USO05l91899A
`5,191,899
`[11] Patent Number:
`[19]
`Ulllted States Patent
`
`Strickland et al.
`[45] Date of Patent:
`Mar. 9, 1993
`
`[54] PAP SMEAR COLLECTION DEVICE WITH
`BRIS-I-LES ORIENTED IN A PLANE
`
`FOREIGN PATENT DOCUMENTS
`653880
`1/1986 Switzerland ........................ 128/757
`
`[75]
`
`Inventors: Richard D. Strickland, Sandy, Utah;
`Geno Siiccomanno, Grand Junction,
`C010‘
`
`.
`
`_
`.
`[73] Assignee: Baal Associates, Inc., Sandy, Utah
`
`2204496 ll/1988 United Kingdom ................ 128/757
`P”-mary Exam,-ner_Max Hindenburg
`Assistant Examiner—Guy V. Tucker
`Attorney, Agent, or F1'rm—Workman, Nydegger &
`Jensen
`
`ABSTRACT
`[57],
`A device for simultaneous collection of cells from the
`endocervical canal and the cervical face of the uterus
`and methods of use. The device is an elongated handle
`having one cell-collecting member projecting from the
`handle at an axis perpendicular to the axis of the handle
`for contacting with the cervical face of the uterus, and
`one cell-collecting member projecting from the handle
`along the same axis as the handle for contacting with
`the endocervical canal of the uterus. Along each mem-
`ber project sets of_bristles which, because they ‘are per-
`pendicularly positioned on each member, provide mild
`abrasive action to the endocgrvical gang] and thg C51-Vi-
`cal face when the device is inserted into the uterus and
`tat d
`th t
`11
`f
`b th
`'
`11
`t d
`:f;uo'ih’eS,§’fiSfl:S Ce 5 mm °
`regms are C0 6° C
`'
`_
`_
`The cells are removed from the bristles either by bend-
`ing a flexible portion of the handle to enable parallel
`smearing of the cells onto a microscope slide, or by
`dislodging the cells from the bristles of the device into
`a fixative solution by manually rotating the device.
`After the solution is centrifuged, the cells form a cell
`pellet which is then smeared onto a microscope slide as
`3 5111819 lay“ °f “"5-
`
`36 Claims, 6 Drawing Sheets
`
`[213 Appl. No.: sos,5s3
`
`[22] Filed:
`
`Dec. 12, 1991
`
`Int. Cl.5 ............................................ .. A6lB 10/00
`[51]
`[52] U.S. Cl. ......... ..
`......... .. 128/756; 128/759
`
`............. .. 128/749, 756, 757, 759,
`[58] Field of Search
`128/778; 15/159 A; 606/161
`
`References Cited
`U_S' PATENT DOCUMENTS
`Re. 27,915 2/1974 K0111 .................................. .. 128/757
`3»435v235 12/1959 FY05‘
`123/757
`3,613,664 10/1971 Willson
`128/756
`3,633,565
`1/1972 McDonald ..
`128/2R
`3,774,590 11/1973 McDonald ..
`128/2 B
`3,331,454
`5/1975 Levene _, ,, _ _,
`,, . ,. 123/2 13
`4,078,656
`3/1978 Crane et al.
`206/223
`4,127,113 11/1978 Nollan --------
`128/2 W
`4:334-587 5/ 1933 Milsrom -
`123/757
`4,700,713 l0/1987 Kist
`. .. . .
`. .. .. 128/756
`4,754,764
`7/1988 Bayne ..
`128/756
`4,759,376
`7/1988 Storrnby .. . . .
`.. . .. 128/756
`4,762,133
`8/1988 Bayne et a]_ N
`128/756
`4,873,992 10/1939 Bayne .............
`..... 128/756
`4,98l,l43
`1/1991 Sakita et al.
`128/757
`5,022,408
`6/1991 Mohajer .............................. 128/756
`
`
`
`[56]
`
`
`
`Histologics, LLC
`
`Exhibit 1008
`
`1
`
`

`
`U.S. Patent
`
`-.
`
`Mar. 9, 1993
`
`Sheet 1 of6
`
`5,191,899
`
`<\l
`
`<9’
`Ln.
`
`£
`g"'%
`
`383
`
`2.’
`
`TS
`
`<5
`LI-
`
`2
`
`

`
`U.S. Patent
`
`Mar. 9, 1993
`
`Sheet 2 of 6
`
`‘
`
`5,191,899
`
`3
`
`

`
`U.S. Patent
`
`Mar. 9, 1993 "
`
`Sheet 3 of 6
`
`5,191,899
`
`\
`
`4
`
`

`
`U.S. Patent
`
`Mar. 9, 1993
`
`Sheet 4 of 6
`
`_
`
`FIG.
`
`5
`
`5
`
`

`
`6
`
`

`
`U.S. Patent _
`
`Mar. 9, 1993
`
`Sheet 6 of 6
`
`'
`
`5,191,899
`
`7
`
`

`
`1
`
`5,191,899
`
`2
`If bleeding occurs during collection, the red blood
`cells may obscure other cells on the cytology slide and
`make interpretation difficult or impossible. When this
`happens,
`the cell collection procedure must be re-
`peated. As many “Pap smears” are performed in public
`health clinics and similar free or low-cost environments,
`the device to be used must not substantially increase the
`material costs of the procedure.
`Another disadvantage to the cytology brush has been
`that entry of the brush into the endocervical canal‘ is
`difficult to control. If the brush is extended too far
`inside the canal, injury to the endocervix may result. It
`is difficult for the user to determine proper penetration
`of the cytology brush.
`,
`Recently, some changes in the design of cytology
`brushes have been taking place, aimed primarily at de-
`creasing the incidence of cervical bleeding and improv-
`ing the ease with which cells are extracted from the
`bristles. These changes have been somewhat effective
`but have typically further increased the cost of the
`brushes.
`
`One change has been to design a broom-like device to
`simultaneously collect cells from the ectocervix and
`endocervix. This brush has bristles which extend for-
`ward from a cross piece and looks very much like a
`broom. The central bristles are longer than the lateral
`bristles and are intended to enter the endocervical canal
`while the lateral bristles make contact with the ectocer-
`vix. The collection difficulties arise from the fact that
`the central bristles are parallel to the walls of the endo-
`cervical canal and, thus, very little abrasive effect is
`generated, especially if there is any dilation of the canal.
`As a result, endocervical cells are not consistently col-
`lected.
`Further disadvantages of the prior art devices are in
`transferring the cells for examination. After cells have
`been collected, they are usually transferred to a micro-
`scopic slide for later examination. This is accomplished
`by wiping the collecting apparatus, whether spatula,
`brush swab, or broom, directly against the surface of the
`slide. A fixative is then applied to avoid any deteriora-
`tion of the cells before the cytology technician and/or
`pathologist can examine them. Unfortunately, many
`doctors lack time and patience to transfer every col-
`lected cell from the device with a microscopic slide and
`so valuable diagnostic material may be lost, resulting in
`risk of erroneous diagnosis. With the spiral brush, it is
`and excess time and care to do so is necessary. In some
`cases, the presence of mucous or blood or the knowl-
`edge that the patient is at high risk, can make this type
`of slide preparation inadequate. A monocellular prepa-
`ration may be requested. In this technique, the samples
`must be transferred from the collection device(s) into a
`container of fixative. The container is then centrifuged
`until all cellular components have collected at the bot-
`tom of the container as a “cell pellet.” After the excess
`fixative is pipetted off, the cell pellet can be spread
`evenly onto a slide. This provides a slide with very little
`cellular overlap. Mucous will have gone into solution
`and any red blood cells will be sufficiently spread so as
`to avoid obscuring other cells.
`BRIEF SUMMARY AND OBJECTS OF THE,
`INVENTION
`
`PAP SMEAR COLLECTION DEVICE WITH —
`BRISTLES ORIENTED IN A PLANE
`
`BACKGROUND
`l. The Field of the Invention
`
`5
`
`l0
`
`15
`
`20
`
`30
`
`35
`
`45
`
`50
`
`55
`
`The present invention relates generally to apparatus
`and methods for use in the collection of a Pap smear.
`More particularly,
`the present
`invention provides a
`novel design which permits simultaneous collection of
`cells from the cervical face and from the endocervical
`canal. The device also provides a method and means for
`securing a vaginal sample without reverting to a second
`sampling device.
`2. The Background of the Invention
`Over the last 40 years, the death rate from cervical
`cancer has dropped dramatically due to the widespread
`use of the Papanicolaou (“Pap”) test. This test involves
`the collection of cells from the cervical face, the endo-
`cervical canal and occasionally from the vaginal wall.
`These cells are then microscopically examined for evi-
`dence of precancerous or cancerous growth. The peri-
`odic use of this test permits early detection of malig-
`nancy so that palliative therapy can be initiated at a time 25
`when it will yield the highest possible success rate.
`For many years the standard method for collection of
`these cells has been a wooden or plastic spatula. A
`variety of slightly different shapes have been used in an
`effort to allow the clinician to collect cells from the
`cervical face as well as the endocervical canal. In some
`cases, the opposite end of the spatula was designed to
`collect a vaginal scraping.
`For the most part, these designs have been able to
`retrieve cells from the surface of the cervix and the
`vaginal wall but have frequently failed to collect ade-
`quate cell samples from the endocervical canal. This has
`been a serious problem because any sample which does
`not include endocervical cells is deemed to be inade-
`quate for proper interpretation and diagnosis. Further,
`many women who have had_an inadequate sample taken
`are reluctant to have the procedure repeated and may
`be placed at risk for progression of their disease until
`their next periodic checkup.
`A delay in the diagnosis of cervical or uterine cancer
`can result in the need for far more radical treatment
`procedures than would be needed if the cancer were
`detected earlier. In the worst case, a delay in diagnosis
`could result in the progression from treatable cancer to
`a terminal cancer.
`Recent modifications in collection procedures have
`added a cotton swab to the technique in an effort to
`collect’ endocervical cells. The cotton swab is inserted
`into the cervical canal and rotated. Although the cotton
`swab may somewhat improve the yield, it is not abra-
`sive enough to scrape the endocervical canal and con-
`sistently retrieve an adequate sample.
`Another modification made in an attempt to collect
`endocervical cells is what is called a “cytology brus .”
`This cytology brush has on the end of a long handle a
`conically-tapering brush made of spiraling bristles.
`When the brush is rotated within the endocervical ca-
`rial, cells become entrapped by the brush. However,
`while the cytology brush can consistently obtain endo-
`cervical cells, the brush is too abrasive, and so its use
`increases the incidence of bleeding and discomfort and,
`in addition, adds considerable cost to a very price-sensi-
`tive procedure.
`
`65
`
`In view of the present state of the art, it is an object
`of the present invention to provide apparatus and meth-
`ods for the simultaneous collection of cells from the
`ectocervix and the endocervix while avoiding in the
`
`8
`
`

`
`3
`process any excess bleeding or significant increases in
`procedure costs.
`It is another object of the present invention to pro-
`vide apparatus and methods for obtaining an adequate
`vaginal sample using the same device as is used for
`simultaneous collection of cells from the ectocervix and
`the endocervix.
`
`It is a further object of the present invention to pro-
`vide apparatus and methods which facilitate removal of
`cellular components from the collection areas of the
`"device onto a microscopic slide.
`It is yet a further object of the present invention to
`provide apparatus and methods which facilitate the
`removal of cellular components from the collection
`areas of the device into appropriate containers for per-
`formance of a monocellular preparation.
`It is yet another object of the present invention to
`provide apparatus and methods which reduce the po-
`tential for endocervical and cervical trauma by mechan-
`ically controlling the maximum depth of penetration of
`the device into the endocervix of the uterus, by con-
`forming to the cervical face and by maintaining align-
`ment with the endocervical canal.
`A still further object of the present invention is to
`provide apparatus and methods to maximize the collec-
`tion of cells from the endocervical canal even when said
`canal is dilated.
`
`An additional object of the present invention is to
`provide apparatus and methods to collect cells from the
`ectocervix, endocervix, and vagina that are relatively
`inexpensive and can be used widely.
`Additional objects and advantages of the invention
`will be set forth in the description which follows, and in
`part will be obvious from the description, or may be
`learned from the practice of the invention. The objects
`and advantages of the invention may be realized and
`obtained by means of the instruments and combinations
`particularly pointed out in the appended claims.
`To achieve the foregoing objects, and in accordance
`with the invention as embodied and broadly described
`herein, the present invention is directed to an apparatus
`and methods of use which permit simultaneous contact
`and collection of cells from the ectocervix and endocer-
`vix. Accordingly, the device is provided with an elon-
`gated handle having a forward end and a rear end. The
`forward end narrows slightly into a flexible zone which
`is important in the removal of cells from the device onto.
`a microscope slide. This zone allows the handle to flex
`and bring the collection areas into a position parallel to
`the slide, thereby facilitating the transfer of cellular
`material onto the microscopic slide by a direct smear
`technique.
`A member longitudinally extends from the flexible
`zone of the handle, along the same axis as the handle.
`This member is sized for comfortable insertion into the
`endocervical canal. Substantially perpendicularly pro-
`jecting from the longitudinally extending member is a
`first set of bristles. Due to their being substantially per-
`pendicular to the axis of the endocervical canal and of
`sufficient combined length to span the diameter of the
`canal, these bristles allow mildly abrasive contact with
`the walls of the endocervical canal even when the canal
`is dilated. When the canal is not dilated, these bristles
`are sufficiently supple to be easily compressed when
`entering the non-dilated cervix so as to not cause undue
`trauma to the endocervical walls.
`A second member laterally extends from the flexible
`I zone of the handle generally on opposite sides of the
`
`5
`
`l0
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`60
`
`65
`
`5,191,899
`
`4
`flexible zone from the same point where the longitudi-
`nally extending member extends from the flexible zone,
`and is positioned along an axis substantially perpendicu-
`lar to the handle of the device. Projecting forwardly
`from the laterally extending member is a second set of
`bristles.
`When the device is inserted into the uterus, the longi-
`tudinally extending member becomes inserted into the
`endocervical canal and the first set of bristles makes
`contact with the endocervical walls. Simultaneously,
`the laterally extending member is pressed against the
`cervical face with sufficient forward pressure to flex the
`second set of bristles slightly.
`To reducethe potential for sampling trauma of the
`endocervical canal from excessive penetration of the
`longitudinally extending member, the laterally extend-
`ing member will act as a mechanical barrier. The device
`can only penetrate up to the point where the laterally
`extending member presses against the cervical face. It
`will also provide a means for maintaining an axial rela-
`tionship between the device and the endocervical canal,
`thereby preventing unwanted damage to the walls of
`the canal by an off-axis insertion. The laterally extend-
`ing member may be curved so as to conform to the
`shape of the cervical face.
`Once the device is comfortably placed within the
`uterus, the device is then rotated 360 degrees. Endocer-
`vical cells and cells from the cervical face_are simulta-
`neously collected ontothe bristles of the device.
`Removal of the cells from the collection device of the
`present invention ‘may be accomplished by two meth-
`ods. The first method is by utilizing the flexible zone of
`the handle to smear the cells easily onto a microscope
`slide with a minimum of cellular material loss. Once a
`fixative is applied, the cells are ready to be analyzed.
`The second method is by inserting the forward end of
`the device into a centrifuge tube filled with a fixative
`solution and spinning the device between the palms of
`two hands. The laterally extending member is designed -
`such that when the device is manually rotated, an oscil-
`lating turbulence, similar to that found in a washing
`I machine, is created which effectively releases the col-
`lected cells from the set of bristles and simultaneously
`dissolves any collected mucous into suspension. The
`solution is centrifuged and a cell pellet is produced.
`_ When this pellet is spread onto a slide, a single layer of
`cells is available for analysis.
`In one embodiment of the device, at the rear end of
`the handle, the handle may flatten into an el1iptically-
`shaped spatula which may be used to perform vaginal
`scrapings when necessary.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`In order that the manner in which the above-recited
`and other advantages and objects of the invention are
`obtained, a more particular description of the invention
`briefly described above will be_ rendered by reference to
`specific embodiments thereof which are illustrated in
`the appended drawings. Understanding that these draw-
`ings depict only typical embodiments of the invention
`and are therefore not to be considered limiting of its
`scope, the invention in its presently understood best
`mode will be described with additional specificity and
`detail through the use of the accompanying drawings in
`which:
`
`FIG. 1 is a perspective view of one embodiment of
`the present invention.
`‘
`
`9
`
`

`
`5
`FIG. 1a is an end view of the embodiment of\FIG. 1
`illustrating single plane positioning of bristles along axis
`line A—A.
`-
`‘
`
`5,19i,s99
`
`6
`Projecting perpendicularly from longitudinally ex-
`tending member 20 are means for contacting and col-
`lecting cells within the endocervical canal. In one pres-
`ently preferred embodiment of the present invention,
`the means for contacting and collecting cells within the
`endocervical canal is a first set of bristles 26 projecting
`substantially perpendicularly from the longitudinally
`extending member 20. In FIG. 1, the first set of bnishes
`26 can be seen projecting from opposing sides of the
`longitudinally extending member 20. As the first set of
`bristles 26 are perpendicular to the axis of the longitudi-
`nally extending member 20, they are also perpendicular
`to the axis of the endocervical canal 6 when the longitu-
`dinally extending member 20, they are also perpendicu-
`lar to the axis of the endocervical canal 6 when the
`longitudinally extended member 20 is inserted, and so
`provide a mildly abrasive contact with the walls of the
`endocervical canal which allows sufficient collection of
`cells. In FIG. 3, the first set of bristles 26 can be seen in
`contact with the cells of the endocervical canal.
`The size of the first set of bristles 26 are preferably of
`a length sufficient for contacting and collecting cells
`within the endocervical canal even when the endocervi-
`cal canal is dilated The desired width of each bristle is
`such that the bristles are stiff enough to provide abra-
`sive action to obtain a successful sample of cells in the
`endocervical canal, but sufficiently supple to be some-
`what easily compressed when entering an undilated
`endocervical canal, so as to prevent excess abrasion or
`damage to the walls.
`The spacing between the first set of bristles 26 is
`preferably such that bristles 26 are spaced closely
`enough to each other so that collection of the cells from
`the endocervical canal is possible, yet spaced widely
`enough from each other so that easy dislodgement of
`the cells from the first set of bristles 26, when desired, is
`accommodated. In the preferred embodiment within
`the scope of the invention, the preferred spacing is
`about 1/64".
`The preferred second bristle means within the scope
`of the present invention comprises a second member 30
`which extends laterally from the flexible zone 18, gener-
`- ally on opposite sides therefrom, from the same point
`where the longitudinally extending member 20 extends
`from the flexible zone 18. The laterally extending mem-
`ber 30 is gently curved and is positioned on an axis
`substantiallyperpendicular-to the axis of the handle 12.
`As can be seen in FIG. 3, when the device 10 is inserted
`into the uterus 9, the laterally extending member 30
`comes into contact with and rests against the cervical
`face 8 of the uterus.
`In a presently preferred embodiment of the present
`invention, the laterally extending member 30 is slightly
`curved so as to conform comfortably to the cervical
`face, thereby permitting comfortable and full contact
`between the laterally extending member 30 and the
`cervical face 8 of the uterus 9. When the laterally ex-
`tending member 30 is pushed up against the cervical
`face, the slight curve allows more of the laterally ex-
`tending member 30 to be in contact with and embrace
`the cervical face, thereby permitting a greater area of
`cell collection. It can be appreciated that
`in older
`women whose cervices have expanded, embodiments
`with less of a curve may be preferred.
`The laterally extending member 30 also acts as a
`mechanical barrier against excessive penetration of the
`endocervical canal by the longitudinally extending
`member 20. When the laterally extending member 30
`
`FIG. 2 is a cross-section taken along the line 2--2 of
`FIG. 1, illustrating the ridged shape of the handle.
`FIG. 3 is a cross-sectional view of the device of the
`present invention being inserted into the endocervical
`canal of the uterus.
`FIG. 4 is a perspective view of cells being transferred
`from the device of the present invention onto a micro-
`scope slide.
`FIG. 5 is a perspective view of cells being transferred
`from the device of the present invention into a centri-
`fuge tube.
`~
`FIG. 6 is a perspective view of a presently preferred
`embodiment of the present invention illustrating collec-
`tion of cells from the vaginal wall.
`'
`FIG. 7 is a cross-section taken along the line 7--7 of
`FIG. 6 illustrating the scraping action of the device of
`the present invention.
`FIG. 8 is a perspective view of one alternate embodi-
`ment of the device of the present invention.
`FIG. 9 is a cross-section of an alternate embodiment
`taken in the general area long the line 9--9 of FIG. 8.
`In the drawing figures, like parts have been desig-
`nated with like numerals throughout.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`Reference is first made to FIGS. 1-3 which illustrate
`one presently preferred embodiment of the invention
`and its use. The device for simultaneously contacting
`and collecting cells from the endocervical canal 6 and
`the cervical face 8 of the uterus 9 is generally designated
`at 10 and can be seen in use in FIG. 3. The device 10 is
`
`comprised of an elongated handle 12 and a tissue sam-
`pling means 11 for collecting cells. Although it can be
`appreciated that the handle 12 could be of a variety of
`lengths,
`the presently preferred length is about six
`inches. Handle 12 comprises longitudinally extending
`ridges 13 along the length of handle 12. These ridges 13
`serve to provide better grip and ease of handling of the
`device 10. The ridges 13 provide more of a non-slip
`surface than would a smooth handle on the same device
`A cross-section of the handle 12 illustrating the longitu-
`dinally extending ridges 13 can be clearly seen in FIG.
`2.
`.
`-
`«
`Handle 12 further comprises a forward end 14 and a
`rear end 16. Forward end 14 narrows into a flexible
`zone 18 of the handle 12. As will be seen later, flexible
`zone 18 is important in the deposit of cells onto micro-
`scope slides for analysis.
`Tissue sampling means 11 comprises a first bristle
`means and a second bristle means. In the preferred em-
`bodiment within the scope of the present invention, the
`first bristle means comprises a member 20 which longi-
`tudinally extends from the flexible zone 18 along the
`same axis as the axis of the handle 12. As can be seen in
`FIG. 3, when the device 10 is inserted into the uterus 9,
`the longitudinally extending member 20 becomes in-
`serted into the endocervical canal 6. (A clamp 21 is
`shown in FIG. 3 to illustrate how the vagina 22 must be
`‘ opened and held open for insertion of this or any de-
`vice.) Thus, the longitudinally extending member 20
`must be short and slim so as not to cause trauma to the
`endocervical canal. In one preferred embodiment, the
`longitudinally extending member 20 has a length of
`about 5".
`
`5
`
`10
`
`is
`
`20
`
`25
`
`30
`
`35
`
`4-0
`
`45
`
`50
`
`55
`
`65
`
`10
`
`10
`
`

`
`5,191,899
`
`7
`rests against the endocervical face 8, further penetration
`into the endocervical canal 6 by the longitudinally ex-
`tending member 20 is prohibited. The laterally extend-
`ing member 30 also provides a means for maintaining an
`axial relationship between the device 10 and the endo-
`cervical canal 6 by guiding placement of the device
`against the cervical face. Without this axial stability, the
`longitudinally extending member 21] could be inserted in
`a misaligned direction and damage to the walls of the
`endocervical canal may result.
`Projecting from the laterally extending member 30
`are a second set of bristles for contactingand collecting
`cells of the cervical face 8. In FIGS. 1 and 3, this second
`set of bristles 32 can be seen as projecting forwardly
`from said laterally extending member 30. The second
`set of bristles preferably has a length whereby they
`contact the cervical face 8 with enough abrasive action
`to collect cells, yet with enough softness so as not to
`cause damage. In one preferred embodiment, the length
`of each bristle of the second set of bristles is 3/32".
`It is important to note that the spacing of the second
`set of bristles 32 is important in the same way as de-
`scribed above for the first set of bristles 26.
`When the second set of bristles 32 are pushed up
`against the cervical face, they are preferably pushed
`with sufficient forward pressure to flex them slightly.
`At this point, the longitudinally extending member 20 is
`within the endocervical canal. The device 10 is then
`
`5
`
`10
`
`15
`
`20
`
`25
`
`35
`
`8
`the scope of the present invention, but it is preferred
`that they all lie within the same plane.
`Referring now to FIG. 4, one method of removing
`the cells from the device 10 can be seen. When the
`device 10 is removed from the uterus, the device 10
`contains endocervical and cervical face cells on the
`leading edges of the sets of bristles Because of the 360
`degree rotation, the cervical cells have basically col-
`lected only on the leading edges.
`One method of removing the cells from the device 10
`is to smear the cells onto a microscope slide 36, as can
`be seen in FIG. 4. The longitudinally extending member
`20 and the laterally extending member 30 are placed on
`the slide 36. The handle 12 is then bent upwards at the
`flexible zone 18, so that an angle between the handle 12
`and the members 20 and 32 is formed while the mem-
`bers 20 and 32 are held parallel to the slide. The user of
`the device can now easily wipe the cells off of the de-
`vice onto the slide in a parallel motion. A first smear is
`made by wiping the device 10 onto the slide 36. The
`device 10 is then rotated 180 degrees and wiped a sec-
`ond time onto the slide 36. By these two actions, the
`cells on the leading edges of each side of the bristles are
`wiped off the device and onto the slide. After a fixative
`is applied to the slide, the slide is ready for analysis.
`It is important to note that without the flexible zone
`18, it is awkward to remove the cells from the device
`onto a slide. There is less maneuverability because,
`without the flexible zone, the collecting portion cannot
`be smeared against the slide easily in a parallel motion,
`and so many of the cells are not transferred to the slide.
`In contrast, with the flexible zone 18, the longitudinally
`and laterally extending members 26 and 32 are allowed
`to be placed flat against the slide 36 and to be maneu-
`vered along the slide by the handle from a position
`above the slide and pressing downwards, rather than
`from an awkward position beside the slide, pressing
`with a sideways motion. Thus, the presence of the flexi-
`ble zone 18 facilitates removal of cells from the device
`10 with a minimum of cell material loss.
`The above-mentioned removal method illustrated _in
`FIG. 4 may result in several layers of cells being stacked
`;-on the slide. ‘As any malignant cells may be hidden at
`the bottom of the stack, this method may not always be
`sufficient. Thus, an alternative method may be used to
`create a monolayer preparation in which the cells are
`applied to the slide in a single layer. Such a method is
`also facilitated by the device of the present invention‘
`and is illustrated in FIG. 5.
`By this method, the longitudinally and laterally ex-
`tending members 26 and 32 are held in a fixative solu-
`tion in a centrifuge tube 40. The handle 12 is placed
`between the hands 41 of the user and a rubbing action
`between the two hands spins the device. Because of the
`design of the laterally extending member 30, i.e., be-
`cause it is generally perpendicular to the handle, an
`oscillating turbulence similar to that found in a washing
`machine is created by the spinning action. This action
`releases the cells from the bristles of the device into the
`fixative solution. The action also dissolves any collected
`mucous into suspension.
`.
`The cells are then spun by a centrifuge into a cell
`pellet. When this cell pellet is spread onto a slide, a
`smooth layer, one cell deep, results. Additionally, the
`cells retrieved for analysis are from both the endocervi-
`cal canal and the cervical face. As stated earlier, with
`the prior art devices, many times only one type of cell
`or the other can be retrieved from the body and tested.
`
`rotated 360 degrees. With this action, the first set of 30
`bristles 26 within the endocervical canal 6 and the sec-
`ond set of bristles 8 against the cervical face 8 rotate and
`collect cells on their leading edges. Collection of the
`endocervical cells and the cervical face cells is done
`simultaneously, and with a successful yield of cells. This
`is an improvement over the prior art devices which
`could not consistently, safely, and successfully simulta-
`neously collect endocervical and cervical face cells". As
`the process itself tends to be embarrassing and some-
`what uncomfortable, a high yield of cells from only one
`try is important, since patients may not be willing to
`come back to redo an unsuccessful test.
`It is another feature in the preferred embodiment of
`the device of the present invention to have the longitu-
`dinally extending member, the laterally extending mem-
`ber, the first and second sets of bristles, and the handle
`of the device all positioned in the same plane. This
`feature is best illustrated in FIG. 1a, wherein the first
`and second set of bristles can be seen to lie in the same
`plane along axis line A-4. With this embodiment, the
`cost of manufacture is low due to the fact that molding
`can more easily be done with a single planed object than
`with an objectwith several other dimensions. This low
`cost of manufacture encourages widespread use of the
`invention.
`'
`Additionally, having the longitudinal 20 and lateral
`30 members in the same plane as the set of bristles 32, 26
`enhances the removal of cells onto a flat surface. With
`all parts in one plane, one quick swipe of both sides of
`the device onto the slide (as pictured in FIG. 4 and later
`discussed) is all that is necessary.
`Further, with all parts in one plane there is less
`chance of causing excess abrasion and damage to the
`cervix, while at the same time, there is still successful
`"collection of cells from both the endocervical canal and
`the cervical face.
`
`45
`
`50
`
`55
`
`60
`
`65
`
`It can be appreciated that having the members, the
`handle, and the bristles in separate planes is also within
`
`11
`
`11
`
`

`
`9
`Another important advantage of the device of the
`present invention is the capability and means for scrap-
`ing and collecting cells from the vagina 22 located on
`the same device that simultaneously collects both the
`endocervical and ectocervical cells. The present inven-
`tion can also accomplish this as illustrated by the em-
`bodiment shown in FIGS. 6 and 7.
`In this embodiment,
`the rear end 16 comprises a
`spatula-shaped member 46 positioned along the same
`axis as the axis of the handle 12. The edges 48 _of the
`spatula-shaped member 46 are perpendicular to the
`faces 50 of the spatula-shaped member 46. This perpen-
`dicular shape forms a scraping surface which enables
`successful yet non-abrasive scraping of the vaginal wall
`45 and collection of the vaginal cells. The scraping
`action of perpendicular edges 48 can be clearly seen in
`the cross-section of FIG. 7.
`
`Another embodiment of the device 10 of the present
`invention which allows collection of vaginal cells is
`illustrated in FIG. 8. In this embodiment, a triangular
`shaped spatula 54 is positioned off the axis of the handle
`12 Again, as with the spatula-shaped member 46, the
`edges of triangular-shaped spatula 54 are perpendicular.
`By having the triangular-shaped spatula 54 off-axis,
`maneuverability of the device 10 is increased and col-
`lection of vaginal cells is facilitated.
`Yet another feature of an alternate embodiment of
`device 10 can be seen in FIG. 9. In FIG. 9, a cross-sec-
`tion of the laterally extending membe