Chemistry: molecular biology and microbiology – Apparatus
Reexamination Certificate
1998-11-10
2001-05-01
Beisner, William H. (Department: 1744)
Chemistry: molecular biology and microbiology
Apparatus
C435S307100, C378S164000, C378S208000
Reexamination Certificate
active
06225107
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a carrier to maintain an excised tissue specimen such as a breast biopsy specimen in a defined and stable orientation throughout subsequent processing and evaluation.
BACKGROUND
Mammography is a noninvasive screening method for early detection of breast cancer. By pinpointing lesions as small as a few millimeters for further evaluation, mammography is an effective way to detect early-stage breast cancer, leading to increased treatment efficacy and decreased morbidity and mortality. The prevalence of mammography has led to increased follow-up evaluation including surgical biopsies of suspicious lesions or masses.
Among the diagnostic evaluation protocols, gross and microscopic pathological examination of excised suspicious tissues is routinely performed. This often consists of macroscopically examining the intact tissue, then histologically processing the tissue for subsequent microscopic evaluation of one or more stained serial sections. In addition, radiologic evaluation of the tissue, either in an intact form or in serial sections, may be performed.
In evaluating an excised tissue sample for the presence of malignant, pre-malignant or suspicious cells, it is useful if the tissue is maintained in an undistorted manner and in the exact orientation from which it was removed from the body. Maintaining tissue orientation permits a clinician to determine the extent of any malignancy that may be present; for example, if the tissue margins are free from malignant cells, the clinician is given greater assurance that the entire lesion was excised. This lessens the need for subsequent or more invasive surgery or other procedure. In contrast, if the tissue margins contain malignant, pre-malignant or suspicious cells, further surgery may be desirable to ensure that more or all of a mass is removed.
A variety of devices are available for securing and transporting such excised tissues for pathologic and/or radiologic evaluation. For example, tissue samples can be sandwiched and compressed between two plates, with the plates forming a grid for locating a mass within a tissue sample during subsequent radiological and pathological evaluation. As another example, tissue samples may be contained in carriers that have multiple compartments to contain core tissue samples as well as peripheral tissue samples to ensure the core tumor as well as the surrounding tissue is evaluated. As still another example, tissue samples may be contained in molds that vertically orient specimens prior to histological embedding and processing. None of these devices, however, minimize distortion of the tissue and maintain tissue orientation during transport and radiological and/or pathological evaluation so that, for example, accurate assessment of tissue margins may be made.
SUMMARY OF THE INVENTION
The invention is directed to a tissue specimen carrier that minimizes specimen distortion and maintains in vivo orientation of the tissue from excision throughout transport and radiological and/or pathological evaluation. The carrier is a radiographically transparent outer device or box to contain the tissue in a known fixed orientation, with the outer box open at at least one face for receiving a slidably insertable radiographically transparent inner device or box, and the inner box for securing the specimen contained in the outer box. In one embodiment, the carrier has a plurality of apertures at least one surface. The carrier may be appropriately sized to contain a tissue specimen that is in the range of, for example, about one to about five times smaller than the size of the carrier.
The invention also relates to a method of maintaining an excised tissue specimen in a defined and stable orientation relative to its orientation in the body throughout radiologic and/or pathologic evaluation. The specimen may be a breast biopsy specimen.
The invention additionally relates to a method of providing an oriented orthogonal view of an excised tissue from a body for subsequent diagnostic evaluation. The specimen is oriented relative to its location in the body, and is inserted into a carrier and maintained in the fixed oriented position throughout diagnosis.
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Silverstein,Ductal Carcinoma in Situ, Section 17, Pathology of Ductual Carconoma in Situ, p. 190-191, (1997).
Beisner William H.
Wood Herron & Evans LLP
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