the nares based on independent control of flow to each nare. A warm-up procedure controls temperature and humidity at a desired target during a ramp-up of flow in the set therapy level. A cool-down procedure controls temperature above the dewpoint to avoid condensation internal to the device and patient interface.

## Claims

### Claim 1

A nasal mask assembly for providing high flow respiratory therapy to a patient, the nasal mask assembly comprising:
a nasal interface configured to deliver a flow of pressurized breathable gas to the patient, the nasal interface comprising:
a pair of nasal inserts to be inserted into the nares of the patient without sealing against the nares;
an inlet through which the pressurized breathable gas is received;
a nasal interface body with one or more surfaces defining one or more fluid passageways from the inlet to the pair of nasal inserts;
a left lateral headgear connector extending from a left lateral side of the nasal interface, the left lateral headgear connector including a left protrusion at an end of the left lateral headgear connector; and
a right lateral headgear connector extending from a right lateral side of the nasal interface, the right lateral headgear connector including a right protrusion at an end of the right lateral headgear connector,
wherein:
the nasal interface body includes a first barrel portion and a second barrel portion,
the first barrel portion is provided on a frame that includes the left lateral headgear connector, the right lateral headgear connector, and the pair of nasal inserts, and
the second barrel portion includes the inlet and an upper aperture configured to sealingly connect to the first barrel portion,
the first barrel portion includes an upper surface and a mounting boss extending downward from a medial portion of the upper surface and connecting to the frame at a position below the upper surface,
the mounting boss, the upper surface, and the frame of the first barrel portion define a loop having a first loop opening and a second loop opening, and
the second barrel portion is configured to be inserted into the first barrel portion and to completely fill the first loop opening and the second loop opening to sealingly connect the upper aperture to the first barrel portion;
a conduit to provide the flow of pressurized breathable gas to the nasal interface, the conduit including a first end and a second end, the first end being connected to a supply of pressurized breathable gas and the second end being connected to the inlet of the nasal interface;
a headgear assembly to position the nasal interface below the patient's nares, the headgear assembly comprising a plurality of headgear straps that include at least:
a left headgear strap with a left connecting end that is configured to connect to the left lateral headgear connector, wherein the left connecting end defines a left aperture that is configured to receive and retain the left protrusion when the left protrusion is inserted into the left aperture; and
a right headgear strap with a right connecting end that is configured to connect to the right lateral headgear connector, wherein the right connecting end defines a right aperture that is configured to receive and retain the right protrusion when the right protrusion is inserted into the right aperture.

### Claim 2 (depends on 1)

The nasal mask assembly of claim 1, wherein:
the left lateral headgear connector includes (i) a first left segment that extends laterally from the nasal interface generally along a lateral plane and (ii) a second left segment that extends from the first left segment generally along an upward left plane to the end of the left lateral headgear connector, the upward left plane being at a upward left angle relative to the lateral plane,
the right lateral headgear connector includes (i) a first right segment that extends laterally from the nasal interface generally along the lateral plane and (ii) a second right segment that extends from the first right segment generally along an upward right plane to the end of the right lateral headgear connector, the upward right plane being at a upward right angle relative to the lateral plane.

### Claim 3 (depends on 2)

The nasal mask assembly of claim 2, wherein the upward left angle and the upward right angle are obtuse angles.

### Claim 4 (depends on 3)

The nasal mask assembly of claim 3, wherein the upward left angle is a mirror angle of the upward right angle reflected over a medial plane of the nasal interface.

### Claim 5 (depends on 4)

The nasal mask assembly of claim 4, wherein:
the first left segment and the first right segment are configured to extend along and contact an upper lip of the patient,
the second left segment is configured to extend along and contact a left cheek of the patient, and
the second right segment is configured to extend along and contact a right cheek of the patient.

### Claim 6 (depends on 5)

The nasal mask assembly of claim 5, wherein:
the left lateral headgear connector is configured so that, when the nasal assembly is positioned on the patient to provide respiratory therapy, (i) the upward left plane of the second left segment extends above the patient's left ear and (ii) the end of the left lateral headgear connector is positioned on the patient's left cheek, and
the right lateral headgear connector is configured so that, when the nasal assembly is positioned on the patient to provide respiratory therapy, (i) the upward right plane of the second right segment extends above the patient's right ear and (ii) the end of the right lateral headgear connector is positioned on the patient's right cheek.

### Claim 7 (depends on 6)

The nasal mask assembly of claim 6, wherein:
the left headgear strap is configured to extend along the patient's left cheek, above the patient's left ear, and to a back of the patient's head, and
wherein the right headgear strap is configured to extend along the patient's right cheek, above the patient's right ear, and to the back of the patient's head.

### Claim 8 (depends on 7)

The nasal mask assembly of claim 7, wherein the plurality of headgear straps further include:
a rear upper strap connected to the left headgear strap and the right headgear strap, the rear upper strap being configured to extend along the back of the patient's head between the left headgear strap and the right headgear strap, and
a rear lower strap connected to the left headgear strap and the right headgear strap, the rear lower strap being configured to extend along the back of the patient's head below the rear upper strap and between the left headgear strap and the right headgear strap.

### Claim 9 (depends on 8)

The nasal mask assembly of claim 8, wherein:
the rear upper strap and the rear lower strap are connected to the left headgear strap at a common left junction point, and
the rear upper strap and the rear lower strap are connected to the right headgear strap at a common right junction point.

### Claim 10 (depends on 9)

The nasal mask assembly of claim 9, wherein, when the nasal assembly is positioned on the patient to provide respiratory therapy, the common left junction point and the common right junction point are positioned above an axial plane at a top of the patient's ears.

### Claim 11 (depends on 10)

The nasal mask assembly of claim 10, wherein, when the nasal assembly is positioned on the patient to provide respiratory therapy, the common left junction point and the common right junction point are positioned along a coronal plane that intersects the patient's ears.

### Claim 12 (depends on 9)

The nasal mask assembly of claim 9, wherein the left headgear strap, the right headgear strap, the rear upper strap, and the rear lower strap are integrally formed of a material.

### Claim 13 (depends on 11)

The nasal mask assembly of claim 11, wherein:
the left lateral headgear connector and the right lateral headgear connector are made of a silicon material, and
the material in which the left headgear strap, the right headgear strap, the rear upper strap, and the rear lower strap are integrally formed comprises a fabric material.

### Claim 14 (depends on 1)

The nasal mask assembly of claim 1, wherein the inlet is positioned on a lateral side of the nasal interface body such that, when connected, the conduit extends from the lateral side of the nasal interface.

### Claim 15 (depends on 14)

The nasal mask assembly of claim 14, wherein the inlet is positioned on left lateral side of the nasal interface body.

### Claim 16 (depends on 14)

The nasal mask assembly of claim 14, wherein the inlet is positioned on right lateral side of the nasal interface body.

### Claim 17 (depends on 1)

The nasal mask assembly of claim 1, wherein the second barrel portion is configured to sealingly connect to, at least, the upper surface of the first barrel portion when the second barrel portion is inserted into and at least partially through the loop defined, in part, by the mounting boss.

### Claim 18 (depends on 17)

The nasal mask assembly of claim 17, wherein the second barrel portion is configured to be laterally inserted into and at least partially through the loop, and for the inlet to extend from a lateral side of the nasal interface body.

### Claim 19 (depends on 17)

The nasal mask assembly of claim 17, wherein the second barrel portion comprises a tube defined at one end by the inlet and the other end by an angled wall that directs air into the upper aperture, wherein the upper aperture is defined in a side of the tube.

### Claim 20 (depends on 1)

The nasal mask assembly of claim 1, wherein the pair of nasal inserts extend from the nasal interface body and have a concave curvature along their length toward the patient's nares.

### Claim 21 (depends on 1)

The nasal mask assembly of claim 1, wherein the upper surface is wider t its connection to the frame than the mounting boss.

### Claim 22 (depends on 1)

The nasal mask assembly of claim 1, further comprising means for generating the supply of pressurized breathable gas.