Surgery – Body protecting or restraining devices for patients or infants – Head or face protector
Reexamination Certificate
1998-09-28
2001-11-13
Brown, Michael A. (Department: 3733)
Surgery
Body protecting or restraining devices for patients or infants
Head or face protector
C128S861000
Reexamination Certificate
active
06314960
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to methods and devices for administration of medicaments to oral tissues. More specifically, this invention relates to devices and methods of treatment of diseases of the teeth and gums.
BACKGROUND OF THE INVENTION
Fossil evidence indicates that periodontal disease and dental caries have plagued mankind throughout the history of human existence. Both dental caries and periodontal disease are caused by the bacterial invasion and colonization of the dental plaque, which invasion is constantly in progress on all tooth surfaces exposed within the oral cavity.
Sampling and identification of the plaque bacteria indicate that a wide variety of bacteria coexist as infective agents within the dental plaque. To date, it has not been possible to identify any one organism as the singular pathogenic agent in either dental caries or periodontal disease. It is probable that several infective organisms interact synergistically to cause such diseases.
Throughout history, the mechanical removal of bacteria-laden dental plaque from the teeth on a daily basis has been the first line of defense against dental caries and periodontal disease. However, mechanical methods to remove plaque, such as by brushing, are not effective in removing such plaque from a significant portion of dentition surface area. Moreover, because plaque bacteria reproduce rapidly, recolonization of such mechanically cleaned areas occurs within twenty-four hours.
The extent to which oral disease agents can be kept in check is dependent on several factors which are, in order of importance, (i) daily mechanical removal, (ii) the individual's immune competence, (iii) regularity of dental check-ups and cleaning, and (iv) use of intraoral chemical plaque control agents such as rinses and toothpastes. The current invention is primarily designed to affect factors (i) and (iv).
Currently several methodologies are utilized to control dental caries and periodontal disease. Some methodologies comprise rinses which are only partially effective in killing plaque bacteria. Importantly, no rinse method will reach the subgingival plaque which is of greatest threat to dental health.
Other methodologies utilize systemic antibiotics. Delivery of antibiotics via the bloodstream is reasonably effective in controlling gingival infections where the plaque bacteria have invaded the tissues adjacent to the plaque. However, systemic antibiotics have very limited capability to kill plaque bacteria which reside within the plaque itself, since the dental plaque has no blood supply.
In another example, polymeric compositions are disclosed which are designed to release medicament after implantation (U.S. Pat. No. 5,607,686). Such compositions must be carefully placed so as not to incite the formation of tissue adhesions. In yet another example, U.S. Pat. No. 4,681,544 discloses a device designed to retain an oral pack. Such device is semi-permanently mounted to the tooth and its only function is to retain the pack in place. The examples of these patents provide only localized administration of treatments. Various mouth devices for inhibiting snoring and sleep apnea, such as U.S. Pat. Nos. 5,056,534, 5,365,945, 5,003,994, 5,042,506, 3,434,470, 4,304,227, 4,676,240, 5,092,346, 5,117,816, 5,277,202 and others. None of these have been applied against periodontal disease.
Thus, regardless of typical methods utilized to treat and prevent dental disease, it has been all but impossible to effectuate fully the elimination of anything close to 100% of such disease causing agents. In contrast to devices and methodologies which rely on rinses or systemic administration, the current invention provides a novel technique and device which will cause the administration of medicaments into the dental plaque by mechanical action comprising chewing motions of the jaw combined with an apparatus designed to act as an alternating high pressure/low pressure pump.
SUMMARY OF THE INVENTION
The object of this invention is to deliver medication to the teeth and gums of a human. More particularly, it is the object of this invention to deliver medication to the root surfaces of the teeth and gingival tissues within the gingival crevices below the gum line, where it has traditionally been difficult to deliver medication effectively. It is a further object of the invention to deliver medication to the farthest reaches of any periodontal pockets existing under the gums.
One embodiment of the invention provides for a resilient buccal shield across the front of the device which acts to seal the mouth cavity from air flow around the lips.
Another embodiment of the invention provides for resilient upper and/or lower dental arch receiving trays wherein the trays are made so as to encompass all the teeth of the upper and/or lower arches. A further embodiment of the invention provides medication reservoirs or pockets within the trays that further provide action as a rubber-bulb type suction pump.
It is another object of the invention to deliver medicament to oral tissues by succession of positive and negative pressures created from the alternating formation of a partial vacuum and release thereof in and around the gingival tissues. It is a further embodiment for the partial vacuum to be created by action of up and down jaw movement in relation to dental arch receiving trays of the invention.
REFERENCES:
patent: 3527219 (1970-09-01), Greenberg
patent: 3536069 (1970-10-01), Gores
patent: 4138814 (1979-02-01), Weitzman
patent: 5682904 (1997-11-01), Stinnett
Brown Michael A.
Long Thad G.
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