Surgery – Body protecting or restraining devices for patients or infants – Antisnoring device
Reexamination Certificate
1999-10-01
2002-06-25
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Antisnoring device
C128S859000, C602S902000
Reexamination Certificate
active
06408851
ABSTRACT:
FIELD OF INVENTION
This invention relates to a device that decreases interference of breathing during sleep. More particularly, this invention relates to a device that the user can insert into their mouth that alleviates snoring and obstructive sleep apnea.
BACKGROUND OF THE INVENTION
Snoring sounds are vibrations as air passes collapsed structures caused by the relaxation of body tissues during sleep. The tissues which collapses are especially in the lingual compartment, including the tongue, the pharyngeal folds, the soft palate, the muscles of the uvula, and the palate-pharyngeal arch, the pharynx, and the larynx. Muscle tone during normal waking hours maintains the airway patent for free passage of air. Obstructive sleep apnea (OSA) and obstructive breathing (snoring) are mainly caused by the collapse of the airway, especially when the soft palate relaxes while the tongue falls to the back of the throat, both blocking the airway. In OSA, the airway becomes intermittently blocked by the tongue and other airway structures, and at times the person or animal cannot breathe at all.
Uvulopalatopharnygoplasty, adenoidectomy, tonsillectomy, orthognathic, genioglossus advancement, hyoid suspension, lingual plasty, lingual reduction, and other surgery of the mouth, pharynx, hypopharynx and tongue are used for correcting sleep disorders such as OSA or snoring. A need exists for a simple and convenient method and apparatus to obviate surgery while providing a means to bring the tongue forward.
DESCRIPTION OF PRIOR ART
Various devices for preventing or decreasing snoring are known in the prior art. For example, Samelson, in U.S. Pat. No. 4,304,277, discloses a device providing a rearwardly open central socket that cooperates with the forward portion of a user's tongue in such a manner as to draw the tongue forward to increase the unobstructed dimension of the breathing passage. The tongue is held in the socket by negative pressure developed in the socket. The tongue thus held draws the body of the tongue forward thereby increasing the dimension of the air flow passage to facilitate breathing.
Karell in U.S. Pat. No. 5,792,067 discloses a means to reduce or prevent snoring and OSA by increasing muscle tone to airway structures (muscles) by applying electrical energy through strategically placed electrodes within a removable dental appliance. Karell discloses an intraoral structural support containing electrodes for making contact with intraoral mucosa. Energizing the electrodes with electrical energy causes stimulation to nerves and muscles, which in turn causes increased muscle tone and muscle contraction.
The present invention provides a method and device that can prevent snoring and OSA. The device can be adjusted and form fitted by the user, is of simple design, and may be more comfortable than the devices disclosed by the prior art.
One object of the present invention and method is to provide an anti-snore or anti-OSA device that serves to hold the tongue in a forward position, thereby drawing the remainder of the tongue forwardly to increase airway passage.
A further object of the present invention is to provide an anti-snore or anti-OSA device that provides an airway within the appliance. Also, the airway has the capability for attaching to other medical equipment such an an ambu bag or other airway means, including oxygen delivery, respiratory and CPAP systems.
A further object of the present invention is to provide an anti-snore or anti-OSA device that provides one or more electrodes for making contact to intraoral structures for increasing muscle tone by the application of energy from an energy source.
Another object of the present invention is to provide an anti-snoring or anti-OSA device which is moldable after immersion in boiling water or some other method of molding, so that it can be adapted by the user to have a comfortable and individualized fit.
And still another object of this invention and method is to provide an anti-snore device which also prevents bruxism (nocturnal tooth grinding), by bringing the tongue forward through the teeth.
And still another object is provide for a configuration allowing for unity of construction thereby having no parts which may be swallowed.
And still another object is to provide for a configuration allowing for emergency airway usage.
And still another object is to provide a simple method for keeping a tongue forward during sleep and at other times.
These and other objects and advantages of the invention will become clear from the following description of a preferred embodiment of the invention.
SUMMARY OF THE INVENTION
A device of the instant invention can be readily adapted to fit any particular user's mouth, human or animal, for the prevention of bruxism, snoring, other obstructed breathing problems such as OSA, and may be fitted and adjusted by the user. In general, the method for reducing interference of breathing during sleep comprises the following steps: (a)making a hole in a user's tongue; (b)molding an structural support to a user's mouth; (c)wherein the structural support comprises a releasable fastener; (d)placing the releasable fastener through the tongue hole thereby affixing tongue to structural support, pulling tongue forward and preventing obstruction to the flow of air. The device of the instant invention utilizing this method comprises a structural support for fitting within a user's mouth. Additionally, it comprises releasable fastener for holding the tongue in a forward position. A hole tongue may be made using various implements known in the art. The structural support may be a moldable material that contains the impressions of all or part of the upper and/or lower teeth or gums of a user. The releasable fastener may be a firm or non-firm structure passing through the tongue, as do body piercing tongue rings/posts/bars and strings. Prior to going to sleep, the user inserts the device into his or her mouth, passes the releasable fastener through the tongue, and affixes the tongue to the appliance. In this manner, the forward portion of the tongue is held firmly in position to, as example, the rear of the incisor teeth region, thereby pulling the entire tongue forward, thereby opening the airway. The releasable fastener may simply be a hook. Or it may be a pivoting bar which after passing through the tongue, pivots to become a substantially perpendicular “T” shape for comfortably resting under the tongue (that is, the sublingual region of the tongue). The releasable fastener may additionally have a piercer for piercing through a tongue when no previous hole was made.
Although the preferred configuration would be a one-piece device, fastener may be separate from the structural support. An example of such a configuration is one in which a hook-and-eye arrangement is utilized, wherein, for example, the structural support has the hook and the fastening means has the eye. There are many coupling systems are known to the art; for example, the structural support may contain a magnet and another magnet may be inserted through the tongue, or a screw threaded coupling may be utilized.
A simpler method for reducing interference of breathing during sleep may be to place a bar through a forward portion of a tongue so that during sleep the bar can be positioned external to a user's teeth for keeping the tongue in a forward position.
The device may additionally have an airway and/or electrodes. U.S. Pat. No. 5,792,067 to Karell is disclosed and is incorporated herein by reference. This patent teaches a device and method and provides appropriate techniques and devices amenable to the practice of the instant invention.
The device may be configured for use in emergency situations in which case the structural support is configured as an airway with a stop. In this configuration the releasable fastener contains a sharp piercer for piercing through a tongue which has no previous hole. Also, the airway has the ability for attaching to an ambu bag and other airway devices, including oxygen delivery, respirat
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