Disposable dental treatment tray for holding medicament gel

Dentistry – Apparatus – Having intra-oral dispensing means

Reexamination Certificate

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C433S215000

Reexamination Certificate

active

06247930

ABSTRACT:

FIELD OF THE INVENTION
This invention is directed to a dental treatment tray and a combination of the tray with a medicament gel filling to be applied to the teeth and gums of a patient. More particularly, the present invention is directed to an improved dental treatment tray suitable for holding a gel containing a medicament such as a fluoride compound to be applied to the teeth and gums of a patient.
BACKGROUND OF THE INVENTION
It is often necessary for a fluoride containing gel or a gel containing another medicament to be applied to the teeth and gums of dental patients. For this purpose, it has been known to form a tray for the application of such a gel. Typically, these trays are disposable and are molded from a closed-cell polyethylene foam. An example of a conventional disposable tray is that sold by Oral-B Laboratories consisting of a unitary tray structure having upper and lower cups as depicted in US. Pat. Nos. Des. 273,893 and 5,211,559, incorporated herein by reference. Each of the cups has a shape which roughly conforms to the upper or lower teeth, i.e., a generally C-shape, and has a concave medicament receiving surface. The cups are secured together by hinge straps which normally maintain the cups in a planar relationship with both medicament receiving surfaces facing in the same direction. A gel is then loaded into the medicament receiving surfaces from a container such as a tube, after which the tray is folded about the hinge straps so that the cups overlie one another with the medicament receiving surfaces facing away from one another. The tray, in this folded state, is then inserted into the patient's mouth. The patient then bites down firmly into the concave medicament receiving surfaces and holds that position until the treatment is completed, after which the unit is removed from the patient's mouth and discarded.
It is important that disposable trays are fabricated from a soft, compliant material to provide a comfortable fit to the user. Early disposable trays were fabricated from a hard vinyl material which met with great complaints. It is also important that these disposable trays also maintain mechanical and chemical integrity during use. For example, disposable foam trays as described above have a tendency to warp and deform during use. This warping can cause the treatment gel to spill or leak from the tray. Furthermore, the hinge element of the tray can sometimes structurally fail, resulting in a very uncomfortable fit for the user. Still further, it is difficult to provide printed ornamentation and labeling on such tray, due to the fact that a wide number of medicament gels must are used in such trays; these medicament pose chemical compatibility concerns. Heretofor, these shortcomings have not been solved Therefore, it is an object of the present invention to provide a disposable dental treatment tray for holding medicament gels which solves these problems.
U.S. Pat. Nos. 4,173,219, 4,376,628, 4,428,373, 5,211,559, and Des. 273,893 discloses a disposable dental tray configurations which can be adapted to the present invention, all incorporated in their entirety by reference.
Treatment gels and foamable solutions containing fluorides and other medicaments, formulated and packaged for filling and application to the teeth and gums of a patient in a dental treatment tray by a dentist are well known. Particularly suited for use in the present invention are the fluoride foam medicated gels described in U.S. Pat. Nos. 4,770,634, 5,071,637 and 5,073,363, incorporated herein by reference.
SUMMARY OF THE INVENTION
The present invention relates to a tray for holding medicament to be applied to the teeth and gums of a patient, said tray being unitarily formed of a flexible composite material comprising a flexible, hydrophobic, fine-celled polymeric foam upper layer, a tying layer and a film bottom layer.
It is an object of the present invention to provide a tray for holding a medicament to be applied to the teeth and gums of a patient, which tray provides the user with a comfortable fit and exhibits improved mechanical and chemical resistance characteristics. Said trays are stable, even when decorated with ornamental printing.


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