Biopsy/cytology device and method for sampling cells or tissue in mammals

A method for detaching cells or tissue from a cavity in a subject, the method comprising:

• providing a device that includes:
• a handle;
• an elongated member extending from the handle and arranged to be moved within a lumen of a needle or a catheter;
• a flexible member arranged at a distal end of the elongated member, wherein the flexible member has a first, constrained configuration within the lumen of the needle or catheter and, following advancement of the elongated member in the needle or catheter, the flexible member has a second, expanded configuration outside said lumen;
• a tubular sheath extending from the handle, arranged outside the elongated member and configured to be moved along the elongated member inside the lumen of the needle or catheter;
• a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member;
• a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member;
• and
• a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath;
• introducing the device into the cavity in the subject through the lumen of a hollow needle;
• manipulating the first actuator to advance the elongated member through the lumen of the needle in a distal direction such that the flexible member protrudes from a distal tip of the needle and assumes the second, expanded configuration inside the cavity and comes into contact with an inner wall of the cavity;
• manipulating the third actuator to advance the tubular sheath through the needle such that a distal end of the tubular sheath exits the distal tip of the needle and contacts the expanded flexible member;
• manipulating the second actuator to rotate the elongated member such that the expanded flexible member scrapes the inner wall of the cavity;
• manipulating the first actuator to retract the elongated member into the lumen of the needle such that the flexible member is brought to the first, constrained configuration and re-enters the distal tip of the needle;
• manipulating the third actuator to retract the tubular sheath into the needle;
• aspirating fluid from the cavity through the lumen of the needle;
• and
• retracting the needle from the cavity.