Chemistry: analytical and immunological testing – Cancer
Reexamination Certificate
1994-09-13
2002-07-09
Wallenhorst, Maureen M. (Department: 1743)
Chemistry: analytical and immunological testing
Cancer
C422S067000, C424S009700
Reexamination Certificate
active
06417003
ABSTRACT:
This invention relates to improved methods of screening patients for epithelial cancer.
In another respect, the invention relates to a kit for use in screening patients to detect possible epithelial cancer.
More particularly, the invention pertains to a kit for use in screening patients for epithelial cancer, which can be used by medical personnel without highly specialized training.
In yet another respect, the invention pertains to a kit for use in screening patients for epithelial cancer, which places all of the necessary materials in “ready-to-use” form at the immediate disposal of clinical personnel, without requiring time-consuming or complicated mixing-storage-dispensing-measuring steps.
Various procedures are known for screening patients for epithelial cancer, especially for detecting suspected cancerous and precancerous sites on the mucosa such as the oral mucosa. Such procedures generally employ a dye which preferentially stains RNA-rich tissues, which have been recognized as characteristic of cancerous and precancerous conditions. For example, the U.S. Pat. No. 4,321,251 to Mashberg discloses such a procedure. The procedure of Mashberg involves sequential washes, rinses and applications of water, diluted acetic acid and a solution of toluidine blue-O dye in the mouth to detect cancerous and precancerous conditions of the oral mucosa. This wash-rinse-application-rinse-wash procedure is then repeated when a suspected site is detected, to reduce the number of false positives.
It would be highly advantageous to screen all patients for epithelial cancer during routine office visits, such as visits to dental offices for teeth cleaning, etc. However, methods of screening for epithelial cancer such as the Mashberg procedure have not achieved routine use, partly because the mixing, measuring and dispensing the solutions required is too time consuming to be done for each patient by the dentist and such procedures require some training and experience beyond that normally possessed by para-professional assistants.
It would therefore be desirable to provide an improved method for screening patients for epithelial cancer which is simplified and especially adapted to promote routine screening as the adjunct to normal visits by the patient to medical or dental offices for other reasons.
Accordingly, the principal object of the present invention is to provide such improved screening methods.
Yet another object of the invention is to provide apparatus which encourages such routine testing, by minimizing the time and complications which formerly discouraged such routine testing by medical and dental professionals.
These and other, further and more specific objects and advantages of the present invention will be apparent to those skilled in the art from the following detailed description thereof, taken in conjunction with the drawing, which depicts a kit of components assembled in accordance with the principles of one embodiment of the invention.
Briefly, in accordance with the invention, I provide methods and apparatus for screening patients for epithelial cancer.
My method is an improvement of prior art screening methods which include the steps of sequentially applying to suspected cancerous or precancerous sites preselected volumes of at least two liquid testing reagents of preselected concentrations. My improved method comprises providing such reagents to the administering clinician in prepackaged form, each of said reagents packaged to contain the preselected volume thereof at the preselected concentration thereof, to permit direct dispensation of each such reagent directly from its package for use in accordance with the screening procedure, without further mixing or measuring steps.
In accordance with another embodiment of the invention I provide a diagnostic kit for performing routine screening procedures to detect possible epithelial cancer. Such procedures include the steps of sequentially applying preselected volumes of at least two testing reagents of preselected concentrations to suspected cancerous or precancerous sites. The kit includes a separate package of each of the testing reagents. Each of the packages contains the preselected volume of the reagent in the preselected concentration thereof.
REFERENCES:
patent: 3743088 (1973-07-01), Henkin
patent: 4321251 (1982-03-01), Mashberg
patent: 4977177 (1990-12-01), Bommer et al.
patent: 5018531 (1991-05-01), Hartman
patent: 5112758 (1992-05-01), Fellman et al.
patent: 5240415 (1993-08-01), Haynie
patent: 5372801 (1994-12-01), Malmros et al.
Drummond & Duckworth
Wallenhorst Maureen M.
Zila, Inc.
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