Abstract:
An appliance adapted to engage and expand nasal passages of a nose and prevent their collapse is disclosed. The appliance includes angularly oriented first and second legs having distal ends insertable into the nasal passageways. A bridge member connects proximal ends of the legs to one another. Third and fourth legs are connected to the first and second legs and have distal ends that engage opposite outer surfaces of the nose. The first and second legs are adjustable in both the coronal and sagittal planes to accommodate noses of various sizes and shapes. Porous substrates and soluble compounds may be attached to the first and second legs and deliver medicaments or other compounds. A method of expanding the nasal passageways by inserting and biasing the appliance into the nose is also disclosed.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     This application is a continuation-in-part of U.S. application Ser. No. 11/297,136, filed Dec. 8, 2005, which claims priority to U.S. Provisional Patent Application No. 60/634,395, filed Dec. 8, 2004. Both the aforementioned parent application and the provisional application are hereby incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The invention concerns a medical appliance insertable into the nasal passages to improve breathing and treat snoring disorders.  
       BACKGROUND OF THE INVENTION  
       [0003]     The American Academy of Sleep Medicine estimates that 40 to 60 million people suffer from chronic snoring. Snoring is the noise produced during sleep when soft tissue at the back of the nose and throat vibrate. The vibration is induced by the turbulent flow of air through narrowed air passages. Snoring may be an indication of potentially serious medical problems and constitutes a source of annoyance to those in the vicinity of the snorer. The degree to which snoring is considered a problem is evidenced by the number of different surgical procedures, such as somnoplasty, tonsillectomy, and the surgical removal of adenoids or obstructing tissue, developed for its treatment.  
         [0004]     Mechanical appliances have been developed as an alternative to surgical treatment of snoring. The nasal passages are, in part, defined by relatively soft cartilaginous tissue, and the interior constitutes a mucous membrane. The relatively soft tissue is prone to collapse under ambient pressure when reduced pressure is present within the nasal passages, as occurs during respiration. The tissue is also sensitive and readily irritated by foreign objects such as appliances inserted to maintain patency of the nasal passages. The presence of the mucous membrane means that the nasal passages can provide a gateway for infection as well as a path for the introduction of medicaments. These factors must be addressed by any device or appliance designed to be inserted into the nasal passages to treat snoring.  
       SUMMARY OF THE INVENTION  
       [0005]     The invention concerns an appliance adapted to engage and expand the nasal passages of a nose and prevent collapse thereof upon inhalation of air therethrough. The appliance comprises first and second legs arranged in spaced apart relation substantially co-planar with one another. The first and second legs are oriented angularly to one another. Each of the first and second legs have a proximal end, and a distal end insertable within a respective nasal passage. The distal ends are spaced farther apart than the proximal ends for biasing the nasal passages outwardly into an open configuration. A bridge member connects the proximal ends of the first and second legs to one another. Third and fourth legs are arranged in spaced apart relation substantially co-planar with one another. The third and fourth legs each having a proximal end attached to the proximal end of a respective one of the first and second legs, and a distal end engageable with an outer surface of the nose for holding the appliance thereon.  
         [0006]     Preferably, the first and second legs each comprise a pair of segments connected to one another by a reverse bend positioned at their respective distal ends. Each segment of each pair is adjustably movable toward and away from one another for establishing a separation distance therebetween, the segments engaging and expanding the nasal passages upon insertion of the device therein. Each of the segment pairs are preferably located in respective sagittal planes relatively to the nose.  
         [0007]     The second and third legs each have a loop positioned at their respective distal ends. The loops engage the outer surface of the nose on opposite sides thereof. Preferably, the bridge member comprises a loop positioned between the first and second legs, the loop providing angular adjustability between the first and second legs.  
         [0008]     The distal ends of the legs are coated with a polymer coating. Alternately, or in addition to the polymer coating, a porous substrate may be attached to the distal end of at least one of the first and second legs, the substrate adapted to contain a substance for release into the nasal passages. The substrate may comprise, for example, an aromatic compound or a medicament. In another embodiment, a soluble membrane may be attached to the distal end of at least one of the first and second legs. The soluble membrane is adapted to contain a substance for release into the nasal passages.  
         [0009]     The invention also encompasses a method of expanding the nasal passages of a nose into an open configuration. The method comprises:  
         [0010]     (a) inserting a distal end of a first and a second leg into respective nasal passages;  
         [0011]     (b) biasing the distal ends of the first and second legs outwardly away from one another, each leg thereby engaging a sidewall of the respective nasal passages;  
         [0012]     (c) engaging a distal end of a third and a fourth leg with respective outer surfaces of the nose on opposite sides thereof; and  
         [0013]     (d) biasing the distal ends of the third and fourth legs inwardly against the respective outer surfaces.  
         [0014]     The method may also include:  
         [0015]     (a) forming the first and second legs from respective pairs of segments;  
         [0016]     (b) orienting the segments of each pair in respective sagittal planes relatively to the nose; and  
         [0017]     (c) biasing the segments away from one another in the respective sagittal planes, the segments engaging and expanding the nasal passages in the respective sagittal planes. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0018]      FIG. 1  is a top view of an embodiment of a nasal appliance according to the invention;  
         [0019]      FIG. 2  is a side view of the nasal appliance shown in  FIG. 1 ;  
         [0020]      FIG. 3  is a cross sectional view of the nasal appliance taken at line  3 - 3  of  FIG. 1 ;  
         [0021]      FIG. 4  illustrates the nasal appliance shown in  FIG. 1  in use; and  
         [0022]      FIGS. 5 and 6  show top views of alternate embodiments of the nasal appliance according to the invention. 
     
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS  
       [0023]      FIG. 1  illustrates a nasal appliance  10  according to the invention. Nasal appliance  10  comprises first and second legs  12  and  14  arranged in spaced apart relation. The first and second legs are substantially co-planar as shown in  FIG. 2 , and are preferably formed by pairs of segments  16  and  18  and  20  and  22  (see  FIG. 3 ). The segments  16  and  18  comprising leg  12  are joined to one another by a reverse bend  24  at the distal end  26  of leg  12 . The segments  20  and  22  are joined to one another by another reverse bend  28 , also at the distal end  30  of the leg  14 . As shown in  FIGS. 1 and 2 , the legs  12  and  14  have respective proximal ends  32  and  34 . Preferably, the distal ends  26  and  30  of the first and second legs  12  and  14  are spaced wider apart than the proximate ends of these legs, providing an angular orientation between the first and second legs.  
         [0024]     The proximal ends of legs  12  and  14  are connected to one another by a bridge element  36 . As best shown in  FIG. 1 , the bridge element  36  comprises a loop  38  that provides flexibility and resilience to the legs  12  and  14 , allowing their relative angular position to be adjusted to accommodate a nasal passage as described below.  
         [0025]     Third and fourth legs  40  and  42  are attached, respectively, to the proximal ends  32  and  34  of the first and second legs  12  and  14 . The third and fourth legs are also arranged angularly with respect to one another and are substantially co-planar, as shown in  FIG. 2 . The plane of the third and fourth legs is preferably displaced from the plane of the first and second legs, thereby providing a geometry that best fits a nose as described in detail below. The respective distal ends  44  and  46  of the third and fourth legs  40  and  42  project inwardly so as to engage opposite sides of the nose as illustrated in  FIG. 4 . Preferably, loops  48  and  50  (see especially  FIGS. 1 and 2 ) are positioned respectively at the distal ends of the third and fourth legs  40  and  42 . The loops enlarge the engagement area between the third and fourth legs and the outside of the nose, thereby mitigating the potential for irritation. The loops may have any shape, for example, round as shown, oval or polygonal.  
         [0026]     Appliance  10  is preferably formed integrally from FDA approved surgical grade stainless steel wire having a diameter between about 0.030 and 0.036 inches. Stainless steel is preferred because it is radiopaque, will not corrode and is compatible with living tissue. Surgical grade wire, as used in orthodontic work, provides a material with great flexibility and resilience, allowing the appliance to be repeatedly bent and adjusted in shape for comfort of the user and effectiveness in supporting and expanding the nasal passageways. The aforementioned diameter range has been found to provide excellent fatigue life and adequate stiffness to support and expand the cartilaginous tissue of the nose.  
         [0027]     For comfort and safety, the appliance  10  is formed with rounded bends of generous radii; sharp points or edges that might irritate or cut nasal tissue, especially the sensitive internal lining of the nasal passageways, are avoided. Further protection to the user is provided by coating at least those portions of the appliance that contact the nose with a polymer coating  52 . The coating  52  is positioned on the distal ends of legs  12 ,  14 ,  44  and  46  and preferably comprises polyvinylchloride resin. Polyvinylchloride is preferred because it is flexible, hypo-allergenic, color fast, chemically inert, and able to withstand high temperatures thereby allowing the device to be sterilized in an autoclave. This polymer also provides a smooth surface with few irregularities where bacteria or viruses can accumulate. These characteristics provide a sanitary appliance that will not irritate or infect the mucous membrane of the nasal passageways when used properly. The coating  52  may be applied by dipping the legs into a molten bath of the polymer and then allowing it to cure. Coating thicknesses of not less than 0.030 inches per side (0.060 inches total) are preferred. Other polymers are also feasible, for example, resins such as methylmethacrylate.  
         [0028]     In use, as illustrated in  FIG. 4 , the distal ends  26  and  30  of the first and second legs  12  and  14  are inserted into the nasal passageways  54  and  56 , and the distal ends  44  and  46  of the third and fourth legs  40  and  42  are engaged with the outer surfaces  58  and  60  on opposite sides of nose  62 . The appliance  10  displays a distinct “W” shape in plan view. This shape is advantageous because it supports and expands the nasal passages  54  and  56  outwardly without impinging on and irritating the nasal septum. The resilience and flexibility of the surgical steel coupled with the preferred diameter of the wire forming the appliance allows the device to be bent and adjusted so as to control the angular orientation of the legs  12  and  14  to bias the nasal passageways outwardly sufficiently to prevent snoring, yet comfortably. The loop  38  of bridge element  36  allows for excellent adjustability and resilience of the legs  12  and  14 , and acts as a spring to bias the legs outwardly against the cartilaginous tissue. The third and fourth legs  40  and  42  are in a different plane from the first and second legs (see  FIG. 2 ) so as to adapt to the geometry of the nose  62 . These legs are also angularly oriented, and biased inwardly so that loops  48  and  50  engage the nose surfaces  58  and  60  firmly yet comfortably to reliably retain the appliance in the nose and prevent it from being aspirated accidentally. Reverse bends  41  and  43  are used to attach the legs  40  and  42  respectively to the legs  12  and  14 . The reverse bends  41  and  43  permit angular adjustment of the third and fourth legs  40  and  42  independently of the first and second legs to ensure proper engagement of the loops  48  and  50  with the nose. The legs  40  and  42  are also of a size and orientation such as to make accidental ingesting or swallowing of the appliance very difficult. In the unlikely event that this happens, the radiopaque nature of the device will allow easy detection by X-ray techniques.  
         [0029]     While the “W” shape and bridge loop  38  allow for substantial lateral adjustment of the appliance (toward and away from the nasal septum), adjustment in the fore and aft directions (parallel to the nasal septum) is also provided by constructing legs  12  and  14  from segment pairs  16  and  18  and  20  and  22  as best shown in  FIG. 2 . As noted above, each segment pair is located in a respective sagittal plane  64  and  66  (see also  FIG. 1 ). The reverse bends  24  and  28  of the legs allow the segments to be separated or narrowed in their respective sagittal planes to expand and support the nasal passageways in the direction parallel to the nasal septum as required for comfort and breathing efficiency. Thus, the appliance provides the ability to expand the nasal passageways in two mutually perpendicular directions to ensure proper breathing and prevent snoring. The infinite adjustability of the appliance, the curved ends and loops of the legs, and the absence of sharp points and edges allows it to be adapted comfortably and safely to any nose size.  
         [0030]     In addition to treatment of snoring, the appliance  10  according to the invention may be used, for example, to aid in breathing when the nose has suffered trauma and is healing, such as post surgery or after an injury. Other forms of treatment can also be realized with minor modifications to the appliance.  
         [0031]     As shown in  FIG. 5 , a porous substrate  68  may be attached to one or both of the legs  12  and  14 . The substrate may be impregnated with a substance, such as an aromatic compound or a medicament. When an aromatic compound is used, the appliance  10  is an effective delivery device for aroma therapy. Aromatic compounds smelling like chocolate, coffee and other pleasant fragrances are feasible. Medicaments such as antihistamines, vitamin B12 for the treatment of anemia, calcium for the treatment of osteoporosis, anti-asthma compounds, medications for treatment of diabetes and mentholated ointments may be delivered by the substrates  68  of the appliance. In another embodiment, shown in  FIG. 6 , the legs  12  and  14  may be coated with soluble membrane  70 , such as ethyl acetate cellulose. The membrane may be the vehicle for a medicament, which is absorbed into the bloodstream through the mucous membrane of the nose as the membrane dissolves when the appliance is inserted into the nasal passageways.  
         [0032]     Nasal appliances according to the invention provide a safe, comfortable and effective device for treatment of snoring as well as other disorders.