[0023]In order to make the purpose, technical solutions and advantages of the embodiments of this application clearer, the technical solutions in the embodiments of this application will be described clearly and completely in conjunction with the drawings in the embodiments of this application. Obviously, the described embodiments It is a part of the embodiments of this application, but not all the embodiments. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of this application.
[0024]figure 1 It is a schematic diagram of the composition structure of the urinary catheter with antibacterial coating of the present invention. The urinary catheter is composed of a guiding part and a hand-held part. Among them, 1 is an opening, 2 is an elliptical soft head, 3 is a plastic ring, 4 is a diversion line, 5 is an inverted trapezoidal limiting part, 6 is an airbag, 7 is a sealing and fixing part, 8 is a water pipe, 9 is the inner tube body for urinary catheterization.
[0025]The guide part includes a guide tube and an elliptical soft head, an opening is provided in the middle of the top of the elliptical soft head, the upper part of the guide tube is connected with the elliptical soft head, and the lower end is The hand-held parts are connected, the diameter of the guide tube increases along the extending direction from the upper end to the lower end; the inner wall of the guide tube is vertically arranged with a plurality of guide lines vertically and horizontally on the outer wall of the guide tube. Shaping ring
[0026]The hand-held part includes an inverted trapezoidal limiting component, a socket is provided on the inverted trapezoidal limiting component for docking with the guide tube, and an inner urinary catheter body is provided in the middle of the inverted trapezoidal limiting component. The urinary tube is communicated with the guide tube through the socket; the hand-held part also includes two airbags and two water pipes. The airbags are respectively fixed on both sides of the hand-held part, and the two The water guide tube is located inside the hand-held part, and is located on both sides of the inner urinary catheterization tube body, one end of the water guide tube is connected to the airbag, and the other end is arranged in parallel with the inner urinary catheterization tube body;
[0027]A sealing and fixing part is provided at the lower outlet of the hand-held part, and three through holes are provided on the sealing and fixing part, and the inner catheter body and the two water guiding pipes pass through the through holes.
[0028]The urinary catheter with antibacterial coating of the present invention is provided with a plurality of shaping rings horizontally on the outer wall of the guide tube so that the urinary catheter has good elasticity and rigidity, and the elasticity gradually increases as the length of the guide tube increases. Reduced but gradually stronger rigidity, an elliptical soft head is arranged on the upper part of the guide tube, so that the guide tube is easy to turn, has sufficient longitudinal thrust, and is easy to enter the bent and blocked parts. By arranging a plurality of guide lines vertically and vertically on the inner wall of the guide tube, the antibacterial effect can be achieved by attaching antibacterial materials to the guide lines while draining.
[0029]figure 2It is a schematic diagram of the preparation process of the antibacterial coating of the present invention. A simple surface adsorption method can be used to load a layer of antibacterial drugs on the urinary catheter, but most of the drugs are released explosively at the initial stage of contact with body fluids. The initial concentration is too large and the sustained release performance is poor. This is not conducive to the recovery of the patient, nor Conducive to the continued antibacterial effect. The present invention will have antibacterial triclosan molecules (TCS, dichlorophenoxy chlorophen, C12H7C13Q2), effectively immobilized on the surface of the inner catheter body and the surface of the guide line to form a bacteriostatic coating. The raw material required for the preparation of the antibacterial coating is TCS with a purity of 97%; dopamine hydrochloride with a purity of 98%; anhydrous methanol and TRIS are both analytically pure; the diversion line is polyglycolic acid (PGA).
[0030]First, measure 150 mL of deionized water, add 182.1 mg of tris(hydroxymethylaminomethane) (TRIS) to the aqueous solution to adjust the pH of the solution to weakly alkaline, after the TRIS is stirred and dissolved, add dopamine hydrochloride according to the set ratio to form a PDA solution ; Then dissolve an appropriate amount of TCS in ethanol to form a TCS ethanol solution; mix the two solutions to form a mixed solution, seal the mouth and leave pores, and stir continuously. After 24h, cut the guide wire to an appropriate length, put it into the aforementioned mixed solution, and let it stand in an oven at 37°C for 24h. After taking it out, rinse it with deionized water and dry it to obtain a diversion wire with PDA-TCS coating. The surface morphology of the guide wire was observed by scanning electron microscope, and the change of surface composition was analyzed by electron energy spectrometer.
[0031]The guide wire with PDA-TCS coating was accurately weighed and put into 20 mL mixed phosphate buffered saline (PBS), and placed in an oven at 37°C. After soaking for 4 hours, 8 hours, 1 day, and 2 days, the corresponding guide wires were taken out, rinsed with deionized water to remove residual PBS buffer on the surface, and then placed in an oven for drying. After that, the residual TCS on the surface of the guide wire was extracted by ultrasonic treatment with methanol solution for 50 minutes, and the absorbance was measured by ultraviolet-visible absorption spectroscopy. The TCS content was calculated according to the standard curve and converted into the amount of TCS remaining after the surface of the guide wire was soaked. The standard curve is drawn using the absorption peak intensity of a known concentration of TCS methanol solution at about 280 nm in the ultraviolet-visible absorption spectrum.
[0032]The release of TCS is related to the TCS content of the coating. A coating with a relatively high TCS content releases nearly 60% of the TCS at the initial stage of immersion. However, coatings with relatively low TCS content release only about 40%. But with the extension of the immersion time, the relative amount of TCS released by the coating tends to be consistent. The reason may be that the first stage is the release of TCS close to the surface of the PDA coating, and then as time goes by, the TCS adsorbed on the PDA due to bonding is released as the PDA gradually degrades, and this The process proceeded relatively slowly. This release behavior shows that part of the TCS combined with PDA can exist in the coating more stably, while the coating degrades slowly, which is very beneficial for the long-term antibacterial effect of the diversion line.
[0033]In vitro antibacterial experiment was used to evaluate the antibacterial effect of the surface PDA-TCS coating. First dip a sterile cotton swab to take 1.5*106 cells/mL bacterial solution, and use the cotton swab to evenly smear the surface of the agar medium, repeat 3 times, rotate the plate 60° each time, and finally rotate 2 times around the periphery. After the water on the plane is completely absorbed by the agar, use sterile tweezers to place the sterilized guide wire on the solid medium plate. The distance between each sample is not less than 24mm, and the center of the sample is not less than 15mm from the edge. Post it within 15 minutes after bacterial inoculation. Then, they were cultured in a 37°C incubator for 1 day, 3 days, and 7 days respectively, and the range of the inhibition zone was observed to evaluate the antibacterial performance of the coated diversion wire.
[0034]Swab the Staphylococcus aureus colony evenly on the entire agar medium, and place a PDA-TCS-coated diversion line. At first, the colony will evenly fill the entire medium, but as the culture time increases, 3 The colonies around the diversion line disappeared after days. This indicates that the prepared coating has a certain antibacterial effect. Moreover, with the increase of the TCS load, the area of the antibacterial area around the diversion line has increased, which indicates the improvement of antibacterial performance. The coating has a killing effect on different kinds of bacteria.
[0035]In order to further verify the clinical effect of the urinary catheter with antibacterial coating of the present invention, we compared the test data of patients using the urinary catheter of the present invention and ordinary rubber catheter on the 3rd and 5th days. According to analysis, the difference in the incidence of urinary tract infection in patients using ordinary rubber catheters was not significant (P 0.149 and 0.054, respectively), but on the 10th day, the difference in the incidence of urinary tract infection in patients was significant (P =0.031), the incidence rate of the urethral catheter with antibacterial coating of the present invention is lower, that is to say, in the long-term indwelling catheterization, the catheter with antibacterial coating of the present invention is used for indwelling urinary catheterization The incidence of later urinary tract infections of patients is lower than that of ordinary rubber catheters.
[0036]
[0037]On the basis of the above-mentioned tests, we have also carried out corresponding tests for patients with combined urethral injury. In the same way as the previous test, patients who choose new catheters and ordinary rubber catheters for indwelling catheters are on the third day. On the 5th and 10th day, the differences in the incidence of urinary tract infections were not significant (P all>0.05), but the incidence of urinary tract infection is still higher in patients who choose ordinary rubber catheter for indwelling urinary catheterization.
[0038]From the above data, it can be seen that the urinary catheter with antibacterial coating of the present invention has a good antibacterial effect, and can solve the problem of re-catheterization for patients who failed the first catheterization to a certain extent. The test results reflect , The incidence of urinary tract infections on the 10th day of indwelling catheterization in patients who use catheters with antibacterial coatings is significantly lower than that of ordinary rubber catheters.
[0039]Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the application, not to limit them; although the application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: The technical solutions recorded in the foregoing embodiments are modified, or some of the technical features are equivalently replaced; these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present application.
