# US 12,599,739 B2 · Patient interface with foam cushion

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- Number: US 12,599,739 B2
- Document ID: US12599739B2
- Status: Granted
- Kind: B2
- Application number: 17/787,710
- Filed: 2019-12-20
- Published: 2023-02-09
- Granted: 2026-04-14
- Earliest claimed: 2019-12-20
- Assignees: ResMed Asia Pte. Ltd.
- Applicants: Resmed Asia Pte. Ltd.
- Inventors: Robin Yew; Lik Tze Seet; Andrew James Bate; Kam Man Law
- Web page: https://patentgrep.com/patent/US12599739B2

## CPC

- A61M 16/0622: {having an underlying cushion}
- A61M 16/0672: {Nasal cannula assemblies for oxygen therapy}
- A61M 16/0683: {Holding devices therefor}
- A61M 16/0816: {Joints or connectors}
- A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation}
- A61M 16/1005: {with O2 features or with parameter measurement}
- 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 16/161: {with means for measuring the humidity}
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3368: Temperature
- 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 2205/502: User interfaces, e.g. screens or keyboards
- 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)}

## Abstract

A patient interface is configured to deliver a flow of positive pressure respiratory gas to an entrance of a patients airways. The patient interface includes an elastomeric support wall forming at least part of a plenum chamber configured to receive the flow of positive pressure respiratory gas. The patient interface also includes an elastomeric support flange positioned at an end of the elastomeric support wall and extending radially inward from the support wall. The support flange has a flap portion at a central superior region of the support flange that extends further in the radially inward direction than the rest of the support flange. In addition, a foam cushion is mounted on the support flange. The foam cushion is configured to form a seal with the patients face and includes an attachment surface that is in contact with an outer surface of the support flange.

## Claims

### Claim 1

A patient interface configured to deliver a flow of positive pressure respiratory gas to an entrance of a patient's airways including at least an entrance of the patient's nares, the patient interface being configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient pressure in use, throughout the patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing, the patient interface comprising:
an elastomeric support wall forming at least part of a plenum chamber configured to receive the flow of positive pressure respiratory gas, the elastomeric support wall comprising a pair of thickened regions on opposing sides of a plane that bisects the elastomeric support wall and extends from the superior side of the elastomeric support wall to the inferior side of the elastomeric support wall;
an elastomeric support flange positioned at an end of the elastomeric support wall and extending radially inward from the support wall, the support flange comprising a flap portion at a central superior region of the support flange that extends further in the radially inward direction than the rest of the support flange; and
a foam cushion mounted on the support flange, the foam cushion being configured to form a seal with the patient's face and comprising an attachment surface that is in contact with an outer surface of the support flange,
wherein the thickness of the elastomeric support wall is greatest in the pair of thickened regions, and
wherein the increased thickness of the thickened regions of the elastomeric support wall does not extend into the elastomeric support flange.

### Claim 2 (depends on 1)

The patient interface of claim 1, wherein the attachment surface of the foam cushion is widest at a location corresponding to the flap portion.

### Claim 3 (depends on 1)

The patient interface of according to claim 1, wherein the outer surface of the support flange at the flap portion has a positive curvature.

### Claim 4 (depends on 3)

The patient interface of claim 3, wherein a central inferior region of the support flange has a positive curvature.

### Claim 5 (depends on 4)

The patient interface of claim 4, wherein the curvature of the support flange in the flap portion is larger than the curvature of the support flange in the central inferior region.

### Claim 6 (depends on 1)

The patient interface of claim 1, wherein the central inferior region of the support flange is between a first pair of negative curvature regions of the support flange.

### Claim 7 (depends on 1)

The patient interface of claim 1, wherein the flap portion is between a second pair of negative curvature regions of the support flange.

### Claim 8 (depends on 1)

The patient interface of claim 1, wherein the support flange comprises eight transition regions in which the curvature of the outer surface of the support flange transitions from positive to negative or negative to positive.

### Claim 9 (depends on 1)

The patient interface of claim 1, wherein the foam cushion comprises a sealing surface configured to be in contact with the patient's face in use, wherein the sealing surface of the foam cushion has a positive curvature at locations where the outer surface of the support flange has a positive curvature, and wherein the sealing surface of the foam cushion has a negative curvature at locations where the outer surface of the support flange has a negative curvature.

### Claim 10 (depends on 1)

The patient interface of claim 1, wherein the outer surface of the support flange in the flap portion has a saddle shape.

### Claim 11 (depends on 1)

The patient interface of claim 1, wherein the outer surface of the support flange in the central inferior region has a saddle shape.

### Claim 12 (depends on 1)

The patient interface of claim 1, wherein the outer surface of the support flange in the flap portion is between a first pair of dome regions.

### Claim 13 (depends on 1)

The patient interface of claim 1, wherein the outer surface of the support flange in the central inferior region is between a second pair of dome regions.

### Claim 14 (depends on 1)

The patient interface of claim 1, wherein the foam cushion overhangs the support flange.

### Claim 15 (depends on 1)

The patient interface of claim 1, further comprising a shell with an inlet opening configured to receive the flow of positive pressure respiratory gas, the support wall being mounted to the shell.

### Claim 16 (depends on 15)

The patient interface of claim 15, further comprising a positioning and stabilizing structure configured to support the shell, the support wall, and the foam cushion on the patient's head, the positioning and stabilizing structure being removably attachable to the shell.

### Claim 17 (depends on 16)

The patient interface of claim 16, wherein the positioning and stabilizing structure comprises a shroud and a plurality of headgear straps.

### Claim 18 (depends on 17)

The patient interface of claim 17, wherein the shroud is removably attachable to the shell at the inlet opening.

### Claim 19 (depends on 18)

The patient interface of claim 18, further comprising an air delivery tube connectable to the shroud and the shell.

### Claim 20

A patient interface configured to deliver a flow of positive pressure respiratory gas to an entrance of a patient's airways including at least an entrance of the patient's nares, the patient interface being configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient pressure in use, throughout the patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing, the patient interface comprising:
an elastomeric support wall forming at least part of a plenum chamber configured to receive the flow of positive pressure respiratory gas;
an elastomeric support flange positioned at an end of the elastomeric support wall and extending radially inward from the support wall; and
a foam cushion mounted on the support flange, the foam cushion being configured to form a seal with the patient's face,
wherein an elastomeric wall thickness of the support flange varies from a central superior region of the support flange to a central inferior region of the support flange,
wherein the thickness of the elastomeric support wall is greatest in a thickened region, and
wherein the increased thickness of the thickened region of the elastomeric support wall does not extend into the elastomeric support flange.

### Claim 21 (depends on 20)

The patient interface of claim 20, wherein the elastomeric wall thickness of the support flange is thinner at the central superior region and the central inferior region than in intermediate regions between the central superior region and the central inferior region.

### Claim 22 (depends on 20)

The patient interface of claim 20, wherein the elastomeric wall thickness of the support flange is thinner at the central superior region than at the central inferior region.

### Claim 23 (depends on 20)

The patient interface of claim 20, wherein an elastomeric wall thickness of the support wall varies from a central superior region of the support wall to a central inferior region of the support wall.

### Claim 24 (depends on 23)

The patient interface of claim 23, wherein the elastomeric wall thickness of the support wall is thinner at the central superior region of the support wall and at the central inferior region of the support wall than at intermediate regions between the central superior region and the central inferior region.

### Claim 25 (depends on 23)

The patient interface of claim 23, wherein the elastomeric wall thickness of the support wall is thinner at the central superior region than at the central inferior region.

### Claim 26 (depends on 20)

The patient interface of claim 20, wherein the central superior region of the support wall comprises a superior gusset, and the central inferior region of the support wall comprises an inferior gusset.

### Claim 27 (depends on 26)

The patient interface of claim 26, wherein the inferior gusset is more collapsible than the superior gusset.

### Claim 28 (depends on 20)

The patient interface of claim 20, wherein a thickness of the foam cushion is consistent throughout the foam cushion.

### Claim 29 (depends on 20)

The patient interface of claim 20, further comprising a pair of compressible ribs at an inferior region of the patient interface, each of the compressible ribs being attached to the support wall and the support flange and being configured to prevent at least a portion of the support flange from flexing due to positive pressure in the plenum chamber.

### Claim 30 (depends on 20)

The patient interface of claim 20, wherein the support flange comprises a flap portion at the central superior region of the support flange that extends further in the radially inward direction than the rest of the support flange, and wherein the flap portion is configured to prevent at least a portion of the support flange from flexing due to positive pressure in the plenum chamber.

### Claim 31 (depends on 20)

The patient interface of claim 20, wherein the foam cushion overhangs the support flange.

### Claim 32 (depends on 20)

The patient interface of claim 20, wherein the foam cushion comprises an attachment surface configured to be attached to the support flange and comprises a sealing surface configured to contact and form a seal with the patient's face, wherein the foam cushion is bent around a bisecting plane that bisects the foam cushion and extends through the central superior region and the central inferior region of the foam cushion, and wherein the attachment surface and the sealing surface are wider at the bisecting plane than at the remaining portions of the foam cushion.

### Claim 33 (depends on 32)

The patient interface of claim 32, wherein the foam cushion comprises a perimeter surface extending from the attachment surface to the sealing surface, and wherein the perimeter surface is concave at the central inferior region.

### Claim 34 (depends on 20)

The patient interface of claim 20, further comprising a shell with an inlet opening configured to receive the flow of positive pressure respiratory gas, the support wall being mounted to the shell.

### Claim 35 (depends on 34)

The patient interface of claim 34, further comprising a positioning and stabilizing structure configured to support the shell, the support wall, and the foam cushion on the patient's head, the positioning and stabilizing structure being removably attachable to the shell.

### Claim 36 (depends on 35)

The patient interface of claim 35, wherein the positioning and stabilizing structure comprises a shroud and a plurality of headgear straps.

### Claim 37 (depends on 36)

The patient interface of claim 36, wherein the shroud is removably attachable to the shell at the inlet opening.

### Claim 38 (depends on 37)

The patient interface of claim 37, further comprising an air delivery tube connectable to the shroud and the shell.

### Claim 39

A patient interface configured to deliver a flow of positive pressure respiratory gas to an entrance of a patient's airways including at least an entrance of the patient's nares, the patient interface being configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient pressure in use, throughout the patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing, the patient interface comprising:
a shell with an inlet opening configured to receive the flow of positive pressure respiratory gas;
an elastomeric support wall mounted to the shell, the shell and the elastomeric support wall together forming at least part of a plenum chamber configured to receive the flow of positive pressure respiratory gas, the elastomeric support wall comprising a pair of thickened regions on opposing sides of a plane that bisects the elastomeric support wall and extends from the superior side of the elastomeric support wall to the inferior side of the elastomeric support wall;
an elastomeric support flange positioned at an end of the elastomeric support wall and extending radially inward from the support wall; and
a foam cushion mounted on the support flange, the foam cushion being configured to form a seal with the patient's face,
wherein the inlet opening has a central longitudinal axis that extends through an anterior aperture configured to receive the patient's nose, and
wherein the elastomeric support wall and the foam cushion are configured so that when the patient interface is mounted on the patient's face, a part of the central longitudinal axis extending outwardly from the anterior side of the patient interface extends in an inferior direction,
wherein the thickness of the elastomeric support wall is greatest in the pair of thickened regions, and
wherein the increased thickness of the thickened regions of the elastomeric support wall does not extend into the elastomeric support flange.

### Claim 40 (depends on 39)

The patient interface of claim 39, wherein the support wall is configured to pivot around a lateral axis that extends through lateral sides of the support wall.

### Claim 41 (depends on 40)

The patient interface of claim 40, wherein an inferior portion of the support wall comprises an inferior gusset, and the inferior gusset is configured so that the support wall flexes around the lateral axis when the inferior gusset is collapsed.

### Claim 42 (depends on 39)

The patient interface of claim 39, wherein a superior portion of the support wall comprises a superior gusset.

### Claim 43 (depends on 39)

The patient interface of claim 39, further comprising a positioning and stabilizing structure configured to support the shell, the support wall, and the foam cushion on the patient's head, the positioning and stabilizing structure being removably attachable to the shell.

### Claim 44 (depends on 43)

The patient interface of claim 43, wherein the positioning and stabilizing structure comprises a shroud and a plurality of headgear straps.

### Claim 45 (depends on 44)

The patient interface of claim 44, wherein the shroud is removably attachable to the shell at the inlet opening.

### Claim 46 (depends on 45)

The patient interface of claim 45, further comprising an air delivery tube connectable to the shroud and the shell.
