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 airflow.

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 airflow. 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 member 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 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.

<CIT> discloses a patient interface system includes a nasal seal of flexible material to communicate with at least one airway of the patient, and a primary headgear from which the nasal seal is suspended, said primary headgear having at least one aperture though which at least a portion of the nasal seal is inserted with the primary headgear wrapping about at least one portion of the nasal seal in a sling-like fashion.

Traditionally, such patient interface devices have been secured to the face/head of the patient by a headgear component having one or more straps which wrap around all, or a portion, of the patient's head. Recently, adhesive arrangements have been employed, either in-whole, or in-part, to secure patient interface devices to the face of a patient. In such arrangements, many concerns/complaints are related to the strength of the adhesive and the ease of removal of the adhesive. Another major concern/complaint is alignment of the adhesive arrangement used to secure the patient interface with the patient interface itself as misalignment of such elements will result in a low quality fitment which is uncomfortable to patient and may not provide proper treatment due to leaks.

Accordingly, as one aspect of the present invention a system for aligning a patient interface for use in delivering a flow of a breathing gas to the airway of a patient with an adhesive arrangement structured to secure the patient interface to the patient is provided. The system comprises the features defined in claim <NUM>.

The patient interface may be a nasal mask having the pair of nasal apertures, and each protruding alignment element may be sized and configured to cooperatively engage a corresponding nasal aperture of the patient interface device.

The nasal apertures may be defined within a contoured surface of the patient interface, and the contoured surface of the base may be of a shape which is structured to coincide with the contoured surface of the patient interface.

The system may further comprise a clamping arrangement moveably coupled to the base, the clamping arrangement being structured to hold the adhesive arrangement in a predetermined position on the base.

The base may comprise a first support surface structured to support a portion of the adhesive arrangement and a second support surface structured to support another portion of the adhesive arrangement; and the clamping member may comprise: a first clamping surface; and a second clamping surface, wherein the clamping arrangement is movable relative to the base between: a first positioning in which the first clamping surface is disengaged and spaced from the first support surface and the second clamping surface is disengaged and spaced from the second support surface, and a different second positioning in which the first clamping surface is engaged, directly or indirectly with the first support surface and the second clamping surface is engaged, directly or indirectly with the second support surface. The clamping arrangement may comprise a first arm member having a first end and an opposite second end and a second arm member having a first end and an opposite second end; wherein the first end of the first arm member is moveably coupled to the base; wherein the first end of the second arm member is moveably coupled to the base; wherein the first clamping surface is disposed at or about the second end of the first arm member; and wherein the second clamping surface is disposed at or about the second end of the second arm member. The first arm member may comprise a first portion of a unitary member moveably coupled to the base and the second arm member may comprise a second portion of the unitary member. The unitary member may be pivotally coupled to the base.

The base may be formed from an additive manufacturing process. The base may be dimensioned, at least in-part, based on dimensions obtained from the patient. The contoured surface of the base may be dimensioned based on facial dimensions of the patient. The first support surface, the second support surface, the first clamping surface, and the second clamping surface may be positioned and shaped based on facial dimensions of the patient.

The base may further comprise a custom indicia selected by the patient integrally formed therewith.

As another aspect of the present invention a method of aligning a patient interface for use in delivering a flow of a breathing gas to the airway of a patient with a primary adhesive arrangement structured to secure the patient interface to the patient using a system is provided. The system comprises: a base structured to be disposed on a surface, the base comprising a central member protruding upward from the base to a contoured surface, the central member including a pair of protruding alignment elements extending further upward from the contoured surface. The method comprises: positioning the primary adhesive arrangement on the base such that a pair of first apertures of the primary adhesive arrangement are positioned such that the pair of protruding alignment elements of the base extend through the pair of first apertures; positioning a secondary adhesive arrangement on the primary adhesive arrangement such that a pair of second apertures of the secondary adhesive arrangement are positioned such that the pair of protruding alignment elements of the base extend through the pair of second apertures; and positioning the patient interface on the secondary adhesive arrangement such that a pair of nasal apertures of the patient interface are positioned such that the pair of protruding alignment elements of the base extend through the pair of nasal apertures.

The base may further comprise a clamping arrangement moveably coupled to the base, the clamping arrangement being structured to hold the primary adhesive arrangement in a predetermined position on the base; and the method may further comprise securing the primary adhesive arrangement to the base with the clamping arrangement prior to positioning the secondary adhesive arrangement on the primary adhesive arrangement.

As used in the specification and in the claims, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed example embodiments described herein are merely exemplary of the invention, which may be embodied in various forms.

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 coupled 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, 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).

<FIG> is a simplified perspective front view of an airway pressure support system <NUM> including a patient interface assembly <NUM> having a patient interface <NUM> and an adhesive arrangement <NUM> for use in providing a flow of a breathing gas to the airway of a patient (not shown) which may be aligned utilizing an alignment system in accordance with one non-limiting example embodiment of the present invention. Airway pressure support system <NUM> includes a gas flow generator <NUM> (shown schematically) and a hose <NUM> (partially shown schematically) having a first end (not numbered) coupled to gas flow generator <NUM> and an opposite second end (not numbered) coupled to patient interface <NUM>. Gas flow generator <NUM> is structured to generate a flow of breathing gas to be delivered to an airway of a patient via hose <NUM> and patient interface <NUM>.

In the example arrangement shown in <FIG>, patient interface <NUM> is in the form of a cradle-like nasal interface for generally engaging the underside of the nose of a patient. Accordingly, patient interface <NUM> includes a pair nasal apertures <NUM> defined in a contoured surface <NUM>. In one example embodiment of the present invention, contoured surface <NUM> and each nasal aperture <NUM> is custom dimensioned/formed based on facial dimensions of a particular patient. Such custom dimensioning/forming may readily be carried out using 3D scanning and printing techniques known in the art. It is to be appreciated however, that other arrangements of patient interface <NUM> may be employed without varying from the scope of the present invention.

Continuing to refer to <FIG>, adhesive arrangement <NUM> is provided for securing patient interface <NUM> to the face of a patient. Adhesive arrangement <NUM> is formed from a generally thin (e.g., having a thickness of at least <NUM>) substantially planar substrate material <NUM> having a first planar surface <NUM>, which faces toward a patient, and a second planar surface <NUM>, opposite first planar surface <NUM>, which faces toward patient interface <NUM>. Planar substrate material <NUM> may generally be any pliable material such as, for example, without limitation, foam, silicone polyurethane, latex, or any other suitable material. Planar substrate material <NUM> includes a main portion <NUM> having a number of tabs <NUM> projecting outward therefrom. Adhesive arrangement <NUM> further includes an adhesive material <NUM> (shown schematically as hatching, e.g., without limitation, a silicone or acrylic based adhesive layer or any other suitable adhesive layer) provided on first planar surface <NUM> for use in adhering adhesive arrangement <NUM> to the skin of a patient. In one embodiment, a layer of a release film <NUM> (only a portion of which is shown in <FIG>) is provided covering adhesive material <NUM> for shielding adhesive material <NUM> until desired to be adhered to the skin of a patient.

After removing the aforementioned release film, and prior to adhering substrate material <NUM> to the skin of a patient, each tab <NUM> is folded back onto main portion <NUM> such that the adhesive material <NUM> on tab <NUM> is adhered to the adhesive material <NUM> on main portion <NUM>, thus fixing each tab <NUM> in a positioning on first planar surface <NUM>. As adhesive material <NUM> is only disposed on first planar surface <NUM> portion of each tab <NUM> and not on the second planar surface <NUM>, such positioning of tabs <NUM> on first planar surface <NUM> effectively provides for a non-adhesive area extending from a periphery P of main portion <NUM> that is generally surrounded by adhesive material <NUM> by about <NUM> degrees, if not more. Such non-adhesive areas provide for an underlying area that can be readily engaged by a fingertip of a patient, and gripped via a thumb positioned on second planar surface <NUM> of main portion <NUM> opposite such non-adhesive area in order to peel away all, or selected portions of adhesive arrangement <NUM> from the skin of the patient.

In example system <NUM> illustrated in <FIG>, adhesive arrangement <NUM> is structured to be positioned generally between patient interface <NUM> and the skin of the patient. More particularly, adhesive arrangement <NUM> is structured to be positioned between contoured surface <NUM> of patient interface <NUM> and the skin of the patient and secured to contoured surface <NUM> via a secondary adhesive arrangement <NUM> (e.g., a single layer material having upper and lower adhesive surfaces integral therewith or applied thereto) which may be disposed directly on second planar surface <NUM> of substrate material <NUM>, or alternatively, as a separate element, such as shown in the example of <FIG>. In order to provide for a reliable seal about each nare of the patient, and to allow for the passage of the flow of breathing gas from each of nasal apertures <NUM> of patient interface <NUM> to the respective nares of the patient, each of adhesive substrate material <NUM>, and similarly secondary adhesive arrangement <NUM>, respectively includes a pair of apertures <NUM> and <NUM> defined therein of similar, and preferably identical shape (e.g., to minimize turbulence, maximize comfort, etc.), as nasal apertures <NUM>.

Referring now to <FIG>, a system <NUM> for readily and predictably aligning patient interface <NUM>, adhesive arrangement <NUM>, and secondary adhesive arrangement <NUM>. System <NUM> includes a base <NUM> that is structured to be disposed on a surface (e.g., without limitation, a table, counter, nightstand, etc.) and a clamping arrangement <NUM> moveably coupled to base <NUM> that is structured to generally hold adhesive arrangement <NUM> in a predetermined position on base <NUM>.

Base <NUM> includes a central member <NUM> protruding upward therefrom to a contoured surface <NUM> which, in one example embodiment of the present invention is of a shape which is structured to coincide with contoured surface <NUM> of patient interface <NUM>. A pair of protruding alignment elements <NUM> extend further upward from contoured surface <NUM>. In the one example embodiment shown in the figures, each protruding alignment element <NUM> is sized and configured so as to cooperatively engage a respective one of apertures <NUM> of adhesive arrangement <NUM>, a respective one of one of apertures <NUM> of secondary adhesive arrangement <NUM>, and a corresponding one of nasal apertures <NUM> of patient interface <NUM>, as discussed further below in conjunction with <FIG>. Base <NUM> further includes a first support surface <NUM> structured to support a portion of adhesive arrangement <NUM> and a second support surface <NUM> structured to support another portion of adhesive arrangement <NUM>.

Continuing to refer to <FIG>, clamping arrangement <NUM> includes a first clamping surface <NUM> and a second clamping surface <NUM>. Clamping arrangement <NUM> is movable relative to base <NUM> between: a first positioning (i.e., open position, e.g., see <FIG>) in which first clamping surface <NUM> is spaced from first support surface <NUM> and second clamping surface <NUM> is spaced from second support surface <NUM>, and a different second positioning (i.e., closed position, e.g., see <FIG>) in which first clamping surface <NUM> is engaged, directly or indirectly (i.e., via adhesive arrangement <NUM> such as shown in <FIG>) with first support surface <NUM> and second clamping surface <NUM> is engaged, directly or indirectly (i.e., via adhesive arrangement <NUM> such a s shown in <FIG>) with second support surface <NUM>. In example embodiments of the present invention, magnets and/or other suitable latching and/or locking mechanisms have been employed to maintain clamping arrangement <NUM> in the aforementioned second positioning.

From the foregoing it is thus to be appreciated that when clamping arrangement <NUM> is disposed in the aforementioned first positioning, adhesive arrangement <NUM> may be placed on base <NUM> with apertures <NUM> thereof positioned such that alignment elements <NUM> extend therethrough, and thus release material <NUM> disposed on adhesive material <NUM> is engaged with contoured surface <NUM> of base <NUM>. Once adhesive arrangement <NUM> is positioned accordingly, clamping arrangement <NUM> is moved to such second positioning and adhesive arrangement <NUM> is secured by clamping arrangement <NUM> to base <NUM> in an aligned position therewith, such as shown in <FIG>. After adhesive arrangement <NUM> has been secured to base <NUM>, secondary adhesive arrangement <NUM> is placed on adhesive arrangement <NUM> with apertures <NUM> thereof positioned such that alignment elements <NUM> extend therethrough, and thus a first adhesive surface 38A of secondary adhesive arrangement <NUM> is directly engaged with and adhered to second planar surface <NUM> of adhesive arrangement <NUM>. Finally, patient interface <NUM> is placed on secondary adhesive arrangement <NUM> with nasal apertures <NUM> thereof positioned such that alignment elements <NUM> extend therethrough, and thus countered surface <NUM> of patient interface <NUM> is directly engaged with and adhered to a second adhesive surface 38B (opposite first adhesive surface 38A) of secondary adhesive arrangement <NUM>. After all of the aforementioned components are aligned and adhered together, clamping arrangement <NUM> is returned to the first positioning and the assembly of patient interface <NUM> and adhesive arrangement <NUM> is removed from system <NUM> for use by a patient.

In the example shown in <FIG>, clamping arrangement <NUM> includes: a first arm member <NUM> having a first end 120A and an opposite second end 120B, and a second arm member <NUM> having a first end 122A and an opposite second end 122B. First end 120A is moveably coupled to base <NUM> and first end 122A of second arm member <NUM> is moveably coupled to base <NUM>. First clamping surface <NUM> is disposed at or about second end 120B of first arm member 120A and second clamping surface <NUM> is disposed at or about second end 122B of second arm member <NUM>. In the example of <FIG>, first arm member <NUM> and second arm member <NUM> are each formed as portions of a single unitary member <NUM> which is coupled to base <NUM> via a hinge-like arrangement <NUM> such that unitary member <NUM> may pivot about a pivot axis <NUM> (<FIG> and <FIG>). Hence, it may be said that clamping arrangement <NUM> is pivotally coupled to base <NUM>.

In one example embodiment in accordance with the present invention base <NUM> was formed as a product of an additive manufacturing process (e.g., 3D printing) using dimensions obtained (e.g., via facial scan, direct measurement, etc.) from the patient for which patient interface <NUM> was intended. In such embodiment, contoured surface <NUM> was dimensioned/shaped based on facial dimensions of the patient. Furthermore, first support surface112, second support surface <NUM>, first clamping surface116, and second clamping surface <NUM> were also positioned and shaped based on facial dimensions of the patient. As shown in the example of <FIG>, custom indicia <NUM> may be provided on either or both of base <NUM> and/or clamping arrangement <NUM> as an integral portion thereof. Custom indicia <NUM> may be in the form of a name or other identifier for the patient, a custom design or graphic, or other graphical element assigned to, or selected by the patient.

From the foregoing, it is thus to be appreciated that the disclosed concept provides for a system for aligning one or more adhesive components used in securing a patient interface to the face of a patient with an interface device intended for use by the patient in receiving a flow of a breathing gas.

The word "comprising" or "including" does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

Claim 1:
A system (<NUM>) for aligning a patient interface (<NUM>) for use in delivering a flow of a breathing gas to the airway of a patient, the system comprising: a primary adhesive arrangement (<NUM>) structured to secure the patient interface to the patient, and a base (<NUM>) structured to be disposed on a surface, the base comprising a central member (<NUM>) protruding upward from the base to a contoured surface (<NUM>), the central member including a pair of protruding alignment elements (<NUM>) extending further upward from the contoured surface, wherein
the primary adhesive arrangement comprises a pair of first apertures (<NUM>) which are adapted to be positioned such that the pair of protruding alignment elements of the base extend through the pair of first apertures; characterized in that
the system comprises a secondary adhesive arrangement (<NUM>) comprising a pair of second apertures (<NUM>) which are adapted to be positioned such that the pair of protruding alignment elements of the base extend through the pair of second apertures; and
the patient interface comprises a pair of nasal apertures (<NUM>) which are adapted to be positioned such that the pair of protruding alignment elements of the base extend through the pair of nasal apertures.