Mask system with snap-fit shroud

• US 9,950,131 B2
• Filed: 08/21/2017
• Issued: 04/24/2018
• Est. Priority Date: 03/04/2008
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Ng, Eva, Lockwood, David James, Wehbeh, Jamie Graeme, Valcic, Zoran, D'Souza, Errol Savio Alex, Eves, Matthew, Sari, Mahsita
• Primary Examiner(s): Ditmer, Kathryn E
• Application Number:
  US15/682,117
• Publication Number:
  US 20170340850A1
• Time in Patent Office: 246 Days
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0611 with a gusset portion
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0694 Chin straps
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0841 for sampling
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0661 with customised shape
• CPC Class Codes: A61M 2202/0085 product washed out
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment

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

1. A mask system to provide positive air pressure therapy to a patient, the mask system comprising:

a cushion module comprising a frame and a cushion;

the frame comprising;

an internal surface that at least partly forms a breathing chamber and an external surface opposite the internal surface;

a circular frame opening configured to receive a supply of air at positive pressure;

a cylindrical collar projecting from the frame and surrounding the circular frame opening, the cylindrical collar having a longitudinal axis; and

a vent arrangement including a vent-wall, a lower wall, and two lateral side walls, the vent-wall having a plurality of holes for gas washout from the breathing chamber to atmosphere, the vent-wall being spaced from the external surface of the frame by the lower wall and the two lateral side walls, and the vent arrangement being positioned on the frame such that the vent arrangement is superior to the frame opening in use;

wherein the frame, including the vent arrangement and the cylindrical collar, is constructed from a single piece of a first material; and

the cushion being constructed of an elastomeric material that is a different material from the first material, the first material being harder than the elastomeric material, the frame being more rigid than the cushion, and the cushion being configured to seal against the patient'"'"'s face in use to enable the supply of air at positive pressure to be delivered to at least the patient'"'"'s nose, and

wherein the cushion and the frame are joined to form a one-piece, integrated component;

headgear configured to maintain the cushion module in position on the patient'"'"'s head in use;

a rotatable elbow configured to receive the supply of air at positive pressure and deliver the supply of air at positive pressure to the breathing chamber through the circular frame opening; and

a shroud removably connected to the cushion module, the shroud comprising;

a vent-receiving opening that receives the vent arrangement, the vent-receiving opening being bounded by a rim, a lower portion of the rim being adjacent to the lower wall, and lateral portions of the rim being adjacent to corresponding ones of the two lateral side walls when the shroud is connected to the cushion module;

a circular elbow opening, the elbow extending into the elbow opening;

a rear surface that at least partly covers the external surface of the frame;

a pair of upper headgear connectors structured to connect to the headgear; and

a pair of lower headgear connectors structured to connect to the headgear via clips,

wherein the shroud, including the pair of upper headgear connectors and the pair of lower headgear connectors, is constructed from a single piece of a second material, the second material being harder than the elastomeric material, the shroud being more rigid than the cushion, and

wherein the shroud is connected to the cushion module so as to resist adjustable, rotational movement between the frame and the shroud about the longitudinal axis,

wherein the cylindrical collar includes a plurality of protrusions that protrude radially therefrom, and the plurality of protrusions are spaced circumferentially from one another about the cylindrical collar,

wherein the shroud includes a plurality of snap fingers circumferentially spaced about the elbow opening, and the plurality of snap fingers projecting from the rear surface of the shroud, and

wherein, to removably connect the shroud and the cushion module, the plurality of snap fingers are structured to resiliently deflect in a radial direction relative to the longitudinal axis of the cylindrical collar to form a removable snap-fit connection with the plurality of protrusions by moving the cushion module and the shroud towards one another along the longitudinal axis of the cylindrical collar.

2. The mask system of claim 1, wherein the cushion is constructed to engage the patient'"'"'s face along a nasal bridge region, a cheek region, and a lower lip/chin region of the patient'"'"'s face when in use, and

wherein the elbow includes an anti-asphyxia valve.

3. The mask system of claim 1, wherein the elastomeric material is silicone and the first material is polycarbonate.

4. The mask system of claim 1, wherein the one piece, integrated component is constructed and arranged such that the cushion and the frame are in an interlocking relationship with one another.

5. The mask system of claim 1, wherein the cushion includes notches and/or protrusions to engage with complementary features in the frame.

6. The mask system of claim 1, wherein the shroud comprises a forehead support.

7. The mask system of claim 1, wherein the vent-wall is oriented relative to the circular frame opening such that a longitudinal axis of each of the plurality of holes and the longitudinal axis of the cylindrical collar are not parallel.

8. The mask system of claim 1, wherein the elbow is sealingly attached to the shroud at the elbow opening, and

wherein the elbow is rotatable 360°

relative to the shroud.

9. The mask system of claim 1, wherein the shroud has a thickness at the rim such that the rim does not extend beyond the vent-wall when the shroud is removably connected to the cushion module.

10. A system for treating sleep disordered breathing, comprising:

the mask system of claim 1;

a flow generator to generate a supply of air at positive pressure to be delivered to the mask system; and

an air delivery tube configured to deliver the supply of air from the flow generator to the mask system.

11. The mask system of claim 1, wherein:

the cushion is constructed to engage the patient'"'"'s face along a nasal bridge region, a cheek region, and a lower lip/chin region of the patient'"'"'s face when in use,

the elastomeric material is silicone,

the one piece, integrated component is constructed and arranged such that the cushion and the frame are in an interlocking relationship with one another,

the first material is polycarbonate,

the second material is polycarbonate,

the headgear comprises hook and loop material,

the shroud further comprises a forehead support,

the elbow includes an anti-asphyxia valve,

the shroud has a thickness at the rim such that the rim does not extend beyond the vent-wall when the shroud is removably connected to the cushion module,

the elbow and the shroud are configured to be directly connected to one another, and

a region of the cushion positioned to engage the nasal bridge region of the patient is configured to allow increased movement compared to another region of the cushion that is adapted to seal with another region of the patient'"'"'s face.

12. The mask system of claim 11, wherein the plurality of protrusions and the plurality of snap fingers are arranged to remain stationary relative to one another as the elbow is rotated.

13. The mask system of claim 1, wherein each of the plurality of snap fingers and each of the plurality of protrusions have a part-annular shape that is curved relative to the longitudinal axis of the cylindrical collar, and

wherein the mask system is constructed so that the removable snap-fit connection is established when a force is applied to move the shroud and cushion module toward one another along the longitudinal axis until a rear end of each of the snap fingers initially contacts a front end of a corresponding one of the plurality of protrusions on the cylindrical collar, whereupon further application of the force causes each of the snap fingers to ride over the corresponding one of the plurality of protrusions and therefore resiliently deflect in a first radial direction, and upon further movement towards one another, each of the snap fingers resiliently moves in a second radial direction, opposite the first radial direction, and engages a rear end of the corresponding one of the plurality of protrusions to snap each of the snap fingers into place, thereby removably connecting the shroud and the cushion module.

14. A mask system to provide positive air pressure therapy to a patient, the mask system comprising:

a cushion module comprising a frame and a cushion;

the frame comprising;

an interior surface that at least partly forms a breathing chamber and an exterior surface opposite the interior surface;

a circular frame opening configured to receive a supply of air at positive pressure;

a cylindrical collar surrounding the frame opening and projecting from the frame, the cylindrical collar having a longitudinal axis; and

a vent arrangement including a vent-wall, a lower wall, and two lateral side walls, the vent-wall having a plurality of holes for gas washout from the breathing chamber to atmosphere, the vent-wall being spaced from the exterior surface of the frame by the lower wall and the two lateral side walls, and the vent arrangement being positioned on the frame such that the vent arrangement is superior to the frame opening in use, wherein the frame, including the vent arrangement and the cylindrical collar, is constructed from a first material, and

the cushion being constructed of an elastomeric material that is a different material from the first material, the first material being harder than the elastomeric material, the frame being more rigid than the cushion, the cushion configured to seal against the patient'"'"'s face in use to enable the supply of air at positive pressure to be delivered to at least the patient'"'"'s nose, wherein the cushion and the frame are joined to form a one-piece, integrated component;

a rotatable elbow configured to receive the supply of air at positive pressure and deliver the supply of air at positive pressure to the breathing chamber;

headgear configured to maintain the cushion module in position on the patient'"'"'s head in use;

a shroud configured to removably connect to the frame of the cushion module, the shroud comprising;

a vent-receiving opening that receives the vent arrangement, the vent-receiving opening being bounded by a rim, a lower portion of the rim being adjacent to the lower wall, and lateral portions of the rim being adjacent to corresponding ones of the two lateral side walls when the shroud is connected to the cushion module;

a circular elbow opening that accommodates the elbow;

a rear surface that at least partly covers the exterior surface of the frame;

a pair of upper headgear connectors structured to connect to said headgear; and

a pair of lower headgear connectors structured to connect to said headgear via clips,

wherein the shroud, including the pair of upper headgear connectors and the pair of lower headgear connectors, is constructed from a single piece of a second material, the second material being harder than the elastomeric material, the shroud being more rigid than the cushion, and

wherein the shroud and the frame are configured to be joined by a removable snap-fit connection, and

wherein the shroud is connected to the cushion module so as to resist adjustable, rotational movement between the frame and the shroud about the longitudinal axis of the cylindrical collar,

wherein the cushion is constructed to engage the patient'"'"'s face along a nasal bridge region, a cheek region, and a lower lip/chin region of the patient'"'"'s face when in use,

the elastomeric material is silicone,

the one-piece, integrated component is constructed and arranged such that the cushion and the frame are in an interlocking relationship with one another,

the first material is polycarbonate,

the second material is polycarbonate,

the headgear comprises hook and loop material,

the shroud further comprises a forehead support,

the elbow is directly attached to the shroud at the elbow opening,

the elbow includes an anti-asphyxia valve, and

a region of the cushion positioned to engage the nasal bridge region of the patient is configured to allow increased movement compared to another region of the cushion that is adapted to seal with another region of the patient'"'"'s face,

wherein the cylindrical collar includes a plurality of part-annular protrusions radially extending from the cylindrical collar, and the part-annular protrusions have a curvature centered about the longitudinal axis of the cylindrical collar,

wherein the shroud includes a plurality of part-annular snap fingers circumferentially spaced from one another and centered about a longitudinal axis of the elbow opening, the plurality of part-annular snap fingers extending rearward from the rear surface and being spaced circumferentially about the elbow opening of the shroud,

wherein the axis of the elbow opening and the axis of the cylindrical collar are coincident when the shroud and the frame are joined,

wherein the mask system is constructed so that the removable snap-fit connection is established when a force is applied to move the shroud and cushion module toward one another along the longitudinal axes of the elbow opening and the cylindrical collar until a rear end of each of the part-annular snap fingers initially contacts a front end of a corresponding one of the plurality of part-annular protrusions on the cylindrical collar, whereupon further application of the force causes each of the part-annular snap fingers to ride over the corresponding one of the plurality of part-annular protrusions and therefore resiliently deflect in a first radial direction, and upon further movement of the shroud and the cushion module towards one another, each of the part-annular snap fingers resiliently moves in a second radial direction, opposite the first radial direction, and engages a rear end of the corresponding one of the plurality of part-annular protrusions to snap each of the part-annular snap fingers into place, thereby removably connecting the shroud and the cushion module,

wherein, when the cylindrical collar and the plurality of part-annular snap fingers are joined to form the removable snap-fit connection, the cushion module and the shroud are stabilized against rotation relative to one another, and

wherein, once the removable snap-fit connection has been established, the part-annular snap fingers and the part-annular protrusions remain stationary relative to one another as the elbow is rotated.

15. The mask system of claim 14, wherein the cushion includes notches and/or protrusions to engage with complementary features in the frame.

16. The mask system of claim 14, wherein the vent-wall is oriented at an angle relative to the frame opening such that a longitudinal axis of each of the plurality of holes and the longitudinal axis of the cylindrical collar are not parallel.

17. The mask system of claim 14, wherein the elbow is sealingly attached to the shroud at the elbow opening, and

wherein the elbow is rotatable 360°

relative to the shroud.

18. The mask system of claim 14, wherein the shroud has a thickness at the rim such that the rim does not extend beyond the vent-wall when the shroud is removably connected to the cushion module.

19. A system for treating sleep disordered breathing, comprising:

the mask system of claim 14;

a flow generator to generate a supply of air at positive pressure to be delivered to the mask system; and

an air delivery tube configured to deliver the supply of air from the flow generator to the mask system.

20. A mask system to provide positive air pressure therapy to a patient, the mask system comprising:

a cushion module comprising;

a frame comprising an interior surface that at least partly forms a breathing chamber and an exterior surface opposite the interior surface;

a circular frame opening configured to receive a supply of air at positive pressure, the frame opening having a longitudinal axis; and

a circular member projecting from the exterior surface, the circular member being centered about the longitudinal axis and surrounding the frame opening;

a vent arrangement including a vent-wall and two lateral side walls, the vent-wall having 20-50 holes for gas washout from the breathing chamber to atmosphere, the vent-wall projecting from the exterior surface of the frame by the two lateral side walls, and the vent arrangement positioned on the frame such that the vent arrangement is superior to the frame opening in use,

wherein the vent arrangement and the circular member are constructed from a first material, and

a cushion constructed of an elastomeric material that is a different material from the first material, the first material being harder than the elastomeric material, the frame being more rigid than the cushion, wherein the cushion is constructed to seal against the patient'"'"'s face along a nasal bridge region, a cheek region, and a lower lip/chin region of the patient'"'"'s face when in use to enable the supply of air at positive pressure to be delivered to the patient'"'"'s nose and mouth,

an elbow configured to receive the supply of air at positive pressure and deliver the supply of air at positive pressure to the breathing chamber, wherein the elbow includes an anti-asphyxia valve;

headgear configured to maintain the cushion module in position on the patient'"'"'s head in use;

a shroud configured to removably connect to the frame of the cushion module, the shroud comprising;

a vent-receiving opening that receives the vent arrangement, the vent-receiving opening being bounded by a rim of closed shape that is complementary to a shape of the vent arrangement, lateral portions of the rim being adjacent to corresponding ones of the two lateral side walls when the shroud is connected to the cushion module;

an elbow opening of closed shape that accommodates the elbow;

a rear surface that at least partly covers the exterior surface of the frame;

a pair of upper headgear connectors structured to connect to said headgear; and

a pair of lower headgear connectors structured to connect to said headgear via clips,

wherein the pair of upper headgear connectors and the pair of lower headgear connectors are constructed from a single piece of a second material, the second material being harder than the elastomeric material, the shroud being more rigid than the cushion,

wherein the shroud and the frame are configured to be joined by a removable snap-fit connection, and

wherein the shroud is connected to the cushion module so as to resist adjustable, rotational movement between the frame and the shroud about the longitudinal axis,

wherein the elastomeric material is silicone and the first material is polycarbonate,

wherein the cushion and the frame are connected via a tongue and groove arrangement including a tongue of the cushion that fits within a groove along a perimeter of the frame, the tongue including a lip adapted to interlock with a bead within the groove of the frame,

wherein the cushion and the frame include positioning features to assist with proper alignment of the cushion with the frame, the cushion having a pair of lower rounded corners and a top apex, each of the lower rounded corners including a notch to mate with a protrusion of the frame, and the apex including a top protrusion to mate with a complementary feature in the frame, when the cushion and the frame are attached to one another by inserting the tongue into the groove, each said notch of the cushion being positioned on the tongue and each said protrusion of the frame being positioned within the groove,

wherein the vent-wall is oriented at an angle relative to the frame opening such that a longitudinal axis of each of the holes and the longitudinal axis of the frame opening are not parallel,

wherein the elbow is attached to the frame and is rotatable 360°

relative to the frame,

wherein the headgear comprises hook and loop material, and

wherein the mask system includes an upper retaining mechanism to help retain the shroud and the cushion module, the upper retaining mechanism including a pair of opposing platforms provided on an upper part of the frame, each platform including a first slot, each platform being spaced from the exterior surface of the frame to at least partly define a second slot, the upper retaining mechanism including a tang protrusion provided on an upper part of the rear surface of the shroud, each tang protrusion including a first tang to be received in the first slot and a second tang to be received in the second slot when the shroud and the cushion module are attached to one another.

21. The mask system of claim 20, wherein:

the circular member of the frame includes at least two radial protrusions,

the shroud includes a plurality of part-annular snap connection portions circumferentially spaced from one another and centered about a longitudinal axis of the elbow opening,

wherein, to releasably connect the shroud to the cushion module, the plurality of part-annular snap connection portions are structured to resiliently move to form the removable snap-fit connection between the at least two radial protrusions and the plurality of part-annular snap connection portions by moving the cushion module and the shroud towards one another, and

wherein, when the at least two radial protrusions and the plurality of part-annular snap connection portions are joined to form the removable snap-fit connection, the cushion module and the shroud are stabilized against rotation relative to one another,

wherein the radial protrusions and the part-annular snap connection portions remain stationary relative to one another while the elbow is rotated, and

wherein each of the pair of upper headgear connectors includes an elongated arm with a free end including a slot to receive an upper strap of the headgear, each said elongated arm being at least partly covered with an elastic sleeve positioned proximate the patient'"'"'s cheek in use.

22. A system for treating sleep disordered breathing, comprising:

the mask system of claim 20;

a flow generator to generate a supply of air at positive pressure to be delivered to the mask system; and

an air delivery tube configured to deliver the supply of air from the flow generator to the mask system.

23. The mask system of claim 20, wherein each of the upper headgear connectors includes an arm at least partly covered by a fabric or elastic sleeve.

24. A mask system to provide positive air pressure therapy to a patient, the mask system comprising:

a cushion module comprising a frame and a cushion;

the frame comprising;

an interior surface that at least partly forms a breathing chamber and an exterior surface opposite the interior surface;

a circular frame opening configured to receive a supply of air at positive pressure;

a cylindrical collar surrounding the frame opening and projecting from the frame, the cylindrical collar having a longitudinal axis; and

a plurality of part-annular protrusions radially extending from the cylindrical collar, each said part-annular protrusion having a curvature centered about the longitudinal axis of the cylindrical collar,

wherein the frame, including the cylindrical collar and the part-annular protrusions, is constructed from a first piece of polycarbonate, and

the cushion being constructed of elastomeric silicone, the first piece of polycarbonate being harder than the elastomeric silicone, the frame being more rigid than the cushion, the cushion configured to seal against the patient'"'"'s face in use to enable the supply of air at positive pressure to be delivered to at least the patient'"'"'s nose,

wherein the cushion and the frame are joined to form a one-piece, integrated component;

a rotatable elbow configured to receive the supply of air at positive pressure and deliver the supply of air at positive pressure to the breathing chamber;

headgear configured to maintain the cushion module in position on the patient'"'"'s head in use;

a shroud configured to removably connect to the frame of the cushion module, the shroud comprising;

a circular elbow opening that accommodates the elbow;

a rear surface that at least partly covers the exterior surface of the frame;

at least a first pair of headgear connectors structured to connect to said headgear, a plurality of part-annular snap fingers each having a curvature centered about a longitudinal axis of the elbow opening, each said part-annular snap finger extending rearward from the rear surface and being positioned about the elbow opening of the shroud,

wherein the shroud, including the pair of headgear connectors and the plurality of part-annular snap fingers, is constructed from a second piece of polycarbonate, the second piece of polycarbonate being harder than the elastomeric silicone, the shroud being more rigid than the cushion, and

wherein the shroud and the frame are configured to be joined by a removable snap-fit connection,

wherein the shroud is connected to the cushion module so as to resist adjustable, rotational movement between the frame and the shroud about the longitudinal axis,

wherein the headgear comprises hook and loop material,

wherein the elbow is directly attached to the shroud at the elbow opening, and

wherein the mask system is constructed so that the removable snap-fit connection is established when a force is applied to move the shroud and cushion module toward one another along the longitudinal axes of the elbow opening and the cylindrical collar until a rear end of each said part-annular snap finger initially contacts a front end of a corresponding one of said part-annular protrusions on the cylindrical collar, whereupon further application of the force causes each said part-annular snap finger to ride over the corresponding part-annular protrusion and therefore resiliently deflect in a first radial direction relative to the longitudinal axis, and upon further movement of the shroud and the cushion module towards one another, each said part-annular snap finger resiliently moves in a second radial direction, opposite the first radial direction, and engages a rear end of the corresponding part-annular protrusion to snap each said part-annular snap finger into place, thereby removably connecting the shroud and the cushion module, and

wherein, once the removable snap-fit connection has been established, the part-annular snap fingers and the part-annular protrusions remain stationary relative to one another even if the elbow is rotated in use.

25. The mask system of claim 24, further comprising at least one tab and recess arrangement positioned circumferentially adjacent the part-annular snap fingers and the part-annular protrusions, the tab and recess arrangement including a tab that fits within a recess to help to resist rotation of the collar relative to the shroud upon establishing the snap-fit connection between the shroud and the cushion module.

26. The mask system of claim 25, wherein the tab and recess arrangement is located circumferentially between mating ones of the part-annular protrusions and the part-annular snap fingers.

27. The mask system of claim 24, wherein the shroud further includes a second pair of headgear connectors structured to connect to said headgear, the headgear including a pair of upper straps to connect to the first pair of headgear connectors and a pair of lower straps to connect to the second pair of headgear connectors via clips.

28. The mask system of claim 24,

wherein the frame includes a vent arrangement including a vent-wall, a lower wall, and two lateral side walls, the vent-wall having a plurality of holes for gas washout from the breathing chamber to atmosphere, the vent-wall being spaced from the exterior surface of the frame by the lower wall and the two lateral side walls, the vent arrangement being positioned on the frame such that the vent arrangement is superior to the frame opening in use,

wherein the shroud includes a vent-receiving opening that receives the vent arrangement, the vent-receiving opening being bounded by a rim, a lower portion of the rim being adjacent to the lower wall, and lateral portions of the rim being adjacent to corresponding ones of the two lateral side walls when the shroud is connected to the cushion module, and

wherein the vent-wall is oriented at an angle relative to the frame opening such that a longitudinal axis of each of the plurality of holes and the longitudinal axis of the cylindrical collar are not parallel,

wherein the shroud has a thickness at the rim such that the rim does not extend beyond the vent-wall when the shroud is removably connected to the cushion module,

wherein the cushion includes notches and/or protrusions to engage with complementary features in the frame, and

wherein the elbow is rotatable 360°

relative to the shroud.

29. A system for treating sleep disordered breathing, comprising:

the mask system of claim 24;

a flow generator to generate a supply of air at positive pressure to be delivered to the mask system; and

an air delivery tube configured to deliver the supply of air from the flow generator to the mask system.