Patent Publication Number: US-2021187233-A1

Title: Adhesive skin application system

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application claims the priority benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 62/950,571, filed on Dec. 19, 2019, the contents of which are herein incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to systems for securing a patient interface, such as a nasal mask, with an adhesive arrangement to the face of a patient. More particularly, the present invention relates to a system for use in aligning and applying an adhesive arrangement to a patient interface and for aligning and adhering the adhesive arrangement along with the patient interface to the skin of the patient. The present invention also relates to methods of using the aforementioned system. 
     2. Description of the Related Art 
     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&#39;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 90% or greater reduction in peak respiratory air-flow. 
     Those afflicted with sleep apnea experience sleep fragmentation and complete or nearly complete cessation of ventilation intermittently during sleep with potentially severe degrees of oxyhemoglobin desaturation. These symptoms may be translated clinically into extreme daytime sleepiness, cardiac arrhythmias, pulmonary-artery hypertension, congestive heart failure and/or cognitive dysfunction. Other consequences of sleep apnea include right ventricular dysfunction, carbon dioxide retention during wakefulness, as well as during sleep, and continuous reduced arterial oxygen tension. Sleep apnea sufferers may be at risk for excessive mortality from these factors as well as by an elevated risk for accidents while driving and/or operating potentially dangerous equipment. 
     Even if a patient does not suffer from a complete or nearly complete obstruction of the airway, it is also known that adverse effects, such as arousals from sleep, can occur where there is only a partial obstruction of the airway. Partial obstruction of the airway typically results in shallow breathing referred to as a hypopnea. A hypopnea is typically defined as a 50% or greater reduction in the peak respiratory air-flow. Other types of sleep disordered breathing include, without limitation, upper airway resistance syndrome (UARS) and vibration of the airway, such as vibration of the pharyngeal wall, commonly referred to as snoring. 
     It is well known to treat sleep disordered breathing by applying a continuous positive air pressure (CPAP) to the patient&#39;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&#39;s breathing cycle, or varies with the patient&#39;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&#39;s nose, a nasal/oral mask that covers the patient&#39;s nose and mouth, or a full face mask that covers the patient&#39;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&#39;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 ability to apply the mask perfectly the first time. Currently nothing on the market allows for an easy alignment to the face or ease of readjustment without having the remove the adhesive. Many people notice skin irritation when having to remove the adhesive many times in a short period due to application failure. Application error can also cause nasal occlusion, pressure points, and an overall discomfort. 
     SUMMARY OF THE INVENTION 
     Accordingly, as one aspect of the present invention a coupling arrangement for use in coupling a patient interface to the skin of a patient is provided. The coupling arrangement comprises: an adhesive arrangement comprising: a substrate material having a first surface and a second surface opposite the first surface, a first adhesive material provided on the first surface, and a second adhesive material provided on the second surface; and an application system disposed on the first adhesive material, the application system comprising: a number of separate portions, each portion formed from a film material and including: a base disposed on at least a portion of the first adhesive material, and a tab coupled to an interior edge of the base and extending upward and away therefrom, the tab being sized and configured to be grasped by the patient at an end portion opposite the interior edge. 
     For each separate portion, the base and the tab may be formed from a single unitary piece of the film material separated by a fold. 
     The number of separate portions may comprise a plurality of separate portions. 
     The adhesive arrangement may comprise a pair of apertures defined therein. 
     The adhesive arrangement may further comprise a layer of a release film provided covering the second adhesive material. 
     As another aspect of the present invention, an airway pressure support system for use in providing a flow of a breathing gas to the airway of a patient is provided. The pressure support system comprises: a patient interface structured to engage the face of the patient about the airway of the patient; and a coupling arrangement comprising and adhesive arrangement as described herein, wherein the second surface of the substrate material of the adhesive arrangement is coupled to a surface of the patient interface via the second adhesive material. 
     The patient interface may comprise a cradle-like nasal interface structured to engage the underside of the nose of the patient. 
     The surface of the patient interface may comprise a contoured surface, the patient interface may comprise a pair of nasal apertures defined in the contoured surface, the adhesive arrangement may comprise a pair of apertures defined therein, and each aperture of the adhesive arrangement may be aligned with a corresponding nasal aperture of the patient interface. 
     The airway pressure support system may further comprise: a gas flow generator that is structured to generate the flow of the breathing gas; and a hose having a first end coupled to the gas flow generator and an opposite second end coupled to the patient interface, wherein the hose is structured to convey the flow of the breathing gas from the gas flow generator to the patient interface. 
     As yet another aspect of the present invention, a method of coupling a patient interface to the skin of a patient via a coupling arrangement as described herein is provided. The method comprises: adhering the coupling arrangement to a surface of the patient interface via the second adhesive material; urging the patient interface assembly toward the skin of the patient such that each tab is compressed between the skin of the patient and the adhesive arrangement with each end portion of each tab extending outward from the patient interface; and pulling the end portion of the tab of one portion of the number of separate portions outward so as to expose a portion of the first adhesive material and adhering the skin of the patient thereto. 
     The method may further comprise: pulling the end portion of the tab of another portion of the number of separate portions outward so as to expose a another portion of the first adhesive material and adhering the skin of the patient thereto. 
     These and other objects, features, and characteristics of the present invention, 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. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. As 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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a simplified perspective front view of an airway pressure support system including a patient interface along with a coupling arrangement, in accordance with one non-limiting example embodiment of the present invention, shown with components thereof exploded; 
         FIG. 2  is a rear elevation view of the patient interface assembly of  FIG. 1  shown with the adhesive arrangement and application system of  FIG. 1  disposed thereon; 
         FIG. 3  is a top view of the arrangement of  FIG. 2  with the application system shown in dashed line so as to show the general relationship with the adhesive arrangement and patient interface assembly below; 
         FIG. 4  is an elevation section view of the arrangement of  FIGS. 2 and 3  taken along line  4 - 4  of  FIG. 3 ; 
         FIG. 5  is a top view, similar to that of  FIG. 3 , except showing (in dashed line) another application system in accordance with another one example embodiment of the present invention; and 
         FIGS. 6A-6C  show the arrangement of  FIGS. 1 and 4  positioned against the nose of a patient illustrating steps in securing the patient interface of  FIG. 1  to the nose of a patient using the application system. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     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. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. 
     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). 
     Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, 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. 
       FIG. 1  is a simplified perspective front view of an airway pressure support system  10  for use in providing a flow of a breathing gas to the airway of a patient (not shown). Airway pressure support system  10  includes a patient interface assembly  12  having a patient interface  14  and a coupling arrangement  16  (shown exploded) for use in coupling patient interface  14  to the face of the patient. Airway pressure support system  10  includes a gas flow generator  18  (shown schematically) and a hose  20  (partially shown schematically) having a first end (not numbered) coupled to gas flow generator  18  and an opposite second end (not numbered) coupled to patient interface  14 . Gas flow generator  18  is structured to generate a flow of breathing gas to be delivered to an airway of a patient via hose  20  and patient interface  14 . 
     In the example arrangement shown in  FIG. 1 , patient interface  14  is in the form of a cradle-like nasal interface for generally engaging the underside of the nose of a patient. Accordingly, patient interface  14  includes a pair nasal apertures  22  defined in a contoured surface  24 . In one example embodiment of the present invention, contoured surface  24  and each nasal aperture  22  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  14  may be employed without varying from the scope of the present invention. 
     Continuing to refer to  FIG. 1 , coupling arrangement  16  includes an adhesive arrangement  26  used for securing patient interface  14  to the face of a patient. Adhesive arrangement  26  is formed from a generally thin (e.g., having a thickness of at least 0.04 mm) substrate material  28  having a first surface  30 , which faces toward a patient (i.e., upward in  FIG. 1 ), and a second surface  32 , opposite first surface  30 , which faces toward patient interface  14  (i.e., downward in  FIG. 1 ). Planar substrate material  28  may generally be any pliable material such as, for example, without limitation, foam, silicone polyurethane, latex, or any other suitable material. Adhesive arrangement  26  further includes a first adhesive material  34  (shown schematically as hatching, e.g., without limitation, a silicone or acrylic based adhesive layer or any other suitable adhesive layer) provided on first surface  30  for use in adhering adhesive arrangement  26  to the skin of a patient. Similarly, adhesive arrangement  26  also includes a second adhesive material (not numbered) provided on second surface  32  for use in adhering adhesive arrangement  26  to contoured surface  24  of patient interface  14 , such as shown in  FIGS. 2-4, 5A-5C and 6 . 
     In order to provide for a reliable seal about each n are of the patient, and to allow for the passage of the flow of breathing gas from each of nasal apertures  22  of patient interface  14  to the respective nares of the patient, adhesive arrangement  26  includes a pair of apertures  40  defined therein of similar, and preferably identical shape (e.g., to minimize turbulence, maximize comfort, etc.), as nasal apertures  22 . 
     As discussed further below, in one example embodiment of the present invention adhesive arrangement  26  is a one-time use item that is used in securing patient interface  14  to the skin on the underside of the nose of a patient. As patient interface  14  is intended to be used multiple times, a new adhesive arrangement  26  would be adhered to patient interface  14  before each use. In such embodiment, adhesive arrangement  26  further include a layer of release film (not numbered) provided covering second adhesive material on second surface  32  for the second adhesive material until desired to be adhered to contoured surface  24  of patient interface  24 . 
     Continuing to refer to  FIG. 1 , as well as to  FIGS. 2-4 , coupling arrangement  16  further includes an application system  50  disposed on first adhesive material  34  of adhesive arrangement  26 . Application system  50  includes a number of separate portions  52 . In the one example embodiment shown in  FIGS. 1-4 , application system  50  includes two portions  52 , however, it is to be appreciated that the quantity of portions may be varied without varying from the scope of the present invention. For example,  FIG. 5  shows another patient interface assembly  12 ′ in accordance with one example embodiment of the present invention that is similar to the example shown in  FIGS. 1-4  except such embodiment utilizes an application system  50 ′ including four separate portions  52 ′. 
     Referring again to  FIGS. 1-4 , each portion  52  of application system  50  is formed separately from a suitable release film and is of similar design, hence only one portion  52  will be described in detail herein. Each portion  52  includes a base  54  and a tab  56 . Base  54  is sized and configured to be disposed covering at least a portion of first adhesive material  34  of adhesive arrangement  26 . Tab  56  is coupled to an edge of base  54  and extends upward and away from the base. In the example shown in  FIGS. 1-4 , tab  56  extends from an interior edge of base  54 . Tab  56  is sized and configured to be grasped by a patient, e.g., between a thumb and forefinger, at an end portion  57  opposite the interior edge as discussed below. In the one example shown in  FIGS. 1-4 , base  54  and tab  56  are formed as portions of a single unitary piece of material that have generally been delineated by a fold  58 , however, it is to be appreciated that base  54  and tab  56  may be formed separately and subsequently coupled without varying from the scope of the present invention. 
     Having thus described the general arrangement and components of one example patient interface assembly  12 , a method of coupling patient interface  14  thereof to a nose N of a patient using coupling arrangement  16  will now be discussed in conjunction with  FIGS. 6A-6C . In such views, coupling arrangement  16  was previously installed on patient interface  14  and adhered to contoured surface  24  thereof via the second adhesive (after removing the release film therefrom) of coupling arrangement  16 . Coupling arrangement  16  is aligned with patient interface  14  such that apertures  40  thereof are aligned with nasal apertures  22  of patient interface  14  (e.g., such as shown in  FIG. 3 ). One or more of tabs  56  of application system  50  may be utilized in gripping coupling arrangement  16  during such alignment and adhering to patient interface  14 . 
     Referring now to  FIG. 6A , patient interface assembly  12  is urged upward toward the underside of a patient&#39;s nose N such that each tab  56  is compressed between the underside of nose N and adhesive arrangement  26  with each end portion  57  of each tab  56  extending outward from nose N. Such positioning may be accomplished by the patient grasping patient interface  14  by applying forces such as indicated by arrows G, such as by grasping with the thumb and forefinger of the right hand of the patient. Patient interface  14  may readily be positioned by the patient with respect to nose N as portions  50  cover first adhesive  34  of adhesive arrangement  26 . 
     Referring now to  FIG. 6B , adherence of nose N to adhesive arrangement  16  via first adhesive  34  thereof begins by gripping end portion  57  of tab  56  of one of portions  52 , and pulling outward such as shown by each arrow P. Such gripping of end portion  57  may be carried out by the patient grasping with the thumb and forefinger of the left hand of the patient. As end portion  57  and thus tab  56  is pulled outward, base  54  is generally rolled/folded back onto itself, thus slowly exposing first adhesive  34  of adhesive arrangement  16  for adherence to the skin of the underside of nose N. As first adhesive  34  is slowly exposed, small adjustments of patient interface  14  relative to nose N may generally be made without discomfort to the patient or hampering the adherence of first adhesive  34 . 
     As shown in  FIG. 6C , once one portion  52  of alignment system  50  has been removed, half of the underside of nose N is adhered to patient interface  14  via first adhesive  34  of adhesive arrangement  26 . The other portion  52  is then removed in a similar manner to fully adhere patient interface  14  to the underside of nose N. 
     From the foregoing, it is thus to be appreciated embodiments of the present invention provide for alignment systems and coupling arrangements for use in coupling a patient interface to a patient that improve upon existing arrangements. 
     In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. 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. 
     Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.