GB2159420A - Endocervical sampling brush and smear method - Google Patents

Abstract

Cells from the uterine cervical canal (external os) are obtained 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

SPECIFICATION Endocervical Sampling Brush and Smear Method Background of the Invention 1. Field of the Invention: The present invention relates to a method for conducting 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 employed in a way which significantly increases the cytodiagnostic safety by an increased quantitative and qualitative improvement of the cell yield and therefore, increases 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 utilization of a wet spatula to sample the exocervix and endocervical canal. Also, a plastic spatula is utilized. Plastic or glass pipettes have been used with an aspiration device. A microcurette instrument has also been developed. 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 costprohibitive. The wooden spatula, with or without a cotton swab to sample the endocervical canal, is the instrument presently used to obtain a cellular sample for cytopathologic evaluation of the uterine, cervix and vagina (Pap smear).Presently, no simple and practical method has been found that can provide adequate and sufficient cytological 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 entrapped by the brush. The brush employed utilizes a spiral wound bristle of 1520 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.

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 quantities 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.

Afurther 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 produce 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 invention 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.

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 uterine cervix 3. The brush 4 is advanced with the narrower end of the conically shaped tip 5 entering the endocervical 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: Diameter of the shaft: 2.0 millimeters Length of the shaft: 170.0 millimeters Number of bristles: 600 Length of bristles: 5.4 millimeters (top) 7.5 millimeters (bottom) Diameter of bristles: 0.06 millimeters The brush is made of a quality nylon grade, for example DuPont (NC4109HA0025). 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 comparing the same to controlled tests, the following is an example in which tabular results can be seen.

Example 1 Endocervical specimens came from the Section for Early Diagnosis of Cancer of the First Gynecology Service of the Hospital Provincal de Madrid, as well as from the Service of Gynecology (Cytological Laboratory) 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 movement once introduced into the endocervic, and 2) the brush with a one-half to two turn movement once introduced into the endocervix.

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 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.

Cytological Endocervical Technique Method of Valuable Sampling Material Cotton Swab 112 40.58 Stormby's Brush 261 94.56 Total cases: 276 Additional reference material may be found in New Technique for Cytological Sampling with Stormby's Brush. Ros, E.; Ayala, Mi; Vilplana, E.; SaizPardoy F.; Lorite, L.; Andrade, Mi; Narrow and Rodriguez; Esteban M.; 10th National Cytology Congress, Cadiz, September29, 30 through October 10,1983.

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 2 Grade Pain Bleeding None 48 42 Slight 7 10 Moderate 2 4 Severe 0 0 Total 57 56* *1 patient was bleeding already from the ectocervidal smear sample by Ayre's Spatula.

Further reference material may be found in Cervical Brush For Sampling of Endocervical Smear, Ahigren, mats.; Frequency of Complication, Department of Obstetrics and Gynecology, Lund University Hospital, Lund, Sweden, November 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, usages and equivalents of the subject invention as fall within the spirit and scope of the invention, specification, and the appended

Claims (5)

claims. CLAIMS

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 with specific characteristics mentioned above, (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 endocervical canal cell gathering comprising, in combination, (a) an elongated shaft having a diameter of 2.0 millimeters, (b) a brush base extending from one end of the elongated shaft and concentrically therewith for a distance of 1520 millimeters.

(c) a plurality of bristles extending laterally and in spiro-conical form from said base tapering at an angle of less than 200 from the shaft portion toward the end of the base portion, and (d) means for securing said bristles on the base portion.