WO2009026627A1 - Respiratory mask with textile features - Google Patents

Abstract

A patient interface includes at least one sub-component of headgear, headgear clips, frame, venting, forehead support, cushion, and elbow assembly constructed of TPE or the combination of a textile and polymer.

Description

RESPIRATORY MASK WITH TEXTILE FEATURES

CROSS REFERENCE TO APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No.

60/935,818, filed August 31, 2007, which is incorporated herein by reference in its entirety. [0002] Also, U.S. Provisional Patent Application Nos. 60/833,841, filed July 28,

2006, 60/874,968, filed December 15, 2006, 60/924,241, filed May 4, 2007, and 60/929,393, filed June 25, 2007, are incorporated herein by reference in their entirety. [0003] Also, U.S. Patent Application No. 11/578,293, filed October 13, 2006, is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0004] The present invention relates to a respiratory mask used as part of positive airway pressure (PAP) therapy for a range of conditions including sleep disordered breathing (SDB).

BACKGROUND OF THE INVENTION

[0005] The use of nasal Continuous Positive Airway Pressure (nasal CPAP) to treat

"snoring-sickness" was invented by Sullivan, e.g., see U.S. Patent No. 4,944,310. [0006] Today, there are a number of mask manufacturers including ResMed,

Respironics, and Fisher&Paykel. Known masks from ResMed include the MIRAGE nasal, MIRAGE full-face, MIRAGE SWIFT nasal pillows and the LIBERTY mask. [0007] In this patent specification, respiratory masks, including nasal pillows, prongs and so on, will be collectively referred to as "patient interfaces". [0008] A typical patient interface includes: (i) a molded hard shell or frame that defines a structure, typically constructed from polycarbonate or equivalent; (ii) a softer, flexible portion in contact with a patient's face, e.g., a silicone cushion; and (iii) an arrangement or assembly of straps or headgear, typically constructed from a polymer, or a foam and fabric laminate. [0009] At present, headgear are commonly constructed from a laminated foam and fabric material sold under the trade name of "BREATH-O-PRENE™". [0010] While nasal CPAP therapy is an effective form of treatment for sleep disorder breathing, some patients do not comply with therapy because they find it uncomfortable. There is a continued need to provide patient interfaces that patients find comfortable and effective so that they comply with therapy.

[0011] It is known to provide a one-piece integrally-formed article with portions displaying different characteristics, e.g., flexibility, resilience, hardness, colors, etc. For example, U.S. Patent No 7,052,127 discloses a one-piece integrally-formed goggle that is integrally formed by molding such that different components of the goggle have different physical characteristics, e.g., light frame members, breathable lenses, stretchable strap. [0012] Also, it is known to impregnate a fabric with a polymer. For example, U.S.

Patent No. 6,241,930 discloses a method of constructing a garment with a graphical design thereon, hi such method, a fabric garment is sandwiched in-between a die press member and a backing plate press member and a silicone polymer is injected into the die press member to fill design shaped die cavities and impregnate the fabric garment with the silicone polymer. [0013] U.S. Patent No. 6,139,787 discloses an apparatus and method for applying molded silicone design elements (e.g., three-dimensional, multi-colored, textured) onto substrates, e.g., such as fabrics. In an embodiment, the weave of the substrate is impregnated with silicone that forms molded silicone design element.

[0014] U.S. Patent No. 6,193,914 discloses an apparatus and method for molding thermosetting polymers onto substrates such as clothing.

[0015] However, such molding technology has not been applied to the respiratory therapy art, respiratory masks, or flow generators, or components thereof.

SUMMARY OF THE INVENTION

[0016] An aspect of the present invention is to provide a therapy compliance- enhancing patient interface.

[0017] Another aspect of the present invention is to provide a comfortable patient interface, hi one form, this is achieved by creating a patient interface with limited or no pressure points and with minimal disturbance to the patient and bed partner, e.g., relatively silent and no jetting of air towards the patient or bed partner's face. Air jetting is directed, high velocity air, which can cause irritation or discomfort.

[0018] Another aspect of the invention is to provide a patient interface having a nonmedical or stylish appearance, hi one form, this is achieved by creating a soft, comfortable, flexible patient interface that has the appearance of an article of clothing. [0019] Another aspect of the present invention is to provide a patient interface having an organic, subtle, sleek and sophisticated look and feel.

[0020] Another aspect of the present invention is to incorporate textile into a patient interface.

[0021] Another aspect of the invention is to provide a patient interface having visual or tactile features corresponding to a textile.

[0022] Another aspect of the invention is to mold a polymer to have the aesthetic appearance of a textile.

[0023] Another aspect of the present invention is to incorporate textile into one or more of the following features of a patient interface: headgear, frame, venting, forehead support, pad for forehead support, headgear buckles, seal and/or logos. [0024] Another aspect of the invention is to create a hollow three-dimensional fabric structure that is capable of maintaining a pressure, is biocompatible, and includes a rigidizing component.

[0025] Another aspect of the invention is to create an air delivery conduit with a textile outer layer, wherein the outer layer is constructed and arranged to be wrinkle-free. In one form, the textile has a very high elasticity.

[0026] Another aspect of the invention relates to headgear including at least one strap constructed of TPE.

[0027] Another aspect of the invention relates to a frame including a hard part and a soft part that eliminates need for a separate cushion.

[0028] Another aspect of the invention relates to a patient interface including at least one sub-component of headgear, headgear clips, frame, venting, forehead support, cushion, and elbow assembly constructed of TPE or the combination of a textile and polymer. [0029] Other aspects, features, and advantages of this invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of this invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The accompanying drawings facilitate an understanding of the various embodiments of this invention. In such drawings:

[0031] Fig. 1-1 is a cross-sectional view of a textile co-molded with a polymer;

[0032] Fig. 1 -2 is a schematic view of a textile and polymer combined by calendaring;

[0033] Fig. 1-3 is a perspective view of a substrate with a LextraMax in-mold film;

[0034] Fig. 1-4 is a perspective view of material formed by the Tecomelt process;

[0035] Fig. 1 -5 is a schematic view a textile impregnated with a polymer;

[0036] Fig. 1-6 is a schematic view of a textile having selected portions impregnated with a polymer;

[0037] Figs. 1-7 and 1-8 are perspective views of a textile impregnated with a polymer;

[0038] Fig. 1-9 A is a schematic view of a polymer injected inside out to a textile;

[0039] Fig. 1-9B is a schematic view of the polymer/textile shown in Fig. 1-9 A in an inverted configuration so that the polymer layer provides an interior surface and the textile layer provides an exterior surface;

[0040] Fig. 1-10 is a perspective view of a positive airway pressure (PAP) device having a housing with flocked portions;

[0041] Figs. 2-1 to 2-4 are various views of a patient interface including molded headgear according to an embodiment of the present invention;

[0042] Fig. 2-5 illustrates molded headgear with straps molded in a contoured shape according to an embodiment of the present invention;

[0043] Fig. 2-6 illustrates a portion of a molded headgear strap including an edge with radii according to an embodiment of the present invention;

[0044] Figs. 3-1 and 3-2 illustrate an exemplary embodiment of headgear from

ResMed's Vista mask; and [0045] Fig. 4 is a perspective view of a patient interface including at least one subcomponent constructed of TPE or the combination of a textile and polymer according to an embodiment of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

[0046] The following description is provided in relation to several embodiments which may share common characteristics and features. It is to be understood that one or more features of any one embodiment may be combinable with one or more features of the other embodiments. In addition, any single feature or combination of features in any of the embodiments may constitute additional embodiments.

[0047] In this specification, the word "comprising" is to be understood in its "open" sense, that is, in the sense of "including", and thus not limited to its "closed" sense, that is the sense of "consisting only of. A corresponding meaning is to be attributed to the corresponding words "comprise", "comprised" and "comprises" where they appear. [0048] The term "air" will be taken to include breathable gases, for example air with supplemental oxygen. It is also acknowledged that the blowers described herein may be designed to pump fluids other than air.

1. Definitions

[0049] m this specification, the term "textile" will be defined as a flexible material comprised of a network of natural or artificial fibers often referred to as thread or yarn.

Textiles are formed by weaving, knitting, crocheting, knotting, or pressing fibers together.

[0050] In this specification, the term "fabric" will be used interchangeably with textile.

[0051] In this specification, the term "polymers" will be taken to include one or more silicones, polyurethanes and thermoplastic elastomers (TPE), amongst others.

[0052] In this specification, the term "embossing" refers to the process of creating a three-dimensional image or design in paper and other ductile materials.

[0053] In this specification, in addition to in-mold decoration (IMD) and in-mold labeling (IML), in-mold lamination of decorative material is another optical and tactile finishing technique for injection molded surfaces. It allows direct in-mold lamination of grained, textile, and velour materials.

2. Processes

[0054] According to an aspect of the present invention, one or more of the following processes maybe used to create a softened, more comfortable, flexible, less "medical", more appealing, and/or low cost component for a patient interface.

[0055] For example, each illustrated embodiment includes features that may be applied to embodiments and/or components described in U.S. Provisional Patent Application

Nos. 60/833,841, filed July 28, 2006, 60/874,968, filed December 15, 2006, and 60/924,241, filed May 4, 2007, and U.S. Patent Application No. 11/578,293, filed October 13, 2006, which are incorporated herein by reference in their entirety.

2.1 Combining Polymers and Textiles

[0056] In an embodiment, a polymer and a textile may be combined to create a component for a patient interface. In an embodiment, the textile material has one or more of the following properties: soft; non-reactive with skin; not bonding, but rather mechanical linking; stretchy; thread count relatively high to stop penetration; withstand injection pressure; backing: silicone coated textile or silicone/textile lamination. [0057] The following provides one or more processes that may be utilized to combine a polymer and a textile.

[0058] For example, as shown in Fig. 1 - 1 , a textile material T may be placed in a mold M and then a polymer P (e.g., silicone) may be injected into the same mold M (e.g., co- molded) so that it bonds with the textile material T and forms a one-piece, integrated component. In such embodiment, the textile material may be a knitted material to facilitate removal of a mold core from the component, e.g., polymer/textile component sufficiently flexible to allow removal from a mold core.

[0059] In an embodiment, the polymer and textile may be combined in-mold or post- mold of the polymer. That is, the textile may be combined with the polymer during molding of the polymer into its desired shape, or the textile may be combined with the polymer after the polymer has been molded into its desired shape. [0060] In another embodiment, calendaring may be used to combine the polymer and textile. In such process, as shown in Fig. 1-2, rollers R are arranged to provide pressure for bonding the polymer P and textile T into a flat sheet, e.g., which may be cut or stamped to form headgear for example. In such embodiment, the rolled sheet may include thicker sections and thinner sections, hi another embodiment, the rolled sheet may be covered with a silicone coating.

[0061] In another embodiment, proprietary processes, e.g., Tecomelt or LextraMax, may be used to provide a component with a textile exterior surface. For example, a LextraMax fiber coating or in-mold flocking film may be provided (e.g., by lamination) to a polymer base or substrate (e.g., polycarbonate, thermoplastic polyurethane), and then inserted into a mold to provide a molded mask component (e.g., headgear) with a polymer interior surface and a textile exterior surface. Fig. 1-3 illustrates an exemplary section having a substrate constructed of a selected polymeric or elastomeric material P, and a LextraMax in- mold film L. As illustrated, the LextraMax in-mold film L includes a patented Lextra® substrate adhesive 10, patented Lextra® fibers 12, exclusive Lextra® carrier adhesives 14, and exclusive Lextra® carrier films 16.

[0062] Fig. 1-4 illustrates an exemplary section of material formed by the Tecomelt process. As illustrated, the material is a composite including fabric layers 18 and foam layers 20.

[0063] In another embodiment, as shown in Fig. 1-5, a textile or fabric T may be semi-impregnated or wholly impregnated with a polymer P (e.g., silicone (e.g., LSR)). This arrangement may provide a sealed textile airpath for a mask component. That is, the impregnated textile provides the soft appearance of textile and the sealing properties of the polymer (e.g., silicone) without the weight, hi another embodiment, a polymer (e.g., silicone) may be "screen-printed" onto a textile and then thermoformed and cured in a Carver press. [0064] hi another embodiment, as shown in Fig. 1-6, a polymer P maybe impregnated into selected portions of the textile T such that portions of the textile are exposed. This arrangement may provide a relatively quiet textile vent, hi an embodiment, such a textile vent may be formed as a grommet so that it may be removably incorporated into a patient interface. [0065] Figs. 1 -7 and 1 -8 are additional views of a textile impregnated with a polymer, e.g., silicone, wherein the textile T provides an exterior surface of the component. As best shown in Fig. 1 -7, a portion of the textile may be devoid of a polymer, e.g., to provide a vent portion V.

[0066] In another embodiment, the polymer may be partially or fully encapsulated by the textile. For example, in in-mold encapsulation, the polymer permeates through the thickness of the textile.

[0067] In another embodiment, the polymer may be combined with the textile by a process between lamination and encapsulation. In such process, the polymer infuses or permeates through a portion of the thickness of the textile, e.g., half the thickness.

[0068] In another embodiment, the polymer and textile may be combined in a manner that makes it look conspicuously like a seam (e.g., like a material stitched together). For example, portions of the mask component may be glued together to form the desired shape of the mask component, but then embossed to make it look like it was stitched.

[0069] In another embodiment, one or more edges of the fabric material may be folded over to create a seam or seal.

[0070] hi another embodiment, a water assist or gas assist process may replace the normal core to blow or force the polymer (e.g., silicone) against the side wall of the molding tool.

[0071] In another embodiment, a vacuum may be provided to hold a textile in a mold as a polymer (e.g., silicone) is injected into the same mold so that it can bond with the textile. hi an embodiment, the fabric may be relatively impermeable, e.g., to prevent the polymer from bleeding through the textile.

[0072] hi another embodiment, textile may be held tight or clamped between different parts of the mold as a polymer is injected into the same mold, hi such embodiment, post processing may be provided to remove fabric "flash".

[0073] hi another embodiment, a heat process may be applied to the textile to stiffen and seal the textile.

[0074] In another embodiment, as shown in Fig 1-9 A, a polymer may be injected from an inner side of a textile T towards an outer side of the textile, e.g., inject from inside out as indicated by the arrows, and form a polymer layer P on the outer side of the textile T. Following injection molding, the component may be inverted so that the component provides the polymer layer P as an interior surface and the textile layer T as an exterior surface, as shown in Fig. 1-9B.

2.2 Post-molding Steps

[0075] In an embodiment, the mask component may be constructed of fabric/textile sheet and/or laminated fabric/textile sheet, and then sewn, welded, and/or glued to form the desired shape of the component. In embodiments, the component does not need to be completely air tight, just sufficiently air tight to supply air at therapeutic pressure. [0076] In an embodiment, the mask component may be constructed of a number of pieces that are sewn, welded, glued, or otherwise bonded together to form the desired shape of the component.

2.3 Coating Techniques

[0077] In an embodiment, a polymer and a textile may be combined using a coating technique.

[0078] For example, a textile material may coated with a coating (e.g., first silicone coating), placed in a mold, and then a polymer (e.g., a different silicone) may be injected into the same mold (e.g., co-molded) and bond with the textile coating. [0079] Known techniques (e.g., from Dow Corning document dated 2004) for the application of silicone coatings to textile or fabric include: (i) knife coating (e.g., knife-over- roll, knife-over-gap/air or knife-over-blanket): outcome may be influenced by blade type and angle as well as the substrate; (ii) dip/immersion coating or kiss coating (e.g., lick roll); (iii) rotogravure coating: the gravure process ensures that the topcoat is delivered at a constant application rate and is not affected by substrate variability, and such process may facilitate higher line speeds; (iv) extrusion; and (v) spraying.

2.4 Simulating the Appearance or Tactility of a Textile

[0080] One or more of the following processes may be used to simulate the appearance or tactility of a textile, which may create a softened, less "medical", and/or more appealing mask component. [0081] For example, the mask component may be molded of a polymer material, and one or more sides or portions of the polymer mask component maybe molded or treated in a manner to simulate the appearance or tactility of a textile.

[0082] For example, the polymer material (e.g., silicone) may be impregnated with textile fibers to simulate the visual appearance of a textile.

[0083] In another embodiment, the mask component may be molded out of an opaque material and then a contrasting color may be overmolded to the opaque material. Images and/or indicia may be provided (e.g., printed) to the contrasting color.

[0084] In another embodiment, one or more components of the patient interface may be flocked (e.g., process in which individual cut fiber particles are deposited onto the surface of a component), hi such embodiment, each flocked component may be partially or fully flocked, e.g., portions not being flocked may be masked or covered. For example, a mask component may be molded out of a plastic material and the impression of textile may be created through flocking and/or in-mold decoration to impart the appearance of textiles.

[0085] Fig. 1-10 illustrates a positive airway pressure (PAP) device or flow generator

22 having a housing 24 (e.g., constructed of a plastic material) with flocked portions 26 to add tactile appeal to relatively hard plastic parts.

[0086] In another embodiment, embossing may be applied to the mask component, e.g., post-molding.

[0087] hi another embodiment, the mold may include a mold surface structured to provide the appearance of texture to the molded component, e.g., surface of molded component is textured to mimic textile.

[0088] hi another embodiment, the surface of the component may be chemically treated or etched to simulate the visual appearance of a textile.

[0089] m another embodiment, a layer of foam may be applied as a surface coating to the mask component.

[0090] Li another embodiment, foaming inks, puff paint, and/or an ironing process to cause puffing at the surface may be applied to the component so that one or more portions of the component stand out at the surface.

[0091] Li another embodiment, screen printing may be applied to the surface of the mask component. [0092] In another embodiment, synthetic suede or other suitable textile material may be provided to the mask component post molding. For example, synthetic suede or other suitable textile material may be adhered to the mask component with a pressure sensitive adhesive, e.g., silicone.

3. Headgear

3.1 Molded Headgear

[0093] One aspect of the present invention relates to low cost headgear molded from a thermoplastic elastomer (TPE), such as SANTOPRENE™ or TPE Kraton 27A30. In an embodiment, the headgear may be cut or stamped (e.g., with a stamping die) from flat, molded sheets of TPE. hi another embodiment, TPE may be injected into a mold that forms the desired shape of the headgear.

[0094] Such molded headgear may be considerably cheaper than conventional designs, e.g., headgear constructed of fabric or textile. In addition, molded headgear may provide shorter lead times and a faster response to extra demands, hi an embodiment, the molded headgear maybe recyclable, e.g., TPE is of a recyclable grade. [0095] Figs. 2-1 to 2-4 illustrate a patient interface 30 including molded headgear according to an embodiment of the present invention. As illustrated, the patient interface 30 includes a frame 32, a cushion 34 provided to the frame 32 and adapted to form a soft, compliant seal with the patient's face, an inlet conduit 36 provided to the frame 32 and adapted to be connected to an air delivery tube 38 that delivers breathable gas to the patient, and a forehead support 40 to provide a support and stability mechanism between the patient interface 30 and the patient's forehead. The headgear 42 is adapted to be removably attached to the frame 32 and the forehead support 40 to maintain the patient interface in a desired position on the patient's face.

[0096] hi the illustrated embodiment, the headgear 42 includes a pair of side portions

43 and a rear portion 45 that interconnects the pair of side portions 43. Each of the side portions 43 includes an upper side strap 44 adapted to removably attach to the forehead support 40 and a lower side strap 46 adapted to removably attach to the frame 32. The rear portion 45 includes an upper strap 48, a lower strap 50, and intermediate connecting straps 52 extending between the upper strap 48 and the lower strap 50. As illustrated, the straps form upper and lower openings 54, 56 (e.g., see Fig. 2-2), e.g., to allow material rolling, accommodate skin folds, etc.

[0097] While the headgear is described as being used with a patient interface of the type described above, it may be adapted for use with other suitable patient interfaces. That is, the patient interface is merely exemplary, and aspects of the headgear may be adapted for use with any suitable patient interface, e.g., a full-face (oro-nasal) mask, a mouth (oro) mask, or a nasal mask. For example, the headgear (molded of TPE) may include other suitable strap arrangements or configurations suitable to maintain a patient interface in a desired position on the patient's face.

[0098] Additional benefits of molded headgear include one or more of the following: provides a reliable and consistent component, e.g., no delamination problems, less operator errors; provides shorter cycle time, e.g., easy to increase the numbers; can be molded in a contoured or rounded shape for ease of use (e.g., Fig. 2-5 illustrates molded headgear 130 similar to headgear 30 described above with the straps molded in a contoured or rounded shape to better conform with the contours of the patient's head in use); possibility of over- molding to produce headgear similar to ResMed's Vista headgear (e.g., Figs. 3-1 and 3-2 illustrate an exemplary embodiment of headgear 230 from ResMed's Vista mask disclosed in U.S. Patent No. 6,907,882, which is incorporate herein by reference in its entirety); sections may be varied (e.g., very thickness or width) to vary the elasticity; and/or patterns, different colors, and/or text can be added.

[0099] In an embodiment, edges of the headgear straps may have radii molded therein, e.g., 0.1 mm, to reduce the likelihood of the headgear leaving a mark on the skin of a patient. For example, Fig. 2-6 illustrates a portion of a molded headgear strap including an edge with radii r.

[00100] In another embodiment, a textured finish may be applied to an inside surface of the headgear (e.g., during molding of the headgear) to improve the feeling of the headgear on the patient's skin, e.g., improve "grip". The textured surface may also be applied to an outside surface of the headgear to improve grip, e.g., for adjustment. [00101] In another embodiment, the headgear straps may include features to allow or improve the "breathability" of the straps, e.g., to aid the flow of moisture from the patient's skin. Such features may include holes, grooves and/or other textured finish on the straps. For example, a textured finish or surface may be provided to an inside surface of the strap to lift the strap off the patient's skin to improve breathability.

[00102] In an embodiment, the side straps of the headgear may be attached to the frame/forehead support using cam fasteners and/or tabs/hooks molded with the straps.

3.2 Conduit Headgear

[00103] Another aspect of the present invention relates to conduit headgear constructed from the combination of a textile and polymer. Exemplary conduit headgear is disclosed in

U.S. Provisional Patent Application Nos. 60/833,841, filed July 28, 2006, 60/874,968, filed

December 15, 2006, and 60/924,241, filed May 4, 2007, and U.S. Patent Application No.

11/578,293, filed October 13, 2006, which are incorporated herein by reference in their entirety.

[00104] For example, a textile material may be placed in a mold and then a polymer

(e.g., silicone) maybe injected into the same mold (e.g., co-molded) so that it bonds with the textile material and forms a one-piece, integrated conduit headgear structure with a textile exterior surface and a polymer interior surface.

[00105] In an embodiment, a secondary process may be used to incorporate an open channel into the conduit headgear.

[00106] Li another embodiment, a seam may be created in the component that can be mechanically joined to form the desired shape of the conduit headgear.

4. Patient Interface Sub-Components

[00107] Another aspect of the present invention relates to a patient interface wherein at least one of its sub-components (e.g., headgear, headgear clips or buckles, frame, venting, forehead support, cushion or seal, company logos, etc.) is constructed of TPE or the combination of a textile and polymer.

[00108] For example, Fig. 4 illustrates a patient interface 330 (e.g., full-face mask assembly) including a frame 332, a cushion 334 provided to the frame 332 and adapted to form a seal with the patient's face, an elbow assembly 336 provided to the frame 332 and adapted to be connected to an air delivery tube that delivers breathable gas to the patient, and a forehead support 340 to provide a support and stability mechanism between the patient interface and the patient's forehead. Headgear (not shown) may be removably attached to the frame 332 via clips 333 and to the forehead support 340 via cross-bars 341, for example. The frame 332 includes venting or a vent assembly 335 for gas washout.

[00109] Further details and embodiments of this type of patient interface are disclosed in U.S. Provisional Application No. 60/858,700, filed November 14, 2006, and International Publication Nos. WO 2007/045008, published April 26, 2007, WO 2007/041751, published April 19, 2007, and WO 2006/074517, published July 20, 2006, each of which is incorporated herein by reference in its entirety.

[00110] Li an embodiment of the present invention, at least one of the frame 332, cushion 334, elbow assembly 336, forehead support 340, clips 333, and vent assembly 335 may be constructed of TPE or the combination of a textile and polymer as described above.

[00111] While the invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. Also, the various embodiments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment maybe combined with aspects of another embodiment to realize yet other embodiments. Further, each independent feature or component of any given assembly may constitute an additional embodiment. In addition, while the invention has particular application to patients who suffer from OSA, it is to be appreciated that patients who suffer from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike in non-medical applications.

Claims

CLAMS:

1. Headgear comprising at least one strap constructed of TPE.

2. Headgear according to claim 1 , wherein TPE includes S ANTOPRENE™ or TPE Kraton 27A30

3. Headgear according to any one of claims 1 -2, wherein at least one strap is constructed of textile.

4. A frame comprising a hard part and a soft part that eliminates need for separate cushion.

5. A patient interface comprising at least one sub-component of headgear, headgear clips, frame, venting, forehead support, cushion, and elbow assembly constructed of TPE or the combination of a textile and polymer.

6. A patient interface according to claim 5, wherein the sub-component is the headgear.

7. A patient interface according to any one of claims 5-6, wherein the subcomponent is the headgear clips.

8. A patient interface according to any one of claims 5-7, wherein the subcomponent is the frame.

9. A patient interface according to any one of claims 5-8, wherein the subcomponent is the venting.

10. A patient interface according to any one of claims 5-9, wherein the subcomponent is the forehead support.

11. A patient interface according to any one of claims 5-10, wherein the subcomponent is the cushion.

12. A patient interface according to any one of claims 5-11 , wherein the subcomponent is the elbow assembly.