A Helicobacter pylori screening system

Abstract

The present invention discloses a Helicobacter pylori screening system, belonging to the field of medical equipment technology, comprising a gas sampling unit and a characteristic detection unit; the gas sampling unit comprises an air blowing nozzle and a sampling tube, one end of the sampling tube being connected to the air blowing nozzle, and the other end of the sampling tube being connected to the characteristic detection unit; the characteristic detection unit comprises a photoacoustic spectrometer and an infrared spectrometer, the photoacoustic spectrometer being used to detect the concentration of characteristic gases in a subject, and the infrared spectrometer being used to detect the concentration of volatile organic compounds in a subject. In the present invention, the characteristic gases and organic volatile compound concentrations used to determine whether a subject has Helicobacter pylori can be collected from the subject's exhaled breath by using the photoacoustic spectrometer and the infrared spectrometer, respectively. This allows Helicobacter pylori infection screening to be achieved without the need for oral administration of any auxiliary tablets, thereby reducing the psychological burden on patients and improving test compliance.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a Helicobacter pylori screening system. Background Art

[0002] Helicobacter pylori (Hp) is the main pathogen of chronic gastritis, peptic ulcer and gastric cancer. Currently, the commonly used clinical detection methods include: urea breath test (UBT): the subject needs to take an oral 13 C or 14 C-labeled urea capsules detect infection by detecting labeled CO2 in exhaled breath. Although UBT has high sensitivity, it has significant drawbacks: 14 C is radioactive and is prohibited for pregnant women and children; 13 Although C does not cause radiation, the testing cost is high, the waiting time is long, the process is cumbersome, and it relies on medication. Patient compliance is poor, and it is especially unfriendly to children, the elderly, and people who are resistant to medication. Summary of the Invention

[0003] The purpose of the present invention is to solve the above-mentioned technical problems and provide a Helicobacter pylori screening system. Through a photoacoustic spectrometer and an infrared spectrometer, the characteristic gases and organic volatile concentrations in the exhaled breath of the subject can be detected respectively. Later, the collected characteristic gases and organic volatile concentrations can be used to determine whether the subject is suffering from Helicobacter pylori. Helicobacter pylori infection screening can be achieved without the need for oral administration of any auxiliary tablets.

[0004] To achieve the above-mentioned object, the present invention provides the following solutions: The present invention discloses a Helicobacter pylori screening system, comprising a gas sampling unit and a characteristic detection unit;

[0005] The gas sampling unit includes an air blowing nozzle and a sampling tube, one end of the sampling tube is connected to the air blowing nozzle, and the other end of the sampling tube is connected to the feature detection unit;

[0006] The characteristic detection unit includes a photoacoustic spectrometer and an infrared spectrometer. The photoacoustic spectrometer is used to detect the detection concentration of the characteristic gas of the subject, and the infrared spectrometer is used to detect the detection concentration of volatile organic compounds of the subject.

[0007] Preferably, an analysis and comparison unit is also included, which includes an analysis device, and the photoacoustic spectrometer and the infrared spectrometer are both electrically connected to the analysis device. The analysis device is provided with a database and analysis software, and the database is provided with threshold concentrations of disease characteristics, and the threshold concentrations include characteristic gas concentration thresholds and volatile organic compound concentration thresholds. The analysis software can compare the detected concentration with the threshold concentration.

[0008] Preferably, the characteristic gas includes ammonia, and the volatile organic compounds include octanoic acid, acetic acid and styrene.

[0009] Preferably, it also includes a hyperspectral detection unit, which includes a hyperspectral detector for detecting the spectral information of the subject's tongue, face, and eyes. The hyperspectral detector is electrically connected to the analysis device. The database also includes the spectral information of the tongue, face, and eyes of the patient. The analysis software can compare the spectral information of the subject with the spectral information of the patient.

[0010] Preferably, the sampling tube is provided with an air pump.

[0011] Preferably, the suction flow rate of the suction pump is 0-10 L / min.

[0012] Preferably, the air suction pump is located between the air blowing nozzle and the feature detection unit, and a flow meter is also provided between the air suction pump and the feature detection unit.

[0013] Preferably, the flow meter is a multifunctional flow meter capable of monitoring flow and controlling gas flow rate.

[0014] Preferably, the blowing nozzle is made of medical-grade silicone material, and the sampling tube is made of polytetrafluoroethylene material.

[0015] Preferably, the sampling tube is equipped with a heating system, and the temperature of the tube wall of the sampling tube is maintained at 30° C. to 50° C. through the regulation of the heating system.

[0016] Compared with the prior art, the present invention has achieved the following technical effects:

[0017] In the present invention, a photoacoustic spectrometer and an infrared spectrometer can be used to collect characteristic gases and organic volatile compound concentrations from the subject's exhaled breath for determining whether the subject is suffering from Helicobacter pylori. Later, based on the collected characteristic gases and organic volatile compound concentrations, it can be determined whether the subject is suffering from Helicobacter pylori. Helicobacter pylori infection screening can be achieved without the need for oral administration of any auxiliary tablets, thereby reducing the patient's psychological burden and improving test compliance. In addition, two parameters, the concentration of volatile organic compounds and the concentration of characteristic gases, are collected at the same time. Compared with collecting only the single parameter of characteristic gases, misdiagnosis can be reduced when provided to doctors for reference and judgment in the later stage.

[0018] Compared with the prior art, other solutions of the present invention also achieve the following technical effects:

[0019] In the present invention, a hyperspectral detector can detect the spectral information of the subject's tongue, face, and eyes, and the spectral information of the subject can be compared with the spectral information of the patient through analysis software. When the detection concentration values of characteristic gases and volatile organic compounds do not reach the threshold but are close to the threshold, it is difficult for the doctor to give a diagnosis result. A comprehensive judgment can be made based on the comparison results of the tongue, face, and eye spectral information to determine whether the subject is sick, further increasing the number of parameters for diagnosis, thereby improving the accuracy of later diagnosis and avoiding misdiagnosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the analysis of these drawings without paying any creative work.

[0021] Figure 1 Schematic diagram of the structure of the Helicobacter pylori screening system in an embodiment of the present invention;

[0022] Figure 2 A schematic diagram of a database establishment process in an embodiment of the present invention;

[0023] Figure 3 Schematic diagram of the decision logic in an embodiment of the present invention.

[0024] Explanation of the accompanying symbols: 1. Air blowing nozzle; 2. Sampling tube; 3. Air pump; 4. Flow meter; 5. Photoacoustic spectrometer; 6. Infrared spectrometer; 7. Analysis equipment; 8. Hyperspectral detector; 9. Database; 10. Analysis software. DETAILED DESCRIPTION

[0025] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments analyzed and obtained by ordinary technicians in this field without making any creative efforts shall fall within the scope of protection of the present invention.

[0026] The purpose of the present invention is to provide a Helicobacter pylori screening system to solve the problems existing in the prior art. Through a photoacoustic spectrometer and an infrared spectrometer, the concentrations of characteristic gases and organic volatiles in the exhaled breath of the subject can be detected respectively. Helicobacter pylori infection screening can be achieved without the need for oral administration of any auxiliary tablets, thereby reducing the psychological burden of patients and improving detection compliance. In addition, the two parameters of the concentration of volatile organic compounds and the concentration of characteristic gases are collected. Compared with collecting only the single parameter of characteristic gases, misdiagnosis can be reduced when used as a reference for diagnosis in the later stage.

[0027] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0028] like Figures 1 to 3 As shown, this embodiment provides a Helicobacter pylori screening system, including a gas sampling unit and a feature detection unit;

[0029] The gas sampling unit includes an air blowing nozzle 1 and a sampling tube 2. One end of the sampling tube 2 is connected to the air blowing nozzle 1, and the other end of the sampling tube 2 is connected to the feature detection unit.

[0030] The characteristic detection unit includes a photoacoustic spectrometer 5 and an infrared spectrometer 6. The photoacoustic spectrometer 5 is used to detect the detection concentration of the characteristic gas of the subject, and the infrared spectrometer 6 is used to detect the detection concentration of volatile organic compounds of the subject.

[0031] Working principle:

[0032] The subject blows air through the mouthpiece 1, and the sampling tube 2 sends the subject's air to the photoacoustic spectrometer 5 and the infrared spectrometer 6 for detection. The photoacoustic spectrometer 5 can detect the concentration of the subject's characteristic gas, and the infrared spectrometer 6 can detect the concentration of the subject's volatile organic compounds. Subsequently, by simply comparing the detected concentrations of the characteristic gas and the volatile organic compounds with the concentration thresholds of the characteristic gas and the volatile organic compounds, it can be determined whether the subject has Helicobacter pylori. Helicobacter pylori infection screening can be achieved without the need for oral administration of any auxiliary tablets.

[0033] Specifically, when comparing, the concentration comparison of characteristic gases is the core judgment parameter, and the concentration comparison of volatile organic compounds is the auxiliary judgment parameter. For example, when the characteristic gas is greater than or equal to the threshold, and the volatile organic compounds are greater than, equal to, or slightly lower than the threshold, it can be determined that the patient has Helicobacter pylori; when the characteristic gas is slightly lower than the threshold, and the volatile organic compounds are greater than or equal to the threshold, it is also determined that the patient has Helicobacter pylori. Using the concentration comparison of volatile organic compounds to assist the judgment of the concentration comparison of characteristic gases can avoid misdiagnosis caused by single gas comparison. Although photoacoustic spectroscopy (PAS) has the advantages of high sensitivity (ppb level) and label-free detection, it is gradually applied to the field of trace gas analysis. However, single gas indicators are easily affected by diet, oral flora and environment, resulting in a high false positive rate. For example, a high-protein diet or oral bacterial metabolism may produce gas components similar to Hp infection, affecting the specificity of detection. The auxiliary judgment method of volatile organic compounds can reduce misdiagnosis results.

[0034] The idea of using volatile organic compounds (VOCs) to determine whether a subject has Helicobacter pylori was inspired by Traditional Chinese Medicine (TCM) auscultation, which can detect odor characteristics such as "putrid" and "sour" in a patient's breath to assist in the diagnosis of gastrointestinal diseases, as described in the Yellow Emperor's Classic of Internal Medicine: "Stomach heat causes bad breath." However, traditional auscultation relies on the physician's subjective experience and lacks objective quantitative standards. Furthermore, these odor characteristics are difficult to determine using instruments. Therefore, the present invention proposes identifying VOCs that produce odors such as "putrid" and "sour," and then determining whether a subject has Helicobacter pylori by measuring the concentration of these VOCs in the subject's exhaled breath. To this end, the present invention uses infrared spectroscopy to examine a large number of breath samples from patients and healthy subjects. The breath samples are then compared to obtain spectral information about VOCs unique to the patient and those that are significantly higher in the patient than in the healthy subject. This information is then combined with TCM auscultation to obtain the spectral information required for breath diagnosis.

[0035] The characteristic gas can be determined by collecting and comparing breath samples from a large number of healthy subjects and patients using photoacoustic spectroscopy technology to determine the characteristic gas threshold.

[0036] In one embodiment, an analysis and comparison unit is also included, and the analysis and comparison unit includes an analysis device 7, and the photoacoustic spectrometer 5 and the infrared spectrometer 6 are electrically connected to the analysis device 7. The analysis device 7 is provided with a database 9 and analysis software 10, and the database 9 is provided with a threshold concentration of the disease characteristics, and the threshold concentration includes a characteristic gas concentration threshold and a volatile organic compound concentration threshold. The analysis software 10 can compare the detection concentration and the threshold concentration and output the comparison result. The doctor can then know whether the subject has Helicobacter pylori based on the comparison result. When establishing the database 9, it can be divided into a traditional Chinese medicine odor fingerprint map and a characteristic gas map. The traditional Chinese medicine odor fingerprint map mainly includes the spectral information (volatile organic compound threshold) required for exhaled breath diagnosis and the spectral information of the characteristic gas (characteristic gas threshold).

[0037] In one embodiment, the characteristic gas mainly includes ammonia. Volatile organic compounds mainly include octanoic acid, acetic acid and styrene. Specifically, when the detected concentration of ammonia is ≥ the threshold concentration (usually 3.2 ppm), octanoic acid, acetic acid and styrene are greater than or equal to or slightly lower than the threshold, it is judged to be suffering from Helicobacter pylori infection; and when the concentration of ammonia is slightly lower than the threshold, but the concentration thresholds of volatile organic compounds are met, for example, octanoic acid ≥ 0.8pp, acetic acid ≥ 12.6ppb and styrene ≥ 0.3ppb, it is also judged to be suffering from Helicobacter pylori infection. The above are threshold values and judgment methods, which are based on the current test results and can be verified and adjusted according to actual conditions. Slightly lower than means that the threshold is not reached, but close to the threshold.

[0038] In one embodiment, the system further includes a hyperspectral detection unit, comprising a hyperspectral detector 8 for detecting spectral information of the subject's tongue, face, and eyes. The hyperspectral detector 8 is electrically connected to the analysis device 7. A database 9 also includes spectral information of the tongue, face, and eyes of patients. Analysis software 10 is capable of comparing the subject's spectral information with that of patients and outputting comparison results, such as a degree of similarity. A doctor can compare the degree of similarity with a preset degree of similarity. If the degree of similarity is greater than or equal to the preset degree of similarity, a diagnosis is made. This preset degree of similarity can be set based on extensive clinical experience. Thus, when the detected concentrations of characteristic gases and volatile organic compounds do not reach a threshold but are close to the threshold, making it difficult for the doctor to make a diagnosis, a multimodal comparison of the tongue, face, and eye spectral information can be combined to determine whether the subject is ill, thereby improving accuracy. The spectral information of the tongue, face, and eyes of patients in database 9 is pre-captured and generated using the hyperspectral detector 8. The hyperspectral detector 8 can non-invasively collect spectral information from a subject's tongue, face, and eyes. This is accomplished by taking hyperspectral photographs of the subject's or patient's tongue, face, and eyes. Each pixel in the hyperspectral photograph contains spectral information. A convolutional neural network is then used to extract H. pylori infection signatures. The hyperspectral detector 8 is an existing device, and its operating principle will not be elaborated upon here.

[0039] In one embodiment, a vacuum pump 3 is provided on the sampling tube 2 , and the vacuum pump 3 is used to extract gas, providing power for gas flow, so that the gas can flow smoothly into the photoacoustic spectrometer 5 and the infrared spectrometer 6 .

[0040] In one embodiment, the suction flow rate of the suction pump 3 is 0-10 L / min, which is verified to be lower than the average blowing speed of the subjects, thereby preventing the introduction of air.

[0041] In one embodiment, the air pump 3 is located between the air blowing nozzle 1 and the characteristic detection unit. A flow meter 4 is also provided between the air pump 3 and the characteristic detection unit, and the flow meter 4 can monitor the gas flow.

[0042] In one embodiment, the flow meter 4 is a multifunctional flow meter capable of monitoring flow and controlling gas flow rate, so as to ensure that the gas is input into the characteristic detection unit at a uniform speed while monitoring the flow rate. The multifunctional flow meter is, for example, a mass flow controller.

[0043] In one embodiment, the insufflation nozzle 1 is made of medical-grade silicone and is disposable. The sampling tube 2 is made of polytetrafluoroethylene (PTFE). PTFE is resistant to acids, alkalis, and various organic solvents, reducing the adsorption of volatile organic compounds and ammonia by the tube. Of course, the insufflation nozzle 1 and sampling tube 2 may also be made of other materials with lower adsorption properties.

[0044] In one embodiment, the inner diameter of the sampling tube 2 is 3 mm to 8 mm.

[0045] In one embodiment, the sampling tube 2 is equipped with a heating system. The heating system regulates the temperature of the tube wall of the sampling tube 2 to maintain between 30°C and 50°C, thereby preventing volatile organic compounds in the breath from condensing or adsorbing on the tube wall. The heating system may utilize an electric heating wire with temperature control capabilities.

[0046] In one embodiment, the method for detecting Helicobacter pylori is as follows:

[0047] Step 1: The subject blows air through the mouthpiece 1 and exhales continuously for several seconds (usually 10-15 seconds). The air pump 3 is activated to introduce the exhaled breath sample into the characteristic detection unit. The characteristic detection unit's photoacoustic spectrometer 5 collects the characteristic gas concentration in the exhaled breath sample, and the infrared spectrometer 6 collects the concentration of volatile organic compounds. At the same time, the hyperspectral detector 8 collects spectral information of the subject's tongue, face, and eyes.

[0048] Step 2: After the analysis device 7 receives the detected concentrations of the characteristic gases, the detected concentrations of the volatile organic compounds, and the spectral information of the tongue, face, and eyes of the subject, the analysis software 10 retrieves the threshold concentrations of the characteristic gases, the threshold concentrations of the volatile organic compounds, and the spectral information of the tongue, face, and eyes of the patient from the database 9, compares the threshold concentrations with the detected concentrations, and provides a first comparison result. The analysis software 10 also compares the spectral information of the tongue, face, and eyes of the subject and the patient, and provides a second comparison result.

[0049] Step 3: The doctor gives an improved diagnosis result based on the first comparison result and the second comparison result.

[0050] This process does not require the subjects to take any isotope-labeled or unlabeled auxiliary tablets orally, achieving rapid screening without medication and radiation. Practical verification shows that the average detection time is less than 10 minutes, and the single cost is less than 20% of the urea breath test (UBT). It is suitable for medical institutions at all levels and family health management.

[0051] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and core concept of the present invention. At the same time, those skilled in the art will find that the specific implementation methods and application scopes may vary based on the concept of the present invention. In summary, the contents of this specification should not be construed as limiting the present invention.

Claims

1. A Helicobacter pylori screening system, characterized in that: It includes a gas sampling unit and a characteristic detection unit; The gas sampling unit includes an air blowing nozzle and a sampling tube, one end of the sampling tube is connected to the air blowing nozzle, and the other end of the sampling tube is connected to the feature detection unit; The characteristic detection unit includes a photoacoustic spectrometer and an infrared spectrometer, wherein the photoacoustic spectrometer is used to detect the detection concentration of the characteristic gas of the subject, and the infrared spectrometer is used to detect the detection concentration of volatile organic compounds of the subject; The system further includes an analysis and comparison unit, the analysis and comparison unit including an analysis device, the photoacoustic spectrometer and the infrared spectrometer being electrically connected to the analysis device, the analysis device being provided with a database and analysis software, the database being provided with threshold concentrations of disease characteristics, the threshold concentrations including characteristic gas concentration thresholds and volatile organic compound concentration thresholds, and the analysis software being capable of comparing the detected concentrations with the threshold concentrations; The system further includes a hyperspectral detection unit, the hyperspectral detection unit including a hyperspectral detector for detecting spectral information of the tongue, face, and eyes of the subject, the hyperspectral detector being electrically connected to the analysis device, the database also including spectral information of the tongue, face, and eyes of the patient, and the analysis software being capable of comparing the spectral information of the subject with the spectral information of the patient; When the gas detection concentration is greater than or equal to the characteristic gas concentration threshold, and the volatile organic compound detection concentration is greater than, equal to, or lower than but close to the volatile organic compound concentration threshold, it is determined that the patient has Helicobacter pylori infection; When the detected gas concentration is lower than but close to the characteristic gas concentration threshold, and the detected volatile organic compound concentration is greater than or equal to the volatile organic compound concentration threshold, it is also determined that the person suffers from Helicobacter pylori infection.

2. The Helicobacter pylori screening system according to claim 1, characterized in that: The characteristic gas includes ammonia, and the volatile organic compounds include octanoic acid, acetic acid, and styrene.

3. The Helicobacter pylori screening system according to claim 1, characterized in that: An air pump is provided on the sampling tube.

4. The Helicobacter pylori screening system according to claim 3, characterized in that: The suction flow rate of the suction pump is 0-10 L / min.

5. The Helicobacter pylori screening system according to claim 4, characterized in that: The air suction pump is located between the air blowing nozzle and the feature detection unit, and a flow meter is also provided between the air suction pump and the feature detection unit.

6. The Helicobacter pylori screening system according to claim 5, characterized in that: The flow meter is a multifunctional flow meter capable of monitoring flow and controlling gas flow rate.

7. The Helicobacter pylori screening system according to claim 1, characterized in that: The blowing nozzle is made of medical grade silicone material, and the sampling tube is made of polytetrafluoroethylene material.

8. The Helicobacter pylori screening system according to claim 1 or 7, characterized in that: The sampling tube is equipped with a heating system, and the temperature of the tube wall of the sampling tube is maintained at 30° C. to 50° C. through the regulation of the heating system.

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