Pap smear T-zone sampler

Claim 2

A sampling instrument for collecting cells exfoliated from the uterine cervix of a woman and having a horizontally elongated aspirator tube with respective proximate and distal ends, the distal end portion of the tube being insertable into the aperture of the cervix and having a portion flattened to form a lateral lobe projecting downward transversely of the length of the tube for engagement against the vaginal ring of the cervix, the tube having a through bore enabling mucus in the endocervical canal to be sucked into such bore, characterized by the flattened portion of the distal end portion of the tube forming a scraper having the combination of: a flattened frontal lobe including a blunt-nosed, convexly rounded distal tip portion insertable into the aperture of the cervix, the tube bore opening substantially at the periphery of said blunt-nosed, convexly rounded distal tip portion, and said frontal lobe projecting forward from the lateral lobe a distance sufficient to position said bore opening at approximately the external os when the lateral lobe is in engagement with the vaginal ring of the cervix; a concave transition section disposed between and joining the upper portion of the lateral lobe and the proximate portion of said frontal lobe; a blunt scraping edge engageable with the inner margin of the vaginal ring of the cervix and positioned to extend across the area of the transformation zone when the lateral lobe is engaged against the vaginal ring of the cervix, said blunt scraping edge forming the distal edge of the lateral lobe, the outer edge of said transition section and the bottom edge of said frontal lobe; and at least one substantially planar upright lateral side offset from the tube bore and forming with said scraping edge an angular junction enabling collection of a scraping sample of exfoliated cells from the transformation zone while the distal tip portion of the tube is inserted for collection of an aspiration sample.

Claim 3

An instrument as claimed in claim 1, in which the radius of curvature of the periphery of the distal tip portion of the frontal lobe is at least as great as the diameter of the bore opening such that the upright height of the frontal lobe is at least twice the diameter of the bore opening.

Claim 4

An instrument as claimed in claim 1, in which the blunt-nosed, convexly rounded distal tip portion of the frontal lobe is substantially semicircular in profile and the tube bore opens substantially centrally of the blunt-nosed distal tip portion of the frontal lobe.

Claim 5

An instrument as claimed in claim 1, in which the periphery of the distal tip portion of the frontal lobe extends generally radially from the bore opening substantial distances in opposite directions for forming the blunt-nosed distal tip portion.

Claim 6

An instrument as claimed in claim 1, in which the minimum horizontal thickness of the scraper in a direction laterally of the tube bore is at least as great as the diameter of the bore opening.

Claim 7

An instrument as claimed in claim 1, in which the scraper has a second longitudinally extending scraping edge forming an upper edge portion of the scraper for scraping a sample from a lateral wall of the vagina.

Claim 8

An instrument as claimed in claim 6, in which the junction between the substantially planar lateral side of the scraper and the second scraping edge is sharper than the junction between such lateral side and the primary scraping edge.

Claim 9

An instrument as claimed in claim 1, in which the primary scraping edge includes a forward projecting portion extending distally longitudinally of the tube bore a substantial distance and forming the bottom edge of the frontal lobe, and the substantially planar upright side of the scraper includes a marginal portion adjacent to said forward projecting portion of the primary scraping edge and forming therewith a substantially angular junction facilitating scraping of exfoliated cells.

Claim 10

A sampling instrument for collecting cells exfoliated from the uterine cervix of a woman and having a horizontally elongated aspirator tube with respective proximate and distal ends, the distal end portion of the tube being insertable into the aperture of the cervix and having a portion flattened to form a lateral lobe projecting downward transversely of the length of the tube for engagement against the vaginal ring of the cervix, the tube having a through bore enabling mucus in the endocervical canal to be sucked into such bore, characterized by the flattened portion of the distal end portion of the tube forming a scraper having the combination of: a frontal lobe insertable into the aperture of the cervix, said frontal lobe projecting forward from the lateral lobe a distance sufficient to position said bore opening at approximately the external os when the lateral lobe is in engagement with the vaginal ring of the cervix; a concave transition section disposed between and joining the upper portion of the lateral lobe and the proximate portion of said frontal lobe; a blunt scraping edge engageable with the inner margin of the vaginal ring of the cervix and including a forward projecting portion extending distally generally longitudinally of the tube a substantial distance, said scraping edge being positioned to extend across the area of the transformation zone when the lateral lobe is engaged against the vaginal ring of the cervix and forming the distal edge of the lateral lobe, the outer edge of said transition section and the bottom edge of said frontal lobe; and at least one substantially planar upright lateral side offset from the tube bore, extending along the entire length of said scraping edge and forming therewith an abrupt junction enabling collection of exfoliated cells from the transformation zone while the distal tip portion of the tube is inserted for collection of an aspiration sample.

Claim 11

A sampling instrument for collecting cells exfoliated from the uterine cervix of a woman and having a horizontally elongated aspirator tube with respective proximate and distal ends, the distal end portion of the tube being insertable into the aperture of the cervix and having a portion flattened to form a lateral lobe projecting downward transversely of the length of the tube for engagement against the vaginal ring of the cervix, the tube having a through bore enabling mucus in the endocervical canal to be sucked into such bore, characterized by the flattened portion of the distal end portion of the tube forming a scraper having the combination of: a frontal lobe insertable into the aperture of the cervix, said frontal lobe projecting forward from the lateral lobe a distance sufficient to position said bore opening at approximately the external os when the lateral lobe is in engagement with the vaginal ring of the cervix; a concave transition section disposed between and joining the upper portion of the lateral lobe and the proximate portion of said frontal lobe; a blunt scraping edge engageable with the inner margin of the vaginal ring of the cervix and including a forward projecting portion extending distally generally longitudinally of the tube a substantial distance, said scraping edge being positioned to extend across the area of the transformation zone when the lateral lobe is engaged against the vaginal ring of the cervix and forming the distal edge of the lateral lobe, the outer edge of said transition section and the bottom edge of said frontal lobe; and at least one substantially planar upright lateral side offset from the tube bore, extending along the entire length of said scraping edge and forming therewith an abrupt junction enabling collection of exfoliated cells from the transformation zone while the distal tip portion of the tube is inserted for collection of an aspiration sample.

Claim 12

An instrument as claimed in claim 9, in which the tube is substantially rigid molded plastic material and the scraper is tapered downward in the direction of projection of the lateral lobe, the scraper decreasing in horizontal thickness from the tube bore toward the tip of the lateral lobe.

Claim 13

An instrument as claimed in claim 9, in which the junction between the primary scraping edge of the scraper and the substantially planar lateral side of the scraper is slightly rounded.

Claim 14

An instrument as claimed in claim 11, in which the radius of curvature of the junction between the primary scraping edge of the scraper and the substantially planar lateral side of the scraper is between about 0.01 inch (0.25 mm) and about 0.03 inch (0.76 mm).

Claim 15

An instrument as claimed in claim 9, in which the scraper includes a substantially semi-cylindrical side located opposite the substantially planar side.

Claim 16

An instrument as claimed in claim 9, in which the scraper has a substantially cylindrical distal tip portion and a scraping angular corner projection projecting laterally from said substantially cylindrical tip portion and forming the angular junction between the distal portion of the blunt scraping edge and the substantially planar side of the scraper, such blunt scraping edge extending from said tip portion substantially parallel to the length of the tube a substantial distance toward the proximate end of the tube.

Claim 17

An instrument as claimed in claim 9, in which the tube is substantially rigid molded plastic material and the scraper is tapered in direction of projection of the lateral lobe.

Claim 18

An instrument as claimed in claim 15, in which the lateral lobe is tapered in a direction generally parallel to the tube bore toward the distal end of the tube.

Claim 19

A sampling instrument for collecting cells exfoliated from the uterine cervix of a woman and having a longitudinally elongated aspirator tube with respective proximate and distal ends, the tube having a through bore enabling mucus in the endocervical canal to be sucked into such bore, the distal end portion of the tube forming a scraper and having a distal tip portion insertable into the aperture of the cervix, a lateral lobe projecting transversely of the length of the tube for engagement against the vaginal ring of the cervix, the tube bore opening substantially at the extremity of said distal tip portion, a concave transition section disposed between and joining the inner portion of the lateral lobe and the proximate portion of said distal tip portion, and a blunt scraping edge forming the distal edge of the lateral lobe and the outer edge of said transition section, the lateral lobe having at least one substantially planar lateral side offset from the tube bore and forming with said scraping edge an angular junction, characterized in that the distal tip portion is a flattened frontal lobe including a blunt-nosed, convexly rounded distal tip, the frontal lobe forming part of a flattened portion of the distal end portion of the tube, which flattened portion also forms the lateral lobe, the frontal lobe projecting forward from the lateral lobe a distance sufficient to position said bore opening at approximately the external os when the lateral lobe is in engagement with the vaginal ring of the cervix, the scraping edge also forming a lateral edge of the frontal lobe, and in that the scraping edge is engageable with the inner margin of the vaginal ring of the cervix and positioned to extend across the area of the transformation zone when the lateral lobe is engaged against the vaginal ring of the cervix, so as to enable collection of a scraping sample of exfoliated cells from the transformation zone while the distal tip portion of the tube is inserted for collection of an aspiration sample.

Claim 20

A sampling instrument for collecting cells exfoliated from the uterine cervix of a woman and having a longitudinally elongated aspirator tube with respective proximate and distal ends, the tube having a through bore enabling mucus in the endocervical canal to be sucked into such bore, the distal end portion of the tube forming a scraper and having a distal tip portion insertable into the aperture of the cervix, a lateral lobe projecting transversely of the length of the tube for engagement against the vaginal ring of the cervix, the tube bore opening substantially at the extremity of said distal tip portion, a concave transition section disposed between and joining the inner portion of the lateral lobe and the proximate portion of said distal tip portion, and a blunt scraping edge forming the distal edge of the lateral lobe and the outer edge of said transition section, the lateral lobe having at least one substantially planar lateral side offset from the tube bore and forming with said scraping edge an angular junction, characterized in that the distal tip portion is a flattened frontal lobe including a blunt-nosed, convexly rounded distal tip, the frontal lobe forming part of a flattened portion of the distal end portion of the tube, which flattened portion also forms the lateral lobe, the frontal lobe projecting forward from the lateral lobe a distance sufficient to position said bore opening at approximately the external os when the lateral lobe is in engagement with the vaginal ring of the cervix, the scraping edge also forming a lateral edge of the frontal lobe, and in that the scraping edge is engageable with the inner margin of the vaginal ring of the cervix and positioned to extend across the area of the transformation zone when the lateral lobe is engaged against the vaginal ring of the cervix, so as to enable collection of a scraping sample of exfoliated cells from the transformation zone while the distal tip portion of the tube is inserted for collection of an aspiration sample.