Kit for collecting a menstrual blood sample

Abstract

A kit for collecting a menstrual blood sample comprises a menstrual cup (10). The menstrual cup (10) has an opening. The menstrual cup (10) is suitable for collecting the menstrual blood sample. The kit further comprises a collection container (20). The collection container (20) has an opening delimited by a rim (28). The kit further comprises an accessory (30). The accessory (30) has a receiving area for the menstrual cup (10) and a coupling area in shape correspondence with the rim (28) of the collection container (20). The kit has a mounting configuration in which the accessory (30) holds the menstrual cup (10) in its receiving area and receives on its coupling area the rim (28) of the collection container (20), such that the opening of the menstrual cup (10) is oriented towards the interior of the collection container (20). Abstract figure: [Fig.4]

Description

Title of the invention: Kit for collecting a menstrual blood sample

[0001] The invention relates to the technical field of kits for collecting menstrual blood samples, in particular for analyzing these samples in the laboratory. The invention further relates to the technical field of devices for assisting in the collection of such samples.

[0002] The design and implementation of menstrual blood sample collection kits, as well as devices to assist in the collection of such samples, can play a crucial role in the management and early diagnosis of diseases such as endometriosis.

[0003] Endometriosis is a chronic disease affecting nearly one in ten menstruating women. This disease is characterized by the presence of tissue similar to the uterine lining outside the uterine cavity. This tissue is influenced by hormonal changes during each menstrual cycle, which can lead to debilitating pelvic pain. In some cases, endometriosis is a cause of infertility.

[0004] Endometriosis is a disease that is still poorly understood. Its diagnosis generally involves, as a first step, a pelvic ultrasound, then, as a second step, an MRI. These examinations can be supplemented by other radiological or ultrasound examinations, as well as by computer-assisted tomography examinations. However, the diagnosis of endometriosis remains complex since this disease takes various forms. Many avenues aimed at improving its detection and management are currently being explored.

[0005] One of these promising avenues involves analyzing a sample of the patient's menstrual blood. Studies have in fact identified differences in composition between the menstrual blood of a patient with endometriosis and that of a woman without the condition. Such a diagnostic method has the advantage of being non-invasive.

[0006] Currently, there are few solutions to help a patient collect a menstrual blood sample at home, with a view to analyzing this sample in a laboratory.

[0007] Some solutions exist in the form of collection kits. These kits include, for example, a collection bottle intended to receive a used menstrual protection collecting the sample. The menstrual protection can be of the tampon type or of the sanitary napkin type. The collection bottle is then sent for analysis in the laboratory. This analysis usually requires extracting menstrual blood from used menstrual protection, which can be tedious.

[0008] A patient can also collect a sample in a fluid state by using a menstrual cup-type protection and then transferring the contents of this cup into a collection bottle. This method avoids the aforementioned drawback, but also has several disadvantages. First, the patient must handle the dirty cup during the transfer step. Second, in order to minimize the risk of spilling the contents of the cup, the patient is required to carry out the transfer step immediately after removing the cup, which is rather uncomfortable. Finally, since menstrual blood has a viscous consistency, it tends to adhere to the walls of the menstrual cup. This method therefore does not guarantee that the sample contained in the cup is completely poured into the container.

[0009] The invention improves the situation. To this end, a kit for collecting a menstrual blood sample is provided. The kit comprises a menstrual cup. The menstrual cup has an opening. The menstrual cup is suitable for collecting the menstrual blood sample. The kit further comprises a collection container. The collection container has an opening delimited by an edge. The kit further comprises an accessory. The accessory has a receiving area for the menstrual cup and a coupling area in shape correspondence with the edge of the collection container. The kit has a mounting configuration in which the accessory holds the menstrual cup in its receiving area and receives the edge of the collection container on its coupling area, such that the opening of the menstrual cup is oriented towards the inside of the collection container.

[0010] A user of the kit according to the invention can easily collect a sample of menstrual blood in a fluid state herself at home, in particular with a view to sending this sample to an analysis laboratory. Thanks to the accessory, the user does not need to directly handle the cup, once it is held in the receiving area. Furthermore, in its assembled configuration, the kit makes it possible to guarantee complete transfer of the menstrual blood sample contained in the menstrual cup into the container. The kit according to the invention therefore has advantages, in particular, in terms of ergonomics and efficiency.

[0011] Optional features of the invention, complementary or substitutable, are set out below: - in the mounting configuration, the coupling area of ​​the accessory and the edge of the collection container are mutually engaged; - the coupling zone has an internal thread, in shape cooperation with an external thread provided on the collection container; - the kit further has another mounting configuration, in which the accessory holds the menstrual cup in its receiving area and in which the accessory and the collection container together form a support for the menstrual cup, the opening of the menstrual cup being oriented towards the outside of the collection container; - the receiving area of ​​the accessory comprises a support plate pierced with a through-hole, the through-hole having a periphery in shape cooperation with an external surface of the menstrual cup; - the accessory also has a gripping area shaped into one or more ears, extending substantially to the height of the receiving area; - the collection container contains a reactive substance to preserve the integrity of biomarkers contained in cells of the menstrual blood sample, these biomarkers being, in particular, proteins, RNA and DNA; - the kit further comprises a container, separate from the collection container, and in which the container contains a reactive substance to preserve the integrity of biomarkers contained in cells of the menstrual blood sample, these biomarkers being, in particular, proteins, RNA and DNA; - the container has an edge in shape cooperation with the coupling zone of the accessory; - the reagent substance comprises a reagent to ensure the viability and integrity of the cells in the menstrual blood sample; - the reagent comprises one or more components selected from DMEM / F12, a penicillin / streptomycin mixture, amphotericin B, L-Glutamine or EDTA; - the reactive substance comprises a preservative; - the preservative comprises an aldehyde or an alcohol; - the reactive substance includes caspase inhibitors or hexamethylenetetramine.

[0012] The invention also relates to an accessory for assisting in the collection of a menstrual blood sample. The accessory comprises a receiving area for a menstrual cup suitable for collecting a menstrual blood sample. The accessory further comprises a coupling area in shape correspondence with an edge delimiting the opening of a collection container. The accessory is further arranged to hold the menstrual cup in its receiving area while receiving on its area coupling the edge of the collection container, so that an opening of the menstrual cup is facing the inside of the collection container.

[0013] Other characteristics and advantages of the invention are set out in detail in the following description, given with reference to the appended drawings, in which: - [Fig.l] represents a kit according to a first embodiment of the invention, in isometric perspective, this kit being in a first assembled configuration; - [Fig.2] is a side representation of the kit of [Fig.l] in the first assembled configuration; - [Fig.3] represents a section along line AA of [Fig.2]; - [Fig.4] represents the kit of [Fig.l] during the passage of the first mounted configuration to a second mounted configuration, in isometric perspective; - [Fig.5] represents the kit of [Fig.l] in the second assembled configuration, in isometric perspective; - [Fig.6] is a side representation of the kit of [Fig.l] in the second assembled configuration; - [Fig.7] represents a section along line LL of [Fig.6]; - [Fig.8] is analogous to [Fig.5]; - [Fig.9] represents a part of the kit according to the first embodiment of the invention, in isometric perspective; - [Fig. 10] represents a part of the kit according to the first embodiment of the invention, in side view; - [Fig. 11] represents a section along line CC of [Fig. 10]; - [Fig. 12] represents packaging of the kit according to the first method embodiment of the invention in a packaging box, in isometric perspective; - [Fig. 13] represents a part of a kit according to a second embodiment of the invention; - [Fig. 14] represents the kit according to the second embodiment of the invention in a first assembled configuration; - [Fig. 15] represents the kit according to the second embodiment of the invention in a second mounted configuration; - [Fig. 16] represents the kit according to the second embodiment of the invention in a third assembled configuration; - [Fig. 17] is analogous to [Fig. 16]; - [Fig. 18] represents a part of the kit according to the second method of realization of the invention; - [Fig. 19] represents a part of the kit according to the second mode of realization of the invention.

[0014] The drawings and the description below contain, for the most part, elements of a certain character. They may therefore not only serve to better understand the present invention, but also contribute to its definition, if necessary.

[0015] Reference is made to Figures 1 to 12.

[0016] These figures represent a kit for collecting a menstrual blood sample according to a first embodiment of the invention.

[0017] The kit comprises a menstrual cup 10, suitable for collecting a menstrual blood sample. In known manner, the menstrual cup 10 comprises an opening. The menstrual cup 10 further comprises a container portion 12, which has a base, opposite the opening. Here, the container portion 12 further has a wall, which rises from the base towards the opening and flares out. This wall delimits a volume of capacity for the menstrual blood sample. The menstrual cup 10 further comprises a stem portion 14, which extends from the base of the container portion 12, opposite the opening. Here, the menstrual cup 10 also has a rim 16, which surrounds the opening and forms the end of the wall of the container part 12. In known manner, the menstrual cup 10 can be made of a flexible polymer, such as a flexible silicone or a thermoplastic elastomer.

[0018] In known manner, the menstrual cup 10 is put into place by folding the container portion 12 and inserting it into the vagina of a user. The stem portion 14 is left accessible. Thus positioned, the menstrual cup 10 collects the menstrual blood sample and retains it in its container portion 12. Subsequently, the user removes the menstrual cup 10 from her vagina by pulling on the stem portion 14.

[0019] The kit further comprises a collection container, or container 20, as well as a lid 22 for this container 20. The container 20 is suitable for containing a reactive substance. The container 20 is arranged so as to close hermetically with the lid 22, here by screwing. The container 20 has a bottom 24 and an opening, mutually opposite. This opening is wider than the opening of the menstrual cup 10. The container 20 is capable of being placed on a surface by means of its bottom 24. Here, this bottom 24 and this opening each have a generally circular shape. The container 20 further has a wall 26, which rises from its bottom 24 towards its opening. The wall 26 delimits a capacity volume, in particular for the reactive substance. The container 20 also has an edge 28, which delimits its opening and forms the end of the wall 26.Here, the edge 28 is provided with an external thread, while the cover 22 is provided with an internal thread.

[0020] Here, the container 20 contains a reactive substance having the function of preserving the integrity of the biomarkers contained in cells of the menstrual blood sample. These biomarkers are, for example, proteins, RNA and DNA, contained in these cells.

[0021] The reactive substance may comprise a reagent having the function of nourishing and protecting the cells present in the menstrual blood, so as to keep them alive. In particular, this reagent guarantees the viability and integrity of these cells during the transport of the sample between collection and laboratory analysis. The reagent may comprise one or more of the following main components: - DMEM / F12: This component is a mixture of DMEM (from the English equivalent “Dulbecco's Modified Eagle Medium”), which mimics the essential nutrients and physiological environment of mammalian cells, and Ham's F12, which meets the needs of suspension cultures; - Penicillin / Streptomycin: this mixture provides protection against bacterial contamination; - Amphotericin B: this component has antifungal properties which help maintain sterility in an environment; - L-Glutamine: this component stimulates cellular metabolism and protein synthesis; - EDTA: this component facilitates cell detachment and contributes to the stability of enzymatic processes, particularly during transport.

[0022] In addition, the reactive substance may comprise preservatives. These preservatives kill the cells in the sample and preserve them in a state similar to that which they have when they are alive.

[0023] The preservatives may comprise one or more aldehydes. Aldehyde fixation facilitates the preservation of cellular structures and molecular components for analysis. In particular, one or more of the following aldehydes may be used: - Formaldehyde / Paraformaldehyde: these aldehydes have good stability and good fixation properties. They participate in the crosslinking of proteins and preserve cellular morphology; - Glutaraldehyde: this aldehyde is capable of preserving fine cellular structures thanks to its rapid penetration and crosslinking properties; - Glyoxal: This aldehyde has a more selective mode of action than formaldehyde, resulting in better accessibility to the antigen, reduced autofluorescence, and better preservation of protein structure and function.

[0024] The preservatives may further comprise one or more alcohols. Alcohol fixation provides rapid preservation of cellular structures and nucleic acids. In particular, one or both of the following alcohols may be used: - Ethanol: thanks to its rapid penetration and dehydration properties, this alcohol facilitates effective fixation of nucleic acids while preserving their structure; - Methanol: this alcohol has rapid fixing properties and preserves nucleic acids, making them suitable for cytological studies in particular.

[0025] These aldehydes and alcohols may be used in combination with one or more of the main components of the aforementioned reagent. In particular, these aldehydes and alcohols may be used only in combination with DMEM / F12. Alternatively, these aldehydes and alcohols may be used only in combination with PBS (phosphate buffered saline).

[0026] As a replacement for aldehydes and alcohols, the reactive substance may further comprise the following components: - Caspase inhibitors: these inhibitors block the activity of caspases, enzymes crucial in programmed cell death (apoptosis), and thus help prolong the life of these cells; - Hexamethylenetetramine (HMT): this component is a rapid fixing agent, particularly suitable for the preservation of nucleic acid.

[0027] These components may be used in combination with one or more of the main components of the aforementioned reagent. In particular, these components may be used only in combination with DMEM / F12. Alternatively, these components may be used only in combination with PBS (phosphate buffered saline).

[0028] The kit further comprises an accessory 30, arranged so as to form an interface between the menstrual cup 10 and the container 20. The accessory 30 comprises a receiving area for the menstrual cup 10. The receiving area is arranged to hold the menstrual cup 10 on the accessory 30.

[0029] Here, the receiving area is arranged to hold the menstrual cup 10 by friction. Here, the receiving area is shaped as a support plate 32 pierced with a through-orifice 38. The through-orifice 38 has a periphery in shape cooperation with an external surface of the container part 12. The menstrual cup 10 is able to be inserted through the through-orifice 38, until this external surface is engaged with the periphery of the through-orifice 38. Here, this periphery has a generally circular shape. When the menstrual cup 10 is held in the through-hole 38, a portion of its container part 12 as well as its rim 16 are positioned on one side of the support plate 32, while the remainder of its container part 12 as well as its stem part 14 are positioned on another side of the support plate 32. In addition, the receiving area may be provided with a guide surface, extending from the periphery of the through-hole so as to guide the insertion of the menstrual cup through the through-hole.

[0030] Here, the container part 12 is provided with an external rib (not shown), forming a reference for the engagement of the menstrual cup 10 in the receiving zone of the accessory 30.

[0031] In addition or as a replacement, the receiving area may be arranged to engage the menstrual cup other than as described above. For example, the receiving area may be arranged to engage the menstrual cup by clipping between a rib, provided on one of the container portion and the receiving area, and a groove, provided on the other of the container portion and the receiving area.

[0032] The accessory 30 further comprises a coupling zone, in shape correspondence with the edge 28 of the container 20. The coupling zone may comprise, as here, a periphery of the support plate 32 as well as an edge 34 extending from this periphery. Here, the edge 34 extends both from a first side 40 of the support plate 32 and from a second side 42 thereof.

[0033] Here, the accessory 30 is arranged so that the menstrual cup 10 is inserted into the through-orifice 38 of the receiving zone by the first side 40 of the support plate 32. The accessory 30 is further provided so that, when the menstrual cup 10 is held in the through-orifice 38, a portion of its container part 12 as well as its rim 16 are positioned on the first side 40 of the support plate 32, while the remainder of its container part 12 as well as its stem part 14 are positioned on the second side 42 of the support plate 32.

[0034] Here, the accessory 30 is able to be fixed on the container 20 by means of a part of its edge 34 which extends from the first side 40 of the support plate 32. This part is subsequently called the first part of the edge 34. The first part of the edge 34 has an internal surface in shape cooperation with an external surface of the edge 28 of the container 20. Here, this internal surface has a thread, in shape cooperation with the external thread of the edge 28. For example, this thread is similar to the internal thread of the cover 22.

[0035] The edge 34 further has a second portion, which extends from the second side 42 of the support plate 32. Here, the second portion of the edge 34 is devoid of thread. This second portion is arranged to ensure centering of the accessory 30 relative to the container 20, when the accessory 30 is placed in position on the edge 28 of the container 20 with the second side 42 of the support plate 32 oriented towards the bottom 24 of the container 20. Here, the second part of the edge 34 is less high than the first part of this edge 34.

[0036] The accessory may further comprise, as here, a gripping area. The gripping area makes it easier for the user to grasp and manipulate the accessory 30. In particular, the gripping area allows the user not to directly manipulate the menstrual cup 10, once the latter is held in the receiving area.

[0037] The gripping area may be shaped into one or more lugs. Here, the gripping area is shaped into a pair of lugs 36, projecting from the edge 34. Here, each lug 36 has a generally circular shape, slightly curved towards the second side 42 of the support plate 32. Here, the lugs 36 are arranged at the height of the support plate 32. The lugs 36 form a mark to distinguish the first side 40 and the second side 42 of the receiving area from each other.

[0038] In the disassembled state, the kit according to the invention comprises, separately, the menstrual cup 10, the accessory 30 and the container 20, this container 20 containing the reactive substance and being closed by the cover 22. The kit in the disassembled state can be packaged in a packaging box 50, as shown in [Fig. 12]. The packaging box 50 can comprise, as here, a corrugated cardboard plate 52 having three locations, each intended for one of the elements of the kit.

[0039] The kit according to the invention is arranged to be mounted in a first configuration (shown in Figures 1 to 3), in which the menstrual cup 10 is held in the receiving area and the accessory 30 is positioned on the container 20 so that the opening of the menstrual cup 10 is oriented towards the outside of the container 20. This first configuration prevents a transfer of contents between the menstrual cup 10 and the container 20. The container 20 and the accessory 30 together form a support for the menstrual cup 10. The menstrual cup 10 retains its contents, typically the menstrual blood sample, in its container part 12. The container 20 retains its contents, typically the reactive substance, in the volume delimited by its wall 26.

[0040] Here, in this first configuration, the menstrual cup 10 is positioned in the receiving zone so that a portion of its container part 12 as well as its rim 16 are positioned on the first side 40 of the support plate 32, while the remainder of its container part 12 as well as its stem part 14 are positioned on the second side 42 of the support plate 32. The external surface of the container part 12 is engaged with the periphery of the through-orifice 38. The second side 42 of the support plate 32 is oriented towards the bottom 24 of the container 20. The second part of the border 34 surrounds the edge 28 of the container 20, so as to ensure centering of the accessory 30 relative to the container 20.

[0041] To move from the disassembled state of the kit to this first configuration, the container 20 is first placed on a support surface and then the accessory 30 is positioned on the container 20 in the manner indicated above. Then, the menstrual cup 10 is inserted into the receiving area of ​​the accessory 30, until the external surface of its container part 12 is engaged with this receiving area.

[0042] The kit according to the invention is further arranged to be mounted in a second configuration (shown in Figures 5 to 8), in which the accessory 30 holds the menstrual cup 10 in its receiving zone and receives on its coupling zone the edge 28 of the container 20, so that the opening of the menstrual cup 10 is oriented towards the inside of the container 20. This second configuration allows the transfer of contents between the menstrual cup 10 and the container 20. The container part 12 of the menstrual cup 10, the container 20 and the accessory 30 jointly delimit a closed volume, in which the initial contents of the menstrual cup 10, typically the menstrual blood sample, and the initial contents of the container 20, typically the reactive substance, are mixed. The hermeticity of this closed volume is ensured by the correspondence of shape between the coupling zone of the accessory 30 and the edge 28 of the container 20.This hermeticity can be further improved by providing a seal, for example on the container 20.

[0043] In this second configuration, the assembly formed by the accessory 30, the menstrual cup 10 and the container 20 can be shaken and turned over, so as to ensure that the mixture of this sample and the reactive substance is homogeneous and that the entire sample of menstrual blood is transferred into the container 20, despite the viscous consistency of the menstrual blood.

[0044] Here, the transition from the first configuration to the second configuration comprises turning over the assembly formed by the menstrual cup 10 and the accessory 30 relative to the container 20. The relative position of the menstrual cup 10 and the accessory 30 remains the same as in the first configuration. The first side 40 of the support plate 32 is oriented towards the bottom 24 of the container 20. Here, the first part of the edge 34 is engaged with the edge 28 of the container 20, so as to ensure fixing of the accessory 30 on the container 20.

[0045] The following describes a use of the kit according to the first embodiment of the invention: - receive the kit in disassembled condition, in the packaging box 50; - remove the container 20, containing the reactive substance and closed by the cover 22, and place it in the cold, typically at 4°C, for example in a refrigerator; - use the menstrual cup 10 during menstruation; - when the menstrual cup 10 contains a sample of menstrual blood of approximately 5 ml, use container 20 and accessory 30; - place the container 20 on a support surface; - remove the cover 22 from the container 20; - position the accessory 30 on the container 20, orienting the second side 42 from the support plate 32 to the bottom 24 of the container 20 (here, for example, the presence of the thread on the first part of the edge 34 and its absence on the second part of the edge 34 form a reference for the distinction between the first side 40 and the second side 42 of the support plate 32; the user can also use the reference formed by the ears 36); - remove the menstrual cup 10; - position the menstrual cup 10 in the receiving area of ​​the accessory 30, its opening being oriented upwards so as to keep the menstrual blood sample inside the container part 12; - insert the menstrual cup 10 into the receiving area of ​​the accessory 30, until the external surface of its container part 12 is engaged with this receiving area: the kit is then in its first configuration (shown in figures 1 to 3).

[0046] Since the accessory 30 and the container 20 form a support for the menstrual cup 10, the user is free to move. In particular, the user has the possibility of putting herself in good conditions, for example by getting up and washing her hands, before proceeding with the following steps. These steps are as follows: - grasp the ears 36 and turn the assembly formed by the accessory 30 and the menstrual cup 10 over relative to the container 20, so as to pour the sample of menstrual blood contained in the menstrual cup 10 onto the reactive substance contained in the container 20 (step shown in [Fig. 4]); - position the assembly formed by the accessory 30 and the menstrual cup 10 on the container 20, the opening of the menstrual cup 10 being oriented towards the bottom 24 of the container 20: the kit is then in its second configuration (shown in figures 5 to 8); - fixing the assembly formed by the accessory 30 and the menstrual cup 10 to the container 20, here by screwing the first part of the edge 34 of the accessory 30 onto the edge 28 of the container 20; - shake and turn over several times the assembly formed by the container 20, the menstrual cup 10 and the accessory 30, so as to guarantee that the entirety the menstrual blood sample is transferred into the container 20 and in such a way as to homogenize the mixture of menstrual blood and reactive substance (step shown in particular in [Fig.8]); - remove the accessory 30 and the menstrual cup 10 from the container 20; - close the container 20 with the cover 22 (step shown in figures 9 to 11); - replace the container 20 in the packaging box 50.

[0047] The menstrual blood sample thus collected in the container 20 is ready to be sent to an analysis laboratory. If the shipment is not immediate, the packaging box 50 containing the container 20 is placed in the cold, typically at 4°C, for example in a refrigerator.

[0048] Reference is made to Figures 13 to 19.

[0049] These figures represent a kit for collecting a menstrual blood sample according to a second embodiment of the invention. Elements similar to those described in relation to the first embodiment are designated by the same reference signs, increased by one hundred.

[0050] The menstrual cup 110 has a function and structure similar to those of the menstrual cup described in connection with the first embodiment. The container 120 has a structure similar to that of the container described in connection with the first embodiment.

[0051] This second embodiment is distinguished firstly from the first embodiment in that the container 120 does not contain a reactive substance. The reactive substance is contained in an additional part of the kit, shaped as a container 160. The container 160 is arranged so as to form a cover for the accessory 130. Here, when the container 160 is arranged on the accessory 130, the assembly has a generally ovoid shape. The container 160 has an edge delimiting an opening. Here, this edge is analogous to the edge 128 of the container 120. Here, in particular, the edge of the container 160 is in shape cooperation with the coupling zone of the accessory 130, so as to guarantee the airtightness of the volume delimited between this container 160 and the accessory 130. Here, the edge of the container 160 has an external thread, in shape cooperation with an internal thread provided on the coupling zone of the accessory 130.The container 160 further has a wall 166, which delimits a volume of content for the reactive substance. The container 160 also has a seal, which covers its opening when the kit is in the disassembled state, so as to keep the reactive substance inside the container 160. Here, the kit is arranged so that the seal opens when the edge of the container 160 is screwed onto the coupling zone of the accessory 130.

[0052] The second embodiment is then distinguished from the first embodiment by the shape of the accessory 130. The accessory 130 has a base 134 and an opening, mutually opposite. The accessory 130 is capable of being placed on a surface by means of its base 134. The accessory 130 further has a wall 136, which rises from its base 134 towards its opening. The wall 136 surrounds the receiving area for the menstrual cup 110. The accessory 130 also has a coupling area, in shape correspondence with the edge 128 of the container 120 and in shape correspondence with the edge of the container 160. Here, this coupling area is shaped into an edge 138, which delimits the opening of the accessory 130 and forms the end of the wall 136. Here, this edge 138 is provided with an internal thread, in shape cooperation with the external thread of the edge 128 of the container 120 and, here, with the external thread of the edge of the container 160.

[0053] The receiving area of ​​the accessory 130 is shaped as a cavity 132, opening onto the opening of the accessory 130. The cavity 132 has an entrance whose periphery cooperates in shape with an external surface of the container part 112 of the menstrual cup 110. The menstrual cup 110 is able to be inserted into the cavity 132, until this external surface is engaged with the periphery of the entrance of the cavity 132. Here, this periphery has a generally circular shape. When the menstrual cup 110 is held in the cavity 132, a portion of its container part 112 as well as its rim 116 are positioned outside the cavity 132, while the remainder of its container part 112 as well as its stem part are positioned inside the cavity 132. The periphery of the entrance to the cavity 132 may be provided, as in [Fig. 14], with a seal 133.

[0054] The accessory 130 further has a receiving zone 135, which extends between its edge 138 and the periphery of the entrance to the cavity 132. The receiving zone 135 has a generally frustoconical shape, which widens from the periphery of the entrance to the cavity 132 towards the edge 138. The receiving zone 135 helps guide the insertion of the menstrual cup 110 into the cavity 132. The receiving zone 135 also helps guide a fluid flow from the opening of the accessory 130 towards the menstrual cup 110, when the latter is held in the cavity 132.

[0055] In this second embodiment, the kit has at least three mounting configurations.

[0056] In a first configuration (shown in [Fig. 14]), the menstrual cup 110 is held in the receiving area of ​​the accessory 130, such that the opening of the menstrual cup 110 is oriented towards the outside of the cavity 132. The accessory 130 forms a support for the menstrual cup 110. The menstrual cup 110 retains its contents, typically the menstrual blood sample, in its container portion 112.

[0057] To move from the disassembled state of the kit to this first configuration, the menstrual cup 110 is inserted into the receiving area of ​​the accessory 130, until the external surface of its container part 112 is engaged with this receiving area.

[0058] In a second configuration (shown in [Fig. 15]), the accessory 130 holds the menstrual cup 110 in its receiving zone and receives on its coupling zone the edge of the container 160, so that the opening of the menstrual cup 110 is oriented towards the inside of the container 160. The lid of the container 160 is open. This second configuration allows the transfer of contents between the menstrual cup 110 and the container 160. More particularly, when the accessory 130 is placed on a support surface, this second configuration allows the transfer of the contents of the container 160 into the menstrual cup 110 and the receiving zone 135 of the accessory 130. The conformation of the receiving zone 135 helps to guide the flow of the contents of the container 160 towards the menstrual cup 110.

[0059] Here, the transition from the first configuration to the second configuration comprises screwing the edge of the container 160 onto the edge 138 of the accessory 130, which results in an opening of the seal covering the container 160 and a release of the reactive substance contained therein inside the accessory 130. The relative position of the menstrual cup 110 and the accessory 130 remains the same as in the first configuration.

[0060] In a third configuration (shown in Figures 16 and 17), the accessory 130 holds the menstrual cup 110 in its receiving area and receives on its coupling area the edge 128 of the container 120, so that the opening of the menstrual cup 110 is oriented towards the inside of the container 120. This third configuration allows the transfer of contents between the container 120 and the inside of the accessory 130, and more particularly between the container 120 and the menstrual cup 110. The container part 112 of the menstrual cup 110, the container 120 and the receiving area 135 of the accessory 130 jointly delimit a closed volume, in which the menstrual blood sample and the reactive substance are mixed. The hermeticity of this closed volume is ensured by the correspondence of shape between the coupling zone of the accessory 130 and the edge 128 of the container 120.

[0061] In this third configuration, the assembly formed by the accessory 130, the menstrual cup 110 and the container 120 can be shaken and turned over, so as to ensure that the menstrual blood sample and the reactive substance are mixed homogeneously and fully transferred into the container 120.

[0062] Here, the transition from the second configuration to the third configuration comprises removing the container 160 from the accessory 130, and placing the container 120 in its place. The relative position of the menstrual cup 110 and the accessory 130 remains the same.

[0063] The following describes a use of the kit according to the second embodiment of the invention: - receive the kit in its disassembled state, in the packaging box; - take out the container 160, containing the reactive substance and closed by the lid, and place this container 160 in the cold, typically at 4°C, for example in a refrigerator; - use the 110 menstrual cup during menstruation; - when the menstrual cup 110 contains a sample of menstrual blood of approximately 5 ml, take container 160, container 120 and accessory 130; - place the accessory 130 on a support surface; - remove the menstrual cup 110; - position the menstrual cup 110 in the receiving area of ​​the accessory 130, its opening being oriented upwards so as to keep the menstrual blood sample inside the container part 112; - insert the menstrual cup 110 into the receiving area of ​​the accessory 130, until the external surface of its container part 112 is engaged with this receiving area: the kit is then in its first configuration (shown in [Fig. 14]); - fix the edge of the container 160 on the edge 138 of the accessory 130, so as to open the seal and pour the reactive substance contained in the container 160 into the menstrual cup 110 and the reception area 135 (step shown in [Fig. 15]): the kit is then in its second configuration; - remove the container 160 from the accessory 130; - fix the container 120 on the assembly formed by the accessory 130 and the menstrual cup 110, here by screwing the edge 128 of the container 120 onto the edge 138 of the accessory 130: the kit is then in its third configuration (step shown in [Fig. 16]); - shake and turn over several times the assembly formed by the container 120, the menstrual cup 110 and the accessory 130, so as to homogenize the mixture of menstrual blood and reactive substance and to transfer all of this mixture into the container 120 (step shown in figures 16 and 17); - remove the container 120 from the assembly formed by the accessory 130 and the menstrual cup 110; - close the container 120 with the cover 122 (step shown in [Fig.19]); - place the container 120 in the packaging box.

[0064] The menstrual blood sample thus collected in the container 120 is ready to be sent to an analysis laboratory.

[0065] The invention is not limited to the embodiments described above, but encompasses all variants conceivable by those skilled in the art. In particular:

[0066] An accessory has been described whose coupling zone is arranged to engage by screwing with the edge of the container. As an alternative, the accessory and the container may have other means of mutual attachment. As an alternative again, the accessory and the container may be devoid of mutual attachment means, manual pressure distributed over the accessory and the container being sufficient to guarantee the airtightness of the volume delimited by the container part of the menstrual cup, the container and the accessory.

[0067] A receiving area is described that is arranged such that when the menstrual cup is held therein, a portion of its container portion and its rim are positioned on one side of the receiving area, while the remainder of its container portion and its stem portion are positioned on the other side of the receiving area. Alternatively, the receiving area may be arranged such that when the menstrual cup is held therein, its rim is positioned on one side of the receiving area, while its container portion and its stem portion are positioned on the other side of the receiving area. In this embodiment, the rim of the menstrual cup may abut against the receiving area.

Claims

Claims

1. A kit for collecting a menstrual blood sample, the kit comprising: a menstrual cup (10,110), having an opening, the menstrual cup (10,110) being suitable for collecting the menstrual blood sample, a collection container (20,120), having an opening delimited by an edge (28,128), an accessory (30,130), having a receiving area for the menstrual cup (10,110) and a coupling area in shape correspondence with the edge (28,128) of the collection container (20,120), the kit having a mounting configuration in which the accessory (30,130) holds the menstrual cup (10,110) in its receiving area and receives on its coupling area the edge (28,128) of the collection container (20,120), such that the opening of the menstrual cup (10,110) is oriented towards the inside of the collection container (20,120).

2. The kit of claim 1, wherein, in the mounting configuration, the coupling area of ​​the accessory (30,130) and the edge (28,128) of the collection container (20,120) are mutually engaged.

3. Kit according to one of claims 1 and 2, in which the coupling zone has an internal thread, in shape cooperation with an external thread provided on the collection container (20,120).

4. A kit according to any preceding claim, further comprising a further mounting configuration, wherein the accessory (30) holds the menstrual cup (10) in its receiving area and wherein the accessory (30) and the collection container (20) together form a holder for the menstrual cup (10), the opening of the menstrual cup (10) being oriented towards the outside of the collection container (20).

5. Kit according to one of the preceding claims, in which the receiving area of ​​the accessory (30) comprises a support plate (32) pierced with a through-orifice (38), the through-orifice (38) having a periphery in shape cooperation with an external surface of the menstrual cup (10).

6. Kit according to one of the preceding claims, in which the accessory (30) further has a gripping zone shaped as one or more ears (36), extending substantially at the height of the receiving zone.

7. Kit according to one of the preceding claims, wherein the collection container (20) contains a reactive substance for preserving the integrity of biomarkers contained in cells of the menstrual blood sample, these biomarkers being, in particular, proteins, RNA and DNA.

8. Kit according to one of claims 1 to 3, further comprising a container (160), separate from the collection container (120), and in which the container (160) contains a reactive substance to preserve the integrity of biomarkers contained in cells of the menstrual blood sample, these biomarkers being, in particular, proteins, RNA and DNA.

9. Kit according to claim 8, in which the container (160) has an edge in shape cooperation with the coupling zone of the accessory (130).

10. A kit according to any one of claims 7 to 9, wherein the reactive substance comprises a reagent for ensuring the viability and integrity of the cells in the menstrual blood sample.

11. A kit according to claim 10, wherein the reagent comprises one or more components selected from DMEM / F12, a penicillin / streptomycin mixture, amphotericin B, L-Glutamine or EDTA.

12. A kit according to any one of claims 7 to 11, wherein the reactive substance comprises a preservative.

13. A kit according to claim 12, wherein the preservative comprises an aldehyde or an alcohol.

14. A kit according to any one of claims 7 to 11, wherein the reactive substance comprises caspase inhibitors or hexamethylenetetramine.

15. Accessory for assisting in the collection of a menstrual blood sample, comprising on the one hand a receiving area for a menstrual cup (10,110) suitable for collecting a menstrual blood sample, and on the other hand a coupling area in shape correspondence with an edge (28,128) delimiting the opening of a collection container (20,120), said accessory being further arranged to hold the menstrual cup (10,110) in its receiving area while receiving on its coupling area the edge (28,128) of the collection container (20,120), so that an opening of the menstrual cup (10,110) is oriented towards the inside of the collection container (20,120).

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