Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority of Provisional Patent Application Ser. No. 61/308,397 filed on Feb. 26, 2010. 
    
    
     FIELD 
     This disclosure relates to a pacifier. 
     BACKGROUND 
     Once an infant begins to turn its head with neck extension, suckling becomes an active oral pattern with large up and down, forward/back and lateral or excursive movements of the jaw; and rhythmic peristaltic 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 which can obstruct oral airway patency. 
     SUMMARY 
     This invention features in one embodiment a pacifier for use with premature newborns and infants comprising a shield and a hollow bulb projecting from one side of the shield, the bulb defining a generally rectangular cross-sectional profile along at least a portion of its length from the shield to its distal free end. 
     This embodiment optionally includes one or more of the following features. The bottom side of the bulb can define one or more depressions to guide the tongue during swallowing. The longitudinal axis of the bulb can be tipped upward such that it is higher at the distal end of the bulb than it is at the base of the bulb. The shield may be flexible and/or it may be angled relative to the bulb and/or angled away from the chin toward its lower portion, all of which helps to allow the mandible to move forward thus opening the airway for better breathing. The pacifier is preferably made by injection molding of a 50-65 Shore A Medical Grade silicone or equivalent material. Wall thicknesses of the pacifier will typically range from about 1 mm to about 1.5 mm to meet current U.S. and international safety codes. The preferred embodiment has a nominal 1.5 mm wall thickness, but may vary. The pacifier can be molded in a single shot, or the nipple or bulb may be molded as one stage and the shield portion over molded as a second stage. 
     This embodiment optionally includes one or more of the following additional features. The bulb shape may encourage sucking, swallowing and breathing and coordination thereof. The pacifier may include a flexible handle that bends or collapses when the child rolls onto it, to help prevent a choking hazard while maintaining an open airway. The handle can be used by the caregiver to guide, place or retrieve the pacifier. The pacifier may include a hard plastic ring molded into a soft silicone (or equivalent) shield allowing for a more contoured shield and also more open areas for venting the skin/cheeks. The tip of the bulb may be open and designed to be interference fitted with an intubation tube or other tool/instrument. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A-1D, 2A-2D and 3A-3D  illustrate three similar embodiments of the pacifier. 
         FIG. 4  illustrates an angled lower shield portion of a pacifier. 
         FIGS. 5-10  are views of a preferred embodiment:  FIGS. 5 and 6  are perspective views showing the bulb of a preferred embodiment.  FIGS. 7A-7F  are vertical sections through this bulb at different distances from the shield toward the distal tip, looking toward the tip.  FIG. 8  is a vertical section through the center of the pacifier.  FIG. 9  is a horizontal midline section looking from the bottom to the top.  FIG. 10  is a highly schematic cross-sectional view of the bulb in place against the palate, illustrating one aspect of its functionality. 
         FIGS. 11A-11C  show another embodiment with a bulb with an external shape that is more rounded than that of the embodiments shown in  FIGS. 1-10 . 
         FIGS. 12A and 12B  are vertical sections through another embodiment from the base looking toward the tip, similar to the views of  FIGS. 7A and 7C . 
         FIG. 13  is a simplified cross section through an alternative construction of a shield. 
         FIG. 14  shows an embodiment with an open tip, to allow the insertion and removal of devices such as medical devices. 
     
    
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
     Preferred embodiments of the invention are shown in the drawings.  FIGS. 1A-1D and 2A-2D  are various views (with preferred dimensions in millimeters) of embodiments that are most useful for infants of gestational ages 34 weeks and older. Another embodiment for infants of gestational age 28 plus weeks is shown in  FIGS. 3A-3D . The embodiments of  FIGS. 1-3  are largely the same in terms of their external and internal shape and construction, and differ mainly in their dimensions.  FIG. 4  shows the angled lower shield portion of one non-limiting embodiment. 
       FIGS. 5-10  are views of a preferred embodiment.  FIGS. 5 and 6  are perspective views showing the bulb of a preferred embodiment.  FIGS. 7A-7F  are vertical sections through this bulb at different distances from the shield toward the distal tip, looking toward the tip, showing the generally rectangular cross-sectional shape and other aspects of the shape. The distances from the shield are 6 mm, 10 mm, 15 mm, 18 mm, 20 mm and 21 mm, respectively.  FIG. 8  is a vertical section through the center of the pacifier.  FIG. 9  is a horizontal midline section looking from the bottom to the top.  FIG. 10  is a highly schematic cross-sectional view of the bulb in place against the palate, illustrating one aspect of its functionality. 
     DETAILED DESCRIPTION OF THE INVENTION 
     Shield  12  of pacifier  10 ,  FIGS. 1A-1D , preferably defines a generally circular circumference or contour, with a generally partially-circular depression or cutout  20  at the top, above the hollow bulb. Area  20  spans the width of the shield and is depressed to a location very close to the base of the bulb. This provides room for a nasal cannula that would not be interfered with by the pacifier. Pedestal or raised area  16  defines a transition region between shield  12  and bulb  14 . Pedestal  16  can be thicker toward the bottom as shown in  FIG. 1B  so as to create a distal face that is angled relative to the face of shield  12 . If the bulb axis is normal to the face of the pedestal, the pedestal thus defines the angle of the bulb relative to the shield. Another feature of the pacifier is the solid arc-shaped soft projecting blade-type handle  18  that provides a means for a caregiver to hold and manipulate the pacifier. 
     Bulb  14  defines several functional features. For one, the central longitudinal axis  29  of bulb  14  is tilted upward with respect to the surface of shield  12  such that axis  29  lies at about a five to eight degree angle to horizontal  31  that is normal to the surface of shield  12  (five degrees in bulb  14 ,  FIG. 1  and eight degrees in bulb  14   a ,  FIG. 2 ). This angle moves the lower portion  34  of shield  12  slightly away from the chin, which takes pressure off the chin to allow for normal mandibular positioning. This also allows for forward motion of the mandible that enhances opening of the airway. Additional means to assist in this functionality can be accomplished by angling lower shield portion  34  such that it angles away from the chin (e.g., it follows axis  36 ). As shown in  FIG. 4 , this angle is preferable 15 degrees from the plane of the shield, although any angle greater than zero degrees would assist and the angle could be increased as long as it did not affect other functionalities of the pacifier. In the embodiment of  FIG. 4  the angle begins about 10 mm below the center of the nipple. A desired flexibility of lower portion  34  of shield  12  (to allow for mandible positioning and movement) can also be accomplished by making portion  34  thinner, or of a different material, and/or by including depressions  38  ( FIG. 8 ) in this lower portion. Depressions  38  may be arc-shaped, but need not be. Depressions  38  cause a thinning and thus a weakening that accomplishes or at least augments the desired flexibility. 
     The shape of the bulb of the preferred embodiment is detailed in many of the drawings. In general, through its wall shape and configuration and the shapes of its internal and/or external surfaces the bulb helps to gently support the arch while encouraging sucking, swallowing and breathing and the coordination of these three bodily functions in the premature infant. Bulb  14  is bilaterally symmetric about vertical mid plane  30 . The top or dorsal surface  50  of bulb  14  is typically flat or generally flat and sufficiently wide to accommodate and gently support the palatal arch form so as to enhance palatal development. The shape, size and width of dorsal surface  50  can be varied to accomplish a desired amount of contact with the arch, desired contact locations, and desired stiffness and support. A smaller contact area may allow for more normal saliva flow, thus encouraging important physiologic behaviors and development. 
     In this embodiment, angled areas  70  located toward the distal tip where the top  50  and lateral surfaces  60  merge into one another create surfaces that also help to support the arch  71  as shown in  FIG. 10 . Areas  70  can also be used to vary the width of area  50  and thus the amount of and locations of tissue contact. Contact of area  50  with the arch can also be decreased by depressing or cupping portions of it, or adding a longitudinal groove to it, for example. 
     Due at least in part to its generally rectangular cross-section, bulb  14  is fairly rigid in compression resulting from forces on sides  60  and areas  70 . The bulb thus inhibits movement of the arch  71  about the suture  72  so as to encourage normal arch development. Bulb  14  in this sense acts like a hollow structural section spanning the arch, and so helps to maintain normal physiology even during a sucking action in which muscular forces otherwise would tend to collapse the arch and the alveolar ridge  73  inward toward the vertical plane of the palatal suture. 
     Lateral surfaces  60  also help to allow for normal volumetric expansion of the bulb during peristalsis. This enhances the sensory stimulation for accelerated tongue strength and physiologic tongue reflex control. Bottom or lingual surface  100  defines near distal tip  15  a depression  102  that helps to guide and place the tongue. This depression allows for more normal tongue movement to help to develop the efficiency of early and late peristaltic movement. This further enhances the sensory stimulation for increased functional tongue strength and physiologic tongue reflex control. As shown in  FIGS. 1B and 3B , the surface of depression  102  preferably defines an angle of about 165 degrees with the horizontal. Depression  104  located more proximally than depression  102  can also assist with this functionality by allowing the tongue to move forward as if it were accepting a mother&#39;s nipple/breast. 
     Anterior lateral tip surfaces  80  are angled inward from widest section  130 . These areas allow for stretching and flexing of the tip and again simulation for the child to learn to accept new surfaces/textures, essential when accepting the breast and/or later on in accepting foods. 
       FIGS. 11A-11C  show another embodiment of nipple  130  with a bulb with an external shape that is more rounded like a conventional orthodontic pacifier than that of the embodiments shown in  FIGS. 1-10 . Nipple  130  comprises bulb  132 , neck  136  and base  134  that would be connected to the shield, which is not shown in these drawings for clarity purposes only.  FIG. 11B  is a section along line B-B of  FIG. 11A , and shows the external more rounded shape as well as the internal shape defined by internal cavity  133 .  FIG. 11C  is a horizontal section along line C-C of  FIG. 11A , similar to that of  FIG. 9 . In this embodiment the I-beam truss structure appears on the inside surface of the bulb. It is created by the shape of the core pin used in molding the nipple. The result is a varying bulb wall thickness particularly in the upper half of the bulb to create the truss shape inside of the more rounded exterior. This provides generally the same function of support against the top of the palate as do the previous embodiments, but accomplished more internally than the others. 
       FIGS. 12A and 12B  are vertical sections through another embodiment of a nipple  150 , at different distances from the base looking toward the tip, similar to the views of  FIGS. 7A and 7C . This is another example similar to that of  FIG. 11  in which the support is accomplished more internally to allow a rounder outside shape to accomplish a more normal outward appearance for an orthodontic pacifier. Nipple  150  includes base  152  and bulb  154 . Rounder external shape  155 , central hollow core  157  (created via a pin) and tongue pad  158  are shown. 
       FIG. 13  is a simplified cross section through an alternative construction of pacifier shield  140 . Hard plastic ring  142  is overmolded with a soft silicone or equivalent material  144 . The structure of the harder interior allows for more contour to the shield and also more open areas for venting the skin and cheeks. 
       FIG. 14  shows bulb  150  in which tip  152  is open to allow the insertion and removal of devices such as medical devices. For example, an intubation tube  154  can be fitted into the infant through the bulb, as can other tools or instruments. Alternatively, space for an intubation tube or other device, tool or instrument can be accomplished with a longitudinal groove in dorsal surface  50 . 
     Although certain features are shown together in several of the drawings, this is not a limitation of the invention, as all features need not be included in all embodiments. Also, the dimensions in the drawings illustrate certain embodiments but are not limitations of the invention. 
     The following claims illustrate certain aspects of the invention to be claimed, but are not exhaustive and do not set forth the full scope of the invention.

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