Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
1999-06-02
2001-02-27
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06193674
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to a brush which can be used to take a smear from the endocervical canal. In the current prior art such a smear is taken with, for example, the so-called cytobrush, put on the market by the company Medscand. The cytobrush is in the form of a woven metal wire, between which nylon hairs are woven on the front side. The nylon hairs are cut to the correct length with a blunt instrument, as a result of which there are often sharp ends on the hairs. A disadvantage of the woven metal wire is that said wire is stiff and can damage tissue if it is wrongly used.
When a smear is being taken, it is important for cells to be collected both from the outside of the cervix, the so-called ectocervical cells, and from the endocervical canal, the endocervical cells. Most abnormalities which can develop into cancer cells occur at the transition between these two areas. If the transition zone is situated far in, which is the case in, for example, older women, it is difficult to collect cell tissue from the transition zone. A specific endocervical sampler, such as the abovementioned Medscand cytobrush, is then used for this purpose.
U.S. Pat. No. 4,127,113 discloses a brush comprising an elongated handle and a brush head placed on the handle, which brush head comprises a mandrel lying in line with the handle, and brush hairs which run substantially parallel placed on the mandrel.
U.S. Pat. No. 4,759,376 discloses a brush which is in fact the same as the earlier so-called cytobrush. It is known from this document that the brush can have approximately 600 brush hairs with a thickness of approximately 0.06 mm. These brush hairs are placed in a helical pattern around the brush end of handle
4
. The nylon brush hairs are wedged between two twisted wires and thereby acquire a radial position. The distance between adjacent brush hairs then decreases from the base towards the outside.
SUMMARY OF THE INVENTION
The object of the invention is to provide a brush suitable for taking a smear from the endocervical canal which is improved relative to the brushes known in the prior art.
The brush according to the invention is characterized in that the brush hairs are provided in finely distributed rows on the mandrel in such a way that capillary channels are present between adjacent brush hairs. The brush according to the invention has the advantage that it contains no rigid or stiff parts which could cause damage to tissue if the brush is not properly used.
According to a further advantageous embodiment, at least the brush head (which comprises the mandrel and brush hairs) is in the form of a one-piece plastic injection moulded product. The chance of hairs becoming detached from the mandrel is very minimal in that case.
Finely distributed rows of brush hairs according to the invention should be understood as meaning in particular brush hairs placed with a hair density of more than 400 hairs per cm
2
. With such a high hair density, the brush is found to have a good cell-collecting action, so-called cell sampling. The cell sampling is found to be even better with a hair density of more than 600 hairs per cm
2
. The cell sampling is found to be very good when there are more than 850 hairs per cm
2
, such as more than 950 hairs per cm
2
. The brush head comprising the mandrel and hairs is also easy to manufacture according to the invention as a one-piece plastic injection moulded product with a fineness of up to in any case 1000 to 1100 hairs per cm
2
.
For good cell sampling, where on two substantially opposite longitudinal side parts the mandrel is provided with said brush hairs arranged in finely distributed rows, it has also been found advantageous for said brush hairs to run substantially parallel to each other on each longitudinal side part, transversely to the longitudinal direction of the mandrel. The term transversely should be understood in a general sense in this case as meaning at an angle which is greater than 45° relative to the longitudinal direction, more particularly at an angle which is greater than 70° relative to the longitudinal direction.
In order to permit the brush to be easily inserted into the endocervical canal even in the case of a narrow cervix, it is very advantageous according to the invention if the longitudinal faces of the mandrel situated between the opposite longitudinal side parts provided with brush hairs are free from brush hairs,in order to form an essentially flat brush head.
The brush according to the invention is preferably also provided with a stop in the transition area from the handle to the mandrel, in order to prevent the brush from being inserted too far. It is further desirable for at least the mandrel to be flexible. This makes the brush particularly suitable for use for sampling in a tilted uterus.
It has been found that the collecting action of the brush according to the invention is optimized by the specific positioning of the brush hairs as proposed by the invention.
The brush according to the invention is preferably manufactured from a single piece of flexible material, such as polyethylene. The hairs can then be designed as an integral part of the brush by being injection moulded at the same time on the mandrel. This also provides a shape for the brush and the hairs forming part of it which is repeatable and is determined by the shape of the mould, while undesirable sharp ends on the hairs are avoided.
The collecting action of the brush according to the invention can be further improved by designing it in such a way that the mandrel, viewed in cross-section, is formed as a polygon in which the mandrel has the same number of connecting flat faces running in the longitudinal direction of the mandrel as the number of angles of the polygon, and that at least one face, preferably at least two faces disposed substantially opposite each other, is provided—or are each provided—with brush hairs disposed in finely distributed rows, the brush hairs provided on one and the same face running substantially parallel to each other. Depending on the application, it is best if all faces are provided with brush hairs disposed in finely distributed rows.
In a preferred embodiment, the brush according to the invention is characterized in that the faces of the mandrel from the handle to the distal end of the mandrel are curved in such a way that the distal end of the mandrel has a cross-section measurement which is smaller than the measurement of the mandrel close to the handle. This means that the brush corresponds in the optimum manner to the shape of the particular body cavity for which the brush can be used.
The action of the capillary channels between the brush hairs is most effective if the brush hairs are all approximately the same length.
REFERENCES:
patent: 3881464 (1975-05-01), Levene
patent: 4127113 (1978-11-01), Nollan
patent: 4227537 (1980-10-01), Suciu et al.
patent: 4759376 (1988-07-01), Stormby
patent: 4762133 (1988-08-01), Bayne et al.
patent: 4873992 (1989-10-01), Bayne
patent: 5022408 (1991-06-01), Mohajer
patent: 5191899 (1993-03-01), Strickland et al.
patent: 5253652 (1993-10-01), Fast
patent: 5370128 (1994-12-01), Wainwright
patent: 5456265 (1995-10-01), Yim
patent: 5623941 (1997-04-01), Hedberg et al.
patent: 5713369 (1998-02-01), Tao et al.
patent: 5738109 (1998-04-01), Parasher
patent: 5823954 (1998-10-01), Chaffringeon
patent: 196 37 144 (1998-03-01), None
patent: 0 412 610 (1991-02-01), None
patent: 0 499 330 (1992-08-01), None
patent: 2 366 826 (1978-05-01), None
patent: 9100246 (1992-09-01), None
patent: WO 89/10724 (1989-11-01), None
Hindenburg Max
MDZ Beheer B.V.
Szmal Brian
Young & Thompson
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