Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
2002-01-03
2003-10-28
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S020000, C604S503000, C600S590000
Reexamination Certificate
active
06638241
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to apparatus for treating bruxism.
BACKGROUND OF THE INVENTION
Bruxism has generally been defined as nonfunctional clenching, grinding, gritting, gnashing, and/or clicking of the teeth. Bruxism may occur while a person is awake or asleep. When the phenomenon occurs during sleep, it is called nocturnal bruxism. Even when it occurs during waking hours, the bruxer is often not conscious of the activity. Biting force exerted during bruxism often significantly exceeds peak biting force exerted during normal chewing. Chronic bruxism may result in musculoskeletal pain, headaches, and damage to the teeth and/or the temporomandibular joint. Bruxism has been connected with temporomandibular disorders (TMD) or temporomandibular joint (TMJ) syndrome.
One of the known treatments in the prior art for nocturnal bruxism is the use of intra-oral occlusal splints or “mouth guards,” which are generally semi-rigid plastic covers for the upper or lower teeth. Occlusal splints are generally fabricated for a specific individual from an impression taken of the individual's teeth. However, the occlusal splints often only protect the teeth themselves, while the user may still suffer musculoskeletal pain and possible damage to the temporomandibular joint. Moreover, occlusal splints present numerous inconveniences to the user. They may require frequent cleaning, may be difficult to clean, may require periodic replacement, may inhibit speech, and may be frequently lost.
Other techniques in the art attempt to combat bruxism through biofeedback. For example, an electromyograph has been used to sense the action of the masseter muscle. When muscle activity is detected, an audible tone is generated, which may alert the individual that he or she is bruxing. However, some biofeedback devices involve bulky electronics and may require electrodes to be attached adhesively to the face. Accordingly, such devices are considered impractical for long-term use in treating bruxism, and not well suited for consumer use.
Some variations on the biofeedback approach known in the art incorporate sensing means into an occlusal splint in order to sense the onset of bruxing. These approaches may require the presence of electrical devices in the mouth, including, in many cases, batteries, which may contain highly toxic substances. The electrical and chemical health risks of these devices add to the general drawbacks of intra-oral splints described above.
Another biofeedback device, called GRINDALERT is commercially available from Brux-Care, Inc., 84 Ship Street, Providence, R.I., USA (www.bruxcare.com). Instead of sensors in the mouth or bonded to the skin, GRINDALERT has a miniaturized sensing device incorporated into a headband. Bruxing may be sensed by the electrical activity of “obruxism muscles” (e.g., the temporalis and/or masseter muscles used to close the jaw). An electronics module processes the electrical signal from the bruxism muscles. When a threshold of intensity and duration is exceeded, the device emits an audible signal to provide feedback to the user, indicating the onset of a bruxing event. Data (including time, duration, and intensity) may be stored internally in response to a bruxing event. The data may be read out through connection to a personal computer, or via voice synthesis or a display.
However, a disadvantage of the audible devices of the art is that users may not wake up upon hearing the sound, especially if the user is a deep sleeper. In addition, users may become accustomed to the audible tone and unconsciously (or even consciously) ignore it.
SUMMARY OF THE INVENTION
The present invention seeks to provide improved apparatus for treatment of bruxism. The invention may use a variety of biosensors, such as but not limited to, electrodes, muscular activity sensors or nerve electrical impulse sensors, mounted in contact with a user's head, temples, forehead or jaw. In a preferred method of the invention, the biosensor provides biofeedback to a relaxation stimulant to relax the obruxism muscles or nerves, e.g., the temporalis and/or masseter muscles, or the maxillary or mandibular nerves associated with closing the jaw, such as but not limited to, the inferior alveolar nerve. The invention may relax the muscles or nerves by a variety of manners, such as but not limited to, chemical agents (e.g., laughing gas) or electrical stimulants to the muscles or nerves.
In contrast to the prior art, the invention may relax the bruxing event without any need for the patient to react to external, audible stimuli. Since the relaxing stimulus of the invention may work directly on the muscle or nerve, the patient may not become accustomed to the relaxing stimulus, thereby providing a significant improvement in reliability of the device.
There is thus provided in accordance with a preferred embodiment of the present invention apparatus for the treatment of bruxism, including a biosensor adapted to sense a phenomenon associated with a bruxing event, and a relaxation stimulator in communication with the biosensor and adapted to provide a relaxation stimulus to relax at least one of an obruxism muscle and an obruxism nerve.
In accordance with a preferred embodiment of the present invention the relaxation stimulator includes a drug delivery module adapted to administer a relaxant to a patient.
Further in accordance with a preferred embodiment of the present invention the drug delivery module includes an injection module adapted to inject a relaxant to a patient.
Still further in accordance with a preferred embodiment of the present invention the drug delivery module is adapted to emit a relaxant to air in a vicinity of a patient.
Further in accordance with a preferred embodiment of the present invention the drug delivery module includes a transdermal module adapted to administer a relaxant transdermally into a patient.
In accordance with a preferred embodiment of the present invention the drug delivery module includes a relaxant, such as a drug adapted to reduce transmission of nerve impulses to an obruxism muscle tissue.
Further in accordance with a preferred embodiment of the present invention the relaxation stimulator includes an electrical stimulator, such as a transcutaneous electrical stimulator.
In accordance with a preferred embodiment of the present invention the biosensor includes at least one of an electrode, a muscular activity sensor and a nerve electrical impulse sensor.
REFERENCES:
patent: 4669477 (1987-06-01), Ober
patent: 4715367 (1987-12-01), Crossley
patent: 5213568 (1993-05-01), Lattin et al.
patent: 6149577 (2000-11-01), Bouldin et al.
patent: WO 200287681 (2002-11-01), None
Dekel Patent Ltd.
Klein David
Kontos Lina R
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