# US 11,077,274 B2 · Mask system with snap-fit shroud

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- Number: US 11,077,274 B2
- Document ID: US11077274B2
- Status: Granted
- Kind: B2
- Application number: 15/964,887
- Filed: 2018-04-27
- Published: 2018-08-30
- Granted: 2021-08-03
- Earliest claimed: 2008-03-04
- Assignees: ResMed Pty Ltd
- Applicants: ResMed Pty Ltd
- Inventors: Eva Ng; David James Lockwood; Jamie Graeme Wehbeh; Zoran Valcic; Errol Savio Alex D'Souza; Matthew Eves; Mahsita Sari
- Web page: https://patentgrep.com/patent/US11077274B2

## CPC

- A61M 16/0622: {having an underlying cushion}
- A61M 16/0057: {Pumps therefor}
- 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 16/0683: {Holding devices therefor}
- A61M 16/0694: {Chin straps}
- A61M 16/0816: {Joints or connectors}
- A61M 16/0858: {Pressure sampling ports}
- A61M 16/0875: {Connecting tubes}
- A61M 16/20: Valves specially adapted to medical respiratory devices
- A61M 16/0633: {with forehead support}
- A61M 16/0825: {with ball-sockets}
- A61M 16/0841: {for sampling}
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61M 2016/0661: {with customised shape}
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2209/06: Packaging for specific medical equipment
- 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 shroud (1020) for a mask system includes a retaining portion structured to retain a frame (1040), a pair of upper headgear connectors (1024) each including an elongated arm (1026) and a slot (1027) at the free end of the arm adapted to receive a headgear strap, and a pair of lower headgear connectors (1025) each adapted to attach to a headgear strap. The retaining portion, the upper headgear connectors, and the lower headgear connectors are integrally formed as a one piece structure.

## Claims

### Claim 1

A mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment, the mask system comprising:
a shroud module;
a cushion module connected to the shroud module and adapted to seal against the patient's face in use;
an elbow module rotatably attached to the shroud module such that the shroud module acts as a carrier and bearing surface for the elbow module and the elbow module is rotatable 360° relative to the shroud module in use, and the elbow module being adapted to be connected to an air delivery tube that delivers the supply of gas at positive pressure to the patient; and
headgear removably attachable to the shroud module to maintain the cushion module in a sealing position on the patient's face,
wherein:
the cushion module includes a frame and a cushion, the frame and the cushion at least partly forming a breathing chamber when the cushion contacts the patient's face in use,
the shroud module and the frame are shaped to inhibit relative rotation when the shroud module is attached to the frame,
an outer portion of the frame remains uncovered by the shroud module when the shroud module is attached to the frame,
the frame and cushion together comprise an integrated component, the frame being constructed from a relatively rigid material that interfaces with the shroud module when the shroud module is attached to the frame, the cushion being constructed from a relatively flexible silicone material that contacts the patient's face in use, and the relatively rigid material of the frame being a more rigid material than the relatively flexible silicone material of the cushion,
the shroud module includes a part-annular retaining portion that is structured to retain the frame and the elbow module, and
the part-annular retaining portion includes a pair of first interfacing structures and the frame includes a pair of second interfacing structures, the first interfacing structures being structured to removably connect to corresponding ones of the second interfacing structures with a snap-fit.

### Claim 2 (depends on 1)

The mask system of claim 1, wherein:
the cushion comprises a sealing portion adapted to seal around the patient's nose and mouth in use, and
the cushion is adapted to engage the patient's face generally along nasal, cheek, and chin regions of the patient's face.

### Claim 3 (depends on 1)

The mask system of claim 1, further comprising a vent arrangement configured to wash out gas from the mask system during use,
wherein:
the elbow module includes an elbow and an anti-asphyxia valve,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the shroud module, the second end portion having a swivel joint adapted to be connected to the air delivery tube, and
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas.

### Claim 4 (depends on 1)

The mask system of claim 1, wherein the shroud module is structured to maintain the elbow module in an operative position with respect to the patient's face, and the shroud module and the elbow module being connected with a mechanical interlock.

### Claim 5 (depends on 1)

The mask system of claim 1, further comprising a concertina section provided in a region of the cushion that is configured to contact the patient's nose proximate the nasal bridge in use, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the frame.

### Claim 6 (depends on 1)

The mask system of claim 1, wherein the mask system further comprises a number of differently sized cushion modules each having a cushion and a frame joined together, the frame of each cushion module including a common configuration for interfacing with the shroud module in a modular arrangement that allows the shroud module to be selectively and removably coupled to each of the number of differently sized cushion modules, wherein the differently sized cushion modules include different size cushions, including small, medium, and large.

### Claim 7 (depends on 1)

The mask system of claim 1, wherein the relatively rigid material and the relatively flexible silicone material are joined by a co-molded connection, the relatively rigid material being polycarbonate.

### Claim 8 (depends on 7)

The mask system of claim 7, wherein the co-molded connection between the polycarbonate and the relatively flexible silicone material extends around respective perimeters of the frame and the cushion such that the cushion is oriented to extend from the co-molded connection towards the patient's face in use and the frame extends away from the co-molded connection and towards the shroud module.

### Claim 9 (depends on 1)

The mask system of claim 1, further comprising:
a vent arrangement configured to wash out gas from the mask system during use; and
a concertina section provided in a region of the cushion that is configured to contact the patient's nose proximate the nasal bridge in use, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the frame,
wherein:
the cushion comprises a sealing portion adapted to seal around the patient's nose and mouth in use,
the cushion is adapted to engage the patient's face generally along nasal, cheek, and chin regions of the patient's face,
the elbow module includes an elbow and an anti-asphyxia valve,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the shroud module, the second end portion having a swivel joint adapted to be connected to the air delivery tube,
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas,
the shroud module is structured to maintain the elbow module in an operative position with respect to the patient's face, and the shroud module and the elbow module being connected with a mechanical interlock,
the shroud module includes a forehead support,
the shroud module includes upper and lower headgear connectors on each side of the shroud module,
each upper headgear connector includes a slot adapted to receive a respective headgear strap in use,
a headgear clip is adapted to be removably interlocked with each lower headgear connector,
the headgear includes a pair of upper straps and a pair of lower straps, with the upper straps being removably attached to respective ones of the upper headgear connectors and the lower straps being connected to a respective headgear clip, and
a free end of each of the upper straps and each of the lower straps includes a hook tab structured to engage a remainder of the respective upper strap and the respective lower strap to secure the upper straps and the lower straps in place in a length adjustable manner.

### Claim 10

A mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment, the mask system comprising:
a shroud module acting as a carrier having a bearing surface;
a cushion module that is snap-fit to the shroud module and adapted to seal against the patient's face in use; and
an elbow module connected to the shroud module, the elbow module being rotatably attached to the bearing surface of the carrier such that, in use, the elbow module is rotatable 360° relative to the shroud module, and the elbow module is adapted to be connected to an air delivery tube that delivers the supply of gas at positive pressure to the patient,
wherein the cushion module includes a frame and a cushion, the frame and the cushion at least partly forming a breathing chamber when the cushion contacts the patient's face in use,
wherein the frame and the cushion together comprise an integrated component, the frame being constructed from a relatively rigid material adapted to directly contact the shroud module when the shroud module is attached to the frame, and the cushion being constructed from a relatively flexible silicone material adapted to interface with patient's face in use,
wherein the shroud module and the frame are shaped such that the shroud module and the frame are not rotatable relative to one another when the shroud module and the frame are attached,
wherein the relatively rigid material is a more rigid material than the relatively flexible silicone material,
wherein the shroud module includes a part-annular retaining portion that is structured to retain the frame and the elbow module, and
wherein the part-annular retaining portion includes a pair of first interfacing structures and the frame includes a pair of second interfacing structures, the first interfacing structures being structured to removably connect to corresponding ones of the second interfacing structures to snap-fit the cushion module to the shroud module.

### Claim 11 (depends on 10)

The mask system of claim 10, wherein:
the cushion comprises a sealing portion adapted to seal around the patient's nose and mouth in use, and
the cushion is adapted to engage the patient's face generally along nasal, cheek, and chin regions of the patient's face.

### Claim 12 (depends on 10)

The mask system of claim 10, further comprising a concertina section provided in a region of the cushion that is configured to contact the patient's nose proximate the nasal bridge in use, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the frame.

### Claim 13 (depends on 10)

The mask system of claim 10, further comprising a concertina section provided in a region of the cushion that is configured to contact the patient's nose proximate the nasal bridge in use, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the frame,
wherein:
the cushion comprises a sealing portion adapted to seal around the patient's nose and mouth in use,
the cushion is adapted to engage the patient's face generally along nasal, cheek, and chin regions of the patient's face,
the frame includes an opening that is adapted to communicate with the elbow module, and
at least a portion of the frame is not covered by the shroud module when the cushion module and the shroud module are attached to one another.

### Claim 14 (depends on 10)

The mask system of claim 10, wherein at least a portion of the frame is not covered by the shroud module when the cushion module and the shroud module are attached to one another.

### Claim 15 (depends on 10)

The mask system of claim 10, wherein the relatively rigid material and the relatively flexible silicone material are connected by a co-molded joint, the relatively rigid material being polycarbonate.

### Claim 16 (depends on 15)

The mask system of claim 15, wherein the co-molded joint between the polycarbonate and the relatively flexible silicone material extends around respective perimeters of the frame and the cushion such that when worn by the patient the cushion is oriented to extend from the co-molded joint towards the patient's face and the frame is oriented to extend away from the co-molded joint and towards the shroud module.

### Claim 17 (depends on 10)

The mask system of claim 10, further comprising:
a vent arrangement configured to wash out gas from the mask system during use; and
a concertina section provided in a region of the cushion that is configured to contact the patient's nose proximate the nasal bridge in use, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the frame,
wherein:
the cushion comprises a sealing portion adapted to seal around the patient's nose and mouth in use,
the cushion is adapted to engage the patient's face generally along nasal, cheek, and chin regions of the patient's face,
the elbow module includes an elbow and an anti-asphyxia valve,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the shroud module, the second end portion having a swivel joint adapted to be connected to the air delivery tube,
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas,
the shroud module is structured to maintain the elbow module in an operative position with respect to the patient's face, and the shroud module and the elbow module being connected with a mechanical interlock,
the shroud module includes a forehead support,
the shroud module includes upper and lower headgear connectors on each side of the shroud module,
each upper headgear connector includes a slot adapted to receive a respective headgear strap in use,
a headgear clip is adapted to be removably interlocked with each lower headgear connector,
the headgear includes a pair of upper straps and a pair of lower straps, with the upper straps being removably attached to respective ones of the upper headgear connectors and the lower straps being connected to a respective headgear clip, and
a free end of each of the upper straps and each of the lower straps includes a hook tab structured to engage a remainder of the respective upper strap and the respective lower strap to secure the upper straps and the lower straps in place in a length adjustable manner.

### Claim 18

A mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment, the mask system comprising:
a shroud module acting as a carrier having a bearing surface;
a cushion module that is snap-fit to the shroud module and adapted to seal against the patient's face in use; and
an elbow module connected to the shroud module, the elbow module being rotatably attached to the bearing surface of the carrier such that, in use, the elbow module is rotatable 360° relative to the shroud module, and the elbow module is adapted to be connected to an air delivery tube that delivers the supply of gas at positive pressure to the patient,
wherein the cushion module includes a frame and a cushion, the frame and the cushion at least partly forming a breathing chamber when the cushion contacts the patient's face in use,
wherein the frame and the cushion together comprise an integrated component, the frame being constructed from a relatively rigid material adapted to directly contact the shroud module when the shroud module is attached to the frame, and the cushion being constructed from a relatively flexible silicone material adapted to interface with patient's face in use,
wherein the shroud module and the frame are shaped such that the shroud module and the frame are not rotatable relative to one another when the shroud module and the frame are attached,
wherein the relatively rigid material is a more rigid material than the relatively flexible silicone material
wherein the shroud module includes a pair of upper headgear connectors and a pair of lower headgear connectors configured to connect with the headgear,
wherein the headgear is removably attachable to the upper headgear connectors and the lower headgear connectors to maintain the cushion module in a sealing position on the patient's face in use,
wherein the headgear includes a pair of upper straps and a pair of lower straps with the upper straps removably attachable to respective ones of the upper headgear connectors and the lower straps removably attachable to respective ones of the lower headgear connectors, each of the upper straps and each of the lower straps having a free end and a tab portion proximate the free end, and the tab portion structured to adjustably engage a remainder of a corresponding one of the upper straps and the lower straps with a hook and loop connection to removably secure the corresponding one of the upper straps and the lower straps in place, and
wherein the shroud module includes a pair of arms, each of the arms having a free end and a slot at the free end that forms one of the upper headgear connectors, the slot being adapted to receive a respective headgear strap of the headgear, each of the arms being semi-rigid to stabilize the cushion module against the patient's face in use, and each of the arms being shaped to extend between corresponding ones of the patient's eyes and ears in use.

### Claim 19 (depends on 18)

The mask system of claim 18, wherein:
each of the arms includes a fabric sleeve to protect the patient's skin from irritation,
the shroud includes an annular retaining portion structured to retain the frame and the elbow module,
the cushion comprises a sealing portion adapted to seal around the patient's nose and mouth in use,
the cushion is adapted to engage the patient's face generally along nasal, cheek, and chin regions of the patient's face,
the frame includes an opening that is adapted to communicate with the elbow module,
at least a portion of the frame is not covered by the shroud module when the cushion module and the shroud module are attached to one another,
the elbow module includes a vent arrangement configured to wash out gas from the mask system during use;
the elbow module includes an elbow and an anti-asphyxia valve,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the shroud module, the second end portion having a swivel joint adapted to be connected to the air delivery tube,
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas,
the shroud module is structured to maintain the elbow module in an operative position with respect to the patient's face, and the shroud module and the elbow module being connected with a mechanical interlock,
the relatively rigid material and the relatively flexible silicone material are joined by a co-molded connection, the relatively rigid material being polycarbonate, and the co-molded connection does not include a mechanical interlock.

### Claim 20 (depends on 18)

The mask system of claim 18, wherein:
the cushion comprises a sealing portion adapted to seal around the patient's nose and mouth in use, and
the cushion is adapted to engage the patient's face generally along nasal, cheek, and chin regions of the patient's face.

### Claim 21 (depends on 18)

The mask system of claim 18, wherein at least a portion of the frame is not covered by the shroud module when the cushion module and the shroud module are attached to one another.

### Claim 22 (depends on 18)

The mask system of claim 18, wherein the relatively rigid material and the relatively flexible silicone material are connected by a co-molded joint, the relatively rigid material being polycarbonate.

### Claim 23 (depends on 22)

The mask system of claim 22, wherein the co-molded joint between the polycarbonate and the relatively flexible silicone material extends around respective perimeters of the frame and the cushion such that when worn by the patient the cushion is oriented to extend from the co-molded joint towards the patient's face and the frame is oriented to extend away from the co-molded joint and towards the shroud module.

### Claim 24

A mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment, the mask system comprising:
a shroud module;
a cushion module connected to the shroud module and adapted to seal against the patient's face in use;
an elbow module rotatably attached to the shroud module such that the shroud module acts as a carrier and bearing surface for the elbow module and the elbow module is rotatable 360° relative to the shroud module in use, and the elbow module being adapted to be connected to an air delivery tube that delivers the supply of gas at positive pressure to the patient; and
headgear removably attachable to the shroud module to maintain the cushion module in a sealing position on the patient's face,
wherein the cushion module includes a frame and a cushion, the frame and the cushion at least partly forming a breathing chamber when the cushion contacts the patient's face in use,
wherein the shroud module and the frame are shaped to inhibit relative rotation when the shroud module is attached to the frame,
wherein an outer portion of the frame remains uncovered by the shroud module when the shroud module is attached to the frame,
wherein the frame and cushion together comprise an integrated component, the frame being constructed from a relatively rigid material that interfaces with the shroud module when the shroud module is attached to the frame, the cushion being constructed from a relatively flexible silicone material that contacts the patient's face in use, and the relatively rigid material of the frame being a more rigid material than the relatively flexible silicone material of the cushion,
wherein the shroud module includes a pair of upper headgear connectors and a pair of lower headgear connectors configured to connect with the headgear,
wherein the headgear is removably attachable to the upper headgear connectors and the lower headgear connectors to maintain the cushion module in a sealing position on the patient's face in use, and
wherein the headgear includes a pair of upper straps and a pair of lower straps with the upper straps removably attachable to respective ones of the upper headgear connectors and the lower straps removably attachable to respective ones of the lower headgear connectors, each of the upper straps and each of the lower straps having a free end and a tab portion proximate the free end, and the tab portion structured to adjustably engage a remainder of a corresponding one of the upper straps and the lower straps with a hook and loop connection to removably secure the corresponding one of the upper straps and the lower straps in place, and
wherein the shroud module includes a pair of arms, each of the arms having a free end and a slot at the free end that forms one of the upper headgear connectors, the slot being adapted to receive a respective headgear strap of the headgear, each of the arms being semi-rigid to stabilize the cushion module against the patient's face in use, and each of the arms being shaped to extend between corresponding ones of the patient's eyes and ears in use.

### Claim 25 (depends on 24)

The mask system of claim 24, wherein:
each of the arms includes a fabric sleeve to protect the patient's skin from irritation,
the shroud includes an annular retaining portion structured to retain the frame and the elbow module,
the cushion comprises a sealing portion adapted to seal around the patient's nose and mouth in use,
the cushion is adapted to engage the patient's face generally along nasal, cheek, and chin regions of the patient's face,
the elbow module includes a vent arrangement configured to wash out gas from the mask system during use;
the elbow module includes an elbow and an anti-asphyxia valve,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the shroud module, the second end portion having a swivel joint adapted to be connected to the air delivery tube,
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas,
the shroud module is structured to maintain the elbow module in an operative position with respect to the patient's face, and the shroud module and the elbow module being connected with a mechanical interlock,
the relatively rigid material and the relatively flexible silicone material are joined by a co-molded connection, the relatively rigid material being polycarbonate, and
the co-molded connection does not include a mechanical interlock.

### Claim 26 (depends on 24)

The mask system of claim 24, wherein:
the cushion comprises a sealing portion adapted to seal around the patient's nose and mouth in use, and
the cushion is adapted to engage the patient's face generally along nasal, cheek, and chin regions of the patient's face.

### Claim 27 (depends on 24)

The mask system of claim 24, further comprising a vent arrangement configured to wash out gas from the mask system during use,
wherein:
the elbow module includes an elbow and an anti-asphyxia valve,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the shroud module, the second end portion having a swivel joint adapted to be connected to the air delivery tube, and
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas.

### Claim 28 (depends on 24)

The mask system of claim 24, wherein the shroud module is structured to maintain the elbow module in an operative position with respect to the patient's face, and the shroud module and the elbow module being connected with a mechanical interlock.

### Claim 29 (depends on 24)

The mask system of claim 24, wherein the relatively rigid material and the relatively flexible silicone material are joined by a co-molded connection, the relatively rigid material being polycarbonate.

### Claim 30 (depends on 29)

The mask system of claim 29, wherein the co-molded connection between the polycarbonate and the relatively flexible silicone material extends around respective perimeters of the frame and the cushion such that the cushion is oriented to extend from the co-molded connection towards the patient's face in use and the frame extends away from the co-molded connection and towards the shroud module.

### Claim 31 (depends on 29)

The mask system of claim 29, wherein the co-molded connection does not include a mechanical interlock.

### Claim 32 (depends on 31)

The mask system of claim 31, wherein the co-molded connection between the polycarbonate and the relatively flexible silicone material extends around respective perimeters of the frame and the cushion such that the cushion is oriented to extend from the co-molded connection towards the patient's face in use and the frame extends away from the co-molded connection and towards the shroud module.