Overmolded textile cushion

Abstract

To provide a cushion for a respiratory mask.SOLUTION: The 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 for providing a source of breathing gas to the user's airway during use. 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. The open cells of the open-cell foam material in the intermediate region are filled with an elastomeric material.SELECTED DRAWING: FIG. 2B

Description

[Technical Field]

[0001] The present disclosure relates generally to a seal for a respiratory interface and to an interface comprising such a seal and comprising either a mask or a mask and headgear. More particularly, certain aspects of the present disclosure relate to a cushion having a textile portion and an elastomeric portion. [Background technology]

[0002] The respiratory interface is used to deliver one or more respiratory gases under positive pressure, such as air in CPAP (or other positive pressure) therapy, to a user. 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 the pressurized gas to the user through the respiratory interface. Summary of the Invention

[0003] Preferably, the breathing interface is configured to be soft, comfortable, and lightweight when worn by a user, and to have an aesthetic that blends in with the bedroom. The breathing interface may be formed from multiple materials so that certain portions of the breathing interface provide sufficient rigidity to prevent collapse due to overtightening of the breathing interface during wear. Other portions may provide a soft feel and an aesthetic appearance that blends in with the bedroom.

[0004] The systems, methods, and devices described herein have innovative aspects, no single one of which is essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some advantageous features will now be outlined.

[0005] According to at least one embodiment disclosed herein, a cushion for a respiratory mask is provided, the cushion comprising: a face-contacting portion including an open-cell foam material, the face-contacting portion including an opening for providing a source of respiratory gas to a user's airway during use; a non-face-contacting portion including an elastomeric material; and an intermediate region formed between the face-contacting portion and the non-face-contacting portion, wherein the elastomeric material of the non-face-contacting portion is received in the open cells of the open-cell foam material in the intermediate region.

[0006] According to a further aspect, the intermediate region extends at least partially around the periphery of the cushion.

[0007] According to a further aspect, the intermediate region extends around the periphery of the cushion.

[0008] According to a further aspect, the intermediate region extends entirely around the periphery of the cushion.

[0009] According to a further aspect, the face-contacting portion comprises a mouth region and a nose region.

[0010] According to a further aspect, the nasal area is constructed from an open-cell foam material.

[0011] According to a further aspect, the nose area is constructed from a textile material.

[0012] According to a further aspect, the mouth area comprises the same material as the non-face contacting portion.

[0013] According to a further aspect, an intermediate region extends from the periphery along the face-contacting portion to the opening.

[0014] According to a further aspect, the face-contacting portion comprises a laminate material.

[0015] According to a further aspect, an open cell foam material forms part of a foam and fabric laminate material.

[0016] According to at least one embodiment disclosed herein, a cushion for a respiratory mask is provided, the cushion comprising: a face-contacting portion including a positioning region for positioning a user's face relative to the mask and a sealing region for providing a seal against the user's face; and a non-face-contacting portion, the sealing region surrounding the positioning region, the positioning region comprising a textile material.

[0017] According to a further aspect, the sealing region includes an elastomeric material.

[0018] According to a further aspect, the non-face contacting portion and the sealing area comprise the same material.

[0019] According to a further aspect, the non-face contacting material comprises a silicone material.

[0020] According to a further aspect, the sealing region includes a transition region extending between the sealing region and the positioning region.

[0021] According to a further aspect, the transition region comprises a composite material.

[0022] According to a further aspect, the transition region includes a textile material impregnated with the elastomeric material of the sealing region.

[0023] According to a further aspect, the transition region and the seal region are configured to form a seal against the user's face during use.

[0024] According to a further aspect, the positioning region comprises a breathable continuous surface such that, in use, a supply of breathing gas may be provided to the user's airway through the positioning region.

[0025] According to a further aspect, the positioning region includes a first opening configured to deliver respiratory gas to at least the nose of the patient during use.

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

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

[0028] According to a further aspect, the positioning area further comprises a mouth opening that, in use, is positioned below the nose opening.

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

[0030] According to a further aspect, the transition region is thicker than the positioning region.

[0031] According to a further aspect, the transition region projects in the thickness direction toward the interior of the cushion.

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

[0033] According to at least one embodiment disclosed herein, a cushion for a respiratory mask is provided. The cushion includes a face-contacting portion including a positioning region for positioning a user's face relative to the mask and a sealing region for providing a seal against the user's face, and a non-face-contacting portion including an elastomeric material. The positioning region is formed from a textile material, and the textile material is configured to have a predetermined three-dimensional contour shape. The sealing region is disposed around the positioning region such that the sealing region surrounds the positioning region 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 sealed region to form a predetermined three-dimensional contour shape of the textile material.

[0035] According to a further aspect, the textile material is stretchable in a single axis.

[0036] According to a further aspect, the textile material is stretchable in multiple axes.

[0037] According to a further aspect, the textile material is stretchable in two axes.

[0038] According to a further aspect, the sealing region comprises a composite material.

[0039] According to a further aspect, the composite material comprises a perimeter of stretchable textile material in the positioning region that is overmolded with the same elastomeric material as the non-face-contacting portion such that the textile is impregnated with the elastomeric material.

[0040] According to a further aspect, the cushion further comprises a stabilizing layer, the stabilizing layer including a layer of elastomeric material supporting at least a portion of the positioning area.

[0041] According to a further aspect, a stabilizing layer is disposed on the upper half of the face-contacting portion and is configured to apply a force against the patient's nose to stabilize the cushion on the patient's face during use.

[0042] According to a further aspect, the stabilizing layer extends across the nasal bridge portion of the face-contacting portion.

[0043] According to a further aspect, the stabilizing layer is separate from the textile layer.

[0044] According to a further aspect, a stabilizing layer is positioned in the bridge of the nose area.

[0045] According to a further aspect, the stabilizing layer has an outer edge attached to the inner periphery of the sealing area and a free inner edge.

[0046] According to a further aspect, the stabilizing layer includes a pair of stabilizing layers positioned on either side of the user's nose during use.

[0047] According to a further aspect, the sealing region includes a composite material and extends into the non-face-contacting portion.

[0048] According to at least one of the embodiments disclosed herein, a cushion for a respiratory mask is provided. The cushion includes a face-contacting portion and a non-face-contacting portion. At least a portion of the face-contacting portion includes a permeable material, and the non-face-contacting portion includes an elastomeric material. The permeable material portion of the face-contacting portion is joined to the non-face-contacting portion by impregnating at least a portion of the permeable material with the elastomeric material.

[0049] According to a further aspect, at least a portion of the face-contacting portion is constructed from an elastomeric material, and the permeable material portion of the face-contacting portion is joined to the non-face-contacting portion by impregnating the permeable material with the elastomeric material of the face-contacting portion.

[0050] According to a further aspect, the elastomeric material portion of the face-contacting portion is integral with the non-face-contacting portion.

[0051] According to a further aspect, the face-contacting portion comprises a positioning region and a sealing region, the sealing region surrounding the positioning region and the positioning region incorporating the permeable material portion of the face-contacting portion.

[0052] According to a further aspect, the face-contacting portion comprises a positioning region and a sealing region, the sealing region surrounding the positioning region and incorporating an elastomeric material portion of the face-contacting portion.

[0053] According to a further aspect, the entire face-contacting portion comprises a permeable material, and the face-contacting portion is joined to the non-face-contacting portion by impregnating the elastomeric material of the non-face-contacting portion with the permeable material of the face-contacting portion.

[0054] According to at least one embodiment disclosed herein, a cushion for a respiratory mask is provided, the cushion comprising an elastomeric sealing structure having a face-contacting portion and a non-face-contacting portion, and a textile layer, the textile layer being permanently secured to an outer surface of the non-face-contacting portion of the elastomeric sealing structure.

[0055] According to a further aspect, the face-contacting portion comprises an elastomeric material.

[0056] According to a further aspect, the textile layer comprises a non-stretch textile.

[0057] According to a further aspect, the textile layer further comprises slits configured to allow the textile layer to conform to an outer surface of the non-face-contacting portion of the cushion.

[0058] According to a further aspect, the face-contacting portion further comprises a positioning region for positioning a user's face relative to the mask and a sealing region for providing a seal against the user's face.

[0059] According to a further aspect, the positioning region comprises a breathable continuous surface such that, in use, a supply of breathing gas may be provided to the user's airway through the positioning region.

[0060] According to a further aspect, the textile layer extends from a positioning area of ​​the face-contacting portion to a peripheral edge of the non-face-contacting portion at a distance spaced from an opening defining an air inlet to the breathing chamber of the cushion.

[0061] According to a further aspect, the textile layer extends from a positioning area in the face-contacting portion to an exposed peripheral edge that extends outwardly past the air intake opening in the non-face-contacting portion of the cushion.

[0062] According to a further aspect, the positioning area comprises a three-dimensional knitted textile material.

[0063] According to a further embodiment, the three-dimensional knitted textile material of the positioning area comprises two or more layers.

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

[0065] According to a further aspect, the textile layer is visible from the exterior of the cushion through the elastomeric material that comprises the flexible sealing structure.

[0066] According to a further aspect, the flexible seal structure further comprises a second wall, the at least one wall and the second wall defining a breathing chamber.

[0067] According to a further aspect, the textile layer extends continuously from at least one wall to the second wall, the textile layer being contained within the second wall of the flexible seal structure.

[0068] According to a further aspect, at least one wall further comprises a positioning region for positioning a user's face against the mask and a sealing region for providing a seal against the user's face.

[0069] According to a further aspect, the positioning region comprises a breathable continuous surface such that, in use, a supply of breathing gas may be provided to at least one of the user's airways through the positioning region.

[0070] According to a further aspect, the positioning area comprises a three-dimensional knitted textile material.

[0071] According to a further embodiment, the three-dimensional knitted textile material of the positioning area comprises two or more layers.

[0072] According to at least one of the embodiments disclosed herein, a cushion for a respiratory mask is provided. The cushion comprises a flexible sealing structure having a face-contacting portion configured to seal against a user's face and a non-face-contacting portion, the sealing structure comprising an elastomeric layer, a first textile layer, and a second textile layer. The first textile layer forms at least a portion of the face-contacting portion, the second textile layer forms at least a portion of the non-face-contacting portion, and the elastomeric layer forms at least an interior portion of the face-contacting portion and the non-face-contacting portion.

[0073] According to a further aspect, the first textile layer and the second textile layer are formed from a stretch textile material.

[0074] According to a further embodiment, the stretchable textile material comprises a laminate of one or more textile sheet layers.

[0075] According to a further aspect, at least one of the first textile layer and the second textile layer is formed of a three-dimensional knit textile material.

[0076] According to a further aspect, the face-contacting portion includes an oral-nasal opening configured to receive the nose and mouth of a user.

[0077] According to a further aspect, the face-contacting portion comprises a breathable positioning area.

[0078] According to a further aspect, the first textile layer is formed from a first stretchable textile material and the second textile layer is formed from a second stretchable textile material that is different from the first stretchable textile material.

[0079] According to a further aspect, an elastomeric layer joins the first textile layer and the second textile layer at the seam.

[0080] According to a further aspect, the cushion further comprises a bonding material interposed between an inner side of the first textile layer and an inner side of the second textile layer, the bonding material joining the face-contacting portion and the non-face-contacting portion to define a breathing chamber of the cushion.

[0081] According to a further aspect, the face-contacting portion and the non-face-contacting portion define a coplanar outer surface of the non-face-contacting portion of the cushion.

[0082] According to a further aspect, the bonding material is an elastomeric material.

[0083] According to at least one of the embodiments disclosed herein, a cushion for a respiratory mask is provided. The cushion includes a flexible seal structure having a first portion configured to be positioned toward a 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 between a covering state in which the textile cover covers at least a portion of the first portion and an uncovering state in which the textile cover does not cover the first portion. The textile cover is permanently secured to the cushion.

[0084] According to a further aspect, the first portion defines a face-contacting portion of the cushion and the second portion defines a non-face-contacting portion of the cushion.

[0085] According to a further aspect, the textile cover further comprises a first end secured to the cushion and a free end opposite the first end.

[0086] According to a further aspect, the first end of the textile cover is permanently secured to the outer surface of the second portion of the cushion.

[0087] According to a further aspect, a first end of the textile cover is removably secured to an exterior surface of the second portion of the cushion.

[0088] According to a further aspect, the first and second portions of the cushion define a breathing chamber.

[0089] According to a further aspect, a textile cover is secured to at least a portion of the breathing chamber of the cushion.

[0090] According to a further aspect, the textile cover further comprises a height that is less than the height and width of the cushion.

[0091] According to a further aspect, the first portion of the cushion further comprises a sealing area configured to engage the user's face, and the textile cover further comprises a length sufficient for the free end to at least partially cover the sealing area when in the covered state.

[0092] According to a further aspect, the cushion further comprises an oral / nasal opening in a first portion of the cushion, the free end of the textile cover being configured to be secured relative to the oral / nasal opening when in the covered state.

[0093] According to a further aspect, the textile cover is formed from a stretchable textile material.

[0094] The above and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, in which the present disclosure is described with additional specificity and detail through the use of the accompanying drawings, with the understanding that these drawings illustrate only some embodiments in accordance with the present disclosure and should not be considered limiting of its scope. [Brief explanation of the drawings]

[0095] [Figure 1] FIG. 1 is a diagram of a breathing system comprising an airflow generator, a humidifier, and a user interface. [Figure 2A] FIG. 2 is a perspective view of a user interface comprising a mask and headgear suitable for use in the breathing system of FIG. 1; [Figure 2B] FIG. 2 is a side view of the user interface of FIG. 1. [Figure 3A] FIG. 2 is a perspective view of an exemplary cushion for use in the respiratory system of FIG. 1. [Figure 3B] FIG. 3B is a front view of the cushion of FIG. 3A. [Figure 3C] FIG. 3B is a rear view of the cushion of FIG. 3A. [Figure 3D] FIG. 3B is a side view of the cushion of FIG. 3A. [Figure 3E] FIG. 3B is a top view of the cushion of FIG. 3A. [Figure 3F] FIG. 3B is a bottom view of the cushion of FIG. 3A. [Figure 4A] 3A-3F are perspective views of an exemplary thermoforming tool during steps in the process of forming the cushion of FIGS. 3A-3F. [Figure 4B] 3A-3F are perspective views of an exemplary thermoforming tool and workpiece after steps in the process of forming the cushion of FIGS. 3A-3F. [Figure 4C] 3A-3F are perspective views of an exemplary overmolding tool and a portion of a cushion made from a workpiece after a step in the process of forming the cushion of FIGS. 3A-3F. [Figure 4D]3A-3F are perspective views of an exemplary overmolding tool and a portion of the cushion during steps in the process of forming the cushion of FIGS. 3A-3F. [Figure 4E] 3A-3F are perspective views of a portion of an exemplary overmolding tool during steps in the process of forming the cushion of FIGS. 3A-3F. [Figure 4F] 3A-3F are perspective views of a portion of an exemplary overmolding tool after a step in the process of forming the cushion of FIGS. 3A-3F. [Figure 5] FIG. 10 is a perspective view of an alternative exemplary cushion having a portion of the face-contacting portion formed from silicone. [Figure 6A] FIG. 10 is a perspective view of an alternative exemplary cushion having a face-contacting portion where the textile layer is completely impregnated with silicone. [Figure 6B] FIG. 6B is a front view of the cushion of FIG. 6A. [Figure 6C] FIG. 6B is a rear view of the cushion of FIG. 6A. [Figure 6D] FIG. 6B is a side view of the cushion of FIG. 6A. [Figure 6E] FIG. 6B is a top view of the cushion of FIG. 6A. [Figure 6F] FIG. 6B is a bottom view of the cushion of FIG. 6A. [Figure 7A] FIG. 10 is a perspective view of another alternative exemplary cushion having a face-contacting portion with a sealing region formed from silicone and a positioning region formed from a textile layer. [Figure 7B] FIG. 7B is a front view of the cushion of FIG. 7A. [Figure 7C] FIG. 7B is a rear view of the cushion of FIG. 7A. [Figure 7D] FIG. 7B is a side view of the cushion of FIG. 7A. [Figure 7E] FIG. 7B is a top view of the cushion of FIG. 7A. [Figure 7F] FIG. 7B is a bottom view of the cushion of FIG. 7A. [Figure 8] FIG. 10 is a perspective view of another alternative exemplary cushion having a portion of its face-contacting portion with an under-the-nose sling. [Figure 9A] FIG. 10 is a perspective view of another alternative exemplary cushion having a face-contacting portion with raised beads on its inner surface. [Figure 9B] FIG. 9B is a side cross-sectional view of the cushion of FIG. 9A. [Figure 9C] 9B is a side cutaway cross-sectional view of the cushion of FIG. 9A. [Figure 10A] FIG. 10 is a perspective view of another alternative exemplary cushion having a face-contacting portion with a breathable positioning region formed from a continuous textile surface. [Figure 10B] FIG. 10B is a front view of the cushion of FIG. 10A. [Figure 10C] FIG. 10B is a rear view of the cushion of FIG. 10A. [Figure 10D] FIG. 10B is a side view of the cushion of FIG. 10A. [Figure 10E] FIG. 10B is a top view of the cushion of FIG. 10A. [Figure 10F] FIG. 10B is a bottom view of the cushion of FIG. 10A. [Figure 11A] 10A-10F, showing the cushion before the user's nose enters the breathable positioning area. FIG. [Figure 11B] 10A-10F, showing deformation of the cushion as the user's nose penetrates the central portion of the breathable positioning area. FIG. [Figure 11C] 10A-10F, showing deformation of the cushion as the user's nose enters the upper portion of the breathable positioning area. [Figure 12A] FIG. 10 is a perspective view of another alternative exemplary cushion having a breathable positioning area formed from a continuous textile surface and a frame clip attached to a frame connection opening in the cushion. [Figure 12B] FIG. 12B is a front view of the cushion of FIG. 12A. [Figure 12C] 12B is a view of the cushion of FIG. 12A showing the bottom and front of the cushion. [Figure 13A]FIG. 10 is a front view of an alternative exemplary cushion having a non-stretch textile disposed around a non-face-contacting portion of the cushion. [Figure 13B] 13B is a rear perspective view of the cushion of FIG. 13A showing the face-contacting portion of the cushion and the mouth-nose openings. FIG. [Figure 13C] 13C is a perspective view of an exemplary overmolding tool during a step in the process of forming the cushion of FIGS. 13A and 13B. FIG. [Figure 14A] FIG. 10 is a rear perspective view of an alternative exemplary cushion having a face-contacting portion with a breathable positioning area constructed of a three-dimensional knitted textile material. [Figure 14B] FIG. 14B is a front perspective view of the cushion of FIG. 14A showing the non-face-contacting portion of the cushion. [Figure 15A] FIG. 10 is a rear perspective view of another alternative exemplary cushion having a face-contacting portion with a breathable positioning area constructed of a three-dimensional knitted textile material. [Figure 15B] 15B is a front perspective view of the cushion of FIG. 15A showing the non-face-contacting portion of the cushion, where the three-dimensional knitted textile material extends to an opening in the non-face-contacting portion of the cushion. FIG. [Figure 15C] 15A, 15B, and 15D are cross-sectional views of an overmolding tool during steps in the process of forming the cushion of FIGS. 15A, 15B, and 15D. [Figure 15D] FIG. 15C is a front perspective view of a portion of the non-face-contacting portion of the cushion of FIGS. 15A and 15B. [Figure 16A] 16B and 16C. FIG. 16C is a cross-sectional view of a forming tool during a step in the process of forming the cushion of FIGS. [Figure 16B] FIG. 16D is a cross-sectional view of a portion of the cushion of FIG. 16C. [Figure 16C] FIG. 10 is a rear perspective view of an alternative exemplary cushion having a face-contacting textile portion and a non-face-contacting textile portion. [Figure 17A] 17D and 17E are cross-sectional views of a forming tool during a step in the process of forming the cushion of FIGS. 17B and 17C. [Figure 17B] FIG. 17D is a cross-sectional view of a portion of the cushion of FIG. 17C. [Figure 17C] FIG. 10 is a rear perspective view of another alternative exemplary cushion having a face-contacting textile portion and a non-face-contacting textile portion. [Figure 18A] FIG. 10 is a side view of an alternative exemplary cushion having a face-contacting portion, a non-face-contacting portion, and an uncovered textile cover. [Figure 18B] 18B is a cross-sectional view of the cushion of FIG. 18A with the textile cover uncovered. [Figure 18C] FIG. 18B is a rear view of the cushion of FIG. 18A with the textile cover covering it. [Figure 18D] 18B is a cross-sectional view of the cushion of FIG. 18A with the textile cover covering it. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0096] Embodiments of assembly and manufacturing systems, components, and methods will now be described with reference to the accompanying drawings, wherein like numerals refer to like or similar elements throughout. While several embodiments, examples, and illustrations are disclosed below, those skilled in the art will recognize that the invention described herein extends beyond the specifically disclosed embodiments, examples, and illustrations and can include other uses of the invention and obvious modifications thereof, as well as their equivalents. Individual features of the exemplary and / or different embodiments can be combined, other embodiments can be utilized, and structural changes can be made without departing from the scope of the inventive subject matter as set forth in the claims. The terminology used in the description presented herein is not intended to be construed as limiting or restrictive simply because it is used in conjunction with detailed descriptions of certain specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature is solely responsible for its desirable attributes or is essential to practicing the invention described herein.

[0097] In the following description, certain terms may be used for reference purposes only and are not intended to be limiting. For example, terms such as "above" and "below" refer to directions in the drawings to which they refer. As used herein, the terms "front," "rear," "upper," and "lower" refer to the location of a part or portions of a respiratory mask relative to a user. Here, "front" refers to a location distal to the user (when the mask is in use), and "rear" refers to a location proximal to the user, by comparison. The terms "upper" and "lower" refer to the location 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. Additionally, 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 of similar meaning.

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

[0099] As the body of water in the chamber heats, water vapor begins to fill the chamber space above the water surface. The water vapor is supplied from a source 25, such as a blower 27, and exits the humidification chamber's outlet 13 along with an airflow that enters the humidification chamber 30 through an air inlet 26. The blower 27 can be a variable speed fan or can include a variable pressure regulator. The blower 27 draws air through an air inlet 28. The blower can be controlled, for example, by a controller 29 or the controller 18. The controller 18 or 29 can control the blower speed, regulated pressure, etc. according to any suitable criteria. For example, the controller 29 can respond to input from the controller 18 and user-set values ​​(e.g., preset values) of pressure and / or fan speed that can be set via a user interface 30 (e.g., dials).

[0100] The seals and interfaces of the present disclosure may be used in CPAP systems as described above, whether humidified or not, or alternatively in other forms of respiratory systems such as VPAP (variable positive airway pressure) systems, BiPAP (bilevel positive airway pressure), or systems with mechanical ventilation, and are generally described herein in relation to CPAP therapy by way of example only.

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

[0102] In some configurations, the interface 110 also includes a short, flexible supply conduit or tube 120 extending from the mask 112, such as from a central connection on the front of the mask 112 that connects to the supply conduit 12 of the CPAP system 10 or other respiratory 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 pivot about one or more pivot axes relative to the mask 112 so that the routing of the conduit 120 relative to the placement of the mask 112 on the user's face can accommodate the user's sleeping position. The end of the conduit 120 opposite 122 can include a suitable connector for connecting the conduit 120 to the supply conduit 12. In some configurations, the connector can be or include a swivel connector that allows relative rotation between the conduit 120 and the supply conduit 12.

[0103] As described above, the mask 112 may include a cushion 114 and a frame 116. In some configurations, the cushion 114 has a housing 124 that is coupled to the frame 116 such that the cushion 114 and the frame 116 together form an enclosure or breathing chamber with a gas inlet from the CPAP system 10 and 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 3A-3F illustrate an exemplary configuration of the cushion 114 of the mask 112 for use with the CPAP system 10 of FIG. 1. As shown, the cushion 114 includes a user's face-contacting portion 202 and a non-face-contacting portion 204. The non-face-contacting portion 204 forms a forward-facing or relatively distal portion of the partially enclosed breathing chamber 130. The face-contacting portion 204 forms a rearward-facing or relatively proximal portion of the breathing chamber 130 and is configured to engage the user's face and form a substantially airtight seal against the user's face. The face-contacting portion 202 and the non-face-contacting portion 204 are connected along their respective edges by an intermediate region 206.

[0105] The face-contacting portion 202 contacts the user's face to provide a seal that substantially surrounds the user's nose and mouth. That is, the face-contacting portion 202 is configured to engage the user's face and form a substantially airtight seal against the user's face. The face-contacting portion 202 has an oronasal opening 134 that receives the user's nose and mouth. Pressurized gas delivered by the conduit 120 enters the breathing chamber 130 and is received by the user via the oronasal opening 134.

[0106] The face-contacting portion 202 is formed from an open-cell foam material. Preferably, the face-contacting portion 202 is formed from an open-cell foam material 310 so that the portion of the cushion 114 that contacts the user's face is soft to the touch and in appearance. That is, the open-cell foam material 310 provides a comfortable, soft feel against the user's face and a comfortable, desirable appearance in a bedroom environment. The open-cell foam material 310 also provides structure and stability to the face-contacting portion 202 while being adaptable to fit different facial geometries. The open-cell foam material 310 provides a lightweight face-contacting portion 202 that reduces the overall weight of the cushion 114. A lighter cushion requires less headgear retention than a heavier cushion, thereby improving user comfort. The open-cell foam material 310 may also be breathable to allow the user's skin to breathe, thereby improving the comfort of the cushion 114. In some embodiments, the open-cell foam material 310 may be airtight or have at least some airtight regions. In other embodiments, the open cell foam material 310 can form a leak diffuser that diffuses the flow of gas leaks, preventing or suppressing spraying so that the leak is less noticeable and disruptive to the user.

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

[0108] The open-cell foam material 310 of the face-contacting portion 202 can have an outer surface 212 that contacts 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 covering that provides the outer surface 212. In some embodiments, the open-cell foam material can be in the form of a laminate including one or more textile sheet layers. In these embodiments, the textile can have a brushed, flocked, or pile / raised texture that can interlock with facial hair on the user's face. That is, the outer surface 212 can include a flocked textile. For example, Breath-o-prene® is a textile and foam laminate material with a textile outer layer.

[0109] In some configurations, the non-face-contacting portion 204 defines the housing 124 of the cushion 114. The non-face-contacting portion 204 has a frame connection opening 132 that engages with the frame 116 (see FIGS. 2A and 2B). The frame connection opening 132 provides an intake port through which a supply of pressurized air enters the breathing chamber 130. In the illustrated configuration, the non-face-contacting portion 204 is formed from a resilient thermoplastic elastomer material, such as silicone rubber 312, to provide a support structure and define the airtight breathing chamber 130, which allows for pressurization of the air delivered to the user's airway. Forming the non-face-contacting portion 204 from silicone rubber 312 allows the cushion 114 to be lightweight, flexible, and durable. Additionally, the resilient silicone structure can provide support to the face-contacting portion 202, thereby improving the ease with which the mask can be fitted to the user.

[0110] The face-contacting portion 202 is permanently bonded to the non-face-contacting portion 204 along an intermediate region 206. That is, the intermediate region 206 is disposed between the face-contacting portion 202 and the non-face-contacting portion 204. In some configurations, the intermediate region 206 may be substantially defined by the periphery and / or peripheral edge of at least one of the face-contacting portion 202 and the non-face-contacting portion 204. The face-contacting portion 202, the non-face-contacting portion 204, and the intermediate region 206 together form an enclosure or breathing chamber 130 having a gas inlet from the system 10. As described in more detail below, the non-face-contacting portion 204 is bonded to the face-contacting portion 202 along the intermediate region 206 by an overmolding process. As shown, 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 FIG. 3B. The outermost periphery of the cushion 114 is the peripheral edge between the forward-facing and rear-facing surfaces of the cushion 114. In other configurations, the intermediate region 206 may extend around the periphery of the cushion 114 that is radially inward of the outermost periphery of the cushion 114. In some configurations, the intermediate region 206 may be located on either the forward- or rear-facing surface of the cushion 114.

[0111] The intermediate region 206 includes a seam 232 and a foam and fabric laminate material-impregnated region 234. The seam 232 provides a butt joint between the open-cell foam material 310 of the face-contacting portion 202 and the silicone rubber 312 of the non-face-contacting portion 204. The seam 232 is positioned on the forward-facing surface of the cushion 114 so that the seam 232 does not contact the user's face. The butt joint forms a smooth joint (e.g., flush) without sharp edges or steps between the outer surfaces of the cushion 114. Additionally, the raw edges of the open-cell foam material 310 of the thermoformed face-contacting portion 202 are sealed by the overmolded silicone rubber 312, which provides a neat finish and prevents fraying or deterioration of the edges of the face-contacting portion 202. The impregnated region 234 is formed by impregnating the face-contacting portion 202 with silicone rubber 312 during an overmolding process, such 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 may support the face-contacting portion 202 and improve the durability of the cushion 114.

[0112] The seam 232 extends along the thickness of the edge of the face-contacting portion 202. In some configurations, the seam 232 extends around the greatest perimeter of the cushion (when viewed from the front or rear of the cushion 114) such that the seam 232 defines the perimeter of the face-contacting portion 202. In some configurations, the seam 232 may provide a smooth, seamless transition between the face-contacting portion 202 and the non-face-contacting portion 204. In other configurations, the face-contacting portion 202 and the non-face-contacting portion 204 may include ridges or protrusions that extend beyond the outer surfaces of the face-contacting portion 202 and the non-face-contacting portion 204. The seam 232 may have a constant or variable thickness along its length.

[0113] The intermediate region 206 is substantially formed from the periphery of both the face-contacting portion 202 and the non-face-contacting portion 204. The impregnated region 234 abuts the seam 232 and extends from the seam 232 into the face-contacting portion 202. That is, the periphery of the face-contacting portion 202 can be impregnated with silicone rubber 312 along the impregnated region 234. The impregnated region 234 is formed by impregnating the open-cell foam material 310 of the face-contacting portion 202 with the silicone rubber 312 during an overmolding process. That is, the impregnated region 234 is formed by allowing the overmolded silicone to penetrate 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 the silicone rubber 312. In some configurations, the fibers of the textile cover providing the outer surface 212 are saturated with the silicone rubber 312.

[0114] The impregnated region 234 extends from the forward-facing side of the cushion 114, from the seam 232, to the rearward-facing side of the face-contacting portion 202. In some embodiments, the overmolding tool can determine the shape, size, and geometry of the impregnated region 234. That is, the silicone rubber 312 can extend further into the open-cell foam material 310 in certain areas such that the impregnated region 234 is wider, deeper, and / or thicker in certain areas relative to other areas. Areas where the silicone rubber 312 extends further into the open-cell foam material 310 can be stiffer and less flexible than portions of the open-cell foam material 310 where the silicone rubber 312 extends a smaller or shallower distance into the open-cell foam material 310. The shape, size, and depth of the impregnated region 234 can be tailored to control or provide intentional leak paths and / or increase structure in certain areas of the face-contacting portion 202.

[0115] Manufacturing Process Figures 4A-4G illustrate the steps for forming cushion 114 from open-cell foam material 310 and liquid silicone rubber 312. That is, Figures 4A-4G illustrate the steps for forming face-contacting portion 202 from a sheet of open-cell foam material 310 and overmolding non-face-contacting portion 204 from liquid silicone rubber 312 onto face-contacting portion 202 to form cushion 114 of Figures 3A-3F.

[0116] As shown in FIG. 4A , an open-cell foam material 310 is disposed between first and second thermoform tool portions 302, 304 of a thermoform tool 300. The open-cell foam material 310 may be in the form of a laminate including one or more textile sheet layers. The first and second thermoform tool portions 302, 304 sandwich and compress the open-cell foam material 310 such that the open-cell foam material 310 conforms to the three-dimensional contours of the first and second thermoform tool portions 302, 304. In some configurations, a vacuum may be drawn on the first and second thermoform tool portions 302, 304 to apply a force that causes the open-cell foam material 310 to conform to the three-dimensional contours of the first and second thermoform tool portions 302, 304 and / or to draw the open-cell foam material 310 into the cavities 306 in the face-contacting portions of the first and second thermoform tool portions 302, 304. The open cell foam material 310 is heated to a forming temperature such that the open cell foam material 310 plastically deforms to conform to the geometry of the first and second thermoforming tool portions 302,304.

[0117] As shown in FIG. 4B, the open-cell foam material 310 is cooled and removed from the first and second thermoforming tool portions 302, 304. As shown, the open-cell foam material 310 is thermoformed and retains its three-dimensional contoured shape. As shown in FIG. 4C, the open-cell foam material 310 is cut to a size and shape to form the face-contacting 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-contacting portion 202, and holes are formed in the open-cell foam material 310 to provide the features of the face-contacting portion 202, such as the mouth-nose openings 134. In some configurations, the open-cell foam material 310 may be die-cut, laser-cut, or the like.

[0118] As shown in FIG. 4D, the face-contacting portion 202 is placed within an overmolding tool 320. The face-contacting portion 202 is inserted into a face-contacting cavity 326 of a first mold tool portion 322 of the overmolding tool 320. As shown in FIG. 4E, a mold tool core 324 is placed on the first mold tool portion 322 and enclosed by a second mold tool portion (not shown), and liquid silicone rubber 312 is injected under pressure into the overmolding tool 320 to mold the non-face-contacting portion 204 and further bond the face-contacting portion 202 and non-face-contacting portion 204 together. The mold tool core 324 serves as an inner core through which the liquid silicone rubber 312 flows to form the 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 vulcanizate (TPV). After injection, the liquid silicone rubber 312 is cooled and solidified. The cushion 114 is removed from the overmolding tool 320, as shown in Figure 4F.

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

[0120] The amount of silicone impregnation into the open-cell foam material 310 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, etc. 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 area of ​​the face-contacting portion 202 can be restricted via constricting or clamping the face-contacting portion 202. For example, the mold tool portion and mold tool core of the overmolding tool 320 can include areas that clamp or constrict the thickness of the open-cell foam material 310 in the face-contacting portion 202 so that the liquid silicone rubber 312 is inhibited from flowing into the open-cell foam material 310.

[0121] Partial foam and textile materials FIG. 5 illustrates an alternative configuration for a cushion 114 for use with the CPAP system 10 of FIG. 1. While certain similarities between the two configurations may be omitted herein for brevity and convenience, such omission is not limiting. The cushion 114 is comprised of a face-contacting portion 202 and a non-face-contacting portion 204. The face-contacting portion 202 is comprised of a mouth region 142 and a nose region 144. The non-face-contacting portion 204 is formed from silicone rubber 312. The face-contacting portion 202 has regions of silicone rubber 312 and / or open-cell foam material 310. More specifically, the nose region 144 of the face-contacting portion 202 is formed from open-cell foam material 310, and the mouth region 142 is formed from silicone rubber 312. Forming the nose region 144 from open-cell foam material 310 provides a soft texture to the user's nose area, which is more sensitive to pressure, while also providing the face-contacting portion 202 with an effective seal 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-contacting portion 202, which provides a strong mechanical bond between the open-cell foam material 310 and the silicone rubber 312 and may improve the durability of the cushion 114.

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

[0123] As shown, the cushion 114 has a face-contacting portion 202 comprised 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, the mouth region 142 and the non-face-contacting portion 204 are both integrally formed from the continuous silicone rubber 312. That is, the mouth region 142 and the non-face-contacting portion 204 are formed from the same material. In other configurations, the mouth region 142 and the non-face-contacting portion 204 are formed from different materials.

[0124] In some configurations, multiple continuous portions or regions of open-cell foam material 310 and / or silicone rubber 312 can be disposed around the face-contacting portion 202. For example, the face-contacting portion 202 can include a second open-cell foam material 310 disposed near a chin-contacting portion of the face-contacting portion 202. Those skilled in the art will appreciate that the regions of open-cell foam material 310 and / or silicone rubber 312 can be disposed in various regions on the face-contacting portion 202 (i.e., circumferentially, radially inward / outward, periodically, or any combination thereof, etc.) to provide the user with comfort, breathability, seal, 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 6A-6F illustrate alternative configurations of a cushion 414 for use with the CPAP system 10 of FIG. 1. While specific similarities between the two configurations may be omitted herein for brevity and convenience, such omission is not limiting. The cushion 414 is comprised of a face-contacting portion 202 and a non-face-contacting portion 204. The face-contacting portion 202 comprises a composite 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 face-contacting portion are formed from the silicone rubber 312. That is, the entire face-contacting portion 202 is comprised of textile material 310 impregnated with silicone rubber 312.

[0126] The fully impregnated textile material 310 of the face-contacting portion 202 provides the properties of both the textile material 310 and the silicone rubber 312. The face-contacting portion 202 has a textile appearance while providing the surface texture of the silicone rubber. The textile appearance may provide a softer aesthetic that may be comfortable and desirable in a bedroom environment. The textile material 310 may also have a contrasting color to the silicone rubber 312, providing an aesthetically pleasing appearance. The contrasting color may also provide a visual cue to the user regarding the positionability and fit of the cushion 414 to the user's face. The surface texture of the silicone makes the face-contacting portion airtight, and the airtight face-contacting portion 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 for pressurization of the air supply 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 regions so that airflow can be directed and / or diffused away from the user. The support structure also improves the positionability and fit of the cushion to the user's face. Additionally, the impregnated silicone rubber 312 provides an elastic structure that allows the face-contacting portion 202 to conform to various user facial geometries.

[0127] In some configurations, the non-face-contacting portion 204 may have a greater (i.e., thicker) wall thickness than the face-contacting portion 202. That is, the wall thickness of the silicone rubber 312 in the face-contacting portion 202 may be thinner than the wall thickness of the silicone rubber 312 in the non-face-contacting portion 204, such that the face-contacting portion 202 may be more flexible than the non-face-contacting portion 204. A thicker non-face-contacting portion 204 also provides greater stiffness to the housing 124 and breathing chamber 130 of the cushion 414. In some configurations, the non-face-contacting portion 204 may have a wall thickness substantially equal to that of the face-contacting portion 202.

[0128] The cushion 414 is manufactured in an overmolding tool similar to the cushion 114. In some configurations, the textile material 310 of the face-contacting portion 202 does not require thermoforming (as shown in FIG. 4A ) and trimming (as shown in FIG. 4B ) before being inserted into the overmolding tool 320. More specifically, the textile material 310 is stretched over the first mold tool portion 322 of the overmolding tool 320 before being overmolded, and the excess textile material 310 is then trimmed. In some configurations, the textile material 310 may be placed within the first mold tool portion 322 and overmolded such that the grain of the textile material 310 conforms to the curvature of the face-contacting portion 202. Orienting the grain of the textile material 310 relative to the non-face-contacting portion 204 and / or the user can improve user comfort, seal, positionability, aesthetics, etc.

[0129] Textiles and silicone impregnation bonding 7A-7F illustrate alternative configurations of a cushion 424 for use with the CPAP system 10 of FIG. 1. While certain similarities between the two configurations may be omitted herein for brevity and convenience, such omission is not limiting. As shown, the cushion 424 comprises a portion 202 that contacts the user's face and a non-face-contacting portion 204. The non-face-contacting portion 204 is formed from a thermoplastic elastomer material, such as silicone rubber 312. In some configurations, the non-face-contacting portion 204 may have a greater (i.e., thicker) wall thickness than the face-contacting portion 202. In other configurations, the non-face-contacting portion 204 may have a wall thickness that is substantially equal to the face-contacting portion 202.

[0130] The face-contacting portion 202 is comprised of a positioning region 242 and a sealing region 244. The sealing region 244 is formed from an elastomeric 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 region 244 and the non-face-contacting portion 204 may be formed from the same material. For example, both the sealing region 244 and the non-face-contacting portion 204 may be formed from silicone rubber 312. In some configurations, the sealing region 244 and the non-face-contacting portion 204 may be formed from different materials. The sealing region 244 extends around the periphery of the positioning region 242. That is, the sealing region 244 is disposed radially outward of the positioning region 242 relative to the oronasal opening 134. In other words, the sealing region 244 surrounds the positioning region 242. The sealing area 244 is integrally formed with the non-face-contacting portion 204 and may be a part of the non-face-contacting portion 204 located on the rear or user-facing side of the cushion 424 .

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

[0132] The bilayer textile material 314 of the positioning region 242 is integrally formed with the sealing region 244. That is, the periphery of the bilayer textile material 314 is overmolded onto the sealing region 244. A transition region 208 is disposed between and extends between the positioning region 242 and the sealing region 244. As shown in FIGS. 7A and 7C , the transition region 208 may be a peripheral edge between the positioning region 242 and the sealing region 244, which is disposed on the rearward, user-facing surface of the cushion 114. In some configurations, the transition region 208 may be a peripheral edge between the forward-facing and rearward-facing surfaces of the cushion 424.

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

[0134] Similar to the impregnation process described above, the impregnated region 234 is formed by impregnating the dual 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 impregnated region 234. That is, the silicone rubber 312 can penetrate certain areas of the dual layer textile material 314 to provide an impregnated region 234 shaped to improve the seal with the user's face. Similarly, the silicone rubber 312 may also be limited or inhibited from penetrating certain areas of the dual layer textile material 314 to provide an impregnated region 234 shaped to allow airflow through the positioning region 242. In some embodiments, the silicone rubber 312 in the impregnated region 234 can have a variable thickness (i.e., thicker in some areas than others).

[0135] Cushion 424 is manufactured in an overmolding tool similar to cushion 114. In some configurations, the dual layer textile material 314 of face-contacting portion 202 does not require thermoforming (as shown in FIG. 4A ) and trimming (as shown in FIG. 4B ) before being inserted into overmolding tool 320. More specifically, dual layer textile material 314 is cut and placed to size within first shape tool portion 322 of overmolding tool 320 before being overmolded.

[0136] The bilayer textile material 314 of the positioning region 242 provides a three-dimensional shape that is softer to the touch than a silicone rubber surface and provides color detail to the seal. Therefore, the cushion 424 is more comfortable against the user's face, is comfortable in a bedroom environment, and has a desirable appearance. The bilayer textile material 314 of the positioning region 242 also provides flexibility and conformability to the face-contacting portion 202 as a result of the soft nature of the bilayer textile material 314. In some configurations, the bilayer textile material 314 of the positioning region 242 may be formed such that a portion of the bilayer textile material 314 is under tension. That is, tension may be created within the bilayer textile material 314 during the overmolding process. The tension provides a degree of resilience to allow the cushion 424 to be securely positioned on the user's face.

[0137] Under-the-nose sling FIG. 8 illustrates an alternative configuration for a cushion 434 for use with the CPAP system 10 of FIG. 1. While specific similarities between the two configurations may be omitted herein for brevity and convenience, such omission is not limiting. As illustrated, the cushion 434 includes a user's face-contacting portion 202 and a non-face-contacting portion 204. The face-contacting portion 202 is comprised of a positioning region 242 and a sealing region 244. The positioning region 242 of the face-contacting portion 202 is comprised of a single-layer textile material 316 integrally formed with the sealing region 244. The periphery of the single-layer textile region 316 is overmolded to the sealing region 244. In some configurations, the positioning region 242 may include a textile material having multiple layers. In some configurations, the positioning region 242 may include a continuous surface formed from a breathable material such that a supply of respiratory gas can be provided to the user's airway through the positioning region during use.

[0138] The positioning region 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 respiratory gas to the user's mouth, and the nose opening 138 is configured to provide a supply of respiratory gas to the user's nostrils. The mouth opening 136 and the nose opening 138 form an under-nose sling 140, which is a strip of textile material that extends laterally across the face-contacting portion 202. The under-nose sling 140 is configured to be positioned under the user's nose to help position the cushion 434 on the user's face and prevent the cushion 434 from riding up on the user's face. That is, the under-nose sling 140 prevents the user's nose from sinking too deeply into the cushion 434, thereby preventing improper placement of the cushion 434. The under-the-nose sling 140 may be formed by cutting holes for the mouth opening 136 and the nose opening 138 in the single layer textile material 316. In some configurations, the under-the-nose sling 140 is defined by the mouth opening 136 and the nose opening 138.

[0139] The transition region 208 is disposed between the positioning region 242 and the sealing region 244. The transition region 208 includes a seam 232 and a textile-impregnated region 234. The seam 232 is formed by a transition from the single-layer textile material 316 of the positioning region 242 to the silicone rubber 312 of the sealing region 244. The impregnated region 234 is formed by impregnating the single-layer textile material 316 of the positioning region 242 with the silicone rubber 312 during an overmolding process, such that the positioning region 242 and the sealing region 244 are integrally formed. Thus, the transition region 208 includes a composite of the single-layer textile material 316 and the silicone rubber 312. The seam 232 extends around the periphery of the textile-impregnated region 234, providing a smooth and seamless transition between the positioning region 242 and the sealing region 244.

[0140] Textiles and silicone impregnation bonding 9A-9C illustrate an alternative configuration of a cushion 444 for use with the CPAP system 10 of FIG. 1. Description of certain similarities between the two configurations may be omitted herein for brevity and convenience, but such omission is not limiting. Similar to the cushion 434 of FIG. 8, the cushion 444 is comprised of a positioning region 242 with two openings, including a mouth opening 136 and a nose opening 138, which define an under-the-nose sling 140.

[0141] In contrast to the cushion 434 of FIG. 8 , the cushion 444 has a transition region 208 comprised of a seam 232 with a raised bead 236 on the inner surface 218 of the face-contacting portion 202. The raised bead 236 is part of the face-contacting portion 202 and extends inward toward the enclosed breathing chamber 130. As such, the seam 232 increases in thickness extending from the inner surface of the transition region toward the interior of the cushion 444. The raised bead 236 extends around the seam 232 along the periphery of the positioning region 242. The raised bead 236 extends on the interior, or inward-facing, surface 248 of the dual-layer textile material 314. FIG. 9B shows the raised bead 236 applied to a positioning region 242 formed from a single-layer textile region 316. 9C shows a raised bead 236 applied to the positioning region 242 formed from the dual layer textile region 314. The raised bead 236 is configured to enhance bond and structural strength to the seam 232. The thickness of the raised bead 236 is increased on the inner surface 218 of the face-contacting portion 202 so that the raised bead 236 does not interfere with 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 bond and structural strength while providing a comfortable surface and a substantially airtight seal against the user's face.

[0142] Silicone-impregnated textile seal area with no openings 10A-10F illustrate alternative configurations of a cushion 454 for use with the CPAP system 10 of FIG. 1. While specific similarities between the two configurations may be omitted herein for brevity and convenience, such omission is not limiting. Similar to the cushion 114 of FIG. 8, the cushion 454 includes a face-contacting portion 202 and a non-face-contacting portion 204. In contrast to the cushion 114, the cushion 454 does not have a mouth-nose opening. The face-contacting portion 202 of the cushion 454 includes a continuous, uninterrupted sheet of stretchable textile material 318 without any openings to accommodate the user's nose and / or mouth. The face-contacting portion 202 includes a breathable positioning region 238 and a sealing region 244. The breathable positioning region 238 is a porous, breathable region that allows pressurized gas in the breathing chamber 130 to be received by the user through the stretchable textile material 318. In other words, the user can breathe through the breathable positioning region 238. In some configurations, the sealing region 244 is formed from a composite material, such as a silicone rubber-impregnated open-cell foam or a textile material. In other configurations, the sealing region 244 is formed from silicone rubber 312. The sealing region 244 extends around the periphery of the breathable positioning region 238. That is, the sealing region 244 is disposed radially outward of the breathable positioning region 238 relative to the oral-nose openings 134. In other words, the sealing region 244 surrounds the breathable positioning region 238.

[0143] Similar to the cushion 114 of FIG. 8 , the non-face-contacting portion 204 is bonded to the periphery of the face-contacting portion 202 along the intermediate region 206 by an overmolding process. That is, the non-face-contacting portion 204 includes an impregnated region 234 in which the stretchable textile material 318 is impregnated with silicone rubber 312 along the periphery of the stretchable textile material 318. A breathable positioning region 238, which is not impregnated with the stretchable textile material 318, is located radially inward of the impregnated region 234. That is, the periphery of the face-contacting portion 202 is impregnated with silicone rubber 312, while the interior region of the face-contacting portion 202 is not impregnated with silicone rubber 312. The periphery of the breathable positioning region 238 is defined by the inner periphery of the impregnated region 234. As shown in FIG. 10C , the inner periphery of the impregnated region 234 and the periphery of the breathable positioning region 238 are defined by dashed lines.

[0144] The stretchable textile material 318 of the breathable positioning region 238 has a predetermined three-dimensional contour when not in use, determined at least in part by the geometry of the sealing surface. The stretchable textile material 318 is supported under tension by the sealing region 244 to form the predetermined three-dimensional contour. That is, a portion of the stretchable textile material 318 may be under tension such that the breathable positioning region 238 has a contoured shape when not in use and no force is applied to the breathable positioning region 238. The breathable positioning region 238 may be formed from a material that is stretchable in a single axis, two axes, or multiple axes. Providing an axis of stretch can determine how the breathable positioning region 238 stretches when worn by a user. In some configurations, the breathable positioning region 238 may be formed from a non-stretchable textile, foam, or laminate material.

[0145] When the cushion 454 is worn, the user's nose is pressed down against the breathable positioning region 238, which displaces the nose toward the breathing chamber 130. As shown in FIGS. 11A-11C , the absence of mouth-nose openings in the face-contacting portion 202 encourages the upper corners 222 of the face-contacting portion 202 to converge inward toward the sides of the user's nose when the user's nose is pressed down against the breathable positioning region 238. That is, as 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 forced into the breathing chamber 130 of the cushion 454, the stretchable textile material 318 pulls the upper corners 222 toward each other and into the breathing chamber 130. As the upper corners 222 are pulled toward each other, they may deform radially inward and / or collapse. This causes the sealing area 244 of the face-contacting portion 202 to pinch the sides of the user's nose, thus improving the seal between the cushion 454 and the user's face.

[0146] The breathable positioning region 238 is configured to accommodate the user's nose and mouth. That is, the stretchable textile material 318 may be configured to stretch and conform to the shape of the user's nose. In some configurations, the breathable positioning region 238 may have a certain amount of slack, looseness, or droopiness such that the breathable positioning region 238 is loose and substantially free of tension when the cushion 454 is not being worn by the user. This looseness may reduce tension in the breathable positioning region 238, thereby reducing pressure on the user's nose. In some configurations, the stretchable textile material 318 may be formed with bellows or pleats that are shaped and configured to expand when the user's nose is pressed down against the breathable positioning region 238. In other configurations, the breathable positioning region 238 may be formed from an elastic material such that the breathable positioning region 238 stretches when the user's nose is pressed down against the breathable positioning region 238. In some embodiments, the stretchable textile material 318 may include a laminate material having at least one layer that is airtight in some areas to increase the seal area 244 that contacts the user's face and improve the seal of the face-contacting portion 202.

[0147] The cushion 414 is manufactured with an overmolding tool similar to that of the cushion 114. In some configurations, the stretchable textile material 318 of the face-contacting portion 202 does not require thermoforming (as shown in FIG. 4A ) and trimming (as shown in FIG. 4B ) before being inserted into the overmolding tool 320. More specifically, the stretchable textile material 318 is a flexible sheet that is stretched over the first mold tool portion 322 of the overmolding tool 320 before being overmolded. In some configurations, a vacuum can be applied to the first and second thermoform 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 positioning region 238 can include a certain amount of slack, sagging, or droop such that the breathable positioning region 238 is loose and substantially free of tension when the cushion 454 is not being worn by a user. After the cushion 454 is overmolded with the silicone rubber 312, the excess stretch textile material 318 is trimmed at the seam 232. The overmolding tool 320 may include a blocking zone that defines and limits how much of the silicone rubber 312 flows into the stretch textile material 318. The depth of penetration into the stretch textile material 318 defines the shape of the seal area 244.

[0148] Providing slack in the breathable positioning region 238 reduces tension that may be placed on the tip of the user's nose when inserted into the cushion 414. Without slack, the textile material 318 would have to stretch over the user's nose, which could result in increased tension levels on the nose, which could be uncomfortable.

[0149] Silicone-impregnated textile sealing area with silicone stabilization layer 12A-12C illustrate an alternative configuration of a cushion 464 for use with the CPAP system 10 of FIG. 1. While specific similarities between the two configurations may be omitted herein for brevity and convenience, such omission is not limiting. Similar to the cushion 454 of FIGS. 10A-10F, the cushion 464 includes a porous, breathable, breathable positioning region 238 for a user to receive pressurized gas from the breathing chamber 130. In contrast to the cushion 454, the cushion 464 includes a stabilizing layer 246 below the stretchable textile material 318 of the face-contacting portion 202. That is, the stabilizing layer 246 is positioned between the breathing chamber 130 and the stretchable textile material 318 of the face-contacting portion 202. The stabilizing layer 246 is positioned on the upper half of the face-contacting portion 202 and is configured to apply a force against the patient's nose to stabilize the cushion on the patient's face during use.

[0150] As shown, the stabilizing layer 246 has an inverted U-shape configured to provide support to the stretch textile material 318 of the face-contacting portion 202 around the user's nasal bridge and cheek regions. That is, the stabilizing layer 246 may have an arched contour that extends between the cheek regions of the cushion 464 on both sides of the cushion 464 and over the nasal bridge region of the face-contacting portion 202. The stabilizing layer 246 increases 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 collapsing due to overtightening of the mask during wear. Thus, the stabilizing layer 246 improves the seal of the face-contacting portion 202.

[0151] The stabilizing layer 246 is formed from silicone rubber 312 and may be formed separately or integrally with the non-face-contacting portion 204. The stabilizing layer 246 is separate from and / or not attached to the stretch textile material 318. The stabilizing layer 246 has an outer edge attached to the inner periphery of the sealing region 244 and an inner edge extending into the breathing chamber 130. That is, the stabilizing layer 246 may have a first end secured to the sealing region 244 and a free second end. The stabilizing layer 246 comprises a three-dimensional layer of silicone rubber disposed under the stretch textile material 318 of the face-contacting portion 202. The stabilizing layer 246 may have a thickness greater than, less than, or equal to the thickness of the non-face-contacting portion 204. In some configurations, the stabilizing layer 246 may replace or be in addition to the impregnated 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 chin area or the upper lip area (for a 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 does not extend beyond the bridge of the user's nose.

[0152] 9B, 11B, and 11C show a frame clip 252 attached to the housing 124 of the cushions 444, 464. The frame clip 252 is a rigid ring formed from plastic that permanently attaches to the frame connection opening 132 of the housing 124. The frame clip 252 provides a removable connection between the mask frame and the cushion. The frame clip 252 may include an inner portion 254 and an outer portion 256 that are permanently joined to each other by a snap fit, a friction fit, a welded joint, or the like. The frame clip 252 provides a more reliable connection to the frame than connecting the silicone housing directly to the frame. That is, the increased rigidity of the frame clip 252 reduces the likelihood 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 13A-13C illustrate an exemplary configuration of a cushion 510 for use with the CPAP system 10 of FIG. 1. The cushion 510 includes a face-contacting portion 202 and a non-face-contacting portion 204. The non-face-contacting portion 204 forms the forward-facing or relatively distal portion of the partially enclosed breathing chamber 130, as described above. The face-contacting portion 202 forms the rearward-facing or relatively proximal portion of the breathing chamber 130 and is configured to engage and form a substantially airtight seal against the user's face. An intermediate region 206 interconnects the face-contacting portion 202 and the non-face-contacting portion 204 along their respective edges.

[0154] The face-contacting portion 202 contacts the user's face to provide a seal that substantially surrounds the user's nose and mouth. That is, the face-contacting portion 202 is configured to engage the user's face and form a substantially airtight seal against the user's face. The face-contacting portion 202 has an oronasal opening 134 that receives the user's nose and mouth. Pressurized gas delivered by the conduit 120 enters the breathing chamber 130 and is received by the user via the oronasal opening 134.

[0155] The face-contacting portion 202 may include a sealing region 244. As shown, both the face-contacting portion 202 and the sealing region 244 are formed from an elastomeric 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 oronasal opening 134). The non-face-contacting portion 204 may also be formed from silicone rubber 312. The silicone rubber 312 may be continuously disposed around or in various regions of the face-contacting portion 202 to provide comfort, a seal, flexibility, etc. to the user. In other embodiments, the face-contacting portion 202 and the non-face-contacting portion 204 may be formed from or include different materials, such as a TPE material.

[0156] The non-face-contacting portion 204 may have a dual-layer structure including a bottom or inner layer and a top or outer layer. The bottom layer may be formed of the same silicone rubber 312 or elastomeric material as the face-contacting portion 202. The top layer may be formed of a textile, such as a non-stretch textile 513, although in some configurations it may be formed of a stretch 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 approximately 70-90% nylon and 10-30% polyester woven microfiber. For example, the textile may include a blend having approximately 70% nylon and approximately 30% polyester woven microfiber, or approximately 80% nylon and approximately 20% polyester woven microfiber, or approximately 90% nylon and approximately 10% polyester woven microfiber, although other percentage configurations and other suitable textile materials may be used. A suitable non-stretchable textile 513 or stretchable textile 513 can withstand (i.e., not melt under) the high temperatures of the tools used during the curing process of the liquid silicone rubber 312. The non-stretchable textile 513 may be disposed continuously around the non-face-contacting portion 204 such that the non-face-contacting portion 204 is substantially covered by the non-stretchable textile 513. As shown in FIG. 13A , in some configurations, the non-stretchable microfiber textile 513 may be spaced from the edge of the oral-nasal opening 134. Thus, a portion of the underlying layer of the non-face-contacting portion 204 may be exposed between the non-stretchable microfiber textile 513 and the oral-nasal opening 134.

[0157] The non-stretchable textile 513 includes a textile formed of high-density fibers, such as a non-stretchable microfiber textile 513. Microfiber textiles, such as the 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 into a cavity of an 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 the non-face-contacting portion 204 of the cushion 510. The liquid silicone rubber 312 is partially forced into the fibrous structure of the user-facing side or inner side of the non-stretchable textile 513. In contrast to the fully impregnated textile material of FIGS. 6A-6F, the high-density fibrous structure of the non-stretchable textile 513 is at least partially impregnated by the flow of liquid silicone rubber 312. Instead, while attaching the non-stretch textile 513 to the underlying layer of the non-face-contacting portion 204, the silicone rubber 312 can penetrate only a portion of the thickness of the user-facing side of the non-stretch textile 513. Thus, the non-stretch textile 513 forms a front-facing textile surface 511 that is secured to the underlying layer of the non-face-contacting portion 204 but is not saturated by the silicone rubber 312 on the exposed side of the non-stretch textile 513. In some configurations, materials other than the non-stretch microfiber textile 513 can be used to form the front-facing textile surface 511, such as the Breath-o-prene® material described above. In further configurations, the Breath-o-prene® material forms all or a portion of the non-face-contacting portion 204.

[0158] As described above, the non-face-contacting portion 204 of the cushion 510 includes a forward-facing textile surface 511 that retains the texture, appearance, and other properties of the non-stretch textile 513. The non-face-contacting portion 204 is often the most prominent and visible aspect of the cushion 511 when the cushion 511 is worn by a user. Preferably, the non-stretch textile 513 includes a forward-facing textile surface 511 that retains the soft feel of the non-stretch textile 513 while providing a more comfortable and visually appealing textile aesthetic in a bedroom environment. In some configurations, the non-stretch textile 513 may also have a contrasting color to the silicone rubber 312, providing an aesthetically pleasing appearance. The contrasting color may also provide a visual cue to the user regarding the positionability 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 with other components of the CPAP mask system 10. The forward-facing textile surface 511 also protects the silicone rubber structure underlying the cushion 510 from wear and abrasion caused by the user's hands when putting on or taking off the cushion 510.

[0159] The continuous curvature of the non-face-contacting portion 204 and the non-stretchability of the non-stretchable textile 513 increase the difficulty of securing the non-stretchable textile 513 to the non-face-contacting portion 204 while obtaining the smooth (e.g., wrinkle-free) surface finish shown in FIG. 13A. As shown in FIG. 13C, the non-stretchable textile 513 may include one or more slits 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 slit 514 provides an additional degree of freedom that allows the non-stretchable textile 513 to more closely conform to the three-dimensional shape of the cushion 510. Each of the one or more slits 514 may extend from the outer periphery of the non-stretchable textile 513 to the inner periphery of the non-stretchable textile 513. Thus, the slits 514 can extend from the outer periphery of the non-stretch textile 513 to the outer periphery of the oral-nasal opening 134. In some configurations, the slits 514 may not extend the entire distance between the outer and inner peripheries of the non-stretch textile 513. In a further configuration, the non-stretch textile 513 can include slits 514 located at the bottom of the cushion 510 (e.g., near the user's chin area) to provide a cleaner aesthetic for the portion of the cushion 510 that is visible to the user during use.

[0160] Textiles and silicone impregnation bonding 14A and 14B illustrate the configuration of a cushion 520 for use with the CPAP system 10 of FIG. 1. Similar to the cushion 454 of FIGS. 10A-10F, the cushion 520 includes a face-contacting portion 202 and a non-face-contacting portion 204. The face-contacting portion 202 of the cushion 520 does not include the mouth-nose opening 134, but instead includes a continuous, uninterrupted, three-dimensional knitted textile material 521 to accommodate the user's nose and / or mouth. The face-contacting portion 202 includes a breathable positioning region 238 and a sealing region 244. The breathable positioning region 238 is a porous, breathable region that allows pressurized gas in the breathing chamber 130 to be received by the user through the stretchable textile material 521. The breathable positioning region 238 is positioned in the center of the face-contacting portion 202 to engage with and / or cover the user's nose and / or mouth. In some configurations, the sealing region 244 is formed from a composite material, such as silicone rubber 312 impregnated within the three-dimensional knitted textile material 521, to provide a comfortable surface against the user's face and a substantially airtight seal. In other configurations, the sealing region 244 is formed solely from silicone rubber 312. The sealing region 244 extends around part or all of the periphery of the breathable positioning region 238. That is, the sealing region 244 is disposed radially outward of the breathable positioning region 238 relative to the center of gravity of the cushion 520. In other words, the sealing region 244 partially or completely surrounds the breathable positioning region 238.

[0161] 10A-10F, the non-face-contacting portion 204 is formed along the periphery of the face-contacting portion 202 along the intermediate region 206 by an overmolding process. That is, the cushion 520 includes an impregnated region 234 in which a three-dimensional knitted textile material 521 is impregnated with silicone rubber 312 within part or all of the non-face-contacting portion 204 and along the periphery of the intermediate region 206 and / or the face-contacting portion 202. Thus, the three-dimensional knit 521 and the impregnated region 234 only partially extend over (i.e., do not completely cover) the non-face-contacting portion 204. An unimpregnated, breathable positioning region 238 of the three-dimensional knitted textile material 521 is disposed radially inward of the impregnated region 234. That is, at least a portion of the outer periphery of the face-contacting portion 202 is impregnated with the silicone rubber 312, and at least a portion of the interior region of the face-contacting portion 202 is not impregnated with the silicone rubber 312. In some configurations, the outer periphery of the breathable positioning region 238 defines the inner periphery of the impregnated region 234.

[0162] In contrast to the cushion 454 of FIGS. 10A-10F, the face-contacting portion 202 of the cushion 520 includes a three-dimensional knitted textile material 521 rather than a substantially two-dimensional sheet of stretch textile material 318. The two-dimensional sheet of stretch textile material 318 may be constrained to have a predetermined three-dimensional contour determined by the geometry of the seal area 244 when not in use. In some configurations, the three-dimensional knitted textile material 521 comprises such a three-dimensional contour that substantially matches the geometry of the seal. Advantageously, in other configurations, the three-dimensional knitting of the three-dimensional knitted textile material 521 allows the three-dimensional knitted textile material 521 to have a shape, contour, or form that is independent of the geometry of the seal area 244. Thus, in some configurations, the three-dimensional knitted textile material 521 may comprise a sock, a dome, a sealed tube, or various concave three-dimensional shapes. In a further configuration, the three-dimensional knitted textile material 521 can be customized to accommodate the particular facial features of a particular user, enhancing the comfort and seal of the cushion 520.

[0163] When the cushion 520 is worn, the user's nose is pressed down against the breathable positioning region 238, which is displaced toward the breathing chamber 130. The breathable positioning region 238 is configured to accommodate the user's nose and mouth. That is, the three-dimensional knitted textile material 521 can be configured to stretch and conform to the shape of the user's nose. In some configurations, the grain direction of the three-dimensional knitted textile material 521 is adjusted to create both high-stretch and low-stretch regions throughout the three-dimensional knitted textile material 521 in the face-contacting portion 202. In a further configuration, the high-stretch region can be located near the center of the breathable positioning region 238 to increase adaptability for multiple users with different nose sizes. In such a configuration, the centrally located high-stretch region improves user comfort by reducing the pressure of the breathable positioning region 238 on the user's nose. Advantageously, the excellent adaptability provided by the three-dimensional knitted textile material 521 (e.g., textile shape independent of seal geometry, high stretch regions, and low stretch regions) allows the three-dimensional knitted textile material 521 to easily conform from the face-contacting portion 202, around the periphery of the cushion 520, and over a portion of the non-face-contacting portion 204. Thus, the three-dimensional knitted textile material 521 helps minimize textile wrinkling (i.e., caused by excess material) that occurs at the periphery or portion of the non-face-contacting portion 204 as a result of the overmolding process.

[0164] 15A-15D illustrate an alternative configuration of a cushion 520 for use with the CPAP system 10 of FIG. 1. While specific similarities between the two configurations may be omitted herein for brevity and convenience, such omission is not limiting. Similar to the cushion 520 of FIGS. 14A and 14B, the cushion 520 includes a user's face-contacting portion 202 and a non-face-contacting portion 204 interconnected by an intermediate region 206. The face-contacting portion 202 includes a three-dimensional knitted textile material 521, a breathable positioning region 238, a sealing region 244, and a perimeter, as described above. The non-face-contacting portion 204 includes an impregnated region 234.

[0165] 14A and 14B, in the present configuration, the three-dimensional knitted textile material 521 extends from the face-contacting portion 202 of the cushion 520 to the non-face-contacting portion 204 of the cushion 520, as shown in FIG. 15B, completely covering the non-face-contacting portion 204 of the cushion 520. Correspondingly, in such a configuration, the impregnated region 234, where the three-dimensional knitted textile material 521 is impregnated with silicone rubber 312, completely covers the non-face-contacting portion 204. As shown in FIGS. 15B and 15D, the three-dimensional knitted textile material 521 extends from the face-contacting portion 202 to the non-face-contacting portion 204 to define the breathing chamber 130. The three-dimensional knitted textile material 521 of the non-face-contacting portion 204 is overmolded with silicone rubber 312 such that the three-dimensional knitted textile material 521 of the non-face-contacting portion 204 is completely impregnated with, and therefore encased in, the silicone rubber 312. Thus, the outermost and innermost layers of the non-face-contacting portion are formed of silicone rubber 312, with the three-dimensional knitted textile material 521 embedded therein. While the silicone rubber 312 in this configuration is transparent, some configurations may utilize translucent or opaque silicone rubber 312. Thus, the non-face-contacting portion 204 retains the appearance of a textile while providing a durable silicone rubber surface texture. In such an embodiment, the silicone rubber outer surface of the non-face-contacting portion 204 provides a support structure and an airtight breathing chamber 130 that allows a pressurized 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 non-face-contacting portion 204 can support the face-contacting portion 202. Thus, in this configuration, the face-contacting portion 202 retains the comfort and fit of the breathable positioning region 238 formed from the three-dimensional knit textile material 521, while the non-face-contacting portion 204 retains the textile aesthetic 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 region 234 such that the non-face-contacting portion 204 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 FIGS. 15B and 15C. This exposed periphery 525 of the three-dimensional knitted textile material 521 can be secured in place by the overmolding tool 320 to prevent the three-dimensional knitted textile material 521 from clumping (e.g., wrinkling) 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, providing a softer aesthetic that may be comfortable and desirable in a bedroom environment. Additionally, the lack of visible seams or joins in cushion 520 provides a visually refined appearance, thereby avoiding any harsh edges that may be uncomfortable when in contact with the user's face.

[0167] 15C shows a cross-sectional view of an alternative configuration of an overmolding tool 320 for forming a cushion 520 from a three-dimensional knitted textile material 521 and liquid silicone rubber 312. That is, FIG. 15C illustrates the overmolding tool 320 and the corresponding process for forming the face-contacting portion 202 and the non-face-contacting portion 204 from the three-dimensional knitted textile material 521 and overmolding the liquid silicone rubber 312 onto the sealing region 244, the intermediate region 206, and the non-face-contacting 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 portions 526, 527 of the overmolding tool 320, which may be an open-close tool. The three-dimensional knitted textile material 521 conforms to the core 528 due to its three-dimensional knit and high-stretch and low-stretch regions. The first tool portion 526 defines the face-contacting portion 202 and a portion of the breathing chamber 130, and the second tool portion 527 defines the non-face-contacting portion 204, 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 secures the exposed periphery 525 of the three-dimensional knit textile material 521 in place to prevent the textile from clumping during the molding process.

[0168] Once the three-dimensional knitted textile material 521 is secured within the overmolding tool 320, liquid silicone rubber 312 is injected into the overmolding tool 320, such as through the core 528, and into the space between the core 528 and the three-dimensional knitted textile material 521. In this manner, the liquid silicone rubber 312 is injected onto the inner surface of the three-dimensional knitted textile material 521. While the liquid silicone rubber 312 is being injected into the overmolding tool 320, the sealing region 244, the middle portion 206, and the impregnated region 234 of the three-dimensional knitted textile material 521 are impregnated with the liquid silicone rubber 312, resulting in the cushion 520 shown in FIGS. 15A, 15B, and 15D. That is, the liquid silicone rubber 312 can penetrate certain 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 limiting or preventing penetration into the area defining the breathable positioning region 238. In some configurations, the positioning region 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, another suitable thermoplastic elastomer (e.g., TPE) may be injected into the overmolding tool instead of the liquid silicone rubber 312. TPEs increase in density upon cooling, and in some configurations, this density-increasing aspect of TPEs can inhibit or prevent the elastomer from completely impregnating the three-dimensional knitted textile material 521. As noted above, a partially impregnated textile material is an advantageous structure because it retains the feel, appearance, and other aspects of the textile that may be lost when the textile is fully saturated with liquid silicone rubber 312.

[0169] Intertextile bonding 16A-16C illustrate steps for forming a cushion 530 including a face-contacting portion 202 with a textile outer surface and a non-face-contacting portion 204 with a textile outer surface. As shown in FIG. 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 a 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 including one or more textile sheet layers. In some configurations, the stretchable textile material 318 may include a three-dimensional knit textile material 521, such as the cushion 520. In other configurations, the stretchable textile material 318 may have a preformed three-dimensional shape. The first portion 535 defines the face-contacting portion 202 of the cushion 530, and the second portion 536 defines the non-face-contacting portion 204. In some configurations, the face-contacting portion 202 defines the mouth-nose opening 134, as shown in FIG. 16C. In other configurations, the face-contacting portion 202 does not have the mouth-nose opening 134, but instead includes a breathable positioning region 238 similar to the cushion 520 of FIGS. 14A-14B and 15A-15D.

[0170] The first and second sheets of stretchable textile material 318 are stretched (i.e., held under tension) when the first and second portions 535, 536 of the overmolding tool 533 are clamped together around the core 534. As shown in Figure 16B, clamping the first and second portions 535, 536 of the overmolding tool 533 together against the core 534 causes the first and second sheets of stretchable textile material 318 to be clamped together at their respective edges to form a seam 537. The liquid silicone rubber 312 or TPE is injected into the space between the core 534 and the first and second sheets of stretch textile material 318, such as through the core 534, without completely penetrating the outer surface of the stretch textile material 318, but instead impregnating the breath chamber side of the stretch textile material 318, such that the elastomeric layer 538 extends continuously between the face-contacting portion 202 and the non-face-contacting portion 204, joining the first and second sheets of stretch 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 for the cushion 520 by reducing the likelihood of completely impregnating the stretch textile material 318. Excess stretch textile material 318 at the seam 537 is trimmed or removed from the cushion 530 after the overmolding process to obtain the clean seam shown in FIG. 16C .

[0171] 4, the amount of silicone impregnation into the stretchable textile material 318 can vary depending on the injection pressure and injection time of the liquid silicone rubber 312, 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, etc. Thus, the elastomeric layer 538 can extend from any portion of the non-face-contacting portion 204 to the mouth-nose opening 134 in the face-contacting portion 202. In some configurations where the cushion 530 does not have the mouth-nose opening 134, the elastomeric layer 538 can extend to the periphery of the face-contacting portion 202, which defines the breathable positioning area 238.

[0172] 17A-17C illustrate steps for forming an alternative configuration of cushion 530. While explanation of certain similarities between the two processes may be omitted herein for brevity and convenience, such omission is not limiting. Similar to cushion 530 of FIGS. 16A-16C, cushion 530 of this embodiment includes face-contacting portion 202 with a textile outer surface formed in an overmolding process in which liquid silicone rubber 312 or other suitable elastomeric material is injected into a tool, and non-face-contacting portion 204 with a textile outer surface. As discussed 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 a smaller portion of cushion 530.

[0173] As shown in FIG. 17A, a first sheet of stretchable textile material 318 is placed between a first portion and a second portion of a first forming tool 533A. A second sheet of stretchable textile material 318 is placed between a first portion and a second portion of a second forming tool 533B. The portions of the first forming tool 533A are pressed or clamped together, and liquid silicone rubber 312 or other suitable elastomeric material is injected to form the first sheet of stretchable textile material 318 into the face-contacting portion 202. The portions of the second forming tool 533B are pressed or clamped together, and liquid silicone rubber 312 or other suitable elastomeric material is injected to form the second sheet of stretchable textile material 318 into the non-face-contacting portion 204. As shown in FIG. 17B, the overmolding process preferably impregnates the inside of each sheet of stretchable textile material 318 with an elastomeric layer 538, if desired. In a further step, as shown in Figure 17B, face-contacting portion 202 and non-face-contacting portion 204 are aligned so that the edges of portions 202, 204 abut one another flush. Then, as shown in Figure 17C, bonding material 539 is applied to the inside of face-contacting portion 202 and non-face-contacting portion 204 to interconnect portions 202, 204, thereby forming cushion 530. Bonding material 539 may be liquid silicone rubber 312, another suitable elastomeric material, or any suitable bonding material, and may be applied by any suitable process.

[0174] In some configurations, the face-contacting portion 202 and the non-face-contacting portion 204 are connected to one another by an overmolding process after being removed from their respective tools 533A, 533B. During the overmolding process, the face-contacting portion 202 and the non-face-contacting portion 204 are aligned in an overmolding tool so that the edges of the portions 202, 204 abut one another flush, and then silicone rubber 312 or other elastomer is introduced at least inside at least areas of the face-contacting portion 202 and the non-face-contacting portion 204 adjacent the joining edges to interconnect the portions 202, 204 and form the cushion 530.

[0175] The above-described process achieves a cushion 530 that retains the feel and appearance of a textile on the exterior surfaces of the face-contacting and non-face-contacting portions 202 and 204, thereby providing a soft aesthetic that may 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 regard, the process illustrated in FIGS. 16A-16C is advantageous because it involves overmolding two textile components (e.g., the face-contacting and non-face-contacting portions 202 and 204) instead of a single, larger textile component. The process illustrated in FIGS. 17A-17C is even more advantageous in this regard because it involves overmolding the face-contacting and non-face-contacting portions separately, allowing for enhanced control over the flow of the liquid silicone rubber 312 or other elastomer. 17A-17C also provides a smooth external joint between the portions 202, 204, which may be unobtrusive, visually appealing, and more comfortable for the user due to the lack of sharp or rough edges at the joint. In some configurations, the cushion 530 may include face-contacting and non-face-contacting portions formed from different textile materials. Thus, the face-contacting portion 202 may include a different color, material, and / or surface finish than the non-face-contacting portion 204. In other configurations, a stretchable or non-stretchable textile material 318 may be used to form either of the portions 202, 204. In configurations including the breathable positioning region 238, the face-contacting portion 202 may include the three-dimensional knit textile material 521 described above.

[0176] textile cover 18A-18D illustrate a configuration of a cushion 540 for use with the CPAP system 10 of FIG. 1. While certain similarities between the cushion 540 and cushions described above may be omitted herein for brevity and convenience, such omission is not limiting. Like the cushion 510, the cushion 540 includes a face-contacting portion 202 and a non-face-contacting portion 204. The face-contacting portion 202 may be attached to the non-face-contacting portion 204 (e.g., by overmolding, as described above) or may be integrally formed with the non-face-contacting portion 204. The breathing chamber 130 is defined within an interior space defined by the face-contacting portion 202 and the non-face-contacting portion 204. In some configurations, the face-contacting portion 202 includes an oronasal opening 134 that accommodates the user's nose and / or mouth, as shown in FIGS. 18A and 18B. Pressurized gas supplied by conduit 120 enters breathing chamber 130 and is received by the user through oral and nasal openings 134. In another configuration, face-contacting portion 202 comprises a sheet of textile material having breathable positioning areas 238 through which pressurized gas is supplied to breathing chamber 130.

[0177] In contrast to the cushions 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 secured to the cushion 540 and a free end 542. As shown in FIGS. 18A and 18B, the textile cover 541 may be permanently secured to the non-face-contacting portion 204. In some configurations, the textile cover 541 may be removably secured to the non-face-contacting portion such that the textile cover 541 may be replaceable or interchangeable with other portions of the cushion 540. In other configurations, as shown in FIG. 18B, the textile cover 541 may be disposed along the entire or substantially the entire breathing chamber 130 of the cushion 540. In some configurations, the textile cover 541 is disposed along at least 90% of the inner surface of the breathing chamber 130 and / or all but a rim portion surrounding an opening (e.g., opening 134 or air intake opening) of the cushion 540. The fixed end 543 of the textile cover 541 may be overmolded onto the inside (e.g., the side facing the breathing chamber) of the cushion 540 using an overmolding process similar to that described above. In a further configuration, the textile cover 541 may include a stretchable material, such as the stretchable textile material 318 described above.

[0178] 18A and 18B and a covered state shown in FIGS. 18C and 18D . In the uncovered state, the free end 542 is detached from the face-contacting portion 202 and moved toward or toward the non-face-contacting portion 204, thereby exposing the face-contacting portion 202, the sealing region 244, and the non-face-contacting portion 204, as shown in FIGS. 18A and 18B . Preferably, in the uncovered state, the sealing region 244 can be easily cleaned independently of the textile covering 541. In some embodiments, the face-contacting portion 202 and / or the non-face-contacting portion 204 comprises a transparent elastomer such as silicone rubber 312, which allows the portions 202, 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 FIG. 18B , the textile covering 541 has a length L and a diameter D. The diameter D is smaller than the height and / or width of the face-contacting portion 202. Thus, in the covered state, the free end 542 of the textile covering 541 must be stretched to fit over the non-face-contacting portion 204, the sealing area 244, and the face-contacting portion 202. When stretched over the face-contacting portion 202, the free end 542 of the stretchable textile covering 541 attempts to return to its diameter D, thereby maintaining 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, the free end 542 of the stretchable textile covering 541 preferably has a height and / or width smaller than the corresponding dimensions of the face-contacting portion 202. In the uncovered state, as shown in FIG. 18B , the textile cover 541 has a length L extending outward from the breathing chamber 130 and non-face-contacting portion 204. The length L is equal to the distance necessary for the textile cover 541 to completely cover the sealing area 244 and overhang or overlap the edge or periphery of the oral-nasal opening 134 in the covered state, thereby providing a softer sealing surface. Thus, in the covered state, the textile cover 541 extends radially inward into the oral-nasal opening 134 to form a textile lip that rests on or is secured to the oral-nasal opening 134. In some configurations of the covered state, the free end 542 of the textile cover 541 is pulled over the sealing area 244 and secured to the face-contacting portion 202, as shown in FIG. 18D . In other configurations of the covered state, the free end 542 is pulled around and secured to the oral-nasal opening 134, as shown in FIG. 18C . In a further configuration, the fixed end 543 of the textile cover 541 is secured to the oral / nose opening 134 and is stretched and held over the non-face-contacting portion 204 in the covered state. Regardless of the configuration, in the covered state, the cushion 540 provides the seal of the sealing area 244 along with the soft feel and appearance of the textile cover 541, which has an aesthetic that is more suited to a bedroom environment.

[0180] Unless the context clearly dictates otherwise, throughout the description and claims, the words "comprise," "comprising," and the like are to be construed in an inclusive sense, i.e., "including but not limited to," as opposed to an exclusive or exhaustive sense.

[0181] The reference in this specification to any prior art is not, and should not be construed as, an admission or in any way suggestion that that prior art forms part of the common general knowledge in the field of endeavor of any country throughout the world.

[0182] The present invention may also be broadly stated as consisting of any or all combinations of two or more of the parts, elements, and features referred to or indicated in the specification of this application, individually or collectively.

[0183] Where the above description refers to whole entities or components that have known equivalents, those whole entities are incorporated herein as if individually set forth.

[0184] It should be noted that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. For example, various components can be rearranged as desired. Accordingly, such changes and modifications are intended to be included within the scope of the present invention. Moreover, not all features, aspects, and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is intended to be defined solely by the following appended claims.

Claims

[Claim 1] 1. A cushion for a respiratory mask, comprising: a face-contacting portion comprising an open-cell foam material, said face-contacting portion comprising an opening for providing a source of breathing gas to a user's airway during use; a non-face-contacting portion comprising an elastomeric material; an intermediate region formed between the face-contacting portion and the non-face-contacting portion; Equipped with A cushion for a respiratory mask, wherein the elastomeric material in the non-face-contacting portion is received in the open cells of the open-cell foam material in the intermediate region.

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