Absorptive tip brush biopsy device, kit and method

A biopsy method, comprising:

• providing a flexible coaxial structure comprising a sheath having a wall and a hollow space inside the wall;
• a displaceable wire within the hollow space, the displaceable wire having a first end configured to extend from a proximal end of the sheath and a second end having a tip covered by a solid cap;
• the second end of the displaceable wire further comprising a cellular sampling structure and an absorptive material adjacent to the solid cap, wherein the cellular sampling structure and the absorptive material are configured to be displaced by a movement of the first end of the displaceable wire between a first position external to the sheath in a first state and a second position internal to the sheath in a second state;
• inserting the distal end of the sheath into an anatomical orifice while the flexible coaxial structure is in the second state;
• pushing the first end of the displaceable wire into the sheath, to cause the flexible coaxial structure to assume the first state with the cellular sampling structure and the absorptive material external to the sheath;
• manipulating the displaceable wire to obtain a cellular sample with the cellular sampling structure rubbing against a tissue surface within the anatomical orifice and the absorptive material absorbing cells and fluid while the solid cap protects the tissue from intrusion by a tip of the displaceable wire;
• applying a tension on the first end of the displaceable wire at the proximal end of the sheath to retract the displaceable wire from the first state to the second state with the cellular sampling structure and the absorptive material within the sheath, while retaining a biopsy sample comprising the absorbed cells and fluid;
• and
• withdrawing the sheath from the anus while preventing contamination of the biopsy sample.

A secure biopsy sample method, comprising:

• inserting a portion of a biopsy sample device into collecting container prefilled with a cytology preservative solution and having an identification device comprising an RFID tag;
• securely closing the sample collecting container to prevent reopening without evidence of tampering;
• and
• utilizing the identification device to maintain a record associated with the cellular sample.