Patent Description:
During medical treatments, it may be sometimes desirable to deliver a flow of breathing gas non-invasively to an airway of a patient, i.e., without intubating the patient or surgically inserting a tracheal tube in their esophagus. For example, it is known to ventilate a patient using a technique known as non-invasive ventilation. It is also known to deliver continuous positive airway pressure (CPAP) or variable airway pressure, which varies with patient's respiratory cycle, to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), or congestive heart failure.

Non-invasive ventilation and pressure support therapies may involve the placement of a patient interface device in combination with a tubing assembly on a head of the patient. The patient interface device may comprise, without limitation, a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth, or a full face mask that covers the patient's face. The patient interface device interfaces the ventilator or pressure support device with the airway of the patient, so that a flow of breathing gas can be delivered from a pressure/flow generating device to the airway of the patient.

A number of known tubing assemblies provide airflow to the patient via one or more delivery tubes that wrap around portions of the head of the patient as part of the tubing assembly. The tubing assembly generally comprises a manifold. The manifold is coupled to, and in fluid communication with, a delivery conduit. The delivery conduit is further coupled to, and in fluid communication with, the pressure/flow generating device.

Such known patient interface devices, however, have a number of drawbacks. For example, due to the functionality of the tubing assembly in providing the airflow to the patient, sizing options of such tubing assembly may be typically limited and generally not customizable. In order to fit different head sizes, options of different frame sizes exist. In some cases, such multiple frame sizes may be accomplished through individual parts. The individual parts may pose multiple challenges in ensuring that the patient receives an appropriate frame size. In some cases, the individual parts may have to be assembled/disassembled by the patient or a caregiver prior to use to adjust the tubing assembly according to a patient's requirement. Such an approach may be confusing for the patient and may affect ease of use. Further, the individual parts of the tubing assemblies may increase inventory, part numbers, and a cost of the tubing assembly. In some cases, some of the individual parts may get misplaced. In some other cases, as the multiple frame sizes are accomplished through the individual parts, the tubing assembly may be bulky to handle and wear. Thus, such tubing assemblies may not be easy to use and may not be easily adjusted by the patients or care givers according to patient requirements. <CIT> discloses an inflatable positioning and stabilizing structure for a patient interface for delivery of a flow of pressurized air to an entrance of a patient's airways. <CIT> discloses a frame for use in an interface device for delivering a flow of treatment gas to the airway of a patient. <CIT> discloses systems, devices, and methods for treatment of respiratory disease or sleep disordered breathing. <CIT>, which is novelty-only prior art pursuant to Article <NUM>(<NUM>) EPC, discloses a positioning and stabilizing structure comprising a gas delivery tube to receive a flow of air from a connection port on top of the patients head and to deliver the flow of air to the entrance of the patients airways.

The invention is defined in the appended independent claim <NUM>. Preferred embodiments are matter of the dependent claims.

Accordingly, a first aspect of the present invention relates to a tubing assembly for use with a patient interface device in delivering a flow of breathing gas to an airway of a user. The tubing assembly comprises a manifold portion structured to be disposed generally atop the user's head and adapted to be coupled to a conduit carrying the flow of breathing gas. The tubing assembly also comprises a plurality of tubular portions. Each tubular portion extends from the manifold portion to a distal end which is structured to be coupled to the patient interface device. Each tubular portion is structured to communicate the flow of breathing gas from the manifold portion to the patient interface device. The tubing assembly further comprises at least one adjustment unit configured to adjust a length of a corresponding tubular portion from the plurality of tubular portions. The at least one adjustment unit comprises a first adjustment member integral with or fixedly connected to the corresponding tubular portion and a second adjustment member integral with or fixedly connected to the corresponding tubular portion. The first adjustment member and the second adjustment member are movable relative to each other. The first adjustment member and the second adjustment member are selectively and releasably locked to each other at a selected discrete position from a plurality of discrete positions. The plurality of discrete positions corresponds to a plurality of predetermined lengths of the corresponding tubular portion.

A second aspect of the present invention relates to a respiratory interface system for use in delivering a flow of breathing gas to an airway of a user. The respiratory interface system comprises a patient interface device structured to sealingly engage the airway of the user. The respiratory interface system further comprises the tubing assembly of the first aspect. The distal end of each tubular portion is coupled to the patient interface device.

A third aspect of the present disclosure relates to a method for delivering a flow of breathing gas to an airway of a user (the method not being separately claimed). The method comprises receiving, via a manifold portion, a flow of breathing gas from a conduit. The method also comprises communicating, via a tubular portion, the flow of breathing gas from the manifold portion to a patient interface device that is sealingly engaged with the airway of the user. The method further comprises adjusting, via at least one adjustment unit, a length of the tubular portion. The method further comprises selectively and releasably locking the at least one adjustment unit at a selected discrete position from a plurality of discrete positions. The plurality of discrete positions corresponds to a plurality of predetermined lengths of the tubular portion.

A fourth aspect of the present disclosure relates to a tubing assembly for use with a patient interface device in delivering a flow of breathing gas to an airway of a user. The tubing assembly comprises manifold means for receiving a flow of breathing gas from a conduit. The tubing assembly also comprises tubular means for communicating the flow of breathing gas from the manifold means to the patient interface device that is sealingly engaged with the airway of the user. The tubing assembly further comprises adjustment means for adjusting a length of the tubular means. The tubing assembly further comprises locking means for selectively and releasably locking the adjustment means at a selected discrete position from a plurality of discrete positions. The plurality of discrete positions corresponds to a plurality of predetermined lengths of the tubular means.

A general object of the present invention is to provide a tubing assembly for use with a patient interface device in delivering a flow of breathing gas to an airway of a user that may be adjusted to various discrete positions.

Another object of the present invention is to provide a tubing assembly that can be used by users of different head sizes.

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 scope of the appended claims.

Exemplary embodiments disclosed herein may be more completely understood in consideration of the following detailed description in connection with the following figures.

In the following description, reference is made to the accompanying figures that form a part thereof and in which various embodiments are shown by way of illustration. It is to be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the appended claims. The following detailed description, therefore, is not to be taken in a limiting sense.

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, "fixedly connected" 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, the phrase "sealingly engage" shall mean elements which contact each other in a manner such that a generally air-tight seal is formed therebetween.

As used herein, the term "integral" 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.

<FIG> illustrates a respiratory interface system <NUM> for use in delivering a flow of breathing gas to an airway of a user <NUM>, according to an exemplary embodiment of the present invention. Respiratory interface system <NUM> may be adapted to provide a regimen of respiratory therapy to user <NUM>. Respiratory interface system <NUM> comprises a pressure generating device <NUM> (shown schematically), a conduit <NUM> fluidly coupled to a tubing assembly <NUM>, and a patient interface device <NUM> fluidly coupled to tubing assembly <NUM>. Pressure generating device <NUM> is structured to generate a flow of positive pressure breathing gas and may comprise, 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, Pa. ), and auto-titration pressure support devices. Conduit <NUM> is structured to communicate the flow of breathing gas from pressure generating device <NUM> to patient interface device <NUM> through tubing assembly <NUM>. Specifically, the breathing gas enters at a top of a head <NUM> of user <NUM>. Conduit <NUM>, tubing assembly <NUM>, and patient interface device <NUM> are often collectively referred to as a user circuit.

Further, patient interface device <NUM> is structured to sealingly engage the airway of user <NUM>. Patient interface device <NUM> comprises a patient sealing element <NUM>. In an exemplary embodiment, patient sealing element <NUM> may comprise a nasal cushion made of a soft, flexible material, such as, without limitation, silicone, an appropriately soft thermoplastic elastomer, a closed-cell foam, or any other suitable material or combination of such materials. It is to be appreciated, however, that any type of patient sealing element <NUM>, such as a nasal/oral mask, a nasal pillow, or a full face mask, which may facilitate a delivery of the flow of breathing gas to the airway of user <NUM>, may be used as patient sealing element <NUM> while remaining within the scope of the appended claims. It should be noted that tubing assembly <NUM>, in conjunction with additional attachments, may allow coupling of different types of patient interface devices, without any limitations. <FIG>, <FIG>, and <FIG> show exemplary embodiments of other tubing assemblies <NUM>, <NUM>, <NUM>, respectively, of similar construction as tubing assembly <NUM> except used in conjunction with respective patient interface devices <NUM>, <NUM>, <NUM> having respective patient sealing elements <NUM>, <NUM>, <NUM> in the form of: a full face (under the nose) cushion (<FIG>), a nasal (over the nose) cushion (<FIG>), and individual nasal pillows (<FIG>).

Further, as shown in <FIG>, respiratory interface system <NUM> comprises tubing assembly <NUM> for use with patient interface device <NUM> in delivering the flow of breathing gas to the airway of user <NUM>. Tubing assembly <NUM> may be interchangeably referred to as tubing means <NUM>.

With reference to <FIG> and <FIG>, tubing assembly <NUM> comprises a manifold portion <NUM> structured to be disposed generally atop user's head <NUM> and adapted to be coupled to conduit <NUM> carrying the flow of breathing gas. Manifold portion <NUM> may be interchangeably referred to as manifold means <NUM>. Manifold portion <NUM> is structured to be coupled to conduit <NUM>, such as via an elbow <NUM> or any other suitable coupling member.

Further, tubing assembly <NUM> comprises a plurality of tubular portions <NUM>, <NUM>. Each tubular portion <NUM>, <NUM> extends from manifold portion <NUM> to a distal end <NUM> which is structured to be coupled to patient interface device <NUM>. Distal end <NUM> of each tubular portion <NUM>, <NUM> is coupled to, and is in fluid communication with patient interface device <NUM>.

Each tubular portion <NUM>, <NUM> is structured to communicate the flow of breathing gas from manifold portion <NUM> to patient interface device <NUM>. Further, manifold portion <NUM> provides fluid communication between conduit <NUM> and tubular portions <NUM>, <NUM>. As shown in the accompanying figures, when tubing assembly <NUM> is disposed on head <NUM> of user <NUM>, manifold portion <NUM> is disposed generally at the top of head <NUM> of user <NUM> and tubular portions <NUM>, <NUM> extend generally downward from manifold portion <NUM> to patient sealing element <NUM> of patient interface device <NUM>.

In the illustrated embodiment of <FIG> and <FIG>, tubing assembly <NUM> comprises two tubular portions <NUM>, <NUM>. Each tubular portion <NUM>, <NUM> defines a hollow passage (not shown) for allowing the flow of breathing gas therethrough. Tubular portions <NUM>, <NUM> may be substantially similar in design. In the illustrated embodiment of <FIG> and <FIG>, tubular portions <NUM>, <NUM> are symmetrical to each other with respect to manifold portion <NUM>. Tubular portions <NUM>, <NUM> are disposed at either side of manifold portion <NUM> such that tubular portions <NUM>, <NUM> extend between manifold portion <NUM> and patient interface device <NUM>. In the illustrated embodiment of <FIG> and <FIG>, tubular portions <NUM>, <NUM> have an arcuate shape. In another exemplary embodiment, not shown, tubing assembly <NUM> may comprise a single tubular portion having a pair of arms resembling tubular portions <NUM>, <NUM> that extend centrally, i.e., from manifold portion <NUM> generally over head <NUM> and nose, to patient sealing element <NUM>.

As discussed above, tubular portions <NUM>, <NUM> are embodied as hollow members for allowing the flow of breathing gas to pass therethrough. In various exemplary embodiments, tubular portions <NUM>, <NUM> may have a generally non-circular cross-section, without any limitations. In an exemplary embodiment, tubular portions <NUM>, <NUM> may have a generally D-shaped cross-section. As shown in <FIG>, each tubular portion <NUM>, <NUM> may define a patient facing portion <NUM> that comprises a generally flat side of the D-shape and is disposed adjacent head <NUM> (see <FIG>) of user <NUM> (see <FIG>). Further, a curved portion <NUM> of each tubular portion <NUM>, <NUM> faces away from head <NUM> of user <NUM>. In other exemplary embodiments, tubular portions <NUM>, <NUM> may have any other cross-section. It should be noted that patient facing portion <NUM> may comprise a particular surface texture or may be formed from a separate material that presents a comfortable feel for user <NUM>. Further, tubular portions <NUM>, <NUM> may encircle, or partially encircle, head <NUM> of user <NUM>. Accordingly, it is to be appreciated that tubing assembly <NUM>, as a result of its basic structure and positioning, may not only direct the flow of breathing gas to patient interface device <NUM> (see <FIG>), but also generally functions as a frame that secures patient interface device <NUM> to head <NUM> of user <NUM>.

In an exemplary embodiment, tubing assembly <NUM> may further comprise one or more pad members (not shown) that may be used to vary a feel, or to cushion the tubing assembly <NUM> on head <NUM> of user <NUM> and/or to better fit tubing assembly <NUM> to head <NUM> of user <NUM>. The pad member may be formed from foam, gel, silicone, fabric plastic, or any other suitable material or combination of materials. In various exemplary embodiments, tubing assembly <NUM> may comprise one or more sections of removable cheek wraps (not shown), securable via suitable fasteners such as hook and loop (e.g., Velcro® fasteners), or other fasteners. Cheek wraps may comprise fabric wraps that may be provided to customize a feel of tubing assembly <NUM> to a liking of a particular user.

Further, in order to help secure patient interface device <NUM> and tubing assembly <NUM> to head <NUM> of user <NUM>, tubing assembly <NUM> may comprise a support assembly <NUM>. Support assembly <NUM> may comprise a strap member <NUM> (shown in <FIG>) coupled to tubular portions <NUM>, <NUM> which also encircles, or partially encircles, head <NUM> of user <NUM>. That is, strap member <NUM> may be structured to engage a back of head <NUM> of user <NUM>. In an exemplary embodiment of the present invention, strap member <NUM> may be structured to fit generally just below the occipital bone of user <NUM>. Strap member <NUM> may comprise a design that may allow strap member <NUM> to naturally conform to the back of head <NUM> of user <NUM>. One or more portions of strap member <NUM> may be formed from an elastic fabric (e.g., without limitation, spandex), but may also be formed from other fabrics, silicone, plastics, or any other suitable material or combination of materials such that portions of strap member <NUM> generally exhibits properties of an elastic strap that is typically easy to elongate but has recovery properties. It is to be appreciated that such exemplary materials are provided for example purposes only and that strap member <NUM> may be formed from other materials, without varying from the scope of the appended claims.

Strap member <NUM> may be coupled to each tubular portion <NUM>, <NUM> by a mounting tab <NUM> disposed on each tubular portion <NUM>, <NUM>. Each mounting tab <NUM> may be fixed with respect to each tubular portion <NUM>, <NUM>. In such arrangements, each mounting tab <NUM> may be formed as an integral portion of each tubular portion <NUM>, <NUM>. In another exemplary embodiment, each mounting tab <NUM> may be formed separately therefrom and then rigidly coupled thereto. In other words, each mounting tab <NUM> may be rigidly coupled to a respective tubular portion <NUM>, <NUM>. In exemplary embodiments of the present invention, mounting tab <NUM> may be formed from silicone, however, it is to be appreciated that other suitable materials (e.g., without limitation, plastic, or fabric) may be employed, without varying from the scope of the appended claims.

In some exemplary embodiments, each mounting tab <NUM> may be adjustable with respect to tubing assembly <NUM> so as to allow for each mounting tab <NUM> to be adjusted to provide an optimal fit of tubing assembly <NUM> to head <NUM> of user <NUM>. More particularly, each mounting tab <NUM> may be coupled to respective tubular portion <NUM>, <NUM> in a manner such that each mounting tab <NUM> can generally slide along a portion of respective tubular portion <NUM>, <NUM>. In another exemplary embodiment, support assembly <NUM> may comprise a number of mounting tabs <NUM> placed along respective tubular portion <NUM>, <NUM> to which strap member <NUM> may be selectively coupled by any suitable arrangement to adjust the placement of strap member <NUM>. Alternatively, support assembly <NUM> may omit mounting tabs <NUM> such that strap member <NUM> may be generally placed anywhere along each tubular portion <NUM>, <NUM>. It is to be appreciated that support assembly <NUM> is provided for exemplary purposes only and that support assembly <NUM> of other design and/or construction may be employed, without varying from the scope of the appended claims.

Further, tubing assembly <NUM> comprises at least one adjustment unit <NUM>, <NUM> configured to adjust a length of corresponding tubular portion <NUM>, <NUM> from plurality of tubular portions <NUM>, <NUM>. Adjustment unit <NUM>, <NUM> may be interchangeably referred to as adjustment means <NUM>, <NUM>. In the illustrated embodiment of <FIG>, at least one adjustment unit <NUM>, <NUM> comprises a pair of adjustment units <NUM>, <NUM> disposed on opposing sides of manifold portion <NUM>. Specifically, tubing assembly <NUM> comprises a first adjustment unit <NUM> and a second adjustment unit <NUM>. First adjustment unit <NUM> is configured to adjust the length of tubular portion <NUM> and second adjustment unit <NUM> is configured to adjust the length of tubular portion <NUM>. First and second adjustment units <NUM>, <NUM> are similar in design. First and second adjustment units <NUM>, <NUM> are symmetrical to each other with respect to manifold portion <NUM>. In other exemplary embodiments, it may be contemplated that tubing assembly <NUM> may comprise a single adjustment unit or more than two adjustment units. In the illustrated embodiment of <FIG>, first and second adjustment units <NUM>, <NUM> are disposed proximal to manifold portion <NUM>. However, adjustment units <NUM>, <NUM> may be disposed at any other location along the length of corresponding tubular portion <NUM>, <NUM>.

Further, at least one adjustment unit <NUM>, <NUM> comprises a first adjustment member <NUM> integral with or fixedly connected to corresponding tubular portion <NUM>, <NUM> and a second adjustment member <NUM> integral with or fixedly connected to corresponding tubular portion <NUM>, <NUM>. Each adjustment unit <NUM>, <NUM> comprises one first adjustment member <NUM> and one second adjustment member <NUM>. First and second adjustment members <NUM>, <NUM> have a generally curved profile. One of first adjustment member <NUM> and second adjustment member <NUM> is disposed proximal to manifold portion <NUM>, and the other one of first adjustment member <NUM> and second adjustment member <NUM> is disposed distal to manifold portion <NUM>. In the illustrated embodiment of <FIG>, first adjustment member <NUM> is disposed proximal to manifold portion <NUM>, and second adjustment member <NUM> is disposed distal to manifold portion <NUM>. Further, first and second adjustment members <NUM>, <NUM> may have an arcuate shape that conforms with the shape of corresponding tubular portion <NUM>, <NUM>. In the illustrated embodiment of <FIG>, each of first and second adjustment members <NUM>, <NUM> is fixedly connected to corresponding tubular portion <NUM>, <NUM>. Further, first adjustment member <NUM> and second adjustment member <NUM> are movable relative to each other. Second adjustment member <NUM> may be at least partially received within a hollow portion <NUM> (shown in <FIG> and <FIG>) defined by first adjustment member <NUM>. Alternatively, first adjustment member <NUM> and second adjustment member <NUM> may be disposed such that first adjustment member <NUM> may be at least partially received within a hollow portion (not shown) defined by second adjustment member <NUM>, without any limitations.

Referring to <FIG> and <FIG>, in various exemplary embodiments, first and second adjustment members <NUM>, <NUM> may be connected to corresponding tubular portion <NUM>, <NUM> by a press fit, an interference fit, a snap fit, adhesives, and the like. In the illustrated embodiment of <FIG>, first and second adjustment members <NUM>, <NUM> may comprise a first groove <NUM> and a second groove <NUM>, respectively. Further, each tubular portion <NUM>, <NUM> may comprise a first projecting tab <NUM> (see <FIG>) and a second projecting tab <NUM> (see <FIG>). First projecting tab <NUM> may align with first groove <NUM> in first adjustment member <NUM> for receipt of first projecting tab <NUM> within first groove <NUM> by a press fit. Further, second projecting tab <NUM> may align with second groove <NUM> in second adjustment member <NUM> for receipt of second projecting tab <NUM> within second groove <NUM> by a press fit. Alternatively, first and second adjustment members <NUM>, <NUM> may be pivotally connected to corresponding tubular portion <NUM>, <NUM>. In other exemplary embodiments, any one of first and second adjustment members <NUM>, <NUM> may be pivotally connected to corresponding tubular portion <NUM>, <NUM>. It should be noted that means for fixedly connecting first and second adjustment members <NUM>, <NUM> to corresponding tubular portion <NUM>, <NUM> as described herein is exemplary in nature and does not limit the scope of the appended claims.

Referring now to <FIG>, first adjustment member <NUM> and second adjustment member <NUM> are selectively and releasably locked to each other at a selected discrete position from a plurality of discrete positions. The plurality of discrete positions corresponds to a plurality of predetermined lengths of corresponding tubular portion <NUM>, <NUM>. The term "predetermined length" as used herein may refer to a variable length of tubular portions <NUM>, <NUM> defined between manifold portion <NUM> and distal end <NUM>. Specifically, the predetermined length may vary based on movement of first adjustment member <NUM> and second adjustment member <NUM>. In some exemplary embodiments, the predetermined length may be defined as a curved length as tubular portions <NUM>, <NUM> are arcuate in shape.

Further, the plurality of discrete positions may comprise an extended state, a contracted state, and one or more intermediate states between the extended state and the contracted state. In the illustrated embodiment of <FIG>, the plurality of discrete positions comprises three discrete positions. Although the exemplary embodiments described herein comprises three discrete positions, it should be noted that the plurality of discrete positions may comprise two discrete positions, for example, an extended state and a contracted state. In other exemplary embodiments, the plurality of discrete positions may comprise more than three discrete positions, for example, an extended state, a contracted state, and more than one intermediate states between the extended state and the contracted state, without any limitations. The plurality of discrete positions will be explained in detail later in this section.

Adjustment of tubing assembly <NUM> to different predetermined lengths may allow tubing assembly <NUM> to be used on various users having different head sizes. In some examples, each adjustment unit <NUM>, <NUM> may allow the predetermined length of respective tubular portions <NUM>, <NUM> to increase or decrease by a value between <NUM> and <NUM>. In some examples, each adjustment unit <NUM>, <NUM> may allow the predetermined length of respective tubular portions <NUM>, <NUM> to increase or decrease by a value between <NUM> and <NUM>. In one example, the predetermined length of each tubular portion <NUM>, <NUM> may decrease by a value between <NUM> and <NUM> when tubing assembly <NUM> is switched from the extended state to the intermediate state. Similarly, the predetermined length of each tubular portion <NUM>, <NUM> may increase by a value between <NUM> and <NUM> when tubing assembly <NUM> is switched from the intermediate state to the extended state. In one example, the predetermined length of each tubular portion <NUM>, <NUM> may decrease by a value between <NUM> and <NUM> when tubing assembly <NUM> is switched from the extended state to the intermediate state. Similarly, the predetermined length of each tubular portion <NUM>, <NUM> may increase by a value between <NUM> and <NUM> when tubing assembly <NUM> is switched from the intermediate state to the extended state.

In one example, the predetermined length of each tubular portion <NUM>, <NUM> may decrease by a value between <NUM> and <NUM> when tubing assembly <NUM> is switched from the intermediate state to the contracted state. Similarly, the predetermined length of each tubular portion <NUM>, <NUM> may increase by a value between <NUM> and <NUM> when tubing assembly <NUM> is switched from the contracted state to the intermediate state. In one example, the predetermined length of each tubular portion <NUM>, <NUM> may decrease by a value between <NUM> and <NUM> when tubing assembly <NUM> is switched from the intermediate state to the contracted state. Similarly, the predetermined length of each tubular portion <NUM>, <NUM> may increase by a value between <NUM> and <NUM> when tubing assembly <NUM> is switched from the contracted state to the intermediate state.

Tubing assembly <NUM> further comprises a locking means <NUM> for selectively and releasably locking adjustment unit <NUM>, <NUM> at a selected discrete position from the plurality of discrete positions. Locking means <NUM> may comprise a pin <NUM> and a plurality of through apertures <NUM>, <NUM>, <NUM>. It should be noted that locking means <NUM> described herein exemplary in nature and locking means <NUM> may comprise any other design or combination of components that together allow selective and releasable locking of adjustment units <NUM>, <NUM> at the selected discrete position.

Specifically, first adjustment member <NUM> comprises plurality of through apertures <NUM>, <NUM>, <NUM> corresponding to the plurality of discrete positions. In the illustrated embodiment of <FIG>, first adjustment member <NUM> comprises three through apertures <NUM>, <NUM>, <NUM> corresponding to the three discrete positions. Through apertures <NUM>, <NUM>, <NUM> are equidistantly spaced apart from each other. Alternatively, first adjustment member <NUM> may comprise more than three through apertures <NUM>, <NUM>, <NUM> or less than three through apertures <NUM>, <NUM>, <NUM> based on a total number of discrete positions. Through apertures <NUM>, <NUM>, <NUM> have a substantially rectangular shape. Alternatively, through apertures <NUM>, <NUM>, <NUM> may have a square shape, a circular shape, an oval shape, a polygonal shape, and the like.

Further, second adjustment member <NUM> comprises pin <NUM> selectively, removably, and at least partially received within a selected through aperture <NUM>, <NUM>, <NUM> from plurality of through apertures <NUM>, <NUM>, <NUM> in order to releasably lock second adjustment member <NUM> to first adjustment member <NUM>. In various exemplary embodiments, first adjustment member <NUM> may comprise a number of size indicators (not shown) corresponding to different discrete positions. The size indicators may indicate to user <NUM> regarding the discrete positions of tubing assembly <NUM>. For example, a marking "L" adjacent to through aperture <NUM> may indicate that pin <NUM> should be received within through aperture <NUM> for tubing assembly <NUM> to fit users having a "large" head size. For example, the maximum predetermined length may be suitable for the "large" head size. Further, a marking "M" adjacent to through aperture <NUM> may indicate that pin <NUM> should be received within through aperture <NUM> for tubing assembly <NUM> to fit users having a "medium" head size. For example, the intermediate predetermined length may be suitable for the "medium" head size. Whereas a marking "S" adjacent to through aperture <NUM> may indicate that pin <NUM> should be received within through aperture <NUM> for tubing assembly <NUM> to fit users having a "small" head size. For example, the minimum predetermined length may be suitable for the "small" head size.

Further, a shape of pin <NUM> may be substantially similar to a shape of through apertures <NUM>, <NUM>, <NUM> so that pin <NUM> can be received within through apertures <NUM>, <NUM>, <NUM>. In the illustrated embodiment of <FIG>, pin <NUM> is substantially rectangular in shape. Alternatively, pin <NUM> may comprise any other shape such as a substantially square shape, a substantially circular shape, a substantially oval shape, a substantially polygonal shape, and the like. Pin <NUM> is disposed distal from second groove <NUM> (see <FIG>) of second adjustment member <NUM>. Further, pin <NUM> may be disposed at any other location on second adjustment member <NUM>. Second adjustment member <NUM> may also comprise a biasing portion <NUM> attached to pin <NUM> and configured to resiliently bias pin <NUM> towards plurality of through apertures <NUM>, <NUM>, <NUM>. Biasing portion <NUM> may be movable within a slot <NUM> of second adjustment member <NUM>. Biasing portion <NUM> may bias second adjustment member <NUM> towards plurality of through apertures <NUM>, <NUM>, <NUM> such that pin <NUM> can be received within any one of through apertures <NUM>, <NUM>, <NUM>.

In alternate embodiments, second adjustment member <NUM> may comprise through apertures <NUM>, <NUM>, <NUM>, whereas first adjustment member <NUM> may comprise pin <NUM>, without any limitations. In an exemplary embodiment, through apertures <NUM>, <NUM>, <NUM> may be replaced by recesses (similar to recesses <NUM>, <NUM>, <NUM> shown in <FIG>) or blind apertures. In such an embodiment, first adjustment member <NUM> may comprise lugs (similar to a number of lugs <NUM>, <NUM>, <NUM> shown in <FIG>). In some other exemplary embodiments, first and second adjustment members <NUM>, <NUM> may be releasably locked with each other using any other type of locking. For example, first and second adjustment members <NUM>, <NUM> may be releasably locked with each other by a press fit, a snap fit, adhesives, or other fastening components such as snap fasteners, hook and loop fasteners, and the like, without any limitations.

Further, in various exemplary embodiments of the invention, at least one adjustment unit <NUM>, <NUM> comprises an adjustable section <NUM> integral with corresponding tubular portion <NUM>, <NUM>. A relative movement between first adjustment member <NUM> and second adjustment member <NUM> causes adjustable section <NUM> to elongate or contract. Through such arrangement, the relative spacing between manifold portion <NUM> and patient interface device <NUM> may be adjusted in increments of the predetermined lengths without affecting the flow of breathing gas from corresponding tubular portion <NUM>, <NUM> to patient interface device <NUM>. It is to be appreciated that the predetermined lengths, as well as the general form of adjustable section <NUM> may be varied to meet requirements of a particular application, without varying from the scope of the appended claims.

In various exemplary embodiments, each of first adjustment member <NUM> and second adjustment member <NUM> extends at least partially along a length <NUM> of adjustable section <NUM>. Moreover, second adjustment member <NUM> may be spaced apart from adjustable section <NUM> and at least partially and slidably received within first adjustment member <NUM>. More particularly, a gap <NUM> (shown in <FIG>) may be defined between second adjustment member <NUM> and adjustable section <NUM>. Gap <NUM> may enable second adjustment member <NUM> to freely move without any interference from or engagement with adjustable section <NUM>. In other exemplary embodiments, first adjustment member <NUM> may angularly move relative to second adjustment member <NUM>, for example, when first adjustment member <NUM> is pivotally connected to corresponding tubular portion <NUM>, <NUM>. Further, a portion of adjustable section <NUM> may be slidably received within hollow portion <NUM> defined by first adjustment member <NUM>.

Corresponding tubular portion <NUM>, <NUM> and adjustable section <NUM> may comprise a similar material. In exemplary embodiments, tubular portion <NUM>, <NUM> and adjustable section <NUM> may be made from plastic and/or silicone. Some parts of tubing assembly <NUM> may also be formed from other suitable materials (e.g., without limitation, fabric), without varying from the scope of the appended claims. In some exemplary embodiments, corresponding tubular portion <NUM>, <NUM> and adjustable section <NUM> may be made from different materials. For example, corresponding tubular portion <NUM>, <NUM> and adjustable section <NUM> may be made from materials having different durometer levels. Corresponding tubular portion <NUM>, <NUM> and adjustable section <NUM> may be coupled together via a suitable process, or corresponding tubular portion <NUM>, <NUM> may be integrally formed with adjustable section <NUM>.

Adjustable section <NUM> comprises a first end <NUM> that is proximal to manifold portion <NUM> and a second end <NUM> opposite first end <NUM>. First adjustment member <NUM> may be fixedly connected to corresponding tubular portion <NUM>, <NUM> proximal to first end <NUM> of adjustable section <NUM>. Specifically, first projecting tab <NUM> may be disposed proximal to first end <NUM>. Further, second adjustment member <NUM> may be fixedly connected to corresponding tubular portion <NUM>, <NUM> proximal to second end <NUM> of adjustable section <NUM> opposite to first end <NUM>. Specifically, second projecting tab <NUM> may be disposed proximal to second end <NUM>.

In the illustrated embodiment of <FIG>, adjustable section <NUM> is a corrugated section <NUM> integrally molded with corresponding tubular portion <NUM>, <NUM> and configured to elongate or contract from a normal molded state of corrugated section <NUM>. The normal molded state of corrugated section <NUM> may correspond to one of the extended state, the contracted state, and the one or more intermediate states. Further, first adjustment member <NUM> and second adjustment member <NUM> may be configured to selectively adjust corrugated section <NUM> to the other two of the extended state, the contracted state, and the one or more intermediate states.

Corrugated section <NUM> may comprise a bellows arrangement that elongates or contracts based on movement of corresponding first and second adjustment members <NUM>, <NUM>. Corrugated section <NUM> may comprise a number of corrugations <NUM> that elongates or contracts along length <NUM> of adjustable section <NUM>. In the illustrated embodiment of <FIG>, corrugations <NUM> are spaced apart from each other. Specifically, when first adjustment member <NUM> and second adjustment member <NUM> are moved, spacing between two adjacently disposed corrugations <NUM> may change to allow elongation or contraction of corrugated section <NUM>. In various other exemplary embodiments, corrugated section <NUM> may comprise a continuous helical or spiral design. In the illustrated embodiment of <FIG>, adjustable section <NUM> of each tubular portion <NUM>, <NUM> comprises a single corrugated section <NUM> having corrugations <NUM>. Alternatively, adjustable section <NUM> of each tubular portion <NUM>, <NUM> may comprise multiple corrugated sections (similar to corrugated section <NUM>) that may be spaced apart from each other along length <NUM> of adjustable section <NUM>, such that each of the multiple corrugated sections comprises a number of corrugations, without any limitations.

In the illustrated embodiment of <FIG>, each corrugation <NUM> has a similar shape and size. Further, corrugations <NUM> comprise a generally oval cross-section. Alternatively, corrugations <NUM> may comprise any other shape, such as a rectangular cross-section, a square cross-section, a circular cross-section, a flared cross-section, and the like. In an exemplary embodiment, corrugations <NUM> may be integrally formed with corresponding tubular portion <NUM>, <NUM>. In such embodiments, corrugations <NUM> may be made of a material that is similar to the material of tubular portions <NUM>, <NUM>. In alternate embodiments, corrugations <NUM> may be manufactured separately and subsequently assembled with corresponding tubular portion <NUM>, <NUM>. In such embodiments, corrugations <NUM> may be made of a material that may be different from the material of tubular portions <NUM>, <NUM>. Further, a thickness of each corrugation <NUM> may be chosen such that corrugations <NUM> can endure a manufacturing process and may accommodate realistic variations in tolerances. It should be noted that the present invention is not limited by a number of corrugations <NUM>, the shape of corrugations <NUM>, dimensions of corrugations <NUM>, and the material of corrugations <NUM>.

It should be further noted that a design of adjustable section <NUM> described herein is exemplary in nature, and adjustable section <NUM> may comprise any other design provided that adjustable section <NUM> elongates or contracts based on relative movement between first adjustment member <NUM> and second adjustment member <NUM>. In various exemplary embodiments, adjustable section <NUM> may comprise another design. For example, adjustable section <NUM> may comprise a combination of one or more continuous helical members disposed around a hollow stretchable fibrous material that may allow the flow of breathing gas therethrough, without any limitations.

In various exemplary embodiments, adjustment units <NUM>, <NUM> may comprise any other design or combination of components to dispose adjustment units <NUM>, <NUM> in various discrete positions. For example, adjustment units <NUM>, <NUM> may comprise a single flexible strap or a pair of flexible straps. In various exemplary embodiments, adjustment units <NUM>, <NUM> may comprise a strap and buckle arrangement, or a pair of straps that can be removably connected to each other by techniques such as, hook and loop fasteners (e.g., Velcro® fasteners), snap fasteners, and the like.

In various exemplary embodiments, tubular portions <NUM>, <NUM> may comprise one or more additional flexible sections that are integral with corresponding tubular portion <NUM>, <NUM>. For example, such flexible sections may be present between distal end <NUM> and corresponding adjustment unit <NUM>, <NUM>. The flexible sections may be similar to corrugated section <NUM>, or the flexible sections may comprise any other design, without any limitations.

Various discrete positions associated with tubing assembly <NUM> will now be explained with reference to <FIG>, <FIG>, and <FIG>. <FIG> illustrates first adjustment member <NUM> and second adjustment member <NUM> selectively and releasably locked to each other at the extended state. Specifically, adjustable section <NUM> is in an extended position <NUM>. For explanatory purposes, only tubular portion <NUM> and adjustment unit <NUM> are explained in detail with reference to <FIG>. However, it should be noted that details provided herein are equally applicable to tubular portion <NUM> and adjustment unit <NUM>. Extended position <NUM> may correspond to the maximum predetermined length such that tubing assembly <NUM> is usable by user <NUM> (see <FIG>) having the "large" head size. As illustrated in <FIG>, in extended position <NUM>, adjustable length <NUM> of adjustable section <NUM> corresponds to a maximum length "L1". In extended position <NUM>, pin <NUM> is received within through aperture <NUM>. In one exemplary embodiment, the normal molded state may correspond to extended position <NUM> such that adjustable section <NUM> can contract, for example, up to two sizes, i.e., to an intermediate position <NUM> (shown in <FIG>) and a contracted position <NUM> (shown in <FIG>).

As per application requirements, if adjustable section <NUM> is to be disposed in intermediate position <NUM> or contracted position <NUM>, pin <NUM> may be disengaged from through aperture <NUM>. Further, first and second adjustment members <NUM>, <NUM> are moved towards each other causing corrugated section <NUM> to contract. Moreover, pin <NUM> may be engaged with through apertures <NUM> or <NUM> for disposing adjustable section <NUM> in intermediate position <NUM> or contracted position <NUM>, respectively. It should be noted that when tubing assembly <NUM> switches to intermediate position <NUM> from extended position <NUM>, adjustable length <NUM> may decrease from maximum length "L1" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>. Similarly, when tubing assembly <NUM> switches to contracted position <NUM> from extended position <NUM>, adjustable length <NUM> may decrease from maximum length "L1" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>.

<FIG> illustrates first adjustment member <NUM> and second adjustment member <NUM> selectively and releasably locked to each other at the intermediate state. Specifically, adjustable section <NUM> is in intermediate position <NUM>. For explanatory purposes, only tubular portion <NUM> and adjustment unit <NUM> are explained in detail with reference to <FIG>. However, it should be noted that details provided herein are equally applicable to tubular portion <NUM> and adjustment unit <NUM>. Intermediate position <NUM> may correspond to the intermediate predetermined length, that is smaller than the maximum predetermined length, such that tubing assembly <NUM> is usable by user <NUM> (see <FIG>) having the "medium" head size. As illustrated in <FIG>, in intermediate position <NUM>, adjustable length <NUM> of adjustable section <NUM> corresponds to an intermediate length "L2". In intermediate position <NUM>, pin <NUM> is received within through aperture <NUM>. In one exemplary embodiment, the normal molded state may correspond to intermediate position <NUM> such that adjustable section <NUM> can elongate or contract, for example, by one size from intermediate position <NUM>.

As per application requirements, if adjustable section <NUM> is to be disposed in extended position <NUM> (shown in <FIG>) or contracted position <NUM> (shown in <FIG>), pin <NUM> may be disengaged from through aperture <NUM>. Further, for disposing adjustable section <NUM> in extended position <NUM>, first and second adjustment members <NUM>, <NUM> are moved away from each other causing corrugated section <NUM> to elongate. Moreover, pin <NUM> is engaged with through aperture <NUM> for disposing adjustable section <NUM> in extended position <NUM>. For disposing adjustable section <NUM> in contracted position <NUM>, first and second adjustment members <NUM>, <NUM> are moved towards each other causing corrugated section <NUM> to contract. Moreover, pin <NUM> may be engaged with through aperture <NUM> for disposing adjustable section <NUM> in contracted position <NUM>. It should be noted that when tubing assembly <NUM> switches to extended position <NUM> from intermediate position <NUM>, adjustable length <NUM> may increase from intermediate length "L2" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>. Similarly, when tubing assembly <NUM> switches to contracted position <NUM> from intermediate position <NUM>, adjustable length <NUM> may decrease from intermediate length "L2" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>.

<FIG> illustrates first adjustment member <NUM> and second adjustment member <NUM> selectively and releasably locked to each other at the contracted state. Specifically, adjustable section <NUM> is in contracted position <NUM>. For explanatory purposes, only tubular portion <NUM> and adjustment unit <NUM> are explained in detail with reference to <FIG>. However, it should be noted that details provided herein are equally applicable to tubular portion <NUM> and adjustment unit <NUM>. Contracted position <NUM> may correspond to the minimum predetermined length, that is smaller than the intermediate predetermined length, such that tubing assembly <NUM> is usable by user <NUM> (see <FIG>) having the "small" head size. As illustrated in <FIG>, in contracted position <NUM>, adjustable length <NUM> of adjustable section <NUM> corresponds to a minimum length "L3". In contracted position <NUM>, pin <NUM> is received within through aperture <NUM>. In one exemplary embodiment, the normal molded state may correspond to contracted position <NUM> such that adjustable section <NUM> can elongate, for example, up to two sizes, i.e., to intermediate position <NUM> (shown in <FIG>) and extended position <NUM> (shown in <FIG>).

As per application requirements, if adjustable section <NUM> is to be disposed in intermediate position <NUM> or extended position <NUM>, pin <NUM> is disengaged from through aperture <NUM>. Further, first and second adjustment members <NUM>, <NUM> are moved away from each other causing corrugated section <NUM> to elongate. Moreover, pin <NUM> may be engaged with through apertures <NUM> or <NUM> for disposing adjustable section <NUM> in extended position <NUM> or intermediate position <NUM>, respectively. It should be noted that when tubing assembly <NUM> switches to intermediate position <NUM> from contracted position <NUM>, adjustable length <NUM> may increase from minimum length "L3" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>. Similarly, when tubing assembly <NUM> switches to extended position <NUM> from contracted position <NUM>, adjustable length <NUM> may increase from minimum length "L3" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>.

Referring to <FIG>, in an example, a difference between maximum length "L1" and intermediate length "L2" is between <NUM> and <NUM>. In another example, the difference between maximum length "L1" and intermediate length "L2" is between <NUM> and <NUM>. In an example, a difference between intermediate length "L2" and minimum length "L3" is between <NUM> and <NUM>. In another example, the difference between intermediate length "L2" and minimum length "L3" is between <NUM> and <NUM>. In an example, a difference between maximum length "L1" and minimum length "L3" is between <NUM> and <NUM>. In an example, the difference between maximum length "L1" and minimum length "L3" is between <NUM> and <NUM>. Since each tubular portion <NUM>, <NUM> includes respective adjustable unit <NUM>, <NUM>, an overall length of tubing assembly <NUM> can be adjusted by a total adjustment length that is about twice a difference between maximum length "L1" and minimum length "L3". In an example, the total adjustment length of tubing assembly <NUM> is between <NUM> and <NUM>. In another example, the total adjustment length of tubing assembly <NUM> is between <NUM> and <NUM>. In some examples, the total adjustment length of tubing assembly <NUM> is about <NUM> or about <NUM>.

Tubing assembly <NUM> may be manufactured using an injection molding process. Further, tubing assembly <NUM> may be formed as a single unitary member. Such a single unitary tubing assembly <NUM> having uniform material throughout may be simple to manufacture and may be cost effective. Alternatively, tubing assembly <NUM> may be formed from a number of separately formed components that are coupled together via a suitable process. For example, first and second adjustment members <NUM>, <NUM> may be manufactured as separate components that may be fixedly connected to corresponding tubular portion <NUM>, <NUM>.

<FIG> and <FIG> illustrate another design of a tubing assembly <NUM> for use with patient interface device <NUM> (see <FIG>) in delivering the flow of breathing gas to the airway of user <NUM> (see <FIG>). Tubing assembly <NUM> may be interchangeably referred to as tubing means <NUM>. With reference to <FIG>, tubing assembly <NUM> comprises a manifold portion <NUM> structured to be disposed generally atop user's head <NUM> (see <FIG>) and adapted to be coupled to conduit <NUM> (see <FIG>) carrying the flow of breathing gas. Manifold portion <NUM> may be interchangeably referred to as manifold means <NUM>. Manifold portion <NUM> is structured to be coupled to conduit <NUM>, such as via an elbow <NUM> having a tapered design or other suitable coupling member. Further, elbow <NUM> illustrated herein exhibits an anti-asphyxia feature.

Tubing assembly <NUM> further comprises a plurality of tubular portions <NUM>, <NUM>. Each tubular portion <NUM>, <NUM> extends from manifold portion <NUM> to a distal end <NUM> which is structured to be coupled to patient interface device <NUM>. Distal end <NUM> of tubular portion <NUM>, <NUM> is coupled to, and is in fluid communication with, patient interface device <NUM>. Further, each tubular portion <NUM>, <NUM> may be structured to communicate the flow of breathing gas from manifold portion <NUM> to patient interface device <NUM>. Specifically, manifold portion <NUM> provides fluid communication between conduit <NUM> and tubular portions <NUM>, <NUM>. When tubing assembly <NUM> is disposed on head <NUM> of user <NUM>, manifold portion <NUM> is disposed generally at the top of head <NUM> of user <NUM> and tubular portions <NUM>, <NUM> extend generally downward from manifold portion <NUM> to patient sealing element <NUM> (see <FIG>) of patient interface device <NUM>. In the illustrated embodiment of <FIG> and <FIG>, tubing assembly <NUM> comprises two tubular portions <NUM>, <NUM>.

Each of tubular portions <NUM>, <NUM> comprise a hollow passage (not shown) for allowing the flow of breathing gas therethrough. Tubular portions <NUM>, <NUM> are similar in design. Tubular portions <NUM>, <NUM> are symmetrical to each other with respect to manifold portion <NUM>. Tubular portions <NUM>, <NUM> are disposed at either sides of manifold portion <NUM> such that tubular portions <NUM>, <NUM> extend between manifold portion <NUM> and patient interface device <NUM>. In the illustrated embodiment of <FIG> and <FIG>, tubular portions <NUM>, <NUM> have an arcuate shape. In another exemplary embodiment, not shown, tubing assembly <NUM> may comprise a single tubular portion having a pair of arms resembling tubular portions <NUM>, <NUM> that extend centrally, i.e., from manifold portion <NUM> generally over head <NUM> and nose, to patient sealing element <NUM>.

As discussed above, tubular portions <NUM>, <NUM> are embodied as hollow members for allowing the flow of breathing gas to pass therethrough. In various exemplary embodiments, tubular portions <NUM>, <NUM> may have a generally non-circular cross-section, without any limitations. In an exemplary embodiment, tubular portions <NUM>, <NUM> may have a generally D-shaped cross-section. Further, each tubular portions <NUM>, <NUM> may define a patient facing portion <NUM> that comprises a generally flat side of the D-shape and is disposed adjacent head <NUM>. Further, a curved portion <NUM> of tubular portion <NUM>, <NUM> faces away from head <NUM>. In other exemplary embodiments, tubular portions <NUM>, <NUM> may have any other cross-section. It should be noted that patient facing portion <NUM> may comprise a particular surface texture or may be formed from a separate material that presents a comfortable feel for user <NUM>. Further, tubular portions <NUM>, <NUM> may encircle, or partially encircle, head <NUM> of user <NUM>. Accordingly, it is to be appreciated that tubing assembly <NUM>, as a result of its basic structure and positioning, may not only direct the flow of breathing gas to patient interface device <NUM>, but also generally functions as a frame that secures patient interface device <NUM> to head <NUM> of user <NUM>.

In an exemplary embodiment, tubing assembly <NUM> may further comprise one or more pad members (not shown) that may be used to vary a feel of tubing assembly <NUM> on head <NUM> of user <NUM> and/or to better fit tubing assembly <NUM> to head <NUM> of user <NUM>. In various exemplary embodiments, tubing assembly <NUM> may comprise one or more sections of removable cheek wraps (not shown), securable via suitable fasteners such as hook and loop (e.g., Velcro® fasteners) or other fasteners.

Further, in order to help secure patient interface device <NUM> and tubing assembly <NUM> to head <NUM> of user <NUM>, tubing assembly <NUM> may further comprise a support assembly (not shown). The support assembly may be similar to support assembly <NUM> described with reference to <FIG>. The support assembly may comprise a strap member that may be coupled to each tubular portion <NUM>, <NUM> by a mounting tab disposed on each tubular portion <NUM>, <NUM>. In other embodiments, tubing assembly <NUM> may omit the support assembly.

Further, a corresponding tubular portion <NUM>, <NUM> comprises a first tubular section <NUM> and a second tubular section <NUM> separate from first tubular section <NUM>. First and second tubular sections <NUM>, <NUM> may together define the hollow passage for passage of the flow of the breathing gas therethrough. First tubular section <NUM> may comprise a stepped design. First tubular section <NUM> may extend from manifold portion <NUM> and second tubular section <NUM> may comprise distal end <NUM>. Further, first tubular section <NUM> may comprise a gripping region <NUM> disposed adjacent to a first adjustment member <NUM> (shown in <FIG>). Gripping region <NUM> may comprise a plurality of dimples <NUM>. Dimples <NUM> may provide an improved gripping surface for user <NUM> while switching between different discrete positions. Moreover, second tubular section <NUM> may be distal from manifold portion <NUM> such that second tubular section <NUM> connects to patient interface device <NUM>.

Further, tubing assembly <NUM> comprises at least one adjustment unit <NUM>, <NUM> configured to adjust a length of corresponding tubular portion <NUM>, <NUM> from plurality of tubular portions <NUM>, <NUM>. Adjustment unit <NUM>, <NUM> may be interchangeably referred to as adjustment means <NUM>, <NUM>. In the illustrated embodiment of <FIG> and <FIG>, at least one adjustment unit <NUM>, <NUM> comprises a pair of adjustment units <NUM>, <NUM> disposed on opposing sides of manifold portion <NUM>. Specifically, tubing assembly <NUM> may comprise a first adjustment unit <NUM> and a second adjustment unit <NUM>. First adjustment unit <NUM> is configured to adjust the length of tubular portion <NUM> and second adjustment unit <NUM> is configured to adjust the length of tubular portion <NUM>. First and second adjustment units <NUM>, <NUM> are similar in design. First and second adjustment units <NUM>, <NUM> are symmetrical to each other with respect to manifold portion <NUM>. In other exemplary embodiments, it may be contemplated that tubing assembly <NUM> may comprise a single adjustment unit or more than two adjustment units. In the illustrated embodiment of <FIG> and <FIG>, adjustment units <NUM>, <NUM> are disposed proximal to manifold portion <NUM>. However, adjustment units <NUM>, <NUM> may be disposed at any other location along the length of corresponding tubular portion <NUM>, <NUM>.

As shown in <FIG>, at least one adjustment unit <NUM>, <NUM> comprises first adjustment member <NUM> integral with or fixedly connected to corresponding tubular portion <NUM>, <NUM> and a second adjustment member <NUM> integral with or fixedly connected to corresponding tubular portion <NUM>, <NUM>. Each adjustment unit <NUM>, <NUM> comprises one first adjustment member <NUM> and one second adjustment member <NUM>. One of first adjustment member <NUM> and second adjustment member <NUM> is disposed proximal to manifold portion <NUM>, and the other one of first adjustment member <NUM> and second adjustment member <NUM> is disposed distal to manifold portion <NUM>. In the illustrated embodiment of <FIG>, first adjustment member <NUM> is disposed proximal to manifold portion <NUM>, and second adjustment member <NUM> is disposed distal to manifold portion <NUM>. Further, in the illustrated embodiment of <FIG>, first adjustment member <NUM> is fixedly connected to first tubular section <NUM> and second adjustment member <NUM> is fixedly connected to second tubular section <NUM>. In other exemplary embodiments, first adjustment member <NUM> and second adjustment member <NUM> may be removably connected to first and second tubular sections <NUM>, <NUM>, respectively, by a snap fit, a press fit, adhesives, and the like.

Further, first adjustment member <NUM> and second adjustment member <NUM> are selectively and releasably locked to each other at a selected discrete position from a plurality of discrete positions. The plurality of discrete positions corresponds to a plurality of predetermined lengths of corresponding tubular portion <NUM>, <NUM>.

Further, tubing assembly <NUM> comprises a locking means <NUM> for selectively and releasably locking adjustment unit <NUM>, <NUM> at a selected discrete position from the plurality of discrete positions. Locking means <NUM> may comprise a protrusion <NUM> and a plurality of recesses <NUM>, <NUM>, <NUM> (shown in <FIG>).

First adjustment member <NUM> comprises an end <NUM> proximal to second tubular section <NUM> and an end <NUM> proximal to first tubular section <NUM>. In the illustrated embodiment of <FIG>, first adjustment member <NUM> is integral with first tubular section <NUM> and comprises protrusion <NUM> proximal to end <NUM> thereof. Dimensions of first tubular section <NUM> may be slightly greater than dimensions of first adjustment member <NUM>. Although a single protrusion <NUM> is illustrated herein, first adjustment member <NUM> may comprise more than one protrusion. In various exemplary embodiments, first adjustment member <NUM> may comprise three protrusions. Further, protrusion <NUM> may be disposed at any location on first adjustment member <NUM>. In the illustrated embodiment of <FIG>, protrusion <NUM> is substantially oval in shape. Alternatively, protrusion <NUM> may comprise any other shape, such as a substantially square shape, a substantially circular shape, a substantially rectangular shape, a substantially polygonal shape, and the like. In one exemplary embodiment, first tubular section <NUM> comprises a first material and first adjustment member <NUM> comprises a second material different from the first material. In various exemplary embodiments, the first material comprises silicone and the second material comprises polycarbonate. Alternatively, first tubular section <NUM> and first adjustment member <NUM> may be made of any other material, without any limitations.

Further, first adjustment member <NUM> and second adjustment member <NUM> are movable relative to each other. First adjustment member <NUM> is configured to be at least partially and slidably received within second adjustment member <NUM>. Specifically, first adjustment member <NUM> may be at least partially received within a hollow portion <NUM> defined by second adjustment member <NUM>. Accordingly, dimensions of second adjustment member <NUM> may be slightly greater than dimensions of first adjustment member <NUM> to allow receipt of first adjustment member <NUM> within second adjustment member <NUM>. Alternatively, first adjustment member <NUM> and second adjustment member <NUM> may be disposed such that second adjustment member <NUM> may be at least partially received within a hollow portion (not shown) defined by first adjustment member <NUM>, without any limitations.

Further, second adjustment member <NUM> is integral with second tubular section <NUM> and comprises plurality of recesses <NUM>, <NUM>, <NUM> corresponding to the plurality of discrete positions. Specifically, second adjustment member <NUM> comprises lugs <NUM>, <NUM>, <NUM> that project outwards from an outer surface <NUM> of second adjustment member <NUM>. As shown in <FIG>, lugs <NUM>, <NUM>, <NUM> define respective recesses <NUM>, <NUM>, <NUM>, such that recesses <NUM>, <NUM>, <NUM> face the hollow passage through which the breathing gas flows. Recesses <NUM>, <NUM>, <NUM> are equidistantly spaced apart from each other. Alternatively, recesses <NUM>, <NUM>, <NUM> may not be equidistantly spaced apart from each other and a placement of recesses <NUM>, <NUM>, <NUM> may vary based on a desired discrete position, without any limitations. Plurality of recesses <NUM>, <NUM>, <NUM> are configured to selectively, removably, and at least partially receive protrusion <NUM> (see <FIG>) of first adjustment member <NUM> (see <FIG>) therein in order to releasably lock first adjustment member <NUM> to second adjustment member <NUM>. Specifically, in response to sliding of first adjustment member <NUM> within second adjustment member <NUM>, first and/or second adjustment member <NUM>, <NUM> may be configured to deform in order to allow protrusion <NUM> to be selectively inserted into or removed from plurality of recesses <NUM>, <NUM>, <NUM>.

In the illustrated embodiment of <FIG>, second adjustment member <NUM> comprises three recesses <NUM>, <NUM>, <NUM> corresponding to the three discrete positions. Alternatively, second adjustment member <NUM> may comprise more than three recesses, or less than three recesses based on a total number of the discrete positions. Further, a shape of recesses <NUM>, <NUM>, <NUM> may be substantially similar to a shape of protrusion <NUM> so that protrusion <NUM> can be received within recesses <NUM>, <NUM>, <NUM>. In the illustrated embodiment of <FIG>, recesses <NUM>, <NUM>, <NUM> have an oval shape. Alternatively, recesses <NUM>, <NUM>, <NUM> may have a substantially square shape, a substantially circular shape, a substantially rectangular shape, a substantially polygonal shape, and the like. In other exemplary embodiments, when first adjustment member <NUM> at least partially receives second adjustment member <NUM>, first adjustment member <NUM> may comprise recesses <NUM>, <NUM>, <NUM>, whereas second adjustment member <NUM> may comprise protrusion <NUM>, without any limitations.

In an exemplary embodiment, recesses <NUM>, <NUM>, <NUM> may be replaced by through apertures (similar to through apertures <NUM>, <NUM>, <NUM> shown in <FIG>). In such an embodiment, second adjustment member <NUM> may omit lugs <NUM>, <NUM>, <NUM>. In other exemplary embodiments, first and second adjustment members <NUM>, <NUM> may be releasably locked with each other using any other means. For example, first and second adjustment members <NUM>, <NUM> may be releasably locked with each other by a press fit, a snap fit, a biasing mechanism, adhesives, or other fastening components such as snap fasteners, hook and loop fasteners, and the like, without any limitations.

Referring again to <FIG>, second adjustment member <NUM> may also comprise a number of size indicators <NUM>, <NUM>, <NUM> corresponding to different discrete positions. In the illustrated embodiment of <FIG>, second adjustment member <NUM> comprises size indicator <NUM> having a marking "L" which is an abbreviation for large size, such that when protrusion <NUM> is received within recess <NUM> (see <FIG>), size indicator <NUM> having marking "L" indicates to user <NUM> (see <FIG>) that tubing assembly <NUM> is in an extended position <NUM> (shown in <FIG>). Further, second adjustment member <NUM> comprises size indicator <NUM> having a marking "M" which is an abbreviation for medium size, such that when protrusion <NUM> is received within recess <NUM> (see <FIG>), size indicator <NUM> having marking "M" indicates to user <NUM> that tubing assembly <NUM> is in an intermediate position <NUM> (shown in <FIG>). Moreover, second adjustment member <NUM> comprises size indicator <NUM> having a marking "S" which is an abbreviation for small size, such that when protrusion <NUM> is received within recess <NUM> (see <FIG>), size indicator <NUM> having marking "S" indicates to user <NUM> that tubing assembly <NUM> is in a contracted position <NUM> (shown in <FIG>). It should be noted that markings used for size indicators <NUM>, <NUM>, <NUM> are exemplary in nature, and size indicators <NUM>, <NUM>, <NUM> may comprise any other type of marking, without any limitations. In other embodiments, size indicators <NUM>, <NUM>, <NUM> may be provided on first adjustment member <NUM> to provide user <NUM> with visual access regarding a current position of tubing assembly <NUM>. In such an embodiment, size indicators <NUM>, <NUM>, <NUM> may be marked on first adjustment member <NUM> such that size indicators <NUM>, <NUM>, <NUM> may be revealed to user <NUM> based on switching between the discrete positions for notifying user <NUM> regarding a current position of tubing assembly <NUM>.

In one exemplary embodiment, second tubular section <NUM> and second adjustment member <NUM> are made of a similar material. In an exemplary embodiment, second adjustment member <NUM> may be made of a deformable material. In various exemplary embodiments, second adjustment member <NUM> may comprise a transparent or translucent material to provide visual access to user <NUM> regarding a current position of tubing assembly <NUM>. In other embodiments, lugs <NUM>, <NUM>, <NUM> may be made of a transparent or translucent material. In various exemplary embodiments, each of second tubular section <NUM> and second adjustment member <NUM> comprises silicone. In various exemplary embodiments, tubular portions <NUM>, <NUM> may comprise one or more additional flexible sections that are integral with corresponding tubular portion <NUM>, <NUM>. For example, such flexible sections may be present between distal end <NUM> (see <FIG>) and corresponding adjustment unit <NUM>, <NUM>. The flexible sections may be similar to corrugated section <NUM> explained with reference to <FIG>, or the flexible sections may comprise any other design, without any limitations.

Various discrete positions associated with tubing assembly <NUM> will now be explained with reference to <FIG>, <FIG>, and <FIG>. <FIG> illustrates tubing assembly <NUM> in extended position <NUM>. For explanatory purposes, only tubular portion <NUM> and adjustment unit <NUM> are explained in detail with reference to <FIG>. However, it should be noted that details provided herein are equally applicable to tubular portion <NUM> and adjustment unit <NUM>. Extended position <NUM> may correspond to the maximum predetermined length such that tubing assembly <NUM> is usable by user <NUM> (see <FIG>) having a "large" head size. As illustrated in <FIG>, in extended position <NUM>, adjustable unit <NUM> has a maximum length "L4". In extended position <NUM>, protrusion <NUM> (see <FIG>) is received within recess <NUM> (see <FIG>). In one exemplary embodiment, tubing assembly <NUM> can slide up to two sizes, i.e., to intermediate position <NUM> and contracted position <NUM>.

As per application requirements, if tubing assembly <NUM> is to be disposed in intermediate position <NUM> or contracted position <NUM>, protrusion <NUM> is disengaged from recess <NUM>. Further, first and second adjustment members <NUM>, <NUM> are pushed towards each other until protrusion <NUM> engages with recesses <NUM> or <NUM> (see <FIG>) for disposing tubing assembly <NUM> in intermediate position <NUM> or contracted position <NUM>, respectively. It should be noted that when tubing assembly <NUM> switches to intermediate position <NUM> from extended position <NUM>, a length of adjustable unit <NUM> may decrease from maximum length "L4" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>. Similarly, when tubing assembly <NUM> switches to contracted position <NUM> from extended position <NUM>, the length of adjustable unit <NUM> may decrease from maximum length "L4" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>.

<FIG> illustrates tubing assembly <NUM> in intermediate position <NUM>. For explanatory purposes, only tubular portion <NUM> and adjustment unit <NUM> are explained in detail with reference to <FIG>. However, it should be noted that details provided herein are equally applicable to tubular portion <NUM> and adjustment unit <NUM>. Intermediate position <NUM> may correspond to the intermediate predetermined length, that is smaller than the maximum predetermined length, such that tubing assembly <NUM> is usable by user <NUM> (see <FIG>) having a "medium" head size. As illustrated in <FIG>, in intermediate position <NUM>, adjustable unit <NUM> has an intermediate length "L5". In intermediate position <NUM>, protrusion <NUM> (see <FIG>) is received within recess <NUM> (see <FIG>).

In one exemplary embodiment, tubing assembly <NUM> can elongate by one size, or tubing assembly <NUM> can contract by one size from intermediate position <NUM>. As per application requirements, if tubing assembly <NUM> is to be disposed in extended position <NUM> or contracted position <NUM>, protrusion <NUM> is disengaged from recess <NUM>. Further, for disposing tubing assembly <NUM> in extended position <NUM>, first and second adjustment members <NUM>, <NUM> are pulled away from each other until protrusion <NUM> engages with recess <NUM> (see <FIG>) for disposing tubing assembly <NUM> in extended position <NUM>. For disposing tubing assembly <NUM> in contracted position <NUM>, first and second adjustment members <NUM>, <NUM> are pushed towards each other until protrusion <NUM> engages with recess <NUM> (see <FIG>) for disposing tubing assembly <NUM> in contracted position <NUM>. It should be noted that when tubing assembly <NUM> switches to extended position <NUM> from intermediate position <NUM>, the length of adjustable unit <NUM> may increase from intermediate length "L5" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>. Similarly, when tubing assembly <NUM> switches to contracted position <NUM> from intermediate position <NUM> , the length of adjustable unit <NUM> may decrease from intermediate length "L5" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>.

<FIG> illustrates tubing assembly <NUM> in contracted position <NUM>. For explanatory purposes, only tubular portion <NUM> and adjustment unit <NUM> are explained in detail with reference to <FIG>. However, it should be noted that details provided herein are equally applicable to tubular portion <NUM> and adjustment unit <NUM>. Contracted position <NUM> may correspond to the minimum predetermined length, that is smaller than the intermediate predetermined length, such that tubing assembly <NUM> is usable by user <NUM> (see <FIG>) having a "small" head size. As illustrated in <FIG>, in contracted position <NUM>, adjustable unit <NUM> has a minimum length "L6". In contracted position <NUM>, protrusion <NUM> (see <FIG>) is received within recess <NUM> (see <FIG>). In one exemplary embodiment, tubing assembly <NUM> can elongate up to two sizes, i.e., to intermediate position <NUM> and extended position <NUM>. As per application requirements, if tubing assembly <NUM> is to be disposed in intermediate position <NUM> or extended position <NUM>, protrusion <NUM> is disengaged from recess <NUM>. Further, first and second adjustment members <NUM>, <NUM> are pulled away from each other until protrusion <NUM> engages with recesses <NUM> or <NUM> (see <FIG>) for disposing tubing assembly <NUM> in extended position <NUM> or intermediate position <NUM>, respectively. It should be noted that when tubing assembly <NUM> switches to intermediate position <NUM> from contracted position <NUM>, the length of adjustable unit <NUM> may increase from minimum length "L6" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>. Similarly, when tubing assembly <NUM> switches to extended position <NUM> from contracted position <NUM>, the length of adjustable unit <NUM> may increase from minimum length "L6" by a value between <NUM> and <NUM>, or a value between <NUM> and <NUM>.

Referring to <FIG>, in an example, a difference between maximum length "L4" and intermediate length "L5" is between <NUM> and <NUM>. In another example, the difference between maximum length "L4" and intermediate length "L5" is between <NUM> and <NUM>. In an example, a difference between intermediate length "L5" and minimum length "L6" is between <NUM> and <NUM>. In another example, the difference between intermediate length "L5" and minimum length "L6" is between <NUM> and <NUM>. In an example, a difference between maximum length "L4" and minimum length "L6" is between <NUM> and <NUM>. In an example, the difference between maximum length "L4" and minimum length "L6" is between <NUM> and <NUM>. Since each tubular portion <NUM>, <NUM> includes respective adjustable unit <NUM>, <NUM>, an overall length of tubing assembly <NUM> can be adjusted by a total adjustment length that is about twice a difference between maximum length "L4" and minimum length "L6". In an example, the total adjustment length of tubing assembly <NUM> is between <NUM> and <NUM>. In another example, the total adjustment length of tubing assembly <NUM> is between <NUM> and <NUM>. In some examples, the total adjustment length of tubing assembly <NUM> is about <NUM> or about <NUM>.

In various exemplary embodiments, one or more components of tubing assembly <NUM> may be manufactured using an injection molding process. Further, tubing assembly <NUM> may be formed from a number of separately formed components that are coupled together via a suitable process.

Referring to <FIG>, tubing assemblies <NUM>, <NUM> described herein may comprise fewer components and may be lightweight. Tubing assemblies <NUM>, <NUM> may not be bulky and may be easy to handle. Further, tubing assemblies <NUM>, <NUM> may be easy to use as users (e.g., user <NUM>) can easily switch between different discrete positions. Moreover, tubing assemblies <NUM>, <NUM> may allow the users to select and adjust tubing assemblies <NUM>, <NUM> to appropriate sizes thereby ensuring an improved fit and comfort. The users may also not be required to determine or calculate any adjustment positions as the discrete positions are predetermined by a manufacturer based on different head sizes. Additionally, the users may not have to assemble or disassemble any component of tubing assemblies <NUM>, <NUM> for switching between different discrete positions. Further, since first adjustment members <NUM>, <NUM> are integral with or fixedly connected to corresponding tubular portions <NUM>, <NUM>, <NUM>, <NUM> and second adjustment members <NUM>, <NUM> are integral with or fixedly connected to corresponding tubular portions <NUM>, <NUM>, <NUM>, <NUM>, first adjustment members <NUM>, <NUM> and second adjustment members <NUM>, <NUM> may not get misplaced and cause an inconvenience to the users.

<FIG> illustrates a flowchart for a method <NUM> for delivering the flow of breathing gas to the airway of user <NUM> (shown in <FIG>). Method <NUM> will be described with reference to tubing assembly <NUM>. However, in other exemplary embodiments, method <NUM> may be applicable to tubing assembly <NUM>.

At step <NUM>, method <NUM> comprises receiving, via manifold portion <NUM>, the flow of breathing gas from conduit <NUM>. At step <NUM>, method <NUM> comprises communicating, via tubular portion <NUM>, <NUM>, the flow of breathing gas from manifold portion <NUM> to patient interface device <NUM> that is sealingly engaged with airway of user <NUM>. At step <NUM>, method <NUM> comprises adjusting, via at least one adjustment unit <NUM>, <NUM>, the length of tubular portion <NUM>, <NUM>. At step <NUM>, method <NUM> comprises selectively and releasably locking at least one adjustment unit <NUM>, <NUM> at a selected discrete position from the plurality of discrete positions. The plurality of discrete positions corresponds to the plurality of predetermined lengths of tubular portion <NUM>, <NUM>.

There is thus provided a tubing assembly for use with a patient interface device and a method for delivering a flow of breathing gas to an airway of a user, which overcomes the existing problems.

In the present invention, the expression "at least one of A, B and C" means "A, B, and/or C", and that it suffices if, for example, only B is present.

Claim 1:
A tubing assembly (<NUM>) for use with a patient interface device (<NUM>) in delivering a flow of breathing gas to an airway of a user, the tubing assembly (<NUM>) comprising:
a manifold portion (<NUM>) structured to be disposed generally atop the user's head (<NUM>) and adapted to be coupled to a conduit carrying the flow of breathing gas;
a plurality of tubular portions (<NUM>, <NUM>) made from plastic and/or silicone, each tubular portion (<NUM>, <NUM>) extending from the manifold portion (<NUM>) to a distal end (<NUM>) which is structured to be coupled to the patient interface device (<NUM>), each tubular portion (<NUM>, <NUM>) being structured to communicate the flow of breathing gas from the manifold portion (<NUM>) to the patient interface device (<NUM>); and,
at least one adjustment unit (<NUM>, <NUM>) configured to adjust a length of a corresponding tubular portion (<NUM>, <NUM>) from the plurality of tubular portions (<NUM>, <NUM>), wherein the at least one adjustment unit (<NUM>, <NUM>) comprises a first adjustment member (<NUM>) integral with or fixedly connected to the corresponding tubular portion (<NUM>) and a second adjustment member (<NUM>) integral with or fixedly connected to the corresponding tubular portion (<NUM>, <NUM>), wherein the first adjustment member (<NUM>) and the second adjustment member (<NUM>) are movable relative to each other, and wherein the first adjustment member (<NUM>) and the second adjustment member (<NUM>) are selectively and releasably locked to each other at a selected discrete position from a plurality of discrete positions, the plurality of discrete positions corresponding to a plurality of predetermined lengths of the corresponding tubular portion (<NUM>, <NUM>),
characterized in that
the at least one adjustment unit (<NUM>, <NUM>) further comprises an adjustable section (<NUM>) integral with the corresponding tubular portion (<NUM>, <NUM>), wherein a relative movement between the first adjustment member (<NUM>) and the second adjustment member (<NUM>) causes the adjustable section (<NUM>) to elongate or contract, and wherein the adjustable section (<NUM>) is made from plastic and/or silicone.