Patent Publication Number: US-2019167464-A1

Title: Nasal dilator apparatus

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 62/118,473, filed Feb. 20, 2015, which is incorporated herein by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     This invention relates to the field of health. More specifically, this invention relates to apparatus and methods for reducing snoring and improving quality of sleep. 
     BACKGROUND 
     Unless otherwise indicated herein, the approaches described in this section are not prior art to the claims in this application and are not admitted to be prior art by inclusion in this section. Each reference cited herein is incorporated by reference herein in its entirety. 
     There are many reasons for breathing problems: swollen turbinates, interior scaring, age, accident, or surgery all can cause the alar cartilage to lose some of it firmness and stability. Perhaps even the wearing of glasses can contribute to this condition. The narrowest part of the nose, called the ostium internum, located behind the nostril flare—the ala, is also the location of the nasal air passages to the lungs. When the lateral wall of the vestibule (immediately inside the entrance to the nostril) in the area of the ostium internum loses its firmness, the tissue becomes loose and draws inward with each inhalation of breath, thus effectively blocking off the air supply. The reverse is true with each exhalation, where the tissue is expanded outward. 
     In an effort to improve the air supply, a person may adjust his or her head and/or body position many times during the night and is often aware of a slight awakening which prevents the deep sleep required for REM (Rapid Eye Movement), the dream state—the deepest state of sleep. Without this REM state of sleep, sleep deprivation follows, leading to chronic fatigue and a sense of being tired even upon waking in the morning, also known as sleep apnea. Many sleepers simply give up and resort to mouth breathing, which leads to a whole new set of problems, the least of which is not increased snoring and dry mouth. Long periods of mouth breathing can lead to dental problems and increased interruption of sleep. 
     The medical profession has addressed the problem by operating upon those with enlarged turbinates, swollen tonsils and adenoids, which does not always correct the condition. Some devices have been employed for aiding in opening the nasal passage, such as nasal inhaler devices and coils, however their utility and efficacy remain in question and no practical nasal insertion devices are readily available. 
     Thus, there remains a need for devices and methods for improving the quality of sleep, for example by increasing the volume of air flow through the nasal passage, and reducing snoring caused by blocked or semi-blocked nasal passages. 
     SUMMARY 
     In some embodiments, a removable nasal device (some embodiments referred to herein as a Nasal Aid or Ultimate Nasal Dilator) can be inserted into the nose before sleep in order to increase the volume of air flow into the lungs, thus improving the quality of sleep and to reduce snoring caused by lack of air which often results in mouth breathing. In some embodiments, a nasal device may be constructed of medical grade stainless steel wire, or any material which has similar tensile strength and hygienic quality, flexibility and malleability, and may be formed into a plurality of arches including a bridge arch configured and dimensioned to fit over the bridge of the user&#39;s nose, with two arches curving over the nasal vestibule and two loops that rest on the ostium internum, the loops, slightly elliptical, run alongside the end of each of the two sides. The device is meant to benefit those who suffer from restricted air flow into the nasal passages due to shape or condition of the interior nostril areas and their cartilage support system, including enlarged turbinates. The device can also be worn during periods of inactivity. 
     In an example embodiment, a nasal device is adapted for insertion into the vestibule of a user&#39;s nose to maintain the integrity of the nasal wall for providing unobstructed air passages into the lungs in order to improve the quality of breathing and to reduce snoring. The device may include an arched shaped device constructed of a malleable or semi-malleable material having a desired tensile strength to maintain its shape and provide a biasing force within the nose to hold back tissues and keep the nasal passage open. In some embodiments a device may include three arches, left and right sides, with each side ending in a loop or terminal member which is adapted to rest sideways of the nasal passage near the alar sidewalls, the narrowest part of the nasal passage and the site of air blockage due to infirm tissue which draws inward with each inhalation of breath thus blocking the passage and causing an insufficient air supply, snoring, mouth breathing and poor quality of sleep. In some embodiments, such apparatus may also include features for retaining the arched shaped unit in position in a wearer&#39;s nose with a snug fit down the length of the nasal bridge, past the rhinion over the nasal sill and into the nasal vestibule coming to rest on the inside of the alar sidewall, with the loops or other terminal members serving as paddles to maintain and restrain tissue away from nasal air passages, and having the tensile strength in the material to maintain the given shape 
     In some embodiments, terminal ends, e.g. configured as a paddle, blade or loop, may displace pressure from one point to all surfaces of said loops that come into contact with the nasal tissue, such construction being largely responsible for increasing a wearer&#39;s comfort and as an aid in maintaining placement of said device within a nose of a wearer. 
     In some embodiments, a nasal dilator device may be adjustable by the wearer for customizing for a particular nose by (a) widening or narrowing of the bridge arch spanning the nasal bridge the portion of the device that fits over the outside arch of the nose, (b) widening or closing the gap between said the arches that enter into the nasal vestibule, (c) widening or closing the gap between said nasal loops and the bridge frame, (d) slanting the loop arm inward or outward from the alar sidewall of the nose, and/or (e) increasing or decreasing depth of each loop by adjusting spaces between each said loop. 
     These as well as other aspects and advantages will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings. Further, it should be understood that the embodiments described in this overview and elsewhere are intended to be examples only and do not necessarily limit the scope of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a better understanding of the nature and objects of the invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings, in which: 
         FIG. 1  is a side view schematic illustration of a nose, showing anatomical features that may be helpful in describing use of various embodiments of nasal dilator apparatus herein. 
         FIG. 2  is a perspective view illustration of a nasal dilator apparatus in accordance with an example embodiment. 
         FIG. 3  is a side view of a nasal dilator apparatus of  FIG. 2  in use in a nose of a user in accordance with an example embodiment. 
         FIG. 4  is a front perspective view of a nasal dilator apparatus in accordance with another example embodiment. 
         FIG. 5  is a side perspective view of an example nasal dilator apparatus of  FIG. 4  in use in a nose of a user in accordance with an example embodiment. 
         FIG. 6  is a perspective view of another example nasal dilator apparatus that is adjustable in a vertical direction, in accordance with an example embodiment. 
         FIG. 7  is a perspective view example of another example nasal dilator apparatus that is adjustable in a horizontal direction, in accordance with an example embodiment. 
         FIG. 8  is a perspective view illustration of another example embodiment of a nasal dilator apparatus having closed loop terminal members. 
     
    
    
     DETAILED DESCRIPTION 
     I. Overview 
     Described herein are apparatus and methods for improving airflow through a user&#39;s nose during breathing. In the following description, for purposes of explanation, numerous examples and specific details are set forth in order to provide a thorough understanding of the aspects of the systems and methods. It will be evident, however, to one skilled in the art that the present invention as defined by the claims may include some or all of the features in these examples alone or in combination with other features described below, and may further include modifications and equivalents of the features and concepts described herein. 
     In some embodiments, an Ultimate Nasal Dilator apparatus is a removable device designed to be inserted into the nose to improve quality of breathing. This device may be used to increase air flow through the nasal passage to lungs by helping maintain the nasal wall integrity, thus preventing the nasal passage from collapsing. For example, when inserted into the nose, distal arms and terminal members may provide and outward biasing force against the interior of the nasal wall to help keep the nasal passage open to air flow. In some embodiments, nasal dilator apparatus described herein may provide relief from snoring caused by mouth breathing, e.g., resulting when the nasal passages are blocked. 
     In some embodiments, the shape of the Ultimate Nasal Dilator is designed to worn comfortably over the bridge of the nose, curve over the edge of the nose, and fit comfortably inside the nasal passage. The loops, or other terminal members, on either end of the device then press gently against the inside of the nasal wall to keep nasal passages open. 
     In some embodiments, the device is adjustable by narrowing or widening different portions or structural members of the apparatus, such as narrowing or widening the arch the fits over the bridge of the nose, narrowing or widening the gap between the curves that go over the edge of the nostril, opening or closing the gap between the end loops and the nasal bridge frame, or moving in or out the slant of the loops to accommodate the size of the nasal passage. 
     II. Example Embodiments 
     In the following detailed description, various embodiments are shown and described with reference to various anatomical features of a human nose. To aid in this discussion,  FIG. 1  is provided as a side view illustration of a human nose  10  with certain anatomical features shown, including the nasal bridge  12 , apex  30 , ala (or nostril flare)  20 , and naris (also referred to as the nostril)  40 . On the nasal bridge  12 , the area where bone meets cartilage (also described as the osseocartilaginous junction or the anterior tip of the median suture joining the nasal bones) is referred to herein as the rhinion  14 . Near the base of the nose sidewall  24  where it meets the ala  20 , is the alar crease  22 . The edge of the naris opening is sometimes referred to herein as the nasal sill  42 . 
     Each naris  40  or nostril provides an opening to the nasal cavity. The term “nasal passage” is also used herein to refer to the passageway or channel within the nasal cavity for air to flow through the nose. The area just inside each ala  20 , through the naris  40 , is sometimes referred to herein as the vestibule. Also, the area of the nasal passage just under the alar crease  22  and lower sidewall  24  is also sometimes referred to herein as “ostium internum”, which is sometimes described as the narrowest portion of the nasal passage and which in some people may loses its firmness or elasticity such that the nasal passage may draw inward with each inhalation of breath and restrict or block flow of air through the nasal passage to a user&#39;s lungs. Apparatus and methods described herein may be used to provide additional support to prevent airflow obstruction and maintain patency of the nasal passage. 
     Turning now to  FIG. 2 , a nasal dilator apparatus  200  according to one embodiment may be an elongated wire or other structure, e.g., constructed of stainless steel (e.g., medical grade stainless), other metals or metal alloys, plastic, Teflon, neoprene, nylon, polystyrene, PVC, or any combination there of. Apparatus  200  may include a nose bridge arch  210  configured to fit over the bridge of the nose and a pair of terminal members  250 ,  252 , e.g., loops, paddles, blades, or other terminal members configured and dimensioned to fit through each nostril and rest within the nasal passage of a user to press against an outer wall of the passage (e.g., in the area of the ostium internum). Each terminal member  250 ,  252  is connected to the nasal bridge by a nostril arm  240 ,  242 , a nostril arch  230 ,  232 , and a pair of bridge arms  220 ,  222  configured to fit on each side of the nose. 
     Referring to  FIG. 3 , a method  300  of using a nasal dilator device  200  is shown in a profile view of a nose  10 . Device  200  includes bridge arch  210  over bridge  12  of nose, with the left bridge arm  220  along the side of nose and next to the apex  30 . The nostril arch  230  is bent such that nostril arm  240  is directed through nostril  40 . Terminal member  250 , here shown as a loop, is inserted into the nasal cavity to press against the inner alar wall in the region of the ostium internum  312 . To insert the device  200 , bridge arms  220 ,  222  may be pinched slightly to provide inward displacement of arms  240 ,  242  and terminal members  250 ,  252  during insertion. When inserted and released, the bridge arms move back into position and provide a biasing force for terminal members  250 ,  252  against the interior tissues of the nose to maintain patency and airflow through nasal passage  310 . 
       FIG. 4  shows another embodiment of a nasal dilator device  400  according to an example embodiment. Like device  200 , device  400  may include a wire-shaped body having a bridge arch  410  connecting a pair of bridge arms  420 ,  422 , nostril arches  430 ,  432 , and nostril arms  440 ,  442 . Each arm  440 ,  442  may terminate in a terminal member  250 ,  252 , e.g., to provide a desired surface area and/or comfort when arms  440 ,  442  spread and press against the inner surface of the outer region of each ala. Additionally, one or more comfort tips  460 ,  462 , may be placed over each nostril arm  440 ,  442  and/or terminal member  250 ,  252  to provide further comfort when the nostril arms  440 ,  442  rest in the nasal passages. In some embodiments, tips  460 ,  462  may be silicone, neoprene, plastic, other elastomeric material, or some other desired material to provide optimal comfort and cleanliness. 
     Referring to  FIG. 5 , a method  500  of using a nasal dilator device  400  is shown in a perspective view of a nose  10 . Device  400  may include bridge arch  410  configured to fit snugly over bridge  12  of the nose, with the left bridge arm  420  along the side of nose and each side of the apex  30 . The nostril arch  430  is bent around the nasal sill such that nostril arm (not shown) is directed through the naris  40  and rests within the nasal passage. Comfort tip  460  is shown extending from the nasal cavity and pressing against the inner surface of the ala  41  wall. 
     Turning now to  FIGS. 6 and 7 , example embodiments of adjustable nasal dilator devices  600 ,  700  are shown. In some embodiments, a device  600  or  700  may have all of the features of device  400 , but also may include one or more adjustment assemblies, e.g., vertical adjustment assemblies  630 ,  640  ( FIG. 6 ) and/or horizontal adjustment assembly  720  ( FIG. 7 ). 
     For example, referring to  FIG. 6 , device  600  may be comprised of multiple main pieces that may be coupled and/or adjusted as desired, for example a bridge segment  610  and two nostril segments  620 ,  622 . In this example, the bridge segment  600  may include a bridge arch  410  as described above and one or more and one or more bridge arm segments  420 ,  422 . Left nostril segment  620  may include a bridge arm segment  420 ′ (which may be adapted to adjustably couple to segment  420 ), nostril arch  430 , arm  440  and terminal member  450 . Similarly, right nostril segment  622  may include a bridge arm segment  422 ′(which may be adapted to adjustably couple to segment  422 ), nostril arch  432 , arm  442  and terminal member  452 . Each vertical adjustment assembly  630 ,  640  may include features to adjustable couple the bridge segment  610  with each nostril segment  620 ,  622 , such that the lengths of arms  420 + 420 ′ and  422 + 422 ′ may be varied as desired for different size noses and/or fit preferences. In some embodiments, each adjustment assembly  630 ,  640  may include one or more vertical extending devices  632 ,  634  and  642 ,  644 , respectively configured to slideably or otherwise adjustably secure to each other at a desired length. In some embodiments, one or more connectors  633 ,  635  and  643 ,  645 , respectively, may be used to connect each extending device or coupler to the respective arm segment  420 ,  420 ′,  422 ,  422 ′. In some embodiments, corresponding extending devices  632 ,  634  may be similar in shape (e.g., cylindrical or other elongated shape) but with different diameters such that one device, (e.g.,  632 ) fits within the other, (e.g.,  634 ), for example such as a screw and elongated nut with corresponding threads. In other embodiments, other extending device shapes and/or coupling or extension mechanisms may be employed (e.g., using tabs, stops, ribs, or other features). 
     Referring to  FIG. 7 , a perspective view example of a nasal dilator apparatus  700  that is adjustable in a horizontal direction is shown. In this example, a horizontal extending assembly  720  is attached to the nose bridge arch region  410 . In such embodiments, two segments, e.g., a left segment  710  and a right segment  712 , may be adjustably coupled by the assembly  720 . As described above with respect to device  600  of  FIG. 6 , assembly  720  may include one or more horizontal extending devices  722 ,  724  that may be configured to engage each other. For example, each device  722 ,  724  may be elongated, cylindrical or oblong in shape, and may be dimensioned to fit together (e.g., using threads, tabs, stops, notches, or other desired features) and adjusted as desired for snugness and fit across the bridge of the user&#39;s nose. 
     Turning now to  FIG. 8 , another embodiment of a nasal dilator apparatus  800  is shown. In this embodiment, device  800  may be configured and dimensioned as a unibody structure constructed or comprised of any desired material or combination of materials, e.g. plastic, resin, PVC, Teflon, polystyrene, silicone, neoprene, nylon, or other desired material. In some embodiments, device  800  may be molded or formed as a uniform material. In other embodiments, device  800  may be comprised of any combination of materials and/or pieces, e.g., stainless steel or other core material coated with a resin, silicone, neoprene, plastic, Teflon, or other desired material. Similar to other embodiments described herein, device  800  may include a bridge arch  810  configured to fit over the bridge of a user&#39;s nose, arms  820 ,  822 , nostril arches  830 ,  832 , arms  840 ,  842 , and terminal members  850 ,  852 . In some embodiments, device  800  may be configured and dimensioned to have a desired rigidity to provide outward biasing force of terminal members  850 ,  852  and arms  840 ,  842  against the interior surfaces of nose to facilitate opening of nasal passages when inserted into the nose of a user. Biasing members  850 ,  852 , may be constructed and dimensioned to have a smooth outer surface for optimal comfort when in contact with the tissue membranes within the nose, e.g., using rounded edges, and may be configured in the shape of a paddle, blade, or other desired shape (e.g., with curved or concave dimensions to provide optimal comfort and minimal bulk to facilitate flow of air through the nasal passages. In some embodiments, portions of device body  800  that contact a user&#39;s skin, e.g., an inner surface of bridge arch  810  or bridge arms  820 ,  822  may be flattened or otherwise dimensioned to optimize comfort and minimize pressure points against the user&#39;s skin. 
     The foregoing description illustrates various embodiments of nasal dilator apparatus, along with examples of how aspects may be implemented. The above examples and embodiments should not be deemed to be the only embodiments, and are presented to illustrate the flexibility and advantages of the present invention. Based on the above disclosure and the following claims, other arrangements, embodiments, implementations and equivalents will be evident to those skilled in the art and may be employed without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.