SAMPLING ORDER FOR GYNECOLOGY EXAMINATIONS

Description

[0001] The present invention relates to the subject matter claimed in the general term and thus relates to the field of gynecological examinations.

[0002] Many gynecological examinations and preventive check-ups require taking swabs from the cervix (cervix uteri) or vagina and examining the material obtained in the laboratory.

[0003] Cervical cancer prevention plays a key role in preventive medicine. It is currently the most effective primary preventive measure, in which microscopically detectable precancerous lesions (dysplasia) of the cervix (cervix uteri) can be identified through cell sampling. Since the 1950s, these tests have been performed, known as Pap tests, named after the first observation described by Professor George Papanicolaou in 1928. In this cell smear, cells are taken from the woman's cervix (cervix uteri), stained, and examined microscopically. The examiner spreads the cells onto a glass slide and fixes them with an alcoholic solution. The material (cells and the accompanying mucopolysaccharide-containing mucus) can also be placed in a [various container / organ], for example.The cells are transferred to small containers filled with ethanol, isopropanol, or methanol, which fixes the cell material, prevents cell degeneration, and preserves it for further processing. Such samples can be examined not only cytologically and microscopically, but also molecularly, for example, for HPV (human papillomavirus) detection and biomarkers such as p16 and Ki-67. The different solvents must be selected to prevent the collected material from clumping and to ensure proper subsequent analysis.

[0004] The relevant examinations are now routinely carried out in large numbers.

[0005] To obtain the correct material in the largest possible quantity for the subsequent investigations, the associated so-called pre-analytical method error must be minimized, which corresponds to an increase in method sensitivity. The two determining factors here are, firstly, material from the correct location and, secondly, the quantity of material.

[0006] The anatomy of the sampling site, the cervix (cervix uteri), undergoes a lifelong macroscopic and microscopic transformation almost unique in the human body. Driven by biological reproductive forces, the cervix uteri undergoes significant changes throughout a woman's life, primarily due to the influence of the two main female hormone groups: estrogens and progestogens. Microscopically, the cervix uteri is covered by two surface cell layers (epithelia): the thicker stratified squamous epithelium and the simple columnar epithelium. The zone where these two epithelia meet and partially transform into one another through a process called metaplasia is known as the transformation zone, transition zone, or junction zone. This zone is the relevant region for cervical cancer prophylaxis. The cancerization process typically occurs there.The development of precancerous lesions (dysplasia) occurs here. Furthermore, the simple columnar epithelium, which is particularly prominent cranially to the transformation zone, is a preferred site of residence and entry for certain infectious agents due to its thin-skinned vulnerability. In girls, the transformation zone migrates from the inner part of the cervix (endocervix) to the ectocervix (ectropion) due to the influence of estrogens during puberty and adolescence. During pregnancy, it often migrates even further (ectropion of pregnancy), before shifting back into the endocervix after menopause. Additionally, the macroscopic structure and shape of the cervix undergo sometimes significant changes due to childbirth, surgeries such as cervical episiotomies, and the estrogen-deficiency-induced accelerated atrophy process (tissue aging process).

[0007] This can lead to problems in subsequent analyses of the collected samples. If the sample is taken from the wrong location, especially too far inside, there is a risk of obtaining incorrect laboratory results. Ideally, an instrument suitable for all anatomical conditions, i.e., regardless of age, would be desirable.

[0008] Regardless, the swab instrument should allow for proper material collection in virtually all situations and sample as much material as possible. Furthermore, its design should enable standardized, foolproof material collection, allowing even paramedical personnel without basic anatomical knowledge to obtain safe and valid samples.

[0009] Taking a swab is perceived as unpleasant, and occasionally even painful, in the vast majority of cases. Therefore, it is advisable to perform the sample collection in such a way that the actual procedure on the patient is brief and repetitions are unnecessary. Furthermore, as mentioned, less experienced physicians and paramedical personnel should also be enabled, after training, to obtain the necessary sample material safely and without difficulty.

[0010] Furthermore, mass sampling must be carried out using inexpensive instruments, which are exclusively disposable instruments today, as is the case here.

[0011] Papanicolaou's Pap test was originally performed using vaginal cells collected with a pipette. Subsequently, the Ayre spatula and then the development of the Cytobrush by Nils Stormby led to a significant increase in sensitivity. This brush is typically used with a speculum under direct visualization. However, it can happen that the brush is not inserted to the correct position, and inexperienced physicians, in particular, tend to insert it too far. Furthermore, the use of a spatula is necessary to obtain samples from all anatomically relevant areas.

[0012] A sampling device is already known from US Patent 3,881,464, in which a sample is obtained from the cervix that is suitable for both cytological and histological examinations. This involves obtaining a cervical sample containing tissue and cellular material by bringing the cervix into contact with a generally conical brush. The bristles of this brush are intended to be soluble in the solvent used later, but insoluble in conventional cell fixatives. The generally conical shape is achieved by having the bristles radiate radially from a shaft. At the caudal end, i.e., the end facing outwards from the patient, this shaft has a diameter of approximately 2.5 cm. The diameter decreases over a distance of approximately 2 cm to 0.5 cm with an approximately linear decrease, and cranially (towards the patient's interior) this is followed by a section approximately 1 cm long with a roughly constant diameter of 0.5 cm.

[0013] US 2009 / 0240164 A1 shows a brush for gynecological examinations intended for use in the uterus. The introduction mentions that different brushes are subject to various limitations, such as insufficient cell collection, perceived discomfort during use, and questionable insertion depth, etc.

[0014] German patent DE 699 28 281 T2 describes a smear brush. The introduction mentions cervical smearing and refers to the "Cytobrush" from the company Medscand. Its disadvantages are noted that nylon bristles are cut to the correct length with a blunt tool, resulting in sharp bristle ends, and that the wire is stiff. German patent DE 699 28 128 T2 proposes that a brush head be manufactured using injection molding; the bristle density should be between 200 and 400 bristles per square centimeter.

[0015] It is further noted that gynecological sampling instruments are also known from DE 83 20 917 U1, US 2009 / 0 062 691 A1, US 2014 / 0 083 213 A1, WO 2016 / 104 779 A1, and KR 101 504 264 B1. In particular, KR 101 504 264 B1 discloses a detachable medical brush that enables the user to insert the brush for the diagnosis of cervical precancerous lesions in order to obtain mucous material. The brush is separable from a handle and can be placed in a container. The brush has a caudally formed, cauliflower-shaped area of ​​fibers, the ends of which point cranially and slightly outwards. This calyx-like area is followed cranially by an area with bristles that extend radially outwards, are shorter than the calyx-like area, and generally taper conically towards the cranial end.The brush is formed by a pair of twisted wires between which the bristles are held. Due to their considerable length, the bristles in the proximal area give the impression of a continuous surface, which is achieved by the bristles spreading outwards from the brush axis formed by the twisted wires.

[0016] A comparable brush was also used by the inventor of the present application for a long time. However, it became apparent that the aforementioned problems, such as ease of use, reliable sampling under a wide variety of anatomical conditions, and applicability with a multitude of different laboratory techniques without requiring different sampling arrangements for different techniques, have not yet been solved in a completely satisfactory manner under all conditions.

[0017] It is therefore desirable to provide an improved sample collection procedure for gynecological examinations of the vagina or cervix, especially gynecological preventive examinations, which at least partially solves some of the aforementioned problems and nevertheless allows for inexpensive production.

[0018] The object of the present invention is to provide a novel invention for industrial application. The solution to this problem is claimed in independent form. Preferred embodiments are found in the dependent claims.

[0019] The invention thus proposes, among other things, that in a gynecological sampling instrument for vaginal or cervical examinations, which has a plurality of bristles cranially fixed to a wire arrangement extending in the axial direction, it is provided that the bristles are formed from at least 600 plastic threads with a diameter between 350 µm and 900 µm and an axial line density of at least 600 threads over a maximum axial extension of 3 cm.

[0020] A primary principle of the present invention is thus the realization that a very large number of sampling threads of sufficient density offer advantages both when used for smears and for transferring the extracted material into a liquid. This was not readily apparent. Although the comparatively thin bristles each collect only a small amount of material, and overall, despite the large number of plastic bristles, only a relatively small amount of material is obtained, the result is an exceptionally suitable sampling instrument. This is because the materials obtained during sampling can be removed from the sampling instrument very easily, indeed significantly better than in the prior art.

[0021] It can be advantageous if the bristle density is not excessively high, meaning the bristles are neither too thin nor too closely spaced. If the filaments are too thin, too little material will be collected by the corresponding bristles when standing individually. Conversely, if very thin bristles are close together, capillary effects in the spaces between the bristles become too pronounced. This can lead to the collection of different material than would be collected without capillary effects, because, firstly, the bristles adhering to each other through capillary action stiffen somewhat, and secondly, particularly fine material tends to stick to the bristles in the laboratory, resulting in a different proportion of the collected cells being analyzed. Therefore, it is preferable to limit the bristle density. If the axial extent of the bristle-bearing area is, for example, 3 cm, it is therefore preferable for the total number of filaments to remain below 1800, preferably below 1500, and particularly preferably below 1200.From this information, total thread counts for other axial extensions can be readily derived. It will be clear from the above explanation that slightly thicker threads counteract the capillary effect and that, accordingly, the maximum practical bristle density can be thickness-dependent. Furthermore, it will be clear that the practical total thread count will depend on the axial length over which bristles are intended. From the above explanations, it can be inferred that the density should not be too high.

[0022] When preparing slides for microscopy, which require a thin layer of material (monolayer) on a slide, it is advantageous that only a small amount of material is present on each of the thin bristles, as this facilitates the production of thin smears for microscopy. When transferring the material into a liquid, it is important to note that during gynecological examinations, it is generally not only the desired cells that are extracted, but these cells will also be embedded in a matrix of other material such as mucus or similar substances. For laboratory analysis, it is then necessary to remove the cells from this matrix. If solvents are required for a subsequent examination process in which the matrix material from which the cells are extracted clumps together, for example through coagulation or similar processes, obtaining the cells becomes extremely difficult.

[0023] The advantage of the invention, at least according to current knowledge, is attributed to the fact that it does not form just a few large, very compact clumps, but rather a great many small clumps in which cells, etc., are either not so strongly fixed, allowing the surface cells to be easily separated, or, due to the small size of the clumps, a smaller proportion of cells are completely enclosed within them. At the same time, the design of the brush allows for extraction from the preferred locations.

[0024] This significantly improves the overall collection of sample material with the gynecological sampling instrument. Furthermore, the use of appropriately thin threads, in contrast to hard spatulas, instruments with coarse bristles, or scrapers, considerably reduces the likelihood of causing pain or irritation during sampling. Unlike wooden and / or plastic spatulas, foam instruments, or polyethylene instruments with few, very wide "teeth," the instruments according to the invention are also structurally suitable for entering the histologically defined deep cervical crypts and obtaining the columnar epithelial cell material located there. Moreover, due to their small diameter, the bristles are still flexible enough that bleeding at the sampling site or during insertion of the sampling instrument is largely, and typically even completely, avoidable.The use of the sampling instrument is therefore much more comfortable for a patient.

[0025] This also makes the application significantly easier for the physician who has to use the gynecological sampling instrument, because they receive less negative feedback from patients. This also facilitates familiarization with the gynecological sampling instrument according to the invention, especially since it is suitable for taking samples for a variety of different examinations, thus allowing initially inexperienced physicians to gain experience more quickly.

[0026] This applies even where different brush shapes are to be used for vaginal and cervical brushes, but both, i.e., both vaginal brush and cervical brush, are to be used to collect material for different subsequent examination procedures.

[0027] It is possible and advantageous if, in a gynecological sampling instrument, the plastic threads are further and / or additionally made of polyamide. Polyamide threads are physiologically well-tolerated and inexpensive. They are available in a wide variety of diameters, are cost-effective, and, at the thicknesses specified according to the invention, offer a flexibility that is ideal for cell collection at the required locations.

[0028] It is possible to mechanically detach the plastic threads. This is possible and advantageous if, in the case of a gynecological sampling instrument, it is specifically designed so that the plastic threads can be cut, crushed, or sheared off.

[0029] It is particularly possible to cut the bristles to the length required for their respective positions within the overall brush before fixing them in the bristle body, thus reducing waste. Alternatively, trimming can be carried out by first producing a bristle body with bristles of approximately equal length and then cutting the bristles to length as required. This is currently the preferred method. In any case, the cut edges offer advantages in cell material collection because, unlike separation by laser cutting or similar methods, they can engage particularly well with the sampling point via the cut or crushed edge to collect the cells to be gathered. Nevertheless, laser cutting or similar methods could also be used.

[0030] It is possible and advantageous if, in a gynecological sampling instrument, it is further and / or additionally provided that the plastic threads have a mean diameter of at least 500 µm, preferably at least 600 µm and a maximum of 850 µm, preferably a maximum of 800 µm.

[0031] These diameters are particularly preferred for polyamide and aramid fibers because they offer sufficient stiffness to carry away a considerable amount of cellular material when the bristles are moved along the cervix or vaginal wall, while remaining flexible enough to prevent injury. It should be noted that the bristles typically protrude perpendicular to the axis immediately after manufacturing and must be straightened from this radial orientation to achieve the preferred cup shape of the outer bristles, which facilitates better sampling and visual inspection. This can be accomplished through heat treatment, but typically, it suffices to place the brushes in a narrow tube at the manufacturing site. The typical time between insertion and use is then sufficient to ensure the cup shape is achieved.

[0032] It is possible and advantageous for a gynecological sampling instrument to be further and / or additionally provided with at least 750 bristle tips over a maximum axial length of 3 cm. This bristle density does not yet lead to mutual interference between the points during sampling and simultaneously provides a sufficiently high number of sampling points. At the same time, it is preferred to use a limited number of sampling points to avoid capillary effects and the like. It may be preferred to use no more than 1800 sampling points over a 3 cm axial length, particularly preferably fewer than 1500, further preferably fewer than 1200, and especially more preferably fewer than 1100. For the sake of completeness, it should be mentioned that the number of sampling points must be reduced accordingly for shorter axial lengths.

[0033] It is possible and advantageous if, in a gynecological sampling instrument, the bristles, along with the wire assembly that secures them, are arranged as a snap-off end section on a flexible plastic rod after the examination. In a preferred embodiment, the wire assembly, which typically secures the bristles by twisting two wire elements together, is arranged on a plastic rod along with the bristles. It is particularly preferred if the end section containing the wire assembly that secures the bristles is snapped off from a flexible plastic rod of sufficient flexibility to allow the bristles to be advanced to the sampling site.A breakable end ensures that the sampling instruments can only be used single-use, because after a given examination and the subsequent breaking of the tip by manual action or similar means, they could not be reinserted into the vagina. The breakable end can be incorporated into the plastic shaft in such a way that it can be broken off by hand without tools or by snapping it off at an edge, particularly at the edge of a container intended for transport to a laboratory. The breakable end can easily be dimensioned so that breakage inside the body is not a concern, while still allowing for easy manual breakage. In this regard, it should be noted that typically during gynecological examinations, there are no objects in the way of the surgical field, so there is no significant mechanical stress on the shaft or tip.shaft are to be expected.

[0034] It is possible and advantageous for a gynecological sampling instrument to be designed so that all bristles have the same nominal diameter. This is particularly beneficial from a manufacturing perspective. Alternatively, it would also be possible to fix bundles of bristles of varying diameters using the wire or to use different thicknesses along its twists.

[0035] In one variant, the gynecological sampling instrument will be a vaginal brush. Vaginal swabs are primarily taken during tumor follow-up screening, but also preventively. The vaginal brush of the present invention is particularly suitable for this purpose. In particular, it is suitable for cytological examinations, HPV tests, and molecular biological tests. Until now, wooden spatulas or rounded plastic spatulas, which patients find rather unpleasant to use, have been employed for these purposes. In contrast, the vaginal brush proposed here, with its numerous several hundred sampling points, achieves a significant improvement in pre-analytical sensitivity and simultaneously enables swabbing even in hard-to-reach areas.The vaginal blind sac (after hysterectomy) is not uncommon, and especially in tumor follow-up after radiotherapy and particularly pronounced after so-called side-to-side colpotomy closure, it is often not spherical but frequently asymmetrical and elongated, forming "retention pockets." These pockets, however, can be easily accessed with the bristles, which is significant because local recurrences frequently originate in this area. Furthermore, cell collection can be performed gently, which is particularly advantageous given the atrophic conditions typically found in this patient group.

[0036] This vaginal brush will preferably be dimensioned and arranged for insertion into the vagina and for taking samples from the vagina. For this purpose, the vaginal brush can be designed such that the bristles form a cranially rounded brush contour, preferably with a caudal diameter away from the center of between 20 mm and 29 mm, and particularly preferably between 24 mm and 28 mm.

[0037] According to the invention, the gynecological sampling instrument is a cervical brush, wherein a cauliflower-shaped bristle area is present caudally, the bristles of which project obliquely to the central axis and extend transversely to the axis up to a maximum diameter of 28 mm, preferably 26 mm, wherein the cauliflower-shaped bristle area has an outer ring of longer bristles and at least one inner ring of bristles encompassed therein, wherein preferably the bristles of the outer bristle ring are at least so much longer than the bristles of the inner bristle ring that, during the insertion phase into the patient, at least a substantial part of the outer bristles extends axially further forward than the bristles of the inner bristle ring.Regarding the question of when the proportion of outer bristles, which terminate closer to the insertion point of the sampling instrument than the bristles of the inner ring, can be considered significant, it should be noted that the cervical brush is typically inserted under direct vision through a speculum, and the central bristle area surrounded by the bristle cup is intended to be inserted into the cervix for cell collection. During this procedure, it becomes particularly evident that the cup-forming bristles spread further and come into contact with the outer areas of the cervix. Against this background, the proportion of bristles extending far forward is considered significant, at least when it is clearly recognizable when this occurs.The preferred length of the outer bristles ensures that sample material can be obtained virtually independently of anatomy, even from locations sufficiently far from the cervical opening, while simultaneously guaranteeing excellent visual control of the insertion depth through bristle deformation. Therefore, tactile detection of bristle deformation is not necessary; instead, the deformation can be observed visually. When the brush is withdrawn after sample collection—which is achieved by rotating the brush—the cup-shaped appendage will then revert to its original form.

[0038] The preferred calyx design of a cervical brush ensures optimal cell collection, with the collection points activating at different times. Initial contact can be made with the outer bristles, and once these outer bristles have made contact, the inner bristles of the calyx-shaped area, typically closer to the cervix, will also come into contact. This brush shape not only achieves a nominally high number of contacts but also ensures that each bristle can actually collect a meaningful amount of cell material and that the bristles do not interfere with each other during collection.

[0039] The cervical brush is preferably continued cranially to the calyx-like bristle area by a short-bristle section. In the cervical brush, it is advantageous if a short-bristle section, which can be inserted up to the ectocervix, is arranged cranially to the calyx-like bristle area, with a diameter such that the diameter of the outer ring of bristles in the calyx area is at least 4 times, preferably at least 5 times, and in particular between 5.5 and 7 times larger than the diameter of the short-bristle section, wherein the short bristles generally project radially from the axis and form a helical structure with spaced-apart turns. The term "generally radial" is used here because, due to manufacturing constraints, it cannot be guaranteed that the short bristles project exactly perpendicularly from the central axis.However, it will be evident to the expert that, for example, when "twisting" the short bristles between two wire sections during the manufacture of the brush, only minor deviations will occur.

[0040] In a particularly favored variant, over 200 thread-grasping points can be formed by the bristles in the area of ​​the calyx-like bristles, for example, by over 240 bristles. These represent cervical grasping points. The specified diameters are, moreover, larger than the maximum diameter of 22 mm for an ectopy determined in morphometric studies; see the studies by Przybora LA, Plutowa A. "Histological topography of carcinoma in situ of the cervix uteri." Cancer. 1959 Mar-Apr;12(2):263-77 and Jacobson DL, Peralta L, Farmer M, Graham NM, Wright TC, Zenilman J. "Cervical ectopy and the transformation zone measured by computerized planimetry in adolescents." Int J Gynaecol Obstet. 1999 Jul;66(1):7-17.

[0041] In the calyx area, there may preferably be more than 500 thread attachment points, preferably between 500 and 700, and in particular preferably more than 550 and / or less than 600.

[0042] With the cervical brush, particularly in preferred embodiments, a specific insertion depth sufficient for the vast majority of patients can not only be achieved but also readily reproducible, allowing for particularly simple and standardized sample collection. In this way, despite the short bristles, any unpleasant sensation during insertion is avoided or at least reduced. Since the cervical brush must be inserted until contact is made with the ectocervix, excessive endocervical sampling is avoided, and the fine bristles result in cell collection that is gentle on the patient and results in minimal bleeding, which is clearly advantageous for both the patient and subsequent laboratory analyses.

[0043] The gynecological sampling instrument may also have a small plastic bead at the cranial end of the wire, specifically a drop of plastic material applied to the wire end in liquid and then hardened there. This provides protection and is also helpful when inserting the cervical brush into the rather narrow, juvenile, or age-related atrophic cervical canals. In this way, despite the short bristles, an unpleasant sensation during insertion is avoided or at least reduced. It should be noted that such a drop of plastic material is particularly advantageous for the cervical brush.

[0044] The invention will below be described only by way of example with reference to the drawing. The drawing illustrates... Fig. 1 a perspective view of a cervical brush according to the present invention; Fig. 2 the cervical brush of Fig. 1 in the side view; Fig. 3 a perspective view of a vaginal brush according to the present invention.

[0045] After Fig. 1 A gynecological sampling instrument, generally designated as 1, comprises a plurality of bristles cranially, which are fixed to a wire arrangement extending in the axial direction, wherein the bristles are formed from at least 600 plastic threads with a diameter between 350 µm and 900 µm and with an axial line density of at least 600 threads over a maximum axial extension of 3 cm.

[0046] The gynecological sampling instrument 1 is in the Figuren 1 and 2The illustrated embodiment shows a cervical brush for taking material from the area of ​​the cervix, particularly from the immediate surrounding area. The illustrated cervical brush is housed in a tube dimensioned such that the longer bristles, which initially protrude radially after production, assume the desired cup shape during transport to the physician or during storage. This is achieved by bending the longer bristles inside the tube.

[0047] In the illustrated embodiments, the plastic threads are fixed between two wire segments twisted together along the brush axis, with bristle sections being placed between the wire segments and the wires then continuously twisted together. This fixing method allows the desired high line densities to be easily achieved by adjusting the twisting tightness, pitch along the axis, density of the bristles placed between the wires, etc., and also allows the desired total number of threads or bristles of a brush according to the invention to be achieved.

[0048] In this case, the plastic threads are made of polyamide material (known under the trade name nylon).

[0049] The bristles – in this case, after being fixed in the twisted wire pieces – are cut to length such that the gynecological sampling instrument of the present invention, a cervical brush, has a brush structure with three distinct areas: from cranial to caudal, a bristle-free proximal end (i.e., the end facing the patient's interior during use), a short-bristle area for insertion into the endocervix, and a long-bristle area for taking samples from the ectocervix. This is particularly well suited in Fig. 2 This is evident. At the upper, bristle-free end, a drop of plastic material has been applied over the twisted wire pieces, among other things to protect the patient from injury by the otherwise sharp end. It should be noted that the two wire pieces may be formed along one and the same continuous, single-piece wire, which is bent back on itself at the tip.

[0050] Caudal to the tip, there is a section with approximately 240 short bristles and a clear helical structure. The bristles have a diameter between 600 µm and 800 µm and extend about 2 mm from the axial center, forming a helix with a diameter of approximately 4 mm. The clearly recognizable helical structure of the bristles, which creates axial spaces between the bristle tips, allows for easy, rotating insertion into the cervix, enabling more sensitive treatment. Furthermore, it ensures that any cellular material on the bristles remains separated, at least where mucus is only minimally collected. This also facilitates sample collection at the cervical insertion site.

[0051] Closer to the handle part of the shaft, i.e., caudal to the short-bristle area, a long-bristle area is provided. The long bristles of the long-bristle area flare out forwards from the shaft, similar to a tulip flower opening away from its stem, with the outer bristles extending further cranially forwards than the inner bristles.The desired cup shape can be achieved by twisting the nylon threads between the wire pieces to be twisted together. The bristles, cut to the appropriate length, are then embedded with the caudal (facing the physician) end of the wire pieces into a plastic rod, which allows the instrument to be grasped and inserted into the surgical site. The rod with the brush section is then placed into a transport tube with a diameter smaller than that of the inner bristles. This is done by first inserting the caudal end into the transport tube, which has a significantly smaller diameter than the length of the caudal bristles. By pushing the assembly into the tube with the shaft leading, the longer nylon threads are folded cranially. This process, typically requiring time between manufacture and transport to the physician, results in the desired cup shape.

[0052] As in Fig. 1 As can be seen, the outer calyx threads are longer than the inner ones. In the preferred embodiment, approximately 560 thread points are provided in the calyx area. In the exemplary embodiment, the threads result in a diameter of 24 mm in the inner calyx area and approximately 28 mm in the outer area. These diameters can obviously be varied without difficulty, e.g., by ±10 to 15%, although the specified diameters have proven to be quite suitable in practice.

[0053] The shaft arrangement is, as in the second embodiment which is identical in this respect, Fig. 3 The brush is visibly designed with a predetermined breaking point close to the bristle area. However, this breaking point is positioned far enough from the bristle area that sufficient space remains from the handle of the shaft to grasp the bristle end. This remaining portion of the bristle end is also sufficient for the necessary manipulation in the laboratory to remove the collected sample material from the brush. Furthermore, the shaft is dimensioned so that its caudal end remains outside the vagina, even in patients with a long vagina. Near the caudal end, the shaft can be completely rounded to facilitate unilateral or back-and-forth twisting between the thumb and forefinger.

[0054] In use, the gynecological sampling instrument is inserted under direct vision through a speculum until it reaches the pelvic cavity. Reaching the pelvic cavity, i.e., the correct insertion depth, can be easily visualized by observing the deformation of the bristles that form the calyx. This is readily apparent with the naked eye but can also be done colonoscopically. The gynecological sampling instrument is then rotated at the pelvic cavity before being withdrawn. During this process, the sample material is transferred to the bristles. The flexibility of the bristles also means that material is removed from those layers that are particularly relevant for typical examinations. It should be noted that these are very thin tissue layers.It should also be mentioned that, in addition to cervical cancer prophylaxis, in which the HPV virus plays a key causal role, the swab instrument can also be used to obtain material for other microbiological tests, such as for chlamydia, trichomonads, gonococci, herpes simplex, group A streptococci, Treponema pallidum, etc. It should be noted that sample material can be collected simultaneously from the areas of the endocervix and ectocervix that are particularly relevant for laboratory examinations, and from the especially important layer within that area, using only a single instrument. Furthermore, even untrained personnel can ensure that the correct penetration depth is maintained by observing a clearly visible deformation.

[0055] The brush can then be removed from the patient's body, and the cells can be spread onto a glass slide. If desired for subsequent tests, the tip of the brush can be broken off near the base by placing it in a transport container and snapping it back into place. After proper labeling, etc., it is transported to a laboratory where the samples are examined. If this is done by smearing the sample onto a microscopic slide, the fine distribution of the sample across the many threads results in a thin layer that is easily visible under a microscope. If, however, the sample material needs to be transferred to a solution for further (cytological or other) examinations, this is also easily accomplished.

[0056] Another embodiment is shown in Fig. 3 The gynecological sampling instrument shown there is a vaginal brush with a brush shape optimized for vaginal sampling. The vaginal brush is designed by Fig. 3 a generally conical bristle area that tapers relatively bluntly cranially, i.e. the proximal bristles still form a diameter of over 5 mm, in the illustrated embodiment even 10 mm.

[0057] This may also make the application of a plastic tip to the caudal end unnecessary. In particular, if the wire elements that clamp the bristles are formed in one piece from a continuous length of wire, which is bent back towards itself at the proximal end with a sufficiently large radius of curvature, injury to the vaginal wall is already avoided – especially in combination with the sufficiently long proximal bristles. Nevertheless, the presence of a plastic tip is typically preferred even with vaginal brushes, because the risk of injury is reduced even in the event of manufacturing defects or similar issues. It should be emphasized that it is also possible and preferred with cervical brushes to form the wire elements that clamp the bristles in one piece from a continuous length of wire, which is bent back towards itself at the proximal end with a sufficiently large radius of curvature.However, the presence of the additional plastic droplet is even more clearly preferred there due to the small bristle diameter of the proximal helix area than in the vaginal brush, which, at least in the exemplary embodiment, is shown without a plastic droplet.

[0058] The long, cranially positioned bristles of the vaginal brush prevent injury to the vaginal wall during insertion, even in the case of an inept doctor.

[0059] In the illustrated embodiment, 800 thread attachment points are provided across the entire length of the bristle area, which extends approximately 20 mm axially. These points are distributed approximately evenly around the circumference. This ensures good sample collection, similar to that achieved with a cervical brush, as well as efficient transfer of the extracted sample material for laboratory analysis in solution or onto a microscopic slide.

[0060] It should be mentioned that the manufacturing process can easily be carried out inexpensively and that, incidentally, bristles made of materials other than nylon could be used. Reference symbol list

[0061] 1 = Gynecological sampling instrument; 2 = Bristles; 2a = Bristle-free proximal end, i.e., the end facing the patient's internal organs during use; 2b = Short bristle section for insertion into the endocervix; 2c = Calyx-shaped bristle section for sampling from the ectocervix; 2c1 = Outer calyx filaments ( Fig. 2 ); 2c2 = inner calyx filaments ( Fig. 2 ) ; 3= Brush axle; 4= Drop; 5= Stem; 6= Wire pieces; 7= Break point ( Fig. 3 ).

Claims

1. Gynaecological cervical brush (1), which has a multiplicity of bristles towards the patient end, which bristles are fixed to a wire assembly that extends in an axial direction, wherein the bristles (2) are formed of at least 600 plastic filaments with a diameter of between 350 µm and 900 µm and with an axial line density of at least 600 filaments over a maximum axial extent of 3 cm, wherein further to the outside of the patient, a cup-shaped bristle region is present whose bristles (2) protrude obliquely with respect to the central axis and extend up to a diameter of 28 mm, preferably 26 mm, transversely with respect to the axis, and the cup-shaped bristle region (2c) has an outer ring (2c1) of longer bristles (2) and, enclosed by the latter, at least one inner ring of bristles (2c2), wherein the bristles of the outer bristle ring are longer than the bristles of the inner bristle ring by at least such an extent that at least a substantial part of the outer bristles extends further forwards than the bristles of the inner bristle ring.

2. Gynaecological cervical brush (1) according to the preceding claim, characterized in that the plastic filaments are produced from polyamide.

3. Gynaecological cervical brush (1) according to either of the preceding claims, characterized in that the plastic filaments are cut off or sheared off mechanically.

4. Gynaecological cervical brush (1) according to any one of the preceding claims, characterized in that the plastic filaments have an average diameter of between at least 500 µm, preferably at least 600 µm, and at most 850 µm, preferably at most 800 µm.

5. Gynaecological cervical brush (1) according to any one of the preceding claims, characterized in that at least 750 bristle ends are present over a maximum axial extent of 3 cm.

6. Gynaecological cervical brush (1) according to any one of the preceding claims, characterized in that the bristles (2), with the wire assembly fixing them, are arranged as an end region, that can be broken off after the examination, on a flexible plastic rod.

7. Gynaecological cervical brush (1) according to any one of the preceding claims, characterized in that all of the bristles (2) have the same nominal diameter.

8. Gynaecological cervical brush (1) according to the preceding claim, characterized in that a short-bristle region insertable as far as the region of the ectocervix is arranged cranially with respect to the cup-shaped bristle region, wherein the diameter of the outer bristle ring in the cup region is at least 4 times, preferably at least 5 times, in particular between 5.5 times and 7 times greater than the diameter of the short-bristle region, the short bristles generally protrude radially from the axis and the short bristles form a helix structure with windings spaced apart from one another, and / or wherein at the proximal end, the wire end is provided with a plastic protector, in particular made of a plastic material applied in the form of a liquid drop to the wire end and cured on the wire end.