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US3856930A Expired / Lapsed US ⏱️ 0.0 years remaining

Method of screening tissue specimens for diagnostic examination

Assignee: Bio Digital Sciences Inc
•
Filing: 1972-08-16
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Granted: 1974-12-24
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Expires: 1992-08-16
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Abstract

Abstract A process is provided for expediting the diagnosis of an array of tissue specimens suspected of being diseased by eliminating from the array a large portion of the clearly disease-free specimens so that only a relatively small number of specimens need be examined closely for the presence or absence of disease. In the process, a specimen of cells is homogenized after extraneous cellular material such as protein is removed. A predetermined quantity of cells is counted and separated from the specimen and are treated with a radioactive dye which corresponds to the nature of the disease to be diagnosed. The cells uptake the dye in relation to their condition of health, i.e., diseased cells take up more dye and hence radioactive material than normal cells. The excess radioactive material is rinsed from the quantity of cells, and the quantity is solubilized. The level of radioactivity of the specimen cells is sensed and is compared with the level of radioactivity of a normal cell sample which had been identically prepared to obtain a ratio. If the level of activity is below a prescribed ratio, as determined empirically, the specimen need not receive further examination.

Inventors

  • 👤 J Nodine
  • 👤 M Fletcher
  • 👤 J Waite
  • 👤 H Waite

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-01 03:04
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/58; G01N33/60; B; B07; B07C; B07C5/00; B07C5/34; B07C5/346

Claims Analysis

Total Claims: 16
Claim 1
Independent Claim 211 words
IN A PROCESS FOR DIAGNOSING SPECIMENS OF CELLS FOR DISEASE EMPLOYING THE PROCESS KNOWN PER SE OF STAINING A SPECIMEN OF CELLS WITH A RADIOACTIVELY TAGGED DYE, RINSING EXCESS RADIACTIVE DYE MATERIAL FROM THE SEPECIMEN OF CELLS, SENSING THE LEVEL OF RADIOACTIVITY EMITTED BY THE SEPECIMEN OF CELLS, COMPARING THE RADIOCTIVITY EMITTED BY THE SPECIMEN OF CELLS RELATIVE TO A STANDARD OF COMPARISON OBTAINED BY HAVING MEASURED THE LEVEL OF RADIOACTIVITY EMITTED BY A SIMILAR KIND OF SPECIMEN OF CELLS KNOWN TO BE NORMAL, AND REJECTING FROM DETAINED DIAGNOSIS CONSIDERATION OF THAT SPECIMEN OF CELLS IF ITS LEVEL OF RADIOACTIVITY IS LESS THAN A PREDETERMINED LEVEL OF ACTIVITY, WHEREBY SPECIMENS ARE SCREENED PRIOR TO DIAGNOSTIC EXAMINATION TO REDUCE THE NUMBER OF SPECIMENS TO BE EXAMINED, THE IMPROVEMENT COMPRISING, PRIOR TO STAINING, CONTING-OUT A PREDETERMINED QUANTITY OF CELLS FROM A SPECIMEN TO BE DIAGNOSED, ADDING A PREDETERMINED QUANTITY OF RADIOACTIVE DYE MATERIAL TO THE PREDETERMINED QUANTITY OF CELLS IN RELATION TO THE NUMBER OF CELLS COUNTED, AND PERFORMING AT LEAST THE STEP OR STEPS INVOLVING RADIOACTIVE MEASUREMENT WITH THE PREDETERMINED QUANTITY OF CELLS REMOVED FROM SUPPORTING OR SURROUNDING MATTER IN WHICH STAINING WAS ACCOMPLISHED SO THAT ANY SUPPORTING OR SURROUNDING MATTER WHICH MIGHT HAVE BEEN SUBJECT TO EXCESS STAIN HAS BEEN REMOVED.
Claim 2
Dependent Claim 211 words
IN A PROCESS FOR DIAGNOSING SPECIMENS OF CELLS FOR DISEASE EMPLOYING THE PROCESS KNOWN PER SE OF STAINING A SPECIMEN OF CELLS WITH A RADIOACTIVELY TAGGED DYE, RINSING EXCESS RADIACTIVE DYE MATERIAL FROM THE SEPECIMEN OF CELLS, SENSING THE LEVEL OF RADIOACTIVITY EMITTED BY THE SEPECIMEN OF CELLS, COMPARING THE RADIOCTIVITY EMITTED BY THE SPECIMEN OF CELLS RELATIVE TO A STANDARD OF COMPARISON OBTAINED BY HAVING MEASURED THE LEVEL OF RADIOACTIVITY EMITTED BY A SIMILAR KIND OF SPECIMEN OF CELLS KNOWN TO BE NORMAL, AND REJECTING FROM DETAINED DIAGNOSIS CONSIDERATION OF THAT SPECIMEN OF CELLS IF ITS LEVEL OF RADIOACTIVITY IS LESS THAN A PREDETERMINED LEVEL OF ACTIVITY, WHEREBY SPECIMENS ARE SCREENED PRIOR TO DIAGNOSTIC EXAMINATION TO REDUCE THE NUMBER OF SPECIMENS TO BE EXAMINED, THE IMPROVEMENT COMPRISING, PRIOR TO STAINING, CONTING-OUT A PREDETERMINED QUANTITY OF CELLS FROM A SPECIMEN TO BE DIAGNOSED, ADDING A PREDETERMINED QUANTITY OF RADIOACTIVE DYE MATERIAL TO THE PREDETERMINED QUANTITY OF CELLS IN RELATION TO THE NUMBER OF CELLS COUNTED, AND PERFORMING AT LEAST THE STEP OR STEPS INVOLVING RADIOACTIVE MEASUREMENT WITH THE PREDETERMINED QUANTITY OF CELLS REMOVED FROM SUPPORTING OR SURROUNDING MATTER IN WHICH STAINING WAS ACCOMPLISHED SO THAT ANY SUPPORTING OR SURROUNDING MATTER WHICH MIGHT HAVE BEEN SUBJECT TO EXCESS STAIN HAS BEEN REMOVED.
Claim 3
Dependent Claim 70 words
A process according to claim 1 including performing the identical steps to be performed on the predetermined quantity of cells on a disease-free standard normal sample consisting of the same quantity of cells as the predetermined quantity, and which in fact determines the size of the predetermined quantity, to afford a standard of comparison and using the radiation level of said disease-free sample as an actual standard of direct comparison.
Claim 4
Dependent Claim 32 words
A process according to claim 2 wherein said performing step of counting, adding, rinsing, and sensing of said standard normal sample is repeated periodically with respect to corresponding steps on said specimen.
Claim 5
Dependent Claim 71 words
A process according to claim 2 wherein the level of radioactivity emitted by the predetermined quantity of cells defines a ratio with the corresponding level of the standard normal sample, said ratio being determined by dividing the level of radioactivity of the predetermined quantity of cells by the level of radioactivity of the standard normal sample, and said prescribed level in said rejecting step being a ratio of at least 1.4.
Claim 6
Dependent Claim 21 words
A process according to claim 1 including the step of homogenizing the predetermined quantity of cells before performing said counting step.
Claim 7
Dependent Claim 26 words
A process according to claim 5 including the step of removing extraneous cellular material which may include protein and nucleoprotein from said predetermined quantity of cells.
Claim 8
Dependent Claim 29 words
A process according to claim 6 wherein said step of removing extraneous cellular material includes the step of treating the predetermined quantity of cells with cell-dispersing agents including enzymes.
Claim 9
Dependent Claim 25 words
A process according to claim 1 wherein said radioactive sensing step includes the step of solubilizing said predetermined quantity of cells before sensing the radioactivity.
Claim 10
Dependent Claim 19 words
A process according to claim 8 wherein a fluid capable of emitting photons is employed in said solubilizing step.
Claim 11
Dependent Claim 27 words
A process according to claim 1 including the steps of withdrawing a quantity of specimen-cells prior to said counting step and preserving the same for further consideration.
Claim 12
Dependent Claim 50 words
A process according to claim 10 wherein said predetermined quantity of cells is obtained from one of the human female reproductive organs, and including the steps of subsequently diagnostically examining the withdrawn predetermined quantity of cells if the level of radioactivity in said rejecting step is above said prescribed level.
Claim 13
Dependent Claim 15 words
A process according to claim 11 wherein said female organs include cervices, uteri, and vaginae.
Claim 14
Dependent Claim 17 words
A process according to claim 12 wherein said radioactive dye material includes tritiated Pyronin B (3H-Pyronin B).
Claim 15
Dependent Claim 17 words
A process according to claim 12 wherein said radioactive dye material includes tritiated methylene blue (3H-methylene blue).
Claim 16
Dependent Claim 102 words
A process according to claim 11 wherein said predetermined quantity of cells is contained in a solution and said radioactive dye material employed in said adding step includes a selected one of 3H-Pyronin B and 3H-methylene blue each having a specific activity of 0.8 to 3.0 mc/mg with said selected dye being buffered at a pH in a range of about 5.0 to about 7.0 at a temperature in a range of about 20* C to about 37* C for about 5 to 10 minutes and having a concentration in a range of about 1 to about 3 mg/100 ml of solution.

References Cited (Backward Citations)

US3673410A Cited
US3678148A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1977-12-23 1978-06-24 1978-12-24 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1981-12-23 1982-06-24 1982-12-24 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1985-12-23 1986-06-24 1986-12-24 $7700.00 Window Closed / Lapsed

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