# US 10,307,554 B2 · Mask and components thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,554 B2 - Document ID: US10307554B2 - Status: Granted - Kind: B2 - Application number: 12/461,448 - Filed: 2009-08-12 - Published: 2010-01-07 - Granted: 2019-06-04 - Earliest claimed: 2002-11-06 - Assignees: ResMed Limited - Applicants: Michael Berthon-Jones; Peter Edward Bateman; Donald Darkin; Robin Garth Hitchcock; Philip James Jenkinson; Susan Robyn Lynch; Gordon Joseph Malouf; Patrick John McAuliffe; Milind Chandrakant Raje; Gary Christopher Robinson; Richard Sokolov; Philip Thomas Stallard; Michael Kassipillai Gunaratnam - Inventors: Michael Berthon-Jones; Peter Edward Bateman; Donald Darkin; Robin Garth Hitchcock; Philip James Jenkinson; Susan Robyn Lynch; Gordon Joseph Malouf; Patrick John McAuliffe; Milind Chandrakant Raje; Gary Christopher Robinson; Richard Sokolov; Philip Thomas Stallard; Michael Kassipillai Gunaratnam - Web page: https://patentgrep.com/patent/US10307554B2 ## CPC - A61M 16/0683: {Holding devices therefor} - A61M 16/0003: {Accessories therefor, e.g. sensors, vibrators, negative pressure} - A61M 16/0051: {with alarm devices} - A61M 16/0057: {Pumps therefor} - A61M 16/022: {Control means therefor} - A61M 16/06: Respiratory or anaesthetic masks - A61M 16/0605: {Means for improving the adaptation of the mask to the patient} - 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 16/0633: {with forehead support} - A61M 16/0875: {Connecting tubes} - A61M 16/0825: {with ball-sockets} - A61M 16/20: Valves specially adapted to medical respiratory devices - A61M 2016/0027: {pressure meter} - A61M 2016/0661: {with customised shape} - A61M 2205/0266: Shape memory materials - A61M 2205/10: with powered movement mechanisms - A61M 2205/15: Detection of leaks - A61M 2205/3344: Measuring or controlling pressure at the body treatment site - 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 comfortable low-leak mask assembly for use with Non-Invasive Positive Pressure Ventilation (NIPPV) is provided to improve patient compliance and/or treatment. The mask system may include headgear having straps that are substantially inextensible and/or micro-adjustable; and/or a mask and/or cushion that includes various structures to allow enhanced/tailored sealing and/or fit at selected locations on the patient's face. ## Claims ### Claim 1 A cushion for non-invasive positive pressure ventilation mask, the cushion comprising: a flexible element including foam; and a cushion flange joined to the flexible element, wherein said cushion flange includes a receptacle adapted to releasably receive a portion of a frame of the mask, the receptacle facing away from the flexible element, and the entirety of the flexible element is more flexible than the cushion flange, wherein a surface of the flexible element constitutes a front surface of the cushion and a mask-engaging surface of the cushion flange constitutes a rear surface of the cushion, wherein the cushion extends from the front surface to the rear surface, and wherein the flexible element is joined to more than one surface of the cushion flange. ### Claim 2 (depends on 1) The cushion of claim 1, wherein the cushion flange is rigid. ### Claim 3 (depends on 1) A cushion according to claim 1, wherein the flexible element is joined to a front surface of the cushion flange that opposes the mask-engaging surface of the cushion flange. ### Claim 4 (depends on 3) A cushion according to claim 3, wherein a flexibility of the cushion increases from the mask-engaging surface to the front surface. ### Claim 5 (depends on 1) A non-invasive positive pressure ventilation mask comprising: a frame; and a cushion according to claim 1. ### Claim 6 A cushion assembly for a mask used for treatment of sleep disordered breathing, the cushion assembly comprising: a first layer including a) a front side with a receptacle adapted to receive a portion of a frame of the mask and b) a rear side opposite the front side, the receptacle facing away from the rear side; and a second layer constructed of a foam material and being fixed to the rear side of the first layer, the second layer defining a cushion shape and including a first surface adapted to engage a wearer's face and form a seal between the mask and the wearer's face upon engagement and compress upon application of a force to the cushion assembly, wherein the second layer is molded to the first layer. ### Claim 7 (depends on 6) A cushion assembly according to claim 6, wherein the second layer includes a skin. ### Claim 8 (depends on 7) A cushion assembly according to claim 7, wherein the skin is formed of a silicone. ### Claim 9 (depends on 6) The cushion assembly according to claim 6, wherein the foam material is at least partially made from a viscoelastic foam. ### Claim 10 (depends on 9) The cushion assembly according to claim 9, wherein the foam material includes multiple densities of foam material. ### Claim 11 (depends on 6) The cushion assembly according to claim 6, wherein the foam material is constructed from an open cell foam or a closed cell foam. ### Claim 12 (depends on 6) The cushion assembly according to claim 6, wherein the foam material includes one or more of a neoprene foam, a latex foam or a urethane foam. ### Claim 13 (depends on 6) The cushion assembly according to claim 6, wherein the first layer includes a second surface adapted to engage the frame of the mask. ### Claim 14 (depends on 13) The cushion assembly according to claim 13, wherein the second surface includes a shoulder to engage the frame of the mask. ### Claim 15 (depends on 14) The cushion assembly according to claim 14, wherein the shoulder includes a groove adapted to engage one or more surfaces of the frame of the mask. ### Claim 16 (depends on 15) The cushion assembly according to claim 15 wherein the one or more surfaces of the frame include one or more edges. ### Claim 17 (depends on 6) The cushion assembly according to claim 6, wherein a density of the foam material is in a range of 1 to 4 pounds per cubic foot. ### Claim 18 (depends on 6) The cushion assembly according to claim 6, wherein the first layer is constructed of an elastomer material. ### Claim 19 (depends on 6) The cushion assembly according to claim 6, wherein the second layer includes a region that extends beyond the first layer. ### Claim 20 (depends on 6) A cushion assembly according to claim 6, wherein the second layer includes no skin. ### Claim 21 (depends on 6) A cushion assembly according to claim 6, wherein the first layer is more rigid than the second layer. ### Claim 22 (depends on 6) A cushion assembly according to claim 6, wherein the first layer includes no foam material. ### Claim 23 (depends on 6) A cushion assembly according to claim 6, wherein the first layer provides a support structure for the second layer. ### Claim 24 (depends on 6) A cushion assembly according to claim 6, wherein the first layer is adapted to compress upon application of a force from the second layer. ### Claim 25 (depends on 6) A cushion assembly according to claim 6, wherein the first layer and the second layer form a subassembly adapted to be connected to the frame of the mask. ### Claim 26 (depends on 6) A cushion assembly according to claim 6, wherein the first layer is structured to connect to the frame with a snap-fit. ### Claim 27 (depends on 6) A mask assembly, comprising: a frame; and a cushion assembly according to claim 6. ### Claim 28 (depends on 6) A cushion according to claim 6, wherein the second layer is positioned so that when a force is applied to the first surface, the second layer compresses against the first layer. ### Claim 29 (depends on 6) A cushion assembly according to claim 6, wherein the cushion assembly is configured so that at least a portion of the second layer is sandwiched between the first layer and the wearer's face when the first layer is connected to the mask frame and the mask is engaged with the wearer's face.