RU2808477C2 - Pacifier for training the correct position of the tongue - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: pacifier consisting of a handle, a shield having an upper curved portion that curves inward toward the handle and configured to receive the nose of an individual, and a lower portion, a nipple inclined downward from the shield, having an upper portion including a raised portion that extends toward shield, and a lower part, including a convex side, and the lower part is spaced apart from the solid shield further than the raised part, the ledge.

EFFECT: providing an intraoral device that encourages an infant to maintain regular rows of primary teeth while avoiding orthodontic complications and sleep problems that can negatively affect the infant's current health and future well-being.

24 cl, 6 dwg

Description

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit from Provisional Application No. 62/776191, entitled "A Pacifier to Train Proper Tongue Position", filed December 6, 2018, the disclosure of which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The present invention relates to an intraoral device and method for maintaining correct dentition in a child. More specifically, the present invention relates to one or more intraoral devices that can be used in place of a traditional pacifier, thereby preventing misdirection of a child's teeth.

BACKGROUND OF THE INVENTION

[0003] Statements in this section merely provide information of a reference nature relevant to this disclosure and should not be construed as constituting prior art.

[0004] It is common knowledge that a baby is given a pacifier as a substitute so that the baby's sucking instincts can be developed, as well as to provide temporary comfort or soothe the baby by imitating a natural nipple. However, pacifier use often becomes a habit for an infant, and when used beyond six months, the infant may have sleep problems and orthodontic complications, including dental arch defects. For example, a baby's pacifier sucking can cause pinching or narrowing of the upper jaw, often leading to a crossbite as the teeth form. Other negative effects of pacifier use include protruding upper front teeth, jaw misalignment, and problems with open closure, speech, and swallowing.

[0005] Passive use of a pacifier during the eruption of primary incisors can also cause problems, such as the development of an anterior open bite. If a primary anterior open bite is not prevented or treated, a child aged six to eight years may also develop a permanent incisal open bite and may develop, for example, abnormal, persistent problems with swallowing, breathing and/or speech. In particular, long-term pacifier use slows down the eruption of growing primary incisors because the pacifier's nipple, which passes through the front of the mouth, is thick enough to prevent the front teeth from fully erupting normally. Typically, lower primary central teeth erupt through the gum tissue between 6 and 10 months (average at 7.8 months), while upper primary central teeth typically erupt between 8 and 12 months (average at 9.6 months). Similarly, lower primary lateral teeth typically erupt through the gums at approximately 10 to 16 months (average at 11.5 months), while upper primary lateral teeth erupt between approximately 9 and 13 months (average at 12.4 months). ).

[0006] Between 14 and 18 months, the first lower primary molar typically erupts through the gum (average at 15.1 months), and the first upper primary molar erupts between 16 and 22 months (average at 18.3 months). . The lower second molar typically erupts through the gum tissue between 23 and 31 months (average at 26.0 months), while the upper second molar erupts somewhere between 25 and 33 months (average at 26.2 months). month).

[0007] For a child, the period from eighteen months to six years is critical for dental development. Often, the poor developmental pattern that has developed during this period of childhood leads to the child developing adult bite defects, which are almost impossible to correct at an older age. In addition, prolonged use of a pacifier may cause an infant to develop a narrow palate and reduce the ability to breathe through the nose, especially since the pacifier may encourage the tongue to rest in the lower arch of the mouth rather than inside the roof of the mouth. By reducing an infant's ability to breathe through their nose, pacifiers can also encourage an infant to develop a habit of open-mouth breathing, which can lead to other health problems, including an increased risk of sleep apnea and snoring. In addition, the reduced air flow through the oropharynx as a result of mouth breathing allows the tongue to be retracted posteriorly (backward), which can result in the infant's airway closing and/or reduced oxygen supply, as well as the development of swelling of the tonsils and adenoids, which further limits the infant's ability to take in proper oxygen flow. When an infant experiences decreased oxygen consumption during sleep, it negatively impacts the infant's ability to achieve REM sleep, which is critical to maintaining the health of their brain, immune and endocrine systems. Instead, the infant experiences delta sleep, which can lead to the development of serious social and behavioral problems, as well as bedwetting, infections and allergies.

[0008] Therefore, there is a need for an intraoral device that encourages an infant to maintain regular rows of primary teeth while avoiding orthodontic complications and sleep problems that can negatively affect the infant's current health and future well-being.

[0009] The present invention is intended to improve and eliminate some of these known disadvantages of the art.

SUMMARY OF THE INVENTION

[0010] The device or pacifier has a nipple angled downward to promote tongue elevation toward the roof of the mouth. It also has a ledge to accommodate the incisor primary teeth.

[0011] The same downward-facing nipple contains an inserted plastic (of a stiffer material - higher durometer hardness) that is partially inserted into the inner nipple to prevent it from moving upward as well as from moving within the teeth ledge.

[0012] The narrowed space between the downward nipple and the labial shield promotes forward growth of the mandible at an earlier age, up to approximately 20-24 months.

[0013] The lip shield, which surrounds the lips and is positioned in front of the lips and teeth, includes an animal-shaped shield as well as various other figures that encourage the baby to use and love the pacifier.

[0014] A downward-facing nipple and ledge made of a softer plastic are included in one or more embodiments and can be made in different colors and/or shiny in dark plastic.

[0015] The handle located in front of the shield has a hole for attaching the pacifier to the pajamas and preventing it from getting into the baby's throat.

[0016] A downward-pointing nipple having different sizes for different pacifier configurations, while varying pacifier sizes for different ages, discourages a child from using a pacifier.

[0017] The pacifier has features that help train the tongue to position itself correctly inside the roof of the mouth.

[0018] In one embodiment, a pacifier is provided including a shield having a first side, a second side, a top and a bottom. The handle extends from the first side and defines the longitudinal axis. The nipple emerges from the second side, the nipple being inclined relative to the longitudinal axis and extending downward from the longitudinal axis.

[0019] In another embodiment, a pacifier is provided that is configured to encourage an individual's tongue to rise toward the roof of his mouth. The pacifier includes a nipple inclined downward from a longitudinal axis extending from a front portion of the pacifier to a rear portion of the pacifier. The ledge is configured to receive an individual's incisive primary teeth.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The foregoing aspects of the present application and the manner in which they are derived will become more apparent and the teachings of the present application itself will be better understood with reference to the following description of embodiments of the present application together with the accompanying drawings in which:

[0021] in FIG. Figure 1 shows a front perspective view of the pacifier.

[0022] In FIG. Figure 2 shows a rear perspective view of the pacifier.

[0023] In FIG. 3A is a side view of one embodiment of a pacifier.

[0024] In FIG. 3B is a side view of another embodiment of a pacifier.

[0025] In FIG. Figure 4 shows a bottom view of the pacifier.

[0026] In FIG. 5 is a side view of a pacifier showing multiple layers of material.

[0027] In FIG. 6 is a top view of a pacifier showing multiple layers of material.

[0028] Like reference numerals denote like parts in multiple views. Although the examples provided herein illustrate embodiments of the present application in several forms, the embodiments disclosed below are not intended to be exhaustive or construed as limiting the scope of this application to the precise forms disclosed.

DETAILED DESCRIPTION

[0029] Although exemplary embodiments have been disclosed herein incorporating the principles of the present disclosure, the present disclosure is not limited to the disclosed embodiments. Rather, this application is intended to cover any variations, uses, or changes of the disclosure using its general principles. Moreover, this application is intended to cover such deviations from the present disclosure as are within known or common practice in the art to which this invention relates.

[0030] Commonly used pacifiers attempt to simulate breastfeeding without concern for normal tongue function, proper swallowing, proper breathing, proper position of the lower jaw in relation to the upper jaw, thumb sucking, etc. The position of the false nipple in a regular pacifier is tilted upward and the infant places his tongue under the nipple. In a breastfed baby, the soft breast presses against the roof of the mouth and promotes proper development of the upper arch. The design of a regular pacifier promotes a similar effect, but does not increase the volume of the breast. The pliable nipple may press against the roof of the mouth, but does not expand in volume like the breast, and as a result, the superior arch does not develop properly. Swallowing in this case teaches the child to place the tongue within the lower jaw, and not within the upper jaw in an elevated position, and the palate does not develop in width, which reduces nasal breathing and promotes mouth breathing. This is extremely harmful to normal development.

[0031] In the disclosed embodiments, to encourage the baby to have an elevated tongue position during swallowing, the nipple is angled downwards rather than upwards as in all other pacifiers. This increases the width of the palate, which promotes proper nasal breathing.

[0032] In addition, the use of known pacifiers can adversely affect an infant's nasal development, so attempts to discourage their use are more beneficial to the infant's proper oral development. As the baby holds the pacifier in his mouth hour after hour, every time the baby swallows, the baby's tongue is in the wrong position, ending up low in the mouth, below the pacifier's famous upward-pointing false nipple. Because the baby swallows approximately 2 times per minute for every hour the pacifier is worn, the baby learns to swallow incorrectly 120 times per hour. A baby can develop habits very easily and as a result is taught to swallow incorrectly. When the pacifier is removed from the mouth, the infant swallows by lowering the tongue and develops abnormal tongue thrusting. It is also often accompanied by an open bite and has an adverse effect on the proper eruption of the permanent incisors, which begins at approximately 6 years of age, as well as the deciduous incisors, which erupt at approximately 6 to 7 months of age.

[0033] It is also understood that the correct development of the lower jaw before the eruption of the posterior primary molars is approximately 9-16 months for the 1st primary molar (and 20-24 months for the 2nd primary molar), the occlusion is established in an anteroposterior relationship lower and upper closure and does not change after that. When an infant is born, the mandible is strongly displaced posteriorly and moves forward in most infants from the first year to the second year in the absence of posterior occlusion. Swallowing with the mouth open prevents this progressive development of the mandible, which can result in a Class II malocclusion. If the jaw is not fully developed at this early age, it usually will not develop properly after 20 months. Improper swallowing promotes more upright facial growth and increases the tendency for mouth breathing to the detriment of proper nasal breathing.

[0034] Mouth breathing at an early age increases oropharyngeal obstruction, which reduces oxygen consumption, which in turn affects the immune and endocrine systems, as well as brain function. It tends to affect growth, allergies, infections and many symptoms associated with normal behavioral and social development.

[0035] If a parent decides to give a child a pacifier, it will be important to give the child a pacifier that improves and stimulates normal oral function, which includes encouraging the correct position of the tongue high inside the roof of the mouth. This can be achieved by tilting the false nipple down rather than up to force the tongue to rise inside the roof of the mouth, which is the normal position of the tongue. This will promote proper development of the palate, which will also promote the development of nasal breathing rather than oral breathing. When the first posterior primary molars begin to emerge between 12 and 14 months of age, these molars are positioned properly within the arch. The lower jaw is forced forward into the groove between the nipple and the lower shield. A shoulder is provided to ensure proper vertical eruption of primary central incisors, which erupt at 6 to 7 months of age followed by rapid emergence of lateral incisors at 7 to 9 months of age.

[0036] These developmental pacifiers will be designed in a sequence of sizes to assist with teething, which can begin as early as 6 months of age. The first pacifier is designed to properly manage the vertical eruption of the central incisors, even if they erupt at a very early age, which can happen. Often modern pacifiers are designed using a round or oblong shaped outer shield nipple connector, which can distort proper eruption and cause the development of an open bite, which will also alter proper swallowing and tongue positioning. Therefore, in one or more of the described embodiments, a lip is included to accommodate at least the milky central ones, as well as a portion of the extremely wide side ones, when this first pacifier is used. The second pacifier, which should be used as the baby grows and the primary canines and molars erupt, contains a wider lip to guide the correct level of these teeth, as well as the continuous advancement of the lower jaw and the development of correct tongue position, which promotes increases the width of the maxillary arch and promotes normal nasal breathing. The entire purpose of these stages of the pacifier and its design is to develop normal functioning of the oral cavity, stimulate the development of the mandibular arches and their growth and, in particular, to promote normal sleep, as well as prevent sleep-disordered breathing by preventing the development of abnormal habits, which often contribute to the occurrence of these developmental anomalies due to impaired patency of the oropharynx.

[0037] The downward bevel of the nipple not only promotes an upward position of the tongue within the palate, so that when swallowing, the tongue is pressed into the palate and causes it to develop proper palate width, which increases nasal space for increased nasal breathing. The outer shield is also solid, without holes, in order to interfere with breathing through the mouth. The forward position of the mandible promotes proper growth, which prevents retrognathia of the mandible with narrowing of the airways.

[0038] Each successive pacifier designed for older pacifiers is reduced in size to discourage the need for a pacifier and gradually changes its shape and design in accordance with the characteristics of the device designed to eliminate all abnormal habits and promote proper breathing, development of a normally functioning oral cavity. These sequential and gradually changing series of pacifiers prevent abnormal development and promote proper functioning of nasal breathing, swallowing, dentition growth and development (without a narrow upper arch), as well as mandibular development and the prevention of extreme facial development in open bites and undesirable jaw relationships and teeth.

[0039] A gradually changing series of sequential pacifiers includes one or more of the following advantages: Correct anteroposterior and lateral development of the superior arch; Promotes proper nasal breathing; Prevents breathing through the mouth; Helps correct sleep disordered breathing; Improves the position of the tongue inside the palate; Prevents open bite; Prevents tongue thrusting; Prevents improper swallowing habits; Prevents thumb or finger sucking; Promotes proper growth of the lower jaw, which eliminates the typical excessive horizontal overlap of the infant's dentition; Prevents long face syndrome (increased facial height); supports and/or improves immune, endocrine symptoms and brain function; supports and/or improves speech; Controls the eruption of all primary teeth into their normal relative position; and Encourages the infant to stop using a pacifier.

[0040] In one or more embodiments, the nipple is angled downward to promote tongue elevation to the roof of the mouth, or the pacifier is made of two materials, one of which contains a relatively rigid material, such as polypropylene, and the second, a soft, flexible material, such as silicone or thermoplastic elastomer (TPE).

[0041] The polypropylene material fits into the lip, which limits curvature, and even into the nipple, in some embodiments, to prevent the nipple from bending upward, thereby preventing the baby from getting his tongue under the nipple. In one manufacturing method, the pacifier is made in an initial configuration from polypropylene, and silicone or TPE is applied to the polypropylene in a second process that involves bonding to the polypropylene.

[0042] Because the polypropylene is contained within the shoulder and nipple, this prevents the two materials from delaminating.

[0043] The downward tilt of the nipple also has another purpose - moving the lower jaw forward, which enhances its growth in the anterior direction, especially before the establishment of a posterior bite with the eruption of the 1st primary molar. Such eruption can produce a significant vertical force on the jaws, which during chewing stabilizes the intercuspation and prevents the mandible from moving anteriorly (forward) faster than the maxilla.

[0044] The shoulder that controls the eruption of the incisors at 5 to 6 months of age is wide enough to accommodate these upper and lower incisors. This eruption-controlling shoulder can be extended back around the arch to control the eruption of the deciduous canines and molars (1st and 2nd deciduous teeth). These teeth erupt from about 9 months to 24 months (or even up to 30 months).

[0045] Currently known pacifiers are designed to accommodate a child's growing baby teeth and at the same time to gradually eliminate bad habits that are acquired with conventional existing pacifiers. As a result, the second pacifier device has a smaller nipple, which discourages its use by infants approximately 6 months of age and older.

[0046] The third pacifier has the nipple removed along with the shield that was on the outside above the lips, now located inside the mouth in front of the baby teeth between the incisors and lips. The third pacifier is configured to further prevent or reduce pathological symptoms such as narrow palate, decreased nasal breathing, sucking habits, mouth breathing, open bites and/or abnormal swallowing.

[0047] The lip remains in the third pacifier, but is deflected downward by the tongue toward the position of the dentition to assist in keeping the tongue elevated in the oral cavity. The inclined ledge stimulates and continues to apply a transverse force within the palate to provide expansion of the palate to enhance nasal breathing.

[0048] The space from the downward-sloping nipple and the bottom of the shield is relatively narrow, making it uncomfortable for the tongue, which encourages the tongue to rest in the roof of the mouth.

[0049] Also attached is a handle that extends between the lips towards the outside of the mouth. This handle is designed to ensure that the device is wide enough so that air cannot be sucked into it. Another reason for this pen is the ability to attach it to your nightgown while you sleep. It also serves as an exercise handle so that the patient can pull it forward from the lips to strengthen the orbicularis oris muscle and help strengthen as well as lengthen the lips.

[0050] Each of the described pacifier embodiments is intended to change the habit of holding the tongue in a downward (low) position, which occurs due to the upward angled artificial nipple that is angled upward on known pacifiers. Each of the pacifiers described is also designed to change the habit of holding the tongue in the lower (low) position, which leads to filling of the upward tilted nipples used in bottle feeding. What happens in these cases is that the use of the known pacifier is facilitated by its design. Such use may last from several hours a day or even at night for a period of several months to several years. Because a child swallows twice per minute during the day and once per minute at night, this has a very strong impact on how the child learns to swallow. This not only stimulates tongue thrusting and abnormal “backward” or thrusting swallowing, but also promotes an anterior open bite.

[0051] In FIG. 1 illustrates one embodiment of a pacifier 10 of the present invention for use by a child from birth to approximately six months of age. Although the age of the child is stated here, it is provided as a guide and is not intended to be limiting in any way. These uses are considered recommendations and other uses are considered.

[0052] The pacifier 10 includes a downwardly inclined nipple 12 that causes the tongue to rise to its proper position. See also Fig. 2 and 3. During swallowing, nipple 12 trains the tongue to press against the roof of the mouth and expand, creating the vacuum necessary for swallowing. As a result, the child's (or patient's) tongue expands and presses on the palate and alveolar ridges in an outer or lateral direction, causing the palate to expand. This in turn enhances nasal breathing, which is the normal way of breathing. The pacifier 10 includes a shield 14 having an upper portion 16 and a lower portion 18 to which a nipple 12 is attached. In one embodiment, the shield 14 is solid and has no holes or holes, thereby reducing the child's ability to breathe through the mouth.

[0053] As seen in FIG. 3, the nipple 12 is inclined downward from the longitudinal axis 15. The front surface 17 of the nipple 12 is inclined relative to the longitudinal axis 15, indicating that the nipple 12 is inclined downward. The downward inclination angle 19 is typically between 30 and 90 degrees. In one example embodiment, the angle is 65 degrees, as shown in FIG. 5.

[0054] A laterally extending shoulder 20 extends lateral to the first side 22 of the scute 14 to assist the eruption of various teeth that enter the oral cavity at different stages of development. In different embodiments, the shoulder widths vary. The ledge 20 is connected to the nipple 12 and the shield 14 and is located between them. The devices (pacifiers 10) shown in the illustrations in FIGS. 1, 2 and 3 are designed to accept at least two primary central incisors, as well as lateral ones in children who are much older. For older children (6-12 or 15 months), a ledge 20 extends around the arch to assist the eruption of the primary canines, 1st and 2nd molars (upper and lower) (deciduous), which erupt from approximately 10 to 30 months , usually between 12 and 24 months of age, for example as shown in FIG. 4.

[0055] The handle 24 is connected to and extends from the second side 26 of the shield 14. In one or more embodiments, the handle 24 includes a hole or hole 28 configured to connect to a connector, such as a clasp, for attachment to a child's clothing, which may reduce the likelihood that the child will misplace the pacifier. In one or more embodiments, the handle 24 includes one or more projections 30 (see FIG. 3) to prevent the child's fingers from slipping when gripping the handle 14, which also prevent the user's hand from sliding along the handle.

0056] The upper portion 16 of the shield 14 includes a curved portion 32 having an edge that curves inward toward the handle 24 to ensure that the pacifier 10 is positioned in the correct orientation during use. The lower portion 18 includes a curved portion 34 having an edge that curves outward from the handle 24. The curved portion 32 of the shield 14 is configured to accommodate an infant's nose. The shield 14 in various embodiments is manufactured in different sizes to accommodate different face sizes as the child ages.

[0057] As shown further in FIG. 2, nipple 12 includes a concave side 40 and a convex side 42, wherein the convex side 42 includes one or more projections 44 (see FIGS. 3 and 4). In one embodiment, as shown in FIG. 3, three projections or “bulges” 44 are located on the convex side 42. Other projection configurations are provided. The projections are located on the convex side 42 to distinguish the convex side 42 from the concave side 40 for the child. Since the projections are only on one side, the baby's tongue is directed towards the concave side 40.

[0058] The first side 22 of the shield 14 contains a concave surface, which is concave in the same direction as the concave side 40 of the nipple 12. The second side 26 of the shield is convex. By shaping the first side 22 into a convex surface, the shield is adapted to interact with the child's cheeks and teeth on the upper and lower jaw.

[0059] Nipple 12 includes a curved lower portion 46 and a relatively flat upper portion 48. The upper portion 48 defines a raised portion 49 relative to the relatively flat surface 50 of the shoulder 20. As seen in FIG. 2, the channel or channel 50 includes a flat portion that is located between the flat top portion 48 and the first side 22 of the shield 14 configured to accommodate a child's gums and/or teeth. As can be seen in FIG. 2, trough 50 has a length of 52 and a width of 54. In the embodiment shown in FIG. 1 and 2, the width 54 of the trough 50 is substantially equal to the width of the nipple 12. In another embodiment, as shown further in FIG. 4, the width of the ledge is wider than the width of the nipple 10.

[0060] In FIG. 3A shows an exemplary embodiment of a pacifier for a child aged 0 to 6 months. In one embodiment, the height H of the shield is approximately 1.5 inches. The length L of handle 24 is approximately 0.8 inches. The thickness T of handle 24 is approximately 0.115 inches. In various embodiments, handle 24, as shown in FIG. 3B has various configurations, each of which imitates part of an animal or part of other animate or inanimate figures. Examples of such parts include the wings, noses and ears of various animals. In one embodiment, the handle 24 is shaped like an elephant's trunk 25. In one or more embodiments, the handle, formed in the shape of an animal part, includes an opening 27 for securing a cord or rope attached to the user's nightgown or pajamas.

[0061] In FIG. 4, 5, and 6 show another embodiment of a pacifier 60 for a child aged 6 to 13 months. This is the second pacifier in the range of pacifiers described herein in which certain elements are changed from those of a first age group pacifier to elements of a second age group pacifier. Using pacifiers in stages, the baby is provided with pacifiers as he grows up. In this age range of 6 to 13 months, the pacifier is configured to assist the eruption of primary teeth, namely the upper and lower primary incisors, which erupt between 6 and 13 months of age. In this embodiment, the pacifier 60 includes a handle 61 and a shoulder 62 of width W _s that is wider than the shoulder 20 of the 0-6 month device shown in FIG. 1, 2 and 3. The shoulder has an opening 63. In one embodiment, the increase in width is about 43%. In other embodiments, the width increase range is from 20% to 60%. Shield 64 is operatively coupled to shoulder 62. In the exemplary embodiment shown in FIG. 4, shoulder 62 is approximately 0.25 inches wider than shoulder 20 in FIG. 1. The width of the nipple 82 includes a width W _N that is less than the width W _s . The nipple 82 includes one or more projections 65. As seen in FIG. 6, layer 67 of thermoplastic elastomer 69 has a thickness T _E of about 0.08 inches. Other thicknesses are also possible.

[0062] The length L _N of the nipple in the embodiment shown in FIG. 3, which is intended for a 0 to 6 month baby, is reduced by about 0.15 inches (from 0.72 inches to 0.58 inches) in the embodiment shown in FIG. 4. Finally, the opened pacifier shown in FIG. 4, is designed to adapt to changes in growth and the eruption of primary teeth during the first two years of life. One of the main intentions of the present invention is to gradually reduce the size of the nipple so that it becomes smaller as the child grows older. In this way, the baby gradually gets used to each subsequent smaller pacifier until it is no longer present in subsequent versions of the pacifier. While the size of the nipple decreases, i.e. becomes smaller in length or width, or both, the scutum correspondingly becomes larger to accommodate larger jaws as the child grows older.

[0063] The first pacifier is used from birth to 6 months of age. The second pacifier is modified from the 0 to 6 month device to be used comfortably by infants aged 6 to 12 or 15 months. The downward sloping nipple shown in FIG. 5 is approximately 21% shorter in one embodiment compared to the embodiment shown in FIG. 3. In various embodiments, the length reduction ranges from 10% to 30%. Nipple 82 in FIG. 5 has a thickness T _N that is approximately 34% smaller in thickness compared to the nipple in FIG. 3. Reducing the thickness of the pacifier makes the pacifier less comfortable, continue to prevent the infant from trying to move the nipple to the up position. The nipple 82 has a length N _L , which in one embodiment is approximately 0.6 inches in length. The shoulder 62 has a thickness S _T , which in one embodiment is 0.26 inches. The height N _H of the nipple relative to the longitudinal line 67 in one embodiment is 0.55 inches. N _L length is about 1.5 inches. Other sizes of nipple elements are possible 60.

[0064] Shield 64 of the embodiment shown in FIG. 4 is made wider than the pacifier for children from 0 to 6 months by approximately 15%, and in height by approximately 25%. This increase is intended to adapt to the size of the child's face and to further prevent mouth breathing and promote nasal breathing.

[0065] In FIG. 5 and shows the second embodiment shown in FIG. 3, comprising a core 70 having a core shoulder 72, a core handle 74, and a core shield 76. The embodiments in FIGS. 1, 2 and 3 contain a similar design. In this embodiment, the core 70 is made of a harder plastic, such as polypropylene, or other materials having a higher durometer hardness. The core 70 is covered with an outer layer 80 formed from a softer material such as thermoplastic elastomer (TPE), thermoplastic rubber, silicone resin or rubber. Core shoulder 74 extends as part of shoulder 62 shown in FIG. 4 to provide stability to the shoulder and prevent movement of the nipple 82 shown in FIG. 4 and Fig. 5. As shown in FIG. 5, the nipple 82 82 is mainly formed from a softer material. However, other embodiments are possible in which the core 70 includes elements extending into the nipple 82, including those that are inclined relative to the shoulder 72 of the core. The core shoulder 72 provides a certain amount of rigidity to the nipple 82, which keeps the nipple 82 in a relatively stationary position, especially if the baby has to stick its tongue under the nipple to try to lift the nipple. If this rigidity is reduced, then the nipple's task of raising the tongue will decrease or essentially disappear. The nipple 82 includes a plurality of projections or projections 84 located on the convex side 86.

[0066] Core 70, i.e. a polypropylene insert within shoulder 62 provides a shoulder that is wider than shoulder 20 in FIG. 1 by approximately 44% or approximately 16 mm to 23 mm. This wider shoulder is designed to accommodate wider than normal primary incisors, particularly the upper central and lateral incisors, which can reach a width of 26.7 mm, while the shoulder 62 is 23 mm.

[0067] As described herein, two or more pacifiers are designed to accommodate a child's growth patterns from infancy 0 to a child 24 months of age or older. The first pacifier in the series of pacifiers is usually intended for children aged 0 to 6 months. The second pacifier in the pacifier series is usually designed for babies between 6 and 12 months of age. Additional pacifiers are designed for subsequent age groups, for example from 13 months to 18 months and from 19 months to 24 months. With each subsequent pacifier, the nipple becomes smaller compared to the previous age group pacifier, and the lip becomes wider compared to the previous age group pacifier. Pacifiers are sold as individual pacifiers, indicating the appropriate age group for which the pacifier is intended. In other embodiments, the first two or first three pacifiers are sold together in one package to provide for an older child.

[0068] Additional devices for the 1 to 4 year age group, the 4 to 6 year age group, and the 7 to 12 year age group (or 6 to 12 years depending on the maturity and height of the individual) can be seen in US Patent No. D722171, entitled Oral Appliance, issued February 3, 2015, which is incorporated herein by reference in its entirety.

[0069] Although exemplary embodiments have been disclosed herein incorporating the principles of the present disclosure, the present disclosure is not limited to the disclosed embodiments. Rather, this application is intended to cover any variations, uses, or changes of the disclosure using its general principles. Moreover, this application is intended to cover such deviations from the present disclosure as are within known or common practice in the art to which this invention relates.

Claims (44)

1. A pacifier for an individual, comprising: a handle, a continuous shield configured to inhibit mouth breathing and promote proper nasal breathing, wherein the solid shield is connected to the handle, wherein the solid shield includes a continuous outer edge starting at an upper portion located above handles and extending through a lower portion located below the handle and back to the upper portion, the solid shield including an upper curved portion that curves inward toward the handle and configured to receive the nose of an individual, and a lower curved portion that curves outward from the handle; a nipple connected to a solid shield, wherein the nipple slopes downwardly and extends from the continuous shield to elevate the tongue of an individual, wherein the nipple includes an upper portion and a lower portion spaced from the upper portion, wherein the upper portion of the nipple includes a raised portion that extends toward the continuous shield and the lower portion includes a convex side, the lower portion being spaced further from the solid shield than the raised portion is spaced from the solid shield, and wherein, in a side view of the front surface of the nipple, the front surface is flat; a ledge extending from a raised portion of the nipple to a solid shield, the ledge, in a top view of the ledge, including a flat surface free of projections, and the ledge including a groove including a flat portion that extends between a lower portion of the nipple and the continuous shield, wherein the convex side of the lower the nipple portion is configured to extend the individual's lower jaw toward the flat portion of the groove, and further, the shoulder is configured to provide proper vertical eruption of both the individual's upper and lower deciduous incisors. 2. The pacifier according to claim 1, in which the convex side includes protrusions. 3. The pacifier according to claim 2, in which the flat surface of the ledge is coplanar with the flat part of the gutter. 4. The pacifier according to claim 3, in which the handle forms a longitudinal axis and the flat surface of the ledge is parallel to the longitudinal axis. 5. The pacifier according to claim 4, in which the ledge includes a first transverse width perpendicular to the longitudinal axis, and the nipple includes a second transverse width parallel to the first transverse width, wherein the first transverse width and the second transverse width are equal in width or have different width. 6. The pacifier according to claim 5, in which the front surface of the nipple is concave. 7. The pacifier according to claim 6, wherein the handle includes one or more projections configured to prevent sliding movement of the user's hand along the handle. 8. The pacifier according to claim 7, wherein the pacifier contains a core and an outer layer located on the core. 9. The pacifier according to claim 8, wherein the core is formed from a first material and the outer layer is formed from a second material, the second material being softer than the first material. 10. The pacifier according to claim 1, wherein the groove prevents the lower jaw and tongue from moving backward to prevent collision with the pharynx, so that the pharynx remains open during sleep. 11. A pacifier for an individual, comprising: handle; a continuous flap connected to the handle, the solid flap including a continuous outer edge beginning at an upper curved portion vertically located above the handle and extending through a lower curved portion vertically located below the handle and back to the upper curved portion, configured to inhibit mouth breathing and promoting proper nasal breathing, the upper curved portion being curved inward toward the handle and configured to receive the nose of an individual; a nipple inclined downward from the solid shield and configured to elevate the tongue of an individual, the nipple being configured to gradually decrease the sucking habit as the individual grows, and further wherein the nipple includes an upper portion and a lower portion spaced apart from the upper portion, wherein the upper portion includes a raised portion that extends in the direction of the solid flap, and the lower portion includes a convex side, wherein the lower portion is spaced apart from the solid flap further than the raised portion is spaced from the solid flap, and wherein, in a side view of the front surface, the front surface the nipple is flat; And a shoulder extending between the solid shield and the nipple, wherein the shoulder, in the top view of the shoulder, includes a flat upper surface free of projections, and the shoulder includes a flat lower surface coplanar with the flat upper surface, wherein the shoulder provides proper vertical cutting of both the upper and lower the individual's deciduous incisors, and furthermore, the shoulder includes a width selected to accommodate erupting teeth of different sizes. 12. The pacifier according to claim 11, in which the width of the ledge is the same as the width of the nipple. 13. The pacifier according to claim 12, in which the handle forms a longitudinal axis, and the width of the flat surface is perpendicular to this longitudinal axis. 14. The pacifier of claim 11, wherein the flat surface includes a first transverse width perpendicular to the longitudinal axis, and the nipple includes a second transverse width parallel to the first transverse width, wherein the first transverse width and the second transverse width have different widths. 15. The pacifier according to claim 14, wherein the first transverse width is greater than the second transverse width. 16. The pacifier of claim 11, wherein the raised portion and the intersection of the convex side of the nipple and the flat bottom surface causes the subject's lower jaw to advance toward the flat bottom surface to advance the lower jaw relative to the upper jaw. 17. A pacifier for an individual, comprising: handle; a shield having a first side connected to the handle and a second side opposite the first side, the shield having an upper curved portion that is curved inward toward the handle configured to receive the nose of an individual, and a lower curved portion connected to the upper curved portion; a downwardly angled nipple coupled to a second side of the shield, the downwardly angled nipple angled downwardly and away from the second side of the shield, the nipple including an upper portion spaced from a lower portion, the upper portion of the nipple including a raised portion that extends toward the shield, and the lower portion includes a convex side, wherein the lower portion is spaced apart from the solid shield further than the raised portion is spaced from the shield, and wherein, in a side view of the front surface of the nipple, the front surface of the nipple is flat; And a ledge located between the shield and the raised part of the nipple; And a core disposed within the nipple, shoulder, and handle, wherein the core extends from the nipple, through the shoulder, and into the handle, wherein the handle extends from a first side of the shield and the shoulder extends from a second side of the shield, and wherein the core is formed from a first material having a higher hardness according to durometer than the second material forming the nipple. 18. The pacifier of claim 17, wherein the handle includes one or more projections configured to inhibit sliding movement of the user's hand along the handle. 19. A pacifier for an individual, comprising: handle; a shield having a first side connected to the handle and a second side opposite the first side, the shield having an upper curved portion that is curved inward toward the handle configured to receive the nose of an individual, and a lower curved portion connected to the upper curved portion; a downwardly angled nipple coupled to a second side of the shield, the downwardly angled nipple angled downwardly and away from the second side of the shield, the nipple including an upper portion spaced from a lower portion, the upper portion of the nipple including a raised portion that extends toward the shield, and the lower portion includes a convex side, the lower portion being spaced further from the solid shield than the raised portion is spaced from the shield, and wherein, in a side view of the front surface of the nipple, the front surface is flat; a ledge located between the shield and the raised part of the nipple; And a core disposed within the ledge, the core extending from the nipple to the ledge, the handle including one or more projections configured to inhibit sliding movement of a user's hand along the handle; And in this case, the core passes through the nipple, ledge and handle. 20. The pacifier of claim 19, further comprising an outer layer disposed on a core, the core being formed from a first material and the outer layer being formed from a second material different from the first material. 21. A pacifier comprising: a handle extending from the shield and configured to cause the individual's tongue to rise towards the roof of his mouth, the pacifier comprising: a shield having a first side, a second side, an upper portion, and a lower portion, the upper portion being curved inward toward a handle configured to receive the nose of an individual; a nipple angled downward from a longitudinal axis extending from a front portion of the pacifier to a rear portion of the pacifier, the nipple including an upper portion defining a raised portion, a lower portion spaced from the upper portion, and a front surface facing the mouth of the individual , wherein the front surface has a downward slope angled relative to the longitudinal axis and located between the upper part and the lower part, the lower part being spaced further from the shield than the upper part is spaced from the shield, and wherein, in a side view of the front surface, the front surface is flat; And a ledge having a first end and a second end terminating at the shield, the first end being operatively connected to the raised portion, the ledge extending from the raised portion in a direction of the shield, the ledge including a flat surface, the raised portion being elevated relative to the flat surface, and the flat the surface is continuously flat from the raised portion to the second end, wherein the upper portion of the nipple extends toward the shield and is connected to the raised portion of the shoulder, and wherein the shoulder is configured to receive the incisal primary teeth of an individual. 22. The pacifier according to claim 21, wherein the nipple includes the width of the nipple, and the ledge includes the width of the ledge, and the width of the nipple is equal to the width of the ledge or less than the width of the ledge. 23. The pacifier according to claim 22, wherein the pacifier comprises a core and an outer layer located on the core. 24. The pacifier of claim 23, wherein the core is formed from a first material and the outer layer is formed from a second material, the second material being softer than the first material.

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