SAMPLE REMOVAL ASSEMBLY FOR GYNECOLOGICAL EXAMINATIONS

Abstract

A gynecological cervical or vaginal sample removal instrument has, at the cranial end, a plurality of brushes that are fixed to a wire assembly extending in the axial direction. The brushes are made of at least 600 plastic filaments with a diameter between 350 μm and 900 μm and an axial line density of at least 600 filaments over a maximum axial extension of 3 cm.

Claims

1-10. (canceled)

11. A gynecological cervical or vaginal sample removal instrument comprising: a wire assembly that extends in an axial direction; and at a cranial end of the sample removal instrument, a multiplicity of bristles that are fixed to the wire assembly, wherein the bristles 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.

12. The sample removal instrument of claim 11, wherein the plastic filaments are produced from polyamide.

13. The sample removal instrument of claim 12, wherein the plastic filaments are cut off or sheared off mechanically.

14. The sample removal instrument of claim 13, wherein the plastic filaments have a mean diameter of between at least 600 μm and at most 800 μm.

15. The sample removal instrument of claim 13, wherein the plastic filaments have a mean diameter of between at least 500 μm and at most 850 μm.

16. The sample removal instrument of claim 15, wherein at least 750 bristle ends are present over a maximum axial extent of 3 cm.

17. The sample removal instrument of claim 16, wherein all of the bristles have a same nominal diameter.

18. The sample removal instrument of claim 11, wherein: the bristles, with the wire assembly to which they are fixed, are arranged as an end region of a flexible rod; and the end region can be broken off from the flexible rod after an examination.

19. A vaginal brush comprising: a wire assembly that extends in an axial direction; and at a cranial end of the vaginal brush, a multiplicity of bristles that are fixed to the wire assembly; wherein: the bristles (a) 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 and (b) are arranged and structured so that they provide the vaginal brush with a cranially rounded brush contour; and the plastic filaments are produced from polyamide, are cut off or sheared off mechanically, and have a mean diameter of between at least 500 μm and at most 850 μm.

20. The vaginal brush of claim 19, wherein the brush contour has a caudal diameter away from the center of between 20 and 29 mm.

21. The vaginal brush of claim 19, wherein the brush contour has a caudal diameter away from the center of between 24 and 28 mm.

22. A cervical brush comprising: a wire assembly that extends in an axial direction; and at a cranial end of the vaginal brush, a multiplicity of bristles that are fixed to the wire assembly; wherein: the bristles (a) 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, and (b) form a cup-shaped bristle region at a caudal end of the cervical brush; the plastic filaments are produced from polyamide, are cut off or sheared off mechanically, and have a mean diameter of between at least 500 μm and at most 850 μm; in the cup-shaped bristle region, the bristles: protrude obliquely with respect to a central axis of the cervical brush and extend up to a diameter of 28 mm transversely relative to the axis; and form at least one inner ring of bristles and an outer ring of long bristles that enclose the at least one inner ring of bristles.

23. The cervical brush of claim 22, wherein, in the cup-shaped bristle region, the bristles extend no more than up to a diameter of 26 mm transversely relative to the axis.

24. The cervical brush of claim 22, wherein the bristles of the outer ring are longer than the bristles of the inner ring by at least such an extent that at least a substantial part of the bristles of the outer ring end caudally with respect to the bristles of the inner ring.

25. The cervical brush of claim 22, wherein: a short-bristle region of short ones of the bristles that is insertable as far as a region of an ectocervix is arranged cranially with respect to the cup-shaped bristle region; the diameter of the outer ring in the cup region is at least 4 times greater than the diameter of the short-bristle region, the short ones of the bristles protrude generally radially from the axis, and the short bristles form a helix structure with windings spaced apart from one another; and/or at a proximal end of the wire assembly, a wire end is provided with a plastic protector.

26. The cervical brush of claim 25, wherein the diameter of the outer ring in the cup region is at least 5 times greater than the diameter of the short-bristle region.

27. The cervical brush of claim 25, wherein the diameter of the outer ring in the cup region is between 5.5 and 7 times greater than the diameter of the short-bristle region.

28. The cervical brush of claim 25, wherein, at the proximal end of the wire assemble, the wire end is provided with the plastic protector, and the plastic protector is made of a plastic material applied in the form of a liquid drop to the wire end and cured on the wire end.

29. A gynecological cervical sample removal brush comprising: a wire assembly that extends in an axial direction; and at a cranial end of the brush, a plurality of bristles that are fixed to the wire assembly; wherein: the bristles 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; the bristles include short bristles forming a short-bristle region; the bristles include a cup region including an outer ring of the bristles; and one or both of the following features (a) and (b): a diameter of the outer ring is at least 4 times greater than a diameter of the short-bristle region, the short bristles protrude generally radially from a central axis of the brush, and the short bristles form a helix structure with windings spaced apart from one another; and at a proximal end of the wire assembly, a plastic protector is provided on a wire end of the wire assembly.

30. The brush of claim 29, wherein the diameter of the outer ring is at least 5 times greater than the diameter of the short-bristle region.

31. The brush of claim 29, wherein the diameter of the outer ring is between 5.5 and 7 times greater than the diameter of the short-bristle region.

32. The brush of claim 29, wherein the plastic filaments are produced from polyamide.

33. The brush of claim 32, wherein the plastic filaments are cut off or sheared off mechanically.

34. The brush of claim 33, wherein the plastic filaments have a mean diameter of between at least 600 μm and at most 800 μm.

35. The brush of claim 33, wherein the plastic filaments have a mean diameter of between at least 500 μm and at most 850 μm.

36. The brush of claim 35, wherein at least 750 bristle ends are present over a maximum axial extent of 3 cm.

37. The brush of claim 36, wherein all of the bristles have a same nominal diameter.

38. The brush of claim 37, wherein: the bristles, with the wire assembly to which they are fixed, are arranged as an end region of a flexible rod; and the end region can be broken off from the flexible rod after an examination.

39. The brush of claim 38, wherein: the cup region further includes an inner ring of the bristles; the bristles of the outer ring are longer than the bristles of the inner ring by at least such an extent that at least a substantial part of the bristles of the outer ring ends caudally relative to the bristles of the inner ring.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0046] FIG. 1 shows a perspective view of a cervical brush according to an example embodiment of the present invention.

[0047] FIG. 2 shows the side view of the cervical brush from FIG. 1, according to an example embodiment of the present invention.

[0048] FIG. 3 shows a perspective view of a vaginal brush according to an example embodiment of the present invention.

DETAILED DESCRIPTION

[0049] According to FIG. 1, a gynecological sample removal assembly 1, designated overall by 1, comprises at the cranial end a multiplicity of bristles which are fixed to a wire assembly that extends in an axial direction, where the bristles 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.

[0050] In the illustrative embodiment shown in FIGS. 1 and 2, the gynecological sample removal instrument 1 is a cervical brush for removal of material from the region of the mouth of the cervix, in particular also from the outer region directly around the mouth of the cervix. The cervical brush shown can be received in a tube which is dimensioned such that the longer bristles, initially still protruding radially after production, adopt the desired cup shape during transport to the physician or during storage, for which purpose the initially still radially protruding longer bristles are bent within the tube.

[0051] In the embodiments shown, the plastic filaments are fixed between two wire segments that are twisted together along the brush axis, wherein bristle portions are brought between the wire segments and the wires are then continuously turned about each other. By virtue of this fixing, it is easily possible to obtain the desired high line densities by adapting the twisting strength, the gradient along the axis, the density of the bristles between the wires, etc., and also to achieve the desired total numbers of filaments or bristles of a brush according to the invention.

[0052] In the present case, the plastic filaments are produced from polyamide material (known by the trade name nylon).

[0053] The bristles, in the present case after they have been fixed in the twisted wire segments, are cut to length in such a way that, for the illustrated gynecological sample removal instrument of the present invention as a cervical brush, a brush structure is obtained that can be seen to have three different regions, namely, from cranial to caudal, a bristle-free proximal end, i.e., an end facing the patient interior during use, a short-bristle region for insertion into the endocervix, and a long bristle region for removing sample material from the region of the ectocervix. This can be seen particularly clearly in FIG. 2. At the upper bristle-free end, a drop of plastic material is dropped over the twisted-together wire segments, among other reasons in order to protect the patient from injuries caused by the otherwise pointed end. It will be noted in this connection that the two wire segments can be formed along one and the same continuous integral wire, which is bent back on itself at the tip.

[0054] In the caudal direction from the tip, a portion having in this case about 240 short bristles and a clear helix structure is first of all provided. The bristles have a diameter of between 600 μm and 800 μm and a length away from the axial center of about 2 mm, i.e., they form a helix with a diameter of ca. 4 mm. The clearly discernible helix structure of the bristles, which leads to axial interspaces between the bristle ends, has the effect that the brush can be easily inserted with rotation into the cervix, which permits more sensitive treatment, and moreover at the same time ensures that cell material present on the bristles remains separate, at least where there is only slight entrainment of mucus. Removal of sample material from the region of entry into the cervix is also permitted.

[0055] A long-bristle region is provided nearer the grip part of the shaft, i.e., in the caudal direction from the short-bristle region. The long bristles of the long-bristle region extend forward in a cup shape away from the shaft, like the head of a tulip, which opens out in a cup shape away from its stalk, where the outer bristles extend farther forward in the cranial direction than the inner bristles. The cup formation can be achieved when, after the nylon filaments have been twisted in between the wire segments that are to be twisted together, the bristles that are cut to the appropriate length are cast, with the caudal end of the wire segments (the end facing the physician), into a plastic rod by which the instrument can be gripped and pushed to the site, and the rod is then received with the bristle portion in a transport tube that has a diameter smaller than the diameter of the inner bristles, specifically by first pushing the caudal end into the transport tube, the latter having a diameter much smaller than the length of the caudal bristles. When the assembly is pushed, with the shaft at the front, into the tube, the longer nylon filaments are bent cranially, which results in the desired cup shape being obtained solely as a result of the time that is needed between production and transport to the physician who uses the brush.

[0056] As will be seen from FIG. 1, the outer cup filaments are longer than the inner ones. In the preferred variant, about 560 filament points are provided in the cup region. In the illustrative embodiment, the filaments provide a diameter of 24 mm in the inner cup region and of about 28 mm in the outer region. These diameters can of course be easily varied, e.g., by ±10 to 15%, although the diameters indicated have proven expedient in practice.

[0057] As can be seen from the thus far identical second illustrative embodiment in FIG. 3, the shaft assembly is formed with a predetermined breaking point close to the bristle region, although the predetermined breaking point is so far from the bristle region that, in order to break off the bristle end from the grip part of the shaft, a sufficient region still remains at which the bristle end can be grasped. This subregion remaining at the bristle end after separation is also sufficient for the manipulation that is needed in the laboratory for removing the collected sample material from the brush. The shaft is also dimensioned such that its caudal end still remains outside the vagina, even when used in patients with a long vagina. Near the caudal end, the shaft can in particular be completely round, in order to make it easier to rotate one way or back and forth between thumb and index finger.

[0058] During use, the gynecological sample removal instrument is guided to the site while viewing through a speculum. The arrival at the site, i.e., at the correct depth of insertion, can be easily detected visually by observation of the deformation of the cup-forming bristles. This is possible with the naked eye alone, although it can also be done by coloscopy. The gynecological sample removal instrument is then moved in rotation at the site, before being pulled back out again. By doing this, sample material that is to be removed gathers on the bristles. The flexibility of the bristles at the same time ensures that material is gathered from those layers that are particularly relevant for typical examinations. These are very thin tissue layers. In addition to the prevention of cervical cancer in which the HP virus has a key causal role, the smear collection instrument can also be used to collect material for other microbiological tests, for example for chlamydia, trichomoniasis, gonococci, herpes simplex, A-streptococcus, Treponema pallidum, etc. Additionally, single instrument can be used on its own to collect sample material simultaneously from the regions that are particularly relevant to the laboratory examinations, i.e., from the endocervix and ectocervix, and from the particularly significant layers there, and, what is more, untrained personnel are also able to ascertain the correct depth of insertion by simple observation of a readily visible deformation.

[0059] The brush can then be removed from the patient's body and the cells can be smeared on a glass slide. If so desired for the subsequent tests, the front end near the brush can be broken off, specifically by being introduced into a transport container and being left in the container by being buckled. After suitable labeling, etc., it can be transported to a laboratory where the collected samples are examined. If this is done by smearing the sample onto a microscope slide, the fine distribution of the collected sample on the many filaments results in a thin layer that is easy to view under a microscope. By contrast, if the sample material has to be transferred into a solution for further (cytological or other) examinations, this is likewise possible without any problems.

[0060] A further illustrative embodiment is shown in FIG. 3. The gynecological sample removal instrument shown there is a vaginal brush, which has a brush shape that is optimized for removal of vaginal sample material. For this purpose, the vaginal brush of FIG. 3 has a generally cone-shaped bristle region, which tapers to a comparatively blunt shape at the cranial end, i.e., the proximal bristles still form a diameter of over 5 mm or, in the illustrative embodiment shown, of even 10 mm.

[0061] This also dispenses with the need to apply a drop of plastic to the caudal end. Particularly if the wire elements clamping and fixing the bristles are formed in one piece from a continuous segment of wire, which is bent back on itself at the proximal end with a sufficiently large radius of curvature, specifically in combination with the still sufficiently long proximal bristles, damage to the vaginal wall is avoided. However, the presence of a drop of plastic is typically preferred also in the vaginal brush, since the risk of injury is reduced even in the case of production errors. In the case of the cervical brush too, it is possible and preferable that the wire elements clamping and fixing the bristles are formed in one piece from a continuous segment of wire, which is bent back on itself at the proximal end with a sufficiently large radius of curvature. There, however, on account of the small bristle diameters of the proximal helix region, the presence of the additional drop of plastic is more clearly preferable than in the case of the vaginal brush, which at least in the illustrative embodiment is shown without a drop of plastic.

[0062] The long bristles provided at the cranial region of the vaginal brush prevent injury to the vaginal wall during insertion, even in the hands of a clumsy physician.

[0063] Over the total range of the bristle region, which extends axially by about 20 mm, there are 800 filament attachment points in the illustrative embodiment shown, these being distributed more or less uniformly about the circumference. Efficient removal of sample material is thus achieved, similarly to the case of the cervical brush, and also efficient deposition of the removed sample material into solution or onto a microscope slide for examination in a laboratory is achieved.

[0064] It will be noted that the instrument can readily be produced in a cost-effective manner and also that bristles made of a material other than nylon can be used.

LIST OF REFERENCE SIGNS

[0065] 1 gynecological sample removal instrument [0066] 2 bristles [0067] 2a bristle-free proximal end, i.e., the end facing the patient interior during use [0068] 2b short-bristle region for insertion into the endocervix [0069] 2c cup-shaped bristle region for sample removal from the region of the ectocervix [0070] 2c1 outer cup filaments (FIG. 2) [0071] 2c2 inner cup filaments (FIG. 2) [0072] 3 brush axis [0073] 4 drop [0074] 5 stem [0075] 6 wire segments [0076] 7 predetermined breaking point (FIG. 3)