CERVICAL CYTOLOGY DEVICE

Abstract: A device for simultaneously collecting cytology cell samples from the endocervix and exocervix is disclosed. The device includes a handle (60) for manipulating and rotating the device. Adjacent the handle is an intermediate cell collecting surface (76) which is sized and configured to scrape cell samples from the exocervix when it is in contact with the exocervix and the device is rotated. The device also includes a distal cell collecting surface (68) adjacent the intermediate cell collecting surface (76). The distal section (68) is sized and configured to scrape cytology cell samples from the endocervical canal when it is located within the canal and in contact with the walls thereof and the device is rotated. The distal and intermediate surfaces (68,76) are so positioned on the device with respect to each other as to enable the endocervical canal and exocervix to be scraped simultaneously as the device is rotated.

Description: The invention relates to a cervical cytology device for simultaneously collecting cytology cell samples from the endocervix and the exocervix, comprising handle means for manipulating and rotating the device and supporting intermediate cell collecting means and distal cell collecting means, the intermediate cell collecting means being sized and configured to scrape cytology cell samples from the exocervix onto its surface when the device is rotated and the intermediate collecting means is in contact with the exocervix, and the distal cell collecting means being sized and configured to scrape cytology cell samples from the endocervix onto its surface when the device is rotated and the distal cell collecting means is in contact with the endocervix. Such a device is known from GB-A-1 378 393. As stated, the device has two regions respectively arranged to scrape cytology cell samples from the exocervix and the endocervix respectively, thus enabling two sets of cell samples to be collected simultaneously during use of the device. In use of the device, the scraped cells are thereafter removed for analysis. Effective analysis requires separate analysis of the cells respectively collected from the exocervix and the endocervix. With the known device, however, removal of the two separate cell samples from the different regions of the device requires considerable care to ensure that the two different cell samples do not become at least partially mixed. This is the problem which the invention aims to overcome. Accordingly, the known device is characterised in that the intermediate cell collecting means and the distal cell collecting means are mechanically separable from each other. In this way, after use of the device the two cell collecting means are mechanically separated and the respective cell samples which they have collected can then be removed for analysis without any risk that they will become inadvertently mixed. Brushes embodying the invention for collecting cytology samples, and methods according to the invention for collecting such samples, will now be described, by way of example only, with reference to the accompanying drawings in which:- Figure 1 is a perspective view of a prior art wooden spatula and an endocervical brush which are used by physicians to scrape cytology cell samples from different areas of a uterus; Figure 2 is an exploded perspective view of one of the brushes embodying the invention, for scraping cytology cell samples from the endocervix and exocervix simultaneously; Figure 3 is a perspective view of a further one of the brushes embodying the invention having separable handle portions; and Figure 4 is an enlarged vertical section taken along line 4-4 of Figure 3. Figure 1 illustrates a prior art wooden spatula 5. Drs. Christine Bergeron, M.D. and Alex Ferenczy, M.D. in their article entitled " Screening Devices for Cervical and Endometrial Ca" published in Contemporary OB-GYN (1987), set forth on pages 55-66 an extensive listing of cervical cytologic sampling and screening devices including wooden spatulas and brushes, and also discuss how the devices should be used to effectively detect the presence of cancer and its precursors. Drs. Bergeron and Ferenczy describe spatula 5 on page 56 of their article as being a tool for sampling the squamocolumnar junction, the exocervix and to a lesser degree the endocervix. As seen in Figure 1, one end of spatula 5 is provided with a handle portion 6 for manipulating the spatula. At its other end, spatula 5 is provided with a long lobe 7 and a short lobe 8. In order to collect cervical cell samples for determining whether any abnormal cells are present, spatula 5 is held by handle 6 and inserted into the vagina until the spatula's short lobe 8 is positioned within the patient's endocervical canal entrance and the spatula's long lobe 7 is positioned against the exocervix. Long lobe 7 is then rotated about the exocervix with the short lobe essentially pivoting in the endocervix canal entrance. As such, the long lobe scrapes and collects cells from the surface of the exocervix. The spatula is then withdrawn from the patient and the cells having been collected on the spatula are then removed therefrom and prepared for examination. Since the spatula's short lobe 8 merely pivots about the endocervical canal entrance, it scrapes and thus collects very few cells from the endocervix. Accordingly, many physicians use other devices to collect endocervical cell samples. Figure 1 also illustrates an endocervical brush 10 which is one of the more commonly used devices for endocervical sampling. One such brush is sold by International Cytobrush, Inc. under the trademark "Cytobrush". Brush 10 has a thin cylindrical stem-like handle 11 which is about 190mm (7.5 inches) long. One end of handle 11 is provided with a generally cylindrical brush portion 12 which is generally about 19mm (0.75 inch) long and about 6.35mm (0.25 inch) in diameter. Drs. Bergeron and Ferenczy point out on page 60 of their article that endocervical samples are taken by inserting the brush into the endocervical canal and then slowly rotating it one-half to one full turn. The brush is then removed from the endocervical canal and a pap smear is prepared by rolling and twisting the brush on a glass slide. Figure 2 illustrates one of the brushes embodying the invention, brush 40, for collecting cell samples from the exocervix and endocervix simultaneously. Brush 40 is provided with two cell collection surfaces, an exocervical brush portion 42 and an endocervical brush portion 44 having bristles 45 at the distal end. While bristled, it should be understood that other materials suitable for collecting cells could also be used, such as urethane or polyurethane. Other possible materials include sponge-like materials and cotton-like materials such as a cotton swab. Endocervical brush portion 44 is similar to the endocervical brush described in Figure 1, i.e., brush 10. Exocervical brush portion 42 is provided with a hollow shaft 46 which is sized and configured to telescope over the shaft of the endocervical brush portion 44 and fixedly or frictionally engage therewith (i.e., by interference fit) to enable the shafts to rotate together when rotated by an attending physician. Fixed engagement could also be provided by making shallow shaft 46 out of a flexible material which would enable it to compress and frictionally engage the surface of shaft 44 when grabbed by a physician. Interlocking ribs on shafts 44 and 46 could also be employed to provide fixed engagement between the shafts. Returning to Figure 2, it can be seen that exocervical brush portion 42 is provided with a disc 48 which is axially disposed on hollow shaft 46 at one end thereof. Disc 48 is provided with bristles 50 on one side and is preferably about 38mm (1.5 inches) in diameter. Bristles 50 form a generally planar brushing surface. In addition, bristles 50 are long enough (preferably 9.5mm (0.375 inch) long), to enable the brushing surface to conform to the surface of the exocervix, even an irregularly shaped exocervix. In use of brush 40, the attending physician (after having opened the patient's vaginal cavity with a vaginal speculum) inserts the brush into the vaginal cavity until the endocervical brush portion is located within the endocervical canal and the brushing surface of disc 48 is positioned against the patient's exocervix. The brush is then rotated one or two times to scrape cell samples from the respective endocervix and exocervix. The brush is then withdrawn from the vaginal cavity and the two brush portions, (i.e., exocervical brush portion 42 and endocervical brush portion 44) are separated. Cell samples on the exocervical brush portion are preferably smeared onto one slide and the cell samples from the exocervical brush portion are preferably smeared on another slide. The slides are then prepared and examined to determine if any abnormalities exist. Thus, the cells of both slides are then placed in a chemical fixative to preserve the cells until they are examined by a pathologist. The pathologist prepares the cells for examination generally by staining them with a Papanicoloff stain. The cells are then examined by the pathologist under a microscope to determine if any abnormal cancerous, precancerous or virally diseased cells are present. A second embodiment in the form of brush 60 is illustrated in Figures 3 and 4. Brush 60 has two cell collection surfaces, an exocervical brush portion 62 and endocervical brush portion 64, the latter having a handle 66, in the form of a rod, with bristles 68 at the distal end. Although it is illustrated as being bristled, it should be understood that other materials suitable for collecting cells could also be used, such as urethane or polyurethane. Conveniently, the brush includes a central wire 70 which extends into a tubular passageway 72 in handle 66. The wire size may be configured to frictionally fit in the passageway or may be secured by a suitable adhesive (not shown). The exocervical brush portion 62 includes a handle 74 in the form of a rod. An exocervical brush 76 has a central wire 78 which extends into a longitudinal passageway 80 of handle 74. This wire is either sized to frictionally fit in passageway 80 or is attached therein by a suitable adhesive (not shown). Conveniently, wire 78 is bent at an angle so that endocervical brush 68 and exocervical brush 78 have an included angle D between them. This angle is conveniently approximately 85 degrees. The brush is used in the same manner as the previous embodiment wherein brush 68 is inserted in the endocervix with the brush 76 contacting the exocervix. The brush 60 is rotated along the longitudinal axis of handle 66 so as to collect endocervix cells on brush 68 and exocervix cells on brush 76. The handle 66 and 74 are attached by a weld or adhesive area 82, shown in Figure 4, which is fracturable. Thus, after the cell samples are collected, the two handles 66 and 74 can be broken apart along the weld 82 and cells on the respective brushes apply to different slides for viewing. From the foregoing, the advantages of the brushes described are readily apparent. A cytology brush has been provided which in the embodiments described includes separate cell collecting surfaces, one for collecting the cells from the endocervix and one for collecting cells from the exocervix. After collection, these cell samples can be placed on separate slides for viewing to determine if the patient has any abnormal cell growth.

Claims: A cervical cytology device for simultaneously collecting cytology cell samples from the endocervix and the exocervix, comprising handle means (42,44;66,74) for manipulating and rotating the device and supporting intermediate cell collecting means (50;76) and distal cell collecting means (45;68), the intermediate cell collecting means (50;76) being sized and configured to scrape cytology cell samples from the exocervix onto its surface when the device is rotated and the intermediate collecting means (50;76) is in contact with the exocervix, and the distal cell collecting means (45;68) being sized and configured to scrape cytology cell samples from the endocervix onto its surface when the device is rotated and the distal cell collecting means (45;68) is in contact with the endocervix, characterised in that the intermediate cell collecting means (50;76) and the distal cell collecting means (45;68) are mechanically separable from each other. A device according to claim 1, characterised in that the intermediate cell collecting means is a surface of a disc (48) which is carried transversely by the handle means (42), and in that the distal cell collecting means (45) is carried on a shaft (44) projecting at right angles outwardly from the said surface of the disc (48). A device according to claim 2, characterised in that the handle means comprises a first hollow shaft carrying the disc (48) at one of its ends, and in that the distal cell collecting means (45) is carried on a second shaft (44) which is telescopically received in said first hollow shaft and frictionally engaged therewithin so that said shafts rotate together to enable the endocervix and exocervix to be scraped simultaneously, said shafts also being separable from one another to facilitate the separate removal and examination of the cell samples collected on the intermediate cell collecting means (48) and those collected on said distal cell collecting means (45). A device according to claim 1, characterised in that said handle means includes a pair of parallel rods (66,74) having surfaces positioned in contiguous relationship, each rod having a distal end and a proximal end, and fracturable means joining said rods (66,74) so that they can be separated after use, said distal cell collecting means (68) being attached to and extending axially from said distal end of one of said rods (66) and said intermediate cell collecting means extending from said distal end of the other of said rods (74). A device according to claim 4, in which said intermediate cell collecting means (76) extends at an angle from said distal end of said other of said rods (74) so that the intermediate cell collecting means (76) and the distal cell collecting means (68) are at an angle with respect to each other. A device according to claim 4 or 5, characterised in that said fracturable means is a fusion of the rods (66,74) along said contiguous surfaces. A device according to any one of claims 4 to 6, characterised in that the said intermediate cell collecting means (76) is rigid yet bendable so that it is capable of being bent to conform to the shape of a particular exocervix and endocervix to be scraped; said rigidity being such that it retains its shape until it is bent again. A device according to any preceding claim, characterised in that the intermediate cell collecting means (28 to 30;50,76) and the distal cell collecting means (30 to 32;45;68) respectively include bristles or bristled regions.

Inventors: ADAIR, EDWIN L., BAYNE, IRMAN DEAN
Applicants: MEDICAL DYNAMICS, INC.
Application year: 1988
Main classification: A61B10
IPC codes: A61B10, A61B17