# US 2025/0144341 A1 · Patient interface with a seal-forming structure having varying thickness

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- Number: US 2025/0144341 A1
- Document ID: US20250144341A1
- Status: Published application
- Kind: A1
- Application number: 19/012,352
- Filed: 2025-01-07
- Published: 2025-05-08
- Earliest claimed: 2015-09-23
- Assignees: ResMed Pty Ltd
- Applicants: ResMed Pty Ltd
- Inventors: Matthew EVES; Lemmy NGA; Gerard Michael RUMMERY; Rupert Christian SCHEINER
- Web page: https://patentgrep.com/patent/US20250144341A1

## CPC

- A61M 16/0622: {having an underlying cushion}
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0611: {with a gusset portion}
- A61M 16/0616: {with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure}
- A61M 16/0633: {with forehead support}
- 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 16/0683: {Holding devices therefor}
- A61M 16/0825: {with ball-sockets}
- A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation}
- A61M 16/0875: {Connecting tubes}
- A61M 16/1055: {bacterial}
- A61M 16/107: {in the inspiratory path}
- A61M 16/109: {the humidifying liquid or the beneficial agent}
- A61M 16/1095: {in the connecting tubes}
- A61M 16/16: Devices to humidify the respiration air {(A61M16/1045 takes precedence)}
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2205/42: Reducing noise
- A61M 2207/00: Methods of manufacture, assembly or production
- 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 cushion assembly for a patient interface including an elastomeric seal-forming structure that is shaped to be bisected by a sagittal plane having a line that is tangent to the elastomeric seal-forming structure at a superior tangent point and at an inferior tangent point. A saddle-shaped superior region of the elastomeric seal-forming structure straddles the sagittal plane and includes the superior tangent point. The elastomeric seal-forming structure transitions in a cylinder-shaped superior region from the saddle-shaped region to a dome-shaped superior region offset from the sagittal plane. In addition, an elastomeric wall thickness of the elastomeric seal-forming structure is greater in the cylinder-shaped superior region than in the saddle-shaped superior region and the dome-shaped superior region.

## Claims

### Claim 1

A cushion assembly for a patient interface for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to a patient's airways including at least entrance of the patient's nares, wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use, throughout the patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing, the cushion assembly comprising:
an elastomeric support portion;
an elastomeric seal-forming structure supported by the elastomeric support portion and being shaped to be bisected by a sagittal plane that includes a line tangent to the elastomeric seal-forming structure at a superior tangent point and at an inferior tangent point, the elastomeric support portion being more rigid than the elastomeric seal-forming structure and comprising a first compliant region that includes the superior tangent point and a second compliant region separated from the first compliant region by a support region that is more rigid than the first and second compliant regions;
a blowout prevention system comprising a first end that is anchored to the elastomeric support portion and a second end that is a continuation of the elastomeric seal-forming structure at the second compliant region; and
a chamber defined by the elastomeric support portion and the elastomeric seal-forming structure,
wherein the elastomeric seal-forming structure comprises an inner surface forming a boundary for the chamber and comprises an outer surface opposite the inner surface,
wherein a second end of the blowout prevention system is a continuation of the elastomeric seal-forming structure at the second compliant region, and
wherein the more rigid support region extends to and is anchored by the elastomeric support portion, and wherein an elastomeric wall thickness in the more rigid support region is invariable.

### Claim 2 (depends on 1)

The cushion assembly of claim 1, wherein an elastomeric wall thickness of the elastomeric seal-forming structure in the first compliant region is the same as an elastomeric wall thickness of the elastomeric seal-forming structure in the second compliant region.

### Claim 3 (depends on 1)

The cushion assembly of claim 1, wherein the first compliant region of the elastomeric seal-forming structure extends to the elastomeric support portion, and the second compliant region of the elastomeric seal-forming structure does not extend to the elastomeric support portion.

### Claim 4 (depends on 1)

The cushion assembly of claim 1, wherein the blowout prevention system is in the form of a tubular structure.

### Claim 5 (depends on 1)

The cushion assembly of claim 1, wherein the more rigid support region is positioned at a location that is superior to the blowout prevention system.

### Claim 6 (depends on 1)

The cushion assembly of claim 1, wherein the elastomeric seal-forming structure further comprises an inferior region that includes the inferior tangent point, and wherein the elastomeric wall thickness of the elastomeric seal-forming structure in the inferior region is the same as the elastomeric wall thickness in the first compliant region.

### Claim 7 (depends on 6)

The cushion assembly of claim 6, wherein the elastomeric seal-forming structure further comprises a first intermediate region that extends from the second compliant region to the inferior region, and wherein the elastomeric wall thickness of the elastomeric seal-forming structure is thicker in the first intermediate region than in the second compliant region.

### Claim 8 (depends on 7)

The cushion assembly of claim 7, wherein the elastomeric seal-forming structure further comprises a second intermediate region adjacent the first intermediate region, and wherein the elastomeric wall thickness of the elastomeric seal-forming structure is thicker in the second intermediate region than in the first intermediate region.

### Claim 9 (depends on 8)

The cushion assembly of claim 8, wherein the first intermediate region intervenes between the inferior region and the second intermediate region.

### Claim 10 (depends on 8)

The cushion assembly of claim 8, wherein the second intermediate region is positioned between the elastomeric support portion and the first intermediate region.

### Claim 11 (depends on 1)

The cushion assembly of claim 1, wherein an elastomeric wall thickness of the elastomeric seal-forming structure in the first compliant region is the same as an elastomeric wall thickness of the elastomeric seal-forming structure in the second compliant region,
wherein the first compliant region of the elastomeric seal-forming structure extends to the elastomeric support portion, and the second compliant region of the elastomeric seal-forming structure does not extend to the elastomeric support portion,
wherein the blowout prevention system is in the form of a tubular structure,
wherein the more rigid support region is positioned at a location that is superior to the blowout prevention system,
wherein the elastomeric seal-forming structure further comprises an inferior region that includes the inferior tangent point, and wherein the elastomeric wall thickness of the elastomeric seal-forming structure in the inferior region is the same as the elastomeric wall thickness in the first compliant region,
wherein the elastomeric seal-forming structure further comprises a first intermediate region that extends from the second compliant region to the inferior region, and wherein the elastomeric wall thickness of the elastomeric seal-forming structure is thicker in the first intermediate region than in the second compliant region,
wherein the elastomeric seal-forming structure further comprises a second intermediate region adjacent the first intermediate region, and wherein the elastomeric wall thickness of the elastomeric seal-forming structure is thicker in the second intermediate region than in the first intermediate region,
wherein the first intermediate region intervenes between the inferior region and the second intermediate region, and
wherein the second intermediate region is positioned between the elastomeric support portion and the first intermediate region.

### Claim 12 (depends on 1)

A patient interface comprising:
the cushion assembly of claim 1;
a rigid shell removably connected to the cushion assembly; and
headgear removably attached to the rigid shell.

### Claim 13 (depends on 12)

A CPAP system comprising:
the patient interface according to claim 12;
a flow generator configured to pressurize a flow of gas; and
an air delivery tube configured to deliver the pressurized gas to the patient interface.

### Claim 14

A cushion assembly for a patient interface for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to a patient's airways including at least entrance of the patient's nares, wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use, throughout the patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing, the cushion assembly comprising:
an elastomeric support portion;
an elastomeric seal-forming structure supported by the elastomeric support portion and being shaped to be bisected by a sagittal plane that includes a line tangent to the elastomeric seal-forming structure at a superior tangent point and at an inferior tangent point, the elastomeric support portion being more rigid than the elastomeric seal-forming structure; and
a chamber defined by the elastomeric support portion and the elastomeric seal-forming structure,
wherein the elastomeric seal-forming structure comprises an inner surface forming a boundary for the chamber and comprises an outer surface opposite the inner surface,
wherein the elastomeric seal-forming structure comprises a first compliant region that includes the superior tangent point and a second compliant region separated from the first compliant region by a support region that is more rigid than the first and second compliant regions,
wherein the more rigid support region extends to and is anchored by the elastomeric support portion, and wherein for every point in the rigid support region, a curvature of the inner surface follows a curvature of the outer surface,
wherein the outer surface of the elastomeric seal-forming structure in the first compliant region is saddle-shaped, wherein at least a portion of the outer surface of the elastomeric seal-forming structure in the second compliant region is dome-shaped, and wherein in the more rigid support region, the outer surface of the elastomeric seal-forming structure transitions from the saddle shape of the first compliant region to the dome shape in the second compliant region.

### Claim 15 (depends on 14)

The cushion assembly of claim 14, wherein the elastomeric seal-forming structure comprises an inferior region that includes the inferior tangent point, and wherein the outer surface of the elastomeric seal-forming structure in the inferior region is saddle-shaped.

### Claim 16 (depends on 15)

The cushion assembly of claim 15, wherein the elastomeric seal-forming structure comprises an intermediate region between the inferior region and the second compliant region, and wherein at least a portion of the outer surface of the elastomeric seal-forming structure in the intermediate region is cylinder shaped.

### Claim 17 (depends on 16)

The cushion assembly of claim 16, wherein the outer surface of the elastomeric seal-forming structure is dome-shaped in a portion of the intermediate region that is adjacent the inferior region.

### Claim 18 (depends on 17)

The cushion assembly of claim 17, wherein the dome-shaped portion of the intermediate region has a larger radius of curvature than the radius of curvature of the dome shape in the second compliant region.

### Claim 19 (depends on 14)

The cushion assembly of claim 14, further comprising a blowout prevention system with a first end anchored to the elastomeric support portion and a second end that is a continuation of a portion of the elastomeric seal-forming structure at which the outer surface is cylinder-shaped.

### Claim 20 (depends on 19)

The cushion assembly of claim 19, wherein the blowout prevention system is in the form of a tubular structure.
