Overmolded Textile Cushion

Abstract

To provide a cushion for a respiratory mask.SOLUTION: A cushion 114 includes a face contacting portion, a non-face contacting portion, and an intermediate region. The face contacting portion is formed from an open cell foam material and includes an opening 128 to provide, in use, a source of breathing gas to a user's airways. The non-face contacting portion is formed from an elastomeric material. The intermediate region is formed between the face contacting portion and the non-face contacting portion. Open cells of the open cell foam material in the intermediate region are filled with the elastomeric material.SELECTED DRAWING: Figure 2B

Description

Technical Field

[0001] The present disclosure generally relates to seals for respiratory interfaces, and interfaces comprising such seals and either a mask or both a mask and headgear. More particularly, certain aspects of the present disclosure relate to cushions having a textile portion and an elastomer portion.

Background Art

[0002] Respiratory interfaces are used to supply one or more respiratory gases, such as air, to a user under positive pressure in CPAP (or other positive pressure) therapy. The respiratory interface delivers the gas to the user's nose and mouth. The respiratory interface provides a substantially airtight seal against the user's face to deliver pressurized gas to the user through the respiratory interface.

Summary of the Invention

[0003] Preferably, the respiratory interface is configured to be soft, comfortable, lightweight, and have an aesthetic that harmonizes with the bedroom when worn by the user. The respiratory interface can be formed from multiple materials such that certain portions of the respiratory interface provide sufficient rigidity to prevent collapse due to over-tightening of the respiratory interface during wear. Other portions can provide a soft feel and an aesthetic appearance that harmonizes with the bedroom.

[0004] The systems, methods, and devices described herein have innovative aspects, none of which are essential or solely responsible for their desirable attributes without limiting the scope of the claims. Here, without limiting the scope of the claims, some advantageous features are outlined.

[0005] According to at least one of the embodiments disclosed herein, a cushion for a breathing mask is provided. The cushion comprises a face-contact portion comprising an open-cell foam material, the portion in contact with the face having an opening for providing a source of breathing gas to the user's airway during use; a non-face-contact portion comprising an elastomer material; and an intermediate region formed between the face-contact portion and the non-face-contact portion. The elastomer material of the non-face-contact portion is received by the open cells of the open-cell foam material in the intermediate region.

[0006] In a further embodiment, the intermediate region extends at least partially around the periphery of the cushion.

[0007] In a further embodiment, the intermediate region extends around the periphery of the cushion.

[0008] In a further embodiment, the intermediate region extends around the entire periphery of the cushion.

[0009] In a further embodiment, the portion that comes into contact with the face includes a mouth region and a nose region.

[0010] In a further embodiment, the nasal region is composed of an open-cell foam material.

[0011] In a further embodiment, the nose region is made of textile material.

[0012] In a further embodiment, the mouth area contains the same material as the part that does not come into contact with the face.

[0013] In a further embodiment, the intermediate region extends from the periphery to the opening along the portion that contacts the face.

[0014] In a further embodiment, the portion that comes into contact with the face includes a laminated material.

[0015] In a further embodiment, the open-cell foam material forms part of the foam and fabric laminate material.

[0016] According to at least one of the embodiments disclosed herein, a cushion for a breathing mask is provided. The cushion comprises a portion that comes into contact with the face, which includes a placement area for positioning the user's face relative to the mask and a sealing area for providing a seal to the user's face, and a portion that does not come into contact with the face. The sealing area surrounds the placement area, which comprises a textile material.

[0017] In a further embodiment, the sealing region includes an elastomer material.

[0018] In a further embodiment, the portion that does not come into contact with the face and the sealing area include the same material.

[0019] In a further embodiment, the material that does not come into contact with the face includes a silicone material.

[0020] In a further embodiment, the sealing region comprises a transition region extending between the sealing region and the placement region.

[0021] In a further embodiment, the transition region includes a composite material.

[0022] In a further embodiment, the transition region includes a textile material impregnated with an elastomer material in the sealing region.

[0023] In a further embodiment, the transition area and the sealing area are configured to form a seal against the user's face during use.

[0024] In a further embodiment, the placement area comprises a continuous breathable surface such that a supply of breathing gas can be provided to the user's airway through the placement area during use.

[0025] In a further embodiment, the placement area comprises a first opening configured to supply breathing gas to at least the patient's nose during use.

[0026] According to a further aspect, the first opening is a nasal opening configured to deliver the supply of breathing gas to the patient's nose.

[0027] According to a further aspect, the first opening is an oral-nasal opening configured to deliver the supply of breathing gas to the patient's mouth and nose.

[0028] According to a further aspect, the placement area further comprises an oral opening disposed below the nasal opening during use.

[0029] According to a further aspect, the textile material of the placement area comprises two or more layers.

[0030] According to a further aspect, the transition area is thicker than the placement area.

[0031] According to a further aspect, the transition area protrudes in the thickness direction towards the inside of the cushion.

[0032] According to a further aspect, the transition area protrudes from the inner surface of the portion that contacts the face, and the outer surface of the portion that contacts the face is a smooth continuous surface.

[0033] According to at least one of the embodiments disclosed herein, a cushion for a breathing mask is provided. The cushion comprises a face-contacting portion including a placement area for positioning the user's face relative to the mask and a seal area for providing a seal against the user's face, and a non-face-contacting portion including an elastomeric material. The placement area is formed from a textile material, and the textile material is configured to have a predetermined three-dimensional contour shape. The seal area is disposed around the placement area such that the seal area surrounds the placement area and at least partially defines the predetermined three-dimensional contour shape of the textile material.

[0034] According to a further aspect, the textile material is supported under tension by the seal area to form the predetermined three-dimensional contour shape of the textile material.

[0035] In a further embodiment, the textile material is stretchable along a single axis.

[0036] In a further embodiment, the textile material is stretchable along multiple axes.

[0037] In a further embodiment, the textile material is expandable and contractible along two axes.

[0038] In a further embodiment, the sealing region includes a composite material.

[0039] In a further embodiment, the composite material comprises an outer periphery of a stretchable textile material in a placement area, which is overmolded with the same elastomer material as the portion that does not come into contact with the face, so that the textile is impregnated with the elastomer material.

[0040] In a further embodiment, the cushion further comprises a stabilizing layer, the stabilizing layer including a layer of elastomer material supporting at least a portion of the placement area.

[0041] In a further embodiment, the stabilizing layer is positioned on the upper half of the part that comes into contact with the face and is configured to apply pressure to the patient's nose during use, thereby stabilizing the cushion on the patient's face.

[0042] In a further embodiment, the stabilizing layer extends across the bridge of the nose in the portion that comes into contact with the face.

[0043] In a further embodiment, the stabilizing layer is separated from the textile layer.

[0044] In a further embodiment, the stabilizing layer is placed on the bridge of the nose.

[0045] In a further embodiment, the stabilizing layer has an outer edge attached to the inner circumference of the sealing region and a free inner edge.

[0046] In a further embodiment, the stabilizing layer includes a pair of stabilizing layers that are positioned on either side of the user's nose during use.

[0047] In a further embodiment, the sealing area includes a composite material and extends into a portion that does not come into contact with the face.

[0048] According to at least one of the embodiments disclosed herein, a cushion for a breathing mask is provided. The cushion comprises a portion that contacts the face and a portion that does not contact the face. At least a portion of the portion that contacts the face comprises a permeable material, and the portion that does not contact the face comprises an elastomer material. The permeable material portion of the portion that contacts the face is bonded to the portion that does not contact the face by impregnating the elastomer material into at least a portion of the permeable material.

[0049] In a further embodiment, at least a portion of the part that comes into contact with the face is made of an elastomer material, and the permeable material portion of the part that comes into contact with the face is bonded to the part that does not come into contact with the face by impregnating the elastomer material portion of the part that comes into contact with the face into the permeable material.

[0050] In a further embodiment, the elastomer material portion that comes into contact with the face is integrated with the portion that does not come into contact with the face.

[0051] In a further embodiment, the portion that comes into contact with the face comprises a placement area and a sealing area, the sealing area surrounding the placement area, and the placement area incorporating the permeable material portion of the portion that comes into contact with the face.

[0052] In a further embodiment, the portion that comes into contact with the face comprises a placement area and a sealing area, the sealing area surrounding the placement area, and the sealing area incorporating the elastomer material portion of the portion that comes into contact with the face.

[0053] In a further embodiment, the entire portion that comes into contact with the face contains a permeable material, and the portion that comes into contact with the face is bonded to the portion that does not come into contact with the face by allowing the elastomer material of the portion that does not come into contact with the face to permeate the permeable material of the portion that comes into contact with the face.

[0054] According to at least one of the embodiments disclosed herein, a cushion for a breathing mask is provided. The cushion comprises an elastomer seal structure having a portion that contacts the face and a portion that does not contact the face, and a textile layer. The textile layer is permanently fixed to the outer surface of the portion of the elastomer seal structure that does not contact the face.

[0055] In a further embodiment, the part that comes into contact with the face includes an elastomer material.

[0056] In a further embodiment, the textile layer includes a non-stretchable textile.

[0057] In a further embodiment, the textile layer further comprises gaps configured to allow the textile layer to conform to the outer surface of the portion of the cushion that does not come into contact with the face.

[0058] In a further embodiment, the portion that comes into contact with the face further comprises a placement area for positioning the user's face relative to the mask, and a sealing area for providing a seal to the user's face.

[0059] In a further embodiment, the placement area comprises a continuous breathable surface such that a supply of breathing gas can be provided to the user's airway through the placement area during use.

[0060] In a further embodiment, the textile layer extends from the area where the part in contact with the face is positioned to the periphery of the part that does not come into contact with the face, at a distance from the opening that defines the intake port to the breathing chamber of the cushion.

[0061] In a further embodiment, the textile layer extends from the area where the part of the cushion comes into contact with the face to an exposed periphery that extends outward, past the air intake of the part of the cushion that does not come into contact with the face.

[0062] In a further embodiment, the arrangement region includes a three-dimensional knitted textile material.

[0063] In a further embodiment, the three-dimensional knitted textile material in the arrangement region comprises two or more layers.

[0064] According to at least one of the embodiments disclosed herein, a cushion for a breathing mask is provided. The cushion comprises a flexible sealing structure having at least one wall configured to seal against the user's face, and a textile layer. The textile layer is housed within at least one wall of the flexible sealing structure.

[0065] In a further embodiment, the textile layer is visible from the outside of the cushion through an elastomer material having a flexible sealing structure.

[0066] In a further embodiment, the flexible seal structure further comprises a second wall, wherein at least one wall and the second wall define a breathing chamber.

[0067] In a further embodiment, the textile layer extends continuously from at least one wall to a second wall, and the textile layer is housed within the second wall of the flexible seal structure.

[0068] In a further embodiment, at least one wall further comprises a placement area for positioning the user's face relative to the mask and a sealing area for providing a seal to the user's face.

[0069] In a further embodiment, the placement area comprises a continuous breathable surface such that during use, a supply of breathing gas can be provided through the placement area to at least one of the user's airways.

[0070] In a further embodiment, the arrangement region includes a three-dimensional knitted textile material.

[0071] In a further embodiment, the three-dimensional knitted textile material in the arrangement region comprises two or more layers.

[0072] According to at least one of the embodiments disclosed herein, a cushion for a breathing mask is provided. The cushion is a flexible seal structure having a face-contact portion configured to seal against the user's face and a non-face-contact portion, wherein the seal structure comprises an elastomer layer, a first textile layer, and a second textile layer. The first textile layer forms at least a portion of the face-contact portion, the second textile layer forms at least a portion of the non-face-contact portion, and the elastomer layer forms at least an internal portion of both the face-contact portion and the non-face-contact portion.

[0073] In a further embodiment, the first textile layer and the second textile layer are formed from a stretchable textile material.

[0074] In a further embodiment, the stretchable textile material includes a laminate of one or more textile sheet layers.

[0075] In a further embodiment, at least one of the first textile layer and the second textile layer is formed of a three-dimensional knitted textile material.

[0076] In a further embodiment, the portion that comes into contact with the face includes a mouth-nose opening configured to accommodate the user's nose and mouth.

[0077] In a further embodiment, the portion that comes into contact with the face is provided with a breathable area.

[0078] In a further embodiment, the first textile layer is formed of a first stretchable textile material, and the second textile layer is formed of a second stretchable textile material different from the first stretchable textile material.

[0079] In a further embodiment, the elastomer layer joins the first textile layer and the second textile layer at the seam.

[0080] In a further embodiment, the cushion further comprises a binder interposed between the inside of a first textile layer and the inside of a second textile layer, the binder joining the portion that comes into contact with the face and the portion that does not come into contact with the face, thereby defining a breathing chamber of the cushion.

[0081] In a further embodiment, the portion that comes into contact with the face and the portion that does not come into contact with the face define the outer surface of the non-face portion of the cushion, which is on the same plane.

[0082] In a further embodiment, the binder is an elastomer material.

[0083] According to at least one of the embodiments disclosed herein, a cushion for a breathing mask is provided. The cushion comprises a flexible seal structure having a first portion configured to be positioned toward the user's face and a second portion configured to be positioned away from the user's face, and a textile cover configured to be selectively positioned in a covered state, where the textile cover covers at least a portion of the first portion, or in an uncovered state, where the textile cover does not cover the first portion. The textile cover is permanently fixed to the cushion.

[0084] In a further embodiment, the first part defines the portion of the cushion that comes into contact with the face, and the second part defines the portion of the cushion that does not come into contact with the face.

[0085] In a further embodiment, the textile cover further comprises a first end fixed to the cushion and a free end opposite to the first end.

[0086] In a further embodiment, the first end of the textile cover is permanently fixed to the outer surface of the second portion of the cushion.

[0087] In a further embodiment, the first end of the textile cover is detachably fixed to the outer surface of the second portion of the cushion.

[0088] In a further embodiment, the first and second parts of the cushion define the breathing chamber.

[0089] In a further embodiment, the textile cover is fixed to at least a portion of the breathing chamber of the cushion.

[0090] In a further embodiment, the textile cover further includes a height smaller than the height and width of the cushion.

[0091] In a further embodiment, the first portion of the cushion further comprises a sealing area configured to engage with the user's face, and the textile cover further comprises a length sufficient such that, when covered, the free end at least partially covers the sealing area.

[0092] In a further embodiment, the cushion further comprises an opening for the mouth and nose in the first portion of the cushion, and the free end of the textile cover is configured to be fixed to the opening for the mouth and nose when covered.

[0093] In a further embodiment, the textile cover is formed from a stretchable textile material.

[0094] The features described above and other features of this disclosure should be more fully apparent when the following description and the attached claims are read in conjunction with the attached drawings. The disclosure is described with additional specificities and details through the use of the attached drawings, with the understanding that these drawings illustrate only some embodiments of this disclosure and should not be considered limiting its scope. [Brief explanation of the drawing]

[0095] [Figure 1] This is a diagram of a breathing system comprising an airflow generator, a humidifier, and a user interface. [Figure 2A] Figure 1 is a perspective view of a user interface equipped with a mask and headgear suitable for use in the respiratory system shown. [Figure 2B] Figure 1 is a side view of the user interface. [Figure 3A] Figure 1 is a perspective view of an exemplary cushion for use in a respiratory system. [Figure 3B] Figure 3A is a front view of the cushion. [Figure 3C] Figure 3A is a rear view of the cushion. [Figure 3D] Figure 3A is a side view of the cushion. [Figure 3E] Figure 3A is a top view of the cushion. [Figure 3F] Figure 3A is a bottom view of the cushion. [Figure 4A] Figures 3A to 3F are perspective views of exemplary thermoforming tools during the steps of the cushion formation process. [Figure 4B] Figures 3A to 3F are perspective views of exemplary thermoforming tools and workpieces after the steps in the cushion formation process. [Figure 4C] Figures 3A to 3F are perspective views of the exemplary overmolding tools and a portion of the cushion created from the workpiece after the steps in the cushion formation process. [Figure 4D] Figures 3A to 3F are perspective views of exemplary overmolding tools and parts of the cushion during the steps of the cushion formation process. [Figure 4E] Figures 3A to 3F are perspective views of some exemplary overmolding tools during the cushion formation process. [Figure 4F] Figures 3A to 3F are perspective views of some of the exemplary overmolding tools after the steps in the cushion formation process. [Figure 5] A perspective view of an alternative, exemplary cushion having a portion of the face-contacting area formed from silicone. [Figure 6A]This is a perspective view of an alternative, exemplary cushion having a portion that comes into contact with the face, where the textile layer is completely impregnated with silicone. [Figure 6B] Figure 6A is a front view of the cushion. [Figure 6C] Figure 6A is a rear view of the cushion. [Figure 6D] Figure 6A is a side view of the cushion. [Figure 6E] Figure 6A is a top view of the cushion. [Figure 6F] Figure 6A is a bottom view of the cushion. [Figure 7A] This is a perspective view of another alternative exemplary cushion having a portion that comes into contact with the face, comprising a sealing area formed from silicone and a placement area formed from a textile layer. [Figure 7B] Figure 7A is a front view of the cushion. [Figure 7C] Figure 7A is a rear view of the cushion. [Figure 7D] Figure 7A is a side view of the cushion. [Figure 7E] Figure 7A is a top view of the cushion. [Figure 7F] Figure 7A is a bottom view of the cushion. [Figure 8] A perspective view of another alternative, exemplary cushion having a portion of the face-contacting part with a sub-nose sling. [Figure 9A] A perspective view of another alternative, exemplary cushion having a face-contact portion with raised beads on the inner surface. [Figure 9B] Figure 9A is a side cross-sectional view of the cushion. [Figure 9C] Figure 9A is a cross-sectional view of the cushion with a side cutout. [Figure 10A] A perspective view of another alternative, exemplary cushion having a portion that comes into contact with the face, which includes a breathable placement area formed from a continuous textile surface. [Figure 10B] Figure 10A is a front view of the cushion. [Figure 10C]Figure 10A is a rear view of the cushion. [Figure 10D] Figure 10A is a side view of the cushion. [Figure 10E] Figure 10A is a top view of the cushion. [Figure 10F] Figure 10A is a bottom view of the cushion. [Figure 11A] Figures 10A to 10F show the back view of the cushion, indicating the cushion before the user's nose enters the ventilation area. [Figure 11B] Figures 10A to 10F are rear views of the cushion, showing the deformation of the cushion when the user's nose enters the central part of the ventilation area. [Figure 11C] Figures 10A to 10F are rear views of the cushion, showing the deformation of the cushion when the user's nose enters the upper part of the ventilation area. [Figure 12A] This is a perspective view of another alternative exemplary cushion having a breathable placement area formed from a continuous textile surface and frame clips attached to the frame connection openings of the cushion. [Figure 12B] Figure 12A is a front view of the cushion. [Figure 12C] Figure 12A shows the bottom and front of the cushion. [Figure 13A] This is a front view of an alternative, exemplary cushion having a non-stretchable textile placed around the part of the cushion that does not come into contact with the face. [Figure 13B] Figure 13A is a rear perspective view of the cushion, showing the part of the cushion that comes into contact with the face and the openings for the mouth and nose. [Figure 13C] Figures 13A and 13B are perspective views of exemplary overmolding tools during the cushion formation process. [Figure 14A] This is a rear perspective view of an alternative, exemplary cushion having a face-contacting portion with a breathable placement area constructed from a three-dimensional knitted textile material. [Figure 14B]Figure 14A is a front perspective view of the cushion, showing the part of the cushion that does not come into contact with the face. [Figure 15A] This is a rear perspective view of another alternative exemplary cushion having a face-contacting portion with a breathable placement area constructed from a three-dimensional knitted textile material. [Figure 15B] Figure 15A is a front perspective view of the cushion showing the portion of the cushion that does not come into contact with the face, where the three-dimensional knitted textile material extends to the opening in the portion of the cushion that does not come into contact with the face. [Figure 15C] Figures 15A, 15B, and 15D show cross-sectional views of the overmolding tool during the cushion formation process. [Figure 15D] Figures 15A and 15B are front perspective views of a portion of the cushion that does not come into contact with the face. [Figure 16A] Figures 16B and 16C are cross-sectional views of the forming tool during the cushion formation process. [Figure 16B] Figure 16C is a cross-sectional view of a portion of the cushion. [Figure 16C] This is a rear perspective view of an alternative, exemplary cushion having a textile portion that comes into contact with the face and a textile portion that does not come into contact with the face. [Figure 17A] Figures 17B and 17C show cross-sectional views of the forming tool during the steps of the cushion formation process. [Figure 17B] Figure 17C is a cross-sectional view of a portion of the cushion. [Figure 17C] This is a rear perspective view of another alternative, exemplary cushion having a textile portion that comes into contact with the face and a textile portion that does not come into contact with the face. [Figure 18A] This is a side view of an alternative, exemplary cushion having a portion that comes into contact with the face, a portion that does not come into contact with the face, and an uncovered textile cover. [Figure 18B] Figure 18A is a cross-sectional view of the cushion with the textile cover uncovered. [Figure 18C]Figure 18A is a rear view of the cushion with the textile cover in place. [Figure 18D] Figure 18A is a cross-sectional view of the cushion with the textile cover in place. [Modes for carrying out the invention]

[0096] Herein, embodiments of assembly and manufacturing systems, components, and methods will be described with reference to the accompanying drawings, where throughout, similar figures refer to similar or identical elements. While several embodiments, examples, and illustrations are disclosed below, those skilled in the art will understand that the invention described herein extends beyond the specifically disclosed embodiments, examples, and illustrations, and may include other uses and obvious modifications of the invention and their equivalents. Individual features of exemplary embodiments and / or different embodiments may be combined, other embodiments utilized, or structural modifications made without departing from the scope of the subject matter of the invention as described in the claims. The terms used in the descriptions presented herein are not intended to be constrained or restrictive solely because they are used in conjunction with the detailed descriptions of specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature is solely responsible for its desired attributes or is considered essential for carrying out the invention described herein.

[0097] In the following description, certain terms may be used for reference purposes only, and therefore these terms are not intended to be limiting. For example, terms such as “above” and “below” refer to directions in the referenced drawings. As used herein, the terms “front,” “rear,” “upper,” and “lower” refer to the position of a part or component of the breathing mask relative to the user. Here, “front” refers to a position distal to the user (when the mask is in use), and “rear” refers to a position relatively proximal to the user. The terms “upper” and “lower” refer to the position of a part or component of the mask relative to the rest of the mask when the mask is in use and the user is seated in an upright position. Furthermore, terms such as “first,” “second,” and “third” may be used to describe individual components. Such terms may include the words specifically mentioned above, their derivatives, and words with similar meanings.

[0098] Figure 1 is a schematic diagram of a positive airway pressure (CPAP) system 10 for providing a heated and humidified airflow to user U via an interface 110 worn by the user and connected to the CPAP system 10 by a conduit or tube 12. The humidification chamber 14 has a thermally conductive base that contacts a heater plate 16 of a humidifier 17 to humidify the airflow. The conduit 12 is connected to an exhaust port 13 of the humidification chamber 14 and carries the humidified air to the user interface 110. The humidifier 17 includes a controller 18, such as a microprocessor-based controller that executes computer software commands stored in associated memory, for example, but not limited to. The controller 18 receives input commands from multiple sources, including a user input interface 19, such as a dial or touchscreen, which allows setting predetermined values ​​for humidity, temperature, or other properties of the humidified air supplied to user U. The controller 18 can also receive input from one or more other sources, such as temperature and / or flow rate sensors 20 and 21, and / or a heater plate temperature sensor 23, which are connected via connector 22 to communicate with the controller 18. Depending on the selected humidity or temperature value, the controller 19 determines when and / or at what level the heater plate 16 should be energized to properly heat the water contained in the humidification chamber 14.

[0099] As the water mass in the chamber is heated, steam begins to fill the space in the chamber above the water surface. The steam is supplied from a supply source 25, such as a blower 27, and exits from the exhaust port 13 of the humidifying chamber along with the airflow that enters the humidifying chamber 30 through the intake port 26. The blower 27 may be a variable-speed fan or may be equipped with a variable pressure regulator. The blower 27 draws in air through the intake port 28. The blower may be controlled by, for example, a controller 29 or a controller 18. The controller 18 or 29 can control the speed of the blower, the regulated pressure, etc., according to any appropriate criteria. For example, the controller 29 may respond to input from the controller 18 and user-defined values ​​(e.g., preset values) of pressure and / or fan speed that can be set by a user interface 30 (e.g., a dial).

[0100] The seals and interfaces of this disclosure can be used in the CPAP systems described above, whether humidified or not, or alternatively, in other forms of respiratory systems such as VPAP (variable positive airway pressure) systems, BiPAP (bi-phase positive airway pressure) systems, or systems with ventilators, and are described herein more generally in relation to CPAP therapy as merely an example.

[0101] Figures 2A and 2B show an example of the interface assembly or interface 110 of system 10 in Figure 1. The interface 110 comprises a full-face mask 112, which in some configurations comprises a cushion 114 and a frame assembly or frame 116. The interface 110 also comprises a headgear 118 for securing the mask 112 to the user. The full-face mask 112 is configured to seal around the user's mouth and the underside of the user's nose. The features of the cushion embodiments described herein can be applied to any mask configuration, including but not limited to full-face masks and nose masks or direct nose masks. Thus, the description of features specific to the full-face mask is merely an example, and such descriptions can be replaced with appropriate descriptions of other mask or interface types. For example, references to openings for the mouth and nose can be replaced with references to openings for one or more noses.

[0102] In some configurations, the interface 110 also includes a short, flexible supply tube or tubing 120 extending from the mask 112, such as from a central connection on the front of the mask 112, which connects to a supply tube 12 of a CPAP system 10 or other breathing system. The conduit 120 connects to the mask 112 directly or via a suitable connector, such as a hollow elbow. In some configurations, the conduit 120 can swivel around one or more pivot axes relative to the mask 112 so that the path of the conduit 120 relative to the placement of the mask 112 on the user's face adapts to the user's sleeping position. The opposite end of the conduit 120 may have a suitable connector for connecting the conduit 120 to the supply tube 12. In some configurations, the connector may be a swivel connector that allows relative rotation between the conduit 120 and the supply tube 12, or may have a swivel connector.

[0103] As described above, the mask 112 may comprise a cushion 114 and a frame 116. In some configurations, the cushion 114 has a housing 124, and the housing 124 is coupled to the frame 116 such that the cushion 114 and the frame 116 together form an enclosure or breathing chamber having a gas inlet from the CPAP system 10, and an opening(s) 128 through the cushion 114 to the user. In some configurations, the frame 116 may be more rigid than at least a portion of the cushion 114.

[0104] Foam and silicone impregnation bonding Figures 3A to 3F show exemplary configurations of the cushion 114 of the mask 112 for use with the CPAP system 10 of Figure 1. As shown, the cushion 114 comprises a portion 202 that contacts the user's face and a portion 204 that does not contact the face. The portion 204 that does not contact the face forms the front-facing or relatively distal portion of the partially enclosed breathing chamber 130. The portion 204 that contacts the face forms the rear-facing or relatively proximal portion of the breathing chamber 130 and is configured to engage with the user's face and form a substantially airtight seal to the user's face. The portion 202 that contacts the face and the portion 204 that does not contact the face are connected by an intermediate region 206 along their respective edges.

[0105] The portion 202 that contacts the face contacts the user's face to provide a seal that substantially surrounds the user's nose and mouth. That is, the portion 202 that contacts the face engages with the user's face and is configured to form a substantially airtight seal to the user's face. The portion 202 that contacts the face has an oro-nasal opening 134 that receives the user's nose and mouth. Pressurized gas supplied by the conduit 120 enters the breathing chamber 130 and is received by the user through the oro-nasal opening 134.

[0106] The portion 202 that comes into contact with the face is formed from an open-cell foam material. Preferably, the portion 202 that comes into contact with the face is formed from an open-cell foam material 310 so that the portion of the cushion 114 that comes into contact with the user's face is soft in touch and appearance. That is, the open-cell foam material 310 provides a comfortable soft feel against the user's face and a comfortable and desirable appearance in a bedroom environment. The open-cell foam material 310 also provides structure and stability to the portion 202 that comes into contact with the face, while being adaptable to fit different facial geometries. The open-cell foam material 310 provides a lightweight portion 202 that reduces the overall weight of the cushion 114. A lighter cushion requires less headgear retention force than a heavier cushion, which can improve user comfort. The open-cell foam material 310 may also be breathable so that the user's skin can breathe, which improves the comfort of the cushion 114. In some embodiments, the open-cell foam material 310 may be airtight or may have at least some airtight areas. In other embodiments, the open-cell foam material 310 can form a leak diffuser that diffuses the flow of gas leaks, thereby preventing or suppressing spraying so that leaks are not noticeable or disruptive to the user.

[0107] In some configurations, the portion 202 that contacts the face may be formed from a thermoformable material, including an open-cell foam material 310 such as Breath-o-prene®. The portion 202 that contacts the face may be thermoformed to have a three-dimensional geometry contoured to engage with and conform to the user's face. Preferably, the portion 202 that contacts the face has a relatively thin wall structure (i.e., less than 5 mm thick). In some configurations, the portion 202 that contacts the face may have a constant or variable thickness along its length, width, and depth.

[0108] The open-cell foam material 310 of the portion 202 that comes into contact with the face may have an outer surface 212 that comes into contact with the user's face. The open-cell foam material 310 is lightweight, soft to the touch, and provides an aesthetically pleasing texture. In some embodiments, the open-cell foam has a textile cover that provides the outer surface 212. In some embodiments, the open-cell foam material may be in the form of a laminate comprising one or more textile sheet layers. In these embodiments, the textile may have a brushed, flocked, or pile / napped or textured surface that can interlock with the facial hair on the user's face. That is, the outer surface 212 may include a flocked textile. For example, Breath-o-prene® is a textile and foam laminate material with an outer textile layer.

[0109] In some configurations, the portion 204 that does not come into contact with the face defines the housing 124 of the cushion 114. The portion 204 that does not come into contact with the face has a frame connection opening 132 that engages with the frame 116 (see Figures 2A and 2B). The frame connection opening 132 provides an inlet through which the supply of pressurized air enters the breathing chamber 130. In the illustrated configuration, the portion 204 that does not come into contact with the face is formed from an elastic thermoplastic elastomer material such as silicone rubber 312 to provide a support structure and define an airtight breathing chamber 130 that allows pressurization of the air supplied to the user's airway. By forming the portion 204 that does not come into contact with the face from silicone rubber 312, the cushion 114 can be made lighter, more flexible, and more durable. Furthermore, the elastic silicone structure can provide support to the portion 202 that comes into contact with the face, thereby improving the ease with which the user can put on the mask.

[0110] The portion 202 that contacts the face is permanently bonded to the portion 204 that does not contact the face along the intermediate region 206. That is, the intermediate region 206 is positioned between the portion 202 that contacts the face and the portion 204 that does not contact the face. In some configurations, the intermediate region 206 may be substantially defined by the outer periphery and / or peripheral edge of at least one of the portion 202 that contacts the face and the portion 204 that does not contact the face. The portion 202 that contacts the face, the portion 204 that does not contact the face, and the intermediate region 206 together form an enclosure or breathing chamber 130 having a gas inlet from the system 10. As will be described in more detail below, the portion 204 that does not contact the face is bonded to the portion 202 that contacts the face along the intermediate region 206 by an overmolding process. As shown in the figure, the intermediate region 206 extends around the periphery of the cushion 114. In some configurations, the intermediate region 206 extends at least partially or completely around the periphery of the cushion 114. In some configurations, the periphery may be defined as the outer edge or extent of the cushion 114. For example, in some configurations, the intermediate region 206 may define the outermost periphery of the cushion 114, as shown in the front view of the cushion 114 in Figure 3B. The outermost periphery of the cushion 114 is the peripheral edge between the forward-facing surface and the rear-facing surface of the cushion 114. In other configurations, the intermediate region 206 may extend around the periphery of the cushion 114 that is radially inward from the outermost periphery of the cushion 114. In some configurations, the intermediate region 206 may be located on the forward-facing or rear-facing surface of the cushion 114.

[0111] The intermediate region 206 includes a seam 232 and a foam and fabric laminate material impregnation region 234. The seam 232 provides a butt joint between the open-cell foam material 310 of the portion 202 that contacts the face and the silicone rubber 312 of the portion 204 that does not contact the face. The seam 232 is positioned on the forward-facing surface of the cushion 114 so that the seam 232 does not come into contact with the user's face. The butt joint forms a smooth joint (e.g., coplanar) between the outer surfaces of the cushion 114 without sharp edges or steps. Furthermore, the raw edges of the open-cell foam material 310 of the thermoformed face-contact portion 202 are sealed by the overmolded silicone rubber 312, thereby providing a neat finish and preventing fraying or deterioration of the edges of the face-contact portion 202. The impregnated region 234 is formed during the overmolding process by impregnating the face-contacting portion 202 with silicone rubber 312 so that the face-contacting portion 202 and the non-face-contacting portion 204 are integrally formed. Impregnating the face-contacting portion 202 with silicone rubber 312 provides a strong mechanical bond between the open-cell foam material 310 and the silicone rubber 312, which supports the face-contacting portion 202 and can improve the durability of the cushion 114.

[0112] The seam 232 extends along the thickness of the edge of the portion 202 that contacts the face. In some configurations, the seam 232 extends around the widest edge of the cushion (when viewed from the front or rear of the cushion 114) so ​​that the seam 232 defines the periphery of the portion 202 that contacts the face. In some configurations, the seam 232 may provide a smooth and seamless transition between the portion 202 that contacts the face and the portion 204 that does not contact the face. In other configurations, the portion 202 that contacts the face and the portion 204 that does not contact the face may have raised or protruding portions that extend beyond the outer surfaces of the portion 202 that contacts the face and the portion 204 that does not contact the face. The seam 232 may have a constant or variable thickness along its length.

[0113] The intermediate region 206 is substantially formed from the outer periphery of both the portion 202 that contacts the face and the portion 204 that does not contact the face. The impregnation region 234 abuts against the seam 232 and extends from the seam 232 into the portion 202 that contacts the face. That is, the outer periphery of the portion 202 that contacts the face can be impregnated with silicone rubber 312 along the impregnation region 234. The impregnation region 234 is formed by impregnating the open-cell foam material 310 of the portion 202 that contacts the face with silicone rubber 312 during the overmolding process. That is, the impregnation region 234 is formed by permeating the overmolded silicone into the structure of the open-cell foam material 310. In some configurations, the open cells of the open-cell foam material 310 are filled with silicone rubber 312. In some configurations, the fibers of the textile cover providing the outer surface 212 are saturated with silicone rubber 312.

[0114] The impregnation region 234 extends from the front-facing side of the cushion 114 to the rear-facing side of the face-contacting portion 202 from the seam 232. In some embodiments, an overmolding tool can determine the shape, size, and geometry of the impregnation region 234. That is, the silicone rubber 312 may extend further into the open-cell foam material 310 in certain areas such that the impregnation region 234 is wider, deeper, and / or thicker in those areas compared to other areas. The areas where the silicone rubber 312 extends further into the open-cell foam material 310 may be stiffer and less flexible than the portions of the open-cell foam material 310 where the silicone rubber 312 extends over smaller or shallower distances. The shape, size, and depth of the impregnation region 234 can be adjusted to control or provide an intentional leak path and / or to increase the structure of certain areas of the face-contacting portion 202.

[0115] Manufacturing process Figures 4A to 4G show the steps for forming the cushion 114 from open-cell foam material 310 and liquid silicone rubber 312. Specifically, Figures 4A to 4G show the steps for forming the face-contact portion 202 from a sheet of open-cell foam material 310, and then overmolding the face-contact portion 202 with a non-face-contact portion 204 from liquid silicone rubber 312 to form the cushion 114 shown in Figures 3A to 3F.

[0116] As shown in Figure 4A, the open-cell foam material 310 is placed between the first and second thermoforming tool portions 302, 304 of the thermoforming tool 300. The open-cell foam material 310 may be in the form of a laminate containing one or more textile sheet layers. The first and second thermoforming tool portions 302, 304 compress the open-cell foam material 310 between them so that it conforms to the three-dimensional contours of the first and second thermoforming tool portions 302, 304. In some configurations, vacuum can be applied to the first and second thermoforming tool portions 302, 304 to apply force to conform the open-cell foam material 310 to the three-dimensional contours of the first and second thermoforming tool portions 302, 304, and / or to draw the open-cell foam material 310 into the cavities 306 of the portions that contact the faces of the first and second thermoforming tool portions 302, 304. The open-cell foam material 310 is heated to a forming temperature so that it is plastically deformed according to the geometry of the first and second thermoforming tool portions 302 and 304.

[0117] As shown in Figure 4B, the open-cell foam material 310 is cooled and removed from the first and second thermoforming tool parts 302 and 304. As shown, the open-cell foam material 310 is thermoformed and retains its three-dimensional contour shape. As shown in Figure 4C, the open-cell foam material 310 is cut to a size and shape that forms the face-contact portion 202 of the cushion 114. That is, the open-cell foam material 310 is trimmed and finished to form the outer periphery of the face-contact portion 202, and holes are formed in the open-cell foam material 310 to provide the shape of the face-contact portion 202, such as the mouth and nose openings 134. In some configurations, the open-cell foam material 310 may be die-cut, laser-cut, etc.

[0118] As shown in Figure 4D, the portion 202 that comes into contact with the face is positioned within the overmolding tool 320. The portion 202 that comes into contact with the face is inserted into the cavity 326 of the first molding tool portion 322 of the overmolding tool 320. As shown in Figure 4E, the molding tool core 324 is positioned on the first molding tool portion 322 and enclosed by a second molding tool portion (not shown), and liquid silicone rubber 312 is injected into the overmolding tool 320 under pressure to mold the portion 204 that does not come into contact with the face, and further to bond the portion 202 that comes into contact with the face with the portion 204 that does not come into contact with the face. The molding tool core 324 functions as an internal core through which the liquid silicone rubber 312 flows to form a sealed breathing chamber 130. In some configurations, the overmolding tool 320 may be injected with a thermoplastic material such as thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), or thermoplastic vulcanized material (TPV). After injection, the liquid silicone rubber 312 is cooled and solidified. As shown in Figure 4F, the cushion 114 is removed from the overmolding tool 320.

[0119] During the injection of liquid silicone rubber 312 into the overmolding tool 320, the periphery of the face-contact portion 202 is impregnated with liquid silicone rubber 312, forming an intermediate region 206. That is, the liquid silicone rubber 312 is forced to flow into the open outer edge of the face-contact portion 202 so that the face-contact portion 202 and the non-face-contact portion 204 are joined along their respective edges. A seam 232 is formed between the face-contact portion 202 and the non-face-contact portion 204, and the impregnation region 234 is formed by injecting the liquid silicone rubber 312 into the open-cell foam material 310 of the face-contact portion 202. The liquid silicone rubber 312 is pressed into the open-cell foam material 310, forming an impregnation region 234 that extends a distance D from the open outer edge of the face-contact portion 202 into the face-contact portion 202. In other words, distance D indicates the amount of silicone impregnation in the open-cell foam material 310 of the portion 202 that comes into contact with the face.

[0120] The amount of silicone impregnated into the open-cell foam material 310 can vary depending on the injection pressure of the liquid silicone rubber 312, the injection time, and the thickness of the face-contacting portion 202 relative to the thickness of the non-face-contacting portion 204. In some configurations, the thickness of the face-contacting portion 202 is substantially equal to the thickness of the non-face-contacting portion 204 so that the liquid silicone rubber 312 does not flow onto the outer surface 212 of the face-contacting portion 202. In some configurations, flow into the face-contacting portion 202 area can be restricted by narrowing or clamping the face-contacting portion 202. For example, the molding tool portion and molding tool core of the overmolding tool 320 may have areas that clamp or narrow the thickness of the face-contacting portion 202 of the open-cell foam material 310 so as to suppress the flow of liquid silicone rubber 312 into the open-cell foam material 310.

[0121] Partial foam and textile materials Figure 5 shows an alternative configuration for a cushion 114 for use with the CPAP system 10 of Figure 1. For the sake of brevity and convenience, explanations of certain similarities between the two configurations may be omitted herein, but such omissions are not limiting. The cushion 114 consists of a portion 202 that contacts the face and a portion 204 that does not contact the face. The portion 202 that contacts the face consists of a mouth region 142 and a nose region 144. The portion 204 that does not contact the face is formed from silicone rubber 312. The portion 202 that contacts the face has regions of silicone rubber 312 and / or open-cell foam material 310. More specifically, the nose region 144 of the portion 202 that contacts the face is formed from open-cell foam material 310, and the mouth region 142 is formed from silicone rubber 312. By forming the nose region 144 from the open-cell foam material 310, a soft texture is provided to the user's nose region, which is more sensitive to pressure, and a face-contact portion 202 is provided that effectively seals around the user's mouth. In some configurations, the nose region 144 may be formed from a textile material, a laminate material, and / or a foam and fabric laminate material. Similar to the cushion 114, the impregnated region 234 is formed by injecting liquid silicone rubber 312 into the open-cell foam material 310 of the face-contact portion 202, thereby providing a strong mechanical bond between the open-cell foam material 310 and the silicone rubber 312, which can improve the durability of the cushion 114.

[0122] The cushion 114 includes an intermediate region 206 with an impregnated region 234 extending around the periphery of the open-cell foam material 310. As shown in Figure 5, the intermediate region 206 extends from the outer periphery of the face-contacting portion 202 across the face-contacting portion 202 toward the mouth and nose opening 134. In some configurations, a portion of the intermediate region 206 may define a portion of the mouth and nose opening 134.

[0123] As shown in the figure, the cushion 114 has a portion 202 that comes into contact with the face, which is made up of a continuous portion or region of open-cell foam material 310 and a continuous portion or region of silicone rubber 312. In some configurations, both the mouth region 142 and the portion 204 that does not come into contact with the face are integrally formed from the continuous silicone rubber 312. That is, the mouth region 142 and the portion 204 that does not come into contact with the face are made of the same material. In other configurations, the mouth region 142 and the portion 204 that does not come into contact with the face are made from different materials.

[0124] In some configurations, multiple continuous portions or regions of the open-cell foam material 310 and / or silicone rubber 312 can be arranged around the portion 202 that comes into contact with the face. For example, the portion 202 that comes into contact with the face may include a second portion of the open-cell foam material 310 positioned near the portion of the face that comes into contact with the chin. It will be understood by those skilled in the art that the regions of the open-cell foam material 310 and / or silicone rubber 312 can be arranged in various regions on the portion 202 that comes into contact with the face (i.e., circumferential, radially inward / outward, periodic, or any combination thereof) to provide the user with comfort, breathability, airtightness, flexibility, etc. That is, any portion of the open-cell foam material 310 can be impregnated with silicone rubber 312.

[0125] Fully impregnated textile material Figures 6A to 6F show alternative configurations of the cushion 414 for use with the CPAP system 10 of Figure 1. For the sake of brevity and convenience, explanations of certain similarities between the two configurations may be omitted herein, but such omissions are not limiting. The cushion 414 consists of a portion 202 that contacts the face and a portion 204 that does not contact the face. The portion 202 that contacts the face has a composite material structure including a layer of textile material 310 overmolded with silicone rubber 312. In other words, the textile material 310 is completely impregnated with silicone rubber 312 such that both the inner and outer surfaces of the portion that contacts the face are formed from silicone rubber 312. That is, the entire portion 202 that contacts the face consists of textile material 310 impregnated with silicone rubber 312.

[0126] The fully impregnated textile material 310 of the portion 202 that comes into contact with the face provides the properties of both the textile material 310 and the silicone rubber 312. The portion 202 that comes into contact with the face has the appearance of a textile while providing the surface texture of silicone rubber. The appearance of the textile can provide a softer aesthetic, which may be comfortable and desirable in a bedroom environment. The textile material 310 may also have a color that contrasts with the silicone rubber 312, which provides an aesthetically pleasing appearance. The contrasting color may also provide the user with visual guidance regarding the placement and fit of the cushion 414 on the user's face. The silicone surface texture makes the portion that comes into contact with the face airtight, and the airtight portion that comes into contact with the face easily seals against the user's face. The fully impregnated textile material 310 also provides a support structure and an airtight breathing chamber that allows pressurization of the supply of air to the user's airway. In some configurations, the airtight structure provided by the fully impregnated textile material 310 can be used in conjunction with porous and air-permeable areas so that airflow can be guided and / or diffused away from the user. The support structure also improves the positioning and fit of the cushion to the user's face. Furthermore, the impregnated silicone rubber 312 provides an elastic structure that allows the face-contacting portion 202 to conform to the geometry of various users' faces.

[0127] In some configurations, the portion 204 that does not come into contact with the face may have a greater (i.e., thicker) wall thickness than the portion 202 that does come into contact with the face. That is, the wall thickness of the silicone rubber 312 in the portion 202 that comes into contact with the face may be thinner than the wall thickness of the silicone rubber 312 in the portion 204 that does not come into contact with the face, so that the portion 202 that comes into contact with the face may be more flexible than the portion 204 that does not come into contact with the face. The thicker portion 204 that does not come into contact with the face also increases the rigidity of the housing 124 and the breathing chamber 130 of the cushion 414. In some configurations, the portion 204 that does not come into contact with the face may have a wall thickness substantially equal to that of the portion 202 that comes into contact with the face.

[0128] Cushion 414 is manufactured using an overmolding tool similar to that used for cushion 114. In some configurations, the textile material 310 of the portion 202 that comes into contact with the face does not require thermoforming (shown in Figure 4A) and trimming (shown in Figure 4B) before being inserted into the overmolding tool 320. More specifically, the textile material 310 is stretched onto the first molding tool portion 322 of the overmolding tool 320 before being overmolded, and then any excess textile material 310 is trimmed. In some configurations, the textile material 310 may be placed within the first molding tool portion 322 and overmolded so that the particles of the textile material 310 conform to the curvature of the portion 202 that comes into contact with the face. By oriented the direction of the particles of the textile material 310 toward the portion 204 that does not come into contact with the face and / or toward the user, user comfort, airtightness, positionability, aesthetics, etc., can be improved.

[0129] Textile and silicone impregnation bonding Figures 7A to 7F show alternative configurations of the cushion 424 for use with the CPAP system 10 of Figure 1. For the sake of brevity and convenience, explanations of the specific similarities between the two configurations may be omitted herein, but such omissions are not limiting. As shown, the cushion 424 comprises a portion 202 that contacts the user's face and a portion 204 that does not contact the face. The portion 204 that does not contact the face is formed from a thermoplastic elastomer material such as silicone rubber 312. In some configurations, the portion 204 that does not contact the face may have a greater (i.e., thicker) wall thickness than the portion 202 that contacts the face. In other configurations, the portion 204 that does not contact the face may have a wall thickness substantially equal to that of the portion 202 that contacts the face.

[0130] The portion 202 that comes into contact with the face consists of a placement area 242 and a sealing area 244. The sealing area 244 is formed from an elastomer material such as silicone rubber 312, which provides a smooth, continuous surface that engages with the user's face to form an airtight seal around the user's nose and mouth. The sealing area 244 and the portion 204 that does not come into contact with the face may be formed from the same material. For example, both the sealing area 244 and the portion 204 that does not come into contact with the face can be formed from silicone rubber 312. In some configurations, the sealing area 244 and the portion 204 that does not come into contact with the face may be formed from different materials. The sealing area 244 extends around the periphery of the placement area 242. That is, the sealing area 244 is positioned radially outward of the placement area 242 with respect to the mouth and nose opening 134. In other words, the sealing area 244 surrounds the placement area 242. The sealing area 244 is formed integrally with the portion 204 that does not come into contact with the face, and may be part of the portion 204 that does not come into contact with the face, located on the rear side of the cushion 424 or on the side facing the user.

[0131] The placement area 242 is formed from a double-layer textile material 314. The textile layer of the placement area 242 is configured to conform to the geometry of the user's face and to position the cushion on the user's face (i.e., visually, tactilely, etc.). In some embodiments, the double-layer textile material 314 may comprise first and second layers having different properties. For example, the double-layer textile material 314 may include a laminate having at least one airtight layer to increase the sealing area 244 that contacts the user's face and improve the seal achieved. The double-layer textile material 314 may also comprise at least one comfort layer to enhance the softness, cushioning, texture, breathability, etc., of the placement area 242. In some configurations, the placement area 242 may comprise a single layer or multiple layers.

[0132] The double-layer textile material 314 in the placement area 242 is formed integrally with the seal area 244. That is, the outer periphery of the double-layer textile material 314 is overmolded into the seal area 244. A transition area 208 is positioned and extends between the placement area 242 and the seal area 244. As shown in Figures 7A and 7C, the transition area 208 may be the peripheral edge between the placement area 242 and the seal area 244, which is positioned on the rear and user-facing surface of the cushion 114. In some configurations, the transition area 208 may be the peripheral edge between the front-facing surface and the rear-facing surface of the cushion 424.

[0133] The transition region 208 comprises a seam 232 and a textile impregnation region 234. The seam 232 is formed by the transition from the single-layer textile material 316 of the placement region 242 to the silicone rubber 312 of the seal region 244. The impregnation region 234 is formed by impregnating the double-layer textile material 314 of the placement region 242 with silicone rubber 312 during the overmolding process so that the placement region 242 and the seal region 244 are formed integrally. Thus, the transition region 208 includes a composite material of the double-layer textile material 314 and silicone rubber 312. The seam 232 extends around the periphery of the textile impregnation region 234 and can provide a smooth and seamless transition between the placement region 242 and the seal region 244. The impregnation region 234 extends around the radial outer circumference of the double-layer textile material 314, and the silicone rubber 312 penetrates into the double-layer textile material 314 from the seam 232. The transition region 208 and the sealing region 244 are configured to form a substantially airtight seal against the user's face.

[0134] Similar to the impregnation process described above, the impregnation region 234 is formed by impregnating the double-layer textile material 314 with silicone rubber 312 using an overmolding tool 320. The overmolding tool 320 can determine the size and shape of the impregnation region 234. That is, it can impregnate a specific area of ​​the double-layer textile material 314 with silicone rubber 312 to provide an impregnation region 234 with a shape that improves the seal with the user's face. Similarly, the silicone rubber 312 may also provide an impregnation region 234 with a shape that limits or suppresses the penetration of specific areas of the double-layer textile material 314, allowing airflow to pass through the placement region 242. In some embodiments, the silicone rubber 312 of the impregnation region 234 can have a variable thickness (i.e., some areas can be thicker than others).

[0135] Cushion 424 is manufactured using an overmolding tool similar to that used for cushion 114. In some configurations, the double-layer textile material 314 of the portion 202 that comes into contact with the face does not require thermoforming (shown in Figure 4A) and trimming (shown in Figure 4B) before being inserted into the overmolding tool 320. More specifically, the double-layer textile material 314 is cut and sized to fit within the first molding tool portion 322 of the overmolding tool 320 before being overmolded.

[0136] The double-layer textile material 314 in the placement area 242 provides a three-dimensional shape that is softer to the touch than the silicone rubber surface and provides color detail to the seal. Thus, the cushion 424 is more comfortable against the user's face, comfortable in a bedroom environment, and has a desirable appearance. The double-layer textile material 314 in the placement area 242 also provides flexibility and conformability to the portion 202 that comes into contact with the face, as a result of the flexible nature of the double-layer textile material 314. In some configurations, the double-layer textile material 314 in the placement area 242 may be formed such that a portion of the double-layer textile material 314 is under tension. That is, tension may be generated within the double-layer textile material 314 during the overmolding process. The tension provides a certain degree of elasticity, ensuring that the cushion 424 is securely positioned on the user's face.

[0137] Under-nose sling Figure 8 shows an alternative configuration for a cushion 434 for use with the CPAP system 10 of Figure 1. For the sake of brevity and convenience, explanations of certain similarities between the two configurations may be omitted herein, but such omissions are not limiting. As illustrated, the cushion 434 comprises a portion 202 that contacts the user's face and a portion 204 that does not contact the face. The portion 202 that contacts the face consists of a placement area 242 and a sealing area 244. The placement area 242 of the face-contacting portion 202 consists of a single-layer textile material 316 formed integrally with the sealing area 244. The outer periphery of the single-layer textile area 316 is overmolded into the sealing area 244. In some configurations, the placement area 242 may include a textile material having multiple layers. In some configurations, the placement area 242 may have a continuous surface formed from a breathable material so that during use, a supply of breathing gas can be delivered to the user's airway through the placement area.

[0138] The placement area 242 includes two openings, including a mouth opening 136 and a nose opening 138. The mouth opening 136 is configured to surround the user's mouth, and the nose opening 138 is configured to surround the user's nostrils. That is, the mouth opening 136 is configured to provide a supply of breathing gas to the user's mouth, and the nose opening 138 is configured to provide a supply of breathing gas to the user's nostrils. The mouth opening 136 and the nose opening 138 form a subnasal sling 140, which is a strip of textile material extending laterally across the portion 202 that contacts the face. The subnasal sling 140 is positioned below the user's nose and is configured to help position the cushion 434 over the user's face and to prevent the cushion 434 from riding up over the user's face. That is, the subnasal sling 140 prevents improper fitting of the cushion 434 by preventing the user's nose from going too deep into the cushion 434. The nasal sling 140 may be formed by cutting holes for a mouth opening 136 and a nose opening 138 in a single layer textile material 316. In some configurations, the nasal sling 140 is defined by a mouth opening 136 and a nose opening 138.

[0139] A transition region 208 is positioned between the placement region 242 and the sealing region 244. The transition region 208 comprises a seam 232 and a textile impregnation region 234. The seam 232 is formed by the transition from the single-layer textile material 316 of the placement region 242 to the silicone rubber 312 of the sealing region 244. The impregnation region 234 is formed by impregnating the single-layer textile material 316 of the placement region 242 with silicone rubber 312 during the overmolding process so that the placement region 242 and the sealing region 244 are formed integrally. Thus, the transition region 208 includes a composite material of the single-layer textile material 316 and silicone rubber 312. The seam 232 extends around the periphery of the textile impregnation region 234 and can provide a smooth and seamless transition between the placement region 242 and the sealing region 244.

[0140] Textile and silicone impregnation bonding Figures 9A–9C show alternative configurations of the cushion 444 for use with the CPAP system 10 of Figure 1. For the sake of brevity and convenience, explanations of certain similarities between the two configurations may be omitted herein, but such omissions are not limiting. Similar to the cushion 434 of Figure 8, the cushion 444 consists of a placement area 242 having two openings, including an opening 136 for the mouth and an opening 138 for the nose that define the subnasal sling 140.

[0141] In contrast to cushion 434 in Figure 8, cushion 444 has a transition region 208 consisting of a seam 232 with a raised bead 236 on the inner surface 218 of the face-contact portion 202. The raised bead 236 is part of the face-contact portion 202 and extends inward toward the enclosed breathing chamber 130. Thus, the seam 232 has increasing thickness extending from the inner surface of the transition region toward the interior of cushion 444. The raised bead 236 extends around the seam 232 along the periphery of the placement region 242. The raised bead 236 extends on the interior or inward-facing surface 248 of the double-layer textile material 314. Figure 9B shows the raised bead 236 applied to a placement region 242 formed from a single-layer textile region 316. Figure 9C shows a raised bead 236 applied to a placement area 242 formed from a double-layer textile area 314. The raised bead 236 is configured to enhance the bond to the seam 232 and the structural strength. The thickness of the raised bead 236 is increased on the inner surface 218 of the face-contacting portion 202 so as not to hinder the ability of the face-contacting portion 202 to form a seal against the user's face. That is, the outer surface of the face-contacting portion 204 is a smooth, continuous surface that enhances the bond and structural strength while providing a comfortable surface against the user's face and a substantially airtight seal.

[0142] Silicone-impregnated textile seal area without openings Figures 10A to 10F show alternative configurations of the cushion 454 for use with the CPAP system 10 of Figure 1. For the sake of brevity and convenience, explanations of certain similarities between the two configurations may be omitted herein, but such omissions are not limiting. Similar to the cushion 114 of Figure 8, the cushion 454 comprises a portion 202 that contacts the user's face and a portion 204 that does not contact the face. In contrast to the cushion 114, the cushion 454 does not have openings for the mouth and nose. The portion 202 of the cushion 454 that contacts the face comprises a continuous, uninterrupted sheet of stretchable textile material 318 without openings for receiving the user's nose and / or mouth. The portion 202 that contacts the face comprises a breathable placement area 238 and a sealing area 244. The breathable placement area 238 is a porous and breathable area so that the pressurized gas in the breathing chamber 130 is received by the user through the stretchable textile material 318. In other words, the user can breathe through the breathable placement area 238. In some configurations, the sealing area 244 is formed from a composite material such as silicone rubber-impregnated open-cell foam or textile material. In other configurations, the sealing area 244 is formed from silicone rubber 312. The sealing area 244 extends around the periphery of the breathable placement area 238. That is, the sealing area 244 is positioned radially outward of the breathable placement area 238 with respect to the mouth and nose opening 134. In other words, the sealing area 244 surrounds the breathable placement area 238.

[0143] Similar to the cushion 114 in Figure 8, the portion 204 that does not come into contact with the face is bonded to the outer circumference of the portion 202 that comes into contact with the face along the intermediate region 206 by an overmolding process. That is, the portion 204 that does not come into contact with the face comprises an impregnated region 234 in which the stretchable textile material 318 is impregnated with silicone rubber 312 along the outer circumference of the stretchable textile material 318. The breathable placement region 238, which is not impregnated with the stretchable textile material 318, is located radially inward of the impregnated region 234. That is, the outer circumference of the portion 202 that comes into contact with the face is impregnated with silicone rubber 312, while the inner region of the portion 202 that comes into contact with the face is not impregnated with silicone rubber 312. The outer circumference of the breathable placement region 238 is defined by the inner circumference of the impregnated region 234. As shown in Figure 10C, the inner circumference of the impregnated region 234 and the outer circumference of the breathable placement region 238 are defined by dashed lines.

[0144] The stretchable textile material 318 of the breathable placement area 238 has a predetermined three-dimensional contour, at least partially determined by the geometry of the sealing surface, when not in use. The stretchable textile material 318 is supported under tension by the sealing area 244 to form the predetermined three-dimensional contour. That is, a portion of the stretchable textile material 318 can be subjected to tension such that the breathable placement area 238 has a contour shape when it is not in use and no force is applied to the breathable placement area 238. The breathable placement area 238 may be formed from a material that is stretchable along a single axis, two axes, or multiple axes. By providing axes of stretching, it is possible to determine how the breathable placement area 238 stretches when worn by a user. In some configurations, the breathable placement area 238 may be formed from a non-stretchable textile, foam, or laminated material.

[0145] When the cushion 454 is fitted, the user's nose is pressed down against the breathable placement area 238, which is displaced toward the breathing chamber 130. As shown in Figures 11A to 11C, the absence of mouth and nose openings in the face-contacting portion 202 facilitates the upper corners 222 of the face-contacting portion 202 constricting inward toward the sides of the user's nose when the user's nose is pressed down against the breathable placement area 238. That is, when the user's nose protrudes into the face-contacting portion 202, the stretchable textile material 318 becomes taut and displaces into the breathing chamber 130 of the cushion 454. As a result of the stretchable textile material 318 being pushed into the breathing chamber 130 of the cushion 454, the stretchable textile material 318 pulls its upper corners 222 toward each other into the breathing chamber 130. The upper corners 222 may deform radially inward and / or collapse as a result of being pulled toward each other. As a result, the sealing area 244 of the portion 202 that comes into contact with the face sandwiches the sides of the user's nose, thus improving the seal between the cushion 454 and the user's face.

[0146] The breathable placement area 238 is configured to receive the user's nose and mouth. That is, the stretchable textile material 318 may be configured to stretch to conform to the shape of the user's nose. In some configurations, the breathable placement area 238 may have a certain amount of looseness, slack, or drooping so that the breathable placement area 238 is loose and substantially tensionless when the cushion 454 is not worn by the user. This looseness can reduce the tension of the breathable placement area 238, thereby reducing the pressure on the user's nose. In some configurations, the stretchable textile material 318 may be formed of bellows or pleats that are molded and configured to expand when the user's nose is pressed down against the breathable placement area 238. In other configurations, the breathable placement area 238 may be formed of an elastic material so that the breathable placement area 238 stretches when the user's nose is pressed down against it. In some embodiments, the stretchable textile material 318 may include a laminated material having at least one layer that is airtight in some areas in order to increase the sealing area 244 that comes into contact with the user's face and to improve the sealing performance of the portion 202 that comes into contact with the face.

[0147] Cushion 414 is manufactured using an overmolding tool similar to that used for cushion 114. In some configurations, the stretchable textile material 318 of the portion 202 that comes into contact with the face does not require thermoforming (shown in Figure 4A) and trimming (shown in Figure 4B) before being inserted into the overmolding tool 320. More specifically, the stretchable textile material 318 is a flexible sheet that is stretched onto the first molding tool portion 322 of the overmolding tool 320 before being overmolded. In some configurations, a vacuum can be applied to the first and second thermoforming tool portions 302, 304 to maintain the stretchable textile material 318 in a stretched state. By stretching the stretchable textile material 318 before overmolding, the breathable placement area 238 may contain a certain amount of looseness, slack, or drooping so that the breathable placement area 238 is loose and substantially tensionless when the cushion 454 is not being worn by a user. After the cushion 454 is overmolded with silicone rubber 312, the excess stretchable textile material 318 is trimmed at the seam 232. The overmolding tool 320 may include a barrier zone that defines and limits how much of the silicone rubber 312 flows into the stretchable textile material 318. The depth of penetration into the stretchable textile material 318 defines the shape of the seal area 244.

[0148] By providing slack in the breathable placement area 238, the tension that may be applied to the tip of the user's nose when inserted into the cushion 414 is reduced. Without slack, the textile material 318 would need to stretch over the user's nose, which could result in an increased level of tension on the nose, potentially causing discomfort.

[0149] Silicone-impregnated textile seal area with silicone stabilizing layer Figures 12A–12C show alternative configurations of cushion 464 for use with the CPAP system 10 of Figure 1. Descriptions of certain similarities between the two configurations may be omitted herein for brevity and convenience, but such omissions are not limiting. Similar to cushion 454 in Figures 10A–10F, cushion 464 features a porous, breathable ventilation placement area 238 for the user to receive pressurized gas from the breathing chamber 130. In contrast to cushion 454, cushion 464 features a stabilizing layer 246 beneath the stretchable textile material 318 of the face-contact portion 202. That is, the stabilizing layer 246 is positioned between the breathing chamber 130 and the stretchable textile material 318 of the face-contact portion 202. The stabilizing layer 246 is positioned on the upper half of the face-contact portion 202 and is configured to apply pressure to the patient's nose during use, stabilizing the cushion on the patient's face.

[0150] As shown in the figure, the stabilizing layer 246 has an inverted U-shape configured to provide support to the stretchable textile material 318 of the face-contacting portion 202 around the user's nasal bridge and cheek area. That is, the stabilizing layer 246 may have an arched contour shape extending between the cheek areas of the cushion 464 on both sides of the cushion 464 and over the nasal bridge area of ​​the face-contacting portion 202. The stabilizing layer 246 enhances the stability of the cushion 464 on the user's face and prevents the housing 124 from digging into the user's nasal bridge as a result of the face-contacting portion 202 being crushed due to overtightening of the mask during wear. Thus, the stabilizing layer 246 improves the sealing performance of the face-contacting portion 202.

[0151] The stabilization layer 246 is formed from silicone rubber 312 and may be formed independently of or integrally with the portion 204 that does not come into contact with the face. The stabilization layer 246 is separated from and / or not attached to the stretchable textile material 318. The stabilization layer 246 has an outer edge attached to the inner circumference of the sealing region 244 and an inner edge extending into the breathing chamber 130. That is, the stabilization layer 246 may have a first end fixed to the sealing region 244 and a second end that is free. The stabilization layer 246 includes a three-dimensional layer of silicone rubber positioned beneath the stretchable textile material 318 of the portion 202 that comes into contact with the face. The stabilization layer 246 may have a thickness greater than, less than, or equal to the thickness of the portion 204 that does not come into contact with the face. In some configurations, the stabilization layer 246 may replace or be added to the impregnation region 234 of the sealing region 244. In other configurations, the stabilizing layer may be provided in other areas of the cushion, such as but not limited to the jaw region or the upper lip region (for the nasal interface). In some configurations, the stabilizing layer 246 may comprise multiple layers, each positioned on either side of the user's nose during use. In some configurations, the stabilizing layer 246 may be positioned on either side of the user's nose during use, but not extending beyond the user's nasal bridge.

[0152] Figures 9B, 11B, and 11C show frame clips 252 attached to the housing 124 of the cushions 444, 464. The frame clips 252 are rigid rings formed from plastic that are permanently attached to the frame connection openings 132 of the housing 124. The frame clips 252 provide a removable connection between the mask frame and the cushions. The frame clips 252 may comprise an inner portion 254 and an outer portion 256 that are permanently joined to each other by snap fittings, friction fittings, welded joints, etc. The frame clips 252 provide a more reliable connection to the frame than directly connecting the silicone housing to the frame. That is, the increased rigidity of the frame clips 252 reduces the possibility of leakage between the cushions 444, 464 and the conduit 120 due to bending or deformation of the cushions 444, 464.

[0153] Partially impregnable textile material Figures 13A to 13C show an exemplary configuration of a cushion 510 for use with the CPAP system 10 of Figure 1. The cushion 510 comprises a portion 202 that contacts the face and a portion 204 that does not contact the face. The portion 204 that does not contact the face forms the front-facing or relatively distal portion of the partially enclosed breathing chamber 130, as described above. The portion 202 that contacts the face forms the rear-facing or relatively proximal portion of the breathing chamber 130 and is configured to engage with the user's face and form a substantially airtight seal against the user's face. An intermediate region 206 interconnects the portion 202 that contacts the face and the portion 204 that does not contact the face along their respective edges.

[0154] The portion 202 that contacts the face contacts the user's face to provide a seal that substantially surrounds the user's nose and mouth. That is, the portion 202 that contacts the face engages with the user's face and is configured to form a substantially airtight seal to the user's face. The portion 202 that contacts the face has an oro-nasal opening 134 that receives the user's nose and mouth. Pressurized gas supplied by the conduit 120 enters the breathing chamber 130 and is received by the user through the oro-nasal opening 134.

[0155] The portion 202 that comes into contact with the face may include a sealing area 244. As shown in the figure, both the portion 202 that comes into contact with the face and the sealing area 244 are formed from an elastomer material such as silicone rubber 312, which provides a smooth, continuous surface that engages with the user's face to form an airtight seal around the user's nose and mouth (i.e., an airtight seal around the mouth-nose opening 134). The portion 204 that does not come into contact with the face may also be formed from silicone rubber 312. The silicone rubber 312 may be continuously arranged around the portion 202 that comes into contact with the face or in various areas of the portion 202 that comes into contact with the face to provide the user with comfort, airtightness, flexibility, etc. In other embodiments, the portion 202 that comes into contact with the face and the portion 204 that does not come into contact with the face may be formed from different materials such as TPE material, or may include different materials.

[0156] The portion 204 that does not come into contact with the face may have a double-layer structure including a lower or inner layer and an upper or outer layer. The lower layer may be formed of the same silicone rubber 312 or elastomer material as the portion 202 that comes into contact with the face. The upper layer may be formed of a textile such as a non-stretchable textile 513, but in some configurations it may be formed of a stretchable textile. In other configurations the top layer may be formed of a textile 513 having a blend of two or more fibers. In such configurations the textile 513 may include a blend of about 70-90% nylon and 10-30% polyester woven microfiber. For example the textile may include a blend having about 70% nylon and about 30% polyester woven microfiber, or about 80% nylon and about 20% polyester woven microfiber, or about 90% nylon and about 10% polyester woven microfiber, but other percentage compositions and other suitable textile materials may be used. A suitable non-stretchable or stretchable textile 513 can withstand the high temperatures of the tools used during the curing process of the liquid silicone rubber 312 (i.e., it will not melt at high temperatures). The non-stretchable textile 513 may be arranged continuously around the portion 204 that does not come into contact with the face, such that the portion 204 that does not come into contact with the face is substantially covered by the non-stretchable textile 513. As shown in Figure 13A, in some configurations, the non-stretchable microfiber textile 513 may be spaced away from the edges of the mouth and nose opening 134. Thus, a portion of the underlayer of the portion 204 that does not come into contact with the face may be exposed between the non-stretchable microfiber textile 513 and the mouth and nose opening 134.

[0157] The non-stretchable textile 513 includes textiles formed of high-density fibers, such as non-stretchable microfiber textile 513. Microfiber textiles, such as non-stretchable microfiber textile 513, generally have a fiber diameter of less than 1 denier (i.e., less than about 10 micrometers). During the manufacture of the cushion 510, the non-stretchable textile 513 is placed in the cavity of the overmolding tool 320, and liquid silicone rubber 312 is injected into the overmolding tool 320 to bond the non-stretchable textile 513 with a portion of the injected silicone rubber 312, forming a portion 204 of the cushion 510 that does not come into contact with the face. The liquid silicone rubber 312 is partially pressed into the fibrous structure of the non-stretchable textile 513 on the user-facing side or the inner side. In contrast to the fully impregnated textile material shown in Figures 6A to 6F, the high-density fibrous structure of the non-stretchable textile 513 is at least partially impregnable to the flow of liquid silicone rubber 312. Instead, while the non-stretchable textile 513 is attached to the underlayer of the non-face-contacting portion 204, the silicone rubber 312 can only penetrate a portion of the thickness of the user-facing side of the non-stretchable textile 513. Thus, the non-stretchable textile 513 is fixed to the underlayer of the non-face-contacting portion 204, but forms a forward-facing textile surface 511 that is not saturated by the silicone rubber 312 on the exposed side of the non-stretchable textile 513. In some configurations, a material other than the non-stretchable microfiber textile 513 can be used to form the forward-facing textile surface 511, such as the Breath-o-prene® material described above. In further configurations, the Breath-o-prene® material forms all or part of the non-face-contacting portion 204.

[0158] As described above, the portion 204 of the cushion 510 that does not come into contact with the face comprises a forward-facing textile surface 511 that retains the texture, appearance, and other properties of the non-stretchable textile 513. The portion 204 that does not come into contact with the face is often the most visible and prominent aspect of the cushion 511 when it is worn by the user. Preferably, the forward-facing textile surface 511 is included that provides a more comfortable and visually appealing textile aesthetic in a bedroom environment while retaining the soft feel of the non-stretchable textile 513. In some configurations, the non-stretchable textile 513 may also have a contrasting color to the silicone rubber 312, which provides an aesthetically pleasing appearance. The contrasting color may also provide the user with visual instructions regarding the placement and fit of the cushion 510 on the user's face. This contrasting color may also provide visual assembly instructions or cues for assembling the cushion 510 together with the other components of the CPAP mask system 10. The forward-facing textile surface 511 also protects the silicone rubber structure beneath the cushion 510 from abrasion and wear caused by the user's hands when putting on or taking off the cushion 510.

[0159] The continuous curvature of the portion 204 that does not come into contact with the face and the non-stretchability of the non-stretchable textile 513 increase the difficulty of securing the non-stretchable textile 513 to the portion 204 that does not come into contact with the face, while simultaneously obtaining a smooth (e.g., wrinkle-free) surface finish as shown in Figure 13A. As shown in Figure 13C, the non-stretchable textile 513 may include one or more gaps 514 that allow the substantially two-dimensional non-stretchable textile 513 to conform to the three-dimensional shape of the overmolding tool 320 and ultimately the cushion 510. Each gap 514 provides an additional degree of freedom that allows the non-stretchable textile 513 to conform more closely to the three-dimensional shape of the cushion 510. Each of the one or more gaps 514 may extend from the outer circumference of the non-stretchable textile 513 to the inner circumference of the non-stretchable textile 513. Therefore, the gap 514 can extend from the outer periphery of the non-stretchable textile 513 to the outer periphery of the mouth and nose opening 134. In some configurations, the gap 514 does not have to extend over the entire distance between the outer and inner periphery of the non-stretchable textile 513. In further configurations, the non-stretchable textile 513 may include a gap 514 positioned at the bottom of the cushion 510 (e.g., near the user's jaw area) to provide a cleaner aesthetic to the portion of the cushion 510 visible to the user during use.

[0160] Textile and silicone impregnation bonding Figures 14A and 14B show the configuration of the cushion 520 for use with the CPAP system 10 of Figure 1. Similar to the cushion 454 in Figures 10A to 10F, the cushion 520 comprises a portion 202 that contacts the user's face and a portion 204 that does not contact the face. The face-contact portion 202 of the cushion 520 does not include an opening 134 for the mouth and nose, but instead comprises a continuous and uninterrupted three-dimensional knitted textile material 521 to receive the user's nose and / or mouth. The face-contact portion 202 comprises a breathable placement area 238 and a sealing area 244. The breathable placement area 238 is a porous and breathable area so that the pressurized gas in the breathing chamber 130 is received by the user through the stretchable textile material 521. The breathable placement area 238 is located in the center of the face-contact portion 202 and engages with and / or covers the user's nose and / or mouth. In some configurations, the sealing area 244 is formed from a composite material such as silicone rubber 312 impregnated within a three-dimensional knitted textile material 521 to provide a comfortable surface against the user's face and a substantial airtight seal. In other configurations, the sealing area 244 is formed solely from silicone rubber 312. The sealing area 244 extends around part or all of the periphery of the breathable placement area 238. That is, the sealing area 244 is positioned radially outward of the breathable placement area 238 with respect to the center of gravity of the cushion 520. In other words, the sealing area 244 partially or completely surrounds the breathable placement area 238.

[0161] Similar to the cushion 454 in Figures 10A to 10F, the portion 204 that does not come into contact with the face is formed by an overmolding process along the outer periphery of the portion 202 that comes into contact with the face, along the intermediate region 206. That is, the cushion 520 includes an impregnation region 234 in which the three-dimensional knitted textile material 521 is impregnated with silicone rubber 312 along the outer periphery of the intermediate region 206 and / or the portion 202 that comes into contact with the face, within part or all of the portion 204 that does not come into contact with the face. Thus, the three-dimensional knit 521 and the impregnation region 234 only partially extend over (i.e., do not completely cover) the portion 204 that does not come into contact with the face. The unimpregnated, breathable placement region 238 of the three-dimensional knitted textile material 521 is located radially inward of the impregnation region 234. In other words, at least a portion of the outer circumference of the portion 202 that comes into contact with the face is impregnated with silicone rubber 312, while at least a portion of the inner region of the portion 202 that comes into contact with the face is not impregnated with silicone rubber 312. In some configurations, the outer circumference of the breathable placement region 238 defines the inner circumference of the impregnation region 234.

[0162] In contrast to the cushions 454 in Figures 10A to 10F, the portion 202 of the cushion 520 that contacts the face includes a three-dimensional knitted textile material 521, rather than a substantially two-dimensional sheet of the stretchable textile material 318. The two-dimensional sheet of the stretchable textile material 318 may be limited to having a predetermined three-dimensional contour determined by the geometry of the sealing area 244 when not in use. In some configurations, the three-dimensional knitted textile material 521 has such a three-dimensional contour substantially matching the geometry of the seal. Preferably, in other configurations, the three-dimensional knit of the three-dimensional knitted textile material 521 allows it to have a shape, contour, or form independent of the geometry of the sealing area 244. Thus, in some configurations, the three-dimensional knitted textile material 521 may have a three-dimensional shape such as a sock, dome, sealing tube, or various concave surfaces. Further configurations allow for customization of the three-dimensional knitted textile material 521 to adapt to the specific facial features of a particular user, thereby enhancing the comfort and airtightness of the cushion 520.

[0163] When the cushion 520 is fitted, the user's nose is pressed down against the breathable placement area 238, which is displaced toward the breathing chamber 130. The breathable placement area 238 is configured to receive the user's nose and mouth. That is, the three-dimensional knitted textile material 521 may be configured to stretch and conform to the shape of the user's nose. In some configurations, the particle orientation of the three-dimensional knitted textile material 521 is adjusted to create both highly elastic and less elastic areas across the entire three-dimensional knitted textile material 521 of the portion 202 that contacts the face. In further configurations, a highly elastic area can be positioned near the center of the breathable placement area 238 to increase adaptability for multiple users with noses of different sizes. In such configurations, the centrally located highly elastic area improves user comfort by reducing the pressure of the breathable placement area 238 on the user's nose. Preferably, due to the excellent adaptability provided by the three-dimensional knitted textile material 521 (e.g., the geometry of the seal, the textile shape independent of the high-stretch and low-stretch regions), the three-dimensional knitted textile material 521 can be easily fitted from the portion 202 that comes into contact with the face, around the outer periphery of the cushion 520, and over a portion of the portion 204 that does not come into contact with the face. Thus, the three-dimensional knitted textile material 521 helps to minimize textile wrinkles (i.e., caused by excess material) that occur around the outer periphery or portion of the portion 204 that does not come into contact with the face as a result of the overmolding process.

[0164] Figures 15A to 15D show alternative configurations of the cushion 520 for use with the CPAP system 10 of Figure 1. For the sake of brevity and convenience, explanations of certain similarities between the two configurations may be omitted herein, but such omissions are not limiting. Similar to the cushion 520 in Figures 14A and 14B, the cushion 520 comprises a portion 202 that contacts the user's face and a portion 204 that does not contact the face, interconnected by an intermediate region 206. The portion 202 that contacts the face comprises a three-dimensional knitted textile material 521, a breathable placement region 238, a sealing region 244, and an outer periphery, as described above. The portion 204 that does not contact the face comprises an impregnation region 234.

[0165] In contrast to the cushion 520 in Figures 14A and 14B, in this configuration, the three-dimensional knitted material 521 extends from the portion 202 of the cushion 520 that comes into contact with the face to the portion 204 of the cushion 520 that does not come into contact with the face, as shown in Figure 15B, and completely covers the portion 204 of the cushion 520 that does not come into contact with the face. Correspondingly, in such a configuration, the impregnation region 234 in which the three-dimensional knitted textile material 521 is impregnated with silicone rubber 312 completely covers the portion 204 that does not come into contact with the face. As shown in Figures 15B and 15D, the three-dimensional knitted textile material 521 extends from the portion 202 of the cushion 520 that comes into contact with the face to the portion 204 that does not come into contact with the face, defining the breathing chamber 130. The three-dimensional knitted textile material 521 of the portion 204 that does not come into contact with the face is overmolded with silicone rubber 312 so that the three-dimensional knitted textile material 521 of the portion 204 that does not come into contact with the face is completely impregnated with silicone rubber 312 and thus accommodated. Thus, the outermost and innermost layers of the portion that does not come into contact with the face are formed of silicone rubber 312, with the three-dimensional knitted textile material 521 embedded inside. The silicone rubber 312 in this configuration is transparent, but some configurations may utilize translucent or opaque silicone rubber 312. Thus, the portion 204 that does not come into contact with the face retains the appearance of the textile while providing a durable silicone rubber surface texture. In such embodiments, the outer surface of the silicone rubber of the portion 204 that does not come into contact with the face provides a support structure and an airtight breathing chamber 130 that allows pressurization for the supply of air to the user's airway. The impregnated region 234 may have a thickness greater than, less than, or equal to the thickness of the intermediate region 206, so that the portion 204 that does not come into contact with the face can support the portion 202 that does come into contact with the face. Thus, in this configuration, the portion 202 that comes into contact with the face maintains the comfort and fit of the breathable placement region 238 formed of the three-dimensional knitted textile material 521, while the portion 204 that does not come into contact with the face maintains the aesthetic appearance of the textile and provides a silicone rubber support structure for the cushion 520.

[0166] In some configurations, the three-dimensional knitted textile material 521 extends at least slightly beyond the impregnated area 234 so that the portion 204 that does not come into contact with the face includes an unsaturated exposed periphery 525 of the three-dimensional knitted textile material 521 around the opening of the breathing chamber 130, as shown in Figures 15B and 15C. This exposed periphery 525 of the three-dimensional knitted textile material 521 can be fixed in place by an overmolding tool 320 to prevent the three-dimensional knitted textile material 521 from becoming lumpy (e.g., wrinkled) during the overmolding process. After the overmolding process is complete, the exposed periphery 525 can be trimmed or otherwise removed. The cushion 520 also provides an overall textile appearance that offers a softer aesthetic, which may be comfortable and desirable in a bedroom environment. Furthermore, the absence of visible seams or joints in the cushion 520 results in a visually refined appearance, thereby avoiding rough edges that can be unpleasant when in contact with the user's face.

[0167] Figure 15C shows a cross-sectional view of an alternative configuration of the overmolding tool 320 for forming the cushion 520 from a three-dimensional knitted textile material 521 and liquid silicone rubber 312. Specifically, Figure 15C shows the overmolding tool 320 and the corresponding process for forming a face-contact portion 202 and a face-non-contact portion 204 from the three-dimensional knitted textile material 521, and for overmolding the liquid silicone rubber 312 onto a sealing region 244, an intermediate region 206, and the face-non-contact portion 206. A sheet of the three-dimensional knitted textile material 521 is placed on a core 528 and held (e.g., clamped) by first and second parts 526, 527 of the overmolding tool 320, which may be an openable and closable tool. The three-dimensional knitted textile material 521 conforms to the core 528 due to its three-dimensional knit as well as its highly elastic and low elastic regions. The first tool portion 526 defines the portion 202 that comes into contact with the face and a portion of the breathing chamber 130, while the second tool portion 527 defines the portion 204 that does not come into contact with the face, the opening of the breathing chamber 130, and at least a portion of the breathing chamber 130. In some configurations, the second molding tool portion 527 holds the exposed periphery 525 of the three-dimensional knitted textile material 521 in place to prevent the textile from clumping together during the molding process.

[0168] Once the three-dimensional knitted textile material 521 is fixed within the overmolding tool 320, liquid silicone rubber 312 is injected into the overmolding tool 320, via the core 528, and into the space between the core 528 and the three-dimensional knitted textile material 521. In this way, the liquid silicone rubber 312 is injected into the inner surface of the three-dimensional knitted textile material 521. While the liquid silicone rubber 312 is injected into the overmolding tool 320, the sealing region 244, the intermediate portion 206, and the impregnation region 234 of the three-dimensional knitted textile material 521 are impregnated with the liquid silicone rubber 312, leading to the cushion 520 shown in Figures 15A, 15B, and 15D. In other words, the liquid silicone rubber 312 can penetrate into specific areas of the three-dimensional knitted textile material 521 to improve the seal between the face-contacting portion 202 and the user's face, while its penetration into areas defining the breathable placement area 238 can be restricted or prohibited. In some configurations, the placement area 238 is clamped between the core 528 and the first tool portion 526 to prevent the silicone rubber 312 from flowing into the three-dimensional knitted textile material 521. In some configurations, instead of the liquid silicone rubber 312, another suitable thermoplastic elastomer (e.g., TPE) may be injected into the overmolding tool. TPE increases in density when cooled, and in some configurations, this density-increasing aspect of TPE can suppress or prevent the elastomer from completely impregnating the three-dimensional knitted textile material 521. As described above, partially impregnated textile materials are advantageous structures because they retain the feel, appearance, and other aspects of the textile that might be lost when the textile is completely saturated with liquid silicone rubber 312.

[0169] Joining textiles Figures 16A to 16C illustrate the steps for forming a cushion 530 having a portion 202 that contacts the face and has a textile outer surface, and a portion 204 that does not contact the face and has a textile outer surface. As shown in Figure 16A, a first sheet of stretchable textile material 318 is placed between a first portion 535 and a core 534 of an overmolding tool 533. A second sheet of stretchable textile material 318 is placed between the core 534 and a second portion 536 of the overmolding tool 533. The core 534 defines the breathing chamber 130 of the cushion 530. In some configurations, one or both sheets of stretchable textile material 318 may be in the form of a laminate containing one or more textile sheet layers. In some configurations, the stretchable textile material 318 may include a three-dimensional knitted textile material 521, such as a cushion 520. In other configurations, the stretchable textile material 318 may have a pre-formed three-dimensional shape. The first portion 535 defines the portion 202 of the cushion 530 that comes into contact with the face, and the second portion 536 defines the portion 204 that does not come into contact with the face. In some configurations, the portion 202 that comes into contact with the face defines an opening 134 for the mouth and nose, as shown in Figure 16C. In other configurations, the portion 202 that comes into contact with the face does not have an opening 134 for the mouth and nose, but instead has a breathable placement area 238 similar to the cushion 520 in Figures 14A and 14B, and Figures 15A to 15D.

[0170] When the first and second portions 535 and 536 of the overmolding tool 533 are clamped together around the core 534, the first and second sheets of the stretch textile material 318 are stretched (i.e., held under tension). As shown in Figure 16B, by clamping the first and second portions 535 and 536 of the overmolding tool 533 together against the core 534, the first and second sheets of the stretch textile material 318 are clamped together at their respective edges to form a seam 537. Liquid silicone rubber 312 or TPE is injected through the core 534 into the space between the core 534 and the first and second sheets of the stretchable textile material 318, so as to not penetrate completely to the outer surface of the stretchable textile material 318, but impregnates the breathable chamber side of the stretchable textile material 318, in which case the elastomer layer 538 extends continuously between the portion 202 that comes into contact with the face and the portion 204 that does not come into contact with the face, joining the first and second sheets of the stretchable textile material 318 at the seam 537. In some configurations, the TPE is injected into the overmolding tool 533 to improve control of the manufacturing process of the cushion 520 by reducing the possibility of complete impregnation of the stretchable textile material 318. Excess stretchable textile material 318 at the seam 537 is trimmed or removed from the cushion 530 after the overmolding process to obtain a clean seam as shown in Figure 16C.

[0171] Similar to the molding process described with reference to Figure 4, the amount of silicone impregnation into the stretchable textile material 318 can vary depending on the injection pressure of the liquid silicone rubber 312, the injection time, the thickness of the face-contacting portion 202 relative to the thickness of the non-face-contacting portion 204, the density of the stretchable textile material 318, and so on. Thus, the elastomer layer 538 can extend from any portion of the non-face-contacting portion 204 to the mouth and nose opening 134 of the face-contacting portion 202. In some configurations where the cushion 530 does not have a mouth and nose opening 134, the elastomer layer 538 can extend to the periphery of the face-contacting portion 202 defining the breathable placement area 238.

[0172] Figures 17A to 17C illustrate the steps for forming an alternative configuration of the cushion 530. For the sake of brevity and convenience, explanations of certain similarities between the two processes may be omitted herein, but such omissions are not limiting. Similar to the cushion 530 in Figures 16A to 16C, the cushion 530 of this embodiment comprises a face-contact portion 202 with a textile outer surface formed in an overmolding process in which liquid silicone rubber 312 or other suitable elastomer material is injected into a tool, and a non-face-contact portion 204 with a textile outer surface. As described above, the flow of liquid silicone rubber 312 or other elastomer is more easily controlled during the overmolding process in which the textile material covers the smaller portion of the cushion 530.

[0173] As shown in Figure 17A, the first sheet of the stretchable textile material 318 is positioned between the first and second parts of the first forming tool 533A. The second sheet of the stretchable textile material 318 is positioned between the first and second parts of the second forming tool 533B. The parts of the first forming tool 533A are pressed or clamped together and injected with liquid silicone rubber 312 or other suitable elastomer material to form the first sheet of the stretchable textile material 318 into the part 202 that comes into contact with the face. The parts of the second forming tool 533B are pressed or clamped together and injected with liquid silicone rubber 312 or other suitable elastomer material to form the second sheet of the stretchable textile material 318 into the part 204 that does not come into contact with the face. As shown in Figure 17B, the overmolding process preferably impregnates the inside of each sheet of the stretchable textile material 318 with an elastomer layer 538, if desired. In a further step, as shown in Figure 17B, the portion 202 that comes into contact with the face and the portion 204 that does not come into contact with the face are aligned so that the edges of portions 202 and 204 abut each other on the same plane. Then, as shown in Figure 17C, the binder 539 is applied to the inside of the portion 202 that comes into contact with the face and the portion 204 that does not come into contact with the face to interconnect the portions 202 and 204, thereby forming the cushion 530. The binder 539 may be liquid silicone rubber 312, another suitable elastomer material, or any suitable binder, and may be applied by any suitable process.

[0174] In some configurations, the portion 202 that comes into contact with the face and the portion 204 that does not come into contact with the face are joined together by an overmolding process after being removed from their respective tools 533A and 533B. During the overmolding process, the portion 202 that comes into contact with the face and the portion 204 that does not come into contact with the face are aligned within the overmolding tool so that the edges of portions 202 and 204 abut each other on the same plane, and then silicone rubber 312 or other elastomer is introduced at least inside at least areas of the portion 202 that comes into contact with the face and the portion 204 that does not come into contact with the face, adjacent to the joining edges, to interconnect the portions 202 and 204 and form a cushion 530.

[0175] The process described above realizes a cushion 530 that retains the feel and appearance of the textile on the outer surfaces of the portion 202 that comes into contact with the face and the portion 204 that does not come into contact with the face, thereby providing a soft aesthetic that can be comfortable and desirable in a bedroom environment. Furthermore, the smaller the textile component, the easier it is to control the flow of the liquid silicone rubber 312 or other elastomer during the overmolding process. In this respect, the process shown in Figures 16A to 16C is advantageous because it involves overmolding two textile components (e.g., the portion 202 that comes into contact with the face and the portion 204 that does not come into contact with the face) instead of a single larger textile component. The process shown in Figures 17A to 17C is even more advantageous in this respect because it involves overmolding the portion that comes into contact with the face and the portion that does not come into contact with the face separately, which allows for enhanced control over the flow of the liquid silicone rubber 312 or other elastomer. The processes shown in Figures 17A to 17C also provide a smooth external joint between sections 202 and 204, which is inconspicuous, visually appealing, and may be more comfortable for the user as there are no sharp or rough edges at the joint. In some configurations, the cushion 530 may comprise a face-contacting section 202 and a non-face-contacting section formed from different textile materials. Thus, the face-contacting section 202 may include a different color, material, and / or surface finish than that of the non-face-contacting section 204. In other configurations, either the section 202 or 204 can be formed using a stretchable or non-stretchable textile material 318. In configurations including a breathable placement area 238, the face-contacting section 202 may include the three-dimensional knitted textile material 521 described above.

[0176] Textile cover Figures 18A to 18D show the configuration of the cushion 540 for use with the CPAP system 10 of Figure 1. For the sake of brevity and convenience, a description of the specific similarities between cushion 540 and the cushions described above may be omitted herein, but such omissions are not limiting. Similar to cushion 510, cushion 540 comprises a portion 202 that contacts the face and a portion 204 that does not contact the face. The portion 202 that contacts the face may be attached to the portion 204 that does not contact the face (for example, by an overmolding as described above) or may be formed integrally with the portion 204 that does not contact the face. The breathing chamber 130 is defined within the internal space defined by the portion 202 that contacts the face and the portion 204 that does not contact the face. In some configurations, the portion 202 that contacts the face includes an oro-nasal opening 134 that accepts the user's nose and / or mouth, as shown in Figures 18A and 18B. The pressurized gas supplied by the conduit 120 enters the breathing chamber 130 and is received by the user through the mouth and nose opening 134. In other configurations, the portion 202 that comes into contact with the face comprises a sheet of textile material having a breathable placement area 238 through which the pressurized gas is supplied to the breathing chamber 130.

[0177] In contrast to the cushion described above, the cushion 540 includes a textile cover 541. The textile cover 541 may be a tubular or cylindrical knitted tube having a fixed end 543 and a free end 542 fixed to the cushion 540. As shown in Figures 18A and 18B, the textile cover 541 may be permanently fixed to the portion 204 that does not come into contact with the face. In some configurations, the textile cover 541 may be detachably fixed to the portion that does not come into contact with the face, so that the textile cover 541 may be replaceable or interchangeable with other parts of the cushion 540. In other configurations, as shown in Figure 18B, the textile cover 541 may be positioned along the entire or substantially entire breathing chamber 130 of the cushion 540. In some configurations, the textile cover 541 is positioned along at least 90% of the inner surface of the breathing chamber 130 and / or along all of the cushion 540 except for the rim portion surrounding the opening (e.g., opening 134 or inhalation opening). The fixed end 543 of the textile cover 541 may be overmolded to the inside of the cushion 540 (for example, the side facing the breathing chamber) using an overmolding process similar to that described above. In a further configuration, the textile cover 541 may include an elastic material such as the elastic textile material 318 described above.

[0178] The textile cover 541 is selectively movable by the user between the uncovered state shown in Figures 18A and 18B and the covered state shown in Figures 18C and 18D. In the uncovered state, the free end 542 is detached from the face-contacting portion 202 and moved toward or to the non-face-contacting portion 204, thereby exposing the face-contacting portion 202, the sealing area 244, and the non-face-contacting portion 204, as shown in Figures 18A and 18B. Preferably, in the uncovered state, the sealing area 244 can be easily cleaned independently of the textile cover 541. In some embodiments, the face-contacting portion 202 and / or the non-face-contacting portion 204 include a transparent elastomer such as silicone rubber 312, which allows portions 202 and 204 to retain the textile appearance of the fixed end 543 that covers the entire breathing chamber 130 of the cushion 540.

[0179] As shown in Figure 18B, the textile cover 541 has a length L and a diameter D. The diameter D is smaller than the height and / or width of the portion 202 that comes into contact with the face. Therefore, in the covered state, the free end 542 of the textile cover 541 must be stretched to fit over the portion 204 that does not come into contact with the face, the sealing area 244, and the portion 202 that comes into contact with the face. Once stretched over the portion 202 that comes into contact with the face, the free end 542 of the stretchable textile cover 541 will attempt to return to its diameter D, thereby holding the free end 542 in the covered state. The description of the diameter D assumes a substantially cylindrical shape with a circular cross-section. For other cross-sectional shapes, it is preferable that the free end 542 of the stretchable textile cover 541 has a height and / or width smaller than the corresponding dimensions of the portion 202 that comes into contact with the face. In the uncovered state, as shown in Figure 18B, the length L of the textile cover 541 extends outward from the breathing chamber 130 and the portion 204 that does not come into contact with the face. The length L is equal to the distance required for the textile cover 541 to completely cover the sealing area 244 and to overhang or overlap the edge or periphery of the mouth-nose opening 134 when covered, thereby providing a softer sealing surface. Thus, in the covered state, the textile cover 541 extends radially inward into the mouth-nose opening 134, forming a textile lip portion that rests on or is secured over the mouth-nose opening 134. In some configurations of the covered state, as shown in Figure 18D, the free end 542 of the textile cover 541 is pulled over the sealing area 244 and secured to the portion 202 that comes into contact with the face. In other configurations of the covered state, as shown in Figure 18C, the free end 542 is pulled around and secured to the mouth-nose opening 134. In a further configuration, the fixed end 543 of the textile cover 541 is secured to the mouth and nose opening 134 and stretched and held over the portion 204 that does not come into contact with the face when covered. Regardless of the configuration, when covered, the cushion 540 provides a seal in the sealing area 244, along with the soft feel and appearance of the textile cover 541, which has an aesthetic appearance more suitable for a bedroom environment.

[0180] Unless the context clearly indicates otherwise, throughout the description and claims, words such as “comprise” and “comprising” shall be interpreted in a comprehensive sense, rather than exclusively or exhaustively; that is, “including, but not limited to.”

[0181] No reference to prior art in this specification constitutes, nor should it be interpreted in any way as, an endorsement or suggestion that such prior art forms part of common general knowledge in any country's area of ​​focus worldwide.

[0182] The present invention can also be broadly said to consist, individually or collectively, of any combination of two or more of the parts, elements, and features referred to or indicated in the specification of this application.

[0183] Where the above description refers to a complete body or component having known equivalents, those complete bodies are incorporated herein as if they were described separately.

[0184] It should be noted that various changes and modifications to the currently preferred embodiments described herein will be obvious to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without impairing the associated advantages. For example, various components can be rearranged as needed. Accordingly, such changes and modifications are intended to fall within the scope of the invention. Furthermore, not all of the features, embodiments, and advantages are necessarily essential for carrying out the invention. Accordingly, the scope of the invention is intended to be defined solely by the appended claims below.

Claims

1. A cushion for a breathing mask, An elastomer seal structure having a part that comes into contact with the face and a part that does not come into contact with the face, Textile layer and Equipped with, The textile layer is permanently fixed to the outer surface of the portion of the elastomer seal structure that does not come into contact with the face. The textile layer further comprises one or more gaps configured to allow the textile layer to conform to the outer surface of the portion of the cushion that does not come into contact with the face, A cushion for a breathing mask, wherein one or more of the aforementioned gaps extend from the outer periphery of the textile layer to the inner periphery of the textile layer.

2. The cushion for a breathing mask according to claim 1, wherein the portion that comes into contact with the face includes an elastomer material.

3. The cushion for a breathing mask according to claim 1, wherein the textile layer comprises a non-stretchable textile.

4. The cushion for a breathing mask according to claim 1, wherein the portion in contact with the face further comprises a placement area for positioning the user's face relative to the breathing mask and a sealing area for providing a seal to the user's face, the placement area comprising a breathable continuous surface so that during use a supply of breathing gas can be provided to the user's airway through the placement area.

5. The cushion for a breathing mask according to claim 4, wherein the arrangement area includes a three-dimensional knitted textile material.

6. The cushion for a breathing mask according to claim 5, wherein the three-dimensional knitted textile material in the arrangement area comprises two or more layers.

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