# US 2018/0021537 A1 · Ergonomic and adjustable respiratory mask assembly with frame

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- Number: US 2018/0021537 A1
- Document ID: US20180021537A1
- Status: Published application
- Kind: A1
- Application number: 15/724,505
- Filed: 2017-10-04
- Published: 2018-01-25
- Earliest claimed: 2002-04-23
- Assignees: ResMed Limited
- Applicants: ResMed Limited
- Inventors: Anthony Michael GING; Saad NASR; Philip Rodney KWOK; Rachael Elizabeth MOORE; Andrew Martin PRICE
- Web page: https://patentgrep.com/patent/US20180021537A1

## CPC

- A61M 16/0683: {Holding devices therefor}
- A61M 16/0057: {Pumps therefor}
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0616: {with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure}
- A61M 16/0622: {having an underlying cushion}
- 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 16/0816: {Joints or connectors}
- A61M 16/0825: {with ball-sockets}
- A61M 16/0875: {Connecting tubes}
- A62B 18/084: {Means for fastening gas-masks to heads or helmets}
- A61M 16/0633: {with forehead support}
- A61M 16/0694: {Chin straps}
- A61M 2016/0661: {with customised shape}
- A61M 2206/14: Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
- A61M 2210/0618: Nose
- 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)}
- A62B: DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING (valves specially adapted for medical use A61M39/00; life-saving devices, apparatus or methods specially adapted for use in water B63C9/00; divers' equipment B63C11/00; specially adopted for use with aircraft, e.g. parachutes, ejector seats, {B64D17/00, B64D25/10}; rescue devices peculiar to mining E21F11/00)

## Abstract

A respiratory mask assembly for delivering breathable gas to a patient includes a frame having a front surface and a rear surface, opposite the front surface, and adapted in use to face the patient. The frame defines an inner wall and an outer wall extending from the rear surface, the inner and outer walls being spaced to define a channel therebetween. A cushion is removably attachable to the frame such that the cushion and frame are repeatably engagable with and disengagable from one another. The cushion includes a side wall to be inserted into the channel of the frame, the side wall having a first interlocking surface that engages a second interlocking surface provided in the channel when the cushion and frame are engaged with one another. The first and second interlocking surfaces interlock with one another to removably attach the cushion to the frame.

## Claims

### Claim 1

(canceled)

### Claim 2

A patient interface assembly for CPAP therapy of a patient, comprising:
a frame with a central aperture;
a cushion supported by the frame;
an elbow adapted to connect to the frame at the central aperture;
a strap assembly including a pair of relatively flexible strap portions constructed of a strap material, and
a pair of stabilizing support members of a relatively rigid material compared to the strap material, each of the stabilizing support members having a degree of flexibility in one direction such that variations in patient physiology can be accommodated in use, wherein each of the pair of stabilizing support members includes a front end that extends away from the frame, each said front end being adapted to extend along the patient's cheeks and below the patient's eye, each said front end branching out into a top end and a bottom end, each said top end being configured to extend along the patient's temple in use and each said bottom end being configured to extend towards a direction inferior to the patient's ear in use, each said top end having an integrally formed connector element in the form of a slot to receive a strap end of a respective one of the pair of strap portions,
wherein the patient interface assembly is not provided with a chin strap, and
wherein the patient interface assembly is not provided with a forehead support.

### Claim 3 (depends on 2)

The patient interface assembly according to claim 2, wherein each said stabilizing support member is stiffer in another direction generally orthogonal to the one direction to resist vertical rotation of the cushion due to the weight of the frame and of components attached to the frame.

### Claim 4 (depends on 2)

The patient interface assembly according to claim 2, wherein the pair of strap portions are made of laminated fabric and foam.

### Claim 5 (depends on 2)

The patient interface assembly according to claim 2, wherein the elbow includes an end portion adapted to be received within the central aperture of the frame.

### Claim 6 (depends on 2)

The patient interface assembly according to claim 2, wherein the elbow includes a gas washout vent with a plurality of holes to allow washout of carbon dioxide.

### Claim 7 (depends on 2)

The patient interface assembly according to claim 2, wherein the elbow is configured to be removed from the frame without accessing an interior portion of the frame.

### Claim 8 (depends on 2)

The patient interface assembly according to claim 2, wherein engagement between the elbow and the frame makes an audible sound.

### Claim 9 (depends on 2)

The patient interface assembly according to claim 2, wherein the elbow includes diametrically opposed sections that are resiliently deformable towards one another to release the elbow.

### Claim 10 (depends on 2)

The patient interface device according to claim 2, wherein the stiffening support structure includes an inside surface to which a soft and flexible material is provided for user comfort.

### Claim 11 (depends on 2)

The patient interface device according to claim 2, wherein the stiffening support structure includes a magnetic connection element.

### Claim 12 (depends on 2)

The patient interface assembly according to claim 2, wherein:
the cushion includes a sealing membrane configured to seal with the patient's nasal bridge region, cheek regions and upper lip region,
each said stabilizing support member is stiffer in another direction generally orthogonal to the one direction to resist vertical rotation of the cushion due to the weight of the frame and of components attached to the frame,
the pair of strap portions are made of laminated fabric and foam,
the elbow includes an end portion adapted to be received within the central aperture of the frame,
the elbow includes a gas washout vent with a plurality of holes to allow washout of carbon dioxide,
the elbow is configured to be removed from the frame without accessing an interior portion of the frame,
engagement between the elbow and the frame makes an audible sound,
the elbow includes diametrically opposed sections that are resiliently deformable towards one another to release the elbow, and
the stiffening support structure includes an inside surface to which a soft and flexible material is provided for user comfort.

### Claim 13 (depends on 2)

A combination, comprising:
the patient interface assembly according to claim 2; and
a plurality of cushions of different sizes.

### Claim 14

A patient interface assembly for therapy of a patient having a breathing disorder, comprising:
a frame with a central aperture by which a flow of pressurized breathable gas is introduced in use;
a cushion supported by the frame;
a strap assembly including a pair of relatively flexible strap portions constructed of a strap material, and
a pair of stabilizing support members of a relatively rigid material compared to the strap material, each of the stabilizing support members having a degree of flexibility in one direction such that variations in patient physiology can be accommodated in use, each said stabilizing support member being stiffer in another direction generally orthogonal to the one direction to resist vertical rotation of the cushion due to the weight of the frame and of components attached to the frame, wherein each of the pair of stabilizing support members includes a front end that extends away from the frame, each said front end being adapted to extend along a curved arc resting against the patient's cheeks and below the patient's eye in use, wherein the strap portions have front ends that are at least partly coextensive with the stabilizing support members to form a layered structure, with the strap members being positioned between the stabilizing support members and the patient's cheeks when worn,
wherein the nasal mask assembly is not provided with a chin strap, and
wherein the nasal mask assembly is not provided with a forehead support.

### Claim 15 (depends on 14)

The patient interface assembly according to claim 14, wherein the cushion comprises nasal pillows.

### Claim 16 (depends on 14)

The patient interface assembly according to claim 14, wherein each said stabilizing support member has a thickness of 0.3-2.0 mm.

### Claim 17 (depends on 16)

The patient interface assembly according to claim 16, wherein the thickness of each said stabilizing support member across its profile varies.

### Claim 18 (depends on 14)

The patient interface assembly according to claim 14, wherein each said stiffening support structure does not extend along the entire length of the respective strap portion.

### Claim 19 (depends on 14)

The patient interface assembly according to claim 14, wherein the frame and the stiffening support structure are connected via a connecting member.

### Claim 20 (depends on 14)

The patient interface assembly according to claim 14, wherein the stiffening support structure and the connecting member form a one piece construction.

### Claim 21 (depends on 14)

The patient interface assembly according to claim 14, wherein the frame, the stiffening support structure and the connecting member form an integral unit.

### Claim 22 (depends on 14)

The patient interface assembly according to claim 14, further comprising a gas washout vent with a plurality of holes to allow washout of carbon dioxide.

### Claim 23 (depends on 14)

The patient interface assembly according to claim 14, wherein the entire strap assembly is connected to the frame solely via the pair of stabilizing support members, forming a two point strap assembly-to-frame connection.

### Claim 24 (depends on 14)

The patient interface assembly according to claim 14, wherein:
the cushion comprises nasal pillows,
each said stabilizing support member has a thickness of 0.3-2.0 mm,
each said stiffening support structure does not extend along the entire length of the respective strap portion,
the frame and the stiffening support structure are connected via a connecting member,
the stiffening support structure and the connecting member form a one piece construction,
the patient interface assembly further comprises a gas washout vent with a plurality of holes to allow washout of carbon dioxide, and
the entire strap assembly is connected to the frame solely via the pair of stabilizing support members, forming a two point strap assembly-to-frame connection.

### Claim 25 (depends on 14)

A combination, comprising:
the patient interface assembly according to claim 14; and
a plurality of cushions of different sizes.

### Claim 26

A patient interface assembly for CPAP therapy of a patient, comprising:
a frame with a central aperture;
a cushion supported by the frame;
an elbow adapted to connect to the frame at the central aperture;
a strap assembly including a pair of relatively flexible strap portions constructed of a strap material, and
a pair of stabilizing support members of a relatively rigid material compared to the strap material, each of the stabilizing support members having a degree of flexibility in one direction such that variations in patient physiology can be accommodated in use, wherein each said stabilizing support member is stiffer in another direction generally orthogonal to the one direction to resist vertical rotation of the cushion due to the weight of the frame and of components attached to the frame, wherein each of the pair of stabilizing support members extends away from the frame, each said stabilizing support member being adapted to extend along a curved arc and rest against the patient's cheeks and below the patient's eye, each said stabilizing support member being configured to curve upwardly along the patient's temple in use, each said stabilizing support member having an integrally formed connector element in the form of a slot to receive a strap end of a respective one of the pair of strap portions,
wherein the patient interface assembly is not provided with a chin strap, and
wherein the patient interface assembly is not provided with a forehead support.

### Claim 27 (depends on 26)

The patient interface assembly according to claim 26, wherein the pair of strap portions are made of laminated fabric and foam.

### Claim 28 (depends on 26)

The patient interface assembly according to claim 26, wherein:
the elbow includes an end portion adapted to be received within the central aperture of the frame,
the elbow includes a gas washout vent with a plurality of holes to allow washout of carbon dioxide,
the elbow is configured to be removed from the frame without accessing an interior portion of the frame,
engagement between the elbow and the frame makes an audible sound, and
the elbow includes diametrically opposed sections that are resiliently movable towards one another to release the elbow.

### Claim 29 (depends on 26)

The patient interface device according to claim 26, wherein the stiffening support structure includes an inside surface to which a soft and flexible material is provided for user comfort.

### Claim 30 (depends on 26)

The patient interface device according to claim 26, wherein the cushion comprises a nose and mouth mask,

### Claim 31 (depends on 26)

The patient interface device according to claim 26, wherein each said stabilizing support member has a thickness of 0.3-2.0 mm.

### Claim 32 (depends on 31)

The patient interface assembly according to claim 31, wherein the thickness of each said stabilizing support member across its profile varies.

### Claim 33 (depends on 26)

The patient interface assembly according to claim 26, wherein the frame and the stiffening support structure are connected via a connecting member.

### Claim 34 (depends on 26)

The patient interface assembly according to claim 26, wherein the stiffening support structure and the connecting member form a one piece construction.

### Claim 35 (depends on 34)

The patient interface assembly according to claim 34, wherein the frame, the stiffening support structure and the connecting member form an integral unit.

### Claim 36 (depends on 26)

The patient interface assembly according to claim 26, wherein:
the pair of strap portions are made of laminated fabric and foam,
the elbow includes an end portion adapted to be received within the central aperture of the frame,
the elbow includes a gas washout vent with a plurality of holes to allow washout of carbon dioxide,
the elbow is configured to be removed from the frame without accessing an interior portion of the frame,
engagement between the elbow and the frame makes an audible sound,
the elbow includes diametrically opposed sections that are resiliently movable towards one another to release the elbow,
the stiffening support structure includes an inside surface to which a soft and flexible material is provided for user comfort,
the cushion comprises a nose and mouth mask,
each said stabilizing support member has a thickness of 0.3-2.0 mm,
the thickness of each said stabilizing support member across its profile varies,
the frame and the stiffening support structure are connected via a connecting member, and
the stiffening support structure and the connecting member form a one piece construction.

### Claim 37 (depends on 26)

A combination, comprising:
the patient interface assembly according to claim 26; and
a plurality of cushions of different sizes.
