METHODS AND DEVICES FOR CERVICAL CELL AND TISSUE SAMPLING
The present invention comprises methods and devices comprising a cutting element used to contact circumferentially and longitudinally the surface walls of the endocervical canal to provide for broad and complete contact of the intended surface with the device, resulting in attainment of a sufficient volume and comprehensive tissue sample for analysis as an endocervical curettage or screening pap smear. The device may provide for a reservoir for the obtained sample to be contained when removing from the cervical canal and vagina. The device may be comprised of a detachable means or be of a material that allows the user to cut the sampling head of the device for placement in collection means to maximize the amount of tissue or cells being sent to the laboratory for analysis.
1 .- 20 . (canceled)
21 . A method of diagnosing cervical lesions, comprising:
a) diagnosing the presence or absence of one or more cervical lesions of a female animal based on tissue and cells in a sample obtained by a cervical sampling device comprising,
i) a handle having a distal end and a longitudinal axis:
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 that defines a conical tip having a proximal and a distal end, and a back end, and wherein the back end is fixedly mounted to the distal end of the handle;
iii) a selectively moveable actuator coupled to the distal end of the handle and to a proximal end of a sheath;
iv) a selectively moveable actuator coupled to the handle and to a proximal end of the sheath, wherein the sheath encapsulates a portion of the wand and is fixedly mounted to the proximal end of the conical tip, and to a portion of the actuator, wherein the sheath defines a helical slit that is located in a distal end portion of the sheath, and is selectively movable between a closed position, in which opposing edges of the slit adjoin, and an open position, in which the opposing edges of the slit are spaced apart, and wherein the actuator is selectively movable between a first position, in which the helical slit is positioned in the closed position, and a second position, in which the helical slit is positioned in the open position,
wherein the distal end portion of the sheath and a portion of the exterior surface of the wand underlying the distal end portion of the sheath define a sample collection cavity.
22 . The method of claim 21 , wherein the conical tip defines an atraumatic tip.
23 . The method of claim 21 , wherein the sample collection cavity has a volume of from 0.02 mL to 1.2 mL.
24 . A medical device for sampling cervical tissue, comprising,
i) a handle having a distal end and a longitudinal axis:
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 that defines a conical tip having a proximal and a distal end, and a back end, and wherein the back end is fixedly mounted to the distal end of the handle;
iii) a selectively moveable actuator coupled to the distal end of the handle and to a proximal end of a sheath;
iv) a selectively moveable actuator coupled to the handle and to a proximal end of the sheath, wherein the sheath encapsulates a portion of the wand and is fixedly mounted to the proximal end of the conical tip, and to a portion of the actuator, wherein the sheath defines a helical slit that is located in a distal end portion of the sheath, and is selectively movable between a closed position, in which opposing edges of the slit adjoin, and an open position, in which the opposing edges of the slit are spaced apart, and wherein the actuator is selectively movable between a first position, in which the helical slit is positioned in the closed position, and a second position, in which the helical slit is positioned in the open position,
wherein the distal end portion of the sheath and a portion of the exterior surface of the wand underlying the distal end portion of the sheath define a sample collection cavity.
25 . The device of claim 24 , wherein the conical tip defines an atraumatic tip.
26 . The device of claim 24 , wherein the sample collection cavity has a volume of from 0.02 mL to 1.2 mL.
27 . A method of monitoring the status of an endocervical canal of a female animal post-surgery, comprising:
determining status of tissue and/or cells based on a sample from an endocervical canal of a female animal collected at a time after surgery of the endocervical canal that was obtained by a cervical sampling device comprising,
a) an elongate wand extending distally from, and along a longitudinal axis of, a handle having a distal end, wherein the elongate wand has an exterior surface, a front end that defines a conical tip having a proximal and a distal end, and a back end, and wherein the back end is fixedly mounted to the distal end of the handle;
b) a selectively moveable actuator coupled to the distal end of the handle and to a proximal end of a sheath;
wherein the sheath encapsulates a portion of the elongate wand and is fixedly mounted to the proximal end of the conical tip, and to a portion of the selectively moveable actuator, wherein the sheath defines a helical slit in a distal end portion of the sheath that is selectively movable between a closed position, in which opposing edges of the helical slit substantially adjoin, and an open position, in which the opposing edges of the helical slit are spaced apart, and wherein the selectively moveable actuator is selectively movable between a first position, in which the helical slit is positioned in the closed position, and a second position, in which the helical slit is positioned in the open position, wherein the distal end portion of the sheath and a portion of the exterior surface of the elongate wand underlying the distal end portion of the sheath define a sample collection cavity.
28 . The method of claim 27 , wherein the conical tip defines an atraumatic tip.
29 . The method of claim 27 , wherein the sample collection cavity has a volume of from 0.02 mL to 1.2 mL.
30 . The method of claim 26 , wherein the sample obtained has no contamination by ectocervical cells.