An aspiration detection system

Abstract

The present invention discloses an aspiration detection system, which relates to the technical field of medical devices. The system includes: a sample collection device for collecting a sample from a patient for detecting aspiration; a sample detection device for detecting the pepsin concentration and amylase concentration in the sample; and an aspiration pre-judgment device for pre-judging whether the patient is likely to aspirate based on at least one of the pepsin concentration and amylase concentration in the sample. The system provided by the embodiments of the present invention pre-judges whether the patient is likely to aspirate by detecting at least one of the pepsin concentration and amylase concentration in the sample from the patient for detecting aspiration, and can pre-judge aspiration as early as possible so as to treat aspiration in time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to an aspiration detection system. Background Art

[0002] Aspiration is the process by which oropharyngeal or gastric contents enter the lower respiratory tract through the glottis. Clinically, it can be divided into overt aspiration and covert aspiration. Overt aspiration refers to the immediate appearance of symptoms such as irritating cough, shortness of breath, cyanosis, and asphyxia after aspiration occurs, followed by complications such as acute bronchitis, bronchial asthma, and aspiration pneumonia (chemical and bacterial). In addition, the presence of gastric contents or food in tracheal secretions or sputum also indicates the occurrence of aspiration; Covert aspiration occurs when there is a small amount of aspiration. At that time, the patient does not have symptoms such as irritating cough and shortness of breath, but long-term and repeated covert aspiration can lead to diseases such as chronic cough, chronic bronchitis, and pulmonary interstitial fibrosis.

[0003] Clinically, the incidence of covert aspiration is higher than that of overt aspiration. Some studies have shown that 71% of elderly patients with community-acquired pneumonia have covert aspiration, the prevalence of aspiration pneumonia in elderly patients with cerebral infarction reaches 60%-90%, 70% of pneumonia patients in the ICU are related to aspiration, and the fatality rate of aspiration pneumonia reaches 40%-60%. The clinical manifestations of aspiration are diverse, ranging from asymptomatic to severe respiratory failure. Covert aspiration is easily missed or misdiagnosed by clinicians. Therefore, early detection and treatment of aspiration are of great significance for the prognosis of patients. Summary of the Invention

[0004] Embodiments of the present invention provide an aspiration detection system to detect and treat aspiration as early as possible.

[0005] An aspiration detection system provided by an embodiment of the present invention includes: a sample collection device for collecting a sample of a patient for detecting aspiration; a sample detection device for detecting the pepsin concentration and amylase concentration in the sample; and an aspiration prediction device for predicting whether the patient may aspirate according to at least one of the pepsin concentration and amylase concentration in the sample.

[0006] Preferably, the sample collection device includes: a sterile container for collecting 3-5 ml of sputum or 3-5 ml of bronchoalveolar lavage fluid of the patient.

[0007] Preferably, the sample detection device includes: a pretreatment module for pretreating the sample to obtain a supernatant of the sample; a pepsin detection module for measuring the pepsin in the supernatant of the sample to obtain a pepsin concentration; and an amylase detection module for measuring the amylase in the supernatant of the sample to obtain an amylase concentration.

[0008] Preferably, the aspiration prediction device includes: a first comparison module for comparing the pepsin concentration with a preset pepsin concentration threshold; a second comparison module for comparing the amylase concentration with a preset amylase concentration threshold; an aspiration prediction module for determining that the patient may have aspiration when the pepsin concentration is greater than or equal to the preset pepsin concentration threshold and / or the amylase concentration is greater than or equal to the preset amylase concentration threshold, and determining that the patient does not have aspiration when the pepsin concentration is less than the preset pepsin concentration threshold and the amylase concentration is less than the preset amylase concentration threshold.

[0009] Preferably, the system further includes: a first aspiration determination device for determining whether food enters the airway and stays below the vocal tract during the patient's eating after the aspiration prediction device determines that the patient may have aspiration, and judging whether the patient has aspiration according to the determination result.

[0010] Preferably, the first aspiration determination device includes: an image acquisition module for acquiring the pharyngeal cavity image and the subglottic airway staining image after the patient swallows during the patient's eating of the paste food stained with methylene blue by using a fiberoptic nasopharyngolaryngoscope; an image analysis module for analyzing the pharyngeal cavity image to determine whether the food stays below the vocal cords, and analyzing the subglottic airway staining image to determine whether the food enters the airway; an aspiration determination module for determining that the patient has aspiration when it is determined that the food is below the vocal cords and the food enters the airway.

[0011] Preferably, the aspiration determination module is further configured to determine that the patient may have aspiration when it is determined that the food does not enter the airway, or when it is determined that the food does not stay below the vocal cords and the food enters the airway.

[0012] Preferably, the system further includes: a second aspiration determination device for performing a radionuclide scan on the patient after the first aspiration determination device determines that the patient may have aspiration to determine whether the patient has aspiration.

[0013] Preferably, the second aspiration determination device includes: a dynamic image acquisition module, configured to perform a radionuclide scan on the patient during the free swallowing by the patient in the supine position of the pigment and radionuclide solution pumped into the oral cavity by a micropump, to obtain a first set of dynamic images; a static image acquisition module, configured to perform a radionuclide scan on the patient after obtaining the first set of dynamic images and after the patient in the supine position has rested for a specified time, to obtain a first set of static images; a radionuclide imaging analysis module, configured to analyze the first set of dynamic images and the first set of static images, to determine whether there is radionuclide imaging in the bronchi and lungs of the patient, and if there is radionuclide imaging in the bronchi and / or lungs of the patient, it is determined that the patient has aspiration.

[0014] Preferably, after determining that there is no radionuclide imaging in the bronchi and / or lungs of the patient by analyzing the first set of dynamic images and the first set of static images, the dynamic image acquisition module is further configured to perform a radionuclide scan on the patient during the free swallowing by the patient in the sitting position of the pigment and radionuclide solution pumped into the oral cavity by a micropump, to obtain a second set of dynamic images; the static image acquisition module is further configured to perform a radionuclide scan on the patient after obtaining the second set of dynamic images and after the patient in the sitting position has rested for a specified time, to obtain a second set of static images; the radionuclide imaging analysis module is further configured to analyze the second set of dynamic images and the second set of static images, to determine whether there is radionuclide imaging in the bronchi and lungs of the patient, and if there is radionuclide imaging in the bronchi and / or lungs of the patient, it is determined that the patient has aspiration, otherwise it is determined that the patient does not have aspiration.

[0015] The system provided by the embodiment of the present invention pre-judges whether the patient may have aspiration by detecting at least one of the pepsin concentration and amylase concentration in the sample for aspiration of the patient, and can pre-judge aspiration as early as possible so as to timely treat aspiration. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is a structural block diagram of an aspiration detection system provided by the first embodiment of the present invention;

[0017] Figure 2 is Figure 1 the aspiration detection flowchart of the shown system;

[0018] Figure 3 is a structural block diagram of an aspiration detection system provided by the second embodiment of the present invention;

[0019] Figure 4 is Figure 3 the aspiration detection flowchart of the shown system;

[0020] Figure 5 It is a structural block diagram of an aspiration detection system provided by the third embodiment of the present invention;

[0021] Figure 6 is Figure 5 The aspiration detection flowchart of the system shown. Specific embodiments

[0022] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings. It should be understood that the preferred embodiments described below are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0023] Figure 1 It is a structural block diagram of an aspiration detection system provided by the first embodiment of the present invention, as Figure 1 shown, the system may include:

[0024] A sample collection device 10 for collecting samples for detecting aspiration of a patient;

[0025] A sample detection device 20 for detecting the concentrations of pepsin and amylase in the sample;

[0026] An aspiration pre-judgment device 30 for pre-judging whether the patient may aspirate according to at least one of the concentrations of pepsin and amylase in the sample.

[0027] Among them, the sample collection device 10 includes a sterile container for collecting 3-5 ml of sputum or 3-5 ml of bronchoalveolar lavage fluid of the patient. In one embodiment, the sample is sputum and the sterile container is a screw-cap sterile plastic bottle. Specifically, the patient samples on an empty stomach in the morning as a routine. Before expectorating sputum, the patient should thoroughly clean the oral cavity, such as gargling, brushing teeth, etc. Patients with dentures should remove the dentures. Instruct the patient to cough up deep sputum forcefully, and do not regard saliva and postnasal secretions as sputum. Collect 3-5 mL of sputum with a screw-cap sterile plastic bottle. In another embodiment, the sample is bronchoalveolar lavage fluid and the sterile container is a sterile container with a screw cap. Specifically, the doctor determines the segment for aspiration sampling based on clinical suspicion, chest radiograph, and bronchoscopy findings, performs local anesthesia, embeds the tip of the bronchoscope at the opening of the target bronchial segment or sub-segment, rapidly injects sterile normal saline at 37 °C or room temperature through the operating channel multiple times for lavage, 20-50 mL each time, with a total volume of 60-120 mL, and aspirates and recovers with an appropriate negative pressure. The total recovery rate should be ≥30%. Mix the bronchoalveolar lavage fluid collected in several times and collect 3-5 mL of it with a sterile container with a screw cap for examination.

[0028] Among them, the sample detection device 20 includes: a pretreatment module, a pepsin detection module, and an amylase detection module. The pretreatment module is used to pretreat the sample to obtain the supernatant of the sample. In one embodiment, the sample is sputum. Weigh the relatively viscous part of the sputum, add 0.1% DTT (dithiothreitol) twice the volume of the sputum, oscillate in a constant temperature water bath at 37°C for 5 min, then add PBS buffer twice the volume of the sputum, continue to oscillate for 15 - 20 min, filter through a 150-mesh cell sieve, centrifuge at 1500 r / min for 10 min, and aspirate the supernatant. In another embodiment, the sample is bronchoalveolar lavage fluid. Centrifuge at 1,000×g for 20 min and take the supernatant. It should be noted that if the detection cannot be carried out in time, the supernatant should be stored at -20°C or -80°C to avoid repeated freezing and thawing. The pepsin detection module is used to measure the pepsin in the supernatant of the sample to obtain the pepsin concentration. For example, the pepsin detection module uses the ELISA method to measure the pepsin content in the supernatant (the lowest detection limit is 1.27 ng / mL). Specifically, the prepared supernatant is added to the test wells of a 96-well microplate. Add 100 μL of the primary antibody, i.e., the pepsinogen A antibody detection solution, and 100 μL of the secondary antibody, i.e., the biotinylated pepsinogen A antibody detection solution, to each well. Seal the test wells and shake gently, and incubate at 37°C for 30 minutes. Wash the microplate five times, then add 90 μL of TMB (3,3',5,5'-tetramethylbenzidine substrate) solution and allow it to react at 37°C for 10 minutes. Then, add 50 μL of the termination solution (2 mol / L H2SO4 solution), and measure the optical density value with a microplate reader within 10 minutes. Calculate the corresponding sample concentration according to the optical density of the sample. The amylase detection module is used to measure the amylase in the supernatant of the sample to obtain the amylase concentration. For example, use a biochemical analyzer to measure the amylase content in the supernatant. Specifically, insert the detection bottle filled with the supernatant into the sample detection rack of the biochemical analyzer, select the detection item as "116.AMY", input the sample number, and click "Start".

[0029] Among them, the aspiration prediction device 30 includes: a first comparison module, a second comparison module, and an aspiration prediction module. The first comparison module is used to compare the pepsin concentration with a preset pepsin concentration threshold; the second comparison module is used to compare the amylase concentration with a preset amylase concentration threshold; the aspiration prediction module is used to determine that the patient may have aspiration when the pepsin concentration is greater than or equal to the preset pepsin concentration threshold, and / or the amylase concentration is greater than or equal to the preset amylase concentration threshold, and determine that the patient does not have aspiration when the pepsin concentration is less than the preset pepsin concentration threshold and the amylase concentration is less than the preset amylase concentration threshold. Taking the preset pepsin concentration threshold as 200 μg / L and the preset amylase concentration threshold as 1685 IU / L as an example, when the detected pepsin concentration ≥ 200 μg / L and / or amylase concentration ≥ 1685 IU / L, it is prompted that the patient may have aspiration, and when the detected pepsin concentration < 200 μg / L and amylase concentration < 1685 IU / L, it is considered that the patient does not have aspiration.

[0030] Figure 2 Yes Figure 1 The flowchart of aspiration detection of the system shown is as follows Figure 2 As shown, the aspiration detection process of the system is as follows:

[0031] Step S201: The sample collection device 10 collects a sample from the patient for detecting aspiration, such as sputum or bronchoalveolar lavage fluid.

[0032] Step S202: The sample detection device 20 preprocesses the collected sample to obtain the supernatant of the sample.

[0033] Step S203: The sample detection device 20 measures the pepsin content in the supernatant by using the ELISA method to obtain the pepsin concentration.

[0034] Step S204: The sample detection device 20 measures the amylase content in the supernatant by using a biochemical analyzer to obtain the amylase concentration.

[0035] Step S205: The aspiration prediction device 30 compares the pepsin concentration with the preset pepsin concentration threshold, and judges whether the pepsin concentration is less than the preset pepsin concentration threshold. If so, it enters step S206, otherwise it enters step S207.

[0036] Step S206: The aspiration prediction device 30 compares the amylase concentration with the preset amylase concentration threshold, and judges whether the amylase concentration is less than the preset amylase concentration threshold. If so, it enters step S208, otherwise it enters step S207.

[0037] Step S207: The aspiration prediction device 30 determines that the patient may have aspiration.

[0038] Step S208: The aspiration prediction device 30 determines that the patient does not have aspiration.

[0039] In the above steps, step S205 and step S206 can be carried out simultaneously or successively. For example, after determining that the amylase concentration is less than the preset amylase concentration threshold, then determine whether the pepsin concentration is less than the preset pepsin concentration threshold.

[0040] The system provided by the embodiment of the present invention predicts whether the patient may have aspiration based on at least one of the pepsin concentration and the amylase concentration in the sample used to detect aspiration of the patient, and can predict aspiration as early as possible so as to treat aspiration in time.

[0041] Figure 3 It is a structural block diagram of an aspiration detection system provided by the second embodiment of the present invention. As Figure 3 shown, in addition to including Figure 1 the sample collection device 10, the sample detection device 20, and the aspiration prediction device 30 in the first embodiment, the system further includes a first aspiration determination device 40.

[0042] The first aspiration determination device 40 is configured to determine whether the food enters the airway and stays below the vocal tract during the patient's eating process after the aspiration prediction device determines that the patient may have aspiration, and judge whether the patient has aspiration according to the determination result.

[0043] Among them, the first aspiration determination device includes: an image acquisition module, configured to use a fiberoptic nasopharyngolaryngoscope to acquire the pharyngeal cavity image and the subepiglottic lower respiratory tract staining image after the patient swallows during the patient's eating of the paste food stained with methylene blue; an image analysis module, configured to analyze the pharyngeal cavity image to determine whether the food stays below the vocal cords, and analyze the subepiglottic lower respiratory tract staining image to determine whether the food enters the airway; an aspiration determination module, configured to determine that the patient has aspiration when it is determined that the food is below the vocal cords and the food enters the airway, and determine that the patient may have aspiration when it is determined that the food does not enter the airway, or when it is determined that the food does not stay below the vocal cords and the food enters the airway.

[0044] Specifically, for patients suspected of having aspiration, with their consent, a fibro-nasopharyngolaryngoscope examination is performed to further clarify whether aspiration exists. The fibro-nasopharyngolaryngoscope examination is carried out by an otolaryngology clinician who is proficient in fibro-nasopharyngolaryngoscope examination. The patient should fast for 3 hours before the examination. When performing the examination, the patient takes a sitting position, and a cotton swab dipped in 1% tetracaine solution is used to smear the surface of the nasal mucosa for local anesthesia. First, insert the fibro-nasopharyngolaryngoscope through one nostril to the posterior nostril to observe the nasopharynx, and ask the patient to perform swallowing movements to evaluate the function of the soft palate in closing the nasopharyngeal entrance. Then, the fibro-laryngoscope is inserted downward into the oropharynx to observe whether there is retention of secretions in the vallecula epiglottica, piriform fossa, etc., and at the same time observe whether there are structural abnormalities in the pharynx and the position of the epiglottis. The laryngoscope continues to enter the posterior part of the epiglottis to observe whether there are abnormalities in the structure of the larynx, whether there is retention of secretions in the laryngeal vestibule, and whether there is any secretion entering below the vocal cords. Ask the patient to perform swallowing movements, breath-holding, coughing, and pronunciation, and observe the movement of the vocal cords. Subsequently, an eating test is carried out, and the patient eats 1ML, 3ML, and 5ML of water, and 3ML and 5ML of paste food colored with methylene blue respectively, and observe the swallowing initiation speed, the residual in the pharyngeal cavity after swallowing (especially the vallecula epiglottica, piriform fossa), and whether there is subglottic airway staining (signs such as food entering the laryngeal vestibule and aspiration). The otolaryngology clinician can, according to the observed situation, take images of the pharyngeal cavity and subglottic airway staining of the patient after swallowing for the first aspiration determination device to evaluate aspiration based on the residual in the pharyngeal cavity after swallowing (especially the vallecula epiglottica, piriform fossa) and whether there is subglottic airway staining (signs such as food entering the laryngeal vestibule and aspiration). The severity of aspiration is scored using the Penetration-Aspiration Scale (PAS): 1 point = food does not enter the airway; 2 points = food enters the airway and stays above the vocal cords and can be coughed out from the airway; 3 points = food enters the airway and stays above the vocal cords and cannot be coughed out from the airway; 4 points = food enters the airway and touches the vocal cords and can be coughed out from the airway; 5 points = food enters the airway and touches the vocal cords and cannot be coughed out from the airway; 6 points = food enters the airway and passes below the vocal cords and can be coughed into the larynx or outside the airway; 7 points = food enters the airway and passes below the vocal cords and still cannot be coughed out from the airway despite efforts; 8 points = food enters the airway and passes below the vocal cords without coughing. Based on the above scores, the severity of aspiration is divided into three categories: ① No laryngeal penetration: After the swallowing reflex in the pharyngeal phase is initiated, food enters the hypopharynx (PAS = 1, 2, or 4 points); ② Laryngeal penetration (PAS: 3 or 5 points); ③ Aspiration: If the PAS score of any bolus at any consistency ≥ 6 points, the patient is classified as having aspiration. It is further divided into silent aspiration (PAS = 8 points) and overt aspiration (PAS = 6 or 7 points). In short, for 6 - 8 points, that is, food enters the airway and is below the vocal cords, at this time it is determined that the patient has aspiration. For 1 - 5 points, that is, food does not enter the airway, or food does not stay below the vocal cords and food enters the airway, at this time it is determined that the patient may have aspiration.

[0045] Figure 4 YesFigure 3 Flowchart of aspiration detection for the system shown, as Figure 4 shown, the aspiration detection process of the system is as follows:

[0046] Steps S401 - S408 are the same as Figure 2 steps S201 - S208 of

[0047] Step S409: The first aspiration determination device 40 obtains an image of the pharyngeal cavity and an image of the sub - epiglottic lower respiratory tract staining after the patient swallows.

[0048] Step S410: The first aspiration determination device 40 determines whether food has entered the airway and whether it stays below the vocal cords based on the pharyngeal cavity image and the sub - epiglottic lower respiratory tract staining image. If so, go to step S411; otherwise, it is determined that the patient may have aspiration.

[0049] Step S411: The first aspiration determination device 40 determines that the patient has aspiration.

[0050] In this embodiment, by initially screening aspiration patients through detecting pepsin and amylase in the sputum and / or bronchoalveolar lavage fluid of high - risk aspiration populations, and further diagnosing aspiration using a fibro - nasopharyngolaryngoscope, the misdiagnosis rate of aspiration is reduced, that is, the specificity of detection is improved.

[0051] Figure 5 is a structural block diagram of an aspiration detection system provided by the third embodiment of the present invention, as Figure 5 shown, in addition to including Figure 3 the sample collection device 10, sample detection device 20, aspiration pre - judgment device 30, and first aspiration determination device 40 in the second embodiment of

[0052] the system further includes a second aspiration determination device 50.

[0053] Among them, the second aspiration determination device 50 includes: a dynamic image acquisition module, configured to perform radionuclide scanning on the patient during the free swallowing of the pigment and radionuclide solution pumped into the oral cavity by the micropump when the patient is in the supine position, to obtain a first set of dynamic images; a static image acquisition module, configured to perform radionuclide scanning on the patient after obtaining the first set of dynamic images and the patient in the supine position has rested for a specified time, to obtain a first set of static images; a radionuclide imaging analysis module, configured to analyze the first set of dynamic images and the first set of static images to determine whether there is radionuclide imaging in the bronchus and lungs of the patient. If there is radionuclide imaging in the bronchus and / or lungs of the patient, it is determined that the patient has aspiration. After determining that there is no radionuclide imaging in the bronchus and / or lungs of the patient by analyzing the first set of dynamic images and the first set of static images, the dynamic image acquisition module is further configured to perform radionuclide scanning on the patient during the free swallowing of the pigment and radionuclide solution pumped into the oral cavity by the micropump when the patient is in the sitting position, to obtain a second set of dynamic images; the static image acquisition module is further configured to perform radionuclide scanning on the patient after obtaining the second set of dynamic images and the patient in the sitting position has rested for a specified time, to obtain a second set of static images; the radionuclide imaging analysis module is further configured to analyze the second set of dynamic images and the second set of static images to determine whether there is radionuclide imaging in the bronchus and lungs of the patient. If there is radionuclide imaging in the bronchus and / or lungs of the patient, it is determined that the patient has aspiration, otherwise it is determined that the patient does not have aspiration.

[0054] Specifically, for patients with laryngeal infiltration and without laryngeal infiltration, with their consent, radionuclide imaging examination is performed to further exclude aspiration. Instruct the patient to fast on an empty stomach the next morning, clean the oral cavity, prepare a total of 40 ml of edible pigment and technetium 99 Tcm-SC solution (1 - 3 grams of edible pigment and 40 ml of warm water), and place it in a 50 ml syringe. Fix the syringe with a micropump, connect an extension tube. The subject lies on the back with a pillow, place the end of the extension tube on one side of the patient's oral cavity (the parotid gland opening) and fix it; set the pump speed to 40 ml / h (to ensure that the imaging agent is evenly injected into the patient's oral cavity within 60 minutes), and instruct the patient to freely swallow during the examination. For data acquisition, a low-energy general-purpose collimator with a window width of 20%, a matrix of 128*128, and an energy peak of 140 keV is used. The acquisition range is from the oropharynx to the esophagus and stomach, and dynamic imaging is performed every 30 s for a total of 30 min to obtain a first set of dynamic images. After the dynamic imaging is completed, instruct the patient to slowly drink 10 ml of warm water with the head down and rest for 10 min, and then acquire static images for 5 minutes to obtain a first set of static images.

[0055] If there is radionuclide imaging in the first set of dynamic images and / or the first set of static images, i.e., aspiration positive imaging (the radionuclide imaging agent enters the stomach from the oral cavity through the esophagus, and radionuclide imaging can be seen in the left and / or right main bronchi and branches), then the patient is aspiration positive. At this time, the next test can be stopped. If there is no radionuclide imaging in the first set of dynamic images and / or the first set of static images, i.e., aspiration negative imaging (the radionuclide imaging agent enters the stomach from the oral cavity through the esophagus, and no radionuclide imaging is seen in the trachea, bronchi, and lung fields), then the patient is aspiration negative. At this time, the patient changes to a sitting position, and the solution continues to be pumped into the oral cavity at the original speed for 30 minutes to obtain a second set of dynamic images. After the experiment ends, a 5-minute static image is collected again to obtain a second set of static images. If there is radionuclide imaging in the first set of dynamic images and / or the first set of static images, it is determined that the patient is aspiration positive, otherwise it is determined that the patient does not have aspiration.

[0056] Figure 6 Yes Figure 5 The flowchart of aspiration detection of the system shown, as Figure 6 shown, the aspiration detection process of the system is as follows:

[0057] Steps S601 - Steps S611 are the same as Figure 2 Steps S401 - Steps S411 of

[0058] Step S612: The patient is in the supine position and freely swallows the pigment and radionuclide solution pumped into the oral cavity by the micropump. During this period, the second aspiration determination device 50 performs radionuclide scanning on the patient to obtain a first set of dynamic images. After obtaining the first set of dynamic images, the patient rests for a specified time, and then radionuclide scanning is performed on the patient to obtain a first set of static images.

[0059] Step S613: The second aspiration determination device 50 analyzes the first set of dynamic images and the first set of static images to determine whether there is radionuclide imaging in the bronchi and lungs of the patient. If so, go to Step S611 to determine that the patient has aspiration, otherwise go to Step S614.

[0060] Step S614: The patient is in the sitting position and freely swallows the pigment and radionuclide solution pumped into the oral cavity by the micropump. During this period, the second aspiration determination device 50 performs radionuclide scanning on the patient to obtain a second set of dynamic images. After obtaining the second set of dynamic images, the patient rests for a specified time, and then radionuclide scanning is performed on the patient to obtain a second set of static images.

[0061] Step S615: The second aspiration determination device 50 analyzes the second set of dynamic images and the second set of static images to determine whether there is radionuclide imaging in the bronchus and lungs of the patient. If so, go to step S611 to determine that the patient has aspiration; otherwise, go to step S608 to determine that the patient does not have aspiration.

[0062] Currently, the examination methods in the clinical and laboratory research stages and promising for aspiration screening include: pH monitoring, visualization imaging, radioactive tracer labeling, microbiological detection, airway secretion cytology detection, endoscopy, etc. However, there are drawbacks such as low sensitivity (i.e., easy to miss diagnosis during diagnosis) and low specificity (i.e., easy to misdiagnose during diagnosis) when these methods are used alone. In this embodiment, pepsin and amylase in the sputum and / or bronchoalveolar lavage fluid of high-risk aspiration populations are detected to preliminarily screen for aspiration patients, and a fiberoptic nasopharyngolaryngoscope is used to further diagnose aspiration, reducing the misdiagnosis rate of aspiration, that is, improving the specificity of detection. Finally, for patients who are not detected with aspiration by the fiberoptic nasopharyngolaryngoscope, radionuclide detection is used to further rule out aspiration, reducing the missed diagnosis rate of aspiration, that is, improving the sensitivity of detection.

[0063] Although the present invention has been described in detail above, the present invention is not limited thereto, and those skilled in the art of this technology can make various modifications according to the principles of the present invention. Therefore, all modifications made according to the principles of the present invention should be understood to fall within the protection scope of the present invention.

Claims

1. An aspiration detection system, characterized in that, The system includes: A sample collection device for collecting samples from a patient for detecting aspiration; A sample detection device for detecting the concentration of pepsin for predicting aspiration and the concentration of amylase for predicting aspiration in the sample; An aspiration prediction device, including an aspiration prediction module, for predicting whether the patient may have aspiration based on the pepsin concentration and the amylase concentration. Wherein, when the pepsin concentration is greater than or equal to a preset pepsin concentration threshold, and / or, the amylase concentration is greater than or equal to a preset amylase concentration threshold, it is determined that the patient may have aspiration; when the pepsin concentration is less than the preset pepsin concentration threshold and the amylase concentration is less than the preset amylase concentration threshold, it is determined that the patient does not have aspiration; A first aspiration determination device for determining whether food enters the airway and stays below the vocal tract during the patient's eating after the aspiration prediction device predicts that the patient may have aspiration, and when it is determined that the food is below the vocal cords and the food enters the airway, it is determined that the patient has aspiration, reducing the misdiagnosis rate of the aspiration prediction device for diagnosing aspiration. When it is determined that the food does not enter the airway, or when it is determined that the food enters the airway but does not stay below the vocal cords, it is determined that the patient who has not been detected with aspiration may have aspiration; A second aspiration determination device for performing a radionuclide scan on the patient after the first aspiration determination device determines that the patient who has not been detected with aspiration may have aspiration, and further determining whether the patient who has not been detected with aspiration by the first aspiration determination device but may have aspiration has aspiration, so as to reduce the missed diagnosis rate of the first aspiration determination device for diagnosing aspiration.

2. The system according to claim 1, wherein The sample is sputum or bronchoalveolar lavage fluid, and the sample collection device includes: A sterile container for collecting 3 - 5 ml of sputum or 3 - 5 ml of bronchoalveolar lavage fluid from the patient.

3. The system according to claim 1, wherein The sample detection device includes: A pretreatment module for pretreating the sample to obtain the supernatant of the sample; A pepsin detection module for measuring the pepsin in the supernatant of the sample to obtain the pepsin concentration; An amylase detection module for measuring the amylase in the supernatant of the sample to obtain the amylase concentration.

4. The system according to claim 1, wherein The aspiration prediction device further includes: A first comparison module for comparing the pepsin concentration with a preset pepsin concentration threshold; A second comparison module for comparing the amylase concentration with a preset amylase concentration threshold.

5. The system according to claim 1, characterized in that, The first aspiration determination device includes: An image acquisition module for using a fiberoptic nasopharyngolaryngoscope to obtain the pharyngeal cavity image and the subepiglottic lower respiratory tract staining image after the patient swallows during the patient's eating of blue - colored paste food; An image analysis module for analyzing the pharyngeal cavity image to determine whether the food stays below the vocal cords, and analyzing the subepiglottic lower respiratory tract staining image to determine whether the food enters the airway; An aspiration determination module for determining that the patient has aspiration when it is determined that the food is below the vocal cords and the food enters the airway.

6. The system according to claim 1, wherein The second aspiration determination device includes: A dynamic image acquisition module, configured to perform a radionuclide scan on the patient during the free swallowing by the patient in the supine position of the pigment and radionuclide solution pumped into the oral cavity by a micropump, so as to obtain a first set of dynamic images; A static image acquisition module, configured to perform a radionuclide scan on the patient after obtaining the first set of dynamic images and after the patient in the supine position has rested for a specified time, so as to obtain a first set of static images; A radionuclide imaging analysis module, configured to analyze the first set of dynamic images and the first set of static images to determine whether there is radionuclide imaging in the bronchi and lungs of the patient. If there is radionuclide imaging in the bronchi and / or lungs of the patient, it is determined that the patient has aspiration.

7. The system according to claim 6, wherein, The dynamic image acquisition module is further configured to, after determining that there is no radionuclide imaging in the bronchi and / or lungs of the patient by analyzing the first set of dynamic images and the first set of static images, perform a radionuclide scan on the patient during the free swallowing by the patient in the sitting position of the pigment and radionuclide solution pumped into the oral cavity by a micropump, so as to obtain a second set of dynamic images; The static image acquisition module is further configured to perform a radionuclide scan on the patient after obtaining the second set of dynamic images and after the patient in the sitting position has rested for a specified time, so as to obtain a second set of static images; The radionuclide imaging analysis module is further configured to analyze the second set of dynamic images and the second set of static images to determine whether there is radionuclide imaging in the bronchi and lungs of the patient. If there is radionuclide imaging in the bronchi and / or lungs of the patient, it is determined that the patient has aspiration; otherwise, it is determined that the patient does not have aspiration.

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