Abstract: The invention provides devices, kits and methods for delivering an agent to a breast milk duct. Intraductal agent delivery provides an opportunity to treat a breast condition locally and avoid the pitfalls of systemic drug delivery for a local condition. Time-released agents delivered into the ducts using an intraductal device or formulation reduces the frequency of intraductal administration required for desired efficacy over time. The methods include methods of treating a breast condition, including the conditions of cancer or precancer.

Abstract: 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.

Abstract: An expandable medical dilator used for dilating a body opening during or in preparation for the performance of a medical procedure. The dilator comprises an outer wall for positioning against an inner surface of the body opening as the opening is dilated and an inner wall defining an internal lumen for receiving a medical instrument used to perform the medical procedure. The dilator also includes at least one expansion region. In one embodiment, the expansion region extends from the proximal end to the distal end of the dilator. In another embodiment, the expansion region extends from a position along the length of the dilator to the distal end. In either embodiment, the expansion region can include at least one opening or a plurality of spaced perforations.

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: A catheter used to deliver or retrieve material from within a body. The catheter comprises a proximal end, a distal end and a central section extending between the proximal end and the distal end. The catheter also includes an internal lumen that extends from the proximal end to the distal end through the central section. The distal end includes a rigid bulbous tip with an outer diameter that is greater than an outer diameter of the central section. The rigid bulbous tip has a rounded, substantially spherical shape that is safer than the distal end of a traditional catheter. The bulbous tip does not include any sharp edges that could tear or otherwise perforate a passageway within a patient. As a result, the catheter is safer and it can be advanced within the patient without causing pain or injury.

Abstract: The invention provides methods, devices and systems for collecting breast ductal fluid comprising cellular material and other useful markers for analysis. The methods typically comprise access of at least one breast duct and collecting materials from that duct separate from all other ducts in the breast. The devices comprise ductal access devices that provide the opportunity to collect fluid from a single duct separate from all the other ducts in the breast. The systems employ the methods and devices that used together provide systems for analysis of a breast condition in a patient specific to accessed breast ducts. The methods, devices and systems are particularly useful for identification of breast precancer or cancer in within the patient.

Abstract: The invention provides compositions for targeting methylated promoters in breast cancer and pre-cancer patients. The invention also provides methods for intraductal treatment of breast cancer and pre-cancer patients by delivering intraductally an agent that targets methylated promosters of silenced genes.

Abstract: 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.

Abstract: The invention provides methods that increase retrievable fluid from a breast duct of a patient. Later a portion of the increased fluid reservoir can be collected for analysis, or analyzed in situ. Ductal fluid typically contains ductal epithelial cells and other markers that can aid in identifying a breast condition, including breast cancer and precancer.

Abstract: Apparatus, methods and kits for simultaneous delivery of a fluid or other substance to two or more breast milk ducts are provided. The fluid can be delivered for a variety of purposes including lavage of the ducts and administering an agent for therapeutic, prophylactic, or diagnostic purposes.

Abstract: The invention provides methods, devices and systems for collecting breast ductal fluid comprising cellular material and other useful markers for analysis. The methods typically comprise access of at least one breast duct and collecting materials from that duct separate from all other ducts in the breast. The devices comprise ductal access devices that provide the opportunity to collect fluid from a single duct separate from all the other ducts in the breast. The systems employ the methods and devices that used together provide systems for analysis of a breast condition in a patient specific to accessed breast ducts. The methods, devices and systems are particularly useful for indentification of breast precancer or cancer in patient.

Abstract: Apparatus, methods and kits for simultaneous delivery of a fluid or other substance to two or more breast milk ducts are provided. The fluid can be delivered for a variety of purposes including lavage of the ducts and administering an agent for therapeutic, prophylactic, or diagnostic purposes.

Abstract: 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.

Abstract: Methods and systems for identifying a virus in breast ducts are provided. In addition, antiviral therapy for treating a virally infected breast duct is also provided. Patients with a viral infection identified in the breast ducts may be at risk for developing breast precancer or cancer.

Abstract: Methods, compositions and systems for preparing a breast for breast duct fluid collection are described.

Abstract: A method and apparatus for obtaining prostatic material by introducing a washing fluid to a prostatic portion of a urethra and collecting at least a portion of the washing fluid comprising prostatic material for 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: The invention provides devices, methods and systems for retrieving and analyzing a sample of breast duct fluid (including ductal epithelial cells and other ductal contents) for the purpose of diagnosing a breast condition, including the conditions of cancer or precancer. All or part of the analysis can be conducted in situ. The items analyzed can be quantified.

Abstract: The invention provides methods, devices and systems for collecting breast ductal fluid comprising cellular material and other useful markers for analysis. The methods typically comprise access of at least one breast duct and collecting materials from that duct separate from all other ducts in the breast. The devices comprise ductal access devices that provide the opportunity to collect fluid from a single duct separate from all the other ducts in the breast. The systems employ the methods and devices that used together provide systems for analysis of a breast condition in a patient specific to accessed breast ducts. The methods, devices and systems are particularly useful for indentification of breast precancer or cancer in patient.

Abstract: 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.