Collection devices, kits, manufacturing processes, sampling methods and use

Abstract

The present invention relates to a collection device (1) for collecting at least one specimen from a body cavity of a human or an animal, comprising: an elongated flat pouch (20) having: an open end (200); a top side edge (201) opposite to the open end (200), the top side edge being located at a proximal end (101) of the collection device (1); and two transverse side edges (202, 204); and two folding devices (32, 34), each of which has a There is a fixed end (301) and a free end (303), wherein the fixed end is fixed at or near the top side edge (201) in the pouch (20), and the free end freely extends from the open end (200), and the collecting device is configured so that when the free ends (303) of the two wrinkling devices (32, 34) are pulled in opposite directions, the short side (201) of the pouch (20) is brought closer to the open end (200), and the pouch (20) presents a wrinkled shape (22). Preferably, the collection device further comprises two fabric sheets (40, 41) fixed to each other by a fastening element (25), such as a welding line located about 1 mm to 10 mm from the proximal edge (401) of the sheets (40, 41), to form two proximal flaps (44, 46), which are fixed to each other by the fastening element (25) so that the two flaps (44, 46) can be transformed from a closed state (47) to an open state (49). The present invention also relates to the use of the collection device (1) for sampling at least one specimen from a body cavity of humans and animals, a kit and method for sampling, and a process for producing the collection device (1).

Description

Technical Field

[0001] The present invention relates to the field of sampling of specimens, such as cells, cell residues, proteins, deoxyribonucleic acid (DNA), ribonucleic acid (RNA) and / or other substances taken from a body cavity (e.g., vaginal cavity, rectal cavity, oral cavity or nasal cavity). Background Art

[0002] The collection of specimens such as cytology samples, DNA samples, RNA samples, viral samples (such as coronavirus or HPV) and / or biological samples for testing, research and diagnosis (especially for cervical cancer or sexually transmitted diseases (STIs)) usually requires complex examinations and often painful sampling by trained professionals (doctors or nurses). Traditionally, gynecologists perform such sampling for the detection of cervical cancer or sexually transmitted diseases on women by inserting a speculum into the patient's vagina to expose the cervix of the uterus, and then inserting a cervical scraper (with a swab or brush) for sampling tissue from the endocervical canal and cervical os. The cervical scraper is designed to scrape tissue in order to collect tissue samples. During the entire process, the woman must maintain a reclining (gynecological) position. Finally, the obtained specimen is directly smeared on a slide or placed in a receiver containing a liquid preservative for the analysis and evaluation steps. However, in approximately 30% of cases, a satisfactory specimen cannot be collected by this technique, resulting in the need to repeat the procedure or obtaining erroneous or incomplete results. Recently, self-sampling devices, methods and kits have been developed that allow the user to collect specimens privately and / or following less invasive procedures.

[0003] WO2019 / 106408 discloses a self-sampling kit, which includes a sampling cloth designed to be inserted into a body cavity, a sealable receiver for storing the sampling cloth and transporting it to a laboratory, and an applicator for inserting the sampling cloth into the body cavity. The disclosed sampling cloth is suitable for collecting specimens, is flexible, prevents damage, has an absorbency of less than 3.5 g / g measured using the Syngina protocol for measuring the absorbency of tampons, and has a small thickness and is heat-fusible. The sampling cloth in the document is made of a piece of fabric sheet that can be folded to form a small bag for inserting the applicator. After removal, the sampling cloth is inserted into a sealed receiver and sent to a diagnostic institution. The document requires that "at least one of the openings of the receiver is of a size sufficient to allow a user of the kit to easily insert a sampling cloth into the receiver, preferably without squeezing the sampling cloth, which might otherwise cause part of the collected specimen to be removed. The size of the opening will therefore depend on the width of the sampling cloth." In fact, trying to insert a soft, flexible cloth into the receiver without losing part of the collected specimen may be difficult and the sealable receiver must be quite large, which also means that a correspondingly large amount of preservation fluid must be provided therein, so the entire kit becomes large, heavy and expensive. This is a serious disadvantage, especially for developing countries. Summary of the invention

[0004] The object of the present invention is to provide an inexpensive sampling cloth, sampling kit and method, which have improved accuracy and efficiency in sampling, self-sampling and preservation of specimens such as cells, cell residues, DNA, RNA, proteins, viruses, bacteria, parasites or fungi and / or other substances of interest from body cavities of humans and animals.

[0005] This object is achieved by a collection device according to the invention. In another aspect, the invention relates to a kit comprising a collection device according to the invention and a suitable receiver and applicator. In another aspect, the invention relates to the use of the collection device for sampling at least one specimen from a body cavity of humans and animals, a process for manufacturing the collection device and a method for self-sampling and diagnosis.

[0006] definition

[0007] Sampling refers to the process of obtaining a specimen, where the sampling procedure can be performed by a professional (e.g., a physician or nurse), by an individual on himself or herself, or by an individual on another person or animal without the assistance of a trained professional.

[0008] Specimen refers to any cells, cell residues, DNA, RNA, proteins, viruses, bacteria, parasites, fungi and / or other substances of interest.

[0009] The collection device according to the present invention is designed to be inserted into a body cavity of a human or an animal by an applicator. Therefore, an insertion direction is defined, which is the direction of an axis intersecting the collection device and oriented from the end of the collection device that remains outside the body cavity (called the distal end of the collection device) to the end of the collection device that first contacts the body cavity (called the proximal end of the collection device). When viewed along the insertion direction, the top or upper part of the collection device is represented by the end of the collection device including its proximal point; the proximal point is the point that first contacts the body cavity. At the same time, the bottom or lower part of the collection device is represented by the end of the collection device including its distal end; the distal end is the point in the collection device opposite to the proximal point, that is, located at the position farthest from the proximal point in the insertion direction. In some embodiments, a part of the collection device protrudes from the vaginal or rectal cavity to the outside. In this case, the bottom of the collection device will also include this part of the collection device. Taking into account the above definitions, the lateral sides of the collection device will be the left end and the right end in view of the top and bottom as defined above.

[0010] According to the present invention, "on", "above" or "above it" will refer to a first point or a first part that is located closer to the top of the acquisition device relative to a second point of reference, and the second point will be located "below", "below" or "below it" of the first point or first part, respectively.

[0011] According to the invention, "upward orientation" means orientation towards the top of the collecting device, while "downward orientation" means orientation towards the bottom of the collecting device. "Forward movement" is understood according to the invention as movement in the direction of insertion of the collecting device into the cavity.

[0012] The Disclosure

[0013] Collection device

[0014] One aspect of the present invention relates to a collection device for collecting at least one specimen from a body cavity of a human or an animal, the collection device having: a proximal end, which is the end of the device that first contacts the body cavity during use; and a distal end, which is opposite to the proximal end, the collection device comprising:

[0015] - an elongated flat pouch having: an open end; a short side, also called top side and opposite the open end and towards or at the proximal end of the collecting device; and two long sides, also called lateral sides and preferably having a length greater than the length of the short sides; and

[0016] - two corrugating means, each of which has a fixed end fixed inside the pouch at or near the short edge and a free end extending freely from the open end,

[0017] The collecting device is configured so that when the free ends of the two corrugating devices are pulled in opposite directions, the short side of the pouch is brought closer to the open end and the pouch presents a corrugated shape, and each of the opposite directions is substantially perpendicular to one of the two long sides.

[0018] In a preferred embodiment of the present invention, the collection device includes at least one additional segment formed integrally with the fabric of the pouch, the additional segment extending from the open end of the pouch toward the distal end of the collection device, and its size is designed so that after the collection device is inserted into the body cavity, the at least one additional segment protrudes out of the body cavity and can be used to remove the collection device from the body cavity.

[0019] Another aspect of the invention relates to the use of a collecting device for collecting at least one specimen from a body cavity of humans or animals.

[0020] Material

[0021] The elongated flat pouch of the present invention is made of a material suitable for introduction into a body cavity such as the vagina or rectum. Therefore, the pouch can be comfortably placed in the body cavity.

[0022] The suitable material will be flexible, which is understood to be a material that will bend and straighten to follow the shape of the body cavity. Moreover, the suitable material is preferably atraumatic, which is understood to be a material that can contact or slide or wipe the body membrane surface such as the vaginal or rectal mucosa without causing any damage or causing discomfort such as irritation, pain, etc., preferably a fabric with a soft, coarsely combed, smooth surface. The use of a pouch made of such a flexible atraumatic material has the advantage of avoiding irritation, pain and discomfort to the body cavity during insertion. Therefore, when the pouch is introduced into the body cavity by means of an applicator, the fabric of the pouch located above and around the applicator will protect the vaginal mucosa from direct contact with the hard material of the applicator.

[0023] Advantageously, as mentioned in document WO2019 / 106408, a suitable material for the pouch is a material that is capable of capturing a specimen from a body cavity and preferably retaining the specimen on its surface, while being able to subsequently easily release the specimen so that the specimen can be analyzed. Therefore, the pouch advantageously has a surface that will be in contact with the body cavity but has a small or no absorbency, so that only a small amount of the specimen is absorbed into the fabric of the pouch, while most of the specimen remains attached to the surface of the pouch. For this purpose, the absorbency should preferably be less than 3.5 g / g measured using the Syngina protocol for measuring the absorbency of tampons, more preferably less than 3 g / g, and most preferably less than 2 g / g. For example, an absorbency of 3.5 g / g means that 3.5 grams of liquid are absorbed per 1 gram of material. Preferably, the pouch is made of a fabric with a thinner thickness. A pouch with a thinner thickness is capable of capturing a specimen on its surface, but the pouch will not or only rarely transfer, collect and retain the specimen in the depth of the pouch. The advantage of such a pouch is that, unlike a sponge or tampon, the pouch will not retain the collected specimen (cells, proteins, DNA, etc.) inside during the analysis and evaluation steps. Instead, the pouch will easily release the specimen from the pouch, so the final number of specimens to be analyzed is maximized, which improves the precision (accuracy) of the sampling test. The thickness of the pouch should be 3 mm or less, preferably 2 mm or less, more preferably 1 mm or less, even more preferably 0.6 mm or less, which means that the thickness of the pouch is much smaller than that of an ordinary tampon. Advantageously, the material of the pouch has a density of about 60 g / m 2 About 70g / m 2 The basis weight.

[0024] Professionals are known to have the above-mentioned characteristics and are suitable for various materials for sampling in the body cavity. An illustrative list of such materials can be found in WO2019 / 106408, the disclosure of which is incorporated herein by reference as a whole. That is, the material suitable for the pouch inserted into the body cavity comfortably can be selected from the group consisting of woven or non-woven textiles, which are, for example, made of synthetic fibers (e.g., polyester, polypropylene, polyethylene, polyamide, polyacetate, polyvinyl acetate), semi-synthetic fibers (e.g., viscose, modal, lyocell), plant fibers (e.g., cotton), animal fibers (e.g., silk), or combinations thereof. In a preferred embodiment, the material is biodegradable, thereby reducing the impact on the environment. Preferably, the material is a non-woven textile made of synthetic fibers, because this material is damage-resistant and has a desired lower absorbency. Moreover, such products can have a lower production cost. In a preferred embodiment, the material is also heat-fusible so that it can be welded. In a more preferred embodiment, the pouch is made of a nonwoven fabric having a soft, rough, smooth surface, the nonwoven fabric comprising a nonwoven polyethylene / polyester bicomponent. Preferably, such a fabric has the following properties:

[0025] - Average basis weight (mass per unit area), measured using WSP130.1 test method, the average basis weight is about 59.20 g / m 2 ,

[0026] - Average tensile strength MD, which represents the force per unit width required to rupture a sample oriented in the machine direction, measured using a test method following WSP 110.4 using a sample width of 25.4 mm (1 inch), a grip distance of 127 mm (5 inches) and a speed of 500 mm / min (19.7 inches / min), the average tensile strength MD is about 48.86 N / inch,

[0027] - Average elongation at F-max MD, which represents the relative increase in length under the maximum force applied to a sample oriented along the machine direction, the average elongation at F-max MD is measured using a test method following WSP 110.4 using a sample width of 25.4 mm (1 inch), a clamp distance of 127 mm (5 inches) and a speed of 500 mm / min (19.7 inches / min), and the average elongation at F-max MD is about 38.40%.

[0028] size

[0029] The collection device according to the present invention is suitable for insertion into a body cavity, such as the vagina, rectum, oral cavity, or nasal cavity of a human or animal. Therefore, those skilled in the art will understand that the size of the collection device is selected to be suitable for the body cavity into which the collection device is to be inserted.

[0030] For example, the vagina and rectum are open cavities in the form of fibromuscular tubes whose walls are easily dilated. The vagina is in the form of a tube with an external opening (vaginal opening) and an internal opening (communicating with the uterus) at the end. The rectum is in the form of a tube with an external opening (anus) and an internal opening (communicating with the large intestine) at the end; near the external opening, the rectum has an enlarged part, i.e., the ampulla of the rectum, where it is intended to accommodate the pouch according to the invention. The external openings of both the vagina and the rectum are substantially circular. The width (diameter) of the tubes (vagina and rectum) varies over their entire length, with the minimum width being at the external opening of the body cavity. For example, the vagina or rectum of an adult under resting conditions has a width of about 2.5 cm at the external opening.

[0031] Regardless of the shape of the collection device when it is outside the body cavity, due to the fact that the collection device is made of flexible fabric, when inserted into the body cavity by pushing the collection device through the substantially circular external opening, the collection device will collapse, for example, deform, fold, tighten and / or twist to pass through the external opening, and will then unfold to generally follow the shape of the cavity. Therefore, the size of the collection device for insertion into the human vaginal or rectal cavity will be selected so that the maximum width of the collection device in the collapsed position will be less than 2.5 cm, so that the collection device can be inserted into the body cavity comfortably. In a preferred embodiment, the width of the collection device for vaginal sampling can be selected, for example, between 1 cm and 4 cm, preferably between 1 cm and 3 cm, most preferably between 1 cm and 2 cm, for example between 1.2 cm and 1.5 cm. Such a size will be sufficient to collect samples from the entire inner surface of the vagina, while keeping the size of the collection device small enough to be more comfortably inserted and retained in the body cavity and also less expensive to produce and can be loaded into a receptacle that is also cheaper and smaller in size.

[0032] When the collection device is inserted into a body cavity, this means that after the collection device has been pushed into the body cavity it will preferably occupy a position where the proximal end is closest to the internal opening of the body cavity. The distance from the proximal end to the distal end of the collection device defines the length of the collection device. Thus, the technician will be able to shape / select the size of the collection device according to the expected size of the body cavity to be sampled.

[0033] For example, a collection device for vaginal sampling may have a length of about 8 cm to 16 cm, preferably about 10 cm to 14 cm, such as about 12 cm to 13 cm, depending on, for example, the age, ethnic group or medical history of the intended recipient.

[0034] Folding device

[0035] The crumpled condition refers to a condition in which the pouch assumes a collapsed, folded, generally accordion-like shape such that the short sides of the pouch are closer to the open end of the pouch than when the pouch is in an extended, uncrumpled shape.

[0036] Each of the corrugating means is preferably in the form of a wire, cord, strip or ribbon.

[0037] Each of the creasing devices has a fixed end and a free end, the fixed end being fixed at or near the short side of the pouch inside the pouch, and the free end being freely extended from the open end of the pouch. The length of the creasing devices is adjusted so that their distal free ends extend far enough from the open end of the pouch so that each of the distal free ends can be grasped by hand (e.g., between two fingers) and pulled to cause the pouch to crimp. For example, the distal free end extends at least 10 mm from the pouch.

[0038] As described above, each of the corrugating devices has a fixed end that is fixed in the pouch at at least one fixed point located at or near the short side of the pouch. The corrugating device can be attached to the pouch in any suitable manner known in the art, such as by welding, sewing, gluing, stapling, buttoning, knotting or gluing, so that it will allow good fixation without detaching from the pouch during use. In a preferred embodiment, the short side of the pouch is represented by a welding area, which also welds the end of the corrugating device to the pouch. Preferably, the welding area consists of at least two welding rows, each of which consists of welding points and / or welding lines.

[0039] By grasping the free ends of the two crimping devices and pulling the free ends in opposite directions, each substantially perpendicular to one of the two long sides of the pouch, the short sides of the pouch are brought closer to the open end, while the pouch assumes a crimped shape. When pulled, the two crimping devices exert pressure on the two long sides at contact areas (also called hinge points) located at the distal ends of the long sides. These contact areas serve as bending points of the crimping devices. By pulling the crimping devices, the crimping devices exert pressure on the long sides of the pouch at the bending points, while pulling the fixing points of these crimping devices at the short sides of the pouch. This causes the long sides of the pouch to slide along the crimping devices towards the short sides of the pouch at the bending points, and forces the crimping devices to assume a crimped shape. Thus, the entire pouch adopts a crimped shape, the dimensions of which are significantly smaller than the dimensions of the pouch in its stretched shape. For example, in one embodiment, a collection device of a pouch having a stretched shape and having a length of 12 cm reaches a length of about 4.5 cm in the crimped shape.

[0040] Reducing the size of the pouch by giving it a corrugated shape has the advantage that the collection device can be accommodated in a smaller receiver for transportation to a testing facility. In addition, the corrugated shape of the pouch has significantly greater rigidity than the stretched shape of the pouch. This makes the pouch easier to manipulate and introduce into the receiver, further allowing the use of a smaller receiver that uses less raw material and is less expensive to produce. When the collection device is introduced into the receiver, the pouch is introduced first, which means that the pouch in the corrugated state is the first part of the device to enter the receiver, and the fact that the pouch becomes rigid due to the corrugated state makes it easier to introduce the pouch. For example, the user can introduce the pouch first when easily introducing the collection device, holding the collection device by the distal end of the corrugated device, thereby avoiding the risk of contamination by touching the pouch. Moreover, the sealable receiver used to accommodate the collection device and transport it to the laboratory usually contains a medium for preserving or preparing the sampled specimen, such as distilled water, saline or culture medium, or such a medium is added to the receiver at the laboratory. Since the pouch, which represents the main sampling part of the collection device, has a reduced size, the pouch can be completely immersed in the smaller volume of the storage device.

[0041] The crimping device can be made of any material that will not tear when the force required to crimp the bag into a crimped shape is applied to the bag. Preferably, the breaking resistance of such a device is higher than 50N, such as cotton yarn with a metric count Nm of 16 / 4.

[0042] In a preferred embodiment, the crimping means is made of an elastic material, which ensures that the pouch retains its crimped shape for a longer period of time. A crimped pouch tends to slowly return to a less compact shape after the user stops pulling on the crimping means. If the crimping means is made of an elastic material, then when released, the crimping means elastically contracts to return to a shorter size. While contracting, the elastic material of the crimping means captures and fixes the folds of the pouch and thus does not allow the pouch to return to a less compact shape. This allows the user more time to transfer the collection device into the receptacle without causing the pouch to lose its compact small size, and ensures that the pouch remains crimped after insertion into the receptacle, so that the pouch can remain fully immersed in a small amount of preservation liquid.

[0043] In one embodiment, the collection device has dimensions such that during sampling only the corrugated device protrudes from the body cavity. In this embodiment, the corrugated device also serves as a device for removal from the body cavity.

[0044] In other embodiments, the collection device has a size that allows a portion of the pouch to extend out of the body cavity during sampling. This extended distal end of the pouch can be used as a means for removing the pouch from the body cavity by itself or with the folding device extending from the body cavity.

[0045] In yet another preferred embodiment, the collection device has at least one additional segment, for example made of the same fabric as the pouch, extending from the open end of the pouch toward the distal end of the collection device. The additional segment (s) remains outside the body cavity during sampling and can be used as a means for removing the collection device from the body cavity. Preferably, the length of the folding device of this embodiment is such that the free end of the folding device does not exceed the distal end of the additional segment (s). The advantage of this embodiment is that it ensures that the user uses the additional segment as a means for removing the collection device. The folding device does not extend beyond the additional segment (s) and is not used as a removal device, or these folding devices are only grasped together with the additional segment. This avoids the possibility that the pouch is turned inside out during the removal process by pulling the folding device to remove the collection device, and thus the collected specimen enters the pouch and becomes more difficult to release. At the same time, in this embodiment, the additional segment extending from the body cavity is more comfortable for the user than when the pouch extends.

[0046] Additional segments(s)

[0047] In some embodiments, the collection device of the present invention further comprises at least one additional segment, for example made of the same fabric sheet (or fabric sheets) as the pouch, the additional segment extending from the open end of the pouch to the distal end of the collection device. The additional segment (or multiple additional segments) extends out of the body cavity during sampling so that it / they can be used as a device for removing the pouch from the body cavity. Preferably, each of the at least one additional segment is made of a flat fabric sheet, which means a single fabric sheet having a substantially two-dimensional shape, i.e., not folded or fixed to other sheets. More preferably, at least one additional segment (or multiple additional segments) has a V-shape, which means that the segment gradually narrows downward from the open end of the pouch to the distal end of the collection device. The advantage of this V-shape is that it makes it easier to see and grasp the free end of the folded device. In addition, for example for vaginal or rectal collection devices, during sampling, when the pouch is inserted into the cavity, this V-shape is more comfortable for the user to wear for a long time outside the body cavity.

[0048] In a preferred embodiment, the collecting device has two further sections, both of which have the mentioned V-shape.

[0049] Two sheets

[0050] In some embodiments, the collecting device comprises two fabric sheets, each fabric sheet having a proximal edge at the proximal end of the collecting device, a distal edge at the distal end of the collecting device, and two lateral edges. Embodiments in which the collecting device comprises two fabric sheets are preferred because the method of producing the collecting device from two fabric sheets is simple and fast, as will be explained further.

[0051] Fastening elements

[0052] The fabric sheets are secured to each other by fastening elements such as continuous weld lines, rows of spot welds, stitching lines and / or gluing lines, which fastening elements form the short sides and the two long sides of the pouch.

[0053] Welding point angle

[0054] In a preferred embodiment, the fastening elements forming each of the two long sides of the pouch are a single straight row of welds having a substantially elongated shape. Such elongated welds have a long axis, a proximal end, and a distal end. In a preferred embodiment, the elongated welds are placed in corresponding rows so that the long axis of the welds forms a similar angle with the direction of the corresponding row of welds. In a preferred configuration, the similar angle is an acute angle formed by the long axis of the welds and the direction of the proximal end of the corresponding long side toward the collection device. Therefore, the proximal end of each weld is simultaneously closer to the short side of the pouch and the longitudinal center axis of the pouch. The effect of this arrangement is that when the corrugation device is pulled, the angled welds cause the pouch to fold into small, uniform, regular, symmetrical corrugations, thereby presenting a compact corrugated shape that is easier to introduce into the recipient's body.

[0055] Two or more rows on the short side

[0056] In a preferred embodiment, the fastening elements forming the short side of the pouch are made of two or more rows of welding points and / or continuous welding lines. For example, the short side of the pouch can be made of two rows of welding points and a continuous welding line between the two rows of welding points. The fastening elements at the short side made of two or more rows and / or welding lines are more resistant to the urging force of the applicator. In addition, this is also advantageous for embodiments in which two creasing devices are fixed to the inside of the pouch by the fastening elements forming the short side of the pouch. Multiple welding rows and / or welding lines ensure a stronger and more secure fixation of the creasing devices.

[0057] rectangle

[0058] In one embodiment, the two long sides of the pouch are parallel to each other and perpendicular to the short sides. Thus, the fastening element forms a rectangular three-sided shape, wherein the short sides of the rectangle form the short sides of the pouch and the long sides of the rectangle form the long sides of the pouch. In a preferred embodiment, the long sides of the pouch are located at or near the lateral edges of the sheet.

[0059] Additional segments

[0060] In a preferred embodiment, each fabric sheet has a segment fixed to the other sheet to form a pouch, and at least one of the fabric sheets has an additional segment at the distal edge that is not fixed. The additional segment (multiple additional segments) can remain outside the body cavity and serve as a means for removing the collection device from the body cavity. Preferably, at least one additional segment (multiple additional segments) narrows downward from the open end of the pouch toward the distal end of the collection device, which makes it easier for the user to see and grasp the free end of the folding device. Moreover, for example for vaginal or rectal collection devices, this gradually narrowing shape makes the user feel more comfortable to wear for a longer time outside the body cavity during sampling. In a preferred embodiment, both sheets have additional segments with the mentioned gradually narrowing shape (e.g., V-shaped).

[0061] Furthermore, in a preferred embodiment, the free end of each of the crimping means may extend distally of the pouch to a point at least 10 mm beyond the open end of the pouch but not beyond the distal edge of the longer of the further segments. This arrangement will prevent a user from using the crimping means as the sole means of removing the collection device from a body cavity, so that the pouch will not be turned inside out during removal.

[0062] Folding piece

[0063] An alternative collection device may include two fabric sheets, each having a proximal edge positioned toward the proximal end of the collection device and a distal edge positioned toward the distal end of the collection device, wherein the fabric sheets are secured to each other by fastening elements (such as continuous weld lines, spot weld lines, sutures and / or glue lines) located at a distance of about 1 mm to 10 mm, such as 1 mm to 3 mm, 1 mm to 5 mm, 1 mm to 8 mm from the proximal edges of the fabric sheets. Preferably, the collection device includes two fabric sheets, each having a proximal edge located at the proximal end of the collection device and a distal edge located at the distal end of the collection device, wherein the fabric sheets are secured to each other by fastening elements (such as continuous weld lines, spot weld lines, sutures and / or glue lines) to form a pouch having:

[0064] - open end;

[0065] - a short side opposite the open end and towards the proximal end of the collecting device; and

[0066] - two lateral sides,

[0067] Therein, the short side of the pouch is located at a distance of about 1 mm to 10 mm, such as 1 mm to 3 mm, 1 mm to 5 mm, or 1 mm to 8 mm from the proximal edge of the sheet.

[0068] Since the fastening element is located at a distance of, for example, 1 mm to 10 mm from the proximal edges of the two fabric sheets, the two fabric sheets form two proximal flaps towards the proximal end of the collecting device, the proximal flaps representing the sections of the two sheets extending from the fastening element (e.g. the short edge of the pouch) to the proximal edge of each fabric sheet. The two flaps can be symmetrical, meaning that they have similar shapes and sizes, or the two flaps can be asymmetrical, meaning that they can have shapes and sizes that are different from each other. As described above, the two proximal flaps are fixed to each other along the short edge of the pouch by the fastening element and each has a free edge opposite to the short edge of the pouch, which free edge is also the proximal edge of the corresponding fabric sheet. The two proximal flaps can be transformed from a closed state, in which the two free edges of the flaps touch each other or are very close to each other, to an open state, in which the two free edges of the flaps are far away from each other. Each of the proximal flaps has an inner face, which is the surface of the flap that is positioned toward the other flap when in the closed state, and an opposite outer face, which is the surface of the flap that is positioned toward the outside of the device when in the closed state. A collection device provided with such a proximal flap can sample specimens more efficiently because the proximal flap is transformed into the open state by friction with the wall of the body cavity during insertion of the collection device into the body cavity. This makes it possible to collect specimens primarily on the inner face that is usually positioned in the body cavity when the collection device is fully inserted, at the most important area for sampling (usually located near the internal opening of the body cavity). During removal from the body cavity, the proximal flap is transformed back into the closed state, thereby capturing the specimen on the inner face located between the flaps. This ensures that a sufficient amount of specimen is successfully sampled and retained on the inner face of the flap, because only the outer face and the rest of the collection device are wiped due to friction with the wall of the body cavity during removal, so that the specimen is not lost.

[0069] In a preferred embodiment, a flap as described above is provided with any collection device of the present invention.

[0070] In a preferred embodiment, the acquisition device comprises:

[0071] - two fabric sheets, each of which comprises a first segment to be inserted into the body cavity when sampling, wherein both first segments have a substantially similar rectangular shape, wherein the long sides of the rectangle form the lateral edges of the collection device and one of the short sides of the rectangle forms the proximal edge placed at the proximal end of the collection device, the two rectangular first segments being positioned so that they completely overlap each other and being fixed to each other by fastening elements such as spot welding rows and / or continuous welding lines, thereby forming an elongated flat pouch, wherein

[0072] The elongated flat pouch has:

[0073] - an open end, which can be connected to a further segment,

[0074] a short side opposite the open end, said short side being located at a distance of about 1 mm to 10 mm from said proximal edge of the fabric sheet, and

[0075] two long sides, the two long sides being disposed at or near the lateral edges and extending along the length of the lateral edges to the open end;

[0076] At least one of the sheets comprises additional segments which are at least partially retained outside the body cavity during use for grasping and removing the collection device from the body cavity, the additional segments being not fixed to each other, one or both of the additional segments preferably having a distal tip that narrows downwardly towards the distal end of the collection device.

[0077] and

[0078] - two corrugation means, such as threads or elastic threads, each having a fixed end fixed inside the pouch at or near said short edge and a free end extending freely out of the pouch from said open end but not beyond the distal end of said further segment,

[0079] The collecting device is configured so that when the free ends of the two creasing devices are pulled in opposite directions substantially perpendicular to the long sides, the short sides of the pouch are brought closer to the open end, and the pouch takes on a crimped shape.

[0080] The acquisition device of this embodiment has the following advantages:

[0081] - the collecting device can be produced by a simple continuous process: by simultaneously feeding two fabric sheets and two corrugated devices between said two fabric sheets into a machine to form a continuous laminate-like structure and cutting the two fabric sheets and the two corrugated devices at regular intervals into the desired final shape, while simultaneously fixing the two fabric sheets together by welding, thereby forming a pouch and fixing the two corrugated devices,

[0082] - The fact that the short sides of the pouch are located at a distance of about 1 mm to 10 mm from the proximal edge of the fabric sheet has the effect that the two fabric sheets form two proximal flaps towards the proximal end of the collection device, the proximal flaps representing the sections of the two fabric sheets extending from the short sides of the pouch to the proximal edge of each fabric sheet. As described above, a collection device provided with such proximal flaps can sample specimens more effectively, since during the insertion of the collection device into the body cavity, the proximal flaps are transformed into an open state, thereby allowing the specimen to be collected on the inner face of the proximal flaps, and during the removal from the body cavity, the proximal flaps are transformed back into a closed state, thereby capturing the specimen between the flaps. This ensures that a sufficient number of specimens are successfully sampled and retained on the inner face of the flaps, and the specimens are not lost due to the friction of the collection device with the wall of the body cavity during the removal process;

[0083] -The collection device is provided with an additional segment (plural additional segments) which can be retained outside the body cavity and used as a means of removing the collection device from the body cavity. At least one and preferably two additional segments narrow downwardly from the open end of the pouch towards the distal end of the collection device into a V-shape, which makes it easier for the user to see and grasp the free end of the corrugated device and which is more comfortable for the user to wear for a long time outside the body cavity during sampling. In a preferred embodiment, the two fabric sheets have similar additional segments, for example the additional segments are cut out simultaneously in the above-mentioned process. Moreover, the fact that the free end of the corrugated device does not extend beyond the distal end of the additional segment prevents the user from using the corrugated device as the only means of removing the collection device from the body cavity, so that the pouch will not be turned inside out during the removal process.

[0084] Kits

[0085] In another aspect of the present invention, a sampling kit is disclosed, comprising a collection device as described above, an applicator for inserting into a pouch to introduce at least a portion of the collection device into a body cavity, and a sealable receiver for receiving the collection device after sampling.

[0086] The sampling kit may also include marking means, such as a label for writing data of the patient from whom the sample was obtained and / or instructions for using the sampling kit.

[0087] Applicator

[0088] The collection device according to the present invention can be inserted into the body cavity by using an applicator such as a pushing tool. The shape and size of the pushing tool or applicator will have a shape and size suitable for the body cavity for which it is intended to be used and the strength required to push the collection device into the body cavity. The applicator can be disposable (one-time use only) or reusable. The applicator can be made of any suitable material, such as plastic, silicon, wood, metal (such as stainless steel, titanium or gold-plated), cardboard, etc. Preferably, the applicator is made of low-density polyethylene PE-LD, which has low production cost, good flexibility, light weight and can be washed and reused.

[0089] The applicator can be releasably inserted inside the pouch of the collection device. Preferably, the width of the pouch is 1 mm to 6 mm larger than the diameter of the applicator for smooth insertion and removal. Optionally, the applicator can have a gripping area for gripping during insertion of the sampling cloth and during removal of the applicator from the body cavity. The gripping area can have an attachment surface, or can be shaped so that the gripping area can be easily and securely gripped by a human hand. For example, the applicator can have a series of recesses or protrusions along the gripping area.

[0090] For example, the applicator can be made in the form of a tubular body having a proximal end (head) which is the end that first enters the body cavity and a distal end which is the end that remains outside the body cavity and is optionally provided with a gripping device. For use in human vaginal collection devices, such an applicator can have a length of about 120 mm (the height of the tube) and a width (the diameter of the tube) of about 8 to 12 mm (e.g., 10 to 11 mm).

[0091] Sealable receiver

[0092] The receiver of the sampling kit is made of a suitable standard material (e.g., plastic), and is preferably a standardized receiver that is easy to obtain and mass-produce, such as a plastic tube provided with a threaded cap. The receiver has a size suitable for accommodating the collection device of the present invention. Preferably, the size of the receiver is suitable for accommodating the collection device when it is in a wrinkled shape. That is, the receiver can be used in the kit of the present invention, which has a reduced size so that a collection device with a pouch in a wrinkled shape can be introduced, but a collection device with a pouch in an extended shape cannot be introduced therein or may be difficult to introduce, thereby compromising the amount of specimen obtained by sampling and / or contaminating the collection device. The effect of this is that a receiver of smaller size than usual can be used, the receiver is cheaper and requires a smaller amount of preservation liquid.

[0093] The receptacle is provided with at least one opening having a size sufficient to allow a user of the kit to insert a collection device with a pouch in the shape of a corrugation into the receptacle.

[0094] The receptacle is sealable, which means that any opening of the receptacle is provided with a sealing device, thereby ensuring that it can be securely sealed after the collection device is inserted, so as to ensure that its contents cannot be discharged and / or contaminated.

[0095] Optionally, the receiver may contain a medium for preserving the specimen or further preparing the specimen for the required subsequent examination, such as distilled water, saline, culture medium (for bacterial analysis), KOH solution (for fungal analysis), etc. Alternatively, such a medium for preserving or preparing the specimen can be added to the receiver after the specimen arrives at the testing and diagnostic facility (e.g., laboratory). Preferably, the medium for preserving or preparing the specimen can occupy half or less of the volume of the sealable receiver. The pouch is first introduced into the receiver when the user introduces the collection device into the receiver, and the pouch will occupy a small volume at the bottom of the receiver. The receiver is usually kept in an upright position in the testing facility, such as in a tube rack. Therefore, due to the small volume of the wrinkled pouch and its position at the bottom of the receiver, the entire pouch can be immersed in a small volume of the medium for preservation or preparation, thereby ensuring preservation and recovery of the maximum possible amount of specimen from the entire surface of the pouch without using a large amount of the preservation or preparation medium.

[0096] Manufacturing Process

[0097] In another aspect of the present invention, a process for manufacturing a collection device according to a preferred embodiment of the present invention is disclosed.

[0098] The acquisition device of the present invention may be produced by any method suitable for processing one or more suitable fabric sheets together with a creasing device into an acquisition device as discussed above.

[0099] In particular, a process for manufacturing a collection device according to a preferred embodiment of the present invention is disclosed, the process comprising:

[0100] a) two similar fabric sheets and two creasing devices (e.g. two wires) are continuously fed from separate rolls to a fastening and cutting machine so that the fabric sheets and the creasing devices are assembled into a sandwich-like assembly on the production line, wherein the two fabric sheets overlap each other and the creasing device runs between the two fabric sheets;

[0101] b) applying fastening means, such as welding means, such as ultrasonic welding, to the sandwich-like assembly, thereby fastening the two fabric sheets together to form a pouch of the collecting device by fastening elements (e.g. rows of weld points and / or continuous weld lines), while the fastening elements forming the short sides of the pouch also fasten the two corrugated means inside the pouch; and simultaneously

[0102] c) Using a cutting device, the two fabric sheets and the two corrugating devices are cut to obtain the desired final shape of the collecting device.

[0103] By arranging the machine to apply the fastening means and the cutting means simultaneously and repeatedly (e.g. by using a rotating die) to the sandwich-like structure continuously advancing on the production line, the collecting devices are continuously produced during a single pass of the raw material through the machine in an efficient, fast and minimal material waste process. The collecting device thus produced may have: the mentioned two flaps located at the proximal end for more effective sampling; and / or the mentioned additional segment narrowing downwards towards the distal end of the collecting device for a more comfortable fitting of the crimping device and ease of use of the crimping device. Moreover, the mentioned crimping means are cut together with the distal end of the sheet so that the distance between their distal ends and the proximal end of the collecting device is equal to the distance between the distal edge of the additional segment and the proximal end of the collecting device, whereby the crimping means does not protrude for use as a removal device, but can be easily grasped and pulled to crimp the pouch.

[0104] Sampling method

[0105] In another aspect of the present invention, a method for collecting at least one specimen from a body cavity of a human or an animal is disclosed, the method comprising the following steps:

[0106] - inserting at least a portion of the collection device of the present invention into a body cavity of a human or animal;

[0107] - Removing the collection device from the body cavity;

[0108] - simultaneously pulling the two creasing devices by their distal tips in opposite directions away from each other and substantially perpendicular to the long sides of the pouch, thereby creasing the pouch into a crimped shape;

[0109] - placing the collecting device with the pouch in the shape of a corrugation into the sealable receptacle;

[0110] - Sealing receiver;

[0111] -Sending the sealed receiver to a testing facility, such as a laboratory, for testing and diagnosis.

[0112] Depending on the specific conditions (e.g., humidity in the user's body cavity, target specimen, etc.), the collection device of the present invention can be left in the body cavity for a period of time. In a preferred embodiment, in order to collect HPV DNA from a person's vagina, the collection device of the present invention can remain inserted into the vagina for at least 2 minutes, preferably 2 minutes to 30 minutes, for example 2 minutes to 20 minutes or 2 minutes to 15 minutes.

[0113] Preferably, step d) is performed by the user holding the corrugated pouch by the corrugation means and first introducing the pouch therein when introducing the collecting device into the sealable receptacle. The small size and rigidity of the corrugated pouch will allow easy insertion, so that the pouch does not need to be further in contact with the hand, thereby avoiding contamination of the sample and / or the hand. Moreover, the entire pouch, especially its proximal end, such as the proximal flap, will be placed at the bottom of the sealable receptacle, thereby ensuring that the area most likely to have the sampled specimen is inserted into the preservation or preparation liquid, even if the amount of said liquid is small.

[0114] Diagnostic Methods

[0115] In another aspect, a method for diagnosing an STI (sexually transmitted infection) is disclosed, the method comprising the steps of:

[0116] - Self-collect at least one specimen from the body cavity of humans and animals according to the sampling methods described above;

[0117] - Determining the presence of an STI by analyzing and identifying the at least one sample from the collection device. BRIEF DESCRIPTION OF THE DRAWINGS

[0118] Figure 1a A semi-front view of a preferred embodiment according to the invention is shown, wherein the acquisition device is made of two fabric sheets and has a proximal flap and a further section narrowing downwardly into a V-shape.

[0119] Figure 1b A front view of a preferred embodiment in FIG. 1 is shown, wherein the fastening elements along the long sides of the pouch are made of rows of welds placed at an angle to the long sides.

[0120] Figure 1c Shown is a front view of an embodiment in which the fastening elements along the long sides of the pouch are made of a continuous weld line.

[0121] Figure 2a to Figure 2e Views showing steps for crimping a collection device according to an embodiment of the present invention and placing it within a receptacle and sealing the receptacle.

[0122] Figures 3a to 3e A sequential view of some steps of the sampling method according to the present invention is shown using an embodiment in which the collecting device is provided with a proximal flap.

[0123] Figure 4 A view of an embodiment of a collection device without flaps and without additional segments is shown. DETAILED DESCRIPTION

[0124] exist Figure 4A collection device (1) according to one embodiment of the invention is depicted in FIG. The collection device (1) may comprise: for example, a fabric sheet bent along the short side (201) of the pouch (20); or two fabric sheets (40, 41) positioned such that they at least partially cover each other. Figure 4 , a front view of an embodiment is shown, in which two rectangular fabric sheets (40, 41) of substantially similar shape are placed to cover each other so that only one of the fabric sheets (40, 41) is visible in the front view. The fabric sheets (40, 41) each have a proximal edge (401) forming the proximal end (101) of the collection device (1), two lateral edges (402, 404) and a distal edge (403) opposite the proximal edge (401). The two fabric sheets (40, 41) are fixed to each other by a fastening element (25) to form an elongated flat pouch (20). In this embodiment, the fastening means (25) is placed at the proximal edge (401) to form the short side (201) of the pouch (20) and is placed near the lateral edges (402, 404) to form the long side (202, 204) of the pouch (20).

[0125] exist Figure 4 In the embodiment, the two folding devices (32, 34) are shown by dotted lines in the case where the two folding devices are located inside the pouch (20) and are shown by regular lines in the case where the two folding devices extend out of the pouch (20) from the open end (200) of the pouch (20). Each of the two folding devices has a fixed end (301) and a free end (303), the fixed end being fixed at or near the short edge (201) inside the pouch (20), and the free end extending freely from the open end (200). In this embodiment, the folding devices (32, 34) are longer than the two fabric sheets (40, 41), so the folding devices can also be used as a device for removing the collection device (1) from the body cavity. The corrugation means (32, 34) can be pulled by the free end (303) in opposite directions each substantially perpendicular to one of the two long sides (202, 204), thereby sliding along the bending point (302, 304) at the distal end of the long sides (202, 204) of the pouch and bringing the short sides (201) of the pouch closer to the open end (200).

[0126] Figure 1aA preferred embodiment of the collection device (1) of the present invention is shown, wherein the collection device (1) comprises two fabric sheets (40, 41), each of which comprises a first segment (50, 51) that enters a body cavity when in use. In this embodiment, the two first segments (50, 51) have a substantially rectangular similar shape, wherein the long sides of the rectangle form lateral edges (502, 504), and one of the short sides of the rectangle forms a proximal edge (500, 501), which is placed at the proximal end (101) of the collection device (1), and the two first segments (50, 51) are positioned so that they overlap each other and are fixed to each other by a fastening element (25) to form an elongated flat pouch (20). The fastening element (25) forms a rectangular three-sided outline bordering a rectangular elongated flat pouch (20) having an open end (200) continuous with a further segment (60, 61); a short side (201) opposite the open end (200) and located at a distance of about 1 mm to 10 mm from the proximal edge (500, 501); and two long sides (202, 204) disposed along the lateral edges (502, 504) and running along the length of the lateral edges (502, 504) until the open end (200). Since the short sides (201) of the pouch (20) are located at a distance of about 1 mm to 10 mm from the proximal edge (500, 501), the two fabric sheets (40, 41) form two symmetrical proximal flaps (44, 46) at the proximal end (101). The flaps (44, 46) are attached to each other along the short edge (201) by fastening elements (25) and each has a free edge opposite the short edge of the pouch, which is also the edge (500, 501) of the respective fabric sheet (40, 41). The two proximal flaps (44, 46) are depicted in a closed state, wherein their two free edges (500, 501) are very close to each other.

[0127] Each of the fabric sheets (40, 41) comprises a further segment (60, 61) which is at least partially retained outside the body cavity during use for grasping the collection device (1) and removing the collection device from the body cavity, the further segments (60, 61) not being fixed to each other. Both further segments (60, 61) have a V-shaped distal tip (603) which narrows towards the distal end (103) of the collection device (1).

[0128] exist Figure 1aIn the embodiment of the present invention, the two corrugations (32, 34) are shown by dashed lines in the case where they are located inside the pouch (20), and by regular lines in the case where they protrude from the pouch (20). Each of the two corrugations has a fixed end (301) fixed at the short edge (201) inside the pouch (20) and a free end (303) protruding freely from the open end (200) and reaching approximately the same length as the distal end (603) of the further segment (60, 61).

[0129] Figure 1b Depicted Figure 1a A front view of a collection device (1) of the type shown in FIG. 1, wherein only one fabric sheet (40, 41) is visible and none of the corrugated elements (32, 34) are visible. In this embodiment, the fastening elements (25) forming the long sides (202, 204) of the pouch (20) are a single straight row of welds (7). Each weld (7) has a substantially elongated shape having a long axis (70), a proximal end (71) and a distal end (73). In this preferred embodiment, the elongated welds (7) are arranged in corresponding rows such that the long axis (70) of each weld forms a similar angle (700) with the direction of the corresponding row of welds. The angle (700) is the acute angle formed by the long axis (70) of the weld and the direction of the corresponding long side (202, 204) towards the proximal end (101) of the collection device (1). Thus, the proximal end (71) of each weld (7) is simultaneously closer to the short side (201) of the pouch and the longitudinal center axis (210) of the pouch (20). The effect of this arrangement is that when the creasing means (32, 34) are pulled, the angled welds (7) guide the pouch to fold into small, uniform, regular, symmetrical creasings, thereby presenting a compact, creasing shape that is more easily introduced into a receptacle.

[0130] Furthermore, in this preferred embodiment, the fastening element (25) forming the short side (201) of the pouch (20) is made of two rows of welding points (7) and a continuous welding line between the two rows. Such a fastening element (25) is more resistant to the forces applied by the applicator (8) and also ensures that each of the corrugated means (32, 34) is fixed at at least one point.

[0131] Figure 1c A front view of an embodiment is depicted in which only one fabric sheet (40, 41) is visible and none of the corrugated elements (32, 34) are visible. In this embodiment, the fastening elements (25) forming the long sides (202, 204) of the pouch (20) are a single straight row of continuous welds.

[0132] Figure 2a to Figure 2eViews showing steps for crimping a collecting device (1) according to an embodiment of the invention and placing the collecting device in a sealable receptacle (9) and sealing said receptacle (9).

[0133] Figure 2a It is shown how the harvesting device (1) removed from the body cavity is grasped by the free end (303) of the corrugation means (32, 34).

[0134] Figure 2b and Figure 2c It is shown how, by pulling the free ends (303) of the corrugating means (32, 34) in opposite directions, each direction being substantially perpendicular to one of the two long sides (202, 204), the short sides (201) of the pouch are brought closer to the open end (200), while the pouch (20) assumes a gradually contracting shape until the pouch reaches Figure 2c The corrugated shape (22) is shown.

[0135] Figure 2d It is shown how a collection device (1) with a pouch (2) in a corrugated shape (22) is held by corrugated means (32, 34) and introduced into a sealable receptacle (9), which is a test tube with a screw cap. The small size and rigidity of the pouch (20) in a corrugated shape (22) allow easy insertion, so that the pouch does not need to come into further contact with the hand, thereby avoiding contamination of the sample and / or the hand.

[0136] Figure 2e The receiver (9) is shown after the collecting device (1) has been inserted and the threaded cap has been closed, thereby sealing the receiver (9).

[0137] Figures 3a to 3e A sequential view of some steps of the method for sampling according to the present invention is shown using an embodiment in which the collecting device (1) is provided with proximal flaps (44, 46) and is inserted into the vaginal cavity.

[0138] Figure 3a The collecting device (1) as shown in Figure 1 is shown, wherein the applicator (8) is introduced into the pouch (20), which is ready to be inserted into the vaginal cavity (30). It can be seen that most of the length of the applicator (8) is covered by the collecting device (1), thus protecting the vaginal mucosa from direct contact with the applicator (8).

[0139] Figure 3b The collecting device (1) is shown positioned at the entrance of the vaginal cavity for insertion. It can be seen that the two symmetrical proximal flaps (44, 46) of the collecting device are in a closed state, wherein their two free edges (500, 501) are in contact or very close to each other.

[0140] Figure 3c The proximal end (101) of the collection device (1) after insertion into the vaginal cavity is shown. It can be seen that the two flaps (44, 46) have been transformed into an open state during the insertion process, wherein the two free edges (500, 501) of the flaps are away from each other and the inner surface (47) of the flaps is positioned to receive specimens from the endocervical canal and the cervical os.

[0141] Figure 3d The proximal end (101) of the collection device (1) is shown during removal from the vaginal cavity. It can be seen that due to the direction of removal, the proximal flaps (44, 46) are transformed back into a closed state, thereby capturing the specimen on the inner surface (47) of the flaps between the flaps (44, 46). This ensures that a sufficient amount of the specimen is successfully sampled and retained on the inner surface (47) of the flaps (44, 46), and the specimen is not lost due to friction between the collection device (1) and the vaginal wall during removal.

[0142] Figure 3e The collecting device (1) is shown after removal from the vaginal cavity. It can be seen that the collecting device has been removed by using the further segments (60, 61) as a removal device. It can also be seen that the flaps (44, 46) remain in a closed state during removal.

Claims

1. A collection device (1), the collection device being used to collect at least one specimen from a body cavity of a human or an animal, The collecting device has a proximal end (101) and a distal end (103) opposite to the proximal end, wherein the proximal end is the end of the collecting device that first contacts the body cavity during use. The collection device comprises: - an elongated flat pouch (20) having: an open end (200); a short side (201) opposite to the open end (200), the short side being located at the proximal end (101) of the collecting device (1); as well as Two long sides (202, 204); Characterized in that the collection device also includes: - two corrugation means (32, 34), each of said corrugation means having a fixed end (301) fixed inside said pouch (20) at or near said short edge (201) and a free end (303) extending freely through said open end (200), The collecting device (1) is configured such that when the free ends (303) of the two wrinkling devices (32, 34) are pulled in opposite directions, the short side (201) of the pouch (20) is brought closer to the open end (200), and the pouch (20) presents a wrinkled shape (22), each of the opposite directions being substantially perpendicular to one of the two long sides (202, 204), and - two proximal flaps (44, 46) extending from the short side (201) towards the proximal end (101) of the collecting device, the two proximal flaps being fixed to each other along the short side and each having a free edge opposite to the short side, wherein the two proximal flaps are capable of transitioning from a closed state to an open state, in which the two free edges of the proximal flaps touch or approach each other, and in which the two free edges of the proximal flaps are away from each other, and wherein each of the proximal flaps has an inner face and an opposite outer face. The inner surface is a surface that is positioned toward the other proximal flap when the proximal flap is in the closed state, and the opposite outer surface is a surface that is positioned toward the outside of the collection device when the proximal flap is in the closed state, so that during the insertion of the collection device into the body cavity, the proximal flap is transformed into the open state by friction with the body cavity wall, which allows the specimen to be collected mainly on the inner surface, and during the removal from the body cavity, the proximal flap is transformed back to the closed state, thereby capturing the specimen between the proximal flaps on the inner surface of the proximal flap.

2. The collection device (1) according to claim 1, characterized in that: The pouch (20) is made of a flexible fabric suitable for collecting at least one specimen.

3. The collection device (1) according to claim 2, characterized in that: The at least one sample is a cell, a cell residue, DNA, RNA, a protein, a virus, a bacterium, a parasite, or a fungus.

4. The collection device (1) according to claim 2, characterized in that: The flexible fabric has a water absorbency of 3.5 g / g or less.

5. The collection device (1) according to claim 2, characterized in that: The collecting device (1) further comprises at least one additional segment (60, 61), which is integrally formed with the fabric of the pouch (20), and which extends from the open end (200) of the pouch (20) toward the distal end (103) of the collecting device (1), and which has a size such that after the collecting device (1) is inserted into the body cavity, the at least one additional segment (60, 61) protrudes out of the body cavity.

6. The collection device (1) according to any one of claims 1 to 5, characterized in that: Each of the corrugated means (32, 34) is in the form of a wire, a cord, or a strip.

7. The collection device (1) according to any one of claims 1 to 5, characterized in that: The collecting device (1) comprises two fabric sheets (40, 41), each of the fabric sheets having a proximal edge (401) located at the proximal end (101) of the collecting device (1), a distal edge (403) located at the distal end (102) of the collecting device (1), and two lateral edges (402, 404), wherein the fabric sheets (40, 41) are fixed to each other by fastening elements (25) to form the short side (201) and the two long sides (202, 204) of the pouch (20).

8. The collection device (1) according to claim 7, characterized in that: The fastening elements (25) are continuous weld lines, rows of spot welds, stitching lines and / or glue lines.

9. The collection device (1) according to claim 7, characterized in that: The two long sides (202, 204) of the pouch (20) are parallel to each other and perpendicular to the short side (201).

10. The collection device (1) according to claim 7, characterized in that: The short side (201) of the pouch (20) is located at a distance of 1 mm to 10 mm from the proximal edge (401) of the fabric sheet (40, 41).

11. The collection device (1) according to claim 10, characterized in that: The short side (201) of the pouch (20) is located at a distance of 1 mm to 3 mm from the proximal edge (401) of the fabric sheet (40, 41).

12. The collection device (1) according to claim 10, characterized in that: The short side (201) of the pouch (20) is located at a distance of 1 mm to 5 mm from the proximal edge (401) of the fabric sheet (40, 41).

13. The collection device (1) according to claim 10, characterized in that: The short side (201) of the pouch (20) is located at a distance of 1 mm to 8 mm from the proximal edge (401) of the fabric sheet (40, 41).

14. The collection device (1) according to claim 7, characterized in that: The proximal flaps are secured to each other at one end by the fastening element (25) at the short edge (201).

15. The collection device (1) according to claim 7, characterized in that: The long sides (202, 204) of the pouch (20) are located at or near the lateral edges (402, 404) of the fabric sheets (40, 41).

16. The collection device (1) according to claim 7, characterized in that: The fastening elements (25) at the short sides (201) of the pouch (20) are made of two or more rows of welding points (7) and / or a continuous welding line.

17. The collection device (1) according to claim 7, characterized in that: Each fabric sheet (40, 41) has a segment (50, 51) secured to the other fabric sheet (41, 40) to form the pouch (20) and at least one of the fabric sheets (40, 41) has an unsecured further segment (60, 61) at the distal edge (403).

18. The collection device (1) according to claim 17, characterized in that: At least one of the further segments (60, 61) has a V-shape which narrows towards the distal end (103) of the collecting device (1).

19. The collection device (1) according to claim 17 or 18, characterized in that: The free end (303) of each of the corrugations (32, 34) is capable of extending out of the pouch (20) to a point at least 10 mm beyond the open end (200) of the pouch (20) but not beyond the distal end (603) of the further segment (60, 61).

20. The collection device (1) according to claim 7, characterized in that: The fastening elements (25) forming the two long sides (202, 204) of the pouch (20) are a single straight row of welding points (7), the single straight row of welding points having a substantially elongated shape, each of the shapes defining a long axis (70), a proximal end (71) and a distal end (73), the shape being oriented so that the long axis (70) of each welding point (7) forms an angle (700) with the corresponding long side (202, 204), the welding point being part of the corresponding long side so that the proximal end (71) closer to the short side (201) of the pouch (20) is also the end of the welding point (7) closer to the longitudinal center axis (210) of the pouch (20), so that the long axis (70) forms an acute angle with the direction toward the proximal end (101) of the corresponding long side (202, 204).

21. The collection device (1) according to any one of claims 1 to 5, characterized in that: Each of the corrugation means (32, 34) is in the form of an elastic thread.

22. The collection device (1) according to any one of claims 1 to 5, characterized in that: Each of the corrugating means (32, 34) is in the form of a belt.

23. A sampling kit, comprising a collection device (1) according to any one of claims 1 to 22, an applicator (8) for being inserted into the pouch (20) to introduce at least a portion of the collection device (1) into a body cavity, and a sealable receiver (9) for receiving the collection device (1) after sampling.

24. A method for manufacturing a collecting device (1) according to any one of claims 7 to 22, the method comprising: -a) feeding two identical fabric sheets (40, 41) and two creasing devices (32, 34) continuously from separate rolls to a fastening and cutting machine so that the fabric sheets and the creasing devices are assembled into a sandwich-like assembly on a production line, wherein the two fabric sheets (40, 41) overlap each other and the two creasing devices (32, 34) run between the two fabric sheets (40, 41); -b) applying fastening means to the sandwich-like assembly, thereby fastening the two fabric sheets (40, 41) together by means of the fastening elements (25) to form the pouch (20) of the collecting device (1), while the fastening elements (25) forming the short sides (201) of the pouch (20) also fasten the two corrugated means (32, 34) inside the pouch (20); and at the same time -c) applying a cutting device to simultaneously cut said two fabric sheets (40, 42) and said two corrugating devices (32, 34) to obtain the desired final shape of said collecting device.

25. The method according to claim 24, characterized in that The fastening means is a welding means.

26. The method according to claim 25, characterized in that The welding device is an ultrasonic welding device.

Images