Patent Application
20220008244
The present invention relates to a therapeutic oral appliance. More specifically, it relates to an upper and lower oral appliance having protuberances modeled after naturally occurring oral topographical elements called Tori. These protuberances cause gentle irritation of nerves innervating the dorsum and lateral surfaces of the tongue, thereby affecting forward re-positioning of the tongue. Such positioning provides a number of health benefits including improved air intake into the bronchial pathways, improved muscle tone, and reduced bruxism. A method is also provided for bonding protuberances to pre-existing oral appliances. The invention will be appreciated by athletes, people suffering from sleep disorders, speech therapy patients, and people who grind their teeth regularly.
Dental Tori are naturally occurring bumps or mounds that grow inside the mouth. These bumps are the result of bone cell deposit accumulation on specific surfaces of the oral cavity. Mandibular Tori (Tori Mandibularis) are bone growths on the lower jaw and generally occur on the anterior lingual surfaces of the mandible, near the pre-molars. In most cases, mandibular Tori are present on both sides of the mandible (left and right), though they need not be symmetrical in size or shape. Palatial Tori (Tori Palatinus) are bone growths generally occurring on the hard palate. These bumps tend to grow along the midline or anterior edges of a patient's hard palate region. They may be flat, ridged, or nodular ins shape. A third type of Tori, Buccal Tori (Buccal Exostosis) form behind the molars near the mandibular hinge. Tori are a benign and painless condition and do not generally require surgical removal unless they interfere with the use of medically necessary oral appliances such as dentures.
Though the Tori condition itself is non-threatening, the underlying causes of Tori growth may warrant medical treatment. Local stress on the jaw can initiate or increase the deposit of bone material along the surfaces of the oral cavity. Teeth grinding, known as bruxism causes repeated stress and tension to the musculoskeletal structures of the jaw. As the patient grinds his or her teeth, force is exerted in multiple directions, wearing down the teeth and causing muscle damage. If bruxism continues over a substantial period of time, the patient can suffer serious bone loss, cracked teeth, muscle dysfunction, and other health problems. Often, the symptoms are treated via the use of pain medications, muscle therapies, and nighttime oral appliances that protect the teeth and absorb shock. Treatment of the causes of bruxism can be difficult without further testing to determine whether the grinding is a result of anxiety and stress in the user's life, or if a breathing disorder such as sleep apnea is a factor.
Sleep disorders, such as obstructive sleep apnea (OSA), are strongly linked to night and daytime bruxism. Sufferers of OSA are particularly susceptible to grinding and gnashing their teeth during apnea episodes and the stress and fatigued resulting from disrupted sleep can lead to daytime grinding. OSA is a disorder in which a sleeper's breathing is interrupted by the whole or partial collapse of the pharyngeal airway of the throat. During pharyngeal constriction, breathing may be shallow or may cease all together. Abnormal breathing can last for ten seconds to several minutes. Patients may snore, make choking noises, grind their teeth or have small spasms as they try to breathe. Over time, untreated apnea can lead to the health problems associated with bruxism, heart disease, high blood pressure, stroke, memory loss, and other forms of brain damage. Treatments for obstructive sleep apnea include oral appliances that open up the mouth to allow air flow, oxygen masks that force air into the throat (continuous positive airway pressure), and lifestyle changes including dietary changes and exercise.
Oral appliances currently used in the treatment of obstructive sleep apnea or bruxism are designed to prevent the teeth from connecting, forcing the mandible forward and maintaining an opening in the mouth. This mandibular repositioning maintains the pharynx passageway in an open state, permitting continuous airflow through the passageways of the throat. While these appliances may be helpful to some patients, they physically reposition the mandible without requiring any active participation by the patient's orofacial muscles. Thus, the muscles are not actually strengthened, but are merely stretched. Proper muscle tone and strengthening could reduce frequency of apnea episodes and increase the pharynx's ability to maintain dilation without mechanical support.
Flexing tongue musculature can manipulate pharynx opening size without mandible movement. The tongue has four intrinsic muscles, responsible for shaping and flexing the tongue, and four extrinsic muscles, responsible for moving the tongue within the oral cavity. Intrinsic tongue muscles are located within and along the top and margins of the tongue. Extrinsic muscles extend from a structure outside the tongue to an area within. These exterior muscles are the genioglossus, the hypoglossus, the styloglossus, and the palatioglosus. The Genioglossus extends from the mental spine of the mandible and inserts within the tongue structure along the inferior and lateral portions of the tongue. It is responsible for tongue protrusion and depression. Similarly, the hypoglossus is also responsible for depression and protrusion or retraction of the tongue. The hypoglossus extends from the great horn of the hyoid bone in the neck to the inferior and lateral surfaces of the tongue. The styloglossus muscle extends from the styloid and stylohyoid ligament into the lateral and inferior portions of the tongue. The styloglossus assists in retraction of the tongue. Lastly, the palatoglossus extends from the Palatine Aponeurosis to lateral portions of the tongue and is responsible for affecting elevation of the tongue posterior. When the genioglossus contracts, moving the tongue forward, the pharyngeal cross-section is increased. Conversely, contraction of the hypoglossus or styloglossus pulls the tongue backward into the oral cavity causing a reduction in pharyngeal cross-section.
Pharyngeal dilation can be achieved via stimulated natural tongue protrusion without mechanical repositioning of the mandible. Motor innervation for all tongue muscles comes from the hypoglossal nerve (CNXII) except for the palatoglossus, which is supplied by the pharyngeal plexus (Vagus nerve). Tongue motor function is voluntary and not regularly susceptible to reflex responses. Sensory experience of the anterior (front two-thirds) of the tongue is supplied by a branch of the trigeminal nerve (V3) known as the lingual nerve. The hypoglossal nerve and lingual nerve are in communication along the anterior border of the hypoglossal muscle. Thus, stimulation of the lingual nerve across different portions of the tongue surface can be translated to the hypoglossal nerve and affect voluntary motor function of the extrinsic muscle structures. Electrical stimulation of the genioglossus insertion into the tongue has been shown to manipulate pharyngeal cross-section size. Stimulation across the anterior portions produces genioglossus contraction and forward tongue protrusion, while stimulation of posterior areas results in bunching of the posterior tongue that constricts pharyngeal diameter. Though useful in clinical settings, electrical stimulation of a user's oral cavity during sleep or while engaging in athletics would be cumbersome if not outright dangerous. An oral appliance is needed that employs targeted physical stimulation of the tongue surface to affect dilation of the airways of the throat and improve muscle strength.
The present invention is a soft, flexible oral appliance having upper and lower mouthpieces that may be used in conjunction or independently. The upper mouthpiece has a teeth trough extending across the entire set of upper teeth, and a partial palatial surface extending from the lingual surface of the trough. Three sets of nodular protuberances are disposed along the palatial surface; two sets located at premolars on laterally opposing sides of the palatial surface, and one larger protuberance centrally located at an area behind the two front teeth. The lower mouthpiece has a pair of troughs extending over the mandibular molars. A facial bridge section joins the two troughs together. The lingual surfaces of each trough have a mandibular surface extending down over the mandible. Sets of nodular protuberances are disposed on these mandibular surfaces. Both the protuberances of the upper mouthpiece and those of the lower mouthpiece are positioned and shaped like naturally occurring nodular dental Tori. A method for adding protuberance sets to other types of oral appliances is also included as an aspect of the present invention. The prior art does not disclose a mouthpiece that includes specifically placed protuberances that stimulate surfaces of the tongue related to the genioglossus muscle. Nor does the prior art disclose a method for retrofitting oral appliances with artificial dental Tori.
Protective mouthpieces that cover the teeth and absorb shock are often used by people engaged in active and contact sports. Athletes such as hockey players, boxers, and football players universally use these mouth pieces during games, matches or scrimmages. When the user collides with another player, or an object, their teeth may clench, or be significantly jarred during impact. It is essential that the teeth are protected by a shock absorbent material, to reduce the risk of irreparable damage. Examples of such protective mouth pieces are described in U.S. Pat. No. 3,124,129 issued to M. E. Grossberg, on Mar. 10, 1964, and U.S. Pat. No. 3,496,936 issued to K. W. Gores on Feb. 24, 1970. These appliances or mouth pieces are bulky to protect the entire surface area of the teeth. Such mouth pieces are physically unattractive and prevent the user from speaking clearly and distinctly when in place. Consequently, the protective device must be continuously inserted or removed from the mouth during periods of non-contact when the user needs to speak. For example, most football players will hold the mouth piece in the mouth only during the actual time the play is progressing and are not held in place during the huddle or between plays. For non-impact sports, the present invention provides a lightweight, flexible oral appliance that allows the use to speak normally during use. The protuberances of the mouthpiece cause forward tongue protrusion and increase oxygen flow to the lungs and consequently the muscles. For impact sports requiring substantially thick mouth guards, the present invention provides a method for adding raised nodules to specific locations along the surfaces of the mouthpiece to provide irritants that will cause tongue protrusion and increase air flow while the user is playing a sport. The increase in air intake will result in higher blood oxygen content and thereby enhance performance and endurance.
As a further benefit to the present invention, recent studies indicated that controlled stress of selected muscles, such as the masticator muscles in the jaw, have a desirable cumulative effect on physical activity participants. That is, if particular selected muscles of the face can be brought to a selected tension or tonus, this tonus can affect other muscles of the body by increasing their tone and readiness for activity such that the athlete or wearer may achieve a competitive edge for a period of time.
Shock absorbent oral appliances are also useful for reducing the deleterious effects of bruxism. These devices act as a buffer between the teeth to disperse force during grinding. For example, U.S. Pat. No. 3,924,638 issued to G. E. Mann on Dec. 9, 1975, discloses two embodiments of such a tension relieving mouth appliance. Like the protective mouth pieces used in contact sports, these tension relieving mouth appliances are also readily visible when in place, and usually cause the user's speech to become slurred. Thus, these devices are not suitable for general daytime wear except during periods where articulation and clarity of speech are unnecessary. Such periods are few and far between in the average workplace, where most people experience stressful situations. At the very time an individual under formal stress may most need an appliance, the prior art devices are not suitable. The present invention solves this problem by providing a soft, flexible, shock absorbent device that can reduce the stress of teeth grinding. It is suitable for day or nighttime use because it does not impair speech patterns. Additionally, the device improves air intake into the lungs, oxygenating the blood and brain, which may assist in calming wearers during times of high anxiety or stress.
People with Temporal Mandibular Disorders (TMD) also experience regular teeth grinding episodes. Occlusal splints are frequently used to treat this type of bruxism. These splints function by overloading the periodontal receptors of two teeth in an arch thereby reflexly reducing the muscle force generated by the person experiencing TMD. An occlusal splint is a removable appliance that fits over the occlusal and incisal surfaces of the teeth in one arch creating precise occlusal contact with the teeth of the opposing arch. It is commonly referred to as a bite guard, night guard, interocclusal appliance, or orthopedic device. This type of splint typically can be used [1] to provide a more stable or functional joint position; [2] to introduce an optimum occlusal condition which reorganizes the neuromuscular reflex activity; or [3] to protect the teeth and supportive structures from abnormal forces which may create breakdown or tooth wear or both. [Okeson, “Fundamentals of Occlusion and Temporomandibular Disorders” (The C. V. Mosby Company, St. Louis, 1985), page 333]. Splint therapy has also been used for treatment of Temporomandibular Disorders [TMD].
Temporomandibular Joint Disorders [TMJ] can cause headaches, jaw clenching, and bruxism. Some headaches are related to problems with the temporal mandibular joint. It has been shown that a mouth-bite splint can be fashioned to prevent a person from clenching and realizing the various symptoms of TMJ and, in particular, soft bite guards which better absorb occlusal forces by virtue of their soft nature and aid in TMD and TMJ therapy [Lucia, “Modern Gnathological Concepts—Updated” (Quintessence Publishing Co., Inc., Chicago, 1983), page 38].
The Shore Mandibular Auto Repositioning Appliance [SMAA] can also aid in reducing the symptoms of TMJ and TMD. It was developed in approximately 1960. The SMAA frees the mandible from malocclusion and transmits the force of mandibular closure through the teeth to the maxilla thus removing pressures from the traumatized joints. To make the SMAA, a temporarily incorrect functional occlusion is created in acrylic. An acrylic-plate cast is made for the upper teeth, fitted to the person's teeth. An acrylic ramp [protuberance] approximately 3 mm thick is fabricated on the lingual aspect of the central incisors; Shore refers to the anti-occluder [protuberance] as a “ramp”]. The acrylic plate covers the palatal surface and the ramp acts as the splint [anti-occluder].
Snoring, upper airway resistance syndrome, and obstructive sleep apnea syndrome (OSAS) are all related to narrowing or obstruction of the upper airway during sleep (sleep disordered breathing). Very common symptoms in OSAS patients are morning headaches and acid reflux. During airway obstructions the forceful attempts to inspire air can cause tremendous negative pressure in the chest. These high negative pressures can draw acid up the esophagus from the stomach. The acid can travel all the way into the mouth and cause inflammation of the vocal cords and nasal mucosa. The presence of the acid in the upper airway causes reflex bronchoconstriction in the lung that is similar to an asthma attack.
Snoring occurs when the mouth is open and the tongue moves back into the throat. This causes the airway passage to narrow which increases the likelihood of snoring. It is known that moving the condyle of the lower jaw forward in a way will increase the airway and assist in the elimination of snoring.
Nocturnal tooth grinding (bruxing) is a major pain—the pressure is ten times the force registered during normal chewing. Bruxing causes the teeth to wear down at odd angles, affecting the shape of the face, causing migraine headaches and muscle soreness and aggravating TMJ disorders.
Most importantly, sleep disorders can cause serious medical disorders and death. Apneas cause a large strain on the heart and lungs. Over time the many repeated episodes of apnea cause chronic changes leading to hypertension. Long periods of apnea allow the oxygen levels in the blood to decrease. In turn the low oxygen can cause heart attack or stroke.
As discussed above, the protective oral appliances used to address teeth grinding and TMJ/TMD are bulky or physically manipulate the mandible into a forward position. Though this may assist with the dilation of the pharynx, and the prevention of teeth grinding, these devices must be removed before the user can speak, eat, or perform other activities. This can be a hassle when the user wakes in the middle of the night and needs to speak, drink water, or eat. The present invention solves this problem by providing an unobtrusive oral appliance that uses gentle irritation of the tongue to affect pharyngeal dilation, without physical repositioning of the jaw. In this way, the present invention uses natural responses to assist with bruxism and apnea relief rather than forcing the oral cavity into an unnatural position for extended periods. By encouraging the tongue to move on its own, the invention provides the benefit of increased muscle strength and tone in the face and neck.
While numerous oral appliances are known in the prior art today, none have proven to be fully effective as an everyday remedy. Major reasons for the lack of wider spread use, and hence increased effectiveness, for these appliances include the negative aesthetic appeal they carry and the impact they have on speech. The present invention offers a mouthpiece that, while learning numerous aspects from the prior art, alleviates these two major downfalls. Additionally, the present invention provides a device that does not disrupt natural jaw position, and improves air intake rather than obstructing it, as some of the prior art devices do. It substantial differs in design elements from the known types of therapeutic oral appliances and thus provides a much needed improvement in the art.
In view of the foregoing disadvantages inherent in the known types of dental mouthpieces now present in the prior art, the present invention provides a new mouthpiece wherein the same can be utilized for providing convenience for the user by alleviating numerous medical conditions, improving performance, and providing unaltered speech.
The present invention is a two-part oral appliance that reduces episodes of sleep apnea and bruxism by increasing pharyngeal dilation and strengthening local musculature. Clusters of protuberances are strategically disposed along lingual surfaces of the mouth guard. Specifically, the mandibular extensions and partial palatial surface are the only locations on the device where protuberances are located, because these surfaces cover parts of the mouth where dental Tori naturally grow. The protuberances are modeled after dental Tori, as small, smooth, rounded conical, or ridged lumps. Because Tori of these shapes and sizes are not harmful to the sensitive tissues of a patient's mouth, the artificial Tori can be used to gently guide the tongue without damaging the oral cavity. When the tongue is guided into a protruded, forward position, the airways of the throat expand in diameter, resulting in increased airflow. Pharyngeal dilation helps in preventing whole or partial collapse during respiration and thus reduces the regularity of sleep apnea episodes.
A method is also provided for adding protuberances to mouthpieces that were originally created for other uses. An orthodontic resin is mixed and then applied in mounds to areas corresponding to the rim of the hard palate and lingual mandibular surfaces. The device is then cooked to set the resin. Resin is sanded and molded into small nodular protuberances at key locations along the chosen surfaces. Though these modified oral appliances may still prevent normal speech patterns or have unaesthetic appearances, they will acquire some of the increased air intake benefits of the present oral appliance.
It is therefore an object of the present invention to provide a dental mouthpiece that can alleviate numerous the symptoms associated with night time sleep disorders.
Another object of the present invention is to provide a mouthpiece that can improve performance in athletes during daytime use by facilitating increased oxygen intake.
Yet another object of the present invention is to provide a mouthpiece that can protect the teeth, mandible, and muscles against teeth clenching in high stress situations (i.e. CPAP combination therapy).
Still another object of the present invention is to provide a two-part oral appliance having parts that can be used independently or in conjunction to reduce occurrences of sleep apnea and improve oxygen intake.
A further object of the present invention is to provide an oral appliance that mimics naturally occurring oral topographic elements to gently irritate the tongue and affect forward protrusion.
A still further object of the present invention is to provide a method for retro-fitting preexisting oral appliances with nodular protuberances that mimic naturally occurring dental Tori formations.
Other objects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings.
Although the characteristic features of this invention will be particularly pointed out in the claims, the invention itself and manner in which it may be made and used may be better understood after a review of the following description, taken in connection with the accompanying drawings wherein like numeral annotations are provided throughout.
Reference is made herein to the attached drawings. Like reference numerals are used throughout the drawings to depict like or similar elements of the therapeutic oral appliance. For the purposes of presenting a brief and clear description of the present invention, the preferred embodiment will be discussed as used for improving air intake, reducing instances of sleep apnea and bruxism. The figures are intended for representative purposes only and should not be considered to be limiting in any respect.
Referring now to
Two lateral clusters of protuberances 20 and one central protuberance 21 are disposed along the partial palatial region of the anterior lingual surface 15 of the mouthpiece to gently irritate the anterior portions of the dorsum (upper layer of the tongue). This irritation stimulates the lingual nerve near intrinsic musculature responsible for widening and flattening the tongue and near the genioglossus insertion into the lateral portions of the anterior tongue. Stimulation of lingual nerve branches is communicated to the brain and hypoglossal nerve, which then affects voluntary motor function of the nearby musculature. The wearer may experience a feeling that the tongue is “worrying” or “messing” with the protuberances. This activity causes the tongue to protrude and obtains the desired effect of increased pharyngeal cross-section.
A central protuberance 21 is located on the partial palatial region of the anterior lingual surface. As a general guide, the central protuberance is aligned between the two incisors. The central protuberance 21 is oblong, with a dorsal ridge. This shape is selected because Tori Palantinus forming along the midline of the hard palate tend to have either a large flat shape with a wide diameter, or more commonly, a sloped, ridge shape. The smooth, oblong shape of the central protuberance is thus an artificial rendering of the natural shape of midline palatial Tori. Further, the dorsal ridge Is useful in guiding the tongue forward along the midline, as opposed to a raised rounded protrusion in this area which the tongue may ignore or move around.
Three smaller, rounder protuberances forming a lateral protuberance cluster 20 are located on the partial palatial region of the left and right anterior lingual surface 15. These protuberances are conical or domed in shape, mimicking the nodular Tori that sometimes grow on the palate away from the midline. Each of the lateral clusters forms a barrier that prevents the tongue from maneuvering around the central protuberance 21. If the wear tries to move his or her tongue to either side of the central protuberance instead of moving forward, the lateral portions of the anterior dorsum will encounter a lateral protuberance cluster. This will irritate local branches of the lingual nerve, which will by communication with the hypoglossal nerve, cause the lateral intrinsic musculature to curl the margin of the tongue and force it back towards the center. In this way, the lateral protuberance clusters are guides that prevent the tongue from straying off course as it becomes irritated by the central protuberance. It is not desirable for a single elongated wall-like protuberance to replace the small, nodular protuberances, because such a large structure would likely over stimulate the lateral regions of the dorsum and affect retraction. Nodular Tori are a naturally occurring phenomenon within the mouth and in most cases do not obstruct regular tongue function. It is desirable that the protuberances of the present invention are modeled as closely as possible after small, naturally occurring shapes and dimensions of dental Tori. The specific positioning of the protuberances will depend on the topography of a patient's hard palate and tongue size, but as a general guide the first protuberance is located at a cuspid tooth, the second protuberance is located at a first bicuspid tooth, and the third protuberances located at a second bicuspid tooth. Patients with small tongues or large hard palate surface area, may warrant repositioning of the protuberances to ensure that all three groupings, central and both lateral clusters, are molded so as to be positioned within the anterior one-third of the user's mouth when the mouthpiece is in place.
Each of the protuberances 20, 21 will have a height of 1 mm to 5 mm, which depends upon the tongue response and topography of the patient's mouth. Cases where the arch of the hard palate is higher than average, may necessitate protuberances having a height greater than 5 mm, and one of ordinary skill in the creation of oral appliances will be able to readily determine if such a palate abnormality exists. As mentioned above, protuberances may be tuned to a specific individual and may therefore vary in size and shape relative to each other or be of substantially the same size and shape. Tuning may include increasing or decreasing the diameter of a single protuberance as well as increasing or decreasing the general roundness of a single protuberance. It should be understood that all protuberances are smooth without distinct edges that can damage the sensitive tissues of the oral cavity. Jagged or rough areas can cause abrasion over time and will cause the tongue to avoid the protuberance containing the rough spots. This is counterproductive as it directs the tongue away from an area that might otherwise be used to guide the tongue forward.
A plurality of protuberances 22 grouped in lower lateral clusters are formed on the left and right mandibular extensions of the lingual surface. On each side a protuberance is located on the mandibular extension below the first molar, second molar, and second premolar. Natural occurrences of Tori Mandibularis are generally positioned near the pre-molars. The lower lateral protuberances of the present invention are positioned at these locations so as to create artificial dental Tori that will not abrade the tongue or disrupt its normal function. These nodular protuberances gently irritate lingual nerve branches in the lateral portions of the inferior tongue, which communicates the irritation to the brain and hypoglossal nerve. Motor function of the genioglossus muscle is then initiated, moving the tongue forward. Genioglossus insertion occurs along the inferior and lateral tongue, making stimulation of this area particularly effective for achieving forward repositioning. Some patients may find that independent use of the lower mouthpiece provides better results than independent use of the upper mouthpiece; however, this will vary according to anatomy of different users.
It will be understood by one of ordinary skill in the art that the lower lateral protuberance clusters may be shifted slightly toward the anterior of the mouth. While anterior shifting may be necessary to achieve proper genioglossus motor function for some patients, posterior shifting should be avoided. As is shown in
Patients may utilize either one, or both of the mouthpieces to alleviate sleep apnea, reduce bruxism, and improve muscle tone. As discussed above, the Tori-like protuberances of the present invention gently irritate the anterior dorsum and/or lateral inferior tongue, making the wearer want to move the tongue forward within the oral cavity. This is an exercise in targeted micro muscle manipulation. While the patient is wearing the mouthpiece, he is consciously or subconsciously flexing and contracting various muscles within the tongue, throat, and face. Movement and manipulation will tone and strengthen the associated musculature. Strengthening these muscles will improve overall breathing capabilities and may lead to reduced need for nighttime use of the mouthpiece, because the throat muscles may grow strong enough to remain dilated without intervention. These results will vary based on user anatomy and the underlying causes of the apnea. Secondly, those wearing the oral appliance to reduce damage associated with bruxism, will appreciate the soft, and shock absorbent construction that cushions their teeth from pressure. The forward protrusion of the tongue caused by the protuberances will open up the bite slightly, making it difficult for the wearer to clamp his teeth down and grind. In this way, the mouthpieces can alleviate both the symptoms of bruxism and help reduce the user's ability to grind the teeth. Bruxism associated with sleep apnea is treated by reducing occurrences of nighttime apnea episodes. For those wearers who use the device to improve physical performance, the effects of strengthened facial and throat muscles will be obvious as they experience increased air intake and eased swallowing. Thus, the present oral appliance provides a wide variety of benefits to wearers.
The appliance described herein is the preferred configuration, but the addition of strategically placed protuberances to other oral appliances may convey some of the benefits. Modification of other appliances is achieved through application of dental resin to the appliance to form mounded protuberances, as shown with differing shading in
First, the dentist, or other dental professional measures the topography of the patient's mouth at step 100. This can be done by creating a mold of the mouth and teeth, imaging the area, or by taking physical measurements. By determining where the anterior and posterior tongue rest within the oral cavity, and its positioning with respect to the patient's teeth, the dentist can figure out the proper placement of the protuberances. The oral appliance is marked, to indicate this positioning and may be applied to a model to ensure correctness of markings.
Next, an orthodontic resin such as dental acrylic is mixed at step 110. Most dental resins are transported in powder form for easy storage. Liquid monomer acrylic is added to the powder and stirred, to create a tacky, deformable resin. Using a metal spatula or other suitable applicator, the dental professional applies the dental resin to marked areas of the appliance at step 120. It may be applied in domes or mounded regions. Before the resin has time to set, a moistened cotton swab is used to shape the applied resin into protuberances at step 130. This will include the, smoothing of the sides, and may call for the addition or removal or resin. The resulting protuberances should have the generally desired shape and size but do not need to be perfectly dimensioned because refinement will occur at the end of the process.
The oral appliance, with newly applied dental resin is then placed in a pressure pot until the dental resin partially sets at step 140. After setting, the resin will still be malleable, and ready for finalization of the protuberances. The protuberances of the oral appliance are refined at step 150 through gentle application of pressure to the thick resin. Once again, a moistened cotton swab is useful for this step. First the dental professional creates valleys in the unfinished protuberance at step 151, thereby forming multiple nodules from one protuberance. These nodules are then manipulated and shaped into individual protuberances at step 152. Shapes of the variety disclosed above are contemplated, such as oblong, domed, conical, and ridged. Once the desired height and shape is obtained, the protuberances are smoothed to eliminate rough spots or jagged edges at step 153. The oral appliance is set in the pressure pot until fully formed and then cooled.
Referring now to
The oral upper appliance 211 includes an anterior end 212 which is oriented toward the front of the user's mouth and a posterior end 214 which is oriented toward the rear or back of the user's mouth, when worn. The oral appliance 211 comprises a dental trough 220 defined by a facial surface 222, a lingual surface 224, and a connecting occlusal surface 226. The trough 220 extends from posterior end 214 to anterior end 212 to posterior end 214, defining anterior and posterior portions of the facial 222 and lingual 224 surfaces. The trough 220 defines an area where the teeth are disposed when the oral appliance is worn. The trough 220 generally may be defined as one continuous U-shaped structure or area, or may be described as a having a first portion and a second portion joined at the central anterior area of the oral appliance 211.
A palate or palatial surface 230 extends from the lingual surface 224 of the oral appliance 211. The palate surface 230 is disposed against the hard palate of the user's mouth when the oral appliance 211 is in use.
At an anterior lingual wall 215 of the trough 220, a stippling 240 is located. The stippling 240 is an area of small specks that may be arranged in a pattern, may be of the same size, or may be of varying size. The stippling 240 may be a plurality of raised specks 242 or may be a plurality of indentations, or may be a combination. The specks 242 may be circular or may be of other shapes.
For non-limiting example, in the depicted embodiment, the specks 242 define a plurality of columns in a vertical direction. The specks 242 may also define a plurality of rows in other embodiments. The specks 242 are offset upwardly or downwardly from one another moving in a horizontal direction along the lingual surface 224.
In some embodiments, the oral appliance 200 may also comprise a plurality of protuberances 250. The protuberances 250 are depicted along the palatial portion 230 of the oral appliance 211. In some embodiments, the protuberances 250 may be disposed centrally on the palatial surface 230 of the oral appliance 211. Further, the protuberances 250 may extend centrally in the anterior-posterior direction. These central protuberances 252 may be of the same size or of differing sizes. Further, the protuberances 250 may be hemi-spherical in shape but other shapes may be utilized.
The lateral protuberances 254 may also extend laterally along the palatial surface 230 of the oral appliance 211. These lateral protuberances 254 may intersect the central protuberances 252. The lateral protuberances 254 may extend linearly, when viewed from below, or may extend at an angle to the central protuberances 252. Although the central protuberances 252 are shown in combination with the lateral protuberances 254, the central protuberances 252 may be used alone. Alternately, the lateral protuberances may be used alone. Or, the two groups of protuberances may be used together as shown.
With reference to
Also shown disposed about the oral appliance 211, and specifically within the trough 220, are a plurality of apertures 216 (
Referring now to
Extending from the lingual surface 324 on either side of the centerline of the oral appliance 311 are protuberances 350. The protuberances 350 are shown in two groups of nodules 351, one group of nodes on the left side and one group on the right side. The protuberances 350, and more specifically the nodules 351, are shown extending inwardly to engage the user's tongue. The nodules 351 may be various shapes and in some embodiments, may be for non-limiting example, spherical. Other shapes may be used however.
In some embodiments, the protuberances 350 may include one or more nodules 351. The instant embodiment, for example, includes three nodules 351 on each side but other numbers, shapes, and sizes may be utilized and this disclosure is not limiting.
At the anterior lingual surface 322 of the oral appliance 311 may also be a stippling 340. The stippling 340 also acts to stimulate tongue movement. The stippling 340 comprises a plurality of specks 342 which may or may not be formed in a pattern. The pattern may comprise a plurality of columns or rows for example. As shown, in some non-limiting embodiments, the specks 342 may define a plurality of columns, wherein the specks 342 are offset from one another along a horizontal direction. Alternatively, the specks 342 may be offset in an alternative direction.
As with the previous embodiment, the specks 342 may be raised relative to the surrounding surface or may be indented relative to the surrounding surface. Further, the specks 342 are shown are partially spherical, but other shapes may be utilized. Any shape may be utilized which stimulates the tip of the tongue and causes movement of the tongue to increase the opening size of the airway.
As with the previous embodiments, the protuberances 350 may be used alone. Alternatively, the stippling 340 may be used alone. As a further alternative, the stippling 340 and the protuberances 350 may also be used together, as shown in the Figure.
With reference now to
In this view, the occlusal surface 326 is shown on the upper side of the oral appliance 311 as the device is used with the lower teeth of a user. As will be described further herein, the oral appliance 311 may be a single or grade of material or multiple materials or grades of a material. The occlusal surface 326 may for example be formed of a differing grade of material than the remainder of the device. Or in some embodiments, the stippling 340, or the protuberances 350 may be formed of a differing grade of material.
In these embodiments, the oral appliances may be formed of one or more materials. In some embodiments for example, the oral appliance may be formed entirely of, or partially of, VISTAMAXX. The polymer blend of the moldable portion 120 may include one or more grades of Vistamaxx™ produced by ExxonMobil of Houston, Tex. 77253. Table 1 includes a listing of various grades of Vistamaxx™ that may be used in the moldable portion and various respective properties, including ethylene content, Vicat softening point (ASTM D 1525), flexural modulus, and hardness (ASTM D2240) Shore D/A. The grades of Vistamaxx™ provided in Table 1 are merely illustrative, non-exhaustive, and should not be considered limiting.
In some instances, it may be desirable to blend two or more grades of Vistamaxx™ at varying percentages in order to achieve a desired level of hardness and/or impact resistance of the composition of the moldable portion 120. While the Table 1 shows specific examples, one skilled in the art should realize that various other grades may be used alone or in combination with one another. The list of Table 1 is non-exhaustive.
The oral appliance for example may be made from a thermoplastic polyolefin elastomer may be formed in some non-limiting examples as set forth in Table 2. The oral appliance comprises physical and mechanical properties that match or surpass prior art EVA mouthpieces. The oral appliance may provide a greater rate of crystallization or fitting time, i.e., the time interval before the material stiffens at body temperature, which improves fitting of the oral appliance. Oral appliance takes 2 to 3 minutes for the mouthguard to harden providing the user ample time to properly fit the mouthguard. During this time interval, the material remains soft and extensible. In addition, the high shrinkage of oral appliance allows the mouthguard to shrink, giving a snug fit with excellent retention to the teeth and jaw within 5 minutes.
It may be desirable, in some instances, for any of the compositions of the moldable portions 120 described herein to additionally include one or more foaming agents. For example, the use of a foaming agent may result in the reduction in use of raw material (e.g. polymer blends), which may decrease cost and the resulting moldable portion's carbon footprint. In some instances, the use of a foaming material may reduce the amount of polymer required by as much as 50%. Foaming agents may be used in order to introduce foaming, resulting in a polymer foam with air bubbles or tunnels disposed therein. These polymer foams may be either closed-cell or open-cell. Generally, closed-cell foams exhibit more rigidity, while open-cell foams tend to be more flexible.
For example, such a foaming agent may be a decomposable chemical foaming agent, which at elevated temperatures decompose to form gases or vapors allowing the polymer foam to form. Both organic and inorganic foaming agents may be used with the polymer blend. For example, organic foaming agents may include, but are not limited to: 4,4′-oxybis benzene sulfonyl hydrazide; azodicarbonamide; azobisformamide; azobisisobutyronitrile; diazoaminobenzene; N,N-dimethyl-N,N-dinitroso terephthalamide; N,N-dinitrosopentamethylene-tetramine; benzenesulfonyl-hydrazide; benzene-1,3-disulfonyl hydrazide; diphenylsulfon-3-3, disulfonyl hydrazide; p-toluene sulfonyl semicarbizide; barium azodicarboxylate; butylamine nitrile; nitroureas; trihydrazino triazine; phenyl-methyl-uranthan; p-sulfonhydrazide; and/or peroxides. Inorganic foaming agents may include, but are not limited to: ammonium bicarbonate and/or sodium bicarbonate. In other instances, Ecocell® produced by Polyfil, Rockaway, N.J. 07866, may be used as a foaming agent in the composition of the moldable portion.
In some embodiments, additional polymers (e.g. elastomers, plastomers, rubber, etc.) may be mixed with the propylene-ethylene copolymer (including one or more of the various grades of Vistamaxx™) in order to change and/or enhance various properties of the co-polymer. For example, the addition of an elastomer, which is a polymer with viscoelasticity, may increase the ease with which the moldable part is molded to the user.
In some embodiments, it may be desirable for the oral appliance to be constructed of two separate components, where each component may be a moldable portion described herein. In such instances, it may be desirable to have harder shell component and a softer core component for the oral appliance. Such a construction may be particularly advantageous in appliances where a hard outer component is typically used to absorb the bulk of an impact and a softer portion to further protect the area of the mouth.
In some instances, the moldable portion (or in some embodiments, the entire guard) may be heated until moldable, meaning the moldable portion is pliable for shaping by the user without any additional equipment, through the use of a microwave oven. It is known that microwaves do not typically interact with most polymer compositions, it is for this reason water has typically been used during microwave heating of polymers or polymer blends. For example, in some instances a polymer or polymer blend may be placed in a water bath in the microwave oven or wrapped in a wet cloth prior to placing in the microwave oven.
However, in some instances it may be desirable, for example for ease of use by the user for a dry heat (e.g. without the use of water in the heating process) to be used. In such instances, the moldable portion may additionally include a microwave susceptor that allows the moldable portion to absorb the microwaves. Generally, a susceptor may be a material used for its ability to absorb electromagnetic energy and convert it to heat. In addition to the polymer or polymer blend, the composition of the moldable portion may in some instances, include between 1% and 15% microwave susceptor. Where the moldable portion has a larger amount of a microwave susceptor the reaction to the microwave activity may increase, and therefore heating intensified. Where the moldable portion has a smaller amount of a microwave susceptor the reaction to the microwave activity may be decrease, and therefore the heating may be less intense. More specifically, in some instances the composition of the moldable portion may be about 5% microwave susceptor. In some instances, the microwave susceptor may be a carbon structure, such as carbon black, carbon fibers, carbon nanotubes, graphene. In other instances, the microwave susceptor may include various conductive or magnetic materials (e.g. metals, metal salts, metal oxides, zeolites, hydrated minerals, hydrated salts of metal compounds, polymeric receptive materials, clays, silicates, ceramics, sulfides, titanates, carbides, sulfur, inorganic solid acids or salts, polymer acids or salts, inorganic or polymeric ion exchangers, clays modified with microwave-receptive compounds, etc.).
Moldable portions of the various compositions described herein may possess certain characteristics that are desirable in an oral appliance. For example, as described previously herein, the moldable portion may be capable of being heated in a microwave oven and formed and reformed a second, third, and so on times, allowing for adjustment of the appliance. For example, this reforming may be desirable to correct an initial poor fit, or to allow for change in fit as a wearer grows (particularly relevant where the user is a child or adolescent), or any other situation for reformation may be desirable. As another example, the moldable portion may be impact resistant or shock absorbing. This may be particularly desirable where the oral appliance is used in a contact sport (e.g. football, lacrosse, etc.), where impacts are common and desired to be protected against.
Wearers of the modified oral appliance will experience forward tongue protrusion and thus increased air intake. The extent of dilation will be affected by the configuration of the oral appliance. In this way, a patient having a medically necessary oral appliance will be able to experience increased air flow without having to switch the necessary oral appliance out for the mouthpieces of the present embodiments.
In use, in individual places the upper mouthpiece in the oral cavity with the protuberances extending downward. He aligns the dental trough with his teeth then gently pushes upward on different sections of his teeth until the mouthpiece snuggly abuts the teeth surfaces. Next, the lower mouthpiece is placed in the oral cavity with the protuberances extending upward. The two dental troughs are aligned with the user's pre-molars and first molar and then gently pressed downward. An anterior facial bridge will fit snuggly against the facial gum line of the lower teeth, connecting the two dental troughs. The upper and lower teeth may be gently pressed together to mash the mouthpieces in place. Once the two pieces of the oral appliance are in place the user can participate in activities as normal. Sports, meetings, sleeping, or any other activity can be enjoyed without impaired speech or fear of bruxism damage. It conveys a number of health benefits and reduces instances of sleep apnea.
The present embodiments is a two-part oral appliance and method of retrofitting protuberances to an oral appliance. The upper and lower mouthpieces may be worn individually or in conjunction. In many patients, benefits will be experienced with the use of either mouthpiece individually. The lower mouthpiece in particular is well suited for individual use because it does not cover the anterior teeth and therefore is not visually unappealing. Both mouthpieces are constructed of a soft, flexible, shock absorbent material. They are clear or highly translucent and have a thickness of a few millimeters, making them visually unobtrusive when worn.
It is therefore submitted that the instant embodiments are shown and described in what is considered to be the most practical and preferred embodiments. It is recognized, however, that departures may be made within the scope of the embodiments and that obvious modifications will occur to a person skilled in the art. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the embodiments, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present embodiments.
Therefore, the foregoing is considered as illustrative only of the principles of the embodiments. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the embodiments to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the claims.
This Continuation-In-Part patent application claims priority to and benefit of, under 35 U.S.C. § 120, U.S. patent application Ser. No. 15/935,198 filed on Mar. 26, 2018, which claims priority to and benefit of U.S. patent application Ser. No. 13/776,109, now issued as U.S. Pat. No. 9,968,419, filed on Feb. 25, 2013, which claims priority to and benefit of U.S. patent application Ser. No. 13/007,620, filed on Jan. 15, 2011, which claims priority to U.S. Provisional Application No. 61/357,795 filed on Jun. 23, 2010. For the purposes of providing a clear and continuous disclosure, the above identified patent applications are herein incorporated by reference in their entirety to provide continuity of disclosure.
| Number | Date | Country | |
|---|---|---|---|
| 61357795 | Jun 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15935198 | Mar 2018 | US |
| Child | 17484592 | US | |
| Parent | 13776109 | Feb 2013 | US |
| Child | 15935198 | US | |
| Parent | 13007620 | Jan 2011 | US |
| Child | 13776109 | US |
