Method of fabricating a flexible retentive bite block

Dentistry – Orthodontics – By mouthpiece-type retainer

Reexamination Certificate

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Reexamination Certificate

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06767207

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method of fabricating. More particularly, the present invention relates to a method of fabricating a flexible retentive bite block.
2. Description of the Prior Art
Snoring and Obstructive sleep apnea are typically caused by complete or partial obstruction of an individuals pharyngeal airway during sleep. Usually, airway obstruction results from the apposition of the rear portion of the tongue or soft palate with the posterior pharyngeal wall.
Obstructive sleep apnea is a potentially lethal disorder in which breathing stops during sleep for 10 seconds or more, sometimes up to 300 times per night. Snoring occurs when the pharyngeal airway is partially obstructed, resulting in vibration of the oral tissues during respiration. These sleep disorders tend to become more severe as patients grow older, likely as a result of a progressive loss of muscle tone in the patient's throat and oral tissues.
Habitual snoring and sleep apnea have been associated with other potentially serious medical conditions, such as hypertension, ischemic heart disease and strokes. Accordingly, early diagnosis and treatment is recommended.
One surgical approach, known as uvulopalatopharyngoplasty, involves removal of a portion of the soft palate to prevent closure of the pharyngeal airway during sleep. This operation, however, is not always effective and may result in undesirable complications, such as nasal regurgitation.
A wide variety of non-surgical approaches for treating sleep disorders have been proposed including the use of oral cavity appliances. It has been previously recognized that movement of the mandible (lower jaw) forward relative to the maxilla (upper jaw) can eliminate or reduce sleep apnea and snoring symptoms by causing the pharyngeal air passage to remain open.
Several intra-oral dental appliances have been developed which the user wears at night to fix the mandible in an anterior, protruded (i.e. forward) position. Such dental appliances essentially consist of acrylic or elastomeric bite blocks, similar to orthodontic retainers or athletic mouth guards, which are custom-fitted to the user's upper and lower teeth and which may be adjusted to vary the degree of anterior protrusion.
While prior art dental appliances have proven effective in maintaining the mandible in a protruded position to improve airway patency, they often result in undesirable side effects. One of the most common side effects is aggravation of the temporomandibular joint and related jaw muscles and ligaments, especially in individuals who have a tendency to grind their teeth during sleep.
Aggravation of the temporomandibular joint has been associated with a wide variety of physical aliments, including migraine headaches. Accordingly, many individuals suffering from sleep apnea and snoring disorders are not able to tolerate existing anti-snoring dental appliances for long periods of time.
The need has therefore arisen for a dental appliance for treatment of snoring and sleep apnea which will maintain the mandible in a preferred anterior position, allow a limited degree of lateral excursion of the mandible relative to the upper jaw to avoid discomfort to the temporomandibular joint and related muscles and ligaments, and be replaceably maintained on the user's teeth by virtue of its own flexibility and thereby eliminating the need for dental wires that can aggravate the teeth and gums and which require the appliance to have thick walls for their support which can lead to further discomfort for the user, such as gum and cheek irritation and gagging.
Numerous innovations for mouthpieces have been provided in the prior art that will be described. Even though these innovations may be suitable for the specific individual purposes to which they address, however, they differ from the present invention.
FOR EXAMPLE, U.S. Pat. No. 5,203,324 to Kinkade teaches a mouthpiece for use in diving or medical equipment, among others made of moldable resilient material having an offset between upper and lower jaw, a bite plane which is tapered with the bite plane formed by wings which have varying thickness to create the taper in which the wing members have substantially vertical surfaces on either side thereof for contacting the lateral surfaces of the user's cuspids and bicuspids and in which the main body portion has upper and lower apron and eminence skirts for avoiding contact with the user's frenum and cuspid eminence and in which the internal wing members have a range in size, at the cuspid, from about 6 to about 12 mm in width, from about 14 to about 40 mm in length and from about 2 mm to about 8 mm in thickness. The greater the offset, the shorter the length of the internal wind members.
ANOTHER EXAMPLE, U.S. Pat. No. 5,365,945 to Halstrom teaches a dentally retained intra-oral appliance worn at night for treatment of snoring and obstructive sleep apnea. The appliance maintains the patient's mandible in an anterior, protruded position to prevent obstruction of the pharyngeal airway. The appliance allows a limited degree of lateral movement of the mandible relative to the upper jaw in the protruded position to prevent aggravation of the patient's temporomandibular joint and associated muscle and ligaments.
STILL ANOTHER EXAMPLE, U.S. Pat. No. 5,409,017 to Lowe teaches a mandible repositioning appliance formed by an upper bite block and a lower bite block interconnected by an adjustable mechanism including a posterior section connected to the rear portion of the upper bite block and an anterior section connected to the front portion of the lower bite block and an adjustable interconnection between the anterior and posterior sections. Preferably, the adjustable interconnection includes a double thread element rotation of which changes the relative positions of the posterior and interior sections axially of the appliance and abutments to define each incremental rotation of the element. The comfort of the wearer is further improved by using a heat sensitive material in the tooth retention sections and by permitting limited relative lateral movement between the bite blocks.
YET ANOTHER EXAMPLE, U.S. Pat. No. 5,499,633 to Fenton teaches an adjustable oral device for placement within the mouth of a user to reduce or eliminate snoring. The device comprises an upper member having a substantially curved shape and defining an upwardly oriented channel for receiving at least some of the upper teeth of a user. A lower member has a substantially curved shape and defines a downwardly oriented channel for receiving at least some of the lower teeth of a user. The upper member is adjustably coupled by the user to the lower member in a spaced relationship such that the lower member is positioned relative to the upper member so that when the user's teeth are retained within the device, the user's lower jaw is biased substantially forward of its normal biting or resting position to reduce snoring. The device can include an anterior tongue space between the upper and lower members, and can further include moldable material positioned within at least one of the channels for substantially conforming to a shape of the teeth, thus allowing the device to be customized for individual users.
YET STILL ANOTHER EXAMPLE, U.S. Pat. No. 5,562,106 to Heeke et al. teaches a non-surgical oral appliance for improving breathing, and abating or completely alleviating snoring sounds and symptoms while sleeping. The patient is pre-tested and pre-fitted for the appliance so that the appliance positions the mandible in an open position and protrusive position to hold the mouth partially open. The appliance has a right and left extension wherein each extension has upper and lower surfaces pre-molded to the contour of the patient's back teeth. A bridge connects the right and left extensions having been pre-molded to conform to the upper palate of the patient's mouth. The upper and lower surfaces of each extension are spaced to provide

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