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.

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 the formation of red marks on the patient's skin. Red marks are caused by many reasons, one of them including moisture trapped against the skin. Today, adhesives on the market use arrays of holes to allow for breathability of the skin. Many people are familiar with breathable Band-Aid® adhesive bandages that utilize such holes. Adhesive masks on the market are applied to the same portion of skin every single night. In order to have adequate seal the mask is always be applied the same, hence the adhesive element(s) thereof are also applied to the same portion of skin every single night. Because the adhesive mask is applied in the same location every night there can be a breakdown of skin over time due to the adhesive, not to mention increased red marks due to moisture build up.

<CIT> discloses adhesive nasal devices. In particular, the adhesive nasal respiratory devices described are configured to be worn in communication with a subject's nasal cavity and may include a rim body having a passageway therethrough, an airflow resistor in communication with the passageway of the rim body, and a flexible, adhesive holdfast layer extending outward from the periphery of the rim body. The rim body region may be formed from multiple parts (e.g., a first and a second rim body region), and the airflow resistor may be secured between the parts forming the rim body.

Accordingly, as one aspect of the present disclosure a securement arrangement for use in securing a patient interface to the skin of a patient comprises: a substrate material having a first surface; an adhesive material disposed on the first surface; and a release film disposed on the adhesive material. The release film is sectioned into a plurality of sections and at least one section of the plurality of sections includes a first indicator and a second section of the plurality of sections includes a second indicator different than the first indicator.

The first indicator may comprise at least one of a number or letter, and wherein the second indicator comprises at least one of a number or letter.

The first indicator may comprise a color and the second indicator may comprise another color.

At least a third section of the plurality of sections includes a third indicator different than the first indicator and the second indicator.

The planar substrate material may include a central portion having a plurality of tabs projecting outward therefrom, each of the tabs being structured to wrap up around, and be adhered to the nose of the patient.

As another aspect of the present disclosure, a kit comprises: a plurality of securement arrangements for use in securing a patient interface to the skin of a patient, each securement arrangement comprising: a substrate material having a first surface and an adhesive material disposed on the first surface. One of the securement arrangements of the plurality is structured to be adhered to a first area or group of areas of the patient and another one of the securement arrangements of the plurality is structured to be adhered to a second area or group of areas that differs from the first area or group of areas.

Each securement arrangement may further comprise a plurality of skin breathability holes, each skin breathability hole extending through the substrate material and the adhesive material, wherein the plurality of skin breathability holes of a first securement arrangement of the plurality of securement arrangements differs from the plurality of skin breathability holes of a second securement arrangement of the plurality of securement arrangements.

The plurality of skin breathability holes of the first securement arrangement may be positioned in a first pattern, and the plurality of skin breathability holes of the second securement arrangement may be positioned in a second pattern different than the first pattern.

The plurality of skin breathability holes of the first securement arrangement may be positioned in a first pattern, the plurality of skin breathability holes of the second securement arrangement may be positioned in a second pattern the same as the first pattern, and the second pattern may be positioned differently relative to the substrate material of the second securement arrangement than the first pattern relative to the substrate material of the first securement arrangement.

The plurality of skin breathability holes of a third securement arrangement of the plurality of securement arrangements may differ from the plurality of skin breathability holes each of the first securement arrangement and the second securement arrangement.

The plurality of skin breathability holes of a third securement arrangement of the plurality of securement arrangements may differ from the plurality of skin breathability holes of each of the first securement arrangement and the second securement arrangement, and the plurality of skin breathability holes of the third securement arrangement may be positioned in a third pattern different than each of the first pattern and the second pattern.

The plurality of skin breathability holes of a third securement arrangement of the plurality of securement arrangements may differ from the plurality of skin breathability holes of each of the first securement arrangement and the second securement arrangement, the plurality of skin breathability holes of the third securement arrangement may be positioned in a third pattern the same as the first pattern and the second pattern, and the third pattern may be positioned differently relative to the substrate material of the third securement arrangement than each of the first pattern relative to the substrate material of the first securement arrangement and the second pattern relative to the substrate material of the second securement arrangement.

The kit may further comprise the patient interface for use in providing a flow of breathing gas to the airway of the patient.

As yet another aspect of the present disclosure, a method of securing a patient interface to the skin of a patient using a securement arrangement from among a plurality of securement arrangements is provided. Each securement arrangement comprising a substrate material having a first surface and an adhesive material disposed on the first surface. The method comprises: selecting a first securement arrangement of a first design from among the plurality of securement arrangements; securing the patient interface to the patient by adhering the adhesive material of the first securement arrangement to the skin of the patient; detaching the first securement arrangement from the patient; selecting a second securement arrangement of a second design; and securing the second securement arrangement to the patient by adhering the adhesive material of the second securement arrangement to the skin of the patient.

These and other objects, features, and characteristics of the present disclosure, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. 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 disclosure 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> for use in providing a flow of a breathing gas to the airway of a patient (not shown) which may utilize a securement arrangement <NUM>, in accordance with one or more example embodiments of the present disclosure, for securing patient interface <NUM> to a patient. 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 disclosure, 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 that other arrangements of patient interface <NUM> may be employed without varying from the scope of the present disclosure.

Continuing to refer to <FIG>, securement arrangement <NUM> is provided for securing patient interface <NUM> to the face of a patient. Securement arrangement <NUM> may be mass produced or custom created for the dimensions of a particular patient and 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. In the example shown in <FIG>, planar substrate material <NUM> includes a central portion <NUM> having a number of tabs <NUM> projecting outward therefrom, with each of tabs <NUM> structured to wrap up around, and be secured to the patient's nose. It is to be appreciated that planar substrate material may be of other shapes and/or dimensions without varying from the scope of the present disclosure.

As discussed in greater detail below, securement arrangement <NUM> further includes an adhesive material <NUM> (shown schematically as hatching in <FIG>, 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. A removable layer of a release film <NUM> (only a portion of which is shown in <FIG>) may be provided covering adhesive material <NUM> for shielding adhesive material <NUM> until desired to be exposed and adhered to the skin of a patient.

In example system <NUM> illustrated in <FIG>, securement arrangement <NUM> is structured to be positioned generally between patient interface <NUM> and the skin of the patient. More particularly, securement 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>. Additionally, secondary adhesive arrangement <NUM> may include a foam core for providing dampening resulting from torque due to hose <NUM>. 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 substrate material <NUM>, and similarly secondary adhesive arrangement <NUM>, respectively includes a pair of apertures <NUM> and <NUM>, respectively, defined therein of similar, and preferably identical shape (e.g., to minimize turbulence, maximize comfort, etc.), as nasal apertures <NUM>.

Embodiments of the present disclosure vary areas of the patient's skin to which adhesives are placed on successive adhesive applications (e.g., during two or more successive nights for CPAP applications) in order to overcome undesirable shortcomings of conventional adhesive arrangements.

One approach in accordance with the present disclosure is to change the location of skin breathability holes provided in securement arrangements used on successive occasions, thus varying the areas exposed to ambient air and thus not subjected to adhesive. One example embodiment in accordance with such approach is illustrated in <FIG> which each show a different example securement arrangement 16A, 16B, 16C which may be employed securing patient interface <NUM> such as described in conjunction with <FIG>. Like securement arrangement <NUM> previously discussed, each securement arrangement 16A, 16B, 16C includes substrate material <NUM> having adhesive material <NUM> disposed on first planar surface <NUM> thereof. In the examples shown in <FIG>, each substrate material is of the same outer shape/dimensions. Unlike securement arrangement <NUM>, each securement arrangement 16A, 16B, 16C includes a plurality of skin breathability holes <NUM> extending through substrate material <NUM> and adhesive material <NUM>. Skin breathability holes <NUM> may be formed using a laser, die-cut, or via any suitable technique. Skin breathability holes <NUM> of each different securement arrangement 16A, 16B, 16C are positioned in a pattern PA, PB, PC different from the other securements arrangements 16A, 16B, 16C. Accordingly, by using a different one of securement arrangements 16A, 16B, 16C in successive applications, different areas of the skin of a patient are exposed to the breathability holes, and thus the ambient air, instead of adhesive material <NUM>. Although shown as three different securement arrangements 16A, 16B, 16C, it is to be appreciated that such quantity is shown for exemplary purposes only and that two or more different arrangements may be employed without varying from the scope of the present disclosure.

Another approach similar to the one described in conjunction with <FIG> for changing the location of skin breathability holes provided in securement arrangements used on successive occasions is to use the same pattern of skin breathability holes in different securement arrangements but to shift the positioning of such pattern in the different securement arrangements. <FIG> shows an example of superimposed securement arrangements <NUM>, <NUM>' and <NUM>" in accordance with one example embodiment of the present disclosure that illustrates such approach. Like securement arrangements <NUM>, 16A, 16B, 16C, previously discussed, securement arrangements <NUM>, <NUM>', <NUM>" include substrate material <NUM> of the same outer shape/dimension having adhesive material <NUM> disposed on first planar surface <NUM> thereof. Also, like securement arrangements 16A, 16B, 16C, securement arrangements <NUM>, <NUM>', <NUM>" include a plurality of skin breathability holes <NUM>, <NUM>', <NUM>" arranged in a predetermined pattern S, S', S". However, unlike securement arrangements 16A, 16B, 16C, second and third variations (<NUM>', <NUM>") of securement arrangement <NUM> includes the same pattern of breathability holes <NUM> but shifted in position, such as shown schematically by skin breathability holes <NUM>' and <NUM>" shown superimposed in order to illustrate the shifting positioning thereof. Accordingly, by using a different one of securement arrangements <NUM>, <NUM>', <NUM>" in successive applications, different areas of the skin of a patient are exposed to the breathability holes instead of adhesive material <NUM>. Although shown as three different securement arrangements <NUM>, <NUM>', <NUM>", it is to be appreciated that such quantity is shown for exemplary purposes only and that two or more different arrangements may be employed without varying from the scope of the present disclosure.

Another approach in accordance with the present disclosure is to vary the areas to which securement mechanism <NUM> is adhered to the patient by selectively varying the areas of adhesive material <NUM> that are actually exposed, and thus used in adhering securement arrangement <NUM> to the patient at a given time. Such approach is carried out by sectioning release film <NUM> into different areas or sections, such that for different applications the different areas or sections of release film <NUM> may be removed while other areas or sections are left in place, thus exposing different areas of adhesive material <NUM> for adhering to the patient. Some example embodiments of securement arrangements <NUM>, <NUM>, <NUM> utilizing such approach are shown in <FIG>. Each of such example embodiments utilize a substrate material, such as substrate material <NUM> previously described with an overlying adhesive material, such as adhesive material <NUM> previously discussed, disposed on the substrate material.

Referring to <FIG>, securement arrangement <NUM> includes a release film <NUM> that has been sectioned (e.g., via die cutting or any other suitable arrangement) into multiple sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> that may be selectively independently removed from securement arrangement <NUM>, thus exposing an underlying adhesive material (not numbered). In use, either: i. ) sections <NUM>, <NUM>, <NUM>, <NUM> and <NUM> are removed exposing underlying adhesive material (such as adhesive material <NUM> previously discussed) for adhering securement arrangement <NUM> to the patient (with section <NUM> shielding the patient from the adhesive material thereunder), or ii. ) only section <NUM> is removed exposing the underlying adhesive material for adhering securement arrangement <NUM> to the patient (with sections <NUM>, <NUM>, <NUM>, <NUM> and <NUM> shielding the patient from the adhesive material thereunder). By alternating which section(s) of release film <NUM> are removed on subsequent applications of embodiments of securement arrangement <NUM>, the same area of the patient's skin is not subjected to adhesive upon consecutive applications. In order to assist a patient or caregiver in removing the correct sections of release film <NUM>, one or more indicators <NUM> (e.g., without limitation, one or more of numbers, letters, words, colors, graphics, pictures, etc.) may be provided on each section. For example, in the embodiment shown in <FIG>, letter indicators <NUM> have been employed, hence section <NUM> has been labeled with the letter "A", while sections <NUM>, <NUM>, <NUM>, <NUM> and <NUM> have been labeled with the letter "B".

<FIG> shows a securement arrangement <NUM> similar to that of <FIG> except with the release film <NUM> thereof sectioned into more, smaller sections.

<FIG> shows a securement arrangement <NUM> similar to that of <FIG> except with sections of the release film <NUM> thereof labeled for three different possible arrangements, i.e., A, B, C of exposed adhesive.

Another approach in accordance with one example embodiment of the present disclosure is to vary the adhesive contact area by varying the shape of the substrate material used in as the main portion of a securement arrangement or via selective application of the adhesive material (e.g. via printing the adhesive or otherwise selectively placing) to only portions of the substrate material. <FIG> show profile views of a patient showing various different adhesive contact areas CA that may be employed in such arrangements in accordance with example embodiments of the present disclosure.

In applications where adhesive material(s) are selectively placed, one or more of the strength or type of adhesive may also be varied in order to provide a custom application tailored to meet the needs of a particular patient.

Claim 1:
A securement arrangement (<NUM>) for use in securing a patient interface (<NUM>) to the skin of a patient, the securement arrangement comprising:
a substrate material (<NUM>) having a first surface (<NUM>);
an adhesive material (<NUM>) disposed on the first surface; and
a release film (<NUM>) disposed on the adhesive material, wherein the release film is sectioned into a plurality of sections, and wherein at least one section of the plurality of sections includes a first indicator provided on the at least one section and at least one second section of the plurality of sections includes a second indicator provided on said at least one second section different than the first indicator.