Abstract: This application relates to a device for the local delivery of a substance to a mammary duct by ductal cannulation via an orifice on a nipple, wherein the substance may any substance or combinations of substances, such as for example, compositions capable of forming a solid or semisolid gel within the ducts, a marker, and/or an active agent which is preferably effective in treating and/or preventing breast cancer. More particularly, a device is disclosed comprising a probe for locating the orifice on the nipple, wherein the device is further configured to cannulate the duct and allow local delivery of a substance(s).

Abstract: This application relates to a device for the local delivery of a substance to a mammary duct by ductal cannulation via an orifice on a nipple, wherein the substance may any substance or combinations of substances, such as for example, compositions capable of forming a solid or semisolid gel within the ducts, a marker, and/or an active agent which is preferably effective in treating and/or preventing breast cancer. More particularly, a device is disclosed comprising a probe for locating the orifice on the nipple, wherein the device is further configured to cannulate the duct and allow local delivery of a substance(s).

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

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.

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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.