Device for the intracorporeal collection of menstrual blood

Abstract

A device (100) for the intracorporeal collection of menstrual blood is proposed. The device (100) is cup-shaped and is formed from a flexible material. It is characterized by a stem-shaped outlet (20) with a predetermined opening point (30). Furthermore, the device comprises at least one filter (40, 50, 51). The device is particularly suitable for the collection of a sample for carrying out a fertility examination.

Description

[0001] R. 416153

[0002] Description

[0003]

[0004] The present invention relates to a device for the intracorporeal collection of menstrual blood, an adapter for the device, a kit for the intracorporeal collection of menstrual blood, and a use of the device.

[0005] State of the art

[0006] Blood is an important sample material for diagnostic analysis. Blood is usually drawn by medical personnel in a minimally invasive manner, either by syringe from a vein or by pricking / pricking a fingertip.

[0007] One analysis that can be performed using a blood sample is the fertility test (fertility check).

[0008] It is well known that natural fertility declines in women with age. It is known that by quantifying certain hormones relevant to fertility, information about a woman's actual fertility can be obtained. This fertility test, compared to reference values ​​for these hormones, provides a snapshot of the woman's fertility status at a given moment.

[0009] In recent years, there has been a growing demand among the population for self-administered diagnostic tests. Various diagnostic tests are already available, either for home use or for sending samples collected at home to a laboratory for analysis.

[0010] Unlike, for example, saliva as a sample material, obtaining blood as a sample material is not easy for private individuals. Therefore, R. 416153 prohibits this.

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[0012] Self-collection of blood using a syringe for medical reasons. A blood sample for home use is therefore usually taken from the fingertip. Small lancets are used for this purpose, with which a fingertip is pricked so that the emerging blood can be collected. However, pricking the fingertip oneself is usually painful or at least unpleasant. Furthermore, it can sometimes be difficult to obtain a sufficient amount of blood for the respective test.

[0013] Another option for obtaining blood for analysis in women of reproductive age is menstrual blood. So-called dry blood cards are used to collect menstrual blood; these collect the blood in dried form for analysis.

[0014] It is already known that a menstrual cup can be used to collect and dispose of menstrual blood. Menstrual cups are reusable cup- or chalice-shaped containers made of materials such as silicone or soft rubber, which are inserted into the vagina to create a vacuum and collect the menstrual blood. The small container can be emptied and rinsed as needed before being reused.

[0015] EP 4042988 A1 describes a menstrual cup which has an outlet at its base for disposing of menstrual blood. This outlet can be closed by a stopper.

[0016] Patent DE 202017106300 U1 also relates to a menstrual cup that has an outlet at its base which can be closed by a stopper. The stopper additionally has a cleaning element that serves to remove any blood clots that may be present when cleaning the menstrual cup.

[0017] EP 4406488 A1 discloses an adapter for transferring a blood-containing sample into a sealable sample container so that the blood can be sent to an analytical laboratory. This adapter is specifically designed for transferring menstrual blood from a menstrual cup into a sealable sample tube. The adapter is equipped with a filter. R. 416153

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[0019] equipped with which cells, tissue, secretions or other solid components of the sample can be separated from the blood to be examined.

[0020] Disclosure of the invention

[0021] The invention proposes a device for the intracorporeal collection of menstrual blood, wherein the device is particularly cup-shaped and made of a flexible material, for example, silicone or soft rubber. The proposed device is characterized in that it has a stem-shaped outlet with a predetermined opening. The device, which is particularly cup- or funnel-shaped, preferably tapers towards the stem-shaped outlet. Furthermore, the device comprises at least one filter.

[0022] Similar to a conventional menstrual cup, the device can be inserted into the vagina, creating a vacuum so that menstrual blood can be collected intracorporeally. This blood is collected intracorporeally and non-invasively, making it available in liquid form for analysis. After removing the device from the body, the blood can be transferred to an analysis system via the stem-shaped outlet. Specifically, the stem-shaped outlet can be connected to an analysis system, allowing for direct and automated blood transfer from the device to the system. The stem-shaped outlet thus serves as an interface to the analysis system. Furthermore, the stem-shaped outlet also facilitates removal of the device, as it is easy for the user to grasp.

[0023] The at least one filter in the device allows for the removal of potential contaminants that could interfere with the analysis, such as mucosal components or tissue clumps. Furthermore, the at least one filter allows for the targeted removal of various interfering factors and / or the concentration of specific analytes. Additionally, the filter can be used, for example, to homogenize the blood. In this context, a filter can also be understood as a sieve. R. 416153

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[0025] Overall, the proposed device can be used to obtain menstrual blood of analytical grade, particularly in liquid form.

[0026] The blood sample can be transferred directly from the device to the analysis system after collection. This eliminates additional steps associated with sample transfer and simplifies the overall analysis process. Furthermore, the need for additional sample transfer equipment is eliminated; for example, pipettes or similar tools are not required. Additionally, the potential loss of sample material, which can occur with conventional methods due to the extra handling of the sample during transfer, is avoided. Finally, the problem of potential sample degradation during transport and storage is eliminated, as the blood can be used for analysis immediately after collection.

[0027] The device is very comfortable for the user and, compared to conventional methods of blood collection, is painless, less prone to error, and less time-consuming. The proposed menstrual blood collection device is therefore particularly suitable for home use, for example, for checking hormone levels or for testing for possible bacterial, viral, or fungal infections. In particular, the proposed device allows for independent, rapid blood tests at home, without the need for medical personnel. Lab-on-a-chip systems, which are generally easy to operate, can be used as analytical instruments, especially for home applications.

[0028] In a particularly preferred embodiment, the device comprises at least one coarse filter and at least one fine filter. The coarse filter serves in particular to separate larger contaminants, such as clumped material and tissue or mucous membrane remnants. The coarse filter is preferably located in a region of the device with a large cross-section, i.e., in particular outside the outlet of the device.

[0029] In particular, the coarse filter is located in a central collection area of ​​the device. This positioning has the advantage that it allows for a large surface area of ​​the coarse filter, which is essential for retaining coarse particles. 416153

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[0031] It is helpful in removing impurities while simultaneously preventing the coarse filter from becoming clogged and blocked.

[0032] The fine filter allows for the targeted removal of specific interfering factors or the enrichment of specific target molecules (analytes). In particularly preferred embodiments, the at least one fine filter is located in the outlet of the device. Preferably, the device comprises at least two fine filters, both of which are preferably located in the outlet of the device.

[0033] Positioning the fine filter(s) in the outlet has the advantage that the sample material is inevitably passed through the filter. Furthermore, this arrangement results in a relatively small filter area, as the cross-section of the device is narrowed at this position. Therefore, only a small amount of material is required for the fine filter(s).

[0034] By using two or, if necessary, more fine filters in the apparatus, it is possible to prepare the sample material very selectively through the respective filtration. In particular, various interfering factors or impurities can be selectively removed by the two or more fine filters. Furthermore, it is possible to selectively concentrate different analytes in the sample.

[0035] In particularly preferred embodiments, the at least one filter is therefore configured for the selective (active) binding of components in the menstrual blood. In these embodiments, the at least one filter can, for example, be equipped with immobilized antibodies against the respective components. In this way, certain interfering factors can be removed. Furthermore, it is possible for the antibodies to selectively enrich certain analytes, for example, certain hormones such as estrogen and / or follicle-stimulating hormone (FSH) and / or anti-Müllerian hormone (AMH) or inhibin A and / or inhibin B, or other analytes. For this purpose, the immobilized antibodies bind specifically to these hormones.

[0036] For subsequent analysis, the enriched analytes can be eluted from the filters using, for example, suitable elution buffers and selectively eluted so that they can be transferred to the analytical instrument. R. 416153

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[0038] Instead of antibodies, other affinity materials can also be used for the respective purposes in the filter or filters of the device.

[0039] Furthermore, it is possible to prepare the blood sample by using suitable filters with a view to obtaining serum or plasma, which may be used for analysis.

[0040] Suitable filter materials for the coarse filter are those with an exclusion limit in the range of approximately 200 pm to 5 mm, and especially between 500 pm and 2 mm. If necessary, several coarse filters with progressively smaller pore sizes can be connected in series to prevent clogging.

[0041] Filter materials with an exclusion limit in a range between 2 and 800 pm are particularly suitable for the fine filter.

[0042] Filter materials with an exclusion limit in a range between 5 and 500 pm are particularly preferred, preferably in a range between 5 and 200 pm.

[0043] Depending on the specific application of the device, finer filter materials can also be used, which, for example, have an exclusion limit of 0.65 pm or 0.45 pm or 0.2 pm, in order to filter out bacteria and / or fungi if this is useful for the respective application.

[0044] For example, a fine filter with a pore size of 5 pm and a coarse filter with a pore size of 500 pm can be combined.

[0045] The actual material of the respective filter can be, in particular, a flexible mesh or a membrane made of plastic, for example PET (polyethylene terephthalate), PP (polypropylene), nylon, PC (polycarbonate), PVDF (polyvinylidene fluoride), cellulose acetate, PES (polyethersulfone) or others.

[0046] In particularly preferred embodiments, the intended opening point is located in the outlet of the device for mechanical opening and / or thermal opening and / or opening by suction (fluidic) and / or opening by pressure (compression of the device) and / or opening by gravity. R. 416153

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[0048] and / or an opening mechanism using ultrasound. Such mechanisms for opening the outlet allow for a particularly simple transfer of the sample from the device to an analysis apparatus. For example, the desired opening point can be opened mechanically in a particularly simple manner by pressure or by means of a needle, a mandrel, or a plunger. Other preferred options include, for example, wax valves that melt and open at an elevated temperature.

[0049] The transport of the sample from the device into the analysis unit can be actively driven. For example, a plunger can be used to mechanically push the sample out of the device. Alternatively, sample transport can be fluidic, achieved through suction, compression of the device, or simply by gravity.

[0050] In advantageous embodiments of the device, the device can be provided with calibration marks. In this embodiment, the user can at least roughly estimate the collected volume of the sample and, in particular, read whether the desired or required sample volume has been achieved during collection.

[0051] In further preferred embodiments, the device can be sealed with a lid, preferably irreversibly, after the menstrual blood has been collected. The lid preferably forms a tight seal. Such a seal is particularly advantageous in cases where a certain amount of time elapses between sample collection and further processing or analysis of the sample. Furthermore, such a seal after sample collection also allows the sample to be transported if the actual analysis is to be carried out at another location, for example, in a laboratory.

[0052] In preferred embodiments, the lid can be equipped with at least one pressure equalization device, for example a pressure equalization valve or an opening. Such a pressure equalization device facilitates sample removal or transfer of the sample through the outlet into the analysis device. R. 416153

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[0054] In particularly preferred embodiments, the device is characterized by the fact that its interior is at least partially coated. A coating can be provided, in particular, on the inner wall of the device in the area where the sample is collected and / or on the inner wall of the outlet area. The coating can, for example, be an anti-protein-binding coating. This prevents proteins, which may be the target analytes of the sample, from adhering to the inner wall. Another possibility is a coating of the inner wall with proteins, which blocks the inner wall, so that in this case, too, no adhesion of potential target analytes occurs to the inner wall.

[0055] In particularly preferred embodiments, the device can be inserted into an adapter, the adapter being designed for transferring the collected menstrual blood to an analysis device. For this purpose, the device containing the collected blood is inserted into the adapter after it has been drawn from the body. The adapter is preferably dimensionally stable. The cup-shaped device itself is made of a flexible material to allow for comfortable insertion into the body. Therefore, the device itself is generally not dimensionally stable. The adapter provided in these preferred embodiments can thus significantly simplify the further handling of the non-dimensionally stable device after sample collection. For example, the adapter can be made of a rigid material, such as plastic, and be funnel-shaped.

[0056] The adapter preferably includes a tube-like extension for the sample outlet. When the device is inserted into the adapter, the stem-shaped outlet of the device is positioned within this tube-like extension. The tube-like extension can be connected to an analysis device, allowing for easy transfer of the sample from the device to the analysis device, such as a sample input chamber.

[0057] In addition to or as an alternative to a possible lid for the device itself, the adapter can also be closed with a lid in preferred embodiments. Handling of the device is therefore particularly easy and hygienic using such an adapter. R. 416153

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[0059] The invention further comprises such an adapter, which is configured to receive the device and to transfer the menstrual blood collected in the device to an analysis unit. For further features of this adapter, reference is made to the description above.

[0060] The invention further comprises a kit for the intracorporeal collection of menstrual blood. This kit includes the described device for the intracorporeal collection of menstrual blood, as well as an adapter for receiving the device and for transferring the menstrual blood collected in the device to an analysis unit. For further features of these components of the kit, reference is made to the description above.

[0061] Finally, the invention includes a use of the described device or kit for the intracorporeal collection of menstrual blood.

[0062] In particularly preferred embodiments of this application, fractions of the collected menstrual blood are selectively and / or sequentially extracted for analysis. For this purpose, the device incorporates one or more fine filters that allow for the selective enrichment of predefined analytes in the sample. These filters contain, for example, appropriate antibodies or other affinity materials to which the respective analytes bind. By introducing suitable elution buffers or similar substances into the device, the analytes retained on the fine filters can be selectively eluted as individual fractions, thus releasing and extracting these analytes for analysis. If two or more fine filters with immobilized affinity materials are provided, the different analytes can be eluted sequentially.

[0063] In this way, a sequential analysis of different fractions is possible. Furthermore, the specific binding to the filters leads to an enrichment of the analytes, which can significantly increase the sensitivity of the analysis. The invention therefore also relates to the collection and fractional analysis of menstrual blood. R. 416153

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[0065] In a particularly preferred embodiment of the application, menstrual blood is used for hormone analysis. Hormone analysis can be used particularly advantageously for fertility testing.

[0066] Traditionally, such a fertility check is performed in a doctor's office, as this requires a blood sample to be drawn and analyzed in a laboratory. The device according to the invention, however, and its use allow the woman to collect a liquid blood sample herself at home, thus significantly reducing the effort required for the analysis. Particularly in combination with the use of a self-administered rapid test for the analysis of the aforementioned hormones, for example, using a lab-on-a-chip cartridge, considerable advantages arise, for instance, when performing a fertility check.

[0067] Obtaining a patient sample in the form of liquid menstrual blood has the advantage over, for example, a saliva sample, that a liquid blood sample allows for the analysis of more hormones, such as all the relevant hormones for a fertility check. Other sample types (such as saliva or urine) often do not contain all the hormones relevant for testing.

[0068] Furthermore, the time window of menstrual bleeding optimally covers the recommended sampling time for the relevant time-critical hormones (days 2-5 of the cycle), making the proposed device particularly suitable for sampling to perform a fertility check.

[0069] In particularly preferred embodiments of this aspect of the invention, a telemedicine interface may be provided so that the measurement data can be integrated, for example, into the treatment of a desire to have children in a particularly simple way.

[0070] The invention therefore relates, with particular advantage, to the non-invasive obtaining of a blood sample for hormone analysis with regard to fertility analysis. R. 416153

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[0072] For this purpose, liquid menstrual blood, i.e., not dried menstrual blood, can be obtained as sample material in a home application, possibly processed and used for analysis.

[0073] For this purpose, it can be particularly advantageous if, during sample collection, the menstrual blood is processed in such a way as to obtain serum or plasma. The menstrual blood collection device described above, which is equipped with one or more filters, is particularly suitable for this purpose.

[0074] Preferably, an evaluation algorithm can be integrated into the entire system of sampling and the actual analysis. This algorithm calculates, in particular, the hormone concentrations and their absolute values, and assesses the relevant factors regarding fertility status, so that a corresponding result, possibly including a recommendation for action, can be generated.

[0075] When collecting samples for hormone analysis, and in particular for fertility checks, the collected blood is preferably coarsely filtered to remove any agglomerates and / or other coarse impurities. This coarse filtration is advantageously performed directly in the menstrual blood collection device by means of a coarse filter integrated into the device.

[0076] Furthermore, sample preparation advantageously includes the generation of blood serum or blood plasma, as these fractions are particularly suitable for hormone analysis. This step can also be advantageously integrated directly into the menstrual blood collection device using appropriately suited filters.

[0077] For the detection and, if necessary, quantification of hormones in the sample, an ELISA test can be used, for example, in a suitable home analysis system. In particular, sequential tests for one hormone at a time in singleplex format or multiplex tests, in which all relevant analytes are analyzed in one sample with a single measurement, are possible. R. 416153

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[0079] In a further preferred embodiment of the described device, the collected menstrual blood can be used to analyze infection status. In particular, it can be used to investigate the status of a possible bacterial, viral, or fungal infection. The sample can be particularly advantageously analyzed, for example, for HPV (human papillomavirus) infection, which is of particular interest with regard to the risk of cervical cancer.

[0080] Another aspect of the invention relates to a method for analyzing components, in particular hormones, in menstrual blood, especially with regard to a fertility examination and / or for analyzing an infection status, comprising the following steps:

[0081] a) intracorporeal collection of menstrual blood using the device according to the invention

[0082] b) optional inclusion of the device in the adapter according to the invention c) inclusion of the device or the adapter by an analysis device, in particular a lab-on-a-chip analysis device

[0083] d) Opening the intended opening point of the stem-shaped outlet of the device. The intended opening point can be achieved, for example, mechanically and / or thermally and / or by suction and / or by pressure and / or by gravity and / or by ultrasound.

[0084] e) Selective and / or sequential extraction of fractions of the collected menstrual blood. Analytes bound to at least one filter can also be eluted as described above.

[0085] g) Analysis of the components to be analyzed contained in the collected menstrual blood, in particular the analytes such as hormones.

[0086] Further features and advantages of the invention will become apparent from the following description of exemplary embodiments in conjunction with the drawings. The individual features can be implemented individually or in combination with one another.

[0087] Brief description of the drawings

[0088] The drawings show: R. 416153

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[0090] Figure 1 schematic representation of a first embodiment of a device according to the invention for the intracorporeal collection of menstrual blood;

[0091] Figure 2 schematic representation of a further embodiment of a device according to the invention with illustration of opening possibilities of the intended opening point of the device;

[0092] Figure 3 schematic representation of a device according to the invention in combination with an adapter; and

[0093] Figure 4 schematic representation of a further embodiment of a device according to the invention with two fine filters.

[0094] Description of exemplary implementations

[0095] Fig. 1 shows a device 100 for the intracorporeal collection of menstrual blood. The device 100 is cup-shaped and has a central collection chamber 10 and a stem-shaped outlet 20. A predetermined opening 30 is provided at the end of the stem-shaped outlet 20. The stem-shaped outlet 20 is hollow, resembling a hose or tube. In this embodiment of the device 100, a coarse filter 40 is located in the central collection chamber 10 for removing coarse impurities from the collected blood. A fine filter 50 is located in the area of ​​the outlet 20 and can be configured to remove specific interfering factors or to concentrate specific analytes.

[0096] Furthermore, a lid 60 is provided. The lid 60 allows the device 100 to be sealed leak-proof after sample collection.

[0097] If necessary, the cover 60 can be applied irreversibly. Furthermore, it is advantageous if the cover 60 is provided with a pressure equalization device 61, for example a valve or an opening.

[0098] Device 100 is made of a soft, flexible material, such as silicone or soft rubber. Similar to a conventional menstrual cup, the device can be folded and stored in the R. 416153

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[0100] The device is inserted into the vagina towards the uterus. A vacuum is created, and the device remains there temporarily to collect menstrual blood.

[0101] The stem-shaped outlet 20 serves as a removal aid when removing the device 100 from the body, as it is easy to grip. Furthermore, the stem-shaped outlet 20, and in particular the designated opening 30, forms an interface to an analysis device 300, for example, a lab-on-a-chip cartridge. During the collection of menstrual blood, the designated opening 30 is closed and sealed. The designated opening 30 is only opened outside the body. For example, automatic opening can be provided as soon as contact with the analysis device 300 is established.

[0102] For example, the analyzer 300 can be equipped with an inlet 310 into which the stem-shaped outlet 20 is inserted. The opening 30 can then be opened, allowing the collected sample to flow into the analyzer 300. This can be actively driven by the analyzer 300, for example, by suction (negative pressure). Sample transport can also be driven, for example, by compression of the device 100 or solely by gravity. The particular advantage is that no manual transfer or handling of the sample is required. Instead, the blood sample flows directly from the device 100 into the analyzer 300.

[0103] Fig. 2 illustrates various possibilities for opening the intended opening point 30 of the device 100. In the embodiment of the device 100 shown here, no coarse filter is provided. Otherwise, the device 100 shown here corresponds to the embodiment from Fig. 1. The corresponding elements are therefore provided with the same reference numerals.

[0104] To open the intended opening point 30, the lower part of the illustration indicates possible mechanisms for opening: treatment with ultrasound, opening with a needle or awl, or opening by increased temperature. Opening by increased temperature is particularly suitable if the intended opening point 30 is sealed with wax. R. 416153

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[0106] the wax seal melts at a certain temperature, releasing the opening.

[0107] Fig. 3 illustrates the use of an adapter 200 in handling the device 100. The device 100 itself corresponds to the embodiment shown in Fig. 1 and is provided with the same reference numerals.

[0108] The adapter 200 is funnel-shaped and designed so that, after sample collection and removal of the device 100 from the body, the device 100 can be inserted into the adapter 200. Corresponding to the stem-shaped outlet 20 of the device 100, the adapter 200 has a tube-like extension 220. In a first state (shown on the left side of the figure), the tube-like extension 220 is closed at the bottom. In this state, the tube-like extension 220 of the adapter 200, together with the inserted device 100 containing the collected blood, is inserted into an inlet 310 of a corresponding analysis device 300, for example, a lab-on-a-chip cartridge.After connecting the device 100 to the analysis unit 300, in a second state (shown with the adapter 200 on the right side of the figure) the designated opening 30 is opened, for example by cutting off the end of the tube-like extension 220 of the adapter 200, so that the sample liquid can flow into the analysis unit 300. The adapter 200 thus facilitates the transfer of the sample into the analysis unit.

[0109] Alternatively, the lower part of the tube-like extension 220 of the adapter 200 can generally be open downwards, so that after inserting the device 100 into the adapter 200, the stem-shaped outlet 20 of the device 100 protrudes and the adapter 200 does not need to be cut off or otherwise processed before or after insertion into the inlet 310 of a corresponding analysis device 300 (also shown on the right side of the figure) and the intended opening point 30 of the device 100 can be opened as described in Figure 2.

[0110] In this embodiment, the cover 60 can serve either to close the device 100 itself or to close the adapter. R. 416153

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[0112] Fig. 4 illustrates the possibilities through the use of several fine filters 50, 51 in the device 100. Otherwise, the embodiment of the device 100 shown in this figure corresponds to that of Fig. 1. The various elements are therefore provided with the same reference numerals.

[0113] On the right side of the figure, the two fine filters 50, 51 are shown in isolated form.

[0114] The coarse filter 40 (coarse sieve) in the area of ​​the central collection area 10 is intended for general sample preparation or for pre-cleaning the menstrual blood in the form of removing / retaining coarse impurities, such as blood or mucosal agglomerates.

[0115] The downstream fine filters 50, 51, located in the outlet 20 of the device 100, have a smaller pore size or mesh size than the coarse filter 40. These fine filters 50, 51 are intended for further, in particular more intensive and, if necessary, more specific sample preparation.

[0116] In a particularly preferred configuration, the fine filters 50 and 51 are equipped with specific affinity materials, especially antibodies. The corresponding components of the collected blood bind to these affinity materials. This allows, on the one hand, the specific removal of certain interfering factors and / or the enrichment of specific analytes. Furthermore, sample fractionation is possible in this way, whereby the fractions bound to the respective fine filters can be selectively eluted from the sample using appropriate elution buffers and, if necessary, analyzed sequentially.

[0117] For example, after inserting the device 100 into an analysis unit, the liquid sample or fraction that has passed through all the filters can first be drawn / into the analysis unit.

[0118] Subsequently, in the case of a sequential analysis, the further analytes bound on filters 50 and 51 can be sequentially eluted from the filters using suitable buffer systems and then entered into the analysis.

[0119] By actively binding one or more target analytes on the fine filter(s), it is possible to selectively prepare the sample for the planned analyses. R. 416153

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[0121] To prepare the blood sample, in particular, it can be fractionated and split into three fractions for the analysis of Analyte 1, Analyte 2, and Analyte 3. The first fraction, 70, is the filtered blood that has passed through all filters, 40, 50, and 51. This fraction can be analyzed for Analyte 1, for example. The second fraction is obtained by selectively eluting the components (Analyte 2) bound to the first fine filter, 50 (containing immobilized antibody: anti-Analyte 2). This fraction can be analyzed for Analyte 2. The third fraction is obtained by selectively eluting the components (Analyte 3) bound to the second fine filter, 51 (containing immobilized antibody: anti-Analyte 3). This fraction can be analyzed for Analyte 3.

[0122] Alternatively, filters 50 and 51 can be used to remove interfering factors. These filters selectively retain these interfering factors, preventing them from affecting the analysis of the through-flow fraction. These interfering factors could include, for example, highly concentrated blood components that could interfere with the analysis.

Claims

R. 416153 - 18 - Claims 1. Device (100) for the intracorporeal collection of menstrual blood, wherein the device (100) is in particular cup-shaped and is made of a flexible material, characterized in that the device (100) has a stem-shaped outlet (20) with a predetermined opening point (30) and comprises at least one filter (40, 50, 51).

2. Device (100) according to claim 1, characterized in that the device (100) comprises at least one coarse filter (40) and at least one fine filter (50, 51).

3. Device (100) according to claim 2, characterized in that the at least one fine filter (50, 51) is located in the outlet (20).

4. Device (100) according to claim 3, characterized in that the device comprises at least two fine filters (50, 51).

5. Device (100) according to one of the preceding claims, characterized in that the at least one filter (50, 51) is configured for the selective binding of components, in particular of at least one interfering factor and / or of at least one analyte, in particular of at least one hormone in the menstrual blood.

6. Device (100) according to claim 5, characterized in that the at least one filter (50, 51) comprises immobilized antibodies for binding the at least one interfering factor and / or for binding the at least one analyte, in particular the at least one hormone.

7. Device (100) according to claim 6, wherein the immobilized antibodies are configured to specifically bind estrogen and / or follicle-stimulating hormone (FSH) and / or anti-Müllerian hormone (AMH) or inhibin A and / or inhibin B. R. 416153 - 19 - 8. Device (100) according to one of the preceding claims, characterized in that the intended opening point (30) is configured for mechanical opening and / or thermal opening and / or opening by suction and / or opening by pressure and / or opening by gravity and / or opening by ultrasound.

9. Device (100) according to one of the preceding claims, characterized in that the device (100) can be closed with a lid (60), in particular irreversibly, after the collection of the menstrual blood.

10. Device (100) according to claim 9, characterized in that the lid (60) has at least one pressure equalization device (61).

11. Adapter (200) for a device (100) according to one of claims 1 to 10, characterized in that the adapter (200) is designed to receive the device (100) and to transfer the menstrual blood collected in the device to an analysis device (300).

12. Kit for intracorporeal collection of menstrual blood comprising a device (100) according to any one of claims 1 to 10 and an adapter (200) according to claim 11.

13. Use of a device (100) according to any one of claims 1 to 10 or of a kit according to claim 12 for intracorporeal collection of menstrual blood for fertility testing and / or for analysis of infection status.

14. Method for analyzing components, in particular hormones, in menstrual blood, especially with regard to fertility testing and / or for analyzing infection status, comprising the following steps: a) intracorporeal collection of menstrual blood by means of a device (100) according to any one of claims 1-10 or by means of a kit according to claim 12 b) optionally receiving the device (100) in an adapter (200) according to claim 11 or 12R. 416153 - 20 - c) Picking up the device (100) or the adapter (200) by an analysis device (300), in particular a lab-on-a-chip analysis device; c) Opening the intended opening point (30) of the stem-shaped outlet (20) of the device (100) e) selective and / or sequential removal of fractions of the collected menstrual blood f) Analysis of the components to be analyzed contained in the collected menstrual blood

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