Patent Description:
Many individuals suffer from disordered breathing during sleep. Sleep apnea is a common example of such sleep disordered breathing suffered by millions of people throughout the world. One type of sleep apnea is obstructive sleep apnea (OSA), which is a condition in which sleep is repeatedly interrupted by an inability to breathe due to an obstruction of the airway; typically the upper airway or pharyngeal area. Obstruction of the airway is generally believed to be due, at least in part, to a general relaxation of the muscles which stabilize the upper airway segment, thereby allowing the tissues to collapse the airway. Another type of sleep apnea syndrome is a central apnea, which is a cessation of respiration due to the absence of respiratory signals from the brain's respiratory center. An apnea condition, whether obstructive, central, or mixed, which is a combination of obstructive and central, is defined as the complete or near cessation of breathing, for example a <NUM>% or greater reduction in peak respiratory air-flow.

Those afflicted with sleep apnea experience sleep fragmentation and complete or nearly complete cessation of ventilation intermittently during sleep with potentially severe degrees of oxyhemoglobin desaturation. These symptoms may be translated clinically into extreme daytime sleepiness, cardiac arrhythmias, pulmonary-artery hypertension, congestive heart failure and/or cognitive dysfunction. Other consequences of sleep apnea include right ventricular dysfunction, carbon dioxide retention during wakefulness, as well as during sleep, and continuous reduced arterial oxygen tension. Sleep apnea sufferers may be at risk for excessive mortality from these factors as well as by an elevated risk for accidents while driving and/or operating potentially dangerous equipment.

Even if a patient does not suffer from a complete or nearly complete obstruction of the airway, it is also known that adverse effects, such as arousals from sleep, can occur where there is only a partial obstruction of the airway. Partial obstruction of the airway typically results in shallow breathing referred to as a hypopnea. A hypopnea is typically defined as a <NUM>% or greater reduction in the peak respiratory air-flow. Other types of sleep disordered breathing include, without limitation, upper airway resistance syndrome (UARS) and vibration of the airway, such as vibration of the pharyngeal wall, commonly referred to as snoring.

It is well known to treat sleep disordered breathing by applying a continuous positive air pressure (CPAP) to the patient's airway. This positive pressure effectively "splints" the airway, thereby maintaining an open passage to the lungs. It is also known to provide a positive pressure therapy in which the pressure of gas delivered to the patient varies with the patient's breathing cycle, or varies with the patient's breathing effort, to increase the comfort to the patient. This pressure support technique is referred to as bi-level pressure support, in which the inspiratory positive airway pressure (IPAP) delivered to the patient is higher than the expiratory positive airway pressure (EPAP). It is further known to provide a positive pressure therapy in which the pressure is automatically adjusted based on the detected conditions of the patient, such as whether the patient is experiencing an apnea and/or hypopnea. This pressure support technique is referred to as an auto-titration type of pressure support, because the pressure support device seeks to provide a pressure to the patient that is only as high as necessary to treat the disordered breathing.

Pressure support therapies as just described involve the placement of a patient interface device including a mask component having a soft, flexible sealing cushion on the face of the patient. The mask component may be, without limitation, a nasal mask that covers the patient's nose, a nasal/oral mask that covers the patient's nose and mouth, or a full face mask that covers the patient's face. Such patient interface devices may also employ other patient contacting components, such as forehead supports, cheek pads and chin pads. The patient interface device is typically secured to the patient's head by a headgear component. The patient interface device is connected to a gas delivery tube or conduit and interfaces the pressure support device with the airway of the patient, so that a flow of breathing gas can be delivered from the pressure/flow generating device to the airway of the patient.

CPAP masks with air delivery tubing integrated into headgear and frames is becoming more commonplace and is seen, for example, without limitation, in masks such as the DreamWear mask manufactured and sold by Philips Respironics, an example of which is shown generally at <NUM> in <FIG>. DreamWear mask <NUM> includes a frame <NUM> having an integrated gas pathway <NUM> (shown in hidden line) that carries the therapy air from an inlet <NUM> which is structured to be positioned at the top of a user's head (not shown) to a nasal interface <NUM> which is structured to sealing engage about the nares of the user. Mask <NUM> further includes an adjustable headgear <NUM> for assisting in securing frame <NUM> to the head of a user.

While headgear <NUM> provides some adjustability for sizing, for most sizing the total overall perimeter of frame <NUM> is changed to affect patient fit and is done so by replacing the entire frame <NUM> with a different size frame. However, as frame <NUM> is quite a large part on mask <NUM>, there are three notable disadvantages to such arrangement: i) DME's (Durable Medical Equipment) find such arrangement economically burdensome due to space and cost to stock; ii) RT's (Respiratory Therapists) find the ease of use to change the size (disassemble headgear, elbow, mask and switch the frame) cumbersome; and iii) manufacturing of such large continuous pieces is difficult and generally requires a high number of injection molding presses.

The first two of these issues may result in patients not receiving the proper size frame <NUM>. Having a simpler way to adjust the frame allows one to improve ease of use, reduce the amount of space needed to store a sufficient quantity of the product, and would reduce the cost burden. Resolving such problems with masks of this type could greatly increase the use of the product by the DME, RT and consequently the patient.

<CIT> discloses an inflatable positioning and stabilizing structure for a patient interface.

<CIT> discloses a respiratory mask for continuous positive airway pressure treatment including a cushion adapted to be positioned against the face of a patient.

Accordingly, it is an object of the present invention to provide a system that overcomes the shortcomings of conventional interface devices used in delivering a flow of a treatment gas to the airway of a patient.

As one aspect of the invention, a frame for use in an interface device having a sealing assembly for delivering a flow of treatment gas to the airway of a patient is provided according to claim <NUM>.

The first end of the first frame member and the first end of the second frame member may be merged together in a single inlet conduit which is structured to be coupled to the conduit supplying the flow of treatment gas.

As another aspect of the present invention, an interface device for use in delivering a flow of treatment gas to the airway of a user of the device is provided according to claim <NUM>.

As another aspect of the present invention, a system for use in delivering a flow of a breathing gas to the airway of a patient is provided according to claim <NUM>.

It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention as defined by the claims.

As used herein, the singular form of "a", "an", and "the" include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are "coupled" shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, "directly coupled" means that two elements are directly in contact with each other. As used herein, "fixedly coupled" or "fixed" means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other. As used herein, "selectively coupled" means that two components are coupled in a manner which allows for the components to be readily coupled or uncoupled in a predictable, repeatable manner without damaging either of the components. Unless particularly described otherwise herein, any components which are described merely as being "coupled", may also be "fixedly" or "selectively" coupled without varying from the scope of the present invention.

As used herein, the word "unitary" means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a "unitary" component or body. As used herein, the statement that two or more parts or components "engage" one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components. As used herein, the term "number" shall mean one or an integer greater than one (i.e., a plurality).

An example airway pressure support system <NUM> according to one particular, non-limiting exemplary embodiment of the present invention is shown in <FIG>. System <NUM> includes a pressure/flow generator <NUM>, a delivery conduit <NUM>, and patient interface device <NUM> disposed on the head (not numbered) of a patient. Pressure/flow generator <NUM> is structured to generate a flow of breathing gas which may be heated and/or humidified. Pressure/flow generator <NUM> may include, without limitation, ventilators, constant pressure support devices (such as a continuous positive airway pressure device, or CPAP device), variable pressure devices (e.g., BiPAP®, Bi-Flex®, or C-Flex™ devices manufactured and distributed by Philips Respironics of Murrysville, Pennsylvania), and auto-titration pressure support devices. Delivery conduit <NUM> is structured to communicate the flow of breathing gas from pressure/flow generator <NUM> to patient interface device <NUM>. Delivery conduit <NUM> and patient interface device <NUM> are often collectively referred to as a patient circuit.

A BiPAP® device is a bi-level device in which the pressure provided to the patient varies with the patient's respiratory cycle, so that a higher pressure is delivered during inspiration than during expiration. An auto-titration pressure support system is a system in which the pressure varies with the condition of the patient, such as whether the patient is snoring or experiencing an apnea or hypopnea. For present purposes, pressure/flow generating device <NUM> is also referred to as either pressure generating device or gas flow generating device, because flow results when a pressure gradient is generated. The present invention contemplates that pressure/flow generating device <NUM> is any conventional system for delivering a flow of gas to an airway of a patient or for elevating a pressure of gas at an airway of the patient, including the pressure support systems summarized above and non-invasive ventilation systems. Although described herein in example embodiments wherein a pressurized flow of gas is utilized, it is to be appreciated that embodiments of the invention as described herein could also be readily employed in other generally non-pressurized applications (e.g., without limitation, in high flow therapy applications).

In the exemplary embodiment of <FIG>, patient interface device <NUM> includes a patient sealing assembly <NUM> coupled to an example adjustable frame <NUM> according to one example embodiment of the present invention. In the example embodiment illustrated in <FIG> and <FIG>, patient sealing assembly <NUM> is a nasal pillow, however, it is to be appreciated that other types of patient sealing assemblies, such as, without limitation, a nasal/oral mask, a nasal cushion, or any other suitable arrangements which facilitate the delivery of the flow of breathing gas to the airway of a patient may be substituted for patient sealing assembly <NUM> while remaining within the scope of the present invention.

Continuing to refer to <FIG> and <FIG>, frame <NUM> includes a first frame member <NUM> having a first end 42a which is structured to be coupled to a conduit (e.g., delivery conduit <NUM>) supplying the flow of treatment gas and an opposite second end 42b coupled to sealing assembly <NUM>. First frame member <NUM> includes a flow passage (not numbered) defined therein which extends between first end 42a and second end 42b which is structured to convey a flow of treatment gas (such as provided by pressure/flow generator <NUM>) through first frame member <NUM>. Frame <NUM> further includes a second frame member <NUM> of similar arrangement as first frame member <NUM>. Accordingly, second frame member <NUM> has a first end 52a structured to be coupled to a conduit supplying the flow of treatment gas and an opposite second end 52b coupled to sealing assembly <NUM>. Second frame member <NUM> also includes a passage (not numbered) defined therein which extends between first end 52a second end 52b which is structured to convey a flow of treatment gas (such as provided by pressure/flow generator <NUM>) through second frame member <NUM>. First frame member <NUM> and second frame member <NUM> are coupled together at or near first ends 42a and 52a thereof via any suitable coupling mechanism. In the example embodiment of the present concept illustrated in <FIG> and <FIG>, first end 42a of first frame member <NUM> and first end 52a of second frame member <NUM> are merged together in a single inlet conduit <NUM> which is structured to be coupled to a conduit, such as conduit <NUM>, supplying a flow of treatment gas.

Frame <NUM> is constructed such that when positioned on the head of a patient (e.g., such as shown in <FIG> and <FIG>) first frame member <NUM> and second frame member <NUM> are biased toward each other. For example, as shown in <FIG>, when frame <NUM> is disposed on the head of a patient, first frame member <NUM> is disposed on a first side of, and biased generally toward, a reference plane P which generally bisects the face and head of the patient and passes through sealing assembly <NUM> and second frame member <NUM> is disposed on a second side of, and biased toward, reference plane P opposite the first side.

In one example embodiment, such biasing is accomplished by forming first and second frame members <NUM> and <NUM> from a flexibly resilient material in a first positioning narrower than the width of a human head. Hence, when flexed to a wider second positioning, such as when frame <NUM> is positioned on a human head, first and second frame members <NUM> and <NUM> are distorted from such first positioning and thus are biased toward each other due to the inherent construction of members <NUM> and <NUM>.

According to the invention, frame further includes a strap <NUM> spanning between a first end 60a and an opposite second end 60b. First end 60a is coupled to first frame member <NUM> at a location between first end 42a and second end 42b of first frame member <NUM> while second end 60b is coupled to second frame member <NUM> at a location between first end 52a and second end 52b such that strap <NUM> spans between first frame member <NUM> and second frame member <NUM>. Strap <NUM> serves as a mechanism which: i) alone biases first frame member <NUM> and second frame member <NUM>; or ii) which assists in biasing first frame member <NUM> and second frame member <NUM> in addition to another biasing mechanism. Strap <NUM> is formed from an elastic material (e.g., silicone, an elastic textile material, etc.) such that strap <NUM> acts generally as a spring. As shown schematically in <FIG>, strap <NUM> may include one or more adjustment mechanisms <NUM> (e.g., hook and loop or any other suitable arrangement(s)) which allow for selective adjustment of the length L of strap <NUM> and thus the distance between first end 60a and second end 60b of strap <NUM>.

An example embodiment of another patient interface device, not according to the present invention, is shown in <FIG>. Patient interface device <NUM> includes a patient sealing assembly <NUM> coupled to an example adjustable frame <NUM>, not according to the present invention. In the example embodiment illustrated in <FIG>, patient sealing assembly <NUM> is a nasal pillow, however, it is to be appreciated that other types of patient sealing assemblies, such as, without limitation, a nasal/oral mask, a nasal cushion, or any other suitable arrangements which facilitate the delivery of the flow of breathing gas to the airway of a patient may be substituted for patient sealing assembly <NUM>. Patient interface device may also include a suitable headgear <NUM> for assisting in securing patient interface device <NUM> to the head of a patient.

Continuing to refer to <FIG>, frame <NUM> includes a central hub member <NUM>, a first frame member <NUM> and a second frame member <NUM>. Central hub member <NUM> is formed as a generally hollow member and includes a central inlet 76a shown with an example elbow <NUM> coupled thereto, a first outlet 76b (shown in hidden line) and a second outlet 76c (shown in hidden line). First outlet 76a and second outlet 76b are disposed generally at opposite ends of central hub member <NUM> while central inlet 76a is disposed generally in a mid-portion of central hub member <NUM> between first outlet 76b and second outlet 76c. In use, elbow <NUM> is coupled to a suitable conduit (such as conduit <NUM> of <FIG>) for receiving a flow of treatment gas therefrom. The flow of treatment gas is then communicated to the interior of central hub member via central inlet 76a and exits therefrom via either of first outlet 76b or second outlet 76c.

First frame member <NUM> includes a first end 78a, which is selectively coupled to first outlet 76b of central hub member <NUM>, and an opposite second end 78b which is coupled to sealing assembly <NUM>. First frame member <NUM> includes a flow passage (not numbered) defined therein which extends between first end 78a and second end 78b which is structured to convey a flow of treatment gas (such as provided by pressure/flow generator <NUM> of <FIG>) received from central hub member <NUM> through first frame member <NUM>. Second frame member <NUM> is of similar arrangement as first frame member <NUM>. Accordingly, second frame member <NUM> has a first end 80a selectively coupled to second outlet 76b of central hub member <NUM>, and an opposite second end 80b coupled to sealing assembly <NUM>. Second frame member <NUM> also includes a passage (not numbered) defined therein which extends between first end 80a and second end 80b which is structured to convey a flow of treatment gas (such as provided by pressure/flow generator <NUM> of <FIG>) received from central hub member <NUM> through second frame member <NUM>.

Frame <NUM> may be selectively sized to a particular patient by replacing central hub member <NUM> (i.e., by selectively uncoupling from first frame member <NUM> and second frame member <NUM>) with another central hub member of different size. <FIG> shows examples of three central hub members <NUM>, <NUM>' and <NUM>" of different width W, W' and W" which may be employed in frame <NUM> of patient interface device <NUM> in sizing for a particular patient. Such variety of different sized hub members <NUM>, <NUM>' and <NUM>" may be provided in a kit with patient interface device <NUM> or as a fitting kit provided separately from patient interface device <NUM>. Although only three central hub members of differing width are shown, it is to be appreciated that one or both of the quantity and varied dimension of dimensions of central hub members may be varied.

<FIG> show examples of further central hub members <NUM> and <NUM>' that may be employed to provide for selective sizing of patient interface device <NUM> of <FIG> to the head of a patient. Like central hub member <NUM>, previously discussed, each of central hub members <NUM> and <NUM>' is formed as a generally hollow member including a central a central inlet <NUM>, <NUM>', which is structured to be coupled to a conduit (e.g., via an elbow connector, not shown) providing a supply of a treatment gas, and a pair of opposing outlets 94a and 94b disposed apart a first distance WS which are each structured to be selectively coupled to one of first end 78a of first frame member <NUM> and first end 80a of second frame member <NUM> of patient interface device <NUM> of <FIG>. Unlike central hub member <NUM>, central hub member <NUM> further includes an additional pair of opposing outlets 96a and 96b disposed apart a second distance WL, greater than first distance Ws, which are each structured to be selectively coupled to one of first end 78a of first frame member <NUM> and first end 80a of second frame member of patient interface device <NUM> of <FIG>. From such arrangement central hub member <NUM> provides for two different sizing choices in a single element dependent on which pair of outlets frame members <NUM> and <NUM> are coupled. In order to prevent treatment gas from escaping the unused pair of outlets, each of outlets 94a, 94b, 96a and 96b include a valve mechanism <NUM> (e.g., without limitation, a flapper valve) which is disposed on a closed position, thus preventing treatment gas from passing therethrough, when the associated outlet is not coupled to one of frame members <NUM> or <NUM>. Central hub member <NUM>' of similar to central hub member <NUM> except central hub member <NUM>' includes yet a further pair of opposing outlets 98a' and 98b' disposed apart a third distance WM, which is greater than Ws and less than WL. Hence, central hub member provides for three different sizing possibilities dependent on the pair of outlets which are utilized.

Selected portions of another example adjustable frame <NUM> which may be employed in a patient interface similar to patient interface device <NUM> of <FIG> are illustrated in <FIG>. More particularly, frame <NUM> includes a generally hollow central hub member <NUM>, which is also shown alone in <FIG>, and a pair of generally hollow arm members <NUM>, <NUM> (only a left side, relative to the patient, arm member <NUM> is shown in the partial assembly of <FIG> and a right side, relative to the patient, arm member <NUM> is shown alone in <FIG>). Referring to <FIG>, central hub member <NUM> includes an inlet 101a and a pair of opposing outlets 101b and 101c. Inlet 101a is structured to be coupled to a conduit (e.g., via an elbow connector) for receiving a flow of treatment gas. Each of outlets 101b and 101c are disposed at the end of reduced portions 104a and 104b of central hub member <NUM> which extend generally outward from inlet <NUM>. Each reduced portion 104a, 104b is structured to be coupled to a corresponding first end 102a, 103a of a respective arm member <NUM>, <NUM> such that treatment gas received at inlet 101a of central hub member <NUM> is communicated to each arm member <NUM>, <NUM> and communicated therethrough to a second end 102b, 103b thereof and then to a sealing assembly (not shown), such as previously discussed, which may be coupled to second end 102b, 103b.

As demonstrated in the transition from <FIG>, the coupling between each reduced portion 104a and 104b of central hub member <NUM> and each arm member <NUM> and <NUM> is a generally telescoping-type slidable coupling which provides for a distance D between portions of central hub member <NUM> and each frame member <NUM>, <NUM> to be selectively varied, thus generally providing for the size of frame <NUM> to be selectively varied. Tactile interlocks (not numbered) of any suitable arrangement may be provided between each reduced portion 104a, 104b and one or both of central hub member <NUM> and each arm member <NUM>, <NUM> which provide for selective locking of each arm member <NUM>, <NUM> and central hub member <NUM> in predetermined particular locations corresponding to predetermined sizes. Although shown as extensions of central hub member <NUM> in the example embodiment described in conjunction with <FIG>, it is to be appreciated that reduced portions 104a and 104b may be alternatively be formed as extensions of arm members <NUM> which slidingly engage into correspondingly sized outlets of a central hub member or as independent elements separate from each of a central hub member and arm members.

As shown in <FIG>, each of reduced portions 104a and 104b may include a directional stiffener <NUM>, <NUM> which is structured to generally increase stiffness (i.e., rigidity) of each reduced portion in one or more predetermined directions, while generally not increasing stiffness in one or more predetermined directions. Each stiffener <NUM>, <NUM> may be formed: i) integrally with each reduced portion 104a, 104b; or ii) as a separate element which is then coupled (via mechanical or chemical means) to each reduced portion 104a, 104b. In the example illustrated in <FIG>, stiffener <NUM> (and <NUM>) is formed from a plastic of greater stiffness than reduced portion 104b which is forcibly slid onto reduced portion 104b. Each of reduced portions 104a and 104b and/or stiffeners <NUM> and <NUM> may include outward extending sealing bands <NUM> which extend around at a least a portion of the periphery of each reduced portion 104a, 104b and which are sized and structured to sealingly engage with an inside surface (not numbered) of a respective arm member <NUM>, <NUM> in a manner which prevents gas leakage at the junctions between central hub member <NUM> and arm members <NUM> and <NUM>.

As also shown in <FIG>, each of reduced portions 104a and 104b and/or stiffeners <NUM> and <NUM> may include one or more outward extending locking tabs <NUM> which are each structured to engage a portion of each arm member <NUM>, <NUM> in a manner which generally prohibits each arm member <NUM>, <NUM> from being inadvertently slid completely off of the corresponding reduced portion 104a, 104b. In the example illustrated in <FIG>, each arm member <NUM>, <NUM> includes a C-shaped rigid clip <NUM> which, as shown in <FIG>, is overmolded to arm member <NUM> (and similarly to arm member <NUM>). As shown in the simplified sectional view of <FIG>, rigid clip <NUM> is positioned within arm member <NUM> so as to be engaged by locking tab <NUM> of reduced portion 104a in a manner which prohibits arm member <NUM> from disengaging with reduced portion 104a.

Another example patient interface <NUM>, not according to the present invention, is shown in <FIG>. Patient interface device <NUM> includes a patient sealing assembly <NUM> coupled to an example adjustable frame <NUM>, not according to the present invention. In the example embodiment illustrated in <FIG>, patient sealing assembly <NUM> is a nasal pillow, however, it is to be appreciated that other types of patient sealing assemblies, such as, without limitation, a nasal/oral mask, a nasal cushion, or any other suitable arrangements which facilitate the delivery of the flow of breathing gas to the airway of a patient may be substituted for patient sealing assembly <NUM>.

Continuing to refer to <FIG>, frame <NUM> includes a first frame member <NUM> having a first end 126a which is structured to be coupled to a conduit (e.g., delivery conduit <NUM> of <FIG>), such as via a suitable connector <NUM>, supplying the flow of treatment gas and an opposite second end 126b coupled to sealing assembly <NUM>. First frame member <NUM> includes a flow passage (not numbered) defined therein which extends between first end 126a and second end 126b which is structured to convey a flow of treatment gas (such as provided by pressure/flow generator <NUM> of <FIG>) through first frame member <NUM>. Frame <NUM> further includes a second frame member <NUM> of similar arrangement as first frame member <NUM>. Accordingly, second frame member <NUM> has a first end 128a structured to be coupled to first end 126a od first frame member <NUM> and an opposite second end 128b coupled to sealing assembly <NUM>. Second frame member <NUM> also includes a passage (not numbered) defined therein which extends between first end 128a and second end 128b which is structured to convey a flow of treatment gas (such as provided by pressure/flow generator <NUM> of <FIG>) through second frame member <NUM>. First frame member <NUM> and second frame member <NUM> are coupled together at or near first ends 126a and 128a thereof such that first ends 126A and 128A overlap. Example arrangements of such coupling between first ends 126A and 128A are shown respectively in <FIG> and <FIG>.

Referring first to <FIG>, an example arrangement in which first ends 126A and 128A are adjustably coupled is shown. More particularly, first frame member <NUM> includes an elongated slot <NUM> defined therein at or about first end 126A. In the example embodiment illustrated in <FIG>, frame member <NUM> further includes a seal member <NUM> which encircles slot <NUM>. Second frame member <NUM> includes a hollow protrusion <NUM> which extends from second frame member at or about first end 128A thereof. Hollow protrusion <NUM> is sized and configured to be slidingly engaged with slot <NUM> in a snap-fit manner such that first frame member and second frame member are coupled at or about first end 126A and first end 128A in a manner such that first frame member <NUM> and second frame member can slide with respect to each other, while remaining coupled. Furthermore, first frame member <NUM> and second frame member <NUM> are sealingly engaged (e.g., by seal member <NUM>) when hollow protrusion <NUM> is positioned in any position within slot <NUM> such that a flow of a treatment gas provided to first frame member <NUM> (e.g., via connector <NUM>) passes partly into second frame member <NUM> (and partly along first frame member <NUM>) via hollow protrusion <NUM>, and then further along second frame member <NUM> to second end 128b thereof. Hence, it is to be appreciated that such arrangement generally provides for the size of frame <NUM> to be selectively varied.

Referring now to <FIG>, another example arrangement in which first ends 126A and 128A of patient interface device <NUM> of <FIG>, denoted as 126A' and 128A' in <FIG>, are adjustably coupled is shown. More particularly, in such example embodiment first frame member <NUM>' includes a hollow protrusion <NUM> which extends from first frame member <NUM>' at or about first end 126A' thereof and a number of first magnetic elements <NUM> (two are shown) coupled to first frame member <NUM>' generally at or about hollow protrusion <NUM>. Second frame member <NUM>' includes a plurality of inlet openings <NUM> (three are shown) disposed at or about first end 128A' thereof which are each sized and configured to be engaged by hollow protrusion <NUM>, such that hollow protrusion <NUM> can be selectively disposed in any one opening of inlet openings <NUM>. Second frame member <NUM>' further includes a number of second magnetic elements <NUM> which are positioned and structured to magnetically interact in an attractive manner with one or more of the number of first magnetic elements <NUM> of first frame member <NUM>' when hollow protrusion <NUM> is disposed any one opening of inlet openings <NUM> such that first end 126a' of first frame member <NUM>' and first end 128a' of second frame member <NUM>' are coupled together. When hollow protrusion <NUM> is disposed in any one of inlet openings <NUM>, a flow of a treatment gas provided to first frame member <NUM>' (e.g., via connector <NUM>) passes partly into second frame member <NUM>' (and partly along first frame member <NUM>') via hollow protrusion <NUM>, and then further along second frame member <NUM>' to an opposite second end (not numbered) thereof. Each of inlet openings <NUM> is provided with a valve mechanism <NUM> (e.g., without limitation, a number of flapper valves) in order to prevent the escape of treatment gas through one or more inlet openings <NUM> in which hollow protrusion <NUM> is not engaged. Hence, it is to be appreciated that the arrangement illustrated in <FIG> generally provides for the size of frame <NUM>' to be selectively varied in an incremental manner (as determined by the quantity of inlet openings <NUM>).

Yet another example patient interface <NUM>, not according to the present invention, is shown in <FIG>. Patient interface device <NUM> includes a patient sealing assembly <NUM> coupled to an example adjustable frame <NUM>, not according to the present invention. In the example embodiment illustrated in <FIG>, patient sealing assembly <NUM> is a nasal pillow, however, it is to be appreciated that other types of patient sealing assemblies, such as, without limitation, a nasal/oral mask, a nasal cushion, or any other suitable arrangements which facilitate the delivery of the flow of breathing gas to the airway of a patient may be substituted for patient sealing assembly <NUM>.

Continuing to refer to <FIG>, frame <NUM> is formed from a flexible material (e.g., silicone) as a single element having a central opening <NUM> and a pair of arms <NUM>, <NUM> which extend generally therefrom and terminate at respective ends <NUM>, <NUM> which are coupled to sealing assembly <NUM>. Frame <NUM> is formed as a generally hollow tubular member such that a flow of treatment gas provided to central opening <NUM> is conveyed to each of ends <NUM>, <NUM> to sealing assembly <NUM> and finally to an airway of the patient engaged with sealing assembly <NUM>. Central opening <NUM> is defined within a portion of frame <NUM> that is generally more flexible than the remainder of frame <NUM>. Such extra flexibility may be accomplished via a thinner region, a region having a lower durometer, or any other suitable means. Such flexibility is utilized to house a generally hollow hub member, such as any of hub members <NUM>, <NUM> or <NUM> of <FIG>, <FIG> and <FIG> which provide for adjusting frame <NUM> in fitting patient interface device <NUM> to the head of a patient. In example embodiments, hub members <NUM>, <NUM>, <NUM> have been formed from a semi-rigid, yet flexible material, although other materials may be employed.

Referring to FIGS. <NUM>, <NUM>, and <NUM>, each of hub members <NUM>, <NUM> and <NUM> include: a main body <NUM>, <NUM>, <NUM>, having a central inlet <NUM>, <NUM>, <NUM> which is structured to be coupled to a conduit (e.g., conduit <NUM> of <FIG>) providing a flow of a treatment gas; a first outlet <NUM>, <NUM>, <NUM> which is positioned to supply first arm <NUM> of patient interface device <NUM> with a portion of a supply of treatment gas received at inlet <NUM>, <NUM>, <NUM>; and a second outlet <NUM>, <NUM>, <NUM> which is positioned to supply second arm <NUM> of patient interface device <NUM> with a portion of a supply of treatment gas received at inlet <NUM>, <NUM>, <NUM>.

Referring to <FIG>, frame <NUM> of patient interface device <NUM> is shown in a "relaxed" first positioning about hub <NUM> such that central inlet <NUM> of hub <NUM> is accessible via central opening <NUM> of frame <NUM>. In such example embodiment frame <NUM> includes a number (four are shown) of inward extending protrusions <NUM> which are positioned on the interior of frame <NUM>. Referring now to <FIG>, frame <NUM> of patient interface device <NUM> is shown in a "stretched" second positioning about hub <NUM> such that central inlet <NUM> of hub <NUM> is accessible via central opening <NUM> of frame <NUM>. In such example positioning, frame <NUM> has been stretched (i.e., elongated a predetermined amount) such that inward extending protrusions thereof are engaged with hub <NUM> about each of outlets <NUM> and <NUM>. It is thus to be readily appreciated that such hub and deformable frame arrangement thus provides for two different sizings of frame <NUM> to be provided without changing any parts.

<FIG> and <FIG> show hub/frame arrangements which operate in a similar manner as that of <FIG>. Referring to <FIG>, frame <NUM> of patient interface device <NUM> is shown in a "relaxed" first positioning about hub <NUM> such that central inlet <NUM> of hub <NUM> is accessible via central opening <NUM> of frame <NUM>. In such example embodiment frame <NUM> includes a number (four are shown) of notches <NUM> defined in the interior surface of frame <NUM> which are engageable by a number (four are shown) of protrusions <NUM> which extend outward from main body <NUM> of hub <NUM>. Referring now to <FIG>, frame <NUM> of patient interface device <NUM> is shown in a "stretched" second positioning about hub <NUM> such that central inlet <NUM> of hub <NUM> is accessible via central opening <NUM> of frame <NUM>. In such example positioning, frame <NUM> has been stretched (i.e., elongated a predetermined amount) such that notches <NUM> thereof are engaged by protrusions <NUM> of hub <NUM>.

<FIG> show a hub/frame arrangement similar to that of <FIG> but which offers three different sizing positions. Referring to <FIG>, frame <NUM> of patient interface device <NUM> is shown in a "relaxed" first positioning about hub <NUM> such that central inlet <NUM> of hub <NUM> is accessible via central opening <NUM> of frame <NUM>. In such example embodiment frame <NUM> includes a number (four are shown) of notches <NUM> defined in the interior surface of frame <NUM> which are engageable by a number (eight are shown) of protrusions <NUM> which extend outward from main body <NUM> of hub <NUM>. Protrusions <NUM> are generally positioning in two groupings, an "inner" grouping and an "outer" grouping. Referring now to <FIG>, frame <NUM> of patient interface device <NUM> is shown in a "semi-stretched" second positioning about hub <NUM> such that central inlet <NUM> of hub <NUM> is accessible via central opening <NUM> of frame <NUM>. In such example positioning, frame <NUM> has been stretched a relatively small amount (i.e., elongated a predetermined first amount) such that notches <NUM> thereof are engaged by "inner" protrusions <NUM> of hub <NUM>. Referring finally to <FIG>, frame <NUM> of patient interface device <NUM> is shown in a "frilly stretched" third positioning about hub <NUM> such that central inlet <NUM> of hub <NUM> is accessible via central opening <NUM> of frame <NUM>. In such example positioning, frame <NUM> has been stretched a larger amount (i.e., elongated a predetermined second amount) such that notches <NUM> thereof are engaged by "outer" protrusions <NUM> of hub <NUM>.

Claim 1:
A frame (<NUM>) for use in an interface device (<NUM>) having a sealing assembly (<NUM>) for delivering a flow of treatment gas to the airway of a patient, the frame comprising:
a first frame member (<NUM>) having a first end (42a) structured to be coupled to a conduit (<NUM>) supplying the flow of treatment gas and an opposite second end (42b) structured to be coupled to the sealing assembly, the first frame member having a passage defined therein which extends between the first end and the second end thereof;
a second frame member (<NUM>) having a first end (52a) structured to be coupled to the conduit supplying the flow of treatment gas and an opposite second (52b) end structured to be coupled to the sealing assembly, the second frame member having a passage defined therein which extends between the first end and the second end thereof; and
a strap (<NUM>) coupled between the first frame member and the second frame member, wherein the strap (<NUM>) comprises a first end (60a) and an opposite second end (60b), wherein the first end of the strap is coupled to the first frame member at a location between the first end and the second end of the first frame member, and wherein the second end of the strap is coupled to the second frame member at a location between the first end and the second end of the second frame member;
wherein the first frame member is disposed on a first side of a reference plane (P) which passes through the sealing assembly and the second frame member is disposed on a second side of the reference plane opposite the first side, and
characterized in that the strap serves to bias at least one of the first frame member and the second frame member toward the other of the first frame member and the second frame member, and the strap is formed from an elastic material such that the strap acts like a spring.