CA2131164A1 - Method and kit for epithelial cancer screening - Google Patents

Method and kit for epithelial cancer screening

Info

Publication number
CA2131164A1
CA2131164A1 CA002131164A CA2131164A CA2131164A1 CA 2131164 A1 CA2131164 A1 CA 2131164A1 CA 002131164 A CA002131164 A CA 002131164A CA 2131164 A CA2131164 A CA 2131164A CA 2131164 A1 CA2131164 A1 CA 2131164A1
Authority
CA
Canada
Prior art keywords
preselected
reagents
epithelial cancer
kit
screening
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002131164A
Other languages
French (fr)
Inventor
Pier J. Cipriani
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zila Biotechnology Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to JP6516458A priority Critical patent/JPH07507812A/en
Priority to PCT/US1993/000352 priority patent/WO1994016325A1/en
Priority to CA002131164A priority patent/CA2131164A1/en
Priority to AU34740/93A priority patent/AU696368B2/en
Priority to EP93903503A priority patent/EP0636246A1/en
Publication of CA2131164A1 publication Critical patent/CA2131164A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B10/0051Devices for taking samples of body liquids for taking saliva or sputum samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/001Preparation for luminescence or biological staining
    • A61K49/006Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/0413Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid or semi-rigid and the outer container being of polygonal cross-section formed by folding or erecting one or more blanks, e.g. carton
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0051Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by rotation
    • A61B2050/0056Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by rotation about a lateral axis in the lid plane
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/31Carrying cases or bags, e.g. doctors' bags
    • A61B2050/311Cases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Mechanical Engineering (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Pulmonology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Biodiversity & Conservation Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Optics & Photonics (AREA)
  • Epidemiology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

2131164 9416325 PCTABS00033 A diagnostic kit and method for performing routine screening procedures to detect possible epithelial cancer. The kit includes prepackaged reagents, containing preselected volumes at preselected concentrations to permit direct dispensation of each of the reagents directly from its package without further mixing or measuring steps.

Description

WO ~41~6325 -1- z~31~ 64 Ycrlusg3lao352 METHOD AND KIT FOR EPITHELIAL CANCER SCREEMING

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 ~or epithelial cancer, which can be used by medical personnel without highly ~pecialized kraining.

' 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, wi~hout : ~ reguiring time-consuming or complicated mixing-storage-dispensing-measuring steps.~

~ Various:procedures are kn~wn for screening patients for ;
epithelial cancer, es~ecially 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 t~issues, 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 :

W094/l~25 Z13~ PCT~S93100352
-2-Mashberg involves sequential washes, rinses and applications of water, diluted acetic acid and a solution of toluidine ~lue-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 a~hieved routine use, partly because the mixing, measuring and dispensihg the solutions re~uired is too time consuming to be done for each patient by the dentist and such proaedures: require some training and experience beyond that normally possessed by para-professional :~ assistants.

It would therefore be desirable:to:provide an~improved :
~2~0:: : ~ethod: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.

:: :: :
~ Z5 : Accordingly, the principal object of the present : invention is to provida such improved screening methsds.

~' W094/1~25 PCT~S93/~0352 213~

Yet another object of the invention is to provide apparatus which encourages such routine testing, by minimizing the time and co~plications which formerly di~couraged such routine testing by medical and dental profes~ionals.

These and other, further and more specific objects and advantages o~ the present invention will be apparent to those skilled in khe art from the following detailed description thereof, taken in conjunction with the drawing, which depicts a kit of components assembled: in accordance with ~he principles of one e~bodiment of the invention.

Briefly, in accordance with the invention, I provide : methods and ~apparatus for ~creening patients for epithelial :: 15~ cancer.

~ y method is an:improvement of~ prior art screening methods which includ~e~the steps of sequentially applying to suspected canoerous or precancerous æites pres~lected vo~umes 20 of at l~aBt two liquid~ testing reagents of preselected : ~ concentrations. `My:improved~method comprises providing such ~ reagents to the administering clinician in prepackaged form, ;, each of said reage,nts ~e packaged to contain the preselected volume thereof at the~preselec~ed ooncentration thereof, to permit~direct dispensation of each uch~reagent directly from its pa~kage for use ~in accordance with the screening procedure, without :further mixing or measuring steps.

W094/1~5 2~311~ PCT~S93/00352 In accordance with another embodiment of the invention I provide a diagnostic kit for performing routine screening procedur~s to detect possible epithelial cancer. Such procedures include the steps cf se~uentially applying preselected volumes of at least two testing reagents of preselected concentrations to suspected cancerou~ 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.

The drawing depicts a kit constructed in accordance with :
the principles of the invention, in this case for carrying out ~ the Mashberg screening pr~cedure. The kit can is conveniently contained in a single box I0 which contains all of the : components necessary for screening a single patient for oral apithelial cancer. The components include three bottles 11, 12 and 13, with single use cups. Bottle 11 contains lOcc of a pre-rinse solution;~hich is a 1% solution of ace~ic ac d, used to adjust the~Ph:of the oral ca~ity and wash away food :: particles and the like. Bottle 12 contains lO cc. o~ a 1%
:
s~lution of ~oluidine blue-O. Bottle 13 contains 30 cc. of 1% ac~tic acid solution post-rinse, which i5 us~d to remove excess toluidine blue-O 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 W094ll63~s Z ~

15, cups 16 for administering water washes a~d a clinical information reply card 17 which is used to confirm the ~ffectiveness 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 ~0 ~pecific 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, I CLAI~: :

Claims (2)

Claims:
1. In 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 testing reagents of preselected concentrations, the improvement comprising 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 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.
2. 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, said kit including a separate package of each of said testing reagents, each said package containing said preselected volume said reagent in the preselected concentration thereof.
CA002131164A 1993-01-14 1993-01-14 Method and kit for epithelial cancer screening Abandoned CA2131164A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP6516458A JPH07507812A (en) 1993-01-14 1993-01-14 Screening method for epithelial cancer and kit for the screening
PCT/US1993/000352 WO1994016325A1 (en) 1993-01-14 1993-01-14 Method and kit for epithelial cancer screening
CA002131164A CA2131164A1 (en) 1993-01-14 1993-01-14 Method and kit for epithelial cancer screening
AU34740/93A AU696368B2 (en) 1993-01-14 1993-01-14 Method and kit for epithelial cancer screening
EP93903503A EP0636246A1 (en) 1993-01-14 1993-01-14 Method and kit for epithelial cancer screening

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/US1993/000352 WO1994016325A1 (en) 1993-01-14 1993-01-14 Method and kit for epithelial cancer screening
CA002131164A CA2131164A1 (en) 1993-01-14 1993-01-14 Method and kit for epithelial cancer screening

Publications (1)

Publication Number Publication Date
CA2131164A1 true CA2131164A1 (en) 1994-07-21

Family

ID=25677465

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002131164A Abandoned CA2131164A1 (en) 1993-01-14 1993-01-14 Method and kit for epithelial cancer screening

Country Status (5)

Country Link
EP (1) EP0636246A1 (en)
JP (1) JPH07507812A (en)
AU (1) AU696368B2 (en)
CA (1) CA2131164A1 (en)
WO (1) WO1994016325A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2214829C (en) * 1996-01-16 2002-05-14 Edwin Pomerantz Methods and compositions for in-vivo detection of oral cancers and precancerous conditions
US6967015B1 (en) * 2000-07-20 2005-11-22 Zila, Inc. Diagnostic method for detecting dysplastic epithelial tissue

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3743088A (en) * 1971-01-18 1973-07-03 R Henkin Diagnostic device and method of treatment
US4321251A (en) * 1979-12-19 1982-03-23 The United States Of America As Represented By The Department Of Health And Human Services Detection of malignant lesions of the oral cavity utilizing toluidine blue rinse
US4977177A (en) * 1985-04-30 1990-12-11 Nippon Petrochemicals Company, Ltd. Tetrapyrrole polyaminomonocarboxylic acid therapeutic agents
US5018531A (en) * 1989-09-07 1991-05-28 Hartman William B Skin blemish measuring and recording system and method
US5116328A (en) * 1990-07-16 1992-05-26 Oclassen Pharmaceuticals, Inc. Diagnostic kit for the detection of atypical epithelia

Also Published As

Publication number Publication date
AU3474093A (en) 1994-08-15
AU696368B2 (en) 1998-09-10
EP0636246A4 (en) 1995-03-08
WO1994016325A1 (en) 1994-07-21
EP0636246A1 (en) 1995-02-01
JPH07507812A (en) 1995-08-31

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued