Helicobacter pylori bedside detection device

Abstract

The utility model discloses a bedside detection device for helicobacter pylori, which belongs to the related technical field of detection of NH3 in exhaled air of a human body, and is characterized in that the device is composed of an air blowing pipe, an air filter, a detection pipe and the like, the detection pipe is internally provided with wet detection test paper sensitive to pH value, and the detection test paper is arranged in the air blowing pipe. Helicobacter pylori has the capability of synthesizing and secreting urease to decompose urea to generate CO2 and NH3, and CO2 and NH3 can be discharged out of a body along with exhaled air, so that when a subject infected with helicobacter pylori orally takes urea and then blows air into the detection tube through the air blowing tube, NH3 in the exhaled air of the subject can be adsorbed and dissolved on the wet detection test paper in the detection tube, and the detection test paper can be used for detecting whether the subject is infected with the helicobacter pylori or not. The pH value of the detection test paper is increased, so that the color of the detection test paper is changed, whether a subject is accompanied with helicobacter pylori infection or not can be judged, the device is simple in structure, low in cost and convenient to use, special equipment is not needed, and the subject can complete bedside detection of helicobacter pylori in a self-service mode.

Description

Technical Field

[0001] This invention relates to a device for rapid detection of Helicobacter pylori (HP). Utilizing the characteristic of HP to specifically decompose urea into carbon dioxide (CO2) and ammonia (NH3), this invention achieves rapid detection of HP by detecting NH3 in exhaled breath. It belongs to the field of medical technology, specifically relating to a bedside detection device for Helicobacter pylori. Background Technology

[0002] *Helicobacter pylori* (H. pylori) is a Gram-negative microaerophilic bacterium that can colonize and grow long-term on the mucosa of the pylorus and antrum of the human stomach. It has been confirmed that *H. pylori* can synthesize and secrete urease to decompose urea, producing CO2 and NH3 to neutralize gastric acid, thus creating a near-neutral microenvironment around *H. pylori* to protect its adhesion and long-term survival in the stomach. Simultaneously, the CO2 and NH3 produced by *H. pylori* decomposition of urea enter the bloodstream and are exhaled through the alveoli. Furthermore, studies have shown that the NH3 content in the exhaled breath of normal individuals is between 0 and 2.0 ppm, while the NH3 content in the exhaled breath of *H. pylori*-infected individuals ranges from 1.7 to 10 ppm, which is 2 to 5 times higher than that of normal individuals. This is the biochemical basis for detecting *H. pylori* infection through breath tests.

[0003] Currently, the global infection rate of *Helicobacter pylori* (HP) is approximately 50%, and my country is a high-infection area, with about 40% to 60% of the population (approximately 600 to 800 million people) carrying HP. It is now clear that HP infection is a significant cause of gastritis, peptic ulcers, gastric cancer, and gastric mucosa-associated lymphoid tissue extranodal marginal zone B-cell lymphoma. The lifetime risk of developing gastric cancer in HP-infected individuals is 1% to 5%, and approximately 90% of gastric cancer cases are related to HP infection. Furthermore, eradicating HP can effectively reduce the risk and progression of HP-related gastric diseases. Therefore, screening and early diagnosis of HP infection are crucial measures for the effective prevention and control of HP-related diseases.

[0004] To date, invasive endoscopic mucosal biopsy and non-invasive methods have been developed. 13 C-breath test and 14 The C-breath test has been proven to be the most reliable and commonly used method for detecting H. pylori infection.

[0005] Gastric mucosal biopsy is considered the gold standard for diagnosing Helicobacter pylori infection. However, because it is an invasive procedure, patients experience some discomfort, and the process is complex, time-consuming, and labor-intensive, requiring a specialist physician to perform it. Therefore, it is not suitable for large-scale screening and early diagnosis of Helicobacter pylori infection.

[0006] and 13C-breath test and 14 The C breath test is a non-invasive method for detecting Helicobacter pylori (HP) based on the property that HP synthesizes urease, which breaks down urea to produce CO2 and NH3. 13 C-breath test and 14 The C-breath test method is as follows: when the subject swallows... 13 C or 14 After C-labeled urea is applied, if the subject has Helicobacter pylori infection, the Helicobacter pylori in their stomach will be broken down by synthesizing and secreting urease. 13 C or 14 C-labeled urea, thus generating 13 C or 14 Carbon-labeled CO2 and unlabeled NH3 are exhaled and expelled from the body. At this time, a special isotope detection device is used to detect the CO2 in the subject's exhaled breath. 13 C or 14 The level of C can be used to diagnose HP infection.

[0007] Although, 13 C-breath test and 14 The C-breath test, with its simple operation, rapid detection, high sensitivity, and non-invasiveness, has become the most widely used method for detecting Helicobacter pylori (HP). However, 13 C-breath test and 14 All C-breath tests require specialized isotope detection equipment to complete. Meanwhile, 14 C also has some radioactivity, although... 14 C-labeled urea 14 The C dose is extremely low (approximately 27.8 kBq), with a radiation dose of about 1.59 μSv, a biological half-life of about 6 hours, and very weak radioactivity. However, for safety reasons, 14 The C-breath test is not suitable for detecting H. pylori infection in pregnant women, breastfeeding women, and children. Therefore, 13 C-breath test and 14 The C-breath test cannot achieve true point-of-care testing of HP.

[0008] Recently, several scholars and institutions have established new methods for detecting *Helicobacter pylori* (HP). Among these, techniques that diagnose HP infection by detecting NH3 levels in exhaled breath require specific sensors, laser chromatography, mass spectrometry, and specialized equipment, as well as sampling bags or other nitrogen-fixing devices, to accurately detect NH3 in exhaled breath. Therefore, compared to... 13 C-breath test and 14 The above strategies and methods did not demonstrate significant technical and cost advantages in the C-breath test.

[0009] Meanwhile, some researchers have developed a method to diagnose *Helicobacter pylori* (HP) infection by detecting urease activity. This method uses urea-containing test strips to detect the urease content in swabs from teeth, gums, and the mouth to determine the presence of HP infection. However, due to the diverse range of microorganisms in the oral cavity, this method can only prove the presence of bacteria that synthesize urease in the mouth, and cannot directly prove the presence of HP infection in the stomach. Therefore, this method has low specificity and cannot meet clinical needs.

[0010] In addition, while techniques such as fecal antigen testing, blood antibody testing, polymerase chain reaction (PCR) assays, and rapid urease tests in saliva, gastric mucus, or mucosal biopsy samples can also be used to detect *Helicobacter pylori* (HP) infection, they often fail to meet clinical needs due to inconvenience, low specificity, poor timeliness, or invasiveness.

[0011] Therefore, in order to overcome the above problems, there is an urgent need to develop a new non-invasive bedside HP detection method that is simple to operate, easy to use, widely applicable, low in cost, reliable in results, requires no special equipment, and is easy to promote.

[0012] This utility model aims to overcome or alleviate some of the aforementioned problems. Summary of the Invention

[0013] To overcome the shortcomings of existing technologies, the purpose of this utility model is to provide a Helicobacter pylori (H. pylori) point-of-care testing device to solve the problem that existing technologies are unable to achieve H. pylori point-of-care testing.

[0014] To achieve this objective, the present invention employs the following technical solution:

[0015] This utility model discloses a bedside detection device for Helicobacter pylori, including an air blowing tube, an air filter, and a detection tube.

[0016] The air blowing tube is a hollow tubular structure. One end of the air blowing tube is an air blowing port, which is funnel-shaped or hollow tubular in shape to match the shape of a person's mouth. The other end of the air blowing tube is a detection port, which can be connected to the detection tube by direct sleeve or threaded interface.

[0017] The air filter is a hollow cylindrical structure, the outer diameter of which matches the inner diameter of the air outlet side cavity of the air blowing pipe, and can be connected to the air outlet side cavity of the air blowing pipe by direct sleeve or threaded interface.

[0018] The air filter is equipped with an air filter element, which can be made of one of the following: glass fiber filter cotton, synthetic fiber filter cotton, non-woven fabric filter cotton, or filter paper. Non-woven fabric filter cotton or filter paper is preferred.

[0019] The detection tube is an independent sealed structure with a hollow cylindrical bottom and a hollow flat-top conical shape at the top. The inner diameter of the bottom opening side of the detection tube matches the outer diameter of the detection port side of the air blowing tube, and it can be connected to the detection port of the air blowing tube by direct sleeve or threaded interface.

[0020] The top of the detection tube is provided with an exhaust port with an aperture of 0.5cm to 1.0cm, and a double-layer mesh exhaust net is provided inside the exhaust port.

[0021] The double-layer exhaust mesh contains a moist pH-sensitive test paper, and the bottom opening and top exhaust port of the test tube are sealed with sealing film.

[0022] The test paper inside the detection tube can be moistened phenol red test paper or precision pH test paper that has been soaked in pure water with a pH value of 7.0;

[0023] The sealing film can be made of one or more base materials such as polypropylene and polyethylene.

[0024] Preferably, the air inlet of the air tube has a funnel-shaped configuration that matches the shape of a person's mouth;

[0025] Preferably, the test paper in the test tube is phenol red test paper with a pH detection range of 6.8-8.0, which has been soaked in pure water with a pH value of 7.0.

[0026] The detection principle of this invention is as follows: *Helicobacter pylori* (HP) has the ability to synthesize and secrete urease to decompose urea, generating CO2 and NH3 to neutralize stomach acid, thus protecting HP from adhesion and long-term survival in the stomach. Furthermore, the CO2 and NH3 generated from the decomposition of urea by HP enter the bloodstream and are exhaled through the alveoli. Therefore, the detection and diagnosis of HP infection can be achieved by detecting the NH3 content in exhaled breath.

[0027] As is well known, NH3 is a water-soluble alkaline gas that can rapidly raise the pH value of water. Therefore, this invention proposes that if NH3 from exhaled breath can be concentrated on a moistened, pH-sensitive test strip, the pH value of the test strip can be raised, causing the test strip to change color. By observing the color change of the test strip, the presence of *Helicobacter pylori* infection in the subject can be determined. This is precisely the working principle of the *Helicobacter pylori* point-of-care testing device provided by this invention.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] This invention provides a point-of-care testing device for Helicobacter pylori, comprising components such as an air blowing tube, an air filter, and a detection tube. Each component can be made of polypropylene or polyethylene using injection molding or blow molding processes, and can be connected via direct sleeve or threaded interface. Therefore, it has a simple structure and low cost.

[0030] Meanwhile, the air filter is provided on the air outlet side of the air tube described in this utility model, which can effectively prevent water vapor, saliva or oral bacteria and other particulate matter in the exhaled air from splashing onto the test strip and reduce the impact on the test results, thereby improving the accuracy of the test results.

[0031] Secondly, since the NH3 content in human exhaled breath is low under normal circumstances, the NH3 content in the exhaled breath of HP-infected individuals is higher than that of normal subjects. Therefore, this invention proposes that if urea is administered orally to subjects with HP infection, the urease synthesized and secreted by HP in their stomach will decompose the urea to produce CO2 and NH3, which will enter the bloodstream and be exhaled through the alveoli. Furthermore, the test strip used in this invention is a pH-sensitive moistened phenol red test strip or precision pH test strip soaked in purified water with a pH of 7.0. When the subject's exhaled breath passes through the moistened test strip surface in the test tube, the NH3 in the exhaled breath is rapidly adsorbed and dissolved on the moistened test strip, thereby increasing the pH value of the test strip and significantly improving the sensitivity and specificity of the detection.

[0032] Furthermore, the top of the detection tube described in this invention has a unique hollow, flat-topped conical shape, which can effectively concentrate all the NH3 in the subject's exhaled breath onto the test paper inside the double-layer exhaust mesh on the inside of the exhaust port, which has a diameter of only 0.5cm to 1.0cm, and also helps to improve the sensitivity of the detection.

[0033] Furthermore, the detection tube described in this invention has an independently sealed structure, with both the bottom opening and the top vent sealed with a sealing film, effectively preventing moisture evaporation and maintaining the stability of the humidity and pH value of the test strip inside the tube. Moreover, when using this invention, the sealing film on the detection tube opening and vent can be torn open and connected to the breath tube to begin testing immediately. Because moist test strips can more effectively absorb and dissolve NH3 in exhaled breath than dry test strips, the pH value of the moisture on the test strip can be increased more quickly, resulting in a noticeable color change and facilitating the determination of whether the subject has an H. pylori infection.

[0034] Moreover, this invention is a disposable device, eliminating the risk of cross-infection, and the urea capsules used are ordinary urea, so there is no potential risk of radioactive contamination.

[0035] Therefore, the present invention provides a rapid bedside detection device for Helicobacter pylori, which is ingeniously conceived, has a clear working principle, simple structure, low cost, and is easy to use. It requires no special equipment and can be completed entirely by the subject himself.

[0036] Furthermore, the test strip moistened inside the test tube can be phenol red test strip with a pH detection range of 6.8 to 8.0, or precision pH test strip with a pH detection range of 6.4 to 8.0, with phenol red test strip being preferred to improve the sensitivity of the detection.

[0037] Furthermore, the present invention provides a rapid point-of-care testing device for Helicobacter pylori, which can increase the frequency of exhalation by increasing the number of breaths blown by the subject during testing. It is recommended to blow continuously 3 to 5 times each time to increase the total amount of NH3 in the exhaled air, thereby improving the detection sensitivity.

[0038] Furthermore, this invention provides a rapid point-of-care testing device for Helicobacter pylori, which employs a two-step breath test method: First, the subject performs a breath test before ingesting a urea capsule as a negative control, effectively minimizing the influence of individual differences in NH3 content in the subject's breath under natural conditions. Then, the subject immediately ingests the urea capsule and performs another breath test 20-30 minutes later. The color change of the test strips before and after the two tests is compared to improve the accuracy of the test results.

[0039] Furthermore, in addition to its wide applicability in screening for Helicobacter pylori infection, this invention can also be used to assess the risk of hepatic encephalopathy and renal failure and monitor disease progression by detecting NH3 levels in the exhaled breath of patients with advanced liver disease and advanced kidney disease. Therefore, it has broad application prospects. Attached Figure Description

[0040] Figure 1 This is a longitudinal cross-sectional view of a Helicobacter pylori bedside detection device according to the present invention;

[0041] Figure 2 This is a longitudinal cross-sectional view of the detection tube in a Helicobacter pylori bedside detection device of this utility model;

[0042] Among them, 1-air blowing tube; 2-air filter; 3-detection tube; 4-exhaust port; 5-double-layer exhaust mesh; 6-test paper; 7-air blowing port; 8-detection port; 9-air filter element; 10-opening; 11-sealing film. Detailed Implementation

[0043] To enable those skilled in the art to better understand the solutions of this utility model, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this utility model, and not all of them. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort should fall within the protection scope of this utility model.

[0044] It should be noted that the terms "air inlet side," "detection port side," "opening side," "exhaust port side," "bottom," and "top," etc., used in the specification, claims, and accompanying drawings of this utility model indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. These terms are used solely for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "comprising," "having," and any variations thereof are intended to cover non-exclusive inclusion; the terms "connected" and "linked" should be interpreted broadly, for example, they can refer to a fixed connection, a detachable connection, or an integral connection. Those skilled in the art can understand the specific meaning of the above terms in this application according to the actual situation.

[0045] Furthermore, the technical features involved in the different embodiments of this application described above can be combined with each other as long as they do not conflict with each other.

[0046] Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without any creative effort.

[0047] To more clearly illustrate the technical solution of this utility model, a further detailed description is provided below in conjunction with the accompanying drawings. The scope of protection of this utility model is not limited to the following embodiments. Without departing from the spirit and scope of the inventive concept, all variations and advantages that can be conceived by those skilled in the art are included in this utility model and are protected by the appended claims. Except for the content specifically mentioned below, all are common knowledge and general knowledge in the art, and this invention does not contain any particularly limiting content.

[0048] See Figure 1 and Figure 2This utility model includes components such as an air blowing tube 1, an air filter 2, and a detection tube 3. The main bodies of the air blowing tube 1, air filter 2, and detection tube 3 can be made of polypropylene or polyethylene through injection molding or blow molding processes, and can be connected sequentially by direct sleeve or threaded interface. The diameter of the connection port of each component is between 1cm and 2cm, and they are mutually compatible. At the same time, the top of the detection tube 3 is provided with an exhaust port 4 with a diameter of 0.5cm to 1.0cm. A mesh-like double-layer exhaust net 5 is provided inside the exhaust port 4, and a moist pH-sensitive test strip 6 is placed inside the double-layer exhaust net 5.

[0049] The air blowing tube 1 is a hollow, thin-walled cylindrical structure. One end of the air blowing tube 1 is an air blowing port 7, which is a funnel-shaped structure that can match the shape of a human mouth. The diameter of the air blowing tube 1 on the air blowing port side can be slightly larger than the diameter of the main body of the air blowing tube 1 by 3mm to 5mm, for connecting to the air filter 2. The other end of the air blowing tube 1 is a detection port 8, which can be connected to the detection tube 3 by a sleeve connection.

[0050] The air filter 2 has a cylindrical structure, and its outer diameter matches the inner diameter of the air outlet side cavity of the inspection tube 3, so that the air filter 2 can be fitted into the air outlet side cavity of the air blowing tube 1. The air filter 2 has an internal air filter element 9, which can be made of non-woven filter cotton.

[0051] The detection tube 3 has a hollow cylindrical bottom and a hollow flat-top conical top. The bottom of the detection tube 3 has an opening 10, and the inner diameter of the detection tube 3 on the opening side matches the outer diameter of the tube on the detection port 8 side of the air blowing tube 1. It can be directly connected to the detection port 8 of the air blowing tube by means of a direct sleeve connection. The bottom opening 10 and the top exhaust port 4 of the detection tube 3 are sealed with a sealing film 11.

[0052] The moistened pH-sensitive test strip 6 placed inside the double-layer exhaust mesh 5 is phenol red test strip with a pH detection range of 6.8–8.0. First, cut the selected phenol red test strip into square or round pieces slightly smaller than the inner diameter of the exhaust port 4 of the test tube, and soak them in pure water with a pH of 7.0 for 2–3 minutes. Then, use tweezers to pick up a piece of soaked phenol red test strip and place it inside the double-layer exhaust mesh 5. Next, place the double-layer exhaust mesh 5 into the test tube 3, and promptly seal the bottom opening 10 and the top exhaust port 4 of the test tube with sealing film 11. This seals the test tube 3 into an independent sealed structure to maintain the stability of the humidity and pH value of the moistened test strip 6 inside the test tube 3.

[0053] The Helicobacter pylori point-of-care testing device prepared according to the above embodiments is suitable for point-of-care detection of Helicobacter pylori, and the method of use is as follows:

[0054] First test: Before the subject takes the urea capsule orally, take out a set of Helicobacter pylori bedside testing equipment, tear off the sealing film 11 on the bottom opening 10 and the top exhaust port 4 of the test tube, and connect the test tube 3 to the air blowing tube 1. The subject uses the deep breathing method and blows air continuously through the air blowing port 7 3 times. The color change of the test strip 6 is observed and recorded.

[0055] Second test: The subject took one urea capsule (75mg / capsule) orally with 20mL-30mL of warm water. 20-30 minutes later, a set of Helicobacter pylori bedside testing equipment was taken out, the sealing film 11 of the bottom opening 10 and the top exhaust port 4 of the test tube was torn off, and the test tube 3 was connected to the air blowing tube 1. The subject also used the deep breathing method and blew deeply through the air blowing port 7 3 times in a row. The color change of the test strip 6 was observed and recorded.

[0056] Compare the color of test strip 6 after the subject takes urea capsule orally and after the two breath tests. Compare the color of test strip 6 after the second breath test with the standard color chart. If the color of test strip 6 after the second breath test is significantly different from the color of test strip 10 after the first breath test (pH increase greater than ≥0.3), the breath test can be interpreted as positive, that is, the subject has HP infection.

[0057] To evaluate the practical application effect of the Helicobacter pylori bedside testing device provided by this utility model, 62 patients with gastric symptoms who visited the gastroenterology outpatient clinic were selected for a breath test. Simultaneously, with... 14 The C-urea breath test was used as a positive control. Results showed that 38 patients... 14 The C-breath test results were negative in 24 patients. 14 The C-type breath test result was positive. However, the breath test results using the Helicobacter pylori point-of-care testing device provided by this invention showed that 42 patients had negative results and 20 patients had positive results. 14 Of the 24 patients with positive C-breath test results, only 20 patients had positive results using the breath test provided by this invention, while the remaining 4 were negative. Therefore, this invention is comparable to... 14 Compared to the C-urea breath test, the Helicobacter pylori point-of-care testing device provided by this invention has a detection sensitivity of 83.3%, a specificity of 100.0%, a positive predictive value of 100.0%, and a negative predictive value of 90.5%.

[0058] In summary, by using the Helicobacter pylori point-of-care testing device disclosed in this utility model, and following the above-described operation, the subject can complete the HP test independently without any special equipment.

[0059] The above description is merely the technical concept and specific implementation of this utility model, and is not intended to limit this utility model. Any changes or substitutions that can be easily conceived or modified by those skilled in the art based on the technical concept proposed in this utility model, or any alterations made, should fall within the protection scope of the claims of this utility model.

Claims

1. A Helicobacter pylori bedside detection device, comprising an air blowing tube (1), an air filter (2), and a detection tube (3), characterized in that, The blowing tube (1), air filter (2) and detection tube (3) can be made of polypropylene or polyethylene by injection molding or blow molding process, and can be connected by direct sleeve or by threaded interface. The diameter of the connection part of each component is between 1.5cm and 2.0cm and they are matched with each other. The top of the detection tube (3) is provided with an exhaust port (4) with a hole diameter of 0.5cm to 1.0cm. A mesh-like double-layer exhaust net (5) is provided inside the exhaust port (4). A moist pH-sensitive test paper (6) is placed inside the double-layer exhaust net (5).

2. The Helicobacter pylori bedside testing device according to claim 1, characterized in that, The air blowing tube (1) is a hollow tubular structure. One end of the air blowing tube is an air blowing port (7), which is a funnel-shaped or hollow tubular configuration that can match the shape of a person's mouth. The other end of the air blowing tube is a detection port (8), which can be connected to the detection tube (3) by direct sleeve or by threaded interface.

3. The Helicobacter pylori bedside testing device according to claim 1, characterized in that, The air filter (2) is cylindrical in shape, and its outer diameter matches the inner diameter of the air outlet side cavity of the air blowing pipe (1). It can be directly connected to the air outlet side cavity of the air blowing pipe (1). The air filter (2) is provided with an air filter element (9), and the air filter element (9) can be made of one of the following: glass fiber filter cotton, synthetic fiber filter cotton, non-woven filter cotton, or filter paper.

4. The Helicobacter pylori bedside testing device according to claim 1, characterized in that, The detection tube (3) is an independent sealing structure with a hollow cylindrical bottom and a hollow flat-top conical top. The bottom of the detection tube has an opening (10), and the inner diameter of the tube cavity on the opening side matches the outer diameter of the tube body on the detection port (8) side of the air blowing tube (1). It can be connected to the tube body on the detection port (8) side of the air blowing tube (1) by direct sleeve or by threaded interface. The bottom opening (10) and the top exhaust port (4) of the detection tube are sealed with a sealing film (11).

5. The Helicobacter pylori bedside testing device according to claim 1, characterized in that, The test strip (6) is a phenol red test strip with a pH detection range of 6.8 to 8.0 or a precision pH test strip with a pH detection range of 6.4 to 8.

0.

6. The Helicobacter pylori bedside testing device according to claim 4, characterized in that, The sealing film (11) may be made of one or more substrates, such as polypropylene and polyethylene.

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