United States Patent
`
`[19]
`
`[11] Patent Number:
`
`4,759,376
`
`
`
` Stormby [45] Date of Patent: Jul. 26, 1988
`
`
`
`[54] ENDOCERVICAL SAMPLING BRUSH AND
`SMEAR METHOD
`Inventor:
`Stogigbg, Stgdiongatan 65, 20074
`mo
`’ we en
`[21] Appl. No.: 38,947
`
`[76]
`
`[22] Filed:
`
`Apr. 16, 1937
`
`[63]
`
`Related U.S. Application Data
`Continuation of Ser. No. 815,766, Jan. 2, 1986, aban-
`doned, which is a continuation of Ser. No. 614,487,
`May 29,
`abandoned.
`
`Int. CL4 . ......... ........
`. .. .......... A61B 10/00
`U.S. Cl. ....................................
`_
`_
`[58] Field of Search .................. 128/756, 3041,51/slgolsi
`
`[51]
`
`[56]
`
`References Cited
`U'S_ PATENT DOCUMENTS
`128 304
`3,776,219 12/1973 Brown
`""""""""
`/
`3,881,464
`5 1975 Le
`................................ 123 756
`4,108,162
`l28;756
`s;197s chifziewigg etal. ...............
`4,127,113 11/1973 Nollan .....................
`128/756
`
`....................... .. 128/756
`4,227,537 10/1980 Suciu et al.
`
`4,395,943
`
`8/1983 Basnoli .................................. 15/206
`OTHER PUBLICATIONS
`«Mm_Rose Disposable Cytology Brushes”, 2/1979_
`Acta Obstetricia et Gynecologica Scandinavica; vol.
`XLVII, Fasc. I; “Cytological Brush Technique in Ma-
`lignant Disease of the Endometrium” by J. E. Johnsson
`and N. G. Stormby; pp. 38-51.
`
`Primary Exam:'ner—Edward M. Coven
`A"°’”eJ” A8"~”"’ 0’ F"”"—R°Y13“°°»Ab‘amSv B°’d° 3‘
`G°°dman
`
`Disclosed is a method for obtaining cells from the ute1._
`inc cervical canal (external OS)
`a conically
`tapered brush into the canal and rotating the brush to
`cause cells to become entrapped by the brush The
`brush employed utilizes a spiral wound bristle of 15-20
`millimeters in length and of 3 to 7 millimeters in diame-
`ter at its widest end. The bristles are formed primarily
`of a nylon having a maximum diameter of 0.06 millime-
`ters, and relatively soft such as that of a soft toothbrush
`.
`.
`.
`.
`.
`‘°m°f°re3d11Yb°“da“daV°1ddamagmgmthe 1155"“-
`
`22 Claims, 1 Drawing Sheet
`
`
`
`Histologics, LLC
`
`Exhibit 1013
`
`1
`
`

`
`U.S. Patent
`
`Jul. 26, 1988
`
`4,759,376
`
`
`
`F/G. 2
`
`2
`
`

`
`1
`
`4,759,376
`
`ENDOCERVICAL SAMPLING BRUSH AND
`SMEAR METHOD
`
`This is a continuation of application Ser. No. 815,766,
`filed Jan. 2, 1986, now abandoned, which in turn is a
`continuation of application Ser. No. 614,487, filed May
`29, 1984, now abandoned.
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention:
`The present invention relates to a method for con-
`ducting what is normally referred to as a Pap smear
`(cytopathologic examination) on females to ultimately
`examine cells in the endocervical canal for the detection
`of inflammatory, pre-malignant and malignant changes.
`Although this invention relates to cytological sampling,
`it is also excellent for cell sampling from other mucous
`areas as well as erosions or ulcers of the skin. Also, this
`invention may be used for microbiological sampling.
`The invention also relates to a particular brush em-
`ployed in a way which significantly increases the cyto-
`diagnostic safety by an increased quantitative and quali-
`tative improvement of the cell yield and therefore, in-
`creases the sensitivity of the cellular sample taken. The
`use of this brush allows the physician to make an early
`diagnosis of significant cytopathologic abnormalities.
`2. Summary of the Prior Art:
`Cellular samples for the Pap smear have been taken
`by several means. One is the utilization of a cotton swab
`to sample the endocervical canal. Another is the utiliza-
`tion of a wet spatula to sample the exocervix and endo-
`cervical canal. Also, a plastic spatula is utilized. Plastic
`or glass pipettes have been used with an aspiration de-
`vice. A microcurette instrument has also been devel-
`oped. In the use of the cotton swab techniques, the
`difficulty encountered is obtaining sufficient amounts of
`endocervical cells in the sample for proper evaluation.
`The aspiration pipettes are awkward and difficult to
`use. The microcurettes are cost-prohibitive. The
`wooden spatula, with or without a cotton swab to sam-
`ple the endocervical canal, is the instrument presently
`used to obtain a cellular sample for cytopathologic
`evaluation of the utrine, cervix and vagina (Pap smear).
`Presently, no simple and practical method has been
`found that can provide adequate and sufficient cytologi-
`cal epitelium material with an absence of contaminating
`elements such as leucocytes, sperms, or talcum.
`SUMMARY OF THE INVENTION
`
`The present invention is directed to a method for
`obtaining cells from the uterine cervical canal (external
`os) by inserting a conically tapered brush into the canal
`and rotating the brush to cause cells to become en-
`trapped by the brush. The brush employed utilizes a
`spiral wound bristle of 15-20 millimeters in length and
`of 3 to 7 millimeters in diameter at its widest end. The
`bristles are formed primarily of a nylon having a maxi-
`mum diameter of 0.06 millimeters, and relatively soft
`such as that of a soft toothbrush to more readily bend
`and avoid damaging in the tissues.
`It is a principal object of the present invention to
`provide a method and an inexpensive, simple instrument
`for obtaining endocervical cells in much grater quanti-
`ties and better quality than, for example, the cotton
`swab.
`A related object of the invention is to increase the
`number of usable smears obtained by the prior art.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`A further related object of the invention is to provide
`a method for gathering endocervical material which
`will be better preserved and in greater quantity than
`that offered by the prior art, particularly cotton swabs.
`Yet another object of the present invention is to pro-
`duce a sample from previously sampled endocervix(ces)
`with a higher sensitivity and specificity than that of a
`cotton swab or the other physical devices employed for
`obtaining smears. This is possible, due to the brushing
`action in the endocervical canal anatomy.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Further objects and advantages of the present inven-
`tion will become apparent as the following description
`proceeds, taken in conjunction with the accompanying
`drawings, in which:
`FIG. 1 is a partial transverse sectional view of the
`female showing the location of the cervical channel, the
`location of the brush for insertion and rotation; and
`FIG. 2 is a front elevation of the subject brush head
`illustrating in detail the orientation of the bristles and
`identifying the configuration.
`5
`DESCRIPTION OF THE METHOD
`
`The method of the present invention is practiced as
`follows:
`
`The patient is placed as is customary in the normal
`lithotomy position. As shown in FIG. 1 speculum 1 is
`inserted into the vagina 2 and opened to view the uter-
`ine cervix 3. The brush 4 is advanced with the narrow
`end of the conically shaped tip 5 entering the endocervi-
`cal canal 6 until a resistance is felt. The brush 4 is then
`turned by the operator one-half to two complete turns
`and then slowly extracted with the mucous and cellular
`samples within the bristles. This is immediately smeared
`onto a labeled glass slide by twisting and rolling the
`brush with pressure onto the slide. Immediately, the
`smeared slide is “fixed” in alcohol or with a fixitive
`spray. The brush is then disposed of properly. As to the
`brush itself, the same has the following dimensional
`characteristics:
`
`
`2.0 millimeters
`Diameter of the shaft
`170.0 millimeters
`Length of the shaft
`600
`Number of bristles
`5.4 millimeters (top)
`Length of bristles
`7.5 millimeters (bottom)
`0.06 millimeters
`Diameter of bristles
`
`The brush is made of a quality nylon grade, for example
`DuPont (NC4l09HA0025) which is characterized by a
`tangent modulus (stiffness) of 630,000.-L-260,000 psi, a
`density of 1.067:0.005 gms/cc, and a moisture at 50%
`R.H. of about 1.4% and at 100% R.H. of about 3.0%.
`The plastic shaft is made of polyvinylchloride of N
`grade 1.2, and the stainless steel of ASIASUS 304, 0.65
`millimeters.
`
`Clinical Evaluation
`
`In studies made utilizing the subject brush, and com-
`paring the same to controlled tests, the following is an
`example in which tabular results can be seen.
`EXAMPLE I
`
`Endocervical specimens came from the Section for
`Early Diagnosis of Cancer of the First Gynecology
`Service of the Hospital Provincial de Madrid, as well as
`from the Service of Gynecology (Cytological Labora-
`
`3
`
`

`
`4,759,376
`
`4
`an elongated brush directly attached to one of said
`ends of said handle shaft concentrically with the
`shaft,
`wherein said brush extends from said one end of the
`handle shaft over a length ranging from 15 to 20
`mm, said brush is cone-shaped and decreases from
`a major diameter at said one end of the handle shaft
`ranging from 7.0 to 7.5 mm to a minor diameter
`ranging from 3.0 to 5.4 mm, and said brush com-
`prises approximately 600 flexible bristles made of
`nylon, each of said bristles having a diameter of
`approximately 0.06 mm and a stiffness character-
`ized by a tangent modulus of 630,000:260,000 psi.
`2. A method of obtaining and analyzing endocervical
`cellular samples comprising the steps of
`providing a brush assembly comprising an elongated
`handle shaft, and an elongated brush directly at-
`tached to one end of said handle shaft concentri-
`cally with the shaft, said brush extending from said
`one end of the shaft over a length ranging from 15
`to 20 mm, the brush being cone-shaped and de-
`creasing from a major diameter at said one end of
`the handle shaft ranging from 7 to 7.5 mm to a
`minor diameter ranging from 3 to 5.4 mm, and the
`brush comprising approximately 600 flexible bris-
`tles made of nylon, each of the bristles having a
`diameter of approximately 0.06 mm,
`inserting the brush into the endocervical canal until
`the lower part of the brush is just inside the canal,
`rotating the brush assembly, thereby entrapping cells
`in the interstices between the bristles,
`removing the brush from the endocervical canal,
`smearing the entrapped, but by the hydrophobic
`properties of the nylon bristles easily detached,
`cells from the brush onto a glass slide by twisting
`and rolling the brush with pressure onto the slide,
`fixing the smeared cells to the glass slide, and ana-
`lyzing the glass slide thus prepared by the Papanic-
`olaou technique.
`3. A brush assembly for use in connection with cell
`sampling from the endocervical canal and for smearing
`the gathered cells onto a glass slide to be used in cellular
`analysis for the detection of disease, the combination
`comprising:
`an elongated handle shaft having opposite ends; and
`an elongated brush attached to one of said ends of
`said handle shaft,
`wherein said brush extends from said one end of the
`handle shaft over a length ranging from approxi-
`mately l5 to 20 mm, said brush is cone-shaped and
`decreases from a major diameter at said one end of
`the handle shaft ranging from approximately 7.0 to
`7.5 mm to a minor diameter at the distal end rang-
`ing from approximately 3.0 to 5.4 mm, and said
`brush comprises approximately 600 flexible bristles
`made of nylon, each of said bristles having a diame-
`ter of approximately 0.06 mm and a stiffness char-
`acterized
`by
`a
`tangent
`modulus
`of
`630,000i260,000 psi.
`4. A brush assembly according to claim 3, wherein
`said cone-shape tapers substantially uniformly from
`said major diameter to said minor diameter at said
`distal end.
`
`5. A method of obtaining and analyzing endocervical
`cellular samples comprising the steps of
`providing a brush assembly comprising an elongated
`handle shaft, and an elongated brush attached to
`one end of said handle shaft, said brush extending
`
`3
`tory) of the Hospital Insalud in Alicante, and consisted
`of 276 cases (Table )1. The material is gathered in all of
`the cases with (1) cotton swabs with a rotating move-
`ment once introduced into the endocervix, and (2) the
`brush with a one-half to two turn movement once intro-
`duced into the endoecrvix
`The conclusions of the study are: (1) the number of
`usable endocervical smears with the brush is more than
`three times larger than those done with the cotton
`swabs. (2) The endocervical material gathered with the 10
`brush is better preserved and of greater quantity than
`the one by the cotton swab. (3) The brush gives a higher
`specificity than the swabs, statistically significant and
`with a similar sensitivity. (4) The routine examination of
`the endocervical canal is insufficient when only relying
`on a cotton swab for material collection. Therefore, the
`use of the brush is advisable.
`
`5
`
`15
`
`CYTOLOGICAL ENDOCERVICAL TECHNIQUE
`
`20
`
`
`
`%
`Valuable Material
`Method of Sampling
`40.58
`112
`Cotton Swab
`94.56
`261
`Stonnby’s Brush
`Total cases: 276
`
`25
`
`Additional reference material may be found in New
`Technique for Cytological Sampling With St0rmby’s
`Brush, Ros, E.; Ayala, Mi; Vilplana, E.; Saiz-Pardoy F.; 30
`Lorite, L.; Andrade, Mi; Narrow and Rodriguez; Este-
`ban M.; 10th National Cytology Congress, Cadiz, Sept.
`29, 30 through Oct. 10, 1983.
`
`35
`
`40
`
`45
`
`EXAMPLE II
`
`Frequency of complications in fifty-seven patients in
`the use of the brush for sampling of endocervical smears
`was also studied (see Table below).
`
`
`
`TABLE I
`Bleeding
`Pain
`Grade
`42
`48
`None
`10
`7
`Slight
`4
`2
`Moderate
`Severe
`0
`0
`Total
`57
`56*
`
`‘l patient was bleeding already from the ectocervidal smear sample by Ayre‘s
`Spatula.
`
`55
`
`Further reference material may be found in Cervical 50
`Brush For Sampling of Endocervical Smear, Ahlgren,
`mats.; Frequency of Complication, Department of Ob-
`stetrics and and Gynecology, Lund University Hospi-
`tal, Lund, Sweden, Nov. 25, 1983.
`Although particular embodiments of the invention
`have been shown and described in full here, there is no
`intention to thereby limit the invention to the details of
`such embodiments. On the contrary, the intention is to
`cover all modifications, alternatives, embodiments, us-
`ages and equivalents of the subject invention as fall 50
`within the spirit and scope of the invention, specifica-
`tion, and the appended claims.
`What is claimed is:
`1. A brush assembly for use in connection with cell
`sampling from the endocervical canal and for smearing 65
`the gathered cells onto a glass slide to be used in analysis
`by the Papanicolaou technique, comprising:
`an elongated handle shaft having opposite ends; and
`
`4
`
`

`
`4,759,376
`
`5
`from said one end of the shaft over a length ranging
`from approximately 15 to 20 mm, the brush being
`cone-shaped and decreasing from a major diameter
`at said one end of the handle shaft ranging from
`approximately 7.0 to 7.5 mm to a minor diameter at
`the distal end ranging from approximately 3.0 to
`5.4 mm, and the brush comprising approximately
`600 flexible bristles made of nylon, each of the
`bristles having a diameter of approximately 0.06
`mm,
`
`inserting the brush into the endocervical canal until
`the part adjacent the distal end of the brush is just
`inside the canal,
`rotating the brush assembly, thereby entrapping cells
`in the interstices between the bristles,
`removing the brush from the endocervical canal,
`smearing the entrapped, but by the hydrophobic
`properties of the nylon bristles easily detached,
`cells from the brush onto a glass slide by twisting
`and rolling the brush with pressure onto the slide,
`fixing the smeared cells to the glass slide, and
`analyzing the glass slide thus prepared.
`6. A method according to claim 5, wherein
`said cone-shape tapers substantially uniformly from
`said major diameter to said minor diameter at said
`distal end.
`7. A method according to claim 5, wherein
`said bristles have a stiffness characterized by a tan-
`gent modulus of 630,000i260,000 psi.
`8. A brush assembly for use in connection with cell
`sampling from the endocervical canal and for smearing
`the gathered cells onto a glass slide to be used in cellular
`analysis for the detection of disease, the combination
`comprising:
`an elongated handle shaft having opposite ends; and
`an elongated brush attached to one of said ends of
`said handle shaft,
`wherein said brush extends from said one end of the
`handle shaft over a length ranging from approxi-
`mately 15 to 20 mm, said brush is cone-shaped and
`decreases from a major diameter at said one end of
`the handle shaft which is a maximum of approxi-
`mately 7.5 mm to a minor diameter at the distal end
`which is a maximum of approximately 5.4 mm, and
`said brush comprises approximately 600 flexible
`bristles made of a hydrophobic material, each of
`said bristles having a diameter of approximately
`0.06 mm and a stiffness characterized by a tangent
`modulus of 630,000i260,000 psi.
`9. A brush assembly according to claim 8, wherein
`said cone-shape tapers substantially uniformly from
`said major diameter to said minor diameter at said
`distal end.
`10. A brush assembly according to claim 8, wherein
`said hydrophobic material is nylon.
`'
`11. A method of obtaining and analyzing endocervi-
`cal cellular samples comprising the steps of
`providing a brush assembly comprising an elongated
`handle shaft, and an elongated brush attached to
`one end of said handle shaft, said brush extending
`from said one end of the shaft over a length ranging
`from approximately 15 to 20 mm, the brush being
`cone-shaped and decreasing from a major diameter
`at said one end of the handle shaft which is a maxi-
`mum of approximately 7.5 mm to a minor diameter
`at the distal end which is a maximum of approxi-
`mately 5.4 mm, and the brush comprising approxi-
`mately 60O flexible bristles made of a hydrophobic
`
`6
`material, each of the bristles having a diameter of
`approximately 0.06 mm,
`inserting the brush into the endocervical canal until
`the part adjacent the distal end of the brush is just
`inside the canal,
`rotating the brush assembly, thereby entrapping cells
`in the interstices between the bristles,
`removing the brush from the endocervical canal,
`smearing the entrapped, but by the hydrophobic
`properties of the flexible bristles easily detached,
`cells from the brush onto a glass slide by twisting
`and rolling the brush with pressure onto the slide,
`fixing the smeared cells to the glass slide, and
`analyzing the glass slide thus prepared.
`12. A method according to claim 11, wherein
`said cone-shape tapers substantially uniformly from
`said major diameter to said minor diameter at said
`distal end.
`13. A method according to claim 11, wherein
`said hydrophobic material is nylon.
`14. A method according to claim 11, wherein
`said bristles have a stiffness characterized by a tan-
`gent modulus of 630,000-£260,000 psi.
`15. A method of obtaining and analyzing endocervi-
`cal cellular samples comprising the steps of
`providing a brush assembly comprising an elongated
`handle shaft, and an elongated brush attached to
`one end of said handle shaft, said brush extending
`from said one end of the shaft over a length ranging
`from 15 to 20 mm, the brush being cone-shaped and
`decreasing from a major diameter at said one end of
`the handle shaft ranging from 7.0 to 7.5 mm to a
`minor diameter at the distal end ranging from 3.0 to
`5.4 mm, and the brush comprising approximately
`600 flexible bristles made of a hydrophobic mate-
`rial, each of the bristles having a diameter of ap-
`proximately 0.06 mm,
`inserting the brush into the endocervical canal until
`the part adjacent the distal end of the brush is just
`inside the canal,
`rotating the brush assembly, thereby entrapping cells
`in the interstices between the bristles,
`removing the brush from the endocervical canal,
`separating the entrapped, but by the hydrophobic
`properties of the flexible bristles easily detached,
`cells from the brush, and
`analyzing the cells thus separated.
`16. A method according to claim 15, wherein
`said bristles have a stiffness characterized by a tan-
`gent modulus of 630,000-£260,000 psi.
`17. A method according to claim 15, wherein
`said cone-shape tapers substantially uniformly from
`said major diameter to said minor diameter at said
`distal end.
`18. A method according to claim 15, wherein
`said hydrophobic material is nylon.
`19. A method of obtaining and analyzing endocervi-
`cal cellular samples comprising the steps of
`providing a brush assembly comprising an elongated
`handle shaft, and an elongated brush attached to
`one end of said handle shaft, said brush extending
`from said one end of the shaft over a length ranging
`from approximately 15 to 20 mm, the brush being
`cone-shaped and decreasing from a major diameter
`at said one end of the handle shaft ranging from
`approximately 7.0 to 7.5 mm to a minor diameter at
`the distal end ranging from approximately 3.0 to
`5.4 mm, and the brush comprising approximately
`
`l0
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`5
`
`

`
`7
`
`4,759,376
`
`8
`separating the entrapped, but by the hydrophobic
`properties of the flexible bristles easily detached,
`cells from the brush, and
`analyzing the cells thus separated.
`20. A method according to claim 19, wherein
`said bristles have a stiffness characterized by a tan-
`gent modulus of 630,000i260,000 psi.
`21. A method according to claim 19, wherein
`said cone-shape tapers substantially uniformly from
`said major diameter to said minor diameter at said
`distal end.
`
`22. A method according to claim 19, wherein
`said hydrophobic material is nylon.
`II!
`it
`4!
`II!
`It
`
`600 flexible bristles made of a hydrophobic mate-
`
`rial, each of the bristles having a diameter of ap-
`
`proximately 0.06 mm.
`
`inserting the brush into the endocervical canal until
`
`the part adjacent the distal end of the brush is just
`inside the canal,
`
`rotating the brush assembly, thereby entrapping cells
`
`in the interstices between the bristles,
`
`removing the brush from the endocervical canal,
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`60
`
`65
`
`6