Surgery – Miscellaneous – Methods
Reexamination Certificate
1998-07-23
2001-11-06
Isabella, David J. (Department: 3738)
Surgery
Miscellaneous
Methods
C600S567000, C435S040520, C435S040500, C604S500000
Reexamination Certificate
active
06311691
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to breast biopsies in general and, more particularly, to a method for accurately determining the shortest distance between the periphery of a lesion and the cut edge of a tissue specimen.
Breast biopsy evaluation methods by specimen radiography, pathologic examination of inked biopsy specimens and pathologic evaluation of additional tissue removed from the original biopsy bed in the breast (at re-excision or mastectomy) have significant limitations. No method establishes the truth of whether a lesion has been completely excised or not. Specimen radiography is a limited method of assessing completeness of excision while microscopic inspection of slices of the tissue specimen is limited by the method by which pathologists slice surgical specimens. All too often the slicing operation creates a likelihood of error in estimating the margin of excision,(i.e. the true shortest distance between the periphery of the lesion and the cut edge of the specimen). Residual tumor was found at the biopsy site in 33% of biopsies which produced specimens showing apparent complete excision. Lee and Carter,
Detecting Residual Tumor After Excision Biopsy of Impalpable Breast Carcinoma, Am. J. Roentgenology,
1995; 164:81-86.
It is, accordingly, a general object of the invention to provide a method for accurately determining the shortest distance between the periphery of a lesion and the cut edge of the tissue specimen. If the lesion is found to be entirely within the specimen and the shortest distance from the periphery of the lesion to the cut edge of the specimen can be measured, a judgment can be made as to whether the lesion was completely excised.
BRIEF SUMMARY OF THE INVENTION
The shortest distance between the periphery of a lesion and the cut edge of a tissue specimen is determined using a cylindrical tissue specimen. The tissue specimen is placed inside a fixative transmitting cylindrical canister for fixation. Before the specimen is fixed, it can be radiographed to obtain a first estimate of whether the lesion is in the specimen and whether it appears to be completely excised. Once the specimen has been fixed and embedded, it is cross-section sliced in planar slices that are perpendicular to the longitudinal axis of the cylindrical tissue specimen. The tissue slices are mounted on slides for evaluation to select the slide showing the periphery of the lesion nearest to the cut edge of the specimen. The shortest distance between the periphery of the lesion and the cut edge of the specimen is measured. The measured distance can be adjusted for shrinkage artifacts to obtain a true shortest distance between the periphery of the lesion and the cut edge of the specimen.
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Isabella David J.
O'Hara Kelly
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