# US 10,946,155 B2 · Valsalva mask

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- Number: US 10,946,155 B2
- Document ID: US10946155B2
- Status: Granted
- Kind: B2
- Application number: 15/960,196
- Filed: 2018-04-23
- Published: 2018-10-11
- Granted: 2021-03-16
- Earliest claimed: 2012-09-04
- Assignees: Fisher & Paykel Healthcare Limited
- Applicants: Fisher & Paykel Healthcare Limited
- Inventors: Matthew Roger Stephenson; Melissa Catherine Bornholdt
- Web page: https://patentgrep.com/patent/US10946155B2

## CPC

- A61M 16/0605: {Means for improving the adaptation of the mask to the patient}
- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0633: {with forehead support}
- A61M 16/065: {in the form of a pivot}
- A61M 16/0683: {Holding devices therefor}
- A61M 16/0825: {with ball-sockets}
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61M 16/0616: {with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure}
- A61M 2205/15: Detection of leaks
- 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

An interface for positive pressure therapy includes a mask assembly and a headgear assembly. The mask assembly comprises a mask seal that is adapted to underlie the nose. The mask seal extends up the lateral sides of the nose. The mask seal has a primary seal below the nose and a secondary seal alongside the nose.

## Claims

### Claim 1

A mask assembly for use with a respiratory interface configured to provide respiratory gas to a user in use and providing additional lateral compressive forces against a user's nose for nose bridge support and to reduce air leakage, the mask assembly comprising:
a mask base comprising a mask base wall made of a first material, the mask base wall having a distal portion defining a respiratory gases inlet, the mask base wall extending from the distal portion, around the respiratory gases inlet and configured to extend proximally toward a user in use, to a proximal peripheral edge of the mask base wall, the mask base wall having an inner mask base wall surface;
a seal member made of a second material that is more flexible than the first material, the seal member having a distal peripheral edge, a sidewall portion, a face contacting wall portion, and a free edge of the face contacting wall portion, the distal peripheral edge being connected to the proximal peripheral edge of the mask base wall, the sidewall portion extending from the distal peripheral edge of the seal member and configured to extend proximally toward a user in use, to the face contacting wall portion of the seal member, the free edge of the face contacting wall portion disposed radially inwardly from the sidewall portion, the sidewall portion having a sidewall outer surface facing radially outwardly and the face contacting wall portion having a face contacting wall outer surface configured to face toward a user in use, wherein the sidewall portion and the face contacting wall portion have a sidewall inner surface and a face contacting wall inner surface, respectively, and wherein the sidewall inner surface, the face contacting wall inner surface, and the inner mask base wall surface define an inwardly facing surface of the mask assembly;
a first tab integrally formed with the seal member, the first tab having a first proximal end and a first distal end, the first proximal end of the first tab extending from the face contacting wall inner surface at a first location spaced from the free edge to the first distal end of the first tab which is connected with the inwardly facing surface of the mask assembly at a second location that is disposed distally from the face contacting wall portion, the first tab having a first thickness, a first length and first and second side edges defining a first width, the first length defined as extending from the first proximal end to the first distal end, the first tab forming a first loop with the inwardly facing surface of the mask assembly and configured to press at least part of the face contacting wall outer surface laterally against a first side of a user's nose in use; and
a second tab integrally formed with the seal member, the second tab having a second proximal end and a second distal end, the second proximal end of the second tab extending from the face contacting wall inner surface at a third location spaced from the free edge to the second distal end of the second tab which is connected with the inwardly facing surface of the mask assembly at a fourth location that is disposed distally from the face contacting wall portion, the second tab having a second thickness, a second length and third and fourth side edges defining a second width, the second length defined as extending from the proximal end to the distal end, the second tab forming a second loop with the inwardly facing surface of the mask assembly and configured to press at least part of the face contacting wall outer surface laterally against a second side of the user's nose in use.

### Claim 2 (depends on 1)

The mask assembly according to claim 1, wherein the distal ends of the first and second tabs are each adjustably connected to respective portions of the mask assembly.

### Claim 3 (depends on 1)

The mask assembly according to claim 1, wherein the face contacting wall portion comprises first and second face contacting wall portions extending radially inwardly from the proximal ends of the first and second tabs, respectively, and wherein the first and second tabs taper in width toward the distal ends, respectively.

### Claim 4

A mask assembly for use with a respiratory interface configured to provide respiratory gas to a user, the mask assembly comprising:
a mask base comprising a mask base wall extending from a distal portion to a peripheral portion of the mask base wall, the mask base wall having an inner base wall surface;
a seal member having a distal peripheral portion, a sidewall portion, and a face contacting wall portion, the distal peripheral portion being connected to the peripheral portion of the mask base wall, the sidewall portion extending from the distal peripheral portion of the seal member and configured to extend proximally toward a user in use, to the face contacting wall portion of the seal member, wherein the sidewall portion and the face contacting wall portion comprise a sidewall inner surface and a face contacting wall inner surface, respectively, and wherein the face contacting wall inner surface, the sidewall inner surface, and the inner base wall surface define an inwardly facing surface of the mask assembly;
a first tab having a first proximal end and a first distal end, the first proximal end of the first tab extending from the face contacting wall inner surface to the first distal end of the first tab which is connected with the inwardly facing surface of the mask assembly at a location that is disposed distally from the proximal end such that the first tab forms a first loop with the inwardly facing surface of the mask assembly, wherein the first tab includes a first thickness, a first length, and first and second side edges defining a first width, the first length defined as extending from the first proximal end to the first distal end; and
a second tab having a second proximal end and a second distal end, the second proximal end of the second tab extending from the face contacting wall inner surface to a location disposed distally from the second proximal end of the second tab such that the second tab forms a second loop with the inwardly facing surface of the mask assembly.

### Claim 5 (depends on 4)

The mask assembly according to claim 4, wherein the mask base wall is made of a first material and the seal member is made of a second material that is more flexible than the first material.

### Claim 6 (depends on 4)

The mask assembly according to claim 4, wherein the first proximal end of the first tab is spaced from a free edge of the face contacting wall portion, the free edge of the face contacting wall portion being disposed radially inwardly from the sidewall portion.

### Claim 7 (depends on 4)

The mask assembly according to claim 4, wherein the first tab is integrally formed with the seal member.

### Claim 8 (depends on 4)

The mask assembly according to claim 4, wherein the first tab is configured to press at least part of an outer surface of the face contacting wall portion laterally against a first lateral side of a user's nose in use.

### Claim 9 (depends on 8)

The mask assembly according to claim 8, wherein the second proximal end of the second tab is spaced from a free edge of the face contacting wall portion, the second tab configured to press at least part of an outer surface of the face contacting wall portion laterally against a second side of a user's nose in use, opposite the first lateral side of the user's nose.

### Claim 10 (depends on 4)

The mask assembly according to claim 4, wherein the first and second distal ends of the first and second tabs are each adjustably connected to respective portions of the mask assembly.

### Claim 11 (depends on 4)

The mask assembly according to claim 4, wherein the peripheral portion of the mask base wall comprises a peripheral edge, the distal peripheral portion of the seal member comprises a distal peripheral edge, and the distal peripheral edge is connected to the peripheral edge of the mask base wall.

### Claim 12 (depends on 4)

The mask assembly according to claim 4, wherein the distal portion of the mask base wall defines a respiratory gases inlet.

### Claim 13

A mask assembly for use with a respiratory interface configured to provide respiratory gas to a user, the mask assembly comprising:
a mask base comprising a distal inlet and a proximal peripheral edge;
a seal member having a sidewall portion and a face contacting wall portion, the sidewall portion being connected to the proximal peripheral edge of the mask base;
a first tab extending from a first proximal location on an inner surface of the face contacting wall portion to a first distal location of the mask assembly that is disposed distally from the first proximal location, wherein the first tab forms a first loop with an inner surface of the mask assembly, and wherein the first tab includes first and second side edges extending from the first proximal location to the first distal location; and
a second tab having a proximal end and a distal end, the proximal end of the second tab extending from a second proximal location on the seal member to a second distal location disposed distally from the second proximal location so as to form a second loop with the inner surface of the mask assembly.

### Claim 14 (depends on 13)

The mask assembly according to claim 13, wherein the first tab comprise a first width defined by the first and second side edges.

### Claim 15 (depends on 13)

The mask assembly according to claim 13, wherein the first tab comprises a first thickness and a first length, the first length defined as extending from the first proximal location to the first distal location.

### Claim 16 (depends on 13)

The mask assembly according to claim 13, wherein the sidewall portion comprises a sidewall inner surface, the face contacting wall portion comprises a face contacting wall inner surface, and the mask base comprises a mask base inner surface, and wherein the face contacting wall inner surface, the sidewall inner surface, and the mask base inner surface define the inner surface of the mask assembly.

### Claim 17 (depends on 13)

The mask assembly according to claim 13, wherein the face contacting wall portion comprises a free edge, wherein a proximal end of the first tab is spaced from the free edge of the face contacting wall portion, the free edge of the face contacting wall portion being disposed radially inwardly from the sidewall portion.

### Claim 18 (depends on 13)

The mask assembly according to claim 13, wherein the sidewall portion comprises a sidewall outer surface facing radially outwardly and the face contacting wall portion comprises a face contacting wall outer surface configured to face toward a user in use.

### Claim 19 (depends on 18)

The mask assembly according to claim 18, wherein the second tab is configured to press at least a second part of the outer surface of the face contacting wall portion laterally against a second side of a user's nose in use, opposite the first lateral side.

### Claim 20 (depends on 13)

The mask assembly according to claim 13, wherein a distal end of the first tab is adjustably connected to a portion of the mask assembly.

### Claim 21 (depends on 13)

The mask assembly according to claim 13, wherein the first tab is integrally formed with the seal member.
