Minimally invasive portal vein pressure home detection kit

Abstract

The utility model belongs to the technical field of portal vein pressure detection, and discloses a minimally invasive portal vein pressure home detection kit which comprises a rubber plate, a sample pad, a colloidal gold combination pad, a chromatography membrane and a water absorption layer, wherein the sample pad, the colloidal gold combination pad, the chromatography membrane and the water absorption layer are arranged at the upper end of the colloidal plate, the sample pad, the colloidal gold combination pad, the chromatography membrane and the water absorption layer are sequentially connected, a detection line and a quality control line are arranged on the chromatography membrane, and a GP73 colloidal gold marker is arranged on the colloidal gold combination pad. The minimally invasive portal vein pressure home detection kit is simple to operate and low in use cost, and a patient can obtain a non-invasive and real-time portal vein pressure prediction value in a home environment.

Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of portal vein pressure detection, especially to a minimally invasive portal vein pressure home detection kit. BACKGROUND

[0002] The portal vein pressure can be measured by medical examinations such as abdominal puncture, echocardiography, liver elasticity determination, portal blood flow velocity detection, and portal angiography. Abdominal puncture can measure the amount and pressure of ascites to assess the degree of portal hypertension. The doctor will find the thickest place of effusion on the patient's abdomen and use a thin needle to extract a small amount of ascites for analysis. Echocardiography can show the structure of the heart and blood flow, which helps to diagnose whether portal hypertension is caused by right heart disease. The patient lies on the examination bed in supine position, and the doctor will use high-frequency sound waves to scan the patient's heart area. Liver elasticity determination assesses the degree of liver fibrosis and portal hypertension by measuring the hardness of liver tissue. The patient lies flat on the examination bed, and after selecting the point by palpation in the non-fat part, the measurement is carried out. Portal blood flow velocity detection can directly reflect the pressure changes in the portal system, which has diagnostic significance for portal hypertension. Usually, a sample is collected and data is recorded by inserting a catheter into the inferior vena cava below the left lobe of the liver through the jugular vein. Portal angiography is an interventional examination method that can directly observe the condition of the portal vein and its branches, helping to determine whether there are problems such as stenosis or dilation. A thin and soft guide wire is inserted into the femoral artery and guided into a microcatheter to the predetermined position, and iodine contrast agent is injected under X-ray monitoring.

[0003] Therefore, the current portal vein pressure detection method has high technical requirements and high cost, and is only carried out in a few centers, resulting in high cost of portal vein pressure detection and limited clinical promotion. UTILITY MODEL CONTENT

[0004] In view of the above-mentioned shortcomings of the prior art, the purpose of the utility model is to provide a minimally invasive portal vein pressure home detection kit, so that patients can obtain non-invasive and real-time portal pressure prediction values in a home environment.

[0005] The technical solution of the utility model is:

[0006] A minimally invasive portal vein pressure home detection kit, comprising a rubber plate, a sample pad, a colloidal gold combination pad, a chromatography membrane, and a water absorption layer. The sample pad, colloidal gold combination pad, chromatography membrane, and water absorption layer are arranged at the upper end of the rubber plate, and are connected in sequence. The chromatography membrane is provided with a detection line and a quality control line, and the colloidal gold combination pad is provided with a GP73 colloidal gold marker.

[0007] Further, the sample pad comprises a first sample pad body and a second sample pad body, the colloidal gold binding pad comprises a first colloidal gold binding pad body and a second colloidal gold binding pad body; wherein the first sample pad body and the second sample pad body are connected to form an integral, the first colloidal gold binding pad body and the second colloidal gold binding pad body are connected to form an integral, the first sample pad body is connected with the gel plate, the second sample pad body is connected with the gel plate through the first colloidal gold binding pad body, and the second colloidal gold binding pad body is connected with the chromatography membrane.

[0008] Further, a first gap exists between the first sample pad body and the first colloidal gold binding pad body, and a second gap exists between the first colloidal gold binding pad body and the chromatography membrane.

[0009] Further, the water absorption layer comprises a first water absorption layer body and a second water absorption layer body; wherein the first water absorption layer body and the second water absorption layer body are connected to form an integral, the first water absorption layer body is connected with the chromatography membrane, and the second water absorption layer body is connected with the gel plate.

[0010] Further, a third gap exists between the second water absorption layer body and the chromatography membrane.

[0011] Further, the utility model further comprises a shell, the gel plate is arranged in the bottom of the shell, a sample adding port is arranged on the upper end of the shell and corresponds to the position of the sample pad, and a judgment window is arranged on the upper end of the shell and corresponds to the detection line and the quality control line respectively.

[0012] Further, the shell comprises a clamping shell bottom plate and an outer cover, the sample pad, the colloidal gold binding pad, the chromatography membrane and the water absorption layer are arranged on the bottom of the clamping shell bottom plate through the gel plate, the outer cover is arranged on the upper end of the clamping shell bottom plate, and the sample adding port and the judgment window are arranged on the outer cover.

[0013] Further, the gel plate is a PVC gel plate.

[0014] Further, the chromatography membrane is a nitrocellulose membrane.

[0015] Further, the width of the first gap and the second gap is equal, and is arranged to be 1.5-2.5mm.

[0016] Compared with the prior art, the utility model has the beneficial effects that:

[0017] The utility model can detect through minimally invasive collection of fingertip blood, and can directly display the portal vein pressure detection result according to the detection line and the quality control line, the detection result can be used for evaluating the risk of serious complications such as digestive tract hemorrhage, and realizes early warning of liver portal hypertension. BRIEF DESCRIPTION OF DRAWINGS

[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description only show some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained from the structures shown in the drawings without creative labor.

[0019] Figure 1 It is a structure diagram of a minimally invasive portal vein pressure home test kit according to an embodiment of the utility model.

[0020] Figure 2 It is a detection flow chart of a minimally invasive portal vein pressure home test kit according to an embodiment of the utility model.

[0021] Figure 3 It is a semi-partial perspective view of a minimally invasive portal vein pressure home test kit according to an embodiment of the utility model, wherein T and C are used to indicate the positions of the detection line and the quality control line, and since the kit shown in the drawing has not been detected, the detection line and the quality control line are in a non-displayed state.

[0022] Figure 4 It is a manufacturing flow chart of a minimally invasive portal vein pressure home test kit according to an embodiment of the utility model.

[0023] Figure 5 It is a GP73 and HVPG correlation curve diagram according to an embodiment of the utility model.

[0024] In the drawing, 1 is a rubber plate, 2 is a sample pad, 21 is a first sample pad body, 22 is a second sample pad body, 3 is a colloidal gold combination pad, 31 is a first colloidal gold combination pad body, 32 is a second colloidal gold combination pad body, 4 is a chromatography film, 5 is a water absorption layer, 51 is a first water absorption layer body, 52 is a second water absorption layer body, 6 is a first gap, 7 is a second gap, 8 is a third gap, 9 is an outer shell, 91 is a sample adding port, 92 is an interpretation window, 93 is a clamping shell bottom plate, 94 is an outer cover, T is a detection line, and C is a quality control line. DETAILED DESCRIPTION

[0025] The embodiments of the present application will be described in detail through specific, concrete examples. Those skilled in the art can easily understand other advantages and effects of the present application from the content disclosed in the specification. The present application can also be implemented or applied through other different specific embodiments, and each detail in the specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present application. It should be noted that the following embodiments and features in the embodiments can be combined with each other without conflict.

[0026] In the description of the utility model, unless otherwise specified, the meaning of "a plurality of" is two or more than two;The terms "upper", "lower", "left", "right", "inner", "outer", "front end", "rear end", "head", "tail" and the like indicate the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the utility model and simplifying the description, and does not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, therefore it cannot be understood as a limitation on the utility model. In addition, the terms "first", "second", "third" and the like are only for the purpose of description, and cannot be understood as indicating or implying relative importance.

[0027] In the description of the utility model, it should be pointed out that, unless otherwise specified and limited, the terms "connected", "connected" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected;It can be mechanical connection, or electrical connection;It can be directly connected, or indirectly connected through an intermediate medium. For ordinary skilled persons in the art, the specific meaning of the above terms in the utility model can be understood according to the specific circumstances.

[0028] The utility model will be further described in conjunction with the drawings of the specification.

[0029] The utility model embodiment provides a kind of minimally invasive portal vein pressure home test kit, as shown in figure Figure 1 The minimally invasive portal vein pressure home test kit includes adhesive plate 1, sample pad 2, colloidal gold combination pad 3, chromatography film 4 and water absorption layer 5;Among them, sample pad 2, colloidal gold combination pad 3, chromatography film 4 and water absorption layer 5 are arranged at the upper end of adhesive plate 1, and sample pad 2, colloidal gold combination pad 3, chromatography film 4 and water absorption layer 5 are sequentially connected, chromatography film 4 is provided with detection line T and quality control line C, and colloidal gold combination pad 3 is provided with GP73 colloidal gold marker.

[0030] In the embodiment, based on the significant positive correlation of Golgi protein 73 (GP73) in blood to HPVG, a portal hypertension prediction means is developed, which is used as specific antigen, combined with specific colloidal gold antibody particles on the test kit. As shown in figure Figure 2 Fingertip blood is added to sample pad 2 through sample hole, and then sequentially enters colloidal gold combination pad 3, chromatography film 4 and water absorption layer 5, GP73 colloidal gold marker arranged on colloidal gold combination pad 3 reacts with fingertip blood, and then enters chromatography film 4, and the reaction result is displayed through detection line T and quality control line C on chromatography film 4, which usually has four cases, respectively:

[0031] The first case: detection line T and quality control line C are displayed, which indicates that the detection result is positive.

[0032] The second case: only the quality control line C is displayed, which indicates that the detection result is negative.

[0033] The third case: only the detection line T is displayed, which indicates that the detection result is invalid.

[0034] The fourth case: neither the detection line T nor the quality control line C is displayed, which indicates that the detection result is invalid.

[0035] It should be noted that positive means that the current detection result indicates that the detection result of the portal vein pressure exceeds the set threshold, which reminds that there is a risk of liver portal hypertension, negative means that the detection result of the portal vein pressure does not exceed the set threshold, which considers that the portal vein pressure is normal, and invalid means that the current detection is invalid, and the invalid reasons are, for example, improper operation, adding of non-target sample or problems in components in the kit, such as falling off of GP73 colloidal gold label or exceeding of the effective period of GP73 colloidal gold label.

[0036] In some embodiments, as shown in Figure 1 The sample pad 2 includes a first sample pad body 21 and a second sample pad body 22, and the colloidal gold binding pad 3 includes a first colloidal gold binding pad body 31 and a second colloidal gold binding pad body 32; wherein the first sample pad body 21 and the second sample pad body 22 are connected to form an integral body, the first colloidal gold binding pad body 31 and the second colloidal gold binding pad body 32 are connected to form an integral body, the first sample pad body 21 is connected with the gel plate 1, the second sample pad body 22 is connected with the gel plate 1 through the first colloidal gold binding pad body 31, and the second colloidal gold binding pad body 32 is connected with the chromatography membrane 4.

[0037] In this embodiment, the structure of the sample pad 2 and the colloidal gold binding pad 3 is optimized and designed to facilitate the assembly of the overall kit. Specifically, the sample pad 2 and the colloidal gold binding pad 3 adopt similar structures, i.e., a structure formed by connecting two straight plate segments with different heights through a curved segment. Through this design, the chromatography membrane 4 can be used as the basis for stacking the colloidal gold binding pad 3 and the sample pad 2 in sequence during installation.

[0038] Similarly, in order to facilitate the installation of the water absorption layer 5, the overall structure of the water absorption layer 5 is designed to be consistent with the structure of the sample pad 2 and the colloidal gold binding pad 3, as shown in Figure 1 The water absorption layer 5 includes a first water absorption layer body 51 and a second water absorption layer body 52; wherein the first water absorption layer body 51 and the second water absorption layer body 52 are connected to form an integral body, the first water absorption layer body 51 is connected with the chromatography membrane 4, and the second water absorption layer body 52 is connected with the gel plate 1.

[0039] Further, in order to better stack the sample pad 2, the colloidal gold binding pad 3, the chromatography membrane 4 and the water absorption layer 5 into one, a certain width gap is reserved between the above four components, that is, the first gap 6 exists between the first sample pad body 21 and the first colloidal gold binding pad body 31, the second gap 7 exists between the first colloidal gold binding pad body 31 and the chromatography membrane 4. The third gap 8 exists between the second water absorption layer body 52 and the chromatography membrane 4.

[0040] For example, the widths of the first gap 6, the second gap 7 and the third gap 8 can be equal or unequal. For the equal case, the widths of the first gap 6, the second gap 7 and the third gap 8 can be set as 1.5-2.5mm, preferably 2mm.

[0041] In some embodiments, the adhesive plate 1 can be selected as a PVC adhesive plate. The chromatography membrane 4 can be selected as a nitrocellulose membrane.

[0042] It should be noted that the above material limitations of the adhesive plate 1 and the chromatography membrane 4 are only examples and do not constitute a limitation on the present application. Meanwhile, PVC and nitrocellulose are both existing materials, and in some embodiments, other materials similar to these materials can be used for replacement.

[0043] In some embodiments, as shown in Figure 3 The minimally invasive portal vein pressure home test kit further comprises a shell 9, the adhesive plate 1 is arranged at the bottom of the shell 9, a sample adding port 91 is arranged at the upper end of the shell 9 corresponding to the position of the sample pad, a judgment window 92 is arranged at the upper end of the shell 9 corresponding to the detection line T and the quality control line C respectively, the shell 9 comprises a card shell bottom plate 93 and an outer cover 94, the sample pad 2, the colloidal gold binding pad 3, the chromatography membrane 4 and the water absorption layer 5 are arranged at the bottom of the card shell bottom plate 93 through the adhesive plate 1, the outer cover 94 is arranged at the upper end of the card shell bottom plate 93, and the sample adding port 91 and the judgment window 92 are arranged on the outer cover 94.

[0044] In the embodiment, the shell 9 plays a role of assembling the large plate structure formed by the adhesive plate 1, the sample pad 2, the colloidal gold binding pad 3, the chromatography membrane 4 and the water absorption layer 5, so as to arrange the large plate structure inside the card shell bottom plate 93, the outer cover 94 is used for sealing the card shell bottom plate 93, so as to protect the components inside the card shell bottom plate 93, the sample adding port 91 arranged on the outer cover 94 is used for adding samples, and the judgment window 92 is used for reading the detection result.

[0045] In order to further illustrate the feasibility and progressiveness of the present application, the preparation method, the use method, the detection experiment and the application description of the minimally invasive portal vein pressure home test kit will be provided in the following embodiments of the present application.

[0046] As shown in Figure 4As shown, it is a preparation flow chart of the minimally invasive portal vein pressure home test kit, which is prepared by the following steps:

[0047] Step 1, material preparation: gold mark pad (colloidal gold combined pad 3), water absorption paper (water absorption layer 5), sample pad, NC film (chromatography film 4), bottom plate (adhesive-free adhesive plate).

[0048] Step 2, draw film: the corresponding antigen antibody is sprayed on the NC film by a film drawing instrument to prepare the detection line and the quality control line.

[0049] Step 3, gold spraying: use the gold spraying pen of the gold spraying instrument to uniformly spray the GP73 colloidal gold marker on the gold mark pad.

[0050] Step 4, assembly: the NC film is pasted in the middle of the bottom plate, the gold mark pad and the sample pad are pasted in the lower part of the bottom plate in turn, and the water absorption paper is pasted in the upper part of the bottom plate. Each component retains a 2mm wide overlap between each other to make a large plate.

[0051] Step 5, cutting: place the prepared large plate into the cutting machine and set the cutting width to 3mm for cutting.

[0052] Step 6, card shell assembly: prepare the colloidal gold test paper plastic card shell, place the cut test paper strip in the groove of the card shell bottom plate, and cover the outer cover.

[0053] The use process of the minimally invasive portal vein pressure home test kit includes the following steps:

[0054] Step 10, disinfect the ring finger with a cotton swab dipped in medical alcohol

[0055] Step 20, use a blood collection needle to lightly prick the end of the ring finger to flow the blood from the tip of the finger

[0056] Step 30, use a sterile capillary tube to absorb blood until it rises to the scale line, and add it to the blood collection tube containing salt water.

[0057] Step 40, use a clean rubber head dropper to absorb 100μL of the mixture in the blood collection tube and drop it into the sample port.

[0058] Step 50, observe the test results after 15min, use a mobile phone APP to take a photo of the test paper and upload it, the AI system analyzes the big data and feeds back the results to the user APP, and gives clinical guidance according to the actual situation.

[0059] The embodiment also provides a GP73 protein colloidal gold marker acquisition step, which includes the following steps:

[0060] (1) Preparation of protein solvent to be labeled: dialyze the GP73 protein under appropriate conditions to remove excess salt ions, and remove polymers by high-speed centrifugation.

[0061] (2) Preparation of colloidal gold solvent to be labeled: adjust the pH value of the colloidal gold solution to a pH range suitable for GP73 protein labeling. For example, adjust to pH 9.0 for IgG labeling, and adjust to pH.

[0062] (3) Selection of optimal protein dosage: Determine the dosage ratio of colloidal gold to labeled protein. Through a series of dilution experiments, find the lowest protein dosage that can stabilize the colloidal gold solution, and increase it by 10%-20% to determine the actual dosage.

[0063] (4) Labeling: Mix the GP73 protein solution with the colloidal gold solution under conditions suitable for pH and ionic strength, and may need to add stabilizers such as BSA or PEG to prevent precipitation.

[0064] (5) Purification of colloidal gold protein: Purify the colloidal gold labeled protein by ultracentrifugation or gel filtration. Ultracentrifugation can use different centrifugal speeds and times according to the size of the colloidal gold particles and the stabilizer. Gel filtration is suitable for the purification of colloidal gold protein conjugates using BSA as a stabilizer.

[0065] (6) Identification of colloidal gold protein conjugate: Use transmission electron microscopy to measure the average diameter of colloidal gold particles, measure the OD520nm value of the colloidal gold solution, and use microfiltration membrane immunogold silver staining method (MF-IGSSA) to identify the specificity and sensitivity of the gold labeled protein.

[0066] The minimally invasive portal vein pressure home test kit has high specificity, high timeliness, convenient operation, and can allow patients to monitor at home, etc.

[0067] For high specificity, Golgi protein 73 (GP73) is a transmembrane protein on the cell Golgi. Previous studies have found that the level of GP73 in saliva is significantly positively correlated with HVPG, and the AUC of GP73 alone in the diagnosis of CSPH is 0.78. For example, Figure 5 Present.

[0068] After the patient obtains the test results in the kit, the real-time portal pressure prediction value of liver cirrhosis and upper gastrointestinal bleeding, the risk of serious complications such as gastrointestinal bleeding in patients is evaluated, early warning is realized, and the life safety of patients is maximized and most efficiently guaranteed, with a specificity of up to 96% or more.

[0069] For high timeliness, the minimally invasive portal vein pressure home test kit proposed in the embodiment can obtain results in 15 minutes, which is fast and efficient. The kit only needs to collect a small amount of finger blood for detection, and the operation is convenient, which is not only suitable for medical institutions, but also can be used for self-test at home.

[0070] For convenient operation, the utility model and other product detection methods have the following advantages: the hepatic venous pressure gradient (HVPG) determination, which is the only standard for predicting liver cirrhosis bleeding and decompensation in the market, is an invasive examination, has high technical requirements, is expensive, and is only carried out in a few centers, which limits its clinical promotion. The kit proposed by the utility model not only has low cost, but also breaks through the invasive limitation, realizes the minimally invasive detection technology, and is convenient and easy to operate, which breaks through the limitation that the current detection method can only be carried out in large hospitals and popularizes among the masses.

[0071] In addition, the utility model has wide application prospect. Specifically, cirrhosis is the terminal stage of the pathological process of various chronic liver diseases, and is a common and frequently-occurring disease in clinic. When it enters the decompensation stage, it is characterized by portal hypertension and severe damage to liver function. Significant portal hypertension (CSPH) indicates that the risk of varices, decompensation events and liver cancer in patients with compensated cirrhosis significantly increases. The number of deaths caused by cirrhosis reaches 1.16 million per year, which brings huge health and economic burden. Studies have confirmed that variceal bleeding caused by cirrhosis accounts for 40% of cirrhosis death causes; and once bleeding occurs, the mortality rate of patients is as high as 50%. Therefore, the examination for predicting cirrhosis bleeding has great clinical value.

[0072] The above embodiments are only used to illustrate the technical solutions of the utility model, but not limited thereto; although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that the technical solutions recorded in the foregoing embodiments can still be modified, or part or all of the technical features can be replaced equivalently; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the utility model, and they should be covered in the scope of the claims and the description of the utility model.

Claims

1. A minimally invasive home-based portal vein pressure monitoring kit, characterized in that, The device includes a gel plate, a sample pad, a colloidal gold binding pad, a chromatographic membrane, and an absorbent layer. The sample pad, colloidal gold binding pad, chromatographic membrane, and absorbent layer are disposed on the upper end of the gel plate and are connected in sequence. The chromatographic membrane is provided with a detection line and a quality control line, and the colloidal gold binding pad is provided with a GP73 colloidal gold marker.

2. The minimally invasive home portal vein pressure monitoring kit according to claim 1, characterized in that, The sample pad includes a first sample pad body and a second sample pad body, and the colloidal gold-binding pad includes a first colloidal gold-binding pad body and a second colloidal gold-binding pad body; wherein, the first sample pad body and the second sample pad body are connected to form an integral unit, the first colloidal gold-binding pad body and the second colloidal gold-binding pad body are connected to form an integral unit, the first sample pad body is connected to the gel plate, the second sample pad body is connected to the gel plate through the first colloidal gold-binding pad body, and the second colloidal gold-binding pad body is connected to the chromatography membrane.

3. The minimally invasive home portal vein pressure monitoring kit according to claim 2, characterized in that, There is a first gap between the first sample pad and the first colloidal gold-bound pad, and there is a second gap between the first colloidal gold-bound pad and the chromatography membrane.

4. The minimally invasive home portal vein pressure monitoring kit according to claim 1, characterized in that, The absorbent layer includes a first absorbent layer and a second absorbent layer; wherein the first absorbent layer and the second absorbent layer are connected to form an integral unit, the first absorbent layer is connected to the chromatography membrane, and the second absorbent layer is connected to the adhesive plate.

5. The minimally invasive home portal vein pressure monitoring kit according to claim 4, characterized in that, There is a third gap between the second absorbent layer and the chromatography membrane.

6. The minimally invasive home portal vein pressure monitoring kit according to claim 1, characterized in that, It also includes a housing, the adhesive plate is disposed at the bottom of the housing, the upper end of the housing is provided with a sample dispensing port corresponding to the position of the sample pad, and the upper end of the housing is provided with an interpretation window corresponding to the detection line and the quality control line respectively.

7. The minimally invasive home portal vein pressure monitoring kit according to claim 6, characterized in that, The outer casing includes a base plate and an outer cover. The sample pad, colloidal gold binding pad, chromatography membrane, and absorbent layer are disposed at the bottom of the base plate via the adhesive plate. The outer cover is disposed at the top of the base plate and has the sample dispensing port and the interpretation window.

8. The minimally invasive home portal vein pressure monitoring kit according to claim 1, characterized in that, The sheet is a PVC sheet.

9. The minimally invasive home portal vein pressure monitoring kit according to claim 1, characterized in that, The chromatography membrane is a nitrocellulose membrane.

10. The minimally invasive home portal vein pressure monitoring kit according to claim 3, characterized in that, The widths of the first and second gaps are equal, both set to 1.5~2.5mm.

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