CA1264135A - Endocervical sampling brush and smear method - Google Patents

Endocervical sampling brush and smear method

Info

Publication number
CA1264135A
CA1264135A CA000482657A CA482657A CA1264135A CA 1264135 A CA1264135 A CA 1264135A CA 000482657 A CA000482657 A CA 000482657A CA 482657 A CA482657 A CA 482657A CA 1264135 A CA1264135 A CA 1264135A
Authority
CA
Canada
Prior art keywords
brush
bristles
endocervical
cells
canal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000482657A
Other languages
French (fr)
Inventor
Nils Stormby
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medscand Medical AB
Original Assignee
Medscand AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medscand AB filed Critical Medscand AB
Application granted granted Critical
Publication of CA1264135A publication Critical patent/CA1264135A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0291Instruments for taking cell samples or for biopsy for uterus
    • AHUMAN NECESSITIES
    • A46BRUSHWARE
    • A46BBRUSHES
    • A46B9/00Arrangements of the bristles in the brush body
    • A46B9/02Position or arrangement of bristles in relation to surface of the brush body, e.g. inclined, in rows, in groups
    • AHUMAN NECESSITIES
    • A46BRUSHWARE
    • A46DMANUFACTURE OF BRUSHES
    • A46D1/00Bristles; Selection of materials for bristles
    • AHUMAN NECESSITIES
    • A46BRUSHWARE
    • A46BBRUSHES
    • A46B2200/00Brushes characterized by their functions, uses or applications
    • A46B2200/10For human or animal care
    • A46B2200/1066Toothbrush for cleaning the teeth or dentures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B2010/0216Sampling brushes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

ABSTRACT OF THE DISCLOSURE

Disclosed is 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 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 diameter at its widest end. The bristles are formed primarily of a nylon having a maximum 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.

Description

.` ~ 3~
1 ¦ ENDOCERVICAL S~P~,ING BRUSH AND SMEAR METHOD
2 1 BACKGROUND OF THE INYENTION
3 ¦ 1. Fie]d of the Invention:
I _ _ ______
4 The present invention relates to a method for conducting what is normally referred to as a Pap smear 6 (cytopathologic examination) on fema]es to ultimately examine 7 ce]ls in the endocervical canal for the detection of inflammato 8 pre-malignant and malignant ehanges. Although this invention 9 relates to cytological sampling, it is also excellent for cell sampling from other mucous areas as well as erosions or 11 ulcers of the skin. Also, this invention may be used for 12 microbiological sampling.
13 The invention also relates to a particular brush 14 employed in a way,~which significantly increases the cytodiag-nostic safety by an increased quantitati-~e and qualitative 16 improvement of the cell yield and therefore, increases the 17 sensitiviry of the cellular sample taken. The use of this 18 brush allows the physician to make an early diagnosis of 19 significant cytopathologic abnormalities.
2. Summar~ of the Prior Art:
_____ _______________ 21 Cellular samples for the Pap smear have been taken 22 by several means. One is the utilization of a cotton swab to 23 sample the endocervical canal. Another is the utilization 24 of a wet spatula to sample the exocervix and endocervical canal. Also, a plastic spatula is utilized. Plastic or 26 glass pipettes hav ~een used with an aspiration device. A

~ 5 1 ~ microcurette instrument has also been developed. In the use 2 of the cotton swab techniques, the difficulty encountered is 3 obtaining sufficient amounts of endocervical cells in the 4 sample for proper evaluation. The aspiration pipettes are awkward and difficult to use. The microcurettes are 6 cost-prohibitive. The wooden spatula, with or without a 7 cotton swab to samp2e the endocervical canal, is the ~ instrument presently used to obta;n a cellular samp]e for 9 ~ cytopa2hologic evaluation of t~e utrine, cervix and vagina (Pap smear). Presently, no simple and practical method has 11 been found that can provide adequate and sufficient cytological 12 epitelium material with an absence of contaminating elements 13 such as leucocytes, sperms, or talcum.
14SUMMARY OF THE_INVENTION
15The present invention is directed to a method for 16 obtaining cells from the uterine cervical canal (external 17 os) by inserting a conically tapered brush.into the canal 18 and rotating the brush to cause cells to become entrapped by 19 the brush. The brush employed utilizes a spiral wound 20bristle of 15-20 miilimeters in length and of 3 to 7 milli-21 meters in diameter at its widest enct. The bristles are 22 formed primarily of a nylon having a maximum diameter of 23 0.06 millime~ers, and relatively soft such as that of a soft 24 toothbrush to more readily bend and avoid damagin~ in the tissues.

2~ 2 J ~ 3~
It is a principar object of the present invention 2 to provide a method and an inexpensive, sirnple instrument 3 for obtaining endocervical cells in much grater quantities 4 and better quality than, for 'example, the cotton swab.
A related object of the invention is to increase 6 the nl~nber of usable smears obtained by the prior art.
7 A further related object of the invention is to 8 ¦ provide a method for gathering endocervical material which 9 ~ill be better preserved and in greater quantity than that ¦ offered by the prior art, particularly cotton swabs.
11 Yet another object of the present invention is to 12 l produce a sample from previously sampled endocer-~ix(ces) 13 ¦ with a higher sensitivity and specificity than that of a 14 cotton swab or the other physical devices employed for obtaining smears. This is possible, due to the brushing 16 action in the endocervical canal anatomy.
17 BRIEF DESORIPTION OF THE DRA~INGS
18 Further objects and advantages of the present 19 invention will become apparent as the following description proceeds, taken in conjunction with the accompanying drawings, 21 in which:
22 FIG. 1 is a partial transverse sectional view of 23 the female showing the location of the cervical channel, the 24 location of the brush for insertion an~ rotation: and FIG. 2 is a front elevation of the subject brush 26 head illustrating in detail the orientation of the bristles 27 and identifying the configura~ion.
29 ~

~26~35 1 D~SCRIPTION OF THE METHOD
2 The method of the present invention is practiced 3 as follows:
4 The patient is placed as is customary in the normal lithotomy position. As shown in FIG. 1 speculum 1 is 6 inserted into the vagina 2 and opened to Yiew the uterine 7 cervix 3. Th~ brush 4 is adYanced with the narrow end of 8 ~the conically shaped tip 5 ent~ring the endocervieal canal 6 ., 9 until a resistance is felt. The brush ~ is then turned by the operator one-half to two complete turns and then slowly 11 extracted with the mucous and cellular samples within the 12 bristles. This is immediately smeared onto a labeled glass 13 slide Dy twisting and rolling the brush with pressure onto 14 the slide. I~mediately, the smeared slide is "fixed" in alcohol or with a fixitive spray. The brush is then disposed 16 of properly. As to the brush itself, the same has the following 17 preferred dimensional characteristics:
18 Diame~er of the shaft: 2.0 millimeters 19 Len~th of the shaft: 170.0 millimeters Number of bristles: 600 21 Length of bristles: 5.4 millimeters (top) 22 7.5 millimeters (bottom) 23 Diameter of bristles: 0.06 millimeters 24 The brush is made o~ a quality nylon grade, for example DuPont (NC4109HA0025~. The plastic shaft is made of poly-26 vinylchloride of N grade l.2, and the stainless stecl of 27 ASIASUS 304, 0.65 millimetcrs.

~'~ 29 4 ~i4~3~;
1 Clin~cal_Evaluation 2 In studies made utilizing the subject brush, and 3 comparing the same to controlled tests, the following is an 4 example in which tabular results can be seen.

__ 6 Endocervical specimens came from the Section for 7 Early Diagnosis of Cancer of the First Gynecology Service of 8 the Hospital Provincial de Madrid~ as well as from the 9 Service of Gynecology (Cytological Laboratory) of the Hospital `Insalud in Alicante, and cons2sted of 276 cases tTable )1.
11 The material is gat~ered in all of the cases with 1) cotton 12 swabs wi~h a rotating movement once introduced into the 13 endocervix, and 2) the brush with a one-half to two turn 14 movement once introduced into the endoecrvix The conclusions of the study are: (l) the number 16 of usable endocervical smears with the brush is more than 17 three times larger than those done with the cotton swabs.
18 (2) The endocervical material gathered with the brush is 1'9 better preserved and of greater quantity than the one by the cot~on swab. (3) The brush gives a higher specificity than 21 the swabs, statistically significant and with a similar 22 sensitivity. (4) The routine examination of the endocervical 23 canal is insufficient when only relying on a cotton swab for 24 material collection. Therefore, the use of the brush is advisab1 e .

2 _ _ _ _ _ _ _ ___ _ _ _ 4 Method of Sampling Valuable Material Cotton Swab 112 40.58 6 Stormby's Brush 261 94.56 9 Total cases : 276 Additional reference materjal may be found in New ., Techni~ue for Cyto20~ical Sam~ With .Stormby's Brush 1 1 _ ___ __ _. _ _ ___ ____ __ _________ _____ 12 Ros,E.; Ayala, Mi. ViIplana, E.; Saiz-Pardoy F.; Lorite, L.;
13 Andrade, Mi; Narrow and Rodriguez; Esteban M.; 10th Nation~l 14 Cytology Congress, Cadiz, September 29, 30 through October 10, 1983.
16 EX~5PLE II
Frequency of complications in fifty-seven patients 17 in the use of the brush for sampling of endocervical smears 18 was also studied (see Table below).

21 Grade Pa~n _ _ _ Bleedin~
22 None 48 42 23 Slight 7 , 10 Moderate 2 4 24 Severe O
Total 57 56~

26 ~1 patient was bleeding already from the ectocervidal smear sample by ~yre's Spatula.

1 ~2~ 5 1 ¦ Further reference material may be found in Cer_ical Brush 2 ¦ For Samplin~_of En_ocervical Smear, Ahlgren, mats.; Frequency 3 of Complication, Department cf Obstetrics and Gynecology, 4 Lund University Hospital, Lund, Sweden, November 25, 1983.
5Although particular embodiments of the invention 6 have been shown and described in full here, there is no 7 intention to thereby limit the invention to the details of 8 such embodiments. On the contrary, the intention is to 9 cover ~11 modifications, alternatives, embodiments, usages and equivalents.,of the subject invention as -fall within the 11 spirit and scope of the invention, specificalion~ and the 12 appended claims.

~7 '.

29 . .

Claims (15)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A method of obtaining endocervical cellular samples for cytopathologic analysis comprising the steps of:
(a) obtaining a brush having a conical end portion with soft bristles, (b) inserting the brush into the external os of the uterine cervical canal, (c) rotating the brush one-half to two revolutions within the endocervical canal, (d) removing the brush from the patient and transferring the cells retained by the brush onto a glass slide.
2. The method of claim 1, wherein said brush is inserted into mucous membrane orifices.
3. The method of claim 1, wherein said brush is inserted onto erosions or ulcers of the skin.
4. The method of claim 1, wherein said brush is used for microbiological sampling.
5. A brush for use in connection with endo-cervical canal cell gathering comprising, in combination:
(a) an elongated shaft, (b) a brush base extending from one end of the elongated shaft and concentrically therewith for a distance of 15-20 millimeters, (c) a plurality of bristles extending laterally and in spiro-conical form from said base tapering at an angle of less than 20° from the shaft portion toward the end of the base portion, and (d) means for securing said bristles on the base portion.
6. A brush assembly for use in connection with cell sampling from the endocervical canal and for smearing the gathered cells onto a glas slide to be used in analysis by the Papanicolaou technique, comprising:
an elongated handle shaft having opposite ends;
and 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 comprises approximately 600 flexible bristles made of nylon, each of said bristles having a diameter of approximately 0.06 mm.
7. 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 attached to one end of said handle shaft concentrically 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 decreasing 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 bristles made of nylon, each of the bristles having a diameter of approximately 0.06 mm, inserting the brust 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 analyzing the glass slide thus prepared by the Papanicolaou technique.
8. 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 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 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, separating the entrapped, but by the hydrophobic properties of the flexible bristles easily detached cells from the brush, and analyzing the cells thus separated.
9. A method according to claim 8, wherein said bristles have a stiffness characterized by a tangent modulus of 630,000 ?
260,000 psi.
10. A method according to claim 8, wherein said cone-shape tapers substantially uniformly from said major diameter to said minor diameter at said distal end.
11. A method according to claim 8, wherein said hydrophobic material is nylon.
12. 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 from 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 a hydrophobic 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, separating the entrapped, but by the hydrophobic properties of the flexible bristles easily detached, cells from the brush, and analyzing the cells thus separated.
13. A method according to claim 12, wherein said bristles have a stiffness characterized by a tangent modulus of 630,000 ?
260,000 psi.
14. A method according to claim 12, wherein said cone-shaped tapers substantially uniformly from said major diameter to said minor diameter at said distal end.
15. A method according to claim 12, wherein said hydrophobic material is nylon.
CA000482657A 1984-05-29 1985-05-29 Endocervical sampling brush and smear method Expired CA1264135A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US61448784A 1984-05-29 1984-05-29
US614,487 1984-05-29

Publications (1)

Publication Number Publication Date
CA1264135A true CA1264135A (en) 1990-01-02

Family

ID=24461452

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000482657A Expired CA1264135A (en) 1984-05-29 1985-05-29 Endocervical sampling brush and smear method

Country Status (2)

Country Link
CA (1) CA1264135A (en)
GB (1) GB2159420B (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1987006114A1 (en) * 1986-04-17 1987-10-22 Anne Company Limited Apparatus for cell sampling
DE4005266A1 (en) * 1990-02-20 1991-08-22 Geka Brush Georg Karl Gmbh Scraper head for collecting cytological smears - has foamed polymer elements forming bristles or bladed surface
JP2589379Y2 (en) * 1990-05-09 1999-01-27 株式会社町田製作所 Endoscope channel and catheter cleaning brushes
JPH08501228A (en) * 1992-08-07 1996-02-13 ジェンザイム・コーポレイション Non-liquid cell sample collection method
US5713369A (en) * 1995-09-13 1998-02-03 Vance Products Inc. Uterine endometrial tissue sample brush
AU3761499A (en) 1998-04-23 1999-11-08 Cook Urological Inc. Endocervical and exocervical cell collection device
JP7303748B2 (en) 2016-12-09 2023-07-05 マラノウスカ-ステガ,ザネッタ Brush biopsy device, kit and method
EP3909538A1 (en) * 2020-05-14 2021-11-17 Syddansk Universitet A sample obtaining device

Also Published As

Publication number Publication date
GB2159420B (en) 1988-05-11
GB8513203D0 (en) 1985-06-26
GB2159420A (en) 1985-12-04

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