University of California

Cytyc Health Corporation

Pro Duct Health, Inc.

Susan M Love

David T Hung

Julian N Nikolchev

Sanford H Barsky

Shawn O'Leary

Chris Ken

Eyal S Ron

William R George

Hui Cen

Xuanmin He

Mary L Alpaugh

Tina Patel

Annette Bianchi

Linda Gont

Methods for performing medical procedures within the duct of a breast are described. An exemplary embodiment of the invention includes the steps of introducing a guiding member into a breast duct; introducing and positioning a member having an internal lumen in the breast duct; introducing a wash fluid into the breast duct through the internal lumen; removing washings from the breast duct through the internal lumen; and collecting the washings for cytological analysis.

Methods for performing medical procedures within a breast duct

Methods, systems, and kits for treating breast tissue rely on transferring energy to or from cells lining an individual breast duct. Energy can be introduced into the breast duct, e.g., by filling the duct with an electrically conductive medium and applying radiofrequency energy to the medium. Other energy forms could also be used, such as light, ultrasound, radiation, microwave energy, heat, cold, direct current, and the like. By treating individual breast ducts, cancerous and pre-cancerous conditions originating in the duct can be effectively treated.

Methods and systems for treating breast tissue

The invention is to methods for screening women for breast cancer and precancer by determining a level of an estrogen-related marker. The invention further provides methods of treating such patients identified as having one or more abnormal ductal epithelial cells and an estrogen-related marker. The invention provides methods for screening patient for hormone replacement therapy (HRT), and of monitoring such patients once they begin HRT. The invention provides methods of treating peri-, menopausal or postmenopausal women for both cancer risk reduction and menopausal symptoms (or other conditions related to lowered systemic estrogen levels). The invention also provides kits for the screening, monitoring, and treating methods described.

Identifying, monitoring, and treating women for breast precancer or cancer

The invention is to methods for identifying asymptomatic patients who have a likelihood of benefiting from administration of an estrogen activity modulator for risk reduction or therapeutic treatment of breast cancer, methods for reducing risk or therapeutically treating these asymptomatic patients, and methods for monitoring the treatments.

Methods for identifying treating or monitoring asymptomatic patients for risk reduction or therapeutic treatment of breast cancer

Differentiating breast ducts for cancer risk status is a key element in a procedure to screen women for breast cancer. The 6 to 9 breast ducts on the human breast can be differentiated to identify those of higher risk for cancer. The higher risk ducts merit access and analysis of the ductal fluid and monitoring and/or treatment.

Method and kits for differentiating breast ducts for cancer risk status

The invention is a gel composition for delivery to a breast milk duct prior to surgical excision of breast tissue including cancerous lesions. The invention also provides methods of mapping all or nearly all of a breast milk duct prior to surgical excision of breast tissue, and method of identifying part or all of a breast duct or ducts as a surgical aide to a breast surgeon. Kits to support these methods and including these compositions are also provided.

Gel composition for filling a breast milk duct prior to surgical excision of the duct or other breast tissue

Methods, kits, and apparatus for obtaining cellular, chemical, and other materials from breast ducts are described. A single milk duct is accessed and washed with a washing fluid to obtain marker materials from the lining the duct. The washing fluid is then collected, and the marker materials in the washing fluid identified and analyzed. Usually, the washing fluid is introduced using a syringe through a lumen of a dual-lumen catheter. The ductal volume is filled with the washing fluid and excess fluid flows outwardly through a second lumen of the dual-lumen catheter, from which it is collected. Methods and kits provide for collection of fluid and cells by a lavage procedure that includes applying external pressure to the breast to improve the yield of fluid and cells from the breast duct.

Methods using pressure to obtain fluids and cellular material from breast ducts

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.

Methods and kits for identifying ductal orifices in a nipple

Devices, methods and kits for identifying a breast milk duct orifice capable of yielding fluid or releasing a keratin plug under a vacuum are described and claimed. The devices include a magnification lens integral to a nipple aspiration device or a nipple aspiration device having an attachment element for attaching a magnification tool to aid the practitioner to better observe a nipple surface under a vacuum. The devices also can include one or more access ports for such purposes as accessing the duct, marking the duct, or collecting fluid from the duct. The methods of nipple aspiration comprise identifying a duct that yields fluid or releases a keratin plug under a vacuum. The kits can comprise a device of the invention, a container for the kit contents, and instructions.

Devices and methods to identify ductal orifices during nipple aspiration

Methods, kits, and apparatus for obtaining cellular, chemical, and other materials from breast ducts are described. A single milk duct is accessed and washed with a washing fluid to obtain marker materials from the lining the duct. The washing fluid is then collected, and the marker materials in the washing fluid identified and analyzed. Usually, the washing fluid is introduced using a syringe through a lumen of a dual-lumen catheter. The ductal volume is filled with the washing fluid and excess fluid flows outwardly through a second lumen of the dual-lumen catheter, from which it is collected.

Method and kit for obtaining fluids and cellular material from breast ducts

Methods, kits, and apparatus for locating, labelling, and accessing breast ducts are described. An orifice to one or more ductal networks 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; E cadhedrin; and epithelial membrane antigen. Labelling of the ductal orifices permits reliable identification and access to each of the multiple ductal networks which may be present in an individual breast.

Growing community of inventors

Pacific Palisades, CA, United States of America

Susan M Love