Methods and kits for indentifying ductal orifices in a nipple

Abstract

Methods, kits, and apparatus for locating, labelling, and accessing breast ducts are described. An orifice to one or more ductal networks is marked to enhance visibility. In a first embodiment, the orifice is labelled using a specific binding substance, typically an antibody, specific for a tissue marker present on the orifice. Exemplary tissue markers include those present on the ductal epithelium, such as cytokeratins, including cytokeratin 8 and cytokeratin 18; cadhedrins, such as E cadhedrin; and epithelial membrane antigens. In a second embodiment, a dye is injected into the base of the nipple and preferentially accumulates at at least some of the orifices. Other marking techniques are also described. Marking of the ductal orifices permits reliable identification and access to each of the multiple ductal networks which may be present in an individual breast.

Description

[0001] This application is a continuation-in-part of application Ser. No. 08 / 931,786, filed on Sep. 16, 1997, the full disclosure of which is incorporated herein by reference.[0003] 1. Field of the Invention[0004] The present invention relates generally to medical methods and devices for accessing body lumens and in particular to methods and apparatus for identifying ductal orifices in human breasts and accessing the ducts through the identified orifices.[0005] Breast cancer is the most common cancer in women, with well over 100,000 new cases being diagnosed each year. Even greater numbers of women, however, have symptoms associated with breast diseases, both benign and malignant, and must undergo further diagnosis and evaluation in order to determine whether breast cancer exists. To that end, a variety of diagnostic techniques have been developed, the most common of which are surgical techniques including core biopsy and excisional biopsy. Recently, fine needle aspiration (FNA) cyt...

AI Technical Summary

Benefits of technology

[0012] Broadly, the present includes a wide variety of techniques for transiently marking and locating individual orifices in a nipple of a breast, usually a human breast. By "marking," it is meant that a substance, label, energy, or stimulus is applied to the nipple to cause labelling, a reaction, or other response which permits or enhances distinguishing an orifice from surrounding tissue in the nipple. Usually, but not necessarily, the methods will result in the marking of all orifices in a nipple to permit subsequent access to all or selected one(s) of the ductal networks associated with the orifices. The marking will be "transient," e.g. will not be permanent but instead will remain visible or otherwise detectable for a time sufficient to permit subsequent access to the associated ductal lumens, usually for a period of at least 15 minutes, preferably for about 1 to 2 hours. For the most part, the present invention will rely on introducing a detectable substance, such as a labelling reagent, dye, or the like, to the nipple so that the substance localizes and / or accumulates at or near the orifice to permit visual, automated, or other detection. Alternatively, the present invention can utilize other stimuli for inducing a response, change, or reaction at or near a location of the orifice in the nipple. For example, it may be possible to illuminate the nipple with certain light or other energies which help distinguish between the orifice and other tissue surfaces. It may also be possible to introduce chemical reagents which react with ductal secretions at the orifice to enhance visibility e.g. to produce a visible or otherwise detectable reaction product.

Problems solved by technology

Regardless of the correctness of this presently believed mechanism, it has been found that introduction of a dye into the base of a nipple results in subsequent accumulation of the dye at at least some of and usually all of the ductal orifices.

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