Patent Description:
The present invention relates to non-invasive ventilation and pressure support systems wherein a patient interface device is used to deliver a flow of breathing gas to a patient and, more particularly, to a sealing arrangement for forming a seal between a patient and a patient interface device.

There are numerous situations where it is necessary or desirable to deliver a flow of breathing gas non-invasively to the 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 positive airway pressure (PAP) therapy to treat certain medical disorders, such as obstructive sleep apnea (OSA). Known PAP therapies include continuous positive airway pressure (CPAP), wherein a constant positive pressure is provided to the airway of the patient in order to splint open the patient's airway, and variable airway pressure, wherein the pressure provided to the airway of the patient is varied with the patient's respiratory cycle. Such therapies are typically provided to the patient at night while the patient is sleeping.

Recently, PAP machines have also been utilized in treating patients suffering from certain diseases that adversely affect the patient's lungs such as Coronavirus (COVID-<NUM>). However, gases expelled from such patients (e.g., via exhaling, coughing, sneezing) may be contaminated with the virus and thus can lead to infections to caregivers and others near the patient.

Non-invasive ventilation and pressure support therapies as just described involve a gas flow generator to produce a flow of breathing gas, and the placement of a patient interface device including a mask component on the face of a patient. The gas flow generator produces positive air pressure by taking air in from the surroundings and spinning a fan to push the air out of the machine, through a delivery conduit, and into the patient interface device to be delivered to the patient. Leak at the patient interface is a known issue for Non-Invasive Ventilation (NIV) Masks. Caregivers are currently instructed to allow some leak to reduce the risk of skin breakdown at the nose bridge. The masks are also known to generally leak. With the incidence of COVID-<NUM>, NIV masks put the caregivers and other patients at risk for infection.

Document <CIT> discloses a sealed face mask having a periphery including a seal that surrounds the nostrils and the mouth and that sticks to the skin of the face.

Document <CIT> discloses a removable nose pad cushion adherable to a medical face mask.

Document <CIT> discloses a patient interface having an attachment structure that couples with a complementary fixation structure positioned on the face of a patient.

Document <CIT> discloses a cushion pad for a mask word by a patient.

Document <CIT> discloses an elastic pressure sensitive adhesive member for an inhalation mask.

Document <CIT> discloses whole-nose nasal respiratory devices configured to be adhesively secured to a subject.

Document <CIT> discloses nasal devices adhesively coupled to a patient.

Embodiments of the present invention address shortcomings of conventional arrangements by generally providing a reusable leak-resistant or leak-proof seal at the interface between the patient and the patient interface device while allowing for a looser fit of the patient interface device on the face of the patient than conventional arrangements. As one aspect of the present invention a sealing arrangement for use in forming a seal between a face of a patient and a patient interface device for use in delivering a flow of a treatment gas to the patient is provided. The sealing arrangement comprises: a generally planar substrate body having a first side and a second side opposite the first side, the substrate body comprising a main portion having an opening defined therethrough, the opening being sized and configured to encompass the mouth and nose of the patient; a first adhesive layer disposed on the first side of the substrate body; and a second adhesive layer disposed on the second side of the substrate body, wherein the first adhesive layer is sized and configured to adhere to the skin of the patient adjacent the nose and mouth of the patient with a first adherence force, and wherein the second adhesive layer is sized and configured to adhere to a cushion of the patient interface device with a second adherence force less than the first adherence force.

The substrate body further comprises an extension tab extending from the main portion and including a portion of the first adhesive layer thereon, and wherein the extension tab does not include a portion of the second adhesive layer.

The extension tab may be sized and configured to extend downward along a first side of the mouth of the patient, across below the mouth of the patient, and upward along a second side of the mouth of the patient opposite the first side of the mouth when the sealing arrangement is positioned on the face of the patient with the opening encompassing the mouth and nose of the patient.

The substrate body may further comprise an alignment portion extending from the main portion.

The alignment portion may be delineated from the main portion by a separation feature.

The separation feature may comprise a locally thinned region extending between the alignment portion and the main portion in the substrate body.

The separation feature may comprise a plurality of separations defined through the substrate body.

The alignment portion may be sized and configured to engage a forehead support of the patient interface device.

As another aspect of the present invention an arrangement for use in delivering a flow of a treatment gas to the patient is provided. The arrangement comprises: a patient interface device having a cushion structured to sealingly engage about the mouth and nose of the patient; and a sealing arrangement comprising: a generally planar substrate body having a first side and a second side opposite the first side, the substrate body comprising a main portion having an opening defined therethrough, the opening being sized and configured to encompass the mouth and nose of the patient; a first adhesive layer disposed on the first side of the substrate body; and a second adhesive layer disposed on the second side of the substrate body, wherein the first adhesive layer is sized and configured to adhere to the skin of the patient adjacent the nose and mouth of the patient with a first adherence force, and wherein the second adhesive layer is adhered to the cushion of the patient interface device with a second adherence force less than the first adherence force.

The opening defined through the main portion of the substrate body may be larger than a corresponding patient opening of the cushion.

As yet another aspect of the present invention, a method of selectively sealing a cushion of a patient interface device to the face of a patient using a sealing arrangement as previously described is provided. The method comprises: coupling the substrate body of the sealing arrangement to the cushion with the second adhesive layer; coupling the substrate body and the cushion coupled to the substrate body to the face of the patient with the first adhesive layer; uncoupling the cushion from the substrate body while leaving the substrate body coupled to the face of the patient by separating the cushion from the first adhesive layer; and recoupling the cushion to the substrate body while the substrate body is coupled to the face of the patient via the first adhesive layer by re-adhering the second layer of the adhesive to the cushion.

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 (i.e., touching). 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 employed 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 employed herein, the term "number" shall mean one or an integer greater than one (i.e., a plurality). Directional phrases used herein, such as, for example and without limitation, left, right, upper, lower, front, back, on top of, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.

A system <NUM> (shown partially schematically) for providing a regiment of respiratory therapy to a patient (not shown) in which one exemplary embodiment of the present invention may be employed is generally shown in <FIG>. System <NUM> includes a pressure generating device <NUM> (shown schematically), a delivery conduit <NUM> (shown schematically), a patient interface device <NUM> having a fluid coupling conduit <NUM>, an upper frame <NUM> and a headgear <NUM>. Pressure generating device <NUM> is structured to generate a flow of breathing gas and may include, without limitation, ventilators, constant pressure support devices (such as a continuous positive airway pressure device, or CPAP device), variable pressure devices (e.g., BiPAP®, Bi-Flex®, or C-Flex™ devices manufactured and distributed by Philips Respironics of Murrysville, Pennsylvania), and auto-titration pressure support devices. Delivery conduit <NUM> is structured to communicate the flow of breathing gas from pressure generating device <NUM> to patient interface device <NUM> through fluid coupling conduit <NUM>. In the exemplary embodiment illustrated in <FIG>, fluid coupling conduit <NUM> is an elbow connector, however, it is to be appreciated that other suitable couplings may be employed without varying from the scope of the present invention. It is also to be appreciated that conduit <NUM> may be directly coupled to patient interface device <NUM> without the use of any intermediary coupling, such as conduit <NUM>.

A BiPAP® device is a bi-level device in which the pressure provided to the patient varies with the patient's respiratory cycle, so that a higher pressure is delivered during inspiration than during expiration. An auto-titration pressure support system is a system in which the pressure varies with the condition of the patient, such as whether the patient is snoring or experiencing an apnea or hypopnea. For present purposes, pressure/flow generating device <NUM> is also referred to as a gas flow generating device, because flow results when a pressure gradient is generated. The present invention contemplates that pressure/flow generating device <NUM> is any conventional system for delivering a flow of gas to an airway of a patient or for elevating a pressure of gas at an airway of the patient, including the pressure support systems summarized above and non-invasive ventilation systems.

Continuing to refer to <FIG>, patient interface device <NUM> includes a cushion <NUM> coupled to a main frame <NUM>. As commonly known, cushion <NUM> is generally formed from a soft, pliable material (e.g., without limitation, silicone) and is structured to sealingly engage face of the patient about the mouth and nares of the patient. As also commonly known, main frame <NUM> is generally formed from a rigid or semi-rigid material (e.g., without limitation, a polycarbonate material) and is structured to generally support cushion <NUM> in place on the face of a patient. Main frame <NUM> is pivotally coupled to upper frame <NUM> at a hinge <NUM> that provides for patient interface device <NUM> to be pivoted up and away from, and down and in engagement with the face of a patient while upper frame <NUM> is secured on the head of the patient via straps <NUM> and <NUM> provided as portions of headgear <NUM>. Meanwhile, straps <NUM> and <NUM>, provided as further portions of headgear <NUM>, may be selectively coupled to, and uncoupled from, patient interface device <NUM> to secure patient interface <NUM>, and thus cushion <NUM> thereof, to the face of the patient or allow for removal therefrom (without needing to remove or adjust upper frame <NUM> relative to the patient).

Although patient interface device <NUM> is depicted as a nasal/oral mask such as the AF531 Oro-nasal mask manufactured and distributed by Philips Respironics of Murrysville, Pennsylvania, it is to be appreciated that patient interface device <NUM> is provided for example purposes only and that embodiments of the present invention may be employed with patient interface devices of other designs from any manufacturer that facilitate the delivery of the flow of breathing gas to the airway of the user without varying from the scope of the present invention. It is also to be appreciated that headgear <NUM> is provided solely for exemplary purposes and that any suitable headgear arrangement may be employed without varying from the scope of the present invention.

Referring now to <FIG>, a sealing arrangement <NUM> in accordance with one example embodiment of the present invention for use in forming a generally leak-proof seal between a face of a patient and cushion <NUM> of patient interface device <NUM> (for use in delivering a flow of a treatment gas to the patient) is shown. As shown in the sectional view of <FIG>, sealing arrangement <NUM> includes a generally planar substrate body <NUM> having a first side <NUM> and a second side <NUM> opposite first side <NUM>. Substrate body <NUM> may be formed from a foam or other suitably compliant material or materials. As shown in <FIG>, substrate body <NUM> includes a main portion <NUM> having an opening <NUM> defined therethrough that is sized and configured to encompass the mouth and nose of a patient. In general, main portion <NUM> is generally sized like a 2D projection of the patient contacting portion of cushion <NUM>. In one example embodiment of the present invention, opening <NUM> is sized so as to be slightly larger than the corresponding patient opening of the cushion to which it is adhered.

In order to form the seal between the face of the patient and cushion <NUM> of patient interface device <NUM>, sealing arrangement <NUM> further includes a first adhesive layer <NUM> (shown as hatching in <FIG>) disposed on first side <NUM> of substrate body <NUM> and a second adhesive layer <NUM> (shown as hatching in <FIG>) disposed on second side <NUM> of substrate body <NUM>. First adhesive layer <NUM> is sized and configured (i.e., of a suitable arrangement and composition) to adhere to the skin of the patient adjacent the nose and mouth of the patient with a first adherence force. Second adhesive layer <NUM> is sized and configured (i.e., of a suitable arrangement and composition) to adhere to cushion <NUM> of patient interface device <NUM> with a second adherence force less than the first adherence force. Such difference between the first and second adherence forces provides for cushion <NUM> to be un-adhered (i.e., separated) from sealing arrangement <NUM> while sealing arrangement <NUM> is adhered to the face of the patient.

Continuing to refer to <FIG>, in order to increase the strength of the adherence of sealing arrangement <NUM> to the face of the patient and/or to assist in unadherence/removal of cushion <NUM> from sealing arrangement <NUM> while sealing arrangement <NUM> is adhered to the patient, substrate body <NUM> further includes an extension tab <NUM> that extends from main portion <NUM>. As shown in <FIG>, first adhesive layer <NUM> extends onto extension tab <NUM>, hence extension tab <NUM> includes a portion of first adhesive layer <NUM> thereon. As shown in <FIG>, second adhesive layer <NUM> does not extend onto extension tab <NUM>, hence extension tab <NUM> does not include a portion of second adhesive layer <NUM>. The outward facing side of extension tab <NUM> (i.e., the continuation of second side <NUM> of substrate body <NUM>) is left unsticky, so as to provide a gripping/holding surface for assisting in maintaining adherence of sealing arrangement to the face of the patient while cushion <NUM> is un-adhered/removed therefrom, as discussed further below.

In the one example embodiment shown in <FIG>, extension tab <NUM> is sized and configured to extend downward along a first side of the mouth of the patient, across below the mouth of the patient, and upward along a second side of the mouth of the patient opposite the first side of the mouth when the sealing arrangement is positioned on the face of the patient with opening <NUM> encompassing the mouth and nose of the patient.

In order to assist in properly initially aligning sealing arrangement <NUM> with patient interface <NUM> and cushion <NUM> thereof, substrate body <NUM> of sealing arrangement <NUM> may further comprise an alignment portion <NUM> that extends from main portion <NUM>. Alignment portion <NUM> may be delineated from main portion <NUM> by a separation feature <NUM> (shown in dashed line in <FIG>) that generally provides for a one-time uncoupling of alignment portion <NUM> from main portion <NUM>. In one example embodiment of the present invention separation feature <NUM> includes a locally thinned region (e.g., a groove or score) extending between alignment portion <NUM> and main portion <NUM> that has been formed in substrate body <NUM>. In one example embodiment of the present invention separation feature <NUM> includes a plurality of separations defined through substrate body <NUM>. In one example embodiment such as shown in <FIG>, alignment portion <NUM> is sized and configured to engage a forehead support of a patient interface device, such as forehead support <NUM> of patient interface device <NUM> of <FIG>.

Having thus described one example embodiment of sealing arrangement <NUM> in accordance with the present invention, a method of using sealing arrangement <NUM> to selectively seal cushion <NUM> of patient interface <NUM> of <FIG> to a patient will now be described in conjunction with <FIG>. Referring first to <FIG>, sealing arrangement <NUM> is prepared and test fit to patient interface device <NUM>. In such example, such preparation includes bending a number of fitment tabs <NUM> (only one is numbered) provided with alignment portion <NUM> in order to engage alignment portion <NUM> with a portion (e.g., without limitation, a rectangular forehead pad) of forehead support <NUM> of patient interface device <NUM>.

Moving on to <FIG>, after test fitting sealing arrangement <NUM> to patient interface device <NUM>, sealing arrangement <NUM> is removed therefrom and a release layer <NUM> covering at least second adhesive layer <NUM> is removed from sealing arrangement <NUM>. In the example shown in <FIG>, release layer <NUM> not only covers second adhesive layer <NUM> but additionally covers at least a portion of extension tab <NUM>. Hence, such arrangement provides for an easy peel tab on release layer <NUM> since the portion thereof overlying extension tab <NUM> is not adhered to extension tab <NUM> by any adhesive material. Now that second adhesive layer <NUM> has been exposed, sealing arrangement <NUM> is aligned with patient interface device <NUM> by aligning alignment portion <NUM> with forehead support <NUM> and slowly bringing second adhesive layer <NUM> into contact with cushion <NUM> of patient interface device <NUM>, such as generally shown in <FIG>. Next, as shown in <FIG>, main portion <NUM> of sealing arrangement <NUM>, and particularly the outer perimeter thereof, is pressed against cushion <NUM> to ensure good adherence between sealing arrangement <NUM> and cushion <NUM>. After main portion <NUM> of sealing arrangement <NUM> has been sufficiently adhered to cushion <NUM>, alignment portion <NUM> of sealing arrangement <NUM> is disengaged from patient interface device <NUM> and uncoupled from main portion <NUM>. In the example shown in <FIG>, a second release layer <NUM> covering first adhesive layer <NUM> is coupled to alignment portion <NUM> and thus is removed from sealing arrangement <NUM> along with alignment portion <NUM>, thus exposing first adhesive layer <NUM> of sealing arrangement <NUM>. It is to be appreciated that such arrangement of alignment portion <NUM> and second release layer <NUM> generally serves to provide an easy pull tab, i.e., alignment portion <NUM>, for removing second release layer <NUM>.

Moving on now to <FIG>, after first adhesive layer has been exposed, patient interface <NUM> and sealing arrangement <NUM> adhered thereto are aligned and adhered to the face of the patient (not numbered). Such adherence may be accomplished by grasping and pressing patient interface <NUM> toward the face of the patient. To firm up the seal between sealing arrangement <NUM> and the face of the patient, extension tab <NUM> is also pressed along the length thereof to ensure adhesion thereof near the mouth and chin of the patient. After sealing arrangement <NUM> and patient interface device <NUM> have been adhered to the face of the patient, upper frame <NUM> is coupled to main frame <NUM> of patient interface device <NUM> and the assembly is further secured to the head of the patient via headgear <NUM>, such as generally shown in <FIG>. Upon completion of such steps, patient interface device <NUM> is sealingly engaged to the face of the patient via sealing arrangement <NUM> and thus ready for coupling to, and receiving a flow of a treatment gas from, pressure generating device <NUM>.

If/when a need arises for patient interface device <NUM> to be temporarily removed from the face of the patient, sealing arrangement <NUM> may be generally held in place on the face of the patient by pressing against extension tab <NUM> as shown in <FIG>. Next, as shown in <FIG>, patient interface device <NUM> is separated/un-adhered from second adhesive layer <NUM> by grasping main frame <NUM> thereof and pulling away from the face of the patient and sealing arrangement <NUM>. As shown in <FIG>, patient interface device <NUM>, and more particularly cushion <NUM> thereof, may be re-adhered/sealed to the face of the patient simply by moving cushion <NUM> back into contact with second adhesive layer <NUM> and pressing patient interface device <NUM> into engagement therewith to ensure adequate adherence/seal. The remaining portions of sealing arrangement <NUM>, i.e., main portion <NUM> and extension tab <NUM> may be removed/un-adhered from the face of the patient simply by grasping and peeling away from the face of the patient, such as shown in <FIG>. As shown in such FIGS. , removal of such remaining portions may be accomplished by starting at the top of the nose and peeling generally downward, inline with the skin of the patient.

From the foregoing description it is thus to be appreciated that embodiments of the present invention provide arrangements that improve the seal between a patient interface device and the face of a patient. It is also to be appreciated that such arrangements reduce the potential for Medical Adhesive Related Skin Injury (MARSI) to occur by reducing the need to adhere/remove an adhesive from the skin of the patient multiple times in a given period by providing for the adhesive to remain on the patient while the patient interface device is removed. In a normal use case (i.e., a conventional NIV usage in a non COVID-<NUM> situation), an NIV mask can be removed an average of <NUM> times a day. With the COVID-<NUM> pandemic use case, the conventional masks can be expected to be removed around <NUM> times a day (less to prevent viral spread). Adhesive removal in a repeated area even <NUM> times a day, puts patients at a high risk for MARSI. Sealing arrangement in accordance with example embodiments of the present invention overcome this issue by remaining on the face of the patient while allowing the mask/patient interface device to be removed and reapplied a number of times (at minimum <NUM>).

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 sealing arrangement (<NUM>) for use in forming a seal between a face of a patient and a patient interface device (<NUM>) for use in delivering a flow of a treatment gas to the patient, the sealing arrangement comprising:
a generally planar substrate body (<NUM>) having a first side and a second side opposite the first side, the substrate body comprising a main portion having an opening defined therethrough, the opening being sized and configured to encompass the mouth and nose of the patient;
a first adhesive layer (<NUM>) disposed on the first side (<NUM>) of the substrate body; and
a second adhesive layer (<NUM>) disposed on the second side (<NUM>) of the substrate body,
wherein the first adhesive layer is sized and configured to adhere to the skin of the patient adjacent the nose and mouth of the patient with a first adherence force, and
wherein the second adhesive layer is sized and configured to adhere to a cushion of the patient interface device with a second adherence force less than the first adherence force, and
characterized in that the substrate body further comprises an extension tab (<NUM>) extending from the main portion and including a portion of the first adhesive layer thereon, and in that the extension tab does not include a portion of the second adhesive layer.