Abstract: A ductal access device is provided for accessing a breast duct and collecting biological material from within the duct. The access device may include an elongated member having an outer diameter sized for positioning within the breast duct and an internal lumen for infusing a fluid into the breast duct and collecting fluid from the breast duct. The elongated member may include a central axis extending through the internal lumen and a different axis being parallel to the central axis defining an off-axis configuration. An elongated distal tip extends beyond the distal end of the internal lumen and along the different axis. The elongated distal tip has a closed distal end for navigating within the breast duct. The elongated distal tip may include an internal passageway that is sized to slidiably or removably receive an elongated introducer.

Abstract: A medical instrument including a ductal access device comprising a low profile, ergonomic manifold hub usable to introduce fluids into a breast duct and collect ductal fluid samples including ductal epithelial cells and clumps of ductal epithelial cells from within a breast duct. The ductal access device also comprises an elongated access catheter having a distal end, one lumen and dimensions which permit introduction of the distal end through a ductal orifice so that a distal end of the catheter may be positioned distal to the ductal sphincter of a human breast. The medical instrument may also include at least one spacing member for adjustably positioning the manifold hub a desired distance above the surface of the nipple. The spacing member may control the insertion depth of the catheter into the duct. The medical instrument may also include at least one member for anchoring the device to the breast.

Abstract: An emboli filter for deployment in a body lumen to capture emboli entrained in a fluid flowing through the lumen includes a flexible elongated member sized to be passed through the lumen. A filter media is carried on and substantially surrounding the elongated member. The filter media has a first end secured to the elongated member adjacent the distal end. A second end of the filter media has a periphery movable toward and away from the elongated member. Opposing internal surfaces of the filter media define a volume into which emboli may flow through the second end when the periphery is moved away from the elongated member. The emboli are trapped within the volume when the periphery is moved toward the elongated member. An actuator moves the periphery toward and way from the elongated member. The actuator includes a plurality of elastic loops. The loops are biased to an open loop configuration with the loops urging the periphery away from the elongated member.

Abstract: An emboli filter for deployment in a body lumen to capture emboli entrained in a fluid flowing through the lumen includes a flexible elongated member sized to be passed through the lumen. A filter media is carried on and substantially surrounding the elongated member. The filter media has a first end secured to the elongated member adjacent the distal end. A second end of the filter media has a periphery movable toward and away from the elongated member. Opposing internal surfaces of the filter media define a volume into which emboli may flow through the second end when the periphery is moved away from the elongated member. The emboli are trapped within the volume when the periphery is moved toward the elongated member. An actuator moves the periphery toward and way from the elongated member. The actuator includes a plurality of elastic loops. The loops are biased to an open loop configuration with the loops urging the periphery away from the elongated member.

Abstract: An emboli filter for deployment in a body lumen to capture emboli entrained in a fluid flowing through the lumen includes a flexible elongated member sized to be passed through the lumen. A filter media is carried on and substantially surrounding the elongated member. The filter media has a first end secured to the elongated member adjacent the distal end. A second end of the filter media has a periphery movable toward and away from the elongated member. Opposing internal surfaces of the filter media define a volume into which emboli may flow through the second end when the periphery is moved away from the elongated member. The emboli are trapped within the volume when the periphery is moved toward the elongated member. An actuator moves the periphery toward and way from the elongated member. The actuator includes a plurality of elastic loops. The loops are biased to an open loop configuration with the loops urging the periphery away from the elongated member.