Patent Publication Number: US-2021177705-A1

Title: Pacifier for cooling of oral tissue

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This patent application claims the benefit of U.S. Provisional Application No. 62/946,833, filed Dec. 11, 2019, the content of which is incorporated by reference herein in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present innovation relates to a pacifier for cooling oral tissue, for example, of an infant or child, and more particularly, but not exclusively, for cooling and numbing the gums during teething or other oral treatment in which significantly lowering the temperature of the oral tissue Can reduce inflammation and/or provide immediate relief from pain. 
     BACKGROUND OF THE INVENTION 
     Young children or “babies”, which generally include newborns, infants (e.g., 2 months to a year) and toddlers (e.g., 1-4 years), typically begin teething between the ages of 6 to 24 months. During this time, the child will often feel discomfort due to the inflammation and tenderness associated with the teeth breaking through the gums in their mouth. Various medical treatments can include giving the child an appropriate dose of acetaminophen, ibuprofen, and/or other over-the-counter medications to help numb any pain or discomfort. Alternatively, a doctor can prescribe a prescription drug in severe cases. 
     Many parents and caretakers prefer natural means to help relieve the pain the child experiences during teething. There are many home remedies for relieving pain that occurs from teething which can be easily found in well-known child-care publications or over the internet. Such home remedies can include massaging the child&#39;s gums, wiping excessive drool away, applying vanilla extract, ginger, or oils (e.g., clove or lavender), among many other homeopathic remedies. In addition, cooling of the mouth and the gums has often been found to be very effective to reduce or numb pain emanating from the gums. Ice packs or chilled washed cloths are often applied externally and/or internally. However, they do not evenly cool the mouth and gums. Alternatively, the child can be given a frozen bottle, chilled spoon, frozen banana, an ice pop or other chilled/frozen food substance, among other well-known remedies to reduce inflammation and alleviate pain from the gums. 
     There are numerous pacifiers and teething devices (teething rings) known in the art that retain a liquid which can be selectively chilled or frozen by a parent/caretaker. For example, U.S. Pat. Nos. 3,669,117, 5,300,089, 5,606,871, 5,658,314, and patent application publication nos. 2003/0176891, 2007/0208379, and 2015/0257982 disclose various embodiments of pacifiers/teething devices having a hollow, compressible, nipple portion which are manually filled with water, gel or other liquid coolant or solution, sealed and then cooled in a refrigerator or freezer prior to use. Although such pacifiers and other cooling devices and remedies provide relief to a child during teething, the length of time that the devices can retain their optimum cold temperatures is limited due to the opposing warming effects from being inserted in the child mouth during use, as well as the ambient air temperature of the surrounding environment (e.g., bedroom, kitchen, etc.). Moreover, a cooling device or other well-known remedy that is frozen solid and placed on the gums of the child can also be an unpleasant experience because of the tenderness and sensitivity of the gums to a rough and/or hard texture of the frozen surface, as well as the sudden and substantial temperature drop felt when. placing the frozen device in the child&#39;s mouth. 
     Thus, in view of the inadequacies of the prior art devices and the other well-known treatments/remedies, there is a need for a pacifier to comfortably and effectively cool oral tissue in the mouth of a child for longer durations, and thereby minimize pain caused by, e.g., inflammation and tenderness of the gums which can occur when a child teethes. Furthermore, there has been a need for pacifier that remains comforting to the child throughout the duration of its application to the gums so that relaxation and even sleep can be obtained. 
     SUMMARY OF THE INNOVATION 
     The disadvantages heretofore associated with the prior art are overcome by the present innovation of a pacifier for cooling of oral tissue comprising: a nipple having an outer shell forming an outer chamber which is configured to retain a first cooling medium having a freezing temperature below 0 degrees Celsius, an inner shell forming an inner chamber positioned inside the outer chamber and which is configured to retain a second cooling medium having a freezing temperature above the freezing point temperature of the first cooling medium to assist in chilling the first cooling medium; a handle coupled to a proximate end of the nipple; and a shield positioned between the handle and the proximate end of the nipple. 
     In one aspect, the outer shell surrounds the inner shell to define a gap therebetween in which the first cooling medium is retained. The outer shell can be fabricated from a liquid-impervious and malleable material. For example, the outer shell can be fabricated from silicon. 
     In another aspect, the inner shell can be fabricated from a liquid-impervious and malleable material. For example, the inner shell can be fabricated from silicon. 
     In yet another aspect, the first cooling medium stored in the outer chamber is salt water. In another aspect, the second cooling medium stored in the inner chamber is water. In one embodiment, the first cooling medium stored in the outer chamber is salt water and the second cooling medium stored in the inner chamber is water. Alternatively, the first cooling medium stored in the outer chamber is a gel. In yet another embodiment, the first cooling medium stored in the outer chamber is a gel and the second cooling medium stored in the inner chamber is water. 
     In one aspect, the shield is positioned in a direction normal to a longitudinal axis extending through the nipple. In another aspect, the shield is positioned in a direction substantially normal to a longitudinal axis extending through the nipple. 
     In yet another aspect, the outer shell includes an outwardly extending first flange and the inner shell includes an outwardly extending second flange, the first and second outwardly extending flanges being arranged such that the second outwardly extending flange is positioned between the first outwardly extending flange and the shield. The first and second outwardly extending flanges are secured to the shield by a cap positioned over the first outwardly extending flange to thereby seal the outer and inner chambers closed. 
     In still another aspect, the first and second outwardly extending flanges are in a keyed mating arrangement. Moreover, the shield and second outwardly extending flange can be in a keyed mating arrangement. In another aspect, the cap and the first outwardly extending flange are in a keyed mating arrangement. 
     In one aspect, the cap includes a shoulder circumscribing the first and second outwardly extending flanges and configured and dimensioned to seal the outer and inner shells closed. In another aspect, the handle is formed from a malleable material. The handle can be fabricated from silicon. 
     In yet another aspect, the pacifier comprises a breathing tube extending through the nipple and shield, In another aspect, the pacifier further comprises a first port for filling the outer chamber with the first cooling medium and a second port for filling the inner chamber with the second cooling medium. In one aspect, the first port is formed in the handle. In yet another aspect, the second port is formed in the shield. In still another aspect, the first and second ports are formed in the shield. 
     In one aspect, the nipple comprises a distal end configured for placement against the oral tissue of a child. In another aspect, the oral tissue is the gums of the child. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a top, side, perspective view of a pacifier having nipple formed by a pair of shells respectively defining a pair of chambers which are filled with cooling mediums in accordance with the present innovation, and that can be chilled prior to insertion into a child&#39;s mouth; 
         FIG. 2  is a cross-sectional view illustrating an arrangement of the dual-chambered nipple, a handle and a base, which is illustratively formed by a shield and sealing cap, as taken along a longitudinal axis of the pacifier of  FIG. 1 ; and 
         FIG. 3  is a left-side exploded view of the pacifier base taken from area “A” (drawn in phantom) of the pacifier of  FIG. 2 . 
     
    
    
     To facilitate an understanding of the innovation, identical reference numerals have been used, when appropriate, to designate the same or similar elements that are common to the figures. Further, unless stated otherwise, the features shown in the figures are not drawn to scale, but are shown for illustrative purposes only. 
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present innovation will now be described in detail with reference to the drawings. 
       FIG. 1  illustrates an embodiment of a pacifier  10  in accordance with the present innovation which can be inserted within the mouth of an infant or toddler to relieve pain, burning and/or itching sensations emanating from the gums, for example, during teething. The pacifier  10  includes a first end  12  formed by a nipple  14 , an opposing second end  16  formed by a handle  18  or teething ring, and a base  20  provided between the nipple  14  and the handle  18  in a well-known manner. 
     In one embodiment, the base  20  is illustratively formed by a shield  50  having a lower surface  52  and an opposing upper surface  54 , and an optional cap  56 , as described below in further detail with respect to  FIGS. 2 and 3 . The shield  50  is illustratively shown as being planar or substantially planar, but such configuration is not considered limiting, as the shield  50  can be concave-shaped with respect to the handle  18  or any other well-known curvilinear shape suitable to prevent the child from inadvertently inserting the entire pacifier  10  in the mouth and/or prevent choking on the pacifier  10 . 
     The nipple  14  includes an outer hollow shell  24  defining a first or outer chamber  26  in which a second or inner hollow shell  28  is provided to define an inner chamber  30 . The outer chamber  26  preferably retains a first cooling medium (e.g., salt water solution)  34  and the inner chamber  30  retains a second cooling medium (e.g., pure water)  36  to enable the chilling of the nipple  14  as discussed below in further detail. The first cooling medium  34  retained in the outer chamber  26  has a freezing temperature that is below the freezing temperature of the second cooling medium  36  retained in the inner chamber  30 . In this manner, the liquid in the inner chamber  30  can preferably freeze solid, while the liquid solution in the outer chamber  26  will not freeze and will optimally remain in a slushy and softer state. Accordingly, the outer shell  24  of the nipple  14  which is applied to the gums of the child is soft and malleable, as opposed to being a frozen and rigid surface area. As well, the outer shell  24  is chilled sufficiently to soothe pain from the gums, but it is not at sub-freezing temperatures which can be uncomfortable during use and cause the child to reject the insertion of the pacifier  10  in the mouth. 
     Preferably, salt water and pure water are used as the first and second cooling mediums  34 ,  36 , respectively, because of their safety and ready availability. In one embodiment, the salt water solution includes a mixture of salt in the range of 1% to 25% ratio. In another embodiment, the salt water solution includes a mixture of salt at a 10% ratio, which allows the solution to remain in liquid form down to about 17 degrees F. A person of ordinary skill in the art will appreciate that other types of solutions in which the freezing point of one solution is close to 0 degrees C. (i.e., the second cooling medium) and the other with a freezing point below 0 degrees C. (i.e., the first cooling medium) can be substituted either for the salt water, pure water or both. Although the pacifier  10  of the present innovation is configured to operate at chilled or freezing temperatures, the pacifier  10  can also be used by a child at ambient temperatures in a well-known manner. 
     The outer shell  24  and inner shell  28  are preferably fabricated from a non-porous material which is impervious to seepage of liquid therethrough and is malleable and biocompatible with the infant&#39;s oral tissues such as, for example, acrylic, latex, plastic, silicon and rubber. The shape of the outer shell  24  preferably conforms to and is preferably configured to maximize contact area with the gums of an infant. Further, the nipple  14  is selected to maintain its shape, yet also provide elasticity to allow the child to periodically squeeze the contents with his/her gums and thereby cause the flow of the first cooling medium (salt water solution)  34  within the outer chamber  26 , which effects a massaging sensation on the gums. Moreover, movement of the salt water solution  34  within the outer chamber  26  helps increases contact with the inner shell  28  over time such that the frozen water  36  within the inner chamber  30  acts as a heat sink by convection to thereby enable the salt solution  34  in the outer shell  24  to stay colder for longer periods of time while inserted in the mouth of the child. 
     The outer shell  24  can be bulbous, oval, spoon shaped or any other curvilinear shape to preferably maximize contact area with the gums of the infant. A person of ordinary skill in the art will appreciate that such shapes are not considered as being limiting, as any other well-known shapes can be used to form the outer shell  24 , i.e., the outer surface of the nipple  14 , while still housing the inner shell  28  and its cooling medium contents  36  therein. Accordingly, the inner shell  28  is sized smaller than the outer shell  24  such that a gap “G”  32  is formed between the outer surface of the inner shell  28  and the inner surface of the outer shell  24 . Preferably, the gap  32  surrounds the entire outer surface of the inner shell  28 . In this manner, the inner shell  28  extends or is otherwise positioned freely inside the outer shell  24 , which allows the second cooling medium  36  to expand during freezing and contract should the ice begin to melt. However, in other embodiments, the inner shell  28  can be attached to the inside surface of the outer shell  24  at one or more locations to maintain its relative position within the outer chamber  26 . The inner shell  24  preferably has an elongated length and can have the same shape as the outer shell  28  or be shaped as a rectilinear or cylindrical rod and/or have a bulbous, oval or any other curvilinear shape, although such shapes are not considered limiting. In yet another embodiment, the inner shell  28  can be formed as one or more independent enclosures (not shown) that contain the second cooling medium  36  and which float freely within the outer shell  24  when the pacifier  10  is in an unfrozen state. 
     Referring to  FIGS. 2 and 3 , the outer shell  24  includes a proximal end  38  and a distal end  40  along the longitudinal axis “L” ( FIG. 1 ) of the nipple  14 . Similarly, the inner shell  28  includes a proximal end  42  and a distal end  44  along the longitudinal axis “L” of the nipple  14 . The proximal ends  38 ,  42  of the outer and inner shells  24 ,  28  are adjoined to the base  20 , and the distal ends  40 ,  44  of the outer and inner shells  24 ,  28  contain the first and second cooling mediums within the nipple  14 , which is inserted into the mouth of the child during use. The proximal ends  38 ,  42  of the outer and inner shells  24 ,  28  each terminate with an outwardly extending flange  46 ,  48  respectively. The outwardly extending flange  46 ,  48  preferably extend around the entire perimeter outer and inner shells  24 ,  28 , respectively, although such configuration is not considered limiting. 
     Referring now to the enlarged view of the base  20  as shown in  FIG. 3 , the outwardly extending flanges  46 ,  48  extend in a direction normal or substantially normal to the longitudinal axis L of the nipple  14 . Although, the peripheral edges of the flanges  46 ,  48  are illustratively shown radiating to a same length from the central longitudinal axis L, such configuration is not considered as limiting, as the first and second flanges  46 ,  48  can have differing lengths from the longitudinal axis L. For example, the first flange  46  can radiate further than and overlap the second flange  48 , or vice versa. 
     The outer shell  24  and its outwardly extending flange  46  are positioned over the inner shell  28  and its outwardly extending flange  48  in a stacked or nested arrangement. Illustratively, an inner surface  58  of the outwardly extending flange  48  of the inner shell  28  is positioned adjacent to the lower surface  52  of the shield  50 , while an inner surface  62  of the outwardly extending flange  46  of the outer shell  24  is positioned adjacent to an outer surface  60  of the outwardly extending flange  48  of the inner shell  28 . Preferably, the inner and outer surfaces  52 ,  58 ,  60 ,  62 ,  64  of the shield  50  and flanges  46 ,  48  are in a keyed arrangement  70  such that the adjacent surfaces are locked together to help seal the respective liquid contents within the chambers  34 ,  36  therein. in the embodiment shown in the drawings, a tongue and groove arrangement is provided between the inner surface  52  of the shield  50  and the inner surface  58  of the second outwardly extending flange  48 . Similarly, a tongue and groove arrangement is provided between the outer surface  60  of the second outwardly extending flange  48  and the inner surface  62  of the first outwardly extending flange  46 . Although the tongue and groove arrangement preferably circumscribes both the inner and outer surfaces  52 ,  58 ,  60 ,  62 ,  64  of the shield  52  and flanges  46 ,  48 , such keying arrangement  70  is not considered limiting, as persons of ordinary skill in the art will appreciate that other keying arrangements can be implemented. For example, one or more paired sets of recesses and dimples, or other mating elements can be provided to maintain the positioning of the outer shell  24 , inner shell  28  and shield  50  with respect to each other. The inner surface  52  and the inner/outer surfaces of the flanges  46 ,  48  can be bonded and sealed together in a water-tight manner by welding, with an adhesive sealant or any other well-known fastener. 
     For example, a cap  56  can be optionally mounted over the outer surface  64  of the first flange  46  of the outer shell  24  to lock the outer and inner shells  24 ,  28  to the shield  50 . The cap  56  can include a shoulder  66  which circumscribes the edges of the flanges  46  and  48 . The shield  50  can include a recess  68  in the lower surface  52  in which the stacked flanges  46  and  48  are inserted into, and the cap  56  is attached over the outer surface  64  of the first flange  46  to tightly secure both flanges  46 ,  48  to the shield  50  so that the first and second cooling mediums  34 ,  36  cannot leak out of the respective chambers  26  and  30 . The cap  56  can be threaded or otherwise fastened to the shield  50  in a water-tight manner to secure the flanges against each other and the inner surface  52  of the shield  50 . In one embodiment, the shoulder  66  of the cap  56  is threaded over an edge  68  of the shield  50 . In another embodiment, an inner surface  70  of the cap  56  is in a keyed arrangement  70  with the outer surface  64  of the first flange  48  and is secured thereto by an adhesive or other sealant. A person of ordinary skill in the art will appreciate that the cap  56  can be secured to the shield  50  via a screw-fit arrangement, a snap-fit arrangement, a heat activated adhesive, and/or any other type of mechanical and/or bonding agent or adhesive. 
     As well, a person of ordinary skill in the art will appreciate that the flanges  46 ,  48  can be both bonded together and secured with the shield  50  with or without implementing the cap  56 . Alternatively, the flanges  46  and  48  can float between the inner surface  70  of the cap  56  and the inner surface  52  of the shield  50  without the use of an adhesive or sealant. in this embodiment, the cap  56  is tightly secured over the flanges  46 ,  48  and to the shield  50 , such that the tongue and groove or other keyed arrangement  70  provided between the shield  50 , flanges  46 ,  48  and cap  56  maintains separation of the first and second coolant mediums without leakage therebetween or from the pacifier  10 . 
     Referring to  FIG. 1 , the handle  18  is attached to or is integral with the upper surface  54  of the shield  50 . The handle is preferably tubular in shape and configured so that the child can grip the handle by hand. A person of ordinary skill in the art will appreciate that the handle  18  can be circular or any other curvilinear shape, and can be used by the child as a teething ring in addition to the nipple  14  of the pacifier  10 . 
     As discussed above, the outer shell  24  and inner shell  28  are preferably fabricated from a non-porous material which is impervious to seepage of liquid therethrough and is malleable and biocompatible with the infant&#39;s oral tissues such as, for example, acrylic, plastic, silicon, rubber and/or combinations thereof. Similarly, the base  20  (i.e., shield and optional cap) and handle  18  are also fabricated from the same or similar biocompatible, non-porous and malleable materials. A person of ordinary skill in the art will appreciate that during use, the pacifier  10  can be subjected to a broad range of temperatures, such as freezing temperatures e.g., −25 degrees C. to much hotter temperatures, e.g., 110 degrees C. when being sanitized (e.g., boiled in water). Accordingly, the selected materials and bonding agents used to fabricate the pacifier  10  are able to withstand such temperature swings and sustain the water-tight, malleable and biocompatible characteristics throughout the life expectancy of the pacifier  10 . 
     Prior to use, the pacifier  10  is stored in a freezer or other temperature controlled environment in order to cool the cooling mediums to a desired temperature. The pacifier is then inserted in the child&#39;s mouth when the child is feeling irritable or experiencing pain from teething. Advantageously, the adjacently positioned or nested arrangement of the dual chambers  26 ,  30  in the nipple  14  enables the cooling medium in the outer chamber  30  to maintain the desired cooling temperature for longer periods of time when the pacifier  10  is inserted in the child&#39;s mouth, as compared to the prior art pacifiers with nipples having a single chamber filled with a coolant substance therein. During use, the nipple  14  can be positioned to maximize contact and cool selected oral tissues, e.g., the gums within the child&#39;s mouth. The first cooling medium  34  transfers heat from the oral tissue of the child to the colder inner cooling medium  36  to thereby keep the oral tissues colder for longer periods of time during use. 
     Preferably, the first cooling medium  34  is maintained at a temperature of approximately 0 degrees C. to approximately 5 degrees C. The cooling mediums  34 ,  36  are carried by the device in the sealed chambers  26 ,  30 , and the device is cooled in a freezer or other cooling device to the proper temperature prior to use. The cooling medium may be a non-toxic gel or a like substance made by adding, for example, hydroxyethyl cellulose (CELLUSIZE™), sodium polyacrylate, or vinyl-coated silica gel that can maintain its initial temperature. 
     In one embodiment, the material used for the surfaces of the pacifier can be somewhat more rigid than the flexible surface forming the outer shell  24  to increase durability and better maintain the desired shape of the other pacifier components during use. In any of the embodiments, the materials used to fabricate the pacifier  10  are selected to be sufficiently durable and suitable to maintain a water-tight seal during use by a child. Moreover, the selected materials are able to withstand external forces that may be applied to the pacifier, such as when the child bites down on the pacifier, and the like. Illustratively, a metallic mesh material can be embedded within the external surfaces to prevent puncturing or other possible damage that could cause a leak to occur. In any event, should a leak occur, there is no harm to the patient because the contents are non-toxic and preferably include water, salt, and/or other harmless, non-toxic substances. As well, a person of ordinary skill in the art will appreciate that the pacifier  10  can be manufactured in a variety of sizes to accommodate different mouth cavity sizes for children of various ages, i.e., generally ranging from 6 months to two years. 
     In yet another embodiment, one or more breathing tubes  72  can be formed through the upper surface  54  of the shield  50  and extend through the inner shell  28  and the distal end  40  of the outer shell  24 , as illustratively shown by the pair of lines drawn in phantom in  FIG. 2 . The breathing tube  72  as a first opening  74  illustratively formed at the center of the shield  50  and a second opening  76  formed in the distal end  40  of the outer shell  24  along the longitudinal axis L. The breathing tube  72  is preferably formed as cylindrical straw to enable breathing through the nipple  14  via the child&#39;s mouth. A person of ordinary skill in the art will appreciate that the shape and positioning of the breathing tube  72  through the shield  50  and nipple  14  as shown in  FIG. 2  is not considered limiting. 
     In still another embodiment, the first and second cooling mediums  34 ,  36  can be manually filled into the outer and inner shells  24 ,  28 , respectively of the pacifier  10  by the caretaker. Referring to  FIG. 1 , a first port  80 - 1  is formed through the shield  50  at a position aligned over the outer chamber  26  and a second port  80 - 2  is formed through the shield  50  at a position aligned over the inner chamber  30 . The ports  80 - 1 ,  80 - 2  (collectively ports  80 ) serve as inlets/outlets for manually filling and emptying the chambers  26 ,  30 . Each port  80  includes a seal  82  (e.g., cap, plug and the like, see  FIG. 2 ), which can be manually opened/closed (e.g., removed/reinserted) in the ports  80 . In an alternative embodiment, the first port  80  and corresponding seal  82  can be positioned in a tubular (hollow) handle  18  to enable the filling/emptying of the first cooling medium  34  into the outer chamber  26 . A person of ordinary skill in the art will appreciate that the number and positioning of the coolant ports  80  is not considered limiting. For example, the handle  18  can be an asymmetrically-shaped, tubular (hollow) handle with one end attached to the shield  50  at a position that is aligned over the outer chamber  26  as illustratively shown in  FIGS. 2 and 3 , and an opposing second end of the tubular handle  18  attached to the shield  50  at a position that is aligned over the inner chamber  30  (second handle end positioning not shown). Each end of the tubular handle includes an inlet  80  with a seal  82  to enable manual filling/emptying of the inner and outer chambers  26 ,  30  with the first and second cooling mediums  34 ,  36 , respectively. 
     In still another embodiment, the cap  56  can be unthreaded from the shield  50  to expose the upper portions of the outer and inner chambers  26 ,  30  proximate their respective flanges  46 ,  48 . The first and second cooling mediums  34 ,  36  can be manually poured into the chambers  26 ,  30 , and the cap  56  is then slid over the outer shell  24  and threaded back onto the shield  50  to close off and seal the chambers  26 ,  30 . In any of the refillable outer/inner chamber embodiments, the contents of the outer and inner chambers  26 ,  30  can be replenished with fresh first and second cooling mediums  34 ,  36 , as deemed necessary by the caretaker. 
     The foregoing description of the preferred embodiment of the innovation has been presented to illustrate the principles of the innovation and not to limit the innovation to the particular embodiment illustrated. It is intended that the scope of the innovation be defined by all of the embodiments encompassed within the following claims, and their equivalents.