# US 10,869,981 B2 · Mask system

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- Number: US 10,869,981 B2
- Document ID: US10869981B2
- Status: Granted
- Kind: B2
- Application number: 16/922,398
- Filed: 2020-07-07
- Published: 2020-10-22
- Granted: 2020-12-22
- Earliest claimed: 2010-09-30
- Assignees: ResMed Pty Ltd
- Applicants: ResMed Pty Ltd
- Inventors: Justin John Formica; Jose Ignacio Romagnoli; Philip Rodney Kwok; Joel Edward Gibson; David Anthony Pidcock; Christopher Scott Skipper; Stephen Gray
- Web page: https://patentgrep.com/patent/US10869981B2

## CPC

- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0057: {Pumps therefor}
- 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 16/0622: {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 16/0683: {Holding devices therefor}
- A61M 16/0816: {Joints or connectors}
- A61M 16/0825: {with ball-sockets}
- A61M 16/0875: {Connecting tubes}
- A61M 16/20: Valves specially adapted to medical respiratory devices
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61M 16/0655: {in the form of a linear or curvilinear slide}
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2209/06: Packaging for specific medical equipment
- A61M 2210/0618: Nose
- A61M 2210/0625: Mouth
- 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 mask system for delivery of respiratory therapy to a patient includes a nares portion and a mouth portion and an inlet conduit connected to at least one of the nares portion and the mouth portion to deliver the pressurized, breathable gas. The mask system is adapted to selectively utilize the nares portion and/or the mouth portion in a first mode utilizing both the nares portion and the mouth portion, and in a second mode utilizing the nares portion and not utilizing the mouth portion.

## Claims

### Claim 1

A mask system for delivery of respiratory therapy to a patient, comprising:
a mask shaped to seal entirely below a nasal bridge of the patient and provide pressurized air to a nose of the patient and a mouth of the patient, the mask including:
a mouth seal portion that defines a mouth aperture through which pressurized air is deliverable to the mouth of the patient, and
a nares seal portion that defines a nasal aperture that is spaced apart from the mouth aperture and through which pressurized air is deliverable from an interior of the mask to the nose of the patient through an air flow path, the nares seal portion including:
(i) a support wall that fully surrounds the air flow path, and
(ii) a flexible membrane extending from the support wall towards an edge of the flexible membrane, the flexible membrane shaped to seal around nares of the patient through contact with a tip of the nose and sides of the nose when the mask is worn by the patient, the flexible membrane being integrally formed as a unitary structure with a first thickened portion that provides support to the flexible membrane on a first side of the mask and with a second thickened portion that provides support to the flexible membrane on a second side of the mask opposite from the first side of the mask; and
headgear structured to maintain the mask on a face of the patient when the mask is worn by the patient, the headgear including:
a first side headgear portion attachable to the mask at the first side of the mask so that the first side headgear portion extends between a first eye of the patient and a first ear of the patient on a first side of a head of the patient when the mask is worn by the patient; and
a second side headgear portion attachable to the mask at the second side of the mask so that the second side headgear portion extends between a second eye of the patient and a second ear of the patient on a second side of the head of the patient opposite from the first side of the head of the patient when the mask is worn by the patient.

### Claim 2 (depends on 1)

The mask system of claim 1, wherein:
the first thickened portion comprises a first region of the flexible membrane that is positioned on a first side of the flexible membrane to contact a first side of the nose when the mask is worn by the patient; and
the second thickened portion comprises a second region of the flexible membrane that is positioned on a second side of the flexible membrane to contact a second side of the nose opposite from the first side of the nose when the mask is worn by the patient.

### Claim 3 (depends on 2)

The mask system of claim 2, wherein:
the first thickened portion is separated from the second thickened portion by a nose-tip portion of the flexible membrane that is shaped to contact the tip of the nose when the mask is worn by the patient; and
the first thickened portion and the second thickened portion each have a greater thickness than the nose-tip portion of the flexible membrane.

### Claim 4 (depends on 3)

The mask system of claim 3, wherein:
the first thickened portion is separated from the second thickened portion by an upper lip portion of the flexible membrane that is shaped to contact an upper lip region of the patient when the mask is worn by the patient; and
the first thickened portion and the second thickened portion are each thicker than the upper lip portion of the flexible membrane.

### Claim 5 (depends on 1)

The mask system of claim 1, wherein:
the first thickened portion extends from the support wall; and
the second thickened portion extends from the support wall.

### Claim 6 (depends on 5)

The mask system of claim 5, wherein:
a free edge of the first thickened portion is separated from the flexible membrane by a first air gap; and
a free edge of the second thickened portion is separated from the flexible membrane by a second air gap.

### Claim 7 (depends on 6)

The mask system of claim 6, wherein:
the flexible membrane is stretchable towards the free edge of the first thickened portion when the mask is worn by the patient and the flexible membrane contacts the nose of the patient; and
the flexible membrane is stretchable towards the free edge of the second thickened portion when the mask is worn by the patient and the flexible membrane contacts the nose of the patient.

### Claim 8 (depends on 7)

The mask system of claim 7, wherein:
the first thickened portion includes a first cored out portion; and
the second thickened portion includes a second cored out portion.

### Claim 9 (depends on 8)

The mask system of claim 8, wherein:
the free edge of the first thickened portion defines and surrounds a first opening to the first cored out portion; and
the free edge of the second thickened portion defines and surrounds a second opening to the second cored out portion.

### Claim 10 (depends on 1)

The mask system of claim 1, wherein:
a width of an upper portion of the first thickened portion proximal the flexible membrane is greater than a width of a lower portion of the first thickened portion distal the flexible membrane; and
a width of an upper portion of the second thickened portion proximal the flexible membrane is greater than a width of a lower portion of the second thickened portion distal the flexible membrane.

### Claim 11 (depends on 1)

The mask system of claim 1, wherein the nares seal portion is shaped to contact an underside of the nose of the patient when the mask is worn by the patient.

### Claim 12 (depends on 1)

The mask system of claim 1, wherein the nasal aperture is shaped to contemporaneously provide pressurized air to both nares of the patient.

### Claim 13 (depends on 1)

The mask system of claim 1, wherein sides of the flexible membrane are shaped to seal with the sides of the nose of the patient when the mask is worn by the patient.

### Claim 14 (depends on 1)

The mask system of claim 1, wherein the flexible membrane, the first thickened portion, and the second thickened portion are integrally formed from silicone as a unitary structure.

### Claim 15 (depends on 1)

The mask system of claim 1, wherein the mouth seal portion includes a mouth sealing membrane that defines the mouth aperture.

### Claim 16 (depends on 15)

The mask system of claim 15, wherein the mouth sealing membrane is shaped to contact a front of a chin of the patient when the mask is worn by the patient.

### Claim 17 (depends on 16)

The mask system of claim 16, wherein the mouth sealing membrane is shaped to contact cheeks of the patient and an upper lip region of the patient when the mask is worn by the patient.

### Claim 18 (depends on 17)

The mask system of claim 17, wherein a portion of the mouth sealing membrane positioned to contact the upper lip region of the patient is more flexible than side portions of the mouth sealing membrane positioned to contact the cheeks of the patient when the mask is worn by the patient.

### Claim 19 (depends on 1)

The mask system of claim 1, wherein the mouth seal portion and the nares seal portion are integrally formed from silicone as a unitary structure.

### Claim 20 (depends on 1)

The mask system of claim 1, wherein the mask includes means for connecting the mouth seal portion and the nares seal portion together.

### Claim 21 (depends on 20)

The mask system of claim 20, wherein the mask includes a rigid frame that includes means for connecting to the mouth seal portion and the nares seal portion.

### Claim 22 (depends on 21)

The mask system of claim 21, wherein the mask includes means for venting gas exhaled by the patient.

### Claim 23 (depends on 22)

The mask system of claim 22, further comprising means for delivering pressurized air to the mask.

### Claim 24

A mask system for delivery of respiratory therapy to a patient, comprising:
a mask shaped to seal entirely below a nasal bridge of the patient and provide pressurized air to a nose of the patient and a mouth of the patient, the mask including:
a mouth seal portion that defines a mouth aperture through which pressurized air is deliverable to the mouth of the patient, the mouth seal portion including a mouth sealing membrane that defines the mouth aperture, the mouth sealing membrane being shaped to contact a front of a chin of the patient, cheeks of the patient, and an upper lip region of the patient when the mask is worn by the patient, and
a nares seal portion that defines a nasal aperture that is spaced apart from the mouth aperture and through which pressurized air is deliverable from an interior of the mask to the nose of the patient through an air flow path, the nares seal portion and the mouth seal portion being integrally formed from silicone as a unitary structure, the nasal aperture being shaped to contemporaneously provide pressurized air to both nares of the patient, the nares seal portion including (i) a support wall that fully surrounds the air flow path, and (ii) a flexible membrane extending from the support wall towards an edge of the flexible membrane, the flexible membrane shaped to seal around nares of the patient through contact with a tip of the nose and sides of the nose when the mask is worn by the patient, the flexible membrane being integrally formed from silicone as part of the unitary structure with a first thickened portion that provides support to the flexible membrane on a first side of the mask and with a second thickened portion that provides support to the flexible membrane on a second side of the mask opposite from the first side of the mask; and
headgear structured to maintain the mask on a face of the patient when the mask is worn by the patient, the headgear including:
a first side headgear portion attachable to the mask at the first side of the mask so that the first side headgear portion extends between a first eye of the patient and a first ear of the patient on a first side of a head of the patient when the mask is worn by the patient; and
a second side headgear portion attachable to the mask at the second side of the mask so that the second side headgear portion extends between a second eye of the patient and a second ear of the patient on a second side of the head of the patient opposite from the first side of the head of the patient when the mask is worn by the patient.

### Claim 25 (depends on 24)

The mask system of claim 24, wherein:
the first thickened portion comprises a first region of the flexible membrane that is positioned on a first side of the flexible membrane to contact a first side of the nose when the mask is worn by the patient;
the second thickened portion comprises a second region of the flexible membrane that is positioned on a second side of the flexible membrane to contact a second side of the nose opposite from the first side of the nose when the mask is worn by the patient;
the first thickened portion is separated from the second thickened portion by a nose-tip portion of the flexible membrane that is shaped to contact the tip of the nose when the mask is worn by the patient;
the first thickened portion and the second thickened portion each have a greater thickness than the nose-tip portion of the flexible membrane;
the first thickened portion is separated from the second thickened portion by an upper lip portion of the flexible membrane that is shaped to contact an upper lip region of the patient when the mask is worn by the patient; and
the first thickened portion and the second thickened portion are each thicker than the upper lip portion of the flexible membrane.

### Claim 26 (depends on 24)

The mask system of claim 24, wherein:
the first thickened portion extends from the support wall;
the second thickened portion extends from the support wall;
a free edge of the first thickened portion is separated from the flexible membrane by a first air gap;
a free edge of the second thickened portion is separated from the flexible membrane by a second air gap;
the flexible membrane is stretchable towards the free edge of the first thickened portion when the mask is worn by the patient and the flexible membrane contacts the nose of the patient; and
the flexible membrane is stretchable towards the free edge of the second thickened portion when the mask is worn by the patient and the flexible membrane contacts the nose of the patient.
