A drainage tube capable of monitoring pressure and suppressing inflammatory response simultaneously

Abstract

The application discloses a drainage tube capable of monitoring pressure and inhibiting inflammatory reaction simultaneously, and belongs to the technical field of medical devices, which comprises a drainage catheter, a pressure monitoring system and a pH response coating, an internal drainage passage and a line passage are arranged in the drainage catheter, a pH response coating is arranged on the circumference of the drainage catheter in contact with tissues, a pressure sensor is further arranged at the front end of the drainage catheter, the pressure sensor transmits a pressure signal through a pressure sensor transmission line after sensing pressure change in a body cavity, the pressure sensor transmission line is connected with a pressure display, and the pH response coating can improve a wound environment, prevent bacterial propagation and reduce the risk of inflammatory reaction. The drainage tube can not only complete drainage but also inhibit postoperative inflammatory reaction, can monitor pressure in the body cavity simultaneously, is helpful to postoperative wound healing of a patient and is convenient for medical staff to judge the recovery condition of the patient after operation.

Description

Technical Field

[0001] This invention relates to a drainage tube, specifically a drainage tube that can simultaneously monitor pressure and suppress inflammatory responses, belonging to the field of medical device technology. Background Technology

[0002] Surgical drainage tubes are used to drain blood, pus, tissue fluid, and other fluids from wounds during or after surgery. Surgical drainage is used in almost all surgical procedures and wound healing, such as thoracic surgery for bronchopleural or esophageal fistulas, abdominal surgery for pancreatic rupture, orthopedic surgery for fractures, neurosurgery for intracranial hemorrhage, gynecology and obstetrics for endometrial cancer, and breast and thyroid surgery for breast cancer.

[0003] Reports indicate that intact skin naturally has an acidic environment, with a pH value between 4 and 6. However, when skin is injured, due to microvascular leakage, the pH value at the wound site increases, approaching the physiological pH value (7.4) needed for bacterial infection. When the pH value reaches between 7.5 and 8.9, an inflammatory response can occur, leading to prolonged healing time. Therefore, restoring the acidic environment at the wound site can effectively prevent bacterial growth and reduce the risk of inflammatory responses.

[0004] Furthermore, intra-abdominal pressure is a crucial indicator for physicians to assess a patient's recovery. Systemic inflammatory response syndrome (SIRS) is commonly associated with surgical procedures, especially major abdominal surgery, where SIRS patients exhibit elevated intra-abdominal pressure. Studies have shown that using a 12 mmHg standard, 32.8% of patients in the early postoperative period after major abdominal surgery experienced intra-abdominal hypertension. While existing drainage tubes can assist physicians in draining postoperative pus and tissue fluid, they lack the function of monitoring intra-abdominal pressure and suppressing wound inflammation. Summary of the Invention

[0005] In view of the above problems, the object of the present invention is to provide a drainage tube that can simultaneously monitor pressure and suppress inflammatory response.

[0006] The present invention provides a drainage tube that can simultaneously monitor pressure and inhibit inflammatory response, comprising a drainage catheter, a pressure monitoring system, and a pH-responsive coating. The drainage catheter has a drainage channel and a circuit channel inside. The periphery of the drainage catheter in contact with the tissue is provided with a pH-responsive coating. A pressure sensor is also provided at the front end of the drainage catheter.

[0007] Furthermore, the pH-responsive coating described above is a gel polymer, polymerized from 3-(trimethoxysilane)propyl acrylate and acrylic acid, and the specific preparation method is as follows:

[0008] (1) 11.5g 3-(trimethoxysilane)propyl acrylate, 4g acrylic acid, 0.04g N,N ，- Methylenebisacrylamide and 0.5g of 1-[4-(2-hydroxyethoxy)-phenyl]-2-hydroxy-2-methylpropanone (2959) photoinitiator were dissolved in N,N-dimethylformamide and stirred until homogeneous to obtain a gel solution;

[0009] (2) Coat the outer wall of the drainage tube evenly with the gel solution obtained in the first step and irradiate it under ultraviolet light for 30-60 seconds.

[0010] Furthermore, the drainage catheter is an asymmetrical double-lumen drainage catheter, wherein the lead wire channel serves as the channel for the pressure sensor transmission line.

[0011] Furthermore, the pressure sensor is embedded in the front end of the drainage catheter and is in direct contact with the fluid or tissue within the body cavity. Except for the sensing part, the rest of the pressure sensor is wrapped by the drainage catheter.

[0012] Furthermore, the pressure sensor is preferably a high-precision pressure sensor. After sensing the pressure change within the body cavity, the pressure sensor outputs a pressure signal through a pressure sensor transmission line, which is connected to a pressure display.

[0013] Furthermore, the pressure monitoring system includes a pressure sensor, leads, and a pressure display. The pressure sensor is connected to the pressure display via a pressure sensor transmission line within a conduit. The pressure display includes a signal processing unit, a pressure display unit, and an alarm unit. The signal processing unit is connected to the pressure display unit, and the pressure display unit is connected to the alarm unit.

[0014] Furthermore, when the pressure reading on the pressure display unit exceeds 12 mmHg, the alarm unit is triggered, emitting a 'beep beep' sound.

[0015] Furthermore, the cross-section of the drainage tube is one or two of the following: circular, I-shaped, or cross-shaped.

[0016] The beneficial effects of this invention, which allows for simultaneous monitoring of pressure and inhibition of inflammatory responses through a drainage tube, are:

[0017] 1. By setting up a pressure sensor, the pressure sensor can be inserted into the patient's body cavity along with the drainage tube. While the drainage tube drains postoperative tissue fluid and waste fluid from the patient's body cavity, the pressure sensor can also detect the pressure inside the body cavity by contacting it, thus evaluating the patient's postoperative recovery.

[0018] 2. The outer wall of the drainage tube is coated with a pH-responsive polymer, which can regulate the wound microenvironment, restore the acidic environment of the wound site, effectively prevent bacterial growth, reduce the risk of inflammatory response, and help wound healing;

[0019] 3. The outer wall of the drainage tube is coated with a pH-responsive polymer, which can enhance the breaking strength of the drainage tube. Attached Figure Description

[0020] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 A schematic diagram of a drainage tube that can simultaneously monitor pressure and suppress inflammatory responses;

[0022] Figure 2 A cross-sectional view of a drainage tube that can simultaneously monitor pressure and suppress inflammatory response;

[0023] Figure 3 The curves show the changes in pH value in infected wounds, non-infected wounds, and normal wounds during the healing process;

[0024] In the diagram: 1-drainage catheter, 2-lead wire, 3-pressure indicator, 4-pressure sensor, 5-pH-responsive coating, 6-line channel, 7-drainage channel. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of the present invention. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of protection of the present invention, but merely to indicate selected embodiments of the present invention; all embodiments based on the present invention are within the protection scope of the present invention.

[0026] The following is combined with Figure 1 and Figure 2 The specific embodiments of the present invention will be further described below. The present invention provides a drainage tube capable of simultaneously monitoring pressure and inhibiting inflammatory responses, comprising a drainage catheter 1, a pressure monitoring system, and a pH-responsive coating 5. The drainage catheter 1 has a drainage channel 7 and a wiring channel 6 internally. The outer wall of the drainage catheter is coated with a pH-responsive coating 5, which is a gel-like polymer containing a large amount of -COOH, responding to alkaline environments. During postoperative wound hemostasis and inflammation, it releases H... +This lowers the pH value. A pressure sensor 4 is installed at the tip of the drainage catheter 1, and the pressure sensor 4 is connected to a pressure display 3 via a lead wire 2. The pressure sensor 4, lead wire 2, and pressure display 3 constitute a pressure monitoring system, where the pressure display 3 includes a signal processing unit, a pressure display unit, and an alarm unit. The signal processing unit is connected to the pressure display unit, and the pressure display unit is connected to the alarm unit. When the value in the pressure display unit exceeds 12 mmHg, the alarm unit is triggered, emitting a 'beep' sound. This serves as a warning to medical personnel if the pH-responsive coating fails to suppress wound inflammation or edema, leading to excessive intracavitary pressure.

[0027] The following exemplary embodiments further illustrate this point:

[0028] In the examples and comparative examples, the silicone tubes used were of grades MCH-3050-60 and MCH-3050-70, the developer was BaSO4 (Type I), and the curing agents were bis24 and bis25.

[0029] Example:

[0030] Fabrication of Fr14 double-lumen drainage tubes. The main body rubber and color line rubber of the drainage tube are mixed evenly and then placed into different feed troughs of a silicone extruder. A 4.7 nozzle and a 1.0 / 2.8 core are selected. The extrusion speeds are adjusted to 200 rpm and 30 rpm respectively, and the vulcanization temperature is 500℃.

[0031] Preparation process of gel polymers. Take 11.5g of 3-(trimethoxysilane)propyl acrylate, 4g of acrylic acid, and 0.04g of N,N ， - Methylenebisacrylamide and 0.5g of 1-[4-(2-hydroxyethoxy)-phenyl]-2-hydroxy-2-methylpropanone (2959) photoinitiator were dissolved in 10ml of N,N-dimethylformamide and stirred until a gel solution was obtained.

[0032] The obtained gel solution was uniformly coated onto the outer wall of the drainage tube and irradiated under a UV lamp for 30-60 seconds. The reaction molecular formula after photocuring is as follows:

[0033]

[0034] The following is a comparison.

[0035] Comparative example:

[0036] The Fr14 double-lumen drainage tube was fabricated using the same drainage tube fabrication process as in the example, without any coating.

[0037] 1. pH responsiveness test:

[0038] The pH changes in infected wounds, non-infected wounds, and normal wounds during the healing process are shown in the curves. Figure 3 As shown. To simulate the alkaline microenvironment of an infected wound in vitro, four small beakers were filled with PBS (100 mmol / L) at pH 7.4. . L -1 The solution was then added dropwise with 0.2 mol. . L -1 A sodium hydroxide solution was used to maintain the pH of the solution in each beaker between 7.5 and 8.0. Multiple batches of drainage tubes were prepared according to the method described in the examples, and named Example Sample 1, Example Sample 2, and Example Sample 3, respectively. The drainage tubes prepared by the comparative method were named Comparative Samples. All drainage tubes were 20 cm long and were placed in four beakers respectively. They were incubated at room temperature for 2 hours, and then the pH change of the solution in each beaker was measured.

[0039] Table 1: pH test results.

[0040]

[0041] 2. Coating adhesion test:

[0042] Three drainage tubes were taken from the example and installed in the clamping grooves of the clamping system using clips. The distance between the two sliding clamps was adjusted to 40cm, and then the clips were tightened to ensure a good fit between the drainage tube clips. One end of the test tube was passed through the two tube clips from bottom to top, and the upper clamp of the testing instrument held the head end of the drainage tube. The remaining part of the drainage tube was inserted into a cylinder filled with water at a temperature of (37±1)℃, and allowed to immerse naturally for 1 minute. The positions of the two sliding clamps in the grooves were adjusted so that the tube was in the center, the clamping force was 3 N, and the lifting speed was 200mm / min. The testing instrument was started so that the wetted part of the tube passed through the silicone sheet for 15cm, and the force versus displacement curve was recorded. The average force value of the wetted section of the drainage tube on the curve was taken as the frictional force.

[0043] The method for calculating the durability after 30 friction tests is as follows:

[0044] Strength = U2 / U1

[0045] Where U1 is the average friction coefficient of the first 5 times, and U2 is the average friction coefficient of the last 5 times, the ratio of the two to 1 can be used to judge the coating adhesion. The closer the ratio is to 1, the more adhesion the coating is.

[0046] Table 2: Results of coating adhesion test.

[0047]

[0048] 3. Fracture force performance test

[0049] Three drainage tubes were used for the examples and comparative examples. Each drainage tube was immersed in water at (37±2)℃ for 2 hours to allow for conditioning. Both ends of a test segment were clamped onto suitable fixtures of a tensile testing instrument at a clamping distance of 20mm. The testing speed was 400mm / min. Tensile force was applied until the test segment was divided into two or more parts. The applied force value was recorded in Newtons.

[0050] Table 3: Fracturing force test results

[0051]

[0052] In summary, the drainage tube of the embodiment can play a role in pH regulation, lowering the pH value when the pH value rises due to wound inflammation, inhibiting bacterial growth, and the coating is firm, which also improves the breaking strength of the drainage tube with the coating.

Claims

1. A drainage tube capable of simultaneously monitoring pressure and suppressing inflammatory responses, characterized in that, The device includes a drainage catheter, a pressure monitoring system, and a pH-responsive coating. The drainage catheter has internal drainage channels and wiring channels. A pH-responsive coating is applied around the periphery of the drainage catheter where it contacts tissue. A pressure sensor is also located at the tip of the drainage catheter. The pH-responsive coating is a gel polymer, polymerized from 3-(trimethoxysilane)propyl acrylate and acrylic acid. The specific preparation method is as follows: (1) 11.5g 3-(trimethoxysilane)propyl acrylate, 4g acrylic acid, 0.04g N,N ， - Methylenebisacrylamide, 0.5g of 1-[4-(2-hydroxyethoxy)-phenyl]-2-hydroxy-2-methylpropanone were dissolved in N,N-dimethylformamide and stirred until homogeneous to obtain a gel solution; (2) Coat the obtained gel solution evenly on the outer wall of the drainage tube and irradiate it under ultraviolet light for 30-60s.

2. The drainage tube according to claim 1, capable of simultaneously monitoring pressure and inhibiting inflammatory response, is characterized in that, The drainage conduit is an asymmetrical double-lumen drainage tube, in which the circuit channel serves as the channel for the pressure sensor transmission line.

3. The drainage tube according to claim 1, capable of simultaneously monitoring pressure and inhibiting inflammatory response, is characterized in that, The pressure sensor is embedded in the front end of the drainage catheter and is in direct contact with the fluid or tissue in the body cavity. Except for the sensing part, the rest of the pressure sensor is wrapped by the drainage catheter.

4. The drainage tube according to claim 1, capable of simultaneously monitoring pressure and inhibiting inflammatory response, is characterized in that, The pressure monitoring system includes a pressure sensor, leads, and a pressure display. The pressure sensor is connected to the pressure display via leads inside the drainage conduit. The pressure display includes a signal processing unit, a pressure display unit, and an alarm unit.

5. The drainage tube according to claim 4, capable of simultaneously monitoring pressure and inhibiting inflammatory response, is characterized in that, The alarm unit is triggered when the pressure reading on the pressure display unit exceeds 12 mmHg.

6. The drainage tube according to claim 1, capable of simultaneously monitoring pressure and inhibiting inflammatory response, is characterized in that, The cross-section of the drainage tube is one or two of the following: circular, I-shaped, and cross-shaped.

Images