[54] CERVICAL CYTOLOGY DEVICE
`‘
`.
`Inventor.
`Irman D' Bayne, Littleton, COIO'
`[75]
`[73] Assignee: Medical Dynamics, Inc., Englewood,
`C010.
`[21] Appl. No.: 28,458
`.
`Mar. 20’ 1987
`[22] F‘led‘
`[51]
`Int. Cl.4 .............................................. A61B 10/00
`[52] US. Cl. .................................... 128/756; 128/759;
`128/357; 15/159 A; 15/180
`[58] Field of Search ............... 128/749, 756, 757, 759,
`128/357; D4/ 119, 120, 127, 128, 130-135;
`15/ 159 R, 159 A, 204, 179, 130
`
`[56]
`
`References Cited
`
`U'S' PATENT DOCUMENTS
`2,174,214 9/1939 Quinn .................................... 15/ 180
`3,525,470 12/1971 Antonides 6‘ 31-
`'
`----- 123/759
`3:33:35 33;: Is.tevine t"""""""
`" 151/2159];
`’
`’
`en V15 """"""""""""""""
`OTHER PUBLICATIONS
`Christine Bergeron, M. D. and Alex Ferenczy, M. D.,
`Screening Devices for Cervical and Endometrial Ca Con-
`temporary OB/GYN, 1987.
`
`Primary Examiner—Kyle L. Howell
`Assistant Examiner—Randy Citrin
`Attorney, Agent, or Firm—Fields, Lewis, Pittenger &
`Rost
`
`ABSTRACT
`_
`[57]
`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 device is 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.
`
`, 6 Claims, 1 Drawing Sheet
`
`United States Patent
`
`[19]
`
`[11] Patent Number:
`
`4,754,764
`
`Bayne
`
`[45] Date of Patent:
`
`Jul. 5, 1988
`
` Histologics, LL
`
`1
`
`Exhibit 1009
`
`1
`
`

`

`US. Patent
`
`Jul. 5, 1988
`
`4,754,764
`
`6 F
`
`IG.1
`(PRIOR ART)
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`2
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`1
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`CERVICAL CYTOLOGY DEVICE
`
`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
`
`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, M.D. and Alex Ferenczy,
`M.D. in their article entitled “Screening Devices for Cer-
`vical and Endomem‘al 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-
`le.
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`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
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`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.’
`
`A preferred embodiment of the cervical cytology
`device of the present invention is a brush which in-
`cludes 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 collect-
`ing surface and an intermediate cell collecting surface of
`the brush. The bend is provided such that the cell col-
`lecting surfaces 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 approxi-
`mately a 10° included angle. The third bend joins the
`intermediate offset section and an outwardly projecting
`handle section of the brush. This third bend is such that
`the offset and handle sections define at least a 90° in-
`cluded angle. The bends are also provided so that the
`distal and handle 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 surface is
`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 col-
`lecting surface is rotated to collect cytology cell sam-
`ples from the endocervical canal. Accordingly, cell
`samples from the endocervical and exocervical surface
`can be collected simultaneously.
`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.
`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
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`tie
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`4. ”754,764-
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`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 fragmentary perspective View of an alter-
`native embodiment of the 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
`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—
`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 cylinm
`drical brush portion 12 which is generally about 2” long
`and about 3;" 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.
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`FIG. 2 illustrates a preferred embodiment of a brush
`20 of the present invention which is used for collecting
`cytology cell samples from the uterine endocervix and
`exocervix 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
`extending between bend 30 and 28 define a generally
`cylindrically shaped cell collecting surface which is
`referred herein as the intermediate bristled section of
`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 t" 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 intern
`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.
`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 3" 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
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`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.
`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 as shown in FIG. 4 with collecting
`surfaces 45’ and 50'.
`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
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`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 8" 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 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 exam-
`ined to determine if any abnormalities exist.
`The invention has been described in detail with par-
`ticular reference to two preferred embodiments thereof,
`but it will be understood that variations and modifica-
`tions can be effected within the spirit and scope of the
`invention.
`I claim:
`1. A cervical cytology device for simultaneously
`collecting cytology cell samples from the endocervix
`and exocervix, said device comprising:
`a handle having a first hollow shaft for manipulating
`and rotating said device;
`intermediate cell collecting means including a disc
`which is rigidly attached to an end of said hollow
`shaft, said hollow shaft projecting outwardly at a
`right angle from one side of said disc, the other side
`of said disc being provided with a generally planar
`cell collecting surface for scraping cytology cell
`samples from the exocervix; and
`distal cell collecting means including a second shaft
`having a generally cylindrical cell collecting sur-
`face attached to an end of said second shaft for
`scraping cytology cell samples from the endocer-
`vix, said second shaft being telescopingly received
`in said first hollow shaft of said handle so that said
`cylindrical collecting surface projects outwardly at
`a right angle from said planar collecting surface,
`said second shaft being frictionally engaged within
`said first hollow shaft when telescoping received
`therewith so that said shafts rotate together to
`enable the endocervix and exocervix to be scraped
`simultaneously, thereby enabling the cell samples
`to be collected simultaneously, said shafts also
`being separable from one another to facilitate the
`separate removal and examination of the cell sam-
`ples collected on said planar surface from those
`collected on said cylindrical surface.
`2. A device as claimed in claim 1, wherein:
`at least one of said cell collecting surfaces includes
`bristles forming a brushing surface for collecting
`cytology cell samples.
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`l
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`4-.”7lfl4-97ll41
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`‘8
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`sponge-lilac material for collecting cytology cell
`samples.
`6. A device as claimed in claim 1, wherein:
`
`at least one of said cell collecting surfaces includes a
`cotton swab or cottonulike material for collecting
`cytology cell samples.
`it
`II:
`3k
`1k
`it
`
`‘
`3' A dEVlC‘B as claimed m claiml. wherein:
`at least one of said cell collecting surfaces includes
`closed cell foam for collecting cytology cell sam»
`ples.
`4- A dCViCB as claimed in claim 3, wherein:
`82ml closed CB“ foam 13 55.16th from the group con-l
`sxstmg of urethane or polyurethane.
`S. A device as claimed in claim 1. wherein:
`at least one of said cell collecting surfaces includes
`
`K3
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`10
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`l. 1'5
`
`\
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`40
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`L}: La
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`60
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`6
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`