Collecting Device, Kit, Manufacturing Process, Sampling Methods and Use

Abstract

The present invention relates to a collecting device (1) for sampling at least one specimen from bodily cavities of humans and animals, comprising: an elongated flattened pouch (20) having: an open end (200), a top side (201) opposed to the open end (200), situated at a proximal end (101) of the collecting device (1), and two lateral sides (202, 204); andtwo creasing means (32, 34), each having a fixed end (301), which is fixed inside the pouch (20) at or in the vicinity of said top side (201) and a free end (303), which protrudes freely through said open end (200), configured such that upon pulling the free ends (303) of the two creasing means (32, 34) in opposite directions, the short side (201) of the pouch (20) is brought closer to the open end (200) while the pouch (20) adopts a creased shape (22). Preferably, the collecting device further comprises two sheets of fabric (40, 41), that are fastened to each other by fastening elements (25) such as welding lines situated at a distance of about 1 mm to 10 mm from proximal margins (401) of said sheets (40, 41) to form two proximal flaps (44, 46) fixed to each other by the fastening elements (25) such that the two flaps (44, 46) can transition form a closed state (47) to an open state (49). The present invention also relates to the use of the collecting device (1) for sampling of at least one specimen from bodily cavities of humans and animals, to a kit and methods for sampling and to a process for producing the collecting device (1).

Claims

1. Collecting device (1) for sampling at least one specimen from bodily cavities of humans and animals, having a proximal end (101), which is the end of the device to first contact said bodily cavity during use and a distal end (103) opposed to said proximal end comprising: an elongated flattened pouch (20) having: an open end (200) a short side (201) opposed to the open end (200), situated at the proximal end (101) of the collecting device (1), and two long sides (202,204); and two creasing means (32,34), each having a fixed end (301), which is fixed inside the pouch (20) at or in the vicinity of said short side (201) and a free end (303), which protrudes freely through said open end (200), wherein the collecting device (1) is configured such that upon pulling the free ends (303) of the two creasing means (32,34) in opposite directions each substantially perpendicular to one of the two long sides (202,204), the short side (201) of the pouch (20) is brought closer to the open end (200) while the pouch (20) adopts a creased shape (22).

2. Collecting device (1) according to claim 1 wherein the pouch (20) is made of a flexible fabric suitable for collecting at least one specimen such as a cell, cell residue, DNA, RNA, protein, virus, bacterium, parasite, or fungus, such as a fabric with an absorbency of 3.5 g/g or less.

3. Collecting device (1) according to claim 2, wherein the device (1) further comprises at least one further segment (60, 61) integrally formed with the fabric of the pouch (20), extending from the open end (200) of the pouch (20) towards the distal end (103) of the collecting device (1), having dimensions such that, after the collecting device (1) is inserted into the bodily cavity, said at least one further segment (60,61) protrudes outside said bodily cavity.

4. Collecting device (1) according to claims 1-3, wherein each of said creasing means (32,34) is in the form of a thread, elastic thread, string, strip or ribbon.

5. Collecting device (1) according to claims 1-4, wherein the collecting device (1) comprises two sheets of fabric (40,41), each having a proximal margin (401) situated at the proximal end (101) of the device (1), a distal margin (403) situated at the distal end (102) of the device (1), and two lateral margins (402,404), wherein the sheets (40,41) are fastened to each other by fastening elements (25) such as continuous welding lines, spot welding rows, sewing lines, and/or glue lines to form the short side (201) and the two long sides (202,204) of the pouch (20).

6. Collecting device (1) according to claim 5, wherein said two long sides (202,204) of the pouch (20) are parallel to each other and perpendicular to said short side (201).

7. Collecting device (1) according to claims 5-6, wherein said short side (201) of the pouch (20) is situated at a distance of about 1 mm to 10 mm, such as 1 mm to 10 mm, such as 1 to 3 mm, 1 to 5 mm, 1 to 8 mm from the proximal margin (401) of said sheets (40,41).

8. Collecting device (1) comprising two sheets of fabric (40,41), each having a proximal margin (401) situated at a proximal end (101) of the device (1), a distal margin (403) situated at a distal end (102) of the device (1), wherein said sheets (40,41) are fastened to each other by fastening elements (25) such as continuous welding lines, spot welding lines, sewing lines, and/or glue lines to form a pouch (20) having an open end (200), a short side (201) opposed to the open end (200) and situated toward the proximal end (101) of the collecting device (1), and two lateral sides (202,204), wherein said short side (201) of the pouch (20) is situated at a distance of about 1 mm to 10 mm, more preferably 1 to 3 mm, 1 to 5 mm or 1 to 8 mm from the proximal margins (401) of said sheets (40,41), forming two proximal flaps (44,46) fixed to each other at one end by the fastening elements (25) at the short side (201) and having the opposite end free.

9. Collecting device (1) according to claims 5-8, wherein said long sides (202,204) of the pouch (20) are situated at or in the vicinity of the lateral margins (402, 404) of the sheets (40,41).

10. Collecting device (1) according to claims 5-9, wherein the fastening elements (25) at the short side (201) of the pouch (20) are made of two or more rows of welding spots (7) and/or lines of continuous welding.

11. Collecting device (1) according to claims 5-10, wherein each sheet of fabric (40,41) has a segment (50,51) that is fastened to the other sheet (41,40) to form the pouch (20) and at least one of said sheets of fabric (40, 41) has further segment (60,61), at the distal margin (403), that is not fastened.

12. Collecting device (1) according to claim 11, wherein at least one of said further segments (60,61) has a V-shape that narrows toward the distal end (103) of the collecting device (1).

13. Collecting device (1) according to claims 11-12, wherein the fee end (303) of each of said creasing means (32,34) can reach out of the pouch (20) to a point that is at least 10 mm beyond said open end (200) of the pouch (20), but not beyond a distal termination (603) of the further segments (60,61).

14. Collecting device (1) according to claims 5-13, wherein said fastening elements (25) forming the two long sides (202, 204) of the pouch (20) are single straight rows of welding spots (7) having substantially elongated shapes each defining a long axis (70), a proximal end (71) and a distal end (73), oriented so that said long axis (70) of each welding spot (7) forms an angle (700) to the corresponding long side (202,204) that it is part of, such that the proximal end (71) that is closer to the short side (201) of the pouch (20) is also the end of the spot (7) that is closer to a longitudinal central axis (210) of the pouch (20), thus the long axis (70) forming an acute angle to the direction toward the proximal end (101) of the corresponding long side (202,204).

15. Collecting device (1) according to claim 5, having a proximal end (101), which is the end of the device to first contact said bodily cavity during use and a distal end (102) opposed to said proximal end, comprising: two sheets of fabric (40, 41), each comprising a first segment (50,51) that enters the bodily cavity when in use, wherein the two first segments (50,51) have substantially rectangular similar shapes, with the long sides of the rectangles forming lateral margins (502,504), and one of the short sides of the rectangle forming proximal margins (500,501) that are placed at the proximal end (101) of the collecting device (1), the two first segments (50,51) being positioned such that they cover each other, and are fastened to each other by fastening elements (25) such as welding lines, to form an elongated flattened pouch (20), wherein: said elongated flattened pouch (20) has: an open end (200) that can continue with a further segment (60,61), a short side (201) opposed to the open end (200), situated at a distance of about 1 mm to 10 mm from said proximal margins (500,501), and two long sides (202,204) placed at or in the vicinity of the lateral margins (502,504) and running along the length of the lateral margins (502,504) up to the open end (200); at least one of the sheets (40,41) comprising a further segment (60,61) which remains at least partially outside the bodily cavity during use, for gripping and removing the collecting device (1) from the bodily cavity, said further segments (60,61) not being fastened to each other, one or both of said further segments (60,61) preferably having a distal termination (603) with a shape that narrows toward the distal end (103) of the collecting device (1). and two creasing means (32,34), each having a fixed end (301), which is fixed inside the pouch (20) at or in the vicinity of said short side (201), and a free end (303), which protrudes freely through said open end (200), but does not go beyond the distal termination (603) of said further segments (60, 61), wherein the collecting device (1) is configured such that upon pulling the free ends (303) of the two creasing means (32,34) in opposite directions, substantially perpendicular to the long sides (202,204), the short side (201) of the pouch (20) is brought closer to the open end (200) while the pouch (20) adopts a creased shape (22).

16. Use of a collecting device (1) according to any preceding claim for sampling of at least one specimen from bodily cavities of humans or animals such as vaginal cavity, rectal cavity, or cavity or nasal cavity.

17. Sampling kit, comprising a collecting device (1) according to any of the preceding claims, an applicator (8) for inserting into the pouch (20) to introduce at least part of said collecting device (1) inside a bodily cavity, and a sealable recipient (9) for receiving the device (1) after sampling.

18. Method for sampling at least one specimen from bodily cavities of humans or animals comprising the steps: a) inserting at least part of the collecting device (1) according to any of claims 1 to 18 into a bodily cavity of a human or animal, b) removing the collecting device (1) from the bodily cavity, c) pulling said two creasing means (32,34) by their distal extremities (303), at the same time, in opposite directions, away from each other and substantially perpendicular to the long sides (202,204) of the pouch (20), thereby creasing the pouch into a creased shape (22), d) placing the collecting device (1) with the pouch (20) in creased shape (22) inside a sealable recipient (9) e) sealing the recipient (9), f) sending the sealed recipient (9) to a testing facility, such as a laboratory, for testing and/or diagnostic.

19. Method for sampling according to claim 21, wherein after step a) and before step b), the pouch (20) is left inserted into the bodily cavity for a period of time of at least 2 minutes, preferably for 2 to 30 minutes, such as 2 to 15 minutes.

20. A process for manufacturing a collecting device (1) according to claims 4-14, the process comprising: a) continuously feeding to a fastening and cutting machine, from separate coils, two similar sheets of fabric (40,41) and two creasing means (32,34), for example two threads, such that they assemble on a manufacturing line in a sandwich-like assembly with the two sheets of fabric (40,41) covering each other and the two creasing means (32,34) running along between said two sheets of fabric (40, 41); b) applying fastening means to said sandwich-like assembly, for example welding means, such as ultrasound welding, thus fastening said two sheets of fabric (40,41) together by fastening elements (25) such as rows of welding spots and/or lines of continuous welding to form the pouch (20) of the collecting device (1) while at the same time the fastening elements (25) forming the short side (201) of the pouch (20) also fix the two creasing means (32,34) inside the pouch (20), and simultaneously c) applying cutting means to cut at the same time the two sheets of fabric (40,42) and the two creasing means (32,34) to obtain the desired final shape of the collecting device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0095] FIG. 1 a represents a semi-frontal view of a preferred embodiment according to the invention wherein the collecting device is made of two sheets of fabric and has proximal flaps and further sections that narrow down into a V-shape

[0096] FIG. 1b represents a frontal view of the preferred embodiment in FIG. 1, wherein the fastening elements along the long sides of the pouch are made of rows of welding spots placed at an angle to the long sides.

[0097] FIG. 1c represents a frontal view of an embodiment wherein the fastening elements along the long sides of the pouch are made of continuous welding lines.

[0098] FIGS. 2a to 2e represent views of the steps for creasing and placing a collecting device according to an embodiment of the invention within recipient, and sealing said recipient.

[0099] FIGS. 3a to 3e represent sequential views of some steps of the method for sampling according to the invention, with an embodiment wherein the collecting device is provided with proximal flaps.

[0100] FIG. 4 represents a view of one embodiment of the collecting device without flaps and without further segments.

EXAMPLES

[0101] The collecting device (1) according to one embodiment of the invention is depicted in FIG. 4. The collecting device (1) may comprise, for example, one sheet of fabric bended along the short side (201) of the pouch (20), or two sheets of fabric (40, 41), positioned such that they cover each other at least partially. In FIG. 4 it is shown a front view of an embodiment wherein two sheets of fabric (40, 41) having substantially rectangular similar shapes are placed to cover each other, such that only one of the sheets (40,41) is visible in this front view. Said sheets of fabric (40,41) each have a proximal margin (401) that forms the proximal end (101) of the collecting device (1), two lateral margins (402,404) and a distal margin (403) opposite said proximal margin (401). The two sheets (40,41) are fastened to each other by fastening elements (25), to form an elongated flattened pouch (20). In the present embodiment, the fastening means (25) are placed at the proximal margin (401) to form the short side (201) of the pouch (20) and in the vicinity lateral margins (402,404) to form the long sides (202,204) of the pouch (20).

[0102] The two creasing means (32,34) are represented in FIG. 4 by dotted lines where they are inside the pouch (20), and by regular lines where they protrude from the pouch (20) through the open end (200) of the pouch (20). Each of the two creasing means has a fixed end (301), which is fixed inside the pouch (20) at or in the vicinity of the short side (201), and a free end (303), which protrudes freely through said open end (200). In the present embodiment, the creasing means (32,34) are longer than the two sheets of fabric (40,41), so they can be used also as means for removal of the collecting device (1) from the bodily cavity. The creasing means (32,34) can be pulled by said free ends (303) in opposite directions each substantially perpendicular to one of the two long sides (202,204), thus sliding along bending points (302, 304) at the distal extremities of the long sides (202, 204) and bringing the short side (201) of the pouch closer to the open end (200).

[0103] FIG. 1a depicts a preferred embodiment of the collecting device (1) of the present invention, wherein the collecting device (1) comprises two sheets of fabric (40, 41), each comprising a first segment (50,51) that enters the bodily cavity when in use. In this embodiment, the two first segments (50,51) have substantially rectangular similar shapes, with the long sides of the rectangles forming lateral margins (502,504), and one of the short sides of the rectangle forming proximal margins (500,501) that are placed at the proximal end (101) of the collecting device (1), the two first segments (50,51) being positioned such that they cover each other, and are fastened to each other by fastening elements (25), to form an elongated flattened pouch (20). The fastening elements (25) form the contour of three sides of a rectangle, bordering a rectangular elongated flattened pouch (20) having an open end (200) that continues with further segments (60,61), a short side (201) opposed to the open end (200), situated at a distance of about 1 mm to 10 mm from said proximal margins (500,501), and two long sides (202,204) placed along the lateral margins (502,504) and running along the length of the lateral margins (502,504) up to the open end (200). By the fact that the short side (201) of the pouch (20) is situated at a distance of about 1 mm to 10 mm from said proximal margins (500,501), the two sheets of fabric (40, 41) form at the proximal end (101) two symmetrical proximal flaps (44, 46). Said flaps (44,46) are attached to each other by the fastening elements (25) along the short side (201) and have each a free margin opposite the short side of the pouch that is also the margin (500, 501) of the respective sheet of fabric (40,41). The two proximal flaps (44,46) are depicted in a closed state, wherein their two free margins (500,501) are very close to each other.

[0104] Each of the sheets (40,41) comprises a further segment (60,61) which remains at least partially outside the bodily cavity during use, for gripping and removing the collecting device (1) from the bodily cavity, said further segments (60,61) not being fastened to each other. Both further segments (60,61) have a distal termination (603) with a V-shape that narrows toward the distal end (103) of the collecting device (1).

[0105] The two creasing means (32,34) are represented in FIG. 1a by dotted lines where they are inside the pouch (20), and by regular lines where they protrude from the pouch (20). Each of the two creasing means has a fixed end (301), which is fixed inside the pouch (20) at the short side (201), and a free end (303), which protrudes freely through said open end (200), and reaches to about the same length as the distal termination (603) of said further segments (60, 61).

[0106] FIG. 1b depicts a front view of the collecting device (1) of FIG. 1 a, wherein only one of the sheets of fabric (40,41) is visible, and none of the creasing elements (32,34). In this embodiment, the fastening elements (25) forming the long sides (202,204) of the pouch (20) are single straight rows of welding spots (7). Each welding spot (7) has a substantially elongated shape with a long axis (70), a proximal end (71) and a distal end (73). In the present, preferred embodiment, the elongated welding spots (7) are placed in the corresponding rows such that the long axes (70) of each welding spot forms a similar angle (700) to the direction of their corresponding row. The angle (700) is an acute angle formed by the long axes (70) of the welding spots to the direction of the corresponding long side (202,204) toward the proximal end (101) of the collecting device (1). Therefore, the proximal end (71) of each welding spot (7) is at the same time closer to the short side (201) of the pouch and to a longitudinal central axis (210) of the pouch (20). This arrangement has the effect that, when pulling on the creasing means (32,34), the angled welding spots (7) lead the pouch to fold into small, even, regular, symmetric creases, thus adopting a compact creased shape that is easier to introduce into a recipient.

[0107] Moreover, in the present preferred embodiment, the fastening elements (25) forming the short side (201) of the pouch (20) are made of two rows of welding spots (7) and a line of continuous welding placed between the two rows. Such fastening element (25) is more resistant to the force exerted by the applicator (8) and also ensures that each of the creasing means (32,34) is fixed in at least one point.

[0108] FIG. 1c depicts a front view of an embodiment wherein only one of the sheets of fabric (40,41) is visible, and none of the creasing elements (32,34). In this embodiment, the fastening elements (25) forming the long sides (202,204) of the pouch (20) are single straight rows of continuous welding.

[0109] FIGS. 2a-2e represents views of the steps for creasing and placing a collecting device (1) according to an embodiment of the invention within a sealable recipient (9), and sealing said recipient (9).

[0110] FIG. 2a shows how the collecting device (1) that has been removed from the bodily cavity is gripped by the free ends (303) of the creasing means (32,34).

[0111] FIGS. 2b and 2c show how, by pulling on said free ends (303) of the creasing means (32,34) in opposite directions each substantially perpendicular to one of the two long sides (202,204), the short side (201) of the pouch is brought closer to the open end (200) while the pouch (20) adopts an increasingly contracted shape until it reaches a creased shape (22) shown in FIG. 2c.

[0112] FIG. 2d shows how the collecting device (1) having the pouch (2) in creased shape (22) is held by the creasing means (32,34) and introduced into the sealable recipient (9), which is a testing tube with a thread cap. The small dimensions and rigidity of the pouch (20) in creased shape (22) allow for an easy insertion, such that no further contact of the pouch with the hand is necessary, thus avoiding the contamination of the sample and/or of the hands.

[0113] FIG. 2e shows the recipient (9) after the collecting device (1) has been inserted and the thread cap has been closed, thus sealing the recipient (9).

[0114] FIGS. 3a to 3e represent sequential views of some steps of a method for sampling according to the invention, with an embodiment wherein the collecting device (1) is provided with proximal flaps (44,46) and is inserted inside a vaginal cavity.

[0115] FIG. 3a shows a collecting device (1) as depicted in FIG. 1 with the applicator (8) introduced into the pouch (20), ready for insertion inside the vaginal cavity (30). It can be seen that most of the length of the applicator (8) is covered by the collecting device (1), so the vaginal mucosa is protected from direct contact with the applicator (8).

[0116] FIG. 3b shows the collecting device (1) as it is 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 closed state, wherein their two free margins (500,501) touch or are very close to each other.

[0117] FIG. 3c shows the proximal end (101) of collecting device (1) after insertion into the vaginal cavity. It can be seen that the two flaps (44,46) have transitioned during insertion an open state, wherein their two free margins (500,501) get away from each other and their inner faces (47) are positioned to receive specimens from the endocervical canal and cervical os.

[0118] FIG. 3d shows the proximal end (101) of collecting device (1) during removal from the vaginal cavity. It can be seen that, due to the direction of removal, the proximal flaps (44,46) transition back to the closed state, thus catching the specimens on their inner faces (47) between the flaps (44,46). This ensures that a sufficient amount of specimens are successfully sampled and kept on the inner faces (47) of the flaps (44,46), which are not lost due to the friction of the collecting device (1) with the walls of the vaginal cavity during removal.

[0119] FIG. 3e shows the collecting device (1) 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 removal means. It is also vicible that the flaps (44,46) have remained in closed state during removal.