# US 2013/0158429 A1 · Methods and devices for cervical cell and tissue sampling > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158429 A1 - Document ID: US20130158429A1 - Status: Published application - Kind: A1 - Application number: 13/670,322 - Filed: 2012-11-06 - Published: 2013-06-20 - Earliest claimed: 2011-12-15 - Assignees: Femasys Inc. - Inventors: Kathy LEE-SEPSICK; Max S. AZEVEDO; Jeffrey A. MARCUS - Web page: https://patentgrep.com/patent/US20130158429A1 ## CPC - A61B 10/04: Endoscopic instruments, e.g. catheter-type instruments - A61B 5/4331: {of the cervix (A61B5/435 takes precedence)} - A61B 10/0275: {with sample notch, e.g. on the side of inner stylet} - A61B 10/0291: {for uterus (A61B10/0045 takes precedence)} - A61B 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)} - A61B 2017/320733: {with a flexible cutting or scraping element, e.g. with a whip-like distal filament member} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract 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. ## Claims ### Claim 1 A method of obtaining an endocervical sample, comprising: a) providing a cervical sampling apparatus, 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 substantially 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 the handle.; iii. a selectively moveable actuator coupled to the handle and to a sheath; iv. a sheath selectively encapsulating a portion of the wand and fixedly mounted to a portion of the wand proximate the front end of the wand and to a portion of an actuator, 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, wherein the sheath defines at least one slit on a distal end portion of the sheath, the slit being bordered by opposing edges, wherein the slit is selectively movable between a closed position, in which the opposing edges of the helical slit substantially adjoin to substantially seal the sample collection cavity, and an open position, in which the opposing edges of the slit are spaced from each other; and wherein the actuator is selectively movable between a first position, in which the slit is positioned in the closed position, and a second position, in which the helical slit is positioned in the open position; b) introducing and advancing the distal end portion of the sheath to a desired location in the endocervical cavity; c) moving the actuator to the second position to selectively extend the slit to the open position to form the tissue sampling element; d) selectively urging the distal end portion of the sheath comprising the tissue sampling element against tissue at the desired location in the endocervical cavity while simultaneously rotating the handle of the cervical sampling apparatus to affect corresponding rotation of the open positioned slit to collect tissue and cells into the sample collection cavity; e) moving the actuator to the first position to selectively move the slit to the closed position to selectively close the sample collection cavity; and f) withdrawing the cervical sampling apparatus from the subject. ### Claim 2 (depends on 1) The method of claim 1, wherein the step of rotating the handle of the cervical sampling apparatus includes rotating the handle at least one complete revolution in a clockwise or counterclockwise direction. ### Claim 3 (depends on 1) The method of claim 1, wherein the method is performed to obtain cells for diagnosing high grade cervical lesions. ### Claim 4 (depends on 1) The method of claim 1, wherein the method is performed to monitor the post-surgical status of the endocervix and the effectiveness of surgical removal of high-grade cervical lesions. ### Claim 5 (depends on 1) The method of claim 1, wherein the method is performed to diagnose cervical sources of undiagnosed bleeding. ### Claim 6 A cervical sampling apparatus, comprising: a) a handle having a distal end and a longitudinal axis; b) an elongate wand extending outwardly from the distal end of the handle substantially 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 the handle; c) a selectively moveable actuator coupled to the distal end of the handle and to a sheath; d) a sheath selectively encapsulating a portion of the wand and fixedly mounted to a portion of the wand proximate the front end of the wand and to a portion of the first end of the actuator, wherein the sheath defines a slit on a distal end portion of the sheath, the slit being bordered by opposing edges, 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. ### Claim 7 (depends on 6) The apparatus of claim 6, wherein the slit is selectively movable between a closed position, in which the opposing edges of the slit substantially adjoin to substantially seal the sample collection cavity, and an open position, in which the opposing edges of the slit are spaced from each other for obtaining a cervical sample when positioned within an endocervical cavity. ### Claim 8 (depends on 6) The apparatus of claim 6, wherein the actuator is selectively rotatable about the distal end of the handle between a first position, in which the slit is positioned in the closed position, and a second position, in which the slit is positioned in the open position. ### Claim 9 (depends on 6) The apparatus of claim 6, wherein the slit is a helical slit that extends about the longitudinal axis. ### Claim 10 (depends on 6) The apparatus of claim 6, wherein the slit is a longitudinal slit. ### Claim 11 (depends on 6) The apparatus of claim 6, wherein the front end of the wand defines an autramatic tip. ### Claim 12 A cervical sampling apparatus, comprising: a handle having a distal end and a longitudinal axis; an elongate wand extending outwardly from the distal end of the handle substantially 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 the handle; an actuator rotatively coupled to the handle, the actuator defining an opening at a first end that is sized to rotatively receive a portion of the wand a sheath selectively encapsulating a portion of the wand and fixedly mounted to a portion of the wand proximate the front end of the wand and to a portion of the first end of the actuator, wherein the sheath defines a slit on a distal end portion of the sheath, the slit being bordered by opposing edges, wherein the slit is selectively movable between a closed position, in which the opposing edges of the slit substantially adjoin to substantially seal a sample collection cavity, and an open position, in which the opposing edges of the slit are spaced from each other for selectively obtaining a cervical sample when positioned within a vaginal cavity. ### Claim 13 (depends on 12) The apparatus of claim 12, wherein the actuator is selectively rotatable about the distal end of the handle between a first position, in which the slit is positioned in the closed position, and a second position, in which the slit is positioned in the open position. ### Claim 14 (depends on 12) The apparatus of claim 12, 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 the sample collection cavity. ### Claim 15 (depends on 12) The apparatus of claim 12, wherein the slit is a helical slit that extends about the longitudinal axis. ### Claim 16 (depends on 12) The apparatus of claim 12, wherein the actuator defines an interior cavity having an interior peripheral edge having a plurality of spaced female apertures defined thereon, wherein the distal end of the defines a male protrusion extending distally along the longitudinal axis, the male protrusion defining a plurality of radially biasable keys that are configured to be selectively received therein the plurality of spaced female apertures in the respective first and second positions. ### Claim 17 A method of diagnosing endocervical cancer, comprising: a) providing a cervical sampling apparatus to a female subject, 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 substantially 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 the handle; iii. a selectively moveable actuator coupled to the handle and to a sheath; iv. a sheath selectively encapsulating a portion of the wand and fixedly mounted to a portion of the wand proximate the front end of the wand and to a portion of an actuator, 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, wherein the sheath defines at least one slit on a distal end portion of the sheath, the slit being bordered by opposing edges, wherein the slit is selectively movable between a dosed position, in which the opposing edges of the helical slit substantially adjoin to substantially seal the sample collection cavity, and an open position, in which the opposing edges of the slit are spaced from each other; and wherein the actuator is selectively movable between a first position, in which the slit is positioned in the closed position, and a second position, in which the helical slit is positioned in the open position; b) introducing and advancing the distal end portion of the sheath to a desired location in the endocervical cavity of a subject; c) moving the actuator to the second position to selectively extend the slit to the open position; d) selectively urging the distal end portion of the sheath against tissue at the desired location in the endocervical cavity while simultaneously rotating the handle of the cervical sampling apparatus to affect corresponding rotation of the open positioned slit to collect tissue and/or cells into the sample collection cavity; e) moving the actuator to the first position to selectively move the slit to the closed position to selectively close the sample collection cavity; and f) withdrawing the cervical sampling apparatus from the endocervical cavity; g) examining the collected tissue and/or cells for aplastic or abnormal cells, wherein the presence of aplastic or abnormal cells indicates a diagnosis of cancer. ### Claim 18 (depends on 17) The method of claim 17, wherein the step of rotating the handle of the cervical sampling apparatus includes rotating the handle at least one rotation in a clockwise direction and one rotation in a counterclockwise location. ### Claim 19 (depends on 17) The method of claim 17, wherein at least one slit is a helical slit. ### Claim 20 (depends on 17) The method of claim 17, wherein at least one slit is a perpendicular slit.