Isolated biological sample collection device

Abstract

The present invention relates to a self-collection device for biological samples that contains a collection implement (e.g., a "veil", a cushion, a swab, a brush, etc.) for any biological material, preferably from the vagina. At the same time, the device is designed to mix a reactive liquid with the material in a watertight manner for subsequent analysis. Uses of the device include, among others, the detection of pathogens such as human papillomavirus, and the diagnosis of cervical cancer.

Description

[Technical field]

[0001] Objective of the invention The object of the present invention lies in the technical field corresponding to medicine, in particular the field that concerns devices for obtaining biological samples isolated from human subjects.

[0002] The present invention relates to a device for self-collection of biological samples, preferably from the vagina, capable of accommodating any biological material collection implement (a "veil", a cushion, a swab, a brush, etc.) and simultaneously mixing a reactive liquid with said material in a sealed state for subsequent analysis, and its use for, inter alia, the detection of pathogens such as human papillomavirus and the diagnosis of cervical cancer. [Background technology]

[0003] Devices for obtaining biological samples from the vagina or cervix for the detection of diseases related to the female reproductive system are known in the prior art.

[0004] Obtaining a biological sample, such as blood, saliva, or urine, from a patient is the first step in many diagnostic procedures.

[0005] For collection of biological samples from the female's uterus, a material collection tool (swab, brush, cloth, etc.) is used within a device or container with or without transport as a more rapid method for subsequent analysis of the sample in a laboratory.

[0006] In addition, the prior art includes devices that serve to accommodate a sampling tool that has collected a biological sample, the devices comprising a chamber containing a fluid that reacts with the collected substance, said chamber being capable of being destroyed by pressure or tensile stress to release the reactive liquid.

[0007] However, this problem arises when analyzing the collected sample. The devices existing in the prior art are operated by the user, who extracts one of the components that make up the device, so even if the environment in which it is performed is sterile, it increases the risk of sample contamination, which affects the results and leads to incorrect diagnosis of disease. The risk of exposure to biological samples and the means of transportation by the handler when transported also involve the resulting biological risk.

[0008] On the other hand, it can also lead to errors in collecting the amount of liquid reacted with the sample, depending on the ability of the user responsible for performing the analysis, again potentially detecting conditions that may affect the outcome of the test. Summary of the Invention [Problem to be solved by the invention]

[0009] The present invention seeks to solve the problem posed by incorporating a container designed to hold a biological sample collection tool, preferably from the vagina, in which a cap contains a chamber enclosing a reactive liquid and is sealed at the bottom by a sheet that breaks when the cap is screwed on, so that, by screwing the cap on the container, the liquid released from the chamber is allowed to react inside the container with the biological sample collected by the collection tool.

[0010] The device of the present invention allows for the collection of a biological sample isolated from a human subject, preferably (among others) the vaginal cavity, e.g., cells, tissues, or body fluids and / or vaginal secretions, for the detection of pathogens, particularly human papillomavirus (HPV), and the diagnosis of uterine cancer. Examples of pathogens include, but are not limited to, Chlamydia trachomatis, Haemophilus ducreyi, Herpes simplex virus 1 and 2, Mycoplasma genitalium 30, Mycoplasma hominis, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis, and Ureaplasma (urealyticum / parvum), in addition to human papillomavirus (HPV).

[0011] The device of the present invention allows for self-collection of biological samples without the need for specialized medical intervention.

[0012] More specifically, the object of the device of the present invention is to provide a container, as mentioned above, with an essentially tubular body, open at the top and having inside it a collection tool for containing a biological sample, preferably a previously collected biological sample from the vagina, and in addition, said container has an upper head with a diameter essentially wider than the diameter of the tubular body where the internal thread is located.

[0013] However, the present invention also comprises a cap having an upper section and an external thread that is complementary to the internal thread of the head of the container and allows for upper coupling of the cap onto the head of the container in a threaded manner.

[0014] The cap also comprises a portion, which may be tubular and elongated, extending downward from the upper section of the cap to a region near the bottom of the container, the tubular portion terminating in the filter. Around the tubular portion is an annular reservoir containing the reactive liquid and sealed at the bottom by a breakable sheet.

[0015] The body of the container features a series of opening mechanisms, which may be sharp barbs. When the cap is screwed onto the container, these barbs pierce the bottom sheet that encloses the reactive liquid, allowing said liquid to flow through the body of the container and wet the sample collection device. The volume of liquid contained in the reservoir is sufficient to ensure that the amount of liquid reacted with the collected sample flows up the inside of the tubular section through the filter, preventing larger particles from affecting the sample mixed with the liquid.

[0016] To collect the mixed sample in the tubular section, the cap has another breakable sheet in the upper section, designed to reach the reactive liquid by facilitating the passage of a pipette introduced down said tubular section by breaking the sheet.

[0017] Finally, the device also comprises a fixing means which, once joined, prevents the cap from being unscrewed from the container, remaining completely sealed until the moment of taking up the liquid with the pipette, preventing manipulation and contamination of the sample, said fixing means being a series of grooves, generally parallelepiped shaped, located inside the upper head of the container, and an external protrusion, located in the upper section of the cap, with an inclined surface which favours rotational movement in the grooves and subsequent engagement.

[0018] Once inserted, the shape of the protrusions prevents them from coming out of the grooves and secures the cap to the upper head of the vessel, thus preventing contamination of the sample by particles from the surroundings and / or handling.

[0019] In particular, the device of the present invention allows for the collection of biological samples from human subjects to diagnose and detect the presence of pathogens or disease.

[0020] Therefore, another aspect of the present invention is the in vitro use of the above-described biological sample taking device of the present invention for the detection of at least one pathogen.

[0021] In certain embodiments, the pathogens detected by in vitro use of the biological sample collection device of the present invention are selected from the list consisting of Human Papilloma Virus (HPV), Chlamydia trachomatis, Haemophilus ducreyi, Herpes simplex virus 1 and 2, Mycoplasma genitalium, Mycoplasma hominis, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis, and Ureaplasma (urealyticum / parvum), among others.

[0022] Furthermore, another aspect of the present invention is the in vitro use of the above-mentioned biological sample collection device of the present invention for the diagnosis of uterine cancer. [Brief description of the drawings]

[0023] In order to complete the description and to facilitate a better understanding of the features of the present invention, a set of drawings, according to a preferred and practical embodiment of the present invention, are included as an integral part of this description, showing, in an illustrative and non-limiting manner, the following: [Figure 1] FIG. 2 shows a perspective view of a biological sample collection device. [Diagram 2] 1 shows a cross-sectional view of a biological sample collection device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] An embodiment of a biological material collection device will be described with reference to FIGS.

[0025] 1 shows a perspective view of a biological sample collection device comprising a container (1) with an open lower tubular body (2) intended to accommodate a sample collection sheath (15) and an upper head (3) with an internal thread (4), and a cap (5) having an upper section (6) and incorporating an external thread (7), said cap (5) being designed to screw onto the internal thread (4) of the upper head (3) of the container (1). Furthermore, the cap (5) comprises a tubular part (8) extending downwards from the upper section (6).

[0026] For a better visualization of the invention, FIG. 2 shows a cross-sectional view of the device showing a cap (5) that is screwed onto a container (1), with female threads (4) and male threads (7) that may be complementary to each other.

[0027] The downwardly extending tubular section (8) terminates at its distal end in a filter (9). The cap (5) features an annular reservoir (10) around the tubular section (8) that contains a reactive liquid (11). The annular reservoir (10) is sealed at its lower end by a breakable lower sheet (12). The tubular body (2) has barbs (13) that extend upwardly such that when the cap (5) is attached to the upper head (3) of the container (1), the barbs (13) break the lower sheet (12) and allow the reactive liquid (11) to flow 25 into the tubular body (2) and contact and react with the biological material collected by the collection tool (15).

[0028] The volume of fluid in the annular reservoir (10) and the height of the tubular portion (8) are such that the reactive liquid (11) mixed with the biological material is partially introduced into the tubular portion (8) through the filter (9).

[0029] On the other hand, the cap is also characterized by a breakable upper sheet (14) designed to seal the passage into the tubular part (11) and to facilitate the entry of a pipette (16) which is inserted through the tubular part (8) to reach the previously elevated reactive liquid (11) and in a sealed state is able to extract the biological sample from the biological sample-collecting device (15) reacted and mixed with the reactive liquid (11) while preventing any contamination of the sample.

[0030] Finally, as mentioned above, in order to ensure the tightness of the samples and to prevent contamination of the samples and / or manipulation of the device by the user before the samples have been analysed, the invention incorporates fastening means (17) that fasten the cap (5) once it has been attached to the container (1). These fastening means (17) consist of an essentially prismatic groove (18) located inside the upper head (3) of the container (1) and a protrusion (19) located in the upper section (6) of the cap (5) and that is provided with an inclined surface (20) that facilitates the engagement of said protrusion (19) in the groove (18) when the cap (15) is screwed onto the container (1). When the protrusions (19) are engaged in the groove (18), said inclined surface (20) prevents them from dislodging, thereby preventing the cap (3) from being unscrewed from the container (1).

Claims

1. A device for the collection and / or transport of biological samples isolated from human subjects, designed to accommodate a biological sample collection tool (15), comprising a container (1) with an open lower tubular body (2) intended to accommodate said biological sample collection tool (15), and an upper head (3) with an internal thread (4), and a cap (5) with an upper section (6) incorporating an external thread (7), intended to be screwed onto the internal thread (4) of the upper head (3) of said container (1). The cap (5) further comprises a tubular portion (8) extending downward from the upper section (6) and terminating in a filter (9), and an annular reservoir (10) for containing a reactive liquid (11) arranged in the upper section (6) around the tubular portion (8), the annular reservoir (10) being sealed at the lower part by a breakable lower sheet (12), the lower tubular body (2) being a barb (13) that when the cap (5) is screwed onto the upper head (3) of the container (1), the annular reservoir (10) is provided with an upwardly extending barb (13) so as to break the lower sheet (12) and allow the reactive liquid (11) to flow into the lower tubular body (2) and contact and react with the biological material collected by the biological sample collection device (15); the volume of fluid in the annular reservoir (10) and the height of the tubular portion (8) are such that the reactive liquid (11) mixed with the biological material is partially introduced from the tubular portion (8) through the filter (9); The device is characterized in that the cap also comprises a further breakable upper sheet (14) closing said tubular portion (11) and is designed to facilitate the insertion of a pipette (16) through said tubular portion (8) to reach said previously elevated reactive liquid (11), characterized in that said device further comprises fixing means (17) for fixing said cap (5) when said cap (5) is mounted on said container (1), thereby preventing manipulation and contamination of the sample taken.

2. The fixing means (17) an essentially prismatic groove (18) located inside the upper head (3) of the vessel (1); a protrusion (19) located on the upper section (6) of the cap (5), the protrusion (19) having an inclined surface (20) that facilitates engagement of the protrusion (19) with the groove (18) when the cap (15) is screwed onto the container (1), the inclined surface (20) preventing the protrusion (19) from disengaging when the protrusion (19) is inserted into the groove (18), and thus preventing the cap (3) from being unscrewed from the container (1); The device of claim 1 , comprising:

3. 2. The device according to claim 1, wherein the internal thread (4) of the upper head (3) and the external thread (7) of the cap (5) are complementary.

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