DEVICE FOR COLLECTING A CHEST SAMPLE FROM A LIVING BEING

Description

[0001] The present invention relates to a device for collecting a stool sample from a living being, in particular a human being, comprising a hollow base body having a circumferential wall and being open at its upper and lower end faces, and a collection bag open at the top, which forms a receiving chamber for a stool sample and is attached to the base body in such a way that a stool sample emerging from the bottom of the base body can be received in the collection bag, wherein a filter chamber is formed in the lower end region of the collection bag, which is separated from the receiving chamber by a leaf-shaped filter element.

[0002] Trillions of bacteria live in the human gut. Several hundred different species colonize the large intestine in particular, forming what is known as the microbiome. These bacteria are not only important for the human immune system but are also responsible for the digestion of dietary fiber. They produce enzymes that break down these food components, which are otherwise indigestible for us. They also defend against pathogens and produce vitamins.

[0003] It is known that the composition of the microbiome depends on many different factors, including each individual's lifestyle. Shifts and imbalances in the composition of the gut flora can cause allergies, a predisposition to obesity, and other illnesses. Therefore, a healthy, balanced gut flora is important for everyone's health.

[0004] Therefore, the gut and its bacterial flora have attracted increasing interest in recent years, particularly in the context of treating chronic inflammatory bowel diseases. When the gut is infected with bacteria, for example, with inflammation of the intestinal wall caused by the toxins of the bacterium Clostridioides difficile, treatment typically involves antibiotics. However, a problem arises because these antibiotics do not distinguish between beneficial bacteria in the gut and those that cause the inflammation being treated. This results in a general die-off of bacteria in the patient's gut, and harmful Clostridia often proliferate in the spaces left by the dead beneficial bacteria. Inflammation of the intestine frequently follows, sometimes progressing to pseudomembranous colitis, accompanied by persistent diarrhea.Therefore, after prolonged treatment with antibiotics, the rebuilding of the intestinal flora is regularly accompanied by medication and / or probiotic foods.

[0005] An alternative treatment for symptomatic Clostridioides difficile infections, used for several years and approved in Germany since mid-2016, involves fecal microbiota transplantation (FMT). In this procedure, stool from healthy donors is transferred into the intestines of patients. The intestinal flora is transferred from one person to another, a process described using various terms. In English, the term "fecal microbiota transplantation" is most commonly used.

[0006] Furthermore, there are newer efforts to perform autologous fecal microbiota transplantation (AFM). This means that, particularly before antibiotic treatment, stool samples are taken from a patient and then stored long-term in order to reintroduce the microorganisms they contain into the patient's intestine after the antibiotic treatment. Given these therapeutic options, there is a need for a simple and hygienic method of collecting and storing a human stool sample. Devices of the type mentioned above are known, for example, from WO 2020 / 111959 A1. This document is considered the closest prior art. Further devices for collecting stool samples are known from US 2001 / 044953 A1, US 2016 / 0051445 A1, US 2016 / 0051234 A1, and US 4,368,733 B.

[0007] Against this background, the object of the present invention is to provide a device with which a donor's stool can be easily obtained for transplantation.

[0008] This problem is solved in a device of the type mentioned above by the fact that the filter element consists of a square filter sheet folded once across its diagonal, wherein the open, overlapping edges are welded to a lower corner of the collection bag, so that the filter chamber has an essentially triangular shape in a side view.

[0009] The invention is based on the idea that liquid components of the stool sample can permeate the filter element and accumulate in the filter chamber. The stool sample can then be processed in the collection bag. Liquids can be added to dissolve certain components, particularly the microorganisms contained in the stool sample. These microorganisms can then permeate the filter element and enter the filter chamber, allowing them to be extracted and administered to a patient. The device can be placed, in particular, on a toilet under the user's buttocks, so that any stool expelled can be collected in a bag.A base body with a certain degree of shape stability forms a through-opening between an upper and a lower end face, allowing the stool sample to fall through the base body into the collection bag due to gravity. The device thus enables the hygienic removal of a stool sample from a donor.

[0010] In a further embodiment, the base body can be folded or foldable from a single piece of cardboard, paperboard, or similar material. Such a design of the base body from cardboard or paperboard results in corresponding dimensional stability, so that deformation of the base body, especially when positioned under the buttocks of a dispenser, is largely prevented.

[0011] In a further embodiment, the distance between the upper and lower ends of the base body can be at least 5 cm, in particular at least 8 cm, and / or at most 28 cm, in particular at most 20 cm, preferably 12 cm. Such an extension of the base body has proven advantageous, as the corresponding device can easily be positioned in a standard toilet.

[0012] The base body can have a rectangular or rhomboid cross-section, in particular a square cross-section, such that the circumferential wall comprises four, in particular, flat side walls. This ensures sufficiently high dimensional stability. Specifically, the base body can have a rhomboid or square cross-section, with an edge length of at least 4 cm, in particular at least 6 cm, and / or at most 15 cm, in particular at most 12 cm, preferably 8 cm. A corresponding cross-section of the base body is, firstly, sufficiently large to allow a stool sample to pass through it, and secondly, such a base body fits easily into a standard toilet bowl.

[0013] In a preferred embodiment, the base body can have fastening means for attaching it to an object, in particular a toilet. This embodiment is based on the consideration that the dispenser does not have to hold the device according to the invention when excreting a stool sample, but rather that it is attached to a toilet beforehand.

[0014] Specifically, the fastening means can comprise two fastening tabs which project outwards from the upper end face of the base body on two opposite sides of the circumferential wall. Accordingly, it is provided that the fastening tabs can be attached between the rim of a toilet bowl and the toilet seat. Specifically, the fastening tabs can have a length of at least 10 cm, in particular 15 cm, and / or a length of at most 30 cm, in particular a length of at most 25 cm, preferably 18 cm. Fastening tabs of such length, projecting laterally from opposite sides of the circumferential wall, are suitable for positioning between the rim of a toilet bowl and the toilet seat in conventional toilets.

[0015] For improved fixation, adhesives, particularly in the form of adhesive strips, can be applied to the outside of the mounting tabs to attach them to an object, especially the rim of a toilet. With this design, the mounting tabs can not only be securely clamped between the upper rim of the toilet bowl and the toilet seat, but also bonded firmly to the rim of the toilet bowl using the adhesive. This significantly reduces the risk of slippage or detachment. The adhesive strips can be provided with a protective film that can be removed immediately before use.

[0016] In a specific embodiment, the fastening tabs can be pivotally arranged on the upper edge of two opposing side walls, with the fastening tabs being connected to the respective adjacent side wall, in particular via a fold line. This means that the fastening tabs can be part of a single-piece blank made of cardboard, paperboard, or the like, from which the base body is folded.

[0017] The collection bag can be attached to the base in such a way that its upper surface surrounds the lower end of the base. This ensures that a stool sample which, due to gravity, leaves the base at the bottom is reliably collected in the bag.

[0018] Two retaining tabs can be arranged on the top of the collection bag, in particular welded on, and their free ends are attached to the base body, especially to two opposing side walls of the base body, preferably with a metal clip. Such attachment via two retaining tabs allows for easy attachment of the collection bag to the base body, since, for example, the retaining tabs only need to be attached to the base body from the outside using a stapler.

[0019] To allow the collection bag to be separated from the base by tearing, the retaining tabs are preferably perforated. This allows the collection bag to be easily removed from the base after sampling, in order to further store or process the stool sample contained in the collection bag.

[0020] According to the invention, the filter element is leaf-shaped. The filter element consists of a square filter sheet folded once diagonally, with the open, overlapping edges welded to a lower corner of the collection bag, so that the filter chamber has a substantially triangular shape in a side view. In other words, a filter chamber is formed in a lower corner of the collection bag, which is separated from the receiving chamber of the collection bag by a filter sheet folded once diagonally. The filter chamber has a substantially triangular shape when the collection bag is viewed from the side.

[0021] The filter element can have a mesh size of at least 5 µm, in particular at least 25 µm, preferably at least 40 µm, and / or at most 150 µm, in particular at most 100 µm, preferably at most 70 µm, and most preferably a mesh size of 50 µm. Such mesh sizes have proven advantageous because they reliably allow microorganisms dissolved in or carried by a liquid to pass through, while reliably retaining larger pieces of the stool sample.

[0022] The filter element can consist primarily of polyethylene terephthalate (PET) and / or polyamide (PA). Such materials are chemically inert enough to prevent any alteration of microorganisms passing through the filter element.

[0023] A valve can be attached to the bottom of the collection bag, which is fluidically connected to the filter chamber to allow the filter chamber to be emptied or filled with a liquid. Preferably, the valve is designed as an injection port. Accordingly, the filter chamber, which contains in particular a liquid with the microorganisms present in the stool sample, can be easily emptied. An injection port is characterized by forming a barrier between the filter chamber and the environment, which can be pierced with a syringe. This allows the liquid to be removed from or introduced into the filter chamber in a manner known per se.

[0024] In a further embodiment, the device according to the invention can be characterized by the inclusion of an inner bag which lines the circumferential wall of the base body on its inner side. This inner bag serves to prevent the stool sample from coming into contact with the circumferential wall. Rather, the inner bag guides the stool sample, which falls towards the collection bag due to gravity. Accordingly, the inner bag is open at the top and bottom.

[0025] Preferably, the inner bag extends over the entire length of the base body between the upper and lower end faces. Furthermore, the inner bag can have a ring-shaped collar on its upper surface that covers the upper end face of the base body. Such a collar prevents components of a stool sample, particularly a thinner one, from flowing along the outside of the base body. The collar acts practically like a funnel, directing the stool sample into the interior of the base body. The inner bag can be attached to the base body in various ways. For example, the collar can be fixed to the circumferential wall using metal clips or fastening tabs. Alternatively, loops can be glued to the inner bag, especially to the collar, to secure it to the base body.

[0026] In a further embodiment, the inner bag can protrude from the bottom of the base body. This prevents the stool sample from coming into contact with the base body when exiting the inner bag from the bottom. Preferably, the inner bag is connected to the collection bag at two opposite points, particularly by welding. This ensures a stable structure for both the inner and collection bags. Furthermore, liquid can be added from the outside through the space between the inner and collection bags once the stool sample is already in the collection bag. Welding the two bags together is a simple manufacturing method. A predetermined breaking point or tear line, such as a perforation, can also be provided at the connection points to allow the collection bag to be separated from the inner bag or the base body.

[0027] In a specific embodiment, the collection bag and / or the retaining flap and / or the inner bag can consist of a polyethylene (PE) film with a thickness of at least 50 µm, in particular at least 100 µm, and / or at most 300 µm, in particular at most 250 µm. Such a thickness range is advantageous because such bags have sufficient stability on the one hand, but are also sufficiently flexible on the other.

[0028] For further details of the invention, reference is made to the dependent claims and to the exemplary embodiment described below with reference to the drawing. The drawing shows: Figure 1 shows a device for collecting a stool sample from a person according to the present invention in a perspective view in a folded state; Figure 2 shows the device made of Figure 1 in a schematic longitudinal sectional view; Figure 3 the collection bag of the device of the Figure 1 and 2 in a side view; Figure 4 the filter element of the device made of Figure 1 and Figure 2 Figure 5 shows a one-piece cutout of the basic body of the device made of Figure 1 and Figure 2 .

[0029] The Figure 1 and the Figure 2 show a device 1 for collecting a stool sample from a human being, which has a hollow base body 2 and a collection bag 3, which forms a receiving space for the stool sample.

[0030] The basic body 2 is folded from a single piece of cardboard 4. The cardboard 4 is detailed in Figure 5 depicted.

[0031] The base body 2 has a circumferential wall 5 which comprises four rectangular side walls 6a, 6b, 6c, 6d. The base body 2 is open at one upper end face and at one lower end face and has a rectangular cross-section, with an edge length of 81 mm.

[0032] Furthermore, the base body has two fastening means for attachment to a toilet, in particular between the upper rim of a toilet bowl and a toilet seat. The fastening means comprise two fastening tabs 7, which are arranged on opposite side walls 6a, 6c. In the Figure 5 It can be seen that the two fastening tabs 7 in the cutout 4 are each connected to the side walls 6a, 6c via fold line 8. The fastening tabs 7, which are 18 cm long, are also provided with an adhesive strip 9 to allow them to be attached to the edge of a toilet.

[0033] In the Figure 5It can be seen that the side walls 6a, 6b, 6c and 6d are connected to each other via fold lines 8. A mounting tab 10 is attached to the outside of side wall 6d in the blank 4 via a fold line 8, which is connected, in particular glued, to the opposite side wall 6a when folded to form the base body.

[0034] The collection bag 3 forms a receiving chamber for a stool sample and is attached to the base body 2 in such a way that a stool sample emerging from the bottom of the base body 2 can be collected in the collection bag 3. For this purpose, the upper surface of the collection bag 3 surrounds the lower end region of the base body 2 on the outside.

[0035] Two retaining tabs 11 are welded to the top of the collection bag 3. Their free ends are attached to the base body 2 by means of two opposing side walls 6b, 6d by means of a metal clamp. The retaining tabs 11 are provided with a perforation 12 to allow the collection bag 3 to be separated from the base body 2 by tearing.

[0036] The specific design of the collection bag is described in the Figure 3 The process is shown in detail. The collection bag 3 is manufactured by layering two polyethylene films, each 200 µm thick, on top of each other and welding them together along a weld line 13. The lower end of the collection bag 3 is welded in a funnel shape, meaning that the weld line 13 is angled in this area.

[0037] In the lower end region of the collection bag 3, a filter chamber 14 is formed, which is separated from the receiving chamber by a filter element 15. The filter element 15, which is located in the Figure 4 As shown in detail, it is leaf-shaped and consists of a square filter sheet folded once along its diagonal, as described in the Figure 4 as shown by the dashed line. The open, overlapping edges are welded to a lower corner of collection bag 3. Thus, as in the Figure 3A filter chamber 14 with a substantially triangular base shape is discernible. Additionally, two welding points 16 are provided on each of the two opposing films of the collection bag 3, at which the filter element 15 is welded to the films of the collection bag 3. This ensures that when a stool sample is present in the collection bag 3, the films of the collection bag separate from each other, thus allowing the filter chamber 14 to expand in volume.

[0038] A dispensing valve 17 is attached to the underside of the collection bag 3. This valve is fluidically connected to the filter chamber 14 in order to empty the filter chamber 14. Specifically, the dispensing valve 17 is designed as an injection port.

[0039] The device 1 further comprises an inner bag 18, which lines the circumferential wall 5 of the base body 2 on its inner side. This prevents a stool sample from coming into direct contact with the cardboard base body 2. The inner bag 18, open at the top and bottom, extends between the upper and lower end faces of the base body 2 and has a ring 19 at its upper end, which covers the upper end face of the base body 2.

[0040] The inner bag 18 protrudes from the base body at its bottom, extending into the collection bag 3. The inner bag 18 is welded to the collection bag 3 at two opposing connection points 20. This ensures that a stool sample can pass through the base body 2, the inner bag 18, and into the collection bag 3.

[0041] The device 1 can thus be positioned between the upper rim of a toilet bowl and the toilet seat using the fastening tabs 7 for taking a stool sample. When a stool sample is excreted, it falls through the inner bag 18, which lines the inner wall of the base body 2, into the collection bag 3. This can be separated from the base body 2 by means of the perforations on the retaining tabs 11.

[0042] The stool sample can be processed by adding liquid. This means, for example, that liquid can be introduced into the filter chamber 14 through valve 17. Microorganisms contained in the stool sample can pass through the filter element 15 and collect in the filter chamber 14. The liquid containing microorganisms collected in the filter chamber 14 can then be easily removed as needed through the dispensing valve 17. Reference symbol list

[0043] 1Vorrichtung 2Grundkörper 3Sammelbeutel 4Zuschnitt 5Umfangswand 6a, 6b, 6c. 6dSeitenwandung 7Befestigungslasche 8Falzlinie 9Klebestreifen 10Montagelasche 11Haltelasche 12Perforation 13Schweißlinie 14Filterraum 15Filterelement 16Schweißpunkt 17Entnahmeventil 18Innenbeutel 19Ringbund 20Verbindungsstelle

Claims

1. A device (1) for collecting a stool sample from a living being, in particular a human, comprising a hollow base body (2) having a peripheral wall (5) and open at its upper end face and lower end face, and a collection bag (3) open at its top, which forms a receiving chamber for a stool sample and is attached to the base body (2) in such a way that a stool sample exiting the base body (2) from the bottom can be collected in the collection bag (3), wherein a filter chamber (14) is formed in the lower end region of the collection bag (3), which is separated from the collection chamber by a sheet-like filter element (15), characterized in that the filter element (15) consists of a square filter sheet folded once along its diagonal, wherein the open, overlapping edges are heat-sealed to a lower corner of the collection bag (3), such that the filter chamber (14) has a substantially triangular basic shape when viewed from the side.

2. Device (1) according to claim 1, characterized in that the main body (2) is folded or foldable from a blank (4)-in particular a one-piece blank-made of cardboard, paperboard, or the like.

3. A device (1) according to any of the preceding claims, characterized in that the base body (2) has a rectangular or diamond-shaped cross-section, in particular a square cross-section, such that the peripheral wall (5) comprises four, in particularr flat, side walls (6a, 6b, 6c, 6d) extending around its perimeter.

4. Device (1) according to claim 3, characterized in that the base body (2) has a diamond-shaped, in particular a square, cross-section, wherein the edge length is at least 4 cm, in particular at least 6 cm, and / or at most 15 cm, in particular at most 12 cm, preferably 8 cm.

5. A device (1) according to one of the preceding claims, characterized in that the base body (2) comprises fastening means for attaching it to an object, in particular to a toilet.

6. Device (1) according to one of the preceding claims, characterized in that the collection bag (3) is attached to the base body (2) such that the top side surrounds the lower end region of the base body (2) on the outside.

7. A device (1) according to claim 6, characterized in that two retaining tabs (11) are arranged on the top side of the collection bag (3)- , in particular, welded-which are fastened with their free ends to the base body (2), in particular to two opposing side walls of the base body (2), preferably with a metal clip.

8. Device (1) according to claim 7, characterized in that the retaining tabs (11) are provided with a perforation (12) to allow the collection bag (3) to be separated from the base body (2) by tearing it off.

9. A device (1) according to any of the preceding claims, characterized in that the filter element (15) has a mesh size of at least 5 µm, in particular at least 25 µm, preferably at least 40 µm, and / or a maximum of 150 µm, in particular a maximum of 100 µm, preferably a maximum of 70 µm, and most preferably a mesh size of exactly 50 µm.

10. A device (1) according to one of the preceding claims, characterized in that the filter element (15) consists at least substantially of polyethylene terephthalate (PET) and / or polyamide (PA), and / or that a valve (17) is attached to the bottom of the collection bag (3) and is fluid-ically connected to the filter chamber (14) so that the filter chamber (14) can be emptied or filled with a liquid.

11. A device (1) according to one of the preceding claims, characterized in that an inner bag (18) is further provided, which lines the inner circumference of the peripheral wall (5) of the base body (2).

12. A device (1) according to claim 11, characterized in that the inner bag (18) extends over the entire length of the base body (2) between the upper end face and the lower end face.

13. A device (1) according to one of the preceding claims, characterized in that the collection bag (3) and / or the inner bag (18) consists of a polyethylene film having a thickness of at least 50 µm, in particular at least 100 µm, and / or at most 300 µm, in particular at most 250 µm.