Devices, methods and systems for collecting material from a breast duct

A method for obtaining cellular material from a human breast milk duct, said method comprising:

• introducing a ductal access device having at least one lumen therethrough into a duct;
• introducing a wash fluid through the access device lumen into the milk duct, wherein a volume of at least 2 ml is present within the duct for a preselected time;
• and
• collecting at least a portion of the wash fluid from the duct through the lumen of the access device.

A method for obtaining cellular material from a human breast milk duct, said method comprising:

• introducing a wash fluid to the breast milk duct, wherein the wash fluid is present within the duct for a preselected time;
• and
• collecting at least a portion of the introduced wash fluid from within the duct, wherein said portion carries the cellular material;
• wherein the wash fluid is introduced to a single breast milk duct and collected from the same breast milk duct without mixing with materials from other breast milk ducts.

A method for obtaining cellular material from a human breast milk duct, said method comprising:

• introducing a ductal access device having at least one lumen therethrough into a duct;
• introducing a wash fluid through the access device lumen into the milk duct, wherein the wash fluid is present within the duct for a preselected time;
• and
• collecting at least a portion of the wash fluid from the duct through the lumen of the access device;
• wherein the wash fluid is introduced to a single breast milk duct and collected from the same breast milk duct without mixing with materials from other breast milk ducts.

A ductal access device comprising:

• an access tube having a distal end, a single lumen therethrough, and dimensions which permit introduction of the distal end through a ductal orifice and positioning a distal end thereof distal to the ductal sphincter.
• an infusion connector providing a fluid flow path into the lumen of the access tube;
• and
• a collection connector providing a fluid outlet path from the lumen of the access tube, said infusion and collection connectors being isolated from each other so that fluid may be infused through the infusion connector and simultaneously removed through the collection connector.

A ductal access catheter comprising:

• a catheter body having a distal end and a proximal end and including at least a distal portion and a proximal portion;
• wherein the distal portion has a cross-sectional geometry which can be inserted through a ductal orifice into a ductal lumen of a human breast;
• wherein the proximal portion has a cross-sectional geometry which inhibits insertion through the ductal orifice and into the ductal lumen;
• and
• wherein the catheter body has at least an infusion lumen and an collection lumen each of which has a distal port near a distal end of the distal portion and a proximal connector near a proximal end of the proximal portion.

A ductal access catheter comprising:

• a catheter body having a distal end and a proximal end and including at least a distal portion and a proximal portion;
• wherein the distal portion has a cross-sectional geometry which can be inserted through a ductal orifice into a ductal lumen of a human breast;
• wherein the distal portion of the catheter body is stiffened over at least a part of its length to facilitate insertion through the ductal orifice and into the ductal lumen;
• and
• wherein the catheter body has at least an infusion lumen and an collection lumen each of which has a distal port near a distal end of the distal portion and a proximal connector near a proximal end of the proximal connector.

A ductal access catheter comprising:

• a catheter body having a distal end and a proximal end and including at least a distal portion and a proximal portion;
• wherein the distal portion has a cross-sectional geometry which can be inserted through a ductal orifice into a ductal lumen of a human breast;
• and
• wherein the catheter body has at least an infusion lumen and an collection lumen each of which has a distal port near a distal end of the distal portion and a proximal connector near a proximal end of the proximal connector;
• and
• wherein the distal collection port and the distal infusion port are both located on the side of the distal portion of the catheter body.