Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0291—Instruments for taking cell samples or for biopsy for uterus

Definitions

• My invention relates to a cytological sampling instrument for collecting cells exfoliated from the uterine cervix.
• the vagina 1 is distended by a speculum 2 enabling the portio vaginalis (vaginal portion) 11 of the cervix to be viewed, and a paddle-like scraper 3 is used to collect exfoliated cells from the posterior fornix 4 of the vagina, that is, from the "vaginal pool".
• This is the area selected for sampling by Papanicolaou because cells exfoliated from virtually all areas of the cervix and from the uterus gather in the vaginal pool, though
• vaginal pool smears are quickly, easily and inexpensively taken, they still are used to a large extent, particularly when funds for screening a large population are limited.
• Ayre invented the specially designed scraper 7 shown in Figure 2 to be used for scraping the entire circumferential extent of the T-zone for early detection of cell abnormalities.
• the Ayre scraper has two lobes including a frontal lobe 8 insertable slightly into the endocervical canal 9 and an adjacent lateral lobe 10 abuttable against the vaginal portion or ring 11 of the cervix. In this position the concave portion 12 of the scraper edge joining the two lobes is in engagement with the T-zone.
• the frontal lobe 8 acts as a pivot as the scraper is rotated for scraping of the entire circumferential extent of the T-zone.
• Ayre himself, recognized that a more reliable diagnosis could be obtained if the scraping sample was not the only sample obtained from a patient. He pro ⁇ posed that at least two separate sampling operations be performed —one using his scraper and another using a separate instrument for obtaining an additional sample directly from the endocervical canal. In fact, research has shown that relying solely on a sample obtained by use of an Ayre scraper can result in a false negative rate of as high as about 30%.
• FIGS. 3 and 4 Methods for obtaining samples directly from the endocervical canal are shown in Figures 3 and 4.
• the narrow forward end of a pipette 13 is inserted into the endocervical canal.
• the tip of the pipette is positioned at about the external os, but it is difficult to position the pipette precisely so that sometimes the tip of the pipette is inserted almost up to the internal os 14 as shown in Figure 3.
• Suction is applied drawing mucus containing exfoliated cells into the lumen of the pipette. Published research suggests that carefully performed external os aspiration gives more reliable results than any other known single method.
• the soft tip 15 of a saline-moistened cotton-tipped applicator 16 is inserted into the endocervical canal and rotated and moved in and out. While less traumatic than the method of Figure 3 , there still is a substantial chance of endocervical mucosal injury and bleeding. Also, cells valuable for diagnostic purposes adhere in the inter ⁇ stices of the cotton fiber. Further, it is difficult to transfer the sample to a slide, and vigorously rubbing the cotton-tipped applicator on the slide distorts the cells making them difficult to evaluate.
• Adherence of and damage to cells also is a problem with the methods of Figures 1 and 2 because most scrapers presently used are manufactured from thin strips of wood and cells become trapped in the pores and cracks in the wood. There also is a possibility of abrading the cervix with the irregular edge of a wood scraper.
• Slides received at a laboratory show signifi ⁇ cant variation, illustrating a wide range of sampling techniques and methods of transfering collected cell- containing material to a slide.
• Individual slides may have a single large blop, multiple streaks, globs or a small spot of material such that it is difficult to examine individual cells, making examination time consuming and sometimes inaccurate.
• the patient must be scheduled for an additional smear sample to be taken which, in effect, doubles the inconvenience to the patient, the work of the doctor or paramedic and the consequent expense. Also, the patient may be distressed from having been asked to return for an additional smear, regardless of the reassurances that she receives from the physician that an abnormality is unlikely.
• the Kohl instrument is intended to be gripped at an annular flange projecting from the proximate end portion of the instrument, which may make the Kohl instrument difficult to manipulate; as with other known aspiration pipettes, it may be difficult to position the pipette precisely and, during insertion, the sharp narrow forward end may lacerate or puncture the friable endocervical epi ⁇ thelium, causing bleeding; once the instrument is inserted, substantial dexterity would be required to hold the forward end portion of the instrument substantially stationary while the plunger is retracted to draw mucus into the lumen of the instrument; if the forward end portion of the instrument is not maintained stationary, in-and-out movement of the sharp tip of the pipette may cause bleeding ; the small plunger may not be able to generate sufficient suction to draw viscous cell-containing mucus into the lumen of the tube; diagnostically valuable cells may be trapped in the corrugations of the flexible joint; the concave scraping edge of the Kohl instru ⁇ ment is
• Shute in his United States patent No. 3,088,454 disclosed another type of cervical sampling instrument having a scraper and an aspirator tube. Unlike applicant's instrument, the Shute device is designed to obtain the aspiration sample from the internal os, and as the Shute device is rotated, sub ⁇ stantially the entire lengthwise extent of the endo- cervical canal is scraped by a serrated edge which may cause bleeding.
• Robinson in his United States patent No. 4,043,322 disclosed an aspiration instrument having a forward projecting, sharp-edged blade for obtaining tissue samples from the walls of a uterus.
• Crane et al. in their United States patent No. 4,078,656 disclosed a return mailer type package for an Ayre scraper, a cotton-tipped applicator, a slide and an ampule of fixative.
• I provide an aspirator tube having a flattened distal end portion forming a spatulate scraper including a frontal lobe through which the bore of the tube opens and an adjacent lateral lobe abuttable against the vaginal ring of the cervix for positioning the apertured tip of the frontal lobe approximately at the external os.
• a concave transition section of the scraping edge of the spatulate scraper between the two lobes is shaped substantially complementally to the inner margin of the vaginal ring of the cervix for engagement with the transformation zone.
• suction is applied to the proximate end portion of the tube for drawing cell- containing mucus into the tube, followed by rotation of the tube for scraping the entire circumferential extent of the T-zone.
• the aspiration sample is pooled onto a slide and the scraping sample deposited in the pool, whereupon the combined sample is spread thinly and evenly as a monolayer of cells on the slide surface.
• Figure 5 is a top perspective of a Pap smear T-zone sampler in accordance with the present invention
• Figure.6 is a top perspective of a kit includ ing the sampler of - Figure 5, a cotton-tipped applicator, a glass slide, a protective slide case and a package for those components, as well as alternative suction- generating devices for use with the sampler,
• Figure 7 is a fragmentary side elevation of the distal end portion of the sampler of Figure 5,
• Figure 8 is an end elevation of the sampler of Figure 5
• Figures 9 and 10 are corresponding, somewhat diagrammatic, generally axial sections of a vaginal cavity illustrating a sampler in accordance with the present invention being used for collecting a sample of cell-containing material, with parts broken away, and Figures 11, 12, 13 and 14 are corresponding, fragmen ⁇ tary, somewhat diagrammatic, top perspectives illustrat ⁇ ing the sample being deposited on a glass slide and fixed, and
• Figure 15 is a somewhat diagrammatic, general ⁇ ly axial section through a vaginal cavity illustrating an alternative manner of collecting a sample by use of the Pap smear T-zone sampler of Figure 5, with parts broken away.
• lobe means a blunt nosed projection that is at least somewhat flattened in that it has at least one substantially flat side face.
• the Pap smear T-zone sampler of the present invention is an elongated aspira ⁇ tor tube 20 having a substantially linear axial through bore 21.
• the distal end portion 22 of the tube is flattened forming a spatulate scraper.
• such scraper is shaped substantially the same as an Ayre scraper in having a forward projecting or frontal lobe 23 and an adjacent generally radially projecting or lateral lobe 24.
• a concave transition section 25 of the scraping edge of the scraper is faired into the adjacent edges of the two lobes. All corners forming junctions between the sides and edges of the scraper are rounded.
• a circumferential rib 26 divides the long barrel of the tube into a cylindrical stem 27 carrying the spatulate scraper and a long straight handle portion
• Such handle portion is of hexagonal cross section, forming longitudinally extending grip-promoting ridges
• the relatively short proximate end portion 30 of " the tube is cylindrical.
• the bore 21 of the tube opens at about the center of the blunt rounded tip of the scraper frontal lobe 23. Throughout the length of the scraper portion 22, such bore is of uniform, but small, diameter. Proceeding toward the proximate end of the tube, the diameter of the bore increases abruptly forming an annular step 31. Throughout the length of the barrel of the tube, the diameter of the bore is uniform, but large in comparison to the diameter of the distal portion of the bore extending through the spatulate scraper.
• the aspirator tube be injection molded from plastic material. Also it is preferred that both sides of the flattened spatulate scraper be planar. However, injection molded plastic material has a tendency to shrink in the center of a large thick area forming a characteristic depression or "dish". By tapering the spatulate scraper from top to bottom, that is, by gradually and uniformly decreasing the thickness of the scraper outward toward the tip of the lateral lobe, as shown in Figure 8, shrinking of the plastic material at the center of the lateral lobe is less of a problem and both sides of the scraper will be substantially planar rather than having substantial central depressions.
• planar side faces of the scraper are slightly hydrophilic, which can be achieved by adding a hydrophilic substance to the plastic mate ⁇ rial from which the scraper is formed or, as shown in the drawings, by texturing such sides by molding short criss-crossed ribs 32 integrally in the sides of the scraper as best seen in Figure 5.
• both an external os endocervical aspiration sample and a T-zone scraping sample can be obtained.
• the sampler is inserted lengthwise into the vagina 1 distended by a conventional speculum 2 and the broad rounded tip of the frontal lobe 23 is substantial ⁇ ly self-centering in the endocervical canal 9 without fear of lacerating or puncturing the cervix.
• the leading edge of the scraper lateral lobe 24 is located for engagement with the vaginal ring 11 of the cervix to position the apertured tip of the frontal lobe slightly inward of the external os 6.
• the scraping edge of the scraper formed by the concave transition section 25 and the adjacent edges of the two lobes, is in engagement with the T-zone 5.
• Suction is applied to the tube at its proxi ⁇ mate end portion, such as by use of a rubber squeeze bulb 33 having its apertured tip 34 snugly fitted over the cylindrical proximate end portion 29 of the tube in sealing engagement.
• a rubber squeeze bulb 33 having its apertured tip 34 snugly fitted over the cylindrical proximate end portion 29 of the tube in sealing engagement.
• the flared, distal, lumen-forming end portion of a conventional syringe such as the syringe 35 shown in Figure 7, can be fitted inside the bore of the cylindrical proximate end portion of the tube so that the syringe can be used as a suction-generating device.
• the suction is concentrated in the endocervical canal because the distal end portion of the tube bore is of small diameter. Even viscous cell-containing mucus will be drawn into the tube.
• the suction-generating device is reusable and, accordingly, it is preferred that no mucus be drawn into the suction-generating device, which could contaminate future samples. Since, in the barrel of the tube, the tube bore is of large diameter, a substantial amount of mucus can be drawn into the tube without entering the suction-generating device. In addition, the abrupt step 31 of the bore causes a turbulent flow tending to retain the mucus in the distal end portion of the tube bore, as opposed to a laminar flow which could result in mucus flowing hori ⁇ zontally into the suction-generating device.
• the tube is rotated at least one full turn as the scraping edge of the spatulate scraper is held gently against the vaginal ring of the cervix.
• the entire circumferential extent of the T-zone is scraped for collecting freshly exfoliated cells.
• the scraping sample adheres to the leading side of the scraper because the sides of the scraper are textured or slightly hydrophilic.
• An alternative to the two sequential sample- collecting steps described above is to obtain the aspiration sample as the scraper is being rotated, in which case cell-containing material accumulating at the rotating leading side of the scraper may be drawn into the tube bore with mucus from the endocervical canal.
• Another alternative is to rotate the tube for obtaining the scraping sample first, followed by withdrawing the tube slightly and then applying suction for obtaining the aspiration sample so that exfoliated cells from the T-zone that did not adhere to the leading side of the scraper will be drawn into the tube bore.
• the aspirated sample and the scraped sample are deposited on a glass slide 36 and fixed, as shown in Figures 11 through 14.
• first the aspiration sample is pooled onto the slide immediately adjacent to its frosted end 37.
• the scraped sample is transferred to the slide by gently rubbing the leading side of the scraper in the pool as illustrated in Figure 12.
• the combined sample is spread substantially uniformly and thinly on the upper surface slide, as illustrated in Figure 13, by butting the circumferential rib 26 of the tube against a longitudinal edge of the slide with the cylindrical sample-spreading stem 27 resting flatly on the upper surface of the slide and moving the tube lengthwise of the slide away from its frosted end. -Cmmediately following spreading of the sample, the
• C sample is fixed, such as by use of a conventional spray-type fixative as illustrated in Figure 14.
• the entire sample transferring and fixing operation can be performed in a matter of a few seconds so that there will be no appreciable air drying of either sample.
• Each slide should have a thin monolayer of well preserved cells, making microscopic examination and diagnosis quick and reliable.
• the shaft 38 of a cotton-tipped applicator 16 can be inserted into the narrow distal end portion of the bore 21 of the tube 20 up to the soft tip 15 of the applicator.
• the diameter of the tube bore is only slightly greater than the diameter of the shaft so that the cotton- tipped applicator is received in the tube bore in snug engagement for firmly connecting the applicator to the aspirator tube.
• the aspirator tube still is sub ⁇ stantially self-centering as it is inserted lengthwise into the vagina 1 for inserting the tip. of the cotton- tipped applicator into the endocervical canal 9.
• the scraping edge of the flattened spatulate scraper portion 22 of the tube is in engage ⁇ ment with the T-zone 5.
• the tube is rotated for obtaining a T-zone scraping sample, simultaneously exfoliated cells in the endocervical canal are collected on the tip of the cotton-tipped applicator.
• the tube is withdrawn and, quickly, the cotton-tipped applicator and the leading side of the scraper are rubbed gently against a glass slide for transferring cellular material to the slide.
• the combined samples are fixed immediately.
• the present invention also can be used for obtaining a sample for hormonal evaluation, which sample preferably is obtained from the proximal third of the lateral vaginal wall.
• a sample for hormonal evaluation which sample preferably is obtained from the proximal third of the lateral vaginal wall.
• the top edge of the scraper opposite its lateral lobe can be rubbed gently against the lateral vaginal wall between the blades of the speculum.
• This sample from the lateral vaginal wall can be deposited on a separate slide or at one end portion of the slide containing the cervical scrape sample.
• the present invention is provided in a kit including: the
• Pap smear T-zone sampler 20 of the present invention which usually will be used to obtain an external os aspiration sample and T-zone scraping sample as shown in Figures 9 and 10; a long shafted cotton-tipped applicator 16, which can be used for wiping away excess mucus from the vaginal portion of the cervix or which can have its shaft shortened for insertion into the bore of the sampler as illustrated in Figure 15; a slide 36 for receiving a sample taken by use of the sampler of the present invention; a rigid slide case 39 for protecting the slide in transit to a medical labo ⁇ ratory; and a folding cardboard package 40 which may be of the return mailer type.
• a suction-generating device either a 30 cc rubber squeeze bulb 33 or a 10 cc plastic syringe 35 can be provided separately. Similar ⁇ ly, spray fixative is preferred and also can be provide separately.
• the diameter of the narrow distal end portion of the tube bore should be no greater than about 1/8 inch (.32 cm). As discussed above, preferably the diameter of the narrow portion of the bore is substantially the same as the diameter of the shaft of a cotton-tipped applicator which, for applicators currently available, is about 3/32 inch (.24 cm).
• the diameter of the larger prox- . imate end portion of the bore should be at least about 1-1/2 times, preferably about 2 times, the diameter of the narrow distal end portion of the bore for creating the abrupt step between the two bore portions and for storing a substantial quantity of mucus.
• the transverse thickness of the spatulate scraper should be small, preferably no greater than about twice the diameter of the narrow portion of the tube bore, because there is less chance of a "dish” resulting in a thin section of injection molded plastic material than in a thicker section. Nevertheless, the scraper must be thick enough that the lateral walls of the tube bore will not break or bend appreciably during use of the instrument.
• the scraper is tapered uniformly from its thickest top portion, which is about 3/16 inch (.48 cm) thick, to its thinnest bottom portion, which is about 3/32 inch (.24 cm) thick, as shown in Figure 8.
• the frontal lobe should be broad in comparison to the diameter of the narrow portion of the tube bore to eliminate the possibility of perforating the cervix.
• the breadth of such lobe that is, the upright dimension as shown in Figure 7, is at least twice the diameter of the narrow portion of the tube bore, in the preferred embodiment about 1/4 inch (.64 cm) which is between 2 and 3 times the preferred bore diameter.
• the tip of the frontal lobe should be blunt and rounded, having a radius of curvature at least equal to about the diameter of the narrow portion of the tube bore.
• the tip of the frontal lobe is substantiall semicircular, the radius of curvature being about 1/8 inch (.32 cm) .
• leading edge of the lateral lobe must project outward a distance sufficient for engagement with the vaginal ring of the cervix and in the preferre embodiment such lobe projects outward about 7/16 inch (1.1 cm) from the axis of the tube bore.
• leading edge must be located rearward from the apertured tip of the frontal lobe a distance such that the apertured tip of the frontal lobe is in close proximity to the external os when the leading edge of the lateral lobe is in engagement with the vaginal ring of the cervix.
• the leadin edge of the lateral lobe is located about 1/4 inch (.64 cm) rearward of the tip of the frontal lobe.
• the corners forming junctions between the scraper lateral side faces and the T-zone scraping edge which includes the adjacent edges of the frontal and lateral lobes and the concave transition section between the lobes, must be rounded sufficiently as to prevent abrading the cervix yet should not be so rounde as to prevent a good scraping effect for collecting exfoliated cells.
• the radius of curvature of each of such corners is about .01 inch (.25 mm), and should be no greater than about .03 inch (.76 mm).
• the top edge of the scraper which may be used to obtain a sample from the lateral vaginal wall, can have somewhat sharper longitudinally extending corners because the vaginal wall is less friable and prone to bleeding than the cervix.
• the radius of curvature of each upper longitudinally extending corner is about .001 inch (.025 mm) or less.
• the outside diameter of the proximate end portion is about 1/4 inch (.64 cm) and such end portion is about 11/32 inch (.87 cm) long.
• the inside dia ⁇ meter of the proximate end portion must be such as to fit over the distal, lumen-forming tip of a conventional 10 cc syringe in snug sealing engagement.
• a diameter of about 5/32 or 3/16 inch (.40 or .48 cm) for the distal end portion of the tube bore meets this requirement.
• the length and diameter of the long straight handle portion of the tube should be sufficient that the tube can be manipulated easily.
• the barrel of the tube is about 6 inches (15 cm) long and the distance between opposite flat sides of the handle portion is slightly greater than 1/4 inch (.64 cm) such that the handle portion is about the same size and is the same shape as a pencil, assuring easy handling of the instrument.
• the sampler can be injection molded from clear polypropylene plastics material, in which case the sampler is sufficiently inexpensive that it can be thrown away after use.

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Citations (11)

• 1981
  • 1981-04-13 EP EP19810901104 patent/EP0050632B1/en not_active Expired
  • 1981-04-13 DE DE8181901104T patent/DE3176198D1/de not_active Expired
  • 1981-04-13 JP JP56501450A patent/JPS57500544A/ja active Pending
  • 1981-04-13 AU AU70783/81A patent/AU544398B2/en not_active Ceased
  • 1981-04-13 WO PCT/US1981/000475 patent/WO1981002974A1/en active IP Right Grant
  • 1981-04-16 CA CA000375724A patent/CA1164761A/en not_active Expired
  • 1981-12-17 FI FI814071A patent/FI69241C/fi not_active IP Right Cessation

Patent Citations (11)

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