Abstract:
A spring-biased nasal molding device for presurgical molding of cleft lip deformities, the device having a pair of intra-nasal shaping members for insertion into the nostrils and having an extra-nasal shaping member to be positioned external to the nostrils 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 
       [0001]    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. 
         [0002]    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 pemanently 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. 
         [0003]    Improved methodologies and nasal molding devices are disclosed in U.S. Pat. No. 9,486,353 to Hopper, 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. It is a further object to provide such a device wherein the shaping force is produced by a unitary biasing member composed of a polymer material and comprising a spring segment, a pair of intra-nasal projecting members and a pair of extra-nasal arm members, with the device further comprising a cover member disposed on each of the extra-nasal arm members and a stent member disposed on each of the intra-nasal projecting members. 
       SUMMARY OF THE INVENTION 
       [0004]    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. 
         [0005]    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. 
         [0006]    The invention is a nasal molding device adapted for pre-surgical molding of cleft lip deformities in a patient, said device comprising a biasing member, preferably a unitary biasing member, composed of a polymer material and comprising a U-shaped central spring segment, a pair of tubular intra-nasal projecting members and a pair of extra-nasal arm members, wherein said intra-nasal projecting members are connected to said central spring segment and said extra-nasal arm members are connected to said intra-nasal projecting members; a cover member disposed on each of said extra-nasal arm members, the combination of said cover members and said extra-nasal arm members defining a pair of extra-nasal shaping assemblies; a tubular stent member disposed on each of said intra-nasal projecting members, each of said stent members comprising a rounded, radially-projecting body, the combination of said stent members and said intra-nasal projecting members defining a pair of intra-nasal shaping assemblies; wherein said intra-nasal projecting members each comprise a base portion and an elongated post portion, and wherein said extra-nasal arm members are connected to said base portions of said intra-nasal projecting members; said unitary biasing member further comprising a pair of helical spring members, wherein said intra-nasal projecting members are connected to said central spring segment by said helical spring members, each of said base portions of said intra-nasal projecting members comprising a cavity, and said helical spring members being received within said cavities of said base portions of said intra-nasal projecting members; wherein said intra-nasal shaping assemblies are adapted to be positioned in the nostrils of the patient having a cleft lip deformity and said extra-nasal shaping assemblies are adapted to be positioned along the alar creases of the patient, such that the tissue of the patient is retained between the intra-nasal shaping assemblies and the extra-nasal shaping assemblies, and whereby said intra-nasal shaping assemblies are separable by manually flexing said spring segment, and whereby upon release said spring segment brings said intra-nasal shaping assemblies together over an arced pathway. 
         [0007]    With this structure, a properly sized nasal molding device is chosen, the device possessing the desired final separation distance between the intra-nasal shaping assemblies and also possessing the desired spring strength to apply the correct amount of force to the nasal structures. The intra-nasal shaping assemblies 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 assemblies 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. 
         [0008]    Alternatively, the invention may be described and defined as a nasal molding device adapted for pre-surgical molding of cleft lip deformities in a patient, said device comprising a biasing member composed of a polymer material and comprising a central spring segment, a pair of intra-nasal projecting members and a pair of extra-nasal arm members, wherein said intra-nasal projecting members are connected to said central spring segment and said extra-nasal arm members are connected to said intra-nasal projecting members; a cover member disposed on each of said extra-nasal arm members, the combination of said cover members and said extra-nasal aim members defining a pair of extra-nasal shaping assemblies; a stent member disposed on each of said intra-nasal projecting members, the combination of said stent members and said intra-nasal projecting members defining a pair of intra-nasal shaping assemblies; wherein said intra-nasal shaping assemblies are adapted to be positioned in the nostrils of the patient having a cleft lip deformity and said extra-nasal shaping assemblies are adapted to be positioned along the alar creases of the patient, such that the tissue of the patient is retained between the intra-nasal shaping assemblies and the extra-nasal shaping assemblies, and whereby said intra-nasal shaping assemblies are separable by manually flexing said spring segment, and whereby upon release said spring segment brings said intra-nasal shaping assemblies together over an arced pathway. Still further, such a device wherein said central spring member is U-shaped; wherein said intra-nasal projecting members are tubular and each comprise a base portion and an elongated post portion; wherein said intra-nasal projecting members each further comprise a retention member; wherein each of said stent members is tubular and comprises a radially-projecting body; wherein said radially-projecting bodies are rounded; wherein said radially-projecting bodies are rounded; said unitary biasing member further comprising a pair of helical spring members, wherein said intra-nasal projecting members are connected to said central spring segment by said helical spring members; and/or each of said base portions of said intra-nasal projecting members comprising a cavity, and said helical spring members being received within said cavities of said base portions of said intra-nasal projecting members. 
         [0009]    Alternatively summarized, the invention is a nasal molding device adapted for pre-surgical molding of cleft lip deformities in a patient, said device comprising: a unitary biasing member composed of a polymer material and comprising a U-shaped central spring segment, a pair of tubular intra-nasal projecting members and a pair of extra-nasal aim members, wherein said intra-nasal projecting members are connected to said central spring segment and said extra-nasal arm members are connected to said intra-nasal projecting members; a cover member disposed on each of said extra-nasal arm members, the combination of said cover members and said extra-nasal arm members defining a pair of extra-nasal shaping assemblies; a tubular stent member disposed on each of said intra-nasal projecting members, the combination of said stent members and said intra-nasal projecting members defining a pair of intra-nasal shaping assemblies; wherein said intra-nasal shaping assemblies are adapted to be positioned in the nostrils of the patient having a cleft lip deformity and said extra-nasal shaping assemblies are adapted to be positioned along the alar creases of the patient, such that the tissue of the patient is retained between the intra-nasal shaping assemblies and the extra-nasal shaping assemblies, and whereby said intra-nasal shaping assemblies are separable by manually flexing said spring segment, and whereby upon release said spring segment brings said intra-nasal shaping assemblies together over an arced pathway. Still further, such a device wherein said intra-nasal projecting members each comprise a base portion and an elongated post portion, and wherein said extra-nasal arm members are connected to said base portions of said intra-nasal projecting members; wherein each of said stent members comprises a rounded, radially-projecting body; said unitary biasing member further comprising a pair of helical spring members, wherein said intra-nasal projecting members are connected to said central spring segment by said helical spring members; each of said base portions of said intra-nasal projecting members comprising a cavity, and said helical spring members being received within said cavities of said base portions of said intra-nasal projecting members. 
         [0010]    Still further alternatively summarized, the invention is a nasal molding device adapted for pre-surgical molding of cleft lip deformities in a patient, said device comprising a biasing member composed of a polymer material and comprising a U-shaped central spring segment, a pair of tubular intra-nasal projecting members and a pair of extra-nasal arm members, wherein said intra-nasal projecting members are connected to said central spring segment and said extra-nasal arm members are connected to said intra-nasal projecting members; a cover member disposed on each of said extra-nasal arm members, the combination of said cover members and said extra-nasal arm members defining a pair of extra-nasal shaping assemblies; a tubular stent member disposed on each of said intra-nasal projecting members, each of said stent members comprising a rounded, radially-projecting body, the combination of said stent members and said intra-nasal projecting members defining a pair of intra-nasal shaping assemblies; wherein said intra-nasal projecting members each comprise a base portion and an elongated post portion, and wherein said extra-nasal min members are connected to said base portions of said intra-nasal projecting members; said biasing member further comprising a pair of helical spring members, wherein said intra-nasal projecting members are connected to said central spring segment by said helical spring members, each of said base portions of said intra-nasal projecting members comprising a cavity, and said helical spring members being received within said cavities of said base portions of said intra-nasal projecting members; wherein said intra-nasal shaping assemblies are adapted to be positioned in the nostrils of the patient having a cleft lip deformity and said extra-nasal shaping assemblies are adapted to be positioned along the alar creases of the patient, such that the tissue of the patient is retained between the intra-nasal shaping assemblies and the extra-nasal shaping assemblies, and whereby said intra-nasal shaping assemblies are separable by manually flexing said spring segment, and whereby upon release said spring segment brings said intra-nasal shaping assemblies together over an arced pathway and/or further wherein said biasing member is a unitary biasing member. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a perspective view of an embodiment of the invention comprising a unitary biasing member. 
           [0012]      FIG. 2  illustrates the unitary biasing member of the embodiment of  FIG. 1 . 
           [0013]      FIG. 3  is a perspective view of another embodiment of the invention comprising a unitary biasing member having a pair of helical spring members in addition to a U-shaped central spring segment. 
           [0014]      FIG. 4  is a bottom view of the embodiment of  FIG. 3 . 
           [0015]      FIG. 5  is an illustration of an embodiment of the tubular stent member. 
           [0016]      FIG. 6  is an illustration of an alternative embodiment of the tubular stent member. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0017]    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. 
         [0018]    Embodiments of the invention are shown in  FIGS. 1 through 6 , wherein the device comprises a biasing member  10 , and most preferably a unitary biasing member  10 . The term “unitary” shall be taken to mean a member formed as a single piece, preferably formed of a polymer material and shaped by molding, CAD sculpting, 3-D laser deposition printing, rapid prototyping of the like. The biasing member  10  is flexible such that it may be flexed or tensioned in order to create a biasing force that is then transferred to the patient. 
         [0019]    In a basic embodiment as shown in  FIGS. 1 and 2 , the biasing member  10  comprises a U-shaped central spring segment  11 , a pair of intra-nasal projecting members  12 , preferably tubular, and a pair of extra-nasal arm members  13 , wherein the intra-nasal projecting members  12  are connected to the central spring segment  11  and the extra-nasal win members  13  are connected to the intra-nasal projecting members  12 , preferably formed as a single member and defining a unitary biasing member  10 . 
         [0020]    The extra-nasal arm members  13  are preferably elongated post members and may be provided with retention members  33  to retain a cover member  31 , preferably removably disposed coaxially on each of the extra-nasal arm members  13 , the combination of the cover members  31  and the extra-nasal arm members  13  defining a pair of extra-nasal shaping assemblies  30 . The cover members  31  are preferably formed of a compressible, biocompatible polymer material, and may be provided with an enlarged tip  32 . 
         [0021]    A stent member  21 , preferably tubular, is disposed on each of the intra-nasal projecting members  12 , each of the stent members  21  preferably comprising a hollow core  41  and a bulbous or rounded, radially-projecting body  42 , as shown in  FIGS. 5 and 6 , the combination of the stent members  21  and the intra-nasal projecting members  12  defining a pair of intra-nasal shaping assemblies  20 . Tubular intra-nasal projecting members  12  and tubular stent members  21  are preferred to allow for passage of air through the members. The radially-projecting bodies  42  extend the nostrils in the desired directions when the device is in use. Preferably the stent members  21  are removable and replaceable, and may be rotated on the projecting members  12  as desired. Different sized stent members  21  may be utilized. The stent members  21  are preferably formed of a compressible, biocompatible polymer material. 
         [0022]    The intra-nasal projecting members  12  may each comprise a widened base portion  22  and an elongated post portion  23 , such that the extra-nasal arm members  13  are connected to the base portions  22  of the intra-nasal projecting members  12 . The post portions  23  of the intra-nasal projecting members  12  may be provided with retention members  26  to better secure the stent members  21 . 
         [0023]    In another alternative embodiment shown in  FIGS. 3 and 4 , the biasing member  10  further comprises a pair of helical coil spring members  24 , the helical coil springs  24  connecting the intra-nasal projecting members  12  to the central spring segment  12 . Preferably, the biasing member  10  of this embodiment is formed as a unitary biasing member  10 . In a preferred embodiment, the based portions  22  each comprise a recess or cavity  25 , such that the helical coil spring members  24  extend into and are received within the cavity  25  of the base portions  22 . The combination of the central spring segment  11  and the helical coil spring members  24  enables the unitary biasing member  10  to have a plurality of tensions, such that the extra-nasal shaping assemblies  30  can be rotated and tensioned relative to the intra-nasal shaping assemblies  20  independently of the tension provided by the central spring segment  11 , or such that the combination of the three springs  11  and  24  provides tensioning about multiple tension focal points. 
         [0024]    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.