WO2019101870A1

WO2019101870A1 - Device and kits for sampling cervical-vaginal cells in women

Info

Publication number: WO2019101870A1
Application number: PCT/EP2018/082244
Authority: WO
Inventors: Jean-Luc DE MARIN DE MONTMARIN; Fanny MARILLER; Bertrand GOUBET
Original assignee: De Marin De Montmarin Jean Luc; Mariller Fanny; Goubet Bertrand
Priority date: 2017-11-22
Filing date: 2018-11-22
Publication date: 2019-05-31
Also published as: FR3073726A1; FR3073726B1

Abstract

This device (10) comprises a brush (100), consisting of flexible filaments (101) suitable for sampling cells, by friction, from the cervix (C) of the uterus (U) and top of the vagina (V), and a support (110) for the brush, which has an elongate shape following a proximodistal axis (X-X) and which is suitable for being introduced into the vagina of the patient along this axis, the filaments of the brush being borne by a distal end of the support, and a withdrawal thread (120; 120'; 120'') secured to the support. The support is shaped in order to be both introduced in its entirety into the vagina of the patient until the device is entirely received in the vagina apart from a free end (120A) of the withdrawal thread which is intended to hang outside the vagina through the vulva (VU) of the patient and, when the support is thus entirely accommodated in the vagina of the patient, to interact by contact with the vaginal passage in such a way as, without direct manipulation of the device by the patient and before the patient withdraws the device from the inside the vagina by pulling on the withdrawal thread in the proximal direction, to hold the support in place inside the vagina with the brush applied and rubbing against the cervix of the uterus and the top of the vagina. This device is effective and inexpensive to produce, while being easy to use, in particular by making it possible to perform a reliable self-sampling smear.

Description

Device and kits for collecting cervico-vaginal cells in women

The present invention relates to a device and kits for collecting cervico-vaginal cells in women. This device and these kits are especially intended for detecting cervical cancer and for detecting infectious pathologies of the vagina.

Cervical cancer is currently one of the most common cancers in women. In France, an average of 2,800 new cases are diagnosed each year, leading to 1,100 deaths. Worldwide, an average of 530,000 new cases are diagnosed each year, resulting in 266,000 deaths. In the vast majority of cases, cervical cancer is caused by human papillomaviruses, infecting the mucous membranes of the cervix and vagina. These papillomaviruses in fact cause precancerous lesions, that is to say, changes in the cells of the epithelium of the cervix and the vagina. In order to detect the presence of these human papillomaviruses and, more generally, agents responsible for infectious diseases of the vagina, and thus to be able to initiate as soon as possible appropriate treatment of these agents, regular gynecological monitoring is recommended.

In the course of such a gynecological follow-up, cervico-vaginal smears are performed at regular intervals in the woman: each smear makes it possible to take cells from the cervix of her uterus and from the base of her vagina, the removed cells then being subjected to biological and / or pathological examinations for screening purposes. To protect the entire population of women, such a screening process must be carried out en masse, which poses practical problems and entails substantial costs.

In fact, the collection of cells from the cervix and the vaginal bottom is currently carried out in a doctor's office, by a doctor, particularly a gynecologist, which may already represent certain constraints for the patients, in connection with the modalities and appointment times. Moreover, this sampling is carried out using specific tools: a "sampling" part of these tools, which is used to collect the cells of the patient by friction and which is generally in the form of a brush or of a spatula, is carried by the distal end of a long fine handle, handled by the doctor. Thus, during the sampling operation, the doctor holds with one hand the proximal portion of the handle of the tool and introduces the distal portion of the handle inside the vagina of the patient, if necessary using her other. hand to facilitate access to the vagina through the vulva of the patient. The introduction of the distal part of The handle of the tool inside the vagina should be deep enough to rub the brush or spatula, provided at the distal end of the handle, against the bottom of the vagina and the cervix. In addition, to collect a significant amount of cells, the doctor must then gently move the tool so that the brush or spatula "sweeps" the bottom of the vagina and the cervix: usually, the doctor turns the tool several times on himself, always by manipulating him by the proximal part of his sleeve. The tool can then be removed from the vagina: usually after being separated from the handle, the brush or spatula is placed in a sealed container, sent, if necessary by post, to an anatomopathological analysis laboratory. Even if they are performed with dexterity, the gestures of using the current sampling tools take time for the practitioner and can be a source of discomfort or pain for the patient. Moreover, once the results of anatomopathological analysis are available, the patient is forced to make another appointment to consult her doctor and have the interpretation of these results. The implementation of these current sampling devices is therefore not satisfactory.

A remedy for this problem has been envisaged in WO 2009/018607, US Pat. No. 6,402,700, US Pat. No. 6,352,513 and US 2014/073989, in the form of "self-lifting" devices, that is devices that the patient manipulates herself to perform a vaginal swab. All these self-harvesting devices are designed to be introduced only partially into the vagina of a patient, while the rest of the device remains outside the vagina so that the patient can hold it with one hand. In WO 2009/018607, US 6 402 700 and US 2014/073989, as well as for the embodiment of FIGS. 1 to 10 of US Pat. No. 6,352,513, the part of these sampling devices, intended to always remain outside vagina, is typically in the form of a handle or a handle, which allow the patient, on the one hand, to hold and train, from outside her vagina, the device so that the part of the latter, introduced into her vagina, is forced to rub against the vaginal walls and thus take cells, and then remove the device from her vagina. For the embodiment of FIGS. 11 to 13 of US 6,352,513, the portion of the sampling device, intended to always remain outside the vagina, corresponds to the distal end portion of a foam body, surrounded by an external gripping ring, which is held in place by a first hand of the patient just at the exit of her vagina and by the inside of which the foam body has to be passed by the patient by pulling, by her second hand, on a contraction wire attached to a rigid disk which is placed at the distal end of the foam body and on which is mounted a sampling sponge. In all cases, the manipulation of placement, wearing and withdrawal of these self-harvesting devices are difficult to implement for the patient because she is not accustomed to appropriate surgical procedures. These self-harvesting devices may in particular be insufficiently depressed into the vagina or be removed before cells of the cervix and vaginal bottom are removed from the device with a satisfactory quality and / or quantity.

It will be appreciated that the cell harvesting devices heretofore contemplated, including the device of the invention, should not be confused with devices for collecting fluids or body fluids, where appropriate vaginal fluids or liquids. US 5,823,954, US 4,257,427 and US 5,840,055 provide devices of this type, in which filiform elements or a wick are provided for transferring, by absorption and / or capillary action, the fluids and liquids present in the cavity. vaginal, up to either the outside of the device, or in an internal reservoir of the device. The structure and / or the material of these filiform elements or this wick prohibit them from being able to take cells by friction. In addition, these devices are dimensioned so that these filiform elements or this wick come into contact with the side wall of the vagina, and not the bottom of the latter, in order to effectively collect the fluids and liquids present in the vaginal cavity.

The object of the present invention is to propose a new device for collecting cervico-vaginal cells, which, while being both efficient and inexpensive to manufacture, is particularly reliable and easy to use, in particular by making it possible to overcome implementation constraints mentioned above.

For this purpose, the subject of the invention is a device for collecting cervico-vaginal cells from women, in particular for the detection of cervical cancer and infectious diseases of the vagina, this device being as defined in the claim 1.

One of the basic ideas of the invention is to propose an intravaginal device allowing cell removal in a simple and effective manner, that is to say a device that is designed to be handled reliably directly by the device. woman to have a swab, without the intervention of a health professional. To do this, the device according to the invention incorporates a friction sampling brush, carried by an elongated support which, in its longitudinal direction, is short enough to be housed entirely within the vagina and which, according to its other dimensions, is intended to be held in place inside the vagina, by contact with the conduit that forms the vagina, so that the brush is applied against the bottom of the vagina and the cervix. The device can thus be received in the vagina in all except a free end of a thread, or flexible strand that hangs outside the vagina through the vulva of the patient. Once thus set up by the woman inside her vagina, the device according to the invention is kept by the woman for a period of one or a few minutes, during which the woman can, if necessary, continue routine activities: by small relative movements, the brush rubs the bottom of the vagina and the cervix by detaching cells from the filaments of the brush, without the need for the patient to manipulate directly the device for this purpose. At the end of the aforementioned period of time, the woman removes the device from her vagina by pulling proximally on the free end of the aforementioned wire so as to extract the entire device of her vagina with a gesture. Then, the woman places, at least temporarily, the device in a receiver bottle so that the cells taken from the filaments of the brush are screened for pathogenic infectious agents, in particular human papillomaviruses: this screening can be carried out either by biological and / or pathological analysis, after the vial, the inside of which is either left dry or filled with a preservative liquid, has been sent, if necessary by post, to a laboratory ad hoc, or by biochemical reactions operated directly in the vial as the latter contains an ad hoc reactive liquid, such reactions may for example be of the PCR type (acronym for the English expression "Polymerase Chain Reaction"). can be expressed by polymerase chain reaction or polymerase chain reaction).

The autoprélèvement that allows the device according to the invention releases consulting time for doctors, including gynecologists, and allows patients to consult their doctor directly with the results of screening obtained through the use of the device complies with the invention. This self-collection is not detrimental to the efficiency of the collection of cells of the cervix and the vaginal bottom: on the contrary, the quality of the samples is remarkable, in particular thanks to the appropriate conformation of the support and, advantageously, to a certain shape. Special brush, similar to the shape of a badger, as explained in more detail later.

In practice, for the patient, the establishment, wearing and removal of the device of the invention, vis-à-vis her vagina is similar in terms of sensation and manipulative gestures, those implemented with a hygienic tampon, which is particularly comfortable and reassuring. The subject of the invention is also a kit for collecting cervico-vaginal cells in women, in particular for screening for cervical cancer and infectious pathologies of the vagina, this kit being as defined in claim 12.

This kit further facilitates the introduction of the sampling device in the vagina, strengthening the comfort for the patient.

The subject of the invention is also another kit for the collection of cervico-vaginal cells in women, in particular for screening for cervical cancer and infectious diseases of the vagina, this kit being as defined in claim 14.

This kit makes it possible to implement the screening of pathogenic infectious agents, as explained above.

Additional advantageous features of cervico-vaginal cell sampling devices and kits according to the invention are specified in the other claims.

The invention will be better understood on reading the description which follows, given solely by way of example and with reference to the drawings in which:

- Figure 1 is an exploded perspective of a sampling kit according to the invention;

Figure 2 is a longitudinal section of the kit of Figure 1, shown assembled and ready for use;

FIG. 3 is an elevational view of the sampling device belonging to the kit of FIG. 1;

- Figure 4 is a section along the line IV-IV of Figure 3;

- Figure 5 is an elevational view of which the arrow V of Figure 3;

- Figure 6 is a schematic view of the vagina of a woman, within which is housed the device of Figure 3;

FIGS. 7 and 8 are views respectively similar to FIGS. 2 and 4, illustrating an alternative embodiment of the sampling device according to the invention;

- Figure 9 is a view similar to Figure 2, illustrating another alternative embodiment of the sampling device according to the invention.

FIGS. 1 and 2 show a cervico-vaginal sampling set 1. This kit 1 comprises a cervico-vaginal sampling device 10, which is shown alone in FIGS. 3 to 5 and which will be described in detail below. , as well as an inserter 20, a pusher 30 and a receiver bottle 40 which will be described in more detail below. As clearly visible in FIGS. 1 to 5, the device 10 comprises a brush 100 made up of filaments 101, as well as a member which supports the filaments 101 of the brush 100, this member forming a support 1 10.

The support 1 10 has an elongated shape along a proximal-distal axis XX, in the sense that the proximo-distal dimension, that is to say the dimension along the axis XX, of the support 1 10 is strictly greater than its two other dimensions, said transverse, respectively considered in two directions at once perpendicular to each other and extending in a geometric plane perpendicular to the axis XX. In view of its elongated shape along the X-X axis, the support 1 10 includes two longitudinal ends which are opposite to each other along the X-X axis, namely a proximal end 1 10A and a distal end 1 10B. The support 1 10 also includes a current portion 1 10C which connects the proximal ends 1 10A and distal 1 10B to each other. The brush 100 is provided at the distal end 1 10B of the support 1 10.

As explained in more detail later in the description of the use of the device 10, the support 1 10 is intended to be introduced along its proximo-distal axis XX and housed entirely within the vagina of a woman . For this purpose, the conformation of the support 1 10 is such that its total proximal-distal dimension L, that is to say the distance separating, along the axis XX, the ends 1 10A and 1 10B and including these ends, is strictly inferior to the usual anatomical depth of women's vaginas. According to a preferred dimensioning, the total proximal-distal dimension L of the support 1 10 is thus between 2 and 7 cm, preferably between 4 and 5 cm.

In addition, also as explained in more detail later in describing the use of the device 10, the support 1 10 is provided, by its shape, to stay in place inside the vagina, cooperating by contact with the conduit that forms the vagina. For this purpose, in the embodiment considered in the figures, the current part 1 10C of the support 100 defines an outer surface 1 12, which extends over the entire proximal-distal extent of the current portion 1 10C and which thus connects the proximal end 1 10A and distal end 1 10B to each other, this outer surface 1 12 being cylindrical: more specifically, the cylindrical outer surface 1 12 is centered on the axis XX and has a circular base, which is provided constant between the proximal ends 1 10A and distal 1 10B. The fact that at least the bulk of the external lateral face of the support 1 10 is shaped into a cylinder with a circular base allows the support to be globally received in a complementary manner inside the tubular duct that forms the vagina, and whatever the angular orientation of the support 1 10 about the axis XX. When the device 10 is housed inside a woman's vagina, the presence of the support 1 10 does not induce discomfort for the woman, in the sense that, externally, most of the support 1 10 marries the inner wall of the vagina. In the extension of the foregoing considerations, a preferred dimensioning for the cylindrical outer surface 1 12 is to provide that the diameter D of the latter is between 10 and 20 mm, preferably between 12 and 16 mm.

By way of variations not shown, other geometrical shapes, than the cylindrical form described above, are conceivable for the outer surface 1 12 of the support 1 10, as long as this outer surface 1 12 is shaped so as, when the support 1 10 extends in length inside the conduit that forms the vagina of a woman, cooperating by contact with this conduit to hold in place the support 1 10 inside the vagina. In particular, the outer surface 1 12 may be provided, in particular for the most part, convex, without being rigorously cylindrical with a circular base. In this case, a preferred dimensioning consists in that the total transverse dimension of the support 1 10, that is to say its maximum dimension in a geometrical plane perpendicular to the axis XX, is between 10 and 20 mm, of preferably between 12 and 16 mm.

Advantageously, the conformation of the outer surface 1 12 is extended, with a constant profile, on the proximal end 1 10A of the support 1 10: thus, as in the embodiment considered in the figures, the proximal end 1 10A defines an outer surface which is cylindrical and which is inscribed in the axial extension of the cylindrical outer surface 12A. The proximal end 1 10A of the support 1 10 thus participates in keeping the support in place inside the vagina of a woman.

At the distal end 1 10B of the support 1 10, the outer surface 1 12 is connected to an outer surface 1 14 delimited by the distal end 1 10B, this outer surface 1 14 extending across the axis proximo-distal XX, as clearly visible in Figures 3 and 4. As clearly visible in Figure 5, the connection between the outer surface 1 12 of the current portion 1 10C and the outer surface 1 14 of the distal end 1 10B is made in a contour which is provided circular and centered on the axis XX: thus, whatever the angular position of the support 1 10 around the axis XX, the junction zone between the current portion 1 10C and the end distal 1 10B of the support 1 10 has a convex outer curvature which is constant.

In addition, as can be seen in FIGS. 3 to 5, the filaments 101 of the brush 100 project protruding from the outer surface 1 14 of the distal end 1 10B of the support 1 10. These filaments 101 are flexible and are designed to take, by friction, cells of the cervix and the vagina of a woman, when using the 10. In fact, as explained in more detail later when describing the use of the device 10, the brush 100 is arranged at the cervix and the vagina of a woman when the latter carries, inside her vagina, the support 1 10: by friction between the filaments 101 and the mucous membranes of the cervix and the vaginal bottom, the filaments 101 fix on their surface surface cells released by these mucous membranes. Advantageously, as clearly visible in FIG. 5, the filaments 101 are distributed in a substantially homogeneous manner over the entire outer surface 1 14 of the distal end 1 10B: thus, whatever the angular position of the support 1 10 around the proximal-distal axis XX, the action of the brush 100 is effective.

According to an optional arrangement, making it possible in particular to improve for the patient the comfort of setting up and wearing the device 10 inside the vagina, the outer surface 1 14 is convex, or, as in the example of embodiment considered in the figures, forms a half-sphere.

According to an advantageous advantageous arrangement, which is implemented in the embodiment considered in the figures and which aims in particular to improve the collection of cells by the filaments 101, these filaments are provided for, when they are at rest, extend in length substantially parallel to the axis XX and have respective proximal-distal dimensions which vary between the filaments. More specifically, each of the filaments 101 has a proximo-distal dimension, measured from the maximum distal level of the outer surface 1 14, in this case from the distal top of the outer surface 1 14 in the embodiment considered on the Figures: the filament or filaments 101, which are located in close proximity to the proximal-distal axis XX, have a proximal-distal dimension, denoted L1 in Figure 4, which is larger than the proximal-distal dimension, denoted L2. , or the filaments, which are farthest from the axis XX. More generally, within the brush 100, the proximo-distal dimension of one of the filaments 101, located closer to the axis XX than another of the filaments, is greater than the proximal-distal dimension of this other filament. . As a result, the brush 100 generally has the shape of a badger, as clearly visible in FIG.

According to a preferred but nonlimiting dimensioning, the filaments 101 of the brush 100 have, at rest, a proximo-distal dimension of between 5 and 25 mm, preferably between 10 and 20 mm. In particular, in the case where the brush 10 has a badger shape as described above, the filaments farthest from the axis XX have a proximo-distal dimension advantageously between 5 and 15 mm, preferably equal to About 10 mm, while the most near the axis XX have a proximo-distal dimension of between 15 and 25 mm, preferably equal to about 20 mm.

In practice, especially for security reasons, the filaments 101 of the brush 100 are permanently secured to the support 1 10, being noted that a removable connection is not necessarily prohibited provided that it is safe and reliable. According to a practical and economical embodiment, which is also implemented in the example of the figures, the filaments 101 and the support 1 10 are made in one piece, for example molded. This piece may in particular be made of flexible plastic for medical use, especially polyethylene, it being understood that, by their respective structure, the filaments 101 are much more flexible than the support 1 10 within the device 10. In the extension of the considerations which precede, in particular in connection with manufacturing considerations, particularly molding, the support 1 10 may advantageously be provided hollow, as in the example of the figures, the support 1 10 then having a tubular shape, which is closed at the of the distal end 1 10B and which is open at the proximal end 1 10A, as can be seen in FIGS. 3 and 4. However, by way of variant, not shown, the support 1 10 can also be made under massive form.

The support 1 10 is, in particular at its proximal end 1 10A, secured to a withdrawal wire 120, that is to say a flexible strand for removing the support 1 10 from the inside of the vagina. a woman, by means of traction on this strand in the proximal direction. By nature, this withdrawal wire 120 is flexible and deformable, in particular compared to the support 1 10. In the embodiment considered in FIGS. 1 to 6, the wire 120 is provided in the form of a separate part of the support 1. , for example textile or plastic material, and is attached and secured to the support by being threaded into through holes 1 16 defined by the proximal end 1 10A of the support 1 10, transverse to the axis XX.

Before describing in more detail the use of the device 10, the remainder of the kit 1, namely the inserter 20, the pusher 30 and the receiving bottle 40, with reference to FIGS. 1 and 2, is described below.

The inserter 20 has a tubular shape, delimiting a through bore 21. This bore 21 is dimensioned to receive the device 10 in a complementary and coaxial manner, as shown in the configuration of the kit 1 illustrated in FIG. configuration of Figure 2, the brush 100 occupies a distal portion of the bore 21 and the support 1 10 occupies the rest of this bore 21, while the withdrawal wire 120 extends from a proximal portion of the bore to the outside of the bore through a proximal opening 21 A of the bore 21.

According to an advantageous optional arrangement, which is implemented in the exemplary embodiment considered in the figures, the inserter 20 is provided, at a distal opening 21 B of its bore 21, with flexible petals 22 which, when these petals are at rest as in Figures 1 and 2, partially seal this distal opening 21 B. In addition, on their distal face, the petals 22 each have a convex profile, so that, together, the petals 22 give the distal end of the inserter 20 a convex outer shape, intended to improve the practicality and comfort of use of the inserter 20, as explained in more detail later.

The pusher 30 is designed to be engaged and moved inside the inserter 20. More precisely, in the configuration of FIG. 2, the pusher 30 is engaged in the proximal opening 21 A of the bore 21 of the inserter 20, being arranged facing, along the axis XX, of the proximal end 1 10A of the support 1 10. In addition, by displacement of the pusher 30 along the axis XX in the distal direction, the pusher 30 is designed to interfere axially with the proximal end 1 10A of the support 1 10 so as to push the support 1 10 and, there-by, the device 10 in the distal direction, and until the device 10 outside the inserter 20 by passing this device through the distal opening 21 B of the bore 21.

The receiving bottle 40 is sized to receive at least the brush 100 of the device 10, indeed the entire device, while being able to contain a liquid 41 whose composition depends on the purpose of the receiver bottle 40, as explained below.

Other features of the kit 1 will also emerge below, in the context of the description of the use of this kit, made partially with reference to FIG.

In Figure 6 is shown, very schematically, the vagina V of a woman, with, at its entrance, the vulva VU of the woman while, at the vaginal bottom V, U uterus of the woman is partially represented, in particular with its cervix C. As is well known in anatomy, the vagina V is a musculo-mucous organ, forming a generally tubular conduit which opens outwards through the vulva VU and which, in contrast to this last, forms a cul de sac surrounding cervix C of uterus U.

In order for the woman to carry out a cervico-vaginal sampling inside her vagina V, the woman takes hold of the kit 1 in the configuration of the latter shown in FIG. 2, which thus corresponds to a configuration "ready to use ": in practice, the kit 1 is for example made available in an ad hoc package, which the woman opens to seize the kit. The woman then manipulates Kit 1 as she would with a tampon hygienic with applicator. More specifically, the woman positions the inserter 20 at the entrance to her vagina V, inserting the inserter 20 through her vulva VU, so that at least the distal opening 21 B of the inserter 20 opens inside her vagina. Then, the woman actuates the pusher 30, by manually driving it along the axis XX, in the distal direction, in other words so as to retract the pusher 30 inside the inserter 20: in this way, the pusher 30 pushes along the axis XX the device 10 out of the inserter 20 through the distal opening 21 B. The petals 22, which, in the configuration "ready to use", have facilitated the insertion of the inserter 20 at the entrance of the vagina V, interfere with the device 10 when the latter is moved by the pusher 30 towards the distal opening 21 B: by their flexibility, the petals 22 deform when the device 10 is so applied against the proximal face of the petals, under the push of the pusher 30, so that these petals 22 deviate from each other and thus let the device 10 through the distal opening 21 B.

Once the pusher 30 has been pushed fully inside the inserter 20, the device 10 is found entirely outside the inserter 20, being received inside the vagina V in full. except for a free end 120A of the withdrawal thread 120 which is left by the woman, hanging outside her vagina, through the vulva VU, as shown in FIG. 6. The support 1 10 of the device 10 is thus introduced entirely within the vagina V along the axis XX, the brush 100 is also inside the vagina V, being arranged at the bottom of the vagina and cervix C of the uterus U. The inserter 20 can then be disengaged, while the device 10 remains in place in the vagina V, the outer surface 1 12 of the support 1 10 ensuring the support to be held in place, in an efficient and comfortable way, to inside the vagina V, by contact with the duct of the vagina V, while that the free end 120A withdrawal wire 120 remains suspended outside the vagina V.

While the woman is wearing the device 10 inside her vagina, she leaves the device 10 in place for a short period of time, in particular between one and thirty minutes, in particular between one and three minutes. If so, the woman can continue her normal activities, just as she would if she wore a tampon. In any case, during the period of time mentioned above, at the level of the vaginal root V, the filaments 101 of the brush 100 rub the cervix C of the uterus U and the vaginal bottom, thus taking from the brush 100 of the cells from the cervix and the vagina. It is understood that this removal of cells by friction is achieved without the woman having to directly manipulate the device 10, especially since the latter is housed entirely within the vagina V, except for the free end 120 A thread Of course, because of the structural flexibility inherent in this withdrawal wire 120, it is not suitable, if only marginally, to be used, particularly manually solicited, to position or maintain. position the device 10 inside the vagina V or to force the brush 100 to rub the walls of the vagina by causing movement in the vagina.

At the end of the aforementioned period of time, the woman removes the device 10 from her vagina V. To do this, she pulls on the withdrawal wire 120, grasping and pulling in the proximal direction the free end 120A of the withdrawal wire she had taken care to hang out of her vagina, through the vulva VU, as shown in Figure 6. The removal of the device 10 is similar, again, the withdrawal of a hygienic tampon.

Once the device 10 is thus removed, the cells taken from the filaments 101 of its brush 100 are to be treated in order to detect infectious pathogens, in particular human papillomaviruses which, as explained in detail in the introductory part of this document, are responsible for the vast majority of cases of cervical cancer.

In practice, the treatment of the cervico-vaginal sample, recovered by the brush 100, is not limiting of the invention.

According to a first possibility, this treatment may consist of biological and / or pathological analyzes, carried out in an ad hoc laboratory to which have been sent, if necessary by mail, the cells taken by the device 10. To do this, the device 10, or at least its brush 100 if it can be separated from the support 1 10, is placed by the woman inside the receiving bottle 40 just after removing it from her vagina. Receiving bottle 40 can thus be used dry, that is to say without containing liquid, and is then akin to a protective cap. Alternatively, the receiving bottle contains the liquid 41 which then consists of a preservative liquid and the receiver bottle 40 is designed to be closed in a sealed manner during its transport to the aforementioned laboratory. In practice, it may be provided either to leave the device 10, at least its brush 100, inside the receiving bottle 40 before closing and transporting last, or to leave the receiving bottle 40 the device 10 after a predetermined duration for transferring in sufficient quantity, in the liquid 41, the sampled cells.

According to a second possibility, the liquid 41 consists of a reactive liquid whose active compound (s) will react with the pathogens present on the filaments 101 of the brush. Thus, once the brush 100 or the entire device 10 is placed by the woman inside the receiving bottle 40 where it is brought into contact with this liquid reagent, an "immediate" response as to the presence of pathogens targeted by the active compounds of the reactive liquid can be obtained. This treatment can in particular implement PCR techniques, that is to say polymerization chain amplification. In all cases, the kit thus forms a self-test for screening for cervical cancer and / or infectious diseases of the vagina.

Whatever the subsequent treatment applied to the cervico-vaginal cells taken by the device 10, it is understood that this device allows a self-sampling smear which is reliable, that is to say a smear performed effectively by the woman. -even.

Figures 7 and 8 shows a variant of the sampling device 10, which differs from the embodiment of this device, detailed so far, only by the embodiment of its withdrawal wire. Specifically, rather than providing that the withdrawal wire of the device 10 is made as a separate part of the support 1 10 and therefore to report to the latter, as for the withdrawal wire 120 described above, the device 10 Figures 7 and 8 comprises a withdrawal wire 120 'which is integral with the support 1 10. The other parts of the variant of the device 10 are the same as those described above and are therefore associated with the same reference numerals. The withdrawal wire 120 'thus forms a strand which is permanently secured to the support 1 10, by continuity of material between them.

Taking into account the considerations developed above, relating to the manufacture of the device 10, it is advantageously possible to make the filaments 101, the support 1 10 and the withdrawal wire 120 'in one piece, for example molded, made in plastic, especially polyethylene. Moreover, by providing, as in the examples shown in the figures, that the support 1 10 has a hollow tubular shape, closed at its distal end 1 10B and open at its proximal end 1 10A, the withdrawal wire 120 'extends advantageously from the inside of the support, being integral with the interior of the support. In the exemplary embodiment considered in FIGS. 7 and 8, the withdrawal wire 120 'thus extends between a free end 120', axially opposite to the support 1 10, and an end 120 'B provided both protruding from and made of material with an inner wall 1 17 of the support 1 10, which is arranged in a diametral plane of the tubular shape that the support 1 10 and which runs over substantially the entire proximal-distal extent of the support, between the ends proximal 1 10A and distal 1 10B.

In Figure 9 is shown another variant of the sampling device 10, which differs from the embodiment of Figures 7 and 8 only by the embodiment of its withdrawal wire. More specifically, rather than predicting that the withdrawal wire of the device 10 is integral with the support 1 10, as for the withdrawal wire 120 ', the device 10 of Figure 9 comprises a withdrawal wire 120 "which is formed as a separate part of the support 1 10 The other parts of this variant of the device 10 are the same as those described above and are therefore associated with the same reference numerals. The withdrawal wire 120 "thus forms a strand which is attached and secured to the support 1 10, with the specificity that this attachment is removable to allow detaching the withdrawal wire 120" of the support 1 10 when the withdrawal wire 120 "n is more useful as explained later.

By providing, as in the examples shown in the figures, that the support 1 10 has a hollow tubular shape, closed at its distal end 1 10B and open at its proximal end 1 10A, the withdrawal wire 120 "advantageously extends from the interior of the support, being removably secured to an interior of the support. In the exemplary embodiment considered in FIG. 9, the withdrawal wire 120 "has, opposite its free end 120" A, an end 120 "B which is detachably secured, in particular by complementarity of shapes, an inner surface 1 18 delimited by the distal end 1 10B. For example, the end 120 "B is tightly fitted in a recess of the surface 1 18.

Even though the withdrawal wire 120 'and the withdrawal wire 120 "have a different structure of the withdrawal wire 120, the withdrawal wires 120' and 120" are functionally similar to the withdrawal wire 120, especially when using the device 10. Indeed, the tapered conformation of the withdrawal son 120 'and 120 "relative to the support 1 10 gives these withdrawal wire 120' and 120" flexibility and deformability similar to or close to those of the withdrawal wire 120. Thus, when the support 1 10 is introduced by the patient into her vagina V to be housed in full, the device 10 is found completely received in the vagina, except the free end 120Ά, 120 "A of the wire withdrawal 120 ', 120 "which is left by the patient, hanging outside her vagina, through her vulva VU. It will furthermore be noted that, as clearly visible in FIG. 7 and in FIG. 9, the withdrawal wires 120 'and 120 "are entirely arranged inside the pusher 30 when the patient begins to manipulate the device 10, which prevents the patient from being able to use the withdrawal wires 120 'and 120 "to position the device 10 inside her vagina V. Similarly, at the end of the period of time during which the patient leaves place the device 10 inside her vagina V, the patient can remove the device from her vagina by seizing the free end 120Ά, 120 "A withdrawal wire 120 ', 120" to pull the latter in the direction proximal and thus draw the entire device 10 out of his vagina, and if the collection of cervico-vaginal cells thus produced is intended to be sent to a analysis laboratory, the withdrawal wire 120 'can be shortened by cutting or withdrawal wire 120 "can be detached from the support 1 10, to limit the total longitudinal congestion of what is sent to the laboratory.

Claims

1.- Device (10) for collecting cervico-vaginal cells in women, in particular for screening for cervical cancer and infectious diseases of the vagina,

this device comprising:

- a brush (100) made of flexible filaments (101) which are adapted to take by friction the cells of the cervix (C) of the uterus (U) and the bottom of the vagina (V) of a patient,

a support (1 10) for the brush (100), which has an elongated shape along a proximal-distal axis (XX) and which is adapted to be introduced into the vagina (V) of the patient substantially along the proximal axis; -distal, the filaments (101) of the brush (100) being carried by a distal end (1 10B) of the support, and

- a withdrawal wire (120, 120 ', 120 "), which is secured to the support (1 10),

wherein the support (1 10) is shaped for both:

- to be introduced entirely within the vagina (V) of the patient until the device (10) is received in the vagina in its entirety except for a free end (120A, 120Ά, 120 "A) of the withdrawal (120; 120 '; 120 ") which is intended to hang outside the vagina through the vulva (VII) of the patient, and

when the support is thus entirely housed in the vagina (V) of the patient, cooperate by contact with the conduit of the vagina so as to, without direct manipulation of the device by the patient and before the patient removes the device from the inside her vagina by pulling the withdrawal wire (120; 120 '; 120 ") proximally, hold the support inside the vagina with the brush (100) applied and rubbing against the cervix (C) of the uterus (U) and the bottom of the vagina.

2.- Device according to claim 1, wherein the support (1 10) has a total proximal-distal dimension (L) of between 2 and 7 cm and a total transverse dimension (D) of between 10 and 20 mm, and in wherein the filaments (101) of the brush (100) have, at rest, a proximo-distal dimension of between 5 and 25 mm.

3.- Device according to claim 1, wherein the support (1 10) has a total proximal-distal dimension (L) between 4 and 5 cm and a total transverse dimension (D) of between 12 and 16 mm, and in which the filaments (101) of the brush (100) has, at rest, a proximo-distal dimension of between 10 and 20 mm.

4.- Device according to any one of the preceding claims, wherein the proximal (1 1 OA) and distal (1 1 OB) ends of the support (1 10) are connected to each other by an outer surface ( 1 12) of the support, which is cylindrical, being substantially centered on the proximal-distal axis (XX) and having a substantially circular base which is substantially constant between the proximal and distal ends of the support.

5.- Device according to any preceding claim, wherein the distal end (1 1 OB) of the support (1 10) defines an outer surface (1 14), which extends across the proximal axis -distal (XX) and which connects to the rest of the support in a substantially circular contour which is substantially centered on the proximal-distal axis, the filaments (101) projecting from said outer surface (1 14) of the distal end (1 10B) and being substantially homogeneously distributed over the entire outer surface of the distal end.

6. A device according to claim 5, wherein the filaments (101), when at rest, extend in length substantially parallel to the proximal-distal axis (XX) and have proximal-distal dimensions. respective ones, measured from the distal maximum level of the outer surface (1 14) of the distal end (1 10B) of the support (1 10), which vary between the filaments so that the proximal-distal dimension (L1) of a first of the filaments, located closer to the proximal-distal axis than a second of the filaments, is larger than the proximal-distal dimension (L2) of the second filament.

7.- Device according to any one of the preceding claims, wherein the filaments (101) and the support (1 10) are made of a single piece of plastic.

8. Device according to any one of the preceding claims, wherein the withdrawal wire (120 ') is integral with the support (1 10).

9.- Device according to any one of claims 1 to 7, wherein the withdrawal wire (120; 120 ") is formed as a separate part of the support (1 10), which is reported and secured to the support .

10.- Device according to claim 9, wherein the withdrawal wire (120 ") is secured to the support (1 10) detachably.

1 1.- Device according to any one of the preceding claims, wherein the support (1 10) is tubular, being closed at its distal end (1 10B) and open at its proximal end (1 10A).

12.- Kit (1) for collecting cervico-vaginal cells in women, in particular for screening for cervical cancer and infectious diseases of the vagina,

this kit including:

a device (10) according to any one of the preceding claims,

- an inserter (20), which is adapted to be inserted at the entrance of the vagina (V) and which delimits a through bore (21) which receives the device (10) along the proximal-distal axis (X-X), and

- a pusher (30), which is engaged in a proximal opening (21A) of the bore (21) and which is displaceable in the bore so as to push the device (10) out of the inserter (20) passing through a distal opening (21B) of the bore.

13. Kit according to claim 12, wherein the distal opening (21 B) of the bore (21) is provided with flexible petals (22) which:

on their distal face, each have a convex profile,

at least partially occlude the distal opening (21 B) when the petals are at rest, and

- are deformable so as to deviate from each other and thus let the device through the distal opening (21 B) when the device (10) is applied against the proximal face of the petals under the effect of the thrust pusher (30).

14.- Kit (1) for collecting cervico-vaginal cells in women, in particular for screening for cervical cancer and infectious diseases of the vagina,

this kit including:

a device (10) according to any one of claims 1 to 1 1, and - A receiving bottle (40), which is adapted to contain at least the brush (100) of the device (10) after removing the latter from the vagina (V).

15.- Kit according to claim 14, wherein the receiving bottle (40) is adapted to contain, in addition to at least the brush (100) of the device (10), a liquid (41) is conservative or reactive.