AU725540B2 - Method and kit for epithelial cancer screening - Google Patents

Description

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AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT

ORIGINAL

Applicant(s): ZILA, INC.

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0 S 0 Actual Inventor(s): Pier J Cipriani Address for Service: PATENT ATTORNEY SERVICES 26 Ellingworth Parade Box Hill Victoria 3128 Australia Title: METHOD AND KIT FOR EPITHELIAL CANCER SCREENING S S Associated Provisional Applications: No(s).: The following statement is a full description of this invention, including the best method of performing it known to me/us:- 1 r "I r, WO94/16325 PCTIUS93100352 -1- METHOD AND KIT FOR EPITHELIAL CANCER SCREENING 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.

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15 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-storagedispensing-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. patent to Mashberg No.

4,321,251 discloses such a procedure. The procedure of i WO 94/16325 PCTIUS93100352 -2- 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-applicationrinse-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 •go experience beyond that normally possessed by para-professional S00 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.

0 Accordingly, the principal object of the present Sinvention is to provide such improved screening methods.

invention is to provide such improved screening methods.

-3- 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.

In accordance with the invention there is provided a method of screening patients for oral epithelial cancer by an administering clinician, according to a procedure which includes ••co the steps of said clinician sequentially applying to oral tissues effective preselected volumes oooo of at least two liquid testing solutions, a first one of said solutions containing a preselected concentration of staining dye reagent, capable of indicating cancerous or precancerous sites •ooe on oral epithelial tissues and a second one of said solutions containing a preselected concentration of a rinsing reagent, including said solutions being contained in separate packages containing said preselected volumes thereof at said preselected concentrations thereof, to permit said clinician to dispense said solutions for oral application directly from said packages, in accordance with said procedure, without diluting or reconstituting said solutions before application thereof to oral tissue.

The invention also provides a diagnostic kit when used for performing routine screening procedures to detect possible oral epithelial cancer, said procedures including the -3asteps of Sequentially applying to oral tissue effective preselected volumes of at least two liquid testing solutions, a first one of said solutions containing a preselected concentration of a staining dye reagent, capable of indicating suspected cancerous and precancerous sites on oral epithelial tissue and a second one of said solutions containing a preselected concentration of a rinsing reagent, said kit including a separate package for at least said two liquid testing solutions, said package for said solutions containing said preselected volumes thereof, in said preselected concentration thereof, to allow application to oral tissue without prior diluting or reconstituting of the first or second solutions.

Also in accordance with the invention there is provided a method for screening patients for epithelial cancer, according to a procedure which includes steps of sequentially applying to suspected cancerous or precancerous sites preselected volumes of at least two liquid 9999 testing reagents of preselected concentrations with at least one liquid reagent able to 9**9 selectively react with cancerous and precancerous tissue, including providing such reagents o to the administering clinician in prepackaged form, each of said reagents being packaged to 9*99 contain the preselected volume thereof at the preselected concentration thereof, to permit ooo° direct dispensation of each such reagent directly from its package for use in accordance with 9*99 the screening procedure, without further mixing or measuring steps.

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A specific form of the invention comprises a diagnostic kit for performing routine screening procedures to detect possible epithelial cancer, said procedures including the steps of sequentially applying to suspected cancerous or precancerous sites, preselected volumes of at least two testing reagents of preselected concentrations with at least one reagent able to selectively react with cancerous and precancerous tissue, said kit including a separate 3b package of each of said testing reagents, each said package containing said preselected volume said reagent in the preselected concentration thereof Still further there is provided a method for screening patients for oral epithelial cancer by an administering clinician, the method including the steps of providing liquid testing solutions of preselected volumes to an administering clinician in prepackaged form, the liquid testing solutions including, a first solution containing a preselected concentration of a staining dye agent that selectively stains cancerous and precancerous tissue, and a second solution containing a preselected concentration of a rinsing agent; and the clinician sequentially applying to oral tissue the preselected volumes of the first solution and the second solution to the suspected cancerous or precancerous sites of a patient without diluting or reconstituting the first or second solutions prior to their application to oral tissue.

S..In another form there is provided a method for screening patients for oral epithelial Scancer by an administering clinician, according to a procedure which includes the steps of said clinician sequentially applying to oral tissues preselected volumes of at least two liquid testing solutions, a first one of said solutions containing a preselected concentration of staining dye reagent that selectively stains cancerous and precancerous tissue, and a second one of said solutions containing a preselected concentration of a rinsing reagent, including providing at least said first liquid testing solutions to said administering clinician in prepackaged form, wherein at least said first solution is contained in a separate package containing said preselected volume thereof at said preselected concentration thereof, to permit said clinician to dispense at least said first solution for oral application directly from its said package, in accordance with said procedure, without diluting or reconstituting at least said first solution before application thereof to oral tissue.

3c- In yet a further version of the invention there is provided a diagnostic kit for performing routine screening procedures to detect possible oral epithelial cancer, said procedures including the steps of sequentially applying to oral tissue preselected volumes of at least two liquid testing solutions, a first one of said solutions containing a preselected concentration of a staining dye reagent that selectively stains cancerous and precancerous tissue, and a second one of said solutions containing a preselected concentration of a rinsing agent, said kit including a separate package for at least said first solution, said package for said first solution containing said preselected volume thereof, in said preselected concentration thereof My method is an improvement of prior art screening methods which includes the steps of sequentially applying to suspected cancerous or precancerous sites preselected volumes of •toe 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 be 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 m uge :measuring steps.

a -4- 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.

EXAMPLE 1 The drawing depicts a kit constructed in accordance with the principles of the invention, in this case for carrying out the Mashberg screening procedure. The kit can is conveniently contained in a single box 10 which contains all of the o. components necessary for screening a single patient for oral

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epithelial cancer. The components include three bottles 11, 12 and 13, with single use cups. Bottle 11 contains 1Occ of a pre-rinse solution which is a 1% solution of acetic acid, used to adjust the Ph of the oral cavity and wash away food 1 particles and the like. Bottle 12 contains 10 cc. of a 1% oo" solution of toluidine blue-0. Bottle 13 contains 30 cc. of o 1% acetic acid solution post-rinse, which is used to remove excess toluidine blue-0 dye from the mouth. In accordance with the presently preferred embodiment, I also include other optional components in the kit such as an oral diagram sheet 14, on which the clinician can record the location of any suspected cancerous sites for later reference, a patient bib PCTIUS93100352 WO 94/16325 cups 16 for administering water washes and a clinical information reply card 17 which is used to confirm the effectiveness of the procedure.

As will be apparent to those skilled in the art, my invention is not limited to a specific treatment method or specific solutions. Instead, it is generally applicable to any epithelial cancer detection procedures which employ a plurality of testing reagents, without limitation on the specific testing reagents employed.

Having described my invention in such terms as to enable those skilled in the art to understand and practice it, and having identified the presently preferred embodiments thereof, o 0 0 0 0

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Claims (3)

1. A method of screening patients for oral epithelial cancer by an administering clinician, according to a procedure which includes tie steps of said clinician sequentially applying to oral tissues effective preselected volumes of at least two liquid testing solutions, a first one of said solutions containing, a preselected concentration of staining dye reagent, capable of indicating cancerous or precancerous sites on oral epithelial tissues and a second one of said solutions coOnt'ing a preselected concentration of a rinsing :03/06 reagent, including said solutions being contained in separate packages containing said, preselected volumes thereof at said preselected concentrations thereof, to permit said clinician to dispense said solutions for oa application directly from said packages, in accordance with said procedure, without iiluidng or reconstituting said solutions before application thereof to oral tissue.

2. A diagnostic kit when used for perfZiorming routine screening procedures to. detect possible oral epithelial cancer, said procedures including the steps of sequentially applying to oral tissue effective preselected volumes of a .least two liquid testing solutions. T a first one of said solutions containing apreselected concentration of a staining dye reagent, capable of indicating suspected cancerous and precancerous sites on oral epithelial tissue and a second one of said solutions cont rig a preselected concentration of a rinsing reagent, u s i 1 J i! ft 17/08/2000 15: 37 +613-990-13 3 7 PATENT ATT/H&H INSUR PAGE 04/06

7-- said kit including a separate package fo at least said two liquid testing solutions, said package for said solutions containing said preselected volumes thereof, in said preselected concentration thereof, to allow application !?to oral tissue without prior diluting or reconstituting of the first or second solutions. 3. A method for screening patients for epithelial cancer, according to a procedure which includes steps of sequentially applying to ,uspected cancerous or precancerous sites preselected volumes of at least two liquid testinig reagents of preselected concentrations with at least one liquid reagent able to selectively react with cancerous and precancerous tissue, including providing such reagents to the administering clinician in prepackaged form, each of said reagents being packaged to contain the preselected volume thereof at the preselected S 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 00 measuring steps. 15 4. A diagnostic kit for performing rdutir screening procedures to detect possible epithelial cancer, said procedures including the steps of sequentially applying to suspected cancerous or precancerous sites, preselected volumes of at least two testing reagents of 0 preselected concentrations with at least one reagert able to selectively react with cancerous and precancerous tissue, said kit including i separate package of each of said testing reagents, each said package containing said preeected volume said reagent in the preselected concentration thereof. A method for screening patients for oral eoithelial cancer by an administering clinician, the method including the steps of: -oV ~j\J Q<~ 17/ 0O 0 *0 0 00** *0S00S S 08/2000 15:37 +613-9890--1337 6ATENT ATT/H&H INSUR providing liquid testing solutions of pres elec-ted vollumes to an administering clinician in prepackaged form, the liquid testing solutions'fincluding, Sa First solution containing a preseleq ted conecntration of a staining dye agent that selectively stains cancerous and precancerouLs tissue, and Ui. a second solution containing a preselkcted concentration of a rinsing agent; and the clinician sequentially applying to oral tissue the preselected volumes of the first solution and the second solution to the suspect'. cancerous or precancerous sites of a patient without diluting or reconstituting the first or s-cond solutions prior to their application to oral tissue. 6. A mnethod for screening patients for oral pihelial cancer by an administering clinician, according to a procedure which includes the S'iieps of said clinician sequentially applying to oral tissues preselected volumes of at least two, Uqcuid testing solutions, a first one of said solutions containing a preselected concentration of staiiing 1 dye reagent that selectively stains canceroi.s R Fd precancerous tissue, and a second one of said solutions containitng 'a preselected concentration of a rinsing reagent, including providing at least said first liquid testiiig solutions to said administering clinician in prepackaged form, wherein at least said firstrsoluition is contained in a separate package containing said preselected volume thereof af Said preselected concentration thereof;, to permit said clinician to dispense at least said firs(- solution for oral application directly from its said package, in accordance with said procedure, wyithout diluting or reconstituting At least said first solution before application thereof to oral (issue. 4GE o5/e6 17/s 0 00 *0 0 *0 0 40 0000 0 0 0000 V 0 0000 0* 00 4 0 04 00*0 00 00 00 @000 0 0 0000 0 0 0000 00 00 0 00 0000 0 **00 @0 0 *00 000000 8/2000 15:37 +613-9890-1337 1 PATENT ATT/H&H INSURN 7. A diagnostic kit for performing routine cfteening procedures to detect possible oral epithelial canoer, said procedures including ta isteps of sequentially applying,.to; 9,a tissue preselected vol *mes of at least two liquid testiin outos a first one of said solutions containing 0,preselected concentration of a staining dye reagent that selectively stains cancerous, and~ precancerous tissue, and a second one of said solutions containin a preselected concentration of a rinsing agent, said kit including a separate package for at least said first solution, said package for said first solution containing said preselected volume,: thereof, in said preselected concentration thereof 8, A diagnostic kit for performing routine srengprocedures to detect possible epithelial cancer substantially as hereinbefore desciibed with reference to Example 1 and the drawing. 15 9. A method of screening patients for oral' qpithefial cancer, substantially as hereinibefore described with reference to Example I and the,'drawing Dated this 20th day of July 2000 PATENT ATTORN'EY SERVICES Attorneys for ZILA, INC ~GE 06/06