Abstract:
A nasal dilator capable of introducing separating stresses in nasal outer wall tissues has a truss of a single body with a resilient member secured therein and a pair of spaced-apart end surfaces which, when forced toward one another from initial positions to substantially reduce direct spacing therebetween by a spacing reducing force external to said truss, results in restoring forces in the truss tending to return to the original direct spacing between the end surfaces. A resilient member, which is symmetrical with respect to a centerline of the truss that is perpendicular to the long axis of the truss, has a spring rate which continuously diminishes from the centerline to the end surfaces. An adhesive on the end surfaces adhesively engages exposed surfaces of nasal outer wall tissues sufficiently to keep the truss attached to the nasal wall surfaces while subjecting them to the restoring forces.

Description:
BACKGROUND OF THE INVENTION 
   This invention relates to an improvement to the design of a nasal dilator that is described in Spanish Patent No. 289,561 for Orthopaedic Adhesive granted to Miguel Angel Aviles Iriarti on 15 Sep. 1986. The Iriarti patent describes two designs of a nasal dilator. The first consists of a resilient band which has an adhesive on the bottom side and sufficient length so that when the center of the resilient band is bent over the bridge of the nose, each end is attached to the soft tissue on the lateral wall of the nasal passage. The adhesive can be applied as part of the back of the resilient band or applied directly to the skin prior to the application of the resilient band. 
   The second design described in the Iriarti patent shows a soft fabric cover with an adhesive on the bottom side which is larger than the resilient band. The resilient band is centered on the bottom of the soft fabric cover and attached to the adhesive. The center of the two-piece nasal dilator is bent over the bridge of the nose, and each end is attached to the soft tissue on the lateral wall of the nasal passage using the adhesive on the soft fabric cover that extends beyond the edge of the resilient band. 
   The mechanical forces generated by bending the resilient band from its initial planar state to its deformed state with the ends in contact with the lateral wall of the nasal passages result in forces tending to pull out on the lateral wall tissues which stabilize the walls of the nasal passages during breathing. The forces generated by the resilient band may be greater than the available strength of the adhesive which is located in the border of the soft fabric cover that extends beyond the resilient band as discussed in the second Iriarti design. One skilled in the art could combine the two Iriarti designs and add additional adhesive to the bottom of the resilient band which is attached to the bottom of the soft fabric cover and increase the ability of the nasal dilator to resist the mechanical forces generated by the resilient band. 
   The present invention is an improvement to the nasal dilator design disclosed in the Iriarti patent because it has a resilient band which has a variable spring rate that decreases from the point where the resilient band crosses the bridge of the nose to the point where the resilient band terminates at the lateral wall of the nasal passage. 
   The present invention also has a concave indent on one side of the dilator and a convex protrusion on the opposite side of the dilator at the center of the bridge of the nose to indicate to the user the proper orientation of the dilator when it is in use. 
   Another improvement to the Iriarti design is the use of a soft fabric cushion with adhesive on both sides to prevent the resilient band from coming in contact with the user&#39;s skin. This soft fabric cushion is the same size as the top soft fabric cover. 
   Blockage of the nasal passages from swelling due to allergies, colds and physical deformities can lead to breathing difficulty and discomfort. The nasal passages have mucus membranes which condition the air in the nasal passages prior to its arrival in the lungs. If the nasal passages are constricted due to swelling or minor deformities then the alternative is to breathe through the mouth. This means that the air bypasses the mucus membranes, losing the conditioning effects and causing irritation in the throat and lungs. At night, restrictions to breathing through the nasal passages can lead to snoring and/or sleep disturbances. In some cases, the restricted air supply can cause sleep problems brought on by a lack of oxygen. 
   For people with chronic blockages in the nasal passages, the alternative to correct the problem has been expensive surgery or medication. People with minor deformities and breathing problems brought on by swelling of the walls of the nasal passageways have been turning to various products fitted in or on the nose which claim to open the nasal passages. 
   The structure of the nose limits the options available for the design of nasal dilators. The nose terminates at the nostril, which has a slightly expanded volume immediately above it known as the vestibule. Above the vestibule, the nasal passage becomes restricted at a point called the nasal valve. At the nasal valve, the external wall of the nose consists of soft skin known as the lateral wall, which will deform with air pressure changes induced within the nasal passage during the breathing cycles. Above the nasal valve the nasal passage opens up to a cavity with turbinates over the top of the palate and turns downward to join the passage from the mouth to the throat. 
   The external structure of the nose consists of a skin covering over the nasal bones which are part of the skull. This gives the top of the nose a rigid structure at its base. Beyond the rigid nose bones, there is thin cartilage under the skin which is attached to the septum, which in turn contributes to the outside shape of the nose. The septum forms the wall between the two nostrils and may, if it is crooked, contribute to breathing problems. 
   As an alternative to surgery, the structure of the nose and the current art leave two alternatives for the design of nasal dilators. One alternative is the type of dilator that consists of some type of tube or structure which can be inserted into the nasal passage to hold it in the open position allowing the free passage of air. The disadvantage to this design is that the dilator structure covers up the mucus membranes which condition the air. Also dilators of this design are uncomfortable and can irritate the walls of the nasal passage. 
   The second alternative is a dilator design as taught by Iriarti where each end that attaches to the external lateral wall of each of the nasal passages has some type of resilient means connecting the ends for developing an external pulling force on the lateral wall causing it to open the nasal passage. This design has the advantage over the first alternative because the nasal passages are not disturbed by an internal insert. This design has limited control over the resilient force on the lateral wall of each of the nasal passages, and the resilient members crossing over the bridge of the nose can cause discomfort. 
   The present invention is an improvement over the Iriarti design because it redistributes the lifting forces within the resilient band by modifying the spring rate, so that they can provide optimum lift on the lateral walls of the nasal passage and maximum comfort to the user. 
   The prior art that comes closest to the present invention is nasal dilators with some means for adjusting the spring rate of the resilient band in the nasal dilator. The first is U.S. Pat. No. 5,476,091 to Johnson, which shows two parallel resilient bands of constant width and constant thickness which cross over the bridge of the nose and terminate at the outer wall of each nasal passage. The Johnson patent shows a plurality of notches cut into the top of each end of the resilient band to reduce the spring rate, which in turn prevents the end of the resilient band from peeling away from the skin. Each notch is a single point reduction of the spring rate with the spring rate reduction determined by the depth of the notch. 
   The second U.S. Pat. No. 5,479,944 to Petruson and the third U.S. Pat. No. Re 35,408 to Petruson cover the same nasal dilator design. In these patents, the nasal dilator is a one-piece molded plastic strip, the ends of which carry tabs for insertion into the nostrils. 
   The fourth U.S. Pat. No. 5,611,333 to Johnson shows the same concept of single point reduction in the spring rate of the resilient band using the notches shown in U.S. Pat. No. 5,476,091 mentioned above. In addition this patent shows other designs for the resilient band with either holes or slots which are located at the ends of the resilient bands and are designed to reduce the spring rate at a single point to prevent the end of the resilient band from peeling away from the skin. 
   The fifth U.S. Pat. No. 6,029,658 to Voss shows a beam-shaped resilient band which extends from one side of the user&#39;s nose across the bridge of the nose to the other side of the nose. The resilient band is made of plastic and has a varying thickness and width over the entire span. The resilient band exhibits a rigidity increase from the center towards the two respective ends which attach to the sides of the user&#39;s nose, which is the exact opposite of what is attained with the present invention. 
   The sixth U.S. Pat. No. 6,453,901 to Ierulli shows several nasal strip designs where the cover member extends beyond the perimeter of the spring member, including one embodiment in which the strip has some degree of variation in the spring force over a portion of the length of the strip. 
   There are many other patents describing nasal dilator designs, but none of them teach the advantage of using a resilient band with a means for varying the spring rate to improve the performance of the nasal dilator or reduce the peel forces at the ends of the strip. 
   SUMMARY OF THE INVENTION 
   The object of this invention is to provide a nasal dilator which exhibits improved performance relative to the nasal dilator described in the Spanish Patent No. 289,561 for Orthopaedic Adhesive granted to Iriarti. The Iriarti patent shows two nasal dilator designs. The first design consists of a resilient band with adhesive on the bottom side which crosses over the bridge of the nose and has two ends each of which terminates at the lateral walls of the nasal passages. The resilient band pulls out the lateral walls as it attempts to return to its natural planar state. 
   The second design consists of a soft fabric cover with adhesive on the bottom side which is larger than the resilient band. The resilient band is attached to the adhesive in the center of the bottom of the soft fabric cover. The dilator assembly is centered on the bridge of the nose, and the ends are each bent until they are in contact with the lateral walls of the nasal passages. The surface of the soft fabric cover that extends beyond the borders of the resilient band has the adhesive which holds the dilator on the skin of the nose. As in the first design, the resilient band pulls out the lateral walls as it attempts to return to its natural planar state. 
   Combining the two Iriarti designs for a nasal dilator improves the performance of the dilator, because greater adhesive surface is available to hold the dilator in place on the user&#39;s nose and overcome the stresses contained in the resilient band. The improvements to the Iriarti design which are part of this invention are intended to further improve the performance and comfort of the dilator. 
   An improvement to the Iriarti dilator that is according to the present invention is a change in the configuration of the resilient band to reduce the width gradually from the center of the resilient band towards each end in a way that gradually reduces the spring rate of the resilient band. The thickness of the resilient band remains constant over its entire length, which simplifies the structure while keeping costs low. 
   Another improvement provided by the present invention is the provision of a concave indent on one side of the dilator and a convex protrusion on the opposite side of the dilator at the center of the dilator where it crosses the bridge of the user&#39;s nose. The indent and protrusion assist the user in properly orienting the dilator so it can be properly positioned on the user&#39;s nose for optimum performance. 
   Another improvement of the present invention, particularly over the Iriarti dilator, is the addition of a bottom soft fabric cover which is of the same size and shape as the top soft fabric cover and has adhesive on both sides. The bottom soft fabric cover prevents the resilient band from contacting the user&#39;s skin, so the resilient band is in contact with the adhesive on the top surface while the adhesive on the bottom surface of the bottom soft fabric cover attaches the dilator to the skin on the user&#39;s nose. 
   Another improvement of the present invention is the use of transparent materials for the top soft fabric cover, the resilient band, and the bottom fabric cover. The normal color for the top soft fabric cover is tan; however, for sports applications the cover may be black or some other dark color. 
   The improvements summarized above enhance the performance of the dilator and make the dilator more comfortable for the user as compared to prior art dilators in general and the Iriarti dilator in particular. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The unique advantages of the present invention will become apparent to one skilled in the art upon reading the following specification and by reference to the following drawings: 
       FIG. 1  is a side view of the dilator on the nose; 
       FIG. 2  is an exploded perspective top view of the components making up the dilator; 
       FIG. 3  is a side view of the dilator on the nose with the asymmetrical resilient band sloped toward the nostril; 
       FIG. 4  is a side view of the dilator on the nose with the asymmetrical resilient band sloped away from the nostril; and 
       FIG. 5  is a drawing showing the force vectors of the dilator in this invention compared to the force vectors in the Iriarti dilator. 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   The specific improvements provided by this invention over the nasal dilator design described in Spanish Patent No. 289,561 to Iriarti are best seen in the attached drawings. 
     FIG. 1  shows the new nasal dilator  10  mounted on the nose  70  of the user. The nasal dilator  10  is designed so that the center  11  of the nasal dilator  10  is bent over the bridge  71  of the nose  70  and each end  12  and  13  of the nasal dilator  10  is positioned over the lateral wall  72  of the nose  70 . 
   The lateral wall  72  of the nasal passage  75  is located in the soft tissue  73  above the nostril flare  74 , which in turn is adjacent to the entrance of the nasal passage  75 . When the nasal dilator  10  which contains a resilient band  30  is deformed from its normally planar state by being bent over the bridge  71  of the nose  70 , the ends  12  and  13  which are attached to the lateral wall  72  of the nasal passage  75  tend to pull on the lateral wall  72  in a way that opens the nasal passage  75  and improves the air flow through the nasal passages  75  during breathing. The Iriarti patent describes two designs of a nasal dilator which can perform the function of dilating the lateral walls  72  of the nasal passages  75 . 
   This invention shows improvements to the Iriarti nasal dilator design that improve the performance of the nasal dilator  10 , make the nasal dilator  10  easier to use, and improve the comfort of the nasal dilator  10  when it is in use on the user&#39;s nose  70 . 
   Referring to  FIG. 2 , the nasal dilator  10  is made up of several layers. The first layer is the top cover  20  which is made from a non-woven polyester fabric or equal which is usually tan in color on the top surface  21 . The top surface  21  of the top cover  20  can be dyed in any color or imprinted with a brand logo. The top cover  20  also has a bottom surface  22  which is coated with a 3 mils acrylic hypoallergenic medical grade pressure-sensitive type adhesive  25  or equal. The adhesive  25  covers the entire bottom surface  22  of the top cover  20 . 
   The top cover  20  has two parallel sides  23  and  24  which run over the length of the top cover  20  with the exception of a 0.5-inch wide section at the center  11  of the dilator  10 . On one side  23  of the top cover  20 , there is a convex protrusion  26  which is designed to indicate the proper orientation of the strip when it is in use. On the opposite side  24  of the top cover  20 , there is a concave indent  27  that matches the shape of the convex protrusion  26 , so that over the entire span of the top cover  20 , the width measured across adjacent points on sides  23  and  24  is constant. 
   The second layer is the resilient band  30 , a plastic layer, which is made from a clear polyester sheet which is about 0.010 inch to 0.015 inch thick, depending on the required strength of the nasal dilator  10 . The thickness selected of the resilient band  30  is constant over the entire length of the resilient band  30 , so the nasal dilator  10  can be manufactured in a converting process. The width of the resilient band  30  is greatest at the center  31  where the nasal dilator  10  passes over the bridge of the nose  71 . The two sides  32  and  33  of the resilient band  30  curve towards each other as the distance from the center  31  of the resilient band  30  is increased. This reduction of the width of the resilient band  30  causes a reduction of the spring rate in the resilient band  30  over the span from the center  31  to each of the ends  34  and  35  of the resilient band  30 . The width at the center  31  of the resilient band  30  is less than half of the width of the top cover  20 , and the width of the resilient band  30  at each of the ends  34  and  35  is approximately half of the width of the center  31 . 
   In a preferred embodiment, the sides  32  and  33  of the resilient band  30  between the center  31  and the respective ends  34  and  35  are curved over the length of the strip and preferably symmetrical in relation to the longitudinal center line  36  of the resilient band  30 . Other curves for sides  32  and  33  are possible as long as the maximum width of the resilient band  30  is at the center  31  and the spring rate is reduced as the distance from the center  31  is increased until reaching ends  34  and  35 . To attain the desired force distribution, the radius of curvature of the sides  32  and  33  of the resilient band  30  is greater than 1.5 inches. In addition, the thickness of the resilient band  30  is 3% or greater than the width of the resilient band at the longitudinal center line  36 . This ratio increases as the distance from the center  31  is increased, and the width of the resilient band decreases until reaching ends  34  and  35 . 
   The third layer is the cushion layer  40  which is designed to prevent direct contact between the resilient band  30  and the skin of the user. The cushion layer  40  is the same shape as the top cover  20  and is made from woven polyester or equal. The cushion layer  40  has a top surface  41  which has a 1.5 mils acrylic hypoallergenic medical grade adhesive  42  and a bottom surface  43  which has a 3.0 mils acrylic hypoallergenic medical grade adhesive  44 . 
   The cushion layer  40  has two parallel sides  45  and  46  which match the two parallel sides  23  and  24  of the top cover  20 . The cushion layer  40  also has a convex protrusion  47  and a concave indent  48  which match the convex protrusion  26  and concave indent  27  of the top cover  20 . 
   The fourth layer of the nasal dilator  10  is a release liner  50 . The release liner  50  covers the adhesive  44  on the bottom surface of the cushion layer  40  until the nasal dilator  10  is ready for use. The release liner  50  has sufficient surface area to hold one or more nasal dilators  10 . The sides  23  and  24  of the top cover  20  are designed to be mirror images of each other. This allows a single cut of the converting machine to separate adjacent nasal dilators  10  so the release liner  50  sheet may have from four to six nasal dilators  10  on a single sheet. This maximizes the efficiency of the converting manufacturing process. 
   The nasal dilator  10  is a truss assembly  15  which includes the top cover  20  which has the resilient band  30  attached at the center of the bottom surface  22  by the adhesive  25 . The bottom surface  22  extends beyond the edges of the resilient band  30  so the cushion layer  40  with its adhesive  42  on the top surface  41  can be laminated to the bottom side  37  of the resilient band  30  and to the bottom surface  22  of the top cover  20  which extends beyond the sides  32  and  33  of the resilient band  30 . 
   The nasal dilator  10  truss assembly  15  is normally in a planar state when it is removed from the release liner  50  and has no stresses. When the nasal dilator  10  is bent over the bridge  71  of the nose  70  and the ends  12  and  13  are engaged with the lateral wall  72  of the nasal passage, then the stresses introduced in the resilient band  30  of the truss assembly  15  cause the ends  12  and  13  of the nasal dilator  10  to pull outwardly on the lateral wall  72  to improve the breathing of the user. 
   The nasal dilator  10  can also be provided as a clear nasal dilator  10 . In this design the top cover  20  is made from a 3 mil polyethylene with the bottom surface  22  coated with 2 mils acrylic hypoallergenic medical grade adhesive  25 . The resilient band  30  is made from the clear polyester used in the tan nasal dilator  10  and the cushion layer  40  is made from 3 mil polyethylene with both the top surface  41  and the bottom surface  42  coated with 2 mils acrylic hypoallergenic medical grade adhesive  41  and  42 . 
     FIGS. 3 and 4  show another embodiment of the resilient band  30  which is part of the nasal dilator  10 . In  FIG. 2 , the resilient band  30  is symmetrical to the longitudinal centerline  36  of the resilient band  30 . This is achieved by using identical curves for sides  32  and  33  between the center  31  and the ends  34  and  35  of the resilient band  30 . In  FIGS. 3 and 4 , the sides  32  and  33  have different curves and are not symmetrical with respect to the longitudinal centerline  36  of the resilient band  30 . The concept of using a reduction of the width in the resilient band  30  that causes a reduction of the spring rate in the resilient band  30  can be used in nasal dilator  10  with one or more parallel resilient bands that extend parallel to the longitudinal center line  36  of the nasal dilator  10 . 
   The use of a resilient band  30  with a decreasing spring rate in a nasal dilator has a positive effect on the nasal dilator performance.  FIG. 5  shows a comparison of the performance of a nasal dilator  10  with a decreasing spring rate  60  on the left side of the vertical centerline  55  and a nasal dilator  10  with a constant spring rate  80  on the right side of the vertical centerline  55 . The nasal dilator  10  is shown bent over an elliptical surface  56  which represents the skin  76  of the user&#39;s nose  70 . 
   The nasal dilator  10  with the decreasing spring rate  60  has a series of vectors  61  pulling out on the elliptical surface  56 . Vectors  61  which are further away from the vertical centerline  55  increase to vector  63 . Then they begin to decrease to vector  64  at the end  12  of the nasal dilator  10 . The vectors  61  on the side with the decreasing spring rate  60  cause the lateral wall  72  to be pulled up and out at the center of the nasal passage  75 , which improves the air flow in the nasal passage  75 . A reactive vector  65  provides an opposing force to vectors  61 . 
   On the side with a nasal dilator  10  with a constant spring rate  80  there are a series of vectors  81  pulling out on the elliptical surface  56 . As the vectors  81  move away from the vertical centerline  55 , they increase until the last vector  83 . This means that the pull on the lateral wall  72  is outward and that the maximum vector  83  is pulling out on the lateral wall  72  at the edge of the nasal passage  75 . Although air flow is improved, the nasal dilator  10  with the decreasing spring rate  60  provides better performance because it opens the lateral wall  72  adjacent to the center of the nasal passage  75  where the maximum air volume flows. Also the reactive vector  85  is greater than the reactive vector  65  for the decreasing spring rate  60  nasal dilator  10 , which renders the constant spring rate  80  nasal dilator  10  is less comfortable for the user. 
   The description of the preferred embodiment described herein is not intended to limit the scope of the invention, which is properly set out in the claims.