Methods and apparatus for improved interocclusal mandibular...

Dentistry – Orthodontics – By mouthpiece-type retainer

Reexamination Certificate

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C433S019000

Reexamination Certificate

active

06769910

ABSTRACT:

BACKGROUND OF THE INVENTION
The present disclosure relates to improved methods and apparatus for use in mandibular repositioning. More particularly, the present inventions relate to creating a custom fitted mandibular repositioning appliance that is easily adjustable and customized while reducing tissue impingement that may otherwise compromise airway space and/or architecture. The inventions' consist of manners of attachment situated between the mandible and maxillary bite block or occlusal plains permitting structural stability and integrity allowing for user comfort and mobility as never before addressed or available. Furthermore, the attachment means element allows for infinite horizontal and vertical adjustability within the dimensions of the appliance and its attachment means. The novelty of this invention stems from the attachment means used and the location thereof.
The inventions relate to therapy in the treatment of sleep apnea, snoring, bruxism, and other now known or future diagnosed oral, respiratory, dental and developmental disorders that may affects the dentition and surrounding skeletal and muscular structures. In particular, the present inventions relate to improved methods and apparatus for enhanced precision and control of interocclusal devices used in patient therapy.
Difficulty in breathing while sleeping often manifests itself as snoring or the more serious obstructive sleep apnea. Snoring is a condition affecting approximately forty percent (40%) of the adult population, while sleep apnea is believed to affect at least twenty (20) million people.
In turn, bruxism consists of a static and/or dynamic contact between the dentition of the mandible and maxilla. Bruxism is commonly referred to as “tooth grinding” which results in the physical destruction of tooth enamel directly leading to tooth decay as well as more serious problems. Bruxism affects nearly fifteen percent (15%) of the population and in advanced stages bruxism results in the abnormal and excessive grinding or clenching of teeth while an individual is asleep. Bruxism is medically classified as parasomnia or sleep disorder. In some instances a person may be so unaware of the problem that it may occur while awake. As the individual may not be conscious of the problem, if bruxism becomes a habit it may become even more difficult to treat.
The actual cause of bruxism is not clear, however reference has been made to causes being related to emotional stress or other psychological factors. Common treatments range from psychotherapy, sedatives or tranquilizers and may further include bio-feedback, i.e. electrodes being taped to the jaw.
In turn, temporomandibular joint syndrome (or dysfunction) (“TMJ”) is a disorder effecting the joint between the lower jaw and the skull. The temporomandibular joint lies between the temporal bone of the skull and the mandible of the jaw, and allows the jaw to open and close. The joint is formed by a condyle on the mandible which hinges and glides in and out of the depression in the temporal bone.
TMJ can be caused by bruxism, malocclusion, trauma, and arthritis. There is also an indication that a posterior or backward displacement of the condyle of the jaw significantly contributes to TMJ pain. TMJ has been associated with a wide variety of physical aliments, including migraine headaches. TMJ related headaches can become so severe as to cause nausea and blurred vision. Most people afflicted with TMJ suffer from a myo-facial pain-dysfunction syndrome primarily as a muscle problem related to dental/skeletal relationships and tensional factors. The effects can range from mild to severe, including pain in the joint area that can extend to the shoulders, back, neck, and sinuses. As a treatment, surgery is only utilized in the most severe cases, which represent approximately ten percent (10%) of those seeking treatment.
Accordingly, the medical profession and related health care industries have now begun to recognize the paramount importance of developing new and innovative techniques that effectively address one (1) or all of the aforementioned maladies. Therein, oral appliances (interocclusal devices) have been employed to prevent the tongue and/or collapse of oral pharyngeal tissue from obstructing the airway. To date, when used in the treatment of snoring or sleep apnea, these prior techniques and devices have been either unsuccessful, met with limited success or have resulted in undesirable side effect(s).
In a paper entitled
Dental Appliances for the Treatment of Snoring and/or Obstructive Sleep Apnea,
by Alan A. Lowe published in
Principles and Practice of Sleep Medicine,
W. B. Saunders Company, Second Edition 1994, chapter 69, pp. 772-785, a number of commercially available or experimental devices known were described together with their inherent problems and advantages. Most of these devices manipulate the tongue or adjust the relative positions of the mandible to the upper jaw. The latter being more desirable because the less the tissue contact, the less the tissue irritation and damage.
Tongue devices such as U.S. Pat. No. 4,715,368, and Reissue No: 33,442, issued to George discloses an oral device preventing the closure of the breathing passage. The George device uses flanges to depress and constrain the tongue.
U.S. Pat. No. 3,132,647, to Corniello teaches keeping the air passage open by engaging and depressing the rear portion of the tongue while supporting a portion of the downwardly hanging soft palate. The Corniello device resembles the :upper portion of an athletic mouth guard, with a metal tongue depressor at the back.
U.S. Pat. No. 4,169,473, to Samelson describes a device for positioning within the mouth of a user to prevent snoring and nocturnal bruxism. The Samelson device has an integrally molded body providing dental engaging arches and a rearwardly-opening central socket for cooperating with the forward portion of the user's tongue in a manner which draws the tongue forward in order to increase the oral-pharyngeal airway space.
U.S. Pat. No. 3,434,470, to Strickland functions to control the amount of air capable of passing through the mouth, either lessening the intake volume of air to an extent wherein the person is incapable of producing a snore, or shutting off completely the passage of air through the mouth. The limitations with these types of devices are in restriction of airflow, impedance and limited or hindered tongue mobility, and thus tend to interfere with normal swallowing patterns. Importantly, constraint(s) placed upon the tongue tends to be uncomfortable and thus discourage use, resulting in decreased patient use and limited effectiveness.
Conversely, the Herbst appliance is an oral device that attempted to realign the mandible and maxilla. The Herbst appliance, which is shown in German Patent No. 374,163, consists of a metal band placed around an upper molar and lower incisor tooth. The two (2) bands are interconnected by a telescopic member and exert an anteriorly directed force on the mandible. This device needs great strength to resist “breakage” from lateral jaw forces. Whereas, another Herbst appliance uses retentive blocks rather than banding directly to teeth.
Other, similar telescopic devices include those shown in U.S. Pat. No. 3,618,214, to Armstrong, as well as many other similar patents. All of these devices teach required wires or braces for attachment to the patient's teeth.
U.S. Pat. No. 4,901,737, issued to Toone exemplifies the prior devices. Toone discloses an intra-oral appliance for reducing snoring which repositions the mandible in an open and protrusive position as compared to the normally closed position of the jaw. The Toone appliance includes a pair of V-shaped spacer members formed from dental acrylic which extend between the maxilla an mandible to form a unitary mouthpiece.
U.S. Pat. No. 1,674,336, to King teaches an appliance for placement between the teeth of the user. The King device resembles an athletic mouth guard, and has upper and lower channels which receive the upper and lower

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