Abstract:
A shield for a pacifier, teether, feeding device, sippy cup or the like. The shield carries a structure that is adapted to be inserted into the mouth of a young child. There is a body defining an opening at which the structure is carried and an inner surface surrounding this opening and encompassing the perioral areas surrounding the lips. The body defines a superior portion superior to the opening and an inferior portion inferior to the opening, and defines a lateral axis passing laterally through the opening. The superior portion is generally concave laterally on both sides of the vertical midline, to define an inner surface that closely conforms to the upper lip and perioral areas. At least the part of the inferior portion close to and on either side of the vertical midline is offset outward away from the face compared to the inner surface of the superior portion that is close to and on either side of the vertical midline, to allow the mandible to move anteriorly without being inhibited by the shield.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims priority of Provisional Patent Application Ser. No. 61/377,655 filed on Aug. 27, 2010. 
     
    
     FIELD 
       [0002]    This disclosure relates to a shield for a pacifier or other structure that is to be placed in the mouth of an infant. 
       BACKGROUND 
       [0003]    Once an infant begins to turn his head with neck extension, suckling becomes an active oral pattern with large up and down and forward/back movements of the jaw; and rhythmic forward/back movement of a cupped tongue. The newborn&#39;s respiratory function is characterized by obligatory nasal breathing because of the close approximation of the tongue to the soft palate and posterior pharyngeal wall, which can obstruct oral airway patency. 
         [0004]    The perioral region is richly supplied with neural mechanoreceptors capable of inducing the tissue changes associated with movements of the lower face (Barlow 1991). 
         [0005]    Human lip muscles display excitatory reflex responses. Particular attention is directed to the obicularis oris, buccinators muscles, mentalis muscles and underlying bone as being supportive/resting areas of the pacifier shield. 
         [0006]    Oral shields are commonly used in applications such as pacifiers, teethers, feeding devices and sippy cups. Shield designs (Panicci, U.S. Pat. No. 4,403,613 and Uehara, U.S. Pat. No. 6,767,357) disclose the lower part of the shield slightly curving away from the face. The Panicci design is not sufficiently offset to allow for free forward posturing of the mandible. Additionally, Panicci does not recognize the need to be supportive only on upper arch, and is not designed based on available anthropometrics. Panicci (in contradiction to the present invention) will intensify the sensory and motor components against the lower lip and contribute a retrusive stimulation and force against the mandible and other areas below the upper arch and intermaxillary space. This reflex will actually cause more restriction of the upper airway. 
         [0007]    The relative magnitudes of lip-muscle reflex components are known to vary in a systematic manner with the stimulation of the lip muscle and site of stimulation. 
         [0008]    Current designs of pacifier baglets (to be differentiated from the pacifier shield) claim benefits to orthodontic development, particularly of the maxillary arch. These designs are often paired with different oral shields for corresponding size or marketing purposes. Beyond these claims of orthodontic benefits, pacifiers have also been shown to reduce the incidence of SIDS (Sudden Infant Death Syndrome). The mechanism of this protection is believed to be in the maintenance of a patent oral airway during infant sleeping in a supine position and pacifier sucking. It has been hypothesized that the association of pacifier use with reduced risk of Sudden Infant Death may be mediated by forward movement of the mandible and tongue. Pacifier use helps to open the upper airway and further to move the mandible forward when an infant is sucking on a pacifier (Tonkin S L, Lui D, McIntosh C G, Rowley S, Knight D B, Gunn A J., Effect of Pacifier Use on Mandibular Position in Preterm Infants, Acta Paediatr, 2007, October; 96(10):1433-6. Epub 2007 Aug. 20). Retroposition of mandibles have been considered an additional risk factor for sudden infant death. (Rees K, Facial Structure in the sudden infant death syndrome: case control study, BMJ1998 317:179-180) Forward posturing of the mandible may therefore increase the efficiency of the oral airway. Further Tonkin found that there was significant forward movement of the mandible when premature infants were sucking on a pacifier, and he proposed that the common pathologic mechanism of SIDS was airway occlusion by backward displacement of the tongue and mandible (Tonkin SL et al., Positional upper airways narrowing and an apparent life threatening event, NZ Med J 2002 115:193-4; Tonkin S., Sudden Infant Death Syndrome: Hypothesis of Causation, Pediatrics 1975; 55:650-661). 
         [0009]    Further, treatment of airway obstruction by mandibular advancement and distraction osteogenesis, used to eliminate mandibular retrognathia and malposition of the tongue, is also used as a surgical solution for airway obstruction in some cases (Bouchard C., Management of Obstructive Sleep Apnea: Role of Distraction Osteogenesis, Oral Maxillofacial Surg ClinN Am 21 (20090459-475)). 
         [0010]    The design of the pacifier shield has largely been based on safety testing/requirements, ease of manufacturing, skin health and moisture retention under shield, handle grip, sized generally “to fit” at different ages, esthetics and marketability. The approximation of the shield against the face, and particularly against the perioral region, can have a restrictive effect on the posturing of the lower jaw during sucking. The retrusive pressure of the shield against the lower perioral region may play an unreported, but significant role in reducing the beneficial effect that infant pacifier sucking has on the airway of the infant. The shield may in fact, discourage a more forward mandibular posture during sucking of the baglet as the shield is pulled back tight against the inferior perioral area; more specifically the anterior mandibular alveolus, erupting mandibular incisors and mandibular symphysis. This inward suck force creates a strong posteriorly-directed pressure of the shield against the mandible. 
       SUMMARY 
       [0011]    Reproducible standardized biomarkers of the face of infants are available in the literature. Cephalometric radiology, anthropometry, stereo-photometry and most recently apical CT have been used on cohorts of infants of differing ages, sex, inter-racial differences and nationalities. Examples are—Waitzman A. A. et al., Craniofacial Skeletal Measurements based on Computed Tomography: Part II Normal Values and Growth Trends, Cleft Palate-Craniofacial J March 1992 29(2): 118-128; or White J. E. et al., Three Dimensional Facial Characteristics of Caucasian infants without clefts and correlation with Body measurements, Cleft palate-Craniofacial J 41((6)2004:593-602; or Yamanda T et al., Three Dimensional Analysis of Facial Morphology in Normal Japanese Children, CP-Cranio-facial J 39(5) 2002; 517-526. These previously published data allow for development of shield dimensions for different cohorts which then can result in the inventive shield being marketed to populations of different ages, in varying demographics, and/or with varying facial features. 
         [0012]    The principle of designing a shield based on available standardized biomarkers of the face, as applied in the current inventive shield, can focus on the following non-limiting biomarkers that most closely describe the key perimeter values and contact points for a shield. 
         [0013]    Using normal transverse lip length data (male and female combined) within the first year of life, the period in which the American Academy of Pediatrics recommends pacifier use: 
         [0000]    
       
         
               
               
               
               
             
           
               
                   
               
             
             
               
                 1 month 
                 Mean (1.08″) 
                 Range (0.98″-1.26″). 
                 Normal lip position. 
               
               
                 1 year 
                 Mean (1.28″) 
                 Range (1.14″-1.50″). 
                 Normal lip position. 
               
               
                   
               
             
          
         
       
     
         [0014]    Extended lip measurements were extrapolated to be approximately 0.5″ greater when using data from older children, extrapolated to infants. 
         [0015]    Further analysis of Nasion-Stmion Distance minus Nose length distances provides the dimensions from under the nose (point sub-Nasale) to the lower lip and chin projection (the most posterior point along the symphysis menti, inferior to the infradentale point and superior to the mental protuberance): 
         [0000]    
       
         
               
               
               
             
           
               
                   
                   
               
             
             
               
                   
                 1 month 
                 Mean (1.58″-0.88″ = 0.70″) 
               
               
                   
                 1 year 
                 Mean (1.76″-1.02″ = 0.74″) 
               
               
                   
                   
               
             
          
         
       
     
         [0016]    Further continuing the example, we considered the Bigonial Diameter (the greatest distance between the lateral gonial angles of the mandible): 
         [0000]    
       
         
               
               
               
               
             
           
               
                   
                   
               
             
             
               
                   
                 1 month 
                 Mean (2.85″) 
                 Range (2.72″-3.07″). 
               
               
                   
                 1 year 
                 Mean (3.06″) 
                 Range (2.92″-3.27″). 
               
               
                   
                   
               
             
          
         
       
     
         [0017]    Note: all illustrative data taken from Young J W; Selected Facial Measurements of Children for Oxygen-Mask Design Report #AM 66-9; Office of Aviation Medicine Federal Aviation Agency, April 1966. 
         [0018]    Using this cohort data were are able to design a better fitting shield for nose breathing, a better fitting shield—both fitting the face and allowing for more forward mandible position. 
         [0019]    This disclosure features a shield for a pacifier, teether, feeding device, sippy cup or the like, wherein the shield carries a structure that is adapted to be inserted into the mouth of a young child. The shield comprises a body defining an opening at which the structure is carried and an inner surface surrounding this opening and encompassing the perioral areas surrounding the lips. The body defines a superior portion superior to the opening and an inferior portion inferior to the opening, and defines a lateral axis passing laterally through the opening. The superior portion is generally concave laterally on both sides of the vertical midline, to define an inner surface that closely conforms to the upper lip and perioral areas. At least the part of the inferior portion close to and on either side of the vertical midline is offset outward away from the face compared to the inner surface of the superior portion that is close to and on either side of the vertical midline, to allow the mandible to move anteriorly without being inhibited by the shield. 
         [0020]    The most lateral parts of the inferior portion of the body may curve back towards the perioral area. The body may define a generally butterfly, round or heart shape from side-to-side. The inferior portion may be angled away from the face. The inner surface of the superior portion may define a curved planar area. At least most of the inferior portion may be offset from the superior portion. The superior and inferior portions may be angled away from the mid-portion to create a convex dome shape. The inferior portion may be offset and angled sufficiently so as to provide room between the shield and face to allow a feeding tube to be placed into the mouth without causing the superior portion of the shield to be thrust into the upper lip. The shield may be supported by contact with the maxillary arch. 
         [0021]    The shield may be generally symmetric about both the lateral and vertical midlines so that it can be oriented with the superior portion above or below the opening. The shield may define offset pockets that span the vertical centerline at the peripheries of both the superior and inferior portions, to allow room for the mental protuberance to be able to move forward during use. The shield may further comprise a plurality of support pads that are in contact with the user&#39;s cheek infra-orbitally and in the maxillary perioral area. The shield may comprise at least four support pads symmetrically arranged about both the vertical and lateral midlines. 
         [0022]    The shield may be dimensioned based on a user cohort derived from one or more of photographic, cephalometric, anthropometric, stereo-photometric and apical CT data. The shield may be constructed and arranged to allow forward movement of the mandible during sucking. The shield may be constructed and arranged to allow downward movement of the mandible during sucking. The shield may be constructed and arranged to allow for maxillary lip support, infra-orbital cheek support, infra nasal support and intermaxillary freeway space support. 
         [0023]    Featured in another embodiment is a shield for a pacifier, teether, feeding device, sippy cup or the like, wherein the shield carries a structure that is adapted to be inserted into the mouth of a young child, the shield comprising a body defining a generally butterfly, round or heart shape from side-to-side, and an opening at which the structure is carried. There is an inner surface surrounding this opening and encompassing the perioral areas surrounding the lips, the body defining a superior portion superior to the opening and an inferior portion inferior to the opening, and defining a lateral axis passing laterally through the opening, wherein the superior portion is generally concave laterally on both sides of the vertical midline, to define an inner surface that closely conforms to the upper lip and perioral areas, wherein the inner surface of the superior portion defines a curved planar area, wherein at least the part of the inferior portion close to and on either side of the vertical midline is offset outward away from the face compared to the inner surface of the superior portion that is close to and on either side of the vertical midline, to allow the mandible to move anteriorly without being inhibited by the shield, and wherein the most lateral parts of the inferior portion of the body curve back towards the perioral area, and at least most of the inferior portion is offset from the superior portion. 
         [0024]    Featured in yet another embodiment is a shield for a pacifier, teether, feeding device, sippy cup or the like, wherein the shield carries a structure that is adapted to be inserted into the mouth of a young child, the shield comprising a body defining a generally butterfly, round or heart shape from side-to-side, and an opening at which the structure is carried. There is an inner surface surrounding this opening and encompassing the perioral areas surrounding the lips, the body defining a superior portion superior to the opening and an inferior portion inferior to the opening, and defining a lateral axis passing laterally through the opening, wherein the superior portion is generally concave laterally on both sides of the vertical midline, to define an inner surface that closely conforms to the upper lip and perioral areas, wherein at least the part of the inferior portion close to and on either side of the vertical midline is offset outward away from the face compared to the inner surface of the superior portion that is close to and on either side of the vertical midline, to allow the mandible to move anteriorly without being inhibited by the shield, wherein the most lateral parts of the inferior portion of the body curve back towards the perioral area, wherein the shield is generally symmetric about both the lateral and vertical midlines so that it can be oriented with the superior portion above or below the opening, and wherein the shield defines offset pockets that span the vertical centerline at the peripheries of both the superior and inferior portions, to allow room for the mental protuberance to be able to move forward during use. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]    Illustrative, non-limiting embodiments are shown in the drawings, in which: 
           [0026]      FIGS. 1A-1C  illustrate a first embodiment of the shield; 
           [0027]      FIGS. 2A-2C  illustrate a second embodiment of the shield; 
           [0028]      FIGS. 3A-3B  illustrate a third embodiment of the shield; 
           [0029]      FIGS. 4A-4C  illustrate a fourth embodiment of the shield; 
           [0030]      FIG. 4D  illustrates a fifth embodiment of the shield; and 
           [0031]      FIGS. 5A-5B  illustrate a sixth embodiment of the shield. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0032]    The present invention encourages the perioral forces, created by the shield against the face, to be stabilized against the upper perioral area (maxillary arch, lip, cheek and intermaxillary arch space), with lighter forces (or no force) against the lower perioral area (mandibular arch). The shield can be used in any application, for example as part of pacifiers, teethers, feeding devices/utensils and sippy cups, which include a structure (such as a nipple or baglet) that goes into the infant&#39;s mouth. 
         [0033]    Part, most of, or all of, the inside surface of the lower or inferior portion (typically the lower half) of the shield is offset from the inside surface of the upper or superior portion of the shield. This moves the inferior portion away from the face. The offset part of the shield is typically offset in the range of about 2 mm to about 10 mm, and more preferably from 2-8 mm, from the upper or superior portion of the shield. The lower offset portion of the shield may also be angled away from the vertical, and away from the face, at more than 0 degrees and up to about 20 degrees. The variation of the degree of angulation of the offset, when angulation is present, will be in part determined by the angle of the bulb or oral device (teether, nipple, spout etc.) which extends from the shield. A greater angle may be used with less of an offset to allow the lower part of the shield to be sufficiently spaced from the face. Similarly, a greater offset may be combined with no angle or a lesser angle. 
         [0034]    The shield design takes on different levels of significance when used with different bulb designs. For example, so called cherry shaped and reverse orthodontic shaped bulbs have straight necks (shafts) and will push, slide, and seat (thereby ‘angle’ upward) into the palate during sucking, and cause greater tipping of the lower part of the shield against the chin than a bulb with a so called orthodontic design which itself is angulated from the neck (shaft) of the bulb, and will thus result in less shield tipping. Thus, greater offset may be needed in a shield for a reverse design in order to prevent the shield from contacting the lower perioral area during use. 
         [0035]    The shield, by stabilizing forces against the upper lip, maxillary arch, cheeks and inter-maxillary freeway space, may also have an added benefit of discouraging protrusion of the maxillary front teeth. 
       Description of Offset: 
       [0036]    The offset could be presented in a number of manners. A number of embodiments that accomplish an offset are described below and shown in the drawings. 
       Embodiment 1 
     FIG.  1   
       [0037]      FIGS. 1A-1C  show a shield  10  with a conventional pacifier shield “butterfly” shape that is curved inward laterally at a 20 degree angle from its horizontal centerline  30 . The 20 degree inward lateral angle can vary; 20 degrees was chosen as a median value. The angle can range from about 10 degrees to about 30 degrees.  FIG. 1A  is a view of shield  10  from the outside  40  that does not touch the face, showing nipple opening  18  and seating flange  19 .  FIG. 1B  is a top view, and  FIG. 1C  a side view. Dimensions are in mm. Note that this design is sized for a 9 month+ infant. Smaller overall dimensions (scaled down) would be used for shields designed for 0 month, 0-3 months, and other ranges as desired, using the dimensional data and ranges set forth above and otherwise available in literature. Shield  10  comprises unitary molded plastic body  12  that defines top edge  14 , lower edge  16 , outer surface  40 , inner surface  39 , central opening  18  (for insertion and seating of a nipple) and openings to provide for passage of air, such as opening  20 . The butterfly curvature is such that axes  34  and  36  that emanate from medial bisecting plane  38  and bisect the lateral edges  35  and  37  lie at about a 20 degree angle to plane  32  that is orthogonal to plane  38 . Additionally, the inferior (below the nipple) portion  42  is extruded outward (away from the face) (i.e., offset) 2 mm-10 mm (in this example 8.5 mm) from main plane  41  of the superior portion  29  that contacts the infant&#39;s face, i.e., the inside surface of the inferior portion  42  at the lowermost extent of the inner face (i.e., point  43 ) is spaced 8.5 mm from plane  41  that contacts the face. 
       Embodiment 2 
     FIG.  2   
       [0038]      FIGS. 2A-2C  are outside, top and inside axonometric views, respectively, of second shield embodiment  50 . The footprint of shield  50  is the same at approximately 60 mm wide by 40 mm height, designed for a 12 month+ infant, but the initial contact with the infant only comes from the corner of the lips and extends just above the upper lip, essentially at the protruding plane bounded by edges  52 - 55 . This plane defines the innermost surface of the shield, and the areas above and below the plane are offset from the plane. The construction prevents the shield from entering the infant&#39;s mouth, but allows the lower part of the shield (below the plane bounded by edges  52 - 55 ) to remain away from the infant&#39;s face. This design could also be described as two shields in one—a small shield that covers from the corner of the lips up to upper edge  57  and a secondary shield that extends from the plane to lower edge  59  that serves to prevent the shield from being swallowed or inhaled by the infant. This design contains the same curvature inward, 20 degrees, but also shows the same offsets of about 2-10 mm. 
       Embodiment 3 
     FIG.  3   
       [0039]      FIGS. 3A-3B  are inside and bottom views, respectively, of shield  80  with a conventional pacifier shield “butterfly” shape that is curved inward laterally at a nominal 20 degree angle from centerline, similar to the shield shown in  FIG. 1 .  FIG. 3A  is a view of shield from the inside that touches the face, while  FIG. 3B  is a bottom view. Opening  82  is for the bulb or other structure that goes into the infant&#39;s mouth, and is bisected by horizontal axis  83 . Above axis  83  is superior portion  91  and below is inferior portion  95 . The offset begins at contour line  93  and extends to lowermost inside location  88 . The upper extent of inside surface  89  is location  86 . Surface  89  is generally concave toward the face to generally follow the contour of the face, thus lateral edges  90  and  92  are located more posteriorly than is the inner part of bulb-receiving opening  82 . Air openings  84 ,  85  and  87  are identified, for context. Inferior portion  95  is sloped away from the face, i.e., offset, to lower contour  101 . What differentiates this design from the  FIG. 1  design is that the outer parts of inferior portion  95 , which end at edges  90  and  92 , curve toward the face similar to the curving of superior portion  91 , such that lateral inferior inside surface portions  103  and  105  are closer to the face than is central lower location  88 . The offset on this design thus creates more of a “pocket” offset located in portion  95  and generally between openings  85  and  87 , as visible in  FIG. 3B . The pocket provides room for the chin/lower mandible to move unobstructed into when the mandible is in the forward or downward position. 
       Embodiment 4 
     FIG.  4   
       [0040]      FIGS. 4A-4C  are front and back views, and a central vertical cross-section, respectively, of a reversible shield  120 ; i.e., a shield that is symmetric about lateral plane  122  so that either “upper” or “lower” edges  142  and  146  can be located just below the nose. Thus, both portion  126  and portion  128  can be the superior or inferior portion. Inside surface  150  is shown in  FIG. 4A . This shield is for the reversible or cherry baglet (pacifier nipple) design. This shield allows for the chin/mandible to move forward or downward without requiring a top/bottom orientation. The key elements to this shield design are that the outer wings  130 ,  132  of the shield (generally located laterally of axes “A” and “B,” respectively,) are designed to firmly contact or “mount” to anatomical structures of the face that are stationary throughout the suck cycle (e.g., the cheeks), and still allow for outward and downward mandibular movement with little or no contact with the shield. Recessed pockets  140  and  144  are bounded by beginning contours  141  and  145  and end contours  142  and  146 , respectively. Pockets  140  and  144  are located centrally, above and below nipple-receiving opening  124 , and end approximately at vertical axes “A” and “B,” outside of which are located wings  130  and  132 . Back side recesses  170  and  171  create annular seat  172  against which the nipple (not shown) is seated. A cap (not shown) would also typically cover the back side of the shield to help conceal/anchor the pacifier baglet, as is known in the art. 
       Embodiment 5 
     FIG.  4 D 
       [0041]      FIG. 4D  is another embodiment of the reversible shield  120   a , which is very similar in design to shield  120 , but with the addition of four support pads  181 - 184 . Using Cranio—facial data (Waitzman et al. and Young J W., supra) these pads are placed nominally 40 mm apart (20 mm off of center of pacifier  190  to center of pads  191 ,  192 , designed for a 12 month+ infant) on the superior  126  and inferior  128  inside surface  150  of the shield and function as mini “bumpers.” The pads could be placed as close as 25 mm apart (center of pad to center of pad) for younger/smaller infants and as much as 42 mm apart for larger children. Vertical spacing from central axis  122  to axes  193  and  194  is about 15 mm, and can range from about 20 mm for older infants to as little as 10 mm for premature infants. The shape of the pads are preferably circular or elliptical, but can take other shapes as well. Shown is a circular embodiment at 7 mm diameter. Minimum diameter may be as low as 5 mm, and spaced approximately 10 mm offset from center in the superior/inferior direction (which is the same as from axis  122  to axes  193 / 194 ). These features may extend out of the shield nominally at 2 mm, +2 mm or −1 mm. Transverse dimensions, although they may vary according to age, sex, nationality and other demographics, would cause the bumpers to contact the infra orbital cheek area and underlying maxillary bone. The pads thus help to anchor the superior portion. The inferior pads lateral placement, however, is too wide to contact the curving mandibular symphysis. 
         [0042]    Likewise, when reversed (superior to inferiorly rotated), the same contacts or non contacts with the perioral areas will also apply to this inventive shield design. Other designs and dimensions are obvious to one skilled in the field. 
       Embodiment 6 
     FIG.  5   
       [0043]      FIGS. 5A and 5B  are front and side views, respectively, of another embodiment of shield  210 . Shield  210  accomplishes the offset of inferior portion  218  from superior portion  216  (located below and above lateral midline  214 , respectively), via angling outward alone, without any planar offset. The angle is typically but not necessarily nominally 20 degrees, to create the “chin pocket” discussed above. 
       Material Options: 
       [0044]    Polycarbonate, polycarbonate frame with silicone overmold, other thermoplastics, urethanes or thermoplastic elastomers that will serve as a rigid barrier (90 A durometer or comprised of sections of softer durometer material, but will contain a rigid section as a frame to pass safety testing/guidelines. 
         [0045]    Other embodiments will occur to those skilled in the field and are within the scope of the claims.