# US 11,439,783 B2 · Cushion for patient interface device, breathing mask with cushion, and method and apparatus for same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,783 B2 - Document ID: US11439783B2 - Status: Granted - Kind: B2 - Application number: 15/276,770 - Filed: 2016-09-26 - Published: 2017-02-23 - Granted: 2022-09-13 - Earliest claimed: 2014-03-26 - Applicants: Michael P Ellis - Inventors: Michael P Ellis - Web page: https://patentgrep.com/patent/US11439783B2 ## CPC - A61M 16/0622: {having an underlying cushion} - A61M 16/0057: {Pumps therefor} - A61M 16/06: Respiratory or anaesthetic masks - 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)} - B29C 51/082: {by shaping between complementary mould parts} - B29C 51/14: using multilayered preforms or sheets - B29C 51/32: having cutting means - B29C 70/345: {using matched moulds} - B32B 3/266: {characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12} - B32B 3/28: characterised by a layer comprising a deformed thin sheet {, i.e. the layer having its entire thickness deformed out of the plane}, e.g. corrugated, crumpled (B32B29/08 takes precedence) - B32B 5/024: {Woven fabric} - B32B 5/026: {Knitted fabric} - B32B 5/04: characterised by a layer being specifically extensible by reason of its structure or arrangement {, e.g. by reason of the chemical nature of the fibres or filaments} - B32B 5/22: characterised by the presence of two or more layers which {are next to each other and are fibrous, filamentary, formed of particles or foamed (layer formed of natural mineral fibres or particles next to a foam layer B32B19/047, next to a layer made of particles B32B19/048, or next to a fibrous or filamentary layer B32B19/06; paper layer or cardboard layer next to a paper layer or cardboard layer B32B29/005, next to a foam layer B32B29/007, next to a fibrous or filamentary layer B32B29/02, or next to a particulate layer B32B29/04)} - B32B 5/26: another layer {next to it} also being fibrous or filamentary {(relative arrangement of fibres or filaments of different layers B32B5/12)} - B32B 25/042: {of natural rubber or synthetic rubber} - B32B 25/10: next to a fibrous or filamentary layer - B32B 25/20: comprising silicone rubber - A61M 16/0616: {with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure} - A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking - A61M 2205/7536: allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes - A61M 2207/10: Device therefor - B29K 2083/00: Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material - B29K 2105/256: {Sheets, plates, blanks or films} - B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)} - B32B 2274/00: Thermoplastic elastomer material - B32B 2307/546: Flexural strength; Flexion stiffness - B32B 2307/56: Damping, energy absorption - B32B 2307/7246: Water vapor barrier - B32B 2307/7265: Non-permeable - B32B 2307/744: Non-slip, anti-slip - B32B 2535/00: Medical equipment, e.g. bandage, prostheses or catheter - 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)} - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM - B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS - B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES ## Abstract A patient interface device and cushion for the device are respectively disclosed, for preferred CPAP and BiPAP breathing masks. The cushion has a composite structure with an open rounded polygonal profile defining a mask side layer and a slip-resistant fibrous patient side layer, with an intermediate barrier layer positioned between the first and second layers. The layers are integrally bonded together into a three-dimensional conformation defining a J-shaped cross section and an inboard patient side curl opening into an air chamber juxtaposed with one or more of the patient's airways. The body exhibits flexibility between about 4 and about 10 Taber Stiffness Units. Method and apparatus for making the cushion are further described. ## Claims ### Claim 1 A cushion for a patient breathing mask interface device, the cushion comprising: an open body formed into a three-dimensional J-shaped cross section with an interface coupling front portion and a patient contacting back portion, the back portion defining an inboard curl leading into a dampening chamber in fluid communication with a source of a dampening medium, the chamber being juxtaposed with one or more of the patient's airways, wherein the patient contacting portion has a fibrous, slip-resistant surface and an integral fluid impermeable barrier stretch-bonded together into a substantially shape-retaining and dimensionally stable construction. ### Claim 2 (depends on 1) The cushion of claim 1 wherein the body exhibits flexibility between about 4 to about 10 Taber Stiffness Units. ### Claim 3 (depends on 1) The cushion of claim 1 wherein the fibrous, slip resistant surface further comprises a fibrous layer and a sealing layer stretch-bonded together into a laminar composite. ### Claim 4 (depends on 1) The cushion of claim 1 wherein the body further comprises a nosepiece having an open, generally triangular profile with the inboard curl surrounding the nose of the patient. ### Claim 5 (depends on 1) The cushion of claim 1 wherein the body further comprises a nose pillows. ### Claim 6 (depends on 1) The cushion of claim 1 further comprising a full face cushion wherein the body defines an open generally triangular profile with the inboard curl surrounding the nose and mouth of the patient. ### Claim 7 (depends on 1) The cushion of claim 1 wherein the fibrous, slip-resistant surface further comprises a woven puffy fabric. ### Claim 8 (depends on 1) The cushion of claim 1 wherein the fluid impermeable barrier further comprises an elastomeric sealing layer. ### Claim 9 (depends on 7) The cushion of claim 7 wherein the body further comprises a plurality of woven fabric layers and one or more sealant layers. ### Claim 10 (depends on 1) The cushion of claim 1 wherein the fibrous surface and fluid impermeable barrier further comprise a stretch-bonded laminar molded composite. ### Claim 11 A cushion for a patient breathing mask interface, comprising: a first fibrous mask side layer; a second slip-resistant fibrous facial side layer, superposed on the first layer; a third, fluid barrier layer interposed between the first and second layers, the layers having a generally polygonal shape; and wherein the layers are integrally bonded together into a laminar composite defining a form-fitting, generally self-adjusting three-dimensional body having a J-shaped cross section including an inboard curl defining a patient-engaging portion and an interface-engaging portion, the curl opening into a dampening chamber juxtaposed with one or more of the patient's airways and communicating with a pressurized source of a dampening medium delivered to the chamber, the laminar composite is stretch-bonded together into a substantially shape-retaining and dimensionally-stable construction. ### Claim 12 (depends on 11) The cushion of claim 11 wherein either of the first fibrous mask side layer and second slip-resistant facial side layer is a woven fabric. ### Claim 13 (depends on 12) The cushion of claim 12 wherein either of the first fibrous mask side layer and second slip-resistant facial side layer is a fleeced fabric having a knit surface and a puffy brushed body-side surface. ### Claim 14 (depends on 12) The cushion of claim 12 wherein the first fibrous mask side layer is a fleeced fabric and the third layer is an elastomeric sealant, the composite further comprising a stretch-bonded laminate. ### Claim 15 (depends on 14) The cushion of claim 14 wherein the knit surface of the first fibrous mask side layer is in contact with the third fluid barrier layer. ### Claim 16 (depends on 14) The cushion of claim 14 wherein the puffy surface of the first layer is in contact with the patient's face. ### Claim 17 (depends on 12) The cushion of claim 12 wherein the second slip-resistant facial side layer is a fleeced fabric. ### Claim 18 (depends on 17) The cushion of claim 17 wherein the second slip-resistant facial side layer has a puffy brushed surface. ### Claim 19 (depends on 18) The cushion of claim 18 wherein the knit surface of the second slip-resistant facial side layer is in contact with the third fluid barrier layer. ### Claim 20 (depends on 11) The cushion of claim 11 wherein both of the first and second layers are a woven fabric. ### Claim 21 (depends on 11) The cushion of claim 11 wherein the first fibrous mask side layer and second slip-resistant facial side layer are each a fleeced fabric having a knit surface and a puffy brushed surface, with the knit surfaces of each layer being in contact with the third, fluid barrier layer. ### Claim 22 (depends on 11) The cushion of claim 11 wherein the cushion is part of a nosepiece for a Continuous Positive Air Pressure mask, which covers the nasal airway of the patient. ### Claim 23 (depends on 11) The cushion of claim 11 wherein the cushion covers airways of both the nose and mouth of the patient. ### Claim 24 (depends on 11) The cushion of claim 11 wherein the cushion covers the nasal airway of the patient. ### Claim 25 (depends on 11) The cushion of claim 11, adapted for a Continuous Positive Air Pressure patient mask interface, the barrier further comprising an elastomeric sealing third, fluid barrier layer, wherein the laminar composite body has a form-fitting, generally self-adjusting three-dimensional shape defining an air chamber communicating with a pressurized air source, the inboard curl opening into the chamber adjacent one of the patient's airways, and wherein the laminar composite is stretch-bonded together into a substantially shape-retaining construction. ### Claim 26 (depends on 11) The cushion of claim 11 further comprising patient nose pillows for a Continuous Positive Air Pressure mask interface. ### Claim 27 A method of making a cushion blank for a patient breathing mask interface, the method comprising the steps of: (a) providing a mold set having a first platen with a generally annular protruding wall including inner and outer surfaces terminating in a common lip and a juxtaposed second platen including a corresponding generally annular groove, the lip and groove together confining a mold space as the platens are moved relative to one another; (b) providing a stretchable laminar composite sheet having a fibrous surface and a fluid impermeable barrier; (c) providing a means for retaining the sheet of (b) in fixed position between the lip and groove; (d) relatively moving the platens and entrapping the sheet in tension within the mold space as the mold set is closed; and (e) opening the mold set and removing a three-dimensional form-fitting, generally self-adjusting cushion blank having a curled lip, the composite sheet of the blank exhibiting a Taber Stiffness value between about 4 to about 10 Taber Stiffness Units. ### Claim 28 (depends on 27) The method of claim 27 further comprising the step of: providing a woven second layer of step (b), including a knit surface and an opposite puffy brushed surface. ### Claim 29 (depends on 28) The method of claim 28 further comprising the step of: applying an elastomeric sealing layer of step (c) to the knit surface of the second layer. ### Claim 30 (depends on 28) The method of claim 28 further comprising the step of: providing a woven first layer of step (c) including a knit surface and an opposite puffy brushed surface. ### Claim 31 (depends on 30) The method of claim 30 further comprising the step of: applying the elastomer of step (c) to the knit side of each of the first and second fibrous layers. ### Claim 32 (depends on 31) The method of claim 31 further comprising the step of: applying a flowable, self-leveling silicone elastomer to either of the first and second layers. ### Claim 33 (depends on 31) The method of claim 31 further comprising the step of: applying a spreadable silicone elastomer paste to each of the first and second layers. ### Claim 34 (depends on 30) The method of claim 30 further comprising the step of: applying the elastomer of step (c) to the puffy brushed side of each of the first and second fibrous layers. ### Claim 35 (depends on 27) The method of claim 27 further comprising the step of: applying a flowable, self-leveling silicone elastomer to either of the first and second layers. ### Claim 36 (depends on 35) The method of claim 35 further comprising the step of: applying the flowable; self-leveling silicone elastomer to both of the first and second layers, respectively. ### Claim 37 (depends on 27) The method of claim 27 further comprising the step of: applying a spreadable silicone elastomer paste to at least one of the first and second layers. ### Claim 38 (depends on 37) The method of claim 37 further comprising the step of: applying a spreadable silicone elastomer paste to each of the first and second layers. ### Claim 39 (depends on 27) The method of claim 27 wherein the retaining means of steps (c) further comprises a tambour ring having an inner annular surface that slides over the sheet of step (b) and the outer surface of the wall of step (a) thereby stretching and entrapping the sheet in the mold space as the platens are relatively moved. ### Claim 40 An interface for a Continuous Positive Air Pressure mask having a contoured nose portion, the interface comprising: (a) a bracket mounted to the mask adjacent the nose portion; (b) a cushion supported by a flange articulating with the bracket, the cushion including (i) a first fibrous mask side layer, (ii) a second slip-resistant fibrous facial side layer, superposed on the first layer, and (iii) a third, elastomeric sealing layer interposed between the first and second layers, the layers having an open generally triangular shape; and (c) wherein the layers are stretch-bonded together into an integral laminar composite defining a form-fitting, generally self-adjusting open, dimensionally-constant triangular shaped body containing an air chamber juxtaposed with the patient's nasal airway and communicating with a pressurized air source, the body further having a J-shaped cross section including an inboard curl that engages the bridge of the patient's nose and facial curves, the body also including a contiguous outboard wall that terminates in a mask engaging rim, the laminar composite is stretch-bonded together into a substantially shape-retaining construction. ### Claim 41 (depends on 1) The cushion of claim 1 wherein the slip-resistant surface includes a single fibrous layer and a single film barrier layer stretch-bonded together to form the body.