United States Patent
`
`[19]
`
`[11] Patent Number:
`
`4,762,133
`
`
`
` Bayne et al. [45] Date of Patent: Aug. 9, 1988
`
`
`
`[54] CERVICAL CYTOLOGY DEVICE
`
`trial Ca” published in Contemporary OB-GYN; pp.
`55-66.
`
`[75]
`
`Inventors:
`
`Irman D. Bayne, Littleton; Edwin L.
`Adair, Denver, bOth 0f COIO'
`
`[73] Assignee: Medical Dynamics, Inc., Englewood,
`C010.
`
`Primary Examiner—Kyle L. Howell
`Assistant Examiner—Randy Citrin
`Attorney, Agent, or Firm—Fields, Lewis, Pittenger &
`Rest
`
`[21] Appl. No.: 60,917
`[22] Filed:
`Jun. 12, 1987
`.
`.
`Related U'S° Apphcatlon Data
`.
`.
`.
`commuatlon'm'l’m 0f Ser. N°' 28’458’ Mar. 20’ 1987’
`Pat. N°' 4’754v764'
`4
`[31:00] """"""""""""""""""""1iii/75156113812209"
`'
`'
`' """""""""""""""""""
`128/35’7, 15/164
`.
`’
`[58] Field Of Search """""""" 128/749’ 756’ 757’ 759’
`128/357; 15/164’ 165’ 106
`References Cited
`
`[62]
`
`i2]
`
`[56]
`
`U'S' PATENT DOCUMENTS
`680,427
`8/1901 Carryl ................................... 15/106
`3,626,470 12/1971 Antonides et a1. .................. 128/759
`3,881,464
`5/1975 , Levene -
`4,448,205
`5/1984 Stenkvist ............................. 128/757
`
`OTHER PUBLICATIONS
`
`57
`
`ABSTRACT
`
`l
`i
`A method and device for simultaneously collecting
`cytology cell samples from the endocervix and exocer-
`vix are disclosed. The device includes a handle for ma-
`nipulating and rotating the device. Adjacent the handle
`is an intermediate cell collecting surface which is sized
`and configured to scrape cell samples from the exocer-
`vix when it is in contact with the exocervix and the
`device is rotated. The device also includes a distal cell
`collecting surface adjacent the intermediate cell collect-
`ing surface. The distal section 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 dev1ce ls rotated. The
`distal and intermediate surface are further positioned on
`the device with respect to each other to enable the
`endocervical canal and exocervix to be scraped simulta-
`neously as the device is rotated.
`
`Drs. Christine Bergeron, MD. and Alex Ferenczy,
`M.D. “Screening Devices for Cervical and Endome-
`
`10 Claims, 2 Drawing Sheets
`
`Exhibit 1016
`
`Histologics, LLC
`
`1
`
`

`

`US. Patent
`
`Aug. 9, 1988
`
`Sheet 1 of2
`
`4,762,133
`
`
`
`2
`
`

`

`US. Patent
`
`Aug. 9, 1988
`
`Sheet 2 of2
`
`4,762,133
`
`62
`
`
`
`3
`
`

`

`1
`CERVICAL CYTOLOGY DEVICE
`
`4,762,133
`
`This application is a continuation-in-part of Ser. No.
`28,458, filed Mar. 20, 1987, now US. Pat. No. 4,754,764.
`TECHNICAL FIELD
`
`«
`
`The invention relates generally to a method and ap-
`paratus for collecting cell specimens for diagnostic pur-
`poses and more particularly to a cervical cytology de-
`vice and method for collecting cytology cell samples
`from the uterine endocervix and exocervix.
`
`BACKGROUND ART
`
`2
`broad form the device includes a handle for manipulat-
`ing and rotating the device, an intermediate cell collect-
`ing surface region adjacent
`the handle for scraping
`cytology cells from the exocervix and a distal cell col-
`lecting surface adjacent the intermediate cell collecting
`surface for scraping cytology cells from the endocervi-
`cal canal. The cell collecting surfaces are sized and
`configured to be capable of scraping cytology cell sam-
`ples from their respective cervical areas when they are
`in contact with their respective regions of the cervix the
`device is rotated. The distal and intermediate cell col-
`lecting surfaces also positioned with respect to each
`other on the device so as to enable the endocervical
`canal and exocervix to be scraped simultaneously as the
`device is rotated.
`
`10
`
`15
`
`A first embodiment of the cervical cytology device of
`the present invention is a brush which includes a rigid
`yet bendable shaft having less than three bends which
`define four sections of the brush. The first bend joins an
`outwardly projecting or distal cell collecting surface
`and an intermediate cell collecting surface of the brush.
`The bend is provided such that the cell collecting sur-
`faces define less than a 90° included angle between their
`respective shafts. The second bend on the brush’s shaft
`adjoins the intermediate cell collecting surface and an
`‘ offset intermediate section, and the bend is such that the
`intermediate sections define approximately a 10° in-
`cluded angle. The third bend joins the intermediate
`offset section and an outwardly projectingvhandle sec-
`tion of the brush. This third bend is such that the offset
`and handle sections define at least a 90° included angle.
`The bends are also provided so that the distal and han-
`dle sections of the brush are axially aligned. In addition,
`the distal cell collecting surface of the brush is sized and
`configured to collect cytology cell samples from the
`endocervical canal when the brush is rotated and the
`distal cell collecting surfacelis located within the canal
`and in contact with the wall thereof. The intermediate
`cell collecting surface is also sized and configured to
`collect cytology cell samples from the surface of the
`exocervix as the distal cell collecting surface is rotated
`to collect cytology cell samples from the endocervical
`canal. Accordingly, cell samples from the endocervical
`and exocervical surface can be collected simulta-
`neously.
`The angles described above between the different
`sections of the brush can be altered at will by the physi-
`cians by bending the shaft of the brush. The physician,
`in effect, can mold the brush to “customize” a “fit” for
`each individual patient.
`In a second embodiment, a distal bristled region is
`attached to the distal end of a handle and extends axially
`therefrom. An intermediate bristled region is attached
`to a disc which surrounds and extends at right angles
`from a hollow shaft which telescopicly and fixedly
`engages the distal bristled region shaft and extends sub-
`stantially the length thereof. With the two portions
`assembled, the distal bristled region is inserted in the
`endocervix with the bristled region of the disc against
`the exocervix. The entire device is rotated so as to col-
`
`lect cells on the respective bristled portions. The por-
`tions are then separated from each other whereupon the
`cells collected on the distal bristled portion from the
`endocervix can be applied to a first slide and cells col-
`lected on the intermediate bristled portion of the disc
`from the exocervix can be placed on a second slide.
`
`It is well-known that uterine cervical cancer can be
`prevented and/or even cured if it
`is detected early
`enough, preferably in its precancerous or precursor
`stages. Accordingly, women are being encouraged to
`come in for examinations on a regular basis. Improve-
`ments in early detection devices and techniques will
`also, quite obviously, enhance the physician’s ability to
`accurately detect the presence of cancer in its early
`stages. Accordingly, much effort is being directed to
`developing such devices.
`Drs. Christine Bergeron, MD. and Alex Ferenczy,
`MD. in their article entitled “Screening Devicesfor Cer-
`vical 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 effec-
`tively detect the presence of cancer and its precursors.
`US. Pat. No. 3,881,464 to Levene also discloses a
`device for obtaining endocervical cell and tissue sam~ '
`ples. The device comprises a generally frusto conical
`brush having a coaxial handle projecting from its larger
`end. The frusto conical brush consists of soft radially
`projecting bristles of cellulose acetate which are soluble
`in a liquid that does not cause morphological damage
`when the bristles and cell samples are immersed in the
`liquid. While useful in obtaining cell samples from the
`endocervical canal, the brush’s frusto conical shape
`does not lend itself to collecting cells from the exocer-
`v1x.
`
`20
`
`25
`
`30
`
`35
`
`While the aforementioned devices undoubtedly work
`as intended, there is still a need for devices which are
`capable of collecting samples containing more cells,
`particularly from the exocervix area. The aforemen-
`tioned wooden spatula does’ not generally collect
`enough cells from the exocervix to enable one to accu-
`rately determine whether any abnormal cells are pres-
`ent. The problem is even worse with women who have
`an abnormally or unusually shaped exocervix since the
`spatula’s long rigid lobe may not even make contact
`with the exocervix. Accordingly, a need still exists for a
`device which is capable of collecting larger cell samples
`from the uterine exocervix. Such a device would be
`even more desirable if it also had the capability of col-
`lecting cell samples from the endocervical canal. Such a
`device would make better use of the physician’s time
`and be more palatable to the patient since it would
`enable the samples to be taken quicker. Such a device
`would also be more accurate than presently available
`devices since it would make it possible to collect larger
`cell samples from the exocervix.
`DISCLOSURE OF THE INVENTION
`
`The present invention addresses the aforementioned
`concerns and needs by providing a cervical cytology
`device for simultaneously collecting cytology cell sam-
`ples from the uterine endocervix and exocervix. In its
`
`45
`
`50
`
`55
`
`60
`
`65
`
`4
`
`

`

`4,762,133
`
`3
`In a third embodiment, a distal bristled portion is
`provided which is attached to a handle, which is sub-
`stantially identical to that of the previous embodiment.
`However, the intermediate bristled portion is provided
`on a second identical handle and extends at an angle to
`the distal brush. The two handles are attached to each
`other alongltheir contiguous surfaces by a fracturable
`adhesive or weld. When in the assembled welded condi-
`
`4
`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 spatu-
`la’s short lobe 8 is positioned within the patient’s endo-
`cervical 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 essen—
`
`tion, the brushes are used as described with respect to
`the previous embodiment. After the cells have been
`collected, the handles are broken apart along the frac-
`turable weld and the cell samples placed on separate
`slides for viewing.
`The present
`invention also provides a method of
`collecting cytology cell samples from the endocervix
`and exocervix simultaneously. The method includes
`providing a rotatable cervical cytology device having a
`first cell collecting surface which is sized and config-
`ured to collect cells from the exocervix and a second
`cell collecting surface which is sized and configured to
`collect cells from the endocervical canal where the
`
`device is rotated. The method further includes inserting
`the second cell collecting surface into the endocervical
`canal until the first cell collecting surface is positioned
`against the surface of the exocervix. The device is then
`rotated so that cytology cell samples are scraped from
`the respective surfaces of the exocervix and endocervix
`simultaneously. As such, the cell samples will collect on
`the respective first and second cell collecting surface of
`the device. The device is then withdrawn from the
`patient. The samples are then removed from the device
`and examined to determine whether any abnormal can-
`cerous, precancerous or virally diseased cells are pres-
`ent.
`
`Additional advantages of this invention will become
`apparent from the detailed description which follows,
`taken in conjunction with the accompanying drawings.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of a conventional prior
`art wooden spatula and an endocervical brush which
`are used by physicians to scrape cytology cell samples
`from different areas of a uterus.
`FIG. 2 is a perspective view of a preferred embodi-
`ment of the present invention for scraping cytology cell
`samples from the endocervix and exocervix simulta-
`neously.
`'
`-
`FIG. 3 is an exploded perspective view of another
`embodiment of the present invention for scraping cytol-
`ogy cell samples from the endocervix and exocervix
`simultaneously.
`FIG. 4 is a perspective view of a preferred embodi-
`ment of the invention having separable handle portions.
`FIG. 5 is an enlarged vertical section, taken along line
`5—5 of FIG. 4.
`
`FIG. 6 is a fragmentary perspective view of an alter-
`native device wherein the collecting surfaces are
`sponge-like closed cell foam or cotton swab material.
`BEST MODE FOR CARRYING OUT THE
`INVENTION
`
`FIG. 1 illustrates a conventional wooden spatula 5.
`Drs. Bergeron and Ferenczy describe spatula 5 on page
`56 of their above-mentioned article as being a tool for
`sampling the squamocolumnar junction, the exocervix
`and to a lesser degree the endocervix. As seen in FIG.
`1, one end of spatula 5 is provided with a handle portion
`6 for manipulating the spatula. At its other end, spatula
`
`10
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`15
`
`20
`
`25
`
`30
`
`35
`
`4O
`
`tially 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. Accord-
`ingly, many physicians use other devices to collect
`endocervical cell samples. FIG. 1 also illustrates an
`endocervical brush 10 which is one of the more com-
`monly 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 7%” long.
`One end of handle 11 is provided with a generally cylin-
`drical brush portion 12 which is generally about %" long
`and about i" 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 endo-
`cervical canal and then slowing rotating it one-half to
`one full turn. The brush is then removed from the endo-
`cervical canal and a pap smear is prepared by rolling
`and twisting the brush on a glass slide.
`FIG. 2 illustrates a first embodiment of a brush 20 of
`the present invention which is used for collecting cytol-
`ogy cell samples from the uterine endocervix and ex-
`ocervix simultaneously. Brush 20 includes a handle 22
`preferably made from a suitable material, such as, plas-
`tic, which is mounted on a shaft 24. It can also be seen
`that shaft 24 is bent in three places which are identified
`as bends 26, 28 and 30. Brush 20 is provided with a
`plurality of radially projecting bristles 32 which extend
`from bend 28 to the distal end of the brush. The bristles
`
`45
`
`extending between bend 30 and 28 define a generally
`cylindrically shaped cell collecting surface which is
`referred herein as the intermediate bristled section of
`
`50
`
`55
`
`60
`
`65
`
`brush 20. It can also be seen that bristles 32 gradually
`taper from bend 30 to the brush’s distal end and, as such,
`define a generally conical cell collecting surface which
`is referred to herein as the distal bristled section of the
`brush. The nonbristled area of shaft 24 between bends
`28 and 26 is referred to herein as the intermediate offset
`section of the brush. The diameter of the intermediate
`bristled section (i.e.
`its brush portion) is preferably
`about I". The diameter of the distal bristled section
`preferably tapers from about I” at bend 30 to approxi-
`mately fi” at the brush’s distal end.
`Bristles 32 are secured to shaft 24 in the conventional
`helically wound manner (not shown). Accordingly,
`those skilled in the relevant art will recognize that shaft
`24 comprises a pair of strands twisted together. The
`bristles are tightly secured to the shaft by being inter-
`posed between the twisted strands of the shaft.
`While the cell collecting surfaces are bristled in the
`illustrated embodiment
`it should be understood that
`they could be made in accordance with the present
`invention from material which is suitable for collecting
`or scraping cells from the respective cervical surfaces.
`
`5
`
`

`

`5
`Such materials include closed cell foam materials such
`as urethane and polyurethane. Other possible materials
`include sponge-like materials and cotton-like materials
`such as a cotton swab.
`Returning to FIG. 2, bend 30 defines an included
`angle A between the distal and intermediate bristled
`sections which is less than 90°, preferably about 85°.
`Bend 26 between the nonbristled intermediate offset
`section and the handle section of brush 20 also prefera-
`bly defines an included angle C of about 100°. Included
`angle B defined by bend 28 between the intermediate
`sections is preferably 10" or greater. In addition, the
`portions of shaft 24 extending through the distal bristled
`section and the handle section are preferably axially
`aligned. Further, the height of the offset portions is
`preferably 2" as measured from bend 28 to an imaginary
`line extending between the angled axis of the handle and
`distal shaft. A brush manufactured as described will
`conform to the shape of most womens uterine cervixes.
`However, shaft 24 may be bent to conform to an irregu-
`larly shaped cervix. The angle of the bends may also be
`altered by the physician to custom fit each patient, as
`required.
`In using brush 20 of the present invention, the pa-
`tient’s vaginal cavity is first opened wide, preferably
`with a vaginal speculum. This permits brush 20 to be
`easily inserted into the vaginal cavity. The attending
`physician can also look into the vaginal cavity to see
`whether the exocervix of the patient
`is unusually
`shaped, and if so the physician can bend the brush so
`that it conforms to the irregularly shaped exocervix.
`The physician then inserts the brush into the patient’s
`vaginal cavity until the distal bristled end of the brush is
`inserted within the endocervical canal and the interme-
`diate bristled section of the brush is in contact with the
`exocervix. The intermediate bristled section should be
`in contact with the exocervix along its entire length (i.e.
`from bend 30 to bend 28). If it is not, it should be bent
`as previously described until it makes such contact. The
`physician then rotates the brush by rotating the brush
`handle with his hand so that the bristles of the interme-
`diate bristled section scrape cell samples from the ex-
`ocervix. As this occurs, cell samples will also be scraped
`from the endocervical canal walls by the distal bristled
`section of the brush which will be rotating within the
`endocervical canal as the brush rotates. After a suitable
`sample of cells is collected from the endocervix and
`exocervix, generally after one or two rotations of the
`brush, the brush is withdrawn from the vaginal cavity.
`The cell samples on the bristles of the respective brush
`portions are then removed from the bristles. Since the
`endocervical and exocervical samples are preferably
`analyzed separately, the endocervical cells on the distal
`bristled portion of the brush are removed by smearing
`them along the length of a first glass side which prefera-
`bly is done by slowly rotating the distal end of the brush
`on the slide. The exocervical cells on the intermediate
`bristled portion of the brush are removed therefrom
`similarly by smearing them along the length of a second
`glass slide. 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.
`
`10
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`4,762,133
`
`6
`A brush similar to that described in FIG. 2 was tested
`and found to collect exceedingly good samples, particu-
`larly exocervical samples. In fact, the exocervical sam-
`ples contained on average approximately five times as
`many cells as those collected by the conventional
`wooden spatula. These large samples will enhance the
`physician’s ability to more accurately detect the pres-
`ence of abnormal cancerous and precancerous cells.
`The samples have also been large enough to enable
`physicians to detect the presence of virally diseased
`cells such as herpes.
`FIG. 3 illustrates an alternative brush 40 of the pres-
`ent invention for collecting cell samples from the ex-
`ocervix and endocervix simultaneously. Brush 40 is
`provided with two cell collection surfaces, an exocervi-
`cal brush portion 42 and an endocervical brush portion
`44 having bristles 45 at the distal end. While bristled, it
`should again be understood that other materials suitable
`for collecting cells could also be used such as urethane
`or polyurethane.
`Endocervical brush portion 44 is similar to the endo-
`cervical brush described in FIG. 1, i.e., brush 10. Ex-
`ocervical 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 interfer-
`ence 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 engage-
`ment between the shafts.
`Returning to FIG. 3, 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 1%” in diameter. Bristles 50 form a
`generally planar brushing surface. In addition, bristles
`50 are long enough (preferably %” long), to enable the
`brushing surface to conform to the surface of the ex-
`ocervix, even an irregularly shaped exocervix.
`Use of brush 40 is similar to that of brush 20 previ-
`ously described. The attending physician (after having
`opened the patient’s vaginal cavity with a vaginal spec-
`ulum) inserts the brush into the vaginal cavity until the
`endocervical brush portion is located within the endo-
`cervical 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 endocervicalbrush 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 exam-
`ined to determine if any abnormalities exist.
`A third embodiment in the form of brush 60 is illus-
`trated in FIGS. 4 and 5. Brush 60 has two cell collection
`surfaces, an exocervical brush portion 62 and endocer-
`vical brush portion 64, the later 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 84 suitable for collect-
`ing cells could also be used, such as a cotton swab or a
`
`6
`
`

`

`4,762,133
`
`7
`sponge-like material such as urethane or polyurethane
`after foam as shown in FIG. 6. Conveniently, the brush
`includes a central wire 70 which extends into a tubular
`passageway 72 in handle 66. The wire size may be con-
`figured 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
`
`8
`to said distal end of said other rod so that said
`intermediate cell collecting surface extends at an
`angle from said other rod, said distal cell collecting
`surface and said intermediate cell collecting surface
`cooperating, respectfully, to simultaneously scrape
`cytology cell samples from the endocervix and
`exocervix, respectfully, when said handle means is
`rotated and said distal and intermediate cell collect-
`
`ing surfaces are in contact, respectfully, with the
`endocervix and exocervix.
`2. A device, as claimed in claim 1, wherein:
`each of said intermediate and said distal cell collect-
`
`ing surfaces includes a shaft provided with a plural-
`ity of bristles attached to and projecting radially
`from said shaft, said bristles of each surface form-
`ing a generally cylindrical or conical brush portion.
`3. A device, as claimed in claim 2, wherein:
`each of said rods is tubular;
`said shaft of said distal surface is fixed in said distal
`end of one of said rods; and
`said shaft of said intermediate surface is fixed in said
`distal end of said other rod; said shaft of said inter-
`mediate surface being bent at an angle beyond said
`distal end of said other rod so that said distal sur-
`
`face and said intermediate surface are at an angle
`with respect to each other.
`4. A device as claimed in claim 3 wherein:
`the included angle between said shafts of said distal
`surface and said intermediate surface is approxi-
`mately 85°.
`5. A device as claimed in claim 1, wherein:
`at least one of said cell collecting surfaces includes
`closed cell foam for collecting cytology cell sam-
`ples.
`6. A device as claimed in claim 5, wherein:
`said closed cell foam is selected from the group con-
`sisting of urethane or polyurethane.
`7. A device as claimed in claim 1, wherein:
`at least one of said cell collecting surfaces includes
`sponge-like material for collecting cytology cell
`samples.
`8. A device as claimed in claim 1, wherein:
`at least one of said cell collecting surfaces includes a
`cotton swab or cotton-like material for collecting
`cytology cell samples.
`9. A device as claimed in claim 1, wherein:
`said brush is rigid yet bendable so that said brush is
`capable of being bent to conform to the shape of a
`particular exocervix and endocervix to be scraped,
`said rigidity being such that said brush retains its
`shape until it is bent again.
`10. A device as claimed in claim 1, wherein said frac-
`turable mean is:
`
`a fusion of the rods along said contiguous surfaces.
`*
`*
`*
`*
`*
`
`central wire 78 which extends into a longitudinal pas-
`sageway 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 exocer-
`vix. 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
`FIG. 5 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 this invention
`are readily apparent. A cytology brush has been pro-
`vided which in the various embodiments includes sepa-
`rate 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.
`The invention has been described in detail with par-
`ticular reference to several embodiments thereof, but it
`will be understood that variations and modifications can
`be effected within the spirit and scope of the invention.
`We claim:
`
`1. A cervical cytology device for simultaneously
`collecting cytology cell samples from the endocervix
`and exocervix, said device comprising:
`handle means for manipulating and rotating said de-
`vice, said handle means including a pair of parallel
`rods having surfaces positioned in contiguous rela-
`tionship, each rod having a distal end and a proxi-
`mal end;
`fracturable means joining said rods so that they can
`be separated after use;
`a distal cell collecting surface sized and configured to
`scrape cytology cell samples from the endocervix,
`said distal surface being attached to and extending
`axially from said distal end of one of said rods; and
`an intermediate cell collecting surface sized and con-
`figured to scrape cytology cell samples from said
`exocervix, said intermediate surface being attached
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`4s
`
`50
`
`55
`
`60
`
`65
`
`7
`
`