# Patent

## Title
Mask system with interchangeable headgear connectors

## Abstract

A mask system for delivering breathable gas to a patient includes a common frame provided without built-in or integral headgear attachment points and at least first and second headgear connectors adapted to be provided to the frame. Each of the at least first and second headgear connectors are adapted to attach headgear straps of headgear. The at least first and second headgear connectors are different from one another in at least one aspect.

## Background
CROSS-REFERENCE TO APPLICATION
This application claims the benefit of U.S. Provisional Application No. 60/898,108, filed Jan. 30, 2007, which is incorporated herein by reference in its entirety.


FIELD OF THE INVENTION
The present invention relates to a mask system used for treatment, e.g., of Sleep Disordered Breathing (SDB) with Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV).
BACKGROUND OF THE INVENTION
Patient interfaces, such as a full-face or nasal mask systems, for use with blowers and flow generators in the treatment of sleep disordered breathing (SDB), typically include a soft face-contacting portion, such as a cushion, and a rigid shell or frame. In use, the interface is held in a sealing position by headgear so as to enable a supply of air at positive pressure (e.g., 2-30 cm H2O) to be delivered to the patient's airways.
One factor in the efficacy of therapy and compliance of patients with therapy is the comfort and fit of the patient interface. It has been necessary to design a wide variety of interfaces to best treat and/or suit the patient's needs. While there are a large number of interfaces, typically each frame has been specifically designed to be used with only a single headgear. That is, only one headgear will work correctly with a given frame due to headgear vectors. This is because the frame will have connection points for the headgear located on the frame, and there is a limited way of routing the headgear off these connection points to achieve correct sealing vectors.
PCT Publication No. WO 02/45784, which is incorporated herein by reference in its entirety, discloses a patient mask assembly including a wire brace which clips to the mask and provides attachment locations for headgear straps in alternative positions to those attachment locations which may be provided by the mask.
The present invention provides alternative arrangements of mask systems to enhance the efficacy of therapy and compliance of patients with therapy.
SUMMARY OF THE INVENTION
One aspect of the invention relates to a mask system that can be adapted for use with a variety of different styles or types of headgear.
Another aspect of the invention relates to a mask system for delivering breathable gas to a patient. The mask system includes a common frame provided without built-in or integral headgear attachment points and at least first and second headgear connectors adapted to be provided to the frame. Each of the at least first and second headgear connectors are adapted to attach headgear straps of headgear. The at least first and second headgear connectors are different from one another in at least one aspect.
Another aspect of the invention relates to a mask system for delivering breathable gas to a patient. The mask system includes at least first and second headgear connectors adapted to attach headgear straps of headgear and a common frame structured to support each of the at least first and second headgear connectors. The at least first and second headgear connectors are different from one another in at least one aspect. Each of the headgear connectors is constructed of a similar material as the frame.
Another aspect of the invention relates to a mask system for delivering breathable gas to a patient. The mask system includes at least first and second headgear connectors adapted to attach headgear straps of headgear and a common frame structured to support each of the at least first and second headgear connectors. The at least first and second headgear connectors are different from one another in at least one aspect. Each of the headgear connectors includes at least one headgear clip receptacle adapted to be engaged with a clip provided to a headgear strap.
Another aspect of the invention relates to a mask system for delivering breathable gas to a patient. The mask system includes at least first and second headgear connectors adapted to attach headgear straps of headgear and a common frame structured to support each of the at least first and second headgear connectors. The at least first and second headgear connectors are different from one another in at least one aspect. The frame includes a central bore adapted to engage an elbow assembly. Each of the headgear connectors includes an opening adapted to removably engage a flange or interfacing structure provided along the central bore of the frame.
Another aspect of the invention relates to a kit including at least first and second headgear connectors adapted to attach headgear straps of headgear, a common frame structured to support each of the at least first and second headgear connectors, a sealing interface or cushion provided to the frame, and at least first and second headgear adapted to attach to a respective one of the at least first and second headgear connectors. The at least first and second headgear connectors are different from one another in at least one aspect.
Another aspect of the invention relates to a method for fitting a mask system to a patient. The method includes providing a common frame without built-in or integral headgear attachment points, selecting headgear based on a preferred headgear style, providing a headgear connector adapted to be provided to the frame and adapted to attach headgear straps of the selected headgear.
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
The accompanying drawings facilitate an understanding of the various embodiments of this invention. In such drawings:
FIGS. 1A- to 1C illustrate a mask system with interchangeable headgear connectors according to an embodiment of the present invention;
FIGS. 1D-1 to 1D-5 illustrate headgear connectors according to alternative embodiments of the present invention;
FIGS. 2A to 5B illustrate a common frame with interchangeable headgear connectors for a mask system according to another embodiment of the present invention;
FIGS. 6A to 6D-2 illustrate a common frame with interchangeable headgear connectors for a mask system according to another embodiment of the present invention; and
FIGS. 7A to 7C illustrate a common frame with interchangeable and slidable headgear connectors for a mask system according to another embodiment of the present invention.



DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS
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, each single feature or combination of features in any of the embodiments may constitute an additional embodiment.
While each embodiment below is described as including a full-face or nasal interface type, each embodiment may be adapted for use with other suitable interface types. That is, the interface type is merely exemplary, and each embodiment may be adapted to include other interface types, e.g., mouth masks, nasal prongs, etc.
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 of”. A corresponding meaning is to be attributed to the corresponding words “comprise”, “comprised” and “comprises” where they appear.
1. First Embodiment of Common Frame and Interchangeable Headgear Connector
FIGS. 1A to 1C illustrate a mask system 10 including interchangeable headgear connectors according to an embodiment of the present invention. In this embodiment, the mask system 10 includes a full-face interface. The mask system 10 includes a common or universal frame 20, a cushion 30 provided to the frame 20 and adapted to form a seal with the patient's face, an elbow assembly 40 provided to the frame 20 and adapted to be connected to an air delivery tube (not shown) that delivers breathable gas to the patient, one of three headgear connectors 50(1), 50(2), 50(3) removably attachable to the frame 20, and one of three headgear 60(1), 60(2), 60(3) removably attachable a respective one of the headgear connectors 50(1), 50(2), 50(3). This arrangement allows multiple headgear styles to be used with one frame so that different headgear may be mixed and matched with the frame, e.g., depending on patient preference and/or fit. The mask system 10 is intended for use in positive pressure therapy for users with obstructive sleep apnea (OSA) or another respiratory disorder.
The common frame 20 includes a main body 22, a lower bore or annular elbow connection seal 24 adapted to engage the elbow assembly 40, a vent assembly 26 for gas washout, and supplemental ports covered by respective port caps 28. Moreover, the common frame 20 is structured to be selectively and removably coupled to one of three headgear connectors 50(1), 50(2), 50(3) adapted for use with a respective headgear 60(1), 60(2), 60(3). The three headgear 60(1), 60(2), 60(3) may differ in at least one respect from one another such that one may be more suitable or preferable for use with one patient, while another may be more suitable or preferable for use with another patient.
Specifically, the frame 20 includes a ledge or other interfacing structure along its peripheral edge that is adapted to removably connect to each of three different headgear connectors 50(1), 50(2), 50(3) (also referred to as headgear attachment clips). For example, the interfacing structure of the frame 20 may engage each headgear connector 50(1), 50(2), 50(3) with a friction fit, snap-fit, mechanical interlock, or other suitable attachment mechanism. The interfacing structure of the frame 20 does not need to be continuous, but is structured such that multiple headgear connectors can connect thereto.
Each headgear connector 50(1), 50(2), 50(3) includes headgear attachment points 55 along its perimeter that differ in at least one respect from the other headgear connectors. That is, each headgear connector 50(1), 50(2), 50(3) includes different headgear attachment points 55 to allow different style headgear to be used therewith and hence with the frame 20. In the illustrated embodiment, each headgear attachment point 55 is in the form of an opening through which a strap of the headgear may pass and be removably connected. In use, a selected one of the headgear connectors 50(1), 50(2), 50(3) is attached to the frame 20, and headgear 60(1), 60(2), 60(3) having headgear straps associated with such headgear connector 50(1), 50(2), 50(3) is attached to the headgear connector 50(1), 50(2), 50(3) to maintain the mask system 10 in a desired position on the patient's face.
In FIG. 1A, the headgear connector 50(1) includes upper and lower attachment points 55 on each side thereof. As illustrated, this headgear connector 50(1) is structured for use with headgear 60(1) including a pair of upper and lower side straps 62, 64 that are attachable to respective upper and lower attachment points 55 of the headgear connector 50(1). In use, the upper side straps 62 extend over the patient's ears and the lower side straps 64 extend below the patient's ears. The headgear 60(1) also includes a rear portion 68 having straps adapted to cup the occiput of the patient's head in use.
In FIG. 1B, the headgear connector 50(2) includes a side attachment point 55 on each side thereof and a top attachment point 55. As illustrated, this headgear connector 50(2) is structured for use with headgear 60(2) including a pair of side straps 62 that are attachable to respective side attachment points 55 and a top strap 66 that is attachable to the top attachment point 55. In use, the side straps 62 extend below the patient's ears and the top strap extends between the patient's eyes and across the patient's forehead. The headgear 60(2) also includes a rear portion 68 adapted to cup the occiput of the patient's head in use.
In FIG. 1C, the headgear connector 50(3) includes a side attachment point 55 on each side thereof. As illustrated, this headgear connector 50(3) is structured for use with headgear 60(3) including a pair of side straps 62 that are attachable to respective side attachment points 55. In use, the side straps 62 extend over the patient's ears. The headgear 60(3) also includes a rear portion 68 having straps adapted to cup the occiput of the patient's head in use.
As shown in FIG. 1C, each side strap 62 includes a rigidizer 65 to improve stability. The rigidizer 65 may be constructed of a rigid or semi-rigid material, e.g., nylon or plastic, and may be attached to the strap in any suitable manner, e.g., stitching, welding, gluing, or mechanically fixed. It should be appreciated that each headgear style may include one or more straps with a rigidizer to improve stability.
In an embodiment, each headgear connector 50(1), 50(2), 50(3) is constructed of a similar material as the frame 20, e.g., substantially rigid, non-malleable, plastic material (e.g., polycarbonate). However, the headgear connectors and frame may be constructed of other suitable materials.
In an embodiment, the headgear connector may also constitute a cushion clip that is adapted to retain the cushion 30 to the frame 20. For example, the headgear connector may include structure similar to the clip disclosed in U.S. Pat. No. 6,412,487, which is incorporated herein by reference in its entirety. However, it should be appreciated that the cushion 30 may be secured to the frame 20 in other suitable manners (such that the cushion cannot be easily removed from the frame, e.g., adhesive or other permanent attachment).
FIGS. 1D-1 to 1D-5 illustrate headgear connectors according to alternative embodiments of the present invention. In FIG. 1D-1, the headgear connector 150(1) is in the form of a cushion clip adapted to retain the cushion 30 to the frame 20. The headgear connector 150(1) includes a plurality of tabs 144 structured to attach to the frame 20 with a snap-fit. Moreover, the headgear connector 150(1) includes openings 155 through which respective straps of the headgear may pass and be removably connected. As illustrated, the openings 155 are arranged similar to those on the headgear connector 50(1) shown in FIG. 1A.
In FIG. 1D-2, the headgear connector 150(2) is in the form of a cushion clip adapted to retain the cushion 30 to the frame 20. The headgear connector 150(2) includes a plurality of tabs 144 structured to attach to the frame 20 with a snap-fit. Moreover, the headgear connector 150(2) includes anchors or cross-bars 146 for attaching respective straps of the headgear. As illustrated, the anchors 146 are arranged similar to the openings on the headgear connector 50(1) shown in FIG. 1A.
In FIG. 1D-3, the headgear connector 150(3) is in the form of a cushion clip adapted to retain the cushion 30 to the frame 20. The headgear connector 150(3) includes a plurality of tabs 144 structured to attach to the frame 20 with a snap-fit. Moreover, the headgear connector 150(3) includes anchors or cross-bars 146 for attaching respective straps of the headgear. As illustrated, the anchors 146 are arranged similar to the openings on the headgear connector 50(2) shown in FIG. 1B.
In FIG. 1D-4, the headgear connector 150(4) is in the form of a cushion clip adapted to retain the cushion 30 to the frame 20. The headgear connector 150(4) includes a plurality of tabs 144 structured to attach to the frame 20 with a snap-fit. Moreover, the headgear connector 150(4) includes anchors or cross-bars 146 for attaching respective straps of the headgear. As illustrated, the anchors 146 are arranged similar to the openings on the headgear connector 50(3) shown in FIG. 1C.
In FIG. 1D-5, the headgear connector 150(5) is in the form of a cushion clip adapted to retain the cushion 30 to the frame 20. The headgear connector 150(5) includes a plurality of tabs 144 structured to attach to the frame 20 with a snap-fit. Moreover, the headgear connector 150(5) includes anchors or cross-bars 146 for attaching respective side straps of the headgear. In addition, the headgear connector 150(5) includes an extension 148 that provides a plurality of openings 149 for attaching one or more upper straps of the headgear.
It should be appreciated that the illustrated headgear 60(1), 60(2), 60(3) are merely exemplary and other headgear arrangements are possible for use with the illustrated headgear connectors. Also, while the mask system is described as including three different headgear connectors for use with respective headgear, it should be appreciated that the mask system may include any suitable number of headgear connectors for use with associated headgear, e.g., at least two headgear connectors.
The common or universal frame 20 is advantageous since it works with a plurality of different headgear via a respective headgear connector, thereby eliminating the need to specifically make the frame for a particular headgear, as is the standard. That is, the mask or frame/cushion/elbow sub-assembly is independent of the headgear, which allows independent selection of the frame/cushion/elbow sub-assembly and the headgear. Therefore, the frame/cushion/elbow sub-assembly may be selected based on the desired mask seal of the patient and the headgear may be selected based on the desired fit or support arrangement. This allows the patient to achieve both a good seal and a secure, comfortable fit, rather than compromising between one or the other, as is typically the case. This arrangement improves comfort, efficacy of treatment, and compliance. In addition, the attachment points provided by the headgear connector are associated with a specific headgear so that correct sealing vectors may be achieved.
In an embodiment, the frame/cushion/elbow sub-assembly may be provided separately from the headgear connector 50(1), 50(2), 50(3) and associated headgear 60(1), 60(2), 60(3) (e.g., sold separately). This arrangement allows the patient to select headgear based on a preferred headgear style, and then be provided with an associated headgear connector for connection to the frame/cushion/elbow sub-assembly.
2. Second Embodiment of Common Frame and Interchangeable Headgear Connector
FIGS. 2A to 5B illustrate a common or universal frame 220 with interchangeable headgear connectors 250(1), 250(2), 250(3), 250(4) for a mask system according to another embodiment of the present invention. In this embodiment, the mask system includes a nasal interface. Similar to the embodiment described above, this arrangement allows multiple headgear styles to be used with one frame so that different headgear may be mixed and matched with the frame, e.g., depending on patient preference and/or fit. In addition, this arrangement allows the use of different accessories, e.g., forehead support.
The common frame 220 includes a main body 222 and a central bore or annular elbow connection seal 224 adapted to engage an elbow assembly. Moreover, the common frame 220 is structured to be selectively and removably coupled to one of multiple headgear connectors 250(1), 250(2), 250(3), 250(4) adapted for use with a respective headgear and/or accessory.
Specifically, the central bore 224 of the frame 220 includes a flange or interfacing structure 225 along its peripheral edge that is adapted to removably connect to each of the multiple headgear connectors 250(1), 250(2), 250(3), 250(4) (also referred to as headgear attachment clips). In the illustrated embodiment, each headgear connector 250(1), 250(2), 250(3), 250(4) includes an opening 252 adapted to engage the interfacing structure 225 with a friction fit, snap-fit, mechanical interlock, or other suitable attachment mechanism. However, other suitable arrangements for attaching each headgear connector to the frame are possible.
Each headgear connector 250(1), 250(2), 250(3), 250(4) includes headgear and/or accessory attachment points along its perimeter that differ in at least one respect from the other headgear connectors. That is, each headgear connector 250(1), 250(2), 250(3), 250(4) includes different headgear and/or accessory attachment points to allow different style headgear and/or accessories to be used therewith and hence with the frame 220. In use, a selected one of the headgear connectors 250(1), 250(2), 250(3), 250(4) is attached to the frame 220, and headgear or accessories associated with such headgear connector 250(1), 250(2), 250(3), 250(4) is attached to the headgear connector 250(1), 250(2), 250(3), 250(4) to maintain the mask system in a desired position on the patient's face.
While the mask system is described as including four different headgear connectors 250(1), 250(2), 250(3), 250(4) for use with respective headgear and/or accessories, it should be appreciated that the mask system may include any suitable number of headgear connectors for use with associated headgear and/or accessories, e.g., at least two headgear connectors.
2.1 Headgear Connector with Adjustable Forehead Support
In FIGS. 2A-2B, the headgear connector 250(1) is structured to allow the use of an adjustable forehead support. Specifically, the headgear connector 250(1) includes an upper support member or interface 270 adapted to support a forehead support 272 (e.g., see FIG. 2B), lower headgear clip receptacles 274 adapted to be engaged with respective clips 276 (e.g., see FIG. 2B) provided to lower side straps of the headgear (not shown), and the opening 252 structured to engage the interfacing structure 225 of the frame 220.
In use, the headgear connector 250(1) is attached to the frame 220, the forehead support 272 is adjustably mounted to the upper support member 270 of the headgear connector 250(1) to provide a support and stability mechanism between the mask system and the patient's forehead, and headgear having headgear straps associated with such headgear connector 250(1) and forehead support 272 is attached to the headgear connector 250(1) and forehead support 272 to maintain the mask system in a desired position on the patient's face. As illustrated, the headgear connector 250(1) and forehead support 272 are structured for use with headgear including a pair of lower side straps attached to respective clips 276 and a pair of upper side straps attached to respective openings 273 on the forehead support 272.
2.2 Headgear Connector with Fixed Forehead Support
In FIGS. 3A-3B, the headgear connector 250(2) includes a fixed forehead support. Specifically, the headgear connector 250(2) includes a fixed forehead support 272 having openings 273 for attaching respective upper side straps of the headgear, lower headgear clip receptacles 274 adapted to be engaged with respective clips 276 (e.g., see FIG. 3B) provided to lower side straps of the headgear (not shown), and the opening 252 structured to engage the interfacing structure 225 of the frame 220.
In use, the headgear connector 250(2) is attached to the frame 220 and headgear having headgear straps associated with such headgear connector 250(2) is attached to the headgear connector 250(2) to maintain the mask system in a desired position on the patient's face. As illustrated, the headgear connector 250(2) and its fixed forehead support 272 are structured for use with headgear including a pair of lower side straps attached to respective clips 276 and a pair of upper side straps attached to respective openings 273 on the fixed forehead support 272.
2.3 Symmetrical Headgear Connector
In FIGS. 4A-4B, the headgear connector 250(3) includes a substantially symmetrical arrangement. Specifically, the headgear connector 250(3) includes headgear clip receptacles 274 on each side thereof adapted to be engaged with clips (not shown) provided to side straps of the headgear (not shown) and the opening 252 structured to engage the interfacing structure 225 of the frame 220.
In use, the headgear connector 250(3) is attached to the frame 220 and headgear having headgear straps associated with such headgear connector 250(3) is attached to the headgear connector 250(3) to maintain the mask system in a desired position on the patient's face. As illustrated, the headgear connector 250(3) is structured for use with headgear including a pair of side straps attached to respective clips associated with the clip receptacles 274.
The headgear connector 250(3) is substantially symmetrical about its horizontal and vertical axes such that it may be rotated between two positions with respect to the frame 220, i.e., rotated 180° about its center. In each position, the headgear clip receptacles 274 will be correctly oriented, i.e., extend laterally.
2.4 Headgear Connector with Chin Support/Mouth Seal/Mandibular Device
In FIGS. 5A-5B, the headgear connector 250(4) is structured to allow the use of an adjustable forehead support and a chin support, mouth seal, and/or mandibular device, for example. Specifically, the headgear connector 250(4) includes an upper support member or interface 270 adapted to support a forehead support (e.g., such as the forehead support 272 shown in FIG. 2B), lower headgear clip receptacles 274 adapted to be engaged with clips (e.g., such as the clips 276 shown in FIG. 2B) provided to lower side straps of the headgear (not shown), the opening 252 structured to engage the interfacing structure 225 of the frame 220, and a lower clip receptacle 278 positioned at the bottom of the headgear connector 250(4) between the headgear clip receptacles 274 and adapted to be engaged with a clip provided to a chin support, mouth seal, and/or mandibular device, for example.
In use, the headgear connector 250(4) is attached to the frame 220, a forehead support is adjustably mounted to the upper support member 270 of the headgear connector 250(4) to provide a support and stability mechanism between the mask system and the patient's forehead, a chin support, mouth seal, and/or mandibular device, for example, is attached to the headgear connector 250(4) via the lower clip receptacle 278, and headgear having headgear straps associated with such headgear connector 250(4) and forehead support is attached to the headgear connector 250(4) and forehead support to maintain the mask system in a desired position on the patient's face. The headgear connector 250(4) and forehead support are structured for use with headgear including a pair of lower side straps attached to respective clips associated with the clip receptacles 274 and a pair of upper side straps attached to the forehead support.
The lower clip receptacle 278 allows the attachment of devices structured to be positioned at the bottom of the mask system, e.g., below the nose and/or mouth. As noted above, such devices may include a chin support, mouth seal, and/or mandibular device. However, the lower clip receptacle 278 may be structured to support other suitable devices, e.g., chin restraint, chin strap, etc.
2.5 Alternatives
In alternative embodiments, each headgear connector 250(1), 250(2), 250(3), 250(4) may provide openings in place of headgear clip receptacles through which straps of the headgear may pass and be removably connected, e.g., if headgear clips are not desired. Also, the forehead support provided to associated headgear connectors may provide headgear clip receptacles in place of openings for attaching headgear straps.
3. Third Embodiment of Common Frame and Interchangeable Headgear Connector
FIGS. 6A to 6D-2 illustrate a common or universal frame 320 with interchangeable headgear connectors 350(1), 350(2), 350(3) for a mask system according to another embodiment of the present invention. In this embodiment, the mask system includes a nasal interface. Similar to the embodiments described above, this arrangement allows multiple headgear styles to be used with one frame so that different headgear may be mixed and matched with the frame, e.g., depending on patient preference and/or fit.
The common frame 320 includes a main body 322 and a central bore or annular elbow connection seal 324 adapted to engage an elbow assembly. Moreover, the common frame 320 is structured to be selectively and removably coupled to one or more headgear connectors 350(1), 350(2), 350(3) (also referred to as attachment clips). The one or more headgear connectors 350(1), 350(2), 350(3) are selectively arranged on the frame 320 for use with a respective headgear.
Specifically, the frame 320 includes multiple interfacing structures 380(1), 380(2), 380(3) that are adapted to removably connect to a respective one of the headgear connectors 350(1), 350(2), 350(3). The interfacing structures 380(1), 380(2), 380(3) are located in various positions around the frame 320 so that the headgear connectors 350(1), 350(2), 350(3) are attachable to the frame 320 in different positions with respect to one another for use with different headgear arrangements.
In the illustrated embodiment, each interfacing structure 380(1), 380(2), 380(3) provides one or more protrusions having a profile, shape, or arrangement that differs in at least one respect from the other interfacing structures. For example, the first interfacing structure 380(1) at the upper side of the frame provides an elongated, oval-shaped protrusion, the second interfacing structure 380(2) at the lower side of the frame provides an hourglass-shaped or number eight-shaped protrusion, and the third interfacing structure 380(3) at the top of the frame provides spaced apart pegs or pins.
Each headgear connector 350(1), 350(2), 350(3) includes one or more openings having a profile, shape, or arrangement that corresponds to a respective one of the interfacing structures 380(1), 380(2), 380(3). Thus, each headgear connector 350(1), 350(2), 350(3) may attach to the frame in only one orientation to prevent misassembly. That is, the profile, shape, or arrangement of the protrusion/opening provides a keyed arrangement to facilitate assembly of the headgear connector to the frame in the correct position and orientation.
In FIGS. 6B-1 and 6B-2, the headgear connector 350(1) includes a headgear clip receptacle 354 adapted to be engaged with a clip (not shown) provided to a strap of the headgear (not shown), an elongated, oval-shaped opening 356(1) adapted to be engaged with the first interfacing structure 380(1) at the upper side of the frame, and a cutout 358(1) adapted to be engaged with an upper portion of the second interfacing structure 380(2) at the lower side of the frame. The opening 356(1) and cutout 358(1) of the headgear connector 350(1) may engage respective interfacing structures 380(1), 380(2) with a friction fit, snap-fit, and/or mechanical interlock, for example.
In FIGS. 6C-1 and 6C-2, the headgear connector 350(2) includes a headgear clip receptacle 354 adapted to be engaged with a clip (not shown) provided to a strap of the headgear (not shown), an hourglass-shaped or number eight-shaped opening 356(2) adapted to be engaged with the second interfacing structure 380(2) at the lower side of the frame, and a cutout 358(2) adapted to be engaged with a lower portion of the first interfacing structure 380(1) at the upper side of the frame. The opening 356(2) and cutout 358(2) of the headgear connector 350(2) may engage respective interfacing structures 380(2), 380(1) with a friction fit, snap-fit, and/or mechanical interlock, for example.
In FIGS. 6D-1 and 6D-2, the headgear connector 350(3) is in the form of a forehead support including spaced apart openings 356(3) adapted to be engaged with respective pegs of the third interfacing structure 380(3) at the top of the frame and openings for attaching respective straps of the headgear. The openings 356(3) of the headgear connector 350(3) may engage respective pegs of the third interfacing structure 380(3) with a friction fit, snap-fit, and/or mechanical interlock, for example.
It should be appreciated that the headgear connectors may have other suitable styles or arrangements. For example, rather than a forehead support, the headgear connector 350(3) may provide an upper headgear clip receptacle or an upper support member adapted to support a forehead support. Also, in an alternative embodiment, a vertical headgear strap may be structured to directly engage the pegs of the third interfacing structure 380(3).
In use, headgear connectors are selected for use with a particular headgear. That is, each different style of headgear may be associated with headgear connectors having features (i.e., openings having a unique profile, shape, or arrangement) that prevent them from being assembled to the frame in the incorrect position. For example, the headgear connector 350(1) shown in FIGS. 6B-1 and 6B-2 may be associated with headgear having side straps adapted to be positioned at an upper side of the frame 320. The opening 356(1) and cutout 358(1) of the headgear connector 350(1) provide a unique shape that ensures that headgear connector 350(1) is connected to the frame 320 at first interfacing structure 380(1) on an upper side of the frame, rather than at the second interfacing structure 380(2) on a lower side of the frame 320 (i.e., protrusion 380(1) only allows opening 356(1) to pass). The headgear connector 350(3) providing a forehead support may be attached to the top of the frame when headgear having upper side straps is provided, for example.
Thus, the protrusion/opening arrangement (also referred to as poka-yoke design) ensures that only the correct positioning of the headgear connectors for a particular headgear can take place. This arrangement ensures that headgear is correctly assembled to the frame, which leads to correct sealing vectors and improved comfort.
It should be appreciated that the protrusion/opening may have other suitable shapes, and the protrusions may be located in other suitable positions on the frame for attaching headgear connectors or other suitable accessories. In addition, the positioning of the protrusion/opening may be reversed, e.g., opening on frame and protrusion on headgear connector.
4. Fourth Embodiment of Common Frame and Interchangeable Headgear Connector
FIGS. 7A to 7C illustrate a common or universal frame 420 with interchangeable and/or slidable headgear connectors 450 for a mask system according to another embodiment of the present invention. In this embodiment, the mask system includes a nasal interface. Similar to the embodiments described above, this arrangement allows multiple headgear styles to be used with one frame so that different headgear may be mixed and matched with the frame, e.g., depending on patient preference and/or fit.
The common frame 420 includes a main body 422 and a central bore or annular elbow connection seal 424 adapted to engage an elbow assembly. Moreover, the common frame 420 is structured to be selectively and removably coupled to one or more headgear connectors 450 (also referred to as attachment clips or sliders). The one or more headgear connectors 450 are selectively arranged on the frame 420 for use with a respective headgear.
Specifically, the frame 420 includes a slider support structure 490 adapted to removably and slidably support one or more headgear connectors 450. Each headgear connectors 450 is slidable along the slider support structure 490 to one of multiple positions. This arrangement allows one or more headgear connectors 450 to be attached to the frame in different positions for use with different headgear arrangements.
In the illustrated embodiment, the slider support structure 490 extends along side and top portions of the frame. However, other suitable arrangements are possible, e.g., slider support structure provided along bottom portion of the frame. As best shown in FIG. 7B-1, the slider support structure 490 includes spaced apart walls 492 each having an inwardly directed flange 494 to prevent the one or more headgear connectors 450 from being pulled outwardly from the frame.
Each headgear connector 450 includes a T-shaped portion 402 adapted to be slidably engaged with the slider support structure 490 (e.g., see FIG. 7B-1) and a clip receptacle 404 adapted to be engaged with a clip (not shown). The clip may be provided to a strap of the headgear or other accessory, e.g., forehead support.
In use, one or more headgear connectors 450 are positioned on the frame 420 for use with a particular headgear. That is, one or more headgear connectors 450 are slid along the slider support structure 490 to a certain position, e.g., depending on the headgear arrangement. The slider support structure and/or headgear connector may include a locking arrangement to lock the headgear connector in position. For example, the headgear connector 450 may be rotatable with respect to the slider support structure 490 between unlocked and locked positions. FIG. 7B-2 shows the headgear connector 450 in an unlocked position that allows the headgear connector 450 to slide freely along the slider support structure 490, and FIG. 7B-3 shows the headgear connector 450 rotated or spun to a locked position that locks the headgear connector 450 in position. In an alternative embodiment, a screw or movable locking member (e.g., push-button release) may be provided to the headgear connector that is adapted to engage the slider support structure to lock the headgear connector in position.
Also, alignment indicators may be provided to the slider support structure and/or headgear connector to indicate the headgear connector's position. In an embodiment, the headgear may be provided with a particular setting of the headgear connectors' positioning.
FIG. 7C illustrates an embodiment of a slider support structure 490 wherein each flange 494 includes a scalloped edge 495. In such an arrangement, each headgear connector may include an interface adapted to be squeezed between the opposing scalloped edges 495. For example, as shown in FIG. 7C, the headgear connector may include a ratcheting mechanism 405 including end portions 407 adapted to engage the edges 495 and a biasing member 409 (e.g., spring) adapted to resiliently bias or force the end portions 407 into engagement with the edges 495. In use, the scalloped edges 495 will hold the ratcheting mechanism 405 in a desired position (as shown in solid lines) and the ratcheting mechanism 495 may be squeezed so that it can compress and move along the slider support structure 490 into another position (as shown in dashed lines). The scalloped edges 495 may provide audible feedback as the headgear connector is slid to a desired position, e.g., clicking.
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 may be 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, barriatric 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

1. A mask system for delivering breathable gas to a patient, comprising:
a common frame provided without built-in or integral headgear attachment points; and
at least first and second headgear connectors adapted to be provided to the frame, each of said at least first and second headgear connectors adapted to attach headgear straps of headgear, and said at least first and second headgear connectors being different from one another in at least one aspect,
wherein each of the first and second headgear connectors is adapted to be removably connected to the frame so as to prevent movement of each of the at least first and second headgear connectors with respect to the frame,
wherein each of said headgear connectors includes an adjustable forehead support or an upper support member adapted to support an adjustable forehead support.

2. The mask system according to claim 1, wherein each of said headgear connectors is constructed of a similar material as the frame.

3. The mask system according to claim 2, wherein each of said headgear connectors and the frame are constructed of a substantially rigid plastic material.

4. The mask system according to claim 3, wherein each of said headgear connectors and the frame are constructed of polycarbonate.

5. The mask system according to claim 1, wherein said at least first and second headgear connectors include headgear attachment points that differ in at least one respect from one another.

6. The mask system according to claim 5, wherein each of the headgear attachment points is in the form of an opening adapted to receive a headgear strap therethrough.

7. The mask system according to claim 5, wherein at least one of said headgear connectors includes upper and lower attachment points on each side thereof.

8. The mask system according to claim 5, wherein at least one of said headgear connectors includes a side attachment point on each side thereof and a top attachment point.

9. The mask system according to claim 5, wherein at least one of said headgear connectors includes a side attachment point on each side thereof.

10. The mask system according to claim 1, wherein each of said headgear connectors is structured to removably connect to the frame with a friction fit, snap-fit, mechanical interlock, and/or other attachment mechanism.

11. The mask system according to claim 1, further comprising at least first and second headgear adapted to attach to a respective one of said at least first and second headgear connectors, said at least first and second headgear being different from one another in at least one aspect.

12. The mask system according to claim 1, wherein each of said headgear connectors includes headgear clip receptacles and/or a clip receptacle adapted to support an accessory.

13. The mask system according to claim 1, wherein if at least one of said headgear connectors includes an upper support member adapted to support an adjustable forehead support, said headgear connector having openings for attaching upper side straps of the headgear and lower headgear clip receptacles adapted to be engaged with respective clips provided to lower side straps of the headgear.

14. The mask system according to claim 1, wherein if at least one of said headgear connectors includes an adjustable fixed forehead support, said headgear connector having openings adapted to attach upper side straps of the headgear and lower headgear clip receptacles adapted to be engaged with respective clips provided to lower side straps of the headgear.

15. The mask system according to claim 12, wherein if at least one of said headgear connectors includes headgear clip receptacles, said headgear connector including headgear clip receptacles on each side thereof adapted to be engaged with clips provided to side straps of the headgear.

16. The mask system according to claim 12, wherein if at least one of said headgear connectors includes an upper support member adapted to support a forehead support, said headgear connector having openings for attaching upper side straps of the headgear, lower headgear clip receptacles adapted to be engaged with respective clips provided to lower side straps of the headgear, and a lower clip receptacle positioned at the bottom of the headgear connector between the headgear clip receptacles and adapted to be engaged with a clip provided to an accessory.

17. The mask system according to claim 16, wherein the accessory includes a chin support, a mouth seal, and/or a mandibular device.

18. The mask system according to claim 1, wherein the frame includes at least two interfacing structures located in different positions on the frame and said at least first and second headgear connectors is adapted to be removably connected to a respective one of the interfacing structures.

19. The mask system according to claim 18, wherein each interfacing structure provides one or more protrusions having a profile, shape, or arrangement that differs in at least one respect from the other interfacing structures, and each headgear connector includes one or more openings having a profile, shape, or arrangement that corresponds to a respective one of the interfacing structures.

20. The mask system according to claim 18, wherein each of said headgear connectors includes headgear clip receptacles.

21. A mask system for delivering breathable gas to a patient, comprising:
at least first and second headgear connectors adapted to attach headgear straps of headgear, said at least first and second headgear connectors being different from one another in at least one aspect; and
a common frame structured to support each of said at least first and second headgear connectors,
wherein each of said headgear connectors is constructed of a similar material as the frame, and each of the first and second headgear connectors is adapted to be removably connected to the frame so as to prevent movement of each of the at least first and second headgear connectors with respect to the frame,
wherein each of said headgear connectors includes an adjustable forehead support or an upper support member adapted to support an adjustable forehead support.

22. The mask system according to claim 21, wherein each of said headgear connectors is constructed of a substantially rigid, non-malleable, plastic material.

23. The mask system according to claim 22, wherein each of said headgear connectors is constructed of polycarbonate.

24. A mask system for delivering breathable gas to a patient, comprising:
at least first and second headgear connectors adapted to attach headgear straps of headgear, said at least first and second headgear connectors being different from one another in at least one aspect; and
a common frame structured to support each of said at least first and second headgear connectors,
wherein each of said headgear connectors includes at least one headgear clip receptacle adapted to be engaged with a clip provided to a headgear strap, and each of the first and second headgear connectors is adapted to be removably connected to the frame so as to prevent movement of each of the at least first and second headgear connectors with respect to the frame.

25. A mask system for delivering breathable gas to a patient, comprising:
at least first and second headgear connectors adapted to attach headgear straps of headgear, said at least first and second headgear connectors being different from one another in at least one aspect; and
a common frame structured to support each of said at least first and second headgear connectors, the frame including a central bore adapted to engage an elbow assembly,
wherein each of said headgear connectors includes an opening adapted to removably engage a flange or interfacing structure provided along the central bore of the frame, and each of the first and second headgear connectors is adapted to be removably connected to the flange or interfacing structure of the frame so as to prevent movement of each of the at least first and second headgear connectors with respect to the frame.

26. A kit comprising:
at least first and second headgear connectors adapted to attach headgear straps of headgear, said at least first and second headgear connectors being different from one another in at least one aspect;
a common frame structured to support each of said at least first and second headgear connectors, wherein each of the first and second headgear connectors is adapted to be removably connected to the frame so as to prevent movement of each of the at least first and second headgear connectors with respect to the frame;
a sealing interface or cushion provided to the frame; and
at least first and second headgear adapted to attach to a respective one of said at least first and second headgear connectors,
wherein each of said headgear connectors includes an adjustable forehead support or an upper support member adapted to support an adjustable forehead support.

27. A method for fitting a mask system to a patient, comprising:
providing a common frame without built-in or integral headgear attachment points;
selecting headgear from at least first and second headgear based on a preferred headgear style; and
selecting a headgear connector from at least first and second headgear connectors being different from one another in at least one aspect, the selected headgear connector adapted to be removably connected to the frame so as to prevent movement of each of the at least first and second headgear connectors with respect to the frame and structured to attach headgear straps of the selected headgear,
wherein each of said headgear connectors includes an adjustable forehead support or an upper support member adapted to support an adjustable forehead support.

28. A mask system for delivering breathable gas to a patient, comprising:
a common frame provided without built-in or integral headgear attachment points, said frame having at least one retention feature; and
at least first and second headgear connectors adapted to be connected to the at least one retention feature of the frame at a mounting point of the frame, each of said at least first and second headgear connectors adapted to attach headgear straps of headgear, and said at least first and second headgear connectors being different from one another in at least one aspect,
wherein the at least first and second headgear connectors are structured to rotate up to a maximum of 180° about the mounting point of the frame.

29. A mask system for delivering breathable gas to a patient, comprising:
a common frame provided without built-in or integral headgear attachment points;
a cushion adapted to contact the face of the patient; and
at least first and second headgear connectors adapted to be provided to the frame, each of said at least first and second headgear connectors adapted to attach headgear straps of headgear, and said at least first and second headgear connectors being different from one another in at least one aspect,
wherein the at least first and second headgear connectors are adapted to retain the cushion to the frame.

30. The mask system according to claim 29, wherein each of said headgear connectors is constructed of a similar material as the frame.

31. The mask system according to claim 30, wherein each of said headgear connectors and the frame is constructed of a substantially rigid plastic material.

32. The mask system according to claim 31, wherein each of said headgear connectors and the frame is constructed of polycarbonate.

33. The mask system according to claim 29, wherein said at least first and second headgear connectors include headgear attachment points that differ in at least one respect from one another.

34. The mask system according to claim 32, wherein each headgear attachment point is in the form of an opening adapted to receive a headgear strap therethrough.

35. The mask system according to claim 32, wherein at least one of said headgear connectors includes upper and lower attachment points on each side thereof.

36. The mask system according to claim 32, wherein at least one of said headgear connectors includes a side attachment point on each side thereof and a top attachment point.

37. The mask system according to claim 32, wherein at least one of said headgear connectors includes a side attachment point on each side thereof.

38. The mask system according to claim 29, wherein each of said headgear connectors are structured to engage the frame with a friction fit, snap-fit, mechanical interlock, and/or other attachment mechanism.

39. The mask system according to claim 29, further comprising at least first and second headgear adapted to attach to a respective one of said at least first and second headgear connectors, said at least first and second headgear being different from one another in at least one aspect.

40. The mask system of claim 1, having attachment points fixed relative to the frame.

41. The mask system according to claim 1, wherein at least one of said at least first and second headgear connectors including headgear clip receptacles adapted to attach to respective clips attached to respective side straps of a headgear.

42. A mask system for delivering breathable gas to a patient, comprising:
a common frame provided without built-in or integral headgear attachment points; and
at least first and second headgear connectors adapted to be provided to the frame, each of said at least first and second headgear connectors adapted to attach headgear straps of headgear, and said at least first and second headgear connectors being different from one another in at least one aspect; wherein each of the first and second headgear connectors is adapted to be connected to the frame, wherein the at least one retention feature comprises a slider support structure and each headgear connector includes structure adapted to be removably and slidably engaged with the slider support structure.

43. The mask system according to claim 42, wherein each headgear connector is adapted to be slid along the slider support structure to one of multiple positions.

44. The mask system according to claim 42, wherein each headgear connector includes a headgear clip receptacle.

45. A mask system for delivering breathable gas to a patient at positive pressure to treat sleep disordered breathing, the mask system comprising:
a mask frame having a central bore, said mask frame having no built-in or integral headgear attachment points;
a sealing cushion provided to the frame and adapted to form a seal with the patient's face;
a headgear including a pair of upper side straps, a pair of lower side straps, and a rear portion;
a pair of lower headgear clips adapted to receive respective ones of the pair of lower side straps; and
a headgear connector adapted to engage the mask frame, said headgear connector including a pair of lower headgear clip anchors adapted to be engaged with respective ones of the pair of lower headgear clips, said headgear connector including an adjustable forehead support connected to the headgear connector by an upper support member, said adjustable forehead support including a pair of openings adapted to attach to respective ones of the upper side straps,
wherein the mask frame is adapted to removably connect to more than one headgear connector, each headgear connector being different in at least one aspect.

46. The mask system according to claim 45, wherein the mask frame and the sealing cushion comprise a full-face mask.

47. The mask system according to claim 46, wherein the sealing cushion is secured to the mask frame.

48. The mask system according to claim 47, wherein at least a portion of said headgear connector is shaped to conform to a portion of said mask frame.

49. The mask system according to claim 48, wherein the mask frame includes a peripheral edge to engage the headgear connector.

50. The mask system according to claim 45, comprising an elbow assembly, said elbow assembly being adapted to be connected to an air delivery tube.

51. The mask system according to claim 45, wherein the headgear connector is removably attachable to the mask frame.

52. The mask system according to claim 51, wherein when said mask frame and said headgear connector are attached, the mask frame and the headgear connector are not movable relative to one another.

53. The mask system according to claim 51, wherein the headgear connector and the mask frame are adapted to be engaged by a snap-fit.

54. The mask system according to claim 51, wherein the headgear connector comprises a plurality of tabs to attach the mask frame with a snap-fit.

55. The mask system according to claim 45, wherein the central bore is located on a main body of the mask frame.

56. The mask system according to claim 45, comprising a vent assembly for gas washout.

57. The mask system according to claim 45, wherein the adjustable forehead support is T-shaped.

58. The mask system according to claim 45, wherein the pair of upper side straps are arranged to extend above the patient's ears and the pair of lower side straps are arranged to extend below the patient's ears.

59. The mask system according to claim 58, wherein the rear portion of the headgear is adapted to cup the occiput of the patient's head.

60. The mask system according to claim 45, wherein the sealing cushion cannot be easily detached from the mask frame.

61. The mask system according to claim 60, wherein the sealing cushion and the mask frame are permanently attached.

62. The mask system according to claim 45, wherein said headgear connector is constructed of a similar material as the frame.

63. The mask system according to claim 62, wherein said headgear connector and said mask frame are constructed of a substantially rigid, non-malleable plastic material.

64. The mask system according to claim 63, wherein said headgear connector and said mask frame are constructed of polycarbonate.

65. The mask system according to claim 45, comprising a vent assembly for gas washout,
wherein the headgear connector is removably attachable to the mask frame,
wherein when said mask frame and said headgear connector are attached, the mask frame and the headgear connector are not movable relative to one another,
wherein the headgear connector and the mask frame are adapted to be engaged by a snap- fit,
wherein the adjustable forehead support is T-shaped,
wherein the pair of upper side straps are arranged to extend above the patient's ears and the pair of lower side straps are arranged to extend below the patient's ears, and
wherein said headgear connector and said mask frame are constructed of polycarbonate.

66. The mask system according to claim 45, wherein the mask frame and the sealing cushion comprise a full-face mask,
wherein the sealing cushion is secured to the mask frame,
wherein the mask system comprises an elbow assembly, said elbow assembly being adapted to be connected to an air delivery tube,
wherein the headgear connector is removably attachable to the mask frame,
wherein when said mask frame and said headgear connector are attached, the mask frame and the headgear connector are not movable relative to one another,
wherein the headgear connector and the mask frame are adapted to be engaged by a snap- fit,
wherein the central bore is located on a main body of the mask frame,
wherein the mask system comprises a vent assembly for gas washout,
wherein the adjustable forehead support is T-shaped,
wherein the pair of upper side straps are arranged to extend above the patient's ears and the pair of lower side straps are arranged to extend below the patient's ears,
wherein the rear portion of the headgear is adapted to cup the occiput of the patient's head,
wherein at least a portion of said headgear connector is shaped to conform to a portion of said mask frame, and
wherein said headgear connector and said mask frame are constructed of a substantially rigid, non-malleable plastic material.