Digestive fluid sampling tube and sampling device

Abstract

Disclosed in the present invention are a digestive fluid sampling tube and a sampling device. The digestive fluid sampling tube and the sampling device provided according to the embodiments of the present invention comprise a liquid collecting head, the liquid collecting head being provided with a liquid collecting opening; and a tube body, the tube body being provided with a liquid collecting channel, the liquid collecting channel communicating with the liquid collecting opening, and the outer diameter size of the tube body ranging from 1 mm to 5 mm. The digestive fluid sampling tube and the sampling device provided by the embodiments of the present invention use a sampling tube having a small outer diameter to achieve microsampling, thus lessening the pain in swallowing and dragging for patients and improving the tolerance of patients. In addition, the present invention can achieve accurate multi-site micro sampling, thereby improving diagnosis accuracy.

Description

Digestive tract fluid sampling tube and sampling device

[0001] Cross-reference information

[0002] This application claims priority to Chinese patent application No. 2023113542197 filed on October 18, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to the technical field of medical devices, and in particular to a digestive tract fluid sampling tube and a sampling device. Background Art

[0004] Digestive tract fluid is a very important test specimen for digestive system diseases. By sampling the digestive tract fluid and analyzing its components, it can assist in the diagnosis of Helicobacter pylori positivity, toxicity, drug resistance, early gastric cancer and intestinal diseases.

[0005] Existing digestive tract fluid sampling devices have problems such as complex operation, inaccurate sampling position, difficult to control sampling measurement, and great pain caused to patients.

[0006] Therefore, it is hoped that a new digestive tract fluid sampling tube and sampling device can be provided to overcome the above problems.

[0007] Summary of the Invention

[0008] In view of the above problems, the object of the present invention is to provide a digestive tract fluid sampling device, thereby reducing the patient's pain and enhancing the patient's tolerance when swallowing and pulling out.

[0009] According to one aspect of the present invention, there is provided a digestive tract fluid sampling tube, comprising:

[0010] A liquid taking head, wherein the liquid taking head is provided with a liquid taking port;

[0011] The tube body is provided with a liquid collection channel, the liquid collection channel is connected to the liquid collection port,

[0012] Wherein, the outer diameter of the tube body ranges from 1 mm to 5 mm.

[0013] Optionally, at least one of the liquid collection head and the tube body is made of at least one flexible material selected from silicone, polytetrafluoroethylene, PVC, PE and rubber.

[0014] Optionally, the inner diameter of the tube body ranges from 0.3 mm to 3 mm, and the inner diameter of the tube body is the outer diameter of the liquid collection channel.

[0015] Optionally, the liquid collection head is columnar, the transverse dimension of the liquid collection head ranges from 3 mm to 20 mm, the longitudinal dimension of the liquid collection head ranges from 2 mm to 15 mm; and the opening dimension of the liquid collection port ranges from 1 mm to 5 mm.

[0016] Optionally, at least one line length mark is provided on the tube body.

[0017] Optionally, the digestive tract fluid sampling tube further includes:

[0018] A counterweight block is arranged on the liquid collection head.

[0019] Optionally, at least a portion of the counterweight is made of magnetic material;

[0020] The liquid collection head further includes a receiving cavity for receiving the counterweight block, and the receiving cavity is located on at least one side of the liquid collection port.

[0021] Optionally, digestive tract fluid is obtained via the liquid collection head, and the digestive tract fluid includes at least one selected from Cystatin D, Pepsin A, Ela3A Elastase 3A, Gastrin, and Gastricsin.

[0022] Optionally, digestive tract fluid is obtained via the liquid collection head, and the digestive tract fluid includes at least one selected from glmM, rpoB, 16S Helicobacter pylori genes, Helicobacter pylori clarithromycin resistance genes with mutations of 23S rRNA gene A2143G, A2142C and A2142G, Helicobacter pylori quinolone antibiotic resistance genes with mutations of 261A, 261G, 259T, 271A, 271T, 272G of gyrA gene, Helicobacter pylori amoxicillin resistance gene with mutation of PBP1, Helicobacter pylori furazolidone resistance gene with mutations of PorD and oorD, Helicobacter pylori tetracycline resistance gene with mutation of 16S rRNA and Helicobacter pylori metronidazole resistance gene with mutation of rdxA.

[0023] Optionally, digestive tract fluid is obtained via the liquid collection head, and the digestive tract fluid includes a CYP2C19 gene fractal that is resistant to proton pump inhibitors.

[0024] Optionally, digestive tract fluid is obtained via the liquid collection head, and the digestive tract fluid includes at least one selected from the group consisting of CagA protein, VacA protein, UreB protein and UreA protein.

[0025] According to another aspect of the present invention, there is provided a digestive tract fluid sampling device, comprising:

[0026] The digestive tract fluid sampling tube as described in any one of the above; and

[0027] An extraction unit is communicated with the liquid collection channel to provide negative pressure to the liquid collection channel.

[0028] Optionally, the extraction unit includes:

[0029] A syringe comprising a syringe body and a piston located in the syringe body; the piston moves in the syringe body to form a liquid collection cavity, and the liquid collection cavity is connected to the liquid collection channel to provide the negative pressure to the liquid collection channel;

[0030] A stopper is connected to the syringe to limit the position of the piston in the syringe body.

[0031] Optionally, the syringe further comprises a pull rod connected to the piston and a pull rod head located at one end of the pull rod;

[0032] The limiter includes a first fixed end, a first card slot arranged opposite to the first fixed end, and a second card slot arranged opposite to the first fixed end, wherein the first card slot is connected to the second card slot and is located in the same plane;

[0033] Wherein, the syringe comprises a first size syringe and a second size syringe;

[0034] The first clamping groove fixes the pull rod head of the first size syringe, and the first fixing end fixes the syringe body of the first size syringe to fix the first size syringe;

[0035] The second clamping groove fixes the pull rod head of the second size syringe, and the first fixing end fixes the syringe body of the second size syringe to fix the second size syringe.

[0036] Optionally, the syringe further comprises a pull rod connected to the piston and a pull rod head located at one end of the pull rod;

[0037] The limiter includes a first limit surface, a second limit surface arranged opposite to the first limit surface, and a third limit surface arranged opposite to the first limit surface, wherein the second limit surface and the third limit surface are located in different planes;

[0038] Wherein, the first limiting surface fixes the syringe body, and the second limiting surface fixes the pull rod head to form a liquid collecting cavity of a first length;

[0039] The first limiting surface fixes the syringe body, and the third limiting surface fixes the pull rod head to form a liquid collecting cavity of a second length.

[0040] Optionally, the digestive tract fluid sampling device further includes:

[0041] A Luer connector, wherein the first end of the Luer connector is connected to the tube body; the second end of the Luer connector matches the syringe and is used to connect the syringe.

[0042] Wherein, the liquid collection head, the tube body and the Luer connector are integrally formed.

[0043] Optionally, the tube body is connected to a plurality of connectors, and different connectors are used to connect to different extraction units.

[0044] Optionally, when the digestive tract fluid sampling tube further includes a counterweight, and at least a portion of the counterweight is made of a magnetic material, the digestive tract fluid sampling device further includes:

[0045] A magnetic control unit is matched with the counterweight block to control the position of the counterweight block.

[0046] According to the digestive tract fluid sampling tube and sampling device of the embodiment of the present invention, a sampling tube with a small outer diameter is used to achieve micro-sampling, which can reduce the pain of the patient when swallowing and pulling out, and enhance the patient's tolerance.

[0047] Furthermore, the liquid sampling channel has a thin diameter, which can also avoid the absorption of solids such as residues, and can perform precise multi-point microsampling to improve the accuracy of diagnosis.

[0048] Furthermore, the outer diameter of the liquid collection channel ranges from 0.3 to 3 mm, which reduces the pain of the patient while ensuring a certain liquid collection efficiency.

[0049] Furthermore, in order to solve the problem of difficulty in extracting digestive tract fluid from a small outer diameter digestive tract fluid sampling tube, an extraction unit is further provided to provide negative pressure to the liquid sampling channel to achieve sampling.

[0050] Furthermore, the extraction unit includes a syringe and a limiter. The limiter is used to fix the extraction position of the syringe to maintain the negative pressure in the syringe. The setting of the limiter reduces the difficulty of manual operation during the sampling process; the setting of the limiter can also achieve quantitative sampling.

[0051] Furthermore, the limiter is provided with different slots to accommodate syringes of different sizes, and has a wide range of applications.

[0052] Furthermore, different limiting surfaces are provided on the limiter to adapt to liquid collecting cavities of different lengths; by using liquid collecting cavities of different lengths in sequence, a stable negative pressure can be maintained in the syringe for a long time during multi-point sampling.

[0053] Furthermore, the tube body is connected to different extraction units through multiple connectors, thereby enabling multi-point sampling.

[0054] Furthermore, a counterweight is provided on the liquid taking head to facilitate the movement of the liquid taking head.

[0055] Furthermore, the counterweight block includes a magnetic material, which can accurately control the position of the liquid sampling head in the human body through magnetic control, thereby achieving accurate sampling.

[0056] Furthermore, with the cooperation of magnetic control and limiters, multi-point sampling at different positions can be achieved.

[0057] Furthermore, a line length mark is provided on the tube body, which can accurately control the amount of liquid taken. BRIEF DESCRIPTION OF THE DRAWINGS

[0058] The above and other objects, features and advantages of the present invention will become more apparent through the following description of the embodiments of the present invention with reference to the accompanying drawings, in which:

[0059] FIG1 shows a schematic structural diagram of a digestive tract fluid sampling tube according to a first embodiment of the present invention.

[0060] FIG2 shows a schematic structural diagram of a liquid collection head according to a second embodiment of the present invention.

[0061] FIG3 shows a schematic cross-sectional view of a tube body according to a third embodiment of the present invention.

[0062] FIG4 shows a schematic structural diagram of a digestive tract fluid sampling tube according to a fourth embodiment of the present invention.

[0063] FIG5 shows a schematic cross-sectional view of a digestive tract fluid sampling tube according to a fifth embodiment of the present invention.

[0064] FIG6 shows a schematic cross-sectional view of a digestive tract fluid sampling tube according to a sixth embodiment of the present invention.

[0065] FIG7 shows a schematic structural diagram of a digestive tract fluid sampling device according to a seventh embodiment of the present invention.

[0066] FIG8 shows a schematic structural diagram of a digestive tract fluid sampling device according to an eighth embodiment of the present invention.

[0067] FIG9 shows a schematic structural diagram of an extraction unit according to a ninth embodiment of the present invention.

[0068] FIG10 shows a schematic structural diagram of an extraction unit according to a tenth embodiment of the present invention.

[0069] FIG11 shows a schematic structural diagram of a digestive tract fluid sampling device according to an eleventh embodiment of the present invention.

[0070] FIG12 shows a schematic diagram of an application scenario of a digestive tract fluid sampling device according to an embodiment of the present invention.

[0071] FIG13 shows a schematic diagram of an application scenario of a digestive tract fluid sampling device according to an embodiment of the present invention.

[0072] FIG14 shows a schematic diagram of an application scenario of a digestive tract fluid sampling device according to an embodiment of the present invention.

[0073] FIG15 shows a schematic diagram of an application scenario of a digestive tract fluid sampling device according to an embodiment of the present invention.

[0074] FIG16 shows a schematic diagram of an application scenario of a digestive tract fluid sampling device according to an embodiment of the present invention.

[0075] FIG17 shows a schematic diagram of an application scenario of a digestive tract fluid sampling device according to an embodiment of the present invention.

[0076] FIG18 is a schematic diagram showing the control principle of the digestive tract fluid sampling device according to an embodiment of the present invention. DETAILED DESCRIPTION

[0077] Various embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. In each of the accompanying drawings, identical elements are represented by identical or similar reference numerals. For clarity, the various parts in the accompanying drawings are not drawn to scale. In addition, certain well-known parts may not be shown in the drawings.

[0078] Specific embodiments of the present invention are described in further detail below with reference to the accompanying drawings and examples. Numerous specific details of the present invention, such as component structures, materials, dimensions, processing techniques, and technologies, are described below to facilitate a clearer understanding of the present invention. However, as those skilled in the art will appreciate, the present invention may be practiced without these specific details.

[0079] It should be understood that when describing the structure of a component, when a layer or a region is referred to as being "on" or "over" another layer or region, it may mean that it is directly on the other layer or region, or that other layers or regions are included between it and the other layer or region. Furthermore, if the component is turned over, the layer or region will be "below" or "beneath" the other layer or region.

[0080] Figure 1 shows a schematic structural diagram of a digestive tract fluid sampling tube according to embodiment 1 of the present invention. As shown in Figure 1 , the digestive tract fluid sampling tube according to embodiment 1 of the present invention comprises a liquid sampling head 100 and a tube body 200 .

[0081] Specifically, a liquid collection port 110 is provided on the liquid collection head 100. A liquid collection channel 210 is provided on the tube body 200, and the liquid collection channel 210 is connected to the liquid collection port 110. The outer diameter of the tube body 200 is in the range of 1 mm to 5 mm (here it means that the outer diameter of the tube body 200 can be any value between 1-5 mm, and can be 1 mm or 5 mm). When sampling, the digestive tract fluid passes through the liquid collection port 110 and the liquid collection channel 210 in sequence. Optionally, the opening size of the liquid collection port 110 is in the range of 1 mm to 5 mm; the opening size of the liquid collection port 110 is, for example, the same as the size of the liquid collection channel 210.

[0082] Optionally, the liquid collection head 100 and / or the tube body 200 are made of a flexible material. The flexible material may be at least one of silicone, polytetrafluoroethylene, PVC (polyvinyl chloride), PE (polyethylene), and rubber. Optionally, the inner diameter and / or outer diameter of the tube body 200 may be constant or variable.

[0083] FIG2 is a schematic diagram of the structure of a liquid dispensing head according to a second embodiment of the present invention. As shown in FIG2 , the liquid dispensing head 100 is cylindrical, with a lateral dimension ranging from 3 mm to 20 mm and a longitudinal dimension ranging from 2 mm to 15 mm. Of course, the liquid dispensing head 100 may also have other shapes.

[0084] FIG3 shows a schematic cross-sectional view of a tube body according to a third embodiment of the present invention. As shown in FIG3 , the outer diameter D of the tube body 200 ranges from 1 mm to 5 mm, and the inner diameter d of the tube body 200 ranges from 0.3 mm to 3 mm. The inner diameter d of the tube body 200 is the outer diameter of the liquid extraction channel. In some specific embodiments, the outer diameter of the tube body 200 is 1.5 mm and the inner diameter is 0.5-1 mm; the outer diameter of the tube body 200 is 1.2 mm and the inner diameter is 0.5-0.8 mm; and the outer diameter of the tube body 200 is 1 mm and the inner diameter is 0.4-0.6 mm.

[0085] FIG4 shows a schematic structural diagram of a gastrointestinal fluid sampling tube according to a fourth embodiment of the present invention. As shown in FIG4 , at least one line length mark 220 is provided on the tube body 200. When there are multiple line length marks 220, the shapes of different line length marks 220 are different. The line length mark 220 is used to mark the different length positions of the tube body 200. Based on the line length mark 220 on the tube body 200, the position of the tube body 200 (liquid sampling head 100) can be preliminarily judged, and the liquid sampling situation (liquid sampling amount, etc.) can also be preliminarily judged based on the line length mark 220.

[0086] 5 shows a cross-sectional view of a digestive tract fluid sampling tube according to a fifth embodiment of the present invention. As shown in FIG5 , the digestive tract fluid sampling device according to the fifth embodiment of the present invention further includes a Luer connector 300 and a counterweight 120 .

[0087] Specifically, the first end of the Luer connector 300 is connected to the tubing 200, while the second end of the Luer connector 300 is compatible with a syringe (the second end of the Luer connector 300) and is used to connect to the syringe. The liquid collection head 100, tubing 200, and Luer connector 300 are integrally formed. The reduced diameter tubing and the standard Luer connector reduce sampling losses.

[0088] The counterweight 120 is provided on the liquid collection head 100. Optionally, at least a portion of the counterweight 120 is made of magnetic material. The liquid collection head 100 also includes a housing for accommodating the counterweight 120, and the housing is located on at least one side of the liquid collection port. Optionally, a magnetic control unit is provided on the outside, and the magnetic control unit matches the counterweight 120 to control the position of the counterweight 120. In a specific embodiment, the liquid collection head 100 made of silicone material is inlaid with an annular magnet / annular ferromagnetic metal / other metal (counterweight 120), and the counterweight 120 is used for counterweighting to assist the liquid collection head 100 in sinking into the digestive fluid.

[0089] Figure 6 shows a cross-sectional schematic diagram of a digestive tract fluid sampling tube according to a sixth embodiment of the present invention. As shown in Figure 6 , the digestive tract fluid sampling device according to the sixth embodiment of the present invention includes a liquid sampling head 100, a tube body 200, and a Luer connector 300. The liquid sampling head 100 is provided with a counterweight 120.

[0090] Specifically, the plastic liquid collection head 100 includes a plastic front shell, a plastic rear shell, and an annular magnet (counterweight 120). The annular magnet serves as a counterweight to aid the liquid collection head in sinking into the digestive fluid. The annular magnet can be replaced with an annular ferromagnetic metal or other metal. The liquid collection head 100 is connected to the tubular body 200, for example, by bonding, and the tubular body 200 is connected to the Luer connector 300, for example, by bonding.

[0091] In an optional embodiment of the present invention, digestive tract fluid is obtained via the liquid collection head 100. The digestive tract fluid contains at least one gastric cancer tumor marker selected from Cystatin D, Pepsin A, Ela3A, Gastrin, Gastricsin, and the like. Optionally, the H. pylori in the digestive tract fluid contains at least one of the following: H. pylori genes selected from glmM, rpoB, and 16S; H. pylori clarithromycin resistance genes with mutations in the 23S rRNA gene A2143G, A2142C, and A2142G; H. pylori quinolone antibiotic (levofloxacin hydrochloride) resistance genes with mutations in the gyrA gene 261A, 261G, 259T, 271A, 271T, and 272G; H. pylori amoxicillin resistance genes with mutations in PBP1; H. pylori furazolidone resistance genes with mutations in PorD and oorD; H. pylori tetracycline resistance genes with mutations in the 16S rRNA; and H. pylori metronidazole resistance genes with mutations in rdxA. Optionally, the digestive tract fluid contains a fractal of the CYP2C19 gene, which is resistant to proton pump inhibitors. Optionally, the digestive tract fluid contains CagA and / or VacA proteins. Optionally, the digestive tract fluid contains UreB and / or UreA proteins. Optionally, the digestive tract fluid sampling tube is connected to a detection device to provide the digestive tract fluid to the detection device. The detection device detects whether the digestive tract fluid contains the above-mentioned proteins, genes (fragments) and / or the content of the above-mentioned proteins, genes (fragments) in the digestive tract fluid.

[0092] According to another aspect of the present invention, a digestive tract fluid sampling device is provided. The digestive tract fluid sampling device includes the digestive tract fluid sampling tube described above and an extraction unit. The extraction unit is connected to a liquid collection channel to provide negative pressure to the liquid collection channel. During liquid collection, the extraction unit applies negative pressure to a liquid collection head through the liquid collection channel, thereby aspirating digestive tract fluid through the liquid collection head.

[0093] FIG7 is a schematic diagram showing the structure of a digestive tract fluid sampling device according to a seventh embodiment of the present invention. As shown in FIG7 , the digestive tract fluid sampling device according to the seventh embodiment of the present invention includes a liquid sampling head 100, a tube body 200, and an extraction unit. The extraction unit includes a syringe 400 and a stopper 500.

[0094] Specifically, the syringe 400 includes a syringe body and a piston located in the syringe body. The piston moves in the syringe body to form a liquid collection cavity, which is connected to the liquid collection channel to provide negative pressure to the liquid collection channel.

[0095] The limiter 500 is connected to the syringe 400 (for clarity, the two are shown separately in Figure 7) to limit the position of the piston in the syringe body. When taking liquid, the liquid collection head 100 is immersed in the digestive tract fluid to be sampled. The syringe 400 piston is pulled out and maintained to form a negative pressure liquid collection cavity in the syringe body. The syringe 400 is fixed on the limiter 500 to prevent the piston from retracting due to negative pressure. Tubes with smaller diameters may need to maintain a certain sampling time to complete sampling. The setting of the limiter 500 avoids manual operation all the time and reduces the difficulty of operation.

[0096] FIG8 is a schematic diagram illustrating the structure of a digestive tract fluid sampling device according to an eighth embodiment of the present invention. As shown in FIG8 , the digestive tract fluid sampling device according to the eighth embodiment of the present invention includes a liquid sampling head 100, a tube body 200, and an extraction unit. The extraction unit includes a syringe 400 and a liquid extraction microinjection pump 510.

[0097] When sampling liquid, the liquid sampling head 100 is immersed in the digestive tract fluid to be sampled. The syringe 400 is installed on the liquid sampling microinjection pump 510, which pushes back to form a negative pressure liquid collection cavity in the syringe body.

[0098] Fig. 9 shows a schematic structural diagram of an extraction unit according to a ninth embodiment of the present invention. As shown in Fig. 9 , the extraction unit according to the ninth embodiment of the present invention includes a syringe 400 and a stopper 500 .

[0099] Specifically, the syringe 400 also includes a pull rod connected to the piston and a pull rod head located at one end of the pull rod (the piston, pull rod and pull rod head of the syringe 400 are all well-known parts and are not marked in the figure).

[0100] The stopper 500 includes a first fixed end 501, a first slot 502 disposed opposite to the first fixed end 501, and a second slot 503 disposed opposite to the first fixed end 501. The first slot 502 and the second slot 503 are connected and located in the same plane.

[0101] Syringe 400 includes a first-size syringe (e.g., a 20ml syringe with a smaller diameter) and a second-size syringe (e.g., a 50ml syringe with a larger diameter). A first slot 502 secures the pull rod of the first-size syringe, while a first fixed end 501 secures the syringe body of the first-size syringe. A second slot 503 secures the pull rod of the second-size syringe, while a first fixed end 501 secures the syringe body of the second-size syringe. Different slots accommodate syringes of different sizes when drawing liquid.

[0102] Fig. 10 shows a schematic structural diagram of an extraction unit according to the tenth embodiment of the present invention. As shown in Fig. 10 , the extraction unit according to the tenth embodiment of the present invention includes a syringe 400 and a stopper 500 .

[0103] Specifically, the syringe 400 further includes a pull rod connected to the piston and a pull rod head located at one end of the pull rod.

[0104] The stopper 500 includes a first limiting surface 504, a second limiting surface 505 disposed opposite the first limiting surface 504, and a third limiting surface 506 disposed opposite the first limiting surface 504. The second limiting surface 505 and the third limiting surface 506 are located on different planes. Optionally, the stopper 500 further includes a fourth limiting surface 507 disposed opposite the first limiting surface 504 and different from the second limiting surface 505 and the third limiting surface 506.

[0105] The first limiting surface 504 secures the syringe body, and the second limiting surface 505 secures the rod head to form a first length liquid collection cavity (piston length L1). The first limiting surface 504 secures the syringe body, and the third limiting surface 506 secures the rod head to form a second length liquid collection cavity (piston length L2). The first limiting surface 504 secures the syringe body, and the fourth limiting surface 507 secures the rod head to form a third length liquid collection cavity (piston length L3).

[0106] During liquid collection, when the piston reaches length L1, the negative pressure within the syringe body disappears. The piston is then extended to L2 and locked in the L2 limit position (third limit surface 506). When the negative pressure disappears at position L2, the piston is extended to L3 and locked in the L3 limit position (fourth limit surface 507). This method of liquid collection enables the negative pressure within the syringe body (liquid collection cavity) to be maintained for a long time during multi-point liquid collection.

[0107] FIG11 is a schematic diagram of the structure of a digestive tract fluid sampling device according to Example 11 of the present invention. As shown in FIG11 , a plurality of connectors 301 are connected to the tube body 200, and different connectors 301 are used to connect to different extraction units (syringes). A liquid collection head 100 is connected to multiple connectors (Luer connectors), which in turn are connected to multiple syringes. When the device reaches a certain position, the corresponding syringe is activated, the piston is pulled open, and the piston is locked on the limiter, thereby achieving a sampling scheme that combines multiple sampling points.

[0108] Figures 12 to 17 show schematic diagrams of application scenarios of the digestive tract fluid sampling device according to an embodiment of the present invention. In conjunction with Figures 12 to 17, taking the sampling of gastric fluid as an example, the application scenarios and usage methods of the digestive tract fluid sampling device according to an embodiment of the present invention are introduced in detail. Of course, the digestive tract fluid sampling device according to an embodiment of the present invention is not limited to the sampling of gastric fluid, but can also be used for sampling digestive tract fluid in locations such as the esophagus, cardia, greater curvature, lesser curvature and duodenum. The digestive tract fluid obtained by sampling can be widely used for medical examinations, analysis, etc.

[0109] Helicobacter pylori is highly pathogenic and has a high infection rate, affecting more than half of my country's population. Meanwhile, treatment options for Helicobacter pylori are generally plagued by high rates of drug resistance and low eradication rates.

[0110] In order to improve the treatment effect, it is very important to conduct research on the drug resistance of Helicobacter pylori. The current gold standard for Helicobacter pylori drug resistance detection requires the use of a gastroscope inserted into the stomach to take multiple mucosal samples, and then isolate Helicobacter pylori for culture. This sampling process is invasive and requires the patient to have a strong tolerance or be anesthetized, and the process is complicated. Using the digestive tract fluid sampling device according to an embodiment of the present invention, a soft, thin-diameter tube can be swallowed, and gastric fluid can be collected from various parts of the stomach by gravity or magnetism, thereby obtaining Helicobacter pylori from the gastric fluid.

[0111] Figure 12 shows the use of the syringe in either a standing or sitting position. The liquid collection head 100, under the weight of the counterweight, naturally reaches the gastric corpus, and gastric fluid is aspirated through the liquid collection head 100 and tube body 200. Depending on the desired amount of fluid to be collected, the syringe piston is extended to a value greater than or equal to the desired amount. When using a peristaltic pump, the piston can be continuously extended to provide a continuous negative pressure.

[0112] FIG13 shows that the patient is in the left lateral decubitus position, and the liquid collecting head 100 reaches the stomach fundus under the action of gravity of the counterweight, and the stomach liquid can be sucked through the liquid collecting head 100 and the tube body 200.

[0113] Figure 14 shows that in the right side lying position, the liquid collecting head 100 reaches the gastric antrum under the action of the gravity of the counterweight block, and the gastric fluid in the gastric antrum can be collected through the liquid collecting head 100 and the tube body 200. After the length of the tube body 200 is recovered, the liquid collecting head 100 can collect gastric fluid from the lesser curvature of the stomach.

[0114] FIG15 shows that in the right side lying position, the liquid collection head 100 enters the duodenum under the action of the gravity of the counterweight block and gastric peristalsis, and duodenal fluid is obtained through the liquid collection head 100 and the tube body 200.

[0115] Figure 16 shows the process of liquid collection in the supine position. The magnetic ball (external magnetic field magnet) 600 drags the liquid collection head 100 to position at different positions in the stomach. After positioning is completed, the liquid collection head 100 and the tube body 200 can be used to collect gastric fluid.

[0116] Figure 17 shows the process of liquid collection in the prone position. The magnetic ball 600 drags the liquid collection head 100 to position at different positions in the stomach. After positioning is completed, the liquid collection head 100 and the tube body 200 can be used to collect gastric fluid.

[0117] According to the digestive tract fluid sampling device of an embodiment of the present invention, body fluids (digestive tract fluids) at different positions of the stomach, such as the esophagus, gastric fundus, gastric body, gastric angle, gastric antrum and duodenum, are obtained under different human body positions through the gravity (counterweight block) at the end of the liquid sampling head 100 and the length of the flexible tube (tube body 200).

[0118] Furthermore, as shown in FIG18 , by controlling an (external) magnet, combined with the gravity of the liquid collection head and the length of the flexible tube, body fluids at different positions of the stomach, such as the esophagus, gastric fundus, gastric body, gastric angle, gastric antrum and duodenum, are obtained under different human body positions.

[0119] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of additional identical elements in the process, method, article, or apparatus comprising the element.

[0120] While embodiments of the present invention have been described above, these embodiments do not exhaustively describe all details and do not limit the invention to the specific embodiments described. Obviously, many modifications and variations are possible based on the above description. These embodiments are selected and described in detail in this specification in order to better explain the principles and practical applications of the present invention, thereby enabling those skilled in the art to better utilize the present invention and its modifications. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A digestive tract fluid sampling tube, comprising: A liquid collecting head, wherein the liquid collecting head is provided with a liquid collecting port; A tube body, wherein a liquid collection channel is provided on the tube body, and the liquid collection channel is connected to the liquid collection port, Wherein, the outer diameter of the tube body ranges from 1 mm to 5 mm.

2. The digestive tract fluid sampling tube according to claim 1, wherein: At least one of the liquid collection head and the tube body is made of at least one flexible material selected from the group consisting of silicone, polytetrafluoroethylene, PVC, PE and rubber.

3. The digestive tract fluid sampling tube according to claim 1, wherein: The inner diameter of the tube body ranges from 0.3 mm to 3 mm, and the inner diameter of the tube body is the outer diameter of the liquid collection channel.

4. The digestive tract fluid sampling tube according to claim 1, wherein: The liquid collection head is columnar, the transverse dimension of the liquid collection head is in the range of 3 mm to 20 mm, the longitudinal dimension of the liquid collection head is in the range of 2 mm to 15 mm; the opening dimension of the liquid collection port is in the range of 1 mm to 5 mm.

5. The digestive tract fluid sampling tube according to claim 1, wherein: At least one line length mark is arranged on the tube body.

6. The digestive tract fluid sampling tube according to claim 1, wherein: The digestive tract fluid sampling tube also includes: A counterweight block is arranged on the liquid collection head.

7. The digestive tract fluid sampling tube according to claim 6, wherein: At least a portion of the counterweight is made of magnetic material; The liquid collection head further comprises a receiving cavity for receiving the counterweight block, and the receiving cavity is located at least on one side of the liquid collection port.

8. The digestive tract fluid sampling tube according to claim 1, wherein: The digestive tract fluid is obtained through the liquid collection head, and the digestive tract fluid includes at least one selected from Cystatin D, Pepsin A, Ela3A Elastase 3A, Gastrin and Gastricsin gastric juice lipase.

9. The digestive tract fluid sampling tube according to claim 1, wherein: The digestive tract fluid is obtained via the liquid collection head, and the digestive tract fluid includes at least one selected from the group consisting of glmM, rpoB, 16S Helicobacter pylori genes, 23S rRNA gene A2143G, A2142C and A2142G mutations of Helicobacter pylori clarithromycin resistance genes, gyrA gene 261A, 261G, 259T, 271A, 271T, 272G mutations of Helicobacter pylori quinolone antibiotic resistance genes, PBP1 mutations of Helicobacter pylori amoxicillin resistance genes, PorD and oorD mutations of Helicobacter pylori furazolidone resistance genes, 16S rRNA mutations of Helicobacter pylori tetracycline resistance genes and rdxA mutations of Helicobacter pylori metronidazole resistance genes.

10. The digestive tract fluid sampling tube according to claim 1, wherein: The digestive tract fluid is obtained through the liquid collection head, and the digestive tract fluid includes the CYP2C19 gene fractal that is resistant to proton pump inhibitors.

11. The digestive tract fluid sampling tube according to claim 1, wherein: The digestive tract fluid is obtained through the liquid collection head, and the digestive tract fluid includes at least one selected from the group consisting of CagA protein, VacA protein, UreB protein and UreA protein.

12. A digestive tract fluid sampling device, comprising: The digestive tract fluid sampling tube according to any one of claims 1 to 11; as well as An extraction unit is communicated with the liquid collection channel to provide negative pressure to the liquid collection channel.

13. The digestive tract fluid sampling device according to claim 12, wherein: The extraction unit comprises: A syringe, comprising a syringe body and a piston located in the syringe body; the piston moves in the syringe body to form a liquid collecting cavity, and the liquid collecting cavity is connected to the liquid collection channel to provide the negative pressure to the liquid collection channel; A stopper is connected to the syringe to limit the position of the piston in the syringe body.

14. The digestive tract fluid sampling device according to claim 13, wherein: The syringe also includes a pull rod connected to the piston and a pull rod head located at one end of the pull rod; The stopper comprises a first fixed end, a first slot arranged opposite to the first fixed end, and a second slot arranged opposite to the first fixed end, wherein the first slot is connected to the second slot and located in the same plane; Wherein, the syringe comprises a first size syringe and a second size syringe; The first clamping groove fixes the pull rod head of the first size syringe, and the first fixing end fixes the syringe body of the first size syringe to fix the first size syringe; The second clamping groove fixes the pull rod head of the second size syringe, and the first fixing end fixes the syringe body of the second size syringe to fix the second size syringe.

15. The digestive tract fluid sampling device according to claim 13, wherein: The syringe also includes a pull rod connected to the piston and a pull rod head located at one end of the pull rod; The limiter comprises a first limit surface, a second limit surface arranged opposite to the first limit surface, and a third limit surface arranged opposite to the first limit surface, wherein the second limit surface and the third limit surface are located in different planes; Wherein, the first limiting surface fixes the syringe body, and the second limiting surface fixes the pull rod head to form a liquid collecting cavity of a first length; The first limiting surface fixes the syringe body, and the third limiting surface fixes the pull rod head to form a liquid collecting cavity of a second length.

16. The digestive tract fluid sampling device according to claim 12, wherein: The digestive tract fluid sampling device also includes: A Luer connector, wherein the first end of the Luer connector is connected to the tube body; the second end of the Luer connector matches the syringe and is used to connect the syringe. Wherein, the liquid collection head, the tube body and the Luer connector are integrally formed.

17. The digestive tract fluid sampling device according to claim 12, wherein: The tube body is connected with a plurality of connectors, and different connectors are used to connect different extraction units.

18. The digestive tract fluid sampling device according to claim 12, wherein: When the digestive tract fluid sampling tube further includes a counterweight block, and at least a portion of the counterweight block is made of a magnetic material, the digestive tract fluid sampling device further includes: A magnetic control unit is matched with the counterweight block to control the position of the counterweight block.

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