Abstract:
Nasal dilators comprise tubes having a length to width ratio of no more than unity. The tubes are right cylinders which are shown in circular, oblong and radiused cornered rectangular forms. One or more tabs can extend from the outer end of the tube, a rim may extend outwardly about the periphery of the inner end of the tube and a septum may diametrically bisect the hole within the tube. Dilator kits provide variable outside diameters for accommodating differences in nose structure. A member extending between two such tubes can be employed to provide a set for both nasal passages of the nose.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    The field of invention is nasal dilation.  
           [0002]    Snoring affects 45% of the population from time to time and an estimated 25% snore habitually. Snoring can also contribute to obstructive sleep apnea syndrome. OSAS, consists of frequent interruption of breathing during sleep, owing to intermittent collapse of the upper airway. Untreated, sleep apnea can cause high blood pressure and other cardiovascular disease, memory problems, weight gain, impotency, and headaches. Moreover, untreated sleep apnea may be responsible for job impairment and motor vehicle crashes. Most recently, studies have been conducted leading to evidence that “Sudden Infant Death Syndrome” may actually be caused by sleep apnea. Personal relationships are often damaged by partners snoring. Athletes can greatly improve performance by increased nasal breathing. Many can benefit by an improved nasal dilator.  
           [0003]    There are basically three different types of nasal dilators employed over the years to help unblock nasal passages allowing air to pass more freely. External nasal dilators usually consist of an adhesive backed spring pad designed to be applied across the outside of the nose.  
           [0004]    The other two types are internal insert nasal dilators designed to be placed inside the nasal cavity. The internal insert devices can further be classified into two basic types of design. Wire form types consist primarily of interconnected mesh forms or spring bars designed with the purpose of expanding the nasal canal wherever contacted by the form members. The wire form spring bar devices potentially have a disadvantage. The tissue inside the nasal canal is very delicate and sensitive. Any individual bar member contacting this delicate tissue with sufficient force to free the entire airway passage can potentially cause discomfort.  
           [0005]    Tubular form types differ from the other types of nasal dilators in that the contacting wall surface inside the nasal cavity is contiguous. The entire surface area of the nasal canal is expanded by the contact area of the tube device. Pressure to expand the delicate nasal tissue is more evenly distributed by the uniform contact area derived by the contiguous wall of the tube. U.S. Pat. Nos. 1,256,188; 2,335,936; 2,569,743; 2,672,138; 5,665,104 and Des. 388,172 all teach variations of the internal insert tubular nasal dilator and show length to width ratios exceeding unity dictating potentially disadvantageous application.  
           [0006]    Certain of the tubular form types are applied by being inserted deeply into the nasal cavity so that the bottom of the tube is basically flush with the bottom opening of the nostril. The human nose structure, illustrated in FIG. 1, around the immediate nostril opening is surrounded by the septum, intermediate crus, sesamoid cartilage and lower lateral cartilage-lateral crus. This area is generally elastic and fleshy with the exception of the lower lateral cartilage above the opening of the nostril. The lower lateral cartilage is connected only to the fleshy membrane around it. It is not connected directly to the rigid cartilage members above that give the rhinion area of the outer nose it&#39;s distinctive shape.  
           [0007]    Above the lower lateral cartilage is the upper lateral cartilage separated only by the intranasal suture line connected to the rigid nasal bone above. Any tubular nasal dilator device designed to be inserted deeply enough to potentially affect the upper lateral cartilage has a different function. It is this area where many individuals suffer a collapse of the generally narrowing airway. However, it is this area that is also most sensitive to manipulation by an external device protruding within. Many individuals have a deviated septum or other anomaly that affects sensitivity to this area. It can be painful to have this area manipulated by direct force expansion.  
           [0008]    Such elongate devices may not be inserted so deeply as to physically engage the upper lateral cartilage. Such tubes as illustrated in the prior art are of a length to width ratio to substantially protrude below the lower nostril area if not placed so deeply. It was found through testing that any tube device, or connecting members such as tie straps, that protrudes substantially below the nostril area can easily be dislodged or repositioned during sleep.  
           [0009]    It is common during sleep to touch the face or affect the nose area with contact of the pillow during sleep movement. A device that protrudes substantially below the lower nostril area can potentially be dangerous. Sleep movement can be violent at times when sleep is troubled. It is possible to hit this area of the nose with sufficient force to drive the dilator further up the nasal canal than intended. This can cause pain and potentially damage. There is also an increased potential for damage if the worn device protrudes substantially below the nostril during sports activities.  
         SUMMARY OF THE INVENTION  
         [0010]    The present invention is directed to internal nasal dilation. Tubes having a length to width ratio of no more than 1 are placed in the nose.  
           [0011]    In a first separate aspect of the present invention, the tube includes a rim at one end about the periphery of the tube. This rim is outwardly extending to assist in opening the nasal passage.  
           [0012]    In a second separate aspect of the present invention, the tube includes a differential and compressive stress to strain ratio angularly about the cylindrical tube. Rotation of the tube then can result in increased spreading of the nasal passage after insertion of the tube. The angular differential may be provided by a septum extending diametrically across the tube.  
           [0013]    In a third separate aspect of the present invention, the tube includes a differential in effective width in a nasal passage angularly about the cylindrical tube. Such differential can be provided by the tube being a noncircular cylinder such as an oblong cylinder or a radiused cornered rectangular cylinder. Again, rotation of the tube provides the differential width after placement within the nasal passage.  
           [0014]    In a fourth separate aspect of the present invention, a nasal dilator kit of such tubes which are in substantially identical sets and varying across the normal range of nasal passage diameters includes intermediate tubes to provide proper fit within each nasal passage.  
           [0015]    In a fifth separate aspect of the present invention, a process of nasal dilation includes selecting the appropriate sized tube and inserting that tube in the nasal passage not to extend into the passage to adjacent the upper lateral cartilage and not to extend substantially from the end of the nasal passage. Rotation of the tube to achieve further opening of the nasal passage may be additionally employed once the tube is appropriately inserted.  
           [0016]    In a sixth separate aspect of the present invention, any of the foregoing aspects are contemplated to be employed in combination to further advantage. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]    [0017]FIG. 1 is a diagrammatic representation of a nose.  
         [0018]    [0018]FIG. 2 is a perspective view of a nasal dilator.  
         [0019]    [0019]FIG. 3 is a nose with the nasal dilator of FIG. 2 illustrated in perspective.  
         [0020]    [0020]FIG. 4 is a perspective view of a nasal dilator kit.  
         [0021]    [0021]FIG. 5 is a perspective view of a second embodiment of a nasal dilator.  
         [0022]    [0022]FIG. 6 is a perspective view of a third embodiment of a nasal dilator.  
         [0023]    [0023]FIG. 7 is a perspective view of a fourth embodiment of a nasal dilator.  
         [0024]    [0024]FIG. 8 is a perspective view of a fifth embodiment of a nasal dilator.  
         [0025]    [0025]FIG. 9 is a perspective view of a sixth embodiment of a nasal dilator.  
         [0026]    [0026]FIG. 10 is a front view of a nose with the nasal dilator of FIG. 9 placed therein.  
         [0027]    [0027]FIG. 11 is a perspective view of a seventh embodiment of a nasal dilator.  
         [0028]    [0028]FIG. 12 is a perspective view of an eighth embodiment of a nasal dilator.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0029]    Turning in detail to the drawings, FIG. 1 illustrates a nose in a schematic view. Of relevance here is the upper lateral cartilage  10 , the lower lateral cartridge  12  and the nasal passage  14 .  
         [0030]    [0030]FIG. 2 illustrates a minimal nasal dilator tube  16 . The tube  16  has an outside dimension sized to be snugly received by normal nasal passages  14 . The tube  16  might range from 0.375 inches o.d. to 0.75 inches o.d. for adults and 0.125 inches o.d. to 0.500 inches o.d. for children. The height of the tube  16  is such that the length to width ratio of the tube  16  does not exceed unity. The tube  16  is illustrated in place in a nose  18  in FIG. 3.  
         [0031]    The tube  16  is made of a flexible elastomeric material. The thermal plastic elastomer family of plastics are appropriate for this use. Santoprene® manufactured by Advanced Elastomer Systems is one such elastomer that is nonhygroscopic as well as suitable for medical device applications. However, there are many other elastomerics suitable for use as the integral tube  16  such as natural rubbers, synthetic rubbers, thermoform elastomerics, thermoset elastomerics and combination blended materials.  
         [0032]    The tube  16  is flexible with rounded edges to aid in placement and to avoid irritation in place. The tube  16  of FIG. 2 is shown to be a right circular cylinder. The wall thickness of the tube is preferably between 0.010 inches and 0.100 inches. The material of the tube  16  is preferably resilient at the foregoing thicknesses such that it will regain its shape even though it may be collapsed for insertion into the nasal passages  
         [0033]    The relationship of the length to width of the tube  16  allows it to be positioned in a normal nose without extending into the nasal passage  14  so far as to be adjacent the upper lateral cartilage  10 . At the same time, the tube  16  does not extend substantially from the nasal passage  14 . Such placement is illustrated in FIG. 3. The tube  16  expands the region within which it is positioned in the nasal passage  14 . The lower lateral cartilage  12  is able to move such that pressure on the delicate areas of the upper nasal passage will not be impacted by compression between the tube  16  and the lower lateral cartilage  12 . Such would not be the case if the tube  16  extended into adjacent the upper lateral cartilage  10 . Consequently, the ratio of length to width of the tube  16  being equal to or less than unity avoids the difficulties associated with insertion into adjacent the upper lateral cartilage  10 .  
         [0034]    At the same time, the placement of the tube  16  in the lower lateral area of the nostril cavity and its expansion of the soft tissue surrounding also acts to draw the soft tissue adjacent to the upper lateral cartilage  10  forwardly and outwardly to open up the nasal passage adjacent to the upper lateral cartilage  10 , beyond where the tube  16  extends. Thus, a clear passage is created in the nasal passage  14  both adjacent the lower lateral cartilage  12  through the hole  20  in the nasal dilator tube  16  and past the upper lateral cartilage  10  through the influence of the tube  16  on the soft tissue in that area.  
         [0035]    The length of the tube  16  also provides for the tube not extending substantially from the end of the nasal passage  14 . This is advantageous because there is a tendency for the bedding or human contact to engage or otherwise interfere with tubing which extends from the nose. This can result in dislodging the tube from the nose or injuring the nasal soft tissue if abruptly impacted.  
         [0036]    [0036]FIG. 4 illustrates a set of nasal dilators retained within a container  22 . Dilators  16  are arranged as two sets for general retail sales. When offered as a kit in two sets, the tubes  16  are arranged in graduating size diameters in the appropriate range depending on application for the individual. Again, a practical kit for adults would include outside dimensions of tubes  16  of about 0.375 inches to 0.75 inches. The increments may be anywhere between 0.010 inches and 0.125 inches. With that range, a minimum of two tubes per set in two sets would be included within the container  22 . The other embodiments addressed below could also be accommodated by the same or similar container  22 .  
         [0037]    [0037]FIG. 5 illustrates one variation on the tube  16  of FIG. 2. In the embodiment of FIG. 5, a right circular cylindrical tube  24  is shown to include a hole  26  therethrough and tabs  28 . These one or more tabs  28  would extend outwardly of the nasal passage to a small extent for easy manual purchase for insertion and removal.  
         [0038]    [0038]FIG. 6 illustrates yet another embodiment also employing a right circular cylindrical tube  30  with a hole  32  therethrough. A rim  34  extends outwardly about the periphery of the tube  30  at one end thereof. The tube  30  is intended to be placed in the nasal passage  14  with the rim  34  at the inside top edge. The soft tissue within the nasal passage  14  accommodates this rim  34 , creating a impermanent set which helps retain the tube  30  in place. The rim  34  also increases the pressure a bit to further draw soft tissue adjacent the upper lateral cartilage  10  to promote opening of the nasal passage  
         [0039]    [0039]FIG. 7 illustrates yet another embodiment with a nasal dilator tube  36  having a hole  38  therethrough. The tube  36  is again shown to be a right circular cylinder with a length to width ratio of no more than unity. A tube septum  40  extends diametrically across the hole  38  and is integrally formed with the tube  36 . This septum  40  provides a differential compressive stress to strain ratio angularly about the tube  36 . Compressing the tube parallel to the septum tube  40  is more difficult than compressing the tube perpendicularly to the septum  40 . Thus, a maximum stress to strain ratio is experienced in alignment with the septum  40  while a minimum stress to strain ratio is perpendicular thereto.  
         [0040]    The foregoing contemplates the tube septum  40  being sufficiently rigid to exhibit column strength. If the septum  40  is thin, the maximum stress to strain ratio may be accomplished at 90° to the tube septum  40  instead where the septum  40  acts in tension. This property may be thought of also as a differential effective width as the user perceives that the nasal dilator  36  is wider or narrower depending on its orientation given the stress to strain ratios.  
         [0041]    Employment of the embodiment of FIG. 7 provides for insertion of the tube  36  into longitudinal position within the nasal passage  14 . Rotation of the nasal dilator  36  then provides for increased soft tissue distortion in whichever way a greater opening requirement is desired, typically with the maximum resistance to compression being oriented laterally within the nose.  
         [0042]    [0042]FIG. 8 illustrates a variation on the embodiment of FIG. 7. In FIG. 8, a septum  42  extends across the hole  44  of a nasal dilator tube  46 . Again, the tube  46  is a right circular cylinder. A rim  48  as in the embodiment of FIG. 6 is also employed. The outside surface of the tube  46  includes longitudinally extending splines  50 . These splines  50  provide surface height variations, in this instance, to resist rotation by helping to seat the device within the surrounding soft tissue. Bumps, grids and other variations or patterns may be employed instead. In addition to the splines  50 , the septum  42  has an extended length exceeding the tube to form a protruding tab  52 . This tab  52  extends from one end of the dilator  46 . This tab  52  makes it more convenient to rotate, insert or retract the dilator relative to the nasal passage  14 . Again, the main body of the tube  46  has a height to width ratio of no greater than unity. By locating the tab  52  centrally at one end of the tube septum  42 , manual acquisition is easier without interference of the rim with the nasal passage  14 .  
         [0043]    [0043]FIG. 9 illustrates a member  54  extending between two tubes  56  as configured in FIG. 2. FIG. 10 illustrates the placement of the device of FIG. 9 in a nose. The member  54  is integrally formed with the two tubes  56  and is preferably quite flexible to admit of variation in the sizes and shapes of the nasal septum.  
         [0044]    [0044]FIG. 11 illustrates a nasal dilator which is defined by a right oblong cylindrical tube  58  having a hole  60  and a tab  62 . This oblong tube  58  has a differential effective width to provide a similar effect provided by the septum  40  in the embodiment of FIG. 7. A similar effect is provided by the nasal dilator of FIG. 12 having a tube  64  which is a radiused cornered rectangular cylinder having a hole  66  and a tab  68 . This device of FIG. 12 provides some advantage in the rotation of the cylinder about its axis to change the effective width as placed in the nasal passage. The squared-off sides can act to stabilize the angular orientation of the dilator when one or more of the four sides is pressed against a substantially flat side of the nasal passage  14 .  
         [0045]    Thus, improved nasal dilators and methods for their use are disclosed. While embodiments and applications of this invention have been shown and described, it would be apparent to those skilled in the art that many more modifications are possible without departing from the inventive concepts herein. The invention, therefore is not to be restricted except in the spirit of the appended claims.