A peritonitis early warning device and method integrated into a peritoneal dialysis waste bag

Abstract

The application discloses a peritonitis early warning device and method integrated with a peritoneal dialysis waste liquid bag, which comprises a dialysis liquid bag, a waste liquid bag and a tee pipe, the tee pipe is connected with the dialysis liquid bag and the waste liquid bag through a first conduit and a second conduit respectively, and the waste liquid bag is internally provided with a visual detection device and an immunological detection device; the waste liquid bag is internally provided with a sealed interlayer, and the immunological detection device is arranged in the sealed interlayer; the immunological detection device comprises absorbing cotton and a detection strip, and the detection strip is provided with a quality control line and a detection line; the visual detection device comprises an observation window arranged on the transparent front outer surface of the waste liquid bag, and a garbled code card fixed to the rear inner surface of the waste liquid bag. The application has the beneficial effects that the detection strip is used to observe whether the to-be-detected antigen exists in the peritoneal dialysis liquid, and the visual detection device is used to observe whether the peritoneal dialysis liquid is turbid. If the to-be-detected antigen or the peritoneal dialysis liquid is detected, it is indicated that peritonitis may occur, and the patient is reminded to go to a hospital as soon as possible.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a peritonitis early warning device and method integrated into a peritoneal dialysis waste bag. Background Technology

[0002] As living standards gradually improve, the incidence of kidney disease also increases. Currently, there are two dialysis methods for patients with kidney failure: hemodialysis and peritoneal dialysis. For patients with chronic kidney disease, peritoneal dialysis is clinically recommended as the first-line treatment. Patients only need a permanent dialysis catheter inserted into their abdominal cavity to perform peritoneal dialysis at home, greatly reducing the frequency of trips to the hospital.

[0003] However, peritoneal dialysis patients require a high degree of sterility in their home dialysis room and need to weigh and record their peritoneal dialysis fluid daily for their next follow-up visit. A small number of patients fail to maintain aseptic technique at home, allowing bacteria to easily enter the abdominal cavity and cause peritonitis. Early-stage peritonitis is difficult to detect at home, and patients often only seek medical attention when they experience significant fever, severe abdominal pain, or cloudy peritoneal dialysis fluid. By this time, the peritonitis has progressed to a stage that is difficult to treat, increasing the difficulty and duration of treatment. Therefore, there is an urgent need for an early home peritonitis detection and warning device. Summary of the Invention

[0004] In view of the above-mentioned defects in the existing technology, the present invention provides a peritonitis early warning device and method integrated into the peritoneal dialysis waste bag, so that patients can make a preliminary judgment on whether peritonitis has occurred after peritoneal dialysis treatment.

[0005] The technical solution adopted by the present invention is as follows: a peritonitis early warning device integrated into a peritoneal dialysis waste bag, comprising a dialysis bag, a waste bag and a three-way tube, wherein the three-way tube is connected to the dialysis bag and the waste bag respectively through a first conduit and a second conduit, and the waste bag is provided with a visual detection device and an immunological detection device. The waste fluid bag has a sealed interlayer, and the immunological detection device is located within the sealed interlayer. The immunological detection device includes absorbent cotton and a test strip. The absorbent cotton is located at the boundary of the sealed interlayer, with one end in contact with the peritoneal dialysis fluid in the waste fluid bag and the other end in contact with the test strip, for guiding the peritoneal dialysis fluid in the waste fluid bag to the test strip. The test strip has a control line on the side closer to the absorbent cotton and a test line on the side farther from the absorbent cotton. The visual inspection device includes a transparent observation window on the outer front surface of the waste liquid bag and a random code card fixed on the inner rear surface of the waste liquid bag, the position of the random code card being matched with the observation window.

[0006] According to the above technical solution, the test strip also includes a gold-labeled pad and a biotinylated chemical pad, which are disposed between the quality control line and the absorbent cotton. The gold-labeled pad is coated with colloidal gold-labeled NGAL monoclonal antibody, and the biotinylated chemical pad is coated with biotinylated NGAL monoclonal antibody.

[0007] According to the above technical solution, the control line is coated with goat anti-rabbit IgG antibody, which can bind to colloidal gold-labeled NGAL monoclonal antibody, making the control line appear as a red band; the test line is coated with streptavidin, which, when the peritoneal dialysis fluid contains NGAL, binds to colloidal gold-labeled NGAL monoclonal antibody and biotin-labeled NGAL monoclonal antibody to form a complex. The complex moves under chromatography and binds to streptavidin, making the test line appear as a red band.

[0008] According to the above technical solution, the surface of the garbled card is printed with several garbled characters of different sizes.

[0009] According to the above technical solution, several of the garbled characters are arranged in descending or ascending order.

[0010] According to the above technical solution, the dialysis fluid bag is provided with a liquid addition tube, and the opening of the liquid addition tube is provided with a tube cap.

[0011] According to the above technical solution, the cap and the liquid filling pipe are connected by threads.

[0012] According to the above technical solution, the first catheter and the second catheter are equipped with medical catheter clamps.

[0013] The present invention also discloses an early warning method based on the device described above, the method comprising: S1. The patient receives peritoneal dialysis fluid into the peritoneal cavity for treatment. After the treatment, the peritoneal dialysis fluid in the peritoneal cavity is drained into the waste bag. S2. Check the clarity of the garbled card through the observation window to determine the turbidity of the peritoneal dialysis fluid; S3. Observe the color change of the test strip to determine whether the immunological test is positive; S4. If at least one of the following occurs: turbid peritoneal dialysis fluid or a positive test strip, it indicates that the patient may have peritonitis, and the patient should seek medical attention promptly.

[0014] According to the above technical solution, a color change in the control line of the test strip indicates that the test result is valid; a color change in the test line indicates that the peritoneal dialysis fluid contains the antigen to be tested, and the test result is positive.

[0015] The present invention has the following beneficial effects: 1. The device described in this invention includes a visual detection device and an immunological detection device. After a patient completes peritoneal dialysis at home, the peritoneal dialysis fluid is drained into a waste bag. The device uses a test strip to observe whether the peritoneal dialysis fluid contains the antigen to be tested, and also uses the visual detection device to observe whether the peritoneal dialysis fluid is turbid. If the antigen to be tested is detected or the peritoneal dialysis fluid is turbid, it indicates that peritonitis may have occurred, reminding the patient to seek medical attention as soon as possible.

[0016] 2. The test strip of this invention contains an IgG antibody on the control line, which can bind to a colloidal gold-labeled NGAL monoclonal antibody, turning the control line red. The test line contains streptavidin, which, when NGAL is present in the peritoneal dialysis fluid, binds to the colloidal gold-labeled NGAL monoclonal antibody and the biotin-labeled NGAL monoclonal antibody to form a complex. This complex binds to streptavidin under chromatographic action, turning the test line red. A color change in the control line indicates a valid test result, while a positive color change in the test line indicates the detection of NGAL, suggesting the possible presence of peritonitis in the patient.

[0017] 3. The present invention has several random characters of different sizes printed on the surface of the random character card. Patients can view the clarity of the random characters of different sizes through the observation window and peritoneal dialysis fluid, thereby accurately judging whether the peritoneal dialysis fluid is turbid. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of a peritonitis early warning device integrated into a peritoneal dialysis waste bag in an embodiment of the present invention.

[0019] In the diagram: 1. Dialysis fluid bag; 2. Waste fluid bag; 3. Three-way connector; 4. First catheter; 5. Second catheter; 6. Sealing interlayer; 7. Absorbent cotton; 8. Test strip; 9. Quality control line; 10. Test line; 11. Observation window; 12. Random code card; 13. Fluid addition tube; 14. Tube cap. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0021] Example 1: This example provides a peritonitis early warning device integrated into the peritoneal dialysis waste bag 2, such as... Figure 1 As shown, it includes a dialysate bag 1, a waste liquid bag 2, and a three-way tube 3. The three-way tube 3 is connected to the dialysate bag 1 and the waste liquid bag 2 through a first conduit 4 and a second conduit 5, respectively. The waste liquid bag 2 is equipped with a visual detection device and an immunological detection device.

[0022] In this embodiment, a sealed interlayer 6 is provided inside the waste fluid bag 2, and the immunological detection device is disposed within the sealed interlayer 6. The immunological detection device includes absorbent cotton 7 and a test strip 8. The absorbent cotton 7 is located at the boundary of the sealed interlayer 6. One end of the absorbent cotton 7 extends into the waste fluid bag 2 and contacts the peritoneal dialysis fluid inside the waste fluid bag 2, while the other end extends into the sealed interlayer 6 and contacts the test strip 8. The absorbent cotton 7 can guide the peritoneal dialysis fluid in the waste fluid bag 2 to the test strip 8. The test strip 8 has a control line 9 on the side near the absorbent cotton 7 and a test line 10 on the side away from the absorbent cotton 7.

[0023] In this embodiment, test strip 8 uses gold-labeled immunochromatography to detect neutrophil gelatinase-associated lipotransferase (NGAL) in peritoneal dialysis fluid. The test strip also includes a gold-labeled pad and a biotinylated pad, positioned between the control line 9 and the absorbent cotton 7. The gold-labeled pad is coated with colloidal gold-labeled NGAL monoclonal antibody, and the biotinylated pad is coated with biotinylated NGAL monoclonal antibody.

[0024] In this embodiment, control line 9 (C line) is coated with goat anti-rabbit antibody (IgG), and test line 10 (T line) is coated with streptavidin. Absorbent cotton 7 drains the peritoneal dialysis fluid from waste bag 2 to test strip 8. Regardless of whether the sample contains the NGAL antigen to be tested, the colloidal gold-labeled NGAL monoclonal antibody can bind to the goat anti-rabbit IgG antibody, causing the control line to appear as a red band. A red control line 9 indicates a valid test result; if the control line 9 does not change color, the test result is invalid. If the peritoneal dialysis fluid sample contains neutrophil gelatinase-associated lipotransferase (NGAL), NGAL will first bind to the colloidal gold-labeled NGAL monoclonal antibody and the biotin-labeled NGAL monoclonal antibody to form a complex. This complex will move towards test line 10 under chromatography and bind to streptavidin, causing the test line to appear as a red band, indicating a positive test result. When a patient is undergoing peritoneal dialysis at home, a red control line (line 9) indicates a valid test result. A red test line (line 10) indicates a positive result, which may indicate peritonitis. Patients should seek medical attention as soon as possible.

[0025] In this embodiment, the visual inspection device includes a transparent observation window 11 disposed on the outer surface of the front side of the waste liquid bag 2, and a random code card 12 fixed on the inner surface of the rear side of the waste liquid bag 2. The position of the random code card 12 is matched with the observation window 11, and the random code card 12 can be viewed through the observation window 11.

[0026] In this embodiment, the surface of the garbled card 12 is printed with several garbled characters of varying sizes, arranged in descending or ascending order. The patient can view the garbled characters on the garbled card 12 through the observation window 11, looking through the peritoneal dialysis fluid. If the garbled characters are clearly visible, the peritoneal dialysis fluid is preliminarily judged to be clear; if the garbled characters are blurry, the peritoneal dialysis fluid is preliminarily judged to be turbid. The garbled characters are set to varying sizes, allowing the patient to compare and improve the accuracy of the judgment.

[0027] In this embodiment, the dialysis bag 1 is equipped with a fluid inlet tube 13, and the inlet of the fluid inlet tube 13 is equipped with a tube cap 14. The tube cap 14 is detachably connected to the fluid inlet tube 13 via threads. Medical staff and patients can conveniently add medications and peritoneal dialysis fluid through the fluid inlet tube 13 and tighten the tube cap 14 to prevent leakage.

[0028] In this embodiment, medical catheter clamps can be added to the first catheter 4 and the second catheter 5, which can control the flow of peritoneal dialysis fluid and also play a fixing role, ensuring stability and safety during the treatment process.

[0029] Example 2 This embodiment utilizes the device described in Embodiment 1 to provide a peritonitis early warning method, the method comprising: S1. The patient infuses peritoneal dialysis fluid into the peritoneal cavity and retains it for several hours. Using the peritoneum as a semipermeable membrane, metabolic waste and excess water are removed from the body through diffusion and ultrafiltration. After the treatment, the peritoneal dialysis fluid in the peritoneal cavity is drained into waste fluid bag 2.

[0030] S2. Check the clarity of the garbled card 12 through the observation window 11 to determine the turbidity of the peritoneal dialysis fluid; S3. Observe the color change of test strip 8 to determine whether the immunological test is positive; In step S3, if the control line 9 of test strip 8 changes color, it indicates that the test result is valid; if the test line 10 changes color based on the change in the control line 9, it indicates that the peritoneal dialysis fluid contains the antigen to be tested, and the test result is positive.

[0031] S4. If at least one of the following occurs: turbid peritoneal dialysis fluid or positive result on test strip 8, it indicates that the patient may have peritonitis, and the patient should seek medical attention promptly.

[0032] The embodiments described above are some, but not all, of the embodiments of this application. The detailed description of the embodiments of this application is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

Claims

1. A peritonitis early warning device integrated into a peritoneal dialysis waste bag, comprising a dialysis fluid bag, a waste fluid bag, and a three-way connector, wherein the three-way connector is connected to the dialysis fluid bag and the waste fluid bag respectively via a first conduit and a second conduit, characterized in that: The waste liquid bag is equipped with a visual inspection device and an immunological detection device. The waste fluid bag has a sealed interlayer, and the immunological detection device is located within the sealed interlayer. The immunological detection device includes absorbent cotton and a test strip. The absorbent cotton is located at the boundary of the sealed interlayer, with one end in contact with the peritoneal dialysis fluid in the waste fluid bag and the other end in contact with the test strip, for guiding the peritoneal dialysis fluid in the waste fluid bag to the test strip. The test strip has a control line on the side closer to the absorbent cotton and a test line on the side farther from the absorbent cotton. The visual inspection device includes a transparent observation window on the outer front surface of the waste liquid bag and a random code card fixed on the inner rear surface of the waste liquid bag, the position of the random code card being matched with the observation window.

2. The peritonitis early warning device integrated into a peritoneal dialysis waste bag according to claim 1, characterized in that: The test strip also includes a gold-labeled pad and a biotinylated chemical pad, which are located between the quality control line and the absorbent cotton. The gold-labeled pad is coated with colloidal gold-labeled NGAL monoclonal antibody, and the biotinylated chemical pad is coated with biotinylated NGAL monoclonal antibody.

3. The peritonitis early warning device integrated into a peritoneal dialysis waste bag according to claim 2, characterized in that: The control line is coated with goat anti-rabbit IgG antibody, which can bind to colloidal gold-labeled NGAL monoclonal antibody, making the control line appear as a red band. The test line is coated with streptavidin. When the peritoneal dialysis fluid contains NGAL, it binds to colloidal gold-labeled NGAL monoclonal antibody and biotin-labeled NGAL monoclonal antibody to form a complex. The complex moves under chromatography and binds to streptavidin, making the test line appear as a red band.

4. The peritonitis early warning device integrated into a peritoneal dialysis waste bag according to claim 1, characterized in that: The surface of the garbled card is printed with several garbled characters of varying sizes.

5. The peritonitis early warning device integrated into a peritoneal dialysis waste bag according to claim 4, characterized in that: Several of the garbled characters are arranged in descending or ascending order.

6. The peritonitis early warning device integrated into a peritoneal dialysis waste bag according to claim 1, characterized in that: The dialysate bag is equipped with a liquid addition tube, and the end of the liquid addition tube is equipped with a tube cap.

7. A peritonitis early warning device integrated into a peritoneal dialysis waste bag according to claim 6, characterized in that: The cap is connected to the liquid filling tube by a thread.

8. The peritonitis early warning device integrated into a peritoneal dialysis waste bag according to claim 1, characterized in that: The first and second catheters are equipped with medical catheter clamps.

9. A method for early warning of peritonitis using a peritonitis early warning device integrated into a peritoneal dialysis waste bag as described in any one of claims 1 to 8, characterized in that, The method includes: S1. The patient receives peritoneal dialysis fluid into the peritoneal cavity for treatment. After the treatment, the peritoneal dialysis fluid in the peritoneal cavity is drained into the waste bag. S2. Check the clarity of the garbled card through the observation window to determine the turbidity of the peritoneal dialysis fluid; S3. Observe the color change of the test strip to determine whether the immunological test is positive; S4. If at least one of the following occurs: turbid peritoneal dialysis fluid or a positive test strip, it indicates that the patient may have peritonitis, and the patient should seek medical attention promptly.

10. The early warning method according to claim 9, characterized in that: A color change in the control line of the test strip indicates that the test result is valid; a color change in the test line indicates that the peritoneal dialysis fluid contains the antigen to be tested, and the test result is positive.

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