HEADGEAR FOR INFANT RESPIRATORY THERAPY INTERFACE

A patient interface assembly includes a patient interface configured to deliver breathing gases to the airway of a patient. A headgear is configured to support the patient interface on the head of a patient. The headgear can include a tab on each side configured to overlie the patient's cheek and forming a portion or an entirety of an attachment region for the patient interface. The tab can be angled relative to an adjacent portion of the headgear. In some configurations, the headgear includes a rear portion having a first degree of stretch and/or a front portion having a second degree of stretch. In some configurations, the headgear also includes a chinstrap having a third degree of stretch. In some configurations, the third degree of stretch is greater than the first degree of stretch and the second degree of stretch.

BACKGROUND

Field

The present disclosure relates to respiratory interface assemblies. In particular, the present disclosure relates to headgear for respiratory interface assemblies.

Description of Related Art

In assisted breathing, respiratory gases are supplied to a patient through a patient interface via one or more flexible breathing tubes. The patient interface can be a nasal cannula, nasal mask, full face or oro-nasal mask, endotracheal tube, or other known types of interfaces. The patient interface is held in place on the head of the user by a suitable support structure. In some configurations, the patient interface is supported on the user by an adhesive connection with the user's face. However, in other configurations, a headgear arrangement may be preferable for use instead of or in addition to an adhesive connection.

SUMMARY

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

An aspect of the present disclosure involves a headgear for a respiratory interface, including a rear portion having a first degree of stretch, a front portion having a second degree of stretch, and a chinstrap having a third degree of stretch. The third degree of stretch is greater than the first degree of stretch and the second degree of stretch.

In some configurations, the first degree of stretch is substantially non-stretch.

In some configurations, the second degree of stretch is substantially non-stretch.

In some configurations, the third degree of stretch is sufficient to allow a patient to open his or her mouth.

In some configurations, the chinstrap is detachable from one or both of the front portion and the rear portion.

In some configurations, the chinstrap attaches to the front portion.

In some configurations, the chinstrap comprises a first part of a releasable connection and the front portion comprises a second part of the releasable connection, wherein the releasable connection can include but is not limited to a hook and loop fastener, a magnetic fastener, a post and aperture connection, a releasable adhesive, or an interlocking buckle or clip.

In some configurations, the chinstrap is attachable to the front portion such that an effective length of the chinstrap is adjustable.

In some configurations, the chinstrap is a stretch component.

In some configurations, the chinstrap and/or the front portion are configured for attachment to a respiratory interface.

In some configurations, the chinstrap comprises a bifurcated portion, a chin cup and/or a chin gripper configured to be located at a chin of a user.

In some configurations, the front portion is flexible in torsion.

In some configurations, a length of the front portion is adjustable.

In some configurations, the front portion comprises a first strap portion and a second strap portion configured to connect to one another along an overlapping portion, wherein a length of the overlapping portion is variable to permit adjustment of the length of the front portion.

In some configurations, the first strap portion comprises an opening and the second strap portion passes through the opening.

In some configurations, a length of the rear portion is adjustable.

In some configurations, each side of the front portion comprises a buckle, wherein each of a first end and a second end of the rear portion passes through a respective one of the buckles, folds back on itself and attaches to itself.

In some configurations, the rear portion comprises an increased width central portion having a pattern of cutouts.

In some configurations, the pattern of cutouts of the increased width central portion defines a first ellipse and a second ellipse within the first ellipse.

In some configurations, the rear portion comprises a midline strap configured to extend over the top of a head of a user in a forward-rearward direction and attach to the front portion.

In some configurations, the headgear further comprises a notch on each side of the midline strap where the midline strap originates from the rear portion.

In some configurations, the headgear further comprises an attachment region configured to support the respiratory interface.

In some configurations, the attachment region comprises a first part of a releasable connection that is configured to connect to a second part of the releasable connection on the respiratory interface, wherein the releasable connection can include but is not limited to a hook and loop fastener, a magnetic fastener, a post and aperture connection, are leasable adhesive, or an interlocking buckle or clip.

In some configurations, the attachment region comprises a first portion and a second portion, wherein the first portion and the second portion define an angle therebetween.

In some configurations, the angle is between about 110-160 degrees, such as about 140 degrees.

In some configurations, the second portion comprises an attachment tab.

In some configurations, the second portion is configured to be located on the patient's cheek region in use.

An aspect of the present disclosure involves a headgear for a respiratory interface, including a front portion having a first degree of stretch and a chinstrap having a second degree of stretch. The second degree of stretch is greater than the first degree of stretch.

In some configurations, the first degree of stretch is substantially non-stretch.

In some configurations, the second degree of stretch is sufficient to allow a patient to open his or her mouth.

In some configurations, the chinstrap is detachable from the front portion.

In some configurations, the chinstrap comprises a first part of a releasable connection and the front portion comprises a second part of the releasable connection, wherein the releasable connection can include but is not limited to a hook and loop fastener, a magnetic fastener, a post and aperture connection, a releasable adhesive, or an interlocking buckle or clip.

In some configurations, the chinstrap is attachable to the front portion such that an effective length of the chinstrap is adjustable.

In some configurations, the chinstrap is a stretch component.

In some configurations, the chinstrap and/or the front portion are configured for attachment to a respiratory interface.

In some configurations, the chinstrap comprises a bifurcated portion, a chin cup and/or a chin gripper configured to be located at a chin of a user.

In some configurations, the front portion is flexible in torsion.

In some configurations, a length of the front portion is adjustable.

In some configurations, the front portion comprises a first strap portion and a second strap portion configured to connect to one another along an overlapping portion, wherein a length of the overlapping portion is variable to permit adjustment of the length of the front portion.

In some configurations, the first strap portion comprises an opening and the second strap portion passes through the opening.

In some configurations, the headgear includes a rear portion.

In some configurations, the headgear further comprises an attachment region configured to support the respiratory interface.

In some configurations, the attachment region comprises a first part of a releasable connection that is configured to connect to a second part of the releasable connection on the respiratory interface, wherein the releasable connection can include but is not limited to a hook and loop fastener, a magnetic fastener, a post and aperture connection, a releasable adhesive, or an interlocking buckle or clip.

In some configurations, the attachment region comprises a first portion and a second portion, wherein the first portion and the second portion define an angle therebetween.

In some configurations, the angle is between about 110-160 degrees, such as about 140 degrees.

In some configurations, the second portion comprises an attachment tab.

In some configurations, the second portion is configured to be located on the patient's cheek region in use.

An aspect of the present disclosure involves a patient interface assembly including a patient interface configured to deliver breathing gases to the airway of a patient. The patient interface assembly includes a headgear configured to support the patient interface. The headgear includes a chinstrap and a front portion. The patient interface system includes an interface securement system comprising a two-part connection. A first part of the two-part connection is located on the chinstrap or the front portion and a second part of the two-part connection is located on the patient interface.

In some configurations, the patient interface is a sealing interface that contacts and creates a seal with a face of the patient.

In some configurations, the patient interface is a mask or a cannula.

In some configurations, the patient interface comprises a pair of side arms located on opposite sides of a body portion.

In some configurations, the headgear comprises a rear portion.

In some configurations, the front portion is substantially rigid.

In some configurations, the front portion and/or the rear portion are substantially non-stretch.

In some configurations, the chinstrap is a stretch component.

In some configurations, the chinstrap is detachable from another portion ora remainder of the headgear.

In some configurations, the chinstrap comprises a bifurcated portion, a chin cup and/or a chin gripper configured to be located at a chin of a patient.

In some configurations, the first part and the second part of the two-part connection are releasable from one another.

In some configurations, the first part of the two-part connection of the interface securement system comprises a pair of first connection portions, each located on an opposite side of the headgear.

In some configurations, the chinstrap comprises the pair of first connection portions.

In some configurations, the front portion comprises the pair of first connection portions.

In some configurations, the front portion comprises a pair of side tabs located on opposite sides of the front portion, each of the pair of side tabs comprising the first part of the two-part connection to thereby define one of the pair of first connection portions.

In some configurations, the second part of the two-part connection of the interface securement system comprises a pair of second connection portions, each located on an opposite side of the patient interface.

In some configurations, each of the pair of second connection portions are located on a respective one of the pair of side arms of the patient interface.

In some configurations, the two-part connection of the interface securement system can include but is not limited to a hook and loop fastener, a magnetic fastener, a post and aperture connection, a releasable adhesive, or an interlocking buckle or clip.

In some configurations, each of the pair of side tabs defines an angle with an adjacent portion of the headgear.

In some configurations, the angle is between about 110-160 degrees, such as about 140 degrees.

In some configurations, each of the pair of side tabs is configured to be located on the patient's cheek region in use.

In some configurations, the front portion comprises a composite structure of a plastic core and a textile cover, wherein the cover and the core are attached by a permanent bond created by introduction of a molten material onto or into the cover, which is allowed to cool to form the core.

An aspect of the present disclosure involves a patient interface assembly including a patient interface configured to deliver breathing gases to the airway of a patient. The patient interface assembly includes an inspiratory tube configured to deliver the breathing gases to the patient interface. The patient interface assembly includes a headgear configured to support the patient interface. The headgear includes a rear portion having a first degree of stretch and/or a front portion having a second degree of stretch, and a chinstrap having a third degree of stretch. The third degree of stretch is greater than the first degree of stretch and the second degree of stretch.

In some configurations, the first degree of stretch is substantially non-stretch.

In some configurations, the second degree of stretch is substantially non-stretch.

In some configurations, the third degree of stretch is sufficient to allow a patient to open his or her mouth.

In some configurations, the chinstrap is detachable from one or both of the front portion and the rear portion.

In some configurations, the chinstrap attaches to the front portion.

In some configurations, the chinstrap comprises a first part of a releasable connection and the front portion comprises a second part of the releasable connection, wherein the releasable connection can include but is not limited to a hook and loop fastener, a magnetic fastener, a post and aperture connection, a releasable adhesive, or an interlocking buckle or clip.

In some configurations, the chinstrap is attachable to the front portion such that an effective length of the chinstrap is adjustable.

In some configurations, the chinstrap is a stretch component.

In some configurations, the chinstrap and/or the front portion are configured for attachment to the patient interface.

In some configurations, the chinstrap comprises a bifurcated portion, a chin cup and/or a chin gripper configured to be located at a chin of a user.

In some configurations, the front portion is flexible in torsion.

In some configurations, a length of the front portion is adjustable.

In some configurations, the front portion comprises a first strap portion and a second strap portion configured to connect to one another along an overlapping portion, wherein a length of the overlapping portion is variable to permit adjustment of the length of the front portion.

In some configurations, the first strap portion comprises an opening and the second strap portion passes through the opening.

In some configurations, a length of the rear portion is adjustable.

In some configurations, each side of the front portion comprises a buckle, wherein each of a first end and a second end of the rear portion passes through a respective one of the buckles, folds back on itself and attaches to itself.

In some configurations, the rear portion comprises an increased width central portion having a pattern of cutouts.

In some configurations, the pattern of cutouts of the increased width central portion defines a first ellipse and a second ellipse within the first ellipse.

In some configurations, the rear portion comprises a midline strap configured to extend over the top of a head of the patient in a forward-rearward direction and attach to the front portion.

In some configurations, a notch on each side of the midline strap where the midline strap originates from the rear portion.

In some configurations, the patient interface assembly further includes an interface securement system configured to couple the patient interface to the headgear. The interface securement system includes a two-part connection, wherein a first part of the two-part connection is located on the chinstrap or the front portion and a second part of the two-part connection is located on the patient interface.

In some configurations, the patient interface further comprises an expiratory conduit configured to convey expired gases and an unused portion of the breathing gases away from the patient interface.

In some configurations, the expiratory conduit is connected to a resistance device, which can be a water resistance valve.

In some configurations, the patient interface is a sealing interface that contacts and creates a seal with a face of the patient.

In some configurations, the patient interface is a mask or a cannula.

In some configurations, the patient interface comprises a pair of side arms located on opposite sides of a body portion.

In some configurations, the inspiratory tube is attachable to the headgear.

In some configurations, the headgear comprises a loop configured to secure the inspiratory tube relative to the headgear.

In some configurations, the expiratory tube is attachable to the headgear.

In some configurations, the headgear comprises a loop configured to secure the expiratory tube relative to the headgear.

An aspect of the present disclosure involves a headgear for a respiratory interface, which includes a body portion having an attachment region configured to support the respiratory interface. The headgear also includes a chinstrap. The attachment region comprises a first part of a releasable connection that is configured to connect to a second part of the releasable connection on the respiratory interface, wherein the releasable connection can include but is not limited to a hook and loop fastener, a magnetic fastener, a post and aperture connection, a releasable adhesive, or an interlocking buckle or clip.

In some configurations, the body portion comprises a first portion and a second portion, wherein the first portion and the second portion define an angle therebetween and wherein the attachment region is located at least on the second portion.

In some configurations, the angle is between about 110-160 degrees, such as about 140 degrees.

In some configurations, the second portion comprises an attachment tab.

In some configurations, the second portion is configured to be located on the patient's cheek region in use.

In some configurations, the attachment region is located on both of the first portion and the second portion.

In some configurations, the body portion comprises a composite structure of a plastic core and a textile cover, wherein the cover and the core are attached by a permanent bond created by introduction of a molten material onto or into the cover, which is allowed to cool to form the core.

DETAILED DESCRIPTION

Embodiments of systems, components and methods of assembly and manufacture will now be described with reference to the accompanying figures, wherein like numerals refer to like or similar elements throughout. Although several embodiments, examples and illustrations are disclosed below, it will be understood by those of ordinary skill in the art that the inventions described herein extends beyond the specifically disclosed embodiments, examples and illustrations, and can include other uses of the inventions and obvious modifications and equivalents thereof. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner simply because it is being used in conjunction with a detailed description of certain specific embodiments of the inventions. In addition, embodiments of the inventions can comprise several novel features and no single feature is solely responsible for its desirable attributes or is essential to practicing the inventions herein described.

FIG.1illustrates infant positive airway pressure (PAP) (e.g., continuous positive airway pressure (CPAP)) system, generally referred to by the reference numeral10. The system10is capable of providing PAP (e.g., CPAP) therapy to a neonate or an infant patient12for an extended period of time. The PAP therapy is delivered through a suitable patient interface14. The system10is disclosed herein in the context of continuous positive airway pressure (CPAP) therapy; however, the system10could also provide other types or modes of positive airway pressure (PAP) therapy. Accordingly, references to CPAP therapy herein are understood to also include other types of PAP therapies, unless specifically indicated otherwise.

The illustrated system10includes a source of breathing gas20, which can be a flow generator that produces a pressurized flow of atmospheric air. However, other suitable sources of breathing gas can also be used. The breathing gas can be air, oxygen, a blend of air and oxygen, or any other suitable gas for use in respiratory therapy. The source of breathing gas20provides a flow of breathing gas at an initial pressure or within an initial pressure range. The flow rate of the flow of breathing gas can be provided at a suitable level for the desired therapy.

A first gases supply conduit24supplies the flow of breathing gas from the flow generator20to an optional humidifier32. The humidifier32provides humidity or vaporized liquid, such as water, to the flow of breathing gas received from the flow generator20. The humidifier32outputs a flow of humidified breathing gas to the patient interface14through a suitable conduit, such as a second gases supply conduit36. The humidifier32can output a flow of humidified breathing gas at a desired temperature and absolute humidity, such as an optimal temperature of about 37 degrees Celsius and absolute humidity of about 44 mg/L, or within a desirable or acceptable range of the optimal temperature and absolute humidity. The second gases supply conduit36can be a heated supply tube such that a temperature of the flow of breathing gas is maintained at an elevated level within the second gases supply conduit36and to avoid or limit condensation within the second gases supply conduit36or patient interface14.

From the humidifier system32, the flow of breathing gas is supplied to the patient interface14, which can be any suitable type of interface capable of supplying a breathing gas to the respiratory system of the patient. The illustrated interface14is a nasal cannula having nasal prongs that are inserted into the nostrils of the infant patient12. However, other suitable patient interfaces14can also be used, such as a face mask that covers the nose, or a mask that covers both the nose and mouth of the infant patient12.

In some configurations, the system10is a biased flow system in which breathing gas is constantly flowing within the system10generally in a direction from the inlet of the patient interface14to the outlet of the patient interface14. Thus, the infant patient12can inhale a portion of the flow of breathing gas and the remainder is passed through the patient interface14. Exhaled or expiratory gases can mix with the flow of breathing gas and exit the patient interface14along with the unused portion of the flow of breathing gas. For convenience, the gases exiting the patient interface14are referred to as expiratory gases or the flow of breathing gas, although it is understood that either or both of patient exhaled gases and unused breathing gases can be present at any particular point in time.

Expiratory gases flow from the patient interface14to an expiratory pressure device60, which is configured to regulate the minimum pressure within the system10to a level above ambient or atmospheric pressure. The expiratory pressure device60is connected to the patient interface14by a suitable conduit, such as an expiratory conduit62. However, in an alternative arrangement, the expiratory pressure device60can be connected directly to or integrated with the patient interface14.

The expiratory pressure device60is configured to provide a minimum pressure or minimum backpressure within the system10and, in particular, at the patient interface14, which can be referred to as the positive end expiration pressure (PEEP). In the illustrated system10, the expiratory pressure device60is an oscillatory valve capable of providing pressure oscillations relative to a mean PEEP pressure. It is believed that such pressure oscillations are beneficial to the infant patient12and may result in improved gas exchange and reduce the infant patient's12work of breathing. Thus, an oscillatory pressure expiratory pressure device60is particularly preferred. One type of oscillating pressure expiratory pressure device60is a fluid resistance valve, in particular a liquid or water resistance valve, which is often referred to as a bubbler. In general, a water resistance valve delivers the expiratory gases to an outlet that is submerged in a water reservoir resulting in a resistance to the exit of the expiratory gases that is greater than that caused by ambient or atmospheric pressure and related to the depth of the outlet relative to a surface of the water within the water reservoir. In some arrangements, the depth of the outlet is adjustable to allow the PEEP to be adjusted to a desired level. One suitable bubbler is the Bubble CPAP generator sold by the Applicant and Assignee of the present application. Preferably, the bubbler (or other oscillatory pressure device) is capable of producing vibrations in the infant patient's chest at a frequency of between about 5-30 Hz.

An example patient interface14in the form of a nasal cannula is illustrated inFIGS.2-4. The patient interface14can include a central body portion100and a pair of side arm portions102extending in opposite lateral directions from the central body portion100. In the illustrated arrangement, the central body portion100comprises one or more (e.g., a pair of) nasal elements104, such as nasal prongs or nasal pillows. The patient interface14can be a sealing interface that contacts and creates a seal with a face of the patient12. Accordingly, the nasal elements104of the nasal cannula14can be configured to create a seal with the nares of the patient12. Although a nasal cannula14is shown, the patient interface14could also be in the form of a mask. In other words, the central body portion100could include a seal housing (e.g., a housing portion and a seal portion) configured to create a sealed chamber around a portion of the patient's12nose including the nostrils, the patient's12mouth, or both.

FIGS.2-4illustrate one arrangement for securing the patient interface14to the face of the patient12. In the illustrated arrangement, the patient interface14is secured to the face (e.g., the cheeks or cheek regions) of the patient12at or along one or both side arms102. The illustrated securement system110comprises a two-part releasable connection, which includes a pair of patches112,118that are affixed to the patient12and the patient interface14, respectively. In the illustrated arrangement, the securement system110is provided on each of the side arms102of the patient interface14.

The first patch112comprises a dermal patch portion or dermal patch114that is adhered or otherwise attached to the patient's skin. The dermal patch114has a patient side that faces the patient's12skin and an interface side that faces the patient interface14. The patient side of the dermal patch114may be attached to the skin of a patient by a dermatologically sensitive adhesive, such as a hydrocolloid. The patient interface side of the dermal patch114can be provided with the first part116of the two-part releasable connection of the securement system110. The dermal patch114and the first part116of the securement system110can be integrated into a single component (the first patch112) during the manufacturing process.

The second patch118is a patient interface patch. The second patch118also has a patient side and an interface side. The patient side of the second patch118is disposed adjacent the first patch112when the securement system110is engaged. The second patch118is or comprises the complimentary second part of the two-part releasable connection of the securement system110so that the respective parts of the two-part releasable connection are easily engaged with one another when the patches112,118are brought together. The interface side of the second patch118is affixed to the patient interface14. The second patch may be integrated with or suitably adhered to the patient interface14, such as one or both side arms102.

The two-part releasable connection may comprise a hook and loop fastener, a magnet or an array of magnets disposed on the respective patches with the poles suitably arranged, an adhesive arrangement that is activated when the patches are urged together, a post and aperture connection, an interlocking buckle or clip, or another suitable releasable coupling. In the illustrated arrangement, the two-part releasable connection comprises a hook and loop fastener. The first patch112may include one of a hook or a loop material and the second patch118may include the other of the hook or loop material, such that the patches112,118are releasably attachable or connectable to each other.

Under some circumstances, it may be infeasible or undesirable to secure the patient interface14using the securement system110or another type of securement system that utilizes adhesion of one or more components to the patient' skin. For example, some patients may be too small for the first patch112to be properly accommodated on the cheeks or cheek regions. Or, the first patch112may not adhere to the patient's face for the full duration of the therapy. Under these circumstances, a headgear, such as the headgear200illustrated inFIGS.5-10or the headgear300illustrated inFIGS.11-16, may be used as an alternative or supplemental support for the patient interface14. The headgear200,300could also be used with other patient interfaces, or could be modified for use with other interfaces.

As illustrated inFIG.5, the patient interface14and the headgear200together form at least a portion of a patient interface assembly. The patient interface14includes an inspiratory conduit202configured to deliver the breathing gases to the nasal elements104of the patient interface14. The inspiratory conduit202can be a portion of, or can be connected to, the second gases supply conduit36(FIG.1). In the illustrated arrangement, the patient interface14includes an expiratory conduit204configured to convey expired gases and an unused portion of the breathing gases away from the central body portion100of the patient interface14. The expiratory conduit204can be a portion of, or can be connected to, the expiratory conduit62. As described above, in some configurations, the expiratory conduit62is connected to a resistance device, which can be the water resistance valve60.

The patient interface14is supported in whole or in part by the headgear200. In the illustrated arrangement, the headgear200includes a front portion210, a rear portion212, and a chinstrap214. The patient interface14can be supported by and/or directly coupled to any portion or portions of the headgear200, including without limitation any one or more of the front portion210, the rear portion212and the chinstrap214. The front portion210, the rear portion212and the chinstrap214cooperate to form a support structure that is stable on the patient's12head so that the patient interface14can be held in a stable position by the headgear200. In the headgear200ofFIGS.5-10, the front portion210and the rear portion212are separate structures that are coupled to one another in use. However, in other arrangements, at least portions of the front portion and the rear portion can be formed as a single structure. For example, as described further below, the headgear300ofFIGS.11-16comprises a pair of side members that are coupled to one another in use, with each side member having a front portion and a rear portion.

With particular reference toFIGS.6and7, the front portion210comprises a strap220that is configured in use to extend over the patient's12head from one side to the other. In some configurations, the ends of the strap220are configured to be located at a level above the ears, such as at or near the temples of the patient12. In some configurations, the strap220is configured to be located forward of a crown of the patient's12head. For example, the strap220can be configured to be located over a region corresponding to the rearward portion of the frontal bone or over a region corresponding to the junction between the frontal bone and the parietal bone of the patient12.

The strap220can be adjustable in length. For example, the front portion210can include two portions222,224that are connectable along a variable-length overlapping portion226. By adjusting a length of the overlapping portion226, an overall length of the front portion210, or of a strap220of the front portion210, can be adjusted to suit an individual patient12. The overlapping portion226can be configured such that one strap portion222lies over top of and is releasably connectable to the other strap portion224. For example, one strap portion222,224can include a first part of a two-part connection and the other strap portion222,224can include a second part of the two-part connection. The two-part connection can be the same as or similar to the two-part connection described above with respect to the securement system110or can be of another suitable arrangement.

In one possible configuration, as shown inFIG.10, one of the strap portions222,224can include an opening228within the strap portion222,224and the other of the strap portions222,224can pass through the opening to create the overlapping portion226. In such an arrangement, an end222a,224aof each strap portion222,224is located on top of the other strap portion222,224. The end222a,224aof each strap portion222,224can be releasably connectable to the other strap portion222,224. For example, the end222a,224aof each strap portion222,224can include a first part of a two-part connection and a portion of each strap portion222,224spaced inwardly from a respective one of the ends222a,224acan include a second part of the two-part connection. The two-part connection can be the same as or similar to the two-part connection described above with respect to the securement system110or can be of another suitable arrangement. Alternatively, the strap220can be adjustable in a manner that does not create an overlap between the strap portions222,224. For example, each of the strap portions222,224can pass through a buckle and be folded over onto, and attached to, themselves, as shown and described further below with reference to the headgear300ofFIGS.11-16.

In some configurations, the front portion210, or at least the strap220of the front portion210, is flexible in torsion. That is, the front portion210, or at least the strap220, is flexible in a rotation direction around a longitudinal axis or a lengthwise direction of the front portion210or the strap220. Such an arrangement can permit the front portion210to adapt to different head shapes. In some configurations, the front portion210, or at least the strap220, is non-stretchable, or substantially non-stretchable, at least in response to normal or expected forces during use. In some configurations, the front portion210comprises a plastic material to provide some or all of the non-stretch characteristics. The plastic material (or other material(s) of the front portion210) can be combined with other materials, such as by a co-molding or an over-molding process, for example. In some configurations, the front portion210comprises a composite structure of a plastic core and a textile cover, wherein the cover and the core are attached by a permanent bond created by introduction of a molten material onto or into the cover, which is allowed to cool to form the core. Such an arrangement provides the benefits of plastic, with the soft appearance and touch of a textile strap. In some configurations, the front portion210comprises a thermoplastic elastomer (TPE) material. Other suitable materials may include any soft, flexible material, such as but not limited to a thermoplastic polyurethane (TPU), silicone or a non-stretch (or substantially non-stretch) fabric.

As described above, the patient interface14can be supported by and/or directly coupled to any portion or portions of the headgear200, including without limitation any one or more of the front portion210, the rear portion212and the chinstrap214. In the illustrated arrangement, the patient interface14is supported at least by the front portion210. The front portion210includes at least one attachment region. The illustrated front portion210includes an attachment region230on each side of the front portion210. The illustrated attachment regions230are located at or near the respective ends of the strap220, but could be located at any location along the strap220, other region of the front portion210and/or other portion of the headgear200. The attachment regions230are configured to support the patient interface14in a manner to maintain the patient interface14in a proper location on the patient12, which may involve maintaining an adequate seal between the patient interface14and the patient12in use at least under normal circumstances. Accordingly, it can be desirable for the headgear200to maintain the attachment regions230in a stable position on the face of the patient12to provide a stable attachment location for the patient interface14.

In the illustrated arrangement, the attachment region230is or comprises an attachment tab232. The attachment tabs232are configured to support the patient interface14. Each of the pair of attachment tabs232extends in a forward direction and is configured to lie generally across the cheek region of the patient12, as illustrated inFIG.7. The attachment tabs232are configured to be located generally in the same or a similar location as at least a portion of the first patch112, as shown inFIGS.2and3. The attachment tabs232may each be provided with a portion of a two-part connection that is complementary to the patch118of the patient interface14, as shown inFIGS.2-4. The portion of the two-part connection can cover a substantial entirety of the tab232and, in some configurations, may extend beyond the tab232onto a portion of the strap220. That is, the attachment tabs232may function in a manner similar to the first patch112. The portion of the two-part connection, which can for example be a hook portion of a hook and loop fastener, can be permanently attached to the attachment tab232of the front portion210, such as by an over-molding operation. The shape and features of the attachment regions230and attachment tabs232can be the same as or similar to the attachment regions230and attachment tabs232of the headgear300, as shown in and described with reference toFIG.16.

Additional structures can also be provided that assist in maintaining the patient interface14in a suitable and/or stable location and/or orientation on the face of the patient12. For example, the patient interface14can be provided with an optional third arm (in addition to the pair of side arms102), which can be implemented as a forehead support238(FIG.5). The optional forehead support238can be coupled to the patient interface14and can extend upwardly therefrom towards, to or beyond the forehead of the patient14. An upper end of the optional forehead support238can be secured to the forehead of the patient14, such as with a dermal patch as described herein, and/or can be secured to the headgear200. For example, the optional forehead support238can be coupled (e.g., releasably coupled) to the front portion210and/or rear portion212of the headgear200. The optional forehead support238can be coupled to the headgear200by any suitable arrangement, such as a two-part connection (e.g., hook and loop fastener), buckle, quick-release connector, or others.

In the illustrated arrangement, the front portion210includes a connection region240on each side at or near the respective ends of the strap220configured for connection with the rear portion212. The illustrated connection region240comprises a buckle or loop242configured to receive a strap of the rear portion212to form at least a portion of a connection between the front portion210and the rear portion212of the headgear200. In the illustrated arrangement, each of the connection regions240and/or loops242is located at or near a junction between the strap220and a respective one of the attachment regions230or tabs232. The loop242extends from a rearward edge of the strap220in the illustrated arrangement to avoid overlap of the rear portion212and the front portion210. However, the loop242could instead be located on or in front of the strap220, if desired. Furthermore, other suitable types of connections can be used, such as two-part connections, interlocking buckles, post-and-aperture connections, or others.

The chinstrap214extends from one side to the other side of the headgear200and is configured to be positioned over the chin of the patient12. Each end of the chinstrap214is configured to be connected to another portion of the headgear200, such as one or both of the front portion210and the rear portion212. In the illustrated arrangement, each end of the chinstrap214is connected to the front portion210of the headgear200. The chinstrap214can be located on or near the ends of the strap220. The chinstrap214can also overlie a portion of the attachment regions230or attachment tabs232. The chinstrap214may be connected to the front portion210at the attachment region230, such as by a two-part connection (e.g., hook and loop fastener). In addition, or in the alternative, the chinstrap214can be connected to the headgear200at one or both ends by a different type of connection, such as a loop or a quick-release buckle or clip to mitigate the risk of failure of the connection. In some configurations, the chinstrap214does not overlie the loops242and can be positioned forward of the loops242to facilitate adjustment of the rear portion212. The chinstrap214can be configured to directly support the patient interface14, either alone or in combination with the front portion210, rear portion212and/or another portion of the headgear200.

In some configurations, the chinstrap214is detachable from, or releasably connectable to, one or both of the front portion210and the rear portion212. For example, each end of the chinstrap214can overlap or lie across one or both of the front portion210and the rear portion212and can be connected thereto with a suitable fastener. In some configurations, the ends of the chinstrap214can include a first part of a two-part connection and the front portion210and/or the rear portion212can include a second part of a two-part connection. The two-part connection can be the same as or similar to the two-part connection described above with respect to the securement system110or can be of another suitable arrangement. In some configurations, the front portion210and/or the rear portion212includes the hook portion of a hook and loop fastener so that the hook portion faces away from the patient's12face.

In some configurations, the chinstrap214is attachable to the front portion210and/or the rear portion212such that an effective length of the chinstrap214(e.g., a portion not overlapping with the front portion210and/or the rear portion212) is adjustable. For example, the portion of the two-part connection can be located along a sufficient length of the chinstrap214such that the end portion of the chinstrap214can be connected to the front portion210and/or the rear portion212in a variety of different positions to adjust the effective length of the chinstrap214.

In some configurations, the chinstrap214comprises a bifurcated portion250configured to be located at or along a chin of the patient12. For example, the chinstrap214can include a first strap portion252, or a forward strap portion, and a second strap portion254, or a rearward strap portion. The first strap portion252and the second strap portion254cooperate to define an opening256therebetween. The opening256is configured to receive a portion of the patient's12chin, with the first strap portion252being located on a forward portion of the chin and the second strap portion254being located on a rearward portion of the chin. Such an arrangement facilitates proper location and retention of the chinstrap214on the patient12.

The rear portion212of the headgear200is configured to engage a rear portion of the patient's12head and to retain the front portion210of the headgear200and the patient interface14in a proper position on the patient12. The illustrated rear portion212includes a pair of side strap portions260located on an opposite sides of the headgear200. The side strap portions260extend from a central section262of the rear portion212. The central section262is configured to be located on a rear portion of the patient's12head in general opposition to the patient interface12. In some configurations, the central section262can overlie a region corresponding to a rear portion of the parietal bone and/or the occipital bone. Each side strap portion260is configured to connect to a respective one of the loops242. As illustrated inFIG.6, for example, each side strap portion260is configured to be located above a level of the ear of the patient12.

In some configurations, an effective length of the rear portion212is adjustable. In some configurations, the first and second side strap portions260define a respective one of a first end and a second end of the rear portion260. Each end or strap portion260passes through a respective one of the buckles or loops242, folds back on and attaches to itself. For example, an end of each of the strap portions260includes a first part of a two-part connection and an intermediate portion of each of the strap portions260includes a second part of the two-part connection. The two-part connection can be the same as or similar to the two-part connection described above with respect to the securement system110or can be of another suitable arrangement. For example, the two-part connection can be a hook and loop fastener. In some configurations, the end of each of the strap portions260comprises the hook portion of the hook and loop fastener and the intermediate portion of each of the strap portions260comprises the loop portion of the hook and loop fastener. In some configurations, at least the strap portions260can be constructed with an outer layer that is the loop portion of a hook and loop fastener.

In some configurations, the rear portion212comprises an optional midline strap264configured to extend over the top of the head of patient12in a forward-rearward or anterior-posterior direction. In the illustrated arrangement, the optional midline strap264is integrally formed with another portion or a remainder of the rear portion212. However, in other arrangements the optional midline strap264could be releasably connectable to the remainder of the rear portion212so that it can be removed if desired, or can be omitted altogether. In those configurations in which it is used, the midline strap264can limit or prevent the headgear200from slipping down on the patient's12head. In the illustrated arrangement, the midline strap264originates at the central section262of the rear portion212and connects (e.g., releasably connects) to the front portion210.

In some configurations, a length of the midline strap264is adjustable. For example, a forward end of the midline strap264can loop around the front portion210and connect to the front portion210and/or to itself. In some configurations, the end of the midline strap264can comprise a first part of a two-part connection and the front portion210and/or an intermediate portion of the midline strap264can comprise a second part of the two-part connection. The two-part connection can be the same as or similar to the two-part connection described above with respect to the securement system110or can be of another suitable arrangement. For example, the two-part connection can be a hook and loop fastener. In some configurations, at least an outwardly facing surface comprises the hook portion of the hook and loop fastener and the midline strap264comprises the loop portion of the hook and loop fastener. In some configurations, midline strap264can be constructed with an outer layer that is the loop portion of a hook and loop fastener.

In some configurations, the central section262comprises or defines an increased width portion of the rear portion212. The increased width of the central section262can increase comfort for the patient12by spreading the retention force over a larger area to reduce the pressure on the patient's12head. The central section262can include one or more openings or cutouts270. The cutouts270can increase the flexibility of the central section262to conform to the patient's12particular head shape and/or increase comfort by reducing the area for heat build-up underneath the central section262.

In the illustrated arrangement, the central section262includes a plurality of cutouts270. The cutouts270are arranged in a pattern that provides symmetry to the central section262along one or more axes or directions (e.g., a lengthwise direction and/or a widthwise direction). In the illustrated arrangement, the pattern of cutouts270in combination with an outer shape of the central section262defines at least one ellipse, such as a first ellipse272and a second ellipse274, within the central section262. The first ellipse272is larger and surrounds the second ellipse274. Connecting strap portions276extend between the first ellipse272and the second ellipse274in a lengthwise direction of the central section262. Such an arrangement provides an advantageous balance between conformability and support.

In some configurations, the rear portion212of the headgear200further comprises a notch280on each side of a junction between the midline strap264and the central section262. The notches280cooperate to define a reduced width end portion of the midline strap264wherein the midline strap264intersects the central section262. Such an arrangement provides some amount of decoupling between the midline strap262and the central section262and facilitates the ability of the midline strap262to conform to the curvature of the top of the head of the patient12without affecting or being affected by deformation of the central section262as it conforms to the curvature of the rear of the head of the patient12.

The headgear200can include one or more tube management features configured to restrain breathing tubes of the system10, such as the inspiratory conduit202and/or the expiratory conduit204. In some configurations, the headgear200includes or is configured to define a tube management feature embodied as a loop290that secures the inspiratory conduit202in place relative to the headgear200. In the illustrated arrangement, the loop290is defined by an end portion of the side strap260that passes through the loop242and is attached to itself. The end portion can also pass over the inspiratory conduit202after passing through the loop242and before attaching to itself to create a loop290that surrounds the inspiratory conduit202. In the illustrated configuration, the headgear200includes or is configured to define a tube management feature embodied as a loop292that secures the expiratory conduit204in place relative to the headgear200. The loop292can be formed in a manner similar to the loop290, but from the other side strap260. In other configurations, the loops290,292can be formed separately from the side straps260, such as by dedicated strips of material. Other suitable retention mechanisms can also be used. For example, the conduits202,204can include one part of a two-part connection and the headgear200(e.g., the rear portion212) can include the other part of the two-part connection so that the conduit202,204can be secured to the headgear200. The two-part connection can be the same as or similar to the two-part connection described above with respect to the securement system110(e.g., a hook and loop fastener) or can be of another suitable arrangement.

In some configurations, different parts or portions of the headgear200have different stretch properties. For example, any one of the front portion210, rear portion212and chinstrap214can have different stretch properties relative to any other of the front portion210, rear portion212and chinstrap214. As used herein, stretch refers to elongation (e.g., percent elongation) of the headgear200in response to an applied load. Such elongation may relate to the elasticity of the material or materials form which the headgear200or portion thereof is constructed. Stretch may occur in one or more directions. Often, the relevant stretch is in a direction generally along a length or an effective length of the headgear200or portion thereof. For example, the relevant stretch can be along a lengthwise direction of the strap220of the front portion210, the side straps260or midline strap264of the rear portion212, or the end portions of the chinstrap214. However, the relevant stretch can refer to a direction generally along a width or an effective width of the headgear200or portion thereof, or both the length and width directions.

Stretch may not be uniform over an entire length (or width) of the portion (e.g., front portion210, rear portion212or chinstrap214). Thus, a comparison of the stretch of different components or portions can compare a change in overall length, or effective overall length, of the components or portions. For example, a degree of stretch of the front portion210can relate to the elongation (e.g., percent elongation) of the strap220in response to a given load. For example, a degree of stretch of the rear portion212can relate to the elongation (e.g., percent elongation) of the rear portion212between the end of one of the side straps260to the end of the other of the side straps260in response to a given load. For example, a degree of stretch of the chinstrap214can relate to the elongation (e.g., percent elongation) of the strap220in response to a given load. For the purpose of comparison between the different components or portions of the headgear200, the load applied should be consistent between the components or portions.

In some configurations, the chinstrap214is a stretch component, which possesses some amount of stretch so that the chinstrap214can be tensioned when applied and/or can maintain tension in use. A tensioned chinstrap214can enhance the ability of the chinstrap214to maintain the headgear200properly positioned on the head of the patient12. The degree of stretch of the chinstrap214may be selected to permit the patient12(e.g., an infant patient) to open his or her mouth while the chinstrap214is in use. The chinstrap214can be configured to encourage the patient12to normally keep his or her mouth closed, but can permit deliberate opening of the mouth. The degree of stretch of the chinstrap214may be selected to permit stretching of the chinstrap214to accommodate other facial movements of the patient12, including but not limited to those that occur during side sleeping, while allowing a portion or a remainder of the headgear200to maintain a relatively stable position on the head of the patient12to maintain a sufficient seal and/or position of the patient interface14.

In some configurations, the chinstrap214has a greater degree of stretch than one or both of the front portion210and the rear portion212. In some configurations, the chinstrap214has a degree of stretch, or a percentage elongation, that is significantly greater than the degree of stretch of the front portion210and/or the rear portion212and/or a remainder of the headgear200. Such arrangements allow the chinstrap214to stretch if the patient12opens his or her mouth, while the remainder of the headgear200tends to stay in place. In other words, the greater degree of stretch of the chinstrap214allows the chinstrap214to preferentially stretch in response to the patient12opening his or her mouth, so that such movement is primarily or completely accommodated by the chinstrap214. Under such circumstances, the stretch, if any, of the front portion210and/or the rear portion212can be less than or significantly less than the stretch of the chinstrap214.

In some configurations, the degree of stretch of the front portion210is substantially non-stretch. In some configurations, the degree of stretch of the rear portion212is substantially non-stretch. As used herein, substantially non-stretch means that the component or portion does not stretch under normal or expected loads experienced during use, or does not stretch to an extent that negatively impacts the ability of the headgear200to maintain a proper or effective position of the patient interface14on the face of the patient12.

FIGS.11-16illustrate another example headgear300configured to support the patient interface14, which is embodied as a nasal mask. The patient interface14is supported in whole or in part by the headgear300. The headgear300provides a support structure that is stable on the patient's12head so that the patient interface14can be held in as table position by the headgear300. The headgear300can be similar in some respects to the headgear200ofFIGS.5-10, and is described in the context of differences relative to the headgear200. Features of the headgear300not described in detail can be the same as or similar to corresponding features of the headgear200, or can be of another suitable arrangement. In addition, features of each headgear200,300can be implemented on the other headgear200,300. For example, the chin strap214of the headgear300, or specific features thereof, can be used with the headgear200and vice-versa.

The illustrated headgear300ofFIGS.11-16includes a pair of side members302,304that are coupled to another to form a portion or an entirety of the headgear300. In some configurations, the side members302are adjustably coupled to one another. The provision of two side members302,304that are adjustably coupled allows for adjustment of a size (e.g., a perimeter length or circumference) of the headgear300in a manner similar to the separate front portion210and rear portion212of the headgear200ofFIGS.5-10. However, in other arrangements, the side members302,302can be non-adjustable, permanently coupled and/or integrally formed.

In the illustrated arrangement, the side members302,304of the headgear300each comprise a front portion306and a rear portion308, which can correspond from a functional standpoint, with respect to one or more functions, with the front portion210and the rear portion212, respectively, of the headgear200. Thus, references herein to the front portion and the rear portion of a headgear can equally apply to portions formed separately or portions formed as a single piece, including but not limited to the specific example portions210,212,306and308.

In the illustrated arrangement, the side members302,304are coupled to one another to form a portion or an entirety of the headgear300. The illustrated side members302,304are coupled to one another substantially along a midline of the head of the patient12. However, in other arrangements, the side members302,304can be coupled to one another at different locations (e.g., offset from a midline of the head of the patient12) or can include an additional member (e.g., a central member) intermediate the side members302,304.

In the illustrated arrangement, the side members302,304are mirror images of one another or are substantially mirror images from one another. In other words, the side members302,304can be mirror images in basic shape; however, one of the side members302,304can include additional structure or features not shared by the other of the side members302,304. For example, the side members302,304can include different parts of a two-part connector.FIG.16illustrates the side member304configured to be positioned on the left side of the patient12in a planar or laid-flat orientation. In the illustrated arrangement, the side member302configured to be positioned on the right side of the patient12can be a mirror image of the side member304. Accordingly, structures, features or other aspects of the side member302can be assumed to be the same as or similar to the corresponding structures, features or other aspects described with respect to the side member304, except mirrored relative thereto.

The illustrated headgear300includes the side members302,304releasably connected to one another. In some configurations, the side members302,304can be adjustably coupled to one another such that a relative position of the side members302,304can be varied to suit a variety of patients12. Adjustment of the relative position of the side members302,304can permit adjustment of a location of the attachment region230relative to the face of a particular patient12so that the patient interface14can be properly positioned. As described above, the location of the attachment region230can be generally overlying the cheek or cheek region of the patient12, such as in the location illustrated and described with respect toFIGS.2-4. Additional details of an example attachment region230are described further below with reference toFIG.16.

In some configurations, each of the side members302,304includes at least one strap. In some configurations, each of the side members302,304includes multiple straps. In some configurations, each of the side members302,304includes a top strap310. In some configurations, each of the side members302,304includes a rear strap312. In the illustrated arrangement, each of the side members302,304includes the top strap310and the rear strap312. The top strap310and the rear strap312of one of the side members302,304is connected to a respective one of the top strap310and the rear strap312of the other of the side members302,304such that the top straps310cooperate to form a top strap310of the headgear300and the rear straps312cooperate to form a rear strap312of the headgear300. In the illustrated arrangement, the top strap310is a crown strap or coronal strap, which is located further rearward on the head of the patient12than the strap220of the headgear200. The top strap310can overlie a region corresponding to a top or forward portion of the parietal bone of the patient12. The rear strap312can be positioned similarly to the central section262of the headgear200. The rear strap312can overlie a region corresponding to the rear portion of the parietal bone and/or the occipital bone. However, other positioning of the straps310,312can also be used, such as positions the same as, or similar to, those of the strap220and the central section262of the headgear200.

The top strap310and the rear strap312of one of the side members302,304is connected to a respective one of the top strap310and the rear strap312of the other of the side members302,304by a buckle314. The buckle314includes two openings through which a strap310,312of a respective side member302,304passes. The straps310,312then fold over onto themselves and are secured to themselves with a suitable fastener, such as a two-part connection (e.g., a hook and loop fastener). However, other suitable connections between the straps310,312of the side members302,304can also be used. For example, the straps310,312can be secured to (e.g., adjustably secured to) a respective portion of a quick-release clip or buckle and the portions of the clip or buckle can connect to or disconnect from one another.

In some configurations, the headgear300includes a chinstrap320. The chinstrap320can be similar to the chinstrap214and can function to assist in maintaining the side members302,304and/or other portion of the headgear300in a stable position on the head of the patient12. For example, the chinstrap320can permit the patient12(e.g., an infant patient) to open his or her mouth or to accommodate other facial movements of the patient12while allowing a portion or a remainder of the headgear300to maintain a relatively stable position on the head of the patient12to maintain a sufficient seal and/or position of the patient interface14. The chinstrap320can be configured to encourage the patient12to normally keep his or her mouth closed, but can permit deliberate opening of the mouth.

In the illustrated arrangement, one or both ends of the chinstrap320includes a grip portion or a grip tab330. The grip tab330can be configured to facilitate gripping by a caregiver or the patient12to allow for ease of adjustment of the position of the end of the chinstrap320on the side member302,304(or other portion of the headgear300) and/or allow the chinstrap320to be tensioned to a desirable degree. In some configurations, the grip tab330can be a feature that is over-molded onto the underlying material of the chinstrap320. However, in other configurations, the grip tab330can be formed separately from and attached to the chinstrap320by a suitable connection, such as mechanical fasteners or an adhesive connection.

The chinstrap320can include a chin retention feature340, which can be an alternative to the bifurcated portion250of the chinstrap214. In the illustrated arrangement, the chin retention feature340of the chinstrap320comprise a retention element342, which can be a gripper and/or a chin receptacle or chin cup. In some configurations, the retention element342is in the form of a chin cup, which defines a concave surface that receives a portion of the chin of the patient12. In some configurations, the retention element342is constructed from or comprises a material that has good grip characteristics (e.g., a high coefficient of friction) with human skin. In some configurations, the retention element342both receives a portion of the chin of the patient12and includes a material having good grip characteristics. In some configurations, the retention element342is over-molded onto the underlying material of the chinstrap320. However, in other configurations, the retention element342can be formed separately from and attached to the chinstrap320by a suitable connection, such as mechanical fasteners or an adhesive connection. In some configurations, a suitable material is TPE, TPU, silicone or another similar material.

The retention element342can be wider than a width of the underlying strap portion of the chinstrap320and/or a portion of the chinstrap320immediately adjacent the retention element342. In the illustrated configuration, the retention element342includes a central opening that exposes the underlying strap portion of the chinstrap320. The surface facing the patient12can be fully covered by the retention element342or could similarly have an opening that exposes the underlying strap portion of the chinstrap320. In some configurations, a retention element342could be provided to one or both of the first strap portion252and the second strap portion254of the bifurcated portion250of the chinstrap214.

In some configurations, the headgear300can include one or more tube management features configured to restrain breathing tubes of the system10, such as the inspiratory conduit202and/or the expiratory conduit204. For example, the headgear300can include tube management features such as those described above with respect to the headgear200. In the illustrated arrangement, the headgear300includes a tab350that can be secured to the headgear300at each end to define a loop, along with a portion of the headgear300(e.g., one of the side members302,304), through which the tube (e.g.,202or204) can pass. In some configurations, one end (e.g., a rearward end) of the tab350is permanently secured to the portion of the headgear300and the other end (e.g., a forward end) of the tab350makes are leasable connection with the portion of the headgear300by a suitable releasable fastener, such as a two-part connection (e.g., hook and loop fastener). In other arrangements, the tab350can be secured to the portion of the headgear300at an intermediate location and the ends of the tab350can be secured together to form a loop. Other suitable tube management arrangements can also be used, such as providing one part of a two-part connection on the tube (e.g.,202or204) and the other part of the two-part connection on the portion of the headgear300. The two-part connection can be the same as or similar to the two-part connection described above with respect to the securement system110(e.g., a hook and loop fastener) or can be of another suitable arrangement.

With reference toFIG.11, the patient interface14can optionally include a third arm (in addition to the pair of side arms102), which can be implemented as a forehead support238in a manner to that described in connection withFIG.5. The optional forehead support238can be coupled to the patient interface14and can extend upwardly therefrom towards, to or beyond the forehead of the patient14. An upper end of the optional forehead support238can be secured to the forehead of the patient14, such as with a dermal patch, such as those described herein, and/or can be secured to the headgear300. For example, the optional forehead support238can be coupled (e.g., releasably coupled) to the top strap(s)310of the headgear300. The optional forehead support238can be connected to the headgear300directly or indirectly, such as through a member than depends from the top strap(s)310or other portion of the headgear300. The optional forehead support238can be coupled to the headgear300by any suitable arrangement, such as a two-part connection (e.g., hook and loop fastener), buckle, quick-release connector, or others.

With reference toFIG.16, the side member304is shown. As described above, the side member302can be a mirror image, or a substantial mirror image, of the side member304. Accordingly, the description of the side member304herein can equally apply to the side member302(but in a mirrored fashion) unless otherwise indicated or made clear by the context of the disclosure.

As illustrated, in some configurations, one or both of the top strap310and the rear strap312can be curved along its length. A slight radius to one or both of the straps310,312can help the straps310,312conform to the head of the patient12as applied in use. The rear strap312can curve downwardly from a forward end to a rearward (free) end. The top strap310can curve forwardly from a lower end to an upper (free) end.

As illustrated inFIG.16, the side member304includes a gusset region360between the top strap310and the rear strap312. The gusset region360maintains or helps maintain a desirable relative position (e.g., angle) between the top strap310and the rear strap312. That is, the gusset region360can inhibit the straps310,312from moving too close together or from moving too far apart. Such an arrangement can assist in keeping the headgear300(and, thus, the attachment regions230) in a stable location on the head of the patient12. The gusset region360is formed by additional material provided between the straps310,312(or projections of the straps310,312) at a junction between the straps310,312. The material of the gusset region360is unitary with the straps310,312and/or a remainder of the side member304, but could be formed from a separate member or component that is attached to the side member304. For example, a separate gusset360constructed in whole or in part from a material having greater stiffness than the material of the side member304could be attached to the side member304at the junction of the top strap310and the rear strap312.

In some configurations, the headgear300could include an optional midline strap (e.g., similar to the midline strap264) that extends between the top strap310and the rear strap312in the place of or in addition to the gusset region360. In the illustrated arrangement, the rear strap312has a substantially constant width past the gusset region360. However, in some configurations, the rear strap312could increase in width toward the free end or the rear portion of the headgear300as assembled and used. Such an increase in width could be similar to the central section262of the headgear200. In such an arrangement, the several strap portions of the central section of each side member302,304could each be connected to one another by a buckle (e.g., buckle314). Alternatively, a central section could be provided as a single structure that located intermediate the side members302,304.

In the illustrated arrangement, the headgear300or the side member304in particular includes a front strap portion or front strap370that extends in a forward and/or downward direction from the junction between the top strap310and the rear strap312in use. The headgear300or the side member304in particular includes an attachment region230, which may be or include an attachment section. In the illustrated arrangement, the attachment section is embodied by an attachment tab232, which can be the same or substantially the same as the attachment tab232described above with respect to the headgear200. The attachment tab232can extend at an angle380relative to the front strap370or an adjacent portion of the headgear300such that the attachment tab232and the front strap370or adjacent portion do not form a straight line. The angle380can be selected to position the attachment tab232in a desirable orientation relative to the patient12, which can be the same or a similar orientation as the first patches112and/or the side arms102of the patient interface14in use, such as the orientation shown inFIGS.2,3,5-7and11-13, for example.

In some configurations, the attachment tab232is oriented in use to extend forward enough onto the cheek or cheek region of the patient12to properly support the patient interface14and to also avoid the eye of the patient12. In some configurations, the attachment tab232is angled in a downward direction in rearward-to-forward direction such that a rearward end of the attachment tab232is higher than a forward end. Stated another way, the forward end of the attachment tab232can be lower on the face of the patient12than the rearward end. In some configurations, the attachment tab232is configured to at least somewhat conform to the face (e.g., cheek or cheek region). In some configurations, the attachment tab232can extend inwardly toward a midline of the patient12in use. In other words, the attachment tabs232of the headgear300can converge in a rearward-to-forward direction. In some configurations, the attachment tabs232can be curved along one or more axes to have a non-planar shape (e.g., concave facing the patient12), which may better conform to the face of the patient12. In some configurations, it is desirable for the attachment tabs232to avoid a jaw region and/or a nose region of the patient12in use.

In some configurations, the angle380can be between about 110-160 degrees. Such a range of angles can allow the attachment tab232to be properly positioned relative to a front strap370or adjacent portion of the headgear300that passes above and/or in front of the ear of the patient12. For example, as illustrated, the strap220of the headgear200is oriented generally in a vertical direction with the patient's12head upright. With such an arrangement, the angle380may be on a lower end of the range, or may be lower than 110 degrees in some circumstances. As illustrated, the front strap370is oriented to extend downwardly in front of the ear of the patient12with a rearward end of the front strap370higher and rearward of a forward end of the strap370. With such an arrangement, the angle380may be closer to the middle or the higher end of the range, or could be higher than 160 degrees in some circumstances. Furthermore, the illustrated headgear300is useful for an infant or child interface. The angle380and/or other proportions of the headgear300(or headgear200) could vary in an adult version.

As described above, the attachment region230is configured for attachment of the patient interface14. The attachment region230can be located wholly on the attachment tab232. In other configurations, the attachment region can be wholly located on the front strap370. However, in the illustrated arrangement, the attachment region230is located partially on the attachment tab232and partially on the front strap370or a portion of the headgear300adjacent the attachment tab232. For example, the attachment region230can include a fastener or connector390, which is configured to connect directly or indirectly to the patient interface14. The illustrated connector390extends along both the attachment tab232and the front strap370or portion of the headgear300adjacent the attachment tab232.

In some configurations, the connector390is one part of a two-part connection that is complementary to the patch118of the patient interface14, as shown inFIGS.2-4. That is, the connector390may function in a manner similar to the first patch112. The portion of the two-part connection, which can for example be a hook portion of a hook and loop fastener, can be permanently attached to the attachment tab232of the front portion210, such as by an over-molding operation. However, other suitable methods of attachment can also be used, such as a sewn connection, for example. In addition, as described herein, other types of two-part connections can also be used.

The headgear300can be constructed of any suitable material or combination of materials. In some configurations, the side members302,304have a degree of stretch that is less than the degree of stretch of the chinstrap320, similar to the headgear200. In some configurations, the chinstrap320is a stretch component. The chinstrap320can have a degree of stretch that is equal to or greater than any other portion of the headgear300or at least any major structural portion of the headgear300. The side members302,304or other portions of the headgear300beside the chinstrap320can be substantially non-stretch. As described above in connection with the headgear200, it can be desirable to maintain the attachment regions230in a stable location on the face of the patient12so the patient interface14can be maintained in a stable location. For sealing interfaces, such an arrangement can maintain a seal between the interface14and the patient12. For non-sealing interfaces, such an arrangement can maintain the interface14in a proper position, such as maintaining non-sealing cannula prongs within the nares of the patient12. In some configurations, the side members302,304are constructed in whole or in part from a fabric material. In some configurations, the material can be a foam and fabric composite, such as the foam and fabric composite sold under the trade name BREATH-O-PRENE. The chinstrap320can be constructed from an elastic material, such as a fabric material that is or contains elastic materials.

CONCLUSION

It should be emphasized that many variations and modifications may be made to the herein-described embodiments, the elements of which are to be understood as being among other acceptable examples. For example, although the present headgear includes a chinstrap, the headgear could be used without the chinstrap or could be modified for use without the chinstrap. This and all other such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims. Moreover, any of the steps described herein can be performed simultaneously or in an order different from the steps as ordered herein. Moreover, as should be apparent, the features and attributes of the specific embodiments disclosed herein may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

Numerical data may be expressed or presented herein in a range format. Itis to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also interpreted to include all of the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “about 1 to 5” should be interpreted to include not only the explicitly recited values of about 1 to about 5, but should also be interpreted to also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as 2, 3 and 4 and sub-ranges such as “about 1 to about 3,” “about 2 to about 4” and “about 3 to about 5,” “1 to 3,” “2 to 4,” “3 to 5,” etc. This same principle applies to ranges reciting only one numerical value (e.g., “greater than about 1”) and should apply regardless of the breadth of the range or the characteristics being described. A plurality of items may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member. Thus, no individual member of such list should be construed as a de facto equivalent of any other member of the same list solely based on their presentation in a common group without indications to the contrary. Furthermore, where the terms “and” and “or” are used in conjunction with a list of items, they are to be interpreted broadly, in that any one or more of the listed items may be used alone or in combination with other listed items. The term “alternatively” refers to selection of one of two or more alternatives, and is not intended to limit the selection to only those listed alternatives or to only one of the listed alternatives at a time, unless the context clearly indicates otherwise.

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 may be made without departing from the spirit and scope of the invention and without diminishing its attendant advantages. For instance, various components may be repositioned as desired. It is therefore intended that such changes and modifications be included within the scope of the invention. Moreover, not all of the features, aspects and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is intended to be defined only by the claims that follow.