Abstract:
A spring-biased nasal molding device for presurgical molding of cleft lip deformities, the device having a V-shaped spring member joined to a pair of intra-nasal shaping members for insertion in a nostril, and having an extra-nasal shaping member to be positioned external to the nostril connected to each intra-nasal shaping member, wherein the intra-nasal and extra-nasal shaping members are brought together by the spring member to mold the nasal anatomy into the desired shape.

Description:
BACKGROUND OF THE INVENTION 
     This invention relates generally to the field of orthopedic appliances used to presurgically ameliorate congenital cleft lip deformities in infants by the application of direct controlled molding forces, such appliances often referred to as nasoalveolar molding (NAM) appliances, as well as to methods of correcting cleft lips using such NAM appliances. 
     A key component of the cleft lip deformity is nasal asymmetry and abnormal form. Current surgical techniques can achieve limited correction. Pre-surgical nasal molding has become popular in large cleft centers in an attempt to minimize the nasal deformity prior to surgery. Unlike adult cartilage, the nasal cartilages of an infant are responsive to external molding pressures and will permanently change shape. The most common pre-surgical treatment (nasoalveolar molding) now in use is limited to linear molding changes on the nostrils, and requires an oral splint for stabilization of the nasal molding component. The traditional NAM treatment protocol requires weekly visits to the orthodontist over the first three months of life of the infant for progressive manual adjustment of the NAM device to alter the molding forces on the infant&#39;s alveolus and nasal anatomy. The traditional NAM device relies on taping across the base of the nose to achieve medial movement of the lateral crura and alar bases, and a separate pressure post based on an acrylic oral splint to fit inside the nostril and lift the nasal tip. Limitations of this existing technique are that the taping force is extremely variable in achieving the desired result, can distort the upper lip, and since the upward force is more powerful than the taping, an enlarged, iatrogenic triangulated nostril deformity can result. 
     Improved methodologies and nasal molding devices are disclosed in U.S. Pat. No. 8,323,308 to Hopper and U.S. Pat. No. 8,523,896 to Hopper, in which a dynamic NAM device is disclosed. The device in a main embodiment comprises a pair of rotation assemblies each having an internal shaping member for insertion in a nostril and an external shaping member to be positioned externally to the nostril, wherein the internal and external shaping members are progressively incrementally pivoted about the rotation assemblies, while simultaneously the separation distance between the rotation assemblies is incrementally decreased by reducing the angular separation about a centralized assembly, thereby molding the nasal anatomy into the desired shape over time. The device requires mechanisms to lock the angular positioning of the centralized assembly and the rotational positioning of the external/internal shaping members. Furthermore, the device requires multiple manual adjustments over the course of time. 
     It is an object of this invention to provide a device and a method that addresses the problems encountered in the known devices and methods for presurgical molding and shaping of anatomical members distorted or improperly formed due to the presence of a cleft lip. It is a further object to provide a spring-biased nasal molding device that imparts a three-dimensional rotational change in nasal morphology in preparation for corrective surgery, which device is self-retaining and self-supporting due to opposing tension across the nose, to rotate the lateral crura and alar crease of the lower lateral cartilages of the nose medially and superiorly, while simultaneously elevating the genu and soft triangle of the nasal tip superiorly, with the simultaneous, coordinated and progressive rotational molding of the nostril width and height precluding nasal aperture distortion or enlargement. It is a further object to provide such a device that automatically and continuously provides the shaping force without need for manual adjustment after placement in the nasal anatomical members. 
     SUMMARY OF THE INVENTION 
     A spring-biased nasal molding device is presented that is an orthopedic appliance adapted for automatically and continuously shaping and molding the cartilage, tissues, etc. of the nose, upper mouth, gums and upper lip of infants having unilateral or bilateral cleft lips in order to promote symmetry and proper morphology of these anatomical features prior to the corrective surgical procedures used to close the cleft. The nasal molding device is self-supporting and self-retaining on the patient. The nasal molding device is easily sized and oriented relative to each patient. 
     The nasal molding device comprises in general a V-shaped spring member, a pair of intra-nasal shaping members connected to the spring member, and a pair of extra-nasal shaping members connected to the intra-nasal shaping members. In use the spring-biased nasal molding device is applied to the patient with the intra-nasal shaping members inserted internally into the nostrils and with the extra-nasal shaping members positioned bilaterally externally to the nostrils along the alar crease between the nasal and cheek units. 
     In differing embodiments of the invention, the spring member may for example comprise a helical torsion spring or a V-spring bridging the main housing members of the intra-nasal shaping members. A spool-like core member may be positioned within the coiled portion of the helical torsion spring, with bridging segments of the spring extending to the intra-nasal shaping members. The intra-nasal shaping member may comprise an elongated projecting post which retains a cushioned cover member. The extra-nasal shaping members may comprise an L-shaped arm member on which is mounted a cushioned cover member. The L-shaped arm member may comprise the end segments of the spring member extending through the housing members of the intra-nasal shaping members, and the spring member may be coiled about a spool-like internal mounting member disposed in each of the intra-nasal housing members. 
     With this structure, a properly sized nasal molding device is chosen, the device possessing the desired final separation distance between the intra-nasal shaping members and also possessing the desired spring strength to apply the correct amount of force to the nasal structures. The intra-nasal shaping members are then spread apart by the medical practitioner and placed onto the patient such that the intra-nasal member are inserted into the nostrils and the extra-nasal members are positioned externally to the nostrils. The relationship of the intra-nasal and extra-nasal shaping members in combination with biasing force of the spring member serves to retain the device on the patient without need for additional affixation and serves over time to mold and reposition the anatomical features into the desired configuration. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of an embodiment of the invention utilizing a helical torsion spring. 
         FIG. 2  is a side view of the embodiment of  FIG. 1 . 
         FIG. 3  is a partial side view of the embodiment of  FIG. 1 , shown in partial cross-section and with the cover members shown partially separated from the extra-nasal arm member and the intra-nasal projecting post. 
         FIG. 4  is a rear view of the embodiment of  FIG. 1 . 
         FIG. 5  is a front view of the embodiment of  FIG. 1 . 
         FIG. 6  illustrates an alternative embodiment of the invention utilizing a V-spring. 
         FIG. 7  illustrates an alternative embodiment for the intra-nasal cover member. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     With reference to the drawings, the spring-biased nasal molding device or appliance will now be described in detail with regard for the best mode and preferred embodiment or embodiments, along with its method of use in correcting cleft lips. In general, the nasal molding device is an orthopedic appliance structured and adapted for shaping and molding the cartilage, tissues, etc. of the nose, upper mouth, gums and upper lip of infants having unilateral or bilateral cleft lips in order to promote symmetry and proper morphology of these anatomical features prior to the corrective surgical procedures used to close the cleft. The nasal molding device is self-supporting and self-retaining on the patient, such that the need for adhesive tape or elastic members to maintain the device on the patient is obviated or greatly minimized. The nasal molding device is easily sized and oriented relative to each patient, and the device applies continuous pressure during the corrective process. 
     The nasal molding device comprises in a most general sense a centralized spring member  10 , a pair of intra-nasal or shaping members  20  connected to the spring member  10 , and a pair of extra-nasal shaping members  30  connected to the intra-nasal shaping members  20 . In use the nasal molding device is applied to the patient with the intra-nasal shaping members  20  inserted into the nostrils and with the extra-nasal shaping members  30  positioned bilaterally along the alar crease between the nasal and cheek units. 
     The spring member  10  is a V-shaped biasing mechanism that pulls the intra-nasal shaping members  20  toward each other, preferably over an arced pathway. The spring member  10  may comprise for example a helical torsion spring or a V-spring. The embodiment shown in FIGS.  1 ,  2 ,  4  and  5  comprises a helical torsion spring  12  having a coil segment  15  and a pair of bridging segments  16  extending radially outward from the central axis of the coil segment  15  to form a V-shaped configuration, each bridging segment  16  being attached to an intra-nasal shaping member  20 . In a preferred embodiment, a core member  11  may be disposed within the coiled segment  15  of the helical torsion spring  12 , and the core member  11  may comprise a cylindrical body  13  with a pair of radially extending rim members  14 , such that the core member  11  is spool-shaped. 
     Alternatively, spring member  10  may comprise a V-spring  18  formed of wire or flat bar, the V-spring  18  oriented in an inverted position such that the angle of the “V” points upward when the device is utilized on a patient and such that the ends of the “V” are attached to the intra-nasal shaping members  20 , as shown in  FIG. 6 . 
     Two intra-nasal shaping members  20  are connected to spring member  10  so as to extend rearward and into the nostril cavity when the device is applied to the patient. The intra-nasal shaping members  20  are adapted to have contact with the nasal lining directly on the undersurface of the lower lateral cartilages from the top of the ascending limb, along the genu to the lateral crus, but to have minimal contact with the alar rim. The intra-nasal shaping members  20  each comprise a generally rigid projecting post  22  on which is mounted a cover member  23  preferably composed of a compressible or less rigid material such as a silicone or similar polymer. The cover members  23  are preferably removable, as illustrated in  FIG. 3  and may be of differing thicknesses or configurations to better size the internal shaping member  20  to the patient and to provide a desired lifting and molding surface, as shown in  FIG. 7 , where the cover member  23  is provided with a lateral molding member  29 . This lateral molding member  29  is oriented to the side when the extra-nasal shaping members  30  are rotated inwards, but as the molding force rotates the extra-nasal shaping members  30  outwards (i.e. counterclockwise for the left extra-nasal shaping member  30  and clockwise for the right extra-nasal shaping member  30 ) the lateral molding members  29  rotate upward to lift the nostrils. In a typical procedure, three embodiments of the cover member  23  will be utilized—one with no lateral molding member  29 , one with a small lateral molding member  29  and the other with a large lateral molding member  29 . In a preferred embodiment shown in  FIGS. 1 through 5 , the intra-nasal shaping member  20  comprises a main housing  21  of greater diameter than the projecting post  22 . 
     An extra-nasal shaping member  30  is mounted onto each intra-nasal member  20  in a manner whereby the extra-nasal shaping members  30  are positioned outwardly or laterally to said intra-nasal shaping members  20 , and such that the extra-nasal shaping members  30  and the intra-nasal shaping members  20  are substantially in parallel, as shown in  FIGS. 4 and 5 . Each extra-nasal shaping member  30  is positioned so as to contact the skin of the alar crease at the lateral aspect of the nose and thus provide opposing contact to the lateral crus contact of the intra-nasal shaping member  20 . The extra-nasal shaping member  30  is mounted to the intra-nasal shaping member  20  by an arm member  31 , which may be L-shaped such that a short portion of the arm member  31  extends laterally from the intra-nasal shaping member  20  and a longer portion extends rearward to form the main body of the extra-nasal shaping member  30 . A cover member  32  may be provided on the arm member  31 , the cover member  32  preferably being composed of a compressible or less rigid material such as a silicone or similar polymer. The cover members  32  are preferably removable, as illustrated in  FIG. 3  and may be of differing thicknesses or configurations to better size the extra-nasal shaping member  30  to the patient. The arm member  31  may be provided with a retaining knob  33  and the cover member  32  may be provided with a cushioning head  34 , as shown in  FIG. 3 . 
     The spring member  10  may be affixed directly to the exterior or interior of each main housing  21 , and in a preferred embodiment the main housing  21  comprises a tubular portion  25 , the bridging segments  16  of helical torsion spring  12  extending through slots  26  into the interior of the tubular portion  25 . The bridging segment  16  is then coiled around an internal mounting member  24 . The arm members  31  connecting the extra-nasal shaping members  30  to the intra-nasal shaping members  20  may be externally or internally connected to the intra-nasal shaping members  20 , and may be rigid, spring-like or malleable. In a preferred embodiment shown best in  FIG. 3 , the helical torsion spring  12  is extended outwardly from each intra-nasal shaping member  20  through a slot  26  such that arm members  31  are formed from a portion of the helical torsion spring  12 . The slots  26  must be of sufficient width circumferentially to allow the intra-nasal shaping members  20  to rotate independently of any central widening. 
     The intra-nasal shaping members  20  and the extra-nasal shaping members  30  are sized and configured so as to occupy a relatively small volume within the nasal cavity to minimize interference with breathing. The initial positioning of the extra-nasal shaping members  30  relative to the intra-nasal shaping members  20  is determined by the anatomy of the patient and whether a single or bilateral deformity is presented, and may be adjusted by bending the arm members  31 . To utilize the device, the spring member  10  is manually flexed by spreading apart the intra-nasal shaping members  20 , thereby loading spring member  10 . The intra-nasal shaping members  20  are then inserted into the nostrils and the extra-nasal members  30  are positioned externally to the nostrils. The biasing force of the spring member  10  then imparts a continuous force pulling the intra-nasal shaping members  20 , the extra-nasal shaping members  30  and the patient&#39;s anatomical features together along an arced pathway in the corrective direction, which serves over time to mold and reposition the anatomical features into the desired configuration for further medical procedures. 
     It is contemplated that certain equivalents or substations for elements set forth above may be obvious to those of ordinary skill in the art, and therefore the true scope and definition of the invention is to be as set forth in the following claims.