Methods and compositions for endometrial cell and tissue sampling

A method of diagnosis of uterine disease, comprising:

• a) collecting a uterine cellular sample by introducing and advancing to a desired location in an uterine cavity of a subject a distal end portion of a sheath member of an endometrial sampling apparatus comprising:
• i) a handle comprising a distal end and a longitudinal axis, the handle comprising suction components;
• ii) an elongate wand extending outwardly from the distal end of the handle along the longitudinal axis, wherein the wand has an exterior surface, a front end and a back end, and wherein the back end is fixedly mounted to the distal end of a first portion of the handle;
• iii) a selectively moveable actuator member coupled to a second portion of the handle and to a sheath;
• iv) a sheath member selectively encapsulating a portion of the wand and fixedly mounted to the wand proximate the front end of the wand and to the first end of the actuator member, wherein the sheath member defines at least one slit on a distal end portion of the sheath member, the at least one slit being bordered by opposing edges;
• wherein the distal end portion of the sheath member and the exterior surface of the wand underlying the distal end portion of the sheath member define a sample collection cavity;
• b) rotating the selectively moveable actuator to a position to selectively extend the at least one slit to an open position to form a tissue sampling element;
• c) selectively urging the tissue sampling element against tissue at the desired location in the uterine cavity while rotating the second portion of the handle of the endometrial sampling apparatus to affect corresponding rotation of the open positioned at least one slit to collect a cellular sample into the sample collection cavity, and optionally, providing suction to assist collection of the cellular sample;
• d) rotating the selectively moveable actuator member to selectively move the at least one slit to a closed position to selectively close the sample collection cavity;
• e) withdrawing the endometrial sampling apparatus from the subject;
• and
• f) determining whether uterine disease is present.